RULES AND REGULATIONS
Title 25—ENVIRONMENTAL PROTECTION
ENVIRONMENTAL QUALITY BOARD
[25 PA. CODE CH. 252]
Environmental Laboratory Accreditation
[47 Pa.B. 4085]
[Saturday, July 29, 2017]The Environmental Quality Board (Board) amends Chapter 252 (relating to environmental laboratory accreditation) to read as set forth in Annex A. This final-form rulemaking clarifies existing requirements, deletes or amends overly restrictive and cost prohibitive requirements, and includes additional requirements necessary for laboratory accreditation. This final-form rulemaking also amends the fee structure in § 252.204 (relating to fees).
This final-form rulemaking was adopted by the Board at its meeting of April 18, 2017.
A. Effective Date
This final-form rulemaking will be effective upon publication in the Pennsylvania Bulletin.
B. Contact Persons
For further information contact Aaren S. Alger, Chief, Laboratory Accreditation Program, P.O. Box 1467, Harrisburg, PA 17105-1467, (717) 346-8212; or William S. Cumings, Jr., 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 Pennsylvania AT&T Relay Service at (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) web site at www.dep.pa.gov (select ''Public Participation,'' then ''Environmental Quality Board (EQB)'').
C. Statutory Authority
This final-form rulemaking is being made under the authority of 27 Pa.C.S. § 4105(a) (relating to powers and duties of Environmental Quality Board), which directs the Board to adopt regulations as necessary to implement 27 Pa.C.S. Chapter 41 (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
The regulations governing environmental laboratory accreditation in Chapter 252 became effective on January 28, 2006, and were amended on April 10, 2010. While completing ongoing rounds of laboratory assessments under Chapter 252, the Laboratory Accreditation Program (Program) discovered various provisions that were unclear, where the regulations were lacking sufficient detail to ensure full compliance with the regulatory requirements or where the standards were overly restrictive and cost prohibitive. The Program also determined that several necessary standards for accreditation were lacking. This final-form rulemaking amends various citations within the scope of Chapter 252, but the applicable statutes within the scope of the regulations remain unchanged.
Under 27 Pa.C.S. § 4104(6) (relating to powers and duties), the accreditation fees must be ''in an amount sufficient to pay the department's cost of implementing and administering the accreditation program.'' In addition, § 252.204(b) requires the Department to recommend to the Board regulatory changes to the accreditation fees every 3 years to address any disparity between Program income generated by the fees and Program costs. In accordance with this requirement, the Program compared the work necessary to perform the functions of the Program to evaluate the costs associated with the Program. Based on this analysis, the Department determined that the accreditation fees in § 252.204 were not sufficient to recover the Department's costs to implement the Program. This final-form rulemaking provides a new fee structure to cover the costs of the Program.
The Department worked with the Laboratory Accreditation Advisory Committee (LAAC) to amend Chapter 252 in a manner that ensures appropriate requirements for environmental laboratory accreditation. The Department, with the assistance of the LAAC, ensured that the interests, concerns and needs of the regulated community were considered and implemented appropriately. The LAAC met throughout 2014, 2015 and 2016 to review and comment on drafts of the proposed and final-form Chapter 252 amendments presented by the Department. The Department also discussed the written comments received during the public comment period during a meeting of the LAAC on December 7, 2016. On December 7, 2016, the LAAC unanimously voted to recommend the final-form Chapter 252 amendments for presentation to the Board.
E. Summary of Changes to the Proposed Rulemaking
Editorial corrections and revisions were made throughout this final-form rulemaking based on comments received during the public comment period and to ensure that this final-form rulemaking meets the requirements of the Pennsylvania Code & Bulletin Style Manual. For example, the term ''but not limited to'' was deleted throughout.
Subchapter A. General provisions
§ 252.3. Scope
The list of applicable statutes for which environmental testing shall be conducted by an accredited laboratory is amended to accurately reflect correct statute names and citations.
Subchapter B. Application, fees and supporting documents
§ 252.201. Application and supporting documents
§ 252.203. Accreditation renewal
In this final-form rulemaking, ''on forms provided by the Department'' is added in response to a comment by the Independent Regulatory Review Commission (IRRC) concerning the format and content of the application requirements that environmental laboratories shall submit. This final-form rulemaking adds additional language to § 252.203(d) (relating to accreditation renewal) at the suggestion of IRRC to add clarity to the written client notification requirements for laboratories when the laboratory's accreditation certificate expires. Laboratories are required to notify all affected customers of the loss or lapse in accreditation in writing within 48 hours of the certificate expiration. This additional language explains that the Department may choose to require the use of specific language or to require Department approval of the notice before issuance.
Subchapter C. General standards for accreditation
§ 252.304. Personnel requirements
The requirement for laboratory personnel to meet any more stringent qualification requirements established by method, regulation or program is added as subsection (a)(4) in response to comments received during the public comment period. The proposed rulemaking included this provision in the laboratory supervisor qualifications section, but, as noted by two commentators, this provision is also applicable to some laboratory personnel.
§ 252.306. Equipment, supplies and reference materials
The allowance for recertification of expired standards, reagents and media in subsection (h)(6) is deleted in this final-form rulemaking based on a comment received from the public. The Department added this provision in 2010. No laboratory has sought approval from the Department for approval to recertify expired laboratory materials. Therefore, removal of this provision does not negatively impact the regulated community and will ensure that laboratories use valid standards.
At the suggestion of several public comments, the provision for temperature distribution studies for microbiology incubators in subsection (j) is revised to exempt this requirement for circulating water baths. Circulating water baths ensure even temperature distribution throughout the incubator. Distribution studies are not necessary to ensure valid temperature distribution throughout the unit.
§ 252.307. Methodology
At the suggestion of a commentator, the Department deletes the requirement for a laboratory to develop the sample collection and preservation documents from subsection (j). The Department does not intend to require a laboratory to develop procedures that might already exist or be available from other organizations provided that the sample collection and preservation instructions meet the requirements of subsections (f) and (g).
Subchapter D. Quality assurance and quality control requirements
§ 252.401. Basic requirements
Significant public comment and discussion during public meetings of the LAAC resulted in the addition to subsection (f) requiring that environmental laboratories check and document the pH of every sample container received by a laboratory. Numerous comments and concerns were raised regarding the proposed language, the necessity of the requirements and the overall cost to the regulated community. After much discussion and consideration, this final-form rulemaking requires that the laboratory check the pH of each sample container for safe drinking water act compliance samples and whole effluent toxicity samples that are not collected by trained, accredited laboratory staff. The Safe Drinking Water (SDW) Program and the United States Environmental Protection Agency's (EPA) Office of Water consider an improperly preserved sample invalid for compliance purposes. Therefore, unless each sample container used for sample analysis is verified to be at the correct pH, it is not possible to determine if the sample is valid and appropriately collected. This compromise ensures protection of the public health for drinking water compliance samples but does not place an undue burden, financial or otherwise, on the regulated community testing nondrinking water samples.
§ 252.404. Essential quality control requirement—micro- biology
This final-form rulemaking adds necessary clarification to subsection (g)(2) to more thoroughly explain that a reuseable membrane filtration funnel shall be checked for sterility with a sterility blank after every ten filtrations of a sample aliquot, not after every ten samples. A sample could include numerous dilutions and aliquots. Based on comments received, the Department deletes the proposed addition to subsection (h)(4) and (5) to allow for the recertification of expired positive and negative culture controls. As suggested by a commentator, the Department adds subsection (h)(7) in this final-form rulemaking to ensure that positive and negative controls are processed under the same conditions as routine environmental samples. ''Department approved'' was proposed to be added to subsection (h)(5) with the intention to require the laboratories to obtain approval for their documented procedures for maintaining culture controls. This statement was determined to be unnecessary because the regulation outlines the specific requirements for maintaining culture controls. Therefore, the additional language proposed by the Department is not adopted in this final-form rulemaking.
