Bottled Water Regulation
September 4, 2008 by Angela Logomasini, Ph.D.
Filed under Facts
Bottled water regulation is at least as stringent as tap water regulation. Yet a key line of attack against bottled water comes from environmental activists and others who complain that bottled water does not comply with the EPA standards for tap water, suggesting that bottled water standards are lower. As a result, they say, bottled water quality may not even be as good a tap water quality. These arguments were outlined in the “study” released by the Natural Resources Defense Council in 1999. However, such arguments don’t mesh with reality.
The EPA sets standards for tap water under the Safe Drinking Water Act (SDWA) and the Food and Drug Administration (FDA) sets standards for bottled water under the Federal Food, Drug, and Cosmetic Act (FFDCA). The FDA regulations are based on EPA standards and are mostly the same, with the exception of a few areas where tap water regulations don’t make sense or where the FDA includes additional or more stringent requirements. According to the EPA, both sets of standards produce bottled and tap water that is safe.
Under the SDWA, the EPA regulates more than 80 drinking water contaminants that might be found in the water of public water systems. For each regulated contaminant, the EPA usually specifies a maximum contaminant level goal (MCLG), which represents the level of a contaminant that the EPA ideally wants to allow in drinking water. The EPA uses the MCLG as a guide in setting the enforceable standard, the maximum contaminant level (MCL). The MCL represents the amount of that contaminant that systems may legally allow in tap water. For example, the EPA allows systems to provide only drinking water that contains no more than 0.005 milligrams of benzene per liter of water. When the EPA determines that it is technically or economically infeasible to monitor for a contaminant, it is directed by Congress to promulgate mandatory “treatment techniques,” such as mandatory installation of filtration devices.
The FFDCA requires that the FDA apply SDWA standards to the extent they make sense for bottled water. Its version of an MCL is a Standard of Quality (SOQ). And according to the FFDCA, SOQs must be “no less stringent” than EPA MCLs and “no less protective” than EPA treatment techniques. In other words, the FDA has two choices when setting a regulation. It must either be equivalent to EPA standards or it must be more stringent. The law does not allow the FDA to set standards that produce a lower quality product.
When deciding on an SOQ, the FDA must review EPA regulations for tap water once the EPA finalizes or revises them to assess whether they are applicable to bottled water. If the FDA finds that the tap water regulations are applicable, it must propose those same regulations for bottled water within 180 days after the EPA issues the tap water standards. The SDWA of 1996 demands that if the FDA fails to act, the EPA tap water regulations become the standards for bottled water. As a result, the FDA has overwhelmingly applied the EPA’s tap water standards to bottled water. [See Appendix A at the end of this document; It offers a comparison of FDA and EPA standards. Like the EPA, the FDA requires that the water be tested regularly to ensure that standards are met.
There are some cases where the standards vary because of differences between delivery systems. Since tap water travels through pipes, regulations need to address potential contamination from pipes. Sanitary packaging for bottled water means that regulations related to food and food packaging apply to bottled water.
FDA regulations are more stringent for some chemicals, including regulations of lead, copper, fluoride, and phenols. Henry Kim, Ph.D., a supervisory chemist at the FDA’s Center for Food Safety and Applied Nutrition, Office of Plant and Dairy Foods and Beverages points out the difference between regulations for lead in both tap and bottled water. He notes that EPA standards tolerate a higher level of lead than FDA standards for bottled water, because lead can leach from the pipes into water before it reaches the tap, making it more difficult to control. The EPA requires that tap water contain no more than 15 parts per billion of lead, while the FDA standard is much more stringent at 5 parts per billion. The FDA opts for a more stringent standard simply because it is more readily attainable for bottled water.
Some tap water regulations don’t apply to bottled water because the issues they address deal with tap water purification issues and pipe delivery. For example, the EPA regulates two substances—acrylamide and epichlorohydrin—simply because they are used in tap water treatment plants and can enter the water there. But these substances are not used to purify or package bottled water and hence are not an issue and do not warrant FDA regulation. The FDA also does not have a regulation for asbestos because they are not a problem in bottled water sources. The EPA regulates asbestos because it is used in cement pipes that distribute tap water. The FDA does not employ the EPA regulation for phthalates because the FDA applies standards related to food additives to ensure that such chemicals remain at levels below health concerns. Moreover, most bottled water comes in Polyethylene terephthalate (PETE or PET) plastic containers, which do not contain phthalates. The FDA does not apply EPA’s Enhanced Surface Water Treatment Rule since it applies to surface water. Bottled water typically comes from underground sources or from tap water that has already complied with the surface water rule.
When it comes to managing microbiological agents, FDA regulations vary from the EPA’s, but again, they must be “no less protective.” Instead of mandating specific filtration or disinfection methods, FDA mandates that water meet the same standards as all food products. These include sanitary production and packaging regulations as well as rules to ensure products are not “adulterated” with any harmful substance. In other words, the FDA regulates the final product and gives bottled water companies some leeway in how they reach that level of quality. The FDA explains:
“These regulations require that bottled water be safe and that it be processed, bottled, held and transported under sanitary conditions. Processing practices addressed in the CGMP regulations include protection of the water source from contamination, sanitation at the bottling facility, quality control to assure the bacteriological and chemical safety of the water, and sampling and testing of source water and the final product for microbiological, chemical, and radiological contaminants. Bottlers are required to maintain source approval and testing records to show to government inspectors. Checking adherence to part 129 regulations is an important part of FDA inspections of bottled water plants.”
