Chemical manufacturers’ intellectual property wouldn’t be released to the public even if the EPA completes a proposal to increase access to the science it uses to decide whether chemicals could hurt people or the environment, industry representatives said.
The proposal (RIN 2080-AA14) would require scientific data be sufficiently available to the public so that interested parties could understand how the Environmental Protection Agency reached its conclusions. That would include information the agency uses in models that predict how chemicals affect people and the environment.
Chemical toxicity and exposure data that companies spend time and money generating and submit to the agency couldn’t be disclosed, however, because it has commercial value, Christina Franz, an attorney and senior director at the American Chemistry Council, told Bloomberg Environment.
Trade secrets, Franz said, along with commercial and financial information already are protected under a separate law that would remain in effect: the Freedom of Information Act.
The EPA has invited supporters and critics of the proposed rule to a July 17 public hearing about it, and the agency extended the comment period through Aug. 17.
Public vs. Private Interests
Critics of the proposed rule say company-generated information would be protected and used, while academic and public health data might have to be fully public.
The rule could put regulated industries’ interests above public health considerations, Rep. Eddie Bernice Johnson (D-Texas), top Democrat of the House Committee on Science, Space, and Technology, wrote in comments she submitted May 24.
“Prioritizing the confidentiality of private entities could lead to the publication or release of data that is supported by industry and could bias the usable body of evidence for the EPA towards a particular industry position,” she said.
“The promulgation of this proposed rule would set a dangerous and potentially life-threatening precedent regarding the use of health-based data, modeling, and research in regulatory decision-making,” John Linc Stine, commissioner of Minnesota’s Pollution Control Agency, and Jan Malcolm, commissioner of the state’s health department, wrote in a May 15 letter to EPA Administrator Scott Pruitt.
But Mike Walls, vice president of regulatory and technical affairs at the chemistry council, is among the supporters of the rule who said it protects both companies and people.
“We think this policy protects key business and personal privacy interests, and help ensure that there’s a sound scientific basis for the decisions the agency makes,” Walls said.
The chemistry council represents companies including the 3M Co., Albemarle Corp., Momentive Performance Materials Inc., and Procter & Gamble’s Chemicals.
Impact on Chemicals
The rule would apply to data and models that play pivotal roles in significant regulatory actions, typically ones with a $100 million or more annual economic impact.
Some rules restricting chemicals in commerce could easily meet the proposal’s criteria, Walls said.
But decisions the EPA makes about whether to allow new chemicals into commerce would largely be unaffected, Richard Engler, a senior chemist with Bergeson & Campbell, P.C.'s Washington office, told Bloomberg Environment.
The proposed rule would help achieve two central goals of the Toxic Substances Control Act amendments of 2016, Walls said. Those goals are TSCA’s requirement that the EPA use the best available science and weigh criteria such as the quality of evidence it uses to review chemicals, he said.
It would direct the EPA to base decisions on scientific principles already found in guidance that the agency issued under previous Democratic and Republican administrations, in government-wide guidance issued by the Office of Management and Budget, and in the TSCA amendments, Walls said.
Articulating the guidance in a rule, however, puts teeth into into it, said James G. Votaw, a chemicals and pesticide attorney with Keller and Heckman LLP’s Washington office, during a recent webinar that law firm hosted.
That rule’s transparency requirement would mean people could understand the models the agency uses to predict chemical hazards, said David Fischer, a senior director at the chemistry council.
“In the past we’ve only gotten bits and pieces of these models, and so we don’t have full confidence in them,” he said. Yet, models “are very powerful tools.”
The rule’s objective that scientific information be available is good, Dale Hattis, a risk assessment and biology professor at Clark University, told Bloomberg Environment.
But the rule presumes science often will buttress the position that low doses of chemicals would not be harmful, he said. That presumption is not supported by research on how chemicals move through and interact with the body.
Sometimes there’s no safe dose due to the biological changes a chemical has, particularly molecules that can cause cancer by damaging DNA, he added.
Other times people’s exposure to a chemical from one particular source—perhaps its use in certain consumer products—adds to the larger total exposure to that same chemical, Hattis said.
That total exposure would exceed any alleged safe dose, he said.
There’s no empirical basis to support the rule’s presumption that chemicals have a safe dose or “threshold,” Tracey Woodruff, an environmental health professor at the University of California San Francisco and former senior scientist in the EPA’s policy office, told Bloomberg Environment.
Fischer, from the chemistry council, said the rule doesn’t support any specific theory on whether a chemical has a safe dose. It just requires the agency to base its conclusions on scientific data, he said.
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