[Federal Register Volume 64, Number 180 (Friday, September 17, 1999)]
[Proposed Rules]
[Pages 50672-50730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24181]
[[Page 50671]]
_______________________________________________________________________
Part IV
Environmental Protection Agency
_______________________________________________________________________
40 CFR Parts 152 and 156
Registration Requirements for Antimicrobial Pesticide Products and
Other Pesticide Regulatory Changes; Proposed Rule
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /
Proposed Rules
[[Page 50672]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 152 and 156
[OPP-300890; FRL-5770-6]
RIN 2070-AD14
Registration Requirements for Antimicrobial Pesticide Products
and Other Pesticide Regulatory Changes
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing to establish procedures for the registration
of antimicrobial products, as well as implement other provisions of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended
by the Food Quality Protection Act. This proposal is required by FIFRA.
In addition to registration procedures for antimicrobial products,
EPA also proposes to establish labeling standards for antimicrobial
public health products, which will ensure that these products are
appropriately labeled for the level of antimicrobial activity they
demonstrate; to modify its notification process for antimicrobial
products to conform to the statutorily prescribed process; and to
exempt certain antimicrobial products from FIFRA regulation.
EPA believes that the new procedures and provisions will streamline
and improve the registration process, increase consistency and
certainty for antimicrobial producers, reduce the timeframes for EPA
decisions on antimicrobial registrations, increase public health
protection by ensuring the continued efficacy of antimicrobial public
health pesticides, and promote international harmonization efforts.
EPA is also proposing to implement a number of general provisions
of FIFRA that are not specific to antimicrobial pesticides. EPA
proposes to interpret the applicability of the new FIFRA definition of
``pesticide'' that excludes liquid chemical sterilants from FIFRA
regulation and includes nitrogen stabilizers, and to describe
requirements pertaining to use dilution labeling. These proposals are
intended to implement new provisions of FIFRA, and to update current
regulations and procedures.
Finally, EPA is proposing technical, conforming and organizational
changes to portions of its regulations on pesticide registration and
labeling for clarity and understanding.
DATES: Comments, identified by the docket control number OPP-300890,
must be received on or before November 16, 1999.
ADDRESSES: Comments may be submitted by regular mail, electronically,
or in person. Please follow the detailed instructions for each method
as provided in Unit I of the SUPPLEMENTARY INFORMATION section of this
notice.
FOR FURTHER INFORMATION CONTACT: Jean M. Frane, Field and External
Affairs Division (7506C), Office of Pesticides Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone
number: 703-305-5944; e-mail address: frane.jean@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Notice Apply to You?
You may be potentially affected by this notice if you are a
producer or registrant of antimicrobial or other pesticide products.
Regulated categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Category Examples NAICS Code
------------------------------------------------------------------------
Producers Pesticide products
32532
Antifoulant paints
32551
Antimicrobial
pesticides 32561
Nitrogen
stabilizer
products 32531
Wood preservatives
32519
------------------------------------------------------------------------
Wholesalers Pesticide products
42291
Antimicrobial
products 42269
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed in the ``FOR FURTHER INFORMATION
CONTACT'' section.
B. How Can I Get Additional Information or Copies of Support Documents?
1. Electronically. You may obtain electronic copies of this
document and various support documents from the EPA Home page at the
Federal Register Environmental Documents entry for this document under
``Laws and Regulations'' (http://www.epa.gov/fedrgstr/).
2. In person. The Agency has established an official record for
this action under docket control number OPP-300890. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed
as confidential business information (CBI). This official record
includes the documents that are physically located in the docket, as
well as the documents that are referenced in those documents. The
public version of the official record does not include any information
claimed as CBI. The public version of the official record, which
includes printed, paper versions of any electronic comments submitted
during an applicable comment period, is available for inspection in the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.
C. How and to Whom Do I Submit Comments?
You may submit comments by mail, in person, or electronically. To
ensure proper receipt by EPA, it is imperative that you identify docket
control number OPP-300890 in the subject line on the first page of your
response.
1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460.
2. In person or by courier. Deliver comments to: Public Information
and Records Integrity Branch in Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. The Docket Control Office
telephone number is (703) 305-5805.
3. Electronically. You may submit your comments electronically by
e-mail to: opp-docket@epa.gov ,'' or you can submit a computer disk
as described above. Do not submit any information electronically that
you consider to be CBI. Avoid the use of special characters and any
form of encryption. Electronic submissions will be accepted in
Wordperfect 5.1/6.1 or ASCII file format. All comments in electronic
form
[[Page 50673]]
must be identified by docket control number OPP-300890. Electronic
comments may also be filed online at many Federal Depository Libraries.
D. How Should I Handle Information That I Believe Is Confidential?
You may claim information that you submit in response to this
document as confidential by marking any part or all of that information
as CBI. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2. A copy of the
comment that does not contain CBI must be submitted for inclusion in
the public record. Information not marked confidential will be included
in the public docket by EPA without prior notice.
E. We Invite Your Comments
EPA invites you to provide your views on this proposal, approaches
we have not considered, the potential impacts of the various options
(including possible unintended consequences), and any data or
information that you would like the Agency to consider. You may find
the following suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide solid technical information and/or data to support your
views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate.
5. Indicate what you support, as well as what you disagree with.
6. Provide specific examples to illustrate your concerns.
7. Make sure to submit your comments by the deadline in this
proposed rule.
8. At the beginning of your comments (e.g., as part of the
``Subject'' heading), be sure to properly identify the document you are
commenting on. You can do this by providing the docket control number
assigned to the proposed rule, along with the name, date, and Federal
Register citation.
II. Organization of Preamble
This preamble is organized according to the outline in this unit.
I. General Information
II. Organization of Preamble
III. Authority
A. The Federal Insecticide, Fungicide, and Rodenticide Act
B. The Food Quality Protection Act
C. The Antimicrobial Regulation Technical Corrections Act
IV. Antimicrobial Provisions Addressed in this Proposal
A. Overview
B. Defining Classes of Antimicrobial Use Patterns
C. Defining Types of Application Reviews
D. Conforming Degree of Review to Risks and Benefits
E. Ensuring Efficacy
F. Implementing Deadlines for Process Management
G. Certification Process for Regulatory Actions
H. Certification of Laboratories
I. Notification Processes
J. Revised Procedures for Application Review
K. Allocation of Resources
L. Completeness of Applications
V. Other Statutory Provisions Addressed in this Proposal
A. Changes to the Definition of ``Pesticide''
B. Notification Procedures
C. Use Dilution Labeling
VI. What is an Antimicrobial Pesticide?
A. General Definition
B. Food Use Exclusion
C. Other Specific Exclusions
D. Products Included
VII. Current Registration Procedures for Pesticides
A. Overview of Procedures
B. Volume of Work
C. Review Times
D. Non-regulatory Guidance Documents
VIII. Proposed Antimicrobial Procedures
A. Organization of Proposed Subpart W and Relationship to
Current Regulations
B. Applicability of Subpart W
C. Definitions
D. Types of Applications
E. Consultations During the Application Process
F. Contents of Applications
G. EPA Action on Applications
H. Review Periods
IX. Duration of Registration for Products Bearing Public Health
Claims
A. Statutory Requirements
B. Alternatives Considered
C. Sunset Provision
X. General Conditions of Registration
XI. EPA/FDA Jurisdiction over Antimicrobial Products Used in or on
Food
A. Background
B. FDA Regains FFDCA Jurisdiction
C. EPA Retains FIFRA Jurisdiction
XII. Efficacy Performance and Labeling Standards for Antimicrobial
Products
A. Need for Rule
B. 1984 Proposal
C. Current Proposal
XIII. Other Labeling Revisions
A. Use Dilution Labeling
B. Reorganization of Labeling Regulations
C. Updated Toxicity Categories
XIV. Chemical Sterilants
A. Liquid Chemical Sterilants Excluded by Statute
B. Non-liquid Chemical Sterilants Exempted by Regulation
C. Antimicrobial Products Neither Excluded nor Exempted
D. Ethylene Oxide
XV. Nitrogen Stabilizers
A. Nitrogen Stabilizers are Regulated as Pesticides
B. What is a Nitrogen Stabilizer?
XVI. Notification of Registration Changes
A. FQPA Modifications
B. Comparison of Current and New Procedures for Antimicrobial
Products
XVII. Conforming and Organizational Changes
A. Changes in Definitions
B. Exclusions and Exemptions Under FIFRA
XVIII. Consultations During the Development of this Proposal
A. Stakeholder Meetings
B. Workshops
C. Food and Drug Administration
D. Canada
XIX. Table of Affected Sections
XX. Statutory Review Requirements
XXI. Regulatory Assessment Requirements
III. Authority
A. The Federal Insecticide, Fungicide, and Rodenticide Act
This proposal is issued under the authority of FIFRA sections 3 and
25, 7 U.S.C. 136a and 136w. Under FIFRA, a pesticide product may not be
distributed or sold in the United States unless it is registered with
the EPA. Registration is a licensing process in which EPA evaluates
each proposed product, its uses, and its labeling to determine whether
it meets the standard for registration in FIFRA section 3(c)(5). That
standard states that, for a registration to be approved, EPA must
determine that the pesticide product, when used in accordance with its
intended uses and with widespread and commonly recognized practice,
will not cause unreasonable adverse effects on the environment. The
registration standard is a risk/benefit standard, which must take into
account the economic, social and environmental costs and benefits of
use.
B. The Food Quality Protection Act
On August 3, 1996, Congress enacted the Food Quality Protection Act
(FQPA), modifying FIFRA and the Federal Food, Drug and Cosmetic Act
(FFDCA). Most of its provisions were effective immediately, although
some require implementing regulations. Units IV. and V. discuss the
statutory provisions of FIFRA as amended by FQPA that this proposal
would implement.
C. The Antimicrobial Regulation Technical Corrections Act
On October 30, 1998, Congress enacted the Antimicrobial Regulation
Technical Corrections Act (ARTCA), which modified the Federal Food,
Drug, and Cosmetic Act (FFDCA) to effectively transfer authority over a
number of pesticide residues to FDA. Regulatory authority over these
residues had originally been transferred to EPA by FQPA. Unit XI.
discusses the
[[Page 50674]]
consequences of this statute and how EPA and FDA jurisdiction over
antimicrobial pesticide residues in food has been allocated by ARTCA.
IV. Antimicrobial Provisions Addressed in this Proposal
A. Overview
The FQPA amendments to FIFRA focus attention on antimicrobial
pesticides specifically, and the procedural framework under which the
Agency reviews and approves applications for registration and amendment
of antimicrobial pesticides. This unit discusses the new statutory
provisions for antimicrobial products and how this proposal satisfies
each statutory requirement.
1. Under FIFRA section 3(h)(1), EPA must evaluate its registration
process to identify improvements and reforms that would reduce
historical review times for antimicrobial applications.
2. FIFRA section 3(h)(2) defines the goals for review that process
improvements should be designed to achieve, expressed as review period
reduction goals for various types of applications.
3. Under FIFRA section 3(h)(3)(A), EPA must propose regulations
that address a number of application process elements, with the goal of
implementing specified process management improvements and meeting
section 3(h)(2) goals. EPA is today proposing these regulations. Unit
VIII. discusses each of following statutorily mandated elements, and
briefly describes how today's proposal addresses those requirements:
a. Defining the classes of antimicrobial use patterns.
b. Defining types of application review.
c. Conforming reviews to risks and benefits.
d. Ensuring efficacy.
e. Meeting review time goals.
4. Under FIFRA section 3(h)(3)(B), EPA must in its final rule
consider specified types of application and process improvements that
would contribute to meeting the review time goals or otherwise simplify
the application process, including:
a. Certification mechanisms for applications.
b. Certification of laboratories.
c. Expanded use of notification and non-notification procedures.
d. Clarification of completeness criteria for applications.
e. Revised procedures for application review.
f. Allocation of resources.
In order to consider these topics for inclusion in the final rule,
EPA must offer proposals or options for notice and comment today that
could be incorporated into a final rule. EPA is today proposing
regulations addressing expanded use of notification procedures (see
Unit XVI.) and completeness criteria (See Unit VIII.F.). EPA has
considered certification mechanisms for applicants, and, as discussed
in Unit IV.G., may establish such a mechanism administratively. EPA has
also considered the possibility of laboratory certification programs,
but is not making a specific proposal at this time.
Under FIFRA section 3(h)(3)(B), a final regulation must be
promulgated no later than 240 days after the end of the comment period
for those portions of this proposal required by FIFRA section 3(h).
B. Defining Classes of Antimicrobial Use Patterns
FIFRA section 3(h)(3)(A)(ii)(I) requires that EPA ``define the
various classes of antimicrobial use patterns.'' EPA has developed a
comprehensive list of antimicrobial use patterns in conjunction with
its upcoming part 158 proposal on antimicrobial data requirements. That
proposal would establish a set of data requirements that apply solely
to antimicrobial pesticides. EPA has developed an appendix of all
current antimicrobial use patterns, divided into 12 use categories
having common exposures or other similarities. The proposal meshes with
the statutory mandate to identify classes of antimicrobial use patterns
by defining, for each use category, the data requirements that apply.
Unit VIII.D. includes a list of the use categories. A copy of the full
draft Use Appendix is in the docket for this proposal. EPA intends its
proposal of part 158 data requirements to satisfy the statutory
requirement to define classes of antimicrobial use patterns.
C. Defining Types of Application Reviews
FIFRA section 3(h)(3)(A)(ii)(II) requires that EPA ``differentiate
the types of review undertaken for antimicrobial pesticides.'' Since
the primary purpose of differentiating types of review is to ensure
that review time goals are met, EPA views the statutory requirement as
equivalent to defining the types of applications associated with the
review periods in section 3(h)(2). Proposed Sec. 152.445 addresses the
various application types, and describes the general criteria EPA uses
to characterize an application. EPA intends that this section will
satisfy the statutory requirement to differentiate types of reviews,
and also in part will satisfy the requirement for setting out differing
levels of data requirements for various classes of products under FIFRA
section 3(h)(3)(A)(ii)(I).
D. Conforming Degree of Review to Risks and Benefits
FIFRA section 3(h)(3)(A)(ii)(III) requires that EPA ``conform the
degree and type of review to the risks and benefits presented by
antimicrobial pesticides and the function of review under this Act,
considering the use patterns of the product, toxicity, expected
exposure and product type.''
The function of review under FIFRA for any pesticide product, not
just an antimicrobial pesticide, is grounded in the registration
standards of FIFRA section 3(c)(5). As such, EPA review must:
1. Assess the risks and benefits of the pesticide and its use,
relevant to the determination of unreasonable adverse effects. In the
case of a public health antimicrobial pesticide, a determination that
the product is efficacious when used as directed is central to a
benefits assessment.
2. Determine the adequacy of the pesticide labeling in directing
the pesticide user as to intended and safe use of the pesticide,
thereby minimizing potential adverse effects to the user and the
environment.
EPA believes that its proposed part 158 regulation defining use
categories and data requirements clearly acknowledges that different
use patterns have different exposure patterns and risks. The data
requirements for each use category are commensurate with the potential
exposures and risks associated with that use pattern, and in some cases
are tiered so that higher exposures or higher risks require a second
level of data. The amount and types of data required in and of
themselves dictate a review process that is more detailed, requiring a
more complex assessment for these potentially higher exposures or
higher toxicity. Therefore, in issuing part 158, EPA intends that the
mandate to conform the degree and type of review to risks and benefits
of use will be satisfied.
E. Ensuring Efficacy
FIFRA section 3(c)(5) has required since 1972 that the composition
of a pesticide be such as to warrant the claims made for it, i.e., that
a product work as claimed. Moreover, the registrant must ensure that
the pesticide product continues to meet that efficacy standard as long
as the product is registered. What has changed over time is the manner
in which EPA is assured of product efficacy. Until 1980, EPA
[[Page 50675]]
reviewed efficacy data for every pesticide product prior to
registration, and thus could assure that, at least at the time of
registration, each product would perform as intended. In 1980, EPA
determined that, for pesticides of economic or aesthetic significance,
the marketplace can be relied upon to weed out inefficacious products.
EPA reasoned that because users can determine for themselves whether a
product works, and are motivated by economic reasons to ensure that
they are using the most efficacious products, less efficacious products
would not survive in a highly competitive marketplace. Accordingly, EPA
no longer routinely reviews efficacy data prior to registration for
most insecticides, fungicides, herbicides, and non-public health
antimicrobial pesticides. Registrants must maintain data demonstrating
efficacy in their files, and submit it to the Agency upon request.
EPA recognized, however, that it could not reduce its efficacy
oversight of public health products and still be assured of product
efficacy. The failure of public health products to work as intended
could have consequences far beyond those of mere economic or aesthetic
significance. Consumers and public health officials must have assurance
that a product will work against pests that pose public health threats.
Many public health products are antimicrobial pesticides registered to
control bacteria, viruses, protozoa, and other microorganisms
pathogenic to man (others are insecticides and rodenticides controlling
pests that are vectors of disease in man). Unlike insects or weeds,
microbial pests cannot be seen, and users cannot determine by
observation whether the product actually performs as claimed.
Therefore, EPA cannot rely upon the users or marketplace forces to
ensure product efficacy. Accordingly, EPA has continued to review
efficacy data for public health products prior to registration.
Subdivision G of the Pesticide Assessment Guidelines describes the
efficacy tests required, and the Labeling Guidelines for Pesticide Use
Directions - Antimicrobial Products (Subdivision H) contain the
performance standards that EPA uses to ensure that antimicrobial
products achieve an acceptable level of efficacy for the claims made.
The Pesticide Assessment Guidelines are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA
22161.
FIFRA section 3(h)(3)(A)(ii)(IV) requires EPA to ``ensure that the
registration process is sufficient to maintain antimicrobial pesticide
efficacy and that antimicrobial pesticide products continue to meet
product performance standards and effectiveness levels for each type of
label claim made.'' At first glance, this language may appear merely to
reinforce the existing efficacy standard of FIFRA section 3(c)(5) that,
to be registered, a product must be efficacious. On closer reading,
however, it is clear that the language carries a broader mandate making
explicit the role of the registration process in ensuring continued
efficacy after registration.
EPA has relied on post-registration mechanisms, including
enforcement monitoring, good laboratory practice monitoring and data
audits, testing by EPA and States as co-regulators, registrant
reporting under FIFRA section 6(a)(2), and user complaints to target
inefficacious products in the marketplace. In recent years, enforcement
actions have found a number of incidents of product failure which have
called into question the ability or willingness of producers to ensure
and maintain the efficacy of their products after registration. As a
result, EPA has since 1990 undertaken a systematic testing program for
antimicrobial pesticides. In cooperation with FDA, EPA has tested
sterilant products and has brought a number of enforcement and
regulatory actions against products found to be inefficacious. EPA is
now testing tuberculocides and hospital disinfectants.
After a product has been identified as failing in efficacy, EPA may
use enforcement measures (such as Stop Sale, Use and Removal Orders) to
correct problems. EPA may also use remedies such as cancellation of
registration under FIFRA section 6 to remove inefficacious products
from the marketplace. EPA has found that post-registration reporting,
monitoring, testing and cancellation processes can be cumbersome and
time-consuming. In some cases, products that EPA has found to be
inefficacious have taken years for resolution through the hearing and
appeals processes available to registrants.
EPA agrees wholeheartedly that measures to strengthen the Agency's
oversight of antimicrobial efficacy as part of registration are
desirable. Today's proposal contains two specific provisions to improve
and strengthen EPA's regulatory oversight of the efficacy of public
health antimicrobial pesticides:
1. EPA proposes to incorporate into its regulations, as subpart W
of part 156, the efficacy performance standards for public health
products that are now contained only in its Labeling Guidelines. Unit
XII. further discusses efficacy performance standards for public health
antimicrobial pesticides.
2. EPA proposes to limit the duration of registrations bearing
public health claims to 5 years. In order to extend the registration
for an additional 5 years, each registrant would have to confirm by
analysis that the product composition was the same as that in Agency
files previously demonstrated to be efficacious, and that the product
continued to meet efficacy standards specified in subpart W for each
public health claim. Unit IX. discusses the 5-year duration provision
in greater detail.
EPA believes that these two regulatory provisions will fulfill the
statutory requirement that EPA ensure continued product efficacy
through the registration process.
F. Implementing Deadlines for Process Management
FIFRA section 3(h)(3)(A)(ii)(V) requires that EPA ``implement
effective and reliable deadlines for process management.'' EPA believes
that the ``deadlines'' referred to are those contained in FIFRA section
3(h)(1), which requires EPA to identify and evaluate reforms to the
antimicrobial registration process; FIFRA section 3(h)(2), which
establishes goals for reduction of review periods for antimicrobial
applications for registration; and FIFRA section 3(h)(3)(D), which
establishes default review periods that apply if EPA fails to issue its
final antimicrobial rule by the statutorily required deadline. As
discussed more fully in Unit VIII.H., EPA is today proposing in
Sec. 152.457 to adopt the ``goal'' review periods rather than the
``default'' review periods.
G. Certification Process for Regulatory Actions
FIFRA section 3(h)(3)(B)(iii)(I) requires that, in issuing final
regulations, EPA must ``consider the establishment of a certification
process for regulatory actions involving risks that can be responsibly
managed, consistent with the degree of risk, in the most cost-efficient
manner.''
Certification statements are currently permitted by
Sec. 152.44(b)(2) for various types of amendments to registration when
directed by EPA. Typically, EPA uses certification to accomplish
specific changes to registration (frequently labeling changes). EPA has
included in this proposal a broader provision that would allow the
Agency to implement self-certification programs as needed in
[[Page 50676]]
the future administratively. Unit VIII.A. discusses further this
provision.
With respect to data certification, EPA has considered two self-
certification programs in the recent past, and has implemented one of
these. PR Notice 98-1, Self-Certification of Product Chemistry Data,
was issued on January 12, 1998. In that notice, EPA describes the types
of product chemistry information (product characteristics) that can be
supplied to the Agency together with a self-certification that the data
were conducted according to EPA Guidelines. Under this program, EPA
would generally review only the summarized results of testing at the
time of application, but could review full study reports if EPA
determines that a complete evaluation of the study is warranted. Review
of the summary results of testing rather than of the complete study
report would decrease the time needed for all applications for
registration of new products and reregistration of existing products.
EPA also considered a similar self-certification procedure for
acute toxicity data, and intends in the future to implement such a
program for antimicrobial products only. EPA originally considered an
acute toxicity data self-certification program because a backlog of
applications requiring acute toxicity data review extended review
periods while applications waited in queue. The certification mechanism
considered would have been available only with respect to a study
indicating that the product should be assigned to Toxicity Category III
or IV. The certification procedure was viewed as a means of reducing
the resources needed for review, and thus making more decisions with
the same level of resources. At the same time, EPA recognized that the
certification procedure could also reduce to some extent the Agency's
confidence in hazard and precautionary statements on labeling. Since
EPA issued its notice for comment, however, the Agency has achieved a
significant reduction in the backlog and consequently in the review
times for applications in the queue. The Agency decided therefore not
to pursue a certification approach for acute toxicity studies at this
time.
Although EPA has decided not to adopt such an approach for
pesticides in general, the Agency has decided to consider a pilot
program that allows applicants for registration of antimicrobial
product to certify the results of an acute toxicity study when the test
data would indicate the product is in Toxicity Category I (the highest
toxicity category). Because such a product would be subject to the most
stringent labeling requiements, applicants would have no incentive to
certify that a product of lower toxicity was in Toxicity Category I.
Moreover, EPA's review of such data would add little value and would
use limited resources. EPA invites comment on this proposed approach to
certification of acute toxicity data, which would be implemented by a
notice to registrants if EPA decides to adopt it.
H. Certification of Laboratories
FIFRA section 3(h)(3)(B)(iii)(II) requires EPA to ``consider the
establishment of a certification process by approved laboratories as an
adjunct to the review process.'' EPA currently has underway a broad
program across the Agency evaluating the feasibility of laboratory
accreditation mechanisms for a variety of program and regulatory needs.
The Office of Pesticide Programs has also been actively working with
outside groups, such as the Chemical Specialties Manufacturers'
Association to further their efforts to develop laboratory
accreditation programs for antimicrobial products. EPA has considered
whether a program could be instituted at this time for antimicrobial
products, and believes that these efforts need further evaluation and
development before being integrated into the Agency's regulatory
programs. EPA intends to continue its cooperative work, and to fold its
efforts into the larger Agency process. Thus, EPA is not today
proposing a specific laboratory accreditation process as part of this
proposed rule.
I. Notification Processes
FIFRA section 3(h)(3)(B)(iii)(III)(aa) requires that, in issuing
final regulations, EPA must use ``expanded use of notification and non-
notification procedures.'' This requirement dovetails neatly with the
statutorily expanded scope of notifications under FIFRA section
3(c)(9). EPA is today proposing to include in new Sec. 152.446 the new
procedures to expand the use of notification as a mechanism for the
label modification as directed by section 3(c)(9).
J. Revised Procedures for Application Review
FIFRA section 3(h)(3)(B)(iii)(III)(bb) requires that, in issuing
final regulations, EPA must use ``revised procedures for application
review.'' As outlined in Unit VII, EPA's current regulations for
registration of pesticide products, including antimicrobial pesticides,
are generally limited to describing the applicant's and Agency's
responsibilities and interactions. The summary description given in
that unit is similar for all pesticides. EPA intends to issue or revise
its current non-regulatory guidance documents that address the
application process in greater detail. To the extent that EPA develops
different procedures for antimicrobial products than for other
products, EPA will make those procedures available via direct notice to
affected registrants, and will make them widely available by all
feasible means, including electronic accessibility.
The Agency has already implemented a number of administrative
reforms to improve the process, including revised procedures for
review. Since FQPA was enacted, the Agency has established a separate
Division solely responsible for antimicrobial products. The new
Antimicrobials Division is charged with all aspects of antimicrobial
regulation, and includes a full complement of scientific personnel in
biology, microbiology, chemistry, toxicology, and other scientific
disciplines, as well as an ombudsman to deal directly with registrant
issues and concerns.
The new Division has focussed initially on meeting the review
period goals established by the statute for all new applications. To
assist this effort, a dedicated Expedited Review Team has been formed
for the purpose of processing notifications and screening and
processing applications that are ``fast-track'' or with review periods
of 90 days or less. By identifying and handling the less complex
actions, this team allows the Division to channel its scientific and
management resources into review of applications that are of higher
priority or that require in-depth review. The Division has added more
Product Managers, so that each Product Manager has a smaller and more
focussed product universe.
The Division has also targeted increased outreach, communication
and information exchange as a high priority. Training materials,
information sheets, operating procedures and science reviews have been
developed or reevaluated for streamlining opportunities.
Additional administrative accomplishments and plans are detailed in
the Agency's first progress report to Congress, Streamlining
Registration of Antimicrobial Pesticides, July 1997. EPA will issue
this report annually as required by section 3(h)(4). Each report will
identify further progress in management and administrative reforms.
K. Allocation of Resources
FIFRA section 3(h)(3)(B)(iii)(III)(cc) requires that, in issuing
final
[[Page 50677]]
regulations, EPA must address ``allocation of appropriate resources to
ensure streamlined management of antimicrobial pesticide
registrations.'' The allocation of resources is not a reform that can
be accomplished by Agency regulations, and EPA is not proposing any
regulations for doing so. Budget and resource allocations are guided by
Executive branch and Congressional priorities and are determined year
by year based on overall needs of the Agency and the pesticide program.
L. Completeness of Applications
FIFRA section 3(h)(3)(B)(iii)(IV) requires that, in issuing final
regulations, EPA must ``clarify criteria for determination of the
completeness of an application.'' EPA is today proposing in Sec. 152.3
a definition of a ``complete application'' for all registration
applications. In addition, specific to antimicrobial products, and
directly responsive to the requirement of FIFRA section 3(h)(3)(B), EPA
is proposing in Sec. 152.450 to describe in detail the contents of an
application, and the criteria that will be used to judge the
completeness of the application as a whole, and of its individual
components. EPA's proposals are discussed further in Unit VIII.F.
V. Other Statutory Provisions Addressed in this Proposal
A. Changes to the Definition of ``Pesticide''
FQPA modified FIFRA section 2(u) to exclude certain liquid chemical
sterilant products from the definition of ``pesticide,'' and to include
certain nitrogen stabilizer products. This provision was effective on
August 3, 1996. In recognition of this provision, EPA is proposing to
add a new Sec. 152.6 entitled ``Substances excluded from regulation by
FIFRA.'' EPA has issued a notice to registrants, entitled ``Liquid
Chemical Sterilant Products'' (PR Notice 98-2; January 15, 1998),
explaining how it will treat liquid chemical sterilants affected by
section 2(u). Units XIV. and XV. discuss chemical sterilants and
nitrogen stabilizers.
B. Notification Procedures
FIFRA section 3(c)(9)(C) now authorizes registrants of
antimicrobial products to make certain defined labeling modifications
by notification to the Agency instead of amendment, and establishes a
procedure for notifications and Agency decisions. This provision was
effective on August 3, 1996, and the new procedures are exclusive to
antimicrobial products. Today's proposal codifies these new
notification procedures. The substance of the expanded notifications
permitted by FIFRA section 3(c)(9) is issued in notices to registrants
(PR Notices), and not in today's proposal. Unit XVI. discusses
antimicrobial notifications.
C. Use Dilution Labeling
FIFRA section 3(c)(9)(D) authorizes registrants to include on their
labeling precautionary statements about the product as diluted for use
(use dilution labeling). This provision was effective on August 3,
1996. EPA proposes to reformat its human hazard labeling requirements
in Sec. 156.10(h) and to incorporate use dilution requirements in
appropriate sections. Unit XIII.A. discusses use dilution labeling.
VI. What is an Antimicrobial Pesticide?
EPA proposes in Sec. 152.3 a definition and interpretation of
antimicrobial pesticide. The proposed definition is paraphrased from
that in section 2(mm) of FIFRA, and interprets the undefined elements.
Because FIFRA section 3(h) directs EPA to develop and implement special
procedures in its regulatory program for antimicrobial pesticides, it
is important that there be a well-defined and commonly understood
universe of products to which the statutory provisions apply. The
practical consequences of being included or excluded as an
``antimicrobial pesticide'' are significant for both pesticide
producers and the Agency. FIFRA section 2(mm) defines the term
``antimicrobial pesticide,'' carefully delineating its boundaries to
mesh with the practical implementation of section 3(h) requirements.
This unit discusses the definition in detail.
A. General Definition
Under FIFRA section 2(mm)(1)(A), an antimicrobial pesticide is
defined as
:(A) [A pesticide that] is intended to:
(i) disinfect, sanitize, reduce or mitigate growth or
development of microbiological organisms; or
(ii) protect inanimate objects, industrial processes or systems,
surfaces, water, or other chemical substances from contamination,
fouling or deterioration caused by bacteria, viruses, fungi,
protozoa, algae, or slime;
With respect to the scope of pests covered by the definition,
paragraph (i) focusses on the intended pesticidal function (disinfect,
sanitize, etc.) against non-specific ``microbiological organisms,''
while paragraph (ii) focusses on non-specific ``protection'' provided
by the pesticide against specified microorganisms (bacteria, viruses,
etc). As a practical matter, EPA believes that the term
``microbiological organisms'' in paragraph (i) should be considered to
include each of the specific types of microorganisms in paragraph
(ii)--bacteria, viruses, fungi, protozoa, and algae. Therefore, EPA
will consider any product intended for use against the microorganisms
specified in paragraph (ii) to be an antimicrobial pesticide (subject
to the exclusions discussed in Unit VI.B. and C.)
Having identified the universe of substances that, based upon the
intended pesticidal purpose, are antimicrobial pesticides, the
definition goes on in paragraphs (1)(B) and (2) to exclude certain
pesticides from the definition of antimicrobial pesticide. These
exclusions may be characterized as use-based, that is, a pesticide is
excluded because of how or where it is used, and not because of the
pests or purpose of use.
B. Food Use Exclusion
FIFRA section 2(mm)(1)(B) excludes from ``antimicrobial pesticide''
those pesticides whose intended antimicrobial use is such that residues
in food requiring regulation under section 408 or 409 of the FFDCA
might result.
(B) [A pesticide that] in the intended use is exempt from, or
otherwise not subject to, a tolerance under section 408 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a and 348) or a
food additive regulation under section 409 of such Act.
In creating this exclusion, Congress recognized that applications
for registration of food uses that require clearance under FFDCA
require extensive data and relatively complex risk assessments that
take longer to review. Moreover, obtaining an FFDCA clearance is a
formal regulatory procedure. As discussed in Unit VIII.H., FIFRA
section 3(h) establishes goals for completion of Agency review of an
application for registration. In EPA's view, Congress recognized the
difficulty of requiring the review timeframes for registration to
encompass the complexities of FFDCA clearance as well. Accordingly, EPA
believes that Congress intended the statutory definition to allow
exclusion of any antimicrobial pesticide that would require the
extensive clearance process of the FFDCA.
The statutory language uses the phrases ``exempt from'' and ``not
subject to'' a clearance under FFDCA. The phrase ``exempt from'' is
clear and has meaning under FFDCA: an exemption from the requirement of
a tolerance is a formal regulatory determination made by EPA.
Exemptions from the requirement of a tolerance are found in 40 CFR part
180.
[[Page 50678]]
The phrase ``not subject to'' is not a formal determination under
FFDCA. Any product that bears a food use is ``subject to'' a tolerance,
that is, a tolerance or other clearance is required, whether that
tolerance has been established or not. EPA believes the statutory
language may be unintentionally broad in not differentiating between
food uses subject to an ``existing'' tolerance and those subject to a
``new'' tolerance. Products and uses subject to an existing tolerance
do not require extensive review; only products subject to a new
tolerance require such review. As written, the definition excludes both
types of antimicrobial pesticides, although the apparent intent is to
exclude only those requiring the lengthy and complicated tolerance-
setting review associated with a new clearance.
In its discretion, EPA proposes to narrow the food use exclusion to
conform to what it believes is the probable intent of Congress. EPA
proposes to exclude from the definition of ``antimicrobial pesticide''
only products bearing one or more uses for which a new clearance is
needed, or an amendment of an existing clearance. EPA proposes to
include in the definition of ``antimicrobial pesticide'' (to exclude
from the exclusion) product/uses ``subject to'' an existing tolerance.
EPA believes that this narrower policy choice, while not required, more
closely reflects the intent to include in the definition of
``antimicrobial pesticide'' products requiring little or no review and
to exclude only products needing the extensive and time-consuming
evaluation associated with the establishment of a new or amended
clearance.
An antimicrobial pesticide, then, is a product bearing only non-
food uses, only food uses covered by an existing clearance under FFDCA,
or some combination of these two.
Given the food use exclusion, it is clear that the status of an
antimicrobial product as an ``antimicrobial pesticide'' within the
meaning of FIFRA section 3(h) is not necessarily a permanent
designation, but may shift according to its intended use. A product
could be included or excluded from the definition if the intended use
changes. The status of a pesticide as an ``antimicrobial pesticide''
becomes pertinent and can only be determined at the time of submission
of an application for Agency decision. At that time, EPA must determine
whether the pesticide application is for an antimicrobial pesticide
within the meaning of the statutory definition.
The prime example of this use-dependent phenomenon is an
application seeking the first food use of an antimicrobial pesticide. A
product that heretofore has been an ``antimicrobial pesticide'' because
it bears only non-food uses or tolerance-covered food uses is no longer
an ``antimicrobial pesticide'' for purposes of EPA review and decision
on that first food use action. Provisions of FIFRA applying only to
``antimicrobial pesticides,'' notably the review periods, would not be
triggered for that action. Once the food use issue is resolved or a
tolerance issued, such that the food use is covered by an existing
tolerance, the product may revert to ``antimicrobial pesticide'' status
for a subsequent action.
C. Other Specific Exclusions
FIFRA section 2(mm)(2) contains further specific exclusions to the
definition. These are intended to clarify that certain types of
products that might be considered ``antimicrobial pesticides'' because
they have a pesticidal effect on the defined types of microorganisms
are nonetheless not to be regulated as antimicrobial pesticides for
purposes of FIFRA section 3(h). It should be noted that certain types
of antimicrobial products are already excluded from regulation under
FIFRA, and therefore from any coverage under this proposed rule.
Products used against microorganisms in or on man or other living
animals are not pesticides because such microorganisms are not
``pests'' under FIFRA section 2(t). Products intended for use against
microorganisms in or on man and animals are regulated solely by FDA.
This is not a change from longstanding FIFRA provisions.
1. Certain wood preservatives and antifouling paints. Any product
that is a wood preservative or antifoulant paint, and that also bears
any claim for a pesticidal activity other than or in addition to those
specified in section 2(mm)(1) is not an antimicrobial pesticide. The
pesticidal activities that generally define an ``antimicrobial
pesticide'' include activity against any microbiological organisms, and
``protection'' against the destructive effects of bacteria, viruses,
fungi, protozoa, algae, and slime.
Both wood preservatives and antifoulant paints (which are used to
protect surfaces in contact with water such as boats) may function to
protect against bacteria, fungi, etc., and thus, without a specific
exclusion, would be deemed to be antimicrobial pesticides. However,
since most wood preservatives also protect against insect damage, and
most antifouling paints also protect against barnacles, the majority of
these products are not likely to be ``antimicrobial pesticides.'' As
discussed in Unit VIII.H., however, some wood preservative products may
be eligible for the review deadlines that apply to antimicrobial
pesticides.
2. Agricultural fungicides. The definition of antimicrobial
pesticide in FIFRA section 2(mm) excludes ``agricultural fungicides.''
Traditionally, the term ``fungus'' in an agricultural context has been
used to mean microorganisms that are pathogenic to plants. Fungi (and
other microorganisms) that are pathogenic to man and animals have
historically been treated separately because of their public health
implications. However, FIFRA section 2(k) defines ``fungus'' broadly to
include a variety of other microorganisms, including rust, smut,
mildew, mold, yeast, and bacteria, without specific reference to
whether the microorganisms are pathogenic to plants or to man and
animals.
EPA intends the term ``agricultural fungicide'' to apply to all
products applied in or on growing crops or to soil (i.e., pre-harvest
application), regardless of the type of pest fungus. Although this
would exclude as ``antimicrobial pesticides'' products applied pre-
harvest against microorganisms that might be pathogenic to man and
animals, EPA is not aware that any pesticides are currently registered
against human and animal pathogens on growing crops. EPA would regulate
such products if the need arose, but they would not be covered by
subpart W.
Under this interpretation, a product intended for post-harvest
application against fungi (including bacteria) would not be an
``agricultural fungicide.'' Significantly, however, such a product
would not necessarily be an ``antimicrobial pesticide'' either, since
the food use exclusion also comes into play. Post-harvest application
of fungicides or antimicrobial products to food or feed crops would run
afoul of the food use exclusion if a new or amended tolerance were
needed to cover pesticide residues. All post-harvest use antimicrobial
products would be subject to subpart W generally; however, not all
would be ``antimicrobial pesticides'' eligible for the review periods
in Sec. 152.457.
3. Aquatic herbicides. Further, the definition of antimicrobial
pesticide excludes aquatic herbicide products. EPA interprets the term
aquatic herbicide to mean pesticides used in or near environmental
bodies of water, such as lakes, streams, or ponds, for the control of
algae or weeds. In contrast, a
[[Page 50679]]
product intended for control of algae in industrial systems or
processes or swimming pools would be considered an antimicrobial
product.
