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: June 13, 2001 (Volume 66, Number 114)]
[Notices]
[Page 31915-31916]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jn01-60]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00724; FRL-6787-6]
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 (FIFRA) and Food Quality Protection Act
(FQPA) Scientific Advisory Panel (SAP) to review a set of issues being
considered by the Agency pertaining to an assessment of additional
scientific information concerning StarLinkTM corn. Members
of the public may submit written comments for consideration by the SAP.
In addition, EPA will provide an opportunity during the public meeting
for the public to make brief oral remarks to the SAP. The procedures
governing submission of written comments and the presentation of oral
comments are described below. Seating at the meeting will be on a
first-come basis. Individuals requiring special accommodations at this
meeting, including wheelchair access, should contact Paul Lewis at the
address listed under FOR FURTHER INFORMATION CONTACT at least 5
business days prior to the meeting so that appropriate arrangements can
be made.
DATES: The meeting will be held on July 17 and July 18 from
approximately 8:30 a.m. to 5 p.m.
ADDRESSES: The meeting will be held at the Sheraton Crystal City Hotel,
1800 Jefferson Davis Highway, Arlington, VA 22202. The telephone number
for the Sheraton Crystal City Hotel is (703) 486-1111.
Requests to participate 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, your request must identify docket control number
OPP-00724 in the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: Paul Lewis, Designated Federal
Official, Office of Science Coordination and Policy (7202C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 305-5369; fax number:
(703) 605-0656; e-mail address: 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) and 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 under FOR FURTHER INFORMATION CONTACT.
[[Page 31916]]
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. A meeting agenda and several background
documents relevant to this meeting are now available. EPA's primary
position, paper, and questions to the FIFRA SAP should be available as
soon as possible, but no later than late June. In addition, the Agency
expects to provide additional background documents as the material
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. To access this document on the Home Page
select Federal Register notice announcing this meeting. 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 meeting under docket control number OPP-00724. The official record
consists of the documents specifically referenced in this notice, any
public comments received during an applicable comment period, and other
material information, 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. In addition, the Agency may
provide additional background documents as the material becomes
available. The public version of the official record, which includes
printed, paper versions of any electronic comments that may be
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 Hwy.,
Arlington, VA 22202, 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 Can I Request to Participate in this Meeting?
You may submit a request to participate in this meeting through the
mail, in person, or electronically. Do not submit any information in
your request that is considered CBI. To ensure proper receipt by EPA,
it is imperative that you identify docket control number OPP-00724 in
the subject line on the first page of your request. Interested persons
are permitted to file written statements before the meeting. To the
extent that time permits, and upon advance written request to the
person listed under FOR FURTHER INFORMATION CONTACT, interested persons
may be permitted by the Chair of the FIFRA SAP to present oral
statements at the meeting. 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).
There is no limit on the extent of written comments for consideration
by the Panel, but oral statements before the Panel are limited to
approximately 5 minutes. The Agency also urges the public to submit
written comments in lieu of oral presentations. Persons wishing to make
oral and/or written statements at the meeting should contact the person
listed under FOR FURTHER INFORMATION CONTACT and submit 30 copies of
their presentation and/or remarks to the panel. The Agency encourages
that written statements be submitted before the meeting to provide
panel members the time necessary to consider and review the comments.
1. By mail. You may submit a request to: Public Information and
Records Integrity Branch (PIRIB), Information Resources and Services
Division (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
2. In person or by courier. 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 Hwy., Arlington,
VA 22202. 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 request electronically by e-
mail to: ``opp-docket@epa.gov.'' Do not submit any information
electronically that you consider to be CBI. Use WordPerfect 6.1/8.0 or
ASCII file format and avoid the use of special characters and any form
of encryption. Be sure to identify by docket control number OPP-00724.
You may also file a request online at many Federal Depository
Libraries.
II. Background
A. Purpose of the Meeting
On November 28, 2000, the FIFRA SAP met to review the potential
allergenicity, sensitization, and dietary exposure to
StarLinkTM corn. The Panel concluded that based on the
available information at that time, there was a medium likelihood that
the Cry9C protein was a potential allergen. However, the Panel also
concluded that ``while not conclusive, the likely levels of the Cry9C
protein in the U.S. diet provide sufficient evidence of a low
probability of allergenicity in the exposed population.'' The Panel
recommended that certain additional information would be valuable to
refining the risk assessment. The Panel recommended that the highest
priority was for follow-up on those individuals who had claimed that
they had suffered some type of allergic reaction after eating a corn
product that might have contained StarLinkTM corn and to
determine if there were antibodies for Cry9C in the blood serum of
these individuals.
The SAP also recommended collecting additional information to
improve the estimate of the levels of Cry9C protein in the food supply.
The SAP will be meeting to assess additional scientific information
concerning StarLinkTM corn. The SAP will review EPA's paper
on the possible presence of Cry9C protein in processed human foods from
wet milling of corn, the work the United States Department of
Agriculture and Aventis Crop Sciences have done to reduce the amount of
StarLinkTM corn going into the food supply, the scientific
data in Aventis Crop Sciences petition for a tolerance for Cry9C
protein of 20 parts per billion in corn grain, validation of new
detection methods for Cry9C protein in finished foods, and the Food and
Drug Administration and Centers for Disease Control and Prevention's
efforts to develop a test method for blood serum from individuals who
reported having allergic type responses after eating foods containing
corn.
B. Panel Report
The Panel will prepare a report of its recommendations to the
Agency. The report 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. of this document.
List of Subjects
Environmental protection.
Dated: June 4, 2001.
Vanessa Vu,
Director, Office of Science Coordination and Policy.
[FR Doc. 01-14905 Filed 6-12-01; 8:45 am]
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