In a previous Regulatory Report column, the U.S. Food and Drug Administration’s food contact substance notification program was discussed in general with reference to the regulatory and review process.[1] Any food contact notification (FCN) must have adequate chemistry, toxicology, and environmental information for complete evaluation of the proposed use with regard to human safety and environmental impact.

In this issue, we discuss the statutes and regulations that govern FDA’s environmental responsibilities in general, with specific reference to the Center for Food Safety and Applied Nutrition’s (CFSAN) actions, including food-contact notifications, food and color additive petitions, and requests for exemption from regulation as a food additive. The general environmental requirements are the same, regardless of the FDA center taking the action. However, each center has its own classes of categorical exclusions from the requirement to prepare an environmental assessment. The general environmental requirements for all agency actions are applicable to food contact notifications, which are used as an example in this article.

The National Environmental Policy Act
The U.S. has environmental responsibilities under the National Environmental Policy Act (NEPA) of 1969. NEPA requires federal agencies to take environmental considerations into account for all major and final agency actions. NEPA is divided into two sections: Title I contains the broad statement of national environmental policy and the “action-forcing” components of the statute; while Title II establishes the Council on Environmental Quality (CEQ), the regulatory body charged with overseeing NEPA implementation. In accordance with Title II, the regulations issued by CEQ require federal agencies to develop their own regulations to comply with the procedures and achieve the goals of NEPA.[2] FDA’s NEPA-implementing procedures to supplement the CEQ regulations are set forth in Title 21 of the Code of Federal Regulations Part 25.

NEPA is a declaration of the nation’s environmental policy and goals. It supplements FDA’s authority under the Federal Food, Drug, and Cosmetic Act (FFDCA) and other public health statutes but it does not supersede these statutes. It does not require substantive FDA decisions to favor environmental protection over other considerations mandated by other statutes the FDA administers, such as human health. NEPA is a full disclosure statute that requires public involvement. NEPA is also a broad statute that considers all aspects of the human environment. In addition, NEPA applies abroad and requires federal agencies to identify those actions that may have transboundary environmental effects; i.e., those potentially significant adverse environmental impact effects that are likely to result from actions taken across national borders.

FDA’s major and final actions that are subject to NEPA consideration are listed under 21 CFR 25. Examples pertaining to CFSAN’s actions include allowing a food contact substance notification to become effective, approval of food and color additive petitions and threshold of regulation submissions, regulations establishing labeling requirements, and regulations issued on the agency’s initiative. This article focuses on NEPA considerations for CFSAN actions.

Environmental Information
NEPA is a full disclosure statute and Sec. 1506.6(a) (Public Involvement) of the Council on Environmental Quality regulations implementing NEPA states that federal agencies must make diligent efforts to involve the public in preparing and implementing their NEPA procedures. As a result, the environmental record must be made publicly available at FDA’s Dockets at the time the action is taken, except where not allowed by statutes such as for a food contact notification before it becomes effective.[3]

FDA will not accept industry-initiated actions such as an FCN, a threshold of regulation (TOR) exemption request, or a petition for review if the environmental component is missing or deficient (21 CFR 25.15). Also, all CFSAN-initiated actions, such as issuance of a regulation, must contain an environmental component; specifically, either an environmental assessment (EA) or a claim of categorical exclusion from the need to prepare an environmental assessment.

Claim of categorical exclusion. A claim of categorical exclusion applies to FDA actions that do not individually or cumulatively affect the quality of the human environment and, therefore, do not require the preparation of either an EA or an environmental impact statement (EIS). An adequate claim of categorical exclusion must include a citation of the 21 CFR 25.32 subsection under which the exclusion is warranted, a statement of compliance with the categorical exclusion criteria, and a statement that there are no extraordinary circumstances that will require the submission of an EA (21 CFR 25.15).[4]

Extraordinary circumstances. In accordance with 40 CFR 1508.4 and 21 CFR 25.21, FDA will require at least an EA for any normally excluded action if extraordinary circumstances indicate that the proposed action may have a significant environmental effect. An extraordinary circumstance may be shown by data available to either the agency or industry sponsor. Data available to the agency include public information, information in the submission, and information the agency has received in other submissions. Examples of extraordinary circumstances that may apply to CFSAN actions are listed at the FDA’s web site.[5] The CEQ regulations have defined “significantly” to aid in determining the degree to which an action may affect the quality of the human environment. This definition should be considered when evaluating whether extraordinary circumstances exist that may warrant the submission of at least an EA.

Significance. Section 1508.27 of CEQ regulations states that the term “significantly,” as used in NEPA, requires considerations of both context and intensity. Context means that the significance of an action must be analyzed in several contexts, such as society as a whole (human, national), the affected region, the affected interests, and the locality. Significance varies with the setting of the proposed action. Both short- and long-term effects are relevant. Intensity refers to the severity of impact. Responsible officials must bear in mind that more than one agency may make decisions about partial aspects of a major action. Things to consider when assessing intensity are listed under Section 1508.27(b) of the CEQ regulations.

