EDF Health

FDA’s squishy definition of adverse health effects of substances in food

By Maricel Maffini, PhD, Consultant and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 15, 2023

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

3 human figures showing stages of becoming ill. First figure is all white and standing up straight. Second figure is bent over and stomach area is red. Third figure is is all red, bent over, and appears to be vomiting.

What Happened

A recent peer-reviewed publication criticized FDA’s criteria for identifying adverse health effects associated with exposure to pathogens, chemicals, or allergens in foods. The authors gave two recent examples of the agency dismissing health concerns: a toxin created in spoiled fish that caused temporary, medically adverse health effects because they were short-term and reversible, and an additive where evidence from animal testing showed harm in only one sex. The authors concluded that the agency’s criteria are “inadequate because they are not science-based.”

Why It Matters

FDA is responsible for protecting food safety and the public’s health. In order to do that, it makes decisions whether a pathogen, chemical, or allergen causes an adverse health effect that must be avoided—so the agency’s definition of an adverse health effect is critically important. Unfortunately, FDA lacks a clear definition of the term, usually approaching it on a case-by-case basis in a manner that lacks transparency and scientific grounding.

Adverse Effects Dismissed by FDA

In 2020, the director of The Pew Charitable Trusts’ food safety project argued that FDA failed to “protect Americans from preventable illnesses” because it considered that the effects caused by the fish toxin were temporary or reversible. FDA described the toxin’s effects, which ranged from facial flushing and sweating, dizziness, nausea and headache to more severe cases of blurred vision, respiratory stress, and swelling of the tongue. The Pew director reasonably added that people may require hospitalization, medical treatment due to cardiac complications, and altered blood pressure–all of which are adverse health effects.

In a 2019 final rule approving the listing of leghemoglobin as a color additive, the Center for Food Safety objected that FDA dismissed statistically significant “changes in blood chemistry, blood clotting ability, and blood globulin values” as potential health effects. In its response to the objection, the agency argued that “statistical differences seen between control animals and treatment animals due to small changes in the value of the parameter are not likely to be of biological or toxicological significance.” FDA further stated that for the color additive to cause the blood changes to be “potentially adverse” it should:

  • Show a “clear dose-response,” described as a direct relationship between the dose given and the effect observed, in other words, the higher the dose, the higher the effect; and
  • Be observed in both sexes of the species in which the substance is tested.

This argument put forth by FDA’s food safety scientists would be summarily dismissed by their colleagues on the drug side because it ignores current scientific principles: dose responses can have different shapes and there are known sex differences in response to exposures from multiple chemicals.

Our Take

This is an ongoing issue. Other organizations have defined “adverse health effects.” For example, EPA’s Integrated Risk Information System (IRIS) defines adverse effect as “[a] biochemical change, functional impairment, or pathologic lesion that affects the performance of the whole organism, or reduces an organism’s ability to respond to an additional environmental challenge.”

FDA’s lack of a practical definition for adverse health effect and how the agency applies it in food safety assessments has likely contributed to inconsistencies in its decision making.

Next Steps

We will continue to press the agency for transparency about what health effects it considers important to prevent and protect the health of American families. FDA should publish clear, rational, science-based criteria for determining adverse effects and periodically review them as our knowledge base advances to better inform regulatory decisions.

Also posted in Adverse health effects, FDA, Health hazards, Health policy, Public health, Regulation / Tagged , , , | Authors: , / Comments are closed

Representatives Call For FDA Public Hearing on Phthalates

By Joanna Slaney and Maricel Maffini, PhD, Consultant / Published: June 6, 2023

By. Joanna Slaney, Senior Director, Federal Affairs, and Maricel Maffini, PhD, Consultant

U.S. Capitol dome framed by trees

Source: A. Paige Baker, ShutterSights.com©

What Happened?

On May 19, Reps. Katie Porter, Steve Cohen, Nanette Diaz Barragán, Earl Blumenauer, and Raúl Grijalva issued a letter [PDF, 300KB] to FDA Commissioner Robert Califf calling on FDA to “act expeditiously to protect the public from the health risks posed by phthalates in food and food packaging.”

They asked the FDA to hold a public hearing on ortho-phthalates (phthalates), chemicals associated with disruptions to the development of the male reproductive system and neurodevelopment, among other health effects.

Why It Matters

In 2021, Reps. Porter and Lieu led a letter with 12 colleagues urging FDA to take action on phthalates in food and cosmetics. That letter, in part, called on FDA to take action on a 2016 petition filed by EDF and allied environmental health organizations asking FDA to revoke its approval for all uses of phthalates in food packaging and processing equipment.

