80_FR_80966 80 FR 80718 - Use of the Term “Natural” in the Labeling of Human Food Products; Request for Information and Comments; Extension of Comment Period

80 FR 80718 - Use of the Term “Natural” in the Labeling of Human Food Products; Request for Information and Comments; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 248 (December 28, 2015)

Page Range80718-80719
FR Document2015-32471

The Food and Drug Administration (FDA or we) is extending the comment period for a docket to receive information and comments on the use of the term ``natural'' in the labeling of human food products, including foods that are genetically engineered or contain ingredients produced through the use of genetic engineering. A notice requesting comments on this topic appeared in the Federal Register of November 12, 2015. We initially established February 10, 2016, as the deadline for the submission of comments. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

Federal Register, Volume 80 Issue 248 (Monday, December 28, 2015) 
[Federal Register Volume 80, Number 248 (Monday, December 28, 2015)]
[Proposed Rules]
[Pages 80718-80719]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-32471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2014-N-1207]


Use of the Term ``Natural'' in the Labeling of Human Food 
Products; Request for Information and Comments; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for a docket to receive information and comments on the 
use of the term ``natural'' in the labeling of human food products, 
including foods that are genetically engineered or contain ingredients 
produced through the use of genetic engineering. A notice requesting 
comments on this topic appeared in the Federal Register of November 12, 
2015. We initially established February 10, 2016, as the deadline for 
the submission of comments. We are taking this action

[[Page 80719]]

in response to requests for an extension to allow interested persons 
additional time to submit comments.

DATES: FDA is extending the comment period for a docket to receive 
information and comments on the use of the term ``natural'' in the 
labeling of human food products. We established the docket in a notice 
published on November 12, 2015 (80 FR 69905). Submit either electronic 
or written comments to the docket by May 10, 2016.

ADDRESSES: You may submit comments by any of the following methods:

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-2014-N-1207 for ``Use of the Term `Natural' in the Labeling of 
Human Food Products; Request for Information and Comments.'' 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.

FOR FURTHER INFORMATION CONTACT: Margaret-Hannah Emerick, Center for 
Food Safety and Applied Nutrition (HFS-820), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-2371.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 12, 2015 
(80 FR 69905), we published a notice announcing the establishment of a 
docket to receive information and comments on the use of the term 
``natural'' in the labeling of human food products, including foods 
that are genetically engineered or contain ingredients produced through 
the use of genetic engineering. The notice discussed FDA's position 
regarding the use of the term ``natural'', the events that prompted us 
to establish a docket to request comment on this issue, and specific 
questions. We provided a 90-day comment period that was scheduled to 
end on February 10, 2016.
    We received requests for a 90-day extension of the comment period. 
The requests conveyed concern that the current 90-day comment period 
does not allow sufficient time to develop meaningful or thoughtful 
comments to the questions and issues we presented in the notice.
    FDA has considered the requests and is extending the comment period 
for 90 days, until May 10, 2016. We believe that a 90-day extension 
allows adequate time for interested persons to submit comments.

    Dated: December 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32471 Filed 12-24-15; 8:45 am]
 BILLING CODE 4164-01-P

