EDF Health

EPA sets interim limits on hypochlorite bleach to reduce degradation to perchlorate

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

On May 1, 2018, Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) made an interim pesticide registration decision[1] for hypochlorite bleach used to disinfect drinking water. The office decided to require the “Precautionary Statements” section of the bleach’s pesticide label to include advisory best management practices to minimize the formation of chlorate and perchlorate. The new label will state:

"The following practices help to minimize degradant formation in drinking water disinfection:

  • It is recommended to minimize storage time.
  • It is recommended that the pH solution be in the range of 11-13.
  • It is recommended to minimize sunlight exposure by storing in opaque containers and / or in a covered area. Solutions should be stored at lower temperatures. Every 5º C reduction in storage temperature will reduce degradant formation by a factor of two.
  • Dilution significantly reduces degradant formation. For products with higher concentrations, it is recommended to dilute hypochlorite solutions with cool, softened water upon delivery, if practical for the application."

EDF submitted comments in November 2017 supporting OPP’s proposed label changes and requesting specific changes to the language including making the advice to users mandatory. We also asked the agency to extend the changes to hypochlorite bleach used to treat produce and to disinfect food handling equipment.

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Also posted in Drinking Water, EPA, FDA, Food, Health Policy, Health Science, perchlorate / Tagged , , | Comments are closed

EDF and others take FDA to court to demand action on carcinogenic flavors petition

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

FDA’s priority must be resolving safety concerns with existing chemicals over approval of new ones.

On May 2nd, EDF and other consumer health advocates filed a lawsuit to force the Food and Drug Administration (FDA) to make a final decision on our food additive petition, which asked the agency to reverse its approvals of seven carcinogenic synthetic flavors. Earthjustice is representing EDF in this petition for a writ of mandamus to the court of appeals. We did not take this action lightly. However, with the statutory deadline for a decision passing more than 20 months ago, we saw little chance that FDA would act without court oversight.

Our food additive petition narrowly focused on one specific issue where the law and science were clear, and laid out our review of both the scientific literature and the law concluding that the seven chemicals were no longer safe. FDA formally accepted the petition for filing – essentially confirming it was complete – which triggered a 180-day deadline under the statute to make a final decision. That deadline passed in August 2016 without a decision by FDA.

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EPA reaffirms Lead-Safe Renovation, Repair, and Painting Rule, citing 150% to 500% payback

Tom Neltner, J.D.is Chemicals Policy Director

In April 2018, the Environmental Protection Agency (EPA) completed a thorough review of its Lead-Safe Renovation, Repair, and Painting Rule (RRP) promulgated a decade ago. This rule requires contractors and landlords to use lead-safe work practices when more than minor amounts of lead-based paint in homes built before 1978 are disturbed. It also applies to pre-1978 child-occupied facilities. This review was conducted pursuant to Section 610 of the Regulatory Flexibility Act because of RRP’s significant impact on more than 300,000 small businesses that perform more than 4 million affected projects each year.

EPA concluded that RRP, including several post-2008 amendments, “should remain unchanged without any actions to amend or rescind it.” As part of the review, the agency updated its economic analysis and found that the estimated annual societal benefits, primarily in improved children’s IQ, of $1.5 to $5 billion exceeds the $1 billion in estimated annual compliance costs. Those estimates translate into an impressive annual payback of 150% to 500%. Keep in mind that these benefits do not include the lower risk of premature cardiovascular deaths attributed to adult lead exposure in a March 2018 report in Lancet.

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Also posted in EPA, lead, Regulation / Tagged , , , , , | Comments are closed

FDA details its new push on heavy metals in food

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

In May 2017, the US Food and Drug Administration (FDA) Center for Food Safety and Nutrition (CFSAN) announced it had “established a Toxic Elements Working Group whose mission in part is to develop a strategy for prioritizing and modernizing the Center’s activities with respect to food/toxic element combinations using a risk-based approach.” FDA set a goal of limiting lead “to the greatest extent feasible.”

In April 2018, FDA released an interview with the Working Group’s chair, Conrad Choiniere, providing an update on its activities. An overarching point expressed by Choiniere during the interview is that “these metals [lead, arsenic, cadmium and mercury] can have effects on children’s neurological development.” This affirmation of scientific evidence is a welcome sign from the agency. FDA’s key statements are:

  • Initial scope: Children’s exposure to “metals like lead, arsenic, cadmium, and mercury in foods, cosmetics, and dietary supplements.”
  • Approach: “Looking at all the metals across all foods rather than one contaminant, one food at a time.”
  • Initial findings: “Even though the level of a metal in any particular food is low, our overall exposure adds up because many of the foods we eat contain them in small amounts.”
  • Next steps:
    • “Finalizing the draft guidance that sets an action-level for the presence of inorganic arsenic in infant rice cereals and apple juice.”
    • “Begin reevaluating the specific lead levels that FDA has set for a variety of foods.”

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Also posted in FDA, Food, lead / Tagged , , , | Comments are closed

EDF comments fault EPA for deviating from the law in proposal for states and health professionals’ CBI access

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

One of the key reforms to the Toxic Substances Control Act (TSCA) made by 2016’s Lautenberg Act was the expansion of who can access confidential business information (CBI) submitted by companies to EPA.  The old law largely limited access to federal government employees and contractors.  Congress recognized the enormous value such information could provide to officials at other levels of government and to health providers and environmental officials treating or responding to chemical releases and exposures.  It therefore mandated that EPA expand CBI access, subject to certain conditions specified in the law.

In March, a full 21 months after passage of the Lautenberg Act, EPA finally issued draft guidance documents setting forth how it intends to meet the law’s mandate to expand access to CBI.  Unfortunately, as has been the case with so many other aspects of TSCA implementation under the Trump administration, EPA got a lot of things wrong in its draft guidance documents.

Yesterday, EDF filed extensive comments raising our concerns over these serious deviations from the law and providing our recommendations for fixing them.   Read More »

Also posted in EPA, Health Policy, TSCA Reform / Tagged , | Comments are closed

Washington State takes action to eliminate use of PFAS in food packaging

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

Around 1990, driven by a concern to keep heavy metals out of recycled products, many states adopted laws prohibiting the intentional addition of arsenic, cadmium, lead, and mercury to packaging and limited their total concentration to 100 parts per million. Manufacturers and suppliers of packaging and packaging components in these states were also both required to furnish a Certificate of Compliance to the packaging purchaser and provide a copy to the state and the public upon request. The Toxics in Packaging Clearinghouse currently reports that 19 states have adopted this type of legislation.

Out of concern about consumer’s health and contamination of compost, on February 28, 2018, Washington State extended its heavy metal packaging law in a groundbreaking way. The legislature passed HB-2658 banning the intentional use of “perfluoroalkyl and polyfluoroalkyl substances” (PFAS) in food packaging made from plant fibers, pending a determination by the Washington Department of Ecology that safer alternatives are available. The law defines PFAS as “a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.”

The ban goes into effect in 2022 or two years after the Department makes the safer alternative determination, whichever is later.[1] If, after evaluating the chemical hazards, exposure, performance, cost, and availability of alternatives, the Department does not find safer alternatives by 2020, it must update its analysis annually. We anticipate that this approach will spur innovation among companies offering alternatives and provide a thoughtful and rigorous review of the options.

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Also posted in FDA, Food, Health Policy, Health Science, States / Tagged , , , , | Comments are closed