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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
×
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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
×
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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
×
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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
×
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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
×
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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
×
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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
×
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Suggested Citation:"2 The Challenge: Chemicals in Today's Society." Institute of Medicine. 2014. Identifying and Reducing Environmental Health Risks of Chemicals in Our Society: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18710.
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2 The Challenge: Chemicals in Today’s Society To set the stage for the rest of the workshop, several presenters spoke about the challenge of chemicals in today’s society and general approaches to dealing with chemical risk. Lynn R. Goldman, Dean of the George Washington University School of Public Health and Former Assistant Administrator for Toxic Substances at the U.S. Environmental Protection Agency (EPA), began by offering some historical context. Twenty years ago she had joined the EPA, where she was responsible for the chemical and pesticide regulatory programs and the concerns then were very similar to those today. “Indeed, all of these topics that we have before us today were topics that were before the EPA at that time.” She noted that chemicals regulation is a very difficult and complex area but for years it has been clear that the EPA has been unable to make adequate progress under existing requirements. A fundamental notion in dealing with chemical hazards is risk, a concept that has been promulgated extensively by the National Academies, beginning with the 1983 publication Risk Assessment in the Federal Government: Managing the Process (NRC, 1983), known as the Red Book. The Red Book describes four steps for risk assessment: (1) hazard identification, (2) dose–response assessment, (3) exposure assessment, and (4) risk characterization. Goldman expanded on two of these components, hazard and exposure. Hazardousness is the ability of a chemical to actually cause harm at various dosage levels, Goldman said, while exposure is the amount of dose that might be received at target tissue after contact. Exposure may depend on various susceptibility factors such as age and stage of development, gender, genetics, nutrition, and comorbidities. “There are many individual issues that can cause variability in responses to chemicals,” she said. “That means, of course, that the availability of scientific information is fundamental to our ability to understand risk, and it is also fundamental to our ability to manage those risks.” 5

6 ENVIRONMENTAL HEALTH RISKS OF CHEMICALS THE CHALLENGE A good place to start in understanding the challenge facing the country is to get a sense of just how many chemicals are produced and used in society. To offer some historical context, Goldman quoted Paracelsus, the 16th-century Swiss-German physician, botanist, and alchemist who is credited with founding the science of toxicology. Listing the chemicals present in commerce nearly 500 years ago, Paracelsus wrote: What, then, shall we say about the receipts of Alchemy, and about the diversity of its vessels and instruments? These are furnaces, glasses, jars, waters, oils, limes, sulphurs, salts, salt-petres, alums, vitriols, chrysocollae, copper-greens, atraments, auri-pigments, fel vitri, ceruse, red earth, thucia, wax, lutum sapientiae, pounded glass, verdigris, soot, crocus of Mars, soap, crystal, arsenic, antimony, minium, elixir, lazarium, gold-leaf, salt-nitre, sal ammoniac, calamine stone, magnesia, bolus armenus, and many other things. Moreover, concerning preparations, putrefactions, digestions, probations, solutions, cementings, filtrations, reverberations, calcinations, graduations, recti- fications, amalgamations, purgations, etc., with these alchemical books are crammed. Then, again, concerning herbs, roots, seeds, woods, stones, animals worms, bone dust, snail shells, other shells, and pitch. (Paracelsus, 1531) “It was a fairly short list of chemicals,” Goldman noted. “They lived in a world where most human needs, material needs, were met by the natural world through wood, metals, and other resources that were extracted from the natural environment. Today, we live in a very different world, where nearly everything in this room is in some way derived from industrial chemicals.” The volume of chemicals in commerce increased a great deal during the 20th century, she noted. In just the 25 years between 1970 and 1995, the volume of synthetic organic chemicals produced tripled, from about 50 million tons to approximately 150 million tons (see Figure 2-1) (Goldman, 2002). And today it is much more, she noted.

THE CHALLENGE H : CHEEMICALS IN TOD DAY’S SOCIETY 7 FIGUR RE 2-1 Volum me of chemiccals in comm merce: U.S. syynthetic organnic chemiccal production, 1966–1994. SOURC CE: Adapted from Goldman n, 2002. Copyyright © 20022, Environmenntal nstitute®, Wash Law In hington, DC. Reprinted with ppermission. Riichard Denison, Senior Scientist S at tthe Environm mental Defennse Fund, also spoke ab bout the increease in chemmical use. “Cleearly, there hhas been a strong upwaard trend in just the sheer volume of cchemicals being producced,” he said.. According tot one estimaate, global salle of chemicaals has increased by a factor of about 25 since 1970, from $171 billion to $4.1 trrillion (UNEP P, 2013). Over the next few w decades, hee added, the raate of incrrease in the volume of ch hemicals usedd worldwide is expected to continue, or even accelerate (U UNEP, 20133), and it wiill dramaticallly outpacce the increasee in populatio on (see Figuree 2-2) (Wilsonn et al., 2008). Thhe other thingg that has ch hanged, Denisson said, is tthe diversity of use of o chemicals, especially in consum mer products and building materiials, with man nufactured sub bstances repllacing naturall materials. O One estimaate is that ch hemicals aree used in 966 percent off manufacturred materiials and produ ucts (ACC, 20 014). The Total Number of Chemicals C in n Commerce Today Gooldman noted d that given n the huge iincrease in tthe volume of chemiccals produced d in the United States annd worldwidee, an importaant questio on to ask is which w chemiccals are in usse and how m many are therre. This is an importaant starting point p for undderstanding thhe hazards thhat chemiccals might po ose to the envvironment andd human heallth. It turns ouut, howevver, that this is not an easy question to aanswer.

