EDF Health

FDA’s Failure on Food Chemical Safety Leaves Consumers at Risk of Chronic Diseases

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

More than 60 years ago, Congress enacted legislation requiring the Food and Drug Administration (FDA) and the food industry to evaluate the cumulative effects of substances in the diet that have related health impacts when assessing the safety of chemical additives. In our decade of analyzing FDA and industry actions, we have been increasingly concerned that both have ignored this requirement. To figure it out, we investigated all safety determinations contained in Generally Recognized as Safe (GRAS) notifications voluntarily submitted by food manufacturers to FDA since the program began in 1997. We looked at GRAS notices because they are publicly available and because FDA rules explicitly require that food manufacturers include in the notice an explanation of how they considered the requirement. If there was an omission, it would be more easily noticeable.

We found that in only one of 877 GRAS notices did a food manufacturer consider the cumulative effect requirement in a meaningful way. And we found no evidence that the agency either recognized this single attempt to follow the law or had objected to the omissions in the 876 other notices. This failure has significant consequences for public health, particularly for communities who already face significant health and socio-economic disparities, and for children, who are uniquely susceptible to dietary exposures to multiple chemicals.

For this reason, EDF joined with other health, environmental, and consumer groups to file a formal petition to demand FDA and food manufacturers start following the law. The petition requests specific changes to rules designed to reinforce the existing requirement and make it easier to verify compliance. Still, given the lack of transparency in agency reviews, success still largely depends on FDA and the food industry taking seriously the mandate and the food safety implications.

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FDA takes an important step by phasing out paper greaseproofing agents containing a specific PFAS

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

Last week, the Food and Drug Administration (FDA) announced the phase-out of per- and polyfluorinated alkyl substances (PFAS) used to greaseproof paper and paperboard food packaging made from a specific type of short-chain PFAS known as 6:2 fluorotelomer alcohol (6:2 FTOH).  The action, narrow as it is, is welcome news for efforts to protect public health and the environment from the risks posed by short chain PFAS, known as “forever chemicals” because they do not degrade.

FDA secured voluntary agreements with three companies, Archroma, Asahi Glass, and Daikin, to phase-out products based on 6:2 FTOH. A fourth company, Chemours, asked FDA to suspend the agency’s approvals on its products containing the PFAS one year ago. The action affects 15 food contact substance notifications (FCN) approved by the agency between 2006 and 2016. It does not address 13 FCNs for similar greaseproofing uses made from PFAS other than 6:2 FTOH. And, under the agreement, consumers may still find 6:2 FTOH-laden, carry-out containers until June 2025.

The process FDA took, and the time it took to get there, reveals the significant difficulties the agency has in reversing past actions in the face of mounting evidence of a chemical’s risk:

  • FDA must seek out information because companies have no obligation to affirmatively notify the agency of new studies showing potential problems;
  • When FDA finds the information and identifies potential safety concerns, it appears to act as if it has the burden of proving the use is no longer safe; and
  • FDA continued approving uses of 6:2 FTOH even after it identified problematic data gaps.

These difficulties reinforce the need for actions being taken by states such as Washington, Maine, New York, and California, by Congress, and by retailers to reduce uses of PFAS in their products. When it comes to food packaging, PFAS are dinosaurs and their time is running out.

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Revised national standard tightens lead leaching limits for new drinking water fixtures

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

Effective today, the national consensus standard for plumbing devices, known as NSF/ANSI/CAN 61, was revised to require, by January 1, 2024, that manufacturers of faucets and fountains that dispense drinking water meet limits five times more protective for lead leaching than the current standard. Manufacturers have the option to have their products tested and certified to the revised standard beginning in the fall, after it is published. All states require plumbing devices comply NSF/ANSI/CAN 61.

Plumbing Manufacturers International (PMI), the trade association for the industry, tells us that its members are already gearing up to get their products certified, but that it will take time to complete the third-party review process and meet the expected demand. Consumers, retailers, and institutional buyers should begin requesting products that meet the new standard – which can be identified by the new “NSF/ANSI/CAN 61: Q ≤ 1”[1] text on the consumer-facing product label – in 2021 as the certification process ramps up.

A driving force for this change was legislation introduced by California Assembly Member Chris Holden, cosponsored by EDF and Environmental Working Group, with productive and collaborative engagement from PMI and NSF International.[2] On June 8, the Assembly unanimously passed AB 2060. It now moves to the Senate for consideration. The current version of the bill would require that all devices made or sold in California that are intended to convey or dispense drinking water meet the new NSF/ANSI/CAN 61 standard on a faster timeline – by January 1, 2021. PMI has requested an effective date of January 1, 2024 for the California requirement to provide manufacturers, third party certifiers, distributors, and retailers with adequate time to get products certified and in stock in the state. Stakeholders are considering the request but are concerned that child care facilities and schools will need the devices sooner. Because of the legislation, we expect that manufacturers, wholesalers, and retailers will prioritize the California market.

