[Federal Register: January 23, 2004 (Volume 69, Number 15)]
[Notices]
[Page 3372-3373]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23ja04-61]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0397]
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 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: Fax written comments on the collection of information by
February 23, 2004.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
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: 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) 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 (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 September 16, 2003 (68 FR 54232), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden for this collection of information as
follows:
[[Page 3373]]
Table 1. --Estimated Annual Reporting Burden\1\
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Annual
21 CFR Section No. of Frequencyper Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
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.
Under section 409(a) of the act, 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.
Dated: January 16, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-1472 Filed 1-22-04; 8:45 am]
BILLING CODE 4160-01-S