Subchapter F. Assessment requirements
§ 252.601. Assessment requirements
Subsection (h) is revised in this final-form rulemaking in response to a comment from IRRC regarding the Department's requirements for corrective action based on deficiencies found during an assessment conducted by the Program. This final-form rulemaking clarifies that unless otherwise required or approved by the Department, environmental laboratories shall correct all deficiencies within 120 calendar days of receipt of the assessment report. Assessments occur for various reasons, including onsite assessments, review of a laboratory's request to add fields of accreditation, change in ownership and laboratory supervisor notices, and the like. Laboratories are required to perform corrective actions and submit any requested evidence of correction to the Program to demonstrate compliance with the regulation. Subsection (h) clarifies that the Program can require the laboratory to correct the violation sooner than 120 days; a laboratory can be granted additional time for correction based on subsection (i).
Subchapter G. Miscellaneous provisions
§ 252.702. Revocation
§ 252.703. Suspension
§ 252.704. Voluntary relinquishment
This final-form rulemaking adds additional language to §§ 252.702(d), 252.703(e) and 252.704(c) (relating to revocation; suspension; and voluntary relinquishment) at the suggestion of IRRC to add clarity to the written client notification requirements for laboratories when a voluntary relinquishment, loss or lapse in accreditation occurs. Laboratories are required to notify all affected customers of the loss or lapse in accreditation in writing within 72 hours of the change in accreditation status. This additional language explains that the Department may choose to require the use of specific language or to require Department approval of the notice before issuance.
§ 252.706. Recordkeeping
Based on public comment, this final-form rulemaking deletes the signature requirement from subsection (c) to state that the name or initials must be included on the records. Subsection (b)(5) is corrected to note that the results of chemical ''or'' thermal preservation verifications or adjustments, or both shall be documented. This final-form rulemaking more clearly explains the Department's requirements for historical reconstruction of laboratory activities in subsection (c)(2) when making changes to records. Specifically, the laboratory is expected to document the rationale for any nontypographical correction to records.
F. Summary of Comments and Responses on the Proposed Rulemaking
The Board approved publication of the proposed rulemaking at its May 17, 2016, meeting. The proposed rulemaking was published at 46 Pa.B. 5088 (August 20, 2016), with a 30-day public comment period. Comments were received from ten commentators, including IRRC.
The majority of the comments received during the public comment period related to requirements for microbiology incubation units, laboratory supervisor qualifications, sample acceptance and sample receipt, expired materials and a general request for technical guidance documents from the Department to describe and detail compliance options with the new requirements.
Several commentators noted that the Department's proposal to require temperature distribution studies for incubation units used for microbiology testing should be revised. These commentators noted that circulating water baths are equitably distributed by design and should be exempt from the distribution study. The Department agreed with these comments and added language to this final-form rulemaking to exempt circulating water baths from the temperature distribution study.
Commentators stated that it would be helpful to have the Department develop technical guidance for how the Department would recommend compliance with the requirements for microbiology incubators detailed in the proposed rulemaking. The Department plans to develop technical guidance documentation in collaboration with the LAAC. These technical guidance documents will provide more detailed examples and options for how a laboratory might achieve compliance with the regulatory requirements for microbiology incubators regarding temperature distribution studies and the daily temperature monitoring requirements.
Several commentators provided comment regarding the Department's proposal to amend the laboratory supervisor qualification requirements. Some of the commentators expressed concern that the proposed reduction in years of experience for inorganic nonmetals, basic water and wastewater, and basic microbiology might weaken the quality of results generated by accredited laboratories. Other commentators expressed support of the Department's proposal and suggested that it will be easier to find qualified laboratory supervisors with the reduction in years of experience. One commentator suggested that the Department should not reduce the years of experience, but should increase the years of experience and minimum number of college semester credit hours for all areas of supervision. The Department carefully considered these comments and determined that the language should remain the same in this final-form rulemaking regarding the qualifications for a laboratory supervisor. The methodologies and analytical technologies within the inorganic nonmetals, basic microbiology, and basic drinking water and wastewater areas of testing are less complicated and more easily mastered. One year of experience in these areas should be sufficient to obtain mastery in these technical disciplines and will also enable smaller laboratories to more easily comply with the accreditation regulations, thus reducing the burden on small businesses and publicly-owned laboratories. The Department's requirements for laboratory supervisor experience and education for the other areas of laboratory testing, organics, trace metals and complex microbiology are similar to those established by the National Environmental Laboratory Accreditation Program (NELAP) and the requirements of this final-form rulemaking are adequate to ensure proper experience and education of a laboratory supervisor.
Several commentators expressed concern that the Department's proposal to require that at least four of the minimum required college semester credits in biology shall be microbiology credits for a microbiology laboratory supervisor is too stringent and not necessary. During meetings of the LAAC, several members of the public in attendance as well as the LAAC members requested that the Department require, that in addition to four credits in microbiology, all laboratory supervisors shall have taken a microbiology laboratory course. After consideration of the public comments and after further discussion with the LAAC, the Department determined that requiring four credits of microbiology and not specifically requiring a laboratory course work is an acceptable compromise. Colleges and universities have many courses available online, and four microbiology credits can be obtained in a single course. An individual that proposes to supervise a microbiology laboratory needs the microbiology education obtained during a college-level microbiology course and four credits in microbiology. The techniques and methods included in the basic microbiology category are not limited to Colilert testing, as noted by several commentators. The basic microbiology category includes technologies such as membrane filtration, multiple tube fermentation and pour plate. These techniques require understanding and proficiency with sterile techniques, positive and negative controls, and specific media preparation and uses. The Department did not make changes in the microbiology supervisor sections from proposed rulemaking to final-form rulemaking.
Several commentators provided suggestions regarding the Department's proposal to require chemical preservation checks of all sample bottles received by the laboratory. The Department included this provision at the recommendation of the SDW Program and the EPA's instruction that an improperly collected sample is invalid and cannot be used for compliance purposes. Through discussions with the regulated community, the Department decided to limit the pH testing requirement to those samples that require a specific pH by method, regulation or permit, and all SDW compliance samples. This compromise will ensure the protection of the public health but reduce the financial burden for nondrinking water samples. The regulated community participating in the public meeting were amenable to the compromise. The Department also plans to develop technical guidance documents in collaboration with the LAAC to assist the regulated community in understanding the various options available to comply with the sample acceptance and handling requirements of the regulation.
Commentators also stated that the laboratory should not be required to develop sample handling, collection and preservation instructions if adequate documentation for these activities already exists. The Department agrees with these commentators and amends this final-form rulemaking to clarify that the laboratory shall maintain documentation of sample collection and preservation requirements. The laboratory may choose to develop its own or use currently published materials from another source.
A commentator asserted that the proposed language to segregate expired chemicals from unexpired chemicals should not be accepted and expired chemicals should be removed from the laboratory and discarded. The commentator also stated that the Department's allowance for recertification of expired chemicals, materials, and positive and negative controls should be deleted from §§ 252.306(h) and 252.404(h) (relating to equipment, supplies and reference materials; and essential quality control requirement—microbiology) because the use of expired materials does not improve the quality of the testing results. The proposed language for segregation of expired chemicals was a compromise made between the Department and the LAAC to allow laboratories to maintain expired chemicals for noncompliance purposes but to ensure that they could not be mistaken as acceptable for use for compliance testing. However, the Department agrees with the suggestion to delete the allowance for recertification of expired materials and deletes this provision from this final-form rulemaking.
