FDA VS. EPA: WHICH COMPLIANCE DO YOU REALLY NEED?

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FDA VS. EPA: WHICH COMPLIANCE DO YOU REALLY NEED?
16 April 2007 - Dow Corning - EEI

In 1996, Congress passed the Food Quality Protection Act. The FQPA amended the Federal Food, Drug, and Cosmetic Act, section 408, to eliminate the overlapping authority regarding pesticides in food that existed between the FDA and EPA. This gave regulatory authority for pesticides applied to raw agricultural commodities solely to the EPA. The FDA regulatory authority now starts where the EPA leaves off, with the processing of these same commodities. In summary:

The United States Food and Drug Administration regulates defoaming agents...

Used as Secondary Direct Food Additives (21 CFR 173.340). This regulation covers defoamers that may be safely used in processing foods when used in accordance with this regulation. In these applications, the antifoam becomes an inseparable part of a food that will be consumed. Example: An antifoam used in a powdered drink mix to prevent foaming upon end use.

That will have Indirect Food Contact (21 CFR Parts 174 through 178). These regulations apply primarily to foam control agents used in the production of food packaging. The antifoam is used in a process that is one step removed from the food itself.

The United States Environmental Protection Agency regulates chemicals, including pesticides (herbicides, fungicides and insecticides), that will be used on growing crops or post-harvest agricultural commodities. Examples: growing corn plants and the harvested corn before it is processed.

Antifoam used in the production of a pesticide may be exempt from the requirement of a tolerance when used in accordance with the following subsections of the EPA regulation 40 CFR 180.1001:

(c) Residues are exempt from regulation when applied to either growing crops or raw commodities after harvest. (New 40 CFR designation 180.910)

(d) Residues are exempt when applied to growing crops only. (New 40 CFR designation 180.920)

(e) Residues are exempt when applied to food animals. (New 40 CFR designation 180.930)

For assistance in determining whether the regulatory status of a Dow Corning brand antifoam is appropriate for your application, contact your Dow Corning technical representative or e-mail Dow Corning at antifoams@dowcorning.com

http://www.dowcorning.com

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