RULES AND REGULATIONS
Title 25--ENVIRONMENTAL PROTECTION
ENVIRONMENTAL QUALITY BOARD
[25 PA. CODE CHS. 78, 109 AND 252]
Oil and Gas Wells, Safe Drinking Water and Environmental Laboratory Accreditation
[36 Pa.B. 465] The Environmental Quality Board (Board) amends Chapters 78 and 109 (relating to oil and gas wells; and safe drinking water) and adds Chapter 252 (relating to environmental laboratory accreditation). This final-form rulemaking delineates and consolidates the requirements for accreditation of environmental laboratories in Chapter 252.
This order was adopted by the Board at its meeting of August 16, 2005.
A. Effective Date
This final-form rulemaking will go into effect upon publication in the Pennsylvania Bulletin.
B. Contact Persons
For further information contact Richard H. Sheibley, Chief, Laboratory Accreditation Program, P. O. Box 1467, 2575 Interstate Drive, Harrisburg, PA 17105-1467, (717) 346-8215; or Scott Perry, Assistant Counsel, Bureau of Regulatory Counsel, P. O. Box 8464, Rachel Carson State Office Building, Harrisburg, PA 17105-8464, (717) 787-7060. Persons with a disability may use the AT&T Relay Service, (800) 654-5984 (TDD users) or (800) 654-5988 (voice users). This final-form rulemaking is available on the Department of Environmental Protection's (Department) website: www.dep.state.pa.us.
C. Statutory Authority
This final-form rulemaking is being made under the authority of 27 Pa.C.S. § 4103(a) (relating to establishment of program), which directs the Department to establish an accreditation program for environmental laboratories, 27 Pa.C.S. § 4104 (relating to powers and duties), which directs the Department to establish, administer and enforce an environmental laboratory accreditation program which shall include the standards necessary for a State certification program, 27 Pa.C.S. § 4105 (relating to powers and duties of Environmental Quality Board), delegating the Board the power to adopt the regulations of the Department to implement 27 Pa.C.S. §§ 4101--4113 (act) (relating to environmental laboratory accreditation), and section 1920-A of The Administrative Code of 1929 (71 P. S. § 510-20), authorizing and directing the Board to adopt regulations necessary for the proper performance of the work of the Department.
D. Background of the Final-Form Rulemaking
Over the past 25 years, the General Assembly and the United States Congress have enacted numerous statutes protecting air, water and soil and regulating activities that might otherwise pose a threat to the environment. Valid and accurate laboratory data are essential to assure compliance with the laws administered by the Department. Additionally, throughout this Commonwealth numerous decisions made everyday by the public, the regulated community and the government are based upon data generated by environmental laboratories. Recently however, several highly publicized instances of laboratory fraud or reliance on faulty data have undermined the public's confidence in the data generated by environmental laboratories. Presently, in this Commonwealth only the Drinking Water Program and the Oil and Gas Program address the issue of data quality through a laboratory accreditation program. The quality of laboratory data used to determine compliance with the remaining Department regulations is unknown. Without these regulations, verification of the accuracy of data submitted to the Department is a very costly and time-consuming task.
The goal of this final-form rulemaking is to assure the quality of the data used to make environmental decisions and thus better protect the environment and the health, safety and welfare of the citizens of this Commonwealth. This goal is achieved by requiring affected environmental laboratories to perform proficiency test (PT) samples, data verification requirements and undergo periodic onsite inspections where the Department evaluates laboratory procedures in place in that facility. The final-form rulemaking includes only items that are essential for the production of good quality data.
This final-form rulemaking applies to environmental laboratories that test or analyze nonpotable water (wastewater), solid and chemical materials or drinking water samples as required by the following 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 Conservation Act (52 P. S. §§ 1406.1--1406.21).
12. The Noncoal Surface Mining Conservation and Reclamation Act (52 P. S. §§ 3001--3326).
This final-form rulemaking transfers the laboratory accreditation program, currently under the Safe Drinking Water Program (Chapter 109), to Chapter 252. The Safe Drinking Water Act (42 U.S.C.A. §§ 300f--300j-10) requires that laboratories performing drinking water analysis be accredited. Additionally, this final-form rulemaking transfers the laboratory accreditation program, currently under the Oil and Gas Program (Chapter 78), to Chapter 252. The Federal drinking water laboratory accreditation program consists of requiring the use of promulgated methods for testing and analysis and recommending good laboratory practices, including the use of appropriate quality control measures. There are no Federal standards for accreditation of an environmental laboratory testing nonpotable water (wastewater) and solid and chemical materials.
The National Environmental Laboratory Accreditation Conference (NELAC) developed a set of standards for the accreditation of environmental laboratories performing testing and analysis of environmental samples. At the time the current NELAC Standard was being developed, NELAC was a voluntary organization of state and Federal environmental officials and interest groups. NELAC's primary mission was to establish mutually acceptable standards for accrediting environmental laboratories. The NELAC Standard provides uniform requirements for accreditation of environmental laboratories and facilitates mutual recognition among laboratory accreditation programs using the NELAC Standard. The NELAC Standard was developed using a consensus-based approach. The Department would offer a dual accreditation system whereby accreditation to the NELAC Standard is available as a voluntary option for environmental laboratories.
At the request of small laboratories, the requirements in this final-form rulemaking for State environmental laboratory accreditation are less stringent than the NELAC Standard. Currently, a relatively small number of accredited laboratories in this Commonwealth are accredited to the NELAC Standard. The costs associated with complying with the NELAC Standard are higher than those anticipated with this final-form rulemaking. To meet the requirements in the NELAC Standard, an environmental laboratory is required to participate in at least double the number of PT studies. The cost of the PT studies varies widely depending on the laboratory's scope of accreditation. The cost ranges from $88 for a single microbiology PT to approximately $13,000 to acquire PT samples for the entire scope of PT samples available for accreditation. An environmental laboratory accredited to the NELAC Standard must implement a very rigorous quality system that requires highly specific documentation and quality assurance procedures.
