Regulatory Developments

EPA Provides Report to Congress on Its Capacity to Implement Certain Provisions of the Lautenberg Act

November 8, 2022

The U.S. Environmental Protection Agency (EPA) has provided a report to Congress on its capacity to implement certain provisions of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). The report provides point-in-time estimates of EPA’s current estimated capacity and resources needed to implement the 2016 Lautenberg Act amendments to the Toxic Substances Control Act (TSCA). TSCA Section 26(m) requires EPA to submit an initial report to Congress within six months of enactment of the Lautenberg Act and requires EPA to submit updated reports every five years. The report includes estimations of EPA’s capacity to conduct and publish EPA-initiated risk evaluations and manufacturer-requested risk evaluations; the resources necessary to conduct the minimum number of required EPA-initiated risk evaluations; the likely demand for manufacturer-requested risk evaluations and the anticipated schedule for accommodating that demand; EPA’s capacity to promulgate TSCA Section 6(a) risk management rules as required to address unreasonable risks identified in risk evaluations conducted and published under TSCA Section 6(b); and EPA’s actual and anticipated efforts to increase capacity to conduct and publish risk evaluations under TSCA Section 6(b).

EPA-Initiated Risk Evaluations

In November 2016, EPA identified the first ten chemical substances for risk evaluation. EPA completed the risk evaluations between June 2020 and January 2021, missing the statutory deadline for completion for all but one of the risk evaluations. As reported in our July 1, 2021, memorandum, on June 30, 2021, EPA announced its intent to take several actions affecting the first ten chemical substance risk evaluations. EPA intends to supplement formally the 1,4-dioxane risk evaluation to consider additional exposure pathways, such as drinking water and ambient air, and conditions of use for which 1,4-dioxane is generated as a byproduct. For six of the first ten chemical substances, EPA plans to examine further whether the previous Administration’s policy decision to exclude certain exposure pathways (i.e., air, water) from the risk evaluations may have led to a failure to identify potential unreasonable risks from these exposure pathways. EPA’s view is that the approach also resulted in a failure to address appropriately the statutory requirement to evaluate potential exposures to potentially exposed or susceptible subpopulations, including fenceline communities. Depending on the outcome of this screening-level analysis, EPA states that it may move forward to proposed risk management rulemakings or may conduct a more comprehensive exposure assessment of fenceline communities and formally supplement the risk evaluation for that chemical with the new information.

EPA notes that it also is revisiting the assumption that personal protective equipment (PPE) is always properly used in occupational settings when making risk determinations in a TSCA risk evaluation for a chemical substance. According to EPA, this assumption was not appropriate because, by its own admission, many of the Occupational Safety and Health Administration’s (OSHA) standards are outdated and inadequate for ensuring protection of worker health. Most of OSHA’s permissible exposure limits (PEL) were issued shortly after adoption of the Occupational Safety and Health (OSH) Act in 1970 and have not been updated since that time. EPA plans to consider information on the use of PPE, or other ways industry protects its workers, as a potential way to address any identified unreasonable risk during the risk management process. EPA states that this shift could change some of the risk conclusions for some conditions of use for six of the first ten chemical substances for which “no unreasonable risk” findings were made based on the use of PPE but does not create a need for new analyses of the chemicals.

As reported in our December 20, 2019, memorandum, in December 2019, EPA published the final list of high-priority chemicals and commenced risk evaluations on those substances. As reported in our April 7, 2020, and April 21, 2020, memoranda, EPA released the draft scope documents for these chemical substances for public comment. EPA published the final scope documents in September 2020, as reported in our September 4, 2020, memorandum. Statutory timelines require EPA to publish final risk evaluations within three years of initiation of the risk evaluations, with a possible six-month extension. EPA states that “[g]iven current resources, without reprioritizing other work, the EPA does not anticipate completing any of these risk evaluations by the statutory deadline.”

