```

[Federal Register: March 5, 2010 (Volume 75, Number 43)]
[Notices]               
[Page 10255-10258]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr10-67]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0125; FRL-8812-2]

 
FIFRA Scientific Advisory Panel; Notice of Public Meeting

 AGENCY: Environmental Protection Agency (EPA).

 ACTION: Notice.

-----------------------------------------------------------------------

 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 a set of scientific issues related to the Re-
Evaluation of Human Health Effects of Atrazine: Review of Experimental 
Animal and In Vitro Studies and Drinking Water Monitoring Frequency.

 DATES:  The meeting will be held on April 26-29, 2010, and will begin 
on Monday, April 26, 2010 at 1 p.m. On April 27-29, 2010, the meeting 
will be held from approximately 8:30 a.m. to 5 p.m.
    Comments. The Agency encourages that written comments be submitted 
by April 12, 2010 and requests for oral comments be submitted by April 
19, 2010. However, written comments and requests to make oral comments 
may be submitted until the date of the meeting, but anyone submitting 
written comments after April 12, 2010 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 FIFRA SAP for this meeting should be provided on or before March 19, 
2010.
    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 Hamilton Crowne Plaza 
Hotel, located at 1001 14th St., NW., Washington, DC, 20005. 
The telephone number for the Hamilton Crowne Plaza Hotel is (202) 682-
0111.
    Comments. Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2010-0125; 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 Facility'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-
2010-0125. 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

[[Page 10256]]

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, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either 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, requests to present oral comments, and requests for 
special accommodations. Submit nominations to serve as ad hoc members 
of 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:  Joseph E. Bailey, DFO, Office of 
Science Coordination and Policy (7201M), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; 
telephone number: (202) 564-2045; fax number: (202) 564-8382; e-mail 
address: bailey.joseph@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?

    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-2010-0125; 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 April 12, 
2010, 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 April 12, 
2010 should contact the DFO listed under FOR FURTHER INFORMATION 
CONTACT. Anyone submitting written comments at the meeting should bring 
30 copies for distribution to 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 April 19, 2010, 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 
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 FIFRA SAP 
for this meeting. As part of a broader process for developing a pool of 
candidates for each meeting, FIFRA SAP staff routinely solicits the 
stakeholder community for nominations of prospective candidates for 
service as ad hoc members of 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: Risk assessment, mode of action analysis (particularly those 
with MOA framework experience), frameworks to evaluate human relevance, 
pharmacokinetics, neuroendocrinology (hormone-mediated health effects), 
HPA axis (corticosterone), immuno- toxicology, epidemiology, 
reproductive/developmental biology and environmental sampling and 
statistical modeling. 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 March 
19, 2010. 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 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

[[Page 10257]]

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 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 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 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://epa.gov/scipoly/sap 
or may be obtained from the OPP Regulatory Public Docket at http://www.regulations.gov.

II. Background

A. Purpose of FIFRA SAP

    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. FIFRA SAP is a Federal advisory committee established in 
1975 under FIFRA that operates in accordance with requirements of the 
Federal Advisory Committee Act. 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 SAP on an ad hoc basis to assist in reviews 
conducted by the SAP. As a peer review mechanism, FIFRA SAP provides 
comments, evaluations and recommendations to improve the effectiveness 
and quality of analyses made by Agency scientists. Members of FIFRA SAP 
are scientists who have sufficient professional qualifications, 
including training and experience, to provide expert advice and 
recommendation to the Agency.

 B. Public Meeting

    EPA is undertaking a re-evaluation of the human health effects of 
atrazine. The re-evaluation plan was presented to the FIFRA Scientific 
Advisory Panel (SAP) in November 2009 and involves three SAP meetings 
in 2010. The first was held in February 2010 where the Agency presented 
its preliminary reviews of several atrazine epidemiology studies on 
birth outcomes and described a project plan to evaluate atrazine 
epidemiology data from the Agricultural Health Study (http://aghealth.nci.nih.gov/). The April 2010 SAP meeting will focus on:
    1. A preliminary review of mammalian in vivo as well as in vitro 
studies on toxicological effects and modes of action.
    2. Statistical approaches for evaluating monitoring frequency in 
community water systems (CWS).
     For the April SAP meeting, the Agency's scientific review of 
toxicology studies will focus on those studies used to support the 
reregistration of atrazine and new studies available up to January 30, 
2010. Any studies that become available after January 30, 2010 will be 
integrated into the Agency's weight-of-the-evidence (WOE) analysis 
scheduled for review by the FIFRA SAP in September 2010. This WOE 
analysis will integrate in vivo and in vitro laboratory studies along 
with epidemiologic data and other human information.
     At the April meeting, the Agency plans to solicit comment from the 
SAP on the toxicological importance and human relevance of a variety of 
effects including findings on the hypothalamic-pituitary-adrenal (HPA) 
axis, immune system, prostate, brain, and the enzyme, aromatase. In 
addition, the Agency plans to discuss the scientific issues associated 
with lifestage susceptibility and linking a chemically-induced 
activation of the HPA axis to other health outcomes and possible 
approaches to use key events in a mode of action in risk assessment. 
The Agency will not be proposing updated points of departure or a 
complete scientific analysis relevant to the FQPA Safety Factor for 
protection of infants and children at the April SAP meeting. The Agency 
will consider the advice of the April SAP, however, to help inform 
these issues which will be presented to the September SAP. Following 
the April SAP, the Agency will continue to review the scientific 
literature with particular emphasis on the potential for differential 
lifestage susceptibility and the temporal aspects of pharmacokinetic 
and pharmacodynamic events. This temporality is an important scientific 
issue for the assessment of the health effects of atrazine because the 
duration of exposure leading to adverse effects is a critical aspect of 
determining the appropriate frequency of water monitoring in CWS, which 
will also, be discussed in September.
     As a condition of reregistration of atrazine, EPA required the 
registrants to implement a monitoring program in selected CWS, 
generally in the corn and sorghum growing area of the midwest. In 
implementing a monitoring program, the frequency of sampling is closely 
linked to the health effects of concern. If the health effects of 
concern relate to long-term chronic exposures, a yearly average 
concentration is sufficient. Less frequent sampling may provide 
sufficient data for EPA to be reasonably confident that the results are 
representative of a yearly average concentration. However, for effects 
that can occur after shorter exposure durations, more frequent sampling 
may be needed in order to be confident that the sampling has not missed 
a high-end or peak exposure that could significantly affect the 
estimate of short term exposure. The Agency will be

[[Page 10258]]

evaluating the temporality of toxic effects as it conducts this 
reevaluation of atrazine and at the April SAP will also discuss 
proposed statistical approaches to determine the appropriate monitoring 
frequency for different durations of interest.
     The Agency will consider the advice and recommendations received 
from the SAP at the April 2010 meeting as it develops the WOE analysis 
integrating experimental toxicology and epidemiology studies with 
statistical analysis for determining the frequency of water monitoring 
scheduled for review by the SAP in September.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's background paper, related supporting materials, charge/
questions to FIFRA SAP, FIFRA SAP composition (i.e., members and ad hoc 
members for this meeting), and the meeting agenda will be available by 
mid-March. 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.
    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.

    Dated: February 17, 2010.
 Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. 2010-4540 Filed 3-4-10; 8:45 a.m.]
BILLING CODE 6560-50-S
```