The Toxic Substances Control Act reform legislation signed into law June 22 makes significant changes to the United States rules on registration and risk evaluation of substances, creating a new regulatory landscape for the lubricants industry and others that work with large numbers of chemicals.
The first major re-write of the 40-year-old law also carries a number of specific impacts for the lubes industry. It does not prevent the Environmental Protection Agencys from continuing on a course to ban some categories of chlorinated paraffins; makes it easier for EPA to initiate evaluations of chemicals used in metalworking fluids; and establishes a new process for the introduction of new substances, such as those used as lubricant additives.
The final version of the law keeps language making it easy for EPA to classify some substances as new, thereby exposing them to safety assessment requirements not faced by chemicals that industry was actively using, in some cases for decades.
Being flagged as new under Section 5 of the law was a key step in EPAs attempt to ban use of medium- and long-chain chlorinated paraffins, chemicals that have long been popular for their effectiveness as extreme pressure agents in difficult metalworking fluid applications such as drawing, forming and metal removal.
The Independent Lubricant Manufacturers Association noted in a white paper analysis that an earlier Senate version of the TSCA reform had stronger language that likely would have kept MCCPs and LCCPs from being classified as new.
ILMA has pushed for EPA to classify MCCPs and LCCPs as existing substances under TSCAs Section 6, given the chemicals long history of use. The compromise bill that was enacted into law does not terminate EPAs process that its going through right now, ILMAs legal counsel Jeffrey Leiter – of Bassman, Mitchell, Alfano & Leiter Chtd. – told Lube Report. The new law does make it easier for EPA to regulate existing chemicals under Section 6, compared to the old statute. So on the one hand, EPA could use those risk assessments, check the box and move these over to the existing chemical process for the medium- and long-chain chlorinated paraffins. At the same time, nothing in the new law prevents EPA from continuing with their Section 5 reviews.
Leiter said likely the most immediate impact from the new law will be the requirement for EPA to publish its inventory reset rule by June 2017. In its white paper analysis of the law, ILMA noted that chemicals in commerce in 1976 when TSCA was originally enacted were presumed safe and placed on the TSCA Inventory list. A substance must be on the inventory for a chemical company to manufacture or import that substance. Under the amended law, EPA determines which chemicals are still in active commerce.
Theyre looking at bifurcating between substances that are active in commerce and those that are no longer being used, Leiter said. EPA still has the ability to look up and say that a particular product was never on the inventory, and therefore it has got to go through the Section 5 process as a new chemical.
We think folks up and down the supply chains are going to be looking at components and their mixtures, he added. If theres something high on EPAs list as a priority chemical, then customers are going to try to move to formulate away from those products.
The new law also has some ramifications for metalworking fluids formulations in general and for engine oil additives. Changes in the law make it easier for EPA to review metalworking fluid formulations, whether by testing or by other actions, he said.
On the engine oil side, he noted, the big issue is with approval of new additives under Section 5 through a process that requires companies to give EPA notice before they begin manufacturing. EPA has made [approval] easier, but at the same time, in the absence of data, is requiring people to come up with test information through a significant new use rule, also known as SNUR, he said.
ILMAs analysis distilled the new laws changes to six key ones:
- TSCA Inventory Reset: Within the first year after enactment, EPA must develop a rule for resetting the TSCA inventory. The intent is for EPA, using industry-supplied data, to maintain a real-time inventory of all chemicals in active commerce in the United States.
- Screening and Prioritization Process: All chemicals on the updated, active TSCA inventory will undergo a risk prioritization process, and EPA will designate chemicals a high priority or low priority.
- Risk Evaluation and Risk Management: High priority chemicals will be subject to risk evaluations. EPA will establish the scope of uses and exposures to consider, and the agency can order testing or the generation of new information. Based on the risk evaluation, EPA can ban a chemical or implement other risk management measures, such as restrictions or specific labeling. EPA can also perform risk evaluations on chemicals nominated by manufacturers.
- Order Authority: EPA can now compel testing or submission of information on a chemical through an order or consent agreement, rather than by a rule, under a legal standard that was significantly lowered.
- Confidential business information (CBI) claims for information submitted to EPA will have to be asserted and substantiated up front, as well as reasserted and re-substantiated on a periodic basis. This means that any CBI claims to protect the specific identities of existing, active chemicals on the list from disclosure would need to be reaffirmed and substantiated. The EPA must maintain both a confidential and non-confidential portion of the TSCA Inventory.
- Preemption of new state and local laws/regulations: State and local laws that were in effect as of Aug. 31, 2003, or actions taken or started on a specific chemical before April 22, 2016, will not be preempted by subsequent actions by EPA; however, other laws and regulations will be preempted under certain circumstances.
EPA must perform the following tasks by these deadlines under the new law:
- December 2016 – Undertake risk evaluations on 10 chemical substances drawn from the 2014 TSCA Work Plan
- June 2017 – Publish its inventory reset rule.
- June 2017 – Establish its risk-based screening process for high- and low-priority chemicals
- June 2017 – EPA must develop guidance for manufacturers to conduct and submit risk evaluations.
- June 2017 – EPA must establish a Science Advisory Committee on chemicals
- June 2018 – EPA must develop its policies and procedures for implementation of the law
- December 2018 – EPA must decide whether to revise its standards for small businesses
President Barack Obama signed the TSCA reform bill into law on June 22. Titled the Frank R. Lautenberg Chemical Safety for the 21st Century Act, bill H.R. 2576 passed in the House of Representatives by a 403-12 vote on May 24. The U.S. Senate voted unanimously earlier this month to forward it to President Barack Obama for him to sign it into law.
TSCA is the primary law governing chemicals in the U.S. market, including components of many lubricants. Enforced by the Environmental Protection Agency, the law has remained unchanged since its passing in 1976. The TSCA reform legislation details may be viewed at congress.gov here.