Florida Regulations 62-160.120: Definitions and Standards
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For purposes of this chapter:
(1) “”Alternative method”” is a field procedure or analytical laboratory method that is intended to be used in place of an existing Department-approved laboratory method or field procedure that is specified in a Department rule, permit, order, or contract, as further discussed in Rules 62-160.220 and 62-160.330, F.A.C.
(2) “”Audit”” is a systematic review of laboratory and field protocols to determine if proper procedures are being used and supporting documentation is present. An audit shall consist of an on-site assessment of sample collection, field sampling procedures, laboratory procedures and/or a review, assessment and/or validation of data associated with a Department program activity. If necessary, an audit shall include the submission of performance samples (for example, blind, split and/or performance check samples) to an organization for subsequent use in the evaluation of that organization’s technical performance associated with a specific Department project or program activity.
(3) “”Commercial Vendor”” is a retail or wholesale company whose business is to sell commodities to customers and who is not a part of the process that generates environmental data. These businesses do not include organizations that purchase commodities with the intent of providing the commodities as a service to clients.
(4) “”Common Carrier”” is a business or agency that is available to the general public for the transportation of goods over a definite route and according to a regular schedule.
(5) “”Data quality objectives”” are a set of qualitative and quantitative statements derived from a systematic planning process that clarify the purpose of the study, define the most appropriate type of information to collect, determine the most appropriate conditions from which to collect that information, and specify tolerable levels of potential decision errors.
(6) “”Data validation”” is an evaluation of the technical usability of the verified data with respect to the planned objectives or intention of a project.
(7) “”Data verification”” is a consistent, systematic process that determines whether the data have been collected in accordance with project specifications with respect to compliance, correctness, consistency and completeness as compared to a method standard or contract specification.
(8) “”Department”” is the Florida Department of Environmental Protection.
(9) “”Department-approved method”” is a field procedure or laboratory analytical method specified as acceptable for use in this chapter and in any other Department contract, order, permit or Title 62 rules.
(10) “”Department of Health (DOH) Environmental Laboratory Certification Program (ELCP)”” is the state of Florida’s environmental laboratory certification program, authorized by Florida Statutes § 381.00591, and recognized by the National Environmental Laboratory Accreditation Program (NELAP) Acceditation Council as an authority with responsibility and accountability for granting accreditation for specified fields of laboratory testing through Fl. Admin. Code Chapter 64E-1
(11) “”Electronic signature”” means an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record.
(12) “”Holding time”” is the storage time allowed between sample collection and sample preparation and/or analysis as specified by regulatory requirements or by the field sample collection protocol or laboratory method.
(13) “”Limited-use method”” is an alternative or modified field or laboratory procedure that is approved by the Department for the collection or testing of environmental samples by a single field sampling organization or analytical laboratory for purposes specified in the scope of the approval (e.g., for specified analytes, facility or site locations or types, or sample matrices, such as effluent, groundwater, drinking water, fresh or marine surface waters, soils, sediments, or chemical wastes). A limited-use method that is validated and approved by the Department for a field sampling organization or analytical laboratory may not be used by another field sampling organization or analytical laboratory. The criteria for the validation and approval of a limited-use method are further outlined in subparts FA 2100 and FA 2200 of DEP SOP FA 1000, which is incorporated by reference in subFl. Admin. Code R. 62-160.800(1)(a)1., and outlined in DEP-QA-001/01, which is incorporated by reference in subsection 62-160.800(5), F.A.C. Requirements for limited-use methods are further discussed in Rules 62-160.220 and 62-160.330, F.A.C., and must be met for Department approval.
(14) “”Matrix”” is the predominant material in which an analyte of interest is contained. For example, soil, groundwater and drinking water are three environmental matrices.
(15) “”Method-defined analyte”” is defined by the U.S. Environmental Protection Agency as an analyte whose result is totally dependent on how the measurement is made. Any changes or modifications in the preparation or determinative techniques of these methods have the potential of changing the result, and are not approved by the Department, as indicated in Fl. Admin. Code R. 62-160.330(2)(a) Examples are: Carbonaceous Biological Oxygen Demand, Oil and Grease, and Toxicity Characteristic Leaching Procedure (TCLP).