8 ENVIRONMENTAAL HEALTH RISK KS OF CHEMICA ALS FIGURRE 2-2 Projeccted growth in n worldwide chhemical produuction and globbal populattion through 20 050. SOURC CE: Wilson an nd Schwarzman n, 2009. Reprinnted with perm mission. Gooldman explaained that thee best availabble estimate ccomes from tthe EPA, which w was taasked by the Toxic T Substannces Control Act (TSCA) of 19761 with creating an invento ory of chemiccals being prroduced in thhis countrry. TSCA did not cover foo od and food aadditives, druggs, or cosmetiics (all of which are reggulated by the Food and Drrug Administrration), nor dooes it coveer firearms and a ammunitiion, pesticidees, tobacco, aand “mixturess,” although the compo onents of thoose things aree covered. Othherwise, TSC CA coverss pretty much all of the cheemical substaances produceed in the Unitted States.. Too create the initial chem micals inventoory, Goldmaan said, TSC CA requireed all manufafacturers and processors oof chemicals to report aboout those chemicals c to the EPA betw ween 1978 annd 1982. Durring that periood, the EP PA received reports on approximatelly 62,000 chhemicals (EPA, 2014).. Thhe law also reequired that, when w manufaccturing a new w substance thhat was not on the lisst, the manuffacturer had to bring it tto the EPA ffor revieww and to add itt to the invenntory using a pprocess establlished in TSC CA called Premanufactu ure Notificatioon (PMN). Chhemicals addeed via the PM MN processs are called “new chemiccals.” From 1982 and 20012, the agenncy added 22,000 new chemicals c to th he inventory. T Therefore, thee EPA inventoory 1 Toxicc Substances Control Act of 1976, 1 Public Laaw 94-469, 94th Congress.

THE CHALLENGE: CHEMICALS IN TODAY’S SOCIETY 9 now contains around 84,000 chemical substances that may possibly be in commerce (GAO, 2013). TSCA also established a process for the EPA to periodically obtain updates on the manufacture, import, and use of chemicals on the inventory; the EPA obtains these data via regulation. Initially, the EPA updated the inventory every 4 years—in 1986, 1990, 1994, 1998, 2002, and 2006. Those updates were not complete, Goldman said. First, small manufacturers were exempted from reporting if they were manufacturing less than 10,000 pounds of a substance at a single site during the time of a report. Second, inorganics, polymers, microorganisms, and naturally occurring chemicals were exempted. In 2006, exemptions were expanded when the exemption cutoff for small manufacturers was increased to 25,000 pounds per year at a single site at the time of the report, and petroleum process streams and certain forms of natural gas were exempted from reporting. At the same time, in 2006 some data collection was expanded through the phase-in of reporting of inorganics and new requirements to report on the use of chemicals and production data for the chemicals with the highest production volumes. In 2012 the EPA revised the regulation yet again, gradually lowering the volume thresholds for reporting to increase the total number of chemicals that must be reported. “In reality,” Goldman said, “we really don’t know how many chemicals are currently in commerce in the United States because the method of updating the inventory wasn’t designed to answer that question.” Instead, it was designed to inform us about chemicals that are produced at higher volumes. The maximum possible number is about 84,000 chemicals in commerce, she said, but many new chemicals actually never make it to the market even though they were put on the inventory. A company may choose not to bring a chemical to market for many reasons, and it does not report that to the EPA. Furthermore, there is no process for delisting existing chemicals that are no longer in commerce. The Society of Chemical Manufacturers and Affiliates reports that there are about 25,000 chemicals in commerce (SOCMA, 2014), but this is probably a minimum estimate, Goldman said. So there are somewhere between 25,000 and 84,000 chemicals in commerce in the United States. “That is a pretty wide range,” Goldman commented, and the uncertainty—in both the number of the chemicals and even the identities of which are in circulation—offers an indication of the problems that arise in trying to prioritize the various chemicals.

