Unregulated Contaminant Monitoring Regulation: Approval of Analytical Method for Aeromonas;

AGENCY:

Environmental Protection Agency.

ACTION:

Proposed rule.

SUMMARY:

Today's rule proposes the analytical method and an associated Minimum Reporting Level (MRL) for the analysis of Aeromonas to support the Unregulated Contaminant Monitoring Regulation's List 2 monitoring of 120 large and 180 small public water systems from January 1, 2003 through December 31, 2003. Only these 300 systems must monitor for Aeromonas. Aeromonas hydrophilia is a bacterium that is indigenous to natural waters. It has been implicated as a cause of traveler's diarrhea and other types of infections. Aeromonas has been observed in drinking water distribution systems, especially in locations with low residual chlorine levels.

Additionally, USEPA proposes to approve USEPA Method 515.4 to support previously required National Primary Drinking Water Regulation (NPDWR) compliance monitoring for 2,4-D (as acid, salts and esters), 2,4,5-TP (Silvex), dinoseb, pentachlorophenol, picloram and dalapon, and USEPA Method 531.2 to support previously required NPDWR monitoring for carbofuran and oxamyl.

Minor formatting changes are being made to the table of methods required to be used for required organic chemical NPDWR compliance monitoring to improve clarity and to conform to the format of other methods tables. In addition, the Presence-Absence (P-A) Coliform Test listed in the total coliform methods table was inadvertently identified as method 9221. This is being corrected to 9221 D. Also, detection limits for “Cyanide” are added in the “Detection Limits for Inorganic Contaminants” table for the two proposed cyanide methods.

Finally, USEPA proposes to approve eight additional industry developed analytical methods to support previously required NPDWR compliance monitoring. These eight methods include: a method for the determination of atrazine, two methods for the determination of cyanide, three methods for the determination of total coliforms, a method for the determination of heterotrophic bacteria and a method for the determination of turbidity.

DATES:

Written comments should be postmarked by midnight, delivered by hand, or electronically mailed on or before May 6, 2002.

ADDRESSES:

Any person may submit written or electronic comments concerning this proposed rule. Please send an original and 3 copies of your comments and enclosures (including references) to the W-01-13 Comment Clerk, Water Docket (MC4101), USEPA, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. Hand deliveries should be delivered to: USEPA's Water Docket at 401 M. St., SW., Room EB57, Washington, DC. Comments may also be submitted electronically to ow-docket@epa.gov.

FOR FURTHER INFORMATION CONTACT:

For information regarding the actions included in this proposal contact David J. Munch, USEPA, 26 West Martin Luther King Dr. (MLK 140), Cincinnati, Ohio 45268, (513) 569-7843 or e-mail at munch.dave@EPA.gov. General information may also be obtained from the USEPA 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 a.m. to 5:30 p.m. Eastern Time.

SUPPLEMENTARY INFORMATION:

Potentially Regulated Entities

The only regulated entities are the 300 public water systems selected for Aeromonas monitoring; the use of the remaining methods proposed for approval in this action is voluntary however, if one of these methods is selected for use for the purpose of compliance monitoring then, compliance with the procedures specified in the method is required. A nationally representative sample of 120 large community and non-transient non-community water systems serving more than 10,000 persons are required to monitor for Aeromonas under the revised UCMR. A nationally representative sample of 180 community and non-transient non-community systems serving 10,000 or fewer persons are also required to monitor for Aeromonas. 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 affected by this action. Categories and entities potentially affected by this action include the following:

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 USEPA 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 facility is potentially regulated by this action concerning the monitoring for Aeromonas, you should carefully examine the applicability criteria in § 141.35 and § 141.40 of the Code of Federal Regulations. A listing of the systems selected to perform Aeromonas monitoring is available at http://www.epa.gov/safewater/standard/ucmr/systems.html. To determine whether your facility is potentially regulated by the action concerning the use of USEPA Methods 515.4, 531.2 or the additional industry developed methods being proposed, you should carefully examine the applicability criteria in § 141.21, § 141.23, § 141.24 and § 141.74 of the Code of Federal Regulations. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

Submitting Comments

Commentors who want USEPA to acknowledge receipt of their comments should enclose a self-addressed, stamped envelope. No facsimiles (faxes) will be accepted. Electronic comments must be submitted as an ASCII, WP5.1, WP6.1 or WP8 file avoiding the use of special characters and forms of encryption. Electronic comments must be identified by the docket number W-01-13. Comments and data will also be accepted on disks in WP 5.1, 6.1, 8 or ASCII file format. Electronic comments on this notice may be filed online at many Federal Depository Libraries. Commentors should use a separate paragraph for each issue discussed.

The record for this proposed rulemaking has been established under docket number W-01-13, and includes all of the supporting documentation, including copies of all of the analytical methods included in this proposed regulation as well as all materials referenced. The record is available for inspection from 9 to 4 p.m., Monday through Friday, excluding legal holidays at the Water Docket, EB 57, USEPA Headquarters, 401 M. St., SW., Washington, DC. For access to docket materials, please call 202/260-3027 to schedule an appointment.

Abbreviations and Acronyms Used in the Preamble and Proposed Rule

2,4-D—2,4-dichlorophenoxyacetic acid

2,4,5-TP—2,4,5 trichlorophenoxyacetic acid

ADA—ampicilin-dextrin

APHA—American Public Health Association

ASTM—American Society for Testing and Materials

CAS—Chemical Abstract Service

CASRN—Chemical Abstract Service Registry Number

CFR—Code of Federal Regulations

CFU/mL—colony forming units per milliliter

DCPA—dimethyl tetrachloroterephthalate, chemical name of the herbicide dacthal

ECD—electron capture detector

USEPA—United States Environmental Protection Agency

EPTDS—entry point to the distribution system

ESA—ethanesulfonic acid, a degradation product of alachlor and other acetanilide pesticides

et al.—and others

GC—gas chromatograph, a laboratory instrument

GLI method—Great Lakes Instruments method

HRGC—high resolution gas chromatography

HRMS—high resolution mass spectrometer

ICR—information collection request

LD—point of lowest disinfectant residual

MCL—maximum contaminant level

MD—midpoint in the distribution system

MDL—method detection limit

MI—4—methylumbelliferyl—beta—D—galactopyranoside'indoxyl—beta—D—glucuronide

μg/L—micrograms per liter

mg/L—milligram per liter

MPN—most probable number

MR—point of maximum retention

MRL—minimum reporting level

MTBE—methyl tertiary-butyl ether, a gasoline additive

NAICS—National American Industry Classification System

NERL—National Environmental Research Laboratory

nm—nanometers

NPDWR—National Primary Drinking Water Regulation

NTIS—National Technical Information Service

NTNCWS—non-transient non-community water system

NTTAA—National Technology Transfer and Advancement Act

OMB—Office of Management and Budget

PCBs—polychlorinated biphenyls pKa—negative logarithm of the acidity constant

pKa—negative logarithm of the acidity constant

PT—performance testing

PWS—public water system

RDX—royal demolition explosive, hexahydro-1,3,5-trinitro-1,3,5-triazine

RFA—Regulatory Flexibility Act

SBREFA—Small Business Regulatory Enforcement Fairness Act

SDWA—Safe Drinking Water Act

UCMR—Unregulated Contaminant Monitoring Regulation

UMRA—Unfunded Mandates Reform Act of 1995

UV—ultraviolet

Table of Contents

I. Regulatory Background

II. Aeromonas Related Actions

A. Relation to the UCMR

B. Contaminant and Analytical Methods

C. Laboratory Approval and Certification

D. Summary of USEPA Method 1605

III. Primary and Secondary Drinking Water Regulation Related Actions

A. Contaminants and Analytical Methods

B. Summary of Primary and Secondary Drinking Water Regulation Methods

IV. Cost 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 13175—Consultation and Coordination with Indian Tribal Governments

J. Plain Language Directive

K. Executive Order 13211—Energy Effects

VI. References

I. Regulatory Background

The Safe Drinking Water Act (SDWA) section 1445(a)(2), as amended in 1996, requires USEPA to establish criteria for a program to monitor unregulated contaminants and to publish a list of contaminants to be monitored. To meet these requirements, USEPA published the Revisions to the Unregulated Contaminant Monitoring Regulation (UCMR) for Public Water Systems in (64 FR 50555, September 17, 1999) which substantially revised the previous Unregulated Contaminant Monitoring Program, codified at 40 CFR 141.40. USEPA subsequently published supplements to the rule, including analytical methods for conducting analysis of List 1 and selected List 2 contaminants (65 FR 11372, March 2, 2000 and 66 FR 2273, January 11, 2001) and technical corrections and other supplemental information (66 FR 27215, May 16, 2001 and 66 FR 46221, September 4, 2001). The January 11, 2001 rule specified the requirements for Aeromonas monitoring in the UCMR; however, an analytical method was not approved to support the required monitoring for Aeromonas which is scheduled to begin on January 1, 2003. Today's rule proposes to amend the UCMR to specify a method and an associated Minimum Reporting Level for monitoring Aeromonas on List 2.

