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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:
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.
According to press reports, Nancy Beck, Ph.D., DABT has been hired as the Principal Deputy Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). Dr. Beck holds a doctorate in environmental health from the University of Washington. For the past five years she served as the Senior Director for Regulatory Science Policy at the American Chemistry Council (ACC). For a decade prior to ACC, she was an analyst within the White House’s Office of Management and Budget (OMB).
Despite Dr. Beck’s compelling credentials, the appointment has displeased some stakeholders. Dr. Beck has been a staunch critic of how EPA conducts chemical risk assessments and its Integrated Risk Information System (IRIS). President Trump is proposing to eliminate IRIS; it thus is unlikely that Dr. Beck would revive or rely upon it in implementing the recently revised Toxic Substances Control Act (TSCA). Less than two months ago, Dr. Beck provided testimony before the Senate Homeland Security and Government Affairs Subcommittee on Regulatory Affairs and Federal Management calling for changes to EPA’s risk assessment processes.
A trio of recent internal U.S. Environmental Protection Agency (EPA) memoranda are providing insight into how EPA intends to implement President Trump’s review and potential pogrom of EPA regulations. Virtually no program or regulation appears to be secure from the chopping block. Many stakeholders in industry and other sectors may be alarmed to see programs that are of benefit to them assigned a slot in the guillotine. Supporters of these programs, thus, would be wise to educate senior EPA officials to help them understand the benefits of those programs or regulations, and save them from elimination. These internal memoranda demonstrate that the regulatory dismantling of EPA’s programs is being robustly carried out by EPA. Those stakeholders who wish to save a program benefitting their interests should act immediately to educate EPA. The three memoranda are:
More information on these memoranda are available in our full memorandum Internal EPA Memoranda Outline Approach for Regulatory Deconstruction; Stakeholders Have the Opportunity to Seek to Protect Programs at Risk.
On Wednesday, April 12, 2017, from 11:00 a.m. to 12:30 p.m. (EDT), the American Bar Association’s Section of Environment, Energy, and Resources will be hosting a teleconference on this very topic, entitled “What Happens Now at EPA: Assessing the Executive Orders and Upcoming Regulatory Reform.” Registration is available online.
On March 28, 2017, Senators Chris Coons (D-DE), Shelley Moore Capito (R-WV), Steve Daines (R-MT), and Gary Peters (D-MI) announced that they will serve as co-chairs of the newly formed Senate Chemistry Caucus. Senators John Boozman (R-AR), Joe Donnelly (D-IN), John Neely Kennedy (R-LA) and Joe Manchin (D-WV) have also agreed to join the Caucus. Senator Coons’ press release states that the Senate Chemistry Caucus will provide “a bipartisan forum for Senators to work together on issues dealing with the science of chemistry, the nation’s chemical business sector and their importance to our economy and the central role they play in the creation of innovative products vital to everyday life,” and that the group will work with their colleagues in the Senate to “underscore the importance of employing sound science to create effective public policy and to promote initiatives that encourage the development of chemical manufacturing and a new generation of chemists in the U.S. through world-class education and research programs.”
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:
On March 8, 2017, Senator James Lankford (R-OK) introduced S. 578, the “Better Evaluation of Science and Technology Act” or “BEST Act,” a bill that would amend title 5 of the United States Code, commonly referred to as the Administrative Procedure Act (APA), to “provide requirements for agency decision making based on science.” Although the BEST Act does not refer to the recently amended Toxic Substances Control Act (TSCA), it is apparent that it plans to implement the same science standards stipulated in amended TSCA, for all federal agencies that use “scientific information” (which the bill does not define) in their rulemakings, including the U.S. Environmental Protection Agency (EPA). Section 2 of the BEST Act uses language quoted verbatim from TSCA Section 26, subsections (h) Scientific Standards, (i) Weight of Scientific Evidence, and (j) Availability of Information.
S. 578 was one in a package of regulatory improvement bills that Lankford introduced on March 8, 2017, which his press release stated were “aimed at improving the federal rulemaking process so the final regulations work better for the American people.” Lankford is a vocal critic of some agencies’ practices regarding scientific integrity, stating that “agencies occasionally use hidden science to support their regulatory decisions instead of transparent conclusions, data, and methods,” and that, instead, “Agencies should use the best available science that has been peer-reviewed by an independent third-party, make sure conclusions are verifiable and reproducible, and assure the data is transparent and publically available.”
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).
On March 10, 2017, the U.S. Environmental Protection Agency (EPA) announced that its Office of Pollution Prevention and Toxics (OPPT) would be hosting two webinars covering the use of the Central Data Exchange (CDX) for upfront confidential business information (CBI) substantiation. Per EPA’s notice on January 19, 2017, the statutory requirements for substantiation of CBI claims will change effective March 21, 2017, for Toxic Substances Control Act (TSCA) submissions. In preparation for this change, OPPT revised the CDX TSCA reporting applications to allow for upfront substantiation of CBI claims.
OPPT’s first webinar will be March 15, 2017, at 1:00 p.m. (EDT) and the second will be on March 21, 2017, at 1:00 p.m. (EDT). EPA states that these webinars will cover technical aspects of making upfront substantiations within the CDX reporting applications, and that OPPT would appreciate help in identifying participants that currently use CDX reporting applications or will do so under the new requirements to participate in these events.
