81_FR_31975 81 FR 31877 - 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

81 FR 31877 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 98 (May 20, 2016)

Page Range31877-31879
FR Document2016-11866

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.

Federal Register, Volume 81 Issue 98 (Friday, May 20, 2016) 
[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Proposed Rules]
[Pages 31877-31879]
From the Federal Register Online  [www.thefederalregister.org]
[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

Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Proposed Rules 31877 (ii) For the final results of an used to prepare the brief. Briefs in DEPARTMENT OF HEALTH AND administrative review, new shipper excess of the word limitation shall be HUMAN SERVICES review, changed circumstances review, rejected and shall be considered or section 762 review, 30 days after the untimely. Challenges to opposing Food and Drug Administration date of publication of the preliminary party’s word count must be filed with results of review, unless the Secretary the agency within 48 hours of the filing 21 CFR Parts 175, 176, 177, and 178 alters the time limit; or of the case or reply brief and [Docket No. FDA–2016–F–1253] (iii) For the final results of an accompanying certifications or the expedited sunset review, expedited Breast Cancer Fund, Center for challenge will not be considered. If a antidumping or countervailing duty Environmental Health, Center for Food person has designated an agent to review, Article 8 violation review, Safety, Center for Science in the Public Article 4/Article 7 review, or section receive service that is located outside the United States, and served briefs by Interest, Clean Water Action, 753 review, a date specified by the Consumer Federation of America, Secretary. first class airmail in accordance with 19 CFR 351.303(f)(3)(i), the agency will Earthjustice, Environmental Defense (2) The case brief must present all Fund, Improving Kids’ Environment, arguments that continue in the consider on a case-by-case basis the time allowed to that person to challenge Learning Disabilities Association of submitter’s view to be relevant to the America, and Natural Resources Secretary’s final determination or final a party’s word count. Defense Council; Filing of Food results, including any arguments (f) Comments on adequacy of Additive Petition presented before the date of publication response and appropriateness of of the preliminary determination or expedited sunset review—(1) In general. AGENCY: Food and Drug Administration, preliminary results. As part of the case Where the Secretary determines that HHS. brief, parties are encouraged to provide ACTION: Notice of petition. respondent interested parties provided a summary of the arguments not to inadequate response to a notice of exceed five pages and a table of statutes, SUMMARY: The Food and Drug regulations, and cases cited. initiation (see § 351.218(e)(1)(ii)) and Administration (FDA or we) is (d) Rebuttal brief. (1) Any interested has notified the International Trade announcing that we have filed a party or U.S. Government agency may Commission as such under petition, submitted by Breast Cancer submit a ‘‘rebuttal brief’’ within five § 351.218(e)(1)(ii)(C), interested parties Fund, Center for Environmental Health, days after the time limit for filing the (and industrial users and consumer Center for Food Safety, Center for case brief, unless the Secretary alters organizations) that submitted a Science in the Public Interest, Clean this time limit. complete substantive response to the Water Action, Consumer Federation of (2) The rebuttal brief may respond notice of initiation under § 351.218(d)(3) America, Earthjustice, Environmental only to arguments raised in case briefs may file comments on whether an Defense Fund, Improving Kids’ and should identify the arguments to expedited sunset review under section Environment, Learning Disabilities which it is responding. As part of the 751(c)(3)(B) of the Act and Association of America, and Natural rebuttal brief, parties are encouraged to § 351.218(e)(1)(ii)(B) or (C) is Resources Defense Council proposing provide a summary of the arguments not appropriate