EDF Health

Upcoming EDF Webinar: Register Now!

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.

Registration is required.

 

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

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

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

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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FDA decisions leave ortho-phthalates in food and our safety in limbo

Tom Neltner, Senior Director, Safer Chemicals; Maricel Maffini, Ph.D., Consultant

On May 19, the Food and Drug Administration (FDA) announced four incongruous actions in response to petitions submitted by EDF and others asking the agency to ban the use of more than two dozen ortho-phthalates (phthalates) in food packaging and processing equipment. We filed the petitions because we were concerned that these hormone-disrupting chemicals were harming people, especially children, who consume food contaminated by this class of chemicals. Since filing the petitions six years ago, the evidence of harm – and our concern for children’s health – have only grown more compelling.

Despite a statutory duty to decide whether the authorized uses were safe, the agency delayed making a decision and then essentially dodged the safety issue, opting instead to allow nine phthalates it had approved decades ago to be used in plastics, paper, and adhesives that contact food or drinks. FDA only acted in response to a lawsuit filed by Earthjustice for EDF and other health and environmental advocates.

FDA’s decisions allow phthalates to continue to seep into our food and do little to protect the public. As a result, EDF and the other advocates, supported by Earthjustice, filed formal objections to the agency’s decisions on two food additive petitions and petitioned the agency to reconsider its denial of a separate citizen petition. We also demanded an evidentiary public hearing to consider the significant new evidence FDA glossed over. Read More »

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Workers are people too; EPA should treat them that way

EPA’s proposed TSCA rule to limit risks from chrysotile asbestos uses a higher “acceptable” cancer risk for workers than the rest of the population

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

When it comes to drawing the line on cancer risks, should workers be treated differently than the general population? Of course not. Unfortunately, EPA’s recently proposed rule to manage risks from chrysotile asbestos does just that, using one level of acceptable risk for workers and another – more protective threshold – for everyone else.

EPA says it uses a range for determining acceptable cancer risks under the Toxic Substances Control Act (TSCA), the country’s main chemical safety law. The range spans a risk (or the chance that a person will develop cancer) of less than one in 10,000 to a risk of less than one in one million. EPA says this is consistent with the cancer benchmark used by the National Institute for Occupational Safety and Health (NIOSH).

However, EPA’s proposed TSCA rule for asbestos does not actually use a range and it is not supported by TSCA. EPA instead applies a risk level to workers 100 times less protective than for everyone else! Read More »

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