A striking difference between the Senate and House bills – S. 697 and H.R. 2576 – is their length. The Senate bill weighs in at 179 pages, the House bill at 46 pages.
The brevity of the House bill reflects a strategy of trying to address TSCA’s biggest problems and otherwise leaving existing law intact. The Senate bill, by contrast, paints with a much broader brush; almost no provision of the existing law is left untouched.
Its proponents have portrayed the Senate approach as “comprehensive”, suggesting that it achieves broad, across-the-board improvements in TSCA that the more targeted House bill fails to make.
But does a “comprehensive” bill necessarily mean a better chemical safety program?
Or is the opposite the case: is the Senate bill bloated with provisions that won’t help EPA protect public health and the environment but instead fix imaginary problems or, worse, place large new administrative burdens on EPA which will only make its job tougher?
An answer to this question is suggested by the numerous rules, guidance, procedures, and strategies that the Senate bill requires EPA to issue in the early years of implementation. These requirements – totaling 15 in all – include:
- Policies, procedures and guidance on the use of science in making decisions (sec. 3A(c))
- Policies and procedures for the testing of chemical substances and mixtures (sec. 3A(g))
- Rulemaking to establish policies and procedures for safety assessments and safety determinations (sec. 3A(h)(2))
- Guidance to assist interested parties in developing their own safety assessments (sec. 3A(h)(2)(D))
- A strategic plan to reduce testing on vertebrate animals (sec. 4(c)(2))
- Guidance on tiered testing (sec. 4(d)(4))
- Rulemaking to establish a risk-based prioritization screening process (sec. 4A(a)(1))
- Rulemaking to establish procedures and criteria by which manufacturers can propose chemicals for safety assessments and determinations (sec. 4A(c)(1)(A))
- Rulemaking requiring reporting of information necessary to carry out sections 4 and 6 (sec.8(a)(4))
- Guidance for reporting under section 8(a) (sec. 8(a)(5))
- Rulemaking to require reporting for the Active Substance Inventory (sec. 8(b)(4)(A))
- A plan to review CBI claims for active substances (sec. 8(b)(4)(C))
- Rulemaking to carry out export notification requirements (sec. 12(b)(2))
- Guidance on development of generic names for CBI substances (sec. 14(d)(3))
- Rules for payment of fees by industry (sec. 26(b)(1))
Most of these actions must be completed within 2 years and many in 1 year. Thus, EPA will be overburdened with administrative requirements at the very time it is struggling to increase the pace of safety assessments and risk management on chemicals that fail to meet the safety standard.
There may be a few areas where implementing guidance will be necessary under the new law. For example, the Senate bill requires a retrospective review of CBI claims for the molecular identity of chemicals listed on the existing TSCA inventory. This positive effort to increase transparency (lacking in the House bill) may well require EPA guidance or even rulemaking to be successful.
However, the sheer volume of rules, guidance and procedures required by the Senate bill far exceeds the minimum necessary for effective TSCA reform and threatens to compromise timely implementation of the new law. Rulemaking and guidance development are resource-intensive, involving public comment, OMB review and, inevitably, litigation and the accompanying uncertainty when one or more stakeholders are unhappy with the outcome. With so many administrative tasks required of EPA in a limited period, delays will be unavoidable, potentially leading to more litigation and placing demands on EPA resources and management time well after initial deadlines have come and gone.
The House bill makes it much easier for EPA to focus on protecting public health
None of the implementing actions called for by the Senate bill is required by H.R. 2576. This will greatly simplify the task of putting a new TSCA program in place, and make it much easier for EPA to focus on the central task of completing risk evaluations and rulemakings to increase protection of public health.
The Senate bill overburdens EPA with many unnecessary requirements
If the administrative requirements in the Senate bill resulted in a more effective and protective chemical management program, the resource tradeoffs might be worth considering. But in reality most of these requirements simply add process and paperwork and create litigation opportunities without enhancing the quality of EPA decision-making.
A few examples demonstrate this point.
- The Senate bill’s requirement that EPA develop detailed policies and guidance on the use of science for decision-making has no parallel in current TSCA or any other environmental law. The apparent purpose of this requirement is to assure the quality of the science that EPA uses to make judgments about assessment priorities, testing and chemical risks. But the Agency already has extensive guidelines for conducting risk assessments for different end-points, policy statements addressing such issues as cumulative and aggregate risk, standard protocols for testing, detailed peer review policies and handbooks, and an independent Science Advisory Board which reviews important scientific work products. The agency is continually receiving input on its science policy framework and reexamining its thinking on critical science issues. Adding another set of policies and procedures on top of this existing framework is overkill and will simply provide yet another forum for stakeholders seeking to advance their science policy agendas.
The Senate bill requires EPA to provide opportunities for comment on risk evaluations and rules for individual chemicals and, if stakeholders raise scientific concerns, the agency will be obligated to respond. The ability to provide feedback on the science supporting individual evaluations and rules, coupled with peer review of EPA’s assessments and the agency’s overall science policy framework, will be more than sufficient to ensure that EPA uses the best available science and that diverse scientific perspectives are considered.
