97-4889. National Primary Drinking Water Regulations: Analytical Methods for Radionuclides  

  • [Federal Register Volume 62, Number 43 (Wednesday, March 5, 1997)]
    [Rules and Regulations]
    [Pages 10168-10174]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-4889]
    
    
    
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    _______________________________________________________________________
    
    Part V
    
    
    
    
    
    Environmental Protection Agency
    
    
    
    
    
    _______________________________________________________________________
    
    
    
    40 CFR Part 141
    
    
    
    National Primary Drinking Water Regulations: Analytical Methods for 
    Radionuclides; Final Rule and Proposed Rule
    
    Federal Register / Vol. 62, No. 43 / Wednesday, March 5, 1997 / Rules 
    and Regulations
    
    [[Page 10168]]
    
    
    
    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Part 141
    
    [WH-FRL-5689-9]
    RIN 2040-AC88
    
    
    National Primary Drinking Water Regulations: Analytical Methods 
    for Radionuclides
    
    AGENCY: Environmental Protection Agency.
    
    ACTION: Final rule.
    
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    SUMMARY: The Environmental Protection Agency (EPA) is approving the use 
    of 66 additional analytical methods for compliance with current 
    radionuclide drinking water standards and monitoring requirements. The 
    methods are applicable to gross alpha, gross beta, tritium, uranium, 
    radium-226, radium-228, gamma emitters, and radioactive cesium, iodine 
    and strontium. This rule is expected to satisfy public requests for 
    approval of new analytical technologies for measuring contaminants in 
    drinking water. This rule imposes no burden, because it does not 
    withdraw approval of any previously approved method. Today's final rule 
    follows the Proposed Notice of Rulemaking for Radionuclides in Drinking 
    Water published on July 18, 1991. The 1991 rulemaking proposed to 
    approve analytical methods and establish Maximum Contaminant Level 
    Goals (MCLGs) and National Primary Drinking Water Regulations (NPDWRs) 
    for several radionuclides. Today's final rule is limited to the 
    approval of additional analytical methods. In addition, since EPA 
    received comments suggesting approval of additional methods during the 
    comments period, EPA is proceeding with direct final rule making on 12 
    of the suggested methods. EPA is inviting comments on these 12 methods 
    elsewhere in today's rule.
    
    DATES: The effective date for amendment 2 is April 4, 1997. The 
    effective date for amendment 3 is May 5, 1997 unless EPA receives 
    adverse comments by April 4, 1997 requiring a response. If EPA receives 
    adverse comments, EPA will publish a timely withdrawal of amendment 3.
        The incorporation by reference of the publications listed in this 
    regulation is approved by the Director of the Federal Register as of 
    April 4, 1997.
        This regulation shall be considered final Agency action on May 9, 
    1997 at 1:00 p.m. Eastern Standard Time for purposes of judicial review 
    in accordance with 40 CFR 23.7.
    
    ADDRESSES: Adverse comments on the direct final rule must be submitted 
    to Chemistry Methods Docket Clerk, MC 4101, 401 M street, S.W., 
    Washington, D.C. 20460. Copies of the public comments received, EPA 
    responses, and all other supporting documents (including references 
    included in this notice) are available for review at the U.S. 
    Environmental Protection Agency, Water Docket, 401 M Street, S.W. 
    Washington, D.C. 20460. For access to the docket materials, call 202-
    260-3027 on Monday through Friday, excluding Federal holidays, between 
    9:00 a.m. and 3:30 p.m. Eastern Time for an appointment. Copies of 
    methods published by EPA are available for a nominal cost through the 
    National Technical Information Service (NTIS), U.S. Department of 
    Commerce, 5285 Port Royal Road, Springfield, VA 22161. NTIS also may be 
    reached at 800-553-6847. All other methods must be obtained from the 
    publisher. Sources (with addresses) for all approved methods are cited 
    at 40 CFR Part 141 and in the References section of today's rule.
    
    FOR FURTHER INFORMATION CONTACT:
        Dr. Richard Reding, Office of Ground Water and Drinking Water, U.S. 
    Environmental Protection Agency, 26 West Martin Luther King Drive, 
    Cincinnati, OH 45268, 513-569-7961; Dr. Jitendra Saxena, Office of 
    Ground Water and Drinking Water (4603), U.S. Environmental Protection 
    Agency, 401 M Street, S.W., Washington, D.C. 20460, 202-260-9579; or 
    one of the EPA Regional Office contacts listed below. General 
    information may also be obtained from the EPA Drinking Water Hotline. 
    Callers within the United States may reach the Safe Drinking Water 
    Hotline at 800-426-4791. The Safe Drinking Water Hotline is open Monday 
    through Friday, excluding Federal holidays, from 9:00 a.m. to 5:30 p.m. 
    Eastern Time.
        For technical information regarding the methods contact Stephen 
    Pia, National Exposure Research Laboratory, Office of Research and 
    Development, U.S. Environmental Protection Agency, P.O. Box 93478, Las 
    Vegas, NV 89193-3478, 702-798-2102.
        EPA Regional Offices:
    
    I  JFK Federal Bldg., One Congress Street, 11th floor, Boston, MA 
    02203, Phone: 617-565-3602, Jerry Healey
    II  290 Broadway, 24th Floor, New York, NY 10007, Phone: 212-637-3880, 
    Walter Andrews
    III  841 Chestnut Building, Philadelphia, PA 19107, Phone: 215-597-
    6511, Victoria Binetti
    IV  345 Courtland Street, N.E., Atlanta, GA 30365, Phone: 404-347-2207, 
    Wayne Aronson
    V  77 West Jackson Boulevard, Chicago, IL 60604, Phone: 312-886-6206, 
    Charlene Denys
    VI  1445 Ross Avenue, Suite 1200, Dallas, TX 75202, Phone: 214-655-
    7150, Oscar Cabra
    VII  726 Minnesota Avenue, Kansas City, KS 66101, Phone: 913-551-7682, 
    Robert Morby
    VIII  One Denver Place, 999 18th Street, Suite 500, Denver, CO 80202, 
    Phone: 303-293-1652, Patrick Crotty
    IX  75 Hawthorne Street, San Francisco, CA 94105, Phone: 415-744-1817, 
    Doris Betuel
    X  1200 Sixth Avenue, Seattle, WA 98101, Phone: 206-553-1893, Larry 
    Worley.
    
