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Ohio Administrative Code (Last Updated: January 12, 2021) |
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3745 Ohio Environmental Protection Agency |
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Chapter3745-300. Voluntary Action Program |
3745-300-04. Certified laboratories
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[Comment: For dates of non-regulatory government publications, publications of recognized organizations and associations, federal rules, and federal statutory provisions referenced in this rule, see rule 3745-300-15 of the Administrative Code titled "Incorporation by reference - voluntary action program."]
(A) Certified data; authority of a certified laboratory to perform analyses.
(1) A certified laboratory produces certified data under affidavit in accordance with rule 3745-300-13 of the Administrative Code only when the analyses are performed within the laboratory's current certification. Certification may limit the analysis of certain environmental media, as indicated on the laboratory's certificate issued by Ohio EPA under this chapter.
(2) In order to produce certified data to support a voluntary action under this chapter and Chapter 3746. of the Revised Code, the following shall occur:
(a) The laboratory shall be certified for each analyte, parameter group, and method at the time the laboratory performs the analyses.
(b) The laboratory's analyses shall remain consistent with the laboratory's standard operating procedures (SOPs) and quality assurance program plan (QAPP).
(c) The laboratory's SOPs and QAPP used to produce certified data shall be consistent with all of the following:
(i) Requirements in the published method published or endorsed by U.S. EPA.
(ii) The applicable minimum requirements in paragraph (G) of this rule.
(iii) Any additional requirements specified during approval for analysis using performance-based methods under paragraph (B)(1)(c) of this rule.
(iv) Where there is a conflict between paragraph (A)(2)(c)(i) of this rule and paragraph (A)(2)(c)(ii) of this rule or paragraph (A)(2)(c)(iii) of this rule, requirements consistent with paragraph (A)(2)(c)(ii) of this rule or paragraph (A)(2)(c)(iii) of this rule take precedence.
(3) Certification pursuant to this rule is applicable to analyses performed in support of a voluntary action, including but not limited to the issuance of a no further action letter under this chapter and Chapter 3746. of the Revised Code. Certification pursuant to this rule does not constitute certification under any other state or federal laboratory certification or accreditation program.
(4) For certification obtained that relies on third-party accreditation, the certified laboratory shall maintain in good standing the accreditation provided in paragraphs (B)(1)(d) and (B)(1)(e) of this rule.
(5) A volunteer may request that a certified laboratory analyze the constituents of a hazardous substance when a chemical testing method or technology does not exist to measure the concentration of the hazardous substance. When a hazardous substance is comprised of more than one constituent, the certified laboratory shall obtain certification for each constituent, even if the constituent is not listed as a hazardous substance.
(6) If a certified laboratory no longer intends to retain certification, the certified laboratory may return the certificate with a notice by certified mail to Ohio EPA that indicates the certified laboratory's intent to withdraw from certification. Upon withdrawal, the laboratory shall not report data as certified data under this chapter.
(B) Methods for the analysis of analytes or parameter groups are the following:
(1) A laboratory may apply for certification pursuant to this rule for any method used for the analysis of any analyte or parameter group that meets the following criteria, except as provided in paragraph (B)(2) of this rule:
(a) Certification is restricted to hazardous substances or petroleum. If a chemical testing method or technology does not exist to measure the concentration of the hazardous substance, then certification to test for constituents of the hazardous substance may be granted pursuant to paragraph (A)(5) of this rule.
(b) Chemical testing methods. A laboratory may apply for certification for any chemical testing method published or endorsed by U.S. EPA. A laboratory shall use a published or endorsed method only in the manner for which that method is designed.
(c) Performance-based methods. At the request of a laboratory, Ohio EPA may evaluate whether to certify a laboratory to perform analyses using a performance-based method. A laboratory shall demonstrate the laboratory's ability to perform the method using a proficiency testing sample as provided in paragraph (C)(1) of this rule, if available, and in accordance with the application requirements in paragraph (D)(4) of this rule.
(d) Asbestos accreditations. A laboratory that applies for certification for the analysis of asbestos shall have current accreditation in at least one of the following programs:
(i) American industrial hygiene association, asbestos analysts registry.
(ii) National institute of standards technology, national voluntary laboratory accreditation program for asbestos fiber analysis.
(iii) "The NELAC Institute" (TNI) recognized accreditation body.
(e) "National Environmental Laboratory Accreditation Program" (NELAP) accreditation. A laboratory that applies for certification of the analysis of any constituent other than asbestos may rely on current NELAP accreditation from an accreditation body that is recognized by TNI.
(2) Testing for characteristic hazardous waste or for radioactive materials is not included for certification under this rule.
[Comment: Ohio EPA coordinates with the Ohio department of health for the Ohio department of health's review of any release of radioactive materials or substances.]
(3) Testing for sediment toxicity is not included for certification under this rule. Testing for sediment toxicity shall be performed in accordance with paragraph (F)(4)(b) of rule 3745-300-09 of the Administrative Code.
(C) Proficiency testing program.
(1) Use of proficiency testing samples; requirement to purchase proficiency testing samples through proficiency testing providers:
(a) Unless otherwise exempt from this requirement, a laboratory that applies for certification under this rule shall do the following:
(i) Analyze proficiency testing samples representative of the analytes or parameter groups for certification.
(ii) Receive from the proficiency testing provider acceptable proficiency testing results pursuant to the criteria of this rule.
(b) The laboratory shall order proficiency testing samples from a proficiency testing provider that is approved to produce the proficiency testing samples and evaluate the proficiency testing results.