D. Products Included
Finally, section 2(mm)(3) lists a number of products that are
deemed to be antimicrobial pesticides, to ensure that they are not
inadvertently excluded by application of the various exclusions
elsewhere. These include chemical sterilants other than those excluded
under FIFRA section 2(u), other disinfectant products, industrial
microbiocides, and preservatives other than wood preservatives.
VII. Current Registration Procedures for Pesticides
Under FIFRA prior to FQPA, antimicrobial pesticides were not
singled out as a class of pesticide products requiring special
procedural attention. Antimicrobial pesticides were registered using
the same procedures and policies as other pesticide products.
Antifoulants, wood preservatives, and traditional antimicrobial
pesticides were in separate organizational units within EPA.
A. Overview of Procedures
A brief discussion of the registration procedures which have
applied to all products follows. Even though products that are
``antimicrobial pesticides'' will now be subject to a more carefully
drawn and rigorously applied regulatory program, the basic procedures
for registration will continue to apply.
1. A person seeking to register any pesticide product must submit
an application for registration. That application contains information
on the pesticide, copies of the proposed labeling of the product, and
data of various types supporting the registration (such as chemistry,
toxicology, environmental fate, ecological effects). If a food use is
involved, data supporting a clearance for residues in food are also
required, and if the product is of public health significance, efficacy
data must be submitted. Current regulations governing submission of
applications are found in 40 CFR part 152. Data requirements are
described in 40 CFR part 158, and labeling requirements in 40 CFR part
156. The tolerance-setting process is contained in 40 CFR part 180.
2. At EPA, the application is processed in several stages, each of
which evaluates different elements of the application.
a. A ``front end'' process assigns administrative numbers, checks
that basic elements are contained in the application, does a data check
for formatting purposes, and packages the application for review.
b. The application package is directed to the appropriate review
Division and thence to a Product Management (PM) team. Until recently,
two Divisions, the Registration Division and the Biopesticides and
Pollution Prevention Division, were the regulatory Divisions which
reviewed all applications. Antimicrobial pesticide applications were
processed within one branch, and antifoulants and wood preservatives
were located in a different branch, both in the Registration Division.
EPA has established a separate Antimicrobials Division (AD) to help
focus its regulatory management of these products, and antifoulants and
most wood preservatives are also now assigned to this Division.
c. The PM team enters the application into a tracking system,
reviews product labeling and data compensation elements, and determines
whether a scientific review is needed. Every application for new
registration contains some data; the amount and type of data vary
depending on the type of product, its composition and uses. Even
applications without new data often require scientific consultation to
determine the relevance and adequacy of existing data to support the
application.
d. If a scientific review is needed, the PM team sends the
application and data to various scientific reviewers. These reviews are
generally conducted in parallel, although certain assessments must
await the results of other reviews (for example, ecological effects
risk assessment may depend upon the environmental fate profile of the
chemical).
3. Upon completion of all reviews, the PM team consolidates review
recommendations and decisions and determines whether the product can be
registered. If it can, EPA issues a registration, approves the labeling
(often with required modifications), and notifies the applicant. If the
application cannot be approved, the PM notifies the applicant of
deficiencies (data, labeling, administrative) that must be corrected
before proceeding.
Once issued, a registration may be amended by submission of an
application for amendment, which undergoes a similar review process as
outlined above. The significant difference is that many amendments are
administrative, or require no scientific review, and thus entail a less
intensive and time-consuming process. Often amendments can be handled
entirely within a PM team. Some minor modifications to registration can
be accomplished by notification; these are modifications EPA has
determined have no potential for adverse effects. Notifications require
the most minimal review, primarily to ensure compliance with pre-
existing Agency policies or guidance.
B. Volume of Work
Typically, applications for new registration comprise about one-
third of the applications processed by the Agency, but require more
time and resources per application because of the scientific review
involved. Applications for registration of new chemicals and major new
uses require the most resources, but are relatively few in number. For
sheer numbers, the bulk of registration actions are (and likely will
continue to be) amendments to existing registrations that require no
scientific review (so-called ``fast track'' amendments). In FY 1997,
ending September 1997, EPA received a total of 635 actions related to
new applications for registration of pesticides assigned to AD,
including 11 high-resource new chemicals. In addition, there were 1,189
actions related to amendments to existing registrations, including 61
high-resource new uses. The number of ``actions'' includes both the
initial submission of applications for new and amended registration and
resubmissions of information after EPA has notified the applicant that
the application is deficient.
Finally, there were 506 notifications for antimicrobial products,
which under FIFRA section 3(c)(9) must be reviewed and a decision
issued within 30 days of receipt. While these require minimal review,
the large volume coupled with the short review time requires dedicated
resources.
C. Review Times
As with any complex process, the speed at which an application can
be reviewed and a decision made depends upon many things, some within
the control of the Agency, others dependent upon the applicant. FIFRA
prescribes in section 3(c)(3) that an application decision be reached
``as expeditiously as possible.'' Until modified by FQPA, FIFRA
contained only a single statutory decision deadline of 90 days, for so-
called ``fast-track'' applications--those which require no review of
scientific data. This review time is predicated upon receipt of a
``complete'' application. EPA is not required to review and reach a
decision on a fast-track application until it is deemed to be complete
(however, EPA must determine whether such an application
[[Page 50680]]
is complete within 45 days after receipt).
``Fast-track'' deadlines continue to apply to all products,
including antimicrobial pesticides. For antimicrobial pesticides,
however, FIFRA as modified by FQPA imposes additional statutory review
periods.
D. Non-Regulatory Guidance Documents
EPA uses detailed guidance documents to amplify, clarify, and
interpret its regulations in areas such as data and labeling
development and review, process changes, and applicant
responsibilities. EPA has developed a number of documents, which are
available to applicants and registrants, to elaborate on the general
regulations. In particular:
1. A guidance document called simply the ``Blue Book'' provides
specific details about the application process.
2. The Labeling Manual contains guidance for developing labeling
which complies with FIFRA and EPA regulations.
3. The Pesticide Assessment Guidelines describe test methods,
standards, and data reporting requirements used to satisfy data
requirements.
4. Standard Evaluation Procedures describe how EPA will review and
evaluate each type of study submitted in support of registration.
5. EPA uses direct notice to registrants (PR Notices) to inform
them of procedural changes, to clarify and interpret its regulations in
specific circumstances, and for general information purposes.
All of these will continue to apply to antimicrobial pesticides.
Given the special attention FIFRA now focusses on antimicrobial
products, EPA may develop specific guidance documents for antimicrobial
pesticides that would augment or replace existing guidance.
VIII. Proposed Antimicrobial Procedures
This unit discusses in detail the proposed procedural regulations
applicable to antimicrobial products. Proposed changes that apply to
all pesticides are discussed in later units of this preamble.
A. Organization of Proposed Subpart W and Relationship to Current
Regulations
40 CFR part 152 currently contains regulations pertaining to the
registration of pesticide products, including antimicrobial pesticides.
Part 152 contains appropriate definitions and criteria for determining
whether a product is a pesticide that must be registered (subpart A);
exemptions from FIFRA requirements (subpart B); procedures for applying
for registration (subpart C); data compensation procedures (subpart E);
the Agency's review of an application (subpart F); fees for
applications (subpart U) (currently suspended), and criteria and
procedures for classifying a pesticide for restricted use (subpart I).
Most of these provisions are unaffected by changes in FIFRA that target
antimicrobial program reform measures, and will continue to apply to
antimicrobial products as well as other pesticides.
However, FIFRA section 3(h)(3)(A) requires that EPA propose
procedural regulations focussing on antimicrobial pesticides. Because
the statutory reform measures are designed to implement specific goals
directed at antimicrobial products only, EPA proposes to create an
entirely separate subpart devoted to antimicrobial registration
procedures. Proposed new subpart W, entitled ``Registration of
Antimicrobial Products,'' would be a freestanding subpart describing
the application and Agency review procedures mandated by FIFRA section
3(h).
1. Relationship of subpart W to other subparts in part 152. Subpart
W would supersede subpart C of current part 152 for antimicrobial
products only; subpart C would continue to apply to all other products.
In addition, subpart W--for antimicrobial products only--would
supersede certain individual sections of subpart F--Agency Review of
Applications; subpart F would continue to apply to all other products.
Specifically, the following sections would be superseded:
a. Sec. 152.104, Completeness of applications. Completeness of
applications covered by subpart W is contained in Sec. 152.450,
Contents of application.
b. Sec. 152.110, Time for Agency review. Review periods for
applications covered by subpart W are contained in Sec. 152.457, Review
period for applications.
c. Sec. 152.115, Conditions of registration. Conditions of
registration for products covered by subpart W are contained in
Sec. 152.459, Terms and conditions of registration.
d. Sec. 152.117, Notification to applicant. Notification of Agency
decision on an application is contained in Sec. 152.455, Action on
applications.
e. Sec. 152.118, Denial of application. Denial of an application
covered by subpart W is also included in Sec. 152.455, Action on
applications, although the procedures for denial in Sec. 152.118 are
cross-referenced in Sec. 152.455.
As described in Sec. 152.440, all other subparts of part 152 would
continue to apply to products covered by subpart W and other
pesticides. Some minor modifications are proposed to current Sec. 152.1
to properly refer to the antimicrobial subpart. If subpart W and
subpart F conflict for an antimicrobial product or application,
Sec. 152.440 states that subpart W would take precedence.
2. Requirements duplicated in subpart C and subpart W. To be
comprehensive, avoid confusion for users, and avoid cross-referencing
unnecessarily, EPA has repeated in subpart W certain elements of its
current registration regulations from subpart C. In so doing, EPA has
made minor editorial changes not requiring proposal for clarity and
organization. EPA has captured the content of the following sections in
subpart W, and is not requesting comment at this time:
a. Sec. 152.40, Who may apply, which also appears as new
Sec. 152.443.
b. Sec. 152.42, Application for new registration, which has been
incorporated into new Sec. 152.443.
c. Sec. 152.43, Alternate formulations, which also appears as
Sec. 152.444, unchanged.
d. Sec. 152.44, Application for amended registration, which is also
incorporated into new Sec. 152.443.
EPA has incorporated into proposed Sec. 152.443(e) a general
provision for certification programs at the Agency's discretion and
direction. Current regulations in Sec. 152.44(b)(2) allow a
certification submission, in the Agency's discretion, which EPA has
typically used only for Agency-directed actions. EPA has not to date
expanded the certification option to a class of actions submitted on
the applicant's initiative. EPA believes that it may implement
certification programs administratively without regulations.
Nonetheless, in light of the statutory provision requiring
consideration of a certification process, EPA proposes a broader, but
still discretionary, use of certification programs. Under today's
proposal, EPA could identify elements of an application that the Agency
believes are amenable to a certification mechanism. EPA would issue a
guidance document (typically a notice to registrants) that would detail
how a certification program would be used.
B. Applicability of Subpart W
The applicability of subpart W is governed by the statutory mandate
of FIFRA section 3(h) in the first instance. However, because of
differences in scope between the statutory mandate and the Agency's
administration of the antimicrobial program, EPA proposes a
[[Page 50681]]
broader applicability than is provided for by the statute. This unit
explains why certain products would be covered by subpart W and others
would not be.
1. Antimicrobial pesticides and food/feed use antimicrobial
products are covered by subpart W. Although this proposal reflects the
mandate of FIFRA to address ``antimicrobial pesticides,'' EPA has
chosen to cover a broader range of antimicrobial products than
mandated. It makes sense for these procedural regulations to mesh as
closely as possible with the Agency's organization and administration
of the antimicrobial program, so as not to cause confusion either
within the regulated community or within EPA itself. EPA has created an
Antimicrobial Division within the Office of Pesticide Programs, whose
responsibilities extend to all antimicrobial products, not just those
defined as ``antimicrobial pesticides.''
Accordingly, EPA proposes that subpart W would apply to both
``antimicrobial pesticides,'' as defined by FIFRA section 2(mm) and
antimicrobial products that are food/feed use pesticides, but are not
defined as ``antimicrobial pesticides'' by FIFRA section 2(mm).
Virtually all products in these two categories are processed within the
Antimicrobial Division. The procedures and requirements of subpart W
would be applied equally to these two categories of products (with the
exception of review periods).
2. Wood preservatives and antifouling products are not covered by
subpart W. This subpart would not apply to any product that is neither
an ``antimicrobial pesticide'' as defined by FIFRA nor a food/feed use
antimicrobial product. Inclusion in this subpart would complicate the
registration process for products not processed in the Antimicrobials
Division, which are subject to the registration procedures of subpart
C.
The status of wood preservatives and antifoulant paints is
complicated under FIFRA. FIFRA is very specific in defining certain
types of products as antimicrobial pesticides and excluding other,
similar products, depending upon the type of claims made for the
product. A wood preservative or antifoulant paint that makes only an
antimicrobial pesticidal claim is an ``antimicrobial pesticide'' and
would be covered by subpart W as an antimicrobial pesticide. By
contrast, any multi-claim wood preservative or antifoulant paint is not
an ``antimicrobial pesticide'' and would not be covered by subpart W.
As a practical matter, because most antifoulant paints assert non-
antimicrobial barnacle claims, they would not be covered by subpart W.
Likewise, many wood preservatives make insecticidal or fungicidal
claims and would not be covered by subpart W.
Under FIFRA section 3(h)(3)(E), certain wood preservative products
that would not be covered by subpart W may nonetheless be eligible for
the same review periods as antimicrobial pesticides that are covered by
subpart W (see Unit VIII.H. for a full discussion of this provision).
EPA's responsibility for wood preservative products that qualify under
section 3(h)(3)(E) is fulfilled by ensuring that the statutory review
period is met. EPA need not, and does not propose to, make subpart W
apply to these products merely to implement the statutory review
periods.
Because the status of wood preservatives and antifoulant paints is
complex, EPA is providing in Table 1 below a summary of the status of
these products. The table breaks down wood preservatives and
antifoulant paints by type of claim (or combination of claims). Column
1 of the table lists the claim or combination of claims possible;
Columns 2, 3, and 4 answer the questions posed at the top of each
column.
Table 1.--Status of Wood Preservatives and Antifoulant Paints
----------------------------------------------------------------------------------------------------------------
Is this product
Is this product an Will this product be eligible for
``antimicrobial subject to this statutorily-required
pesticide''? proposal? review periods?
----------------------------------------------------------------------------------------------------------------
Wood Preservatives
Insecticide claims only No No No
----------------------------------------------------------------------------------------------------------------
Fungicide claims only No No No
----------------------------------------------------------------------------------------------------------------
Antimicrobial claims only Yes Yes Yes
----------------------------------------------------------------------------------------------------------------
Fungicide and insecticide claims No No No
----------------------------------------------------------------------------------------------------------------
Antimicrobial and insecticide claims No No Yes
----------------------------------------------------------------------------------------------------------------
Antimicrobial and fungicide claims No No Yes
----------------------------------------------------------------------------------------------------------------
Antimicrobial, insecticide and No No Yes
fungicide claims
----------------------------------------------------------------------------------------------------------------
Antifoulant Paints
Insecticide claims (barnacles) only No No No
----------------------------------------------------------------------------------------------------------------
Antimicrobial claims only Yes Yes Yes
----------------------------------------------------------------------------------------------------------------
Antimicrobial and insecticide claims No No No
----------------------------------------------------------------------------------------------------------------
3. Applicability is not dependent on where a product application is
processed. EPA has chosen to extend the proposal to food/feed use
antimicrobials for practical organizational reasons. However, EPA
emphasizes that where a product application is reviewed does not in any
way determine whether subpart W applies. For example, the Antimicrobial
Division currently reviews most antifoulant products, that for the most
part are not covered by subpart W. The Antimicrobial Division also
reviews those wood preservatives that do not make insecticidal claims,
some of which are covered by subpart W. This allocation of products may
change based upon workload and resource needs.
EPA may, in its discretion and for its convenience, choose to treat
products that are not covered by subpart W as if
[[Page 50682]]
they were covered. For example, EPA currently reviews applications for
non-covered products within the review periods of Sec. 152.457, but,
except for the narrow class of wood preservatives discussed above, the
Agency is not required to do so, and would not be subject to any
consequences if it failed to meet a review period.
C. Definitions
Section 152.442 contains definitions that apply to subpart W.
Relatively few definitions are needed here, since most terms are
defined elsewhere, either in FIFRA itself or in part 152. Terms
pertaining to antimicrobial levels of activity (e.g., sterilant,
disinfectant) are defined in subpart W of part 156, because they are
used in conjunction with labeling and not with registration procedures.
Comments are solicited on any additional terms that should be defined
in subpart W to inform or clarify the subpart.
Proposed Sec. 152.442 defines the following terms:
1. The term ``clearance'' is proposed to refer to all types of
clearances required under a regulatory authority other than FIFRA
before a product may be marketed. The term encompasses food tolerances,
exemptions and food additive regulations under FFDCA section 408 and
409, and FDA clearances for medical devices under FFDCA section 510.
2. The term ``complete application'' is the general definition
describing an application that may be placed into formal review. A
complete application is one that contains all elements described by
Sec. 152.450, but not necessarily all information required for
approving a registration or amendment.
3. The terms ``major new use,'' ``substantive amendment,'' and
``minor amendment'' are proposed as concise terms for application types
defined in rather longer phrases in the statute.
D. Types of Applications
1. What the statute requires. FIFRA section 3(h)(2) establishes
review period goals for antimicrobial applications, shown in Table 2
below, and requires in section 3(h)(3) that EPA differentiate in its
regulations the types of review undertaken for antimicrobial
pesticides. As discussed in Unit IV.C., EPA intends that defining these
application types in this proposal, coupled with EPA's part 158
proposal, will serve to adequately differentiate the types of review
undertaken by the Agency. EPA proposes in Sec. 152.445 to define
application types that correspond to the statutory review period goals
prescribed in the statute. The categories EPA proposes are discussed in
this unit.
Table 2.--Statutory Application Categories and Review Periods
------------------------------------------------------------------------
Review period goal
Description of application type ---------------------------------------
Days Months
------------------------------------------------------------------------
Product containing a new active 540 18
ingredient
------------------------------------------------------------------------
Product that is identical or 90 3
substantially similar (to
another registered product)
------------------------------------------------------------------------
Other new product 120 4
------------------------------------------------------------------------
A new antimicrobial use of a 270 9
registered active ingredient
(either a new registration or
an amendment)
------------------------------------------------------------------------
Other amendment that does not 90 3
require scientific review of
data
------------------------------------------------------------------------
Other amendment that requires 90 - 180 3 - 6
scientific review of data
------------------------------------------------------------------------
2. Applications requiring FFDCA clearance. The review periods for
which application types must be described apply only to antimicrobial
pesticides as defined in FIFRA section 2(mm). That definition excludes
food/feed use products that require a clearance under FFDCA. Before
assigning an application to a category having a review period, EPA must
first exclude any application for a food/feed use that requires a new
or revised clearance under FFDCA.
All other antimicrobial pesticide applications fall into one of the
categories, described in proposed Sec. 152.445(b) for new registrations
and proposed 152.445(c) for amendments to existing products.
3. Current application categories. Currently, EPA does not define
types of applications for registration by regulation, but has a
detailed tracking system (the Pesticide Regulatory Action Tracking
System or PRATS) for actions of all types flowing through the pesticide
review process. The system works by assigning action codes to each type
of action for purposes of PRATS tracking, reporting and process
management; the action code definitions are detailed and do not
correlate exactly with the six described in the statute. The PRATS
system describes application types and assigns target review periods
based on features that are not addressed by the general descriptions in
the statute, including:
a. The applicant's method of support for the application
(eligibility for the formulator's exemption, for example).
b. The amounts and types of data that require scientific review
(product chemistry or confirmatory efficacy data, for example, require
minimal review, while toxicology studies require considerable review
time).
c. In the case of amendments, what aspect of the registration is
being amended (composition, labeling).
d. Whether the application is an initial submission or a
resubmission following a rejection of an initial application.
Moreover, combinations of registration actions (for example, a
change in composition and labeling simultaneously, each with supporting
data requirements) complicate EPA's task of describing a categorization
scheme in simple terms.
It would be costly and inefficient for EPA to develop and manage
separate tracking systems for antimicrobial decisions and other
registration decisions. Nor does it make sense to do so. If EPA is to
successfully manage the review process and track review periods for
antimicrobial applications, it must use its existing tracking system.
Accordingly, EPA's approach to defining types of antimicrobial
applications was to crosswalk the types of applications defined by the
statute with the descriptors used in PRATS.
[[Page 50683]]
EPA first sorted the categories of actions in PRATS and identified
those that should be included in one of the six statutory categories.
EPA then fleshed out the statutory descriptions using the greater
detail of PRATS action code descriptions for purposes of this proposal.
The results of this approach are presented in proposed Sec. 152.445.
4. Terms defined for this proposal. EPA proposes to define more
concise terms than the statutory ones for the purposes of this proposed
rule. EPA proposes the following terms: (1) The term ``major new use''
for the statutory term ``new antimicrobial use of a registered active
ingredient''; (2) the term ``substantive amendment'' for the statutory
term ``amendment to an antimicrobial registration that requires
sceintific review of data''; and (3) the term ``minor amendment'' for
the statutory term ``amendment to an antimicrobial product that does
not require scientific review of data.''
5. Single category. Because each antimicrobial pesticide
application type will have a prescribed review period under FIFRA, and
EPA's failure to issue a decision within that review period will be
judicially reviewable, each application must be assigned to a single
application category. Ideally, the applicant and EPA would have a
common understanding of the designation of an application to avoid
disputes over the review period. In all situations, the application
categories in proposed Sec. 152.445 are discrete, that is, there is
only one possible application type that logically should apply. An
application either is for a new registration or is an amendment to an
existing registration. Beyond that broad division, the categories may
be less well understood and subject to disagreement. Under proposed
Sec. 152.445(a), EPA would determine the appropriate category.
There is one situation in which the statutorily designated review
period cuts across the application types as defined in the proposal.
The Act sets a review period of 270 days for a ``new antimicrobial use
of a registered active ingredient'' or ``major new use.'' Proposed
Sec. 152.445 defines application types in the first instance according
to whether they are submitted to EPA as applications for new
registration or amended registration. In the construct of the proposal,
therefore, an application for a ``major new use'' may be either an
application for new registration that includes a major new use, or an
application for amended registration to add a major new use.
Accordingly, both Sec. 152.445(b) and (c) include a separate category
for ``major new use. In both cases, the review period would be 270
days.
6. Applications for new registration--a. A product containing a new
active ingredient. Products containing new active ingredients are a
well-understood category. An application that proposes the registration
of an active ingredient that has never before been registered falls
into this category. A product containing a new active ingredient
typically requires review of considerably more data than one containing
already registered active ingredients.
b. A product bearing a major new use. This category consists of an
application for new registration of a product bearing a major new use.
A major new use is any use that is not registered for one or more of
the active ingredients in a product. Typically a major new use would
involve a significantly different pattern of use that changes or
increases the exposures to the active ingredient, such that substantial
amounts of new data are required to evaluate the different or
incremental risks presented. This definition is comparable to that in
Sec. 152.3 for ``new use'' for non-antimicrobial products.
EPA intends in its part 158 proposal to categorize all
antimicrobial uses into one of the following 12 use categories. All
currently registered antimicrobial use patterns are included in one of
these larger use classifications for data requirement purposes, but EPA
has not to date classified the existing use patterns in this organized
fashion.
Agricultural premises and equipment.
Food handling/storage establishments premises and
equipment.
Commercial, institutional, and industrial premises and
equipment.
Residential and public access premises.
Medical premises and equipment.
Human drinking water systems.
Materials preservatives.
Industrial processes and water systems.
Antifouling coatings.
Wood preservatives.
Swimming pools.
Aquatic areas.
Some categories would be further divided into subcategories.
Subcategories would generally be defined on the basis of similar
exposures and data requirements. Examples of significant use/exposure
differentials among use categories and subcategories are food/non-food
use and indoor/outdoor use or exposure.
Using these categories and subcategories of antimicrobial use
patterns, EPA would regard as a major new use of an antimicrobial
active ingredient any use in a different use category or subcategory
from currently registered uses for that active ingredient. As an
example, an active ingredient is registered with uses in the category
of ``Materials Preservatives'' and subcategory ``Indoor non-food
uses.'' If a registrant proposed a new use either in that same category
for an ``Indoor food use'' (a different subcategory), or in the
different category of ``Residential and Public Access Premises,'' that
application would be a major new use of that active ingredient.
c. A product that is identical to an existing product. For clarity,
this proposal separates ``identical'' and ``substantially similar''
products into two categories, even though they have the same review
period. Applications for end use products of these types are generally
indistinguishable from the so-called ``fast-track'' applications of
FIFRA section 3(c)(3).
Identical products are those that have an identical composition to
another registered product and bear identical use patterns. Both active
and inert ingredients must be identical and in exactly the same
proportion as the existing product. In the universe of antimicrobial
products, ``identical'' products include products that are formulated
by one company and simply repackaged by another company. These so-
called ``repacks'' must be separately registered by the repackager.
Identical products also include those that are actually formulated by a
second producer based upon specifications provided by another
registrant. The significant difference between these two types of
identical products is that ``repacks'' require virtually no data for
registration, while those that are produced separately require certain
minimal ``bridging'' data to ensure that they are actually identical in
composition and efficacy.
Identical use patterns mean that the label does not deviate in
terms of organisms controlled, use sites, or directions for use. An
applicant's product may have fewer (but identical) claims than another
registered product and still be an ``identical'' product, but may not
have different or expanded claims.
d. A product that is substantially similar to an existing product.
Substantially similar products are those that are permitted to have
minor differences in three areas--composition, use pattern, or method
of data support--from another registered product. When evaluated
against another identified registered product, a ``substantially
[[Page 50684]]
similar'' product must have the same active ingredients as the claimed
similar product, in substantially the same proportion. The inert
ingredients must also be substantially similar in chemical composition
and functionality to the claimed similar product. For example,
emulsifiers, fillers, solvents, propellants, etc., in the applicant's
product must have similar counterparts in the cited registered product
so EPA can reasonably conclude that both formulated products will have
essentially the same chemical and physical characteristics and toxicity
profile. Because substantial similarity may depend on the
characteristics of the individual products or the active and inert
ingredients, decisions on similarity would be made on a case-by-case
basis.
Substantially similar use means that the product bears a use
pattern similar to the claimed product. Again, fewer use patterns do
not make the product dissimilar, but adding or changing use patterns
would exclude the applicant's product from treatment as a substantially
similar product. A use pattern is a claim for control of a specified
organism on a specified site under specified conditions of use. With
respect to public health products, for which efficacy considerations
are paramount, use sites must be carefully considered in relation to
the pest organism, and small formulation changes or variations in use
directions can mean the difference between an efficacious product and a
non-efficacious product. For this reason, ``substantially similar'' use
patterns for public health products would be limited to identical
organisms on both products. For non-public health products,
substantially similar use patterns could involve organisms that are
similar but not identical.
A similar method of data support means that the applicant is using
methods of data support that do not require EPA to evaluate data (other
than product chemistry data) to review the application. As a practical
matter, this means that the applicant is either citing all required
studies or requesting a waiver of required studies. Many antimicrobial
products must be supported by efficacy data of some sort. Such products
are not substantially similar even if they are similar in composition
and use pattern to another product, because the submitted efficacy data
must be reviewed by EPA. Such products would be considered ``other''
products.
e. ``Other'' products. All applications for new registration other
than new chemicals, identical or substantially similar products, or
those bearing a major new use, would be assigned to the ``other''
category. These are products which have significant differences in
composition, uses, method of data support or labeling. Proposed
Sec. 152.445(b)(5) provides examples of applications that would be
categorized as ``other'' new applications, but is not comprehensive or
explicit, since it is essentially a default category of application. If
a new application cannot readily be categorized either as a ``new
active ingredient'' or as an ``identical'' or ``substantially similar''
application, it would routinely be placed in this category.
7. Applications for amendment. Applications for amendment to an
existing registration are categorized in much the same fashion as new
applications, that is, by defining the ends of the review spectrum, and
placing all amendments not clearly delineated into a middle category.
EPA therefore defines in this proposal three categories of amendments.
a. Amendment to add a major new use. As noted earlier, a major new
use may be presented to EPA in the form of a new registration or an
amendment. This category is for amendments to add a major new use to an
existing registration (as opposed to a new registration that bears a
major new use). ``Major new use'' would be the same as described
earlier.
b. Minor amendment. At the other end of the amendment spectrum, EPA
proposes an application category termed ``minor amendment.'' This
category is intended to parallel the ``identical or substantially
similar'' category for new applications, and is also identical to the
statutorily-defined ``fast-track'' provision of FIFRA section 3(c)(3).
In no case would a minor amendment require the review of any data. The
examples in proposed Sec. 152.445(c)(3) list minor amendments not in
terms of the actual registration changes that might be proposed, but in
terms of the nature of the evaluation that EPA must do. EPA does not
believe that this proposal can, or needs to, describe all the possible
types of ``minor amendments.''
The following are some characteristics of a minor amendment:
The evaluation can be conducted entirely within a Product
Manager team, without any scientific consultation.
The decision relies only on non-technical, non-scientific
information readily at hand.
The decision requires only regulatory or administrative
judgments, not scientific ones.
The decision applies existing policy, evaluates adherence
to existing policy, or ensures consistency among decisions.
The evaluation consists of simple comparisons among products.
The evaluation requires no separate documentation (such as
a scientific review) beyond the decision itself.
c. Substantive amendment. EPA proposes a category termed
``substantive'' amendments. This type of application would parallel the
``other'' category of new registrations, and would encompass all
amendments that are neither ``major new uses'' nor ``minor''
amendments. This category consists of amendments that require the
review of any scientific data.
Most changes in label precautionary statements or use directions
are included in this category, as well as many changes in product
composition. Inclusion of such a wide variety of amendments in this
category simply reflects the fact that these changes require the review
of some data. The data may consist solely of bridging or confirmatory
chemistry, toxicity, or efficacy data to demonstrate that the product
and its uses, as modified, would not significantly increase risks, or
that the product as modified remains efficacious. Moreover, the review
may be a cursory evaluation of existing data to determine that the
amendment is adequately supported. Nonetheless, the defining
characteristic of a substantive amendment is the need to review some
data, either submitted by the applicant or cited from Agency files.
This category is the only one in the statute that carries a range
of review periods (90 to 180 days), a provision that recognizes the
variety of amendments that can conceivably be proposed to a
registration. Arguably, the inclusion of a range of review periods
suggests that there are gradations of application types within this
range--applications that are relatively less complex that could fall at
the short end of the review period (90 to 120 days) and others that
require the full 180 days. Under this interpretation, EPA could be
expected to establish by regulation subcategories of application to
which a specific review period within the 90- to 180-day range would
apply. Equally consistent with the statute would be an interpretation
holding that the range was included simply to allow EPA the flexibility
to deal on a case-by case basis with the wide variety of amendments
covered by this category, and that no further differentiation or other
regulatory treatment is required.
EPA adheres to the latter view. EPA does not believe that it is
statutorily obligated to establish subcategories of 90- to 180-day
substantive
[[Page 50685]]
amendments. EPA has not discerned any great benefit to the Agency in
doing so, especially by regulation, while noting a number of
disadvantages. A proliferation of categories in itself creates
administrative burdens for EPA in tracking applications. The more
categories that are created--each having its own description against
which applications must be judged and a distinct review period--the
more time it takes EPA generally to administer a tracking system and
ensure that review periods are met. Likewise, the more EPA is bound by
regulatory categories and review periods, the less flexibility the
Agency has to respond to changing review needs or critical priorities
without running afoul of its regulations. EPA is not precluded from
adopting administrative subcategories if it does not choose to adopt
regulatory ones. Moreover, it is not clear that there would be
significant benefits to applicants in gaining a decision 30 to 60 days
earlier that would justify the additional administrative burden for
EPA. Accordingly, EPA is not proposing any specific subcategories.
Under today's proposal, all substantive amendments would be afforded
the same review period, that is, a maximum of 180 days.
In its stakeholder meetings over the past year, however, industry
representatives requested that EPA solicit comment on whether
subcategories should be established. Suggestions from the Chemical
Specialties Manufacturers' Association (CSMA) included the following,
all of which would be classified as substantive amendments:
1. Amendment with data to add a ``me-too'' use that requires full
toxicology and efficacy review.
2. Amendment with data to change a formulation that requires full
toxicology and efficacy review.
3. Amendment with data to modify a label requiring a toxicology or
efficacy review.
4. Amendment without data to modify a label which requires a
toxicology or efficacy review.
EPA solicits comments on these and other sub-categorizations and
review periods. Commenters should consider the following factors
important to EPA's decision:
A suggested category must be capable of unambiguous
description. EPA would likely not consider a category of uncertain
description that could be subject to dispute between applicants and the
Agency.
A suggested category must be meaningful in terms of both
numbers of applications likely to fall in that category and in the
suggested shorter review period. A category that includes relatively
few amendments would be equally unsatisfactory as one that includes too
many amendments. A suggested review period with less than a 30-day
decrement (180 to 160 days for example) would likely not be considered
meaningful. Nor would EPA likely adopt a category with a suggested
review period of 90 days, since there would then be no distinction
between that subcategory of substantive amendment and a minor
amendment.
A suggested category must be comprised of amendments that
can be reviewed within a review period of less than 180 days without
jeopardizing EPA's ability to meet other review periods. EPA is
committed to making decisions on applications as rapidly as possible,
and currently is meeting the review period goal of 180 days
consistently for all substantive amendments, but without consideration
of subcategories.
If commenters persuade EPA that additional subcategories should be
established, and that the benefits of less than 180-day decisions
outweigh the added administrative burdens (bearing in mind that the
Agency has limited resources and that additional administrative burdens
mean fewer resources for reviewing applications), EPA may in the final
rule adopt one or more subcategories of substantive amendments that
would refine the review period within the 90- to 180-day range. EPA
will not consider subcategories of any types of applications other than
substantive amendments.
E. Consultations During the Application Process
Because EPA is required to process complete applications for
registration within judicially reviewable timeframes, it is critical
that applications and data be complete and conform to Agency
requirements, and, as much as possible, that applicants and the Agency
have a common understanding of requirements and expectations about the
process and its outcomes.
EPA recognizes that the registration process can be complicated for
persons who are unfamiliar with FIFRA and its requirements; even for
those who deal routinely with the Agency, keeping up with new policies
and procedures can be challenging.
In the past, deficiencies in applications or data have been
resolved during or after the review process, either informally, for
example with a telephone call for a minor problem, or formally, by
rejecting an application with significant deficiencies. The current
review process has tended to encourage consultation only after an
application has been rejected, when EPA can explain both the results of
its review and what an applicant needs to do to correct deficiencies.
Pre-submission consultation has not typically been the case with
antimicrobial products.
With the completeness of an application at stake for an applicant,
and strict review periods in place for EPA, it makes sense for both to
consult as much as is practicable and as early as possible.
Misunderstandings about requirements and expectations may lead to
needless determinations of incompleteness or denial for the applicant,
while impeding EPA's ability to reach decisions in a timely fashion as
required by the statute.
EPA encourages consultation with the Agency on any application
prior to a determination of completeness. However, the majority of
antimicrobial applications are for so-called ``me-too'' products and
uses, those which are identical or substantially similar to others
already registered. Such applications are relatively easy to submit
correctly, seldom raise new or controversial issues, and should not
routinely require specific consultation. Once an application has been
determined to be complete, and has been placed in review, the applicant
should not need or expect to consult the Agency until the end of the
appropriate review period (which for ``me-too'' products is only 90
days), or until EPA notifies the applicant of a deficiency.
However, EPA has identified two areas where it believes advance
consultation is essential to the submission of a complete application,
and proposes in Sec. 152.447 to require pre-submission consultation.
The first is applications for new chemicals and major new uses. These
consultations, which are common for agricultural chemicals but rare for
antimicrobial chemicals, help the applicant and the Agency agree upon
data requirements, data waivers, or issues that typically arise for new
chemicals and major new uses (such as food use status).
In addition, EPA proposes to require pre-submission consultation
whenever an efficacy test protocol or method must be approved by the
Agency either because there is no protocol or because the applicant
wishes to modify an exising protocol.
The regulation does not prescribe how consultation is to be
accomplished. There is no requirement that a required consultation
occur in a meeting; a conference call, letter, or other form of
[[Page 50686]]
communication may be sufficient, depending on the nature of the new
chemical, new use, or protocol approval needs. However, proposed
Sec. 152.447 emphasizes that any regulatory determinations must be in
writing. EPA expects the applicant to follow up any consultation with a
summary of any decisions so that EPA may confirm them in writing.
Proposed Sec. 152.450 would require written documentation of a
consultation describing the substance of the consultation to be
submitted with the application to verify that the consultation took
place as required.
In turn, EPA would commit to adhere to the decisions agreed upon in
a pre-submission consultation unless the circumstances of the
application change, its determinations were in error, or a question of
adverse effects arises.
F. Contents of Applications
1. What the statute requires. FIFRA section 3(h) requires formal
Agency review only upon submission of a ``complete'' application, and
requires that EPA clarify its criteria for completeness of an
application. Current regulations in 40 CFR 152.50 describe the contents
of an application for registration, including applications for
antimicrobial products. EPA proposes in subpart W an expanded and more
detailed description of the contents of a complete application,
including some new elements of an application not currently required.
2. Definition of complete application. First, EPA is proposing a
general definition of ``complete application'' in Sec. 152.3, a
definition that would apply to all applications for registration. Other
provisions of FIFRA also link Agency priority, review or action to
completeness of an application, for example, the fast-track and minor
use provisions of section 3(c)(3), and the expedited review provisions
of section 3(c)(10). The general definition is repeated in Sec. 152.442
to apply to antimicrobial applications.
The definition draws a distinction between the completeness of the
application itself (which allows EPA to commence formal Agency review),
and the completeness of the information needed for EPA to approve the
application. It is relatively easy to define a core set of items--
forms, labels, routine and uncomplicated data--which, if present in an
application, suffice to begin review. But completeness for Agency
decision purposes encompasses an element of ``adequacy'' that, for many
applications, can only be determined on a case-by-case basis, and only
during or after substantive review of the application. Accordingly, the
decision by EPA that an application is ``complete'' (and, for
``antimicrobial pesticides,'' that begins a review period), represents
only a preliminary or interim determination of overall completeness
intended to allow EPA to initiate formal review.
Completeness becomes a question of adequacy as the amount of
scientific data and the complexity of the risk assessment increase.
Typically, applications for new chemicals or new uses, and actions
involving food uses or increased non-dietary exposures require more
data. FQPA significantly expanded the scope of dietary risk assessment
under the FFDCA, particularly for infants and children.
Correspondingly, EPA will be enhancing its non-dietary assessment of
risks to infants and children, such as might occur with antimicrobial
pesticides. However, ``fast-track'' or ``me-too'' applications that
require little or no scientific review comprise the bulk of
antimicrobial applications submitted to EPA. These actions are
relatively straightforward as to application and approval criteria and
EPA expects that the completeness determinations for review purposes
and for approval of the application generally would be equivalent. For
these types of applications, EPA would be less likely to find during
its formal review that it requires data or information beyond that
provided at the time of application.