    SUPPLEMENTARY INFORMATION:
    
        Regulated entities: Entities potentially regulated by this action 
    are listed below:
    
    ------------------------------------------------------------------------
                     Category                  Example of regulated entities
    ------------------------------------------------------------------------
    Public Water Systems.....................  All public water systems that
                                                have at least 15 service    
                                                connections or regularly    
                                                serve an average of at least
                                                25 individuals daily at     
                                                least 60 days out of the    
                                                year.                       
    ------------------------------------------------------------------------
    
        This table is not intended to be exhaustive, but rather provides a 
    guide for readers regarding entities likely to be regulated by this 
    action. This table lists the type of entities that EPA is now aware 
    could potentially be regulated by this action. Other types of entities 
    not listed in the table could also be regulated. To determine whether 
    your business is regulated by this action, you should carefully examine 
    the applicability of the current radionuclide drinking water standards 
    and monitoring requirements in Sec. 141.15 and 141.16 of title 40 of 
    the Code of Federal Regulations. If you have questions regarding the 
    applicability of this action to a particular entity, consult the 
    persons listed in the preceding FOR FURTHER INFORMATION CONTACT 
    section.
    
    Table of Contents
    
    I. Statutory Authority
    II. Regulatory Background
    III. Explanation of Today's Action
    IV. Response to Comments Received on the Proposed Rule
    V. Regulation Assessment Requirements
    VI. References
    
    I. Statutory Authority
    
        The Safe Drinking Water Act (SDWA), as amended in 1996, requires 
    EPA to promulgate national primary drinking water regulations (NPDWRs) 
    which
    
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    specify maximum contaminant levels (MCLs) or treatment techniques for 
    drinking water contaminants (42 USC 300g-1). NPDWRs apply to public 
    water systems (42 USC 300f(1)(A)). According to section 1401(1)(D) of 
    the Act, NPDWRs include ``criteria and procedures to assure a supply of 
    drinking water which dependably complies with such maximum contaminant 
    levels; including quality control and testing procedures * * *.'' In 
    addition, Section 1445(a) of the Act authorizes the Administrator to 
    establish regulations for monitoring to assist in determining whether 
    persons are acting in compliance with the requirements of the SDWA. 
    EPA's promulgation of analytical methods is authorized under these 
    sections of the SDWA as well as the general rulemaking authority in 
    SDWA Section 1450(a) (42 USC 300j-9(a)).
    
    II. Regulatory Background
    
        EPA has promulgated analytical methods for all currently regulated 
    drinking water contaminants for which MCLs or monitoring requirements 
    have been promulgated. In most cases, the Agency has promulgated 
    regulations specifying (i.e., approving) use of more than one 
    analytical method for measurement of a contaminant, and laboratories 
    may use any approved method for determining compliance with an MCL or 
    monitoring requirement. After any regulation is published, EPA may 
    amend the regulations to approve additional methods, or modifications 
    to approved methods, or withdraw methods that become obsolete.
        On July 18, 1991 (56 FR 33050), EPA proposed to increase the number 
    of methods approved for radionuclide monitoring by proposing the use of 
    several new methods. EPA believed that these methods were as good as, 
    or better than, existing approved methods and procedures. EPA also 
    proposed drinking water standards (NPDWRs and MCLGs) and laboratory 
    certification criteria for several radionuclides, including radon. EPA 
    requested public comments on all of these proposed actions. Today's 
    notice takes final action only on the approval of methods for gamma 
    emitters, gross alpha, gross beta, radium-226, radium-228, uranium, 
    tritium and radioactive cesium, iodine, and strontium. For the reasons 
    discussed below, revision of standards for these radionuclides, and 
    standards and analytical methods for radon-222 may be addressed in a 
    separate rule.
        In 1995 EPA initiated a dialogue with stakeholders to prioritize 
    EPA drinking water activities in order to maximize health risk 
    reduction. That dialogue resulted in a draft report, published for 
    comment in November, 1995 (EPA 1995), proposing to reallocate EPA's 
    resources to those projects which have the highest risk reduction 
    potential. Assuring that analytical test methods for determining 
    compliance with existing standards remained ``up to date'' received 
    significant stakeholder support. Therefore, in today's rule, EPA is 
    approving some of the proposed radionuclide methods. EPA is not taking 
    action on any radon analytical methods or on any of the MCLGs or NPDWRs 
    that were proposed in the 1991 notice. Schedule for rulemaking on radon 
    and other radionuclides is governed by the 1996 SDWA Amendments.
    
