EDF Health

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

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.

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Also posted in Drinking Water, EPA, Health Science, perchlorate / Tagged , , , | Read 1 Response

Company safety data sheets on new chemicals frequently lack the worker protections EPA claims they include

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

Readers of this blog know how concerned EDF is over the Trump EPA’s approval of many dozens of new chemicals based on its mere “expectation” that workers across supply chains will always employ personal protective equipment (PPE) just because it is recommended in the manufacturer’s non-binding safety data sheet (SDS).

How much farther under the bus will the Trump EPA throw American workers?

The typical course has been for EPA to identify risks to workers from a new chemical it is reviewing under the Toxic Substances Control Act (TSCA), but then – instead of issuing an order imposing binding conditions on the chemical’s entry onto the market, as TSCA requires – to find that the chemical is “not likely to present an unreasonable risk” and impose no conditions whatsoever on its manufacturer.  This sleight of hand is pulled off by EPA stating that it:

expects employers will require and workers will use appropriate personal protective equipment (PPE) … consistent with the Safety Data Sheet prepared by the new chemical submitter, in a manner adequate to protect them.

We have detailed earlier the myriad ways in which this approach strays from the law, is bad policy and won’t protect workers.  But here’s yet another gaping problem:  When we are able to look at the actual SDSs – that is, when EPA has made them available and when they are not totally redacted – we are frequently finding that the specific PPE that EPA claims to be specified in the SDSs – and that EPA asserts is sufficient to protect all workers handling the chemical – is not in the SDSs.   Read More »

Also posted in EPA, Industry Influence, Regulation, TSCA Reform, Worker Safety / Tagged | Read 1 Response

Round 2 on PV29 reveals even deeper flaws in EPA’s TSCA risk evaluation of the chemical

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

On Friday, Environmental Defense Fund (EDF) submitted a new set of extensive comments to the Environmental Protection Agency (EPA) in response to its March release of additional information on Pigment Violet 29 (PV29), the first chemical to undergo a risk evaluation under the Toxic Substances Control Act (TSCA) following the law’s amendment in 2016.

After EDF and others criticized both the dearth of health and environmental data on PV29, and EPA’s illegal withholding of those data, EPA released some additional information and opened a new comment period in mid-April.  In releasing the new information, EPA was quick to judgment, asserting that “[t]he release of these studies does not change the Agency’s proposed ‘no unreasonable risk’ determination as concluded in the draft risk evaluation published in November.”

EDF’s 100 pages of comments in Round 1 enumerated the myriad ways EPA has failed to demonstrate that PV29 does not present unreasonable risk.  Unfortunately, if anything, Round 2 has only deepened our concerns over the inadequacy of EPA’s risk evaluation.   Read More »

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EPA says PV29 is perfectly safe. The EU, citing concerns and a dearth of data, begs to differ.

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

In contrast to the Environmental Protection Agency’s (EPA) asserted clean bill of health for Pigment Violet 29 (PV29) in its draft risk evaluation, authorities under the European Union’s REACH program have formally declared the chemical to be a suspected persistent, bioaccumulative and toxic (PBT) substance and a suspected very persistent and very bioaccumulative (vPvB) substance.  Either designation, if confirmed, would classify PV29 as a substance of very high concern (SVHC) under the EU’s REACH Regulation.

In EDF’s earlier comments on EPA’s draft risk evaluation, we noted that PV29 had been proposed to be so listed under REACH and to undergo a full substance evaluation in 2021.  Since we filed those comments, the European Chemicals Agency (ECHA) has published an update to its Community Rolling Action Plan (CoRAP) that now formally designates PV29 as a “suspected PBT/vPvB” that will be subject to a full substance evaluation.  The listing is accompanied by a “justification document” for PV29’s designation.

The justification document, prepared by the Belgian Competent Authority (BE CA) under REACH and endorsed by REACH authorities, echoes many of the concerns about PV29 and EPA’s draft risk evaluation that EDF had raised in our earlier comments.   Read More »

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

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, EPA, Health Science, Industry Influence, perchlorate / Tagged , , , | Read 2 Responses

EDF tells EPA it must modify its proposed CBI Claim Review Rule to comply with recent D.C. Circuit decision

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

Yesterday Environmental Defense Fund (EDF) sent a letter to the Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention in follow-up to last month’s decision by the D.C. Circuit Court of Appeals in EDF’s challenge to EPA’s Inventory Notification Rule (EDF v. EPA, 17-1201).

The letter identifies “immediate, time-sensitive implications [of the decision] for EPA’s ongoing rulemaking for” EPA’s proposed Confidential Business Information (CBI) Claim Review Rule, which is currently undergoing public comment.  EDF noted that, in addition to addressing problems the Court identified in EPA’s regulations promulgated pursuant to its Inventory Notification Rule, EPA will need to modify the current proposed rule to ensure it is consistent with the Court’s Opinion, and accept comments on the modified proposal.

This is because the proposed rule explicitly references and applies regulatory provisions that the Court found were unlawful.  Specifically, the Court found that EPA’s CBI claim substantiation questions were flawed because they failed to inquire into “a chemical identity’s susceptibility to reverse engineering” and “effectively excised a statutorily required criterion from the substantiation process.”  Hence, to align the proposed rule with the Court’s ruling and the representations that EPA made to the Court in its briefing and at argument, EPA will need to revise the substantiation questions and the substantive standard that EPA plans to use when reviewing claims under the CBI Claim Review Rule.

EDFs letter also notes that the proposed rule allows persons to rely on the voluntary substantiations they submitted as part of the Inventory notification process.  But the Court’s Opinion establishes that these substantiations are inadequate because they fail to address a chemical’s susceptibility to reverse engineering, and EPA will need to modify the proposed rule to require companies to provide substantiations that address this statutory factor for confidentiality claims.

See EDF’s letter for more details.

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