Source: https://www.federalregister.gov/documents/2003/03/03/03-4972/beverages-bottled-water-companion-document-to-direct-final-rule
Timestamp: 2018-07-23 08:51:14
Document Index: 266437861

Matched Legal Cases: ['§\u2009165', '§\u2009165', '§\u2009165', 'art 129', 'art 129', '§\u2009129', '§\u2009129', '§\u2009129', '§\u2009165', '§\u2009165', '§\u2009165', 'art 165', 'art 51', 'art 51', 'art 51']

A Proposed Rule by the Food and Drug Administration on 03/03/2003
Submit written or electronic comments by May 2, 2003.
68 FR 9955
9955-9964 (10 pages)
03-4972
A. Initial Regulatory Impact Analysis
B. Initial Small Entity Analysis
https://www.federalregister.gov/d/03-4972 https://www.federalregister.gov/d/03-4972
The Food and Drug Administration (FDA) is proposing to amend its bottled water quality standard regulations by establishing an allowable level for the contaminant uranium. As a consequence, bottled water manufacturers would be required to monitor their finished bottled water products for uranium at least once each year under the current good manufacturing practice (CGMP) regulations for bottled water. Bottled water manufacturers would also be required to monitor their source water for uranium as often as necessary, but at least once every 4 years unless they meet the criteria for the source water monitoring exemptions under the CGMP regulations. FDA is not proposing any change in the existing allowable levels for combined radium-226/-228, gross alpha particle radioactivity, and beta particle and photon radioactivity. This proposed rule will ensure that the minimum quality of bottled water, as affected by uranium, combined radium-Start Printed Page 9956226/-228, gross alpha particle radioactivity, and beta particle and photon radioactivity, remains comparable with the quality of public drinking water that meets the Environmental Protection Agency's (EPA's) standards. This proposed rule is a companion to the direct final rule published elsewhere in this issue of the Federal Register.
This proposed rule is a companion to the direct final rule published in the final rules section of this issue of the Federal Register. The companion proposed rule and the direct final rule are substantively identical. This companion proposed rule will provide the procedural framework to finalize the rule in the event the direct final rule receives significant adverse comment and is withdrawn. The comment period for the companion proposed rule runs concurrently with the comment period of the direct final rule. Any comments received under the companion proposed rule will be treated as comments regarding the direct final rule. FDA is publishing the direct final rule because the rule contains noncontroversial changes, and the agency anticipates that it will receive no significant adverse comments. A detailed discussion of this rule is set forth in the preamble of the direct final rule. If no significant adverse comment is received in response to the direct final rule, no further action will be taken related to this proposed rule. Instead, FDA will publish a confirmation notice, after the comment period ends, to confirm the effective date of the direct final rule. The confirmation notice will publish no later than June 11, 2003. FDA intends the direct final rule to become effective December 8, 2003. If FDA receives significant adverse comment, the agency will withdraw the direct final rule. FDA will proceed to respond to all of the comments received regarding the rule, and, if appropriate, the rule will be finalized under this companion proposed rule using notice-and-comment procedures.
For additional information see the corresponding direct final rule published elsewhere in this issue of the Federal Register. All persons who wish to submit comments should review the detailed rationale for these amendments set out in the preamble discussion of the direct final rule.
If FDA receives any significant adverse comments regarding this rule, FDA will publish a document withdrawing the direct final rule and will proceed to respond to the comments under this companion proposed rule using usual notice-and-comment procedures.
A significant adverse comment is one that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or why it would be ineffective or unacceptable without a change. A comment recommending a rule change that is in addition to the rule will not be considered a significant adverse comment, unless the comment states why this rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to part of a rule and that part can be severed from the remainder of the rule, FDA may adopt as final those parts of the rule that are not the subject of a significant adverse comment.
