EPA Draft White Paper Regarding StarLink® Corn Dietary Exposure and Risk; Availability for Comment
[Federal Register: October 17, 2007 (Volume 72, Number 200)]
[Notices]
[Page 58977-58980]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17oc07-139]
[[Page 58977]]
-----------------------------------------------------------------------
Part IV
Environmental Protection Agency
-----------------------------------------------------------------------
Department of Health and Human Services
-----------------------------------------------------------------------
Food and Drug Administration
>----------------------------------------------------------------------
EPA Draft White Paper Regarding StarLink® 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
[[Page 58978]]
-----------------------------------------------------------------------
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
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® 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: http://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
http://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
http://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 http://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® 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 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,
http://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® 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
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
http://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
![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}