[Federal Register Volume 84, Number 215 (Wednesday, November 6, 2019)]
[Notices]
[Pages 59831-59832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24230]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2778]


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 or we) 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 
December 6, 2019.

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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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 
(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 that 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 part 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.
    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. We use this information to 
determine whether the food-contact substance meets the threshold 
criteria.
    Description of Respondents: 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 21, 2019 (84 FR 29209), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate 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.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments. We estimate that 
approximately seven requests per year will be submitted under the 
threshold of regulation exemption process of Sec.  170.39, for a total 
of 336 hours. In the Federal Register of June 21, 2019, we estimated 
four requests per year. In reconsideration of the two to three requests 
that were received but did not become effective, we retain our previous 
estimate of seven requests per year, with

[[Page 59832]]

four of those requests becoming effective.
    The threshold of regulation process offers one advantage over the 
premarket notification process for food-contact substances established 
by section 409(h) of 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 Dockets Management 
Staff and on the internet at https://www.fda.gov/food/packaging-food-contact-substances-fcs/threshold-regulation-exemptions-substances-used-food-contact-articles. 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 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24230 Filed 11-5-19; 8:45 am]
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