3. Contents of an antimicrobial application. FIFRA section 3(h)
requires that, in its final regulation, EPA clarify criteria for
determination of the completeness of an application for antimicrobial
pesticides. EPA is proposing in Sec. 152.450 detailed requirements for
applications, which, if satisfied, would allow a preliminary
determination of completeness.
Current requirements in Sec. 152.50 form the basis for the
requirements in proposed Sec. 152.450, but EPA proposes an expanded
level of detail. Table 3 below sets out each element of an
antimicrobial application as proposed today. Column 1 identifies the
application requirement. Column 2 gives the reference in proposed
Sec. 152.450 of the requirement. Column 3 gives the cross-reference to
Sec. 152.50, or indicates that the requirement is new. New elements are
discussed more fully afterwards. Column 4 provides explanatory notes,
indicating that a requirement is unchanged from current requirements,
or describing additions or changes for antimicrobial applications.
Table 3.--Contents of an Antimicrobial Application for Registration
----------------------------------------------------------------------------------------------------------------
Explanatory notes/
differences for
Requirement Sec. 152.450 reference Sec. 152.50 reference antimicrobial
applications
----------------------------------------------------------------------------------------------------------------
Application form (a) (a) Unchanged. Detail is
provided on the
elements and
completeness of the
form.
----------------------------------------------------------------------------------------------------------------
Authorization for agent (b) (b)(3) Unchanged.
----------------------------------------------------------------------------------------------------------------
Summary of application (c) (c) Unchanged. This summary
and that required for
results of studies may
be consolidated.
----------------------------------------------------------------------------------------------------------------
Statement of formula (d) (d), (f)(2) Unchanged. The Statement
of Formula includes
both product identity
and composition.
----------------------------------------------------------------------------------------------------------------
Draft labeling submission (e) (e) Unchanged. Detail is
provided on the
presentation and
completeness of the
labeling submission.
----------------------------------------------------------------------------------------------------------------
Method of support documentation (f) (f)(1) Unchanged. Consists of
forms and information
required to demonstrate
compliance with data
compensation
requirements of FIFRA.
Sec. 152.450
summarizes the existing
methods of data
support.
----------------------------------------------------------------------------------------------------------------
Data (g) (c), (f)(2) Unchanged.
----------------------------------------------------------------------------------------------------------------
[[Page 50687]]
Adverse effects information (h) (f)(3) Unchanged. The proposal
clarifies that such
information is not
required with an
application for
amendment.
----------------------------------------------------------------------------------------------------------------
Tolerances or other food clearances (i) (i) Unchanged.
----------------------------------------------------------------------------------------------------------------
Consultation documentation (j) New If a pre-submission
consultation occurred
under Sec. 152.447, or
decisions or agreements
were made at an
optional consultation,
the applicant would be
required to provide
documentation of that
consultation.
----------------------------------------------------------------------------------------------------------------
Data reviews conducted by other (k) New If reviews have been, or
regulatory authorities are being, conducted by
other regulatory
authorities, the
applicant would be
required to submit
those that are
available.
----------------------------------------------------------------------------------------------------------------
Other clearances (l) Not previously in Unchanged. Applicants
regulatory form are currently required
to provide evidence
that the applicant has
requested clearances
required by other
Agencies.
----------------------------------------------------------------------------------------------------------------
Packaging (m) (g) Unchanged. Clarifies
that packaging itself
is not to be submitted
with an application
unless specifically
requested by EPA.
----------------------------------------------------------------------------------------------------------------
Product samples (n) Not previously in Unchanged. Clarifies
regulatory form that product samples
are not to be submitted
with an application
unless requested by
EPA.
----------------------------------------------------------------------------------------------------------------
Self-addressed means of EPA (o) New Voluntary submission of
notification a postcard or other
means for EPA to notify
the applicant of a
preliminary
determination of
completeness.
----------------------------------------------------------------------------------------------------------------
Fees (p) Part 152, subpart U Unchanged. Application
fees are currently
suspended. Included
here only for
completeness.
----------------------------------------------------------------------------------------------------------------
Authorization to share data and data (q) New Optional. The applicant
reviews is requested to
authorize EPA to share
either data or EPA
reviews of data with
State, Federal,
national, or
international
regulatory authorities.
----------------------------------------------------------------------------------------------------------------
4. New required elements of applications. Only three required
elements of an application are entirely new in today's proposal.
Proposed Sec. 152.450(j) would require that applicants submit
documentation of the results of pre-submission conferences, either
those required by Sec. 152.447 or optional ones, at which regulatory-
related decisions were discussed or agreements reached. The
documentation could be minutes of the meeting that EPA has reviewed, or
could be a letter from EPA confirming the decisions reached or
approving a specific test regimen or protocol.
Proposed Sec. 152.450(k) would require the applicant to submit
available reviews of the application, or of individual studies, that
have been conducted by other regulatory agencies or organizations. If
an application has been submitted for regulatory review elsewhere, the
applicant would be required to inform EPA of that fact. Applications
may have been submitted concurrently to international regulatory
bodies, or to Federal Agencies or States. If EPA is able to use the
results of reviews conducted elsewhere, it will save time and resources
in reaching a decision on the application, which may allow earlier
entry into the marketplace. An applicant would not be required to
either await the results of ongoing reviews or to specifically obtain
copies of the reviews to submit with his/her application. However, if
reviews have been provided, the applicant would be required to submit
them to EPA with his/her application.
Proposed Sec. 152.450(l) would require that applicants provide EPA
with documentation that they have received (or have applied for) any
other clearances from Federal agencies that might be necessary to
market or use the product. EPA currently requires such documentation
before issuing a registration bearing the use in question. Submission
with the application of evidence that the clearance has been requested
or obtained would help assure EPA that the applicant is fully aware of
its obligations under other laws. Ensuring that all regulatory
clearances are underway concurrently also makes the review periods for
EPA meaningful. EPA approval of an application within a review period
would have little meaning if the applicant cannot market the product or
users cannot use it because additional clearances are needed.
5. Non-mandatory or clarified elements of applications. Four
further elements of the antimicrobial application are either clarified
by inclusion of explanatory language, or are voluntary information.
Proposed Sec. 152.450(m)(2) clarifies that product packaging is not
to be submitted unless requested. The submission of labeling is
accomplished using draft typescript copies or mock-ups that are
suitable for microfilming and filing.
Proposed Sec. 152.450(n) clarifies that applicants are not to
submit actual product samples with an application unless requested. EPA
typically requires samples of active ingredients or analytical
standards in conjunction with
[[Page 50688]]
setting tolerances. EPA may also request samples of antimicrobial
pesticides bearing public health claims for EPA evaluation of efficacy.
In each case, EPA will separately request such samples and instruct the
applicant how and where to provide them.
Proposed Sec. 152.450(o) provides that applicants who wish to be
notified whether an application is preliminarily complete (and
therefore has been placed into review with a review period) furnish EPA
with a means of notifying them. This could take the form of a postcard,
form letter, or other means of such notification. Without an easy means
of notification, EPA cannot commit to written notification. Nor will
EPA use notification methods such as telephone or e-mail that cannot
properly be documented by an authorized signature as EPA-originated,
although advances in technology may make this feasible in the future.
Finally, EPA would notify the applicant only at the time the
application is determined to be complete; at that time the formal
review period would have started, and EPA's next communication with the
applicant would normally be a decision on the application
(Sec. 152.455, Action on applications.) EPA would not accept multiple
postcards or requests simply to advise the applicant of the status of
the application review during the review period.
Proposed Sec. 152.450(q) requests, but does not require, that the
applicant provide authorization for EPA to share the data or EPA
reviews of data with other regulatory agencies. The ability to share
data and reviews among regulatory authorities will contribute to
streamlining EPA review processes for antimicrobial products, and is an
essential element in achieving harmonization of reviews.
An applicant who intends to market a product in the United States
may be required to register the product with individual States; an
applicant who intends to market the product abroad (such as in Canada)
must meet the regulatory requirements of other countries. While the
depth of regulatory scrutiny of a product varies among States and
countries, many require the submission of equivalent amounts of data as
the applicant has submitted to EPA. The ability to share data submitted
to one regulatory authority with others can reduce the paperwork and
review burden of all by reducing multiple identical submissions and
allowing the sharing of the review load. EPA already is engaging in
work-sharing efforts with the State of California and with Canada.
This effort can be complicated by confidentiality claims under
FIFRA section 10(b) or the disclosure restrictions of section 10(g).
Section 10(g) permits the Agency to disclose data in support of
registration only to those who affirm that they will not further
disclose the information to foreign or multinational pesticide
producers. Although a mere claim of confidentiality under FIFRA section
10(b) does not conclusively prevent disclosure of information, it does
require the Agency to follow certain procedures (which may include
obtaining a substantiation of the claim from the registrant) to
determine whether the information is entitled to confidential
treatment. These procedures can interfere with free and unimpeded
exchange of information and data among regulatory authorities.
On November 27, 1985, EPA issued Class Determination 3-85 (50 FR
48833). EPA declared as non-confidential (and not subject to the
disclosure restrictions of FIFRA section 10(g)) reviews of data that do
not contain information which would disclose: (1) Manufacturing or
quality control processes; (2) the details of any methods for testing,
detecting, or measuring the quantity of any deliberately added inert
ingredient of a pesticide product; (3) the identity or percentage
quantity of any deliberately added inert ingredient of a pesticide
product; (4) unpublished information concerning the production,
distribution, sale, or inventories of a pesticide (such information
might appear in reviews which discuss the amount of a pesticide sold or
used in a given time, and thus might concern the significance of data
from a test or experiment); (5) any complete unpublished report
submitted to EPA by a registrant or applicant; or (6) excerpts or
restatements of any such report which reveal the full methodology and
complete results of the study, test, or experiment, and all explanatory
information necessary to understand the methodology or interpret the
results.
Agency data reviews are normally drafted to avoid inclusion of
information that is within the six categories described in the
paragraph above, but EPA cannot guarantee that all reviews will meet
these criteria. Moreover, as discussed above, the Agency may have a
need to share raw data in addition to study reviews with States and
other countries.
EPA believes it is in the interest of both applicants and the
Agency to have free and unimpeded exchange of information and data
among regulatory authorities. To that end, this proposal requests that
applicants authorize such exchange at the time of application. Sharing
data and reviews with other regulatory authorities would not compromise
the protection against disclosure provided by section 10, because such
sharing would not constitute a public disclosure of the information.
To authorize data- or review-sharing, the applicant would submit a
statement authorizing EPA to share either any data submitted with the
application or EPA's reviews of such data with regulatory authorities
as needed. An appropriate permission statement would be similar to the
following:
This letter grants permission for EPA to share all data submitted
with this application, EPA reviews of data submitted with this
application, with State, other U.S. Federal, or other national
regulatory authorities. This authorization does not waive any
restrictions on public disclosure of the data reviews.
G. EPA Action on Applications
1. Completeness screens. EPA currently screens all applications for
completeness, not just antimicrobial applications. The Office of
Pesticide Programs Front End Processing Unit (FEPU) receives all
applications, processes them administratively, and conducts a simple
screen to ensure that required application items are present and
properly submitted. An application accompanied by data is subsequently
screened for submission and format requirements of the data itself.
Data submissions must include specific items prescribed by Agency
regulations in 40 CFR 158.32 and 158.33, as well as meet format and
presentation requirements detailed in PR Notice 86-5. Neither of these
screens evaluates the substance of the application or the data. In
either the FEPU or data screen, EPA may identify deficiencies that must
be corrected. Depending on the nature of the deficiency, the
application may be placed into review anyway, and deficiencies
corrected during the review process. This informal screening and
correction process has served the Agency and applicants well over the
years.
Nonetheless, because FIFRA directs EPA to develop completeness
criteria, and because antimicrobial pesticides are now subject to
review periods, which are computed only if an application is determined
to be complete, it is imperative that EPA not only establish more
formal criteria for completeness, but that EPA conduct a more rigorous
completeness screen before determining even preliminarily that an
application is complete. Section 152.455 of today's proposal describes
what actions EPA
[[Page 50689]]
may take on complete and incomplete applications.
2. Preliminary determination of completeness. In addition to the
FEPU administrative screen and the data review screen, the
Antimicrobial Division has instituted a more in-depth screening process
to ensure that only applications that meet the standards of proposed
Sec. 152.450 enter formal Agency review. The antimicrobial screening
process builds on the earlier screens in two ways: by evaluating the
adequacy of certain application items that are typically not evaluated
in a simple administrative screen (e.g., are clearly required studies
included?), and by evaluating application requirements peculiar to
antimicrobial pesticides (e.g., efficacy data requirements).
Based on this screen, EPA would make a preliminary determination
whether an application is complete (proposed Sec. 152.455(a) and (b)).
If the application is incomplete, EPA would notify the applicant,
describe the deficiencies and await resubmission by the applicant. If
complete, and a self-addressed notification has been provided in
accordance with proposed Sec. 152.450(o), EPA would notify the
applicant of the determination, compute the date under proposed
Sec. 152.457 when a decision may be expected (calculated from date of
receipt of the application), and place the application into formal
review. If no self-addressed notification is provided, EPA would place
the application into formal review, but would not notify the applicant.
Because some elements of completeness cannot be evaluated until the
application is reviewed in depth, a determination of completeness
sufficient to place the application into formal review must, of
necessity, be a preliminary one.
EPA is likely to apply its completeness criteria very strictly, for
several reasons. Strict application of completeness criteria appears to
be consistent with the statutory direction to base enforceable
deadlines on completeness determinations. Further, consistent treatment
of applications is more likely if EPA establishes and adheres to
relatively ``bright line'' criteria for completeness. Finally, the
sheer number of applications that EPA receives means that it must
allocate its review resources very carefully. EPA does not believe it
unreasonable to use completeness determinations as a management tool
for those resources. While refusing entry into review for a minor
deficiency may appear inflexible, it is important to recognize that
what is flexibility for one applicant may appear to be inconsistency or
inequity to another. EPA believes that lack of completeness criteria
and inconsistent application of such criteria have been a source of
applicant dissatisfaction.
3. Effect of incompleteness determination on review period.
Regardless of when a determination of incompleteness is made, the
consequence is the same: the review period would either not be computed
or would be halted and recomputed anew upon receipt of all items
completing the application. EPA would notify the applicant that the
application is incomplete, and specify how it can be made complete.
4. Applicant resubmission. Proposed Sec. 152.455(b) specifies that
EPA will deem the review period to have begun only upon receipt of the
last item that completes an application. Partial information clearly
does not satisfy the completeness criteria, or allow the application to
be placed into review. EPA discourages applicants from correcting
application deficiencies in a piecemeal fashion; nonetheless,
historically this has happened (and been tolerated by the Agency)
because some deficiencies are easy to correct (a form not signed, an
unreadable draft label), while others may take longer (a missing
required study).
An applicant may wish to resubmit rapidly what can be readily
corrected, and EPA may wish to accommodate the applicant's desire to
begin review of available information. As noted earlier, under the
current application review system, both of these can often be
accommodated. EPA frequently is requested and agrees to place an
application into review while waiting for some item that has not yet
been submitted, expecting that the missing item can ``catch up'' before
it is needed for review. Under the tight review periods provided for
antimicrobial application review, however, EPA cannot afford the time
and resources that may be lost if an applicant fails to provide the
needed information in a timely manner. Other applicants also suffer
because their applications are not reviewed as promptly as possible.
Accordingly, EPA would not place an application into review until all
deficiencies are corrected, and a preliminary determination of
completeness can be made.
5. Agency review. Once EPA has issued a preliminary determination
of completeness, EPA will place the application into substantive Agency
review. EPA conducts scientific reviews in parallel as much as
possible, although some reviews depend upon the results of others and
must be conducted sequentially. Proposed Sec. 152.455(d) specifies
that, once in review, EPA will complete all reviews for the application
before issuing a decision of any sort, even a determination that the
application remains incomplete. EPA intends, however, to continue, to
the extent practicable, its longstanding practice of communicating
informally with applicants about interim results of reviews as they are
completed. Informal communications are not Agency decisions on the
application itself, and are entirely at the Agency's discretion.
6. EPA decisions after review. Section 3(h)(3)(F)(i) provides that:
[T]he Administrator shall notify an applicant whether an
application has been granted or denied not later than the final day
of the appropriate review period under this paragraph, unless the
applicant and the Administrator agree to a later date.
This provision is probably the single most significant element of
the overall antimicrobial reform effort mandated by FIFRA. All process
improvements and efficiencies directed elsewhere in FIFRA section 3(h)
are for the purpose of shortening review periods to the goals specified
in FIFRA section 3(h)(2). This provision holds EPA to a decision within
the review periods that would be established under this proposal. EPA's
failure to meet those review periods is judicially reviewable.
EPA takes seriously its mandate for antimicrobial process reforms:
meeting its review period goals is the most visible and tangible
evidence of the success of its reforms. Hence, how EPA implements this
provision, both in making decisions and in managing the review period
process, is critical.
EPA review must culminate in one of two specified decisions--
approval or denial--by the end of the review period. The ``review
period'' can be either that established in proposed Sec. 152.457, or an
extended review period agreed to between an applicant and EPA. The
statute does not provide for negotiated shorter review periods; those
that would be established under this proposal are minimum review
periods that would apply unless extended by agreement.
The statute is silent on whether EPA may take other unspecified
actions prior to the expiration of the review period and what those
actions might be, but clearly no action other than approval or denial
is authorized at the end of the review period. EPA believes that it is
within its discretion to take interim actions prior to the expiration
of the review period, as long as the final decision on an application
is either approval or denial. Interim actions might include
communications with applicants on the application, preliminary
indications of
[[Page 50690]]
incompleteness or other deficiencies that might lead to denial, or
notice of the Agency's intent to approve the application.
Approval is of course the desired decision from the applicant's
point of view. If the application is complete and relatively
uncomplicated, reaching a decision within the review period is mostly a
function of efficient management of the review process. The bulk of the
antimicrobial applications that EPA receives are for so-called ``me-
too'' products and amendments (those with review periods in the range
of 90 days). These can be fairly characterized as uncomplicated, and
problems with completeness are more likely to be the reason for delays
in approval than the complexity of the review or decisionmaking
processes. Delays due to incompleteness are not included in EPA's
review period. A rigorous application of the completeness criteria of
proposed Sec. 152.450 to weed out incomplete applications should enable
EPA to reach a decision within the review period for applications that
are complete.
For applications of greater complexity--new chemicals, major new
uses and other products and uses that are not substantially similar--
the decision process is not a straightforward one-time review leading
to a single decision point of approval or denial. Rather it involves a
series of decisions, with stops and starts in the process as the
application progresses. Typically, such an application goes through
several cycles of review. Under current practice, EPA commences review
of an application and often determines that it is incomplete,
inadequate, or raises risk or efficacy concerns that must be addressed.
The Agency notifies the applicant and places the application into
pending status until the applicant responds. The ``down time'' awaiting
applicant response varies considerably based on the type of problem,
but if a new study is required, may be from 6 months to 2 years. For
the most complex applications, those for new chemicals and major new
uses, the cycle may be repeated several times. Thus, the total elapsed
time from beginning of review to an approval or denial decision may be
lengthy, but the length is generally not attributable solely to EPA
inaction or delay. The time may be marked by interruptions when the
application is awaiting applicant action and not EPA action.
In the current review process, an interim decision is not a denial,
which carries the right to administrative appeals. EPA refers to such a
decision as a ``rejection,'' a term used to reflect the interim
incomplete status of the application and of EPA's review.
The provision in FIFRA section 3(h) that EPA must reach a decision
within a specified review period is silent on whether or how the review
period should accommodate the cyclical nature of the review process, in
which EPA review time and applicant response time typically alternate.
A strict interpretation of the provision would be that the review
period includes applicant ``down time.''
Congress rightly anticipated that EPA might reasonably need a
longer review period in certain circumstances, and the statute
contemplates, but does not specify, a process for reaching agreement on
a longer period for the formal approval or denial decision. The
excepting clause, ``unless the applicant and the Administrator agree to
a later date,'' while not perfect in that it does not reflect the
reality of the review process, does allow EPA and the applicant, by
agreement, to extend the total review period. An agreement on extension
could be tailored to account appropriately for applicant ``down time,''
without penalizing EPA or subjecting the Agency to the threat of
judicial review. EPA believes that this clause provides much-needed
flexibility both in the types of actions that EPA may take and the
process by which an appropriate review period is to be agreed upon.
Regardless of the reasons for needing an extension, EPA cannot
afford to engage in case-by-case negotiation for every application that
might approach the end of its review period without a decision. To
reflect more closely the actual review process, EPA needs to be able to
take actions before the end of the review period that have the effect
of extending the overall review period by stopping it for some period
of time. Without such flexibility, EPA may be compelled to use its
denial authority more frequently to meet the statutory requirement to
issue a decision.
EPA does not intend to violate its regulations by failing to make
decisions in a timely manner. If EPA is unable for any reason to issue
a decision on an application within the review period, and cannot agree
with the applicant on an extension, EPA's failure permits the applicant
to seek judicial review. EPA views the judicial process as the least
desirable means of resolving disputes over the review period. Not only
is it time-consuming and costly for both parties, but a predictable
result of judicial review is that a court would order EPA to complete
review within some further period of time, an outcome which has the
same effect on the review schedule as if EPA and the applicant had
agreed to an extension.
EPA's alternative course of action, permitted by the statute, is
simply to deny the application. Denial would be governed by the
provisions of FIFRA section 3(c)(6), which permits an administrative
hearing process. While EPA may thereby satisfy the requirement to issue
a decision and avoid the threat of judicial review, the Agency believes
there is little value added by the administrative hearing process,
which can be as protracted, costly, and uncertain as judicial review.
Nor does EPA believe that applicants, many of whom are small companies
without substantial financial or technical resources, are well served
by either an administrative or judicial process in this particular
context. Their objective is presumably to obtain an EPA decision in the
most timely manner and without extraordinary effort or cost on their
part.
Given that individual negotiation is not feasible for any large
number of applications, that EPA and applicants may reasonably disagree
on the need for or length of extension, and that neither judicial
review nor denial of the application is an appealing means of resolving
such disputes, EPA believes it prudent to establish rules for
implementation of review periods that build in provisions for
extension. Today's proposal would do so, while not foreclosing the
opportunity for case-by-case extension agreements when warranted.
Accordingly, EPA proposes in Sec. 152.455 a series of possible
decisions arising from substantive Agency review, incorporating
proposals for dealing with extensions. These are: (1) The application
may be approved; (2) the application remains incomplete; (3) the
applicant has failed to furnish sufficient information to determine
whether the application may be approved (two circumstances with
different consequences for the review period); and (4) denial for
cause.
7. Approval. If EPA approves the application, it would follow its
customary procedures to notify the applicant by issuing a Notice of
Registration or letter of approval for an amendment and sending back a
stamped copy of the approved labeling if called for.
8. Opportunity for rebuttal. EPA frequently issues a registration
that is conditioned upon the applicant's making certain corrections or
modifications to the registration before sale or distribution. Such
terms and conditions generally only require changes which are minor in
nature and
[[Page 50691]]
most often consist of labeling changes to be consistent with similar
products, adhere to Agency policies, or clarify label statements. In
EPA's experience, virtually all new registrations require some
modification to the label; for this reason EPA requests and approves
draft labeling as part of the application, and requires that the
applicant submit final printed labeling prior to sale or distribution
of the product.
EPA's approval of the registration and permission to distribute or
sell the product is premised on the applicant's acceptance of EPA's
terms and conditions. Proposed Sec. 152.455(d)(1) would permit
applicants who disagree with the terms or conditions of EPA's approval
to submit an objection within 30 days of receipt of registration. In a
process analogous to the appeals process for notifications in FIFRA
section 3(c)(9), EPA would review the applicant's arguments and issue a
final decision. EPA would try to review the objection and render a
decision within 45 days of receipt by the Agency. It should be kept in
mind that EPA's limited resources must be devoted first and foremost to
its review period obligations for application decisions; EPA cannot
promise that objections to decisions already made will receive equal
attention.
9. Determination that the application remains incomplete. EPA may
decide that, notwithstanding its preliminary determination of
completeness, the application remains incomplete. One reason EPA might
determine incompleteness is if the deficiency is the result of the
applicant's failure to follow well-established and clearly stated
guidance, procedures, or policies. Such ``incompleteness'' could be
identified when studies are reviewed in depth and found not to have
been conducted in a manner that provides EPA with adequate information
on which to reach a decision on the application. This type of
incompleteness would normally be discovered only during substantive
review. EPA cannot however, preclude the possibility that some
deficiencies could be overlooked at the earlier preliminary
completeness screening.
EPA expects that it would choose to use the incompleteness
determination only rarely after an application is preliminarily
determined to be complete, electing instead to deny the application or
seek agreement with the applicant on an extension of the review period.
Applications having relatively short review periods (120
days) are generally straightforward enough that EPA believes it would
catch most incomplete applications at the earlier preliminary
completeness screening phase. EPA believes there should be few ``me-
too'' type applications that are determined to be incomplete after
entering formal review. EPA would rarely seek to extend the original
review period for these short-term applications since it is
considerably easier in Agency tracking systems to close out a review
period altogether than to track an extension. Tracking the review
period is a time-consuming operation. EPA does not believe it should
devote its scarce resources to tracking an original review period
through a series of short-term extensions. This is especially true
given the high volume of applications that fall into the
120-day review period.
With respect to longer review period applications (120
days), EPA might choose to determine that an application is incomplete
if a deficiency is discovered early in the review process (e.g., in the
first 90 days of a 270-day review period).
If, at later points in a lengthy review period (e.g., 200 days into
a 270-day review period), EPA judges an application to be deficient for
reasons attributable to incompleteness, the Agency would want to
examine why this is occurring. Why are incomplete applications being
submitted and not being identified earlier in the process? Over time,
as process improvements continue to be put in place and EPA and
applicants familiarize themselves with new procedures and requirements,
EPA expects that incompleteness determinations after beginning Agency
review would decrease. Nonetheless, EPA must reserve to itself the
right to determine after placing an application into formal review that
the application is actually incomplete.
EPA is not obligated to begin review of or compute a review period
for an application that is incomplete. If EPA determines after putting
the application into formal review and computing a review period that
the application is incomplete, EPA would normally stop the review,
notify the applicant of its incompleteness, and recompute a new review
period upon receipt of submission completing the application. Proposed
Sec. 152.455(d)(2)(ii) specifies this typical result.
10. Qualifying resubmission for incomplete applications. However,
in its discretion, EPA proposes in Sec. 152.455(d)(2)(i) to offer
applicants somewhat more flexibility in Agency review periods if the
incompleteness determination occurs after putting the application into
formal review and if completing the application can be accomplished on
an accelerated basis. For applications having short review periods
(120 days) and minor incompleteness deficiencies, EPA
believes that it need not necessarily take the full review period that
it would be entitled to when the complete application is resubmitted.
Generally, if a minor deficiency can be corrected within 30 days after
notice to the applicant, EPA proposes to term that resubmission a
``qualifying resubmission'' and to complete review within a shorter
review period than would otherwise be computed. In general,
Sec. 152.455(d)(2)(i) proposes a subsequent review period 30 days
shorter than the original base review period for that type of
application, i.e., 60 days instead of 90 days for an identical or
substantially similar application, and 90 instead of 120 days for an
``other new application.'' The choice to offer an abbreviated review
period is entirely within EPA's discretion; EPA could instead take its
entire review period.
EPA proposes to limit such ``qualifying resubmissions'' to
applications having a review period of 120 days or less. EPA believes
that the incompleteness deficiencies likely to arise in such
applications would generally not be multiple deficiencies and are less
likely to involve serious data deficiencies. By contrast, EPA review of
an application for a new active ingredient or major new use would in
all probability identify multiple deficiencies, including data
deficiencies, not amenable to correction within 30 days.
11. Determination that the applicant has not submitted all needed
information. If there are deficiencies other than incompleteness
deficiencies, the Agency may determine that the applicant has not
provided sufficient data or information to make a decision on the
application. EPA proposes two procedures (termed Cases 1 and 2); which
would apply to any particular application would depend upon the nature
of the deficiency. In each case, EPA would stop the review period as of
the date that it notifies the applicant of this decision. In neither
case would the review period resume until the applicant provided the
necessary information, and elapsed time with the applicant would not be
counted against EPA's original review period. The difference lies in
when EPA would restart the review period (the ``clock''). In Case 1,
EPA would restart the clock immediately upon receipt of a complete
resubmission correcting the deficiencies. In Case 2, EPA would restart
the clock only after an additional
[[Page 50692]]
period after receipt of a complete resubmission.
Case 1 - Immediate restarting of the review clock. If the
deficiency is one that can be rapidly corrected by the applicant and
upon resubmission rapidly reviewed by Agency reviewers without
significant Agency downtime to re-review, refamiliarize, or reconstruct
the decision logic, EPA would restart the clock as of the date that the
applicant resubmitted all information or data required. EPA emphasizes
that EPA would restart the clock only after all deficiencies have been
corrected. The resubmission must also be ``complete.'' The kinds of
deficiencies EPA envisions in this category are short-term studies,
upgrading an existing study, or providing an explanation of such
studies.
If EPA chose this response, the Agency would specify in its notice
to the applicant the deficiencies needing correction, and require that
they be corrected within a relatively short timeframe--based upon the
type of deficiency, probably less than 6 months. If the resubmission
time is too short, the applicant could suggest a longer time for
resubmission. If that resubmission time is considerably longer than EPA
anticipated, such that the Agency would need additional time upon
receipt to refresh its review, EPA would reserve the right to restart
the clock at some later time after resubmission (Case 2).
Case 2 - Delayed restarting of the review clock. For deficiencies
that take longer to correct (e.g., new studies must be generated) or
where interruption of EPA review means that EPA must essentially begin
some portion of its review again, EPA would restart the clock after
both a period for applicant resubmission and an additional time for the
Agency to bring the review and reviewer back up to date. The longer the
interruption of review, the more likely it is that EPA reviewers may
have changed, that policies may have changed or evolved, or that the
original reviewer must refresh his/her knowledge of the product, the
application or the data. In EPA's experience, a review that is
interrupted for longer than 6 months has become stale.
In this case, EPA would notify the applicant, specifying the
deficiencies and requiring correction by a certain date. EPA would also
estimate how long after resubmission the clock would start.
12. Negotiating extended review periods for deficient applications.
FIFRA section 3(h)(3)(F) allows the review period to be extended by
agreement between EPA and applicants. As noted earlier, EPA intends
that this proposal set boundary rules for extending review periods, so
that case-by-case negotiated extensions would be used only
infrequently. Deficient applications for which EPA would stop the clock
and restart it, but where EPA cannot define the specifics of the
resulting extended review period are an area where negotiations would
be appropriate. Individual negotiation might be appropriate, for
example, if the deficiency entailed development of new methodology or
data with which EPA had no prior experience to judge its review time.
Case 1 - Negotiating resubmission dates for simple deficiencies.
EPA anticipates it would provide only a limited opportunity for
negotiation over the appropriate resubmission time for Case 1
resubmissions. EPA's ability to restart the clock immediately upon
resubmission and thereafter to meet the review period deadline depends
on the fact that the deficiency can be corrected rapidly. Simply
restarting the clock is not feasible if protracted negotiations would
result in significant delay in resubmission. EPA's concern is not the
effect of the negotiation per se on the clock (since the clock will
have stopped upon notification of the deficiency), but the fact that
any appreciable delay in resubmission because of negotiation may mean
that the application review would become stale. EPA must strictly limit
the negotiating time for simple deficiencies, or such deficiencies
would, because of the passage of time, have to be treated as complex
deficiencies under Case 2. EPA does not intend in this proposed rule to
define specific types of simple deficiencies for which Case 1 could be
used. However, EPA solicits comment on how this procedure could be
implemented in a realistic manner, and what would be an appropriate
length of time to allow for negotiations to commence and conclude.
Case 2 - Negotiating resubmission dates for complex deficiencies.
Resubmission dates would be more flexible with Case 2 complex
deficiencies. Because the deficiencies are complex, the resubmission is
expected to be on a longer schedule. Since time after notification of a
deficiency until resubmission is on the applicant's clock and not
EPA's, EPA could be flexible both in negotiating and in the
resubmission dates established. Unless the deficiency raised serious
risk concerns for a product already on the market (in which case EPA
likely would consider denying the application), EPA believes it could
generally accommodate applicant needs for resubmission.
In addition to interruption of the review period while the
applicant corrects deficiencies and resubmits to the Agency, Case 2
negotiations would need to build in an additional period of time for
EPA to ``refresh'' the application review before the review period
clock would start. The appropriate length of this ``delay time'' is
less easily determined and more likely to be an issue that requires
negotiation between EPA and applicants. EPA is not proposing either
specific delay times or criteria for determining appropriate delay
times in this document, but is proposing to establish the ``delay
time'' as a regulatory decision.
The delay time could be based on several factors. First, the delay
time could be a function of the actual time needed for review of the
submitted material (which may be one or more new studies). EPA could
develop some general timeframes for review of particular types of
studies, for example, a standard review time for a chronic toxicology
study or an indoor exposure study. These would serve as a starting
point for determining the delay time. If EPA develops such standard
review times for studies, it would share these with registrants and
others before implementing them.
Second, the delay time could also include the time needed for EPA
to bring the review and reviewers back up to speed, to adjust for new
reviewers, and, once completed, to integrate the new material into the
application review and risk assessment. The longer the clock has been
stopped and the application put aside, the longer the time needed to
refresh it and the more likely that changes in personnel or policies
will have occurred. These times are more variable, but may depend in
part on the complexity of the application type. The definitions of
application types in proposed Sec. 152.445 roughly track the complexity
of an original application review and therefore how much re-review
might be needed to come up to speed later. EPA expects that the types
of deficiencies that would trigger a delay time typically would be
associated with new chemicals and major new uses.
Finally, the delay time must of necessity take into account
variable external factors such as competing priorities and workload and
resource balancing. As a practical matter, although EPA may be able to
roughly estimate the delay time when it notifies an applicant of a
deficiency, the actual delay time may be dictated not by circumstances
at the time of notification, but by circumstances at the
[[Page 50693]]
time of resubmission. Depending on the nature of the deficiency, and
whether new studies must be generated, resubmission could be a year or
more away. In that time, substantial changes may have occurred within
the Agency that cannot reliably be predicted at the time of
notification.
For example, EPA could determine that applications requiring a
particular set of tiered data (ecological effects, for example)
routinely should require 4 months delay time for a new chemical, taking
into account the actual review time and the re-review time. Two years
later, when those studies are submitted to the Agency, EPA could be in
a situation where its workload has doubled or key personnel are not
available, leading to a likely delay time of 6 months.
EPA welcomes comment on how the ``delay time'' decision process
might be structured and administered for maximum efficiency and equity.
EPA is considering how and when negotiations on delay times are most
appropriately conducted. EPA solicits comment on criteria, timing, and
procedures that could be adopted and whether any of these should be
regulatory. Realistically, EPA believes that negotiation and agreement
on an Agency delay time can take place only at or close to the point of
resubmission. Further, EPA believes that negotiation procedures should
be informal and non-regulatory to offer the greatest flexibility, and
at this time is not proposing regulatory negotiation procedures. EPA
seeks comment on the following questions:
Criteria. What factors are most important in determining how long
delay time should be? The type of application? The nature of the
deficiency? The elapsed or remaining review period? Other priorities?
Timing. At what point would discussions between EPA and applicants
be most productive and least demanding of time and resources? Soon
after notification of deficiencies for planning purposes? Reasonably
close to the expected date of resubmission? Only after resubmission and
determination that the resubmission is complete?
Procedure. Should specific negotiation procedures be developed? Are
discussions likely to be a frequent occurrence? Should negotiation
procedures be developed on a case-by-case, as-needed basis? Are
informal procedures sufficient or is there a need for a regulatory
framework?
12. Denial for failure to submit required information (``not for
cause''). If EPA notifies an applicant of deficiencies, and agrees with
the applicant on a resubmission date for the application, and the
applicant fails, without good cause, to submit by that date, or fails
to submit a ``complete'' resubmission, EPA has the option of denying
the application. A denial of this type (a ``not for cause'' denial)
would not be for reasons of potential adverse effects (a ``for cause''
denial), but because the applicant has failed to submit the information
the Agency required to reach a decision on the application.
Several readings of FIFRA section 3(h)(3)(F)(i) are possible with
respect to a denial action the Agency may take as the endpoint of a
review period. EPA believes some interpretations, while plausible and
logical, would not likely achieve what we believe the Congress
intended. EPA is instead adopting an interpretation that we believe
both advances the goal of Congress that the Agency institute reforms to
improve the antimicrobial decision making process, and preserves the
rights of applicants under the statutory framework for denials under
FIFRA section 3(c)(6).
Under one possible reading of the statute, the Agency would review
the application under the review periods specified in proposed
Sec. 152.457, and within those same review periods take all the actions
required under FIFRA section 3(c)(6) for denials including a 30-day
notice of intent to deny prior to actual denial. This interpretation
would effectively shorten the review periods established by section
3(h) by 30 days, a result that would be particularly acute in the case
of short review periods such as those of 120 days or less. In
establishing the review periods, Congress considered the amounts of
time the Agency requires to review various types of applications. Each
review period goal was intended to provide a streamlined yet presumably
adequate amount of time for the Agency to review these applications.
Congress realized that in some instances these times would not be
adequate and allowed for the Agency and applicant to extend the
applicable review period through mutual agreement. We do not believe
that Congress would on the one hand acknowledge EPA's possible need to
extend review periods, while at the same time effectively diminishing
each review period to accommodate the correction period for FIFRA
section 3(c)(6) denials.
An equally plausible interpretation is that FIFRA section
3(h)(3)(F)(i) overrides the provisions of section 3(c)(6) altogether.
Under this interpretation, EPA would not have to issue a 30-day Notice
of Intent, or provide opportunity for a hearing. However, there is no
indication of Congressional intent to diminish the opportunity for an
applicant to remedy deficiencies and/or request a hearing for denials
of applications.
EPA believes a third interpretation is reasonable and more
appropriate. EPA would regard the Notice of Intent to Deny (NOID)
required by FIFRA section 3(c)(6) as the practical equivalent of a
denial under FIFRA section 3(h). At the point a decision is reached
under Sec. 152.457 (including any extended review periods), EPA would
commence the FIFRA section 3(c)(6) denial process by issuing a NOID.
Under this interpretation, the Agency would have the full review period
contemplated by Congress, and applicants would be afforded the
protections intended for FIFRA section 3(c)(6) denials. Accordingly,
proposed Sec. 152.455 would provide that the 30-day NOID itself
constitutes the denial decision required by section 3(h)(3).
Denial under FIFRA section 3(h)(3) would be the same as denial
under FIFRA section 3(c)(6). Legally, EPA would find that the applicant
has failed to meet the registration standard of section 3(c)(5), in
that ``its labeling and other material required to be submitted'' do
not ``comply with the requirements of the Act.'' EPA's determination to
deny an application would set in motion a process that entails the
NOID, opportunity for the applicant to correct the application
deficiencies within 30 days, final denial if deficiencies are not
corrected, and the opportunity for an administrative hearing process.
Denial procedures are found in Sec. 152.118.
