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.
EPA Posts Agenda and Discussion Document for December 11, 2017, Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations Meeting
On November 14, 2017, the U.S. Environmental Protection Agency (EPA) released the agenda and meeting materials for its December 11, 2017, Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations under the Toxic Substances Control Act (TSCA) meeting. EPA states that during this meeting, it will describe goals, guiding principles, and possible approaches for identifying potential candidate chemicals for prioritization; and take comment on possible approaches. Under amended TSCA, EPA is required to establish processes for prioritizing and evaluating risks from existing chemicals. The meeting materials include:
EPA Posts Agenda and Other Meeting Materials for December 6, 2017, New Chemicals Review Program Implementation Meeting
On November 9, 2017, the U.S. Environmental Protection Agency (EPA) released the agenda and meeting materials for its December 6, 2017, New Chemicals Review Program Implementation meeting. NOTE WELL: This is a critically important meeting for companies that innovate in the chemical space and are now preparing Toxic Substance Control Act (TSCA) Premanufacture Notifications (PMN) or will in the future. EPA states that this meeting will update and engage with the public on EPA’s progress in implementing changes to the New Chemicals Review Program as a result of the 2016 amendments to TSCA, and will include a discussion of EPA’s draft New Chemicals Decision-Making Framework. The meeting materials include:
More information on the subsequent Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations meeting on December 11, 2017, is available in our blog item EPA Schedules Two Meetings to Discuss TSCA Implementation Activities, Requests Comments.
On November 6, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register in which it will announce two meetings to discuss implementation activities under the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 20th Century Act, as well as request public comments. The meetings are:
Online requests to participate in either meeting must be received on or before December 5, 2017. Both meetings will be held at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., in Washington, D.C., and will be available by remote access for registered participants. EPA states that more information on the specifics of the meetings will be made available in the dockets and on EPA’s website prior to the meeting.
On October 26, 2017, the U.S. Environmental Protection Agency (EPA) announced it would be hosting a public meeting on November 2, 2017, from 9:00 a.m. to 5:00 p.m. (EST) to obtain input from interested parties and the public on its development of a Strategic Plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing. EPA is required under Section 4(h) of the Toxic Substances Control Act (TSCA), as amended, to develop this Strategic Plan by June 22, 2018. EPA states that it “will consider input from the meeting and from written comments to develop a draft Strategic Plan that will be shared with the public for comment.”
EPA has posted materials for the meeting to inform the Strategic Plan and that can be used for discussion and comment on its website, including:
EPA is requesting input about the draft Strategic Plan to be shared during the meeting and in the form of written comments that may be submitted to Docket No. EPA-HQ-OPPT-2017-0559 on www.regulations.gov; comments must be received no later than 60 days following the meeting. Registration for the meeting and further information is available on EPA’s Alternative Test Methods webpage.
On October 26, 2017, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a proposed rule on reporting requirements for the Toxic Substances Control Act (TSCA) mercury inventory. 82 Fed. Reg. 49564. Under TSCA Section 8(b)(10)(B), the mercury inventory, which includes mercury “supply, use, and trade” in the United States, is required to be published every three years. Information on the 2017 mercury inventory report is available in our blog item "EPA Releases Inventory Report of Mercury Supply, Use, and Trade in the U.S."
Through this proposed rule, EPA is on its way to delivering timely on its mandate under TSCA Section 8(b)(10)(D) to promulgate a rule within two years of the enactment of new TSCA (by June 22, 2018) that will require “any person who manufactures [including import] mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process” to make periodic reports to EPA to assist in the preparation of the mercury inventory.
TSCA Section 8(b)(10)(C) further directs to “identify any manufacturing processes or products that intentionally add mercury; and … recommend actions, including proposed revisions of Federal law or regulations, to achieve further reductions in mercury use.” The proposed rule, however, states that “[a]t this time, EPA is not making such identifications or recommendations.”
The proposed rule requests comments on several changes, including:
EPA also requests comments on the proposed timelines and reporting deadlines; and on the proposed interpretations of activities to be considered as part of supply, use, and trade of mercury in the United States -- as described below.
For those who will need to report, EPA proposes the following reporting periods and deadlines:
EPA’s proposed interpretations of activities to be considered as part of the supply, use, and trade of mercury in the United States are as follows:
Comments on the proposed rule are due by December 26, 2017.
