GAPING HOLES IN GOVERNMENT BOTTLED WATER REGULATION

The bottled water industry often makes the claim that it is far better regulated than tap water suppliers are. For example, the International Bottled Water Association (IBWA) testified in 1991 that "When compared to the level of regulation and scrutiny applied to tap water . . .bottled water consumers come out way ahead." ^[103] IBWA asserted that "If one considers the full range of FDA consumer protection standards, bottled water safeguards have been more complete and protective for a longer time than tap water standards." ^[104]

This continues to be the industry argument. In a 1998 fact sheet, for example, IBWA contends, "Quality is in every container of bottled water. It's consistent and it is inspected and monitored by governmental and private laboratories. Unfortunately, tap water can be inconsistent -- sometimes it might be okay while other times it is not." ^[105] The IBWA further declares that "bottled water is strictly regulated on the federal level by the Food and Drug Administration (FDA) and on the state level by state officials. This ensures that all bottled water sold in the United States meets these stringent standards." ^[106]

FDA Rules for Bottled Water Are Generally Less Strict than Tap Water Rules

Our in-depth review indicates that, with few exceptions, federal bottled water regulation is weaker than the tap water regulations facing city water supplies. The bottled water industry is disingenuous in pointing out that there are significant flaws in the tap water regulatory scheme, since many more flaws exist in bottled water rules. Although smaller tap water utilities sometimes face less stringent controls than do bigger cities, it still is clear that federal rules for city tap water generally are more stringent than those for bottled water.

For many years, under the Federal Food, Drug, and Cosmetic Act (FFDCA), FDA was supposed to adopt and apply to bottled water all EPA tap water standards within 180 days after EPA issued those standards. ^[107] FDA was authorized to refuse to apply the EPA tap water standards to bottled water in certain circumstances where it determined and published reasons explaining why they were inappropriate for bottled water. ^[108] What happened, however, was that rather than affirmatively making such determinations, FDA just could not seem to be able to get around to issuing bottled water standards or making determinations at all.

Historically, FDA has lagged in its obligation to apply the EPA standards to bottled water, having adopted only a fraction of EPA tap water standards and often being severely criticized for its inaction. For example, a 1995 Senate committee report noted:

FDA has been slow to act. FDA took 4 years to set standards for the 8 volatile organic chemicals (including benzene) regulated by EPA in 1989. FDA did not set standards for the 35 contaminants covered by EPA's 1991 Phase II rulemaking until December, 1994. Standards for bottled water have not been issued for those contaminants regulated by the [EPA] Phase V rule for tap water, although it was promulgated by EPA in 1992 and became effective for tap water on January 1, 1994. ^[109]

Public and congressional criticism of FDA came to a head after benzene was found in Perrier in 1990, and congressional hearings and a General Accounting Office investigation in 1991 revealed widespread failures by FDA to adopt standards and to oversee the bottled water industry. ^[110] The industry suffered a temporary setback in its growth as a result of the public scrutiny, but ultimately both it and FDA weathered the storm.

The 1996 Safe Drinking Water Act (SDWA) amendments modified the FFDCA to provide that, by operation of law, if FDA does not adopt new EPA tap water rules for bottled water within 180 days, EPA standards will automatically serve as bottled water standards. ^[111] If FDA decides to adopt its own standards, they must be at least as stringent as EPA tap water standards, unless FDA finds that the contaminant does not occur at all in bottled water -- in which case FDA can waive the requirement to have a bottled water standard. ^[112] The current legal status of bottled water standards for contaminants for which EPA had issued standards for tap water before the enactment of the 1996 SDWA amendments, but for which there were no FDA bottled water contaminant standards in effect, is being debated.

NRDC has carefully evaluated the regulatory framework now, more than seven years after the 1990-1991 storm of controversy swirled around the industry, and more than two years after the enactment of the SDWA amendments of 1996. We find that although, from 1993 to 1998, FDA adopted some of the additional bottled water standards it was obliged to adopt (and either decided not to adopt others or simply has not completed rule-making on them), little else has changed. ^[113]

Gaping holes remain in the regulatory fabric for bottled water, and FDA and state resources dedicated to bottled water protection and enforcement generally are thin to nonexistent. For example, FDA's head bottled water regulator estimates that FDA has just one half of a person (full-time equivalent or FTE) per year dedicated to bottled water regulation. ^[114] Similarly, bottled water compliance is a low priority for FDA, so specific figures are not kept for resources dedicated to ensuring it meets standards; the compliance office estimated in 1998 that a likely total of "less than one" FDA staff person (FTE) is dedicated to bottled water compliance. ^[115]

The problems created by this lack of regulatory attention are addressed in detail below. "Voluntary compliance" and "industry self-regulation" seem to be the watchwords for the bottled water industry. While such an approach can be effective with motivated members of an industry, the discussions of contamination problems documented in previous chapters and in the Technical Report (print report only) make it clear that this approach leaves plenty of room for unscrupulous or careless members of the industry to provide substandard products, with little chance of being caught or subject to penalties.

This is not to say that bottled water quality is generally inferior to average tap water quality. We do not believe such a statement is warranted, and in fact NRDC has produced numerous reports documenting the contamination problems of tap water. ^[116]

Our evaluation does show, however, that the regulatory system intended to ensure bottled water quality has enormous gaps. The majority of bottled water, according to FDA, is not covered by federal regulations, and FDA does not regulate or monitor the bottled water that is covered by its rules particularly well.

Gaps and Loopholes in FDA Regulations

1. Water bottled and sold in a single state -- the majority of bottled water sold in the United States -- is not covered by FDA rules, according to FDA.

An estimated 60 to 70 percent of the bottled water sold in the United States is sold in " intrastate commerce" (i.e., it is bottled and sold in the same state). ^[117] For example, the large delivered 5-gallon carboy bottles that are put in office or home water coolers are often intrastate waters, as are many of the brands sold in grocery, convenience, and other stores.

FDA says its bottled water regulations apply only to water "that is in, or is intended to be shipped in, interstate commerce." ^[118] (emphasis added) Thus, according to FDA's interpretation, 60-70 percent of the bottled water sold in the U.S. -- all bottled water sold in intrastate commerce -- apparently is not covered by the FDA rules. This leaves the government regulation of this water, if any, to state governments.

The position that intrastate bottled water is not covered by FDA's rules is based on FDA's interpretation of the limitations of the Federal Food, Drug, and Cosmetic Act, ^[119] which FDA says allows it to regulate only interstate commerce (i.e., water that crosses state lines). This interpretation of the FFDCA has been questioned by experts, including some in the bottled water industry.^[4a] Indeed, the FDA interpretation of the FFDCA appears to be unduly narrow, in light of the clear nexus between virtually all intrastate bottled water sales and interstate commerce, as demonstrated, for instance, in the fact that packaging materials and consumers of the bottled water frequently come from out of state.

The impact of the narrow FDA interpretation cannot be overstated. Our survey of states, reviewed later in this chapter, found that often states have few if any resources dedicated to policing bottled water. Thus, in many states, compliance with federal and state bottled water standards essentially is discretionary for many bottlers, and the public's only protection is voluntary industry self-regulation. This offers little or no protection from fly-by-night bottlers in some states.

The problem of inadequate regulatory protection for intrastate sales of bottled water was identified in 1991 as a significant problem by the General Accounting Office in a report delivered to Congress. ^[120] Nothing has been done by FDA or Congress to remedy the federal regulatory gap.

2. FDA's definition of "bottled water" covered by its standards irrationally exempts many types of bottled water.

FDA's rules exempt many forms of what most of us would consider bottled water from its definition of "bottled water," and therefore, according to FDA, exempts them from all of FDA's specific standards for bottled water testing and contamination. If the product is declared on the bottle ingredient label simply as "water," or as "carbonated water," "disinfected water," "filtered water," "seltzer water," "soda water," "sparkling water," or "tonic water," it is not considered "bottled water" by FDA. ^[121] FDA says it exempted these waters because they are "not understood by the public to be bottled water." ^[122] What is covered by FDA's rules? FDA says it regulates products labeled as "spring water," "mineral water," "drinking water," "bottled water," "purified water," "distilled water," and a few other specific categories of bottled water -- creating enormous confusion for any consumer seeking to figure out whether FDA rules apply or do not apply to a specific water on the grocery store shelf.

