The Toxic Substances Control Act (TSCA) was enacted in 1976 and provides the Environmental Protection Agency (EPA) with “authority to require reporting, recordkeeping and testing requirements, and restrictions relating to chemical substances and/or mixtures. Certain substances are generally excluded from TSCA, including, among others, food, drugs, cosmetics and pesticides”.1

TSCA provides EPA with the authority to regulate entities – including distributors; manufacturers (including importers) and processors (e.g., formulators); commercial users (workplaces and workers); and entities disposing of chemicals for commercial purposes.

Background/History

Under TSCA, EPA has authority to regulate at the manufacturing, processing and distribution levels in the supply chain to eliminate or restrict the availability of chemicals and chemical-containing products for consumer use. These authorities allow EPA to regulate at key points in the supply chain to effectively address unreasonable risks to consumers. However, EPA cannot directly regulate consumer users. 2

In June 2016, Congress amended TSCA with the Frank R. Lautenberg Chemical Safety for the 21st Century Act. This law required EPA to evaluate and address unreasonable risks from chemicals currently in commerce to protect the public while outlining a predictable and comprehensive path for the regulated community. Later that year, methylene chloride, along with nine other chemicals, was identified for risk evaluation. These chemicals are commonly referred to as the “First 10”; and methylene chloride was the first of those to publish a proposed rulemaking under TSCA – with EPA determining that it presents an unreasonable risk under its conditions of use. 2

In March 2019, EPA issued a final rule to prohibit the manufacture (including import), processing, and distribution of methylene chloride for consumer paint and coating removal – requiring manufacturers, processors, and distributors to notify retailers and others in their supply chains of the prohibitions and to maintain records.1

To further protect human health, on July 8, 2024, EPA issued a new rule for methylene chloride 3, expanding workplace protections under TSCA that would:

• Prohibit the manufacturing (including import), processing, and distribution in commerce of methylene chloride for all consumer use and most industrial and commercial uses.
• Require a Workplace Chemical Protection Program (WCPP) for 13 methylene chloride conditions of use.
• Identify a de minimis threshold of 0.1% for products containing methylene chloride for the prohibitions and restrictions on methylene chloride.
• Require recordkeeping and downstream notification requirements for manufacturing (including import), processing, and distribution in commerce of methylene chloride.
• Provide a 10-year time-limited exemption under TSCA section 6(g) for emergency use of methylene chloride in furtherance of the National Aeronautics and Space Administration’s (NASA) mission. 3

Why Methylene Chloride?

Methylene chloride is an acutely lethal neurotoxicant, and chronic exposure can affect liver function and cause cancer. According to a 35-year study published by EPA in June 2021, acute methylene chloride exposure resulted in at least 85 occupational deaths in the U.S. between 1985-2018 – with the most recent in June 2020. EPA found that unreasonable risk from methylene chloride is driven by risks to workers, consumers, and bystanders for 52 of the 53 conditions of use. 3 [TSCA defines “condition of use” as “the circumstances…under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used or disposed of”.]

EPA’s Workplace Chemical Protection Program

EPA determined that the WCPP will protect people from unreasonable risk posed by occupational exposures from certain conditions of use and that workers are one of the potentially exposed or susceptible subpopulations (PESS) under TSCA. EPA consulted with the Occupational Safety & Health Administration (OSHA) and the National Institute for Occupational Safety & Health (NIOSH), who coordinated on WCPP development and aligned
requirements where possible.

According to the EPA, multiple factors were considered in deciding risk management for industrial and commercial conditions of use. Uncertainty regarding ability to comply with an exposure limit or preventing direct dermal contact can influence whether a condition of use is considered to be a candidate for WCPP or whether prohibition is more appropriate.4 Requirements of a methylene chloride WCPP – and key compliance dates, as appropriate –include:

