[35 Pa.B. 519]
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Annex A
TITLE 25. ENVIRONMENTAL PROTECTION
PART I. DEPARTMENT OF ENVIRONMENTAL PROTECTION
Subpart D. ENVIRONMENTAL HEALTH AND SAFETY
ARTICLE VI. GENERAL HEALTH AND SAFETY
CHAPTER 252. ENVIRONMENTAL LABORATORY ACCREDITATION Subchap.
A. GENERAL PROVISIONS
B. APPLICATION, FEES AND SUPPORTING DOCUMENTS
C. GENERAL STANDARDS FOR ACCREDITATION
D. QUALITY ASSURANCE AND QUALITY CONTROL REQUIREMENTS
E. PROFICIENCY TEST STUDY REQUIREMENTS
F. ONSITE ASSESSMENT REQUIREMENTS
G. MISCELLANEOUS PROVISIONS
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-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.
Accrediting authority--A territorial, state or Federal agency having responsibility and accountability for environmental laboratory accreditation and which grants accreditation.
Act--27 Pa.C.S. §§ 4101--4113 (relating to environmental laboratory accreditation).
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.)
Confirmation--Verification of the identity of an analyte through the use of a test or analysis using a different scientific principle from the original test or analysis.
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.
Laboratory supervisor--A technical supervisor of an environmental laboratory who supervises laboratory procedures and reporting of 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.
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.
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 accrediting authority--An accrediting authority that has been recognized as meeting the requirements of the NELAC standards 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--Any aqueous sample excluded from the definition of drinking water matrix. The term includes wastewater, ambient water, surface water, groundwater, effluents, water treatment chemicals and toxicity characteristic leaching procedure or other extracts.
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 accrediting authority.
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.
Relative standard deviation--The coefficient of variation expressed as a percentage.
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 accrediting authority.
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).
Standard operating procedure--A written document that provides detailed instructions for the performance of all aspects of test, analysis, operation or action.
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.
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.
§ 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 following environmental statutes:
(1) The Oil and Gas Act (58 P. S. §§ 601.101--601.605).
(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 Pennsylvania Bituminous Coal Mine Act (52 P. S. §§ 701-101--701-706).
(9) The Surface Mining Conservation and Reclamation Act (52 P. S. §§ 1396.1--1369.31).
(10) The Coal Refuse Disposal Control Act (52 P. S. §§ 30.51--30.206).
(11) The Bituminous Mine Subsidence and Land Conversion Act (52 P. S. §§ 1406.1--1406.21).
(12) The Noncoal Surface Mining Conservation and Reclamation Act (52 P. S. §§ 3001--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 is 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 the 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 260--270 (relating to hazardous waste), Chapters 271--285 (relating to municipal waste) and Chapters 287--299 (relating to residual waste.)
(4) Testing or analysis of the physical, chemical, mechanical and thermal properties of liners, liner systems, leachate detection zones and barriers under Chapters 260--270, 271--285 and 287--299.
§ 252.4. General requirements.
(a) Testing or analysis of environmental samples within a matrix identified in § 252.3 (relating to scope) and in order 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 or analyzing 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 in order to generate data and perform analysis used to comply with an environmental statute listed in § 252.3.
§ 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 G (relating to miscellaneous provisions).
(c) An environmental laboratory receiving NELAP accreditation from the Department may only test or analyze environmental samples within the fields of accreditation authorized by the NELAP accreditation received from the Department.
(d) 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.
§ 252.6. Accreditation-by-rule.
(a) Purpose. Environmental laboratories performing testing or analysis described in this section will be deemed to have accreditation-by-rule if the following general requirements are met:
(1) When required by State or Federal laws, regulations, an order or permit conditions, the environmental laboratory shall perform the testing or analysis in conformance with promulgated methods and guidelines established by the Department.
(2) 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 guidelines governing quality control established by the Department.
(3) 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.
(4) Records pertaining to the testing or analysis of environmental samples are retained onsite and in accordance with § 252.707 (relating to recordkeeping). Records shall be made available to the Department upon request.
(5) The environmental laboratory is reporting the results of the testing or analysis of environmental samples 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) 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 those measurements identified in Chapter 109, Subchapter C (relating to monitoring 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 identified in subsection (c), 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.
(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.
Subchapter B. APPLICATION, FEES AND SUPPORTING DOCUMENTS Sec.
252.201. Application and supporting documents. 252.202. Application for transfer of laboratory accreditation. 252.203. Accreditation renewal. 252.204. Fees. 252.205. Out-of-State laboratories. 252.206. Out-of-State onsite reimbursement. § 252.201. Application and supporting documents.
(a) An environmental laboratory seeking accreditation for one or more fields of accreditation within a matrix described in § 252.3 (relating to scope) or that seeks to add a field of accreditation, shall apply to the Department for accreditation in writing on forms provided by the Department. The applicant shall provide other relevant material requested by the Department.