G. Benefits, Costs and Compliance
Benefits
The most significant benefit of this final-form rulemaking is clear, concise and improved regulations for the regulated community. This final-form rulemaking will allow for better understanding and increased compliance with the requirements and thus result in an improvement in the overall quality of the data produced by environmental laboratories. All laboratories, particularly small laboratories, will benefit from allowing a laboratory supervisor to be absent for up to 21 days, rather than the current 16 days, and be replaced by a qualified staff member without requiring written notification to the Department. Several of the laboratory supervisor areas of experience qualifications were reduced from 2 years to 1 year. This final-form rulemaking deletes the requirement for the Department to conduct onsite assessments, thus allowing the Department to explore and employ advances in technology to perform offsite assessments which can substantially reduce overall costs to the Program and regulated laboratories.
This final-form rulemaking also adds some specific requirements for NELAP laboratories. The NELAC Institute (TNI) Standard, which NELAP laboratories shall meet, is silent or lacking in specific requirements for several necessary standards. Requiring that all NELAP laboratories adhere to these regulations will ensure that all laboratories performing testing or analysis of compliance samples for the Department are meeting the same minimum standard.
Improved data quality will allow the Department, the regulated community and the citizens of this Commonwealth to make better and more informed decisions concerning the protection of the environment and the protection of public health, safety and welfare. Accurate laboratory results are critical to achieving the goals of the environmental laws which are covered by the regulations.
Compliance costs
The direct costs of this final-form rulemaking is the payment of the accreditation fees. Chapter 41 of 27 Pa.C.S. requires that the fees be set in an amount sufficient to cover the cost of establishing and maintaining a laboratory accreditation program. These costs vary depending upon the type of testing and analyses that the environmental laboratory chooses to perform. Laboratories that require extensive staff time to accredit, such as large commercial laboratories and NELAP laboratories, will pay a higher accreditation fee.
The renewal fee for State accreditation is increased by $200 per year while the renewal fee for NELAP applicants is increased by $750 per year. Renewal application fees increase for all laboratories at a rate of approximately 30%. Each laboratory is also responsible for paying the appropriate category fee associated with its requested scope of accreditation, such as microbiology, trace metals, volatile organics, and the like. The total accreditation fee for each laboratory is the renewal application fee plus each appropriate category fee. Each category fee is increased by between $100—$200 depending on the complexity of each category. The fees for medium to large accredited laboratories are likely to increase by approximately 20%—30% depending on the requested scope of accreditation.
This final-form rulemaking includes a fee structure that is responsive to the needs of small laboratories. Specifically, increased accreditation costs for smaller laboratories will be minimal as the fees for the Basic Non-Potable Water and Basic Drinking Water fee categories increase by $300. The former annual fee paid by these environmental laboratories was $1,250, and the fee change will result in an annual fee of $1,550. Laboratories seeking accreditation for these two categories represent the majority of the applicant laboratories as well as the smallest of the regulated laboratories. In addition, the fee structure includes changes including separation of the microbiology category into ''basic'' and ''complex'' to ensure that laboratories that are performing more complex testing, which requires additional staff time and oversight, cover the costs of the accreditation. There were no public comments expressing objections to these increased fees.
Indirect costs will be related to the individual laboratory's implementation of the new requirements. Many in the regulated community are already in compliance with the additional requirements itemized in this final-form rulemaking and will not incur any additional costs for implementation. Others will be required to update or develop standard operating procedures and update recordkeeping procedures.
Cost savings will occur in the regulated community because the new and clarified requirements will enable laboratories to better understand the applicable requirements and should reduce the number of violations found during assessments, thus reducing the amount of time and money necessary to correct these violations.
Compliance assistance plan
Aside from the fee changes, the major changes that might require additional compliance assistance include the new requirements for sample collection instructions, sample receipt documentation and microbiology incubator temperature distribution studies. The Department plans to develop technical guidance in collaboration with the LAAC and the public. The other amendments in this final-form rulemaking are minor and in most cases clarify existing requirements or make former requirements less stringent. The Department does not believe that a compliance assistance plan tailored to these amendments is necessary. However, the Department will continue its ongoing compliance assistance efforts with mass e-mails, updates to its web site and other activities.
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. Compliance assistance in these areas has been made available to all environmental laboratories, regardless of size, throughout this Commonwealth.
Paperwork requirements
This final-form rulemaking does not include any additional forms, reports or other paperwork to be submitted.
H. Pollution Prevention
This is not applicable to this final-form rulemaking.
I. Sunset Review
The Board is not establishing a sunset date for these regulations since they are needed for the Department to carry out its statutory authority. The Department will continue to closely monitor these regulations for their effectiveness and recommend updates to the Board as necessary.
J. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P.S. § 745.5(a)), on July 29, 2016, the Department submitted a copy of the notice of proposed rulemaking, published at 46 Pa.B. 5088, 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, the Department shall submit to IRRC and the House and Senate Committees copies of 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 and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P.S. § 745.5a(j.2)), on June 14, 2017, 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 June 15, 2017, 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. 240) (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 proposed rulemaking published at 46 Pa.B. 5088.
(4) These regulations are necessary and appropriate for administration and enforcement of the authorizing acts identified in Section C of this final-form rulemaking.
L. Order
The Board, acting under the authorizing statutes, orders that:
(a) The regulations of the Department, 25 Pa. Code Chapter 252, are amended by amending §§ 252.1, 252.3, 252.4—252.6, 252.201, 252.203—252.206, 252.301, 252.302, 252.304, 252.306, 252.307, 252.401, 252.402, 252.404, 252.501, 252.601, 252.701—252.706 and 252.708 to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.
(Editor's Note: The amendments to § 252.365 were not included in the proposed rulemaking.)
(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 submit this order and Annex A to IRRC and the Senate and House Environmental Resources and Energy Committees as required under the Regulatory Review Act (71 P.S. §§ 745.1—745.14).
(d) The Chairperson of the Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau, as required by law.
(e) This order shall take effect immediately upon publication in the Pennsylvania Bulletin.
PATRICK McDONNELL,
Chairperson(Editor's Note: See 47 Pa.B. 3672 (July 1, 2017) for IRRC's approval order.)
Fiscal Note: Fiscal Note 7-495 remains valid for the final adoption of the subject regulations.
Annex A
TITLE 25. ENVIRONMENTAL PROTECTION
PART I. DEPARTMENT OF ENVIRONMENTAL PROTECTION
Subpart D. ENVIRONMENTAL HEALTH AND SAFETY
ARTICLE VI. GENERAL HEALTH AND SAFETY
CHAPTER 252. ENVIRONMENTAL LABORATORY ACCREDITATION
Subchapter A. GENERAL PROVISIONS § 252.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
* * * * * NELAP accreditation body—An accreditation body that has been recognized as meeting the requirements of the NELAC Standard or the TNI Standard and has the authority to grant NELAP accreditation.
* * * * * § 252.3. Scope.
(a) Environmental statutes. This chapter applies to facilities that test or analyze environmental samples in the matrices listed in subsection (b) for the purpose of complying with the following environmental statutes:
(1) 58 Pa.C.S. Chapter 32 (relating to development).
(2) The Clean Streams Law (35 P.S. §§ 691.1—691.1001).
(3) The Hazardous Sites Cleanup Act (35 P.S. §§ 6020.101—6020.1305).
