EDF Health

FDA agrees to reconsider safety of ortho-phthalates

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 13, 2016

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 »

Also posted in FDA, Food, Health policy, Phthalates / Tagged , , , , , , , , , | Authors: / Comments are closed

EPA moves one step closer to managing risks from TCE

By Lindsay McCormick / Published: April 11, 2016

Lindsay McCormick is a Research Analyst.

It’s no secret that trichloroethylene (TCE) is a nasty chemical.  A 2013 review of thousands of scientific studies by Environmental Protection Agency (EPA) scientists concluded that TCE is carcinogenic to humans by all routes of exposure and poses additional hazards, including immunotoxicity, neurotoxicity, and adverse effects on the developing heart.  TCE’s link to cancer has been confirmed by the International Agency for Research on Cancer (IARC), EPA’s Integrated Risk Information System (IRIS),  the Agency for Toxic Substances and Disease Registry (ATSDR), and the National Toxicology Program (NTP).

With such a track record, one would expect that the U.S. government has restricted its use, right?  Wrong.  The current annual U.S. production of TCE is 250 million pounds – so, not surprisingly, human and environmental exposure is widespread.  While most TCE is used in industrial and commercial settings as a chemical intermediate in the production of other chemicals, it’s also commonly used as a metal degreasing agent and spot cleaner in commercial dry cleaning, and can be found in certain consumer products. Read More »

Also posted in Health policy / Tagged , , | Comments are closed

No Safe Level: Old pipes and paint threaten the health of America’s children

By Sarah Vogel / Published: April 7, 2016

Sarah Vogel, Ph.D., is Vice-President for Health.

Since the crisis in Flint hit the national headlines, the problem of lead exposure from drinking water has come under greater scrutiny. And for good reason. Seven to ten million American homes have water delivered through service lines made of lead pipe – the primary source of lead in drinking water. But the events in Flint also highlight the fact that despite decades of decline in the levels of lead in the blood of American children, we still have a lead problem in this country. Given that there is no safe level of exposure to lead, we have a lot of work to do. The current crisis offers a new opportunity to make significant progress, and we have a record of past achievement to learn from and build upon.

Forty years ago over 13 million young children in American had blood lead levels at or above 10 micrograms per deciliter (µg/dL). By 2000, that number had decreased to just under a half a million. The greatest reductions made were among low income and children of color who had the highest blood lead levels. As a result of such significant progress, many declared victory and organizations, including EDF, shifted their focus to other environmental health issues leaving considerable work still to be done on lead.

While blood lead levels were declining, scientific evidence was mounting to show there is no safe level of exposure to lead in infants and young children. Studies showed that adverse neurological effects were happening at lower and lower levels of lead exposure. In 2012, the Centers for Disease Control and Prevention reduced the level of lead in blood used to identify those with elevated exposure to 5 µg/dL. Today, approximately 500,000 children have levels at or above 5 µg/dL.

Despite the major declines in children’s blood lead levels at or above 10 µg/dL and decreases in racial and income disparities since the mid-1970s, progress has stalled over the past decade. And still disparities persist. Children living in poverty remain at the greatest risk. Indeed, children in poor households are three times more likely, and African-American children are twice as likely as white children, to have elevated blood lead levels. Read More »

Also posted in Drinking water, Health policy, Health science, Lead / Tagged , , , , | Read 2 Responses

FDA sued for delay in deciding perchlorate food additive petition

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 31, 2016

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

[pullquote]At the end of 2014, FDA agreed to consider a food additive petition from NGOs to ban perchlorate – a chemical that can impair a child’s brain development – as an additive to food packaging. The agency had 180 days to act, but fifteen months later, the petitioners are still waiting for a response. Today, they sued.[/pullquote]

It’s been 15 months since a group of environmental, consumer, and public health advocates petitioned the Food and Drug Administration (FDA) to remove the agency’s approval of perchlorate uses in packaging.