On October 25, 2017, the Senate Environment and Public Works (EPW) Committee confirmed the nominations of four U.S. Environmental Protection Agency (EPA) officials: Michael Dourson, Ph.D., for Assistant Administrator (AA) of the Office of Chemical Safety and Pollution Prevention (OCSPP); William Wehrum, Esquire, for AA of the Office of Air and Radiation (OAR), Matthew Leopold, Esquire, for General Counsel, and David Ross, Esquire for AA of the Office of Water (OW). Dourson and Wehrum, the more contentiously debated nominees, were confirmed along party lines with 11 votes (Committee Republicans) to 10 (Committee Democrats). The nominees must now face a vote by the full Senate.
More information on the EPW Committee hearing held on October 4, 2017, and on the nominees is available on our blog under key word nomination.
The U.S. Senate Committee on Environment and Public Works (EPW) has rescheduled its Committee Business Meeting to vote on nominees to the U.S. Environmental Protection Agency (EPA) for October 25, 2017, at 10:00 a.m. (EDT). The EPA nominees are: Michael Dourson, Ph.D., for Assistant Administrator (AA) of the Office of Chemical Safety and Pollution Prevention (OCSPP); William Wehrum, Esquire for AA of the Office of Air and Radiation (OAR), Matthew Leopold, Esquire, for General Counsel, and David Ross, Esquire for AA of the Office of Water (OW).
More information on the nominees, including a recap of the confirmation hearing, is available on our blog under key word nomination.
On October 18, 2017, the Senate Environment and Public Works (EPW) Committee postponed a scheduled business meeting to vote on the nominations of four U.S. Environmental Protection Agency (EPA) officials: Michael Dourson, Ph.D., for Assistant Administrator (AA) of the Office of Chemical Safety and Pollution Prevention (OCSPP); William Wehrum, Esquire for AA of the Office of Air and Radiation (OAR), Matthew Leopold, Esquire, for General Counsel, and David Ross, Esquire for AA of the Office of Water (OW).
The EPW Committee did not give a reason for the postponement nor announce a new date for the meeting, but it is being reported that EPW Committee members, including Senators Tammy Duckworth (D-IL), Joni Ernst (R-IA), and Chuck Grassley (R-IA), have reservations regarding Wehrum’s confirmation due to increasing friction with EPA on biofuels and the renewable fuel standard (RFS). On October 16, 2017, 33 Senators on both sides of the aisle sent a letter to Administrator Pruitt regarding the proposed Renewable Volume Obligations (RVO) for advanced biofuel for 2018 and biomass-based diesel for 2019, stating the proposed volumes “could have a negative impact on jobs and economies” as they “would hold the biomass-based diesel volume for 2019 stagnant at 2.1 billion gallons and decrease the advanced biofuel volume for 2018 to 4.24 billion gallons.”
As mentioned in our blog item “Senate EPW Committee Hearing on Nominations of EPA Officials,” during the October 4, 2017, hearing, Dourson was questioned and criticized the most heavily, followed by Wehrum.
More information is available on our blog under key word nomination.
On October 15, 2017, California Governor Jerry Brown signed California Senate Bill (S.B.) 258, the Cleaning Product Right to Know Act of 2017, which will require manufacturers of cleaning products to disclose certain chemical ingredients on the product label and on the manufacturer’s website. More information on S.B. 258 is available in our memorandum “California Bill Would Require Disclosure of Cleaning Product Ingredients” and on our blog under key word cleaning products.
Bergeson & Campbell, P.C. (B&C®) will soon be releasing a detailed memorandum S.B. 258 to be available on our regulatory developments webpage.
California Governor Brown Expected to Sign the Cleaning Product Right to Know Act of 2017 (S.B. 258); New York State to Release Household Cleaning Product Disclosure Program
It is widely reported that California Governor Jerry Brown imminently will sign California Senate Bill (S.B.) 258, the Cleaning Product Right to Know Act of 2017, which would require manufacturers of cleaning products to disclose certain chemical ingredients on the product label and on the manufacturer’s website. The final version of S.B. 258 was passed by the California Senate on September 13, 2017, by a vote of 27 to 13. The California Assembly passed the bill by a vote of 55 to 15, with nine votes not recorded, on September 12, 2017. Brown has until October 15, 2017, to sign the bill. The online disclosure requirements would apply to a designated product sold in California on or after January 1, 2020, and the product label disclosure requirements would apply to a designated product sold in California on or after January 1, 2021. More information on S.B. 258 is available in our memorandum “California Bill Would Require Disclosure of Cleaning Product Ingredients.”
