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 May 23, 2017, the U.S. Environmental Protection Agency (EPA) submitted its final rulemaking on the Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (TSCA) to the Office of Management and Budget (OMB) for review and approval.  In the proposed rule, EPA describes the processes for identifying potential candidates for prioritization, selecting a candidate, screening that candidate against certain criteria, formally initiating the prioritization process, providing opportunities for public comment, and proposing and preparing final priority designations.  EPA also incorporates all of the elements required by new TSCA, but also supplements those requirements with additional criteria it expects to consider, some clarifications intended to provide greater transparency, and additional procedural steps to ensure effective implementation.  Comments were due March 20, 2017; 70 comments were filed.  Pursuant to new TSCA, EPA must publish the final rule in the Federal Register by June 22, 2017

More information on the rule as proposed is available in our memorandum EPA Proposes Procedures to Prioritize Chemicals for Risk Evaluation under TSCA.


 

By Lynn L. Bergeson and Margaret R. Graham

On May 9, 2017, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a notice stating that it was reopening the comment period regarding whether revision to the current size standards for small manufacturers and processors, which are used in connection with reporting regulations under the Toxic Substances Control Act (TSCA) Section 8(a), is warranted.  82 Fed. Reg. 21542.  EPA is opening the comment period for another 15 days, until May 24, 2017, to provide adequate opportunity for the public to consider the results of EPA’s consultation with the Small Business Administration (SBA).  EPA’s initial request for comments was published on December 15, 2016, and comments on its initial notice were due by January 17, 2017. 

The reopening of the comment period allows for public review and comment on EPA’s December 7, 2016, consultation request to the SBA on the adequacy of the current standards, as well as the SBA Administrator’s April 5, 2017, feedback on EPA’s consultation request.  In the notice, EPA states that it had intended to add SBA’s response to the docket to give the public an opportunity to review the response to inform their comments on EPA’s preliminary determination; EPA is providing that opportunity now. 


 

By Lynn L. Bergeson and Margaret R. Graham

The amended Toxic Substances Control Act (TSCA) has ushered in new developments in testing strategies.  In March 2017, Andre E. Nel, Ph.D. (Division of NanoMedicine, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, California (UCLA); California NanoSystems Institute, UCLA (CNSI)) and Timothy F. Malloy (CNSI; UCLA School of Law; UCLA Center on Environmental and Occupational Health) published Policy reforms to update chemical safety testing:  TSCA reform empowers EPA to use modernized safety testing in the United States, in the Journal Science.  This article discusses this new “paradigm” in testing, which it states relies “largely on nonanimal, alternative testing strategies (ATS), uses mechanism-based in vitro assays and in silico predictive tools for testing chemicals at considerably less cost.”  There are technological and institutional challenges, however, that the article addresses, but the authors state they hope to provide a “cautious but hopeful assessment of this intersection of law and science.”   

The article describes five iterative components that make up the elements of ATS:  conceptual pathways; biomolecular events; screening and modeling; integrating evidence; and regulatory applications.  These components work together to inform four types of regulatory decisions: “screening to identify chemicals and nanomaterials for more extensive testing and evaluation; ranking or prioritization for further action; qualitative or quantitative risk management in support of risk management; and comparative evaluation of the hazards and risks of different substances in support of safer design.” 

Amended TSCA Section 4(h)(2) implements alternative testing methods to “promote the development and timely incorporation of new scientifically valid test methods and strategies that are not based on vertebrate animals,” and Section 4(h)(2)(A) directs EPA, by June 2018, to develop a strategic plan that will promote the development and implementation of alternative test methods and strategies to reduce, refine or replace vertebrate animal testing and provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment of chemical substances or mixtures….” 

