The attorneys, scientists, policy experts, and regulatory advisors of Bergeson & Campbell, P.C. (B&C®), The Acta Group (Acta®), and B&C® Consortia Management, L.L.C. (BCCM) endeavor year-round to keep you informed on key developments as they happen, and prepared for looming changes and deadlines, to help you maintain compliance and competitive advantage as you market your products throughout the world. As the new year begins, we offer you this look back at the top stories of 2016 (as measured by clicks, reads, and shares by readers of our blogs and e-mails), a year that was full of surprises and dramatic shifts -- many of which will play out well into the new year.
June 22, 2016
TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA
September 22, 2016
Proposition 65: OEHHA Adopts Revisions to Its Proposition 65 Warning Regulations
August 8, 2016
TSCA Reform: Proposed Changes to SNUR Procedures Would, Perhaps Inadvertently, Result in Disclosure of CBI to Third Parties/Possible Competitors
June 29, 2016
TSCA Reform: EPA Publishes First Year Implementation Plan
April 8, 2015
K-REACH: List of Priority Existing Substances Submitted for Consultation
December 20, 2016
TSCA: EPA Amends Procedures for TSCA Section 6 Rulemaking
January 6, 2016
EPA Releases Preliminary Risk Assessment for Neonicotinoid Insecticide Imidacloprid
January 8, 2016
EPA Sued Over Guidance Classifying Seeds Coated with Neonicotinoid Insecticides as Treated Articles Exempt from Registration under FIFRA
February 10, 2016
Bayer Announces That It Will Not Submit Voluntary Cancellation Requests for Flubendiamide
October 19, 2016
Brazil Delays Promulgation of Final Industrial Chemicals Regulation
October 6, 2015
EPA Announces Revisions to Its Worker Protection Standard
September 28, 2016
EPA Announces Regulatory Determinations on MCANs and PMNs
January 13, 2016
EPA Denies SDA Nomenclature Petition, But Options for Adding Biobased Sources Remain Open
December 1, 2016
Brexit -- An Overview of Transformative Developments and Their Potential Impact on European Chemical Laws
Top Articles Authored by B&C:
Kathleen M. Roberts, Richard E. Engler, Ph.D., Charles M. Auer, Lynn L. Bergeson, "An Analysis of Section 8 of the New Toxic Substances Control Act," BNA Daily Environment Report, August 9, 2016.
Lynn L. Bergeson, Charles M. Auer, "An Analysis of TSCA Reform Provisions Pertinent to Industrial Biotechnology Stakeholders," Industrial Biotechnology, Volume 12, Issue 4, August 2016.
Charles M. Auer, "Old TSCA, New TSCA, and Chemical Testing," BNA Daily Environment Report, August 16, 2016.
L. Bergeson, B. Auerbach, L. Campbell, T. Backstrom, S. Dolan, J. Vergnes, R. Engler, J. Bultena, K. Baron, C. Auer, "The DNA of the U.S. Regulatory System: Are We Getting It Right for Synthetic Biology?," Woodrow Wilson International Center for Scholars Synthetic Biology Project Report, October 15, 2015.
Coming first quarter 2017 from ABA Books:
Lynn L. Bergeson, Charles M. Auer, New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation, American Bar Association (2017).
By Lynn L. Bergeson and Molly R. Blessing
As noted in our blog posting on November 16, 2016, the U.S. Environmental Protection Agency (EPA) announced on December 1, 2016, that its Office of Pollution Prevention and Toxics (OPPT) will hold a public meeting on December 14, 2016, from 9:00 a.m. to 3:00 p.m. (EST) to update the public on changes to the New Chemicals Review Program under the Toxic Substances Control Act, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (TSCA). Note the time change from EPA’s previous announcement of this public meeting; the meeting time has been extended to end at 3:00 p.m. instead of the original 12:00 p.m. Reportedly, the response to EPA’s earlier notice was quite robust so EPA has extended the public meeting by three hours.
EPA states that it will “describe its review process for new chemicals under the amended statute, as well as discuss issues, challenges, and opportunities that the Agency has identified in the first few months of implementation.” Interested parties will have the opportunity to comment “on their experiences with the New Chemicals Review Program, including submittal of pre-manufacture notices (PMNs), microbial commercial activity notices (MCANs), and significant new use notices (SNUNs) under section 5 of the law.” Information obtained during this meeting and from submitted written comments will be considered as EPA works to “implement the new requirements and improve the efficiency of its review process under TSCA.”