(c) For the purposes of this rule, a laboratory shall analyze a proficiency testing sample that was formulated and evaluated using the criteria established by TNI.
(i) If the laboratory applies for certification for testing aqueous samples, the laboratory shall analyze a non-potable water sample or, if a non-potable water sample is not available, a drinking water sample.
(ii) If the laboratory applies for certification for testing solid matrix samples, the laboratory shall analyze a solid matrix sample or, if a solid matrix sample is not available, an aqueous sample.
(d) Paragraph (C)(1) of this rule does not apply to certifications for asbestos or to the circumstances provided in paragraph (C)(2) of this rule.
(2) Criteria for analysis of proficiency testing samples, exceptions, and waivers. To demonstrate compliance with this rule for any analyte or parameter group a laboratory shall analyze proficiency testing samples, which a proficiency testing provider prepared and evaluated using TNI criteria, except as follows:
(a) When a non-potable water proficiency testing sample is not available for an analyte or parameter group for which the laboratory applies for certification, proficiency testing samples prepared and evaluated based on drinking water criteria may be used instead.
(b) For mobile laboratories, each proficiency testing sample shall be analyzed while the laboratory is mobilized on location for a project and not at the laboratory's base of operations.
(c) For any analyte or parameter group for which TNI has not published any proficiency testing criteria or for which proficiency testing samples are not available, Ohio EPA may waive the proficiency testing sample analysis requirement in paragraph (C)(2) of this rule. In the case of a waiver, certification for the analyte or parameter group shall be limited to the use of a performance-based method as described in paragraph (B) (1)(c) of this rule.
(d) For any analyte or parameter group for which the laboratory holds NELAP accreditation in good standing pursuant to paragraph (B)(1)(e) of this rule, analysis of proficiency testing samples is not required unless Ohio EPA determines that proficiency testing is required.
(3) Use of existing proficiency testing results. A laboratory may use the proficiency testing results obtained for another state or federal certification or accreditation program to demonstrate compliance with this rule, provided that the proficiency testing samples comply with this rule.
(4) Analysis of proficiency testing samples.
(a) The laboratory shall analyze proficiency testing samples that include the analyte or parameter group which corresponds to the scope of the laboratory's certification or application for certification.
(b) The laboratory may analyze a proficiency testing sample on more than one technology to demonstrate proficiency for an analyte or parameter group and method. For example, a laboratory that applies for certification for volatile organic compounds by gas chromatography and mass spectrometry may analyze the same proficiency testing sample on both technologies.
(c) Analysis of proficiency testing samples shall be conducted in accordance with the laboratory's SOPs and QAPP identified in paragraph (D) of this rule.
(d) The ordering and analysis of proficiency testing samples is based on a technology. To comply with this rule, a laboratory shall order a proficiency testing sample based on the technology that is representative of the certification. For example, to encompass the scope of a certification for volatile organic compounds, the laboratory shall ensure that the proficiency testing sample contains both aromatics and halocarbons.
(5) Reporting and time lines for proficiency testing studies are as follows:
(a) Reporting proficiency testing results. A laboratory that is certified or that applies for certification for multiple technologies for an analyte or parameter group shall analyze and report proficiency testing results for each technology, and may use the same proficiency testing sample. For example, the same volatile organic compound proficiency testing sample may be analyzed on gas chromatography and mass spectrometry with a separate result reported for each technology.
(b) Time lines for the analysis of proficiency testing samples. A laboratory that applies for any initial or additional certification under this rule shall analyze the proficiency testing sample within the six months prior to the date the laboratory submits the laboratory's application, except as provided in paragraph (C)(2)(c) of this rule.
(c) After a laboratory received certification, Ohio EPA may use periodic performance testing to assess a laboratory's ability to perform testing under this rule. Upon request, laboratories shall analyze proficiency testing samples and shall report the results to Ohio EPA.
(6) Provide proficiency testing reports to Ohio EPA. A laboratory shall submit proficiency testing reports to Ohio EPA as follows:
(a) Applications for initial or additional certification. A laboratory that applies for initial or additional certification shall submit to Ohio EPA a copy of each required proficiency testing report with the documentation listed in paragraph (D)(1) of this rule.
(b) Proficiency testing report content. Each proficiency testing report submitted to Ohio EPA shall include of the following:
(i) Name of proficiency testing provider.
(ii) Laboratory name and address.
(iii) Opening and closing dates of the proficiency testing study.
(iv) Date proficiency testing report was issued.
(v) Analyte or parameter group with units, reported value, assigned value, and acceptance limits.
(vi) Performance evaluation by proficiency testing provider.
(vii) Technology code or method description.
(viii) Sample matrix type.
(7) Ohio EPA evaluation of proficiency testing results. A laboratory that applies for initial or additional certification or renewal certification shall meet the proficiency testing requirements as follows:
(a) The proficiency testing samples are acceptable for use based on the criteria provided in this rule for the analyte or parameter group for which the laboratory applies for certification.
(b) The laboratory obtained acceptable proficiency testing results for each analyte and parameter group using the methods and technologies, including matrix type, for which the laboratory applies for certification.
(c) The laboratory submitted to Ohio EPA the proficiency testing report for proficiency testing samples analyzed within the time frame provided in paragraph (C) of this rule.
(d) Ohio EPA may require a laboratory that applies for certification for a performance-based method to analyze proficiency testing samples. These proficiency testing results shall be used to evaluate a laboratory's qualifications to apply for the performance-based method. For example, a laboratory that applies for initial or additional certification for n-Hexane by gas chromatography and mass spectrometry shall provide acceptable proficiency testing results for a non-potable water volatile proficiency testing sample analyzed using the same technology and method.
