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

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: September 19, 2000 (Volume 65, Number 182)]
[Notices]
[Page 56585-56586]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se00-72]

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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.

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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.

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\
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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               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: 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

 
 

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