[Federal Register Volume 70, Number 4 (Thursday, January 6, 2005)]
[Notices]
[Pages 1239-1243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-263]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0405; FRL-7692-2]


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 a set of four major issues associated with the N-
methyl carbamate pesticide cumulative risk assessment: pilot cumulative 
analysis. On February 15-16, 2005, the FIFRA SAP will meet to review 
issues associated with hazard assessment and pharmacokinetic/
pharmacodynamic modeling; and on February 17-18, 2005, to review ground 
water models and drinking water exposure assessment and the integration 
of hazard and exposure information.

DATES: The meeting will be held on February 15-18, 2005, from 8:30 a.m. 
to approximately 5 p.m., eastern time.
    Comments: For the deadlines for the submission of requests to 
present oral comments and the submission of written comments, see Unit 
I.E. of the SUPPLEMENTARY INFORMATION.
    Nominations: Nominations of scientific experts to serve as ad hoc 
members of the FIFRA SAP for this meeting should be provided on or 
before January 18, 2005.
    Special seating. Requests for special seating arrangements should 
be made at least 5 business days prior to the meeting.

ADDRESSES: The meeting will be held at the Holiday Inn, Reagan National 
Airport, 2650 Jefferson Davis Highway, Arlington, VA 22202. The 
telephone number for the Holiday Inn - Reagan National Airport is (703) 
684-7200.
    Comments. Written comments may be submitted electronically 
(preferred), through hand delivery/courier, or by mail. Follow the 
detailed instructions as provided in Unit I. of the SUPPLEMENTARY 
INFORMATION.
    Nominations, requests to present oral comments, and special 
seating. To submit nominations for ad hoc members of the FIFRA SAP for 
this meeting, requests for special seating arrangements, or requests to 
present oral comments, notify the Designated Federal Official (DFO) 
listed under FOR FURTHER INFORMATION CONTACT. To ensure proper receipt 
by EPA, your request must identify docket ID number OPP-2004-0405 in 
the subject line on the first page of your request.

FOR FURTHER INFORMATION CONTACT: Myrta R. Christian for the hazard 
assessment and pharmacokinetic/pharmocodynamic modeling sessions and 
Joseph E. Bailey for the drinking water exposure assessment and the 
integration of hazard and exposure assessment sessions. DFOs, Office of 
Science Coordination and Policy (7201M), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone 
number: (202) 564-8450; fax number: (202) 564-8382; e-mail addresses: 
[email protected] or [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 DFOs 
listed under FOR FURTHER INFORMATION CONTACT.

[[Page 1240]]

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2004-0405. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although, a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket telephone number is (703) 305-
5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    EPA's position paper, charge/questions to FIFRA SAP, FIFRA SAP 
composition (i.e., members and consultants for this meeting) and the 
meeting agenda will be available as soon as possible, but no later than 
(early February 2005). 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, from the FIFRA SAP 
Internet Home Page at http://www.epa.gov/scipoly/sap.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Once in the system, select ``search,'' 
then key in the appropriate docket ID number.
    Certain types of information will not be placed in EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although, not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B.1. EPA intends to work 
towards providing electronic access to all of the publicly available 
docket materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or on paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments in hard copy that are mailed or delivered to 
the docket will be scanned and placed in EPA's electronic public 
docket. Where practical, physical objects will be photographed, and the 
photograph will be placed in EPA's electronic public docket along with 
a brief description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically (preferred), through hand 
delivery/courier, or by mail. To ensure proper receipt by EPA, identify 
the appropriate docket ID number in the subject line on the first page 
of your comment. Please ensure that your comments are submitted within 
the specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. Do not use EPA Dockets or e-mail to submit CBI or 
information protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also, include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. 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.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2004-0405. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID number OPP-2004-0405. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you deliver as described in Unit I.C.2 or mail to the address 
provided in Unit I.C.3. These electronic submissions will be accepted 
in WordPerfect or ASCII file format. Avoid the use of special 
characters and any form of encryption.

