PRINTER'S NO. 2694
No. 2044 Session of 2001
INTRODUCED BY ROSS, HERSHEY, CLARK, CREIGHTON, DeWEESE, FRANKEL, GEORGE, HERMAN, JAMES, JOSEPHS, MANN, McGILL, MELIO, R. MILLER, S. MILLER, RUBLEY, SATHER, SCRIMENTI, R. STEVENSON, E. Z. TAYLOR, TIGUE, VANCE, WANSACZ, WATSON, WOJNAROSKI, BELFANTI, MUNDY AND YOUNGBLOOD, OCTOBER 17, 2001
REFERRED TO COMMITTEE ON ENVIRONMENTAL RESOURCES AND ENERGY, OCTOBER 17, 2001
AN ACT 1 Establishing within the Department of Environmental Protection 2 an accreditation program for environmental laboratories. 3 TABLE OF CONTENTS 4 Section 1. Short title. 5 Section 2. Definitions. 6 Section 3. Establishment of program. 7 Section 4. Powers and duties. 8 Section 5. Powers and duties of Environmental Quality Board. 9 Section 6. Requirements of certificate of accreditation. 10 Section 7. Interim requirements. 11 Section 8. Advisory committee. 12 Section 9. Unlawful conduct. 13 Section 10. Penalties. 14 Section 11. Records. 15 Section 12. Continuation of existing rules and regulations. 16 Section 13. Repeals.
1 Section 14. Effective date. 2 The General Assembly of the Commonwealth of Pennsylvania 3 hereby enacts as follows: 4 Section 1. Short title. 5 This act shall be known and may be cited as the Environmental 6 Laboratory Accreditation Act. 7 Section 2. Definitions. 8 The following words and phrases when used in this act shall 9 have the meanings given to them in this section unless the 10 context clearly indicates otherwise: 11 "Accreditation." A determination by the Department of 12 Environmental Protection that an environmental laboratory is 13 capable of performing one or more classes of testing or analysis 14 of environmental samples in accordance with this act. 15 "Certificate of accreditation." A document issued by the 16 Department of Environmental Protection certifying that an 17 environmental laboratory has met standards for accreditation. 18 "Department." The Department of Environmental Protection of 19 the Commonwealth. 20 "Environmental Hearing Board." The board established under 21 the act of July 13, 1988 (P.L.530, No.94), known as the 22 Environmental Hearing Board Act. 23 "Environmental laboratory." A facility engaged in the 24 testing or analysis of environmental samples. 25 "Environmental Quality Board." The board established under 26 section 1920-A of the act of April 9, 1929 (P.L.177, No.175), 27 known as The Administrative Code of 1929. 28 "Environmental sample." A solid, liquid, gas or other 29 specimen taken for the purpose of testing or analysis as 30 required by an environmental statute. 20010H2044B2694 - 2 -
1 "Environmental statute." A statute administered by the 2 Department of Environmental Protection relating to the 3 protection of the environment or of public health, safety and 4 welfare. 5 "Laboratory supervisor." A technical supervisor of an 6 environmental laboratory who supervises laboratory procedures 7 and reporting of analytical data. 8 "NELAC." The National Environmental Laboratory Accreditation 9 Conference. 10 "NELAP." The National Environmental Laboratory Accreditation 11 Program. 12 Section 3. Establishment of program. 13 (a) Establishment.--The department shall establish an 14 accreditation program for environmental laboratories. 15 (b) Accreditation.--An environmental laboratory must be 16 accredited under this act and be in compliance with all the 17 provisions of this act in order to generate data or perform 18 analyses to be used to comply with an environmental statute. 19 (c) Testing and analysis.--All testing and analysis 20 requirements of an environmental statute shall be performed by 21 an environmental laboratory accredited under this act. Testing 22 and analysis shall be performed in accordance with the 23 requirements of this act, the environmental statutes and any 24 conditions imposed by the department. 25 Section 4. Powers and duties. 26 The department shall have the following powers and duties: 27 (1) Establish, administer and enforce an environmental 28 laboratory accreditation program which shall include 29 accreditation standards necessary for a State certification 30 program. It shall also include a NELAP accreditation program 20010H2044B2694 - 3 -
