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Comment: Assessment of Environmental Impact Has No Place in FDA's Food-Contact Clearance Process

By Keller and Heckman LLP’s Packaging Practice Group

Companies seeking clearance to bring new packaging materials to market have long been required to include an assessment of the likely impact upon the environment of their production, use, and disposal. That requirement existed under the U.S. Food and Drug Administration's food additive petition process, and continues today under the agency's food-contact notification regulatory scheme.1

The need to conduct an environmental assessment stems from the National Environmental Policy Act (NEPA). That legislation requires a federal agency to prepare an environmental impact statement (EIS) for any "major federal action significantly affecting the quality of the human environment." Where the environmental effects of a proposed action are uncertain, the agency must conduct or request from an applicant an environmental assessment, which provides evidence and analysis for determining whether the agency should prepare an EIS or issue a finding of no significant impact (FONSI). Accordingly, the agency will not accept a food-contact notification or food additive petition that is not accompanied by an environmental assessment, unless a categorical exclusion applies.2

But do environmental impact statements belong in the food-contact clearance process? A persuasive argument can be made that they do not.

Federal Action Marginal, Not Major

The Council on Environmental Quality, the entity with the task of implementing NEPA's requirements for federal agencies, defines a "major federal action" as an action "with effects that may be major and which are potentially subject to Federal control and responsibility."3

In Sierra Club v. Penfold,4 the U.S. Court of Appeals for the Ninth Circuit visited the issue of what constitutes a "major federal action," in the context of a regulatory scheme that is strikingly similar to the food-contact notification program.

At issue in Penfold was whether the systematic approval of five-acre "notice mine" operations was a major federal action that implicated NEPA. Notice mines are operations that cause five acres or less of surface disturbance per year. Prior approval of the Bureau of Land Management is not required before a miner can begin developing the mine, provided that the operator notifies BLM with certain information at least 15 days prior to commencing mining operations. After BLM has reviewed the notice, it sends the operator a letter either indicating that the information in the notice is complete or that the notice is incomplete and more information is required.

The Sierra Club contended that BLM's processing of notice mines constituted major federal action triggering NEPA. As indicia of major federal action, the Sierra Club pointed to BLM's extensive review of mine notices, the agency's policies and practices in implementing notice regulations, its compliance inspection, its approval conveyed through a letter to the mine operator, and NEPA's broad mandate obligating compliance to the fullest extent possible.

The Ninth Circuit held, however, that BLM's involvement in the notice mining process did not constitute major federal action. Specifically, the court found that "BLM's review of Notice mines is only a marginal federal action rather than a major action."

An important factor in the court's analysis was the absence of a requirement for affirmative BLM action to allow commencement of notice mining operations. The only requirements were the filing of a notice and the lack of a BLM request for additional information. This notice procedure was not converted from a "marginal" to a "major" federal action by BLM's authority to monitor compliance or to take enforcement action.

BLM's actions as part of the notice mine review process are remarkably similar to FDA's obligations under the food-contact notification program. Both agency schemes are based on notifications that must be submitted a specific number of days prior to the applicants' taking action on the notifications. Both agencies require, as part of the notifications, detailed descriptions of the projects. And neither type of applicant must await official agency approval prior to engaging in its activity.

To the extent there are differences between the roles of BLM and FDA, the differences militate against considering food-contact notification to be a major federal action. For instance, FDA has no continuing obligation to monitor the environmental impact of a food-contact notification applicant's operations. In Penfold, this monitoring obligation was advanced as a basis for finding BLM's role in notice mining to be a major federal action. Nevertheless, even this additional involvement was not enough for the court to subject the notice mining process to NEPA.

Unfortunately, FDA continues to require environmental assessments for food-contact clearances without taking account (at least publicly) of the Penfold precedent.

Impact on Environment Marginal as Well

A second requirement for NEPA to apply to food-contact notifications is that FDA's action must be one "significantly affecting the quality of the human environment."

