[Federal Register Volume 76, Number 188 (Wednesday, September 28, 2011)]
[Pages 60022-60023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-24893]

[[Page 60022]]



[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.


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: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; e-mail address: [email protected].


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 
     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 

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, 

[[Page 60023]]

    Dated: September 22, 2011.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution 
[FR Doc. 2011-24893 Filed 9-27-11; 8:45 am]