[Federal Register Volume 64, Number 134 (Wednesday, July 14, 1999)]
[Notices]
[Pages 37977-37980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-17318]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00609; FRL-6088-6]


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 soliciting comments on a draft science policy 
paper entitled ``The Role of Use-Related Information in Pesticide Risk 
Assessment and Risk Management.'' This notice is the tenth in a series 
concerning science policy documents related to the Food Quality 
Protection Act and developed through the Tolerance Reassessment 
Advisory Committee.

DATES: Written comments, identified by docket control number OPP-00609 
should be submitted by September 13, 1999.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as

[[Page 37978]]

provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION'' section. To 
ensure proper receipt by EPA, your comments must identify docket 
control number OPP-00609 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: Debby Sisco, Environmental Protection 
Agency (7503C), 401 M St., SW., Washington, DC 20460, telephone number: 
(703) 308-8121; fax: (703) 305-8091; e-mail address: 
[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:

 
------------------------------------------------------------------------
                                                         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 person listed in the ``FOR FURTHER INFORMATION CONTACT'' 
section.

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 draft science policy paper 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 at http://www.epa.gov/
fedrgstr/.
    2. Fax on demand. You may request a faxed copy of this document, as 
well as supporting information, by using a faxphone to call (202) 401-
0527 and selecting item 6039. 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 technical 
person identified in the ``FOR FURTHER INFORMATION CONTACT'' section. 
In addition, the official record for the draft science policy paper 
listed in the ``SUMMARY'' section, including the public version, has 
been established under docket control number OPP-00609 (including 
comments and data submitted electronically as described below). This 
record not only includes the documents that are physically located in 
the docket, but also includes all the documents that are referenced in 
those documents. 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 the 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, you must identify 
docket control number OPP-00609 in the subject line on the first page 
of your response.
    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. 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 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. The 
PIRIB 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

[[Page 37979]]

can do this by providing docket control number OPP-00609, 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 
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 believed 
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 several more draft policy documents which are 
related to the implementation of FQPA, but which are not purely science 
policy issues. This notice announces the availability of a draft 
document as identified in the ``SUMMARY'' section.

III. Summary of ``The Role of Use-Related Information in Pesticide 
Risk Assessment and Risk Management''

    In assessing the risks of pesticides and in making risk management 
(regulatory) decisions, EPA uses a wide range of data and information, 
such as how each pesticide is applied, where it is used, and how much 
is actually used. This paper summarizes the types of use-related 
information used by EPA in risk assessment and risk management, where 
the data come from, and how the Agency employs these data.
    EPA pesticide use data come from a variety of sources for both 
agricultural and non-agricultural pesticides use sites. There are three 
general categories of methods for obtaining use data: Agreements with 
other regulatory entities that produce pesticide-use data; purchases 
from vendors whose business is to obtain pesticide-use data; and 
voluntary submissions of data from interested parties who have 
developed such data.
    EPA also obtains use information from a variety of interested 
parties. For example, registrants who are going through the special 
review and/or reregistration process may have submitted data in support 
of a new use, risk mitigation, or in support of a registrant sponsored 
risk study. Individual states submit data in support of emergency 
exemption (FIFRA section 18) requests. Growers and food processors have 
also submitted use data. Additionally, state departments of 
agriculture, as part of their extension program efforts, provide use 
data or pesticide use recommendations for crops grown under their 
jurisdictions.
    The kinds of pesticide use information which risk assessors use in 
developing human dietary risk assessments are equally important to 
those who develop drinking water and ecological risk assessments. This 
use-related information is used to assess human exposure to pesticides 
in drinking water; to assess fish and wildlife exposure to pesticides; 
and to interpret monitoring results and develop models that can be used 
to accurately estimate pesticide concentrations in drinking water and 
surface and ground water.
    Use-related information plays a vital, even critical role in EPA's 
formulation of risk management decisions for pesticides in 
registration, reregistration, tolerance reassessment, and special 
review. The availability or lack of use-related information can 
significantly influence the outcome of EPA's regulatory decisions about 
pesticides under review, especially if they pose significant risks.
    The way in which use information has been incorporated into risk 
assessments has changed since the passage of the Food Quality 
Protection Act in 1996. EPA has been working to enhance its pesticide 
use data base by working more closely with the U.S. Department of 
Agriculture, California EPA, registrants, and grower groups as well as 
other stakeholders. The draft science policy paper lists projects EPA 
is currently working on for this purpose.

IV. Questions/Issues for Comment

    While comments are invited on any aspect of the draft science 
policy paper, EPA is particularly interested in comments on the 
following questions and issues.
    1. Is the EPA's description of the kinds of use and usage data 
obtained and evaluated by EPA complete? Are

[[Page 37980]]

there other data or sources which the Agency should consider?
    2. Are the ways in which usage data are employed in risk assessment 
and risk management of pesticides clear?

V. Policies Not Rules

    Each 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 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 docket control number OPP-00609. 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: June 29, 1999.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 99-17318 Filed 7-13-99; 8:45 am]
BILLING CODE 6560-50-F