We doubt that most consumers would agree that water in a bottle listed on the ingredient label as "water" or "sparkling water" or "filtered water" should be exempted from the specific health-protection standards that cover any other bottled water. California and some other states have chosen a different course than FDA and regulate all water that comes in bottles likely to be ingested by people as bottled water. ^[123] We support this approach and recommend that FDA revise its rules to cover all water intended for drinking or culinary purposes that is likely to be ingested by people and that comes in a bottle, as California and some other states have done.

Industry data indicate that these waters that FDA exempts from the definition of bottled water represent a significant chunk of the overall bottled water industry. For example, a report in the beverage-industry trade press noted that in 1996 there were more than 152 million cases of sparkling water sold in the United States. ^[124] This of course does not include many nonsparkling exempted waters such as "filtered water" or "disinfected water."

For these "non-bottled water" bottled waters, FDA officials have said the specific FDA contamination standards and water-quality testing requirements, as well as the specific bottled water good-manufacturing-practice rules for bottled water, are not applicable. ^[125] Thus, no contamination monitoring is specifically required, and only a vague narrative standard applies, according to FDA, which states that the water cannot be "adulterated" and must be safe, wholesome, and truthfully labeled. These nebulous terms are not defined and, to date, apparently the FDA has never enforced the standard with any of these bottled products.

3. Even water defined as "bottled water" is not specifically required to meet treatment, contamination, or testing standards as strict as those applicable to city tap water.

Water that FDA does define as "bottled water" is not required by federal rules to meet many of the specific standards and testing requirements that apply to city tap water. Some of the important disparities between bottled water and tap water are noted in Table 1 (in chapter 1), and in Tables 6 and 7. This seems to directly contradict the FFDCA's requirement^[126] that bottled water is supposed to be regulated as stringently as tap water.

FDA argues that it retains the authority to act against "adulterated" water (which is not specifically defined) and that its general food-safety authorities give it broad latitude to act if it finds a problem. ^[127] However, there is no indication that FDA has ever acted -- or has any intention of acting -- aggressively to implement and enforce treatment standards akin to those applicable to tap water. Moreover, FDA does very little random monitoring on its own of bottled water quality, so there is little assurance that if a problem does exist, FDA would ever find out about it.

Some of the important incongruities between tap water and bottled water standards follow.

Weaker bacteria rules for bottled water. There is a clear prohibition under EPA rules against any confirmed E. coli or fecal coliform bacteria in tap water. ^[128] FDA has adopted no such prohibition for bottled water. ^[129] Rather, FDA's rules set a maximum number of total coliform bacteria in bottled water, with no specific prohibition on fecal coliform bacteria or E. coli contamination of bottled water. ^[130] FDA's proposal over four years ago (in October 1993^[131]) to issue a ban on all coliform bacteria in bottled water has languished. FDA has no specific plans to finalize this rule in the near future. ^[132]

Moreover, EPA's rules essentially treat excessive heterotrophic-plate-count (HPC) bacteria (i.e., HPC presence greater than 500/ml) as a "positive" for total coliform bacteria for most big-city water supplies; no more than 5 percent of all monthly tap water samples can contain total coliform bacteria. ^[133] FDA has adopted no rules for HPC in bottled water; the agency says if HPC levels exceed 10,000/ml (i.e. 20 times higher than the EPA benchmark for tap water), FDA "will consider conducting a follow-up inspection of domestic bottlers...." ^[134]

In addition, while we certainly do not endorse EPA's water-testing rules for tap water as a panacea for drinking water problems, at least a system serving a larger city (more than 100,000 people) has to test its tap water over 100 times each month for coliform bacteria, on average several times a day. ^[135] Yet bottled water -- even at a huge bottling plant filling millions of water bottles a year -- must be tested for coliform bacteria only once a week under FDA rules. ^[136] (IBWA's model industry code recommends daily testing of its members' water, though IBWA's recommendation is not binding unless adopted under state law -- an action that most states have not taken, as noted in our review of state programs later in this chapter.)

FDA's failure to adopt these bacteriological standards contradicts FFDCA's requirement that FDA standards for bottled water must be at least as strict as tap water standards. ^[137]

No treatment requirements to remove or kill bacteria and parasites in bottled water. Under EPA's tap water rules, which are less than complete, cities using surface water generally must disinfect their water and filter it to remove not only bacteria (e.g., coliform bacteria and Legionella) and viruses, but also certain protozoa such as Giardia (unless they can document and obtain formal approval for a filtration waiver because their water is of very high quality and their source water is highly protected from contamination). ^[138] Yet, as shown in Tables 1 and 6, there are no specific FDA standards requiring bottled water to be disinfected or treated in any way to remove bacteria or parasites^[139] -- another apparent violation of FFDCA's comparability requirement for bottled water and tap water standards.

There is a maximum turbidity standard for bottled water of 5 units (the same as for tap water, though the new tap water maximum is 1 unit effective on December 17, 2001, under a recently issued rule). ^[140] There is no rule, however, requiring that bottled water average less than 0.5 units of turbidity each month -- a requirement that currently applies to tap water and will be dropped (effective on the same date) to 0.3 units (for the 95th percentile level) under the same recent EPA rule. Moreover, while tap water must have ongoing turbidity sampling every four hours, no such requirement applies to bottled water. ^[141] The weaker bottled water rule is of concern because turbidity is in many cases the only indication that water is contaminated with parasites. ^[142]

Despite these serious FDA regulatory gaps, the bottled water industry publicly proclaims, we believe without justification, that consumers should turn to bottled water if they want to avoid Cryptosporidium (the protozoan that sickened 400,000 people and killed more than 100 due to tap water contamination in Milwaukee in 1993^[143]). IBWA states, for example, that FDA rules "ensure that surface water contaminants such as Cryptosporidium and Giardia are not present" in bottled water derived from wells and springs, and that it tells its members to use additional treatment if they produce tap-water-derived bottled water, to assure that Cryptosporidium cannot get into the bottled water. ^[144]

Such public proclamations seem to run contrary to the bottled water industry's own privately expressed concerns about the possibility of Cryptosporidium in bottled water supplies. ^[145] Candid internal communications admit that unless all water bottlers adopt adequate treatment to kill or remove Crypto, they will have a hard time convincing the public that bottled water is immune from such contamination. For instance, the following appeared in the IBWA's in-house publication, urging bottlers to upgrade their treatment to be sure it meets CDC guidelines for removing Cryptosporidium: "How can we expect health groups to endorse our product if we don't ALL meet the [CDC Cryptosporidium removal] guidelines!" ^[146] (emphasis in original). An excellent question, indeed.

No Cryptosporidium and Giardia testing for bottled water. EPA's Information Collection Rule has required that over the past couple of years, big cities that use surface water (systems which serve the majority of the U.S. population) generally must test for common parasites such as viruses, Giardia and Cryptosporidium.^[147] By contrast, FDA rules do not specify that any water bottlers are ever required to do such testing. ^[148]

Weaker standards for some chemical contaminants in bottled water. The regulatory standards for several chemicals in bottled water are also weaker than the standards for city tap water (see Table 6). For example, FDA has refused to set standards or treatment techniques for acrylamide, asbestos, di(2-ethylhexyl)phthalate (DEHP), or epichlorohydrin, ^[149] all of which EPA regulates in tap water.^[4b]

It is a strange twist indeed that DEHP, a probable human carcinogen, possible endocrine-system disrupter, and agent produced in plastics manufacturing that migrates into water from plastic water bottles, is regulated under EPA tap water rules but not under FDA's bottled water rules. ^[150] Logic would suggest that if anything, it is more important to control phthalate in bottled water since, it is so often sold in plastic bottles that can leach this chemical.