Manufacturer-Requested Risk Evaluations

To date, EPA has received four manufacturer requests for risk evaluation: diisodecyl phthalate (DIDP); diisononyl phthalate (DINP); octamethylcyclotetra-siloxane (D4); and octahydro-tetramethyl-naphthalenyl-ethanone (OTNE).

Risk Management

TSCA Section 6(h) includes a specific process to address certain persistent, bioaccumulative, and toxic (PBT) chemicals on the 2014 Update to the TSCA Work Plan. EPA issued final rules for five PBT chemicals on January 6, 2021. On March 8, 2021, EPA announced it was opening a 60-day comment period for the public to provide new input on whether the rules sufficiently reduce exposure to these chemicals, including exposures to potentially exposed or susceptible subpopulations, and the environment, compliance issues associated with the final rule on phenol, isopropylated phosphate (3:1) (PIP (3:1)), and whether to consider additional or alternative measures or approaches.

On September 3, 2021, EPA announced that it is considering revising all five of the final rules for PBT chemicals to reduce exposures further, promote environmental justice, and better protect human health and the environment. According to EPA, it plans to issue a proposal for a new separate rulemaking for PBT chemicals in spring 2023. EPA notes that the provisions of the January 2021 rules remain in effect while EPA works on this new rulemaking effort, except that EPA extended certain compliance dates for PIP (3:1) to March 8, 2022, and then again to October 31, 2024, to address the hardships inadvertently created by the original applicable compliance dates in the January 2021 final rule and ensure that supply chains are not disrupted for key consumer and commercial goods (notably electronics). More information is available in our September 3, 2021, and March 7, 2022, memoranda.

Capacity to Implement Specific Provisions of the Law Regarding Risk Evaluations and Regulatory Actions

According to the report, EPA’s TSCA program undertook multiple actions to address well-known capacity issues such as leveraging existing resources within the Agency to carry out the TSCA mandates by conducting a reorganization of the Office of Chemical Safety and Pollution Prevention (OCSPP) in 2020 to allocate additional resources for existing and new chemical reviews, announcing details for specific mission critical occupations, training staff on risk management, and drawing on expertise across the Agency from the Office of Research and Development (ORD), the Office of Air, and the Office of Land and Emergency Management (OLEM) to aid in evaluating chemicals for risk management action. EPA also identified needs in a Workforce Analysis because of audits initiated by the U.S. Government Accountability Office (GAO) and EPA’s Office of Inspector General (OIG). The report notes that EPA’s TSCA program funding level has remained flat for six years and is essentially the same as it was before the law was amended in 2016. According to EPA, these funding levels “will not allow the program the ability to develop the capacity to meet its statutory obligations, and to deliver on the promise of TSCA reform.”

Improved Effectiveness in Implementing the Law

EPA states that it has taken “numerous major steps” in recent years to improve its effectiveness in implementing TSCA. Most recently, as reported in our February 25, 2022, blog item, in February 2022, EPA launched a new effort to improve the process of and ensure the use of innovative science in reviewing new chemicals before they enter the marketplace. Through this effort, OCSPP proposed to develop and implement a multi-year collaborative research program in partnership with ORD and other federal entities focused on approaches for performing risk assessments on new chemical substances under TSCA. EPA states that this multi-year research program will refine existing approaches and develop and implement new approach methodologies (NAM) to ensure the best available science is used in TSCA new chemical evaluations. Key areas proposed in the TSCA New Chemicals Collaborative Research Program include:

  • Updating OCSPP’s approach using data from structurally similar chemicals to determine potential risks from new chemicals. This will increase the efficiency of new chemical reviews promoting the use of the best available data to protect human health and the environment;
     
  • Digitizing and consolidating information on chemicals to include data and studies that currently only exist in hard copy or in disparate TSCA databases. EPA will combine the information with publicly available sources to expand the amount of information available, enhancing chemical reviews and enabling efficient sharing of chemical information across EPA;
     