The article states that while the amended statute seems to be only “procedural in nature” in terms of the implementation of ATS, as the statute compels EPA to facilitate development of ATS but does not obligate the agency to adopt it, two factors bode well for ATS implementation: (1) various EPA offices as well as its partner entities are “already engaged in bringing ATS into the regulatory context”; and (2) as amended TSCA mandates EPA to prioritize chemicals already in the marketplace for safety evaluations, by “specified enforceable deadlines,” which incentivizes the broader EPA chemical regulatory program to “adopt ATS for prioritization and subsequent risk evaluation of chemicals deemed high priority.”  The article references EPA’s Office of Research and Development (ORD), the Office of Science Coordination and Policy (OSCP), the new chemical review program, and EPA’s partner entity the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods as those entities engaged in ATS implementation.  


 

By Lynn L. Bergeson and Margaret R. Graham

On May 2, 2017, the U.S. Environmental Protection Agency (EPA) announced it would convene a public meeting to clarify and discuss the process of negotiated rulemaking on changes to Chemical Data Reporting (CDR) requirements for inorganic byproducts.  The meeting will be held on May 9, 2017, from 9:00 a.m. to 5:00 p.m. (EDT) and on May 10, 2017, from 9:00 a.m. to 3:00 p.m. (EDT), in Washington, D.C. at the Capital Hilton, 1001 16th Street, N.W, in the General Session Room (South American AB). 

On December 15, 2017, EPA published a notice in the Federal Register of its intention to establish a Negotiated Rulemaking Committee (NRC) under the Federal Advisory Committee Act (FACA) and the Negotiated Rulemaking Act.  81 Fed. Reg. 90843.  The NRC will implement the amended Toxic Substances Control Act (TSCA) Section 8(a)(6) requirement that EPA “enter into a negotiated rulemaking … to develop and publish, not later than 3 years after the date of enactment … a proposed rule providing for limiting the reporting requirements under this subsection for manufacturers of any inorganic byproducts, if the byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.”  EPA states that it is holding this public meeting prior to the establishment of that NRC to “exchange information and clarify a number of aspects of inorganic byproduct identification and reporting.”

EPA states that written comments can be submitted at any time during the negotiated rulemaking process, but is asking for written comments to be e-mailed to .(JavaScript must be enabled to view this email address) no later than May 8, 2017.  Parties interested in making an oral presentation at the meeting should submit requests by e-mail to .(JavaScript must be enabled to view this email address) no later than May 8, 2017, to be placed on the list of public speakers.  As there are many questions about the scope of the negotiated rulemaking and the process that the initiative will follow, interested stakeholders are urged to participate.

Information about attending this meeting and its agenda will be posted to the NRC website.  More information on the establishment of the NRC is available in our blog item EPA To Establish Negotiated Rulemaking Committee Under Amended TSCA.


 

By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham

On April 25, 2017, the U.S. Environmental Protection Agency (EPA) issued two notices in the Federal Register expressing its determination that 28 new chemical notifications are “not likely to present an unreasonable risk of injury to health or the environment.”  82 Fed Reg. 19044 (Statement of Findings for December 2016); 82 Fed. Reg. 19046 (Statements of Findings for February 2017).  The statements of findings list premanufacture notices (PMN) and microbial commercial activity notices (MCAN) regarding new polymer and biodegradable chemicals submitted to EPA under Section 5 of the Toxic Substances Control Act (TSCA).  The notices listed in the December 2016 statement of findings are:

The notices listed in the February 2017 statement of findings are:

Commentary

The publication of these two notices fulfills EPA’s obligation under TSCA Section 5(g) to publish its findings; all of these determinations had previously been posted to the EPA website.  It is to EPA’s credit that EPA has made its determinations public as soon as practicable by posting those determinations on its website.  We recognize that publication in the Federal Register often lags behind EPA’s decisions because of resource constraints and competition with other Federal Register notices.  We are pleased to see new chemicals cleared for production.

