[Federal Register Volume 64, Number 244 (Tuesday, December 21, 1999)]
[Notices]
[Pages 71452-71453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32871]


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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: [email protected] 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: ``[email protected],'' 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