PROPOSED RULEMAKING
ENVIRONMENTAL
QUALITY BOARD
[25 PA. CODE CH. 252]
Environmental Laboratory Accreditation
[35 Pa.B. 519] The Environmental Quality Board (Board) proposes to add Chapter 252 (relating to environmental laboratory accreditation). The proposed rulemaking delineates the requirements for accreditation of environmental laboratories.
This order was adopted by the Board at its meeting of August 17, 2004.
A. Effective Date
The proposed rulemaking will go into effect upon final-form publication in the Pennsylvania Bulletin.
B. Contact Persons
For further information contact Richard H. Sheibley, Chief, Laboratory Accreditation Program, P. O. Box 1467, Evangelical Press Building, Harrisburg, PA 17105-1467, (717) 705-2425; 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 by calling (800) 654-5984 (TDD users) or (800) 654-5988 (voice users). This proposed rulemaking is available on the Department of Environmental Protection's (Department) website: www.dep.state.pa.us.
C. Statutory Authority
This proposed 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 and Purpose
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 the proposed 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 proposed rulemaking includes only items that are essential for the production of good quality data.
The proposed 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 Conversion Act (52 P. S. §§ 1406.1--1406.21).
12. The Noncoal Surface Mining Conservation and Reclamation Act (52 P. S. §§ 3001--3326).
This proposed rulemaking would transfer the laboratory accreditation program, currently under the Safe Drinking Water Program (25 Pa. Code Chapter 109 (relating to safe drinking water)), 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. The Federal 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 outlined in the proposed rulemaking for the 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 proposed rulemaking. To meet the requirements contained 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 cost for an environmental laboratory to become accredited to the NELAC Standard is significantly higher than the anticipated cost for the proposed rulemaking.
The proposed 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 proposed rulemaking, or seek accreditation using the NELAC Standard as a voluntary alternative to this proposed 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 State accreditation standards described by this proposed rulemaking for fields of accreditation not included under the NELAC Standard.
The Laboratory Accreditation Advisory Committee (LAAC) provided technical assistance throughout the development of the draft rulemaking. The LAAC met approximately every other month from August 2002 through April 2004 and advised the Department on the development of 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) associated with this proposed rulemaking. Essentially all of the recommendations from the joint meeting have been incorporated into this proposed rulemaking.
The LAAC reviewed the draft proposed rulemaking on April 13, 2004, and unanimously supported moving the draft rulemaking forward to the Board. The CPAC and the State Board for Certification of Water and Wastewater Systems Operators (Certification Board) reviewed the draft proposed rulemaking on April 29, 2004, and supported moving the draft rulemaking forward to the Board. However, the CPAC and the Certification Board opposed the use of the Consumer Price Index (CPI) as a means to automatically adjust accreditation fees to cover changes in the costs of administering the program due to inflation. Instead, the CPAC and the Certification Board recommended that fee increases occur through the regulation process. The proposed rulemaking retains the CPI fee adjustment language.
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 proposed rulemaking where 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 LAAC recommended to the Department that to be accredited-by-rule, a test parameter must meet at least one of the following criteria:
1. A test with a holding time of 2 hours or less.
2. A noninstrumental observational test.
3. A screening test to determine if further laboratory testing is required, except for those required for compliance determinations.
4. The sample cannot be transferred/transported without degradation.
5. Process testing used for immediate decision making purposes.
6. A test allowed by another program regulation.
Additionally, the Department identified two additional criteria for evaluating the tests or analyses to include under accreditation-by-rule. The additional criteria are:
1. The test or analysis is relatively easy to perform.
2. An improperly performed test has minimal impact on the environment or the public health, safety and welfare.
The proposed 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 proposed 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, the following are not included under accreditation-by-rule, total residue testing, biochemical oxygen demand testing and fecal coliform testing.
Consistent with the requirements of the act, the proposed 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 proposed 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 proposed rulemaking. The proposed 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 proposed rulemaking identifies the responsibilities of a laboratory supervisor. The proposed rulemaking provides that a person may be a supervisor of more than one laboratory under certain conditions.
