Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is amending its bottled water regulations to require that bottled water manufacturers test source water for total coliform, as is required for finished bottled water products, and to require, if any coliform organisms are detected in source water, that bottled water manufacturers determine whether any of the coliform organisms are
This rule is effective December 1, 2009. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of December 1, 2009.
Lauren Posnick Robin, Center for Food Safety and Applied Nutrition (HFS–317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–1639.
In the
FDA proposed a number of changes to part 129. FDA proposed to amend § 129.35(a)(3)(i) to require that bottled water manufacturers that obtain their source water from other than a public water system (PWS) test their source water at least weekly for total coliform, and that when source water is total coliform positive, that they conduct follow-up
FDA proposed a number of changes to part 165. FDA proposed to add § 165.110(b)(2)(i)(B) to indicate that if
FDA issued the proposed rule in response to EPA's issuance of a new National Primary Drinking Water Regulation (NPDWR), the Ground Water Rule (GWR), in the
The agency received 19 responses, each containing one or more comments, to the September 17, 2008, proposal. The comments were from trade associations, industry, a law firm, an environmental advocacy organization, and consumers. The comments generally supported the proposed rule. Some comments addressed issues that are outside the scope of the proposed rule (e.g., testing of water in general; testing for agricultural chemicals, industrial chemicals, and parasites such as
(Comment 1) One comment suggested FDA make clear that when a bottler conducts secondary
(Response) FDA agrees that the sampling site where an
FDA notes that some manufacturers combine source waters from multiple sources. Weekly microbiological testing is required for each separate source in use by the plant. If
(Comment 2) One comment stated that FDA should join EPA in mandating sanitary surveys as an effective measure of risk reduction. The comment also stated that sanitary surveys can identify and eliminate risks or weaknesses which weekly water testing cannot, such as cracks in sanitary seals around wells. Finally, the comment stated that if the lack of a primacy program arrangement with the States is the real reason for the lack of a sanitary survey requirement, FDA should look into establishing a primacy program arrangement, such as having the same State agencies and inspectors, which EPA trains and uses to conduct sanitary surveys of public water sources, also conduct sanitary surveys of bottled water sources.
(Response) FDA disagrees with this comment. Although FDA does not have a primacy program arrangement with States to conduct sanitary surveys, FDA believes that the requirement for weekly source water testing for total coliform (and for
While sanitary surveys may help identify potential risks for fecal contamination in source water, such as cracks in sanitary seals, actual fecal contamination of source water is identified by source water testing. This rule requires weekly source water testing for total coliform, with
Therefore, FDA believes that the proposed requirement for weekly source water testing for total coliform (and for
(Comment 3) A number of comments questioned the proposed requirements for frequency of testing of source water and/or finished products in part 129. Some comments suggested that EPA requires more samples than FDA, while citing different numbers for how many samples EPA requires. Another comment stated that weekly testing would not detect intermittent contamination, and that daily testing would be more appropriate, as evidenced by FDA's proposal that a source previously found to contain
(Response) FDA disagrees with these comments on the proposed requirements for the frequency of testing of source water and finished products. FDA does not believe that it is appropriate to compare the number of tests required by EPA for total coliform in PWSs to the number of tests required by FDA for total coliform in source and finished bottled water. To monitor the microbiological safety of their distribution systems, PWSs must take samples throughout their distribution systems and in a pattern that is representative of the distribution system. Bottled water plants do not have distribution systems and monitor finished bottled water products from a filling line. Therefore, FDA does not believe that the number of tests required for a PWS distribution system serving a large geographical area is comparable to the monitoring required for a bottled water manufacturing plant.
