Loopholes in American EDC Regulation: Phthalates
Interview and Analysis Conducted by Dayna Pham
Phthalates are endocrine disruptors used in polyvinyl chloride plastics and as solvents in common consumer products, oftentimes used in the packaging of fast food items and foods sold in convenience stores. In America, the Food and Drug Administration (FDA) approves the use of phthalates and equipment that handles and processes our food, which also acts as points of exposure, since phthalates can leech out of EDC-contaminated materials and into our food (Wypych 2017). To explore further into the regulation of EDC’s such as phthalates, the research team here at Transformative Food Solutions consulted with chemical policy expert, Dr. Lariah Edwards (Pham 2022).
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Dr. Lariah Edwards is a postdoc working at George Washington University’s Milken Institute School of Public Health. She splits her time at the Environmental Defense Fund, a nonprofit advocacy organization, where works specifically on their health program team analyzing the Toxic Substances Control Act (TSCA) (United States Environmental Protection Agency 2021). When asked on her perspective about phthalate regulation in America, she stated that policies are largely inconsistent – the Consumer Product Safety Commission (CPSC) deemed that eight phthalates are unsafe to be used in children’s toys as children may be exposed by placing toys in their mouths, but the CPSC does not apply the same amount of oversight to potential phthalate exposure in food items. Dr. Edwards expressed the same amount of concern that our team did when briefed about this topic, stating, “If phthalates are unsafe to be used in children’s toys, why is it okay that they’re used in materials that then allow phthalates to get in our food? That’s what I mean by the policies being inconsistent.” We believe that stronger regulations could ensure that Americans are not exposed to phthalates in their food.
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The Toxic Substances Control Act is a United States law administered by the Environmental Protection Agency (EPA) in 1976, which gave the EPA the authority to regulate restrictions, reporting, and testing regarding chemical substances and potential modes of exposure in the United States. However, there exists regulatory loopholes in the TSCA that allow companies using EDCs in their products to circumvent the TSCA-required safety review processes. For example, in America, one of the biggest loopholes in EDC regulation are the Generally Recognized as Safe (GRAS) rules, which state that ingredients added to food must undergo the safety review process unless they are GRAS ingredients (Anderson 2019).
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With the GRAS rules, ingredients that have undergone general safety evaluations by experts and have been “proven” not to cause harm are deemed appropriate to be used as food additives, as the specific food additive approval and review process is quite lengthy (Pham 2022). What researchers like Dr. Edwards are concerned about is who evaluates the health of these GRAS ingredients. In the scientific community, there are always individual interests in mind based on who funds their research; the question is if these food additive evaluators have the interest of public health in mind, or if there are certain conflicts of interest based on their organization’s stakes on certain food additives.
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In general, progress has been made – in 2016, the Frank Lautenberg Chemical Safety Act was signed into law as an amendment to the TSCA, making regulations generally stronger. The amendment included specific language requiring the EPA to consider how chemical exposure can disproportionately affect different subpopulations, such as children, the elderly, workers, and pregnant women. This new language aims to particularly protect these populations, but although we recognize the improvements that have been made, the issue of EDC exposure in America is still alive. Endocrine disrupting chemicals may be more strictly regulated, but their presence is undeniable in food packaging materials. EatingTogether Consulting concurrently works with policymakers to discuss the TSCA and its amendments, as well as connecting community members to policymakers to support them in amplifying their narrative and needs (United States Environmental Protection Agency 2021).
Screenshot from Dayna Pham's Interview with Dr. Lariah Edwards.
"If you don't have the money, if you don't live in the right neighborhood, if you are a person of color - you don't always have access to many options that are better for your health so really, we need to have better regulations that make ingredients more transparent on labels, and have stricter regulations for chemicals that are used in materials that have come in contact with our foods."
Dr. Lariah Edwards
Loopholes in Current EDC Policy in the U.S. - An Interview by Dayna Pham
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Interview Transcript
Dayna Pham (she/her): This is Dr. Lariah Edwards, thank you for joining me on our interview today, as we explore the loopholes behind EDC Regulations in the United States. Can you introduce yourself a bit?
Lariah Edwards (she/her): I’m a postdoc and I am working at George Washington Milken Institute School of Public Health. I'm also splitting my time at the Environmental Defense Fund, a nonprofit advocacy organization and I work, specifically on their health and their health program on the Toxic Substances Control Act (TSCA), so a lot of chemical policy work.
Dayna Pham: Gotcha, thank you! I will be starting with my first question: What is your current point of view on policies surrounding EDC exposure in food and food packaging?