Nevertheless, EPA’s pace of approving new chemicals for the marketplace has slowed tremendously since enactment of TSCA reform.  Furthermore, these notices do not provide any line of sight on the reasons contributing to the delays, or EPA’s resolution of these issues.  To date, EPA has only published its final determinations for substances with low concerns for heath and ecological hazards.  With only 28 new chemicals approved from the time period of December 1, 2016, to February 28, 2017, EPA will need to work much faster to even come close to its annual average number of 700-800 PMN reviews and keep the backlog of cases under review from continuing to grow.


 

By Lynn L. Bergeson and Margaret R. Graham

On March 29, 2017, the U.S. Environmental Protection Agency (EPA) issued in the Federal Register a notice releasing its initial inventory report of mercury supply, use, and trade in the United States pursuant to Section 8(b)(9)(10) of the amended Toxic Substances Control Act (TSCA).  Specifically, the report is a “compilation of readily available, previously published data on the supply, use and trade elementary mercury and mercury compounds,” and its purpose is to “identify any manufacturing processes or products that intentionally add mercury.”  The report itself is available in Docket ID EPA-HQ-OPPT-2017-0127-002 on http://www.regulations.gov.  The notice states that EPA is not soliciting comments on this report.

The report states that it is focused on commodity mercury, as opposed to mercury that is handled and discarded as waste, and that in some cases the information is outdated.  The report is organized in three parts:

  • Introduction, which includes U.S. laws affecting supply and trade of Mercury; and sources of information;
  • Elemental mercury, which includes supply of elemental mercury, sources of supply, use of elemental mercury (including mercury-added products and manufacturing processes), and trade of elemental mercury; and
  • Mercury compounds, which includes supply, use, and trade of Mercury compounds.

 

By Lynn L. Bergeson

On March 15, 2017, the U.S. Environmental Protection Agency (EPA) announced it would be extending the comment period on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) proposed rule issued on January 13, 2017.  On March 16, 2017, however, EPA rescinded this extension, stating it was issued in error, but did state that it would “make every effort to consider comments received outside of the formal comment period, if provided by March 24, 2017.”  EPA is accepting comments in Docket ID EPA-HQ-OPPT-2016-0426 on the www.regulations.gov website.  More information on this proposed rule is available in our memorandum EPA Proposes Requirements for TSCA Inventory Notification (Active-Inactive).


 

By Charles M. Auer, James V. Aidala, and Lynn L. Bergeson

On February 27, 2017, the U.S. Environmental Protection Agency (EPA) announced in a Federal Register notice that it was denying a Toxic Substances Control Act (TSCA) Section 21 petition that requested regulatory action under Section 6 to “prohibit the purposeful addition of fluoridation chemicals to U.S. water supplies,” and that it was making available its response to the petition.  82 Fed. Reg. 11878.  The petition was received by EPA on November 23, 2016, and EPA had 90 days in which to respond by either granting or denying the requested action. 

  • EPA’s response was relatively comprehensive as it went through and provided its views on numerous aspects and issues at play including: 
  • EPA’s interpretation of the Section 6 provisions regarding conditions of use which asserts that TSCA requires EPA to comprehensively consider and address all conditions of use for a chemical or category of chemicals when considering and taking action under Section 6(a).  This point was first made in EPA’s proposed procedural rule for risk evaluations (82 Fed. Reg. 7562, Jan. 19, 2017) that is currently open for comment.
  • EPA’s belief that Congress, under the new law, did not intend to empower Section 21 petitioners for regulation under Section 6 to promote chemicals of particular concern and force expeditious action based on risks arising from individual uses of those chemicals (helpfully, in its response, EPA suggests use of a petition under the Administrative Procedure Act to the petitioners for such cases).
  • The scientific adequacy of the petitioners’ risks claims for the general public from exposure to fluoridation chemicals in drinking water.  EPA identified and discussed in some depth the numerous weaknesses it saw in health, exposure, and risk aspects.
  • The petitioners’ inadequate consideration of the public health benefits of fluoridation of drinking water.
  • Inadequate support by the petitioners for their belief that action was needed under TSCA rather than under the Safe Drinking Water Act, because of the latter’s purported limitations.