10 ENVIRONMENTAL HEALTH RISKS OF CHEMICALS The Changing Understanding of Chemical Exposures In addition to the growing number and volume of chemicals produced by society over the past several decades, Denison said, a second major change has been in our knowledge about how chemical exposures may occur. “The advent of biomonitoring during this period has shown that we all carry around hundreds of synthetic chemicals in our bodies,” he said. “Every time we look for more, we find more.” That realization has been combined with a growing understanding of how chemicals move though the environment—via both air and water and sometimes over quite long distances—and how chemicals that are used in products may make their way into human bodies. Denison offered two examples of how such movement from products into the environment and into people can occur. In recent years, he said, researchers have determined how the flame retardants used in furniture foam end up within people. “Every time you sit on an upholstered item, a little bit of dust puffs out,” he said, “and that dust includes those chemicals.” The dust can be either ingested or inhaled. “That is a pretty clearly established pathway for chemical exposure that we didn’t ever really think about, and certainly not several decades ago.” The second example involves coal tar–based sealants used on parking lots. The U.S. Geological Survey has tracked the sources of polycyclic aromatic hydrocarbons (PAHs) found in urban sediments and streams and discovered that a major source is contributed by runoff from parking lots treated with such sealants. The researchers have now extended that work, Denison said, and found that “in apartment buildings adjacent to parking lots that are treated with these sealants, people are literally tracking this material into their homes, and it is resulting in higher levels of PAHs in the house dust in those homes.” There has also been a growing realization in recent years that chemical exposures often affect different populations disproportionately— and that it is often those in lower socioeconomic brackets who suffer most. “That raises a lot of environmental justice concerns that we are much more cognizant of today,” he said. There have been various drivers for the growing concern over chemical exposures, Denison said. Medical science has shown, for example, that a number of specific chronic diseases are on the rise in the human population despite an overall trend of reduction in chronic disease. For instance, Denison noted that childhood cancers and leukemia are becoming more common (Ward et al., 2014), as are infertility and

THE CHALLENGE: CHEMICALS IN TODAY’S SOCIETY 11 other reproductive problems and learning and developmental disabilities (Safer Chemicals Healthy Families, 2012). Certain chemicals are being linked to these same chronic diseases, both from studies in laboratory animals and sometimes also from epidemiologic data. “Now, that is still a circumstantial case in many cases,” Denison said, “but it is increasingly one that is showing connections between those exposures and diseases and disorders that are rising in the human population faster than genetics or something like that could explain.” This in turn has led to a growing recognition of the various ways people may be susceptible to chemical exposures. Researchers now realize, for instance, that early-life exposures can have very significant effects, some of which can last a lifetime. And exposures to chemicals that mimic biologically active chemicals that are normally found in our bodies, such as hormones, can exert effects, especially early in development, and even at low doses. And there has been a growing understanding of how epigenetics may be a mediator for chemical and other environmental exposures that may also help explain some of the variability in susceptibility that has been observed. Epigenetics offers a basis for understanding how early-life exposures can lead to later-life health repercussions, including different disorders and diseases. It is even possible that epigenetics could lead to transgenerational effects, Denison said, although that is still a very controversial concept. The scientific approach to assessing risks has also changed dramatically in the past few decades, Denison said, particularly in the period between the 1983 publication of Risk Assessment in the Federal Government: Managing the Process, known as the Red Book (NRC, 1983), and the 2009 publication of Science and Decisions: Advancing Risk Assessment (NRC, 2009). “There are a lot of issues that are on the table now,” he said, “and part of that debate is how to better assess and take into account human variability.” Researchers are increasingly recognizing the presence of such variability in the human population, both from genetic variations and from other differences, such as variations in nutrition, health, and ways of living. Denison explained that this variability raises questions about how one deals with the uncertainty associated with identifying a level of concern for a chemical. How much variability is there, for example, in the dose response to various chemicals? Does it still make sense to consider that there are thresholds below which there is no effect? Even if a threshold has been established in a laboratory setting, Denison asked,

12 ENVIRONMENTAL HEALTH RISKS OF CHEMICALS does it still make sense to talk about such a threshold in a variable human population, “especially in light of cumulative effects and the fact that we are being exposed to multiple chemicals and other types of stressors?” Another change that occurred over the past several decades is the appearance of a variety of new technologies that can be used to assess chemical hazards and exposures. For example, he said, the emerging high-throughput testing in both in vitro and in vivo settings has the potential to • address the huge backlog of untested chemicals, • increase human relevance, • identify biomarkers of exposure to specific chemicals, • consider multiple cell types and life stages, • test at many different doses, • assess mixtures, and • inform green chemistry. There will also be many challenges to putting such new technologies to work, Denison said. How, for example, do we move from an in vitro set of assays to understanding the full implication in a whole organism? Can all potential effects pathways ever be captured? And how do we account for the way exposures take place in the real world, with multiple exposures at different times and chronic exposures? THE PUBLIC HEALTH APPROACH TO INDUSTRIAL CHEMICAL ASSESSMENTS Given the presence of so many chemicals that humans may be exposed to, a natural question is how best to ensure human health in the face of these chemicals. William E. Halperin, Chair of the Department of Preventive Medicine at the New Jersey Medical School, described how the field of public health approaches industrial chemicals and industrial chemical assessment. There is actually no single “public health approach,” Halperin said. Instead, public health resembles the proverbial elephant examined by a group of blind men—it can seem to be a rope (the tail), a wall (the side), a pillar (the leg), a tree branch (the trunk), a fan (the ear), and so on, depending on exactly which part is being examined. So, Halperin said, he would illustrate the public health approach to chemicals by describing five different paradigms that could be used in dealing with such chemicals:

