Haylie Chu – Proposal to Change the Regulations of the Bottled Water

MEMORANDUM

TO:                 Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration FROM:    Haylie Chu, Director of the U.S. Food and Drug Administration Center for Food

                      Safety and Applied Nutrition Food Information

DATE:            April 16, 2014

SUBJECT:      Proposal to Change the Regulations of Bottled Water to Reflect the EPA’s Standards of Tap Water

The U.S. Food and Drug Administration (FDA) has an impressive record of accomplishment in protecting public health by assuring that foods and drugs are sanitized and properly labeled.

While we have done a fair job of regulating and supervising the safety of foods and drugs, there are several areas where health policies are under-regulated. I am writing to inform you about the concerns I have regarding the regulation of bottled water and to propose a plan to change the regulation of bottled water to reflect that of tap water.

The Current Situation

Bottled water is considered one of the most popular beverages in the United States.1 Over 50 percent of Americans consume bottled water regularly, under the assumption that bottled water is cleaner and safer than tap water.2 Although tap water, also known as municipal tap water, has been heavily regulated since the enactment of the 1974 Safe Drinking Water Act, many consumers still maintain the outmoded perception that tap water is dirty and unsafe to drink.

Instead, these consumers turn to bottled water, under the assumption that bottled water comes from cleaner, better-regulated sources—an assumption that water bottlers have keenly  capitalized on by charging significant premiums over tap water. While bottled water does occasionally come from cleaner sources, nearly 50 percent of bottled water originates from municipal tap water.3 For example, Aquafina and Dasani, two of the most popular bottled water brands in the nation, are bottled from purified municipal tap water.4 Given this fact, there appears to be no regulation to ensure that bottled water is cleaner than or superior to tap water.

In 2012, the owners of a Chicago plumbing supply store purchased five-gallon bottles of Mountain Ice spring water only to realize that the bottles were filled with filtered municipal tap water. Nestlé’s Mountain Ice water claims that it is “100% Natural Spring Water” when in reality, its water source is municipal tap water.5 Since there is currently no clear regulation to mandate that water bottlers include the source of their water on the packaging, Nestlé Waters does not disclose the source of its water on its bottles and in its advertising. Thus, customers are misinformed and paid more for water that they could have otherwise purchased for much less as tap water. This case is especially controversial, because Nestlé Waters also consists of other popular bottled water brands, including Arrowhead, Poland Spring, Deer Park, Ozarka, Calistoga, Zephyrhills, and Nestlé Pure Life.6 Given this fact, consumers are concerned whether these related brands also conceal their actual source of water. More importantly, consumers are puzzled why the federal government has not required the disclosure of important information about bottled water such as the water source and any contaminants contained.

Health Concerns

The Natural Resources Defense Council (NRDC) conducted tests on approximately 103 different bottled water brands and discovered the following results:

33 percent (34 out of 103) of the tested water bottles violated the standards for chemical and bacterial contamination such as E. coli or fecal coliform bacteria2
17 percent (18 out of 103) of the tested water bottles violated guidelines for heterotrophic-plate-count (HPC) bacteria2

Since the sample size of the results is only 103 out of a population of 700 available brands of bottled water, it can be extrapolated that many more bottled water brands may contain some contamination. Table 1 in the Appendices features some brands of bottled water that were found to have potentially been contaminated. There is also evidence to show that bottled water is treated for bacteria less frequently than tap water. While tap water is tested more than 100 times a month for coliform bacteria, bottled water is only tested once a week for the bacteria.7 Bottled water is generally treated significantly less than tap water, further raising questions as to whether bottled water is treated enough to mitigate the health risks of the chemical and bacterial contaminants. Yet, millions of Americans still use bottled water as their primary source of drinking water without awareness of its potential health risks.

