[Federal Register Volume 81, Number 1 (Monday, January 4, 2016)]
[Rules and Regulations]
[Pages 5-8]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-33026]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 176

[Docket No. FDA-2015-F-0714]


Indirect Food Additives: Paper and Paperboard Components

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
food additive regulations to no longer provide for the use of three 
specific perfluoroalkyl ethyl containing food-contact substances (FCSs) 
as oil and water repellants for paper and paperboard for use in contact 
with aqueous and fatty foods because new data are available as to the 
toxicity of substances structurally similar to these compounds that 
demonstrate there is no longer a reasonable certainty of no harm from 
the food-contact use of these FCSs. This action is in response to a 
petition filed by the Natural Resources Defense Council, the Center for 
Food Safety, the Breast Cancer Fund, the Center for Environmental 
Health, Clean Water Action, the Center for Science in the Public 
Interest, Children's Environmental Health Network, Environmental 
Working Group, and Improving Kids' Environment.

DATES: This rule is effective January 4, 2016. Submit either electronic 
or written objections and requests for a hearing by February 3, 2016. 
See section VIII for further information on the filing of objections.

ADDRESSES: You may submit objections and requests for a hearing as 
follows:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Objections submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your objection will be 
made public, you are solely responsible for ensuring that your 
objection 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 objection, that information will be 
posted on http://www.regulations.gov.
     If you want to submit an objection with confidential 
information that you do not wish to be made available to the public, 
submit the objection as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions in the following way:
     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 objections submitted to the Division of 
Dockets Management, FDA will post your objection, 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-

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2015-F-0714 for ``Indirect Food Additives: Paper and Paperboard 
Components.'' Received objections 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 an objection with 
confidential information that you do not wish to be made publicly 
available, submit your objections 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: Paul Honigfort, Center for Food Safety 
and Applied Nutrition (HFS-275), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1206.

SUPPLEMENTARY INFORMATION: 

I. Background

    In a notice published in the Federal Register on March 16, 2015 (80 
FR 13508), we announced that we filed a food additive petition (FAP 
4B4809) submitted by the Natural Resources Defense Council, 1152 15th 
St. NW., Suite 300, Washington, DC 20005; the Center for Food Safety, 
303 Sacramento St., Second Floor, San Francisco, CA 94111; Clean Water 
Action, 1444 Eye St. NW., Suite 400, Washington, DC 20005; the Center 
for Science in the Public Interest, 1220 L St. NW., Suite 300, 
Washington, DC 20005; Children's Environmental Health Network, 110 
Maryland Ave. NE., Suite 404, Washington, DC 20002; the Breast Cancer 
Fund, 1388 Sutter St., Suite 400, San Francisco, CA 94109-5400; the 
Center for Environmental Health, 2201 Broadway, Suite 302, Oakland, CA 
94612; Environmental Working Group, 1436 U St. NW., Suite 100, 
Washington, DC 20009; and Improving Kids' Environment, 1915 West 18th 
St., Indianapolis, IN 46202.
    The petition proposed to amend Sec.  176.170 (21 CFR 176.170) to no 
longer provide for the use of three perfluoroalkyl ethyl containing 
FCSs as oil and water repellants for paper and paperboard for use in 
contact with aqueous and fatty foods. The three FCSs which are the 
subjects of this petition are as follows:

    1. Diethanolamine salts of mono- and bis (1H,1H,2H,2H 
perfluoroalkyl) phosphates where the alkyl group is even-numbered in 
the range C8-C18 and the salts have a fluorine content of 52.4 
percent to 54.4 percent as determined on a solids basis;
    2. Pentanoic acid, 4,4-bis [(gamma-omega-perfluoro-C8-20-
alkyl)thio] derivatives, compounds with diethanolamine (CAS Reg. No. 
71608-61-2); and
    3. Perfluoroalkyl substituted phosphate ester acids, ammonium 
salts formed by the reaction of 2,2-bis[([gamma], [omega]-perfluoro 
C4-20 alkylthio) methyl]-1,3-propanediol, polyphosphoric acid and 
ammonium hydroxide.

