[Federal Register Volume 64, Number 101 (Wednesday, May 26, 1999)]
[Notices]
[Pages 28485-28487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13034]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00600; FRL-6081-6]


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 policy paper 
entitled ``Use of the Pesticide Data Program in Acute Dietary 
Assessment.'' This notice is the eighth in a series concerning science 
policy documents related to the Food Quality Protection Act and 
developed through the Tolerance Reassessment Advisory Committee.

DATES: Comments for this policy paper, identified by docket control 
number OPP-00600, must be received on or before July 26, 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. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-00600 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. Office 
location and telephone number: 1921 Jefferson Davis Highway (7509C), 
Arlington, VA, 22207; (703) 308-2857; fax: (703) 305-5147; 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 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 from the EPA Home Page under the 
Office of Pesticide Programs 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 6035. 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'' at the beginning 
of this document. In addition, the official record for the science 
policy paper listed in the ``SUMMARY'' at the beginnng of this 
document, including the public version, has been established under 
docket control number OPP-00600 (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. Public 
versions of these records, including printed, paper versions of any 
electronic comments, which do not include any information claimed as 
Confidential Business Information (CBI), are 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. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-00600 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

[[Page 28486]]

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, 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. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-00600 in the subject line on the 
first page of your response. You may also provide 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 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 
one of those draft documents as identified in the ``SUMMARY'' at the 
beginning of this document.

III. Summary of ``Use of the Pesticide Data Program (PDP) in Acute 
Dietary Assessment''

     The Environmental Protection Agency's (EPA) Office of Pesticide 
Programs (OPP) has identified a statistical methodology for applying 
existing information from the USDA Pesticide Data Program (PDP) report 
to risk assessments of the acute exposure to pesticide residues in 
food. This methodology consists of extrapolating from data on pesticide 
residues in composite samples of fruits and vegetables to residue 
levels in single units of fruits and vegetables. Given the composite 
sample mean (), the composite sample variance (S2), and the number of 
units in each composite sample, it is possible to estimate the mean and 
variance ( and 2) of the pesticide residues present 
on single units of fruits and vegetables. These parameters can then be 
applied to generate information on the level of residue in fruits and 
vegetables. This information can then be incorporated into a 
probabilistic exposure estimation model, such as the Monte Carlo 
method, in order to estimate exposure to pesticide residues in foods 
and the risk attendant to that exposure. This methodology has a higher 
degree of accuracy when more than 30 composite samples have detectable 
residues.
     Other organizations have developed similar methodologies for 
extrapolating from residue levels in composite samples to residue 
levels in single servings. These organizations include Sielken Inc. and 
Novigen Sciences, Inc. Because the methods developed by these two 
organizations originate from the same fundamental assumption that 
residues on individual serving sizes of fruits and vegetables follow a 
lognormal

[[Page 28487]]

distribution, their results are similar to those of OPP.
     OPP has recently started to apply the methodology described herein 
to estimate acute dietary exposure to pesticide residues in food. OPP 
is asking the FIFRA Scientific Advisory Panel and the public to answer 
specific questions regarding the methodology.

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. Measurements of many natural processes may be described by 
typical statistical distributions, e.g., normal, lognormal, etc. In 
previous data-fit studies, data on concentration of residues on fruits 
and vegetables have been fitted to a lognormal distribution. The 
lognormality of residues has been established as a fundamental 
assumption in the decomposition procedure. Please comment on the 
assumption of lognormality.
    2. The application of OPP's decomposition methodology calls for at 
least 30 ``detects.'' This is done to assure that there is enough 
representation in the sample and that the extrapolation will cover the 
width of the distribution of single servings. Although 30 detects is a 
practical rule for the application of the procedure, please comment on 
the consideration of other numbers as a practical rule of application.
    3. The standard deviation within a composite cannot be greater than 
the standard deviation of the population of individual residues. Are 
there any circumstances when this statement is not true? If so, what 
are these circumstances?
    4. OPP acknowledges that the collection of composite samples in the 
PDP protocol is not purely random; therefore, the decomposition 
procedure will produce an overestimation of the standard deviation of 
the lognormal distributions of residues on fruits and vegetables. 
Moreover, the overestimation of the standard deviation is accentuated 
to the degree that the collection of composite samples departs from 
pure randomness. The consequence of overestimating the standard 
deviation is that the high end of the estimates of residues in single 
serving size samples may exceed what occurs in reality. What criteria 
(if any) should be used to establish an upper-bound on the amount of 
residue projected in a single serving size sample to address the 
potential for overestimation of the standard deviation? How should the 
distribution of residues in single servings samples be interpreted when 
the PDP protocol does not assure that individual single servings 
samples are not randomly collected?
    5. OPP's methodology is sensitive to the number (N) of single 
units/servings of a commodity estimated to be in a composite sample. 
Please comment on how to estimate that number for different 
commodities. Consider how to handle fruits for which a single serving 
is typically only a part of a unit of a commodity (e.g., a melon) or 
many different units (e.g., grapes) even though the single serving is 
smaller than the typical composite sample.
    6. When there is considerable uncertainty about the number (N) of 
single units/servings of a commodity in a composite sample, should OPP 
generate several distributions of residues in single servings that 
encompass the possible range of values for N? Should these 
distributions in turn be used in DEEM to represent uncertainty in 
dietary exposure estimates?

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 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-00600.'' 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: May 12, 1999.

Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 99-13034 Filed 5-25-99; 8:45 am]
BILLING CODE 6560-50-F