  • Updating and augmenting the models used for predicting a chemical’s physical-chemical properties and environmental fate/transport, hazard, exposure, and toxicokinetics to provide a suite of models to be used for new chemicals assessments. According to EPA, the goal of this effort is to update the models to reflect the best available science, increase transparency, and establish a process for updating these models as science evolves;
     
  • Exploring ways to integrate and apply NAMs in new chemicals assessments, reducing the use of animal testing. The goal of this is to develop a suite of accepted, fit-for-purpose NAMs that could be used by external stakeholders for data submissions under TSCA as well as informing and expanding new chemical categories; and
     
  • Developing a decision support tool that integrates the various information streams specifically used for new chemical risk assessments. The decision support tool will more efficiently integrate all the data streams (e.g., chemistry, fate, exposures, hazards) into a final risk assessment and transparently document the decisions and assumptions made. This will facilitate the new chemicals program tracking decisions over time and evaluating consistency within and across chemistries.
     

According to the report, EPA has developed experience in conducting existing chemical risk assessments under TSCA for chemicals listed on the TSCA Work Plan, has increased its experience in the five years since the Lautenberg Act was enacted through work on existing chemical substance risk evaluations, and has used that experience to improve its management of the program. In 2020 and 2021, management and staff members participated in discussions to identify lessons learned from developing the first ten risk evaluations, identifying best practices developed during the risk evaluation process; identifying solutions to problems common to multiple risk evaluations that, when addressed, produce increased efficiencies in risk evaluation production; and identifying common areas in the risk evaluations for which improved technical methods may lead to more robust assessments. The report includes the following examples of best practices developed during the risk evaluation process:

  • Creation of a library of external and peer review comments and responses that arise during risk evaluation. This will enable staff to address efficiently recurring questions with pre-approved responses;
     
  • Documentation of a technical process for curating scientific citations, hundreds of which may occur in a single risk assessment; and
     
  • Documentation of a series of standard operating procedures and workflows for the different kinds of disciplinary analyses needed to develop a risk evaluation. This will provide clarity in conducting future analyses and training staff in assessment methods.
     

According to the report, examples of solutions to common problems include:

  • Implementation of a risk assessment training series to provide consistent high-level training in risk assessment practices for staff;
     
  • Development of a standard template for risk evaluation documents to ensure that content is comprehensive, consistently organized, easy for external readers to understand, and effective in supporting EPA’s development of risk management rules;
     
  • Creation of a style guide and template to streamline development of consistently formatted risk assessment documents, which often reach 1,000 pages in length; and
     
  • Establishment of a central project management tool for achieving milestones as well as facilitating alignment of skill sets with project needs.
     

Examples of areas for which improved technical methods may be warranted include:

  • Development of scientific approaches for evaluating aggregate (multi-pathway) and cumulative (multi-toxicant) risk;
     
  • Development of broader scientific approaches for assessing risks to potentially exposed or susceptible subpopulations to broaden the relevance of risk assessments and better support EPA’s focus on environmental justice; and
     
  • Development of modernized approaches for assessing byproducts and transformational products associated with chemical substances undergoing risk assessment to better understand and manage the entire lifecycle of risk associated with chemicals of interest.
     

Commentary

EPA’s report to Congress reflects the challenges, opportunities, and lessons learned during EPA’s implementation of amended TSCA. Many of EPA’s proposed actions reflect the need for quality, consistency, and transparency in EPA’s actions. Developing policies and procedures that EPA can employ across the teams that are performing the risk evaluations is a vital step in EPA developing risk evaluations that reflect the best available science and credibly inform risk management decisions.

EPA again focuses on its capacity to implement the Lautenberg Act. There is little disagreement among stakeholders that EPA needs additional resources, both in terms of employees and extramural funding. This report provides more details when compared to the January 2017 report written by the Obama Administration. We agree that OCSPP needs additional staff and funding; we are also of the view that additional resources will not be sufficient to address all of the many challenges EPA is facing. Not the least of which is that additional resources for OCSPP will not achieve the intended purpose if key other parts of EPA, such as the groups overseeing human resources, contracting, information technology, and publishing Federal Register notices, do not have the resources necessary to support OCSPP’s expanded responsibilities.

