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 Carla N. Hutton
 
Earlier this month, David Fischer joined the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) as a Deputy Assistant Administrator.  Prior to joining EPA, Mr. Fischer was most recently a partner of legal and regulatory affairs at IBEX Partners LLC, a public affairs firm.  Before his partnership at IBEX, Mr. Fischer held several senior positions at the American Chemistry Council in its Office of General Counsel and Chemical Products and Technology Division, providing legal and policy counsel on a broad range of industrial, specialty chemical, and product defense matters.  Earlier in his career, Mr. Fischer was also the Director of Environmental Health at the Association of State and Territorial Health Officials, where he led the first national assessment of state activities in lead poisoning prevention. 


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on July 15, 2019, that it will cease sending notices of deficiency to businesses that submit procedurally flawed confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA).  This is a significant change from the interpretation EPA announced in January 2017, and a company’s failure to appreciate its consequences could prove damaging.  Effective August 15, 2019, EPA will provide written notice to affected business submitters that because they submitted procedurally flawed CBI claims, including unsubstantiated CBI claims, those CBI claims are invalid, and the underlying information is not protected from disclosure under TSCA Section 14.  EPA states in the Federal Register notice issued on July 16, 2019, that under its 2017 interpretation, it undertook a “non-statutorily required practice of sending a notice of deficiency to an affected business that submitted a non-exempt CBI claim without a substantiation, providing an opportunity to correct the deficiency.”  84 Fed. Reg. 33939.  Under the new policy, EPA will provide written notice to affected business submitters that because they submitted procedurally flawed CBI claims, including unsubstantiated CBI claims, those CBI claims are invalid, and the underlying information is not protected from disclosure under TSCA Section 14.  EPA notes that unlike the notice of deficiency, this written notice will not provide affected businesses 30 calendar days to remedy their deficient CBI claims.  Instead, the written notice will inform affected businesses that their “procedurally flawed” CBI claims may be disclosed to the public without further notice.  More information is available in our July 16, 2019, memorandum, “EPA Announces Important New Policy on TSCA CBI Claims of Deficiency.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On June 28, 2019, the U.S. Environmental Protection Agency (EPA) filed its response to the non-governmental organizations’ (NGO) supplemental brief in a case challenging EPA’s prioritization and risk evaluation rules.  Safer Chemicals, Healthy Families v. EPA, No. 17-72260.  According to EPA, petitioners “have plausibly alleged standing to challenge only the definitional interpretation of ‘conditions of use’ and the two provisions still subject to EPA’s motion for voluntary remand.”  As to the remainder of petitioners’ claims, EPA maintains that their allegations “are based on hypotheticals and other non-final agency actions currently being considered by the agency.”  EPA argues that the court should dismiss petitioners’ challenges to:  (1) EPA’s preamble statements about the potential scope of future risk evaluations; (2) EPA’s regulatory provisions leaving the door open to issue early risk determinations; and (3) the remaining information-gathering provisions still at issue.  EPA states that if it “ever takes final agency actions based on the decisions Petitioners hypothesize, those would be the proper actions for Petitioners’ challenges.”
 
A coalition of industry associations filed a supplemental brief in support of EPA on June 28, 2019.  The coalition states:  “Although it is theoretically possible that EPA could exclude a use of a particular chemical that could affect the risk evaluation in a way that could cause the agency not to regulate some use of a chemical that could injure Petitioners’ members, that does not create a justiciable controversy now, before the Rules have been applied.”  (Emphasis in original.)  The coalition asks the court to dismiss the petitions for lack of jurisdiction.
 
As reported in our June 26, 2019, blog item, the U.S. Court of Appeals for the Ninth Circuit heard oral arguments on May 16, 2019, and afterward ordered petitioners to file a supplemental brief addressing why they should be allowed to bring a lawsuit against EPA.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On July 5, 2019, the U.S. Court of Appeals for the District of Columbia Circuit rejected an “invitation” to recognize liability under the False Claims Act (FCA) based on a company’s failure to meet a Toxic Substances Control Act (TSCA) reporting requirement and failure to pay an unassessed TSCA penalty.  Kasowitz Benson Torres LLP v. BASF Corp. (No. 1:16-cv-02269).  The court states that the FCA imposes civil liability on anyone who defrauds the federal government of money or property.  Under the FCA, a third party may file suit on behalf of the government and collect a “substantial” bounty if successful.  The law firm Kasowitz Benson Torres LLP (Kasowitz) filed suit in 2016, claiming that several chemical manufacturers violated TSCA by “repeatedly failing to inform” the U.S. Environmental Protection Agency (EPA) of “information regarding the dangers of isocyanate chemicals.”  Kasowitz argued that the manufacturers’ failure to disclose this information and their subsequent actions deprived the government of property (substantial risk information) and money (TSCA civil penalties and contract damages).  The court noted that Kasowitz demanded “billions of dollars in damages, even though the government openly support[ed] the defendants.”  The district court dismissed its lawsuit, and Kasowitz appealed, asking the court “to become the first court to recognize FCA liability based on the defendants’ failure to meet a TSCA reporting requirement and on their failure to pay an unassessed TSCA penalty.  We decline the invitation and affirm the dismissal.”
 
