By Lynn L. Bergeson and Carla N. Hutton
According to an October 26, 2021, project notification memorandum, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) plans to begin fieldwork on an audit of EPA’s process for conducting reviews of new chemicals under the Toxic Substances Control Act (TSCA). The memorandum states that the audit “is self-initiated based on OIG’s oversight plan for fiscal year [(FY)] 2022 and to address complaints submitted to the OIG Hotline.” The audit also addresses the following FY 2022 top management challenge for EPA: ensuring safe use of chemicals.
OIG states that its objective is to determine the extent to which EPA uses and complies with applicable records management requirements, quality assurance requirements, and employee performance standards to review and approve new chemicals under TSCA to manage human health and environmental risks. OIG plans to conduct work with the Office of Chemical Safety and Pollution Prevention (OCSPP) in EPA headquarters. According to OIG, the anticipated benefits of the audit are “improved operational efficiency and greater human health and environmental protections.”
To expedite the audit, OIG asks that OSCPP provide the following information:
- Any training materials, handbooks, or other materials related to the review of new chemicals;
- Resource allocations for the New Chemicals Review Program for FYs 2018 through 2021;
- Scopes of work for any contracts related to the new chemicals review process;
- Any OCSPP guidance under which products developed during the review of new chemicals would constitute records and how the records should be managed; and
- New Chemicals Review Program organization charts before and after the October 2020 reorganization.
As reported in our October 28, 2021, memorandum, “House Committee Holds Hearing on ‘TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act,’” Dr. Michal Ilana Freedhoff, OCSPP Assistant Administrator, has let OIG know that OCSPP will cooperate fully with its investigation.
By Lynn L. Bergeson
On August 17, 2020, EPA’s Office of Inspector General (OIG) published a report entitled Lack of Planning Risks EPA’s Ability to Meet Toxic Substances Control Act Deadlines. OIG conducted an audit to determine whether EPA met the deadlines already imposed by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) in 2016, which amended the Toxic Substances Control Act (TSCA), and whether EPA has the staff, resources, and management controls in place to meet future statutory deadlines. OIG found that while EPA met several of its TSCA deadlines, it did not complete all ten required existing chemical risk evaluations by the June 19, 2020, deadline. OIG recommends that the assistant administrator for Chemical Safety and Pollution Prevention publish the annual existing chemical plan, including the anticipated implementation efforts and required resources; conduct a workforce analysis to assess the Office of Pollution Prevention and Toxics’ (OPPT) capability to implement the TSCA requirements; and specify what skill gaps must be filled in fiscal year 2021 to meet the TSCA requirements. More information is available in our August 18, 2020, blog item.
By Lynn L. Bergeson
On June 30, 2020, EPA’s Office of Inspector General (OIG) released a report on its audit to determine whether the Safer Choice program effectively meets its goals and whether the program achieves quality standards through its product qualification, renewal, and required audit processes. OIG states that EPA’s Safer Choice program does not have formal goals included in the FY 2018-2022 EPA Strategic Plan, and the program has not reported results for FYs 2018-2019. The program does have internal, non-outcome-oriented goals, however, which it is generally achieving. The Safer Choice program’s goal is to add 200 Safer Choice products to the program and 25 chemicals to the Safer Chemical Ingredients List each year. According to OIG, in FY 2019, EPA added 265 products and 24 chemicals. OIG states that by not including formal goals for the Safer Choice program in EPA reports while continuing to receive Congressional funding and support, EPA limits not only accountability to Congress and the public, but also the extent that the program can use performance management information to make policy, budget, and management decisions. OIG notes that the Safer Choice program has general controls in place for the required Safer Choice audit process, and EPA reviews audit summaries and corrective actions provided by third-party profilers (TPP). EPA does not routinely review all supporting documentation, however, relying on TPPs to review and retain these documents. Additionally, the Safer Choice program does not have procedures in place to conduct any formal performance reviews of TPPs or oversight reviews of TPP partner audits. According to OIG, without periodic audit oversight, including full reviews of supporting documents and formal performance reviews of TPPs, EPA risks approving products that do not comply with the Safer Choice Standard. OIG recommends that the Assistant Administrator for Chemical Safety and Pollution Prevention develop and publish adequate Safer Choice program goals and performance measures, establish and implement procedures for formal audit oversight of TPPs, amend its memorandums of understanding with TPPs to require performance reviews conducted by EPA, and collect and document TPP audit supporting information.
By Lynn L. Bergeson
On August 9, 2019, the U.S. Environmental Protection Agency (EPA) published a report on its compliance with the law titled EPA Exceeded the Deregulatory Goals of Executive Order 13771. Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, includes regulatory savings goals for FYs 2017 and 2018, EPA’s deregulatory actions, and its compliance with the Office of Management and Budget’s (OMB) goal-setting requirements. EO 13771 was issued to manage costs associated with existing and new regulations established by federal agencies. Commonly referred to as the “two-for-one” EO, it required that “for every one new regulation issued, at least two prior regulations be identified for elimination.” The report addresses EPA’s regulatory compliance with the aforementioned EO, stating that “in FYs 2017 and 2018, the EPA exceeded its deregulatory expectations” and exceeded the savings goal as well. EPA clearly adds in the report that it did not develop internal guidance or management controls to implement the EO. Instead, EPA relied solely on OMB guidance. In the report, EPA recommends the enhancement of transparency regarding EO 13771 decision-making and outreach.
On August 18, 2016, the U.S. Environmental Protection Agency's (EPA) Office of Inspector General (OIG) released a report stating that EPA has not complied with federal requirements to study the effects of the Renewable Fuel Standard (RFS). The report, "EPA Has Not Met Certain Statutory Requirements to Identify Environmental Impacts of Renewable Fuel Standard," found that while EPA is required to provide a report to Congress every three years on the impact of biofuels, there has not been a report since 2011. It was also determined that EPA's Office of Air and Radiation has not analyzed or addressed any negative air quality impacts of RFS despite anti-backsliding requirements, and that EPA has not followed through on a commitment to update a 2010 lifecycle analysis (LCA).
EPA has stated that it plans to complete a report on the impact of the RFS by the end of 2017, and has agreed to corrective actions and timelines to address the rest of the issues brought up in the report. Environmental groups expect that the land-use change models used in the new study will show that the environmental impacts of biofuel production will outweigh the benefits of biofuels. Bob Dinneen, President of the Renewable Fuels Association (RFA) disagrees, stating that the RFA is confident that the new studies "will show that biofuels like ethanol are significantly reducing greenhouse gas emissions, even above the threshold reductions." Reevaluating the environmental impact of the RFS with newer science is critical for all fuel stakeholders, as well as for EPA to make well-informed policy decisions going forward.