hapter I Introduction Public water systems serving at least 25 persons or having at least 15 service connections must comply with the Safe Drinking Water Act(SDWA)and the requirements of the National Primary Drinking Water Regulations(NPDw CFR 141). Section 1401(1)D)of the Act defines a National Primary Drinking Water Regulation to include"criteria and procedures.. [for] quality control and testing procedures to insure compliance.. " EPA regulations require community water systems to conduct monitoring for compliance with the drinking water standards. In addition, regulations provide that analyses must be conducted by laboratories certified by ePa or the States. The regulations also established requirements for laboratory certification The regulations governing primacy at 40 CFR 142.10(b)(4)require, as a condition of primary enforcement responsibility (primacy), that a state have laboratory facilities available (the Principal State Laboratory) certified by the regional administrator. In addition, the regulations governing certification(40 CFR 141.28)require that all testing for compliance calcium, conductivity, orthophosphate, TOC, SUVA, daily chlorite, and silica may be performed by anyone acceptable to the State. This manual is intended to assist EPA in implementing 40 CFR 142. 10()(4)by specifying criteria and procedures EPA uses in evaluating principal State laboratories for certification. States with primacy may also choose to use equivalent criteria and procedures similar to those in this manual for their own certification programs To obtain and maintain primacy, a State must comply with 40 CFR 142.10, which includes the following provisions: The establishment and maintenance of a State program for the certification of laboratories conducting analytical measurements of drinking water contaminants pursuant to the requirements of the State primary drinking water regulations including the designation by the State of a laboratory officer, or officers, certified by the Administrator, as the official(s) responsible for the State's certification program. The requirements of this paragraph may be waived by the administrator for any State where all analytical measurements required by the State's primary drinking water regulations are conducted at laboratories operated by the state and certified by the Agency (40 CFR 142.10(b)(3)(i) Assurance of the availability to the state of laboratory facilities certified by the Administrator and apable of performing analytical measurements of all contaminants specified in the State primary drinking water regulations ..(40 CFR 142.10(b )(4) NOTE: Reference to the administrator of ePa also refers to his or her designee The requirement for a laboratory certification program extends to EPA Regional laboratories, Tribal Nation laboratories, principal State laboratories in primacy States, and laboratories that perform analyses under the Safe Drinking Water Act in States without primacy. If all required analyses are not performed in principal State laboratories, primacy States must have a certification program for certifying other drinking water laboratories (40 CFR 142.10(b)(3)(D)) EPAs Technical Support Center (TSC)in Cincinnati, Ohio, with the assistance of the National Exposure Research Laboratory in Cincinnati, Ohio (NERL-Ci), is responsible for determining the certification status for EPAs Regional laboratories in microbiology, chemistry, and radiochemistry. Regional certification officers are responsible for the certification of the principal State laboratory in each primacy State, and are also responsible for certifying all tribal Nation laboratories and laboratories in non-primacy States. Primacy States with certification programs are responsible for certifying the other drinking water laboratories in their State, (i.e, laboratories other than the principal State Laboratory) Regional Laboratories must successfully analyze a set of proficiency testing samples(PTs) at least annually for all regulated contaminants for which they wish to be certified, by each method for which they wish to be certified (40 CFR
I-1 Chapter I Introduction Public water systems serving at least 25 persons or having at least 15 service connections must comply with the Safe Drinking Water Act (SDWA) and the requirements of the National Primary Drinking Water Regulations (NPDWR) (40 CFR 141). Section 1401(1)(D) of the Act defines a National Primary Drinking Water Regulation to include "criteria and procedures . . . [for] quality control and testing procedures to insure compliance . . . " EPA regulations require community water systems to conduct monitoring for compliance with the drinking water standards. In addition, regulations provide that analyses must be conducted by laboratories certified by EPA or the States. The regulations also established requirements for laboratory certification.. The regulations governing primacy at 40 CFR 142.10(b)(4) require, as a condition of primary enforcement responsibility (primacy), that a state have laboratory facilities available (the Principal State Laboratory) certified by the regional administrator. In addition, the regulations governing certification (40 CFR 141.28) require that all testing for compliance purposes be performed by certified laboratories except that turbidity, free chlorine residual, temperature, pH, alkalinity, calcium, conductivity, orthophosphate, TOC, SUVA, daily chlorite, and silica may be performed by anyone acceptable to the State. This manual is intended to assist EPA in implementing 40 CFR 142.10(b)(4) by specifying criteria and procedures EPA uses in evaluating