[Federal Register Volume 64, Number 149 (Wednesday, August 4, 1999)]
[Notices]
[Pages 42372-42376]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20042]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00616; FRL-6093-2]
Pesticides; Policy Issues Related to the Food Quality Protection
Act
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.
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SUMMARY: To assure that EPA's policies related to implementing the Food
Quality Protection Act are transparent and open to public
participation, EPA is
[[Page 42373]]
soliciting comments on two draft science policy papers entitled
``Guidance for the Conduct of Bridging Studies for Use in Acute Dietary
Probabilistic Risk Assessments'' and ``Guidance for the Conduct of
Residue Decline Studies for Use in Acute Dietary Probabilistic Risk
Assessments.'' This notice is the eleventh in a series concerning
science policy documents related to FQPA and developed through the
Tolerance Reassessment Advisory Committee.
DATES: Comments for these draft science policy papers, identified by
docket control number OPP-00616, must be received on or before October
4, 1999.
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'' section. To
ensure proper receipt by EPA, it is imperative that you identify docket
control number OPP-00616 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: Kathleen Martin, Environmental
Protection Agency (7509C), 401 M St., SW., Washington, DC 20460;
telephone number: (703) 308-2857; fax: (703) 305-5147; e-mail:
martin.kathleen@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 in the ``FOR FURTHER INFORMATION CONTACT'' section.
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 and the two draft science policy papers from the Office of
Pesticide Programs Home Page at http://www.epa.gov/pesticides/. On the
Office of Pesticide Programs Home Page select ``TRAC'' and then look up
the entry for this document. 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 to receive a faxed copy of the
draft science policy papers, as well as supporting information, by
using a faxphone to call (202) 401-0527. Select item 6040 for the paper
entitled ``Guidance for the Conduct of Bridging Studies for Use in
Acute Dietary Probabilistic Risk Assessments'' and select item 6041 for
the paper entitled ``Guidance for the Conduct of Residue Decline
Studies for Use in Acute Dietary Probabilistic 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-00616. 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-00616 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 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 5.1/
6.1 or ASCII file format. All comments in electronic form must be
identified by docket control number OPP-00616. 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
[[Page 42374]]
CBI or the procedures for claiming CBI, please consult the person
identified in the ``FOR FURTHER INFORMATION CONTACT'' section.
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-00616 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
(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 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 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) (FRL-6041-5), EPA has been issuing a series of draft documents
concerning nine science policy issues identified by the TRAC related to
the implementation of FQPA. This notice announces the availability of
two draft science policy papers as identified in the ``SUMMARY''
section.
III. Summary of ``Guidance for the Conduct of Bridging Studies for
Use in Acute Dietary Probabilistic Risk Assessment Assessments''
and ``Guidance for the Conduct of Residue Decline Studies for Use
in Acute Dietary Probabilistic Risk Assessments''
These documents provide additional guidance to registrants, other
test sponsors, interested parties, and data reviewers on the extent and
quality of ``bridging data'' and ``residue decline data'' needed to
support the use of typical application rates in acute dietary
probabilistic exposure and risk assessments. Bridging data (generally
from side-by-side field trials) are used to establish a relationship
among residues from field trials conducted at the maximum application
scenario (e.g., maximum application rate, highest application
frequency, and shortest pre-harvest interval) and residues which would
result from more typical application rates. Residue decline data are
used to establish a relationship between pesticide residue levels at
the time of application or those following the minimum pre-harvest
interval to the pesticide residue levels which follow a range of
typical harvest times. This guidance provides information on how risk-
mitigation activities (e.g., lowered use rates) can be considered in
OPP risk assessments and used to adjust tolerance levels. Additional
specific desirable elements in an assessment and details (as well as
illustrative examples) are described. By following this guidance,
registrants and other sponsors may generate pesticide-specific data
that can be used by the Agency to produce highly refined, acute dietary
probabilistic exposure and risk assessments. While the data developed
in accordance with this guidance are preferred, EPA will also consider
other data or information as long as they would provide a
scientifically sound basis for estimating residues at typical
application rates for risk mitigation purposes.
IV. Questions/Issues for Comment
While comments are invited on any aspect of the draft science
policy papers,
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OPP is particularly interested in comments on the following questions
and issues. Due to the similarity in methods and techniques between the
companion papers describing bridging studies and residue decline
studies, the following questions relate to both papers.
1. Is the guidance provided in these draft documents clear and
complete? If not, why not and what additional guidance is needed?
2. Are the residue studies described in these documents adequate
for generating refined acute dietary probabilistic exposure and risk
assessments? If not, why not and how should they be modified?