Essentially, this means that when companies bottle water, the product must not present any human health threat, and the company must be able to demonstrate that fact to the FDA inspectors or face enforcement penalties. Specifically, regulations demand that bottled water not be adulterated any “deleterious substance that may be injurious to health,” which includes additives from the containers that might enter the water in trace amounts.
There are many good reasons why the FDA takes this approach. In particular, one of the qualities that many consumers like about bottled water is that many kinds come from natural sources and are not subject to the types of treatment techniques—such as chlorination—that affect the flavor of the product. And chlorination is not necessary for bottled water as it is for tap water, because bottled water is not delivered to the consumer via pipes, where it can become contaminated. Sanitary packaging essentially performs the role that chlorine does during pipe transport to consumers. Moreover, much bottled water comes from groundwater sources, which according to the EPA, is less likely to become contaminated, and hence does not require the same kind of disinfection. According to the EPA, “Ozone is preferred by bottlers, though it is more expensive than chlorine, because it does not leave a taste and because bottlers do not need to worry about maintaining disinfectant in water sealed in a container. Untreated water, whether from a bottle or from a tap, will have the characteristic taste of its source.” The International Bottled Water Association reports that its members provide 85 percent of the bottled water in the United States. Membership demands that companies employ a multi-barrier approach which may include steps such as source protection, source monitoring, reverse osmosis, micron filtration, distillation, ozonation and final disinfection.” Consumers can contact companies to learn about disinfection techniques before selecting a brand if the information does not already appear on the label.
Information found on the label is also regulated by the FDA. Labeling regulations demand that bottled water labels contain only accurate information. Products that don’t meet FDA standards are considered “misbranded.” Regulatory definitions for specific terms—“ground water,” “mineral water,” “purified water,” “sparkling water”—are all defined in FDA regulations (See Table I in this FDA document).
Bottled water providers must also meet “Good Manufacturing Practices.” Under these regulations, source water must come from an approved source that meets all the laws and regulations of the government that has jurisdiction of the water source. Good manufacturing practices also include regulations on processing, packaging, transport, and storage to ensure sanitary conditions. They also mandate that bottled water companies regularly monitor the water source and final products to ensure they comply with safety regulations. Other regulations involve specific identity and quality requirements for bottled water.
Nonetheless, some environmental activists have suggested that bottled water is of a lower quality because FDA only regulates water in “interstate commerce.” They suggest that a large share of bottled water is produced solely intrastate and hence they lead the public to believe that such water must be of a lower quality because it does not fall under FDA jurisdiction. For example, a Natural Resources Defense Council activist suggested in congressional testimony that as much as 40 percent of bottled water isn’t covered by FDA regulations. The figure appears to be the result of pure, but even if this claim were correct, it should not be at all alarming. In addition to the fact that states regulate bottled water to ensure safety, bottled water has a tremendous safety record, with very few problems reported. The next section of this paper compares that record to tap water and finds that there have been far fewer health-related problems associated with bottled water.
In any case, the idea that bottled water providers produce water that is lower quality than demanded by FDA is highly unlikely. In fact, the data in NRDC’s own report on bottled water shows that an overwhelming majority of bottled water meets or exceeds federal water standards. According to NRDC it “commissioned independent lab testing of more than 1,000 bottles of 103 types of bottled water from many parts of the country.” NRDC reports that only “four waters” failed (two exceeded standards for fluoride and two for coliform bacteria) to meet federal standards. The NRDC claims that this amounts to 4 percent failure rate, which indicates a success rate of upwards of 96 percent. That is an impressive record.
Moreover, given the broad definition of interstate commerce, it is unlikely that anyone could make a legal case that any bottled water doesn’t fall under FDA’s jurisdiction. In fact, “interstate commerce” covers most all commercial activity. For example in Wickard v. Filburn, wheat grown in a farm and consumed on a farm is considered to be part of interstate commerce because interstate commerce is affected because the farmer does not have to buy wheat in the marketplace. In Gonzales v. Raich, marijuana grown in a home for medicinal use under California law was considered interstate commerce and subject to federal law as well. In addition, if any part of a food product or packaging involves accessing materials that are produced or affect interstate, the produce it covered. Finally, the Food, Drug, and Cosmetics Act says that courts shall presume for enforcement purposes all food products, including bottled water, are part of interstate commerce. Specifically, 21 U.S.C. §379a of the law reads: “In any action to enforce the requirements of this Act respecting a device, food, drug, or cosmetic the connection with interstate commerce required for jurisdiction in such action shall be presumed to exist.”
In Senate testimony the NRDC admits that the most likely case is that bottled water falls under FDA jurisdiction. In a footnote to the claim that the water isn’t regulated by FDA, the NRDC staffer notes: “However, the bottled water industry, by and large, has a significant effect on interstate commerce and many of the products used in the bottling plants—such as the bottles, labels, the caps—move through interstate commerce even if the source of the water may be intrastate. Given the prevalence of moving plastic bottled through interstate commerce, most, if not all, bottled water should fall under FDA’s watch.”
