EPA Draft White Paper Regarding StarLink®, 58978-58980 [E7-20381]
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58978
Federal Register / Vol. 72, No. 200 / Wednesday, October 17, 2007 / Notices
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2007–0832; FRL–8145–7]
EPA Draft White Paper Regarding
StarLink Corn Dietary Exposure and
Risk; Availability for Comment
Environmental Protection
Agency (EPA).
ACTION: Notice.
mstockstill on PROD1PC66 with NOTICES2
AGENCY:
SUMMARY: EPA is seeking comment on a
draft White Paper that reviews data on
the level in the human food supply of
Cry9C protein from StarLink corn
grain. It concludes that the protein has
been sufficiently removed from the
human food supply to render the level
of risk low enough that continued
testing for the protein in yellow corn at
dry mills and masa production facilities
provides no added public health
protection. The White Paper therefore
recommends that the Food and Drug
Administration (FDA) withdraw its
guidance recommending testing yellow
corn grain for Cry9C at dry mills and
masa production facilities. Concurrent
with this notice, the FDA is publishing
for comment a notice in the Federal
Register that FDA is considering
withdrawing its guidance.
DATES: Comments must be received on
or before December 3, 2007.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2007–0832, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPP–2007–
0832. EPA’s policy is that all comments
received will be included in the docket
without change and may be made
available on-line at https://
www.regulations.gov, including any
personal information provided, unless
VerDate Aug<31>2005
19:12 Oct 16, 2007
Jkt 214001
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or email. The regulations.gov website is an
‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through
regulations.gov, your e-mail address
will be automatically captured and
included as part of the comment that is
placed in the docket and made available
on the Internet. If you submit an
electronic comment, EPA recommends
that you include your name and other
contact information in the body of your
comment and with any disk or CD-ROM
you submit. 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. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket
are listed in the docket index available
in regulations.gov. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either in the
electronic docket at https://
www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket
Facility are from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The Docket Facility telephone
number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Mike Mendelsohn, Biopesticides and
Pollution Prevention Division (7511P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
PO 00000
Frm 00002
Fmt 4701
Sfmt 4703
DC 20460–0001; telephone number:
(703) 308–8715; fax number: (703) 308–
7026; e-mail address:
mendelsohn.mike@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are anagricultural
producer or food manufacturer.
Potentially affected entities may
include, but are not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. What Should I Consider as I Prepare
My Comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or e-mail. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD-ROM that
you mail to EPA, mark the outside of the
disk or CD-ROM as CBI and then
identify electronically within the disk or
CD-ROM the specific information that is
claimed as CBI. In addition to one
complete version of the comment that
includes 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 docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
E:\FR\FM\17OCN2.SGM
17OCN2
Federal Register / Vol. 72, No. 200 / Wednesday, October 17, 2007 / Notices
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns and suggest
alternatives.
vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
II. Background
mstockstill on PROD1PC66 with NOTICES2
What Action is the Agency Taking?
EPA is seeking comment on a draft
White Paper that reviews data on the
level in the human food supply of
Cry9C protein from StarLink corn
grain. It concludes that the protein has
been sufficiently removed from the
human food supply to render the level
of risk low enough that continued
testing for the protein in yellow corn at
dry mills and masa production facilities
provides no added public health
protection. StarLink refers to a variety
of corn genetically engineered to
express the protein Cry9C. Because
Cry9C is toxic to various insect pests of
corn, Cry9C acts as a pesticide and was
regulated by the U.S. Environmental
Protection Agency (EPA or Agency)
under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA)
and the Federal Food, Drug, and
Cosmetic Act (FFDCA). Under FIFRA
and FFDCA, a company seeking to sell
or distribute a pesticide must submit
data demonstrating that it will not cause
unreasonable adverse effects on the
environment and that any residues in
food will be safe, i.e., there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.
Aventis Agroscience, Inc. (Aventis)
submitted data on the safety of
StarLink and applied for approvals
under FIFRA and FFDCA. EPA
concluded that the available data did
not provide enough information to
support a conclusion that Cry9C was not
a potential human allergen, but that all
other information indicated that it
would not pose any other types of risks
VerDate Aug<31>2005
19:12 Oct 16, 2007
Jkt 214001
to human health or the environment.
