

[Federal Register: October 27, 2006 (Volume 71, Number 208)]
[Notices]               
[Page 63007-63010]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27oc06-53]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0856; FRL-8099-8]

 
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 Worker Exposure Assessment Methods.

DATES: The meeting will be held on January 9-12, 2007, from 8:30 a.m. 
to 5 p.m, eastern time.
     Comments: Written comments and requests to make oral comments are 
accepted until the date of the meeting. However, the Agency encourages 
the submission of written comments by December 26, 2006, and requests 
to present oral comments by January 2, 2007. For additional 
instructions, see Unit I.C. of the SUPPLEMENTARY INFORMATION.
     Nominations: Nominations of candidates to serve as ad hoc members 
of the FIFRA SAP for this meeting should be provided on or before 
November 8, 2006.
     Special Accommodations: For information on access or services for 
individuals with disabilities, and to request accommodation of a 
disability, please contact the Designated Federal Official (DFO) listed 
under For Further Information Contact at least 10 days prior to the 
meeting to give EPA as

[[Page 63008]]

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 ID number 
EPA-HQ-OPP-2006-0856, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments. Your use of 
the Federal eRulemaking Portal to submit comments to EPA electronically 
is EPA's preferred method for receiving 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 Drive, Arlington, VA. Deliveries are only 
accepted during the Docket'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 telephone number is (703) 305-5805.
     Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0856. 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 instruction 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 a docket index 
that is available at http://www.regulations.gov. Although listed in a 

docket 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 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 telephone number 
is (703) 305-5805.
     Nominations, requests to present oral comments, and requests for 
special accommodations: Submit nominations to serve as an ad hoc member 
of the 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:  Myrta R. Christian, DFO, Office of 
Science Coordination and Policy (7201M), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone 
number: (202) 564-8498; fax number: (202) 564-8382; e-mail address: 
christian.myrta@epa.gov.


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?

    1. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information subject heading, Federal Register date and page number.
    ii. 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.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. 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-2006-0856 in the subject line 
on the first page of your request.
    1. Written comments. Although, submission of written comments are 
accepted until the date of the meeting, unless otherwise stated, the 
Agency encourages that written comments be submitted, using the 
instructions in ADDRESSES, by December 26, 2006, to provide FIFRA SAP 
the time necessary to consider and review the written comments. There 
is no limit on the extent of written comments for consideration by 
FIFRA SAP. Persons wishing to submit written comments at the meeting 
should contact the DFO listed under FOR FURTHER INFORMATION CONTACT and 
submit 30 copies.
    2. Oral comments. Although, requests to present oral comments are 
accepted until the date of the meeting, unless otherwise stated, to the 
extent that time

[[Page 63009]]

permits, the Chair of the FIFRA SAP may permit the presentation of oral 
comments at the meeting by interested persons who have not previously 
requested time. However, each individual or group wishing to make brief 
oral comments to FIFRA SAP is encouraged to submit their request to the 
DFO listed under FOR FURTHER INFORMATION CONTACT by January 2, 2007, in 
order to be included on the meeting agenda. 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 FIFRA SAP at the meeting.
    3. Seating at the meeting. Seating at the meeting will be on a 
first-come basis.
    4. Request for nominations to serve as ad hoc members of the FIFRA 
SAP for this meeting. As part of a broader process for developing a 
pool of candidates for each meeting, the FIFRA SAP staff routinely 
solicits the stakeholder community for nominations of prospective 
candidates for service as ad hoc members of the 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: Exposure assessment, statistics, 
biological monitoring, pharmacokinetics, and agricultural engineering. 
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 November 8, 2006. 
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 the 
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. Though 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 the 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 12 ad hoc scientists.
     If a prospective candidate for service on the FIFRA SAP is 
considered for participation in a particular session, the candidate is 
subject to the provisions of 5 CFR part 2634, Executive Branch 
Financial Disclosure, as supplemented by the EPA in 5 CFR part 6401. As 
such, the FIFRA SAP candidate is required to submit a Confidential 
Financial Disclosure Form for Special Government Employees Serving on 
Federal Advisory Committees at the U.S. Environmental Protection Agency 
(EPA Form 3110-48 [5-02]) 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 that there are no 
financial conflicts of interest, no appearance of lack of impartiality 
and no prior involvement with the development of the documents under 
consideration (including previous scientific peer review) before the 
candidate is considered further for service on the 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 the FIFRA SAP