80718 Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Proposed Rules (capped at a maximum base amount of maximum penalty applicable to the amount shall be the statutory maximum $250,000 per violation). violation. penalty applicable to the violation. iii. In an egregious case, if the iv. In an egregious case, if the The following matrix represents the apparent violation is disclosed through apparent violation comes to OEE’s base amount of the civil monetary a voluntary self-disclosure, the base attention by means other than a penalty for each category of violation: amount shall be one-half of the statutory voluntary self-disclosure, the base b. Adjustment for Applicable Relevant a single Charging Letter shall be enforcement cases are set forth in Factors considered as a single violation for § 766.18 of the EAR. purposes of this subsection. In those Dated: December 22, 2015. The base amount of the civil monetary cases where a prior Charging Letter or penalty may be adjusted to reflect David W. Mills, warning letter within the preceding five applicable Factors for Administrative Assistant Secretary for Export Enforcement. years involved conduct of a Action set forth in Section III of these [FR Doc. 2015–32606 Filed 12–24–15; 8:45 am] substantially different nature from the Guidelines. A Factor may result in a BILLING CODE 3510–33–P apparent violation at issue, OEE may lower or higher penalty amount consider the apparent violation at issue depending upon whether it is a ‘‘first violation.’’ In determining the aggravating or mitigating or otherwise DEPARTMENT OF HEALTH AND extent of any mitigation for a first relevant to the circumstances at hand. HUMAN SERVICES violation, OEE may consider any prior Mitigating factors may be combined for enforcement action taken with respect a greater reduction in penalty, but Food and Drug Administration to the Respondent, including any mitigation will generally not exceed 75 warning letters issued, or any civil percent of the base penalty. Subject to 21 CFR Part 101 monetary settlements entered into with this limitation, as a general matter, in BIS. When an acquiring firm takes [Docket No. FDA–2014–N–1207] those cases where the following reasonable steps to uncover, correct, and Mitigating Factors are present, BIS will disclose or cause to be disclosed to OEE Use of the Term ‘‘Natural’’ in the adjust the base penalty amount in the conduct that gave rise to violations by Labeling of Human Food Products; following manner: an acquired business before the Request for Information and In cases involving exceptional acquisition, OEE typically will not take Comments; Extension of Comment cooperation with OEE as set forth in such violations into account as an Period Mitigating Factor G, but no voluntary aggravating factor in settling other self-disclosure as defined in § 764.5 of AGENCY: Food and Drug Administration, violations by the acquiring firm. the EAR, the base penalty amount HHS. generally will be reduced between 25 iii. In cases involving charges pertaining to transactions where a ACTION: Notice; extension of comment and 40 percent. Exceptional cooperation period. in cases involving voluntary self- license would likely have been disclosure may also be considered as a approved had one been sought as set SUMMARY: The Food and Drug further mitigating factor. forth in Mitigating Factor H, the base Administration (FDA or we) is In cases involving a Respondent’s first penalty amount generally will be extending the comment period for a violation, the base penalty amount reduced by up to 25 percent. docket to receive information and generally will be reduced by up to 25 In all cases, the penalty amount will comments on the use of the term percent. An apparent violation generally not exceed the applicable statutory ‘‘natural’’ in the labeling of human food will be considered a ‘‘first violation’’ if maximum. Similarly, while mitigating products, including foods that are mstockstill on DSK4VPTVN1PROD with PROPOSALS the Respondent has not been convicted factors may be combined for a greater genetically engineered or contain of an export-related criminal violation reduction in penalty, mitigation will ingredients produced through the use of or been subject to a BIS final order in generally not exceed 75 percent of the genetic engineering. A notice requesting five years, or a warning letter in three base penalty. comments on this topic appeared in the years, preceding the date of the C. Settlement Procedures Federal Register of November 12, 2015. transaction giving rise to the apparent We initially established February 10, violation. A group of substantially The procedures relating to the 2016, as the deadline for the submission EP28DE15.020</GPH> similar apparent violations addressed in settlement of administrative of comments. We are taking this action VerDate Sep<11>2014 13:06 Dec 24, 2015 Jkt 238001 PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 E:\FR\FM\28DEP1.SGM 28DEP1

Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Proposed Rules 80719 in response to requests for an extension Products; Request for Information and docket to receive information and to allow interested persons additional Comments.’’ Received comments will be comments on the use of the term time to submit comments. placed in the docket and, except for ‘‘natural’’ in the labeling of human food DATES: FDA is extending the comment those submitted as ‘‘Confidential products, including foods that are period for a docket to receive Submissions,’’ publicly viewable at genetically engineered or contain information and comments on the use of http://www.regulations.gov or at the ingredients produced through the use of the term ‘‘natural’’ in the labeling of Division of Dockets Management genetic engineering. The notice human food products. We established between 9 a.m. and 4 p.m., Monday discussed FDA’s position regarding the the docket in a notice published on through Friday. use of the term ‘‘natural’’, the events November 12, 2015 (80 FR 69905). • Confidential Submissions—To that prompted us to establish a docket Submit either electronic or written submit a comment with confidential to request comment on this issue, and comments to the docket by May 10, information that you do not wish to be specific questions. We provided a 90- 2016. made publicly available, submit your day comment period that was scheduled comments only as a written/paper to end on February 10, 2016. ADDRESSES: You may submit comments submission. You should submit two We received requests for a 90-day by any of the following methods: copies total. One copy will include the extension of the comment period. The Electronic Submissions information you claim to be confidential requests conveyed concern that the with a heading or cover note that states current 90-day comment period does Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS not allow sufficient time to develop following way: CONFIDENTIAL INFORMATION.’’ The meaningful or thoughtful comments to • Federal eRulemaking Portal: http:// Agency will review this copy, including the questions and issues we presented www.regulations.gov. Follow the the claimed confidential information, in in the notice. instructions for submitting comments. its consideration of comments. The FDA has considered the requests and Comments submitted electronically, second copy, which will have the is extending the comment period for 90 including attachments, to http:// claimed confidential information days, until May 10, 2016. We believe www.regulations.gov will be posted to redacted/blacked out, will be available that a 90-day extension allows adequate the docket unchanged. Because your for public viewing and posted on time for interested persons to submit comment will be made public, you are http://www.regulations.gov. Submit comments. solely responsible for ensuring that your both copies to the Division of Dockets Dated: December 21, 2015. comment does not include any Management. If you do not wish your confidential information that you or a Leslie Kux, name and contact information to be third party may not wish to be posted, Associate Commissioner for Policy. made publicly available, you can such as medical information, your or [FR Doc. 2015–32471 Filed 12–24–15; 8:45 am] provide this information on the cover anyone else’s Social Security number, or BILLING CODE 4164–01–P sheet and not in the body of your confidential business information, such comments and you must identify this as a manufacturing process. Please note information as ‘‘confidential.’’ Any that if you include your name, contact ENVIRONMENTAL PROTECTION information marked as ‘‘confidential’’ information, or other information that AGENCY will not be disclosed except in identifies you in the body of your accordance with 21 CFR 10.20 and other comments, that information will be 40 CFR Part 52 applicable disclosure law. For more posted on http://www.regulations.gov. • If you want to submit a comment information about FDA’s posting of [EPA–R05–OAR–2015–0074; FRL–9940–58– with confidential information that you comments to public dockets, see 80 FR Region 5] do not wish to be made available to the 56469, September 18, 2015, or access the information at: http://www.fda.gov/ Air Plan Approval; Indiana; Temporary public, submit the comment as a Alternate Opacity Limits for American written/paper submission and in the regulatoryinformation/dockets/ default.htm. Electric Power, Rockport manner detailed (see ‘‘Written/Paper Docket: For access to the docket to AGENCY: Environmental Protection Submissions’’ and ‘‘Instructions’’). read background documents or the Agency (EPA). Written/Paper Submissions electronic and written/paper comments ACTION: Proposed rule. Submit written/paper submissions as received, go to http:// follows: www.regulations.gov and insert the SUMMARY: The Environmental Protection • Mail/Hand delivery/Courier (for docket number, found in brackets in the Agency (EPA) is proposing to approve a written/paper submissions): Division of heading of this document, into the revision to the Indiana State Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts Implementation Plan (SIP), authorizing and Drug Administration, 5630 Fishers and/or go to the Division of Dockets temporary alternate opacity limits Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, rm. (TAOLs) at the American Electric • For written/paper comments 1061, Rockville, MD 20852. Power, Rockport (AEP Rockport) facility submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT: during periods of unit startup and Management, FDA will post your Margaret-Hannah Emerick, Center for shutdown. This action is consistent comment, as well as any attachments, Food Safety and Applied Nutrition with the Clean Air Act (CAA) and EPA mstockstill on DSK4VPTVN1PROD with PROPOSALS except for information submitted, (HFS–820), Food and Drug policy regarding emissions during marked and identified, as confidential, Administration, 5100 Paint Branch periods of startup and shutdown. if submitted as detailed in Pkwy., College Park, MD 20740, 240– Indiana has provided an air quality ‘‘Instructions.’’ 402–2371. analysis demonstrating that this revision Instructions: All submissions received SUPPLEMENTARY INFORMATION: In the will continue to protect the applicable must include the Docket No. FDA– Federal Register of November 12, 2015 National Ambient Air Quality Standards 2014–N–1207 for ‘‘Use of the Term (80 FR 69905), we published a notice (NAAQS) for fine particulate matter ‘Natural’ in the Labeling of Human Food announcing the establishment of a (PM2.5) in Spencer County. VerDate Sep<11>2014 13:06 Dec 24, 2015 Jkt 238001 PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 E:\FR\FM\28DEP1.SGM 28DEP1


Document Created: 2018-03-02 09:24:19
Document Modified: 2018-03-02 09:24:19
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotice; extension of comment period.
DatesFDA is extending the comment period for a docket to receive information and comments on the use of the term ``natural'' in the labeling of human food products. We established the docket in a notice published on November 12, 2015 (80 FR 69905). Submit either electronic or written comments to the docket by May 10, 2016.
ContactMargaret-Hannah Emerick, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240- 402-2371.
FR Citation80 FR 80718 
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