[Federal Register Volume 65, Number 42 (Thursday, March 2, 2000)] [Rules and Regulations] [Pages 11373-11385] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 00-4761] [[Page 11371]] ----------------------------------------------------------------------- Part II Environmental Protection Agency ----------------------------------------------------------------------- 40 CFR Part 141 Unregulated Contaminant Monitoring Regulation for Public Water Systems: Analytical Methods for Perchlorate and Acetochlor; Announcement of Laboratory Approval and Performance Testing (PT) Program for the Analysis of Perchlorate; Final Rule and Proposed Rul [[Page 11372]] e Federal Register/Vol. 42 , No. 65 /Thursday, March 2, 2000/Rules and Regulations ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 141 [FRL-6544-6 ] Unregulated Contaminant Monitoring Regulation for Public Water Systems; Analytical Methods for Perchlorate and Acetochlor; Announcement of Laboratory Approval and Performance Testing (PT) Program for the Analysis of Perchlorate AGENCY: Environmental Protection Agency. ACTION: Direct final rule. ----------------------------------------------------------------------- SUMMARY: The Safe Drinking Water Act (SDWA), as amended in 1996, requires the U.S. Environmental Protection Agency to establish criteria for a program to monitor unregulated contaminants and to publish a list of contaminants to be monitored. In fulfillment of this requirement, EPA published the Revisions to the Unregulated Contaminant Monitoring Rule (UCMR) on September 17, 1999 (64 FR 50556), which included a list of contaminants to be monitored. Both perchlorate and acetochlor were placed on the UCMR (1999) List 1, Assessment Monitoring, with the method listed as ``Reserved'' pending imminent conclusion of EPA refinement and review of the analytical methods for perchlorate and acetochlor. EPA is taking direct final action on this rule. This rule specifies the approved analytical methods for measurement of perchlorate and acetochlor in drinking water and includes notice to all laboratories interested in supporting perchlorate monitoring of the laboratory approval requirements, including participation in a perchlorate Performance Testing (PT) Program. The rule also includes minor technical changes to correct or clarify the rule published on September 17, 1999. DATES: This rule is effective on January 1, 2001, without further notice, unless EPA receives adverse comment by April 3, 2000. If EPA receives such comment we will publish a timely withdrawal in the Federal Register and inform the public that the rule will not take effect. The incorporation by reference of the publications listed in today's rule is approved by the Director of the Federal Register as of January 1, 2001. For judicial review purposes, this final rule is promulgated as of 1:00 p.m. (Eastern time) on March 16, 2000, as provided in 40 CFR 23.7. Any laboratory interested in conducting perchlorate monitoring must participate in the Performance Testing (PT) Program and should submit a request letter to EPA, received at the EPA by March 31, 2000. EPA will not be able to consider any letters received after this date. Any interested laboratory which does not meet this deadline or fails to successfully pass the initial PT study and would still like to support this monitoring, will need to submit a request letter by October 6, 2000 in order to be eligible for a second PT study. ADDRESSES: Send written comments to the Comment Clerk, docket number W- 99-19, Water Docket (MC 4101), U.S. EPA, 401 M Street, SW, Washington DC, 20460. Please submit an original and three copies of your comments and enclosures (including references). The full record for this document has been established under docket number W-99-19 and includes supporting documentation as well as printed, paper versions of electronic comments. The full record is available for inspection from 9 a.m. to 4 p.m., Monday through Friday, excluding legal holidays, at the Water Docket, East Tower Basement, U.S. EPA, 401 M Street, SW, Washington DC. For access to docket (Docket No. W-99-19) materials, please call (202) 260-3027 between 9 a.m. and 3:30 p.m., Eastern Time, Monday through Friday, to schedule an appointment. A reasonable fee may be charged for copying. Laboratories interested in supporting perchlorate monitoring must send a request letter to: Daniel P. Hautman, Perchlorate PT Program Coordinator, MLK 140, U.S. EPA, 26 W. Martin Luther King Dr., Cincinnati, OH 45268. FOR FURTHER INFORMATION CONTACT: Rachel Sakata, Standards and Risk Management Division, U.S. Environmental Protection Agency, 401 M Street (MC 4607), Washington DC 20460, (202) 260-2527. For technical information regarding the methods, contact David Munch, Technical Support Center, U.S. Environmental Protection Agency, 26 W. Martin Luther King Dr., Cincinnati OH, 45268, (513) 569-7843. General information may also be obtained from the EPA Safe Drinking Water Hotline. Callers within the United States may reach the Hotline at (800) 426-4791. The Hotline is open Monday through Friday, excluding federal holidays, from 9:00 a.m. to 5:30 p.m. Eastern Time. SUPPLEMENTARY INFORMATION: For copies of EPA Method 314.0, ``Determination of Perchlorate in Drinking Water Using Ion Chromatography,'' contact the EPA Safe Drinking Water Hotline within the United States at (800) 426-4791 (Hours are Monday through Friday, excluding federal holidays, from 9:00 a.m. to 5:30 p.m. Eastern Time). Alternately, the method can be assessed and downloaded directly on-line at www.epa.gov/safewater/methods/sourcalt.html. Abbreviations and Acronyms Used in the Preamble and Final Rule ------------------------------------------------------------------------ ------------------------------------------------------------------------ 2,4-DNT................................... 2,4-dinitrotoluene. 2,6-DNT................................... 2,6-dinitrotoluene. 4,4'-DDE.................................. 4,4'-dichloro dichlorophenyl ethylene, a degradation product of DDT. Alachlor ESA.............................. alachlor ethanesulfonic acid, a degradation product of alachlor. AOAC...................................... Association of Official Analytical Chemists. ASTM...................................... American Society for Testing and Materials. CAS....................................... Chemical Abstract Service. CASRN..................................... Chemical Abstract Service Registry Number. CCL....................................... Contaminant Candidate List. CFR....................................... Code of Federal Regulations. CWS....................................... community water system. DCPA...................................... dimethyl tetrachloroterephthalate, chemical name of the herbicide dacthal. DCPA mono- and di-acid degradates......... degradation products of DCPA. EPA....................................... Environmental Protection Agency. EPTC...................................... s-ethyl- dipropylthiocarbamate, an herbicide. EPTDS..................................... Entry Point to the Distribution System. ESA....................................... ethanesulfonic acid, a degradation product of alachlor. FSIS...................................... federalism summary impact statement. IC........................................ ion chromatography. ICR....................................... Information Collection Rule. MCL....................................... maximum contaminant level. MCT....................................... Matrix Conductivity Threshold. MDL....................................... method detection limit. MRL....................................... minimum reporting level. MS........................................ sample matrix spike. MSD....................................... sample matrix spike duplicate. NCOD...................................... National Drinking Water Contaminant Occurrence Database. NTNCWS.................................... non-transient non-community water system. NTTAA..................................... National Technology Transfer and Advancement Act. OGWDW..................................... Office of Ground Water and Drinking Water. [[Page 11373]] OMB....................................... Office of Management and Budget. PBMS...................................... Performance-based Measurement System. PWS....................................... Public Water System. QA........................................ quality assurance. QC........................................ quality control. RFA....................................... Regulatory Flexibility Act. SBREFA.................................... Small Business Regulatory Enforcement Fairness Act. SDWA...................................... Safe Drinking Water Act. SM........................................ Standard Methods. SOP....................................... standard operating procedure. TDS....................................... total dissolved solid. UCMR...................................... Unregulated Contaminant Monitoring Regulation/Rule. UCM....................................... Unregulated Contaminant Monitoring. UMRA...................................... Unfunded Mandates Reform Act of 1995. USEPA..................................... United States Environmental Protection Agency. VOC....................................... volatile organic compound. ug/L...................................... micrograms per liter. uS/cm..................................... microsiemens per centimeter. ------------------------------------------------------------------------ Preamble Outline I. Regulatory Background II. Explanation of Today's Action A. Relation to the UCMR Published in September 1999 B. Systems Affected by This Rule C. Analytical Methods 1. Perchlorate 2. Acetochlor 3. Quality Control and Analytical Confirmation D. Peer Review 1. Perchlorate 2. Acetochlor E. Laboratory Approval and Certification 1. Perchlorate 2. Acetochlor F. Implementation G. Performance-based Measurement System III. Technical Changes and Clarification to Sec. 141.40 A. Change to Sec. 141.40 (a)(5)(ii)(C) B. Change to Sec. 141.40 (a)(5)(ii)(G) C. Change to Sec. 141.40 (a)(5)(iii)(G) D. Change to Sec. 141.40 (b)(1)(i) E. Change to Sec. 141.40 (b)(1)(vii) F. Clarification of Monitoring for DCPA Mono and Di-Acid Degradate IV. Cost and Benefits of the Rule V. Administrative Requirements A. Executive Order 12866--Regulatory Planning and Review B. Executive Order 13045--Protection of Children From Environmental Health Risks and Safety Risks C. Unfunded Mandates Reform Act D. Paperwork Reduction Act E. Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et.seq. F. National Technology Transfer and Advancement Act G. Executive Order 12898--Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations H. Executive Order 13132--Federalism I. Executive Order 13084--Consultation and Coordination with Indian Tribal Governments J. Administrative Procedure Act K. Congressional Review Act VI. Public Involvement in Regulation Development Potentially Regulated Entities The regulated entities are public water systems. All large community and non-transient non-community water systems serving more than 10,000 persons are required to monitor under the revised UCMR. A community water system (CWS) is a public water system which serves at least 15 service connections used by year-round residents or regularly serve at least 25 year-round residents. Non-transient non-community water system (NTNCWS) means a public water system that is not a community water system and that regularly serves at least 25 of the same persons over 6 months per year. Only a national representative sample of community and non-transient non-community systems serving 10,000 or fewer persons are required to monitor for perchlorate and acetochlor. Transient non-community systems, which are systems that do not regularly serve at least 25 of the same persons over six months per year, are not required to monitor. States, Territories, and Tribes, with primacy to administer the regulatory program for public water systems under the Safe Drinking Water Act sometimes conduct analyses to measure for contaminants in water samples and are regulated by this action. Categories and entities potentially regulated by this action include the following: -------------------------------------------------------------------------------------------------------------------------------------------------------- Category Examples of potentially regulated entities SIC -------------------------------------------------------------------------------------------------------------------------------------------------------- State, Territorial, and Tribal governments........................... States, territorial and tribal governments that analyze water 9511 samples on behalf of public water systems required to conduct such analysis; States, Territorial and tribal governments that themselves operate community and non-transient non-community water systems required to monitor. Industry............................................................. Private operators of community and non-transient non-community water 4941 systems required to monitor. Municipalities....................................................... Municipal operators of community and non-transient non-community 9511 water systems required to monitor. -------------------------------------------------------------------------------------------------------------------------------------------------------- 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 types of entities that EPA is now aware of that could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. To determine whether your facility is regulated by this action, you should carefully examine the applicability criteria in Sec. 141.40 of the revised Unregulated Contaminant Monitoring Rule, published September 17, 1999 in 64 FR 50556. If you have questions regarding the applicability of this action to a particular entity, consult the first person listed in the preceding FOR FURTHER INFORMATION CONTACT section. I. Regulatory Background SDWA section 1445 (a)(2), as amended in 1996, requires EPA to establish criteria for a program to monitor unregulated contaminants and to publish a list of contaminants to be monitored. To meet these requirements, EPA published the Revisions to the Unregulated Contaminant Monitoring Regulation (UCMR) for Public Water Systems on September 17, 1999, (64 FR 50556) which substantially revised the previous Unregulated Contaminant Monitoring (UCM) Program, codified at 40 CFR 141.40. The UCMR revised the regulations at 40 CFR 141.35, 141.40, 142.16 and deleted and reserved 142.15(c)(3). The UCMR covered: (1) The frequency and schedule for monitoring, based on PWS size, water source, and likelihood of finding contaminants; (2) a new, shorter list of contaminants for which systems will monitor, referred to as the UCMR (1999) List; (3) procedures for selecting and monitoring a nationally representative sample of small PWSs (those serving [[Page 11374]] 10,000 or fewer persons), and; (4) procedures for entering the monitoring data in the National Drinking Water Contaminant Occurrence Database (NCOD), as required under section 1445. This final rule included a list of contaminants which must be monitored beginning January 2001 to obtain data on contaminants occurring or likely to occur in the drinking water of public water systems. Perchlorate and acetochlor were included on the UCMR (1999) List 1, with their analytical methods listed as ``reserved'', pending the imminent conclusion of EPA refinement and review of the analytical methods and implementation of a laboratory approval for perchlorate and validation studies for acetochlor. Today's rule amends the 1999 UCMR to specify methods for monitoring of perchlorate and acetochlor. Today's rule also contains several technical corrections to the September 1999 rule. II. Explanation of Today's Action Today's action promulgates analytical methods for measurement of perchlorate and acetochlor in drinking water, contaminants which were placed on the UCMR (1999) List 1. A. Relation to the UCMR Published in September 1999 The final UCMR, published on September 17, 1999, consisted of many program elements designed to enhance and improve the unregulated contaminant monitoring program in several important ways. The rule specifies (1) which systems must monitor, including a statistical approach to select a representative sample of small public water systems; (2) a list of contaminants for which systems must monitor; (3) the monitoring time, frequency, and location of sampling; (4) methods to be used for analyzing the contaminants; (5) reporting requirements; and (6) State and Tribal participation concerning the implementation of the monitoring program. EPA divided the list of contaminants for which systems must monitor into three separate lists based on the availability of analytical methods. List 1, Assessment Monitoring, consisted of 12 contaminants for which analytical methods were available at the time the rule was promulgated, with the exception of perchlorate and acetochlor. List 2, Screening Survey, consisted of 16 contaminants for which analytical methods are expected to be developed by the time of initial monitoring in 2001. List 3, Pre-Screen Testing, consisted of 8 contaminants for which analytical methods research is being conducted. Only the contaminants on List 1 must be monitored at all 2,774 large community and non-transient non-community public water systems serving more than 10,000 persons and at a representative sample of approximately 800 systems serving 10,000 or fewer persons. EPA believed that this three- tiered approach to the UCMR, which was recommended by stakeholders, reflected a balance between the implementability of current analytical methods and the need to obtain data in time frames that are useful for responding to concerns about the contaminants identified. Although methods were not available at the time of publication, perchlorate and acetochlor were both included on List 1, Assessment Monitoring, because EPA was engaged in the final validation of their analytical methods. EPA felt that, with the validation, the analytical methods would be sufficiently ready for monitoring by 2001. Therefore, these contaminants were added to List 1, Assessment Monitoring. Today's rule publishes the analytical methods, minimum reporting levels, and sampling locations for perchlorate and acetochlor. This rule will enable monitoring of these contaminants to begin with all the other List 1, Assessment Monitoring contaminants in 2001. As required in the September 1999 UCMR, surface water systems will monitor for perchlorate and acetochlor quarterly for one year and ground water systems will monitor twice in one year. Assessment Monitoring must be done within the three years of 2001 to 2003, which will allow coordination with the three-year compliance monitoring cycle for regulated contaminants. One of these quarterly or semiannual sampling events must occur in the most vulnerable period of May through July, or an alternate vulnerable period designated by the State, to ensure monitoring of elevated contaminant concentrations. B. Systems Affected by This Rule The UCMR states that monitoring in the rule focuses on the occurrence or likely occurrence of contaminants in drinking water of community and non-transient, non-community water systems. For regulatory purposes, public water systems are categorized as ``community water systems'' or ``non-community water systems''. Community water systems are specifically defined as ``public water systems which serve at least 15 service connections used by year-round residents or regularly serve at least 25 year round residents.'' (40 CFR 141.2) A ``non-community water system'' means any other public water system. Non-community water systems include non-transient non- community water systems and transient non-community water systems. Non- transient non-community systems are those that regularly serve at least 25 of the same persons over 6 months per year (e.g., schools, industrial buildings). Transient systems are all other non-community systems, which typically serve a transient population such as restaurants