In fact, FDA stated when it decided not to adopt a DEHP standard that it was the only chemical contaminant it had proposed to regulate in that package of standards that it was aware occurred in bottled water at levels over the EPA standard. ^[151] Some bottlers and members of the plastics manufacturing industry vigorously opposed a phthalate standard, arguing that it would cause some bottled water to be in violation after storage for long periods. ^[152] As one company put it, "bottled water tested immediately after packaging would meet the 6 ppb [FDA proposed] limit but with storage it is possible that levels might exceed this requirement . . .[so] the proposed amendment . . .[would] effectively ban the use of DEHP in closure sealants for bottled water . . . ." ^[153] Although other members of the bottled water industry supported a phthalate standard, ^[154] FDA bowed to those who objected, and decided not to apply the EPA standard -- or any other standard -- for DEHP in bottled water. ^[155] FDA deferred further action on the DEHP standard indefinitely. This appears to be a clear violation of the Federal Food, Drug and Cosmetic Act, which requires bottled water rules to be at least as stringent as EPA's tap water rules. ^[156]

Similarly, in response to bottled water industry complaints about the burden of having to comply with too many standards (and in particular the costs of testing), in 1996 FDA decided to stay any bottled water standards for nine chemical contaminants that have been regulated in tap water since 1992. The nine were antimony, beryllium, cyanide, diquat, endothall, glyphosate, nickel, thallium, and 2,3,7,8-TCDD (dioxin). ^[157] In this case, however, the outcome appears as if it will be different. In August 1996, Congress mandated that FDA adopt bottled water standards for those nine chemicals within two years of enactment, or EPA's tap water rules for those contaminants would automatically apply to bottled water. ^[158] In response to that congressional mandate, in May 1998, FDA issued a "direct final rule" that would make EPA's tap water standards for these nine contaminants enforceable for bottled water by February 1999. ^[159] In August 1998, FDA confirmed that the new rules for the nine contaminants would finally be subject to regulation in bottled water as of February 2, 1999^[160] -- seven years after EPA issued standards for them in tap water.

There is a ray of light in the FDA bottled water regulatory program. FDA's bottled water standards for lead, copper, and fluoride are stricter than EPA's tap water standards (see Table 6). ^[161] The bottled water industry advocated stricter standards for these contaminants, on health grounds. A cynic might speculate that these standards enable the bottled water industry to claim that its water is more strictly regulated than tap water (a claim some in the industry routinely make) without much of a regulatory bite, since these contaminants are rarely a problem in bottled water. (Lead and copper generally exist in tap water due to leaching from pipes or faucets between the treatment plant and the consumer and should not be found in bottled water; fluoride generally is intentionally added to tap water, though it is sometimes found in bottled water.) However, there is no record of such a rationale influencing the bottled water industry's position.

Weaker chemical-contaminant testing requirements for bottled water. Under EPA rules, a city must test its tap water for many organic chemicals, generally at least once a quarter.^[162] In some cases (such as for trihalomethanes), city tap water systems must test at several locations each quarter.^[4c]

Water bottlers, on the other hand, generally need only test for most chemicals once a year under FDA's rules.^[4d] Moreover, water bottlers currently are exempt from testing for asbestos or phthalate, though there are tap water testing and health standards for these. In addition, tap water supplies must test for 16 additional unregulated contaminants and report the test results to authorities, as noted in Table 7. ^[163] Thus, it is apparent that bottled water testing requirements for some contaminants are less extensive and in depth than those that apply to city water systems.

Bottlers self-test and do not have to use certified labs to test water; tap water suppliers may only use certified labs. Under EPA's regulations, in order to ensure that water test results submitted by drinking water suppliers are accurate and of the highest quality, most tests must be completed by laboratories certified by a state in accordance with EPA criteria. ^[164] This helps to ensure consistent quality assurance and quality control, and reduces the chances of inadvertent or intentional inaccuracies in water testing (although in many states, for some systems it is up to the water system to submit the water to the lab for testing, presenting potential opportunities for mischief).

FDA, on the other hand, relies upon water bottler self-testing and self-selection of laboratories, and has refused to require lab certification. This failure to require certified labs came under criticism from General Accounting Office (GAO) investigators. In a critical 1991 report, GAO noted:

FDA lacks assurance that such [bottled water] tests are done correctly or that the results are reliable. FDA regulations specify that either "qualified bottling plant personnel" or "competent commercial laboratories" use approved water quality test methods...[but] has not defined qualified personnel or competent laboratories, and it does not require that such personnel or laboratories be certified or otherwise establish their qualifications to do the required tests. In contrast, for public drinking water, EPA requires certified laboratories.... ^[165]

Even after this GAO report, FDA has twice refused to require that water bottlers use approved certified laboratories(even when the IBWA petitioned FDA to require them. In 1993, FDA argued:

the Act does not provide a basis for these [lab] approvals. Moreover, the act does not provide authority to the agency to require such approval. Further, even if such authority were provided by the Act, FDA lacks the resources to monitor analytical laboratories and personnel in the absence of a significant public health problem.^[166]

FDA reiterated this position in 1995. ^[167]

We disagree with FDA's narrow reading of the law as not authorizing such certification. For example, FFDCA Chapter IV and section 701 provide broad authority to FDA to promulgate such a requirement. ^[168] FDA takes the position that under its authority under the FFDCA, it can legally require bottlers to use competent commercial laboratories, but for reasons that are not supported, FDA contends that it lacks legal authority to dictate that bottlers must use a certified lab.

In addition, even if FDA did not enjoy the authority to mandate use of certified labs before 1996, Section 410 of the FFDCA as amended by the 1996 SDWA amendments seems to clearly support such a requirement. That newly revised provision of the FFDCA expressly authorizes FDA monitoring regulations for bottled water and makes EPA's tap water rules -- apparently including the EPA's certified-lab requirements -- automatically apply in the case of FDA inaction. ^[169] If, indeed, FDA still believes it lacks the legal authority to require certified labs, FDA should ask Congress for such authority.

With respect to resource constraints, FDA could ask Congress for additional resources for the bottled water program. As suggested in the recommendations in Chapter 1, a one-cent-per-bottle fee on bottled water would ease the FDA resource problem. In addition, it would require no expenditure of FDA resources whatsoever for FDA simply to require that the labs used to test bottled water be EPA-certified (or state-certified with EPA approval) for drinking water testing. This is a commonsense solution that FDA apparently refuses to consider for reasons that are not entirely clear.

While tap water system operators must be trained and certified, bottlers need not be. Under the Safe Drinking Water Act amendments of 1996, tap water suppliers' operators must receive training and be certified as competent to treat water by EPA-approved state authorities, pursuant to federal guidelines for determining the level of competence needed. ^[170] This requirement is widely viewed as an important development, because it will begin to ensure that opportunities for operator error -- often the cause of serious contamination problems and even disease outbreaks in tap water systems -- will be reduced.

Although the IBWA petitioned FDA to require certification of bottling-plant supervisory personnel, FDA denied this petition in 1993. ^[171] FDA reiterated its denial in 1995. ^[172] As in the case of certifying labs, FDA argued that it lacked the authority and the resources to require such certification of bottling-plant personnel.

Again, we disagree on both points; FFDCA Chapter IV and in particular sections 410 and 701 provide FDA with ample authority to require plant personnel to be competent, particularly in light of the 1996 SDWA amendments' incorporation by reference of EPA's National Primary Drinking Water Regulations to bottled water in cases of FDA inaction. On the issue of resources, creative solutions are available, including asking Congress for funds, establishing a per-bottle fee, and/or using independent, FDA-certified trainers and certifiers (such as state or third-party certification organizations using FDA training and certification guidelines).

