The Frank R. Lautenberg Chemical Safety for the 21st Century Act makes seismic changes in domestic industrial chemical management. If you think the extensive revisions to the Toxic Substances Control Act (TSCA) enacted on June 22, 2016, don’t impact your business, think again. TSCA reform affects virtually every domestic business sector involving chemicals and manufactured goods containing chemicals, and will continue to do so for years to come.
TSCA Reform: What Just Happened?
TSCA is the federal law that authorizes the U.S. Environmental Protection Agency (EPA) to regulate the import, manufacture, and processing of industrial chemical substances, defined to include just about every industrial chemical that goes into making a finished good. The new law greatly expands the EPA’s authority, and, if stakeholders and the EPA can get its implementation right, it will improve public health protection and restore much of the public’s confidence in chemical safety, a regrettable victim of the TSCA’s deficits. The law shifts the burden of the demonstrating chemical safety — all chemicals, old and new — to chemical manufacturers, processors and manufacturers of the finished goods that contain them, away from the EPA proving the opposite. A quick rundown of key provisions includes:
• Mandating safety reviews for chemicals in commerce;
• Eliminating the challenging “least burdensome” requirement for assessing chemicals in commerce, which for years prevented the EPA from taking meaningful action on these chemicals;
• Establishing a health-based safety standard, and authorizing the consideration of cost in developing risk abatement measures;
• Requiring the protection of vulnerable populations, including children and pregnant women;
• Limiting the ability of entities to claim information as confidential, thus, preventing disclosure, and authorizing sharing needed confidential information with states and first responders, as necessary, to fulfill their duties;
• Establishing judicially enforceable deadlines by which the EPA must act to implement the law;
• Preserving the role of states to regulate chemicals as balanced against the need for a clear and centralized federal chemical management law; and
• Requiring the EPA to prioritize its review of chemicals that are persistent and bioaccumulative, and that are known carcinogens and highly toxic.
What to Do First
To prepare for the new law’s implementation, which already has begun, interested stakeholders should do several things immediately.
First, read the law. While long and detailed, nothing beats reading the original text Congress penned: https://goo.gl/k2S0Bf. We prepared a detailed memorandum; our blog (TSCAblog.com) focuses exclusively on the new law to ensure its implementation is reported accurately and in a timely fashion, and to promote and facilitate broad public participation.
Second, know which chemicals are core to the business. The new law mandates that the EPA prioritize and evaluate “high-priority” chemicals according to an aggressive and judicially enforceable schedule. The EPA’s Work Plan for Chemical Assessments list of chemicals is a must-read for counsel. If this program is unfamiliar to you, it would be helpful for you to review the EPA’s TSCA Work Plan for Chemical Assessment website, https://goo.gl/rMrW27
Third, reassess confidential business information (CBI) claims and qualify new claims carefully. This process is not easy and will take time and resources to do well and comprehensively.
Fourth, expect more chemical testing. Even if your company isn’t actually conducting chemical testing or paying for it, your product line won’t be immune from the consequences of testing done on chemicals core to the business.
Fifth, focus on the upside and seize opportunities to develop new products to fill the inevitable chemical product deselection void. With change comes opportunity; new products with a distinctly sustainable profile will do well under the new law.
As TSCA has now been reformed, it’s time to think strategically and prepare to engage in the many initiatives that the new law requires, the collective result of which will fundamentally revolutionize chemical management in the U.S. Smart companies will see this as both a critically important business challenge and opportunity that requires stakeholders to be proactive and engaged.
LYNN L. BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at firstname.lastname@example.org
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006).