The Safe Drinking Water Act (SDWA), as amended in 1996, requires USEPA to promulgate national primary drinking water regulations (NPDWRs) which specify maximum contaminant levels (MCLs) or treatment techniques for drinking water contaminants (SDWA section 1412 (42 U.S.C. 300g-1)). NPDWRs apply to public water systems pursuant to SDWA section 1401 (42 U.S.C. 300f(1)(A)). According to SDWA section 1401(1)(D), 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, SDWA section 1445(a) authorizes the Administrator to establish regulations for monitoring to assist in determining whether persons are acting in compliance with the requirements of the SDWA. USEPA'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 U.S.C. 300j-9(a)).

Today's action proposes to approve USEPA Method 515.4 for the determination of 2,4-D (as acid, salts and esters), 2,4,5-TP (Silvex), dinoseb, pentachlorophenol, picloram and dalapon; USEPA Method 531.2 for the determination of carbofuran and oxamyl and an additional industry developed method for the determination of atrazine in drinking water using an immunoassay-based technology and colorimetric determination, as required in § 141.24(e) to support monitoring required under § 141.24(h). Today's rule also proposes to approve seven additional industry developed methods: a method using a micro-scale hard distillation apparatus followed by colorimetric determination of total cyanide and a method using an ultra-violet digester system for the determination of total and available cyanide to support monitoring required under § 141.23 (k)(1); two methods for the determination of the presence or absence of total coliforms and E. coli in drinking waters using a liquid culture or membrane filter method, a method for the determination of the presence or absence of total coliforms and E. coli using a liquid culture enzyme-substrate procedure for monitoring required under § 141.21, a method for the determination of heterotrophic bacteria for monitoring and a laser based nephelometric system for the determination of turbidity for monitoring required under § 141.74.

Please note that USEPA is not requesting comment on any aspect of the UCMR other than those changes proposed today. Specifically, USEPA is not requesting comment on the UCMR list of contaminants other than the use of USEPA Method 1605 for the analysis of Aeromonas and the MRL being proposed. USEPA is not seeking comment on any aspect of the monitoring required under § 141.24 other than the applicability of: USEPA Method 515.4 for the analysis of 2,4-D (as acid, salts and esters), 2,4,5-TP (Silvex), dinoseb, pentachlorophenol, picloram and dalapon; USEPA Method 531.2 for the analysis of carbofuran and oxamyl; or the additional industry developed method for the analysis of atrazine. USEPA is not seeking comment on the monitoring required under § 141.21, § 141.23 or § 141.74 beyond the applicability of the seven additional industry developed methods proposed which include: two methods for the determination of cyanide, three methods for the determination of total coliforms and E. coli, a method for the determination of heterotrophic bacteria and a method for the determination of turbidity.

II. Aeromonas Related Actions

A. Relation to the UCMR

Prior actions (66 FR 2273, January 11, 2001 and 66 FR 46221, September 4, 2001), specify the methods to be used for analysis of List 2 chemicals to be monitored in 2001 and 2002. Today's proposal specifies the analytical method and associated MRL for a List 2 contaminant, Aeromonas. Methods for the other two remaining List 2 contaminants, RDX and Alachlor ESA and other acetanilide pesticides, need to be refined for analysis in treated drinking water and thus may be proposed at a later time. The List 2 Rule specified the timing, frequency, and other requirements for Aeromonas monitoring. (66 FR 2273, January 11, 2001) Today's proposal completes the Aeromonas monitoring requirements by specifying the analytical method and MRL.

As specified in these prior actions, USEPA will pay for the shipping, analysis and reporting of results for samples from the 180 small systems serving 10,000 or fewer persons which were selected to conduct this monitoring. The 120 large systems selected to perform this monitoring must arrange and pay for the monitoring, shipping, analysis and reporting of results for Aeromonas samples. Only the 180 small systems and the 120 large systems that were selected must monitor for Aeromonas. No other systems must monitor for Aeromonas. A listing of the systems selected to perform Aeromonas monitoring is available at http://www.epa.gov/safewater/standard/ucmr/systems.html.

As promulgated in the UCMR List 2 Rule (66 FR 2273, January 11, 2001), large systems must use laboratories approved for this analysis. Large PWSs must arrange for the analysis for Aeromonas using USEPA Method 1605, as identified in List 2 of Table 1 (today's action), by a laboratory certified under § 141.28 for compliance analysis using an USEPA-approved membrane filtration method for the analysis of coliform indicator bacteria. As required in § 141.40 (a)(5)(ii)(G)(3), laboratories performing USEPA Method 1605 must participate in and successfully pass one of potentially two performance testing (PT) studies, the first to be conducted by USEPA 45 days after promulgation of this regulation, and a second to be conducted prior to the start of the List 2 Aeromonas monitoring in 2003, time permitting.

B. Contaminant and Analytical Methods

In today's proposal, USEPA is proposing the use of USEPA Method 1605 for the monitoring of Aeromonas as specified in List 2 of Table 1 with an MRL of 0.2 Colony Forming Units (CFU)/100 mL. The proposed MRL is based upon precision data derived during the primary laboratory's methods development and then verified in a second laboratory. Ten laboratories provided precision data using samples, fortified with a single strain of Aeromonas, which were provided by USEPA. The mean precision reported for reagent water samples analyzed by these laboratories was 27% and for finished water samples was 57%.

C. Laboratory Approval and Certification

This rule proposes that laboratories wishing to analyze samples for Aeromonas for the UCMR must use USEPA Method 1605 (described later). USEPA has previously specified, in § 141.40 (a)(5)(ii)(G)(3) (66 FR 2273, January 11, 2001), that Aeromonas analyses must be performed by laboratories certified under § 141.28 for compliance analyses of coliform indicator bacteria using an USEPA approved membrane filtration procedure. Because of differences between USEPA Method 1605 and existing membrane filtration methods for coliform indicator bacteria, laboratories performing USEPA Method 1605 must also participate in performance testing (PT) studies to be conducted by USEPA. Laboratories wishing to be approved to use Method 1605 for this monitoring must submit a “request to participate” letter to USEPA and to analyze 10 samples for Aeromonas using Method 1605. USEPA has established 45 days following the publication of the final rule as the latest date by which it will accept the “request to participate” letter. A second PT study will only be conducted if more than 90 days remain between the reporting of the results of the first study and the beginning of Aeromonas monitoring, January 2003, to provide utilities with at least 45 days to contract with laboratories that have received approval. Upon completion of the Aeromonas PT Program, USEPA will provide each successful laboratory with an approval letter identifying the laboratory by name and the approval date. This letter and a copy of the laboratory's certification under § 141.28 for compliance analysis of coliform indicator bacteria using an USEPA approved membrane filtration procedure, may then be presented to any PWS as evidence of laboratory approval for Aeromonas analysis supporting the UCMR. Laboratory approval is contingent upon the laboratory maintaining certification to perform drinking water compliance monitoring using an approved coliform membrane filtration method. USEPA intends to post a listing of the laboratories that have successfully completed each PT study at www.epa.gov/safewater.

