Pesticides; Determination of the Appropriate FQPA Safety Factor(s) in Tolerance Assessment

 [Federal Register: February 28, 2002 (Volume 67, Number 40)]
[Notices]
[Page 9271-9273]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28fe02-62]

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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00757; FRL-6820-6]
 
Pesticides; Determination of the Appropriate FQPA Safety 
Factor(s) in Tolerance Assessment

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

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SUMMARY: EPA announces the availability of the revised version of the 
pesticide science policy document entitled ``Determination of the 
Appropriate FQPA Safety Factor(s) in Tolerance Assessment.'' This 
notice is one in a series concerning science policy documents related 
to the implementation of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

FOR FURTHER INFORMATION CONTACT: Vicki Dellarco, Environmental 
Protection Agency (7503C), 1200 Pennsylvania Ave., NW., Washington, DC 
20460; telephone number: (703) 305-1803; fax number: (703) 305-5147-; 
e-mail address: dellarco.vicki@epa.gov.

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 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.

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,''`` Regulations and 
Proposed Rules,'' 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. In person. The Agency has established an official record for 
this action under docket control number OPP-00757. In addition, the 
documents

[[Page 9272]]

referenced in the framework notice, which published in the Federal 
Register on October 29, 1998 (63 FR 58038) (FRL-6041-5) under docket 
control number OPP-00557, are considered as part of the official record 
for this action under docket control number OPP-00757 even though not 
placed in the official record. 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 Hwy., 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 Information

    On August 3, 1996, FQPA was signed into law. The FQPA significantly 
amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
and 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 and strengthened health protections for infants and children 
from pesticide risks.
    Thereafter, 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 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 meet the new FFDCA standard, but that could be revisited if 
additional information became available or as the science evolved. In 
addition, the Agency seeks independent review and public participation, 
generally through presentation of the science policy issues to the 
FIFRA Scientific Advisory Panel, a group of independent, outside 
experts who provide peer review and scientific advice to OPP.
    During 1998 and 1999, EPA and the U.S. Department of Agriculture 
(USDA) established a second subcommittee of NACEPT, the Tolerance 
Reassessment Advisory Committee (TRAC) to address FFDCA 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 from May 27, 1998, through April 
29, 1999.
    In order to continue the constructive discussions about FFDCA, EPA 
and USDA have established, under the auspices of NACEPT, the Committee 
to Advise on Reassessment and Transition (CARAT). The CARAT provides a 
forum for a broad spectrum of stakeholders to consult with and advise 
the Agency and the Secretary of Agriculture on pest and pesticide 
management transition issues related to the tolerance reassessment 
process. The CARAT is intended to further the valuable work initiated 
by the FSAC and TRAC toward the use of sound science and greater 
transparency in regulatory decisionmaking, increased stakeholder 
participation, and reasonable transition strategies that reduce risks 
without jeopardizing American agriculture and farm communities.
    As a result of the 1998 and 1999 TRAC process, EPA decided that the 
implementation process and related policies would benefit from 
providing notice and comment on major science policy issues. The TRAC 
identified nine science policy areas it believed were key to 
implementation of tolerance reassessment. EPA agreed to provide one or 
more documents for comment on each of the nine issues by announcing 
their availability in the Federal Register. In a notice published in 
the Federal Register of October 29, 1998 (63 FR 58038), EPA described 
its intended approach. Since then, EPA has been issuing a series of 
draft documents concerning the nine science policy issues. This notice 
announces the availability of the revised science policy document 
concerning the FPQA safety factor.