The SDWA, as amended in 1996, requires EPA to publish an NPDWR that specifies either an MCL or a treatment technique requirement for contaminants that may “have an adverse effect on the health of persons,” are “known to occur or [have] a substantial likelihood [of occurring] in public water systems with a frequency and at levels of public Start Printed Page 9957health concern,” and for which “regulation * * * presents a meaningful opportunity for health risk reduction for persons served by public water systems” (SDWA section 1412(b)(1)(A)). The SDWA (section 300g-l(a)(3)) also requires that EPA issue MCLGs at the same time it issues NPDWRs. MCLGs are nonenforceable health goals that are based solely on considerations of protecting the public from the adverse health effects of contaminants, and not on other considerations, such as potential costs of regulating contaminants and potential technical difficulties of achieving the health goals (59 FR 38668 at 38671). EPA sets MCLs, the enforceable contaminant levels, as close as feasible to the nonenforceable MCLGs.
In its proposed rule on radionuclides (56 FR 33050), EPA proposed comprehensive changes to radionuclides standards in drinking water. However, after conducting a review of costs, benefits and treatment technologies, in the Radionuclides Rule, EPA established an MCL of 30 micrograms per liter (µg/L) for uranium and retained the existing MCLs of 5 picocuries per liter (pCi/L) for combined radium-226/-228, 15 pCi/L for gross alpha (excluding radon and uranium), and 4 millirem (mrem)/year for beta particle and photon radioactivity (65 FR 76708 at 76722).
With the exception of uranium, FDA's existing allowable levels for radionuclides (i.e., combined radium-226/-228, gross alpha particle radioactivity, and beta particle and photon radioactivity) in the bottled water quality standard are the same as EPA's existing MCLs for the same radionuclides in drinking water that EPA retained in the Radionuclides Rule. Therefore, FDA is not proposing any change to the existing allowable levels for these radionuclides in bottled water.
FDA has evaluated the MCL for uranium established by EPA for drinking water. FDA has tentatively concluded that EPA's MCL for uranium, as a standard of quality level for bottled water, is adequate for the protection of public health. Certain waters used for bottled water may be expected to contain uranium; thus, FDA believes that adopting EPA's MCL for uranium will ensure that the quality of bottled water is equivalent to the quality of public drinking water that meets EPA standards.
Therefore, FDA is proposing to establish in a new paragraph (b)(5)(i)(D) in § 165.110, an allowable level for uranium of 30 micrograms per liter of water.
In the Radionuclide Rule, EPA listed the analytical methods that it had approved for use by public water systems to determine compliance with the radionuclide MCLs (i.e. for uranium, combined radium-226/-228, gross alpha particle radioactivity, and beta particle and photon radioactivity) (65 FR 76708 at 76724). FDA is proposing to revise § 165.110(b)(5)(ii) by incorporating by reference EPA approved analytical methods (65 FR 76708 at 76725) for determining compliance with the quality standard for uranium activity in bottled water. FDA is also proposing to revise § 165.110(b)(5)(ii) by incorporating by reference EPA approved analytical methods for determining compliance with the Start Printed Page 9958quality standard for combined radium-226/-228, gross alpha particle radioactivity, and beta particle and photon radioactivity in bottled water (65 FR 76708 at 76725). FDA believes that these methods are sufficient to use for determining the level of uranium in bottled water.
FDA has established CGMP regulations for bottled water in part 129 (21 CFR part 129). Under § 129.35(a)(3)(i), source water must be analyzed by the plant as often as necessary, but at least once every 4 years for radiological contaminants. Therefore, once the rule becomes effective, bottlers would be required to test their source water as often as necessary but at least once every 4 years for uranium, combined radium-226/-228, gross alpha particle radioactivity, and beta particle and photon radioactivity, unless the bottlers meet the provisions in § 129.35(a)(4) for source water monitoring exemptions. Further, to ensure that a plant's production complies with applicable standards, § 129.80(g)(2) requires radiological analysis by the plant, at least annually, of a representative sample from a batch or segment of a continuous production run for each type of bottled water produced during a day's production. Therefore, once this rule becomes effective, bottlers would be required to test their finished bottled water products at least once a year for uranium, combined radium-226/-228, gross alpha particle radioactivity, and beta particle and photon radioactivity. In addition, bottled water must comply with the allowable levels for radionuclides in the quality standard for bottled water (§ 165.110(b)(5)(i)) unless the label bears a statement of substandard quality under § 165.110(c). As stated in § 165.110(d), bottled water is deemed adulterated if it contains a substance at a level considered injurious to health under section 402(a)(1) of the act.
