

[Federal Register: December 13, 2006 (Volume 71, Number 239)]
[Notices]               
[Page 74901-74904]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13de06-35]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0987; FRL-8107-9]

 
FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY: There will be a 2-day meeting of the Federal Insecticide, 
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to 
consider and review the status of the in utero through lactational 
assay in the Endocrine Disruptor Screening Program (EDSP).

DATES: The meeting will be held on February 27-28, 2007, from 8:30 a.m. 
to 5 p.m, eastern time.
    Comments: The Agency encourages submission of written comments by 
February 13, 2007 and requests for oral comments by February 20, 2007. 
However, written comments and requests to make oral comments may be 
submitted until the date of the meeting. For additional instructions, 
see Unit I.C. of the SUPPLEMENTARY INFORMATION.
    Nominations: Nominations of candidates to serve as ad hoc members 
of the FIFRA SAP for this meeting should be provided on or before 
December 26, 2006.
    Special Accommodations: For information on access or services for 
individuals with disabilities, and to request accommodation of a 
disability, please contact the Designated Federal Official (DFO) 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.

[[Page 74902]]


ADDRESSES: The meeting will be held at the Environmental Protection 
Agency, Conference Center - Lobby Level, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Drive, Arlington, VA 22202.
    Comments: Submit your comments, identified by docket ID number EPA-
HQ-OPP-2006-0987, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments. Your use of 
the Federal eRulemaking Portal to submit comments to EPA electronically 
is EPA's preferred method for receiving comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., N.W., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0987. If your comments contain any information that you consider 
to be CBI or otherwise protected, please contact the DFO listed under 
FOR FURTHER INFORMATION CONTACT to obtain special instruction before 
submitting your comments. 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 website 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 a docket index 
that is available at http://www.regulations.gov. Although listed in a 

docket 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, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 

copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg), 2777 S. Crystal Drive, Arlington, VA. The hours of 
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The Docket telephone number 
is (703) 305-5805.
    Nominations, requests to present oral comments, and requests for 
special accommodations: Submit nominations to serve as an ad hoc member 
of the FIFRA SAP, requests for special seating accommodations, or 
requests to present oral comments to the DFO listed under FOR FURTHER 
INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: William Wooge, DFO, Office of Science 
Coordination and Policy (7201M), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202-
564-8476; fax number: 202-564-8382; e-mail addresses: 
wooge.william@epa.gov.


SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may, 
however, be of interest to persons who are or may be required to 
conduct testing of chemical substances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), FIFRA, and the Food Quality Protection Act of 
1996 (FQPA). Since other entities may also be interested, the Agency 
has not attempted to describe all the specific entities that may be 
affected by this action. If you have any questions regarding the 
applicability of this action to a particular entity, consult the DFO 
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

     Tips for preparing your comments. When submitting comments, 
remember to:
    1. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
     2. 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.
    3. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information 
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    6. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline 
identified.

C. How May I Participate in this Meeting?

    You may participate in this meeting by following the instructions 
in this unit. To ensure proper receipt by EPA, it is imperative that 
you identify docket ID number EPA-HQ-OPP-2006-0987 in the subject line 
on the first page of your request.
    1. Written comments. The Agency encourages that written comments be 
submitted, using the instructions in ADDRESSES, no later than February 
13, 2007, to provide FIFRA SAP the time necessary to consider and 
review the written comments. However, written comments are accepted 
until the date of the meeting. Persons wishing to submit written 
comments at the meeting should contact the DFO listed under FOR FURTHER 
INFORMATION CONTACT and submit 30 copies. There is no limit on the 
extent of written comments for consideration by FIFRA SAP.
    2. Oral comments. The Agency encourages that each individual or 
group wishing to make brief oral comments to the FIFRA SAP submit their 
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no 
later than February 20, 2007, in order to be included on the meeting 
agenda.