NEPA's "opaque" and "woefully ambiguous" language was considered by the Second Circuit in Hanly v. Kleindienst5. There, the court pointed out that almost every major federal action, no matter how limited in scope, has some sort of adverse effect on the human environment. By adding the word "significantly," the court said, Congress "demonstrated that before the agency in charge triggered [the procedure prescribed by NEPA], it should conclude that a greater environmental impact would result than from 'any major federal action.'"

In the absence of a congressional or administrative interpretation of the term, the Hanly court said, an agency determining whether a NEPA analysis is necessary should consider the extent to which the action will cause adverse environmental effects in excess of those created by existing uses in the area affected by it, and the absolute quantitative adverse environmental effects of the action itself, including the cumulative harm that results from its contribution to existing adverse conditions or uses in the affected area. As an example, the court noted that an additional highway in an area covered with roads would have less of an adverse impact than if it were constructed through a roadless national park. In short, an agency should look to the incremental environmental impact of an activity as compared to existing environmental conditions and other factors that may affect these conditions to determine whether NEPA calls for an environmental assessment.

The introduction of a new food-contact material could arguably increase the level or change the character of emissions from its manufacture. However, environmental emissions from the manufacture of food-contact materials are already comprehensively regulated by state and federal environmental authorities. Thus, with respect to emissions at the manufacturing site, FDA clearance of a food-contact material cannot have a significant environmental impact when one takes into account the comprehensive environmental regulation of manufacturing emissions in the United States. In fact, FDA has recognized this fact by eliminating the requirement for manufacturing site information in environmental assessments of food-contact substances.

The same is true with regard to disposal. The EPA and its state counterparts regulate landfills and incinerators. In fact, in its 1997 final rule expanding the categorical exclusions from the environmental assessment requirements, the FDA acknowledged that EPA and state regulation of landfills makes it unnecessary for FDA to review the potential impact of food-contact materials on this type of disposal.6

With regard to incineration, the FDA indicated that some requested food-contact clearances could potentially cause incinerators to exceed their emissions limits. However, as with manufacturing sites and landfills, the environmental regulatory structure has provisions to ensure that emissions limits are met and to remedy situations in which the limits are exceeded. Moreover, it should be kept in mind that the FDA is asked to review only a portion of new food-contact materials and new uses for existing materials, and that food-contact materials constitute only a fraction of the total waste stream that is directed to incinerators.

The FDA's limited role, combined with the existing environmental regulatory structure governing incinerators and their emissions, leads to the conclusion that FDA clearance of food-contact materials cannot have more than an insignificant, incremental impact on incinerator emissions and an environmental assessment is not required to evaluate this issue.

On the other hand, recycling, unlike landfills and incinerators, is not subject to comprehensive federal or state regulation that would serve to control the impact of a new entrant into the market. Nevertheless, FDA can have only a marginal and insignificant impact on recycling and on the environment by clearing materials for food-contact applications. That conclusion is supported by a review of statistics concerning the overall municipal solid waste (MSW) stream and the amount of the waste stream that is recycled.

In 1998, the EPA released a report7 finding that all types of containers and packaging-including steel, aluminum, glass, paper, plastics, wood, and other materials-comprise only 33 percent of MSW. Further, FDA addresses only food containers and packaging, which represents only a portion of the total packaging stream described in the MSW report. Only food packaging made of aluminum, steel, glass and plastic is recycled to any significant extent. The total MSW in these categories is 24 million tons, compared to 209.7 million tons of overall MSW. Thus, aluminum, steel, glass, and plastic waste represents only about 11 percent of MSW (and that figure includes packaging for all types of products, not just packaging for food).

It may be useful to focus specifically on plastic containers, since FDA has been most concerned in recent cases about the potential impact of new plastic materials on existing plastics recycling. According to the MSW report, the total presence in MSW of the three categories of plastic containers that are being recycled is approximately 2.7 million tons, or approximately 1 percent of total MSW. It may be possible for FDA clearance of a new material for rigid plastic containers to have an impact on current recycling of plastics. Even if that impact were cataclysmic, however, the amount of waste that would be affected is not significant when compared to the overall waste stream.