principal State laboratories for certification. States with primacy may also choose to use equivalent criteria and procedures similar to those in this manual for their own certification programs. To obtain and maintain primacy, a State must comply with 40 CFR 142.10, which includes the following provisions: The establishment and maintenance of a State program for the certification of laboratories conducting analytical measurements of drinking water contaminants pursuant to the requirements of the State primary drinking water regulations including the designation by the State of a laboratory officer, or officers, certified by the Administrator, as the official(s) responsible for the State's certification program. The requirements of this paragraph may be waived by the Administrator for any State where all analytical measurements required by the State's primary drinking water regulations are conducted at laboratories operated by the State and certified by the Agency. (40 CFR 142.10(b)(3)(i)) Assurance of the availability to the State of laboratory facilities certified by the Administrator and capable of performing analytical measurements of all contaminants specified in the State primary drinking water regulations . . . (40 CFR 142.10(b)(4)). NOTE: Reference to the Administrator of EPA also refers to his or her designee. The requirement for a laboratory certification program extends to EPA Regional laboratories, Tribal Nation laboratories, principal State laboratories in primacy States, and laboratories that perform analyses under the Safe Drinking Water Act in States without primacy. If all required analyses are not performed in principal State laboratories, primacy States must have a certification program for certifying other drinking water laboratories (40 CFR 142.10(b)(3)(i)). EPA's Technical Support Center (TSC) in Cincinnati, Ohio, with the assistance of the National Exposure Research Laboratory in Cincinnati, Ohio (NERL-Ci), is responsible for determining the certification status for EPA’s Regional laboratories in microbiology, chemistry, and radiochemistry. Regional certification officers are responsible for the certification of the principal State laboratory in each primacy State, and are also responsible for certifying all Tribal Nation laboratories and laboratories in non-primacy States. Primacy States with certification programs are responsible for certifying the other drinking water laboratories in their State, (i.e., laboratories other than the principal State Laboratory). Regional Laboratories must successfully analyze a set of proficiency testing samples (PTs) at least annually for all regulated contaminants for which they wish to be certified, by each method for which they wish to be certified (40 CFR
141.23 and 141. 24), and pass an on-site evaluation at least every three years. An on-site evaluation determines conformance with the criteria specified in this manual. Principal State laboratories must (40 CFR 141.23 and 141. 24) successfully analyze a complete set of proficiency testing(PT) samples from a source acceptable to the region at least annually for the contaminants and methods included in the regulations which the State has adopted, and pass an on-site evaluation every three years. EPA auditors use the criteria in this manual for the on-site audits of the regional and principal State laboratories Chapter ll describes the responsibilities of each of the parties involved in the certification program. Chapter Ill describes how the program operates. Chapters IV, V, and VI cover the technical criteria to be used during the on-site evaluation of a laboratory for chemistry, microbiology, and radiochemistry, respectively. Optional audit forms are also included in Chapters IV, V, and VI. The appendices include the following: a recommended protocol and format for conducting on-site laboratory evaluations which may be used by the laboratory auditors; frequently used abbreviations and definitions; EPA's policy on third-party auditors: EPAs policy on National Environmental Laboratory Accreditation Program(NELAP)accreditation as an alternate for drinking water certification; a list of contaminants a principal State laboratory must(primacy citation 142.10(b)(4)have the capability to analyze, analytical methods for microbiology analyses; and recommended chain-of-custody procedures to be used when necessary I-2
I-2 141.23 and 141.24), and pass an on-site evaluation at least every three years. An on-site evaluation determines conformance with the criteria specified in this manual. Principal State laboratories must (40 CFR 141.23 and 141.24) successfully analyze a complete set of proficiency testing (PT) samples from a source acceptable to the Region at least annually for the contaminants and methods included in the regulations which the State has adopted, and pass an on-site evaluation every three years. EPA auditors use the criteria in this manual for the on-site audits of the Regional and principal State laboratories. Chapter II describes the responsibilities of each of the parties involved in the certification program. Chapter III describes how the program operates. Chapters IV, V, and VI cover the technical criteria to be used during the on-site evaluation of a laboratory for chemistry, microbiology, and radiochemistry, respectively. Optional audit forms are also included in Chapters IV, V, and VI. The appendices include the following: a recommended protocol and format for conducting on-site laboratory evaluations which may be used by the laboratory auditors; frequently used abbreviations and definitions; EPA's policy on third-party auditors; EPA’s policy on National Environmental Laboratory Accreditation Program (NELAP) accreditation as an alternate for drinking water certification; a list of contaminants a principal State laboratory must (primacy citation 142.10(b)(4)) have the capability to analyze, analytical methods for microbiology analyses; and recommended chain-of-custody procedures to be used when necessary
