On July 22, 2016, the U.S. Environmental Protection Agency (EPA) posted on its website the first four Section 5(a)(3) determinations for premanufacture notices (PMN) under the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. No. 114-182) (new TSCA). All four of the new chemicals were determined to satisfy the "not likely to present an unreasonable risk" determination at Section 5(a)(3)(C). It is notable that all four determinations relied on structure activity relationship (SAR) analyses and data on analogs.

In all four cases, EPA found low potential for health hazards and low potential for environmental hazards (low/low). EPA estimated that each substance has some degree of persistence (from limited persistence to very persistent) and that all four have a low potential for bioaccumulation. Based on our experience with the new chemicals program under TSCA prior to new TSCA, when EPA made a low/low hazard call and either a low potential for persistence or a low potential for bioaccumulation, EPA "dropped" the submissions from further review, avoiding the time and expense of performing exposure assessments on substances of low potential hazard.

Under new TSCA, to make a Section 5(a)(3)(C) determination, EPA must identify potentially exposed or susceptible subpopulations (PESS) that are relevant under conditions of use. In these four Section 5(a)(3)(C) determinations, EPA identified known or reasonably foreseeable uses in addition to the uses identified in the PMNs. EPA identified the PESS under the intended use as workers for all four cases. We note that EPA identified consumers as a PESS if the substance notified in P-15-0281 was to be used as a lubricant or lubricant additive (the known or reasonably foreseen use that EPA identified). Even considering the PESS, EPA has concluded that a low hazard finding is sufficient to support a "not likely to present" finding under Section 5(a)(3)(C) and did not perform a formal exposure assessment. Since EPA has published the Section 5(a)(3)(C) findings, per Section 5(g), the submitters of these four PMNs may commence manufacturing without waiting for the remaining portion of the 90-day review period to expire.

Commentary

EPA determined that all four new chemicals satisfy the "not likely to present an unreasonable risk" determination under Section 5(a)(3)(C). The conditions of use for these chemicals indicate industrial scenarios that would point to workers as the PESS. The potential exposure to workers was not estimated. Instead, the determination of not likely to present an unreasonable risk hinges on the low hazard potential for these chemicals. Three of the four chemicals were estimated to be persistent with two categorized as very persistent. The chemicals were estimated to have low potential for bioaccumulation. No information was provided about potential releases to water.

It is reassuring that the SAR was used to reach determinations about persistence, bioaccumulation, and hazard potential, including mention of category analysis. This suggests that EPA intends to maintain SAR as a basic component in its evaluation of new chemicals consistent with the provisions at Section 4(h) to reduce vertebrate animal testing and to maximize the use of existing hazard information.

By Lynn L. Bergeson

On Friday, July 22, 2016, the U.S. Environmental Protection Agency (EPA) posted the first four Toxic Substances Control Act (TSCA) Section 5(a) determinations made following review of pre-manufacture notifications (PMN) according to TSCA as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century law, Pub. L. No. 114-182 (Lautenberg).  EPA’s determination on all four chemical substances was “not likely to present and unreasonable risk,” under new TSCA Section 5(a)(C)(3).  The PMN Case Numbers, Chemical Identities, a summary of the determination, the decision dates, as well as the links to the determinations themselves are below.  The review start date for all of these determinations was the date of Lautenberg’s enactment, June 22, 2016.  Bergeson & Campbell, P.C. (B&C®) is reviewing these determinations and will provide an analysis.

• P-16-0281:  Generic: Fatty Alcohols-Dimers, Trimers, Polymers.  EPA determined that “[t]he chemical substance is not likely to present an unreasonable risk based on low health hazard concern and low environmental toxicity.”  The decision was issued on July 15, 2016.
• P-16-0292:  Generic: Depolymerized Waste Plastics.  EPA determined that “[t] he chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard.  Although EPA estimated that the new chemical substance would be very persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard.”  The decision was issued on July 20, 2016.
• P-16-0301: Generic:  Propyl Silsesquioxanes, Hydrogen-Terminated.  EPA determined that “[t]he chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard.”  The decision was issued on July 20, 2016.
• P-16-0302:  Generic:  Organic Modified Propyl Silsesquioxane.  EPA determined that “[t]he chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental toxicity. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard.”  The decision was issued on July 20, 2016.

On July 18, 2016, Bloomberg BNA’s Daily Environmental Report reported on the U.S. Environmental Protection Agency’s (EPA) new chemical notice process, and included insight from industry leaders at Bergeson & Campbell, P.C.’s (B&C®) July 14, 2016, webinar, The New TSCA: Impacts on New and Existing Chemicals Programs. 

B&C Managing Partner Lynn L. Bergeson was quoted as saying that premanufacture notifications, or PMNs, that chemical manufacturers must submit before they can produce or import a new chemical, and significant new use notifications, which companies must submit before they can make or use certain chemicals in new ways, “need to be much more strategic, thoughtful and detailed.”

