EcotoxicologyandCFR1 58

Slide1: 

Ecotoxicology and CFR 158 Wildlife International, Ltd.

Slide2: 

Wildlife International, Ltd. What’s New? Affirmation of policy Sections 158.100 – 158.130

Slide3: 

What’s Different? Risk assessment Product stewardship Specialty studies Wildlife International, Ltd.

Slide4: 

Wildlife International, Ltd. Global Regulations

Slide5: 

The following provide our overview of current testing issues, endpoints and their regulatory impact. Wildlife International, Ltd.

Slide6: 

Aquatic Toxicology Standardized tests Non-standardized tests Wildlife International, Ltd.

Slide7: 

Many of our longer-term studies now have endocrine mediated endpoints used to assess potential endocrine disruption. Development Fecundity Histopathology Vitellogenin Other The EPA and EU are rapidly developing and validating Tier I and Tier II tests to evaluate endocrine disruption in aquatic, avian and amphibian populations. Wildlife International, Ltd. Aquatic Endocrine Disruptor Issues

Slide8: 

Non-Standard Testing Sediment toxicity Aquatic macrophytes Dosing for difficult to test materials Insoluble Volatile Binding Wildlife International, Ltd.

Slide9: 

Amphibian Issues For whatever reasons, worldwide amphibian populations appear to be declining Several agrochemicals have come under scrutiny for their potential of impacting amphibian populations Conducting amphibian development studies using Xenopus sp. with histological and thyroid endpoints. We expect the regulatory authorities to expand this type of testing in the future Other species may also be evaluated (i.e., Rana sp., lizards, salamanders) Wildlife International, Ltd. New Tests

Slide10: 

Bioconcentration in Fish We are evaluating new approaches for measuring bioconcentration of agrochemicals in fish species. Using kinetic methods to shorten test, use fewer animals and reduce costs. Combining tests (e.g., fish early life stage study and bioconcentration endpoints, reducing costs and test animals). Fish metabolism tests using single fish to evaluate bioconcentration, distribution and metabolism. Another option is to evaluate uptake via diet. Wildlife International, Ltd.

Slide11: 

Wildlife International, Ltd.

Slide12: 

New requirement to include passerine species for LD50 (redwing blackbird suggested) Major problem! The redwing is a migratory bird and is protected by law (a pest in some areas, a treasure in others) Must obtain permits from FWS to collect and test, which have not been regularly issued Seasonal availability Disease potential in wild-caught birds Diseases transmitted to other birds and mammals Human health risks (i.e., avian flu, West Nile virus) Alternative species that can be raised (Zebra finch) or held in captivity (house sparrow) may be more suitable Wildlife International, Ltd. Avian Toxicology

Slide13: 

Avian Toxicology Reproduction study requirements: Once field studies were no longer required, avian reproduction studies with bobwhite and mallards became a routine requirement Wildlife has conducted over 400 avian reproduction studies and is at the forefront working with various study groups to develop meaningful studies that provide useable answers to regulatory questions. Endocrine disruptor endpoints Avian avoidance tests Designed to evaluate a species’ aversion to specific smells, colors, etc., to reduce risk Wildlife International, Ltd.

Slide14: 

Wildlife International, Ltd. Continuation of existing EPA policy Test material changing TGAI to TEP Elimination of seed germination, but such studies haven’t been conducted in years EPA – 10 species required OECD – 6 species required Plant Studies – Subdivision J

Slide15: 

Plant Studies – Subdivision J Wildlife International, Ltd.

Slide16: 

So What Has Changed? Wildlife International, Ltd. Evaluation of endpoints other than lethality More specific and sophisticated endpoints Studies designed to evaluate specific questions required for meaningful risk assessment Looking at environmental endpoints that weren’t a concern when original FIFRA was implemented Endocrine disruption Population effects Sediment toxicity/amphibian concerns You won’t find these issues in the pages of CFR 158, but trust me, the questions are being asked, and you will be responsible for providing the data