[Federal Register Volume 65, Number 248 (Tuesday, December 26, 2000)]
[Notices]
[Pages 81530-81531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32784]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1501]


Agency Information Collection Activities; Submission for OMB 
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 the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
January 25, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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 act) (21 U.S.C. 348(a)), the use of a food additive is deemed 
unsafe unless: (1) It conforms to an exemption for investigational use 
under 409(j); (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).
    In the Federal Register of July 17, 1995 (60 FR 36582), 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 parts 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.
    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: (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 September 19, 2000 (65 FR 56585), the 
agency requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 81531]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                             Annual Frequency     Total Annual
                21 CFR Section                      No. of Respondents         per Response         Responses      Hours per Response      Total Hours
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170.39                                                                  6                   1                 6                    48               288
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The above annual reporting estimate is based on information 
received from representatives of the food packaging and processing 
industries and on agency records. In the past, FDA has typically 
received 60 threshold of regulation exemption requests per year.
    However, it is estimated that up to 90 percent of the requests that 
would have previously been submitted under Sec. 170.39 will now be 
submitted under the premarket notification process for food-contact 
substances established by section 409(h) of the act.

    Dated: December 18, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-32784 Filed 12-22-00; 8:45 am]
BILLING CODE: 4160-01-S