January 26, 2011

International Bottled Water Association

IBWA Response to January 2011 Environmental Working Group Report on Bottled Water

On January 5, 2011, the Environmental Working Group (EWG) issued a report criticizing the information on bottled water product labels (including a scorecard grading several bottled water brands). The EWG report contains many false and misleading statements and is based on subjective criteria that are arbitrary and irrelevant to any legal requirements. Provided below is a summary of the most erroneous claims made by EWG and IBWAs statement of the facts. 1. The Safety and Regulation of Bottled Water The EWG report makes several false and misleading statements about the safety of bottled water. Moreover, EWG claims that bottled water is less regulated than tap water. IBWA Response: Bottled water is a safe, healthy, and convenient packaged food product, which is comprehensively regulated at both the federal and state level. At the federal level, bottled water must comply with the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 301 et seq.) and several parts of Title 21 of the Code of Federal Regulations. Section 410 of FFDCA requires that the Food and Drug Administrations (FDA) bottled water regulations be as stringent and as protective of the public health as the U.S. Environmental Protection Agencys (EPA) tap water standards. Bottled water products - whether from groundwater or public water sources - are produced utilizing a multi-barrier approach. From source to finished product, a multi-barrier approach helps prevent possible harmful contamination to the finished product as well as storage, production, and transportation equipment. Measures in a multi-barrier approach may include one or more of the following: source protection, source monitoring, reverse osmosis, distillation, micro-filtration, carbon filtration, ozonation, ultraviolet (UV) light or other safe and effective methods. Many of the steps in a multi-barrier system are effective in safeguarding bottled water from microbiological and other contamination. FDA has issued comprehensive bottled water Standards of Identity, which provide uniform requirements and definitions for the following bottled water classifications: bottled, drinking, artesian, groundwater, distilled, deionized, reverse osmosis, mineral, purified, sparkling, spring, sterile, and well water. (21 C.F.R. 165.110 (a)) FDA has also established bottled water Standards of Quality for more than 90 substances. (21 C.F.R. 165.110 (b)) Most FDA bottled water quality standards are the same as EPAs maximum contaminant levels (MCL) for tap water systems. The few differences are usually the result of the substance not being found in bottled water or the substance is regulated under another provision of law such as FDAs food additives program.

At a July 8, 2009 hearing before the United States House of Representatives Subcommittee on Oversight and Investigations, an FDA official testified that the agency is aware of no major outbreaks of illness or serious safety concerns associated with bottled water in the past decade. At that same hearing, the Government Accountability Office (GAO) made public its report on bottled water, which found that based on a survey of water quality and health protection officials in all 50 states and the District of Columbia there was no evidence that bottled water caused any illnesses during the previous five years. (See United States Government Accountability Office Report on Bottled Water, GAO-09-610, June 2009.) In contrast, EPA scientists and researchers have estimated that tap water consumption is the cause of over 16 million cases of acute gastrointestinal illness (vomiting/diarrhea) in the United States each year (Messner M., et al., Journal of Water and Health, 2006; 4(Suppl 2):201-40). EWGs report suggests that this is a tap water versus bottled water issue. However, most people who drink bottled water also drink tap water, depending on the circumstances. Consumers choose bottled water for several reasons, including taste, quality, and convenience. Bottled water is also an alternative to other packaged beverages when consumers want to eliminate or moderate calories, caffeine, sugar, artificial flavors or colors, alcohol and other ingredients from their diets. At a time when obesity, diabetes and heart disease are so prevalent, the consumption of water, whether from the bottle or the tap, is a good thing, and any actions (such as the EWG report) that discourage people from drinking bottled water are not in the publics interest. 2. Bottled Water Information Provided to Consumers EWG claims that bottled water companies keep secret certain information about their products. In particular, EWG believes that bottled water companies should provide consumers with information on the source of the water, the treatment of the water, and the quality of the water. IBWA Response: Bottled water companies are not hiding information or keeping it secret. In fact, IBWA supports a consumers right to clear, accurate and comprehensive information about the bottled water products they purchase. All packaged foods and beverage products, including bottled water, have extensive labeling requirements, including a statement of the type of water that is in the container, compliance with the applicable definitions in the FDA Standards of Identity, ingredient labeling, name and place of business of the manufacturer, packer or distributor, net weight, and, if required, nutrition labeling. In addition, almost all bottled water products also have a phone number and/or website address on the label. This contact information allows consumers to get any additional information that they may want that might not already be on the label. This might include the source, treatment, and quality information. Disclosures, such as those required by EPA in Consumer Confidence Reports (CCRs) for public water systems, are not required of any food or beverage product. These products must meet all applicable safety standards and must be manufactured according to FDA regulations. However, bottled water companies voluntarily provide consumers with access to information

