Goodness gracious how I have missed you, my packaging and sustainability friends! The last couple weeks have been absolutely CRAZY, which is why I have failed to post recently. Let’s see where did we leave off…that’s right, The Truth about Plastic Packaging Report! As narrated in my last several posts, I wanted to use Dordan’s sponsorship of Packaging World’s New Issue Alert as the platform to release our newest research report, titled The Truth about Plastic Packaging in reference to our first research report, The Truth about Recycling?. The motivation for this project stemmed from several happenings, the most prominent, reading Susan Freinkel’s recently published Plastic: A Toxic Love Story. This book is an in-depth look at “plastic” as it exists in the social imaginations of the Western world and is in dialogue with the various social and environmental issues pertaining thereto. Having no ties to special interests groups (to my knowledge), Freinkel presents a fair, well-researched treatment of plastics as they have come to proliferate the modern world. Her objective, academic approach provided me—as a representative of the plastics industry—with tons of food for thought; so much so I decided it would best be analyzed and applied in a research report of my own. Thereafter, I set upon a new research venture that looked to expose the realities of plastics as they pertain to us and our environment in hopes that in painting a contextualized portrait of plastics, the industry would better understand both the obstacles that exist, and opportunities ahead, for plastics.
And behold the genesis of The Truth about Plastic Packaging Report! While in the thick of it, however, I quickly discovered that this was a massive undertaking: there was no way I could discuss and contextualize PVC and BPA, ocean debris, end of life management issues, AND “green” plastics in one research report. Sooooo I decided to break it into a series, as discussed in a previous post, the first of which, titled The Truth about BPA & PVC. Upon completion of this task, however, something just didn’t sit right with me. Why was I talking about how the additive in flexible PVC (DEHP) may or may not be contributing to the contemporary discourse on “endocrine disruptors”? What does this do for the thermoforming, and larger plastics, industry?
Perhaps my real hesitation with publishing The Truth about BPA & PVC was the feedback I got from my friend and colleague from CalRecycle, formally of the California Board of Integrated Waste Management, who provided a great deal of insight into my first report, The Truth about Recycling. After reading The Truth about BPA & PVC he became concerned that the argument I took was outdated and reflective of my bias as a representative of the plastics industry. He explained that the way I critiqued the studies investigating the effects of phthalates like DEHP on the endocrine system (the complex network of glands that produces hormones that govern growth, development, metabolism and reproduction) was similar to that of the ACC, which reasons: the test sample size is too small, rats are poor models of human health hazards, the dose administered in animal studies are much higher than those experienced in humans, and, the demonstrative health qualities are not necessarily adverse*. I explained to my colleague that I was not making an argument akin to the ACC; I was just describing the contemporary studies on the matter and the discourse resulting therefrom as articulated in Freinkel’s Plastic: A Toxic Love Story. Regardless of my intentions to present a fair treatment of plastics as contributing to discussions of “endocrine disruptors,” I concluded that I did not know enough about the matter to speak about it in The Truth about BPA & PVC. And in the vein of attempting to appear as though this decision was based on a deep-rooted philosophy of ethics as opposed to uncertainty over ones understanding of a complicated issue, let me quote Socrates: “As for me, all I know is that I know nothing” (The Republic). Did it work; am I just dripping with depth?!?
To make a long story short, we are reverting back to our original plan to discuss The Truth about Plastic Packaging as one, mega-report. I will use the information I garnered for The Truth about BPA & PVC to inform my holistic discussion of plastics and the environment from the perspective of the Sustainability Coordinator at a family-owned plastics packaging manufacturer. While I will use Freinkel’s book as the backbone for the analysis, I will consult other sources in order to develop a multi-dimensional assessment of the current climate of plastics and the environment. SO, STAY TUNED!
If you are interested in a summary of the discussion on plastics and endocrine disruptors, check out the excerpts from my report below. As described at length above, take this information with a grain of salt as more research is needed to be performed on my end until I can understand and therefore discuss this complicated topic!
AND, I have my first conference call with the SPC/AMERIPEN today on financing end of life management for packaging materials! Wish me luck!
