[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Pages 63217-63218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-24804]


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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 22, 2013.

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, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. 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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

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), 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 part per 
billion (ppb). 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 June 26, 2013 (78 FR 38349), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.

[[Page 63218]]

    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                           No. of
                           21 CFR 170.39                                  No. 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, FDA consulted its records of the 
number of regulation exemption requests received in the past three 
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.
    FDA estimates 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) (OMB control number 
0910-0495) in that the use of a substance exempted by the Agency 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 the Agency and the regulated industry would be significantly less 
in that other manufacturers and suppliers would not have to prepare, 
and FDA 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/default.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 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-24804 Filed 10-22-13; 8:45 am]
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