The original Toxic Substances Control Act (TSCA) was signed into law in 1976 with the purpose of regulating the manufacture, distribution, and sale of chemicals. The first substantive reform to TSCA occurred forty years later when the
Frank Lautenberg Chemical Safety for the 21st Century Act (LCSA) was signed into law on June 22, 2016.
The LCSA requires the United States Environmental Protection Agency (EPA) to conduct
formal reviews of new and existing chemical substances in commerce and determine whether a substance presents an unreasonable risk of injury to health or the environment under the conditions of use.
The primary changes in the chemical review process from “old TSCA” to the LCSA include:
- A more formalized process that now includes chemical assessments that are risk-based, and prohibits the consideration of cost, or other non-risk factors;
- The requirement for EPA to contemplate the “reasonably foreseen conditions of use” for a substance, in addition to evaluating the current and future uses;
- Replacing risk modeling techniques with requirements that chemical manufacturers provide hard data (or reliable analog data) to be used by EPA to evaluate chemical risk; and
- The requirement for a formal risk assessment if EPA decides insufficient data exists on a new or existing chemical.
Evaluating Chemical Risk
So how does the LCSA practically impact the EPA’s evaluation of chemical risk? Here’s a quick overview of how the new process is playing out:
- Organization: LCSA required the EPA to establish a Chemical Inventory reset, which lists “Active” chemicals that have been manufactured in the United States or imported.
- Prioritization: EPA then established a risk-based screening process for prioritizing chemicals. This determines which chemicals receive prioritization, identifying them as either a high-priority or low-priority substance. The priority list ensures that the most significant chemicals (based on hazards, use, and exposure risk) take precedence.
- Risk Evaluations: A high-priority designation for a substance triggers the risk evaluation process. The risk evaluation must be completed within three and a half years, and use best available science. The initial ten high-priority evaluations were conducted for the following substances: 1,4 Dioxane; 1-Bromopropane; Asbestos; Carbon Tetrachloride; HBCD; Methylene Chloride; N-Methyl pyrolidone; Pigment Violet 29; Trichloroethylene; and Tetrachloroethylene.
- Risk Management: Based on the required risk-based safety reviews of new chemicals, EPA must prohibit or restrict the manufacture, use, distribution, or disposal of any new substance if the chemical will not likely meet the safety standard. EPA can request additional information, if necessary, to make a safety determination.
LCSA Fees & Implementation
The EPA is required to adjust TSCA user fees to cover 25% of EPA’s cost to administer LCSA requirements under TSCA Sections 4, 5, 6 and 14. The new fee structure takes effect October 1, 2018. The proposed cost increase includes raising the Premanufacture Notice (PMN) review fee from $2,500 to $16,000, and charging $10,000 for reviewing test data under a test order, and $32,000 for review under a test rule.
Both industry and congress expect that a large increase in TSCA fees should result in significant improvement in EPA’s procedural efficiency and timeliness of review. The EPA faces a significant challenge to reduce the backlog of PMN and Significant New Use Notice (SNUN) applications in 2018. Although the EPA Office of Pollution Prevention & Toxics (OPPT) is working quickly to reduce the backlog of PMN and SNUN submittals, OPPT would like to require increased Pre-PMN collaboration between OPPT and chemical manufacturers. The OPPT is expected to release guidance on a Pre-PMN consultation process later this year.
The EPA will face significant challenges to meet current rule deadlines and will continue to be burdened by requirements to evaluate chemicals utilizing more demanding criteria. Additionally, there will likely be continued NGO challenges, and litigation associated with EPA’s chemical risk assessment process and priority structure.
Time to Take Action
To comply with new requirements under the LCSA, chemical manufacturers must continue to act:
- Assess all anticipated new chemicals. Consider filing an exemption, but if you must file a PMN or SNUN, make sure to provide as much health and environmental data as possible, including necessary analog data.
- Review all of your products carefully. Identify all substances manufactured, imported or processed from June 2006 to June 2016, confirm your products are on the TSCA Inventory, confirm duplicative substances that are being submitted by another manufacturer or group, and confirm that suppliers are going to submit notices for their products that you use.
- Focus on risk evaluations. Review the EPA scoping documents for the first ten high-priority chemical substances and determine how your products may be impacted.
- Engage EPA/OPPT. Communicate with OPPT directly to discuss your substances and the LCSA policy framework, and actively engage with industry associations and stakeholder groups to navigate the new rule.
With careful planning, and a solid organizational structure, most chemical manufacturers continue to effectively respond to the increase in regulatory activity and oversight under the LCSA, and Antea Group is committed to assisting our clients in meeting their regulatory obligations.
Still have questions? Contact us for expert support tailored to your specific organizational needs.
