Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants; Guidance for Industry; Availability, 73194-73198 [2015-29903]
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Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Notices
FOR FURTHER INFORMATION CONTACT:
Regarding human food issues: Andrea
Krause, Center for Food Safety and
Applied Nutrition (HFS–820), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–2371. Regarding animal food
issues: Kathleen Jones, Center for
Veterinary Medicine (HFV–220), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 240–402–
7077.
SUPPLEMENTARY INFORMATION:
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I. Background
We are announcing the availability of
a draft guidance for industry entitled
‘‘Voluntary Labeling Indicating Whether
Food Has or Has Not Been Derived From
Genetically Engineered Atlantic
Salmon.’’ We are issuing the draft
guidance consistent with our good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on this topic. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternate approach if it
satisfies the requirements of the
applicable statutes and regulations.
On November 19, 2015, FDA
approved a new animal drug application
(NADA) related to AquAdvantage
Salmon, a GE Atlantic salmon. This is
FDA’s first approval of an NADA in
support of a GE animal for use as food.
According to information in the NADA,
AquAdvantage Salmon is genetically
engineered to reach market size in a
shorter period than non-GE farm-raised
Atlantic salmon. FDA’s Center for
Veterinary Medicine reviewed the
NADA and made a determination
concerning the safety and effectiveness
of the new animal drug in
AquAdvantage Salmon.
In terms of labeling of food derived
from AquAdvantage Salmon, the law
requires, among other things, that the
label includes a name that accurately
describes the basic nature of a food and
any other information that is considered
material with regard to consequences
that may result from the use of the food.
In a 1992 policy on foods derived from
new plant varieties and a 2001 draft
guidance on voluntary labeling of food
from GE plants, we explained that:
Name changes are appropriate when a
food from a GE plant is materially
different from its traditional
counterpart, such that the common or
usual name no longer adequately
describes the new food; or when there
are other material differences that affect
the food’s nutritional or functional
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characteristics.1 (Elsewhere in this issue
of the Federal Register, we are
announcing the availability of a final
guidance entitled ‘‘Guidance for
Industry: Voluntary Labeling Indicating
Whether Foods Have or Have Not Been
Derived from Genetically Engineered
Plants.’’) Changes to the name of the
product or other additional labeling are
not required if the resulting food is not
materially different from its nongenetically engineered counterpart.
In the process of deciding whether or
not to require additional labeling of
AquAdvantage Salmon, FDA considered
whether food from AquAdvantage
Salmon is materially different from nonGE, farm-raised Atlantic salmon. As part
of our evaluation, we assessed data and
information submitted in response to
our August 26, 2010, Federal Register
document entitled ‘‘Food Labeling;
Labeling of Food Made From
AquAdvantage Salmon; Public Hearing;
Request for Comments’’ (75 FR 52602),
as well as data and information
submitted by the sponsor.
Based on our review of the sponsor’s
data and information, and other
information available to the Agency
(e.g., FDA’s laboratory analyses
establishing that AquAdvantage Salmon
meets the criteria for Atlantic salmon
established for the Regulatory Fish
Encyclopedia), we found that the
composition, nutritional profile, and
safety of food from AquAdvantage
Salmon do not differ from food from
non-GE, farm-raised Atlantic salmon in
any material way, and thus it is as safe
and nutritious as food from non-GE,
farm-raised Atlantic salmon. For these
reasons, we concluded that there is no
basis to require additional labeling of
food derived from AquAdvantage
Salmon.2 3
II. Guidance on Voluntary Labeling
Recognizing that some consumers are
interested in whether a food contains
GE Atlantic salmon and some
manufacturers may want to respond to
this consumer interest, we developed
this draft guidance to assist food
manufacturers that wish to voluntarily
label their food product or ingredients
(for humans or animals) as either
1 See
57 FR 22984, May 29, 1992.
note that, if a different GE salmon is
developed in the future, we will separately assess
the data and information about that salmon to
determine whether it differs materially from non-GE
salmon and, as such, whether additional labeling
would be required on food derived from that
salmon.
