EDF Health

10 ways the incoming FDA Commissioner should protect people from toxic chemicals in food

Tom Neltner, Chemicals Policy Director.

The FDA’s critical role in the COVID-19 pandemic has brought intense interest in whom President Biden will nominate to lead the agency as its new commissioner.

While COVID-19 is the priority, the FDA obviously has many vital other responsibilities. Though it doesn’t get that much attention, one of the important roles of the agency is to protect the public from unsafe chemicals in food. Frankly, their record has been disappointing, but the new administration has an opportunity to fix some key problems that scientists and doctors have been warning us about for years.

Here are ten things the new FDA Commissioner should do to keep unsafe chemicals out of our food. The list ranges from actions on specific chemicals to broader reforms.

  1. Stop letting industry decide for themselves, in secret, whether chemicals are safe and can be added to food. EDF, represented by Earthjustice, and the Center for Food Safety, have sued the agency to close the dangerous “Generally Recognized as Safe” loophole.
  2. Systematically reassess dangerous food chemicals it has allowed to be used in food based on new information. The FDA approved the use of many chemicals in food decades ago, and we now have evidence that some of these are unsafe. A chemical shouldn’t be given a forever approval. There needs to be a systematic process to review the scientific evidence, especially when new risks come to light.
  3. Ban the use of perchlorate, an ingredient in rocket fuel, from use in plastic packaging and equipment that comes into contact with food. Perchlorate gets into food, and exposure is particularly dangerous for pregnant women, infants, and young children, as it has been linked to developmental delays, reduced growth, and impaired learning abilities. We’ve sued the FDA to get this chemical out of food, and the case is pending.
  4. Comply with its 60-year-old Congressional mandate to look at the cumulative effect of chemical exposures people have when deciding whether to approve the use of related chemicals in food. EDF’s investigation of 900 approval decisions found that just one followed this common-sense mandate. The reality is that no one is exposed to just one chemical – so the agency shouldn’t be analyzing chemicals’ safety as if that were the case. FDA must respond to a petition filed by EDF and other organizations demanding that the agency follow the law and assess chemicals as classes.
  5. Drive down levels of heavy metals in food. Over the last decades, evidence has emerged of concerning levels of lead, arsenic, and cadmium in food consumed by children, such as rice, juice, and root crops like sweet potatoes and carrots. The FDA should move quickly and aggressively on its new commitment to set limits on heavy metals in food children eat and should also set limits for other food.
  6. Use modern science when evaluating if a chemical poses a health risk. The FDA is stuck in the past by relying on outdated, less accurate scientific methods and ignoring the evolving information we now know about chemical exposure. You wouldn’t insist on driving a car the Flintstones drove just because that was the first car ever.
  7. Prohibit lead from being added to materials that contact food, such as the tin that lines metal cans, and tighten limits for lead in bottled water. EDF’s analysis of FDA data found lead in 98% of certain canned fruits compared to 3% in fresh or frozen types. We’ve sent a formal petition to FDA requesting it immediately take action to ban these harmful and unnecessary uses of lead. Though it’s not a food safety issue, the FDA should also reject a challenge to its decision to ban lead acetate in hair dye. That challenge has put the FDA decision on hold, meaning that people are literally still putting lead on their head!
  8. Prohibit ortho-phthalates from being added to food packaging and processing equipment. These chemicals are known to disrupt hormones and harm brain development. The FDA is significantly overdue in meeting its legally required deadline to make a decision based on a petition from 2016 by EDF and nine other consumer, public health, and environmental groups to ban these chemicals.
  9. Be more transparent about the decisions it is making on chemicals in food. Information about FDA decisions should be publicly available without a Freedom of Information Act request and a months-long wait to learn more about agency actions on the chemicals in our food supply.
  10. Take aggressive action on harmful PFAS in food packaging and processing equipment. PFAS (Per- and poly-fluorinated alkyl substances) can provide water and grease resistance to paper and paperboard and can also leach into food. Growing evidence links PFAS to a wide range of serious health effects – from developmental problems to cancer. And now we know that many types of PFAS bioaccumulate in the body.
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At all costs: Failings of Trump EPA’s proposed TSCA fee rule

Lindsay McCormick, Program Manager and Richard Denison, Ph.D., Lead Senior Scientist

When Congress reformed the Toxic Substances Control Act (TSCA) in 2016, it authorized EPA to require companies to pay fees to help defray the agency’s costs of administering this extensive new law.  EPA finalized the first “fee rule” in 2018 to establish the payment framework.  Under TSCA, EPA is to adjust the fees every three years both to account for inflation and to ensure it is recouping the authorized portion of agency costs to implement the law.

