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EPAA Annual Conference 2007 Regulatory Acceptance and Implementation of 3Rs approaches Challenges for industry and regulators Dr. Hennicke Kamp BASF Aktiengesellschaft. Challenges for Industry - global regulatory acceptance . Global regulatory acceptance - a must in a globalized world .

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EPAA Annual Conference 2007

Regulatory Acceptance and Implementation of 3Rs approaches

Challenges for industry and regulators

Dr. Hennicke Kamp

BASF Aktiengesellschaft


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Challenges for Industry

- global regulatory acceptance

Global regulatory acceptance

- a must in a globalized world

  • Industry acts globally

  • products usually sold in different regions

  • product safety has to satisfy regional demands

  • studies for safety assessment have to be accepted in these regions(preferably globally)

  • international guidelines (OECD, ICH,...)

  • Consequence

  • If different testing requirements exist in different regions

  • requirements will need to be addressed

  • different tests will be conducted for different regions

  • duplication of efforts and unnecessary use of animals


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Challenges for industry

- the Local Lymph Node Assay

  • Local Lymph Node Assay (LLNA)

  •  OECD 429

  •  sensitization

  •  animal test performed in mice

  • replaces tests in guinea pigs

  •  Refinement, potential reduction

Test principle

 repeated application of test substance (ear)

 measurement of cell proliferation in local lymph node

 incorporation of radioactively labeled substrates

 cell number in lymph node


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Challenges for industry

- the Local Lymph Node Assay

  • Local Lymph Node Assay: Acceptance

  • EU  accepted

  • UK assessment of „pooled“ values from 4 animals mandatory  accepted in EU

  • U.S. assessment of individual animals (5 - 6)  study protocol not permitted in UK requirement of positive control

Consequence

 LLNA cannot be conducted in UK if data needed for registration in US

 LLNA performed using more animals for U.S. compared to EU


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Challenges for industry

- the Local Lymph Node Assay

  • Local Lymph Node Assay: agrochemical formulations

  • LLNA originally not developed for formulations

  • scientifically sound for formulations

  • protocol for aqueous formulations developed by ECPA group (BASF, Bayer, DOW, Syngenta)

  • EU  accepted in EU

     preferred for formulations

  • U.S.  not accepted  Buhler test (guinea pig) preferred for formulations (not accepted in EU)

Consequence:

 LLNA for formulations for registration in EU

 guinea pig test performed for registration in US  more animal testing instead of less


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Challenges for industry

- Dermal Penetration In Vitro

Dermal Penetration In Vitro

 OECD 428

 Test substance penetration via skin

 explanted skin

 Replacement

Test principle

 application of test substance on skin surface

 measurement of test substance penetrating through the skin


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Challenges for industry

- Dermal Penetration In Vitro

  • Dermal Penetration In Vitro: Acceptance

  • EU  accepted  preferred method

  • U.S.  not accepted

Consequence:

 Dermal Penetration In Vitrofor registration in EU

In addition

 Dermal Penetration In Vivofor registration in US


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Challenges for industry

- Studies performed in dogs

Studies performed in dogs

 mandatory as non-rodent species for agrochemicals

 relevant for risk assessment

 acute, sub-chronic, chronic (1 year)

  • chronic dog study:

  •  OECD 452 32 animals

  •  risk assessment based on 90 day study feasable

  •  waiving possible

  •  Reduction


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Challenges for industry

- Studies performed in dogs

  • Chronic dog study - waiving: Acceptance

  • EU  waiving accepted  not mandatory in revised 91/414

  • U.S.  waiving possible after case-by-case discussion (U.S. EPA)

     California: waiving not possible Brazil, Japan: situation unclear

Consequence:

 study performed for worldwide registration


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Conclusion

  • global acceptance of methodologies is important for industry

  • examples where alternative approaches are not accepted in some regions:

     Local Lymph Node Assay  Dermal Penetration In Vitro

     Studies performed in dogs

  • not only a transatlantic issue

  • acceptance of negative results of alternative methods  big impact on animal welfare  prerequisite: high negative predictivity