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AREAS OF EXPERTISE ADDITIONAL AREAS OF EXPERTISE US Environmental Protection Agency (EPA) and US National Toxicology Program Testing A PISC member achieved significant reductions in duplicative testing for the EPA’s high production volume chemical-testing programme, helping to establish the preferential use of non- animal methods for other government testing programmes. 1 Endocrine Disruptor Screening Program (EDSP) A PISC member published a tiered-testing strategy designed to significantly reduce animal testing in endocrine disruptor screening that has been largely adopted by the EPA in its EDSP21 Work Plan. In response to the PISC member’s submissions, the EPA has also accepted existing data in lieu of requiring new in vivo tests for some chemicals in the EDSP. 2 Vaccine Potency Testing A PISC member petitioned the US Department of Agriculture for acceptance of validated in vitro methods in place of challenge assays and prompted the agency to accept data from humane methods while deleting protocols for obsolete animal assays. PISC works on this issue internationally and disseminates information on approved non-animal techniques to vaccine manufacturers. Nanotechnology PISC scientists work with international regulatory bodies and participate in expert panels to develop and standardise in vitro nanotechnology testing strategies and implement these non- animal approaches. Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation PISC members convinced the European Chemicals Agency (ECHA) to issue guidance reducing duplicative testing under REACH and detailing ways in which chemical manufacturers can avoid animal-based tests. PISC members continue to work with companies and file ECHA appeals to ensure in vivo tests are avoided wherever possible. Shellfish Toxin Testing A PISC member funded the licensing needed to implement a more humane method to test for toxins in shellfish consumed by humans. This method replaces the use of a lethal challenge test using mice. Target Animal Batch Safety Testing (TABST) Following recommendations from PISC members, the UK Home Office eliminated barriers to ending TABST. PISC members obtained the deletion of TABST from all veterinary monographs in the European Pharmacopoeia. Dermal Corrosion Testing Following a PISC member’s rule-making petition to allow and promote available in vitro corrosion testing options without the need for additional permits, the US Department of Transportation replaced outdated information on rabbit use with new humane guidance. PISC ensures that information regarding the use of non-animal tests is accessible to all audiences. In addition, PISC members publish technical briefs and articles in peer-reviewed journals and routinely develop presentations for scientific conferences and workshops. Media content relating to these activities is often published in national and trade media. These documents and presentations are available at PISCLTD.org.uk/scipubs. PETA International Science Consortium, Ltd. Society Building, 8 All Saints Street London N1 9RL United Kingdom +44 (0) 207 837 6327 [email protected] PETA International Science Consortium, Ltd. (PISC), is registered in England and Wales as company number 08312511. PUBLIC AWARENESS CONTACT US Cover image: © iStock.com/luchschen 1 P Bishop, J Manuppello, C Willett and J Sandler, “Animal Use and Lessons Learned in the U.S. High Production Volume Chemicals Challenge Program”, Environmental Health Perspectives 120.12 (2012): 1631–39. 2 C Willett, P Bishop and K Sullivan, “Application of an Integrated Testing Strategy to the U.S. EPA Endocrine Disruptor Screening Program”, Toxicological Sciences 123.1 (2011): 15–25. PETA International Science Consortium, Ltd. (PISC), promotes and funds non-animal research methods and coordinates the scientific and regulatory expertise of its members: PETA UK PETA US PETA Netherlands PETA India PETA Germany PETA France PETA Australia PETA Asia
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AREAS OF EXPERTISE ADDITIONAL AREAS OF EXPERTISE · AREAS OF EXPERTISE ADDITIONAL AREAS OF EXPERTISE US Environmental Protection Agency (EPA) and US National Toxicology Program Testing

Sep 21, 2020

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Page 1: AREAS OF EXPERTISE ADDITIONAL AREAS OF EXPERTISE · AREAS OF EXPERTISE ADDITIONAL AREAS OF EXPERTISE US Environmental Protection Agency (EPA) and US National Toxicology Program Testing

AREAS OF EXPERTISE ADDITIONAL AREAS OF EXPERTISE

■ US Environmental Protection Agency (EPA) and US National

Toxicology Program Testing

A PISC member achieved signifi cant reductions in duplicative

testing for the EPA’s high production volume chemical-testing

programme, helping to establish the preferential use of non-

animal methods for other government testing programmes.1

■ Endocrine Disruptor Screening Program (EDSP)

A PISC member published a tiered-testing strategy designed

to signifi cantly reduce animal testing in endocrine disruptor

screening that has been largely adopted by the EPA in

its EDSP21 Work Plan. In response to the PISC member’s

submissions, the EPA has also accepted existing data in lieu

of requiring new in vivo tests for some chemicals in the EDSP.2

■ Vaccine Potency Testing

A PISC member petitioned the US Department of Agriculture

for acceptance of validated in vitro methods in place of

challenge assays and prompted the agency to accept data

from humane methods while deleting protocols for obsolete

animal assays. PISC works on this issue internationally and

disseminates information on approved non-animal techniques

to vaccine manufacturers.

■ Nanotechnology

PISC scientists work with international regulatory bodies and

participate in expert panels to develop and standardise in vitro

nanotechnology testing strategies and implement these non-

animal approaches.