(b) An application for accreditation shall include the appropriate application fee in accordance with § 252.204 (relating to fees.)
(c) Environmental laboratories maintained on separate premises shall maintain distinct accreditation. Separate accreditation is not required for environmental laboratories in different buildings on the same or adjoining grounds, provided the laboratories are operated under the same management.
(d) Separate accreditation is required for a mobile laboratory.
§ 252.202. Application for transfer of laboratory accreditation.
(a) The new owner of an accredited environmental laboratory shall notify the Department in writing within 10 calendar days following a change in laboratory ownership. Within 30 calendar days following the change in laboratory ownership, an accredited environmental laboratory shall do the following:
(1) Submit an ownership transfer application, indicating any changes in the equipment, methodology and staffing.
(2) Pay the application fee for ownership transfer.
(3) Agree to correct any violations that exist at the time of the sale or transfer in accordance with a schedule that is acceptable to the Department.
(b) Open or pending enforcement actions will be transferred with the accreditation.
(c) Failure to comply with this section will cause the previous accreditation to expire.
(d) An environmental laboratory may operate under the previous accreditation until the Department makes a final decision on the transfer application. If the Department denies the transfer application, the environmental laboratory is no longer accredited and the new owner shall submit an application under § 252.201 (relating to application and supporting documents).
§ 252.203. Accreditation renewal.
(a) Applications for accreditation renewal shall be submitted annually to the Department at least 60 calendar days prior to the expiration date of the current certificate of accreditation on forms provided by the Department.
(b) Failure to submit an application for renewal in accordance with this section will result in a lapse in accreditation if the Department has not approved the renewal application prior to the expiration of the current certificate of accreditation. If a lapse in accreditation occurs, the environmental laboratory shall cease all testing or analysis of environmental samples for the affected fields of accreditation.
§ 252.204. Fees.
(a) The appropriate fee in accordance with the following schedule shall accompany the application for accreditation. The Department may establish a list of equivalent methods that will be considered a single method with regard to fees. A check must be payable to ''Commonwealth of Pennsylvania.'' The fees effective through December 31, 2008, are as follows:
Category Fee Application fee--initial and renewal $700 Application fee--ownership transfer $150 Application fee--addition of fields of accreditation $150 Basic nonpotable water category (Fecal coliform bacteria, BOD, CBOD, residue, nitrate, ammonia, total nitrogen, phosphorus) $750 Basic drinking water category (Total coliform bacteria, fecal coliform bacteria, heterotropic bacteria, nitrate, nitrite, fluoride, cyanide) $700 Asbestos category $500 Microbiology--basic, first method (includes 1 method each for total coliform, fecal coliform, E.coli, and heterotropic bacteria) $300 Microbiology--basic, each additional method $100 Microbiology--nonbasic each method $250 Maximum fee for microbiology category $1,000 Trace metal category, first method $350 Trace metal category each additional method $150 Maximum fee for trace metal category $1,200 Inorganic nonmetal category, first method $350 Inorganic nonmetal category, each additional method $100 Maximum fee for inorganic nonmetal category $2,500 Gas chromatography--volatiles category, first method $400 Gas chromatography--volatiles category, each additional method $100 Maximum fee for gas chromatography--volatiles category $1,000 Gas chromatography/mass spectrometry--vola- tiles category, first method $450 Gas chromatography/mass spectrometry--vola- tiles category, each additional method $150 Maximum fee for gas chromatography/mass spectrometry--volatiles category $1,000 Gas chromatography--extractable category, each method $400 Maximum fee for gas chromatography extractable category $3,000 Gas chromatography/mass spectrometry-- extractable category, first method $500 Gas chromatography/mass spectrometry-- extractable category, each additional method $250 Maximum fee for gas chromatography/mass spectrometry extractable category $2,000 Other organic including liquid chromatography, each method $350 Maximum fee for other organic category $2,000 Dioxin category, each method $500 Radiochemical category, first method $500 Radiochemical category, each additional method $250 Maximum fee for radiochemical category $1,500 Whole effluent toxicity testing category $500 (b) The fees imposed under subsection (a) will be increased every 3 years beginning January 1, 2009. The initial fee increase will be by the percentage, if any, by which the Consumer Price Index for the calendar year 2008 exceeds the Consumer Price Index for the calendar year 2005. Subsequent fee increases shall be by the percentage, if any, by which the Consumer Price Index for the current calendar year exceeds the Consumer Price Index for the calendar year of the previous fee increase. For the purposes of this subsection:
(1) The Consumer Price Index for any calendar year is the average of the Consumer Price Index for All-Urban Consumers, published by the United States Department of Labor, as of the close of the 12 month period ending on June 30.
(2) The revision of the Consumer Price Index that is most consistent with the Consumer Price Index for calendar year 2005 shall be used.
