Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on August 22, 2022, that as part of its commitment to re-evaluate policies and practices under the Toxic Substances Control Act (TSCA) New Chemicals Program to ensure they adhere to statutory requirements and the Biden Administration’s executive orders and directives, it has updated its policy to discontinue the use of exposure modeling thresholds when assessing the health and environmental risks of new chemicals under TSCA. According to EPA, due in part to the automation of modeling, it has become less burdensome to complete these calculations. Furthermore, according to EPA, removing the thresholds supports President Biden’s Executive Order 13985, “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government,” which calls on federal agencies to advance equity, including by reviewing and revising as needed government policies and programs impacting underserved communities.
 
The New Chemicals Program will implement this change by making minimal changes to the coding in the New Chemical Review application to remove the thresholds and will update standard operating procedures and training materials for exposure and human health risk assessors. EPA states that it will implement this policy change “as soon as feasible.” According to EPA, despite the resource challenges it is currently facing in the TSCA program, it anticipates that the change “will have minimal impact on the amount of time it takes to complete new chemical reviews and that the benefits gained from a more comprehensive accounting of all potential air and water releases will help ensure any needed protections are in place before a new chemical can come to market.”
 
More information and a detailed commentary that discusses thresholds of toxicological concern (TTC) are available in our August 22, 2022, memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on May 19, 2022, the availability of the meeting minutes and final report for the March 15-17, 2022, Science Advisory Committee on Chemicals (SACC) virtual meeting regarding EPA’s proposed Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0 under the Toxic Substances Control Act (TSCA). According to the meeting minutes and final report, SACC “agreed that the methodological document was well organized and generally well written.” SACC states that it “had difficulty reproducing results that were relevant to understanding and reviewing the document and indicated multiple limitations and uncertainties,” however. SACC suggested the methodology could only be used as part of a tiered approach to evaluate risk to fenceline communities and should not be used to evaluate risks in isolation. The screening level approach may be protective for the specific exposure pathways included, but it may not be protective overall because potential key exposure pathways are excluded and because it does not consider cumulative exposures, multiple source exposures, aggregate exposures, and double/aggregate and occupational exposures from workers living near and working at the facilities. Some SACC members also suggested that additional risk factors, such as stress, poverty, cultural practices, and diet, should be considered for a comprehensive assessment.
 
The meeting minutes and final report states that the accuracy and/or completeness of the data used to develop the screening analysis were not adequately supported in the document, and SACC decided it did not defensibly represent actual exposure of fenceline communities. Overall, SACC indicated the basis for several model inputs was insufficiently transparent and that, in particular, daily life activities of all communities disproportionately impacted by chemical exposures was missing in this current version. SACC recommended the term “fenceline” be refined to include the characteristics, behaviors, and realities of communities exposed through means that are not dependent on being within a limited radius from a chemical facility. SACC agreed that Version 1 of the screening tool for fenceline communities “is currently not adequate for evaluating potential exposures relevant to tribes, indigenous populations, subsistence lifestyles, cultural practices, or other unique circumstances. The pathways by which people in unique communities are exposed to chemicals of the contaminated areas are much broader than those represented in the current defining criteria of ‘Fenceline Communities.’” To make the tool applicable for any unique community, the meeting minutes and final report state that additional exposure scenarios and relevant data must be applied.
 
SACC recommended that knowledgeable community representatives “be intrinsically involved for perspective on how such information is applied in a screening endeavor, as well as the relevance and pedigree of values used to inform exposure algorithms, and relevance of default data and assumptions.” Complementary to this process is the need for enhanced and meaningful outreach to “fenceline communities” and all parties interested in these screens. SACC offered specific commentary and suggestions, along with a collection of references. A meeting transcript is available.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On March 15-17, 2022, the U.S. Environmental Protection Agency (EPA) held a meeting of the Science Advisory Committee on Chemicals (SACC) to peer review EPA’s “Draft TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0” (screening methodology). As reported in our January 24, 2022, memorandum, EPA will use the screening methodology to evaluate potential chemical exposures and associated potential risks to fenceline communities in its Toxic Substances Control Act (TSCA) risk evaluations. EPA presented its screening methodology, as well as the results of applying the screening methodology to 1-brompropane (air pathway), n-methylpyrrolidone (water pathway), and methylene chloride (air and water pathway). EPA will use the scientific advice, information, and recommendations from SACC, as well as public comments, to inform the final protocol. EPA has posted the following materials:


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has reopened the online dockets for 20 high-priority substances. According to the December 9, 2021, memorandum authorizing the re-opening of the dockets, EPA is re-opening these dockets to receive use, hazard, exposure, and any other information that can help inform their risk evaluations. Information must be submitted by June 9, 2022, when EPA will close the dockets. Information submitted to the docket should be identified by the docket identification (ID) number associated with the relevant chemical. The 20 high-priority chemicals are:

