[Federal Register Volume 77, Number 65 (Wednesday, April 4, 2012)]
[Pages 20392-20395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8085]



[EPA-HQ-OPP-2012-0230; FRL-9343-7]

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 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 
    Nominations. Nominations of candidates to serve as ad hoc members 
of FIFRA SAP for this meeting should be provided on or before April 18, 
    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 
    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 

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: matten.sharlene@epa.gov.


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 

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 
    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 

 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 
    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 
    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 
    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 
    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]