Food Additives; Threshold of Regulation for Substances Used in Food-Contact Articles

Forms and Documents

Document Name	Status
SS-0910-0298.doc Supporting Statement A	2010-06-28

IC Document Collections

IC ID	Document Title	Status
5864	Food Additives; Threshold of Regulation for Substances Used in Food-Contact Articles	Modified

ICR Details

OMB Control No: 0910-0298	ICR Reference No: 201006-0910-006
Status: Historical Active	Previous ICR Reference No: 200703-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Food Additives; Threshold of Regulation for Substances Used in Food-Contact Articles
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/11/2010
	Date Received in OIRA: 06/28/2010
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years. In its next request, FDA should provide an electronic option for submitting this information, provide a timeline for completing an electronic option for submission, or explain why an electronic option is not appropriate.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2013	36 Months From Approved	10/31/2010
Responses	7	0	15
Time Burden (Hours)	336	0	720
Cost Burden (Dollars)	0	0	0

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Abstract: 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 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 regulateddirect 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 21 CFR 170.39 ( c ) must be submitted to FDA.

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Authorizing Statute(s): US Code: 21 USC 348 Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 18209	04/09/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 36091	06/24/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Food Additives; Threshold of Regulation for Substances Used in Food-Contact Articles

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	7	15	0	0	-8	0
Annual Time Burden (Hours)	336	720	0	0	-384	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $16,426

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 06/28/2010

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