Lindsay McCormick is a Project Manager.   When EPA finalized its framework prioritization rule under TSCA last June, the agency deleted its proposed approach to identifying potential candidate chemicals for prioritization.  EDF had supported EPA’s initial proposed rule, and EPA’s decision to delay this process to allow for additional stakeholder engagement tracks closely with the […]

Richard Denison, Ph.D., is a Lead Senior Scientist. Environmental Defense Fund yesterday submitted questions to EPA that we hope are answered by the agency at the public meeting it is convening on December 6th on changes to its new chemicals reviews. Despite providing some new documents in advance of the public meeting, details about EPA’s new […]

Jack Pratt is Chemicals Campaign Director [Use this link to see all of our posts on Dourson.] With Congress back from recess, it is slated to take up the nomination of Michael Dourson to run the toxics office at EPA. Here are links to our recent blog posts documenting why we are deeply concerned about his nomination: […]

Richard Denison, Ph.D., is a Lead Senior Scientist. Environmental Defense Fund has made no secret of our view that many elements of the final framework rules issued by the Trump EPA in July to implement recent reforms to the Toxic Substances Control Act (TSCA) are contrary to law and fail to reflect the best available science.  […]

Richard Denison, Ph.D., is a Lead Senior Scientist. This week marks the first birthday of the Frank R. Lautenberg Chemicals Safety for the 21st Century Act, which was signed into law by President Obama on June 22, 2016, after passing the Senate and House with overwhelming bipartisan support. The Lautenberg Act significantly overhauled and substantially improved […]

Richard Denison, Ph.D., is a Lead Senior Scientist. The Environmental Protection Agency (EPA) yesterday updated its website to provide a current snapshot of the status of new chemical reviews it has been conducting under last year’s amendments to the Toxic Substances Control Act (TSCA).  The statistics show that, despite being faced immediately with a substantial increase […]

Richard Denison, Ph.D., is a Lead Senior Scientist. I blogged last week about the new-but-not-improved Senate Regulatory Accountability Act (RAA), focusing on how it would reinstate some of the worst flaws of the old Toxic Substances Control Act (TSCA) that were fixed in the bipartisan TSCA reform legislation, the Lautenberg Act, signed into law last June. […]

Lindsay McCormick is a Project Manager. Richard Denison, Ph.D., is a Lead Senior Scientist. On February 24th, President Trump signed Executive Order 13777, calling on all government agencies to recommend regulations for “potential repeal, replacement, or modification.” As of this writing, EPA has received 46,050 comments on its regulatory reform process. Interestingly, the overwhelming majority of these […]

Richard Denison, Ph.D., is a Lead Senior Scientist. Last week, as anticipated, Senator Rob Portman introduced his updated Regulatory Accountability Act (RAA).  Sens. Hatch, Heitcamp and Manchin cosponsored the bill. While it’s new, it can’t be said it’s improved.  Some problems raised with Sen. Portman’s earlier version of the bill were addressed but many were not […]

Richard Denison, Ph.D., is a Lead Senior Scientist. The lead article in this past Sunday’s New York Times is titled “With Trump Appointees, a Raft of Potential Conflicts and ‘No Transparency’.”  It features several prominent examples of recent political appointments of industry representatives and industry lobbyists to key policy positions where they are now charged with […]

Richard Denison, Ph.D., is a Lead Senior Scientist. As more details emerge about the Trump Administration’s proposed budget cuts, it’s becoming clearer that the public’s health could well take one of the worst hits.  Trump has proposed a 31% cut to the budget of the Environmental Protection Agency (EPA), paired with similarly deep reductions in staff.  […]

Richard Denison, Ph.D., is a Lead Senior Scientist. There is a swirl of activity underway around implementation of the Lautenberg Act, last year’s overhaul of the Toxic Substances Control Act (TSCA), and we’ve been blogging quite a bit about those developments. I’ve taken a step back here from implementation, however, and developed a new “primer” that discusses […]

By Jennifer McPartland

Jennifer McPartland, Ph.D., is a Senior Scientist with the Health Program.

Trichloroethylene, or TCE for short, is a very toxic chemical. No doubt about it. Among other health effects, TCE is known to cause cancer and interfere with development.  It is also toxic to the immune system and kidneys. While the vast majority of TCE in the U.S. is used to make other chemicals (i.e., is used as a chemical intermediate), approximately 15% of TCE has other commercial and consumer purposes, including as a metal degreaser and spot cleaning agent.

Over the past several years, the Environmental Protection Agency (EPA) took a hard look at exposures and potential health risks—including to workers, consumers, and bystanders—resulting from certain commercial and consumer uses of TCE. It found clearly excessive risks from these uses, which prompted the agency to take steps to reduce these exposures.

In December 2016, using its authority under section 6 of the Toxic Substances Control Act (TSCA), EPA proposed a rule to ban the use of TCE as an aerosol degreaser and as a spot cleaning agent in commercial dry cleaning facilities—marking the first time in nearly 3 decades it has tried to restrict a chemical under TSCA. A second proposed rule to ban the use of TCE as a vapor degreaser followed a month later in January 2017 and is undergoing public comment.

The public comment period on the first TCE proposed rule closed recently. EDF filed extensive comments urging the agency to finalize the rule as soon as possible.

Highlights of our comments are below:  

• EPA’s risk assessment of TCE’s use as an aerosol degreaser and as a spot cleaning agent in dry cleaning facilities is scientifically rigorous and meets TSCA’s requirements to use the best available science and apply a weight-of-the-scientific-evidence approach. EPA’s TCE assessment and associated methodologies have undergone extensive public comment and peer review.
• This assessment has clearly identified multiple types of risks that are unreasonable, including to specific subpopulations such as workers and pregnant women.
• EPA has shown that a ban of these uses under TSCA is necessary to address the risks, as actions taken and authorities available under other statutes are not sufficient.
• EPA has also shown that options short of a ban on these uses, such as imposing concentration limits or relying on personal protective equipment (PPE), are not sufficient to address the unreasonable risks.

