[Federal Register Volume 64, Number 66 (Wednesday, April 7, 1999)]
[Notices]
[Pages 16962-16965]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8636]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00593; FRL-6074-7]


Pesticides; Policy Issues Related to the Food Quality Protection 
Act

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.

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SUMMARY: To assure that EPA's policies related to implementing the Food 
Quality Protection Act (FQPA) are transparent and open to public 
participation, EPA is soliciting comments on a draft policy paper 
entitled ``Choosing a Percentile of Acute Dietary Exposure as a 
Threshold of Regulatory Concern.'' This notice is the seventh in a 
series concerning science policy documents related to FQPA and 
developed through the Tolerance Reassessment Advisory Committee (TRAC).
DATES: Written comments for this policy paper, identified by docket 
control number OPP-00593, should be submitted by June 7, 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.
FOR FURTHER INFORMATION CONTACT: Kathleen Martin, Environmental 
Protection Agency (7509C), 401 M St., SW., Washington, DC 20460. 
Telephone number: (703) 308-2857, fax: 703-305-5147, and 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 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 6034. 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'' section of this 
document. In addition, the official record for the science policy paper 
listed in the ``SUMMARY'' section of this document, including the 
public version, has been established under docket control number OPP-
00593 (including comments and data submitted electronically as 
described below). A public version of each record, including printed, 
paper versions of any electronic comments, which does not include any 
information claimed as Confidential Business Information (CBI), is 
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. Be sure to include docket control number OPP-00593 in 
your correspondence.
    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

[[Page 16963]]

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 accordance with 
procedures set forth in 40 CFR part 2. 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, please call 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. You can do this by providing the docket control number 
assigned to the notice, along with 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 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 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 five times as a full committee from May 27 through 
September 16, 1998.
    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 Unit I.C. of this 
document.

III. Summary of Draft Paper

     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 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 paper discusses how EPA applies the statutory 
safety standard to acute dietary risk assessments.
     The Environmental Protection Agency's Office of Pesticide Programs 
has previously announced that, on an interim basis, it intends to 
regulate

[[Page 16964]]

pesticides at the 99.9th percentile of the distribution of estimated 
acute dietary exposures when probabilistic assessment techniques are 
used to model the distribution. EPA will 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. This draft science policy paper describes OPP's 
interim policy, concerns that have been raised about it, associated 
public health issues, and OPP's plans for further evaluation and 
implementation. This policy has broad applicability to many pesticides 
and potentially significant impact on the assessment of these 
pesticides. Moreover, a number of concerns and issues have been raised 
about the policy. Therefore, the Agency is seeking public comment so 
that OPP policy is transparent and that the views of all interested 
parties are considered.
     OPP's interim position 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 dietary exposure (together 
with exposure from other non-dietary, non-occupational sources), as 
estimated by probabilistic (e.g., Monte Carlo) analysis, is equal to 
or less than the Population Adjusted Dose (PAD) for the pesticide, 
OPP will determine that the safety standard of FFDCA sec. 
408(B)(2)(A) is met with respect to acute dietary risk. However, if 
the analysis indicates that exposure at the 99.9th percentile 
exceeds the PAD, OPP will 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 will consider whether these values are 
representative and should be used as the primary basis for 
regulatory decision making. The Office will also examine the 
consequence of removing such high-end food consumption or residue 
values when estimating the 99.9th percentile of exposure.