Accordingly, in 1998 EPA registered
StarLink for commercial use, provided
that all grain derived from StarLink
corn was directed to domestic animal
feed or to industrial uses (e.g., biofuels).
The intent of requiring all StarLink to
be segregated as either animal feed or
for industrial use was to preclude any
occurrence of the potentially allergenic
Cry9C in human food. The registration
contained several specific requirements
designed to ensure that no StarLink
grain entered the human food supply.
Following registration, relatively small
quantities of StarLink were planted in
the United States: 9,018 acres in 1998,
247,694 acres in 1999, and 350,000
acres in 2000, with the largest planting
representing less than half a percent of
the total acreage planted to corn in the
United States.
In September 2000, residues from
StarLink were detected in taco shells,
indicating that it had entered the human
food supply. In response to these
detections, Aventis requested
cancellation of the StarLink
registration, https://www.epa.gov/
fedrgstr/EPA-PEST/2001/January/Day18/p1522.htm. In addition, working
with U.S. Department of Agriculture
(USDA), Food and Drug Administration
(FDA), EPA, and the food industry,
Aventis undertook a program to remove
all StarLink from the food supply.
Among other measures, FDA
recommended that facilities engaged in
the dry milling or masa production of
yellow corn test all incoming shipments
of yellow corn for the possible presence
of Cry9C and that they divert all
shipments testing positive to domestic
feed or industrial use.
At the same time, Aventis also
requested that EPA reconsider its
position that the available data did not
provide enough information to support
a conclusion that Cry9C was not a
potential human allergen. Aventis
provided additional data and analysis to
support its position that the allergenic
risks of Cry9C were very small. Most of
the arguments advanced by Aventis
involved the assertion that exposure to
Cry9C was so low, especially after the
full implementation of the containment
and removal program, that there would
be no threat to public health. In 2000
and 2001 EPA held a series of meetings
of its FIFRA Scientific Advisory Panel
(SAP or Panel) to evaluate the scientific
issues raised by the new data, analysis,
and arguments.
Following the cancellation of the
StarLink registration, Aventis
established a separate corporate entity,
StarLink Logistics Inc. (SLLI), as the
successor to Aventis’ interest in
PO 00000
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Fmt 4701
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58979
StarLink products. SLLI oversees the
StarLink. Enhanced Stewardship
Program, through which SLLI and the
U.S. corn millers have continued the
efforts to contain and remove Cry9C
from the human food supply. SLLI also
maintains a monitoring database
containing the test results from more
than 4 million tests from over 4 billion
bushels of corn collected by dry milling
facilities and other corn handling
operations. These tests were carried out
according to guidance developed by
FDA and USDA’s Grain Inspection,
Packers and Stockyards Administration
(GIPSA), and the federal government
considers the data reliable.
In 2005, SLLI commissioned
Exponent, Inc., to prepare a new
exposure assessment of the levels of
Cry9C present in the U.S. food supply
for submission to EPA. SLLI provided
supplemental information in 2006 that
updates the 2005 exposure assessment
and that quantitatively characterizes the
impact of the monitoring and diversion
program on exposure to Cry9C. The
USDA’s Agricultural Research Service
(ARS) provided the analytical data on
Cry9C concentrations in corn grain used
in Exponent’s exposure analysis. In
addition, the ARS provided results from
testing corn seeds from the 1970s and
1980s (that is, before Cry9C was ever
bioengineered into corn) for the possible
presence of naturally occurring Cry9C or
other proteins that give a positive
reaction in the Cry9C test. GIPSA
conducted additional testing to verify
the results of the ARS laboratory.
The draft EPA White Paper concludes
that the protein has been sufficiently
removed from the human food supply to
render the level of risk low enough that
continued testing for the protein in
yellow corn at dry mills and masa
production facilities provides no added
public health protection. The White
Paper therefore recommends that FDA
withdraw its guidance recommending
testing yellow corn grain for Cry9C at
dry mills and masa production facilities.
A full copy of the draft EPA White
Paper is available in the docket and at
https://www.epa.gov/pesticides/
biopesticides/pips/star-link-whitepaper.pdf.