Bottled water providers also must comply with other standards—both public and private. There are state-level regulations, some of which, such as those from California, Pennsylvania, and Florida, are more stringent than federal regulations. In addition, the International Bottled Water Association membership—which covers 85 percent of bottled water—comply with even stricter industry standards. In addition, the association’s membership is subject to unannounced sanitary inspections by two independent groups—the National Sanitation Foundation (NSF) and Underwriters Laboratories (UL).
In the rare case that a bottle of water does not meet a standard, or when it doesn’t meet a California standard, there still is no public health consequence. In fact, a high success rate of meeting EPA/FDA standards indicates that bottled water meets an exceedingly high safety standards. EPA regulators design the regulations with safety factors to ensure that even if consumers are exposed to contamination many times higher than levels allowed by regulation, they would not suffer any public health impact, despite claims by environmental activists suggesting that trace level chemicals in our water may give us cancer. In their landmark study on cancer, scientists Richard Doll and Richard Peto noted back in 1981 when standards were not nearly as stringent: “With the possible exception of asbestos in a few water supplies, we know of no established human carcinogen that is ever present in sufficient quantities in large U.S. water supplies to account for any material percentage of the total risk of cancer.”
A periodic exceedance for chemical contaminants should be of little concern. In fact, EPA regulations do not expect every sample to meet their standards for chemical contaminants. Instead, the levels are averaged over a period of time because the risks of such trace-level chemicals are associated with long-term exposures to contaminants at vastly higher levels over a long period of time. Periodic exceedances of the exceptionally cautious standards are of no consequence, particularly since exceedances were on the order of one to a few parts per billion. Of note, bottled water still meets an even more stringent standard on this point. Unlike EPA regulations for tap water, bottled water companies are not expected to meet the standard on average. They must meet it with every single sample. That makes FDA standards more stringent in this respect.
Finally, environmental activists also suggest that bottled water testing is insufficient compared to tap water regulations. NRDC notes that tap water regulations require local governments to test for bacteria and chemical contaminants far more often than bottled water companies. But there are good reasons for these differences. Tap water must be tested frequently because it source and delivery system mean it is much more likely to become contaminated. Indeed, tap water often comes from surface water sources and then travels through pipes. Moreover, when you consider the volume of water tested, bottled water receives more testing per gallon of water.
Given that bottled water largely meets or exceeds federal tap water standards, there is little reason to fear. In fact, the next section shows that bottled water quality is often higher than tap water quality and that it suffers less often from dangerous contamination problems.
Not the Same as Tap
September 4, 2008 by Angela Logomasini, Ph.D.
Filed under Facts
Bottled water is substantially different from tap water. Yet people are calling for bottled water regulation because they say it is either the same as tap or of a lower quality. The EPA points out, both tap and bottled water vary from one source to the next. Bottled water that is labeled “purified” originates from the tap, but the final product is different because the tap water undergoes additional treatments to eliminate flavors from chlorination among other things. In other words, purified bottled water that comes from public drinking water systems is a higher quality, since it receives additional treatment after meeting tap water standards. In contrast, unpurified tap water is less predictable in terms of flavor and quality because it can take on flavors from disinfectants as well as from contaminants from pipes.
Activists like to suggest that a large portion of bottled water is simply “bottled tap water,” and hence, we should not buy any bottled water. But according to the International Bottled Water Association 75 percent of bottled water is from sources other than municipal systems. Nonetheless, the NRDC uses this data to suggest that as much as 25 percent of bottled water is simply tap water that may or may not receive additional treatments. That may be true, but so what? A good portion of that 25 percent does receive additional treatments and hence is higher quality. All consumers need to do is look at the labels and select a water that meets their needs. Many people simply want the convenience of the packaging. Others can simply look at the label to select one that meets their needs. In addition to complying with FDA labeling mandates, most bottles include phone numbers where consumers can access additional information and have their questions answered.
Like most consumer products, bottled water qualities can vary considerably from one brand to the next, but labeling can help consumers decide which kind they want. Unlike tap water, bottled water manufacturers have a package on which they can provide information on the water source, and most provide such information. The FDA sets labeling standards that help consumers understand the terms on bottled water labels, as detailed in Table I of this document.
In terms of safety, both tap and bottled water are generally good, yet available data indicates that bottled water has a better safety record. If you compare health-related problems that have been connected to both bottled and tap water, tap water has more documented health-related incidents. For example, one EPA study documents a total of 207 waterborne-disease outbreaks producing 433,947 documented illnesses and 73 deaths between 1991 and 2002. Most of these cases were the result of a major outbreak of the pathogen cryptosporidium in Milwaukee’s tap water during 1993, which produced 403,000 illnesses and 50 deaths. In addition, many tap water problems go unreported and undetected. Of note, while many people focus on risks associated with trace-level chemicals in the water supply, the overwhelming majority of deaths resulted from microbiological pathogens in tap water. In addition to the deaths resulting from cryptosporidium, EPA researchers report:
“Another protozoan agent, Naegleria fowleri was responsible for two deaths in a single WBDO in 2002. During 1991–2002, deaths were also attributed to bacterial pathogens: seven due to Salmonella typhimurium, six due to Vibrio cholerae, non 01, four due to Legionella; two deaths occurred during a WBDO caused by both E. coli O157:H7 and Campylobacter jejuni. The remaining deaths during this period occurred during WBDOs caused by excess fluoride concentration (one death) and norovirus (one death).”
The EPA also reports that many of the deaths were among people with compromised immune systems. For example, of 54 deaths associated with cryptosporidium during 1991-2002, 85 percent were among individuals suffering with AIDS.
