USA Regulatory News

The U.S. Environmental Protection Agency (EPA) on October 26, 2023, unveiled a comprehensive plan to improve the assessment of pesticides to quickly and effectively assess potential endocrine-disrupti...

The U.S. Environmental Protection Agency (EPA) on October 26, 2023, unveiled a comprehensive plan to improve the assessment of pesticides to quickly and effectively assess potential endocrine-disrupting effects in humans. This initiative will strengthen the Agency's ability to safeguard against such effects when making pesticide-related decisions under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and to implement the Endocrine Disruptor Screening Program (EDSP) under Section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA).

Understanding Endocrine Systems and Disruptors

Endocrine systems, which regulate hormones in various living organisms, play a central role in processes ranging from development and reproduction to metabolism. Endocrine disruptors are chemicals that interfere with the natural functions of hormones. EPA established the EDSP in 1996 to evaluate how pesticides and other chemicals might affect the estrogen, androgen, and thyroid systems. However, challenges have hampered its effective implementation. EPA lacked efficient methods to rapidly test numerous chemicals for endocrine-disrupting effects and often did not provide clear explanations for collecting the necessary endocrine data.

The Path Forward

EPA's strategic plan involves using its FIFRA process to collect human health endocrine data to improve the efficiency of endocrine-related decision-making. The Agency will prioritize around 400 conventional pesticide active ingredients that are either being registered for the first time or are under registration review. In cases where existing data align with the findings of the FFDCA EDSP, EPA will use this information to expedite decisions and reduce the need for additional testing.

EPA is releasing a scientific paper to clarify which existing data can be used to support endocrine disruption findings. For 403 conventional pesticides, EPA has established sufficient estrogen and androgen data for 86 chemicals to make EDSP decisions regarding their potential effects on human systems. Additionally, 52 pesticide chemicals are now part of this plan, and EPA is communicating its final EDSP decisions regarding their potential effects on the human endocrine system.

Remaining Challenges

As the science on the human endocrine system, especially the thyroid, continues to evolve, EPA anticipates seeking scientific peer review in 2025 to assess advances and its current approach to thyroid assessments.

In the short term, EPA has identified 30 high-priority pesticides that require additional data on potential human estrogen and androgen effects. Preliminary data suggest that these pesticides may affect the endocrine system. The Agency is inviting the public to submit data or comments on these chemicals during a 60-day public comment period. To fill the remaining data gaps, EPA intends to issue FIFRA human health data requests for these pesticides in the spring of 2024. For a second group of 126 conventional pesticides with limited endocrine data, the Agency is seeking information to evaluate their endocrine data needs. Moreover, EPA will determine which of the 161 additional conventional pesticides will require updated endocrine data in the coming years during the registration review process.

The public comment period for this initiative opened on Friday October 27, and stakeholders are encouraged to submit their contributions via Docket EPA-HQ-OPP-2023-0474 at www.regulations.gov.

On October 19, 2023, the U.S. Environmental Protection Agency (EPA) introduced a new rule aimed at improving the evaluation of chemical risks under the Toxic Substances Control Act (TSCA). This propos...

On October 19, 2023, the U.S. Environmental Protection Agency (EPA) introduced a new rule aimed at improving the evaluation of chemical risks under the Toxic Substances Control Act (TSCA). This proposal seeks to align EPA procedures with legal requirements, ensuring comprehensive assessments that safeguard workers and communities.

Key Changes Proposed in the New Rule:

1. Environmental Justice Emphasis: The rule commits to considering disproportionate harms in overburdened communities, including multiple exposure pathways and combined risks from multiple chemicals.
2. Comprehensive Evaluations: Risk evaluations must cover all conditions of use and exposure pathways.
3. Worker Protection: Clear provisions to ensure that risks to workers are properly assessed.
4. Scientific Rigor: EPA will use the best available science for evaluations and base decisions on scientific evidence.
5. Unified Determination: Risk evaluations will culminate in a single determination of unreasonable risk; not individual chemical uses.
6. Transparency and Procedural Requirements: New requirements for transparent risk evaluation document revisions.
7. Adjusted Manufacturer Requested Evaluations: Aligns the process with EPA-initiated evaluations and data collection.

