[Federal Register Volume 65, Number 182 (Tuesday, September 19, 2000)]
[Notices]
[Pages 56585-56586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-23884]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1501]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Extension; Threshold of Regulation for Substances Used 
in Food-Contact Articles

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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.

DATES: Submit written or electronic comments on the collection of 
information by November 20, 2000.

ADDRESSES: Submit electronic comments on the collection of information 
via the Internet at: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/edockethome.cfm. Submit written comments on the collection of 
information to the Dockets Management Branch (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: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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

[[Page 56586]]

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

                                 Table 1.--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                         No. of       Annual  Frequency     Total Annual        Hours per
  21 CFR Section      Respondents       per  Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
      170.39               6                  1                  6                 48               288
----------------------------------------------------------------------------------------------------------------
\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: September 12, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-23884 Filed 9-18-00; 8:45 am]
BILLING CODE 4160-01-F