THE CHALLENGE: CHEMICALS IN TODAY’S SOCIETY 13 the industrial hygiene approach, prevention, surveillance, embeddedness, and dose response. The first paradigm—the traditional public health approach—is one of anticipation, recognition, evaluation, intervention, and effectiveness. “This is what is taught in industrial hygiene,” Halperin said. Anticipation is easy to understand, he said: If you combine a micro-car, a teenage driver, and high speed on a highway, you have to anticipate the problem that you are going to run into. Sometimes it is not possible to anticipate an issue; in those cases one must recognize it when it appears. Halperin mentioned the case of Ramazzini, who was quoted in about 1710 saying something to the effect of, “I have never visited a nunnery that has escaped the scourges of breast cancer. There must be a connection between the breast and the uterus which escapes the detection of the prossectors [i.e., dissectors].” Ramazzini, who is considered the father of occupational medicine, invented occupational epidemiology in that observation that delayed childbirth put a woman at greater risk of certain adverse effects. Although it was not possible at the time to explain Ramazzini’s observation, still it was a classic example of recognition. Evaluation is somewhat different from recognition. To illustrate, Halperin pointed out that there have been many toxicological studies showing that TCDD (2,3,7,8-tetrachlorodibenzodioxin) is associated with adverse effects. That was recognition. “The evaluation came in the 1980s with NIOSH [the National Institute for Occupational Safety and Health] doing a cohort mortality study of about 6,000 workers highly exposed to dioxin in various occupational situations,” which made it possible to then identify the adverse effects associated with TCDD exposure. Intervention is a product of education, engineering, and regulation, he said, and effectiveness refers to the process of observing whether the steps taken during the intervention were actually effective. “This is the industrial hygiene approach. It is a good broad approach that helps us work on issues of recognition and of hazards.” To illustrate the other paradigms he would be talking about, Halperin began with an anecdote concerning ortho-toluidine, an organic compound used in the production of dyes. Aniline-based dyes such as benzidine have long been known to be carcinogenic. In the 1970s, Halperin said, bioassays suggested that toluidine was actually much more carcinogenic than aniline and that toluidine was associated with bladder cancer in animals. Furthermore, there were a few studies in the 1970s

14 ENVIRONMENTAL HEALTH RISKS OF CHEMICALS that demonstrated that aniline was not associated with bladder cancer, but that mixed exposures of the aniline-based dyes were. There were two different groups exposed to toluidine. The first consisted of workers exposed to the chemical in the workplace; the National Occupational Survey in the early 1980s estimated that about 30,000 workers received this occupational exposure. The second group consists of those people exposed to the toluidine found in cigarette smoke, which amounted to tens of millions of people whose exposure was at a much lower level than the workers. Given these occupational and environmental exposures to something that was a known carcinogen in animal studies, there was a reasonable expectation that there would be a resulting health effect. “That brings us to 1988 when Steve Markowitz, who was an occupational physician working with the Oil, Chemical, and Atomic Workers Union, visited a plant in upstate New York to give a general talk on occupational health,” Halperin said. “Workers approached him and asked, Is it meaningful that seven of our cohort have bladder cancer?” The result was that NIOSH was brought in to perform a hazard evaluation. “I was there,” Halperin said. “I was on the walk-through.” The NIOSH team found signs warning of a suspected carcinogen. “There were literally signs saying there was a suspected carcinogen and that there may well be a problem associated with this plant.” The team found out that the suspected carcinogen was toluidine. After performing an incidence study, the team found that people who had been exposed for 10 years had a risk of developing bladder cancer that was 30 times greater than the general population. There really was a problem. The effect of all of this work was that ortho-toluidine is now accepted as carcinogenic. And this, Halperin said, is in reality the way that public health has traditionally approached chemicals. The approach is reactive. “We react to observations by astute observers, whether it is Ramazzini or a group of workers at a chemical plant in northern New York State, that there is a problem. We react rather than systematically investigate.” With that example as a touchstone, Halperin described the four other paradigms. The second is the preventive medicine approach, which can be thought of as consisting of primary, secondary, and tertiary prevention. Primary prevention refers to action taken before there is an exposure, he explained. “It is premarket testing so that something doesn’t ever get to