While EPA has more than established that these uses of TCE present unreasonable risks, as it proceeds with future risk evaluations, EDF strongly encourages the agency to move toward a unified approach to assessing cancer and non-cancer risks as recommended by the National Academy of Sciences.

EDF urges EPA to move expeditiously to finalize the rule to meet the applicable deadline of finalizing it by December, a year after its proposal.

The amendments made to TSCA last year clearly authorized EPA to move forward with its assessment of these uses of TCE and to impose restrictions needed to address unreasonable risks it identified.  This express authorization under the law flies in the face of what some have proposed, that EPA abandon its rule, postpone taking any action on these uses, and instead fold them into a separate risk evaluation EPA has just started to look at other uses of TCE.  Taking that approach would delay any action on these high-risk uses for many years.

The fate of EPA’s proposed ban on these uses of TCE will be an important test on whether the agency can finally act effectively to protect the public from harmful exposures using its new authorities under the recently amended TSCA.

By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.

A major reform of the Toxic Substances Control Act (TSCA) made by last year’s Lautenberg Act was to set in motion a process to ensure that EPA (and the public, to the maximum extent practicable) know how many and which chemicals are actually in use today, and to ensure that the identities of any active chemicals that are not publicly disclosed constitute actual trade secrets.

In January, EPA took its first step to implement this reform by issuing its proposed rule for Inventory notification.  The public comment period on this proposed rule closed recently.  EDF submitted extensive comments, which are available here.

The Inventory notification requirements of TSCA as amended by the Lautenberg Act, specified under sections 8(b)(4)(A)(i) and 8(b)(4)(B)(ii), have two interlocked purposes:

1. to ensure EPA has a full and current list of all chemical substances on the TSCA Inventory that are actively being made and processed – paramount to many other aspects of the law, especially the prioritization and risk evaluation provisions of section 6 and, more generally, in providing an up-to-date understanding of the magnitude of chemical production and use within the scope of TSCA relevant to long-term planning and resource allocation; and
2. to ensure that the only active chemicals not identified by name on the Inventory are those whose identities are actual trade secrets, by requiring reassertion, substantiation and EPA review of any prior confidential business information (CBI) claims a company has made and seeks to retain to protect its chemicals’ identities from public disclosure on the updated Inventory.

Many of EDF’s comments are aimed at ensuring that EPA’s proposed rule serves both purposes and is fully in compliance with the law.  In contrast, many comments received from industry interests would pit the first objective against the second and do so in ways that would not comply with what the law requires.  

As detailed in EDF’s submitted comments, the law is quite straightforward in what it requires in the Inventory notification process:

• Each manufacturer must, within 6 months of promulgation of this final rule, notify EPA of each chemical on the current TSCA Inventory that it has manufactured during the 10 years preceding the new law’s date of enactment (which are then deemed to be “active” chemicals). [Section 8(b)(4)(A)(i)]
• If the manufacturer wishes to continue to protect from disclosure the identity of its active chemical on the updated Inventory, it must include a request to do so in its notification to EPA. [Section 8(b)(4)(B)(ii)]  This option is limited, of course, only to chemicals that are currently on the confidential portion of the Inventory.
• EPA can require chemical processors to do the same. [Section 8(b)(4)(A)(i)]

The first requirement of the law – that each manufacturer must notify EPA of each active chemical it manufactures – is not only intended to serve the first objective of Inventory notification;  it is essential to achieving the second objective of ensuring that chemical identities that are not or are no longer trade secrets are not hidden from the public.

Some industry interests are arguing for two approaches, neither of which is allowed under the law and both of which would preclude the Inventory notification process from achieving its second key objective.  Each of these proposals is discussed below.

“One and done” is wrong and dumb

Some in the industry are pushing for an approach they have dubbed “one and done.”

Two big problems.  First, the proposal would have EPA rewrite the law’s requirement that each manufacturer notify EPA of its active chemical, to instead allow that once one company has notified EPA of a chemical, no other company need do so.  TSCA Section 8(b)(4)(A)(i) states (emphases added):

(i) IN GENERAL.—Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator, by rule, shall require manufacturers, and may require processors, subject to the limitations under subsection (a)(5)(A), to notify the Administrator, by not later than 180 days after the date on which the final rule is published in the Federal Register, of each chemical substance on the list published under paragraph (1) that the manufacturer or processor, as applicable, has manufactured or processed for a nonexempt commercial purpose during the 10-year period ending on the day before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.

Clearly this provision requires each manufacturer of a substance on the Inventory to notify EPA if it has been manufacturing it recently.  Nothing in this language allows for a subset of such manufacturers to file notices.

Second, the industry’s proposal won’t work in practice and likely won’t be desirable even to them.  Recall that part of the notice a manufacturer must file is a reassertion of any existing claim to protect from disclosure the identity of a chemical the company wishes to maintain; see section 8(b)(4)(B)(ii).  Such CBI claims and the basis for them are, of course, specific to the company asserting a claim.  If the Inventory notification process for a chemical could stop after the first notice is received, that could well mean that only that first notifier’s CBI claim would be asserted – and even then only if that notifier had an existing claim and wished to reassert it.  Under this scenario, requests to maintain existing CBI claims originating with other manufacturers of that same chemical might well not be received by EPA.

In this context, the law is clear that the identity of any active chemical for which no requests are received through the Inventory notification process to renew an existing CBI claim must be disclosed to the public [section 8(b)(4)(B)(iv); emphasis added]:

(B) CONFIDENTIAL CHEMICAL SUBSTANCES.—In promulgating a rule under subparagraph (A), the Administrator shall—

(iv) move any active chemical substance for which no request was received to maintain an existing claim for protection against disclosure of the specific chemical identity of the chemical substance as confidential from the confidential portion of the list published under paragraph (1) to the nonconfidential portion of that list.

I suspect that is not an outcome those in industry urging EPA to stop the Inventory notification process for a chemical after receipt of the first notice would be pleased with.