Kasowitz claimed that the defendants -- BASF Corporation, Covestro LLC, Dow Chemical Company, and Huntsman International LLC -- “manufacture isocyanate chemicals, which are used to produce various polyurethane-based materials such as paint, adhesives, rigid foam for insulation, flexible foam for mattresses and cushions, and parts for automotive interiors.”  According to Kasowitz, the defendants acquired information as early as the 1970s about the adverse health effects of isocyanate chemicals.  The companies failed to disclose this information to EPA, however, despite participating in EPA’s Compliance Audit Program.  Kasowitz argued that the companies’ TSCA violations and their failure to pay penalties for those violations deprived the government of its money and property.
 
In its analysis of Kasowitz’s claims, the court describes the allegation that the companies violated FCA’s reverse false claim provision by “knowingly conceal[ing] or . . . improperly avoid[ing] . . . an obligation to pay” money as a non-starter.  The court notes that “[‌i]t is undisputed that the EPA did not assess TSCA penalties against the defendants for failing to report substantial risk information regarding isocyanate chemicals.”  As a result, there was no FCA “obligation” for the companies to conceal or avoid.  In its decision, the court states that once EPA has taken successful administrative action, it has discretion to impose an appropriate civil penalty, including no penalty.  According to the court, two TSCA provisions make this conclusion “inescapable”:  (1) TSCA expressly grants the EPA authority to remit or otherwise decline to impose a civil penalty; and (2) TSCA itself recognizes that not every violation results in a civil penalty.  Under EPA’s Compliance Audit Program, the court states that a company that failed to report substantial risk information faced no additional penalty and was in the same position it would have been had it not participated in the Program at all.  Kasowitz also argued that the companies violated the reverse false claim provision by “knowingly conceal[ing] or . . . improperly avoid[ing] . . . an obligation to pay or transmit” property in the form of substantial risk information.  The court considered whether the TSCA obligation to inform the EPA of substantial risk information qualifies as an obligation to transmit property.  The court “conclude[d] that TSCA does not require the transmission of a property interest.  TSCA gives the EPA one -- and only one -- interest in substantial risk information: the right to be informed of it.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on June 28, 2019, announcing that the EPA Safer Choice Program is accepting submissions for its 2019 Safer Choice Partner of the Year Awards.  84 Fed. Reg. 31066.  The Safer Choice Program partners with businesses and others to help consumers and commercial buyers identify products with safer chemical ingredients, “without sacrificing quality or performance.”  Toward this end, according to EPA, the Safer Choice Program certifies products containing ingredients that have met the Program's “specific and rigorous human health and environmental toxicological criteria.”  The Safer Choice Program allows the use of its label on products that perform and contain safer ingredients, as determined by expert evaluation.  According to EPA, recognition by the Safer Choice Program represents a high level of achievement in formulating products that are safer for people and the environment.  EPA states that the purpose of the Partner of the Year Awards “is to recognize the leadership contributions of Safer Choice partners and stakeholders who, over the past year, have shown outstanding achievement in the design, manufacture, selection, and use of products with safer chemicals.”  All Safer Choice stakeholders and Program participants in good standing are eligible for recognition.  According to the notice, interested parties must inform the Program that they would like to be considered for an award and submit supporting information.  Submissions are due July 31, 2019.  EPA will recognize award winners at a Safer Choice Partner of the Year Awards ceremony in fall 2019.

Tags: Safer Choice,

 

By Lynn L. Bergeson and Carla N. Hutton
 
On June 28, 2019, a coalition of 11 state attorneys general filed a lawsuit in the U.S. District Court for the Northern District of California against the U.S. Environmental Protection Agency (EPA) for its failure to initiate an asbestos reporting rule under Section 8(a) of the Toxic Substances Control Act (TSCA).  The complaint argues that EPA wrongfully denied the states’ January 31, 2019, petition, filed under TSCA Section 21, to issue a rule for the reporting of the manufacture, import, and processing of asbestos.  More information on the petition is available in our February 1, 2019, blog item, and more information on EPA’s denial is available in our January 4, 2019, blog item.
 
