[Federal Register Volume 65, Number 63 (Friday, March 31, 2000)]
[Notices]
[Pages 17266-17268]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7889]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00570A; FRL-6493-7]
Pesticides; Policy Issues Related to the Food Quality Protection
Act
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.
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SUMMARY: EPA is announcing the availability of the revised version of
the pesticide science policy document entitled ``Assigning Values to
Non-Detected/Non-Quantified Pesticide Residues.'' This notice is the
sixteenth in a series concerning science policy documents related to
the Food Quality Protection Act of 1996 and developed through the
Tolerance Reassessment Advisory Committee.
FOR FURTHER INFORMATION CONTACT: Kathleen Martin, Environmental
Protection Agency (7509C), Ariel Rios Bldg., 1200 Pennsylvania, Ave.,
NW., Washington, DC 20460; telephone number: (703) 308-2857; fax
number: (703) 305-5147; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture
or formulate pesticides. Potentially affected categories and entities
may include, but are not limited to:
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Examples of potentially
Categories NAICS 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. 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 action to a particular entity, consult the
person listed under ``FOR FURTHER INFORMATION CONTACT.''
[[Page 17267]]
B. How Can I Get Additional Information, Including Copies of this
Document or Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, the science policy documents, and certain other related
documents that might be available from the Office of Pesticide
Programs' Home Page at http://www.epa.gov/pesticides/. On the Office of
Pesticide Programs' Home Page select ``FQPA'' and then look up the
entry for this document under ``Science Policies.`` 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 to 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 the science
policy papers, as well as supporting information, by using a faxphone
to call (202) 401-0527. Select item 6047 for the paper entitled
``Assigning Values to Non-Detected/Non-Quantified Pesticide Residues.``
Select item 6048 for the paper entitled ``Responses to Public Comments
on the Office of Pesticide Program's Draft Science Policy Documents.``
You may also follow the automated menu.
3. In person. The Agency has established an official record for
this action under docket control number OPP-00570A. In addition, the
documents referenced in the framework notice, which published in the
Federal Register on October 29, 1998 (63 FR 58038) (FRL-6041-5) have
also been inserted in the docket under docket control number OPP-00557.
The official record consists of the documents specifically referenced
in this action, and other information related to this action, including
any information claimed as Confidential Business Information (CBI).
This official record includes the documents that are physically located
in the docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), 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 PIRIB telephone number is (703) 305-5805.
II. Background for the Tolerance Reassessment Advisory Committee
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 (OPP). 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 comprised
more than 50 representatives of affected user, producer, consumer,
public health, environmental, states and other interested groups. The
TRAC met seven times as a full committee from May 27, 1998 through
October 21, 1999.
The Agency worked 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 was 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 it believes
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), EPA is announcing through the Federal Register the availability
of a series of draft documents concerning nine science policy issues
identified by the TRAC related to the implementation of FQPA. After
receiving and reviewing comments from the public and others, EPA is
also issuing revised science policy documents which reflect changes
made in response to comments. In addition to comments received in
response to these Federal Register notices, EPA will consider comments
received during the TRAC meetings. Each of these issues is evolving and
in a different stage of refinement. Accordingly, as the issues are
further refined by EPA in consultation with USDA and others, they may
also be presented to the SAP.
III. Summary of Revised Science Policy Guidance Document
Residue data are used by the EPA's Office of Pesticide Programs to
support the establishment or reassessment of a pesticide tolerance
associated with a particular food use. In some cases, a portion of the
measurements of the levels of pesticide residue present on food shows
no detection of residues. These ``nondetects'' (NDs) do not necessarily
mean that the pesticide is not present at any level, but simply that
any amount of pesticide present is below the level that could be
detected or reliably quantified using a particular analytical method.
[[Page 17268]]
The primary science policy issue concerning NDs is what value the
EPA should assign to them when estimating dietary exposure and risk
from a pesticide. The reason this is an important issue stems from the
new requirements that the FQPA impose on EPA. Among other things, FQPA
established a stringent health-based standard (``a reasonable certainty
of no harm'') for pesticide residues in foods to assure protection of
the public health, including sensitive populations such as infants and
children, from unacceptable pesticide exposure and risks. OPP's goal is
to make exposure and risk assessments as accurate and realistic as
possible while not underestimating exposure or risk, so that all
humans, including infants and children, are fully protected. The
specific issues addressed in this paper concern the values the Agency
should assign to NDs in order to meet this goal.
In general, the OPP recommends use of a default value of \1/2\ the
Limit of Detection (LOD) or \1/2\ the Limit of Quantitation (LOQ) for
commodities which have been treated but for which no detectable
residues are measured. This paper also describes the OPP's policy of
performing a ``sensitivity analysis'' to determine the impact of using
different assumptions (e.g., assuming NDs = full LOD or full LOQ versus
NDs = zero), on the OPP's risk assessment for the pesticide under
evaluation. If it is demonstrated through the sensitivity analysis that
the default assumptions have no effect on the final OPP risk decision,
then there is little reason for OPP to attempt to further refine these
default assignments.
If OPP finds that these default assignments do have a significant
effect on the risk estimate or risk decision or decides that a more
refined risk estimate is needed, a second set of statistical methods
can be used instead to determine the values or distribution of values
for NDs. These statistical methods provide a more accurate way of
estimating dietary exposure and risk than assuming that, for NDs,
exposure occurs at \1/2\ LOD or some other single, finite value and
allowing risk assessors to impute a series of values which represent
concentrations below the stated detection limit. These methods would
generally be used only in situations where the NDs comprise a
significant (but less than half) portion of the data set and the rest
of the data are normally or lognormally distributed, but exceptions can
be considered on a case-by-case basis.
This revised document was developed from two previous draft
documents entitled ``Assigning Values To Nondetected/Nonquantified
Pesticide Residues into Human Health Dietary Exposure
Assessments''(docket control number OPP-00570) and ``A Statistical
Method for Incorporating Nondetected Pesticide Residues into Human
Health Dietary Exposure Assessments'' (docket control number OPP-00571)
that were released for public comment December 4, 1998 (63 FR 67063)
(FRL-6048-2). The Agency received comments from various organizations.
Each of the commenters offered recommendations for improving the
science policy. All comments were extensively evaluated and considered
by the Agency. This revised version embodies many of the sentiments and
recommendations of the commenters. A summary of the public comments, as
well as the Agency's response to the comments, are being made available
as described in Units I.B.1. and I.B.2.
IV. Policies Not Rules
The 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.
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests.
Dated: March 23, 2000.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 00-7889 Filed 3-30-00; 8:45 am]
BILLING CODE 6560-50-F