(D) Procedures to apply for initial, additional, or renewal certification.
(1) Applications for initial or additional certification. To apply for initial or additional certification, a laboratory shall submit the following, in the format prescribed by Ohio EPA:
(a) The completed original application for initial certification or additional certification, including the affidavit, signed by a person authorized to submit the affidavit on behalf of the laboratory, affirming, based upon knowledge, information, and belief, that all information provided in the application and associated documentation is true, accurate, and complete. The applications shall be on the form provided by Ohio EPA.
(b) The laboratory's QAPP that complies with paragraph (G) of this rule.
(c) The laboratory's proficiency testing report, in accordance with paragraph (C) of this rule, for the analytes and parameter groups for which the laboratory applies for certification. This requirement does not apply to asbestos, or when proficiency testing samples are not required as described in paragraph (C)(2) of this rule.
(d) The SOPs that comply with paragraph (G) of this rule for each analyte, parameter group, and corresponding method for which the laboratory applies for certification, including, but not limited to, as appropriate, the following:
(i) SOPs for preparation and analysis of samples.
(ii) The interpretation of data, such as manual integration of instrument chromatographs.
(iii) SOPs for cleaning of canisters designed to collect air samples.
(e) The laboratory's method detection limit study for each analyte and parameter group, and corresponding method, except for the analytes or parameter groups provided under paragraph (B)(1) of this rule. The method detection limit study shall include use of spiked solutions and method blanks. The spiked solutions final spiking concentrations shall not exceed the laboratory's reporting limit. The following information shall be provided for each analyte and parameter group in spreadsheet format:
(i) Spiking concentration for each analyte or parameter group including units.
(ii) Method numbers for which the laboratory applies for certification.
(iii) Extraction, digestion, distillation, preparatory, and analysis dates or date range. The laboratory shall digest, extract, or distill all method detection limit study samples using the procedures included in the SOPs submitted under paragraph (D)(1)(d) of this rule.
(iv) Individual results of the method detection limit study samples.
(v) The calculated standard deviation, calculated method detection limit, and reporting limit for each analyte or parameter group.
(vi) For method detection limits calculated from quarterly method detection limit verification samples, information for the ongoing method detection limit verifications and documentation for the recalculations associated with the ongoing verifications, as appropriate.
(f) For a fixed-base laboratory that applies for initial certification, payment of the non-refundable certification fee required by rule 3745-300-03 of the Administrative Code.
(g) For a mobile laboratory that applies for initial certification or a certified laboratory that applies for additional certification, the actual costs incurred by Ohio EPA as required by rule 3745-300-03 of the Administrative Code.
(h) The information listed in paragraph (D)(3) of this rule, if the laboratory applies for certification for asbestos, or paragraph (D)(4) of this rule, if the laboratory applies for certification for a performance-based method, as provided in paragraph (B) of this rule.
(i) The information listed in paragraph (D)(5) of this rule, if the laboratory applies for certification for the analysis of any constituent other than asbestos that relies on maintaining accreditation in good standing from a NELAP accreditation body recognized by TNI.
(j) For additional certification requests, Ohio EPA may waive some requirements in paragraph (D)(1) of this rule, depending on the analyte, parameter group, or method the laboratory intends to add, and the current certification held by the laboratory.
(2) Applications for renewal certification. A certified laboratory shall submit to Ohio EPA a complete application, in the format prescribed by Ohio EPA, prior to the expiration date listed on the laboratory's current certificate. If Ohio EPA receives a renewal application less than ninety days prior to the expiration date on the laboratory's current certificate, the result may be a lapse in certification. A certified laboratory that requests certification changes shall comply with paragraph (Q) of this rule. To apply for renewal certification, a laboratory shall submit to Ohio EPA the following:
(a) The original completed application for renewal certification, including the affidavit, signed by a person authorized to submit the affidavit on behalf of the laboratory, affirming, based upon knowledge, information, and belief, that all information provided in the application and associated documentation is true, accurate, and complete. The application shall be on the form provided by Ohio EPA.
(b) The payment of the non-refundable annual fee required by rule 3745-300-03 of the Administrative Code.
(c) Notification of any analyte, parameter group, or method the laboratory intends to drop from the laboratory's certification.
(d) Notification of any analyte, parameter group, or method the laboratory intends to add to the laboratory's certification. The addition of an analyte, parameter group, or method also requires completion of the application for initial or additional certification as required by paragraph (D)(1) of this rule.
(e) If the laboratory intends for the laboratory's renewal certification to be based on maintaining third-party accreditation in good standing in accordance with paragraph (A)(4) of this rule, the laboratory shall provide the documentation required by paragraphs (D)(3) and (D)(5) of this rule.
(3) Asbestos certification.
(a) A laboratory that applies for initial or additional certification for the analysis of asbestos under paragraph (B)(1)(d) of this rule shall submit a photocopy of a current certificate or other form of documentation issued by an accreditation program listed in paragraph (B)(1)(d) of this rule. The submittal shall include the documentation required by paragraph (D)(1) of this rule, excluding paragraphs (D)(1)(c) and (D)(1)(e) of this rule.
(b) A certified laboratory that applies for renewal of the laboratory's asbestos certification shall submit a photocopy of a current certificate or other form of documentation issued by an asbestos accreditation program that documents that the accreditation remains in good standing.
