
[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)]
[Proposed Rules]
[Pages 65978-65979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27277]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2015-F-3663]


Grocery Manufacturers Association; Filing of Food Additive 
Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by the Grocery Manufacturers 
Association, proposing that the food additive regulations be amended to 
provide for the safe use of partially hydrogenated vegetable oils 
(PHOs) in various food applications.

DATES: This food additive petition was filed on October 1, 2015. Submit 
either electronic or written comments on the petitioner's environmental 
assessment by November 27, 2015.

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 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-2015-F-3663 for ``Grocery Manufacturers Association; 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: Ellen Anderson, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1309.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), we are giving notice 
that we have filed a food additive petition (FAP 5A4811), submitted by 
the Grocery Manufacturers Association, 1350 I Street, NW., Suite 300, 
Washington, DC 20005. The petition proposes to amend the food additive 
regulations in 21 CFR part 172 Food Additives Permitted for Direct 
Addition to Food for Human Consumption to provide for the safe use of 
PHOs in the following food applications at specified maximum use 
levels: As a carrier or component thereof for flavors or flavorings, as 
a diluent or component thereof for color additives, as an incidental 
additive or processing aid, and as a direct additive in specific foods.
    We are reviewing the potential environmental impact of this 
petition. To encourage public participation consistent with regulations 
issued under the National Environmental Policy Act (40 CFR 1501.4(b)), 
we are placing the environmental assessment submitted with the petition 
that is the subject of this notice on public display at the Division of 
Dockets Management (see DATES and ADDRESSES) for public review and 
comment.
    We will also place on public display, in the Division of Dockets 
Management and at http://www.regulations.gov, any amendments to, or 
comments on, the petitioner's environmental assessment without further 
announcement in the Federal Register. If, based on our review, we find 
that an environmental impact statement is not required, and this 
petition results in a regulation, we will publish the notice of 
availability of our finding of no significant impact and the evidence 
supporting that finding with the regulation in the Federal Register in 
accordance with 21 CFR 25.51(b).


[[Page 65979]]


    Dated: October 22, 2015.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 2015-27277 Filed 10-27-15; 8:45 am]
 BILLING CODE 4164-01-P