1 for those laboratories seeking this certification. It may 2 also include any other specific or broad-based Federal or 3 State accreditation program for certification. 4 (2) Issue, renew, deny, revoke, suspend or modify 5 certificates of accreditation to environmental laboratories 6 in accordance with regulations adopted by the Environmental 7 Quality Board. 8 (3) Impose terms or conditions on accreditation as 9 necessary to implement and enforce this act. 10 (4) Conduct inspections and tests or samplings, 11 including the examination and copying of records and data 12 pertinent to a matter under investigation. Duly authorized 13 agents and employees of the department may, at reasonable 14 times, enter and examine property, facilities, operations and 15 activities subject to regulation under this act. 16 (5) Issue orders and initiate proceedings as necessary 17 to implement and enforce this act. 18 (6) Require a fee for the processing of an application 19 for a certificate of accreditation, including the issuance, 20 renewal, modification or other action relating to the 21 certificate in an amount sufficient to pay the department's 22 cost of implementation of the accreditation program. 23 (7) Provide technical assistance and advice to persons 24 and environmental laboratories subject to this act. 25 (8) Contract with third parties to inspect and monitor 26 environmental laboratories. 27 (9) Cooperate with appropriate Federal, State, 28 interstate and local government units and private 29 organizations to implement this act. 30 (10) Allow the use of experimental procedures, on a 20010H2044B2694 - 4 -
1 case-by-case basis, to satisfy the testing or analysis 2 requirements established under an environmental statute. 3 (11) Seek approval as an accrediting authority from 4 NELAP. 5 Section 5. Powers and duties of Environmental Quality Board. 6 (a) General rule.--The Environmental Quality Board shall 7 adopt regulations as necessary to implement this act, to include 8 the establishment of: 9 (1) Testing or analysis to be conducted by an 10 environmental laboratory. 11 (2) Allowable fees for environmental laboratories. 12 (3) Requirements for education, training and experience 13 of laboratory supervisors. 14 (4) Criteria and procedures to be used by the department 15 to accredit environmental laboratories, which may include 16 proficiency test samples and onsite audits. 17 (b) Accreditation.--An environmental laboratory shall be 18 accredited pursuant to this act and in compliance with the 19 provisions of this act in order to generate the data and perform 20 analysis to be used to comply with an environmental statute. 21 (c) General certificate program.--The Environmental Quality 22 Board may adopt regulations that establish a general certificate 23 of accreditation program or certificates of accreditation-by- 24 rule. 25 (d) Unique needs.--To the extent possible, the Environmental 26 Quality Board shall establish requirements and procedures that 27 address the unique needs of small businesses, municipalities and 28 municipal authorities. 29 Section 6. Requirements of certificate of accreditation. 30 (a) Forms.--Applications, certificates and other documents 20010H2044B2694 - 5 -
1 shall be in a form prescribed by the department. 2 (b) General requirements.--An environmental laboratory shall 3 have the staff, management structure, equipment, quality 4 assurance and quality control procedures and recordkeeping 5 procedures necessary to ensure that the environmental laboratory 6 generates valid and accurate test results in accordance with all 7 conditions of accreditation and this act. 8 (c) Laboratory supervisor.--Testing, analysis and reporting 9 of data by an accredited laboratory shall be under the direct 10 supervision of a laboratory supervisor. The laboratory 11 supervisor shall certify that each test or analysis is accurate 12 and valid and that the test or analysis was performed in 13 accordance with all conditions of accreditation. The department 14 may disqualify a laboratory supervisor who is responsible for 15 the submission of inaccurate test or analysis results. 16 (d) Access to records and data.--An accredited laboratory 17 shall provide the department with access to inspect records and 18 data maintained under this act and to conduct tests and sampling 19 related to inspections. 20 Section 7. Interim requirements. 21 (a) Registration.--All environmental laboratories shall 22 register with the department within six months of the effective 23 date of this act, on a registration form prepared by the 24 department. An environmental laboratory which begins operations 25 in this Commonwealth after this date shall register with the 26 department before beginning operations. 27 (b) Time for application.--An environmental laboratory shall 28 apply for accreditation within six months after the 29 Environmental Quality Board establishes an accreditation 30 requirement by regulation for a type of laboratory. The 20010H2044B2694 - 6 -
