[Federal Register Volume 64, Number 207 (Wednesday, October 27, 1999)]
[Notices]
[Pages 57881-57884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28047]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00569B; FRL-6388-2]
Pesticides; Policy Issues Related to the Food Quality Protection
Act
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.
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SUMMARY: EPA is announcing the availability of the revised version of
the pesticide science policy document entitled ``Threshold of
Regulation (TOR) Policy--Deciding Whether a Pesticide With a Food Use
Pattern Requires a Tolerance.'' This notice is the twelfth in a series
concerning science policy documents related to Food Quality Protection
Act and developed through the Tolerance Reassessment Advisory
Committee.
FOR FURTHER INFORMATION CONTACT: Vivian Prunier, Environmental
Protection Agency (7506C), 401 M St., SW., Washington, DC 20460;
telephone number: (703) 308-9341; fax: (703) 305-5884; e-mail address:
prunier.vivian@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 science policy documents, and certain other related
documents that might be available electronically, 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 to 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 revised
science policy paper, as well as supporting information, by using a
faxphone to call (202) 401-0527. Select item 6042 for the paper
entitled ``Threshold of Regulation (TOR) Policy--Deciding Whether a
Pesticide With a Food Use Pattern Requires a Tolerance.'' 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-00569B. 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, 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.
II. Background for the Tolerance Reassessment Advisory Committee
(TRAC)
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
[[Page 57882]]
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 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 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 it believes
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) (FRL-6041-5), EPA is announcing through the Federal Register the
availability of a series of draft documents concerning nine science
policy issues identified by the TRAC related to the implementation of
FQPA. After receiving and reviewing comments from the public and
others, EPA is also issuing revised science policy documents which
reflect changes made in response to comments. In addition to comments
received in response to these Federal Register notices, EPA will
consider comments received during the TRAC meetings. Each of these
issues is evolving and in a different stage of refinement. Accordingly,
as the issues are further refined by EPA in consultation with USDA and
others, they may also be presented to the SAP.
III. Summary of Revised Science Policy Guidance Document
This Federal Register notice announces the availability of a
revised version of the EPA pesticide science policy guidance document
that has been retitled ``Threshold of Regulation (TOR) Policy--Deciding
Whether a Pesticide With a Food Use Pattern Requires a Tolerance.'' The
guidance document describes the approach that EPA will use for
determining when a food use pattern does not produce residues in or on
food that require establishment of a tolerance or tolerance exemption.
Specifically, the guidance document describes:
A. EPA's authority for determining whether a tolerance or tolerance
exemption is, or is not, required.
B. The criteria that EPA will use for determining whether a
tolerance is required for a pesticide use in, on, or near food that
produces no detected residues in the food.
C. The data, including toxicology and residue chemistry studies,
that EPA will rely upon when deciding whether a tolerance is required.
D. Procedures that EPA will follow for evaluating new or existing
pesticide uses that meet the criteria of the TOR policy.
E. Procedures that EPA will follow to establish a regulation in
title 40 of the Code of Federal Regulations (CFR) for each use that
meets the criteria of the TOR policy.
The Agency plans to use this guidance during tolerance reassessment
to determine whether a tolerance is needed for existing uses. The
Agency expects to use this guidance to evaluate proposed pesticide uses
that could replace pesticide uses that are being discontinued. EPA
believes that this policy will promote a reasonable transition for
agriculture.
IV. Issues Raised in Comments
EPA published a draft version of the document described in Unit
III. in the Federal Register on December 4, 1998 (63 FR 67063) (FRL-
6048-2) and comments were filed under docket control number OPP-00569.
The original public comment period ended on February 4, 1999, but was
extended to February 18, 1999, in a Federal Register document published
on February 5, 1999 (64 FR 5795) (FRL-6061-5). The Agency received
comments from 22 different organizations. All comments were considered
by the Agency in revising the document. The comments and the Agency's
responses to these comments are briefly summarized in this Unit.
Many of the comments were similar in content, and pertained to
general issues concerning the proposed policy or specific sections
within the draft document. To facilitate review and consideration of
the comments for purposes of revising the document, the Agency grouped
the comments in accordance to nature of the comment, or issue or
section of the document with which they addressed. Hence, comments were
grouped as follows:
A. The purpose and effects of the policy.
B. Residue chemistry data requirements.
C. Toxicity data requirements.
D. Risk criteria for TOR decisions.
E. Registration criteria for pesticide uses that meet the criteria
of the TOR policy.
F. Procedural issues, including publication of decisions made under
the policy, enforcement, and assessment of fees.
The full text of the Agency's comments and response to the
comments document is available as described in Unit I.B.1.
The comments raised several significant issues including:
1. What is EPA's authority for deciding that a tolerance is not
required for a pesticide use in, on, or near food?
