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Environmental Assessments Human and Animal Drugs Nancy Sager Center for Drug Evaluation and Research Food and Drug Administration.

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Presentation on theme: "Environmental Assessments Human and Animal Drugs Nancy Sager Center for Drug Evaluation and Research Food and Drug Administration."— Presentation transcript:

1 Environmental Assessments Human and Animal Drugs Nancy Sager Center for Drug Evaluation and Research Food and Drug Administration

2 Statutory Framework Federal Food, Drug, and Cosmetic Act (FFDCA) National Environmental Policy Act (NEPA) –FDA regulations implementing NEPA (21 CFR Part 25) revised in 1997 Human and animal drugs are exempt from EPA’s Toxic Substances Control Act (TSCA)

3 NEPA Process Categorical Exclusion (CE) –Extraordinary circumstances provision Environmental Assessment (EA) Environmental Impact Statement (EIS)

4 Categorical Exclusion Examples Investigational new (animal) drug applications (IND/INAD) Approval of natural substances when approval does not alter significantly the distribution of the substance, its metabolites or degradation products in the environment

5 Categorical Exclusion Examples Approval of a drug when the approval will not increase the use of the drug Withdrawal of approval of a drug

6 Categorical Exclusion Examples Human drugs: Approval of a drug when the concentration of drug expected to enter the aquatic environment (EIC) is less than 1 ppb Animal drugs: Approval of drugs intended for use in nonfood animals

7 Environmental Impact Statement There are no categories of FDA actions that routinely significantly affect the quality of the human environment and that therefore ordinarily require the preparation of an EIS –FDA has prepared only one EIS directly related to human/animal drug use (CFCs, 1978)

8 Environmental Assessment Issues Human Drugs EIC  1 ppb (ecotoxicity) Use of wild plants/animals (harvesting) –extraordinary circumstances provision

9 Environmental Assessment Issues Animal Drugs Ecotoxicity Feedlots/Poultry Houses/Swine Operations –Confined animal feed operations (CAFOs) Aquaculture Pastured Animals

10 Ecotoxicity Evaluation Fate and Effects Follows standard approaches/test methods (OECD/EPA/VICH)

11 Fate: Physical/Chemical Characterization water solubility dissociation constant octanol/water partition coefficient vapor pressure sorption/desorption properties

12 Fate: Depletion Mechanisms photolysis hydrolysis biodegradation

13 Effects Tiered approach: Generally, acute toxicity testing then chronic if data indicate Typical number of effects studies –Human drugs: 2-4 –Animal drugs: 4-5

14 Differences: Environmental Compartment EAs for human drugs normally focus on the aquatic environment EAs for animal drugs may evaluate fate and effects in the aquatic and terrestrial environments

15 Differences: Cut-offs Human drugs are categorically excluded (CE) if the EIC in the aquatic environment is less than 1 ppb (absent extraordinary circumstances) Animal drugs do not have a CE based on an EIC. However, less information can be provided if EICs are: –less than 1 ppb released from aquaculture facility –less than 100 ppb in soil

16 1 ppb (Aquatic) Data on human drugs routinely demonstrated no effects on relevant standard test organisms at concentration less than 1 ppb Approximately 90% of the toxicity results were 1 ppm or greater; 10% were between 1 ppb and 1 ppm)

17 Toxicity test result (ppm) Retrospective Review of Ecotoxicity Data Center for Drug E valuation and Research (CDER)

18 100 ppb (Soil) 100 ppb is below the level shown to have effects in ecotoxicity studies conducted on earthworms, microbes, and plants for animal drugs in the U.S

19 Sources of Information 21 CFR Part 25 (FDA regulations implementing NEPA) 40 CFR Parts (NEPA regulations) Retrospective Review of Ecotoxicity Data Submitted in Environmental Assessments available under FOI from Public Docket No. 96N-0057

20 Sources of Information FDA’s guidance on Environmental Assessment of Human Drug and Biologics Applications (July 1998) available at guidance/index.htm FDA’s guidance on Environmental Impact Assessments (EIAs) for Veterinary Medicinal Products (VMPs); VICH GL6 (March 7, 2001) available at

21 Sources of Information After approval of the application, Environmental Assessments are available under the Freedom of Information Act


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