Lariah Edwards (she/her): So I can speak to that specifically for phthalates and for phthalates when it comes to food and food packaging, I would say that the regulations are, you know, inconsistent, especially when you consider that the primary way people are exposed to phthalates is through diet, so that is probably the most important exposure source for phthalates, at least in you know American population. So, the FDA, Food and Drug Administration, they allow or approve the use of phthalates and a lot of equipment that handles and processes our food, so think conveyor belts that food travel down and factories, or tubing, or tanks. All of these other things that come in contact with our food, and so the phthalates then leech out of these materials that are, you know, surrounding our food and we get into our food and then we then ingest the contaminated food. And like I mentioned earlier, that the policies inconsistent, so phthalates have been briefly regulated, the Consumer Product Safety Commission deemed that eight phthalates are unsafe, to be used in children's toys, because children often put, you know, toys in their mouth and they would then be exposed to phthalates. If phthalates are unsafe to be used in children's toys, why is it okay that they're used in materials that then allow phthalates to get into our food? So that's what I mean by it's just inconsistent and stronger regulations could ensure that people aren't exposed to phthalates in their food.
Dayna Pham: That's a really good perspective, and do you know anything about other countries and their regulations on phthalate exposure? Because I heard that, like in the EU, they have a “If you are unsure if it’s safe, it shouldn’t be allowed,” but then here it’s like “If you can’t confirm that it’s unsafe, it’s allowed.”
Lariah Edwards (she/her): Yeah, what you described is a precautionary principle which is one of the main chemical bodies in the EU, they have when it comes to their chemicals, so the burden of proof is on the chemical companies. You have to prove that the chemicals are safe to use before you put them in products that people are exposed to, whereas in the US, one of the chemical policies is the Toxic Substances Control Act (TSCA), which monitors chemicals in certain products. Unfortunately, the regulations aren't as strong, I mean they've gotten stronger thanks to amendments to TSCA, but really the precautionary approach that you see in other countries is not quite relevant or as prominent here, unfortunately.
Dayna Pham: Oh! I learned about the precautionary principle in class, and I can see how the US does not apply that. How have the amendments to TSCA affected potential protection from exposure?
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Lariah Edwards (she/her): I believe TSCA was 1976 and it was enacted and it was amended in 2016 and by the Frank Lautenberg Act. Those were the amendments to TSCA, and I will say those amendments did make TSCA much stronger. And one of the really great things about the amendments to TSCA in 2016 that happened is they were specific language, where EPA has to consider how chemicals that people are exposed to in these products can affect potentially exposed or susceptible subpopulations, such as children, elderly, workers, pregnant women so there's specific language in TSCA now after the updates for these subpopulations need to be particularly protected, which is great from like a population health standpoint, because, as you mentioned, we were discussing earlier that not all groups of people are exposed and experience health outcomes chemical exposure the exact same way, so you have to look at specific subpopulations and groups to really understand what are the risks that they experience to really be protective of public health.
Dayna Pham: I feel like it’s the people who are the most affected that try their best to advocate for themselves, but they are the least listened to unfortunately. I guess that’s what our project is trying to do, via a community-based approach where individuals from these subpopulations can share their needs and we’re here to amplify their voices and connect them to the people that they need to lead their own efforts in advocacy for food access. We think a community-based approach is good because higher-ups often think they know what’s best for the people, but those in power seem to not really ask what the people want.
Lariah Edwards (she/her): I agree, I think that is a lot of the lot of concerns when it comes to issues that affect specific communities they are vocal or they try to be vocal and sometimes they aren't being heard they aren't being listened to, and I feel like... It is the job of both you know policymakers and scientists, if you want to help communities you should listen to them first because they often really do know what is affecting them. They know what their top concerns are and, obviously, you know community members, they may not be scientists, they may not be policymakers, so like you do have certain skill sets of scientists, of policymakers, that you can bring to the table, but also community members also have valuable knowledge, they have know-how, they have concerns that they should bring to the table and should be heard.
Dayna Pham: Okay, so I guess that goes perfectly into my next question: Do you know of any loopholes that exist in legislation against chemicals in food?
