# Presentation: 604934

## FDA Workshop on the Notification for Food Contact Substances: Environmental Requirements for Food Contact Notifications (FCNs)

- Dr. Paul C. DeLeo
- Division of Chemistry Research and Environmental Review
- Office of Food Additive Safety
- Food and Drug Administration
- October 15, 2002

## OVERVIEW

- Background on NEPA
- Why FCNs are subject to NEPA
- Environmental requirements for FCNs
- environmental assessments (EAs)
- categorical exclusions from EAs
- Form 3480

## Background on the National Environmental Policy Act (NEPA)

## NEPA

- NEPA requires Federal agencies to take _environmental considerations_ into account in their final agency actions.
- NEPA _supplements_ FDA’s authority under the FFDCA and other public health statutes.
- NEPA _does not supersede_ these statutes.
- NEPA does not require agency decisions to favor environmental protection over other considerations, such as human health.
- FDA’s NEPA regulations are found in 21 CFR Part 25.

## NEPA – continued

- NEPA is a full disclosure act
- The complete environmental record open to the public.
- Public involvement is encouraged.
- NEPA is a broad statute
- Requires consideration of all aspects of actions which may have an impact on man's environment, including impacts on natural resources and energy use.
- Applies to actions which may have impacts abroad.

## NEPA – continued

- All agencies of the Federal Government shall include an environmental impact statement (EIS) with every major Federal action _significantly affecting the quality of the human_ _environment_.
- Environmental assessments (EAs) are prepared to help determine if an action will significantly affect the quality of the human environment, and thus require an EIS.

## Why FCNs are subject to NEPA

## Why FCNs are subject to NEPA?

- FDA’s analysis of the applicability of NEPA to the FCN process is found in
- 65 FR 30352 (May 11, 2000).

## NEPA and the FCN process

- NEPA requires agencies to consider the environmental impacts for actions that are _major_ and _final_.

## NEPA and the FCN process: Major Actions

- Regulations implementing NEPA define _major_ agency actions as those which “...include the circumstances where the responsible official fails to act (by not objecting, in this case) and that failure is reviewable by courts...under the Administrative Procedure Act (APA); i.e., it is subject to judicial review (see 40 CFR 1508.18).”

## NEPA and the FCN process: Finality

- 	The agency’s decision “not to object” meets _finality_ requirements under the APA as recently articulated by the Supreme Court *(Bennett* v. *Spear*, 520 U.S. 154, 177 (1997)).
- It “marks the consummation of the agency’s decision making process”: by not objecting, the agency can be considered to have reached its conclusion about the safety of a food contact substance.
- Rights or obligations are determined: authorization for marketing is a “direct and appreciable” legal consequence of the agency’s decision not to object.

## NEPA and the FCN process – cont.

- The agency’s decision not to object is a **major** and **final** action, and therefore, the requirements of NEPA apply to the FCN process.

## Environmental Requirements for FCNs

## NEPA requirements for FCNs

- FCNs must contain _either_:
- An Environmental Assessment (EA), or
- A claim of categorical exclusion from the need to prepare an EA.
- If the environmental component of an FCN is missing or deficient under 21 CFR 25.40, the agency will not accept the notification for review.

## What is a Categorical Exclusion?

- A category of action(s) that the agency has determined do not individually or cumulatively affect the quality of the human environment.
- Ordinarily when an action meets the criteria of a categorical exclusion, neither an EA nor an Environmental Impact Statement (EIS) is required.
- When there are extraordinary circumstances associated with an action, an EA may be required.

## About Categorical Exclusions

- FDA expects most FCNs will be subject to a categorical exclusion.
- To date, about 80% of effective FCNs include a warranted claim of categorical exclusion (89 of 112 effective notifications).
- FDA will determine if a notifier’s claim of categorical exclusion is warranted.

## About Categorical Exclusions – cont.

- If FDA determines that for a given FCN a claim of categorical exclusion is not warranted or extraordinary circumstances exist, the notifier will have to prepare an EA.
- Categorical exclusions for actions pertaining to FDA’s Center for Food Safety and Applied Nutrition are found in 21 CFR 25.32.