3 Memorandum to File: Office of Nutrition,
Labeling and Dietary Supplements, CFSAN:
Evaluation of data and information and
recommendations related to the labeling of food
from AquAdvantage Salmon.
2 We
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containing or not containing products
from GE Atlantic salmon. FDA’s main
concern within the context of this
guidance is that any voluntary labeling
be truthful and not misleading.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (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.
This draft guidance contains proposed
collections of information. ‘‘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 publish a 60-day notice in the
Federal Register soliciting public
comment on each proposed collection of
information before submitting the
collection to OMB for approval. To
comply with this requirement, FDA will
publish a 60-day notice on the proposed
collections of information in this draft
guidance in a future issue of the Federal
Register.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at https://
www.fda.gov/FoodGuidances or https://
www.regulations.gov. Use the FDA Web
site listed in the previous sentence to
find the most current version of the
guidance.
Dated: November 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–29904 Filed 11–23–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2000–D–0075]
Voluntary Labeling Indicating Whether
Foods Have or Have Not Been Derived
From Genetically Engineered Plants;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a
guidance for industry entitled
‘‘Voluntary Labeling Indicating Whether
SUMMARY:
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Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Notices
Foods Have or Have Not Been Derived
from Genetically Engineered Plants.’’
The guidance is intended to help food
manufacturers that wish to voluntarily
label their plant-derived food products
or ingredients (for humans or for
animals) as having been made with or
without bioengineering.
DATES: Submit either electronic or
written comments on the guidance at
any time. Fax written comments on the
collection of information by December
24, 2015.
ADDRESSES: To ensure that comments on
the information collection are received,
the Office of Management and Budget
(OMB) recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–New and
title ‘‘Voluntary Labeling Indicating
Whether Foods Have or Have Not Been
Derived from Genetically Engineered
Plants.’’ Also include the FDA docket
number found in brackets in the
heading of this document.
You may submit comments as
follows:
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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:
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• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2000–D–0075 for ‘‘Voluntary Labeling
Indicating Whether Foods Have or Have
Not Been Derived from Genetically
Engineered Plants.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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
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73195
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of this guidance to the Office of
Nutrition, Labeling, and Dietary
Supplements (HFS–800), Center for
Food Safety and Applied Nutrition,
Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD
20740. Send two self-addressed
adhesive labels to assist that office in
processing your request. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT:
Regarding human food issues: Andrea
Krause, Center for Food Safety and
Applied Nutrition (HFS–820), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–2371. Regarding animal food
issues: Kathleen Jones, Center for
Veterinary Medicine (HFV–220), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 240–402–
7077. Regarding the information
collection: FDA PRA Staff, Office of
Operations, Food and Drug
Administration, 8455 Colesville Rd.,
COLE–14526, Silver Spring, MD 20993–
0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 403 of the Federal Food, Drug,
and Cosmetic Act (the 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
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’’ (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. This
technology has long been referred to as
‘‘rDNA technology,’’ ‘‘genetic
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engineering,’’ or ‘‘bioengineering,’’ and
more recently, as ‘‘modern
biotechnology.’’
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.
In the Federal Register of January 18,
2001 (66 FR 4839), we announced the
availability of a draft guidance for
industry entitled ‘‘Voluntary Labeling
Indicating Whether Foods Have or Have
Not Been Developed Using
Bioengineering.’’ We received more than
155,000 comments on the draft
guidance. Most comments were
submitted by consumers. Other
comments represented the views of
advocacy groups, trade organizations,
organic grocers/food co-ops, private
sector business, farming/farm bureaus,
food manufacturers, crop developers,
local governments, and academic
researchers. We have considered the
comments and revised the guidance as
appropriate. We understand that
consumers may want information about
whether or not a food is developed
through genetic engineering. Thus, we
are providing guidance on voluntary
labeling that will help manufacturers
that would like to provide consumers
with additional information about the
foods they consume.
We are issuing this guidance
consistent with our good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on this topic. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. In
addition, this guidance does not
preempt State food labeling
requirements that are consistent with
the Federal requirements described in
the guidance and that are not otherwise
expressly preempted by the FD&C Act.