To check out the content that we DID use for our sponsorship of Pack World’s NIA, click here! Do you like the photo?!? It’s ME!
Excerpt from the unpublished Truth about BPA & PVC
Please note: WordPress format does not allow me to include footnotes; please email me at cslavin@dordan.com for a list of references.
Nowhere has plastic become more omnipresent then in modern healthcare. Dutch physician Willem Kolff, motivated by assurance that “what God can grow, Man can make,” scrounged sheets of cellophane and other materials in Nazi occupied Holland to perfect his kidney-dialysis machine. Today,
Plastic pacemakers keep faulty hearts pumping, and synthetic veins and arteries keep blood flowing. We replace our worn-out hips and knees with plastic ones; and, plastic scaffolding is used to grow new skin and tissues. Plastics supply the essential everyday equipment of medicine, from bedpans to bandages to single use gloves and syringes. With plastics, hospitals could shift from equipment that had to be sterilized to blister-packed disposables, which improved in-house safety, significant lowered costs, and made it possible for more patients to be cared for at home.
While medicine is a small market when compared with plastics’ other applications, it has been revered as the industry’s golden child, showcasing the benefits of polymers. Such association between plastics and healthcare was done so, however, on the presumption that plastics were safe and chemically inert. As Modern Plastics pointed out in a 1951 article titled Why Doctors are Using More Plastics, “Any substance that comes into contact with human tissue…must be chemically inert and non-toxic, as well as compatible with human tissue and not absorbable.” But in the late 1960s and early 1970s, a sequence of findings began challenging this assumption of chemical stability.
PVC is one polymer used in healthcare for its presumed chemical stability. PVC has chlorine as one of its main components, a greenish gas that is derived from sodium chloride. To make PVC, the chlorine is mixed with hydrocarbons to form the monomer vinyl chloride, which is then polymerized, resulting in a fine white powder. “This unusual chemistry is PVC’s great strength, but also its greatest problem—the reason that industry sings its praises and that environmentalists call it Satan’s resin”: The chlorine base makes PVC chemically stable, fire resistant, waterproof and cheap (since less oil or gas is needed to produce the molecule); it also makes PVC dangerous to manufacture and hazardous to dispose of, because when incinerated it releases dioxins and furans, two carcinogenic compounds. PVC is also unusually “poly-amorous,” which means it tends to hook up with a variety of other chemicals, allowing it to be converted for an array of applications; without additives, PVC is so brittle it is basically useless. This versatility has made PVC one of the top-selling plastics in the world and a frequent choice for manufacturers of medical devices. Due to its dependence on additives, however, it has come under scrutiny.
Plasticized PVC is when the plastic is made soft and pliable through the addition of a clear, oily liquid called di (2-ethylhexyl) phthalate, or DEHP, a member of the phthalate family. Phthalates have become so ever-present in consumer and industrial products that manufacturers make nearly half a billion pounds of them each year; they’re used as plasticizers, lubricants, and solvents. While you’ll find phthalates in anything made of soft vinyl, they also exist in other types of materials, too. Examples include: food packaging and food processing equipment, construction materials, clothing, household furnishings, wallpaper, toys, personal-care products like cosmetics, shampoos and perfumes, adhesives, insecticides, waxes and inks, varnishes, lacquers, coatings, and paints. But our primary exposure to DEHP is through fatty foods such as cheese and oils, which are particularly likely to absorb the chemical, though it is unclear whether that is happening via plastic packaging, the inks used in food wrapping, or during commercial preparation and processing. There are about 25 different types of phthalates, but only about a half a dozen are widely used; of those, DEHP is one of the most popular, especially for medical devices.