In 1994, the Center for Disease Control reported a cholera outbreak caused by bottled water in Saipan, Northern Marian Islands—a U.S. territory. FDA bottled water standards apply to this territory to the same extent as they would to any U.S. state. At least eleven people were known to have become ill, and four were hospitalized with serious cases of cholera. During the outbreak, the bottled water tested positive for fecal coliform bacteria, the source of cholera. Although tap water is stringently tested for fecal coliform bacteria under EPA standards—no amount is allowed to be present—bottled water does not face the same standards under FDA standards.

Thus, water that would not have been permitted to be consumed as tap water was consumed as bottled water, and many people fell ill as a result.

Ethical Dilemma

Consumers often buy bottled water with the notion that it is a safer, cleaner alternative to their municipal tap water. This is a notion that bottlers have spent millions of dollars trying to instill into the minds of consumers with claims of advanced filtration techniques and pristine water sources. Yet, these claims are not always true as evident by Nestlé’s case.

According to the Rights Approach from the Five Sources of Ethical Standards, humans have the right to be told the truth.8 Given this approach, it is unethical for bottled water suppliers to withhold any information from consumers. Yet, bottled water suppliers often refrain from including important facts about their water on the packaging because they are not required by the FDA to disclose the information. As such, they take advantage of this non-requirement in order to make their water appear of high quality. Failing to indicate such information on bottle packaging prevents consumers from knowing any health risks that they freely have the right to know.

The bottled water suppliers should not be held completely at fault for violating the rights approach. The reason bottled water suppliers are allowed to refrain from disclosing information on their packaging is because the FDA does not require such disclosure, even though the U.S. Environmental Protection Agency (EPA) does. According to research by the National Resource Defense Council (NRDC), the FDA’s standards for bottled water are relatively lenient compared to the EPA’s standards for tap water.2 Please refer to Table 2 in the Appendices for a detailed comparison of the regulations. While the EPA requires tap water to be free of certain chemicals and bacteria and enforces specific rules on the water testing operations, the FDA does not require the same regulations for bottled water. This stems from the fact that the EPA must abide by the 1974 Safe Drinking Water Act, whereas the FDA does not.2

In order to uphold the rights of consumers to know what is contained in the bottled water they consume, the FDA should reconsider its regulations regarding bottled water. A detailed recommendation is described in the following section.

Recommendation

In light of the ethical dilemma outlined above, the FDA should take steps to implement stricter regulations for water bottlers in order to ensure that the FDA is meeting its mission of ensuring food safety and that consumers properly know what water they are drinking. Consumers buy bottled water often with the expectation that it is cleaner than the water that comes from their taps. Thus, the regulations for bottled water should be as strict if not stricter than the EPA’s regulations that govern municipal tap water. In addition, the FDA should mandate that bottlers accurately market their products: bottled water sourced from municipal tap water supplies should not be marketed as spring water from the mountains. This additional measure should be taken to ensure that consumers are properly informed about the origin and elements of their bottled water.

Implementation Strategy

To implement the recommendation above, the following implementation strategy has been tailored to minimize costs and maximize expediency:

1. Revise FDA’s bottled-water regulations to comply with the Safe Drinking Water Act

The first step the FDA should take to address the aforementioned ethical dilemma is to revise the FDA’s bottled-water regulations to comply with the 1974 Safe Drinking Water Act. As mentioned earlier, much of the discrepancy between the FDA and EPA’s regulations on drinking water stem from the fact that the EPA is federally mandated to abide by the Safe Drinking Water Act, whereas the FDA does not. Under section 410(b)(1) of the Federal Food, Drug, and Cosmetic Act, the FDA must only evaluate the EPA’s decision to regulate contaminants in water, not implement them.2 This section was initially implemented under the presumption that water bottling sources were cleaner than municipal tap water supplies. However, the recent evidence mentioned earlier suggests that this is not the case. Revising the FDA’s regulations to comply with the Safe Drinking Water Act would ensure that bottled water is at least as safe as and of comparable quality to that of tap water. How can the FDA comply with the Safe Drinking Water Act? The FDA must set contaminant thresholds to meet or exceed EPA’s tap water requirements.

