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GoGreenNation News: Op-ed: When it comes to food chemicals, Europe’s food safety agency and the FDA are oceans apart
GoGreenNation News: Op-ed: When it comes to food chemicals, Europe’s food safety agency and the FDA are oceans apart

The U.S. Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA) are two major global agencies in charge of food chemical safety. It is common to hear that food chemical regulations in the EU are more protective of human health than in the U.S. The latest example is the recent ban of four food additives in California. The state’s Governor, Gavin Newsom, noted that the chemicals were already banned in the EU, implying that the lack of action by the FDA was putting the health of Californians at risk. We examined the FDA and EFSA’s responsibilities on food chemical safety to better understand why EFSA decisions are in general more protective of health. We specifically looked at the agencies’ approach to the safety of bisphenol-A (BPA) as an example of disparate decision-making.We found that in the EU the risk assessment and risk management of food chemicals are made by different entities: EFSA focuses on science and the European Commission decides on how the risk is managed. EFSA is independent to follow the science on BPA, for example, which resulted in three risk assessments with the last one showing greater harm to human health. In contrast, the FDA conducts both risk assessment and management and it is unclear how decisions are made. Over the years, the FDA has reviewed BPA studies but continued to maintain that its uses are safe.As the FDA undergoes a reorganization, the agency has a prime opportunity to increase transparency, collaborations and update its approach to evaluating food chemical safety. Separation of risk assessment and management Both in the EU and the U.S., the safety of chemicals allowed in food is based on the chemical’s inherent hazard and the level of exposure. If the risk is such that public health must be protected, a risk management decision is made, often via regulation. These decisions could range from banning chemicals to establishing a consumption level that would not increase health risks. "EFSA focuses on science and the European Commission decides on how the risk is managed ... In contrast, the FDA conducts both risk assessment and management and it is unclear how decisions are made."In the EU, the risk assessment and the risk management decisions are made by different entities. EFSA conducts risk assessments and the European Commission then makes the risk management decision based on EFSA’s findings. This separation allows the risk assessment to be grounded in science and the risk management to consider not only the science but also social, political, technological and economic factors, as well as the precautionary principle.In the U.S., the FDA conducts both risk assessment and management.Striking differences in assessing and managing riskThe EFSA relies on scientific panels composed of independent experts with high standards to limit conflicts of interest and bias. There are ten permanent panels and a scientific committee that supports their work. The scientific opinions are often unanimous, but when they’re not, minority reports are published in the EFSA Journal and also inform the European Commission’s risk management decisions.Unlike the EFSA, FDA staff review safety assessment and information provided by manufacturers. In a safety assessment there usually are four sections: toxicology, chemistry, environmental impact and policy; but it is unclear whether there is an epidemiologist among the reviewers. One FDA staff member from each section writes a memo with a summary of information and the conclusions. These memos inform the risk management decision about the use of a substance. The scientific evaluation is not always publicly available. It is also unclear how and by whom risk management decisions are made and whether the risk assessors are also involved in risk management. Prioritization of chemicals for reassessmentThe EFSA is mandated by law to re-evaluate all food additives authorized for use before 2009. The EFSA also identifies emerging risks and collects data about things like consumption, exposure and biological risk and responds to similar requests from member states.In the U.S., there is no legal mandate for the FDA to re-evaluate the use of the approximately 10,000 chemicals allowed in food, many of them authorized decades ago with little or no safety data. It is unclear if there is a process to identify emerging risks. The first reevaluation of chemicals was in response to President Nixon’s 1969 directive to reassess hundreds of substances the FDA determined to be generally recognized as safe. Only recently, the FDA took the initiative to re-evaluate the safety of partially-hydrogenated oil, Irgafos 168 and brominated vegetable oil. Other reevaluations have been in response to petitions from public interest organizations. BPA: A tale of two agenciesThe risk assessment of BPA — which has been linked to myriad health problems including cancer, diabetes, obesity, reproductive, immune system and nervous and behavioral problems — in food-contact materials is a good example of how two science-based agencies have made very different