FDA proposes to reduce environmental filing burdens.

Converters, suppliers, and food companies commonly seek "clearances" from the Food and Drug Administration (FDA) by filing food additive petitions, "generally recognized as safe" (GRAS) affirmation petitions, and "threshold of regulation" requests. The problem is that firms seeking such clearances must also provide a detailed environmental assessment (EA) of the impact of their request. This can be an extremely difficult burden, because EAs are often expensive and time-consuming to prepare.

It was welcome news, therefore, when the FDA recently announced a proposed rule that would decrease the regulatory burden on industry with regard to filing EAs. Unfortunately, the FDA proposal does not go far enough. It would still require EAs be submitted as part of certain petitions and even some threshold of regulation requests, despite the fact that, in the 21 years since the filing of EAs became required, in only two cases has FDA required the preparation of an environmental impact statement. The reason is that all other indirect food additive petitions have resulted in a "finding of no significant impact" on the environment, eliminating the need for the environmental impact statement.

The preparation of an EA is required, subject to certain exceptions, pursuant to FDA regulations implementing the National Environmental Policy Act. NEPA requires an environmental impact statement for actions that significantly affect the quality of the human environment.

EAs contain environmental information on a proposed action and form the basis for FDA to determine whether an environmental impact statement or a "finding of no significant impact" should be prepared. Based on the agency's experience, certain types of substances generally do not raise significant environmental concerns.

FDA now proposes two things. The first is to increase the number of submissions to FDA that would be categorically excluded from the need to prepare an EA. The second is that submissions still requiring preparation of an EA would no longer require information on manufacturing sites or certification of compliance with federal, state, and local emissions requirements.

Under the rule FDA would not require petitioners to submit EAs as part of food additive petitions or threshold of regulation requests where the "additive" is a "functional component of finished food packaging materials present at not greater than 5%-by-weight." Such submissions now must include an abbreviated EA.

In the case of "nonfunctional" additives, e.g., catalysts and emulsifiers, present at less than 5% by weight of the finished food packaging material, an abbreviated EA will still be necessary. FDA makes a distinction between functional and nonfunctional components in this instance, because non functional components may create a potential for exposure at the site of use.

The rule also provides categorical exclusion from the need for an EA for food additive petitions and threshold of regulation requests for food contact articles intended for repeated use. FDA found that the use of such articles, with their limited market and extended life spans, does not significantly affect the environment.

The proposed categorical exclusion also applies to petitions to establish or amend regulations for prior sanctioned food ingredients and to GRAS affirmation petitions (including components of food packaging) if the substance is already marketed in the US for the use.

Also, actions to prohibit or otherwise restrict or reduce the use of a substance in food, food packaging, or cosmetics (e.g., the withdrawal of approval of the use of a food or color additive) are excluded from the current EA requirements.

These exclusions would be very useful; however, the proposal could be expanded to remove FDA from the environmental assessment business entirely. Other federal and state authorities pervasively regulate the environmental effects of the manufacture, use, and disposal of the products subject to FDA's jurisdiction. FDA rulings on the regulatory status of products have, at most, indirect effects on the environment. Such effects are then subject to the control of laws, regulations, and authorities directly concerned with the environment. FDA's oversight is not needed to assure that its activities do not have a significant adverse effect on the environment since environmental impact is not the principal focus of FDA's regulatory activity and expertise.

Malcolm D. MacArthur is legal counsel to the Flexible Packaging Association, other trade groups, and corporations.


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