EDF Health

Public deserves strong safety reviews for chemicals

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: August 25, 2022

Maria Doa, PhD, Senior Director, Chemicals Policy

Innovation may involve bringing a new chemical to market, but before the new chemical can be used or sold, the Toxic Substances Control Act (TSCA), the nation’s primary chemical safety law, directs EPA to conduct a safety assessment. Specifically, EPA must affirmatively determine whether a new chemical may present—or is not likely to present—an “unreasonable risk of injury to health or the environment”.

Unfortunately, the chemical industry often provides EPA with very little toxicity data for its chemicals. At the same time, it pressures the agency to conduct assessments quickly, claiming that the chemicals under review support innovation and should therefore be approved quickly.

EPA should never be pressured to rubber stamp a safety assessment, no matter how innovative a company claims its new chemical to be. The potential consequences of this pressure for us could include being exposed to chemicals in unanticipated ways and having to spend enormous sums to clean up our air, water, and land. Instead, EPA must be allowed to use the best available information and conduct robust TSCA reviews. Read More »

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Over 7 million children exceed FDA’s new daily maximum intake level of lead

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 24, 2022

Tom Neltner, Senior Director, Safer Chemicals

This is the fourth in our Unleaded Juice blog series exploring how the Food and Drug Administration (FDA) sets limits for toxic elements like lead, arsenic, and cadmium in food and the implications for the agency’s Closer To Zero program.

In June, after issuing its proposed action levels for lead in juice, FDA tightened its Interim Reference Levels (IRLs) for lead to 2.2 µg/day for children and 8.8 µg/day for females of childbearing age—a drop of 27% from the original IRLs it established in 2018. We estimate this change increased the number of children over the IRL for lead from 1.2 million to more than 7 million.

The agency describes IRLs as daily maximum intake levels for lead in food and beverages. FDA scientists said the change was made to match the Centers for Disease Control and Prevention’s (CDC) October 2021 revised blood lead reference value.  This value is commonly known as the elevated blood lead level (EBLL).[1] FDA uses the “interim” label in recognition that there is no known safe level of exposure to lead and the neurotoxic harm it can cause. FDA anticipates matching the IRLs to future reductions in CDC’s reference value as the U.S. makes progress in reducing children’s exposure to lead.

We applaud FDA’s decision to tighten the IRLs. It is a good example of the type of continuous improvement to which FDA committed in its Closer to Zero Action Plan, which aims to lower levels of lead, cadmium, mercury, and inorganic arsenic in food that babies and young children eat and drink.

The challenge now is to translate the tighter daily maximum intake level into action levels for specific foods. Next steps for FDA should include:

  • Further tightening its recently proposed action level for lead in juice.
  • Using the revised lead IRLs as:
    • The basis for its proposal for foods commonly consumed by babies and young children – currently stuck in the review process at the White House’s Office of Management and Budget (OMB).
    • A model for FDA’s anticipated IRLs for inorganic arsenic and cadmium under its Closer to Zero program.

Read More »

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Upcoming EDF Webinar: Register Now!

By EDF Blogs / Published: August 11, 2022

Cumulative Risk Assessment Framework: A Tool to Spur Improved TSCA Risk Evaluations

Wednesday, September 7, 2022

1:00–2:00 p.m. (ET)

Join the EDF Safer Chemicals team and our academic partners from the University of Maryland and the University of Rochester as we debut a new tool, the Cumulative Risk Assessment Framework, to support implementation of the Toxic Substances Control Act. The tool will encourage more robust evaluations of health risks from chemicals and other stressors—improving public health and increasing environmental safety.

This webinar will be of interest to those who conduct or study chemical risk evaluations/assessments, including scientists/researchers, policy makers, and policy implementers.

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Tara Flour: A Reminder of the Real-Life Consequences of Broken GRAS

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 10, 2022

Tom Neltner, Senior Director, Safer Chemicals and Maricel Maffini, EDF consultant

This blog is the fifth in our Broken GRAS series where we explore the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) system for novel chemicals added to food.

In the spring, folks who ordered from a company that sells pre-assembled smoothies and other frozen foods for home delivery, started getting sick—really sick—after consuming an item called “French Lentil and Leek Crumbles” (Crumbles). Daily Harvest, the manufacturer, recalled the product on June 17. A month later, Daily Harvest said it had ruled out various food-borne pathogens, mycotoxins, heavy metals, and major allergens and had “identified tara flour as the cause of the issue.”

