EDF Health

A primer on the new Toxic Substances Control Act (TSCA) and what led to it

By / Published: April 3, 2017

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 what led to the new law and describes in some detail the key reforms Lautenberg made to the original TSCA and how the law works.

The primer is intended to serve as an introduction and guide to the new law for those that haven’t been steeped in the details and provides our perspective on the key provisions.  It also discusses those aspects of the new law that may be of particular interest and relevance to the public health community.

For the latest on the state of play on implementation, please keep an eye on our blog.

Also posted in TSCA reform / Tagged | Comments are closed

EPA’s ban on high-risk uses of trichloroethylene needs to get over the finish line

By Jennifer McPartland / Published: March 31, 2017

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:   Read More »

Also posted in Health science, Regulation, TSCA reform / Tagged , | Comments are closed

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 »

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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 »

Also posted in Regulation, TSCA reform / 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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Dad’s lead-laden hair dye could impact the whole family: FDA to consider barring lead compound in widely-used men’s hair dyes

By Jack Pratt / Published: February 27, 2017

Jack Pratt is Chemicals Campaign Director

Today, EDF joined a group of advocates in filing a petition that could force a ban on lead in hair dyes. Over the last several decades, we have gone to great lengths to reduce lead exposure—from eliminating the use of lead in gasoline, to tackling legacy uses in paint and water pipes. Yet, somewhat incredibly, lead is still permitted in hair dyes in the United States. Unfortunately, the evidence indicates that use can have an impact not only on the men who use it (it is seemingly exclusive to men’s dyes) but can have an impact on kids in the house too. That’s why FDA should take action and reverse their decades-old approval of lead in hair dyes.

Read More »

Also posted in FDA, General interest, Lead, Regulation / Tagged , | Comments are closed