EPA White Paper Regarding StarLink®, 22716 [E8-9003]

Download as PDF 22716 Federal Register / Vol. 73, No. 81 / Friday, April 25, 2008 / Notices ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2007–0832; FRL–8358–7] EPA White Paper Regarding StarLink Corn Dietary Exposure and Risk; Availability Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: SUMMARY: EPA is making available a final 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 heath 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, FDA is publishing a notice in the Federal Register withdrawing their guidance. 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) 3087026; e-mail address: mendelsohn.mike@epa.gov. SUPPLEMENTARY INFORMATION: rwilkins on PROD1PC63 with NOTICES4 I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural 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 VerDate Aug<31>2005 19:04 Apr 24, 2008 Jkt 214001 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. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2007–0832. 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 Office of Pesticide Programs (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. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at https://www.epa.gov/fedrgstr. II. Background EPA is making available a final White Paper that reviews data on the level in the human food supply of Cry9C protein from StarLink corn grain. The Agency notified the public regarding the availability of a draft version of the White Paper in the October 17, 2007 Federal Register (72 FR 58978) (FRL–8145–7), with a docket identification number of EPA–HQ– OPP–2007–0832. The open comment period from October 17, 2007 to December 3, 2007, was held to allow members of the general public to submit letters and/or documents to the Agency on this White Paper. The Agency received comment from the North American Export Grain Association, Inc., the Corn Refiners Association, the Biotechnology Industry Association (BIO), the National Grain and Feed Association, the U. S. Grains Council, the North American Millers’ Association, the Food Corn Industry Coalition, the National Corn Growers, and two unsigned comments. These comments are addressed in the final White Paper. The final White Paper 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 added public heath protection. The final White PO 00000 Frm 00002 Fmt 4701 Sfmt 4703 Paper therefore recommends that FDA withdraw its guidance recommending testing yellow corn grain at dry mills and masa production facilities. A full copy of the final EPA White Paper is available in docket EPA–HQ–OPP– 2007–0832. List of Subjects Environmental protection, Agricultural commodities, Pesticides and pests. Dated: April 21, 2008. James B. Gulliford, Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances. [FR Doc. E8–9003 Filed 4–24–08; 8:45 am] BILLING CODE 6560–50–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0229 (formerly Docket No. 2001D–0025)] Guidance for Industry on the Food and Drug Administration Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein Residues; Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal. SUMMARY: The Food and Drug Administration (FDA) is announcing the withdrawal of a 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 withdrawing its guidance in response to the release by the Environmental Protection Agency (EPA) of its final ‘‘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: April 25, 2008. 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 Pkwy., College Park, MD 20740, 301– 436–1639 or 301–436–1636, respectively. SUPPLEMENTARY INFORMATION: E:\FR\FM\25APN4.SGM 25APN4

Agencies

[Federal Register Volume 73, Number 81 (Friday, April 25, 2008)]
[Notices]
[Page 22716]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9003]



[[Page 22715]]

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Part V





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 White Paper Regarding StarLink[reg] Corn Dietary 
Exposure and Risk; Availability; Notice



Guidance for Industry on FDA Recommendations for Sampling and Testing 
Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Use 
for Cry9C Protein Residues; Withdrawal of Guidance; Notice

Federal Register / Vol. 73, No. 81 / Friday, April 25, 2008 / 
Notices

[[Page 22716]]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0832; FRL-8358-7]


EPA White Paper Regarding StarLink[reg] Corn Dietary 
Exposure and Risk; Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is making available a final 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 heath 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, FDA is publishing a 
notice in the Federal Register withdrawing their guidance.

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 an 
agricultural 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. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under 
docket identification (ID) number EPA-HQ-OPP-2007-0832. 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 Office of Pesticide Programs (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.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at https://www.epa.gov/fedrgstr.

II. Background

    EPA is making available a final White Paper that reviews data on 
the level in the human food supply of Cry9C protein from 
StarLink[reg] corn grain.
    The Agency notified the public regarding the availability of a 
draft version of the White Paper in the October 17, 2007 Federal 
Register (72 FR 58978) (FRL-8145-7), with a docket identification 
number of EPA-HQ-OPP-2007-0832. The open comment period from October 
17, 2007 to December 3, 2007, was held to allow members of the general 
public to submit letters and/or documents to the Agency on this White 
Paper. The Agency received comment from the North American Export Grain 
Association, Inc., the Corn Refiners Association, the Biotechnology 
Industry Association (BIO), the National Grain and Feed Association, 
the U. S. Grains Council, the North American Millers' Association, the 
Food Corn Industry Coalition, the National Corn Growers, and two 
unsigned comments. These comments are addressed in the final White 
Paper.
    The final White Paper 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 added public 
heath protection. The final White Paper therefore recommends that FDA 
withdraw its guidance recommending testing yellow corn grain at dry 
mills and masa production facilities. A full copy of the final EPA 
White Paper is available in docket EPA-HQ-OPP-2007-0832.

List of Subjects

    Environmental protection, Agricultural commodities, Pesticides and 
pests.


    Dated: April 21, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic 
Substances.

[FR Doc. E8-9003 Filed 4-24-08; 8:45 am]
BILLING CODE 6560-50-S
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