  • p-Dichlorobenzene;
  • 1,2-Dichloroethane;
  • trans-1,2-Dichloroethylene;
  • o-Dichlorobenzene;
  • 1,1,2-Trichloroethane;
  • 1,2-Dichloropropane;
  • 1,1-Dichloroethane;
  • Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic acid, 1,2-dibutyl ester);
  • Butyl benzyl phthalate (BBP) (1,2-Benzene-dicarboxylic acid, 1-butyl 2-(phenylmethyl) ester);
  • Di-ethylhexyl phthalate (DEHP) (1,2-Benzene-dicarboxylic acid, 1,2-bis(2-ethylhexyl) ester);
  • Di-isobutyl phthalate (DIBP) (1,2-Benzene-dicarboxylic acid, 1,2-bis-(2-methylpropyl) ester);
  • Dicyclohexyl phthalate;
  • 4,4'-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA);
  • Tris(2-chloroethyl) phosphate (TCEP);
  • Phosphoric acid, triphenyl ester (TPP);
  • Ethylene dibromide;
  • 1,3-Butadiene;
  • 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB);
  • Formaldehyde; and
  • Phthalic anhydride.

The docket ID number and contact information for each chemical lead is available in the memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On August 31, 2021, the U.S. Environmental Protection Agency (EPA) released the final scope documents for the Toxic Substances Control Act (TSCA) risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP). 86 Fed. Reg. 48695; 86 Fed. Reg. 48693. In its August 31, 2021, press release, EPA notes that both DIDP and DINP “belong to a family of chemicals called phthalates and are commonly used as plasticizers in the production of plastic and plastic coating to increase flexibility.”
 
According to EPA, the final scope documents reflect the policy changes on risk evaluations announced in June 2021. This includes plans to consider exposure pathways that may be regulated outside of TSCA, like air and water, and potential for exposures to fenceline communities (i.e., communities near industrial facilities). EPA states that “[a]ssumptions that personal protective equipment (PPE) in occupational settings will always be properly utilized will not be used as the basis for the risk determination. Use of PPE, and other ways industry protects its workers, will be assessed during the risk evaluation and considered as potential ways to address unreasonable risks during the risk management process.” More information on the policy changes is available in our July 1, 2021, memorandum.
 
The final scope documents explain EPA’s plan for the risk evaluations, including the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA will consider. The documents also include a description of the reasonably available information and the best available science approaches that EPA will use; a conceptual model that outlines the potential hazards and exposures throughout the life cycle of the chemical; an analysis plan to identify the approaches and methods EPA will use to assess health and environmental risks; and a plan for peer review. More information will be available in a forthcoming memorandum that will be posted on our website.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on August 6, 2021, that it will provide $9,272,545 in funding to seven institutions for research to estimate better children’s chemical exposures from soil and dust ingestion. According to EPA, the research will focus on improving estimates of children’s ingestion rates of chemicals such as lead, mercury, polychlorinated biphenyls (PCBs), and asbestos. EPA states that “[a]ccurate, comprehensive measurements of soil and dust ingestion rates are critical for effective risk assessment, reduction, mitigation, and prevention measures.” The following researchers are receiving funding through EPA’s Science to Achieve Results (STAR) program to help improve children’s health:

  • Emory University, Atlanta, Georgia, will conduct a community-based research study to understand and mitigate chemical contaminant exposure among children in neighborhoods with high lead and heavy metal contamination in soils around West Atlanta;
  • Florida International University, Miami, Florida, will estimate soil and dust ingestion rates in children by identifying specific tracers of dust and soil exposure combined with relevant environmental information;
  • Johns Hopkins University, Baltimore, Maryland, will create an integrated and innovative portfolio of tools and approaches to assess dust and soil exposures for children ages six months to six years via activity pattern and tracer studies;
  • New York University, New York, New York, will evaluate specific home environment factors and practices that lead to elevated levels of individual toxic substances ingestible by infants. According to EPA, the researchers hope to evaluate mitigation strategies to reduce infants’ exposure to harmful chemicals in household dust;
  • North Carolina Agricultural and Technical State University, Greensboro, North Carolina, will obtain data on dust loading on various objects and surfaces in children’s homes, foods, and children’s hands. The researchers will also conduct computer-aided investigations about children’s hand contacts and mouthing patterns;
  • University of California Davis, Davis, California, will develop an innovative method for determining children’s dust ingestion rates using unique tracer compounds identified in household dusts; and
  • University of Nevada-Reno, Reno, Nevada, will develop a behavior-driven dust and soil ingestion model to predict the dust and soil ingestion rate from children’s microenvironmental features and behavioral factors.