[[Page 1241]]

    2. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
number OPP-2004-0405. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.
    3. By mail. Due to potential delays in EPA's receipt and processing 
of mail, respondents are strongly encouraged to submit comments either 
electronically or by hand delivery or courier. We cannot guarantee that 
comments sent via mail will be received prior to the close of the 
comment period. If mailed, please send your comments to: Public 
Information and Records Integrity Branch (PIRIB) (7502C), Office of 
Pesticide Programs (OPP), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: Docket ID 
number OPP-2004-0405.

D. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. Provide specific examples to illustrate your concerns.
    5. Make sure to submit your comments by the deadline in this 
document.
    6. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

E. 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 OPP-2004-0405 in the subject line on the 
first page of your request.
    1. Oral comments. Oral comments presented at the meetings should 
not be repetitive of previously submitted oral or written comments. 
Although, requests to present oral comments are accepted until the date 
of the meeting (unless otherwise stated), to the extent that time 
permits, interested persons may be permitted by the Chair of FIFRA SAP 
to present oral comments at the meeting. Each individual or group 
wishing to make brief oral comments to FIFRA SAP is strongly advised to 
submit their request to the appropriate DFO listed under FOR FURTHER 
INFORMATION CONTACT no later than noon, eastern time, February 8, 2005, 
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.
    2. 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 Unit I.C., no later than noon, eastern time, February 
1, 2005, to provide FIFRA SAP the time necessary to consider and review 
the written comments. The DFOs listed under FOR FURTHER INFORMATION 
CONTACT should be notified that comments have been submitted to the 
docket or a courtesy copy of the comments should be provided to the 
DFOs. There is no limit on the extent of written comments for 
consideration by FIFRA SAP.
    3. Seating at the meeting. Seating at the meeting will be on a 
first-come basis. Individuals requiring special accommodations at this 
meeting, including wheelchair access and assistance for the hearing 
impaired, should contact the appropriate DFO at least 5 business days 
prior to the meeting using the information under FOR FURTHER 
INFORMATION CONTACT so that appropriate arrangements can be made.
    4. Request for nominations of prospective candidates for service 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 solicit 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: Pharmacokinetic/pharmacodynamic 
modeling, toxicology and risk assessment, hazard assessment, exposure 
assessment (particularly drinking water), ground water modeling/
monitoring and integration of hazard and exposure. 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 appropriate DFO listed under FOR 
FURTHER INFORMATION CONTACTon or before January 18, 2005. 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

[[Page 1242]]

Financial Disclosure, as supplemented by 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 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. EPA will evaluate the candidate's 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 or may be obtained by 
contacting the PIRIB at the address or telephone number listed in Unit 
I.

II. Background

A. Purpose of the FIFRA SAP

    Amendments to FIFRA enacted November 28, 1975 (7 U.S.C. 136w(d)), 
include a requirement under section 25(d) of FIFRA that notices of 
intent to cancel or reclassify pesticide registrations pursuant to 
section 6(b)(2) of FIFRA, as well as proposed and final forms of 
regulations pursuant to section 25(a) of FIFRA, be submitted to a SAP 
prior to being made public or issued to a registrant. In accordance 
with section 25(d) of FIFRA, the FIFRA SAP is to have an opportunity to 
comment on the health and environmental impact of such actions. The 
FIFRA SAP also, shall make comments, evaluations, and recommendations 
for operating guidelines to improve the effectiveness and quality of 
analyses made by Agency scientists. Members are scientists who have 
sufficient professional qualifications, including training and 
experience, to be capable of providing expert comments as to the impact 
on health and the environment of regulatory actions under sections 6(b) 
and 25(a) of FIFRA. The Deputy Administrator appoints seven individuals 
to serve on the FIFRA SAP for staggered terms of 4 years, based on 
recommendations from the National Institutes of Health and the National 
Science Foundation.
    Section 104 of FQPA (Public Law 104-170) established the FQPA 
Science Review Board (SRB). These scientists shall be available to the 
FIFRA SAP on an ad hoc basis to assist in reviews conducted by the 
FIFRA SAP.

