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FIFRA Scientific Advisory Panel; Notice of Public Meeting
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: December 8, 2004 (Volume 69, Number 235)]
[Notices]
[Page 71032-71036]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08de04-74]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0395; FRL-7688-9]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: There will be a 2-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review human health issues associated with the Cry34Ab1
protein.
DATES: The meeting will be held on March 1-2, 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
[[Page 71033]]
members of the FIFRA SAP for this meeting should be provided on or
before December 20, 2004.
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-National
Airport, 2650 Jefferson Davis Highway, Arlington,VA 22202. The
telephone number for the Holiday Inn-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-2004-0395 in
the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: Paul I. Lewis, DFO, 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:
lewis.paul@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. 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-2004-0395. 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 South 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.regulations.gov/ 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 in 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
[[Page 71034]]
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-2004-0395. 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 opp-docket@epa.gov,
Attention: Docket ID Number OPP-2004-0395. 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.
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 South Bell St., Arlington, VA, Attention: Docket ID
Number OPP-2004-0395. 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-2004-0395.
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-2004-0395 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 DFO listed under FOR FURTHER INFORMATION
CONTACT no later than noon, eastern time, February 24, 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., no later than noon, eastern time, February 24,
2005, 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.
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 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: Allergenicity, enzyme kinetics,
pepsin digestibility assays, and proteases. 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
[[Page 71035]]
FURTHER INFORMATION CONTACT on or before December 20, 2004.
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 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 FIFRA SAP will meet to consider and review human health issues
associated with the Cry34Ab1 protein. Dow AgroSciences and Pioneer Hi-
Bred International, Inc. have submitted applications for FIFRA section
3 registration of the plant-incorporated protectant (PIP) Bacillus
thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material
necessary for their production in corn. These products are intended to
provide protection against western and northern corn rootworm larvae.
Although a tolerance exemption is in place for Cry34/35, this
exemption is temporary and was granted for Experimental Use Permits
(EUPs) for Dow and Pioneer totaling 5867 acres. The Agency is still
evaluating the allergenicity potential of Cry34/35 as part of the
current request for section 3 registration. In assessing the
allergenicity potential, the Agency is using a weight of the evidence
approach that utilizes information on amino acid sequence, source of
the trait, prevalence in food, and biochemical properties of the
proteins. Cry34Ab1 and Cry35Ab1 do not have properties that would
indicate a potential for allergenicity, given the current state of
knowledge. However, Cry34Ab1 does appear to digest more slowly in
simulated gastric fluid (SGF) than other registered proteins. Moreover,
it digests faster than most allergens but slower than most previously
tested non-allergens.
As part of the registrants' request for an EUP and temporary
exemption from the requirement of a tolerance, they have submitted
several studies investigating the in vitro digestibility of the
proteins in simulated gastric fluid (SGF), which contains the enzyme
pepsin.
In the first submitted study, Cry35Ab1 was shown to digest within
1-5 minutes. Cry34Ab1 was shown to digest within 20-30 minutes. This
study, as is typical of in vitro digestibility studies for PIPs,
focused on the time required for the proteins to become undetectable,
and therefore, the results are dependent on the detection limit of the
analytical method used. Most other Cry proteins digest within 30
seconds to 5 minutes.
A second study used a kinetic approach where the rate of pepsin
digestion of Cry34Ab1 was investigated by measuring the relative amount
of Cry34Ab1 remaining at each of the time points. The registrants
estimated the half-life and DT90 (time to 90% disappearance) to be 2
minutes and 6 minutes, respectively. In this experiment, Cry34Ab1 was
undetectable after 15 to 20 minutes. Finally, the Agency has recently
received a study from the registrants that further evaluates the
kinetic method of assessing pepsin digestion using allergens and non-
allergens.
[[Page 71036]]
Kinetic approach data from studies on Cry34Ab1 and studies with
known allergens and non-allergens, as well as the Agency's
allergenicity assessment of Cry34Ab1 will be presented to the FIFRA
SAP. The Panel will be asked to consider the appropriateness of the
kinetic approach, how digestion assays should be used in allergenicity
assessments, and what assay conditions should be used for comparing the
digestion of different proteins.
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: November 30, 2004.
Joseph Merenda, Jr,
Director, Office of Science Coordination and Policy.
[FR Doc. 04-26946 Filed 12-7-04; 8:45 am]
BILLING CODE 6560-50-S