The Center for Alternatives to Animal Testing is an academic center affiliated with the Division of Toxicological Sciences in the Department of Environmental Health Sciences of the Johns Hopkins University Bloomberg School of Public Health.

 

Johns Hopkins School of Public Health

Proceedings for CAAT 20th Anniversary Symposium

TestSmart

Sidney Green
Howard University

The first TestSmart program was introduced to the scientific community in early 1999. TestSmart was established in an effort to highlight and promote more efficient and humane methods to screen chemicals for toxicity. Thus far, CAAT has identified four areas of regulatory testing that could benefit from a TestSmart approach: the high production volume (HPV) chemical testing program, the endocrine disruptor testing program, pharmaceutical safety and efficacy testing, and testing for acute toxicity. In 1999, TestSmart-HPV began as a collaborative effort by CAAT, the Environmental Defense Fund, University of Pittsburgh and Carnegie-Mellon University

TestSmart-HPV focused on the Organization for Economic Cooperation and Development's Screening Information Data Set (SIDS), which includes acute, repeat-dose, developmental, reproductive and genetic toxicity tests. A review of currently available alternatives to the SIDS battery identified several methods that could reduce animal use significantly. Recommendations included:

  1. Use OECD protocols that call for fewer animals for acute toxicity testing;
  2. Use two in vitro assays for mutagenicity in lieu of an in vitro test for gene mutation and an in vivo test for chromosomal effects, and
  3. Combine repeat-dose, developmental and reproductive studies into one protocol.

The EPA concurred with these recommendations and reduced its estimate of necessary animal tests by 80%.

TestSmart-Endocrine Disruptors intends to determine whether the testing planned by the EPA can be done more efficiently and humanely. Earlier this year, representatives of the EPA, industry, academia, and the animal welfare community sought to identify mechanisms for replacing and/or reducing animals or refining some of the proposed tests, as well as to set an agenda for a future public meeting. Discussion focused on the large number of animals required by the current testing plan, relevance of data to health effects and pain/distress issues. Potential alternatives were identified, including QSAR, HTP, in vitro assays and non-invasive imaging. Attendees reached several conclusions:

  1. Hormonally active chemicals exist in the environment that could cause adverse health effects;
  2. The approved testing program is flexible enough to permit a more efficient and humane approach to testing, and
  3. A larger, public meeting should be organized for March 2002 to gain wider input.

TestSmart-Pharmaceuticals reviewed the current state of pharmaceutical safety and efficacy testing and examine how new technologies might lead to more efficient and humane use of animals. In May 2001, stakeholders met for two days to consider the pharmaceutical development process, risk assessment, impact of new technologies, the regulatory environment, and new approaches to testing. Breakout groups were then convened in five areas:

  1. novel technologies and approaches,
  2. ways to implement the 3Rs,
  3. genomics, proteomics, bioinformatics,
  4. transgenic animals and
  5. the application of human cells in drug evaluation.

Conclusions and recommendations from the meeting address the need for more research, validation studies, and information/data sharing, as well as new approaches. Proceedings from the meeting-as well as detailed reports about each of the TestSmart programs-are available on the CAAT web site (http://caat.jhsph.edu) or on Altweb (http://altweb.jhsph.edu).

What is TestSmart?

Efforts of TestSmart to Date

High Production Volume (HPV)

High Production Volume (HPV)

The TestSmart Plan - Accomplishments

Endocrine Disrupters

The TestSmart Plan

Endocrine Disrupters

Discussion of large numbers of animals required, relevance of data to adverse health effects, difficulties in implementing in some industrial laboratories, strain/gender differences and pain/distress.

Endocrine Disrupters

Discussion of Potential Alternatives

Endocrine Disrupters

Areas of Agreement

Pharmaceuticals

AIM: to review the current state of pharmaceutical safety testing and examine how new technologies may lead to more efficient and humane use of animals

Pharmaceuticals

Organization of Meeting