(4) Performance-based method certifications. A laboratory that applies for initial or additional certification for any performance-based method as provided in paragraph (B)(1)(c) of this rule shall submit the documents listed in paragraph (D)(1) of this rule, and shall submit the following:
(a) Laboratory check sample data. At a minimum, seven data points for each analyte or parameter group and matrix.
(b) Quality control limits derived from the data points collected pursuant to paragraph (D)(4)(a) of this rule.
(c) In addition to compliance with the minimum requirements of paragraph (G) of this rule, any additional minimum requirements that are included in the SOPs used to analyze analytes or parameter groups in order to ensure the laboratory's ability to provide reliable, defensible, and representative data.
(d) Any other information Ohio EPA deems appropriate.
(5) Applications that rely on NELAP accreditation.
(a) A laboratory that applies for initial or additional certification for analysis of any constituent other than asbestos that relies on maintaining accreditation in good standing from a NELAP accreditation body recognized by TNI shall submit the following:
(i) A copy of the current certificate, or other form of documentation issued by the NELAP accreditation body, that documents that the accreditation remains in good standing.
(ii) Documentation from the NELAP accreditation body that supports the analytes, parameter groups, and methods for which the laboratory seeks certification.
(iii) Documentation required by paragraph (D)(1) of this rule, except that information required by paragraphs (D)(1)(c) and (D)(1)(e) of this rule, may be excluded, unless otherwise requested by Ohio EPA.
(b) A laboratory that applies for renewal certification for analysis of any constituent other than asbestos that relies on maintaining accreditation in good standing from a NELAP accreditation body recognized by TNI shall submit the following:
(i) A copy of the current certificate, or other form of documentation issued by the NELAP accreditation body, that documents that the accreditation remains in good standing.
(ii) Documentation from the NELAP accreditation body that supports the analytes, parameter groups, and methods for which the laboratory seeks renewal certification.
(iii) Documentation required by paragraph (D)(2) of this rule.
(E) Procedures used to evaluate laboratory applications for initial or additional certification are the following:
(1) Ohio EPA's review of a laboratory's application for certification begins within thirty days after receipt of a complete application. An application that contains all of the information required by paragraph (D) of this rule is considered complete. Ohio EPA's review includes, but is not limited to, the following:
(a) Review of the laboratory's application to ensure that all necessary components are included.
(b) For applications that rely on third-party accreditation bodies, review of the documentation required by paragraphs (D)(3) and (D)(5) of this rule that demonstrate that the accreditation is in good standing.
(c) A detailed review of the information required by paragraph (D) of this rule, such as a laboratory's SOPs, QAPP, method detection limit studies, proficiency testing results, or any other required information, as applicable.
(d) If applicable, a laboratory audit of the laboratory that applies for initial certification. Ohio EPA may conduct a laboratory audit of a certified laboratory that applies for additional certification. Laboratory audits are conducted in accordance with paragraph (J) of this rule.
(e) If applicable, review the laboratory's response to correct deficiencies that were identified during a laboratory audit conducted in accordance with paragraph (J) of this rule.
(f) A determination that the laboratory paid the fee and actual costs incurred by Ohio EPA as established in rule 3745-300-03 of the Administrative Code.
(2) Ohio EPA may request additional information that Ohio EPA deems relevant for consideration of the request for certification, even after Ohio EPA determines the application for certification is complete. The applicant shall provide the requested information in a timely manner. Failure to respond to Ohio EPA's request for additional information may be grounds for denial of the application.
(3) To receive certification, a laboratory shall demonstrate to the director's satisfaction that the laboratory complies with this rule. The laboratory shall possess the ability to provide reliable, defensible, and representative data that complies with the requirements for certified data under this rule.
(4) Unless the request for certification is withdrawn by the applicant, the director shall either approve or deny certification:
(a) If approved, the certification is valid for three years after the date of approval, unless the certification is suspended or revoked.
(b) If the director denies certification, the director shall provide to the applicant a letter that describes the deficiencies upon which the certification denial is based.
(F) Procedures used to evaluate certified laboratory applications for renewal certification are the following:
(1) A certified laboratory may renew the laboratory's certification under this rule for only the analytes, parameter groups, and methods for which the laboratory is currently certified, except as provided in paragraph (F)(2)(f) of this rule.
(2) As provided in paragraph (D)(2) of this rule, a certified laboratory shall submit a complete renewal application prior to the expiration date listed on the laboratory's current certificate. If Ohio EPA receives a renewal application less than ninety days prior to the expiration date on the laboratory's current certificate, the result may be a lapse in certification. Ohio EPA's review of the application for renewal certification begins thirty days after receipt of a complete application. An application that contains all of the information required by paragraph (D) of this rule is considered complete. Ohio EPA's review includes, but is not limited to, the following:
(a) Review of the laboratory's application to ensure that the laboratory is certified for the analytes, parameter groups, and methods listed on the application.
(b) For certifications that rely on third-party accreditation bodies, review of the documentation required by paragraphs (D)(3) and (D)(5) of this rule that demonstrate that the accreditation remains in good standing.
(c) In accordance with paragraph (J)(5) of this rule, the information required by paragraph (F)(2)(b) of this rule shall be provided in the laboratory's renewal application.
(d) Review of the laboratory's response to correct deficiencies that were identified during a laboratory audit conducted in accordance with paragraph (J) of this rule.
(e) A determination that the laboratory paid the annual fee and actual costs incurred by Ohio EPA for laboratory audits, as established in rule 3745-300-03 of the Administrative Code.
(f) Review any request for additional analytes, parameter groups, or methods the laboratory intends to add to the laboratory's certification, in accordance with paragraphs (D) and (E) of this rule.
