By Lynn L. Bergeson and Carla N. Hutton
On February 16, 2021, the National Academies of Sciences, Engineering, and Medicine (National Academies) announced the availability of a report entitled The Use of Systematic Review in EPA’s Toxic Substances Control Act Risk Evaluations. The U.S. Environmental Protection Agency (EPA) requested that the National Academies convene a committee to review EPA’s 2018 guidance document on Application of Systematic Review in TSCA Risk Evaluations and associated materials. In its final report, the Committee to Review EPA’s Toxic Substances Control Act (TSCA) Systematic Review Guidance Document states that it “was in strong consensus that the processes used by [the Office of Pollution Prevention and Toxics (OPPT)] do not meet the evaluation criteria specified in the Statement of Task (i.e., comprehensive, workable, objective, and transparent).” The Committee recognizes the “substantial challenges in implementing review methods on the schedule required by” the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), but concluded that those challenges “have not yet been successfully met.” The final report includes the following summary of the Committee’s general recommendations:
- OPPT’s approach to systematic review does not adequately meet the state of the practice. The Committee suggests that OPPT comprehensively reevaluate its approach to systematic review methods, addressing the comments and recommendations provided in Chapter 2 of the final report.
- With regard to hazard assessment for human and ecological receptors, the Committee comments that “OPPT should step back from the approach that it has taken and consider components” of the Office of Health Assessment and Translation (OHAT) of the National Toxicology Program, EPA’s Integrated Risk Information System (IRIS), and Navigation Guide methods that could be incorporated directly and specifically into hazard assessment.
- The Committee finds that OPPT’s use of systematic review for the evidence streams, for which systematic review has not been previously adapted, “to be particularly unsuccessful.” The Committee suggests that OPPT elaborate plans for continuing the refinement of methods, ideally in collaboration with internal and external stakeholders. The Committee also suggests that OPPT evaluate how the existing OHAT, IRIS, and Navigation Guide methods could be modified for the other evidence streams. In addition, according to the Committee, OPPT should use existing EPA guidance, such as the Guidelines for Human Exposure Assessment, the Guidelines for Ecological Risk Assessment, and the operating procedures for the use of the ECOTOXicology knowledgebase (ECOTOX). Following these existing guidelines would improve transparency of the assessments.
- The Committee recommends that EPA put together a handbook for TSCA review and evidence integration methodology that details the steps in the process. Throughout the final report, the Committee points to problems of documentation. The Committee “believes that the effort of developing and publicly vetting a handbook will pay off in the long run by making the process more straightforward, transparent, and easier to follow.”
The final report states that “[t]here is an ongoing cross-sector effort to develop and validate new tools and approaches for exposure, environmental health, and other new areas of application of systematic review,” and the Committee “strongly recommends that OPPT staff engage in these efforts.” According to the final report, the approaches used for TSCA evaluation “would benefit from the substantial external expertise available,” as well as additional transparency and acceptance by the different stakeholders as these tools are developed.
EPA published a press release on February 16, 2021, in response to the Committee’s report, announcing that it “will refine its approach to selecting and reviewing the scientific studies that are used to inform” TSCA chemical risk evaluations. According to EPA, its “ongoing effort to update its systematic review approach” is also part of its “broader efforts” to review the first ten TSCA risk evaluations. EPA states that it “is not using, and will not again use, the systematic review approach that was reviewed by the Academies.” The 2018 Application of Systematic Review document “represented EPA’s practices at that time.” According to the press release, EPA has already begun to develop a TSCA systematic review protocol in collaboration with its Office of Research and Development to incorporate approaches from the IRIS Program. EPA “expects to publish and take public comment on a TSCA systematic review protocol that will adopt many of the recommendations in the Academies’ report later this year.”