The final-form rulemaking is very comparable in terms of the range and stringency of requirements to other state (non-NELAC based) laboratory accreditation programs for drinking water, wastewater and solid and chemical materials. A survey of 40 other states indicated that at least 22 states have mandatory accreditation programs for environmental laboratories testing wastewater and solid and chemical materials.
An environmental laboratory may choose State accreditation, described by this final-form rulemaking, or seek accreditation using the NELAC Standard as a voluntary alternative to this final-form rulemaking. Accreditation to either set of standards would be equivalent and acceptable and meet the requirements for accreditation required by the act. An environmental laboratory may be accredited to the NELAC Standard and also be accredited under Pennsylvania accreditation standards in this final-form rulemaking for fields of accreditation not included under the NELAC Standard.
The Laboratory Accreditation Advisory Committee (LAAC) provided technical assistance throughout the development of this final-form rulemaking. The LAAC met approximately every other month from August 2002 through April 2004 and advised the Department on the development of proposed Chapter 252. Additionally, the LAAC and the Certification Program Advisory Committee (CPAC) met jointly on January 23, 2004, to discuss and provide recommendations on several key concepts (fee structure, qualifications of a laboratory supervisor and parameters to be included in accreditation-by-rule).
The LAAC reviewed the draft final-form rulemaking on June 1, 2005, and unanimously supported moving the draft rulemaking forward to the Board.
To the extent possible, the unique needs of small businesses, municipalities, municipal authorities and in-house laboratories (collectively referred to as small laboratories) have been considered and addressed throughout this final-form rulemaking when compatible with the goals of creating an effective and sensible environmental laboratory accreditation program. Specific provisions that address these unique needs include: an accreditation-by-rule section addressing the testing and analyses conducted by many of the smallest laboratories; laboratory supervisor qualifications tailored to the complexity of the analysis; provisions concerning certified operators and experienced supervisors; and a fee structure that addresses the needs of laboratories that perform only a few types of tests.
A section outlining accreditation-by-rule is included in Chapter 252 to specifically address the unique needs of small laboratories. Accreditation-by-rule is a mechanism permitting an environmental laboratory to perform testing or analysis with only minimal oversight by the Department. Therefore, only certain tests or analyses are appropriate for inclusion under accreditation-by-rule.
The final-form accreditation-by-rule section continues the exemptions provided in the current Drinking Water Program regulations under §§ 109.304(c) and 109.704 (relating to analytical requirements; and operator certification). Reference is made in this final-form rulemaking to the Chapter 109 drinking water regulations. Because of the significance of these parameters in assessing environmental quality and because of the technical skills necessary to perform these tests correctly, total residue testing, biochemical oxygen demand testing and fecal coliform testing are not included under accreditation-by-rule.
Consistent with the requirements of the act, the final-form rulemaking establishes qualifications for laboratory supervisors. The laboratory supervisor may have different titles in different laboratories, such as lead analyst or technical director. The act identifies a laboratory supervisor as the individual who supervises laboratory procedures and reporting of analytical data. Specific educational qualifications are not established for other technical personnel or analysts in the laboratory. The unique needs of small laboratories are addressed by basing the laboratory supervisor requirements upon the testing or analysis performed in the laboratory. A person who is functioning as a laboratory supervisor now would be able to continue in that position under the grandfathering provisions as provided in § 252.303 (relating to grandfathering provisions for laboratory supervisors).
The final-form rulemaking also recognizes that a drinking water or wastewater operator with a valid treatment plant operator's certificate for laboratory supervisor in the appropriate water or wastewater subclassification would qualify as a laboratory supervisor. To provide a smooth transition during the period when the laboratory supervisor subclassification may not be available, a contingency provision is included in the final-form rulemaking. The final-form rulemaking provides that for the period up to 12 months after a certificate 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.
All laboratory supervisors will be required to have experience in the areas for which they will be responsible. In addition, minimum levels of college credits in basic science are identified for laboratory supervisors, when appropriate. Consistent with the requirements of the act, the final-form rulemaking identifies the responsibilities of a laboratory supervisor. The final-form rulemaking provides that a person may be a supervisor of more than one laboratory under certain conditions.
E. Summary of Changes to the Proposed Rulemaking
Chapter 78
Subchapter A. General Provisions
The definition for ''certified laboratory'' in § 78.1 (relating to definitions) was changed to ''accredited laboratory'' and revised to refer to Chapter 252 instead of Subchapter F.
Subchapter C. Environmental Protection Performance Standards
In § 78.52(c) (relating to predrilling or prealteration survey), ''certified laboratory'' was changed to ''accredited laboratory'' and the text was revised to refer to Chapter 252 instead of Subchapter F
Subchapter F
Subchapter F was rescinded.
Chapter 109
Subchapter H. Laboratory Certification
In §§ 109.801 and 109.810(a) and (b) (relating to certification requirement; and reporting and notification requirements), ''certified laboratory'' was changed to ''accredited laboratory'' and the text was revised to refer to Chapter 252.
Sections 109.802--109.809 were rescinded.
Subsections (c)--(e) were deleted from § 109.810.
Chapter 252
Subchapter A. General Provisions
Clarifying language was added to the definitions of ''laboratory notebook,'' ''matrix spike'' and ''method blank'' in § 252.1 (relating to definitions). The word ''analytical'' was added to the definition of ''laboratory supervisor'' to be consistent with the definition in the act. Definitions were added for ''spike'' and ''surrogate'' and the definition of ''relative standard deviation'' was deleted.
The reference to The Bituminous Mine Subsidence and Land Conservation Act in § 252.3 (relating to scope) was corrected.
Clarifying language was added to § 252.4 (relating to general requirements) regarding the provision for interim accreditation for laboratories that apply during the 6 months immediately following the effective date of the final-form rulemaking.
Subsections (c) and (d) of § 252.5 (relating to NELAP equivalency) were reordered for clarity.
Subsections (a)(1) and (2), (c) and (f) of § 252.6 (relating to accreditation-by-rule) were revised for clarity and ''sludge'' was added to subsection (f)(25) for completeness.
Subchapter B. Application, Fees and Supporting Documents
Section 252.203(b) (relating to accreditation renewal) was added for clarity.
