Committee to Advise on Reassessment and Transition - Paper #6
FDA Channels of Trade Guidance for Methyl Parathion
- "Guidance for Industry - Channels of Trade Policy for Commodities with Methyl Parathion Residues."
- Issued as "draft" by FDA with FR Notice of Availability on June 2, 2000 (65 FR 35376-35379)
- 60 day comment period till 8/1/00
- Available at www.cfsan.fda.gov under "What's New"
- Purpose-presents FDA's policy on its planned enforcement approach for foods containing methyl parathion residues in accordance with the "channels of trade" provision of the FQPA.
- Under Channels of Trade (COT) provision: If use of pesticide under FIFRA has been canceled, and the tolerance under FFDCA has been revoked, and FDA finds a residue in a food.
- The food is not "adulterated" because of the residue if the residue complies with former tolerance, and.
- The responsible party can demonstrate to FDA that application was made at a time/manner that was legal under FIFRA.
- Food that meets these two tests will not be subject to regulatory action because of the MP residue, and may remain in the channels of trade and be sold in the normal fashion.
- Some frozen foods may not be sold to consumers for up to 4 years after harvest of the crop, thus "channels of trade" status for a given pesticide/crop could extend to 4 years post harvest.
- Residues of MP on foods from 1999 crop:
- Last permitted date of application, 12/31/99.
- MP dissipated from ambient and refrigerated stored foods by 9/00 and 12/00, based upon EPA estimates.
- MP residue remains in frozen food indefinitely; food may be in COT 4 years post harvest.
- FDA's planned enforcement approach for 2000:
- Tolerance revocation finalized, ??/00.
- Till end of 2000, only foods necessarily from 2000 crop with MP residues subject to enforcement action, e.g. fresh lettuce
- For foods not necessarily from 2000 crop, e.g. apples, if MP residue is found (within former tolerance) FDA will not require a showing by responsible party, but will take enforcement action if it has information that MP was applied to crop in 2000.
- FDA's planned enforcement approach for beyond 2000:
- MP residues only expected to be present in frozen foods.
- If MP residues are found (within former tolerance) responsible party will have to show compliance with COT requirements to avoid enforcement action.
- Examples of types of documentation for showing:
- Packing codes, batch records, inventory records showing that.
- The frozen product was packed, formulated, or processed in 2000, or ingredients were purchased in 2000.
- Frozen carrots, packing code indicates packed in 6/00; OK
- Types of documentation for showing:
- Blended juices with MP residue; if tolerance remains for one commodity (cranberries) but is revoked for other (apples) processor will have to document that it took steps, e.g. testing, to ensure that incoming apples or apple concentrate, were MP free.
- Imported foods to be handled essentially the same as domestic.
- After tolerance revocation, imported items from 2000 crop year, e.g. lettuce, with MP residue would not be allowed to enter U.S.
- Starting in 2001, for frozen foods with an MP residue, entry will be detained pending showing of COT compliance.
- Attempt to minimize burden:
- Where parties will need to make a showing, to minimize burden, we cited examples of documentation that we believe most processors already maintain, e.g. packing code records, batch records, inventory records.
- Future FQPA revocations:
- FDA will consider issuing a generic guidance document incorporating the principles in the MP guidance if it believes that these principles can be applied in a broad manner for other pesticides.