Regulatory paradigms such as EU REACH can require an immense amount of toxicology data much of which requires some form of animal testing. In practice the amended TSCA requires more data than the historical norm, but the Act also includes a mandate to develop alternative test methods (aka new approach methodologies or NAMs) thereby reducing the need for vertebrate animal testing. The USEPA recently published a draft plan that proposes a tiered approach:
The Agency has used NAMs to evaluate new chemicals, but in a limited way. The near term goal is to begin to incorporate the data generated by these methods in quantitative risk evaluation. The Act requires the USEPA to finalize a strategy by 22 June 2018.
EPA first outlined its goals and objectives for this strategic plan at a public meeting in November 2017. As you might expect there was an energetic response from both industry trade associations and NGOs regarding potential difficulties with this approach. Nevertheless, as a statutory requirement the Agency must proceed.
How Could It Impact Me?
The proposal may affect data requirements in the future if you submit Premanufacture Notices and/or a substance you manufacture/import/process/use is included in the systematic risk assessment of existing chemicals. The draft strategy is available and open for public comments. It will be discussed at a public meeting in Washington DC on 10 April 2018.
Ultimately the development of robust and defensible alternatives to animal testing that can be expensive (and in some cases, of questionable relevance to humans) could result in a step change in our understanding of the toxicology of chemicals. It also presents an opportunity for industry and the Agency to partner in methodology development and testing. It is important to maintain awareness of this process, especially if the being developed NAMs could apply to test endpoints relevant to your chemistry/technology.
knoell USA, LLC will continue to follow the amended TSCA regulation and can help you determine your company’s vulnerabilities and opportunities. We can also provide your company with periodic TSCA updates and assist you in positioning your company to address future regulatory requirements.
knoell USA can provide representatives of your company with a free consultation to talk you through the major changes enacted by the new law and how these changes could affect your business.
References and Related Documents