2.  Partner with the EPA to develop controls and procedures necessary to enforce new regulations

After having revised the FDA’s regulations on bottled water, the second step the FDA must perform is to develop controls and procedures to enforce the changes. Typically, developing new controls and procedures to enforce new regulations would be a time- consuming and expensive endeavor. Fortunately, there is already an agency with knowledge and experience in enforcing these regulations: the EPA. By partnering with the EPA, the FDA will be able to learn from and model its enforcement procedures after those already put in place by the EPA to regulate tap water. Partnership will not only allow the FDA to develop the procedures at a fraction of the time and cost necessary to develop them from scratch, it will also allow the FDA to avoid many of the complications that often arise from enforcing new regulations with new procedures. Avoiding these complications would help the FDA further reduce the costs to fine-tune controls that are often inadequately accounted for when estimating implementation costs. Specifically, the FDA must work with the EPA to develop the following controls and procedures:

• Inspect water sources and bottling plants
• Adopt bottled water testing procedures
• Ensure proper reporting of test results

3. Codify labeling guidelines and partner with Federal Trade Commission to curb false advertising

Having taken steps to ensure the quality and safety of bottled water, the FDA must also take action to curb false advertising. Typically, it is the U.S. Federal Trade Commission’s (FTC) responsibility to ensure that companies do not mislead consumers with false advertising. However, historically, the FDA has also played an important role in curbing false advertising through its control over food and beverage labeling standards. For example, the ‘organic’ label on organic foods is solely regulated by the FDA: the FDA determines what can and cannot be legally labeled as organic.9 Likewise, if the FDA were to develop guidelines for labels such as spring water, the propensity of labeling fraud will be greatly reduced. With labeling guidelines in place, the FDA can then leverage them to discourage false advertising by partnering with the FTC to reprimand companies that violate the guidelines. Companies that are found to mislead consumers will be punished with a hefty fine or possibly be barred from selling bottled water in the future.

4.Mandate water bottler transparency

In addition to taking steps to ensure the safety and quality of bottled water, the FDA must also take action to promote transparency in order to ensure that bottlers are accurately marketing their products. To do so, the FDA must mandate that water bottlers disclose their water source, treatment method, possible contaminants, and other important information on their packaging. This mandate to provide disclosure has precedent in many other foods and products regulated by the FDA. For example, food producers are always required to disclose the presence of artificial sweeteners in foods due to the negative health effects associated with them. Companies that fail to disclose will not be allowed to sell their products on the market.9 The FDA will not have to incur the cost of this step since the cost of implementing this step will mostly be born by water bottlers.

Please refer to Table 3 in the Appendices for the projected costs of the implementation.

Measurement and Results

To measure the success of the recommendation, the FDA can conduct unannounced semi-annual audits at primary points of potential contamination: water source, bottling, shipping and handling, storage, or point of use. At each randomly selected point of contamination, the FDA will test the quality of the water. If a water bottler fails an audit at any point, it will be barred from producing bottled water until it provides proof that the infractions were rectified and controls were put in place to prevent future contamination. Furthermore, any water source identified as contaminated will be prohibited from being used as a water source for bottled water for a year, and subsequently cannot be used until the contaminants fall below the expected thresholds. Since the audits are unexpected, they will keep the businesses in check at all times.

An example of a successful use of random audits to ensure compliance with regulation is that of The Walt Disney Company. Disney has been successful in its use of unannounced audits to ensure the compliance of its factories both domestically and abroad. The use of unannounced audits require factories to remain compliant with Disney’s labor standards at all times in the case that Disney decides to spontaneously audit the facilities. As a result, the unannounced audits reduce the number of cases in which Disney’s labor standards are violated and serve as a way for Disney to measure the success of the labor regulations that it imposes on its factories.10 Like Disney, the FDA can adopt the unannounced audit program to enforce a measurement system for the proposed recommendation.

