Chemical Assessments: Status of EPA's Efforts to Produce Assessments and Implement the Toxic Substances Control Act

EPA is responsible for reviewing chemicals in commerce and those entering the marketplace. Currently there are more than 40,000 active chemical substances in commerce, with more submitted to EPA for review annually. EPA's IRIS database contains the agency's scientific position on the potential human health effects that may result from exposure to various chemicals in the environment. EPA's IRIS Program, which produces toxicity assessments, has been criticized in the past for timeliness and transparency issues. In response, the IRIS Program committed to making program improvements starting in 2011, which the National Academy of Sciences (NAS) recently commended. TSCA as amended in 2016 provides EPA with additional authority to review both existing and new chemicals and to regulate those that EPA determines pose unreasonable risks to human health or the environment.

This report describes (1) the extent to which the IRIS Program has addressed identified challenges and made progress toward producing chemical assessments; and (2) the extent to which EPA has demonstrated progress implementing TSCA. GAO reviewed NAS and EPA documents and interviewed officials from EPA and representatives from two environmental and two industry stakeholder organizations.

The Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) Program, which prepares human health toxicity assessments of chemicals, has made progress addressing historical timeliness and transparency challenges in the assessment process. Efforts to address timeliness include employing project management principles and specialized software to better plan assessments and utilize staff. To address the need for greater transparency in how the program conducts assessments, IRIS officials and the IRIS Program have implemented systematic review, which provides a structured and transparent process for identifying relevant studies, reviewing their methodological strengths and weaknesses, and integrating these studies as part of a weight of evidence analysis.

Since the process improvements were implemented, the program made progress toward producing chemical assessments through May 2018. In June 2018, the EPA Administrator's office told IRIS officials that they could not release any IRIS-associated documentation without a formal request from EPA program office leadership. In August 2018, according to IRIS officials, program office leadership was asked to reconfirm which ongoing chemical assessments their offices needed. In late October 2018, these offices were asked to limit their chemical requests further, to the top three or four assessments. At the same time—4 months after IRIS assessments were stopped from being released—28 of approximately 30 IRIS staff were directed to support implementation of the Toxic Substances Control Act of 1976 (TSCA), as amended, with 25 to 50 percent of their time, according to officials. Then on December 19, 2018, the Office of Research and Development released its IRIS Program Outlook, which provided an updated list of 13 assessments. Eleven of the 13 chemicals on the IRIS Program Outlook were requested by two EPA program offices. A memorandum issued earlier in December, gave no indication of when additional assessments could be requested or what the IRIS Program's workflow would be in the near term.

EPA has demonstrated progress implementing TSCA, which was amended in June 2016, by responding to statutory deadlines. For example, EPA finalized rules detailing the general processes for prioritizing and evaluating chemicals, known as the Framework Rules, but three of the four rules have been challenged in court. Environmental organizations have argued, among other things, that TSCA requires EPA to consider all conditions of use in prioritizing and evaluating chemicals, rather than excluding, for example, uses that EPA believes are "legacy uses," for which a chemical is no longer marketed. EPA argued that TSCA grants it discretion to determine what constitutes a chemical's conditions of use. Amendments to TSCA in 2016 increased EPA's responsibility for regulating chemicals and in turn, its workload. As such, EPA is required to prioritize and evaluate existing chemicals by various deadlines over an extended period and to make a regulatory determination on all new chemicals. Senior management told GAO that they were confident that ongoing hiring and reorganization would better position the office that implements TSCA.

GAO made recommendations previously to improve the IRIS Program and TSCA implementation. EPA provided comments, which GAO incorporated as appropriate.

The Environmental Protection Agency (EPA) is responsible for reviewing  the environmental and health effects of chemicals in commerce and  chemicals that have yet to enter commerce. Currently more than 40,000  active chemical substances exist in commerce in the United States, with  more new chemicals submitted to EPA for review every year. Since   June 22, 2016, companies have manufactured more than 550 new  chemical substances that EPA approved for commerce. While chemicals  contribute to virtually every aspect of modern life, exposures to chemicals  can have negative health and environmental consequences. EPA’s ability  to effectively implement its mission of protecting public health and the  environment depends on its credible and timely assessments of the risks  posed by chemicals. The agency’s Integrated Risk Information System  (IRIS) Program identifies and characterizes the health hazards of  chemicals and produces chemical assessments that contain this  information. Several program and regional offices at EPA use these  chemical assessments in their statutorily mandated risk management  work.

The Toxic Substances Control Act of 1976 (TSCA) provides EPA with the  authority to review chemicals already in commerce (existing chemicals)  and chemicals yet to enter commerce (new chemicals), obtain more  information on the effects of chemicals on human health and the  environment, and regulate those that EPA determines pose unreasonable  risks to human health or the environment. In 2016, Congress enacted the  Frank R. Lautenberg Chemical Safety for the 21st Century Act  (Lautenberg Act), which amended TSCA to expand EPA’s authority and  responsibility related to regulating toxic chemicals, and established  specific deadlines to promulgate new rules, conduct risk evaluations for  existing chemicals, and review and make determinations for new  chemical submissions, among other responsibilities.

The National Academy of Sciences (NAS) and we have made  recommendations on many topics related to IRIS. As part of EPA’s  response to NAS’s and our recommendations, the IRIS Program began  making changes designed to increase transparency about the program’s  processes and methodologies, increase the use of a systematic review  process, and modernize information collection. In addition, we previously  recommended that EPA develop an agency-wide chemical management  strategy to address the unmet needs of EPA program offices and  regions. In 2009, we also added EPA’s process for assessing and  controlling toxic chemicals to our list of agencies and program areas that  are high risk because of their vulnerabilities to fraud, waste, abuse, and  mismanagement or are in most need of transformation. This area was  added to the High-Risk List as a government program in need of broad- based transformation. While several areas of EPA carry out chemical risk  assessments, this report focuses on the IRIS Program and EPA’s  implementation of TSCA, as amended.

You asked us to examine EPA’s chemical management strategies. This  report describes (1) the extent to which the IRIS Program has addressed  identified challenges and made progress toward producing chemical  assessments and (2) the extent to which EPA has demonstrated  progress, if at all, implementing TSCA, and the key challenges that  remain.

To describe the extent to which the IRIS Program has addressed  identified challenges and made progress toward producing chemical  assessments, we interviewed IRIS officials, including leadership and staff,  and leadership in EPA’s National Center for Environmental Assessment,  which manages the IRIS Program. We also interviewed the leadership (as  of September 2018) in EPA’s Office of Research and Development  (ORD) and officials from EPA program and regional offices that request or  use IRIS assessments on a regular basis. We interviewed representatives  from an environmental stakeholder organization and an industry  stakeholder organization that have both been involved in chemical  regulatory policy and worked with or followed the IRIS Program for the  past several years, including providing comments to the IRIS Program in  response to a Federal Register notice. We identified these individuals  from our prior work with the IRIS Program. In addition, we obtained  program documentation from 2012 through 2019 from IRIS officials and  through our own searches of EPA’s website on changes to IRIS Program  management practices, use of new tools and techniques, and timelines  for the development of chemical assessments. We reviewed applicable  EPA guidelines and program management practices, including the lean  management system being implemented at EPA. We also compared  EPA’s actions to establish priorities with federal standards for internal  control.