To try to address this problem that “one and done” would create, one industry commenter seeks to demand that EPA go through an additional, convoluted process that is not in the law at all, in order to ensure that “all potentially affected manufacturers and processors have had a full opportunity to reassert CBI claims” and that “if an ‘early’ notifier decides to waive an existing CBI claim, that action cannot itself prejudice subsequent notifiers or deprive them of an opportunity to reassert a claim.”

This tries to shift to EPA a burden that the law clearly places on companies.  And it begs the question why EPA should have to provide “all potentially affected manufacturers and processors” yet another “full opportunity to reassert CBI claims” when they just chose not to take up the opportunity afforded them under the law and EPA’s proposed rule to do so via the Inventory notification process.

In sum, the new law is clear that all manufacturers must notify EPA of their active manufacture of a chemical, and that, unless one or more of those companies reassert any existing CBI claims at that time (and those claims are later reviewed and found to be warranted), the identity of that chemical is to be made public.

CBI claims are company-specific and can’t be “borrowed” by other companies

Some 17,000 chemical identities on the Inventory are confidential at present, denying the public the ability to know the full range of chemicals being made and used in the U.S.  In enacting the Inventory notification provisions, Congress wanted EPA not only to update the Inventory to identify chemicals in active commerce, but also to require EPA to retrospectively review this large backlog of CBI claims to ensure that if the public is to continue to be denied access to some chemical identities, they are limited only to those that actually warrant protection from disclosure.

Congress did not intend for the Inventory notification process to be a means by which companies could assert new CBI claims for chemical identity.  The intent was to provide a means for EPA to review already existing chemical identity claims to determine if they are still warranted.

Consistent with this Congressional intent, the language of the law expressly provides only for requests under the Inventory notification process to “maintain an existing claim,” not to assert a new one; see section 8(b)(4)(B)(ii).  Because CBI claims are company-specific, it should not be possible for a company to seek to “maintain” a claim it did not make.

Unfortunately, EPA has proposed to allow a company to request to maintain a CBI claim for chemical identity through the Inventory notification that it had not asserted.  Industry interests have supported this approach in their comments.  EDF strongly disagrees:  we believe this approach is not allowed by law, and it would clearly frustrate achieving the second objective of the Inventory notification process.  In our comments, we argue that EPA’s final Inventory notification rule needs to specifically state that no company that had not previously asserted a CBI claim for the identity of a chemical substance can request that such a claim be maintained through the Inventory notification process.

None of this is to say that a company cannot at any point assert a new claim for CBI protection of the identity of a chemical on the confidential portion of the Inventory.  The law clearly provides for that to be done – but only through the procedures and requirements of section 14.  EPA should make clear that any new claim to protect the identity of a chemical must be asserted and addressed as laid out in section 14.

This is not a trivial distinction:  Among other differences, the section 14 process would require EPA to review such a claim within 90 days, rather than the potentially much longer timeframe provided under section 8(b)(4)(B), (C) and (D).  The much longer period (5-7 years) provided under the new law for EPA review of pre-existing CBI claims for chemical identity was an acknowledgment of the large number of such claims potentially requiring review; compounding that problem by allowing new claims to be asserted and then reviewed under the review plan would run entirely counter to the intent of this provision of the law.

Section 14 of the Lautenberg Act provides ample means to meet the needs EPA identifies in its rationale for its proposed approach:

A number of manufacturers and processors may legitimately benefit from the confidential status of a specific chemical identity, and the initial claimant may no longer exist.  EPA does not believe that Congress intended for specific confidential chemical identities to be disclosed without providing the opportunity for manufacturers and processors to make a request that the identities should remain confidential simply because the original claimants no longer manufacture the chemical substances.

Section 14 provides a clear and direct “opportunity for manufacturers and processors to make a request that the identities should remain confidential.”  Any company seeking to “legitimately benefit from the confidential status of a specific chemical identity” can do so simply by asserting a CBI claim for that chemical identity through the means provided under the Lautenberg Act, i.e., in conformance with the procedures and requirements delineated in section 14.  To do so, there is no need for a company to seek to identify the original or any other claimant.

 

In contrast to both of these proposals embraced by industry, the most straightforward approach is also the one that comports with the law.

By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.  Lindsay McCormick is a Project Manager.  Jennifer McPartland, Ph.D., is a Senior Scientist.

Environmental Defense Fund (EDF) filed extensive comments yesterday on the Environmental Protection Agency’s (EPA) proposals for the two most central “framework” rules mandated by last year’s Lautenberg Act amendments to the Toxic Substances Control Act (TSCA).

Our comments address these proposed rules:

• TSCA Procedures for Prioritization of Chemicals for Risk Evaluation, the rule that sets up the process EPA will use to identify high-priority chemicals for risk evaluation and low-priority chemicals that do not require risk evaluation.
• TSCA Procedures for Chemical Risk Evaluation, the rule that sets up the process EPA will use to conduct risk evaluations on high-priority chemicals and make risk determinations as to whether or not the chemicals present unreasonable risk to human health or the environment

Both sets of comments address many different provisions of the proposed rules.  EDF indicated our strong support for many aspects of the proposals, but urged changes to a number of provisions that we cannot support as proposed.  In addition, we identified provisions we believe need to be added to EPA’s rules to be consistent with or meet the requirements of the Lautenberg Act.

EDF emphasized how vital it is for EPA to meet its June 22, 2017, statutory deadline for promulgating these rules.  Because they establish processes that will require several years to begin to yield decisions on specific chemicals, delays in promulgating them in final form so that the processes can commence in the timeframe Congress intended will only serve to undermine public confidence in the new law, counter business interests to restore confidence in the chemicals marketplace, and hamper EPA’s ability to carry out its new mandates.  This is especially the case, given EPA’s appropriate recognition in both proposed rules that it will need to initiate measures as soon as possible to ensure that sufficient information will be available to inform prioritization and risk evaluation decisions.