B. Public Meeting

    The Food, Quality Protection Act of 1996 amended the Federal 
Insecticide, Fugicide, and Rodenticide Act and the Federal Food, Drug, 
and Cosmetic Act. One of the major changes is the requirement that EPA 
consider risk posed by pesticides acting by a common mechanism of 
toxicity. For such groups of pesticides, EPA's Office of Pesticide 
Programs (OPP) has treated cumulative risk, under FQPA, as the risk of 
a common toxic effect associated with concurrent exposure by all 
relevant pathways and routes. EPA has determined that the group of 
pesticides known as the N-methyl carbamate pesticide share a common 
mechanism of toxicity, and should be treated as a common mechanism 
group. Therefore, EPA is conducting a cumulative risk assessment that 
will include the chemicals comprising this group.
    At the meeting being announced by this notice, EPA plans to discuss 
key issues related to development of the cumulative risk assessment for 
the N-methyl carbamate pesticides. Those issues are as follows: Hazard 
assessment, pharmacokinetic/pharmacodynamic (PBPK/PD) modeling of 
carbaryl, drinking water exposure assessment, and the integration of 
hazard and exposure information.

C. Hazard assessment

    EPA acknowledges that there are toxicological characteristics 
unique to the N-methyl carbamates which need to be considered in a 
cumulative risk assessment for this group. Specifically, the mechanism 
of action for this group of pesticides is carbamylation of the 
acetylcholinesterase (AChE) active site. This chemical change is 
reversible, allowing for relatively rapid recovery from inhibition. OPP 
is collaborating with laboratory scientists and statisticians from 
EPA's National Health and Environmental Effects Research Laboratory 
(NHEERL) to evaluate biological and empirical aspects of recovery. EPA 
expects to solicit comment from the SAP on specific issues related to 
dose-response modeling of AChE data, empirical estimation of time to 
recovery, and the impact of the laboratory method used to measure AChE 
inhibition on estimates of relative potency.
    1. PBPK/PD modeling for carbaryl. OPP is collaborating with 
scientists from EPA's National Exposure Research Laboratory (NERL) to 
develop a PBPK/PD model for carbaryl within the Exposure Related Dose 
Estimating Model (ERDEM) Platform (Blancato et al., 2002; Okino et al. 
2004). The carbaryl model will form the basic structure of a 
generalized model for the N-methyl carbamates. A Quantitative Structure 
Activity Relationship (QSAR) database of physicochemical descriptors 
and provisional PK and PD parameter values has been assembled for 
selected N-methyl carbamates. The completeness and representativeness 
of the QSAR database will influence the application of the PBPK/PD 
model for use in the cumulative risk assessment of the N-methyl 
carbamates. EPA will solicit comment from the SAP on specific aspects 
of the appropriate use of ERDEM for this cumulative risk assessment.
    2. Drinking water exposure assessment. Unlike the organophosphate 
(OP) cumulative risk assessment where the only anticipated exposure to 
OP pesticides in drinking water was expected to be from surface water 
sources, EPA must consider both surface water and ground water sources 
of drinking water for the N-methyl carbamates. OPP will solicit comment 
from the SAP on the use of one or more existing ground water models to 
provide a pilot drinking water exposure assessment for the N-methyl 
carbamates. OPP also expects to request feedback from the Panel on 
approaches for refining regional drinking water exposures in the event 
that such exposure from surface water and/or ground water sources 
contributes substantially to the cumulative exposure in one or more 
regions.
    3. Integration of hazard and exposure assessment. EPA will present 
to the SAP a pilot cumulative analysis of food, water, and residential 
exposure using three different exposure models: LifeLine, CARES, and 
Calendex. The presentation will also include a discussion of the unique 
challenges related to rapid recovery from AChE inhibition posed by this 
group of pesticides and different approaches for considering these 
characteristics in the quantitative estimates of cumulative risk. EPA 
expects to request the panel to provide comment on potential approaches 
for integrating hazard and exposure for this group and specifically 
characterizing recovery in risk estimates.

[[Page 1243]]

C. FIFRA SAP Meeting Minutes

    The FIFRA SAP will prepare meeting minutes summarizing its 
recommendations to the Agency in approximately 60 days after the 
meeting. The meeting minutes will be posted on the FIFRA SAP web site 
or may be obtained by contacting the PIRIB at the address or telephone 
number listed in Unit I.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: December 28, 2004.
Joseph J. Merenda, Jr.,
Director, Office of Science Coordination and Policy.
[FR Doc. 05-263 Filed 1-5-05; 8:45 am]
BILLING CODE 6560-50-S