II. Paperwork Reduction Act of 1995
This final guidance contains
information collection provisions that
are subject to review by OMB under the
Paperwork Reduction Act of 1995 (the
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PRA) (44 U.S.C. 3501–3520). Under the
PRA, Federal Agencies must obtain
approval from 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, in the Federal Register of
January 18, 2001, we gave interested
persons 60 days to comment on the
information collection provisions in the
draft guidance (66 FR 4839 at 4840).
After publishing the 60-day notice
requesting public comment, section
3507 of the PRA (44 U.S.C. 3507)
requires Federal Agencies to submit the
proposed collection to OMB for review
and clearance. In compliance with 44
U.S.C. 3507, we have submitted the
following proposed collection of
information to OMB for review and
clearance. FDA is issuing this final
guidance subject to OMB approval of
the collection of information. If the
collection is approved, FDA will
publish a notice in the Federal Register
concerning OMB approval and
providing an OMB control number.
Voluntary Labeling Indicating Whether
Foods Have or Have Not Been Derived
From Genetically Engineered Plants
OMB Control Number 0910–New
As noted, in the Federal Register of
January 18, 2001, we announced the
availability of the draft guidance
document and requested public
comment on the information collection
provisions. Subsequently, we published
a document in the Federal Register of
October 31, 2003 (68 FR 62086),
informing interested parties that the
proposed collection of information had
been submitted to the OMB for review
and clearance under the PRA. However,
we determined that the request for
comments was issued prematurely.
Thus, we withdrew the notice on
November 21, 2003 (68 FR 65717). We
are now reissuing the request for
comments and submitting the proposed
collection of information to OMB.
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
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(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
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 claiming that a product is
not developed using genetically
engineered 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.
As noted, in the Federal Register of
January 18, 2001, we published a 60-day
notice requesting public comment on
the proposed collection of information.
We received more than 155,000
comments, each containing one or more
issues. The following is a discussion of
the comments we received on the
information collection and our response
to those comments.
(Comment 1) Most comments agreed
that labeling food products as
genetically engineered or nongenetically engineered would result in
costs due to segregation, testing, or
third-party validation, in addition to
label changes. However, some
comments said the producers that
choose to label their products as nongenetically engineered and the
consumers that choose to purchase
these products should incur these costs.
Other comments said that these costs
should be borne by the growers,
manufacturers, processors, and
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marketers of genetically engineered
foods.
(Response) We disagree that it would
be necessary to incur costs due to
segregation, testing, or third-party
validation to substantiate a claim that a
food was not developed using genetic
engineering. We also note that the
question of who should bear the
paperwork burden is not within the
scope of the guidance.
(Comment 2) One comment stated
that we underestimated the number of
small firms that will choose to label
their product as not genetically
engineered, but will not attempt to make
an organic claim.
(Response) We disagree that we
underestimated the number of
respondents in the 2001 60-day Federal
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of foods that are labeled as not
genetically engineered.
(Comment 3) Numerous comments
pointed out that mandatory labeling
would have high costs for additional
activities such as segregation, testing,
labeling, quality control, and
certification. One comment estimated
that these costs could be as high as 6 to
17 percent of the farmgate price.
(Response) The paperwork reduction
analysis only estimates the paperwork
burden associated with voluntary
labeling. The estimates related to
mandatory labeling are outside the
scope of the guidance, and we have not
included them in the analysis.
FDA estimates the burden of this
collection of information as follows:
Register notice. The comment did not
offer any evidence to substantiate this
claim or give an estimate of how many
small firms will choose to make a nongenetically engineered claim. We based
our estimate of the number of firms that
would label their products with a
genetically engineered claim on the
number of products making an organic
claim and the number of products that
were not currently making an organic
claim on their label, but were making a
statement about genetic engineering on
their Web site, through a press release,
or other venue when the 2001 60-day
notice was published. We have,
however, updated in this notice the
estimated number of recordkeepers to
reflect new information on the number
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.