In May 2022, after the petitioners sued, FDA denied the petition. The petitioners formally objected to the decision and requested a public hearing pursuant to FDA’s regulations. The agency has not provided any timeline for acting on the objections.

Request for a Public Hearing

The Representatives stated in the letter submitted last month that  FDA’s decision denying the petition was flawed. “[W]e are deeply concerned about the denial, which was made without deciding whether the remaining approved uses of phthalates in food and food packaging are safe.” (Emphasis original)

They reminded Commissioner Califf of his recent statement that chemical safety is a “really, really important area for the future – for humankind, really – and where science is evolving rapidly,” urging FDA to hold a public hearing on two areas of concern:

  • The agency’s failure to evaluate the safety of phthalates as it was legally required to do before denying the 2016 petition. The letter stated, “failing to evaluate the safety of phthalates is an abdication of the FDA’s continuing obligation to oversee the safety of the food supply.”
  • FDA’s failure to address new toxicity information that raises significant questions about the safety of phthalates. Phthalates are associated with numerous health issues, including reproductive and developmental toxicity, endocrine disruption, immune toxicity, and epigenetic alterations. The letter stated, “the denial of the petition fails to acknowledge, let alone analyze, the dozens of peer-reviewed studies that underscore the toxicity of the phthalates that remain approved for food contact use.”

Next Steps

EDF and our allies will continue to press FDA to hold a public hearing on the safety of phthalates used in food packaging and processing equipment.

Go Deeper

EDF blogs on phthalates

Also posted in Congress, Developmental toxicity, Endocrine disruptors, FDA, Food, Food packaging, Phthalates, Public health, Public hearing, Regulation, Reproductive toxicity / Tagged , , , , , | Authors: , / Comments are closed

European Food Safety Authority reaffirms that BPA uses for food are not safe. Where is FDA?

By Tom Neltner, Senior Director, Safer Chemicals Initiative and Maricel Maffini, PhD, Consultant / Published: April 19, 2023

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

Warning message written in bold red letters with words Bisphenol A Exposure. 3d illustration.

What Happened?

Today, the European Food Safety Authority (EFSA) finalized its Re-evaluation of the Risks to Public Health Related to the Presence of Bisphenol A (BPA) in Foodstuffs report. After considering public comments on its November 2021 draft, the agency reaffirmed its conclusion that Europeans of all ages are exposed to BPA at levels 100 to 1,000 times greater than EFSA considers to be safe.

Why It Matters

EFSA found that consumers’ dietary exposure should be less than 0.2 nanograms of BPA per kilogram of body weight per day (ng/kg-bw/day) to protect their immune systems from harm.1 Although EFSA didn’t analyze the reality for U.S. consumers, we used FDA’s 2014 estimated dietary exposure for BPA (the most recent available) to calculate that Americans’ exposure is 1,000 times greater than what EFSA deems safe.

Our Take

EFSA’s analysis is primarily based on scientific evidence that FDA had not considered in previous reviews. With the final report in place, EFSA has completed a rigorous, transparent, and comprehensive risk assessment. FDA now has no excuse for delaying action on a food additive petition submitted by EDF and our partners that the agency agreed to consider on May 2, 2022. That petition requested that FDA revoke its approvals for using BPA in adhesives and can coatings and set strict limits on using it in plastic that contacts food. FDA has not yet responded.

EFSA’s Conclusions

EFSA found that extremely low exposures to BPA can lead to an overactive immune system producing out-of-control inflammation. BPA was also associated with disrupting the endocrine system, harming reproduction, and reducing learning and memory. The immune system was most sensitive to BPA exposure.

After calculating a safe level of BPA—known as TDI (tolerable daily intake)—that would prevent anticipated harm, EFSA compared it against the estimated dietary exposure of the European population. The agency concluded that “both the mean and the 95th percentile dietary exposures in all age groups exceeded the TDI by two to three orders of magnitude.”

Putting BPA New Safe Level in Context

EFSA’s safe dose of 0.2 ng/kg-bw/day is extremely low. It may be useful to compare it to exposure from drinking water. For an adult weighing 120-pounds who drinks 2 liters of water a day, it would take only 1.2 parts per trillion of BPA to exceed the safe level.2

Next Steps

We will press FDA to act with greater urgency on our overdue petition. We are also looking at whether there is increased risk to communities near where BPA is made or processed.

NOTES

1 The limit was 0.04 ng/kg-bw/day in the draft EFSA report.

2 0.2 ng/kg-bw/day * 60 kg / 2 liters = 1.2 ng/L = 1.2 ppt. This does not account for other sources of BPA in the diet.

