TSCA New Chemicals Coalition will give the chemical community greater opportunity to engage with EPA on constructive, helpful, and informed improvements to the new chemicals review process.
Section 5 of the Toxic Substances Control Act (TSCA) addresses new chemical notifications and, as such, is chemical innovation’s regulatory gatekeeper. The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) amended Section 5. The U.S. Environmental Protection Agency’s (EPA) interpretation of these amendments has changed significantly the Section 5 review process in ways that none of us fully anticipated; the numbers speak for themselves. Under old TSCA, approximately 90 percent of new chemical notifications entered commerce without restriction. Since Lautenberg, this number is in the 20 percent range, a remarkable change given the absence of clear Congressional intent fundamentally to amend the new chemicals program.
WHY TSCA NEW CHEMICALS COALITION IS NEEDED
That EPA is now required to make a determination on all new chemicals (or significant new uses of existing chemicals) is at the heart of the changes in EPA’s review of new chemicals, and the new policies and practices that have emerged since June of 2016. What is less clear is how EPA is making these determinations. The “how” part is undoubtedly the sum of a complex calculus employing new terms and concepts. These terms and concepts include “conditions of use,” “reasonably foreseen,” “potentially exposed or susceptible subpopulation,” “unreasonable risk,” “extent necessary,” and “insufficient information.” This is further complicated by the working application of those terms and concepts by EPA risk evaluators and risk managers, along with a series of explicit and implicit assumptions, policies, and “PMN trade-craft” that are uniquely ill-suited for coherent summary and description to premanufacture notification (PMN) submitters.
All of this caught the chemical community off guard, as many of us thought the Section 5 process was generally working well, and believed Congress thought similarly. While we recognize not everyone shares this view, we believe that even those most receptive to the concept that the Section 5 program needed fundamental change would be hard pressed to rationalize the scope of the changes and some of the decisions coming out of the Section 5 process. The near absence of a line of sight on the process used to make these decisions is equally troubling. Here are a few examples:
Conflating hazard and risk: Under new TSCA, and based on our experience, EPA has been imposing regulations in all cases where EPA identifies a hazard. EPA’s argument is that it must protect against “reasonably foreseeable” conditions of use. If EPA identifies skin corrosivity, for example, as a hazard of use of an industrial intermediate chemical, EPA now seeks to impose a consent order and Significant New Use Rule (SNUR) requiring personal protective equipment (PPE), even if use of such PPE is a standard operating procedure to meet standards under the Occupational Safety and Health Act (OSH) Act.
EPA might wonder “what if” the worker does not use the required PPE. We question whether such “what if” scenarios meet the meaning of “reasonably foreseeable” or “to the extent necessary to protect against an unreasonable risk.”
Over-regulation of inhalation hazards: EPA’s approach to inhalation hazards has also caused significant disruptions to chemical manufacturers. EPA has identified four categories of inhalation hazards for which it had “insufficient information” to make a reasoned evaluation of the hazards: general surfactancy, cationic binding, water-proofing chemicals, and lung overload from poorly soluble particles. Based on our experience, EPA has imposed up-front testing on any substance that fits into one of these categories, essentially arguing that no amount of inhalation protection would be sufficient to protect against the “unknown” hazard associated with these classes of substances. Given that there are hundreds, if not thousands, of substances in commerce included in these categories, the notion that a new substance that is very similar to an existing substance cannot safely enter commerce absent up-front, sub-chronic inhalation testing is difficult to justify. EPA has refined the categories somewhat since its initial determinations, but EPA’s determinations remain exceedingly precautionary. EPA’s proposed exposure limit for new surfactants, for example, is 8 x 10-5 mg/m3. An exposure limit this low would seem to imply that a consumer hard surface cleaner is so hazardous as to require a full-face respirator to use safely. To put this in perspective, toluene diisocyanate (TDI), a highly hazardous polyurethane precursor that is believed to cause chronic lung damage, has an Integrated Risk Information System (IRIS) Reference Concentration of 7 x 10-5 mg/m3. Another way to think about this extremely precautionary level: it corresponds to the exposure that a consumer would experience from two pumps of a spray cleaner with ten percent surfactant.
Regulation of Exempt Polymers: Another example is EPA’s drastically different approach to regulating exempt polymers before and after Lautenberg. Long ago, EPA concluded that polymers that meet the polymer exemption criteria are inherently low hazard. Prior to Lautenberg, EPA would “drop” PMNs for polymers that met the exemption criteria. Under new TSCA, EPA seems to be of the view that EPA must limit how these polymers are made such that only a polymer meeting the exemption criteria can be produced. The argument goes that since a company could manufacture a polymer under a particular name in a way that does not meet the exemption criteria, such manufacture is “reasonably foreseeable” regardless of whether EPA could actually identify such. EPA has proposed numerous consent orders for otherwise-exempt polymers. Fortunately, EPA’s position on exempt polymers has evolved, partly in response to expressions of industry concern, and partly in recognition of the tremendous burden such a policy places on EPA. EPA now identifies new polymers that meet the polymer exemption criteria with a “polymer exemption flag.” The flag limits how the substance may be manufactured, but limits this to specific polymer exemption criteria rather than citing to all of the polymer exemption provisions that would provide the manufacturer with the same flexibility that is available under the exemption. This is an example of a creative solution that we believe provides a promising foundation on which to build a more workable New Chemicals Program.
