IRIS and TSCA—The challenge of chemical assessments
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March 14, 2019
IRIS and TSCA—The challenge of chemical assessments

EPA wrestles with budget and races against time

Chemical assessments, a core activity at the EPA, are conducted under two separate but closely related programs—the Integrated Risk Information System (IRIS) and implementation of the Toxic Substances Control Act (TSCA) and its 2016 amendments. The Government Accountability Office (GAO) recently released a report on how these two programs are completing their mission to evaluate the risks chemicals pose to human health and the environment, transmit that information to the EPA offices that make regulatory decisions, and make the information available to the public. Generally, the GAO found that IRIS has improved its operation by streamlining administration and installing modern software, but work appears to be stalling because of decisions by upper management. Meanwhile, implementation of TSCA is occurring on multiple levels, but there are questions about whether the EPA offices shouldering the efforts have the resources and staff to meet all the Agency’s statutory deadlines.

Here we summarize the GAO’s findings on how these two EPA chemical programs are performing.

IRIS

The IRIS program was introduced in 1985 to develop consensus opinions within the EPA about the health effects from lifetime exposure to chemicals. As of November 2018, information on 510 chemicals was included in the IRIS database.

“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,” says the GAO. “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.”

According to the GAO, the primary work of the IRIS staff is to review the scientific literature on chemicals, extract relevant data, derive chemical toxicity values, and integrate the evidence into draft assessments. The draft goes through internal agency and interagency review, public comment, and peer review. After making revisions to address comments, the draft is sent through another round of internal and interagency review before the final assessment is posted to the IRIS website. Approximately a dozen staff members are drawn from several different backgrounds (e.g., toxicologists and epidemiologists) to work on each assessment.

In 2011 and 2014, the National Academy of Sciences recommended ways the IRIS program could be improved, particularly by shortening the length of time it took to complete chemical assessments. Based on those recommendations, as well as suggestions from industry and other stakeholders, the GAO states that the EPA has implemented the following enhancements:

  • IRIS officials began incorporating lean management techniques to improve efficiency and effectiveness by reducing unnecessary process steps and waiting time. Also, a model was introduced to train staff to be proficient in all phases of the systematic review process (i.e., screening, data extraction, study evaluation, and evidence synthesis). This modularity makes it easier for staff members to work across teams and on multiple projects, assisting with systematic review needs while also contributing in their areas of expertise.
  • The program adopted software to enable staff to perform literature searches faster. The software filters search results, allowing staff to more quickly find the most relevant information for an assessment. Use of software tools with machine-learning capabilities facilitate the staff’s ability to screen studies for relevance more quickly compared with approaches used before 2017. Previously, much of the development of an assessment was manual (i.e., using a spreadsheet). For example, contactors working manually on one 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 members 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.
  • IRIS staff members are tailoring assessments to program and regional office needs, called fit-for-purpose assessments. 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, thereby reducing the amount of time IRIS staff needed to search for information; synthesize it; and draft, review, and issue an assessment. The fit-for-purpose assessments have also shortened the peer review process.
  • Transparency has been improved by using a structured and transparent process for identifying relevant studies, reviewing their methodological strengths and weaknesses, integrating these studies as part of a weight-of-evidence analysis, and increasing outreach to stakeholders and the public in terms of both the frequency and the depth of content about assessment preparation. Better communication is also occurring between the IRIS program and the EPA program and regional offices about overall program priorities and individual assessments.

New directions from leadership

These and other changes resulted in the IRIS program meeting internal deadlines for work on nine different chemical assessments from January through May 2018.  However, beginning in June 2018, EPA leadership made changes that affected the program’s production of assessments. Specifically, top management in the EPA’s Office of Research and Development, in which the IRIS program is housed, informed IRIS managers that they could not release an assessment without a formal request for that assessment from the heads of a program office. Also, in December 2018, leadership issued a memo that reduced the number of assessments the IRIS program would develop from 22 to 11. IRIS officials told the GAO that the 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.

The IRIS program has been funded at about $38 million annually since fiscal year (FY) 2013. However, the administration has sought to reduce funding for FYs 2018 and 2019 to $22.5 million and $22.2 million, respectively. Congress did not support the reductions, but IRIS officials said the proposed budget cuts have caused them concern about whether they will have sufficient resources to expand assessments in the future. Also, as explained below, the EPA has been directing IRIS staff to work on TSCA implementation.

TSCA

TSCA is a 1976 law that in 2016 underwent a revision that created significant new requirements for assessing risks posed by chemicals in commerce. The amendments are packed with deadlines the EPA must meet, including the requirement to complete risk evaluations by December 2019 for the first 10 chemicals identified under the amendments. The GAO found that Agency resources appear to be inadequate to ensure that the risk evaluations and other requirements under the amendments can be completed on time. Concerns about meeting TSCA’s statutory deadlines have forced EPA leadership to have IRIS staff members spend up to 50 percent of their time on TSCA implementation. This may not be good news for non-TSCA activities at the EPA.

“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,” says the GAO.

There is also legal uncertainty about how the EPA is carrying out its TSCA responsibilities. Mainly, environmental and public health groups have filed suits challenging the EPA’s decision to omit legacy uses of chemicals from its TSCA risk evaluations; legacy uses are those for which a chemical is no longer marketed. Also, environmental groups are asking the court to find that the EPA is unlawfully expanding the range of people who may assert business confidentiality claims about chemicals in the TSCA Inventory. EPA officials told the GAO that they are trying not to anticipate the results of these cases, but should the courts rule against the Agency, the implications for TSCA implementation are not promising.

“If EPA loses any of these lawsuits, it may need to devote additional resources to implement the relevant provisions of TSCA,” states the GAO. “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.”

Achievements

Despite the threat of lawsuits, the EPA has made progress in implementing TSCA. The initial 10 chemical risk evaluations are progressing, guidance was issued for stakeholders who wish to develop and submit draft risk evaluations, and four final rules were issued—the risk prioritization rule, which explains the EPA’s process for prioritizing existing chemicals for risk evaluation; the risk evaluation process rule, which explains how the Agency conducts risk evaluations on existing chemicals; the inventory notification rule; and a framework rule that authorizes the EPA to collect fees for carrying out a number of different activities under TSCA.

But given that the initial 10 risk evaluations have not been issued, the GAO cautions that it is difficult to tell how far along the EPA actually is in satisfying that key responsibility. The GAO also notes that the EPA is facing challenges in developing guidance to ensure consistency in implementing the law. EPA 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,” said the GAO.

New chemicals

There have also been glitches in the new chemical approval process. Representatives from two industry stakeholder organizations told the GAO that the new chemicals program is too slow and unpredictable, which can negatively affect innovation. For example, one company informed the GAO 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 with the 90 days it typically took to obtain approval before the 2016 amendments. The EPA can request extensions, and submitters can voluntarily suspend the review process; therefore, the overall process can extend beyond the 90-day requirement. These delays can have a detrimental effect on the U.S. economy. The GAO explains:

“Representatives we interviewed from industry stakeholder organizations 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.”

The GAO provided a draft of its report to the EPA, which responded that the GAO correctly identified the challenges facing the IRIS and TSCA programs, but focused too little on what the Agency is achieving in the two chemical programs.

The GAO’s report is here.

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