 

 

Also posted in BPA, EFSA, Emerging science, Emerging testing methods, Environment, FDA, Public health / Tagged , , , | Authors: , / Comments are closed

National Teflon Day—Seriously?!

By Lauren Ellis / Published: April 7, 2023

What’s National Teflon Day?

According to National Day Calendar, yesterday (April 6th) was “National Teflon Day”—a day to “celebrate” the accidental discovery in 1938 of a chemical called polytetrafluoroethylene (PTFE for short)—better known by the product it became associated with, Teflon™.

Two 3D emoji rolling their eyes.

Teflon™ is PFAS Wrapped in a Bow

PTFE, the main component of Teflon™, is a fluorinated polymer that belongs to the PFAS chemical class—aka “forever chemicals.” PTFE is extremely heat- and stick-resistant—properties that lend themselves to a variety of uses, ranging from nonstick pans to semiconductors.

While some argue that PTFE itself does not present a health risk when used properly, the harms of PTFE become clear when you look across the chemical’s lifecycle—particularly the ways it’s produced and how it’s disposed of.

The Harms of PTFE Production

Harmful PFAS are used to produce PTFE and are also byproducts of the production process—exposing workers and surrounding communities.

PFOA—a notoriously toxic PFAS linked to cancer and heart disease—was used to manufacture PTFE for decades. In response to public pressure to phase out PFOA due to its harms, companies created other PFAS to replace PFOA—such as GenX, which has similar health effects as its predecessor. In addition to these harmful inputs, toxic PFAS byproducts are also created and released during the manufacturing of PTFE.

Decades of manufacturing PTFE have led to widespread PFAS contamination of our environment and our bodies.

The Harms of PTFE Disposal

At the end of the chemical lifecycle, fluoropolymers like PTFE may end up in a landfill—say, when you throw away your old Teflon™ pan. Over time, particles begin to disintegrate, leading to contamination of landfill liquids with PFAS that can then make their way into soil and drinking water.

Waste containing PTFE may also be incinerated. Burning of any type of PFAS is known to generate many other harmful PFAS—including potent greenhouse gases, such as tetrafluoromethane (which has a warming potential 6,500 times that of carbon dioxide).

Next Steps

Given the public health and climate effects of PTFE throughout its lifecycle, the next steps are clear: 1) Stop producing PTFE and other fluoropolymers for uses where there are clear alternatives; and 2) Stop celebrating the discovery of Teflon™ and the explosion of PFAS products (and pollution) that followed.

Also posted in Environment, Public health / Authors: / Comments are closed

Health data needs to inform targeted environmental justice initiatives

By Ananya Roy and Veronica Southerland / Published: April 4, 2023

Key Findings and Recommendations 

  • Air pollution results in a large burden of childhood asthma across the country, and this burden is disproportionately borne by people of color.
  • More than $100 million in grants from the Environmental Protection Agency is available for environmental justice initiatives, but targeting programs to alleviate the health impacts of air pollution to overburdened communities requires local-level health information that is often not readily available.  
  • We recommend health advocates and researchers work with local and state public health departments and impacted communities to access existing fine-scale data where available.

In the past, the lack of neighborhood-scale data on baseline disease rates, pollutant concentrations and children’s asthma has made it difficult to determine which U.S. communities bear the highest health burden from air pollution. Disparities in pollution exposures have been routinely underestimated. Generating more fine-scale data, together with advances in hyperlocal air monitoring, will make visible the disparities in exposure to air pollution across and within neighborhoods, allowing us to target mitigation and prevention efforts for maximum benefit. 

We now have an opportunity to make significant progress towards identifying, prioritizing and addressing the harms faced by the most burdened communities. EPA has made available over $100 million dollars for grants to advance environmental justice, including health impact assessments. Grant recipients can use the funds to obtain health information at the neighborhood level, data essential for identifying communities with the highest burden of air pollution health impacts. The application deadline is April 14, 2023. 

Pollution and racism 

Using new air monitoring techniques, advances in modeling, and community-based participatory research, studies confirm that neighborhoods which have experienced historical racism also experience higher levels of air pollution.

Decades of discriminatory and racist policies, practices and disenfranchisement have resulted in the disproportionate exposure to pollution sources in communities of color, along with disinvestment in housing and economic opportunities in these communities. Communities of color and areas of low wealth therefore face exposure to higher levels of air pollution and are more vulnerable to that air pollution, resulting in heavier health burdens borne by families.  

Air pollution data is only half of the story 

While air pollutant exposure is important in determining the effect of that pollutant on the health of a community, social factors and existing disease burden and risk play a large role in the impact that pollutant will have on the total health burden attributable to a pollutant in a community.  