     The FIFRA SAP serves as the primary scientific peer review 
mechanism of the United States Environmental Protection Agency (EPA), 
Office of Prevention, Pesticides and Toxic Substances 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. The FIFRA 
SAP is a Federal advisory committee established in 1975 under the 
Federal Insecticide, Fungicide and Rodenticide Act and operates in 
accordance with requirements of the Federal Advisory Committee Act. The 
SAP is composed of a permanent panel consisting of seven members, 
appointed by the EPA Administrator from nominees provided by the 
National Institutes of Health and the National Science Foundation. 
FIFRA, as amended by the 1996 Food Quality Protection Act, 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 Panel. As a peer review mechanism, the FIFRA SAP provides 
comments, evaluations and recommendations to improve the effectiveness 
and quality of scientific analyses made by Agency scientists. Members 
of the 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

    The Agency issued its first occupational exposure testing 
guidelines in the early 1980s. These guidelines were intended to 
standardize the methodology used to conduct the studies necessary to 
allow the Agency to determine the potential exposures, and consequently 
risks, associated with the activities surrounding the use of 
pesticides. These activities included handling pesticides (i.e., 
mixing, loading and applying) as well as working in treated sites 
following pesticide applications (e.g., harvesting, thinning, weeding, 
servicing cooling towers). In the early 1990s, two databases--the 
Pesticide Handlers

[[Page 63010]]

Exposure Database (PHED) and the Chemical Manufacturers Association 
(CMA) data--were constructed in order to estimate exposures resulting 
from mixing/loading/applying pesticides. The data assembled for use in 
these databases were taken from published literature as well as from 
industry studies submitted to the Agency. These databases have been 
used as the main sources for estimating occupational exposures to 
workers handling pesticides for both registration and reregistration 
actions. Since the early 1980s, the Agency has been using a scenario-
based approach in its assessments for estimating exposures for 
occupational pesticide handlers (e.g., mixers, loaders, and 
applicators). This approach is consistent with the Agency's guidelines 
for exposure assessment which can be found on the EPA website at http://cfpub.epa.gov/ncea
[fxsp0]/cfm/recordisplay.cfm?deid=15263.

    Over the years since the issuance of the exposure guidelines, there 
have been scientific issues raised about the accuracy of exposure 
estimates based on data developed using these methods. In addition, 
recent protocols for the generation of new agricultural pesticide 
handler exposure data are being generated by a pesticide industry task 
force and were reviewed by the Agency's Human Subjects Review Board 
(HSRB) (see http://www.epa.gov/osa/hsrb/files/[fxsp0
]june2006finaldraftreport82806.pdf for further information). The 

board raised questions concerning the scientific merits of the proposed 
protocols.
    Given the scientific issues that have been raised regarding 
occupational pesticide exposure estimates and study protocols, 
including the recent comments from the HSRB, at this time EPA is asking 
the FIFRA Scientific Advisory Panel (SAP) to evaluate, in detail, 
issues associated with certain methodologies used to generate exposure 
studies and the procedures used to develop exposure estimates. As part 
of the background for the SAP meeting, the Agency is developing a case 
study that details the procedures and data the Agency uses to evaluate 
6 exposure scenarios that are common in agriculture. These data can be 
found in the existing Pesticide Handlers Exposure Database.
    The following four issues are expected to be the focus of this SAP 
review: Sample collection methods (e.g., whole-body dosimetry, 
handwashing, facial/neck wipes, and biological monitoring); data needs 
(e.g., availability of data in the Pesticide Handlers Exposure 
Database); unit exposure (e.g., relating the amount of exposure to the 
amount of chemical active ingredient handled); and sample size issues 
(e.g., inter-/intra-worker variability and representativeness).

C. FIFRA SAP Documents and Meeting Minutes

     EPA's position paper, charge/questions to the FIFRA SAP, FIFRA SAP 
composition i.e., members and ad hoc members for this meeting, and the 
meeting agenda will be available by mid December 2006. 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.

    The 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: October 19, 2006.
Clifford Gabriel,
Director, Office of Science Coordination and Policy.
[FR Doc. E6-18036 Filed 10-26-06; 8:45 am]

BILLING CODE 6560-50-S