To describe the extent to which EPA has demonstrated progress, if at all,  implementing TSCA, and the key challenges that remain, we interviewed  EPA officials in the Office of Chemical Safety and Pollution Prevention  (OCSPP), the EPA office with primary responsibility for implementing  TSCA, including staff in the Office of Pollution and Prevention’s (OPPT)  Chemical Control Division—responsible for risk management—and staff  in the Risk Assessment Division—responsible for risk assessment. In the  Risk Assessment Division, we interviewed five technical teams—working  groups organized by discipline that bring together experts from across  OPPT branches. To gain perspective from outside stakeholder  organizations with interests in EPA’s chemical management strategies, in  addition to the two stakeholder organizations we identified above, we also  interviewed additional representatives from one environmental  stakeholder organization that have followed EPA’s implementation of  TSCA and one industry stakeholder organization that represents  companies affected by changes to TSCA. Our interviews with stakeholder  organizations were designed to collect anecdotal information rather than  findings that could be generalized across all possible stakeholder  organizations. We obtained and reviewed documentation from OCSPP  related to its recent activity responding to TSCA’s requirements and  conducted our own searches of the Federal Register and EPA’s website  to ascertain OCSPP’s progress in responding to deadlines. We also  reviewed documentation on previous and proposed budgets and human  resources associated with OPPT and EPA’s cost estimates for TSCA  implementation.

We conducted this performance audit from March 2018 to March 2019 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.

Risk Assessment and Risk Management at EPA

According to EPA, risk assessments provide information on potential  health or ecological risks. Information from risk assessments, in  combination with other information, provides the basis for risk  management actions, as illustrated in the risk assessment model in figure  1.

EPA may also consider scientific and economic factors; court decisions;  and social, technological, and political factors during the risk management  process.

A number of program and regional offices at EPA prepare chemical risk  assessments. These risk assessments in turn provide the foundation for  EPA’s risk management decisions, such as whether EPA should establish  air and water quality standards to protect the public from exposure to  toxic chemicals. To prepare these risk assessments, some EPA program  and regional offices often rely in part on chemical assessments that the  IRIS Program, as part of ORD, prepares. IRIS assessments generally  include the first two steps of the risk assessment process seen in green in  figure 1: (1) hazard identification and (2) dose-response assessment.  Hazard identification identifies credible health hazards associated with  exposures to a chemical; dose-response assessment characterizes the  quantitative relationship between chemical exposure and each credible  health hazard. The program derives toxicity values through this  quantitative relationship. These toxicity values are combined with  exposure assessments (produced by other offices within EPA) to produce  a risk assessment. OCSPP, which oversees TSCA implementation, also  prepares chemical risk assessments, though it does not generally rely on  IRIS toxicity values. OCSPP’s risk evaluations provide the foundation for  a risk management action under TSCA if a use is found to present  unreasonable risk of injury to human health or the environment. Risk  management actions under TSCA can include but are not limited to  restrictions or bans on a chemical or a condition of use, limitations on  processing or manufacture, or changes to product labeling. Figure 2  shows EPA’s organizational structure, including the program and regional  offices that prepare chemical risk assessments.

EPA created the IRIS Program in 1985 to help develop consensus  opinions within EPA about the health effects from lifetime exposure to  chemicals. The IRIS database of chemical assessments contains EPA’s  scientific positions on the potential human health effects that may result  from exposure to various chemicals in the environment, and as of  November 2018, it included information on 510 chemicals. Based on our  body of work on the IRIS Program, the program’s importance has  increased over time as EPA program offices and regions have  increasingly relied on IRIS chemical assessments in making  environmental protection and risk management decisions. In addition,  state and local environmental programs, as well as some international  regulatory bodies, rely on IRIS chemical assessments in managing their  environmental protection programs. The IRIS Program uses a seven-step  process to produce chemical assessments, as shown in figure 3.

The first step in the assessment development process is developing a  draft assessment. This begins with IRIS Program staff determining the  scope and initial problem formulation of an assessment in consultation  with EPA program and regional offices. This information is documented in  an IRIS Assessment Plan and released for agency and public comment.  After obtaining feedback on the IRIS Assessment Plan, IRIS Program  staff prepare an assessment protocol for public comment that describes  the methods that IRIS will use to conduct the assessment. During Step 1  (Scoping and Problem Formulation) IRIS Program staff conduct  preliminary searches of scientific literature and screen relevant studies to  understand the extent and nature of the available evidence. This informs  the level of effort, identifies areas of scientific complexity, and helps the  IRIS Program estimate time frames for conducting the assessment. The  program staff select and extract relevant data and analyze and integrate  the evidence into the draft assessment. The final step in preparing the  draft assessment is deriving chemical toxicity values. After these draft  development steps (step 1 in fig. 3), the draft assessment goes through  internal agency and interagency review, public comment, and peer  review, as shown in steps 2 through 4 in figure 3. After making revisions  to address comments received (step 5), the assessment goes through  another round of internal and interagency review (steps 6a and 6b), and  then the program finalizes and posts the assessment to the IRIS  website.

According to IRIS officials, in order to prepare IRIS assessments, a group  of staff with specialized skills are required. On any given assessment,  approximately a dozen staff drawn from several different backgrounds  (e.g., toxicologists and epidemiologists) work on each assessment. While  some of the assessment preparation—that is, setting up database  searches and performing initial search screenings—can be performed by  any staff, other parts of assessment development require that the staff  have specific expertise.

The IRIS assessment development process—and the associated  implementation of systematic review processes—has continued to evolve  since 2011, primarily as a result of NAS recommendations made in two  reports issued in 2011 and 2014. The 2011 report was a NAS peer review  of the IRIS assessment of formaldehyde. In that report, NAS  recommended several changes to the formaldehyde assessment and  also offered recommendations more generally about the IRIS assessment  development process. For example, NAS recommended methods for  identifying evidence to be included in IRIS assessments; assessing and  weighting that evidence in preparing the assessment; selecting studies  that are used for calculating toxicity; and documenting how those toxicity  calculations are carried out. A House appropriations committee report for  fiscal year 2015 directed EPA to implement the 2011 report’s  recommendations and NAS to review the changes that EPA was making  (or proposing to make). In its review, NAS made additional  recommendations to the program. In April 2018, NAS released a report  on the IRIS Program’s responses to the 2014 recommendations.

IRIS assessments are one potential source of information for risk  assessors in OCSPP who conduct risk evaluations informing risk  management activities under TSCA. The purpose of risk evaluation is to  determine whether a chemical substance presents an unreasonable risk  to human health or the environment.

EPA’s Evaluation and Management of Chemicals under TSCA

TSCA authorizes EPA to evaluate and, if appropriate, regulate existing  chemicals and new chemicals. TSCA generally covers chemicals  manufactured, imported, processed, distributed in commerce, used, or  disposed of in the United States. If EPA finds that any of these activities  with respect to a specific chemical presents an unreasonable risk of injury  to health or the environment, EPA must issue regulations that can, among  other things, restrict or prohibit these activities.

TSCA also specifies the information obtained from chemical companies  that EPA must publicly disclose and the circumstances under which  chemical companies can claim certain information, such as data about  chemical processes, as confidential business information. EPA’s OPPT  within the Office of Chemical Safety and Pollution Prevention manages  risk assessment and risk management strategies for chemicals under  TSCA. According to EPA officials, OPPT’s Risk Assessment Division uses a number of different streams of information—including IRIS  assessments—to prepare chemical risk assessments in order to make  determinations about the safety of chemicals, and the Chemical Control  Division uses those risk assessments to prepare risk management plans  for chemicals.

Prior to 2016, environmental and industry stakeholder organizations  expressed concern that public confidence was decreasing regarding the  safe use of chemicals in commerce and that federal oversight should be  strengthened. For example, according to an American Bar Association  new TSCA guide, the desire for reform was driven by a proliferation of  state-based chemical initiatives threatening to disturb interstate  commercial transactions and by a continuing erosion of public confidence  in TSCA’s ability to protect human health and the environment from  unreasonable risks presented by chemicals. In addition, according to a  statement from the Environmental Defense Fund, federal oversight could  not keep pace with science or rapidly expanding production and use of  chemicals.

In June 2016, Congress passed the Lautenberg Act, which amended  TSCA in several ways. Table 1 summarizes some of the major changes  in the act, along with the purpose and application of TSCA’s major  sections.