Traditionally, FDA’s food additive petition process has been the exclusive purview of food manufacturers seeking approval to use new chemicals or expand uses of already approved chemicals in food production. However, nothing in the law prohibits the public from using the process to ban or restrict the use of certain chemicals. Read More »

Also posted in Drinking water, FDA, Food, General interest, Health policy, Perchlorate / Comments are closed

FDA decides 3 PFCs are unsafe: Detailed look at the decision

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 11, 2016

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

FDA’s decision to remove its approval of three long-chain perfluorinated compounds sets important precedents on the assessment of food ingredients, food contact substances, and chemicals used to make food.

[pullquote]

FDA concluded:

  • Class: All long-chain chemicals with at least one linear, perfluorinated chain of eight or more carbon atoms should be considered a class.
  • Data gaps: Where reproductive and developmental toxicity data are lacking for any chemical in this class, the data available for perfluorinated octanoic acid (PFOA) should be used to fill the gaps.
  • Study methods: If a chemical is biopersistent in the body, standard toxicology methods used to evaluate food additives need to be upgraded.

[/pullquote]On Jan. 4, 2016, the Food and Drug Administration (FDA) announced that it changed its regulations to remove the agency’s approval of three specific long-chain perfluorinated compounds (PFCs) as food additives. The agency approved use of these chemicals between 1967 and 1997, allowing them to be added to paper and paperboard that comes in contact with aqueous and fatty foods. Until the late 2000s, they were commonly used in pizza boxes, sandwich wrappers, and paper in frozen food packaging – virtually anywhere a food manufacturer wanted to use paper packaging that would repel oil and water.

Domestic PFC manufacturers report that these food contact substance (FCS) uses have been abandoned, although others report trace levels still appearing in paper products used for food, most likely as a result of contamination. There are reports, however, that foreign companies have begun producing PFCs. As long as these additives are officially allowed by FDA, there is a possibility that food manufacturers who are not diligent could resume their use without knowing it. The agency’s decision makes it less likely that will happen.

FDA’s decision marks the first time it has used a food additive petition to remove an approval based on safety concerns; a few years ago, it removed approvals for use of bisphenol A in infant formula packaging and baby bottles and sippy cups – but those removals were based on market abandonment, not safety. This safety-driven decision sets a precedent and serves as a roadmap for how safety decisions should be made for all additives including those considered by industry to be ‘generally recognized as safe’ (GRAS).

No longer safe – unpacking the agency’s reasoning for a class of chemicals and safety concerns Read More »

Also posted in Emerging science, Emerging testing methods, FDA, Food, Health policy, Health science / Tagged | Comments are closed

Why is the nanotech industry so intent on keeping EPA from doing its job?

By / Published: August 20, 2015

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

Ten years and counting.  That’s how long EPA has been trying to gather the most basic information on nanoscale materials in commerce.  And that’s how long the nanotech industry has been throwing up roadblocks – despite its rhetoric that it supports EPA’s effort, which it sees (in theory) as a means to “favorably and efficiently address unwarranted concerns that have been raised” about the products of nanotechnology.  This “say-one-thing, do-another” approach is both unfortunate and ironic, given that it has stymied getting to a well-informed government oversight system for nanotechnology that the industry should recognize is in its own best interest.

The latest round comes in the wake of EPA’s proposal of a reporting rule under the Toxic Substances Control Act (TSCA) that would call on makers and processors of nanoscale materials – those in the size range of 1-100 nanometers (nm) – to provide the agency with information relating to the materials’ manufacture, processing and use, as well as available data relevant to understanding their potential exposures and health or environmental impacts. Here’s EPA’s succinct summary of the rationale for the rule:

Nanoscale materials have special properties related to their small size such as greater strength and lighter weight, however, they may take on different properties than their conventionally-sized counterpart. The proposal is not intended to conclude that nanoscale materials will cause harm to human health or the environment; Rather, EPA would use the information gathered to determine if any further action under the Toxic Substances Control Act (TSCA), including additional information collection, is needed.

Despite this modest, common-sense objective, the proposal was met with vociferous opposition from the nanotech industry.   Read More »

Also posted in Health policy, Nanotechnology / Tagged , | Read 2 Responses