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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 »

Posted in Emerging Science, FDA, Food, Health Policy, perchlorate, Regulation / Also 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.

Posted in Drinking Water, Emerging Science, EPA, FDA, Food, Health Policy, perchlorate, Regulation, Uncategorized / Also 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 »

Posted in FDA, Food, GRAS, Health Policy, Regulation / Also tagged , , , | Comments are closed

FDA accepting public comments on the safety of ortho-phthalates

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

Today, the Food and Drug Administration (FDA) announced it was accepting public comment on a food additive petition asking the agency to reconsider the safety of 30 toxic chemicals known as ortho-phthalates, which are used as additives in food packaging and handling materials.

The announcement, to be published in tomorrow’s Federal Register, comes shortly after a new study by Dr. Ami Zota published in the journal Environmental Health Perspectives found that individuals who consume large amounts of fast food have higher levels of exposure to two of the most commonly-used phthalates—diethylhexyl phthalate (DEHP) and diisononyl phthtlate (DiNP). Because the study was about fast food, final food packaging is less likely to be a major source than food handling equipment, including gloves. Read More »

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Senator Markey asks: What if people could buy food they know is free of secret ingredients?

Senator Markey (D-MA) asked FDA if it can require a label to tell consumers when the food they are eating contains chemicals it has not reviewed for safety. In his April 26 letter, he asked the agency to respond by May 17.

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

In May 2015, 36% of consumers said that chemicals in food was their most important food safety issue and 23% of consumer said they changed their purchase habits out of concern with chemicals in their food. Leading food manufacturers responded by reformulating their products to remove artificial flavors and colors.

What if these same consumers knew that chemicals added to their food had not been reviewed for safety by the Food and Drug Administration (FDA)? As the Natural Resources Defense Council made clear two years ago, 56 food additive makers chose to avoid FDA’s scrutiny by taking advantage of a loophole in the law for “Generally Recognized as Safe” (GRAS) substances. They purposely chose not to be transparent by keeping secret the safety evaluation conducted by their employees or consultants. These companies appear to make only a few of the estimated 1000 chemicals that FDA has not checked for safety or is aware they exist.

In February, we learned that 51% of consumers think that safety means not only that a product is free of harmful ingredients but that its labeling is clear and accurate. Forty-seven percent want clear information on ingredients and sourcing. With this in mind, it’s fair to assume that consumers also expect that all food chemicals are safe and known to the FDA. Many consumers would likely not buy products where the labeling failed to disclose that the food they serve their families contained ingredients the FDA has admitted it “cannot vouch for their safety".

On April 26, Senator Edward Markey (D-MA) put the issue front and center when he asked FDA whether it has “sufficient authority to require a special label on any foods or beverages containing ingredients that have been self-determined to be GRAS without an FDA review?” If FDA had sufficient authority, then “what would the label look like?” Read More »

Posted in FDA, Food, GRAS, Markets and Retail, Regulation, Uncategorized / Also tagged , , , | Comments are closed

FDA agrees to reconsider safety of ortho-phthalates

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

Yesterday, the Food and Drug Administration (FDA) agreed to consider withdrawing its approvals of 30 food additives known as ortho-phthalates from use in food packaging and food handling equipment.  The chemicals are in a class of chemically- and pharmacologically-related substances used as plasticizers, binders, coating agents, defoamers, gasket closures, and slimicide agents to process and package food. The agency allows them to be used in cellophane, paper, paperboard, and plastics that come in contact with food. All of the chemicals were approved by the agency before 1985.  Pursuant to 21 U.S.C. 321(s), chemicals that are reasonably expected to get into food from their intentional use in materials contacting food are considered "food additives."

FDA acted in response to a food additive petition submitted by the Natural Resources Defense Council, Center for Science in the Public Interest, Center for Environmental Health, Center for Food Safety, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids’ Environment, and Learning Disabilities Association of America – groups all concerned by the adverse health effects of ortho-phthalates at the levels typically seen in food.

Academic studies have linked some of these chemicals to various reproductive, developmental and endocrine health problems. In fact, every ortho-phthalate that has been studied for these types of health effects has been found to pose a risk. From lower IQ in young children to malformation of the male genital tract, the evidence of health effects in humans continues to grow. But, with more than half of the 30 chemicals lacking any published safety data, the full extent of the threat remains unclear.

Read More »

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