We have updated the number of
recordkeepers and respondents to reflect
new information on the number of food
products that are labeled using the
terms ‘‘biotechnology’’ and ‘‘GMO’’
(genetically modified organism) since
the 2001 issuance of the 60-day notice
and draft guidance. 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 revised estimates of the
recordkeeping burden (table 1 of this
document) on data from Labelbase by
FoodEssentials. Labelbase is a custom
online system for accessing a 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
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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 Web site 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’’
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
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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). In
the 2001 notice, we estimated $53,040
as ‘‘operating and maintenance costs’’
associated with this recordkeeping
burden. These costs were reported in
error and have been removed from table
1. We estimate no capital costs or
operating and maintenance costs
associated with this recordkeeping
burden.
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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.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at https://www.
fda.gov/FoodGuidances or https://
www.regulations.gov. Use the FDA Web
site listed in the previous sentence to
find the most current version of the
guidance.
Dated: November 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–29903 Filed 11–23–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
mstockstill on DSK4VPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, NIAID Investigator Initiated
Program Project Applications (P01).
Date: December 17, 2015.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Room
4H200 A/B, 5601 Fishers Lane, Rockville,
MD 20892, (Telephone Conference Call).
Contact Person: Kelly Y. Poe, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
Room 3F40B, National Institutes of Health,
NIAID, 5601 Fishers Lane, MSC 9823,
Bethesda, MD 20892–9823, (240) 669–5036,
poeky@mail.nih.gov.
VerDate Sep<11>2014
17:20 Nov 23, 2015
Jkt 238001
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
DEPARTMENT OF HOMELAND
SECURITY
Dated: November 18, 2015.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[USCG–2015–1005]
Coast Guard
Merchant Mariner Medical Advisory
Committee; Vacancies
Coast Guard, DHS.
Request for applications.
[FR Doc. 2015–29854 Filed 11–23–15; 8:45 am]
AGENCY:
BILLING CODE 4140–01–P
ACTION:
The Coast Guard seeks
applications for membership on the
Merchant Mariner Medical Advisory
Committee. The Merchant Mariner
Medical Advisory Committee provides
advice and recommendations to the
Secretary on matters related to medical
certification determinations for issuance
of licenses, certificates of registry, and
merchant mariners’ documents; medical
standards and guidelines for the
physical qualifications of operators of
commercial vessels; medical examiner
education; and medical research.
Applicants selected for service on the
Merchant Mariner Medical Advisory
Committee via this solicitation will not
begin their respective term until August
8, 2016.
DATES: Completed applications should
reach the Coast Guard on or before
January 25, 2016.
ADDRESSES: Applicants should send a
cover letter expressing interest in an
appointment to the Merchant Mariner
Medical Advisory Committee that also
identifies which membership category
the applicant is applying under, along
with a resume detailing the applicant’s
experience via one of the following
methods:
• By Email: ashley.e.holm@uscg.mil.
• By Fax: 202–372–4908.
• By Mail: Lieutenant Ashley Holm,
Alternate Designated Federal Officer of
the Merchant Mariner Medical Advisory
Committee, Commandant, Mariner
Credentialing Program Policy Division
(CG–CVC–4), U.S. Coast Guard, 2703
Martin Luther King Jr. Ave. SE., Stop
7501 Washington, DC 20593–7501.
FOR FURTHER INFORMATION CONTACT:
Lieutenant Ashley Holm, Alternate
Designated Federal Officer of the
Merchant Mariner Medical Advisory
Committee, Commandant, Mariner
Credentialing Program Policy Division
(CG–CVC–4), U.S. Coast Guard, 2703
Martin Luther King Jr. Ave. SE., Stop
7501 Washington, DC 20593–7501,
ashley.e.holm@uscg.mil, phone: 202–
372–1128, fax: 202–372–4908.
SUPPLEMENTARY INFORMATION: The
Merchant Mariner Medical Advisory
Committee was established under
Section 210 of the Coast Guard
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Physiology and Pathobiology of
Cardiovascular and Respiratory Systems.
Date: November 23–24, 2015.