3. OPP has proposed that between one and three field trials be
conducted, that at least three application rates and/or five pre-
harvest intervals (PHI) be tested, and that three composite samples be
collected at each application rate or PHI. Do these recommendations
appear to be reasonable and sufficient to establish a rate vs. residue
or PHI vs. residue relationship? Are data available which indicate that
these guidelines are adequate for the purposes intended? Explain.
4. OPP has stated that it believes that the field trials performed
for bridging study/residue decline purposes should be conducted (at an
exaggerated rate, if necessary) such that all residues are
``quantifiable'' (i.e., at or greater than the limit of quantitation
(LOQ)). We have stated that it would be considered inappropriate to
derive a quantitative relationship between application rate and residue
level on residues which were below the LOQ as this could introduce
substantial uncertainty into the estimated relationship. Please comment
on this proposed restriction. Please also comment on the recommendation
that studies be conducted at an exaggerated rate, if necessary, to
avoid the potential problem associated with non-quantifiable or non-
detectable residues.
5. OPP states that extrapolation of data between similar crops may
be allowed on a case-by-case basis considering similar cultural
practices and application patterns. Should these extrapolations be
limited to crops within a crop subgroup/group or should more extensive
extrapolations between groups be permitted? If so, on what basis should
more extensive extrapolations be permitted?
6. For the relationship produced by bridging or residue decline
data to be used in an exposure assessment, it is necessary to have
reliable usage data concerning application rates and/or pre-harvest
intervals. For example, if residues resulting from the full (maximum)
application rate, three-quarters of the maximum application rate, and
one-half the maximum application are determined, it is necessary to
also have information on the percentage (or fraction) of the time each
of these application rates are used. A similar situation exists for
pre-harvest intervals. Is this information available from either public
or proprietary sources? If so, from which sources can this data be
obtained and how readily available is it?
7. The proposed methodology uses what is believed to be the
statistically more appropriate ``lack of fit'' test to determine if the
hypothesized model (e.g., linear relationship between application rate
and residue level, first order decay in residue concentration with
time, etc.) is adequate to describe the data. Please comment on this
proposed approach and compare it with the more widely used coefficient
of determination (r2). Under what circumstances might the
use of r2 to judge a fit adequate be preferred to the ``lack
of fit'' test? There may be instances where the lack of fit test
reveals that the hypothesized linear association can be rejected, but
the coefficient of determination shows that a linear relationship
accounts for a significant portion of the variability. Should the two
be used in conjunction with one another and if so, how? What
statistical tests, if any, should be used to judge whether the
r2 is significant?
8. OPP will require that composite samples be collected as part of
reduced-use field trials in order to retain comparability with earlier
maximum rate/minimum PHI field trials conducted to support tolerance
decisions. Nevertheless, OPP still has concerns about the effect
compositing may have on unit-to-unit variation. When residue estimates
are generated from maximum application rate and minimum PHI's (worst-
case conditions), OPP believes that there is an adequate degree of
compensating overestimation such that individual unit variation is not
of concern. By incorporating the range of application rates and PHI's
in a probabilistic scenario, the conservatism built into our use of
field trial data is eroded and may require us to compensate for this
with statistically valid data on individual samples and/or unit-to-unit
variation. OPP is proposing that chemical-specific considerations be
considered to determine whether the use of composite data from reduced-
rate field trials is acceptable. Alternatively, a ``decomposition''
procedure may be judged appropriate. Please comment on whether these
concerns are justified and, if so, how they should be addressed by OPP.
9. In performing the regression analysis for bridging studies, OPP
has elected not to ``force'' the regression relationship through zero,
despite the fact that an application rate of 0 lbs ai/A would be
expected to result in a zero parts per million (ppm) concentration in
the plant or plant part. Please comment on this decision and any
required changes in interpretation of the statistical parameters which
a decision to force the regression through zero would entail.
10. OPP intends to combine the bridging study and residue decline
study guidance documents into one document. In doing so, would it be
useful to expand the section on multiple regression techniques? How
useful would this expansion be and are there any recommendations on how
this could best be done?
11. What other data or information similar to that described in
this guidance document would provide a sound, empirical basis for
determining residues at typical application rates for risk mitigation
purposes?
V. Policies Not Rules
The draft 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.
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
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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.
VI. Contents of Docket
Document that are referenced in this notice will be inserted in the
docket under docket control number``OPP-00616.'' In addition, the
documents referenced in the framework notice, which published in the
Federal Register on October 29, 1998 (63 FR 58038) have also been
inserted in the docket under docket control number OPP-00557.
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, pesticides and pests.
Dated: July 28, 1999.
Susan H. Wayland,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 99-20042 Filed 8-3-99; 8:45 am]
BILLING CODE 6560-50-F