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on July 27, 2021, that it will provide $3.8 million in funding to create two EPA Science to Achieve Results (STAR) Centers for Early Lifestage Vulnerabilities to Environmental Stressors. The centers will focus on early lifestage exposures to chemicals and non-chemical environmental stressors and how these exposures may impact early childhood developmental health. EPA states that scientific research suggests that exposures to pollutants and non-chemical stressors during early lifestages may be crucial determinants of lifetime health. Exposures to cumulative mixtures of chemicals, along with other stressors, such as poverty, limited access to services, and changing environmental conditions, may pose developmental and lifelong health risks. According to EPA, accurate and comprehensive assessments of cumulative impacts are needed to make sound decisions regarding risk reduction, mitigation, and prevention measures. Each center will focus on two individual research projects:

  • Research Triangle Institute (RTI) International, Research Triangle Park, North Carolina:
    • Evaluating the Causal Impacts of Early Life Chemical Exposures on Neurodevelopmental Functioning in Early Childhood -- Researchers will identify the occurrences and types of chemicals found in toddlers’ caregiving environments and evaluate how these cumulative chemical exposures are associated with neurodevelopmental functioning in early childhood; and
    • Investigating Whether the Caregiving Environment Moderates the Impact of Early Life Chemical Exposures on Neurodevelopmental Functioning in Early Childhood -- Researchers will investigate whether home caregiving environments alter the impacts of early life chemical exposures on neurodevelopmental outcomes in early childhood.
  • University of North Carolina (UNC) at Chapel Hill, Chapel Hill, North Carolina:
    • Early Life Exposure and Neurobehavioral Development -- Researchers will leverage an ongoing, longitudinal study of normative brain development, the UNC Baby Connectome Study, to examine the role that early life exposure to phthalates and other chemicals plays in early childhood behavior, memory, language and motor development, and social cognition; and
    • Neural Substrates of Prenatal and Early Life Neurotoxicity Using Non-Invasive Imaging Methods -- Researchers will work to improve the understanding of the relationships between prenatal and early life exposures and structural and functional brain development, particularly in the third trimester of pregnancy, an important time for brain development.

 

By Lynn L. Bergeson and Carla N. Hutton
 

On July 27, 2021, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) will hold a public meeting to engage with interested stakeholders on the development of a proposed rule for implementing a tiered data collection strategy to help inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures under the Toxic Substances Control Act (TSCA). According to EPA, it currently primarily collects exposure-related data through the TSCA Chemical Data Reporting (CDR) process. EPA is interested in ensuring that data collection strategies provide information to meet better its basic chemical data needs, such as information related to exposure, health, and ecotoxicity. To this end, EPA states that it is exploring a data reporting rule that is tiered to specific stages of the TSCA existing chemicals program: identifying a pool of substances as potential candidates for prioritization; selecting candidate chemicals for and completing the prioritization process; and assessing high-priority substances through a robust risk evaluation, which may be followed by risk management actions (depending on the outcome of the risk evaluation). According to EPA, feedback from the public meeting and comments received will help inform its development of a proposed rule. The meeting will be held virtually via WebEx on July 27, 2021, from 1:00 to 3:00 p.m. (EDT). Those who would like to make a comment during the meeting must register by 6:00 p.m. EDT on July 22, 2021. Those who would like to participate in listen-only mode must register by 6:00 p.m. EDT on July 26, 2021. Written comments are due August 15, 2021.


 

By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on March 29, 2021, that it is evaluating its policies, guidance, templates, and regulations under the Toxic Substances Control Act (TSCA) new chemicals program to ensure they “adhere to statutory requirements,” the Biden-Harris Administration’s executive orders, and other directives.  EPA identified several instances where its approach for making determinations and managing risks associated with new chemicals can, according to EPA, more closely align with TSCA’s requirements to ensure protections for human health and the environment, including the use of significant new use rules (SNUR) and assumptions related to worker exposures.  EPA states that it will stop issuing determinations of “not likely to present an unreasonable risk” based on the existence of proposed SNURs.  According to EPA, “[r]ather than excluding reasonably foreseen conditions of use from EPA’s review of a new substance by means of a SNUR, Congress anticipated that EPA would review all conditions of use when making determinations on new chemicals and, where appropriate, issue orders to address potential risks.”  Going forward, when EPA concludes that one or more uses may present an unreasonable risk, or when EPA believes that it lacks the information needed to make a safety finding, EPA will issue an order to address those potential risks.