FDA's source water approval requirement is essentially meaningless. Theoretically, under FDA rules, the source of bottled water must be approved by state or local authorities. ^[173] FDA's description of what is required to be an approved source is sketchy: It "means a source of water...that has been inspected and the water sampled, analyzed, and found to be of a safe and sanitary quality according to applicable laws and regulations of state and local government agencies having jurisdiction." ^[174] There are no guidelines for what is required of these state and local rules, nor is there any explanation of what should be done if there are no state or local rules or jurisdiction.

In discussing why the public should feel comfortable with bottled water quality, the bottled water industry often cites this FDA regulatory requirement for source approval. For example, IBWA's widely disseminated fact sheet for consumers notes:

While bottled water originates from protected sources (75 percent from underground aquifers and springs), tap water comes mostly from rivers and lakes....

[B]ottled water companies are required to use approved sources. There are two types of sources from which bottled water can be drawn: the first type is natural sources (i.e., springs and wells). By law, these sources must be protected from surface intrusion and other environmental influences. This requirement ensures that surface contaminants such as Cryptosporidium and Giardia are not present.

The second source water type is approved potable municipal supplies.... ^[175]

This highly touted FDA-approved-source requirement is, however, in the words of one study, "a regulatory mirage." ^[176]

There are no specific requirements in FDA rules for protection of bottled water sources from pollution sources (such as setbacks from hazardous-waste dumps, industrial facilities, septic tanks, or underground gasoline storage tanks), nor are there any specific rules for disapproval of sources once they become contaminated. In fact, there are no requirements for bottlers or state or local authorities even to evaluate or document whether any such potential contamination sources may exist. In addition, in 1990, government investigators reviewing bottler records found that 25 percent of the bottlers audited had no documentation of source approval. ^[177]

This contrasts with requirements for city tap water. Under the 1996 SDWA amendments, states are required to conduct a source-water assessment for public drinking water supplies (i.e., tap water). ^[178] The assessment is required to delineate the boundaries of the assessment area that supplies the water system and to evaluate known or potential sources of contamination and the susceptibility of the drinking water source to contamination. ^[179] Millions of dollars in federal funding were made available to conduct these assessments.

In the case of bottled water source approvals, however, NRDC's investigation has noted cases in which the source of bottled water either was never assessed by authorities or the assessment overlooked important nearby contamination sources. In such cases, the source is anything but "protected" from contamination. Even in a state with a relatively well-developed bottled water program, like Massachusetts, the source-approval process apparently is essentially pointless. For example, as discussed in Chapter 3, the Millis well, in an industrial parking lot in Massachusetts near a state-designated hazardous-waste site, for several years supplied contaminated water to several major bottlers and was an approved source. ^[180] If even in an extreme case, such as the Ann & Hope well in Millis, the well meets the "approved source" requirement, the FDA rule appears to have no meaning. Indeed, in our review of scores of bottlers' files maintained by several states, we found no case in which source approval was denied or revoked. In the Millis Well Case, the state said it would allow continued use of the source, despite past contamination, if the water were subject to treatment; apparently the well is no longer used for bottling water.

4. Bottlers may violate FDA standards if the label notes that the water "contains excessive chemical substances."

The problem with FDA bottled water standards is not limited to the gaps in their coverage or lack of certified labs. Many people are stunned to learn that even if bottled water is more contaminated than FDA's standards would otherwise allow, FDA rules (and those of many states) explicitly still allow the water to be sold. The contaminated water may be marketed so long as it says on the label "contains excessive chemical substances" or "contains excessive bacteria" or includes a similar statement on the label. ^[181] For example, as discussed in the accompanying Technical Report, (print report only) the state of New Jersey found that Fuentes De Cutolo Spring Water contained nitrates at elevated levels that exceeded the FDA and state standards (as noted in our discussion of nitrates' health effects in Chapter 3 and the Technical Report (print report only), nitrates can cause blue-baby syndrome in infants if consumed at levels in excess of standards). Rather than taking an enforcement action, the state "requested that this firm either reduce the level of nitrate by treatment or change the product label to include a statement 'contains excessive nitrate'" on its label. ^[182]

In fact, in a 1996 Federal Register notice, FDA sent clear signals to the industry that if a bottler violates FDA standards, in some cases FDA is prepared to take no action so long as the bottle includes such a statement. Responding to industry concerns that bottled water that meets chemical-contamination standards in Europe might violate some proposed FDA rules, FDA pointed out that:

if a bottled water product...exceeds an allowable level for a particular contaminant...the bottler can still market that product, provided that the labeling bears a statement of substandard quality -- e.g., if it exceeds the allowable level for thallium, the labeling shall state either "Contains Excessive Thallium" or "Contains Excessive Chemical Substances".... Therefore, should a European or American bottled water product exceed the allowable levels of contaminants, it still can be marketed in the United States if its labeling bears the prescribed statement of those contents. ^[183]

FDA suggests that it may enforce against such labeled contaminated water if it finds that it is "injurious to health" and thus "adulterated" ^[184] -- but there is no requirement that such contaminated bottles even be reported to FDA, and we have been able to find no cases of FDA having taken any enforcement action against any such bottlers.

5. Bottlers are not required to report test results or violations and may dispose of records after two years; tap water suppliers must report results and retain records.

Under EPA rules, tap water suppliers must report their monitoring results and any drinking water standards violations that occur to EPA or, if the state has obtained formal EPA approval to exercise "primary enforcement authority," the water system must report to the state. ^[185] If there is a serious violation, it must be reported to the state within 48 hours. ^[186] The state then must report results and violations to EPA, ^[187] and EPA then posts all violations on the Web for easy public access. In addition, tap water suppliers must keep on hand their bacterial testing results for 5 years, and their chemical tests for 10 years, to allow effective EPA and state inspections. ^[188]

In contrast, FDA rules include no provision obligating a bottler to notify FDA or a state of test results, contamination problems, or violations, even in the case of contamination that could pose a serious health threat. FDA has refused to require such reporting when called upon to do so during rule-making proceedings. ^[189]

Answering both criticism of this lack of reporting and questions about how it can effectively track bottler compliance without reporting of test results, FDA said it "does not have the resources to review bottled water test results except during FDA plant inspections." ^[190] As noted below, however, such FDA inspections are quite rare (every four to five years or less frequently). Moreover, FDA requires bottlers to retain their testing records for just two years^[191] -- unlike the 5 year/10 year EPA tap water supplier requirement. ^[192] This means that since FDA inspections are so rare, many contamination problems may never come to FDA's attention, because the record of the event can be discarded before FDA ever reviews the bottler's records.

As GAO has pointed out, such record retention can be critically important "to allow regulatory officials to (1) review historical test data to verify that the tests were done, (2) gain insight into a particular or recurring problem, and (3) learn of and respond to contaminated water problems." ^[193]

This lack of reporting combined with other shortcomings in FDA's program pose serious problems for enforcement and compliance monitoring. For example, FDA does not maintain an inventory of water bottlers or shippers, so it often must rely upon state authorities for such information. ^[194] But state programs vary widely, with some having few if any resources dedicated to tracking bottled water (see the state programs section, later in this chapter.) Without an inventory of bottlers or reporting of testing results or violations, it is logistically difficult, to say the least, for FDA to adequately track bottler compliance.

6. Bottlers are not required to test water after storage, when it may have increased contamination levels, nor are they required to list the bottling dates for their water.

FDA's rules require weekly bacteria testing and annual chemical testing, but this testing is generally done of water at the bottling plant. ^[195] There is no requirement that bottlers test water after shipping it to stores or after storage. Moreover, FDA has refused requests to require bottlers to place a bottling date on their bottled water, or to require a label suggesting that consumers refrigerate their water after opening to retard bacterial growth.

This is problematic in light of the investigations discussed in earlier chapters of this report indicating that HPC bacteria, Pseudomonas aeruginosa, algae, and other microbes that may be present only at very low (or nondetectable) levels immediately after bottling can bloom and grow after bottling. The "FDA acknowledges that some bacteria can grow in bottled water, and that bottled water, unless treated in some manner, is not sterile." ^[196] But such post-bottling microbial-growth problems are missed under standard "at the bottling plant" testing under FDA rules.