II. Evaluation of Safety

    The three subject FCSs are regulated as food additives under the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act). Section 409 of the 
FD&C Act (21 U.S.C. 348) sets forth the statutory requirements for food 
additives. Section 201(s) of the FD&C Act (21 U.S.C. 321(s)) includes 
substances intended for use in producing, manufacturing, packing, 
processing, preparing, treating, packaging, transporting, or holding 
food among the substances defined as food additives, provided the 
intended use results or may reasonably be expected to result in it 
becoming a component of food and those uses were not sanctioned prior 
to 1958 or are not generally recognized as safe among experts qualified 
by scientific training and experience to evaluate its safety.
    Under section 402(a)(2)(c)(1) of the FD&C Act (21 U.S.C. 
342(a)(2)(c)(1)), food shall be deemed to be adulterated if it is or if 
it bears or contains any food additive that is unsafe within the 
meaning of section 409 of the FD&C Act. A food additive shall be deemed 
to be unsafe under section 409 of the FD&C Act, in relevant part, 
unless its use conforms to a food additive regulation or an effective 
food contact notification. Section 409(i) of the FD&C Act states that 
the procedure for amending or repealing a regulation shall conform to 
the procedure for the promulgation of such regulations. FDA's 
regulations specific to the administrative actions for food additives 
provide that the Commissioner, either on his own initiative or on the 
petition of any interested person, may propose the issuance of a 
regulation amending or repealing a regulation pertaining to a food 
additive (Sec.  171.130(a) (21 CFR 171.130(a)). These regulations 
further provide that any such petition must include an assertion of 
facts, supported by data, showing that new information exists with 
respect to the food additive or that new uses have been developed or 
old uses abandoned, that new data are available as to toxicity of the 
chemical, or that experience with the existing regulation or exemption 
may justify its amendment or appeal. New data must be furnished in the 
form specified in Sec.  171.1 (21 CFR 171.1) and 21 CFR 171.100 for 
submitting petitions (see Sec.  171.130(b)). Under these regulations, a 
petitioner may propose that we amend a food additive regulation if the 
petitioner can demonstrate that new data are available as to the 
toxicity of the food additive that may justify amendment of the food 
additive regulation.
    Under section 409(c)(3) of the FD&C Act we will not establish a 
regulation for the use of a food additive if a fair evaluation of the 
data fails to establish that the proposed use of the food additive, 
under the conditions of use to be specified in the regulation, will be 
safe. Our regulations, at 21 CFR 170.3(h)(i), define safety as ``a 
reasonable certainty in the minds of competent scientists that the 
substance is not harmful under the intended conditions of use.'' In 
order for FDA to grant a petition that seeks an amendment to a food 
additive regulation based upon new data concerning the toxicity of the 
food additive, such data must be adequate for FDA to conclude that 
there is no longer