EPA’s report also raises some other issues with which we have disagreed in the past. In particular, the report reiterates EPA’s view that OSHA obligations are not protective of workers. There is little disagreement that many OSHA PELs are out of date and not sufficiently protective (as EPA states in the report). That does not mean that all OSHA standards are entirely ineffective. EPA continues to cite to OSHA’s top ten standards that lead to citations without acknowledging that those standards are not necessarily related to the chemical industry. For example, #8 on the OSHA list is a citation for lack of eye and face protection within the construction industry; if you drill down to the chemical industry, such citations are much rarer. EPA also reiterates its view that “OSHA standards do not cover risks to all potentially exposed or susceptible subpopulations of workers, such as self-employed individuals and public sector workers not covered by [OSHA].” While this is true, EPA does not explain why it views such workers as being like workers at industrial chemical facilities rather than like consumers. EPA’s rationale seems to suggest that because some workers under some circumstances (such as a municipal employee) are not protected by OSHA, then no workers are protected by OSHA, thereby necessitating EPA issuing protective regulations. This makes no sense. EPA should evaluate risk to workers, but in doing so, the Lautenberg Act requires that it must also consider all reasonably available information and evaluate whether the lack of worker protection is reasonably foreseen (a term that, according to explicit statements by Congress, excludes misuse). A construction worker is, in our view, not a good model for a worker at a chemical plant, so lack of eye protection for the former should not be used to infer a lack of eye protection for the latter. EPA also has not provided a basis for its belief that self-employed individuals would not take reasonable measures to protect themselves, necessitating that EPA issue regulations forcing an individual to protect themself. Finally, EPA reiterates its intent to withdraw previously issued orders for the first ten chemicals as part of its “whole chemical” approach. EPA issued orders for some conditions of use for some chemicals when EPA concluded that when certain PPE was used, there was not an unreasonable risk. Whether EPA withdrawing the orders is contemplated in the statute, or whether EPA’s “whole chemical” approach is justifiable are questions that remain to be resolved.

We are pleased to see that, in this report, EPA corrects its previous representations that, prior to the Lautenberg Act, only 20 percent of premanufacture notices (PMN) were reviewed -- an assertion without any basis or merit. In this report, EPA states that “EPA made written determinations on approximately 20% of submissions.” Although not explicitly stated in the report, we suspect that EPA is referring to “standard reviews” -- a misnomer for cases in which a PMN was not in one of EPA’s chemical categories, necessitating a more in-depth review. That is a very different representation from EPA reviewing only 20 percent of cases. We are pleased that EPA has rediscovered a category approach to its review of new chemicals, as demonstrated by EPA’s efforts on biobased fuels and modified cathode active materials. EPA can and should use its extensive experience and data collections in reviewing new chemicals to inform later reviews. It is both inefficient and unjustifiable for EPA to review each new chemical de novo; EPA should review each new chemical to evaluate whether it is within one of EPA’s identified categories and, if so, follow its guidance for such substances. The many efforts EPA describes in this report related to standardizing its reviews and developing information systems to make reviews more efficient reflect this laudable effort.

EPA uses nearly a page to discuss its scientific integrity efforts. Use of the best available science and a weight of scientific evidence approach is not only the correct thing to do from a scientific standpoint, but it is required by the statute. EPA’s list of six measures it has undertaken or is undertaking to better ensure scientific integrity are all welcome. We hope that these measures both achieve the intended aim and provide more confidence to stakeholders that EPA is meeting its statutory obligations and making decisions based on the best available science, rather than selecting science based on a preferred outcome.

In summary, our view is that the report reflects the ongoing challenges EPA faces in implementing the Lautenberg Act and lays out some of the many efforts that EPA is currently undertaking or is beginning to implement that may lead to more transparent, efficient, predictable, and scientifically and legally supportable decisions across TSCA programs.


 
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