about their products. Consumers have multiple choices in brands of bottled water. That is not the case with their public water system. Consumers cannot make a choice of which municipal water is piped into their homes. If a bottled water company does not satisfy a consumers request for more information, that consumer can, and should, choose another brand. The 2000 FDA Feasibility Study Report (65 Fed. Reg. 51836 (2000)) looked at various ways that bottled water information could be communicated to consumers, including company contact information on the label, placing specific contaminant and other information on the label, distributing pamphlets at the point of purchase and providing information via the internet. IBWA agrees with the FDAs conclusion that placing all of the information contained in the CCRs provided by public water systems on bottled water labels is not feasible. FDA concluded that: We agree with comments that stated it is not feasible to provide all of the information that is analogous to that contained in a CCR on a bottled water label. Such information would be excessive in limited label space, particularly on the small, single serving bottles. In addition, information that requires frequent changes due to changing test results may result in a misbranded product. Costs of frequent label changes that are necessary to ensure accurate information on the contents of a bottled water product, due to frequently changing information, may present an economic hardship to companies. Moreover, even annual updates that represent the contaminant history would need information to put the history for all such CCR-type information in context for the consumer and would be excessive in limited label space. 3. California Source Labeling EWG claims that California law requires all bottled water labels to state the source of the water. In fact, this was one of the key criteria used by EWG when grading the bottled water products in its report. IBWA Response: EWG has misread the California law on this subject. The relevant statute (Health and Safety Code Section 111170 (f) (2)) states that the bottled water label or package insert must state the source of the bottled water, in compliance with applicable state and federal regulations. (Emphasis added.) There is, however, no California regulation that requires source labeling for bottled water. Moreover, the only federal regulation on source labeling requires a bottled water product from a municipal water source to disclose that fact on the label if it does not meet the FDA Standard of Identity for purified or sterile water. (See 21 C.F.R. 165.110 (3) (ii)) Therefore, the only source labeling requirement for bottled water sold in California is the one promulgated by FDA. Therefore, EWG unfairly assigned lower grades to many bottled water brands based on the false premise that these products didnt meet the California source labeling law. 4. Bottled Water Municipal Sources EWG makes several incorrect or inconsistent statements about the source of bottled water products. IBWA Response: The EWG report provides two different figures concerning the amount of bottled water that comes from municipal sources. On page 6 of the report EWG states that most bottled water companies (i.e., more than half) draw their product from municipal tap water. Then, on page 19, EWG says that close to half of all bottled water is sourced from

municipal tap water. In both cases EWG cites the same reports as the source for these statements. EWGs inconsistent statements within the same report and its inability to correctly provide such a basic and easily obtainable fact calls into question the accuracy of the other information contained in its report. According to 2009 figures from the Beverage Marketing Corporation (BMC), 52.2% of retail PET bottled water is from spring sources and 47.8% is from municipal sources. EWG implies that people may be unaware that they are consuming bottled water that is from a municipal water source and has been placed in a bottle without being purified. As mentioned in paragraph three above, this is not the case. If a bottled water products source is a public water system and the finished bottled water product does not meet the FDA Standard of Identity for purified or sterile water, the product label must disclose the public water system source. It is important to note that purified bottled water is not just tap water in a bottle. Once the municipal source water enters the bottled water plant several processes are employed to ensure that it meets the purified or sterile standard of the U.S. Pharmacopeia 23rd Revision. These treatments can include reverse osmosis, distillation, or de-ionization. The finished water product is then placed in a bottle under sanitary conditions and sold to the consumer. 5. Federal Authority to Regulate Bottled Water EWG claims that FDA has no authority over the substantial amount of water bottled and consumed within a single state. IBWA Response: FDA's jurisdiction over bottled water products (and any other product regulated by FDA) extends not only to those products that move in interstate commerce, but to those products sold within a single state that are enclosed in packaging materials that have moved in interstate commerce. Known as the component theory of FDA jurisdiction, courts have long held that if any component of a food product moves in interstate commerce, FDA has jurisdiction over the finished product, regardless of whether the finished product itself moves in interstate commerce. (E.g., United States v. An Article of Food, 752 F.2d 11 (1st Cir. 1985) In the case of bottled water, if the plastic used in the bottles, the plastic used in the caps, the paper and ink used on the labels, any outer packaging materials, and even the water itself comes from out of state, then FDA has jurisdiction over that product. And in todays commercial society, that will almost always be the case. Congress has recognized this fact by enacting a law that expressly presumes that all food and beverage products are sold in interstate commerce. (21 U.S.C. 379 (a)) 6. Federal Regulation of Spring Water On page 27, EWG lists 30 bottled water products and claims that they do not provide purification information on their labels. IBWA Response: All 30 of the products on this list are spring waters or artesian waters. What EWG fails to recognize and explain is that under FDA regulations a company that produces a natural spring water, artesian water, or mineral water cannot treat or process (including purification) the water and still label it as any of these product types. (21 C.F.R. 165.110 (a)) Purifying any of these types of water would cause them to be misbranded and subject to regulatory action. It is unreasonable and unfair for EWG to criticize and provide a