THE CHALLENGE: CHEMICALS IN TODAY’S SOCIETY 15 the workplace. It is substitution or elimination. It is environmental controls. It is personal protective devices. It is all of those kinds of things.” Secondary prevention refers solely to routine periodic screening with the goal of detecting a disease early while it is easier to treat. And tertiary prevention refers to the range of medical care and health care used to respond to a disease once it appears, from drug treatments and surgery to rehabilitation and accommodation. Tertiary prevention has grown immensely in importance over the past 10 years, Halperin said, largely because of the observations of the Institute of Medicine about the number of people who die because of lack of medical care (IOM, 2002, 2003). In the example of ortho-toluidine, primary prevention would include such things as premarket testing, substitution or elimination, environmental monitoring, environmental controls, and biologic monitoring. “All of this falls in the area, if you will, of toxicologists talking to industrial hygienists,” he said. An example of secondary prevention related to toluidine would be screening cytoscopy, and tertiary prevention could include surgery, compensation, and accommodation. The series of actions in preventive medicine can be thought of in terms of a cascade (see Figure 2-3). “This is how we operate in the industrial setting to reduce adverse effects,” Halperin said. “We try our best at these [primary] levels up here. Often times we only find out that there is a problem down here [in the tertiary levels] when there is clinical care made available to seven workers who have bladder cancer.” The third paradigm, surveillance, was fathered by Alex Langmuir at the Centers for Disease Control in the 1950s, although historically it goes back to the 18th and 19th centuries, Halperin said. It is “the systematic, ongoing collection of relevant health-related data—disease, injury, hazard, intervention, etc.—and their constant evaluation and dissemination to all who need to know for the purpose of prevention.” A crucial related concept is the idea of a “sentinel health event.” This is a paradigm that was developed at NIOSH in the 1980s, he said. A sentinel health event is “an unnecessary disease or injury, disability, or untimely death which is known to be preventable and whose occurrence serves as a warning signal that preventive or medical care may need to be improved.” A closely related hazard, such as a high rate of lead exposure or a low rate of immunization, may also serve in place of a disease or an injury.

16 ENVIRONMENTAAL HEALTH RISK KS OF CHEMICA ALS FIGUR RE 2-3 Cascadde of prevention n: Hierarchy oof controls. SOURC CE: Halperin, 2013. Suurveillance seerves, in essence, as a ffeedback mecchanism in tthe cascadde of preventio on (see Figuree 2-4). It is noot done to reduuce exposure or to ameeliorate sympttoms directly. Instead, it seerves to provide information concerrning what is going on and d thus to inforrm various prreventive stepps, Halperrin explained d. “Okay, theere are sevenn cases of blaadder cancer— — what does d that meaan when we go back to tthe design off the operatioon? What does it meaan to how we w ought to ttake care off environmenttal monito oring? Should d we be protecting workerss better from the exposure??” Thhe fourth paraadigm, “embeddedness,” refers to the fact that all of the varrious actions taken to detect and responnd to health isssues take plaace in a laarger context. “It is all imb bedded in an economics, ssocial, political, regulatory, and eth hical matrix,” Halperin saiid. “We all hhave to work in this matrix.” Thhe fifth paradigm is reesponding too risk throuugh preventiive mediciine, which Halperin H said could be traaced to a boook by Geoffrrey Rose, The Strategyy of Preventivve Medicine ((Rose, 1992).. Rose calls ffor reducing risk throughout an entiire populationn rather than ffocusing on tthe small percentage p off people within a populatioon who are m most affected bby a partiicular risk. Haalperin illustrrated the idea with a pair oof diagrams thhat could refer r ge number of situations (seee Figure 2-5)). to a larg

THE CHALLENGE H : CHEEMICALS IN TOD DAY’S SOCIETY 17 FIGUR RE 2-4 Cascadde of prevention n with feedbacck from surveilllance added. SOURC CE: Halperin, 2013. Thhe graphs cou uld represent a number off things, he eexplained. Thhey could represent th he distributio on of systollic blood prressure in tthe populaation, for exam mple, or the population p exxposure to tolluidine. In eaach case thhere is a group (represented by the hatchhed region too the far right in Figuree 2-5a) that iss most at risk and that getss most of the attention in tthe traditioonal clinical approaches.. “We set a bright linee, and we call everyb body to the right r of it a hypertensivee. We see thhem every tw wo month hs, and these other people [to the left oof the line] w we reassure annd tell theem to go homme. The same is i true if you think about ttoluidine.” What W Rose pro oposed was not n only to takke care of thhe people at tthe highesst exposure, but b to shift th he populationn to the left, aas illustrated in Figuree 2-5b. The id dea is to reduce exposuree for everyboody, which w will have a greater efffect than sim mply workingg with those people at tthe highesst level of expposure. Thhis approach has been sho own to work w with hypertennsion, Halperrin said. Although A thosse people withh the highest blood pressuures are most at risk off heart attack n increased rrisk of heart attack in thoose ks, there is an with somewhat ellevated bloo od pressures,, and becauuse those wiith

