The Reform of the US Toxic Substances Control Act and the Impact and Practical Application to the Personal Care & Cosmetics Industry was presented by Stacie Abraham and Nathan Potter, of UL Supply Chain and Sustainability, in August 2016.
This webinar provided a brief review of the former US Toxic Substances Control Act (TSCA), discussed the drivers and goals of reform, and delved into the significant changes. Most importantly, the presenters offered an analysis of regulatory obligations and their impact to the Personal Care & Cosmetics industry. What is the path forward, and and what challenges lay ahead? Let’s review.
The TSCA is the United States’ primary chemical control legislation, and applies to chemicals based on their intended use. Enacted in 1976, it has remained largely unchanged by its administrator, the Environmental Protection Agency (EPA).
As it exists today, the TSCA Inventory contains 80,000+ chemical substances that were presumed safe with no review, and no requirement for toxicity testing or exposure assessment. Of those chemicals on the Inventory, EPA has required testing for 400, and banned five.
TSCA reform is been in process and debated for many years, involving industry stakeholder input, the House of Representatives, and the Senate. President Obama signed the reformed bill into law in June 2016, effective immediately, with no transition period.
The reformed TSCA is now in effect as the Frank R. Lautenberg Chemical Safety for the 21st Century Act.
Select Significant Changes:
- There are new definitions of chemicals
- The Act explicitly specifies that EPA can mandate exposure testing; any actor in supply chain may be required to conduct testing or provide information
- The “Preemption” provision requires balance between State and Federal regulations
- The burden to prove the safety of a chemical now falls on Industry
- The Act includes reference to “potentially exposed or susceptible subpopulations”, who may be at greater risk to adverse health effects, such as infants, children, pregnant women, workers, or the elderly
- A manufacturer may request and pay for a Risk Evaluation (RE), and EPA must grant it
- To make affirmative findings, EPA will now require Industry to provide much more information on chemical hazards, exposures, and uses (both known and forseen), from all actors/points throughout the supply chain
- Both civil and criminal penalties have increased significantly, and are assessed per violation, per day
Key Points of Analysis
- The Lautenberg Act represents a fundamental change in the approach used by EPA in chemicals management, with far-reaching impact on multiples industries, and actors within those industries
- The reformed legislation is applicable to ingredients in personal care items that are considered consumer goods
- The requirement of an EPA affirmative finding will result in more regulation of new and existing chemicals
- EPA actions may impact both the availability to source specific chemicals and how they are allowed to be used, including those in the personal care and cosmetics industry
- If you are a chemical substance importer, you still must follow the same regulatory obligations as a manufacturer, as previously indicated in the former TSCA
The Challenging Path Ahead
With the upcoming election, there is some question about how the new administration will approach the new legislation. This could include EPA staffing, organization, and budget.
A few tips:
- Begin compliance preparation now.
- Review your product lines and assess the potential impact of the Lautenberg Act, throughout your supply chain.
- Monitor regulatory activity for any evaluations or assessments that may impact your product(s).
- If you are a manufacturer / importer of a high priority chemical, consider requesting and paying for an RE, if there are marketing considerations and benefits
UL can help!
UL The Wercs offers a variety of services related to compliance preparation:
- regulatory consulting and regulation activity monitoring
- risk assessments
- supply chain impact evaluation
- potential chemical risk evaluation and “safer” alternatives identification
Remember - this is just a high-level summary of some of the information presented in the one hour webinar. For additional details and comprehensive analysis of points impacting the personal care and cosmetic industry, please see the full webinar replay. The slide presentation is also available for download.
The views, opinions and technical analyses presented here are those of the author, and are not necessarily those of UL, ULProspector.com or Knowledge.ULProspector.com. While the editors of this site make every effort to verify the accuracy of its content, we assume no responsibility for errors made by the author, editorial staff or any other contributor. All content is subject to copyright and may not be reproduced without prior authorization from Prospector.