The fee structure in § 252.204 (relating to fees) was revised by differentiating between renewal of accreditation and an initial application. Eliminating the fee for each additional method and establishing category groups simplified the remaining categories. The provision linking fee increases to the Consumer Price Index was eliminated. However, the act requires the Department to establish fees in an amount sufficient to recover the Department's costs to implement and administer the accreditation program. Therefore, the Department will evaluate its costs to administer the accreditation program at least every 3 years and, if necessary, revise the accreditation fees through future rulemakings.
In response to a commentator, § 252.205(b) (relating to out-of-State laboratories) has been revised for additional clarity.
Section 252.206(4) (relating to out-of-State onsite reimbursement) was deleted.
Proposed § 252.701 was moved to Subchapter B and renumbered as § 252.207 (relating to expiration of application).
Subchapter C. General Standards for Accreditation
Clarifying language was added to § 252.301(b) (relating to laboratory supervisor) to provide additional detail on the meaning of ''certify.'' Subsection (c) was added to clarify the laboratory supervisor's responsibility for maintaining records. Also, an incorrect reference was corrected that was created by deletion of a paragraph in Subchapter G (relating to miscellaneous provisions).
Section 252.302(b) (relating to qualifications of the laboratory supervisor) was moved to immediately follow a related section on laboratory supervisor qualifications. Sections were renumbered appropriately.
Specific language was added to § 252.303 to indicate that the date an environmental laboratory becomes subject to accreditation is the effective date of this final-form rulemaking. Also, the final-form rulemaking was clarified to state that approval under the grandfathering provision will be limited to the current facility and may not be transferred to a different environmental laboratory.
The incorrect method reference in § 252.304(b)(3) (vii)(C) (relating to personnel requirements) was corrected. Section 252.304(4) and (8) was deleted because these paragraphs are redundant and not needed.
Section 252.306(f)(4)(ii) and (iii) (relating to equipment, supplies and reference materials) was combined for simplicity.
Clarifying language was added to § 252.307(b)(2) (relating to methodology). Additional details were added to § 252.307(c)(4) and (5).
Subchapter D. Quality Assurance and Quality Control Requirements
The general reference to ''guidance'' in § 252.403 (relating to essential quality control requirements--toxicity testing) was replaced with a reference to Chapter 16 (relating to water quality toxics management strategy--statement of policy).
Subchapter E. Proficiency Test Study Requirements
Section 252.501 (relating to proficiency test study requirements) was clarified to state that failure to successfully analyze a PT study only affects an individual field of accreditation.
Subchapter G. Miscellaneous Provisions
Proposed § 252.701 was moved to Subchapter B and renumbered as § 252.207 for readability. The remaining sections and internal reference numbers were renumbered accordingly. Several sections dealing with denial and revocation were clarified and simplified. Language clarifying the records an environmental laboratory is required to maintain was also added. Paragraphs in § 252.707 (relating to subcontracting) were reordered for clarity. Section 252.708 (relating to reporting and notification requirements) was simplified.
F. Summary of Comments and Responses on the Final-Form Rulemaking
Comments were received from 20 commentators, including the Independent Regulatory Review Commission (IRRC), the Chairpersons of the Senate Environmental Resources and Energy Committee and the House Environmental Resources and Energy Committee, as a result of the public comment period. None of the commentators opposed the technical requirements or merits of the rulemaking. Several commentators opposed linking the fee increases to the Consumer Price Index. Other commentators provided comments on the technical aspects of the rulemaking. Several commentators indicated that particular tests or types of environmental laboratories should be included under the accreditation-by-rule provision, effectively removing the suggested tests or analyses from the requirements of the proposed rulemaking.
Comments on the fees and fee structure from commentators and LAAC members indicated that the proposed fee structure was difficult to understand and that the fees favored (depending upon the commentator) large, mid-size or small laboratories. This clarity concern is addressed in this final-form rulemaking. The changes to the fee structure include: charging a fee per category per matrix, thus eliminating the individual method charges; different fees for an initial application fee and a renewal application fee; reducing the fees for both basic drinking water and nonpotable water categories; adding categories that are combinations of several categories; and removing the provision linking fee increases to the Consumer Price Index. In addition to improved clarity, all these changes make fee structure more responsive to the unique needs of small, in-house environmental laboratories.
Several comments were received about the accreditation-by-rule section or the definition of ''environmental laboratory.'' Most of these comments were requests for inclusion of specific tests or analysis under the accreditation-by-rule section or exclusion of a group of laboratories from the rulemaking entirely. Because of the significance of these parameters in assessing environmental quality and because of the technical skills necessary to perform these tests correctly, this final-form rulemaking was not changed and additional tests were not included under accreditation-by-rule. Differentiating between in-house and commercial laboratories is not appropriate. The purpose of this final-form rulemaking is to improve the quality of data for any testing or analysis of environmental samples that is required by the Department. Data from these tests are essential for making decisions that affect the environment and the public health, safety and welfare of the citizens of this Commonwealth. Additional tests should not be included under the accreditation-by-rule section. The location of the testing nor the firm or individual performing the testing should be the basis for inclusion under the final-form rulemaking.
Several commentators indicated that the rulemaking would discourage out-of-State laboratories from doing business in this Commonwealth or raise costs to businesses based in this Commonwealth. It is neither the Department's desire nor intent to discourage out-of-State laboratories from doing business in this Commonwealth. The act states that a laboratory meeting Pennsylvania accreditation standards may perform any required testing and analysis. Section 4104(1) of the act limits the recognition of other accreditation programs to Federal or State accreditation programs. Additionally, the NELAC Standard requires that an accrediting authority be a state or Federal agency. The proposed and final-form rulemakings conform to both the NELAC Standard and the act. The final-form rulemaking and the accreditation program are designed to assure that the tests and analyses are performed according to the minimum documentation, quality control and method requirements and that the laboratory's procedures have been reviewed to assure these requirements are being met. The Department does not believe that including a provision for a variance for out-of-State laboratories is consistent with the intent of the act.
