

[Federal Register: January 24, 2008 (Volume 73, Number 16)]
[Notices]               
[Page 4216-4218]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ja08-82]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0012; FRL-8348-6]

 
FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a 4-day meeting of the Federal Insecticide, 
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to 
consider and review the Endocrine Disruptor Screening Program (EDSP) 
Proposed Tier-1 Screening Battery.

DATES: The meeting will be held on March 25-28, 2008, from 
approximately 8:30 a.m. to 5:00 p.m, Eastern Standard Time.
    Comments. The Agency encourages written comments be submitted by 
March 11, 2008 and requests for oral comments be submitted by March 18, 
2008. Written comments and requests to make oral comments are accepted 
until the date of the meeting but anyone submitting written comments 
after March 11, 2008 should contact the Designated Federal Official 
(DFO) listed under FOR FURTHER INFORMATION CONTACT. 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 
February 7, 2008.
    Special accommodations. For information on access or services for 
individuals with disabilities, and to request accommodation of a 
disability, please contact the 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.

ADDRESSES: The meeting will be held at the Environmental Protection 
Agency, Conference Center - Lobby Level, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, Virginia 22202.
    Comments. Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2008-0012, by one of the following methods:
      Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
      Mail: Office of Pesticide Programs (OPP) Regulatory 
Public Docket (7502P), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW, Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is (703) 305-5805.
    Instructions. Direct your comments to docket ID number EPA-HQ-OPP-
2008-0012. 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 instructions 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 
available in regulations.gov. To access the electronic docket, go to 
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket 

Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov 
website to view the docket index or access available documents. 
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 Dr., 
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 Facility telephone number is (703) 305-5805.
    Nominations: 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: Jim Downing, DFO, Office of Science 
Coordination and Policy (7201M), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(202) 564-8432; fax number: (202) 564-8382; e-mail addresses: 
downing.jim@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 particular 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

[[Page 4217]]

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?

    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-2008-0012 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 March 11, 
2008, to provide FIFRA SAP the time necessary to consider and review 
the written comments. Written comments are accepted until the date of 
the meeting but anyone submitting written comments after March 11, 2008 
should contact the DFO listed under FOR FURTHER INFORMATION CONTACT. 
Anyone submitting written comments at the meeting should bring 30 
copies for distribution to the FIFRA SAP.
    2. Oral comments. The Agency encourages that each individual or 
group wishing to make brief oral comments to FIFRA SAP submit their 
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no 
later than March 18, 2008, in order to be included on the meeting 
agenda. 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 open and 
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: Endocrinology, toxicology, aquatic 
toxicology, thyroid biology, reproductive or developmental toxicology/
endocrinology, comparative endocrinology, and toxicological pathology. 
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 February 7, 2008. 
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. Although 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 15 to 20 ad hoc scientists. FIFRA SAP members 
are subject to the provisions of 5 CFR part 2634, Executive Branch 
Financial Disclosure, as supplemented by the EPA in 5 CFR part 6401. In 
anticipation of this requirement, prospective candidates for service on 
the FIFRA SAP will be asked to submit confidential financial 
information 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 website at http://www.epa.gov/scipoly/sap or may be obtained 

from the OPP

[[Page 4218]]

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 EPA's Office of Prevention, Pesticides and Toxic 
Substances (OPPTS) 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 FIFRA 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 FQPA, 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 Scientific Advisory 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 an Endocrine Disruptor Screening Program 
(EDSP) in response to a 1996 Congressional mandate under the Federal 
Food, Drug, and Cosmetic Act (FFDCA). Section 408(p) of the FFDCA 
required the 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 other such endocrine effect as EPA may designate (FFDCA 21 
U.S.C. 346a(p). In 1998, the Endocrine Disruptor Screening and Testing 
Advisory Committee (EDSTAC), a panel of experts chartered pursuant to 
the Federal Advisory Committee Act (FACA) in response to the FFDCA, 
submitted a final report to advise the EPA on how to develop its 
Endocrine Disruptor screening and testing program. The screening 
program was also reviewed and reported on by the EPA's Science Advisory 
Board and Scientific Advisory Panel (SAB/SAP) as required by the FFDCA. 
Together, the EDSTAC and SAB/SAP recommended that the EPA address both 
human and ecological effects and examine effects on the estrogen as 
well as the androgen and thyroid (EAT) hormonal systems, and that a 
two-tiered approach be used for screening (EPA. Endocrine Disruptor 
Screening and Testing Advisory Committee EDSTAC Final Report. August 
1998.http://www.epa.gov/scipoly/oscpendo/pubs/edspoverview/ 

finalrpt.htm). The purpose of Tier-1 is to identify substances that 
have the potential to interact with the EAT hormonal systems using a 
battery of screening assays. The purpose of Tier 2 testing is to 
identify and establish a dose-response relationship for any adverse 
effects that might result from the interactions identified through the 
Tier-1 screening battery.
    The EPA has validated (or anticipates completing validation in 
2008) several candidate assays for the Tier-1 battery as follows:
     Screening assays being considered for the Tier-1 battery:
    In vitro
     Rat uterine cytosol and human recombinant estrogen 
receptor (ER) binding*
     Rat prostate cytosol androgen receptor (AR) binding
     Human cell line (H295R) steroidogenesis*
     Human placental and recombinant aromatase
    In vivo
     Uterotrophic (rat)
     Hershberger (rat)
     Pubertal female (rat)
     Pubertal male (rat)
     Adult male (rat)
     Amphibian metamorphosis (frog)
     Fish short-term reproduction
    *Consideration of these assays will be contingent on individual 
assay peer review, which is expected in 2008.
    Following an extensive validation process, the EPA has had (or 
expects to have in 2008) each of these assays peer reviewed 
independently by a panel of scientific experts. The individual assay 
peer review process was done to ensure that independent scientific 
opinions about the candidate assays were obtained and considered. 
Information regarding individual assay peer review can be found in 
section IV.D. of the Federal Register of July 13, 2007, http://www.epa.gov/fedrgstr/EPA-PEST/2007/July/Day-13/p13672.pdf
.

    The EPA is now convening an independent scientific peer review of 
the Tier-1 screening battery and has chosen the FIFRA SAP process. The 
FIFRA SAP will be charged with commenting on whether the EPA's proposed 
battery composition fulfills its purpose (i.e., to identify the 
potential to interact with the EAT hormone systems). The SAP will 
specifically be asked to comment on the strengths and limitations of 
the proposed battery, and to suggest improvements that could be made to 
the proposed battery considering candidate assays. The SAP's advice 
will inform the EPA's final decision on the composition of the EDSP's 
Tier-1 screening battery.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's background paper, related supporting 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 February 2008. 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 website or may be 
obtained from the OPP Regulatory Public Docket at http://www.regulations.gov
.


List of Subjects

    Environmental protection, pesticides and pests.

    January 17, 2008.
Elizabeth Resek,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. E8-1191 Filed 1-23-08; 8:45 am]

BILLING CODE 6560-50-S