In a 1969 experiment Johns Hopkins University toxicologists Robert Rubin and Rudolph Jaeger accidently discovered that DEHP was leaching out of PVC blood bags because DEHP is not atomically bonded to the molecular PVC daisy chain; therefore, can migrate out, especially in the presence of blood or fatty substances. Follow up studies found traces of DEHP in stored blood as well as in the tissues of people who had undergone blood transfusions. Thereafter, a chemist at the National Hearth and Lung Institute reported that he found residues of DEHP and other phthalates in blood samples taken from a sample population of one hundred people. Unlike the former findings, however, this population had not undergone extensive medical treatment; these people were simply the consumers of synthetic goods, those who may have been exposed to phthalates from any of thousands of everyday products, from cars to toys, wallpaper to writing. Today, at least 80% of Americans—of all ages, races and demographics—now carry measurable traces of DEHP and other phthalates in their bodies, according to biomonitoring studies by the Centers for Disease Control. Yet as the CDC has articulated, “the mere presence of DEHP in someone’s body does not mean it is a health hazard. The difficult question is whether the small amounts to which we are all exposed are significant to affect some people’s health." Plastics manufacturers had long known that additives could and would leach out of polymers but maintained that people weren’t exposed to high enough levels to suffer any harm. After taking a hard look at DEHP and other phthalates, independent toxicologists came to the conclusion that only at very high doses could DEHP/phthalates cause birth defects in rodents and induce liver cancer in rats and mice, but only through a mechanism that rarely affects humans. Hence, it was concluded that there was no cause for concern, based on the fundamental principle of modern toxicology that the dose makes the poison.
This assumption that the dose makes the poison was challenged, however, by mom- turned-zoologist Theo Colborn, who began developing a different theory of toxic effects based on her work in the late 1980s at the Conservation Foundation in Washington. Enlisted to research the effects of pesticides and synthetic chemicals on the Great Lakes wildlife, Colborn found “weird, eerie accounts of chicks wasting away, cormorants born with missing eyes and crossed bills, male gulls with female cells in their testes, and female gulls nesting together.” Sensing something lurking beneath the surface, Colborn created an electrical spreadsheet sorting the information by species and health effect and found that most symptoms could be traced to a dysfunction of the endocrine system—the network of glands that produces hormones and govern growth, development, metabolism and reproduction. Colborn discovered that adult animals exposed to chemical toxins were fine; the main health problems were found in their offspring. Colborn wrote, “Unlike typical toxins, these seemed to be acting as hand-me-down poisons.” Colborn’s findings suggested the possibility that wildlife and people were being exposed to a new kind of risk from widely used chemicals—this changed the assumption that the dose makes the poison—insofar as the poison wasn’t solely in the dose; it could also be in the timing of exposure. In July 1991 at the Wingspread Conference Center in Racine, Wisconsin, a group of members from a range of disciplines dubbed these trends “endocrine disruption,” which included three important findings often overlooked by traditional toxicological research: the effects could be transgenerational; they depend on the timing of the exposure; and they might come apparent only as the offspring developed. A discussion of endocrine-disrupting suspect bisphenol A will make clear the ambiguous effects of these compounds on the human body.
BPA is the primary component of polycarbonate, a hard, clear plastic that’s used in baby bottles, compact discs, eyeglass lenses, and water bottles; BPA is also a basic ingredient of epoxy resins used to line canned foods and drinks. Unfortunately, the bonds holding these long molecules together can be weakened fairly easily, allowing BPA to migrate out of the polymer daisy chain. Scientists have known since the 1930s that BPA acts as a weak estrogen, binding with estrogen receptors on cells and blocking natural stronger estrogens from communicating with cells. By now hundreds of studies have suggested BPA does just that in animals and humans, reporting the compound causes health effects in cells and animals that are similar to diseases becoming more common in people, such as: breast cancer, heart disease, type 2 diabetes, obesity, and neurobehavioral problems such as hyper activity. BPA research has been highly controversial because the alleged effects seen at very low doses don’t show up at higher doses; yet, it makes sense if you view the chemical as hormone rather than poison in which toxic effects increase with the amount of exposure.
