encouraging the use and adoption of new methods and … · 2020. 7. 6. · - lnteragency...

Advancing Alternatives to Animal Testing

lnteragency Coordinating Committee on the Validation of Alternative Methods

Agency for Toxic Substances and Disease Registry • Consumer Product Safety Commission • Department of Agriculture Department of Defense • Department of Energy • Department of the Interior • Department of Transportation

Environmental Protection Agency • Food and Drug Administration • National Institute for Occupational Safety and Health National Institutes of Health • National Cancer Institute • National Institute of Environmental Health Sciences Institute • National

Institute of Standards and Technology • Occupational Safety and Health Administration

Encouraging the Use and Adoption of New Methods and Approaches by Federal Agencies

and Regulated Industry Anna Lowit, PhD

EPA Office of Pesticides Programs SACATM MeetingSeptember 6, 2018

- lnteragency Coordinating Committee on the Validation of Alternative Methods

A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety

of Chemicals and Medical Products in the United States

IHTERAGENCY COOR DINA.TINO COMMITTEE ON ™E VALIDATION OF ALTEAAATIVE METHOD$

Keys to Implementation • Provide clear language regarding theacceptance of NAMs


Interim Science Policy: Use of Alternative Approaches for Skin Sensilizalion as a Replacemenl for Laboralory

Animal Tesling

DRAFT FOR PUBLIC COMMENT April 4, 2018

EPA's Office of Chemical Safety and Pollution Prevention:

Office of Pesticide Programs Office of Pollution Prevention and Toxics

EPA Interim Science Policy: Skin Sensitization

• EPA/OPP and OPPT now accept two non-animal defined approaches as alternatives to the LLNA

• Covers pesticide actives ingredients, inerts, and mono-constituent industrial chemicals regulated under TSCA






• Collaborate with international partners tofacilitate global harmonization and regulatory acceptance


The International Cooperation on Alternative Test Methods (ICATM)

• Promote international cooperation in the areas of validation studies, independent peer review, and development of harmonized test methods.

• Participation in Validation Management Teams

• October 2018: Workshop on Validation and Establishing Scientific Confidence


2017 i•~

3Rs IN ACTION

' : . . . .. . .

·-TENTH w r, D rnN r ALTERNATIVES AND ANIMAL USE IN THE LIFE SCIENCES

SEATTLE, WASI I ,;.:;rot. SA AUGUST 20-24 20 7 I.

Workshop on Acute Toxicity Testing (2017)

~50 international participants ICATM Regional Updates:

o US, Europe, Japan, Korea, Brazil

Industry Perspectives: o Current regulatory climate

o GHS ad ditivity calculations

International Harmonization: o OECD coordination

s on o ECVAM perspectiveconfidence a nd v alidation o Cosmetics Europe s kin sensitization c ollaboration


ICCVAM Participation in OECD TG Program • An ICCVAM representative will be attending OECD WNTmeetings as an official US participant, in support of thenational coordinator.

– Began in April, 2018


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International Harmonization

• Standardization of Defined Approaches for Skin Sensitization

• OECD proposal co-led by US,EU, and Canada

• Special OECD-ICATM jointmeeting in December, 2017, hosted by EURL-ECVAM.







• Explore processes to incentivize and promotethe use of NAMs


ICCVAM Communities of Practice Webinars • Opportunity to provide guidance to test method developers andfacilitate collaborations that promote the development of new testmethods

• Convened annually in January

– 2018: Machine Learning in Toxicology: Fundamentals of Application and Interpretation

– 2017: Incorporating Chemical Information: Resources, Limitations, and Characterizing the Domain of Applicability for 21st Century ToxicityTesting

– 2016: Fundamentals of Using Quantitative Structure–Activity Relationship Models and Read-across Techniques in Predictive Toxicology


New Approach Methodology Use for Regulatory Application (NURA):

Integrating new approaches into your TSCA testing

October 1- 2, 2018 Research Triangle Park, NC

Training and Education

• ICCVAM and NICEATM representatives on the draft program

– Bert Hakkinen (NLM)

– Gino Scarano (EPA-OPPT)

– Nicole Kleinstreuer (NIEHS-NICEATM)

– Kamel Mansouri (NICEATM Contractor)

• Regulated industry

– Angus, P&G, Dow


Ongoing Stakeholder Webinar Series • PETA International Science Consortium series of pre-recorded webinars(n=17) focused on alternative approaches for testing the toxicity of inhaled substances

• International experts from industry, government, and non-profit organizations

• In silico models, in vitro test systems, and integrated approaches to testing and assessment

• This series leverages the collective expertise of many of the participants at the PISC and NICEATM co-organized workshop on alternatives for acute inhalation toxicity testing (September 2016)

• https://www.piscltd.org.uk/inhalation-webinars/

https://www.piscltd.org.uk/inhalation-webinars/







• Explore processes to incentivize and promotethe use of NAMs

• Identify appropriate metrics for prioritizingactivities, monitoring progress, and measuring success


Hazard & Science Policy Council (HASPOC)

• Reduce: Waivers for developmental, reproductive, DNT,chronic/carcinogenicity toxicity

• Refine: Special protocol studies instead of standard guidelineprotocols (e.g., shorter duration, fewer animals, single gender, etc)

• Refine: Pharmacokinetic studies in lieu of toxicity study

• In FY’16, waivers were granted for 153 of 180 requests resulting insavings of about 44,000 animals and over $16 million in the cost ofconducting the studies.

• In FY’17, waivers were granted for 70 of 78 requests resulting insavings of about 41,000 animals and approximately $10.4 million inthe cost of conducting the studies.


Type of Study Waivers Granted Required Studies Requests

Inhalation 229 65 294 Neurotoxicity 303 24 327 Dermal 55 8 63 Developmental 42 7 49 DNT 17 2 19 Subchronic Dog 13 3 16 Reproductive 32 6 38 lmmunotoxicity 212 17 229 Chronic/ Carcinogenicity 26 2 28 Subchronic Rat 13 3 16 Total 942 137 1079

EPA OPP Waiver Evaluations December, 2011 to April, 2018


Potential elimination of - 2600 animals/yr./facility USDA ~ - United States Department of Agriculture

2018: Cryopreservation of Virulent Serogroups

Cryopreserved Serogroups

CVB has made available virulent serogroups L. canicolaJ L. pomona, L. grippotyphosa, and L. icterohaemorrhagiae such that the live animal is not needed to maintain strains

https ://www. a phis. u sd a. gov/ an i mal health/vet biologics/publica

tions/vb reagent catalog.pdf

Cryopreservation Protocol

CVB has created a protocol to be used by any company that wishes to cryopreserve strains on their own.

htt ps ://www. a phis. u sd a. gov/ a phi s/ ou rfocus/a n i ma I hea lth/veteri na

ry-biologics/biologics-regulationsand-guidance/ct vb pros bb

16

Dr. Carol Clarke, USDA


In 2013, USDA CVB Targeted a 30% Decrease in Hamster Usage

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2013 2014 2015 2016 2017

Dr. Carol Clarke, USDA 17

encouraging the use and adoption of new methods and … · 2020. 7. 6. · - lnteragency...

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