[Federal Register: January 8, 2007 (Volume 72, Number 4)]
[Page 792-793]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2006N-0527]

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.


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 March 9, 2007.

ADDRESSES:  Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: 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: 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 (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

[[Page 793]]

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 
    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 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                                     Annual Frequency per      Total Annual
                21 CFR Section                  No. of Respondents         Response              Responses        Hours per 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 Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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: December 29, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-6 Filed 1-5-07; 8:45 am]