[Federal Register Volume 69, Number 235 (Wednesday, December 8, 2004)]
[Notices]
[Pages 71032-71036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26946]


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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: 
<a href="/cdn-cgi/l/email-protection#4d21283a243e633d2c38210d283d2c632a223b"><span class="__cf_email__" data-cfemail="fd91988a948ed38d9c8891bd988d9cd39a928b">[email protected]</span></a>.

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 <greek-i>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.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 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 <a href="/cdn-cgi/l/email-protection#c1aeb1b1eca5aea2aaa4b581a4b1a0efa6aeb7"><span class="__cf_email__" data-cfemail="4d223d3d6029222e2628390d283d2c632a223b">[email protected]</span></a>, 
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 
<greek-i>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


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