[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Draft Guidance for Industry: Recommendations for the Early Food 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availability of a draft guidance for industry entitled 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 The draft guidance, when finalized, is intended to provide 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 The draft guidance describes procedures for 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DATES:  Submit written or electronic comments concerning the draft 
guidance and the collection of information provisions by January 24, 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance entitled ``Recommendations for the Early Food Safety 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request, or include a fax number to which the draft guidance may be 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to the draft guidance.
    Submit written comments concerning the draft guidance and the 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/guidance.html and http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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