Manufacturers Share Chemical Data With EPA to Make Safety Case

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By Pat Rizzuto

The BASF Corp., the Dow Chemical Co. and Honeywell International Inc. are sharing chemical data with the EPA in a bid to persuade agency scientists that the compounds they make or use are safe and should stay on the market.

During the next few years, the Environmental Protection Agency will study and consider regulations for the 10 compounds that are under review if the agency determines they are unsafe—part of the agency’s implementation of last year’s amended toxics law. At stake are hundreds of uses of chemicals in factories, households, and construction sites that hinge on EPA’s upcoming reviews.

Faye Graul, executive director of the Halogenated Solvents Industry Association (HSIA), said industry’s goal for providing information about the 10 chemicals to the EPA is to “to make our case that they should stay on the market.”

Sept. 19 Deadline

In meeting with the EPA, some companies are making the case that certain chemicals are small impurities in the manufacturing process and thus can be safely ignored. Others are providing use and exposure information on major industrial products such as solvents used in manufacturing. Still others are opting not to share data with the EPA, instead waiting to learn more about the process based on this first group of 10 reviews. All have an EPA deadline of Sept. 19 to submit information for this first round of chemical risk reviews.

By the end of the year, the EPA will craft blueprints for studying the health and ecological risks of 10 chemicals that will rely in part on the companies’ use, exposure, and toxicity data they share with the agency. The EPA will augment this data with studies in its own databases, the scientific literature, and other sources. Those 10 blueprints also will include the relevant exposure scenarios, human populations, and environmental conditions of interest.

“While some stakeholders have indicated they may or plan to submit to the docket, they have not necessarily indicated what they would submit,” the EPA told Bloomberg BNA by email. “At this time, EPA has no basis to characterize how much information may be submitted.”

Firms Reach Out

The BASF Corp. is offering hazard and exposure information to support the n-methylpyrrolidone (NMP) and 1,4-dioxane risk evaluations, company spokeswoman Donna Jakubowski told Bloomberg BNA. NMP is a commonly used solvent in industrial and some consumer chemical formulations.

1,4-dioxane is primarily an impurity that occurs during chemical manufacturing, but the chemical also is a processing aid used for wood pulping, pharmaceutical manufacture, and other purposes, the EPA said in a preliminary risk evaluation plan for the chemical.

BASF is submitting some information directly to the EPA and providing data through trade associations, including the American Chemistry Council and the NMP Producers Group, Jakubowski said.

The members of the NMP Producers Group—Ashland Inc., BASF, and Lyondell Chemical Co.—have worked to encourage their customers and other trade associations that represent companies using the solvent to provide the EPA chemical use, exposure, and other data, Kathleen Roberts, manager of the NMP group, told Bloomberg BNA.

HSIA members make solvents that are used by manufacturers large and small to strip paint, degrease machine parts, and clean factory surfaces.

The group also explained how the agency’s risk evaluation differs from a rule the agency proposed to limit NMP’s use in paint strippers, and how these actions differ from some possible EU solvent regulations, Roberts said.

In addition to HSIA, the Consumer Specialty Products Association—which represents the makers of chemical-intensive home care and other consumer products—also provided solvent data to the agency.

Member companies Ecolab, the Sherwin Williams Co., and W.M. Barr & Co. met with the EPA to discuss 1-bromopropane, methylene chloride, NMP, perchloroethylene and trichloroethylene, Steven Bennett, vice president of scientific affairs at the association, told Bloomberg BNA. They offered data on what markets and for what types of customers—consumer, institutional or industrial—the solvents are used by, he said.Honeywell, a diversified technology and manufacturing company, was among the downstream companies that met with EPA staff to discuss its use of perchloroethylene during the hydrofluorocarbon manufacturing process, a company spokeswoman told Bloomberg BNA.

“The Honeywell staff explained that all Honeywell hydrofluorocarbon manufacturing processes take place in a closed system with full pollution control devices. This approach minimizes any emissions of perchloroethylene, with low potential for human exposure,” she said. The EPA previously has concluded similar chemicals manufactured in sufficiently closed systems do not pose unreasonable risk, she said.

Dow Chemical Co. provided use information to the EPA before it issued its preliminary risk evaluation plans in June, Johnathan DiMuro, regulatory services leader, told Bloomberg BNA. The company does not plan to provide more information, he said.

Firemen, Labs and Legacy Carve-Outs

The International Association of Fire Fighters, state officials, the AFL-CIO, environmental groups, and the American Public Health Laboratories association also have provided the EPA chemical toxicity, use and exposure information.