The nature of the New Chemicals Program is that there is little, if any, line-of-sight on decisions on individual submissions. EPA makes its determinations based on the factual information set forth in a PMN and additional modeling and assumptions. Given the prevalence of Confidential Business Information (CBI) in new chemical submissions, there is no way, however, for submitters to determine whether EPA’s determinations are consistent. Similarly, it is difficult to discern common approaches to regulation that EPA might be pursuing among structurally similar substances.
We recognize and applaud EPA’s commitment to release later this year “draft documents that will provide the public with more certainty and clarity regarding how EPA makes new chemical determinations.” A key reason we believe a coalition needs to be organized now is to prepare meaningful comments and offer constructive, helpful, and informed improvements to the new chemicals review process. It will be nearly impossible to prepare comprehensive comments and address the many issues that we anticipate addressing once EPA distributes the draft documents, and solicits comment, presumably within a relatively short time period. Historically the Section 5 process has been one uniquely shrouded in secrecy; working around CBI is challenging. We believe, however, that these challenges are best addressed by a community of stakeholders, rather than individual ones. A coalition of submitters is far better situated to discuss critical issues and common themes without discussing specific details. These discussions will provide greater insight into EPA’s approaches and offer an opportunity to engage with EPA to find workable solutions that meet TSCA’s statutory obligations without causing avoidable commercial disruption or imposing unnecessary testing burdens.
EPA’s hard work in implementing Lautenberg is commendable, especially so given a change in Administration. Nothing stated or implied here is intended to impugn EPA’s efforts. Bergeson & Campbell, P.C. (B&C®) remains committed to ensuring TSCA’s implementation fulfills Congress’ goals. Institutionally, B&C has volunteered considerable time and effort over the past year in analyzing the law and EPA’s interpretation and application of it, and has worked hard to assist EPA and other stakeholders with the implementation process. See below for a summary of some of our contributions in this regard.
THE B&C TEAM
B&C professionals are uniquely qualified to organize and lead such a coalition. Our staff, unique in the depth and breadth of its TSCA experience, includes highly experienced TSCA experts, both former EPA officials and other experts, who have made a career in TSCA implementation, in areas including the chemical nomenclature and Inventory issues, risk assessment, risk management, and other TSCA-related issues. Our professionals include a number of high-level EPA alumni, including:
• Charles M. Auer, former Director of EPA’s Office of Pollution Prevention and Toxics (OPPT) and of the Chemical Control Division with direct responsibility for the new chemicals program; Mr. Auer was with OPPT for over 30 years and offers a wide portfolio of expertise including regulatory compliance requirements for new and existing chemicals, nanoscale materials, and intergeneric microorganisms;
• Oscar Hernandez, Ph.D., former Director of the Risk Assessment Division (RAD) in OPPT that handled EPA’s reviews of the hazards and risks of new chemicals; with over 30 years in OPPT plus a Ph.D. in organic chemistry, Dr. Hernandez offers expert scientific support and expertise pursuant to TSCA hazard and risk assessments (including Structure Activity Relationships (SAR) analysis) and other federal, state, and international chemical control authorities;
• Richard E. Engler, Ph.D., former Senior Staff Scientist in OPPT and leader of EPA’s Green Chemistry Program; Dr. Engler holds a Ph.D. in physical organic chemistry and has participated in thousands of TSCA substance reviews, as well as pre-notice and post-review meetings with submitters to resolve complex or difficult cases;
• James V. Aidala, former EPA Assistant Administrator for Toxics under the Clinton Administration; Mr. Aidala has been closely involved with TSCA legislative reauthorization and key regulatory matters for over two decades, and offers significant value in addressing chemical policy and related issues; and
• Timothy D. Backstrom, former Senior Counsel in EPA’s Office of General Counsel (OGC) who spent many years working on pesticide, toxic substances, and air quality issues there; Mr. Backstrom offers an extraordinary understanding of how EPA operates, as well as established relationships with many key players at EPA.
B&C hosts one of the largest legal practices focusing on TSCA and other chemical programs. Our attorneys include: Lynn L. Bergeson, Lisa M. Campbell, Lisa R. Burchi, Timothy D. Backstrom, and Bethami Auerbach. Other non-legal B&C professionals focusing on TSCA include Sheryl Lindros Dolan, Kathleen M. Roberts, Joseph E. Plamondon, Ph.D., R. David Peveler, Ph.D., Jane S. Vergnes, Ph.D., DABT®, Michael S. Wenk, M.S., and Heather F. Collins, M.S. We are confident our expertise and leadership would add considerable value to this initiative.
JOINING THE COALITION
Joining the coalition is easy. We are asking for a flat fee of $1,000 per company for a 12 month period. We are not allowing trade associations to join. The chemical community has participated in ad hoc coalitions for years, so the drill is familiar. Dues will be used to:
• Convene meetings and calls;
• Develop advocacy positions on crucial issues to be decided and prioritized, including preparing for EPA’s Fall 2017 release of documents on how it reviews new chemicals; and
• Provide informed and effective comment on these issues and meet with EPA leadership to advocate for the Coalition’s views on these issues.
FOR MORE INFORMATION
For further information, call or e-mail Lynn L. Bergeson at 202-557-3801 or [email protected]