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U.S. Department of Health and Human Services

Food

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Appendix D: Preparing an Environmental Assessment for Components of Finished Food-Packaging Material Present at Greater than 5-Percent-by-Weight

September 2003; Revised May 2006

Guidance for Industry
Preparing a Claim of Categorical Exclusion or an
Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition

Below are recommendations for the suggested format and the types of information to submit to the agency in an environmental assessment. An alternative approach may be used if the approach satisfies the requirements of the applicable statutes and regulations.

Appendix D is still under development and will be issued at a later date. In the interim, we recommend that you contact the Office of Food Additive Safety for assistance in submitting the necessary information.

Contact Information: Layla I. Batarseh at (301) 436-1296

E-mail: erg@cfsan.fda.gov

Additional Contact Information

Main Document Table of Contents

The above guidance document supercedes the previous version dated September 2003.

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