[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: 
[email protected].

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]]



 
------------------------------------------------------------------------
                                                        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. 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: [email protected]. 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