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Recyclability of New or Improved Food Packaging Materials May Raise Issues for FDA

Dealing with recycling issues in an environmental assessment (EA) remains relevant under the U.S. Food and Drug Administration's (FDA) Food Contact Notification (FCN) program, implemented in January 2000.

The National Environmental Policy Act (NEPA) requires all federal agencies to assess the environmental impact of their major actions and to ensure that the interested and affected public is informed of environmental analyses. In its May 11, 2000, direct final rule (65 Fed. Reg. 30352), FDA states that a notification for a food-contact substance must contain either an EA or a claim of categorical exclusion; this is also the practice with food additive petitions. If the environmental component of a notification is missing or deficient, the agency will not accept the notification for review.

No significant impact

With respect to an FCN for a plastic product or additive that may enter the recycling stream, the EA must demonstrate that there will be no significant impact on recycling. FDA assumes that an adverse impact on recycling is a significant impact on the environment. As discussed further below, although there are no published FDA criteria or standards to demonstrate that there will be no significant impact on recycling, companies have developed testing approaches to satisfy this burden. The most important factor in this determination is demonstrating that the end markets for recycled plastics will not be affected adversely.

Under 21 C.F.R. § 25.15 ("General procedures"), all petitions requesting agency action require the submission of an EA or a claim of categorical exclusion. FDA's May 11, 2000, final rule extends this requirement to FCNs. The final rule also extends the existing categorical exclusions available for food additive petitions and threshold of regulation exemption requests to FCNs because the effects on the environment of allowing the marketing of the substances are comparable regardless of the authorization process. FDA currently expects that most FCNs will be subject to one of the categorical exclusions. As defined in 40 C.F.R. § 1508.4 ("Categorical exclusion"), a categorical exclusion is a category of actions that do not individually or cumulatively have a significant effect on the environment and for which neither an EA nor an Environmental Impact Statement (EIS) is required. However, as indicated in 21 C.F.R. § 25.21 ("Extraordinary circumstances"), FDA will require at least an EA for any specific action that ordinarily would be excluded if extraordinary circumstances indicate that the specific proposed action may significantly affect the quality of the human environment, such as the potential for serious harm to the environment at the expected level of exposure.

Actions listed in Section 25.32 ("Foods, food additives, and color additives") are categorically excluded and ordinarily do not require the preparation of an EA as noted in the following paragraphs of this section:

(i) When the substance is present in finished food-packaging material at not greater than 5 percent-by-weight and is expected to remain with finished food packaging material through use by consumers or when the substance is a component of a coating of a finished food packaging material.

(j) When the substance is to be used as a component of a food contact surface of permanent or semipermanent equipment or of another food contact article intended for repeated use.

(k) For substances added directly to food that are intended to remain in food through ingestion by consumers and that are not intended to replace macronutrients in food.

(q) A substance registered by the Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for the same use requested in the petition, request for exemption, or notification.

(r) A substance which occurs naturally in the environment, when the action does not alter significantly the concentration or distribution of the substance, its metabolites, or degradation products in the environment.

Establishing recyclability presents challenge

In practice, when a categorical exclusion is not available and an EA is required, some companies have found it difficult to establish recyclability of a product to FDA's satisfaction. A successful EA in an FCN must demonstrate why the new food contact substance will not reduce the existing recycling rates or otherwise affect recycling negatively. FDA, however, has provided no public guidance on how to prove that a certain material will be recycled adequately and will not have a significant adverse impact on existing recycling.

Recycling issues arise most often in the case of new polymers intended for use in making containers previously made of polyethylene terephthalate (PET), as well as substances proposed for making modified versions of PET. FDA is aware that PET is recycled to a significant extent, and is concerned that new polymers or PET variants used in the same or similar applications as traditional PET may disrupt the current PET recycling system. The perceived risk is that containers may appear to be composed of PET and enter the established recycling stream, but turn out not to recycle in the same way as PET.

There are two basic ways to address FDA's concerns about materials that may replace or modify PET. One is to establish that the new material will not enter the PET recycling stream. This approach was taken with polyethylene naphthalate (PEN) homopolymer. The FDA regulation clearing PEN (21 C.F.R. § 177.1637 - "Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins") requires containers made of the polymer to bear a distinguishing mark so that they can be separated from PET for recycling.

More often, separate recycling of a polymer similar to PET is not desirable or feasible. In those cases, FDA has required a significant amount of evidence to demonstrate that the presence of the substance will not disrupt PET recycling. Typically, this proof takes the form of studies showing that the new material can be recycled with PET to produce recycled resin suitable for its end uses. A complicating factor is that the testing must address the multiple applications for recycled PET: fiber (for carpet and textiles), new bottles and jars, sheet, and strapping. Each of these uses has different processing and performance requirements, which must be addressed with data to satisfy FDA.

An additional complication results from FDA's lack of established criteria for sufficient proof of recycling compatibility. Unlike the agency's basic function of assessing a packaging material's safety, the environmental review process does not have well-defined standards. Therefore, it has been difficult for both FDA and industry to determine when there is enough data on the recycling issue.

In addition to the questions raised by substances that may enter an existing recycling process, such as the modified versions of PET, recycling questions will be raised by FDA with respect to any new substance that may replace a currently recycled material, such as PET, high density polyethylene (HDPE), aluminum, or glass. These situations require assurance to FDA that the new material will be recycled or disposed of in another way that does not involve a significant environmental impact. Possible adverse effects include increases in the volume of waste sent to landfills or in emissions of concern from incinerators. Another potential issue is increased energy consumption to make new material and packaging if none is recycled.

Avoiding the process

The FDA environmental review process may be avoided if it can be established that a substance will not migrate at detectable levels or is generally recognized as safe (GRAS), so that it is not a food additive and does not require FDA clearance. Consumer product companies, however, often require similar proof of recyclability as part of qualifying a new material. Fortunately, the Association of Post Consumer Plastics Recyclers (APR, a Keller and Heckman client) has a useful program in this area, "Champions for Change." Under this program, APR puts developers of new plastic packaging materials in touch with plastics recyclers who are members of APR and who are willing to help determine the recyclability of the new material. Financial terms for such assistance must be negotiated, but this process is an effective way to generate data to satisfy both FDA and potential customers for the material.

In conclusion, companies with new or improved food packaging materials need to be aware that recyclability may be an issue for FDA and customers. The absence of established FDA criteria complicates the task of satisfying the agency, and is a reason for avoiding review by FDA, if possible. Customers, however, may require similar proof of recyclability, and Keller and Heckman has experience and contacts that can help develop and implement the appropriate testing.