Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.
The U.S. Environmental Protection Agency (EPA) proposed on July 28, 2016, revisions to the regulations governing significant new uses of chemical substances under the Toxic Substances Control Act (TSCA) with revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standard (HCS) occasioned by OSHA’s March 2012 final rule modifying the HCS to conform to the United Nations’ (U.N.) Globally Harmonized System of Classification and Labelling of Chemicals (GHS), changes to OSHA’s Respiratory Protection Standard, and the National Institute for Occupational Safety and Health (NIOSH) respirator certification requirements pertaining to respiratory protection of workers from exposure to chemicals. EPA states that it is also proposing changes to regulations based on issues that it identified, as well as issues raised by public commenters, for significant new use rules (SNUR) previously proposed and issued under these regulations. Additionally, EPA claims to propose a “minor” change to reporting requirements for premanufacture notices (PMN) and other TSCA Section 5 notices. EPA states that it expects the changes “to have minimal impacts on the costs and burdens of complying, while updating the significant new use reporting requirements to assist in addressing any potential effects to human health and the environment.” Comments are due September 26, 2016.
The revisions include:
Although the notice downplays them, the proposal raises significant and complex issues. There may well be good reasons for several of the proposed changes. The minimal discussion provided in the notice and the lack of adequate public debate having occurred prior to its issuance raise troubling questions about the legal basis for, scope of, and complexity of the proposed changes, some of which may apply retroactively. The confusion the proposal can be expected to cause could have been avoided had adequate discussion preceded its publication, or at the least EPA could have raised these issues in the proposed rule’s preamble to focus stakeholders’ attention appropriately.
More information is available in our memorandum TSCA: Proposed Revisions to Significant New Use Rules Reflect Current Occupational Safety and Health Standards.
On July 26, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register soliciting a second round of comments on the burdens and value of information it periodically collects addressing significant new use rules (SNUR) for existing chemicals. Specifically, EPA submitted a request to renew the approval of an existing information collection request (ICR), Toxic Substances Control Act (TSCA) Section 5(a)(2) SNURs for Existing Chemicals, to the Office of Management and Budget (OMB). This notice provides chemical manufacturers and other interested parties a second opportunity to comment on certain questions, specifically: whether the agency accurately estimated the burden of responding to SNURs that it issues for chemicals in commerce; whether the agency could minimize the burden; and whether the information it collects is necessary.
The first ICR was issued on September 2, 2015, and comments were due November 2, 2015. Only two comments were filed in response to the initial ICR, by the American Chemistry Council (ACC) and the Society of Chemical Manufacturers & Affiliates (SOCMA), two trade associations. ACC and SOCMA stated in their comments that EPA underestimated the burdens its SNURs impose on chemical manufacturers and their customers.
This renewed ICR states that EPA estimated that six companies would be affected by its new use rules for existing chemicals, creating an estimated total burden of 1,025 hours per year and a cost of $100,595.
Comments are due August 25, 2016.
SNURs are deeply unpopular to some in the chemical community and welcomed outcomes of the premanufacture notice (PMN) or significant new use notification (SNUN) process to others. Most would agree that the cost of compliance with a SNUR can be difficult to estimate with any degree of precision. Some of us are also of the view that TSCA, as recently amended, may result in many more SNURs given the new “determination” requirements under TSCA Section 5(a). The comment period opened by today’s Federal Register notice provides an excellent opportunity to provide comment to EPA and thus help to ensure that EPA has an accurate and current basis upon which to estimate the cost.
EPA to Host Public Meetings to Obtain Input on Amended TSCA Prioritization and Risk Evaluation Processes
On July 25, 2016, the U.S. Environmental Protection Agency (EPA) announced its intention to hold two public meetings on August 9, and August 10, 2016, to obtain input on the processes that will be used to prioritize and evaluate chemicals under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act:
The public meetings are scheduled for 9:30 a.m. to 4:30 p.m., and will be held at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., Washington, D.C. EPA states that the input obtained during these meetings will be considered as the EPA develops its proposed procedural regulations for risk evaluation and chemical prioritization. EPA is recommending that any interested participants register in advance.
More information concerning EPA’s implementation of the amended TSCA is available in our memorandum EPA Publishes First Year Implementation Plan, as well as on the Bergeson & Campbell, P.C. (B&C®) website under Regulatory Developments: TSCA.
It is critically important that stakeholders attend and participate in these meetings. While the timing is regrettable in light of vacation schedules, EPA is under intense pressure to issue rules later this year and EPA has no choice other than to keep the process moving. EPA is to be commended for scheduling these opportunities as quickly as it has, and its efforts should be acknowledged by robust stakeholder engagement.
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.
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.
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.
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.
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.
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:
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/.
Lynn L. Bergeson Quoted In Bloomberg BNA Daily Environment Report Article On The Need To Submit Thoughtful PMNs to EPA
On July 15, 2016, Bloomberg BNA Daily Environment Report quoted Lynn L. Bergeson, Managing Partner of Bergeson & Campbell P.C. (B&C®), in the article, “Give EPA Detailed New Chemical Notices, Attorneys Advise.”
On July 15, 2016, Bloomberg BNA Daily Environment Report quoted Lynn L. Bergeson, Managing Partner of Bergeson & Campbell (B&C®), in the article “Give EPA Detailed New Chemical Notices, Attorneys Advise.”
B&C Webinar Featured In Bloomberg BNA Daily Environment Report Article “Companies Need EPA to Specify Exposure Texts for TSCA Data”
On July 14, 2016, Bloomberg BNA Daily Environment Report included quotes from the B&C® and Chemical Watch webinar “The New TSCA Series Webinar 2: Impacts on New Chemical Programs.”
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.
And via webinar
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Lynn L. Bergeson Comments On TSCA Implementation Featured In Bloomberg BNA Daily Environment Report Article “More Than 300 New Chemicals Snagged as EPA Implements Law”
Lynn L. Bergeson Comments On TSCA Implementation Featured In Bloomberg BNA Daily Environment Report Article “More Than 300 New Chemicals Snagged as EPA Implements Law”
On July 12, 2016, Lynn L. Bergeson, Managing Partner of Bergeson & Campbell (B&C®), was quoted in the Bloomberg BNA Daily Environment Report article “More Than 300 New Chemicals Snagged as EPA Implements Law.”