[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Notices]
[Pages 29209-29211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13117]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on requests for data needed to evaluate 
requests for threshold of regulation exemptions for substances used in 
food-contact articles.

DATES: Submit either electronic or written comments on the collection 
of information by August 20, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before August 20, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 20, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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

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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 comments, that information will be 
posted on https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2019-N-2778 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Threshold of Regulation for 
Substances Used in Food-Contact Articles.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 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 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. 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;

[[Page 29211]]

(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.
    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                       4                1                4               48              192
 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 adjustments to decrease our 
burden estimate due to the decrease in the number of respondents. The 
adjustment resulted in decreases of 3 responses and 144 total burden 
hours.
    We estimate that approximately 4 requests per year will be 
submitted under the threshold of regulation exemption process of Sec.  
170.39, for a total of 192 hours. The threshold of regulation process 
offers an 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: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13117 Filed 6-20-19; 8:45 am]
BILLING CODE 4164-01-P