These changes, previously announced in 2021, aim to provide certainty and predictability for EPA and stakeholders. Public comments on the proposed rule will be accepted for 45 days at docket EPA-HQ-OPPT-2023-0496 on www.regulations.gov. This proactive approach is part of a broader effort to ensure the safety of chemical substances and protect the environment and public health.

Background: The Three-Step Process

EPA's risk evaluation process for existing chemicals under TSCA is a structured, three-step procedure that begins with Prioritization, followed by Risk Evaluation, and concludes with Risk Management. The primary objective of the Risk Evaluation step is to determine whether a chemical substance poses an unreasonable risk to human health or the environment under its specific conditions of use.

During this evaluation, several key principles guide the assessment:

1. Hazard and Exposure Assessment: EPA examines both the hazards associated with the chemical, which may include factors such as toxicity and the extent of exposure. This approach disregards non-risk-related factors and ensures that scientific methods align with the best available science and a weight-of-scientific-evidence basis.
2. Initiation of the Risk Evaluation: Risk evaluations can be initiated by the EPA either through the Prioritization process or by accepting a manufacturer's request.
   • EPA-Initiated Risk Evaluations: The EPA, pursuant to the Lautenberg Act, initiated evaluations for the first 10 chemicals in December 2016, chosen from the 2014 Update to the TSCA Work Plan. Subsequently, EPA continues to conduct evaluations on High-Priority Substances designated through the Prioritization process.
3. Components of a Risk Evaluation: The risk evaluation process comprises several key components:
   • Scope of the Risk Evaluation: A draft scope is published in the Federal Register within three months of initiating the risk evaluation, followed by a 45-day public comment period. A final scope is published no later than six months after the evaluation's initiation, as required by law.
   • Hazard Assessment: EPA identifies the adverse health or environmental effects of exposure to the chemical, encompassing areas like cancer, mutation, reproductive, developmental, and respiratory impacts.
   • Exposure Assessment: This phase delves into the extent and nature of exposure under various conditions of use, as well as the populations exposed.
   • Risk Characterization: EPA integrates available information regarding hazards and exposure, including assessments of information quality and alternative interpretations.
   • Risk Determination: EPA produces a draft determination regarding whether the chemical poses an unreasonable risk to health or the environment.
4. Publication of the Risk Evaluation: The final risk evaluation is released within 3 to 3.5 years after identifying the chemical as a high priority for risk assessment.

Find the docket numbers, problem formulations, scope documents and supplemental documents for each chemical substance undergoing risk evaluation under TSCA here.

On October 23, 2023, the U.S. Environmental Protection Agency (EPA) unveiled a major proposal aimed at prohibiting the use of trichloroethylene (TCE), an exceptionally dangerous chemical known to be a...

On October 23, 2023, the U.S. Environmental Protection Agency (EPA) unveiled a major proposal aimed at prohibiting the use of trichloroethylene (TCE), an exceptionally dangerous chemical known to be associated with serious health risks, including cancer, neurotoxicity, and reproductive toxicity.

Background-

Trichloroethylene (TCE) is a substance found in various cleaning and furniture maintenance products, degreasers, brake cleaners, and tyre repair sealants. Several safer alternatives are readily available for most of these consumer applications. Commercially, TCE is used in vapor degreasing of components such as aircraft parts and machinery, as an intermediate in the production of specific refrigerants (which are already being phased out in the US), and in the production of battery separators for electric vehicles, transportation, security, and defense systems.

For decades, TCE contamination has plagued numerous communities, causing adverse health effects. This harmful substance is often found as a contaminant in soil and groundwater at Superfund sites. EPA has been actively involved in cleanup efforts, but the regulations proposed today, as part of the revamped 2016 Toxic Substances Control Act (TSCA), would potentially have spared many communities from the harmful effects of TCE exposure.

EPA's research has identified TCE as a causative agent of liver cancer, kidney cancer, and non-Hodgkin’s lymphoma. Moreover, TCE adversely affects the central nervous system, liver, kidneys, immune system, reproductive organs, and poses a threat to fetal development, even at minute concentrations. People residing near TCE production and use facilities face an elevated risk of developing these health conditions.