Firefighters, for example, have a higher risk of getting various cancers than does the general population, Larry Petrick, director of health and safety for the International Association of Fire Fighters, told Bloomberg BNA. Firefighters are exposed to building materials such as old ceiling tiles, insulation, asbestos, and furniture sprayed with flame retardants, Petrick said.

Firefighters hope to persuade the EPA to reconsider its June decision to exclude legacy uses from its 10 risk reviews, he said. Petrick referred to decisions the EPA announced in 10 documents it released June 22 describing its preliminary plans to assess hazards, uses of, and exposures to each chemical.

“In the case of asbestos, legacy uses and associated legacy disposals will be excluded from the scope of the risk evaluation. These include asbestos-containing materials that remain in older buildings or are part of older products but for which manufacture, processing, and distribution in commerce are not currently intended, known, or reasonably foreseen,” the agency wrote in a preliminary evaluation plan for that mineral.

The agency made a similar conclusion for carbon tetrachloride, which the U.S. Consumer Product Safety Commission banned in 1970, but which the EPA said may still be used in some paints, coatings, rubber, cement, and asphalt formulations. “Legacy uses and associated legacy disposals will be excluded from the scope of the risk evaluation,” EPA said in its preliminary risk evaluation plan.

Firefighters want the EPA to consider their current legacy-use-based occupational exposures to hazardous chemicals, Petrick said.

The American Public Health Laboratories—which represents a network of state health and environmental labs—wants to share its measurements of the 10 chemicals in air, water, people’s bodies, and other places the chemicals reside, Julianne Nassif, director of environmental health, told Bloomberg BNA.

Shying Away

Asked why more companies didn’t chime in when asked about the information they may plan to give the EPA, several reasons, including lack of familiarity and a desire to stay off the radar, were given.

Especially for manufactured goods producers, it is a new idea to give the EPA information about the chemicals they use, Mark Duvall, a principal in the Washington office of Beveridge & Diamond, P.C. told Bloomberg BNA.

“Companies and trade associations may be looking for experience and guidance to gauge what information EPA actually needs and in what level of detail,” he said. “In addition, EPA’s information requests, where made, tend to be fairly general, which may lead to fairly general responses.”

Companies also may be reluctant to give data that may restrict their products by providing information that EPA might use to decide a chemical should be scrutinized, Duvall said.

Chemical manufacturers can ask their customers to send EPA information, but they’re usually not in a position to insist on it, the NMP group’s Roberts said. Companies that buy chemicals to make consumer and industrial goods may not see a reason to provide the EPA information at this early stage, she said. They may not feel compelled to until the agency proposes to restrict their particular use of chemical, Roberts added.

Beyond the First 10 Chemicals

The American Chemistry Council’s Center for Chemical Safety Act Implementation is working with chemical and product manufacturers to discuss ways companies may contribute to future risk evaluations the EPA will undertake, David Fischer, who helps manage that center told Bloomberg BNA.

Even if EPA isn’t evaluating a chemical a company currently makes or uses, the agency may do so down the road. Chemicals already listed on an EPA “ work plan” list of about 90 chemicals are potential candidates for future risk evaluations as are chemicals of concern identified in other parts of the world, such as the European Union’s Substances of Very High Concern list.

If a company is aware of data gaps for such chemicals, “it may be good to start talking to EPA now,” Fischer said. “There’s an opportunity now, to start filling data gaps.” he said.

Companies also can nominate a chemical for the agency to evaluate or choose to submit their own risk evaluation for it, Fischer said. The company’s risk evaluation would have to meet guidance the EPA published June 22.

Deadlines, State Preemption

The EPA plans to release draft risk evaluations for public comment and peer review as early as 2018. It aims to publish final risk evaluations by the end of 2019, although the amended TSCA law gives the agency until mid-2020 to complete them.

Those risk evaluations could find that some of the 10 chemicals pose no risks. That finding largely would preempt states from regulating the same chemical or chemical use under the amended TSCA law.

The EPA’s risk evaluations also could affect markets even before the reviews are finished. If the science appears to show a chemical or certain uses of it may raise health or ecological concerns, chemical makers could voluntarily drop those uses. Sales of those chemicals also could drop ahead of the completion of a risk review if the market responds to feedback from consumers or watchdog groups.

The EPA’s evaluation would trigger a regulation if the agency concluded one or more uses of any of the 10 chemicals poses an unreasonable risk to people or the environment. Such regulations would be intended to benefit human or environmental health by reducing disease, lost productivity, and other costs.

To contact the reporter on this story: Pat Rizzuto in Washington at prizzuto@bna.com

To contact the editor responsible for this story: Rachael Daigle at rdaigle@bna.com

For More Information

EPA information on its chemical risk evaluation and management program is available at http://src.bna.com/sfb.

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