[Federal Register Volume 72, Number 55 (Thursday, March 22, 2007)]
[Notices]
[Pages 13499-13500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5196]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0527]


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 a 
proposed collection of information 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 April 
23, 2007.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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 January 8, 2007 (72 FR 792), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 13500]]



                                 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                                 15                   1                  15                48          720
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    In compiling these estimates, FDA consulted its records of the 
number of regulation exemption requests received in the past 3 years. 
The annual hours per response reporting estimate is based on 
information received from representatives of the food packaging and 
processing industries and agency records.
    FDA estimates that approximately 15 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 for food-contact substances 
established by section 409(h) of the act (OMB control number 0910-0495) 
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 Web site 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: March 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-5196 Filed 3-21-07; 8:45 am]
BILLING CODE 4160-01-S