According to the coalition, the rulemaking they requested is necessary under TSCA, and the denial of their petition was arbitrary and capricious and violates EPA’s obligations under TSCA.  The coalition asks the court to compel EPA to initiate a rulemaking and issue a new asbestos reporting rule to:

  • Eliminate “naturally occurring substance” as an exemption for asbestos reporting;
     
  • Require processors of asbestos, as well as manufacturers, including importers, of the chemical substance to adhere to reporting requirements;
     
  • Ensure that the impurities exemption in the Chemical Data Reporting (CDR) rule does not apply to asbestos; and
     
  • Require reporting with respect to imported articles that contain asbestos.

The coalition includes the Attorneys General of California, Connecticut, Hawaii, Maine, Maryland, Massachusetts, Minnesota, New Jersey, Oregon, Washington, and the District of Columbia.


 

By Lynn L. Bergeson and Carla N. Hutton

On June 28, 2019, the U.S. Environmental Protection Agency (EPA) released the draft risk evaluations for cyclic aliphatic bromide cluster (HBCD) and 1,4-dioxane, two of the first ten chemicals undergoing risk evaluation under the amended Toxic Substances Control Act (TSCA).  In its June 28, 2019, press release, EPA states in the draft risk evaluation for HBCD, it did not find unreasonable risk to the general population, consumers, workers, or the environment.  According to EPA, in the draft risk evaluation for 1,4-dioxane, EPA did not find unreasonable risk to the environment, but the data “show there could be unreasonable risks to workers in certain circumstances.”  EPA states:  “It is important to note that for the general population, including children, environmental statutes administered by EPA such as the Clean Air Act, the Safe Drinking Water Act, the Clean Water Act, and the Resource Conservation and Recovery Act, adequately assess and effectively manage risks from 1,4-dioxane.”

On Monday, July 1, 2019, EPA will publish a Federal Register notice announcing the availability of the draft risk evaluations and beginning a 60-day comment period.  The draft risk evaluations will be peer reviewed by the Science Advisory Committee on Chemicals (SACC) on July 29- August 2, 2019.  SACC will hold a preparatory virtual meeting to discuss the scope and clarity of the draft charge questions on July 10, 2019.


 

By Lynn L. Bergeson and Emily A. Scherer
As reported in our June 28, 2019, memorandum, on June 24, 2019, Bergeson & Campbell, P.C.(B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health (GWU) presented “TSCA: Three Years Later,” a day-long conference with leading experts exploring the current impacts of the Toxic Substances Control Act (TSCA) on science policies, challenges faced by industry, and the impacts of TSCA on regulatory policies, especially those concerning ensuring compliance and enforcement. A recording of the full conference is available online.  Our memorandum provides details regarding the session topics and presenters, including copies of the presentation where available.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On May 16, 2019, the U.S. Court of Appeals for the Ninth Circuit heard oral arguments in a case filed by non-governmental organizations (NGO) challenging the U.S. Environmental Protection Agency’s (EPA) prioritization and risk evaluation rules.  Safer Chemicals, Healthy Families v. EPA, No. 17-72260.  During oral arguments, the court asked the Natural Resources Defense Council (NRDC) whether it had standing to be before the court.  NRDC responded that it does, arguing that EPA’s rules violate the statutory requirements of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  The court suggested that petitioners could wait to see whether EPA will ignore certain uses of chemicals in its risk evaluations.  EPA maintained that petitioners were raising a challenge to a hypothetical scenario and that EPA has the legal discretion to study whichever chemical uses it sees fit.  Following oral argument, on May 16, 2019, the court ordered petitioners to file a supplemental brief addressing why they should be allowed to bring a lawsuit against EPA.  The petitioners filed their supplemental brief on June 3, 2019, arguing that they have standing because the Toxic Substances Control Act (TSCA) Framework Rules threaten their members’ concrete interests in minimizing toxic chemical exposures; they have information standing for each of their challenges to the Framework Rules; and their claims are ripe.  EPA was granted an extension and its response is due June 28, 2019.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency released on June 21, 2019, a proposed rule intended to reduce exposures to certain chemicals that are persistent, bioaccumulative, and toxic (PBT).  EPA identified five chemicals pursuant to Section 6(h) of the Toxic Substances Control Act (TSCA):  decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)), also known as tris(4-isopropylphenyl) phosphate; 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); hexachlorobutadiene (HCBD); and pentachlorothiophenol (PCTP).  The proposed rule would restrict or prohibit manufacture (including import), processing, and distribution in commerce for many uses of all of the chemicals except HCBD, for which EPA is proposing no regulatory action.  For the other four chemicals, the proposed rule includes recordkeeping requirements, as well as additional downstream notification requirements for PIP (3:1).  Publication of the proposed rule in the Federal Register will begin a 60-day comment period.  Our June 24, 2019, memorandum, “EPA Publishes Proposed PBT Chemicals Rule under TSCA,” provides a detailed review and analysis.

Tags: PBT, Section 6

 
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