or hotels. In the September 1999 UCMR, EPA excluded transient water systems from this monitoring. The variation in the 97,000 transient systems would be difficult to reflect in a national representative sample and would be very costly to monitor. The results from the very small community and non-transient non-community systems can be extrapolated to the transient non-community systems. With respect to size, about 2,800 large systems (defined here as those serving more than 10,000 persons) provide drinking water to about 80 percent of the US population served by public water systems. The SDWA does not provide for EPA funding of this monitoring. Under the UCMR program all large systems will be required to monitor for unregulated contaminants. Only a representative sample of systems serving 10,000 persons or fewer will be required to monitor for unregulated contaminants. SDWA requires EPA to pay for the reasonable testing costs for the representative sample of small systems. C. Analytical Methods 1. Perchlorate. In today's rule, EPA is amending the September 1999 UCMR to include EPA Method 314.0 ``Determination of Perchlorate in Drinking Water Using Ion Chromatography, Revision 1 (November 1999)'' for the analysis of perchlorate. In this method, perchlorate is separated and measured, using a system comprised of an ion chromatographic pump, sample injection valve, guard column, analytical column, suppressor device, and conductivity detector. This method recommends an ion chromatography (IC) column and analytical conditions which were determined to be the most effective for the widest array of sample matrices. The development of Method 314.0 included investigations into the performance of alternate 4 millimeter IC guard and analytical separator columns which are specified for the IC analysis of perchlorate specified by the California Department of Health Services and also by Dionex [[Page 11375]] Corporation. These alternate guard /separator columns included the Dionex AG5/AS5 and the Dionex AG11/AS11, respectively. The AG5/AS5 is currently specified in the standard operating procedure (SOP) for the IC analysis of perchlorate written by the State of California, Department of Health Services. The AG5/AS5 is a hydrophilic analytical column which was developed several years ago for higher valence anions such as tripolyphosphate and trimetaphosphate as well as polarizable anions such as iodide, thiocyanate and thiosulfate. The AG11/AS11 is used by several commercial laboratories conducting IC analysis for perchlorate and is recognized by California as an acceptable alternate to the AG5/AS5. A multi-laboratory validation study included both of these analytical columns and indicated comparable results could be attained. In the Agency's studies, both the AG5/AS5 and the AG11/AS11 performed well for reagent water and simulated drinking water samples with low to moderate common anion levels, such as sulfate, chloride and carbonate, but as these levels increased, performance began to diminish for both columns. The more recently developed AG16/AS16 columns could tolerate much higher levels of these anions and are therefore recommended in Method 314.0 as the columns of choice although alternate columns such as the AS5 and AS11 are permitted to be used. The Agency's primary reason for publishing Method 314.0 instead of simply approving the published SOPs was the impact of high concentrations of total dissolved solids (TDS); primarily sulfate, carbonate, and chloride on the accuracy of perchlorate determinations. Neither the California Department of Health Services nor the Dionex Corporation method incorporate a quality control element to assess the impact of high concentrations of TDS. Sample matrices with high concentrations of common anions such as chloride, sulfate and carbonate can make the analysis problematic by destabilizing the baseline in the retention time window for perchlorate. This is evidenced by observing a protracted tailing following the initial elution of the more weakly retained anions which extends into the perchlorate retention time window. These common anion levels can be indirectly assessed by monitoring the conductivity of the matrix. Consequently, Method 314.0 specifies that all sample matrices must be monitored for conductivity prior to analysis. When the laboratory determined Matrix Conductivity Threshold (MCT) is exceeded, procedures incorporating sample dilution and/or pretreatment must be performed. The columns and conditions identified in Method 314.0 are recommended since they bear the highest tolerance for the very highest levels of common inorganic anions interference; however, use of the columns and conditions recommended in other ion chromatographic methods for the analyses of perchlorate are also permitted as long as they meet the performance criteria specified in Method 314.0. In addition to recommending the AG16/AS16 column used in Method 314.0, the primary advantages of Method 314.0 are the requirements associated with determining the matrix conductivity threshold (MCT) and reducing the impact of TDS on the accuracy of perchlorate determinations. The MCT is the highest permitted conductance of an unknown sample matrix, measured prior to conducting the analysis, which is used to determine when sample matrix dilution or pretreatment is required. The conductance of a sample matrix is proportional to the common anions present in the matrix (which contribute to the TDS level) which can greatly affect the integrity of this analysis. The MCT is dependent upon the chromatographic column used, its age and condition, the instruments used, and the analyst. Consequently, this threshold is not method defined and must be determined by the individual analytical laboratory during the initial demonstration of capability and confirmed in each analysis batch using an instrument performance check solution. At EPA's laboratory the MCTs determined varied from approximately 3000 microsiemens per centimeter (uS/cm) for the AS5 and AS11 columns to approximately 6000 uS/cm for the AS16 column. Instructions on how to determine a laboratory's MCT are included in EPA Method 314. Both pretreatment cartridges and, in some cases, sample dilution can be effective as a means to eliminate or minimize the impact of certain matrix interferences. With any proposed pretreatment, Method 314.0 specifies that the analyst must verify that the target analyte is not affected by monitoring recovery after pretreatment and that no background contaminants are introduced by the pretreatment. Use of advanced analytical separator column technology which employs higher capacity anion exchange resins, such as the AG16/AS16 which is recommended in Method 314.0, greatly reduces the need for these cartridges. 2. Acetochlor. Several commenters on the proposed UCMR revisions asserted that acetochlor could be reliably measured using EPA Method 525.2. At the time that EPA issued the final UCMR, EPA did not have available the laboratory data necessary to support those assertions. In addition, no data were available concerning the sample and extract storage stability of acetochlor when stored under the preservation conditions specified in EPA Method 525.2. Since that time, EPA has obtained those data necessary to support approval of EPA Method 525.2 for the analysis of acetochlor. Today's rule, therefore, amends the September 1999 UCMR to specify this method for acetochlor analysis. 3. Quality Control and Analytical Confirmation. Additional guidance for quality control and analytical confirmation are specified in a supplement to the ``Supplement to UCMR Analytical Methods and Quality Control Manual'', available by the time this rule is published. D. Peer Review EPA conducted two separate peer reviews, one for the perchlorate method and the other to determine if acetochlor could be added to EPA Method 525.2. The results of the peer review are summarized here: 1. Perchlorate. The peer review for EPA Method 314.0 was conducted in early November 1999 by three experts, external to the EPA and familiar with perchlorate issues, occurrence, and monitoring. All three peer reviewers concluded the method was ``acceptable after minor revision''. The majority of comments were editorial, requiring either typographical editing or further text clarification and explanation. All reviewers provided either verbal or written support for including the MCT as a quality control parameter used to monitor matrix conductance as it relates to reducing interference problems associated with high TDS levels. 2. Acetochlor. In November 1999, EPA provided peer reviewers with a memorandum titled ``Documentation of Agency Decisions Concerning the Analyses of Acetochlor in the Unregulated Contaminant Monitoring Regulation''. This memorandum detailed the minimum detection level, precision and accuracy, analyte stability, and current health effects information that was used in the decision to approve EPA Method 525.2 for the analysis of acetochlor in the UCMR, and to set the Minimum Reporting Level (MRL) at 2 ug/L. This [[Page 11376]] memorandum was reviewed by three methods experts external to the Agency, with one reviewer representing a State and the other two reviewers representing drinking water utilities. All three were supportive of the Agency's decision to approve EPA Method 525.2 for the analysis of acetochlor, and with the decision to set the MRL at 2 ug/L. Reports of these peer reviews and our responses to their comments are in the docket referred to above under ADDRESSES. E. Laboratory Approval and Certification 1. Perchlorate. In order to allow data on perchlorate occurrence in PWSs that were obtained prior to January 2001 to be grandparented, the data must meet the reporting requirements of the UCMR which include the successful completion of the perchlorate PT Program by a laboratory approved to perform the original analyses. Approximately 2,800 large PWSs that serve more than 10,000 persons will be required to monitor for perchlorate using an approved laboratory. For the small PWSs serving 10,000 or fewer persons, EPA will contract with an approved laboratory for perchlorate laboratory