81 FR 52370 - Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition; Reopening of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 152 (August 8, 2016)

Page Range		52370-52371
FR Document		2016-18720

The Food and Drug Administration (FDA or we) is reopening the comment period for the notice of filing that appeared in the Federal Register of May 20, 2016 (81 FR 31877). In the notice, we requested comments on a filed food additive petition (FAP 6B4815), submitted by the Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science In The Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council, proposing that we amend and/or revoke specified regulations to no longer provide for the food contact use of specified ortho-phthalates. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

Federal Register, Volume 81 Issue 152 (Monday, August 8, 2016)

[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Proposed Rules]
[Pages 52370-52371]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-18720]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 175, 176, 177, and 178

[Docket No. FDA-2016-F-1253]

Breast Cancer Fund, Center for Environmental Health, Center for
Food Safety, Center for Science in the Public Interest, Clean Water
Action, Consumer Federation of America, Earthjustice, Environmental
Defense Fund, Improving Kids' Environment, Learning Disabilities
Association of America, and Natural Resources Defense Council; Filing
of Food Additive Petition; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is reopening the
comment period for the notice of filing that appeared in the Federal
Register of May 20, 2016 (81 FR 31877). In the notice, we requested
comments on a filed food additive petition (FAP 6B4815), submitted by
the Breast Cancer Fund, Center for Environmental Health, Center for
Food Safety, Center for Science In The Public Interest, Clean Water
Action, Consumer Federation of America, Earthjustice, Environmental
Defense Fund, Improving Kids' Environment, Learning Disabilities
Association of America, and Natural Resources Defense Council,
proposing that we amend and/or revoke specified regulations to no
longer provide for the food contact use of specified ortho-phthalates.
We are taking this action in response to a request for an extension to
allow interested persons additional time to submit comments.

DATES: FDA is reopening the comment period on the notice of filing of a
food additive petition published on May 20, 2016 (81 FR 31877). Submit
either electronic or written comments by September 19, 2016.

ADDRESSES: 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

[[Page 52371]]

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-2016-F-1253 for ``Breast Cancer Fund, Center for Environmental
Health, Center for Food Safety, Center for Science in the Public
Interest, Clean Water Action, Consumer Federation of America,
Earthjustice, Environmental Defense Fund, Improving Kids' Environment,
Learning Disabilities Association of America, and Natural Resources
Defense Council; Filing of Food Additive Petition.'' 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: Kelly Randolph, Center for Food Safety
and Applied Nutrition (HFS-265), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740-3835, 240-402-1188.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 20, 2016 (81
FR 31877), FDA published a notice of filing of a food additive petition
(FAP 6B4815) submitted by the Breast Cancer Fund, Center for
Environmental Health, Center for Food Safety, Center for Science in the
Public Interest, Clean Water Action, Consumer Federation of America,
Earthjustice, Environmental Defense Fund, Improving Kids' Environment,
Learning Disabilities Association of America, and Natural Resources
Defense Council, c/o Mr. Thomas Neltner, 1875 Connecticut Ave. NW.,
Suite 600, Washington, DC 20009. The notice invited comments on the
petition. The petition proposes that we amend and/or revoke specified
regulations to no longer provide for the food contact use of specified
ortho-phthalates. Specifically, the petitioners request that we
consider that ortho-phthalates are a class of chemically and
pharmacologically related substances, and state that there is no longer
a reasonable certainty of no harm for the food contact uses of the
specified ortho-phthalates. If we determine that new data are available
that justify amending the specified food additive regulations in 21 CFR
parts 175, 176, 177, and 178 so that they will no longer provide for
the use of the ortho-phthalates, we will publish such an amendment of
these regulations in the Federal Register, as set forth in Sec.
171.130 and Sec. 171.100 (21 CFR 171.100).
We have received a request for a 60-day extension of the comment
period for the petition. The request conveyed concern that the 60-day
comment period does not allow sufficient time to collect and provide
data and information and develop a meaningful and thoughtful response
to the assertions set forth in the petition.
FDA has considered the request; however, because the request was
submitted too late to allow us to extend the comment period, we are,
instead, reopening the comment period until September 19, 2016. We
believe that re-opening the comment period until that date allows
adequate time for interested persons to submit comments without
significantly delaying our review.

Dated: August 2, 2016.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2016-18720 Filed 8-5-16; 8:45 am]
BILLING CODE 4164-01-P

