EDF Health

EPA’s latest analysis shows perchlorate risks to fetal brain development

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

Pursuant to a consent decree with the Natural Resources Defense Council (NRDC), the Environmental Protection Agency (EPA) is developing drinking water regulations to protect fetuses and young children from perchlorate, a toxic chemical that inhibits the thyroid’s ability to make the hormone T4 essential to brain development. The rulemaking is part of a long process that began in 2011 when the agency made a formal determination that Safe Drinking Water Act standards for perchlorate were needed. Under the consent decree, EPA should propose a standard by October 2018.

In the latest step in that process, EPA’s scientists released a draft report in September that, at long last, answers questions posed by its Science Advisory Board in 2013: does perchlorate exposure during the first trimester reduce production of T4 in pregnant women with low iodine consumption? Does reduction in maternal T4 levels in these women adversely affect fetal brain development? According to EPA’s scientists, the answers are Yes and Yes.

For several years, EPA and the Food and Drug Administration (FDA) have developed and refined a model that would predict the effect of different doses of perchlorate on levels of T4 in pregnant women. The latest version of the model addresses women during the first trimester, especially those with low iodine intake. This is important because iodine is essential to make T4 (the number four indicates the number of iodine atoms present in the hormone); perchlorate inhibits its transport from the blood into the thyroid. The risk of perchlorate exposure to fetuses in the first trimester is greatest because brain development starts very early and is fully dependent on maternal T4. If the mother gets insufficient iodine to offset the perchlorate inhibition, she will not produce enough T4 for the fetal brain to develop properly. When free T4 (fT4) levels are low but without increase in thyroid stimulating hormone (TSH), the condition is known as hypothyroxinemia. When T4 production is lowered further, the pituitary gland releases TSH to increase T4 production by a feedback loop mechanism.

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EPA proposes limits on hypochlorite bleach to reduce degradation to perchlorate

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

Every 15 years, the Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) reviews the safety of registered pesticides. The current cycle ends in 2022. As part of that process, the agency is evaluating the safety of hypochlorite bleaches. In January 2017, EPA decided it would consider the risks posed by degradation of the hypochlorite into perchlorate.

This is important for two reasons: 1) degraded bleach is less effective as a pesticide, and 2) perchlorate is a chemical that interferes with the production of thyroid hormone, a critical hormone for fetal and infant brain development.

On September 22, EPA proposed changes to the pesticide label to minimize the degradation for hypochlorite bleach used to disinfect drinking water, and the agency is accepting comments until November 21, 2017. The label would advise users to:

  • Minimize storage time;
  • Maintain pH of the solution between 11 to 13;
  • Minimize exposure to sunlight;
  • Store at lower temperatures; and
  • If practical, dilute with cool softened water upon delivery.

EDF submitted comments to EPA supporting EPA’s proposal and requesting specific changes to the proposed language, including making the advice to users mandatory. We also asked the agency to extend the label requirements to hypochlorite bleach used to treat produce and to disinfect food handling equipment. Bleach appears to be one of several significant sources of perchlorate contamination of food. Improving management conditions will reduce degradation and preserve effectiveness regardless of the whether the bleach is used in drinking water or to treat vegetables.

EPA’s proposal is an interim decision. We also were pleased to see that OPP is committed to continue working with EPA’s Office of Water (OW) in its assessment of the risks of perchlorate to pregnant women and young children. We asked OPP to incorporate the OW’s findings in additional interim registration decisions for all uses of hypochlorite bleaches.

 

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“Tore apart our happy home”: Another chemical embraced by Dourson and Beck is contaminating the drinking water supply in Memphis and across the country

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

[Use this link to see all of our posts on Dourson.]

That lyric from a Chuck Berry signature song, “Memphis, Tennessee,” takes on a haunting new meaning in light of the latest evidence of contamination of the Memphis Sand aquifer, a main drinking water source for the city, with the highly toxic solvent tetrachloroethylene (also known as perchloroethylene (PCE), or more commonly PERC).  Lest there be any doubt about the human toll this is taking, read this local woman’s heart-wrenching story.