According to the EPA, the risks of tap water are underestimated. In fact, agency officials believe that many Americans suffer from acute gastrointestinal illness (diarrhea) every year from drinking tap water. In one study, the EPA estimates that 16.4 million Americans suffer from acute gastrointestinal illnesses annually. This number is simply an estimate, but it is indicative of the potential illnesses associated with tap water, with the vast majority being minor and short-term, fortunately.
In recent years, tap water illnesses have been increasingly related to the means of distribution via piping. Keeping the water clean from the treatment plant to the tap offers challenges that do not exist for sanitary packaged bottled water. Potential contamination in municipal pipes is a key reason why bottled water is recommended for ill individuals. Dr. Stephen C. Edberg, director of the Clinical Microbiology Laboratory of the Yale-New Haven Hospital and professor of Laboratory Medicine, Internal Medicine and Chemical Engineering at Yale University, notes the differences:
“The greatest disparity between tap water and bottled water is the distribution system. Tap is delivered through pipes where the most variability in the safety of tap water occurs. On average, a city loses between 18 percent and 44 percent of its water from leaking pipes. These pipes are often in the same trenches as our sewer pipes. It has been shown that even under normal operating conditions, pressure changes in the distribution system can cause environmental intrusion from the outside of the pipe to the inside, allowing sewage contamination to enter drinking water systems. This open distribution system is more vulnerable to contamination.”
Bottled water, on the other hand, uses a more controlled process that can avoid external contamination from the source through the bottling process. Moreover, the bottle hygienically seals in the quality.
Government agencies have not found nearly as many health-related problems associated with bottled water. Both the sources of water used for bottled water (much of which comes from ground rather than surface waters, which tends to be cleaner) and their delivery systems play a critical role in keeping risks low. Edberg reports: “the CDC has associated bottled water with less than 10 incidents resulting in possible cases of illness in the past 35 years.”
“There has not been a documented major outbreak of illness from bottled water in the U.S.,” says Amy Simonne, Assistant Professor for Food Safety and Quality at the University of Florida. The fact that there hasn’t been a major outbreak does not mean there are no isolated cases of individual problems. The CDC reports a handful of cases over the past several decades in their reports on waterborne illnesses in Morbidity and Mortality Weekly Report. Yet the few illnesses associated with bottled water are dwarfed by the more numerous tap water related illnesses.
Like all food products, bottled water is also subject to recalls under FDA guidelines, which have occurred periodically. Yet these recalls are not associated with many actual illnesses, nor are they related to any deaths. Peter H. Gleick, author of The World of Water, The Biennial Report on Freshwater Resources: 2004-2005, lists a number of such recalls. None of them produced significant, long-term public health impacts. Of the 12 cases he found, 10 occurred in the United States and, of those, 10 involved FDA recalls, and one involved a recall by the state of Pennsylvania for a local water provider. In the Pennsylvania case, the water contained coliforms, and one person reported some gastrointestinal distress. All of the FDA recalls fell within Class II and III for food recalls. Both classifications indicate that the FDA determined the risks of any long-term problems to be “remote” or “unlikely.” The exact definitions of these classes are as follows:
Class II recall: “A situation in which use of or exposure to a volatile product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Class III recall: “A situation in which use of or exposure to a volatile product is not likely to cause adverse health consequences.”
More recently, there have been a few additional recalls, some which have captured headlines, although the risk remained low. In 2004, Coca-Cola recalled Dasani bottled water overseas because it contained elevated levels of the chemical bromate. Nestle and Wegmans supermarkets conducted similar recalls in 2006. While much hype in the press makes it appear as serious, the risk was actually very low and the impact negligible. Bromate is a byproduct of disinfection with ozone, which water companies ensure stays below levels of concern.
Even though the recalls involved exceedances of standards, the levels of bromate in the water still did not pose acute or long-term health risks. Theoretically, long term risks—such as cancer risks—would involve drinking a substantial amount of this water over several decades. Moreover, according to the EPA’s assessmentof bromate, there is no human data indicating a cancer risk. Instead, bromate causes cancer in rodents that are administered very large doses, which is of questionable relevance to humans who are exposed to trace levels for short intervals. Hence, there is little reason to worry about a periodic short-term exposure to bromate in bottled or tap water.
The NRDC disputes claims that bottled water poses lower risks, but they are hard pressed to come up with much evidence. NRDC claimed in 1999: “However, such outbreaks from contaminated bottled water have indeed occurred and are well documented by CDC and others in the scientific literature.” Yet the group could only identify three such “outbreaks” ever, and only one occurred within a U.S. jurisdiction. In that case, there was an issue with bottled water in the U.S. territory of the Marianas Islands in the Pacific, which NRDC points out is covered by U.S. bottled water law. According to NRDC at least 11 people became sick, with four hospitalizations. However, the fact that NRDC could only find this one incident—compared to the many cases of waterborne problems with tap water—is indicative of an impressive safety record for bottled water.
