Bergeson & Campbell, P.C.

Bergeson & Campbell, P.C.

GAO Reviews EPA`s IRIS Assessment Efforts and Implementation of TSCA Reforms

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Courtesy of Bergeson & Campbell, P.C.

On March 4, 2019, the U.S. Government Accountability Office (GAO) published a report titled Chemical Assessments:  Status of EPA’s Efforts to Produce Assessments and Implement the Toxic Substances Control Act.  The report describes the extent to which the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program has addressed identified challenges and made progress toward producing chemical assessments; and assesses whether EPA has demonstrated progress implementing the Toxic Substances Control Act (TSCA).  GAO reviewed documents from the National Academy of Sciences (NAS) and EPA and interviewed EPA officials and representatives from two environmental and two industry stakeholder organizations.  GAO found that while EPA made improvements in the IRIS Program, between June and December 2018, EPA leadership directed the Program to stop the assessment process during discussions about program priorities.  GAO states that while EPA has responded to initial statutory deadlines in TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), challenges remain.

Why GAO Did This Study

EPA is responsible for reviewing chemicals in commerce and those entering the marketplace.  As reported in our February 21, 2019, memorandum, “EPA Releases Updated TSCA Inventory,” there are currently more than 40,000 active chemical substances in commerce, with more submitted to EPA for review annually.  The IRIS database contains EPA’s scientific position on the potential human health effects that may result from exposure to various chemicals in the environment.  GAO notes that 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 NAS recently commended, as reported in our April 12, 2018, blog item, “National Academies Find IRIS Program Has Made ‘Substantial Progress.’
 
Amended TSCA 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.  Information on TSCA developments such as the first draft TSCA chemical risk evaluation, significant new use rules that break new ground, and EPA’s working approach for identifying potential candidate chemicals for prioritization is available on our website.

What GAO Found

IRIS Program Chemical Assessments

GAO found that, while the IRIS Program has made progress in addressing identified process challenges, EPA deliberations have delayed progress on producing assessments.  GAO states that 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.  During its study, GAO discovered that the release of documents related to IRIS assessments was delayed for nearly six 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. 
 
GAO reports that, in June 2018, EPA leadership in the Office of Research and Development (ORD) reportedly told IRIS officials not to release any IRIS-associated documentation without a formal request from EPA program office leadership.  In August 2018, EPA program office leadership was asked to reconfirm which ongoing IRIS assessments their offices needed.  In late October 2018, leadership in ORD reportedly asked these offices to limit their requests further, to the top three or four assessments.  GAO states that at the same time, four months after IRIS assessments were stopped from being released, 28 of approximately 30 IRIS staff were directed to use 25 to 50 percent of their time to support TSCA implementation.
 
When EPA deliberations about the IRIS Program’s priorities were completed, a memorandum was issued on December 4, 2018, listing 11 chemical assessments that the IRIS Program would develop.  Although this was a reduction of the Program’s workflow from 22 assessments, GAO states that the memorandum “gave no reason for the reduction.”  GAO notes that it received this memorandum at the end of its review and did not have the opportunity to review the prioritization process that led to its drafting.
 
Two weeks later, on December 19, 2018, ORD released its IRIS Program Outlook, which provided an updated list of 13 assessments.  GAO states that two assessments were not included in the December 4, 2018, 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.  GAO notes that the absence of these four assessments from the December 2018 Outlook “could create confusion for stakeholders interested in them.”  EPA reportedly 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 GAO has 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, according to GAO, it remains to be seen when these assessments can be expected to move to the next step in the IRIS process or be completed.

EPA’s Implementation of New TSCA

GAO found that EPA has demonstrated progress in implementing TSCA by responding to TSCA’s statutory deadlines through the end of fiscal year 2018, including promulgating rules, developing guidance, and releasing reports.  According to GAO, 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.  GAO notes that 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.  Office of Pollution Prevention and Toxics (OPPT) officials stated to GAO that “they are trying to not anticipate the results of the litigation and, instead, address the outcome of each case as it is decided.”  OPPT officials “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, however, it may need to devote additional resources to implement the relevant provisions of TSCA.  For example, according to GAO, 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 issue final evaluations.
 
