[Federal Register Volume 64, Number 217 (Wednesday, November 10, 1999)]
[Notices]
[Pages 61343-61346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29296]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00625; FRL-6388-8]
Pesticides; Policy Issues Related to the Food Quality Protection
Act
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.
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SUMMARY: To assure that EPA's policies related to implementing the Food
Quality Protection Act are transparent and open to public
participation, EPA is soliciting comments on the pesticide draft
science policy paper entitled ``Guidance for Performing Aggregate
Exposure and Risk Assessments.'' This notice is the thirteenth in a
series concerning science policy papers related to Food Quality
Protection Act and the Tolerance Reassessment Advisory Committee.
DATES: Comments for the draft science policy paper, identified by
docket control number OPP-00625, must be received on or before January
10, 2000.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION.'' To ensure
proper receipt by EPA, it is imperative that you identify docket
control number OPP-00625 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: Carol Christensen, Environmental
Protection Agency (7505C), 401 M St., SW., Washington, DC 20460;
telephone number: (703) 305-6230; fax: (703) 305-7147; e-mail:
christensen.carol@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture
or formulate pesticides. Potentially affected categories and entities
may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS potentially
affected entities
------------------------------------------------------------------------
Pesticide producers 32532 Pesticide
manufacturers
Pesticide
formulators
------------------------------------------------------------------------
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 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 affects certain entities. If you have any questions regarding
the applicability of this action to a particular entity, consult the
person listed under ``FOR FURTHER INFORMATION CONTACT.''
B. How Can I Get Additional Information, Including Copies of this
Document or Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, the draft science policy paper, and certain other related
documents that might be available from the Office of Pesticide
Programs' Home Page at http://www.epa.gov/pesticides/. On the Office of
Pesticide Programs' Home Page select ``FQPA'' and then look up the
entry for this document under ``Science Policies.'' You can also go
directly to the listings at the EPA Home Page at http://www.epa.gov/.
On the Home Page select ``Laws and Regulations'' and then look up the
entry for this document under ``Federal Register-- Environmental
Documents.'' You can go directly to the Federal Register listings
http://www.epa.gov/fedrgstr/.
2. Fax on demand. You may request a faxed copy of the draft science
policy paper, as well as supporting information, by using a faxphone to
call (202) 401-0527. Select item 6043 for the paper entitled ``Guidance
for Performing Aggregate Exposure and Risk Assessments.'' You may also
follow the automated menu.
3. In person. The Agency has established an official record for
this action under docket control number OPP-00625. In addition, the
documents referenced in the framework notice, which published in the
Federal Register on October 29, 1998 (63 FR 58038) (FRL-6041-5) have
also been inserted in the docket under docket control number OPP-00557.
The official record consists of the documents specifically referenced
in this action, 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 Hwy.,
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 through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number OPP-00625 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 (OPP), Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460.
2. In person or by courier. Deliver your comments to: Public
Information
[[Page 61344]]
and Records Integrity Branch (PIRIB), Information Resources and
Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB
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 6.1/
8.0 or ASCII file format. All comments in electronic form must be
identified by docket control number OPP-00625. Electronic comments may
also be filed online at many Federal Depository Libraries.
D. How Should I Handle CBI That I Want to Submit to the Agency?
Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI 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. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person identified under ``FOR FURTHER INFORMATION
CONTACT.''
E. What Should I Consider As I Prepare My Comments for EPA?
EPA invites you to provide your views on the various draft science
policy papers, new 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
notice.
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. To ensure proper receipt by EPA, it is imperative that
you identify docket control number OPP-00625 in the subject line on the
first page of your response. You may also provide the name, date, and
Federal Register citation.
II. Background for the Tolerance Reassessment Advisory Committee
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA)
was signed into law. Effective upon signature, the FQPA significantly
amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
and the Federal Food, Drug, and Cosmetic Act (FFDCA). Among other
changes, FQPA established a stringent health-based standard (``a
reasonable certainty of no harm'') for pesticide residues in foods to
assure protection from unacceptable pesticide exposure; provided
heightened health protections for infants and children from pesticide
risks; required expedited review of new, safer pesticides; created
incentives for the development and maintenance of effective crop
protection tools for farmers; required reassessment of existing
tolerances over a 10-year period; and required periodic re-evaluation
of pesticide registrations and tolerances to ensure that scientific
data supporting pesticide registrations will remain up-to-date in the
future.