Since passage of the Lautenberg Act, several areas of disagreement  have arisen among stakeholders regarding the implementation of various  aspects of the act. One of the main points of ongoing discussion centers  on what conditions of use EPA must consider in a chemical risk  evaluation under TSCA. EPA and some stakeholders also disagree on  other areas such as the methodologies EPA uses in its systematic review  approach, the extent to which companies’ data are exempt from  disclosure, and the extent to which the fees rule accurately reflects EPA’s  costs for implementing TSCA. Some of these issues have resulted in  litigation.

The IRIS Program Has Made Progress in Addressing Identified Process Challenges, but EPA Leadership Deliberations Delayed Progress on Producing Assessments

The IRIS Program has addressed many process challenges, such as by  making changes to address the length of time it takes to develop  chemical assessments and to increase transparency, but EPA has not  made progress toward producing chemical assessments. However, the  release of documents related to IRIS assessments was delayed for nearly  6 months because EPA leadership instructed the IRIS Program not to  release any assessment documentation pending the outcome of EPA  leadership deliberations concerning IRIS Program priorities.

The IRIS Program Has Made Progress in Addressing Identified Challenges

The IRIS Program in 2011 began making changes to address identified  challenges, particularly the length of time the program took to produce  assessments and the level of transparency in how the program prepared  assessments. The program has made some progress since the beginning  of 2017 toward producing assessments and is ready to release  assessment-related documents. These changes were made in response  to program implementation challenges identified by governmental,  industry, academic, and non-governmental stakeholders in recent years.  For example, in its 2011 report, NAS identified timeliness and  transparency as issues. In our review of the 2011 and 2014 NAS reports  and other documentation as well as our interviews with IRIS officials and  leadership and officials in program and regional offices that use IRIS  assessments, we identified the key actions the IRIS Program has taken to  address lack of timeliness in producing assessments and lack of  transparency in how it produces assessments.

The IRIS Program Has Made Changes to Address Timeliness

Developing IRIS assessments has historically been a lengthy process.  Because of the rigor of the IRIS process and the amount of literature that  program staff must search and consider, producing an assessment  typically takes several years, as we found in December 2011. Program  and regional offices that use IRIS assessments understand this, and  officials from several program and regional offices told us that despite the  length of time it takes for the IRIS Program to complete its assessments,  they prefer these assessments as sources of information over other  agencies’ toxicity assessments.

To address the length of time it takes to produce assessments, the IRIS  Program is (1) employing project management principles and specialized  software that enable the program to better plan assessment schedules  and utilize staff to make the systematic review process more efficient; (2)  focusing on better scoping assessments to create timely, fit-for-purpose  products that address specific agency needs; and (3) streamlining the  peer review process as much as possible.

The Program Has Adopted Project Management Principles and New  Software  The first way in which the IRIS Program is addressing the length of time it  takes to produce assessments is by utilizing project management  principles and new software that enable the program to better plan  assessment schedules and utilize staff. IRIS officials said that by using  these tools, IRIS staff are able to view project tasks, timelines, and  milestones to manage their individual tasks and assessment work. For  example, IRIS officials said that as part of an EPA-wide initiative, they  began incorporating lean management techniques, which aim to improve  efficiency and effectiveness by reducing unnecessary process steps and  waiting time. Additionally, IRIS officials said that they have begun using a  staffing model that trains staff to be proficient in all phases of the  systematic review process (i.e., screening, data extraction, study  evaluation, and evidence synthesis). This modularity will make it easier  for staff to work across teams and on multiple projects, assisting with  systematic review needs while also contributing in their areas of  expertise, according to IRIS Program officials. In addition, the IRIS  Program began using both project management software and business  intelligence and visualization software in 2017. IRIS Program leadership  is using this software to generate resource allocation reports showing  staff assignments, enabling leadership to better manage staff workloads.

According to IRIS officials, the recent adoption of specialized systematic  review software also enables program staff to perform more literature  searches faster, and the ability to filter search results allows staff to find  more quickly the most relevant information for an assessment. Use of  software tools with machine-learning capabilities facilitate program staff’s  ability to screen studies for relevance more quickly compared to  approaches used before 2017. Prior to the adoption of these specialized  software tools, much of the development of an assessment was manual  (i.e., using a spreadsheet). For example, for one assessment developed  manually, contactors working on an IRIS assessment took over 200 hours  to screen and catalog 1,200 epidemiological studies, including carrying  out quality assurance checks. By comparison, using machine-learning  tools, EPA staff were able to screen almost 5,500 articles in about 30  hours. With the new tools, quality assurance was embedded into the  workflow by having two independent reviewers and a software-facilitated  process track and resolve screening conflicts.

Additionally, an official from EPA’s National Health and Environmental  Effects Research Laboratory said that the laboratory uses a similar  screening process. The laboratory worked with the IRIS Program to  identify similar constructs in their processes and used each other’s results  to make changes and validate tools used by both. According to IRIS  officials, as a result, the use of these tools has created more efficient  workflow processes, leading to considerable cost and time savings. The  incorporation of systematic review software tools has greatly helped the  program more efficiently carry out tasks like screening literature,  evaluating study quality, extracting data, and developing visualizations,  according to IRIS Program officials we interviewed. Most importantly, the  software tools allow multiple staff members to work on tasks  simultaneously, rather than one at a time, facilitating concurrent  completion of key assessment pieces.

The Program Tailors Assessments to Program and Regional Office  Needs  The second way in which the IRIS Program is reducing the length of time  it takes to produce assessments is by tailoring them to program and  regional office needs, called fit-for-purpose assessments. According to  IRIS officials, part of the reason assessments historically were time- consuming was because the program tried to synthesize and present all  possible information on the human health effects of a particular chemical,  including multiple exposure pathways (e.g., inhalation, ingestion, or  dermal) and reference doses, reference concentrations, and cancerous  and non-cancerous effects. This required large amounts of data  extraction and was very time intensive. Beginning in early 2017, the  program began implementing the fit-for-purpose approach to producing  assessments. IRIS officials said the idea is that instead of producing a  wide-ranging assessment, the program can produce assessments that  are more limited in scope and targeted to specific program and regional  office needs, reducing the amount of time IRIS staff needed to search for  information, synthesize it and draft, review, and issue an assessment. For  example, if the Office of Air and Radiation needed a chemical  assessment that examined only inhalation exposures, the IRIS Program  could limit its assessment to a single exposure pathway, which would  reduce the amount of data that staff review and extract and, with less text  to draft and less complex peer reviews, allow the assessment to more  quickly move through the process.

IRIS officials said that if offices make subsequent requests for other  effects or exposure pathways, the IRIS Program can update the original  assessment. IRIS officials said that they expect time savings as a result  of moving to the fit-for-purpose model. As of November 1, 2018, the IRIS  Program had produced two fit-for-purpose assessments: a request for  correction on chloroprene and an update of the assessment on acrolein.  An assessment on perfluorobutane sulfonic acid (PFBS) was also  released for public comment following peer review. PFBS are a member  of a class of man-made chemicals known as per- and polyfluoroalkyl  substances (PFAS)—a groups that also includes perfluorooctane  sulfonate acid (PFOS), perfluorooctanoic acid (PFOA), GenX, and many  others. In addition, since 2017, the IRIS Program released scoping and  problem formulation materials for six IRIS chemical assessments  (nitrates/nitrites, chloroform, ethylbenzene, uranium, ammonia, and  naphthalene).