By the end of July, FDA reported the product had been linked to 329 illnesses and 113 hospitalizations in 36 states—a surprising number for a product that sold only 28,000 items. Consumer Reports described the health effects as fever, fatigue, vomiting, diarrhea, and liver problems. At least 25 people who consumed the Crumbles required surgery to remove their gallbladders. Read More »

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Unleaded Juice: Getting Credible Lab Results is Essential

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 2, 2022

Tom Neltner, Senior Director, Safer Chemicals

This is the third in our Unleaded Juice blog series exploring how the Food and Drug Administration (FDA) sets limits for toxic elements like lead, arsenic, and cadmium in food and the implications for the agency’s Closer To Zero program.

FDA’s move to establish action levels on lead in juice – and eventually other foods that young children eat or drink – is an important step forward. While we believe that the action levels need to be tougher, any action level has a limited value if labs that analyze samples for contamination provide results that buyers, regulators, or consumers cannot trust.

We recommend that labs meet four criteria to provide credible results:

  • Be accredited under international standards for testing and calibration of labs (ISO/IEC 17025);
  • Use the analytical method based on FDA’s Method 4.7 [PDF, 1.16MB];
  • Demonstrate proficiency in a third-party, blinded test to quantify lead, arsenic, and cadmium to around 6 parts per billion (ppb); and
  • Provide a written report of results at that level.

Here is the list of labs that met these criteria as of August 2021. See below for our in-depth analysis.

Read More »

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EPA Takes Important Step to Ban Chrysotile Asbestos

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: July 20, 2022

Maria Doa, Ph.D., Senior Director, Chemicals Policy

EPA has made the important and long-awaited decision to propose banning nearly all remaining uses of chrysotile asbestos in the United States. EDF submitted comments supporting this proposed ban (with some caveats) because of the high risk of cancer and fatal respiratory diseases for individuals who import, process, distribute, and use chrysotile asbestos. The rule could be significantly improved by requiring a more immediate ban. If EPA chooses a more extended phase-in of the ban, we recommend that the Agency require companies to reduce workplace exposures in the interim to better protect workers.

Summary of Key EDF Concerns and Comments

Although asbestos is a known carcinogen, it is still used in automobile brake linings, gaskets, and brake blocks, as well as in permeable separators (diaphragms) at chlor-alkali facilities to produce chlorine and caustic soda. Currently, nearly 40,000 Americans die each year from asbestos-related illnesses. These deaths are preventable and must be stopped, and we applaud EPA for taking this step toward doing so.

  • EDF supports rapid implementation of EPA’s proposed chrysotile asbestos ban. Given the unreasonable risk posed by asbestos, we call on EPA to start the ban for all uses within 6 months after publishing the finalized rule.
  • In the event EPA chooses an extended phase-in (>6 months) of the ban on using chrysotile asbestos in chlor-alkali diaphragms and sheet gaskets, it should require companies to reduce workplace exposures during the interim in a way that poses the least risk to potentially exposed populations—particularly workers. In this case, we call on EPA to require hazard communication and the hierarchy of controls—first by reducing exposure through process, engineering, or administrative changes. Personal protective equipment (PPE) as a risk-reduction measure should be used only after applying these other controls to reduce chemical exposures. However, this approach would be less effective and more burdensome on workers than eliminating exposure completely and should be used only as a short-term, interim measure until the ban goes into effect.
  • EPA should explain how its proposed disposal requirements address the unreasonable risk presented by chrysotile asbestos. EDF is concerned that EPA has not demonstrated how compliance with OSHA’s Asbestos General Industry Standard and EPA’s National Emission Standards for Hazardous Air Pollutants would eliminate unreasonable risk, as TSCA requires.
  • EPA underestimates the benefits of preventing health impacts by banning chrysotile asbestos. In baseline exposure calculations, the Agency inappropriately assumes that workers will consistently and correctly use PPE while handling chrysotile asbestos and dramatically underestimates how many individuals will benefit from the rule. EPA should bolster its Economic Analysis in the final rule to more accurately reflect the benefits of the ban.

In addition, the proposed rule indicates EPA is continuing to include troubling policy decisions in its risk evaluations. Moving forward:

  • EPA should not consider costs or other non-risk factors in risk evaluations. EPA states it will consider use of PPE and other risk-management activities in its risk evaluations to help in making risk-management decisions—an approach that is not scientifically supportable and inappropriately conflates risk assessment with risk management.
  • EPA should not inappropriately treat workers differently from the general population by applying a less-protective cancer benchmark for workers. TSCA does not support this approach. Given that workers are particularly identified in TSCA for consideration and often face higher risks than the general population, making a less-protective standard is especially unjustified. (See our June 21, 2022 blog post on this issue.)

EDF also found many areas of agreement with EPA in the proposed risk-management rule. You can read the full set of comments here.

 

 

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