Document ID: FDA-2016-F-1253-0002
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
Posted Date: 2016-05-20T04:00Z

[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Proposed Rules]
[Pages 31877-31879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11866]

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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

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 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.

DATES: The food additive petition was filed on April 12, 2016. Submit 
either electronic or written comments by July 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 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

[[Page 31878]]

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-275), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1188.

SUPPLEMENTARY INFORMATION:

I. Background

    Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 348(b)(5)), we are giving notice that we have 
filed a food additive petition (FAP 6B4815), submitted by Breast Cancer 
Fund, Center for Science in the Public Interest, Center for 
Environmental Health, Center for Food Safety, 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 
submission proposes that we amend and/or revoke specified food additive 
regulations under 21 CFR parts 175, 176, 177, and 178 to no longer 
provide for the food contact use of specified ortho-phthalates. We have 
filed this portion of the submission as a food additive petition. The 
submission also requests that we amend our regulations in 21 CFR part 
181 related to prior-sanctioned uses of specified ortho-phthalates and 
issue a new regulation in 21 CFR part 189 prohibiting the use of eight 
specific ortho-phthalates. We have declined to file these portions of 
the submission as a food additive petition.

II. Amendment of 21 CFR Parts 175, 176, 177, and 178

    In accordance with the procedures for amending or revoking a food 
additive regulation in Sec.  171.130 (21 CFR 171.130), the petition 
asks us to amend parts 175, 176, 177, and 178 to no longer provide for 
the food contact use of certain specified ortho-phthalates. The 
specified ortho-phthalates and corresponding regulations in parts 175, 
176, 177, and 178 are as follows:

Sec.  175.105 Adhesives

    Butyl benzyl phthalate (CAS No. 85-68-7), Butyldecyl phthalate (CAS 
No. 89-19-0), Butyloctyl phthalate (CAS No. 84-78-6), Butyl phthalate 
butyl glycolate (CAS No. 85-70-1), Di(butoxyethyl) phthalate (CAS 
No.117-83-9), Dibutyl phthalate (CAS No. 84-74-2), Dicyclohexyl 
phthalate (CAS No. 84-61-7), Di(2-ethylhexyl)hexahydrophthalate, Di(2-
ethylhexyl)phthalate (CAS No. 117-81-7), Diethyl phthalate (CAS No. 84-
66-2), Dihexyl phthalate (CAS No. 84-75-3), Dihydroabietylphthalate 
(CAS No. 26760-71-4), Diisobutyl phthalate (CAS No. 84-69-5), 
Diisodecyl phthalate (CAS No. 26761-40-0), Diisooctyl phthalate (CAS 
No. 27554-26-3), Dimethyl phthalate (CAS No. 131-11-3), Dioctyl 
phthalate (CAS No. 117-84-0), Diphenyl phthalate (CAS No. 84-62-8), 
Ethyl phthalyl ethyl glycolate (CAS No. 84-72-0), Methyl phthalyl ethyl 
glycolate (CAS No. 85-71-2), Octyldecyl phthalate (CAS No. 119-07-3), 
and Diallyl phthalate (CAS No. 131-17-9).

Sec.  175.300 Resinous and Polymeric Coatings

    Dibutyl phthalate (CAS No. 84-74-2), Diethyl phthalate (CAS No. 84-
66-2), Diisooctyl phthalate (CAS No. 27554-26-3), Di(2-ethylhexyl) 
phthalate (CAS No. 117-81-7), and Diisodecyl phthalate (CAS No. 26761-
40-0).

Sec.  175.320 Resinous and Polymeric Coatings for Polyolefin Films

    Butyl phthalyl butyl glycolate (CAS No. 85-70-1), Diethyl phthalate 
(CAS No. 84-66-2), and Ethyl phthalyl ethyl glycolate (CAS No. 84-72-
0).

Sec.  176.170 Components of Paper and Paperboard in Contact With 
Aqueous and Fatty Foods

    Butylbenzyl phthalate (CAS No. 85-68-7), Dibutyl phthalate (CAS No. 
84-74-2), Dicyclohexyl phthalate (CAS No. 84-61-7), and Diallyl 
phthalate (CAS No. 131-17-9).

[[Page 31879]]

Sec.  176.180 Components of Paper and Paperboard in Contact With Dry 
Food

    Butyl benzyl phthalate (CAS No. 85-68-7) and Diallyl phthalate (CAS 
No. 131-17-9).

Sec.  176.210 Defoaming Agents Used in the Manufacture of Paper and 
Paperboard

    Di(2-ethylhexyl) phthalate (CAS No. 117-81-7).

Sec.  176.300 Slimicides

    Dibutyl phthalate (CAS No. 84-74-2), Didecyl phthalate (CAS No. 84-
77-5), and Dodecyl phthalate (CAS No. 21577-80-0).

Sec.  177.1010 Acrylic and Modified Acrylic Plastics, Semirigid and 
Rigid

    Di(2-ethylhexyl) phthalate (CAS No. 117-81-7) and Dimethyl 
phthalate (CAS No. 131-11-3).

Sec.  177.1200 Cellophane

    Castor oil phthalate with adipic acid and fumaric acid diethylene 
glycol polyester (CAS No. 68650-73-7), Castor oil phthalate, 
hydrogentated (FDA No. 977037-59-4), Dibutylphthalate (CAS No. 84-74-
2), Dicyclohexyl phthalate (CAS No. 84-61-7), Di(2-ethylhexy) phthalate 
(CAS No. 117-81-7), Diisobutyl phthalate (CAS No. 84-69-5), and 
Dimethylcyclohexyl phthalate (CAS No. 1322-94-7).