As discussed in more detail in the comments, EDF strongly supports EPA’s decision not to codify specific scientific policies, procedures and guidance in these rules.  To do so would not be consistent with the law and would more generally represent bad policy.  EDF also agreed with EPA’s proposal not to define in its rules complex, science policy-laden terms such as “weight of the scientific evidence,” “best available science,” and “unreasonable risk.”  These concepts are best elaborated on in guidance and policy statements and best understood in the context of specific decisions on chemical substances.

Some other highlights from each set of EDF’s comments follow.  

Prioritization:

EPA appropriately proposes a rule that:

• is procedural in nature and avoids specifying science policy issues that are better addressed in guidance and policy statements;
• provides the right level of detail on the prioritization process and does not propose an exact scoring or ranking process;
• includes a “pre-prioritization” stage to gather needed data and meet the statutory requirements of the Lautenberg Act, which EDF urges the agency to keep simple and informal;
• makes clear that chemical substances, not specific uses or subsets of uses, are to be prioritized; and
• sets a higher bar for low-priority than for high-priority designations

EDF raised concerns about several other aspects:

• EPA’s proposal to “cut off” comments on proposed low-priority designations after the public comment period, which requires several conditions to be acceptable;
• EPA’s proposal to consider substitutes in the pre-prioritization process;
• insufficient incorporation of measures to ensure public access to information EPA uses to make prioritization decisions, including Lautenberg Act requirements governing industry confidential business information (CBI) claims;
• the need to make full studies on which EPA bases prioritization decisions publicly accessible; and
• the need to incorporate the definition of “potentially exposed or susceptible subpopulations” from the statute, with the refinements EPA has made to it in its proposed risk evaluation rule.

Risk Evaluation

EPA appropriately proposes a rule that:

• is procedural in nature and avoids specifying science policy issues or defining related terms that are better addressed in guidance and policy statements;
• establishes a risk evaluation process that is compatible with reasonably available information and applicable deadlines;
• provides EPA with means by which to collect and require the development of information early and often in the “pipeline” of prioritization and risk evaluation;
• makes clear that chemical substances, not specific uses or subsets of uses, are to be subject to risk evaluations and risk determinations; and
• balances the need to consider all conditions of use of a chemical with the ability to:
  • apply different levels of analysis to different conditions of use; and
  • expedite particular conditions of use that clearly present unreasonable risk in order to expedite needed risk management;
• requires that a manufacturer requesting a risk evaluation must demonstrate there is sufficient information available for EPA to complete the risk evaluation for all conditions of use; and
• makes clear that risk determinations are policy decisions not subject to peer review.

However, EDF also raised concerns with or called for changes in several aspects of EPA’s proposal, including the need to:

• more clearly assert and utilize its authorities under amended TSCA to collect and require development of information needed to inform risk evaluations;
• establish a firm opportunity for public comment on risk evaluation scopes, and to provide more time for public comment on draft risk evaluations;
• add several conditions to its proposals that any issues not raised during public comment periods on risk evaluation scopes and draft risk evaluations could not be the basis for later objection or challenge, and close a loophole that would allow industry to get around this limitation;
• broaden the applicability of the provisions that implement Lautenberg Act requirements governing industry confidential business information (CBI) claims;
• clarify that EPA’s authority to revisit a risk determination only applies after final agency action based on the determination;
• delineate requirements for EPA consideration of third-party risk evaluations;
• clarify opportunities for public comment on industry requests for risk evaluations and EPA decisions on those requests;
• require that full studies on which EPA or third parties rely in risk evaluations be publicly accessible;
• in applying or updating guidance used to conduct risk evaluations (which should not be codified in this rule):
  • generally employ an aggregate approach to exposure assessment;
  • further integrate systematic review;
  • move away from EPA’s traditional margin-of-exposure approach for noncancer endpoints, as recommended by the National Academy of Sciences; and
  • avoid assigning greater weight to guideline studies over the peer-reviewed literature.

 

By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.

I noted in a recent post EDF’s grave concerns about the Regulatory Accountability Act (RAA), which passed the House on January 11.  A shorter but still very concerning version of it may soon be introduced in the Senate, modeled on last Congress’ Senate version of RAA.  This bill would add dozens of burdensome and time-consuming hurdles to the rulemaking process, effectively crippling it and eliminating the health and safety protections rules are intended to provide.  To get a feel for all of the requirements, see this dizzying RAA flow chart.

Among other things, the RAA would mandate multiple rounds of cost and impact analysis of a potentially unlimited number of regulatory alternatives; require that all major rules go through an entirely new pre-proposal step, adding months if not longer to the rulemaking process; generally require that agencies choose the lowest-cost regulatory option, regardless of whether or not it is the best option or even sufficient to meet a law’s requirements; and require lengthy and resource-intensive public hearings on many rules.  To top all this off, the bill would require an agency to finalize a proposed rule within 2 years (subject to a 1-year extension) – a timeframe almost impossible to meet now without all of the additional requirements the Act would impose; if that deadline was not met, the agency would have to start over.

There is extreme irony in the advancement of the RAA in this Congress:  Just last June, both houses of Congress passed – with overwhelming bipartisan support – major reforms to the obsolete Toxic Substances Control Act (TSCA).  The Lautenberg Act removed from the original TSCA several major constraints on the rulemaking process that had so tied the hands of the Environmental Protection Agency (EPA) that it could not even restrict asbestos, a known carcinogen that kills more than 10,000 Americans every year.  There was widespread agreement among industry and other stakeholders that those provisions of the old TSCA were detrimental or unnecessary to an efficient regulatory system and were undermining public and market confidence in the federal chemical safety system – not to mention failing to protect public health.

So here’s the irony:  The RAA would impose those same knot-tying strictures that the Lautenberg Act just got rid of – and expand them to rulemakings undertaken by any federal agency.  Let’s look at some of these crippling requirements, based on last Congress’s Senate version of the RAA:  

COST-BENEFIT CONSIDERATIONS:  As interpreted by the 5th Circuit in Corrosion Proof Fittings v. EPA, in order to regulate a chemical under the old TSCA, EPA had to conduct quantitative cost-benefit analysis (CBA) on a potentially limitless number of regulatory alternatives, regardless of whether information was available.  This requirement, coupled with the “least burdensome” requirement discussed below, is widely regarded as the most fatal flaw of the old TSCA, imposing virtually impossible evidentiary and analytic burdens on EPA.

