Richard Denison, Ph.D., is a Lead Senior Scientist.
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[UPDATE 4-29-15: On April 28, 2015, the Senate Environment and Public Works (EPW) Committee passed a revised version of the Lautenberg Act out of the committee on a bipartisan 15-5 vote. The new bill made a few revisions to provisions discussed in this post; see updates below.]
[UPDATE 5-17-15: On May 14, 2015, the House Subcommittee on Environment and the Economy passed a revised version of the TSCA Modernization Act of 2015 out of the subcommittee on a bipartisan 21-0 vote. The new draft made several revisions to provisions discussed in this post; see updates dated 5-17-15 below. UPDATE 5-28-15: The legislation was formally introduced as H.R. 2576 on May 26, 2015. ]
This is the third in a series of blog posts looking at less talked-about, but critically important, elements of bipartisan legislative proposals to reform the Toxic Substances Control Act (TSCA). This post deals with how EPA would select which chemicals would undergo safety evaluations.
Under current TSCA, EPA has no mandate to review the safety of existing chemicals. There are no pacing requirements, such as specifying minimum numbers of chemicals to be examined. The law provides no criteria for EPA to use in identifying chemicals that may pose risks. There are no requirements for EPA to establish goals for reviews or schedules for any reviews it does undertake.
Safety reviews are rarely undertaken, and often consume many years (or even decades) – in large part because there are no mandates or deadlines. As a result of these aspects of the current law, only about 2% of the chemicals that were on the market at the time TSCA was enacted have undergone any sort of safety review.
In 2012, EPA on its own initiative undertook a prioritization process that has led to identification of about 90 so-called “work plan” chemicals, for which EPA is conducting or intends to conduct risk assessments; five have been completed to date.
How would TSCA reform legislation identify chemicals to be subjected to safety reviews?
The Lautenberg Act establishes a risk-based prioritization process through which EPA would identify chemicals to be subject to safety assessments and safety determinations. EPA is mandated to prioritize all chemicals in active commerce. Specific findings and criteria to be used to identify low- and high-priority chemicals are described in the bill, with details to be developed through notice-and-comment rulemaking.
EPA is to conduct safety assessments and safety determinations for all high-priority chemicals, and to set schedules for doing so. The bill specifies concrete judicially enforceable deadlines for each major step: prioritization, safety assessments and determinations, and promulgation of regulations for chemicals found not to meet the bill’s safety standard.
Under the bill, EPA can designate any of its current “work plan chemicals” as high-priority chemicals; indeed, the bill specifies that at least half of all high-priority chemicals EPA identifies are to be drawn from the work plan list until all of them have been so designated. EPA can continue or initiate assessments on any of these chemicals while the bill’s new prioritization and assessment procedures are put in place.
With respect to pace, EPA must include at least 10 chemicals on the initial high-priority list, as well as at least 10 on the low-priority list. By three years after enactment, at least 20 high-priority and 20-low-priority chemicals must have been listed. By five years after enactment, at least 25 high-priority and 25-low-priority chemicals must have been listed.
More generally, EPA is to prioritize chemicals at a pace commensurate with available resources, publish an annual goal for the number of chemicals to be prioritized, and subject all chemicals to prioritization in a “timely manner.” An annual plan and schedule for the completion of safety assessments and determinations must be made public. As final action is taken on a high-priority chemical, at least one new substance must replace it on the high-priority list.
In addition to chemicals that EPA designates as high-priority, the bill provides for companies to request that EPA assess a chemical it has not so designated; at its discretion EPA can grant a limited number of such requests (not to exceed 15% of the total number of chemicals EPA is assessing), but cannot give them preference over high-priority chemicals. Companies are to pay fees to cover the full costs of these assessments. Unlike high-priority chemicals, initiation of assessments on these company-requested chemicals does not trigger preemption of new state requirements.
[UPDATE 4-29-15: Changes made in the bill passed by Senate EPW include:
- EPA is to give preference to chemicals on its work plan list that rank high on persistence and bioaccumulation in designating high-priority chemicals.
- Persistence and bioaccumulation are added as explicit factors EPA is to consider in prioritizing chemicals.
- EPA is to designate chemicals as high-priority for which there is the potential for “significant” hazard and “significant” exposure; the original bill had used “high” hazard and “widespread” exposure.
- The provision described above for EPA at its discretion to accept company-nominated additional priorities now calls for those chemicals to constitute no less than 25% and no more than 30% of the cumulative number of chemicals subject to safety assessments and determinations.
