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equipment throughout chemical supply chains and the adequacy of OSHA regulations that either don’t apply or are decades out of date;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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Trump EPA caves again to industry demands on new chemicals, and workers pay the price

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

Isocyanates are nasty chemicals, including when they are left over as residuals after manufacturing other chemicals.  Here are the kinds of risks they pose, according to the National Institute for Occupational Safety and Health (NIOSH):

Isocyanates are powerful irritants to the mucous membranes of the eyes and gastrointestinal and respiratory tracts.  Direct skin contact can also cause marked inflammation.  Isocyanates can also sensitize workers, making them subject to severe asthma attacks if they are exposed again. There is evidence that both respiratory and dermal exposures can lead to sensitization.  Death from severe asthma in some sensitized subjects has been reported.

In prior reviews of new chemicals under the Toxic Substances Control Act, EPA has repeatedly indicated that “[i]socyanate exposure has been identified as the leading attributable cause of work-related asthma, and prevalence in the exposed workforce has been estimated at 1-20 percent.”

Both NIOSH and EPA have raised even greater concern over activities involving spray application of chemicals containing isocyanates.  In 2006, NIOSH issued a rare alert calling for workers to undergo medical surveillance and wear high-efficiency respirators and gloves when engaged in such activities.

Even in the recent past, when reviewing new chemicals containing isocyanate residuals, EPA has typically (1) issued a consent order subjecting the company submitting the chemical for review to multiple conditions in order to limit workplace inhalation exposures to the residuals, and (2) followed up with a Significant New Use Rule (SNUR) that extends those conditions to other companies, requiring them to notify EPA prior to engaging in any activity that exceeds those workplace limits.  And the only case since TSCA was amended in 2016 where EPA found a new chemical “presents an unreasonable risk” – as opposed to the more common, lower-bar finding that it “may present an unreasonable risk” – involved residual isocyanates present after manufacture of two new chemicals.

In such cases EPA has imposed some combination of three types of conditions on manufacture of such chemicals:  prohibitions on activities that could generate inhalable forms of the chemical and result in inhalation exposures; strict requirements for the use of high-efficiency respirators and gloves; and a strict limit on the amount of isocyanate residuals allowed to be present in the new chemical, typically in the range of 0.1% to 0.2%.

So it is quite disturbing to see how EPA has dealt with the most recent such new chemical for which EPA has issued its final decision – which requires that companies employ NONE of these protections.  Read More »

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Trump EPA grossly understates workers’ risks to 1,4-dioxane while ignoring those to the general public

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

On Friday, the Environmental Defense Fund (EDF) filed extensive comments on a draft risk evaluation for the likely human carcinogen 1,4-dioxane EPA issued on July 1.  While the formal public comment period runs until August 30, Friday was the deadline EPA set for comments if submitters want them to be considered by the Scientific Advisory Committee on Chemicals (SACC), which will be conducting peer review of the draft risk evaluations for this chemical and another, the flame retardant hexabromocyclododecane (HBCD), next week.

In its draft risk evaluation for 1,4-dioxane, the Environmental Protection Agency (EPA) has grossly understated the risks that workers and the environment face from exposure to the chemical.  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 identify and evaluate the risks to vulnerable subpopulations, falsely asserting there is no evidence that certain subpopulations are or may be more susceptible to adverse effects from exposure to the chemical.  EPA has utterly failed to utilize the enhanced authorities Congress granted it in 2016 to ensure that it has or obtains robust information on 1,4-dioxane’s uses, hazards and exposures, resulting in serious information and analytic gaps and deficiencies that severely undermine the scientific quality of its risk evaluation.

EDF’s comments raised numerous major concerns with EPA’s draft.  Among them are the following (see the noted section of the full comments for the details):

  • EPA has ignored evidence that some subpopulations are or may be more susceptible to 1,4-dioxane exposures than the general population (see section 1.A).
  • EPA has distorted OSHA requirements and over-relied on personal protective equipment, ignoring its real-world limitations (see section 1.B).
  • EPA has, without scientific basis, sought to sow doubt on the use of a linear, non-threshold model for 1,4-dioxane’s carcinogenicity, an approach that reflects longstanding agency policy and consensus in the scientific community (see section 1.D).
  • EPA has dismissed the liver tumors observed in female mice in the key oral cancer study it uses to extrapolate dermal cancer risks. Its insufficient rationale ignores the IRIS program’s basis for including these tumors and its determination that they are the most sensitive endpoint, which has been affirmed through peer review.  As a result, cancer risk is significantly understated, a concern also noted by the New Jersey Department of Environmental Protection. (See section 1.E.ii.)
  • EPA has excluded all exposures and risks to consumers (and to workers from at least one use), based on 1,4-dioxane’s presence in such products as a byproduct rather than being intentionally used, a distinction without any basis in science (see section 2.A).
  • EPA has excluded from its risk evaluation all general population exposures to 1,4 dioxane, based on EPA’s unsupported assertion that existing regulatory programs under other statutes EPA administers have addressed or are in the process of addressing potential risks of 1,4-dioxane in all media pathways (see section 2.B).
  • In several instances, EPA’s decisions are inconsistent with Agency guidelines (see section 4.B.i).
  • EPA fails to consider combined exposures to workers from different routes and sources (see section 4.B.ii).
  • EPA has significantly understated the extent of risks to workers it has identified (see section 5).
  • EPA’s “expectation” of compliance with existing laws and standards as a basis for not finding unreasonable risk is unwarranted (see section 6.A).
  • EPA finds no unreasonable risk even when the high-end risk exceeds relevant benchmarks, an approach that is not adequately protective (see section 6.B).
  • EPA’s allowance of a 1 in 10,000 cancer risk for workers is a major and unwarranted deviation from longstanding agency policy and practice to regulate upon finding cancer risks on the order of 1 in 1 million (see section 6.C).
  • EPA’s systematic review to support the risk evaluation is flawed and not reflective of best practices (see section 7).

