EDF Health

Selected tag(s): risk evaluation

Exhibit PV29: Why this EPA can’t be trusted to forthrightly assess chemical risks under TSCA

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

I blogged last week about the Environmental Protection Agency’s (EPA) illegal and hypocritical decision to deny the public access to health and safety studies conducted on the first chemical to undergo a risk evaluation under the reformed Toxic Substances Control Act (TSCA).  In its draft risk evaluation, now out for public comment, EPA relied on these secret studies to assert that the chemical, commonly known as Pigment Violet 29, or PV29, is safe, so EPA’s denial of public access matters a great deal.

EPA asserts that these studies are entitled to protection as confidential business information (CBI) under TSCA, when in fact TSCA explicitly does not extend CBI protection to such studies.  The only health and environmental information on this chemical that is public are brief summaries of those studies that were prepared by the companies that make the chemical, and were submitted to the European Chemicals Agency (ECHA) when the chemical was registered under the European Union’s REACH Regulation.  (EPA erroneously states that the studies were “summarized by ECHA.”  This is simply not the case:  Registrants, not ECHA, develop the summaries that are then made available in the registration “dossiers” for REACH chemicals.)

As we review EPA’s draft risk evaluation for PV29, we are finding that EPA’s assertions cannot be trusted even about what these summaries state are the findings of the underlying studies.  I’ll discuss one such case in this post.   Read More »

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EDF submits extensive comments critical of EPA OPPT’s TSCA systematic review document

Ryan O’Connell is a High Meadows Fellow; Jennifer McPartland, Ph.D., is a Senior Scientist.

Last night, Environmental Defense Fund (EDF) submitted critical comments on EPA’s Office of Pollution Prevention and Toxics’ (OPPT) “systematic review” document that OPPT is using to evaluate chemicals’ risks under the Toxic Substances Control Act (TSCA).

Systematic review, a hallmark of the clinical sciences, employs structured approaches to identifying, evaluating, and integrating evidence in a manner that promotes scientific rigor, consistency, transparency, objectivity, and reduction of bias.

Unfortunately, OPPT’s systematic review document deviates dramatically from the best practices in systematic review—practices developed over decades based on empirical evidence and experience in application. OPPT’s approach also significantly diverges from recent recommendations of the National Academy of Sciences (see here and here).

Read More »

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EDF files extensive comments critical of EPA’s problem formulations for the first 10 chemicals being reviewed under TSCA

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

Last night, Environmental Defense Fund (EDF) submitted more than 200 pages of comments providing a detailed critique of each of the “problem formulations” EPA issued in June for the first 10 chemicals in commerce undergoing risk evaluations under the Toxic Substances Control Act (TSCA).  EDF also delivered 45,000 comments to EPA from members of the public across the country echoing our concerns.

The EPA documents lay out the scope of each of the risk evaluations EPA will conduct.  They are highly flawed and deviate in numerous ways both from what TSCA requires and from use of the best available science.   Read More »

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Pruitt EPA Illegally and Dramatically Undermines Authority to Limit Dangerous Chemicals under Reformed Chemical Safety Law

EPA today revealed its severely flawed approach to reviewing the risks to health and the environment posed by the first 10 chemicals being evaluated under the newly reformed chemical safety law, the Toxic Substances Control Act (TSCA).  These chemicals were selected in 2016 because of their potential dangers to the health of American families, but the Pruitt EPA has chosen to ignore many sources of exposure to the chemicals and, in doing so, will severely underestimate their actual risks.

“EPA is both ignoring the law and endangering public health.  The approach it is taking – designed by an appointee who came straight from the chemical industry’s lobbying arm – ignores millions of pounds of toxic pollution,” said Dr. Richard Denison, EDF lead senior scientist.  “Pruitt’s EPA won’t examine the real extent of exposures to these chemicals – and that will put at risk the lives and health of Americans.”

An analysis by Environmental Defense Fund reveals that EPA will ignore more than 68 million pounds of seven of these 10 chemicals released to the nation’s air, water, and land every year.  Among the chemicals are known killers such as asbestos and other toxic chemicals such as trichloroethylene (TCE) that cause cancer and are linked to developmental and neurological disorders.

Download or view the above table at this link.   Read More »

Posted in Health Policy, TSCA Reform / Also tagged | Comments are closed

EDF joins Opening Brief in legal challenge to EPA’s Prioritization and Risk Evaluation Rules

Late yesterday, EDF joined fourteen other Petitioners in filing an Opening Brief in our case challenging EPA’s Prioritization Rule and Risk Evaluation Rule.  The Brief was filed with the U.S. Court of Appeals for the Ninth Circuit.

Our Brief argues that the Toxic Substances Control Act (TSCA), as amended by the Lautenberg Act, requires EPA to comprehensively evaluate a chemical’s hazards and exposures arising from all of its “conditions of use,” a term defined under TSCA as encompassing the chemical’s entire lifecycle from manufacturing and processing to use and disposal.  EPA is then to make a holistic determination of whether the chemical presents an unreasonable risk of injury to human health or the environment, including to potentially exposed or susceptible subpopulations.  EPA’s Rules violate this requirement because EPA asserts unfettered discretion to exclude known or reasonably foreseen exposures and conditions of use from consideration, thereby ignoring potentially important contributors to a chemical’s overall risk.  As a result, the Rules threaten to leave the public—especially vulnerable groups like children, pregnant women, and workers—as well as the environment inadequately protected from the potential risks posed by the thousands of chemicals to which we are exposed every day.

EPA’s response brief in the case is due to the Court on July 5, 2018.  As this litigation proceeds, you can find more information – including all significant legal documents – on EDF’s website.

 

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

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 »

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