(16) “”Method detection limit (MDL)”” is an estimate of the minimum amount of a substance that an analytical process can reliably detect, the minimum measured concentration of a substance that can be reported with 99% confidence that the measured concentration is distinguishable from method blank results, or the minimum result that can be reliably discriminated from a blank with a predetermined confidence level (Limit of Detection [LOD] as defined in the 2016 TNI Standards, which are incorporated by reference in Fl. Admin. Code R. 62-160.800(3)(b)). The Department accepts any of the preceding definitions of the MDL. An MDL is analyte-specific and matrix-specific and is laboratory-dependent. The MDL for an analyte is determined from the preparation and analysis of a sample in a given matrix containing the analyte. MDLs shall be determined for each matrix/analytical technology/analyte combination reported by the laboratory, except for those tests where determination of the MDL is not appropriate for the analytical technique, such as biochemical oxygen demand, chlorophyll or microbiological tests. When required according to Department rules, MDLs shall be calculated following the procedure specified in those rules. If not specified in Department rules, MDLs may be determined and verified by any technically justifiable and scientifically sound method appropriate for the test. For the purposes of data usability evaluation, the DEP-defined MDL is equivalent to the Limit of Detection (LOD) as defined in the 2016 TNI Standards, which are incorporated by reference in Fl. Admin. Code R. 62-160.800(3)(b)
(17) “”Method modification”” is any change that alters the scope, applicability, specifications, steps, performance criteria, or any other requirements described in a published field procedure or laboratory analytical method, as further specified in subsections 62-160.220(3) and 62-160.330(3), F.A.C. The resultant method is defined by the Department as a “”modified method.””
(18) “”Field of Accreditation Matrix”” is defined in the Glossary of the 2003 NELAC Standards, which is incorporated by reference in Fl. Admin. Code R. 62-160.800(3)(a), and shall be used to determine matrices under which a laboratory must be certified by the DOH ELCP for reporting data to be used by the Department:
(a) Drinking Water: any aqueous sample that has been collected from a water source designated by the Department as a potable or potential potable water source.
(b) Non-potable Water: any aqueous sample excluded from the definition of drinking water matrix including surface water, groundwater, effluents, water treatment chemicals, or samples derived from synthetic precipitation leaching procedures (SPLP), toxicity characteristic leaching procedures (TCLP) or other extracts. To be considered as non-potable water, water treatment chemicals must be in an aqueous solution. If the laboratory receives the original environmental sample as a solid or chemical material for SPLP or TCLP extraction, the laboratory must be certified for the SPLP or TCLP extraction in the Solid and Chemical Material matrix. For the analytical tests to be performed on the SPLP or TCLP extract, the laboratory must be certified in the non-potable water matrix for at least one method for each analytical technology/analyte combination for each reported analyte.
(c) Solid and Chemical Materials: includes soils, sediments, sludges, products and by-products of an industrial process that results in a matrix not previously defined. For purposes of accreditation, biosolids are considered a solid, unless the sample matrix comprises liquid biosolids as defined in Fl. Admin. Code Chapter 62-640 All other sample matrices not previously defined and comprising ≤ 15% settleable solids are liquids, and may require laboratory certification for analysis using techniques for non-potable water or liquid chemical materials.
(d) Biological Tissue: any sample of a biological origin, such as fish, shellfish, macroinvertebrates, algae, or plant material.
(19) “”National Environmental Laboratory Accreditation Program (NELAP)”” is a program that implements standards that have been found to be acceptable to the NELAP Accreditation Council.
(20) “”NELAP accreditation”” is an accreditation status applied to a laboratory’s field(s) of testing upon satisfying all requirements for certification as provided in Fl. Admin. Code Chapter 64E-1
(21) “”Percent relative standard deviation (% RSD)”” is a calculated measure of precision from results of replicate sample analyses. It is calculated as specified in DEP-QA-001/01 (January 2017), which is incorporated by reference in Fl. Admin. Code R. 62-160.800
(22) “”Permit”” is any permit or license issued by the Department pursuant to its lawful authority, or by another government agency under delegation of authority from the Department.