Moreover, if there is no bottling date for bottled water, and no consumer warning to refrigerate after opening, the regrowth in the bottle could become substantial. FDA admits that "[a]dditional bacteria may enter a bottle of water with exposure to air" but argues that bottled water "is not a good source of nutrients for most microorganisms" so no precautions such as date of bottling or refrigeration warnings are needed. ^[197] As discussed at length in the Technical Report (print report only) on microbial contamination, however, there are several studies documenting regrowth of Pseudomonas and other organisms occurring in bottled water after bottling that make it difficult to accept this unsupportable FDA reassurance. ^[198]

Similarly, as discussed in Chapter 3 and the Technical Report (print report only), several plasticizers and other plastic reactants or by-products can migrate from bottles into the water with time. Some studies indicate a steady increase with time of certain cancer-causing and other contaminants in bottles as the bottle slowly leaches out the chemical into the water. Again, if the water is tested only immediately after bottling, such problems will likely never be detected.

FDA Places a "Low Priority" on Bottled Water: Resources Are Extremely Limited, Inspections and Enforcement Are Rare

FDA has repeatedly stated that bottled water is low on its priority list. FDA says that "bottled water products are a relatively low public health problem," ^[199] and "[i]n this program bottled water plants generally are assigned low priority for inspection....When compared to products such as low acid canned foods...bottled water products must take a back seat." ^[200]

Indeed, according to FDA staff estimates, the agency has dedicated just one half of a staff person (full-time equivalent) to bottled water regulation, and less than one to ensuring bottled water compliance. ^[201] Because of this low priority, water bottlers can expect to be FDA inspected on average every four to five years or less frequently. ^[202] GAO found that "FDA inspected about half of 410 domestic bottlers only once in 5-3/4 years." ^[203] FDA recently has confirmed that inspections are no more frequent today than they were in 1991, although FDA funds occasional state "contract inspections.". ^[204]

In 1995, FDA refused an IBWA petition asking for annual FDA inspections of bottlers, citing low priority and lack of resources. ^[205] As the GAO has pointed out, however, inspecting once every five years or less often is far too infrequent to detect certain possible problems. For example, contamination problems may come and go depending on conditions in the source water, on pumping patterns, bottling-plant operation and maintenance practices, etc. Since testing and other records are required to be kept only for two years, there is no requirement to report test results to FDA, and FDA inspects only once every four to five years or less often, it is quite possible that many contamination problems are never detected by FDA.

Moreover, GAO investigators found that when FDA does do inspections, often FDA relies upon the results of the bottlers' self-testing rather than doing independent testing of its own. Even when FDA does do independent testing, it often checks for just a handful of contaminants out of the scores for which FDA rules require monitoring. GAO found that FDA tested for five or fewer contaminants in 94 percent of the FDA tests they reviewed. ^[206] FDA staff recently admitted there likely has been no major change in testing and inspection practices since the GAO investigation. ^[207]

Finally, FDA does not inspect foreign bottlers, so the compliance of those bottlers with FDA testing and good-manufacturing-practice requirements is uncertain. ^[208]

State Bottled Water Programs Lack Resources and Regulatory Standards, and in Some Cases Are Virtually Nonexistent

State programs range from well developed to nonexistent

NRDC conducted a detailed survey sent to all 50 states' bottled water programs, summarized in Appendix C. As a result, we have learned that while some states, such has California, Massachusetts, New Jersey, Texas, and Washington have bottled water programs that are relatively well developed, other states have no or virtually no program. Most have not adopted the IBWA model code, some have not adopted all of FDA's standards, and most have few resources dedicated to implementing the program. This makes FDA's heavy reliance upon state programs subject to question.

States are under no legal obligation to adopt the FDA bottled water standards. In fact, FDA has no formal system to track the adequacy of state regulations, inspection results, enforcement, source-water approvals, or other aspects of state bottled water programs. In response to questions from NRDC, FDA could not answer even the most basic questions, such as how many states have adopted FDA standards, nor does FDA maintain its own inventory of all water bottlers. This means that often, if not most of the time, bottled water regulation falls to the states, some of which, as noted below, are ill equipped to take on this role.

State resources

The lack of state resources for bottled water is a major problem. Among the 50 states and the District of Columbia, 13 states told NRDC that they have no resources, staff, or budgetary allotments specifically earmarked to implement the state bottled water programs. ^[209] In addition, 26 states reported having less than one full-time staff equivalent (FTE) dedicated to running the state's bottled water program. Only seven states reported having one or more full-time staff people dedicated to implementing and maintaining the state's bottled water program. ^[210] This makes FDA's heavy reliance upon state programs problematic.

As is detailed in Appendix C, state bottled water programs range from being stricter than FDA's requirements in some areas (e.g., California, Georgia, Montana, New Jersey, New York, Pennsylvania, Texas and Vermont), to proudly proclaiming that they are less strict than federal rules. A few examples of states with less developed programs include:

• Alaska, which reports that it does not require bottlers to conduct annual testing for chemical and radiological contaminants^[211] (despite FDA rules requiring such annual monitoring.
  
  
• Arizona, which reported to NRDC that "the State of Arizona does not currently regulate the bottled water industry." ^[212] The state says local county health departments have some authority to do so, and that it relies on FDA to deal with interstate water.
  
  
• Delaware, which conducts no active regulatory oversight of the FDA's requirements, nor does it have a permit program. Delaware has no separate state code addressing bottled water and says it has no bottlers in the state.
  
  
• Illinois, which has no state certification or permitting process. Moreover, the source of bottled water is inspected by the state only upon request by the bottler (i.e, no mandatory testing of source waters). Occasionally, however, health inspectors may inspect bottlers as part of an inspection of an otherwise-regulated facility (such as a restaurant or hotel).
  
  
• Indiana, which does not have a separate state code regulating bottled water processing, does not certify sources and does not have a state permit or licensing program.
  
  
• Kansas, which has no separate state regulations and no permit program. In a recent telephone interview, a Kansas state official reported that "Kansas has no statutory authority to issue permits, licenses, or certificates for bottled water processors, plants, or distributors." ^[213]
  
  
• Missouri, which regulates microbiological contaminants in bottled water and inspects bottled water plants but does not regulate chemical and radiological contaminants -- despite FDA rules requiring such annual monitoring. ^[214]
  
  
• North Dakota, whose Health Department reported to NRDC that "State regulations are far less stringent tha[n] those administered by" FDA. The Health Department also reported that "no enforcement actions" have been taken by the state in the past four years, that "no documented violations or data [are] available," and that "very little, if any, bottled water is tested by our agency. I know of no other State agency that tests bottled water." ^[215] Additionally, the state does not require bottlers to submit source analysis prior to initiating bottling operations.
  
  
• Texas, whose bottled water program, while stronger overall than that of many states, has less than one FTE dedicated specifically to the state's bottled water program. Texas reports that there are currently more than 300 bottlers operating within its borders. ^[216]
  
  
• Utah, which does not currently approve sources and does not have a permitting program for water-bottling facilities.
  
  
• Virginia, which does not certify sources, nor does it have a permitting program. Virginia reports that it is not "empowered to permit or license." ^[217]

Thus, it is apparent that some states have put few if any resources into their bottled water program. FDA's reliance upon state programs to assure compliance is, in many states, misplaced.

There are noteworthy exceptions to our general finding that state programs lack the necessary resources and programs to justify FDA's reliance. Encouragingly, a handful of states seem to have placed a greater priority on making sure that bottled water is consistently safe, healthy and free of contaminants for consumers. In addition, some states, while not necessarily imposing strict and comprehensive bottled water programs across the board, have adopted small but significant advances that may help to improve bottled water protection at least somewhat.

