Pesticides; Consideration of the FQPA and Other Safety Factors in Cumulative Risk Assessment

Note: EPA no longer updates this information, but it may be useful as a reference or resource.
 [Federal Register: February 28, 2002 (Volume 67, Number 40)]
[Notices]
[Page 9273-9276]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28fe02-63]

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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00759; FRL-6822-3]
 
Pesticides; Consideration of the FQPA and Other Safety Factors in 
Cumulative Risk Assessment

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 of 1996 (FQPA) are transparent and open to 
public participation, EPA is soliciting comments on the pesticide draft 
science policy document titled, ``Consideration of the FQPA Safety 
Factor and Other Uncertainty Factors in Cumulative Risk Assessment of 
Chemicals Sharing a Common Mechanism of Toxicity.'' 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 FQPA.

DATES: Comments for the draft science policy document, identified by 
docket control number OPP-00759, must be received on or before April 
29, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper 
receipt by EPA, it is imperative that you identify docket control 
number OPP-00759 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: Randy Perfetti, Health Effects 
Division (7509C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-5381; e-mail address: 
perfetti.randolph@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 codes         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

[[Page 9274]]

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 draft 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,'' ``Regulations and 
Proposed Rules,'' and then look up the entry for 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 draft science 
policy document, as well as supporting information, by using a faxphone 
to call (202) 401-0527. Select item 6050 for the document titled 
``Consideration of the FQPA Safety Factor and Other Uncertainty Factors 
in Cumulative Risk Assessment of Chemicals Sharing a Common Mechanism 
of Toxicity.'' 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-00759. In addition, the 
documents referenced in the framework notice, which published in the 
Federal Register of 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-00759 even 
though not placed in the official record. The official record consists 
of the documents specifically referenced in this action, and any public 
comments received during an applicable comment period, 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.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-00759 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania, Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The PIRIB 
telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: opp-docket@epa.gov, or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in WordPerfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number OPP-00759. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA 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. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person listed under FOR FURTHER INFORMATION CONTACT.

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 documents, 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. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-00759 in the subject line on the 
first page of your response. You may also provide the name, date, and 
Federal Register citation.

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 the 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

[[Page 9275]]

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 decision-making, 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 a pesticide draft science policy document 
concerning the Agency's use of the FQPA safety factor in cumulative 
risk assessments.

III. Summary of Draft Document

    The guidance document provides the current thinking of OPP on 
application of the provision in FFDCA section 408(b)(2)(C), regarding 
an additional safety factor for the protection of infants and children 
in the context of cumulative risk assessments. OPP, in an earlier 
science policy paper for individual chemicals, addressed how its risk 
assessments will consider the FQPA safety factor provision for 
individual chemicals (EPA, 1999, and EPA, 2002a). Additionally, OPP has 
prepared guidance on how to conduct a cumulative risk assessment for 
two or more pesticides sharing a common mechanism of toxicity (EPA, 
2002b). Each of these papers provided some general information and 
guidance on the FQPA safety factor, but did not address in detail the 
application of the FQPA safety factor provision on cumulative risk 
assessment.
    OPP has developed the current document to provide a more expansive 
discussion of the use of uncertainty and safety factors in the context 
of cumulative risk assessment and to restructure its presentation to 
follow more closely the framework and terminology presented in the FQPA 
safety factor guidance for individual chemicals (EPA, 2002a). This 
document also draws on definitions contained in the revised cumulative 
risk assessment guidance, which has been revised and issued (EPA, 
2002b).
    OPP believes that it is critical to the protection of infants and 
children that it not rely on and not apply a default value or 
presumption in making decisions under section 408 where reliable data 
are available that support use of a different safety factor in the 
assessment of risk. Use of the default value may result in an under-or 
over-statement of risk. OPP's reasoning applies with even more force in 
the context of cumulative risk assessments due to the additional 
complexities involved. Accordingly, for cumulative risk assessments, 
OPP also intends to make specific case-by-case determinations as to the 
size of the additional FQPA safety factor rather than rely on the 10X 
default value if reliable data permit. Further, this individualized 
determination may involve application of FQPA safety factors to both 
the individual chemical members as well as to the entire cumulative 
assessment group (referred to as the ``CAG'') of common mechanism 
chemicals. This guidance document focuses primarily on the 
considerations relevant to determining a safety factor ``different'' 
than the default 10X that protects the safety of infants and children.

V. Policies Not Rules

    The draft 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.
    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.

List of Subjects

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

[[Page 9276]]

    Dated: February 20, 2002.
  Stephen L. Johnson,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
[FR Doc. 02-4794 Filed 2-27-02; 8:45 am]
BILLING CODE 6560-50-S
Pesticides; Consideration of the FQPA and Other Safety Factors in Cumulative Risk Assessment

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