lower score to a product when it cannot meet EWGs subjective and irrelevant criteria without being in violation of federal law. 7. 2008 EWG Report on Bottled Water Citing its own 2008 report, EWG claims that it found 38 contaminants in 10 bottled water brands. IBWA Response: The 2008 EWG report contains false claims and exaggerations about bottled water products. It provides results from a market basket testing program that EWG conducted on ten brands of bottled water in nine states and the District of Columbia. This is certainly not a representative sample of bottled water products, which the report acknowledges. Moreover, the EWG report is based on the faulty premise that if any substance is present in a bottled water product, even if it does not exceed the established regulatory limit or no standard has been set, then it poses a health concern. And EWG repeatedly fails to draw any correlation between levels of substances found in the bottled water brands tested and the actual levels at which health effects would be evident. (See October 14, 2008 IBWA Press Release.) 8. Safety of Plastic Bottled Water Containers EWG claims that plastic bottled water bottles contain chemical substances that leach into the water. IBWA Response: Bottled water containers, as with all food packaging materials, must be made from FDA-approved food contact substances. Thus, the plastic and glass containers that are used for bottled water products (which are made from the same materials used in other food product containers) have undergone FDA scrutiny prior to being available for use in the market place. FDA has determined that the containers used by the bottled water industry are safe for use with food and beverage products, including bottled water, and that they do not pose a health risk to consumers. 9. Bisphenol A EWG claims that bisphenol A is a harmful substance. IBWA Response: Bisphenol A (BPA) is a chemical building block used primarily to make polycarbonate plastic and epoxy resins. Polycarbonate plastic has been the material of choice for food and beverage product containers for nearly 50 years because it is lightweight, highly shatter-resistant, and transparent. It is widely used in various food containers and many other everyday items, such as eyeglasses and compact discs. Many bottled water companies use polycarbonate plastic for their 3 and 5 gallon water cooler bottles. It is not, however, used in any retail-sized PET bottled water containers. Many international studies have been conducted to assess the potential for trace levels of BPA to migrate from lined cans or polycarbonate bottles into foods or beverages. The conclusions from those studies and comprehensive safety evaluations by government bodies worldwide are that polycarbonate bottles are safe for consumer use. Regulatory agencies in several countries have also ruled favorably on the safety of BPA, including the U.S. Food and Drug Administration (FDA), European Food Safety Authority (EFSA), Swiss Federal Office of Public Health, French Food Safety Authority, Health Canada (the FDA equivalent in Canada,) Food Standards Australia New Zealand (FSANZ) and the Japanese National Institute of Advanced Industrial Science and Technology (NIAIST).

The consensus among these regulatory agencies is that the current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and children. As noted by Health Canada, an adult would have to drink approximately 1,000 liters (or 264 gallons) of water from polycarbonate water cooler bottles every day to approach the science-based safe intake limit for BPA recently established in Canada. When issuing its January 2010 statement on this subject, FDA did not take any formal action to prohibit the use of BPA in any food products. In fact, FDA cautioned against making any changes in food packaging or consumption by either industry or consumers that could jeopardize food safety or reduce intake of food needed for good nutrition. FDA supports further studies, by both governmental and non-governmental entities, to provide additional information and address claimed uncertainties about the safety of BPA. FDAs National Center for Toxicological Research is pursuing a set of studies on the safety of low doses of BPA, and studies are being pursued in collaboration with the National Toxicology Program and with support and input from the National Institute for Environmental Health Sciences. The National Institute of Environmental Health Sciences is also providing $30 million in funding to study BPA, which includes support both for FDA studies and external grants. IBWA is very supportive of FDAs extensive ongoing research regarding the safety of BPA, and strongly believes that this work will continue to confirm the safety of this substance. 10. The Environmental Impact of Bottled Water EWG makes several false claims about the environmental impact of bottled water. IBWA Response: Contrary to EWGs claims, the bottled water industry is a good steward of the environment. Bottled water companies have for many years been taking actions to reduce their environmental footprint. For example, the bottled water industry is using much lighter weight plastics for its containers. Over the past eight years the gram weight of the 16.9 ounce single serve PET bottled water container has dropped by 32.6%. (BMC Report, February 2010) The average PET bottled water container weighed 18.9 grams in 2000 and by 2008 the average amount of PET resin in each bottle has declined to 12.7 grams. BMC estimated that during this time span, more than 1.3 billion grams of PET resin have been saved by the bottled water industry through container light-weighting. The bottled water industry is also developing new technologies in product packaging, such as the use of recycled content, biodegradable and compostable materials, and is utilizing more fuel efficient means of transportation. All bottled water containers are one-hundred percent recyclable. In 2009, the recycling rate for PET bottled water containers reached 31%. (National Association of PET Container Resources (NAPCOR) Report, December 2010) This figure has doubled in the past five years. While this is encouraging news, it is also a reminder that more needs to be done to expand recycling efforts and collection methods across the country. As a result, in June 2010, IBWA approved an innovative framework for a Material Recovery Program that can serve as

