[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:

 
------------------------------------------------------------------------
                                                Examples of potentially
        Categories                NAICS            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. 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