E. Summary of Regulatory Requirements
Subchapter A
§ 252.1--The definitions section explains the intended meaning for all terms used in the proposed rulemaking.
§ 252.2--This section explains that the purpose of the proposed rulemaking 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. The proposed rulemaking provides the minimum requirements for an environmental laboratory to obtain and maintain accreditation in this Commonwealth.
§§ 252.3 and 252.4--Environmental laboratories performing analysis of solids, liquids or other specimens for the purpose of testing or analysis as required by an environmental statute listed in this section must meet the requirements of the proposed rulemaking. The scope of the proposed rulemaking is limited to drinking water, nonpotable water (wastewater) and solid and chemical materials.
§ 252.5--An environmental laboratory may choose Pennsylvania State accreditation, described by the proposed rulemaking, or seek accreditation using the NELAC Standard as a voluntary alternative to this proposed 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 State accreditation standards described by the proposed rulemaking for fields of accreditation not included under the NELAC Standard.
§ 252.6--Accreditation-by-rule is offered to a facility performing testing or analysis of samples for the tests specifically listed in this section. The accreditation-by-rule provision requires analysis of all parameters by the promulgated analytical method, when specified; proper sample handling and preservation; compliance with all other applicable environmental laws; and documentation of all tests and results. The Department may require an environmental laboratory that is accredited-by-rule to apply for, and obtain, environmental laboratory accreditation when the laboratory is not in compliance with the conditions of the accreditation-by-rule provision.
The Safe Drinking Water regulatory requirements for accreditation-by-rule are listed by reference. An environmental laboratory must meet the requirements of Chapter 109 as well as those listed in the proposed rulemaking to be accredited-by-rule for drinking water parameters.
In addition to the tests specifically listed in this section, industrial wastewater treatment facility laboratories and wastewater treatment facility laboratories are accredited-by-rule to perform tests that are not mandated by the Department.
An environmental laboratory deemed to be accredited-by-rule under these regulations is not required to meet any other requirements of the regulation, including laboratory supervisor requirements, fees, onsite assessments and quality manuals.
Subchapter B
§§ 252.201--252.203--Each environmental laboratory accredited under this proposed rulemaking is required to complete an initial application for accreditation, an annual renewal application and notify the Department of change or transfer of ownership. Failure to submit an application for renewal of accreditation within 60 days of the expiration date of the current certificate of accreditation may result in a lapse in accreditation.
§ 252.204--An environmental laboratory will pay an initial application fee and annual renewal fees to the Department. Under the act, the fees provided in this section must be sufficient to pay the Department's cost of implementing and administering the accreditation program including processing applications for certificates of accreditation, the issuance, renewal, modification or other action relating to the certificate. The laboratories pay fees based on the number and complexity of the methods for which they request accreditation. The cost of each fee category is determined based on the number of assessor hours necessary to accredit an environmental laboratory for a method in that given category.
The fee structure 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. Included in these groupings are the tests usually performed by the smaller drinking water and wastewater facilities.
The fees will change every 3 years based on the percentage change in the CPI. The CPI would be used to offset the effects of inflation. The first change will be based on the increase in the CPI from June 30, 2005, to June 30, 2008. The Department will use that figure to calculate the fees for the year beginning January 1, 2009. The Department will publish the revised fee table in the Pennsylvania Bulletin at least 90 days prior to the effective date of the revision. This allows time for budget planning and was added in direct response to comments offered by the LAAC. The Department will develop a guidance document that will list equivalent methods for which one method fee will be charged when several methods are technically similar but are assigned different method identifiers.
§ 252.205--This section outlines the mechanism by which an out-of-State environmental laboratory may apply for and obtain accreditation from the Department. An out-of-State environmental laboratory performing testing or analysis covered by this proposed rulemaking will be required to maintain accreditation according to this proposed rulemaking. Out-of-State laboratories will pay the same fees as in-State laboratories. The Department will recognize accreditation granted by a NELAP accrediting authority in another state for the same fields of accreditation for which the Department is a primary NELAP accrediting authority. The laboratory requesting secondary NELAP accreditation through the Pennsylvania program must submit an application, appropriate fee, copies of a valid accreditation certificate and onsite assessment from the primary accrediting authority and all PT sample results.
