Tuesday, May 4, 2010

New Safe Chemicals Act Mandates Reduced Animal Testing

The new Safe Chemicals Act of 2010 (SCA), introduced recently by Senator Frank Lautenberg with a companion bill in the House, includes several concepts that are not currently part of the Toxic Substances Chemical Act (TSCA) that it seeks to reform. One of those differences is the inclusion of a mandate to reduce animal testing.

Section 31 of the SCA states that EPA "shall take action to minimize the use of animals in testing of chemical substances and mixtures." This includes:

1) Encouraging and facilitating a) use of existing data of sufficient scientific quality, b) use of test methods that eliminate or reduce the use of animals but provide data of high scientific quality, c) grouping of two or more chemicals into scientifically appropriate categories where data on one substance will provide reliable and useful data on others, d) formation of industry consortia to jointly conduct testing to avoid unnecessary duplication, and e) parallel submission of testing from animal based studies and from emerging methods and models.

Those familiar with REACH might recognize a similar approach. The idea is to provide scientifically defensible data in the most efficient manner, so that modeling, read-across, alternative testing, and other methods can be used to meet the data requirements. The bottom line means less animal testing. The consortium idea also comes from the HPV Challenge days.

In addition, the section also authorizes:

2) the funding of research and validation of studies to reduce, refine, and replace (i.e., the "3 Rs") the use of animal tests.

The section also goes into some detail about an "Interagency Science Advisory Board on Alternative Testing Methods" that EPA shall establish within 90 days after enactment. The Board would consist of representatives from several key programs such as the NIEHS, CDC, NTP, NCI, NTSC and others. [Sorry for the acronyms, but I can define them if anyone doesn't already know what they mean.] The EPA, with input from the Board, would have one year to publish a list of testing methods that reduce the use of animals in testing. EPA and the Board would also promote the development of new testing methods that are not animal based. Finally, the section gives EPA some flexibility to waive testing requirements if there is sufficient weight-of-evidence from other sources.

So all in all there is an effort to reduce animal testing. That said, it is highly likely that animal testing will remain a key tool in the evaluation of hazard and risk. At least until sufficient non-animal methods have been developed and validated, a process that will likely take a long, long time.


kptnkate said...

This bill does include several ground-breaking measures to reduce reliance on animal testing - many of which were provided to the drafters by the animal protection community, and this is quite a leap forward for US regulation. However, there are a couple of points that need to be stronger: it falls short in requiring the use of alternative measures, as the European Council Directive 86/609 does this actually has an added benefit of spurring innovation in non-animal testing. The membership of the advisory board needs to be improved by requiring members to have expertise in non-animal test method development. The inclusion of a requirement to fund alternative methods development is also a new and forward-thinking precedent. The EPA is already headed in the direction of decreasing reliance on animal testing, and funding allocated in this bill will add momentum. Replacing animals in testing may not be so far off – some scientists and members of EPA itself have speculated it may be accomplished in as few as ten years.

Dake said...

Thanks for the additional information. I know there is much work being done in this area. The question is when will it be "accepted" enough to replace reliance on animal testing?