[Federal Register Volume 71, Number 119 (Wednesday, June 21, 2006)]
[Notices]
[Pages 35688-35689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-9688]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0369]
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.
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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-
[[Page 35689]]
3835, 301-436-1165, FAX 301-436-2965, or e-mail:
[email protected].
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.
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\1\``Guidance on Consultation Procedures: Foods Derived from New
Plant Varieties'' can be found at http://www.cfsan.fda.gov/~lrd/
consulpr.html.
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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 Sec. 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.
[FR Doc. E6-9688 Filed 6-20-06; 8:45 am]
BILLING CODE 4160-01-S