EDF Health

The Trump EPA is illegally denying requests for public files on new chemicals

By / Published: June 3, 2019

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

For some time now, Environmental Defense Fund (EDF) has been requesting “public files” of new chemical notices the Environmental Protection Agency (EPA) receives under the Toxic Substances Control Act (TSCA).  The process is kludge-y to say the least.  We have to email our request to EPA’s Docket Center, and, typically, several weeks later the staff there copy the files that staff in the TSCA office have given them in response to our request onto a CD-ROM and snail-mail it to us.

This, despite the fact that EPA’s own regulations (see here and here) state unequivocally that EPA is to promptly make new chemicals’ premanufacture notifications (PMNs) and associated documents broadly available to the general public by posting them to electronic dockets.  One regulation states: “All information submitted with a notice, including any health and safety study and other supporting documentation, will become part of the public file for that notice, unless such materials are claimed confidential.”  The other regulation states that public files are to be made available in the electronic docket posted at http://www.regulations.gov.

We have blogged extensively about how, even once we receive the public files, they are rife with wholesale omissions, illegal redactions and myriad other problems.

After two years of our repeated requests to EPA to comply with its own regulations, it appears EPA may be taking a first step to try do so:  EPA recently announced (via email, but not anywhere on its website that we can find) that it will start posting PMNs and associated documents it receives in the future to its ChemView database, within 45 days of their receipt.  While this could be a welcome development, it does nothing to remedy EPA’s failure to provide access to the thousands of PMNs it has received in the past.  And it remains to be seen what EPA actually will and won’t be posting.

We’ll be watching closely to see when and what EPA actually makes available.  Part of the need for vigilance comes from a disturbing response we’ve been receiving from EPA’s Docket Center to some recent requests for new chemical public files:   Read More »

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

EPA distorts the scientific evidence and fails to protect kids’ brains in its proposed limit for perchlorate in drinking water

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: May 24, 2019

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

Today, the Environmental Protection Agency (EPA) proposed a Maximum Contaminant Level (MCL) of 56 parts per billion (ppb) for perchlorate in drinking water – more than three times less protective than an interim health advisory level set in 2008. To justify this increase, EPA turned its back on scientific evidence showing that this potent neurotoxin undermines childrens’ motor development and control and can increase their anxiety and depression. The agency’s reasoning is inconsistent with its own analysis published in a draft report in late 2017 and the findings of a peer review panel it convened last year to review that report.

If the agency had used the most protective scientific study and the most sensitive endpoint evaluated in the proposed rule, the MCL would likely be 4 ppb – more than three times more protective than the current health advisory. As a result, the agency fails to adequately protect children from a lifetime of harm. With this MCL, EPA is allowing pregnant women to be exposed to perchlorate in the first trimester of pregnancy at levels that pose much greater risk of impaired neurodevelopment in their children.

The proposed MCL – and how the agency reached it – was both a disappointment and a surprise to us. In late 2017, we applauded the agency’s scientists for developing an innovative model connecting a mother’s perchlorate exposure in the first trimester to fetal harm. We were not alone – in early 2018, EPA’s peer review panel congratulated the agency’s scientists on their analysis. We also complimented EPA’s population-based approach to developing an MCL by estimating the percent of pregnant women, and their children, with borderline thyroid dysfunction due to low iodine intake.

So how did EPA abruptly change course and estimate an MCL less protective than the current health advisory? By altering its analysis in three subtle but significant ways:

  1. Rejecting five epidemiology studies showing harm at even lower exposure levels in favor of one IQ study by Korevaar et al. in 2016.
  2. Choosing an MCL that allows an IQ loss of 2 points even though the study showed a 1 point loss was statistically significant.
  3. Dismissing an alternative, population-based method that EPA proposed in 2017 that reinforces the need for a more protective standard.

Read More »

Also posted in Drinking water, Health policy, Health science, Perchlorate / Tagged , , , | Read 1 Response

EPA’s safety standard for perchlorate in water should prioritize kids’ health

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: May 7, 2019

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

The Environmental Protection Agency (EPA) will soon propose a drinking water standard for perchlorate. The decision – due by the end of May per a consent decree with the Natural Resources Defense Council (NRDC)— will end a nearly decade-long process to regulate the chemical that has been shown to harm children’s brain development.

In making its decision, EPA must propose a Maximum Contaminant Level Goal (MCLG) “at the level at which no known or anticipated adverse effects on the health of persons occur and which allows an adequate margin of safety.”[1] It must also set a Maximum Contaminant Level (MCL) as close to the MCLG as feasible using the best available treatment technology and taking cost into consideration.

To guide that decision, EPA’s scientists developed a sophisticated model that considers the impact of perchlorate on the development of the fetal brain in the first trimester when the fetus is particularly vulnerable to the chemical’s disruption of the proper function of the maternal thyroid gland. As discussed more below, the model was embraced by an expert panel of independent scientists through a transparent, public process that included public comments and public meetings.

In April, a consulting firm published a study critiquing EPA’s model. The authors acknowledged the model as a valuable research tool but did not think it is sufficient to use in regulatory decision-making due to uncertainties. Therefore, the authors concluded that EPA should discard the peer-reviewed model and rely on a 14-year old calculation of a “safe dose” that does not consider the latest scientific evidence and has even greater uncertainties. They didn’t offer other options such as using uncertainty factors to address their concerns about the model’s estimated values.

Given the importance of the issue and the risk to children’s brain development, we want to explain EPA’s model, the process the agency used to develop it, and the study raising doubt about the model.