In this rule FDA is amending its bottled water regulations to require that bottled water manufacturers test source water at least weekly for total coliform, as is required for finished bottled water products, and to require, if any coliform organisms are detected in source water, that bottled water manufacturers determine whether any of the coliform organisms are
Also, FDA previously established additional microbiological testing requirements to help ensure the safety of finished bottled water products. The CGMP regulations for bottled water in § 129.80(a) state that product water samples shall be taken after processing and prior to bottling by the plant and analyzed as often as is necessary to assure uniformity and effectiveness of the processes performed by the plant. FDA also requires in § 129.80(f) that at least once each 3 months, a bacteriological swab and/or rinse count should be made from at least four containers and closures selected just prior to filling and sealing. All of the samples are required to be free of coliforms, and no more than one of the four samples may exceed more than one bacteria per milliliter of capacity or one colony per square centimeter of surface area.
For these reasons, FDA believes that the frequency of testing of source water and finished products, as set forth in the new and revised requirements under part 129, will ensure that FDA's standards for the minimum quality of bottled water, as affected by fecal contamination, will be no less protective of the public health than those set by EPA for public drinking water.
(Comment 4) One comment stated that the requirement that bottled water manufacturers “take and analyze at least once a week a representative sample from a batch or segment of a continuous production run for each type of bottled drinking water produced during a day's production” in § 129.80(g)(1) fails to specify that the day's production that is to be sampled must have been produced during the week in question.
(Response) FDA believes that § 129.80(g)(1) requires that the sample mandated to be taken “at least once a week” must be taken from bottled water produced during the week it is sampled. It would not make sense to interpret this provision to allow otherwise in light of the clear intent to mandate regular, timely testing. Further, FDA is not aware of any bottlers who have understood the provision as not requiring the sample to have been produced during the week in question. Therefore, FDA does not believe it is necessary to make any changes to § 129.80(g)(1) based on this comment.
(Comment 5) One comment suggested that FDA establish specific requirements, like the EPA GWR, as to how bottlers should correct
(Response) FDA does not agree that it is necessary to include specific requirements in its regulations for rectifying or eliminating the cause of
(Comment 6) One comment suggested that FDA update the reference in proposed § 165.110(b)(2)(ii) to the most current version of “Standard Methods for the Examination of Water and Wastewater.”
(Response) FDA agrees that the most current edition should be cited in the final rule. In the proposed rule, FDA cited the 20th Edition of “Standard Methods for the Examination of Water and Wastewater.” However, there is a 21st Edition of “Standard Methods for the Examination of Water and
(Comment 7) One comment suggested the need for guidance on demonstrating comparable results when labs are comparing other methods to the MTF and MF methods. The comment further recommended that an established or pre-agreed-upon protocol should be used to prove comparability.
(Response) FDA does not believe that such guidance is necessary. As stated in the proposed rule (73 FR 53775 at 53782), bottlers can use different methods approved by the government agency or agencies having jurisdiction as long as their methods give comparable results to the methods used by FDA. Laboratories routinely adopt new analytical methods and have standard practices to follow for validating the performance of these methods and for comparing the sensitivity, accuracy, and precision of the new methods to currently used methods. These practices, along with the information provided by FDA on allowable levels of
(Comment 8) Several comments recommended that FDA consider a test result for
(Response) FDA agrees that a presumed positive test result for
As noted in the proposed rule, bottlers can use methods other than the MTF and MF methods to analyze water for total coliform and
(Comment 9) One comment stated that not all strains of
(Response) FDA agrees that not all strains of
In addition, as noted in the GWR, while fecal indicators typically are not harmful when ingested, their presence demonstrates that there is a pathway for pathogenic viruses and bacteria to enter ground water sources (71 FR 65574 at 65576). Therefore, it is not necessary to test for specific pathogenic strains to demonstrate that there is a pathway for pathogenic viruses and bacteria to enter ground water sources. Confining testing to a few specific pathogenic strains would be less effective at detecting fecal contamination than the broader
(Comment 10) One comment suggested that FDA adopt EPA's maximum contaminant level goals (MCLGs) as enforceable standards for chemical and microbiological contaminants in bottled water.
