[Federal Register Volume 69, Number 15 (Friday, January 23, 2004)]
[Notices]
[Pages 3372-3373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-1472]


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

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.

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

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\
----------------------------------------------------------------------------------------------------------------
                                                 Annual
    21 CFR Section           No. of           Frequencyper        Total Annual         Hours per     Total Hours
                           Respondents          Response            Responses          Response
----------------------------------------------------------------------------------------------------------------
170.39                                  6                   1                   6                48          288
----------------------------------------------------------------------------------------------------------------
\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