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Michigan utilities report much lower percentages of service lines of lead or unknown material than Wisconsin or Illinois

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

Note to readers: As we all grapple with the grave global health challenge from COVID-19, we want to acknowledge the essential service that the public health professionals at water utilities provide in delivering safe water not only for drinking but for washing our hands and our surroundings. In the meantime, we are continuing to work towards improved health and environmental protections – including reducing lead in drinking water. We’ll plan to keep sharing developments regarding lead in drinking water that may be useful to you. In the meantime, please stay safe and healthy.

Lead service line (LSL) inventories provide useful insights into the location and number of LSLs in states and the funding needed to fully replace these lines. In previous blogs, we examined mandatory reporting by utilities of service line material in Illinois and Wisconsin.[1] Here, we examined a March 2020 preliminary report by the Michigan Department of Environment, Great Lakes, and Energy (EGLE) summarizing data submitted by 1,029 utilities. Unlike the annual reporting in Illinois and Wisconsin, Michigan required utilities to submit a preliminary inventory by January 1, 2020 and requires a complete inventory before 2025. While the preliminary report allows lines to be designated as unknown, the material must be determined by 2025. This is a two-step process, rather than the annual report approach that California has taken.

Michigan reports less than 100,000 LSLs and 276,000 lines of unknown material that may be lead

The state’s preliminary report is based on 1,029 utilities[2] (74% of the state’s 1,386 total) with 2.40 million service lines (90% of the 2.66 million total).[3] This reporting rate is lower than what Illinois experienced at a similar stage in the first year of mandatory reporting.

For the 1,029 utilities that reported, utilities reported 99,000 (4% of total) lead, 21,000 (0.9%) galvanized steel,[4] 177,000 (7%) of unknown material but likely to be lead, and 276,000 (12%) as unknown with no information. If all of the four categories are actually lead (which is unlikely), there would be 573,000 (23%) LSLs in Michigan.

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Latest Wisconsin data on water service lines provides important insights, reveals over 150,000 lead pipes

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

Note to readers: As we all grapple with the grave global health challenge from COVID-19, we want to acknowledge the essential service that the public health professionals at water utilities provide in delivering safe water not only for drinking but for washing our hands and our surroundings. In the meantime, we are continuing to work towards improved health and environmental protections – including reducing lead in drinking water. We’ll plan to keep sharing developments regarding lead in drinking water that may be useful to you. In the meantime, please stay safe and healthy.

With the comment period now closed on the Environmental Protection Agency’s proposed revisions to its Lead and Copper Rule (LCR), agency staff are busy reviewing the 687 distinct comments submitted to the docket with a goal of finalizing the rule by the end of the year. To help water professionals plan ahead, the cover article in the March edition of Journal AWWA walks readers through the proposal and its implications. It ends with six suggestions to water systems that include developing a service line material inventory and identifying funding strategies to accelerate full lead service line (LSL) replacement.

With this suggestion in mind, we are continuing our work evaluating state efforts to develop LSL inventories by taking a closer look at reporting by Wisconsin municipal and private water utilities[1] to the state Public Service Commission (PSC) for calendar year 2018.[2] Of the other states with mandatory inventory reporting, we have previously covered Illinois in detail and will evaluate Michigan’s newly released reports soon. The only other state with mandatory reporting is California, but it has limited value because it only covers the portion of the service line owned by the utility and excludes the portion on private property.

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Best practices for reducing cadmium in food: New review from FDA scientists

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

Note to readers: As we all grapple with the grave global health challenge from COVID19, we want to acknowledge the essential services that the professionals at the Food and Drug Administration and in the food production, processing and retail industries provide in continuing to deliver food. In the meantime, we are continuing to work towards improved health protections – including reducing chemicals in food. We’ll plan to keep sharing developments that may be useful to you. In the meantime, please stay safe and healthy.

Two years ago, the Food and Drug Administration (FDA) put cadmium on our radar when the Toxic Elements Working Group included cadmium together with arsenic, lead and mercury as metals affecting children’s neurological development. As part of that effort, FDA committed to look at all four metals across all foods instead of one contaminant, one food at a time. Last year, FDA’s scientists published a peer-reviewed article assessing children’s exposure to lead and cadmium in the diet. They found that spinach, lettuce, sunflower seeds, potato chips and wheat cereal were among the top 10 foods with the highest cadmium concentration.

New review of mitigation strategies

This year, FDA’s scientists published in a peer-reviewed journal a review of mitigation strategies to reduce dietary exposure to cadmium. Because plants uptake cadmium from the soil and “70 to 80% of dietary cadmium intake in humans comes from plant-based food,” the article focuses on methods to “reduce or prevent initial uptake by plants.” The authors explained that cadmium enters the food supply through natural and manmade sources, highlighting that cadmium often is a contaminant in phosphate fertilizers. Cadmium is also a contaminant in zinc used to galvanize steel.

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