■ Registration, Evaluation, Authorisation and Restriction of

Chemicals (REACH) Regulation

PISC members convinced the European Chemicals Agency

(ECHA) to issue guidance reducing duplicative testing under

REACH and detailing ways in which chemical manufacturers

can avoid animal-based tests. PISC members continue to

work with companies and fi le ECHA appeals to ensure in vivo

tests are avoided wherever possible.

■ Shellfi sh Toxin Testing

A PISC member funded the licensing needed to implement a

more humane method to test for toxins in shellfi sh consumed by

humans. This method replaces the use of a lethal challenge test

using mice.

■ Target Animal Batch Safety Testing (TABST)

Following recommendations from PISC members, the UK Home

Offi ce eliminated barriers to ending TABST. PISC members

obtained the deletion of TABST from all veterinary monographs

in the European Pharmacopoeia.

■ Dermal Corrosion Testing

Following a PISC member’s rule-making petition to allow

and promote available in vitro corrosion testing options

without the need for additional permits, the US Department of

Transportation replaced outdated information on rabbit use

with new humane guidance.

PISC ensures that information regarding the use of non-animal

tests is accessible to all audiences. In addition, PISC members

publish technical briefs and articles in peer-reviewed journals

and routinely develop presentations for scientifi c conferences

and workshops. Media content relating to these activities is often

published in national and trade media. These documents and

presentations are available at PISCLTD.org.uk/scipubs.

PETA International Science Consortium, Ltd.

Society Building, 8 All Saints Street

London N1 9RL United Kingdom

+44 (0) 207 837 6327 • [email protected]

PETA International Science Consortium, Ltd. (PISC), is registered in England and Wales as company number 08312511.

PUBLIC AWARENESS

CONTACT US

Cove

r im

age:

© iS

tock

.com

/luch

sche

n

1P Bishop, J Manuppello, C Willett and J Sandler, “Animal Use and Lessons Learned in the U.S.

High Production Volume Chemicals Challenge Program”, Environmental Health Perspectives

120.12 (2012): 1631–39. 2C Willett, P Bishop and K Sullivan, “Application of an Integrated Testing Strategy to the U.S.

EPA Endocrine Disruptor Screening Program”, Toxicological Sciences 123.1 (2011): 15–25.

PETA International Science Consortium, Ltd. (PISC), promotes

and funds non-animal research methods and coordinates

the scientifi c and regulatory expertise of its members:

PETA UKPETA US

PETA Nether landsPETA India

PETA GermanyPETA France

PETA Austral iaPETA Asia

Page 2: AREAS OF EXPERTISE ADDITIONAL AREAS OF EXPERTISE · AREAS OF EXPERTISE ADDITIONAL AREAS OF EXPERTISE US Environmental Protection Agency (EPA) and US National Toxicology Program Testing

Guiding Humane Innovation Towards Validation, Regulatory Acceptance and ImplementationThere is no guarantee that the successful development and

validation of non-animal techniques or the use of existing data

to satisfy regulatory requirements will be used in place of animal

experimentation. To ensure the replacement of animal testing in

animal-based testing requirements, PISC bridges the gap between

regulatory and research agencies to establish and promote clear

paths to validation and regulatory use of non-animal techniques.

Advancing Humane Methods Through Harmonisation Activities Regulatory acceptance of non-animal techniques in one region

or country is an open door to international harmonisation and

the wider statutory elimination of animal methods.

PISC participates in the agendas of the following international

organisations, among others:

■ Organisation for Economic Cooperation and Development

■ European Chemicals Agency

■ European Reference Laboratory for Alternatives to

Animal Testing

■ International Conference on Harmonisation of Technical

Requirements for Registration of Pharmaceuticals for

Human Use

■ International Conference on Harmonisation of Technical

Requirements for Registration of Pharmaceuticals for

Veterinary Medicinal Products

■ European Food Safety Authority

■ Brings scientifi c and technical expertise and extensive

knowledge of the international regulatory environment to

the development of regulated testing protocols.

■ Develops technical analyses, workshops, and scientifi c and

policy recommendations to coordinate efforts among regulatory

agencies, industry and standards-making organisations.

■ Collaborates with organisations including Fortune 100

companies in the chemical, medical device and pharmaceutical

fi elds and with non-animal test-method developers to ensure

available alternatives are used.

Funding Research and Validation Studies for Promising Non-Animal Tests

In cases where promising in vitro techniques require additional

development or validation to gain regulatory acceptance, PISC and

its members assist in providing funding. To date, PISC members

have contributed more than $1.5 million (€1.1 million) towards

improving and implementing non-animal research methods.

Projects funded in part by PISC members include the advancement

of QSAR models to estimate chemical carcinogenicity and toxicity,

including the OECD QSAR Toolbox, and other non-animal models to

test chemicals for acute toxicity, skin sensitisation and irritation,

and endocrine activity.

Imag

e: II

VS

PISC’S PROJECTS AND GOALS

© iS

tock

.com

/ver

seve

nd

“ PETA has been at the technical forefront of the

animal protection community in its campaign to

replace animal methods with in vitro methods in

regulatory toxicity testing. Importantly, they have

backed up their activities with real dollars to

support the development of non-animal methods.”

Rodger Curren, PhD, PresidentInstitute for In Vitro Sciences

Imag

e: II

VS