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