 

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Hey Trump EPA, your extreme bias in favor of the chemical industry is showing again

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

[See UPDATE in brackets below.]

The Trump Environmental Protection Agency (EPA) has just released drafts of two more chemical risk evaluations it has conducted under the Toxic Substances Control Act (TSCA).  One is for the likely human carcinogen and neurotoxicant 1,4-dioxane, which contaminates public water systems serving more than 7 million Americans in 27 states at levels exceeding the level EPA has traditionally (until now) aimed to meet for general population exposures.  The other is for the flame retardant hexabromocyclododecane, or HBCD, a persistent, bioaccumulative and toxic (PBT) chemical – toxic to human development and highly acutely and chronically toxic to aquatic organisms – that has been banned or heavily restricted in most of the rest of the developed world.

As might have been expected of the Trump EPA, the draft risk evaluations wholly exonerate HBCD and largely do so for 1,4-dioxane.  Especially in the latter case, EPA achieves its improbable finding through quite a sleight of hand:  EPA simply excludes most exposures to the chemical from the scope of its risk evaluation.

Trump EPA political appointees have repeatedly argued that the agency needs to be doing a better job at “risk communication.”  I guess we now know what that means.

Once finalized, EPA’s determinations that these chemicals “do not present an unreasonable risk” will mean it has no obligation or authority to impose any restrictions on their manufacture, processing, distribution, use, recycling or disposal.

We will be looking at these documents more closely in the very limited time EPA has provided for the public to review and comment on them.  But I want to draw attention right off the bat to a telling aspect of how the Trump EPA has presented its risk determination for 1,4-dioxane.

Read More »

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EDF files comments on two EPA proposals affecting EPA’s and the public’s access to chemical information under TSCA

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

Yesterday Environmental Defense Fund (EDF) filed comments on two EPA proposals (here and here) that will have major impacts on what chemical information EPA obtains and the public has access to.  While EPA risk evaluations and risk management actions (such as they are) often garner the lion’s share of stakeholder attention, the 2016 amendments to the Toxic Substances Control Act (TSCA) also made sweeping changes to EPA’s authority and duty to obtain better information on chemical uses, hazards and exposures, and to rein in rampant industry claims aimed at keeping much of that information hidden from public view.

As readers of this blog know, the extent of chemical information available to the agency and disclosed to the public has been a major point of controversy under the Trump EPA.  Three years after passage of the reforms to TSCA, EPA has yet to use its expanded information authorities even once, despite major data gaps for the chemicals it is prioritizing and evaluating.  In some cases, EPA has asked companies to voluntarily submit information without any safeguards against selective reporting.  EPA has then sought to deny public access even to submitted health and safety studies, arguing they are confidential despite TSCA’s clear prohibition on protecting such information from public disclosure; see here and here.

So EPA proposals that directly affect both what information is submitted to EPA and public access to it warrant serious scrutiny.  I’ll describe both proposals below, but as a preview I first want to highlight some of the key themes detailed in EDF’s comments:

  • EPA continues to resist acknowledging that the 2016 TSCA reforms changed the substantive standard governing confidentiality by imposing new requirements on top of those EPA has relied on in the past in regulations it promulgated pursuant to the Freedom of Information Act (FOIA). In both proposals, EPA must acknowledge the change and incorporate all of the law’s new requirements, which Congress enacted to place new limits on what information is eligible for protection from public disclosure.
  • In one of its proposals, EPA has proposed welcome changes that appear intended to make EPA’s review of confidentiality claims more efficient, by clarifying what companies can and cannot claim as confidential and what substantiation they need to provide to support their claims. However, it falls short of that goal and omits several key provisions that must be incorporated when the proposal is finalized.
  • The other proposal is far less robust and would continue to rely on obsolete regulatory provisions that do not reflect the law’s new requirements. As a result, it is also wholly inconsistent with the first proposal even with respect to the analogous procedures for claim assertion, substantiation and EPA review.
  • In the name of burden reduction, EPA has proposed to continue existing exemptions from chemical information reporting, and to add major new exemptions. If finalized, these exemptions will negatively impact EPA’s access to information on chemicals’ conditions of use, releases and potential exposures that it needs to carry out its duties under reformed TSCA.  The consequences of EPA’s failure to obtain robust information on chemicals it is reviewing were amply demonstrated in critical comments ($) the agency received at last week’s meeting of EPA’s Scientific Advisory Committee on Chemicals (SACC) held to peer review EPA’s first draft risk evaluation under TSCA.

Read More »

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