EDF Health

At last: EPA promulgates nanomaterial reporting rule

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

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 »

Also posted in Emerging science, FDA, Food, Perchlorate, Regulation / Tagged , , , , , , , | Comments are closed

Cincinnati and Ohio show leadership in identifying and disclosing lead service lines

Tom Neltner, J.D.is Chemicals Policy Director

Transparency is an essential aspect of any successful program to reduce lead in drinking water. Knowing if you have a lead service line (LSL)—the pipe that connects the main under the street to the building—can help you decide whether to use a filter or replace the line. If you are looking for a home to rent or buy, the presence of a LSL can be a factor in your choice. Transparency can also help reassure consumers that their utility is aware of the problem and committed to protecting their health. The challenge for many water suppliers is that they often don’t have perfect information about the presence of LSLs. But incomplete information is not a reason for failing to disclose what is known, what is uncertain, and what is unknown.

In a February 29, 2016 letter to the states, U.S. Environmental Protection Agency (US EPA) asked states to increase transparency by posting on either the state’s website or have it posted on local utilities’ websites:

“the materials inventory that systems were required to complete under the [Lead and Copper Rule] including the locations of lead service lines [LSLs], together with any more updated inventory or map of lead service lines and lead plumbing in the system.”

In response to this letter and systemic issues brought to light about lead in drinking water in the village of Sebring, Ohio and Flint, Michigan, the State of Ohio enacted pragmatic legislation crafted by Governor John Kasich’s administration and the Ohio Environmental Protection Agency (Ohio EPA). Among its supporters was the Ohio Environmental Council. One provision in the law requires community water systems to

“identify and map areas of their system that are known or are likely to contain lead service lines and identify characteristics of buildings served by the system that may contain lead piping, solder, or fixtures . . .”

Utilities must submit the information to Ohio EPA as well as the departments of Health and of Job and Family Services by March 9, 2017 and update this information every five years.

Read More »

Also posted in Drinking water, Lead, Regulation / Tagged , , , , , , , , | Authors: / Read 2 Responses

Government, NGOs, and industry gather for EPA TSCA New Chemicals Review Meeting

Joanna Slaney is the Legislative Director for EDF Health.

[UPDATE 1/17/17:  Today EPA posted a full transcript of the public comments made at its December 14, 2016, meeting, along with the presentations made by EPA staff.  MP3 audio files of the public comments are already posted (note they are huge files).]

EPA held a public meeting Wednesday on the implementation of the New Chemicals Review Program under the reformed Toxic Substances Control Act (TSCA). The Frank R. Lautenberg Chemical Safety for the 21st Century Act required EPA to begin implementation of the reforms to the program on the day the legislation was signed into law. The meeting was an opportunity to discuss the effort and progress to date.

As we’ve noted before, and as I noted on Wednesday, the changes made to the New Chemicals Review Program were fundamental to TSCA reform and the promise of a new system that better protects public health and the environment.

Representatives from state government, the Senate, NGOs, and industry gathered to hear a series of presentations by EPA about new chemicals reviews under the reformed law, scientific and data issues the Agency is navigating, and the types of information it needs from manufacturers and processors to facilitate a streamlined review process.

A series of oral comments from various stakeholders included a robust showing of support for EPA’s actions from public interest groups representing labor, the environment, and public health, as well as concerns from some in industry with certain aspects of implementation. EPA concluded with a commitment to meet again in six months to discuss its progress in implementing revisions to the New Chemicals Review Program.

Read More »

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

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

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, Perchlorate, Regulation / Tagged , , , , , , , , | Comments are closed

Remarks at EPA stakeholder meeting on New Chemicals Review Program

Joanna Slaney is the Legislative Director for EDF Health.

Today the EPA held a public meeting on the new requirements for the New Chemicals Review Program under the reformed Toxic Substances Control Act. EDF oral comments, as prepared for delivery, follow below.

Strong implementation restores public and market confidence.

EDF believes that the reforms to the New Chemicals program in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, and the robust implementation of these reforms by the EPA, are absolutely essential to the task of restoring public and market confidence in our national chemical safety system. It is this shared objective, restoring public and market confidence, that allowed disparate stakeholders and lawmakers to come together to support the Lautenberg Act in the first place. And without a strong New Chemicals program, there is no restored public confidence.[pullquote]Without a strong New Chemicals program, there is no restored public confidence.[/pullquote]

It’s a public health issue.

With between 500 and 1,000 new chemicals entering the market every year, ensuring the safety of these chemicals is clearly a public health priority. It is critical that new chemicals clear a safety bar before they are allowed in products and in our homes. For decades, chemicals have been allowed on the market simply because there wasn’t enough information to make a safety decision one way or another. In 2007 EPA reported that 85% of pre-manufacture notices contained no health data. That’s not right, and it puts the public’s health at risk, most especially the health of vulnerable populations like children, pregnant women, and workers. Any chemical entering the market should be reviewed and managed to provide a reasonable assurance of its safety. In fact, I expect that most Americans believe that their government already does so in order to protect their health and the health of their families.

It’s congressional intent.

Many in Congress worked hard to drive significant improvements to the new chemicals provisions in the new law; indeed, for some it was a central reason for their involvement in reforming TSCA. And the record is clear that even where certain Members were less inclined to see the need for change, they acknowledged that significant changes were made to the New Chemicals program as part of the compromise legislation. The changes that were made were a compromise on both sides but they were not insignificant, and the new requirements are clearly laid out in the language of the Lautenberg Act.

It’s a primary purpose of TSCA.

It has been argued that EPA’s implementation of the new chemicals program under the Lautenberg Act risks impeding innovation and is at odds with the intent of the law. In fact, the intent of the law is quite clear:

It is the policy of the United States that— authority over chemical substances and mixtures should be exercised in such a manner as not to impede unduly or create unnecessary economic barriers to technological innovation while fulfilling the primary purpose of this Act to assure that such innovation and commerce in such chemical substances and mixtures do not present an unreasonable risk of injury to health or the environment.

While innovation is central, it cannot come at the expense of protection for public health and the environment. Innovation without safety is not true innovation.

The changes made to the New Chemicals program are fundamental to the reform of TSCA and the promise of the new system. Given that the development and application of new chemicals are a clear source of innovation, how else is that primary purpose of TSCA – providing an assurance that innovation and commerce in chemicals do not present unreasonable risk – to be realized other than through robust scrutiny of new chemicals prior to their commercialization.

The public has a right to expect that chemicals to which they may be exposed will not be allowed into use without adequate assurance of their safety.  The lack of that basic assurance has undermined consumer confidence in our chemical safety system.  The most efficient and effective stage at which to provide assurance of safety is before commercial production and use begins, rather than waiting and then having to try to mitigate risks that arise after a new chemical is embedded in commerce.

Environmental Defense Fund supports the actions taken by EPA to date in implementing the New Chemicals Program and believes they are clearly required under the new law.  We look forward to EPA continuing to implement a robust New Chemicals program that can restore public and market confidence in our national chemical safety system, while both protecting human health and the environment and fostering safe innovation.

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