List of Subjects
Environmental protection,
Agricultural commodities, Pesticides
and pests.
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58980
Federal Register / Vol. 72, No. 200 / Wednesday, October 17, 2007 / Notices
Dated: October 3, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention,
Pesticides and Toxic Substances.
[FR Doc. E7–20381 Filed 10–16–07; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001D–0025 (formerly Docket
No. 01D–0025)]
Guidance for Industry on FDA
Recommendations for Sampling and
Testing Yellow Corn and Dry-Milled
Yellow Corn Shipments Intended for
Human Food Use for Cry9C Protein
Residues; Comments on Possible
Withdrawal
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
mstockstill on PROD1PC66 with NOTICES2
SUMMARY: The Food and Drug
Administration (FDA) is seeking
comment on whether to withdraw its
guidance document entitled ‘‘FDA
Recommendations for Sampling and
Testing Yellow Corn and Dry-Milled
Yellow Corn Shipments Intended for
Human Food Use for Cry9C Protein
Residues.’’ FDA is considering
withdrawing its guidance in response to
the release by the Environmental
Protection Agency (EPA) of a draft
‘‘White Paper Concerning Dietary
Exposure to Cry9C Protein Produced by
STARLINK Corn and the Potential Risks
Associated with Such Exposure,’’ the
availability of which is announced
elsewhere in this issue of the Federal
Register.
DATES: Submit written or electronic
comments by December 17, 2007.
ADDRESSES: Submit written comments
on this notice to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Lauren Posnick Robin or Samir Assar,
Center for Food Safety and Applied
Nutrition (HFS–300), Food and Drug
Administration, 5100 Paint Branch
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19:12 Oct 16, 2007
Jkt 214001
Pkwy., College Park, MD 20740, 301–
436–1639 or 301–436–1636,
respectively.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 22,
2001 (66 FR 6627), FDA issued final
guidance for industry entitled ‘‘FDA
Recommendations for Sampling and
Testing Yellow Corn and Dry-Milled
Yellow Corn Shipments Intended for
Human Food Use for Cry9C Protein
Residues.’’ Cry9C is a pesticidal protein
in the STARLINK variety of yellow corn
that makes the corn more resistant to
certain types of insects. EPA authorized
STARLINK corn only for use in animal
feed. EPA did not authorize the use of
STARLINK corn in human food because
of unresolved questions about the
allergenic potential of the Cry9C
protein. Although restricted to animal
food use, some STARLINK corn was
commingled with yellow corn intended
for human use. In addition, in certain
limited cases, the Cry9C protein was
also detected in corn seeds of a nonSTARLINK variety of corn or in corn
from such seeds. In response to these
findings, Aventis S.A. (the developer of
STARLINK corn), EPA, FDA, the United
States Department of Agriculture, and
the food industry undertook efforts
starting in 2000 to remove all
STARLINK corn from the food supply.
Among other measures, FDA issued
guidance recommending that corn drymilling and masa operations screen
yellow corn (and milled yellow corn in
certain situations) to minimize the
production of human food products
with corn containing the Cry9C protein.
Corn containing the Cry9C pesticide is
adulterated under section 402(a)(2)(B) of
the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 342(a)(2)(B)) if
such corn is for human food use because
there is no tolerance or exemption from
the need for a tolerance under section
408 of the act (21 U.S.C. 346a).
Therefore, FDA recommended that
manufacturers who detected Cry9Ccontaining corn in any lot should divert
the lot to animal feed or industrial use.
EPA has developed a draft ‘‘White
Paper Concerning Dietary Exposure to
Cry9C Protein Produced by STARLINK
Corn and the Potential Risks Associated
with Such Exposure’’ (draft White
PO 00000
Frm 00004
Fmt 4701
Sfmt 4703
Paper), which it is making available for
comment elsewhere in this issue of the
Federal Register. In the draft White
Paper, EPA concludes that the Cry9C
protein has been sufficiently removed
from the human food supply to render
the level of risk low enough that
continued testing for the protein in
yellow corn at dry mills and masa
production facilities provides no
additional human health protection.
