[Federal Register Volume 77, Number 65 (Wednesday, April 4, 2012)]
[Notices]
[Pages 20392-20395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8085]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2012-0230; FRL-9343-7]
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 Problem Formulation for the Reassessment of
Ecological Risks from the Use of Atrazine.
DATES: The meeting will be held on June 12-14, 2012, from 9 a.m. to
approximately 5:30 p.m. and on June 15, 2012, from 9 a.m. to
approximately 12:30 p.m.
Comments. The Agency encourages that written comments be submitted
by May 29, 2012, and requests for oral comments be submitted by June 5,
2012. However, written comments and requests to make oral comments may
be submitted until the date of the meeting, but anyone submitting
written comments after May 29, 2012, 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 April 18,
2012.
Webcast. This meeting may be webcast. Please refer to the FIFRA
SAP's Web site, http://www.epa.gov/scipoly/sap for information on how
to access the webcast. Please note that the webcast is a supplementary
public process provided only for convenience. If difficulties arise
resulting in webcasting outages, the meeting will continue as planned.
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-2012-0230, 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-
2012-0230. 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 email. The regulations.gov Web site 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 email comment directly to EPA without
going through regulations.gov, your email 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.
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: Sharlene R. Matten, Office of Science
Coordination and Policy (7201M), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-0130; fax number: (202) 564-
[[Page 20393]]
8382; email 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-2012-0230 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 May 29,
2012, 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 May 29, 2012,
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 June 5, 2012, 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: Aquatic community ecology, surface water monitoring, water
quality, environmental fate and transport, aquatic toxicity, plant
toxicity, and statistics. 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 April 18, 2012. 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 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 10-12 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
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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 Web site at http://www.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 Chemical Safety and Pollution Prevention (OCSPP) 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
In 2006, EPA initiated a program called Registration Review to re-
evaluate all pesticides on a regular cycle as part of the requirements
of the FQPA. The program reviews each pesticide active ingredient every
15 years to make sure that as the ability to assess risks to human
health and the environment evolves and as policies and practices
change, all pesticide products in the marketplace can still be used
safely. EPA will soon be reviewing atrazine as part of Registration
Review.
An important step in the development of a risk assessment is the
problem formulation. In a problem formulation, available information,
including stressor sources and characteristics, exposure, ecological
effects on plants and animals (e.g., amphibians, fish, invertebrates,
birds, and mammals), and characteristics of the ecosystem(s), is used
to define assessment endpoints and to develop a preliminary
understanding of potential risks (i.e., develop a risk hypothesis and
conceptual model) associated with the use of a pesticide. The problem
formulation also serves as an opportunity to identify missing
information/uncertainties that may limit the assessment and any
assumptions that may be made in the absence of such data. This SAP
meeting will focus on the proposed use of the Plant Assemblage Toxicity
Index (PATI)-model, amphibians, and monitoring data all which are
components of the problem formulation.
For the June 2012 SAP meeting, EPA will provide an overview of the
current state of information on atrazine use, environmental fate
(exposure), and ecological effects (toxicity) for assessing the
potential ecological risk from the use of atrazine. Emphasis of the SAP
meeting will be directed at re-evaluation of micro/mesocosm studies and
their impact on a PATI-derived level of concern (LOC) for aquatic plant
communities and a strategy for using the PATI-derived LOC for
identification of watersheds at risk. The strategy will employ
adjustments to control for bias in atrazine concentrations from
monitoring data according to sampling frequency. EPA will also include
a review of atrazine studies with amphibians published in the open
literature since the 2007 SAP on amphibians. This review will explore
whether additional effects have been associated with exposure to
atrazine and whether there is a relationship between effects reported
across various studies and common study design elements. The SAP will
be asked to comment on whether the review is thorough and whether
uncertainties have been sufficiently characterized.
The Interim Reregistration Eligibility Decision (IRED) presented
the results of the atrazine ecological risk assessment that identified
the potential for community and population risk to sensitive aquatic
species. Information in the revised IRED was based in part on the
review and recommendations of the SAP which met in June 2003 to discuss
the potential developmental effects of atrazine on amphibians. At that
meeting, the Panel concurred with EPA's analysis that there was
sufficient evidence to formulate a hypothesis that atrazine exposure
may impact gonadal development in amphibians, but there were
insufficient data at that time to confirm or refute the hypothesis.