Ironically, this single U.S. bottled water “disease outbreak” is addressed in a CDC document that underscores the more significant risks posed by tap water-related disease outbreaks. Specifically, the CDC report addressed the largest waterborne disease outbreak in recent decades—the contamination of Milwaukee tap water. CDC notes: “For the 2-year period 1993-1994, 17 states and one territory reported a total of 30 outbreaks associated with drinking water. These outbreaks caused an estimated 405,366 persons to become ill, including 403,000 from an outbreak of cryptosporidiosis in Milwaukee, the largest WBDO ever documented in the United States, and 2,366 from the other 29 outbreaks.” In comparison, the incident in the Marianas Islands appears to be what it was in fact: a rare and unfortunate accidental contamination of bottled water whose impact was relatively small and controlled.
By highlighting the challenges faced in the provision of tap water, this analysis is not meant to suggest that anyone should panic about tap water. The reality is that everything in life involves risks. In fact, much of human history has been characterized by a struggle to avoid dangerous microbes, particularly those in our food and water. Developed nations have made tremendous progress in this area, managing to provide food and water for millions of people every day with relatively few incidents. It is only because we have achieved such high standards that outbreaks have become major news. In the developing world, those challenges remain considerable and poor quality sanitation produces tragic results.
In the United States, problems with our water supply are relatively rare, but risks remain that demand some attention. When compared to bottled water, risks appear to be somewhat higher for tap water in large measure because of its distribution system. This reality simply underscores the fact that the two products are not the same. Accordingly, bottled water has important applications for individuals with special needs, for emergency situations, and for individuals who simply desire the qualities associated with bottled water.
Footprints?
September 4, 2008 by Angela Logomasini, Ph.D.
Filed under Facts
Bottled water is under attack in part because people make the silly claims that it has an impact on global climate and uses “too much” energy. Such attacks are arbitrary and do not mesh with reality.
First, even if we could eliminate bottled water altogether, global climate would remain unaffected. After all, if claims about human impacts on climate are correct, even drastic changes in the global economy would make little difference. The most rational strategies would be to manage adverse impacts if any arise and capitalize on any potential good ones (such as increased agricultural productivity). Banning a commodity like bottled water won’t do that; it would simply deny choice.
Consider the fact that if human-induced global warming predictions were correct (big assumption), and all the nations of the world met the ambitious goal of returning the world below 1990 carbon emission levels as outlined in the Kyoto Protocol—we still would have accomplished very little. Danish university professor Bjorn Lomborg pointed out in the British newspaper The Guardian:
“The effect of Kyoto (and even more so Bonn) on the climate will be minuscule. All models agree that the Kyoto Protocol will have surprisingly little impact. One model by a lead author of the 1996 IPCC report shows us how an expected temperature increase of 2.1°C in 2100 will be diminished by the protocol to an increase of 1.9°C. Or to put it more clearly, the temperature that we would have experienced in 2094 we have now postponed to 2100. In essence, the Kyoto Protocol does not negate global warming but merely buys the world six years.”
But even the prospect of saving six years may be overly optimistic. A letter to the United Nations signed by 100 climate scientists suggests that humans can have little impact on global climate. They note:
“It is not possible to stop climate change, a natural phenomenon that has affected humanity through the ages. Geological, archaeological, oral and written histories all attest to the dramatic challenges posed to past societies from unanticipated changes in temperature, precipitation, winds and other climatic variables. We therefore need to equip nations to become resilient to the full range of these natural phenomena by promoting economic growth and wealth generation.”
Given such realities, the idea that taxing or prohibiting plastic bottles matters in terms of global warming is easily dismissed as completely implausible.
In any case, the fact that a product requires energy to transport is not a good reason to regulate, but it is a clever excuse for those who seek to control economic activity. After all, nearly all products in commerce require energy to transport! The real question is: Do these products meet a consumer desire that is worth the cost? The answer to that question is clearly “yes” because people freely chose to buy bottled water.
But often overlooked in this debate is the fact that plastic bottles are an incredibly energy efficient product. The lightweight quality of plastic bottles means that transport is cheaper than the alternatives of glass and aluminum. Moreover, while plastic bottles might not be recycled at the same rate as aluminum or glass, they require vastly less energy to produce than glass or aluminum bottles, which is why they are less expensive.
These basic points were underscored in studies conducted by the research firm Franklin and Associates in the 1990s. The firm conducted a series of studies on packaging for both industry and government (EPA) sources. These studies involved “life cycle assessment,” a process of assessing a product’s full impact from “cradle to grave.”
A 1993 study focused on beverage containers, measuring their impact from production to disposal. It considered energy and other resources used in manufacturing (raw materials and energy), distributing for sale, collecting for disposal, and final disposal. Products that were recycled were given credits for their portions that are actually fully recycled and used in new products. It assessed each based on the amount of liquid that reached consumers—i.e., it assessed the impact of each product in the delivery of 1,000 gallons of liquid delivered to the market. That way, each product was compared based on its equal contribution to consumers. (See: The Environmental Impact of Soft Drink Delivery Systems: A Comparative Analysis, Washington, D.C.: National Association for Plastic Container Recovery, 1995 Update.)
The results of this assessment are surprising to anyone who thinks that plastic products are bad for the environment because plastic bottles (polyethylene terephthalate or PET bottles in this case) provided considerable energy savings and high points for their environmental value. Plastic bottles used less energy and other resources than the alternatives. The study found that the plastic bottles were 47 percent more energy efficient than aluminum cans and 63 percent more energy efficient than glass bottles. The plastic containers also had the least environmental impact (air emissions and total waterborne wastes) of all soft drink containers.