All large and small systems selected for the Screening Survey will be notified by their State Drinking Water Authority or USEPA at least 90 days before the dates established for collecting and submitting UCMR field samples to determine the presence of Aeromonas. Large systems must send samples to approved laboratories and then report the results to USEPA as specified in § 141.35. All small system shipping and analytical costs will be paid by USEPA, however, small systems will be responsible for collecting these samples.

D. Summary of USEPA Method 1605

The proposed Aeromonas method for List 2 monitoring is USEPA Method 1605 “Aeromonas in Finished Water by Membrane Filtration using Ampicillin-Dextrin Agar with Vancomycin (ADA-V),” October 2001 EPA # 821-R-01-034 (see www.epa.gov/microbes or the docket for this proposal for a copy of the proposed method). This method is a membrane filter assay based on the ampicillin-dextrin (ADA) method of Havelaar et al. (1987). The ADA medium has been modified by the addition of vancomycin to inhibit gram positive bacteria including Bacillus species, that may grow on ADA medium, and by the addition of a second stage, which includes three tests for confirmation, cytochrome oxidase, trehalose fermentation, and the production of indole as determined by Kovac's reagent. This method identifies Aeromonas to the genus level and detects A. hydrophila and a majority of the other aeromonad species.

III. Primary and Secondary Drinking Water Regulation Related Actions

A. Contaminants and Analytical Methods

In today's action, USEPA is proposing two new USEPA developed methods and eight additional industry developed methods, for use in National Primary Drinking Water Regulation (NPDWR) monitoring under § 141.24. The proposed methods, and the contaminants (analytes), are shown in Table 1.

USEPA Method 515.4 was previously approved for use for UCMR List 1 contaminants in § 141.40, Table 1 List 1 (66 FR 2273, January 11, 2001), but was not approved for monitoring compliance with NPDWRs. Also, in a supplemental action (66 FR 46221, September 4, 2001), laboratories certified to conduct compliance monitoring using USEPA Method 515.3 were automatically approved to use USEPA Method 515.4 for UCMR analyses. Approving USEPA Method 515.4 for use in NPDWR compliance monitoring will allow public water systems and their laboratories to analyze one water sample for both UCMR and NPDWR purposes, reducing monitoring costs. It will also provide greater method flexibility for monitoring in the long term.

USEPA Method 531.2 improves the sample preservation procedures required in USEPA Method 531.1 and Standard Method 6610 and updates the method performance tables using data generated with more up to date equipment. Use of USEPA Method 531.2 will improve safety for analysts and sample collection personnel by approving the use of a less toxic preservation reagent. Accuracy, precision and detection limit data generated using USEPA Method 531.2 is superior to that generated with either of the currently approved methods. It will also provide greater method flexibility for monitoring in the long term.

For the additional industry developed methods, the submitting organization provided data to support the validation of the new or modified method. The Agency reviewed these validation packages and is proposing those methods that USEPA has determined are satisfactory compliance methods, capable of providing the quality of monitoring data required.

B. Summary of Primary and Secondary Drinking Water Regulation Methods

1. USEPA Method 515.4

USEPA Method 515.4 is a gas chromatography (GC) method for the determination of chlorinated acids in drinking waters. Accuracy, precision, and detection limit data have been generated for the method analytes in reagent water and finished ground and surface waters. Accuracy, precision, and detection limit data generated using USEPA Method 515.4 are equivalent to that generated using USEPA Method 515.3 which is currently approved to perform this monitoring.

USEPA Method 515.4 is applicable to the determination of salts and esters of analyte acids. The form of each acid is not distinguished by this method. Results are calculated and reported for each listed analyte as the total free acid. This method is able to quantify the mono- and di-acid forms of DCPA (Dacthal) without contribution from the parent compound.

A 40-mL volume of sample is adjusted to pH ≥ 12 with 4 Normal (N) sodium hydroxide and allowed to sit for one hour at room temperature to hydrolyze derivatives. Following hydrolysis, a wash step using a hexane: methyl tert-butyl ether (MTBE) mixture is performed as a sample cleanup and to remove Dacthal. The aqueous sample is then acidified with sulfuric acid to a pH of less than 1 and extracted with 4-mL of MTBE. The chlorinated acids that have been partitioned into the MTBE are then converted to methyl esters by derivatization with diazomethane. The target esters are separated and identified by fast capillary column gas chromatography (conditions for standard gas chromatography are also included) using an electron capture detector (GC/ECD). Peer reviews for USEPA Method 515.4 were conducted both within USEPA and by personnel from Montgomery Watson Laboratories, Philadelphia Suburban Water Company, and the American Water Works Service Company. All of the technical peer review comments were positive and the only changes requested were editorial in nature.

USEPA Method 515.4, “Determination of Chlorinated Acids in Drinking Water by Liquid-Liquid Microextraction, Derivatization and Fast Gas Chromatography with Electron Capture Detection,” Revision 1.0, April 2000, USEPA #815/B-00/001, is available from the docket for this proposal or by requesting a copy from the USEPA Safe Drinking Water Hotline at 800-426-4791 (hours are Monday through Friday, excluding Federal holidays, from 9 a.m. to 5:30 p.m. Eastern Time). Alternatively, the method can be accessed and downloaded directly on-line at www.epa.gov/safewater/methods/sourcalt.html. Tables of method validation data are included in the written method.

2. USEPA Method 531.2

USEPA Method 531.2 is a high performance liquid chromatographic (HPLC) method applicable to the determination of certain N-methylcarbamoyloximes and N-methylcarbamates in finished drinking waters. Accuracy, precision, and detection limit data generated using USEPA Method 531.2 are superior to that generated using the currently approved methods, USEPA Method 531.1 or Standard Method 6610.

The water sample is filtered. Method analytes are chromatographically separated by injecting an aliquot (400 to 1000 uL) into a high performance liquid chromatographic (HPLC) system equipped with a reversed phase (C₁₈) column. After elution from the column, the analytes are hydrolyzed in a postcolumn reaction with 0.05 N sodium hydroxide (NaOH) at 80 °C to form methyl amine. The methyl amine is reacted with o-phthalaldehyde (OPA) and 2-mercaptoethanol (or N,N-dimethyl-2-mercaptoethylamine) to form a highly fluorescent isoindole which is detected by a fluorescence detector. Analytes are quantitated using the external standard technique. A second laboratory validation for USEPA Method 531.2 was performed at the American Water Works Service Company and demonstrated good agreement with the performance data generated during the development of the method.

USEPA Method 531.2, “Measurement of N-methylcarbamoyloximes and N-methylcarbamates in Water by Direct Aqueous Injection HPLC with Postcolumn Derivatization,” Revision 1.0, September 2001, is available in the docket for this proposal or by requesting a copy from the USEPA Safe Drinking Water Hotline within the United States at 800-426-4791 (hours are Monday through Friday, excluding Federal holidays, from 9 a.m. to 5:30 p.m. Eastern Time). Tables of method validation data are included in the written method.

3. Syngenta Method AG-625

Syngenta Crop Protection, Inc.'s “Atrazine in Drinking Water by Immunoassay” (Method AG-625) is an additional industry developed method that employs immunoassay technology to determine atrazine in drinking water. Atrazine is determined by using a color-based immunoassay method. Atrazine in a sample is detected by adding sample and enzyme conjugate solution to a culture tube that has been pre-coated with atrazine antibodies. Atrazine competes with the conjugate for antibody binding sites. The culture tube is washed, and an enzyme substrate solution is added. The substrate is enzymatically converted from a colorless to a blue solution, the absorption of which is inversely proportional to atrazine concentration.

Method performance was characterized using data from a 19 laboratory validation study. Average recovery of atrazine from drinking water was 96%, and the relative standard deviation was less than 20%. The stated method detection limit is 0.05 ug/L. Based on these results, USEPA believes that Method AG-625 is a satisfactory compliance method for atrazine in drinking water.