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a reasonable certainty of no harm for the intended use of the 
substance.
    The petition asserts that publically available information on long-
chain perfluorinated compounds as a chemical class, which has become 
available after the food contact use of the three FCSs was approved, 
demonstrates that there is no longer a reasonable certainty of no harm 
from the food contact use of the three FCSs as listed in Sec.  176.170.
    All three of the FCSs subject to the petition contain extended 
alkyl chains where all of the hydrogens are replaced by fluorine (hence 
the FCSs are ``perfluorinated''). The toxicological profile of extended 
perfluorinated alkyl chains varies with chain length: On a general 
basis, those with extended perfluorinated alkyl chains greater than or 
equal to eight carbons in length demonstrate biopersistence in chronic 
feeding studies, while those with extended perfluorinated alkyl chains 
less than eight carbons in length do not (Ref. 1). Biopersistence is 
defined as persistence and accumulation of a material in a biological 
tissue due to preferential deposition of the material in the tissue 
combined with resistance of the material to removal from the tissue by 
natural clearance mechanisms (Ref. 2). As such, compounds containing 
extended perfluorinated alkyl chains are often classified as long- 
(i.e., >= eight carbons in length) or short-chain perfluorinated 
compounds, with implications for toxicology analysis including 
consideration of biopersistence. All three of the FCSs contain extended 
perfluorinated alkyl chains >= eight carbons in length and as such are 
long-chain perfluorinated compounds (PFCs).
    The petition cites a 2010 FDA comprehensive review memorandum on 
the available literature for long-chain PFCs (Ref. 3). This memorandum 
noted that available data on long-chain perfluorocarboxylic acids and 
fluorotelomer alcohols, both of which are subsets of long-chain PFCs, 
demonstrate reproductive and developmental toxicity in animal models. 
The FDA memorandum determined that, based on structural similarity to 
long-chain perfluorocarboxylic acids and fluorotelomer alcohols, and in 
the absence of contradictory data, data demonstrating reproductive and 
developmental toxicity for long-chain perfluorocarboxylic acids and 
fluorotelomer alcohols was applicable to long-chain PFCs on a general 
basis. The petition asserts that, as the three subject FCSs are long-
chain PFCs, the concern for reproductive and developmental toxicity for 
long-chain PFCs as determined in FDA's 2010 comprehensive review 
memorandum is applicable to these three FCSs. The petition also 
provides the results of an updated comprehensive literature search, 
which the petition asserts reinforces the concern for reproductive and 
developmental toxicity for long-chain PFCs. The petition also asserts 
that the updated literature search did not discover any information 
which would contradict FDA's 2010 determination that data demonstrating 
reproductive and developmental toxicity for long-chain 
perfluorocarboxylic acids and fluorotelomer alcohols was applicable to 
long-chain PFCs on a general basis.
    Upon review of the available information, FDA has confirmed our 
2010 determination that data demonstrating reproductive and 
developmental toxicity for long-chain perfluorocarboxylic acids and 
fluorotelomer alcohols are applicable to long-chain PFCs on a general 
basis (Ref. 4). FDA's updated review noted that there are no available 
toxicological studies conducted with the three FCSs that address the 
endpoints of reproductive or developmental toxicity. As all three FCSs 
are long-chain PFCs, and in the absence of data specific to the three 
FCSs to address these endpoints, FDA utilized the available data 
demonstrating reproductive and developmental toxicity for long-chain 
perfluorocarboxylic acids and fluorotelomer alcohols to assess the 
safety of the approved food-contact use of the FCSs. FDA's updated 
review noted deficiencies in the available information used to 
determine migration of the FCSs into food as a result of their approved 
food-contact use (Ref. 5). For this reason FDA was unable to calculate 
consumer exposure to the FCSs in a manner which would allow a 
quantitative assessment of the safety of that exposure in the context 
of the available data demonstrating reproductive and developmental 
toxicity for long-chain perfluorocarboxylic acids and fluorotelomer 
alcohols. However, FDA's review noted that available data demonstrate 
that long-chain perfluorocarboxylic acids and fluorotelomer alcohols 
biopersist in animals and that this biopersistence also occurs in 
humans (Ref. 4). Although available migration information does not 
allow a quantitative assessment of the safety of exposure to these 
FCSs, the reproductive and development toxicity of the three FCSs can 
be qualitatively assessed in the context of biopersistence and the 
expectation that chronic dietary exposure to these FCSs would result in 
a systemic exposure to the FCSs or their metabolic by-products at 
levels higher than their daily dietary exposure (Ref. 4).

III. Comments on the Filing Notice

    We received very few comments on the petition. These comments 
stated that the use of the three FCSs as listed in Sec.  176.170 has 
been abandoned.
    The basis for the action requested in the petition is that new data 
are available as to the toxicity of substances structurally similar to 
the subject FCSs that justify amending Sec.  176.170. The petition is 
not based on abandonment of the approved food contact use of these 
three FCSs. We have made a determination that the information provided 
in the petition and other publicly available relevant data demonstrates 
that there is no longer a reasonable certainty of no harm for the food 
contact use of the three FCS.