Additionally, the program is examining ways to assist program and  regional offices with information that may not necessitate developing a full  assessment. For example, the Office of Air and Radiation was doing work  using a toxicity value for acrolein that the California Environmental  Protection Agency prepared in 2008, because that value was more recent  than the value in the IRIS database. However, a large number of studies  on acrolein had been released since 2008, so the IRIS Program searched  approximately 10,000 new studies and concluded that the study used by  California Environmental Protection Agency in 2008 was still the most  appropriate study for chronic toxicity value derivation. In addition, IRIS  staff developed an updated draft reference concentration for acrolein  based on this study. The screening and update process took  approximately 4 months, demonstrating how the IRIS Program’s use of  new tools and a targeted scope resulted in more timely attention to  program office needs.

The Program Is Streamlining the Peer Review Process  The third way the IRIS Program is addressing the length of time it takes to  produce assessments is by streamlining the peer review process as much  as possible without compromising the quality of the review. EPA  guidelines require peer review of all IRIS assessments. Smaller, less  complex assessments may be peer reviewed through a contractor-led  letter review or panel; more complex assessments are usually reviewed  by a full Scientific Advisory Board (SAB) or a NAS panel, though IRIS  leadership determines the most appropriate method of peer review based  on Office of Management and Budget and EPA Peer Review Handbook  guidelines. While the contractor-led letter or panel reviews are no less  robust than full SAB or NAS panel reviews, the contractor-led reviews are  usually smaller and completed in less time because they are reviewing  smaller, less complex IRIS assessments. The time savings occur  because the reviewers do not typically meet in person, or may meet only once, typically taking a few months to complete their reviews. In contrast,  SAB and NAS panels involve larger numbers of people who meet multiple  times, review longer and more complex assessments, and must reach  consensus on their reviews. As a result, SAB and NAS peer reviews can  take more than a year to complete. IRIS officials said that as they try to  produce more fit-for-purpose assessments that are smaller in scope, they  plan to utilize letter reviews as appropriate, to streamline the peer review  process. IRIS Program officials said they also hope that other changes  they recently implemented—primarily, increased transparency and  systematic review—will help speed up the peer review process by  producing a higher-quality overall draft.

The IRIS Program Has Made Changes to Address Lack of Transparency

Another major category of NAS recommendations that the IRIS Program  has addressed is the need for greater transparency in how the program  conducts assessments. For example, one industry representative  expressed concern in August 2018 about transparency before the  program began making changes, describing the IRIS Program as a “black  box” because “no one knew how the program created its methodologies,  weighted evidence, or produced assessments.” In response, the IRIS  Program has in the past several years (1) implemented systematic  review, which provides a structured and transparent process for  identifying relevant studies, reviewing their methodological strengths and  weaknesses, and integrating these studies as part of a weight of evidence  analysis, and (2) increased outreach efforts with stakeholders and the  public, both in terms of the frequency and the depth of content about  assessment preparation.

The Program Began Implementing Systematic Review as a Basis of  Its Assessments  The IRIS Program began addressing the need for greater transparency  by implementing systematic review as a basis for every assessment and  has been doing so for several years. A systematic review is a structured  and documented process for transparent literature review. It is a scientific  investigation that focuses on a specific question and uses explicit,  prespecified scientific methods to identify, select, assess, and summarize  the findings of similar but separate studies. The goal of systematic review  methods is to ensure that the review is complete, unbiased, reproducible,  and transparent. By using systematic review, the IRIS Program can  demonstrate that it considered all available literature in forming  conclusions and deriving toxicity values. Utilizing the new software tools  described above allows program staff to search more widely than before  and to identify the most relevant results faster and more accurately. The  IRIS Program is working with technical experts to increase the  applications of machine learning for carrying out systematic review.

Additionally, new software allows the IRIS Program to save and publish  its search strings and to indicate why it selected certain studies over  others for review and inclusion. The software also allows multiple staff to  check searches and concur or not-concur with the initial assessment  about including a scientific article in the draft assessment. IRIS officials  told us that the transparency associated with systematic review and  clearer explanation of methodologies in assessments (as well as  releasing subsidiary documents, such as IRIS Assessment Plans and  Assessment Protocols) will improve stakeholders’ understanding of how  the program arrives at its conclusions.

The Program Has Made Changes to Communication Frequency and  Type  The IRIS Program also furthered transparency by increasing the  frequency, structure, and content of communications with EPA program  and regional offices about overall program priorities and individual  assessments. This allows EPA program and regional offices to know  when to expect assessments, as well as what those assessments will  cover. To prepare the 2015 Multi-Year Agenda, the IRIS Program  solicited requests from EPA program and regional offices about which  chemical assessments they needed; these requests were released in  December 2015. When new leadership joined the IRIS Program in early  2017, the new officials began reaching out to individual program and  regional offices to re-confirm their needs and priorities. IRIS officials said  this effort was in part to ensure that the IRIS Program was delivering what  the program offices needed, as well as to help the IRIS Program keep its  priorities up to date and ensure that resources (primarily staff) were  aligned with EPA-wide priorities. Based on these conversations with  program and regional office staff, the IRIS Program made some chemical  assessments higher priority and removed others from the program’s  workflow, consistent with stated needs.

In May 2018, the IRIS Program prepared a statement for posting on the  IRIS website outlining these changes to the program’s workflow and an  updated list of assessments that were being developed with anticipated  completion time frames. However, EPA leadership in ORD—the office  that oversees the IRIS Program—did not approve this statement for  release because current EPA leadership in program and regional offices  had not formally requested these assessments. Nevertheless, officials  from program and regional offices that use IRIS assessments told us that  they received clear communication from the IRIS Program about priorities  and timelines for individual assessments. According to these officials,  some of this communication took place when IRIS Program leadership  reached out to program and regional office officials to confirm their needs,  and some took place during monthly telephone calls the IRIS Program  held to update stakeholders on assessment development timelines.  Program and regional office officials told us that they appreciated the IRIS  Program’s recent efforts to understand program and regional office needs  and timelines; communicate the status of assessments more frequently;  and find ways to assist program offices that may not require developing a  full assessment, such as assessment updates or literature reviews.

Since 2013, the IRIS Program has released preliminary assessment  materials—including IRIS Assessment Plans and assessment protocols— so that EPA and interagency stakeholders and the public could be aware  of scoping and problem formulation for each assessment. Since 2017,  according to EPA, these documents had a new structure and better  demonstrate the application of systematic review, and they continue to  convey EPA’s need for each assessment and frame questions specific to  each assessment. Officials in several program and regional offices that  use IRIS assessments told us that the release of IRIS Assessment Plans  and protocols was very helpful because it allowed them to offer early  input to the IRIS Program about the scope of an assessment, when it  could affect the direction of the assessment. IRIS officials also said that  they created templates for several parts of the assessment process,  including the IRIS Assessment Plans and assessment protocols, which  help maintain consistency throughout assessment development and from  one assessment to the next.

The Program Made Progress in Early 2018 on Assessments in Development

During calendar year 2018, the IRIS Program planned to release  documents or hold meetings for 15 of the 23 ongoing chemical  assessments in development, as well as for the IRIS Handbook and a  template for assessment protocols. From January through May 2018, the  IRIS Program met each of its internal deadlines for work on 9 different  chemical assessments and released the template for assessment  protocols for agency review. The IRIS Program also produced a report to  Congress on the program’s work in January 2018 and took part in a NAS  review of the program in February 2018. The NAS review, which offered a  third-party assessment of the program’s efforts, provided a supportive  assessment of ongoing transformations aimed at ensuring data quality,  new systematic approaches for data analysis and expanded stakeholder  engagement efforts, and increased the efficiency of assessments.  According to the report, NAS reviewers were impressed with the changes  being instituted in the IRIS Program since 2014, including substantive  reforms by new IRIS Program leadership, such as the development,  implementation, and use of systematic review methods to conduct IRIS  assessments. In addition, as of August 2018, the final IRIS assessment of  hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) was issued. In early  November 2018, IRIS officials told us that the agency had almost  completed internal review of the handbook, which was being prepared for  public release. In December 2018, the IRIS Program and OPPT  participated in a NAS workshop that informed the systematic review of  mechanistic evidence.