EPA has interpreted section 402 of the Federal Food, Drug and
Cosmetic Act (FFDCA) as meaning that any use of a
[[Page 57883]]
pesticide in, on, or near growing crops, livestock, or food will result
in residues in the food that are subject to section 408 of the Act
unless the EPA decides otherwise. The TOR policy would establish
criteria to decide whether additional food use patterns, in addition to
those identified in 40 CFR 180.6, do not produce residues in food for
which a tolerance or tolerance exemption is required. EPA finds that
sections 408(e) and 701(a) of the FFDCA give EPA authority to issue
regulations necessary to interpret the Act.
2. How will EPA implement, publish, and compile TOR decisions? How
will FDA enforce TOR decisions?
Commenters asked EPA to publish notices of TOR policy decisions
that specify the conditions of use and analytical method used to
support each TOR decision and to maintain a list of TOR decisions in
the CFR.
EPA has decided to issue each TOR decision as a regulation. The TOR
regulation will identify the pesticide, conditions of use of the
pesticide, and the analytic method that the Agency relied on in
determining that the use of the pesticide would not produce detectable
residues. This information will guide growers or other pesticide users
who wish to employ a pesticide for a TOR use and should enable them to
avoid misusing the pesticide.
This policy does not alter FDA's enforcement in any way. FDA
monitors food for pesticide residues. FDA will continue to monitor food
in interstate commerce for pesticide residues. To detect and quantify
pesticide residues in a food, FDA may use either the analytical method
that EPA relied upon in making the TOR decision or another method.
Because the TOR policy is based on the premise that no residues will be
found in a food following the use of a pesticide, FDA will continue to
regard any residue finding for which there is no tolerance or tolerance
exemption as a violation of the FFDCA and would deem the food as
adulterated under section 402(a)(2)(B) of the FFDCA.
3. What would happen to a TOR use if a more sensitive analytical
method is developed?
Food processors were concerned that FDA would eventually develop
more sensitive enforcement methods and would be able to detect residues
from TOR uses.
EPA agrees that advances in the science of analytical chemistry
may eventually produce methods that are capable of detecting pesticide
residues from TOR uses. If FDA adopts a new enforcement method that is
more sensitive than the method described in the TOR regulation and
subsequently detects residues in a food, it could deem the food to be
adulterated under section 402 of the FFDCA. However, FDA generally
provides the public ample notice when it is considering adopting a new
analytical method for enforcement purposes. A person who is relying on
a TOR approval to support a pesticide use would have opportunity to
evaluate the new analytical method before FDA adopts it.
4. Several commenters asserted that EPA should expand the TOR
Policy criteria to include detected residues that pose risks that are
so inconsequential that they are ``de minimis'' and should not be
regulated.
Under this principle, an agency may decide that some violations of
the law are so trivial that they are not worth regulating. The
commenters argued that, if EPA applies this principle, it would be able
to find that a residue does not need to be regulated under FFDCA
section 408 if a given level of a particular pesticide based on the
hazard characteristics of the pesticide poses a ``de minimis'' risk.
Detected residues of a pesticide could also be eligible for
consideration under a ``de minimis'' policy.
EPA's approach does not attempt to write an exception to the
statutory language as does the de minimis principle; rather, EPA has
relied upon the less controversial legal approach of fashioning a
reasonable interpretation of existing statutory language -- here, ``any
pesticide chemical residue in or on a food.'' EPA's policy describes
criteria that will be taken into account in determining when a
pesticide can be deemed to be ``in or on food'' when the pesticide is
NOT detectable on the food. EPA's approach of focusing on the risk
posed by potential residues is a reasonable interpretation of when zero
detected residues means the pesticide is not in or on food.
EPA chose not to rely on the de minimis doctrine as its primary
justification for several reasons. First, despite the fact that the de
minimis principle is well-established, there is always some legal risk
when an agency asks a court to disregard the plain language of the
statute. In the event that a court concludes that potential risk is not
an appropriate consideration in determining when undetected residues
qualify as residues ``in or on food,`` the de minimis principle
provides a secondary justification for EPA's approach. Second, reliance
on a de minimis theory as a primary justification is only necessary if
EPA's policy extends to pesticide residues that are detectable.
However, EPA is uncertain whether an expansion of TOR to detected
residues posing insignificant risks is necessary to meet the concerns
that motivated EPA to formulate the TOR policy. If, at some later date,
EPA decides to explore an expansion of TOR, EPA would at that time
evaluate the application of the de minimis doctrine as the primary
justification for the TOR policy. Finally, EPA does not need to rely on
the de minimis principle in order to apply the policy. As outlined in
the policy, EPA has already been making this type of determination as
to a considerable range of pesticide uses.
5. The criteria in the ``essentially zero'' exposure approach
proposed in the draft TOR policy blurred the distinction between a food
use pattern that is subject to FFDCA and a non-food use that is not
subject to FFDCA.
It appears that the proposed ``essentially zero`` exposure
approach for a TOR determination could be interpreted as applying both
to food uses e.g., uses that result in a reasonable expectation of no
finite residues in milk, meat, poultry or eggs and to uses that are
likely to be classified as ``non-food'' uses.
EPA modified the policy to make clear that it applies to the uses
of pesticide in, on, or near growing crops, livestock, or food and not
to uses that have been classified as ``non-food'' uses.