Proposal-

Under the Toxic Substances Control Act (TSCA), this initiative seeks to protect the public by prohibiting the manufacture, processing, and distribution of TCE for all uses. The proposed risk management rule will take effect within one year for consumer products and most commercial uses. It will also enforce strong protections for workers in the limited remaining commercial and industrial applications, with a longer phase-down period.

The anticipated reductions in exposure from this proposal aim to prevent cancer before it takes root, in line with President Biden’s Cancer Moonshot initiative.

Details of the Proposal-

EPA's proposed risk management rule would restrict most uses of TCE within a year, including its manufacture and processing for most commercial and consumer products. During this period, most individuals at risk of exposure to TCE such as workers in various sectors, consumers, and communities, will benefit from the protections in place. Safer alternatives are already available for most uses of TCE as a solvent

For limited uses of TCE, such as critical uses by federal agencies, the production of battery separators for electric vehicle batteries, and the manufacturing of specific refrigerants that are subject to national phase-down in favor of environmentally friendly alternatives, the proposal will grant an extended transition period. Strict worker protection measures will be mandated to minimize near-term exposures.

Furthermore, EPA's proposal includes provisions for essential laboratory use and proper disposal of TCE wastewater at sites with historic TCE contamination, extending up to 50 years, subject to workplace safety protocols.

The EPA is inviting public input on this proposed TCE rule for 45 days following its publication in the Federal Register via docket EPA-HQ-OPPT-2020-0642 at www.regulations.gov. The Agency also plans to conduct a public webinar for employers and workers to provide insight into the proposed regulatory measures.

This initiative represents a significant step towards safeguarding public health and promoting a cleaner, safer environment for all.

On August 17, 2023, the first set of data collected under the fifth Unregulated Contaminant Monitoring Rule (UCMR 5) was released by the US Environmental Protection Agency (EPA). As part of the most r...

On August 17, 2023, the first set of data collected under the fifth Unregulated Contaminant Monitoring Rule (UCMR 5) was released by the US Environmental Protection Agency (EPA). As part of the most recent effort to implement EPA's PFAS Strategic Roadmap, UCMR 5 will provide new data that will improve EPA's understanding of the prevalence of 29 per- and polyfluorinated substances (PFASs) and lithium in the United States drinking water systems. The Agency will use the lithium and PFAS monitoring data to make decisions about how best to implement the public health protection measures of the Safe Drinking Water Act (SDWA) in the future. The Administration is committed to stopping PFAS pollution and protecting drinking water for all people. 

Unregulated Contaminant Monitoring Rule  

The UCMR 5 data will help EPA make better science-based decisions and help EPA find out how much of these 29 PFAs and lithium people are being exposed to at the national level, and whether they are disproportionately affecting people with environmental justice issues.  The first batch of data represents about 7% of the total results EPA expects to get over the next 3 years. 

The Agency will make the results available to the public on a quarterly basis in  EPA’s National Contaminant Occurrence Database (NCOD) until the data reporting ends in 2026. EPA continues to look for new ways to measure these and other contaminants and at lower levels. 

PFAS, or ‘forever chemicals’, pose significant risks to public health. The EPA is implementing an extensive monitoring program to address these harmful chemicals, monitoring them in all large and medium-sized public water systems in the United States. 

EPA has proposed regulations in March 2023 to limit the presence of certain PFAS in drinking water, which would allow public water systems to use UCMR 5 findings to meet their initial monitoring obligations and alert communities to potential remedial actions. EPA has established Health Advisories for four of the PFASs included in UCMR 5. The science behind the potential health effects of a variety of PFASs, including many of those tested under this program, is still being developed by EPA. 

Safe Drinking Water Act 

The Safe Drinking Water Act (SDWA) requires EPA to monitor for priority contaminants every five years. Priority contaminants are those that may be present in drinking water but are not yet subject to EPA drinking water regulations. EPA uses the Unregulated Contaminant Monitoring Rule (UCMR) to provide the Agency and other interested parties with nationally representative information on the presence of contaminants in drinking water. This data includes the magnitude of potential exposure to the public as well as estimates of exposure levels. These data can support forthcoming regulatory decisions, the development of National Primary Drinking Water Regulations (NPDWRs), and other measures to protect human health. 

