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Allergenicity Assessment of Cry9C BT Corn Plant Pesticide
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: December 21, 1999 (Volume 64, Number 244)]
[Notices]
[Page 71452-71453]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21de99-74]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-867A; FRL-6098-2]
Allergenicity Assessment of Cry9C BT Corn Plant Pesticide
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Agency is soliciting input on the assessment of the
potential for allergenicity of non-digestible proteins expressed as
plant-pesticides. The specific case in question concerns the Cry9C
insecticidal protein derived from Bacillus thuringiensis and expressed
in field corn. In addition to EPA data evaluation records, the Agency
is asking for comment on questions within an EPA background document
regarding the use of amino acid homology, the brown Norway rat model,
and other items regarding the assessment for potential allergenicity.
This issue will also be one of the subjects of a FIFRA Science Advisory
Panel (SAP) meeting in early February, 2000.
DATES: Comments, identified by docket control number PF-867A, must be
received on or before February 22, 2000. The actual meeting date and
other details will be announced in a subsequent Federal Register
publication.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I. of the ``SUPPLEMENTARY INFORMATION.'' To ensure
proper receipt by EPA, it is imperative that you identify docket
control number PF-867A in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: John Kough or Mike Mendelsohn, OPP/
BPPD (751lC), Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460; telephone number: (703) 308 8267 or (703) 308-
8715; tax number: (703) 308-7026; e-mail address: kough.john@epa.gov or
mendelsohn.mike @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 those persons who are technical experts in
human allergenicity or those persons who may be required to conduct
testing to assess the potential for the allergenicity of non-digestible
proteins expressed as plant-pesticides under the Federal Food, Drug and
Cosmetic Act (FFDCA), or the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). 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 person
listed in the ``FOR FURTHER INFORMATION CONTACT'' section.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents (including copies of
EPA's data evaluation records, and the list of questions regarding
allergenicity) that might be available electronically, from the EPA's
Biopesticide Internet Home Page at http:/ /www.epa.gov/pesticides/
biopesticides. To access this document, on the Home Page select ``Laws
and Regulations'' and then look up the entry for this document under
the ``Federal Register--Environmental Documents.'' You can also go
directly to the Federal Register listings at http://www.epa.gov/
fedrgstr.
2. In person. The Agency has established an official record for
this action under docket control number PF-867A. The official record
consists of the documents specifically referenced in this action
(including copies of EPA's health effects reviews, the list of selected
technical experts that comprise the technical peer review committee,
and the list of questions regarding allergenicity), any public comments
received during an applicable comment period, and other information
related to this action, including any information claimed as
confidential business information (CBI). This official record includes
the documents that are physically located in the docket, as well as the
documents that are referenced in those documents. The public version of
the official record does not include any information claimed as CBI.
The public version of the official record, which includes printed,
paper versions of any electronic comments submitted during an
applicable comment period, is available for inspection in the Public
Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall
#2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The PIRIB
telephone number is (703) 305-5805.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number PF-867A in the subject line on the
first page of your response.
1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460.
2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.
3. Electronically. You may submit your comments electronically by
E-mail to: ``opp-docket@epa.gov,'' or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in WordPerfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be
identified by docket control number PF-867A. Electronic comments may
also be filed online at many Federal Depository Libraries.
D. How Should I Handle CBI that I Want to Submit to the Agency?
Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record.
[[Page 71453]]
Information not marked confidential will be included in the public
version of the official record without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person identified in the ``FOR FURTHER INFORMATION CONTACT''
section.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
\ Explain your views as clearly as possible.
\ Describe any assumptions that you used.
\ Provide copies of any technical information and/or data you used
that support your views.
\ If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
\ Provide specific examples to illustrate your concerns.
\ Offer alternative ways to improve the rule or collection
activity.
\ Make sure to submit your comments by the deadline in this notice.
\ To ensure proper receipt by EPA, be sure to identify the docket
control 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.
II. Background
A. What Action is the Agency Taking?
On April 7, 1999, EPA announced the receipt of a pesticide petition
(PP 9F5050) (64 FR 16965) (FRL-6069-8) from AgrEvo USA Company. The
petition, 9F5050, proposed an amendment to 40 CFR 180.1192 to expand
the current exemption from the requirement of a tolerance for Bacillus
thuringiensis subspecies tolworthi Cry9C protein and the genetic
material necessary for its production in corn from corn used for feed
only (and associated residues in meat, poultry, milk, or eggs resulting
from animals fed such feed) to all food commodities. EPA has completed
it's initial review of the data submitted in support of this petition
and is and is soliciting public comment on the data evaluation records,
and a list of questions regarding human allergenicity assessment for
non-digestible proteins expressed as plant-pesticides. This issue will
also be one of the subjects of a FIFRA Science Advisory Panel (SAP)
meeting in early February 2000.
B. What is the Agency's Authority for Taking this Action?
The Agency is soliciting input to aid in determining whether there
is a reasonable certainty of no harm for the proposed expansion of the
exemption from the requirement of a tolerance under the Federal Food,
Drug and Cosmetic Act (FFDCA).
List of Subjects
Environmental protection, Pesticides and pests.
Dated: December 9, 1999.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. 99-32871 Filed 12-17-99; 9:17 am]
BILLING CODE 6560-50-F