[Federal Register: September 16, 2003 (Volume 68, Number 179)]
[Page 54232-54233]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 54232]]



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.


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 

                                                     Table 1.--Estimated Annual Reporting Burden \1\
                                                     Annual Frequency per
       21 CFR Section          No. of Respondents          Response          Total Annual Responses        Hours per Response           Total Hours
170.39                                          6                      1                           6                          48                    288
\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]