areas of expertise additional areas of expertise · areas of expertise additional areas of...
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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 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.
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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
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.
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PISC’S PROJECTS AND GOALS
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“ 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
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