U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN - Attachment 2
  1. Regulatory Information

GUIDANCE DOCUMENT

Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN - Attachment 2 May 2006

Final

Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN - Attachment 2

Issued by:
Guidance Issuing Office
Office of Food Additive Safety

Main Document Table of Contents

Physical/chemical characterization
Water Solubility  
Dissociation Constant(s)  
Octanol/Water Partition Coefficient (Log Kow)  
Vapor Pressure or Henry's Law Constant  
Depletion mechanisms
Sorption/Desorption (Koc)  
Hydrolysis  
Aerobic Biodegradation  
Soil Biodegradation  
Photolysis  
Metabolism  
Environmental effects1
Microbial Inhibition  
Acute Toxicity  
Chronic Toxicity  

1Identify organism(s) and report results, e.g., NOEL, MIC, EC50, LC50.

(Return to Appendix A Section 7)
(Return to Appendix A Section 8)

(Return to Appendix B Section 7)
(Return to Appendix B Section 8)

(Return to Appendix C Section 7)
(Return to Appendix C Section 8)


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


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.