
[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Notices]
[Pages 74453-74454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25793]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0730]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Threshold of 
Regulation for Substances Used in Food-Contact Articles

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
November 25, 2016.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs,

[[Page 74454]]

OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to 
oira_submission@omb.eop.gov. All comments should be identified with the 
OMB control number 0910-0298. Also include the FDA docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Threshold of Regulation for Substances Used in Food-Contact Articles--
21 CFR 170.39 (OMB Control Number 0910-0298)--Extension

    Under section 409(a) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 348(a)), the use of a food additive is deemed 
unsafe unless one of the following is applicable: (1) It conforms to an 
exemption for investigational use under section 409(j) of the FD&C Act; 
(2) it conforms to the terms of a regulation prescribing its use; or 
(3) in the case of a food additive which meets the definition of a 
food-contact substance in section 409(h)(6) of the FD&C Act, there is 
either a regulation authorizing its use in accordance with section 
409(a)(3)(A) or an effective notification in accordance with section 
409(a)(3)(B).
    The regulations in Sec.  170.39 (21 CFR 170.39) established a 
process that provides the manufacturer with an opportunity to 
demonstrate that the likelihood or extent of migration to food of a 
substance used in a food-contact article is so trivial that the use 
need not be the subject of a food additive listing regulation or an 
effective notification. The Agency has established two thresholds for 
the regulation of substances used in food-contact articles. The first 
exempts those substances used in food-contact articles where the 
resulting dietary concentration would be at or below 0.5 parts per 
billion. The second exempts regulated direct food additives for use in 
food-contact articles where the resulting dietary exposure is 1 percent 
or less of the acceptable daily intake for these substances.
    In order to determine whether the intended use of a substance in a 
food-contact article meets the threshold criteria, certain information 
specified in Sec.  170.39(c) must be submitted to FDA. This information 
includes the following components: (1) The chemical composition of the 
substance for which the request is made, (2) detailed information on 
the conditions of use of the substance, (3) a clear statement of the 
basis for the request for exemption from regulation as a food additive, 
(4) data that will enable FDA to estimate the daily dietary 
concentration resulting from the proposed use of the substance, (5) 
results of a literature search for toxicological data on the substance 
and its impurities, and (6) information on the environmental impact 
that would result from the proposed use.
    FDA uses this information to determine whether the food-contact 
article meets the threshold criteria. Respondents to this information 
collection are individual manufacturers and suppliers of substances 
used in food-contact articles (i.e., food packaging and food processing 
equipment) or of the articles themselves.
    In the Federal Register of May 11, 2016 (81 FR 29271), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                           21 CFR 170.39                                Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Threshold of regulation for substances used in food-contact                       7                1                7               48              336
 articles..........................................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In compiling these estimates, we consulted our records of the 
number of regulation exemption requests received in the past 3 years. 
The annual hours per response reporting estimate of 48 hours is based 
on information received from representatives of the food packaging and 
processing industries and Agency records.
    We estimate that approximately 7 requests per year will be 
submitted under the threshold of regulation exemption process of Sec.  
170.39, for a total of 336 hours. The threshold of regulation process 
offers one advantage over the premarket notification process for food-
contact substances established by section 409(h) of the FD&C Act (OMB 
control number 0910-0495) in that the use of a substance exempted by 
FDA is not limited to only the manufacturer or supplier who submitted 
the request for an exemption. Other manufacturers or suppliers may use 
exempted substances in food-contact articles as long as the conditions 
of use (e.g., use levels, temperature, type of food contacted, etc.) 
are those for which the exemption was issued. As a result, the overall 
burden on both Agency and the regulated industry would be significantly 
less in that other manufacturers and suppliers would not have to 
prepare, and we would not have to review, similar submissions for 
identical components of food-contact articles used under identical 
conditions. Manufacturers and other interested persons can easily 
access an up-to-date list of exempted substances which is on display at 
FDA's Division of Dockets Management and on the Internet at http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/ThresholdRegulationExemptions/ucm093685.htm. Having the list of 
exempted substances publicly available decreases the likelihood that a 
company would submit a food additive petition or a notification for the 
same type of food-contact application of a substance for which the 
Agency has previously granted an exemption from the food additive 
listing regulation requirement.

    Dated: October 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25793 Filed 10-25-16; 8:45 am]
BILLING CODE 4164-01-P


