Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants, 39450-39453 [2018-17024]
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39450
Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices
Generic Clearance for the Collection of
Quantitative Data on Tobacco Products
and Communications; OMB Control
Number 0910–0810—Extension
In order to conduct educational and
public information programs relating to
tobacco use as authorized by section
1003(d)(2)(D) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
393(d)(2)(D)), FDA’s Center for Tobacco
Products will create and use a variety of
media to inform and educate the public,
tobacco retailers, and health
professionals about the risks of tobacco
use, how to quit using tobacco products,
and FDA’s role in regulating tobacco.
To ensure that these health
communication messages have the
highest potential to be received,
understood, and accepted by those for
whom they are intended, the Center for
Tobacco Products will conduct research
and studies relating to the control and
prevention of disease. In conducting
such research, FDA will employ
formative pretests. Formative pretests
are conducted on a small scale, and
their focus is on developing and
assessing the likely effectiveness of
communications with specific target
audiences. This type of research
involves: (1) Assessing audience
knowledge, attitudes, behaviors, and
other characteristics for the purpose of
determining the need for and
developing health messages,
communication strategies, and public
information programs and (2) pretesting
these health messages, strategies, and
program components while they are in
developmental form to assess audience
comprehension, reactions, and
perceptions.
Formative pretesting is a staple of best
practices in communications research.
Obtaining voluntary feedback from
intended audiences during the
development of messages and materials
is crucial for the success of every
communication program. The purpose
of obtaining information from formative
pretesting is that it allows FDA to
improve materials and strategies while
revisions are still affordable and
possible. Formative pretesting can also
avoid potentially expensive and
dangerous unintended outcomes caused
by audiences’ interpreting messages in a
way that was not intended by the
drafters. By maximizing the
effectiveness of messages and strategies
for reaching targeted audiences, the
frequency with which tobacco
communication messages need to be
modified should be greatly reduced.
The voluntary information collected
will serve the primary purpose of
providing FDA information about the
perceived effectiveness of messages,
advertisements, and materials in
reaching and successfully
communicating with their intended
audiences. Quantitative testing
messages and other materials with a
sample of the target audience will allow
FDA to refine messages, advertisements,
and materials, including questionnaires
or images, directed at consumers while
the materials are still in the
developmental stage.
In the Federal Register of February
13, 2018 (83 FR 6190), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. One PRA-related comment
was received.
Comment: The comment recommends
that FDA should research and develop
communications about educating adults
about the continuum of risk, and
educating adults to not provide tobacco
products to youth.
Response: FDA appreciates the
comment. The content and focus on
studies submitted through this generic
clearance will depend on Agency
priorities and needs, and is not yet
determined at this time.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Screener ...............................................................................
130,500
1
130,500
Self-Administered Surveys ...................................................
27,000
1
27,000
Total ..............................................................................
........................
........................
........................
1 There
Total hours
0.083 (5
minutes)
0.33 (20
minutes)
10,831
........................
19,741
8,910
are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents to be
included in each new survey will vary,
depending on the nature of the material
or message being tested and the target
audience. The burden for this
information collection extension is
proposed to increase by 12,613 hours
since the last OMB approval. The
burden increase is due to an increase in
the number of respondents and the
categories of respondents.
sradovich on DSK3GMQ082PROD with NOTICES
Average
burden per
response
Dated: August 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
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.
Notice.
[FR Doc. 2018–17044 Filed 8–8–18; 8:45 am]
ACTION:
BILLING CODE 4164–01–P
SUMMARY:
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The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
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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.
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Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices
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.
DATES:
sradovich on DSK3GMQ082PROD with NOTICES
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
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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/201523389.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, PRAStaff@
fda.hhs.gov.
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39451
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.
SUPPLEMENTARY INFORMATION:
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
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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
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
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
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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 consumerpackaged 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
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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’’
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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 onetime 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 × 4 records per
manufacturer × 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]
sradovich on DSK3GMQ082PROD with NOTICES
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–P–0998]
Determination That PROLIXIN
(Fluphenazine Hydrochloride) Tablets,
1 Milligram, 2.5 Milligrams, 5
Milligrams, and 10 Milligrams, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that PROLIXIN
(fluphenazine hydrochloride) tablets, 1
milligram (mg), 2.5 mg, 5 mg, and 10
mg, was not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for fluphenazine
hydrochloride tablets, 1 mg, 2.5 mg, 5
mg, and 10 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363,
Stacy.Kane@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of an NDA.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
SUMMARY:
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39453
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5
mg, and 10 mg, is the subject of NDA
011751, held by Apothecon
Pharmaceuticals, a Bristol-Myers Squibb
Company, and initially approved on
March 15, 1967. PROLIXIN is indicated
in the management of manifestations of
psychotic disorders.
In a letter dated October 5, 2006,
Bristol-Myers Squibb Company
requested withdrawal of NDA 011751
for PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5
mg, and 10 mg. In the Federal Register
of February 11, 2009 (74 FR 6896), FDA
announced that it was withdrawing
approval of NDA 011751, effective
March 13, 2009.
Hyman, Phelps & McNamara, P.C.
submitted a citizen petition dated
March 5, 2018 (Docket No. FDA–2018–
P–0998), under 21 CFR 10.30,
requesting that the Agency determine
whether PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5
mg, and 10 mg, was withdrawn from
sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5
mg, and 10 mg, was not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that PROLIXIN
(fluphenazine hydrochloride) tablets, 1
mg, 2.5 mg, 5 mg, and 10 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of PROLIXIN
(fluphenazine hydrochloride) tablets, 1
mg, 2.5 mg, 5 mg, and 10 mg, from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