(g) Ohio EPA may approve renewal of a laboratory's certification without the inclusion of the requested additional analytes, parameter groups, or methods. Ohio EPA's review of the requested additional analytes, parameter groups, or methods shall continue and can be added to the certification at a later date if approved by the director.
(3) Ohio EPA may request additional information that Ohio EPA deems relevant for consideration of the request for renewal certification, even after Ohio EPA determines the application is complete.
(4) The director may deny a laboratory's application for renewal certification if the director determines that the laboratory failed to comply with any of the requirements of this rule.
(5) Renewal of a laboratory's certification past the expiration date on the certificate shall be addressed as follows:
(a) The director may choose to delay renewal of a laboratory's certification past the expiration date on the certificate if deficiencies that were identified during a laboratory audit remain unresolved. Renewal of a laboratory's certification may be approved after the expiration date and after resolution of any outstanding deficiencies.
(b) The director may choose to delay renewal of a laboratory's certification past the expiration date on the certificate if the renewal application is submitted less than ninety days prior to the expiration date on the certificate and Ohio EPA did not have adequate time to process the renewal application.
(c) If renewal of a laboratory's certification is delayed past the expiration date on the certificate for reasons identified in paragraph (F)(5)(a) or (F)(5)(b) of this rule, the laboratory is not required to submit an initial application to obtain certification renewal unless the director ultimately denies the request for renewal.
(G) Minimum requirements for the QAPP and SOPs. Each certified laboratory shall have a written QAPP and written SOPs for every method and procedure used by the laboratory to produce certified data, and shall keep these documents at the laboratory for use by laboratory personnel. The QAPP and SOPs shall comply with paragraph (A)(2)(c)(iii) of this rule and the methods published or endorsed by U.S. EPA, except as specified in this rule.
(1) At a minimum, the QAPP shall include provisions that require laboratory reports issued in compliance with this chapter to contain the following:
(a) An accompanying affidavit that complies with paragraph (P) of rule 3745-300-13 of the Administrative Code.
(b) At a minimum, a case narrative that includes the following:
(i) Discussion of any issues that impact the quality of the data with sample receipt, sample process, or sample analysis.
(ii) Discussion of any potential bias in sample results, as appropriate.
(c) A report of the analytical results determined by the methods indicated on the laboratory's certificate.
(d) A report of the quality control sample results and indication of whether applicable criteria were met.
(e) A copy of the chain of custody that accompanied the samples to the laboratory.
(f) At a minimum, a copy of the sample receipt form that records the following:
(i) Temperature of samples upon receipt by the laboratory, if the method requires monitoring.
(ii) Date and time the samples were received by the laboratory.
(iii) Notation of whether holding times specified in the SOPs for sampling preparation and analysis were exceeded.
(iv) Any exceptions or special instructions for sample handling, analysis, or reporting.
(v) Notation of whether samples include appropriate labeling, such as the date and time of sample collection and a sample identification notation.
(vi) Notation of whether sample containers contain appropriate sample preservatives, if applicable.
(vii) Description of the general condition of sample containers, including whether any containers were damaged or improperly filled.
(2) Data interpretation and reporting requirements. To ensure quality data interpretation and quality reporting of laboratory results, the QAPP or SOPs shall include, at a minimum, the following:
(a) SOPs shall include information regarding how the qualitative and quantitative analyses are performed and interpreted by the analysts.
(b) Laboratories shall report solid samples on a dry weight basis, unless otherwise dictated by the method or when inadequate sample volume limits the laboratory's ability to determine dry weight. The moisture content also shall be reported, when applicable. SOPs shall include processes and calculations for this purpose.
(c) Prior to issuance of the laboratory reports as certified data, laboratories shall complete peer review of applicable calibration, calibration verification, quality assurance, and quality control results, as well as sample laboratory results.
(d) SOPs for methods that include manual integration of chromatographic data to ensure that manual integrations are performed in a consistent and technically justifiable manner for standards, samples, and quality control solutions. The SOPs shall contain the following minimum requirements:
(i) Examples of proper and improper manual integrations.
(ii) Procedures to manually adjust data to ensure that obvious inaccuracies in automated integrations are corrected and that reported results accurately reflect the information contained in the analytical data.
(iii) Both original and modified chromatograms, including the chromatographic peaks and baselines, shall be peer reviewed.
(iv) The laboratory shall retain copies of the original and modified chromatograms. These shall be made available to Ohio EPA, or other interested parties, upon request.
(e) As appropriate, the QAPP or SOPs shall contain a provision that the laboratory shall narrate potential bias in sample results if the requirements in the SOP cannot be met, including, but not limited to, the following:
(i) Failure to meet required holding times.
(ii) Improper sample preservation.
(iii) Inability to perform corrective actions for calibration, calibration verification, or quality control outliers.
(iv) Insufficient sample amount.
(f) For dual column analysis, the following apply:
(i) Results shall only be reported if the analyte is detected in both columns.
(ii) If the laboratory does not designate a primary column, then the higher result shall be reported unless a matrix interference is causing the elevated concentration.
(iii) If the laboratory designates a primary column, then the results from the primary column shall be reported unless matrix interference is present.
(iv) In cases where matrix interference is present, the lower result, or both results, shall be included in the analytical report.
(g) Analytes reported as certified data shall meet all calibration, calibration verification, and quality control criteria. If analytes do not meet criteria, then the analytes shall not be reported as certified data except as provided in paragraph (G)(2)(e)(iii) or (G)(4)(c) of this rule. This applies to all analytes including, but not limited to, the following:
(i) Analytes traditionally known as poor performers or common laboratory contaminants.
