Subchapter A. GENERAL PROVISIONS
Sec.
252.1. Definitions.
252.2. Purpose.
252.3. Scope.
252.4. General requirements.
252.5. NELAP equivalency.
252.6. Accreditation-by-rule.§ 252.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
Acceptance criteria—Specified limits placed on a measurement, quality control sample or process.
Accreditation—A determination by the Department that an environmental laboratory is capable of performing one or more classes of testing or analysis of environmental samples in accordance with the act and this chapter.
Accreditation body—A territorial, State or Federal agency having responsibility and accountability for environmental laboratory accreditation and which grants accreditation.
Accreditation-by-rule—Accreditation which an environmental laboratory is deemed to have for the fields of accreditation identified in § 252.6 (relating to accreditation-by-rule) upon compliance with that section.
Act—27 Pa.C.S. § § 4101—4113 (relating to environmental laboratory accreditation).
Action level—The concentration of a contaminant which, if exceeded, triggers a treatment or other requirement which a water system must follow.
Analysis day—A continuous 24-hour period during which testing or analysis of environmental samples is performed.
Analyst—An individual who performs the analytical methods and associated techniques and who is responsible for applying the required laboratory practices and quality controls to meet the required level of quality.
Analyte—The component, compound, element or isotope to be identified or quantified using a test or analysis.
Batch—Environmental samples that are prepared or analyzed together using the same procedures, personnel, lots of reagents and standards.
Batch, analytical—A batch composed of prepared environmental samples that are analyzed together as a group. An analytical batch may contain samples originating from various environmental matrices and can exceed 20 samples.
Batch, preparation—A batch composed of 1 to 20 environmental samples of the same matrix with a maximum time between the start of processing of the first and last sample in the batch to be 24 hours.
Calibration verification standard—A standard used to confirm the validity of a previously performed initial calibration of a measurement process.
Certificate of accreditation—A document issued by the Department certifying that an environmental laboratory has met standards for accreditation.
Commonwealth agency—An agency that is a Commonwealth agency as that term is defined under 62 Pa.C.S. § 103 (relating to definitions.)
Deficiency—A deviation from acceptable procedures or practices.
Detection limit—The lowest concentration or amount of the target analyte that can be identified, measured and reported with confidence that the analyte concentration is not zero.
Drinking water—Any aqueous sample that has been collected for the purposes of demonstrating compliance with the Pennsylvania Safe Drinking Water Act (35 P. S. § § 721.1—721.17) or is from a potable or potential potable water source.
ECp—Effective concentration percent—The concentration that affects the test variable at p percent from the control value.
Environmental laboratory—A facility engaged in the testing or analysis of environmental samples.
Environmental sample—A solid, liquid, gas or other specimen taken for the purpose of testing or analysis as required by an environmental statute.
Environmental statute—A statute administered by the Department relating to the protection of the environment or of public health, safety and welfare.
Facility—A sole proprietor, partnership, corporation, association, institution, cooperative enterprise, municipal authority, political subdivision, Federal government or agency, state institution or agency or other legal entity which is recognized by law as the subject of rights and duties.
Field of accreditation—A combination of matrix; method or technology, or both; and analyte or analyte group for which an environmental laboratory may be accredited. Examples are:(i) Nonpotable water; GC/MS, US EPA Method 625; benzo(a)pyrene.
(ii) Drinking water; ICP, US EPA Method 200.7; magnesium.
(iii) Drinking water; GC/MS, US EPA Method 524.2; total trihalomethanes.
Holding time—The maximum elapsed time from sample collection to initiation of testing or analysis.
ICp—Inhibition concentration percent—The concentration that inhibits the test variable at p percent from the control value.
Industrial wastewater treatment facility—Any facility that treats industrial waste or pollution, but not sewage, as those terms are defined in The Clean Streams Law (35 P. S. § § 691.1—691.1001).
Initial calibration—Determination by measurement or comparison with a standard of known concentration the correct value or response of each scale reading on a meter, instrument or other device. Comparison of a measurement standard or instrument with another standard or instrument to report or eliminate by adjustment any variation in the accuracy of the item being compared.
Initial demonstration of capability—A procedure to establish the ability of an analyst, technical staff member or work cell to generate data of acceptable accuracy and precision.