analysis. Since this rule specifies the approved analytical method for analyses of perchlorate and is a new method which includes matrix specific quality control criteria, laboratories must go through a separate approval process to test for perchlorate. Laboratories certified under 40 CFR 141.28 for compliance analysis using the EPA analytical methods specified in the UCMR (1999) List, whether the laboratory uses EPA or non-EPA analytical methods on the List, are automatically certified to do analyses of UCMR List 1 contaminants using the listed methods for which it is certified, with the exception of perchlorate. Those laboratories interested in performing perchlorate testing must be previously certified (by the primacy agency in the State where the laboratory is located) to conduct laboratory analysis supporting regulatory compliance monitoring of drinking water for any inorganic anion using an approved ion chromatographic method (such as nitrate analysis by EPA Method 300.0). In addition, the laboratory must successfully complete the perchlorate Performance Testing (PT) Program. This PT Program involves a blind control study, using a test sample with an unknown value. Any laboratory, wishing to participate in the perchlorate PT Program and obtain approval, must submit a letter requesting this information to EPA, received no later than March 31, 2000. Any interested laboratory which does not meet this deadline or fails to successfully pass this initial PT study and still wishes to support this monitoring, will need to submit a request letter by October 6, 2000 in order to be eligible for a second PT study. EPA will not be able to consider any laboratory request letters received after October 6, 2000 and does not intend to conduct any additional PT studies. Any laboratory gaining approval in the first PT study will not be required to participate in the second PT study. These will be the only two PT studies offered for laboratories wishing to gain approval to conduct perchlorate analysis in support of UCMR assessment monitoring. Any laboratory which does not request participation by October 6, 2000 and fails to pass either of these two PT studies will not be approved to support this perchlorate monitoring. The submitted request letter must be signed by the laboratory manager with a statement that the laboratory is currently certified, by the primacy agency in which the laboratory is located, to perform drinking water compliance monitoring using an approved ion chromatographic method. A copy of the letter or certificate issued by the State or primacy agency detailing this certification must also be submitted. Details pertaining to laboratory certification can be found on-line at www.epa.gov/OGWDW/labcint.html. A laboratory's request letter must include the following information: (1) Laboratory Name. (2) Complete Laboratory Mailing Address. (3) Ion chromatography analytical method the laboratory is certified to perform. (4) A copy of the letter or certificate issued by the State or primacy agency which issued the certification to the laboratory. (5) Contact Person. (6) Contact Phone, FAX, and e-mail (if available). The letter should be mailed to: Perchlorate PT Program Coordinator, U.S.EPA, MLK 140, 26 W. Martin Luther King Dr., Cincinnati, Ohio 45268. To participate successfully in this program the laboratory will also need to become proficient in the application of U.S. EPA Method 314.0, ``Determination of Perchlorate in Drinking Water Using Ion Chromatography''. Laboratories must follow the procedure as well as all the QC protocols prescribed in the method. To obtain a copy of EPA Method 314.0, contact the Safe Drinking Water Hotline at 1-800-426-4791 or access an electronic copy of the method directly on-line at www.epa.gov/safewater/methods/sourcalt.html. Upon successful completion of the perchlorate PT Program, EPA will provide each successful laboratory with an approval letter identifying the laboratory by name and the approval date. This letter may then be presented to any Public Water System (PWS) as evidence of laboratory approval for perchlorate analysis supporting the UCMR. Laboratory approval is retained as long as the laboratory maintains certification by the State or primacy agency in which the laboratory is located, to perform drinking water compliance monitoring using an approved ion chromatographic method. If a laboratory maintains this certification, the laboratory approval for perchlorate analysis supporting the UCMR will be limited to the time period beginning on the date specified in the EPA issued approval letter and extending through January 28, 2004. Additionally, EPA will establish a website indicating which laboratories are approved to conduct perchlorate monitoring. 2. Acetochlor. No performance testing sample analyses are required for laboratory approval for the analysis of acetochlor under the UCMR. All laboratories currently certified to perform drinking water compliance monitoring using EPA Method 525.2 are automatically approved to perform acetochlor analysis in the UCMR. F. Implementation Implementation of this rule will allow monitoring for perchlorate and acetochlor using the specified methods in this rule. Systems will follow the monitoring requirements described in the September 1999 UCMR at the designated sampling location four times a year for surface water systems, or two times six months apart for ground water systems, with one of the sampling times during the May-July vulnerable time, or an alternate vulnerable period specified by the State. G. Performance-based Measurement System EPA's Office of Water plans to implement a performance-based measurement system (PBMS) that would allow the option of using either performance criteria or reference methods in its drinking water regulatory programs, removing the requirement that only EPA-specified and approved analytical methods be used in SDWA regulatory programs. The requirement to use approved methods for SDWA [[Page 11377]] regulatory programs would, however, be maintained for certain method- defined analytes (e.g., Total Coliform and asbestos), and for data gathering prospective to regulation, such as the contaminant monitoring in this rule. As noted above, many of the contaminants of interest for the Unregulated Contaminant Monitoring (UCM) program can be classified as ``emerging'and thus do not have existing performance criteria or reference methods. In addition to collecting information about contaminant occurrence, the UCM program will enable the development of reference methods and performance criteria. UCM testing will provide data to assist the Agency in developing performance criteria that would be proposed with the MCL, monitoring requirements, etc. for an analyte. For these reasons, the Agency is specifying the method to be used for UCM testing. Once, however, a contaminant proceeds to regulation development as a National Primary Drinking Water Regulation, EPA expects to have sufficient data and method development information to be able to propose both performance criteria and a validated reference method, either of which could be used for compliance monitoring of the contaminant. III. Technical Changes and Clarification to Sec. 141.40 After reviewing the UCMR subsequent to its publication in the Federal Register on September 17, 1999, EPA found five changes that should be made to correct or clarify the wording of the regulation. These changes are at Sec. 141.40 (a)(5)(ii)(C), (a)(5)(iii)(G), (b)(1)(i), and (b)(1)(vii) and described here. A. Change to Sec. 141.40 (a)(5)(ii)(C) This paragraph describes the location at which unregulated contaminant monitoring is to occur. However, the paragraph provides an exception where a State determines that no treatment is instituted between the source water and the distribution system that would affect measurement of the contaminants listed in Sec. 141.40 (a)(3). EPA is correcting this provision to delete redundant wording that does not help to clarify the exception. B. Change to Sec. 141.40 (a)(5)(ii)(G) This paragraph describes the requirements for testing of the contaminants listed in Sec. 141.40 (a)(3) by a certified laboratory. This paragraph states that laboratories certified to conduct compliance analysis using EPA analytical methods in column 3, Sec. 141.40 (a)(3), may conduct analyses for the UCMR contaminants. EPA is adding a paragraph to address laboratory approval to analyze for perchlorate in drinking water samples. C. Change to Sec. 141.40 (a)(5)(iii)(G) This paragraph specifies that sampling forms must be completed by owners or operators of small systems conducting the sampling for unregulated contaminants before sending the results to the EPA designated laboratory. The data elements that the owner or operator must complete are incorrectly specified as 1 through 6. The rule corrects the language to identify the data elements to be 1 through 4: Public Water System Identification Number; Public Water System Facility Identification Number--Source, Treatment Plant, and Sampling Point; Sample Collection Date; and Sample Identification Number. The rule also corrects the reporting for small systems to include data elements 5 through 10 if water quality parameters are required to be reported from the field. These parameters include: Contaminant/ Parameter; Analytical Results-sign; Analytical Results-Value; Analytical Result-Unit of Measure; Analytical Method Number; and Sample Analysis Type. This clarification makes this section consistent with Sec. 141.40 (a)(4)(i)(B) which applies to all systems analyzing for water quality parameters. D. Change to Sec. 141.40 (b)(1)(i) This paragraph describes the process for States and Tribes to accept or modify the State Monitoring Plans for small systems. The paragraph incorrectly refers to ``distribution line.'' This reference should be to a ``distribution system'' to be consistent with other sections of and the intent of the rule. E. Change to Sec. 141.40 (b)(1)(vii) This paragraph describes the process for a State or Tribe to participate in monitoring for the Screening Surveys for small and large systems. This paragraph contains an exclusion for systems