The source of PERC in this case is a former dry cleaning business that is now a hazardous waste site, and because of Sharri Schmidt’s case is now nominated to become a Superfund site.  The chemical is still widely used in dry cleaning as well as in many other uses.  It’s a probable human carcinogen, and is also toxic to the brain, kidney and liver.

As I write, Dourson and Beck are making decisions that will help determine how the risks of PERC and other chemicals are assessed and whether or not they need to be regulated.

Unfortunately, Schmidt is far from alone.  PERC contamination of drinking water is widespread in this country.  To name just a few, have a look at these stories from towns and cities in North Carolina, Indiana, Nevada, Arizona, Montana, and New York.

Data compiled by the Environmental Working Group from local water utilities shows that PERC was detected in tap water samples taken by water utilities in 44 states that serve 19 million people.

One might hope and think that affected local communities could turn to the US Environmental Protection Agency for help in such situations.  The sad truth is that under the Trump administration this may well not be the case.  Trump has nominated Michael Dourson to lead EPA’s chemical safety office, who, despite the fact that he’s yet to be confirmed, is already working at EPA as a special advisor to Administrator Scott Pruitt.  And Pruitt has already installed as a political appointee to that office Nancy Beck, who until May was a senior official at the American Chemistry Council (ACC), the chemical industry’s main trade association.

So what do Dourson and Beck have to do with PERC?   Read More »

Also posted in Health Policy, Industry Influence, TSCA Reform / Tagged | Read 1 Response

Little follow-up when FDA finds high levels of perchlorate in food

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

FDA’s apparent lack of follow-up when faced with jaw-dropping levels of a toxic chemical in food is disturbing.

For more than 40 years, the Food and Drug Administration (FDA) has conducted the Total Diet Study (TDS) to monitor levels of approximately 800 pesticides, metals, and other contaminants, as well as nutrients in food. The TDS’s purposes are to “track trends in the average American diet and inform the development of interventions to reduce or minimize risks, when needed.” By combining levels of chemicals in food with food consumption surveys, the TDS data serve a critical role in estimating consumers’ exposure to chemicals.

From 2004 to 2012 (except for 2007), FDA collects and tests about 280 food types for perchlorate, a chemical known to disrupt thyroid hormone production. This information is very important, because for the many pregnant women and children with low iodine intake, even transient exposure to high levels of perchlorate can impair brain development.

The agency published updates on food contamination and consumers’ exposure to perchlorate in 2008 (covering years 2004-2006) and in 2016 (covering 2008-2012). On its Perchlorate Questions and Answers webpage, FDA says it found “no overall change in perchlorate levels across foods” in samples collected between 2008 and 2012 compared to those collected between 2005 and 2006. It also notes that there were higher average levels in some food and lower in others between the time periods and suggests that a larger sampling size or variances in the region or season when the samples were collected may account for the differences.

FDA’s Q&A webpage masks the most disturbing part of the story

FDA’s attempt at providing consumers with information about the presence of a toxic chemical in food and what it means for their health falls short. By focusing on the similar average level of perchlorate across foods, FDA masks the disturbing fact that children are consuming increasing amounts of perchlorate: 35% for infants, 23% for toddlers and 12% for children between 2 and 6 from 2004-2006 to 2008-2012. The agency’s webpage notes the exposures in 2008-2012 but fails to mention the increase reported by its own scientists.

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To be true to your new directive, Mr. Pruitt, you need to fire Michael Dourson today

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

[Use this link to see all of our posts on Dourson.]

EPA Administrator Scott Pruitt issued a directive today that prevents independent scientists who receive research grants from EPA from serving on any EPA advisory panels.  Wholly unaddressed by the directive is any counterpart prohibition on scientists funded by industries with conflicts of interest from serving as EPA advisors.  

If Pruitt firmly believes that receipt of EPA funding is a basis for disqualifying a scientist from advising the agency, then he need look no further for someone to purge than his own recently named “advisor to the Administrator” on chemicals, Michael Dourson.