EPA found that the proposed ``essentially zero'' exposure approach
for a TOR determination could be interpreted as applying to certain
food uses e.g., uses that result in no finite residues in milk, meat,
poultry, or eggs. EPA already has procedures for handling ``essentially
zero'' residues in some foods in 40 CFR 180.6(a)(3) and 180.6(c)(3).
Because a mechanism already exists for managing certain pesticide uses
that result in ``essentially zero'' residues in food, EPA believes that
the ``essentially zero'' exposure approach proposed in the TOR policy
is redundant and potentially confusing. To eliminate this confusion,
EPA will not use the ``essentially zero'' exposure approach in its TOR
policy.
6. Should EPA make TOR decisions in the absence of data to
characterize a pesticide's hazard?
A government Agency advised EPA to continue to require toxicity
information for all food use patterns, including uses that meet the
criteria of the TOR policy.
When EPA originally proposed ``essentially zero'' exposure
criteria for TOR decisions, it reasoned that if exposure is
``essentially zero,'' risk would also be ``essentially zero.'' EPA has
reconsidered this position, however, because it cannot conclude with
certainty that very low exposures are
[[Page 57884]]
without risk if there is no relevant information about the biological
activity of the pesticide. Accordingly, EPA expects to evaluate the
array of toxicity data that are normally used in a dietary risk
assessment in order to identify health hazards and quantify a dose
response. The Agency will normally perform a quantitative risk
assessment before concluding that a specific use poses ``essentially
zero'' risk from dietary exposures. Therefore, proponents of a TOR use
should provide a full set of toxicity data, as specified in 40 CFR
158.340.
7. What criteria will be used to define ``essentially zero'' risk
for infants and children?
EPA should explain what ``acceptable risk'' means with respect to
risks to infants and children or other subpopulations when the Agency
states that food risks from a TOR use must be less than 0.1% of
acceptable risks.
EPA will separately evaluate the incremental dietary risk (i.e.,
risks from food) posed by a proposed TOR use to each population
subgroup, particularly infants and children. If EPA has already
determined the appropriate FQPA safety factor for a particular
pesticide, EPA will use this safety factor in its evaluation of the
proposed TOR use. If EPA has not established an FQPA safety factor, EPA
will, as a matter of policy, decide whether the FQPA safety factor is
appropriate, and if so, the Agency will use it when evaluating the
potential risk posed by the proposed TOR use to infants and children.
8. The risk criteria in the TOR policy represent ``risk management
policy,'' not ``science policy.'' Furthermore, the definition of
``essentially zero'' risk is so restrictive that few pesticide uses
will qualify.
Several commenters asked that EPA ease the risk criterion,
recommending either a specific value such as 1% of acceptable risk for
the pesticide or more subjective criterion such as ``an insignificant
proportion of allowable risk'' be used as the risk threshold in the TOR
policy.
EPA agrees that the selection of the risk criterion for the TOR
policy is a risk management rather than a science policy decision. EPA
intends that the exposures from TOR uses be so small that risk
resulting from such exposures would be of no concern. Because selection
of the risk criterion for TOR decisions is a risk management decision;
the risk level itself should connote the triviality of the risk.
EPA conducted its own analysis to ascertain whether the selected
risk criteria were so strict that no uses would qualify. The results
suggest that many pesticides will qualify for a TOR for use on a food
item that is a minor component of the diets of the general U.S.
population or children aged 1 to 6 years.
9. Some interpreted the policy to mean that if there are no
detected residues above 10 ppb, no tolerances are needed.
EPA finds that this interpretation is not accurate. Tolerances (or
exemptions from tolerance) continue to be required for any use of a
pesticide in, on, or near food unless EPA determines that the use meets
TOR criteria.
10. EPA should adopt alternative criteria for deciding not to
establish tolerances for potential residues resulting from the use of
pesticides to treat seeds.
Registrants of seed treatment asserted that exposures from seed
treatment uses would be even lower than exposures from other uses that
may be eligible for TOR decisions. Accordingly, EPA should adjust data
requirements and other criteria for making TOR decisions on seed
treatment uses.
The Agency will apply the criteria in the revised TOR Policy to
seed treatment uses. As discussed above, a proponent of a TOR use would
normally be expected to submit the full toxicity data set for a food
use. EPA will, however, consider waiving toxicity data requirements on
a case-by-case basis.
11. EPA should not require tolerance fees for TOR requests because
fees can be charged only for actions done under FFDCA 408.
TOR eligibility determinations involve application of FFDCA
section 408. The decision whether FFDCA section 408 applies to a
particular case is itself a section 408 action. Accordingly, EPA could
require payment of a ``tolerance fee'' to cover the costs of evaluating
a TOR eligibility request.
V. Policies Not Rules
The policy document 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 surrounding a
specific risk assessment demonstrate that a policy should be abandoned.
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests.
Dated: October 17, 1999.
Susan H. Wayland,
Deputy Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 99-28047 Filed 10-26-99; 8:45 am]
BILLING CODE 6560-50-F