Method AG-625 is available in the docket for this proposal or from Syngenta Crop Protection, Inc. Contact: James Brady, Syngenta Crop Protection, Inc., 410 Swing Road, Post Office Box 18300, Greensboro, NC 27419, telephone (336) 632-6000.

4. QuikChem 10-204-00-1-X

Lachat Instruments “Digestion and Distillation of Total Cyanide in Drinking and Wastewaters using MICRO DIST and determination of cyanide by flow injection analysis” (QuikChem Method 10-204-00-1-X) is an additional industry developed method that determines total cyanide in drinking water. The method employs the MICRO DIST apparatus, a reduced volume disposable distillation apparatus. MICRO DIST reduces distillation time, sample and reagent wastes, and allows for multiple distillations simultaneously (one distillation heating block accommodates 21 MICRO DIST distillation devices).

Total cyanide is determined by distilling the sample and measuring cyanide generated using colorimetry or some other method for cyanide ion detection. Six milliliters of sample are added to a distillation tube along with standard cyanide distillation reagents (sulfuric acid, magnesium chloride). A cyanide collector tube, which consists of a gas permeable membrane and sodium hydroxide absorber solution, is attached to the distillation tube; the distillation and collector tubes together comprise the MICRO DIST unit. The sample is heated for 1/2 hour, during which hydrogen cyanide gas distills from the sample, passes through the gas permeable membrane, and collects in the sodium hydroxide absorber solution. Using method write-up 10-204-00-1-X, the absorber solution is analyzed using an automated colorimeter; however, the absorber solution may be analyzed using another procedure (e.g., ion selective electrode) as well, provided all precautions in the method write-up are acknowledged (e.g., pH of the absorber solution and standards are adjusted to match).

Method performance was characterized in single laboratory studies, and an eight laboratory validation study. Single laboratory studies, performed by Lachat and by Research Triangle Institute, demonstrated recovery of complex cyanides using MICRO DIST and macro distillations were substantially equivalent by measuring a variety of cyanide complexes using both distillations. The eight laboratory validation study demonstrated that the QuikChem 10-204-00-1-X method is a satisfactory compliance method. Based on these results, USEPA believes that this method is a satisfactory compliance method for total cyanides in drinking water.

Method 10-204-00-1-X is available in the docket for this proposal or from Lachat Instruments, 6645 W. Mill Rd., Milwaukee, WI 53218, USA. Phone: 414-358-4200.

5. Kelada 01

Dr. Nabih Kelada's “Kelada Automated Test Methods for Total Cyanide, Acid Dissociable Cyanide, and Thiocyanate” (Kelada 01), USEPA # 821-B-01-009 is an additional industry developed automated procedure that determines total cyanide and acid dissociable cyanide in drinking water. The procedure makes use of a two-stage sample digestion system to determine total cyanide. A sample is introduced into a flow analysis system. The sample then passes through an irradiation coil, where it is exposed to intense ultraviolet (UV) light from a 550 Watt UV photochemical bulb. The UV light breaks down cyanide complexes (include strong ferro- and ferri-cyanide complexes) to free cyanide. The irradiated sample containing free cyanide then passes though a distillation coil from which the free cyanide is distilled into a flow colorimetry system (similar to that used in USEPA Method 335.4) where cyanide concentration is determined. All complex cyanides determined using total cyanide manual distillations are also determined using the Kelada 01 method.

When the irradiation coil is by—passed “exposing sample only to a distillation coil—“acid dissociable” cyanide is determined. The complexes measured are substantially equivalent to those measured using cyanide amenable to chlorination (CATC) or procedures which measure available cyanide, according to a single laboratory study performed by the Metropolitan Water Reclamation District of Greater Chicago.

The Kelada 01method offers advantages over currently approved methods. First, it reduces analysis time from 1.5 hours (using manual distillation and analysis) to minutes. Second, the method reduces the effects of many chemical interferences encountered using traditional manual distillation methods.

The method was validated in both single laboratory and multi-laboratory validation studies, including studies involving eight laboratories which was conducted by the Metropolitan Water Reclamation District of Greater Chicago and through a multi-laboratory study involving 31 laboratories managed by Environment Canada. Studies showed total and acid dissociable cyanide recoveries from samples between 90% and 110%, and relative standard deviations of less than 10%. The reported lower limit of detection is 0.5 μg/L. Based on these results, USEPA believes that the Kelada 01method is a satisfactory compliance method for total cyanide in drinking water.

The Kelada 01method is available in the docket for this proposal.

6. Readycult® Coliforms 100 Presence/Absence Test

The Readycult® Coliforms 100 Presence/Absence Test simultaneously determines the presence of total coliforms and E. coli, both of which must be monitored under the Total Coliform Rule at § 141.21. The tests involve adding the contents of a blister pack to a 100-mL water sample, followed by incubation at 36 ± 1°C for 24 ± 1 hours. If coliform bacteria are present, the medium changes color from slightly yellow to blue-green. In addition, if E. coli is present, the medium will emit a bright blue fluorescence when subjected to a long wave (366 nm) ultraviolet (UV) light, and will form a red ring when indole reagent is added.

The Readycult test is based upon the detection of three enzymes, β-galactosidase, which is specific to the total coliform group, and β-glucuronidase and tryptophanase, both of which are characteristic of E. coli. For detection of β-galactosidase, the medium contains the chromogenic enzyme substrate 5-bromo-4-chloro-3-indolyl-β-D-galactopyranoside (X-GAL). Upon hydrolysis by β-D-galactosidase, X-GAL releases a chromogenic compound (indigo-blue) that turns the medium from slightly yellow to a blue-green color. For detection of β-glucuronidase, the medium contains the fluorogenic enzyme substrate 4-methyl-umbelliferyl-β-D-glucuronide (MUG). Upon hydrolysis by β-glucuronidase, MUG releases 4-methylumbelliferone that fluoresces when exposed to ultraviolet light. For detection of tryptophanase, the medium contains the enzyme substrate tryptophan. Upon cleavage by tryptophanase, tryptophan releases indole that immediately forms a red ring when Kovac's indole reagent is added directly to the broth. The presence of this red ring confirms the presence of E. coli

USEPA has evaluated false positive and false negative data submitted by the manufacturer and has determined that results obtained with the Readycult test are substantially equivalent to the Agency's previously approved reference method for total coliforms and E. coli, however, USEPA has not yet determined a fully substantiated false negative rate for the USEPA reference method. The manufacturer observed a false-positive error of 7% for total coliforms and 5% for E. coli. (The false-positive error for total coliforms was based upon whether the isolate was also positive in lauryl tryptose broth (LTB) and brilliant green lactose bile broth. The false-positive error for E. coli was based upon whether the isolate was also positive in LTB and EC+MUG.) The false-negative rate, respectively, was 5.1% and 6.86%. Based on these results, USEPA believes that the Readycult test is a satisfactory compliance method for total coliforms and E. coli in drinking water.

The method description for the Readycult test is available in the docket for this proposal or from EM Science (an affiliate of Merck KGgA, Darmstadt Germany), 480 S. Democrat Road, Gibbstown, NJ 08027-1297. Their telephone number is (800) 222-0342.

7. Membrane Filter Technique using Chromocult® Coliform Agar

Chromocult® Coliform Agar is a membrane filter medium that simultaneously determines the presence of total coliforms and E. coli, both of which must be monitored under the Total Coliform Rule at § 141.21. For the test, a 100-mL water sample is passed through the membrane that retains the bacteria. Following filtration, the membrane containing bacterial cells is placed on the media and incubated at 36 ± 1°C for 24 ± 1 h. Salmon to red colonies are recorded as total coliforms (without E. coli). In contrast, dark-blue to violet colonies are recorded as E. coli.