(Response) FDA notes that with the exception of fecal contaminants, this comment is outside of the scope of this rulemaking. MCLGs are unenforceable health goals established by EPA. EPA establishes enforceable standards for contaminants in drinking water in the form of maximum contaminant levels (MCLs) or treatment techniques (TTs). The SDWA (section 1412(b)(4) (42 U.S.C. 300g-1(b)(4))) requires EPA to set MCLs and TTs as close to the MCLGs as is feasible, with feasibility including technical and economic considerations. Section 410(b)(3)(A) of the act provides that an FDA regulation issued in response to an EPA MCL shall establish an MCL for the contaminant in bottled water which is no less stringent than the MCL provided in EPA's NPDWR. Likewise, section 410(b)(3)(B) of the act provides that an FDA regulation issued in response to an EPA TT shall be no less protective of the public health than the TT required by EPA's NPDWR. Therefore, FDA's response to NPDWRs is based on the legally enforceable MCLs and TTs, as provided for in the act.
(Comment 11) Several comments suggested that FDA require companies to disclose source information on bottled water labels. One comment said that there are ground water sources and surface water sources that are fouled by fecal pollution or other contaminants, and that public disclosure, on the bottle label, of the precise location of the water withdrawal site, of potential contamination of source water, or of pollutants in bottled waters will provide consumers with the evidence on which to make the decisions to purchase the product that would best suit their needs and the needs of their families.
(Response) FDA disagrees that it should require disclosure of source information as part of this rulemaking. FDA addressed the issue of source disclosure in the final rulemaking establishing a standard of identity for bottled water (§ 165.110(a)) (60 FR 57076 at 57104, November 13, 1995). FDA noted that under section 201(n) of the act (21 U.S.C. 321(n)), the agency must consider whether specific water source labeling information is a material fact whose nondisclosure will render the labeling misleading. FDA concluded that the specific name of the source is not material to ensure the safety of the product, given the requirements for source approval and operation in §§ 129.3(a) and 129.35(a)(1). FDA believes that the specific name of the source is not material to ensure the safety of the product from fecal contamination, in light of the requirements cited above and those added by this rule.
For this reason, FDA is not making any changes in response to these comments.
(Comment 12) Several comments suggested that FDA require bottled water companies to disclose test results for
(Response) FDA disagrees that it should require companies to routinely disclose test results for
Likewise, routine public disclosure of test results for
(Comment 13) One comment requested that FDA limit the applicability of the proposed rule to bottled water manufacturers that use ground water, noting that FDA modeled its proposed rule after the EPA GWR, which expressly limits its application to PWSs that use ground water. The comment also states that if FDA intends to regulate manufacturers that use surface water, it should adopt the analogous provisions of EPA's regulations in 40 CFR part 141, subparts C and H, which were designed specifically for surface water PWSs, and which are based on filtration and disinfection requirements rather than FDA's proposed requirements for an
(Response) FDA disagrees with the comment that it should apply this rule specifically to bottled water manufacturers that use ground water, that any FDA requirements for bottled water manufacturers that use surface water should be modeled after EPA's regulations for surface water PWSs, and that FDA should not adopt its own source and testing requirements for bottled water because EPA has different requirements for surface water PWSs. The application of this rule to all bottled water manufacturers is consistent with the adulteration provisions in section 402(a)(3) and (a)(4) of the act and with FDA's obligations under section 410 of the act. Specifically, under section 410(b)(1) of the act, FDA is required to respond to EPA's issuance of an NPDWR for a contaminant in drinking water by issuing a standard of quality regulation for that contaminant in bottled water, or make a finding that such a regulation is not necessary to protect the public health because the contaminant is contained in water in PWSs but not in water used for bottled water. Section 410(a)(b)(2) of the act also provides that a standard of quality regulation issued by FDA shall include monitoring requirements that the agency determines to be appropriate for bottled water.
