[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