The membrane filter method using Chromocult® Coliform Agar is based upon the detection of three enzymes; β-galactosidase, which is specific to the total coliform group, and β-glucuronidase and tryptophanase, both of which are characteristic of E. coli. For detection of β-galactosidase, the medium contains the chromogenic enzyme substrate 6-chloro-3-indolyl-3-β-D-galactopyranoside (SALMON-GAL). Upon hydrolysis by β-D-galactosidase, SALMON-GAL releases a chromogenic compound (chloroindigo) that forms salmon to red-colored colonies. For detection of β-glucuronidase, the medium contains another chromogenic enzyme substrate, 5-bromo-4-chloro-3-indoxyl-β-D-glucuronic acid, cyclohexylammonium salt (X-GLUC). Upon hydrolysis by β-glucuronidase, X-GLUC releases a chromogenic compound (bromochloroindigo) that forms light-blue to turquoise colonies. E. coli produces both β-galactosidase and β-glucuronidase that cleave both SALMON-GAL and X-GLUC, respectively. The simultaneous hydrolysis of these chromogenic substrates forms dark-blue to violet colonies that are easily distinguished from other coliform colonies. For detection of tryptophanase, the medium contains the enzyme substrate tryptophan. Upon cleavage by tryptophanase, tryptophan releases indole that immediately forms a cherry-red color when Kovac's indole reagent is added directly to dark-blue to violet colonies. This reaction thus confirms the presence of E. coli in dark-blue to violet colonies.

USEPA has evaluated data submitted by the manufacturer and has determined that more positives were reported with Chromocult® Coliform Agar than the Agency's previously approved reference method for total coliforms and E. coli, (USEPA has not yet determined a fully substantiated false negative rate for the USEPA reference method, however, USEPA believes that it is higher than the false negative rate observed for Chromocult® Coliform Agar and that this is responsible for the observed higher positive rate). The manufacturer observed a false-positive error of 13% for total coliforms and 6% for E. coli. (The false-positive error for total coliforms was based on whether the isolate was also positive in lauryl tryptose broth (LTB) and brilliant green lactose bile broth. The false-positive error for E. coli was based on whether the isolate was also positive in LTB and EC+MUG.) The false-negative rate using the Chromocult® Coliform Agar was 0% for both total coliforms and E. coli. Based on these results, USEPA believes that Chromocult® Coliform Agar is a satisfactory medium for use under the Total Coliform Rule to detect total coliforms and E. coli in drinking water.

The method description for Chromocult® Coliform Agar is available in the docket for this proposal or from EM Science (an affiliate of Merck KGgA, Darmstadt Germany), 480 S. Democrat Road, Gibbstown, NJ 08027-1297. Their telephone number is (800) 222-0342.

8. Colitag® Test

The “Colitag® Product as a Test for Detection and Identification of Coliforms and E. coli Bacteria in Drinking Water and Source Water as required in National Primary Drinking Water Regulations” is a liquid culture enzyme-substrate procedure that simultaneously determines the presence of total coliforms and E. coli, both of which must be monitored under the Total Coliform Rule at § 141.21. To determine total coliforms, the Colitag® test medium contains chromogenic enzyme substrate ortho-β-D-galactopyranoside (ONPG) for the detection of β-galactosidase, an enzyme indicative of the coliform group. Upon hydrolysis by β-galactosidase, ONPG produces a distinct yellow color that can be observed visually, indicating the presence of coliforms. To determine E. coli, Colitag medium contains chromogenic enzyme substrate, 4-methyl-umbelliferyl-β-D-glucuronide (MUG) for detection of β-glucuronidase, an enzyme specific to E. coli. Upon hydrolysis by β-glucuronidase, MUG produces the fluorescent compound 4-methylumbelliferone, which fluoresces when exposed to ultraviolet light.

The method differs from currently approved enzymatic methods by the addition of trimethylamine-N-oxide (TMAO) to the list of ingredients. TMAO allows the pH of the medium to increase from 6.2 to 7.0 during incubation, thereby enhancing the recovery of chlorine injured/stressed organisms.

USEPA has evaluated comparability data submitted by the manufacturer and has determined that results obtained with the Colitag® test are statistically equivalent to the Agency's reference method for total coliforms and E. coli, however, USEPA has not yet determined a fully substantiated false negative rate for the USEPA reference method. The manufacturer observed a false-positive error of 2.0% for total coliforms and 2.0% for E. coli. The false-negative rates were 0% and 0%, respectively. Based on these results, USEPA believes that the Colitag® test is a satisfactory compliance method for total coliforms and E. coli in drinking water.

The method description for the Colitag® test is available in the docket for this proposal or from CPI, International, Inc., 5580 Skylane Blvd., Santa Rosa, CA, 95403, telephone (800) 878-7654, Fax (707) 545-7901, e-mail www.cpiinternational.com.

9. SimPlate

Under the Surface Water Treatment Rule (SWTR), § 141, Subpart H, a system using surface water or ground water under the direct influence of surface water must, among other requirements, maintain a disinfectant residual in the distribution system. The disinfectant residual in the distribution system cannot be undetectable in more than 5% of the samples each month, for any two consecutive months that the system serves water to the public. However, § 141.72(b)(3) allows a system that does not detect a residual at a particular site to determine the concentration of heterotrophic bacteria at that site. For compliance purposes, a concentration of 500 colonies/mL or fewer, as measured by the pour plate method (Standard Method 9215), is considered to be equivalent to a detectable disinfectant residual.

Because the measured density of heterotrophic bacteria is method-dependent, USEPA to date has only approved one method. Recently, however, USEPA has determined that another test for heterotrophic bacteria, the SimPlate method, provides results substantially equivalent to the pour plate method, given the intended application. Consequently, the Agency is proposing to approve the SimPlate method as an optional procedure for determining the density of heterotrophic bacteria under § 141.72(b)(3).

SimPlate is a substrate-based medium in which the substrates are hydrolyzed by microbial enzymes causing the release of 4-methylumbelliferone, which fluoresces under 365-nm ultraviolet light. The medium is dehydrated when purchased. Two SimPlate formats are available: a unit-dose format and a multi-dose format. The unit-dose format consists of adding 10-mL of test sample to a test tube containing the dehydrated SimPlate medium, and then pouring the dissolved mixture to the center of a plate containing 84 small wells. In contrast, under the multi-dose format, the dehydrated medium needs to be reconstituted first by filling the medium vessel to the 100-mL mark with sterile diluent, and shaking to dissolve. A 1.0-mL test sample is then pipetted to the center of the plate, followed by 9.0 mL of the reconstituted SimPlate medium. The plate is then gently swirled to mix the sample and medium. The next steps are the same for both formats. The mixture is evenly distributed to the 84 wells on the plate, and the excess liquid drained into an absorbent pad on the plate. The plate is then inverted (the fluid in each well is held in place by surface tension) and incubated for 45-72 hours at 35°C. Bacterial density is determined by counting the number of wells that fluoresce under a 365-nm UV light, and converting this value to a Most Probable Number (MPN) using the table provided, taking into account any dilution factor that may have been used during sample preparation to ensure a proper counting range.

USEPA has evaluated data submitted by the manufacturer from a side-by-side comparison of the SimPlate and the USEPA-approved pour plate method, and has determined that while statistically significant differences were observed in individual matrices those differences were acceptable based upon the intended application of the method. Thus, the Agency believes that the SimPlate method is satisfactory as an additional method for determining the density of heterotrophic bacteria in the distribution system under the SWTR (§ 141.72(b)(3)).

The method description for SimPlate is available in the docket for this proposal or from IDEXX Laboratories, Inc., One IDEXX Drive, Westbrook, Maine 04092. Their telephone number is (800) 321-0207. Their website is www.idexx.com.

10. Hach Filter Trak

Hach Filter Trak (Method 10133) “Determination of Turbidity by Laser Nephelometry” is an additional industry developed method that employs a laser nephelometer to determine the turbidity of finished drinking waters. Method 10133 uses the Hach FilterTrak 660 nephelometer, which functions like a standard nephelometer but has the sensitivity of a particle counter. The method can be used both in a laboratory and on-line fashion.