These findings are not so surprising given the fact that plastics are so lightweight. According to the American Chemistry Council, plastic containers use approximately 90 percent less material by weight than do similarly sized glass containers. Similarly, plastic containers use about 38 percent less material than steel. Moreover, like many products, plastics producers have continued to find ways to reduce the material used for their containers without sacrificing utility. As a result, a two-liter plastic bottle and a one-gallon milk container each weigh about 33 percent less than the same products did during the 1970s.
Solid Waste
September 4, 2008 by Angela Logomasini, Ph.D.
Filed under Facts
Plastic bottles amount to 0.3 percent of the nation’s solid waste. Accordingly, taxing and banning plastic water bottles in workplaces isn’t going to matter in terms of overall waste.
And the fact that plastics don’t biodegrade doesn’t matter, since in a landfill, not much of anything degrades. Landfills are intentionally designed to prevent degradation—to keep the waste intact so that decay does not create problems associated with gases and liquids produced by decomposition. In fact, during the early 1990s, University of Arizona archeologist William Rathje found that there was little or no decomposition of materials placed in landfills. He even found 40-year old newspapers that were still readable and intact food products, including lettuce. (See: Phil Brown, Interpreting Garbage Archaeologist Finds Surprises in Landfill, Albany Times Union, December 7, 1989, B1.)
In addition, some people say we need to reduce use of the plastic bottles because we may soon run out of landfill space. Yet this claim is also unfounded. It was originally made in the 1990s when Congress considered solid waste legislation. At the time, journalists and government researchers reported that existing landfills would close in five to 10 years, and then we would have no where to put our waste. But that is true at any point in time, because landfills last only that long, and new landfills would replace the used up space. There was at the time—and still is—plenty of space for landfills. During the alleged landfill crisis, A. Clark Wiseman of Gonzaga University pointed out that, given projected waste increases, we would still be able to fit the next 1,000 years of trash in a single landfill 120 feet deep, with 44-mile sides. Wiseman’s point is clear: Land disposal needs are small compared with the land available in the 3 million square miles of the contiguous United States. (see: A. Clark Wiseman, U.S. Wastepaper Recycling Policies: Issues and Effects, Washington, DC: Resources for the Future, 1990, 2.)
Problems arise when states fail to permit new facilities. Yet while it is often politically difficult to find sites for these landfills, it is not impossible. Landfill companies have found ways to compensate communities for hosting landfills and hence have been able to continue to provide sufficient landfill space. In fact, new landfills are now designed to be much larger and last longer.
And the public health risk of modern landfills is close to nil. According to one study conducted by academic researchers Kenneth Clinton and Jennifer Chilton, modern sanitary landfills pose a theoretical one in 10 billion risk of cancer for someone exposed to the chemicals for 70 years. This risk level is so low is it unfathomable, especially when you compare it to the much higher risks associated with things we consider relatively safe in every-day life. For example, smoking 1.4 cigarettes during one year, traveling 300 miles by car, traveling 10 miles on a bicycle, living two days in Boston, and eating 40 tablespoons of peanut butter over a year’s time each pose a theoretical risk of one in a million—making these relatively safe activities far more dangerous than depositing anything in a modern landfill. Jennifer Chilton and Kenneth Chilton, “A Critique of Risk Modeling and Risk Assessment of Municipal Landfills Based on U.S. Environmental Protection Agency Techniques,” Waste Management and Research 10, 1992: pp. 505–16; and
Richard Wilson, “Analyzing the Daily Risks of Life,” in Readings in Risk, ed. Theodore S. Glickman and Michael Gough, Washington, D.C.: Resources for the Future, 1990, p. 57).
The Elements
September 4, 2008 by Angela Logomasini, Ph.D.
Filed under Facts
Claims about the risks of chemicals in plastics don’t hold water. The FDA is required to consider all such substances since it regulates water as a food product, and chemicals coming from the bottle would be considered food additives and regulated as such. The FDA ensures that such chemicals never reach levels of concern. And in fact, the FDA could not find any documented health problems associated with such chemicals.
Nonetheless, activists regularly suggest that the public is at risk from trace chemicals coming from plastic bottles of all kinds. One chemical found in plastics that activists claim poses a risk is Bisphenol A, which is used to make polycarbonate containers, such as baby bottles, reusable water bottles (Nalgene water bottles, which ironically environmentalists promote when they call for reusable bottles), five-gallon bottles used for large water coolers, as well as some other products. Activists say that BPA leaches out into the water or other food items in containers and threatens to impact public health, largely by disrupting endocrine systems.
But the best science on the topic shows that the trace levels of BPA that currently exist do not pose any significant health risk. For example:
* After an exhaustive review of the data, the FDA concluded: “An adequate margin of safety exists for BPA at current levels of exposure from food contact uses.”
* In July 2008, the European Food Safety Authority reaffirmed a 2006 study on BPA that found human exposure to the substance through consumer products is not high enough to have any adverse impacts.
* Another comprehensive review of the issue conducted by the National Toxicology Program (NTP) at the National Institutes of Health, came to similar conclusions, finding no direct evidence of any problems among humans. This report expressed minimal to negligible concern for almost all factors. It called for more research in one area and expressed only “some concern” (more significant findings would state “concern” or “serious concern”) because rodent studies showed some association of potential effects on behavior. Yet as NTP noted: “These studies in laboratory animals pro¬vide only limited evidence for adverse effects on development and more research is needed to better understand their implications for human health.” Indeed, the relevance of the impacts on rodents to the potential impacts on humans is questionable.