Chapter l Responsibilities The success of the laboratory certification program depends upon cooperation among the organizations responsible for its implementation. Within the Agency, responsibilities for laboratory certification are shared by the office of Ground Water and Drinking Water(OGWDW), the Office of Research and Development (ORD), and the regional offices. Office of Ground Water and Drinking Water (oG wDw)and Office of Research and Development (ORD) OGWDw, with assistance from ORD, has the responsibility for developing and implementing the national certification program for laboratories that analyze drinking water samples and for implementing the Safe Drinking Water Act. These responsibilities include the follow Propose and promulgate regulations; Assess national laboratory capacity and capability Review the EPa regional certification programs annually and evaluate the resources and personnel available in each EPA Region to carry out the certification program Develop guidance and respond to questions and comments Develop technical and administrative certification criteria to support future regulations; Revise this manual when necessary Conduct triennial on-site audits of each Regional laboratory for chemistry, microbiology, and radiochemistry Maintain a database of laboratory ID Codes Develop and participate in training courses to support the certification program; Provide technical assistance to epa and the states: Develop and evaluate methods for the analysis of drinking water contaminants EPA Regions The Regions oversee the certification programs in the States and Tribal Nations. The regions'responsibilities are to: Determine the certification status for the principal State/Tribal laboratory system in each primacy State/Tribe Perform an annual review of State/Tribal certification programs and proficiency testing results and monitor the adequacy of State/Tribal programs for certifying laboratories, as described in Chapter Ill; Sponsor annual meetings for the state Certification Officers(COs); Provide technical assistance to the States' EPA- certified drinking water laboratories, as needed; Manage the certification program for drinking water laboratories in non-primacy States using the criteria in this Manage the certification program for drinking water laboratories on Tribal Nation lands using the criteria in this manual This last duty may be performed by the State, but the region retains responsibility for the on-site evaluation of the designated Tribal Nation principal laboratory. Drinking water laboratories may be evaluated by the region, or under a Region-approved program carried out by a designated State program. In either case, this manual is the basis for the on-site audits, conducted by EPA, of principal State laboratories, laboratories on Tribal Nation lands, and drinking water laboratories in non-primacy States The Regional laboratory should maintain certification for as many regulated contaminants as its resources permit. This enhances both EPA's technical assistance capabilities and credibility with those it certifies. It also ensures the laboratory capability to analyze samples for possible enforcement actions and for States which do not have primacy. Reciprocal agreements with other regions to share scarce resources are recommended I-I
II-1 Chapter II Responsibilities The success of the laboratory certification program depends upon cooperation among the organizations responsible for its implementation. Within the Agency, responsibilities for laboratory certification are shared by the Office of Ground Water and Drinking Water (OGWDW), the Office of Research and Development (ORD), and the Regional Offices. Office of Ground Water and Drinking Water (OGWDW) and Office of Research and Development (ORD) OGWDW, with assistance from ORD, has the responsibility for developing and implementing the national certification program for laboratories that analyze drinking water samples and for implementing the Safe Drinking Water Act. These responsibilities include the following: • Propose and promulgate regulations; • Assess national laboratory capacity and capability; • Review the EPA Regional certification programs annually and evaluate the resources and personnel available in each EPA Region to carry out the certification program; • Develop guidance and respond to questions and comments; • Develop technical and administrative certification criteria to support future regulations; • Revise this manual when necessary; • Conduct triennial on-site audits of each Regional laboratory for chemistry, microbiology, and radiochemistry • Maintain a database of laboratory ID Codes • Develop and participate in training courses to support the certification program; • Provide technical assistance to EPA and the States; • Develop and evaluate methods for the analysis of drinking water contaminants. EPA Regions The Regions oversee the certification programs in the States and Tribal Nations. The Regions' responsibilities are to: • Determine the certification status for the principal State/Tribal laboratory system in each primacy State/Tribe; • Perform an annual review of State/Tribal certification programs and proficiency testing results and monitor the