Pesticides; Policy Issues Related to the Food Quality Protection
Act
[Federal Register: May 26, 1999 (Volume 64, Number 101)]
[Notices]
[Page 28485-28487]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26my99-80]
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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: martin.kathleen@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:
------------------------------------------------------------------------
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: 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
[[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 (<greek-m> and <greek-s>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]
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