The US Environmental Protection Agency (EPA) has opened a 60-day public comment period on the draft Toxicological Review of Inorganic Arsenic under the Integrated Risk Information System (IRIS). This ...

The US Environmental Protection Agency (EPA) has opened a 60-day public comment period on the draft Toxicological Review of Inorganic Arsenic under the Integrated Risk Information System (IRIS). This draft, prepared by the Center for Public Health and Environmental Assessment (CPHEA) within EPA's Office of Research and Development, evaluates the toxicological effects of inorganic arsenic. The public comment period, which opened on October 16, 2023, will remain open until December 15, 2023.

BACKGROUND:

Inorganic arsenic is used in various industrial applications, including the hardening of copper and lead alloys, glass manufacture, and as a catalyst in the production of ethylene oxide. Given its widespread use, understanding its potential health risks is of paramount importance. The draft IRIS assessment, if finalized, could lead to stricter federal regulations on the use of inorganic arsenic in these industries.

KEY ASPECTS:

The latest evaluation introduces an overall reference dose of 0.031 µg/kg per day, which is well-supported by evidence that links inorganic arsenic to circulatory system disorders. The potential adoption of this reference dose has significant implications for the regulation of inorganic arsenic in various products and processes. While the EPA's Integrated Risk Information System program previously classified arsenic as carcinogenic, this classification remains unaltered in the latest draft.

However, the draft assessment looks more closely at the risks beyond cancer, including new data on noncancerous effects. These include effects on the cardiovascular system, neurodevelopment, pregnancy, and diabetes. The draft assessment conveys a high level of confidence in the role of inorganic arsenic compounds in the development of cardiovascular disease and diabetes, and a moderate level of confidence in their association with pregnancy, birth, and neurodevelopmental effects.

This comprehensive evaluation of the health effects of inorganic arsenic underscores the critical importance of regulating the use of this compound in various industries. To participate in the public comment process and have your say on these proposed regulations, visit the IRIS website or the public docket, with Docket ID No. EPA–HQ–ORD–2012–0830. The EPA welcomes input from stakeholders, scientists, and the public to help shape the future regulation of inorganic arsenic.

PFDA Review

The EPA also published a report detailing an external peer review of its preliminary IRIS assessment of perfluorodecanoic acid (PFDA), a long-chain PFAS. The reviewers generally agreed with the EPA's initial findings on the effects of PFDA on the immune system and development, but also provided additional perspectives. In the preliminary draft, a provisional overall reference dose of 4*10-10 mg/kg/day was established, based on considerations of immunotoxicity and developmental toxicity. However, the report underscores that the information currently available is insufficient for a comprehensive evaluation of the risks associated with PFDA.

On September 29, 2023, the U.S. Environmental Protection Agency (EPA) expanded the Safer Chemical Ingredients List (SCIL) by adding ten chemicals. The SCIL is a dynamic compilation of chemicals that m...

On September 29, 2023, the U.S. Environmental Protection Agency (EPA) expanded the Safer Chemical Ingredients List (SCIL) by adding ten chemicals. The SCIL is a dynamic compilation of chemicals that meet the safety criteria of the Safer Choice program and now includes 1,071 chemicals that are considered the safest for their intended purposes.

Background

The Safer Chemical Ingredients List (SCIL) is a comprehensive compilation of chemical ingredients classified according to functional-use categories. These ingredients have been assessed by the Safer Choice Program and have been deemed to be safer alternatives to conventional chemical ingredients. The primary objective of this list is to assist manufacturers in identifying and adopting chemical alternatives that meet the exacting standards of the Safer Choice Program.

Selection Criteria

Prior to the inclusion of a chemical on the Safer Chemical Ingredients List (SCIL) by the Safer Choice program, an independent third-party profiler, such as NSF International, or ToxServices, is responsible for collecting hazard information. This process involves a comprehensive examination and assessment of all available data on the chemical's toxicological properties and environmental behavior. Subsequently, the third-party profiler compiles a detailed report for submission to Safer Choice, together with a recommendation as to whether the chemical meets the criteria for Safer Chemical Ingredients. Additionally, Safer Choice may conduct supplementary literature reviews and consider data from confidential sources, such as the Environmental Protection Agency's New Chemicals Program.

