[Federal Register Volume 65, Number 56 (Wednesday, March 22, 2000)]
[Notices]
[Pages 15330-15333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7126]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00593A; FRL-6484-5]


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 ``Choosing a Percentile 
of Acute Dietary Exposure as a Threshold of Regulatory Concern.'' This 
notice is the fifteenth in a series concerning science policy documents 
related to Food Quality Protection Act and developed through the 
Tolerance Reassessment Advisory Committee.

FOR FURTHER INFORMATION CONTACT: Kathleen Martin, Environmental 
Protection Agency (7509C), 401 M St., SW., 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
           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. The 
North American Industrial Classification System (NAICS) codes

[[Page 15331]]

have been provided to assist you and others in determining whether or 
not this action 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.

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 revised science policy document, 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/. The document entitled ``Responses to 
Public Comments on the Office of Pesticide Program's Draft Science 
Policy Document'' is available on EPA's Home Page with the Federal 
Register document at the above web site.
    2. Fax on demand. You may request a faxed copy of the revised 
science policy document, as well as supporting information, by using a 
faxphone to call (202) 401-0527. Select item 6046 for the document 
entitled ``Choosing a Percentile of Acute Dietary Exposure as a 
Threshold of Regulatory Concern.'' 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-00593A. 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 
(TRAC)

    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 the Office of Pesticide Programs (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 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 seven times as a full 
committee from May 27, 1998 through October 21, 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 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

    EPA is responsible for regulating the nature and amount of 
pesticide residues in food under FFDCA. FFDCA section 408 authorizes 
EPA to set a tolerance or

[[Page 15332]]

an exemption from the requirement of a tolerance if the Agency 
determines that the residues would be ``safe.'' The Agency performs 
various types of risk assessments to evaluate the safety of pesticides 
in food, including analyses to determine the nature and the amounts of 
pesticides that people might be exposed to over a single day. This 
science policy document discusses how EPA generally applies the 
statutory safety standard to acute dietary risk assessments as to 
pesticide residues in foods.
    The Environmental Protection Agency's Office of Pesticide Programs 
previously announced that, on an interim basis, it intended to use the 
99.9th percentile of the distribution of estimated acute dietary food 
exposures for calculating a threshold of concern when probabilistic 
assessment techniques are used to model the distribution. OPP stated 
that it would compare this percentile of estimated exposure to the 
Population Adjusted Dose (PAD), a value that reflects an amount of a 
pesticide to which a person may safely be exposed in one day. The 
Agency published a notice in the Federal Register on April 7, 1999 (64 
FR 16962) (FRL-6074-7), citing the availability of an interim policy 
and requested public comment so that the views of all interested 
parties would be considered (US EPA, 1999a).
    Based in part on the comments received, this science policy 
document was revised and is now being issued in its revised format. 
This revised document explains OPP's policy and details some of the 
various concerns that have been raised, additional associated public 
health-related issues, as well as OPP's plans for further evaluation 
and implementation. This policy has broad applicability to many 
pesticides and a potentially significant impact on the assessment of 
these pesticides.
    OPP's current approach with respect to assessing and regulating the 
food uses of pesticides, when using a probabilistic method of 
estimating acute dietary exposure, is as follows:
    If the 99.9th percentile of acute exposure from food, as estimated 
by probabilistic (e.g., Monte Carlo) analysis, is equal to or less than 
the acute Population Adjusted Dose (aPAD) for the pesticide, then OPP 
would generally consider its threshold of concern in applying that the 
safety standard of FFDCA section 408(B)(2)(A) not to be exceeded with 
respect to acute risk from food. However, if the analysis indicates 
that estimated exposure at the 99.9th percentile exceeds the PAD, OPP 
would generally conduct a sensitivity analysis to determine to what 
extent the estimated exposures at the high-end percentiles may be 
affected by unusually high food consumption or residue values. To the 
extent that one or a few values from the input data sets seem to 
``drive'' the exposure estimates at the high end of exposure, OPP would 
consider whether these values are representative and should be used as 
the primary basis for regulatory decision making. In either scenario, 
EPA would consider submissions by interested parties that question the 
appropriateness of the use of the 99.9th percentile in calculating the 
threshold of concern for the particular risk assessment in question or 
question its use generally.
    It is important to note here that the above position refers to the 
99.9th percentile of exposure and not consumption. The 99.9th 
percentile of exposure represents the joining of each individual's 
consumption data set with randomly selected residue values from the 
residue data set. The consumption values associated with the 99.9th 
percentile of exposure do not necessarily represent the 99.9th 
percentile of consumption since it is both the selected consumption 
value and residue concentration which is responsible for determining 
exposure.
    At this time, OPP's current policy is used only with daily 
exposures to a single chemical through the food pathway only. Estimates 
of exposure through drinking water and residential uses are not 
sufficiently developed to warrant inclusion in a probabilistic 
assessment. Establishing the threshold of concern for the food pathway 
using the 99.9th percentile of exposure is considered to be a ``first 
step'' toward regulation of exposures on an aggregate, and then 
cumulative, basis.
    OPP recognizes that different types of risk assessments will 
generally be needed for aggregate and cumulative evaluations and that 
these assessments might also be associated with different regulatory 
thresholds. Although OPP is moving toward regulating on the basis of 
probabilistic aggregate and cumulative exposure assessments, a decision 
has not yet been made regarding how the appropriate threshold of 
concern should be calculated for these types of assessments. When 
exposures through drinking water and residential uses are sufficiently 
refined to be incorporated into probabilistic evaluations, they will be 
aggregated and assessed, and may use a different population percentile.
    Section I of this provides an overview of OPP's present practice 
for acute dietary risk assessment for residues in food. It describes 
the statutory, regulatory, and policy framework for this policy, as 
well as prior reviews and comments. In addition, this section provides 
background information on dietary risk assessment in general and 
explains how the previous system (DRES--Dietary Risk Evaluation System) 
and the current system (DEEM--Dietary Exposure Evaluation Model) work, 
as well as what input data sources are used and how.
    Section II addresses some of the specific issues and concerns 
raised about using exposures at the estimated 99.9th percentile in 
calculating the threshold of concern. One issue is whether the nature 
of the data bases available (i.e., robustness, adequacy, etc.) should 
preclude the use of the estimated 99.9th percentile for regulatory 
purposes since some consider the uncertainties associated with this 
population percentile to be too great. Examples of data used are USDA's 
food consumption survey data, registrant crop field trials, USDA 
Pesticide Data Program (PDP) data, FDA monitoring data, market basket 
surveys, etc. Other issues include the treatment of data ``outliers,'' 
representativeness and adequacy of the data bases, and the impact of 
Agency default values on exposure estimates. Concerns, therefore, exist 
about whether the estimates of the 99.9th percentile of exposure are 
sufficiently representative of actual exposure to be meaningful. This 
science policy document summarizes these concerns and how OPP has 
addressed them.
    Section III addresses the issue of protectiveness of the estimated 
99.9th percentile of exposure with respect to the general public 
health. One view is that using the estimated 99.9th percentile of 
exposure is insufficiently conservative because very large numbers of 
people could be exposed every day to pesticide intakes which are 
estimated to exceed the Agency's ``level of concern.'' This section 
also explores the contrary view that the policy is over-protective 
because of the conservative assumptions used in the estimation methods 
and the retention of potentially unrepresentative values in the data 
base. The section discusses as well the view that, whether it over-
estimates or under-estimates actual exposure, the estimated 99.9th 
percentile of exposure is simply too uncertain to be used in risk 
management decisions.
    Section III also explains that OPP weighs a number of factors in 
considering which percentile to use: The size of the exposed population 
and the proportion that might receive daily doses above the benchmark 
of safety,