Several commentators thought that the proposed rulemaking did not adequately address the unique needs of small businesses, municipalities, municipal authorities and in-house laboratories. The Department disagrees; specific provisions that address these unique needs include: an accreditation-by-rule section addressing the testing and analyses conducted by many of the smallest laboratories; laboratory supervisor qualifications tailored to the complexity of the analysis; provisions concerning certified operators and experienced supervisors; and a fee structure that addresses the needs of laboratories that perform only a few types of tests.
A description of comments received by section of the proposed rulemaking and the Department's response follows:
Scope: Several commentators requested additional clarification regarding testing that is required by the Clean Air Act (42 U.S.C.A. §§ 7401--7642) and the Air Pollution Control Act (35 P. S. §§ 4001--4015). The commentators requested specific exclusions for all sampling and monitoring of air emissions and air quality, including any sampling and analysis requirements covered by the Clean Air Act and Air Pollution Control Act, whether or not the air related requirements are referenced regulations or permits issued under environmental statutes listed in § 252.3(a).
Response: Because the final-form rulemaking lists only the specific statutes included in the scope of the regulations, the Department believes that this section is sufficiently clear. In contrast, specifically exempting the Clean Air Act or the Air Pollution Control Act would create confusion. The Department administers other statutes regarding the protection of the environment and the health, safety and welfare of the citizens of this Commonwealth that are not included within the scope of this final-form rulemaking. New statutes may be enacted that will be administered by the Department. Listing an exemption for only one or two specific statutes could lead to questions concerning the applicability of the final-form rulemaking to the other unlisted statutes. The Department believes that additional clarifying language is not necessary in the final-form rulemaking. Facilities that test environmental samples to comply with the Clean Air Act or the Air Pollution Control Act do not need to be accredited to perform these tests.
Two commentators requested additional clarification exempting industries that are subject to the Federal pretreatment standards.
Response: The final-form rulemaking is applicable to testing or analysis required by the Department. Testing performed to satisfy only Federal requirements is outside the scope of the act and could not be covered by the final-form rulemaking. Additional clarifying language is not necessary in the final-form rulemaking and might lead to confusion.
Definitions: Several commentators requested removal of terms that were defined but not used, clarification of existing terms, rewording of definitions to be consistent with the act and addition of new terms for clarity.
Response: The Department agreed with most of the comments and made appropriate changes to the final-form rulemaking. Additionally, the Department added clarifying language to other definitions. The Department did not agree to change the definition of ''environmental laboratory'' or ''environmental sample'' as the definitions used in the draft rulemaking and the final-form rulemaking are identical to the definition in the act.
Two commentators indicated that the meaning of ''direct supervision'' as used in § 252.301(a) is unclear.
Response: Section 4106(c) of the act (relating to requirements of certificate of accreditation) requires ''testing, analysis and reporting of data by an accredited laboratory shall be under the direct supervision of a laboratory supervisor.'' This section of the act provides additional detail for the responsibilities of the laboratory supervisor. Section 252.301 reflects these requirements. The laboratory supervisor is not required to be in the laboratory during all times that testing and analysis is being performed. A laboratory supervisor would be required to be available, be able to exercise appropriate control over the operations of the laboratory and be responsible for the accuracy and validity of the data provided by the laboratory. The requirements are described in section 4106(c) of the act and in Subchapter C, especially §§ 252.301 and 252.304. Should multiple environmental laboratories wish to use the same individual as the laboratory supervisor, each laboratory would need to demonstrate the adequacy of the supervision as required by § 252.301(g).
Two commentators requested addition of a definition for ''failure'' as it applies in § 252.501(k).
Response: The Department added clarifying language that indicates failure applies to each individual field of accreditation.
Interim accreditation and time of application for accreditation: Several commentators noted that the proposed rulemaking did not include a provision for interim accreditation or provide sufficient detail regarding the date an environmental laboratory would be subject to accreditation.
Response: The Department changed § 252.4 to reflect the requirements of section 4107 of the act (relating to interim requirements), which provides that a laboratory that submits an application within 6 months of the effective date of this final-form rulemaking will be granted interim authorization to continue operations until the Department takes a final action on the application. Additional language was added indicating that the effective date for environmental laboratories is the date of final-form publication in the Pennsylvania Bulletin.
Accreditation-by-rule: Several commentators requested inclusion of additional tests or analyses, including Biological Oxygen Demand and Total Suspended Solids, under the accreditation-by-rule section. Other commentators requested that specific types of environmental laboratories be included under the accreditation-by-rule section or exempted from the section. Several commentators requested more flexibility by allowing individual cases where the intent of the law is being followed. The commentators suggested adding an exemption for a variety of other reasons.
Response: Because of the significance of these parameters in assessing environmental quality and because of the technical skills necessary to perform these tests correctly, these tests were not included under accreditation-by-rule. The purpose of this final-form rulemaking is to improve the quality of data for any testing or analysis of environmental samples that is required by the Department. Because these data are essential for making decisions that affect the environment and the public health, safety and welfare of the citizens of this Commonwealth, the Department believes these tests should not be included under the accreditation-by-rule section.
Several commentators indicated that major National Pollutant Discharge Elimination System (NPDES) dischargers are already required to participate in the United States Environmental Protection Agency's (EPA) annual Discharge Monitoring Report-Quality Assurance (DMRQA) Study. As long as an in-house lab (one that only performs analyses for its own facility's permit requirements) successfully performs the analytical procedures under the DMRQA program, it should be deemed accredited-by-rule.
Response: Successful performance on one proficiency test sample per year (for example, a DMRQA Study) is only one indicator that a laboratory is producing good quality data. A more thorough evaluation is necessary to insure that a laboratory is producing adequate quality data and is in conformance with all of the requirements of the laboratory accreditation regulation, the promulgated method and all other applicable Federal and State regulations. The accreditation process includes other aspects of data evaluation and an onsite review of the laboratory, which include consideration of facilities, personnel, equipment, methodology, quality assurance, recordkeeping and performance.
Several commentators questioned the rationale for inclusion or exclusion of the analytical parameters under accreditation-by-rule.