Sec.  177.1210 Closures With Sealing Gaskets for Food Containers

    Diisodecyl phthalate (CAS No. 26761-40-0).

Sec.  177.1460 Melamine-Formaldehyde Resins in Molded Articles

    Dioctyl phthalate (CAS No. 117-84-0).

Sec.  177.1590 Polyester Elastomers

    Dimethyl orthophthalate (CAS No. 131-11-3).

Sec.  177.2420 Polyester Resins, Cross-Linked

    Butyl benzyl phthalate (CAS No. 85-68-7), Dibutyl phthalate (CAS 
No. 84-74-2), and Dimethyl phthalate (CAS No. 131-11-3).

Sec.  177.2600 Rubber Articles Intended for Repeated Use

    Diphenylguanidine phthalate (CAS No. 17573-13-6), Amyl decyl 
phthalate (CAS No. 7493-81-4), Dibutyl phthalate (CAS No. 84-74-2), 
Didecyl phthalate (CAS No. 84-77-5), Diisodecyl phthalate (CAS No. 
26761-40-0), Dioctyl phthalate (CAS No. 117-84-0), and Octyl decyl 
phthalate (CAS No. 119-07-3).

Sec.  178.3740 Plasticizers in Polymeric Substances

    Butylbenzyl phthalate (CAS No. 85-68-7), Dicyclohexyl phthalate 
(CAS No. 84-61-7), Diisononyl phthalate (CAS No. 28553-12-0), Dihexyl 
phthalate (CAS No. 84-75-3), and Diphenyl phthalate (CAS No. 84-62-8).

Sec.  178.3910 Surface Lubricants Used in the Manufacture of Metallic 
Articles

    Diisodecyl phthalate (CAS No. 26761-40-0), Di(2-ethylhexyl) 
phthalate (CAS No. 117-81-7), and Diethyl phthalate (CAS No. 84-66-2).
    The petitioners request FDA to 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 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).

III. Amendment of 21 CFR 181.27

    A portion of the submission relates to uses of five ortho-
phthalates that are listed in Sec.  181.27 as prior-sanctioned. Those 
five ortho-phthalates are as follows: Diethyl phthalate (CAS No. 84-66-
2), Ethyl phthalyl ethyl glycolate (CAS No. 84-72-0), Butyl phthalyl 
butyl glycolate (CAS No. 85-70-1), Diisooctyl phthalate (CAS No. 27554-
26-3), and Di(2-ethylhexyl) phthalate (CAS No. 117-81-7). FDA has not 
filed as part of the food additive petition the request to revoke these 
prior sanctions. Section 201(s) of the FD&C Act exempts prior-
sanctioned materials from the definition of a food additive (21 U.S.C. 
321(s)). Therefore, the request to revoke the prior-sanction for these 
substances is not within the scope of a food additive petition under 
section 409(b) of the FD&C Act (``a petition proposing the issuance of 
a regulation prescribing the conditions under which such [food] 
additive may be safety used''). We have informed petitioners that they 
may submit a citizen petition under 21 CFR 10.30 requesting that FDA 
take this action.

IV. New Regulation in 21 CFR Part 189

    A portion of the submission requests that FDA prohibit the food 
contact use of the following eight ortho-phthalates: Diisobutyl 
phthalate (CAS No. 84-69-5), Di-n-butyl phthalate (CAS No. 84-74-2), 
Butyl benzyl phthalate (CAS No. 85-68-7), Dicyclohexyl phthalate (CAS 
No. 84-61-7), Di-n-hexyl phthalate (CAS No. 84-75-3), Diisooctyl 
phthalate (CAS No. 27554-26-3), Di(2-ethylhexyl) phthalate (CAS No. 
117-81-7), and Diisononyl phthalate (CAS No. 28553-12-0). The 
submission requests that FDA take this action by issuing a new 
regulation in part 189. FDA has not filed as part of the food additive 
petition the request to issue the proposed regulation in part 189. Such 
a request is not within the scope of a food additive petition under 
section 409(b) of the FD&C Act (``a petition proposing the issuance of 
a regulation prescribing the conditions under which such [food] 
additive may be safety used''). We have informed petitioners that they 
may submit a citizen petition under 21 CFR 10.30 requesting that FDA 
take this action.
    We also are reviewing the potential environmental impact of the 
petitioners' requested action. The petitioners have claimed a 
categorical exclusion from preparing an environmental assessment or 
environmental impact statement under 21 CFR 25.32(m). In accordance 
with regulations promulgated under the National Environmental Policy 
Act (40 CFR 1506.6(b)), we are placing the environmental document 
submitted with the subject petition on public display at the Division 
of Dockets Management (see ADDRESSES) so that interested persons may 
review the document. If we determine that the petitioners' claim of 
categorical exclusion is warranted and that neither an environmental 
assessment nor environmental impact statement is required, we will 
announce our determination in the Federal Register if this petition 
results in an amended regulation(s). If we determine that the claim of 
categorical exclusion is not warranted we will place the environmental 
assessment on public display at the Division of Dockets Management and 
provide notice in the Federal Register announcing its availability for 
review and comment.

    Dated: May 13, 2016.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Additive 
Safety and Applied Nutrition.
[FR Doc. 2016-11866 Filed 5-19-16; 8:45 am]
 BILLING CODE 4164-01-P