EPA reached that conclusion based on
information including results from more
than 4 million tests for Cry9C at corn
handling operations over the past 7
years and an exposure assessment by
Exponent, Inc., of the levels of Cry9C
still present in the U.S. food supply.
Based on its analysis, EPA recommends
in its draft White Paper that FDA
withdraw its guidance on the sampling
and testing of yellow corn grain for
Cry9C at dry mills and masa production
facilities.
FDA is now seeking comment on
whether to withdraw its guidance
document entitled ‘‘FDA
Recommendations for Sampling and
Testing Yellow Corn and Dry-Milled
Yellow Corn Shipments Intended for
Human Food Use for Cry9C Protein
Residues.’’
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on this document. Submit a
single copy of electronic comments or
two paper copies of any mailed
comments, except that individuals may
submit one paper copy. Comments are
to be identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance document at
https://www.cfsan.fda.gov/
guidance.html.
Dated: September 6, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–20379 Filed 10–16–07; 8:45 am]
BILLING CODE 4160–01–S
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Agencies
[Federal Register Volume 72, Number 200 (Wednesday, October 17, 2007)]
[Notices]
[Pages 58978-58980]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-20381]
[[Page 58977]]
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Part IV
Environmental Protection Agency
-----------------------------------------------------------------------
Department of Health and Human Services
-----------------------------------------------------------------------
Food and Drug Administration
>----------------------------------------------------------------------
EPA Draft White Paper Regarding StarLink[reg] Corn Dietary
Exposure and Risk; Availability for Comment; Notice
Guidance for Industry on FDA Recommendations for Sampling and Testing
Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human
Food Use for Cry9C Protein Residues; Comments on Possible Withdrawal;
Notice
Federal Register / Vol. 72, No. 200 / Wednesday, October 17, 2007 /
Notices
[[Page 58978]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0832; FRL-8145-7]
EPA Draft White Paper Regarding StarLink[reg] Corn
Dietary Exposure and Risk; Availability for Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: EPA is seeking comment on a draft White Paper that reviews
data on the level in the human food supply of Cry9C protein from
StarLink[reg] corn grain. It concludes that the protein has been
sufficiently removed from the human food supply to render the level of
risk low enough that continued testing for the protein in yellow corn
at dry mills and masa production facilities provides no added public
health protection. The White Paper therefore recommends that the Food
and Drug Administration (FDA) withdraw its guidance recommending
testing yellow corn grain for Cry9C at dry mills and masa production
facilities. Concurrent with this notice, the FDA is publishing for
comment a notice in the Federal Register that FDA is considering
withdrawing its guidance.
DATES: Comments must be received on or before December 3, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0832, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-0832. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. 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. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
https://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at https://
www.regulations.gov, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Mike Mendelsohn, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8715; fax
number: (703) 308-7026; e-mail address: mendelsohn.mike@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are
anagricultural producer or food manufacturer. Potentially affected
entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes 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 docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a
[[Page 58979]]
Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
What Action is the Agency Taking?
EPA is seeking comment on a draft White Paper that reviews data on
the level in the human food supply of Cry9C protein from
StarLink[reg] corn grain. It concludes that the protein has
been sufficiently removed from the human food supply to render the
level of risk low enough that continued testing for the protein in
yellow corn at dry mills and masa production facilities provides no
added public health protection. StarLink[reg] refers to a
variety of corn genetically engineered to express the protein Cry9C.
Because Cry9C is toxic to various insect pests of corn, Cry9C acts as a
pesticide and was regulated by the U.S. Environmental Protection Agency
(EPA or Agency) under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act
(FFDCA). Under FIFRA and FFDCA, a company seeking to sell or distribute
a pesticide must submit data demonstrating that it will not cause
unreasonable adverse effects on the environment and that any residues
in food will be safe, i.e., there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all other
exposures for which there is reliable information.
Aventis Agroscience, Inc. (Aventis) submitted data on the safety of
StarLink[reg] and applied for approvals under FIFRA and
FFDCA. EPA concluded that the available data did not provide enough
information to support a conclusion that Cry9C was not a potential
human allergen, but that all other information indicated that it would
not pose any other types of risks to human health or the environment.
