Session C3: Policy Aspects of Chemicals Testing Initiatives and Alternatives

Chairs: Philip Sayre (USA) and Michael Balls (UK)

C3: HPV in the USA
Phlip Sayre. sayre.phil@epamail.epa.gov.

C3: The U.S. High-Production Volume Program: An Animal Protection Perspective
TBA. Physicians Committee for Responsible Medicine, 5100 Wisconsin Ave., N.W. Suite 400, Washington, DC 20016, USA.

The Environmental Protection Agency's (EPA's) High Production Volume (HPV) Challenge encourages chemical companies to volunteer to conduct screening-level animal toxicity tests on 2,800 industrial chemicals. Pursuant to this program, companies have committed to provide available toxicity information and present proposals to test chemicals. The Physicians Committee for Responsible Medicine (PCRM) has reviewed all test plans to date for compliance with the original HPV Challenge framework, as well as animal welfare guidelines issued by the EPA in October 1999. This review found major and recurring flaws in the program's execution, as well as its fundamental design. Of the 24 test plans submitted, 18 (75 percent) violate fundamental terms of the program. Many participating companies have failed to conduct comprehensive analyses of available data and have instead proposed unnecessary and inhumane tests. Furthermore, the program's exclusion of human health and exposure data is leading to irrelevant experiments that will not protect human health or the environment. This report, originally completed in August 2001, will be updated to reflect the current situation.

C3: EU Chemicals Testing Initiative
Gerald Vollmer (Italy). gerald.vollmer@jrc.it.

C3: The New EU Chemicals Policy: Challenges and Chances for Free Test Methods
Ursula G. Sauer. Akademie fuer Tierschutz, 85579 Neubiberg, Germany. ursula.sauer@tierschutzakademie.de.

The EU Chemicals Policy has been acknowledged to be slow, cumbersome, and inefficient in protecting humans and the environment from unknown risks through chemicals. It is currently undergoing a complete revision. In order to minimize animal testing, the European Commission has proposed to request only data from in vitro tests for the registration of low production volume chemicals. The data requirements for higher production volume chemicals shall be tailor-made. From the point of view of animal welfare, concrete risk management strategies should be defined before deciding on data requirements. Tiered testing strategies are to be laid down, making use of non-animal test methods, and concrete waiving strategies are to be designed, so that the requested substance-tailored testing will actually take place. Non-animal safety testing strategies are scientifically feasible. However, for some endpoints, further research in alternative methods is required. The funding of alternative method research has to be formulated as a key action with a concrete budget in the Sixth European Research Framework Program. In order to ensure that these goals are met, the European animal welfare movement is making an active contribution to the democratic process of compiling a new legislation on chemicals.