    III. Explanation of Today's Action
    
        Today's action promulgates analytical methods for measurement of 
    radionuclides in drinking water based on the 1991 proposal (54 methods) 
    and on the public comments received on the 1991 proposal (12 methods). 
    This action also corrects method citation and typographical errors made 
    in the 1991 proposal. EPA is not withdrawing any of the 14 previously 
    approved methods in today's action, which means the EPA Methods, the 
    Standard Methods (13th edition) and ASTM methods that were previously 
    cited at 40 CFR 141.25(a) are still approved and included in amendments 
    2 and 3. Laboratories may continue to use these 14 methods or they may 
    choose from a group of 66 methods approved in today's rule. The 
    effective date for approval of the 54 methods based on the 1991 
    proposal is April 4, 1997. The effective date for approval of the 12 
    methods submitted as public comments is May 5, 1997 (see explanation 
    below).
        In the 1991 notice the Agency proposed 56 new methods for measuring 
    radionuclides in drinking water. The Agency is approving all but two of 
    these methods. The analytical methods proposed were considered to be 
    economically and technologically feasible for compliance monitoring. 
    EPA analyzed the most recent available information and considered 
    public comments on the proposal in arriving at the final selection of 
    methods in the table at 40 CFR 141.25(a). Method D-1943-81 was proposed 
    but is not approved today for gross alpha determinations because EPA 
    realized that the 500 pCi/L lower limit of the method is too high to be 
    of use for drinking water analysis. A precipitation method (Cs-01) for 
    cesium was also proposed but is not approved because the method is no 
    longer supported by its developer, the U.S. Department of Energy.
        Twelve of the methods approved in today's rule using direct final 
    rulemaking, are based on the public comments received on the 1991 
    proposal. Commenters submitted several methods or techniques for 
    consideration for approval. EPA evaluated and compared the sensitivity, 
    accuracy, precision and selectivity of the suggested methods to the 
    method performance requirements at 40 CFR 141.25 and to the data in 
    previously approved methods. EPA also determined whether the 
    performance data submitted by the commenter would insure compliance 
    with the radionuclide MCLs and monitoring requirements at 40 CFR 
    141.15, 141.16, 141.25 and 141.26. Based on this evaluation EPA is 
    approving twelve of these methods all of which are published, supported 
    and extensively peer reviewed by highly respected method organizations. 
    Of the twelve methods, six are published by the Standard Methods 
    Committee, two by the American Society for Testing and Materials 
    (ASTM), two by the U.S. Geological Survey (USGS) and two by the 
    Department of Energy (DOE). Eleven of these methods use technologies 
    that underlie methods that were proposed. Only one method uses a 
    technology that was not proposed in the 1991 rule. This new cost-saving 
    technology, pulsed laser phosphorimetry, was not proposed because no 
    validated method was available at the time of proposal. Approving these 
    additional methods will cause no burden because their use, like use of 
    all of the methods approved in this rule, is optional.
        The Agency is publishing the twelve methods suggested by public 
    comment on the 1991 proposed rule as a ``direct final'' rule. A direct 
    final rule is not an ``interim final'' rule (i.e. a rule which provides 
    for public comment after it has gone into effect); rather it is a rule 
    which is published with a delayed effective date allowing for the 
    receipt of and response to public comment before the rule goes into 
    effect. If EPA receives comments requiring response, then EPA will take 
    additional action necessary to respond to those comments prior to the 
    effective date (i.e. either withdraw the direct final rule or 
    promulgate today's companion proposal). This rule thus complies with 
    notice-and-comment requirements under the Administrative Procedure Act 
    (APA). EPA has chosen to use the direct final approach for these twelve 
    methods because the Agency does not expect to receive adverse public 
    comment and to allow for the most expeditious implementation
    
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    possible consistent with the APA. Elsewhere in today's Federal 
    Register, EPA is proposing these twelve methods. If EPA decides to 
    withdraw any or all of these methods based on public comment, EPA will 
    proceed with a revised rule based on this proposal. There will not be 
    an additional comment period, so parties interested in commenting on 
    the proposed rule should do so at this time.
        The methods approved based on public comments and their analytes 
    are: a co-precipitation method for gross alpha (7110C), two radon 
    emanation and two radiochemical methods for radium-226 (7500-Ra C, Ra-
    05, D 2460-90 and R-1140-76), an alpha spectrometry and a laser 
    phosphorimetry method for uranium (7500-U C and D 5174-91), one 
    radiochemical and one gamma spectrometry method for cesium (R-1111-76 
    and 7120), one radiochemical and one gamma spectrometry method for 
    iodine (7500-I C and 7500-I D) and a radiochemical method for strontium 
    (SR-02). EPA evaluated and selected these methods using the same 
    criteria (sensitivity, accuracy, precision and selectivity) that were 
    used to select methods for the 1991 proposal (56 FR 33092-33093). In 
    the proposal EPA stated that the ``reliability of these [proposed] 
    methods has been demonstrated by a history of many years' use by state, 
    federal and private laboratories''. Most of the methods approved in 
    today's rule have been collaboratively validated in multi laboratory 
    studies and the remainder in single laboratory studies.
        Today's rule also corrects method citations and typographical 
    errors made in the 1991 proposal. EPA has clarified the status of 
    method 7500-U C to reflect a change made by the publisher. In the 18th 
    edition of Standard Methods (1992), the fluorometric method 7500-U C 
    for determination of uranium was dropped and the method number, 7500-U 
    C, was assigned to an alpha spectrometry method for uranium. If the 
    Standard Methods version of the alpha spectrometry method had been 
    published earlier, EPA would have proposed it along with the four alpha 
    spectrometry and five fluorometric methods for uranium that were 
    proposed in the 1991 rule (56 FR 33124). As EPA is interested in 
    approving both fluorometric and alpha spectrometric methods for 
    uranium, this final rule approves method 7500-U C as a fluorometric 
    method in the 17th edition of Standard Methods and as an alpha 
    spectrometry method in the 18th and 19th editions of Standard Methods.
        The method numbers in the 1991 proposal for a radiochemical iodine 
    method and a liquid scintillation method were incorrect. These methods 
    are approved and correctly listed in today's rule as methods D 4785-93 
    and D 4107-91. Other errors, which include page number references in 
    the ``Interim Radiochemical Methodology for Drinking Water'' manual 
    (EPA 1976), method numbers in the ``EML Procedures Manual'' (DOE 1990) 
    and in the ``Radiochemical Procedures Manual'' (EPA 1987), and the 
    publication date of the U.S. Geological Survey (USGS) book, are also 
    corrected in today's rule.
    