This led EPA to seek additional data through a data call-in (DCI) to
reduce uncertainties regarding potential risk to amphibians.
In October 2007, EPA convened a second SAP meeting to evaluate
available data on atrazine effects on gonadal development in
amphibians. The SAP reviewed the document entitled ``White Paper on the
Potential for Atrazine to Affect Amphibian Gonadal Development'' and
concurred with EPA that atrazine does not consistently affect amphibian
gonadal development. Although the 2003 SAP indicated that African
clawed frog (Xenopus laevis) was an appropriate test species given the
extent to which the animal is used in amphibian developmental studies,
the 2007 Panel concluded that a major uncertainty in the registrant
data was the use of X. laevis as the test organism and the Panel
recommended that additional studies were warranted on North American
frog species. The SAP acknowledged though that there was uncertainty
whether study methods for North American species were sufficiently
developed or vetted to yield consistent results. Following the October
2007 SAP meeting, EPA determined that it was reasonable to reject the
hypothesis that atrazine exposure can affect gonadal development.
Consistent with the recommendations from the 2003 SAP, the Agency also
determined, that given the absence of consistent effects and inability
to reproduce effects used to support the hypothesis that atrazine
affects amphibian development, there was no compelling reason to pursue
additional testing with regard to the potential effects of atrazine on
amphibian gonadal development. However, the Agency acknowledged that it
would continue to monitor research on this subject as it becomes
available.
Also as a condition of the 2003 reregistration, the atrazine
registrants were required to develop a monitoring program to determine
the extent to which atrazine concentrations associated with corn,
sorghum, and sugarcane production may be exceeding levels that could
cause effects to aquatic plant communities. Forty watersheds
representing high atrazine use locations vulnerable to atrazine runoff
were selected for monitoring using a
[[Page 20395]]
stratified, random statistical survey design. Sampling within these
watersheds began in 2004 and is ongoing in selected watersheds. There
are an additional 25 sites where monitoring began in 2010 to refine the
approach for identifying vulnerable watersheds. EPA is evaluating the
results of the atrazine monitoring program, also in part, to identify
the characteristics of those watersheds that resulted in atrazine
exposures exceeding the Agency's LOC and to extrapolate those results
to other non-monitored locations to determine where atrazine
concentrations may exceed the LOC.
In December 2007, EPA presented to the SAP the use of the
Comprehensive Aquatic Systems Model (CASM) as a tool to determine an
LOC that relates time variable monitoring data to effects identified in
a series of microcosm and mesocosm studies. The SAP recommended that
EPA:
1. Work with the CASM-Atrazine model to make the population time
series more realistic;
2. Provide a better validation of this model, and
3. Conduct a more comprehensive sensitivity analysis.
In May 2009, EPA presented a simpler alternative to the CASM-based
approach to relate surface water monitoring data to the microcosm and
mesocosm data, called the PATI. Other issues presented at this meeting
included a revised assessment of the microcosm and mesocosm exposure
profiles, an update on the ecological monitoring program results,
interpretation of the monitoring results with PATI, identification of
the watershed factors driving atrazine runoff, and extrapolation of
those results to the entire atrazine use area to identify other areas
where atrazine exposures may exceed the LOC. The 2009 Panel suggested
that both the CASM-Atrazine model (presented by Syngenta) and PATI were
suitable assessment tools for atrazine. The PATI model was recommended
by the SAP as a generic assessment tool for developing an LOC, while
CASM was recommended by the SAP as a site-specific assessment tool
because of the need for extensive site-specific data. The Panel noted
that a limitation in the CASM model is the lack of understanding of the
sensitivity of model predictions with correlations among model
parameters. The SAP recommended that EPA re-evaluate the meso/microcosm
data set for study quality and concentration-specific effects, and
provided additional citations for meso/microcosm studies to consider
including in the assessment. They also recommended using a
probabilistic approach to determine the LOC. The SAP concurred with
EPA's incorporation of depth to impervious layer and slope to identify
vulnerable watersheds for atrazine runoff as part of the atrazine
vulnerability index. They also cautioned EPA that several watershed
factors such as atrazine use intensity and rainfall are temporally
dependent and, therefore, should not be considered minimum criteria in
the vulnerability index.
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 at
least 15 days prior to the meeting. 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 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: March 27, 2012.
Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. 2012-8085 Filed 4-3-12; 8:45 am]
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