In this rule, FDA is responding to an EPA NPDWR on fecal contamination in ground water. Fecal contamination can be found in surface water as well as ground water. Therefore, FDA believes that it is appropriate for it to respond to EPA's issuance of a NPDWR on fecal contamination in GWSs by establishing a regulation that will apply to all manufacturers of bottled water. As FDA explained in the proposed rule, “[T]he potential for fecal contamination addressed in the EPA GWR also exists for ground water sources used for bottled water. The potential also exists for bottled water products from ground water sources to be contaminated during processing and for bottled water products from other sources to be contaminated from source water or during processing. Therefore, FDA is proposing to require that source water currently subject to weekly microbiological testing be analyzed specifically for total coliform * * *.” (73 FR 53775 at 53779 through 53780). FDA notes that this rule is consistent with its regulatory approach, which has not been to establish separate regulations for ground water and surface water sources under parts 129 and 165.
In response to the comment's contention that the microbiological source testing and rectification requirements of this rule are not necessary for manufacturers that use surface water because microbiological contaminants are removed during treatment processes, FDA emphasizes that all bottled water products are subject to existing requirements related to the water supply. FDA's CGMP regulations for bottled water define “an approved source” as “a source of water and the water therefrom * * * 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” (§ 129.3(a)). The CGMP regulations require that the product water supply be of a “safe, sanitary quality” (§ 129.35(a)(1)). FDA does not consider source water containing
One existing exemption to the microbiological testing requirement is for source water from PWSs. As explained in the final rule establishing this exemption, PWSs are subject to EPA regulations to ensure the safety of public drinking water, including water from surface sources (60 FR 57076 at 57111). In this case, FDA considers the source water for bottling to be the treated water from the PWS, not the original surface water source from which the PWS drew its water. Therefore, this rule's requirement for coliform and, potentially,
In response to concerns regarding the rule's impact on manufacturers that use surface water, FDA noted in the proposed rule that 70 to 75 percent of bottled water manufacturers use ground water (73 FR 53775 at 53779). FDA believes that the vast majority of the remaining manufacturers obtain their source water from PWSs, rather than from surface water sources, based on information provided by industry (66 FR 35439 at 35440 through 35441, July 5, 2001). FDA also notes that this comment did not provide any specific information identifying manufacturers using surface water that might be affected by the rule. For these reasons, FDA is unaware of evidence of any bottled water manufacturers using surface water directly from a surface water source that would be negatively affected by this rule, e.g., manufacturers using sources that are potentially contaminated with
For the reasons summarized above, FDA is not making changes to the final rule in response to this comment.
The comments to the September 17, 2008, proposal (73 FR 53775) supported most of the provisions that FDA is adopting in this final rule. After review and consideration of the comments received in response to the September 17, 2008, proposal, FDA concludes that it should amend part 129 and part 165 as set forth in the proposed rule but with the specific modifications to the proposed regulation discussed in this document. For the purposes of this final rule, certain changes, in addition to those discussed in this document, were made for editorial purposes, clarity, and consistency only. These changes do not modify any matter of substance.
Therefore, FDA is amending parts 129 and 165 to provide the following:
• Bottled water manufacturers that obtain their source water from other than a PWS must test their source water at least weekly for total coliform, and if that source water is total coliform positive, must conduct follow-up testing to determine whether any of the coliform organisms are
• Source water found to contain
• Before a bottler can use source water from a source that has tested positive for
• Bottlers must maintain records of corrective measures taken to rectify or eliminate
• If any coliform organisms are detected in weekly total coliform testing of finished bottled water, follow-up testing must be conducted to determine whether any of the coliform organisms are
• Section 402(a)(3) of the act, in addition to section 402(a)(1), may apply as a basis for adulteration (§ 129.35(a)(4)(iv));
• Analyses conducted to determine compliance with the standards for microbiological quality for total coliform and
• If
As a result of these amendments to parts 129 and 165, upon the effective date of this final rule, December 1, 2009, any source water containing
The agency has previously considered the environmental effects of this rule as announced in the proposed rule. No new information or comments have been received that would affect the agency's previous determination that there is no significant impact on the human environment and that an environmental impact statement is not required.
FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601–612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104–4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is not a significant regulatory action under the Executive order.
The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the costs per entity of this rule are small, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $130 million, using the most current (2007) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.
