[Federal Register: November 24, 2004 (Volume 69, Number 226)]
[Notices]
[Page 68381-68383]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no04-95]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0369]
Draft Guidance for Industry: Recommendations for the Early Food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availability of a draft guidance for industry entitled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.'' The draft guidance, when finalized, is intended to provide
recommendations to developers of new plant varieties, in particular
bioengineered plants, on the early food safety evaluation of new non-
pesticidal proteins. The draft guidance describes procedures for
submitting an early food safety evaluation of such proteins to the
agency.
DATES: Submit written or electronic comments concerning the draft
guidance and the collection of information provisions by January 24,
2005.
ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Recommendations for the Early Food Safety
Evaluation of New Non-Pesticidal Proteins Produced by New Plant
Varieties Intended for Food Use'' to Mary D. Ditto, Center for Food
Safety and Applied Nutrition (HFS-255), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1165. Send one
self-adhesive address label to assist that office in processing your
request, or include a fax number to which the draft guidance may be
sent. See the SUPPLEMENTARY INFORMATION section for electronic access
to the draft guidance.
Submit written comments concerning the draft guidance and the
collection of information provisions 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.
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, 301-436-1165, FAX 301-436-
2965, e-mail: mditto@cfsan.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In a document 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 a draft 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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This draft guidance describes the procedure for early food safety
evaluation of new proteins produced by new plant varieties that are
under
[[Page 68382]]
development. While this guidance is focused on new proteins in
bioengineered plants, these procedures may, of course, be used for new
proteins in non-bioengineered foods as well. This draft guidance also
provides information to sponsors and developers about submitting their
evaluation to FDA.
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulations (21 CFR 10.115). The draft
guidance, when finalized, will represent FDA's current thinking on the
early food safety assessment of new 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 can 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 the guidance. 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 draft guidance document contains information collection
provisions that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44
U.S.C. 3501-3520). Under the PRA, Federal agencies must obtain approval
from the OMB for each collection of information they conduct or
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3)
and 5 CFR 1320.3 and includes agency requests or requirements that
members of the public submit reports, keep records, or provide
information to a third party. Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing notice of the proposed
collection of information set forth below.
FDA invites comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology. Elsewhere, in
this issue of the Federal Register, FDA is publishing a notice
announcing an opportunity for public comment on the information
collection, entitled ``Guidance on Consultation Procedures; Foods
Derived from New Plant Varieties.''
Recommendations for Early Food Safety Evaluation of New Non-Pesticidal
Proteins Produced by New Plant Varieties Intended for Food Use
Since 1992, when FDA issued its Statement of Policy: Foods Derived
from New Plant Varieties (57 FR 22984, May 29, 1992), FDA has
encouraged developers of new plant varieties, including those varieties
that are developed through biotechnology, to consult with FDA early in
the development process to discuss possible scientific and regulatory
issues that might arise. The current guidance continues to foster early
communication by encouraging developers to submit to FDA their
evaluation of the food safety of their new protein. Such communication
helps to ensure that any potential food safety issues regarding a new
protein in a new plant variety are resolved early in development, prior
to any possible inadvertent introduction into the food supply of
material from that plant variety.
FDA believes that any food safety concern related to such material
entering the food supply would be limited to the potential that a new
protein in food from the plant variety could cause an allergic reaction
in susceptible individuals or could be a toxin. This guidance describes
the procedures for early food safety evaluation of new proteins in new
plant varieties, including bioengineered food plants, and the
procedures for communicating with FDA about the safety evaluation.
Information Collection Burden Estimate
FDA estimates the burden for this information collection as
follows:
Table 1.--Estimated Reporting Burden\1\
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Annual Operating and
No. of Frequency per Total Annual Hours per Maintenance Total Hours
Respondents Response Responses Response Costs
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First four data components 20 1 20 4 $0 80
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Two other data components 20 1 20 16 $0 320
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Annual one-time burden hours 400
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\1\ There are no capital costs or operating or maintenance costs associated with this collection of information.
Burden:
Hour Burden Estimate
One Time Burden
Completing an early food safety evaluation for a new protein from a
new plant variety will be a one-time burden (one evaluation per new
protein). FDA cannot know how many developers will choose to complete
an early food safety evaluation for their new plant protein. Some plant
developers may choose not to complete an evaluation because of the
uncertainty of the new plant variety's future viability in the
marketplace. Other developers may have previously communicated with FDA
about the food safety of a new protein, for example, when the same
protein was expressed in a different crop. Still other developers may
test a new plant variety under such
[[Page 68383]]
conditions that those developers have no concerns that the new protein
could enter the food supply.
FDA scientists predict that this draft guidance will generate about
20 to 150 early food safety evaluations yearly. While there is
uncertainty as to the number of developers who will choose to submit an
evaluation, FDA estimates that the annual number of early food safety
evaluations will be closer to the lower bound estimate of 20
evaluations rather than the upper bound estimate of 150 evaluations.
This estimation is supported by the fact that on average there have
been nine initial biotechnology consultations per year; an initial
biotechnology consultation has traditionally been the first discussion
between a developer and FDA about a bioengineered food.
Evaluation Components
The early food safety evaluation for new proteins includes six main
data components. Four of these data components are easily and quickly
obtainable, having to do with the identity and source of the protein.
FDA estimates that completing these data components will take about 4
hours per evaluation. In table 1 of this document, row 1 shows that for
20 evaluations, the total burden for these 4 data components is 80
hours.
Two data components ask for original data to be generated. One data
component consists of a bioinformatics analysis which can be performed
using publicly available databases. The other data component involves
`wet' lab work to assess the new protein's stability and the resistance
of the protein to enzymatic degradation using appropriate in vitro
assays (protein digestibility study).
The paperwork burden of these two data components consists of the
time it takes the company to put together the information on these two
data components to submit to FDA. We estimate that these two data
components will take 16 hours to complete (8 hours for each component).
Table 1, row 2, shows that for 20 evaluations, the total burden for
these two data components is 320 hours.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the draft
guidance and the collection of information provisions. 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 draft guidance 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
An electronic version of the draft guidance is available on the
Internet at http://www.cfsan.fda.gov/guidance.html and http://www.fda.gov/cvm.
Dated: November 17, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-26049 Filed 11-19-04; 1:52 pm]
BILLING CODE 4160-01-S
Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use November 2004
