EDF Health

EPA proposes second rule to ban more uses of toxic TCE

By Jennifer McPartland / Published: January 12, 2017

Jennifer McPartland, Ph.D., is a Senior Scientist with the Health Program.

The Environmental Protection Agency (EPA) took another significant step yesterday to protect against exposures to the highly toxic chemical, trichloroethylene (TCE), proposing a rule to ban its use as a vapor degreaser.

The proposed rule is the second issued under section 6 of the Toxic Substances Control Act (TSCA) as amended by last year’s Lautenberg Act.  It follows on EPA’s proposed rule last month to ban the use of TCE as an aerosol degreaser and spot cleaning agent in dry cleaning facilities. Both proposed rules on TCE are critical to protecting consumer and worker health from the harmful effects of TCE and should move swiftly toward finalization.   Read More »

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At last: EPA promulgates nanomaterial reporting rule

By / Published: January 11, 2017

Richard Denison, Ph.D., is a Lead Senior Scientist. Lindsay McCormick is a Project Manager.  

nanomaterial-infographic

Today, EPA issued its long-awaited rule to gather risk-relevant information on nanoscale materials. The new rule will finally allow EPA to obtain basic data on use, exposure, and hazards from those that manufacture or process these materials, which has long been recognized by experts as essential to understand and manage their potential risks.

Nanomaterials – a diverse category of materials defined mainly by their small size – often exhibit unique properties that can allow for novel applications but also have the potential to negatively impact our health and the environment.  Some nanomaterials:  more easily penetrate biological barriers than do their bulk counterparts; exhibit toxic effects on the nervous, cardiovascular, pulmonary, and reproductive systems; or have antibacterial properties that may negatively impact ecosystems or lead to resistance.

Read More »

Also posted in Emerging science, Nanotechnology, Regulation / Tagged | Comments are closed

FDA finds more perchlorate in more food, especially bologna, salami and rice cereal

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 9, 2017

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

Last month, the Food and Drug Administration’s (FDA) scientists published a study showing significant increases in perchlorate contamination in food sampled from 2008 and 2012 compared to levels sampled from 2003 to 2006. The amount of perchlorate infants and toddlers eat went up 34% and 23% respectively. Virtually all types of food had measurable levels of perchlorate, up from 74%. These increases are important because perchlorate threatens fetal and child brain development. As we noted last month, one in five pregnant women are already at great risk from any perchlorate exposure. The FDA study doesn’t explain the increase in perchlorate contamination. Yet, it’s important to note that there is one known factor that did change in this time period: FDA allowed perchlorate to be added to plastic packaging.

Reported perchlorate levels in food varied widely, suggesting that how the food was processed may have made a significant difference. The increase in three foods jumped out to me:

  • Bologna: At a shocking 1,557 micrograms of perchlorate per kilogram (µg/kg), this lunchmeat had by far the highest levels. Another sample had the fifth highest levels at 395 µg/kg. Yet a quarter of the other bologna samples had no measurable perchlorate. Previously, FDA reported levels below 10 µg/kg.
  • Salami: One sample had 686 µg/kg giving it a third ranking. Other samples showed much lower levels and six of the 20 had no detectable levels of perchlorate. Previously, FDA reported levels below 7 µg/kg.
  • Rice Cereal for Babies: Among baby foods, prepared dry rice cereal had the two highest levels with 173 and 98 µg/kg. Yet, 15 of the 20 samples had non-detectable levels of perchlorate. Previously, FDA reported levels less than 1 µg/kg.

The increases are disturbing in light of the threat posed by perchlorate to children’s brain development and the emerging science showing the risk at lower levels is greater than thought a decade ago. The risk is particularly significant for children in those families loyal to those brands with high levels. Unfortunately, FDA’s study does not identify the brand of food tested. Read More »

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Perchlorate regulation: Critical opportunities for EPA and FDA to protect children’s brains

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: December 15, 2016

Tom Neltner, J.D., is Chemicals Policy Director

All Americans who have been tested have perchlorate in their bodies. Perchlorate threatens fetal and child brain development by impairing the thyroid’s ability to transport iodine in the diet into the gland to make a thyroid hormone, known as T4, that is essential to brain development. Both the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) are scheduled to make decisions in 2017 that could significantly reduce exposure to this hazardous chemical.

Based on statements in a new report by EPA, we estimate that at least 20% of pregnant women are already iodine deficient, resulting in T4 levels that put the fetuses’ developing brains at risk. For this population of pregnant women, any perchlorate exposure results in an even greater risk of impaired brain development in their children and potentially a lifetime of behavioral and learning difficulties.