After implementing the recommendation, it is expected that the quality of bottled water improve to reflect government-mandated health and production standards. In addition, it is expected that bottled water suppliers will absorb their responsibilities to accurately communicate and disclose relevant information pertaining to their water products such as contaminants and source of water. The recommendation will provide the optimal good for all stakeholders and reduce any potential harm to society at large.

*****

Given the gathered data about the water bottling industry and the lax state of the FDA’s current regulations on bottled water, there exists a need to implement the proposed recommendation to mitigate the potential health risks of bottled water and ensure that bottled-water suppliers do not infringe upon the consumers’ rights to know specifically what is in the bottled water they are consuming. By following the step-by-step implementation strategy outlined in this memo, the FDA will better align its bottled water regulations with its mission of providing safe and clean foods and beverages.

References

Baumgartner, M. (2014, March 3). Study: Bottled Water No Safer Than Tap Water. ABC News. Retrieved May 5, 2014, from http://abcnews.go.com/Business/study-bottled-water- safer-tap-water/story?id=87558
Olson, E. (2013, July 15). Bottled Water. Natural Resources Defense Council. Retrieved May 5, 2014, from http://www.nrdc.org/water/drinking/bw/exesum.asp
Bottled Water: Illusions of Purity. (n.d.). Food Water Watch. Retrieved May 5, 2014, from https://www.foodandwaterwatch.org/water/bottled/bottled-water-illusions-of-purity/
Fishman, C. (2007, July). Message in a Bottle. Fast Company Magazine, 117, 110.
Arumugam, N. (2012, October 19). Nestlé Sued AGAIN For Falsely Representing Bottled Tap Water As Naturally Spring-Sourced. Forbes. Retrieved May 5, 2014, from http://www.forbes.com/sites/nadiaarumugam/2012/10/19/nestle-sued-again-for-falsely- representing-bottled-tap-water-as-naturally-spring-sourced/
McCoy, K. (2012, December 13). Disputes spring up over bottled water sources. USA Today. Retrieved May 5, 2014, from http://www.usatoday.com/story/money/business/2012/12/13/bottled-water-sources- disputed/1768417/
Drinking Water. (2014, April 7). Centers for Disease Control and Prevention. Retrieved May 5, 2014, from http://www.cdc.gov/healthywater/drinking/bottled/
Hanson, K., Andre, C., DeCosse, D., McLean, M., Shanks, T., Meyer, M., et al. (n.d.). A Framework for Thinking Ethically. Santa Clara University. Retrieved May 5, 2014, from http://www.scu.edu/ethics/practicing/decision/framework.html
Home Page. (2014, May 2). U.S. Food and Drug Administration. Retrieved May 5, 2014, from http://www.fda.gov/default.htm
The Walt Disney Company. (2013, April). International Labor Standards Program Manual. Glendale, CA.

Appendices

Table 1: Bottled water brands found with contaminants based on research conducted by the Natural Resources Defense Council

Source: http://www.nrdc.org/water/drinking/bw/chap3.asp

Table 2: Comparison of the key differences between EPA tap water and FDA bottled water as researched by the Natural Resources Defense Council

Source: http://www.nrdc.org/water/drinking/bw/table1.html

Table 3: Projected costs for the implementation based on the Health and Human Services’ 2013 Financial Reports

Costs of Implementation to Change FDA’s Regulations of Bottled Water

Revise FDA’s bottled-water regulations to comply with Safe Drinking Water Act

~$2,000,000             FDA

3. Codify labeling guidelines and partner with Federal Trade Commission to curb false advertising

~$1,500,000             FDA

[Text Box: 4. Mandate water bottler transparency ~$1,000,000 Water Bottlers]

Source:

http://www.hhs.gov/afr/2013-hhs-agency-financial-report.pdf

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