This final economic impact analysis revises the analysis set forth in the proposed rule (73 FR 53775) in response to comments received. Except as indicated below, the analysis in this final rule is the same as the analysis of the proposed rule.
FDA did not receive any comments on the need for regulation in the analysis of the proposed rule. Under section 410 of the act, FDA is required to respond to the GWR published by EPA by issuing its own standard of quality regulation for bottled water that is no less protective of the public health than the treatment techniques adopted by EPA in the GWR, unless it makes a finding that such additional regulations are not necessary to protect the public health. EPA published the GWR, in part, because data indicated that GWSs are susceptible to fecal contamination. Prior to the GWR, there were no Federal regulations requiring monitoring or disinfection of ground water sources or requiring corrective action when fecal
EPA determined that there is the potential for ground water to be contaminated with pathogenic bacteria or viruses, or both, and that the presence of fecal indicators can demonstrate a pathway for pathogenic enteric bacteria and viruses to enter GWSs. Ground water sources supply water for 70 to 75 percent of all U.S. bottled water products (Ref. 2). Based on EPA's findings in the GWR, FDA concludes that the potential for fecal contamination that exists for PWS ground water sources regulated by EPA's GWR also exists for bottled water using ground water sources. The potential also exists for bottled water products from ground water sources to be contaminated during processing and for bottled water products from other sources to be contaminated from source water or during processing.
Dun's Market Identifiers database lists 378 U.S. establishments under North American Industry Classification System (NAICS) code 312112 Bottled Water Manufacturing (69 FR 70082 at 70084, December 2, 2004). These 378 establishments correspond to 318 firms. Because a firm may own more than one establishment and each establishment may be a source, a bottling plant or both, this analysis will assume that each establishment corresponds to one source. Foreign bottled water establishments that produce and export their bottled water products for consumption in the United States will have to meet the same FDA requirements as domestic establishments. FDA is aware of at least 35 major brands of bottled water that are imported into the United States. When sales of a particular brand constitute a significant portion of the market share for this industry, then the brand is considered a major brand. If each imported brand corresponds to one foreign establishment, then an additional 35 foreign establishments will also be affected, giving a total of 413 establishments covered by this rule (Ref. 3). Because FDA assumes that each establishment is equivalent to a single water source, we estimate that 413 bottlers, both domestic and foreign, will be covered by this regulation. FDA received no comments on these estimates. However, in response to a comment on sampling after an
FDA evaluated three regulatory options in the analysis of this rule:
Several comments recommended that FDA consider an
In evaluating the testing costs of the proposed rule, FDA based its estimates on EPA's GWR estimates for testing costs. At least some of the methods approved by EPA in the GWR include confirmatory testing for the fecal indicator organism. Therefore the costs of confirmatory testing are already included in the overall testing cost estimates used by EPA. Thus, the estimated testing costs in the economic impact analysis of the proposed rule remain the same for the economic impact analysis of this final rule.
Bottlers that obtain their water from PWSs are not required to conduct microbiological testing of their source water under the CGMPs (§ 129.35(a)(3)(i)). FDA considered removing this exemption. This would have the advantage of requiring all bottlers to conduct the same tests (i.e., to test their source water for total coliform) and to conduct follow-up testing for
1. Require that source water currently subject to weekly microbiological testing be analyzed specifically for total coliform;
2. Require follow-up testing for
3. Require bottlers, in the event the source water tests positive for
1.
2.
3.
Finished bottled water products that test positive for
For purposes of this analysis, FDA assumes that 75 percent of domestic bottled water establishments obtain their water directly from sources other than a PWS and that the other 25 percent obtain their water from PWSs (66 FR 35439 at 35440 through 35441). FDA is assuming that all 35 foreign producers that export bottled water to the United States obtain their water from other than a PWS and are currently testing their sources for total coliform. As mentioned previously, FDA assumes that for all domestic and foreign producers, one establishment corresponds to one source. Thus, we estimate that 284 (75 percent) of 378 domestic establishments and all 35 foreign bottled water establishments (284 + 35 = 319) whose products are consumed in the United States obtain their water from other than a PWS. Based on this estimate, we further surmise that all 319 establishments are already conducting total coliform testing of their source water. And approximately 25 percent of the estimated total of 378 domestic bottled water establishments (approximately 95) obtains their water from a PWS.
