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

On November 15, 2021, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced the availability of its annual report summarizing what OIG considers the “most serious management and performance challenges facing the agency.” According to OIG, EPA’s top management challenges in fiscal year (FY) 2022 include:

  • Mitigating the Causes and Adapting to the Impacts of Climate Change: EPA must take a leadership role in limiting climate change and mitigating its effect on human health and the environment;
     
  • Integrating and Leading Environmental Justice across EPA and the Government: As part of its effort to integrate environmental justice across its programs, EPA must address the environmental hazards and cumulative risk facing at-risk communities and effectively communicate that risk to those communities;
     
  • Ensuring the Safe Use of Chemicals: OIG states that to protect effectively public health and the environment, EPA must be able to depend on its ability to conduct credible and timely assessments of the risks posed by pesticides, toxic chemicals, and other environmental chemical risks. According to OIG, the 2016 expansion of EPA’s regulatory authority under the Toxic Substances Control Act (TSCA) has increased the need for conducting rapid and accurate risk assessments. OIG notes that EPA must also continue to conduct registration and reregistration of “hundreds of pesticides per year, as well as assure that it is setting appropriate exposure levels for contaminants in drinking water.” Without appropriate resource and implementation plans in place to demonstrate that EPA can accomplish this work, and without the ability to conduct scientifically sound risk assessments accurately, the public’s trust and confidence in EPA’s ability to accomplish its mission of protecting human health and the environment will be at risk;
     
  • Safeguarding Scientific Integrity Principles: Science-based decisions at EPA must be based on principles of scientific integrity to ensure that human health and the environment are protected by using the best available science. EPA must develop new processes and update its regulations, policies, and guidance to protect scientific integrity. According to OIG, taking these actions will help make EPA decisions more legally defensible and maintain public trust in its decision making;
     
  • Ensuring Information Technology and Systems Are Protected against Cyberthreats: Information technology is a fundamental and essential resource for EPA to carry out its mission;
     
  • Managing Infrastructure Funding and Business Operations: EPA must effectively oversee the funding and operation of America’s water, wastewater, and other environmental infrastructure; and
     
  • Enforcing Environmental Laws and Regulations: Through enforcement, EPA ensures that regulated entities are following environmental laws and will continue to do so, as enforcement actions effectively deter future noncompliance. According to OIG, considering EPA’s limited resources, and despite potential funding increases in FY 2022, “EPA is challenged to assess its resource requirements for the enforcement program and identify innovative and cost-effective means of detecting and deterring noncompliance in the future.”

 

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 and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) published on September 30, 2020, its audit of EPA’s Toxic Substances Control Act (TSCA) Service Fee Fund financial statements for the period from Inception (June 22, 2016) through September 30, 2018.  The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) requires EPA to prepare and OIG to audit the TSCA Service Fee Fund financial statements each year.  OIG states that its primary objectives were to determine whether the financial statements were fairly stated in all material respects; EPA’s internal controls over financial reporting were in place; and EPA management complied with laws and regulations.  OIG notes that the TSCA Service Fee Fund has been designed to defray up to 25 percent of the costs associated with implementing key TSCA provisions.  According to OIG, EPA overstated expenses from other appropriations by $8.4 million.  OIG states it found that EPA made errors in multiple iterations of its calculation for expenses from other appropriations.  No significant matters involving compliance with applicable laws and regulations, contracts, and grant agreements came to OIG’s attention during the course of the audit.
 
OIG recommends that the chief financial officer:  (1) improve the management review process for calculating expenses from other appropriations to be consistent with EPA component financial statement audits and to ensure that costs support the TSCA Service Fee Fund activities; and (2) establish written policies and procedures so that expenses from other appropriations in component audits reflect actual costs.  According to OIG, EPA concurred with its recommendations and provided “acceptable corrective actions and estimated completion dates.”  OIG states that it considers the recommendations resolved with corrective actions pending.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On August 17, 2020, the U.S. Environmental Protection Agency’s (EPA) 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 the 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 has the staff, resources, and management controls in place to meet future statutory deadlines.  The Lautenberg Act required EPA to develop new rules for chemical prioritization for risk evaluation and risk evaluation for existing chemicals and to review all new chemical submissions and make a regulatory determination.  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 notes that because of statutory requirements, the number of required existing chemical risk evaluations doubled at the end of 2019, “risking the EPA’s ability to meet TSCA deadlines.”
 
OIG states that EPA’s ability to assess its TSCA workload -- and subsequently estimate the workforce levels necessary to achieve that workload -- “is critically important.”  OIG notes that the Office of Pollution Prevention and Toxics (OPPT) has not publicly identified the additional staff and resources it needs to accomplish all mandated TSCA requirements.  According to OIG, “OPPT’s resource planning is hindered by not complying with the U.S. Office of Personnel Management regulations, which requires developing a workforce plan to manage current and future workforce needs.”
 