Budget Cuts May Impact the Program’s Ability to Expand Assessment Development

The IRIS Program has made important changes aimed at producing more  timely and transparent assessments, but IRIS officials told us that  proposed budget cuts have caused them concern about whether they will  have sufficient resources to expand assessment work in the future. The  human health risk assessment area, of which IRIS’s budget makes up  approximately half, has been funded at about $38 million annually since  fiscal year 2013 based on our review of EPA budget documents.  However, the President’s budget request for human health risk  assessment work in fiscal years 2018 and 2019 was $22.5 million and  $22.2 million, respectively. This represents a cut of approximately $17  million from previous budget levels dating back to fiscal year 2013. The  IRIS Program budget would drop approximately 40 percent from $20.8  million to approximately $12 million if these cuts were enacted. Congress  did not support these reductions. Specifically, according to the joint  explanatory statements accompanying the Consolidated Appropriations  Act, 2018, and Consolidated Appropriations Act, 2019, Congress had  agreed to continue providing funding at fiscal year 2017 enacted levels.  Cuts to the program could impact EPA’s regulatory work: Officials in almost all of the program and regional offices that use IRIS assessments  told us that they rely on IRIS assessments to do their work—it is the first  place they look for chemical toxicity values, and if the IRIS Program is  unable to produce assessments, their offices would be challenged to  meet statutory deadlines and there would be a generally negative effect  on public health.

IRIS Program Progress toward Producing Assessments Was Delayed by EPA Leadership Deliberations about Priorities

The IRIS Program made progress developing assessments and  producing assessment documentation (e.g., IRIS Assessment Plans and  protocols) in early 2018. However, EPA leadership deliberations about  the program’s priorities that took place from June through December  2018 delayed the program’s assessment production.

IRIS officials told us that in early June 2018 EPA leadership in ORD  informed them that the IRIS Program could not release an assessment  without a formal request for that assessment from the current leadership  of a program office. At the request of the Administrator, IRIS officials  prepared a survey of program and regional offices, asking them to re- confirm their needs for 20 assessments that were in development. This  survey was sent by memorandum in August 2018. Program office  responses were to be signed by the Assistant Administrator of each  program office to ensure that the re-confirmations were consistent with  the priorities of EPA program office leadership. While survey responses  were being compiled, EPA leadership in ORD instructed the IRIS  Program not to publically release any assessment documentation. As a  result, any assessment or subsidiary assessment document (e.g., an IRIS  Assessment Plan or protocol) that was ready for agency review, public  comment, or peer review was unable to proceed through the IRIS  assessment development process.

In late October 2018, prior to releasing results of the initial program and  regional office survey, EPA leadership in ORD made a second request of  program offices for a prioritized list of assessments. According to officials  from the IRIS office, who were queried for advice by officials from some  program offices, ORD’s second request was made verbally at a meeting  and included direction to the program offices to limit their requests to no  more than three to four chemicals. ORD’s request did not provide  information on the basis for selecting priorities or the reason for the limit  of three or four chemical assessments from the original survey  submissions. The calls for advice from program office officials  represented the first time the IRIS Program heard about the requests for  a prioritized list, according to IRIS program officials. And since neither the  program and regional offices nor the IRIS Program had information from  the Administrator’s office about what the prioritization was meant to  achieve, the IRIS Program was unable to provide guidance about what  chemicals might be considered a priority, or how many they might be able  to continue work on.

When EPA leadership’s deliberations about the program’s priorities were  completed, a memorandum was issued on December 4, 2018, that listed  11 chemical assessments that the IRIS Program would develop. This was  a reduction of the program’s workflow from 22 assessments, but the  memorandum announcing the reduced workflow gave no reason for the  reduction. The memorandum accompanying the list of 11 chemicals gave  no indication of when more assessments could be requested or if IRIS’s  workflow would remain at 11 chemicals for the foreseeable future.  According to the memorandum, the 11 chemicals were requested by two  EPA program offices (the Office of Water and the Office of Land and  Emergency Management). We received this memorandum at the end of  our review and did not have the opportunity to review the prioritization  process that led to its drafting.

Two weeks after the issuance of the memorandum, the IRIS program  publicly issued an outlook of program activities, which included two  additional assessments that were not included in the memorandum.  These two assessments, ethyl tertiary butyl ether (ETBE) and tert-butyl  alcohol (TBA), were not included in the memorandum because they were  out for public comment and external peer review. Furthermore, four  assessments that were in the later stages of development and had not  been issued were not included in the December 2018 Outlook. The four  assessments were: acrylonitrile, n-Butyl alcohol, formaldehyde, and  polycyclic aromatic hydrocarbon (PAH). The assessment of formaldehyde  was, according to the “IRIS Assessments in Development” website, at  Step 4 of the IRIS process (an assessment is drafted and was ready to be  released for public comment and external peer review). The absence of  these four assessments from the December 2018 Outlook could create  confusion for stakeholders interested in them. EPA provided no  information on the status of these four assessments or whether it planned  to discontinue working on them or restart them at another time. As we  have previously reported, an overarching factor that affects EPA’s ability  to complete IRIS assessments in a timely manner is that once a delay in  the assessment process occurs, work that has been completed can  become outdated, necessitating rework throughout some or all of the  assessment process. Thus, it remains to be seen when these  assessments can be expected to move to the next step in the IRIS  process or be completed.

As of December 19, 2018, the status of the 13 assessments in the  December 2018 Outlook was:

Draft Development: arsenic, inorganic; chromium VI; polychlorinated  biphenyls (PCBs; noncancer); perfluorononanoic acid (PFNA);  perfluorobutanoic acid (PFBA); perfluorohexanoic acid (PFHxA);  perfluorohexane sulfonate (PFHxS); and perfluorodecanoic acid  (PFDA).

Scoping and Problem Formulation: mercury salts; methylmercury;  vanadium and compounds.

According to IRIS officials, the IRIS Program was unable to release any  work since June 2018, while it was waiting for feedback from the  Administrator’s office regarding whether its assessment workflow was  consistent with agency priorities. IRIS officials told us that staff continued  whatever draft development work that they could do internally, but several  IRIS staff have been working increasingly for OPPT to support its work  preparing risk evaluations under TSCA. ORD reported to us that in  September 2018—3 months after IRIS assessments were stopped from  being released because of ongoing EPA leadership deliberations—5 of  approximately 30 IRIS staff were supporting OPPT with 25 to 50 percent  of their time. In October 2018—4 months after IRIS assessments were  stopped from being released—28 of approximately 30 IRIS staff were  supporting OPPT with 25 to 50 percent of their time. According to IRIS  officials, this was occurring primarily because OPPT has a significant  amount of work to do to meet its statutory deadlines, and OPPT needed  IRIS staff expertise to help meet those deadlines. As noted above, TSCA  establishes a regulatory standard that generally differs from those under  other environmental laws, so the TSCA assessments will not necessarily  be relevant to other EPA programs that have relied on IRIS endpoint  values in making their regulatory decisions.

EPA Has Demonstrated Progress Implementing TSCA by Responding to TSCA Statutory Deadlines through the End of Fiscal Year 2018, but Key Challenges Remain

EPA has demonstrated progress implementing TSCA by responding to  TSCA’s statutory deadlines through the end of fiscal year 2018, including  promulgating rules, developing guidance, and releasing reports.  However, EPA faces key challenges to its ability to implement TSCA,  such as managing the risks posed by ongoing litigation, ensuring  appropriate resources, developing guidance to ensure consistency, and  ensuring that the new chemicals review process is efficient and  predictable.