Subsequently, the Agency established the Food Safety Advisory
Committee (FSAC) as a subcommittee of the National Advisory Council for
Environmental Policy and Technology (NACEPT) to assist in soliciting
input from stakeholders and to provide input to EPA on some of the
broad policy choices facing the Agency and on strategic direction for
the Office of Pesticide Programs. The Agency has used the interim
approaches developed through discussions with FSAC to make regulatory
decisions that met FQPA's standard, but that could be revisited if
additional information became available or as the science evolved. As
EPA's approach to implementing the scientific provisions of FQPA has
evolved, the Agency has sought independent review and public
participation, often through presentation of many of the science policy
issues to the FIFRA Scientific Advisory Panel (SAP), a group of
independent, outside experts who provide peer review and scientific
advice to OPP.
In addition, as directed by Vice President Albert Gore, EPA has
been working with the U.S. Department of Agriculture (USDA) and another
subcommittee of NACEPT, the Tolerance Reassessment Advisory Committee
(TRAC), chaired by the EPA Deputy Administrator and the USDA Deputy
Secretary, to address FQPA issues and implementation. TRAC comprises
more than 50 representatives of affected user, producer, consumer,
public health, environmental, states and other interested groups. The
TRAC has met six times as a full committee from May 27, 1998 through
April 29, 1999.
The Agency has been working with the TRAC to ensure that its
science policies, risk assessments of individual pesticides, and
process for decision making are transparent and open to public
participation. An important product of these consultations with TRAC is
the development of a framework for addressing key science policy
issues. The Agency decided that the FQPA implementation process and
related policies would benefit from initiating notice and comment on
the major science policy issues.
The TRAC identified nine science policy issue areas they believe
were key to implementation of FQPA and tolerance reassessment. The
framework calls for EPA to provide one or more documents for comment on
each of the nine issues by announcing their availability in the Federal
Register. In accordance with the framework described in a separate
notice published in the Federal Register of October 29, 1998 (63 FR
58038), EPA has been issuing a series of draft papers concerning nine
science policy issues identified by the TRAC related to the
implementation of FQPA. This notice announces the availability of the
draft science policy paper as identified in the ``SUMMARY.''
III. Summary of ``Guidance for Performing Aggregate Exposure and
Risk Assessments''
Pesticides are regulated under both FIFRA and FFDCA. In 1996,
Congress passed FQPA which amended both FIFRA and FFDCA. Through these
laws,
[[Page 61345]]
EPA evaluates risks posed by the use of each pesticide to make a
determination of safety. FQPA amended FFDCA to require the Agency to
consider aggregate exposure. Section 408(b)(2)(ii) requires EPA to find
for each tolerance ``a reasonable certainty that no harm will result
from aggregate exposure to the pesticide chemical residue, including
all anticipated dietary exposures and all other exposures for which
there is reliable information.'' Section 408(b)(2)(C)(ii)(I) requires
the Agency to find ``a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residues . . . .'' Finally, Section 408(b)(2)(D)(vi) directs EPA, when
deciding on tolerances, to consider ``aggregate exposure levels...to
the pesticide chemical residue . . . including dietary exposure and
exposure from other non-occupational sources.''
Implementation of FQPA has led to refinement of many decision
tools, including methods for assessment of aggregate exposure and risk.
The methods described in this paper increase the completeness and
realism of EPA's estimates of potential exposures to pesticides in the
environment. The Agency believes that these new assessment methods will
substantially improve protection of public health.
This draft science policy paper builds on the Interim Approach
Paper for the March 1997 Scientific Advisory Panel (USEPA, 1997c.) It
is one in a series of science policy papers developed to address new
requirements imposed by FQPA. It also relies heavily on the following
documents:
1. Exposure Factors Handbook.
2. Residential SOPs.
3. Interim Guidance for Conducting Aggregate Exposure and Risk
Assessments.
4. Guidance for Submission of Probabilistic Human Health Exposure
Assessments to the Office of Pesticide Programs.
An earlier draft of this science policy paper was reviewed by the
FIFRA SAP in February 1999. The Panel's comments and recommendations
were considered in this revision.
This draft science policy paper describes the general principles
and specific procedure for assessing aggregate non-occupational human
exposure and risk from a single chemical by all relevant pathways. The
routes and pathways considered at this time are oral (from food,
drinking water, and residential scenarios), inhalation (residential
pathway), and dermal (residential pathway). EPA recognizes the gaps in
understanding the interdependencies and linkages between and among
exposure pathways when assessing exposure to an individual, and that
further data collection is warranted in this area.
