Document ID: FDA-2010-N-0181-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Threshold of Regulation for Substances Used in Food-Contact Articles
Posted Date: 2010-04-09T04:00Z

[Federal Register: April 9, 2010 (Volume 75, Number 68)]
[Notices]               
[Page 18209-18210]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ap10-90]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0181]

 
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) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the 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 exemption from 
the food additive listing regulation requirements that are submitted 
under part 170 (21 CFR part 170).

DATES: Submit written or electronic comments on the collection of 
information by June 8, 2010.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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.

[[Page 18210]]

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

                                 Table 1.--Estimated Annual Reporting Burden \1\
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                         No. of        Annual Frequency     Total Annual        Hours Per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
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170.39                             7                  1                  7                 48                336
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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) of the act (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.cfsan.fda.gov. 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: April 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8050 Filed 4-8-10; 8:45 am]
BILLING CODE 4160-01-S