E6-9688. Guidance for Industry; Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled “Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use.” The guidance provides recommendations to developers of new plant varieties, including bioengineered plant varieties, on the early food safety evaluation of new non-pesticidal proteins. The guidance describes procedures for submitting an early food safety evaluation of such proteins to the agency.

DATES:

This guidance document is final upon the date of publication. Submit written or electronic comments concerning the guidance at any time.

ADDRESSES:

Submit written requests for single copies of the guidance entitled “Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use” to the Office of Food Additive Safety (HFS-255), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Include a self-addressed adhesive label to assist that office in processing your request.

Submit written comments concerning the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments. To ensure a timelier processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

Mary D. Ditto, Center for Food Safety and Applied Nutrition (HFS-255), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1165, FAX [phone], or e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of August 2, 2002 (67 FR 50578), the U.S. Office of Science and Technology Policy (OSTP) proposed Federal actions to update field test requirements and to establish early voluntary food safety evaluations for new proteins produced by bioengineered plants. Rapid developments in genomics are resulting in dramatic changes in the way new plant varieties are developed and commercialized. Scientific advances are expected to accelerate over the next decade, leading to the development and commercialization of a greater number and diversity of bioengineered crops. As the number and diversity of field tests for bioengineered plants increase, the likelihood that cross-pollination due to pollen drift from field tests to commercial fields and commingling of seeds produced during field tests with commercial seeds or grain may also increase. This could result in the inadvertent, intermittent, low-level presence in the food supply of proteins that have not been evaluated through FDA's voluntary consultation procedures for foods derived from new plant varieties (referred to as “biotechnology consultation” in the case of bioengineered plants).^[1] FDA is issuing this guidance document to address this possibility.

In the Federal Register of November 24, 2004 (69 FR 68381), FDA made available a draft guidance for industry entitled “Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use” and gave interested parties an opportunity to submit comments by January 24, 2005. The agency considered received comments as it finalized this guidance.

This guidance describes the procedure for early food safety evaluation of new proteins produced by new plant varieties that are under development for food use, including, for example, such proteins produced in bioengineered plants. This guidance also provides information to sponsors and developers about submitting their evaluation to FDA.

FDA is issuing this guidance document as a level 1 guidance consistent with FDA's good guidance practices regulation § 10.115 (21 CFR 10.115). This guidance represents FDA's current thinking on the early food safety evaluation of new non-pesticidal proteins produced by new plant varieties intended for food use. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance (see FOR FURTHER INFORMATION CONTACT). If you cannot identify the appropriate FDA staff, call the telephone number listed in the title page of the guidance.

II. Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information in the guidance was approved under OMB Control No. 0910-0583.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this guidance at any time. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance document and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

Persons with access to the Internet may obtain the guidance document at either http://www.cfsan.fda.gov/​guidance.html or http://www.fda.gov/​cvm/​Guidance/​published.htm.

Dated: June 14, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.

Footnotes

1. “Guidance on Consultation Procedures: Foods Derived from New Plant Varieties” can be found at http://www.cfsan.fda.gov/​~lrd/​consulpr.html.