Document ID: FDA-2016-F-1253-0379
Agency: fda
Document Type: Proposed Rule
Title: 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
Posted Date: 2016-08-08T04:00Z

[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Proposed Rules]
[Pages 52370-52371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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