based on the adequacy of that we amend and/or revoke specified to exceed five pages and a table of responses to the notice of initiation. regulations to no longer provide for the statutes, regulations, and cases cited. These comments may not include any food contact use of specified ortho- (e) Word limits. (1) Except with the phthalates. new factual information or evidence consent of Enforcement & Compliance for good cause, each party shall use no (such as supplementation of a DATES: The food additive petition was more than 25,000 words total between substantive response to the notice of filed on April 12, 2016. Submit either its case and rebuttal briefs. The initiation) and are limited to five pages. electronic or written comments by July allocation of the 25,000 words between (2) Time limit for filing comments. 19, 2016. case and rebuttal briefs is left to each Comments on adequacy of response and ADDRESSES: You may submit comments party. All attachments to such briefs, appropriateness of expedited sunset as follows: headings, footnotes, endnotes, and review must be filed not later than 70 Electronic Submissions quotations shall be included in the word days after the date publication in the limitation. The summary of arguments Federal Register of the notice of Submit electronic comments in the and the table of statutes, regulations and initiation. following way: cases cited referenced in paragraphs • Federal eRulemaking Portal: http:// [FR Doc. 2016–11864 Filed 5–19–16; 8:45 am] (c)(2) and (d)(2) of this section shall not www.regulations.gov. Follow the BILLING CODE 3510–DS–P be included in the word limitation. instructions for submitting comments. (2) The case brief, if any, shall contain Comments submitted electronically, a certification by the party or its including attachments, to http:// representative indicating the number of www.regulations.gov will be posted to words in the brief and the number of the docket unchanged. Because your words available for the rebuttal brief. comment will be made public, you are The rebuttal brief, if any, shall contain solely responsible for ensuring that your mstockstill on DSK3G9T082PROD with PROPOSALS a certification by the party or its comment does not include any representative indicating the number of confidential information that you or a words in the brief and certifying that the third party may not wish to be posted, total word limit of 25,000 has not been such as medical information, your or exceeded in the party’s combined case anyone else’s Social Security number, or and rebuttal brief word limit. The party confidential business information, such filing the certification may rely on the as a manufacturing process. Please note word count of the software program that if you include your name, contact VerDate Sep<11>2014 17:17 May 19, 2016 Jkt 238001 PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 E:\FR\FM\20MYP1.SGM 20MYP1

31878 Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Proposed Rules information, or other information that name and contact information to be file these portions of the submission as identifies you in the body of your made publicly available, you can a food additive petition. comments, that information will be provide this information on the cover II. Amendment of 21 CFR Parts 175, posted on http://www.regulations.gov. sheet and not in the body of your • If you want to submit a comment 176, 177, and 178 comments and you must identify this with confidential information that you information as ‘‘confidential.’’ Any In accordance with the procedures for do not wish to be made available to the information marked as ‘‘confidential’’ amending or revoking a food additive public, submit the comment as a will not be disclosed except in regulation in § 171.130 (21 CFR written/paper submission and in the accordance with 21 CFR 10.20 and other 171.130), the petition asks us to amend manner detailed (see ‘‘Written/Paper applicable disclosure law. For more parts 175, 176, 177, and 178 to no longer Submissions’’ and ‘‘Instructions’’). information about FDA’s posting of provide for the food contact use of comments to public dockets, see 80 FR certain specified ortho-phthalates. The Written/Paper Submissions 56469, September 