(4) The Land Recycling and Environmental Remediation Standards Act (35 P.S. §§ 6026.101—6026.908).
(5) The Pennsylvania Safe Drinking Water Act (35 P.S. §§ 721.1—721.17).
(6) The Solid Waste Management Act (35 P.S. §§ 6018.101—6018.1003).
(7) The Storage Tank and Spill Prevention Act (35 P.S. §§ 6021.101—6021.2104).
(8) The Bituminous Coal Mine Safety Act (52 P.S. §§ 690-101—690-708).
(9) The Surface Mining Conservation and Reclamation Act (52 P.S. §§ 1396.1—1396.19b).
(10) The Coal Refuse Disposal Control Act (52 P.S. §§ 30.51—30.66).
(11) The Bituminous Mine Subsidence and Land Conservation Act (52 P.S. §§ 1406.1—1406.21).
(12) The Noncoal Surface Mining Conservation and Reclamation Act (52 P.S. §§ 3301—3326).
(b) Matrix. The following matrices are included:
(1) Drinking water.
(2) Nonpotable water.
(3) Solid and chemical materials.
(c) Exclusions. The following testing and analysis are specifically excluded from the requirements of this chapter:
(1) Corrosion protection system testing or testing of a storage tank system for tightness or structural soundness under Chapter 245 (relating to administration of the storage tank and spill prevention program).
(2) Routine release detection monitoring under §§ 245.442—245.445, 245.543 and 245.613.
(3) Analyses to determine the acceptability of soils for protective, daily, intermediate and final cover material, subbase, clay liner, clay cap, attenuating soil base and liner system construction material under Chapters 260a, 261a, 262a, 263a, 264a, 265a, 266a, 266b, 268a, 269a, 270a, 271—273, 275, 277, 279, 281, 283—285, 287—289, 291, 293, 295 and 297—299.
(4) Testing or analysis of the physical, chemical, mechanical and thermal properties of liners, liner systems, leachate detection zones and barriers under Chapters 260a, 261a, 262a, 263a, 264a, 265a, 266a, 266b, 268a, 269a, 270a, 271—273, 275, 277, 279, 281, 283—285, 287—289, 291, 293, 295 and 297—299.
§ 252.4. General requirements.
(a) Testing or analysis of environmental samples within a matrix identified in § 252.3 (relating to scope) and to comply with a statute listed in § 252.3 shall be performed by an environmental laboratory accredited under this chapter.
(b) An environmental laboratory testing, analyzing or reporting results for environmental samples in a matrix identified in § 252.3 and required by a statute identified in § 252.3 shall be accredited and in compliance with this chapter to generate data and perform analysis used to comply with an environmental statute listed in § 252.3.
§ 252.5. NELAP equivalency.
(a) An environmental laboratory may apply to the Department for NELAP accreditation for the fields of accreditation for which the Department offers accreditation.
(b) An environmental laboratory seeking NELAP accreditation shall:
(1) Submit a complete application as provided in Subchapter B (relating to application, fees and supporting documents).
(2) Comply with Subchapter E (relating to proficiency test study requirements).
(3) Comply with Subchapter F (relating to assessment requirements).
(4) Comply with Subchapter G (relating to miscellaneous provisions).
(5) Comply with the current edition of the NELAC Standard or TNI Standard.
(6) Comply with § 252.307 (relating to methodology).
(7) Comply with § 252.401 (relating to basic requirements).
(c) An environmental laboratory receiving NELAP accreditation from the Department may apply for accreditation under the remainder of this chapter for the fields of accreditation that are not included in NELAP accreditation and for which the Department offers accreditation.
(d) An environmental laboratory receiving NELAP accreditation from the Department may only test or analyze environmental samples within the fields of accreditation authorized by the accreditation received from the Department.
§ 252.6. Accreditation-by-rule.
(a) Purpose. Environmental laboratories performing testing or analysis or reporting results described in this section will be deemed to have accreditation-by-rule if the following general requirements are met:
(1) The environmental laboratory registers with the Department in accordance with 27 Pa.C.S. § 4107(a) (relating to interim requirements).
(2) The environmental laboratory performs the testing or analysis in conformance with applicable State or Federal laws, regulations, promulgated methods, orders and permit conditions.
(3) The environmental laboratory assures that samples for testing or analysis are properly preserved, are in proper containers, do not exceed maximum holding times between collection and analysis, and are handled in accordance with applicable State or Federal laws, regulations, promulgated methods, orders and permit conditions.
(4) The environmental laboratory has the other necessary permits under the applicable environmental protection acts and is operating under the acts and regulations promulgated thereunder and the terms and conditions of permits.
(5) Records pertaining to the testing or analysis of environmental samples are retained onsite and in accordance with § 252.706 (relating to recordkeeping). Records shall be made available to the Department upon request.
(6) The environmental laboratory is reporting only the results of the testing or analysis of environmental samples specified in subsections (c) and (f) in conformance with the applicable State or Federal laws, regulations, orders or permit conditions.
* * * * *
Subchapter B. APPLICATION, FEES AND SUPPORTING DOCUMENTS § 252.201. Application and supporting documents.
(a) An environmental laboratory seeking accreditation for one or more fields of accreditation within a matrix described in § 252.3 (relating to scope) or that seeks to add a field of accreditation shall apply to the Department for accreditation on forms provided by the Department and in the format specified by the Department. The applicant shall provide other relevant material requested by the Department.
(b) An application for accreditation must include the appropriate application fee in accordance with § 252.204 (relating to fees.)
(c) Environmental laboratories maintained on separate premises shall maintain distinct accreditation. Separate accreditation is not required for environmental laboratories in different buildings on the same or adjoining grounds, provided the laboratories are operated under the same management.
(d) Separate accreditation is required for a mobile laboratory.
§ 252.203. Accreditation renewal.
(a) Applications for accreditation renewal shall be submitted annually to the Department at least 60 calendar days prior to the expiration date of the current certificate of accreditation in writing on forms provided by the Department and in the format specified by the Department.
(b) An application for accreditation renewal must include the appropriate application fee in accordance with § 252.204 (relating to fees).
(c) Failure to submit an application for renewal in accordance with this section will result in a lapse in accreditation if the Department has not approved the renewal application prior to the expiration of the current certificate of accreditation. If a lapse in accreditation occurs, the environmental laboratory shall cease all testing or analysis of environmental samples for the affected fields of accreditation.
(d) Within 48 hours of expiration of the certificate of accreditation, the laboratory shall notify each of its customers affected by the expiration of the certificate of accreditation in writing of the lapse in accreditation. The Department may choose to require the laboratory to use specific language in the written notice or to require Department approval of the notice before issuance.
§ 252.204. Fees.