Despite extensive study and the inability of anyone to document problems with Bisphenol A, the substance is the subject of much hype and press coverage. For example, a headline story in the Washington Post on the draft of the NTP report read: “U.S. Cites Fears on Chemical in Plastics.” The story suggested that government researchers had made a new and major finding on BPA. Yet instead of discovering a problem, the draft brief—like the final report—underscored the fact that researchers have been unable to find any impact on humans from the chemical. The key conclusions in the brief are as follows:
“The NTP has negligible concern that exposure of pregnant women to bisphenol A will result in fetal or neonatal mortality, birth defects or reduced birth weight and growth in their offspring.”
And:
“The NTP concurs with the conclusion of the CERHR Expert Panel on Bisphenol A that there is negligible concern that exposure to bisphenol A causes reproductive effects in non-occupationally exposed adults and minimal concern for workers exposed to higher levels in occupational settings.”
Yet some people still suggest that BPA can mimic endocrine related chemicals and impact public health. The Competitive Enterprise Institute’s Jonathan Tolman helps clarify such risks, showing that they are inconsequential. He notes:
“We are constantly exposed to a variety of other estrogen mimicking compounds in our everyday diet, not from manmade chemicals, but from compounds produced by plants themselves — so called phytoestrogens. All legumes, for example contain estrogen mimicking compounds with soy products being one of the largest contributors.
It would have been helpful [to compare] the levels of exposure of phytoestrogens to the level of exposure to BPA in order to give readers a basis of comparison with which to judge the risk. In 1999, the National Academy of Sciences published its study, Hormonally Active Agents in the Environment, and estimated the potential daily human exposure of various estrogens. According to the NAS study the estimated exposure to BPA in food cans was 6.3 micrograms per day, and BPA in beverage containers was less than 0.75 micrograms per day. By comparison, the exposure to phytoestrogens was estimated at 1,000,000 micrograms per day. Given the huge relative disparity between the exposures to phytoestrogens as compared to BPA concentrations, the risk of BPA in consumer products appears to be about the same as tablespoon of soymilk.”
Moreover, the FDA has repeatedly made clear that it does not consider Bisphenol A to be a problem. It notes:
“Based on our ongoing review, we believe there is a large body of evidence that indicates that FDA-regulated products containing BPA currently on the market are safe and that exposure levels to BPA from food contact materials, including for infants and children, are below those that may cause health effects. However, we will continue to consider new research and information as they become available. This position is consistent with two risk assessments for BPA conducted by the European Food Safety Authority (EFSA) Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food and the Japanese National Institute of Advanced Industrial Science and Technology. Each of these documents considered the question of a possible low-dose effect and concluded that no current health risk exists for BPA at the current exposure level.”
However, the FDA provided a silly disclaimer at the bottom of this document which reads: “At this time, FDA is not recommending that anyone discontinue using products that contain BPA while we continue our risk assessment process. However, concerned consumers should know that several alternatives to polycarbonate baby bottles exist, including glass baby bottles.” The idea that a public health agency would suggest that glass bottles—which can easily break and injure a child—might be a better alternative than unbreakable, lightweight plastic bottles just goes to show how odd the debate has become.
Another concern about plastic water bottles is being raised in e-mail alerts that tell people they can get cancer from bottles of water especially if they are left in the car or put in the freezer. Some claim that these problems were reported by The Bloomberg School of Public Health at Johns Hopkins University. However, Johns Hopkins issued a statement noting that these e-mails were a hoax and not endorsed by the school.
Nonetheless, the e-mails indicate that the extreme temperatures release chemicals from the plastics into the water. One chemical they claim that the bottles release is called Di(2-ethylhexyl) (DEHA), which is an additive used to make certain plastics. In addition the criticisms issued by Johns Hopkins about these claims, the American Cancer Society also refutes the DEHA claim noting that DEHA isn’t even used to make plastic water bottles. It also points out that the EPA and the International Agency for Research on Cancer (IARC) of the World Health Organization (WHO) both have reported that there is no good evidence that DEHA produces significant health or environmental effects. After studying the issue in 1995, the EPA concluded that DEHA “cannot reasonably be anticipated to cause cancer, teratogenic effects, immunotoxicity, neurotoxicity, gene mutations, liver, kidney, reproductive, or developmental toxicity or other serious or irreversible chronic health effects; and …it cannot reasonably be anticipated to cause significant and serious adverse effects on the environment.” (see: U.S. Environmental Protection Agency, Federal Register 60, no. 7, August 1, 1995: 39132-39134.)
Similarly the IARC monograph on the topic reports: “No epidemiological data relevant to the carcinogenicity of di(2-ethylhexyl) adipate were available. There is limited evidence in experimental animals for the carcinogenicity of di(2-ethylhexyl) adipate.” Its overall evaluation is: “Di(2-ethylhexyl) adipate is not classifiable as to its carcinogenicity to humans.”
Similarly, Johns Hopkins notes that there are no dioxins in plastic water bottles to worry about, despite claims in various e-mail alerts.” “There are no dioxins in plastics. In addition, freezing actually works against the release of chemicals. Chemicals do not diffuse as readily in cold temperatures, which would limit chemical release if there were dioxins in plastic, and we don’t think there are,” notes Rolf Halden, Ph.D., P.E., assistant professor in the Department of Environmental Health Sciences and the Center for Water and Health at the Johns Hopkins Bloomberg School of Public Health.