OIG states that EPA’s program offices have not conducted a systematic workload analysis or identified workforce needs for budget justification purposes since 1987 and that this is also true for OPPT, which is responsible for implementing the TSCA amendments.  According to OIG, though OPPT expects to hire more staff members to implement the TSCA amendments in fiscal year (FY) 2020, OPPT “lacks a workforce-and-workload analysis to successfully implement and meet the 2016 TSCA deadlines.”  Additionally, OIG states, EPA’s annual plans for risk evaluations “were neither done in a timely manner nor met the statutory requirements to identify the resources needed to initiate or complete the risk evaluations for the year.”
 
OIG recommends that the assistant administrator for Chemical Safety and Pollution Prevention:  (1) publish the annual existing chemical plan including the anticipated implementation efforts and required resources; (2) conduct a workforce analysis to assess OPPT’s capability to implement the TSCA amendments; and (3) specify what skill gaps must be filled in FY 2021 to meet the TSCA requirements.  According to OIG, EPA “provided acceptable corrective actions and estimated milestone dates for all recommendations.” OIG “consider[s] these recommendations resolved with corrective actions pending.”
 


 

By Lynn L. Bergeson and Carla N. Hutton
 

As reported in our May 29, 2020, blog item, on May 28, 2020, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) issued a report entitled EPA Toxic Substances Control Act Consent Orders Need Better Coordination.  OIG conducted the evaluation to determine what actions EPA took to verify compliance with the requirements of a 2009 Toxic Substances Control Act (TSCA) Premanufacture Notice Consent Order.  OIG’s recommendations included that EPA implement a process for the Office of Enforcement and Compliance Assurance (OECA) to review and approve the terms and conditions of TSCA Section 5(e) Consent Orders that it is responsible for verifying during compliance monitoring and enforcement activities.  On August 5, 2020, OIG announced that EPA has provided an update to its response to the OIG report.  EPA states that the Office of Civil Enforcement/Waste and Chemical Enforcement Division (OECA/WCED) and the Office of Pollution Prevention and Toxics/Chemical Control Division (OCSPP/CCD) have developed a TSCA Section 5(e) Order Boilerplate that “clarifies and strengthens the provisions of the Order for New Chemical Substances.”  According to EPA, in 2020, OCSPP/CCD and OECA/WCED established and implemented a Standard Operating Procedure (SOP) to ensure that WCED, the office responsible for compliance monitoring and enforcement activities, reviews and approves the terms and conditions of TSCA Section 5(e) Orders developed by CCD.  EPA notes that the establishment of the SOP is intended to meet OIG’s recommendation.  EPA states that the Review and Approval Protocol “provides sufficient assurance that compliance and enforcement requirements in TSCA 5(e) orders will be reviewed and approved by OCSPP and OECA.”  OIG commented on EPA’s updated response, stating that it now considers this recommendation complete.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On June 30, 2020, the U.S. Environmental Protection Agency (EPA) 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 fiscal year (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 and Carla N. Hutton
 
On May 20, 2020, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report entitled Further Efforts Needed to Uphold Scientific Integrity Policy at EPA.  OIG conducted an Agency-wide survey to determine whether EPA’s Scientific Integrity Policy is being implemented as intended to ensure scientific integrity throughout EPA.  OIG received 4,320 responses (a 23.5 percent response rate), showing that 3,987 respondents were aware of or had some familiarity with the Scientific Integrity Policy.  According to OIG, among those respondents with a basis to judge, the majority (56 percent; 1,025 of 1,842) were satisfied with the overall implementation of the Policy.  OIG states that the survey also revealed some concerns with specific aspects of scientific integrity at EPA, including dissatisfaction with EPA’s culture of scientific integrity (59 percent; 1,425 of 2,402) and the release of scientific information to the public (57 percent; 1,049 of 1,842).  OIG recommends that EPA’s deputy administrator lead an effort to examine the causes associated with the scientific integrity concerns identified in the survey and communicate the results to EPA employees, including planned actions to address the causes.  OIG also made 11 recommendations to the EPA science advisor, including developing procedures for addressing and resolving allegations of scientific integrity violations, communicating the outcomes of reports of scientific integrity violations, and improving the release of scientific information to the public.  OIG states that EPA agreed with its recommendations and provided acceptable corrective actions.  According to OIG, EPA has completed two recommendations, and the others are resolved with corrective actions pending.