EPA would be unlikely to allow additional time for correction
beyond the 30 days provided by the NOID, for several reasons. First,
EPA has already notified the applicant previously and agreed upon an
appropriate time for submitting additional data (of a long-term
nature). Additional discussion at this point would not seem justified
in light of the previous negotiations. Second, as noted earlier, EPA's
tracking system will be strained if EPA must repeatedly recompute the
elapsed review period due to extensions, new resubmission dates, or
additional EPA review times. EPA and applicants will not be well served
if tracking system needs overwhelm the review process. At some point,
EPA must reach closure on an application. Finally, there is the issue
of equity among applicants. Negotiating time for any application is
decreased review time for all applications, and should be allocated
evenly across applications rather than consumed on a single undeserving
application.
[[Page 50694]]
As an alternative, EPA could determine that the failure to resubmit
properly and on time renders the application incomplete. In either
case, the effect on the review clock is the same: it would start over
whenever the applicant submitted the complete data or properly
completed the application.
14. Denial for failure to meet the registration standard (``for
cause''). Finally, as already provided by the statute, EPA can
determine that an application should be denied because the pesticide or
its uses pose unreasonable adverse effects on man or the environment (a
``for cause'' denial). Legally, EPA would determine that it fails to
meet the registration standard of FIFRA section 3(c)(5)(C) or (D).
As in the case of a not-for-cause denial, EPA would follow the
denial procedures of FIFRA section 3(c)(6) and Sec. 152.118. Also as
noted above, EPA would treat the NOID as the decision required by FIFRA
section 3(h). EPA expects a denial for cause to be a rare occurrence.
H. Review Periods
1. Statutory provisions. Although FIFRA section 3(h) is premised
upon the establishment of decision-making deadlines, it does not
prescribe a specific set of review periods that EPA must adopt by
regulation, However, section 3(h) does contain two sets of review
periods that express Congressional intent in this area. EPA has given
careful consideration to each, discussed in this unit, and is today
proposing one.
First, section 3(h)(2) establishes review time period reduction
``goals,'' ranging from 90 days to 540 days, whose achievement is tied
to the implementation of the process reforms required by section
3(h)(1). Under section 3(h)(1), the explicit purpose of the process
reforms is to achieve the ``goal'' review periods. The statute stops
short of requiring that EPA adopt by regulation a set of statutorily-
mandated review periods. The statute appears to anticipate that EPA's
management reforms might take some time to fully implement to achieve
the goal review periods: section 3(h)(4) requires EPA to submit an
annual report to appropriate Congressional committees documenting its
progress toward the goals. Thus, while EPA is to work toward the goal
review periods, Congress did not require EPA to adopt the ``goal''
review periods in its regulation. EPA may include other review periods
in the regulation so long as it complies with other requirements
triggered if the goals are not met.
Congress did, however, intend that EPA should take the goal review
periods seriously, and therefore put in place two provisions that are
triggered if EPA does not meet the goal review periods. The annual
report mentioned above is to be submitted ``beginning on the date of
enactment of this subsection and ending on the date that the goals
under paragraph (2) [the goal review periods] are achieved.'' Thus, as
long as EPA is not meeting any statutory ``goal'' review periods, for
whatever reason, it must continue to report to Congress on its
progress. The first such annual report was issued in October 1997 (EPA
739-R-97-001).
Moreover, if EPA issues a final regulation that fails to meet any
of the goals, it also must comply with the requirements of section
3(h)(3)(B)(ii) by identifying in the final rule any unmet goal,
explaining why the goal was not met, describing the elements of the
regulations included instead, and identifying future steps to attain
the goal. Again, the statute does not require that EPA propose a
statutorily-identified set of regulatory review periods, though a
timeframe is required to be included in the regulation.
The second statement of Congressional intent, in section
3(h)(3)(D), establishes ``default'' review periods, ranging from 90
days to 2 years, that automatically took effect on April 25, 1998,
since EPA's final regulation was not effective by that date. The
``default'' review periods are equal to or longer than the ``goal''
review periods, depending upon the type of application. After
promulgation of this regulation, the default review periods will be
replaced by time periods specified in the final rule. In the
legislative history of the antimicrobial provisions, it is stated that
``maximum time periods for review are specified in Subtitle B for
various activities.'' [Subtitle B contains the amendments in FIFRA
section 3(h)]. Since the default review periods are in fact the
``maximum review periods specified'' in section 3(h), this language
could be read to suggest that Congress intended the default review
periods to be adopted by the Agency in its regulation. However, EPA
views the ``default'' review periods as a ``hammer'' provision to
encourage timely promulgation of its antimicrobial final rule
containing EPA-specified review periods, rather than a statement of
Congressional intent as to what review periods should be adopted.
2. EPA proposal. EPA is today proposing the ``goal'' review
periods. Since these are the benchmark of the management and process
reforms contemplated by Congress, EPA believes they are more
appropriate than any other review periods, which would of necessity
serve only in an interim capacity until the ``goal'' review periods
could be met. As an alternative, EPA could consider and would like
comment on the options of: adopting no review periods by regulation and
relying on administrative review periods; adopting the ``default''
review periods; or adopting some other review periods. Commenters who
support this last option should be specific as to the review periods
sought and why. If other than the goal review periods are ultimately
adopted, EPA would strive to meet the goal review periods, as it has
since FQPA was enacted.
Section 152.457 of today's proposal sets out EPA's proposed review
periods. The three tables in that section address, respectively,
approvals of new registrations, amended registrations, and ``qualifying
resubmissions.'' As noted in Unit VIII.D., EPA proposes to review an
application for a major new use within 270 days, regardless of whether
that application is a new registration or an amendment to an existing
registration. Accordingly the tables in Sec. 152.457(c) and (d) both
include ``major new use.'' Proposed Sec. 152.457 also sets out the
limitations of applicability of review periods.
3. Food use antimicrobial products. As defined by FIFRA section
2(mm), antimicrobial pesticides do not include products whose intended
use would require a clearance under the FFDCA. As noted in Unit VI.B.,
EPA intends to apply this exception so as to exclude only applications
that would require a new or revised clearance. Applications subject to
an existing clearance that does not need revision would be
antimicrobial pesticides.
4. Wood preservatives. The statutory definition also excludes
aquatic herbicides and some wood preservatives and antifoulants from
definition as ``antimicrobial pesticides.'' Applications for
registration of such products are not covered by subpart W and are not
eligible for the review periods of Sec. 152.457.
However, under FIFRA section 3(h)(3)(E), applications for wood
preservatives (and only wood preservatives) are eligible for the
statutorily-required review periods that would be established by this
proposal if they meet certain conditions:
First, the application must be for a wood preservative
that bears an antimicrobial claim as defined in FIFRA section 2(mm),
even if other non-antimicrobial wood preservative claims (such as
fungus or insect protection) are made.
Second, the data requirements to support the wood
preservative product
[[Page 50695]]
that is not an ``antimicrobial pesticide'' must be the same as the data
requirements that support a wood preservative that is an
``antimicrobial pesticide.'' In general, the data requirements in part
158 are the same for all wood preservatives, regardless of the type of
wood preservative claim made. Thus, all wood preservative products
fulfill this criterion.
Finally, the applicability of the statutorily-required
review period to a wood preservative application is to be ``consistent
with the degree of risk posed by the use of the wood preservative.''
EPA interprets this clause to permit the Agency, in its discretion and
on a case-by-case basis, to determine that an individual wood
preservative application is not subject to the statutorily-required
review period based on risk concerns.
For example, EPA might exercise this discretion for an application
that initially would have a review period of 180 days. During the
review, however, EPA discovers that the wood preservative use poses
significantly greater risks than a typical ``substantive new use''
application. This might occur if the treated wood were intended for use
in a manner that greatly increased or changed the exposure potential to
humans or other species. To evaluate the increased risk, EPA might need
more than 180 days, even if substantial new data were not required. In
this situation, EPA would notify the wood preservative applicant that
the application was no longer entitled to a statutorily-required review
period, and specify the risk reasons therefor.
EPA would make every effort in its notification to estimate when
the application review would be completed, although the application
would no longer qualify for review period coverage. EPA regards its
notification to the wood preservative applicant of a risk differential
basis for review as relieving EPA of its obligation to complete review
within any statutorily-required review period.
5. Fast-track applications. Fast-track applications are described
in FIFRA section 3(c)(3). Fast-track applications are not limited to
antimicrobial products, and EPA is required to reach a decision on the
application within 90 days. Currently, there are no regulations for
fast-track applications, and none are needed because the statute sets
out clear deadlines for completion of review. The review period for an
antimicrobial pesticide specifically does not affect or substitute for
the timeframe for a fast-track review of an antimicrobial pesticide.
Generally, antimicrobial applications for identical or substantially
similar new products or minor amendments are equivalent to fast-track
applications, and would be decided under either provision within 90
days.
As a legal matter, however, an application must be reviewed either
as a fast-track application or an antimicrobial application--a single
application cannot be both. EPA interprets FIFRA section
3(h)(3)(F)(iii) to place an application that could qualify as either a
``fast-track'' or ``antimicrobial pesticide'' application squarely
under the antimicrobial provisions and review periods. While there are
minor procedural differences between 90-day fast-track decisions and
90-day antimicrobial review period decisions, the significant
difference between the two is that a fast-track action is not
judicially reviewable if EPA fails to render its decision within 90
days while an antimicrobial action is judicially reviewable.
IX. Duration of Registration for Products Bearing Public Health
Claims
EPA proposes in Sec. 152.458 to establish terms for a time-limited
registration of products bearing a public health claim. The term of a
registration would be limited to no more than 5 years. The registration
could be continued only if the registrant conducts product analysis and
efficacy testing that confirms that the product continues to meet the
applicable registration standards of FIFRA section 3(c)(5). EPA
believes that it is authorized to establish this provision under the
authority of sections 3(h) and 25(a).
A. Statutory Requirements
FIFRA section 3(h)(3)(A)(ii)(IV) mandates two things: (1) that EPA
``. . . ensure that the registration process is sufficient to maintain
antimicrobial pesticide efficacy''; and (2) that ``antimicrobial
pesticide products continue to meet product performance standards and
effectiveness levels for each type of label claim made.'' Section 3(h)
focuses on the registration process as a means of ensuring continued
product performance. More important, however, is the strong
Congressional directive to ensure continued product performance and
effectiveness after registration. Thus, under section 3(h), EPA must
address post-registration efficacy in the antimicrobial regulation
proposed today.
EPA is also authorized under FIFRA section 25(a) to issue
regulations to carry out the provisions of the Act. Such regulations
must specifically ``take into account the difference in concept and
usage between various classes of pesticides, including public health
pesticides and differences in environmental risk and the appropriate
data for evaluating such risk between agricultural, nonagricultural,
and public health pesticides.'' ``Public health pesticide'' is defined
in FIFRA section 2(nn) to include, among other things, pesticide
products intended for use against ``viruses, bacteria, or other
microorganisms . . . that pose a threat to public health.'' The
references in FIFRA section 25(a) singling out public health pesticides
were added by FQPA, and EPA regards their addition as expressing
Congressional intent that public health pesticides as a class should be
distinguished from other pesticides when considering regulatory
requirements, including this proposal.
Taken together, EPA believes that the clear Congressional intent
expressed in section 3(h) to ensure post-registration product
performance and effectiveness, coupled with the authority conferred by
section 25(a), authorize EPA to establish by regulation binding
requirements on registrants of antimicrobial public health products to
ensure continued product efficacy. The requirements relate to initial
registration and also extend into post-registration activities.
B. Alternatives Considered
As noted in Unit IV.E., EPA has relied on enforcement mechanisms to
ensure post-registration efficacy; EPA will continue to use these as
appropriate. But, because failure of an antimicrobial public health
product to work as intended cannot normally be detected by the user and
can have serious health and safety consequences or other unreasonable
adverse effects, it is critical that EPA use all available regulatory
and enforcement mechanisms to ensure public health protection.
One means of ensuring continued efficacy after registration would
be through the statutorily required re-review of products. FIFRA
contains two provisions that require EPA to reassess each registration
according to the latest scientific standards, which for public health
products would include an efficacy review. FIFRA section 4 requires a
one-time reregistration of each product first registered before
November 1984. This process is underway, but to date few antimicrobial
products have been reviewed under section 4, and products registered
since 1984 are not subject to reregistration. Additionally, FIFRA
section 3(g) requires EPA to periodically review each registration,
with a goal of re-reviewing each product every 15 years.
[[Page 50696]]
Although these provisions will be useful in ensuring that pesticide
products continue to meet the registration standard, based upon up-to-
date scientific standards, EPA believes that more product oversight is
needed to meet the mandate of FIFRA section 3(h) to ensure continued
efficacy of antimicrobial public health products. Neither a one-time
re-review nor a periodic review only every 15 years offers adequate
assurance of continued efficacy of products so critical to public
health protection. EPA believes that by requiring the re-testing of
products at more frequent intervals than every 15 years, complemented
by EPA, State and other testing programs, it can be better assured of
continued product efficacy, without incurring to itself or imposing
upon registrants significant additional costs.
Alternatively, EPA could establish, or require registrants to
establish, an ongoing quality control and efficacy monitoring program
to evaluate product composition and efficacy on a frequent basis. EPA
conducted a one-time testing of sterilant products, and is conducting
similar testing of hospital disinfectant products. EPA believes that
many antimicrobial registrants, fully aware of the need for continuing
quality control and efficacy, already test their products on a routine
basis, although EPA currently has no data on the number of producers
who do so, the type of testing conducted, or how frequently it is done.
A formalized testing program, whether by EPA or registrants, would
obviously be one way to meet the mandate of FIFRA section 3(h), and, if
conducted at frequent intervals, would offer the greatest assurance of
continued product performance and public health protection. EPA itself
does not have the resources to establish and sustain such a program,
and so EPA proposes that registrants bear the cost of such testing. Two
approaches have been considered, and one is being proposed today.
One such method would be to require that a public health applicant
develop and submit for Agency approval as part of his/her application
for registration or reregistration a plan for continuous quality
control and efficacy testing. Such a requirement would meet the mandate
of using the registration process to ensure efficacy, as well as
ensuring continued post-registration needs. Upon approval of the
registration or reregistration, the plan would become a term of the
registration and would be binding on the registrant. The benefit of
this approach is that public health applicants would be afforded the
greatest flexibility to design a program that they believe satisfies
the needs of the Agency. However, approval of a plan would require
greater review resources for the Agency, and potentially lead to delays
in approval beyond the established review periods required by
Sec. 152.458. Comments are requested as to the value, feasibility, and
potential costs of such a requirement, as well as criteria for
evaluating plans. EPA is not proposing this option today, but could
adopt it in the final rule. If EPA does so, it would include the
requirement for a public health quality control and efficacy monitoring
plan in Sec. 152.450.
EPA seeks information on current registrant- or producer-imposed
quality control measures, whether producers are currently routinely
conducting efficacy testing on a batch basis or at frequent intervals,
and what type of testing is conducted. Finally, comments are solicited
on any additional ways of ensuring continued efficacy of public health
products; suggestions would be considered for future implementation,
either administratively or by regulation.
C. Sunset Provision
1. Maximum 5-year registration term. EPA proposes to implement a
periodic and regular testing program by limiting the duration of a new
antimicrobial public health registration to no more than 5 years from
the date of initial registration of the new product. EPA would
incorporate the 5-year expiration into the approval of the application
as a term of registration. Every 5 years, in order to avoid expiration,
the registrant would have to conduct the testing described in
Sec. 152.458(b)(3) and certify that the product has passed the tests.
The Agency is also proposing to require testing every 5 years as a
prerequisite for maintaining the registrations of existing products,
i.e., products registered as of the effective date of the rule. For
existing products, the 5-year period would begin on the earliest of:
(1) The date of first amendment after the effective date; (2) the date
of reregistration under FIFRA section 4; or (3) a date certain
approximately 6 months after the effective date of the rule. EPA would
in the final rule specify the date certain, which, based on current
projected schedules, would be no earlier than August 1, 2000. This last
date would ensure that all products registered at the time the rule
becomes effective would be brought into the retesting scheme. EPA
expects that this default date would govern for most existing products,
since the number of amendments and reregistrations that could be
expected in the 6-month period is unlikely to approach the number of
public health registrations (currently estimated at approximately 3,000
products).
In the case of an amendment or reregistration, EPA approval letters
would include the 5-year requirement. Because there would otherwise be
no Agency notification for products that become subject on the specific
default date, EPA would notify all such registrants of the effective
date.
EPA is proposing this phased introduction of the testing
requirement for existing products because it believes that phased
testing will create less strain upon laboratory demand for testing and
upon Agency resources. It would, however, complicate the tracking of
expiration dates.
As an alternative, EPA could begin the 5-year retesting requirement
on a single date for all existing products. While this would ensure
equity for existing products and simplify calculation of expiration
dates for both registrants and the Agency, it could lead to high demand
for laboratory testing on a compressed schedule every 5 years. Even
with a single date for existing products, new products would become
subject to the retesting requirement on a phased basis as they are
registered; thus, there would always be some phasing of the retesting
requirement. Over time, as new products are registered and existing
ones taken off the market, the phased testing scheme would become the
norm rather than the exception. If EPA were to adopt a single date, it
would specify the date in the final rule.
In any case, the scope of EPA's determination of continued
registrability at the 5-year intervals would be limited to the
composition and efficacy standards in FIFRA section 3(c)(5)(A) and (C),
i.e., that the product's composition ``is such as to warrant the
proposed claims for it,'' and that ``it will perform its intended
function [without unreasonable adverse effects on the environment].''
EPA's evaluation would be limited to products bearing public health
claims and its determination to whether the product would perform its
intended function at the antimicrobial levels claimed. EPA would not
expect to reevaluate the potential adverse effects of the product every
5 years, but generally would reserve such evaluation for a 15-year
review cycle. Thus, in any given 15-year period, EPA typically would
review each product once under the 15-year statutory review provision
and 3 times for efficacy purposes. Notwithstanding these scheduled
review intervals, EPA may conduct a review of a product for any purpose
(including, but not limited to, efficacy
[[Page 50697]]
concerns) at any time and take regulatory or enforcement action based
upon its findings.
EPA believes that a quality control check and efficacy evaluation
at least every 5 years is needed to ensure continued efficacy. However,
the Agency solicits comment as to whether a different registration term
should be implemented, either more or less than 5 years.
2. Data requirements. To meet the product composition standard,
proposed Sec. 152.458 would require a chemical analysis demonstrating
that the product conforms to the composition approved by EPA on the
most recent Statement of Formula, conducted according to the analytical
method that the registrant is required to provide the Agency under 40
CFR 158.180.
To meet the product efficacy standard, proposed Sec. 152.458 would
require that the registrant conduct the battery of efficacy tests that
would be required to support the product if it were submitted for new
registration at that time, conducted in accordance with the most
current Agency testing guidelines. Testing guidelines for antimicrobial
products are evolving, and testing would have to reflect the methods
and standards recognized by EPA at the time of the required testing.
To ensure that the testing reflected the product as distributed and
sold at the 5-year mark, the testing would have to be conducted during
the final year of the 5-year registration period (or other renewal
period if 5 years is not selected). Although EPA believes it is in the
interest of registrants to conduct such analysis and testing more
frequently as a matter of good business practice, only testing
conducted within the last year could be used to support renewal of
product registration.
3. Certification procedure for compliance. EPA believes that it can
accomplish this limited renewal program and monitor compliance without
routinely reviewing the actual test results. In accordance with the
mandate of FIFRA section 3(h)(3)(B)(iii) to ``consider the
establishment of a certification process for regulatory actions
involving risks that can be responsibly managed . . . in the most cost-
efficient manner,'' EPA proposes to use a certification process as the
most cost-effective means of administering the program. Each registrant
would certify in writing to the Agency that the testing had been
conducted as required in accordance with EPA Good Laboratory Practice
Standards, and that the results demonstrate that the product meets the
composition and efficacy standards specified. The certification must be
signed by an authorized representative of the registrant. As a
condition of registration, EPA would require that test results be made
available immediately to EPA upon request; EPA expects that it would
selectively review the data for some products.
The required certification would have to be submitted to the Office
of Pesticide Programs no later than 90 days prior to each successive
expiration date of the registration, to allow sufficient time for EPA
to process it and notify the registrant of its determination. If at any
time after the renewal, the Agency determined that the certification
was false or the data upon which it was based do not support the
certification for any reason, the registration would be subject to
regulatory or enforcement action or both.
4. Failure to submit. EPA would not notify registrants of the
upcoming expiration of their product registrations. Registrants would
be responsible for monitoring the status of their registrations,
conducting the testing and submitting the required certification in a
timely manner. Failure to submit would result in the expiration of the
registration automatically and without hearing rights. If the
registration expired, the registrant would have to submit a new
application for registration to once again market the product.
If EPA has no other information or data to suggest that the product
is no longer efficacious, EPA would permit the registrant 90 days to
distribute and sell his/her existing stocks of product (product in
existence on or before the date of registration expiration). Product
already distributed by the registrant and in channels of trade could be
distributed and sold for 1 year after expiration.
5. Products that fail efficacy testing. If a product fails efficacy
testing at its 5-year renewal, the registrant would be unable to
certify as required by Sec. 152.458, and the product registration would
expire at its 5-year anniversary.
Moreover, there is a continuing obligation under FIFRA section
6(a)(2) to report information concerning adverse effects to the Agency.
In certain cases this obligation extends beyond the life of the
registration (for example, to an expired registration). If the
registrant conducts efficacy testing at any time, and the product fails
to meet the performance standard of part 156, subpart W, for each
public health claim, the registrant is required to report such failure
to EPA in accordance with the procedures and timeframes in 40 CFR part
159. Section 159.188 specifically details the information required to
be submitted concerning antimicrobial public health products. The
requirement to submit under FIFRA section 6(a)(2) and the regulations
in 40 CFR part 159 is a separate requirement from that under this
proposal.
X. General Conditions of Registration
EPA proposes in Sec. 152.459 to establish conditions of
registration for antimicrobial pesticides. Under FIFRA section 3(c)(7),
EPA is authorized to register pesticide products conditionally. Current
regulations in Sec. 152.115 implement EPA's authority, and specify
general conditions applicable to registrations. Section 152.115(c)
permits EPA to establish, on a case-by-case basis, other conditions
applicable to registration under FIFRA section 3(c)(7).
For antimicrobial pesticides, EPA proposes in Sec. 152.459(a) to
cross-reference the conditions of Sec. 152.115. These conditions relate
primarily to submission of missing data subsequent to registration.
Further, EPA proposes to establish as a condition of registration a
requirement that registrants of non-public health products submit
efficacy data upon request by the Agency. Registrants are currently
required to maintain efficacy data for non-public health products, but
EPA does not routinely review them as part of the application. Upon
request, registrants are required to submit the data. When this request
is made prior to approval of a new application, EPA can refuse to
register the product if the registrant does not comply. EPA proposes in
Sec. 152.459(b) to establish as a condition of registration that
registrants must submit upon request any efficacy data for a non-public
health product that were not required to be submitted with the
application. By establishing submission as a condition of registration,
EPA makes explicit the authority and action it will take (expedited
cancellation under FIFRA section 6(e)) if registrants fail to provide
these data after registration.
XI. EPA/FDA Jurisdiction Over Antimicrobial Products Used in or on
Food
A. Background
Since EPA was created in 1970, EPA and FDA have shared authority
under FFDCA over pesticide residues in food. Prior to FQPA, the
division of jurisdiction between EPA and FDA was governed by a number
of somewhat complicated provisions of FFDCA. FQPA modified the FFDCA to
create much clearer lines of jurisdiction. In the
[[Page 50698]]
process, FQPA transferred to EPA regulatory responsibility for a number
of antimicrobial substances which for many years had been under FDA
jurisdiction.
In the 2 years after FQPA enactment, EPA and FDA held extensive
discussions on their respective legal authorities pre- and post-FQPA.
The two agencies issued a joint Federal Register notice entitled
``Legal and Policy Interpretation of the Jurisdiction under the Federal
Food, Drug, and Cosmetic Act of the Food and Drug Administration and
the Environmental Protection Agency over the use of Antimicrobial
Substances with the Potential to Become Components of Food''
[hereinafter ``Policy Interpretation''] issued in the Federal Register
on October 9, 1998 (63 FR 54532) (FRL-5773-8). In that notice EPA and
FDA discussed a proposed allocation of jurisdiction over antimicrobial
substances which would transfer back to FDA regulatory authority over
many of the substances that had been transferred to EPA in 1996 by
FQPA.
EPA would have effected the transfer in a subsequent regulation by
revising its declaration of a FIFRA ``pest'' in Sec. 152.5 to exclude
certain microorganisms occurring in food processing facilities,
packaging and food contact articles. Readers are referred to the Policy
Interpretation for a full discussion of the proposed approach.
B. FDA Regains FFDCA Jurisdiction
On October 30, 1998, however, Congress passed the ``Antimicrobial
Regulation Technical Corrections Act of 1998'' (ARTCA), Public L. 105-
324, which amended FFDCA section 201(q)(1) and 408(j) in a manner that
essentially accomplished the two Agencies' planned regulatory approach,
and obviated the need for EPA to issue regulations. ARTCA supersedes
the Policy Interpretation with respect to FFDCA regulatory authority
over antimicrobial residues in food except for residues of ethylene and
propylene oxides, which were retained as ``pesticides.'' ARTCA,
however, does not address the interpretation of the FIFRA term
``processed food'' that was included in the Policy Interpretation.
C. EPA Retains FIFRA Jurisdiction
Under the Policy Interpretation, EPA intended to propose to yield
both FFDCA and FIFRA authority over those antimicrobial substances
addressed in the Policy Interpretation. EPA and FDA viewed the
regulatory approach of redefining FIFRA ``pests'' to be the best means
of accomplishing the transfer agreed upon between the Agencies. No
authority under FFDCA would have achieved this objective before passage
of ARTCA.
Unlike the proposed change discussed in the Policy Interpretation,
however, the statutory change put in place by ARTCA affects only FFDCA
authority over antimicrobial residues in food. ARTCA does not affect
the status of any substance as a ``pesticide'' within the meaning of
FIFRA. The legislative history of ARTCA makes this point clear:
This amendment would affect the regulation of antimicrobial
pesticides only under the FFDCA. EPA would continue to regulate
antimicrobial pesticides under FIFRA, and EPA's authorities under
that statute would not be changed.
In light of ARTCA, which provides specific Congressional direction,
EPA is not proposing to exclude or exempt these products from FIFRA
requirements, as discussed in the Policy Interpretation.
Because the legislation is complex, EPA has developed an overview
table of current FFDCA authority post-ARTCA. Table 4 below is an
overview of antimicrobial substances whose use may result in residues
in food. Column 1 lists the category of antimicrobial substances.
Column 2 further subdivides the major categories. Column 3 gives the
current jurisdiction under FFDCA over antimicrobial substances after
ARTCA. Note that, even where FFDCA authority is vested in FDA, EPA
retains FIFRA authority for antimicrobial products other than those
used on processed food. Such products will continue to require
registration.
Table 4.--Jurisdiction Under FFDCA Over Residues of Antimicrobial
Substances in or on Fooda
------------------------------------------------------------------------
Currect
Use Sites/Categories Subcategories, if Jurisdiction under
Applicable FFDCA
------------------------------------------------------------------------
1. Edible raw agricultural a. Pre- and post- EPA
commodities harvest field use
on crops
---------------------------------------
b. In a food FDA
processing
facilityb
---------------------------------------
c. Consumer use EPA
(e.g., home
gardens)
------------------------------------------------------------------------
2. Process water that contacts a. Post-harvest EPA
edible food field treatmentc
of raw
agricultural
commodities
---------------------------------------
b. In a food FDA
processing
facilityb
---------------------------------------
c. Consumer use EPA
(e.g., home
produce washes
for raw
agricultural
commodities)
------------------------------------------------------------------------
3. Edible processed food All uses FDA
------------------------------------------------------------------------
4. Animal drinking water Uses other than EPA
animal drugs
------------------------------------------------------------------------
5. Permanent or semi-permanent All sites, EPA
food-contact surfaces including food
processing
facilitiesb
------------------------------------------------------------------------
6. Production of food packaging All, regardless of FDA
materials and in or on finished whether the food
materials, including plastic, to be packaged is
paper, and paperboard a raw or
processed food
------------------------------------------------------------------------
7. Production of food-contact a. No intended FDA
articles, other than food antimicrobial
packaging effect in the
finished article;
any ongoing
effect is not an
effect on the
surface of the
article
---------------------------------------
[[Page 50699]]
b. An intended EPA
ongoing
antimicrobial
effect on the
surface of the
finished article
------------------------------------------------------------------------
aThe term ``food'' is defined according to FFDCA section 201(f).
bEPA has used this term for convenience in this overview table. FFDCA
section 2(q)(1)(B) describes the scope of activities to include
``locations where food is prepared, packed, or held for commercial
purposes.''
cEPA has used this term for convenience in this overview table. FFDCA
section 2(q)(1)(B) describes the scope of these treatments to include:
(1) treatments in facilities where the treatment does not change the
raw agricultural status of the food; and (2) treatments applied during
transportation between the field and the treatment facility.
XII. Efficacy Performance and Labeling Standards for Antimicrobial
Products
EPA proposes to create a new Subpart W (Secs. 156.440 through
156.458) in part 156, entitled Public Health Claims for Antimicrobial
Pesticides. Subpart W would establish labeling requirements for
antimicrobial pesticides that make public health claims based upon the
level and type of efficacy demonstrated by testing. The efficacy
performance standards upon which the proposed requirements are based
are derived from the testing requirements of 40 CFR part 158, and the
test methods and standards provided in Subdivision G of the Pesticide
Assessment Guidelines. Today's proposal would also codify certain
labeling requirements that are currently applied to antimicrobial
pesticides individually at the time of registration, but are contained
only in Guidelines (Subdivision H of the Pesticide Guidelines). Neither
the performance standards nor the labeling requirements are a departure
from current and longstanding policies.
A. Need for Rule
EPA bears a special responsibility to ensure that antimicrobial
efficacy for public health products be substantiated and maintained
over the life of the product because of the potentially serious
consequences of lack of efficacy, and the fact that users cannot
independently ascertain product efficacy. For that reason, EPA not only
must review antimicrobial efficacy data to ensure that products indeed
perform at the claimed level of antimicrobial activity, but also must
assure that product labeling accurately expresses the type and level of
activity to be expected. Effective control of public health pests is
not only a function of the availability of products that work as
intended, but also of users' ability to select an appropriate product
for their needs, and to use it properly. The product labeling is
critical in conveying this information. By issuing performance
standards and associated labeling standards as rules rather than the
current Guidelines, EPA expects to ensure consistency in labeling,
promote a common understanding among registrants and the user community
of performance expectations and limitations, and thereby maintain the
benefits of these products in protecting public health.
B. 1984 Proposal
EPA originally proposed these performance and labeling standards in
substantially similar form in 1984 as part of a larger general
pesticide labeling proposal (September 26, 1984, 49 FR 37959), but did
not finalize them. Because of the intervening time, EPA is reproposing
those efficacy performance and labeling standards today. In response to
the 1984 proposal, EPA received eight comments pertaining to the
efficacy performance and labeling standards. The commenters included
two trade associations (the Chemical Specialties Manufacturers'
Association and the International Sanitary Supply Association), and six
individual producers of antimicrobial pesticides. A copy of these
comments or a summary is available in the public docket. EPA has not
reviewed these comments in detail for this new proposal, and invites
commenters to reiterate any comments they believe are relevant to this
proposal.
C. Current Proposal
Every pesticide product must be properly labeled, in accordance
with general labeling requirements of part 156, including, among other
things, use directions that describe the site of application, the
target pests associated with each site, the dosage rate, the method of
application, the frequency and timing of application and any particular
limitations on use. Antimicrobial products covered by subpart W must
comply with part 156 labeling requirements. In addition, for public
health antimicrobial products, the labeling must identify the type and
level of antimicrobial activity demonstrated by efficacy testing. A
product that does not meet the applicable performance standard of
proposed subpart W for a specified level of activity (such as
sterilizer, disinfectant, or sanitizer) or type of activity
(tuberculocidal, virucidal) may not be identified as such on the label,
and, in some cases, will be required to bear a disclaimer to make clear
the limitations of product performance.
Under proposed Sec. 156.440, the applicability of subpart W to
antimicrobial products is the same as that in part 152, subpart W. This
will clarify that all antimicrobial public health products, not just
those meeting the definition of ``antimicrobial pesticide,'' are
subject to the efficacy performance and labeling standards. This
clarifies the status of food use antimicrobials, which are excluded
from the statutory definition, but covered under EPA's proposed rule.
However, proposed Sec. 156.440 would limit applicability of subpart
W to end use products. EPA does not expect manufacturing use products
to make specific public health claims. Typically a manufacturing use
product must be supported by presumptive efficacy testing demonstrating
that the active ingredients are capable of antimicrobial activity. The
labeling typically bears information on the results of these screening
or presumptive efficacy tests. End use products must, however, be
supported by specific efficacy data on the end use formulation, on the
sites and under the expected conditions of use of the product itself.
The performance standards on which the labeling standards of subpart W
rely are based upon end use product testing, not presumptive testing of
manufacturing use products. The labeling statements and limitations
therefore would also relate only to end use products.
Proposed Sec. 156.441 contains pertinent definitions, including the
levels of antimicrobial activity that are permitted on labeling (e.g.,
sterilizer, disinfectant, sanitizer). This listing is not necessarily
exhaustive; in the future, EPA may define additional categories of
antimicrobial activity or public health pesticides.
Proposed Sec. 156.443 describes what types of claims EPA considers
to be public health claims. In general, public
[[Page 50700]]
health claims encompass three types of claims: (1) Claims of control of
specific microorganisms that are pathogenic to man; (2) claims of
levels of antimicrobial activity that are associated with public health
protection (e.g., disinfect), even if specific organisms are not named;
and (3) claims that make non-specific assertions relating to impact on
public health or safety, e.g., ``provides a germ-free environment.''
The use of such terms on a product label is deemed to bring a product
within the ambit of FIFRA regulation as a public health product.
Among the last, EPA has specifically included reference to the term
``sanitary'' as an antimicrobial public health claim. EPA believes that
this is a logical extension of the term ``sanitize,'' that should be
considered to bring a product under FIFRA regulation as a public health
pesticide. EPA regards a product that claims to ``create a sanitary
environment'' or is intended to achieve ``sanitary'' effects beyond
itself to be making an assertion of impact on public health. The
presence of such a claim would clearly constitute a pesticide claim.
At the same time, EPA recognizes that the term ``sanitary'' may be
used on a product in the more traditional sense of ``hygienic,'' i.e.,
to convey the fact that the product is clean or has been treated to
render it free of harmful organisms (for example, ``sanitary''
napkins). When used in such a sense, EPA believes that there is no
intent or claim that the product will have an antimicrobial function
beyond protection of itself. In the absence of an express claim, EPA
proposes to consider the claim ``sanitary'' as an implied pesticide
public health claim, and the product on which it appears as a pesticide
subject to FIFRA, if: (1) The product composition is similar to other
products registered under FIFRA that make antimicrobial claims; or (2)
the product contains a substance that is capable of antimicrobial
activity at the levels in the product and there is no other functional
reason for the ingredient to be present in the product. The burden
would be on the producer of a product that makes a ``sanitary'' claim
to demonstrate that the claim is not a public health claim. EPA seeks
comment as to whether its interpretation of ``sanitary'' claims is
sufficiently clear to unambiguously delineate pesticide products or
whether it could be overly broad and draw inappropriate products under
FIFRA.
Proposed Sec. 156.444 lists examples of specific antimicrobial-
related claims that EPA considers to be unacceptable because they are
misleading. These are an extension and clarification of existing
prohibitions against false and misleading statements found in
Sec. 156.10(a)(5). Again, the listings are intended to be exemplary;
EPA may determine on a case-by-case basis that a label statement or
claim is misleading.
A product that bears a public health claim, but which does not meet
the performance standard for that claim in subpart W would be
considered misbranded under FIFRA section 12(a)(1)(E). Registrants have
been on notice of the unacceptability of these statements from previous
and current Agency guidelines and policies. On the effective date of
the final rule, EPA would prohibit these claims from appearing on new
products. To ensure that all registrants of current produts are
provided adequate notice and have ample opportunity to evaluate their
label statements and delete or modify those that are unacceptable, EPA
proposes to permit registrants a 1 year period in which to modify
labeling before the Agency would find the products to be misbranded. As
of a date approximately 1 year after the effective date of the rule,
the actual date to be specified in the final rule, EPA may take action
against any product that it determines is misbranded based upon the
criteria in proposed Sec. 156.444. EPA requests comments on whether a 1
year period for label compliance is adequate. Based on comments, EPA
may in the final rule adopt a compliance date of more or less than 1
year.
The remainder of subpart W (Secs. 156.445 through 156.458)
describes the performance standards and acceptable claims that may be
made for various antimicrobial public health pesticides. Each section
generally contains the following:
1. The performance standard for a level of antimicrobial efficacy
on a specified site (e.g., sanitizing claim on hard surfaces) or,
alternatively, a description of a use site and the performance
standards that apply (e.g., fabrics and textiles, air sanitizers).
2. A reference to the appropriate Guideline for an acceptable test
protocol. The performance standards are based upon testing in
accordance with the test methods of the Pesticide Assessment
Guidelines, Subdivision G, or ``its equivalent.''
The term ``equivalent'' is defined in Sec. 156.441 to mean a
protocol or method that accomplishes the purposes of the cited
Guidelines, and that provides data equal in quality and completeness
for EPA assessment as that of the cited Guideline. With respect to
antimicrobial protocols, an equivalent protocol or method must be
validated by multiple laboratories studies that demonstrate
equivalency. The term ``Guidelines'' is defined to include both the
Pesticide Assessment Guidelines, Subdivision G, and the OPPTS
Harmonized Guidelines. For antimicrobial efficacy testing, these differ
only in the numbering and formatting of the Guidelines. Ultimately, the
OPPTS Guidelines are intended to supersede the OPP Guidelines. EPA
expects the Harmonized Guidelines to be issued before the rule is
promulgated. Therefore, in proposed subpart W we have included
references only to those updated Guidelines. A copy of the latest draft
of the Harmonized Guidelines for Antimicrobial Performance (810 series)
is included in the public docket. If the Harmonized Guidelines are not
final and available at the time of promulgation, EPA will substitute
references to the existing Pesticide Assessment Guidelines in the final
rule.
3. A statement of the acceptable claim(s) that may be made on
labeling of a product that meets the performance standard. Typically,
explicit terminology or wording is provided, which must be used to
ensure uniformity of claims. In this respect, Sec. 156.442 would
clarify that EPA requirements for specific terminology also authorize
grammatical variations on that terminology, or its use in statements
and phrases. For example, when EPA specifies that an acceptable claim
is as a ``tuberculocide,'' a product would be permitted to use the term
``tuberculocidal'' in a statement or phrase describing the activity of
the product.
4. Any restrictions or limitations upon use of the claim. For
example, proposed Sec. 156.455 states that an air sanitizer must bear a
statement that accurately describes the limited nature of the
sanitizing claim.
5. In some cases, a description of unacceptable claims. Generally,
both restrictions on claims and unacceptable claims are needed to
ensure that users, who may have broader expectations of efficacy than
the product demonstrates and the labeling conveys, are fully informed
of product limitations. For example, proposed Sec. 156.455 specifies
that an air sanitizer may not make claims as a sterilant, disinfectant
or germicide.
