[Federal Register: September 16, 2003 (Volume 68, Number 179)]
[Notices]
[Page 54232-54233]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16se03-59]
[[Page 54232]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0397]
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 November 17, 2003.
ADDRESSES: Submit electronic comments on the collection of information
to: http://www.fda.gov/dockets/ecomments. 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: Peggy Robbins, Office of Management
Programs (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 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 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 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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Annual Frequency per
21 CFR Section No. of Respondents Response Total Annual 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.
[[Page 54233]]
The annual reporting estimate is based on information received from
representatives of the food packaging and processing industries and
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 been previously
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 (OMB control number 0910-0495). The main advantages
of the premarket notification process is that notifiers are guaranteed
a decision by FDA within 120 days of receipt of an acceptable
notification and, once approved, an effective notification is exclusive
to the manufacturer or supplier who submitted the request. Because the
types of information needed for approval under the premarket
notification process for those uses of food-contact articles involving
dietary concentrations of 0.5 ppb or less is identical to that required
under Sec. 170.39, the burden on industry for premarket notifications
will be similar to the burden for requests submitted under the existing
threshold of regulation process.
As indicated previously in this document, it is estimated that
approximately six requests per year will be submitted under the
threshold of regulation exemption process of Sec. 170.39. The
threshold of regulation process offers one advantage over the premarket
notification process 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: September 9, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-23561 Filed 9-15-03; 8:45 am]
BILLING CODE 4160-01-S