Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have Been Revoked, Suspended, or Modified by the EPA

Forms and Documents

Document Name	Status
0562 ss 5-13-08.doc Supporting Statement A	2008-05-13

IC Document Collections

IC ID	Document Title	Status
6284	Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have Been Rovoked, Suspended, or Modified by the EPA Other-Guidance Document	Modified
184964	Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have Been Rovoked, Suspended, or Modified by the EPA Other-Guidance Document	New

ICR Details

OMB Control No: 0910-0562	ICR Reference No: 200805-0910-007
Status: Historical Active	Previous ICR Reference No: 200502-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have Been Revoked, Suspended, or Modified by the EPA
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: 07/01/2008
	Date Received in OIRA: 05/19/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2011	36 Months From Approved	06/30/2008
Responses	2	0	652
Time Burden (Hours)	19	0	2,998
Cost Burden (Dollars)	0	0	32,000

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Abstract: FDA's guidance, "Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations," represents the agency's current thinking on its planned enforcement approach to the channels of trade provision of the Federal Food, Drug, and Cosmetic Act and how that provision relates to FDA-regulated products with residues of pesticide chemicals for which tolerances have been revoked, suspended, or modified by EPA pursuant to dietary risk considerations. FDA anticipates that food bearing lawfully applied residues of pesticide chemicals that are the subject of future EPA action to revoke, suspend, or modify their tolerances, will remain in the channels of trade after the applicable tolerance is revoked, suspended, or modified. If FDA encounters food bearing a residue of a pesticide chemical for which the tolerance has been revoked, suspended, or modified, it intends to address the situation in accordance with provisions of the guidance. In general, FDA anticipates that the party responsible for food found to contain pesticide chemical residues (within the former tolerance) after the tolerance for the pesticide chemical has been revoked, suspended, or modified will be able to demonstrate that such food was handled, e.g., packed or processed, during the acceptable timeframes cited in the guidance by providing appropriate documentation to the agency as discussed in the guidance document. Examples of documentation which FDA anticipates will serve this purpose consist of documentation associated with packing codes, batch records, and inventory records. These are types of documents that many food processors routinely generate as part of their basic food-production operations.

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Authorizing Statute(s): US Code: 21 USC 346 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:
	73 FR 10033	02/25/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 28484	05/16/2008
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have Been Rovoked, Suspended, or Modified by the EPA
Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have Been Rovoked, Suspended, or Modified by the EPA

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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	2	652	0	0	-650	0
Annual Time Burden (Hours)	19	2,998	0	0	-2,979	0
Annual Cost Burden (Dollars)	0	32,000	0	0	-32,000	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: $0

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]? Uncollected

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)? Uncollected

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: 05/19/2008

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