(23) “”Practical quantitation limit (PQL)”” is the lowest level of measurement that can be reliably achieved during routine laboratory operating conditions within specified limits of precision and accuracy. The value of the PQL shall be greater that the MDL value except when analytical quality control problems necessitate raising the MDL value equal to or above the PQL value for a specific sample, or when determination of the MDL is not appropriate for an analytical technique, as indicated below. A laboratory may determine and verify the PQL by any technically justifiable d scientifically sound method appropriate for the test, unless otherwise required by Department rule, contract, order, or permit. For Departmental use, if a laboratory fails to report a PQL, the PQL shall be calculated as four times the MDL, except for those tests where determination of the MDL is not appropriate for the analytical technique (e.g., biochemical oxygen demand, chlorophyll or microbiological tests). In such cases, the Department shall use all available information about the technique to determine the PQL. For the purposes of data usability evaluation, the DEP-defined PQL is equivalent to the Limit of Quantitation (LOQ) as defined in the 2016 TNI Standards, which are incorporated by reference in Fl. Admin. Code R. 62-160.800(3)(b)
(24) “”Quality assurance”” is an integrated system of management activities involving planning, implementation, documentation, assessment, reporting and quality improvement to ensure that a process, product or service meets defined standards of quality.
(25) “”Quality assurance project plan (QAPP)”” is a document required by the EPA for certain activities conducted for or funded by the EPA. The plan outlines the quality assurance criteria, as well as all protocols and quality control measures needed to meet the project data quality objectives. These plans are prepared in accordance with “”EPA Requirements for Quality Assurance Project Plans, EPA QA/R-5,”” (EPA/240/B-01/003 March 2001), which is incorporated by reference in subsection 62-160.800(4), F.A.C. These QAPPs are reviewed and approved by the appropriate EPA office or the Department, when delegated to the Department by EPA for specific activities.
(26) “”Quality control”” is the overall system of technical activities that measures the attributes and performance of a process, product or service against defined standards to verify that they meet the established data quality objectives.
(27) “”Relative percent difference (RPD)”” is a calculated measure used to compare results from duplicate sample analyses. It is calculated as specified in DEP-QA-001/01 (January 2017), which is incorporated by reference in Fl. Admin. Code R. 62-160.800
(28) “”Research method”” is a field procedure or analytical laboratory method that involves the evaluation or use of a new, innovative technology, or as otherwise defined in Fl. Admin. Code R. 62-160.600, and approved by the Department for research purposes.
(29) “”Secondary Use Data”” means data that are being considered for use by the Department for purposes other than that for which the data were originally generated.
(30) “”Spike”” is an environmental sample that has been fortified with a known chemical of interest, at a known concentration. The purpose of a spike is to determine the method recovery efficiency for the chemical of interest, at the fortified concentration level, in the particular environmental sample of interest.
(31) “”Statewide-use method”” is a modified or alternative field or laboratory procedure or method that is submitted to and approved by the Department for the collection or testing of environmental samples by any field sampling organization or laboratory, as applicable, according to Rules 62-160.220 and 62-160.330, F.A.C. The criteria for the validation and approval of a statewide-use method are further outlined in subparts FA 2100 and FA 2200 of DEP SOP FA 1000, which is incorporated by reference in subFl. Admin. Code R. 62-160.800(1)(a)1., and outlined in DEP-QA-001/01, which is incorporated by reference in subsection 62-160.800(5), F.A.C.
(32) “”Surrogate spikes”” are samples fortified at known concentration(s) with one or more compounds having similar chemical characteristics to the compounds of interest, but which are not normally found in environmental samples.
Rulemaking Authority 403.061, 403.0623 FS. Law Implemented 373.026, 373.309, 373.409, 373.413, 373.414, 373.416, 373.4592, 376.303, 376.305, 376.3071, 403.0623, 403.0625, 403.087, 403.088, 403.0881, 403.504, 403.704, 403.707, 403.722, 403.853 FS. History-New 1-1-91, Amended 2-4-93, 2-27-94, Formerly 17-160.120, Amended 3-24-96, 4-9-02, 6-8-04, 12-3-08, 7-30-14, 4-16-18.
