[Federal Register Volume 64, Number 66 (Wednesday, April 7, 1999)]
[Notices]
[Pages 16967-16970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8259]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00591; FRL-6071-1]
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 (FQPA) are transparent and open to public
participation, EPA is soliciting comments on a draft policy paper
entitled ``Data for Refining Anticipated Residue Estimates Used in
Dietary Risk Assessments for Organophosphate Pesticides.'' This notice
is the sixth in a series concerning science policy documents related to
FQPA and developed through the Tolerance Reassessment Advisory
Committee (TRAC).
DATES: Submit written comments for this policy paper, identified by
docket control number OPP-00591, on or before June 7, 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 of
this document.
FOR FURTHER INFORMATION CONTACT: Margaret Rice, Environmental
Protection Agency (7508), 401 M St., SW., Washington, DC 20460;
telephone number: (703) 308-8039; fax: 703-308-8041; e-mail:
rice.margaret@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Notice Apply to Me?
You may be potentially affected by this notice if you manufacture
or formulate pesticides. Potentially affected categories and entities
may include, but are not limited to:
[[Page 16968]]
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Examples of
Categories NAICS potentially affected
entities
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Pesticide producers 32532 Pesticide
manufacturers
Pesticide formulators
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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. If
available, the North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this notice affects certain entities. If you have any
questions regarding the applicability of this announcement to you,
consult the technical person listed in the ``FOR FURTHER INFORMATION
CONTACT'' section of this document.
B. How Can I Get Additional Information or Copies of This Document or
Other Documents?
1. Electronically. You may obtain electronic copies of this
document and the science policy paper at http://www.epa.gov/
pesticides/. On the Office of Pesticide Program 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 the Federal Register -
- Environmental Documents entry for this document under ``Laws and
Regulations'' (http://www.epa.gov/fedrgstr/) to obtain this notice and
the science policy paper.
2. Fax on Demand. You may request to receive a faxed copy of this
document, as well as supporting information, by using a faxphone to
call (202) 401-0527 and selecting item 6033. You may also follow the
automated menu.
3. In person or by phone. If you have any questions or need
additional information about this action, you may contact the person
identified in the ``FOR FURTHER INFORMATION CONTACT'' section of this
document. In addition, the official record for the science policy paper
listed in the ``SUMMARY'' section of this document, including the
public version, has been established under docket control number OPP-
00591 (including comments and data submitted electronically as
described below). A public version of each record, including printed,
paper versions of any electronic comments, which does not include any
information claimed as Confidential Business Information (CBI), is
available for inspection in 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 Public Information and Records
Integrity Branch 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. Be sure to include docket control number OPP-00591 in
your correspondence.
1. By mail. Submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460.
2. In person or by courier. Deliver written comments to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis
Highway, Arlington, VA.
3. Electronically. Submit your comments and/or data electronically
by e-mail to: opp-docket@epa.gov. Do not submit any information
electronically that you consider to be CBI. Submit electronic comments
as an ASCII file, avoiding the use of special characters and any form
of encryption. Comments and data will also be accepted on standard
computer disks in WordPerfect 5.1/6.1 or ASCII file format. All
comments and data in electronic form must be identified by the docket
control number. Electronic comments on this notice may also be filed
online at many Federal Depository Libraries.
D. How Should I Handle CBI Information That I Want to Submit to the
Agency?
You may claim information that you submit 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. A copy of the comment that does
not contain CBI must be submitted for inclusion in the public record.
Information not marked confidential will be included in the public
docket by EPA without prior notice. If you have any questions about CBI
or the procedures for claiming CBI, please call the Public Information
and Records Integrity Branch telephone number is (703) 305-5805.
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. You can do this by providing the docket control number
assigned to the notice, along with the name, date and Federal Register
citation.
II. Background
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
[[Page 16969]]
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 five times as a full committee from May 27 through
September 16, 1998.
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. In addition to the nine science policy
issues, the Agency has decided to make available other policy documents
which are related to the implementation of FQPA, but which are not
purely science policy issues. This notice announces the availability of
one of those draft documents as identified in Unit I.C. of this
document.
III. Summary of Draft Paper
The Food Quality Protection Act (FQPA) of 1996 requires EPA to
reassess all existing tolerances, based on available information,
according to new, more stringent standards. Among these new standards
are specific determinations regarding the potential for increased
sensitivity of infants, children, and other subpopulations to the
pesticide, assessment of the potential for aggregate exposures from
various sources (such as the diet, drinking water, and pesticide uses
in and around the home) and cumulative assessments of pesticides with a
common mechanism of toxicity. EPA anticipates that refinements, beyond
those routinely applied to EPA's dietary exposure assessments, will be
key to developing more realistic estimates of the actual residues on
food as EPA proceeds through the aggregate and particularly the
cumulative assessment of pesticides which have a similar toxic effect
via a common mechanism of toxicity, for example, the organophosphates
(OPs). Having more realistic estimates of residues ultimately improves
the Agency's ability to make informed regulatory decisions that fully
protect public health and sensitive subpopulations, including infants
and children.
This document describes the types of data that can be used to
refine residue estimates, outlines the basic characteristics of useful
data, discusses how residue data and usage data are linked, and
explains how EPA will use these types of data in its dietary exposure
assessments. Bridging studies, which are used to quantify the
difference in residues resulting from various application rates, are
described in some detail. Also discussed are:
1. Residue decline studies, which can be used to quantify the
differences in residues resulting from various pre-harvest intervals
(PHIs).
2. Residue degradation studies, which characterize the decreasing
amounts of residues over time.
3. Cooking and processing data.
4. Market basket data.
5. Data to quantify residues in meat and milk after cooking and
pasteurization.
Finally, interested parties may provide existing and available data
of the types described in this document to EPA. The practical
experience of working with existing data will enable the Agency to
refine both current assessments and the guidance that is being
developed for conducting new studies.
IV. Questions/Issues for Comment
While comments are invited on any aspect of the draft policy paper,
EPA is particularly interested in comments on the following questions
and issues.
1. EPA proposes to review existing bridging, residue decline and
other data and to develop guidance for conducting these kinds of
studies. The purpose of these multi-rate, multi-PHI studies is to be
able to use the full range of expected residue values (based on the
full range of application rates and PHIs) in dietary exposure
assessments and thereby produce more realistic estimates of dietary
risk. Is this a reasonable and efficient approach? What other
approaches should EPA consider?
2. EPA believes that between one and three field trials conducted
at different locations (with three different application rates at each
field trial and three independent samples collected at each rate or
PHI) are needed to demonstrate the mathematical relationship between
application rate or PHI and amount of residue. Is this sampling regime
adequate to characterize the range of potential residues?
3. In developing its guidance, EPA has assumed that the
relationship between application rates and/or PHIs and resulting
residue levels is not necessarily the same for all chemicals. Is there
any information available to suggest that this assumption is incorrect?
Is there any information available to suggest that the relationship
between application rates and/or PHIs and resulting residue levels for
the organophosphates as a class may be similar?
4. EPA is willing to consider data on the prevalence of food
processing practices, along with data to quantify residue reductions
from such practices. Should information on the extent of food
processing practices be validated? If so, how could this be
accomplished?
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.
[[Page 16970]]
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 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
Documents that are referenced in this notice will be inserted in
the docket under the docket control number OPP-00591. 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: March 26, 1999.
Marylouise M. Uhlig,
Acting Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 99-8259 Filed 4-6-99; 8:45 am]
BILLING CODE 6560-50-F
