[Federal Register Volume 66, Number 64 (Tuesday, April 3, 2001)]
[Notices]
[Pages 17706-17708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8138]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00708; FRL-6774-4]


EPA Analysis of the Impact of Wet Milling on the Cry9C Protein 
Content in Food

 AGENCY:  Environmental Protection Agency (EPA).

 ACTION:  Notice.

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 SUMMARY:  This action is part of EPA's ongoing effort to make 
information publicly available and to seek public input on the 
potential health risks to humans from consuming foods made from 
StarLink corn. StarLink is a variety of Bt corn that has been 
genetically engineered to produce a protein, Cry9C, intended to be 
toxic to certain insect pests of corn. EPA is soliciting public 
comments on its analysis of the impact on wet milling on the Cry9C 
protein content in human food. The assessment concludes that use of 
StarLink corn in wet-milling results in no (or essentially no) residues 
of Cry9C protein in human food fractions - corn oil, corn syrup, 
alcohol, corn starch. This information would support a conclusion that 
there is no human health risk from eating such food fractions. This 
Notice also lists the specific experts in the processing of corn for 
food from whom EPA is specifically seeking comment. The Agency will 
take into consideration all comments received as it revises the wet 
milling assessment, and the Agency will announce the availability of 
the final assessment in the Federal Register. The Agency will also 
consider the final assessment as it makes its decision on the pending 
Aventis petition.

DATES:  Comments, identified by docket control number OPP-00708, must 
be received on or before May 3, 2001.

 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

[[Page 17707]]

that you identify docket control number OPP-00708 in the subject line 
on the first page of your response.

 FOR FURTHER INFORMATION CONTACT:  Phil Hutton, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-8260; fax number: 
(703) 308-7026; e-mail address: [email protected].

 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 familiar with the wet 
milling of corn or who may be required to conduct testing of chemical 
substances 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 under FOR FURTHER 
INFORMATION CONTACT.

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, the EPA Analysis of the Impact of Wet Milling on the Cry9C 
Protein Content in Food, and certain other related documents that might 
be available electronically, from the EPA Internet Biopesticides Home 
Page at http://www.epa.gov/pesticides/biopesticides/. To access this 
document, on the Home Page select ``Laws and Regulations,'' 
``Regulations and Proposed Rules,'' 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 OPP-00708. The official record 
consists of the documents specifically referenced in this action, 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 Hwy., 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 OPP-00708 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, 1200 Pennsylvania Ave., NW., 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 Hwy., 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 OPP-00708. 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. 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 listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the notice or collection 
activity.
    7. Make sure to submit your comments by the deadline in this 
notice.
    8. 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?

    This action is part of EPA's ongoing effort to make information 
publicly available and to seek public input on the potential health 
risks to humans from consuming foods made from StarLink corn. StarLink 
is a variety of Bt corn that has been genetically engineered to produce 
a protein, Cry9C, intended to be toxic to certain insect pests of corn. 
Following a thorough scientific review of the safety of this product, 
EPA concluded that, other than an unresolved issue regarding the 
potential for Cry9C to pose an allergenic risk to humans, StarLink 
would pose no

[[Page 17708]]