LCp—Lethal concentration percent—The concentration that is lethal to p percent of the test organisms from the control organisms.
Laboratory control sample—A sample of a controlled matrix known to be free of the analyte of interest, to which a known and verified concentration of analyte has been added and that is taken through all preparation and analytical steps in the method.
Laboratory management—(i) The individuals responsible for the overall operation, all personnel and the physical plant of an environmental laboratory.
(ii) The term includes the laboratory supervisor.
Laboratory notebook—A chronological record of observations, results of testing or analysis, equipment maintenance or calibration or other environmental laboratory data. A laboratory notebook may be maintained in an electronic format.
Laboratory supervisor—A technical supervisor of an environmental laboratory who supervises laboratory procedures and reporting of analytical data.
Linear range—The range of concentrations over which the instrument response is directly proportional to the analyte concentration.
MCL—Maximum Contaminant Level—The maximum permissible level of a contaminant in water which is delivered to a user of a public water system, and includes the primary and secondary MCLs established under the Safe Drinking Water Act (42 U.S.C.A. § § 300f—300j-10) and MCLs adopted under the Pennsylvania Safe Drinking Water Act and the regulations promulgated thereunder.
Matrix or matrices—The media of an environmental sample that includes drinking water, nonpotable water, and solid and chemical materials.
Matrix spike—A sample prepared by adding a known mass of target analyte to a specified amount of environmental sample and that is taken through all preparation and analytical steps in the method.
Method—The scientific technique used to perform testing or analysis on an environmental sample.
Method blank—A sample of a known matrix, similar to the associated samples, and known to be free of the analyte of interest and that is taken through all preparation and analytical steps in the method.
Mobile laboratory—(i) A portable enclosed structure within which testing or analysis of environmental samples occurs.
(ii) Examples include trailers, vans and skid mounted structures configured to house environmental testing equipment and personnel.
NELAC—National Environmental Laboratory Accreditation Conference.
NELAP—National Environmental Laboratory Accreditation Program.
NELAP accreditation body—An accreditation body that has been recognized as meeting the requirements of the NELAC Standard or the TNI Standard and has the authority to grant NELAP accreditation.
NIST—The National Institute of Standards and Technology of the United States Department of Commerce’s Technology Administration.
NOAEC—No observed adverse effect concentration.
NOEC—No observed effect concentration.
Negative culture control—An organism selected to demonstrate that the medium does not support the growth of nontarget organisms or does not demonstrate the typical positive reaction of the target organisms.
Nonpotable water—(i) Any aqueous sample excluded from the definition of drinking water matrix.
(ii) The term includes wastewater, ambient water, surface water, groundwater, effluents, water treatment chemicals and leachates.
Positive culture control—An organism selected to demonstrate that the medium can support the growth of the target organisms and that the medium produces the specified or expected reaction to the target organism.
Primary accreditation—Accreditation received from the Department that is not based upon accreditation from another accreditation body.
Proficiency test reporting limit—The value that corresponds to the lowest acceptable result that could be obtained from the lowest spike level for each analyte in a proficiency test sample.
Proficiency test study—A sample or group of samples, the composition of which is unknown to the environmental laboratory and the analyst.
Promulgated method—A protocol for testing or analysis of a specific analyte that is approved for use by a State or Federal regulation.
Quality manual—A document stating, or making reference to, the policies, objectives, principles, responsibilities, accountability, implementation plans, methods, operating procedures or other documents of an environmental laboratory for ensuring the quality of its testing and analysis.
Quantitation limit—The minimum concentration or activity of the component, compound, element or isotope that can be reported with a specified degree of confidence. Typically it is the concentration that produces a signal ten standard deviations above the reagent water blank signal.
Range of quantitation—The concentration range between which an environmental laboratory reports results quantitatively which is defined by a low concentration standard and a high concentration standard.
Reagent water—Water with no detectable concentration of the component, compound, element or isotope to be analyzed and that is free of substances that interfere with the method. Reagent water may be prepared by distillation, ion exchange, adsorption, reverse osmosis or a combination thereof.
Revocation—Removal by the Department of one or more fields of accreditation from an environmental laboratory.