(a) The appropriate fee in accordance with the following schedule must accompany an application for accreditation, renewal of accreditation, change of ownership, change in administrative information, addition of fields of accreditation or supplemental onsite assessment. A check must be payable to ''Commonwealth of Pennsylvania.'' When the Department is able to accept credit card payments, an environmental laboratory may make payment by credit card and shall pay to the Commonwealth all service charges or other administrative fees in addition to the accreditation fees. The fees are as follows:
Category Fee Application fee—Initial Application for State Accreditation $1,500 Application fee—Renewal Application for State Accreditation $700 Application fee—Ownership Transfer or Change in Administrative Information $150 Application fee—Initial Application for NELAP Accreditation $3,500 Application fee—Renewal Application for NELAP Accreditation $2,750 Application fee—Addition of Field of Accreditation $350 Application fee—Supplemental Onsite Assessment $500 Basic Drinking Water Category—Includes one method for each of the following: Total Coliform Bacteria, Fecal Coliform Bacteria,
E. coli Bacteria, Heterotrophic Bacteria, Nitrate, Nitrite, Fluoride, Cyanide$750 Basic Nonpotable Water Category—Includes one method for each of the following: Fecal Coliform Bacteria, BOD, CBOD, Nitrate, Ammonia, Total Nitrogen, Total Kjeldahl Nitrogen, Nitrite, Phosphorus, and one method for each type of residue including % Solids for land applied biosolids $850 Asbestos—first matrix $600 Basic Microbiology—includes fecal coliform, total coliform, E. coli and heterotrophic bacteria—first matrix $700 Complex Microbiology—first matrix $1,000 Trace Metal Category—first matrix $750 Inorganic Nonmetal Category—first matrix $850 Purgeable Volatile Organic Chemicals—first matrix $850 Extractable and Semivolatile Organic Chemicals—first matrix $1,750 Dioxin—first matrix $850 Radiochemical Category—first matrix $950 Whole Effluent Toxicity Testing—first matrix $950 Asbestos—second matrix $450 Basic Microbiology—includes fecal coliform, total coliform, E. coli and heterotrophic bacteria—second matrix $600 Complex Microbiology—second matrix $900 Trace Metal Category—second matrix $600 Inorganic Nonmetal Category—second matrix $700 Purgeable Volatile Organic Chemicals—second matrix $700 Extractable and Semivolatile Organic Chemicals—second matrix $1,600 Dioxin—second matrix $700 Radiochemical Category—second matrix $850 Asbestos—third matrix $400 Basic Microbiology—includes fecal coliform, total coliform, E. coli and heterotrophic bacteria—third matrix $500 Complex Microbiology—third matrix $800 Trace Metal Category—third matrix $550 Inorganic Nonmetal Category—third matrix $650 Purgeable Volatile Organic Chemicals—third matrix $600 Extractable and Semivolatile Organic Chemicals—third matrix $1,450 Dioxin—third matrix $650 Radiochemical Category—third matrix $750 (b) At least every 3 years, the Department will recommend regulatory changes to the fees in this section to the EQB to address any disparity between the program income generated by the fees and program costs. The regulatory amendment will be based upon an evaluation of the accreditation program fees income and the Department's costs of administering the accreditation program.
(c) An environmental laboratory owned or operated by a Commonwealth agency is exempt from this fee requirement, but shall apply for accreditation under this chapter.
(d) Fees are nonrefundable.
(e) In addition to the nonrefundable application fee, an out-of-State environmental laboratory shall reimburse the Department for the costs associated with onsite assessments necessitated by accreditation as specified in § 252.206 (relating to out-of-State onsite reimbursement).
§ 252.205. Out-of-State laboratories.
(a) Out-of-State environmental laboratories may apply for primary accreditation or secondary accreditation from the Department.
(1) Primary accreditation. Out-of-State environmental laboratories may apply to the Department for primary accreditation under this chapter.
(2) Secondary accreditation.
(i) The Department will recognize accreditation granted by a primary NELAP accreditation body for the same fields of accreditation for which the Department is a primary NELAP accreditation body provided the environmental laboratory meets the requirements of § 252.5 (relating to NELAP equivalency).
(ii) The Department may recognize the accreditation of an environmental laboratory by another state accreditation body if the standards for accreditation are substantially equivalent to those established under this chapter and the laboratory is physically located within the state granting accreditation.
(iii) An environmental laboratory seeking secondary accreditation from the Department shall:
(A) Submit a properly completed application on forms provided by the Department.
(B) Pay the appropriate fee.
(C) Submit a copy of a valid accreditation certificate from the primary accreditation body.
(D) Submit a copy of all onsite assessment reports conducted by the primary accreditation body within the last 3 years.
(E) Submit any other material relevant to accreditation, upon request of the Department.
(b) The Department may conduct an onsite assessment or require analysis of a proficiency test study by an out-of-State environmental laboratory seeking secondary accreditation for reasons which may include addressing complaints from the public or Department personnel, discrepancies with environmental sample results, onsite assessment deficiencies, frequent errors in reporting data to the Department and suspicions of fraud regarding data quality. If the Department determines that an onsite assessment is required, the environmental laboratory shall pay the Department's travel costs associated with the onsite assessment in accordance with § 252.206 (relating to out-of-State onsite reimbursement).
(c) If any portion of the out-of-State environmental laboratory's accreditation is denied, revoked or suspended by the primary accreditation body, the laboratory's authorization to perform testing or analysis is automatically revoked for the same fields of accreditation.
§ 252.206. Out-of-State onsite reimbursement.
In addition to the nonrefundable application fee, an out-of-State environmental laboratory shall reimburse the Department for the following costs associated with onsite assessments necessitated by accreditation:
(1) Transportation costs, including airfare, mileage, tolls, car rental, public transportation and parking.
(2) Meals and lodging.
(3) Travel time for each assessor at a rate of $75/hour.
Subchapter C. GENERAL STANDARDS FOR ACCREDITATION § 252.301. Laboratory supervisor.
(a) The Department will consider the laboratory supervisor of an environmental laboratory as the individual listed on the laboratory's application for accreditation for which the Department has reviewed and approved the individual's qualifications.
(b) Testing, analysis and reporting of data by an environmental laboratory shall be under the direct supervision of a laboratory supervisor.
(c) The laboratory supervisor shall certify that each test or analysis is accurate and valid and the test or analysis was performed in accordance with all conditions of accreditation. A laboratory supervisor may certify a test or analysis by signing the final laboratory report. A laboratory may use other mechanisms to certify a test or analysis, provided the mechanism is documented in the laboratory quality manual.
(d) The laboratory supervisor shall ensure that the records required by this chapter are maintained.
(e) The Department may disqualify a laboratory supervisor who is responsible for the submission of inaccurate test or analysis results.
(f) The Department will disqualify a laboratory supervisor convicted of any crime or offense related to violations of State or Federal laws or regulations related to the provision of environmental laboratory services or reimbursement for the services.
(g) An environmental laboratory may appoint one or more laboratory supervisors for the appropriate fields of accreditation for which they are seeking accreditation.
(h) An environmental laboratory shall designate another staff member meeting the qualifications of a laboratory supervisor and who is approved by the Department as described in subsection (a) to temporarily perform this function when a laboratory supervisor is absent for a period of time exceeding 21 consecutive calendar days. If this temporary absence exceeds 30 consecutive calendar days, the environmental laboratory shall notify the Department in writing under § 252.708 (relating to reporting and notification requirements).
(i) An individual may not be the laboratory supervisor of more than one environmental laboratory without authorization from the Department. Circumstances to be considered in the decision to grant the authorization will include at least the following:
(1) The extent to which operating hours of the laboratories to be supervised overlap.
(2) The adequacy of supervision in each laboratory.
§ 252.302. Qualifications of the laboratory supervisor.
(a) A laboratory supervisor of an environmental laboratory engaged in chemical analysis of organics or metals, or both, shall have the following qualifications:
(1) A bachelor's degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering.
(2) At least 24-college semester credit hours in chemistry.
(3) At least 2 years of experience in the testing or analysis of environmental samples in representative inorganic and organic fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation. An earned master's or doctoral degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering may be substituted for 1 year of experience.
(b) A laboratory supervisor of an environmental laboratory engaged in inorganic nonmetals chemical analysis shall have the following qualifications:
(1) At least an earned associate's degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering, or 2 years of equivalent and successful college education.
(2) At least 16-college semester credit hours in chemistry.
(3) At least 1 year of experience in the testing or analysis of environmental samples in representative fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation.