States that have adopted at least some progressive regulatory innovations include:

• California, which has adopted stricter regulations for many contaminants than FDA, including lower allowable THHM levels and tougher disinfection rules, and has a fairly well developed regulatory program. Moreover, California citizens have adopted Proposition 65, a law that requires, among other things, that those doing business in the state must provide a clear and reasonable warning if they or their products expose people to toxic chemicals. This law applies to bottled water as well as to other consumer products.
  
  
• Florida, which reports that it has two full-time staffers dedicated to its bottled water program and has its Food Laboratory collect and analyze random samples of bottled water off retail food shelves. However, the state does not routinely publish the results of its testing to consumers.
  
  
• Louisiana, which samples end product every three months, from both in- and out-of-state bottlers. As in Florida, however, Louisiana does not publish its test results to inform consumers.
  
  
• Maine, which, in addition to following FDA labeling rules requiring that finished-product bottled water violating FDA standards must say so on the label, also requires that contaminants that exceed maximum contaminant levels (MCLs) in the source water be listed on the label. Although the state does not require that bottlers list analytical results on the labels (making this optional at the prerogative of the bottler), it does require that a bottler list on its label any altered water quality.
  
  
• Maryland, which requires that bottlers conduct an EPA primary drinking water analysis of its source.
  
  
• Massachusetts, which publishes an annual public report that summarizes the bottler-filed bottled water quality testing results. The report can be misleading, however, because in many cases it does not mention known contamination incidents.
  
  
• Mississippi, which tries to sample each bottled water product sold in the state on a monthly basis for E. coli. and other bacteria.
  
  
• Montana, which requires that all in-state bottlers become Public Water Systems and meet EPA drinking water standards prior to start-up.
  
  
• Nevada, which requires that a bacteriological analysis be submitted every week to the Department of Human Resources, Health Division, if a plant is in full operation.
  
  
• New Jersey, unique in its requirement that a bottler list a two-year expiration date (from time of bottling) on its label, also mandates by state statute that an annual enforcement/violation report be compiled and submitted to the state legislature. New Jersey also conducts a limited number of "spot checks" of bottled water sold and produced within the state.
  
  
• Ohio, which requires that any additives to bottled water be listed on labels.
  
  
• Texas, which in addition to having stricter standards and more frequent inspections than FDA, also requires source labeling and certification of operators under its unique Bottled Water Certification Program. Under the program, bottlers are required to attend training/awareness courses sponsored by the state and earn different "grade" levels (grade A being the most stringent) based upon number of classes attended and years in operation. Texas also requires that bottlers resubmit a water-quality analysis annually to an EPA certified lab in order to renew licenses (unless source is municipal).
  
  
• Vermont, which has more stringent testing regulations and labeling requirements than FDA. Vermont requires that the source, the name and address of the bottler, and finished-product levels of arsenic, lead, sodium, and nitrates be listed on bottled water labels.
  
  
• West Virginia, which has more stringent reporting requirements than FDA: Bottlers must test weekly for bacteriological contaminants and submit their reports to the state agency by the 10th of each month. Additionally, West Virginia requires that the source be protected from outside contamination at the point of discharge and the draw area.
  
  
• Wisconsin, which requires, by statute, publication of an annual bottled water quality analysis report. This report evaluates only about a dozen waters sold in the state, however. There are about 24 bottlers in Wisconsin and many more waters imported from out of state.

State regulatory programs, such as those just listed, that have attempted to innovate or to "put some teeth" into both federal and state regulations are to be applauded. Not all state regulatory agencies are provided the resources or legislative authority to implement all of the innovations just described, and many agencies are constantly being challenged to make less do more. Yet, several of the innovations require a relatively low investment of time and state funds, and could be adopted with minimal additional demands on state resources.

One good example of a low-cost, high-return regulatory innovation is the requirement adopted by several states that bottlers submit copies of state and/or federally mandated water-quality tests to the appropriate state agency on a weekly, monthly, or yearly basis rather than merely requiring that bottlers keep copies on hand at the plant. Similarly, additional contaminant disclosure labeling requirements to require public information about contaminants in the water, have a beneficial effect and carry out the public's right to know. Such requirements, while not compelled under federal regulations, would go a long way in flagging potential health risks early on, while at the same time would provide an obvious incentive for bottlers to remain in compliance with the regulations. Certainly, some of these or similar types of programs are worth consideration by other states when the payoffs are less risk to the consumer and more compliance with the law.

No guarantee of compliance with FDA requirements

Even in states that have adopted FDA standards, there is no assurance that the states are actively enforcing those standards. For example, Alaska has adopted bottled water standards that generally are equal to EPA drinking water standards, in addition to codifying IBWA and FDA standards. Curiously, however, the state of Alaska has unilaterally decided it will not require annual bottlers to conduct chemical and radiological contaminant testing as required under FDA's regulations. Calling such tests "expensive and not necessary," ^[218] Alaska has decided it will not require these tests. While it is commendable that the state of Alaska generally has adopted strict regulations for its bottled water, we fail to see the logic (or legality) in openly flaunting a critical portion of the FDA's bottled water regulatory requirements.

It is unclear how many states have unwritten policies of not enforcing part or all of their own or FDA's rules. Such disregard for a federal requirement is unsettling and sets a poor example for other states, which may, in the same spirit as Alaska, simply choose to disregard other vital parts of the federal requirements. FDA relies upon voluntary compliance with federal requirements and has dedicated no resources to auditing or evaluating state-program performance. Unfortunately, in light of the minimal FDA resources dedicated to the bottled water program, we cannot afford to allow the states to pick and choose which federal requirements they are willing to comply with.

Nonregulated bottled waters

State adoption of FDA regulations becomes especially important when one considers that even the FDA regulations for bottled water have huge gaps through which contaminated waters can easily flow. FDA says its rules do not apply to intrastate bottled waters (water that is bottled, sold, and distributed entirely within the borders of any one state), nor do they apply to seltzer water, carbonated water, flavored water, and certain other waters noted earlier. There are currently no specific standards (i.e., no required contaminant testing or water-quality standards) that cover the processing, testing, or distribution of these categories of bottled waters.

While many states have adopted their own standards to cover intrastate bottled waters, either by separate state code or by voluntarily extending the FDA regulations to intrastate bottlers, three states (Delaware, Indiana, and Kansas) and the District of Columbia have not adopted their own regulations to cover such water. Moreover, only 35 percent (18 out of 51 states and the District of Columbia) regulate seltzer, carbonated, and/or flavored waters under either the FDA standards or their own state standards. The undeniable conclusion from these statistics is that, although some states have taken the "extra" steps to ensure that all bottled water is subject to crucial contaminant testing (even where not required under federal law), many states have not. There remains an entire category of bottled water actively being distributed to and consumed by the general public that is not subject to any required testing at all in most states.

Source listing and labeling requirements

Only 14 states currently require source listing on the labels of bottled water products. ^[219] Other states reported having various other labeling requirements in addition to the FDA requirements, mostly aimed at prevention of misbranding. ^[220] Interestingly, Maine and Texas require bottlers to list contaminants if the source or end product exceeds maximum contaminant levels (MCLs). With the exception of the states just mentioned, no other states have any requirements for source or contaminant listing on the labels of bottled water beyond FDA requirements.

Few enforcement actions

FDA generally relies on the states to enforce federal bottled water regulations. Information gathered by NRDC over the last several years from FDA and state agencies charged with enforcing the federal regulations, however, indicates that few, if any, serious enforcement actions have actually been instituted by the states. Of the 50 states and District of Columbia, only about half^[221] report having taken any enforcement action in the past four years, and most of those were in the form of warning letters from the appropriate state agency requesting that bottlers come into compliance with regulatory requirements. Only a handful of states reported having to shut down bottlers or enforce involuntary recalls in the last four years.