The Lautenberg Act fixed these problems:  It requires EPA only to “consider and publish a statement on” the economic effects of a rule, and to do so only:  i) “to the extent practicable,” ii) “based on reasonably available information,” and iii) “for the 1 or more primary alternatives considered by” EPA.  It provides EPA with considerable discretion to limit the extent of analysis so that it is feasible.

Enter the RAA:  EPA and other federal agencies would have to evaluate “any substantial alternatives or other responses identified by interested persons,” regardless of how many alternatives that would be and whether or not information on them is reasonably available.  Literally anyone could tie an agency in knots merely by suggesting options that the agency would then have to analyze.  For major or high-impact rules, formal CBA would be required to be conducted on each such alternative, with virtually no discretion afforded the agency based on availability of information or practicality, and the agency would have to demonstrate that the “benefits … justify the costs.”

LEAST-COST REQUIREMENT:  The original TSCA required that EPA prove its selected regulatory requirement was the “least burdensome” of all possible options sufficient to address the problem.  The Lautenberg Act struck this requirement entirely.

Yet under the RAA, for all major or high-impact rules, EPA and other agencies would be required generally to adopt the “least costly” rule and prove that no lower-cost option is sufficient; an exception is provided where EPA could demonstrate, through even more analysis, that the additional benefits – which could not count any ancillary benefits – of a more costly rule justify the additional costs.  Yet, in contrast to costs, many benefits are very difficult to quantify or monetize and hence get short shrift in such cost-benefit analyses.

RULEMAKING STANDARD:  As just noted, TSCA originally required that EPA’s regulation to address an identified risk protect adequately against such risk using the “least burdensome requirements.”  It allowed a rule that did not actually eliminate the risk if the rule was deemed too costly.  A key reform made by the Lautenberg Act is that it precludes EPA from adopting a rule that does not eliminate an identified risk, which is to be determined without consideration of cost; then, in regulating such risk, EPA must consider costs – but only in deciding among different regulatory options each of which is sufficiently protective.  Moreover, these cost factors are only required to be considered, and EPA is not required to prove that an option meets a specific test (e.g., lowest-cost).

The RAA only generally indicates that a rule is to “meet relevant statutory objectives” – a vague term that does not require that a rule be sufficient to meet all requirements of the law that mandates or authorizes it.  In contrast, the bill’s language on cost requirements does not make clear that a rule not meeting a health-based standard would not be allowed.

REQUESTS FOR HEARINGS:  Under the old TSCA, any person could request EPA to hold a public hearing on any rule.  The Lautenberg Act struck this provision as unnecessary and overly time- and resource-intensive.  It was struck based on agreement among stakeholders that hearings were not needed and would make it impossible for EPA to meet the new law’s rulemaking deadlines.

Under the RAA, any person would be able to request a hearing on any major or high-impact rule, other than a rule “required by law” that is not a high-impact rule.  An agency would generally have to grant the request if any factual issue is in dispute, which is nearly always the case at some level.  Under this approach, any entity that wanted to drag out and obstruct a rule would have a ready opportunity to do so.

DEADLINES:  The old TSCA imposed no deadlines on EPA to identify or take action to address unreasonable chemical risks.  The Lautenberg Act imposes judicially enforceable deadlines on EPA’s proposal and finalization of risk management rules.  Critically, however, failure to meet a deadline does not relieve EPA of its obligation to complete the rulemaking.

The RAA perverts the very accountability that deadlines under the new TSCA and most federal statutes are intended to provide.  If an agency did not complete a rulemaking with 2 years of proposal (subject to a 1-year extension), the rule would be voided and the agency would have to start over – further delaying needed action to protect health or achieve a law’s key objectives.  This “reverse deadline” would apply to all rules.  Two years is highly ambitious to meet even under current rulemaking procedures, and agencies have rarely done so.  Coupled with all of the new procedural, analytic and evidentiary hurdles to rulemaking imposed by RAA, this deadline would be virtually impossible to meet and would mean virtually no regulations of any substance could be finalized.

 

Less than a year after Congress overwhelmingly adopted the Lautenberg Act – the first major federal environmental legislation enacted in over two decades – some in Congress are now threatening to impose across all of government the same paralyzing mandates that were just removed from the original TSCA by passage of the Lautenberg Act.

Lest anyone think I’m suggesting simply exempting the Lautenberg Act from the RAA, let me be clear that is no solution at all.  Congress passed the Lautenberg Act in order to restore public and market confidence in a key element of the federal safety net.  This step was also acknowledged as necessary to provide the business community with the regulatory certainty it needs to operate.  These are needs that cut across the entire federal landscape.

The very real threats – to public health, to our communities and to our environment – posed by the RAA suggests some in Congress have very short memories.

 

By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.

We have been watching with growing alarm the rapidly unfolding efforts by leadership in Congress and the Trump Administration to gut health and safety protections that provide millions of Americans with clean air, water and safe products.  Support by the American Chemistry Council (ACC) for such efforts, detailed below, gives us profound worry and deep frustration given the trade association’s support of major reforms to the Toxic Substances Control Act last year.

Many of ACC’s member companies worked for many years to move the industry towards strong federal legislation that can restore public and market confidence in the safety of their products.  Many of these companies have also been embracing sustainability commitments, and have acknowledged that a strong federal chemicals management system is critical for charting the path to a safer more sustainable future.  Those companies with a real commitment to safer chemicals and sustainability should be very alarmed that their trade association has endorsed legislation and the Trump Administration’s deregulatory executive order that would profoundly limit EPA’s and the rest of the Federal government’s ability to protect human health and the environment.

These actions by the executive and legislative branches will or would severely constrain EPA from acting to address chemical risks under the Lautenberg Act as well as other federal laws that protect our air, water, land, workplaces, schools and homes.