adequacy of State/Tribal programs for certifying laboratories, as described in Chapter III; • Sponsor annual meetings for the state Certification Officers (COs); • Provide technical assistance to the States' EPA-certified drinking water laboratories, as needed; • Manage the certification program for drinking water laboratories in non-primacy States using the criteria in this manual. • Manage the certification program for drinking water laboratories on Tribal Nation lands using the criteria in this manual. This last duty may be performed by the State, but the Region retains responsibility for the on-site evaluation of the designated Tribal Nation principal laboratory. Drinking water laboratories may be evaluated by the Region, or under a Region-approved program carried out by a designated State program. In either case, this manual is the basis for the on-site audits, conducted by EPA, of principal State laboratories, laboratories on Tribal Nation lands, and drinking water laboratories in non-primacy States. The Regional laboratory should maintain certification for as many regulated contaminants as its resources permit. This enhances both EPA's technical assistance capabilities and credibility with those it certifies. It also ensures the laboratory capability to analyze samples for possible enforcement actions and for States which do not have primacy. Reciprocal agreements with other regions to share scarce resources are recommended
Primacy States Primacy States, in which all drinking water compliance samples are not analyzed at State operated laboratories, are required to establish and maintain a State program for the certification of laboratories conducting analyses of drinking ater compliance samples [see 40 CFR 142.10()( 3()]. EPA encourages the States to base certification of drinking water laboratories either upon criteria contained in this manual or upon state-developed equivalents that are at least as stringent as this manual. Primacy States must establish and maintain a state program for the certification of laboratories conducting analytical measurements of drinking water contaminants pursuant to the requirements of the State primary drinking water regulations. The States must designate a "laboratory officer or officers, certified by the administrator or designee as the official(s) responsible for the certification program. "(40 CFR $142.10(a)()(i)) States are responsible for the certification of the public and private laboratories in their State. This includes auditing the laboratories and reviewing the Pt data. States should also provide technical assistance to laboratories. They may also hoose to certify laboratories outside their State either by an on-site evaluation or reciprocity I-2
II-2 Primacy States Primacy States, in which all drinking water compliance samples are not analyzed at State operated laboratories, are required to establish and maintain a State program for the certification of laboratories conducting analyses of drinking water compliance samples [see 40 CFR 142.10(b)(3)(i)]. EPA encourages the States to base certification of drinking water laboratories either upon criteria contained in this manual or upon state-developed equivalents that are at least as stringent as this manual. Primacy States must establish and maintain a state program for the certification of laboratories conducting analytical measurements of drinking water contaminants pursuant to the requirements of the State primary drinking water regulations. The States must designate a “laboratory officer or officers, certified by the Administrator or designee as the official(s) responsible for the certification program.” (40 CFR §142.10 (a)(3)(i)) States are responsible for the certification of the public and private laboratories in their State. This includes auditing the laboratories and reviewing the PT data. States should also provide technical assistance to laboratories. They may also choose to certify laboratories outside their State either by an on-site evaluation or reciprocity
Chapter lll Implementation 1. Evaluation of Certification Programs OGWDW and the regions monitor the certification programs under their purview annually. These offices assess the adequacy of programs for certifying laboratories by evaluating each program,s scope, staffing, resources, policies procedures, and effectiveness. This should be done in person during an on-site audit when possible, and at least by means of a questionnaire in the other years. The adequacy of these essential program elements is evaluated by: Reviewing the program plan, responsibilities, organizational structure, staff(including educational background nd experience), scope and description of the certification process, downgrading criteria and processes, and use Requesting an annual program report that includes program highlights, training, continuing education efforts, number of on-site evaluations performed, listing of laboratories certified by discipline or contaminant, and any certification downgrading or upgrading actions along with reasons for those actions Observing the state certification officers on-site audits of drinking water laboratories Encouraging State and Regional laboratory auditors to observe on-site audits of their own and other laboratories Sponsoring annual meetings of certification officers to discuss program issues, policies, and problems. Key Legional, NERL, OGWDw, and State personnel should be invited to participate 2. Requirements for Certification of laboratories In order to be eligible to analyze compliance samples under the Safe Drinking Water Act, Regional and Principal