01-8138. EPA Analysis of the Impact of Wet Milling on the Cry9C Protein Content in Food

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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 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: [phone]; fax number: [phone]; e-mail address: [e-mail].

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 [phone].

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 [phone].

-3. Electronically. You may submit your comments electronically by e-mail to: [e-mail], 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 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

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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.