Turbidity is determined by measuring the scatter of a laser beam onto a photomultiplier detector whose response spectrum significantly overlaps the spectra of the incident light source. Response is compared to the response of Hach Stablcal formazin standards to quantify sample turbidity. Method 10133's FilterTrak 660 system is designed to reduce background light scatter that can artificially raise turbidity measurements when using currently approved methods. Method 10133, by employing the FilterTrak 660, provides increased sensitivity to particle “events” (changes in particle concentration). Detection of particle “events” is critical to assessing performance of the filtration systems, which in turn is critical to protecting drinking water quality.

Method performance, laboratory and on-line, was characterized using a three laboratory validation study. The method demonstrated good correlation to approved methods and reduced interference from background light scatter. Also, Method 10133 provides quality control requirements to ensure proper operator use. USEPA believes that Method 10133 is a satisfactory additional method for the measurement of turbidity.

Method 10133 is available in the docket for this proposal or from Hach Co., P.O. Box 389, Loveland, Colorado, 80539-0389. Phone: 800-227-4224.

11. MI Agar Medium for Total Coliforms and E. coli.

USEPA approved 4-methylumbelliferyl-beta-D-galactopyranoside-indoxyl-beta-D-glucuronide (MI) agar medium as an alternative membrane filter medium for the detection of total coliforms and E. coli under the Total Coliform Rule and for enumerating total coliforms under the Surface Water Treatment Rule. (64 FR 67450, December 1, 1999) This approval is reflected in § 141.21(f)(3) and § 141.21(f)(6)(v) and in § 141.74(a)(1). In granting approval, however, USEPA inadvertently did not clearly indicate that colony verification on MI agar was not required. The false-positive rate for MI agar was 4.9% for total coliforms and 4.3% for E. coli. Based on these data, USEPA believes that colony verification should not be required and proposes to amend the regulatory language in footnote 6 of the table at § 141.21(f)(3) and in § 141.74(a)(1) to clarify this point.

Finally, USEPA is proposing to correct a typographical error found in section § 141.21(f) by replacing the citation for the “Presence-Absence (P-A) Coliform Test” which currently reads “9221” with “9221D.” USEPA previously proposed for approval and requested comment on (52 FR 42224, November 3, 1987) Method 9221D. USEPA approved Method 9221D on June 29, 1989 (54 FR 27544). The “D” was inadvertently dropped by a drinking water method update rule published on December 1, 1999, 64 FR 67450.

IV. Cost of the Rule

Today's proposed amendment to the UCMR adds Method 1605 for analysis of Aeromonas, a UCMR (1999) List 2 contaminant. The monitoring requirements for Aeromonas were proposed in June 2000 and subject to public comment and review. Following consideration of public comment, the requirements were promulgated in the January 11, 2001 UCMR. As specified in that rule, 180 small systems and 120 large systems were randomly selected to conduct Aeromonas monitoring. These systems were selected from the list of systems previously selected to conduct UCMR Assessment Monitoring.

USEPA has estimated system and Agency costs associated with Aeromonas monitoring and analysis, based on the burden associated with collecting samples and the analytical costs for Method 1605. There are no costs that will be incurred by States as a result of today's action. State costs attributed to UCMR during this first implementation cycle of 2001-2005 were covered within the UCMR (1999) cost estimations (64 FR 50556, September 17, 1999), and are accounted for in the UCMR discussion within the current ICR (OMB No. 2040-0204—Titled: “Disinfectants/Disinfection Byproducts, Chemical, and Radionuclides Information Collection Request”).

The collection of Aeromonas will necessitate some minimal additional labor burden for participating systems to collect samples. In many cases, the Aeromonas samples can be collected at the same time and place as other required distribution system sampling (such as that for the Total Coliform Rule (TCR)). For coincident monitoring, USEPA assumes 0.25 hours per sampling period per system. For monitoring periods in which coincident sampling is not possible, USEPA assumes one hour of labor per system per period. And finally, for monitoring periods in which sampling can only be partially coincident with other monitoring (such as for systems that only have to collect only one TCR sample per month), USEPA assumes 0.75 hours of labor per system per period. In addition, large systems were assumed to incur a small amount of labor burden associated with review of monitoring results, as reported to USEPA's UCMR database by their analytical laboratories. Small system reporting is being handled through USEPA's contract laboratories.

In addition to labor costs, non-labor costs will be incurred by USEPA and by participating large PWSs. Non-labor costs from this rule are solely attributed to the laboratory fees that will be charged for analysis of Aeromonas and to shipping charges for sending the sample bottles to the appropriate laboratory. USEPA will cover these costs for small system testing; however, participating large systems will be responsible for these analytical and shipping expenses. USEPA estimates that the average laboratory fee for Method 1605 will be $25. The additional costs for this laboratory analysis are calculated as follows: the number of systems multiplied by three sampling points in the distribution systems, multiplied by the sampling frequency of six times throughout the year 2003, and then multiplied by the $25 cost of the analysis. This cost would apply to the 120 large systems and to USEPA for the cost analyses for the 180 small systems. USEPA will also pay for quality assurance sampling for 10 percent of the small system samples.

In addition, USEPA estimates that Aeromonas will be detected in 10 percent of samples. Each of these positive Aeromonas samples (i.e., estimated as 10 percent of all samples, including the quality assurance samples for small systems) would incur an additional $25 cost for confirmation tests at the genus level (such tests are part of Method 1605). This would be the total cost to large systems. For small systems, where Aeromonas has been found, USEPA will pay for further genotyping at an estimated additional $100 per sample. For the cost estimations presented, USEPA assumes it will pay for genotyping for the estimated 10 percent of positive small system samples.

Today's rule also proposes to approve USEPA Methods 515.4 and 531.2 to support monitoring already required under Phase II/V monitoring (§ 141.24), and proposes eight additional industry developed analytical methods. This part of today's proposed rule merely allows for the optional use of additional standardized methods, offering systems and their laboratories further operational flexibility. Thus, USEPA believes that there is no cost or burden to public water systems associated with the addition of these additional methods. These additional methods may even reduce costs for the testing and analysis of contaminants. However, these potential savings to systems are not estimated here, since use of these methods is voluntary. In addition, because State adoption of these additional analytical methods is voluntary, no costs are estimated for States related to the additional analytical methods that are included in today's proposed rule. Moreover, States that do adopt additional methods often adopt such Federal regulation by reference, or may incorporate these voluntary options when the next set of required regulatory revisions are being incorporated.

The details of USEPA's cost assumptions and estimates regarding implementation of the Aeromonas Rule can be found in the proposed Information Collection Request (ICR) (ICR number 2040-0204). This ICR presents estimated cost and burden for the 2001-2005 period. Copies of the proposed ICR may be obtained from Susan Auby by mail at: Collection Strategies Division; U.S. Environmental Protection Agency (2822); 1200 Pennsylvania Avenue, NW., Washington, DC 20460, by e-mail at: auby.susan@epa.gov, or by calling: (202) 260-4901. A copy may also be downloaded from the Internet at: http://www.epa.gov/icr.

In preparing these cost estimates, USEPA relied on standard assumptions and data sources used in the preparation of other drinking water program ICRs. These include the public water system inventory and labor rates. USEPA expects that States will incur no additional labor or non-labor costs associated with the Screening Survey component of the UCMR.

USEPA estimates that the total cost for one year of Screening Survey 2 monitoring for Aeromonas (in 2003) is approximately $247,320. These total estimated costs are incurred as follows:

Over the five year UCMR implementation period of 2001-2005, the estimated average annual cost for each of the 120 large systems conducting Aeromonas monitoring is $12 (0.5 hours) per year for labor costs, and $118 for non-labor costs associated with testing and shipping. For the 180 small systems participating in Aeromonas monitoring in 2003, the average annual cost per system over that same period is $20.30 (0.84 hours) per year for labor costs (USEPA pays for all non-labor costs for small systems).

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 Office of Management and Budget (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 proposed 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 USEPA 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 proposed rule is not subject to Executive Order 13045 because it is not “economically significant” as defined under Executive Order 12866. Further, this proposed rule does not concern an environmental health or safety risk that USEPA has reason to believe may have a disproportionate effect on children.