purchasing water (unless the system is to conduct microbiological contaminant monitoring)[emphasis added]. The intent of the exception identified in the parenthetical phrase ``unless the system is to conduct microbiological monitoring'' was to address any contaminants for which the distribution system should be the appropriate location for monitoring, not just microbiological contaminants. The reference to microbiological contaminant monitoring is an artifact of a previous draft of the rule which was not corrected. Today's rule provides the intended wording and allows the exclusion of certain systems ``(unless the system is to conduct monitoring for a contaminant with the sampling location specified as the ``distribution system'').'' F. Clarification of Monitoring for DCPA Mono and Di-Acid Degradate In the September 17, 1999, Federal Register (64 FR 50556), EPA included as separate contaminants both DCPA mono-acid and DCPA di-acid degradates on the UCMR (1999) Monitoring List. As noted in the ``UCMR Analytical Methods and Quality Control Manual,'' August 1999, all of the approved methods identify total mono and di-acid forms as a single analytical result. None of the approved methods allow for the identification and quantification of the individual acids. To provide for the consistent reporting of results and to avoid confusion, EPA is specifying in Table 1 of Sec. 141.40 (UCMR List 1, 1999) that the single analytical result obtained from these methods should be reported as total DCPA mono- and di-acid degradates. IV. Cost and Benefits of the Rule Today's amendment to the UCMR (64 FR 50555) adds methods for monitoring perchlorate and acetochlor to the UCMR (1999) List 1. These contaminants will be collected as part of the Assessment Monitoring component of the UCMR program. Perchlorate and acetochlor were part of the original UCMR (1999) List 1 contaminants, but were withheld from the September 1999 Final Rule pending finalization of their analytical methods. As described elsewhere in this Preamble, Assessment Monitoring will be conducted over a 3-year period from 2001 to 2003 by all 2,774 large PWSs and a randomly selected representative sample of 800 small systems. Since perchlorate and acetochlor will be analyzed by laboratories using water samples that are collected at the same time as the other 10 Assessment Monitoring contaminants, there are no additional labor costs related to today's addition of these contaminants. Systems will only be required to collect one additional sample for perchlorate analysis at the same sampling point where they are collecting the other Assessment Monitoring samples. No measurable added labor burden is associated with filling one more sample bottle. Additional non-labor costs are solely attributed to the laboratory fees/costs associated with analyzing samples for these contaminants. These costs will only be incurred by EPA and by large PWSs. No additional shipping costs will be incurred, since the weight of one sample bottle will not increase the shipment pricing category. [[Page 11378]] EPA assumes that no additional costs will be incurred for analysis of acetochlor, since this contaminant will be analyzed under method 525.2, along with 2,4-dinitrotoluene and 2,6-dinitrotoluene. EPA estimates that the average laboratory fee/cost for perchlorate analysis, using the ion chromotography Method 314.0 will be $60 per sample. The additional costs for laboratory analysis are calculated as follows: the product of the number of systems and the number of entry or sampling points is multiplied by the sampling frequency and then multiplied by the cost of analysis. The details of EPA's cost assumptions and estimates for Assessment Monitoring contaminants, with the exception of perchlorate and acetochlor, can be found in the Information Collection Request (ICR) previously prepared for the UCMR (OMB number 2040-0208), which presents estimated cost and burden for the 1999-2001 period. The Office of Management and Budget (OMB) approved the ICR on June 30, 1999. An inventory correction worksheet (ICW) was prepared for this rule to address the hours and dollars associated with monitoring and analyzing for perchlorate and acetochlor. Copies of the ICR may be obtained from Sandy Farmer by mail at: OP Regulatory Information Division; U.S. Environmental Protection Agency (2137); 401 M St., S.W.; Washington, DC 20460, by email at: [email protected], or by calling: (202) 260- 2740. For technical information regarding the ICR, please contact Chuck Job, U.S. Environmental Protection Agency, (4607); 401 M St., S.W.; Washington DC 20460, by email at: [email protected], or by calling (202) 260-7084. A copy may also be downloaded from the Internet at: http: //www.epa.gov/icr. In preparing the UCMR ICR and the ICW, EPA relied on standard assumptions and data sources used in the preparation of other drinking water program ICRs. These include the public water system inventory, number of entry points per system, and labor rates. To estimate the labor burden for State and some system activities, the Agency used its standard State Resource Model, which is documented in the Resource Analysis Computer Program for State Drinking Water Agencies (January 1993). Other assumptions are discussed below. Over the UCMR implementation period of 2001 through 2005, EPA estimates that the average annual cost of the nationwide addition of perchlorate and acetochlor to Assessment Monitoring is approximately $560,700, as follows: 1. EPA: $70,200, exclusively for the additional testing costs for small systems. 2. States: $0. 3. Small systems: $0. 4. Large systems: $490,500. The estimated average annual cost is approximately $177 per large system. V. Administrative Requirements A. Executive Order 12866--Regulatory Planning and Review Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether a 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 entitlements, 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. Executive Order 13045--Protection of Children From Environmental Health Risks and Safety Risks Executive Order 13045, ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), applies to any rule that (1) is determined to be ``economically significant'' as defined under Executive Order 12866 and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. This Rule is not subject to Executive Order 13045 because it is not ``economically significant'' as defined under Executive Order 12866. Further, this rule is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks. This rule makes purely clarifying changes to the September 1999 UCMR and establishes analytical test methods for measurement of the unregulated contaminants perchlorate and acetochlor. However, this Rule is part of the Agency's overall strategy for deciding whether to regulate the contaminants under the Safe Drinking Water Act (see discussion of the Contaminant Candidate List (CCL) at 63 FR 10273). Its purpose is to ensure that EPA obtains data on the occurrence of contaminants on the CCL--specifically perchlorate and acetochlor--where those data are currently lacking. EPA is also taking steps to ensure that the Agency will have data on the health effects of these contaminants on children through its research program. The Agency will use these occurrence and health effects data to decide whether to regulate these contaminants. 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 UMRA section 202, 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 a rule for which a written statement is needed, UMRA section 205 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 of why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal [[Page 11379]] governments, it must have developed under UMRA section 203 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. EPA has determined that today's rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or for the private sector in any one year. Total annual costs of today's rule (across the implementation period of 2001-2005), for State, local, and tribal governments and the private sector, are estimated to be $560,700, of which EPA will pay $70,200, or approximately 12 percent. Thus, today's rule is not subject to the requirements of UMRA sections 202 and 205. EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments because EPA will pay for the reasonable costs of sample testing for the small PWSs required to sample and test for unregulated contaminants under this rule, including those owned and operated by small governments. Small systems will incur minimal additional labor or non-labor costs as a result of this rule, since laboratory analysis of perchlorate and acetochlor will be conducted using samples that systems were already collecting under the September 1999 UCMR. Thus, today's rule is not subject to the requirements of UMRA section 203. D. Paperwork Reduction Act The Office of Management and Budget (OMB) has approved the information collection requirements contained in this rule under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2040-0208. As part of the September 1999 UCMR, the information to be collected under today's Rule fulfills the statutory requirements of section 1445(a)(2) of the Safe Drinking Water Act, as amended in 1996. The data to be collected will describe the source water, location, and test results for samples taken from PWSs. The concentrations of any identified UCMR contaminants will be evaluated regarding health effects and will be considered for future regulation accordingly. Reporting is mandatory. The data are not subject to confidentiality protection. For a discussion of the costs for the full monitoring program from 2001 through 2005, please refer to Section V., ``Costs and Benefits of the Rule'' in the preamble. EPA has an approved ICR for the 10 UCMR Assessment Monitoring contaminants and is in the process of processing the ICW for the addition of perchlorate and acetochlor methods to the UCMR. This discussion focuses on the estimated costs during the ICR period of 1999-2001. The cost estimates described below for the additional contaminants, perchlorate and acetochlor, are solely attributed to additional