Here are the specifics:  

• On January 30, President Trump signed an executive order that would require, among other things, all federal agencies to repeal two regulations for every new one they issue and require that any costs (“private expenditures”) of a new regulation are fully offset by cost “savings” from such repealed rules. Benefits, including public benefits, appear to be excluded.
  • ACC immediately expressed its support for the executive order, even featuring its support prominently as its “top story” in the next day’s ACC SmartBrief.
• On January 5, the House of Representatives passed the Regulations from the Executive in Need of Scrutiny (REINS) Act. The same bill has been introduced in the Senate.  This bill would, among other things, require all new major regulations to be approved by vote in both chambers of Congress.  If either chamber did not approve any covered rule within 70 legislative days, the rule could not go into effect or be put forward for another approval vote in that Congress. This effectively gives one chamber of Congress veto power over any new significant public health and safety protection. The bill would subvert the traditional balance of power between the executive and legislative branches of government.  House Republicans added amendments requiring costs of any new regulation to be offset through repeal of existing regulations, and mandating that over the next ten years all pre-existing regulations be considered under the REINS Act and require an affirmative vote by both chambers to continue in effect.  The REINS Act would apply even to rules mandated by law, which could extend to those in progress under the Lautenberg Act as well as any rules EPA develops using its authority under the new TSCA.
  • ACC promptly issued a press release applauding the House for its passage of the REINS Act.
• On January 11, the House passed the Regulatory Accountability Act (RAA). This bill would add more than 80 burdensome and time-consuming hurdles to the rulemaking process, effectively crippling it.  Among other things, it would mandate multiple rounds of cost and impact analysis; require that every major rule go through an advanced notice of proposed rulemaking before being proposed; generally require that agencies choose the lowest-cost regulatory option; and require extensive public hearings on rules.  To top all this off, the bill would require EPA to finalize a proposed rule within 9 months (18 months for major rules) – a timeframe almost impossible to meet now without all of the additional requirements the Act would impose); if that deadline was not met, the agency would have to start over.  (A Senate version of RAA in the last Congress had a slightly less stringent deadline.)
  • ACC issued a press release a week before the vote praising the legislation and urging its prompt passage bill by the House. Among many problems with RAA, the requirements that EPA generally choose the “least cost” regulatory option, and allow any party to request a formal public hearing, on many or most regulations are paralyzing mandates that were just removed from TSCA by passage of the Lautenberg Act, but would be re-imposed should RAA pass.  So it is ironic that ACC now supports applying these requirements to TSCA as well as many other federal regulations, only months after acknowledging they were detrimental or unnecessary to an efficient regulatory system.
• Members of Congress are expected to reintroduce the Secret Science Reform Act, which was proposed in both the House and the Senate in the last Congress. This bill would require that all underlying data from any study on which EPA relied to support an action would have to be posted online and the results be able to be reproduced.  While that sounds nice, the measure would have a crippling effect because, for a host of reasons, all details of studies cannot be made public.  For example, large-scale, long-term epidemiological and other studies are not readily reproducible, some industry data are confidential, and certain data underlying some scientifically-important studies cannot be made broadly available in order to protect the privacy of test subjects or intellectual property of researchers.  This legislation has been opposed by dozens of scientific associations and universities; see here and here for examples.
  • ACC has supported this legislation in the past, and just last month used its SmartBrief to feature a story on its imminent introduction in the House, noting its support.
• Members of Congress are expected to reintroduce the Science Advisory Board Reform Act, which was proposed in both the House and the Senate in the last Congress. This bill would revise the process for selecting members of the EPA’s Science Advisory Board (SAB), which provides scientific advice to the EPA, so as to limit university and other government-funded scientists on the SAB and at the same time make it easier for industry-employed and industry-funded scientists to serve. It would also add burdensome requirements on the SAB, for example requiring it to formally respond to every comment it received, to such an extent that the SAB could be unable to carry out its mandate.
  • ACC has endorsed this legislation repeatedly in the past; see for example, here and here.

 

EDF has long strived to work with both political parties and with the private sector to find common ground and advocate for workable solutions to health and environmental problems that are also economically sustainable.  But the current Administration’s and Congress’ efforts to gut health and environmental protections are extreme and present a significant threat to Americans.  These efforts will severely undercut our ability to make progress towards a sustainable future.  To no small extent, it has been that shared vision of a safer, more sustainable future that has provided common ground upon which we came together to build an improved chemical safety system.

Companies in this industry and those that rely on its products have a choice to make:  Stick with their Washington lawyers and trade associations, and further erode the limited trust anyone has in their enterprises, or build on earlier efforts to restore public trust and move toward a more sustainable future.  The stakes are high and we are watching.

By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.

There is an extreme anti-regulatory and anti-science bandwagon moving fast through Washington, and much of the chemical industry seems to have jumped right on board.  We’re also seeing growing signs of industry pushback against even modest early actions EPA is taking to implement the Lautenberg Act, which reformed the obsolete Toxic Substances Control Act (TSCA) and passed with strong bipartisan support only last June.

Companies have every right to provide their input to EPA and argue the case for their chemicals in accordance with designated processes the agency has established for this purpose.  But resorting to tactics of obstruction and delay won’t fool anyone.  That’s the very thing that brought about the public crisis in confidence surrounding this industry in the first place.

I’ll address these concerns in this and a second post to follow.  This post will address several attempts by some in the chemical industry to thwart EPA’s efforts to implement the new TSCA.  The second post will look at the industry’s main trade association’s unabashed – indeed, boisterous – support for a new Executive Order and multiple “regulatory reform” bills moving in Congress, which it embraces despite the fact that they would impose on EPA (and other agencies’) rulemakings – including those under the new TSCA – dozens of new knot-tying strictures, some of which the Lautenberg Act just got rid of.

This suggests that some in the industry have a very short memory:  What led the industry to finally support TSCA reform was its recognition that the public, other levels of government and the market itself have little confidence in the safety of its products or the ability of government to protect people and the environment from toxic chemicals.  Any relief it sought from its initial endorsement of a stronger federal chemical safety system will quickly dissipate if industry representatives – emboldened by the current political climate – take actions to stymie implementation of the new law and to buoy executive and legislative vehicles that would bring the regulatory system to a grinding halt.