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on January 5, 2021, that it is reopening the reporting period under the Toxic Substances Control Act (TSCA) Inventory notification active-inactive rule where companies identified chemicals that were manufactured, imported, or processed in the United States during the ten-year time period ending on June 21, 2016. As reported in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules,” the final TSCA Inventory notification (active-inactive) rule established a retrospective electronic notification of chemical substances on the TSCA Inventory that were manufactured (including imported) for nonexempt commercial purposes during the ten-year time period ending on June 21, 2016, with provision to also allow notification by processors. From August 11, 2017, through October 5, 2018, chemical manufacturers and processors provided information on which chemicals were manufactured, imported, or processed in the United States over the past ten years. The reporting period included an opportunity for submitters to assert claims to retain specific chemical identities as confidential business information (CBI). In May 2020, EPA posted an interim list of chemicals expected to lose their CBI status and move to the public portion of the TSCA Inventory. In its January 5, 2021, announcement, EPA states that it since become aware of “submitter confusion and issues regarding CBI claims” during the initial reporting period. EPA is allowing companies to submit, amend, or withdraw filings under the TSCA Inventory notification (active-inactive) rule to maintain existing CBI claims for specific chemical identity. The reporting period will reopen 30 days after publication in the Federal Register and run for 60 days after that date.
Chemical manufacturers and processors have just over four months to submit Chemical Data Reporting (CDR) data by the November 30, 2020, close of the reporting period. To assist companies in that process, Bergeson & Campbell, P.C. (B&C®) affiliate The Acta Group (Acta®) developed CDR Cross-Check™, an ingenious and cost-efficient tool to identify whether a company’s chemicals are subject to CDR reporting and if so, at what reporting threshold.
CDR Cross-Check will identify:
- Whether the chemical is listed as active or inactive;
- Whether the chemical was subject to specific TSCA regulatory actions in 2016;
- Whether the chemical is exempt; and
- What the reporting thresholds are based on the updated data released by the U.S. Environmental Protection Agency (EPA) on May 29, 2020.
Visit the CDR Cross-Check page on the Acta website for a sample report and information on how to use CDR Cross-Check.
By Lynn L. Bergeson and Carla N. Hutton
On May 12, 2020, the U.S. Environmental Protection Agency (EPA) released the signed final rule updating the definition of small manufacturers, including a new definition of what is considered a small government, used to determine reporting and recordkeeping requirements under the Toxic Substances Control Act (TSCA). According to EPA, the updated definitions will reduce reporting burdens on chemical manufacturers and small governments while maintaining the agency’s ability to receive the information it needs to understand exposure to chemical substances manufactured in the United States. The final rule makes a technical correction to the small manufacturer reference at 40 C.F.R. Section 704.104 for hexafluoropropylene oxide, which only includes a rule-specific small processor definition and not a small manufacturer definition. When reviewing the small manufacturer size standards, EPA found this to be an “inadvertent error.” The final rule also updates the current small manufacturer definition in the Preliminary Assessment Information Rule (PAIR) at 40 C.F.R. Section 712.25 to align it with the updated small manufacturer definition at 40 C.F.R. Section 704.3.
EPA notes that the updated definitions will apply to the Chemical Data Reporting (CDR) rule reporting period beginning June 1, 2020, and will impact certain reporting and recordkeeping requirements for TSCA Section 8(a) rules. EPA states that the final rule is based on 2018 dollars to ensure that the definition is as up to date as possible at the time of promulgation. The final rule will be effective 30 days after publication in the Federal Register. EPA has posted the pre-publication version of the final rule on its website.
More information on CDR reporting is available in our May 13, 2020, blog item, “New Reporting Procedure for Co-Manufacturers under TSCA CDR Rule May Catch Certain Manufacturers Off Guard,” and our March 19, 2020, memorandum, “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”
By Lynn L. Bergeson and Christopher R. Blunck
One of several changes to the Toxic Substance Control Act (TSCA) Chemical Data Reporting (CDR) Rule, issued in final on April 9, 2020, is that in the 2020 cycle, the U.S. Environmental Protection Agency (EPA) has changed the way that toll manufacturing must be reported. In this cycle, EPA will not accept reporting from only the contracting manufacturer in situations where a company contracts with another company (i.e., a toll manufacturer) for the production of chemicals. As in years’ past, EPA states in its final rule that if no report is filed, both the contracting and producing companies will be held liable if no reporting occurs. Under past CDR cycles, EPA would accept reporting from either the contracting manufacturer or the producing (formerly referred to as “toll”) manufacturer. In 2020, EPA has stated in multiple fora that for the 2020 reporting period, EPA will only accept manufacturing details from the actual producers, even if manufacturing was contracted by another company. This change may come as a surprise, especially to producing companies that heretofore may not have reported under the CDR Rule and instead relied on the contracting company to do so.
