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TestSmart--Endocrine Disruptors

February 21-22, 2001
Candler Building
111 Market Place, Suite 310
International Room
Baltimore, Maryland

Sponsors: 3M, Alberto-Culver Company, Bernice Barbour Foundation, Inc., Bristol-Myers Squibb Company, Exxon Mobil Corporation, The Gillette Company, Johnson & Johnson, Mary Kay Holding Corporation, Procter & Gamble Company, Rohm and Haas Company

Abstract for TestSmart -- Endocrine Disruptors

EPA's Testing Programs: Moving Towards Reduced Animal Use

Steve K. Galson

The mission of EPA is to protect human health and the environment. A number of EPA programs focus on this mission: the registration of pesticides, the Children's Health Program, and the High Production Volume Challenge. These programs encompass thousands of chemicals, many of which may not have been tested to ensure their safety. The first goal of testing is the identification and assessment of chemical hazards and risks. In the main, regulatory agencies have relied upon tests in animals to evaluate chemical safety. It is now recognized that strides can also be made to reduce animal usage and, in some cases, replace animals without sacrificing the ability to evaluate hazards and risk. There are opportunities to use test modifications in a number of different areas that are saving of animals, including acute toxicity, skin and eye irritation, skin contact allergy, and a combination of reproduction, developmental, and repeat dose toxicity. The Endocrine Disruptor Screening Program, which will be the topic of another presentation, is another example of how EPA is incorporating both good science and animal alternative considerations into test method development. The program will employ in vitro and in vivo test systems.

Office of Pollution Prevention and Toxic Substances: Testing Programs

Pesticides
Children's Health Program
High Production Volume Challenge Program
Endocrine Disruptor Screening Program

Voluntary HPV Challenge Program Principles

In general, animal experiments should not be performed if another validated method, not involving use of animals, is available
Review adequacy of existing data
Use SAR
Limits on Tests to be Used

1996 Food Quality Protection Act Mandates

EPA MUST:

Screen pesticides (both actives and others) for estrogenic effects that may affect human health
Develop a screening and testing program by August 1998
Implement the screening and testing program by August 1999
Report to Congress by August 2000

Endocrine Disruptor Screening Program Historical Overview -- Milestones

EDSTAC (August, 1996 to August, 1998)
71 recommendations (October, 1998)
Science Advisory Board and Scientific Advisory Panel (May, 1998)
Published proposed statement of policy and requested public comments (December, 1998)
EDSTAC report to Congress (Aug, 1999)
Peer review of EDSP by Science Advisory Board and Scientific Advisory Panel (April, 1999)
NRC Report, "Hormonally Active Agents in the Environment" (1999)
Report to Congress (August, 2000)
Extensive interagency and international relations established

Division of Responsibility Between EPA and ICCVAM

SAP Peer Review of EDSP
EDSP validation duplicative of ICCVAM
ICCVAM to review in vitro (ER and AR binding assays)

EPA Validation Process for the EDSP

Method Development
Pre-validation
Validation
Peer Review
Regulatory Acceptance

EDSP Validation Administration

EPA
- SAP and SAB
ICCVAM
OECD

ED Program Policy on Alternative Testing

Validation necessary for both in vitro and in vivo assays
Initial focus on EDSTAC recommended screens and tests
Refinement of protocols
Reduced animal suffering
Future replacement of animal tests when validated alternatives are available
Gene microassays for frog thyroid endpoints