2016 marks the year that major reform of the Toxic Substances Control Act (TSCA) is likely. Alston and Bird has been following and participating in the multiyear legislative process that will give the U.S. Environmental Protection Agency (EPA) new and unprecedented authority over our clients in chemical and product manufacturing, counseling companies and trade associations on the issues and their positions on them.
The TSCA and EPA’s implementing regulations set forth detailed requirements for the production, import and use of chemical substances and mixtures. Our attorneys assist clients with TSCA regulatory and litigation matters, including compliance assistance and enforcement defense.
We have assisted a number of clients in the chemical, petroleum, consumer product, manufacturing, pharmaceutical and other industries in virtually all aspects of the TSCA. We work closely with chemical manufacturers, producers, importers and exporters as well as key trade associations. We are active on many developing issues under the TSCA, including the EPA’s Chemical Data Reporting (CDR) Rule, significant new use rules (SNURs) and TSCA legislative reform.
We have defended clients in major TSCA enforcement actions, including negotiating with the EPA and Department of Justice, litigating civil penalty assessments before administrative law judges and defending TSCA injunctive actions filed by the government in federal court.
Through our Brussels office, we assist clients on the interface between the TSCA and the European Union’s REACH (EC Regulation 1907/2006 – the Registration, Evaluation, Authorisation and Restriction of Chemicals).
Our practice includes counseling and advocacy on state chemical management activities, including California’s Green Chemistry Initiative and Proposition 65; Washington, Vermont, Oregon, Maine and other state green chemistry laws; and state chemical-specific restrictions on products. We also help clients address the business impacts of today’s focus on potentially toxic materials. We monitor regulatory and interest group initiatives and assess their potential effects on our clients and their markets. We help clients communicate with stakeholders about their products and develop product stewardship programs that encourage appropriate lifecycle management, reducing the risks to their products and in their supply chain. If product restrictions are proposed, we represent our clients in commenting on agency rulemakings, negotiating acceptable risk reduction measures and, if necessary, challenging unreasonable restrictions in court.
Specifically, in our practice we help clients:
Comply with reporting requirements under the CDR Rule and other provisions of the TSCA, such as the “substantial risk” reporting requirements of Section 8(e).
Determine the status of substances or mixtures under the EPA’s TSCA Inventory, including the confidential portion of the Inventory.
Prepare the premanufacture notification (PMN) and respond to SNUR requirements so that the EPA reviews and approves new chemical substances and certain new uses, including eligibility for PMN or SNUR exemptions and other strategies to expedite approvals, minimize product restrictions or resolve the adequacy of existing Inventory listings.
Prepare required notifications and comply with the TSCA’s import and export rules.
Comply with the EPA’s regulations for managing PCBs.
Comply with chemical testing under TSCA Section 4 and voluntary programs such as those developed to generate data on high production volume (HPV) chemicals and children’s health.
Meet TSCA reporting and recordkeeping requirements, including the “substantial risk” notification requirements and the EPA’s Inventory Update Rule.
Navigate the conflicts and inconsistencies between the TSCA and statutes governing pesticides, foods, drugs and cosmetics.