Unlike most suspected endocrine disruptors like BPA that mimic estrogen, DEHP—the chemical found in PVC IV bags and tubing, not to mention a host of other vinyl items like shower curtains—is an antiandrogen, meaning it interferes with testosterone and other masculinizing hormones of both men and women. As observed in rat studies, once the chemical enters the body, it travels to the pituitary where it stops the production of a hormone that directs the testicles to make testosterone. It is believed that when this occurs during sensitive periods of development, testosterone levels can plummet and growth and development may be influenced. Epidemiologists have charted rising rates of male infertility, testicular cancer, and decreased testosterone levels and diminished sperm quality in many western countries, though the connection to DEHP is unknown. Such findings led an expert panel convened by the National Toxicology Program in 2006 to conclude that there were “grounds for concern that DEHP exposure can affect the reproductive development of baby boys under the age of one.”
While DEHP is thought to affect cells in the testes that secrete testosterone, such findings have not been observed in recent primary studies involving young marmosets, our closest relatives. Moreover, epidemiological findings on sperm quality have been inconsistent: some studies show correlations with phthalate levels, some don’t. These contradictions in DEHP/phthalate studies have led the American Chemistry Council to make the following critiques thereof: the sample size is too small; rats are poor models of human health hazards; the dose administered in animal studies are much higher than those experienced in humans; the demonstrative health qualities are not necessarily adverse. The continuing uncertainties are one reason why expert panels that have looked at these compound all come to the same conclusion: more and better studies are needed.
A few of the chemicals used in plastics—the phthalates found in IV bags, triclosan, an antibacterial found in kitchenware and toys, and the brominated fire retardants widely used in furniture—have already caught the attention of researchers and regulators. However, we have no coherent body of law for managing the chemicals we experience in daily life, which makes the regulation of suspected endocrine disruptors difficult. The EPA recently announced it would take steps to limit use of phthalates, including DEHP. The FDA, on the other hand, judges that the chemical offers more benefit than risk and therefore has ignored calls to limit its use in medical devices; its only action to date has been a 2002 advisory recommending that hospitals not use devices containing DEHP in women pregnant with boys, in young male infants, and in young teenage boys. This inconsistent approach to chemicals management is part and parcel of The Toxic Substance and Control Act (1976), which presents the following Catch-22: The EPA needs evidence of harm or exposure before they can require a chemical manufacturer to provide more information about a chemical, but without that information, how do they establish evidence of harm? In the absence of evidence, regulators cannot act. In Europe, law makers abide by the precautionary principle in which “the burden of proof is on safety rather than danger.” This allowed the EU to prohibit the use of DEHP in children’s toys in 1999, nine years before the US Congress pass similar legislation. A new directive known as REACH (Registration, Evaluation, and Authorization of Chemicals), adopted in 2007, requires testing of both newly introduced chemicals and those already in use, with the responsibility on manufacturers to demonstrate that they can be used safely.
SO, what do you think? Confusing, eh?
And behold the genesis of The Truth about Plastic Packaging Report! While in the thick of it, however, I quickly discovered that this was a massive undertaking: there was no way I could discuss and contextualize PVC and BPA, ocean debris, end of life management issues, AND “green” plastics in one research report. Sooooo I decided to break it into a series, as discussed in a previous post, the first of which, titled The Truth about BPA & PVC. Upon completion of this task, however, something just didn’t sit right with me. Why was I talking about how the additive in flexible PVC (DEHP) may or may not be contributing to the contemporary discourse on “endocrine disruptors”? What does this do for the thermoforming, and larger plastics, industry?
Perhaps my real hesitation with publishing The Truth about BPA & PVC was the feedback I got from my friend and colleague from CalRecycle, formally of the California Board of Integrated Waste Management, who provided a great deal of insight into my first report, The Truth about Recycling. After reading The Truth about BPA & PVC he became concerned that the argument I took was outdated and reflective of my bias as a representative of the plastics industry. He explained that the way I critiqued the studies investigating the effects of phthalates like DEHP on the endocrine system (the complex network of glands that produces hormones that govern growth, development, metabolism and reproduction) was similar to that of the ACC, which reasons: the test sample size is too small, rats are poor models of human health hazards, the dose administered in animal studies are much higher than those experienced in humans, and, the demonstrative health qualities are not necessarily adverse*. I explained to my colleague that I was not making an argument akin to the ACC; I was just describing the contemporary studies on the matter and the discourse resulting therefrom as articulated in Freinkel’s Plastic: A Toxic Love Story. Regardless of my intentions to present a fair treatment of plastics as contributing to discussions of “endocrine disruptors,” I concluded that I did not know enough about the matter to speak about it in The Truth about BPA & PVC. And in the vein of attempting to appear as though this decision was based on a deep-rooted philosophy of ethics as opposed to uncertainty over ones understanding of a complicated issue, let me quote Socrates: “As for me, all I know is that I know nothing” (The Republic). Did it work; am I just dripping with depth?!?