(3) The Department will publish the revised fee table in the Pennsylvania Bulletin at least 90 days prior to the effective date of the revision.
(c) An environmental laboratory owned or operated by a Commonwealth agency is exempt from this fee requirement, but shall apply for accreditation under this chapter.
(d) Fees are nonrefundable.
(e) In addition to the nonrefundable application fee, an out-of-State environmental laboratory shall reimburse the Department for the costs associated with onsite assessments necessitated by accreditation as specified § 252.206 (relating to out-of-State onsite reimbursement).
§ 252.205. Out-of-State laboratories.
(a) Out-of-State environmental laboratories may apply for primary accreditation or secondary accreditation from the Department.
(1) Primary accreditation. Out-of-State environmental laboratories may apply to the Department for primary accreditation under this chapter.
(2) Secondary accreditation.
(i) The Department will recognize accreditation granted by a primary NELAP accrediting authority for the same fields of accreditation for which the Department is a primary NELAP accrediting authority.
(ii) The Department may recognize the accreditation of an environmental laboratory by another state accrediting authority if the standards for accreditation are substantially equivalent to those established under this chapter and the laboratory is physically located within the state granting accreditation.
(iii) An environmental laboratory seeking secondary accreditation from the Department shall:
(A) Submit a properly completed application on forms provided by the Department.
(B) Pay the appropriate fee.
(C) Submit a copy of a valid accreditation certificate from the primary accrediting authority.
(D) Submit a copy of all onsite assessment reports conducted by the primary accrediting authority within the last 3 years.
(E) Submit copies of all proficiency test sample results reported to the primary accrediting authority within the past 12 months.
(F) Submit any other material relevant to accreditation, upon request of the Department.
(b) The Department may conduct an onsite assessment or require analysis of a proficiency test study by an out-of-State environmental laboratory seeking secondary accreditation for reasons which may include addressing complaints from the public, requests from Department personnel, discrepancies with environmental sample results, onsite assessment deficiencies, frequent errors in reporting data to the Department and suspicions of fraud regarding data quality. If the Department determines that an onsite assessment is required, the environmental laboratory shall pay the Department's travel costs associated with the onsite assessment in accordance with § 252.206 (relating to out-of-State onsite reimbursement).
(c) If any portion of the out-of-State environmental laboratory's accreditation is denied, revoked or suspended by the primary accrediting authority, the laboratory's authorization to perform testing or analysis is automatically revoked for the same fields of accreditation.
§ 252.206. Out-of-State onsite reimbursement.
In addition to the nonrefundable application fee, an out-of-State environmental laboratory shall reimburse the Department for the following costs associated with onsite assessments necessitated by accreditation:
(1) Transportation costs, including airfare, mileage, tolls, car rental, public transportation and parking.
(2) Meals and lodging.
(3) Travel time for each assessor at a rate of $50/hour.
(4) The fee imposed under subsection (c) will be increased every 3 years beginning January 1, 2009. The initial fee increase will be by the percentage, if any, by which the Consumer Price Index for the calendar year 2008 exceeds the Consumer Price Index for the calendar year 2005. Subsequent fee increases will be by the percentage, if any, by which the Consumer Price Index for the current calendar year exceeds the Consumer Price Index for the calendar year of the previous fee increase. For the purposes of this subsection:
(i) The Consumer Price Index for any calendar year is the average of the Consumer Price Index for All-Urban Consumers, published by the United States Department of Labor, as of the close of the 12 month period ending on June 30.
(ii) The revision of the Consumer Price Index that is most consistent with the Consumer Price Index for calendar year 2005 will be used.
(iii) The Department will publish the revised fee table in the Pennsylvania Bulletin at least 90 days prior to the effective date of the revision.
Subchapter C. GENERAL STANDARDS FOR ACCREDITATION Sec.
252.301. Laboratory supervisor. 252.302. Qualifications of the laboratory supervisor. 252.303. Grandfathering provisions for laboratory supervisors. 252.304. Personnel requirements. 252.305. Physical facilities. 252.306. Equipment, supplies and reference materials. 252.307. Methodology. § 252.301. Laboratory supervisor.
(a) Testing, analysis and reporting of data by an environmental laboratory shall be under the direct supervision of a laboratory supervisor.
(b) The laboratory supervisor shall certify that each test or analysis is accurate and valid and the test or analysis was performed in accordance with all conditions of accreditation.
(c) The Department may disqualify a laboratory supervisor who is responsible for the submission of inaccurate test or analysis results.
(d) The Department will disqualify a laboratory supervisor convicted of any crime or offense related to violations of State or Federal laws or regulations related to the provision of environmental laboratory services or reimbursement for the services.
(e) An environmental laboratory may appoint one or more laboratory supervisors for the appropriate fields of accreditation for which they are seeking accreditation.
