EDF Health

EPA’s just-released methylene chloride draft risk evaluation: Some important context

By / Published: October 29, 2019

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

After more than a month’s delay, EPA today released its draft risk evaluation for methylene chloride.  Running to 725 pages (not counting more than a dozen supplemental files), it will take some time to digest.  But here are some initial observations that provide context for those of you who will be looking closer.

First, methylene chloride is a very nasty chemical.  It has killed a lot of people.  It causes cancer.  Short- and long-term exposure to it is tied to liver effects, immune system effects, nervous system effects, and reproductive/developmental effects.

So it shouldn’t be surprising that EPA’s draft – even coming from an administration not known to be overly worried about the risks of chemicals – has found that most industrial, commercial and consumer uses of methylene chloride present unreasonable risks.

For example, EPA found that workers using methylene chloride-based paint strippers face high risks.  Of course, we knew that already:  EPA identified those risks more than five years ago, and proposed to ban those uses.  This EPA decided it had to do it all over again – which means that thousands of workers have continued to be unnecessarily exposed to this deadly chemical.  And it will be even more years before we get back to where we were before EPA took its mulligan.

So the good news is that EPA seems to be acknowledging that methylene chloride presents high enough risks to warrant regulation under the Toxic Substances Control Act (TSCA).

The bad news is that EPA is dramatically underestimating the magnitude of methylene chloride’s risks – by pulling the same tricks it has for other chemicals among the first 10 it is evaluating under TSCA:

  • EPA once again ignores all exposures and risks to the general population by falsely assuming those exposures and risks are eliminated by actions it has taken or could take under other laws. That means ignoring over 4 million pounds of methylene chloride annually released to air, water and land.  See this backgrounder for the details and why this EPA assumption about methylene chloride is deeply flawed.
  • EPA once again grossly understates risks to workers:
    • EPA assumes that workers will always wear fully effective personal protective equipment (respirators and gloves) to make many of the risks it identifies go away – and to grossly understate the magnitude of the unreasonable risks it does find.
    • EPA once again finds a cancer risk to workers unreasonable only if it exceeds a level of 1 in 10,000 – which is 100 times higher a risk than warrants regulation under TSCA to protect workers and other vulnerable subpopulations.
    • For occupational non-users (ONUs), EPA has once again failed to identify unreasonable risks for the most highly exposed, and hence most vulnerable, workers unless it finds that the majority of workers also face unreasonable risks.

These are just a few initial observations based on our reading of EPA’s opus so far.

So while it’s somewhat encouraging that this new draft risk evaluation has found many more risks than previous drafts, we can already tell the draft falls far short of adequately describing the risks presented by methylene chloride.

Stay tuned.

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EDF joins court challenge of FDA’s refusal to ban use of perchlorate in food contact materials

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: October 29, 2019

Tom Neltner, J.D., is Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

Today, EDF, represented by Earthjustice, joined with other public health advocates in filing a lawsuit to overturn the Food and Drug Administration’s (FDA) May 2017 decision, reaffirmed in April 2019 that allows the continued use of perchlorate[1], at concentrations up to 12,000 parts per million, in plastic packaging and processing equipment in contact with dry food. Perchlorate exposure is particularly dangerous for fetuses, infants, and young children, as it has been linked to developmental delays, reduced growth, and impaired learning capabilities. FDA relied on flawed reasoning while entirely ignoring important evidence developed by its own scientists revealing potentially serious risks resulting from ongoing use of perchlorate. We maintain that the intentional and unnecessary use of perchlorate in food contact materials should end.[2]

As with any litigation, we take this action reluctantly. We have long questioned FDA’s decisions that ignore evidence that endocrine disruptors like perchlorate can cause harm at levels the agency systematically dismisses as trivial. We have also pushed back on FDA’s decisions that allow toxic chemicals to be used in packaging and processing equipment that contact food ingredients multiple times from the farm to the grocery store shelf when the exposure estimate is based solely on the amount of the chemical that may migrate into food from the final product packaging. Agency assertions that its estimates are based on worst-case assumptions are misleading when they only consider a single contact. While FDA’s initial decision in November 2005 allowing the use of perchlorate-containing plastic raises all of these problems, the agency’s failure to address its own data and accompanying analysis by its own scientists that was published a decade later has left us with little choice but to act.

Read More »

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

By / Published: October 13, 2019

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

By / Published: October 2, 2019

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.[pullquote]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.[/pullquote]

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 »

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Peer reviewers confirm EPA has failed to show Pigment Violet 29 doesn’t present unreasonable risk

By / Published: September 23, 2019

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

Late on Friday, EPA quietly posted the final peer review report of the Scientific Advisory Committee on Chemicals (SACC) for pigment violet 29, the first chemical for which EPA issued a draft risk evaluation under the Toxic Substances Control Act (TSCA) as amended in 2016.

No wonder EPA posted it late Friday with no announcement.  The peer reviewers’ report confirms what EDF and others have been saying since release of the draft:  EPA has fallen far short of supporting its sweeping conclusion that the chemical does not present unreasonable risk, including to vulnerable subpopulations.  The report also faults EPA’s use of systematic review, and reiterates that EPA needs to submit its method to the National Academy of Sciences for review.  Read More »

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No, Bergeson & Campbell, the public’s right to know about new chemicals is not a distraction or waste of resources

By / Published: September 20, 2019

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

Earlier this month, EDF and other NGOs filed a notice of intent (NOI) to sue the Environmental Protection Agency for violations of the Toxic Substances Control Act and its own regulations that deny the public timely access to information on chemicals companies seek to bring onto the market.

Members of the public have a right to know about chemicals entering the market because they may well be exposed to them.  And they have a right to know about and meaningfully participate in EPA’s review of the safety of those chemicals because such transparency, accountability, and public participation are fundamental to good government, as well as being required by the law.

This week the industry law firm Bergeson & Campbell (B&C) offered a commentary on the NOI, lamenting it as “hugely distracting and draw[ing] resources and [EPA] management’s attention away from other priorities.”  Note that B&C represents many companies that submit new chemicals to EPA for review under TSCA and has been a central actor in the chemical industry’s efforts to weaken those reviews.

In its commentary, B&C acknowledges that the NOI has identified real legal violations committed by EPA, and that these violations result in the public having less information about the agency’s new chemicals program.  But B&C asserts that the violations don’t really matter because they have been going on for a long time, not just under this administration.  While that is true in some cases, the argument ignores the two elephants in the room.  Read More »

Also posted in Health policy, Industry influence, TSCA reform / Tagged , | Comments are closed