18 ENVIRONMENTAAL HEALTH RISK KS OF CHEMICA ALS moderrate levels of hypertension h make up a m much larger peercentage of tthe populaation, they acccount for a laarge percentaage of the oveerall population risk fo or heart attackk. Those withh blood presssures over, saay, 180 actuallly accounnt for a relatiively small percentage p off the total poppulation effect, Halperrin said. Sommething similaar is true for cchemical riskks, such as wiith toluidiine. In this case there were some 30,0000 workers with very high occupaational expossure, but theree were tens oof millions off people withh a much lower—but still hazard dous—exposuure due to smoking. B By reducing exposure for everyon ne—shifting the curve too the left—tthe prevenntive strategy y seeks to have a greeater overalll reduction in populaation risk thaan would be achieved by focusing onn those most at risk. a Healtth Indicator Populaation Frequency b Healtth Indicator Population Frequenccy FIGURRE 2-5 Respo onding to risk: (a) traditionaal approach annd (b) preventiive medicin ne. SOURC CE: Adapted from fr Halperin, 2013.

THE CHALLENGE: CHEMICALS IN TODAY’S SOCIETY 19 NATIONAL CONVERSATION ON PUBLIC HEALTH AND CHEMICAL EXPOSURES In June 2009 the Centers for Disease Control and Prevention (CDC) along with the Agency for Toxic Substances and Disease Registry (ATSDR) launched the National Conversation on Public Health and Chemical Exposures. The project, which was designed to gather input from a diverse collection of public and private interests, had as its goal the development of ways to ensure that chemicals are used and managed in ways that are safe and healthy for all people. Nsedu Obot Witherspoon, Executive Director of the Children’s Environmental Health Network, served as co-chair of the project’s leadership council, and she described the National Conversation effort and the Action Agenda it produced to the workshop audience. The underlying rationale behind the project, Witherspoon said, was that the landscape regarding chemicals in the environment had changed considerably over the previous few years. There had been a growing recognition that there are many different exposure pathways, for example, as well as a recognition that chemicals can lead to a broad range of health outcomes. Biomonitoring had become feasible, and new approaches to toxicity testing had appeared. There had also been movement in the areas of environmental justice, green chemistry, and social media and communications. Thus, it was important to discuss how to effectively proceed in this changed landscape. As noted, the vision behind the project was to see that chemicals are used and managed in ways that are safe and healthy for all people. Accomplishing that vision would require a number of things, Witherspoon said. It would require accurate information and improved scientific understanding, better policies and practices, and improved prevention, preparedness, and response. It would demand the elimination of inequities and increased engagement by the public and by health care providers. And it would require the development of networks for collaboration and coordination. “We saw this as an opportunity to leverage the work already being done,” she said. “This was not at all intended to be a new aspect of work to reduce or eliminate chemical exposures, but rather to leverage and increase partnerships and opportunities, especially during these hard economic times.” A wide variety of partners were involved in the effort. CDC and ATSDR supported the National Conversation initially, and then they worked with a number of organizations to help manage the process.

20 ENVIRONMENTAL HEALTH RISKS OF CHEMICALS Resolve, which is an independent, nonprofit facilitator, convened and facilitated the National Conversation leadership council and a number of work groups. “To ensure strong engagement and input from environmental and public health stakeholders and the public, CDC partnered with the American Public Health Association, the National Association of County and City Health Officials, the National Association of State and Territorial Health Officials, and the National Environmental Health Association,” Witherspoon said. “Also, Westast’s Web dialogue group provided interactive online discussions at key points throughout the project.” The National Conversation had a leadership council and six work groups—on policies and practices, monitoring, serving communities, scientific understanding, education and communication, and chemical emergencies. Witherspoon explained that, during the 2-year process, thousands of members of the public participated through online and in- person forums. The work groups released detailed reports in October 2010. The 40-member leadership council issued the final Action Agenda in July 2011 (National Conversation on Public Health and Chemical Exposures, 2011).2 There was a major effort to make sure that the National Conversation included a broad set of perspectives. The leadership council and work groups included representatives from 13 federal agencies, with state, local, and tribal government agencies; national nongovernmental organizations; community and environmental justice groups; academia; industry; and affected communities. “Members of the public participated in over 52 community conversations held across the country and two Web-based dialogues,” Witherspoon said. “The leadership council drew heavily from the work group reports and public input in developing the Action Agenda.” The project’s main product was an Action Agenda that was intended to offer clear, achievable recommendations that could help government agencies and other actors and organizations strengthen their efforts to protect the public health from harmful chemical exposures. The Action Agenda was divided into seven chapters, each focused on a single priority topic: prevention, monitoring, science, communities, public engagement, health professionals, and emergencies. Each chapter describes the relevant 2 Further information about the National Conversation on Public Health and Chemical Exposures and the final report, Addressing Public Health and Chemical Exposures: An Action Agenda, are available at http://www.national conversation.us (accessed March 31, 2014).

