[Federal Register Volume 76, Number 88 (Friday, May 6, 2011)]
[Pages 26287-26290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-11027]



 [EPA-HQ-OPP-2011-0399; FRL- 8872-8]

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 Non-Cancer 
Effects, Drinking Water Monitoring Frequency, and Cancer Epidemiology.

DATES: The meeting will be held on July 26-29, 2011, from approximately 
8:30 a.m. to 5 p.m.
    Comments. The Agency encourages that written comments be submitted 
by July 12, 2011 and requests for oral comments be submitted by July 
19, 2011. However, written comments and requests to make oral comments 
may be submitted until the date of the meeting, but anyone submitting 
written comments after July 12, 2011 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 May 20, 
    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-2011-0399, 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-
2011-0399. 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 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 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.
    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: Joseph 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].


[[Page 26288]]

 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-2011-0399 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 July 12, 
2011, 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 July 12, 
2011should contact the DFO listed under FOR FURTHER INFORMATION 
CONTACT. Anyone submitting written comments at the meeting should bring 
30 copies for distribution to the FIFRA SAP.
    2. Oral comments. The Agency encourages that each individual or 
group wishing to make brief oral comments to the FIFRA SAP submit their 
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no 
later than July 19, 2011, 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, environmental epidemiology, exposure assessment 
(particularly pesticide applicators), mammary gland development, mode 
of action analysis (particularly those with MOA framework experience), 
frameworks to evaluate human relevance, prostate development, 
pharmacokinetics, physiologically-based pharmacokinetic modeling, 
neuroendocrinology, hormone-mediated health effects, HPA axis 
(corticosterone), 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 May 20, 2011. 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 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 candidate's financial disclosure

[[Page 26289]]

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 Web site 
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 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

    EPA is undertaking a re-evaluation of the human health effects of 
atrazine. The human health re-evaluation has involved three SAP 
meetings in 2010 and one in 2011. The first meeting was held in 
February 2010 during which 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 
second meeting in April 2010 SAP meeting focused on:
    1. A preliminary review of experimental toxicology studies from 
laboratory mammals and in vitro studies and recent advancements in 
understanding atrazine's mode of action along with;
    2. Statistical and modeling approaches for evaluating monitoring 
frequency in community water systems (CWS). The September 2010 meeting 
built on the scientific analysis and SAP feedback from the April 
meeting. Specifically, the Agency presented scientific analyses on an 
empirical approach for estimating internal dosimetry, and calculation 
of benchmark dose estimates for purposes of deriving points of 
departure. In addition, EPA presented a general strategy for designing 
a monitoring study to characterize drinking water exposures and 
discussed different methods for analyzing and interpreting monitoring 
data collected at different sampling frequencies. The September 2010 
meeting also provided proposals for updating the critical durations of 
exposure based on the new science, and a preliminary evaluation of 
potential susceptibility of the young. In addition, the September 2010 
meeting included evaluation of non-cancer epidemiology studies, a 
weight of the evidence evaluation of the non-cancer epidemiology 
studies with experimental laboratory studies, and a proposal to use the 
non-cancer epidemiology studies qualitatively in evaluating the human 
relevance of experimental toxicology findings.
    The July 2011 SAP meeting will build on the scientific analyses and 
SAP feedback from the previous three SAP meetings by proposing a 
conceptual framework for the evaluation of atrazine human health non-
cancer effects. This proposed conceptual framework will integrate 
information on mode of action and adverse outcome pathways, potentially 
susceptible lifestages/subpopulations, drinking water exposure, 
internal dosimetry, and water monitoring sampling uncertainty. The 
Agency will solicit comment on the overall integrative approach 
proposed for atrazine along with technical considerations for each 
scientific component. To illustrate the conceptual framework, a case 
study will be provided that demonstrates an approach for estimating 
non-cancer risk to atrazine based on an internal dose metric for 
temporally, spatially, and demographically explicit information. The 
Agency will use feedback received from the SAP at the July 2011 meeting 
as it completes the scientific analysis for determining whether or not 
adjustments may be necessary in the sampling frequency of CWS 
monitoring. The evaluation of non-cancer effects will include studies 
available up through April 29, 2010.
    In the 2003 Interim Reregistration Eligibility Decision (IRED) for 
atrazine, the Agency noted that it would convene another SAP meeting 
concerning atrazine and its possible association with carcinogenic 
effects, particularly as new information from the National Cancer 
Institute's (NCI) Agricultural Health Study (AHS) is made available. 
The Agency believes it is appropriate at this time to re-evaluate the 
cancer epidemiology literature on atrazine in a SAP meeting; EPA notes 
that the evidence of atrazine carcinogenicity based upon experimental 
animal data were evaluated by the SAP in April 2010. As such, at the 
July 2011 meeting, the Agency will provide a preliminary review of 
cancer epidemiology studies and a draft weight of the evidence (WOE) 
analysis on cancer that integrates mode of action, experimental 
toxicology information, and epidemiology. This draft WOE analysis will 
follow the Draft Framework for Incorporating Epidemiologic and Human 
Incident Data in Health Risk Assessment, which was reviewed by the SAP 
in February 2010. The Agency will include epidemiological studies on 
the cancer effects of atrazine available up through April 29, 2010. The 
Agricultural Health Study is anticipated to be published in spring 2011 
and will be part of this review given that this study is considered to 
be a pivotal line of evidence.
    At the February 2010 SAP, the Agency presented a proposed plan for 
a collaborative project with investigators from the AHS to evaluate 
approaches for estimating exposure to pesticide applicators. At the 
July 2011 meeting, the Agency will discuss the status of the 
collaborative project (which includes a case study involving atrazine) 
and solicit comment from the Panel on the overall direction of the 
project and the methods development aspects of this effort. This 
project is part of a larger effort by OPP to improve the incorporation 
of epidemiology in human health risk assessment. The feedback from the 
SAP may not be used for atrazine risk assessment per se but

[[Page 26290]]

will inform EPA's continued efforts to improve risk assessment 
approaches and methodologies.

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 
late June. 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: April 27, 2011.
 Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. 2011-11027 Filed 5-5-11; 8:45 am]