 

By Lynn L. Bergeson and Carla N. Hutton
 

On May 28, 2020, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) issued a report entitled EPA Toxic Substances Control Act Consent Orders Need Better Coordination.  OIG conducted the evaluation to determine what actions EPA took to verify compliance with the requirements of the 2009 Toxic Substances Control Act (TSCA) Premanufacture Notice Consent Order with DuPont (responsibilities transferred to The Chemours Company in 2015) to prevent the release of GenX chemicals in the Cape Fear River in North Carolina.  OIG notes that GenX chemicals are a type of per- and polyfluoroalkyl substances (PFAS) found in surface water, groundwater, drinking water, rain water, and air emissions.  OIG found insufficient communication and coordination between the two EPA offices responsible for developing and enforcing the consent order requirements designed to reduce risks in the manufacture of GenX chemicals.  Under the 2009 Consent Order, EPA required DuPont to determine how to recover and capture 99 percent of GenX’s manufacturing discharges and air emissions.  The Consent Order was not reviewed or approved by the Office of Enforcement and Compliance Assurance (OECA), which is responsible for conducting inspections to verify compliance, however.  Until June 2017, EPA’s actions to verify compliance with the 2009 Consent Order and new chemicals testing requirements consisted of tracking and reviewing information provided by the manufacturer.  According to OIG, following the local media coverage of the presence of GenX chemicals in the Cape Fear River in 2017, Region 4 and EPA contractors conducted EPA’s first on-site compliance monitoring inspection at the Fayetteville Works facility, which manufactures GenX.  OIG found that the Region 4 inspectors were unaware of the 2009 Consent Order and its requirements until the inspection was requested by EPA headquarters.
 
OIG recommends that EPA establish and implement processes:

  1. For OECA to review and approve the terms and conditions of TSCA Section 5(e) Consent Orders that it is responsible for verifying during compliance monitoring and enforcement activities; and
     
  2. To provide final TSCA Section 5(e) Consent Orders to regions and verify that the regions have the final consent orders.

OIG states that EPA “did not provide an acceptable corrective action for Recommendation 1, and we consider this recommendation unresolved.”  For Recommendation 2, EPA provided an alternative course of action that OIG finds acceptable.  OIG considers Recommendation 2 resolved with corrective action pending.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The Office of Inspector General (OIG) for the U.S. Environmental Protection Agency (EPA) announced on February 27, 2020, that it plans to begin its audit of the EPA’s Toxic Substances Control Act (TSCA) Service Fee Fund financial statements for the period from inception, June 22, 2016, to September 30, 2018.  According to the Project Notification, the audit objectives are to determine whether:

  1. The financial statements are fairly presented in all material respects in accordance with generally accepted accounting principles;
  2. EPA’s internal control structure over financial reporting related to the financial statements is in place and provides reasonable assurance that:
    • Financial transactions are executed in compliance with applicable laws, regulations, contracts, and grant agreements;
    • Assets are safeguarded against loss from unauthorized acquisition, use, or disposition; and
    • Transactions are properly recorded, processed, and summarized to permit the preparation of reliable financial statements;
  3. EPA has complied with laws and regulations that would have a direct and material effect on the financial statements; and
  4. The information and manner of presentation contained in the Management’s Discussion and Analysis, and any other accompanying information, are materially consistent with the information contained in the principal statements.

OIG states that the Frank R. Lautenberg Chemical Safety for the 21st Century Act requires that the annual audit of the financial statements also include:

  1. An analysis of the fees collected and amounts disbursed;
  2. The reasonableness of the fees in place as of the date of the audit to meet current and projected costs of administering the provisions of the law; and
  3. The number of requests for a risk evaluation made by manufacturers.

OIG notes that since fees have not been collected, however, it does not anticipate work in this area for the financial statements for the period from inception, June 22, 2016, to September 30, 2018.

 

Try our new TSCA Tutor™ online e-training platform, offering expert, efficient, essential TSCA training.

Tags: Fees, Audit, OIG

 

By Lynn L. Bergeson and Carla N. Hutton

On May 1, 2019, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) sent a memorandum to Alexandria Dapolito Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention, announcing that it “plans to begin preliminary research on the Office of Pollution Prevention and Toxics processes to implement the work to meet statutory deadlines of the Lautenberg Act.”  OIG’s objectives are to determine whether EPA has met the deadlines imposed by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) and whether EPA has the staff, resources, and management controls in place to meet future statutory deadlines.

As reported in our March 6, 2019, memorandum, “GAO Reviews EPA’s IRIS Assessment Efforts and Implementation of TSCA Reforms,” the U.S. Government Accountability Office (GAO) recently assessed whether EPA has demonstrated progress implementing the Toxic Substances Control Act (TSCA) as amended by the Lautenberg Act.  In its report, Chemical Assessments:  Status of EPA’s Efforts to Produce Assessments and Implement the Toxic Substances Control Act, GAO found that while EPA has responded to the initial statutory deadlines in TSCA, as amended by the Lautenberg Act, challenges remain.  As stated in our memorandum, the report draws attention to the challenges facing EPA, including:

  • Pending litigation by environmental groups against many of the final rules;
  • Ensuring appropriate resources and staffing to meet the increased workload required under amended TSCA;
  • Need for development of internal guidance documents to ensure consistency in EPA’s approaches;
  • Ensuring that new chemical review is efficient and predictable, and
  • Attempting to move forward with a major reorganization of the Office of Pollution Prevention and Toxics.

More information is available in our memorandum.


 
 1 2 >