Selected category: FDA

EPA to consider perchlorate risks from degradation of hypochlorite bleach

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

Virtually all types of food contain measurable amounts of perchlorate. Young children are the most highly exposed, and they consume levels that may be unsafe. Reducing exposure to perchlorate is of public health importance because it presents a risk to children’s brain development

One potentially significant source of the toxic chemical in food is hypochlorite bleach that, when not well managed, degrades to perchlorate. Bleach is used to sanitize food manufacturing equipment or to wash or peel fruits and vegetables. Thanks to a recent decision by Environmental Protection Agency’s (EPA) Office of Pesticide Programs, we will better understand the risk posed by perchlorate-contaminated bleach and whether standards are needed to improve the management of bleach.

Reduce perchlorate exposure by improving bleach management

In 2011, an excellent report by the American Water Works Association (AWWA) and the Water Research Foundation documented that hypochlorite bleach degrades into perchlorate. The report also included guidelines on better management of hypochlorite to preserve its effectiveness for drinking water utilities using it to disinfect water.

Most of AWWA’s recommendations are equally relevant to food manufacturers and anyone using bleach to disinfect food contact surfaces. The key recommendations are:

  • Dilute hypochlorite solutions on delivery. Cutting the concentration in half decreases the degradation rate by a factor of 7.
  • Store hypochlorite solutions at lower temperatures. Reducing temperature by 5oC decreases degradation rate by a factor of 2.
  • Keep pH between 11 and 13 even after dilution.
  • Avoid extended storage times, and use fresh hypochlorite solutions when possible.

The objective is not to reduce the use of bleach. Rather it is to preserve its effectiveness by preventing degradation to perchlorate through careful management.

Bleach: a food additive and a pesticide

Read More »

Also posted in Drinking Water, Emerging Science, Food, perchlorate, Regulation| Tagged , , , , , , | Comments are closed

When it comes to lead, formula-fed infants get most from water and toddlers from food, but for highest exposed children the main source of lead is soil and dust

Tom Neltner, J.D.is Chemicals Policy Director

On January 19, the Environmental Protection Agency (EPA) released a major new draft report proposing three different approaches to setting health-based benchmarks for lead in drinking water. We applauded EPA’s action and explored the implications for drinking water in a previous blog. One of the agency’s approaches provides useful, and surprising, insights into where the lead that undermines the health of our children comes from. Knowing the sources enables regulators and stakeholders to set science-based priorities to reduce exposures and the estimated $50 billion that lead costs society each year.

The EPA draft report is available for public comments until March 6, 2017, and it is undergoing external peer-review by experts in the field in support of the agency’s planned revisions to its Lead and Copper Rule (LCR) for drinking water. Following this public peer-review process, EPA expects to evaluate and determine what specific role or roles a health-based value may play in the revised LCR. With the understanding that some of the content may change, here are my takeaways from the draft:

  • For the 20% of most exposed infants and toddlers, dust/soil is the largest source of lead. Since we know that 21% of U.S. homes (24 out of 114 million) have lead-based paint hazards, this should not be surprising.
  • For most infants, lead in water and soil/dust have similar contributions to blood lead levels, with food as a smaller source. If the infant is formula-fed, water dominates.
  • For 2/3 of toddlers, food appears to provide the majority of their exposure to lead. This result was a surprise for me. EPA used data from the Food and Drug Administration’s (FDA) Total Diet Study collected from 2007 to 2013 coupled with food consumption data from the National Health and Nutrition Examination Survey collected from 2005 to 2011. In August 2016, FDA reported on levels of lead (and cadmium in food) commonly eaten by infants and toddlers based on a data set that is different from its Total Diet Study. FDA concluded that these levels, “on average, are relatively low and are not likely to cause a human health concern.”
  • For all children, air pollution appears to be a minor source of lead exposure. We think it is most likely because exposure is localized around small airports and industrial sources.

For a visual look at the data, we extracted two charts from the draft EPA report (page 81) that show the relative contribution of the four sources of lead for infants (0-6 month-olds) and toddlers (1 to <2 year-olds) considered by the agency. The charts represent national exposure distributions and not specific geographical areas or age of housing.

Read More »

Also posted in Drinking Water, Emerging Science, EPA, Food, Health Policy, lead| Tagged , , , , , , | Comments are closed

Too many young children get too much perchlorate from food

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

On January 9, we described a new Food and Drug Administration (FDA) report showing that perchlorate exposure to infants and toddlers increased 34% and 23% respectively between the years around 2005 and 2010. Young children were the most exposed age groups. FDA compared the exposure to a “safe dose” established in 2005 and saw no cause for concern. We respectfully disagree and find the levels alarming. First, we now know that the 2005 “safe dose” is no longer sufficient to protect children’s brains from the irreversible harm that can result from even transient exposures to perchlorate. Second, many young children may be over the “safe dose.” Read More »

Also posted in Drinking Water, Food, Health Policy, perchlorate, 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, Food, Health Policy, perchlorate, Regulation| 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, EPA, Food, Health Policy, perchlorate, Regulation, Uncategorized| Tagged , , , , , , , , | Comments are closed

Lost opportunity for safer food additives

In DC, “Take Out the Trash Day” refers to federal agencies releasing unpopular decisions on Friday when the media and public are not watching.  It is especially common around the holidays or in August when many people, especially those in Congress are on vacation.  On Friday, August 12, FDA took out the trash by issuing a final rule regarding chemicals added to food more than two weeks before a court ordered deadline

Tom Neltner, J.D.is Chemicals Policy Director

On August 12, the Food and Drug Administration (FDA) issued a final rule defining how companies should voluntarily notify the agency when they conclude that a chemical added to or used to make food is “Generally Recognized as Safe” (GRAS).

The decision is a lost opportunity to close a widely-abused loophole that allows chemicals to be approved for use in food with no notification to or review by FDA. The rule allows the industry to continue making secret decisions about what we eat without the agency’s – or the public’s – knowledge.  The agency has the legal authority to significantly narrow the GRAS loophole to prevent companies from deliberately avoiding FDA’s safety review process.

Just two years ago, the senior FDA official overseeing food safety acknowledged that the agency “cannot vouch for the safety of many of these chemicals” as a result of the GRAS loophole. Read More »

Also posted in Food, GRAS, Health Policy, Regulation| Tagged , , , , | Comments are closed
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