After 40 years of serving as the regulatory roadmap for the manufacture, distribution, and sale of chemicals in the US, the Toxic Substances Control Act (TSCA) was reformed in 2016. Congress passed, in rare bi-partisan fashion, the Frank Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) and it was signed into law on June 22, 2016.
The Lautenberg Act requires the US 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.
So, what’s new for 2019 and beyond, and how does it impact your business?
2019 SNUR Update
On April 5, 2019 the EPA published significant new use rules (SNURs) for 13 chemical substances which were the subject of premanufacture notice (PMN) rule review. The EPA compiled certain “reasonably foreseen” conditions of use during their review that were identified as significant new uses in the final SNURs. The SNURs require chemical manufacturers to notify EPA 90 days before commencing with any activity designated as a significant new use by submitting a significant new use notice (SNUN.) The SNUN would be reviewed by the EPA, which would then issue a TSCA Section 5 finding.
When reviewing the PMNs for the 13 chemicals, EPA made “not likely” determinations for the intended uses identified in the PMNs. The April 5th rule serves as a new “vehicle” for EPA to issue SNURs for new or existing chemicals. After issuance of the SNUR, the clock doesn’t start until a manufacturer wants to produce that chemical using a SNU Notice. Timely review was a goal of the Lautenberg Act, and this multi-step process helps the agency focus resources to meet the industry-requested time limits for EPA reviews of PMNs and SNUNs.
This approach veers substantially from EPA’s long-standing practice of using a “SNUR-only” strategy. EPA issued a “framework” policy document in 2017 that was challenged in court. The lawsuit was subsequently withdrawn without court review, but the April 5 final rule revives EPA’s approach of issuing SNURs without enforcement orders. This will likely lead to a legal challenge, and the court’s review of the Agency’s authority to implement the SNUR-only approach for new chemical substances under TSCA.
2020 CDR Update
On April 12, 2019, the EPA Office of Chemical Safety and Pollution Prevention submitted a proposed rulemaking that addresses the upcoming 2020 Chemical Data Reporting event. Here are some the changes that we see having the greatest impact:
- Instead of new exemptions for small manufacturers to decipher for applicability, EPA is proposing the same two-pronged approach that was used in 2016--but with higher dollar thresholds based on US Small Business Administration consultation. The exemption thresholds for small manufacturers jump from $4 million to $11 million in overall sales, or from $40 million to $110 million when less than 100,000 pounds of the subject chemical is manufactured. With higher exemption thresholds, additional manufacturers (and importers) may become exempt from the 2020 reporting event, which helps those smaller entities.
- EPA is proposing that the existing classification scheme in CDR be aligned to the Organization for Economic Cooperation and Development’s (OECD) functional use and product/article use codes. This sensible change allows for direct comparison with EU and Canadian data collection, though it may require more effort from the manufacturer upfront, since they can’t rely as heavily on the previous report for guidance.
- EPA is proposing to change the requirement to indicate whether a chemical is removed from the waste stream and recycled, remanufactured, reprocessed, or reused with a requirement to indicate whether a chemical is removed from the waste stream and simply recycled--and requiring the percent total production volume of a chemical substance that is a byproduct. These changes will be difficult to calculate, and the regulated community should comment on the proposed rule to ask for changes to the approach.
- Most importantly to industry, EPA is proposing changes for making confidential business information (CBI) claims, including identifying when upfront substantiation is required, updating the substantiation questions, and identifying data elements that cannot be claimed as confidential to align with the Lautenberg Act. Manufacturers will need to closely evaluate their substantiation strategy for CBI claims with these changes to CDR questions in mind.
While EPA is proposing additional changes to CDR, these key points are poised to affect many manufacturers as they prepare for the 2020 CDR Event.
Upcoming TSCA Deadlines and Actions
- June 19, 2019: Deadline to submit comments and “relevant information” on EPA’s next 40 substances for TSCA prioritization (20 high-priority & 20 low-priority.)
- June 24, 2019: Deadline for comments on EPA’s proposed procedures for reviewing CBI claims for the identity of chemicals on the TSCA Inventory.
- July 1, 2019: Deadline for reporting under TSCA mercury rule.
- December 2019: Deadline for EPA to finalize risk evaluations for the “first ten” chemical substances (but possible 6-month extensions.)
- December 22, 2019: Deadline for EPA to finalize prioritization for next 40 substances (20 high-priority candidates & 20 low-priority) and for EPA to initiate risk evaluations on at least 20 high-priority substances.
Other Notable Dates
- Late 2019: EPA will determine whether a manufacturer request for a TSCA risk evaluation of two phthalates contains the minimum needed elements to proceed (and if so, will publish the request in the Federal Register for public comment.)
- Late 2019: Rulings likely in litigation over TSCA Prioritization and Risk Evaluation Rules.
- NRDC v. EPA (9th Circuit No. 17-73290)
- Oral argument scheduled for May-June 2019
- April 18, 2020: Deadline for Congress to reauthorize the Chemical Facility Anti-Terrorism Standards program (upon expiration of current 15-month reauthorization.)
- 15-month reauthorization of CFATS passed by congress and signed by the president in January 2019
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 Lautenberg Act, and Antea Group is committed to assisting our clients in meeting their regulatory obligations.
