SOCMA Comments on Early Implementation Efforts
After the groundbreaking passage of the Toxic Substances Control Act (TSCA) reform bill, the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 22, 2016, much of SOCMA’s advocacy focus shifted to the regulatory side of things, making recommendations we believe will help ensure successful implementation of the “new” TSCA. While SOCMA supported passage of the bipartisan legislation, there have been notable challenges with implementation early on.
The new chemicals program has, unfortunately, been hamstrung. Many new chemical submitters are experiencing delays and pending regulation. A huge backlog of reviews persists. SOCMA rejects the idea that Congress, in its amendments to Section 5, somehow intended to reverse or flip the default, or null hypothesis, from “not unreasonably risky unless EPA can show otherwise” to “unreasonably risky unless the submitter can show otherwise.” Section 5 does not express a default presumption one way or the other. The biggest change to Section 5 is the affirmative finding of safety EPA has to make. As a practical matter, EPA has taken an extremely precautionary approach, more so than we believe is appropriate. SOCMA has made a public statement and submitted written comments on the new chemicals program critiquing the level of conservatism in their decision making. SOCMA is exploring ways to get the program back to its previous levels of productivity. We have co-sponsored a free pre-manufacturer notice (PMN) workshop/webcast to help members navigate the process and open a dialogue. Members should also consider contacting SOCMA’s PMNPro for assistance with their new chemical submissions.
Meanwhile, there are a number of proposed framework rules chemical manufacturers should pay close attention to, with more coming down the pike. Rules have already been proposed on the TSCA inventory notification process (inventory “reset”), the process for prioritizing existing chemicals for risk-evaluation and the process for risk-evaluation
SOCMA has submitted comments on the inventory reset, which would create a process to determine what chemicals on the TSCA inventory are “active” or “inactive” in U.S. commerce. Recommendations were made to establish a simple, straightforward process that would enable EPA to accomplish its mandate of simply determining what chemicals have been manufactured (including imported) at least once for non-exempt commercial purposes over the 10-year time period looking back from June 22, 2016. Some important points SOCMA highlighted include “one and done” reporting. In other words, if someone reports a chemical, no one else should have to. We also recommend that EPA allow
submitters to enter CAS numbers instead of chemical name and/or structure to make a chemical active. Requiring chemical names or structures would add enormous complexity. Date range reporting is another EPA proposal that is unnecessary. We recommend a submitter simply enter a date. Date ranges would add nothing, but unnecessary
burden, particularly to SOCMA members, many of which make many substances on demand. This process need not be overly complex. We are hopeful EPA will “keep it simple.”
SOCMA continues to work on prioritization and risk-evaluation proposals and is hopeful a well-structured, transparent process emerges putting into consideration “reasonably foreseeable” conditions of use versus all uses imaginable. Unfortunately, EPA seems to be taking a very broad-based approach when it comes to identifying use scenarios. SOCMA will have more to report on the rules and our comments. Members should stay tuned.
Members should pay attention to the greater authority EPA now has to evaluate confidential business information (CBI). SOCMA has long advocated for strong trade secret protections, given the importance of it to specialty chemical manufacturers. A process to substantiate CBI claims is in the works so members should be on top of this. EPA is now mandated to review all chemical identity CBI. Fortunately, there is no permanent sunset of CBI as long as the claim can be substantiated. A proposed rule on fee structure is coming down the pike and should emerge within the next month or two. SOCMA members should pay close attention to this rule as well.
Overall, the specialty chemical industry is once again well-positioned to share unique perspectives on EPA’s implementation of the new TSCA. Members of Congress and political appointees should take interest in how TSCA is impacting your businesses and will want to hear your stories. Stay tuned for opportunities to engage.
For more information please contact Dan Newton at firstname.lastname@example.org
, or (571) 348-5122