EPA stated in the preamble to the final CDR rule that it chose to include two different reporting methodologies for a co-manufacturing situation, indicating that the methodologies are based on a desire to reduce reporting burden and maintain flexibility for both the contracting and producing company. EPA noted that the companies must work together to select between the methodologies for preparing their CDR methodologies. The two methodologies for reporting, codified at 40 C.F.R. Section 711.22(c), are:
(1) The contracting company initiates the required report for that site [defined by EPA at 40 C.F.R. §711.3 as the location where the chemical substance is physically manufactured for chemical substances co-manufactured] as the primary submitter. The contracting company must indicate on the report that this is a co-manufacturing situation, notify the producing company, and record the production volume domestically co-manufactured as set forth in §711.15(b)(3) and processing and use information set forth in §711.15(b)(4). Upon notification by the contracting company, the producing company must also record the production volume domestically co-manufactured and complete the rest of the report as prompted by e-CDRweb.
(2) Upon written agreement between the contracting company and the producing company, the producing company completes the full report for the co-manufactured chemical. The contracting company supplies the information not otherwise known to or reasonably ascertainable by the producing company.
In both cases, the producing company (toll manufacturer) must provide the manufacturing details. There is no mechanism for the contracting company to submit the entire Form U.
More information on the final CDR rule is available in our March 19, 2020, memorandum, “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”
By Lynn L. Bergeson and Carla N. Hutton
On March 17, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a final rule amending the Chemical Data Reporting (CDR) rule. According to EPA, the amendments are intended to reduce the burden for certain CDR reporters, improve the quality of CDR data collected, and align reporting requirements with the Frank R. Lautenberg Chemical Safety for the 21st Century Act’s (Lautenberg Act) amendments to the Toxic Substances Control Act (TSCA). EPA states that some of the key revisions include:
- Simplifying reporting, including allowing manufacturers to use certain processing and use data codes already in use by many chemical manufacturers as part of international codes developed through the Organization for Economic Cooperation and Development (OECD);
- Updating requirements for making confidentiality claims to align with the requirements in amended TSCA; and
- Adding reporting exemptions for specific types of byproducts manufactured in certain equipment.
Additionally, EPA is extending the reporting period for CDR data submitters from September 30, 2020, to November 30, 2020, to provide additional time for the regulated community to familiarize themselves with the amendments and to allow time for reporters to familiarize themselves with an updated public version of the reporting tool. The reporting period will still begin on June 1, 2020. EPA will host a webinar on Tuesday, March 31, 2020, to discuss the revised reporting requirements, provide an overview of the 2020 CDR submission period, and to give an introduction to the updated e-CDRweb reporting tool. EPA has posted pre-publication versions of the final rules amending the CDR rule and extending the reporting period. More information will be available in a forthcoming memorandum that will be posted on our website.
By Lynn L. Bergeson and Carla N. Hutton
On March 5, 2020, the U.S. Environmental Protection Agency (EPA) announced that it issued a final rule to add two strains of microorganisms to the list of microorganisms eligible for an exemption from certain reporting requirements under the Toxic Substances Control Act (TSCA). EPA states that manufacturers of new intergeneric Trichoderma reesei (strain QM6a) and Bacillus amyloliquefaciens (subspecies amyloliquefaciens) may now be eligible to undergo a streamlined review process under TSCA’s new chemicals review program with reduced TSCA fees. The final rule is intended to ensure the safety of human health and the environment while reducing regulatory burden for the biotechnology industry.
