[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \1\``Guidance on Consultation Procedures: Foods Derived from New 
Plant Varieties'' can be found at http://www.cfsan.fda.gov/~lrd/
consulpr.html.
---------------------------------------------------------------------------

    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