## Categorical Exclusions for FCNs

- 21 CFR 25.32(i)
- 21 CFR 25.32(j)
- 21 CFR 25.32(k)
- 21 CFR 25.32(q)
- 21 CFR 25.32(r)

## Categorical Exclusion 21 CFR 25.32(i)

- For a substance that is present in finished food-packaging material at not greater than 5 percent-by-weight _and_ is expected to remain with the finished food-packaging material through use by the consumer, _OR_ when the substance is a component of a coating of a finished food-packaging material.

## Categorical Exclusion 21 CFR 25.32(j)

- A 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 repeat use.

## Categorical Exclusion 25.32(q)

- A substance registered by EPA under FIFRA for the _same use requested_; i.e., an antimicrobial.

## Claiming Categorical Exclusion

- A claim of categorical exclusion should cite the section of the CFR under which the exclusion is claimed [e.g. 21 CFR 25.32(i)];
- should include a statement of compliance with the exclusion criteria; and
- shall state that no extraordinary circumstances exist that require submission of an EA.

## Form 3480 – Categorical Exclusions

- 25.32(i)

**X**

**X**

## Form 3480 – EAs

**An environmental assessment was prepared under 21 CFR 25.40 and is included in Appendix **_** X**__**	**_**.**_** **_

## What is an EA?

- A concise public document that serves to provide sufficient evidence and analysis for determining whether the Agency should prepare a Finding of No Significant Impact (FONSI) or an Environmental Impact Statement (see 40 CFR 1508.9).

## About EAs for FCNs

- EAs are prepared by the notifier, with recommendations from FDA, when needed.
- The determination as to whether to prepare a Finding of No Significant Impact (FONSI) or an Environmental Impact Statement (EIS) is made by FDA.

##  When is an EA Required?

- Macronutrient replacements that are expected to remain with the food.
- Substances used in food production that are not intended to remain with food (Secondary Direct Food Additives).
- Processing aids used in food-packaging that do not remain with the packaging.
- Components of food-packaging at >5%.

## Extraordinary Circumstances

- 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.

## What are Extraordinary Circumstances?

- Actions for which there is the potential for serious harm to the environment
- Actions that adversely affect endangered or threatened species
- Actions that threaten a violation of law
- Unique emissions circumstances
- Actions that may have a significant effects on solid waste management, or resource and energy use

## Typical Impacts Assessed in EAs

- The effects of chemical releases to the environment
- The impact of new food-packaging materials on resource and energy use including solid waste management practices; i.e., recycling, landfilling or incineration

## Suggestions for Preparing an EA

- A discussion of the need for the action
- Description of introductions of the substance into the environment
- Information on fate & effects of the substance, and/or impacts on solid waste management
- Alternatives to the proposed action
- Environmental impacts of the proposed action

- _Environmental Assessments should contain_:

## Fate and Effects Data

- There is no specific data requirement in the NEPA regulations.
- However, it is usually necessary that a notifier provide either actual data or results from prediction models to demonstrate there is no significant impact to the environment.
- We recommend that notifiers contact OFAS before conducting any environmental testing.

## Fate and Effects Data – cont.

- Physical/Chemical properties:
- water solubility
- octanol/water partition coefficient
- vapor pressure/Henry’s Law constant
- Depletion mechanism data:
- hydrolysis, photolysis
- aerobic and/or anaerobic biodegradation
- adsorption coefficient
- Effects data: typically aquatic toxicology

## Environmental Prediction Models

- http://www.epa.gov/opptintr/software.htm

## Estimation Software

- http://esc.syrres.com/interkow/estsoft.htm

## EPA’s EPI Suite Estimation Software

**http://www.epa.gov/oppt/exposure/docs/episuitedl.htm**

## ECOSAR

**http://www.epa.gov/opptintr/newchems/21ecosar.htm**

## Polymeric Food-Packaging Material: Resource & Energy Use

- Will be discussed as part of afternoon session on environmental issues immediately following lunch.

## Summary

- FCNs are required to have an environmental assessment (EA) or a claim of categorical exclusion.
- The categorical exclusions which have been applied most frequently are 21 CFR 25.32(i) and 21 CFR 25.32(j).
- An EA may be needed for an action meeting categorical exclusion criteria if there are extraordinary circumstances.
- When you are not sure about the environmental requirements for your FCN, contact OFAS for guidance.
- OFAS will provide you with recommendations for preparing an environmental assessment for your FCN.