EPA Responded to TSCA Statutory Deadlines

EPA has responded to initial statutory deadlines under TSCA, as  amended by the Lautenberg Act, including requirements to promulgate  new rules, develop guidance, and release reports. For example, EPA began 10 risk evaluations drawn from the 2014 update of the TSCA  Work Plan within 180 days of enactment of the Lautenberg Act   (§ 6(b)(2)(A));  submitted an initial report to Congress estimating capacity for and  resources needed to complete required risk evaluations within 6  months of enactment (§ 26(m)(1));  carried out and published in the Federal Register an inventory of  mercury supply, use, and trade in the United States by April 1, 2017.  (§ 8(b)(10)(B)); developed guidance to assist interested persons in developing and  submitting draft risk evaluations within 1 year of enactment   (§ 26(l)(5)); and developed a plan for using alternative test methods to reduce use of  vertebrate animal testing within 2 years of enactment (§ 4(h)(2)(A)).

In addition, in four areas in which Congress required EPA to establish  processes and structures for TSCA, EPA finalized four rules detailing the  general processes for prioritizing and evaluating chemicals under TSCA,  known together as the Framework Rules. EPA responded to the 1-year  deadlines to establish three of the four Framework Rules. These three  rules are  the risk prioritization rule, which explains EPA’s process for  prioritizing existing chemicals for risk evaluation;  the risk evaluation process rule, which explains EPA’s process for  conducting risk evaluations on existing chemicals; and  the inventory notification rule, which requires manufacturers and  processors of chemical substances to report which chemicals are  currently in commerce.

The fourth Framework Rule EPA issued, which had no issuance deadline,  implements a Lautenberg Act provision authorizing EPA to collect fees for  carrying out a number of different activities under TSCA, including  collecting fees from manufacturers and processors that submit new  chemicals or submit chemicals for significant new uses to EPA for review.

Though EPA responded to all of the statutory deadlines, some  environmental and industry stakeholder organizations we interviewed told  us that they do not believe this is a complete measure of how well EPA is  implementing TSCA. Representatives from one environmental  stakeholder organization told us in July 2018 that it is still too early to  assess how well EPA is implementing TSCA because none of the existing  chemical risk evaluations ongoing under the new process have been  released; the wording in the new rules and documentation is unclear; and  the risk prioritization rule, the risk evaluation rule, and the inventory reset  rule have been challenged in court. However, in January 2019 they told  us that they were too optimistic in their assessment of TSCA  implementation and believe EPA is falling behind in its progress. As of  December 2018, representatives from another environmental stakeholder  group told us that, while EPA has met a number of major statutory  deadlines, the agency’s rules and other actions do not reflect the best  available science and are contrary to both the letter and intent of the new  TSCA Act. However, in January 2019 an industry stakeholder  organization noted that the 2016 amendments to TSCA are generally  being implemented effectively and efficiently as Congress envisioned,  and the agency continues to meet important deadlines required by the  law. In addition, they also told us that EPA’s TSCA program is also  utilizing the best available science and a weight of the evidence approach  to make high quality chemical management decisions. Representatives  from industry stakeholder organizations we interviewed told us they  believe the rules are consistent with TSCA, but that EPA is not  consistently meeting the 90-day deadline to make determinations on new  chemicals or the 30-day deadline to make determinations on low-volume  exemptions.

EPA faces challenges with its ability to implement TSCA, such as  managing the risk posed by ongoing litigation, ensuring appropriate  resources, developing guidance documents to ensure consistency, and  ensuring that the new chemicals review process is efficient and  predictable.

Three of the four Framework Rules that EPA issued to implement TSCA  have been challenged in court: the risk prioritization rule, the risk  evaluation rule, and the inventory notification rule.

Procedures for Prioritization of Chemicals for Risk Evaluation  under the Toxic Substance Control Act (risk prioritization rule). In  Safer Chemicals, Healthy Families v. U.S. Environmental Protection  Agency, a collection of environmental and public health organizations  challenged several aspects of EPA’s TSCA implementation, including  the risk prioritization rule. Specifically, the environmental  organizations argue, among other things, that the plain language of  TSCA requires EPA to consider all conditions of use in prioritizing  chemicals for review under TSCA, rather than excluding, for example,  uses that EPA believes are “legacy uses” for which a chemical is no  longer marketed. EPA and chemical industry intervenors respond by  arguing that TSCA grants EPA discretion to determine what  conditions constitute a chemical’s conditions of use and to generally  exclude legacy activities—primarily historical activities that do not  involve ongoing or prospective manufacturing, processing, or  distribution in commerce of a chemical substance as a product.

Procedures for Chemical Risk Evaluation under the Amended  Toxic Substances Control Act (risk evaluation rule). In Safer  Chemicals, Healthy Families v. U.S. Environmental Protection  Agency, the environmental organizations also contend that EPA’s risk  evaluation rule is contrary to TSCA, in part because, as noted above,  the rule “impermissibly” excludes uses that the law requires EPA to  include in its risk evaluations. EPA and industry intervenors  responded by arguing that TSCA grants EPA discretion to determine  what conditions constitute a chemical’s conditions of use. The  organizations also argued that the risk evaluation rule would deter  public participation in the risk evaluation process by imposing criminal  penalties on a member of the public who submits incomplete  information to EPA but does not impose similar penalties on  manufacturers. In August 2018, the government moved to vacate  the penalty regulation, and the environmental organizations  consented to this motion.

Inactive) Requirements (inventory notification rule). In  Environmental Defense Fund v. U.S. Environmental Protection  Agency, an environmental organization challenged EPA’s inventory  notification rule, which EPA issued in response to a TSCA  requirement that EPA identify which chemicals in the TSCA inventory  are still in use and require substantiation of claims that chemical  identities constitute confidential business information that can be  withheld from public disclosure. The environmental organization  argued, among other things, that the rule impermissibly allows any  persons to assert confidentiality claims for any chemical they  manufacture or process, rather than just the original claimant. EPA  and industry intervenors responded in part by arguing that TSCA  specifically allows any affected manufacturers to maintain an existing  confidentiality claim for a specific chemical identity, which the industry  intervenors assert constitutes critically important intellectual property.

OPPT officials told us they are trying to not anticipate the results of the  litigation and, instead, address the outcome of each case as it is decided.  They stated that they are staying aware of developments in ongoing  litigation and are constantly considering potential outcomes but believe it  would not be reasonable to prepare explicit resource plans for unknown  future scenarios. If EPA loses any of these lawsuits, it may need to  devote additional resources to implement the relevant provisions of  TSCA. For example, if the suit involving the risk evaluation rule is  successful, EPA may be forced to redo parts of its risk evaluations close  to the December 2019 deadline to finalize these evaluations. EPA is  required to complete its first 10 existing chemical evaluations not later  than 3 years after the date on which it initiated the risk evaluations, which  was December 2016. TSCA also allows for an extension of the risk  evaluation deadlines for up to 6 months if the agency deems it necessary.

EPA Faces Challenges Ensuring That It Has Appropriate Resources

The Lautenberg Act greatly increased OPPT’s workload. Prior to the  enactment of the Lautenberg Act, EPA did not have deadlines for  completing existing chemical evaluations. Under the Lautenberg Act, EPA  must finalize 10 ongoing risk evaluations by December 2019, which  represents a tight deadline, according to EPA officials. Furthermore, the  law requires EPA to ensure that 20 risk evaluations are ongoing for high- priority substances 3-1/2 years after enactment and that at least 20  chemical substances have been designated as low-priority substances.  In addition, under TSCA prior to the Lautenberg Act, a new chemical  could enter commerce after 90 days unless EPA took action to the  contrary. Under the Lautenberg Act, EPA is required to make a  determination on a new chemical before it can be manufactured—another  source of increased workload.