Response: The preamble to the proposed rulemaking indicated that to be considered for accreditation-by-rule the test would need to meet one of the criteria listed in the preamble. The LAAC agreed to these criteria following an extensive discussion of the merits of the proposed items. Tests proposed for inclusion under accreditation-by-rule were then evaluated against these criteria, especially with regard to the impact that an improperly performed test would have on the environment or the public health, safety and welfare. Short holding times, sample degradation during transport and non- instrumented tests were factors for consideration for inclusion of a particular test or analysis under accreditation-by-rule provided that mistakes in testing would not necessarily result in a significant threat of harm to the environment. The Department, in conjunction with the LAAC, subsequently selected the accreditation-by-rule parameters included in the proposed rulemaking. The final-form rulemaking retains the original listing of parameters.
Two commentators indicated that § 252.6(d) states that the tests not mandated by Department statute are accredited-by-rule. The final-form rulemaking should not refer to tests and analysis not mandated by the Department. The scope of this final-form rulemaking is to regulate only those tests mandated by specific environmental statutes.
Response: Discussion with individuals, advisory committees and other groups affected by this final-form rulemaking indicated a need to clarify applicability of the final-form rulemaking to this type of testing. In particular, testing for certain parameters may not be required by the Department. However if a test is conducted, the results must be reported. Laboratories were concerned that they would be required to be accredited to perform these types of tests. Requests were made to emphasize this point in the final-form rulemaking. This section was added and is being retained for additional clarification.
Two commentators requested that the accreditation-by-rule section be expanded to include all analyses or tests that are required by State or Federal laws, regulations, an order or permit conditions.
Response: The Department strongly disagrees with the commentators, as the suggested exclusion would exempt in-house laboratories from accreditation requirements. The purpose of this final-form rulemaking is to improve the quality of data for any testing or analysis of environmental samples that is required by the Department. Because these data are essential for making decisions that affect the environment and the public health, safety and welfare of the citizens of this Commonwealth, accreditation of the facilities performing this type of testing is appropriate..
Mobile Laboratories: Two commentators indicated that requiring separate accreditation for mobile laboratories convolutes the field testing process. One commentator asked whether individual accreditations would be required if the same entity owned multiple mobile laboratories. A commentator asked about the acceptability of a single individual acting as the laboratory supervisor for multiple mobile laboratories.
Response: Each laboratory would be considered as a separate environmental laboratory and would be required to maintain separate accreditation. Separate accreditation is required because a mobile laboratory would be expected to be operated independently of an associated fixed facility and under a different quality manual and standard operating procedures (SOPs). A mobile laboratory would not be required to apply for accreditation for each site or testing location. Accreditation of a mobile laboratory would include any methods or procedures for which it has demonstrated compliance with the requirements of Chapter 252. Even though the mobile laboratories are owned or operated by the same entity, they may be performing testing and analysis at geographically separate locations. A single individual could serve as the laboratory supervisor for more than one mobile laboratory provided the requirements of § 252.301(g) are met. The Department does not think the regulation will be too burdensome for mobile laboratories.
Fees: Several commentators indicated that the fees were prohibitive and favored small, medium or large laboratories, depending upon the commentator. Several commentators indicated that the fee structure was difficult to understand or unnecessarily complex. Other suggested changes to the fee structure included charging a different fee for an initial and for a renewal application and basing the fee on the number of samples analyzed by the laboratory.
Response: After reviewing the comments regarding the fees and their structure, the Department reexamined the fee structure. As a result of some recently implemented and planned cost saving measures, including the use of newly developed database technology, the Department was able to make some changes to the fee structure. These changes include: charging a fee per category per matrix, thus eliminating the individual method charges; different fees for an initial application fee and a renewal application fee; reducing the fees for both basic drinking water and nonpotable water categories; and adding categories that are combinations of several categories. The changes make fees more responsive to the unique needs of small, in-house environmental laboratories.
The act requires that the fees be sufficient to pay the Department's cost of implementing and administering the accreditation program. See section 4104(6) of the act. Based upon the Department's experience with the drinking water laboratory accreditation program, the cost of an accreditation program is related to the complexity of the analytical method and to the number of methods for which a laboratory is seeking accreditation. The fee structure distributes the costs accordingly. The number of samples analyzed by the laboratory does not affect the time required by Department staff to perform onsite evaluations, review PT results and perform other activities that are required for determining the accreditation status of a laboratory.
Several commentators indicated that the Consumer Price Index escalator is a circumvention of the regulatory process. Linking fee increases to the changes in the Consumer Price Index does not allow for consideration of actual program costs to determine the fee charged to the regulated community. The escalator does not account for any future changes in the scope of the accreditation program. The establishment and change of fees is a fundamental regulatory step. The purpose of the regulatory review process is to avoid unchallenged or hurried decision-making. The change of fees should be subject to full public disclosure. This language regarding an automatic escalator should be removed from the proposed rulemaking.
Response: The Department removed the section that links increasing fees based upon increases to the Consumer Price Index.
Out-of-State Laboratories: Two commentators requested clarification about the time included in ''travel time.''
Response: Travel time only includes time spent traveling to and from the home office to the location of the out-of-State laboratory and does not include overnight time spent in a hotel before or after the assessment.
Several commentators indicated that the Department should consider reciprocating with other accreditation programs other than the National Environmental Laboratory Accreditation Program. These commentators suggested that the final-form rulemaking should include language giving the Department the ability to recognize reciprocal accreditation when granted by a program with guidelines similar to those of the Commonwealth.
Response: Section 4104(1) of the act limits the recognition of other accreditation programs to Federal or State accreditation programs. Additionally, the NELAC Standard requires that an accrediting authority be a state or Federal agency. The final-form rulemaking conforms to both the NELAC Standard and the act.
One commentator requested clarification on the criteria the Department planned to use to evaluate other accreditation programs to determine if they are substantially equivalent and meet the statutory requirements.