(c) A laboratory supervisor of an environmental laboratory engaged in microbiological or biological analysis shall have the following qualifications:
(1) A bachelor's degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering.
(2) At least 16-college semester credit hours in biology. At least 4 of the 16-college semester credit hours must be in microbiology.
(3) At least 2 years of experience in the testing or analysis of environmental samples in representative microbiological or biological fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation. A master's or doctoral degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering may be substituted for 1 year of experience.
(d) A laboratory supervisor of an environmental laboratory engaged in microbiological analysis limited to fecal coliform, total coliform, E. coli and heterotrophic bacteria shall have the following qualifications:
(1) At least an associate's degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering.
(2) A minimum of 4-college semester credit hours in microbiology.
(3) At least 2 years of equivalent and successful college education, including a minimum of 4-college semester credit hours in microbiology may be substituted for the associate's degree.
(4) At least 1 year of experience in the testing or analysis of environmental samples in representative fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation.
(e) A laboratory supervisor of an environmental laboratory engaged in radiological analysis shall have the following qualifications:
(1) A bachelor's degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering.
(2) At least 24-college semester credit hours in chemistry or health physics.
(3) At least 2 years of experience in the testing or analysis of environmental samples in representative radiological fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation. An earned master's or doctoral degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering may be substituted for 1 year of experience.
(f) A laboratory supervisor of an environmental laboratory engaged in microscopic examination of asbestos or airborne fibers shall have the following qualifications:
(1) For procedures requiring the use of a transmission electron microscope, a bachelor's degree, successful completion of formal course work in the use of the instrument and 1 year of experience, under supervision, in the use of the instrument. The experience must include the identification of minerals.
(2) For procedures requiring the use of a polarized light microscope, an associate's degree or 2 years of college study, successful completion of formal coursework in polarized light microscopy and 1 year of experience, under supervision, in the use of the instrument. The experience must include the identification of minerals.
(3) For procedures requiring the use of a phase contrast microscope, an associate's degree or 1 year of college study, documentation of successful completion of formal coursework in phase contrast microscopy and 1 year of experience, under supervision, in the use of the instrument.
(g) Notwithstanding any other provision of this section, a laboratory supervisor of an environmental laboratory limited to the basic nonpotable water category or the basic drinking water category shall have the following qualifications:
(1) At least 16-college semester credit hours in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering.
(2) At least 1 year of experience in the testing or analysis of environmental samples in representative fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation.
(h) Notwithstanding any other provision of this section, an employee of a drinking water, wastewater or industrial waste treatment facility meeting the following requirements will be deemed qualified as a laboratory supervisor of an environmental laboratory:
(1) The employee holds a valid treatment plant operator's certificate under the Water and Wastewater Systems Operators' Certification Act (63 P.S. §§ 1001—1015.1) in the appropriate water or wastewater subclassification for the facility.
(2) The employee holds a valid certificate under the Water and Wastewater Systems Operators' Certification Act for laboratory supervisor in the appropriate water or wastewater subclassification.
(3) At least 1 year of experience in the testing or analysis of environmental samples in representative fields of accreditation for which the environmental laboratory seeks to obtain or maintain accreditation.
(i) Approval as a laboratory supervisor under subsection (h) will be limited to the fields of accreditation required by the scope of that facility's regulatory permit.
(j) A laboratory supervisor of an environmental laboratory engaged in whole effluent toxicity analysis shall have the following qualifications:
(1) At least an associate's degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering.
(2) A minimum of 4-college semester credit hours in biology.
(3) At least 2 years of equivalent and successful college education, including a minimum of 4-college semester credit hours in biology may be substituted for the associate's degree.
(4) At least 2 years of experience in the testing or analysis of environmental samples in representative fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation.
(k) College semester credit hours shall be obtained from an accredited college or university recognized by the United States Department of Education.
(l) Foreign transcripts must be translated into English and evaluated for United States semester credit hour equivalency by a credential evaluation agency accredited by the National Association of Credentials Evaluation Services or a Department of Education approved agency.
(m) If a method, regulation or program requires more stringent qualifications for education or experience, or both, the laboratory shall meet the more stringent requirement.
§ 252.304. Personnel requirements.
(a) General requirements for technical staff.
(1) An environmental laboratory shall have sufficient personnel with the necessary education, training, technical knowledge and experience for their assigned functions.
(2) Each member of the environmental laboratory technical staff shall be responsible for complying with quality assurance and quality control requirements that pertain to the member's organizational or technical function.
(3) Each environmental laboratory technical staff member shall have a combination of experience and education to adequately demonstrate a specific knowledge of the member's particular function and a general knowledge of laboratory operations, test methods, quality assurance and quality control procedures and records management.
(4) If a method, regulation or program requires more stringent qualifications for education or experience, or both, the laboratory technical staff shall meet the more stringent requirement.
(b) Laboratory management responsibilities. The environmental laboratory management shall be responsible for:
(1) Defining the minimal level of qualification, experience and skills necessary for all positions or work cells in the environmental laboratory.
(2) Ensuring and documenting that the environmental laboratory technical staff members or work cells have demonstrated capability in the activities for which they are responsible. This documentation must include:
(i) An identification of the analysts involved in the preparation or analysis, or both.
(ii) The sample matrix.
(iii) The analyte, class of analyte or measured parameter.
(iv) An identification of the test method performed.
(v) An identification of the laboratory-specific standard operating procedure used for analysis, including revision number and effective date.
(vi) The dates of preparation or analysis, or both.
(vii) The summary of analyses, including results.
(3) Ensuring and documenting that the training and competency of each member of the environmental laboratory technical staff is kept up to date by maintaining records demonstrating the following:
(i) That each employee has read, understood and is using the latest version of the environmental laboratory's quality manual that relates to each employee's job responsibilities.
(ii) That each employee has read, understood and is using the latest versions of the environmental laboratory's standard operating procedures that relate to each employee's job responsibilities.
(iii) Participation in training courses or workshops on specific equipment, analytical techniques or laboratory procedures that relate to each employee's job responsibilities.
(iv) Participation in training courses in ethical and legal responsibilities including the potential liabilities for improper, unethical or illegal actions.
(v) That each employee has read, understood and acknowledged his personal ethical and legal responsibilities including the potential punishments and penalties for improper, unethical or illegal actions.
(vi) An initial demonstration of capability for each method that relates to the employee's job responsibilities has been performed. The initial demonstration of capability requirements are as follows:
(A) An initial demonstration of capability is required prior to the use of any method.
(B) An initial demonstration of capability shall be completed each time there is a change in instrument type, personnel or method.
(C) An initial demonstration of capability must include all sample preparation and analytical steps contained in the method.
(D) If the method or State or Federal regulations specify a procedure for the initial demonstration of capability, that procedure shall be followed; otherwise, an initial demonstration of capability shall be performed as follows:
(I) The analyte shall be diluted in a volume of clean matrix sufficient to prepare four aliquots at the concentration specified in the method. If the method does not specify a concentration, the concentration must be in the lower half of the calibration range or at or below the maximum contaminant level for Safe Drinking Water Act compliance testing, whichever is lower.
(II) At least four aliquots of the quality control sample shall be prepared and analyzed consecutively according to the method. The preparation or analysis, or both, may occur on a single day or over the course of multiple days.
(III) Using all of the results, calculate the individual recovery, the mean recovery and the standard deviation of the mean recovery for the population sample in the same units used to report environmental samples. When it is not possible to determine mean and standard deviation, such as for presence-absence and logarithmic values, the environmental laboratory shall assess method performance using criteria from the method or other established and documented criteria.