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, USEPA 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 USEPA rule for which a written statement is needed, UMRA section 205 generally requires USEPA 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 USEPA 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 USEPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including Tribal 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 USEPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

USEPA has determined that today's proposed 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 UCMR implementation period of 2001-2005), for State, local, and Tribal governments and the private sector, are estimated to be $49,500, of which USEPA will pay $30,200, or approximately 61 percent. State drinking water programs are assumed to incur no additional costs associated with the Aeromonas Screening Survey component of the UCMR. No costs are estimated/incurred for the other methods included in this proposed rule since they represent additional methods that public water systems may elect to use but that are not required. Thus, today's proposed rule is not subject to the requirements of UMRA sections 202 and 205.

USEPA has determined that this proposed rule contains no regulatory requirements that might significantly or uniquely affect small governments because USEPA will pay for the reasonable costs of sample testing for the small PWSs required to sample and test for Aeromonas under this proposed rule, including those owned and operated by small governments. The only costs that small systems will incur are those attributed to collecting the Aeromonas samples and packing them for shipping to the laboratory (USEPA will also pay for shipping). These costs are minimal. They are not significant or unique. Again, no costs are estimated/incurred for the other methods. Thus, today's rule is not subject to the requirements of UMRA section 203.

D. Paperwork Reduction Act

The information collection requirements in this proposed rule have been submitted for approval to the OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. USEPA prepared an Information Collection Request (ICR) document (ICR No. 1896.03). A copy may be obtained from Susan Auby by mail at Collection Strategies Division; U.S. Environmental Protection Agency (2822); 1200 Pennsylvania Avenue, NW., Washington, DC 20460; by e-mail at: auby.susan@epa.gov; or by calling (202) 260-2740. A copy may also be downloaded from the internet at: http://www.epa.gov/icr.

The information to be collected under today's proposed 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 rate of occurrence of Aeromonas 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. The cost estimates described below for Aeromonas monitoring are attributed to laboratory fees, shipping costs, and some minimal labor burden for reading of requirements and for collecting samples. For large systems, labor burden estimates also consider activities related to reporting of results to USEPA's UCMR database.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and use technology and systems for the purposes of collecting, validating and verifying information, processing and maintaining 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.

Average annual non-labor costs during the five year ICR period (2001-2005) are estimated to be: $197 for each large system. USEPA will incur no additional labor costs for implementation of today's proposed rule. The Agency's annual non-labor costs for the ICR period are estimated to be $50,300. These non-labor costs are solely attributed to the cost of sample testing and sample kit shipping for the 180 small systems. A detailed discussion of these costs is presented in section IV.

Today's rule also proposes to approve USEPA Methods 515.4 and 531.2 to support monitoring already required under Phase II/V monitoring (§ 141.24), and proposes eight additional industry developed analytical methods. This part of today's proposed rule merely allows for the use of additional standardized methods, offering systems and their laboratories further operational flexibility. Thus, USEPA believes that there is no cost or burden to public water systems associated with the addition of these additional methods. In addition, because State adoption of analytical methods is voluntary, no costs are estimated for States related to the additional analytical methods that are included in today's proposed rule.

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 USEPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

Comments are requested on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques. Send comments on the proposed ICR to the Director, Collection Strategies Division; U.S. Environmental Protection Agency (2822); 1200 Pennsylvania Ave., NW., Washington, DC 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th St., NW., Washington, DC 20503, marked “Attention: Desk Officer for USEPA.” Include the ICR number (OMB No. 2040-0204) in any correspondence. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after March 7, 2002, a comment to OMB is best assured of having its full effect if OMB receives it by April 8, 2002. The final rule will respond to any OMB or public comments on the information collection requirements contained in this proposal.

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 proposed rule on small entities, USEPA considered small entities to be systems serving 10,000. This is the cut-off level specified by Congress in the 1996 Amendments to the Safe Drinking Water Act for small system flexibility provisions. In accordance with the RFA requirements, USEPA proposed using this alternative definition in the Federal Register (63 FR 7620, February 13, 1998), requested public comment, consulted with SBA, and expressed its intention to use the alternative definition for all future drinking water regulations in the Consumer Confidence Reports regulation, (63 FR 44511, August 19, 1998). As stated in that final rule, the alternative definition would be applied to this regulation as well.

After considering the economic impacts of today's proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities.

As for the UCMR, published on September 17, 1999, USEPA 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, USEPA used the “revenue test,” which compares a system's annual costs attributed to the rule with the system's annual revenues. USEPA used a “sales test” for privately owned systems, which involves the analogous comparison of UCMR-related costs to a privately owned system's sales. Because USEPA does not know the ownership types of the systems selected for Aeromonas monitoring, the Agency 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 (as estimated by USEPA's 1995 Community Water System Survey, http://www.epa.gov/safewater/cwssvr.html). The estimated distribution of the sample for today's proposed rule, categorized by ownership type, source water, and system size, is presented in the following table.

The basis for the UCMR RFA certification for today's proposed rule, which approves Method 1605 for the analysis of Aeromonas, was determined by evaluating average annual costs as a percentage of system revenues/sales. In the worst-case-scenario, the smallest system size category (i.e., 500 and under) is estimated to have revenues/sales of approximately $16,000 per year. The annual cost related to Aeromonas monitoring for these 55 systems represents less than 0.2 percent of their annual revenue/sales. The impact for larger systems will be even less significant. USEPA specifically structured the rule to avoid significantly affecting small entities by assuming all costs for laboratory analyses, shipping, and quality control for small entities. USEPA incurs the entirety of the non-labor costs associated with Aeromonas monitoring, or 89 percent of all costs. Small systems only incur labor costs associated with the collection of Aeromonas samples, and for reading about their sampling requirements, with an average annual labor cost per system over the 5 years of UCMR implementation of $20.30. USEPA continues to be interested in the potential impacts this proposal has on small entities and welcomes comments on issues related to such impacts.

F. National Technology Transfer and Advancement Act

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note) directs USEPA 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 USEPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

The proposed rulemaking involves technical standards. Therefore, the Agency conducted a search to identify potentially applicable voluntary consensus standards. USEPA identified no voluntary consensus standards for Aeromonas. Therefore, USEPA proposes to use USEPA Method 1605.

Concerning the approval of USEPA Method 515.4, while the Agency identified two new methods (ASTM D5317-98, and SM 6640 B) for the acid herbicides as being potentially applicable, we do not propose to include them in this rulemaking. USEPA decided not to approve SM 6640 B. The use of this voluntary consensus standard would have been impractical because of significant shortcomings in the sample preparation and quality control sections of the method instructions. USEPA previously approved ASTM Method D5317-93 for acid herbicides. ASTM D5317-98 is an updated version of ASTM D5317-93 with no changes in the basic procedure and with limited changes to “Table 4 Acceptance Criteria for Initial Demonstration of Proficiency” and the addition of a table of acceptance criteria for quality control samples. While these tables are slightly different than those in ASTM D5317-93, they still permit acceptance windows for the initial demonstration of proficiency for laboratory fortified blank samples that are as large as 0% to 223% recovery for picloram, with tighter criteria for other regulated contaminants. When ASTM D5317-93 was originally proposed, a set of fixed acceptance limits of 70% to 130% recovery was also proposed. Due to adverse public comments concerning the ability of laboratories to meet this criteria due to low recovery expectations for picloram (and other analytes not currently regulated), this criteria was withdrawn. USEPA is currently considering alternate procedures for determining useful acceptance criteria for these methods, however, a discussion and proposal of those procedures is beyond the scope of this regulation. Therefore, USEPA is proposing to add approval only for USEPA Method 515.4 for the acid herbicides at this time.