§ 252.206--An out-of-State environmental laboratory requiring an onsite evaluation shall reimburse the Department for all expenses associated with the onsite evaluation including travel, subsistence and lodging. The reimbursement rate for the travel time for each assessor is based upon salary and benefit costs for an assessor and would be $50 per hour.
Subchapter C
§ 252.301--The proposed rulemaking specifies the responsibilities of the laboratory supervisor, including the direct supervision of the testing analysis and reporting of data and certifying that each test or analysis is accurate and valid. The laboratory supervisor is responsible for the data generated in the laboratory. Specific qualifications are not established for other technical personnel in the laboratory.
§ 252.302--The proposed rulemaking establishes qualification requirements for laboratory supervisors. The laboratory supervisor qualifications vary depending on the type of laboratory and the scope of its requested accreditation. All laboratory supervisors shall have experience in the areas for which they are responsible. Drinking water or wastewater operators with a valid treatment plant operator's certificate as a laboratory supervisor would qualify as a laboratory supervisor for an appropriately classified laboratory in accordance with their plant operator's certificate.
If the laboratory supervisor subclassification is not available by the time this proposed rulemaking becomes effective, the proposed 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.
§ 252.303--The grandfathering provisions for laboratory supervisors allows laboratory supervisors acting in that capacity at least 12 months before adoption of the proposed rulemaking to continue in that position at that facility without meeting the educational requirements listed in the laboratory supervisor section. Approval under this provision will be limited to the current facility and may not be transferred to a different environmental laboratory.
§ 252.304--The personnel requirements for the technical staff of an environmental laboratory, including responsibility for compliance with quality assurance and quality control requirements of the rulemaking, methods and laboratory are set forth in this section. The laboratory management shall define the minimum level of qualification, experience and skills necessary for all positions; document the required training and demonstrations of capability required before analysis of environmental samples; and ethics training.
§ 252.305--The laboratory must assure that the facility does not introduce contamination to the samples or compromise sample results.
§ 252.306--The laboratory must have the necessary equipment to perform the testing or analysis for which accreditation is sought. The environmental laboratory shall maintain records of each item of equipment including maintenance, calibration and history of damage, malfunction or repair. Specific requirements are outlined for the calibration and maintenance of laboratory support equipment.
§ 252.307--The laboratory shall select analytical methods that are appropriate for the analyte and sample matrix, comply with applicable State or Federal regulation and that produce the appropriate quantitative levels. The laboratory must develop and maintain standard operating procedures (SOP) for all fields of accreditation. The SOPs must adequately address method requirements and reflect the laboratory specific procedures. The laboratory SOP may be a separately prepared document, a copy of a standard procedure or a cut and paste copy of a method. The proposed rulemaking specifies 11 basic items required in the laboratory SOP. All SOPs must be available to the analysts employed by the environmental laboratory. Each analyst must adequately demonstrate capability for each field of accreditation before sample analysis through acceptable completion of an initial demonstration of capability study.
Subchapter D
§ 252.401--An environmental laboratory shall develop and maintain a quality manual appropriate to the type, range and volume of testing and analysis of environmental samples. The quality manual includes procedures for document control, sample handling and acceptance policies, ethics policy statements and management's processes and procedures for permitting departures from the established procedures. Each section outlines the essential quality control requirements for chemistry, toxicity, microbiology and radiochemistry.
§ 252.402--The essential quality control requirements for chemistry section include information detailing initial calibration, calibration verifications, method blanks, laboratory control samples, duplicates, surrogate spikes, detection limits and selectivity.
§ 252.403--The essential quality control requirements for toxicity testing section specifies requirements for positive and negative controls, sensitivity, reagent water, test organisms, sample holding times and testing conditions.
§ 252.404--The essential quality control requirements for microbiology section includes requirements for autoclaves, ovens, miscellaneous equipment, reagent water, media, positive and negative controls and test variability.
§ 252.405--The essential quality control requirements for radiochemistry section specifies requirements for initial calibration, instrument stability verification and background measurement, method blanks, laboratory control samples, duplicates, tracers, carriers and detection limits.