(IV) Compare the information from subclause (III) to the corresponding acceptance criteria for precision and accuracy in the method. If the method or regulation does not specify acceptance limits, the % Relative Standard Deviation must be less than 20%. To be considered acceptable, an initial demonstration of capability must meet all acceptance criteria.
(E) When a method has been in use by an environmental laboratory prior to January 1, 2005, and there have been no changes in instrument type, personnel or method, the environmental laboratory shall have records on file to demonstrate that an initial demonstration of capability is not required.
(F) The laboratory shall retain all data necessary to reproduce the initial demonstration of capability.
(G) The work cell as a unit shall meet the following requirements:
(I) When a member of a work cell changes, the new work cell shall demonstrate capability by means of acceptable quality control performance checks on four consecutive batches. The acceptable performance shall be documented. If any quality control performance check within the four consecutive batches following the change in personnel fails to meet acceptance criteria, an initial demonstration of capability shall be completed.
(II) If the entire work cell is changed, an initial demonstration of capability shall be completed.
(vii) A demonstration of continued proficiency by at least one of the following every 12 months for each method that relates to the employee's job responsibilities:
(A) Another initial demonstration of capability.
(B) Acceptable performance of blind performance samples (single blind to the analyst).
(C) Successful analysis of blind proficiency test samples on a similar test method using the same technology (for example—GC/MS volatiles by purge and trap for EPA Methods 524.2, 624 or 5030/8260 would require documentation for only one of the test methods).
(D) At least four consecutive laboratory control samples with acceptable levels of precision and accuracy as required by the initial demonstration of capability described in subparagraph (vi).
(E) Analysis of at least ten authentic samples with results statistically indistinguishable from those obtained by another trained analyst. The samples must include samples free of the analyte of interest and samples containing the analyte of interest at measurable concentrations.
(4) Supervising personnel employed by the laboratory.
(5) Establishing and implementing procedures and processes for permitting departures from documented policies and procedures.
(6) Ensuring that sample acceptance criteria are verified and that samples are logged into the sample tracking system and properly labeled and stored.
(7) Developing a proactive program for prevention and detection of improper, unethical or illegal actions. Components of this program may include the following:
(i) Internal proficiency testing (single and double blind).
(ii) Postanalysis electronic data and magnetic tape audits or reviews.
(iii) Separate standard operating procedures identifying appropriate and inappropriate laboratory and instrument manipulation practices.
(c) An environmental laboratory shall maintain records on initial demonstrations of capability, demonstrations of continued proficiency, proficiency test samples for each laboratory method and the qualifications, training, skills and experience of the laboratory technical staff members.
§ 252.306. Equipment, supplies and reference materials.
(a) An environmental laboratory shall be furnished with all items of equipment, including reference materials, required for the correct performance of tests or analyses for which accreditation is sought.
(b) An environmental laboratory shall maintain records of each item of equipment significant to the testing or analysis performed. These records must include documentation on the following:
(1) The name of the item of equipment.
(2) The manufacturer's name, type identification, and serial number or other unique identification.
(3) The date received and date placed in service (if available).
(4) The current location, when appropriate.
(5) If available, condition when received (for example, new, used or reconditioned).
(6) A copy of the manufacturer's instructions, when available.
(7) The dates and results of calibrations or verifications.
(8) The manufacturer's instructions, if available, or reference their location.
(9) The details of maintenance performed.
(10) A history of damage, malfunction, modification or repair.
(c) An environmental laboratory shall assure that the test instruments and all equipment, supplies and reference materials consistently operate within and meet the specifications required of the application for which it is used.
(d) Equipment shall be properly maintained, inspected and cleaned.
(e) Any item of equipment that has been subjected to overloading, mishandling, gives suspect results or has otherwise been shown to be defective, shall be taken out of service and clearly identified until it has been repaired and shown by calibration, verification or test to perform satisfactorily. The laboratory shall examine the effect of this defect on previous testing or analysis.
(f) The following pieces of equipment shall be maintained according to this subsection.
(1) Certified NIST-reference thermometer.
(i) A certified NIST-reference thermometer must have appropriate graduations and a range that spans the requirements of the method.
(ii) The certified NIST-reference thermometer shall be recalibrated at least once every 5 years at the temperatures of use.
(iii) An environmental laboratory shall retain a certificate documenting traceability of the calibration to NIST standards.
(2) Working thermometers.
(i) Working thermometers must have appropriate graduations and a range that spans the requirements of the method.
(ii) Working thermometers may be glass, dial or electronic and shall be calibrated against a certified NIST-reference thermometer as follows:
(A) Glass, liquid filled thermometers shall be calibrated every 12 months at the temperature used.
(B) Dial and electronic thermometers shall be calibrated every 3 months at the temperature used. Electronic thermometers accompanied by a valid NIST traceable certificate of acceptance may be used for 12 months from the date of receipt before recalibration.
(C) An environmental laboratory shall maintain records in a laboratory notebook for each working thermometer that document the date of calibration, NIST reference thermometer identification, working thermometer identification, reference thermometer temperature reading, working thermometer temperature reading, correction factor and the initials of the individual conducting the calibration.
(D) Working thermometers shall be uniquely identified and labeled with the date of calibration and correction factor.
(iii) The fluid column in glass thermometers may not be separated.
(iv) A working thermometer that differs by more than 2.0°C from the reference thermometer may not be used.
(3) ASTM class 1, 2 or 3 (Class S or S-1), or better certified reference weights.
(i) The mass of ASTM class 1, 2 or 3 (Class S or S-1), or better certified reference weights shall be recertified at least once every 5 years.
(ii) An environmental laboratory shall retain a certificate documenting traceability of the calibration to ASTM standards.
(4) Analytical or pan balances.
(i) Analytical or pan balances must provide sufficient accuracy and sensitivity for the weighing needs of the method.
(ii) An environmental laboratory shall verify the calibration of a balance daily or before each use, whichever is less frequent.
(iii) A reference weight that is damaged or corroded may not be used for calibration of balances.
(iv) Balance calibration shall be verified using a minimum of three ASTM class 1, 2 or 3 (Class S or S-1) certified reference weights that bracket the effective range of the balance's use.
(v) An environmental laboratory shall maintain records in a laboratory notebook of balance calibrations and verifications that document the balance identification, date of calibration, date of verification, reference weights used, observed measurement and initials of the individual performing the calibration verification.
(vi) A qualified person shall service and calibrate analytical balances at least once per year.
(vii) Records of annual service shall be maintained and the service date shall be recorded on the balance.
(5) pH meter.
(i) A pH meter must be equipped with an appropriate electrode and have scale graduators and accuracy appropriate to the method.
(ii) An environmental laboratory shall utilize either a thermometer or a temperature sensor for automatic compensation to make corrections for pH measurements.
(iii) The pH meter shall be calibrated daily or before each use, whichever is less frequent, by one of the following:
(A) With at least three standard buffers which are at least three pH units apart.
(B) Use a pH 7.0 and either a pH 4.0 or 10.0 standard buffer, whichever range covers the desired pH range of use.
(iv) Aliquots of standard buffers may not be used for longer than 1 analysis day.
(v) Records of pH meter calibration shall be maintained in a laboratory notebook that document the date of calibration, calibration buffers used, results of the calibration, results of the calibration verification and initials of the individual conducting the calibration.
(6) Conductivity meter.
(i) A conductivity meter must have a probe of sufficient sensitivity for the method. The scale must have readability in appropriate units, for example micromhos or microsiemens per centimeter.
(ii) An in-line conductivity meter that cannot be calibrated may not be used.