[[Page 74903]]

Requests to present oral comments will be accepted until the date of 
the meeting and, to the extent that time permits, the Chair of the 
FIFRA SAP may permit the presentation of oral comments at the meeting 
by interested persons who have not previously requested time. The 
request should identify the name of the individual making the 
presentation, the organization (if any) the individual will represent, 
and any requirements for audiovisual equipment (e.g., overhead 
projector, 35 mm projector, chalkboard). Oral comments before FIFRA SAP 
are limited to approximately 5 minutes unless prior arrangements have 
been made. In addition, each speaker should bring 30 copies of his or 
her comments and presentation slides for distribution to the FIFRA SAP 
at the meeting.
    3. Seating at the meeting. Seating at the meeting will be on a 
first-come basis.
    4. Request for nominations to serve as ad hoc members of the FIFRA 
SAP for this meeting. As part of a broader process for developing a 
pool of candidates for each meeting, the FIFRA SAP staff routinely 
solicits the stakeholder community for nominations of prospective 
candidates for service as ad hoc members of the FIFRA SAP. Any 
interested person or organization may nominate qualified individuals to 
be considered as prospective candidates for a specific meeting. 
Individuals nominated for this meeting should have expertise in one or 
more of the following areas: Mammalian (rat) reproductive endocrinology 
and developmental and reproductive toxicology. Nominees should be 
scientists who have sufficient professional qualifications, including 
training and experience, to be capable of providing expert comments on 
the scientific issues for this meeting. Nominees should be identified 
by name, occupation, position, address, and telephone number. 
Nominations should be provided to the DFO listed under FOR FURTHER 
INFORMATION CONTACT on or before December 26, 2006. The Agency will 
consider all nominations of prospective candidates for this meeting 
that are received on or before this date. However, final selection of 
ad hoc members for this meeting is a discretionary function of the 
Agency.
     The selection of scientists to serve on the FIFRA SAP is based on 
the function of the panel and the expertise needed to address the 
Agency's charge to the panel. No interested scientists shall be 
ineligible to serve by reason of their membership on any other advisory 
committee to a Federal department or agency or their employment by a 
Federal department or agency except the EPA. Other factors considered 
during the selection process include availability of the potential 
panel member to fully participate in the panel's reviews, absence of 
any conflicts of interest or appearance of lack of impartiality, 
independence with respect to the matters under review, and lack of 
bias. Though financial conflicts of interest, the appearance of lack of 
impartiality, lack of independence, and bias may result in 
disqualification, the absence of such concerns does not assure that a 
candidate will be selected to serve on the FIFRA SAP. Numerous 
qualified candidates are identified for each panel. Therefore, 
selection decisions involve carefully weighing a number of factors 
including the candidates' areas of expertise and professional 
qualifications and achieving an overall balance of different scientific 
perspectives on the panel. In order to have the collective breadth of 
experience needed to address the Agency's charge for this meeting, the 
Agency anticipates selecting approximately 10 ad hoc scientists. If a 
prospective candidate for service on the FIFRA SAP is considered for 
participation in a particular session, the candidate is subject to the 
provisions of 5 CFR part 2634, Executive Branch Financial Disclosure, 
as supplemented by the EPA in 5 CFR part 6401. As such, the FIFRA SAP 
candidate is required to submit a Confidential Financial Disclosure 
Form for Special Government Employees Serving on Federal Advisory 
Committees at the U.S. Environmental Protection Agency (EPA Form 3110-
48 [5-02]) which shall fully disclose, among other financial interests, 
the candidate's employment, stocks and, bonds, and where applicable, 
sources of research support. The EPA will evaluate the candidates 
financial disclosure form to assess whether there are financial 
conflicts of interest, appearance of a lack of impartiality or any 
prior involvement with the development of the documents under 
consideration (including previous scientific peer review) before the 
candidate is considered further for service on the FIFRA SAP. Those who 
are selected from the pool of prospective candidates will be asked to 
attend the public meetings and to participate in the discussion of key 
issues and assumptions at these meetings. In addition, they will be 
asked to review and to help finalize the meeting minutes. The list of 
FIFRA SAP members participating at this meeting will be posted on the 
FIFRA SAP web site at http://epa.gov/scipoly/sap or may be obtained from the OPP Regulatory Public Docket at http://www.regulations.gov.


II. Background

A. Purpose of the FIFRA SAP

     The FIFRA SAP serves as the primary scientific peer review 
mechanism of the United States Environmental Protection Agency (EPA), 
Office of Prevention, Pesticides and Toxic Substances and is structured 
to provide scientific advice, information and recommendations to the 
EPA Administrator on pesticides and pesticide-related issues as to the 
impact of regulatory actions on health and the environment. The FIFRA 
SAP is a Federal advisory committee established in 1975 under the 
Federal Insecticide, Fungicide and Rodenticide Act that operates in 
accordance with requirements of the Federal Advisory Committee Act. The 
FIFRA SAP is composed of a permanent panel consisting of seven members 
who are appointed by the EPA Administrator from nominees provided by 
the National Institutes of Health and the National Science Foundation. 
FIFRA, as amended by the 1996 Food Quality Protection Act, established 
a Science Review Board consisting of at least 60 scientists who are 
available to the Scientific Advisory Panel on an ad hoc basis to assist 
in reviews conducted by the Panel. As a peer review mechanism, the 
FIFRA SAP provides comments, evaluations and recommendations to improve 
the effectiveness and quality of analyses made by Agency scientists. 
Members of the FIFRA SAP are scientists who have sufficient 
professional qualifications, including training and experience, to 
provide expert advice and recommendations to the Agency.