(ii) Analytes that may meet method criteria through provisions of marginal exceedance.
(h) Laboratories shall not provide certified data for tentatively identified compounds.
(i) As appropriate, the QAPP or SOPs shall require the laboratory to report as certified data only analytes specified in the method, unless the laboratory's certification specifically allows reporting of additional analytes for the method. If a laboratory report includes analytes that are not specified in the method and are not specifically allowed by the laboratory's certification, the laboratory shall identify the analytes as exceptions to the certified data attested to in the affidavit that is issued with the laboratory report.
(j) If a laboratory's certification relies on maintaining third-party accreditation in good standing, the laboratory shall not report certified data under this rule when the relied-upon third-party accreditation is not in good standing with the issuing accreditation body.
(k) Samples for metals analysis that are filtered prior to digestion shall be reported as dissolved metals. Unfiltered samples or samples that are filtered after digestion may be reported as total metals.
(3) Instrument calibration requirements. To ensure the quality of the data to be analyzed, the QAPP or SOPs shall comply with the approved method and shall include the following minimum instrument calibration requirements:
(a) At a minimum, SOPs shall include all of the following calibration requirements:
(i) Information about the frequency of initial calibration and calibration verification.
(ii) Criteria to evaluate results of initial calibration and calibration verification, including calibration blanks.
(iii) Without exception, corrective actions the analyst shall follow for initial calibration, calibration verification, and calibration blanks when these standards do not meet the criteria required by paragraph (G)(3)(a)(ii) of this rule, as applicable.
(iv) A prohibition against forcing the initial calibration curve through the origin.
(v) A prohibition against use of the zero point in an initial calibration curve, unless specified by the method or there are instrument limitations.
(vi) Nonlinear initial calibrations (e.g., quadratic calibration model) may be used but are restricted to compounds that have historically exhibited a nonlinear response.
(vii) Nonlinear initial calibration models shall not be used to extend the calibration range for compounds that normally exhibit a linear response.
(viii) The lowest standard concentration used for initial calibration shall be at or below the laboratory's practical quantitation limit.
(b) Standard operation procedures shall specify initial calibration models as follows:
(i) For quadratic calibration models, a minimum number of standard concentrations is six.
(ii) Unless otherwise specified by the method, for all other calibration models, the minimum number of standard concentrations is five.
(iii) If more than the minimum number of standard concentrations is used, only the lowest or highest standard concentrations may be omitted from the calibration model as long as the minimum number of standard concentrations from paragraph (G)(3)(b)(i) or (G)(3)(b) (ii) of this rule are retained for use.
(c) Calibration solutions shall meet the following minimum requirements:
(i) Unless the method allows for use of a different solution, the same solution used to prepare the initial calibration standards shall be used to prepare the continuing calibration verification standard.
(ii) Unless use of the same solution is specifically allowed by the method, when an initial calibration verification standard is included in a method, a different solution other than the one used to prepare the calibration curve shall be used.
(iii) A prohibition on the use of expired standards or spiking solutions, except for the analysis of air samples.
(iv) For analysis of air samples, expired standards or spiking solutions may be used if revalidated against an unexpired reference material or if recertified by the vendor. The laboratory shall keep on file the documentation of such revalidation or recertification.
(v) Retention time marker solutions shall be used for petroleum analysis. These solutions shall be analyzed before the instrument is calibrated.
(d) For all dual column analysis, the calibration criteria required by paragraphs (G)(3)(a) to (G)(3)(c) of this rule shall be met on the column used to report data as certified.
(4) Quality control. To ensure reliable data, the QAPP or SOPs shall comply with the approved method and shall include the following:
(a) Identify all reagents, standards, and spiking solutions to be used in sample preparation and analysis.
(b) Define criteria for the quality control solutions or provide reference as to where the information is available. When criteria are not met for all associated quality control solutions, including but not limited to the method blank and spiked laboratory control solutions, or when surrogate recoveries or internal standard recoveries fail to meet the defined criteria in samples or quality control solutions, corrective actions shall occur, except as provided in paragraph (G)(2)(e)(iii) or (G)(4)(c) of this rule. Upon re-analysis of the failed quality control solution once, appropriate corrective actions may include re-preparation of the entire batch, including re-digestion, re-distillation, or re-extraction.
(c) When surrogates, internal standards, method blanks, calibration verification solutions, or spiked laboratory control solutions are biased high and the associated samples are non-detect for the outlying analytes, corrective actions need not be taken, and reporting of certified data is acceptable.
(d) Include procedures to prepare initial, continuing, and calibration verification standard solutions and calibration blank solutions.
(e) Include procedures to prepare samples, including the weight or volume of the media.
(f) Calibration verification solutions shall contain all target analytes, except for the analysis of polychlorinated biphenyls. For polychlorinated biphenyl analysis, a spike mix that contains aroclors 1016 and 1260 is sufficient to represent the range of aroclors specified in the method.
(g) SOPs shall include information regarding quality control solutions, including all of the following:
(i) Frequency of analysis.
(ii) Weight or volume of the media used.
(iii) Criteria used to evaluate results.
(h) Quality control solutions shall be treated in the same manner as samples, including handling, preservation, preparation, and equipment use.
(i) All detections in the method blank equal to or greater than the reporting limit require corrective actions as specified in paragraph (G)(4)(b) of this rule.
(j) All calibration verification standards required by the method and evaluated for per cent recovery, as defined by the methods, shall be reported based on the true value of the standard.