Proposed subpart W does not contain all required use directions for
antimicrobial public health products. It contains only the specific
performance standards and closely related restrictions and limitations
on labeling claims derived from those standards. Adequate use
directions for achieving expected efficacy require detailed
instructions that vary depending on the type of product, use site and
target
[[Page 50701]]
organism, and must be determined on a case-by-case basis. Particularly
for antimicrobial pesticides, use instructions must reflect very
specific test parameters keyed to sites of use. For example, the
presence of soil or moisture on a surface may affect the ability of a
product to perform, and must be accounted for both in efficacy testing
and in labeling use directions. These more detailed use instructions
are contained in Subdivision H, Labeling Requirements for Pesticide Use
Directions, Antimicrobial Products.
XIII. Other Labeling Revisions
A. Use Dilution Labeling
FIFRA section 3(c)(9)(D) provides that antimicrobial products that
are or may be diluted for use may bear a different ``statement of
caution or protective measures'' for the recommended diluted solution
than for the concentrate, provided that adequate data have been
submitted to support the proposed statement and the label provides
adequate protection for exposure to the diluted solution of the
pesticide. The Agency has developed policy and procedural guidance
pertaining to use dilution labeling, and will apply the policy to all
pesticide products, not just antimicrobial products as required by
FIFRA. Today's proposal would modify current regulations in part 156 to
provide specifically for use dilution labeling.
1. Data requirements. EPA intends to specify in a future part 158
proposal the data required to support use dilution labeling for
antimicrobial products.
The data needed to support use dilution labeling changes consist of
data on acute toxicity of the diluted product. If a product is diluted
with water, systemic toxicity (acute oral or dermal toxicity)
categorization can be supported by calculations from the concentrated
product. In general, systemic toxicity categories differ by a factor of
10. Therefore, in most cases, if dilutions are an order of magnitude or
more, the toxicity category for a particular route of exposure can be
expected to be the next lower category (Category I is highest). For
example, if the concentrated product toxicity category is II and the
product as used is diluted at least 10-fold, the diluted product should
be in toxicity category III; if it is diluted more than 100-fold, the
diluted product should be in toxicity category IV.
On the other hand, label statements triggered by skin or eye
irritation or dermal sensitization must be supported by new or cited
studies. Calculations are not acceptable because irritation and
sensitization effects do not necessarily correlate directly with the
degree of dilution.
In some cases, a diluted product may be more irritating than the
concentrated product. Data may be cited if another registered product
(such as a ready to use formulation) with a composition similar to the
diluted product is supported by acceptable data. In all cases in which
the diluent is other than water, data must be submitted, since diluents
other than water may themselves be toxic.
2. Permitted use dilution labeling. EPA proposes to expand its
current labeling regulations in 40 CFR part 156 to address
opportunities for use dilution labeling. Currently Sec. 156.10 requires
that a product be labeled with information on the product as
distributed and sold. The product that is marketed to users may be a
concentrate product with directions for use dilution, or may be a
ready-to-use product requiring no dilution. In many cases, a
concentrate product as diluted will be substantially similar in
composition and hazards to a ready-to-use product. It makes sense,
then, that registrants should be permitted to provide additional
information on precautions and protective measures for the diluted
product. At the same time, the addition of statements appropriate for
the product as diluted should not be allowed to detract from or mislead
the user as to the hazards of the product in its undiluted form.
EPA believes that the ``statement of caution or protective
measures'' referred to in FIFRA section 3(c)(9)(D) includes the first
aid or practical treatment statement, the human (and animal)
precautionary statements, and various personal protective equipment
statements. EPA believes that a ``statement of caution'' does not
extend to the signal word (DANGER, WARNING, or CAUTION), word POISON
and skull and crossbones, or child hazard warning (``Keep Out of Reach
of Children''), which should reflect and alert users to the typically
higher hazards associated with the concentrate product.
If the labeling allows a range of dilution, EPA would permit use
dilution labeling only for the most concentrated dilution. EPA believes
that there is little value in multiple sets of precautionary statements
reflecting various levels of use dilution, and that product users would
find multiple statements cluttering and confusing.
Because the concentrate product typically presents higher hazards
than the diluted product, EPA would not permit dilution-based
statements either to substitute for or modify existing statements for
the concentrate product. Rather, EPA would permit additional statements
that augment the information for the concentrate product to appear
following the concentrate product information. For example, the wording
in italics could be added to precautionary or first aid statements:
HAZARDS TO HUMANS. ``Causes substantial but temporary eye
injury. Do not get in eyes or on clothing. Wear goggles or face
shield. Wash thoroughly with soap and water after handling. Wash
contaminated clothing before reuse. After product is diluted,
goggles or face shield are not required.''
FIRST AID. ``If on skin: Take off contaminated clothing. Rinse
skin immediately with plenty of running water. Call a doctor or
poison control center for further treatment advice. If diluted
product gets on skin, medical attention is not required.''
Separate statements could also be used, with appropriate headings
for ``Concentrate'' and ``Diluted product'' or similar wording.
B. Reorganization of Labeling Regulations
EPA proposes to reorganize Sec. 156.10(h), which describes labeling
requirements pertaining to hazard statements, to upgrade its structure.
EPA believes that this long overdue reorganization is needed to
accommodate the new use dilution provisions, and to improve the
readability of the human hazard and precautionary sections of its
labeling regulations. Ultimately EPA intends to upgrade part 156
entirely, but at present is doing so only as part of other regulatory
proposals that affect labeling.
EPA has already proposed to upgrade the structure of its use
direction labeling requirements as part of its proposal on Pesticides
and Ground Water State Management Plans (June 26, 1996; 61 FR 33260).
That proposal would create subpart G to contain directions for use.
Today's proposal carries this organizational upgrading one step
further. EPA proposes to create new subpart D in part 156 (comprising
Secs. 156.60 through 156.79), and locate in it all human hazard and
precautionary statements, including physical and chemical hazards.
Environmental hazard and precautionary statements, currently located in
Sec. 156.10(h)(2)(ii) would be located in new subpart E.
In reformatting, EPA has reworded the provisions of current
Sec. 156.10(h) for clarity, and is proposing several minor changes:
1. Section 156.64 would eliminate the requirement that a product in
Toxicity
[[Page 50702]]
Category IV by all routes of exposure bear a signal word. Currently,
products in Toxicity Categories III and IV bear the same signal word,
CAUTION. Products in Toxicity Category IV are of minimal toxicity, and
EPA believes that a signal word is not necessary for effecting the
purposes for which the product is intended. Indeed, the same signal
word for two different categories of toxicity may contribute to
misunderstanding of the hazards of products in both categories.
In recent research conducted under the Consumer Labeling
Initiative, users of several types of consumer products tended to
ascribe a higher level of hazard to products bearing the signal word
CAUTION than to products bearing no signal word at all. Thus the signal
word CAUTION on a Category IV product has the potential to be
misunderstood. Users may consider all products bearing the signal word
CAUTION as similar in toxicity, even though those in Toxicity Category
IV pose negligible hazard while those in Category III pose moderate but
real hazards.
The hierarchical Toxicity Category scheme is designed to allow
distinctions to be made among products based on acute toxicity. Signal
words assigned to the four toxicity categories are intended to allow
users to make informed choices about the risks of the products they
purchase. Having the same signal word for two categories runs counter
to this goal. The hierarchy of product toxicity would be easier to
convey on labeling if each category were clearly differentiated from
another. Absent a new signal word to assign to Toxicity Category IV
products, EPA proposes to eliminate the signal word entirely. The label
would still be required to bear the child hazard warning.
2. Section 156.66 would clarify that the child hazard warning,
``Keep Out of Reach of Children'' is not always appropriate for all
products, and that EPA may require or permit an alternative wording of
the statement. This change would codify existing policy.
3. Section 156.68 would require the heading ``First Aid,'' instead
of the currently required ``Practical Treatment,'' for the statement
regarding emergency treatment by a user to mitigate pesticide
exposures. This change was recommended in the Consumer Labeling
Initiative Phase I Report (September 30, 1996), in which consumer
interviews identified label improvements for consumer pesticide and
non-pesticide products.
4. Section 156.68 would also require that a first aid statement
appear on the front panel of the label for each product in Toxicity
Category I, including for the first time eye and skin irritation
effects. Currently, the statement is required on the front panel only
for products in Toxicity Category I based upon systemic effects.
EPA believes that the current distinction between systemic and
irritation effects is not justified. The corrosive effects associated
with exposure to a Toxicity Category I skin or eye irritant are
potentially irreversible, and EPA believes that information on
mitigating those effects should be clearly and immediately available to
the user. Logically, then, first aid measures for skin irritation
should be as prominently located on the label as those for dermal
toxicity. Location on the front panel affords the greatest prominence
to first aid statements.
5. In creating new subpart E in which to locate environmental
hazard and precuationary statements, EPA has included in a general
section (Sec. 156.80) introductory language describing the location and
type size of environmental hazards statements. Otherwise the
requirements are the same as those in current Sec. 156.10(h), and
comment is not requested on this reorganization.
C. Updated Toxicity Categories
EPA had intended to propose to update its current Toxicity
Categories for acute hazard labeling. The Toxicity Categories in
Sec. 156.10(h) were established in 1975 and are no longer current. In
September 1998, however, the United States agreed in principle with the
Organization for Economic Cooperation and Development to harmonize
internationally the classification systems for a number of hazard
criteria, including acute toxicity. The proposed classification scheme
differs markedly from EPA's current scheme, both in the number of and
criteria for acute toxicity categories. Implementation plans for the
new scheme are intended to be developed by the year 2000.
In light of the proposed internationally harmonized scheme, EPA has
decided not to propose to update its toxicity categories. At best,
updating would be an interim step, which would be superseded in 2 to 3
years by U.S. implementation of the new scheme, which itself will be a
major undertaking for the pesticide industry.
XIV. Chemical Sterilants
A. Liquid Chemical Sterilants Excluded by Statute
FIFRA section 2(u) specifically excludes from the definition of
``pesticide'' liquid chemical sterilants (and their subordinate
disinfectant claims) for use on a critical or semi-critical device.
This change in FIFRA was effective on August 3, 1996, and supersedes
the interim guidance outlined in PR Notice 94-4 (June 30, 1994). That
notice pertains to registration procedures for liquid chemical
sterilant products affected by the June 3, 1993 Memorandum of
Understanding (MOU), as amended, between EPA and FDA. In accordance
with the MOU, EPA was preparing a rule to exempt such products from
FIFRA regulation under section 25(b), which would have yielded
regulatory jurisdiction solely to FDA. That proposal is no longer
needed since the jurisdictional change was accomplished statutorily.
The effect of the exclusion under FIFRA is that such products are
regulated solely by FDA as ``devices'' as defined in section 201 of the
FFDCA. EPA has issued a notice to registrants of affected sterilant
products (PR Notice 98-2, January 15, 1998), informing them of the
change in regulatory jurisdiction. Today's proposal will codify in new
Sec. 152.6 the statutory exclusion for liquid chemical sterilants,
though codification is merely a convenience for the regulated community
and is not necessary for the exclusion to be effective.
Codification of the liquid chemical sterilant exclusion does not
change the interim measures outlined in PR Notice 94-4 for general
purpose disinfectants, nor does it affect liquid chemical sterilant
products intended for use on non-medical devices, such as those
intended for use solely on environmental surfaces, or those which are
intended for veterinary purposes.
B. Non-liquid Chemical Sterilants Exempted by Regulation
EPA proposes further to use its authority under FIFRA section 25(b)
to exempt from FIFRA regulation the following additional antimicrobial
product types: (1) Non-liquid chemical sterilants for use on critical/
semi-critical devices, except ethylene oxide; (2) non-liquid chemical
sterilants bearing, in addition, subordinate disinfectant claims for
use on critical/semi-critical devices.
FQPA modified the definition of ``pesticide'' in FIFRA section 2(u)
so as to grant FDA exclusive jurisdiction over
[[Page 50703]]
liquid chemical sterilants for use on critical/semi-critical devices.
Congress did not, however, address non-liquid chemical sterilants,
which have similar uses as liquid chemical sterilants. In fact, under
FFDCA section 510, FDA regulates all chemical sterilants used on all
medical devices, not just liquid chemical sterilants on critical and
semi-critical devices. In modifying FIFRA, Congress affirmed that FDA
jurisdiction under FFDCA section 510 was an adequate means of
regulating these sterilant products, and that dual oversight with EPA
was unnecessary to protect the public health.
FIFRA section 25(b) authorizes EPA, by regulation, to exempt a
pesticide from any or all provisions of FIFRA if the pesticide is
adequately regulated by another Federal agency. EPA believes that
Congress' expression of the adequacy of FDA's approval process for
liquid chemical sterilants and their subordinate disinfection claims on
critical/semi-critical devices as a statutory matter is an adequate
basis for EPA to determine that non-liquid chemical sterilant products
regulated under the same approval process are adequately regulated by
another Federal agency.
C. Antimicrobial Products Neither Excluded nor Exempted
1. Any claims on non-critical medical devices. EPA does not propose
to exempt sterilants or disinfectant products used on non-critical
medical devices from FIFRA regulation. Non-critical medical devices
potentially cover a wide array of items and surfaces, such as blood
pressure cuffs and bedpans. EPA and FDA currently share jurisdiction
over products used on non-critical medical devices. However, under its
1993 MOU with FDA, EPA and FDA agreed to an approach under which FDA
would grant sole responsibility for products used on non-critical
medical devices to EPA. FDA has issued a proposal to exempt general
purpose disinfectant products from the requirement for pre-market
clearance under FFDCA section 510(k) (63 FR 59917, November 6, 1998).
2. Any claims on non-medical devices. EPA has sole jurisdiction
over all claims on non-medical devices. These products are not
regulated jointly with FDA.
The combination of the statutory exemption for liquid chemical
sterilants and the exemptions proposed under FIFRA section 25(b) would
give FDA sole jurisdiction over all chemical sterilants (except
ethylene oxide), together with their subordinate level disinfection
claims for use on all critical and semi-critical medical devices.
Exempting from FIFRA coverage additional sterilants and uses and
consolidation of regulatory jurisdiction with FDA will eliminate dual
regulatory requirements and unnecessary paperwork requirements.
Table 5 below sets out concisely the status of chemical sterilants
and other antimicrobial products used on medical devices, and the
statutory and regulatory transfers that are occurring for liquid and
non-liquid chemical products. Where the table indicates ``no change''
in the last column, the jurisdiction has not changed by statute, and
EPA is not proposing any regulatory change.
Table 5.--Antimicrobial Products Used on Medical Devices
----------------------------------------------------------------------------------------------------------------
Is under the
Product In this form-- For this Use-- Jurisdiction of-- By Virtue of--
----------------------------------------------------------------------------------------------------------------
Sterilant + any subordinate Liquid Critical/semi- FDA Statutory
level disinfectant claim critical medical exclusion
(except ethylene oxide) devices
-----------------------------------------------------------
Non-critical FDA and EPA No change
medical devices
-----------------------------------------------------------
Sites other than EPA No change
medical devices
-------------------------------------------------------------------------------
Non-liquid Critical/semi- FDA FIFRA exemption
critical medical
devices
-----------------------------------------------------------
Non-critical FDA and EPA No change
medical devices
-----------------------------------------------------------
Sites other than EPA No change
medical devices
----------------------------------------------------------------------------------------------------------------
Products bearing disinfectant or All forms Non-critical EPA and FDA No change
sanitizer claims only medical devices
-----------------------------------------------------------
Sites other than EPA No change
medical devices
----------------------------------------------------------------------------------------------------------------
D. Ethylene Oxide
Ethylene oxide is a gaseous form of sterilant, and thus was not
transferred to FDA jurisdiction by statute. EPA does not propose to
exempt the sterilant ethylene oxide because, in contrast to the other
non-liquid sterilants that would be exempted, ethylene oxide use is not
limited to medical and hospital use. Ethylene oxide is used as a
fumigant for foods, particularly for fumigation of whole spices, a use
regulated by no other Agency except EPA. Thus, even if EPA were to
exempt the ethylene oxide sterilization use on critical/semi-critical
devices, EPA might retain significant oversight over ethylene oxide for
other uses. It makes sense, then, for EPA to retain jurisdiction over
the sterilant use of ethylene oxide on medical devices.
XV. Nitrogen Stabilizers
A. Nitrogen Stabilizers are Regulated as Pesticides
FQPA expanded the FIFRA definition of ``pesticide'' to include
nitrogen stabilizers, but by definition in FIFRA section 2(hh)
``nitrogen stabilizer'' excludes certain substances. Two named
substances (dicyandiamide and ammonium thiosulfate) are excluded
outright. Other substances are excluded
[[Page 50704]]
if they meet the criteria in section 2(hh)(3): They were introduced
into commercial agronomic use by January 1, 1992, without being
registered under FIFRA, and thereafter have not made specific claims of
``prevention or hindering of nitrification, denitrification, ammonia
volatilization [or] urease production'' (collectively referred to in
this discussion as ``nitrogen stabilization claims''), except where
required to do so under State pesticide regulations.
EPA proposes to add to new Sec. 152.6 those substances that are not
nitrogen stabilizers by statutory definition and therefore not
regulated as pesticides when used for nitrogen stabilization purposes.
All other nitrogen stabilizer products are regulated as pesticides
under FIFRA. This unit discusses how EPA will determine which nitrogen
stabilizers it will treat as pesticides.
B. What is a Nitrogen Stabilizer?
1. Action on soil bacteria. To be a nitrogen stabilizer in the
first instance, a product must accomplish the purpose of nitrogen
stabilization through ``action upon soil bacteria.'' Clearly, this
phrase excludes fertilizer products, which increase soil nitrogen by
simple addition of nitrogen-containing substances rather than any soil
bacterial action. However, any product that enhances soil nitrogen
availability by affecting the soil bacteria is a nitrogen stabilizer,
regardless of whether it also functions as a fertilizer after action on
soil bacteria. Such dual products that function both as nitrogen
stabilizers and fertilizers are regulated under FIFRA if they meet the
other statutory criteria for nitrogen stabilizers.
2. Date of introduction into commerce. The first criterion pertains
to the date of introduction of the product into commerce. Section 2(hh)
specifies January 1, 1992, as the date before which the product must
have been in ``commercial agronomic use'' but not registered as a
pesticide (as well as the date after which no specific claims of
nitrogen stabilization must have been made in connection with its sale
and distribution; see below). EPA can verify from its records what
products were registered before January 1, 1992 (these are nitrogen
stabilizers that must continue to be registered). EPA interprets
``commercial agronomic use'' to mean that a product is being
distributed and sold at the wholesale and retail levels. A product that
is being distributed only in a limited or restricted way in preparation
for full marketing is not considered to have achieved commercial
marketing status.
3. Specific claims. The second criterion relates to claims made for
the product. The statute does not define what is meant by a ``specific
claim of prevention or hindering of the process of nitrification,
denitrification, ammonia volatilization [or] urease production.''
Moreover, there is no explanatory legislative history to guide EPA in
discerning Congressional intent. Therefore, EPA is interpreting the
phrase in a common sense manner.
Nitrification, denitrification, ammonia volatilization, and urease
production denote specific undesirable actions of soil bacteria with
the result that nitrogen availability is decreased. Clearly, any
product that uses these terms on the label is making a ``specific
claim'' of mitigating that effect. However, other claims which focus
only on the end result of nitrogen stabilization (increased/prolonged
availability of nitrogen) are also used on product labels. EPA
identifies examples of these phrases in proposed Sec. 152.6(b)(4). The
phrases listed in that section, to the Agency's knowledge, could be
used to describe only two functions of products--either the fertilizer
effect of addition of slow-release nitrogen-containing substances, or
the pesticidal effect on soil bacteria that is nitrogen stabilization
and has the same end result.
Although these label claims could theoretically be used to describe
fertilizers, EPA believes that they are in practice claims of nitrogen
stabilization rather than fertilizer claims, for the following reasons.
First, fertilizer products are already excluded from FIFRA regulation
by EPA's own regulations in Sec. 152.8, and a fertilizer product need
only be labeled as such (and bear no other pesticide claims) to avoid
FIFRA regulation. It would make little sense for a fertilizer product
to bear claims such as ``increases nitrogen uptake'' or ``prolongs
nitrogen availability'' when a simple declaration as a ``fertilizer''
would suffice under FIFRA, and ``fertilizer'' is a description of such
a product that would be understood by all purchasers. The only other
plausible use of these ambiguous claims relates to nitrogen stabilizing
effects on soil bacteria.
More telling is EPA's experience in evaluating such products. A
first-hand examination of the labeling and ingredients declaration of a
product is the most reliable method to determine if products with such
claims are to be regulated under FIFRA. An examination of this sort is
similar to the process used for many years to determine the pesticide/
non-pesticide status of plant regulators (pesticide) versus fertilizer
(non-pesticide) products. In each instance that EPA has examined a
product bearing a claim such as described in Sec. 152.6(b)(4), EPA has
determined that the product was, in fact, functioning as a nitrogen
stabilizer, and that the product composition was consistent with an
expected nitrogen stabilization purpose rather than, or in addition to,
a fertilizer purpose.
Moreover, such an interpretation of indirect claims is in keeping
with EPA's past and current policies on nitrogen stabilizers. EPA's
policy has been to treat claims that indicate pesticidal intent as
pesticide claims that subject the products to regulation under FIFRA.
Therefore, EPA proposes to treat any claim that states or implies that
the product will prevent or hinder nitrification, denitrification,
ammonia volatilization, or urease production as a claim that brings the
product under the purview of FIFRA as a nitrogen stabilizer. If a
product functions solely as a fertilizer or a slow- or delayed-release
fertilizer, is labeled as such with explanatory information on the
method used to accomplish any delayed- or slow-release action (e.g., by
encapsulation) and bears no additional claims that appear to be
nitrogen stabilization claims, it would not be considered a pesticide.
EPA believes that to do otherwise would create an administrative
and enforcement inequity that could potentially undermine the intent of
the statute to the point where it would have little practical effect.
The purpose of incorporating nitrogen stabilizers into the definition
of ``pesticide'' in FIFRA section 2(u) is to regulate certain nitrogen
stabilizers as pesticides. If EPA were to interpret the Act to limit
the regulatory coverage of nitrogen stabilizers to products that use
the magic words ``nitrification,'' ``denitrification,'' ``ammonia
volatilization,'' or ``urease production,'' while ignoring other
language that makes equivalent but differently phrased claims, a
product that Congress intended to be regulated could escape FIFRA
regulation merely by using a ``code phrase'' that conveys the same
meaning as these terms. Arguably, under such a restrictive
interpretation, the only nitrogen stabilizers covered by FIFRA might be
those already registered as of January 1, 1992. EPA believes that
Congress could not have intended to extend coverage of FIFRA to
nitrogen stabilizers, only to exclude most or all of those products by
a mere turn of phrase.
4. State exclusion. Congress did provide a specific exclusion for
statements that are required by State
[[Page 50705]]
legislative or regulatory authorities. A product that makes a claim of
nitrogen stabilization in its labeling or other materials only because
of a State requirement is not thereby brought under FIFRA regulation.
Congressional intent is clear: Federal regulatory authority over
nitrogen stabilizers should not be enlarged by actions of the States.
Nor does EPA believe that Congress intended that a product that
triggered Federal regulation by making nitrogen stabilizer claims be
removed from regulation by subsequent action of a State. Proposed
Sec. 152.6 therefore makes clear that the State requirement for
labeling must be a pre-existing one, that is, in place prior to the
assertion of nitrogen stabilizing claims by the seller or distributor.
Moreover, a product for which nitrogen stabilization claims are
made because of a State requirement is nonetheless subject to FIFRA
regulation if at any time since January 1, 1992, nitrogen stabilization
claims have been made for the product with respect to its distribution
and sale in another State that does not have such a requirement. Sale
or distribution of such a product in any State, including the State
which imposed the labeling requirement, is subject to the provisions of
FIFRA.
The producer of a product who claims eligibility under this
exclusion would need to maintain sufficient records to clearly
demonstrate that, as of January 1, 1992, the product was being
commercially distributed and sold (sales records, for example), and
that no nitrogen stabilization claims were made after that date (dated
copies of labeling and advertising, for example). These records are
maintained by producers as a normal business practice, so no additional
recordkeeping would be required by this proposal.
XVI. Notification of Registration Changes
A. FQPA Modifications
EPA proposes to modify its current notification procedures for
antimicrobial products to conform to those established under FIFRA
section 3(c)(9). The statutory provisions requiring these changes are
discussed in Units IV.I. and V.B.
Prior to FQPA, FIFRA did not provide a notification scheme. In
1988, EPA implemented a regulatory notification framework (contained in
Sec. 152.46), under which EPA determines acceptable modifications to
registration that may be made by notification. The types of acceptable
notifications are set out in direct notices to registrants, together
with the procedures for submitting notifications.
FQPA modified FIFRA with respect to notifications for antimicrobial
pesticides only, in both substance and procedure. For the first time,
FIFRA establishes a statutory right for antimicrobial registrants to
make certain types of changes by notification. Specifically, a
registrant may modify the labeling of an antimicrobial pesticide
product to include relevant information on product efficacy, product
composition, container composition or design or other characteristics,
that do not relate to any pesticide claim or pesticidal activity.
Further, FIFRA sets up a procedure for antimicrobial notifications that
holds both registrants and EPA to a high degree of accountability.
FIFRA section 3(c)(9) became effective on August 3, 1996; today's
proposal would codify the procedures of the Act that are already in
effect. Neither current regulations nor this proposal address the types
of actions that may be accomplished by notification.
The notification provisions of the Act apply only to antimicrobial
products. As a policy matter, EPA could extend both the types of
notifications and the procedures for notifications to other products.
After consideration, EPA has decided to allow non-antimicrobial
registrants to avail themselves of the new types of notifications
provided by FIFRA section 3(c)(9), but will not propose changes in its
current procedures for notifications for such products. Although EPA
believes that the new statutory process for antimicrobials is superior
in some ways to the existing notification scheme, it is reluctant to
add an additional procedural layer to a system that appears to work
well as currently administered.
Consequently, after the effective date of the rule, EPA would have
in place two notification schemes (antimicrobials/other pesticide
products), but would have a unified set of notification actions. After
the effective date of the rule, antimicrobial registrants would be
required to follow the notification procedures of Sec. 152.446 only;
they would not be permitted to follow the current procedures in
Sec. 152.46. EPA welcomes comment on whether the notification
procedures for antimicrobials should be adopted across-the-board. If
persuaded by commenters that there are benefits without undue costs in
making the procedures for notifications uniform for all products, EPA
could, in the final rule, adopt the procedures across-the-board. If it
does so, EPA would simply adopt the provisions of Sec. 152.446 to
replace those currently in Sec. 152.46.
Although EPA does not propose to apply the new procedures to all
products, it believes that the types of notifications permitted by
FIFRA section 3(c)(9) should be extended to all products rather than
limiting them to antimicrobials. Doing so does not require that EPA
modify its regulations in Sec. 152.46, since permitted notifications
are detailed in direct notices to registrants (PR Notices), a practice
EPA would continue. Current permitted notifications are specified in PR
Notice 98-10, issued October 22, 1998.
B. Comparison of Current and New Procedures for Antimicrobial Products
This unit describes the new procedures for antimicrobial product
notifications and compares them to the current procedures for all other
products, which are not proposed for change. The significant
differences between antimicrobial procedures and current notification
procedures in Sec. 152.46 are that:
1. Registrants who submit antimicrobial notifications must wait 60
days after submission before distributing or selling the modified
product. Registrants of other products may distribute or sell
immediately upon submission.
The new scheme offers an eminently practical solution for the
uncertainties of compliance and enforcement in the current notification
process. Under the current scheme, a registrant who ships immediately
upon notification runs the risk that EPA might thereafter determine the
notification is improper, and the product would be in violation of
FIFRA. Because FIFRA section 3(c)(9) prohibits sale and distribution of
a modified product for 60 days after submission, but requires Agency
action within 30 days, there will always be some period of time after
the Agency's decision before an antimicrobial product can be shipped
legally. There is no possibility (as exists under the current scheme)
that a registrant will ship an antimicrobial product only to have the
Agency disapprove the notification. The benefit of certainty is
somewhat offset by the fact that an antimicrobial registrant must wait
before shipping. However, EPA proposes in Sec. 152.446 to allow
shipment at any time after receipt of approval by the Agency (30 days),
thereby almost halving the 60-day waiting time.
2. EPA is obligated to disapprove antimicrobial notifications it
finds unacceptable within 30 days after receipt. Under the current
process,
[[Page 50706]]
EPA's goal is to make its determination within 30 days, but it is not
required to do so.
The new process involves some increase in resources and time on
EPA's part. Requiring a review and specific disapproval decision within
30 days of receipt is more demanding than the current scheme which
lacks a decision deadline. Nonetheless, antimicrobial notifications are
currently being processed within 30 days, so EPA anticipates little
pressure on its current antimicrobial program resources to accommodate
the 30-day decision deadline.
3. EPA may require substantiating information for an antimicrobial
notification. Current EPA regulations in Sec. 152.46 do not explicitly
mention substantiation. EPA proposes that antimicrobial registrants be
required to retain, and submit upon request, substantiating information
for each modification. Substantiating information might be required to
be submitted if the registrant objected to the Agency's disapproval of
his/her notification. The provision for substantiation of claims for
antimicrobial products offers EPA greater assurance that the claims are
in fact accurate, and can be verified objectively or scientifically.
4. Antimicrobial registrants may formally object to the Agency's
disapproval of an antimicrobial notification. Current Sec. 152.46
contains no provision for appeal of an Agency disapproval. The
availability of an administrative appeals process, if used frequently,
would increase resource needs to administer the process. However, EPA
anticipates few appeals since the types of notifications permitted by
the statute are relatively straightforward decisions for which the
current notification scheme was designed.
XVII. Conforming and Organizational Changes
A. Changes in Definitions
EPA is proposing to modify, delete, or add a number of definitions
to Sec. 152.3. Definitions located in Sec. 152.3 apply to all pesticide
applications, including antimicrobial applications. The definition of
``pesticide'' would be deleted because it has become so long and
complicated in the statute itself that it adds no value to reiterate
the definition in regulations. The definition of ``active ingredient''
would be modified to conform to the change made by FQPA adding nitrogen
stabilizers. Definitions to be added include the following:
1. ``Antimicrobial pesticide,'' to allow reference to new subpart
W. The definition proposed here interprets the statutory definition to
clarify and give practical meaning to the exclusions from the
definition for ``wood preservative,'' ``antifouling paint product,''
``fungicide for agricultural use'' and ``aquatic herbicide.''
2. ``Applicant,'' ``registrant'' and ``application for
registration,'' to create concise terms that cover both new and amended
registrations.
3. ``Complete application.'' This definition is being added to
apply to all pesticide applications because a number of FIFRA
provisions (not just those for antimicrobial products) depend upon the
submission of a ``complete application,'' including: (1) the timeframes
for all ``fast-track'' applications under section 3(c)(3)(B); (2) the
priority given to review of minor use applications under section
3(c)(3)(C); and (3) the priority given to so-called ``safer''
pesticides under section 3(c)(10). For antimicrobial pesticides,
Sec. 152.450 contains detailed information on what constitutes a
complete application.
4. ``Fast-track application,'' to formalize the term widely used by
the Agency and the regulated community for applications under FIFRA
section 3(c)(3).
5. ``Nitrogen stabilizer,'' to include the statutory term here for
convenience.
B. Exclusions and Exemptions under FIFRA
EPA proposes to compile in one location in its regulations the
various exclusions that have accumulated in FIFRA over the years.
Exclusions from FIFRA regulation are statutorily designated substances
that are not to be regulated under FIFRA. Readers should note that
``exclusions'' do not include exemptions granted under FIFRA section
25(b), which are pesticides specifically removed from FIFRA regulation
by Agency action.
Several exclusions already exist in FIFRA, and are identified in
current regulations. These include:
1. Substances used against organisms that are not ``pests'' by
definition in FIFRA section 2(t).
2. Substances that are not ``pesticides'' by definition in FIFRA
section 2(u).
3. Substances that indirectly are not ``pesticides'' by virtue of
being excluded from definitions of substances that are pesticides, such
as ``vitamin-hormone horticultural products,'' which are excluded from
the definition of ``plant growth regulator'' in FIFRA section 2(v).
FQPA amended FIFRA to add two additional exclusions for substances
that are not to be regulated under FIFRA. Because the existing
exclusions are scattered in FIFRA and have been expanded by FQPA, EPA
believes it would be useful and convenient to consolidate them in one
location in its regulations. Accordingly, EPA proposes to create new
Sec. 152.6 and to include in it both existing and new exclusions.
Existing exclusions, which have not been altered, include those in
Sec. 152.8 for pests of living man and animals (human and animal drugs)
and various soil amendment products, in Sec. 152.20 for human drugs and
in Sec. 152.25 for vitamin hormone products. New exclusions include
those for certain liquid chemical sterilants and certain nitrogen
stabilizer products. EPA believes that proposed Sec. 152.6 contains all
exclusions provided by statute or existing regulations. If EPA finds
that it has inadvertently omitted any exclusions provided by statute,
it will in the final rule add them to Sec. 152.6.
XVIII. Consultations During the Development of this Proposal
FIFRA section 3(h) requires that EPA, in developing this proposed
regulation, ``solicit the views from registrants and other affected
parties to maximize the effectiveness of the rule development
process.'' EPA has consulted, and maintains an open dialogue with, a
number of interested parties, both in establishing the streamlined
antimicrobial program itself and in developing this proposal.
A. Stakeholder Meetings
Stakeholder meetings were begun shortly after enactment of FQPA--
the first was in November 1996--with a view to engaging the
antimicrobial industry (which is largely composed of small businesses),
public health, consumer and environmental groups, in discussions and
suggestions that could be implemented in the rule. Since then, EPA has
held a number of open public meetings, approximately every quarter, to
discuss issues arising from the development of the antimicrobial rule
and the administration of the antimicrobial registration program. These
open meetings have been announced in the Federal Register and have been
attended by registrants, trade associations representing antimicrobial
producers and users, other Federal agencies, and environmental and
consumer groups. Information about the meetings and summaries have been
placed in a public docket (OPP docket control number 00473, located at
the address given under ADDRESSES). EPA
[[Page 50707]]
intends to conduct further meetings of this nature, and will make
special efforts to continue and expand the participation of small
businesses in the dialogue fostered through such meetings.
To enhance pre-proposal input into the regulatory development
process, draft language for this proposal was released to the public in
April 1997, and again in June 1998. Ensuing discussions and comments
raised a number of issues of concern. Among them were the following:
1. The opportunity to rebut Agency's conditions of registration.
When EPA issues a registration, it often does so with conditions
attached, generally labeling changes. Registrants have not had the
opportunity to have EPA reconsider conditions they believed were
onerous or unnecessary. EPA has now modified the proposal to allow
applicants who disagree with EPA's imposition of labeling changes as a
condition of registration to submit a rebuttal for consideration.
2. A shorter review period for resubmissions. Industry was
concerned that EPA might choose to start its review clock over for
minor resubmissions to complete an application or respond to Agency
questions. In response, EPA is proposing a specific new category of
shortened review period for ``qualifying resubmissions.'' This new
category would shorten the review period that would otherwise apply by
30 days for applications with review periods of 120 days or less. EPA
estimates that approximately 75% of antimicrobial applications each
year would have review periods of 120 days or less, and would benefit
from this provision.
3. How EPA would deal with indications of product lack of efficacy.
EPA had considered a scheme whereby applicants would agree to accept as
a condition of registration the imposition of a variety of measures if
their product was found to be inefficacious after registration.
Industry was concerned about the vague nature of EPA's proposal, and
viewed it as potentially costly. As a result, EPA has scrapped this
scheme, and developed a new one (the sunset provision in Sec. 152.458),
to respond to their concerns.
B. Workshops
To complement the stakeholder meetings and extend their approach to
stakeholder involvement to a larger group of participants, on January
8-9, 1997, EPA held a highly successful 2-day antimicrobial regulation
workshop attended by over 300 participants. At a number of plenary
sessions and small discussion groups, EPA explored with participants
issues such as improving and streamlining the registration process for
antimicrobial products, self-certification, harmonization with States
and the international community, applying for registration, and
antimicrobial data requirements. A second workshop was held on June 15-
16, 1998, and was attended by an even larger group of stakeholders. A
major trade association with extensive small business membership was
fully represented at both workshops. In addition, individual
representatives of more than 15 small firms attended.
C. Food and Drug Administration
FQPA modified both FIFRA and FFDCA in ways that either explicitly
or effectively transferred regulatory authority over a number of
pesticides between EPA and FDA. As a result, EPA has consulted
frequently with FDA in preparing this proposal with respect to liquid
chemical sterilants (see Unit. XIV.) and the transfer of regulatory
jurisdiction over certain food use antimicrobial residues back to FDA
(see Unit XI.).
D. Canada
In the fall of 1996, EPA held discussions with the Pest Management
Regulatory Agency of Health Canada, which is the Canadian government
agency responsible for regulation of certain antimicrobial pesticides
in Canada. These consultations focussed primarily on Canada's system of
categorizing antimicrobial pesticide types, its administrative
procedures that EPA might adopt to streamline, simplify and accelerate
the Agency's procedures, and ways to harmonize data requirements for
antimicrobial products.
Although the majority of the discussions targeted administrative
rather than regulatory changes, EPA has included in this proposal
expanded application contents (Sec. 152.450) that will, in addition to
assisting U.S. regulators of antimicrobial pesticides, foster
harmonization of application reviews between Canada and the U.S. For
example, the requirement that an applicant supply copies of available
data reviews conducted by other countries (such as Canada) will
contribute to more efficient regulation of antimicrobial products. In
addition, EPA's rigorous application of completeness criteria as a
resource management tool mirrors that of Canada.
XIX. Table of Affected Sections
Because today's proposal covers myriad and diverse topics that
affect several portions of the Code of Federal Regulations, EPA has
summarized in Table 6 below all parts and sections for which additions
or changes are being proposed today.
Table 6.--CFR Sections Affected by Proposal
------------------------------------------------------------------------
CFR Part or Section Number Title Proposed Action
------------------------------------------------------------------------
Sec. 152.1 Scope Conforming changes
------------------------------------------------------------------------
Sec. 152.3 Definitions Additions
------------------------------------------------------------------------
Sec. 152.6 Substances New
excluded from
regulation by
FIFRA
------------------------------------------------------------------------
Sec. 152.8 Products that are Material moved to
not pesticides Sec. 152.6
because they are
not for use
against pests
------------------------------------------------------------------------
Sec. 152.20 Exemptions for Material moved to
pesticides Sec. 152.6; new
regulated by material added
another Federal
agency
------------------------------------------------------------------------
Sec. 152.25 Exemptions for Material moved to
pesticides of a Sec. 152.6
character not
requiring FIFRA
regulation
------------------------------------------------------------------------
Sec. 152.44 Application for Clarification and
amended reformatting
registration
------------------------------------------------------------------------
[[Page 50708]]
Part 152, subpart W (Secs. Registration of New
152.440 - 152.459) Antimicrobial
Products
------------------------------------------------------------------------
Sec. 156.10 Labeling Material moved to
requirements new subparts D
and E; conforming
changes
------------------------------------------------------------------------
Part 156, subpart D (Secs. Human Hazard and Reorganized
156.60 - 156.78) Precautionary material from
Statements Sec. 156.10
------------------------------------------------------------------------
Part 156, subpart E (Secs. Environmental Reorganized
156.80 - 156.85) Hazard and material from
Precautionary Sec. 156.10
Statements
------------------------------------------------------------------------
Part 156, subpart W (Secs. Public Health New
156.440 - 156.458) Claims for
Antimicrobial
Products
------------------------------------------------------------------------
XX. Statutory Review Requirements
In accordance with FIFRA section 25(a), this proposal was submitted
to the FIFRA Scientific Advisory Panel, the Secretary of Agriculture
(USDA), the Secretary of Health and Human Services (HHS), and
appropriate Congressional Committees. The Scientific Advisory Panel
waived its review of this proposal.