1 submission of an application shall provide interim authorization 2 to continue operations until the department takes final action 3 on the application. 4 (c) NELAP accreditation.--An environmental laboratory may 5 apply to the department for NELAP accreditation after the 6 department is approved as an accrediting authority by NELAP. The 7 department may grant NELAP accreditation to a laboratory that 8 meets the requirements of this act and the most current version 9 of the NELAC standards that are hereby incorporated by 10 reference. 11 (d) Temporary fees.--Until regulations are promulgated under 12 this act, the following fees shall be charged: 13 (1) Five thousand dollars for the processing of an 14 application for NELAP accreditation. 15 (2) Fifty dollars for the processing of an application 16 for registration. 17 Section 8. Advisory committee. 18 The department shall appoint a Laboratory Accreditation 19 Advisory Committee to provide technical assistance under this 20 act. The committee shall consist of 11 members, including the 21 following: 22 (1) One representative of a municipal authority. 23 (2) One representative from a commercial environmental 24 laboratory. 25 (3) One representative from an industrial environmental 26 laboratory. 27 (4) One representative from an academic laboratory. 28 (5) One representative from a small environmental 29 laboratory. 30 (6) One environmental engineer. 20010H2044B2694 - 7 -
1 (7) One member of an association of community water 2 supply systems. 3 (8) One member of an association of wastewater systems. 4 (9) One member with technical expertise in the testing 5 and analysis of environmental samples. 6 (10) Two members of the general public. 7 Section 9. Unlawful conduct. 8 (a) General rule--It shall be unlawful for a person to 9 violate or to cause or assist in the violation of this act, to 10 fail to comply with an order or condition of accreditation 11 within the time specified by the department or to hinder, 12 obstruct, prevent or interfere with the department in the 13 performance of its duties under this act. 14 (b) Refusal of accreditation.--The department may refuse to 15 issue a certificate of accreditation to an environmental 16 laboratory which has demonstrated a lack of intention or ability 17 to comply with this act or engaged in unlawful conduct or which 18 has an employee, officer, contractor, agent or other person set 19 forth in regulation who has engaged in unlawful activity under 20 this act unless the applicant demonstrates to the satisfaction 21 of the department that the unlawful conduct is being or has been 22 corrected. 23 (c) Denial of access.--It shall be unlawful for an 24 accredited laboratory or other person subject to regulation 25 under this act to deny the department access to make inspections 26 and conduct tests or sampling, including the examination and 27 copying of books, papers, records and data pertinent to any 28 matter under investigation pursuant to this act. Failure to 29 provide the department with access shall result in the immediate 30 suspension of any accreditation of the laboratory. Upon notice 20010H2044B2694 - 8 -
1 from the department, the laboratory shall immediately cease 2 testing or analysis of environmental samples. The department may 3 revoke an accreditation for failure to provide the department 4 with access to make inspections and conduct tests or sampling, 5 including the examination and copying of books, papers, records 6 and data pertinent to any matter under investigation pursuant to 7 this act. 8 (d) Notice.--The environmental laboratory shall notify each 9 of its customers in writing within 72 hours of receipt of the 10 department's notice if the department suspends or revokes in 11 whole or in part a certificate of accreditation. The notice 12 shall be on a form and in a manner approved by the department. 13 Section 10. Penalties. 14 (a) Criminal penalties.-- 15 (1) A person who knowingly, willfully or recklessly 16 misrepresents that a test or an environmental sample is 17 accurate or was performed in accordance with procedures 18 authorized pursuant to this act commits a misdemeanor of the 19 third degree and, upon conviction, shall be subject to a fine 20 of not less than $1,250 nor more than $12,500 or to 21 imprisonment for a period of not more than one year, or both, 22 for each separate offense. 23 (2) A person who knowingly, willfully or recklessly 24 performs or reports an inaccurate test or analysis of an 25 environmental sample commits a misdemeanor of the third 26 degree and, upon conviction, shall be subject to a fine of 27 not less than $1,250 nor more than $12,500, or to 28 imprisonment for a period of not more than one year, or both, 29 for each separate offense. 30 (3) A person who knowingly, willfully or recklessly 20010H2044B2694 - 9 -