Therefore, developing an accurate estimate of the agency’s costs to implement TSCA is critical.  Not only does this provide the baseline by which to establish industry fees (as EPA is to set the fees so as to recoup 25% of its program costs), but it should serve as a north star to identify the true resource needs to lawfully implement TSCA.

Recent reports by the Government Accountability Office and EPA’s Office of Inspector General found that EPA’s ability to assess and manage chemicals regressed over recent years due to lack of workforce or workload planning to ensure the agency can carry out its duties.  Both reports recognize the greatly increased scope of work under amended TSCA, and EPA’s failure to translate that into additional staff and resource needs.  Establishing a robust, accurate budget for administering TSCA is the first step to rectifying this problem.

Despite the alarm bells rung by these two watchdogs, the Trump EPA’s proposed revised fee rule seems to have lost sight of Congress’ purpose in expanding EPA’s fee authority.  The proposed rule invokes a new purpose entirely divorced from TSCA: to reduce asserted burdens on industry – without regard to the impacts that will have on EPA’s ability to implement the law or on ensuring health and environmental protection from chemical exposures.  As a result, EPA underestimated its costs and proposed fees such that, if finalized, would push an undue portion of its costs onto the taxpayer.

Below we summarize the major concerns about the fee rule proposal that we detailed in our comments submitted to the agency late last month. Read More »

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EPA’s three new service line notices: Critical to transparency and accelerating lead pipe replacement

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

This is the second in a series of blogs evaluating various aspects of EPA’s December 2020 revisions to the Lead and Copper Rule (LCR) and what they may mean for accelerating lead service line (LSL) replacements. The blogs cover: 1) new service line inventory; 2) three new LSL notices; 3) environmental justice implications; 4) communicating health effects of lead; 5) economic implications; and 6) sampling and trigger/action level.

Note that President Biden’s Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis directs agencies to review the former administration’s regulations and actions, including the Lead and Copper Rule. 

Three new notices required by the revised LCR from water systems to people with known or potential LSLs provide critical opportunities to build public support for LSL replacement by helping individuals better understand their situation and specific actions they should take. However, we recognize that, like all notices, many people may simply ignore them, especially if only delivered as an insert to a monthly or quarterly bill. We anticipate that notices will be most effective when coupled with broader outreach efforts and requirements that property owners share the notice with potential buyers and tenants.

As explained in a previous blog on the new service line inventories, water systems must assign all service lines to one of four categories. The rule treats three categories – “Lead,” “Galvanized Requiring Replacement,” and “Lead Status Unknown” – as known or potential service lines containing lead. People receiving water from a service line in any of these three categories must receive three new types of notices designed to prompt them to take steps to address the risk of lead in their drinking water pursuant to 40 CFR § 141.85(e) to (g). The three types of notices are:

  1. An annual notice;
  2. A notice of disturbance to service line; and
  3. A notice if trigger or action levels exceeded.

Read More »

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EPA’s new service line inventory: The good, the bad, and the absurd

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

This is the first in a series of blogs evaluating various aspects of EPA’s December 2020 revisions to the Lead and Copper Rule (LCR) and what they may mean for accelerating lead service line (LSL) replacements. The blogs cover: 1) the new service line inventory; 2) three new LSL notices; 3) environmental justice implications; 4) communicating health effects of lead; 5) economic implications; and 6) sampling and trigger/action level. 

Note that President Biden’s Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis directs agencies to review the former administration’s regulations and actions, including the Lead and Copper Rule. 

The backbone of the revised LCR is a new service line inventory[1] that all public water systems, whether large or small, rural or urban, must develop by January 2024 unless they can demonstrate that they have no LSLs. If properly designed and implemented, the inventory should transform how utilities, communities and states approach LSLs by moving from rough estimates to a data-driven approach that allows water systems to identify what is known and not known about the service lines, communicate that information to the public, and establish LSL replacement priorities.