52370 Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Proposed Rules

Availability and Summary of Environmental Review DEPARTMENT OF HEALTH AND
Documents Proposed for Incorporation HUMAN SERVICES
by Reference This proposal will be subject to an
environmental analysis in accordance Food and Drug Administration
This document proposes to amend with FAA Order 1050.1F,
FAA Order 7400.9Z, Airspace ‘‘Environmental Impacts: Policies and 21 CFR Parts 175, 176, 177, and 178
Designations and Reporting Points, Procedures’’ prior to any FAA final
[Docket No. FDA–2016–F–1253]
dated August 6, 2015, and effective regulatory action.
September 15, 2015. FAA Order Breast Cancer Fund, Center for
List of Subjects in 14 CFR Part 71
7400.9Z is publicly available as listed in Environmental Health, Center for Food
the ADDRESSES section of this document. Airspace, Incorporation by reference, Safety, Center for Science in the Public
FAA Order 7400.9Z lists Class A, B, C, Navigation (air). Interest, Clean Water Action,
D, and E airspace areas, air traffic Consumer Federation of America,
service routes, and reporting points. The Proposed Amendment
Earthjustice, Environmental Defense
The Proposal Accordingly, pursuant to the Fund, Improving Kids’ Environment,
authority delegated to me, the Federal Learning Disabilities Association of
The FAA is proposing an amendment Aviation Administration proposes to America, and Natural Resources
to Title 14 Code of Federal Regulations amend 14 CFR part 71 as follows: Defense Council; Filing of Food
(14 CFR) Part 71 by modifying Class E Additive Petition; Reopening of
En route domestic airspace extending PART 71—DESIGNATION OF CLASS A, Comment Period
upward from 1,200 feet above the B, C, D, AND E AIRSPACE AREAS; AIR AGENCY: Food and Drug Administration,
surface in the vicinity of the Blue Mesa TRAFFIC SERVICE ROUTES; AND HHS.
VOR/DME, Blue Mesa, CO. One small REPORTING POINTS
Notice of petition; reopening of
ACTION:
airspace area northwest, near Montrose, comment period.
CO, and one small airspace area ■ 1. The authority citation for 14 CFR
southeast, near Trinidad, CO, both part 71 continues to read as follows: SUMMARY: The Food and Drug
excluded from the current boundary, Authority: 49 U.S.C. 106(f), 106(g), 40103, Administration (FDA or we) is
would be added for the safety and 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, reopening the comment period for the
management of IFR operations, 1959–1963 Comp., p. 389. notice of filing that appeared in the
specifically point-to-point, en route Federal Register of May 20, 2016 (81 FR
operations outside of the established § 71.1 [Amended] 31877). In the notice, we requested
airway structure, and Air Traffic Control ■ 2. The incorporation by reference in comments on a filed food additive
vectoring services. 14 CFR 71.1 of FAA Order 7400.9Z, petition (FAP 6B4815), submitted by the
Class E airspace designations are Airspace Designations and Reporting Breast Cancer Fund, Center for
published in paragraph 6006 of FAA Points, dated August 6, 2015, and Environmental Health, Center for Food
Order 7400.9Z, dated August 6, 2015, effective September 15, 2015, is Safety, Center for Science In The Public
and effective September 15, 2015, which amended as follows: Interest, Clean Water Action, Consumer
is incorporated by reference in 14 CFR Federation of America, Earthjustice,
71.1. The Class E airspace designations Paragraph 6006 En Route Domestic Environmental Defense Fund,
listed in this document will be Airspace Areas. Improving Kids’ Environment, Learning
published subsequently in the Order. * * * * * Disabilities Association of America, and
Natural Resources Defense Council,
Regulatory Notices and Analyses ANM CO E6 Blue Mesa, CO [Amended] proposing that we amend and/or revoke
Blue Mesa VOR/DME, CO specified regulations to no longer
The FAA has determined that this (Lat. 38°27′08″ N., long. 107°02′23″ W.) provide for the food contact use of
regulation only involves an established That airspace extending upward from specified ortho-phthalates. We are
body of technical regulations for which 1,200 feet above the surface within an area taking this action in response to a
frequent and routine amendments are bounded by Lat. 35°39′30″ N., long. request for an extension to allow
necessary to keep them operationally 107°25′27″ W.; to Lat. 36°14′38″ N., long. interested persons additional time to
current, is non-controversial and 107°40′25″ W.; to Lat. 37°16′00″ N., long. submit comments.
unlikely to result in adverse or negative 108°22′00″ W.; to Lat. 37°58′51″ N., long.
DATES: FDA is reopening the comment
comments. It, therefore: (1) Is not a 108°22′29″ W.; to Lat. 39°01′00″ N., long.
107°47′00″ W.; to Lat. 39°07′40″ N., long. period on the notice of filing of a food
‘‘significant regulatory action’’ under additive petition published on May 20,
107°13′47″ W.; to Lat. 39°11′48″ N., long.
Executive Order 12866; (2) is not a 2016 (81 FR 31877). Submit either
106°29′16″ W.; to Lat. 39°40′23″ N., long.
‘‘significant rule’’ under DOT 103°29′02″ W.; to Lat. 36°59′57″ N., long. electronic or written comments by
Regulatory Policies and Procedures (44 104°18′04″ W.; to Lat. 36°17′00″ N., long. September 19, 2016.
FR 11034; February 26, 1979); and (3) 104°14′00″ W.; to Lat. 36°12′53″ N., long. ADDRESSES: You may submit comments
does not warrant preparation of a 104°56′21″ W.; to Lat. 36°13′34″ N., long. as follows:
regulatory evaluation as the anticipated 105°54′42″ W.; thence to the point of
impact is so minimal. Since this is a beginning. Electronic Submissions
routine matter that will only affect air
ehiers on DSK5VPTVN1PROD with PROPOSALS

Submit electronic comments in the
traffic procedures and air navigation, it Issued in Seattle, Washington, on July 29, following way:
is certified that this rule, when 2016. • Federal eRulemaking Portal: http://
promulgated, would not have a Tracey Johnson, www.regulations.gov. Follow the
significant economic impact on a Manager, Operations Support Group, Western instructions for submitting comments.
substantial number of small entities Service Center. Comments submitted electronically,
under the criteria of the Regulatory [FR Doc. 2016–18676 Filed 8–5–16; 8:45 am] including attachments, to http://
Flexibility Act. BILLING CODE 4910–13–P www.regulations.gov will be posted to

VerDate Sep<11>2014 13:56 Aug 05, 2016 Jkt 238001 PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 E:\FR\FM\08AUP1.SGM 08AUP1

Document Created: 2016-08-06 03:08:31
Document Modified: 2016-08-06 03:08:31

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Notice of petition; reopening of comment period.
Dates		FDA is reopening the comment period on the notice of filing of a food additive petition published on May 20, 2016 (81 FR 31877). Submit either electronic or written comments by September 19, 2016.
Contact		Kelly Randolph, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1188.
FR Citation		81 FR 52370
CFR Citation		21 CFR 175 21 CFR 176 21 CFR 177 21 CFR 178

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 152 (August 8, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration