## Clare Thorp, Ph.D. Senior Director Human H ealth Policy 

### CropLife America 

# FIFRA SAP May 21
- 23 2013: EDSP Tier 1 Screening Assays and Battery Performance

### • A not
- for
- profit national trade organization representing the nation’s developers, manufacturers, formulators and distributers of plant science solutions for agriculture and pest management in the U.S.

• Member companies produce, sell and distribute virtually all the crop technology products used by American farmers.

• Member companies have generated the data being assessed by this SAP

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# CropLife America

# Current Pesticide Testing and Regulation

A new pesticide product takes ~10 years to develop. Regulatory testing involves 110+ tests per compound to meet the data requirements necessary for registration. Pesticide testing is as extensive than that conducted for pharmaceuticals Every pesticide currently registered in the US undergoes review every 15 years. EPA can require further testing when more data is required. Tier 1 battery:

 $750k

- $1m per compound

 2+ years to complete

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# The data requirements cover:

• Product performance

• Biological efficacy

• Plant health

• Physical and chemical characteristics

• Wildlife and aquatic organisms ( Ecotox )

• Non
- target organisms

• Environmental fate

• Mammalian toxicology

• Residue chemistry

• Spray drift

• Re
- entry Protection 4

# Toxicological testing:

• Acute:

 Single exposure,

 High dose,

 Short duration (lethal)



### • Sub Chronic :

 Repeated exposure,

 Intermediate Dose,

 Moderate Duration (sub lethal

– toxic and non toxic doses)



### • Chronic:

 Multiple exposures,

 Low dose,

 Long duration (multi generational) 5

## Mammalian Toxicology Data Requirements (global)
Acute Toxicity:

• Oral

• Dermal

• Inhalation

• Skin irritation

• Eye irritation

• Skin sensitization Repeat Dose Toxicity:

• Rangefinders (rat, mouse, dog)

• 90
- day oral rat

• 90
- day oral mouse

• 90
- day oral dog

• 28
- day dermal

• 28/90
- day inhalation Long
- term Toxicity:

• 2
- year rat

• 18
- month mouse

• 1
- year dog Reproduction & Development:

• 2 Generation reproduction

• Rat developmental toxicity

• Rabbit developmental toxicity Acute :

• Oral

• Dermal

• Inhalation

• Skin irritation

• Eye irritation

• Skin sensitization Neurotoxicity:

• Acute neurotoxicity

• Subchronic neurotoxicity

• Developmental Neurotoxicity (conditional) Immunotoxicity:

• Rat and/or mouse immunotoxicity Metabolism:

• ADME single and multiple Other:

• Additional studies as necessary to address specific findings (e.g., mode of action, relative sensitivity)7 Required for global pesticide registration: Avian Toxicity:

• Acute oral (2 species)

• Acute dietary (2 species)

• Reproduction (2 species) Toxicity to Aquatic Organisms:

• Acute freshwater fish (2 species)

• Acute marine fish

• Early Life stage freshwater fish

• Acute freshwater invertebrate

• Acute saltwater invertebrate

• Chronic freshwater invertebrate

• Acute mollusk(estuarine) Toxicity to Bees:

• Honeybee acute contact toxicity

• Honeybee acute oral toxicity

• Honeybee brood toxicity Toxicity to Non
- Target Plants

• Algae

• Aquatic macrophyte

• Terrestrial plants seedling emergence and vegetative vigor toxicity Additional studies (conditionally required and/or required by other regulatory bodies: )

• Additional avian species

• Additional algal species

• Early Life stage saltwater fish

• Fish bioconcentration

• Fish full life cycle

• Aquatic insect

• Sediment dwelling species

• Toxicity to non
- target insects (2
- 4 species)

• Acute and Chronic Toxicity to earthworms 

# Ecotoxicology Data Requirements Use all existing data to identify potential endocrine activity and to guide the selection of endocrine
- specific tests

 Selective use of Tier 1 assays: Not all 11 assays may be necessary

 Staged testing for chemicals: T o allow decisions to be made on specific assays that may not be required and therefore may be waived. Waivers may be assessed using OSRI.

 Select dose level carefully:

– confounding effects

– overt toxicity

– stress on the model system ( in vitro or in vivo )

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## Towards an integrated testing and evaluation program: Not by rote, but by requirement EPA not issue new Tier 1 screening orders for additional substances (List 2) before the Agency has evaluated the lessons learned from the initial List 1 substances

 EPA deliberately evaluate the Tier 1 screening results, alongside the Tier 1 assays, “functionally equivalent data,” and “other scientifically relevant information” to identify the most effective and efficient path forward

 Certain methods need to be upgraded and their corresponding test guidelines revised prior to issuing new test orders

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## Moving Forward: Suggestions

# Additional Points : Communication Global implications of the EDSP  Continue communicating to the public on all stages of the EDSP  Ensure descriptors of “endocrine disrupters” are consistent across the agency and in line with the EDSP definition

March 2013 CLA/ECPA Meeting

# Thank you for your attention Clare Thorp, Ph.D. Senior Director, Human H ealth Policy 

## cthorp@croplifeamerica.org