Terms Used In Florida Regulations 62-160.120
- Contract: A legal written agreement that becomes binding when signed.
- Dependent: A person dependent for support upon another.
(2) “”Audit”” is a systematic review of laboratory and field protocols to determine if proper procedures are being used and supporting documentation is present. An audit shall consist of an on-site assessment of sample collection, field sampling procedures, laboratory procedures and/or a review, assessment and/or validation of data associated with a Department program activity. If necessary, an audit shall include the submission of performance samples (for example, blind, split and/or performance check samples) to an organization for subsequent use in the evaluation of that organization’s technical performance associated with a specific Department project or program activity.
(3) “”Commercial Vendor”” is a retail or wholesale company whose business is to sell commodities to customers and who is not a part of the process that generates environmental data. These businesses do not include organizations that purchase commodities with the intent of providing the commodities as a service to clients.
(4) “”Common Carrier”” is a business or agency that is available to the general public for the transportation of goods over a definite route and according to a regular schedule.
(5) “”Data quality objectives”” are a set of qualitative and quantitative statements derived from a systematic planning process that clarify the purpose of the study, define the most appropriate type of information to collect, determine the most appropriate conditions from which to collect that information, and specify tolerable levels of potential decision errors.
(6) “”Data validation”” is an evaluation of the technical usability of the verified data with respect to the planned objectives or intention of a project.
(7) “”Data verification”” is a consistent, systematic process that determines whether the data have been collected in accordance with project specifications with respect to compliance, correctness, consistency and completeness as compared to a method standard or contract specification.
(8) “”Department”” is the Florida Department of Environmental Protection.
(9) “”Department-approved method”” is a field procedure or laboratory analytical method specified as acceptable for use in this chapter and in any other Department contract, order, permit or Title 62 rules.
(10) “”Department of Health (DOH) Environmental Laboratory Certification Program (ELCP)”” is the state of Florida’s environmental laboratory certification program, authorized by Florida Statutes § 381.00591, and recognized by the National Environmental Laboratory Accreditation Program (NELAP) Acceditation Council as an authority with responsibility and accountability for granting accreditation for specified fields of laboratory testing through Fl. Admin. Code Chapter 64E-1
(11) “”Electronic signature”” means an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record.
(12) “”Holding time”” is the storage time allowed between sample collection and sample preparation and/or analysis as specified by regulatory requirements or by the field sample collection protocol or laboratory method.
(13) “”Limited-use method”” is an alternative or modified field or laboratory procedure that is approved by the Department for the collection or testing of environmental samples by a single field sampling organization or analytical laboratory for purposes specified in the scope of the approval (e.g., for specified analytes, facility or site locations or types, or sample matrices, such as effluent, groundwater, drinking water, fresh or marine surface waters, soils, sediments, or chemical wastes). A limited-use method that is validated and approved by the Department for a field sampling organization or analytical laboratory may not be used by another field sampling organization or analytical laboratory. The criteria for the validation and approval of a limited-use method are further outlined in subparts FA 2100 and FA 2200 of DEP SOP FA 1000, which is incorporated by reference in subFl. Admin. Code R. 62-160.800(1)(a)1., and outlined in DEP-QA-001/01, which is incorporated by reference in subsection 62-160.800(5), F.A.C. Requirements for limited-use methods are further discussed in Rules 62-160.220 and 62-160.330, F.A.C., and must be met for Department approval.
(14) “”Matrix”” is the predominant material in which an analyte of interest is contained. For example, soil, groundwater and drinking water are three environmental matrices.
(15) “”Method-defined analyte”” is defined by the U.S. Environmental Protection Agency as an analyte whose result is totally dependent on how the measurement is made. Any changes or modifications in the preparation or determinative techniques of these methods have the potential of changing the result, and are not approved by the Department, as indicated in Fl. Admin. Code R. 62-160.330(2)(a) Examples are: Carbonaceous Biological Oxygen Demand, Oil and Grease, and Toxicity Characteristic Leaching Procedure (TCLP).