laboratory fees/costs. No additional labor or hour burden will be incurred because of the addition of these contaminants to the UCMR (1999) List 1. For Assessment Monitoring, the respondents are the 800 small water systems (in the national representative sample of systems serving 10,000 or fewer people), the 2,774 large public water systems, and the 56 States and primacy agents (3,630 total respondents). The frequency of response varies across respondents and years. However, there are no additional responses associated with this rule amendment, and thus no additional hour burden for any respondents. Minimal additional costs will be incurred by small systems or States. Large systems and EPA will incur the additional laboratory fees/costs for the analysis of perchlorate and acetochlor. For the three year ICR period only, each large system respondent will incur an annual average additional cost of $295. This was calculated by the average cost per system over three years. [E.g., ($884 per large system) divided by three years]. The additional cost for perchlorate and acetochlor is estimated to be $300 per response by a large system. This is calculated by the average cost per system over the three years [E.g., ($884 per large system) divided by the average number of responses per system over the entire three year period (2.9 per large system)]. EPA will incur no additional labor or hour costs for implementation of today's rule. EPA's annual non-labor costs (for the ICR period 1999- 2001) are estimated to be $36,400 for the analysis of small system perchlorate and acetochlor Assessment Monitoring samples. Non-labor costs are solely attributed to the cost of sample testing for the 800 small systems. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and aintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An Agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15. E. Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et seq. The RFA generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. The RFA provides default definitions for each type of small entity. It also authorizes an agency to use alternative definitions for each category of small entity, ``which are appropriate to the activities of the agency'' after proposing the alternative definition(s) in the Federal Register and taking comment. 5 U.S.C. 601(3)-(5). In addition to the above, to establish an alternative small business definition, agencies must consult with SBA's Chief Counsel for Advocacy. For purposes of assessing the impacts of today's rule on all three categories of small entities, EPA considered small entities to be systems serving 10,000 or fewer customers because this is the size of system specified in SDWA as requiring special consideration with respect to small system flexibility. In accordance with the RFA requirements, EPA proposed using this alternative definition for all three categories of small entities in the Federal Register, (63 FR 7605, February 13, 1998) requested public comment, consulted with SBA regarding the alternative definition as it relates to small [[Page 11380]] businesses, and finalized the alternative definition in the Consumer Confidence Reports rulemaking, (63 FR 44511, August 19,1998). As stated in that final rule, the alternative definition would be applied to this regulation as well. For the UCMR, published on September 17, 1999, EPA analyzed separately the impact on small privately and publicly owned water systems because of the different economic characteristics of these ownership types. For publicly owned systems, EPA used the ``revenue test,'' which compares a system's annual costs attributed to the rule with the system's annual revenues. EPA used a ``sales test'' for privately owned systems, which involves the analogous comparison of UCMR-related costs to a privately owned system's sales. EPA assumes that the distribution of the national representative sample of small systems will reflect the proportions of publicly and privately owned systems in the national inventory. The estimated distribution of the representative sample, categorized by ownership type, source water, and system size, is presented below in Table 1. Table 1.--Number of Publicly and Privately Owned Systems To Participate in Assessment Monitoring [Including perchlorate and acetochlor] ---------------------------------------------------------------------------------------------------------------- Publicly owned systems Privately owned ------------------------ systems Size category ------------------------ Total--All Non-index Index Non-index Index systems systems systems systems systems ---------------------------------------------------------------------------------------------------------------- Ground Water Systems ---------------------------------------------------------------------------------------------------------------- 500 and under....................................... 20 1 76 2 99 501 to 3,300........................................ 146 6 67 3 222 3,301 to 10,000..................................... 144 7 40 2 193 ================================================================================================================ Subtotal ground................................. 310 14 183 7 514 ---------------------------------------------------------------------------------------------------------------- Surface Water Systems ---------------------------------------------------------------------------------------------------------------- 500 and under....................................... 18 0 49 0 67 ---------------------------------------------------------------------------------------------------------------- 501 to 3,300........................................ 51 2 23 1 77 3,301 to 10,000..................................... 106 5 30 1 142 Subtotal surface................................ 175 7 102 2 286 ---------------------------------------------------------------------------------------------------------------- Total......................................... 485 21 285 9 800 ---------------------------------------------------------------------------------------------------------------- The basis for the UCMR RFA certification for today's rule, which adds perchlorate and acetochlor to the Assessment Monitoring program, is as follows: the average annual compliance costs of the rule represent less than 1 percent of revenues/sales for the 800 small water systems that will be affected. The EPA estimates that EPA and small system costs for adding perchlorate and acetochlor to the Assessment Monitoring program (2001-2005) will be approximately $350,890. Since the Agency specifically structured the rule to avoid significantly affecting small entities by assuming all costs for laboratory analyses, shipping, and quality control for small entities, EPA incurs the entirety of the costs associated with adding methods for monitoring perchlorate and acetochlor to the Assessment Monitoring list. Table 2 presents the annual costs to EPA for the small system sampling program, along with the number of participating small systems during each of the 5 years of the program. The table also illustrates that no additional costs are incurred by the small systems. Table 2.--EPA Costs for Small Systems for the Addition of Perchlorate and Acetochlor Methods to UCMR Assessment Monitoring ---------------------------------------------------------------------------------------------------------------- Cost description 2001 2002 2003 2004 2005 Total ---------------------------------------------------------------------------------------------------------------- Total Costs to EPA for Small System Sampling of Perchlorate and Acetochlor: analytical costs ---------------------------------------------------------------------------------------------------------------- $109,150 $109,150 $109,150 $11,720 $11,720 $350,890 ---------------------------------------------------------------------------------------------------------------- Costs to Small Systems: no additional labor or non-labor costs incurred ---------------------------------------------------------------------------------------------------------------- $0 $0 $0 $0 $0 $0 ---------------------------------------------------------------------------------------------------------------- Total Costs to EPA and Small Systems for UCMR ---------------------------------------------------------------------------------------------------------------- $109,150 $109,150 $109,150 $11,720 $11,720 $350,890 ---------------------------------------------------------------------------------------------------------------- Number of Systems to be conducting Assessment Monitoring each Year (thus collecting perchlorate and acetochlor samples): Non-Index and Index in 2001-2003, Index only in 2004-20051 ---------------------------------------------------------------------------------------------------------------- Public............................ 182 182 182 107 21 533 ---------------------------------------------------------------------------------------------------------------- Private........................... 104 104 104 81 9 267 Total......................... 