the blueprint for local communities to increase recycling through the support and participation of all stakeholders. This program will assist in developing new, comprehensive solutions to help manage solid waste in communities throughout in the United States by having all consumer product companies working together with state and local governments to improve recycling and waste collection efforts. IBWAs Material Recovery Program framework supports state-authorized public/private corporations that: 1) establish in each community specific recycling goals to increase recycling access and rates; 2) generate revenue for grants from annual consumer product company producer responsibility fees and local/state government contributions; 3) fund local government recycling infrastructure improvements and consumer education programs; and 4) dissolve when local recycling goals have been met. While the bottled water industry supports effective environmental conservation policies, we strongly believe that any efforts to reduce the environmental impact of packaging must focus on all consumer goods and not target any one industry. Bottled water is just one of thousands of food and beverage products packaged in plastic containers. According to EPA, bottled water containers make up just one-third of one percent of the entire waste stream. Therefore, any proposed solutions must cover all consumer products or they will be ineffective in dealing with the comprehensive environmental issue. The EWG report states that more than 30 million barrels of oil are used each year to produce and transport bottled water products. That statement demonstrates a fundamental misunderstanding of how plastic containers are made. Most commercial plastic materials in the United States are derived from oil by-products leftover from gasoline production. The sticky solids that remain from oil refining are literally recycled into pellets that are melted and formed into plastic materials. It is misleading to state or imply that virgin barrels of oil are dedicated to making plastic bottles. The bottled water industry uses minimal amounts of ground water to produce an important consumer productand does so with great efficiency. According to a 2005 study by the Drinking Water Research Foundation (DWRF), annual bottled water production accounts for less than 2/100 of one percent (0.02%) of the total groundwater withdrawn in the United States each year. Additionally, based on information gathered in the DWRF study, in 2001, 87% of the water withdrawn by bottled water companies, on average, was actually bottled for consumption by humans, so the bottling process is a very efficient one. Because a long-term sustainable supply of high-quality water is literally the foundation and lifeblood of bottled water companies, IBWA member bottlers recognize the critical importance of environmental conservation and stewardship of all water resources. Bottled water companies perform hydro-geological assessments, monitor the quality and quantity at source wells, purchase surrounding land for protection and recharge of their source and participate in local and regional water stewardship partnerships on aquifer protection. Groundwater is a renewable natural resource that is replenished through the hydrologic cycle. The duration of the replenishment cycle is influenced by weather patterns, recharge areas and characteristics, geologic settings and other site-specific factors. When developing and using water resources, it is essential that use is balanced with the replenishment cycle and the