Sample duplicate—Replicate aliquots of the same sample taken through the entire analytical procedure.
Secondary accreditation—Accreditation received from the Department based upon the accreditation status granted by another accreditation body.
Solid and chemical materials—Soils, sediments, sludges, solid waste, drill cuttings, overburden, minerals, coal ash, and products and by-products of an industrial process that result in a matrix that is not otherwise defined.
Solid waste—Any waste, including, but not limited to, municipal, residual or hazardous wastes, including solid, liquid, semisolid or contained gaseous materials as that term is defined in the Solid Waste Management Act (35 P. S. § § 6018.101—6018.1003).
Spike—A known and verified mass or activity of the target analyte of interest added to reagent water or environmental sample to determine recovery efficiency or for other quality control purposes.
Standard operating procedure—A written document that provides detailed instructions for the performance of all aspects of test, analysis, operation or action.
Surrogate—A substance with properties similar to the analyte of interest. A surrogate is unlikely to be found in an environmental sample. A surrogate is added to an environmental sample prior to all preparation and analytical steps in the method for quality control purposes.
Suspension—The temporary removal by the Department of one or more fields of accreditation from an environmental laboratory for a period not to exceed 6 months.
Technical staff—Employees of an environmental laboratory that perform any portion of testing or analysis of environmental samples, including the analysts of the environmental laboratory.
Test—A technical operation that consists of the determination of one or more characteristics or performance of a given product, material, equipment, organism, physical phenomenon, process or service according to a specified procedure.
TNI—The NELAC Institute or its successor organization/Standard.
Wastewater—A substance that contains the waste products or excrement or other discharge from the bodies of human beings or animals and noxious or deleterious substances being harmful or inimical to the public health, or to animal or aquatic life, or to the use of water for domestic water supply or for recreation, or which constitutes pollution under The Clean Streams Law.
Wastewater facility—A facility that operates a system designed to collect, convey or treat wastewater and from which effluent is discharged into waters of this Commonwealth.
Work area—The areas in an environmental laboratory necessary for testing and analysis and related activities. These areas include sample receipt area, sample storage area, chemical and waste storage area, data handling area and analytical areas.
Work cell—A defined group of analysts that together perform testing or analysis of environmental samples.
Authority The provisions of this § 252.1 amended under 27 Pa.C.S. § § 4103(a), 4104 and 4105; and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
Source The provisions of this § 252.1 amended April 9, 2010, effective April 10, 2010, 40 Pa.B. 1898; amended July 28, 2017, effective July 29, 2017, 47 Pa.B. 4085. Immediately preceding text appears at serial pages (348779) to (348785).
§ 252.2. Purpose.
The purpose of this chapter is to protect public health, safety, welfare and the environment by ensuring the accuracy, precision and reliability of data generated by environmental laboratories by establishing an accreditation program for environmental laboratories.
§ 252.3. Scope.
(a) Environmental statutes. This chapter applies to facilities that test or analyze environmental samples in the matrices listed in subsection (b) for the purpose of complying with the following environmental statutes:
(1) 58 Pa.C.S. Chapter 32 (relating to development).
(2) The Clean Streams Law (35 P.S. § § 691.1—691.1001).
(3) The Hazardous Sites Cleanup Act (35 P.S. § § 6020.101—6020.1305).
(4) The Land Recycling and Environmental Remediation Standards Act (35 P.S. § § 6026.101—6026.908).
(5) The Pennsylvania Safe Drinking Water Act (35 P.S. § § 721.1—721.17).
(6) The Solid Waste Management Act (35 P.S. § § 6018.101—6018.1003).
(7) The Storage Tank and Spill Prevention Act (35 P.S. § § 6021.101—6021.2104).
(8) The Bituminous Coal Mine Safety Act (52 P.S. § § 690-101—690-708).
(9) The Surface Mining Conservation and Reclamation Act (52 P.S. § § 1396.1—1396.19b).
(10) The Coal Refuse Disposal Control Act (52 P.S. § § 30.51—30.66).
(11) The Bituminous Mine Subsidence and Land Conservation Act (52 P.S. § § 1406.1—1406.21).
(12) The Noncoal Surface Mining Conservation and Reclamation Act (52 P.S. § § 3301—3326).