Optimistically, the lack of enforcement actions could mean that all bottled water processors are virtually always in full compliance with all federal and state testing and health requirements. Yet experience and common sense, as well as our review of state records in some states that gave us access under freedom-of-information laws, point toward a different, less optimistic reality. The scarcity of state resources dedicated to implementation and enforcement of federal and state bottled water regulatory programs lends significant support to the suspicion that the lack of serious enforcement actions is due, in large part, to extreme shortages in state resources for enforcement purposes, rather than lack of violations.

Violation data "unavailable"

Unfortunately, it is nearly impossible to confirm or deny such suspicions. This is predominantly because data on the number and scope of bottled water violations are either not reported or are unavailable to the public in all but 10 of the states. ^[222] If such violation data were available, a truer picture of the enforcement-to-violation ratio could be compiled, by conducting a relatively simple comparison between the number and scope of enforcement actions in any given state with the number and scope of reported violations.

Without violation data, we are left in somewhat of a void when it comes to rating the quality of enforcement, having only half of the story on which to base our conclusions. Computerized databases would greatly facilitate both record keeping and public access to violation data, and, subsequently, increase accountability of violating bottlers and state enforcement divisions alike. Some states (such as Georgia, Missouri) are to be applauded for developing databases or working toward that end. Most states, however, are unable or unwilling to provide summaries of violations.

State permit programs

It is encouraging that most states report that they have developed and maintain a state permitting or licensing program for bottled water processors. State licensing programs can vary widely from state to state but serve an important function in the battle against compromised bottled water quality. State-issued permits can be a powerful regulatory tool (oftentimes the only enforcement tool used).

As one state official observed, state licensing programs "provide control and leverage both administratively and to the regulatory scheme." ^[223] Nearly all the states require that bottlers, prior to being issued a license or permit, submit a water quality analysis for both source and end product that is at least as stringent as the FDA requirements. While most permits must be renewed annually, some do not need to be renewed or have renewal periods of three or more years. Notably, California, New Hampshire, New Jersey, New York, Ohio, Rhode Island, Texas, and West Virginia require that a water-quality analysis be resubmitted every year as a prerequisite to license renewal. Yet, even though state licensing is one of the few tools states have at their disposal with proven compliance-forcing clout, nine states and the District of Columbia have not adopted permitting or licensing programs for bottled water processors (Delaware, Illinois, Indiana, Kansas, Michigan, North Carolina, South Dakota, Utah, and Virginia).

State programs may bend to bottlers' political influence

In addition, even a state that has a well developed program apparently may bend to political pressure from major bottlers. For example, in Massachusetts, Dr. Elizabeth Bourque, a biochemist who for many years ran the state's bottled water program, made a name for herself as an aggressive bottled water regulator.

As noted earlier, the Ann & Hope company's well in Millis, which provided water for several brands of bottled water, became contaminated with industrial chemicals, including trichloroethylene at a level above EPA and FDA standards. Dr. Bourque insisted that strict controls be imposed. ^[224] She also demanded that when a product from major bottlers, such as Perrier's Poland Spring water, contained high levels of HPC bacteria or chlorine, that action be taken. ^[225]

After many such aggressive interventions, Dr. Bourque was asked by her supervisors to stop working on these important problems and to instead focus on other work. She did not relent. However, after industry complaints to the Massachusetts Department of Public Health (MDPH) management, and a December 5, 1996, meeting of Nancy Ridley, MDPH Assistant Commissioner, attorneys from a blue-chip Washington, D.C., law firm (representing Perrier), and an official from a bottler that used Ann & Hope water, Dr. Bourque was reassigned to other duties. ^[226] She also received a written "gag order" that prohibited her from speaking about bottled water to the press, water-analysis labs, federal, state, or local agencies, or bottlers. ^[227] She and the union that represents state employees protested, alleging that the reassignment was punitive, but got nowhere. ^[228] State officials maintain that the reassignment was not punitive and was unrelated to any discussions with bottled water companies. Dr. Bourque recently retired.

An investigation by Senator Cheryl Jacques, a state senator who represents Millis, ensued. Senator Jacques' request for all state records relating to the Ann & Hope affair was responded to incompletely, with several key documents apparently not provided to the senator. ^[229]

It is difficult to know or to document how widespread the bottled water industry's political arm-twisting may be. Still, it appears clear that even in states with relatively comprehensive programs for bottled water, there may be serious limitations to state regulators' ability to vigorously implement the law.

Conclusions about state bottled water programs

A close look at the results of the NRDC surveys of states' bottled water programs makes it difficult to share FDA's confidence in the states' ability to ensure compliance with federal requirements, especially when some states lack even rudimentary permit programs. The reality is that, with few exceptions, state programs lack the necessary resources to provide adequate oversight and enforcement of the state and federal regulatory scheme.

By and large, most state programs appear to be afterthoughts, tacked onto the backs of other state regulatory programs, with little, if any, staff and resources dedicated to ensuring acceptable, healthful bottled water quality. Without the deterrent of consistent, tough rules and meaningful enforcement, water bottlers have little incentive to comply with either federal or state requirements.

Our review of bottled water quality in previous chapters suggests that some bottled water is not of the highest quality. It is likely that a significant amount of bottled water is being consumed without having been subjected to proper and adequate quality testing, putting consumers' health at potential risk. This might not be occurring if states in fact had sufficient resources dedicated to bottled water programs. Moreover, even in states with resources dedicated to bottled water, such as Massachusetts, it is important that meaningful outside oversight take place so powerful political interests or bottlers cannot bend the state agencies to their advantage.

Voluntary Industry Standards, While Commendable, Are No Substitute for Enforceable Health Protection Standards

The International Bottled Water Association (IBWA) has long sought to encourage the industry (particularly the self-proclaimed 85 percent of the industry IBWA claims as its members) to comply with the IBWA model code, and to accept annual inspections by IBWA's contractor NSF International.

While these voluntary industry efforts are commendable, they cannot be viewed as an effective substitute for a strong and enforceable federal regulatory program. IBWA itself seems to have recognized this fact in that it has often petitioned FDA to adopt the IBWA Model Code and other important regulations.

The problems with FDA's and the industry's heavy dependence and faith in the effectiveness of the IBWA voluntary standards are many:

• Voluntary standards apply only to those who agree to them--that is, members of the industry who choose to be IBWA members. By IBWA's count, about 15 percent of the industry does not belong to the organization.
  
  
• Industry members who choose to leave IBWA to avoid compliance with the IBWA standards suffer no real consequence.
  
  
• Many companies bottle water (such as seltzer, sparkling, or other water) that is not covered under the narrow definition of "bottled water" adopted by FDA rules and the IBWA Model Code. Thus, these waters are exempt from the voluntary industry standards and are not subject to the specific FDA contaminant standards that apply only to "bottled water" (as that term is narrowly defined).
  
  
• While some states (according to IBWA, about 16) have adopted the IBWA standards as binding and enforceable, most states have not done so.
  
  
• The inspection results after NSF inspections are not shared with regulators or the public, so it is impossible to determine how effective these inspections and IBWA standards truly are.

Thus, while the voluntary industry efforts are helpful, they cannot be a substitute for regulatory controls.

Chapter Notes

4a. Some observers have noted that all of the bottled water sold in the United States today is part of a stream of interstate commerce that begins with the extraction of the raw material for the bottles, often out of state, continues with the manufacture of the bottles, labels, caps, and shipping materials, moves on to the bottling facilities and the water extraction itself, the shipping of the water, and ultimately the sale of the water. Each of these steps in producing, packaging, and shipping water generally involves interstate commerce, and individuals who buy water bottled and sold in one state may be from out of state. In addition, any problem with the water (such as illnesses) clearly could directly affect interstate commerce. Interestingly, the IBWA has implicitly argued that FDA's jurisdiction extends to intrastate sales of bottled water. At a congressional hearing at which the inapplicability of FDA rules to intrastate sales was noted, IBWA's then-CEO said:

a statement was made this morning which might be confusing, and that is that most bottled water is not in interstate commerce. To the contrary, most bottled water is, because most of the products that are used in the bottled water plants, the bottles, the resin, the coolers, the caps, and labels all come from somewhere else, so in the strictest interpretation, interstate commerce is involved in just about all of our products.