     The first section of this paper provides an overview of OPP's 
present practice and interim policy for acute dietary risk assessment. 
It describes the statutory, regulatory and policy framework for this 
interim 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 
Estimating Model) work, as well as what input data sources are used and 
how.
     The second section addresses some of the specific issues and 
concerns raised about regulating at the 99.9th percentile. One issue is 
whether the nature of the databases available (i.e., robustness, 
adequacy, etc.) should preclude the use of the 99.9th percentile for 
regulatory purposes since some consider the uncertainties associated 
with this threshold of concern 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 databases, 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 paper summarizes these concerns and invites comment on 
them.
     The third section addresses the issue of protectiveness of the 
99.9th percentile with respect to the general public health. One view 
is that regulating at the 99.9th percentile 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 interim 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 as the view that, whether it over- or under-
estimates actual exposure, the 99.9th percentile is simply too 
uncertain to be used in risk management decisions. This section also 
explains that OPP considers 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, the aRfD; 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 aRfD. Finally, the OPP takes into account the 
degree of public health protection incorporated into the determination 
of the aRfD.
     The fourth section addresses the areas in which OPP and USDA 
propose to collaborate in performing further exploratory analysis with 
the DEEM software and the 99.9th percentile issue.
     The fifth and sixth sections list questions and issues on which 
the Agency would most like commenters to focus and respond, and provide 
a list of the documents referenced in this paper, respectively.
     The Appendix, entitled ``Primer on Interpretation of Exposure 
Distribution Curves,'' is a ``plain English'' guide to Monte Carlo 
analysis and how to interpret results from it.

IV. Questions/Issues for Comment

    While comments are invited on any aspect of the draft paper, EPA is 
particularly interested in comments on the following questions and 
issues.
    1. What are the appropriate statistical techniques for 
characterizing the uncertainty at the high end of the distribution of 
probabilistic exposure assessments? At what point does an exposure 
estimate become so uncertain that it would be inappropriate to use the 
estimate in regulatory decision making? How does uncertainty about one 
or more high-end values in a data set affect the reliability of the 
output of probabilistic models using that data set as an input?
    2. Regarding the Agency's current methodology for performing Monte 
Carlo analyses, at what percentile of estimated exposure is it 
appropriate for the Agency to establish its threshold of concern? 
99.99th, 99.9th, 99th, 95th, or some other percentile? What are the 
reasons for recommending that percentile? How should the 
characteristics of the data sets used as input to the assessment (e.g., 
the type of residue data, field trials vs. PDP monitoring data) affect 
the choice of a percentile exposure for OPP's threshold of concern?
    3. If OPP chooses to set its threshold of concern lower than the 
99.9th percentile, should any other steps, such as the application of 
an additional safety factor, be employed to assure that the statutory 
safety standard is satisfied?
    4. Some advocate a ``sliding regulatory scale'' with more serious 
toxic effects regulated at higher thresholds; they contend that such an 
approach would explicitly acknowledge all aspects of the risk 
management decision and incorporate the nature of the toxic effects and 
the built-in conservatism on the hazard identification and dose 
response side of the equation. Instead of regulating at only a single 
percentile for all toxicological effects (regardless of severity), 
should the Agency regulate pesticides at a variety of percentiles, 
depending upon the toxic effect

[[Page 16965]]

observed? For example, would a lower threshold of regulation (perhaps 
the 98th percentile) be warranted for fully-reversible effects (such as 
mild anemia) or would a more stringent threshold (perhaps the 99.9th 
percentile or higher) be justified for severe, non-reversible effects 
(e.g., birth defects)? Finally, should the Agency regulate pesticides 
at different percentiles according to the nature and size of the 
subpopulation groups (i.e., use the 99.9th percentile for larger groups 
and another percentile for smaller groups)?
    5. How should ``outliers'' be identified for food consumption data 
sets? For residue data sets? When an ``outlier'' is identified, how 
should the data point be handled in generating probabilistic exposure 
estimates?
    6. If OPP conducts a Critical Exposure Contribution (CEC) analysis, 
and excludes one or more data points because they appear to drive the 
high-end estimates of exposure, should OPP perform an additional CEC 
analysis on any revised estimate of the exposure distribution?
    7. Should OPP's probabilistic assessments attempt to reflect 
variability in human sensitivity to toxic effects, as suggested by the 
FIFRA Scientific Advisory Panel? If so, how should this be done?

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

    Document that are referenced in this notice will be inserted in the 
docket under the docket control number ``OPP-00593.'' 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: April 1, 1999.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 99-8636 Filed 4-6-99; 8:45 am]
BILLING CODE 6560-50-F