[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)]
[Notices]
[Pages 17556-17557]
[FR Doc No: 2018-08252]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1176]

Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical
Ingredients: Questions and Answers; International Council for
Harmonisation; 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 Agency) is announcing
the availability of a final guidance for industry entitled ``Q7 Good
Manufacturing Practice Guidance for Active Pharmaceutical Ingredients:
Questions and Answers.'' The guidance was prepared under the auspices
of the International Council for Harmonisation (ICH), formerly the
International Conference on Harmonisation. This question and answer
(Q&A) guidance addresses questions about implementation of FDA's
guidance ``Q7 Good Manufacturing Practice Guidance for Active
Pharmaceutical Ingredients'' (ICH Q7). The Q&A guidance is intended to
clarify uncertainties due to the interpretation of certain sections of
ICH Q7 and to help ensure that all active pharmaceutical ingredients
(APIs) meet the standards for quality and purity they purport or are
represented to possess.

DATES: The announcement of the guidance is published in the Federal
Register on April 20, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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): 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-D-1176 for ``Q7 Good Manufacturing Practice Guidance for
Active Pharmaceutical Ingredients: Questions and Answers; International
Council for Harmonisation; Guidance for Industry; Availability.''
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 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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Alicia Mozzachio, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3308, Silver Spring, MD 20993-0002, 301-
796-3206; or Anna Flynn, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
5070, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    Regarding the ICH: Amanda Roache, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 1176, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, regulatory authorities and industry associations
from around the world have participated in many important initiatives
to promote international harmonization of regulatory requirements under
ICH. FDA has participated in several ICH meetings designed to enhance
harmonization, and FDA is committed to seeking scientifically based
harmonized technical procedures for pharmaceutical development. One of
the goals of harmonization is to identify and reduce differences in
technical requirements for drug development among regulatory agencies.
    ICH was established to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. FDA also seeks input from consumer
representatives and others. ICH is concerned with harmonization of
technical requirements for the registration of pharmaceutical products
for human use among regulators around the world. The six founding
members of ICH are the European Commission; the European Federation of
Pharmaceutical Industries Associations; FDA; the Japanese Ministry of
Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers
Association; and the Pharmaceutical Research and Manufacturers of
America. The Standing Members of the ICH Association also include
Health Canada and Swissmedic. Any party eligible as a Member in
accordance with the ICH Articles of Association can apply for
membership in writing to the ICH Secretariat. The ICH Secretariat,
which coordinates the preparation of documentation, operates as an
international nonprofit organization and is funded by the Members of
the ICH Association.
    The ICH Assembly is the overarching body of the Association and
includes representatives from each ICH member and observer. The
Assembly is responsible for the endorsement of draft guidelines and
adoption of final guidelines. FDA publishes ICH guidelines as FDA
guidance.
    A final draft of the guidance was submitted to the ICH Assembly and
endorsed by the regulatory agencies in June 2015. The guidance provides
clarification on the implementation of good manufacturing practices for
APIs, as described in ICH Q7.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Q7 Good Manufacturing Practice Guidance
for Active Pharmaceutical Ingredients: Questions and Answers.'' 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. This guidance
is not subject to Executive Order 12866.

II. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: April 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-08252 Filed 4-19-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 226 (Tuesday, November 24, 2015)]
[Notices]
[Pages 73194-73198]
[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

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:<PHONE_NUMBER>, or emailed to
<EMAIL_ADDRESS>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,<PHONE_NUMBER>. Regarding animal food issues: Kathleen Jones,
Center for Veterinary Medicine (HFV-220), Food and Drug Administration,
7519 Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>. Regarding the
information collection: FDA PRA Staff, Office of Operations, Food and
Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD
20993-0002<EMAIL_ADDRESS>
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

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

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.

    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


[Federal Register Volume 82, Number 181 (Wednesday, September 20, 2017)]
[Notices]
[Pages 43964-43965]
[FR Doc No: 2017-20046]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0026; FRL-9968-03]

Compliance Date Extension; Statutory Requirements for
Substantiation of Confidential Business Information (CBI) Claims Under
the Toxic Substances Control Act (TSCA)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: EPA is extending the compliance dates published in the Federal
Register on January 19, 2017 and previously extended in the Federal
Register on February 21, 2017. Specifically, the Agency set September
19, 2017 as the deadline by which submitters of TSCA submissions
containing information claimed as CBI and filed between June 22, 2016
and March 21, 2017 had to submit to EPA the substantiation required by
TSCA section 14(c)(3) for all information claimed as confidential,
other than information exempt from substantiation pursuant to TSCA
section 14(c)(2). The

Agency is now giving submitters until October 19, 2017 to provide the
substantiations to EPA.

DATES: For TSCA submissions containing information claimed as CBI that
was filed between June 22, 2016 and March 21, 2017, submitters have
until October 19, 2017 to provide the required substantiation.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2017-0026, is available at
http://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Scott Sherlock, Attorney Advisor, Environmental Assistance Division,
Office of Pollution Prevention and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001;
telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    This announcement is directed to the public in general. It may,
however, be of particular interest to you if you manufacture (defined
by statute to include import) and/or process chemicals covered by TSCA
(15 U.S.C. 2601 et seq.). This may include businesses identified by the
North American Industrial Classification System (NAICS) codes 325 and
32411. Because this action is directed to the general public and other
entities may also be interested, the Agency has not attempted to
describe all the specific entities that may be interested in this
action. If you have any questions regarding the applicability of this
action to a particular entity, consult the technical person listed
under FOR FURTHER INFORMATION CONTACT.

II. What action is the agency taking?

    EPA is extending the compliance dates published in the Federal
Register on January 19, 2017, and previously extended in the Federal
Register on February 21, 2017. Specifically, the Agency is now giving
those submitters until October 19, 2017, to submit the substantiations
required by TSCA section 14(c)(3). This extension is in response to
concerns raised by industry stakeholders regarding the ability for
companies to meet the previous September 19, 2017, deadline due to
recent severe weather events. EPA is providing this additional
flexibility for stakeholders because of the impacts of hurricanes
Harvey and Irma.
    For more detail on the requirements of TSCA section 14(c)(3) and
how to comply with those requirements, see the Federal Register on
January 19, 2017 (82 FR 6522) (FRL-9958-34) and the Federal Register on
February 21, 2017 (82 FR 11218) (FRL-9959-39).

III. What is the agency's authority for taking this action?

    EPA has determined that TSCA section 14(c)(3), 15 U.S.C.
2613(c)(3), requires an affected business to substantiate all TSCA CBI
claims, except for information subject to TSCA section 14(c)(2), at the
time the affected business submits the claimed information to EPA.
    TSCA section 14(c)(1)(a) requires an affected business to assert a
claim for protection from disclosure concurrent with submission of the
information in accordance with existing or future rules. TSCA section
14(c)(3) in turn requires an affected business submitting a claim to
protect information from disclosure to substantiate the claim, also in
accordance with existing or future rules.
    Because EPA published its interpretation that TSCA section 14(c)(3)
requires up front substantiation after some companies had already
asserted confidentiality claims subject to TSCA section 14(c)(3), the
Agency set a future deadline for submission of substantiations
pertaining to those submissions. This notice extends that deadline.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: September 14, 2017.
Nancy B. Beck,
Deputy Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2017-20046 Filed 9-15-17; 4:15 pm]
 BILLING CODE 6560-50-P