Accordingly, in 1998 EPA registered StarLink[reg] for
commercial use, provided that all grain derived from
StarLink[reg] corn was directed to domestic animal feed or
to industrial uses (e.g., biofuels). The intent of requiring all
StarLink[reg] to be segregated as either animal feed or for
industrial use was to preclude any occurrence of the potentially
allergenic Cry9C in human food. The registration contained several
specific requirements designed to ensure that no
StarLink[reg] grain entered the human food supply. Following
registration, relatively small quantities of StarLink[reg]
were planted in the United States: 9,018 acres in 1998, 247,694 acres
in 1999, and 350,000 acres in 2000, with the largest planting
representing less than half a percent of the total acreage planted to
corn in the United States.
In September 2000, residues from StarLink[reg] were
detected in taco shells, indicating that it had entered the human food
supply. In response to these detections, Aventis requested cancellation
of the StarLink[reg] registration, https://www.epa.gov/
fedrgstr/EPA-PEST/2001/January/Day-18/p1522.htm. In addition, working
with U.S. Department of Agriculture (USDA), Food and Drug
Administration (FDA), EPA, and the food industry, Aventis undertook a
program to remove all StarLink[reg] from the food supply.
Among other measures, FDA recommended that facilities engaged in the
dry milling or masa production of yellow corn test all incoming
shipments of yellow corn for the possible presence of Cry9C and that
they divert all shipments testing positive to domestic feed or
industrial use.
At the same time, Aventis also requested that EPA reconsider its
position that the available data did not provide enough information to
support a conclusion that Cry9C was not a potential human allergen.
Aventis provided additional data and analysis to support its position
that the allergenic risks of Cry9C were very small. Most of the
arguments advanced by Aventis involved the assertion that exposure to
Cry9C was so low, especially after the full implementation of the
containment and removal program, that there would be no threat to
public health. In 2000 and 2001 EPA held a series of meetings of its
FIFRA Scientific Advisory Panel (SAP or Panel) to evaluate the
scientific issues raised by the new data, analysis, and arguments.
Following the cancellation of the StarLink[reg]
registration, Aventis established a separate corporate entity, StarLink
Logistics Inc. (SLLI), as the successor to Aventis' interest in
StarLink[reg] products. SLLI oversees the
StarLink[reg]. Enhanced Stewardship Program, through which
SLLI and the U.S. corn millers have continued the efforts to contain
and remove Cry9C from the human food supply. SLLI also maintains a
monitoring database containing the test results from more than 4
million tests from over 4 billion bushels of corn collected by dry
milling facilities and other corn handling operations. These tests were
carried out according to guidance developed by FDA and USDA's Grain
Inspection, Packers and Stockyards Administration (GIPSA), and the
federal government considers the data reliable.
In 2005, SLLI commissioned Exponent, Inc., to prepare a new
exposure assessment of the levels of Cry9C present in the U.S. food
supply for submission to EPA. SLLI provided supplemental information in
2006 that updates the 2005 exposure assessment and that quantitatively
characterizes the impact of the monitoring and diversion program on
exposure to Cry9C. The USDA's Agricultural Research Service (ARS)
provided the analytical data on Cry9C concentrations in corn grain used
in Exponent's exposure analysis. In addition, the ARS provided results
from testing corn seeds from the 1970s and 1980s (that is, before Cry9C
was ever bioengineered into corn) for the possible presence of
naturally occurring Cry9C or other proteins that give a positive
reaction in the Cry9C test. GIPSA conducted additional testing to
verify the results of the ARS laboratory.
The draft EPA White Paper concludes that the protein has been
sufficiently removed from the human food supply to render the level of
risk low enough that continued testing for the protein in yellow corn
at dry mills and masa production facilities provides no added public
health protection. The White Paper therefore recommends that FDA
withdraw its guidance recommending testing yellow corn grain for Cry9C
at dry mills and masa production facilities. A full copy of the draft
EPA White Paper is available in the docket and at https://www.epa.gov/
pesticides/biopesticides/pips/star-link-white-paper.pdf.
List of Subjects
Environmental protection, Agricultural commodities, Pesticides and
pests.
[[Page 58980]]
Dated: October 3, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E7-20381 Filed 10-16-07; 8:45 am]
BILLING CODE 6560-50-S