In-person and webinar registration is available now. EPA is requesting that interested parties register by December 13, 2016. Written comments will be accepted via www.regulations.gov under Docket EPA-HQ-OPPT-2016-0658 and must be submitted by January 14, 2017.
More information on new chemicals review under amended TSCA is available in our memorandum TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA, as well as on the Bergeson & Campbell, P.C. website under Regulatory Developments: TSCA.
As noted in our earlier blog, given the considerable impact of new TSCA on EPA’s New Chemicals Program, this public meeting is a must attend for TSCA stakeholders. Interested parties should come to the meeting with thoughtful questions and clear expectations as to what stakeholders can usefully share with EPA at the meeting. This could be the first of several such meetings to help interested parties understand the processes OPPT is developing in response to new TSCA, add greater transparency to those processes, and to assist EPA as appropriate with implementing the new law.
One point in particular that we draw attention to is a sentence at the top of page 86714 in the Federal Register notice describing the affirmative determinations that initially are tied to unreasonable risk determinations, then goes on to claim that there is an alternative concerning “insufficient information to allow for a determination.”
Pursuant to the amended law, EPA is now required to make an affirmative determination as to whether or not the new use or new chemical presents, may present, or is not likely to present an unreasonable risk of injury to health or the environment, or, alternatively, if there is insufficient information to allow for a determination.
This reading of the law is plainly at odds with the text that clearly states (Section 5(a)(1)(B)) that EPA has to “make a determination under subparagraphs (A), (B), or (C) of paragraph (3).” The insufficient information provision appears at Section 5(a)(3)(B)(i). and, thus, “insufficient information” is both included within (B) and is a determination. We also note that in discussing the affirmative determinations, EPA has omitted discussion of the substantial production/exposure determination at Section 5(a)(3)(ii)(II).
While this may only represent an error in drafting the notice, it is also possible that it indicates a basic misunderstanding of the new chemicals provisions, a view that may find support in some of the decisions recently communicated to our clients in “action letters” on Section 5 notices.
The September 2016 issue of the Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter is now available. This newsletter is prepared by the American Bar Association’s (ABA) Section of Environment, Energy, and Resources, and edited by Lynn L. Bergeson. Several professionals from Bergeson & Campbell, P.C. (B&C®) contributed articles to this issue of the newsletter.
Articles in this special edition of the September 2016 issue are exclusively focused on Toxic Substances Control Act (TSCA) reform. The articles include:
- From the Chair;
- From the Editor;
- New TSCA and EPA's Enhanced Testing Authority;
- New Chemicals under New TSCA;
- Is the Section 5 Review Period Fixed or Flexible in New TSCA?;
- New TSCA -- Existing Substances;
- Implementing the 2016 TSCA Amendments;
- 2017 “Reset” of New TSCA Inventory Will Affect All Chemical Users, Not Just Manufacturers;
- Changes Regarding Confidential Information in New TSCA;
- Preemption under New TSCA;
- New Fees Provisions in New TSCA;
- Weight of Evidence in New TSCA;
- PBT Actions under New TSCA; and
- New TSCA and “Articles.”
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.
||Fatty alcohols-dimers, trimers, polymers
Lubricant and lubricant additive
||Depolymerized waste plastics
||Intermediate for use in manufacture of polymers
Lubricant and lubricant additive
||Propyl silsesquioxanes, hydrogen-terminated
Lubricant and lubricant additive
||Organic modified propyl sisesquioxane
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.
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.
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)
July 14, 2016
2:30 PM to 4:00 PM ET
Environmental Law Institute
1730 M Street NW, Suite 700
Washington, DC 20036
And via webinar
Environmental Law Institute | 1730 M Street NW, Suite 700, Washington, DC 20036 | 1.202.939.3800 | http://www.eli.org
By Lynn L. Bergeson and Margaret R. Graham
On June 29, 2016, the U.S. Environmental Protection Agency (EPA) posted an Implementation Plan that outlines EPA’s plans for early activities and actions under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, legislation that significantly amends many of the provisions of the Toxic Substances Control Act (TSCA). The amended TSCA has been identified as Public Law Number (Pub. L. No.) 114-182. EPA notes that the new law imposes new responsibilities on EPA, while providing “comparatively short” deadlines to implement them. EPA “takes these responsibilities and deadlines seriously,” and intends for the Implementation Plan to be a roadmap of the major activities on which EPA will focus during the initial year of implementation. EPA organizes the Implementation Plan by the statutory timeframes during which the activities must be completed, rather than by what is of importance to EPA. EPA states that the Implementation Plan is a living document, and EPA will further develop it over time. EPA cautions that the Implementation Plan “is NOT intended to be a comprehensive listing of all requirements in the new law.”