So, let’s start with a few of the battles that some in the industry are waging to undercut recent EPA actions, authorized under the new TSCA, to restrict three highly toxic chemicals – trichloroethylene (TCE), methylene chloride (MC) and N-methylpyrrolidone (NMP) – the first such actions taken under TSCA in nearly 30 years. 

Consider the following:

Various industry groups bombarded the prior Administration’s regulatory oversight office (the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget), seeking to block EPA from even proposing rules that would restrict high-risk uses of these chemicals.  For example:

• Attorneys at Bergeson & Campbell visited OIRA in December on behalf of the NMP Producers Group to argue that OIRA should force EPA to withdraw its proposed rule to restrict the use of NMP in paint strippers and start over again on the 2015 risk assessment of NMP that underlies the proposed rule.
• Later that same day, an attorney from Squire Patton Boggs accompanied the Halogenated Solvents Industry Association (HSIA) to argue the same for EPA’s proposed rule to restrict the use of MC in paint stripping and bathtub refinishing products – products documented to have killed dozens of workers and at least two consumers in recent years.

The NMP Producers Group consists of Ashland Chemical, BASF and Lyondell Chemical.  The Halogenated Solvents Industry Association consists of INEOS Chlor Americas, Inc., Occidental Chemical, Olin Chlor Alkali Products and Westlake Chemical.  Nearly all of these companies are members of the American Chemistry Council (ACC), which also met with OIRA about the MC rule.  (I’ll have more to say about ACC in my second post.)

The good news is that OIRA allowed EPA to propose the paint stripper rule (here), along with two proposed rules to ban specific uses of TCE (here and here), all of which are now out for public comment.  The bad news is that some in the industry continue to fight them in underhanded ways:

HSIA recently requested an extension of the comment periods for the TCE rules, par for the course for the industry with EPA proposed rules.  (Yesterday EPA did extend the periods, though not for as long as HSIA had requested.)  But what is so troubling about HSIA’s request is its rationale:  It is challenging the risk assessment that underlies the two proposed rules and pleads for more time to do so.

First, HISIA says it needs the additional time to be able to align its comments with a “request for reconsideration” (RFR) it intends to file after EPA rejected its earlier “request for correction” (RFC) of EPA’s 2014 TCE risk assessment.  HSIA had gone through the exact same rigmarole – an RFC followed by an RFR – attempting to topple the earlier robust toxicological review of TCE done by EPA’s Integrated Risk Information System (IRIS).

Second, HSIA is pulling one of the oldest tricks in the industry’s playbook:  arguing EPA should slow down so that HSIA can complete a study it is conducting to try to disprove a study EPA used in its TCE risk assessment.  Their tactic is truly over the top.

The study HSIA is seeking to disprove, which found that the fetuses of pregnant rats exposed to relatively low levels of TCE were at greater risk of having heart malformations, was published in 2003.  Let me repeat that date:  2003, nearly 14 years ago.  This begs the question:  What’s taken HSIA so long?  To argue that EPA should now slow down its rulemaking so HSIA can complete a study in an attempt to refute a 14-year-old study is simply ridiculous.  HSIA has repeatedly complained about this study, and EPA has repeatedly addressed its complaints; see here, for just one example.

It bears mention that EPA’s TCE risk assessment, based on dozens of published, peer-reviewed studies, documented high risks not only of fetal heart malformation but also kidney and liver damage, immunotoxicity, reproductive toxicity, as well as multiple types of cancer.

EPA has also listed TCE, MC and NMP among the first 10 chemicals to undergo full risk evaluations, and has been explicit that it is doing so in order to scrutinize additional uses not examined in the earlier assessments.  That has prompted the same industry representatives fighting the rules to argue that EPA should now withdraw the rules and fold those uses into the broader reviews it is about to undertake.  Yet Congress explicitly grandfathered in both those earlier assessments (completed in 2014 and 2015) and EPA’s authority to proceed now with regulations to restrict those specific high-risk uses; see section 26(l)(4).

Congress did so in part to help ensure EPA could take early actions to demonstrate the new law was working, rather than have no decisions be made for years after passage.  These companies are simply trying to buy time – up to 5 years or more – to keep selling their chemicals for these high-risk uses, not to mention trying to get additional bites at the apple to halt or weaken restrictions clearly needed to protect public health.

What kind of signal do these industry groups think they are sending to members of the public and to the marketplace if they succeed in delaying these rules for years?

Companies have every right to provide their input to EPA and argue the case for their chemicals in accordance with designated processes the agency has established for this purpose.  But resorting to tactics of obstruction and delay won’t fool anyone.  That’s the very thing that brought about the public crisis in confidence surrounding this industry in the first place.

My next post will discuss the vocal support by representatives of the chemical industry for an anti-regulatory executive order and multiple “regulatory reform” bills moving in Congress that would impose on EPA and other agencies dozens of new strictures, some of them the same shackles that the Lautenberg Act just got rid of.

 

By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.

The Environmental Protection Agency (EPA) is publishing a notice in tomorrow’s Federal Register affirming that the Lautenberg Act requires upfront substantiation of all confidential business information (CBI) claims submitted under the Toxic Substances Control Act (TSCA), except for certain claims that the law exempts from substantiation requirements.

While EPA initially took a narrower approach on an interim basis in the flurry of activity following last June’s passage of the Lautenberg Act, today’s notice supersedes that earlier approach and clarifies the upfront substantiation requirement.

In today’s notice, EPA notes the strong support for its clarification in the statute itself as well as in the legislative history in both Houses of Congress leading up to its final passage.

This clarification hopefully won’t be controversial:  A broad swath of stakeholders have voiced support for the upfront substantiation requirement and have noted that it is a key reform made by the new law.