It is also being reported that the State of New York’s Department of Environmental Conservation’s (DEC) Division of Materials Management will soon release formally a similar initiative, the Household Cleaning Product Information Disclosure Program. This program will require manufacturers of domestic and commercial cleaning products distributed, sold, or offered for sale in New York State to furnish information regarding such products in a certification form prescribed by the Commissioner, and is expected to require disclosure of many more chemicals than S.B. 258. The period for comments on the draft certification form and guidance document related to the program ended on July 14, 2017.
Bergeson & Campbell, P.C. (B&C®) will soon be releasing a detailed memorandum on both developments to be available on our regulatory developments webpage.
On October 12, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register announcing the cancellation of the fourth meeting of the Negotiated Rulemaking Committee for Chemical Data Reporting (CDR) requirements for inorganic byproducts (Reg Neg Committee) scheduled for October 25-26, 2017. 82 Fed. Reg. 47423.
During their September 13-14, 2017, meeting, the members of the Reg Neg Committee concluded that further dialogue within the Committee context would be unproductive, and that the fourth meeting was not necessary. EPA is, however, still providing the public an opportunity to weigh in on the legislative directive to reduce the CDR reporting burden for inorganic substances that are recycled, while maintaining EPA’s access to exposure information needed for risk assessment purposes. The notice states that the Reg Neg Committee docket will remain open until December 11, 2017, to allow for public comment.
The Reg Neg Committee was established to respond to the legislative mandate under Section 8(a)(6)(A) of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which states:
The [EPA] Administrator shall enter into a negotiated rulemaking … to develop and publish … a proposed rule providing for limiting the reporting requirements, under this subsection, for manufacturers of any inorganic byproducts, when such byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.
During the first set of Reg Neg Committee meetings, EPA stressed its desire to implement the outcome of the Reg Neg Committee work during the next CDR reporting cycle in 2020. To achieve this timeline, the Committee would need to reach a consensus on an approach or approaches by the October 2017 meetings. While several different stakeholder organizations offered proposals for consideration, it became clear to Committee members during the September 14-15, 2017, meeting that those proposals would not have consensus support because they either required considerable further refinement and discussion beyond the October 2017 timeframe; did not provide EPA with appropriate exposure information needed for risk assessment; or did not adequately achieve the mandated goal of limiting reporting requirements.
It is unclear if EPA will be able to complete the myriad of tasks needed to take a proposal received during the public comment period to final implementation before the 2020 CDR reporting cycle, as this would require EPA to complete a thorough analysis of additional proposals, consider potential impacts to the EPA offices, develop a proposed rulemaking, obtain public review and comment on the proposal, issue a final rulemaking, and provide clear and detailed guidance on the new approaches for reporting on recycled inorganic products prior to the 2020 CDR reporting cycle.
On October 4, 2017, the U.S. Senate Committee on Environment and Public Works (EPW) held a hearing on the nomination of four U.S. Environmental Protection Agency (EPA) officials:
More information on the backgrounds of these nominees is available in our blog item Senate EPW Committee to Hold Hearing on Nominations of EPA Officials. Some of the highlights from the hearing portions on each of the nominees are below. Dourson was questioned and criticized the most heavily, followed by Wehrum.
Michael Dourson, Ph.D., for AA of OCSPP
Dr. Dourson faced a barrage of criticism and questions from several EPW Committee members. The first was from Senator Sheldon Whitehouse (D-RI), who stated that Dourson had relied on underrated exposure data when he was studying the dangers of smoking for Phillip Morris. Senator Tammy Duckworth’s (D-IL) line of questioning was equally aggressive, referring to certain work Dourson conducted in Chicago as “pseudoscience” when he concluded there was no risk of adverse health effects. Senator Cory Booker (D-NJ) claimed that the nomination of Dourson for a position that seeks to protect families from pesticides and toxic chemicals was “shocking,” as his track record has shown him to be a “corporate lackey” working only for the results that suit the corporations for which he conducted the assessments.
Senator Kirsten Gillibrand (D-NY) was brought to tears recalling the fate of her constituents in Hoosick Falls, NY, regarding their experiences with perfluorooctanoic acid (PFOA) in the water supply. Gillibrand asked Dourson whether he believed PFOA has been linked to kidney cancer and if he would uphold EPA’s standards for PFOA exposure. Dourson replied that PFOA has been linked to some forms of cancer, science has progressed, and new standards are necessary.