(16) “”Method detection limit (MDL)”” is an estimate of the minimum amount of a substance that an analytical process can reliably detect, the minimum measured concentration of a substance that can be reported with 99% confidence that the measured concentration is distinguishable from method blank results, or the minimum result that can be reliably discriminated from a blank with a predetermined confidence level (Limit of Detection [LOD] as defined in the 2016 TNI Standards, which are incorporated by reference in Fl. Admin. Code R. 62-160.800(3)(b)). The Department accepts any of the preceding definitions of the MDL. An MDL is analyte-specific and matrix-specific and is laboratory-dependent. The MDL for an analyte is determined from the preparation and analysis of a sample in a given matrix containing the analyte. MDLs shall be determined for each matrix/analytical technology/analyte combination reported by the laboratory, except for those tests where determination of the MDL is not appropriate for the analytical technique, such as biochemical oxygen demand, chlorophyll or microbiological tests. When required according to Department rules, MDLs shall be calculated following the procedure specified in those rules. If not specified in Department rules, MDLs may be determined and verified by any technically justifiable and scientifically sound method appropriate for the test. For the purposes of data usability evaluation, the DEP-defined MDL is equivalent to the Limit of Detection (LOD) as defined in the 2016 TNI Standards, which are incorporated by reference in Fl. Admin. Code R. 62-160.800(3)(b)
(17) “”Method modification”” is any change that alters the scope, applicability, specifications, steps, performance criteria, or any other requirements described in a published field procedure or laboratory analytical method, as further specified in subsections 62-160.220(3) and 62-160.330(3), F.A.C. The resultant method is defined by the Department as a “”modified method.””
(18) “”Field of Accreditation Matrix”” is defined in the Glossary of the 2003 NELAC Standards, which is incorporated by reference in Fl. Admin. Code R. 62-160.800(3)(a), and shall be used to determine matrices under which a laboratory must be certified by the DOH ELCP for reporting data to be used by the Department:
(a) Drinking Water: any aqueous sample that has been collected from a water source designated by the Department as a potable or potential potable water source.
(b) Non-potable Water: any aqueous sample excluded from the definition of drinking water matrix including surface water, groundwater, effluents, water treatment chemicals, or samples derived from synthetic precipitation leaching procedures (SPLP), toxicity characteristic leaching procedures (TCLP) or other extracts. To be considered as non-potable water, water treatment chemicals must be in an aqueous solution. If the laboratory receives the original environmental sample as a solid or chemical material for SPLP or TCLP extraction, the laboratory must be certified for the SPLP or TCLP extraction in the Solid and Chemical Material matrix. For the analytical tests to be performed on the SPLP or TCLP extract, the laboratory must be certified in the non-potable water matrix for at least one method for each analytical technology/analyte combination for each reported analyte.
(c) Solid and Chemical Materials: includes soils, sediments, sludges, products and by-products of an industrial process that results in a matrix not previously defined. For purposes of accreditation, biosolids are considered a solid, unless the sample matrix comprises liquid biosolids as defined in Fl. Admin. Code Chapter 62-640 All other sample matrices not previously defined and comprising ≤ 15% settleable solids are liquids, and may require laboratory certification for analysis using techniques for non-potable water or liquid chemical materials.
(d) Biological Tissue: any sample of a biological origin, such as fish, shellfish, macroinvertebrates, algae, or plant material.
(19) “”National Environmental Laboratory Accreditation Program (NELAP)”” is a program that implements standards that have been found to be acceptable to the NELAP Accreditation Council.
(20) “”NELAP accreditation”” is an accreditation status applied to a laboratory’s field(s) of testing upon satisfying all requirements for certification as provided in Fl. Admin. Code Chapter 64E-1
(21) “”Percent relative standard deviation (% RSD)”” is a calculated measure of precision from results of replicate sample analyses. It is calculated as specified in DEP-QA-001/01 (January 2017), which is incorporated by reference in Fl. Admin. Code R. 62-160.800
(22) “”Permit”” is any permit or license issued by the Department pursuant to its lawful authority, or by another government agency under delegation of authority from the Department.
