[Federal Register Volume 77, Number 138 (Wednesday, July 18, 2012)]
[Pages 42307-42310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17385]



[EPA-HQ-OPP-2012-0543; FRL-9355-3]

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 the Pollinator Risk Assessment Framework.

DATES: The meeting will be held on September 11-14, 2012, from 
approximately 9 a.m. to 5:30 p.m.
    Comments. The Agency encourages that written comments be submitted 
by August 28, 2012 and requests for oral comments be submitted by 
September 4, 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 August 28, 2012 should contact the 
Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION 
CONTACT. For additional instructions, see Unit I.C. of the 
    Nominations. Nominations of candidates to serve as ad hoc members 
of FIFRA SAP for this meeting should be provided on or before August 1, 
    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.
    Submit your comments, identified by docket identification (ID) 
number EPA-HQ-OPP-2012-0543 by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.
    Nominations, requests to present oral comments, and requests for 

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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 

FOR FURTHER INFORMATION CONTACT: Fred Jenkins, DFO, Office of Science 
Coordination and Policy (7201M), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-3327; fax number: (202) 564-8382; email address: 


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-2012-0543; 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 August 
28, 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 
August 28, 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 September 4, 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: Terrestrial Community Ecology, Entomology (honeybee), 
Environmental Fate and Transport, Plant Physiology/Uptake, Residue 
Chemistry. 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 August 1, 
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 8 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

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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 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

    This U.S. Environmental Protection Agency (EPA) FIFRA Scientific 
Advisory Panel (SAP) meeting will focus on a proposed tiered process 
for quantitatively evaluating the potential risk to pollinators (using 
honeybees (Apis mellifera) as surrogate) associated with the registered 
use of both systemic and non-systemic pesticides and the exposure and 
effects data needed to support that process. During this SAP, the EPA 
will provide an overview of the proposed tiered process for quantifying 
the potential risks of pesticides to honeybees. This overview will 
reflect collective efforts with Health Canada Pest Management 
Regulatory Agency (PMRA), and California Department of Pesticide 
Regulation (CalDPR). This will include an overview of the problem 
formulation step, where protection goals are defined, along with the 
conceptual model depicting potential routes of exposure and biological 
receptors ranging from the individual bee (larvae and adult) to the 
whole colony. Consistent with the risk assessment process for other 
taxa, the proposed process will consist of a screening-level tier based 
on conservative assumptions regarding exposure and laboratory-based 
measures of effect and extending to more refined estimates of risk 
based on field-based measures of exposure and effects that are more 
reflective of how the pesticide may act under actual use conditions. 
The proposed process is intended to enhance the ability of EPA, PMRA 
and CalDPR to reliably screen chemicals for direct and indirect 
effects, specifically on managed honeybee colonies, but EPA will also 
request advice from the SAP on the usefulness of this framework for 
characterizing potential effects on other, non-Apis pollinators.A 
number of sources have reported declines in certain pollinator species 
globally. Although a number of factors/agents have been hypothesized as 
potential contributors to declines in honey bee health in general, at 
this time, no factor has been identified as the single cause. Rather, 
the available science suggests that pollinator declines are a result of 
multiple factors which may be acting in various combinations. Research 
is being directed at identifying the individual and combinations of 
stressors that are most strongly associated with pollinator declines.
    While the exact cause(s) of the general decline in pollinator 
species have not been determined, potential contributing factors 
including diseases, habitat destruction/urbanization, agricultural 
practices/monocultures, pesticides, nutrition, and bee management 
practices are among the factors being considered. Surveys of managed 
migratory bee colonies indicate that a broad range of pesticides have 
been detected in hive products (e.g., honey, stored pollen, wax). 
Typically, pesticides occur in combination with other pesticides. In 
spite of the presence of these compounds in honeybee colonies, at this 
time, based on the available research there has been no correlation 
between pollinator declines in general and the use of any pesticide or 
class of pesticides.
    Although, the role of pesticides in pollinator declines has not 
been well established, global experts from different disciplines (e.g., 
chemistry, ecotoxicology and entomologists) and across various sectors 
(e.g., government, academia and industry) agree on the need to advance 
the science to better assess potential exposure, hazard and risk to 
honey bees and other pollinators from pesticides used in agriculture. 
The proposed process which the SAP will be asked to consider reflects a 
synthesis of domestic and international efforts to develop a means for 
quantifying the potential effects of pesticides to bees.
    Consistent with the current risk assessment paradigm used by EPA, 
CalDPR, PMRA and other regulatory authorities globally, the proposed 
selection of exposure and effects data follows a tiered approach 
intended to address specific assessment endpoints of growth, survival 
and reproduction. The decision criteria for transitioning to higher 
tier testing will also be delineated. The collective aim of the SAP 
will be to delineate a process for qualitatively and quantitatively 
assessing risks to honeybees and by extension to other insect 
pollinators for which honeybees serve as surrogates. The development of 
a risk assessment process for honeybees and identification of the data 
needed to inform that process relies on a clear articulation of the 
problem formulation and risk management goals.

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 
approximately mid to late August. 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

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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: July 10, 2012.
 Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. 2012-17385 Filed 7-16-12; 8:45 am]