FDA has examined the economic implications of this proposed rule as required by Executive Order 12866. 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). Executive Order 12866 classifies a rule as significant if it meets any one of a number of specified conditions, including: Having an annual effect on the economy of $100 million, adversely affecting a sector of the economy in a material way, adversely affecting competition, or adversely affecting jobs. A regulation is also considered a significant regulatory action if it raises novel legal or policy issues. FDA has determined that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.
Option 3. Bottled water producers are not subject to either an FDA quality standard regulation or an EPA NPDWR for uranium..
Note on Option 3: Since water used for bottled water comes from sources that likely contain some level of naturally occurring uranium, section 410(b)(1) of the act does not allow this option. The act specifies two alternatives: “promulgate a standard of quality regulation under this subsection,” or find that “such a regulation is not necessary to protect the public health because the contaminant is contained in water in public water systems * * * but not in water used for bottled drinking water.” However, the Office of Management and Budget (OMB) cost-benefit analysis guidelines recommend discussing statutory requirements that affect the selection of regulatory approaches. These guidelines also recommend analyzing the opportunity cost of legal constraints that prevent the selection of the regulatory action that best satisfies the philosophy and principles of Executive Order 12866. Our analysis finds that option 3 does not have the highest net benefits. Therefore, even if option 3 were permissible, the statute does not preclude the option with the highest net benefits.
Both the EPA NPDWR and the FDA standard of quality regulations will compel facilities to comply with the Start Printed Page 9959new uranium standard. Therefore, FDA assumes that options 1 or 2 will not differ in terms of the number of illnesses avoided or the burden placed on facilities compelled to adopt treatment technology. However, EPA and FDA do have differing monitoring requirements.
1,550 22. 14
Table 2 of this document summarizes these calculations. Considerable economies of scale exist in water treatment, but EPA only estimates the effect of economies of scale between their grouped size categories. Therefore, within the EPA size category we are assuming applies to bottled water, total treatment cost depends only on the amount of water treated, even though it is probable that larger facilities within this class have a lower per volume cost of treating their water. Also, for these options we base estimates of the amount of bottled water treated per facility not on our uncertain number of facilities but on a fixed total estimate of bottled water production in the United States. Therefore, except for rounding, our compliance cost estimate is not dependent on the number of facilities. We do expect that fewer facilities treating a larger amount of water would lead to lower per volume costs, but our most accurate estimate cannot take this into account, and this uncertainty does not affect the ranking of alternatives. We assume costs are incurred every year indefinitely into the future. The annual volume of bottled water consumed in the United States increased by an average of 7 percent over the past 11 years (Ref. 3), but again since the cost of treating water is subject to considerable economies of scale (Ref. 2) we assume that per year compliance costs will be roughly constant in the future. The discount rate used is 7 percent. We use the average of all four estimates of the middle value to construct the measure of central tendency, and the average of the two rounded lowest values and the two rounded highest values to construct the uncertainty interval. According to this analysis, total present value compliance costs will average approximately Start Printed Page 9960$1,085,000, with a range of $61,000-$2,660,000 for both options 1 and 2.