Table 1 of this document covers
For in-house laboratories, the laboratory materials cost per sample is estimated to be $8.95 and the labor cost to be $21.44 for 1 labor hour per sample (one-half hour for collecting and handling the sample and another half hour for conducting the analysis). For an independent commercial laboratory analysis, the test cost per sample would include a shipping and commercial analysis fee of $74.80 and a labor cost of one-half hour to collect the sample and arrange for delivery to the laboratory.
FDA is not aware of how many potentially affected establishments will either use in-house testing facilities or outsource testing to commercial laboratories. For the purpose of this analysis, FDA assumes that all large bottlers will use in-house testing facilities and that either 50 percent (low-cost assumption) or 100 percent (high-cost assumption) of small bottled water establishments will outsource their testing. According to the Small Business Administration's definition of small business for this industry, about 82 percent of bottled water establishments are defined as small (69 FR 70082 at 70088). This may overestimate the number of bottlers that will outsource testing and thus may overestimate the cost of the rule. FDA did not receive any significant comments on this section.
Table 2 of this document shows the breakdown of bottlers by the low-cost and high-cost testing models, based on laboratory choice and an 82-percent small business rate. For the 319 bottlers using other than a PWS source, either 188 bottlers (59 percent) will use in-house testing facilities and 131 bottlers (41 percent) will use commercial laboratories or 57 bottlers (18 percent) will use in-house testing facilities and 262 bottlers (82 percent) will use commercial laboratories. For the 95 bottlers using PWS sources, either 56 bottlers (59 percent) will use in-house testing facilities and 39 bottlers (41 percent) will use commercial laboratories or 17 bottlers (18 percent) will use in-house testing facilities and 78 bottlers (82 percent) will use commercial laboratories.
To estimate the number of samples that are likely to test positive for total coliform each year, FDA assumes that the frequency of total coliform positive samples is proportional to EPA's total coliform positive frequency estimates (Ref. 6). FDA did not receive any comments on this section.
EPA's total coliform positive frequency estimates are dependent on the probability of a total coliform positive, which is dependent on the annual number of samples tested, which varies by system size. FDA requirements include at least weekly testing for total coliform in source water and finished products, or at least 52 source water samples and 52 finished product samples per year. For example, bottlers whose source is other than a PWS will have to test their source water at least once a week and also their finished product at least once a week. Bottlers whose source is a PWS are only required to test their finished product. (For this model, FDA assumes that each bottler is testing one type of finished product.) EPA found that the frequency rate for total coliform positives in ground water PWSs testing between 31 and 82 samples for total coliform each year, ranged between 0.22 and 3 samples per year per system (Ref. 6). FDA assumes that the same frequency rates are applicable to bottled water plants testing 52 samples a year, thus the expected annual frequency rate of total coliform positive samples per bottled water source is at most 3 per year. FDA further assumes that the annual frequency of a total coliform positive for finished product testing is also at most three per bottler. For example, bottlers that are conducting total coliform tests for both their source and finished product can expect to find three total coliform positives from their source and three total coliform positives in their finished product or a total of six total coliform positive samples per year. This means that they will need to conduct six tests for
Source water that tests positive for
A bottler could not use source water from a source found to contain
This cost model assumes that bottlers will take action to rectify or eliminate the cause of contamination based on the first positive
As stated earlier, a source will be considered negative for
As noted previously, FDA requires bottlers to rectify or otherwise eliminate the cause of contamination of a source before source water can be used from that source. FDA drew on EPA's Economic Impact Analysis of the GWR to provide estimates for costs of rectifying or eliminating contamination.
Based on EPA's assumptions, FDA estimates one-time costs to bottlers of rectifying contamination range from approximately $17,000 to $22,000 each year.