In November the American Alliance for Innovation (AAI) sent a letter to EPA Administrator McCarthy signed by more than 60 trade associations – including the American Chemistry Council, the Society of Chemical Manufacturers and Affiliates, the American Cleaning Institute, the American Petroleum Institute and the Consumer Specialty Products Association – noting that under the Lautenberg Act “[c]laims for CBI protection must be accompanied by an upfront substantiation.”

And back in 2013, the American Chemistry Council provided responses to questions for the record posed by then-Congressman Henry Waxman that stated that “[i]mprovements to the CBI provisions in a modernized TSCA should include … [r]equiring upfront substantiation of the CBI claim.”  The same response letter noted that:  “The American Chemistry Council and its members support up-front substantiation of CBI claims.”

Importantly, EPA’s notice makes clear that the substantiation requirement applies to all non-exempt CBI claims made since passage of the law last June, although EPA is providing an exceedingly generous length of time for companies to comply.

Given the law’s 90-day deadline for EPA review of CBI claims, there are strong policy reasons for requiring upfront substantiation of CBI claims:

• First, EPA’s own experience based on recent chemical reporting it has required demonstrates that requiring upfront substantiation reduces the number of CBI claims asserted. That means fewer claims EPA has to review and a greater likelihood that claims are only asserted for information that warrants protection.
• Second, when those reviews are conducted, EPA will already have the information it needs to review the claim instead of having to request it from the company, wasting precious days or weeks of the 90-day review period.

By Lindsay McCormick

Lindsay McCormick is a Project Manager.  

Yesterday, EPA proposed a rule to ban methylene chloride and either ban or restrict the use of N-methylpyrrolidone in paint stripping products, subject to certain national security exemptions. This proposal is the third such proposed action by the agency in the past month (see here and here). Below, find a short description of these chemicals and EPA’s proposed actions.

Methylene chloride

Methylene chloride (also known as dichloromethane, or DCM) is carcinogenic, neurotoxic, and acutely lethal. It is produced and imported in huge amounts – 261 million pounds annually.

According to EPA, DCM’s short-term effects include “dizziness, incapacitation, and, in some cases, death.” As of 2012, OSHA had linked DCM to over 50 worker deaths nationwide since the mid-1980s.  Many of these deaths have been associated with the use of DCM-based paint strippers in confined spaces to refurbish bathtubs. EPA’s 2014 risk assessment identified at least 15 such reported cases of worker deaths, associated with 10 different DCM-containing paint stripper products. Effects of long-term exposure to DCM include liver toxicity, liver cancer, and lung cancer.

EPA’s risk assessment demonstrated that current levels of exposure to DCM-containing paint strippers pose unacceptably high acute and chronic risks to workers and occupational bystanders as well as acute risks to consumers and residential bystanders.

Given these high risks, we applaud the Agency’s proposal to “prohibit manufacture (including import), processing, and distribution in commerce” for use as a paint stripper using its section 6 authority under the recently reformed Toxic Substances Control Act (TSCA). EPA’s current proposal does not, however, include commercial furniture refinishing, even though it has concluded that such uses present unreasonable risks; EPA notes it plans to issue a separate proposal after collecting more information on the impacts of regulating such uses to inform its selection of risk management actions.

N-methylpyrrolidone

NMP is commonly used as a DCM replacement, yet it too presents significant risks. Health impacts of NMP include developmental and reproductive toxicity, neurotoxicity, immunotoxicity, and liver and kidney toxicity. It is also produced and imported in large volumes (184 million pounds annually).

As we blogged about previously, EPA demonstrated in its 2014 NMP risk assessment that current levels of exposure to NMP-containing paint strippers pose an unacceptably high risk of adverse developmental toxicity (fetal effects) associated with acute and chronic exposure to female workers and consumers of childbearing age. EPA found that exposure to NMP-based paint strippers in women of childbearing age beyond four hours per day presents risks that cannot be mitigated from use of protective gear such as gloves and respirators.

In EPA’s proposed rule, it is requesting comment on two approaches to address risks of NMP.  As stated in its press release:

One approach would prohibit manufacture (including import), processing, and distribution in commerce of NMP when used as a paint remover, as well as require various notification measures on the restrictions to downstream processors and users. The other approach would put in place a combination of requirements to address unreasonable risks, including limiting the amount of NMP in paint remover products [to 35% by weight], providing warning labels for consumers, and requiring workers to wear specialized gloves and other equipment.

EDF is very concerned about anything less than a ban on this use of NMP, given its demonstrated high risks and given that such labeling and protective equipment requirements are typically used already but are insufficient to mitigate the risks. In the proposed rule, EPA notes the limited effectiveness of labels, especially under real-world conditions.  Further, reliance on personal protective equipment (PPE) is often subject to major practical limitations and at best mixed effectiveness. As recently described by OSHA:

…to be effective, respirators must be individually selected, fitted and periodically refitted, conscientiously and properly worn, regularly maintained, and replaced as necessary. The absence of any one of these conditions can reduce or eliminate the protection the respirator provides.

Respirator effectiveness ultimately relies on the practices of individual workers who must wear them. … Furthermore, respirators can impose substantial physiological burdens on workers, including the burden imposed by the weight of the respirator; increased breathing resistance during operation; limitations on auditory, visual, and olfactory sensations; and isolation from the workplace environment.

OSHA therefore continues to consider the use of respirators to be the least satisfactory approach to exposure control.

Addressing DCM and NMP simultaneously in a TSCA section 6 rulemaking makes a lot of sense.  As NMP is a common substitute for DCM in paint strippers, this approach will help prevent regrettable substitution – where one bad chemical is simply replaced with another. However, this strategy will be severely hampered if the final rule relies only on NMP restrictions that fall short of a ban.

Putting aside the ample public health reasons to ban NMP for paint stripping uses, EPA’s economic analysis demonstrates that it would cost industry far more (on the order of $100 million) to implement such concentration, labeling, and PPE requirements than to comply with a simple ban.

EDF intends to submit comments on these aspects of the proposed rule, and encourages others to do the same. Comments will be accepted at www.regulations.gov (docket: EPA-HQ-OPPT-2016-0231) until 90 days after the rule’s publication in the Federal Register, which is expected next week.