requirements of the regional demand for the resource. IBWA supports groundwater management policies, laws and regulations that are comprehensive, science-based, multijurisdictional, treat all users equitably, and balance the rights of current users against the future needs to provide a sustainable resource. 11. The Price of Bottled Water EWG claims that bottled water is up to 1,900 times more expensive than tap water. EWG assumed a flat price of $1.00 per liter, or $3.79 per gallon, which is what they claim most consumers would pay at a convenience store. IBWA Response: According to BMC, the average price per gallon of domestic nonsparkling bottled water was $1.26 in 2009. As a popular retail food product, bottled water is available at many differing price points. By using the price that consumers would pay at a convenience store, EWG is purposely inflating the cost. Actual consumers most often purchase bottled water in cost-saving volume. BMC notes that mass merchandisers/club stores, where the price per gallon is generally much lower, accounted for 36.4% of the volume of retail premium PET water in 2009, and grocery stores accounted for 28.9% of retail PET volume in the same year. The small independents/others category accounted for 26.5% of volume, while convenience stores, where the bottled water price per gallon is likely to be much higher, sold only 5.3% of total retail PET water in 2009. The rest of the volume 2.9% was sold through drug stores. 12. Bottled Water Advertising and Marketing EWG claims that bottled water sales are fueled by expensive marketing and misinformation. IBWA Response: The success of the bottled water industry has been consumer driven and cannot be attributed to costly advertising and marketing campaigns. People realize that bottled water is a safe, healthy, and convenient product, and that is what motivates their purchases. In fact, bottled water companies spend relatively little on advertising and marketing. According to BMC and Kantar Media Intelligence, advertising expenditures for the bottled water industry totaled only $28 million in 2009 one of the lowest spending levels in the beverage industry. In comparison, 2009 advertising expenditures for beer totaled $1 billion, carbonated soft drinks $477 million, fruit beverages $361 million, milk $152 million, energy drinks $132 million, and coffee $110 million. Furthermore, bottled water companies are not hiding any information or misinforming consumers as claimed by EWG. The vast majority of bottled water companies fully comply with all state and federal labeling laws. Moreover, under state and federal law, the advertisements and marketing activities of all consumer products, including bottled water, must be truthful and non-misleading. Any product that does not comply with these requirements is subject to state and federal enforcement action. 13. Study Methodology Pages 36 and 37 of the EWG report outlines the methodology used to acquire and analyze the labels and websites of 173 bottled water products. This section of the report also sets forth EWGs scoring and rating system. IBWA Response: EWGs methodology is flawed and the results of this study are not representative of the bottled water industry. The information reviewed by EWG was obtained

by inviting the public, via common social media outlets, to provide EWG with bottled water labels. This is hardly an accepted method of gathering information for a reliable and representative study. For example, since the labels were separated from the bottles before being sent to EWG, some information (e.g., production date codes that may have been printed on the bottle) may not have been taken into account. EWG received and reviewed 274 unique labels for 173 different bottled water products that were purchased in 29 states. However, approximately 111 (41%) of the labels and 96 (55%) of the products were from California. With such a large percentage of the labels and products coming from just one state, the report cannot be considered representative of the entire United States bottled water industry. Many of the bottled water products reviewed by EWG are private label brands. They are produced by a bottled water company for a brand owner (e.g., a retail store) who then sells or distributes them under their own brand name. When seeking bottled water quality information for some of these private label products EWG only went to the brand owners main website rather than call the toll-free telephone number listed on the label. As a result, EWG gave lower ratings to companies that would have provided water quality information for each of their private label brands if EWG had just called the toll-free telephone number. In at least one instance, when EWG didnt find a website address on a bottled water label they must have searched the Internet and found what they thought was the website of the company that made the product. However, the website EWG lists as a source of information is for an entirely different bottled water product that is made and sold outside the United States by an entirely different company. The EWG report card listing for this product also states that the private label bottled water was purchased in a state in which the retailer does not have any stores. EWGs failure to call toll-free numbers provided on product labels to obtain bottled water quality information, and reporting incorrect information obtained from sources not connected to the brand being graded calls into question the accuracy of the entire EWG scorecard. How many other products were criticized and given poor grades by EWG as a result of incorrect information being used? EWG makes a subjective assessment of the quality of bottled water by suggesting that certain treatments are necessary for the safety of the product and in order to satisfy certain arbitrary scoring criteria in their report. For example, if a bottled water process does not employ advanced treatment, but rather is processed using basic treatment, which is not defined, then the product score is reduced by 0.5 point. If a product requires no treatment, based on the high quality of the source water, that products score is reduced by a full point. The scoring system clearly illustrates EWGs misunderstanding of bottled water definitions, processing and quality by suggesting that only waters treated by reverse osmosis or distillation are safe to drink. Under this scoring practice, no spring water or artesian water, for example, would ever qualify for a full score, even if all consumer information is available.

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As was discussed in paragraph number three above, California law does not require bottled water products to disclose the source on the label. However, when grading the products, EWG gave a lower score to any bottled water that did not comply with the non-existent source labeling requirement. The letter grade key is not substantiated by any information or objective criteria. Moreover, EWG does not assign a numerical score to filtered tap water, but awards it an A grade without any information on the quality of the filtered water after filtration. If the EWG scoring system is applied to filtered tap water, it too would fall short of the minimum score of 8.6 for an A.

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