Time: 8:00 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: The St. Regis Washington, DC, 923
16th St.NW., Washington, DC 20006.
Contact Person: Abdelouahab Aitouche,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4222,
MSC 7812, Bethesda, MD 20892, 301–435–
2365, aitouchea@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 18, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–29853 Filed 11–23–15; 8:45 am]
BILLING CODE 4140–01–P
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[Federal Register Volume 80, Number 226 (Tuesday, November 24, 2015)]
[Notices]
[Pages 73194-73198]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29903]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2000-D-0075]
Voluntary Labeling Indicating Whether Foods Have or Have Not Been
Derived From Genetically Engineered Plants; Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a guidance for industry entitled ``Voluntary Labeling
Indicating Whether
[[Page 73195]]
Foods Have or Have Not Been Derived from Genetically Engineered
Plants.'' The guidance is intended to help food manufacturers that wish
to voluntarily label their plant-derived food products or ingredients
(for humans or for animals) as having been made with or without
bioengineering.
DATES: Submit either electronic or written comments on the guidance at
any time. Fax written comments on the collection of information by
December 24, 2015.
ADDRESSES: To ensure that comments on the information collection are
received, the Office of Management and Budget (OMB) recommends that
written comments be faxed to the Office of Information and Regulatory
Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
oira_submission@omb.eop.gov. All comments should be identified with the
OMB control number 0910-New and title ``Voluntary Labeling Indicating
Whether Foods Have or Have Not Been Derived from Genetically Engineered
Plants.'' Also include the FDA docket number found in brackets in the
heading of this document.
You may submit comments as follows:
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2000-D-0075 for ``Voluntary Labeling Indicating Whether Foods Have
or Have Not Been Derived from Genetically Engineered Plants.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of this guidance to the
Office of Nutrition, Labeling, and Dietary Supplements (HFS-800),
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.
FOR FURTHER INFORMATION CONTACT: Regarding human food issues: Andrea
Krause, Center for Food Safety and Applied Nutrition (HFS-820), Food
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, 240-402-2371. Regarding animal food issues: Kathleen Jones,
Center for Veterinary Medicine (HFV-220), Food and Drug Administration,
7519 Standish Pl., Rockville, MD 20855, 240-402-7077. Regarding the
information collection: FDA PRA Staff, Office of Operations, Food and
Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD
20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 403 of the Federal Food, Drug, and Cosmetic Act (the 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 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'' (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.
This technology has long been referred to as ``rDNA technology,''
``genetic
[[Page 73196]]
engineering,'' or ``bioengineering,'' and more recently, as ``modern
biotechnology.''
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.
In the Federal Register of January 18, 2001 (66 FR 4839), we
announced the availability of a draft guidance for industry entitled
``Voluntary Labeling Indicating Whether Foods Have or Have Not Been
Developed Using Bioengineering.'' We received more than 155,000
comments on the draft guidance. Most comments were submitted by
consumers. Other comments represented the views of advocacy groups,
trade organizations, organic grocers/food co-ops, private sector
business, farming/farm bureaus, food manufacturers, crop developers,
local governments, and academic researchers. We have considered the
comments and revised the guidance as appropriate. We understand that
consumers may want information about whether or not a food is developed
through genetic engineering. Thus, we are providing guidance on
voluntary labeling that will help manufacturers that would like to
provide consumers with additional information about the foods they
consume.
We are issuing this guidance consistent with our good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on this topic. It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. In addition, this guidance does not preempt
State food labeling requirements that are consistent with the Federal
requirements described in the guidance and that are not otherwise
expressly preempted by the FD&C Act.
II. Paperwork Reduction Act of 1995
This final guidance contains information collection provisions that
are subject to review by 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 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, in the Federal Register of
January 18, 2001, we gave interested persons 60 days to comment on the
information collection provisions in the draft guidance (66 FR 4839 at
4840).
After publishing the 60-day notice requesting public comment,
section 3507 of the PRA (44 U.S.C. 3507) requires Federal Agencies to
submit the proposed collection to OMB for review and clearance. In
compliance with 44 U.S.C. 3507, we have submitted the following
proposed collection of information to OMB for review and clearance. FDA
is issuing this final guidance subject to OMB approval of the
collection of information. If the collection is approved, FDA will
publish a notice in the Federal Register concerning OMB approval and
providing an OMB control number.
