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).
FDA's regulations in 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. Section 170.39(c) specifies criteria that must be met
to obtain an exemption from the food additive petition process for
food-contact articles. 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. Requests for exemptions from
the food additive listing regulation requirement under 21 CFR
170.39 are letter-type submissions from manufacturers of food
packaging and food processing equipment. These submissions are
reviewed by FDA personnel to ascertain if the substance(s) is
adequately identified and if the proposed use meets the criteria
specified in 21 CFR 170.39 for an exemption. If the data are
sufficient to support an exemption under 21 CFR 170.39, the agency
informs the requestor by letter that the intended use of the
substance in a food-contact article is not required to be the
subject of a food additive listing regulation or a food contact
notification. A critical element in FDA's Threshold of Regulation
Policy is that the use of a substance exempted by the agency is not
limited to only the manufacturer who submitted the request for an
exemption. Other manufacturers 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. 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 is
also available on the internet at
http://www.cfsan.fda.gov.
The increase in burden is due
to the increase in the estimated number of respondents.
$33,750
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman
No
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
0298 cover memo to OMB 3-13-2007.doc
0298 21cfr170.39.pdf
Food Additives; Threshold of Regulation for Substances Used in Food-Contact Articles