The Lautenberg Act greatly increased OPPT’s workload by enacting deadlines for completing existing chemical evaluations and requiring EPA to make a determination on the safety of a new chemical before it can be manufactured.  Partially because of the increased workload, some OPPT officials stated to GAO 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) stated that they do not have sufficient resources to do their work.  GAO states that this included staff from all five technical teams interviewed in the Risk Assessment Division, which is particularly affected by the heavy workload, according to OPPT officials and representatives from an industry stakeholder organization.  To address the staffing challenge, EPA has reassigned staff from other parts of EPA to OPPT.  For example, staff in OPPT’s Safer Choice Program were redeployed to the Chemical Control and Risk Assessment Divisions.  According to representatives from industry stakeholder organizations, it can be difficult to work with recently reassigned staff who may not, in all cases, be familiar with the chemicals on which they are working.  GAO states that according to representatives from an industry stakeholder organization, in some cases, OPPT staff is ill-prepared to make decisions about a premanufacture notice (PMN).  OPPT senior officials noted that there is always a learning curve for reassigned employees, “but they do not put new people in positions to make decisions on [PMNs].  They said that these decisions are never made by one person in a vacuum.”
 
OPPT officials and staff informed GAO 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 new TSCA’s provisions.  For example, the Chemical Control and Risk Assessment Divisions currently each handle both new and existing chemicals, and the planned reorganization will divide the divisions into new and existing chemicals.  According to GAO, staff have concerns about whether the new divisions will be adequately staffed, the timing of the reorganization, and their future placements, however.
 
GAO reports that EPA also faces challenges in developing guidance to ensure consistency in implementing new TSCA.  OPPT officials stated that, given the tight timelines that TSCA requires, they have not yet created all the necessary guidance for staff implementing the law.  According to GAO, “[o]fficials 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 that GAO interviewed are either currently updating their guidance, still developing their guidance, or have never developed guidance before.  Staff from two teams is developing the guidance as they apply it to their work.  GAO states that OPPT officials stated that that they are using some guidance that was in place before the Lautenberg Act was enacted, though they are working on updates.
 
Representatives from both industry stakeholder organizations interviewed by GAO stated that the new chemicals program “is too slow and unpredictable, which can negatively affect innovation.”  For example, according to representatives from one company, it submitted a PMN 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 new TSCA’s enactment in 2016.  No information was provided in the report that would help explain what could support such an extended review time.  According to EPA, it does not violate the mandated timelines because submitters agree to voluntarily suspend the review process.  Representatives from one industry stakeholder organization noted that as of December 2018, with the passage of time and greater familiarity with new TSCA, “OPPT’s decision making process has improved and is more predictable.” 
 
GAO reports that it interviewed representatives from industry stakeholder organizations who stated that delays motivate companies to introduce chemicals first in foreign markets.  According to one company, it developed a new technology in the U.S. 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.”  Instead, the company has decided to pursue commercialization in Europe, that 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 U.S.

Agency Comments

GAO provided a draft of its report to EPA for its review and comment.  EPA responded that while the draft report comprehensively describes the challenges facing TSCA implementation and the IRIS Program, it does not appropriately address EPA’s “extensive progress” in implementing TSCA, and EPA recommended that the final report include information regarding its accomplishments under new TSCA.  GAO notes that it reports only on the steps EPA has taken to respond to the requirements of new TSCA 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.  GAO updated its report with additional examples provided by EPA of steps it has taken to implement new TSCA.
 
EPA stated that to monitor progress made in addressing and controlling toxic chemicals, it has put into place a rigorous program; as a regular practice, Deputy Assistant Administrators from the Office of Chemical Safety and Pollution Prevention (OCSPP) conduct monthly Business Review meetings with the Office Directors, Deputy Office Directors, lead region representatives, and other key staff.  According to EPA, during these meetings, participants discuss their organizations’ operations and performance, including TSCA implementation status, and use performance charts to track progress on mission measures, identify and update countermeasures, and resolve problems.  GAO notes that over the year that it conducted its review, however, “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 that GAO addressed as appropriate.  GAO states that in one case, the technical comments contradicted facts that GAO gathered during its review.  For instance, while EPA stated that the draft report incorrectly noted that most of the IRIS staff had been working on TSCA activities, GAO revised the draft report to provide further information to support its original statement; it 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.

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