GUIDANCE DOCUMENT
Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN - Attachment 1 May 2006
September 2003; Revised May 2006
Main Document Table of Contents
| SECTION | DESCRIPTION |
|---|---|
| 1.00 | FOREWORD |
| 2.00 | STEP-BY-STEP GUIDANCE FOR PREPARING ENVIRONMENTAL ASSESSMENTS |
| 3.00 | TECHNICAL ASSISTANCE DOCUMENTS--ENVIRONMENTAL FATE TESTING |
| 3.01 | Water Solubility |
| 3.02 | n-Octanol/Water Partition Coefficient |
| 3.03 | Vapor Pressure |
| 3.04 | Dissociation Constant |
| 3.05 | Ultraviolet-Visible Absorption Spectrum |
| 3.06 | Melting Temperature |
| 3.07 | Density and Relative Density |
| 3.08 | Sorption and Desorption |
| 3.09 | Hydrolysis |
| 3.10 | Photodegradation |
| 3.11 | Aerobic Biodegradation in Water |
| 3.12 | Aerobic Biodegradation in Soil |
| 4.00 | TECHNICAL ASSISTANCE DOCUMENTS--ENVIRONMENTAL EFFECTS TESTING |
| 4.01 | Algal Assay |
| 4.02 | Microbial Growth Inhibition |
| 4.03 | (Reserved) |
| 4.04 | (Reserved) |
| 4.05 | (Reserved) |
| 4.06 | Seed Germination and Root Elongation |
| 4.07 | Seedling Growth |
| 4.08 | Daphnia Acute Toxicity |
| 4.09 | Daphnia Chronic Toxicity |
| 4.10 | Hyalella azteca Acute Toxicity |
| 4.11 | Freshwater Fish Acute Toxicity |
| 4.12 | Earthworm Subacute Toxicity |
| 5.00 | TECHNICAL ASSISTANCE DOCUMENTS--CALCULATIONS |
| 5.01 | Acute Toxicity Calculations |
| 5.02 | Analysis of Variance and Tests of Differences Between Group Means |
This Environmental Assessment Technical Handbook is available from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161. The telephone number is (703) 605-6000. The NTIS order number is PB 87-175345/AS. Price codes are A17 for paper copy and A01 for microfiche; call for the current prices.
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:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.