When it comes to advice the agency receives, the core concern over the need to avoid conflicts of interest is this:  Is advice tainted because the entity employing and paying the advisor stands to gain or lose financially from the agency decision that is under advisement?  Say, for example, EPA selected as an advisor a consultant to Koch Industries who it paid for work that concluded the company’s releases into the environment of the petcoke generated by its facilities are safe.  A reasonable person would have a basis to believe that Koch could benefit financially from the advice its consultant might provide the agency.  In contrast, how does EPA stand to benefit financially from the results of research conducted by an EPA-funded scientist?  The simple answer is, it doesn’t.

Now let’s look at it from the perspective of the scientist receiving the funding.  Pruitt’s directive is based on the outlandish premise that EPA funds research in order to find problems it can then regulate, and hence that an EPA-funded researcher has an incentive to find a problem in order to better ensure continued EPA funding.  The claim is that the advice offered by that researcher would be “pre-tainted” toward supporting EPA policy decisions that drive regulation.  This theory that imagines a grand conspiracy between researchers and the agency is inherently flawed and unfounded.   Read More »

Also posted in EPA, Health Policy, Industry Influence, TSCA Reform / Tagged | Comments are closed

In 2016 industry-funded paper, Dourson and Beck sought weaker standard for lethal paint stripper chemical

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

[Use this link to see all of our posts on Dourson.]

[See clarification added on 10-26-17 in brackets below.]

The New York Times’ investigation “Why Has the E.P.A. Shifted on Toxic Chemicals? An Industry Insider Helps Call the Shots” published this past Sunday cited evidence that Nancy Beck – a political appointee in EPA’s chemical safety office who until May was a senior official at the American Chemistry Council (ACC) – is questioning the need for EPA’s proposed rule to ban the use of the deadly chemical dichloromethane (also called methylene chloride) in paint and coating removers.  These products are responsible for dozens of deaths in recent years.

The Times’ story also noted in its last paragraph that Beck and Michael Dourson – the Trump Administration’s controversial nominee to lead EPA’s chemical safety office – are co-authors on a 2016 paper that was funded by ACC.  That paper was published in the industry’s go-to journal, Regulatory Toxicology and Pharmacology, where Dourson has published most of his papers.

The paper is of interest and relevant for another reason as well:  Dourson and Beck assert that the acceptable risk levels EPA has set for 24 chemicals are all too stringent and should be relaxed by anywhere from 2.5 to 150 fold.  (Funny, isn’t it, how the numbers for all 24 chemicals all went in the same direction?)

Among these 24 chemicals is the paint-stripping chemical dichloromethane (aka methylene chloride).  This chemical is a particularly concerning one:  It is a likely carcinogen and is linked to numerous other chronic health impacts, but it is also acutely and tragically lethal.   Dourson and Beck call for EPA’s standard for the chemical to be relaxed to a level that is 8.3 times less protective. [Clarification added 10-26-17:  This factor applies to EPA's ingestion standard (reference dose); Dourson and Beck's proposed adjustment to EPA's inhalation standard (reference concentration) was 2.5-fold less protective.]

The Times article makes clear that, despite her prior work on this chemical while at ACC, and the fact that this chemical is made by numerous ACC companies, Beck has not recused herself from making decisions about its risk and regulatory responses – decisions that are being considered at EPA even as I write.  Indeed, as I noted earlier this week, her astounding ethics agreement gives her wide latitude to work on issues in which ACC has financial interests in order to ensure those interests are taken into account.

In Dourson’s nomination hearing held by the Senate Environment and Public Works Committee on October 4, he was repeatedly asked if he would, if confirmed, recuse himself from work on chemicals he had been paid by industry to work on, and he repeatedly refused to say he would do so.

One more reason that Michael Dourson should not be entrusted with our health and the Senate should reject his nomination to head EPA’s toxics office.

Just yesterday, Dourson’s nomination was voted out of the committee by an 11-10 vote.  The fight over his nomination now moves to the full Senate.

 

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