[Federal Register Volume 83, Number 154 (Thursday, August 9, 2018)]
[Notices]
[Pages 39450-39453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17024]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-2495]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Voluntary Labeling Indicating Whether Foods Have or
Have Not Been Derived From Genetically Engineered Plants
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection associated with
the guidance to assist manufacturers who wish to voluntarily label
their foods (human and animal) as being made with or without
bioengineering, or the use of bioengineered ingredients, to ensure that
labeling is truthful and not misleading.
[[Page 39451]]
DATES: Submit either electronic or written comments on the collection
of information by October 9, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 9, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 9, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-2495 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Voluntary Labeling Indicating
Whether Foods Have or Have Not Been Derived from Genetically Engineered
Plants.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(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(c) 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, including
each proposed extension of an existing 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 in this document.
With respect to the following collection of information, 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.
Voluntary Labeling Indicating Whether Foods Have or Have Not Been
Derived From Genetically Engineered Plants
OMB Control Number 0910-0807--Extension
This information collection supports Agency guidance. Section 403
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343)
generally governs the labeling of foods. Under section 403(a)(1) of the
FD&C Act, a food is misbranded if its labeling is false or misleading
in any particular. Section 201(n) of the FD&C Act (21 U.S.C. 321(n))
provides that labeling is misleading if, among other things, it fails
to reveal facts that are material in light of representations made or
suggested in the labeling, or material with respect to consequences
that may result from the use of the food to which the labeling relates
under the conditions of use prescribed in the labeling, or
[[Page 39452]]
under such conditions of use as are customary or usual.
In the Federal Register of May 29, 1992 (57 FR 22984), we published
a ``Statement of Policy: Foods Derived from New Plant Varieties'' (the
1992 Policy). The 1992 Policy applies to foods for humans and animals
that are developed from new plant varieties, including varieties that
are developed using recombinant deoxyribonucleic acid (rDNA)
technology, which is often referred to as ``rDNA technology,''
``genetic engineering,'' ``biotechnology,'' or ``bioengineering,'' and
more recently as ``modern biotechnology.'' The 1992 Policy provides
guidance to industry on scientific and regulatory issues related to
bioengineered foods and solicited written comments from interested
persons. It includes guidance on questions to be answered by developers
of foods from new plant varieties to ensure that the new products are
safe and comply with applicable legal requirements.
The 1992 Policy stated that the method of development of a new
plant variety, including plants developed using bioengineering, is not
information that is material under section 201(n) of the FD&C Act and,
therefore, would not be required in the labeling of food. This
conclusion is consistent with our historic interpretation of section
201(n) of the FD&C Act, in that the method of plant breeding is not
required to be disclosed in labeling. In the 1992 Policy, we addressed,
among other things, the labeling of foods derived from new plant
varieties, including plants developed by bioengineering. In the 1992
Policy, we explained that we were not establishing special labeling
requirements for foods from bioengineered plants as a class of foods
because we did not find any basis for concluding that foods from
bioengineered plants, as a class, differ from other foods in any
meaningful or uniform way, or that foods developed by the new
techniques present any different or greater safety concern than foods
developed by traditional plant breeding.
The guidance entitled ``Voluntary Labeling Indicating Whether Foods
Have or Have Not Been Derived from Genetically Engineered Plants'' is
intended to assist manufacturers that wish to voluntarily label their
foods (human or animal) as being made with or without genetic
engineering or the use of genetically engineered ingredients, to ensure
that such labeling is truthful and not misleading. The guidance is
available at https://www.fda.gov/FoodGuidances. The information that
the manufacturers will collect is documentation of handling practices
so that they can truthfully label their products to indicate, if they
so choose, whether the food has or has not been developed using genetic
engineering.