Halden offers a perspective as well: “Don’t be afraid of drinking water. It is very important to drink adequate amounts of water and, by the way that’s in addition to all the coffee, beer and other diuretics we love to consume. Unless you are drinking really bad water, you are more likely to suffer from the adverse effects of dehydration than from the minuscule amounts of chemical contaminants present in your water supply. Relatively speaking, the risk from exposure to microbial contaminants is much greater than that from chemicals.”
Environmental activists also suggest that we should worry about the effects of chemicals called phthalates that are used in a variety of products. Phthalates are a group of substances used to make polyvinyl chloride (PVC) plastics flexible, and they are found in medical devices such as vinyl tubing, home siding, plastic pipes, toys and other items. Phthalates have been in use for about 50 years without any reported human health problems.
Ironically, the greens urge people not to drink bottled water to avoid these chemicals when in fact they are not even used in the bottles. Yet recently a staff attorney for the NRDC reported to congressional committee that we should fear phthalates in our bottled water because the phthalate DEHP—(2-ethylhexyl) phthalate—is used for the gasket of the plastic cap. Among her complaints was the fact that the FDA does not impose the EPA drinking water standard for phthalates to bottled water.
These activists are clearly grasping at straws by suggesting that we would worry about a small piece of plastic used inside the cap to help keep the seal from leaking. Contact with the surface of the water in this case, would be small and occurs only when the water bottles are not upright. Accordingly the exposure level from this small, thin piece of plastic is tiny. In fact, the NRDC study on bottled water only found two samples out of 1,000 that contained phthalates. One sample was in compliance with EPA’s standard and the other was above it by only a few parts per billion. It is worth underscoring the fact that NRDC did not detect phthalates in 99.8 percent of the samples, which is why FDA does not apply the EPA standard for phthalates. The phthalate standard is simply not relevant because exposure level in bottled water is slim to none.
In any case, there is little need to worry about the impacts of phthalates from other consumer products where exposure might be more than that found from a gasket in a bottle cap. According to the Agency for Toxic Substances and Disease Research (ATSDR) at the CDC:
“DEHP, at the levels found in the environment, is not expected to cause adverse health effects in humans. A man who voluntarily swallowed 10 g (approximately 0.4 ounces) of DEHP had stomach irritation and diarrhea. Most of what we know about the health effects of DEHP comes from studies of rats and mice that were given DEHP in their food, or the DEHP was placed in their stomach with the aid of a tube through their mouth. In most of these studies, the amounts of DEHP given to the animals were much higher than the amounts found in the environment. Rats and mice appear to be particularly sensitive to some of the effects of DEHP. Thus, because certain animal models may not apply to humans, it is more difficult to predict some of the health effects of DEHP in humans using information from these studies.”
ASTDR notes that long-time exposure of DEHP to rats and mice has produced cancer in the rodents. Such studies led the Department of Health and Human Services to report that DEHP “reasonably be anticipated to be a human carcinogen” and the U.S. EPA to classify it as “a probable human carcinogen.” However, ASTDR points out that basing such classifications on rodent tests is questionable “because of the differences in how the livers of humans and primates respond to DEHP as compared with the livers of rats and mice.” For that reason, the International Agency for Research on Cancer (IARC)—a research body of the World Health Organization—changed its classification for DEHP from “possibly carcinogenic to humans” to “cannot be classified as to its carcinogenicity to humans.” Specifically, IARC notes: DEHP is”not classifiable as to its carcinogenicity to humans” because “the mechanism by which di(2-ethylhexyl) phthalate increases the incidence of hepatocellular tumours in rats and mice is not relevant to humans.”
In addition, a 15-year scientific evaluation of DEHP produced by the European Union assessed the impacts of DEHP use in the medical field. DEHP is used for plastic tubing, medical devices and blood bags. As a result, the highest human exposures to DEHP occur via medical equipment, particularly for individuals who are regularly exposed—such as kidney dialysis patients. Yet the EU researchers could not find any measurable adverse health effects of DEHP to individuals exposed to it at the highest levels. They do note its importance and value in providing important medical treatments. A summary of the report says that it cannot show that there is no risk (since no one can prove a negative), but they also could not find any health effects from DEHP exposure even among individuals who are most exposed. The report notes:
“The general view of DEHP toxicity is therefore that mechanisms for adverse effects do exist in rodents, but that these do not appear to be of great significance in non-human primates and that the evidence that such mechanisms could be operative in humans is lacking. … However there are no reports concerning any adverse effects in humans following exposure to DEHP-PVC, even in neonates or other groups of relatively high exposure. So far, for example, there are no indications that neonates of high DEHP exposure have any altered long-term fertility patterns. … There are also other groups of patients or individuals who experience prolonged periods of elevated DEHP exposure, including patients on haemodialysis or in receipt of repeated blood product transfusions, where risks and benefits should be considered carefully. At the present there is no evidence that any of these groups do experience DEHP related adverse effects.”
Unfortunately, groups continue to cite periodic studies that they say raises doubts about plastic bottles and other plastic products. However, such studies are often misinterpreted in the public press and single study that might raise issues for further research should not be used to dismiss decades of research. Policymakers and others should view such claims with caution rather than allow activists to generate unwarranted fears.