THE CHALLENGE: CHEMICALS IN TODAY’S SOCIETY 21 public health problem, the challenges to resolving that problem, and the opportunities for new directions. It then offers several featured recommend- ations, along with additional recommendations related to that topic. In total, the Action Agenda offers 19 featured recommendations and 29 additional recommendations. For the remainder of her presentation, Witherspoon focused on the key issues and recommend-ations found in two chapters, Chapter 1 on prevention and Chapter 3 on science. Chapter 1 is titled “Protecting Public Health by Preventing Harmful Chemical Exposures.” It notes that although public health has traditionally emphasized primary prevention—the elimination or reduction of the causes of health problems—this has not typically been the approach taken in the United States regarding exposure to chemicals, and it concludes that, by not focusing on primary prevention, the country is missing opportunities to protect the public from harmful chemical exposures, said Witherspoon. To improve the situation, the chapter offers several featured recommendations. She noted that it calls on government agencies to prioritize the reduction of exposure to harmful chemicals. All levels of government are encouraged to provide policy incentives, to invest in research and development, to develop enhanced hazard screening methods, and to disseminate information for personal decision making. The chapter also calls on Congress to reform TSCA and encourages states to enact similar legislation. And indeed, Witherspoon said, such actions have been taking place at the state level for many years now. California, Maine, Massachusetts, Minnesota, and Washington have all implemented toxics use reduction legislation and initiatives. At the federal level there have been various efforts to reform TSCA, although none has yet come to pass. Another featured recommendation in the chapter is to make improved protection of children’s health a priority. Witherspoon noted that government agencies are asked to require explicit consideration of children’s unique vulnerabilities, susceptibilities, exposures, and develop- mental stages as well as of the places where children, live, learn, and play. Chapter 1 also has several additional recommendations, explained Witherspoon. They call for increasing the emphasis on public health principles and precaution; developing standard scientific criteria and protocols for applying a precautionary approach to chemicals; strengthening protections of workers’ health; ensuring that industrial and federal facilities comply

22 ENVIRONMENTAL HEALTH RISKS OF CHEMICALS with environmental health regulations, laws, and policies; and developing an overarching paradigm for assessing risk. Chapter 3, which is titled “Achieving a More Complete Scientific Understanding of Chemicals and Their Health Effects,” concerns the importance of knowledge and understanding concerning chemical toxicity, modes of action, sources of exposures, and potential adverse health effects. The United States has undertaken significant research efforts, Witherspoon said, yet we lack critical information on the health effects of chemicals, including low-dose, multiple, and cumulative exposures; on individual susceptibility and intolerance including, but not limited to the interplay between genes and environment; on community vulnerability and disproportionate effects from past exposures; and on the effectiveness of interventions to protect public health. The featured recommendations in Chapter 3 are aimed at enhancing scientific methods, tools, and knowledge. They encourage the expanded use, further development, and validation of modern molecular biology techniques, computational systems biology, and other novel approaches, said Witherspoon. Government agencies are encouraged to identify the data needed to fill gaps in the scientific understanding of health risks of chemicals and also to prioritize chemicals of concern for further assessment of exposures and safer alternatives. The enhancements that the EPA made to its Integrated Risk Information System (IRIS) in summer 2013 are just one example of recent actions consistent with Chapter 3’s recommendations, Witherspoon said. “The recent IRIS enhancements are intended to improve the scientific foundation of assessments, increase transparency in the program and the process, and allow the agency to produce more IRIS assessments each year. Standard protocols and tools to characterize human exposures across the life cycle of chemical products and across human life stages are also prioritized.” Chapter 3 has five additional recommendations as well, explained Witherspoon. They address coordinating and improving accessibility of databases, understanding individual susceptibility to chemical exposures, defining gene–environment interactions related to chemical and environmental exposures and social and lifestyle factors, identifying the health impacts of indoor air quality during fetal and child development, and evaluating ATSDR’s scientific methods. In the 2.5 years between the release of the report and the workshop, there were a number of examples of agencies acting in ways that were consistent with the report’s recommendations, Witherspoon said. For

