[Federal Register Volume 76, Number 188 (Wednesday, September 28, 2011)]
[Notices]
[Pages 60022-60023]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24893]
[[Page 60022]]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2010-0877; FRL-8890-7]
Endocrine Disruptor Screening Program; Weight-of-Evidence
Guidance Document; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA's Endocrine Disruptor Screening Program (EDSP) is
announcing the availability of a final guidance document titled,
``Weight-of-Evidence: Evaluating Results of EDSP Tier 1 Screening to
Identify the Need for Tier 2 Testing.'' This weight-of-evidence (WoE)
guidance document was revised based on public and peer review comments
and existing peer-reviewed EPA guidelines. This guidance document
provides basic principles and criteria for application of a WoE
approach to evaluate results from the battery of Tier 1 screening
assays along with other scientific and technical information relevant
to Tier 1 screening to determine whether or not a chemical has the
potential to interact with the estrogen, androgen, or thyroid (E, A, or
T) hormonal pathways of the endocrine system. The combined results and
information will also be used to identify which tests and information
may be needed for Tier 2 testing.
FOR FURTHER INFORMATION CONTACT: For technical information contact: Don
Bergfelt, Office of Science Coordination and Policy (7203M),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-8472; e-mail
address: bergfelt.don@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public in general. You may be
potentially affected by this action if you produce, manufacture, use,
consume, work with, or import pesticide chemicals. To determine whether
you or your business may be affected by this action, you should
carefully examine section 408(p) of FFDCA, 21 U.S.C. 346a(p).
Potentially affected entities may include, but are not limited to:
Chemical manufacturers, importers and processors (NAICS
code 325), e.g., persons who manufacture, import or process chemical
substances.
Pesticide, fertilizer, and other agricultural chemical
manufacturers (NAICS code 3253), e.g., persons who manufacture, import
or process pesticide, fertilizer and agricultural chemicals.
Scientific research and development services (NAICS code
5417), e.g., persons who conduct testing of chemical substances for
endocrine effects.
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 in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I get a copy of this document and other related information?
EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPPT-2010-0877; FRL-8890-7. All
documents in the docket are listed in the docket index available at
http://www.regulations.gov. Although listed in the index, some
information is not publicly available, e.g., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, will
be publicly available only in hard copy. Publicly available docket
materials are available electronically at http://www.regulations.gov,
or, if only available in hard copy, at the OPPT Docket. The OPPT Docket
is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West
Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public
Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number of the
EPA/DC Public Reading Room is (202) 566-1744, and the telephone number
for the OPPT Docket is (202) 566-0280. Docket visitors are required to
show photographic identification, pass through a metal detector, and
sign the EPA visitor log. All visitor bags are processed through an X-
ray machine and subject to search. Visitors will be provided an EPA/DC
badge that must be visible at all times in the building and returned
upon departure.
II. Overview of Revision Process
The Agency submitted a draft WoE guidance document for evaluating
the results of EDSP Tier 1 screening for public review and comment as
described in a Federal Register notice issued November 4, 2010 (75 FR
67963) (FRL-8849-8). Initially the commenting period was for 60 days,
but was extended for an additional 30 days following a request from the
chemical industry. Public comments were compiled and grouped according
to the commonality among individual submissions so that they could be
more readily and fully considered by EPA during revision of the WoE
document. Comments were provided to the Agency from 13 different
affiliations that mostly included the chemical industry as well as
research organizations, and environmental and animal welfare advocates.
In general, there were four main categories of comments considered
relevant to the WoE guidance document that requested additional detail
and clarification of the following:
1. Tier 1 battery of assays.
2. Assay endpoints.
3. Other scientifically relevant information.
4. WoE analysis.
The Agency considered specific comments within these categories and
revised respective sections in the document. The Agency also considered
peer review comments received from senior scientists across EPA with
expertise in toxicology, reproductive physiology, and endocrinology
encompassing health and ecological effects and made revisions. Also
incorporated into the revised document are the fundamental principles
and criteria for weighing and integrating different lines of evidence
in a WoE evaluation articulated in existing peer-reviewed EPA
guidelines. The Agency acknowledges the contribution that public and
peer review comments have had in helping to expand the quantity and
enhance the quality of guidance provided in this final version of the
WoE document that will assist in evaluating the results of EDSP Tier 1
screening to identify the need for Tier 2 testing.
List of Subjects
Environmental protection, Endocrine disruptors, Screening assays,
Weight-of-evidence.
[[Page 60023]]
Dated: September 22, 2011.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2011-24893 Filed 9-27-11; 8:45 am]
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