Selected category: Regulation

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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Washington Post looks at the long and painful history of Lead in Drinking Water rule

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

If you missed last week’s Washington Post piece, “The EPA’s lead-in-water rule has been faulted for decades. Will Flint hasten a change?”  we suggest you go back and take a look. Post reporter Brady Dennis takes us back to the beginning to figure out how a federal rule intended to help ensure safe drinking water nationwide faltered, and why it has taken so long to fix.

In 1991, EPA issued the Lead and Copper Rule to reduce lead in drinking water that primarily relied on corrosion control. But initial progress stalled and the rules shortcomings became clear. As EPA Administrator Gina McCarthy explained at a recent hearing, the rule “needs to be strengthened.” Critics claim the outdated rule has become too easy to evade and too hard to enforce.

EPA now is developing an overhaul of the rule. Given the complexity and scope of the challenge, as my colleague Tom Neltner points out, the stakes are high and the agency needs to get it right.

Neltner should know. He served on the expert panel advising the EPA National Drinking Water Advisory Council (NDWAC) which looked at the rule’s flaws. For example, EPA’s original “lead action level” was based on whether or not corrosion control was working and not on the health risk. The group Neltner served on recommended establishing a new health-based “household action level” that will empower people to make informed choices about how to manage their risk to lead hazards in water. In February 2015, EPA agreed to develop an estimated level for the panel to consider. Given the consumer’s need for the number as a result of Flint, EDF has urged that the agency move quickly to release the household action level.

EPA has indicated the lead rule update will be issued in 2017. But with bipartisan Hill support and a new Presidential Administration on the horizon, many are anxious to see it move faster.

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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 »

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Unfulfilled: EPA’s 2009 commitment to fix lead-based paint hazard standard

In 2009, EPA committed to fix its rule identifying dangerous levels of lead. The evidence since then has only gotten more compelling. EPA needs to fulfill its commitment and revise the rule consistent with the recommendations of its own Science Advisory Board.

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

In 2005, then-Senator Barack Obama, supported by then-Senator Hillary Clinton, forced the Bush administration to issue a long-overdue rule to ensure contractors used lead-safe work practices when conducting renovations, repairs, and painting work at homes and child-occupied facilities. So when Senator Obama became President Obama, there was tremendous promise for advances in lead poisoning prevention.

By the second half of 2009, it appeared that promise was turning into reality. Under President Obama’s leadership, the Environmental Protection Agency (EPA) made lead poisoning prevention a priority and undertook a series of important commitments to protect children. Despite that initial success, many of those prevention efforts were foundering by late 2010. Read More »

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Lead hazard disclosure: Time to be better inform home buyers and renters

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

Imagine what would happen if firms like Zillow and Redfin that have transformed the real estate marketplace also helped consumers make informed decisions about health hazards in the home.

In the past 20 years, if you’ve bought or rented a home built before 1978, you’ve seen it–130 words in a dense paragraph titled “Lead Warning Statement.” Below it, the landlord or seller most likely checked the box saying he or she “has no knowledge of lead-based paint and/or lead-based paint hazards in the housing” and “has no reports or records pertaining to lead-based paint and/or lead-based paint hazards in the housing.”

By the time you read that dense paragraph, you’d have already chosen your new home, so you likely signed the forms and put the “Protect Your Family from Lead in Your Home” booklet in your to-do pile; a pile that all-t0o-easily gets lost in the chaos of a big move.

Congress created this lead hazard disclosure requirement in 1992 as part of a comprehensive law designed to protect children from lead in paint. The objective was to transform the marketplace by having buyers and renters demand homes that were either free of lead paint or, at least, lead hazards.

It has not worked out that way. The marketplace for lead-free or lead-safe homes never materialized, and sellers and landlords have little to no incentive to look for problems that might complicate the transaction.

Read More »

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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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