Statement of William Deal, CEO, IBWA, in "Bottled Water Regulation," Hearing of the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, Serial No. 102-36, 102nd Cong., 1st Sess., p. 107 (April 10, 1991). Therefore, to the extent FDA has interpreted its jurisdiction over bottled water to include only water that crosses state boundaries, some have argued that FDA's interpretation is unduly narrow.

4b. Acrylamide and epichlorhydrin are chemicals sometimes used in drinking water treatment. EPA requires that any public water system using these chemicals must meet a "treatment technique" intended to ensure safe use of these chemicals. FDA has adopted no such requirement.

4c. 40 C.F.R. § 141.30. These tap water monitoring requirements (except for THMs) can sometimes be reduced in frequency for some small systems, or others that the state finds have been demonstrated not to be vulnerable, and that did not detect the contaminant in initial rounds of monitoring. See 40 C.F.R. §§ 141.24 & 141.61(a); see also Safe Drinking Water Act § 1418 (granting monitoring relief in certain cases to small public water systems).

4d. Both EPA and FDA require annual or less frequent testing for most inorganic contaminants. see FDA rules at 21 C.F.R. § 165.110, and EPA rules at 40 C.F.R. § 141.23(c). Additionally, Congress mandated in 1996 that unless FDA issued standards for nine contaminants (antimony, beryllium, cyanide, dioxin, diquat, endothall, glyphosate, nickel, and thallium) by August 6, 1998, EPA's tap water standards for these chemicals (including testing requirements) would automatically apply to bottled water. In May 1998, FDA issued a direct final rule stating it would apply EPA tap water standards for these contaminants in response to this mandate. 63 Fed. Reg. 25764 (May 11, 1998). That rule said, however, that rather than tracking EPA's tap water testing regime, FDA would set the monitoring frequency at once per year (instead of following EPA's rules requiring quarterly testing for some organics, and annual or sometimes less frequent testing for inorganics). Because water bottlers objected to some of these monitoring requirements as burdensome, FDA stepped back, saying it could not finalize the monitoring provisions in light of "significant adverse comments," and instead allowed the law to automatically impose the monitoring by the EPA tap water rules. The EPA (and now FDA) testing rules also allow waivers -- a provision FDA has not yet explained whether it will use. Thus, how FDA intends to implement the monitoring requirements for these contaminants is murky. See 63 Fed. Reg. at 42198-99 (August 6, 1998).

Report Notes

103. Statement of William Deal, CEO, IBWA, in "Bottled Water Regulation," Hearing of the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, Serial No. 102-36, 102nd Cong., 1st Sess., p. 108 (April 10, 1991).

104. Ibid. p. 112.

105. IBWA, "Frequently Asked Questions About Bottled Water," (available at www.bottledwater.org/faq.html), (printed 11/20/1998).

106. Ibid. (emphasis added)..

107. FFDCA § 410, 21 U.S.C. § 349 (1995); later amended by § 305 of the SDWA Amendments of 1996, Pub. L. 104-182 (August 6, 1996).

108. Ibid.

109. Senate Environment & Public Works Committee, Safe Drinking Water Act Amendments of 1995: Report of the Committee on Environment and Public Works, United States Senate, on S. 1316, Report No. 104-169, 104th Cong., 1st Sess., p. 96 (November 7, 1995).

110. "Bottled Water Regulation," Hearing of the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, Serial No. 102-36, 102nd Cong., 1st Sess. (April 10, 1991); General Accounting Office, Food Safety and Quality: Stronger FDA Standards and Oversight Needed for Bottled Water, GAO/RCED-91-67, pp. 16-17 (March 1991).

111. FFDCA § 410, 21 U.S.C. § 349 (1997).

112. Ibid.

113. The FDA bottled water rules are codified at 21 C.F.R. parts 129 and 165 (1997).

114. Personal Communication with Terry Troxel and Shellee Davis, FDA, September 18, 1997.

115. Personal Communication with Ron Roy, FDA, compliance programs, November 20, 1998.

116. See, e.g., NRDC, Think Before You Drink (1993); NRDC, Victorian Water Treatment Enters the 21st Century (1994); NRDC, The Dirty Little Secret About Our Drinking Water (1995); NRDC, You Are What You Drink (1995), NRDC, USPIRG, and Clean Water Action, Trouble on Tap (1995) .

117. Statement of Frank Shank, Director, FDA Center for Food Safety and Applied Nutrition, reprinted in, "Bottled Water Regulation," Hearing of the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, Serial No. 102-36, 102nd Cong., 1st Sess. 65, p. 75 (April 10, 1991).

118. FDA, "Beverages; Bottled Water: Final Rule," 60 Fed. Reg. 57,076, at 57120 (November 13, 1995).

119. Ibid., p. 57, 120 (citing FFDCA §§ 301 & 304, 21 U.S.C. §§ 331 & 334).

120. General Accounting Office, Food Safety and Quality: Stronger FDA Standards and Oversight Needed for Bottled Water, GAO/RCED-91-67, pp. 16-17 (March 1991).

121. FDA Regulations, 21 C.F.R. § 165.110(a).

122. Personal Communication with Terry Troxel and Shellee Davis, FDA, September 18, 1997.

123. See California Health and Safety Code § 111070(a); see also Appendix C (summarizing state programs and noting whether they regulate seltzer, etc. as bottled water).

124. Anon., "1996 Alternative Beverages: Still Water Supply Up Sharply, Perrier, Coke, Pepsi, and Suntory Gain Share, Beverage Digest (April 25, 1997), (www.beverage-digest.com/970425.html), (printed 9/25/1997). (In 1996, there reportedly were 731 million cases of still waters-- some of which may have been exempt also because they were labeled "filtered water," etc., -- and 152.2 million cases of sparkling water.)

125. Personal Communication with Terry Troxel and Shellee Davis, FDA, September 18, 1997.

126. FFDCA § 410, 21 U.S.C. § 349 (1997).

127. Interview with Terry Troxel, FDA, September 18, 1997.

128. 40 C.F.R. § 141.63.

129. See, 21 C.F.R. § 165.110(b)(2).

130. 21 C.F.R. § 165.110(b)(2).

131. 58 Fed. Reg. 52042, at 52045 (October 6, 1993).

132. Personal Communication with Henry Kim, FDA, September 18, 1997.

133. 40 C.F.R. §§ 141.72(a)(4) & (b)(3).

134. 58 Fed. Reg. 52042, at 52047 (October 6, 1993), (emphasis added).

135. 40 C.F.R. § 141.21. However, under EPA's rules, however, smaller tap water systems can test less frequently--so systems serving under 4,100 people can test once a week or less often for total coliform bacteria. Ibid.

136. 21 C.F.R. § 129.80(g)(1).

137. FFDCA § 410, 21 U.S.C. § 349 (1997).

138. 40 C.F.R. § 141.72.

139. 21 C.F.R. § 165.110.

140. 21 C.F.R. § 165.110(b)(3)(i); under a negotiated rule to be issued in late 1998, the turbidity standard will drop to a maximum of 1 NTU, with a 95 percentile level of 0.3 NTU. 63 FED. REG. 69477 (December 16, 1998).

141. 40 C.F.R. § 141.73.

142. Studies show a clear link between drinking water turbidity and illnesses. See, R.D. Morris, E. N. Naumova,. and J.K. Griffiths, "Did Milwaukee Experience Waterborne Cryptosporidiosis Before the Large Documented Outbreak in 1993?" Epidemiology vol. 9, no. 3 , pp. 264-270 (May 1998). For example, in the Milwaukee Cryptosporidium outbreak turbidity increases were the only indicator of a water quality problem. Even with turbidity monitoring in Milwaukee, illnesses already had started by the time a spike in turbidity was noticed and action taken. See, e.g. , W. R. MacKenzie, et al., "A Massive Outbreak in Milwaukee of Cryptosp