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Endocrine Disruptor Screening Program; Workshop to Discuss Draft Policies and Procedures 

[Federal Register: November 23, 2007 (Volume 72, Number 225)]
[Notices]
[Page 65732-65733]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23no07-69]

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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2007-1080; FRL-8341-3]

Endocrine Disruptor Screening Program; Workshop to Discuss Draft
Policies and Procedures

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

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SUMMARY: EPA is convening a 1-day public workshop to discuss the
Agency's draft administrative policies and procedures for completing
the initial screening and testing under EPA's Endocrine Disruptor
Screening Program (EDSP) and the burden and cost estimates for the
related information collection activities. In two forthcoming notices
in the Federal Register, EPA will announce the availability for public
review and comment of: (1) The draft policies and procedures EPA is
considering adopting for conducting the initial screening and testing
under the EDSP and (2) the draft Information Collection Request (ICR)
for the initial screening and testing. The purpose of the public
workshop is to allow the public to ask questions and for EPA to provide
further explanation about these aspects of the EDSP, which in turn may
facilitate the preparation of comments.

DATES: The meeting is on Monday, December 17, 2007, from 9 a.m. to 5 p.m.
    Special accommodations: For information on access or services for
individuals with disabilities, and to request accommodation of a
disability, please contact the person listed under FOR FURTHER
INFORMATION CONTACT at least 10 days prior to the meeting to give EPA
as much time as possible to process your request.

ADDRESSES: The meeting will be held at the Environmental Protection
Agency, Conference Center--Lobby Level, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA 22202.

FOR FURTHER INFORMATION CONTACT: William Wooge, Office of Science
Coordination and Policy (OSCP), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 546-8476; e-mail address: wooge.william@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Who Should Attend?

    You may be interested in attending this workshop if you produce,
manufacture, use, or import pesticide/agricultural chemicals and other
chemical substances; or if you are or may otherwise be involved in the
testing of chemical substances for potential endocrine effects. To
determine whether you or your business may have an interest in this
workshop you should carefully examine section 408(p) of the Federal,
Food, Drug, and Cosmetic Act (FFDCA). [21 U.S.C. 346a(p)]

II. What is the EDSP?

    The EDSP was established in 1998 to carry out the mandate in
section 408(p) of FFDCA [21 U.S.C. 346a et. seq.],

[[Page 65733]]

which directed EPA ``to develop a screening program . . . 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 the Administrator may designate.'' If a substance
is found to have an effect, FFDCA section 408(p)(6) directs the
administrator to take action under available statutory authority to
ensure protection of public health. That is, the ultimate purpose of
the EDSP is to provide information to the Agency that will allow the
Agency to evaluate the risks associated with the use of a chemical and
take appropriate steps to mitigate any risks. The necessary information
includes identifying any adverse effects that might result from the
interaction of a substance with the endocrine system and establishing a
dose-response curve. Section 1457 of the Safe Drinking Water Act (SDWA)
also authorizes EPA to screen substances that may be found in sources
of drinking water, and to which a substantial population may be
exposed, for endocrine disruption potential. [42 U.S.C. 300j-17]
    EPA currently is implementing its EDSP in three major parts that
are being developed in parallel and with substantial work on each well
underway. This document announces a public workshop related
specifically to the third component of the EDSP (i.e., policies and
procedures). The three parts are briefly summarized as follows:
    1. Assay validation. Under FFDCA section 408(p), EPA is required to
use ``appropriate validated test systems and other scientifically
relevant information'' to determine whether substances may have
estrogenic effects in humans. EPA is validating assays that are
candidates for inclusion in the Tier 1 screening battery and Tier 2
tests, and will select the appropriate screening assays for the Tier 1
battery based on the validation data. Validation is defined as the
process by which the reliability and relevance of test methods are
evaluated for the purpose of supporting a specific use. The status of
each assay can be viewed on the EDSP website in the Assay Status table: 
http://www.epa.gov/scipoly/oscpendo/pubs/assayvalidation/status.htm.
In addition, on July 13, 2007, EPA published a Federal
Register document that outlined the approach EPA intends to take for
conducting the peer reviews of the Tier 1 screening assays and Tier 2
testing assays and EPA's approach for conducting the peer review of the
Tier 1 battery (72 FR 38577) (FRL-8138-4). EPA also announced the
availability of a ``list server'' (Listserv) that will allow interested
parties to sign up to receive e-mail notifications of EDSP peer review
updates, including information on the availability of peer review
materials to be posted on the EDSP website.
    2. Priority setting. EPA described its priority setting approach to
select pesticide chemicals for initial screening on September 27, 2005
(70 FR 567449) (FRL-7716-9), and announced the draft list of initial
pesticide active ingredients and pesticide inerts to be considered for
screening under FFDCA on June 18, 2007 (72 FR 33486) (FRL-8129-3). The
Agency expects to finalize this initial list of chemicals before
screening is initiated in 2008. More information on EPA's priority
setting approach and the draft list of chemicals is available at
www.epa.gov/scipoly/oscpendo/prioritysetting. The first 73 pesticide
chemicals to undergo screening is also referred to as ``initial
screening'' in this document.
    3. Policies and procedures. A forthcoming Federal Register document
will describe EPA's draft policies relating to:
    • The procedures that EPA is considering using to issue orders.
    • How joint data development, cost sharing, data
compensation, and data protection would be addressed.
    • Procedures that order recipients would use to respond to an order.
    • Other related procedures and/or policies.
    In addition, EPA has developed an ICR to obtain the necessary
approval under the Paperwork Reduction Act (PRA) for the related
paperwork activities. The ICR document, which describes the information
collection activities and related estimated paperwork burden and costs,
will also be announced for public review and comment in a forthcoming
Federal Register document.

III. Why Hold a Workshop?

    EPA is holding this workshop to facilitate the public's comments on
the draft policies and procedures that EPA is considering for
conducting the initial screening and testing under the EDSP, as well as
the Agency's estimated burden and costs for the related paperwork
activities. The workshop is an opportunity for the public, stakeholders
and the regulated community to discuss the draft EDSP policies and
procedures and the draft ICR documents that are expected to be released
for public comment shortly. Although the workshop is not intended to
collect oral comments, the Agency intends to consider the discussion
and will be documenting the discussion for the public docket.
    In addition to attending this workshop, EPA invites you to provide
comments on the draft policies and procedures and the draft ICR for
initial EDSP screening and testing. The Federal Register documents
announcing their availability will include a specific list of questions
on which the Agency is specifically seeking comment, along with
instructions for how to submit comments on those documents. This list,
along with an agenda for the workshop, will be posted on the Agency's
website and provided at the workshop. EPA will consider all comments
received and EPA will announce the availability of the final versions
of the policies and procedures and the ICR for the initial EDSP
screening and testing in the Federal Register.

List of Subjects

    Environmental protection, Chemicals, Endocrine disruptors,
Pesticides and pests, Reporting and recordkeeping.

    Dated: November 16, 2007.
James Jones,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
[FR Doc. E7-22895 Filed 11-21-07; 8:45 am]
BILLING CODE 6560-50-S

 
 

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