Existing disease burdens and risks in populations are reflected in “baseline disease rates,” a key public health metric documented by public health agencies. Baseline disease rates vary within cities, but those rates are rarely made publicly available for use in risk assessment. 

Gaps in baseline disease data availability limit the ability of health impact assessments to determine which communities have existing vulnerabilities to the harmful effects of air pollution. For example, while studies of pediatric asthma attributable to nitrogen dioxide, a traffic-related air pollutant, have estimated there are 200,000 affected children living in American cities, these studies have relied on national-level estimates of asthma incidence. These national-level estimates hinder the ability of researchers to determine which areas within cities are experiencing the highest burden of asthma attributable to asthma. 

Local-level health data is needed to identify risks to overburdened communities  

The public health information available from city to city and within cities is a mix of fine-scale data (ZIP code level) and coarse-scale data (ZIP3 – aggregated data based on ZIP code information, roughly the size of counties.) The assessment of health risks, factors and outcomes can vary greatly depending on which level of data is used. 

Studies have repeatedly shown that using fine-scale baseline disease rates can make a profound difference when mapping the spatial distribution of health burdens attributable to air pollutants and on the ability to quantify disproportionate impacts in disadvantaged populations. For example, in an analysis of within-city air pollution risks in the San Francisco Bay Area of California, we found the highest census block group baseline mortality rate was 12 times higher than the rates in the census block group with the lowest rates, while the highest county rate was only four times greater than the lowest county mortality rate.

Lack of fine scale data leads to unreliable analysis 

Our work in New Jersey highlights the pitfalls of using only coarsely-resolved spatial data in identifying those communities that are at highest risk of the health burdens of air pollution. An analysis of the impact of pollution in that state found that 18,000 asthma emergency room visits by children could be attributed to fine particle pollution and 70% of those impacts were among communities of color (Asian, Black and Native American) and Hispanic populations.

Comparing the results using coarse-scale and fine-scale data, we found that:

  • Analysis using coarse-resolution emergency room visit information overestimated the burden to white populations. It underestimated the burden to people of color by as much as 90%. 
  • Using fine-scale data, we found emergency room visits for the ZIP code with the highest burden to be 1.5 times higher than the highest burden estimated using coarse-resolution data. 
  • We also found that using fine-scale data revealed double the variation between the ZIP code with the highest risk of PM-attributable visits and ZIP codes with the least risk of PM-attributable visits. Variation allows us to observe the relative disparities in risk within a community that are not otherwise observable with coarse-scale baseline disease data. 

The use of coarse-resolution (ZIP3) asthma emergency department visit data may underestimate PM-attributable asthma burdens (number of cases per 10,000) among non-white populations when compared to fine-scale (ZIP) data. Red shows communities where coarse-resolution health data underestimates risks.

Local-level health information can help EPA and other funders to identify and direct resources to the communities that need it most, which are too often communities of color facing legacy injustices. 

Our work in the Bay Area of California highlights the need for fine-resolution data on baseline disease rates, as pollutant concentrations alone were unable to capture the variation of air pollution health risks within Oakland.  

The maps shown in Figure 2 are of the neighborhoods of West Oakland. Looking only at the spatial distribution of the highest pollutant concentrations (A), the area of highest risk appears to be the truck traffic corridor of I-880. However, when we incorporated census block group baseline disease rates (B), provided by the Alameda County Public Health Department, we found that the area of highest risk, and therefore where the largest emission reductions could result in the largest reduction in health burden, was another area of West Oakland where both baseline mortality rates and pollution levels were elevated.  

Pollutant concentrations and county baseline disease rates alone would not have revealed this vulnerable neighborhood. A better understanding of pollution hotspots can help direct federal funds intended to address long legacies of pollution burdens to communities where they’re most needed. 

West and Downtown Oakland. The map on the left (A) shows the spatial distribution of pollutant concentrations, with high concentrations highlighted in the blue circle near major roadways. The map on the right (B) shows the spatial distribution of air pollutant attributable health burdens when the spatial distribution of underlying disease patterns are taken into consideration. The area of highest air pollutant attributable health burdens in map (B) is highlighted in the blue circle.

Ways to expand and improve local-level health data 

Past investment in satellite-derived estimates and local air pollution monitoring has resulted in making exposure disparities visible. Similar investment is required now for developing fine-scale data on baseline disease rates, which will enable identification of communities with the highest air pollution-attributable health burdens.  

