By Pat Rizzuto
March 21 --A draft House bill that would modernize the Toxic Substances Control Act needs to make its requirements on the Environmental Protection Agency more practicable if it wants the EPA to improve its oversight of chemicals, two former agency officials told Bloomberg BNA.
The cumulative effect of the requirements that different sections of the bill would impose on the agency--to establish criteria to evaluate the quality of information, to make legal determinations concerning the proportionality and net benefits of managing risks and to determine the technical and economic feasibility of alternative chemicals and the likelihood that they would be used, for example--could make the agency's authority to manage chemicals as unwieldy as it has been under TSCA, or more so, the officials said.
Yet, apparently small changes to the language could make the draft bill more workable, they said.
Charles Auer, a private consultant who worked on chemicals assessment and management for 32 years at the EPA and directed the agency's Office of Pollution Prevention and Toxics, and Steve Owens, an attorney with Squire Sanders LLP who served under President Barack Obama as the EPA's assistant administrator of chemical safety and pollution prevention, discussed the proposed Chemicals in Commerce Act.
Rep. John Shimkus (R-Ill.), chairman of the Commerce Committee's Subcommittee on Environment and the Economy, began to circulate in February a discussion draft of legislation that would modernize the Toxic Substances Control Act. The subcommittee held a hearing on the draft March 12 .
Shimkus repeatedly has said he is open to suggestions to improve the draft. The subcommittee is likely to hold a second hearing on the draft in early April before introducing a bill, committee staff told Bloomberg BNA March 20.
Democrats raised many concerns about the draft during the March 12 hearing.
The proposal would allow the agency to reduce exposures to dangerous chemicals only if substitutes were available; it would require numerous analyses before the agency could act; and it would give the agency the authority to require toxicity, exposure and other information on chemicals only in a limited set of circumstances, said Rep. Henry Waxman (D-Calif.), ranking member of the House Energy and Commerce Committee.
In interviews with Bloomberg BNA, Auer and Owens focused on the workability of the discussion draft for the agency.
The discussion draft has many core elements that would improve the agency's ability to manage chemicals, both former EPA officials said. Nonetheless, they said revisions could help the agency achieve the goal of better managing chemicals.
Jim Jones, the assistant administrator of chemical safety and pollution prevention, had told the subcommittee in November 2013 that any TSCA-reform bill should include deadlines for certain agency actions .
Auer and Owens also said a bill revising TSCA should include deadlines, but the discussion draft doesn't include deadlines for the agency to prioritize chemicals or evaluate them for safety.
Section 6 of the discussion draft directs the agency “as soon as feasible” to designate all chemicals active in commerce as either low or high priorities for safety determinations. The draft does not enumerate deadlines for the safety determinations.
Deadlines that set out the period of time Congress would give the agency to complete all of its prioritizations and safety determinations--and perhaps interim deadlines for portions of that work--would help, Auer said.
They would enumerate Congress's expectations as to when the EPA is to complete the jobs, he said.
Having congressional deadlines also would help ensure that the Office of Management and Budget (OMB) completes its reviews in a timely manner, Auer said.
Additional deadline-related challenges that the discussion draft would present include its provision that the agency develop “information quality” policies and procedures and the requirement, in Section 22, that all policies, procedures and guidance necessary to implement the act would need to undergo public notice and comment, they said.
The EPA is directed to develop, provide notice of and offer an opportunity to comment on a risk-based process for setting priorities and to have that process in place within one year of the law's enactment, Owens said.
Yet that process, as well as all the policies, procedures and guidances needed for its implementation, would probably have to be reviewed by the OMB, he said.
It would be difficult for the EPA to have the priority-setting process developed, commented on and cleared by OMB within one year, Owens said.
Indeed, having the OMB clear all policies, procedures and guidance will create a challenge for the agency, he said.
Auer said other aspects of Section 22's requirements also could be difficult to implement.
For example, the EPA would be required to establish criteria for ensuring the “high quality” of information it considered in making decisions, he said.
Criteria implies the agency would have some numerically specific way to distinguish high- and low-quality information, Auer said.
The discussion draft would be more workable if the language, for example, directed the EPA to establish “guidance and where appropriate criteria,” Auer said.
Other parts of the discussion draft need to be revised if the intent is to give the agency the authority and flexibility it needs to achieve the goal of effectively managing chemicals, Auer and Owens said.
In general, Section 4 of the discussion draft, which would provide the agency authority to obtain toxicity, exposure and other test data on chemicals, would be easier to apply than its equivalent in TSCA's Section 4, Auer said.
Whereas TSCA requires the agency to make certain legal findings before it can compel the submission of data, the discussion draft would require the agency to issue a statement of need explaining its reasoning, he said.
“It's perfectly reasonable to have EPA explain its thinking,” Auer said.