risk management decisions.EFSA conducted risk assessments of BPA in 2006, 2015 and 2023, each time at the request of the European Commission in response to new science. The second and third re-evaluations resulted in reductions in the daily allowed exposure of BPA due to new evidence showing greater harm to human health. To complete the process, the Commission recently published its proposed regulation of BPA, which includes a ban of most common uses in polycarbonate plastic and metal can coating.The FDA assessment of BPA has been riddled with missteps and lack of transparency. The FDA approved BPA for use in food contact applications in the early 1960s. It didn’t a draft safety assessment until 2008, at the request of its commissioner in light of findings by the National Toxicology Program and ongoing evaluations in Europe. FDA then asked its Science Board to review the draft and establish a subcommittee; there was also a public meeting and a report. The subcommittee, which included some members of the board and external experts, had several concerns about FDA’s assessment. In 2014, the FDA published a memo summarizing an updated safety assessment of BPA. The five-page memo cites the toxicology evaluation conducted in previous years and exposure assessment using an unpublished model. The agency concluded that the estimated consumption amount of BPA was safe to protect children and adults. This was the FDA's last safety assessment. Unlike the EFSA, the FDA process is less structured and open. At the FDA "it is also unclear how and by whom risk management decisions are made and whether the risk assessors are also involved in risk management."The FDA has conducted its own studies on BPA at different life stages and in different species. The agency was a member of the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). Launched in 2012 by the National Institute of Environmental Health Sciences, the National Toxicology Program and the FDA, the aim of CLARITY was to combine a traditional regulatory toxicology study from the government and investigational studies from academics who wield more modern techniques. As part of CLARITY, the FDA also conducted a two-year guideline compliant study on BPA toxicity. In 2018, FDA concluded that “currently authorized uses of BPA continue to be safe for consumers.” This statement was based on the results of only the first year of the CLARITY two-year study conducted by FDA according to its toxicity guideline and did not include analysis of data produced by the multiple academic laboratories involved in the project. Furthermore, it was not based on an assessment of risk which also necessitates exposure data. Meanwhile, the results of CLARITY, including the academic studies largely ignored by the FDA, played an important role in EFSA’s latest BPA risk assessment. Unlike EFSA, the FDA has not made public the criteria applied to select the data, to evaluate and appraise the studies included in the hazard assessment, or the weight of evidence methodology used in its current reassessment of BPA. The lack of transparency was a concern previously expressed by FDA’s Science Board subcommittee in 2008.A “deep misunderstanding” of the risk assessment and management distinctionEFSA’s independence from risk management decisions and recruitment of independent experts to conduct risk assessments gives the agency the freedom to follow the science. By comparison, the FDA has stagnated.One explanation for such a difference would be FDA’s strong adherence to its historical decisions, rather than considering more recent science. This bias toward their own work is not conducive to change. Another explanation would be FDA scientists conflating risk assessment and risk management. In 2013, the FDA conducted a review of its chemical safety program and an external consultant noted that there appeared to be a “deep misunderstanding of the risk assessment – risk management distinction” among the staff. This observation is apparent in a commentary in Nature in 2010, where FDA toxicologists said that dismissing “out of hand” risk management factors such as economics, benefits of existing technologies, cost of replacing banned technologies and the toxic risk of any replacement “is, to say the least, insular, and surely imprudent in a regulatory setting.” The consultant added that FDA staff suggested that the agency “should not be too quick to adopt new scientific approaches.” Such an approach has likely deterred its scientists from acting on new evidence.FDA is undergoing a reorganization, including the creation of a new Human Food Program. Almost a year ago, the agency announced it was “embarking on a more modernized, systematic reassessment of chemicals with a focus on post-market review.” For this to be successful, the FDA should adopt updated processes and methods, include outside experts when it encounters challenging scientific or technical issues, increase collaboration with other agencies, and engage with stakeholders including consumers, academic institutions, public interest organizations and industry. But above all, the FDA must restore the public’s trust in the agency with a strong commitment to transparency in decision-making and clear separation between risk assessment and risk management.For more information check these summary tables.