Concerning the approval of USEPA Method 531.2, while the Agency identified two new methods (Standard Method 6610, 20th Edition, and Standard Method 6610, 20th Supplemental Edition) for the carbamates as being potentially applicable, we do not propose to use them in this rulemaking. Standard Method 6610, 20th Edition has previously been proposed for compliance monitoring in (66 FR 3466, January 16, 2001). Since it is currently in the rulemaking process it is not included in this regulation. USEPA has concerns about the Standard Method 6610, 20th Supplemental Edition. This version of Method 6610 permits the use of a strong acid, hydrochloric acid (HCL), as a preservative. The preservatives in all of the other approved USEPA and Standard Methods procedures for these analytes are weak acids that adjust the pH to a specific value based upon the pKa of the preservative. The use of HCL would require accurate determinations of the pH of the sample in the field and could be subject to considerable error and possible changes in pH upon storage. Although not observed for oxamyl or carbofuran, structurally similar pesticides will degrade over time when kept at pH 3. Therefore, USEPA is concerned about the use of a strong acid such as HCL when positive control of the pH is critical. Therefore, USEPA is proposing to add approval only for USEPA Method 531.2 for determining oxamyl and carbofuran, at this time.

The eight analytical methods developed by industry being proposed in this regulation are additional analytic methods for use in drinking water compliance monitoring proposed to USEPA by industry. These industry methods will supplement existing approved methods, some of which are voluntary consensus standards.

USEPA welcomes comments on this aspect of the proposed rulemaking and specifically invites the public to identify potentially applicable voluntary consensus standards and to explain why such standards should be used in this regulation.

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. This proposal adds new analytic methods to Part 141. It does not withdraw any currently approved methods nor does it add nor alter any current monitoring requirement. The purpose of this proposal is to provide additional analytical methods for drinking water utilities to use to meet the currently existing monitoring requirements. USEPA has determined that there are no environmental justice issues in this rulemaking.

H. Executive Order 13132—Federalism

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires USEPA 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.”

This proposed 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. The objective of this proposed rule is to specify approved analytical methods, thereby allowing Aeromonas to be included in the UCMR Screening Survey program, and to add USEPA Methods 515.4 and 531.2 and eight additional industry developed methods that public water systems may use to conduct analyses previously required. The cost to State and local governments is minimal, and the rule does not preempt State law. Thus, Executive Order 13132 does not apply to this rule.

In the spirit of Executive Order 13132, and consistent with USEPA policy to promote communications between USEPA and State and local governments, USEPA specifically solicits comment on this proposed rule from State and local officials.

I. Executive Order 13175—Consultation and Coordination With Indian Tribal Governments

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 6, 2000), requires USEPA to develop an accountable process to ensure “meaningful and timely input by Tribal officials in the development of regulatory policies that have Tribal implications.” “Policies that have Tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.”

This proposed rule does not have Tribal implications. It will not have substantial direct effects on Tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. The objective of this proposed rule is to specify approved analytical methods, thereby allowing Aeromonas to be included in the UCMR Screening Survey program and to add USEPA Methods 515.4, 531.2 and eight additional industry developed methods that public water systems may use to conduct analyses previously required. Only one small Indian Tribal system was selected for Aeromonas monitoring. Since this utility will be receiving sampling assistance from the State of Montana and the USEPA will pay for all shipping and analysis costs, the cost to the Tribal government will be minimal. The rule does not preempt Tribal law. Thus, Executive Order 13175 does not apply to this rule.

In the spirit of Executive Order 13175, and consistent with USEPA policy to promote communications between USEPA and Tribal governments USEPA specifically solicits additional comment on this proposed rule from Tribal officials.

J. Plain Language Directive

Executive Order 12866 requires each agency to write all rules in plain language. USEPA invites public comment on how to make this proposed rule easier to understand. Comments may address the following questions and other factors, as well:

A. Has USEPA organized the material to suit your needs?

B. Are the requirements in the rule clearly stated?

C. Does the rule contain technical wording or jargon that is not clear?

D. Would a different format (grouping or order of sections, use of headings, paragraphing) make the rule easier to understand?

E. Would more (but shorter) sections be better?

F. Could USEPA improve clarity by using additional tables, lists or diagrams?

G. What else could USEPA do to make the rule easier to understand?

K. Executive Order 13211—Energy Effects

This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

VI. References

Abbott, S.L., W.K.W. Cheung, S. Kroske-Bystrom, T. Malekzadeh, and J.M. Janda. 1992. Identification of Aeromonas strains to the genospecies level in the clinical laboratory. Journal of Clinical Microbiology. 30:1262-1266.

Altwegg, M., A.G. Steigerwalt, R. Altwegg-Bissig, J. Lüthy-Hottenstein, and D.J. Brenner. 1990. Biochemical Identification of Aeromonas Genospecies Isolated from Humans. Journal of Clinical Microbiology. 28(2):258-264.

Borrell, N., M.J. Figueras, and J. Guarro. 1998. Phenotypic Identification of Aeromonas Genomospecies from Clinical and Environmental Sources. Canadian Journal of Microbiology. 44:103-108.

CPI International, validation report for Colitag for coliforms and E. Coli, February 17, 1999.

Demarta, A., M.Tonolla, A.P. Caminada, N. Ruggeri, and R. Peduzzi. 1999. Signature region within the 16S rDNA sequence of Aeromonas popoffii. FEMS Microbiol. Lett. 172 (2): 239-246.

Hach Company, “Hach Method 10133 Determination of Turbidity By Laser Nephelometry Validation Study Report” (Undated).

Havelaar, A.H., M. During, and J.F.M. Versteegh. 1987. Ampicillin-Dextrin Agar Medium for the Enumeration of Aeromonas Species in Water by Membrane Filtration. Journal of Applied Microbiology. 62:279-287.

IDEXX Laboratories Inc., “USEPA Pour Plate vs SimPlate for HPC Study” October 19-23, 1998.

Janda, J.M. 1991. Recent Advances in the Study of the Taxonomy, Pathogenicity, and Infectious Syndromes Associated with the Genus Aeromonas. Clinical Microbiology Reviews. 4(4):397-410.

Kelada, Nabih, validation report for the “Kelada Automated Test Methods for Total Cyanide, and Thiocyanate” (Undated).

Lachat Instruments Division, “Validation Study Report for Tier 3 for Modification of Part 136 Reference Method 335.2 and Part 141 Reference Method 335.4”, May 11, 1999

MERCK Corporation, Readycult and Chromocult Coliform Agar Validation Report, March 20, 2000.

Morgan, D., P.C. Johnson, H.L. DuPont, T.K. Satterwhite, and L.V. Wood. 1985. Lack of correlation between known virulence properties of Aeromonas hydrophila and enteropathogenicity for humans. Infection and Immunity. 50:62-65.

Novartis Crop Protection, Inc., “Validation Study of an Atrazine immunoassay for Drinking Water Monitoring in Compliance with the Safe Drinking Water Act”, May 26, 1999.

Palumbo, S., G.N. Stelma Jr., and C. Abeyta. 2000. The Aeromonas hydrophila group. In: The Microbiological Safety and Quality of Food, B.M. Lund, T.C. Baird-Parker, and G.W. Gould (eds.), Aspen Publishers, Inc. Gaithersburg, MD.

USEPA. 2001. Results of the Interlaboratory Validation of Method 1605: Aeromonas in Finished Water, December 2001, EPA # 821-R-01-038.

List of Subjects in 40 CFR Part 141

• Environmental protection
• Chemicals
• Indians-lands
• Intergovernmental relations
• Radiation protection
• Reporting and recordkeeping requirements
• Water supply

For the reasons set out in the preamble, title 40, chapter I of the Code of Federal Regulations is proposed to be 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, and 300j-11.

2. Section 141.21 is amended:

a. By revising the Table in paragraph (f)(3),

b. By adding paragraphs (f)(6) (viii) through (x).

The revision and additions read as follows:

(k) * * *

(1) * * *

4. Section 141.24 is amended by revising paragraph (e)(1) and by revising the table in paragraph (e)(1) to read as follows:

5. Section 141.40 is amended in paragraph (a)(3), table 1, by revising the second List 2 table including the title, and by revising footnotes f and h, to read as follows:

(a) * * *

(3) * * *

6. Section 141.74 is amended by revising the table in paragraph (a)(1) and adding footnotes 11 and 12 to read as follows:

(a) * * *

(1) * * *