    IV. Response to Comments Received on the Proposed Rule
    
        EPA received 160 analytical method related comments on the 1991 
    proposed rule. Commenters represented analytical laboratories, water 
    utilities, instrument manufacturers, State and local governments, and 
    trade associations. The majority of these comments dealt with radon 
    methods, laboratory certification criteria and questions about the 
    applicability of the methods to the proposed regulations. Only 27 
    comments were related to the methods covered by today's rule. Overall, 
    public comments strongly supported approval of new and innovative 
    methods for compliance with current radionuclide drinking water 
    standards and monitoring requirements. A summary of major comments and 
    the Agency's response to the issues raised are presented in this 
    section. The Agency's detailed response to these comments is available 
    in the public docket for this rule (EPA 1996).
        Several commenters submitted radiochemical analytical methods or 
    techniques to EPA for consideration for approval. EPA has approved 12 
    of the suggested methods because EPA believes they are as good as or 
    better than existing methods and procedures, and have been extensively 
    validated and peer reviewed. EPA has not approved 7 methods because 
    these methods were not accompanied with the supporting data that the 
    Agency believes is necessary for their evaluation.
        Commenters recommended approval of pulsed laser phosphorimetry for 
    analysis of uranium because it uses modern technology that is easier to 
    use than the currently approved fluorometric methods. EPA agrees with 
    this suggestion and as noted above, is approving laser phosphorimetry 
    method D-5174-91. This method was published by ASTM in 1992 and has 
    been validated to show that laser phosphorimetry is as good as or 
    better than previously approved techniques, such as fluorometry, for 
    the analysis of uranium in drinking water samples. EPA believes that 
    laboratories may adopt the laser phosphorimetry method because this 
    technology can increase hourly sample production to 15-20 samples as 
    compared to 2-5 samples using current fluorometric and alpha 
    spectrometric technologies.
        EPA was asked to withdraw approval of the fluorometric methods for 
    determination of uranium because the methods are old and somewhat 
    cumbersome compared to laser phosphorimetry. EPA disagrees that 
    fluorometric methods should be withdrawn. Although these methods were 
    approved about twenty years ago, they are not obsolete. These methods 
    provide acceptable results and they are still used by many 
    laboratories. It would be costly, burdensome and unnecessary to require 
    laboratories to adopt to another technique. The commenter did not 
    provide (and EPA does not have) data to show that these methods have 
    become unacceptable for compliance determinations of uranium.
        In the 1991 notice EPA proposed to replace americium-241 (Am-241) 
    with thorium-230 (Th-230) as the calibration standard in gross alpha 
    activity methods because Am-241 ``tended to bias analytic results'' (56 
    FR 33094). Commenters agreed with EPA's proposal but recommended that 
    EPA also allow use of natural uranium (Unat) as a calibration standard. 
    They stated that the alpha energies of both Unat and Th-230 better 
    approximate the alpha energies of uranium and radium-226, and both 
    isotopes also better approximate the attenuation of the alpha particles 
    caused by drinking water dissolved solids. EPA agrees with the comment 
    and a footnote in the table of approved methods at 40 CFR 141.25(a) now 
    approves use of either Unat or Th-230 as calibration standards for 
    gross alpha analyses with co-precipitation and evaporation methods. EPA 
    believes that Am-241 is only suitable for use with co-precipitation 
    methods. Therefore, future revisions of the evaporation methods may 
    specify use of only Unat and Th-230 as calibration standards. One 
    commenter asked where to obtain standards of Th-230 for use with the 
    gross alpha methods. Th-230 is readily available in a concentrated form 
    from commercial vendors.
        In the 1991 proposal EPA solicited comment on what conversion 
    factor to use with the approved methods that measure uranium in mass 
    units (micrograms) rather than in activity units (picocuries) (56 FR 
    33095). Uranium is measured in activity units
    
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    with radiochemical and alpha spectrometry methods and in mass units 
    with fluorometric and laser phosphorimetry methods. All of these 
    techniques are acceptable provided a conversion factor is used to 
    convert the fluorometric or laser phosphorimetric uranium result from 
    micrograms to picocuries. The factor is required because the uranium 
    contribution to the gross alpha activity MCL of 15 pCi/L must be 
    evaluated in picocuries not micrograms (40 CFR 141.15(b)).
        This conversion factor is not specified in the instructions in the 
    approved mass-type methods for uranium determinations. In the 1991 
    proposal EPA solicited comment on use of a conversion factor of 1.38 
    pCi/g or 0.67 pCi/g. No public comments were received 
    with respect to what factor to use to determine the activity 
    contribution of uranium to the current gross alpha activity 15 pCi/L 
    MCL. In today's rule the Agency is selecting the lower conversion 
    factor, 0.67 pCi/g, because it is a conservative factor that 
    is based on the 1:1 activity ratio of U-234 to U-238 characteristic of 
    naturally occurring uranium.
        Several commenters expressed confusion and wanted clarification 
    about the approval status of methods appearing in multiple editions of 
    the ASTM and Standard Methods publications. As ASTM annually reprints 
    all of the methods contained in the Annual Book of ASTM Methods, even 
    methods that have not been editorially or technically revised, EPA 
    permits the use of any edition of the ASTM book that contains the EPA-
    approved version of the compliance method. EPA is also approving at 
    this time versions of the radionuclide methods in Standard Methods for 
    the Examination of Water and Wastewater that are in the 13th, 17th, 
    18th and 19th editions of this publication. In the 1994 methods rule 
    which covered chemistry and microbiology methods (59 FR 62456), EPA 
    approved only one version of each compliance method that was published 
    in Standard Methods. EPA approved only one version because later 
    versions generally contained improvements in safety, quality assurance 
    or performance. EPA feels that changes in the recent versions of 
    radionuclide methods have not been significant enough to warrant 
    withdrawing the previous versions.
    
    V. Regulation Assessment Requirements
    
    A. Executive Order 12866
    
        Under Executive Order 12866 (58 FR 51735; October 4, 1993), the 
    Agency must determine whether the regulatory action is ``significant'' 
    and therefore subject to OMB review and the requirements of the 
    Executive Order. The Order defines ``significant regulatory action'' as 
    one that is likely to result in a rule that may:
        (1) Have an annual effect on the economy of $100 million or more, 
    or adversely affect in a material way the economy, a sector of the 
    economy, productivity, competition, jobs, the environment, public 
    health or safety, or State, local, or tribal governments or 
    communities;
        (2) Create a serious inconsistency or otherwise interfere with an 
    action taken or planned by another agency;
        (3) Materially alter the budgetary impact of entitlement, grants, 
    user fees, or loan programs or the rights and obligations of recipients 
    thereof; or
        (4) Raise novel legal or policy issues arising out of legal 
    mandates, the President's priorities, or the principles set forth in 
    the Executive Order.
        It has been determined that this rule is not a ``significant 
    regulatory action'' under the terms of Executive Order 12866 and is 
    therefore not subject to OMB review.
    
