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.

By Lynn L. Bergeson and Margaret R. Graham

On April 24, 2018, the U.S. - Canada Regulatory Cooperation Council (RCC) Stakeholder Group announced that a 2018 RCC Stakeholder Event will be held on June 4-5, 2018, in Washington, D.C. to “bring together senior regulatory officials, industry, and other members of the public on both sides of the border to provide progress reports on existing RCC work plans and to discuss new opportunities for regulatory cooperation.”  The announcement states that details regarding the 2018 RCC Stakeholder Event, including the registration process, will be forthcoming and to please contact .(JavaScript must be enabled to view this email address) with any questions. 

More information on the existing work plans and the RCC in general is available on the Government of Canada’s Regulatory Cooperation webpage and on our blog under key word RCC.


 

By Lynn L. Bergeson and Margaret R. Graham

On April 24, 2018, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register that it will be adding a supplemental analysis, “Supplemental Analysis of Alternative Small Business Size Standard Definitions and their Effect on TSCA User Fee Collection,” to the rulemaking docket for the User Fees for the Administration of the Toxic Substances Control Act (TSCA) proposed rule published on February 26, 2018.  EPA will also be extending the comment period for the proposed rule for an additional 30 days “to give interested parties the opportunity to consider this additional analysis and prepare meaningful comments.”  Comments will be due within 30 days of publication (by May 24, 2018).  The original comment deadline was April 27, 2018.

Regarding the supplemental analysis, EPA states that it “provides additional estimates for the impact of setting the small business definition based on an employee-based threshold.”  More information on the proposed rule is available in our February 9, 2018, memorandum “Administrator Pruitt Signs TSCA User Fee Proposal.”


 

By Lynn L. Bergeson and Margaret R. Graham

On April 19, 2018, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received the U.S. Environmental Protection Agency’s (EPA) proposed rule entitled “Strengthening Transparency and Validity in Regulatory Science.”  This new proposed rule, item 2080-AA14, has not been published in the regulatory agenda; the only information available concerning the content of this rule is its title.

 On April 11, 2018, OIRA received an advanced notice of proposed rulemaking from EPA entitled “Increasing Consistency and Transparency in Considering Costs and Benefits in the Rulemaking Process.”  The OIRA 2017 Fall Regulatory Agenda for this rulemaking, item RIN 2010-AA12, states that EPA is considering “developing implementing regulations that would increase consistency across EPA divisions and offices, increase reliability to affected stakeholders, and increase transparency during the development of regulatory actions,” and that by developing implementing regulations through a notice-and-comment rulemaking process “it will provide the public with a better understanding on how EPA is evaluating costs when developing a regulatory action and allow the public to provide better feedback to EPA on potential future proposed rules.”

 More information on regulatory agenda items is available on our blog under key phrase regulatory agenda.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency’s (EPA) April 2018 Toxic Substances Control Act (TSCA) Chemical Substance Inventory is now available.  For the first time, the Inventory includes a field designating substances that are “active” in U.S. commerce based on the following:

  • Reporting from the 2012 and 2016 Chemical Data Reporting cycles;
  • Notices of Commencement received by EPA since June 21, 2006; and
  • Notice of Activity Form A’s received by EPA through the February 7, 2018, deadline, per the TSCA Inventory Notification (Active-Inactive) Rule.

EPA states that it “carefully processed and conducted a quality check of the data to ensure duplicate entries and confidential business information were removed” from the large number of notices received under the Active-Inactive Rule.  EPA also posted a list of substances reported in a Notice of Activity Form A from February 8 through March 30, 2018.  According to EPA, this list should assist processors in determining which of their substances on the Inventory have not yet been designated as “active” to date.  Based on our review, the Inventory lists approximately 38,303 total active substances, or about 44.5 percent.  The deadline for voluntary submission of a Notice of Activity Form A by processors is October 5, 2018.