Voluntary Labeling Indicating Whether Foods Have or Have Not Been
Derived From Genetically Engineered Plants
OMB Control Number 0910-New
As noted, in the Federal Register of January 18, 2001, we announced
the availability of the draft guidance document and requested public
comment on the information collection provisions. Subsequently, we
published a document in the Federal Register of October 31, 2003 (68 FR
62086), informing interested parties that the proposed collection of
information had been submitted to the OMB for review and clearance
under the PRA. However, we determined that the request for comments was
issued prematurely. Thus, we withdrew the notice on November 21, 2003
(68 FR 65717). We are now reissuing the request for comments and
submitting the proposed collection of information to OMB.
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 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 claiming that a
product is not developed using genetically engineered 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.
As noted, in the Federal Register of January 18, 2001, we published
a 60-day notice requesting public comment on the proposed collection of
information. We received more than 155,000 comments, each containing
one or more issues. The following is a discussion of the comments we
received on the information collection and our response to those
comments.
(Comment 1) Most comments agreed that labeling food products as
genetically engineered or non-genetically engineered would result in
costs due to segregation, testing, or third-party validation, in
addition to label changes. However, some comments said the producers
that choose to label their products as non-genetically engineered and
the consumers that choose to purchase these products should incur these
costs. Other comments said that these costs should be borne by the
growers, manufacturers, processors, and
[[Page 73197]]
marketers of genetically engineered foods.
(Response) We disagree that it would be necessary to incur costs
due to segregation, testing, or third-party validation to substantiate
a claim that a food was not developed using genetic engineering. We
also note that the question of who should bear the paperwork burden is
not within the scope of the guidance.
(Comment 2) One comment stated that we underestimated the number of
small firms that will choose to label their product as not genetically
engineered, but will not attempt to make an organic claim.
(Response) We disagree that we underestimated the number of
respondents in the 2001 60-day Federal Register notice. The comment did
not offer any evidence to substantiate this claim or give an estimate
of how many small firms will choose to make a non-genetically
engineered claim. We based our estimate of the number of firms that
would label their products with a genetically engineered claim on the
number of products making an organic claim and the number of products
that were not currently making an organic claim on their label, but
were making a statement about genetic engineering on their Web site,
through a press release, or other venue when the 2001 60-day notice was
published. We have, however, updated in this notice the estimated
number of recordkeepers to reflect new information on the number of
foods that are labeled as not genetically engineered.
(Comment 3) Numerous comments pointed out that mandatory labeling
would have high costs for additional activities such as segregation,
testing, labeling, quality control, and certification. One comment
estimated that these costs could be as high as 6 to 17 percent of the
farmgate price.
(Response) The paperwork reduction analysis only estimates the
paperwork burden associated with voluntary labeling. The estimates
related to mandatory labeling are outside the scope of the guidance,
and we have not included them in the analysis.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We have updated the number of recordkeepers and respondents to
reflect new information on the number of food products that are labeled
using the terms ``biotechnology'' and ``GMO'' (genetically modified
organism) since the 2001 issuance of the 60-day notice and draft
guidance. 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 revised estimates of the recordkeeping burden (table 1
of this document) on data from Labelbase by FoodEssentials. Labelbase
is a custom online system for accessing a 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 Web site 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'' 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). In the
2001 notice, we estimated $53,040 as ``operating and maintenance
costs'' associated with this recordkeeping burden. These costs were
reported in error and have been removed from table 1. We estimate no
capital costs or operating and maintenance costs associated with this
recordkeeping burden.
[[Page 73198]]
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 re-worded.
III. Electronic Access
Persons with access to the Internet may obtain the guidance at
https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the
FDA Web site listed in the previous sentence to find the most current
version of the guidance.
Dated: November 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29903 Filed 11-23-15; 8:45 am]
BILLING CODE 4164-01-P
