EPA final rule sets reporting requirements for 50 chemicals

First published by Safety+Health an NSC publication

Washington — The Environmental Protection Agency has issued a final rule that requires anyone who manufactures or imports 50 specified chemicals to report to the agency “certain lists and copies of unpublished health and safety studies” undertaken within the past decade.

This action is being taken, according to EPA, because the Interagency Testing Committee – established under the Toxic Substances Control Act of 1976 – has added the substances to its Priority Testing List. The chemical substances subject to the rule include 20 chemicals EPA has designated as high-priority substances for risk evaluation under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, as well as 30 organohalogen flame retardants the Consumer Product Safety Commission is evaluating for risks under the Federal Hazardous Substances Act of 1960.

Under the rule, published in the June 29 Federal Register and slated to go into effect July 29, manufacturers and importers must submit:

  • Lists and copies of unpublished health and safety studies on health effects, such as toxicity studies on carcinogenicity, reproductive and developmental effects, genotoxicity, neurotoxicity, immunotoxicity, and endocrine effects
  • All unpublished studies on environmental effects, environmental fate and physical chemical properties if performed as described in 40 CFR 716.50
  • All unpublished studies on occupational (both users and nonusers), general population, consumer and environmental exposure
  • Studies showing any measurable content of the specified chemical in the tested substance, whether single substances or a mixture; the composition and purity of test substances must be reported if included as part of the study

Additionally, the rule is applicable to anyone who intends to manufacture or import the specified chemicals within 90 days of the EPA notice.

The 20 high-priority chemicals are separate from the first 10 chemicals being evaluated for potential health and environmental risks under the Lautenberg Act. The former group of chemicals includes:

  • Seven chlorinated solvents
  • Six phthalates, or hormone-disrupting substances, linked to several health issues
  • Four flame retardants
  • Formaldehyde
  • One fragrance additive
  • One polymer precursor

Requests to withdraw chemical substances from the final rule are due July 13. The requested information is due Sept. 27.


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EPA publishes final risk evaluation for methylene chloride

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Photo: California Department of Public Health

Washington — Methylene chloride poses “unreasonable risk” to workers under certain conditions, according to a final risk evaluation recently released by the Environmental Protection Agency, which now is compelled to propose within one year regulatory action to mitigate the chemical’s hazards.

Frequently used for bathtub refinishing, methylene chloride is among the first 10 chemicals under evaluation for potential health and environmental risks under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. In 2014, EPA found that exposure to the chemical may cause cancer, harm to the central nervous system and toxicity to the liver, among other adverse health effects.

The final evaluation, published June 19, is the first to be released for the 10 chemicals. Announced via a notice published in the June 24 Federal Register, the document states methylene chloride poses unreasonable risk to workers involved in numerous operations, including:

  • Plastic and rubber manufacturing
  • Electrical equipment, appliance and component manufacturing
  • Oil and gas drilling, extraction and support activities
  • Adhesive/caulk removal
  • Cold pipe insulation
  • Aerosol and non-aerosol degreasing and cleaning

Additionally, EPA determined an unreasonable risk is not present during the following conditions of use:

  • Domestic manufacture
  • Processing as a reactant
  • Recycling
  • Distribution in commerce
  • Industrial and commercial use as a laboratory chemical
  • Disposal

As required under the Toxic Substances Control Act, which the Lautenberg Act amended, EPA must address risks by proposing within one year regulatory actions such as training, certification, restricted access, and/or ban of commercial use, and then accept public comment on any proposals.

“Releasing the first final risk evaluation marks a key milestone in our efforts to fulfill our responsibilities for ensuring the safety of chemicals already on the market,” Alexandra Dapolito Dunn, assistant administrator of the EPA Office of Chemical Safety and Pollution, said in a June 19 press release. “By following the TSCA process, we can have confidence in our final conclusions and move forward with developing a plan to protect the public from any unreasonable risks.”

In March 2019, EPA published a final rule that prohibits manufacture (including import), processing and distribution of the substance in paint removers for consumer use, as well as requires manufacturers, processors and distributors to notify retailers and others in the supply chain about the ban.

EPA Administrator Andrew Wheeler said in the release that the action “builds on last year’s ban on consumer sales of certain methylene chloride products and will guide the agency’s efforts to further reduce risks from this chemical.”

Liz Hitchcock, director of the Washington-based advocacy group Safer Chemicals, Healthy Families, called on the agency to expedite its regulatory actions, contending in a June 19 statement that “the longer EPA drags its feet, the more lives will be lost.” According to Safer Chemicals, Healthy Families, at least 64 people have died from acute exposure to methylene chloride since 1980.

“The time for study and talk is long past,” Hitchcock’s statement reads. “EPA should take immediate action on the danger it has once again recognized in this risk evaluation and finish the job to protect workers. The agency must immediately finalize its proposed ban on commercial use of these products. To wait any longer to protect workers from these dangerous products when EPA has the ability to ban them now is unconscionable and will result in more preventable deaths.”

In April 2019, Safer Chemicals, Healthy Families was part of a coalition of groups representing worker rights that filed a lawsuit against EPA and Wheeler for excluding workers in the final rule.

EPA previously solicited comments on problem formation documents for the first 10 chemicals before releasing its first draft risk evaluation – for Pigment Violet 29 – in November 2018. The agency released its draft risk evaluation for methylene chloride in October.

EPA says it plans to release final risk evaluations for the remaining nine of the first 10 chemicals by the end of the year.

Preparing chemical facilities for extreme weather events: CSB releases safety alert, video

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Photo: Chemical Safety Board

Washington — The Chemical Safety Board has published a safety alert and video intended to help hazardous chemical facilities prepare for hurricanes and other extreme weather events.

Announced in a June 23 press release, the safety alert and five-minute video include highlights from a Center for Chemical Process Safety guidance document. Assessment of and Planning for Natural Hazards, published in October, was developed after CSB’s investigation into an August 2017 incident at an Arkema Inc. chemical plant in Crosby, TX.

After flooding from Hurricane Harvey caused an evacuation of the facility, organic peroxide products stored inside a formerly refrigerated trailer decomposed and caught fire, releasing dangerous fumes and smoke into the air. Officials initially chose to keep a nearby highway open and, as a result, 21 people needed medical attention for exposure to hazardous fumes. More than 200 residents living nearby were later evacuated and could not return home for a week.

CSB found “a significant lack of industry guidance on planning for flooding or other severe weather events” despite an increase in flooding throughout the United States in recent years.

“Some experts predict this trend will continue,” CSB Chair and CEO Katherine Lemos says in the video. “The incident at Arkema is not an anomaly.

“When analyzing safety hazards at a facility, companies are not specifically required to consider the risks of extreme weather. For this reason, I’m concerned that other companies may not be aware of the potential for flooding to create process safety hazards.”