
[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]


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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.

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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: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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

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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 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

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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 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\
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                                                                                        Number of                       Average  burden
                             Activity                                  Number of       records per      Total annual          per          Total hours
                                                                     recordkeepers     recordkeeper       records        recordkeeping
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Recordkeeping per the Guidance....................................              85                4              340                 1              340
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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.

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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 re-worded.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
http://www.fda.gov/FoodGuidances or http://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