18, 2015, or access specified ortho-phthalates and Submit written/paper submissions as the information at: http://www.fda.gov/ corresponding regulations in parts 175, follows: regulatoryinformation/dockets/ 176, 177, and 178 are as follows: • Mail/Hand delivery/Courier (for default.htm. § 175.105 Adhesives written/paper submissions): Division of Dockets Management (HFA–305), Food Docket: For access to the docket to Butyl benzyl phthalate (CAS No. 85– and Drug Administration, 5630 Fishers read background documents or the 68–7), Butyldecyl phthalate (CAS No. Lane, Rm. 1061, Rockville, MD 20852. electronic and written/paper comments 89–19–0), Butyloctyl phthalate (CAS • For written/paper comments received, go to http:// No. 84–78–6), Butyl phthalate butyl submitted to the Division of Dockets www.regulations.gov and insert the glycolate (CAS No. 85–70–1), Management, FDA will post your docket number, found in brackets in the Di(butoxyethyl) phthalate (CAS No.117– comment, as well as any attachments, heading of this document, into the 83–9), Dibutyl phthalate (CAS No. 84– except for information submitted, ‘‘Search’’ box and follow the prompts 74–2), Dicyclohexyl phthalate (CAS No. marked and identified, as confidential, and/or go to the Division of Dockets 84–61–7), Di(2- if submitted as detailed in Management, 5630 Fishers Lane, Rm. ethylhexyl)hexahydrophthalate, Di(2- ‘‘Instructions.’’ 1061, Rockville, MD 20852. ethylhexyl)phthalate (CAS No. 117–81– Instructions: All submissions received FOR FURTHER INFORMATION CONTACT: 7), Diethyl phthalate (CAS No. 84–66– must include the Docket No. FDA– Kelly Randolph, Center for Food Safety 2), Dihexyl phthalate (CAS No. 84–75– 2016–F–1253 for ‘‘Breast Cancer Fund, and Applied Nutrition (HFS–275), Food 3), Dihydroabietylphthalate (CAS No. Center for Environmental Health, Center and Drug Administration, 5100 Paint 26760–71–4), Diisobutyl phthalate (CAS for Food Safety, Center for Science In Branch Pkwy., College Park, MD 20740– No. 84–69–5), Diisodecyl phthalate The Public Interest, Clean Water Action, 3835, 240–402–1188. (CAS No. 26761–40–0), Diisooctyl Consumer Federation of America, phthalate (CAS No. 27554–26–3), Earthjustice, Environmental Defense SUPPLEMENTARY INFORMATION: Dimethyl phthalate (CAS No. 131–11– Fund, Improving Kids’ Environment, I. Background 3), Dioctyl phthalate (CAS No. 117–84– Learning Disabilities Association of 0), Diphenyl phthalate (CAS No. 84–62– America, and Natural Resources Defense Under section 409(b)(5) of the Federal 8), Ethyl phthalyl ethyl glycolate (CAS Council; Filing of Food Additive Food, Drug, and Cosmetic Act (the No. 84–72–0), Methyl phthalyl ethyl Petition.’’ Received comments will be FD&C Act) (21 U.S.C. 348(b)(5)), we are glycolate (CAS No. 85–71–2), placed in the docket and, except for giving notice that we have filed a food Octyldecyl phthalate (CAS No. 119–07– those submitted as ‘‘Confidential additive petition (FAP 6B4815), 3), and Diallyl phthalate (CAS No. 131– Submissions,’’ publicly viewable at submitted by Breast Cancer Fund, 17–9). http://www.regulations.gov or at the Center for Science in the Public Interest, Division of Dockets Management Center for Environmental Health, Center § 175.300 Resinous and Polymeric between 9 a.m. and 4 p.m., Monday for Food Safety, Clean Water Action, Coatings through Friday. Consumer Federation of America, Dibutyl phthalate (CAS No. 84–74–2), • Confidential Submissions—To Earthjustice, Environmental Defense Diethyl phthalate (CAS No. 84–66–2), submit a comment with confidential Fund, Improving Kids’ Environment, Diisooctyl phthalate (CAS No. 27554– information that you do not wish to be Learning Disabilities Association of 26–3), Di(2-ethylhexyl) phthalate (CAS made publicly available, submit your America, and Natural Resources Defense No. 117–81–7), and Diisodecyl comments only as a written/paper Council, c/o Mr. Thomas Neltner, 1875 phthalate (CAS No. 26761–40–0). submission. You should submit two Connecticut Ave. NW., Suite 600, copies total. One copy will include the Washington, DC 20009. The submission § 175.320 Resinous and Polymeric information you claim to be confidential proposes that we amend and/or revoke Coatings for Polyolefin Films with a heading or cover note that states specified food additive regulations Butyl phthalyl butyl glycolate (CAS ‘‘THIS DOCUMENT CONTAINS under 21 CFR parts 175, 176, 177, and No. 85–70–1), Diethyl phthalate (CAS CONFIDENTIAL INFORMATION.’’ The 178 to no longer provide for the food No. 84–66–2), and Ethyl phthalyl ethyl Agency will review this copy, including contact use of specified ortho- glycolate (CAS No. 84–72–0). the claimed confidential information, in phthalates. We have filed this portion of mstockstill on DSK3G9T082PROD with PROPOSALS its consideration of comments. The the submission as a food additive § 176.170 Components of Paper and second copy, which will have the petition. The submission also requests Paperboard in Contact With Aqueous claimed confidential information that we amend our regulations in 21 and Fatty Foods redacted/blacked out, will be available CFR part 181 related to prior-sanctioned Butylbenzyl phthalate (CAS No. 85– for public viewing and posted on http:// uses of specified ortho-phthalates and 68–7), Dibutyl phthalate (CAS No. 84– www.regulations.gov. Submit both issue a new regulation in 21 CFR part 74–2), Dicyclohexyl phthalate (CAS No. copies to the Division of Dockets 189 prohibiting the use of eight specific 84–61–7), and Diallyl phthalate (CAS Management. If you do not wish your ortho-phthalates. We have declined to No. 131–17–9). VerDate Sep<11>2014 17:17 May 19, 2016 Jkt 238001 PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 E:\FR\FM\20MYP1.SGM 20MYP1

Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Proposed Rules 31879 § 176.180 Components of Paper and § 178.3740 Plasticizers in Polymeric 74–2), Butyl benzyl phthalate (CAS No. Paperboard in Contact With Dry Food Substances 85–68–7), Dicyclohexyl phthalate (CAS Butyl benzyl phthalate (CAS No. 85– Butylbenzyl phthalate (CAS No. 85– No. 84–61–7), Di-n-hexyl phthalate 68–7) and Diallyl phthalate (CAS No. 68–7), Dicyclohexyl phthalate (CAS No. (CAS No. 84–75–3), Diisooctyl phthalate 131–17–9). 84–61–7), Diisononyl phthalate (CAS (CAS No. 27554–26–3), Di(2-ethylhexyl) No. 28553–12–0), Dihexyl phthalate phthalate (CAS No. 117–81–7), and § 176.210 Defoaming Agents Used in (CAS No. 84–75–3), and Diphenyl Diisononyl phthalate (CAS No. 28553– the Manufacture of Paper and phthalate (CAS No. 84–62–8). 12–0). The submission requests that Paperboard FDA take this action by issuing a new § 178.3910 Surface Lubricants Used in Di(2-ethylhexyl) phthalate (CAS No. regulation in part 189. FDA has not filed the Manufacture of Metallic Articles 117–81–7). as part of the food additive petition the Diisodecyl phthalate (CAS No. 26761– request to issue the proposed regulation § 176.300 Slimicides 40–0), Di(2-ethylhexyl) phthalate (CAS in part 189. Such a request is not within Dibutyl phthalate (CAS No. 84–74–2), No. 117–81–7), and Diethyl phthalate the scope of a food additive petition Didecyl phthalate (CAS No. 84–77–5), (CAS No. 84–66–2). The petitioners request FDA to under section 409(b) of the FD&C Act and Dodecyl phthalate (CAS No. 21577– consider that ortho-phthalates are a (‘‘a petition proposing the issuance of a 80–0). class of chemically and regulation prescribing the conditions § 177.1010 Acrylic and Modified pharmacologically related substances, under which such [food] additive may Acrylic Plastics, Semirigid and Rigid and state that there is no longer a be safety used’’). We have informed Di(2-ethylhexyl) phthalate (CAS No. reasonable certainty of no harm for the petitioners that they may submit a 117–81–7) and Dimethyl phthalate (CAS food contact uses of the specified ortho- citizen petition under 21 CFR 10.30 No. 131–11–3). phthalates. If we determine that new requesting that FDA take this action. data are available that justify amending We also are reviewing the potential § 177.1200 Cellophane the specified food additive regulations environmental impact of the petitioners’ Castor oil phthalate with adipic acid in parts 175, 176, 177, and 178 so that requested action. The petitioners have and fumaric acid diethylene glycol they will no longer provide for the use claimed a categorical exclusion from polyester (CAS No. 68650–73–7), Castor of the ortho-phthalates, we will publish preparing an environmental