To make a long story short, we are reverting back to our original plan to discuss The Truth about Plastic Packaging as one, mega-report. I will use the information I garnered for The Truth about BPA & PVC to inform my holistic discussion of plastics and the environment from the perspective of the Sustainability Coordinator at a family-owned plastics packaging manufacturer. While I will use Freinkel’s book as the backbone for the analysis, I will consult other sources in order to develop a multi-dimensional assessment of the current climate of plastics and the environment. SO, STAY TUNED!
If you are interested in a summary of the discussion on plastics and endocrine disruptors, check out the excerpts from my report below. As described at length above, take this information with a grain of salt as more research is needed to be performed on my end until I can understand and therefore discuss this complicated topic!
AND, I have my first conference call with the SPC/AMERIPEN today on financing end of life management for packaging materials! Wish me luck!
To check out the content that we DID use for our sponsorship of Pack World’s NIA, click here! Do you like the photo?!? It’s ME!
Excerpt from the unpublished Truth about BPA & PVC
Please note: WordPress format does not allow me to include footnotes; please email me at cslavin@dordan.com for a list of references.
Nowhere has plastic become more omnipresent then in modern healthcare. Dutch physician Willem Kolff, motivated by assurance that “what God can grow, Man can make,” scrounged sheets of cellophane and other materials in Nazi occupied Holland to perfect his kidney-dialysis machine. Today,
Plastic pacemakers keep faulty hearts pumping, and synthetic veins and arteries keep blood flowing. We replace our worn-out hips and knees with plastic ones; and, plastic scaffolding is used to grow new skin and tissues. Plastics supply the essential everyday equipment of medicine, from bedpans to bandages to single use gloves and syringes. With plastics, hospitals could shift from equipment that had to be sterilized to blister-packed disposables, which improved in-house safety, significant lowered costs, and made it possible for more patients to be cared for at home.
While medicine is a small market when compared with plastics’ other applications, it has been revered as the industry’s golden child, showcasing the benefits of polymers. Such association between plastics and healthcare was done so, however, on the presumption that plastics were safe and chemically inert. As Modern Plastics pointed out in a 1951 article titled Why Doctors are Using More Plastics, “Any substance that comes into contact with human tissue…must be chemically inert and non-toxic, as well as compatible with human tissue and not absorbable.” But in the late 1960s and early 1970s, a sequence of findings began challenging this assumption of chemical stability.
PVC is one polymer used in healthcare for its presumed chemical stability. PVC has chlorine as one of its main components, a greenish gas that is derived from sodium chloride. To make PVC, the chlorine is mixed with hydrocarbons to form the monomer vinyl chloride, which is then polymerized, resulting in a fine white powder. “This unusual chemistry is PVC’s great strength, but also its greatest problem—the reason that industry sings its praises and that environmentalists call it Satan’s resin”: The chlorine base makes PVC chemically stable, fire resistant, waterproof and cheap (since less oil or gas is needed to produce the molecule); it also makes PVC dangerous to manufacture and hazardous to dispose of, because when incinerated it releases dioxins and furans, two carcinogenic compounds. PVC is also unusually “poly-amorous,” which means it tends to hook up with a variety of other chemicals, allowing it to be converted for an array of applications; without additives, PVC is so brittle it is basically useless. This versatility has made PVC one of the top-selling plastics in the world and a frequent choice for manufacturers of medical devices. Due to its dependence on additives, however, it has come under scrutiny.