Both the old and newly amended TSCA state the EPA's “authority over chemical substances and mixtures should be exercised in such a manner as to not impede unduly or create unnecessary economic barriers to technological innovation,” Bergeson stated, referring to Section 2601(b)(3).  The new law makes “very consequential changes” to the new chemicals provisions of TSCA as EPA will have to balance carefully the requirements imposed by different sections of the law.

Richard A. Denison, Ph.D., Senior Scientist with the Environmental Defense Fund, stated that the changes the amended law makes to EPA's new chemicals program “are not trivial.”  Further, the changes will make it easier for the public to understand why EPA concludes that new chemicals may or may not enter commerce, what restrictions it may impose on the uses of those chemicals, and why.

BNA’s article, “Detailed New Chemical Applications Needed to Boost Market Chances: Attorneys,” is available online, through paid subscription.

Bergeson & Campbell, P.C. (B&C^®) has learned that the U.S. Environmental Protection Agency (EPA) is planning to convene a stakeholder workshop in Washington, D.C. on August 9-10, 2016, for a public dialogue on prioritization and risk evaluation.  We also understand that EPA may host an industry meeting on August 11-12, 2016, to consult on fees.  The dates and topics will be confirmed when EPA makes announcements in the Federal Register.

By Lynn L. Bergeson and Margaret R. Graham

On July 14, 2016, the Environmental Law Institute (ELI) hosted an event in which the individuals and organizations critical to Toxic Substances Control Act (TSCA) reform, discussed the intricacies and challenges faced in drafting the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), the amended law, and its ultimate enactment. 

The panelists included John Pendergrass, VP of Programs & Publications, ELI (moderator), Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, PC (B&C®), Sarah Brozena, Senior Director, Regulatory & Technical Affairs, American Chemistry Council, Richard A. Denison, Ph.D., Lead Senior Scientist, Environmental Defense Fund, David Goldston, Director of Government Affairs, Natural Resources Defense Council, James J. Jones, Assistant Administrator, Office of Chemical Safety & Pollution Prevention, U.S. Environmental Protection Agency (EPA), David J. McCarthy, Chief Counsel, Subcommittee on Environment and the Economy, House Committee on Energy and Commerce, and  Senator Tom Udall, U.S. Senate (D-NM).

The overall consensus from the panelists was that the process undertaken in getting Lautenberg passed was challenging, but also inspiring and a true group effort on both sides of the aisle.  Some of the key points from the discussion included:

• On June 23, 2015, when H.R. 2576 was passed by an overwhelming 398-1, there was a great spirit of bipartisanship in the House.  McCarthy observed that this spirit of bipartisanship was especially acute on June 23, a rare event in Congress these days.
• Making a strong law that could be implemented by Jones and EPA was a high priority, and Jones’ role was “absolutely indispensable,” according to Udall who also stated, “[t]he one thing we wanted to make sure we did is not to produce a law that wasn’t going to work for [Jones] and his folks over at EPA.”  In answer, Jones stated that EPA Staff were “excited about implementation,” and have “hit the ground running.”  The law is strong, has great potential for serious reform and applicability, and is “an elegantly written, balanced and entirely implementable law that will make the world a better place,” according to Bergeson.
• In terms of cooperation and momentum, finding champions with endurance, and rewarding that support with some compromise on bill provisions created the recipe for success.  As Udall stated “[y]ou need to find champions on your environmental bills that also have political will,” who are “will to do more than just introduce a bill.  They need to deal with every stakeholder.”  Denison followed with “to move the bill through the legislative process – to get people to engage, to make changes in exchange for their support, and broaden that” was the only way to get the bill passed, and these actions were “not only to build support, but to sustain momentum over more than one Congress to ultimately get it done.”

More information on the event can be found in the Environment & Energy Daily article “Architects of TSCA Compromise See Hope for Polarized Congress” available online, through paid subscription.  A video recording of the event and other materials from the event are available to ELI Associates on ELI’s website.  ELI Associates must login to see the materials.  A full analysis of Lautenberg is available in the B&C memorandum An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA.

The House’s Office of the Law Revision Counsel has posted the U.S. Code version of the Toxic Substances Control Act, as revised by the Frank R. Lautenberg Chemical Safety for the 21st  Century Act, Public Law No. 114-182.  The U.S. Government Publishing Office (GPO) has not yet posted the official version of the public law, but is expected to soon.  The GPO version of the public law will be available at https://www.gpo.gov/fdsys/.