(f) An environmental laboratory shall designate another staff member meeting the qualifications of a laboratory supervisor to temporarily perform this function when a laboratory supervisor is absent for a period of time exceeding 15 consecutive calendar days. If this absence exceeds 30 consecutive calendar days, the environmental laboratory shall notify the Department in writing under § 252.709 (relating to reporting and notification requirements).
(g) An individual may not be the laboratory supervisor of more than one environmental laboratory without authorization from the Department. Circumstances to be considered in the decision to grant the authorization will include at least the following:
(1) The extent to which operating hours of the laboratories to be supervised overlap.
(2) The adequacy of supervision in each laboratory.
§ 252.302. Qualifications of the laboratory supervisor.
(a) A laboratory supervisor of an environmental laboratory engaged in chemical analysis shall have the following qualifications:
(1) A bachelor's degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering.
(2) At least 24-college semester credit hours in chemistry.
(3) At least 2 years of experience in the testing or analysis of environmental samples in representative inorganic and organic fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation. An earned master's or doctoral degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering may be substituted for 1 year of experience.
(b) A laboratory supervisor of an environmental laboratory limited to the basic nonpotable water category or the basic drinking water category, shall have the following qualifications:
(1) At least 16-college semester credit hours in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering.
(2) At least 2 years of experience in the testing or analysis of environmental samples in representative fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation.
(c) A laboratory supervisor of an environmental laboratory limited to inorganic chemical analysis, other than metals analysis, shall have the following qualifications:
(1) At least an earned associate's degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering, or 2 years of equivalent and successful college education.
(2) At least 16-college semester credit hours in chemistry.
(3) At least 2 years of experience in the testing or analysis of environmental samples in representative fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation.
(d) A laboratory supervisor of an environmental laboratory engaged in microbiological or biological analysis shall have the following qualifications:
(1) A bachelor's degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering.
(2) At least 16-college semester credit hours in general microbiology and biology.
(3) At least 2 years of experience in the testing or analysis of environmental samples in representative microbiological or biological fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation. A master's or doctoral degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering may be substituted for 1 year of experience.
(e) A laboratory supervisor of an environmental laboratory engaged in microbiological analysis limited to fecal coliform, total coliform and heterotropic bacteria shall have the following qualifications:
(1) At least an associate's degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering.
(2) A minimum of 4-college semester credit hours in general microbiology.
(3) At least 2 years of equivalent and successful college education, including a minimum of 4-college semester credit hours in general microbiology, may be substituted for the associate's degree.
(4) At least 2 years of experience in the testing or analysis of environmental samples in representative fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation.
(f) A laboratory supervisor of an environmental laboratory engaged in radiological analysis shall have the following qualifications:
(1) A bachelor's degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering.
(2) At least 24-college semester credit hours in chemistry.
(3) At least 2 years of experience in the testing or analysis of environmental samples in representative radiological fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation. An earned master's or doctoral degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering may be substituted for 1 year of experience.
(g) A laboratory supervisor of an environmental laboratory engaged in microscopic examination of asbestos or airborne fibers shall have the following qualifications:
(1) For procedures requiring the use of a transmission electron microscope, a bachelor's degree, successful completion of formal course work in the use of the instrument, and 1 year of experience, under supervision, in the use of the instrument. The experience must include the identification of minerals.
(2) For procedures requiring the use of a polarized light microscope, an associate's degree or 2 years of college study, successful completion of formal coursework in polarized light microscopy, and 1 year of experience, under supervision, in the use of the instrument. The experience must include the identification of minerals.
(3) For procedures requiring the use of a phase contrast microscope, an associate's degree or 1 year of college study, documentation of successful completion of formal coursework in phase contrast microscopy, and 1 year of experience, under supervision, in the use of the instrument.
(h) Notwithstanding any other provision of this section, an employee of a drinking water, wastewater or industrial waste treatment facility meeting the following requirements will be deemed qualified as a laboratory supervisor of an environmental laboratory:
(1) The employee holds a valid treatment plant operator's certificate under the Water and Wastewater Systems Operators' Certification Act (63 P. S. §§ 1001--1015.1) in the appropriate water or wastewater subclassification for the facility.
(2) The employee holds a valid certificate under the Water and Wastewater Systems Operators' Certification Act for laboratory supervisor in the appropriate water or wastewater subclassification.
(3) Until 12 months after a certificate under the Water and Wastewater Systems Operators' Certification Act for laboratory supervisor in the appropriate water or wastewater subclassification becomes available from the Department, 2 years of experience performing testing or analysis of environmental samples using the methods and procedures currently in use by the environmental laboratory may be substituted for a laboratory supervisory certificate.
(i) Approval as a laboratory supervisor under subsection (h) will be limited to the fields of accreditation required by the scope of that facility's regulatory permit.
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