In Part nine of our StepLadder Series, we discussed Food Contact Notifications (FCNs) – filings that companies (notifiers) submit to the US Food and Drug Administration (FDA) to request premarket review and authorization for a new or expanded use of a food contact substance (FCS) in one or more food-contact applications. In that article, we stated that:
In accordance with The National Environmental Policy Act of 1969 (NEPA) (Pub. L. 91–190 (1970)), federal agencies – including FDA – are required to evaluate and assess the environmental impacts of their activities. In response, FDA requires under 21 C.F.R. Section 25.40 that notifiers of an FCN either submit an Environmental Assessment (EA) of the potential effects of the use and disposal (but not the production) of the FCS, or submit a justification for a claim of categorical exclusion under one or more appropriately-defined criteria.
This discussion provides further background and information regarding the potential need for an Environmental Assessment, and specific considerations for preparing an EA or a claim of categorical exclusion (exemption) from the need for submitting an EA.
Components of an Environmental Assessment
Environmental Assessments, if required, must address the relevant environmental issues and the potential effects of the use and disposal (but not the production) of the substance and contain sufficient information to enable FDA to determine whether the proposed action may significantly affect the quality of the human environment. The EA document is designed to allow the public to understand the basis for the agency's decision to prepare an Environmental Impact Statement (EIS) or a Finding of No Significant Impact (FONSI). When an EA is required to accompany an FCN submission, a notifier (or its agent) will prepare a document that contains the following information:
- Administrative information (date, name of applicant and address).
- Description of the proposed action.
- Identification of substance(s) that are the subject of the proposed action.
- Information regarding the introduction of the substance(s) into the environment as a result of disposal of the FCS.
- Fate of emitted substances in the environment (air, water and land).
- Environmental effects of related substances.
- Use of resources and energy.
- Mitigation measures (if applicable).
- Alternatives to the proposed action.
- A list of preparers and a certification of truthfulness and accuracy.
Depending on the specific characteristics and the intended use of the substance, the EA may make use of mathematical modeling or calculations to determine the amount of greenhouse gases (GHGs) that may be emitted from introduction and disposal of the substance into the environment. In most instances, an FCS is composed of one or more of the elements carbon, hydrogen, and oxygen. Thus, the combustion products of the FCS may include carbon dioxide, among other GHGs. The carbon content of the FCS, for example, can be used to calculate the potential GHG emissions derived from combustion of the FCS by taking into consideration the actual and estimated market volume in the first and fifth year of production (usually made available to FDA in a Confidential Attachment to the Environmental Assessment). Provided this value is below 25,000 metric tons carbon, and no other significant effects are anticipated to occur in air, water or on land as a result of disposal of the FCS, the notifier may rely on this basis to propose that a "Finding of No Significant Impact"(FONSI) is appropriate for FDA to reach in this case.
Environmental assessments are publicly-available documents that are accessible online.1 FDA also maintains an Environmental Guidance Document on its website to assist notifiers by recommending specific information that may be included in EA submissions.2
Exemptions from the Need for an Environmental Assessment
Specific exemptions from the need for an EA are described in 21 C.F.R. § 25.32 and also appear in FDA's Form 3480, Part IV – Environmental Information. When an exemption is claimed, a notifier must: (1) cite the relevant section(s) of the CFR under which the categorical exclusion is claimed; (2) include a statement of compliance with the categorical exclusion criteria; and (3) include a statement that, to the submitter's knowledge, no extraordinary circumstances exist that require submission of an EA. The most commonly referenced bases for claiming a categorical exemption include:
Use level less than 5% by weight
Submissions for substances that are present in finished food-packaging material at not greater than 5 percent-by-weight and are expected to remain with finished food-packaging material when used as intended by consumers are excluded from the need for an EA under § 25.32(i). Importantly, this exemption does not include non-food packaging uses (e.g., components of cups, plates and cutlery):
25.32(i): Approval of a food additive petition, establishment or amendment of a regulation for a food substance as GRAS under the conditions of its intended use for humans or animals under parts 182, 184, 186, 582, or 584 of this chapter, the granting of a request for exemption from regulation as a food additive under § 170.39 of this chapter, or allowing a notification submitted under 21 U.S.C. 348(h) to become effective, 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.
Repeated-Use Applications
Certain FCSs used in the production of food-contact materials may qualify for exclusion under § 25.32(j) because they are intended for repeated-use (e.g., more than one time) applications.
25.32(j) Approval of a food additive petition, establishment or amendment of a regulation for a food substance as GRAS under the conditions of its intended use for humans or animals under parts 182, 184, 186, 582, or 584 of this chapter, the granting of a request for exemption from regulation as a food additive under § 170.39 of this chapter, or allowing a notification submitted under 21 U.S.C. 348(h) to become effective, when the substance is to be used as a component of a food-contact surface of permanent or semi-permanent equipment or of another food-contact article intended for repeated use.
FIFRA Registration
The exclusion under § 25.32(q) applies to a substance that already has been registered by the US Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for the same food-contact use requested in the FCN submission to FDA.
25.32(q) - Approval of a food additive petition, the granting of a request for exemption from regulation as a food additive under § 170.39 of this chapter, or allowing a notification submitted under 21 U.S.C. 348(h) to become effective for a substance registered by the Environmental Protection Agency under FIFRA for the same use requested in the petition, request for exemption, or notification.
The development of an EA, or the determination that an exemption applies, can be a complex process. Therefore, the use of counsel with specific experience preparing these types of documents is strongly suggested.
Footnotes
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