    B. Regulatory Flexibility Act
    
        Pursuant to section 605(b) of the Regulatory Flexibility Act, 5 
    U.S.C. 605(b), the Administrator certifies that this rule will not have 
    a significant economic impact on a substantial number of small 
    entities. This rule specifies additional analytical methods that 
    laboratories may choose to use in lieu of existing approved methods for 
    compliance measurement of radionuclides in drinking water. The rule 
    does not impose any new requirements on small entities. Monitoring 
    requirements were promulgated in earlier notices and are unaffected by 
    this rule. This rule merely increases operational flexibility under 
    these existing monitoring requirements. The rule may actually reduce 
    the cost of compliance monitoring for radionuclides by allowing 
    laboratories to use equipment and procedures that they may already own 
    or have developed. Therefore, the Agency believes that this notice 
    would have no adverse effect on any number of small entities.
    
    C. Unfunded Mandates Reform Act
    
        Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
    Law 104-4, establishes requirements for Federal agencies to assess the 
    effects of their regulatory actions on State, local, and tribal 
    governments and the private sector. Under section 202 of the UMRA, EPA 
    generally must prepare a written statement, including a cost-benefit 
    analysis, for proposed and final rules with ``Federal mandates'' that 
    may result in expenditures to State, local, and tribal governments, in 
    the aggregate, or to the private sector, of $100 million or more in any 
    one year. Before promulgating an EPA rule for which a written statement 
    is needed, section 205 of the UMRA generally requires EPA to identify 
    and consider a reasonable number of regulatory alternatives and adopt 
    the least costly, most cost-effective or least burdensome alternative 
    that achieves the objectives of the rule. The provisions of section 205 
    do not apply when they are inconsistent with applicable law. Moreover, 
    section 205 allows EPA to adopt an alternative other than the least 
    costly, most cost-effective or least burdensome alternative if the 
    Administrator publishes with the final rule an explanation why that 
    alternative was not adopted. Before EPA establishes any regulatory 
    requirements that may significantly or uniquely affect small 
    governments, including tribal governments, it must have developed under 
    section 203 of the UMRA a small government agency plan. The plan must 
    provide for notifying potentially affected small governments, enabling 
    officials of affected small governments to have meaningful and timely 
    input in the development of EPA regulatory proposals with significant 
    Federal intergovernmental mandates, and informing, educating, and 
    advising small governments on compliance with the regulatory 
    requirements.
        Today's rule contains no Federal mandates (under the regulatory 
    provisions of Title II of the UMRA) for State, local, or tribal 
    governments or the private sector. Today's rule approves use of 
    optional analytical methods and thus provides operational flexibility 
    to laboratories conducting analysis for radionuclides in drinking 
    water. The rule does not withdraw approval of any previously approved 
    methods. Thus, today's rule is not subject to the requirements of 
    sections 202 and 205 of the UMRA.
        EPA has determined that this rule contains no regulatory 
    requirements that might significantly or uniquely affect small 
    governments. The rule is highly technical and narrow in scope, and the 
    sole objective of the rule is to increase the number of methods 
    approved for measurement of radionuclides in drinking water. Thus, the 
    rule actually provides regulatory relief in the form of increased 
    operational flexibility for laboratory analysts.
    
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    D. Paperwork Reduction Act
    
        The rule contains no reporting or record keeping requirements and 
    consequently not subject to the Paperwork Reduction Act, 44 U.S.C. 3501 
    et seq.
    
    E. Science Advisory Board and National Drinking Water Advisory Council, 
    and Secretary of Health and Human Services
    
        In accordance with Section 1412(d) and (e) of the SDWA, the Agency 
    consulted with the Science Advisory Board, the National Drinking Water 
    Advisory Council, and the Secretary of Health and Human Services for 
    this action. They had no comments..
    
    F. Submission to Congress and the General Accounting Office
    
        Under 5 U.S.C. 801(a)(1)(A) as added by the Small Business 
    Regulatory Enforcement Fairness Act of 1996, EPA submitted a report 
    containing this rule and other required information to the U.S. Senate, 
    the U.S. House of Representatives and the Comptroller General of the 
    General Accounting Office prior to publication of the rule in today's 
    Federal Register. This rule is not a ``major rule'' as defined by 5 
    U.S.C. 804(2).
    
    VI. References
    
    APHA. Thirteenth, seventeenth, eighteenth and nineteenth editions of 
    Standard Methods for the Examination of Water and Wastewater, 1971, 
    1989, 1992, 1995, American Public Health Association, 1015 Fifteenth 
    Street N.W., Washington, D.C. 20005.
    ASTM. Annual Book of ASTM Methods, Vol. 11.02, 1994. American 
    Society for Testing and Materials, 100 Barr Harbor Drive, West 
    Conshohocken, PA 19428.
    DOE. ``EML Procedures Manual'', 27th Edition, Volume 1,1990. 
    Available at the Environmental Measurements Laboratory, U.S. 
    Department of Energy (DOE), 376 Hudson Street, New York, NY 10014-
    3621.
    EPA. 1976. ``Interim Radiochemical Methodology for Drinking Water'', 
    EPA 600/4-75-008 (revised), March 1976. Available at U.S. Department 
    of Commerce, National Technical Information Service (NTIS), 5285 
    Port Royal Road, Springfield, VA 22161 (Telephone 800-553-6847), PB 
    253258
    EPA. 1979. ``Radiochemical Analytical Procedures for Analysis of 
    Environmental Samples'', March 1979, NTIS EMSL LV 053917.
    EPA. 1980. ``Prescribed Procedures for Measurement of Radioactivity 
    in Water'', EPA 600/4-80-032, August 1980, NTIS PB 80-224744.
    EPA. 1987. ``Radiochemistry Procedures Manual'', EPA 520/5-84-006, 
    December 1987, NTIS PB 84-215581.
    EPA. 1995. Drinking Water Program Redirection Proposal, November 
    1995, pages 8-11, U.S. Environmental Protection Agency, Office of 
    Water Resource Center (RC-4100), 401 M. Street S.W., Washington, 
    D.C. 20460, EPA 810 D-95-001.
    EPA. 1996. ``Response to Comments on Radionuclide Methods on the 
    July 18, 1991 (56 FR 33050) Radionuclides Proposed Rule'', Office of 
    Water Docket (MC 4101), 401 M. St. S.W., Washington, D.C. 20460, 
    July 1996.
    NJ. ``Determination of Radium-228 in Drinking Water'', August 1990, 
    New Jersey Department of Environmental Protection, Division of 
    Environmental Quality, Bureau of Radiation and Inorganic Analytical 
    Services, 9 Ewing Street, Trenton, NJ 08625.
    NY. ``Determination of Ra-226 and Ra-228 (Ra-02)'', January 1980, 
    Revised June 1982, Radiological Institute Center for Laboratories 
    and Research, New York State Department of Health, Empire State 
    Plaza, Albany, NY 12201.
    USGS. ``Methods for Determination of Radioactive Substances in Water 
    and Fluvial Sediments'', Chapter A5 in Book 5 of Techniques of 
    Water-Resources Investigations of the United States Geological 
    Survey, 1977. Available at U.S. Geological Survey (USGS), 
    Information Services, Box 25286, Federal Center, Denver, CO 80225-
    0425.
    