EPA states that after reviewing all relevant health and safety data, it determined that the two microorganisms can be added to the list of microorganisms eligible for exemption. Under TSCA, manufacturers of a new intergeneric microorganism may be eligible to submit an exemption request in lieu of a microbial commercial activity notice (MCAN) if the organism is on the list of species eligible for an exemption and meets other criteria. EPA is including these two microorganisms on the list because it determined that the microorganisms “will not present an unreasonable risk of injury to health or the environment provided that the other criteria relating to the introduced genetic material and the physical containment of the new microorganisms have been met.”
According to EPA, both microorganisms have a long history of safe use to produce a variety of commercial enzymes used in industrial and food-related industries. Trichoderma reesei is used by the animal feed, baking, beverages, textile processing, detergent, pulp and paper, industrial chemicals, and biofuels industries. Bacillus amyloliquefaciens has been used to produce commercial enzymes for more than 50 years. It produces carbohydrases, proteases, nucleases, xylanases, and phosphatases that have applications in the food, brewing, distilling, and textile industries.
The final rule will be effective 30 days after publication in the Federal Register.
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 Environmental Defense Fund (EDF) announced on June 17, 2019, a report entitled Toxic Consequences: Trump’s attacks on chemical safety put our health at risk. EDF notes that “[c]oncern over toxic exposures and a lack of confidence in the badly outdated chemical safety system” led to Congress passing the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) to reform the Toxic Substances Control Act (TSCA). The bipartisan bill “finally” gave the U.S. Environmental Protection Agency (EPA) “the power to strengthen health protections for American families and the environment.” EDF claims that the Trump Administration “is seeking to dismantle the new authorities and mandates under the law with the goal of shifting policies to serve the chemical industry’s agenda,” however. According to EDF, EPA has taken the following actions that undermine the Lautenberg Act:
- Approving new chemicals without regard for the law or public health;
- Ignoring real-life exposures when evaluating risks of existing chemicals; and
- Blocking or weakening bans of toxic chemicals.
EDF concludes that “without a drastic change to EPA’s current direction on chemical safety, we will be forced to endure the toxic consequences of its mistakes for decades to come.”
By Lynn L. Bergeson and Margaret R. Graham, M.S.
On April 30, 2019, the U.S. Environmental Protection Agency (EPA) announced it would be hosting two webinars for companies, organizations, and individuals required to report under the Mercury Inventory Reporting Rule of the Toxic Substances Control Act (TSCA). The final rule applies to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process (including processes traditionally not subject to TSCA, such as for the manufacture of pharmaceuticals and pesticides).
The first webinar, Mercury Inventory Reporting Rule, will provide background on reporting requirements under the final rule. It will take place on May 21, 2019, at 2:00 p.m. (EDT). The 2018 reporting year is from January 1, 2018, to December 31, 2018, and the submission deadline for the 2018 reporting year is coming up on July 1, 2019. Reporters are required to submit their information to EPA using the Mercury Electronic Reporting (MER) application for the first time on July 1, 2019, and then every three years thereafter. Based on the information collected, EPA will identify any manufacturing processes or products that intentionally add mercury and recommend actions to achieve further reductions in mercury use. Following EPA’s presentation, webinar participants will have an opportunity to ask questions on reporting requirements under the final rule. Registration is available online.
The second webinar, Mercury Electronic Reporting (MER) Application, will demonstrate how to use the online MER application through EPA’s Central Data Exchange (CDX), which is organized as a fill-in-the-blanks form with drop-down menus and lists of check-box options. It will take place on May 23, 2019, at 2:00 p.m. (EDT). Registration is available online.
More information on the Mercury Inventory Reporting Rule is available in our June 25, 2018, memorandum “EPA Publishes Final Reporting Requirements for TSCA Mercury Inventory,” and in our March 19, 2019, memorandum “EPA Releases New Tools to Help Companies Meet July 1 Mercury Reporting Requirements.”