The House bill takes a different tack from the Senate, providing limited, general direction to EPA on the use of science in section 26(h) but not requiring new guidance or policies. There are some problems with the House language, but it does a better job of respecting the extensive science framework now in place and protecting EPA’s scarce resources.
- Section 4A of S. 697 creates an elaborate process to set priorities for safety assessments, requiring rulemaking to establish a prioritization process, prescribing criteria for identifying high- and low-priority chemicals and establishing procedures for maintaining and updating the priority list. These provisions grossly overcomplicate a simple task. Priority-setting is merely a means of selecting the chemicals that will receive in-depth review by the Agency; in itself, it implies no definitive judgment about chemical risks or the need for regulation, subjects that will be addressed later in the safety assessment and risk management process.
- Another unnecessary exercise mandated by the Senate bill is the separation of the TSCA Inventory into “active” and “inactive” chemicals (i.e. those not manufactured or imported in the last 10 years). To accomplish this, the bill provides detailed criteria for defining “active” chemical substances, calls for rulemaking requiring reporting by manufacturers and processors of these substances, directs EPA to create and maintain an active substance list, and establishes a mechanism for updating the list. As old timers will recall, creation of the TSCA Inventory in the late 1970s was an arduous multi-year process that involved complicated questions of chemical nomenclature, difficult issues about who was obligated to report and submission of voluminous amounts of information that stretched to the limit EPA’s data-systems. While technology has advanced greatly since then and EPA can build on the established Inventory reporting rules, an Inventory “reset” will still be a challenging task, requiring considerable staff and contractor time to oversee reporting and then manage the huge amount of data submitted to EPA.
The current law contains no mechanism for prioritizing chemicals under section 6 but leaves this task to EPA’s discretion. Without Congressional direction, EPA has developed a prioritization framework – the Work Plan process – that it has used to screen hundreds of chemicals and select dozens for risk assessment. During the many hearings on TSCA reform, there’s been no suggestion that this process is flawed or EPA’s initial risk assessment priorities are misplaced. Yet the Senate bill would replace the Work Plan process with a cumbersome priority-setting mechanism that will create unnecessary work, duplicate previous Work Plan evaluations and slow down the critical task of beginning to assess chemicals of concern.
H.R. 2476 takes a more straightforward and direct approach. It does not require a formal prioritization process or a rulemaking to establish screening criteria. And it does not mandate a priority list as such. Instead, in section 6(b)(3)(A), it simply directs EPA to conduct a risk evaluation for a chemical if it determines that the chemical ”may present an unreasonable risk of injury because of potential hazard and a potential route of exposure under the intended conditions of use.” This is an appropriately low threshold that preserves EPA’s discretion. Moreover, in section 6(b)(3)(B), the House bill gives EPA the ability to conduct risk evaluations on Work Plan chemicals without any threshold determination at all, respecting the agency’s previous efforts to set priorities and avoiding wasteful duplication of effort.
Again, the House approach should get the nod for creating a simple and efficient framework for selecting chemicals for risk evaluation.
The apparent rationale for creating an active substance list is to correct the public perception that all 84,000 Inventory-listed substances are in commercial use when, according to industry, the actual number is much smaller. But is this claimed problem one that EPA should solve or is it an industry public relations concern that doesn’t warrant a complex paperwork exercise of no value in reducing risks to health and the environment?
For the foreseeable future, EPA’s plate will be full assessing and managing the risks of a finite group of chemicals of concern identified through the Work Plan process and other sources. If it wants to select priorities from a larger universe, EPA can use data reported under its Chemical Data Reporting (CDR) program, which in 2012 identified 7500 chemicals annually produced or imported in amounts of 25,000 pounds at one or more sites. (Expanded reporting requirements effective in 2016 are likely to pick up even more chemicals). Further expanding this universe by identifying all active substances listed on the Inventory may give industry a useful talking point – “good news: there are only 40,000 unassessed chemicals in commerce, not 80,000!” – but will have no practical benefit to the TSCA program for years to come.
The House rightly decided against including wasteful and unnecessary Inventory “reset” requirements in H.R. 2576.
The House bill is not perfect but has strength in simplicity
The House bill is far from perfect. The unconstrained ability of industry under the bill to set EPA’s risk evaluation agenda is hard to defend and must be fixed. The bill imposes a “cost-effectiveness” requirement on the selection of remedies under section 6 which will increase analytical burdens on EPA and could force it to compromise public protection on the basis of cost. And the bill conditions EPA’s obligation to initiate risk evaluations on ten chemicals per year “on the availability of appropriations,” a caveat that could mean that this requirement is unenforceable.
That said, the simplicity of the House bill is an important strength because it keeps the focus on essential changes to TSCA and, unlike the Senate bill, avoids overburdening EPA with unnecessary requirements. This compact and targeted approach should be the lodestar for reconciling the two bills once the Senate acts.
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