[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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