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Draft Guidance for Environmental Risk Assessment for Veterinary Medicinal Products: Aquatic Exposure

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Title: Draft Guidance for Environmental Risk Assessment for Veterinary Medicinal Products: Aquatic Exposure


1
Draft Guidance for Environmental Risk Assessment
for Veterinary Medicinal Products Aquatic
Exposures
  • Joint Subcommittee on Aquaculture
  • Quality Assurance Working Group
  • Washington, DC
  • December 3, 2003
  • Charles E. Eirkson III, HFV-103,
  • 301-827-8561
  • ceirkson_at_cvm.fda.gov

2
National Environmental Policy Act (NEPA)
  • Categorical Exclusion
  • Environmental Assessment
  • Environmental Impact Statement

3
  • Existing Environmental Guidance
  • 21 CFR Part 25 - FDA Environmental Considerations
  • FDA Approval of New Animal Drugs for Minor Uses
    and for Minor Species - CVM Number 61
  • Environmental Impact Assessments (EIA'S) for
    Veterinary Medicinal Products (VMP'S)- PHASE I
  • - CVM Guidance Number 89
  • Organization for Economic Cooperation and
    Development (OECD) Guidelines for the Testing of
    Chemicals

4
Guidance for Industry FDA Approval of New
Animal Drugsfor Minor Uses and for Minor
SpeciesNumber 614/99
  • ENVIRONMENTAL CONSIDERATIONS general and
    regulatory
  • the content and format of an EA for veterinary
    drugs
  • Guidance for performing an environmental risk
    analysis - format

5
Content and format of an EA for veterinary drugs
  • date, name, and address of the applicant
  • description of the proposed use (including
    disposal)
  • ID of the substances that are subject of the use
  • description of the ecosystem at the site of
    introduction
  • analysis section (analysis of the fate and
    effects)
  • risk characterization based upon the exposures
    and the hazards
  • description of any alternatives (including
    mitigations)
  • preparers names
  • signature block of responsible individual
  • references
  • Appendices

6
Critical portions of the EA are 4, 5, 6, and 7.
  • 4) description of the ecosystem at the site of
    introduction (including a conceptual model with
    assessment endpoints of the potential impacts at
    exposed sites in the environment)
  • 5) analysis section (analysis of the fate and
    effects)
  • 6) risk characterization based upon the
    exposures and the hazards (derived from the
    conceptual model and analysis of the fate and
    effects information)
  • 7) description of any alternatives (including
    mitigations)

7
Data sources literature and laboratory
  • Laboratory studies - GLP
  • Literature 3 independent peer review sources
    with similar endpoint results

8
Guidance for environmental risk analysis includes
  • Baker, J.L., et al., editors. 1994. Aquatic
    Dialogue Group Pesticide Risk Assessment and
    Mitigation. SETAC Press, Pensacola, FL.
  • 2. Cockerham, Lorris and Shane, Barbara, editors.
    1994. Basic Environmental Toxicology. CRC, Boca
    Raton, FL.
  • 3. Environmental Protection Agency. Proposed
    Guidelines for Ecological Risk Assessment. the
    FEDERAL REGISTER of September 9, 1996 (61 FR
    47552).
  • 4. Suter, G.W. 1993. Ecological Risk Assessment.
    Lewis Publishers, Boca Raton, FL.

9
  • Guidance for Industry
  • ENVIRONMENTAL IMPACT
  • ASSESSMENTS (EIA'S)
  • FOR VETERINARY MEDICINAL PRODUCTS (VMP'S)-
  • PHASE I
  • VICH GL6
  • Final Guidance
  • March 7, 2001

10
Phase I
  • Risk screen based on environmental exposures
  • VMP's with limited use and limited environmental
    exposure management methods
  • Phase I also identifies VMP's that may need a
    more extensive EIA under Phase II
  • identifies VMP's that need additional
    environmental information to address particular
    concerns
  • Provides a default concentration of 1 ppb for
    requiring additional data in Phase II for aquatic
    exposures
  • Follows our categorical exclusions in 21 CFR Part
    25.33 (http//www.access.gpo.gov/cgi-bin/cfrassemb
    le.cgi?title200221)

11
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12
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13
VICHENVIRONMENTAL IMPACT ASSESSMENTS (EIAs) FOR
VETERINARY MEDICINAL PRODUCTS (VMPs) - PHASE II
DRAFT GUIDANCE
  • December 2002 Version

14
Phase II
  • Specific studies
  • Tier A
  • Tier B
  • Decision-making criteria within and between
    tiers
  • Risk Quotient Method
  • Predicted Environmental Concentration (PEC)
  • Predicted No Effect Concentration (PNEC)
  • Assessment (safety) factors (AF)
  • Still a risk screen that includes exposure and
    effects

15
Ecological and Assessment Endpoint
  • Exposures generally in
  • Water
  • Soil / Sediment
  • Exposure to and concern for
  • Invertebrates
  • Plants
  • Vertebrates
  • Microbial functioning

16
Tier A Physical-chemical Tests
  • Test Guideline
  • Water Solubility OECD 105
  • Dissociation Constant OECD 112
  • UV-Visible Spectrum OECD 101
  • Melting Temperature OECD 102
  • Vapour Pressure (calc only) OECD 104
  • n-Octanol/Water Partition OECD 107/117

17
Tier A Environmental Fate Studies
  • Test Guideline
  • Adsorption/Desorption OECD 106
  • (soil and/or sediment)
  • Soil Biodegradation OECD 307
  • Aquatic Degradation in OECD 308
  • Photolysis (optional) Seek guidance
  • Hydrolysis (optional) OECD 111

18
Tier A Aquatic Effects Studies
  • Tests Endpoint AF Guidelines
  • Freshwater
  • Algal growth EC50 100 OECD 201
  • Daphnia EC50 1000 OECD 202
  • Fish acute LC50 1000 OECD 203
  • Seawater
  • Algal growth EC50 100 ISO 10253
  • Crustacean acute EC50 1000 ISO 14669
  • Fish acute LC50 1000 Seek guidance

19
Risk Quotient (RQ) Approach
  • PEC/PNEC ratio
  • where
  • PEC predicted environmental concentrations
  • PNEC predicted no-effect on non-target
    organisms
  • PNEC is derived from the toxicity endpoint
    divided by the AF
  • Assessment Factors (AF) - numerical factor that
    is applied to the endpoint value of an effects
    study to derive a predicted no-effect
    concentration (PNEC)

20
Application Factor
  • Follow standard toxicology factor setting
  • Inter/intra species 10
  • Laboratory to field 10
  • Acute to chronic 10
  • Results in AF ranging from 1 to 1000

21
PEC Refinement at Tier B
  • metabolism/excretion information
  • biodegradation in soil/aquatic systems
  • use of regional values for the parameters in the
    PEC estimation equations

22
Criteria to go to Tier B testing
  • Triggers Testing
  • RQ ?1 Chronic toxicity for affected species
  • logKow ? 4 Bioconcentration test in fish
  • If RQ for aquatic invertebrate?1 then do
    PECsediment/PNECaquatic invertebrate
  • If RQ?1, then toxicity test in sediment species
    in Tier B
  • (if log Kow ?5, then the AF for aquatic
    invertebrate is increased by 10)

23
Tier B Testing
  • No additional physical-chemical tests

24
Tier B Aquatic Effects Studies
  • Tests Endpoint AF Guidelines
  • Freshwater
  • Algae growth inhibition NOEC 10 OECD 201
  • Daphnia magna reproduction NOEC 10 OECD 211
  • Fish, early-life stage NOEC 10 OECD 210
  • Sediment Invertebrate EC50 10 OECD 218,
    219
  • Seawater
  • Algae growth inhibition NOEC 10 ISO 10253
  • Crustacean chronic NOEC 10 Seek guide
  • Fish chronic NOEC 10 Seek guide
  • Sediment Invertebrate EC50 10 Seek guide

25
PEC Surface Water (SW-initial)
  • total amount of VMP used in within the
    consecutive administration period for one
    treatment
  • volume of the aquatic environment within a
    defined distance of the treatment area which is
    determined regionally
  • assumption that the VMP is diluted within the
    system (dependent on practices), and then
    introduced into the wider environment
  • for a partially closed system, depends on
    dilution within the facility and upon release as
    determined regionally and
  • for an open system, the extent of dilution is
    dependent on the shape, width and depth of the
    cultured area and water movement.

26
PECsediment
  • PECsediment
  • PECsurfacewater X Kd
  • Where
  • PECsurfacewater is in (mg/L)
  • Kd soil-water partitioning coefficient
  • consider uneaten feed

27
PEC calculations regional variables
  • Surface water
  • facility size and operation
  • size of mixing zone
  • shape, width and depth of the cultured area
  • number of pens treated
  • water movement
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