A. USDA Comments
1. USDA suggested that the document include a discussion of the
issues surrounding microbial pest resistance.
Response: While there is evidence that microorganisms develop
resistance to antibiotics, EPA is not aware of evidence that
microorganisms are developing resistance to antimicrobial pesticides.
Microorganisms respond to biocidal agents, and differ markedly in
susceptibility and resistance responses to agents such as disinfectants
and antiseptics. Bacterial resistance to biocides is usually considered
to be of two types: (1) Intrinsic (a natural property of an organism);
or (2) acquired (by genetic mutation or physiological adaptation). The
mechanisms of susceptibility and resistance to biocides and techniques
that would enhance or reduce susceptibility/resistance are not well
understood and would require further research.
EPA expects that it would become aware of developing microbial pest
resistance in public health products either through registrant
reporting of lack of efficacy under FIFRA section 6(a)(2) or through
the 5-year retesting program. A public health product that failed to
demonstrate efficacy at the 5-year mark would be removed from the
marketplace by automatic expiration of the registration.
2. USDA suggested that EPA clarify in the proposal the status of
agricultural microorganisms other than fungi, for example, nematodes.
Response: EPA has revised Unit VI.C. of the preamble and the definition
of ``antimicrobial pesticide'' in Sec. 152.3 to clarify that an
agricultural fungicide is one applied to crops or plants pre-harvest.
It should be noted that nematodes are not considered microorganisms,
but invertebrates, and thus would not be included in the definition of
antimicrobial pesticide in any case.
3. USDA suggested that EPA standardize the review processes and
times for wood preservatives and antifoulant paints.
Response: FIFRA section 2(mm) specifically excludes wood preservatives
and antifoulant paints from the definition of ``antimicrobial
pesticide,'' and thus, with only limited exceptions, also excludes such
products from the application review periods that this proposal would
establish for antimicrobial pesticides. Therefore, EPA is not proposing
to include wood preservatives and antifoulant paints within the scope
of this regulation and its review periods. Unit VIII.H.4. contains a
full explanation of when the review periods apply to certain wood
preservative products. The review periods discussed in that unit,
however, do not extend to antifoulant paints.
As a practical matter, the review processes for all wood
preservatives and antifoulant paints are the same regardless of where
within the EPA organization they originate. The data requirements and
risk assessments for such products are the same and depend on the
chemical and the potential risks from its use, regardless of whether
there is a statutory review period.
B. HHS Comments
HHS provided informal comments on the draft, many of which were
questions, clarifications, or corrections to the proposal. EPA has made
changes to the draft proposal in many instances based upon their
suggestions. A brief summary of their substantive comments follows.
1. HHS wanted to know the relationship between ``antimicrobial
pesticides'' and ``public health pesticides'' and whether they were
treated differently in the proposal.
Response: Both terms are defined in FIFRA. ``Antimicrobial pesticide''
is defined in FIFRA section 2(mm) to include, among other things,
products intended to ``disinfect, sanitize, reduce, or mitigate growth
or development of microbiological organisms.'' ``Public health
pesticide'' is defined in FIFRA section 2(nn) to include products for
the ``. . . prevention or mitigation of viruses, bacteria, or other
microorganisms . . . that pose a threat to public health.'' An
antimicrobial pesticide may be a public health pesticide if it is
intended to destroy or mitigate microoganisms that pose a threat to
public health.
However, there is a single standard for registrability of a
pesticide in FIFRA section 3(c)(5), namely that the pesticide itself,
or in its intended use, not cause ``unreasonable adverse effects'' on
man or the environment, taking into account the economic, social, and
environmental costs and benefits of the use of the pesticide. This is a
risk/benefit balancing provision. Of significance, though, is that EPA
is specifically directed to take into account the health risks posed by
the disease vectors controlled by a public health pesticide when
weighing its risks and benefits. Under FIFRA section 6(b)(2), when EPA
is contemplating action against a public health pesticide based on
risk, HHS should provide information on use and benefits to the Agency
to inform its risk/benefit decision.
2. HHS asked about the scope of the proposed rule in relation to
HHS activities under FFDCA section 409. HHS noted the statutory
definition of ``antimicrobial pesticide'' in FIFRA,
[[Page 50709]]
which excludes pesticides that require a clearance under either FFDCA
secton 408 or 409. HHS also noted that ARTCA grants jurisdiction over
many antimicrobial pesticide residues in food to FDA (discussed in Unit
XI.), but it still requires registration of the pesticides under FIFRA.
Response: The definition of ``antimicrobial pesticide'' applies only to
registration activities under FIFRA; it does not affect activities
related to any FFDCA section 409 food additive regulation. EPA has no
jurisdiction under section 409. Any action affecting the registration
of an antimicrobial pesticide under FIFRA, such as cancellation or
expiration under the ``sunset provision,'' would not necessarily
require that FDA revise or revoke any food additive regulations
associated with that pesticide.
A similar situation could arise if EPA has established a tolerance
or exemption under section 408 for a pesticide whose registration has
expired under the sunset provision. As noted in Unit IX, the sunset
provision is intended to ensure efficacy of public health products, not
to determine whether the tolerance fails to meet the ``reasonable
certainty of no harm'' standard of FFDCA. It is unlikely that the
cancellation or expiration of any single product registration would
trigger action to revoke the tolerance because there likely would
remain other products on the market for the same use that are supported
by the same tolerance or food additive regulation.
That said, EPA proposes to include all antimicrobial products in
the scope of its proposed regulation. Unit VIII.B contains a full
explanation of the applicability of subpart W. Under Sec. 152.441,
subpart W applies not only to ``antimicrobial pesticides,'' but also to
antimicrobial products whose registration requires a clearance under
FFDCA section 408 or 409. Because the proposed rule affects only FIFRA
actions, however, the difference in coverage of the statutory term
``antimicrobial pesticide'' and the broader coverage of the proposed
rule is not expected to affect HHS activities under FFDCA over those
same pesticides.
3. HHS commented that EPA's proposal would expand the scope of FDA
authority over chemical sterilants beyond that agreed to by EPA and
FDA.
Response: EPA has revised the proposal to align its provisions with
FDA's understanding of our respective responsibilities (see Unit XIV.).
4. HHS comments suggested several areas where increased EPA/FDA
consultation was desirable or necessary, for example, enforcement of
labeling claims for products subject to both EPA and FDA jurisdiction.
Response: EPA and HHS are in the process of developing a Memorandum of
Understanding (MOU) that would address responsibilities and
consultations in a number of areas. The MOU is expected to establish a
consultative process between the Agencies that will facilitate
information exchange and resolution of issues. EPA expects that the
consultations undertaken under the MOU will serve the various purposes
noted by FDA. Currently EPA consults informally with counterparts in
the FDA, the Centers for Disease Control, and other HHS offices on
issues of joint authority and mutual interest.
5. HHS requested that EPA clarify the status under the Freedom of
Information Act (FOIA) of data and/or data reviews provided to other
agencies if the applicant authorizes EPA to share such data.
Response: The status of data provided to another agency under a
registrant authorization would not change under FOIA because of the
data sharing. A request to HHS for the release of such data would be
treated the same under FOIA as a request to EPA.
6. HHS had a number of comments related to the efficacy performance
standards (part 156, subpart W).
a. Virucidal claims. HHS suggested that EPA consider selecting
representative viruses with differing intrinsic resistance to
antimicrobial chemicals and use those as benchmark viruses for test
purposes in support of a general virucidal claim.
Response: Currently, EPA requires that each specific virus intended to
be claimed on the label be tested, and identified on the labeling. EPA
takes the position that there is no known data base that assures that
all viruses have the same susceptibility or resistance responses to
antimicrobial agents, or that allows across-the-board extrapolation of
results. Nonetheless, EPA has funded a 3-year research project on the
use of surrogate viruses. The results from this study are currently
under review.
b. Efficacy terminology. HHS noted that there are differences in
terminology between EPA and HHS performance measures. HHS considers a
laboratory test demonstrating product efficacy to be a test of a
chemical's ``potency'' and not its ``efficacy.'' HHS believes that
``efficacy'' is demonstrated only in the ability of an antimicrobial
agent to reduce or prevent transmission of disease.
Response: EPA acknowledges these differences. In the case of
antimicrobial pesticides, EPA uses the term ``efficacy'' to refer to
laboratory testing that demonstrates ``presumptive'' efficacy of a
product in reducing microbial populations on environmental surfaces.
FIFRA specifically excludes as pests microorganisms in or on living man
or other living animals (as opposed to microorganisms on surfaces to
which man might be exposed). Effectiveness testing that would
demonstrate performance of an antimicrobial pesticide against
microorganisms in man and that would meet HHS' definition concerning
actual reduction or prevention of disease is not within EPA's purview.
Based upon the laboratory tests that demonstrate efficacy for FIFRA
purposes, EPA permits label claims only to the extent that the product
reduces or eliminates target organisms under standard laboratory
conditions or carefully defined simulated use protocols. Because EPA
does not require or evaluate data on disease-related claims,
antimicrobial pesticide products are not permitted to bear claims
concerning reduction in transmission or prevention of disease, though
they may claim the ability to reduce precursor microorganisms.
c. ``Sanitization'' claims. HHS requested clarification of the
scope of the Agency's policy on ``sanitary'' and ``sanitize'' as
pesticide public health claims. HHS noted that a product that
``sanitizes'' food equipment would not be an ``antimicrobial
pesticide'' under FIFRA section 2(mm) because such use would be a food
use requiring a tolerance or exemption under section 408. They
requested clarificaiton as to whether such a sanitizer would be subject
to subpart W labeling requirements, and whether it would be a public
health pesticide.
Response: Yes. A pesticide that sanitizes food equipment would be a
public health pesticide because sanitization is a claim of a specific
level of antimicrobial activity against microorganisms associated with
public health protection. It would therefore be subject to the labeling
requirements of proposed subpart W of part 156. As noted earlier, the
definition of ``antimicrobial pesticide'' in the proposal is broader
than that in the statute. EPA has revised Sec. 156.440 to clearly state
that the applicability of part 156, subpart W, corresponds to that in
part 152, subpart W, which would encompass food use sanitizers.
[[Page 50710]]
XXI. Regulatory Assessment Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993),
entitled Regulatory Planning and Review, this action is not a
``significant regulatory action'' subject to review by the Office of
Management and Budget (OMB). This proposal is not expected to have
significant impacts on antimicrobial pesticide producers and would have
no impacts on any other sector of the economy. Moreover, a number of
its provisions, including exemptions for various antimicrobial
sterilants, reduction in duplicative regulation with FDA, and mandatory
review periods for antimicrobial applications, are expected to decrease
costs and burdens currently associated with the registration of
antimicrobial pesticide products.
EPA has prepared an economic analysis of the potential costs
associated with this proposed action, which is contained in a document
entitled Regulatory Impact Analysis of the Proposed Antimicrobial
Pesticide Rules. This document is available in the public record for
this action and is summarized in this unit.
The only costs anticipated as a result of this action are the costs
of compliance with the ``sunset provision.'' Under this provision,
proposed in Sec. 152.458, registration of a public health antimicrobial
pesticide would expire every 5 years unless the registrant certifies,
based upon efficacy and composition studies conducted within the year
prior to expiration, that the product continues to meet the standards
for registration. The studies required are an analysis of the product
composition to confirm certified limits of the ingredients, and
efficacy studies for each public health claim on the product labeling.
The costs of the analysis and certified limits determination are
estimated to be approximately $6,100 per product. The average cost of
the efficacy studies is estimated to be just under $25,500 per product,
based upon an average of six efficacy tests per product. The average
annualized testing cost per product is $5,620. However, while all
public health products would be subject to product analysis testing,
only about 61% of products would be subject to efficacy testing,
because some products can rely on testing developed for substantially
similar products. Accordingly the adjusted annualized testing cost for
products expected to actually have to conduct the testing is $3,897.
The total annualized cost for both existing and new products is
estimated to be $12.3 million.
In neither case are these costs expected to result in additional
capital costs to applicants because such studies are currently required
of applicants for registration, whether conducted by the applicants
themselves, or, more typically, contracted for with outside
laboratories.
The assumptions used in the analysis result in an overstatement of
the costs of the rule, for the following reasons:
1. The analysis assumes that the testing requirement imposes costs
effective immediately upon promulgation in 1999. However, actual costs
will be imposed only as products are submitted for new or amended
registration or reregistration over the next several years, on a
schedule that EPA cannot predict. For a product first registered,
amended or reregistered in 1999, the testing cost would be imposed only
in the fourth year of registration (2003).
2. The analysis assumed that no firms were already complying with
the sunset provisions that would be imposed. Based upon consultation
with a limited number of small businesses, EPA estimates that
approximately 11% of firms currently conduct testing that would comply
fully, and others conduct testing that would comply partially. It is
likely that a higher percentage of large firms would already be fully
or partially complying.
All other provisions of this proposal would reduce the costs of
compliance with FIFRA for producers of antimicrobial pesticides.
Provisions that reduce costs include increased opportunities for
notification instead of amendment of registration, elimination of dual
jurisdiction with FDA, exemption of certain antimicrobial products from
FIFRA regulation, more precise and clearer application and labeling
information, and mandatory review periods for antimicrobial
applications that are shorter than historical review times.
B. Regulatory Flexibility Act
Under section 605(b) of the Regulatory Flexibility Act (5 U.S.C.
601 et seq.), the Agency hereby certifies that this proposed action, if
promulgated as proposed, action will not have a significant economic
impact on a substantial number of small entities. The factual basis for
this determination is contained in the Economic Analysis referenced in
Unit XXI.A., and summarized in this unit. The only provisions in this
proposal that would impose costs on any business, including small
businesses, are the sunset provisions, discussed in Unit XXI.A.
For the purpose of analyzing potential impacts on small entities,
EPA used the RFA definition of small entities in section 601(6) of the
RFA. Under this section, small entities include small governments,
small nonprofit organizations, and small businesses. Because EPA does
not believe that governments or nonprofit organizations are likely to
be burdened by this proposed rule, EPA's analysis presents only the
estimated potential impacts on small businesses.
Table 7 below summarizes the results of EPA's analysis.
Table 7.--Impacts on Small Businesses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Level of Impact1 Percent of Small Firms Impacted Number of Small Firms Impacted2
--------------------------------------------------------------------------------------------------------------------------------------------------------
>1%3 16.4% 139
>3% 4.6% 39
>10% 0.7% 6
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 Calculated as a percentage of Annual Sales Revenue.
2 Calculated on the basis of 848 small businesses registering antimicrobial products.
3 The totals are cumulative, that is, the >3% and >10% values are included in the >1% totals.
EPA believes that all costs and burdens of this proposed rule are
attributable to the ``sunset provision'' requiring periodic efficacy
retesting and analysis of products after registration. In preparing for
today's proposal, EPA conducted discussions with all segments of the
industry, including small business (see discussion in Unit XVIII.A.),
and we have adopted many of their suggestions to minimize burden. We
invite comment on whether there are additional accommodations specific
to the sunset provision that the Agency
[[Page 50711]]
should consider to further reduce the burden on small businesses.
Based on consultation with the regulated community, EPA believes
that all other provisions would be both beneficial and cost-efficient
to all segments of the antimicrobial industry, including small
business. Specifically, EPA believes that there are overall reduced
paperwork burdens and costs associated with increased notifications and
exemptions from FIFRA; increased flexibility for applicants due to the
many opportunities for informal consultations, rebuttals, and
negotiations; greater clarity in the requirements for antimicrobial
registration and product labeling; and cost savings for individual
firms in obtaining registrations within the shortened review periods,
allowing earlier entry into the market. We invite comment on whether
there are additional accommodations we should consider that might
further facilitate the registration process for small businesses.
Are there costs or burdens, efficiencies or savings attributable to
this proposed rule that you believe have not been adequately identified
and addressed? What are they and how great are these burdens or
efficiencies? If you have a proposal for additional accommmodations to
small business, please explain what you are proposing and provide
information on costs or benefits of your approach.
For a discussion of the Agency's outreach to the antimicrobial
industry, including small businesses, and changes to this proposal
resulting from input by industry, including small businesses, refer to
Unit XVIII.A.
Since the Agency's economic analysis for this proposal estimates
that 83% of all antimicrobial registrants are small businesses, EPA is
particularly interested in receiving comment from small businesses as
to the benefits, costs, and impacts of this proposed rule.
Information relating to EPA's certification is provided upon
request to the Chief Counsel for Advocacy of the Small Business
Administration, and is included in the docket for this rulemaking. Any
comments regarding the economic impacts that this proposed regulatory
action may impose on small entities should be submitted to the Agency
at the address listed in ADDRESSES.
C. Unfunded Mandates Reform Act
Under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA)
(Public Law 104-4), EPA has determined that this action does not
contain a Federal mandate that may result in expenditures of $100
million or more for State, local, and tribal governments, in the
aggregate, or the private sector in any 1 year. The costs associated
with this action are described in the Executive Order 12866 section
above. In addition, EPA has determined that the proposed rule will not
significantly or uniquely affect small governments and does not contain
a significant Federal intergovermental mandate. As such, this action is
not subject to sections 202, 203, 204 or 205 of UMRA.
D. Consultation and Coordination with Indian Tribal Governments
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide to OMB, in a separately
identified section of the preamble to the rule, a description of the
extent of EPA's prior consultation with representatives of affected
tribal governments, a summary of the nature of their concerns, and a
statement supporting the need to issue the regulation. In addition,
Executive Order 13084 requires EPA to develop an effective process
permitting elected and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Tribal governments would not be subject to the requirements of
today's proposal. In addition, for the most part, today's proposal
implements requirements specifically set forth by the Congress in FIFRA
without the exercise of any discretion by EPA. The remainder of today's
proposal does not significantly or uniquely affect the communities of
Indian tribal governments. Accordingly, the requirements of section
3(b) of Executive Order 13084 do not apply to this proposal.
E. Enhancing Intergovernmental Partnerships
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
For the most part, today's proposal implements requirements
specifically set forth by the Congress in FIFRA without the exercise of
any discretion by EPA. The remainder of today's proposal would not
impose any enforceable duties on State, local or tribal governments.
Accordingly, the requirements of section 1(a) of Executive Order 12875
do not apply to this proposal.
F. Federalism Review
The Agency has determined that this action will not have a
substantial direct effect on States, the relationship between the
Federal government and States, the distribution in power between the
Federal government and States, the responsibilities among the levels of
government, or involve the potential pre-emption of State law as
described by Executive Order 12612, entitled Federalism (52 FR 41685,
October 30, 1987).
G. Children's Health Protection
This proposed rule is not subject to Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997) because this action is not
an economically significant regulatory action as defined by Executive
Order 12866 (see section A. of this unit). This proposed rule is
procedural in nature and does not involve decisions on environmental
health risks or safety risks that may disproportionately affect
children.
[[Page 50712]]
H. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), 15 U.S.C. 272 note) directs EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or impractical. Voluntary consensus
standards are technical standards (e.g., materials specifications, test
methods, sampling procedures, etc.) that are developed or adopted by
voluntary consensus standards bodies. This proposed regulation does not
involve technical standards that would require Agency consideration of
voluntary consensus standards. EPA requests comment on this conclusion.
I. Environmental Justice
This proposed rule does not directly affect minority populations or
low-income groups. Therefore, under Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
the Agency has not considered environmental justice-related issues with
regard to the potential impacts of this action on the environmental and
health conditions in low-income and minority communities.
J. Paperwork Reduction Act
The information collection requirements contained in this proposed
rule have been submitted to OMB under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., and in accordance with the procedures at
5 CFR 1320.11. An Information Collection Request (ICR) document has
been prepared by EPA (EPA ICR No. 277.12) and a copy may be obtained
from Sandy Farmer, OP Regulatory Information Division; Environmental
Protection Agency (2137); 401 M St., SW.; Washington, DC 20460, by
calling (202) 260-2740, or electronically by sending an e-mail message
to: farmer.sandy@epa.gov. An electronic copy has also been posted with
the Federal Register notice on EPA's homepage with other information
related to this action and included in the public version of the
official record for the proposed rule. An Agency may not conduct or
sponsor, and a person is not required to respond to a collection of
information subject to OMB approval under the PRA unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations, after initial publication in the Federal Register, are
maintained in a list at 40 CFR part 9.
The annual public burden for this collection of information, which
will be submitted for approval as an addendum to the existing ICR
approved under OMB Control No. 2070-0060, is estimated to range from 1
hour to 10.4 hours per response, depending upon the activity. The cost
is estimated to range from $71.00 to $755.00 per response, again
depending on the particular response. The actual number of respondents
and the frequency of response are not known because many of the
responses are at the discretion of the respondent. However, based upon
EPA estimates, the revisions in the proposed rule would increase the
current burden by an estimated 6,395 hours and $466,740.
Under the PRA, ``burden'' means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency. For this
collection it includes the time needed to review instructions;
processing and maintaining information, and disclosing and providing
information; search data sources; complete and review the collection of
information; and transmit or otherwise disclose the information.
Comments are requested on the Agency's need for this information,
the accuracy of the provided burden estimates, and any suggested
methods for minimizing respondent burden, including through the use of
automated collection techniques. Send comments on the ICR to the EPA at
the address provided above, with a copy to the Office of Information
and Regulatory Affairs, Office of Management and Budget, 725 17th St.,
NW., Washington, DC 20503, marked ``Attention: Desk Officer for EPA.''
Please remember to include the ICR number in any correspondence. The
final rule will respond to any comments on the information collection
requirements contained in this proposal.
List of Subjects in 40 CFR Parts 152 and 156
Environmental protection, Administrative practice and procedure,
Labeling, Occupational safety and health, Pesticides and pests,
Reporting and recordkeeping requirements.
Dated: September 7, 1999.
Carol M. Browner,
Administrator.
Therefore, it is proposed that 40 CFR chapter I, subchapter E be
amended as follows:
PART 152--[AMENDED]
1. In part 152:
a. The authority citation for part 152 continues to read as
follows:
Authority: 7 U.S.C. 136-136y.
b. Section 152.1 is revised to read as follows:
Sec. 152.1 Scope.
Part 152 sets out procedures, requirements, and criteria for the
registration of pesticide products under FIFRA section 3, and for
associated regulatory activities affecting registration.
(a) Subparts A, B, C, E, F, G, I, and U of this part apply to all
products except antimicrobial products.
(b) Subparts A, B, E, F, G, I, U, and W of this part apply to
antimicrobial products.
c. Section 152.3 is amended by removing the paragraph designations
for the existing definitions, removing the definition for
``pesticide,'' revising the definitions for ``active ingredient''and
``applicant'', and adding alphabetically new definitions to read as
follows:
Sec. 152.3 Definitions.
* * * * *
Active ingredient means any substance (or group of structurally
similar substances if specified by the Agency) in a pesticide product
that will prevent, destroy, repel, or mitigate any pest, or that
functions as a plant regulator, desiccant, defoliant, or nitrogen
stabilizer.
* * * * *
Antimicrobial pesticide means a pesticide product that:
(1) Is intended to have pesticide activity against microbiological
pests, or to protect inanimate articles, substances, industrial
processes or systems from deterioration, fouling, or contamination
caused by bacterial, viral, fungal, protozoan, algal or slime pests;
and
(2) In the intended use is exempt from or not subject to the
requirement for a tolerance under FFDCA section 408 or a food additive
regulation under FFDCA section 409.
(3) The term does not include any of the following:
(i) A wood preservative or antifouling paint that makes any non-
antimicrobial pesticidal claim (such as insecticidal), regardless of
whether it also makes an antimicrobial claim. A wood preservative that
makes only an antimicrobial claim is an antimicrobial pesticide.
(ii) A fungicide for agricultural use. A fungicide is considered to
be for agricultural use if it is intended to be applied to soil or to
growing plants before harvest. A fungicide intended for post-harvest
use is not considered to be
[[Page 50713]]
for agricultural use. ``Fungus,'' as defined in FIFRA, includes rust,
smut, mildew, mold, yeast, and bacteria.
(iii) A herbicide for aquatic use. A herbicide is considered to be
for aquatic use if it is intended to be applied directly to natural or
environmental bodies of water (such as lakes, ponds, or streams) or to
terrestrial areas bordering environmental bodies of water for control
of algae or weeds. A pesticide solely for control of algae in non-
environmental waters (such as swimming pools or industrial water
systems) is considered to be an antimicrobial pesticide and not an
aquatic herbicide.
* * * * *
Applicant means a person applying for a new registration, or a
registrant applying for an amended registration or submitting a
notification.
Application for registration means an application for new or
amended registration.
* * * * *
Complete application means an application for registration that
contains all data, forms, and information required by EPA to be
submitted with the application, and that will allow EPA to initiate
review, notwithstanding that EPA may determine that additional
information is required to approve the application. To be a complete
application, each required item, and the application as a whole, must
be determined by EPA to be complete, accurate, readable, and submitted
in the format and number of copies required by the Agency.
* * * * *
Fast-track application means an application under FIFRA section
3(c)(3).
FFDCA means the Federal Food, Drug, and Cosmetic Act, as amended
(21 U.S.C 201 et seq.).
* * * * *
Nitrogen stabilizer means any substance or mixture of substances
intended for preventing or hindering the process of nitrification,
denitrification, ammonia volatilization or urease production through
action upon soil bacteria, except that the term does not include:
(1) Dicyandiamide and ammonium thiosulfate; or
(2) Any substance or mixture of substances in commercial agronomic
use before January 1, 1992, that was not registered before January 1,
1992, and for which the seller or distributor has made no specific
claims of preventing or hindering the process of nitrification,
denitrification, ammonium volatilization or urease production after
January 1, 1992.
Registrant means a person to whom a registration has been issued.
In this part 152, if the term ``applicant'' and ``registrant'' would
both apply, the term ``applicant'' is used.
* * * * *
d. By adding new Sec. 152.6 to read as follows:
Sec. 152.6 Substances excluded from regulation by FIFRA.
Products and substances listed in this section are excluded from
FIFRA regulation if they meet the specified conditions or criteria.
(a) Liquid chemical sterilants. A liquid chemical sterilant product
is not a pesticide under FIFRA section 2(u) if it meets all of the
following criteria. Excluded products are regulated by the Food and
Drug Administration. Products excluded are those meeting all of the
following criteria:
(1) Composition. The product must be in liquid form as sold or
distributed. Pressurized gases or products in dry or semi-solid form
are not excluded by this provision. Ethylene oxide products are not
liquid products and are not exempt under this exclusion.
(2) Claims. The product must bear a sterilant claim, or a sterilant
plus subordinate level disinfection claim. Products that bear
antimicrobial claims solely at a level less than ``sterilant'' are not
excluded and are jointly regulated by EPA and FDA. ``Sterilant'' is
defined in Sec. 156.441 of this chapter.
(3) Use site. The product must be intended and labeled only for use
on ``critical or semi-critical devices.'' A ``critical device'' is any
device which is introduced directly into the human body, either into or
in contact with the bloodstream or normally sterile areas of the body.
A ``semi-critical device'' is any device which contacts intact mucous
membranes but which does not ordinarily penetrate the blood barrier or
otherwise enter normally sterile areas of the body. Liquid chemical
sterilants that bear claims solely for non-critical medical devices are
jointly regulated by EPA and FDA. Liquid chemical sterilants bearing
claims solely for use sites that are not medical devices, such as
veterinary equipment, are not excluded and are regulated by EPA.
(b) Nitrogen stabilizers. A nitrogen stabilizer is excluded from
regulation under FIFRA if it is a substance (or mixture of substances)
meeting all of the following criteria:
(1) The substance prevents or hinders the process of nitrification,
denitrification, ammonia volatilization, or urease production through
action affecting soil bacteria and is distributed and sold solely for
those purposes and no other pesticidal purposes.
(2) The substance was in ``commercial agronomic use'' in the United
States before January 1, 1992. EPA considers a substance to be in
commercial agronomic use if it is available for sale or distribution to
users for direct agronomic benefit, as opposed to limited research,
experimental, or demonstration use.
(3) The substance was not registered under FIFRA before January 1,
1992.
(4) Since January 1, 1992, the distributor or seller has made no
claim that the product prevents or hinders the process of
nitrification, denitrification, ammonia volatilization, or urease
production. EPA considers any of the following claims (or their
equivalents) to be a claim that the product prevents or hinders
nitrification, denitrification, ammonia volatilization, or urease
production:
(i) Improves crop utilization of applied nitrogen.
(ii) Reduces leaching of applied nitrogen or reduces ground water
nitrogen contamination.
(iii) Prevents nitrogen loss.
(iv) Prolongs availability of nitrogen.
(v) Increases nitrogen uptake, availability, usage, or efficiency.
(5) A product will be consider to have met the criterion of
paragraph (b)(4) of this section that no nitrogen stabilization claim
has been made if:
(i) The nitrogen stabilization claim, in whatever terms expressed,
is made solely in compliance with a State requirement to include the
claim in materials required to be submitted to a State legislative or
regulatory authority, or in the labeling or other literature
accompanying the product; and
(ii) The State requirement to include the claim was in effect both
before the product bearing the claim was introduced into commercial
agronomic use, and before the effective date of this rule.
(6) A product that meets all of the criteria of this paragraph with
respect to one State is not thereby excluded from FIFRA regulation if
distributed and sold in another State whose nitrogen stabilization
statement requirement does not meet the requirements of paragraph
(b)(5)(ii) of this section.
(c) Human drugs. Human drugs for use in or on living man are not
for use against ``pests'' as defined in FIFRA section 2(t). Human drugs
are subject to regulation by the Food and Drug Administration under the
FFDCA.
(d) Animal drugs. Viruses, bacteria or other microorganisms on or
in living animals are not ``pests'' under FIFRA section 2(t). A ``new
animal drug'' as
[[Page 50714]]
defined in section 201(w) of the FFDCA, or an animal drug that FDA has
determined is not a ``new animal drug'' is not a pesticide under FIFRA
section 2(u). Animal drugs are subject to regulation by the Food and
Drug Administration under the FFDCA.
(e) Animal feeds. An animal feed containing a new animal drug is
not a pesticide under FIFRA section 2(u). Animal feeds containg new
animal drugs are subject to regulation by the Food and Drug
Administration under the FFDCA.
(f) Vitamin hormone products. A product consisting of a mixture of
plant hormones, plant nutrients, inoculants, or soil amendments is not
a ``plant regulator'' under FIFRA section 2(v), provided it meets the
following criteria:
(1) The product, in the undiluted package concentration at which it
is distributed or sold, meets the criteria of Sec. 156.62 of this
chapter for Toxicity Category III or IV; and
(2) The product is not intended for use on food crop sites, and is
labeled accordingly.
Sec. 152.8 [Amended]
e. In Sec. 152.8, by removing paragraphs (a), (b), (c),
introductory text, (c)(2), (c)(3), and (c)(4), and redesignating
paragraph (c)(1) as paragraph (a) and redesignating paragraph (d) as
paragraph (b).
f. In Sec. 152.20, by revising paragraph (b) to read as follows:
Sec. 152.20 Exemptions for pesticides regulated by another Federal
agency.
* * * * *
(b) Non-liquid chemical sterilants. A non-liquid chemical
sterilant, except ethylene oxide, that meets the criteria of
Sec. 152.6(a)(2) with respect to its claims and Sec. 152.6(a)(3) with
respect to its use sites is exempted from regulation under FIFRA.
Sec. 152.25 [Amended]
g. Section 152.25 is amended by removing paragraph (d) and
redesignating (e) through (g) as paragraphs (d) through (f).
h. Section 152.44 is amended by removing paragraph (b)(3),
redesignating paragraph (b)(4) as paragraph (b)(3), and adding new
paragraph (c) to read as follows:
Sec. 152.44 Application for amended registration.
* * * * *
(c) A registrant may at any time submit identical minor labeling
amendments affecting a number of products as a single application if no
data are required for EPA to approve the amendment (for example, a
change in the wording of a storage statement for designated residential
use products). A consolidated application must clearly identify the
labeling modification(s) to be made (which must be identical for all
products included in the application), list the registration number of
each product for which the modification is requested, and provide
required supporting materials (for example, labeling) for each affected
product.
i. By adding new subpart W to read as follows:
Subpart W--Registration of Antimicrobial Products
Sec.
152.440 General.
152.441 Applicability.
152.442 Definitions.
152.443 Who may apply.
152.444 Alternate formulations.
152.445 Types of antimicrobial applications.
152.446 Notifications and non-notifications.
152.447 Consultation with EPA.
152.450 Contents of application.
152.451 How to submit applications.
152.455 Action on applications.
152.457 Review periods for applications.
152.458 Duration of registration.
152.459 Terms and conditions of registration.
Subpart W--Registration of Antimicrobial Products
Sec. 152.440 General.
(a) FIFRA section 3(h) requires EPA to establish by regulation
procedures for the registration of certain antimicrobial pesticide
products.
(b) In order to register, and lawfully distribute or sell, an
antimicrobial product, a wood preservative or an antifouling paint
covered by FIFRA section 3(h), an applicant must comply with each of
the following:
(1) This subpart, which describes the requirements, procedures,
conditions, and Agency review of applications for registration of
antimicrobial products. This subpart W substitutes for subpart C of
this part, which applies to all other products.
(2) Subparts A, B, E, F, G, I, and U of this part. If any provision
of subpart W conflicts with any provision of these subparts, subpart W
applies instead.
(3) Part 158 of this chapter, which describes the data requirements
for registration of antimicrobial products, wood preservatives, and
antifouling paints.
(4) Part 156 of this chapter, which describes the labeling
requirements applicable to all products. Subpart W of part 156 of this
chapter specifies efficacy performance standards and acceptable
labeling claims for antimicrobial products bearing public health
claims.
(5) Part 157 of this chapter, which establishes the criteria and
requirements for the use of child-resistant packaging.
Sec. 152.441 Applicability.
(a) This subpart applies to an application for registration of a
pesticide product that is any of the following:
(1) An antimicrobial pesticide, as defined by FIFRA section 2(mm)
and Sec. 152.3, including a wood preservative or antifouling paint
product that makes only claims of antimicrobial pesticidal activity.
All sections of this subpart apply to such products.
(2) Any product for which an antimicrobial claim is made, and which
is used in such a manner that a new or modified clearance is required
under FFDCA section 408 or 409. All sections of this subpart apply to
such products, except Sec. 152.457.
(b) This subpart does not apply to an application for registration
of a pesticide product that is any of the following:
(1) A wood preservative that makes any non-antimicrobial pesticidal
claim (for example, an insecticidal or fungicidal claim), regardless of
whether an antimicrobial claim is also made for the product.
(2) An antifoulant product that makes any non-antimicrobial
pesticidal claim, regardless of whether an antimicrobial claim is also
made for the product.
Sec. 152.442 Definitions.
Terms used in this subpart have the same definitions as in the Act
and subpart A of this part. For the purposes of this subpart, the
following terms are defined:
Clearance means any of the following:
(1) A tolerance under FFDCA section 408(b).
(2) An exemption from the requirement of a tolerance under FFDCA
section 408(c).
(3) A food additive regulation under FFDCA section 409.
(4) An approval of a medical device under FFDCA section 510(k).
Complete application means an application for registration that
contains all data, forms, and information required by EPA to be
submitted with the application, and that will allow EPA to initiate
review, notwithstanding that EPA may determine that additional
information is required to approve the application. To be a complete
application, each required item, and the application as a whole, must
be determined by EPA to be complete, accurate, readable, and submitted
in the format and number of copies required by the Agency.
[[Page 50715]]
Major new use means a new antimicrobial use of a registered active
ingredient, as used in FIFRA section 3(h).
Minor amendment means an amendment to an antimicrobial registration
that does not require the review of scientific data.
Substantive amendment means an amendment to an antimicrobial
registration that requires scientific review of data.
Sec. 152.443 Who may apply.
(a) New registration. Any person may apply for new registration of
an antimicrobial product. A person seeking a new registration for an
antimicrobial product must submit an application for registration
containing the information specified in Sec. 152.450. An application
for new registration must be approved by the Agency before the product
may lawfully be distributed or sold, except as provided by Sec. 152.30.
(b) Amended registration. (1) Any registrant may apply for
amendment of his/her registration to modify the composition, labeling,
or packaging of the product. Except as provided by Sec. 152.446, a
registrant may modify the registration only by submitting an
application for amended registration. The applicant must submit the
information specified in Sec. 152.450, as applicable to the change
requested.
(2) Except as provided by paragraph (c) of this section, the
registrant must submit a separate application for each amendment.
(3) If an application for amendment is required, the application
must be approved by the Agency before the product, as modified, may
lawfully be distributed or sold.
(c) Consolidation of amendments. A registrant may at any time
submit identical minor labeling amendments affecting a number of
products as a single application if no data are required for EPA to
approve the amendment (for example, a change in the wording of a
storage statement for designated household products). A consolidated
application must clearly identify the labeling modification(s) to be
made (which must be identical for all products), list the registration
number of each product for which the modification is requested, and
provide required supporting materials (for example, labeling) for each
affected product.
(d) Alternatives to amendment. In its discretion, the Agency may:
(1) Waive the requirement for submission of an application for
amended registration.
(2) Permit an applicant to modify a registration by notification or
non-notification in accordance with Sec. 152.446.
(e) Certification statement. In its discretion, the Agency may
permit an applicant to certify to the Agency that the applicant has
complied with an Agency directive or requirement with respect to any
element of a new or amended registration. If the Agency determines that
a requirement may be satisfied by an applicant certification, the
Agency will provide, through a guidance document available to the
general public, detailed instructions on a certification process. The
guidance document will specify the content of a certification
statement, any materials that must be submitted with the certification
or maintained by the applicant, and the manner of submission of the
certification.
Sec. 152.444 Alternate formulations.
(a) A product proposed for registration must have a single, defined
composition of active and inert ingredients, except that EPA may
approve a basic formulation and one or more alternate formulations
under a single registration.
(b) An alternate formulation must meet the criteria listed in
paragraph (b)(1) through (b)(4) of this section. The Agency may require
the submission of data to determine whether the criteria have been met.
(1) The alternate formulation must contain, and have the same
certified limits for, each active ingredient in the basic formulation.
(2) If the alternate formulation contains an inert ingredient or
impurity of toxicological significance, the formulation must have the
same upper certified limit for that substance as the basic formulation.
(3) The label text of the alternate formulation product must be
identical to that of the basic formulation.
(4) The analytical methods required under Sec. 158.180 of this
chapter must be suitable for use on both the basic formulation and the
alternate formulation.
(c) Notwithstanding the criteria in this section, the Agency may
determine that an alternate formulation must be separately registered.
If EPA makes this determination, the Agency will notify the applicant
of its determination and its reasons. Thereafter the application for an
alternate formulation will be treated as an application for new
registration.
