

[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]                         


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Part IV





Environmental Protection Agency





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Department of Health and Human Services





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Food and Drug Administration



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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


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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.

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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: 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[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, 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[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 http://www.epa.gov/pesticides/biopesticides/pips/star-link-white-paper.pdf
.


List of Subjects

    Environmental protection, Agricultural commodities, Pesticides and 
pests.



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    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