Partially because of the increased workload, some OPPT officials told us  that they have concerns about staff capacity within OPPT. Officials in  both the Chemical Control Division (responsible for risk management)  and the Risk Assessment Division (responsible for risk assessment) said  that they do not have sufficient resources to do their work. This included  staff from all five technical teams we interviewed in the Risk Assessment  Division. Technical teams are working groups organized by discipline that  bring together experts from across OPPT branches. The Risk  Assessment Division is particularly affected by the heavy workload,  according to OPPT officials and representatives from an industry  stakeholder organization. The division must review all of the  premanufacture notices for new chemicals and contribute to the first 10  existing chemical evaluations. Officials from the Chemical Control  Division told us that the Risk Assessment Division is struggling more  because its work requires more technical employees. The officials said  that EPA is hiring additional full-time equivalents (FTE), but it takes time  to train new people, and this will initially increase workload. Officials told  us that in July 2018, OPPT had about 300 FTEs and was authorized to  hire 40 additional FTEs. As of October 2018, OPPT officials told us that  they had hired or extended offers to 20 to 25 of that 40 and continued to  hire more employees. OPPT officials told us that reaching an appropriate  level of FTEs—including recruiting and retaining staff—is challenging.  OPPT officials said they expect that the recently announced initiative to  implement direct hiring authority for scientific and technical positions will  have a positive impact on these efforts.

To address the staffing challenge, staff have also been reassigned from  other parts of EPA to OPPT. For example, staff in the Safer Choice  Program—an EPA program that helps consumers, businesses, and  purchasers find products that perform and are safer for human health and  the environment—were redeployed to the Chemical Control and the Risk  Assessment Divisions. Representatives from both industry stakeholder  organizations we interviewed told us that it can be difficult to work with  recently reassigned staff who are not familiar with the chemicals they are  working on. Representatives from an industry stakeholder organization  told us that, in some cases, OPPT staff are ill-prepared to make decisions  about a premanufacture notice. OPPT senior officials said there is always  a learning curve for reassigned employees, but they do not put new  people in positions to make decisions on premanufacture notices. They  said that these decisions are never made by one person in a vacuum.

OPPT officials and staff told us that they are generally optimistic about an  upcoming reorganization of OPPT that will separate assessment and  management of new and existing chemicals programs and better align  the structure of OPPT with the focus of TSCA’s provisions. For example,  the Chemical Control Division and the Risk Assessment Division currently  each handle both new and existing chemicals, and the planned  reorganization will divide the divisions into new and existing chemical  divisions. However, staff told us that they have concerns about whether  the new divisions will be adequately staffed, the timing of the  reorganization, and their future placements.

Staff from multiple technical teams we interviewed in the Risk  Assessment Division said that they are not sure if, after the  reorganization, the new divisions will be adequately staffed. Staff from  one technical team said there has been increased attrition in recent  years, partially because of concerns about the upcoming reorganization.  Staff from another technical team said that a large number of  management positions are unfilled. Staff from multiple technical teams  told us that it will take time after the reorganization to redistribute work  and train staff. Staff from one team said the reorganization is ill-timed  because there are currently too many other ongoing high-priority projects.  Staff from multiple technical teams also told us that they are experiencing  anxiety about their future placements and with whom they will work. In  commenting on a draft of this report, EPA stated that the concerns raised  by staff are likely common to any program undergoing change. OPPT  officials said they submitted the reorganization proposal to EPA’s Office  of Mission Support—formerly the Office of Administration and Resources  Management—in October 2018 and that it could take several more  months as EPA management works out details with labor unions and  addresses other issues. Officials said that they anticipate implementing  the reorganization in early 2019.

OPPT senior officials said that now that OPPT has many new  responsibilities and a heavier workload, they are taking steps to improve  capacity by implementing the reorganization and hiring new staff. The  officials said that though there will inevitably be growing pains, the  changes are part of a larger plan specifically designed to better position  OPPT to implement TSCA. Senior officials also told us that they have  spent considerable time setting expectations for new and existing staff.

In tandem with the major changes that increased EPA’s workload, the  2016 amendments to TSCA authorize EPA to establish fees to defray a  portion of the costs of administering TSCA sections 4, 5, and 6 and  collecting, processing, reviewing, providing access to, and protecting  information about chemical substances from disclosure, as appropriate,  under TSCA section 14. Affected businesses began incurring fees  under the new rule as of October 1, 2018, but it is unclear whether the  fees collected will be sufficient to support relevant parts of the program.  OPPT officials told us that while they are uncertain how much the fees  rule will generate the first year, they believe that over the course of a few  years, the amount of money generated should stabilize. The first year is  where officials are not sure how much they may receive. Officials expect  to collect an average of $20 million per year over the next 3 fiscal years.  In fiscal year 2019, however, they expect to collect approximately $7  million to $8 million. According to EPA, the agency will be tracking its  costs and use that information to adjust future fees, if appropriate. As  required by law, EPA will evaluate and readjust, if necessary, the fees  every 3 years.

EPA estimates the average yearly cost of TSCA implementation for fiscal  years 2019 through 2021 to be $80,178,000. EPA’s fiscal year 2019  budget justification shows $57,973,700 allocated to TSCA  implementation. However, EPA does not expect a budget shortfall in  fiscal year 2019 because, according to officials, they (1) have funds  available from 2018 to support fiscal year 2019 needs, (2) receive support  from other EPA offices like the Office of General Counsel and the Office  of Research and Development, (3) expect fiscal year 2019 costs to be  lower than the 3-year average described in the fees rule, and (4) expect  some indirect costs to be covered by non-TSCA budget categories.

EPA Faces Challenges Developing Guidance to Ensure Consistency

EPA also faces challenges in developing guidance to ensure consistency  in implementing the law. OPPT officials said that, given the tight timelines  that TSCA requires, they have not yet created all the necessary guidance  for staff implementing the law. Officials likened it to building an airplane  as they fly it, as they must create guidance and processes, while  simultaneously applying them to chemical evaluations. Staff from four of  five technical teams we interviewed are either currently updating their  guidance, still developing their guidance, or have never developed  guidance before. Staff from two teams told us that they are developing  the guidance as they apply it to their work. OPPT officials told us that they  are using some guidance that was in place before the Lautenberg Act  was enacted, though they are working on updates.

Representatives we interviewed from industry stakeholder organizations  said they want EPA to be clear about its standards for the new chemicals  program and how they are defining terms in TSCA. Representatives from  one industry stakeholder organization suggested that EPA should  establish some definitions and develop guidance on how to apply those  definitions, in order to help both chemical manufacturers and reviewers  within OPPT. In June 2018, EPA released “Points to Consider When  Preparing TSCA New Chemical Notifications,” guidance that  representatives from industry stakeholder organizations said is helpful,  but they are still not sure how EPA is using information like the Points to  Consider guidance in its evaluations and against what standard EPA’s  reviewers are reviewing and assessing a chemical. Representatives we  interviewed from industry stakeholder organizations said that decisions on  new chemical reviews depend on individual reviewers because EPA has  not provided the reviewers with guidance that ensures consistency.  OPPT officials also said consistency is a challenge in conducting risk  assessments. Representatives we interviewed from environmental  stakeholder organizations did not mention consistency as an area of  challenge.

EPA Faces Challenges Ensuring That the New Chemicals Review Process Is Efficient and Predictable

Representatives from both industry stakeholder organization we  interviewed also told us that the new chemicals program is too slow and  unpredictable, which can negatively affect innovation. For example,  representatives from one company told us in comments they provided  through an industry stakeholder organization we interviewed that it  submitted a premanufacture notice for a substance that would decrease  the potential for worker and environmental exposure while providing  improved product performance. The approval process extended to nearly  550 days compared to the 90 days it typically took to obtain approval prior  to TSCA’s amendment. EPA can request extensions, and submitters can  voluntarily suspend the review process; therefore, the overall process can  extend beyond the 90-day requirement. For example, in the new chemical  review process, EPA first makes an initial determination. If a company  does not like this initial determination, it can request more time to provide  additional data or develop new data in an effort to get a positive final  determination. A company withdraws its submission prior to a final EPA  determination if it is clear the determination will not be favorable and the  chemical will be regulated. EPA officials said the agency does not  violate the mandated timelines because submitters agree to voluntarily  suspend the review process. However, representatives from one industry  stakeholder organization told us that as of December 2018, with the  passage of time and greater familiarity with Lautenberg, OPPT’s decision  making process has improved and is more predictable.