(23) “”Practical quantitation limit (PQL)”” is the lowest level of measurement that can be reliably achieved during routine laboratory operating conditions within specified limits of precision and accuracy. The value of the PQL shall be greater that the MDL value except when analytical quality control problems necessitate raising the MDL value equal to or above the PQL value for a specific sample, or when determination of the MDL is not appropriate for an analytical technique, as indicated below. A laboratory may determine and verify the PQL by any technically justifiable d scientifically sound method appropriate for the test, unless otherwise required by Department rule, contract, order, or permit. For Departmental use, if a laboratory fails to report a PQL, the PQL shall be calculated as four times the MDL, except for those tests where determination of the MDL is not appropriate for the analytical technique (e.g., biochemical oxygen demand, chlorophyll or microbiological tests). In such cases, the Department shall use all available information about the technique to determine the PQL. For the purposes of data usability evaluation, the DEP-defined PQL is equivalent to the Limit of Quantitation (LOQ) as defined in the 2016 TNI Standards, which are incorporated by reference in Fl. Admin. Code R. 62-160.800(3)(b)
(24) “”Quality assurance”” is an integrated system of management activities involving planning, implementation, documentation, assessment, reporting and quality improvement to ensure that a process, product or service meets defined standards of quality.
(25) “”Quality assurance project plan (QAPP)”” is a document required by the EPA for certain activities conducted for or funded by the EPA. The plan outlines the quality assurance criteria, as well as all protocols and quality control measures needed to meet the project data quality objectives. These plans are prepared in accordance with “”EPA Requirements for Quality Assurance Project Plans, EPA QA/R-5,”” (EPA/240/B-01/003 March 2001), which is incorporated by reference in subsection 62-160.800(4), F.A.C. These QAPPs are reviewed and approved by the appropriate EPA office or the Department, when delegated to the Department by EPA for specific activities.
(26) “”Quality control”” is the overall system of technical activities that measures the attributes and performance of a process, product or service against defined standards to verify that they meet the established data quality objectives.
(27) “”Relative percent difference (RPD)”” is a calculated measure used to compare results from duplicate sample analyses. It is calculated as specified in DEP-QA-001/01 (January 2017), which is incorporated by reference in Fl. Admin. Code R. 62-160.800
(28) “”Research method”” is a field procedure or analytical laboratory method that involves the evaluation or use of a new, innovative technology, or as otherwise defined in Fl. Admin. Code R. 62-160.600, and approved by the Department for research purposes.
(29) “”Secondary Use Data”” means data that are being considered for use by the Department for purposes other than that for which the data were originally generated.
(30) “”Spike”” is an environmental sample that has been fortified with a known chemical of interest, at a known concentration. The purpose of a spike is to determine the method recovery efficiency for the chemical of interest, at the fortified concentration level, in the particular environmental sample of interest.
(31) “”Statewide-use method”” is a modified or alternative field or laboratory procedure or method that is submitted to and approved by the Department for the collection or testing of environmental samples by any field sampling organization or laboratory, as applicable, according to Rules 62-160.220 and 62-160.330, F.A.C. The criteria for the validation and approval of a statewide-use method are further outlined in subparts FA 2100 and FA 2200 of DEP SOP FA 1000, which is incorporated by reference in subFl. Admin. Code R. 62-160.800(1)(a)1., and outlined in DEP-QA-001/01, which is incorporated by reference in subsection 62-160.800(5), F.A.C.
(32) “”Surrogate spikes”” are samples fortified at known concentration(s) with one or more compounds having similar chemical characteristics to the compounds of interest, but which are not normally found in environmental samples.
Rulemaking Authority 403.061, 403.0623 FS. Law Implemented 373.026, 373.309, 373.409, 373.413, 373.414, 373.416, 373.4592, 376.303, 376.305, 376.3071, 403.0623, 403.0625, 403.087, 403.088, 403.0881, 403.504, 403.704, 403.707, 403.722, 403.853 FS. History-New 1-1-91, Amended 2-4-93, 2-27-94, Formerly 17-160.120, Amended 3-24-96, 4-9-02, 6-8-04, 12-3-08, 7-30-14, 4-16-18.