Lariah Edwards (she/her): Yeah, so I think one of the biggest loopholes is the GRAS regulation, so Generally Recognized As Safe. And so what this allows is that ingredients that have undergone safety evaluations by experts and have been proven not to cause harm are deemed okay to be used as food additives and what a lot of people are concerned about is that this method helps to avoid this time consuming process of getting food additives or ingredients approved by FDA because it can be a lengthy process, but there's concern about who is actually evaluating the health of these chemicals that are considered GRAS ingredients and whether or not those folks have the best interest which is should be protecting public health in mind, or is there some other conflict of interest. Especially if these experts evaluating the safety of the chemical, you know, work for this company or they, you know, they have a stake in this food additive being used in these products, so that is the real concern about this GRAS regulation and GRAS ingredient concerned, it was passed I think in 1958. In the past, there was far less use of these newer synthetic chemicals that you see in, food products now right so you know, back in the day, maybe this was less of a concern, but now, when we see so many new words synthetic chemicals being used really almost everywhere, it seems. This GRAS ingredient exemption or loophole is concerning and I think a lot of advocates in health organizations have raised concerns about this grass ingredient loophole.
Dayna Pham: And that also connects, to the point you're making earlier about like how policy is not only inconsistent, but also largely unspecific – with the “generally” in GRAS and what does “generally” even tell you? I didn’t even think about conflicts of interests either, but it makes sense. At the end of the day, it’s all about money and putting profit over people.
Lariah Edwards (she/her): Right, the concern should really be about protecting public health, making sure that anything that is put in consumer products that are marketed to people are safe, that hey've passed some type of safety evaluation and we understand that they are not going to cause harm, either now or long term.
Dayna Pham: Thank you so much. Okay, and the next question I had is, what are the major health effects of phthalate exposure and why do you think they're not widely expressed to the public and or under researched?
Lariah Edwards (she/her): Yeah, so phthalates are known as EDC disruptors, which you know, so they they disrupt hormones. There's been a lot of evidence, particularly from animal toxicology studies linking phthalate exposure to male reproductive effects, so these are typically under this bracket called anti-androgenic effects, which means that they decrease circulating testosterone levels, which then causes a host of problem such as decreased angiogenic genital distance, it can also cause decrease sperm count in fertility and that's what a lot of the literature from animal toxicology to have seen in terms of phthalate exposure. Another growing area of concern when it comes to phthalates are the concerns around children's neurodevelopmental health, because the animal studies that looked at effects found that when pregnant moms are exposed to phthalates, their offspring have male reproductive harm. So this idea that if a mother is exposed, offpsring can also have also have a adverse health effects as well, so they're seeing a link between prenatal phthalate exposure and you know, problems with children's development such as learning attention behavioral problems. There's really just a lot of traffic on the epidemiology field discussing those concerns.
Dayna Pham: Although we know about the health outcomes of EDC exposure, why do you think that the health concerns are not emphasized as a crucial part of one’s health outcomes? The fact that exposure could lead to a great diminishing of your health over time?
Lariah Edwards (she/her): I think it’s the fact of just the way you said it – over time. It’s hard to convey health effects to the public if the effects aren’t immediate. These chemicals that you're exposed to over time and small amounts can cause these small changes in your body that lead to these health outcomes that's not as easy as saying you know this chemical is correlated to cancer, you know. Media expresses things to the public in a very digestible manner, even journalists, so I feel like it would be difficult to talk about the different mechanisms through which EDCs affect the body, as it’s a complicated process.
Dayna Pham: And you can’t really get to the meat of it if you don’t understand the process…
Lariah Edwards (she/her): Right mm hmm.
Dayna Pham: My next question is: how can we raise consumer awareness about endocrine disruptors and everyday products and their packaging? But will this even matter, because those living in areas without access to fresh food or those who choose to or those who are forced to choose fast food and foods with higher EDC exposure? For people that don't really have autonomy over that – like it's either you eat a food with an EDC or you don't eat it all, which is a decision like, no one should ever have to make.
Lariah Edwards (she/her): You right that's a very difficult question and it doesn't really have a clearer perfect answer I, like you, like you said it's easy for me to say, like consumers need to read labels more carefully, and that applies more to like consumer products and beauty products. Or, they should shop, they should stop buying unprocessed foods, because, you know, there have been links to processed food consumption and phthalate exposure, or they eat out less or only by clean products, but those are unfair solutions that are not accessible to everybody. If you don't have the money, if you don't live in the right neighborhood, if you are a person of color like you don't always have access to these options that are better for your health so really, we need to have better regulations that make ingredients more transparent on labels that have stricter regulations for chemicals that are used in materials that have come in contact with our foods. It's hard for consumers, so regulations could ensure that everybody has access to healthier options, no matter if its food, beauty products, or whatever it is.
Dayna Pham: Thank you so much for your insightful answers and I learned a lot from this interview. I love how you dissect the intersectionality of this issue of phthalate and overall EDC exposure, as we parse through the harsh realities of pushing for stricter policies and regulations that protect the health of the public. I really appreciate your time, Dr. Edwards.
Lariah Edwards (she/her): No problem, it was wonderful speaking with you. Good luck on your project!
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