EDF Health

EPA’s latest move to deflect criticism of its TSCA risk evaluations: Muzzle its science advisors

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

Readers of this blog know that Environmental Defense Fund (EDF) has voiced strong opposition to a number of decisions made by the Environmental Protection Agency (EPA) that aim to limit the risks it finds when evaluating the safety of chemicals under the Toxic Substances Control Act (TSCA).

These decisions include:

  • excluding from its analysis known human and environmental exposures to a chemical, based on unwarranted assumptions that those exposures are adequately managed by other statutes;
  • claiming without support that workers are protected by assuming universal and universally effective use of personal protective equipment throughout chemical supply chains and the adequacy of OSHA regulations that either don’t apply or are decades out of date;
  • arbitrarily loosening EPA’s longstanding risk standards governing when cancer incidences are deemed unacceptably high; and
  • choosing not to exercise its enhanced authorities under TSCA to require submission of robust information on chemicals’ hazard and exposures, resorting instead to questionable assumptions and relying on voluntarily submitted industry data that are unrepresentative or of poor or indeterminate quality.

Through these decisions, EPA increases the likelihood that it will either not find unreasonable risk and thereby avoid regulating the chemical, or if that can’t be accomplished, find risks that are low enough that it can impose few restrictions, thereby burdening industry as little as possible.

In response to each of these decisions, EPA has received dozens of highly critical comments on its draft risk evaluations from state and local governments, labor and health groups, environmental NGOs and members of the scientific community.  And in the first several peer reviews conducted by its Scientific Advisory Committee on Chemicals (SACC), many of the scientists voiced quite similar concerns during the committee’s public meetings (as of yet, final peer review reports have not been issued).

Rather than address the problems, EPA has adopted a new tactic to stifle the criticism, one that is quite chilling (literally and figuratively):  It is telling the SACC that these issues are off-limits to the peer reviewers because they represent policy decisions that are beyond the charge given to the SACC.  This is beyond the pale, for several reasons.  Read More »

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EDF comments flag serious flaws in EPA’s draft risk evaluation for 1-Bromopropane

This week, EPA held its Science Advisory Committee on Chemicals (SACC) meeting to peer review its draft risk assessment on 1-bromopropaneone of the first 10 chemicals being evaluated under the reformed Toxic Substances Control Act (TSCA).

EDF provided both oral comments and written comments to the SACC, raising the following issues:

  1. EPA inappropriately and illegally excludes all exposures to the general population from releases to air, water and land based on the unsupported assumption that other statutes adequately address the exposures;
  2. EPA has failed to evaluate the risk to consumers of developing cancer from acute 1-BP exposure;
  3. EPA errs in deeming a 1 in 10,000 cancer risk level reasonable for workers;
  4. EPA lacks access to full studies and relies only on summaries, prepared by industry, of limited aquatic toxicity testing to conclude 1-BP presents no unreasonable risks to the entire environment; and
  5. EPA overstates OSHA requirements and erroneously assumes that workers always use appropriate personal protective equipment. Yet in 2018 alone, OSHA cited 2,892 violations of the respiratory protection standard identified in 1,281 separate inspections, and such violations were the fourth most common type of violation.

Recently EPA has publicly stated that a number of the topics above are policy decisions outside the SACC’s charge (particularly, 1, 3 and 5). In our comments, EDF strongly disagreed, noting that all three decisions have major direct scientific consequences, and clearly lead EPA to underestimate the chemical’s risk – to the environment, the general population, workers, and vulnerable subpopulations.

For our full set of oral and written comments, see here.


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EPA needs to stop misleading the public and its peer reviewers about the data it has obtained from the European Chemicals Agency

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

In numerous assessment documents issued by the Environmental Protection Agency (EPA) developed in its implementation of the Toxic Substances Control Act (TSCA), EPA cites as a source the European Chemicals Agency (ECHA).  ECHA is the agency that administers the European Union’s (EU) REACH Regulation, which (unlike TSCA) requires the registration of chemicals in commerce by companies that wish to continue to produce and use the chemicals in the EU.

When companies register chemicals under REACH, they are required to develop and submit a “dossier” of certain information on production and use as well as on physical-chemical properties, fate, hazard, exposures and risks.  ECHA then makes information available on its website.

In its draft risk evaluations for the first 10 chemicals undergoing evaluations under TSCA, as well as in some of its support documents for high-priority substance designations under TSCA, EPA has heavily relied on these dossiers.  But in doing so, EPA has grossly mischaracterized the source and nature of the data it references as coming from ECHA.

EDF has been raising concerns about EPA’s mischaracterizations for some time now (see section 1.E of our comments on EPA’s draft risk evaluation for 1,4-dioxane), but they persist.  And as recently as yesterday, members of the peer review panel reviewing EPA’s draft documents have been led by EPA statements and citations to assume a degree of completeness and government review of these data that is simply false.

EPA needs to immediately cease and desist in its mischaracterizations.  Read More »

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1,4-dioxane: The case of the disappearing tumors

Rachel Shaffer is a consultant.  Richard Denison, Ph.D.is a Lead Senior Scientist.