B. Public Meeting

    The EPA is implementing the Endocrine Disruptor Screening Program 
(EDSP) in response to a 1996 Congressional mandate in the Federal Food, 
Drug, and Cosmetic Act (FFDCA) to establish a screening program using 
validated assays to identify pesticides that may have estrogenic 
effects in humans and other endocrine effects, as designated by the EPA 
Administrator. The Agency also has authority to include other non-
pesticide chemicals that have an effect cumulative to that of a 
pesticide to which a substantial human population may be exposed. In 
developing the EDSP, the EPA considered the recommendations of the 
Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), 
a panel chartered pursuant to the Federal Advisory Committee Act

[[Page 74904]]

(FACA). The screening program was also reviewed by EPA's Science 
Advisory Board and by the Scientific Advisory Panel (SAB/SAP), as 
required by the FFDCA. It was recommended that the EPA address both 
human and ecological effects and examine effects to estrogen, androgen, 
and thyroid (EAT) related processes, and that a two-tiered approach be 
used for screening. The purpose of the Tier-1 battery is to identify 
substances that have the potential to interact with the endocrine 
system. The purpose of Tier 2 is to confirm the interaction, identify 
any adverse effects, and establish quantitative relationships between 
dose and adverse effects.
    Both the EDSTAC and SAB/SAP recognized the importance of chemical 
exposure during development in utero as well as during lactation and, 
therefore, recommended an in utero through lactational animal model to 
detect effects that may result from pre- and postnatal exposure. The 
EDSTAC and SAB/SAP also recommended that any in utero through 
lactational bioassay should be developed in a way that would allow for 
replacement of one or more of the other assays proposed for the Tier-1 
screening battery.
    The EDSP commissioned an in utero through lactational Detailed 
Review Paper (DRP) that consisted of an extensive review of the 
scientific literature regarding chemicals known to disrupt the EAT 
hormone systems during pre- and postnatal development. The DRP 
presented three in utero through lactational bioassay protocols for the 
EDSP to consider. The EPA presented the DRP and its recommendations to 
the Endocrine Disruptor Methods Validation Subcommittee (EDMVS) for 
review and discussion. The most comprehensive of the three protocols 
was chosen and tested with methoxychlor, a positive compound that is 
known to have estrogenic, anti-estrogenic and anti-androgenic effects. 
In general, the EDMVS agreed with this pre-validation approach with the 
expectation that the EPA would return to a federal advisory committee 
such as the SAP to review and discuss the results of the in utero 
through lactational study with methoxychlor.
    The purpose of this meeting is to allow the SAP to review and 
discuss the protocol and assay results of an in utero through 
lactational study with methoxychlor within the current context of the 
EDSP and to provide advice that will inform the EPA's decision to 
continue, modify or suspend the development of an in utero through 
lactational bioassay as a screening assay in a Tier-1 battery.

C. FIFRA SAP Documents and Meeting Minutes.

    EPA's background materials, charge/questions to the FIFRA SAP, 
FIFRA SAP composition (i.e., members and ad hoc members for this 
meeting), and the meeting agenda will be available by late January 
2007. In addition, the Agency may provide additional background 
documents as the materials become available. You may obtain electronic 
copies of these documents, and certain other related documents that 
might be available electronically, at http://www.regulations.gov and the FIFRA SAP homepage at http://www.epa.gov/scipoly/sap.

    The FIFRA SAP will prepare meeting minutes summarizing its 
recommendations to the Agency approximately 90 days after the meeting. 
The meeting minutes will be posted on the FIFRA SAP web site or may be 
obtained from the OPP Regulatory Public Docket at http://www.regulations.gov
.


List of Subjects

    Environmental protection, Pesticides and pests.


    Dated: December 7, 2006.
Elizabeth A. Resek,
Director, Office of Science Coordination and Policy.
[FR Doc. E6-21201 Filed 12-12-06; 8:45 am]

BILLING CODE 6560-50-S
