REGULATORY ALERT: TSCA REFORM AND SUSCEPTIBLE SUBPOPULATIONS

10 October, 2016

What’s Happening?

With the implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, important changes are coming to the various provisions of TSCA.   These new requirements are resulting in changes not only in how the Agency will perform their work but also in how the regulated community will approach compliance.  

For example under new TSCA, the agency must identify “potentially exposed or susceptible subpopulations” in chemical assessments and must ensure their protection.  Potentially exposed or susceptible subpopulations are defined as “a group of individuals within the general population identified by the Administrator, who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers or the elderly”.

In the review of new chemicals or significant new uses, the Agency must make a determination that either the chemical substance or new use A) presents an unreasonable risk, B) the information provided is insufficient to permit a reasoned evaluation or C) is not likely to present an unreasonable risk.  The EPA must take susceptible subpopulations into consideration when doing the chemical assessment.  This is a change from the previous version of TSCA.

Additionally, the agency must designate chemical substances as either high-priority or low-priority.  Potential risk to susceptible subpopulations may result in a chemical substance being designated as high-priority thus requiring the EPA to conduct a risk evaluation.

How Could it Impact Me?

EPA’s assessment strategy must be adapted to include consideration of these vulnerable populations.  This may impact the current tools and models which the EPA is using to assist in the assessments.  This focus on susceptible subpopulations in the assessment process may also result in additional consent orders as the Agency may seek to limit manufacturing methods and uses which may pose unreasonable risk to these subpopulations.

Contact Us:

Critical Path Services can help you to navigate through the requirements implemented through TSCA Reform.  We have people on our team that are highly experienced with TSCA regulations and specifically, with the EPA’s New Chemicals Program.  

In addition, there are members of our Industrial Chemicals team that have experience in both running the Sustainable Futures models and in interpreting the output of the models. These models are important tools used by the EPA in their risk assessment processes.

Critical Path 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.

Business Units: 
Elizabeth Dederick, Ph.D. Vice President, Industrial Chemicals and Biocides
+1 610 558 3001 Ext. 102 +1 610 558 6025 send mail