Plasticized PVC is when the plastic is made soft and pliable through the addition of a clear, oily liquid called di (2-ethylhexyl) phthalate, or DEHP, a member of the phthalate family. Phthalates have become so ever-present in consumer and industrial products that manufacturers make nearly half a billion pounds of them each year; they’re used as plasticizers, lubricants, and solvents. While you’ll find phthalates in anything made of soft vinyl, they also exist in other types of materials, too. Examples include: food packaging and food processing equipment, construction materials, clothing, household furnishings, wallpaper, toys, personal-care products like cosmetics, shampoos and perfumes, adhesives, insecticides, waxes and inks, varnishes, lacquers, coatings, and paints. But our primary exposure to DEHP is through fatty foods such as cheese and oils, which are particularly likely to absorb the chemical, though it is unclear whether that is happening via plastic packaging, the inks used in food wrapping, or during commercial preparation and processing. There are about 25 different types of phthalates, but only about a half a dozen are widely used; of those, DEHP is one of the most popular, especially for medical devices.
In a 1969 experiment Johns Hopkins University toxicologists Robert Rubin and Rudolph Jaeger accidently discovered that DEHP was leaching out of PVC blood bags because DEHP is not atomically bonded to the molecular PVC daisy chain; therefore, can migrate out, especially in the presence of blood or fatty substances. Follow up studies found traces of DEHP in stored blood as well as in the tissues of people who had undergone blood transfusions. Thereafter, a chemist at the National Hearth and Lung Institute reported that he found residues of DEHP and other phthalates in blood samples taken from a sample population of one hundred people. Unlike the former findings, however, this population had not undergone extensive medical treatment; these people were simply the consumers of synthetic goods, those who may have been exposed to phthalates from any of thousands of everyday products, from cars to toys, wallpaper to writing. Today, at least 80% of Americans—of all ages, races and demographics—now carry measurable traces of DEHP and other phthalates in their bodies, according to biomonitoring studies by the Centers for Disease Control. Yet as the CDC has articulated, “the mere presence of DEHP in someone’s body does not mean it is a health hazard. The difficult question is whether the small amounts to which we are all exposed are significant to affect some people’s health." Plastics manufacturers had long known that additives could and would leach out of polymers but maintained that people weren’t exposed to high enough levels to suffer any harm. After taking a hard look at DEHP and other phthalates, independent toxicologists came to the conclusion that only at very high doses could DEHP/phthalates cause birth defects in rodents and induce liver cancer in rats and mice, but only through a mechanism that rarely affects humans. Hence, it was concluded that there was no cause for concern, based on the fundamental principle of modern toxicology that the dose makes the poison.
This assumption that the dose makes the poison was challenged, however, by mom- turned-zoologist Theo Colborn, who began developing a different theory of toxic effects based on her work in the late 1980s at the Conservation Foundation in Washington. Enlisted to research the effects of pesticides and synthetic chemicals on the Great Lakes wildlife, Colborn found “weird, eerie accounts of chicks wasting away, cormorants born with missing eyes and crossed bills, male gulls with female cells in their testes, and female gulls nesting together.” Sensing something lurking beneath the surface, Colborn created an electrical spreadsheet sorting the information by species and health effect and found that most symptoms could be traced to a dysfunction of the endocrine system—the network of glands that produces hormones and govern growth, development, metabolism and reproduction. Colborn discovered that adult animals exposed to chemical toxins were fine; the main health problems were found in their offspring. Colborn wrote, “Unlike typical toxins, these seemed to be acting as hand-me-down poisons.” Colborn’s findings suggested the possibility that wildlife and people were being exposed to a new kind of risk from widely used chemicals—this changed the assumption that the dose makes the poison—insofar as the poison wasn’t solely in the dose; it could also be in the timing of exposure. In July 1991 at the Wingspread Conference Center in Racine, Wisconsin, a group of members from a range of disciplines dubbed these trends “endocrine disruption,” which included three important findings often overlooked by traditional toxicological research: the effects could be transgenerational; they depend on the timing of the exposure; and they might come apparent only as the offspring developed. A discussion of endocrine-disrupting suspect bisphenol A will make clear the ambiguous effects of these compounds on the human body.