    List of Subjects in 40 CFR Part 141
    
        Environmental protection, Analytical Methods, Incorporation by 
    reference, Intergovernmental relations, Monitoring, National Primary 
    Drinking water regulations, Radionoclides, Water supply.
    
        Dated: February 10, 1997
    Carol M. Browner,
    Administrator.
    
        For the reasons set out in the preamble, part 141 of title 40, Code 
    of Federal Regulations, are amended as follows:
    
    PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS
    
        1. The authority citation for part 141 continues to read as 
    follows:
    
        Authority: 42 U.S.C. 300f, 300g-1, 300g-2 300g-3, 300g-4, 300g-
    5, 300g-6, 300j-4, 300j-9.
    
        2. Section 141.25 is amended by revising paragraph (a) effective 
    April 4, 1997 to read as follows:
    
    
    Sec. 141.25  Analytical methods for radioactivity.
    
        (a) Analysis for the following contaminants shall be conducted to 
    determine compliance with Secs. 141.15 and 141.16 (radioactivity) in 
    accordance with the methods in the following Table, or their equivalent 
    as determined by EPA in accordance with Sec. 141.27.
    
    ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                               Reference (method or page number)                                                    
               Contaminant                Methodology     ------------------------------------------------------------------------------------------------------------------------------------------
                                                           EPA \1\       EPA \2\           EPA \3\           EPA \4\             SM \5\          ASTM \6\     USGS \7\     DOE \8\         Other    
    ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    Naturally occurring:                                                                                                                                                                            
      Gross alpha \11\ and beta.....  Evaporation........    900.0  p 1               00-01             p 1               302, 7110 B........  ...........   R-1120 -76  ...........  ..............
      Gross alpha \11\..............  Co-precipitation...  .......  ................  00-02             ................  ...................  ...........  ...........  ...........  ..............
      Radium 226....................  Radon emanation,       903.1  p 16              Ra-04             p 19              ...................   D 3454 -91    R-1141-76  ...........  N.Y.\9\       
                                       Radiochemical.        903.0  p 13              Ra-03                               304, 305, 7500-Ra B                                                       
      Radium 228....................  Radiochemical......    904.0  p 24              Ra-05             p 19              304, 7500-Ra D.....  ...........   R-1142 -76  ...........  N.Y.\9\       
                                                                                                                                                                                      N. J.\10\     
        Uranium \12\................  Radiochemical......    908.0  ................  ................  ................  7500-U B...........    D 2907-91    R-1180-76         U-04                
                                      Fluorometric.......    908.1                                                        7500-U C (17th Ed.)                 R-1181-76                             
                                                                                                                                                              R-1182-76          U-2                
    
    [[Page 10173]]
    