The Council on Environmental Quality’s view is that the information submitted in a request for categorical exclusion is usually sufficient to determine that the exclusion is applicable to the requested action. Therefore, FDA has formulated its categorical exclusions to include specific criteria so that, in most instances, a categorical exclusion can be determined simply by citing the exclusion listed in 21 CFR 25. Often, exclusions can be confirmed by review of other information available to the agency, either in industry submissions or in its own files, or published in the open literature. However, in limited instances, it may be necessary to submit additional information to the agency for industry-initiated actions, to establish that the criteria for a categorical exclusion have been met.

Inadequacies in a claim of categorical exclusion. A careful evaluation of the general environmental guidance available at FDA’s web site will aid submitters in preparing an adequate claim of categorical exclusion.[5] An inadequate claim may delay the review process of a submission. Examples of inadequacies in a claim of categorical exclusion are: 1) citation of the wrong exclusion; 2) claim lacks explicit statement that the exclusion complies with the applicable criteria and that there are no extraordinary circumstances that would require preparation of an EA; 3) exclusion applicable to only some, not all, of the uses requested in the submission; 4) the use requested in the claim is different from the use requested in other sections of the submission; and 5) there is insufficient evidence in the notification for the agency to determine if the exclusion criteria are met.

Environmental Assessment
Any industry-initiated action that is subject to NEPA must contain an adequate environmental assessment, as defined under 21 CFR 25.40, if it does not qualify for a claim of categorical exclusion or when extraordinary circumstances exist that would make an exclusion unwarranted, as determined by the submitter or by the agency. For example, the majority of proposed uses of Food Contact Substances (FCSs) qualify for categorical exclusion under 21 CFR 25.32 (i), (j), (q), or (r); those that do not qualify for categorical exclusion require at least an EA. If the information available to the agency is not sufficient to support a Finding of No Significant Impact (FONSI), then the agency must prepare an environmental impact statement (EIS) in accordance with 40 CFR 1500-1508.

There are four CFSAN-regulated uses of substances requiring at least an EA: 1) substances added directly to food and are intended to be macronutrient replacements; 2) substances used in the production and processing of food and are not intended to remain with food; 3) processing aids used in the production of food-packaging material and are not intended to remain as components of finished packaging; and, 4) components of food-packaging material present at greater than 5-percent-by-weight (wt.-%) of the finished packaging.

An adequate environmental assessment is one that addresses the relevant environmental issues and contains sufficient information to enable the agency to determine whether the proposed action may significantly affect the quality of the human environment. It must contain a brief discussion of 1) the need for the proposed action; 2) introductions, fate, and effects of the substances in the environment; 3) alternatives to the proposed action; and 4) the environmental impact of the proposed use as a result of use and disposal of the substance. Except for these four requirements, the agency’s NEPA-implementing regulations do not specify what data the EA must include to demonstrate that the proposed use is not expected to cause a significant impact on the environment. However, the agency is often unable to determine what impact the proposed use may have on the environment without additional information about the amounts of substances introduced into the environment, the fate of these substances in the environment, and the effects of such amounts on organisms in the environment. It is the submitter’s responsibility to demonstrate no significant impact on the environment as a result of the proposed use of the subject substance.

The agency has published guidance documents on its website to provide submitters with additional recommendations for information to be included in an EA to help the agency determine the potential of the proposed use to lead to significant environmental impacts as a result of use and disposal of the FDA-regulated article.[6] FDA also posts on its website the environmental records for effective food contact substance notifications, including environmental assessments, findings of no significant impacts, and supplements to the EAs.[7] Environmental assessments and FONSIs for other actions are placed at the dockets.

The environmental fate and effects data included in an EA could be either actual data or obtained by using prediction models such as the U.S. Environmental Protection Agency’s (EPA) ECOSAR and EPIWIN. CFSAN will accept data obtained from testing either under its own testing methods or those of any other entity such as the EPA, the Organization for Economic Co-operation and Development, or other international regulatory bodies. Regardless of the method used to determine no significant impact on the environment, the submitter should consider the physical/chemical properties of the subject substance (water solubility, dissociation constants in water, n-octanol/water partition coefficient (Kow), and vapor pressure or Henry’s Law constant), environmental depletion mechanisms (adsorption coefficient (Koc), aerobic and anaerobic biodegradation, hydrolysis, and photolysis), and effects data (aquatic toxicity mostly).