Response: The Department will consider the following items to determine if a State accreditation program is substantially equivalent to the requirements of § 252.205(a)(2)(ii): frequency and rigor of onsite evaluation; requirements for corrective action for deficiencies identified during the onsite evaluation; qualification requirements for laboratory supervisor and other laboratory personnel; PT requirements; authority to deny, revoke or suspend accreditation; recordkeeping requirements; quality manual requirements; and other quality control requirements. In accord with section 4104(1) of the act, recognition of other accreditation programs will be limited to Federal or State accreditation programs.
Laboratory Supervisor: Two commentators suggested changes to the requirements regarding designation of an alternate laboratory supervisor when the designated supervisor is absent for more than 15 days.
Response: An absence of a laboratory supervisor for more than 15 days could adversely affect the quality of the data produced by the laboratory, especially in the case of a laboratory that operates 7 days a week. The Department does not believe that designation of an alternate supervisor imposes an unreasonable burden on a laboratory. To accommodate the situation when the laboratory supervisor is absent for a 2-week vacation, including the initial and final weekends, the Department changed the final-form rulemaking to read more than 16 days, 6 weekend days plus 10 weekdays.
Several commentators indicated that the notification requirements concerning changes in supervisors, analysts, supervisor/analyst relationships, testing or analysis equipment or facilities were overly burdensome.
Response: The Department modified the notification requirements to limit the notification requirement to changes to information provided on the application for accreditation.
Several commentators objected to the inclusion of a reference to the laboratory supervisor subclassification for certified operators when a section delineating the requirements for the subclassification does not exist.
Response: Section 252.302(h)(2) and (3) is included because the regulation authorizing the subclassification is in the regulatory development process and the Department expects that proposed rulemaking will be submitted for consideration in the near future. There was no reason to postpone inclusion of this section. The section addresses the concerns of certified operators about being able to meet the formal educational requirements contained elsewhere in the final-form rulemaking. Certified operators who meet the laboratory supervisor grandfather provision can continue to act as the laboratory supervisor.
Personnel Requirements and Training: One commentator asked: How will an environmental laboratory know that it has sufficient personnel with the necessary education, training, technical knowledge and experience for their assigned functions? How will a laboratory know when it has satisfied this requirement? How will the requirement be enforced?
Response: A laboratory will have sufficient trained personnel when it is able to meet all quality control, documentation and reporting requirements of the final-form rulemaking and the promulgated method. The Department will review the practices and procedures of the laboratory for conformance with the requirements of the final-form rulemaking. Failure to analyze samples within required holding times, failure to maintain documentation, failure to perform required quality control and failure to follow method requirements would be evidence of lack of sufficient trained personnel.
One commentator indicated that the requirements for the documentation required under § 252.304(b)(4) and (8) were vague. Both items should be expanded to describe what documentation is required.
Response: Other areas of the rulemaking contain more specific provisions that address the intent of 252.304(b)(4) and (8). The Department removed these sections from the final-form rulemaking. Changes were made to § 252.706 (relating to recordkeeping) to clarify the records that an environmental laboratory must maintain.
Several commentators indicated the provisions for the ongoing demonstrations of capability for analysts go beyond the required quarterly QC samples and annual PTs. Requiring each member to be retested for proficiency in each method that a lab performs would be arduous. Repeated proficiency testing should only be required when there is a change in instrumentation or method.
Response: The Department strongly believes that demonstrating continued proficiency at least once every 12 months is a reasonable minimum. The analysts must only demonstrate continued proficiency for the tests the analysts performs. This demonstration does not require analysis of purchased PT samples. Options are provided that can easily be met by an individual that routinely performs a particular test or analysis. Specifically, the provision allowing for the use of four consecutive laboratory control samples would not add cost to the laboratory. Analyses of the laboratory control samples are necessary to meet other method and Chapter 252 requirements.
Equipment: Two commentators indicated the term visual comparison devices was vague and confusing.
Response: The Department agreed and replaced the term in the final-form rulemaking with spectro- photometer or colorimeter.
Two commentators indicated that the requirements for equipment calibration in § 252.306 were excessively specific. The commentators further indicated that the constant calibration and measurement of laboratory equipment is an unmanageable requirement that is equally difficult to enforce. The commentators requested that the Department draft a simpler requirement.
Response: Specific requirements for some commonly used equipment are included to eliminate the need for guidance documents and eliminate questions of interpretation. Small laboratories also requested that all requirements be included in a single document for ease of use. The requirements in the regulation are very similar to the requirements in the US EPA Manual for the Certification of Laboratories Analyzing Drinking Water, 5th Edition, January 2005, and in Standard Methods for the Examination of Water and Wastewater. The Department has been determining compliance with these requirements, or similar requirements from earlier versions of the same documents, as a routine part of the current Drinking Water Laboratory Certification Program since 1984. The Department believes the requirements are both understandable and enforceable.
One commentator asked who was considered a ''qualified person'' to service an analytical balance.
Response: A qualified person is a person that has been trained to service and calibrate an analytical balance. Service companies employ individuals who are specifically trained in servicing and calibrating analytical balances.
Methodology: Several commentators indicated the prescriptive nature of determining analytical methods exceeds some of the requirements of the Federal regulation. The EPA does not approve methods for testing that fall under a performance based measurement system (PBMS). Section 252.307(b) requires the laboratory to comply with applicable State or Federal regulations when selecting an appropriate method. The EPA's Office of Solid Waste has implemented a PBMS for all analytical measurements conducted in support of the Resource Conservation and Recovery Act of 1976 (42 U.S.C.A. §§ 6901--6986). The requirement of laboratories to comply with available Department methods denies a laboratory the flexibility to select a method that is most appropriate for that particular sample. It greatly limits the ability of laboratories to implement new and emerging technologies to meet mandated reporting requirements. The Department should amend any sections referring to methodology to allow laboratories flexibility in determining the most appropriate methodology available to them through a PBMS. In addition, the prescriptive nature of determining methods violates the requirements of Executive Order 1996-1, which prohibits the Commonwealth's regulations from exceeding Federal standards without a compelling reason.