While comment could be offered on many of the points discussed in the decision, we limit our reactions to a few key points.  The first is that, given all of the work that is at play under new TSCA, we are frankly surprised that EPA saw the need for such a detailed and comprehensive response to the petitioners.  From our perspective, a much shorter and more focused response would have provided an adequate basis for the denial decision. 

The second is the way that EPA used its response as a platform to advocate for its interpretation that Section 6 requires that EPA consider all conditions of use in proceeding under that Section.  While this point was made in its proposed procedural rule for conducting risk evaluations, that rule was, as indicated, only a proposal and, moreover, it was issued under the prior Administration.  This decision, however, because it can be legally challenged by the petitioners, equates to a judicially reviewable act as the petitioners may commence a civil action in federal district court to compel EPA to initiate a rulemaking as requested in the petition.  Interesting, too, is the fact that the decision was issued under the new Trump Administration.  Given that the response was signed less than a month after the Inauguration, we do not want to over-interpret its significance (perhaps EPA was merely “reiterating” rather than “advocating” its position of record).  We also note in passing that it was signed on the same day that the new Administrator was sworn in (February 17).

Commentary

EPA’s response in this case is expansive and detailed, not only with respect to what EPA concluded the claimed risks of fluoride to be, but also regarding the considerable detail on what the agency apparently has concluded are required elements to qualify as sufficient to grant a Section 21 petition for TSCA Section 6(a) action in the future.  The granularity of the discussion is extraordinary.

That EPA disagreed over the possible risks of fluoride is not the most interesting part of the notice.  EPA’s response includes what in essence is the following argument about what is required to make a Section 21 argument that EPA can grant:  the petition must include a complete risk evaluation, including an analysis of all conditions of use, showing how the TSCA risk standard is exceeded, before EPA would grant the petition. 

EPA explicitly states, for example, that if a petition showed that a chemical use clearly exceeds the TSCA risk standard, and did not include all the conditions of use, EPA would still deny the petition to initiate action to control the risk.  The notice states (at 11880):

  • EPA recognizes that information on a single condition of use, could, in certain instances, suffice to demonstrate that a chemical substance, as a whole, presents an unreasonable risk.  Nonetheless, EPA concludes that such information does not fulfill a petitioner’s burden to justify “a rule under [TSCA Section 6],” under TSCA Section 21, since the information would merely justify a subset of an adequate rule.”

So even if a chemical use is shown to cause great harm, it would not merit EPA granting the petition since it is not a complete risk evaluation as EPA wishes to define it.  The notice explains EPA’s rationale for this position, essentially arguing that since EPA must assess “all conditions of use” in any control rule they might promulgate, then any outside petition must include all of the same homework before it can be granted.

This seems to obviate the very purpose of Section 21 petitions for Section 6 action, which in the past has been viewed as one way for the public to identify risks of concern to EPA which, for whatever reason, may not be on EPA’s radar.  This asserted view, that only a comprehensive risk evaluation considering all conditions of use will suffice, presents a very high threshold for action -- and seemingly an impossibly high threshold to move EPA to act.

The petitioners in this case may decide to challenge the EPA decision.  Activists concerned about the possible risks of fluoride have in the past been persistent and dogged about their cause.  In this decision, however, there is potentially more than a disagreement over possible risks of fluoride; there might also be arguments over what is or is not sufficient for Section 21 petitions to be granted, or possibly about EPA’s general interpretation, as elaborated in the denial notice and in the risk evaluation procedural rule, that new TSCA does not provide discretion for EPA to evaluate less than all conditions of use in new actions under Section 6.


 

Charles M. Auer and Oscar Hernandez, Ph.D. 