(iii) An environmental laboratory shall calibrate the conductivity meter daily or before each use whichever is less frequent, by one of the following:
(A) With certified and traceable standard solutions within the range of interest.
(B) By determining the cell constant utilizing the method described in currently approved editions of Standard Methods for the Examination of Water and Wastewater (available from American Public Health Association, 1015 Fifteenth Street, NW, Washington, D.C. 20005.)
(iv) Records of conductivity meter calibrations shall be maintained in a laboratory notebook that documents the date of calibration, standards used, results of calibration or cell constant determined and the initials of the individual conducting the calibration.
(7) Refrigeration equipment and freezers.
(i) An environmental laboratory shall maintain one thermometer immersed in liquid (except electronic thermometers) to the appropriate immersion line for each refrigerator or freezer. The thermometer must be graduated in increments no larger than 1°C.
(ii) Calibration-corrected temperatures for each refrigerator and freezer shall be recorded once a day for each working day in use for all laboratory activities. The date, refrigerator or freezer identification, calibration corrected temperature and initial of responsible individual shall be recorded.
(iii) Samples and standards shall be stored in separate refrigerators where the potential for cross-contamination exists.
(iv) Samples which require thermal preservation shall be stored at a temperature which is ± 2°C of the specified preservation temperature unless method specific criteria exist. For samples with a storage temperature of 4°C, storage at a temperature of 0.5°C to 6°C is acceptable.
(v) Freezer temperatures must be less than 0°C.
(8) Incubators, water baths, heating blocks and ovens.
(i) An environmental laboratory shall control and monitor the temperature of incubators, water baths, heating blocks and ovens in accordance with the method or as specified by regulations.
(ii) An environmental laboratory shall maintain a minimum of one thermometer per incubator, water bath, heating block or oven immersed in liquid or sand for ovens (except electronic thermometers) to the appropriate immersion line. When used as an incubation unit for microbiology, a minimum of one working thermometer shall be on the top and bottom shelf of the use area in each incubator.
(iii) When used as an incubation unit for microbiology, a water bath must be equipped with a gable cover and a pump or paddles to circulate the water.
(iv) Calibration-corrected temperatures for each incubator, water bath, heating block or oven shall be recorded once a day for each working day in use for all laboratory activities. When used as an incubation unit for microbiology, the calibration-corrected temperature shall be recorded at least twice per day each day the incubator is in use with the readings separated by at least 4 hours. The incubator, water bath, heating block or oven identification, date, time, calibration corrected temperature and the initials of the responsible individual shall be recorded.
(9) Volumetric dispensing devices.
(i) Except for Class A glassware and glass microliter syringes, volumetric dispensing devices, including graduated cylinders, pipettes and burettes, must be of sufficient sensitivity for the application and the environmental laboratory shall verify and document the accuracy of the volume of use for each lot or at least once per year, whichever is more frequent. Delivery volumes of mechanical volumetric dispensing devices such as mechanical pipettes, autopipetors and dilutors shall be checked at least once every 3 months.
(ii) Verification will be considered acceptable if the accuracy of the volumetric dispensing device is within 2.5% of expected values. Volumetric dispensing devices that do not meet this criterion may not be used.
(10) Graduated sample containers.
(i) Except for Class A glassware, when graduation marks on filter funnels, sample bottles or labware are used to measure sample volume or prepare standards or reagents, an environmental laboratory shall verify and document the accuracy of the volume of use for each lot or at least once per year, whichever is more frequent.
(ii) Verification will be considered acceptable if the accuracy of the graduated sample container is within 2.5% of expected values. Graduated sample containers that do not meet this criterion may not be used to measure sample volumes.
(g) An environmental laboratory shall maintain records for all reference materials, reagents, laboratory supplies that are essential to obtain analytical results and support services utilized by the laboratory for testing or analysis.
(h) Reference materials, reagents, media and laboratory supplies that are essential to obtain analytical results (such as filters, solid-phase extraction disks/cartridges, presterilized filtration units, certified precleaned laboratory supplies, disposable volumetric equipment, prepreserved sample containers) must meet the following minimum requirements:
(1) Analytical reagent grade chemicals or equivalent are acceptable, unless a method specifies other reagent purity grade requirements.
(2) Standard, reagent, media and laboratory supply receipt records shall be maintained. These records must include vendor, lot number, amount received, date of receipt, expiration date and certificates of analysis or purity, if available.
(3) Purchased chemicals, solutions, standards, media and laboratory supplies shall be labeled with date of receipt, expiration date and the date when the container is opened. Purchased chemicals, solutions and standards without an expiration date on the original container shall be discarded after 10 years from the date of receipt.
(4) An environmental laboratory shall maintain records of standard, reagent and media preparation. Standard, media and reagent preparation records must contain identification of the compound, manufacturer, lot number, concentration, amount prepared, date prepared, final pH if used for microbiology testing, initials of the individual preparing the solution and expiration date.
(5) Reagent, media and standard solution containers shall be labeled with identification of the compound, traceability to the preparation record, such as unique identifier, and expiration date.
(6) Standards, reagents and media may not be used past the date of expiration. Expired reagents, standards and media shall be segregated from unexpired laboratory materials in a manner that ensures they are not used for the testing of environmental samples.
(7) Reagents, standards and media shall be checked regularly for signs of decomposition and evaporation. Reagents, standards and media exhibiting signs of decomposition or evaporation shall be discarded.
(8) When reagents, standards and media are removed from a container, the amount removed shall be used entirely or the unused portion discarded.
(9) Compressed gases must be of commercial grade, unless a method specifies other requirements.
(i) Plastic and glassware shall be cleaned to meet the sensitivity of the test method. Any cleaning and storage procedures that are not specified by the method shall be documented in a laboratory standard operating procedure.
(j) Except for circulating water baths, the laboratory shall perform temperature distribution studies for incubators that are used as incubation units for microbiology. The laboratory shall perform a temperature distribution study for each incubator prior to first use, after repair and every 3 years by the following procedure:
(1) The laboratory shall develop a procedure to determine the temperature distribution and fluctuations within an incubator. The laboratory shall take into account the size of the incubator (height, width and depth), number of shelves and type of incubator when developing the procedure to perform the temperature distribution study.
(2) At a minimum, the laboratory shall monitor and record the temperature of each shelf.
(3) Incubators that do not maintain constant temperatures within the acceptable temperature range for the application may not be used. The laboratory may establish procedures to limit incubator use to specific shelves or areas of the incubator that can be verified to maintain acceptable temperature fluctuations.
§ 252.307. Methodology.
* * * * * (i) When a method specifies a validation procedure, the validation procedure shall be completed before environmental samples may be analyzed and reported. The results of this validation procedure shall be documented and kept on file for the duration of use of the method and for at least 5 years after the method is no longer in use.
(j) An environmental laboratory shall maintain instructions for sample collection and preservation that meet the requirements of subsections (f) and (g).
(1) The environmental laboratory's instructions must accurately reflect all aspects of the sample collection and preservation requirements for the particular analyses, including the following:
(i) Container type, size and number of containers or bottles.
(ii) Sample collection method, amount of sample required and explanation of other specific requirements for sample collection such as ''zero headspace'' and ''first draw.''
(iii) Chemical preservation, including type of preservation and the procedure used to preserve the sample.
(iv) Thermal preservation, including the temperature requirements and procedure used to preserve the sample.
(v) Field blank requirements.
(vi) Holding time.
(2) The environmental laboratory shall make the sample collection and preservation instructions available to all laboratory sample collection personnel and to customers and clients that collect samples.
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