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21st-Century Chemical Regulation: Ensuring Protective Chemical Regulations That Avoid Animal Testing

 

Chemical Testing Basics

Toxicity Testing | Toxic Substance Control Act Reform 

About the Toxic Substances Control Act

mouse in lab gloved hand

The Toxic Substances Control Act (TSCA) was signed into law in 1976 and has been the prevailing legislation governing industrial chemical production and distribution ever since. TSCA requires a company to notify the Environmental Protection Agency (EPA) when it plans to manufacture a chemical. The EPA then assesses the potential hazards this chemical might pose to humans or the environment. When TSCA was enacted, however, chemicals on the market did not have to undergo any new safety evaluation. Instead, companies only had to submit information they had on hand. Many of these chemicals are still on the market today.

Some believe that this “backlog” of chemicals—estimates of the number of chemicals involved range from 7,000 to as many as 80,000—should be tested in animals immediately to discover whether any pose hazards to humans or the environment, and that revising TSCA is the way to accomplishing this.

But many scientists point out that a chemical-by-chemical approach using animal tests would be costly, inefficient, and virtually impossible given the number of chemicals involved. The best way to evaluate this backlog of chemicals is to use the human-relevant, high-throughput testing methods and strategies recommended in the National Research Council’s Toxicity Testing in the 21st Century: A Vision and Strategy.

About the Safe Chemicals Act of 2011 (S. 847)

To have no information is risky, but to have the wrong information is dangerous.

On April 14, 2011, Sen. Frank Lautenberg introduced the Safe Chemicals Act of 2011 (SCA). The bill was similar to the Safe Chemicals Act of 2010 in that it would extensively amend the existing law and require producers of industrial chemicals to better assess the potential hazards of chemicals before they reach the market.

For several years, PCRM and its allies have been working to ensure that these bills contained provisions that would prevent the suffering of potentially millions of animals in chemical testing laboratories. Because of the limitations of animal-based toxicity testing, the proposed legislative goals will not be accomplished through reliance on current toxicity testing methods. We told Congress that these efforts must provide the logistical and financial support needed to implement the NRC Vision, and must put in place strong protections for animals in laboratories, to reduce testing while the vision is being implemented.

Well, they listened.

SCA contained a number of provisions designed to reduce the numbers of animals killed in chemical testing and direct the EPA to fund and develop nonanimal test methods, as recommended by the National Academy of Sciences.

The bill gave the EPA the authority and flexibility to modify testing requirements based on a chemicals characteristics or what might already be known about a chemical or groups of chemicals. It also required the EPA to update Congress on its progress in implementing nonanimal alternatives every two years.

While this is excellent news, these provisions are only a first step. Most importantly, the EPA must be given the authority to require nonanimal tests. Given the option between an animal test and a nonanimal test, a nonanimal test should always be conducted—it’s that simple. This requirement has transformed test method research and development in the European Union, and it can do the same here in the United States.

The bill established a board to advise the EPA on its plan to replace animal tests. However, only representatives from other government agencies are required as members. This board must have public representatives with experience in nonanimal methods development, implementation, and advocacy.

Finally, while the bill does require the EPA to fund research into nonanimal methods, they did not specifically appropriate funding from Congress for this purpose. This means that other projects could supersede this research. Congress must specifically appropriate dedicated funding for vital research, as recommended by the National Academy of Sciences in its 2007 report Toxicity Testing in the 21st Century: A Vision and a Strategy.



 

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