EPA states that as has been the “long-standing practice,” it intends to continue issuing SNURs following TSCA Section 5(e) and 5(f) orders for new chemicals to ensure the requirements imposed on the submitter via an order apply to any person who manufactures or processes the chemical in the future.  EPA notes that this ensures that other manufacturers of the same new chemical substance are held to the same conditions as the submitter subject to the TSCA Section 5(e) or 5(f) order.

EPA states that it now intends to ensure necessary protections for workers identified in its review of new chemicals through regulatory means.  According to the announcement, where EPA identifies a potential unreasonable risk to workers that could be addressed with appropriate personal protective equipment (PPE) and hazard communication, EPA will no longer assume that workers are protected adequately under the Occupational Safety and Health Administration’s (OSHA) worker protection standards and updated safety data sheets (SDS).  Instead, EPA will identify the absence of worker safeguards as “reasonably foreseen” conditions of use, and mandate necessary protections through a TSCA Section 5(e) order, as appropriate.

Commentary

The first policy change -- that the Office of Pollution Prevention and Toxics (OPPT) will no longer employ the “non-order SNUR” construction to regulate new chemicals without an order -- was somewhat predictable.  This construction, since its inception, has led to questions about whether this interpretation meets the requirements under TSCA Section 5.  In our view, EPA issuing a SNUR to prohibit conditions of use that EPA identifies as potentially leading to an unreasonable risk was an appropriate and expeditious means to achieve the protective end (the TSCA regulation) without the inefficiency and delays associated with the development of a consent order.  EPA would only use this option when EPA concluded the intended conditions of use were not likely to present an unreasonable risk.  It is not clear why a SNUR is viewed as being less protective than an order, when an order applies only to the premanufacture notice (PMN) submitter and a SNUR applies to all actors in the supply chain.  EPA is required to promulgate a SNUR that conforms to an order absent a reason otherwise.  The claim that undertaking a condition of use that is defined in a SNUR as a significant new use “requires only notification to EPA” misrepresents the rigor of the significant new use notice (SNUN) process.  A SNUN functions just like a PMN, with a similar level of effort required on the submitter’s and EPA’s parts and nearly identical determination outcomes (a consent order, modification of the existing SNUR, or revocation of the existing SNUR if warranted), so saying that a SNUN is “just a notification to EPA” is the equivalent of stating that a PMN is “just a notification to EPA.”  Detractors might also claim that orders include testing, but that presumes that testing is required for EPA to make an informed decision.  If EPA can, as it routinely does, make a decision based on conservative assumptions with analogs, models, and information provided by the submitter, EPA can similarly make an informed decision about what measures are necessary to achieve its protective goal without new test data.  In Bergeson & Campbell, P.C.’s (B&C®) view, this policy change will add marginal, if any, protective benefit at a significant increase in effort by both EPA and the submitter.

EPA’s decision that it no longer views use of PPE as reasonably foreseeable is an unwelcome and unprincipled development.  B&C, on behalf of the TSCA New Chemicals Coalition (NCC), provided, at OPPT’s request, a robust data set that demonstrated that proper PPE is rarely not used in an industrial/commercial setting.  A database of 40 years of OSHA violations contained very few glove, goggle, and general dermal protection violations -- all obvious violations to any inspector.  The marginal number of OSHA violations supports the NCC’s view that standard PPE use is both reasonably foreseeable and highly likely and demonstrably so.  Today’s unexplained reversal is difficult to reconcile with these facts.  If EPA proceeds to issue orders for every PMN that may present a risk if workers do not take routine protective measures, then EPA will be required to regulate nearly every PMN in which EPA identifies a hazard other than “low hazard” for health and ecotoxicity, as was EPA’s practice when the Lautenberg amendments were passed in 2016.  As we have stated previously, that would mean that EPA will be implementing TSCA as a hazard-based law, instead of the clear risk-based law that it is.


 

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our March 9, 2021, blog item, the U.S. Environmental Protection Agency (EPA) announced on March 8, 2021, that “in accordance with Biden-Harris Administration executive orders and directives,” it is asking for additional public input on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, under the Toxic Substances Control Act (TSCA).  On March 16, 2021, EPA announced that comments on the final rules are due May 17, 202186 Fed. Reg. 14398.  EPA seeks comment on:

  • Whether the rules sufficiently reduce exposure to these chemicals, including exposures to potentially exposed or susceptible subpopulations and the environment;
  • Newly raised compliance issues associated with the final rule on phenol, isopropylated phosphate (3:1) (PIP (3:1)), including the compliance dates for certain regulated articles; and
  • Whether to consider additional or alternative measures or approaches.

EPA will use the feedback received during the comment period to determine the best path forward, which could include amending the final rules to include additional or alternative exposure reduction measures or extending compliance dates for certain regulated products and articles.


 
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