In actuality, the effect of FDA's clearance of food packaging materials on recycling, if any, will be marginal. Moreover, FDA does not even have the opportunity to review all new types of rigid containers. Packaging technologies are frequently introduced that do not require FDA clearance for various reasons. The fact that FDA clearance is not required for all food-contact articles that may impact recycling further supports the conclusion that the agency's potential effect on recycling is insignificant.

Finally, it is important to note that industry itself pays significant attention to the recyclability of new packaging materials and structures. When bringing a product to market in a new packaging material, prominent consumer product companies generally want to ensure compatibility of the new material with recycling for various reasons, including public perceptions, relationships with the recycling industry, and their dependence on the recyclability of products that they already have on the market. Keeping a product competitive today often involves not being at an environmental perception disadvantage. No high-profile companywould want to be known as the one that disrupted the recycling stream. It has become commonplace for consumer product companies contemplating the introduction of a significant new package that has the potential to affect recycling of existing containers to require data demonstrating the compatibility of the new package with the recycling system. This practice of showing recyclability exists separately from FDA's regulatory process, and applies to containers that do not even need clearance from the agency.8

It is not my contention that the marketplace precludes the use of containers that affect the existing recycling system. Such containers do appear in the recycling stream, but, in most (if not all) cases, they are not the result of any FDA action because they are constructed from substances that already have FDA clearance or that do not need it. The presence of new containers that pose issues for recycling is actually further evidence that FDA's food-contact notification system cannot have a significant, incremental effect on recycling.

In sum, if FDA clears a packaging material that affects recycling adversely, only a limited, insignificant fraction of the overall solid waste stream might be affected. In addition, food-contact materials that are subject to FDA's premarket clearance authority as "food additives" represent only a fraction of the overall feedstream for recycling. Furthermore, industry on its own is actively engaged in assuring the compatibility of new containers with the recycling process. As with all the other areas of potential environmental impact, FDA can have only a marginal effect on recycling by providing clearance for a food-contact material, making NEPA review of the clearance unnecessary.


Because FDA's review of food-contact notifications constitutes neither a "major federal action" nor an action that will have a significant impact on the human environment, FDA should not be required to assess the environmental impact of its review of food-contact notifications.


1Under 21 C.F.R. ß 25.15 ("General Procedures"), all food-additive petitions requesting agency action require the submission of an environmental assessment or a claim of categorical exclusion. FDA's May 11, 2000, final rule extended this requirement to food- contact notifications.


2FDA's regulations categorically exempt from the environmental assessment requirements substances that constitute less than 5 percent of the food-contact article, provided that the substances are intended to remain with the finished packaging material through use by consumers, as well as components of coatings and substances that are used in articles intended for repeated use.


340 C.F.R. 1508.18 (1998).


4Sierra Club v. Penfold, 857 F.2d 1307 (9th Cir. 1988).


5Hanly v. Kleindienst, 471 F.2d 823 (2d Cir. 1972).


6See 62 Fed. Reg. 40,570 (July 29, 1997).


7Characterization of Municipal Solid Waste in the United States: 1997 Update (prepared for the U.S. Environmental Protection Agency, Municipal and Industrial Solid Waste Division, Office of Solid Waste, Report No. EPA530-R-98-007, by Franklin Associates, Ltd., May, 1998).


8To be more specific, the Association of Post-Consumer Plastics Recyclers (APR), the trade association of the plastics recycling industry, has published guidelines on designing plastic containers for recyclability. In addition, APR has instituted a program known as Champions for Change, in which companies interested in introducing new types of containers are given the opportunity to work with recycler members of APR to conduct testing to demonstrate that the containers will not have a detrimental impact on the plastics recycling system. As an industry initiative, this procedure obviously is voluntary, but to a significant and increasing degree, the generation of this type of data on recyclability is a requirement for qualifying to supply packaging to major consumer product companies. In addition, establishing compatibility with recycling is becoming imperative to avoid an adverse reaction to a new package from recyclers and from local authorities responsible for recycling.