EDF Health

Selected tag(s): 1-Bromopropane

Another EPA risk evaluation grossly understates risks, this time of 1-bromopropane

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

On Friday EDF filed detailed comments with the Environmental Protection Agency (EPA) critical of its draft risk evaluation for the carcinogenic solvent, 1-bromopropane (or 1-BP).  As was the case with 1,4-dioxane, EPA has grossly understated the risks from exposure to this chemical, for both cancer and non-cancer health effects.  EPA has also inappropriately dismissed human studies that show neurological effects at 1-BP exposures lower than EPA assumed to be safe.

While the draft risk evaluation did find that some uses of 1-BP present unreasonable risks, even in those cases it understated the extent of the risk – which, if not ameliorated, means that any regulation it subsequently promulgates will be under-protective.

EPA has also abdicated its responsibility under the Toxic Substances Control Act (TSCA) to identify and evaluate the risks the chemical presents to consumers and the general population by excluding from its risk evaluation conditions of use and exposures that are known or reasonably foreseen.  EPA has not met its mandatory duty under TSCA to thoroughly identify and evaluate the risks to vulnerable subpopulations.  EPA has utterly failed to utilize the enhanced authorities Congress granted it in 2016 to ensure that it has or obtains robust information on 1-BP’s uses, hazards and exposures, resulting in serious information and analytic gaps and deficiencies that severely undermine the scientific quality of its risk evaluation.

Below we list major concerns that EDF addressed in our comments (with references to the corresponding section of the comments).  Read More »

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An unwarranted assumption run amok: How the Trump EPA grossly understates the risks of 1-Bromopropane to workers

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

We have blogged repeatedly about the ways in which the Trump EPA is compromising workers’ health, either by failing to identify the significant risks they face, or wishing away the risks EPA does identify by erroneously assuming that existing industry practices and OSHA regulations are taking care of any possible problem.

If EPA uses PPE assumptions to erase unreasonable risks, then it won’t regulate the chemical and will forgo its only opportunity to ensure that PPE is actually used.  If EPA does find unreasonable risk even with its PPE assumptions, by understating the magnitude of that risk, any subsequent regulation EPA promulgates will be underprotective.

All of this is contrary to the mandate Congress gave EPA when it reformed the Toxic Substances Control Act (TSCA) in 2016.  The new TSCA strengthens EPA’s authority and mandate to protect workers, explicitly identifying them as a “potentially exposed or susceptible subpopulation.”  But under this administration, EPA has instituted many policies and practices that undercut the protections afforded workers under TSCA.

A key policy driver is EPA’s assertion – absent any empirical evidence to support it – that workers throughout chemical supply chains will always wear effective personal protective equipment (PPE).  There are many legal, scientific and policy problems with this assumption, and it is only one of many questionable aspects of the Trump EPA’s handling of risks to workers.

But just how big a difference does this assumption make?  Let’s look at the agency’s draft risk evaluation for the carcinogenic solvent 1-Bromopropane (1-BP), which is currently undergoing public comment and peer review.  Read More »

Posted in EPA, Health Policy, Health Science, Regulation, TSCA Reform, Worker Safety / Also tagged | Comments are closed

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 »

Posted in EPA, Health Policy, Health Science, Industry Influence, Regulation, TSCA Reform / Also tagged | Comments are closed

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.

 

Posted in EPA, Health Policy, Health Science, Regulation, TSCA Reform / Tagged | Comments are closed

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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