286 286 286 188 30 800 ---------------------------------------------------------------------------------------------------------------- 1Total number of systems is 800. All 30 Index systems sample during each year 2001-005. One-third of Non-Index systems sample during each year from 2001-2003. The rows do not add across, because the same 30 Index systems sample during every year of 5-year implementation cycle. [[Page 11381]] After considering the economic impacts of today's direct final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. EPA has determined that the addition of perchlorate and acetochlor to the UCMR data collection will not affect small water utilities. The rationale for this conclusion is that those 800 small PWSs that will participate in Assessment Monitoring will not be required to conduct additional activities related to this rule. Further, EPA will assume all additional costs for testing of the samples for small systems. We have therefore concluded that today's final rule will impose no regulatory burden for small entities. Also, the minor amendments to the UCMR are purely for clarification or correction, and do not impose any costs. F. National Technology Transfer and Advancement Act Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law No. 104-113, Section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. EPA searched for but did not find any voluntary consensus standards for the measurement of acetochlor or perchlorate. Analytical methods for perchlorate have been published by the California Department of Health and by Dionex Corporation, however neither of these methods incorporates a quality control element which assesses the impact of high concentrations of total dissolved solids (TDS), frequently present in water samples. The presence of these high TDS in samples can result in inaccurate quantitation of perchlorate or may even mask its presence. Therefore, EPA developed EPA Method 314.0 for the analysis of perchlorate which incorporates a quality control element that both identifies the presence of high concentrations of TDS and provides a mechanism to reduce their concentrations, thereby permitting accurate quantitation of perchlorate. In addition, EPA's Method 314.0 permits the use of both the California Department of Health and the Dionex procedures within its scope; therefore, laboratories currently using either of these procedures can convert to using EPA Method 314.0 simply by adopting the quality control element specified in EPA Method 314.0 without needing to change any other aspects of their analyses. G. Executive Order 12898--Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations Executive Order 12898, ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations' (February 11, 1994), focuses federal attention on the environmental and human health conditions of minority and low-income populations with the goal of achieving environmental protection for all communities. By seeking to identify unregulated contaminants that may pose health risks via drinking water from all PWSs, this regulation furthers the protection of public health for all citizens, including minority and low-income populations using public water supplies. H. Executive Order 13132--Federalism Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999) requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' Under section 6 of Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation. This final rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This rule merely specifies the analytical methods approved for the measurement of perchlorate and acetochlor in drinking water, thereby allowing these contaminants to be included in the UCMR Assessment Monitoring program and makes other minor corrections to the September UCMR. Thus, the requirements of section 6 of the Executive Order do not apply to this rule. I. Executive Order 13084--Consultation and Coordination with Indian Tribal Governments Under Executive Order 13084, EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to OMB, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments ``to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.'' Today's rule does not significantly or uniquely affect the communities of Indian tribal governments nor does it impose substantial direct compliance costs on them. Only one tribal water system serves more than 10,000 persons. All the other tribal water systems serve 10,000 or fewer persons, and in today's rule have an equal probability of being selected in the national representative sample of small systems, for which EPA will pay the costs of unregulated contaminant testing. Thus, these tribal water systems will be treated the same as water systems of a State and the impact of the rule on them will not be significant. [[Page 11382]] This rule will not impose substantial direct compliance costs on such communities because, with the exception of the one large tribal water system, the Federal government will provide most of the funds necessary to pay the direct costs incurred by tribal governments in complying with the rule. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule. J. Administrative Procedure Act EPA is publishing this methods rule without prior proposal because it views this as a noncontroversial amendment and anticipates no adverse comment. While developing these methods, EPA worked closely with those people involved in similar work or developing similar methods. For perchlorate, Method 314.0 is an adaptation of the current methods available to test for perchlorate, but with additional QC requirements. For the UCMR, public comment indicated that EPA Method 525.2 could perform analyses for acetochlor. However, elsewhere in this issue of the Federal Register, EPA is publishing a separate document that will serve as the proposal for the Unregulated Contaminant Monitoring Regulation for Public Water Systems; Analytical Methods for Perchlorate and Acetochlor if adverse comments are filed. This rule will be effective on January 1, 2001, without further notice unless EPA receives adverse comment by April 3, 2000. If EPA receives adverse comment, we will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Finally, the minor amendments made to the September 1999 UCMR in today's rule are purely clarifying changes and thus public comment is unnecessary under the Administrative Procedure Act. 5 U.S.C. 553(b)(3)(B). K. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit 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 United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a ``major rule'' as defined by U.S.C. 804(2). This rule will be effective January 1, 2001. VI. Public Involvement in Regulation Development EPA's Office of Ground Water and Drinking Water has developed a process for stakeholder involvement in its regulatory activities to provide early input to regulation development. Today's rule amends the September 1999 UCMR, by establishing the method requirements for perchlorate and acetochlor. At the time of UCMR publication--September 1999--the methods for these contaminants were still under review by the EPA. For a description of public involvement activities please see the discussion at 64 FR 50556. List of Subjects in 40 CFR Part 141 Environmental protection, Chemicals, Incorporation by reference, Indian-lands, Intergovernmental relations, Reporting and recordkeeping requirements, Water supply. Dated: February 23, 2000. Carol M. Browner, Administrator. For the reasons set out in the preamble, title 40, chapter I of 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-l, 300g-2, 300g-3, 300g-4, 300g- 5, 300g-6, 300j-4, 300j-9, and 300j-11. 2. Effective January 1, 2001 Sec. 141.40 as revised on 9/17/99 (64 FR 50556) and effective January 1, 2001 is further amended by: a. Revising Table 1, List 1, in paragraph (a)(3) and revising the column heading notations and footnotes at the end of paragraph (a)(3); b. Revising paragraphs (a)(5)(ii)(C) and (a)(5)(ii)(G); c. Revising paragraph (a)(5)(iii)(G); d. Revising paragraph (b)(1)(i); and e. Revising paragraph (b)(1)(vii). The Revisions read as follows: Sec. 141.40 Monitoring requirements for unregulated contaminants. (a) * * * (3) * * * [[Page 11383]] Table 1.--Unregulated Contaminant Monitoring Regulation (1999) List [List 1--Assessment Monitoring Chemical Contaminants] ---------------------------------------------------------------------------------------------------------------- 6--Period during 2--CAS 3--Analytical 4--Minimum 5--Sampling which 1--Contaminant registry methods reporting location monitoring number level to be completed ---------------------------------------------------------------------------------------------------------------- 2,4-dinitrotoluene..................... 121-14-2 EPA 525.2a 2 ug/Le EPTDSf 2001-2003 2,6-dinitrotoluene..................... 606-20-2 EPA 525.2a 2 ug/Le EPTDSf 2001-2003 Acetochlor............................. 34256-82-1 EPA 525.2a 2 ug/Lo EPTDSf 2001-2003 DCPA mono-acid degradaten.............. 887-54-7 EPA 515.1a 1 ug/Le EPTDSf 2001-2003 EPA 515.2a D5317-93b AOAC 992.32c DCPA di-acid degradaten................ 2136-79-0 EPA 515.1a 1 ug/Le EPTDSf 2001-2003 EPA 515.2a D5317-93b AOAC 992.32c 4,4'-DDE............................... 72-55-9 EPA 508a 0.8 ug/Le EPTDSf 2001-2003 EPA 508.1a EPA 525.2a D5812-96b AOAC 990.06c EPTC................................... 759-94-4 EPA 507a 1 ug/Le EPTDSf 2001-2003 EPA 525.2a D5475-93b AOAC 991.07c Molinate............................... 2212-67-1 EPA 507a 0.9 ug/Le EPTDSf 2001-2003 EPA 525.2a D5475-93b AOAC 991.07c MTBE................................... 1634-04-4 EPA 524.2a 5 ug/Lg EPTDSf 2001-2003 D5790-95b SM 6210Dd SM 6200Bd Nitrobenzene........................... 98-95-3 EPA 524.2a 10 ug/Lg EPTDSf 2001-2003 D5790-95b SM6210Dd SM6200Bd Perchlorate............................ 14797-73-0 EPA 314.0 4 ug/Lo EPTDSf 2001-2003 Terbacil............................... 5902-51-2 EPA 507a 2 ug/Le EPTDSf 2001-2003 EPA 525.2a D5475-93b AOAC 991.07c * * * * * * * ---------------------------------------------------------------------------------------------------------------- Column headings are: 1--Chemical or microbiological contaminant: the name of the contaminants to be analyzed. 2--CAS (Chemical Abstract Service Number) Registry No. or Identification Number: a unique number identifying the chemical contaminants. 3--Analytical Methods: method numbers identifying the methods that must be used to test the contaminants. 4--Minimum Reporting Level: the value and unit of measure at or above which the concentration or density of the contaminant must be measured using the Approved Analytical Methods. 5--Sampling Location: the locations within a PWS at which samples must be collected. 