Registration is available online. The webinars will be limited to the first 1,000 registrants and registration will close at 11:00 a.m. (EDT) on the date of each webinar. After the webinar, OPPT will post the webinar materials on its Confidential Business Information under TSCA webpage. More information on the statutory requirements for substantiation of CBI claims is available in our blog item EPA Issues Guidance On Substantiation Requirements For CBI Claims Under TSCA.
On March 6, 2017, the White House’s Office of Management and Budget (OMB), via the Office of Information and Regulatory Affairs (OIRA), issued Memorandum: Spring 2017 Data Call for the Unified Agenda of Federal Regulatory and Deregulatory Actions, a memorandum for regulatory policy officers at executive departments and agencies and managing and executive directors of certain agencies and commissions, with the subject: Spring 2017 Data Call for the Unified Agenda of Federal Regulatory and Deregulatory Actions. Per EO 12866 (Oct. 4, 1993), federal agencies are directed to prepare a “Regulatory Plan (Plan) of the most important significant regulatory actions that the agency reasonably expects to issue in proposed or final form in that fiscal year or thereafter,” which they usually do semi-annually, in the spring and the fall. This memo reiterates the directives of past executive orders on the regulatory agendas, but also includes new directives and focus, referring largely to the directives in the January 30, 2017, Executive Order (EO), Reducing Regulation and Controlling Regulatory Costs.
The memorandum states that the Unified Agendas should “describe all regulations under development or review during the 12 months following publication. Agencies should include, at a minimum, any plans to publish or otherwise implement an Advance Notice of Proposed Rulemaking (“ANPRM”), a Notice of Proposed Rulemaking (“NPRM”), or a Final Rule,” but also requests them to reflect attention to the following:
In an effort to “facilitate the fiscal year 2018 regulatory budget planning process,” the memorandum requests that spring 2017 submissions also include “a preliminary estimate of the total costs or savings associated with each of your planned fiscal year 2018 significant regulatory actions and offsetting deregulatory actions.” The memorandum also lists suggested steps that it states will improve an agency’s Unified Agenda, including:
Agencies must submit all of their Unified Agenda materials by March 31, 2017.
EPA Denies TSCA Section 21 Petition on Fluoride Chemicals in Drinking Water; Provides Response to Petition
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.
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).
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):
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.
On March 1, 2017, President Trump’s Executive Order (EO) 13777, Enforcing the Regulatory Reform Agenda, issued on February 24, 2017, was published in the Federal Register. 82 Fed. Reg. 12285. This EO follows closely on the heels of his previous EO concerning government regulations (EO 13771), but is different in that it is intended to further and enforce President Trump’s EO as well as EO’s issued in prior administrations, instead of creating an entirely new set of directives. EO 13777 directs the head of every agency (except those receiving a waiver) to designate an agency official as its Regulatory Reform Officer (RRO), who will “oversee the implementation of regulatory reform initiatives and policies to ensure that agencies effectively carry out regulatory reforms,” including the following initiatives and policies:
The EO also establishes Regulatory Reform Task Forces (RRTF), consisting of the agency RROs and other designated agency officials, which will evaluate existing regulations and make recommendations to the agency head regarding their repeal, replacement, or modification. Each RRFT is tasked with identifying regulations that:
Within 90 days of the EO, the RRTFs are also directed to provide a report to the agency head detailing the agency’s progress toward the following goals:
Agencies that generally issue very few or no regulations may be eligible for a waiver, but the agency head must file a request with the Director of the Office of Management and Budget (OMB) for a waiver, and waivers can be revoked at any time. More information on EO 13771 and OMB’s Guidance on same is available in our blog items EPA Issues Report to Congress on Implementing Amended TSCA Provisions, President Trump Issues Memo and Order on Reducing Federal Regulations and OMB Issues Guidance on Implementation of “One In, Two Out” Executive Order.
On March 6, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register reopening the comment period on the risk evaluation scoping efforts under the Toxic Substances Control Act (TSCA) for the ten chemical substances that were designated on December 19, 2016:
The prepublication version is available on the Federal Register website. The initial notice, issued in the Federal Register on January 19, 2017, announced a public meeting which took place on February 14, 2017, and solicited “comments to receive input and information to assist the Agency in its efforts to establish the scope of risk evaluations under development for the ten chemicals substances.” This notice will extend the comment period for 14 days, from March 1, 2017, to March 15, 2017, in response to a request from the interested public.
More information is available in our blog items EPA To Hold Public Meeting on Uses and Conditions of Use for the Initial Ten Chemicals to be Evaluated under TSCA Section 6 and EPA Announces Initial List of TSCA Section 6 Chemicals for Risk Evaluation.
On February 21, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice delaying the effective date from March 20, 2017, to March 21, 2017, of the notice issued on January 19, 2017. 82 Fed. Reg. 11218. The February 21 notice appears to correct a miscalculation of the 60-day freeze period required under the Regulatory Freeze Pending Review memorandum issued on January 20, 2017, to the notice EPA issued on January 19, 2017, titled Statutory Requirements for Substantiation of Confidential Business Information (CBI) Claims Under the Toxic Substances Control Act (TSCA). 82 Fed. Reg. 6522. Counting calendar days is never easy.
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.
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:
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.