[Federal Register Volume 74, Number 193 (Wednesday, October 7, 2009)]
[Notices]
[Pages 51593-51596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24229]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0759; FRL-8794-7]


FIFRA Scientific Advisory Panel; Notice of Public Meeting

 AGENCY: Environmental Protection Agency (EPA).

 ACTION: Notice.

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 SUMMARY: There will be an informational meeting of the Federal 
Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel 
(FIFRA

[[Page 51594]]

SAP) to present the approach to re-evaluate atrazine.

 DATES: The meeting will be held on November 3, 2009 from approximately 
9 a.m. to 12 p.m.
    Comments. The Agency encourages that written comments be submitted 
by October 23, 2009 and requests for oral comments be submitted by 
October 27, 2009. However, written comments and requests to make oral 
comments may be submitted until the date of the meeting, but anyone 
submitting written comments after October 23, 2009 should contact the 
Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION 
CONTACT. For additional instructions, see Unit I.C. of the 
SUPPLEMENTARY INFORMATION.
    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, VA 22202.
    Comments. Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2009-0759, 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-
2009-0759. 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 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.
    Requests to present oral comments, and requests for special 
accommodations. Submit 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: [email protected].

 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-2009-0759 in the subject line 
on the first page of your request.

[[Page 51595]]

    1. Written comments. The Agency encourages that written comments be 
submitted, using the instructions in ADDRESSES, no later than October 
23, 2009, 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 
October 23, 2009 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 October 27, 2009, 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.

 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

    Atrazine is currently one of the most widely used agricultural 
pesticides in the United States, with approximately 70 million pounds 
of active ingredient applied domestically per year. First registered 
for use in December 1958, its primary uses are on corn and sugarcane, 
and to a lesser extent, on residential lawns in the Southeast. 
Consistent with the requirements of FIFRA and FFDCA, EPA and its 
predecessor agencies have required extensive evaluation of the 
potential adverse effects of atrazine over the years. Based on these 
extensive evaluations, most recently in 2003, EPA had determined that 
atrazine can be used with a reasonable certainty of no harm to human 
health if the product is used according to the label. Nonetheless, 
concerns have been raised recently about the health impacts of 
atrazine. Since 2003, there have been many studies of its ability to 
cause health effects. In order to evaluate this new science, EPA is 
launching a year long, comprehensive scientific re-evaluation of the 
potential human health impacts of atrazine by using information about 
atrazine's mode of action and by carefully considering the potential 
for cancer and non-cancer effects based on the available data from 
laboratory animal and human epidemiology studies.
    The Agency relies on transparency and sound science, including 
independent scientific peer review, to inform its regulatory decisions. 
The Agency's 2003 evaluation of atrazine provided a detailed evaluation 
of the mode of action and human health effects of atrazine. Through a 
series of SAP meetings, EPA's evaluation of the new scientific evidence 
available since that time will be described in the context of how it is 
similar to or differs from that available for the last atrazine 
assessment, and how this new evidence does or does not affect the 
Agency's human health risk assessment of atrazine.
    In the kick-off meeting to be held on November 3, 2009, the Panel 
members and public will be informed about EPA's plans for three 
subsequent SAP meetings to be held in February, April and September, 
2010.
    In February 2010 the Agency will present its proposed approach for 
incorporating epidemiology and human incident data in the risk 
assessment. It will also present its evaluations of the human 
epidemiology studies which use an ecological design that have been 
published since the last atrazine assessment. The SAP will be asked to 
comment on the soundness of the scientific approach.
    At the April 2010 meeting, EPA will present its evaluation of non-
cancer effects based on an evaluation of studies used in past 
assessments, as well as those that have been published since then. The 
Agency will also present new data on alternative modes of action not 
considered in the 2003 evaluation as well as EPA's plans for sampling 
frequency and monitoring of community water systems. The SAP will be 
asked to comment about the soundness of the scientific approach.
    In September 2010, EPA will discuss its evaluation of cancer 
effects, based on an evaluation of studies used in past assessments, as 
well as those that have been published since then, including new 
findings from the Agricultural Health Study anticipated in 2010. EPA 
will also present any changes to its plans for monitoring community 
water systems based on its analysis and the SAP's guidance from the 
April meeting. Further, any new scientific developments related to the 
Agency's evaluation of non-cancer effects or setting the FQPA safety 
factor which may have become available since the April meeting will 
also be presented. The SAP will be asked to comment about the soundness 
of the scientific approach.
    At the end of this year-long effort, the Agency will determine if 
the current risk assessment for atrazine should be revised and whether 
or not the Agency's current regulatory position and community water 
system monitoring requirements should be changed.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's background paper, related supporting materials, FIFRA SAP 
panel members, and the meeting agenda will be available by mid-October 
for the November 3, 2009 meeting. In addition, the Agency may provide 
additional background documents as the materials become available. You 
may obtain electronic copies of these documents,

[[Page 51596]]

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: September 30, 2009.
Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. E9-24229 Filed 10-6-09; 8:45 am]
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