THE CHALLENGE: CHEMICALS IN TODAY’S SOCIETY 23 example, the National Center for Environmental Health at CDC convened a workshop to examine ATSDR’s scientific approaches, which reflected Recommendation 3.8. And in the chapter on communities, it was recommended that the ATSDR be more focused on community concerns. “Since then,” Witherspoon said, “they have been creating geographic branches to ensure that all work is happening in a particular area and is more coordinated and also moving staff from their ATSDR headquarters to more of the local community levels and hiring more staff in the regions.” In June 2012, she said, the National Conversation Network was formed with the intention of encouraging further progress toward implementing the report’s recommendations and identifying opportunities for collaboration. Furthermore, the Environment Section of the American Public Health Association has a work group specifically organized around the Action Agenda. In particular, she added, there seems to be a great deal of interest right now in including environmental considerations into undergraduate, graduate, and health professional curriculum development and training. In addition, the call for TSCA reform is “resonating very loud and clear.” In conclusion, Witherspoon said that the National Conversation’s Action Agenda offers an effective roadmap for leveraging current partnerships and dealing with the lack of resources available. “This is a great time for us to take a step back to take an assessment of some aspects and initiatives that haven’t been so effective and think about re- routing ourselves,” she said. “This is a roadmap that I encourage all of us to spend some time reviewing and acting on.” REFERENCES ACC (American Chemistry Council). 2014. U.S. chemical production expanded in December: 2013 ends on a high note. Available at http://www.american chemistry.com/Media/PressReleasesTranscripts/ACC-news-releases/US- Chemical-Production-Expanded-in-December-2013-Ends-on-a-High-Note.html (accessed March 30, 2014). EPA (U.S. Environmental Protection Agency). 2014. TSCA chemical substance inventory: Basic information. Available at http://www.epa.gov/oppt/existing chemicals/pubs/tscainventory/basic.html (accessed March 30, 2014). GAO (U.S. Government Accountability Office). 2013. Toxic substances: EPA has increased efforts to assess and control chemicals but could strengthen its approach. Washington, DC: GAO.

24 ENVIRONMENTAL HEALTH RISKS OF CHEMICALS Goldman, L. R. 2002. Chapter 17: Toxic chemicals and pesticides. In Stumbling toward sustainability, edited by J. C. Dernbach. Washington, DC: Environmental Law Institute. Halperin, W. E. 2013. Public Health Approach to Industrial Chemical Assessments: 5 Paradigms. Presentation at the Institute of Medicine Workshop on the Identifying and Reducing Environmental Health Risks of Chemicals in Our Society, Washington, DC. IOM (Institute of Medicine). 2002. Care without coverage: Too little, too late. Washington, DC: National Academy Press. IOM. 2003. Hidden cost, value lost: Uninsurance in America. Washington, DC: The National Academies Press. National Conversation on Public Health and Chemical Exposures. 2011. Addressing public health and chemical exposures: An action agenda. Atlanta, GA: Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry. NRC (National Research Council). 1983. Risk assessment in the federal government: Managing the process. Washington, DC: National Academy Press. NRC. 2009. Science and decisions: Advancing risk assessment. Washington, DC: The National Academies Press. Paracelsus. 1531. Preface to the Coelum Philosophorum. Rose, G. 1992. The strategy of preventive medicine. Oxford: Oxford University Press. Safer Chemicals Healthy Families. 2012. Chemicals and our health: Why recent science is a call to action. Available at http://saferchemicals.org/PDF/ chemicals-and-our-health-july-2012.pdf (accessed March 30, 2014). SOCMA (Society of Chemical Manufacturers and Affiliates). 2014. Myth versus fact about chemicals in commerce. Available at http://www.socma.com/ GovernmentRelations/index.cfm?subSec=26&articleID=3259 (accessed March 30, 2014). UNEP (United Nations Environment Programme). 2013. Global chemicals outlook: Towards sound management of chemicals. Geneva: UNEP. Ward, E., C. DeSantis, A. Robbins, B. Kohler, and A. Jemal. 2014. Childhood and adolescent cancer statistics, 2014. CA Cancer Journal for Clinicians 64(2):83–103. Wilson, M. P., M. R. Schwarzman, T. F. Malloy, E. W. Fanning, and P. J. Sinsheimer. 2008. Green chemistry: Cornerstone to a sustainable California. Berkley, CA: Centers for Occupational and Environmental Health, University of California.

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On November 7-8, 2013, the Institute of Medicine's Roundtable on Environmental Health Sciences, Research, and Medicine held a workshop to discuss approaches related to identifying and reducing potential environmental public health risks to new and existing industrial chemicals present in society. Industrial chemicals include chemicals used in industrial processes or commercial products, not including those found in food, pesticides, or pharmaceuticals.

Identifying and Reducing Environmental Health Risks of Chemicals in Our Society is a summary and synthesis of the presentations and discussions that took place during the two days of the workshop. The workshop examined successes and areas for improvement within current regulatory programs for assessing industrial chemical safety, frameworks for chemical prioritization to inform targeted testing and risk management strategies, concepts of sustainability and green chemistry that support the design and use of safer alternatives, and efforts to reduce the risk of chemicals in our society.

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