• Exposure limits – Inhalation exposure limits of methylene chloride, called the EPA existing chemical exposure limit (ECEL) and EPA short term exposure limit (EPA STEL) must be met by August 1, 2025. [The ECEL is two parts per million (ppm), or 8 mg/m3, as an eight-hour time-weighted average (TWA); the EPA STEL is 16 ppm, or 57 mg/m3, as a 15-minute TWA.]
• Initial and periodic exposure monitoring – Workplace air concentrations of methylene chloride must be determined through personal breathing zone samples by May 5, 2025.
• Establishment of a regulated area – Owner/operator must mark areas where airborne concentrations of methylene chloride exceed, or there is a reasonable possibility they may exceed, the inhalation exposure limits.
• Development and communication of an exposure control plan – with the following components completed by October 30, 2025:
  • Identification of exposure controls
  • Description of exposure control implementation,
  • Description of the regulated area(s) and authorized entry
  • Description of measures to ensure effective controls
  • Procedures for responding to any potential changes that may introduce additional methylene chloride exposure
• Respirator selection criteria – If respiratory protection is needed, supplied-air respirators must be used for methylene chloride. This rule does NOT permit the use of air-purifying respirators due to the short service life of chemical cartridges when used for methylene chloride exposure.
• Recordkeeping and downstream notification – This includes recordkeeping and notification to persons potentially exposed to methylene chloride of the results of workplace exposure monitoring activities, exposure incidents, and the steps taken or to be taken to protect them from exposure.5

According to EPA, the methylene chloride WCPP applies to Owners or Operators and Potentially Exposed Persons which is a broader definition than “employers”.3

Conclusion

Under the final rule, EPA’s regulation of methylene chloride is far-reaching and includes a significant impact on regulating the workplace. The new regulation provides lower exposure limits and stricter monitoring of the workplace for those commercial uses that will not be “banned”. The rule also puts into place the prohibition of many uses of methylene chloride effective July 8, 2024.

Additional Resources from HETI

HETI’s industrial hygiene and safety professionals are available to assist clients with a variety of services to help develop and implement a Methylene Chloride Workplace Chemical Protection Program in accordance with the new TSCA rule. Whether the need is for written programs and/or industrial hygiene assessments, we are here to help.

For further information on HETI’s environmental health & safety services, please contact us.

Mark Ostapczuk, CIH, CSP
Director – Life Sciences Practice

Phone: 978.263.4044
development@hetiservices.com

Resources:

1Risk Management for Methylene Chloride | US EPA
2Summary of the Toxic Substances Control Act | US EPA
3The Methylene Chloride Rule | US EPA
4U.S. EPA Webinar on Proposed Regulation of Methylene Chloride under the Toxic Substance Control Act (TSCA)
5A Guide To Complying with the 2024 Methylene Chloride Regulation under the Toxic Substances Control Act (TSCA)
[RIN 2070-AK70, mecl-compliance-guide.pdf (epa.gov)]

Effective training is a cornerstone of this mission: providing workers with the knowledge and skills to perform their jobs safely and to understand the hazards they might face. In this edition of HETI Horizons, we will explore the key aspects of the Occupational Safety & Health Administration (OSHA) training requirements – including who needs training, what topics are covered, and how training should be conducted and documented.
OSHA continuously updates and refines its training requirements to address emerging workplace hazards and improve safety standards. Here are some of the recent updates and trends in those requirements:

• OSHA introduced Emergency Temporary Standards to address the COVID-19 pandemic, particularly focusing on healthcare settings. These standards require employers to implement a COVID-19 plan, screen employees, and provide proper personal protective equipment (PPE) and training on infection control practices.
•  OSHA has been focusing on workplace violence, particularly in healthcare and social services. The agency is considering new standards that would require employers to develop and implement violence prevention plans, including training for workers on recognizing and de-escalating potentially violent situations.
• OSHA refers to the NFPA 70 Standard for electrical safety in the workplace. Recent updates to this standard require more comprehensive training on electrical safety practices, arc flash hazards, and the proper use of electrical PPE.

Who Needs OSHA Training?

OSHA training requirements are designed to cover a wide range of industries and job
functions. Virtually every worker in the United States could benefit from some form of OSHA
training, but specific requirements vary depending on the nature of the job and the
associated risks. Key groups that typically require OSHA training include:

• General Industry Workers: This broad category includes workers in sectors such as
  manufacturing, healthcare, and warehousing. OSHA’s General Industry Standards (29 CFR 1910) specify the training needed for various hazards these workers might encounter.
• Construction Workers: Given the high-risk nature of construction work, OSHA has developed specific standards (29 CFR 1926) that mandate training on hazards unique to this field – such as fall protection, scaffolding, and trenching.
• Maritime Workers: Maritime industry workers must be trained according to OSHA’s Maritime Standards (29 CFR 1915, 1917, and 1918), which address risks related to shipyard employment, marine terminals, and longshoring.
• Agricultural Workers: OSHA’s Agriculture Standards (29 CFR 1928) require training for hazards like machinery, pesticides, and grain handling.

What Topics Are Covered?