Exposure. According to the Bottled Water Reporter, Americans consumed a per capita average of approximately 73.8 liters of bottled water in 2001 (Ref. 3). This is approximately 18 percent of the per capita consumption of water from all sources estimated by the EPA (Ref 2). Bottled water consumption has been increasing at a rate of approximately 7 percent per year in the United States Start Printed Page 9961over the past 11 years, and this trend may continue (Ref 3).
Risk and Valuation of Risk. In September 1999, EPA updated a series of coefficients they developed to express the incremental lifetime risk of cancer morbidity or mortality per unit of intake. They then combined this per unit risk to the average and 90th percentile annual and lifetime intake of water from all sources (including bottled water, but they adjusted for bottled water that did not originate in the municipal water supplies they regulated) to calculate: (1) The total morbidity and mortality cancer risk due to drinking water containing uranium, and (2) the reduction in risk due to their proposed NPDWR for uranium. We adjust these values based on our calculation of the average annual intake of bottled water described previously in this document. The mortality risk coefficient per µg of uranium ingested is 3.97E-11, and the morbidity coefficient is 6.13E-11 (Ref. 4). In other words, for each µg of uranium ingested the lifetime risk of getting cancer increases by approximately 6 in 100 billion, while the lifetime risk of dying from cancer increases by approximately 4 in 100 billion.
These benefits calculations are subject to considerable uncertainty. The uncertainty interval used in the analysis is due to the uncertainty in the incidence and concentration of naturally occurring uranium and uncertainty in the uranium risk coefficients. However, the main uncertain benefits that we do not quantify are: (1) The reduction in kidney disease due to reducing uranium concentration in bottled water, and (2) the reduction in cocontaminants due to the adoption of treatment technologies for uranium. Therefore, the quantified cancer benefits probably underestimate the true positive impact of the uranium standard.
Table 5 of this document presents the total costs and benefits for all three options.
In the most likely central values in the distribution of cost and benefits, EPA option 1 has positive net measured benefits and FDA option 2 has positive net measured benefits. The ranking of option 1 and 2 depends completely on the frequency of required testing: FDA would require an average of 1.19 tests per year per facility, while EPA, after a series of four tests, would only require an average of .61 test per year per facility. We tested the effects of 5 percent-7 percent discount rates and 15-30 year delays in cancer onset in our Start Printed Page 9962benefits calculations, and both options still yield positive net benefits. The choice of the discount rate or time period before onset does not affect the relative ranking of options 1 and 2.
Under section 603(a) of the Regulatory Flexibility Act, for any proposed rule for which the agency is required by section 553 of the Administrative Procedure Act or any other law to publish a general notice of proposed rulemaking, the agency is required to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this companion proposed rule is a proposed rule for which a general notice of proposed rulemaking is required, and therefore, is subject to the Regulatory Flexibility Act, the agency will consider any comments it receives on the initial regulatory flexibility analysis in this companion proposed rule when deciding whether to withdraw the direct final rule.
FDA has examined the economic implications of this proposed 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 agencies to analyze regulatory options that would lessen the economic effect of the rule on small entities. FDA finds that this rule would have a significant economic impact on a substantial number of small entities.
According to the latest database search across the bottled water industry mentioned above, approximately 72 percent of firms qualify as small by the Small Business Administration (SBA) standard of having less than 500 full-time-equivalent employees. We assume that all SBA small firms operate a single facility for the purposes of this analysis. Since all facilities must adopt uranium testing, between 658 and 1,116 small firm facilities will incur a testing burden. Assuming the same distribution of size among out of compliance plants means that between 6 and 16 small facilities will incur the more costly burden of devoting resources to bring their water into compliance with the uranium standard issued in this rule. Table 6 of this document presents the average and maximum annual costs attributable to this rule for each small firm.
The Unfunded Mandates Reform Act of 1995 (Public Law 104-4), requiring cost-benefit and other analyses, in section 1531(a) defines a significant rule as “a Federal mandate that may result in the expenditure by State, local, and tribal governments in the aggregate, or by the private sector, of $100 million (adjusted annually for inflation) in any 1 year.” FDA has determined that this proposed rule does not constitute a significant rule under the Unfunded Mandates Reform Act.
FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule has a preemptive effect on State law. 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)(1) 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 Start Printed Page 9963standard 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)). Although this rule has preemptive effect in that it would preclude States from issuing requirements for uranium levels in bottled water that are not identical to the allowable level for uranium as set forth in this rule, this preemptive effect is consistent with what Congress set forth in section 403A of the act.
Further, section 4(e) of the Executive order provides that “when an agency proposed to act through adjudication or rulemaking to preempt State law, the agency shall provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings.” Given the statutory framework of section 410 of the act for bottled water, EPA's issuance of an MCL for uranium in public drinking water provided notice of possible FDA action for a standard of quality for uranium in bottled water. FDA did not receive any correspondence from State and local officials regarding a uranium standard for bottled water subsequent to EPA's NPDWR on the MCL for uranium. Moreover, FDA is not aware of any States that have requirements for uranium in bottled water that would be affected by FDA's decision to establish a bottled water quality standard for uranium that is consistent with EPA's standard for public drinking water. In addition, we are providing an opportunity for State and local officials to comment on FDA's standard of quality for uranium in bottled water in the context of this rulemaking. For the reasons set forth previously in this document, the agency believes that it has complied with all of the applicable requirements under the Executive order.
Interested persons may submit to the Dockets Management Branch (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments to http://www.fda.gov/​dockets/​ecomments or two hard copies of any written comments, except that individuals may submit one hard copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
The agency intends to make any final rule based on this proposal effective December 8, 2003. The agency will publish a confirmation notice for a final rule in the Federal Register no later than 180 days before the effective date. The agency is providing 180 days before the effective date to permit affected firms adequate time to take appropriate steps to bring their product into compliance with the standard imposed by the new rule.
1. Hamon, J., “Bottled Water Industry, 2001,” Special Industries Spotlight, January 2001. Available at http://www.merger.com.
2. Industrial Economics, Inc., Economic Analysis of the Radionuclides National Primary Drinking Water Regulations. Available from the Office of Ground Water and Drinking Water, U.S. Environmental Protection Agency, November, 2000.
3. Rodwan, John G., “The 2001 Stat: Bottled Water Sales Reach New Heights,” Bottled Water Reporter, p. 14-20, April/May 2002.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 165 be amended as follows:
(ii) Analyses conducted to determine compliance with the requirements of paragraph (b)(5)(i) of this section shall be made in accordance with the methods described in the applicable sections of “Standard Methods for the Examination of Water and Wastewater,” 20th Ed., which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of “Standard Methods for the Examination of Water and Wastewater,” 20th Ed., may be obtained from the American Public Health Association, 1015 15th St. NW., Washington, DC 20005. Copies of the methods incorporated by reference in this paragraph (b)(5)(ii) may also be examined at the Office of the Federal Register, 800 North Capital St. NW., suite 700, Washington, DC, or at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD.
Start Printed Page 9964
(1) Method 7500-U B—“Radiochemical Method,” which is contained in “Standard Methods for the Examination of Water and Wastewater,” 20th Ed., which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in the introductory text of paragraph (b)(5)(ii) of this section.
(2) Method 7500-U C—“Isotopic Method,” which is contained in “Standard Methods for the Examination of Water and Wastewater,” 20th Ed., which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. The availability of this incorporation by reference is given in the introductory text of paragraph (b)(5)(ii) of this section.
3. A statistical cancer case refers to expectations. For example, if the risk of contracting cancer sometime during one's life increases for each person by 1 in a million, and the affected population consisted of 1 million people, it is expected that the number of eventual cancer cases observed would increase by 1. However, 1 is only the measure of central tendency in a distribution of effects.
[FR Doc. 03-4972 Filed 2-27-03; 11:42 am]