assessment oil phthalate, hydrogentated (FDA No. such an amendment of these regulations in the Federal Register, as set forth in or environmental impact statement 977037–59–4), Dibutylphthalate (CAS No. 84–74–2), Dicyclohexyl phthalate § 171.130 and § 171.100 (21 CFR under 21 CFR 25.32(m). In accordance (CAS No. 84–61–7), Di(2-ethylhexy) 171.100). with regulations promulgated under the phthalate (CAS No. 117–81–7), National Environmental Policy Act (40 III. Amendment of 21 CFR 181.27 CFR 1506.6(b)), we are placing the Diisobutyl phthalate (CAS No. 84–69– 5), and Dimethylcyclohexyl phthalate A portion of the submission relates to environmental document submitted (CAS No. 1322–94–7). uses of five ortho-phthalates that are with the subject petition on public listed in § 181.27 as prior-sanctioned. display at the Division of Dockets § 177.1210 Closures With Sealing Those five ortho-phthalates are as Management (see ADDRESSES) so that Gaskets for Food Containers follows: Diethyl phthalate (CAS No. 84– interested persons may review the Diisodecyl phthalate (CAS No. 26761– 66–2), Ethyl phthalyl ethyl glycolate document. If we determine that the 40–0). (CAS No. 84–72–0), Butyl phthalyl butyl petitioners’ claim of categorical glycolate (CAS No. 85–70–1), Diisooctyl exclusion is warranted and that neither § 177.1460 Melamine-Formaldehyde phthalate (CAS No. 27554–26–3), and Resins in Molded Articles an environmental assessment nor Di(2-ethylhexyl) phthalate (CAS No. environmental impact statement is Dioctyl phthalate (CAS No. 117–84– 117–81–7). FDA has not filed as part of required, we will announce our 0). the food additive petition the request to determination in the Federal Register if revoke these prior sanctions. Section § 177.1590 Polyester Elastomers 201(s) of the FD&C Act exempts prior- this petition results in an amended Dimethyl orthophthalate (CAS No. sanctioned materials from the definition regulation(s). If we determine that the 131–11–3). of a food additive (21 U.S.C. 321(s)). claim of categorical exclusion is not Therefore, the request to revoke the warranted we will place the § 177.2420 Polyester Resins, Cross- prior-sanction for these substances is environmental assessment on public Linked not within the scope of a food additive display at the Division of Dockets Butyl benzyl phthalate (CAS No. 85– petition under section 409(b) of the Management and provide notice in the 68–7), Dibutyl phthalate (CAS No. 84– FD&C Act (‘‘a petition proposing the Federal Register announcing its 74–2), and Dimethyl phthalate (CAS No. issuance of a regulation prescribing the availability for review and comment. 131–11–3). conditions under which such [food] Dated: May 13, 2016. § 177.2600 Rubber Articles Intended additive may be safety used’’). We have Dennis M. Keefe, for Repeated Use informed petitioners that they may submit a citizen petition under 21 CFR Director, Office of Food Additive Safety, Diphenylguanidine phthalate (CAS 10.30 requesting that FDA take this Center for Food Additive Safety and Applied mstockstill on DSK3G9T082PROD with PROPOSALS No. 17573–13–6), Amyl decyl phthalate Nutrition. action. (CAS No. 7493–81–4), Dibutyl phthalate [FR Doc. 2016–11866 Filed 5–19–16; 8:45 am] (CAS No. 84–74–2), Didecyl phthalate IV. New Regulation in 21 CFR Part 189 BILLING CODE 4164–01–P (CAS No. 84–77–5), Diisodecyl A portion of the submission requests phthalate (CAS No. 26761–40–0), that FDA prohibit the food contact use Dioctyl phthalate (CAS No. 117–84–0), of the following eight ortho-phthalates: and Octyl decyl phthalate (CAS No. Diisobutyl phthalate (CAS No. 84–69– 119–07–3). 5), Di-n-butyl phthalate (CAS No. 84– VerDate Sep<11>2014 17:17 May 19, 2016 Jkt 238001 PO 00000 Frm 00012 Fmt 4702 Sfmt 9990 E:\FR\FM\20MYP1.SGM 20MYP1


Document Created: 2016-05-20 02:00:23
Document Modified: 2016-05-20 02:00:23
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 of petition.
DatesThe food additive petition was filed on April 12, 2016. Submit either electronic or written comments by July 19, 2016.
ContactKelly 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.
FR Citation81 FR 31877 
CFR Citation21 CFR 175
21 CFR 176
21 CFR 177
21 CFR 178
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