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Dakota Software's Blog for EHS and Sustainability Professionals

Will the Toxic Substance Control Act Finally Control Toxic Substances?

October 6th, 2017

Will the Toxic Substance Control Act Finally Control Toxic Substances?

Prior to 1976, any substance, from deadly asbestos to benign vinegar, flowed unregulated in the U.S. marketplace. With the passing of the Toxic Substance Control Act (TSCA) by Congress in 1976, one might think that the manufacture and sale of asbestos and other toxic substances in the market was adequately controlled, right? Wrong.

TSCA does not categorize substances as toxic or non-toxic. The three main objectives of the original 1976 law are:

  • Regulate substances that existed in the market prior to TSCA’s passing
  • Assess and regulate new commercial substances before they enter the market
  • Regulate the distribution and use of substances in the market.

In terms of regulating substances that existed in the market prior to TSCA (there were approximately 62,000), these existing substances were grandfathered in and considered safe unless EPA later found them to pose an “unreasonable risk to health or to the environment”. However, the “unreasonable risk” bar is high and costly to prove. And of all the grandfathered substances, only five have subsequently been banned (and asbestos is not one of them).

As for assessing new substances prior to marketplace entry, there are hurdles. EPA has only 90 days to make an “unreasonable risk” determination; toxicity data is often scarce; EPA can’t mandate that a company tests their substances unless a potential risk is already established.

And in regard to regulating the distribution and use of substances, this is accomplished by prohibiting the manufacture, import, and sale of substances that are not on the TSCA Inventory list (a list comprised of the aforementioned existing grandfathered substances and practically any new substance that isn’t glaringly virulent).

So what is the answer to TSCA’s inadequate control of toxic substances? The debate is almost as old as the Act. Some debaters align with the precautionary principle, that substances must be proven safe before being allowed in the marketplace. Others believe “safe” is a moving target and that cost-benefit analysis should dictate a substance’s place in the market. But most everyone has been ringing the bell for TSCA reform; enter the Frank R. Lautenberg Chemical Safety Act of 2016.

The Lautenberg Act amends TSCA with new provisions for existing substances, new substances, confidential business information, funding, and state authority. Following are highlights.

  • Existing substances: EPA must prioritize and then evaluate high priority substances with a new risk-based safety standard.
  • New substances: EPA must conduct a pre-market review and make an affirmative finding of a substance’s safety, or its new use, prior to allowing it into the marketplace.
  • Confidential business information: EPA must review new and past confidentiality claims, using new substantiation requirements as appropriate.
  • Funding: EPA is allowed to collect up to $25 million annually from chemical substance manufacturers and processors to offset costs of data review and risk evaluations.
  • State authority: States may continue to act on any substance or its particular use, but may be pre-empted by federal law in certain circumstances.

Will these 2016 amendments give TSCA its missing teeth? Many are hopeful. This past July, EPA finalized the processes it will use to prioritize and evaluate existing substances. And in August, EPA established procedures for designating substances on its Inventory list as either active or inactive to better focus its prioritization and evaluation efforts.

As with most things, time will be the telling factor in whether these new amendments finally let TSCA control toxic substances. And as EPA continues to implement these amendments, Dakota will continue to update our products to reflect every, and any, change.

Shannan Delaney

Shannan Delaney

Regulatory Analyst

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