Senator Jeff Merkley (D-OR) asked Dourson point blank whether chlorpyrifos has been linked to brain damage in children, as Dourson has worked on the safety aspects of this chemical for the chemical manufacturing community. Dourson replied that he was aware of studies indicating some association and that the studies making these associations were part of a collaborative project that included government scientists. Merkley noted Dourson’s involvement with several chemical trade groups and questioned whether he could be impartial.
Many of the Committee members asked why his recommendations on safe exposures to certain chemicals, including chlorpyrifos, trichloroethylene (TCE), and 1,4-dioxane, were many times higher than those of EPA’s standards. Dourson’s response was that EPA in some instances does not use the most up to date science and data. Dourson stated that he is committed to using the most credible and up to date science, as well as independent peer review, which is why many of his assessments differ from those at EPA. He also noted that the use of good science should be the touchstone of everything that EPA does and is committed to working to ensure that the best science is considered and reviewed “even for the most vulnerable in our population,” through a transparent and a collaborative process.
Ranking Member Senator Tom Carper (D-DE), Senators Kamala D. Harris (D-CA), Ed Markey (D-MA), Merkley, and Booker all asked Dourson to recuse himself from working on any chemical issues on which he had been contracted to work in the past on industry’s behalf, claiming that to do less would be unethical and pose a danger to the health and welfare of the American public. Dourson replied that he would do what was requested of him by the EPA ethics officials, and that he will bring “new science and thinking” into the Agency.
Senator Marion Rounds (R-SD) requested that Dourson keep Congress apprised on implementation of the Toxic Substances Control Act (TSCA), which Dourson confirmed he would do.
William Wehrum, for AA of OAR
In his opening statement, Wehrum signaled his intent to follow the “clear agenda” set by President Trump and EPA Administrator Scott Pruitt. He also pledged to adhere to three key objectives set forth by Administrator Pruitt. First, he noted that EPA’s role is to administer laws faithfully and to avoid the temptation to bootstrap its own powers and tools through rulemaking. Second, he stated that EPA must “acknowledge, respect, and promote the critical role of the states in implementing Federal environmental laws and in protecting human health and the environment.” Third, he emphasized the important role that the public plays in the regulatory process.
Ranking Member Senator Carper provided a particularly harsh critique of Wehrum’s fitness for office. Although stating that he believed Wehrum to be a good person, he opined that he did not think him an appropriate choice for the OAR post, stating that “he defers too frequently to industry, suppresses scientific information, and declines to respond to Congressional inquiry.” During a second round of questioning, Carper asked Wehrum to defend actions that, in Carper’s view, demonstrate that he is not faithfully committed to implementing the Clean Air Act (CAA).
Democratic Senators’ questions to Wehrum belied their doubts about his adequacy to serve as the AA, while Republican committee members’ questions unsurprisingly were less severe. When asked about potential conflicts, Wehrum noted that he would be required to comply with comprehensive ethics rules, if confirmed. Senator James Inhofe (R-OK) cited a court decision on EPA’s Mercury and Air Toxics Standards (MATS) establishing emission limits for coal-fired power plants, and that the decision compels EPA to consider the costs of compliance in setting such standards. To this Wehrum replied that EPA “absolutely” must follow the law and implement two goals: to protect human health and the environment and to promote economic growth.
Senator Merkley asked whether Wehrum believed that human activity is the major factor in climate change. Wehrum responded that he believed it was a factor, but that human activity was not clearly the major factor.
David Ross Esquire, for AA of OW, and Matthew Leopold, Esquire, for General Counsel
In stark contrast to the cross-examination endured by Dourson and Wehrum, Committee Members directed only a few, soft ball questions to David Ross and Matthew Leopold, the nominees for AA of OW and EPA General Counsel, respectively. Ross currently serves as an Assistant Attorney General and Director of the Environmental Protection Unit for the Wisconsin Department of Justice. His water quality law and policy career also includes positions with the Wyoming Attorney General’s Office and the Wyoming Water and Natural Resources Division, as well as positions held in private environmental law practice. Given Ross’ extensive experience in state government, it came as no surprise that his testimony emphasized the importance of cooperative federalism and the need for EPA to reach “outside the beltway” and improve its collaboration with state regulators. Ross acknowledged that there are divergent views on how to best manage U.S. water resources, and that he is committed to identifying approaches that will protect public health and the environment without hindering economic growth. Ross is likely to be confirmed without much resistance, although it is unclear at this time when his nomination will be scheduled for a Senate floor vote.