If your company is having trouble reporting through EPA’s Central Data Exchange (CDX), please contact Richard E. Engler, Ph.D. or Lynn L. Bergeson to obtain a copy of our comprehensive Guidance Materials for TSCA Inventory Notification Rulemaking.  Our TSCA experts would be pleased to assist you with the reporting process!

More information on the TSCA Inventory rulemaking and TSCA Inventory issues is available on our blog under the key phrase TSCA Inventory and on our TSCA Reform News & Information web page.  More information on EPA’s Final TSCA Inventory Notification (Active-Inactive) Rule is available in our memorandum, “EPA Issues Final TSCA Framework Rules.”  Specific information on changes in the CDX system is available in our blog item, “EPA Updates eNOA Template in CDX System.”


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA), Environment and Climate Change Canada (ECCC), and Health Canada (HC) have released an educational primer on U.S. and Canadian regulations regarding chemical substances.  EPA states that the purpose of the primer is to compile easy-to-use information for stakeholders potentially regulated under similar U.S. and Canadian regulations -- Significant New Use Rules (SNUR) in the U.S. and Significant New Activity (SNAc) provisions in Canada.  EPA, ECCC, and HC previously collaborated in the implementation of a Regulatory Cooperation Council (RCC) Work Plan on Chemicals Management that focused on SNURs and SNAcs.  The primer states that an overarching issue identified during the roundtable discussions was the need for improved outreach and education, ranging from the basics of the SNUR/SNAc programs to specific requirements for various stakeholders, especially for potentially less-informed stakeholder groups, such as foreign suppliers, and small, niche companies in the U.S. and Canada.  According to EPA, information in the primer will assist the regulated community to determine how to comply and engage their supply chains to help facilitate compliance for meeting SNUR and SNAc requirements.  The primer notes that it does not substitute for any SNUR or SNAc provisions, nor is it a rule itself.  The primer does not impose legally binding requirements on the regulated community or on EPA, ECCC, or HC.


 

By Lynn L. Bergeson and Carla N. Hutton

The National Academies of Sciences, Engineering, and Medicine released a new report on April 11, 2018, that finds that the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program has made “substantial progress” in implementing recommendations outlined by the National Academies in previous reports.  According to the April 11, 2018, press release, the transformation of IRIS began several years ago, after the release of a 2011 National Academies report that provided suggestions for creating a more systematic and transparent IRIS process.  In a 2014 report, the National Academies reviewed the changes implemented by EPA since 2011 and concluded that the improvements were considerable.  Under the Program’s new leadership, EPA asked the National Academies to review again its progress toward addressing past recommendations.  The press release states that the National Academies’ latest review, Progress Toward Transforming the Integrated Risk Information System (IRIS) Program, finds that the IRIS Program has made substantial progress in incorporating systematic-review methods into its process and assessments.  The IRIS Program has also established a systematic-review working group and engaged subject-matter experts.  According to the report, these groups should increase efficiency and consistency among assessments and improve the scientific rigor of the assessments.  Although the National Academies Committee to Review Advances Made to the IRIS Process “offers some refinements and identifies a few possibilities for further development,” the report states that “its overall conclusion is that EPA has been responsive and has made substantial progress in implementing National Academies[’] recommendations.”

 

Tags: IRIS,

 

By Lynn L. Bergeson and Carla N. Hutton

On March 22, 2018, U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt appointed 11 additional members to the Science Advisory Committee on Chemicals.  Under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the purpose of the Committee is to provide independent advice and expert consultation, at the request of the EPA Administrator, with respect to the scientific and technical aspects of risk assessments, methodologies, and pollution prevention measures or approaches supporting implementation of the Act.  According to EPA, these additional members “will increase the balance of scientific perspectives and add experts with experience in labor, public interest, animal protection and chemical manufacturing and processing to the committee.”  The additional 11 members -- three from non-governmental organizations (NGO), four from industry, and four from academia or governmental organizations -- will supplement the 18 expert members that were appointed on January 19, 2017.  The Committee will meet three to four times a year for two years, and its charter can be extended.  EPA has not yet scheduled the Committee’s first meeting.