The U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced on its website on February 9, 2017, that it has established the Science Advisory Committee on Chemicals (SACC).  EPA was required to form the SACC within one year after enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  The timing is interesting given that the deadline for public comments on the nominees was January 9, 2017, and the EPA Administrator appointed the 18 experts a mere eight days later on January 17 (a full five months ahead of the Congressional deadline), yet the announcement was held until its posting, over three weeks later, on February 9.  It thus is the case that the Obama Administration took very prompt steps to ensure that formation was completed during its period in office, perhaps in an effort to select a membership more to its liking and preferences. 

Based on our quick review of the affiliations of the 18 experts selected for the SACC, this seems to be the case.  Of the members, nine are associated with academic institutions, four with industry (with two from the pharmaceutical industry, one from a trade association (Toy Industry Association), and one a former Dow Chemical Company employee currently with Underwriters Laboratories), two with non-governmental institutions (American Cancer Society and the Humane Society), and three with federal and state government.  While there are no members hailing from an environmental advocacy group, similarly there are no members currently affiliated with a chemical company.

Regarding backgrounds, there is an emphasis on expertise associated with exposure and response research on susceptible populations, with nine members having explicit or related expertise on this topic, six of which are experts from academia.  In contrast, the panel does not seem to include a breadth of experience in exposure or risk assessment.  There are two members who previously chaired EPA’s Children’s Health Protection Advisory Committee, a group that in our view is better known for advocacy than rigorous science.    

As many readers will know, the chemical industry had offered critical comments on the slate of nominees that was announced by EPA in the December 9, 2016, Federal Register notice, but little consideration seems to have been given to those comments.  At a minimum, it seems self- evident that the current membership would not have been the selection made under the Trump Administration.  How all of this will play through under the new Trump Administration is yet to be seen but could get interesting.


 

By Lynn L. Bergeson and Margaret R. Graham

On February 9, 2017, the U.S. Environmental Protection Agency (EPA) issued its 2017 Annual Report on Risk Evaluations.  Per Section 26(n)(2) of the amended Toxic Substances Control Act (TSCA), EPA is directed to publish an annual plan at the beginning of each calendar year identifying the chemical substances that will undergo risk evaluations during that year – both risk evaluations that will be initiated and that will be completed -- the resources necessary for completion, and the status and schedule for ongoing evaluations.

Per amended TSCA Section 6(b)(4), on December 19, 2016, EPA designated ten chemical substances for evaluation to determine whether they presented an unreasonable risk of injury to health or the environment.  Those chemicals are:

  • 1, 4 Dioxane;
  • Methylene Chloride;
  • 1-Bromopropane;
  • N-Methylpyrolidone;
  • Asbestos;
  • Pigment Violet 29;
  • Carbon Tetrachloride;
  • Trichloroethylene;
  • Cyclic Aliphatic Bromide Cluster (HBCD); and
  • Tetrachloroethylene.

The report provides an update pertaining to the risk evaluations of these ten chemicals.  Risk evaluations on these chemicals have already begun, and EPA anticipates issuing a scoping document for each of them by June 19, 2017.  The scoping document will include “the hazard(s), exposure(s), condition(s) of use, and the potentially exposed or susceptible subpopulation(s) the Administrator expects to consider in the evaluation.”  EPA has established a docket for each of the ten chemicals and is holding a public meeting on February 14, 2017, to present information on the specific uses and conditions of use for the chemicals.  EPA is currently accepting written comments and materials in the individual dockets until March 15, 2017.

Under Section 6(4)(G) of TSCA, EPA is required to complete these risk evaluations within three to three and a half years.  EPA’s initial report to Congress issued on January 18, 2017, detailed the resources it needed for completion of the risk evaluations.

More information on EPA’s proposed processes for prioritizing and evaluating chemicals beyond these first ten is available in our memoranda EPA Proposes Procedures to Prioritize Chemicals for Risk Evaluation under TSCA and EPA Releases Proposed Chemical Risk Evaluation Process under New TSCA.


 
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