Based on discussions with experts, EPA suggests that still other corrective actions such as fencing off or limiting access to protective wells could actually cost less than the two options listed previously from their model (Ref. 7).
In addition to the costs of a sanitary well or the costs of rehabilitating an existing well, other potential costs could include product loss, temporarily shutting down the operation, or changing to an alternate source. FDA did not receive any comments on this section.
Under this final rule, those bottlers that are required to test their source water and finished bottled water products at least weekly for total coliform (and for
Total costs for this final rule, including the estimated annual costs for
FDA estimates that 95 establishments that use PWSs are likely to find a total coliform positive three times a year in their finished product and thus will incur testing costs for
FDA estimates that 319 establishments that use sources other than PWSs are likely to find a total coliform positive about six times a year (three times in their source and three times in their finished product) and therefore, will incur testing costs for
Of the 319 establishments that obtain their water from other than a PWS, it is likely that 2.5 establishments will test positive for
Secondary testing costs are shown in table 10 of this document and illustrate costs for bottlers that will use either in-house or commercial laboratories.
Table 11 of this document shows the estimated total annual costs of this final rule (Option 3) by adding tables 7, 8, 9, and 10 to be $134,000 (low cost) and $189,000 (high cost). The estimated total discounted or present value costs (using a 7-percent interest rate over a 20-year period) are $1.4 million (low) and $1.9 million (high).
FDA is not aware of any outbreaks or enforcement actions associated with fecal pathogens in bottled water in the United States in the last 10 years. Therefore, we are not able to quantify any public health benefits of this option.
However, while FDA is not aware of any recent outbreaks associated with fecal pathogens in bottled water, this does not mean that such outbreaks could never occur. Under the current FDA regulations, the potential exists for fecal pathogens in ground water to be undetected and be distributed to consumers in bottled water and cause illness. Testing for the fecal indicator
By issuing this regulation, FDA will ensure that FDA's standards for the minimum quality of bottled water, as affected by fecal contamination, will be no less protective of the public health than those set by EPA for public drinking water.
FDA examined the economic implications of this final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601–612). If a rule has a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires us to analyze regulatory options that would lessen the economic effect of the rule on small entities. The Small Business Administration's definition of a small business for NAICS code 312112 Bottled Water Manufacturing is an entity with 500 or fewer employees. Under this definition, 82 percent of the bottled water firms (260 of 318) in the Dun's Market Identifiers database are identified as small firms (69 FR 70082 at 70088). Assuming that 82 percent of total annual costs shown in table 11 of this document will be incurred by small firms, and that 92 percent of the small firms are domestic, then total annual domestic costs of $100,000 to $140,000 will be incurred by the 260 small firms. However, because it is possible that a firm may not find a total coliform positive in any year during a 20-year period, subsequent testing for
To investigate the potential significance of these impacts, FDA entered these costs into a model created under contract by the Eastern Research Group (ERG) (Ref. 9). The model is designed to estimate the percentage of small firms that would go out of business because of compliance costs if those costs accrued to all small firms in a given industry. According to this model, an annual cost of $380 to $540 would generate a near zero percent probability that a small firm with less than 20 employees that faced those costs would go out of business. Because the costs per entity of this rule are small, the agency concludes that this final rule will not have a significant economic impact on a substantial number of small entities. FDA did not receive any comments on this section.
This final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). Comments on the information collection provisions of this final rule are being solicited in a separate notice published elsewhere in this issue of the
FDA has analyzed this rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive Order requires agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.”
Section 403A of the act (21 U.S.C. 343–1) is an express preemption provision. Section 403A(a) of the act provides that: “* * * no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce—(1) any requirement for a food which is the subject of a standard of identity established under section 401 that is not identical to such standard of identity or that is not identical to the requirement of section 403(g) * * *.” FDA has interpreted this provision to apply to standards of quality (21 CFR 100.1(c)(4)).
