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By Pat Rizzuto
The Environmental Protection Agency released June 22 final rules establishing its first-ever, comprehensive regulatory strategy to evaluate—and regulate, if needed—chemicals in commerce.
The agency also released guidance to help companies, trade associations, or other non-agency parties submit draft chemical risk evaluations for the EPA’s consideration.
Additionally, the agency released strategies, or “scoping documents,” to identify what uses of 10 chemicals it will evaluate, and information about how it will conduct those evaluations. The EPA invited all interested parties to submit information about those chemicals to help it evaluate their risks.
The new rules and other documents will affect not only chemical manufacturers but also airplane, auto, electronic parts, paint, and other manufacturers and their suppliers and customers. A variety of companies and trade associations commented on and met with the EPA during the development of the rules including the American Fuel & Petrochemical Manufacturers, Auto Alliance, BASF Corp., Consumer Specialty Products Association, Dow Chemical Co., Procter & Gamble Co., and the Sustainable Furnishings Council, among others.
The release of these rules, guidance, and scoping documents marked the one-year anniversary of the Lautenberg Chemical Safety Act, which overhauled the nation’s primary chemicals law. The agency, for the first time, is required by the amended Toxic Substances Control Act to examine the risks of chemicals in commerce by specified deadlines, do so using best available science, and consider the risks chemicals pose to vulnerable and particularly exposed populations.
Congress revised the original 1976 law to give the EPA greater authority to address public and scientific concerns about the ways commercial chemicals—depending on exposure and other considerations—may cause cancer, harm brain development, and contribute to other health and ecological problems. This prompted organizations including the AFL-CIO; California agencies; Environmental Defense Fund; Learning Disabilities Association of America; North America’s Building Trades Union; Safer Chemicals, Healthy Families; and many academic scientists to comment or meet with the agency.
The release of the rules, guidance, and scoping documents by the deadlines set by the Lautenberg Act demonstrate “this administration’s commitment to providing regulatory certainty to American businesses, while protecting human health and the environment,” EPA Administrator Scott Pruitt said in a statement.
“The new process for evaluating existing chemicals outlined in these rules will increase public confidence in chemical safety without stifling innovation,” he said.
The three final rules set the procedures by which the EPA—working with information and perspectives provided by interested and affected parties—will:
The American Chemistry Council praised the EPA for meeting the deadlines set by the Lautenberg Act.
“Congress demanded these framework rules work in tandem to foster a national chemical management system focused on the high priority chemicals actually in commerce that require risk evaluations,” it said in a statement.
“Over the coming days, we will analyze the rules in detail. It is our expectation that under these rules, EPA will not simply meet the minimal requirements of the law, but instead establish the framework for a modern chemical management system capable of meeting 21st century demands. The processes established by these rules are fundamental to EPA’s ability to quickly and efficiently assess chemicals and uses for their priority, evaluate priority risks and take action to manage risks where required,” the chemistry council said.
House Energy and Commerce Committee Ranking Member Frank Pallone Jr. (D-N.J.), however, voiced concern that a newly hired EPA manager with ties to the chemical industry is unduly influencing these and other agency regulations. Pallone sent a letter to Pruitt June 21 raising questions about Nancy Beck, a former American Chemistry Council policy analyst who now serves as EPA’s deputy assistant administrator in the Office of Chemical Safety and Pollution Prevention.
In her new job, Beck is helping develop rules that will regulate her former employers, he said.
“Her appointment has the potential to undermine the scientific integrity of the Environmental Protection Agency’s (EPA) TSCA implementation and the consumer confidence we sought to build with a reformed TSCA,” wrote Pallone, who led the House Democratic efforts to pass the Lautenberg Act last Congress.
The first regulation (RIN:2070-AK24), called the inventory update or reset rule, requires chemical manufacturers and importers—and allows chemical processors such as paint and cleaning product manufacturers—to notify the agency of compounds they’ve made, imported, or processed over the last 10 years.
The EPA said it responded to comments on its proposed rule by streamlining the reporting requirements for manufacturers and processors to make notification easier.
The final inventory update rule also allows companies to jointly notify the agency that a chemical has been active in commerce. This allows for the possibility, for example, that a cleaning product or paint manufacturer may not know the precise identity of one or more chemicals it purchases. In such a case, the processor and its supplier would jointly notify the EPA about the chemicals. Those chemicals would be listed on the active inventory, but the supplier would keep confidential the specific identity of what it sells.
The second regulation (RIN:2070-AK23), called the prioritization rule, establishes a sifting or screening process through which the agency will decide which chemicals raise enough red flags that the potential health or environmental harm they could cause makes them a high priority to evaluate.
The rule describes how the agency also will use that sifting process to determine which chemicals have sufficient information to conclude they are low priorities for risk evaluation. The EPA said its final rule provides more clarity than did its proposal about what constitutes the best available science it will use to make these decisions and how it will work with regulated industries, unions, and other interested parties.
It also establishes two opportunities for public comment, Beck told Bloomberg.
The final prioritization rule does not require a “pre-prioritization” phase envisioned in the agency’s proposed rule. The envisioned phase would have given the agency an undefined amount of time to collect information about a chemical before the EPA launched the formal prioritization period, which the statute says must be completed within one year.
The pre-prioritization state caused a great deal of confusion, Beck said.
“We’ll engage everyone later, probably in September, to talk about what that process should look like.”
The EPA received many comments supporting and objecting to the pre-prioritization phase. The agency responded by concluding it should flesh out the idea with interested parties.
“The agency will promptly initiate an additional stakeholder process, to include an additional public comment opportunity addressing EPA pre-prioritization activities,” the final rule says.
The final regulation, called the risk evaluation rule (RIN:2070-AK20), describes how the EPA will evaluate the risks posed by high priority chemicals. It describes opportunities interested parties will have to comment on those evaluations.
The EPA’s final rule says the agency has the authority to determine which of many potential uses of a chemical it will focus on during its evaluation.
“The proposed rule had talked about looking at ‘all’ conditions of use. When people saw the word ‘all,’ a lot of the public commenters freaked out, like how are you going to do that, you’re going to tie yourself in knots if you try to do everything, you’re going to end up doing nothing well,” Beck said.
The agency’s final rule also defines scientific terms used, but not defined, in the Lautenberg Act. These terms include: “best available science,” “reasonably available information,” “sentinel exposure,” and “weight of the scientific evidence.”
Jeffery Morris, director of the chemicals oversight office, told Bloomberg the final rule allows the EPA to make determinations on the risks—or lack of them—posed by chemicals at any time during the risk evaluation process. “If we identify early on that a chemical use does not present an unreasonable risk, we can make that determination,” Morris said. “Likewise, if we early on identify a use that does present an unreasonable risk, we can do that before the three years.” The Lautenberg Act gives the EPA three years, with a possible extension of six months, to complete its risk evaluation.
If the EPA concludes a chemical or certain uses of it pose an unreasonable risk, the statute requires the agency to reduce those risks.
“The agency must establish risk management measures, by rule, that ensure the safety standard is met under the conditions of use,” said the Senate report that accompanied its version of the law.
Meeting the law’s safety standard means the agency reaches a conclusion “without taking into consideration cost or other non-risk factors, that no unreasonable risk of injury to health or the environment will result from exposure to a chemical substance under the conditions of use.” The agency would have to consider the costs of divergent options to control the risks, availability of alternative chemicals, and other issues as it decided how to manage the risks.
The risk scoping documents are for the following 10 chemicals:
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