Response: The final-form rulemaking does not violate the requirements of Executive Order 1996-1 because the laboratory accreditation program does not determine or specify which tests or methods are acceptable for use in a regulated program. Other programs within the Department or the EPA are responsible for the promulgation of methods and guidelines limiting the use of methods. No additional limitations on the acceptable use of methods are in this final-form rulemaking. The purpose of the laboratory accreditation program is to ensure that when a test or methodology is specified, the environmental laboratory analyzes the sample properly. Wording has been added to § 252.307(b)(2) to address situations that require use of a method considered appropriate for use.
One commentator asked how a laboratory would apply for permission to use an alternative procedure, the criteria for evaluation, the process for appeal and the mechanism for notification of the laboratory.
Response: A laboratory would apply for permission by submitting a request in writing to the Department. The Department is not requiring a specific format at this time to allow laboratories the flexibility to use various formats that are appropriate for the test method and analyte. The method for validation of an alternate or experimental procedure is dependant upon the analyte. The Department will utilize the EPA Guidelines, for example, Protocol for EPA Approval of Alternate Test Procedures for Organic and Inorganic Analytes in Wastewater and Drinking Water (EPA 821-B-98-002, March 1999), when available and when appropriate. A decision to allow or disallow an alternative or experimental procedure would be appealed to the Board. The Department will notify the laboratory by mail of its decision.
Records and Recordkeeping: Several commentators questioned the need to maintain records for 5 years when most NPDES permits only require that records be maintained for 3 years. Onsite captive laboratories should be allowed to follow the recordkeeping requirements of the permit for which the tests are made.
Response: The Department believes the maintenance of historical laboratory records is essential to data integrity. Requiring that an environmental laboratory maintain records for 5 years helps to insure that historical records will be available to reconstruct important and vital environmental data. Under some regulations, for example the drinking water program, the permitholder is only required to retain a summary of the results.
Three commentators indicated that there is no need for in-house captive laboratories to have a written procedure to transfer and assure maintenance of records if there is a change in ownership. Normally, the former permittee for whom the tests were conducted (the seller) must retain records covering their period of operation.
Response: The Department believes the maintenance of historical laboratory records is essential to data integrity. The procedure for the transfer of laboratory records may reference or be linked to the plan for transfer and maintenance of records of the parent facility in the event of a sale or closure. The plan could include transferring the records to the new owner or indicate that the seller would retain the responsibility for maintenance of the records.
Chemistry Quality Control Requirements: One commentator requested clarification for the term ''out-of-control'' as the term is used in § 252.401(i)(4) (relating to basic requirements).
Response: The Department does not believe that an additional clarification for the term ''out-of-control'' is required. This term is well understood by environmental laboratory personnel. An out-of-control situation is identified as any situation that does not conform to the requirements or expectations, or both, of the analytical method, regulation, or Chapter 252 requirements. Examples would include failed quality control, failed calibration curve and retention time shifts outside established retention time windows.
Toxicity Testing Quality Control Requirements: One commentator suggested that for clarity the laboratory accreditation regulations should cross reference the guidance documents regarding the counting of neonates, algae cells and weighing of fish for selected endpoints. Also, the commentator indicated that the size requirements for an incubator should be clearer regarding the meaning of ''refrigerator-sized.''
Response: The Department agrees with the commentator and appropriate changes were made to the final-form rulemaking.
Radiochemistry Quality Control Requirements: One commentator questioned if there may be situations where the method and regulations would differ with regard to acceptance criteria for instrument suitability standards. See § 252.405(d)(8) (relating to essential quality control requirement--radiochemistry).
Response: Yes, there may be situations when the final-form rulemaking imposes different, and more stringent requirements, than the method. For example, the EPA drinking water program often establishes very specific quality control requirements in regulation that exceed the requirements of the promulgated method. In that instance, the Federal program regulation requirements would take precedence.
Coordination with Other Regulations: One commentator pointed out that the preamble to the proposed rulemaking indicated that the requirements in Chapter 109, Subchapter 109 would be deleted and moved to this final-form rulemaking. The proposed rulemaking did not include deletion of Chapter 109 requirements.
Response: It has clearly been the intent of the Department that this final-form rulemaking would replace and supersede Chapter 109, Subchapter H that describes the requirements of the laboratory certification. Appropriate amendments to Chapter 109 are included in this final-form rulemaking. The Department is also proposing similar amendments to Chapter 78 to avoid any potential conflict or confusion.
G. Benefits, Costs and Compliance
Benefits
The most significant benefit of the final-form rulemaking is an improvement in the overall quality of the data produced by environmental laboratories. Improved data quality will allow the Department, the regulated community and the citizens of this Commonwealth to make better decisions concerning the protection of the environment and protecting public health, safety and welfare. Accurate laboratory results are critical to achieving the goals of the environmental laws.
It is difficult to quantify the benefits of Chapter 252 in specific dollar amounts. One approach to partially quantify the benefit is to examine the extra costs associated with unacceptable data. Fines assessed against environmental laboratories guilty of producing fraudulent data or of producing data that does not meet the regulatory requirements range from several thousand dollars to over $9 million. These fines reflect the amount of harm done to the environment or to public health by poorly operated laboratories. When an environmental laboratory fails to provide accurate and valid data, additional testing and analysis and costly remediation is often required. This environmental laboratory accreditation program is a proactive approach designed to prevent problems before they become critical and responds to the mandate given by the General Assembly to the Department.
Compliance Costs
An environmental laboratory that is accredited-by-rule will incur no additional compliance costs. For other environmental laboratories, the direct costs for compliance will be payment of the required fees and the purchase of PT samples. These costs will vary depending upon the type of testing and analyses that the environmental laboratory chooses to perform. The annual application fees will range from $850 to $13,600. The cost for the PT samples range from less than $100 to approximately $13,000. The Department believes that the accreditation requirements will not result in prohibitive cost increases for any environmental laboratory. The Department is required to set fees in an amount sufficient to cover the cost of establishing and maintaining a laboratory accreditation program.