[[Page 15333]]

the aPAD; the level of confidence OPP has in its exposure estimates; 
and the extent to which such estimates may overstate potential exposure 
because they incorporate conservative assumptions or rely on atypical 
and unrealistic data. Further, to the extent understood, OPP considers 
by how much individual exposures would be estimated to exceed the aPAD.
    Section IV briefly addresses the issues associated with exploratory 
analysis conducted by OPP with the DEEM software and the 99.9th 
percentile issue. Further details and specifics of this analysis are 
provided in the associated response to public comments.
    Section V provides a list of the documents referenced in this 
science policy document.
    The Appendix, entitled ``Primer on Interpretation of Exposure 
Distribution Curves,'' is a ``plain English'' guide to Monte Carlo 
analysis and interpretation of its results.

IV. Issues Raised in Comments

    EPA published a draft version of the document described in Unit 
III. under SUPPLEMENTARY INFORMATION on April 7, 1999 (64 FR 16962) and 
comments were filed in docket control number OPP-00593. The public 
comment period ended on June 7, 1999. The Agency received comments from 
numerous different organizations. All comments were considered by the 
Agency in revising the document.
    Many of the comments were similar in content, and pertained to 
general issues concerning the proposed policy or specific sections 
within the draft document. The comments addressed a broad range of 
issues and, in many instances, provided no general consensus. The 
Agency grouped the comments according to the nature of the comment and 
the issue or section of the document which they addressed. For the 
substantive comments that follow, contrasting opinions are presented, 
along with EPA's response. The full text of the Agency's response to 
the comments is available as described in Units I.B.1. and I.B.2. under 
SUPPLEMENTARY INFORMATION.

V. Policies Not Rules

    The revised science 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 16, 2000
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
[FR Doc. 00-7126 Filed 3-21-00; 8:45 am]
BILLING CODE 6560-50-F