Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have Been Revoked, Suspended, or Modified by the EPA

ICR 200805-0910-007

OMB: 0910-0562

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2008-05-13
ICR Details
0910-0562 200805-0910-007
Historical Active 200502-0910-002
HHS/FDA
Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have Been Revoked, Suspended, or Modified by the EPA
Extension without change of a currently approved collection   No
Regular
Approved without change 07/01/2008
Retrieve Notice of Action (NOA) 05/19/2008
  Inventory as of this Action Requested Previously Approved
07/31/2011 36 Months From Approved 06/30/2008
2 0 652
19 0 2,998
0 0 32,000

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guidance, "Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations," represents the agency's current thinking on its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and how that provision relates to FDA-regulated products with residues of pesticide chemicals for which tolerances have been revoked, suspended, or modified by EPA pursuant to dietary risk considerations.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 If FDA encounters food bearing a residue of a pesticide chemical for which the tolerance has been revoked, suspended, or modified, it intends to address the situation in accordance with provisions of the guidance.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to contain pesticide chemical residues (within the former tolerance) after the tolerance for the pesticide chemical has been revoked, suspended, or modified will be able to demonstrate that such food was handled, e.g., packed or processed, during the acceptable timeframes cited in the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.

US Code: 21 USC 346 Name of Law: FFDCA
  
None

Not associated with rulemaking

  73 FR 10033 02/25/2008
73 FR 28484 05/16/2008
No

  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
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Jonnalynn Capezzuto 3018274659

  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.
05/19/2008


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