This is why it is critical that our public health agencies take actions to reduce exposure to perchlorate with a focus on this vulnerable population. There are three key decisions to be made in the coming year:

  1. EPA will decide in January 2017 whether hypochlorite bleach, an antimicrobial pesticide, degrades to perchlorate in significant amounts. If EPA agrees it does, the agency must set standards to limit that degradation as part of its 15-year update to the pesticide’s registration. Bleach is a widely-used disinfectant in food manufacturing facilities and likely a significant source of perchlorate in contaminated foods. Research shows that reducing hypochlorite concentration limits degradation and this, coupled with expiration dates on the product would significantly reduce exposure to perchlorate.
  2. FDA will decide whether perchlorate should continue allowing perchlorate to be added to plastic packaging for dry food at levels up to 12,000 ppm to reduce buildup of static charges. The agency has evidence that the perchlorate migrates from the packaging into food, especially when it flows in and out of the container. In response to a lawsuit filed by public interest organizations, FDA told a court that it aims to make a final decision by the end of March 2017. A 2008 report by FDA indicated that almost 75% of all food types are contaminated with perchlorate.
  3. EPA told a court that it will complete external peer review of a dose-response model in October 2017 and sign a proposed rule to regulate perchlorate in drinking water a year later. This model is a critical step in establishing a drinking water standard for perchlorate pursuant to its 2011 determination that an enforceable standard was necessary under the Safe Drinking Water Act. The perchlorate is most likely from contaminated source waters (e.g. from military and defense industry activities and some fertilizer use in agricultural regions) or from degradation of hypochlorite bleach used to disinfect water. EPA acted in response to a lawsuit by the Natural Resources Defense Council.

To guide their decision-making, FDA and EPA collaborated to develop a biologically-based dose-response model to predict T4 levels in pregnant women, fetuses, and infants exposed to perchlorate. EDF and NRDC submitted joint comments on the model and the summary report requesting that EPA ensure protection of fetuses during the first two trimesters for pregnant women with serious iodine deficiencies.  These fetuses are particularly vulnerable because their thyroids is not yet functioning. The current fetal model only considers the third trimester when the fetus has a functioning thyroid. The current model fails to adequately protect their vulnerable subpopulations, falling shot of both the EPA’s Science Advisory Board recommendation and the Safe Drinking Water Act requirements.

For decades, federal agencies have been charged with protecting children from environmental health risks with the recognition that they are uniquely vulnerable to chemical exposures. The upcoming decisions on perchlorate present critical opportunities to protect what many of us value the most—our children’s health and their ability to learn and thrive to their fullest potential.

Also posted in Drinking water, Emerging science, FDA, Food, General interest, Health policy, Perchlorate, Regulation / Tagged , , , , , , , , | Comments are closed

EDF files comments on three TSCA rules EPA is developing

By / Published: August 25, 2016

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

Yesterday was the deadline for stakeholders to file written comments on three rules EPA is now developing, as required under the new Toxic Substances Control Act (TSCA as amended by the Lautenberg Act).  EPA is moving quickly to get input on these rules, which it intends to propose in December in order to stay on track to finalize the rules by June of next year, as mandated under the new law.

The solicitation of written comments follows public meetings EPA held on August 9, 10 and 11 to get input from stakeholders on these rules, at which dozens of stakeholders provided oral comments.  Those meetings were the first EPA public meetings since the Lautenberg Act was signed into law on June 22.

The three rules (and associated docket numbers) on which EPA solicited comments are:

  • Risk-Based Prioritization Procedural Rule, which will set forth the process and criteria EPA will use to prioritize chemicals in commerce. Docket EPA-HQ-OPPT-2016-0399
  • Risk Evaluation Procedural Rule, which will set forth the process EPA will use to conduct risk evaluations of high-priority and industry-requested chemicals. Docket EPA-HQ-OPPT-2016-0400
  • Rule Establishing Fees for the Administration of TSCA, which will detail how EPA will collect fees from companies to defray the costs of administering core activities under the new law. Docket EPA-HQ-OPPT-2016-0401

EDF filed comments yesterday on all three rules, available here, here and here.

Several of the key recommendations from each of our comments follow.   Read More »

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We appear to have gotten lucky in the January 2014 West Virginia chemical spill

By / Published: July 15, 2016

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

[UPDATE:  Please see additions below.  On reflection, my “got lucky” theme here may well have been a poor choice, as I certainly did not mean to imply that the spill was anything other than a nightmare for affected residents; rather, it was my attempt to again highlight the extent to which officials were flying blind at the time due to numerous systemic failures.  While the NTP study I discuss here answers some questions and I believe is cause for some relief, it did not address all concerns, leaves considerable uncertainty, and doesn’t begin to undo the damage of this incident and its continuing aftermath.  Apologies to anyone who took my phrase to imply otherwise.]

Readers may recall that I blogged extensively about the January 2014 spill of chemicals into the Elk River near Charleston from tanks used to store the chemical near the river’s edge, which disrupted the drinking water supply and the lives of 300,000 residents for many weeks thereafter.

A key concern was the dearth of health data – both publicly available and otherwise – on the key chemical components of the spilled mixture, which was used to wash coal.  As I reported in a series of blog posts, despite scant data, federal and state officials rushed to establish – and then defend their establishment of – a concentration of one part per million (1 ppm) as the “safe” level of the main component, 4-methylcyclohexanemethanol (MCHM), of the spilled mixture.  I pointed to the lack of a scientific basis for that level, largely because of the lack of adequate health information.

That remained the case even after the chemical’s producer, Eastman Chemical, decided to make public its studies of the chemical that it had hidden, claiming them to constitute trade secrets.  I tried to be careful not to claim MCHM or other spilled chemicals posed health risks, but rather that the lack of safety data was highly concerning, given the widespread extent of exposure.

Among the many outcomes of the spill was an agreement by the National Toxicology Program (NTP) to undertake a thorough study of the potential health and environmental effects of MCHM and other component chemicals.  That study is now complete, and the results were released last week.   Read More »

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