Mechanisms currently exist for developing more fine-resolution data on baseline asthma emergency department visits. As part of the analysis in New Jersey described above, we purchased discharge-level emergency department visit data for New Jersey from 2016 to 2019 from the Healthcare Cost and Utilization Project’s State Emergency Department Database (HCUP SEDD). We urge the Agency for Healthcare Research and Quality, which manages the HCUP SEDD, to develop baseline asthma emergency department visit datasets and that the Agency update these datasets annually and make them publicly available. 

We recommend that health advocates and researchers work with local and state public health departments to access existing fine-scale data where available. We have found that local health departments often have the data needed but lack the resources to dedicate staff and expertise to process and analyze the information. As an example, EDF has had success working with the Alameda County Public Health Department to develop mortality rates at the census block group level. Other impediments to developing baseline disease rates include lack of funding and concerns about privacy. 

Deadlines approaching for funding opportunities to develop local-level health data 

EPA is accepting environmental justice grant applications through April 14, 2023 through two avenues: the EJ Collaborative Problem-Solving Cooperative Agreement Program (EJCPS) and the Environmental Justice Government-to-Government (EJG2G) program. 

While both grant programs are relevant to the use of local-level health data, the Government-to-Government grants allow community-based organizations to partner with their local health department on use of local-level data in health impact assessments. This can help alleviate the problem discussed above regarding inadequate staffing and expertise at local health departments.  

Of the five broad categories listed in the funding announcement, use of local-level health data fits under the category “community-led air and other pollution monitoring, prevention, and remediation, and investments in low- and zero-emission and resilient technologies and related infrastructure and workforce development that help reduce greenhouse gas emissions and other air pollutants.” 

Also posted in Air pollution, Deep Dives, Risk evaluation / Authors: , / Comments are closed

Unleading Baby Food: FDA’s proposed limits are a positive step, but…

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 1, 2023

Tom Neltner, Senior Director, Safer Chemicals

What Happened: FDA recently released draft action levels for lead in foods intended for babies and young toddlers.1 Action levels represent the point above which FDA is likely to regard food as adulterated – essentially unsafe – and seek a recall. This is a key step in implementing FDA’s Closer to Zero Action Plan.

  • Lead limits would be 10 parts per billion (ppb) for most foods.
  • Limits would be 20 ppb for dry infant cereals and single-ingredient root vegetable products, because these products may have greater lead contamination levels. (Root vegetables are primarily carrots and sweet potatoes.)

The new action levels do not apply to juices; FDA proposed limits on those in April 2022.

Why It Matters: There is no safe level of lead in the diet.

For young children living in homes without lead pipes or lead paint, diet is the primary source of their lead exposure. FDA makes clear in the proposal that:

“Even low lead exposure can harm children’s health and development, specifically the brain and nervous system. Neurological effects of lead exposure during early childhood include learning disabilities, behavior difficulties, and lowered IQ. Lead exposures also may be associated with immunological, cardiovascular, renal, and reproductive and/or developmental effects. Because lead can accumulate in the body, even low-level chronic exposure can be hazardous over time.”

Lead can enter the food chain through multiple sources, including crops grown in contaminated soil and/or irrigated with contaminated water, atmospheric deposition from industrial activities, and old food-processing equipment that contains lead. The objective is to get exposure closer to zero.

Our Take: We applaud FDA’s proposed limits, which are more protective than the European Union’s 2021 standards. BUT…on the flip side:

  • FDA failed to set action levels for popular grain-based snacks, like teething biscuits and snack puffs. The agency needs to rectify this failure with all deliberate speed.
  • More protective action levels are achievable, especially for non-rice cereals and for foods that don’t contain rice or root vegetables.
  • Proposed action levels do not apply to multiple categories of foods, including:
  • FDA’s justification for the draft action levels lacks transparency—undermining both credibility of the levels and the likelihood industry will comply with them.

In addition, USDA and industry need to expand their support for research on the methods for growing, harvesting, and processing root vegetables, rice, and quinoa to further reduce lead contamination in these important foods. Research should include both store-bought and homemade baby foods.

Go Deeper: Visit our new Deep Dives blog to see our 3-part series, which provides a more detailed analysis of FDA’s proposal—including our recommendations for setting more protective limits and improving the transparency and credibility of the agency’s process of setting action levels.

NOTES
1 FDA’s guidance refers to babies and young children. Younger than two is a very narrow definition of young children, especially since children up to age six are particularly vulnerable to the harm that lead causes to their brains. Other federal agencies set standards for this broader age range. Toddlers are generally considered to be between 1 and 3 years of age. Therefore, we use the term “young toddlers” to avoid confusion.

Revised on March 21 to correct quote.

Also posted in Deep Dives, FDA, Health policy, Public health, Unleaded Juice / Read 1 Response