Unfortunately, EPA has included an unfortunate and absurd new detail in the inventory that requires systems to categorize service lines that contain a two-foot piece of lead pipe, often known as a gooseneck, as “Non-lead.” We anticipate that the absurdity of calling a lead pipe “Non-lead” will undermine the inventory’s credibility and effectiveness.

What is the new service line inventory and how is it used?

By January 2024, water systems must submit a service line inventory to the state and make it publicly accessible pursuant to 40 CFR § 141.84(a). To develop the inventory, they must assign all service lines, regardless of ownership, for the portions on public or private property to one of four categories:

  1. Lead: where a portion of the service line is made of lead (excluding lead connectors, such as goosenecks, as explained below). We presume this includes lead-lined pipe.
  2. Galvanized Requiring Replacement: where a portion of the service line is galvanized iron or steel.[2] If the system can determine that the galvanized pipe was never downstream of an LSL (or lead connector, such as a gooseneck[3]), then it is essentially a galvanized pipe not requiring replacement and can be categorized as “Non-lead.”
  3. Non-lead: where the line is determined not to be “Lead” or “Galvanized Requiring Replacement” (see discussion below for lead connectors). Our understanding is that systems could assume service lines installed after the 1986 federal ban on lead pipe are “Non-Lead.”
  4. Lead Status Unknown: where it has not been determined if the service line met the SDWA Section 1417 definition of “Lead-free” at 42 U.S.C. § 300g-6. We presume this means that solder or flux must be less than 0.2% lead and other wetted surfaces must be less than 8% from 1986 to 2013 and less than 0.25% for 2014 to present.[4]

Under these requirements, a service line is classified as an LSL if it is in the “Lead” or “Galvanized Requiring Replacement” categories.[5]

Read More »

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EDF statement: Trump EPA’s withdrawal of proposed bans on dangerous uses of three chemicals is shameful

Decision epitomizes administration’s disdain for public health protection

(Washington, DC – January 14, 2021) Tomorrow, the Trump EPA will announce the formal withdrawal of proposed bans on high-risk uses of the dangerous chemicals methylene chloride, trichloroethylene, and N-methylpyrrolidone. By taking this action, the Trump EPA seeks to prevent the new administration from finalizing any of these bans without starting the process over.

“It appears that blocking these bans and denying crucial protections to workers and consumers for four years was not enough for the Trump EPA. This shameful move that epitomizes the Trump EPA’s concerted attacks on public health is a transparent attempt to further constrain the incoming administration. It is yet another stain on Mr. Wheeler’s dismal record,” said Dr. Richard Denison, Lead Senior Scientist, EDF Health. “We are counting down the days until the EPA’s decisions, once again, reflect its mission to protect health and the environment.”

Background:

Read More »

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Haste makes waste: The Trump EPA’s 1,4-dioxane supplement may be its shoddiest TSCA work yet

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

Yesterday EDF submitted comments on a supplement to EPA’s 1,4-dioxane risk evaluation under the Toxic Substances Control Act (TSCA), which the agency issued a scant three weeks ago.

This solvent is a likely human carcinogen that contaminates drinking water nationwide and is present in millions of consumer products.[pullquote]What EPA left out of its analysis swallows what it included.[/pullquote]

The supplement expands the scope of EPA’s ongoing risk evaluation of 1,4-dioxane.  It now includes certain water exposures and certain exposures of consumers to products in which the chemical is present as a contaminant (more technically, a “byproduct”).

EPA rushed the public comment period, providing only 20 days and refusing requests from at least 14 organizations for an extension.  The agency also cut out another vital step in the process – peer review –in violation of its own rules for how risk evaluations are to be conducted.

But that wasn’t the only thing EPA rushed.  The Supplement itself was an 11th-hour affair, done mainly to appease a hypocritical demand from the formulated chemical products industry.

The haste with which it was assembled badly shows.  The additional exposures EPA examined are so narrowly constructed as to omit major, and potentially the largest, sources of exposure and risk people face from the presence of 1,4-dioxane in water and products.

And what EPA left out of its analysis swallows what it included.  Read More »

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