[Federal Register Volume 75, Number 213 (Thursday, November 4, 2010)]
[Pages 67963-67965]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27897]



[EPA-HQ-OPPT-2010-0877; FRL-8849-8]

Endocrine Disruptor Screening Program (EDSP); Announcing the 
Availability of a Draft for Weight-of-Evidence Guidance Document: 
Evaluating Results of EDSP Tier 1 Screening To Identify Candidate 
Chemicals for Tier 2 Testing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.


SUMMARY: EPA is announcing the availability for public review and 
comment of a draft guidance document titled, ``Weight-of-Evidence 
Guidance Document: Evaluating Results of EDSP Tier 1 Screening to 
Identify Candidate Chemicals for Tier 2 Testing.'' This action is in 
compliance with a directive from the House Appropriations Committee FY 
2010 Report directing the EPA to develop and publish criteria by 
October 30, 2010, for evaluating results of Tier 1 screening and 
determining whether a chemical should undergo Tier 2 analysis. The 
purpose of the weight-of-evidence (WoE) document is to set forth some 
of the general principles, criteria, and considerations EPA generally 
believes to be relevant under a WoE approach for evaluating data 
submitted as part of EPA's two-tiered paradigm for screening and 
testing chemicals for endocrine activity (i.e., estrogen, androgen, and 
thyroid hormonal systems; E, A, and T) under the EDSP. This document 
provides a transparent scientific approach for broadly evaluating Tier 
1 screening data to detect an interaction with E, A, and/or T hormonal 
systems and determine if additional Tier 2 testing is necessary.

DATES: Comments must be received on or before January 3, 2011.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2010-0877, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.

[[Page 67964]]

     Hand Delivery: OPPT Document Control Office 
(DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., 
Washington, DC. Attention: Docket ID Number EPA-HQ-OPPT-2010-0877. The 
DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding 
legal holidays. The telephone number for the DCO is (202) 564-8930. 
Such deliveries are only accepted during the DCO's normal hours of 
operation, and special arrangements should be made for deliveries of 
boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2010-0877. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: 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., 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.

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.


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 industrial or pesticide chemicals. To 
determine whether you or your business may be affected by this action, 
you should carefully examine section 408(p) of the Federal Food, Drug, 
and Cosmetic Act (FDCA) (21 U.S.C. 346a(p)) and the Safe Drinking Water 
Act (42 U.S.C. 300j-17). 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. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes 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 docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

[[Page 67965]]

II. Background

A. What action is the agency taking?

    EPA is announcing the availability of a draft guidance document 
titled, ``Weight-of-Evidence Guidance Document: Evaluating Results of 
EDSP Tier 1 Screening to Identify Candidate Chemicals for Tier 2 
Testing.'' This document invites the public to review and comment on 
the guidance document, which is available electronically at 
regulations.gov (http://www.regulations.gov) using docket ID number 
EPA-HQ-OPPT-2010-0877 and the EDSP Web site http://www.epa.gov/endo.
    This document was prepared to provide a transparent, scientific 
approach to set forth some general principles, criteria, and 
considerations EPA generally believes to be relevant using a WoE 
approach to evaluate data submitted as part of EPA's EDSP involving a 
battery of validated Tier 1 screening assays as described in a notice 
published in the Federal Register issue of October 21, 2009 (74 FR 
54415) (FRL-8432-6). The criteria discussed in this document are based, 
in part, on EPA's experience in developing and applying risk assessment 
guidelines involving cancer, reproductive and developmental toxicity, 
and ecological toxicity. Important considerations include the use of 
expert judgment formed through the scientific process, current 
understanding of endocrine mechanisms of toxicity, and knowledge of 
other fields of toxicology (e.g., developmental, reproductive, 
neurological and immunological toxicology, and toxicokinetics). 
Principles articulated in this document are equally applicable to a WoE 
evaluation of data from individual assays with multiple endpoints, as 
well as across the whole suite of assays in the EDSP Tier 1 screening 
battery. In addition, these principles would be generally applicable to 
the review of other scientifically relevant information (OSRI) 
submitted in response to test orders that request OSRI to be considered 
in lieu of designated screening assays in the Tier 1 battery.
    In general, the EDSP is a two-tiered paradigm for screening and 
testing chemicals with the potential to interact with the endocrine 
system. Tier 1 screening consists of a battery of complementary in 
vitro and short term in vivo assays designed to maximize sensitivity 
for detecting interactions with the E, A, and/or T hormonal systems; 
whereas, Tier 2 testing consists of a group of individual in vivo tests 
designed to include males and females with an intact hypothalamic-
pituitary-gonadal axis, multiple pathways of exposure and life-stages, 
and various taxa to further identify and characterize chemical-induced 
interactions with E, A, and/or T for risk assessment. The diversity in 
endocrine endpoints within and among the Tier 1 screening assays is 
expected to provide corroborating information and support a WoE 
evaluation to yield a decision as to whether or not the chemical 
indentified in Tier 1 requires additional testing in Tier 2.

B. What is the agency's authority for taking this action?

    Section 408(p) of FFDCA requires EPA to ``develop a screening 
program, using appropriate validated test systems and other 
scientifically relevant information, to determine whether certain 
substances may have an effect in humans that is similar to an effect 
produced by a naturally occurring estrogen, or such other endocrine 
effect as [EPA] may designate.'' (21 U.S.C. 346a(p)). The statute 
generally requires EPA to ``provide for the testing of all pesticide 
chemicals.'' (21 U.S.C. 346a(p)(3)). ``Pesticide chemical'' is defined 
as ``any substance that is a pesticide within the meaning of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), including 
all active and inert ingredients of such pesticide.'' (21 U.S.C. 

List of Subjects

    Environmental protection, Endocrine disruptors, Screening assays, 

    Dated: October 27, 2010.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution 
[FR Doc. 2010-27897 Filed 11-3-10; 8:45 am]