Document ID: FDA-2010-N-0181-0002
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: 2010-06-24T04:00Z

[Federal Register: June 24, 2010 (Volume 75, Number 121)]
[Notices]               
[Page 36091-36092]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jn10-47]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
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 July 
26, 2010.

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 e-mailed 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

[[Page 36092]]

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:  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--
(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), (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), 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 April 9, 2010 (75 FR 18209), 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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                       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 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.
    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: June 16, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-15302 Filed 6-23-10; 8:45 am]
BILLING CODE 4160-01-S