IV. Conclusion

    We reviewed the data and information in the petition and other 
available relevant material to evaluate whether new data are available 
as to the toxicity of the subject FCSs that justify amendment of Sec.  
176.170. As a result of this review, we concluded that data for subsets 
of long-chain PFCs (demonstrating biopersistence and reproductive and 
developmental toxicity) are applicable to long-chain PFCs on a general 
basis and that this data raises significant questions as to the safety 
of the authorized uses of the three FCSs subject to the petition (Ref. 
4). We also concluded that there is a lack of data specific to the 
three subject FCSs subject to the petition to address these questions 
(Ref. 4). For these reasons, in the absence of data specific to the 
three FCSs to address reproductive and developmental toxicity, adequate 
migration data to determine dietary exposure to the FCSs from the food-
contact use, and sufficient data to account for a consumer's systemic 
exposure resulting from chronic dietary exposure to these FCSs, we 
conclude that there is no longer a reasonable certainty of no harm for 
the food contact use of these FCSs. Therefore, we are amending part 176 
as set forth in this document. Upon the effective date (see DATES), 
these food additive uses are no longer authorized.

V. Public Disclosure

    In accordance with Sec.  171.1(h), the petition and the documents 
that we considered and relied upon in reaching our decision to approve 
the petition will

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be made available for public disclosure (see FOR FURTHER INFORMATION 
CONTACT). As provided in Sec.  171.1(h), we will delete from the 
documents any materials that are not available for public disclosure.

VI. Environmental Impact

    We have considered the environmental effects of this rule. As 
stated in the March 16, 2015, Federal Register notice of petition for 
FAP 4B4809 (80 FR 13508), we have determined, under 21 CFR 25.15(c), 
that this action ``is of a type that does not individually or 
cumulatively have a significant effect on the human environment'' such 
that neither an environmental assessment nor an environmental impact 
statement is required, as set forth in 21 CFR 25.32(m). We have not 
received any new information or comments that would affect our previous 
determination.

VII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VIII. Objections

    If you will be adversely affected by one or more provisions of this 
regulation, you may file with the Division of Dockets Management (see 
ADDRESSES) either electronic or written objections. You must separately 
number each objection, and within each numbered objection you must 
specify, with particularity, the provision(s) to which you object and 
the grounds for your objection. Within each numbered objection, you 
must specifically state whether you are requesting a hearing on the 
particular provision that you specify in that numbered objection. If 
you do not request a hearing for any particular objection, you waive 
the right to a hearing on that objection. If you request a hearing, 
your objection must include a detailed description and analysis of the 
specific factual information you intend to present in support of the 
objection in the event that a hearing is held. If you do not include 
such a description and analysis for any particular objection, you waive 
the right to a hearing on the objection.
    Any objections received in response to the regulation may be seen 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov. We will publish notice of the objections that we 
have received or lack thereof in the Federal Register.

IX. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the 
date this document publishes in the Federal Register, but Web sites are 
subject to change over time.

    1. Rice, P.A. ``C6-Perfluorinated Compounds: The New 
Greaseproofing Agents in Food Packaging,'' Current Environmental 
Health Reports, 2:1, pp. 33-40, 2015.
    2. International Agency for Research on Cancer, http://monographs.iarc.fr/ENG/Monographs/vol81/mono81-8.pdf.
    3. FDA Memorandum from P. Rice to P. Honigfort, September 30, 
2010.
    4. FDA Memorandum from P. Rice to P. Honigfort, July 27, 2015.
    5. FDA Memorandum from J. Cooper to P. Honigfort, July 23, 2015.

List of Subjects in 21 CFR Part 176

    Food additives, Food packaging.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and re-
delegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR part 176 is amended as follows:

PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS

0
1. The authority citation for 21 CFR part 176 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 346, 348, 379e.


Sec.  176.170  [Amended]

0
2. Amend Sec.  176.170 in the table in paragraph (a)(5) by removing the 
entries for ``Diethanolamine salts of mono- and bis,'' ``Pentanoic 
acid,'' and ``Perfluoroalkyl substituted phosphate ester acids.''

    Dated: December 29, 2015.
Susan Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for 
Food Safety and Applied Nutrition.
[FR Doc. 2015-33026 Filed 12-31-15; 8:45 am]
 BILLING CODE 4164-01-P