6--Years During Which Monitoring to be Completed: The years during which the sampling and testing are to occur for the indicated contaminant. The procedures shall be done in accordance with the documents listed below. The incorporation by reference of the following documents listed in footnotes b-d and m 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. aThe version of the EPA methods which you must follow for this Rule are listed at Sec. 141.24 (e). bAnnual Book of ASTM Standards, 1996 and 1998, Vol. 11.02, American Society for Testing and Materials. Method D5812-96 is located in the Annual Book of ASTM Standards, 1998, Vol. 11.02. Methods D5790-95, D5475-93, and D5317-93 are located in the Annual Book of ASTM Standards, 1996 and 1998, Vol 11.02. Copies may be obtained from the American Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken, PA 19428. cOfficial Methods of Analysis of AOAC (Association of Official Analytical Chemist) International, Sixteenth Edition, 4th Revision, 1998, Volume I, AOAC International, First Union National Bank Lockbox, PO Box 75198, Baltimore, MD 21275-5198. 1-800-379-2622. [[Page 11384]] dSM 6210 D is only found in the 18th and 19th editions of Standard Methods for the Examination of Water and Wastewater, 1992 and 1995, American Public Health Association; either edition may be used. SM 6200 B is only found in the 20th edition of Standard Methods for the Examination of Water and Wastewater, 1998. Copies may be obtained from the American Public Health Association, 1015 Fifteenth Street NW, Washington, DC 20005. eMinimum Reporting Level determined by multiplying by 10 the least sensitive method's minimum detection limit (MDL=standard deviation times the Student's T value for 99% confidence level with n-1 degrees of freedom), or when available, multiplying by 5 the least sensitive method's estimated detection limit (where the EDL equals the concentration of compound yielding approximately a 5 to 1 signal to noise ratio or the calculated MDL, whichever is greater). fEntry Points to the Distribution System (EPTDS), After Treatment, representing each non-emergency water source in routine use over the twelve-month period of monitoring; sampling must occur at the EPTDS, unless the State has specified other sampling points that are used for compliance monitoring 40 CFR 141.24 (f)(1), (2), and (3). See 40 CFR 141.40(a)(5)(ii)(C) for a complete explanation of requirements, including the use of source (raw) water sampling points. gMinimum Reporting Levels (MRL) for Volatile Organic Compounds (VOC) determined by multiplying either the published Method Detection Limit (MDL) or 0.5 ug/L times 10, whichever is greater. The MDL of 0.5 ug/L (0.0005 mg/L) was selected to conform to VOC MDL requirements of 40 CFR 141.24(f)(17(E). hTo be Determined at a later time. iCompound currently not listed as a contaminant in this method. Methods development currently being conducted in an attempt to add it to the scope of this method. jMethods development currently in progress to develop a solid phase extraction/high performance liquid chromatography/ ultraviolet method for the determination of this compound. kCompound listed as being a contaminant using EPA Method 525.2; however, adequate sample preservation is not available. Preservation studies currently being conducted to develop adequate sample preservation. lMethods development currently in progress to develop a solid phase extraction /gas chromatography /mass spectrometry method for the determination of this compound. mMethod 314.0, ``Determination of Perchlorate in Drinking Water Using Ion Chromatography,'' Revision 1.0, EPA 815-B-99-003, November 1999. Available by requesting a copy from the EPA Safe Drinking Water Hotline within the United States at (800) 426-4791 (Hours are Monday through Friday, excluding federal holidays, from 9:00 a.m. to 5:30 p.m. Eastern Time). Alternately, the method can be assessed and downloaded directly on-line at www.epa.gov/safewater/methods/sourcalt.html. nThe approved methods do not allow for the identification and quantification of the individual acids, the single analytical result obtained should be reported as total DCPA mono- and di-acid degradates. oMRL was established at a concentration, which is at least 1/4th the lowest known adverse health concentration, at which acceptable precision and accuracy has been demonstrated in spiked matrix samples. * * * * * (5) * * * (ii) * * * (C) Location. You must collect samples at the location specified for each listed contaminant in column 5 of the Table 1, UCMR (1999) List, in paragraph (a)(3) of this section. The sampling location for chemical contaminants must be the entry point to the distribution system or the compliance monitoring point specified by the State or EPA under 40 CFR 141.24 (f)(1), (2), and (3). If the compliance monitoring point as specified by the State is for source (raw) water and any of the contaminants in paragraph (a)(3) of this section are detected, then you must also sample at the entry point to the distribution system at the frequency indicated in paragraph (a)(5)(ii)(B) of this section with the following exception: If the State or EPA determines that no treatment was instituted between the source water and the distribution system that would affect measurement of the contaminants listed in paragraph (a)(3) of this section, then you do not have to sample at the entry point to the distribution system. * * * * * (G) Testing. Except as provided in paragraph (a)(5)(ii)(G)(2) of this section for new methods, you must arrange for the testing of the contaminants by a laboratory certified under Sec. 141.28 for compliance analysis using the EPA analytical methods listed in column 3 for each contaminant in Table 1, Unregulated Contaminant Monitoring Regulation (1999) List, in paragraph (a)(3) of this section, whether you use the EPA analytical methods or non-EPA methods listed in Table 1. (1) Laboratory certification for previously approved methods used for the UCMR. Laboratories are automatically certified for the analysis of UCMR contaminants if they are already certified to conduct compliance monitoring for a contaminant included in the same method being approved for UCMR analysis. (2) Laboratory approval for new methods used for the UCMR. To receive approval to conduct analyses for perchlorate, you must be certified to conduct compliance monitoring using an approved ion chromatographic method as listed in Sec. 141.28 and you must analyze and successfully pass the Performance Testing (PT) Program administered by EPA. (iii) * * * (G) Sampling forms. You must completely fill out the sampling forms sent to you by the laboratory, including the data elements 1 through 4 listed in Sec. 141.35(d) for each sample. If EPA requests that you conduct field analysis of water quality parameters specified in paragraph (a)(4)(i)(B) of this section, you must also complete the sampling form to include the information for data elements 5 through 10 listed in Sec. 141.35(d) for each sample. You must sign and date the sampling forms. * * * * * (b) * * * (1) * * * [[Page 11385]] (i) Accept or modify the initial plan. EPA will first specify the systems serving 10,000 or fewer persons by water source and size in an initial State Monitoring Plan for each State using a random number generator. EPA will also generate a replacement list of systems for systems that may not have been correctly specified on the initial plan. This initial State Monitoring Plan will also indicate the year and day, plus or minus two (2) weeks from the day, that each system must monitor for the contaminants in List 1 of Table 1 of this section, Unregulated Contaminant Monitoring Regulation (1999) List. EPA will provide you with the initial monitoring plan for your State or Tribe, including systems to be Index systems and those systems to be part of the Screening Surveys. Within sixty (60) days of receiving your State's initial plan, you may notify EPA that you either accept it as your State Monitoring Plan or request to modify the initial plan by removing systems that have closed, merged or are purchasing water from another system and replacing them with other systems. Any purchased water system associated with a non-purchased water system must be added to the State Monitoring Plan if the State determines that its distribution system is the location of the maximum residence time or lowest disinfectant residual of the combined distribution system. In this case, the purchased water system must monitor for the contaminants for which the ``distribution system'' is identified as the point of ``maximum residence time'' or ``lowest disinfectant residual,'' depending on the contaminant, and not the community water system selling water to it. You must replace any systems you removed from the initial plan with systems from the replacement list in the order they are listed. Your request to modify the initial plan must include the modified plan and the reasons for the removal and replacement of systems. If you believe that there are reasons other than those previously listed for removing and replacing one or more other systems from the initial plan, you may include those systems and their replacement systems in your request to modify the initial plan. EPA will review your request to modify your State's initial plan. Please note that information about the actual or potential occurrence or non- occurrence of contaminants at a system or a system's vulnerability to contamination is not a basis for removal from or addition to the plan. * * * * * (vii) Participate in monitoring for the Screening Surveys for small and large systems. Within 120 days prior to sampling, EPA will notify you which systems have been selected to participate in the Screening Surveys, the sampling dates, the designated laboratory for testing, and instructions for sampling. You must review the small systems that EPA selected for the State Monitoring Plan to ensure that the systems are not closed, merged or purchasing water from another system (unless the system is to conduct monitoring for a contaminant with the sampling location specified as ``distribution system''), and then make any replacements in the plan, as described in paragraph (b)(1)(i) of this section. You must notify the selected systems in your State of these Screening Surveys requirements. You must provide the necessary Screening Surveys information to the selected systems at least ninety (90) days prior to the sampling date. * * * * * [FR Doc. 00-4761 Filed 3-1-00; 8:45 am] BILLING CODE 6560-50-P