Sec. 152.445 Types of antimicrobial applications.
The following types of applications are identified solely for
purposes of this subpart, in order to establish review periods.
Identification of application types in this section does not modify
similar terms used elsewhere in EPA regulations. Application categories
generally differ based upon factors related to the active ingredient
status, the product formulation type, the uses proposed, and whether
data are required with the application. An application may fall into
only one category, as determined by EPA.
(a) Application for registration of a food or feed use. (1) Any
application for registration that proposes a use that would require the
establishment of a new or modified clearance under the FFDCA. Under the
FFDCA, a clearance must be granted, either by EPA or by FDA, for uses
that might result, directly or indirectly, in residues in raw or
processed food or animal feed.
(2) The review periods in Sec. 152.457 do not apply to applications
covered by paragraph (a)(1) of this section. Such applications require
significantly more data, require a longer review time, and are subject
to formal approval by regulation under the FFDCA.
(b) Application for new registration--(1) New active ingredient. An
application for registration of a new product containing any active
ingredient that is not contained in a currently registered product.
(2) Substantially similar product. An application for new
registration of a product that meets all of the criteria in this
paragraph.
(i) Formulation. The product formulation contains the same active
ingredients and is substantially similar in composition to a cited
currently registered product.
(ii) Uses. The proposed uses are substantially similar to the uses
on the label of the cited product. The proposed product may bear fewer
uses than the cited product, but may not bear expanded uses or
different uses or claims.
(iii) Method of data support. The application relies solely upon
data from a substantially similar registration for support (with the
exception of certain product chemistry data, which must be submitted
for all new products) and does not require the submission of efficacy
data.
(3) Identical product. An application for registration of a product
that meets both of the criteria in this paragraph.
(i) Formulation. The formulation (including inert ingredients) is
identical in composition to a cited currently registered formulation.
Typically such a product either is a currently registered formulation
that is being repackaged as a new product without separate
[[Page 50716]]
production, or is a formulation of identical composition to another
product that is being separately produced according to specifications
provided by the registrant of the cited product.
(ii) Uses and claims. The proposed uses are identical to those on
the cited product, with no deviation in use sites or directions for
use. A product may have fewer uses than on the cited product, but not
different or expanded uses or claims.
(4) New product with major new use. An application for new
registration that also proposes a ``major new use,'' as described in
paragraph (c)(1) of this section. Any application for a new
registration that proposes only an additional or different use that is
not a major new use will be considered to be a new registration
described in paragraph (b)(5) of this section.
(5) Other new product. Any application for new registration that
does not meet the criteria of paragraph (b)(1) through (b)(4) of this
section. These products usually require the submission of data.
Examples of what would be included in this category are applications
for registration of a product of any of the types listed below.
(i) The product is a formulation of different active ingredients
than is contained in any currently registered product.
(ii) The product contains the same active ingredients, but is in a
different physical form (liquid, powder) than any other registered
product containing the same active ingredients, or is not substantially
similar in composition to a cited currently registered product.
(iii) The product has any unregistered source of any active
ingredient, regardless of the fact that the active ingredient is
currently registered in another product. Use of an unregistered source
of active ingredient requires review of supporting data for the
unregistered ingredient.
(iv) The product has an additional use that is not currently
registered for any substantially similar product.
(v) The product requires the submission of efficacy data because
the formulation is not identical to another product.
(c) Amendments to registration--(1) Major new use. An application
for amended registration to add a major new use that is not currently
registered for one or more of the active ingredients in the product.
The major new use would generally be significantly different in the
manner of use and exposure to humans or the environment from other
registered use patterns for the active ingredient.
(2) Substantive amendment. An amendment that is not a major new
use, and that requires scientific review of data. These include, but
are not limited to, the following types of amendments:
(i) Any amendment that contains a data submission.
(ii) The addition of a use that has been approved for another
registered product containing the same active ingredients, but which is
not a substantially similar product as the registration for which the
amendment is sought.
(iii) Except as permitted by Sec. 152.446, Notifications and non-
notifications, a change in precautionary or other hazard statements,
use instructions, minor changes in ingredients that do not modify label
statements, change in use concentrations, method of application, or
pests.
(3) Minor amendment. An amendment to an existing registration which
does not require scientific review of any type. In no case does an
application for a minor amendment contain data for review. A minor
amendment might include, but is not limited to, changes for which EPA
must:
(i) Examine briefly or determine the applicability of previously
submitted data (without scientific evaluation of such data).
(ii) Compare composition, characteristics or labeling with other
products.
(iii) Evaluate the adequacy of the applicant's data citations or
method of support.
(iv) Determine whether an adequate basis exists for a proposed
label statement.
(v) Determine whether a proposed use is substantially similar to an
approved use for a cited substantially similar product.
Sec. 152.446 Notifications and non-notifications.
(a) Changes permitted by notification--(1) Notifications permitted
by statute. A registrant of an antimicrobial product may add relevant
information on product efficacy, product composition, container
composition or design, or other characteristics that do not relate to
pesticidal claims or activity. An example of a product efficacy claim
that does not relate to pesticidal claims or activity would be a
cleaning, deodorizing, or polishing claim.
(2) Notifications permitted by EPA. In addition, EPA may determine
that certain minor modifications to registration having no potential to
cause unreasonable adverse effects to the environment may be
accomplished by notification to the Agency, without requiring the
registrant to obtain Agency approval. If EPA so determines, it will
issue a notice to registrants describing the types of modifications
permitted by notification.
(b) Procedure for notification. All notifications must be submitted
in accordance with the procedures of this paragraph and any
supplemental notice to registrants.
(1) Submission. A registrant must submit the notification to the
Agency at least 60 days before distribution or sale of a product as
modified.
(2) Substantiation. The registrant must retain, and submit to the
Agency upon request, substantiating information or data supporting the
proposed modification. These data need not be submitted with the
notification unless specified in a notice issued in accordance with
paragraph (a)(2) of this section. The substantiating information may be
required, however, in accordance with paragraph (b)(4) of this section
if the notification is disapproved.
(3) Agency decision. Within 30 days after receipt, the Agency will
notify the registrant in writing if the notification is disapproved and
state the reasons why it is unacceptable.
(4) Objection. A registrant may file an objection to a disapproval
in writing not later than 30 days after receipt of the Agency's
disapproval. If the basis for the disapproval is that substantiating
information is needed, the registrant must submit such information as
part of the objection. A decision by EPA after receipt and
consideration of an objection is a final agency action.
(5) Distribution or sale. A registrant may not distribute or sell a
product for which a modification by notification is proposed until the
registrant receives EPA notice of approval, or until 60 days after
submission of the notification, whichever comes first. A registrant may
not sell or distribute a product bearing a disapproved modification.
(c) Changes permitted without notification. EPA may determine that
certain minor changes to registration having no potential to cause
unreasonable adverse effects to the environment may be accomplished
without notification to or approval by the Agency. If EPA so
determines, it will issue a notice to registrants describing the types
of changes permitted without notification (known as non-notifications).
A registrant may distribute or sell a product changed as permitted by
such notice without notification to or approval by the Agency.
(d) Effect of non-compliance. Notwithstanding any other provision
of
[[Page 50717]]
this section, if the Agency determines that a product has been modified
through notification or without notification in a manner inconsistent
with paragraphs (a) through (c) of this section or any notice issued
thereunder, EPA may initiate regulatory or enforcement action, or both,
without first providing the registrant with an opportunity to submit an
application for amended registration.
Sec. 152.447 Consultation with EPA.
(a) Optional consultation. An applicant may consult the Agency at
any time prior to submitting an application. Consultations should be by
the most efficient and least time-consuming method available that
satisfies the applicant's need. For minor questions or guidance, fax
and e-mail are preferred, so that the Agency may respond both rapidly
and in writing.
(b) Meetings. If a meeting is desired, applicants should contact
the appropriate team leader or Branch Chief and provide a proposed
agenda, list of likely attendees, and requested date(s). If EPA agrees
that a meeting would be productive, EPA will schedule the meeting,
honoring the applicant's requested times insofar as practicable, and
will invite needed Agency personnel. EPA may choose not to meet with
applicants if matters can be resolved by other means.
(c) Required consultation. An applicant must consult the Agency
before submitting an application for registration if:
(1) The application is for a new chemical or major new use. It is
strongly recommended that this consultation be a meeting or conference
call with written confirmation of any agreements.
(2) The applicant wishes to develop data using different or
modified protocols for required efficacy studies, or if no test method
is specified. In some cases, EPA approval of alternate protocols and
test standards is required. Consultation would typically consist of a
written explanation of the modifications proposed or the proposed
protocol, which EPA would approve in writing.
(d) Written determinations. An applicant may rely upon regulatory
determinations only if in writing from EPA.
(e) Reliance on EPA determinations. EPA will not change the
regulatory decisions contained in a written determination issued under
paragraph (d) of this section unless:
(1) EPA concludes that its determination was in error.
(2) The applicant modifies the circumstances upon which the
determination was based or EPA determines that the circumstances are
other than described by the applicant.
(3) The applicant fails to submit the application in a timely
manner, such that EPA's determination no longer comports with Agency
regulations or policy; or
(4) EPA has information that raises concerns that an unreasonable
adverse effect on the environment may result unless it changes its
determination.
Sec. 152.450 Contents of application.
Each application for registration must include the data,
information, and forms listed in this section.
(a) Application for registration. The applicant must submit an
application form provided by the Agency. The application form is
required for all applications, both new and amended, as well as for
notifications under Sec. 152.446. To be complete:
(1) The applicable parts of the form must be properly and
accurately filled in, according to the instructions provided with the
form.
(2) The applicant must identify on the form which type of
application the applicant believes is being submitted for purposes of
review time computation. Types of applications are listed in
Sec. 152.445.
(3) If the application relies on an ``identical'' or
``substantially similar'' product, the applicant must provide the EPA
Registration Number of the product claimed as identical or
substantially similar.
(4) The form must be signed by an authorized representative of the
applicant and must be dated.
(b) Authorization for agent. The applicant must submit a letter of
authorization designating an agent residing in the United States if the
applicant is located outside of the United States or if the applicant
wishes to use an agent. To be complete, the authorization must:
(1) Be on the applicant's company letterhead.
(2) Provide identifying information for the agent, including name,
address, and telephone numbers (fax and e-mail are requested if
available).
(3) Affirm that the person designated is authorized to serve as
agent with respect to specified applications or registrations and
provide a clear description of the products or applications covered and
any limitations on the authorization.
(4) Be signed (with name and title) by an authorized representative
of the applicant and be dated.
(c) Summary of application. An application for registration must
contain a publicly releasable summary of the application, including a
list of the data submitted or cited in support of the application,
together with a brief summary of the results of any studies submitted.
This summary may be combined with that required for any other purpose.
(d) Statement of Formula. (1) The applicant must submit a Statement
of Formula that identifies the composition of the product proposed for
registration. A Statement of Formula is required for:
(i) Each application for new registration.
(ii) Each application for amended registration that proposes any
change in the product composition or a change in other information on
the previous Statement of Formula.
(iii) Each notification under Sec. 152.446 which affects the
composition of the product.
(2) To be complete, the Statement of Formula must be accurately
filled out with all required information, and must be signed by an
authorized representative of the applicant.
(e) Labeling. (1) The applicant must submit the number of copies of
draft labeling specified by the Agency. Generally four copies of draft
labeling must be submitted. Draft labeling is required for:
(i) Each application for new registration.
(ii) Each application for amended registration, if the amendment
proposes a label change or a labeling change is otherwise necessitated
by the amendment (e.g., a change in composition affecting the
labeling).
(iii) Each notification under Sec. 152.446 that modifies any
portion of the labeling.
(2) To be complete, the labeling submission must:
(i) Include both the product label and any supplemental labeling,
brochures, or other printed material that is intended to accompany the
product in distribution or sale.
(ii) In the case of an amendment to existing labeling, be identical
in wording to the last approved labeling, except for proposed changes
(and any previously accepted notification), which must be marked.
(iii) Be suitable for photocopying. In general, highlighting does
not photocopy; changes need to be marked or circled in black ink.
Product packaging bearing the labeling is not acceptable for this
purpose.
(f) Method of support documentation. The applicant must submit
documentation of the method of support that will be used to satisfy
each data requirement that applies to the
[[Page 50718]]
application. Various forms provided by the Agency must be submitted to
document the applicant's choices. This paragraph summarizes data
support requirements. The applicant must comply with subpart E of this
part, which contains detailed requirements and exceptions to the data
support process.
(1) In general, the following choices for each data requirement are
available:
(i) The applicant may submit the data. In all cases, an applicant
may submit a study that satisfies a data requirement. Typically certain
data must be submitted (product chemistry) and may not be cited. Refer
to paragraph (g) of this section for information on data submission.
(ii) The applicant may cite the data with permission or offer to
pay. If the data are exclusive use data, the applicant must have
written permission from the data submitter. If the data are subject to
compensation provisions, the applicant must have made appropriate
offers to pay to each data submitter(s). Refer to paragraph (f)(2) of
this section for the forms used to properly document citation of data.
(iii) The applicant may request in writing a waiver of the data
requirement, together with a rationale for each waiver requested. A
waiver request without a rationale is not complete.
(2) To be complete, the applicant who submits or cites data to
satisfy any data requirement must submit, as applicable, one or more of
the following:
(i) A data reference sheet (data matrix). This is a listing of all
data requirements applicable to the product, identifying the means of
satisfying each requirement, and must be submitted whenever an
applicant submits his/her own data or uses the selective method of data
support (see Sec. 152.90). To be complete, each citation of data must
include the Master Record Identification number, if known, or contain
sufficient detail (title, date of submission, name and EPA identifying
number of product) that EPA may clearly identify the item of data in
its files.
(ii) A formulator's exemption form. This form is used when the
applicant claims an exemption from certain data requirements because
the applicant produces his/her product using a purchased registered
source product. A single formulator's exemption form may be used for
all data requirements to which the exemption applies. The form must
identify the registration number of each source product.
(iii) Certification with respect to citation of data. This form is
used to certify that the applicant has complied with all requirements
pertaining to data submission and citation. The form must be submitted
with each application for registration.
(g) Data and information. (1) The applicant must satisfy data
requirements by submitting or properly citing data and information in
support of the application, unless the applicant obtains a waiver of
the data requirement, or unless EPA permits an alternate method of
satisfying data requirements (such as certification). Data requirements
are found in part 158 of this chapter.
(2) To be complete, the data submission must meet the following
criteria:
(i) Final report of study. The submission must contain a final
report of each study, including all information specified in Agency
guidance (e.g., identity of substance tested).
(ii) Summary of results of data. The application must include a
publicly releasable summary of the results of each study submitted. The
results of all studies may be consolidated into a single summary.
(iii) Format. Each study individually, and the data submission as a
whole, must conform to Agency requirements for formatting and
presentation, as specified in Sec. 158.32 of this chapter and Agency
guidance.
(iv) Confidential business information (CBI). Each study must
conform to Agency requirements in Sec. 158.33 of this chapter with
respect to identification, marking, and presentation of CBI.
(v) Certification of Good Laboratory Practice (GLP) compliance.
Each study must include a certification in accordance with Sec. 160.12
of this chapter.
(vi) Identification of studies demonstrating potential adverse
effects. Each study that meets the criteria of Sec. 158.34 of this
chapter for potential adverse effects must be identified and the
certification statement required by that section must be included. The
studies to which this requirement applies are subchronic and chronic
toxicity studies.
(h) Data or information pertaining to adverse effects. An applicant
must submit any factual information regarding unreasonable adverse
effects of this pesticide on man or the environment. The information
that must be submitted is that which would be required to be reported
under FIFRA section 6(a)(2) if the product were registered (see part
159 of this chapter). This requirement applies to each application for
new registration. The requirement does not apply to an application for
amended registration. To be complete, submission of adverse effects
information must be in accordance with part 159 of this chapter.
(i) Food use clearance. If the application proposes a use of the
pesticide on food or feed crops, or if the intended use of the
pesticide results or may be expected to result, directly or indirectly,
in pesticide chemical residues in or on food or feed, the applicant
must submit one of the following:
(1) A citation to each clearance that covers the proposed food or
feed use(s).
(2) A petition under FFDCA section 408 requesting the establishment
of a food clearance for each ingredient for which there is no current
clearance. Requirements for pesticide petitions are contained in 40 CFR
part 180. If a petition is required, an application for registration is
not complete unless all requirements for the petition are satisfied.
(3) Evidence of acceptance of a petition for a food additive
regulation by the FDA, if a food additive regulation is required. A
copy of the notice of filing of the petition in the Federal Register is
acceptable for this purpose.
(j) Documentation of pre-submission consultation. If a pre-
submission consultation is required by Sec. 152.447, the applicant must
submit written documentation that the consultation took place, and a
copy of any resulting regulatory decisions regarding the application or
its review (for example, agreement as to the type of application being
submitted, or specific data requirements imposed or waived).
(k) Data reviews conducted by other regulatory authorities. The
applicant must state whether the data supporting the application have
been, or are being, reviewed by State, Federal, or other national
regulatory authorities. If so, the applicant must identify the
reviewing authority and purpose of the review and must submit any
available data reviews conducted by such regulatory authorities that
are in the applicant's possession. The applicant is not required to
obtain regulatory reviews for this purpose.
(l) Other clearances. If the applicant is required to obtain
clearances or approvals from other Federal (not State) agencies before
a product may be distributed and sold, or used as proposed on the
label, the applicant must submit either:
(1) A copy of each such clearance or approval if already obtained;
or
(2) A copy of a request to the appropriate agency for each such
clearance or approval.
(m) Packaging--(1) Child-resistant packaging (CRP). If the product
is
[[Page 50719]]
required by part 157 of this chapter to be distributed and sold only in
CRP, or if the product will be sold in CRP, the applicant must submit a
certification statement that the product meets the criteria for CRP in
Sec. 157.32 of this chapter.
(2) In no case is actual product packaging to be submitted with an
application for registration. If EPA needs to evaluate the actual
product packaging, it will request submission.
(n) Product samples. In no case is a sample of the product to be
submitted with an application. Product or ingredient samples may be
required by the Agency for various purposes, but will be requested
separately and must be submitted to the address in the request.
(o) Self-addressed notice for completeness determination. (1) An
applicant may (but is not required to) provide a postcard (preferred)
or form letter that EPA may use for notification of receipt of an
application that EPA has preliminarily determined is complete.
(2) A postcard or form letter for this purpose must be addressed to
the applicant at his/her address of record, stamped with sufficient
U.S. postage, and provide a means (checkoff, space, box) for EPA to
record the registration number or file symbol of the application, the
fact that the application is complete, the date of EPA receipt, and the
expected date for decision based upon the type of application.
(3) If a means of notifying the applicant is not provided, EPA will
not otherwise notify an applicant in writing that the application is
complete. EPA may, but is not required to, telephone or e-mail an
applicant who does not provide written means of notification.
(p) Fees. If fees are required to be submitted for any application,
or in conjunction with a petition for a clearance associated with an
application, such fees must be submitted in accordance with Agency
guidance. An application is not complete unless required fees have been
submitted.
(q) Authorizations. (1) The applicant is requested, but not
required, to provide authorization for EPA to share studies submitted
by the applicant, or EPA's reviews of such studies, with other
regulatory authorities, including Federal, State, or national bodies
that may regulate pesticides. Such authorization would apply only to
the exchange of data or EPA reviews of data that might contain
Confidential Business Information (CBI) or information protected under
FIFRA section 10(g), unless the applicant provided a broader disclosure
authorization.
(2) If the applicant chooses to authorize any degree of data/review
sharing, the applicant should include with his/her application, on
company letterhead and signed by an authorized representative of the
applicant, one of the following:
(i) A blanket authorization for EPA to exchange data or EPA data
reviews pertaining to all of the applicant's products.
(ii) A specific authorization for EPA to exchange data or EPA data
reviews pertaining to an ingredient(s) or product(s) designated in the
authorization.
(iii) A specific authorization for EPA to exchange data or EPA data
reviews pertaining to data submitted with the application.
(iv) Any other form of authorization, identifying the ingredients,
products or data to which the authorization pertains and limitations
upon the authorization.
(3) If an applicant chooses not to authorize EPA data/review
sharing at the time of application, EPA may, in its discretion,
disclose data or reviews in those circumstances where no authorization
is needed, and seek consent for disclosure where needed on a case-by-
case basis.
Sec. 152.451 How to submit applications.
(a) Applications must be submitted to the Agency by U.S. mail,
courier service, or in person. EPA provides in guidance documents or
upon request the appropriate address for each type of delivery.
Applications may not be submitted electronically or by fax.
(b) EPA will not automatically provide evidence of receipt of an
application. An applicant who wishes confirmation of delivery to EPA
should use certified mail or courier services that provide
confirmation.
Sec. 152.455 Action on applications.
(a) Incomplete application. EPA will screen each application for
completeness, as specified in Sec. 152.450. If EPA determines that the
application is not complete, EPA will notify the applicant in writing
of the deficiency(ies) in the application. EPA will not place into
review, or compute review periods, for any application it finds
incomplete.
(b) Preliminary determination of complete application. If EPA makes
a preliminary determination that the application is complete, it will
place the application into review. The appropriate review period in
Sec. 152.457 will be computed from the date of receipt by EPA of the
last item that completes the application.
(c) EPA review of application. EPA will review each application for
which a preliminary determination of completeness has been made. EPA
will notify the applicant in writing of its decision on the application
upon completion of all required reviews. EPA may, in its discretion,
communicate with the applicant informally on the progress and interim
results of the review. Such informal communications do not constitute a
decision on the application, and do not affect the review period.
(d) Decision on application. When all reviews are completed, EPA
will take one of the following actions on the application:
(1) Approve the application. (i) EPA will approve an application
for registration if it meets the criteria of Sec. 152.112,
Sec. 152.113, or Sec. 152.114, as applicable.
(ii) If EPA approves the application, EPA will issue a Notice of
Registration and provide the applicant a copy of the stamped approved
labeling, together with any labeling modifications that must be made.
Before distributing or selling the pesticide product, the applicant
must submit final printed labeling to the Agency, modified as specified
by EPA in approving the registration and in the number of copies
required by EPA. Thereafter, the registrant may distribute and sell the
product under the terms approved by EPA.
(iii) If EPA approves the application for a product on terms that
differ from those requested by the applicant, the applicant may file a
written objection and request that EPA reconsider the terms that are
objectionable. An objection must be filed within 30 days of the date on
which EPA approved the application, and must set out in detail the
basis of the objection and the alternative terms of registration
requested. The applicant may not distribute or sell the product until
the objection is resolved. EPA will use its best efforts to respond
within 45 days of receipt of a timely, written objection.
(2) Determine that the application remains incomplete. EPA may
determine that, notwithstanding its preliminary determination of
completeness, the application remains incomplete. If EPA so determines,
it will notify the applicant of the deficiencies in the application.
The applicant's resubmission will be treated in accordance with either
paragraph (d)(2)(i) or (d)(2)(ii) of this section.
(i) Qualifying resubmission. EPA will treat a complete and timely
response
[[Page 50720]]
from the applicant as a ``qualifying resubmission'' subject to the
review period in Sec. 152.457(e), and will make a final decision on the
application without recomputing a full second review period provided by
Sec. 152.457(c) or (d), if:
(A) The original application has a review period of 120
days;
(B) EPA determines, in its sole discretion, that the deficiency is
less serious; and
(C) The deficiency is corrected within 30 days of receipt of EPA's
notice to the applicant.
(ii) Non-qualifying resubmission. EPA will recompute a second full
review period beginning on the date of receipt of the last item
completing the application, and will make a final decision on the
application within the review periods in Sec. 152.457(c) or (d), as
applicable, if:
(A) The original application has a review period of >120 days;
(B) EPA determines, in its sole discretion, that the deficiency is
serious; or
(C) The applicant does not respond within 30 days.
(3) Determine that the applicant has not supplied all data or
information required to determine the acceptability of the
registration. EPA may determine that, despite its preliminary
determination of completeness, the applicant has not supplied
sufficient information to issue a registration decision. If EPA so
determines, it will notify the applicant, identify the additional
information or data needed, and require that the applicant submit, by a
specified date, the information or data needed. As of the date of EPA's
notification to the applicant, the review period will stop. The elapsed
time between date of notification and receipt of response will not be
counted in computing the date for a decision under Sec. 152.457. Based
upon the nature of the deficiencies, the time anticipated for the
applicant to correct the deficiencies, and the additional time needed
by EPA to review the material submitted in response to the notice of
deficiency, EPA will specify in its notification one of two review
period decisions:
(i) EPA may specify that the review period will resume as of the
date of receipt of the applicant's complete and timely response; or
(ii) EPA may specify that the review period will resume after a
specified period following receipt of the applicant's complete and
timely response.
(4) Deny the application for failure to submit required
information. If, after notification in accordance with paragraph (d)(3)
of this section, the applicant does not respond, or does not provide
all required data or information within the specified time, EPA may
deny the application in accordance with the procedures of Sec. 152.118.
These procedures provide that EPA will issue a Notice of Intent to Deny
(NOID) the application, stating the reasons and factual basis for
denial, and permit the applicant 30 days to take corrective action. The
Agency's issuance of a NOID would constitute the action required by
FIFRA section 3(h) to notify an applicant of the Agency's decision, and
the 30 days allowed for correction or other action would not be counted
in the computation of the review period. Alternatively, EPA may
determine that the application remains incomplete, in accordance with
paragraph (d)(2) of this section. In either case, any subsequent
submission will be treated as if it were an original application, and
the review period will start over upon receipt of a complete
application.
(5) Deny the application for failure to meet the registration
standard. EPA may deny an application for registration if the Agency
determines that, based upon review of a complete application and all
data required by the Act, this part and part 158 of this chapter, the
product does not meet the criteria of FIFRA section 3(c)(5) or (7), as
specified in Sec. 152.112, Sec. 152.113, or Sec. 152.114. If EPA
proposes to deny an application on this basis, the Agency will follow
the procedures of Sec. 152.118. The Agency's issuance of a NOID would
constitute the action required by FIFRA section 3(h) to notify an
applicant of the Agency's decision, and the 30 days allowed for
correction or other action would not be counted in the computation of
the review period.
Sec. 152.457 Review periods for applications.
EPA will complete review of, and make a decision on whether to
approve, each application type listed in Sec. 152.445 within the review
periods given in this section. The statutory timeframes are based upon
submission of a complete application. The process of submission is not
complete until EPA has received the application. Accordingly, review
periods are computed from the date that EPA receives the last item of
an application that it determines thereafter is a complete application.
(a) Applications involving food/feed uses. The time frames in this
section do not apply to applications involving food or feed uses that
may require a clearance under the FFDCA. EPA will attempt to review
such applications in a time commensurate with similar non-food actions,
but because these applications may require significantly more data and
more formal procedures for approval, EPA has not established any review
periods for such applications.
(b) Fast-track applications. An application that qualifies as a
fast-track application under FIFRA section 3(c)(3)(B)(i) will be
reviewed within 90 days after receipt of a complete application.
(c) Application for new registration. Except as provided in
paragraph (e) of this section, EPA will issue a decision on a complete
application for new registration within the review period listed in the
table to this paragraph.
Review Period for Applications for New Registration
------------------------------------------------------------------------
Calendar days for issuance
Type of application of decision after receipt of
a complete application
------------------------------------------------------------------------
New active ingredient product 540
------------------------------------------------------------------------
Identical or substantially similar product 90
------------------------------------------------------------------------
Product bearing a major new use 270
------------------------------------------------------------------------
Other new product 120
------------------------------------------------------------------------
(d) Application for amended registration. Except as provided in
paragraph (e) of this section, EPA will issue a decision on a complete
application for amended registration within the review period given in
the table to this paragraph.
Review Period for Applications for Amendment
------------------------------------------------------------------------
Calendar days for issuance
Type of amendment of decision after receipt of
a complete application
------------------------------------------------------------------------
Major new use amendment 270
------------------------------------------------------------------------
Minor amendment 90
------------------------------------------------------------------------
Substantive amendment 90-180
------------------------------------------------------------------------
(e) Qualifying resubmission. In the case of a qualifying
resubmission under Sec. 152.455(d)(2)(i), EPA will issue a decision on
an application of the following type within the review period given in
the table to this paragraph.
[[Page 50721]]
Review Period for Qualifying Resubmissions
------------------------------------------------------------------------
Calendar days for issuance
Resubmission of an application for-- of decision after receipt of
a complete resubmission
------------------------------------------------------------------------
Registration of an identical or 60
substantially similar product
------------------------------------------------------------------------
Registration of ``other new product'' 90
------------------------------------------------------------------------
Minor amendment 60
------------------------------------------------------------------------
(f) Applicant recourse for failure to issue decision within review
period. If EPA has not notified the applicant that the application is
approved or denied within the review period set out in this section, or
within an alternative review period agreed to by EPA and the applicant,
the applicant may seek judicial review under 5 U.S.C. 7.
Sec. 152.458 Duration of registration.
(a) Products not bearing public health claims. The registration of
a product that bears no public health claim, as defined in Sec. 156.443
of this chapter, will be effective until EPA takes action to suspend or
cancel the registration.
(b) Products bearing public health claims. The registration of a
product bearing a public health claim, as defined in Sec. 156.443 of
this chapter, will expire 5 years after the date specified in paragraph
(b)(1) or (b)(2) of this section, as applicable, unless the
requirements of paragraph (b)(3) of this section have been met. At the
end of each 5-year period thereafter, the registration will expire
unless the requirements of paragraph (b)(3) of this section have been
met with respect to the most recent 5-year period.
(1) New products. The 5-year period for products first registered
after the effective date of this rule begins on the date of
registration. EPA will incorporate the 5-year term of registration in
the notice of registration.
(2) Existing products. The 5-year period for products already
registered as of the effective date of this rule begins on the earliest
of the following dates:
(i) The date of EPA approval of the first amendment after the
effective date of this rule. EPA will incorporate the 5-year term of
registration into the letter of approval.
(ii) The date of EPA approval of reregistration of the product
under FIFRA section 4. EPA will incorporate the 5-year term of
registration into the letter of reregistration.
(iii) A date certain approximately 1 year after the effective date
of this rule.
(3) The registration will not expire if:
(i) Within 1 year before each expiration date of the registration,
the registrant completes one or more chemical analyses of the product
according to the analytical method submitted under Sec. 158.180 of this
chapter.
(ii) Within 1 year before each expiration date of the registration,
the registrant completes efficacy testing for each public health claim
on the label in accordance with the most current Agency guidelines.
(iii) No later than 90 days before each expiration of the
registration, the registrant submits to the Office of Pesticide
Programs at EPA a written certification, signed by an authorized
representative of the registrant. The registrant must certify to each
of the following:
(A) The registrant has conducted the required tests, identifying
the tests that were conducted.
(B) Each test was conducted in accordance with the most current EPA
guidelines for product composition testing and efficacy testing, and
with applicable Good Laboratory Practice standards of part 160 of this
chapter.
(C) Based upon the product composition tests, the product
composition continues to conform to the most recent Statement of
Formula approved by EPA.
(D) Based upon the efficacy testing, the product meets applicable
performance standards of part 156, subpart W, for each public health
claim made.
(E) The test results are maintained with the registrant and will be
submitted to EPA upon request.
(4) If the registration expires, the product will be deemed to be
an unregistered product. EPA will permit the continued distribution and
sale of existing stocks of the product by the registrant for 90 days
after the expiration date, and by others for 1 year after the
expiration date, unless the Administrator determines that a different
time period is needed.
Sec. 152.459 Terms and conditions of registration.
(a) General conditions. A registration shall be subject to such
terms and conditions as EPA may establish at the time of issuance,
including, but not limited to, the terms and conditions in
Sec. 152.115. Such terms and conditions will be specified in the notice
of registration or letter approving an amendment of registration.
(b) Submission of efficacy data for non-public health products.
Efficacy data for non-public health products are not generally required
to be submitted with an application for registration, but are required
to be maintained by the registrant. Upon request by EPA, the registrant
must submit the efficacy data required by part 158 for a non-public
health product. EPA will notify the registrant and allow 30 days from
date of receipt for submission of the data.
PART 156--[AMENDED]
2. In part 156:
a. The authority citation for part 156 continues to read as
follows:
Authority: 7 U.S.C. 136 - 136y.
b. In Sec. 156.10, by revising paragraph (a)(1)(vii) and removing
paragraph (h) to read as follows:
Sec. 156.10 Labeling requirements.
(a) * * *
(1) * * *
(vii) Hazard and precautionary statements as prescribed in subpart
D of this part for human and domestic animal hazards and subpart E of
this part for environmental hazards.
* * * * *
c. By adding new subpart D to read as follows:
Subpart D--Human Hazard and Precautionary Statements
Sec.
156.60 General.
156.62 Toxicity category.
156.64 Signal word.
156.66 Child hazard warning.
156.68 First aid statement.
156.70 Precautionary statements for human hazards.
156.78 Precautionary statements for physical or chemical hazards.
Subpart D--Human Hazard and Precautionary Statements
Sec. 156.60 General.
Each product is required to bear hazard and precautionary
statements for humans and for domestic animals (if applicable) as
prescribed in this subpart. Hazard statements describe the type of
hazard that may occur, while precautionary statements will either
direct or inform the user of actions to take to avoid the hazard or
mitigate its effects.
(a) Location of statements--(1) Front panel statements. The signal
word, child hazard warning, and, in certain cases, the first aid are
required to appear on the front panel of the label, and also in any
supplemental labeling intended to accompany the product in distribution
or sale.
(2) Statements elsewhere on label. Hazard and precautionary
statements
[[Page 50722]]
not required on the front panel may appear on other panels of the
label, and may be required also in supplemental labeling. These
include, but are not limited to, the human hazard and precautionary
statements, domestic animal statements if applicable, Notes to
Physician, and physical or chemical hazard statements.
(b) Placement and prominence--(1) Front panel statements. All
required front panel warning statements shall be grouped together on
the label, and shall appear with sufficient prominence relative to
other front panel text and graphic material to make them unlikely to be
overlooked under customary conditions of purchase and use. The table to
this paragraph shows the minimum type size requirements for the front
panel warning statements for various front panel sizes:
Type Sizes for Front Panel Warning Statements
------------------------------------------------------------------------
Point Size
Size of Label Front Panel ---------------------------------------
(Square Inches) Signal Word All Child Hazard
Capital Letters Warning
------------------------------------------------------------------------
5 and under 6 6
------------------------------------------------------------------------
Over 5 to 10 10 6
------------------------------------------------------------------------
Over 10 to 15 12 8
------------------------------------------------------------------------
Over 15 to 30 14 10
------------------------------------------------------------------------
Over 30 18 12
------------------------------------------------------------------------
(2) Other required statements. All other hazard and precautionary
statements must be at least 6 point type.
Sec. 156.62 Toxicity category.
This section establishes four Toxicity Categories for acute hazards
of pesticide products, Category I being the highest toxicity category.
Most human hazard, precautionary statements, and human personal
protective equipment statements are based upon the Toxicity Category of
the pesticide product as sold or distributed. In certain cases,
statements based upon the Toxicity Category of the product as diluted
for use are also permitted. A Toxicity Category is assigned for each of
five types of acute exposure, as specified in the table to this
paragraph.
Acute Toxicity Categories for Pesticide Products
----------------------------------------------------------------------------------------------------------------
Hazard Indicators I II III IV
----------------------------------------------------------------------------------------------------------------
Oral LD50 Up to and > 50 thru 500 mg/ > 500 thru 5,000 > 5,000 mg/kg
including 50 mg/ kg mg/kg
kg
----------------------------------------------------------------------------------------------------------------
Dermal LD50 Up to and > 200 thru 2,000 > 2,000 thru > 5,000 mg/kg
including 200 mg/ mg/kg 20,000 mg/kg
kg
----------------------------------------------------------------------------------------------------------------
Inhalation LC50 Up to and > 0.2 thru 2 mg/ > 2 thru 20 mg/ > 20 mg/liter
including 0.2 mg/ liter liter
liter
----------------------------------------------------------------------------------------------------------------
Eye irritation Corrosive; corneal Corneal opacity No corneal No irritation
opacity not reversible within opacity;
reversible within 7 days; irritation
7 days irritation reversible within
persisting for 7 7 days
days
----------------------------------------------------------------------------------------------------------------
Skin irritation Corrosive Severe irritation Moderate Mild or slight
at 72 hours irritation at 72 irritation at 72
hours hours
----------------------------------------------------------------------------------------------------------------
Sec. 156.64 Signal word.
(a) Requirement. Except as provided in paragraph (a)(4) of this
section, each pesticide product must bear on the front panel a signal
word, reflecting the highest Toxicity Category (Category I is the
highest toxicity category) to which the product is assigned by any of
the five routes of exposure in Sec. 156.62. The signal word must also
appear together with the heading for the human precautionary statement
section of the labeling (see Sec. 156.70).
(1) Toxicity Category I. Any pesticide product meeting the criteria
of Toxicity Category I for any route of exposure must bear on the front
panel the signal word ``DANGER.'' In addition, if the product is
assigned to Toxicity Category I on the basis of its oral, inhalation or
dermal toxicity (as distinct from skin and eye irritation), the word
``Poison'' must appear in red on a background of distinctly contrasting
color, and the skull and crossbones symbol must appear in immediate
proximity to the word ``Poison.''
(2) Toxicity Category II. Any pesticide product meeting the
criteria of Toxicity Category II as the highest category by any route
of exposure must bear on the front panel the signal word ``WARNING.''
(3) Toxicity Category III. Any pesticide product meeting the
criteria of Toxicity Category III as the highest category by any route
of exposure must bear on the front panel the signal word ``CAUTION.''
(4) Toxicity Category IV. A pesticide product meeting the criteria
of Toxicity Category IV by all routes of exposure is not required to
bear a signal word. If a signal word is used, it must be ``CAUTION.''
(b) Use of signal words. In no case may a product:
[[Page 50723]]
(1) Bear a signal word reflecting a higher Toxicity Category than
indicated by the route of exposure of highest toxicity, unless the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment;
(2) Bear a signal word reflecting a lesser Toxicity Category
associated with a diluted product. Although precautionary statements
for use dilutions may be included on label, the signal word must
reflect the toxicity of the product as distributed or sold; or
(3) Bear different signal words on different parts of the label.
Sec. 156.66 Child hazard warning.
(a) Each pesticide product must bear on the front panel of the
label the statement ``Keep Out of Reach of Children.'' The statement
must appear on a separate line in close proximity to the signal word.
The statement is required on Toxicity Category IV products that do not
otherwise require a signal word.
(b) EPA may waive the requirement, or require an alternative child
hazard warning, if:
(1) The applicant can demonstrate that the likelihood of exposure
of children to the pesticide during distribution, marketing, storage or
use is remote (for example, an industrial use product); or
(2) The pesticide is approved for use on children (for example, an
insect repellent).
(c) EPA may approve an alternative child hazard warning that more
appropriately reflects the nature of the pesticide product to which
children may be exposed (for example, an impregnated pet collar). In
this case, EPA may also approve placement on other than the front
panel.
Sec. 156.68 First aid statement.
(a) Product as sold and distributed. Each product must bear a first
aid statement if the product has systemic effects in Category I, II, or
III, or skin or eye irritation effects in Category I or II. First aid
statements are based upon the Toxicity Category by each route of
exposure for the product.