In general, we anticipate that manufacturers that claim that a
product is not developed using bioengineered material would
substantiate the claim. We suggest that manufacturers document
practices and procedures to substantiate a claim that a food was not
developed using genetic engineering. Examples of documentation that we
anticipate will demonstrate practices and procedures are recordkeeping,
and certifications or affidavits from farmers, processors, and others
in the food production and distribution chain. We are neither
suggesting that firms maintain a certain set list of documents nor are
we suggesting that anything less or different would likely be
considered unacceptable. Rather, we are leaving it to each firm's
judgment to maintain appropriate documentation to demonstrate that the
food was produced using traditional methods.
Description of Respondents: The respondents to the proposed
collection of information are manufacturers of foods that were or were
not derived from genetically engineered plants who wish to voluntarily
label their food products.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Recordkeeping per the Guidance..................................... 85 4 340 1 340
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
The number of recordkeepers and respondents reflects the number of
food products that are labeled using the terms ``biotechnology'' and
``GMO'' (genetically modified organism). We estimate a recordkeeping
burden to retain paperwork to substantiate that the food or ingredient
is produced without genetic engineering only for products that are not
also already labeled using the term ``organic.'' We did not include
products that are labeled ``organic'' in the estimated annual
recordkeeping burden because, according to a final rule in the Federal
Register of December 21, 2000 (65 FR 80548) issued by the Agriculture
Marketing Service of the U.S. Department of Agriculture, a food labeled
as ``organic'' would not be permitted to contain genetically engineered
materials. Thus, there is no additional paperwork burden to
substantiate a claim that a product is not developed using genetic
engineering for these certified organic products.
We based our estimates of the recordkeeping burden (table 1 of this
document) on data from Labelbase by FoodEssentials. Labelbase is a
custom online system for accessing consumer-packaged goods product
data; the database contains more than 250,000 product labels that can
be searched by keyword, ingredient, nutrient, allergen, label claim, or
food additive, for example. Using this database, we have identified 540
food manufacturers who produce 2,160 products with the term
``bioengineered'' or ``GMO'' on their labels; this estimate includes
manufacturers of human food and pet food. In addition, the National
Center for Appropriate Technology's National Sustainable Agriculture
Information Center maintains on its website a list of Organic Livestock
Feed Suppliers. Using this list, we have identified 54 livestock feed
suppliers that would be likely to include a statement about
bioengineering on the label of their products and thus would have
documentation to substantiate their claim.
Of the 2,160 human food and pet food products that we have
identified as using the term ``bioengineered'' or ``GMO'' on their
labels (presumably used in a context to designate foods that are not
bioengineered), 1,140 of these products (285 manufacturers) also use
the term ``organic'' on the label; 1,020 products do not use the term
``organic''
[[Page 39453]]
on the label (2,160 - 1,140 = 1,020 products not organics; 540 - 285 =
255 manufacturers of not organic products). In addition, the 54
livestock feed suppliers are also organic producers, thus the 216
products attributed to these manufacturers already are considered to be
labeled ``organic.'' Thus, there are 1,020 products made by 255 human
food and pet food manufacturers that would need to substantiate that
their product or ingredient was not genetically engineered.
We estimate that the burden of maintaining the documentation is a
one-time burden; the document to substantiate that the product or
ingredient was produced without genetic engineering only needs to be
generated once and then kept on file. To annualize this one-time
burden, we divide by 3 because paperwork burden collections are
approved on a 3-year cycle (255/3 = 85). Thus, we estimate in table 1
that, on average, 85 manufacturers annually will collect and keep
information that substantiates their label claim for four products
(1,020 products/3 = 340 products/85 manufacturers = 4 products per
manufacturer).
We estimate this one-time recordkeeping burden to be 1 hour per
product that makes use of a labeling claim, which results in a burden
of 1 hour for a total annualized recordkeeping burden of 340 hours (85
manufacturers x 4 records per manufacturer x 1 hour per record).
We do not estimate any reporting burden or third-party disclosure
burden associated with this information collection. Manufacturers who
want to make use of this voluntary labeling claim option are considered
to be those that already have such wording on their products' labels.
We do not expect that this guidance will cause labels already in the
marketplace to need to be reworded.
Dated: August 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17024 Filed 8-8-18; 8:45 am]
BILLING CODE 4164-01-P