GoGreenNation News: Proposed bill seeks to ban single-use plastic foam products in US
GoGreenNation News: Proposed bill seeks to ban single-use plastic foam products in US

Takeout containers from restaurants on the side of the road. Discarded coffee cups floating in rivers. Packing peanuts shipped off to landfills. Plastic foam products are ubiquitous. Now, a proposed congressional bill seeks to reduce this waste.In December 2023, Democratic Sen. Chris Van Hollen and Democratic Rep. Lloyd Doggett jointly introduced the Farewell to Foam Act in both the Senate and House of Representatives. The bill would ban single-use expanded polystyrene food packaging products, coolers and loose-fill packaging products like packing peanuts by January 2026. The legislators cited plastic foam’s environmental and health harms as driving the bill. Though it’s uncertain whether it will move forward, experts and advocates say its introduction is a significant step toward establishing national single-use plastic bans, none of which currently exist in the U.S.Expanded polystyrene, or EPS—erroneously referred to as Styrofoam, a trademarked material used in construction—is a fossil-fuel-derived plastic comprised of approximately 98% air and 2% plastic beads. This airiness makes EPS desirable for packaging: it insulates food, cushions products and costs little.However, Van Hollen and Doggett claim the consequences of plastic foam pollution outweigh its convenience. “As trash clutters our waterways, roadsides, and greenspaces, foam doesn’t fully disintegrate. Instead, it ever so slowly degrades into microplastics that pollute our bodies and our planet,” the Texas Rep. said in a statement.Plastic foam takes hundreds of years to break down. Within that lifespan, it can make a mess.“Foam is particularly challenging because it’s lightweight and easily breaks up into tiny, tiny pieces, like micro- and nanoplastics,” Christy Leavitt, the plastics director at the ocean advocacy group Oceana, told EHN. These pieces spread across terrestrial and aquatic habitats, leading to massive deposits that animals can mistake for food.Currently, 11 states, Washington D.C. and hundreds of cities across the U.S. have passed similar plastic foam bans. The Farewell to Foam Act, though, is the first national motion to prohibit EPS foams across the country.“It is a great time to build off of what the cities and states have been doing and to have federal action on reducing foams,” Leavitt said. Recycling challenges Some of the bill’s critics argue that bans are not the best way to keep plastic foams out of the environment. In a statement to EHN, Matt Seaholm, the president and CEO of the Plastics Industry Association, acknowledged plastic pollution as an issue but said the proposed bill was “misguided” and that time would be better spent on policies that prioritize “improving our recycling infrastructure, increasing the market for post-consumer recycled content and creating well-constructed extended producer responsibility programs.” However, while more than 10 million tons of plastic foam are produced globally each year, in the U.S., less than 10% is recycled. Most recycling stations do not accept it because it breaks into beads and cannot be processed using standard machinery. Since the material is mostly air, it’s also more expensive to recycle than to produce new materials. “I really hunger for an effective way to recycle polystyrene and upcycle polystyrene,” Guoliang “Greg” Liu, a polymer chemist and chemical engineer at Virginia Tech, told EHN. Scientists like Liu have found ways to recycle plastic foam into products with applications in manufacturing and medicine. However, the economic incentives aren’t yet widespread enough to make these processes commonplace. “We can’t just consider very cool chemistry and science. We must consider if we can do this in a realistic and scalable manner,” he said. Though recycling could help divert EPS from the polluting water and land, it wouldn’t solve the problem of its potential health risks. Microplastics, styrene exposure concerns In a press release, the legislators referenced expanded polystyrene’s tendency to leach microplastics into their contents as a human health concern. There’s also concern over the presence of styrene in it. Styrene, its resinous building block, is categorized as possibly carcinogenic by the International Research Agency on Cancer. People typically come into close contact with styrene in manufacturing workplaces, where exposure can irritate their eyes, lungs, skin and nervous systems.The U.S. Food and Drug Administration (FDA) has upheld plastic foam as a safe packaging material because the trace amounts of styrene leached into food tend to stay under the recommended daily limit and don’t necessarily exceed the amounts of styrene found naturally in foods like strawberries and nuts. However, some researchers and advocates worry about the effects of repeated exposure to styrene in EPS-packaged food. Processing styrene into expanded polystyrene tends to minimize exposure, but the amount of leached styrene can increase if the material is damaged or improperly manufactured or if the edible contents are very hot and oily. It’s