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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec 562.700 Labeling of Food Bearing Residues of Pesticide Chemicals February 1989

Final
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition
Office of Regulatory Affairs

BACKGROUND:

*Pesticide residues resulting from preharvest application to raw agricultural commodities have never been considered ingredients subject to the label declaration required by section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act.

Public Law 86-537 amended the Act by adding section 403(l), as follows:

"(1) If it is a raw agricultural commodity which is the produce of the soil, bearing or containing a pesticide chemical applied after harvest, unless the shipping container of such commodity bears labeling which declares the presence of such chemical in or on such commodity and the common or usual name and the function of such chemical: Provided, however, that no such declaration shall be required while such commodity, having been removed from the shipping container, is being held or displayed for sale at retail out of such container in accordance with the custom of the trade."

This exemption, however, does not necessarily apply to pesticide chemicals added to articles such as fish or other seafoods which are not "produce of the soil."

When produce is packed into bags which are then packed and shipped in master cartons, each of which holds 2 or more bags, the master cartons are the "shipping containers" that should bear the information prescribed by section 403(l). On the other hand, when potatoes are shipped in bags not enclosed in master cartons or similar shipping containers, the bags themselves are "shipping containers," each of which should bear the required declarations.*

POLICY:

Residues of pesticide chemicals that are applied either pre-harvest or post-harvest to raw agriculture commodities which are the "produce of the soil" are exempt from the labeling requirements of sections 403(i)(2) and 403(k) of the Act. However, when such chemicals are applied post-harvest to such commodities, section 403(l) of the Act requires that the shipping containers of the commodities bear the common or usual name and function of the chemicals.

When individual bags, berry boxes, or similar containers of raw agricultural commodities which are produce of the soil are packed into master cartons for shipment, only the master cartons must bear the declaration required by section 403(l). If, on the other hand, the bags, boxes, or other packages are not packed into other containers, but are shipped individually, each individual bag or other container becomes a "shipping container" which must bear the required declaration.

*Material between asterisks is new or revised.*

Issued: 7/8/69
Revised: 11/19/79
Reissued: 10/1/80; 2/1/89


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

 
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