Monthly Archives: April 2021

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 22, 2021

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.
Posted in FDA, Food, GRAS, Health policy, PFAS, Public health, Regulation / Tagged , , | Comments are closed

A closer look at FDA’s “Closer to Zero” plan to reduce for heavy metals in children’s food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 21, 2021

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

This month, the Food and Drug Administration (FDA) released its “Closer to Zero” action plan to reduce exposure to heavy metals in foods for babies and young children. The plan, released in response to a recent House of Representatives Committee on Oversight and Reform report and the introduction of the Baby Food Safety Act in both the House and the Senate, is a step forward since it commits the agency to specific actions and general deadlines for the first time. However, there is room for improvement, specifically the agency should:

  1. Explicitly consider the cumulative effect of heavy metals on neurodevelopment when setting limits.
  2. Move up deadlines for draft action levels for arsenic and cadmium;
  3. Be consistent in messaging that there is no safe level of lead in children’s blood;
  4. Define what “as low as possible” and “children’s food” means as soon as possible;
  5. Be transparent by posting testing data quickly; and
  6. Add milestones for compliance verification with action levels and preventive controls.

Read More »

Posted in FDA, Food, Lead, Public health / Tagged , , , , , | Comments are closed

Lead pipes are in the news – Here’s why that matters

By Sam Lovell / Published: April 19, 2021

Sam Lovell, Communications Manager. 

“How many of you know, when you send your child to school, the fountain they’re drinking out of is not fed by a lead pipe?”

That stark question was posed by President Biden in a briefing following the announcement of the American Jobs Plan. The President’s historic infrastructure package includes $45 billion to fully replace lead pipes across the country. This has caused a surge of attention nationally on the problem of lead pipes, as administration officials and members of Congress voice support of the plan and local media outlets report on the implications of the investment.

And this attention is well-placed: across the country, an estimated 9.2 million lead service lines still provide water to US homes – putting children at risk of lead exposure and permanent harm to their brain development. While this has been an issue for far too long, this recent momentum – with the inclusion of funding in the American Jobs Plan and in several bills moving in both the House of Representatives and the Senate – is a promising sign that action is near.

Read More »

Posted in Drinking water, Lead, Public health / Tagged , , , , | Authors: / Comments are closed

The damage done, Part 2: A post-mortem on the Trump EPA’s assault on TSCA’s new chemicals program

By Richard Denison / Published: April 9, 2021

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

Part 2 of a 2-part series (see Part 1 here)

Last week’s announcement by EPA about improvements it is making to EPA’s reviews of new chemicals under the Toxic Substances Control Act (TSCA) indicated it will begin by reversing two of the most damaging policy changes the Trump EPA made to the program:

Under the Trump EPA policies being reversed, at least 425 new chemicals were granted unfettered market access despite potential risks or insufficient information.

  • EPA will cease avoiding issuance of the binding orders TSCA requires to address potential risk or insufficient information:
    “EPA will stop issuing determinations of ‘not likely to present an unreasonable risk’ based on the existence of proposed SNURs [Significant New Use Rules]. Rather than excluding reasonably foreseen conditions of use from EPA’s review of a new substance by means of a SNUR, Congress anticipated that EPA would review all conditions of use when making determinations on new chemicals and, where appropriate, issue orders to address potential risks. Going forward, when EPA’s review leads to a conclusion that one or more uses may present an unreasonable risk, or when EPA lacks the information needed to make a safety finding, the agency will issue an order to address those potential risks.”
  • EPA will cease assuming workers are adequately protected from chemical exposures absent binding requirements on employers:
    “EPA now intends to ensure necessary protections for workers identified in its review of new chemicals through regulatory means. Where EPA identifies a potential unreasonable risk to workers that could be addressed with appropriate personal protective equipment (PPE) and hazard communication, EPA will no longer assume that workers are adequately protected under OSHA’s worker protection standards and updated Safety Data Sheets (SDS). Instead, EPA will identify the absence of worker safeguards as “reasonably foreseen” conditions of use, and mandate necessary protections through a TSCA section 5(e) order, as appropriate.”

If you want the details on what was wrong with these policies – legally, scientifically, and health-wise – see EDF’s comments submitted to the agency last year and a summary of them here.

It’s no accident that these two policies were prioritized for reversal.  As I discuss below, each had massive adverse impact on the rigor and outcome of EPA’s reviews of new chemicals.  The result was that the Trump EPA allowed many hundreds of new chemicals to enter commerce under no or insufficient conditions.  It did this by:  1) illegally restricting its review to only the intended uses of a new chemical selected by its maker, hence failing to follow TSCA’s mandate to identify and assess reasonably foreseen uses of the chemicals; and 2) dismissing significant risks to workers that its own reviews identified, despite TSCA’s heightened mandate to protect workers.  Read More »

Posted in Health policy, TSCA reform, Worker safety / Tagged , , , | Authors: / Comments are closed

The damage done, Part 1: A post-mortem on the Trump EPA’s assault on TSCA’s new chemicals program

By Richard Denison / Published: April 8, 2021

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

Part 1 of a 2-part series (see Part 2 here)

With last week’s announcement by EPA that it intends to reverse two of the most damaging policy changes the Trump EPA made to EPA’s reviews of new chemicals under the Toxic Substances Control Act (TSCA), there is hope that going forward EPA’s reviews will once again conform to TSCA’s requirements and better protect workers, consumers, the public and the environment.

Predictably, the chemical industry and its phalanx of law firms – who demanded and embraced the Trump EPA’s policy reversals – have been howling loudly, doing their best impressions of Chicken Little.  They predict huge backlogs and economic calamity of all sorts, including an end to American innovation, and their lawyers are already threatening legal action – a clever way to drum up business, no doubt.

The fact is that EPA spends scarce resources reviewing hundreds of new chemicals every year that their manufacturers are not serious about – and often not in any hurry about – commercializing.  And industry then uses any delays in those reviews to argue that the review process is too rigorous and demand that it be scaled back.

But facts are stubborn things.

In this first post I’ll look at a few reasons why the industry’s new round of fear-mongering is not based in fact.  And in a second post I’ll look at the decisions on new chemicals made under the Trump EPA to shed more light on the real reason why industry is upset:  It just may have lost the inside track that yielded such high dividends in the form of flawed approvals of hundreds of new chemicals.  Or, as one prominent industry attorney bluntly said recently in a related context, “the good days are over, quite frankly.”  Read More »

Posted in Health policy, Industry influence, TSCA reform / Tagged , , | Authors: / Comments are closed

At all costs: Failings of Trump EPA’s proposed TSCA fee rule

By Lindsay McCormick / Published: April 7, 2021

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 »

Posted in Health policy, Regulation, TSCA reform / Tagged , , | Comments are closed