It is, however, a procedural step that might be challenged in court, Auer and Owens said.
For example, the discussion draft would require the agency to explain the basis for any testing order that would require the use of vertebrate animals. Opponents of animal tests might be able to challenge the agency's position that the test data are needed, Auer said.
There may be a way to have Congress direct the agency to make clear why existing data are inadequate to determine safety in a manner that limits the possibility of legal challenges to test orders, he said.
Section 6, which would provide the EPA authority to regulate chemicals in commerce, would impose many new requirements on the agency, they said.
For example, Section 6 of the discussion draft would require the EPA to make many determinations--or legal findings--before it could restrict a chemical that causes a health or environmental risk, Auer said.
In contrast, Section 6 of TSCA merely requires that the EPA “consider and publish a statement” concerning such aspects, Auer said.
Some of the determinations that the discussion draft would require are phrased using concepts that are entirely new to TSCA and thus unclear, he said.
The determinations include an EPA finding, backed by evidence, that any requirement or restriction the agency would impose is “proportional to the risks of the chemical substance” and result in “net benefits,” Auer said.
Restrictions imposed also would have to be “cost-effective,” under the discussion draft.
The proposed bill would authorize the EPA to impose requirements or restrictions that prohibit specific uses of a chemical only “when technically and economically feasible alternatives that materially reduce risk to human health or the environment” are “available and likely to be used.”
Auer questioned how the agency could make a legal determination that showed it had knowledge that an alternative would likely be used.
Owens said it is beyond the EPA's ability to determine what alternative chemical would work for each company's particular use.
Further, the chemicals of concern could continue to be used because the agency might not be able to demonstrate the availability of technically and economically feasible alternatives, Owens said.
Thus safer chemicals might have a harder time getting markets, he said.
The analytic requirements would increase as the uses of a chemical of concern increase, Auer said.
If a chemical has multiple uses, then the agency would have to make separate determinations for each use. That would include analyzing the alternatives for each of the uses, Auer said.
The need to comply with all the requirements in Sections 4, 6 and 22 would make the agency's authority to manage chemical risks as or even more unwieldy to exercise than TSCA has proven to be, Owens said.
Legislators could direct the EPA to “consider” the various factors the discussion draft wants it to, Auer said.
The word “consider” still would impose burdens on the EPA but not require it to legally conclude it has sufficient information to determine characteristics such as a rule imposing restrictions that would be proportional to the risks of the chemical substance while also providing net cost-effective benefits, he said.
Auer and Owens discussed a strategy for giving the agency more flexibility in determining when test data are needed for one or more chemicals.
As drafted, Owens said it appears the agency would not have the authority to require test data to screen chemicals, precluding any prioritization (low to high) for safety determinations.
The draft would allow “limited data” to be a factor the agency could use in deciding a chemical would be a high priority, Auer said, describing that as an indirect way to obtain test data for chemicals with limited information.
The draft would be more workable if it gave the agency clearer authority to require screening testing when needed for prioritization, Auer and Owens said.
While at the agency, Auer oversaw a multiyear effort through which the EPA tried to obtain information voluntarily about chemicals produced in volumes greater than 1 million pounds annually.
The agency announced its intent to launch that voluntary initiative, the High Production Volume (HPV) Chemical Challenge, in 1998 .
The EPA recently told Bloomberg BNA it currently cannot determine the number of HPV chemicals for which it has obtained sufficient data to screen for potential concerns .
The discussion draft would help the EPA better prioritize chemicals if it allowed the agency to use factors such as high production volume, or exposure potential for lower-volume chemicals, and authorize the agency to get basic screening-level data for those chemicals, Auer said.
Notwithstanding their concerns, Auer and Owens said core elements within the discussion draft would increase the tools the agency could use to obtain toxicity, exposure and other data on chemicals.
Under TSCA, the only authority the agency has to compel the submission of test data is to issue a regulation mandating it.
The proposed Chemicals in Commerce Act, like its Senate counterpart, the Chemical Safety Improvement Act (S. 1009), would authorize the agency to obtain needed test data by issuing administrative orders, negotiating consent agreements or issuing regulations.
Another improvement, they said, would be the requirements in both the House discussion draft and S. 1009 that the agency develop a list of chemicals that are in commerce and a list of those that are not currently in commerce.
“An inventory reset would be very useful,” Owens said. That would enable the agency to focus its resources on chemicals actively used in commerce, he said.
The House's proposed Chemicals in Commerce Act and the Senate's Chemical Safety Improvement Act each have some strengths and weaknesses, Auer and Owens said.
The discussion draft and bill have more in common than they have differences, the two former EPA officials said.
“I'm optimistic that TSCA reform can be achieved,” Owens said. “There is a good chance of some agreement being reached.”
That chance depends, however, on legislators addressing state concerns about preemption, Auer and Owens said.
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