BPA is the primary component of polycarbonate, a hard, clear plastic that’s used in baby bottles, compact discs, eyeglass lenses, and water bottles; BPA is also a basic ingredient of epoxy resins used to line canned foods and drinks. Unfortunately, the bonds holding these long molecules together can be weakened fairly easily, allowing BPA to migrate out of the polymer daisy chain. Scientists have known since the 1930s that BPA acts as a weak estrogen, binding with estrogen receptors on cells and blocking natural stronger estrogens from communicating with cells. By now hundreds of studies have suggested BPA does just that in animals and humans, reporting the compound causes health effects in cells and animals that are similar to diseases becoming more common in people, such as: breast cancer, heart disease, type 2 diabetes, obesity, and neurobehavioral problems such as hyper activity. BPA research has been highly controversial because the alleged effects seen at very low doses don’t show up at higher doses; yet, it makes sense if you view the chemical as hormone rather than poison in which toxic effects increase with the amount of exposure.
Unlike most suspected endocrine disruptors like BPA that mimic estrogen, DEHP—the chemical found in PVC IV bags and tubing, not to mention a host of other vinyl items like shower curtains—is an antiandrogen, meaning it interferes with testosterone and other masculinizing hormones of both men and women. As observed in rat studies, once the chemical enters the body, it travels to the pituitary where it stops the production of a hormone that directs the testicles to make testosterone. It is believed that when this occurs during sensitive periods of development, testosterone levels can plummet and growth and development may be influenced. Epidemiologists have charted rising rates of male infertility, testicular cancer, and decreased testosterone levels and diminished sperm quality in many western countries, though the connection to DEHP is unknown. Such findings led an expert panel convened by the National Toxicology Program in 2006 to conclude that there were “grounds for concern that DEHP exposure can affect the reproductive development of baby boys under the age of one.”
While DEHP is thought to affect cells in the testes that secrete testosterone, such findings have not been observed in recent primary studies involving young marmosets, our closest relatives. Moreover, epidemiological findings on sperm quality have been inconsistent: some studies show correlations with phthalate levels, some don’t. These contradictions in DEHP/phthalate studies have led the American Chemistry Council to make the following critiques thereof: the sample size is too small; rats are poor models of human health hazards; the dose administered in animal studies are much higher than those experienced in humans; the demonstrative health qualities are not necessarily adverse. The continuing uncertainties are one reason why expert panels that have looked at these compound all come to the same conclusion: more and better studies are needed.
A few of the chemicals used in plastics—the phthalates found in IV bags, triclosan, an antibacterial found in kitchenware and toys, and the brominated fire retardants widely used in furniture—have already caught the attention of researchers and regulators. However, we have no coherent body of law for managing the chemicals we experience in daily life, which makes the regulation of suspected endocrine disruptors difficult. The EPA recently announced it would take steps to limit use of phthalates, including DEHP. The FDA, on the other hand, judges that the chemical offers more benefit than risk and therefore has ignored calls to limit its use in medical devices; its only action to date has been a 2002 advisory recommending that hospitals not use devices containing DEHP in women pregnant with boys, in young male infants, and in young teenage boys. This inconsistent approach to chemicals management is part and parcel of The Toxic Substance and Control Act (1976), which presents the following Catch-22: The EPA needs evidence of harm or exposure before they can require a chemical manufacturer to provide more information about a chemical, but without that information, how do they establish evidence of harm? In the absence of evidence, regulators cannot act. In Europe, law makers abide by the precautionary principle in which “the burden of proof is on safety rather than danger.” This allowed the EU to prohibit the use of DEHP in children’s toys in 1999, nine years before the US Congress pass similar legislation. A new directive known as REACH (Registration, Evaluation, and Authorization of Chemicals), adopted in 2007, requires testing of both newly introduced chemicals and those already in use, with the responsibility on manufacturers to demonstrate that they can be used safely.
SO, what do you think? Confusing, eh?