Currently, EPA combines single point estimates from the relevant
pathways to assess aggregate exposure. Under EPA's current interim
guidelines, for example, point estimates for drinking water and
residential exposure pathways are typically added to a point (such as
the 99.9th percentile) selected from the distribution of dietary
exposures. This draft science policy paper proposes a different
approach. Under these new guidelines an analyst first assesses exposure
by all pathways for one individual at a time; then the analyst combines
individual assessments into an overall assessment of exposures of a
sample population of interest. This method keeps each individual's
characteristics consistent; all exposures agree in time and place; and
all individual demographic characteristics are consistent and
reasonable. Using this approach an assessor can create a distribution
of total exposures to many individuals in a population of interest,
while retaining inter- and intra-individual variability. And, analysis
of distributional data can improve understanding, and even allow
quantification of the uncertainty and variability in the data sets. EPA
believes that these proposed changes to the performance of aggregate
exposure and risk assessment will lead to better and more realisitic
assessments of actual exposure and risk.
IV. Questions/Issues for Comment
While comments are invited on any aspect of the draft science
policy paper, OPP is particularly interested in comments on the
following questions and issues:
1. The draft science policy paper describes methodologies for
assessing pesticide risks from single exposure pathways (food,
residential and drinking water). Are these methodologies complete and
satisfactorily described, or are changes/additions recommended?
2. The draft science policy paper describes a process for
combining pesticide exposures and risk from multiple routes for a given
pathway of exposure. Is the process, as described, logical,
scientifically defensible, and complete?
3. A basic concept underlying the draft aggregate exposure and
risk assessment methodology is that of the individual being exposed
through calendar time with all model parameters referring back to that
specific individual. Is use of this fundamental principle as the basis
for the aggregate exposure and risk methodology appropriate and, if
not, how should it be modified?
4. The draft science policy paper acknowledges the need to
understand how exposures co-occur. OPP is developing standards to
identify co-dependencies and inter-relationships between events, and
recognizes that product marketing data may be available to aid in this
task. Are there any suggestions on how OPP can best evaluate and
incorporate into its assessments co-occurrences of exposure events?
5. During an aggregate exposure and risk assessment, some specific
exposure scenarios may be identified as having a minimal contribution
to the total aggregate risk. Is it appropriate to exclude specific
exposure scenarios that contribute minimally to the total aggregate
risk, and if so, at what risk level should an exposure scenario be
dropped from further consideration?
6. In certain cases and with certain pathways, it may not be
necessary, advisable, or even possible to develop probabilistic
exposure estimates and OPP may simply rely on deterministic (or point)
estimates of a pathway-specific exposure instead. When aggregating, it
will be necessary to combine the pathway-specific exposure estimates to
develop an estimate of aggregate exposure. Is OPP's general approach to
combining deterministic and probabilistic exposure estimates
appropriate? If not, how should it be modified?
7. The draft science policy paper describes three methods for
combining risks from the three routes (oral, dermal, and inhalation).
The Total MOE (MOET) and the Aggregate Risk Index (ARI) are currently
being used by OPP. Should OPP continue to use these approaches or
should OPP consider using the other described approach?
V. Policies Not Rules
The draft science policy paper discussed in this notice is intended
to provide guidance to EPA personnel and decision-makers, and to the
public. As a guidance document and not a rule, the policy in this
guidance is not binding on either EPA or any outside parties. Although
this guidance provides a starting point for EPA risk assessments, EPA
will depart from its policy where the facts or circumstances warrant.
In such cases, EPA will explain why a different course was taken.
Similarly, outside parties remain free to assert that a policy is not
appropriate for a specific pesticide or that the circumstances
[[Page 61346]]
surrounding a specific risk assessment demonstrate that a policy should
be abandoned.
EPA has stated in this notice that it will make available revised
guidance after consideration of public comment. Public comment is not
being solicited for the purpose of converting any policy document into
a binding rule. EPA will not be codifying this policy in the Code of
Federal Regulations. EPA is soliciting public comment so that it can
make fully informed decisions regarding the content of each guidance
document.
The ``revised'' guidance will not be unalterable. Once a
``revised'' guidance document is issued, EPA will continue to treat it
as guidance, not a rule. Accordingly, on a case-by-case basis EPA will
decide whether it is appropriate to depart from the guidance or to
modify the overall approach in the guidance. In the course of inviting
comment on each guidance document, EPA would welcome comments that
specifically address how a guidance document can be structured so that
it provides meaningful guidance without imposing binding requirements.
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, pesticides and pests.
Dated: October 29, 1999.
Susan H. Wayland,
Deputy Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 99-29296 Filed 11-9-99; 8:45 am]
BILLING CODE 6560-50-F