On July 1, 2016, Inside EPA published "Committee Jurisdiction Issues Blocked Green Chemistry From TSCA Reform," an article discussing the passage of the Toxic Substances Control Act (TSCA) law and the lack of language from previous versions boosting federal support of green chemistry. The majority of the bill was reviewed by the House Energy and Commerce Committee, but the green chemistry provision would have needed to be reviewed by the House Science, Space, and Technology Committee, further complicating the fragile House and Senate negotiations. Inside EPA's source stated: "Nobody wanted to step on anybody's toes. [...] Pretty much everything else [was] in [Energy and Commerce's] jurisdiction or was sufficiently small enough [to not raise concerns.] There were a lot of concessions on all sides." The green chemistry provision was originally added to the Senate version of the TSCA Reform, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697), by Senator Chris Coons (D-DE), and was primarily focused on funding the research and development of green chemistry.

The green chemistry provision of S. 697 called for a study of how to best incentivize sustainable chemistry research and development, as well as support "economic, legal and other appropriate social science research to identify barriers to commercialization and methods to advance commercialization of sustainable chemistry." The bill also created a working group to coordinate federal sustainable chemistry activities that would be lead by EPA's research chief and the National Science Foundation (NSF) director, as well as an advisory council to coordinate with the working group. Although green chemistry language in S. 697 did not remain in the final version of the bill, there are still supporters in Congress who are prepared to work to get the programs outlined in S. 697 into law.

An Environmental Law Institute Seminar and Webinar, Complimentary for members, $50 for non-members.

On June 22, 2016 President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, amending the Toxic Substances Control Act for the first time since its passage in 1976. While environmental organizations, public health advocates, the regulated community, and EPA have all supported updating the law since at least 2009, political challenges seemed destined to prevent comprehensive reform. Nonetheless, dedicated advocates from various stakeholder groups and committed members of Congress and their staffs overcame the hurdles and passed the most significant federal environmental law in a quarter century.

How did stakeholders and elected officials negotiate the political gridlock surrounding most recent attempts at environmental legislation? How were major issues such as the preemption of state law and financing addressed? What other roadblocks were overcome, and what can environmental, public health, and industry advocates learn from the experience?

Join us to examine the unique history of TSCA reform, and hear from people and organizations critical to its ultimate success. Speakers will share insight from the road to reform and field questions from the audience.

Panelists:
John Pendergrass, VP of Programs & Publications, Environmental Law Institute (moderator)
Lynn Bergeson, Managing Partner, Bergeson & Campbell PC
Sarah Brozena, Senior Director of Regulatory & Technical Affairs, American Chemistry Council
Richard Denison, Lead Senior Scientist, Environmental Defense Fund
David Goldston, Director of Government Affairs, Natural Resources Defense Council (invited)
Jim Jones, Assistant Administrator, Office of Chemical Safety & Pollution Prevention, US EPA
David J. McCarthy, Chief Counsel, Subcommittee on Environment and the Economy, House Committee on Energy and Commerce
Senator Tom Udall, US Senate (D-NM)

When:
July 14, 2016
2:30 PM to 4:00 PM ET

Where:
Environmental Law Institute
1730 M Street NW, Suite 700
Washington, DC 20036

And via webinar

Register: http://www.eli.org/events/story-tsca-reform

Environmental Law Institute | 1730 M Street NW, Suite 700, Washington, DC 20036 | 1.202.939.3800 | http://www.eli.org

On June 30, 2016, from 2:00 p.m. to 3:00 p.m. (EDT), the U.S. Environmental Protection Agency (EPA) hosted an informational webinar on the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Public Law No. 114-182.  A link to the presentation is available online. The topics from the webinar included:

• Major Improvements over Current Law;
• Specific Requirements for Existing Chemicals;
• Testing Authority;
• Confidential Business Information;
• Source of Funding; and
• State-Federal Partnership, among others.

More information concerning EPA’s implementation of the Act is available on EPA’s website.

On June 22, 2016, the U.S. Environmental Protection Agency (EPA) rolled out its new Frank R. Lautenberg Chemical Safety for the 21st Century Act Frequent Questions webpage.  This webpage will be a resource for Toxic Substances Control Act (TSCA) reform-related updates and implementation plans.  EPA has also posted a summary of key provisions, its six essential principles for reform of chemicals management legislation, the presentation from its informational webinar on June 30, 2016, in which EPA provided an overview of the new TSCA, and an unofficial version of TSCA as recently amended.

If you are having trouble understanding basic process flows under the new Toxic Substances Control Act (TSCA), please reference Dr. Richard A. Denison’s flow charts that depict the basic processes applicable to existing chemicals already in commerce, and applicable to new chemicals prior to market entry.  Comparisons are shown between the processes under the old and new TSCA.  Dr. Denison is a Lead Senior Scientist at the Environmental Defense Fund (EDF).  There are three flowcharts available:

• How the Lautenberg Act Works (Existing Chemicals);
• How the Original TSCA Worked (Existing Chemicals); and
• TSCA vs. Lautenberg Act (New Chemicals).

You can access the flow charts in Dr. Denison’s blog post on EDF’s Health webpage:  Understanding basic process flows under the new TSCA.