The final-form rulemaking contains a fee structure that is responsive to the needs of small laboratories. Categories of testing are included for basic drinking water parameters and for basic wastewater parameters as a group. Additional tests were added to the basic wastewater parameter group in response to comments received. These groupings include the tests usually performed by the smaller drinking water and wastewater facilities. Additionally, it has been the Department's experience in the drinking water laboratory accreditation program that accreditation is affordable for many small laboratories. Many small and municipal laboratories have met similar requirements under the Drinking Water Program regulations in Chapter 109.
Laboratories performing testing in the wastewater program are already required to use approved methods, many of which have requirements similar to this final-form rulemaking. Also, many of the laboratories performing testing in the wastewater program currently participate in PT studies.
Compliance Assistance Plan
The ultimate goal of the compliance assistance effort will be improving an environmental laboratory's ability to produce valid and defensible data for use by the Department, the regulated community and the public. Several areas where compliance assistance is necessary are general laboratory operation, correct performance of specific test procedures and documentation of laboratory activities. These areas, as well as others yet to be identified, will be provided to all environmental laboratories regardless of size or location within this Commonwealth. Several different ways of providing assistance have been identified.
The Department will develop a compliance guide to help an environmental laboratory understand the compliance requirements associated with any final-form or newly adopted regulations. Initially, the compliance guide would be tailored to the smallest wastewater and drinking water environmental laboratories because these laboratories are expected to be the least familiar with the requirements of a laboratory accreditation program. The guide would address the requirements for the basic testing performed by these smaller laboratories. Eventually the compliance guide may be expanded to larger laboratories. Additionally, the Department will develop and provide formal training courses or seminars that would assist environmental laboratories as they prepare for accreditation.
The training courses or seminars would present information that would be applicable to all environmental laboratories, regardless of size and would be presented across this Commonwealth at numerous locations. Possible sites include the Department's laboratory and regional and district offices, colleges or universities, hotels and other training facilities. The seminars and courses may be presented in conjunction with existing organizations, such as the Pennsylvania Rural Water Association, the Pennsylvania Association of Accredited Environmental Laboratories and the Pennsylvania Municipal Authorities Association.
Finally, a periodic newsletter may also be developed to provide updates about the environmental laboratory accreditation program in this Commonwealth. The Department may also expand the use of technology-based solutions to provide additional mechanisms for asking for and receiving assistance. Possible mechanisms for providing and making compliance assistance materials available include the use of the Department's website, e-mail and a toll-free telephone number.
Paperwork Requirements
An application for accreditation shall be submitted each year. On the application for accreditation, the environmental laboratory will be asked to supply the Department with information about the laboratory supervisor, the areas for which accreditation is being requested and basic information about the environmental laboratory, such as the address, telephone number and hours of operation.
An environmental laboratory will be required to follow specific recordkeeping procedures. An environmental laboratory is required to maintain documentation that describes the testing and analysis performed and to permit a scientist to reconstruct all activities associated with producing the reported result. The environmental laboratory shall maintain the records for a minimum of 5 years and the laboratory shall have a written plan that specifies how records will be maintained or transferred in the event that the laboratory transfers ownership or terminates operations.
Basic documentation includes a document describing the policies and procedures that an environmental laboratory instituted to insure the production of good quality data. This document is generally referred to as a quality manual. An environmental laboratory is also required to maintain SOPs describing how the laboratory performs the test or analysis. The quality manual and SOPs may be separately prepared documents, a copy of a standard policy or procedure or a cut and paste copy of a method or manual. The only specific requirement is that it accurately reflects and fully describes the operation of the environmental laboratory. Thus, small laboratories that perform a limited number of tests will only need to develop a quality manual and SOPs suited to their particular circumstances. In addition to assuring quality data and consistency among analysts, these documents may provide significant benefits to small laboratories in the event of staff turnover because the ''institutional memory'' of the laboratory will be preserved.
H. Pollution Prevention
This final-form rulemaking will neither promote nor discourage a multimedia pollution prevention approach. Essentially all of the procedures or methods used for testing or analysis have a pollution prevention component incorporated into them. This final-form rulemaking will assure that the laboratories are following the promulgated methods. This final-form rulemaking does contain a mechanism for the approval of alternate methods that use new or innovative technologies on a case-by-case basis. Innovative technologies often use less chemicals and therefore effectively work to reduce the amount of hazardous waste generated resulting in pollution prevention.
I. Sunset Review
The final-form rulemaking will be reviewed in accordance with the sunset review schedule published by the Department to determine whether the regulations effectively fulfill the goals for which they were intended.
J. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on December 20, 2004, the Department submitted a copy of the notice of proposed rulemaking, published at 35 Pa.B. 519 (January 22, 2005), to IRRC and the Chairpersons of the House and Senate Environmental Resources and Energy Committees for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC and the Committees were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Department has considered all comments from IRRC, the House and Senate Committees and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on November 30, 2005, the final-form rulemaking was deemed approved by the House and Senate Committees. Under section 5.1(e) of the Regulatory Review Act, IRRC met on December 1, 2005, and approved the final-form rulemaking.
K. Findings
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No 241) (45 P. S. §§ 1201 and 1202) and regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) This final-form rulemaking does not enlarge the purpose of the proposal published at 35 Pa.B. 519.
(4) This final-form rulemaking is necessary and appropriate for administration and enforcement of the authorizing acts.
L. Order
The Board, acting under the authorizing statutes, orders that:
(a) The regulations of the Department, 25 Pa. Code Chapters 78, 109 and 252, are amended by amending §§ 78.1, 78.52, 109.801 and 109.810; by deleting §§ 78.141--78.146 and 109.802--109.809; and by adding §§ 252.1--252.6, 252.201--252.207, 252.301--252.307, 252.401--252.405, 252.501, 252.601 and 252.701--252.708 to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.
(b) The Chairperson of the Board shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for review and approval as to legality and form, as required by law.
(c) The Chairperson of the Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau, as required by law.
(d) This order shall take effect immediately upon publication in the Pennsylvania Bulletin.
KATHLEEN A. MCGINTY,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission, relating to this document, see 35 Pa.B. 6852 (December 17, 2005.)
Fiscal Note: Fiscal Note 7-392 remains valid for the final adoption of the subject regulations.
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