Subchapter E
§ 252.501--Each laboratory must participate in PT studies, when available, for each field of accreditation that the laboratory seeks to obtain or maintain accreditation. For continued accreditation for a particular field of accreditation, a laboratory must successfully analyze one PT study for each field of accreditation every 12 months. The closing date of each PT study for a particular field of accreditation may not be more than 13 months apart. The PT studies shall be managed, analyzed and reported in the same manner as real environmental samples. The environmental laboratory shall utilize the same staff, instrumentation, quality control and frequency of analyses when analyzing PT study samples.
Subchapter F
§ 252.601--Each laboratory applying for accreditation under the proposed rulemaking would undergo onsite assessments. The Department may conduct announced or unannounced onsite assessments of an environmental laboratory to ensure compliance with the conditions of accreditation, Chapter 252 or orders issued by the Department. During the onsite assessment, the laboratory's processes and procedures would be reviewed. Analyst interviews, training, method reviews, data audits and documentation procedures are all areas of evaluation during the onsite assessment. The Department would supply a written report outlining the environmental laboratory's deficiencies. The laboratory must respond to the deficiency report within 60 days and correct all deviations within 120 days of receipt of the onsite report.
Subchapter G
§§ 252.701--252.705--These sections explain application procedures including expiration, denial, suspension, revocation and voluntary relinquishment of accreditation. Each section details the procedures the laboratory must understand and the grounds for which the Department may implement the listed procedures.
§ 252.707--Laboratories must follow specific recordkeeping procedures. These procedures include maintaining records in a manner that allows reconstruction of all laboratory activities. The environmental laboratory must maintain the records required by the proposed rulemaking for a minimum of 5 years. 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.
§ 252.708--The environmental laboratory shall indicate the subcontracted laboratory on the final report. The environmental laboratory may not subcontract testing or analysis covered under the proposed rulemaking to an environmental laboratory that is not accredited and in compliance with this proposed rulemaking.
§ 252.709--The proposed rulemaking incorporates the reporting and notification requirements for the Safe Drinking Water regulations in Chapter 109 by reference. This section also outlines the requirements for laboratories to notify the Department of any personnel changes including laboratory supervisors and analysts, equipment or facility changes that affect the accredited fields of accreditation, legal name changes of the applicant laboratory, structural changes or relocations. Out-of-State environmental laboratories with either primary or secondary accreditation shall notify the Department of any changes of accreditation from any other primary accrediting authority within 48 hours of the change.
F. Benefits, Costs and Compliance
Benefits
The most significant benefit of the proposed rulemaking will be 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 $1,000 to $17,400. 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 proposed 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. 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 proposed 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 proposed 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 must 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.
G. Sunset Review
The proposed 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.
H. 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 this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House and Senate Environmental Resources and Energy Committees. A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, IRRC may convey any comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections must specify the regulatory review criteria which have not been met. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the rulemaking, by the Department, the General Assembly and the Governor of comments, recommendations or objections raised.
I. Public Comments
Written Comments--Interested persons are invited to submit comments, suggestions or objections regarding the proposed rulemaking to the Environmental Quality Board, P. O. Box 8477, Harrisburg, PA 17105-8477 (express mail: Rachel Carson State Office Building, 15th Floor, 400 Market Street, Harrisburg, PA 17105-2301). Comments submitted by facsimile will not be accepted. The Board must receive comments, suggestions or objections by February 22, 2005. Interested persons may also submit a summary of their comments to the Board. The summary may not exceed one page in length and must also be received by February 22, 2005. The one-page summary will be provided to each member of the Board in the agenda packet distributed prior to the meeting at which the final regulations will be considered.
Electronic Comments--Comments may be submitted electronically to the Board at RegComments@state.pa.us and must also be received by the Board by February 22, 2005. A subject heading of the proposal and a return name and address must be included in each transmission. If an acknowledgement of electronic comments is not received by the sender within 2 working days, the comments should be retransmitted to ensure receipt.
KATHLEEN A. MCGINTY,
ChairpersonFiscal Note: 7-392. No fiscal impact; (8) recommends adoption.
(Editor's Note: The following sections are new and are printed in regular type to enhance readability.)
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