1 misrepresents that an environmental laboratory holds a 2 certificate of accreditation under this act commits a 3 misdemeanor of the third degree and, upon conviction, shall 4 be subject to a fine of not less than $1,250 nor more than 5 $12,500, or to imprisonment for a period of not more than one 6 year, or both, for each separate offense. 7 (b) Administrative penalties.-- 8 (1) In addition to any other remedy available at law or 9 equity, the department may assess an administrative penalty 10 for a violation of this act. The penalty may be assessed 11 whether or not the violation was willful or negligent. When 12 determining the amount of the penalty, the department shall 13 consider the willfulness of the violation, the damage or 14 injury, or threat of damage or injury, to public health or 15 the environment, the costs to the department for 16 investigation and enforcement, the economic benefit of the 17 violation to the person and other related factors. The 18 department shall inform the person of the amount of the 19 penalty. The administrative penalty shall not exceed $5,000 20 per day per violation. 21 (2) Every day a violation continues shall be a separate 22 violation. 23 (3) The amount of the penalty assessed after a hearing 24 before the Environmental Hearing Board, or after waiver of 25 the right to appeal the assessment, shall be payable to the 26 Commonwealth and collectable in any manner provided at law 27 for collection of debts. If any person liable to pay any such 28 penalty neglects or refuses to pay the penalty after demand, 29 the amount of the penalty, together with interest and cost 30 that may accrue, shall constitute a judgment in favor of the 20010H2044B2694 - 10 -
1 department upon the property of such person from the date it 2 has been entered and docketed of record by the prothonotary 3 of the county in which the property is situated. The 4 department may, at any time, transmit to the prothonotaries 5 of any county in which the person holds property, certified 6 copies of all such judgments, and it shall be the duty of 7 each prothonotary to enter and docket the judgment of record 8 in his or her office and to index the judgment as judgments 9 are indexed, without requiring the payment of costs by the 10 department. 11 (c) Concurrent penalties.--Penalties and other remedies 12 under this act shall be concurrent and shall not prevent the 13 department from exercising any other available remedy at law or 14 equity. 15 (d) Rebuttable presumption.--Failure of an environmental 16 laboratory or laboratory supervisor to maintain adequate records 17 or proficiency test samples as required creates a rebuttable 18 presumption that the test or analysis was not conducted as 19 required. 20 (e) Falsifying results.--It shall be unlawful to falsify the 21 results of testing or analysis of environmental samples or to 22 violate the provisions of 18 Pa.C.S. § 4903 (relating to false 23 swearing) or 4904 (relating to unsworn falsification to 24 authorities) in the context of the submission of the results of 25 testing and analysis of environmental samples under an 26 environmental statute. 27 Section 11. Records. 28 Records required under this act shall be maintained for five 29 years unless otherwise specified in regulation. 30 Section 12. Continuation of existing rules and regulations. 20010H2044B2694 - 11 -
1 All existing rules and regulations promulgated pursuant to 2 any environmental statute remain in full force and effect until 3 superseded and repealed by the rules and regulations promulgated 4 pursuant to this act. 5 Section 13. Repeals. 6 All acts and parts of acts are repealed insofar as they are 7 inconsistent with this act. 8 Section 14. Effective date. 9 This act shall take effect immediately. J15L27RLE/20010H2044B2694 - 12 -