The topics covered in OSHA training programs are extensive and tailored to the specific hazards of different industries. Some of the key areas include:

• Hazard Communication: Workers must be trained to understand and identify chemical
  hazards, read labels and safety data sheets, and know the procedures for handling hazardous
  substances safely.
• Personal Protective Equipment: Training on the correct selection, use, maintenance, and
  disposal of PPE is crucial to protect workers from physical, chemical, and biological hazards.
  The employer must ensure that each employee can demonstrate knowledge of their respirator’s
  proper fit, usage, or maintenance.
• Emergency Action Plans: Employees must be trained on how to respond to various emergencies – including fires, chemical spills, and natural disasters. This includes evacuation procedures and the use of emergency equipment.
• Lockout/Tagout Procedures: For workers involved in the maintenance and servicing of machinery, training on lockout/tagout procedures is essential to prevent accidental machine start-up and ensure energy sources are safely controlled.
• Fall Protection: In industries such as construction, training on fall protection systems and the correct use of harnesses, guardrails, and nets is vital to prevent fall-related injuries and fatalities.

How Should Training Be Conducted?

Effective OSHA training should be comprehensive, engaging, and tailored to the specific needs of the
workforce. Here are some key principles for conducting training:

• Qualified Trainers: Training should be conducted by individuals who have the necessary knowledge,
  experience, and teaching skills to effectively communicate safety concepts and practices.
• Interactive and Practical: Training sessions should include interactive elements such as hands-on
  demonstrations, real-life scenarios, and practical exercises – to ensure workers can apply what they have learned in their daily tasks.
• Language and Literacy Considerations: To be effective, training must be understandable to all
  workers. This means providing instruction in the workers’ primary languages and considering literacy levels.
• Regular and Ongoing: Initial training should be followed by regular refresher courses to reinforce safety concepts and keep up with any changes in regulations or workplace conditions.

Documentation and Compliance

Proper documentation of OSHA training is essential for demonstrating compliance with regulations and for keeping track of workers’ training history. Key documentation practices include:

• Training Records: Maintain detailed records of all training sessions – including dates, topics covered, trainer information, and participant names.
• Certificates of Completion: Provide certificates or other proof of training completion to employees, which can be useful for compliance verification and employee records.
• Regular Audits: Conduct regular audits of training programs and records to ensure ongoing compliance with OSHA standards and to identify any areas for improvement.

HETI…Here to Help

In conclusion, OSHA training is a vital component of workplace safety – equipping workers with the
knowledge and skills they need to protect themselves and their colleagues from hazards. By adhering to OSHA’s training requirements, employers can create a safer work environment, reduce the risk of accidents and injuries, comply with federal regulations, and demonstrate their ongoing commitment to workplace health and safety.
HETI can help businesses comply with OSHA training requirements, ensure safe workplaces, and avoid costly penalties. By offering customized training programs, employing expert trainers, ensuring
comprehensive compliance documentation, and providing continuous support, HETI serves as an essential partner for businesses aiming to meet regulatory requirements and create safe working environments.

1,4-Dioxane, a highly mobile compound found in various manufacturing processes and consumer products, has drawn significant attention recently. Classified by the United States Environmental Protection Agency (USEPA) as “likely to be carcinogenic to humans” by all routes of exposure, its properties present challenges for characterization and treatment – sparking concerns about its potential impact on human health and the environment.

What is 1,4-Dioxane?

A volatile, flammable liquid, 1,4-dioxane is a man-made organic compound. Its high mobility in soils and rapid migration in groundwater, coupled with its resistance to subsurface biodegradation, pose environmental challenges. While it shares similarities with “forever chemicals” like PFAS, 1,4-dioxane does not bioaccumulate in plants or animals over time, distinguishing it from true “forever chemicals.”

Industrial Applications and Consumer Products

Since the 1950s, 1,4-dioxane has primarily been used as a stabilizer in industrial solvents. While restrictions in drinking water, groundwater, and other environmental regulations have impacted industrial reliance on 1,4-dioxane, it is currently still in use in certain manufacturing processes – including:

• Solvent for paper, cotton, and textile processing
• Chemical manufacturing and stabilizing in chlorinated solvents
• Solvent for paints, dyes, greases, antifreeze, and aircraft deicing fluids
• Pesticide solvent or inert ingredient
• Additive in adhesives
• Solvent in the manufacture of pharmaceuticals, veterinary drugs, and natural health products
• Carrier for biocides; to analyze vegetable matter, dehydrate biological samples prior to slide preparation, and isolate DNA elements
• Byproduct in the manufacture of polyethylene terephthalate (PET) plastic

However, 1,4-dioxane’s presence is not confined to industrial settings. It has been detected as an impurity or trace contaminant in various consumer products – primarily cosmetics and detergents. But many companies have been actively working to reduce this impurity in recent years.