(k) To report dual column analysis data as certified, criteria required by paragraph (G)(4)(b) of this rule for quality control solutions shall be met on the column used.
(5) Preparation of samples. To ensure the quality of the samples to be analyzed, the QAPP or SOPs shall comply with the approved method and shall include the following minimum requirements for preparation of samples:
(a) Identify requirements for sample preservation, storage, holding times (including beginning and ending times), and the proper sample collection container, including the following:
(i) If requirements from the approved method do not specify requirements for sample preservation, storage, holding times, and the proper sample collection container, the laboratory shall include such requirements in the QAPP or SOPs, as applicable.
(ii) Holding times described in the approved method shall not be increased by alternate preservation techniques or by alternate demonstrations.
(iii) Air samples from "Tedlar" bags shall not be reported as certified data. The transfer of air samples from "Tedlar" bags to a canister for air analysis shall be prohibited.
(b) Identify equipment used for sample preparation, and identify diluents used for all dilutions.
(c) Identify requirements to be followed for holding times for extracted, digested, or distilled samples, and the storage requirements and the proper storage containers for each.
(d) Include details to ensure that sample preparation specifications for digestion, distillation, clean-up, and extraction shall meet the final volume for analysis, either volumetrically measured or otherwise verified to meet volumetric specifications.
(e) If the preparatory batch standards (i.e., initial calibration or calibration verification standards) for digestion, distillation, or extraction are processed with the sample and the batch standards fail either quality control criteria or calibration criteria, upon re-analysis of the failed quality control solutions or calibration solutions once, the entire batch shall be prepared again. The corrective action shall occur except as provided in paragraph (G)(2)(e)(iii) or (G)(4)(c) of this rule.
(f) Analysis of non-aqueous samples for volatile organic compounds shall utilize a closed-system purge-and-trap process consistent with "SW-846" method 5035 or method 5035A, unless the analytical method pre-dates December 1996.
(g) For organic extraction methods that include instruction for drying solid matrix samples, surrogates or any other spiking compounds shall be added with the drying agent and into the homogenous mixture of sample or quality control sample. Surrogates or any other spiking compounds may not be added via the extraction solvent to samples and the associated quality control solutions.
(6) Analysis of samples. To ensure the quality of the samples to be analyzed, the QAPP or SOPs shall comply with the approved method and shall include the following minimum requirements:
(a) Identify equipment and instrumentation used for analysis of samples.
(b) For organic analysis methods, samples with failing internal standard or surrogate criteria require re-analysis of the samples. Dilutions shall be made only if matrix interference is present. Dilutions shall not be made for the sole purpose to meet, or attempt to meet, internal standard or surrogate criteria.
(c) When mass spectrometry methods are used, designate the primary and secondary ions used for identification of compounds.
(d) Laboratories that report selective ion monitoring data shall include operating procedures for selective ion monitoring analysis within the associated SOP.
(7) At a minimum, the written QAPP shall meet any necessary requirements in paragraphs (G)(1) to (G)(6) of this rule and shall include provisions that describe the following:
(a) Procedures that require proper citation and use of method numbers, including the appropriate revision suffix, if applicable, shall be consistently identified and included on instrument printouts, log books, analytical reports, and any other laboratory documents. All method numbers plus the revision suffix, if applicable, shall correlate with the method number and revision suffix on the certificate issued under this rule.
(b) SOPs requirements shall be reviewed for potential updates at least once every two years.
(c) Describe storage requirements of samples during all phases of analysis.
(d) Provide details for the expiration of stock standards, solutions, and all working standards and solutions, or cross-reference to the location of that information.
(e) Identify how the laboratory shall establish quality control acceptance limits for the analysis of samples.
(f) Identify how the laboratory shall manage waste in accordance with all applicable federal, state, and local requirements.
(g) Include a provision to address initial and periodic training for personnel in sample receipt, preparation, analysis, and data interpretation and review:
(i) Laboratory personnel shall review the QAPP and applicable SOPs which relate to the tasks associated with laboratory personnel's duties at the laboratory. Laboratory personnel shall sign documentation that acknowledges review of the documents.
(ii) The laboratory shall maintain training records and documentation that the laboratory personnel reviewed the appropriate documents.
(H) Standards of performance and conduct to maintain certification. To maintain certification under this rule, a certified laboratory shall do the following:
(1) Produce results as certified data pursuant to paragraph (A) of this rule when the laboratory is requested to provide data in support of a voluntary action under this chapter or Chapter 3746. of the Revised Code.
(2) Disclose when the laboratory does not hold certification for a requested analyte, parameter group, or method included in a request for analysis. After this disclosure, if the requester still requests the analysis to be performed, the laboratory shall specify in the affidavit that accompanies the analytical report the analytes, parameter groups, or methods for which the laboratory is not providing certified data.
(3) Comply with the methods for which the laboratory is certified.
(4) Notify Ohio EPA in writing within thirty days after any of the following:
(a) A change in management personnel or quality assurance personnel.
(b) A change in laboratory operations that affects the laboratory's ability to perform analyses pursuant to this rule.
(c) A change in name or ownership of the laboratory.
(d) A relocation of the laboratory, in whole or in part, or a change of address of the laboratory.
(e) Anything that results in the loss of accreditation, temporarily or permanently, that is relied upon for certification under paragraph (A)(4) of this rule for any analytes, parameter groups, or methods for which the laboratory holds certification.
(5) Perform acceptably on each laboratory audit conducted pursuant to this rule, and address in a timely manner the deficiencies that are identified by Ohio EPA.
