EDF Health

Selected tag(s): Lautenberg Act

Known knowns and known unknowns: Getting an accurate, transparent and up-to-date TSCA chemical inventory

By / Published: March 29, 2017

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.   Read More »

Posted in Health policy, TSCA reform / Also tagged , | Comments are closed

Getting the framework right for the new TSCA: EDF comments filed on key EPA proposed rules

By / Published: March 21, 2017

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:

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.   Read More »

Posted in Health policy, Regulation, TSCA reform / Also tagged , , | Comments are closed

Congress just fixed TSCA – yet is now gearing up to re-impose the worst flaws of the old law across the entire Federal government

By / Published: March 8, 2017

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:   Read More »

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No, chemical industry, you can’t have your cake and eat it too (Part 2)

By / Published: February 10, 2017

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

[Part 1 here]

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:   Read More »

Posted in Health policy, TSCA reform / Also tagged | Comments are closed

No, chemical industry, you can’t have your cake and eat it too (Part 1)

By / Published: February 9, 2017

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.

[pullquote]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.[/pullquote]

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.  Read More »

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Getting it up front: EPA clarifies substantiation requirements for CBI claims under the new TSCA

By / Published: January 18, 2017

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.
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