III. Summary of ``Determination of the Appropriate FQPA Safety 
Factor(s) in Tolerance Assessment''

    On August 3, 1996, the Food Quality Protection Act of 1996 was 
signed into law, significantly amending the Federal Insecticide, 
Fungicide, and Rodenticide Act and the Federal Food, Drug, and Cosmetic 
Act. Among other changes, the new law provides heightened protections 
for infants and children, directing EPA, in setting pesticide 
tolerances, to use an additional tenfold margin of safety to protect 
infants and children, taking into account the potential for pre- and 
postnatal toxicity and the completeness of the toxicology and exposure 
databases. The statute authorizes EPA to replace this tenfold FQPA 
safety factor with a different FQPA factor only if reliable data 
demonstrate that the resulting level of exposure would be safe for 
infants and children.
    EPA established a Task Force of senior scientists, knowledgeable in 
the fields of hazard and exposure assessment, to help it identify the 
types of information that would be appropriate for evaluating the 
safety of pesticides for infants and children. The Task Force included 
representatives from the Agency's Office of Prevention, Pesticides and 
Toxic Substances, Office of Research and Development, Office of 
Children's Health Protection, Office of Water, and Office of Solid 
Waste and Emergency Response. The Task Force made many useful 
recommendations considered by the Office of Pesticide Programs during 
the development of this guidance. Comments from the public and from the 
FIFRA Scientific Advisory Panel also contributed to this document.
    This document describes how the Office of Pesticide Programs (OPP) 
determines the appropriate FQPA safety factor(s) when developing 
aggregate risk assessments and regulatory decisions for single active 
and ``other'' (i.e., inert) ingredients of pesticide products. The 
guidance is specifically addressed to OPP risk assessors but also 
serves as an important source of information for the public and the 
regulated community. This guidance explains the legal framework for the 
FQPA safety factor and key interpretations of statutory terms (See 
Appendix 1) and describes how the FQPA safety factor provision both 
formalizes and expands OPP's past practice of applying uncertainty 
factors to account for deficiencies in the toxicological database. 
Because this guidance only addresses the statutory provisions of FQPA, 
it does not apply to any of the Agency's other regulatory programs or 
risk assessment processes which are carried out under different 
statutory authorities. As explained below, this guidance explains how 
OPP intends to ``take into account...potential pre- and post-natal 
toxicity and completeness of the data with respect to exposure and 
toxicity to infants and children'' as directed by FFDCA Section 
408(b)(2)(C)(i).

[[Page 9273]]

    A primary consideration in implementation of the FQPA safety factor 
provision is assessing the degree of concern regarding the potential 
for pre- and postnatal effects. In many cases, concerns regarding pre- 
and postnatal toxicity can be addressed by calculating a Reference Dose 
(RfD) or Margin of Exposure (MOE) from the pre- or postnatal endpoints 
in the offspring and traditional uncertainty factors (i.e., use of a 
factor to account for estimating a No-Observed-Adverse-Effect-Level 
from a Lowest-Observed Adverse-Effect-Level, estimating chronic effects 
from a subchronic study, and an incomplete toxicology data base) are 
fully considered. In some instances, however, data may raise 
uncertainties or a high concern for infants or children which cannot be 
addressed in the derivation of an RfD or MOE. OPP intends to analyze 
the degree of concern and to assess the weight of all relevant evidence 
for each case. This involves examining the level of concern for 
sensitivity/susceptibility and assessing whether traditional 
uncertainty factors already incorporated into the risk assessment are 
adequate to protect the safety of infants and children, as well as the 
adequacy of the exposure assessment.
    The guidance also explains how data deficiency uncertainty factors 
will be used to address the FQPA safety factor provision's expressed 
concern as to the ``completeness of the data with respect to ... 
toxicity to infants and children...'' The FQPA safety factor provision 
regarding the completeness of the toxicity database is similar to the 
traditional data deficiency uncertainty factors used by the Agency to 
address inadequate or incomplete data. Thus, when deriving RfDs and 
evaluating the protection provided by FQPA safety factors, OPP intends 
to consider current Agency practice regarding data deficiency 
uncertainty factors.
    Another important consideration for the FQPA safety factor is the 
completeness of the exposure database. Whenever appropriate data are 
available, OPP estimates exposure using reliable empirical data on 
specific pesticides. In other cases, exposure estimates may be based on 
models and assumptions (which in themselves are based on other reliable 
empirical data). This document explains how, in the absence of case 
specific exposure data, OPP will evaluate the safety of the exposure 
estimate as to infants and children and correspondingly, the 
appropriate FQPA safety factor.
    Finally, the decision to retain the default 10X FQPA safety factor 
or to assign a different FQPA safety factor is informed by the 
conclusions presented in the risk characterization, and is not 
determined as part of the RfD process. This guidance document describes 
the integrated approach used when making FQPA safety factor decisions. 
This is a ``weight-of-the-evidence'' approach in which all of the data, 
concerning both hazard and exposure, are considered together for the 
pesticide under evaluation. The FQPA safety factor determination 
includes an evaluation of the level of confidence in the hazard and 
exposure assessments and an explicit judgement of whether there are any 
residual uncertainties identified in the risk characterization. It is 
at this integration stage that OPP determines how the completeness of 
the toxicology and exposure databases and the potential for pre and 
postnatal toxicity were handled in the risk assessment.

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 not be 
applied.

List of Subjects

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests.

    Dated: February 20, 2002.
Stephen L. Johnson,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
[FR Doc. 02-4793 Filed 2-27-02; 8:45 a.m.]
BILLING CODE 6560-50-S
Pesticides; Determination of the Appropriate FQPA Safety Factor(s) in Tolerance Assessment

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