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Environmental Assessments Human and Animal Drugs

Environmental Assessments Human and Animal Drugs. Nancy Sager Center for Drug Evaluation and Research Food and Drug Administration. Federal Food, Drug, and Cosmetic Act (FFDCA) National Environmental Policy Act (NEPA) FDA regulations implementing NEPA (21 CFR Part 25) revised in 1997

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Environmental Assessments Human and Animal Drugs

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  1. Environmental AssessmentsHuman and Animal Drugs Nancy Sager Center for Drug Evaluation and Research Food and Drug Administration

  2. 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) Statutory Framework

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

  4. 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 Categorical Exclusion Examples

  5. Approval of a drug when the approval will not increase the use of the drug Withdrawal of approval of a drug Categorical ExclusionExamples

  6. 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 Categorical ExclusionExamples

  7. 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) Environmental Impact Statement

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

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

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

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

  12. photolysis hydrolysis biodegradation Fate: Depletion Mechanisms

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

  14. 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 Differences: Environmental Compartment

  15. 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 Differences: Cut-offs

  16. 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) 1 ppb (Aquatic)

  17. Retrospective Review of Ecotoxicity Data Center for Drug Evaluation and Research (CDER) 0.001 0.1 0.2 0.03 0.4 0.5 0.6 0.7 0.8 0.9 1 100 200 300 400 500 600 700 800 900 1000 Toxicity test result (ppm)

  18. 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 100 ppb (Soil)

  19. 21 CFR Part 25 (FDA regulations implementing NEPA) 40 CFR Parts 1500-1508 (NEPA regulations) Retrospective Review of Ecotoxicity Data Submitted in Environmental Assessments available under FOI from Public Docket No. 96N-0057 Sources of Information

  20. FDA’s guidance on Environmental Assessment of Human Drug and Biologics Applications (July 1998) available at http://www.fda.gov/cder/ guidance/index.htm FDA’s guidance on Environmental Impact Assessments (EIAs) for Veterinary Medicinal Products (VMPs); VICH GL6 (March 7, 2001) available at http://www.fda.gov/cvm/guidance/guide89.doc Sources of Information

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

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