                                                                                                                                                                                                    
                                      Alpha spectrometry.  .......  ................  00-07             p 33              ...................    D 3972-90  ...........  ...........  ..............
    Man-made:                                                                                                                                                                                       
        Radioactive cesium..........  Radiochemical......    901.0  p 4               ................  ................  7500-Cs B..........    D 2459-72  ...........  ...........  ..............
                                      Gamma ray              901.1  ................  ................  p 92              ...................    D 3649-91   R-1110 -76      4.5.2.3                
                                       spectrometry.                                                                                                                                                
        Radioactive iodine..........  Radiochemical......    902.0  p 6               ................  ................  7500-I B...........  ...........  ...........  ...........  ..............
                                                                    p 9                                                                                                                             
                                      Gamma ray              901.1  ................  ................  p 92              7120 (19th Ed.)....    D 3649-91  ...........      4.5.2.3  ..............
                                       spectrometry.                                                                                             D 4785-88                                          
      Radioactive Strontium 89, 90..  Radiochemical......    905.0  p 29              Sr-04             p. 65             303, 7500-Sr B.....  ...........   R-1160 -76        Sr-01  ..............
      Tritium.......................  Liquid                 906.0  p 34              H-02              p. 87             306, 7500-3H B.....   D 4107 -91   R-1171 -76  ...........  ..............
                                       scintillation.                                                                                                                                               
      Gamma emitters................  Gamma ray..........    901.1  ................  ................  p 92              7120 (19th Ed.)....   D 3649 -91   R-1110 -76      4.5.2.3  ..............
                                      Spectrometry.......    902.0  ................  ................  ................  7500-Cs B..........   D 4785 -88  ...........  ...........  ..............
                                                             901.0                                                        7500-I B...........                                                       
    ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
     The procedures shall be done in accordance with the documents listed below. The incorporation by reference of documents 1 through 10 was approved by the Director of the Federal Register in   
      accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the documents may be obtained from the sources listed below. Information regarding obtaining these documents can be obtained from
      the Safe Drinking Water Hotline at 800-426-4791. Documents may be inspected at EPA's Drinking Water Docket, 401 M Street, SW., Washington, DC 20460 (Telephone: 202-260-3027); or at the      
      Office of the Federal Register, 800 North Capitol Street, NW., Suite 700, Washington, DC.                                                                                                     
    1. ``Prescribed Procedures for Measurement of Radioactivity in Drinking Water'', EPA 600/4-80-032, August 1980. Available at U.S. Department of Commerce, National Technical Information Service
      (NTIS), 5285 Port Royal Road, Springfield, VA 22161 (Telephone 800-553-6847), PB 80-224744.                                                                                                   
    2. ``Interim Radiochemical Methodology for Drinking Water'', EPA 600/4-75-008 (revised), March 1976. Available at NTIS, ibid. PB 253258.                                                        
    3. ``Radiochemistry Procedures Manual'', EPA 520/5-84-006, December 1987. Available at NTIS, ibid. PB 84-215581.                                                                                
    4. ``Radiochemical Analytical Procedures for Analysis of Environmental Samples'', March 1979. Available at NTIS, ibid. EMSL LV 053917.                                                          
    5. ``Standard Methods for the Examination of Water and Wastewater'', 13th, 17th, 18th, 19th Editions, 1971, 1989, 1992, 1995. Available at American Public Health Association, 1015 Fifteenth   
      Street N.W., Washington, D.C. 20005 . All methods are in the 17th, 18th and 19th editions except 7500-U C Fluorometric Uranium was discontinued after the 17th Edition, and 302, 303, 304, 305
      and 306 are only in the 13th Edition.                                                                                                                                                         
    6. Annual Book of ASTM Standards, Vol. 11.02, 1994. Available at American Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken, PA 19428.                                
    7. ``Methods for Determination of Radioactive Substances in Water and Fluvial Sediments'', Chapter A5 in Book 5 of Techniques of Water-Resources Investigations of the United States Geological 
      Survey, 1977. Available at U.S. Geological Survey (USGS) Information Services, Box 25286, Federal Center, Denver, CO 80225-0425.                                                              
    8. ``EML Procedures Manual'', 27th Edition, Volume 1, 1990. Available at the Environmental Measurements Laboratory, U.S. Department of Energy (DOE), 376 Hudson Street, New York, NY 10014-3621.
    9. ``Determination of Ra-226 and Ra-228 (Ra-02)'', January 1980, Revised June 1982. Available at Radiological Sciences Institute Center for Laboratories and Research, New York State Department
      of Health, Empire State Plaza, Albany, NY 12201.                                                                                                                                              
    10. ``Determination of Radium 228 in Drinking Water'', August 1980. Available at State of New Jersey, Department of Environmental Protection, Division of Environmental Quality, Bureau of      
      Radiation and Inorganic Analytical Services, 9 Ewing Street, Trenton, NJ 08625.                                                                                                               
    11. Natural uranium and thorium-230 are approved as gross alpha calibration standards for gross alpha with co-precipitation and evaporation methods; americium-241 is approved with co-         
      precipitation methods.                                                                                                                                                                        
    12. If uranium (U) is determined by mass, a 0.67 pCi/g of uranium conversion factor must be used. This conservative factor is based on the 1:1 activity ratio of U-234 to U-238 that is
      characteristic of naturally occurring uranium.                                                                                                                                                
    
        3. Section 141.25 is amended by revising paragraph (a) effective 
    May 5, 1997 to read as follows:
    
    
    Sec. 141.25  Analytical Methods for Radioactivity.
    
        (a) Analysis for the following contaminants shall be conducted to 
    determine compliance with Secs. 141.15 and 141.16 (radioactivity) in 
    accordance with the methods in the following Table, or their equivalent 
    determined by EPA in accordance with Sec. 141.27.
    
    ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                               Reference (method or page number)                                                    
               Contaminant                Methodology     ------------------------------------------------------------------------------------------------------------------------------------------
                                                           EPA\1\      EPA\2\         EPA\3\         EPA\4\            SM\5\             ASTM\6\           USGS\7\          DOE\8\         Other    
    ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    Naturally occurring:                                                                                                                                                                            
      Gross alpha \11\ and beta.....  Evaporation........   900.0  p 1            00-01          p 1            302, 7110 B.......  ................  R-1120-76         .............  .............
      Gross alpha \11\..............  Co-precipitation...  ......  .............  00-02          .............  7110 C............  ................  ................  .............               
    
    [[Page 10174]]
    