The Safer Choice program certifies products containing ingredients that meet the program’s criteria for human health and environmental safety and allows companies to use its label on products that meet the Safer Choice Standard. EPA encourages manufacturers to submit their safer chemical formulations for EPA evaluation and potential listing on the SCIL, which the EPA revises at least once annually to reflect advances in the field of safer chemistry.

The latest additions to the SCIL are: 

• Fats and Glyceridic oils, vegetable, hydrogenated; 
• Tocopherols; 
• Sulfuric acid, dimethyl ester, compd. with .alpha.,.alpha.',.alpha.'',.alpha.'''-[1,6-hexanediylbis(nitrilodi-2,1-ethanediyl)]tetrakis[.omega.-hydroxypoly(oxy-1,2-ethanediyl)]; 
• Glycolipids, sophorose-contg., Candida bombicola-fermented, from D-glucose and mahua Madhuca longifolia fats and glyceridic oils; 
• 1,4-Benzenedicarboxylic acid, 1,4-dimethyl ester, polymer with 1,2-ethanediol, .alpha.-hydro-.omega.-hydroxypoly(oxy-1,2-ethanediyl) and 1,2-propanediol, ester with .alpha.-methyl-.omega.-hydroxypoly(oxy-1,2-ethanediyl); 
• Dodecanoic acid, ester with 1,2-propanediol; 
• Diisopropyl succinate; 
• Diisopropyl sebacate;  
• Methyl propanediol; and 
• Methyl ethyl ketone. 

You can access a downloadable spreadsheet of the Safer Chemical Ingredients List (xls). Additionally, the U.S. EPA has initiated efforts to eliminate per- and polyfluoroalkyl substances from the program and to explore the possibility of expanding the scope of the program to include categories that are presently outside its scope.

On 28 September 2023 the U.S. Environmental Protection Agency (EPA) finalised a rule that will result in the most comprehensive collection of data on per- and polyfluoroalkyl substances (PFAS) produce...

On 28 September 2023 the U.S. Environmental Protection Agency (EPA) finalised a rule that will result in the most comprehensive collection of data on per- and polyfluoroalkyl substances (PFAS) produced and used in the United States. This rule is the culmination of more than two years of progress on the Government's initiative to tackle PFAS pollution, protect public health, and promote environmental justice, and is a major step in the EPA's PFAS Strategic Roadmap.

Per- and Polyfluorinated Substances

Per- and Polyfluorinated Substances (PFAS) are a class of manufactured chemicals that are widely used in industrial and consumer products. They have been manufactured since the 1940s and have properties that allow them to be used in a wide range of products, from non-stick cookware to waterproof clothing and firefighting foam. They are also used in some manufacturing processes.

PFAS are known as 'forever chemicals' as they are extremely persistent in our environment and bodies. They can lead to health problems such as liver damage, thyroid disease, obesity, fertility issues and cancer.

EPA’s Final Rule

The final rule expands the scope of the proposed rules definition of PFAS to include 41 additional PFAS identified as being of concern. The Environmental Protection Agency (EPA) has determined that a minimum of 1,462 PFAS have been produced or manufactured in the United States since 2011 will be subject to the final rule. It is important data to protect human health and the environment from these chemicals.

The Toxic Substance Control Act (TSCA) reporting rule is part of the FY2020 National Défense Authorization Act (NDAA), which requires all manufacturers (including importers) of PFAS-containing products in a given year from 2011 to submit information to the Environmental Protection Agency (EPA) including chemical identity, volume of products manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal.

This rule will provide the ability to understand and effectively protect people from PFAS and to conduct research on who is using the substances and in which quantity.  This rule will produce actionable data that can be used by the EPA and governments to craft policies and laws to protect people and the environment from PFAS.

Timeline

Companies will have 18 months from the effective date of the final rule (30 days after publication in the Federal Register) to report data online. Small companies that only report data on the import of PFAS in articles will have an additional 6 months to complete their online submissions.