As we highlighted in a previous post, EDF filed extensive comments on EPA’s draft risk evaluation for 1,4-dioxane. Among the many concerns we raised was a decision by the Trump EPA to completely dismiss female mouse liver cancer data used by EPA’s Integrated Risk Information System (IRIS) program as key inputs to its cancer risk modeling conducted in 2013. The Agency appears to be trying every trick in the trade – such as excluding most exposure sources and routes – in its effort to conclude that the chemical presents few or no risks to human health or the environment. Read on for more on this latest one. Read More »

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Should EPA grant industry’s hypocritical request to now address 1,4-dioxane’s risks as a byproduct, it must meet a number of conditions

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

Environmental Defense Fund (EDF) submitted extensive comments last week to the Environmental Protection Agency (EPA) that raise numerous serious concerns with EPA’s draft risk evaluation for the likely human carcinogen 1,4-dioxane.  EDF’s comments are available here.

I want to use this post to highlight one of the many issues:  For years, the industry has urged EPA not to include 1,4-dioxane’s presence as a byproduct in various formulated products within the scope of its risk evaluation for the chemical; see comments specific to 1,4-dioxane from the American Cleaning Institute, Procter & Gamble, and the Household & Commercial Products Association; and more general comments urging exclusions for byproducts and “trace levels” from the American Chemistry Council and the Consumer Specialty Products Association Comment.

Not surprisingly, the Trump EPA’s draft risk evaluation for 1,4-dioxane did just that, a major problem EDF objected to on legal and scientific grounds.

Then in late July, the industry abruptly reversed itself.  A comment letter submitted to EPA by the American Cleaning Institute and the Grocery Manufacturers Association says the industry has changed its mind and is now calling on EPA to include 1,4-dioxane’s presence as a byproduct as a condition of use in its risk evaluation.

Why the shift?  At this late hour it has dawned on the industry groups that any final action by the agency on the chemical that excludes 1,4-dioxane’s presence as a byproduct as a condition of use in its risk evaluation will not preempt states from acting to regulate this condition of use.

The industry’s hypocrisy aside, if EPA decides to grant this industry request, which has arrived long after EPA initiated the risk evaluation process, EPA should do so only subject to conditions that are critical to meet if its decision and risk evaluation are to maintain any semblance of credibility:

  • EPA needs to use its mandatory information authorities to require the submission and development of relevant information on the presence of 1,4-dioxane as a byproduct in industrial, commercial and consumer materials and products, as input into a revised draft risk evaluation.
  • EPA must promptly make all such information it receives public, subject only to redactions of information claimed confidential by the submitters that EPA determines meet all applicable requirements of TSCA section 14. It should be noted that much of the relevant information will constitute health and safety information that is not eligible for protection under section 14 and must be made public.
  • EPA needs to carefully and thoroughly develop and fully integrate an analysis of the potential exposures and risks arising from the presence of 1,4-dioxane as a byproduct into all aspects of its risk evaluation, given that inclusion of the presence of 1,4-dioxane as a byproduct will affect all of the exposure and risk estimates EPA has examined in the current draft risk evaluation.
  • EPA must publish a revised draft risk evaluation for public comment, providing the public with ample time to review the new draft and develop meaningful comments.
  • EPA must subject its revised draft risk evaluation to full peer review by the Scientific Advisory Committee on Chemicals (SACC), providing the committee with ample time to review the new draft and develop meaningful comments.

Any credible evaluation of the contribution to 1,4-dioxane’s overall health and environmental risks due to its presence as a byproduct must be based on complete, reliable information that is publicly accessible, and must reflect input from both the public and expert peer reviewers.  For EPA to do anything less will simply cast yet more doubt on its trustworthiness and independence from industry interests.


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Taking on the lead challenge: State and community action accelerates across the country

Sam Lovell, Project Manager and Tom Neltner, J.D., Chemicals Policy Director.

In January, we reported on the tremendous progress made by states and communities in 2018 to replace lead service lines (LSLs) – the estimated 6.1 million lead pipes across the country that connect homes and other buildings to the water main under the street. At that time, our tracker stood at 95 communities and 16 states working to replace LSLs.

Half a year later, and the total number of communities (including municipalities and water utilities) EDF has learned of that are leading the way has swelled to 181.[1]

  • 7 communities located in Massachusetts, Michigan, Oregon, South Dakota, Washington, and Wisconsin have publicly announced that they completely replaced all known LSLs.
  • 108 communities have publicly set a goal of eliminating LSLs on public and private property, totaling more than 381,000 LSLs. Nearly ¾ of these communities are served by the investor-owned utility, American Water’s, operations in Missouri (34 communities), Indiana (27 communities), and Pennsylvania (19 communities). For the remaining states, Wisconsin is leading the way with 11 communities followed by Michigan with five; Colorado and Massachusetts with two; and Arizona, Arkansas, Montana, New Jersey, and Washington each with one.
  • 66 communities are publicly taking steps to replace LSLs but have not yet set a goal of full replacement. These communities include 15 in Wisconsin; 12 in New York; 11 in Illinois; seven in Michigan and Massachusetts; five or fewer in Colorado, Iowa, Kentucky, Minnesota, New Jersey, Ohio, Pennsylvania, Rhode Island, Texas, Vermont, and Virginia; and Washington, D.C.

Read More »

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