Two of the members have reportedly declined the appointment.  Dr. Michael Wilson, National Director for Occupational and Environmental Health at the BlueGreen Alliance, “notified EPA that he was unable to accept the appointment,” according to a spokesperson for the BlueGreen Alliance.  Dr. Jennifer McPartland, Senior Scientist at the Environmental Defense Fund, has also declined the appointment.  Ruthann Rudel, Director of Research at the Silent Spring Institute, stated that she is “collecting some advice and information” and has not decided whether to accept the appointment. 


 

On April 4, 2018, the U.S. Environmental Protection Agency (EPA) announced the following management changes in its Office of Pollution Prevention and Toxics (OPPT):

  • Maria Doa, Ph.D., Director of the Chemical Control Division (CCD) at OPPT since 2011, will move to the Office of Research and Development’s (ORD) Office of Science Policy.  Prior to leading CCD, Dr. Doa was director of the National Program Chemicals Division (NPCD).
  • Lynn Vendinello, Deputy Division Director of the CCD since 2014, will serve as the CCD Acting Director on an interim basis.  Ms. Vendinello has held a number of management and supervisory positions in OPPT and EPA’s Office of Compliance.
  • Tanya Mottley, Acting Deputy Director of OPPT, will resume her leadership role as Director of NPCD.  Prior to leading NPCD, Ms. Mottley was the Director of OPPT’s Pollution Prevention Division (PPD).
  • Bryan Symmes will resume his duties as NPCD Deputy Director.
  • Tala Henry, Ph.D., Director of OPPT’s Risk Assessment Division (RAD) since 2013, will be the next Acting Deputy Director for OPPT.  Prior to leading RAD, Dr. Henry led NPCD after serving as a toxicologist in RAD and the Office of Water.
  • Cathy Fehrenbacher, now RAD Deputy Director, will serve as RAD Acting Director.   Ms. Fehrenbacher has held exposure assessment-related supervisory positions with OPPT; she began her career at EPA as a senior industrial hygienist.

These are significant leadership changes and are likely intended to maximize OPPT efficiency. We applaud OPPT’s continuing efforts to implement TSCA and the changes occasioned by the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act almost two years ago.


 

By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham

On March 28, 2018, the Superior Court of California, Los Angeles County, issued its Statement of Decision (Phase II) (Defendants’ Alternative Significant Risk Level (ASRL) Affirmative Defense) that found that the defendants failed to meet their burden of proof on their ASRL affirmative defense.  Council for Education and Research on Toxics (CERT) v. Starbucks Corporation (Starbucks), No. BC435759 (L.A. Super. Ct., filed April 13, 2010).  CERT’s (plaintiff) complaint alleged that Starbucks, along with 18 other defendants (the total later reached 91 defendants when a second action was filed (now consolidated)), that sell ready-to-drink coffee failed to provide warnings to consumers that the coffee sold contained high levels of acrylamide, a carcinogenic chemical, in violation of Proposition 65 (Prop 65).  The defendants denied the material allegations and asserted various affirmative defenses, violation of the First Amendment, and federal preemption.  According to the order, the parties did not dispute that acrylamide, listed as a carcinogen by the International Agency for Research on Cancer (IARC), and under Prop 65 since 1990, is listed by the State of California as a chemical believed to cause cancer; or that they failed to provide warnings to consumers that the ready to drink coffee they sold contained high levels of acrylamide.  