(b) Product as diluted for use. If the product labeling bears
directions for dilution with water prior to use, the label may also
include a statement describing how the first aid measures may be
modified for the diluted product. Such a statement must reflect the
Toxicity Category(ies) of the diluted product, based upon data for the
route of exposure (or calculations if appropriate). If the labeling
provides for a range of use dilutions, only that use dilution
representing the highest concentration allowed by labeling may be used
as the basis for a statement pertaining to the diluted product. The
statement for a diluted product may not substitute for the statement
for the concentrate, but augments the information provided for the
concentrate.
(c) Heading. The heading of the statement must be ``First Aid.''
(d) Location of first aid statement. The first aid statement must
appear on the front panel of the label of all products assigned to
Toxicity Category I by any route of exposure. Upon review, the Agency
may permit reasonable variations in the placement of the first aid
statement if a reference such as ``See first aid statement on back
panel'' appears on the front panel. The first aid statement for
products assigned to Toxicity Categories II or III may appear on any
panel of the label.
Sec. 156.70 Precautionary statements for human hazards.
(a) Requirement. Human hazard and precautionary statements as
required must appear together on the label or labeling under the
general heading ``Precautionary Statements'' and under appropriate
subheadings similar to ``Humans and domestic animals,'' ``Environmental
hazards'' (see subpart E of this part) and ``Physical or chemical
hazards.'' The phrase ``and domestic animals'' may be omitted from the
heading if domestic animals will not be exposed to the product.
(b) Content of statements. When data or other information show that
an acute hazard may exist to humans or domestic animals, the label must
bear precautionary statements describing the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid accident,
injury or toxic effect or to mitigate the effect. The precautionary
paragraph must be immediately preceded by the appropriate signal word.
(c) Typical precautionary statements. The table to this paragraph
presents typical hazard and precautionary statements. Specific
statements pertaining to the hazards of the product and its uses must
be approved by the Agency. With Agency approval, statements may be
augmented to reflect the hazards and precautions associated with the
product as diluted for use. Refer to Sec. 156.68(b) for requirements
for use dilution statements.
Typical Human Hazard and Precautionary Statements
----------------------------------------------------------------------------------------------------------------
Systemic Effects (Oral, Sensitizer (There are
Toxicity Category Dermal, Inhalation Irritation Effects no categories of
Toxicity) (Skin and Eye) sensitization)
----------------------------------------------------------------------------------------------------------------
I Fatal (poisonous) if Corrosive, causes eye If product is a
swallowed [inhaled or and skin damage [or sensitizer: Prolonged
absorbed through skin irritation]. Do or frequently repeated
skin]. Do not breathe not get in eyes on skin contact may cause
vapor [dust or spray skin, or on clothing. allergic reactions in
mist]. Do not get in Wear goggles or face some individuals.
eyes, on skin, or on shield and rubber
clothing. [Front panel gloves when handling.
first aid statement Harmful or fatal if
required.] swallowed. [Front
panel first aid
statement required.]
-----------------------------------------------------------------------------------------
II May be fatal if Causes eye [and skin]
swallowed, [inhaled or irritation. Do not get
absorbed through the in eyes, on skin, or
skin]. Do not breathe on clothing. Harmful
vapors [dust or spray if swallowed.
mist]. Do not get in [Appropriate first aid
eyes, on skin, or on statement required.]
clothing. [Appropriate
first aid statement
required.]
-----------------------------------------------------------------------------------------
[[Page 50724]]
III Harmful if swallowed Avoid contact with
[inhaled or absorbed skin, eyes or
through the skin]. clothing. In case of
Avoid breathing vapors contact immediately
[dust or spray mist]. flush eyes or skin
Avoid contact with with plenty of water.
skin [eyes or Get medical attention
clothing]. if irritation
[Appropriate first aid persists.
statement required.]
-----------------------------------------------------------------------------------------
IV No precautionary No precautionary
statements required statements required.
----------------------------------------------------------------------------------------------------------------
Sec. 156.78 Precautionary statements for physical or chemical
hazards.
(a) Requirement. Warning statements on the flammability or
explosive characteristics of the pesticide product are required if a
product meets the criteria in this section. Warning statements
pertaining to other physical/chemical hazards (e.g., oxidizing
potential, conductivity, chemical reactions leading to production of
toxic substances) may be required on a case-by-case basis.
(b) Pressurized products. The table to this paragraph sets out the
required flammability label statements for pressurized products:
Flammability Statements for Pressurized Products
------------------------------------------------------------------------
Flash point/flame extension of product Required labeling statement
------------------------------------------------------------------------
Flash point at or below 20 deg.F Extremely flammable.
or Contents under pressure.
Flashback at any valve opening Keep away from fire,
sparks, and heated
surfaces. Do not puncture
or incinerate container.
Exposure to temperatures
above 130 deg.F may cause
bursting.
------------------------------------------------------------------------
Flash point > 20 deg.F to 80 deg.F Flammable. Contents under
or pressure. Keep away from
Flame extension more than 18 inches long heat, sparks and open
at a distance of 6 inches from the flame flame. Do not puncture or
incinerate container.
Exposure to temperatures
above 130 deg.F may cause
bursting.
------------------------------------------------------------------------
All other pressurized products Contents under pressure. Do
not use or store near heat
or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130
deg.F may cause bursting.
------------------------------------------------------------------------
(c) Non-pressurized products. The table to this paragraph sets out
the required flammability label statements for non-pressurized
products:
Flammability Statement for Non-Pressurized Products
------------------------------------------------------------------------
Flash point Required labeling statement
------------------------------------------------------------------------
At or below 20 deg.F Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
------------------------------------------------------------------------
Greater than 20 deg.F to 80 deg.F Flammable. Keep away from
heat and open flame.
------------------------------------------------------------------------
Greater than 80 deg.F to 150 deg.F Combustible. Do not use or
store near heat or open
flame.
------------------------------------------------------------------------
(d) Total release fogger products. (1) A ``total release fogger''
is defined as a pesticide product in a pressurized container designed
to automatically release the total contents in one operation, for the
purpose of creating a permeating fog within a confined space to deliver
the pesticide throughout the space.
(2) If a pesticide product is at total release fogger containing a
propellant with a flash point at or below 20 deg.F, then the following
special instructions must be added to the ``Physical and Chemical
Hazards'' warning statement, in addition to any flammability statement
required by paragraph (b) of this section:
This product contains a highly flammable ingredient. It may
cause a fire or explosion if not used properly. Follow the
Directions for Use on this label very carefully.
(3) A graphic symbol depicting fire, such as illustrated in this
paragraph, or an equivalent symbol, must be displayed along with the
required language adjoining the ``Physical and Chemical Hazards''
warning statement. The graphic symbol must be no smaller than twice the
size of the first character of the human hazard signal word.
[GRAPHIC] [TIFF OMITTED] TP17SE99.004
d. By adding new subpart E to read as follows:
Subpart E--Environmental Hazard and Precautionary Statements
Sec.
156.80 General.
156.85 Non-target organisms.
Subpart E--Environmental Hazard and Precautionary Statements
Sec. 156.80 General.
(a) Requirement. Each product is required to bear hazard and
precautionary statements for environmental hazards, including hazards
to non-target organisms, as prescribed in this subpart. Hazard
statements describe the type of hazard that may be present, while
precautionary statements direct or inform the user of actions to take
to avoid the hazard or mitigate its effects.
(b) Location of statements. Environmental hazard and precautionary
statements may appear on any panel of the label and may be
[[Page 50725]]
required also in supplemental labeling. The environmental hazard
statements must appear together under the heading ``Environmental
hazards.'' Typically the statements are grouped as a sub-category
within the ``Precautionary Statements'' section of the labeling.
(c) Type size. All environmental hazard and precautionary
statements must be at least 6 point type.
Sec. 156.85 Non-target organisms.
(a) Requirement. Where a hazard exists to non-target organisms, EPA
may require precautionary statements of the nature of the hazard and
the appropriate precautions to avoid potential accident, injury, or
damage.
(b) Examples. The statements in this paragraph illustrate the types
of hazard statements that EPA may require and the circumstances under
which they are typically required. These statements are not
comprehensive; other statements may be required if more appropriate to
the formulation or use.
(1) If a pesticide intended for outdoor use contains an active
ingredient with a mammalian acute oral LD50 of 100 mg/kg or
less, the statement, ``This pesticide is toxic to wildlife'' is
required.
(2) If a pesticide intended for outdoor use contains an active
ingredient with a fish acute LC50 of 1 ppm or less, the
statement, ``This pesticide is toxic to fish'' is required.
(3) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD50 of 100 mg/kg or
less, or a subacute dietary LC50 of 500 ppm or less, the
statement, ``This pesticide is toxic to wildlife'' is required.
(4) If either accident history or field studies demonstrate that
the use of the pesticide may result in fatality to birds, fish or
mammals, the statement, ``This pesticide is extremely toxic to wildlife
(fish)'' is required.
(5) If a product is intended for or involves foliar application to
agricultural crops, forests or shade trees, or mosquito abatement
treatments, and contains a pesticide toxic to pollinating insects, the
label must bear appropriate label cautions.
(6) If a product is intended for outdoor use other than aquatic
applications, the label must bear the caution, ``Keep out of lakes,
ponds or streams. Do not contaminate water by cleaning of equipment or
disposal of wastes.''
e. By adding new subpart W to read as follows:
Subpart W--Public Health Claims for Antimicrobial Products
Sec.
156.440 Scope and applicability.
156.441 Definitions.
156.442 Use of terms and statements on labeling.
156.443 Public health claims.
156.444 Unacceptable statements and claims.
156.445 Sterilant claim on hard surfaces.
156.446 Disinfectant claim on hard surfaces.
156.447 Fungicidal claim on hard surfaces.
156.448 Virucidal claim on hard surfaces.
156.449 Tuberculocidal claim on hard surfaces.
156.451 Sanitizing claim on hard surfaces.
156.452 Residual self-sanitizing claim on hard surfaces.
156.453 Laundry additives.
156.454 Fabrics and textiles.
156.455 Air sanitizers.
156.456 Toilets and urinals.
156.457 Human drinking water.
156.458 Swimming pool and spa water.
Authority: 7 U.S.C. 136-136y.
Sec. 156.440 Scope and applicability.
(a) Scope--(1) Performance standards. This subpart establishes
performance standards for antimicrobial public health claims. The
performance standards are based upon required efficacy testing for
antimicrobial products specified in part 158 of this chapter. Test
methods and standards, evaluation procedures and reporting standards
referred to in this subpart are contained in the Pesticide Assessment
Guidelines, Subdivision G. This subpart does not cover performance
standards for non-public health claims.
(2) Acceptable public health claim. This subpart describes public
health claims that may be made on antimicrobial product labeling based
upon efficacy performance standards. This subpart also establishes
limitations on the use of certain claims, as well as specific
antimicrobial claims that are not acceptable on product labeling. An
antimicrobial public health product that does not meet the performance
standard in this subpart for a public health claim may not bear that
claim.
(3) Use directions. This subpart describes certain use directions
associated with public health claims, which are necessary to ensure
that the product will achieve the level of antimicrobial performance
claimed. This subpart does not set out use directions for non-public
health antimicrobial products, nor does it describe comprehensively the
use directions for public health products or claims, which are specific
to the use sites and patterns. Additional detailed guidance on use
directions for antimicrobial products is provided in the Pesticide
Assessment Guidelines, Subdivision H.
(b) Applicability. (1) This subpart applies to any antimicrobial
product that is subject to the provisions of part 152, subpart W, and
that makes a public health claim.
(2) This subpart applies to end use antimicrobial products. This
subpart does not apply to manufacturing use products.
Sec. 156.441 Definitions.
Terms defined in FIFRA and part 152 of this chapter are used with
the same definitions as given therein. In addition, the following terms
are defined for the purposes of this subpart:
Disinfectant means a substance that destroys or eliminates a
specific species of infectious or other public health microorganism,
but not necessarily bacterial spores, in the inanimate environment.
Equivalent, when used with respect to a test protocol or method,
means a test protocol or method, validated by multiple laboratory
studies and approved by EPA, that accomplishes the purposes intended by
the cited Guidelines test protocols, and that is expected to provide
data of equal quality and completeness as data derived from testing
according to an EPA Guideline protocol.
Fungicide means a substance that destroys fungi (including yeasts)
and fungal spores pathogenic to man or other animals in the inanimate
environment.
Guidelines means the Pesticide Assessment Guidelines, Subdivision G
- Product Performance Test Guidelines, or the Harmonized OPPTS Test
Guidelines, which are an updated, reformatted compilation of guidelines
used for both pesticide and other chemical testing.
Microbiological water purifier means any unit, water treatment
product or system that removes, kills or inactivates all types of
disease-causing microorganisms from the water, including bacteria,
viruses and protozoan cysts, so as to render the treated water safe for
drinking.
Public health product means an antimicrobial product that bears a
public health claim as defined in Sec. 156.443. A public health product
is also a ``public health pesticide'' as defined by FIFRA section
2(nn).
Sanitizer means a substance that reduces the bacterial population
in the inanimate environment by significant numbers, but does not
destroy or eliminate all bacteria or other microorganisms.
[[Page 50726]]
Sterilant means a substance that destroys or eliminates all forms
of microbial life in the inanimate environment, including all forms of
vegetative bacteria, bacterial spores, fungi, fungal spores, and
viruses. For purposes of this subpart, ``sporicide'' and ``sterilant''
are synonymous.
Tuberculocide means a substance that destroys or irreversibly
inactivates tubercle bacilli in the inanimate environment.
Virucide means a substance that destroys or inactivates viruses in
the inanimate environment.
Sec. 156.442 Use of terms and statements on labeling.
When this subpart authorizes the use of a term on product labeling,
other grammatical variants, phrases and statements having the same or
equivalent connotation are also authorized, unless EPA, on a case-by-
case basis, prohibits their use. For example, authorization to use the
term ``sterilant'' also means that ``sterilizer,'' ``sterilization,''
and similar terms may be used. EPA approves the content of each label,
and may, in its discretion, limit the use of certain terms, phrases or
statements.
Sec. 156.443 Public health claims.
EPA will consider a product to make a public health claim if any of
the following applies:
(a) A claim is made for control of specific microorganisms or
classes of microorganisms that are directly or indirectly infectious or
pathogenic to man (or both man and animals). Examples of specific
microorganisms include Mycobacterium tuberculosis, Pseudomonas
aeruginosa, E. coli, HIV, Streptococcus, and Staphylococcus aureus.
Claims for control of microorganisms infectious or pathogenic only to
animals (such as canine distemper virus or hog cholera virus) are not
considered public health claims.
(b) A claim is made for the product as a sterilant, disinfectant,
virucide, or sanitizer, regardless of the site of use of the product,
and regardless of whether specific microorganisms are identified.
(c) A claim is made for the product as a fungicide against fungi
infectious or pathogenic to man, or the product does not clearly
indicate it is intended for use only against non-public health fungi.
(d) A claim is made for the product as a microbiological water
purifier (see Sec. 156.457).
(e) A non-specific claim is made that the product will beneficially
impact or affect public health at the site of use or in the environment
in which applied (such as a ``sanitary'' claim), and:
(1) The product contains one or more ingredients that, under the
criteria in 40 CFR 153.125(a), is considered an active ingredient with
respect to a public health microorganism and there is no other
functional purpose for the ingredient in the product; or
(2) The product is similar in composition to registered products
that make explicit antimicrobial public health claims.
Sec. 156.444 Unacceptable statements and claims.
No pesticide or device, including an antimicrobial pesticide
product, may bear false or misleading claims or statements (including
the name of the product). Claims or statements of the type identified
in this section are deemed to be false or misleading and are not
acceptable on antimicrobial product labeling. Effective on [date
certain - 1 year], EPA will regard an antimicrobial product bearing a
statement, claim, or product name that is unacceptable under this
section to be misbranded under FIFRA section 2(q).
(a) Statements or claims that suggest or imply greater
effectiveness because of composition, e.g., ``hospital'' strength or
grade, ``industrial strength,'' ``extra strength.''
(b) Statements or claims that suggest or imply that the product can
or will prevent or control disease or offer health protection. Claims
such as ``prevents infection,'' ``controls infection'' or ``prevents
cross-infection'' or that the product will control or mitigate any
disease (such as Legionnaire's disease), infection, or pathological
condition constitute drug claims regulated by the Food and Drug
Administration. A claim that the product ``controls cross-contamination
from treated surfaces,'' or ``kills [name of specific organism] in the
inanimate environment'' is acceptable.
(c) Statements or claims that are overly broad, non-specific,
ambiguous or exaggerated.
(1) The terms ``microbicide'' and ``microbistat'' are not
acceptable on a public health product. If used on a non-public health
product, the claim must be qualified to indicate that the product does
not provide public health protection.
(2) The term ``biocide'' is unacceptable on a public health product
because it implies that the product can kill all living organisms,
including plants and animals. If used on a non-public health product,
the term must be qualified by directions for use or other statements
that make clear the types of organisms to be controlled.
(3) The term ``antibacterial'' or ``germicidal'' is not acceptable
on a non-public health product. If used on a public health product, the
labeling must identify the specific organisms to be controlled.
(4) The term ``antimicrobial'' is not acceptable on a non-public
health product, unless clearly and properly qualified to indicate that
the product does not provide public health protection. ``Clearly and
properly qualified'' means, at a minimum, that:
(i) The term ``antimicrobial'' is clearly associated with, and in
close proximity to, its qualifying statement on the labeling. It is
always unacceptable for the term ``antimicrobial'' to appear on a
different label panel from its qualifying statement.
(ii) The term ``antimicrobial'' is not highlighted or given
prominence over the qualifying statement by means of placement or
presentation (e.g., type size, style, color or contrast).
(iii) The term ``antimicrobial'' is not part of the product name.
(5) The prefix ``steri-'' implies sterilant activity, and may not
be used in the product name or on a product that is not a sterilant.
(6) Statements or claims implying indefinite or all-encompassing
antimicrobial protection against bacteria, fungi or algae (``germ-
free,'' ``mildew-proof,'' ``algae-free'') are not acceptable.
(d) Claims or statements that differ from or do not accurately
reflect the results demonstrated by testing.
(1) Product names, or claims or statements expressing or implying a
higher level of antimicrobial activity than that demonstrated by
testing, even if qualified (for example, ``sterisure bacteriostat'').
The labeling must unambiguously identify the level of antimicrobial
activity (disinfectant, sanitizer, etc).
(2) Claims or statements that are inconsistent with conditions of
efficacy established by testing (e.g., a claim of efficacy within 30
seconds, when testing and use directions require 2 minutes contact time
for efficacy.)
(e) Statements or claims of efficacy based on unsubstantiated,
improbable or irrelevant site/pest relationships. For example, a claim
of efficacy against a pest not likely to occur on the site (e.g.,
athlete's foot fungi in toilet bowls) is misleading.
(f) A statement or claim of presumptive or screening efficacy, even
if qualified, is not acceptable on an end use product. Presumptive
efficacy testing is intended to demonstrate that an active ingredient
is capable of antimicrobial efficacy, but such testing is not conducted
under specific conditions of use. An end use product
[[Page 50727]]
must be tested for, demonstrate, and be labeled for a specific level of
antimicrobial efficacy against identified organisms under conditions of
use likely to be encountered.
(1) Legionnaire's disease claims in cooling tower water are not
acceptable. Express or implied claims that a product will prevent
growth or spread of Legionnaire's Disease bacteria (LDB) are
unacceptable. Product labeling may provide accurate information
concerning current knowledge and recommendations of the Public Health
Service, or laboratory test data showing presumptive effectiveness of
the product against pure cultures of LDB. Such information must be
qualified by statements to the effect that findings are presumptive,
and that there is no evidence that chemical treatment will control LDB
growth under actual use conditions, reduce transmission of LDB, or
prevent Legionnaire's Disease.
(2) No statement of phenol coefficient may appear on a public
health end use product. The phenol coefficient is a calculated
comparison of presumptive efficacy.
(g) Certain symbols, icons, or graphics are unacceptable.
(1) The caduceus symbol is not acceptable because it is a medical
symbol that implies endorsement by the medical profession or broad
medical significance or health protection that is not acceptable in
accordance with paragraph (b) of this section.
(2) The name and symbol of the Red Cross are not permitted on any
product.
Sec. 156.445 Sterilant claim on hard surfaces.
(a) Performance standard. (1) When tested in accordance with the
test methods and standards in OPPTS 810.2100(b)(1) and (2) of the
guidelines or its equivalent, the product kills all test spores on all
carriers with no failures; and
(2) When tested by a laboratory independent of the registrant in
accordance with the test methods and standards in OPPTS 810.2100(b)(4)
of the guidelines or its equivalent, the product kills all test spores
on all carriers with no failures.
(b) Acceptable claim. (1) A product that meets the performance
standard in paragraph (a) may bear ``sterilant'' claims or variants of
these.
(2) Since a sterilizer by definition destroys or eliminates all
forms of microbial life, a sterilant product may bear claims of any
lesser efficacy levels, such as disinfectant, bactericidal,
tuberculocidal, fungicidal, virucidal or sanitizer. Separate directions
for use must be provided for each lesser level of antimicrobial
activity.
(c) Unacceptable claims. (1) Liquid chemical germicides may not
make sterilant claims for critical or semi-critical medical devices.
Claims for liquid chemical germicides are limited to pre-cleaning
critical or semi-critical medical devices prior to sterilization.
(2) ``One-step'' claims are not allowed for sterilants. The label
must require pre-cleaning of surfaces prior to sterilization.
Sec. 156.446 Disinfectant claim on hard surfaces.
(a) Performance standard. (1) When tested in accordance with the
test methods and standards in OPPTS 810.2100(c), (d), or (e) of the
guidelines or its equivalent, the product kills the test microorganisms
on 59 out of each set of 60 carriers/slides. Although the performance
standard is the same for all disinfectant claims, the test standards
and test microorganisms define the level of disinfectant claim that may
be made on product labeling.
(2) An applicant who wishes to make disinfectant claims for
additional microorganisms not designated in the test methods and
standards may do so based upon efficacy tests conducted with those
additional microorganisms. When tested in accordance with the test
methods and standards in OPPTS 810.2100(k) of the guidelines or its
equivalent, for each organism the product must kill all test organisms
on 10 carriers for each of two samples representing two different
batches.
(b) Acceptable limited disinfectant claim--(1) Products containing
pine oil. A product containing pine oil (as sole active ingredient or
in combination with other ingredients) and that meets the performance
standard in paragraph (a) when tested using the test standards in OPPTS
810.2100(c) of the guidelines or its equivalent and the test
microorganism Salmonella cholerasuis may bear only a claim as a
``limited disinfectant against bacteria of intestinal origin.''
(2) All other products. A product that meets the performance
standard in paragraph (a) of this section for only one major group of
microorganisms (Gram negative or Gram positive bacteria) when tested
using the test standards of OPPTS 810.2100(c) of the guidelines or its
equivalent may bear only a claim as a ``limited disinfectant.'' The
product labeling must identify the specific organisms against which the
product is effective.
(c) Acceptable general or broad spectrum disinfectant claim. A
product that meets the performance standard in paragraph (a) of this
section for both Gram negative and Gram positive bacteria when tested
using the test standards of OPPTS 810.2100(d) of the guidelines or its
equivalent may bear a claim as a ``general or broad spectrum
disinfectant,'' and may also bear a claim as a ``hard food contact
surface disinfectant.'' The product labeling must identify the specific
organisms against which the product is effective.
(d) Acceptable hospital or medical disinfectant claim. A product
that meets the performance standard in paragraph (a) of this section
when tested in accordance with the test standard in OPPTS 810.2100(e)
of the guidelines or its equivalent may bear a claim as a ``hospital or
medical environment disinfectant,'' and may also bear a claim as a
``hard food contact surface disinfectant.'' The product labeling must
identify the specific organisms against which the product is effective.
(e) Towelette disinfectant claims--(1) Single use towelette. A
single use towelette may bear a claim as a ``single use towelette for
the disinfection of hard surfaces'' if, when tested by methods and
standards approved by EPA (OPPTS 810.2100(i)(1)(i) of the guidelines or
its equivalent), it meets the performance standard in OPPTS
810.2100(i)(3)(i) of the guidelines or its equivalent.
(2) Multiple use towelettes. A multiple use towelette may bear a
claim as a ``multiple use towelette for the disinfection of hard
surfaces'' if, when tested by the methods and standards approved by EPA
(OPPTS 810.2100(i)(1)(ii) of the guidelines or its equivalent), it
meets the performance standard in OPPTS 810.2100(i)(3)(ii) of the
guidelines or its equivalent.
(f) Unacceptable claims. (1) A product that functions by fogging
may not bear claims of disinfection for duct systems, air, or room
surfaces.
(2) Products with circulate-in-place (CIP) applications may not
bear claims of disinfection because CIP application has not been shown
to be effective in disinfecting duct systems, air or room surfaces. CIP
products may, however, bear claims of sanitization if they meet the
performance standard of Sec. 156.451.
Sec. 156.447 Fungicidal claim on hard surfaces.
(a) Performance standard. (1) The product meets the performance
standard of OPPTS 810.2100(d) of the guidelines or its equivalent as a
broad spectrum disinfectant; and
(2) When tested in accordance with the test methods and standards
in OPPTS 810.2100(f) of the guidelines or its equivalent, the product
kills all fungal spores.
(b) Acceptable claim. A product that meets the performance standard
in
[[Page 50728]]
paragraph (a) of this section may bear a claim of effectiveness as a
``fungicide'' or against ``pathogenic fungi'' on appropriate surfaces
or sites.
Sec. 156.448 Virucidal claim on hard surfaces.
(a) Performance standard. (1) The product meets the performance
standard of OPPTS 810.2100(d) of the guidelines or its equivalent as a
broad spectrum disinfectant; and
(2) When tested in accordance with the test methods and standards
in OPPTS 810.2100(g) of the guidelines or its equivalent, the product:
(i) Inactivates virus at all dilutions when cytotoxicity is not
observed in the assay system, or at all dilutions above the cytotoxic
level when cytotoxicity is observed; and
(ii) Achieves at least a 99.9% (3-log) reduction in viral titer in
all samples when cytotoxicity is present.
(b) Acceptable claim--(1) Combination disinfectant/virucidal
products. A disinfectant product that also meets the performance
standard in paragraph (a) of this section may also bear a claim of
effectiveness as a ``virucide'' or as ``virucidal.'' The product
labeling must identify the specific viruses against which the product
is effective.
(2) Virucide only products. A product that meets the performance
standard in paragraph (a) of this section, but is not a disinfectant,
may bear only a limited claim of effectiveness against viruses
specifically tested against, and must bear a disclaimer that the
product is not a disinfectant.
(3) HIV/HBV claims. A claim for virucidal activity against HIV-1,
HIV-2, or hepatitis B (HBV) viruses may be made only for use sites that
involve human health care or other sites where there is a likelihood of
soiling of inanimate surfaces or objects with blood or body fluids.
Sec. 156.449 Tuberculocidal claim on hard surfaces.
(a) Performance standard. (1) The product meets the performance
standard of OPPTS 810.2100(d) of the guidelines or its equivalent as a
broad spectrum disinfectant; and
(2) When tested in accordance with one of the test methods and
standards in OPPTS 810.2100(h) of the guidelines or its equivalent, the
product meets the performance standard for that test method in OPPTS
810.2100(h)(3) of the guidelines or its equivalent.
(b) Acceptable claim. A product that meets the performance standard
in paragraph (a) of this section may bear a claim of effectiveness as a
``tuberculocide.''
Sec. 156.451 Sanitizing claim on hard surfaces.
(a) Products for use on non-food contact surfaces--(1) Performance
standard. When tested in accordance with the test methods and standards
in OPPTS 810.2100(l) of the guidelines or its equivalent, the product
achieves at least a 99.9% (3-log) reduction in the number of test
microorganisms over the parallel control count within 5 minutes.
(2) Acceptable claims. A product that meets the performance
standard in paragraph (a)(1) of this section may bear a claim of
effectiveness as a ``sanitizer for hard, non-food contact surfaces.''
(b) Products for use on previously-cleaned food contact surfaces--
(1) Performance standard for products containing halides. When tested
in accordance with the test methods and test standards in OPPTS
810.2100(m)(1) of the guidelines or its equivalent, the product meets
the performance standard of OPPTS 810.2100(m)(1) of the guidelines or
its equivalent.
(2) Performance standard for products not containing halides. When
tested in accordance with the test methods and test standards in OPPTS
810.2100(m)(2) of the guidelines or its equivalent, the product
achieves a 99.999% (5-log) reduction in the number of each test
microorganism within 30 seconds.
(3) Acceptable claims. A product that meets the appropriate
performance standard in paragraph (b) of this section may bear a claim
of effectiveness as a ``sanitizer for hard food contact surfaces.''
(4) Unacceptable claims. A product labeled for food surface
sanitizing may not bear a claim for ``one-step'' or combination
cleaning and sanitizing. Sanitizing claims for food surfaces may be
made only in conjunction with use directions that require a cleaning
step prior to sanitization.
Sec. 156.452 Residual self-sanitizing claim on hard surfaces.
(a) Performance standard. When tested in a controlled or simulated
in-use study under OPPTS 810.2100(o) of the guidelines or its
equivalent, whose protocol has been approved by the Agency, the product
meets the performance standard of OPPTS 810.2100(o)(3) of the
guidelines or its equivalent.
(b) Acceptable claim. A product that meets the performance standard
in paragraph (a) of this section may bear a claim of residual ``self-
sanitizing'' activity keyed to the presence of moisture on surfaces
that are likely to become and remain wet under normal conditions of
use. A ``residual'' claim must also include the duration of
effectiveness.
Sec. 156.453 Laundry additives.
(a) Pre-soak disinfection--(1) Performance standard. When tested in
accordance with the test methods and standards in OPPTS 810.2300(b)(1)
of the guidelines or its equivalent, the product meets the performance
standard of OPPTS 810.2100(c), (d), and (e) of the guidelines or its
equivalent. Although the performance standard is the same for all
disinfectant claims, the test standards and test microorganisms define
the level of disinfectant claim that may be made on product labeling.
(2) Acceptable claim. A product that meets the performance
requirement in paragraph (a)(1) of this section may bear a claim as a
``disinfectant'' for pre-soaking fabrics prior to laundering.
(b) Pre-soak sanitization--(1) Performance standard. When tested in
accordance with the test methods and standards in OPPTS 810.2300(b)(2)
of the guidelines or its equivalent, the product achieves at least a
99.9% (3-log) reduction in the number of each test microorganism over
the control count within 5 minutes.
(2) Acceptable claim. A product that meets the performance
requirement in paragraph (b)(1) of this section may bear a claim as a
``sanitizer'' for pre-soaking fabrics prior to laundering.
(c) Non-residual disinfecting in-use additives--(1) Performance
standard. When tested in accordance with the simulated-use procedure in
OPPTS 810.2300(b)(3) of the guidelines or its equivalent or an actual
in-use study whose protocol has been approved by the Agency, the
product meets the performance standard of OPPTS 810.2300(b)(3) of the
guidelines or its equivalent.
(2) Acceptable claim. A product that meets the performance
requirement in paragraph (c)(1) of this section may bear a claim as a
``disinfectant'' for use in laundry operations.
(d) Non-residual sanitizing in-use additives--(1) Performance
standard. When tested in accordance with the test methods and standards
in OPPTS 810.2300(b)(4) of the guidelines or its equivalent, the
product meets the performance standard of OPPTS 810.2300(b)(4).
(2) Acceptable claim. A product that meets the performance
requirement in paragraph (d)(1) of this section may bear a claim as a
``sanitizer'' for use in laundry operations.
(e) Residual self-sanitizing in-use additives--(1) Performance
standard. When tested in accordance with the simulated-use procedure in
OPPTS
[[Page 50729]]
810.2300(b)(5) of the guidelines or its equivalent, the product
achieves at least 99.9% (3-log) reduction of each test microorganism
over the zero-time and untreated control.
(2) Acceptable claim. A product that meets the performance standard
in paragraph (e)(1) of this section may bear a claim of ``residual
self-sanitizer'' for use in laundry operations when laundered articles
are likely to become and remain wet (e.g., diapers), or be exposed to
high humidity under normal conditions of use and storage.
Sec. 156.454 Fabrics and textiles.
(a) Carpets--(1) Performance standard. When tested in accordance
with the test methods and standards in OPPTS 810.2300(c) of the
guidelines or its equivalent, the product achieves at least a 99.9% (3-
log) reduction in the number of test microorganisms over the scrubbed
controls.
(2) Acceptable claims. A product that meets the performance
standard in paragraph (a)(1) of this section may bear a claim as a
``sanitizer'' for carpets.
(b) Mattresses and upholstered furniture--(1) Performance standard.
Only gas or fumigant treatments are acceptable for control of
pathogenic microorganisms in or on these articles. When tested in
accordance with a simulated use study under OPPTS 810.2300(d) of the
guidelines or its equivalent, whose protocol has been approved by the
Agency, the product meets one of the following standards:
(i) The performance standard in Sec. 156.445(a) for a sterilizer.
(ii) The performance standard in Sec. 156.446(a) for a
disinfectant.
(iii) The performance standard in Sec. 156.451(a) for a sanitizer.
(2) Acceptable claims. A product that meets the appropriate
performance standard in paragraph (b)(1) of this section may bear the
associated claim as a ``sterilant,'' ``disinfectant,'' or ``sanitizer''
for mattresses, upholstered furniture, pillows, and similar bulky
articles. Separate directions for use must be provided for each claimed
level of activity.
(c) Impregnated self-sanitizing fabrics and textiles--(1)
Performance standard. When tested in a controlled or simulated in-use
study under OPPTS 810.2300(e)(3) of the guidelines or its equivalent,,
whose protocol has been approved by the Agency, the product meets the
performance standard in Sec. 156.452(a).
(2) Acceptable claims. A product that meets the performance
standard in paragraph (c) of this section may bear a claim for
``residual self-sanitizing'' of treated fabrics and textiles in the
presence of moisture. The duration of effectiveness must be specified.
Sec. 156.455 Air sanitizers.
(a) Performance standard--(1) Glycol-containing products. When
tested in accordance with a protocol that has been approved by the
Agency, the product achieves an actual glycol vapor concentration of at
least 50% saturation in a test enclosure.
(2) Other products. When tested in accordance with a protocol that
has been approved by the Agency, the product achieves, for each
required test microorganism, at least a 99.9% (3-log) reduction in the
number of viable microorganisms in the air of the test enclosure, after
correction for settling rates.
(b) Acceptable claims. A product that meets either of the
performance standards in paragraph (a) of this section may bear a claim
as an ``air sanitizer.'' This claim must be accompanied by a statement
clearly indicating the mitigating level of the activity, such as
``Temporarily reduces the number of airborne bacteria.''
(c) Unacceptable claims. An air sanitizer may not bear a claim as a
sterilant, disinfectant, or germicide.
Sec. 156.456 Toilets and urinals.
(a) Toilet bowls--(1) Performance standard. When tested in
accordance with the test methods and standards in OPPTS 810.2100(c),
(d), or (e), or OPPTS 810.2600(b)(2) of the guidelines or its
equivalent, the product meets one of the following standards:
(i) The performance standard in Sec. 156.446(a) for a disinfectant.
(ii) The performance standard in Sec. 156.451(a) for a sanitizer.
(2) Acceptable claims. A product that meets the appropriate
performance standard in paragraph (a)(1) of this section may bear the
associated claim as a ``disinfectant'' or ``sanitizer'' for toilet bowl
surfaces. Separate use directions must be provided for ``disinfectant''
and ``sanitizer'' levels of activity.
(3) Unacceptable claims. A product may not bear claims for
disinfecting the hidden trap of the toilet, nor may a solution for tank
use bear claims for disinfecting or sanitizing the bowl surface during
flushing.
(b) Toilet bowl water--(1) Performance standard. When tested in
accordance with a simulated-use study described in OPPTS 810.2600(c) of
the guidelines or its equivalent, the product achieves at least a 99.9%
(3-log) reduction in the number of each test microorganism over the
zero-time and parallel untreated inoculated controls.
(2) Acceptable claims. A product that meets the performance
standard in paragraph (b) of this section may bear a claim as a
``sanitizer'' for toilet water.
(3) Unacceptable claims. No claim other than sanitization may be
made for toilet in-tank products.
(c) In-tank products--(1) Performance standard. When tested in
accordance with a preliminary simulated in-use test and a laboratory
efficacy test whose protocol has been approved by the Agency, the
product achieves at least a 99.9% (3-log) reduction in the number of
each test microorganism over the zero-time and parallel untreated
inoculated controls.
(2) Acceptable claims. A product that meets the performance
standard in paragraph (c)(1) of this section may bear a claim as an
``in-tank sanitizer'' against pathogenic microorganisms in toilet
water.
156.457 Human drinking water.
(a) Water treatment units and chemical substances--(1) Performance
standard. When tested in accordance with the test methods and standards
of the EPA Guide Standard and Protocol, the product achieves the
reductions in the numbers of required test microorganisms (bacteria,
viruses, and protozoan cysts) given in the table to this paragraph.
Performance Standard Reductions for Microbiological Water Purifiers
------------------------------------------------------------------------
Minimum required reduction
Organisms ---------------------------------------
Percent Log
------------------------------------------------------------------------
Bacteria 99.9999 6
Viruses 99.99 4
Protozoan cysts 99.9 3
or
Particles or spheres, 4-6
microns diameter (for
filtration occlusion units)
------------------------------------------------------------------------
(2) Acceptable claim. A product that meets the performance standard
in paragraph (a)(1) of this section may be labeled as a
``microbiological water purifier'' or ``microbiological water
purification system.''
(3) Unacceptable claim. A product that does not meet the
performance standard in paragraph (a)(1) of this section for all test
organisms required by the Guide Standard and Protocol may not bear on
the labeling any terms or statements of express or implied ``water
purification'' or variants thereof. Similarly terms such as
``sanitize'' or variants thereof, ``pure'' or ``purify'' and
[[Page 50730]]
``hygienic'' or variants thereof are not acceptable.
(b) [Reserved]
Sec. 156.458 Swimming pool and spa water.
(a) Performance standard. (1) When tested in accordance with the
test methods and standards in OPPTS 810.2700(d) of the guidelines or
its equivalent, the product achieves efficacy equivalent to that
achieved in a test using a sodium hypochlorite control; and
(2) When tested under in-use conditions (field test) under a
protocol approved by the Agency, the product demonstrates that more
than 85% of samples collected meet all of the following bacterial
indices:
(i) The standard plate count at 35 deg.C does not exceed 200
colonies per 1.0 milliliter (ml).
(ii) The most probable number of coliform bacteria is less than 2.2
organisms per 100.0 ml, or, if a membrane filter test is used, less
than 1.0 coliform organism per 50 ml.
(iii) The most probable number of enterococcal organisms is less
than 2.2 organisms per 100.0 ml, or if the membrane filter test is
used, less than 1.0 enterococcal organism per 50 ml.
(b) Acceptable claims. A product that meets the performance
standard in paragraph (a) of this section may bear a claim as a
``disinfectant'' for swimming pool water or water in hot tubs,
jacuzzis, spas, or whirlpools.
[FR Doc. 99-24181 Filed 9-14-99; 12:13 pm]
BILLING CODE 6560-50-F