The agency has the responsibility to consider the impact of its actions on the use of natural resources and energy as required under NEPA, Section 102 (b)(6), which states that one goal of NEPA is to “enhance the quality of renewable resources and approach the maximum attainable recycling of depletable resources.” As a result, the EA for a new polymeric food additive (if it makes greater than 5% wt-% of the finished food packaging) or a new use of a polymeric material should focus on the identity of the polymer and on how it may impact the environment as a result of disposal by affecting solid waste management practices, such as recycling (resources and energy use), landfilling (groundwater contamination), and incineration (acid gas emissions). Specifically, an EA should discuss the environmental impacts of the proposed use as a result of the disposal of the polymeric packaging.

The EA should identify fully the new polymeric material and provide relevant physical, thermal, and mechanical properties such as melting point, glass transition point, intrinsic viscosity, melt flow, and crystallinity. This information is especially important to assess how the new polymer will affect use of energy and resources if it will replace recycled material and it is not, itself, recycled or is recycled at a different rate. Additional information needed to assess such impact is: 1) technical effect of the proposed substance; 2) estimated yearly market volume (confidential); 3) types of packaging, e.g., films, multi-component containers, bottles or other rigid containers; 4) size of containers (mass and volume); 5) intended food applications (specific food and beverage products); 6) method of disposal of the proposed packaging; and 7) currently used packaging materials that the proposed additive may compete with and replace.

When assessing the environmental impact of a new polymeric substances or a new use of a polymeric substance, the following specific questions should be considered:

1. Is the polymer intended to replace a similar substance already in use? Will it not change the potential uses or disposal pattern of the replaced packaging?

2. Will the polymer replace packaging that is recycled but it will not be recycled itself? If so, to what extent will it reduce the quantity of an existing material that is recycled, and how will it be distinguished from other recyclable packaging?

3. Will the polymer replace packaging that is recycled and will it be recycled itself? If so, then will it fit into established source separation, collection, reprocessing systems or will new systems have to be developed? Will the material be processed separately, or only with commingled materials? Also, will the package be distinctly marked to encourage recycling and minimize contamination of existing recycling systems? And finally, what markets exist for the recycled material, and does the FCS, if it is a modifier to the base polymer, open new markets for the modified polymer?

A careful evaluation of the general environmental guidance available at the Agency’s website will aid submitters in preparing an adequate EA.5 An inadequate EA may delay the review process of a submission. Examples of inadequacies in an EA are:

1. The use requested in the EA is different than the use requested in other sections of the industry submission.

2. Lacks an explicit statement that there are no extraordinary circumstances that apply to the site of production of the substance.

3. Not independent of the rest of the submission.

4. Does not include estimates of environmental introduction concentrations.

5. Does not include physical, thermal, and mechanical properties for polymeric substance.

6. Lacks a discussion of potential impact on solid waste management strategies.

7. Contains confidential information.

An EA may incorporate material by reference when the effect will be to cut down on bulk without impeding agency and public review of the action. The incorporated material shall be cited in the EA and its content summarized in the EA to the extent possible. No material may be incorporated by reference unless it is reasonably available for inspection by potentially interested persons. Material based on proprietary data which is itself not available for review and comment must not be incorporated by reference.

The agency has the obligation to consider the cumulative impact of its actions. Section 1508.7 of the CEQ regulations defines cumulative impact as “the impact on the environment which results from the incremental impact of the action when added to other past, present, and reasonably foreseeable future actions regardless of what agency (federal or non-federal) or person undertakes such other actions. Cumulative impacts can result from individually minor but collectively significant actions taking place over a period of time.”

Conclusion
As discussed, FDA must meet its environmental responsibilities under NEPA for all major and final agency actions. For CFSAN, such responsibilities are related to agency-initiated actions or industry-initiated actions. To satisfy the environmental requirement, any action must include either a claim of categorical exclusion or an environmental assessment. The classes of actions that are categorically excluded for FDA-regulated articles are set forth in 21 CFR 25.

Layla I. Batarseh, Ph.D., supervises the Environmental Review Team (ERT) in the Office of Food Additive Safety at FDA’s Center for Food Safety and Applied Nutrition (CFSAN). She is responsible for assuring that CFSAN actions meet the requirements of the National Environmental Policy Act (NEPA) and comply with the regulations promulgated by the Council on Environmental Quality. ERT reviews all CFSAN actions, such as approvals of food and color additive petitions, allowing a food contact notification to become effective, and issuance of regulations, and makes sure that the environmental impact of these actions is addressed either in a claim of categorical exclusion or in an environmental assessment.

References & Footnotes
1. Anna P. Shanklin, Ph.D. and Elizabeth R. Sánchez, Ph.D.. Regulatory Report: FDA’s Food Contact Substance Notification Program. Food Safety Magazine. October/November 2005.
2. Codified in 40 CFR 1500-1508.
3. FFDCA Section 409(h).
4. Definition codified in 21 CFR 25.15.
5. www.cfsan.fda.gov/~dms/opa2eg.html#partii
6. www.cfsan.fda.gov/~dms/opa2eg.html
7. www.cfsan.fda.gov/~rdb/opa-envt.html