In Phase I of the trial, the court came to a similar conclusion, that defendants failed to meet their burden of proof by preponderance of evidence on their affirmative defenses of “no significant risk level,” First Amendment, and federal preemption to avoid the requirement of cancer warning labels as to the existence of acrylamide in brewed coffee.  The trial on Phase II of the case ran from September 2017 to November 2017 and post-trial briefs were filed in December 2017 and January 2018.  The order states that to have prevailed on their ASRL defense, defendants needed prove all of the below, which they failed to do:

  1. Establish that acrylamide is created by cooking or processing necessary to render the coffee safe or palatable (defendants only argued that acrylamide levels in coffee cannot be reduced at all without negatively affecting safety and palatability);
  2. Demonstrate that “sound considerations of public health” justify applying an alternative (less strict) risk level (defendants did not counter plaintiffs evidence that consumption of coffee increases harm to the fetus, infants, children, and adults; and the court found their proffered evidence that coffee itself confers some benefit to human health to be unpersuasive); and
  3. Present persuasive evidence of what would be an appropriate alternative risk level, taking into account the identified public health considerations (defendants did not conduct a quantitative risk assessment of the risk of cancer from exposure to acrylamide in coffee, necessary to prove an alternative risk level for acrylamide in coffee).

The ASRL affirmative defense is grounded on an exemption to the cancer hazard warning requirement under Prop 65, but as the defendants were not able to prevail on this defense, they will now be required to provide the Prop 65 warning language on their ready-to-drink coffee products, but the order does not specify any details regarding this.  The decision also exposes the defendants to liability in terms of millions in fines.  The defendants have until April 10, 2018, to file objections to the decision.


 

By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham

U.S. Senate Minority Leader Charles E. Schumer (D-NY) on March 20, 2018, announced that, after his intervention, representatives from the U.S. Occupational Safety and Health Administration (OSHA), the U.S. Environmental Protection Agency (EPA), and the Department of Homeland Security (DHS) are working to create new protocols for communicating and training with local governments and first responders.  OSHA, EPA and DHS will convene the Chemical Facility Security and Safety Working Group (Working Group), which will coordinate strategies, activities, policies, and communication to address concerns that there should be an immediate and more thorough improvement of OSHA’s coordination and communication systems to local municipalities and their respective stakeholders.  Specifically, the Working Group is moving forward with a new partnership between the agencies regarding the coordination of communication between state and local governments when there is a serious violation cited.  The protocol will address the lack of communication with local first responders, safety and training agreements, and coordination on information sharing about all the relevant agencies when a local company is cited for serious violations -- like the reported mishandling of Verla International’s (Verla) use of flammable liquids.  

The new protocol is intended to ensure that emergency response agencies are notified when a facility receives a serious health or environmental violation, so that they can proactively prevent accidents and prepare to respond when accidents and fires occur.  Specifically, the Working Group is tasked with:

  • Developing appropriate means for sharing information with first responders to enhance their ability to safely and effectively plan for and respond to incidents in their jurisdiction;
  • Developing tools, training, and resources to strengthen State Emergency Response Commissions and Local Emergency Planning Committees;
  • Coordinating with agencies beyond DHS, EPA, and OSHA by working with the U.S. Department of Justice, the U.S. Department of Transportation, and, in this instance, the U.S. Food and Drug Administration, as appropriate, to address incidents involving hazardous materials and the effects these incidents have on workers and communities;
  • Coordinating information sharing across the interagency community and with state, local, tribal, territorial, and private sector partners; and
  • Leveraging limited resources across all levels of government by conducting and facilitating cross-training to raise awareness of other programs.

In April 2017, OSHA cited Verla’s cosmetic factory in New Windsor, New York for improper storage of flammable liquids that resulted in several serious violations, and in November 2017 there was an explosion and fire at the factory where one worker was killed and 40 people, including seven firefighters, were injured -- a tragedy that may have been avoided had the first responders been notified of the violations and known better how to handle the situation.  Senator’s Schumer’s concerns about the lack of communication and notification stem from these events.  He states the new protocols “will provide technical expertise and tighter coordination with federal and regional first responder operations to try to make sure the lack of communication and awareness of preexisting issues faced by first responders back in November is a thing of the past.”


 
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