unclear whether styrene leached into foods impacts human health, since most research focuses on workplace exposure. Regarding microplastics, current research suggests potential links between microplastics and increased inflammation. An important step on plastic waste Michelle Nowlin, co-director of Duke’s Environmental Law and Policy Clinic, told EHN she believes a national plastic foam ban is sound. “You think about all the other risks and threats that it poses and the difficulties with recycling it, and it just doesn't make sense to continue using the product, particularly for food ware,” she said.The U.S. Environmental Protection Agency (EPA) would have the power to enforce this ban and would give warnings and fines to violators. The ban would apply to food distributors who use plastic foam packaging, while manufacturers, retailers and distributors would be held responsible for loose fill and coolers. Single-use medical supplies would not be affected. As of March 2023, the bill has been referred to the Committee on Commerce, Science, and Transportation in the Senate and the Subcommittee on Innovation, Data, and Commerce in the House. The committees have yet to review the bill, but 86 congresspeople (all Democrats except for 2 independents) across both chambers have signed on as co-sponsors. However, it appears unlikely that the bill will pass by January 2025, when the current Congress ends, as it has been one of the least productive legislative bodies in American history. Nowlin added that the political polarization of the 118th Congress has stymied many bills from passing. However, Nowlin still believes that this bill’s proposal is an important step. “Introducing these types of provisions is really important to elevate the national consciousness, to get these conversations started,” she said. “We’ll get there eventually.”

GoGreenNation News: Op-ed: An open letter to the Food and Drug Administration Commissioner
GoGreenNation News: Op-ed: An open letter to the Food and Drug Administration Commissioner

The U.S. Food and Drug Administration (FDA) is going through a major reorganization to improve efficiency and protect public health. A recent hearing in front of the House Committee on Oversight and Accountability concluded that the agency stumbles from crisis to crisis, including drug shortages, tainted food and illicit tobacco scandals in recent years.Although crises such as the contamination of baby food with heavy metals like lead and mercury gain public attention, the scientific approach used by FDA to regulate chemical additives in food is much more opaque. While it largely flies under the public radar, the agency’s neglect to update its testing to reflect modern science and modern food chemical hazards is a decades-long crisis that impacts all of our health. The agency has fallen behind other nations’ testing and regulations and is not even following laws put in place nearly 70 years ago to keep us safe. We are calling on FDA Commissioner, Dr. Robert M Califf, to use the agency reorganization as an opportunity to overhaul its approach to chemicals in our food and put public health at the center of its work. How does the FDA evaluate the safety of food additives and contaminants?Recently, the FDA published a consumer update entitled, “Is food safe if it has chemicals?” In it, the agency says that it’s the amount of a chemical in food that determines its risk to our health. They use sodium as an example. While it largely flies under the public radar, the agency’s neglect to update its testing to reflect modern science and modern food chemical hazards is a decades-long crisis that impacts all of our health.We need sodium to live, but too much sodium can be bad, so they publish guidance on the safe level of sodium to be consumed each day. But many of the chemicals that wind up in our food are not required for us to live, such as bisphenols like BPA, phthalates or the group of chemicals known as PFAS or “forever chemicals”. In fact, many of these are not required for food production, but leach into food from packaging and equipment. FDA noncompliance The FDA discusses how they intentionally determine an “acceptable daily intake” for a chemical that includes a safety margin. The idea is that this safety margin is so conservative that it will always protect public health.However, we know chemicals in the diet can come from a variety of food sources and that different chemicals can have the same adverse effect. This is so well-known that the 1958 amendment to the Food, Drugs and Cosmetic Act of 1938 required that FDA evaluate the “cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet.”Sixty-six years later and the FDA has never complied with this part of the law. A good example: its guidance for lead in baby food, in which they set the suggested (not required) limit to be 20 parts per billion. However, there is no safe blood level of lead, which hurts children’s brains, resulting in lower IQ and behavioral problems among other harmful effects.It’s not just lead: recently, the Dutch risk assessment agency reported that the combined exposure to lead, methyl-mercury, arsenic, polychlorinated biphenyls or PCBs, polybrominated diphenyl ethers or