                                                                                                                                                                                                    
        Radium 226..................  Radon emanation,...   903.1  p 16           Ra-04          p 19           7500-Ra C.........  D 3454-91         R-1141-76         Ra-05          N.Y.\9\      
                                      Radio chemical.....   903.0  p 13           Ra-03                         304, 305,.........  D 2460-90         R-1140-76                                     
                                                                                                                7500-Ra B.........                                                                  
        Radium 228..................  Radio chemical.....   904.0  p 24           Ra-05          p 19           304, 7500-Ra D....  ................  R-1142-76         .............  N.Y.\9\      
                                                                                                                                                                                       N.J.\10\     
        Uranium\12\.................  Radio chemical.....   908.0  .............  .............  .............  7500-U B..........  ................  ................  .............  .............
                                      Fluorometric.......   908.1  .............  .............  .............  7500-U C (17th       D2907-91         R-1180-76         U-04           .............
                                                                                                                 Ed.).                                R-1181-76                                     
                                      Alpha spectro metry  ......  .............  00-07          p33            7500-U C (18th or   D 3972-90         R-1182-76         U-02           .............
                                                                                                                 19th Ed.).                                                                         
                                      Laser Phospho        ......  .............  .............  .............  ..................  D 5174-91         ................  .............  .............
                                       rimetry.                                                                                                                                                     
    Man-made:                                                                                                                                                                                       
        Radioactive cesium..........  Radio chemical.....   901.0  p 4            .............  .............  7500-Cs B.........  D 2459-72         R-1111-76         .............  .............
                                      Gamma ray             901.1  .............  .............  p 92           7120 (19th Ed.)...  D 3649-91         R-1110-76         4.5.2.3        .............
                                       spectrometry.                                                                                                                                                
        Radioactive iodine..........  Radio chemical.....   902.0  p 6            .............  .............  7500-I B..........   D3649-91         ................  4.5.2.3        .............
                                                                   p 9                                          7500-I C..........                                                                  
                                                                                                                7500-I D..........                                                                  
                                      Gamma ray             901.1  .............  .............  p 92           7120 (19th Ed.)...  D 4785-88         ................  4.5.2.3                     
                                       spectrometry.                                                                                                                                                
        Radioactive Strontium 89, 90  Radio chemical.....   905.0  p 29           Sr-04          p. 65          303, 7500-Sr B....  ................  R-1160-76         Sr-01          .............
                                                                                                                                                                        Sr-02                       
        Tritium.....................  Liquid                906.0  p 34           H-02           p. 87          306, 7500-3H B....  D 4107-91         R-1171-76         .............  .............
                                       scintillation.                                                                                                                                               
      Gamma emitters................  Gamma ray..........   901.1  .............  .............  p92            7120 (19th Ed.)...  D 3649-91         R-1110-76         4.5.2.3        .............
                                      Spectrometry.......   902.0  .............  .............  .............  7500-Cs B.........  D 4785-88         ................  .............  .............
                                        .................   901.0  .............  .............  .............  7500-I B..........  ................  ................  .............  .............
    ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    The procedures shall be done in accordance with the documents listed below. The incorporation by reference of documents 1 through 10 was approved by the Director of the Federal Register in    
      accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the documents may be obtained from the sources listed below. Information regarding obtaining these documents can be obtained from
      the Safe Drinking Water Hotline at 800-426-4791. Documents may be inspected at EPA's Drinking Water Docket, 401 M Street, SW., Washington, DC 20460 (Telephone: 202-260-3027); or at the      
      Office of Federal Register, 800 North Capitol Street, NW., Suite 700, Washington, DC.                                                                                                         
    \1\ ``Prescribed Procedures for Measurement of Radioactivity in Drinking Water'', EPA 600/4-80-032 , August 1980. Available at U.S. Department of Commerce, National Technical Information      
      Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161 (Telephone 800-553-6847), PB 80-224744.                                                                                           
    \2\ ``Interim Radiochemical Methodology for Drinking Water'', EPA 600/4-75-008(revised), March 1976. Available at NTIS, ibid. PB 253258.                                                        
    \3\ ``Radiochemistry Procedures Manual'', EPA 520/5-84-006, December 1987. Available at NTIS, ibid. PB 84-215581.                                                                               
    \4\ ``Radiochemical Analytical Procedures for Analysis of Environmental Samples'', March 1979. Available at NTIS, ibid. EMSL LV 053917.                                                         
    \5\ ``Standard Methods for the Examination of Water and Wastewater'', 13th, 17th, 18th, 19th Editions, 1971, 1989, 1992, 1995. Available at American Public Health Association, 1015 Fifteenth  
      Street N.W., Washington, D.C. 20005. All methods are in the 17th, 18th and 19th editions except 7500-U C Fluorometric Uranium was discontinued after the 17th Edition, 7120 Gamma Emitters is 
      only in the 19th Edition, and 302, 303, 304, 305 and 306 are only in the 13th Edition.                                                                                                        
    \6\ Annual Book of ASTM Standards, Vol. 11.02, 1994. Available at American Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken, PA 19428.                               
    \7\ ``Methods for Determination of Radioactive Substances in Water and Fluvial Sediments'', Chapter A5 in Book 5 of Techniques of Water-Resources Investigations of the United States Geological
      Survey, 1977. Available at U.S. Geological Survey (USGS) Information Services, Box 25286, Federal Center, Denver, CO 80225-0425.                                                              
    \8\ ``EML Procedures Manual'', 27th Edition, Volume 1, 1990. Available at the Environmental Measurements Laboratory, U.S. Department of Energy (DOE), 376 Hudson Street, New York, NY 10014-    
      3621.                                                                                                                                                                                         
    \9\ ``Determination of Ra-226 and Ra-228 (Ra-02)'', January 1980, Revised June 1982. Available at Radiological Sciences Institute Center for Laboratories and Research, New York State          
      Department of Health, Empire State Plaza, Albany, NY 12201.                                                                                                                                   
    \10\ ``Determination of Radium 228 in Drinking Water'', August 1980. Available at State of New Jersey, Department of Environmental Protection, Division of Environmental Quality, Bureau of     
      Radiation and Inorganic Analytical Services, 9 Ewing Street, Trenton, NJ 08625.                                                                                                               
    \11\ Natural uranium and thorium-230 are approved as gross alpha calibration standards for gross alpha with co-precipitation and evaporation methods; americium-241 is approved with co-        
      precipitation methods.                                                                                                                                                                        
    \12\ If uranium (U) is determined by mass, a 0.67 pCi/g of uranium conversion factor must be used. This conservative factor is based on the 1:1 activity ratio of U-234 to U-238 that is        
      characteristic of naturally occurring uranium.                                                                                                                                                
    
    * * * * *
    [FR Doc. 97-4889 Filed 3-4-97; 8:45 am]
    BILLING CODE 6560-50-P
    
    
    

Document Information

Effective Date:
4/4/1997
Published:
03/05/1997
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
97-4889
Dates:
The effective date for amendment 2 is April 4, 1997. The effective date for amendment 3 is May 5, 1997 unless EPA receives adverse comments by April 4, 1997 requiring a response. If EPA receives adverse comments, EPA will publish a timely withdrawal of amendment 3.
Pages:
10168-10174 (7 pages)
Docket Numbers:
WH-FRL-5689-9
RINs:
2040-AC88: Analytic Methods for Measuring Radionuclides in the Drinking Water Program
RIN Links:
https://www.federalregister.gov/regulations/2040-AC88/analytic-methods-for-measuring-radionuclides-in-the-drinking-water-program
PDF File:
97-4889.pdf
CFR: (1)
40 CFR 141.25