State laboratories should meet the minimum criteria specified in this manual, which includes passing an on-site audit at least once every three years, and satisfactorily analyzing a set of PT samples annually The office of Ground Water and Drinking Water (oG WDW)will accept NeLaP accreditation as equivalent to Drinking Water certification, if all requirements of the drinking water program are met 3. Individual(s) Responsible for the Certification Program The Technical Support Center, with the assistance from NERL-Ci is responsible for certifying the regional laboratories; the Regions are responsible for certifying their States' principal laboratory systems and Tribal Nations'laboratories: and the states are responsible for certifying private, municipal, non-principal state, and governments laboratorie The certification program personnel in each Region should consist of a certification authority(s)(CA), the certification program manager, and a certification team comprised of certification officers(COs)and technical experts. Additional third party auditors and experts may be used. However, third parties has have no authority for certification decisions Third party auditing is discussed in Section 4.2 The Certification Authority(CA)is the person who has signature authority for all certification decisions. This is the Chief of the Technical Support Center and the Regional Administrator in the Regions. The Ra may delegate this authority to a lower level The Certification Program Manager(CPM) is the person responsible for managing the drinking water laboratory certification activities in the Region The Certification Officers(COs)are the regional and state personnel who have the responsibility of certifying laboratories under their purview. 40 CFR 142.10(b)(3)()requires Primacy States to designate a person certified by the Administrator as the official responsible for the State's certification program. This person would be the State certification I-I
III-1 Chapter III Implementation 1. Evaluation of Certification Programs OGWDW and the Regions monitor the certification programs under their purview annually. These offices assess the adequacy of programs for certifying laboratories by evaluating each program's scope, staffing, resources, policies, procedures, and effectiveness. This should be done in person during an on-site audit when possible, and at least by means of a questionnaire in the other years. The adequacy of these essential program elements is evaluated by: • Reviewing the program plan, responsibilities, organizational structure, staff (including educational background and experience), scope and description of the certification process, downgrading criteria and processes, and use of PT samples; • Requesting an annual program report that includes program highlights, training, continuing education efforts, number of on-site evaluations performed, listing of laboratories certified by discipline or contaminant, and any certification downgrading or upgrading actions along with reasons for those actions; • Observing the state certification officers on-site audits of drinking water laboratories; • Encouraging State and Regional laboratory auditorsto observe on-site audits of their own and other laboratories as on-the-job training; • Sponsoring annual meetings of certification officers to discuss program issues, policies, and problems. Key Regional, NERL, OGWDW, and State personnel should be invited to participate. 2. Requirements for Certification of Laboratories In order to be eligible to analyze compliance samples under the Safe Drinking Water Act, Regional and Principal State laboratories should meet the minimum criteria specified in this manual, which includes passing an on-site audit at least once every three years, and satisfactorily analyzing a set of PT samples annually. The Office of Ground Water and Drinking Water (OGWDW) will accept NELAP accreditation as equivalent to Drinking Water certification, if all requirements of the drinking water program are met. 3. Individual(s) Responsible for the Certification Program The Technical Support Center, with the assistance from NERL-Ci is responsible for certifying the regional laboratories; the Regions are responsible for certifying their States’ principal laboratory systems and Tribal Nations’ laboratories; and the States are responsible for certifying private, municipal, non-principal state, and governments laboratories. The certification program personnel in each Region should consist of a certification authority(s) (CA), the certification program manager, and a certification team comprised of certification officers (COs) and technical experts. Additional third party auditors and experts may be used. However, third parties has have no authority for certification decisions. Third party auditing is discussed in Section 4.2. The Certification Authority (CA) is the person who has signature authority for all certification decisions. This is the Chief of the Technical Support Center and the Regional Administrator in the Regions. The RA may delegate this authority to a lower level. The Certification Program Manager (CPM) is the person responsible for managing the drinking water laboratory certification activities in the Region. The Certification Officers (COs) are the regional and state personnel who have the responsibility of certifying laboratories under their purview. 40 CFR 142.10(b)(3)(i) requires Primacy States to designate a person certified by the Administrator as the official responsible for the State's certification program. This person would be the State certification authority