EDF Health

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

By Richard Denison / Published: September 3, 2019

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

By Richard Denison / Published: July 22, 2019

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

By Richard Denison / Published: June 25, 2019

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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The Trump EPA’s latest TSCA gift to the chemical industry is illegal and the height of hypocrisy

By Richard Denison / Published: December 4, 2018

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

‘Tis the season for giving, but it’s not quite keeping in the spirit to have our Environmental Protection Agency (EPA) pile on giveaways to the chemical industry.  The latest one I’ll discuss in this post is not only in direct violation of the Toxic Substances Control Act (TSCA); it exposes this EPA’s two-facedness when it comes to making public the information EPA relies on in making regulatory decisions that affect our health and our environment.[pullquote]EPA’s failure to make health and safety studies available to the public is blatantly illegal and a slap in the face to the 2016 bipartisan reforms to TSCA that sought to increase public access to information on chemical risks.[/pullquote]

First some background.  It has been a long time since EPA has proposed a rule to require testing to determine the hazards of a chemical; the last time was way back in 2011.  (That proposed rule was never finalized.  And despite Congress’ major expansion of EPA’s authority to require testing when reforming TSCA in 2016, EPA has steadfastly refused to even consider use of that new authority.)

The American Chemistry Council (ACC) filed comments opposing the 2011 proposed rule.  As I blogged about at the time, ACC insisted that, instead of calling on its members to provide the health and safety data sought through the proposed rule, EPA should seek to get it from the European Chemicals Agency (ECHA). ACC asserted that ECHA likely had already received the requested data under the European Union’s (EU) REACH Regulation.  I noted that’s not as easy as it sounds, because the chemical industry itself has thrown up major roadblocks to such inter-governmental data sharing.  But here’s the rub:  ACC further argued that, should EPA succeed in obtaining the health and safety data submitted to ECHA, EPA could and should deny public access to those data – despite the fact that TSCA clearly prohibits EPA from withholding health and safety studies.  ACC added that the public should make do with mere summaries of the studies, summaries that were prepared by the companies making the subject chemicals.

At the time, EPA was having none of this.  It indicated that if necessary it could use, and was considering using, its subpoena authority under section 11(c) of TSCA to get the studies from the companies that had submitted them to ECHA; see pages 16-17 of this 2013 report from the Government Accountability Office (GAO).

That was then.  Now, with a former ACC senior official essentially running the TSCA office at EPA, the agency is virtually following ACC’s script.   Read More »

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