PBDEs and fluoride were much more potent at reducing children’s IQ than any one of these chemicals alone.Similarly, the FDA continues to defend its ruling that current levels of BPA in food are safe despite the decision by the European Food Safety Authority, the EFSA, to reduce the “safe level” of BPA by 20,000 fold. The FDA defends its position by focusing on BPA as if it is the only chemical in foods that act like the female hormone estrogen. In contrast, it is well known that plastic food packaging contains a number of estrogen-like chemicals, like other bisphenols and phthalates, that can leach into foods.The failure of the FDA to comply with the 1958 amendment to food safety law is not just a violation of the law but presents a significant risk to American consumers. A citizen’s petition was filed with the agency in 2020 to attempt to cajole it into compliance. The FDA has never responded.Considering this, we wrote to Commissioner Califf to address this serious shortcoming of FDA’s Human Food Program. The Commissioner has not responded. The letter is re-printed below.March 11, 2024Robert M Califf, M.D., CommissionerUnited States Food and Drug AdministrationCc: James Jones, Ph.D., Deputy CommissionerFDA Human Foods Program Dear Commissioner Califf, We read with great interest your OpEd with Dr. Warraigh entitled, “Four steps toward meeting the challenge of chronic disease” (The Hill, 02/15/24). This is a particularly important issue considering that the United States is below average compared to peer economies in 9 health domains, including adverse birth outcomes, obesity and diabetes, heart disease and chronic lung disease. And this, as you point out, is despite US taxpayers spending nearly 18% of our GDP on healthcare.However, we are concerned that there was no mention of food-borne chemicals that are either added to food intentionally or that migrate into food from packaging or processing. The recent analysis by the New York Times of the failure of the food safety system that resulted in hundreds of children being poisoned by lead in applesauce illustrates in part how our system of food safety needs to be improved.More important to the issue of chronic disease is that of chemicals in the food supply that are being evaluated for safety in a one-by-one approach, rather than considering the “cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet” as required by the 1958 amendment to the Food, Drugs, and Cosmetic Act of 1938. Recent studies demonstrate that the cumulative effect of Americans’ exposure to endocrine-disrupting chemicals in the food supply contributes to harmful health impacts including chronic disease, increasing healthcare costs in the hundreds of billions of dollars annually, as well as affecting quality of life. Importantly, the scientific evidence is sufficient to conclude that the cumulative effects of biologically related substances in the food supply contributes to chronic diseases such as obesity or diabetes. We urge you to consider it as a critical “fifth step” in meeting the challenge of chronic disease in the United States, one that the agency is already mandated to conduct.For example, a recent study contributed by the Dutch risk assessment agency (RIVM) in collaboration with Professor Andreas Kortenkamp, a world-leader in the analysis of cumulative risk, demonstrated that in 9 countries in the EU, their populations exceeded combined tolerable levels of exposure to a mixture of chemicals at median exposure levels. Thus, the traditional way of identifying a “Tolerable Daily Intake” using a chemical-by-chemical basis is clearly underestimating the cumulative risk of chemicals with similar structure or observable effects.Despite the 1958 amendment requiring the FDA to evaluate cumulative effects of chemically related and biologically related substances in the diet, the agency has never performed this analysis for any chemical additives. Moreover, the FDA has not responded to citizen petitions or Congressional queries asking for the FDA to comply with the spirit and letter of this law. It simply is past time that the Agency stop ignoring the law and incorporate cumulative risk assessments in their regulatory approaches.We ask that FDA form a committee of its Science Board including external experts to guide the agency as it addresses this shortcoming in its current safety assessment methods. When it passed the 1958 law, Congress recognized that chemicals, even ones that are not chemically related, may impact organs such as the thyroid and systems such as the cardiovascular with different mechanisms of action but cumulatively have a greater negative effect on the health of the American people.Finally, we are happy to meet with you to provide further information and insight or to contribute to the changes that need to be made in any way that we can.Sincerely,Linda S. Birnbaum, Ph.D., D.A.B.T., A.T.S.Scientist Emeritus and Former DirectorNational Institute of Environmental Health Sciences and National Toxicology ProgramScholar in Residence, Nicholas School of Environment, Duke UniversityR. Thomas Zoeller, Ph.D.Professor EmeritusUniversity of Massachusetts Amherst

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