- A new provision has been added for industry to nominate chemicals already on EPA’s work plan for assessments; EPA has discretion to designate such requested chemicals high-priority and if it does, industry is to pay fees to cover 50% of EPA’s assessment costs. The 30% cap noted in the preceding bullet does not apply to these chemicals, and their designation as high-priority is preemptive of new state actions during the safety assessment and determination phase.]
The House discussion draft [UPDATE 5-28-15: H.R. 2576, introduced on May 26, 2015] does not include a prioritization process, nor does it contain any mandate for EPA to review existing chemicals, which appears to perpetuate the situation created under the original law whereby thousands of chemicals needing safety assessments can stay in commerce without any such review.
As with current TSCA, EPA does have authority to review existing chemicals; and while the draft calls on EPA to conduct a “risk evaluation” for any chemical it determines has the potential to present an unreasonable risk, there is no process or means by which such chemicals are to be identified. The bill does not address the pace, number of chemicals, or timelines for identifying chemicals to undergo risk evaluations, nor does it set goals to guide or direct EPA in undertaking risk evaluations of existing chemicals.
[UPDATE 5-17-15: Changes made in the draft passed by the House Environment and the Economy Subcommittee include:
- The finding EPA must make in order to subject a chemical to a risk evaluation was reworded to be “may present an unreasonable risk of injury to health or the environment because of potential hazard and a potential route of exposure under the intended conditions of use.”
- Chemicals on EPA’s Work Plan may be subjected to a risk evaluation with making the “may present” finding just noted.
- “Subject to the availability of appropriations,” EPA is to initiate 10 or more risk evaluations each fiscal year.
- EPA is to identify chemicals that are persistent, bioaccumulative and toxic (PBT) – excluding all metals and metal compounds – to which exposure is likely. These are to be listed within 2 years and subject to risk management “to reduce likely exposure to the extent practicable” within 2 more years.
- However, if EPA finds such a chemical “may present an unreasonable risk” and initiates a risk evaluation, or a company requests EPA conduct a risk evaluation of such a chemical, the requirement to subject the chemical directly to risk management does not apply.
UPDATE 5-28-15: The legislation formally introduced as H.R. 2576 on May 26, 2015 did not make additional relevant changes.]
While there is an absence under the draft of any chemical identification or forcing mechanism for EPA-initiated risk evaluations, EPA would be required to conduct a risk evaluation of any chemical that any manufacturer requests it conduct. Unlike the provision for industry-requested assessments of the Lautenberg Act described above, this process under the House bill is unbounded. No limit is set on the number of such requests, all of which EPA would have to grant.
The full costs of such risk evaluations would be borne by the manufacturer, although those revenues would not go directly to EPA but rather into the general treasury [UPDATE 5-17-15: A change made in the draft passed by the House Environment and the Economy Subcommittee directs these fees to a dedicated fund; however, the draft still provides for no fees for EPA-initiated risk evaluations, including for Work Plan chemicals. UPDATE 5-28-15: The legislation formally introduced as H.R. 2576 on May 26, 2015 makes no further changes to the fee provisions]. As with the Lautenberg Act, EPA’s initiation of an industry-requested risk evaluation would not preempt states from taking new actions.
With respect to deadlines, the House draft requires that any risk evaluation EPA conducts at the request of a manufacturer must be completed within six months, whereas any risk evaluation of a chemical EPA initiates based on finding it may present an unreasonable risk is to be completed within three years (the latter is same deadline as in the Lautenberg Act for both EPA-initiated and company-requested safety assessments). [UPDATE 5-17-15: A change made in the draft passed by the House Environment and the Economy Subcommittee removes the six-month deadline for industry-requested risk evaluations and applies the three-year deadline to all risk evaluations. UPDATE 5-28-15: The legislation formally introduced as H.R. 2576 on May 26, 2015 makes no further changes.]
Under the House bill, if the risk evaluation were to find a chemical presented an unreasonable risk, EPA would have six more months to promulgate a final risk management rule. To my knowledge EPA under TSCA has never completed a full risk assessment or even the simplest of rulemakings (which by law require taking public comment) in such a short period of time.
These mandates likely mean that EPA would spend virtually all of its effort evaluating those chemicals industry requested it evaluate (which could be sought for non-risk-related reasons, ranging from seeking a competitive advantage to seeking permanent relief from state regulation), rather than those EPA would identify as posing the greatest potential risk.
Next up: Confidential business information.