Bergeson & Campbell, P.C. (B&C®) is pleased that EPA is making strong early efforts to communicate and engage with stakeholders about its early implementation of the new TSCA and its thinking regarding specific provisions. Completing the items listed in the Implementation Plan represents a prodigious amount of work for EPA over the coming months and years. Stakeholders will need to be prepared to respond thoughtfully to rules, lists, and process descriptions as they appear in the Federal Register, or as they are posted.
More information on EPA’s Implementation Plan is available in our memorandum TSCA Reform: EPA Publishes First Year Implementation Plan.
An in-depth memorandum of the reformed Toxic Substances Control Act (TSCA), TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA, includes an initial overview, a summary of information on the timing of various activities under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) as related to enactment and other important milestones, and a more detailed discussion of the changes in Lautenberg relative to TSCA as they relate to these and other provisions. This and other Bergeson & Campbell, P.C. (B&C®) memoranda regarding TSCA reform are available on the B&C website.
In a June 22, 2016, blog post on The Hill's Congress Blog, Lynn L. Bergeson laid out four reasons why the American public has reason to celebrate the signing into law of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, “a comprehensive and vastly improved domestic chemical management law”:
- Reformed Toxic Substances Control Act (TSCA) strikes the requisite balance between Congressional specificity and Agency discretion.
- Reformed TSCA addresses the law’s most celebrated deficits.
- Reformed TSCA gives the U.S. Environmental Protection Agency (EPA) authority to do its job: manage chemical risks.
- Reformed TSCA ensures greater transparency and public engagement in the chemical evaluation process.
Read the full blog post at The Hill: TSCA reform: renewing public confidence in chemical control.
In-House Counsel Beware: TSCA Reform Impacts Everyone, an article by Lynn L. Bergeson, on Law360, outlines the extensive revisions to the Toxic Substances Control Act (TSCA) that will impact legal practices and business operations, due to the new TSCA law, the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The content includes:
- TSCA Reform, What Just Happened?;
- The New TSCA and the New Normal;
- How the New TSCA Will Impact Product Manufacturers; and
- A list of seven “need-to-know” aspects for in-house counsel regarding how the new law works, when these impacts will occur, and how best to be prepared for them.
On June 7, 2016, the Senate passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) by voice vote and sent it to President Obama for signature. As reported in our May 26, 2016, memorandum, "An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA," the Act includes new requirements in Sections 4, 5, 6, and 8 of the Toxic Substances Control Act (TSCA). These new requirements, among others, will need to be met in promulgating currently proposed regulations, as well as in proposing/promulgating future regulations.
One important change in this regard is the way that Lautenberg changes the requirements on the U.S. Environmental Protection Agency (EPA) when it includes articles within the scope of Section 5(a)(2) Significant New Use Rules (SNUR). Several relatively recent SNURs, as proposed, included imported/processed articles within their scope and would be affected by this amendment if the article provisions are retained in a final rule. Examples include proposed SNURs on certain polybrominated diphenylethers (PBDE), toluene diisocyanates (TDI), and long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemicals.
One interesting question to consider is the need for EPA to re-propose these SNURs if it intends to retain the requirements on imported/processed articles in the final rule. If these provisions are retained, it appears that EPA would need to re-propose the rule at a minimum to satisfy the requirement at Lautenberg Section 5(a)(5) that EPA make an affirmative finding that the reasonable potential for exposure to the chemical through the article or category of articles justifies notification.
In addition, EPA's Spring 2016 Regulatory agenda lists several SNURs under TSCA that are at the proposed rule stage, including SNURs for alkylpyrrolidone products and certain uses of trichloroethylene (TCE). These rulemakings would need to address the Lautenberg changes in the proposal.
The Spring 2016 Regulatory agenda also lists three proposed rulemakings under TSCA Section 6(a), and a TSCA Section 4 test rule. The former will be affected by Lautenberg while the latter may be affected depending on the approach taken as discussed in our memorandum.
Read the full memorandum, TSCA: What Effect Will the TSCA Amendments Have on Proposed and Future Rulemakings?, online.