Exposure

The primary exposure pathways for 1,4-dioxane are inhalation, ingestion, and dermal exposure.
Occupational contact and exposure are most likely to occur at manufacturing facilities. People can
be exposed following ingestion or contact with water containing 1,4-dioxane and with cosmetics/
personal hygiene products that contain ingredients in which it may be a contaminant.

Short-term exposure may cause eye, nose, and throat irritation; large quantity short-term exposure may lead to kidney and liver damage. Acute exposure to large amounts of 1,4-dioxane has been associated with adverse nervous system effects and can result in death.

Chronic exposure has shown liver and kidney damage in animals. Laboratory animal studies have also shown that oral exposure over a lifetime causes cancer, while skin exposure can also increase the cancer-causing properties of other chemicals.

Health and Environmental Concerns

Due to its high solubility in water and mobility in soils, one concern associated with 1,4-dioxane is its potential to be a contaminant in groundwater and drinking water. The compound has been identified in water supplies in various regions, leading to worries about its potential effects on public health. Prolonged exposure to elevated levels of 1,4-dioxane in drinking water may pose health risks – making it a subject of close scrutiny by regulatory agencies worldwide. USEPA has set guidelines for acceptable levels in drinking water to ensure public safety.

Regulatory agencies and environmental organizations – such as USEPA, the Occupational Safety & Health Administration (OSHA), and the Food and Drug Administration (FDA) – closely monitor and regulate the levels of 1,4-dioxane in water supplies; work environments; and food, cosmetics, and household products to ensure public safety. In order to limit the inadvertent release of this chemical into the environment, it’s important for industries to implement proper waste disposal practices – including proper wastewater treatment and containment measures to prevent its migration into groundwater.

The Environmental Working Group, the Centers for Disease Control, and the FDA emphasize the importance of raising awareness about 1,4-dioxane and advocating for responsible manufacturing practices. By encouraging the reduction or elimination of this compound in industrial processes, companies can contribute to a healthier and more sustainable environment.

The EPA, OSHA, and other state environmental agencies can also encourage limiting the use of this compound by enforcing more stringent actionable levels in air, water, and soil. For example, USEPA performed a Risk Evaluation in 2020 and drafted a supplement in July 2023 as part of the amended Toxic Substances Control Act (TSCA).

Consumer Awareness and Product Choices

Consumers can also play a crucial role in mitigating the impact of 1,4-dioxane. By being
informed about product ingredients and choosing items with lower or no levels of this compound,
individuals can make choices that align with their health and environmental values. Many
companies are now recognizing the importance of transparency in labeling and are working to
reduce or eliminate 1,4-dioxane from their products.

Treatment Technologies

Since being identified as an emerging contaminant of concern, several technologies have been utilized to remediate 1,4-dioxane with varying results. The removal of 1,4-dioxane by conventional water and wastewater treatment plants has proven to be ineffective due to its unique physicochemical properties. 1,4-dioxane dissolves completely and does not evaporate readily, making it difficult to remove from water.

Wastewater and drinking water treatment plants across the U.S. have needed to implement new techniques to meet the increasingly strict standards as new information about the effects of this compound are discovered. Common treatment technologies include advanced oxidation processes (AOPs) and bioremediation. In situ and ex situ bioremediation processes are being explored as more cost-effective, but time-consuming, remediation techniques.

Ongoing Research and Future Outlook

As the scientific community continues to study 1,4-dioxane, ongoing research aims to deepen our understanding of its behavior in different environments and its potential long-term effects. This knowledge will be instrumental in shaping regulations and industry practices to minimize the risks associated with this compound.

In conclusion, while 1,4-dioxane has widespread industrial applications, its presence in consumer products and potential impact on water supplies have raised valid concerns. Regulatory measures, responsible manufacturing practices, and informed consumer choices are essential in addressing these concerns and working towards a safer, healthier future.

How HETI Can Help

HETI’s staff of environmental scientists, geologists, industrial hygienists and remediation professionals have extensive experience in evaluating sites for potential 1,4-dioxane contamination. We coordinate/conduct soil and groundwater sampling and assess specific needs to bring sites to federal/state regulatory compliance – working with our clients in the development of various remedial approaches. Whatever the issue, HETI is here to help.