[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

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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

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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