The Council on Environmental Quality (CEQ) released a Final Guidance on Greenhouse Gases and Climate Change in August 2016, which recommends, among other things, that federal agencies quantify greenhouse gas (GHG) emissions in documents required under the National Environmental Policy Act (NEPA), such as Environmental Assessments (EAs) for Food-Contact Substances (FCSs). The new information that the U.S. Food and Drug Administration (FDA) is now requesting on food-contact notification (FCN) submissions as a result of the guidance was addressed by Suzanne Hill, a Supervisory Biologist in FDA’s Center for Food Safety and Applied Nutrition, at the Keller and Heckman Food Packaging Law Seminar, held October 19-20, 2016, in Arlington, VA.

By way of background, NEPA requires all federal agencies to consider environmental factors in decision-making. It also established CEQ, which was charged with overseeing NEPA implementation. Consequently, a FCN must contain information to address FDA’s responsibility under NEPA, in the form of either an FCN or a claim of categorical exclusion (CATEX). If the environmental component of a FCN is missing or deficient as defined under Title 21 of the Code of Federal Regulations (C.F.R.) Section 25.40, the agency will not accept the notification for review, Ms. Hill explained.

An EA is a “concise public document that serves to provide sufficient evidence and analysis for an agency to determine whether to prepare an Environmental Impact Statement or a Finding of No Significant Impact (FONSI)” (See 40 C.F.R. Section 1508.9 and 21 C.F.R. Section 25.40(a)).  FDA has promulgated regulations that categorically exempt from EA requirements classes of actions that do not have a significant effect on the human environment. An EA is required if a CATEX does not exist, or if extraordinary circumstances exist. Extraordinary circumstances include: potential for serious harm to the environment, adverse effects on species or habitat of federally protected species, and when uncertainty or unique risks are involved. The submission of a CATEX claim must contain sufficient information for the reviewer to determine if the claim is warranted, Ms. Hill told attendees.

Ms. Hill discussed some of the CATEXs that apply to FCNs (see 21 C.F.R. Section 25.32). The most commonly claimed CATEX is for non-coating uses in which the additive is a component of a finished food-packaging material and it does not contribute more than 5% by weight to the finished food-packaging material and it remains with the packaging through use and disposal by the consumer, she said. Other CATEXs include: substances that are a component of a food-contact surface (i.e., countertops, water filters) or articles intended for repeat use (i.e., lubricant for equipment); and FCSs registered by the Environmental Protection Agency under The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for the same use requested in the notification.

Greenhouse Gas Emissions

As mentioned above, in some cases, FDA has required additional information as a result of CEQ’s recently released guidance on GHG emissions. CEQ defines GHGs as: carbon dioxide, methane, nitrous oxide, hydrofluorcarbons, perfluorocarbons, nitrogen trifluoride, and sulfur hexafluoride. The common unit of measurement for GHGs is metric tons of CO2 equivalent (CO2-e). Ms. Hill summarized CEQ’s final guidance related to GHG emissions in NEPA documents as follows:

• Recommends that agencies quantify a proposed agency action’s projected direct and indirect GHG emissions, taking into account available data and GHG quantification tools that are suitable for the proposed action;

• Recommends that agencies use projected GHG emissions (to include, where applicable, carbon sequestration implications associated with the proposed agency action) as a proxy for assessing potential climate change effects when preparing a NEPA analysis for a proposed agency action;

• Recommends that where agencies do not quantify a proposed agency action’s projected GHG emissions because tools, methodologies, or data inputs are not reasonably available to support calculations for a quantitative analysis, agencies include a qualitative analysis in the NEPA document and explain the basis for determining that quantification is not reasonably available;

• Counsels agencies that “rule of reason” inherent in NEPA and the CEQ Regulations allows agencies to determine, based on their expertise and experience, how to consider an environmental effect and prepare an analysis based on the available information.

The final guidance does not include the annual 25,000 metric tons carbon dioxide equivalent (CO2-e) threshold that was in the draft guidance; however, Ms. Hill informed attendees that that threshold still applies because it is the reporting threshold for municipal solid waste (MSW) combustion facilities. She also noted that, in general, the GHG emissions that would occur from disposal of a food-contact material are related to combustion in MSW combustion facilities.  Finally, Ms. Hill explained that future revisions to CATEX will need to consider GHG emissions.