risks to public health or the environment. Therefore, EPA issued a 
registration for the Cry9C protein and the genetic material necessary 
for its production (called a plant-pesticide) in 1998 to AgrEvo (now 
Aventis CropScience). EPA limited the registration by requiring that 
all StarLink corn only be used in domestic animal feed and for 
industrial purposes. EPA did not approve the use of StarLink corn in 
foods destined for human consumption because of unanswered questions 
about the potential allergenicity of the Cry9C protein.
    Because of Aventis' continuing interest in obtaining approval for 
use of StarLink in the production of human food and the novel 
scientific issues raised concerning the assessment of potential 
allergenicity, EPA called a meeting of the FIFRA Scientific Advisory 
Panel (SAP), on February 29, 2000 regarding Cry9C protein. (The SAP 
provides independent scientific advice and recommendations to the 
Agency as to the impact on health and the environment of regulatory 
actions concerning pesticides and pesticide-related issues.) The 
February 29, 2000 SAP report stated that it could not be determined 
whether or not Cry9C is a potential food allergen.
    In September 2000, Cry9C DNA was detected in a finished food 
product - taco shells. Subsequently, the DNA and protein have been 
found in corn grain and other corn products in the food supply. These 
detections indicated that, despite the EPA restrictions, some 
quantities of StarLink corn had directly entered the human food chain.
    On October 12, 2000, Aventis requested that the registration for 
their StarLink corn product be voluntarily cancelled. As a result, 
StarLink corn is not authorized for planting in future years. On 
October 25, 2000, Aventis amended its petition for a food tolerance 
exemption under the Federal Food, Drug, and Cosmetic Act (FFDCA) to ask 
for a temporary tolerance of 4 years to cover any Cry9C protein and 
Cry9C DNA that may be present in human food made from StarLink corn 
planted in 1998, 1999, and 2000. Aventis submitted additional 
information with its petition to support its contention that the Cry9C 
protein posed no allergenic risk to public health. EPA convened another 
SAP meeting on November 28, 2000 to consider the question of the 
potential of the Cry9C protein to be an allergen, whether there is an 
adequate amount of the protein in corn to cause sensitization, what 
amount of Cry9C might be in the human food supply if this time limited 
tolerance exemption were to be approved, and reports of adverse 
incidents for alleged human exposure. More information including the 
Aventis submission, EPA's papers for SAP review, background 
information, and the SAP final reports can be found on the following 
web sites:
http://www.epa.gov/pesticides/biopesticides/cry9c/index.htm
http://www.epa.gov/scipoly/sap/index.htm

     The final report from the November 28, 2000 SAP meeting, which was 
issued on December 1, 2000, expressed the consensus of the Panel that 
while Cry9C has a ``medium likelihood'' to be a food allergen, the 
combination of the expression level of the protein and the amount of 
corn found to be commingled poses a ``low probability'' to sensitize 
individuals to Cry9C.
    The Panel report noted that the likelihood of the protein being 
detected in different corn products varied considerably, especially 
depending on the method of processing and whether the product was from 
white or yellow corn. The Cry9C DNA was only engineered into certain 
yellow corn varieties. The SAP report called on EPA to only include in 
our dietary assessment those ingredients from corn that contain protein 
after processing. The SAP report states that items such as corn syrup, 
corn oil, and starch contain virtually no protein.
    In follow-up to the SAP report, EPA collected and evaluated 
information on the impacts of the wet milling process on levels of 
protein in finished human food products. The assessment concludes that 
use of StarLink corn in wet-milling results in no (or essentially no) 
residues of Cry9C protein in human food fractions - corn oil, corn 
syrup, alcohol, corn starch. This information would support a 
conclusion that there is no human health risk from eating such food 
fractions. EPA is now soliciting public comments on its analysis of the 
impact of wet milling on the Cry9C protein content in food.
    In addition to the general public, The Agency will specifically 
contact and request comments from the following experts in the 
processing of corn for food:
     1. Dr. R. Carl Hoseney of R and R Research in Manhattan, KS.
     2. Dr. Barry Jacobsen of Montana State University in Bozeman, 
Montana.
     3. Dr. David Lineback of the University of Maryland in College 
Park, Maryland.
    4. Dr. Llyod Rooney of Texas A&M University in College Station, 
Texas.
    The Agency will take into consideration all comments received and 
publish the availability of its final wet milling assessment in the 
Federal Register. The final wet milling assessment will also be 
considered as part of EPA's overall review of Aventis' pending petition 
for an exemption for Cry9C in human food, PP 9F05050.

B. What is the Agency's Authority for Taking this Action?

    The Federal Food, Drug, and Cosmetic Act provides the legal 
authority for EPA to take this action.

List of Subjects

     Environmental protection, plant-incorporated protectants.

    Dated: March 7, 2001.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division.
[FR Doc. 01-8138 Filed 4-2-01; 8:45 a.m.]
BILLING CODE 6560-50-S