(b) Matrix. The following matrices are included:
(1) Drinking water.
(2) Nonpotable water.
(3) Solid and chemical materials.
(c) Exclusions. The following testing and analysis are specifically excluded from the requirements of this chapter:
(1) Corrosion protection system testing or testing of a storage tank system for tightness or structural soundness under Chapter 245 (relating to administration of the storage tank and spill prevention program).
(2) Routine release detection monitoring under § § 245.442—245.445, 245.543 and 245.613.
(3) Analyses to determine the acceptability of soils for protective, daily, intermediate and final cover material, subbase, clay liner, clay cap, attenuating soil base and liner system construction material under Chapters 260a, 261a, 262a, 263a, 264a, 265a, 266a, 266b, 268a, 269a, 270a, 271—273, 275, 277, 279, 281, 283—285, 287—289, 291, 293, 295 and 297—299.
(4) Testing or analysis of the physical, chemical, mechanical and thermal properties of liners, liner systems, leachate detection zones and barriers under Chapters 260a, 261a, 262a, 263a, 264a, 265a, 266a, 266b, 268a, 269a, 270a, 271—273, 275, 277, 279, 281, 283—285, 287—289, 291, 293, 295 and 297—299.
Authority The provisions of this § 252.3 amended under 27 Pa.C.S. § 4105(a); and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
Source The provisions of this § 252.3 amended July 28, 2017, effective July 29, 2017, 47 Pa.B. 4085. Immediately preceding text appears at serial pages (348785) to (348786).
Cross References This section cited in 25 Pa. Code § 252.4 (relating to general requirements); and 25 Pa. Code § 252.201 (relating to application and supporting documents).
§ 252.4. General requirements.
(a) Testing or analysis of environmental samples within a matrix identified in § 252.3 (relating to scope) and to comply with a statute listed in § 252.3 shall be performed by an environmental laboratory accredited under this chapter.
(b) An environmental laboratory testing, analyzing or reporting results for environmental samples in a matrix identified in § 252.3 and required by a statute identified in § 252.3 shall be accredited and in compliance with this chapter to generate data and perform analysis used to comply with an environmental statute listed in § 252.3.
Authority The provisions of this § 252.4 amended under 27 Pa.C.S. § § 4103(2), 4104 and 4105; and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
Source The provisions of this § 252.4 amended April 9, 2010, effective April 10, 2010, 40 Pa.B. 1898; amended July 28, 2017, effective July 29, 2017, 47 Pa.B. 4085. Immediately preceding text appears at serial page (348786).
§ 252.5. NELAP equivalency.
(a) An environmental laboratory may apply to the Department for NELAP accreditation for the fields of accreditation for which the Department offers accreditation.
(b) An environmental laboratory seeking NELAP accreditation shall:
(1) Submit a complete application as provided in Subchapter B (relating to application, fees and supporting documents).
(2) Comply with Subchapter E (relating to proficiency test study requirements).
(3) Comply with Subchapter F (relating to assessment requirements).
(4) Comply with Subchapter G (relating to miscellaneous provisions).
(5) Comply with the current edition of the NELAC Standard or TNI Standard.
(6) Comply with § 252.307 (relating to methodology).
(7) Comply with § 252.401 (relating to basic requirements).
(c) An environmental laboratory receiving NELAP accreditation from the Department may apply for accreditation under the remainder of this chapter for the fields of accreditation that are not included in NELAP accreditation and for which the Department offers accreditation.
(d) An environmental laboratory receiving NELAP accreditation from the Department may only test or analyze environmental samples within the fields of accreditation authorized by the accreditation received from the Department.
Authority The provisions of this § 252.5 amended under 27 Pa.C.S. § § 4103(a), 4104 and 4105; and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
Source The provisions of this § 252.5 amended April 9, 2010, effective April 10, 2010, 40 Pa.B. 1898; amended July 28, 2017, effective July 29, 2017, 47 Pa.B. 4085. Immediately preceding text appears at serial pages (348786) to (348787).
Cross References This section cited in 25 Pa. Code § 252.205 (relating to out-of-State laboratories).
§ 252.6. Accreditation-by-rule.