Leopold is currently Of Counsel at Carlton Fields Jorden Burt, P.A., in their government law and consulting practice group. He previously served as General Counsel for the Florida Department of Environmental Protection from 2013 to 2015. Leopold’s testimony included expressions of his respect for environmental protection and the rule of law, the pride he has taken in helping to restore the Everglades ecosystem, and his work on reparations related to the Deepwater Horizon oil spill in the Gulf of Mexico.
Some press outlets are reporting that Dourson’s nomination may be at risk. Given the simple majority vote needed to progress to a full Senate vote, this is by no means clear. What is clear is that the hearing yesterday was as emotional as we have viewed in a long time, and a vivid depiction of how environmental issues, particularly issues involving chemicals and exposure to them, remain divisive, emotional, and political.
The U.S. Senate Committee on Environment and Public Works (EPW) has rescheduled the full committee hearing on four U.S. Environmental Protection Agency (EPA) nominations to Wednesday, October 4, 2017, at 10:00 a.m. (EDT). The four nominations are:
More information on the nominees is available in our blog item Senate EPW Committee to Hold Hearing on Nominations of EPA Officials.
On September 25, 2017, Petitioners Safer Chemicals Healthy Families and Environmental Defense Fund (EDF) (collectively Petitioners) in Ninth Circuit Case Nos. 17-72260 and 17-72501 (regarding review of the Toxic Substances Control Act (TSCA) framework rule Procedures for Prioritization of Chemicals for Risk Evaluation) filed a joint opposition to the U.S. Environmental Protection Agency’s (EPA) motion to transfer to the Fourth Circuit and hold cases in abeyance. On September 14, 2017, EPA filed a motion for these Ninth Circuit cases to be moved to the Fourth Circuit where there is currently another challenge to a TSCA framework rule (Alliance of Nurses for Healthy Environments, et al. v. EPA, Case Nos. 17-1926, et al.; Petition for Review of Procedures for Chemical Risk Evaluation under TSCA). Petitioners oppose EPA’s request for the case to be moved to the Fourth Circuit, stating that “Congress expressly gave Petitioners the right to select a forum” and “eleven of the fifteen Petitioners elected to file their petition in [the Ninth Circuit] … now believe that both sets of petitions should be consolidated in this Court.” The Motion to Intervene of American Chemistry Council, et al. on EPA’s behalf is still pending. On September 25, 2017, EPA filed a response to the motion to intervene stating that they took no position on it. The Petitioner’s briefs in both cases are still due October 30, 2017.
On September 28, 2017, in Fourth Circuit Case Nos. 17-1796, et al. (referenced above), the court granted the Motion to Intervene on EPA’s behalf of American Chemistry Council, et al. A new briefing schedule has still not been set.
On September 29, 2017, in D.C. Circuit Case No. 17-1201 (EDF v. EPA; Petition for Review of TSCA Inventory Notification (Active-Inactive) Requirement), EPA filed a motion to extend deadlines in scheduling order, stating that “in light of the potential for other parties to file additional petitions in this Court until October 24, 2017, the parties now jointly request that the Court extend all deadlines in the Court’s September 5, 2017, order by an additional 35 days.” The court has not ruled on EPA’s request yet; if it denies it, the briefing schedule will begin on October 5, 2017.
On September 26, 2017, the U.S. Environmental Protection Agency (EPA) announced that it has launched the Smart Sectors program in the Office of Policy. 82 Fed. Reg. 44783. Based on EPA’s Sector Strategies program, the Smart Sectors program “will re-examine how EPA engages with industry in order to reduce unnecessary regulatory burden, create certainty and predictability, and improve the ability of both EPA and industry to conduct long-term regulatory planning while also protecting the environment and public health,” according to the notice. The industry sectors EPA will initially seek to work with are: aerospace; agriculture; automotive; cement and concrete; chemical manufacturing; construction; electronics and technology; iron and steel; oil and gas; ports and shipping; and utilities and power generation. A pre-publication notice issued on September 28, 2017, scheduled for publication on September 29, 2017, identified also the industry sectors of forestry and paper products; mining; and ports and marine (and deleted ports and shipping).
Under this program, EPA will designate staff-level points of contact who will act as liaisons among industry trade associations and companies, EPA program and regional offices, state and local governments, and other stakeholder groups. The sector liaisons will focus their attention primarily on three main areas: building relationships and improving customer service to sectors; developing additional expertise in each industry’s operations and environmental performance; and informing the planning of future policies, regulations, and EPA processes. EPA anticipates that participating industries will benefit from coordinated, cooperative, and constructive problem-solving with government.