EPA officials said that historically, even among new chemicals for which  EPA completed review, 57 percent actually entered commerce. Officials  said that in the past companies submitted new chemicals just to see what  determinations EPA would make. Going forward, as of October 2018,  officials said they expect larger fees will result in some companies  choosing to be more selective in the chemicals they submit to the  program. In addition, EPA officials told us that after OPPT’s  reorganization, a more devoted team will focus on pre-notice meetings  with companies. Officials said this should reduce some of the back and  forth with submitters, thereby improving timelines.

Representatives we interviewed from industry stakeholder organizations  also told us that delays motivate companies to introduce chemicals first in  foreign markets. For example, one company told us through comments it  provided through an industry stakeholder organization we interviewed that  it developed a new technology in the United States, but because of the  lengthy delays experienced with new chemicals reviewed under TSCA,  they will neither register nor commercialize the product in the United  States at this time. Rather, the company has decided to pursue  commercialization in Europe, which will enable the company to deliver the  benefits of this new technology to their customers in the European market  sooner than is possible in the United States.

We provided a draft of this report to EPA for its review and comment. We  received written comments from EPA that are reproduced in appendix I  and summarized below.

In its written comments, EPA stated that while the draft comprehensively  describes the challenges facing the TSCA and IRIS programs, it does not  appropriately address EPA’s extensive progress in implementing TSCA,  and EPA recommended that our final report include information regarding  its accomplishments under the new law. Specifically, we report on the  steps EPA has taken to respond to the requirements of the law because  in many instances, whether EPA’s response is legally sufficient is in  litigation, and GAO does not typically express a view on legal or factual  matters in dispute before a court. We have updated our report with  additional examples, which the agency provided in its comments, of steps  it has taken to implement TSCA.

In addition, EPA requested that we consider its progress made in  addressing and controlling toxic chemicals with respect to the five criteria  for removal from our high-risk list. The application of the high-risk criteria  was not within the scope of this report. Our forthcoming 2019 high-risk  update will address actions taken by agencies on the list, including EPA,  since the last update in 2017. EPA said that to monitor progress, it had  put into place a rigorous program; as a regular practice, EPA stated that  Deputy Assistant Administrators from the Office of Chemical Safety and  Pollution Prevention conduct monthly Business Review meetings with the  Office Directors, Deputy Office Directors, lead region representatives, and  other key staff. EPA stated that during these meetings they discuss their  organizations’ operations and performance, including TSCA  implementation status, using performance charts to track progress on  mission measures, identify and update countermeasures, and resolve  problems. However, over the year that we conducted our review, EPA  officials did not mention conducting such meetings and did not provide  documentation that such meetings took place.

Further, in its written comments, EPA provided technical comments on  the draft report, which we address as appropriate. In one comment, EPA  stated that instead of noting that the agency has successfully  implemented many statutory requirements, the draft report stated that  EPA responded to deadlines. We believe the report correctly  characterizes steps EPA has taken to implement TSCA, and, as noted  above, whether EPA’s response is legally sufficient is in litigation, and  GAO does not typically express a view on legal or factual matters in  dispute before a court. In another case, the technical comments  contradicted facts that we gathered during our review. For instance, while  EPA stated that the draft report incorrectly noted that most of the IRIS  staff had been working on TSCA activities, we provide further information  to support our original statement; we replaced the term ‘most’ with  specific data on the number of IRIS staff and the percentage of their time  that was devoted to TSCA activities.

Also in its technical comments, EPA stated that our analysis highlighted  uncertainty resulting from the agency’s recent activities to ensure IRIS  Program efforts were aligned with the highest priorities of the agency.  EPA acknowledged that this action did result in a delay but that in the  long term, it would ensure that EPA’s program and regional office  priorities are being addressed and that each office is fully engaged in the  development of IRIS assessments that will strengthen the agency’s ability  to address its mission for protecting human health and the environment.  However, as we state in our report, prior to releasing results from the  initial program and regional office survey, EPA leadership in ORD made a  second request for a prioritized list of chemical assessments. According  to officials from the IRIS office, who were queried for advice, the second  request was made verbally at a meeting and did not provide the offices  with information on the basis for selecting priorities or the reason for  limiting the number of assessments to three or four chemicals. In addition,  the ultimate priority list EPA issued in December 2018 reflected the  priorities of two program offices and did not provide evidence that other  EPA program offices had no interest in IRIS assessments. Because EPA  did not identify the basis for program offices to select priorities or the  reason for limiting the number of chemicals to assess, the process was  not transparent, leaving room for uncertainty.

EPA also provided additional technical comments, which we have  incorporated as appropriate.

We are sending copies of this report to the appropriate congressional  committees, the Administrator of the Environmental Protection Agency,  and other interested parties. In addition, the report is available at no  charge on the GAO website at http://www.gao.gov.

If you or your staff members have any questions about this report, please  contact me at (202) 512-3841 or gomezj@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on  the last page of this report. Key contributors to this report are listed in  appendix II.

Appendix I: Comments from the Environmental Protection Agency

Appendix II: GAO Contacts and Staff Acknowledgments

In addition to the contact named above, Diane Raynes (Assistant  Director), Summer Lingard-Smith (Analyst in Charge), Alisa Carrigan,  Tara Congdon, Richard P. Johnson, Amber Sinclair, and William Tedrick  made key contributions to this report. In addition Karen Howard, Dennis  Mayo, Dan Royer, and Sara Sullivan made important contributions.

Chemical Innovation: Technologies to Make Processes and Products  More Sustainable. GAO-18-307. Washington, D.C.: February 8, 2018.

Chemicals Management: Observations on Human Health Risk  Assessment and Management by Selected Foreign Programs.  GAO-16-111R. Washington, D.C.: October 9, 2015.

Chemical Assessments: Agencies Coordinate Activities, but Additional  Action Could Enhance Efforts. GAO-14-763. Washington, D.C.:  September 29, 2014.

Chemical Regulation: Observations on the Toxic Substances Control Act  and EPA Implementation. GAO-13-696T. Washington, D.C.: June 13,  2013.

Chemical Assessments: An Agencywide Strategy May Help EPA Address  Unmet Needs for Integrated Risk Information System Assessments.  GAO-13-369. Washington, D.C.: May 10, 2013.

Toxic Substances: EPA Has Increased Efforts to Assess and Control  Chemicals but Could Strengthen Its Approach. GAO-13-249. Washington,  D.C.: March 22, 2013.

Chemical Assessments: Challenges Remain with EPA’s Integrated Risk  Information System Program. GAO-12-42. Washington, D.C.: December  9, 2011.

Chemical Assessments: Low Productivity and New Interagency Review  Process Limit the Usefulness and Credibility of EPA’s Integrated Risk  Information System. GAO-08-440. Washington D.C: March 7, 2008.

High-Risk Series: An Update. GAO-09-271. Washington D.C: January  2009.

High-Risk Series: Progress on Many High-Risk Areas, While Substantial  Efforts Needed on Others. GAO-17-317. Washington D.C: February 15,  2017.

The EPA has a program that assesses the safety of chemicals used in consumer and industrial products. In the past, the program was criticized for slow results and a lack of transparency in the assessment process.

We found EPA made improvements in both areas of the assessment process. Its review process, for example, provided a clear view of the work behind its assessments.

However, between June and December 2018, EPA leadership directed the program to stop the assessment process during discussions about program priorities.

EPA has responded to initial statutory deadlines in the Toxic Substances Control Act, but challenges remain.