Read More »

Also posted in Drinking water, Health policy, Health science, Industry influence, Perchlorate / Tagged , , , | Read 2 Responses

Latest available national data shows increase in blood lead levels for at least 2 million kids

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 15, 2019

Tom Neltner, J.D., Chemicals Policy Director

In February, the Centers for Disease Control and Prevention (CDC) released a report summarizing the biomonitoring data from its National Health and Nutrition Examination Survey (NHANES). Given EDF’s focus on protecting children from lead exposure, we went straight to the most recent blood lead monitoring results. The results are disturbing. As shown in Figure 1 below, after years of progress, in 2015-16 the blood lead levels (BLLs) of more than 2 million young children[1] increased:

  • Average child BLL: 48% BLL decrease from 2007-8 to 2013-14 but only a 3% decrease in 2015-16.
  • 75th percentile BLL (75% of children are below this level): 51% decrease from 2007-8 to 2013-14 but a 2% increase in 2015-16.
  • 90th percentile BLL: 51% decrease from 2007-8 to 2013-14 but an 18% increase in 2015-16.
  • 95th percentile BLL: 45% decrease from 2007-8 to 2013-14 but a 23% increase in 2015-16.

As with the smaller uptick in 2007-08 (which may have been related to the housing crises), it may only be short-term setback, nonetheless it bears careful examination.

Even more disturbing is the Trump Administration’s response to this information. The Administration:

  • Ignored the data in the rosy picture of progress it painted in its recent Lead Action Plan; and
  • Appears to be repeating mistakes of the past by proposing to slash CDC’s childhood lead poisoning prevention budget in half.

Read More »

Also posted in Health policy, Lead / Tagged , , | Authors: / Comments are closed

PART 3: Busting more industry-perpetrated myths about new chemicals and worker protection under TSCA

By / Published: April 3, 2019

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

Part 1          Part 2         Part 3

I have been blogging in the last few weeks about myths the chemical industry is perpetrating about the adequacy and legality of the Environmental Protection Agency’s (EPA) recent reviews of the risks that chemicals just entering the market may present to workers.  In this post, I address another such myth that, unfortunately, EPA has swallowed hook, line, and sinker.  This myth was laid out by one of the industry witnesses at the March 13 House Energy & Commerce Committee hearing on EPA’s failures to protect workers from chemical risks.[pullquote]One wonders when EPA will start doing what Congress told it to do, first in 1976 and then again, with renewed vigor in 2016:  Protect workers under TSCA – using TSCA’s authorities to meet TSCA’s health standard, not OSHA’s.[/pullquote]

I’ll get to this third myth in a moment.  But let me first try to crystallize what is at stake in this debate.  While the Toxic Substances Control Act (TSCA) has always given EPA authority to regulate workplace risks, the 2016 amendments to TSCA strengthened EPA’s authority and mandate to protect workers.  TSCA now expressly identifies workers as a “potentially exposed or susceptible subpopulation.”  See the definition of that term in paragraph 12 here.  TSCA then requires EPA to identify and assess potential risks to such subpopulations when reviewing both new and existing chemicals.  Finally, it requires EPA to use its TSCA authorities to impose restrictions on any chemical found to present an “unreasonable risk” – which is TSCA’s health standard – to any such subpopulation.

In a word, TSCA requires EPA to protect workers under TSCA – using TSCA’s authorities to meet TSCA’s health standard, not OSHA’s.

Both before and after the 2016 TSCA amendments, the chemical industry has sought to compel or convince EPA not to regulate workplaces under TSCA, and instead to defer to OSHA.  Industry wants this because OSHA’s authority and capacity are severely limited and its legal requirements for regulating toxic substances (“health standards” in OSHA parlance) allow vastly greater risks to workers than do TSCA’s (see my previous post).

Sadly, under the Trump EPA, industry is getting its wish.  At industry’s urging, EPA is acting in a manner that is wholly contrary to TSCA – and is less health-protective than even under TSCA before the 2016 reforms.

Now let’s get back to more myth-busting.   Read More »

Also posted in Health policy, Industry influence, Regulation, TSCA reform, Worker safety / Tagged , , , , | Authors: / Comments are closed

EDF to OMB: Ban on methylene chloride in paint strippers must protect workers in addition to consumers

By Lindsay McCormick / Published: February 7, 2019

Lindsay McCormick, Project Manager, and Joanna Slaney, Legislative Director

[pullquote]

Over 11,000 concerned Americans have sent messages to Members of Congress over the last two weeks to urge EPA and OMB to protect workers – the population at most risk – from methylene chloride in paint strippers.

[/pullquote]Today, EDF met with the White House Office of Management and Budget (OMB) about the Environmental Protection Agency’s (EPA) draft final rule on methylene chloride-based paint strippers. We urged the office to ensure the ban on methylene chloride-based paint and coating removers covers both consumer and most commercial uses – as the agency originally proposed.

Removing these deadly products from stores, workplaces, and homes is a critical step to protecting public health. Methylene chloride is acutely lethal. Exposure to the chemical has led to over 50 reported worker deaths since the mid-1980s, more than 40 of which are attributed to use of methylene chloride-based paint strippers. Many more deaths have likely gone unreported. The chemical is also associated with a host of other serious health effects, including neurotoxicity, cancer, and liver impairment.

Despite the facts that workers represent the vast majority of reported deaths and face the highest risks of other health effects, it appears that EPA is poised to finalize a rule that excludes a ban on commercial uses entirely – and will instead merely initiate a lengthy, uncertain process that may lead to certification and training approaches EPA had already considered and rejected as inadequate to protect workers.

Read More »

Also posted in Health policy, Public health, Regulation, TSCA reform / Tagged , , , , | Authors: / Comments are closed