(a) Purpose. Environmental laboratories performing testing or analysis or reporting results described in this section will be deemed to have accreditation-by-rule if the following general requirements are met:
(1) The environmental laboratory registers with the Department in accordance with 27 Pa.C.S. § 4107(a) (relating to interim requirements).
(2) The environmental laboratory performs the testing or analysis in conformance with applicable State or Federal laws, regulations, promulgated methods, orders and permit conditions.
(3) The environmental laboratory assures that samples for testing or analysis are properly preserved, are in proper containers, do not exceed maximum holding times between collection and analysis, and are handled in accordance with applicable State or Federal laws, regulations, promulgated methods, orders and permit conditions.
(4) The environmental laboratory has the other necessary permits under the applicable environmental protection acts and is operating under the acts and regulations promulgated thereunder and the terms and conditions of permits.
(5) Records pertaining to the testing or analysis of environmental samples are retained onsite and in accordance with § 252.706 (relating to recordkeeping). Records shall be made available to the Department upon request.
(6) The environmental laboratory is reporting only the results of the testing or analysis of environmental samples specified in subsections (c) and (f) in conformance with the applicable State or Federal laws, regulations, orders or permit conditions.
(b) Inappropriate activity. The Department may require an environmental laboratory deemed to have accreditation-by-rule to apply for, and obtain, environmental laboratory accreditation under Subchapter B (relating to application, fees and supporting documents), or take other appropriate action, when the environmental laboratory is not in compliance with the conditions of accreditation-by-rule or is conducting an activity that harms or presents a threat of harm to the health, safety or welfare of the people or the environment of this Commonwealth.
(c) Testing and analysis of samples from public water suppliers. An environmental laboratory using an individual meeting the requirements specified in § 109.704 (relating to operator certification) and in compliance with subsections (a) and (b) will be deemed to be accredited under this chapter to perform only those measurements identified in § 109.304(c) (relating to analytical requirements) as measurements that may be performed by a person meeting the requirements of § 109.704.
(d) Industrial wastewater treatment facility laboratory. An environmental laboratory operated by an industrial wastewater treatment facility in compliance with subsections (a) and (b) will be deemed to be accredited under this chapter to perform testing or analysis not mandated by the Department and those tests identified in subsection (f).
(e) Wastewater facility laboratory. An environmental laboratory operated by a wastewater facility in compliance with subsections (a) and (b) will be deemed to be accredited under this chapter to perform testing or analysis not mandated by the Department and those tests identified in subsection (f).
(f) Other testing and analysis. With the exception of environmental laboratories testing or analyzing environmental samples to comply with the Pennsylvania Safe Drinking Water Act (35 P. S. § § 721.1—721.17), an environmental laboratory in compliance with subsections (a) and (b) will be deemed accredited under this chapter for the following tests or analyses:
(1) Alkalinity.
(2) Carbon dioxide (CO2).
(3) Color.
(4) Conductivity.
(5) Dissolved oxygen.
(6) Field radioactivity using hand held survey instruments.
(7) Flash point and total halogen determination on waste oil by a waste oil transporter or waste oil transfer facility as required by § 298.44 (relating to rebuttable presumption for waste oil and flash point screening).
(8) Flow.
(9) Foam.
(10) Hardness.
(11) Odor.
(12) Oxidation reduction potential.
(13) Paint filter test.
(14) pH.
(15) Residual disinfectant concentration.
(16) Settleable solids.
(17) Sheen.
(18) Sludge volume index.
(19) Specific gravity.
(20) Sulfite.
(21) Taste.
(22) Temperature.
(23) Turbidity.
(24) Vapor analysis using hand held survey instruments.
(25) Volatile acids in wastewater and sludge.
(g) Exclusion from requirements. An environmental laboratory deemed to be accredited under this section is not required to meet any other requirements in this chapter.
Authority The provisions of this § 252.6 amended under 27 Pa.C.S. § § 4103(a), 4104 and 4105; and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
Source The provisions of this § 252.6 amended April 9, 2010, effective April 10, 2010, 40 Pa.B. 1898; amended July 28, 2017, effective July 29, 2017, 47 Pa.B. 4085. Immediately preceding text appears at serial pages (348787) to (348789).
Cross References This section cited in 25 Pa. Code § 252.1 (relating to definitions).
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