FDA has determined that the revisions to the standard of quality for bottled water relating to microbiological quality (§ 165.110(b)(2)) will have a preemptive effect on State law. Although this rule has a preemptive effect in that it will preclude States from issuing requirements for microbiological testing in bottled water that are not identical to the requirements for microbiological testing in bottled water as set forth in this rule, this preemptive effect is consistent with what Congress set forth in section 403A of the act. Section 403A(a)(1) of the act displaces both State legislative requirements and State common law duties (
The following references have been placed on display in the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified all Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the
1. Bacteriological Analytical Manual (BAM) Online. September 2002. Chapter 4: Enumeration of
2. International Bottled Water Association, 2007. Personal communication. August 30, 2007.
3. Skipton, Hay, Albrecht, “Drinking Water: Bottled or Tap?” University of Nebraska of Nebraska-Lincoln, Institute of Agriculture and Natural Resources, G1448, January 2002. Accessed online at
4. International Bottled Water Association, 2005, IBWA Model Code, Version March 2005. Accessed online at
5. Economic Analysis for the Final Groundwater Rule. Office of Water (4606–M) EPA 815–R–06–014 October 2006. Section 6.2.2 Laboratory Fees. Accessed online at:
6. Economic Analysis for the Final Groundwater Rule. Office of Water (4606–M) EPA 815–R–06–014 October 2006. Section 4.2.7 Triggered Monitoring Baseline. p. 4–21 and 4–22. Accessed online at
7. Economic Analysis for the Final Groundwater Rule. Office of Water (4606–M) EPA 815–R–06–014 October 2006. Section 6.4.4 Sanitary Survey Corrective Actions. p. 6–33. Accessed online at
8. Technology and Cost Document for the Final Ground Water Rule. Office of Water (4606–M) EPA 815–R–06–015 October 2006. Section 5.3.1 Significant Deficiency Corrective Actions. p. 5–11. Accessed online at
9. Eastern Research Group, Inc., “Model for Estimating the Impacts of Regulatory Costs on the Survival of Small Businesses and its Application to Four FDA-Regulated Industries,” Contract No. 223–01–2461, June 7, 2002.
Beverages, Bottled water, Food packaging, Reporting and recordkeeping requirements.
Beverages, Bottled water, Food grades and standards, Incorporation by reference.
21 U.S.C. 342, 348, 371, 374; 42 U.S.C. 264.
(a) * * *
(3) * * *
(i) Samples of source water from each source in use by the plant are to be taken and analyzed by the plant as often as necessary, but at a minimum frequency of once each year for chemical contaminants and once every 4 years for radiological contaminants. Additionally, source water obtained from other than a public water system is to be sampled and analyzed for total coliform at least once each week. If any coliform organisms are detected, follow-up testing must be conducted to determine whether any of the coliform organisms are
(4) * * *
(iv) The finished bottled water must comply with bottled water quality standards (§ 165.110(b) of this chapter) and section 402(a)(1) and (a)(3) of the
(g) * * *
(1) For bacteriological purposes, take and analyze at least once a week for total coliform a representative sample from a batch or segment of a continuous production run for each type of bottled drinking water produced during a day's production. The representative sample shall consist of primary containers of product or unit packages of product. If any coliform organisms are detected, follow-up testing must be conducted to determine whether any of the coliform organisms are
21 U.S.C. 321, 341, 343, 343–1, 348, 349, 371, 379e.
(b) * * *
(2)
(A)
(
(B)
(ii) Analyses conducted to determine compliance with paragraphs (b)(2)(i)(A) and (b)(2)(i)(B) of this section and § 129.35(a)(3)(i) of this chapter shall be made in accordance with the multiple-tube fermentation (MTF) or the membrane filter (MF) methods described in the applicable sections of “Standard Methods for the Examination of Water and Wastewater,” 21st Ed. (2005), American Public Health Association. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the American Public Health Association, 800 I St. NW., Washington, DC 20001, 202–777–2742 (APHA). You may inspect a copy at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–2163, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to:
(3)
(c)
(1) “Contains Excessive Bacteria” if the bottled water fails to meet the requirements of paragraph (b)(2)(i)(A) of this section.
(d)