(6) Perform analyses in accordance with the laboratory's QAPP and SOPs that are consistent with paragraph (G) of this rule when the laboratory produces certified data.
(7) Disclose when the laboratory cannot quantify at or below an applicable standard specified in a request for analysis as follows:
(a) The certified laboratory shall provide certified data that detects chemicals of concern in environmental media at or below the applicable standards, unless the laboratory discloses that the laboratory is incapable of achieving an applicable standard under the laboratory's certification.
(b) Unless the certified laboratory is otherwise informed of the need for a lower applicable standard, the certified laboratory shall quantify at or below the single chemical generic numerical standards in appendices A and B to rule 3745-300-08 of the Administrative Code.
(c) If a certified laboratory that performs analyses in support of a no further action letter but is not capable of detecting the chemicals of concern in environmental media at or below the applicable standards, the certified laboratory shall notify, in writing, the person who requests the analysis that the laboratory cannot quantify at or below an applicable standard using a method for which the laboratory is currently certified. The laboratory may disclose this information in the analytical report or by other means.
(8) Not falsify any information on any application, SOP, QAPP, or any proficiency testing result, or any certified data used in support of a no further action letter, or any other submittal to Ohio EPA.
(9) Not perform analyses in support of a request for a no further action letter for which the laboratory has a conflict of interest.
(10) Provide Ohio EPA access to the laboratory's facility and documents, data, or information related to any voluntary action, or laboratory certification, in order to determine compliance with this chapter and Chapter 3746. of the Revised Code.
(11) Promptly and completely respond to all document and data requests made by the director under this chapter and Chapter 3746. of the Revised Code.
(12) Pay all costs and fees required by rule 3745-300-03 of the Administrative Code.
(13) As required by this rule and rule 3745-300-13 of the Administrative Code, submit by affidavit all information, data, documents, and reports for use in support of a request for a no further action letter.
(14) Conduct laboratory operations in compliance with all applicable federal and state laws, regulations and rules, including but not limited to, requirements for management and disposal of samples that meet the definition of "hazardous waste" in rule 3745-51-03 of the Administrative Code and other hazardous wastes stored on property in compliance with Chapters 3745-52 and 3745-65 of the Administrative Code.
(15) Maintain in good standing any third-party accreditations relied upon for certification.
(I) Procedures for submittals under this rule are the following:
(1) All applications and documentation provided to Ohio EPA in accordance with this rule shall be submitted to Ohio EPA in a format prescribed by Ohio EPA.
(2) Payment of fees or costs incurred by Ohio EPA under this rule shall be paid in accordance with paragraph (G) of rule 3745-300-03 of the Administrative Code.
(J) Laboratory audits.
(1) At Ohio EPA's discretion, Ohio EPA shall audit laboratories to determine compliance with this rule or to evaluate a laboratory's qualifications to become certified under this rule. Laboratory audits may consist of a review of either documents or other information submitted to Ohio EPA. Laboratory audits may include an on-site visit to the laboratory to review the laboratory's operations and to evaluate the laboratory's facility and personnel.
(a) During a laboratory audit, Ohio EPA shall evaluate a laboratory's qualifications to become certified to perform analyses in accordance with this rule, at either of the following occurrences:
(i) When a laboratory applies for initial certification.
(ii) During review of a certified laboratory's application for additional certification, renewal certification, or if the laboratory relocates the laboratory facility.
(b) At any time and for any purpose, Ohio EPA shall evaluate a certified laboratory to determine a laboratory's compliance with the laboratory's obligations as a certified laboratory under this rule and the laboratory's ability to produce certified data in accordance with this rule. Ohio EPA may conduct this evaluation for any reason, including but not limited to, the following:
(i) When there is a change in laboratory personnel, management personnel, operational procedures, or other functional issue.
(ii) To evaluate a laboratory prior to the renewal of the laboratory's certification.
(iii) If Ohio EPA receives a complaint regarding the laboratory's performance.
(c) Ohio EPA may conduct audits of mobile laboratories while the laboratory is either mobilized on a project or at the laboratory's headquarters. Ohio EPA may conduct an audit of the location where the data undergoes quality assurance review, if the quality assurance review is not performed in the mobile laboratory.
(2) In order to determine compliance with this rule, an audit of a laboratory may include, but is not limited to, the following:
(a) Review of the laboratory's SOPs, QAPP, analytical reports and associated data, affidavits, and other documents.
(b) On-site visit and review of the laboratory's sample receiving area, waste storage area, analytical testing areas, and other pertinent areas of the laboratory. During the visit, Ohio EPA may review the following:
(i) Log books.
(ii) Sample storage procedures.
(iii) Instrumentation set-up and software programs.
(iv) Equipment calibration and maintenance procedures.
(v) Data review procedures.
(vi) Record filing and storage.
(vii) Project management and communication procedures.
(viii) Data reporting procedures.
(ix) Record files.
(x) Any other information or area of the laboratory deemed appropriate by Ohio EPA.
(c) Interviews of laboratory personnel to determine knowledge of personnel who perform the analyses.
(d) Review of any other documentation that Ohio EPA considers appropriate, including, if applicable, review of any documents related to third-party accreditation relied upon for certification.
(e) Review of performance testing results, as required by paragraph (C) of this rule.
(f) Evaluation of whether any violations of this rule are material in a laboratory's ability to report reliable, defensible, and representative data that satisfies the requirements for certified data under this rule.
(3) Ohio EPA shall prepare an audit report that indicates any deficiencies that are identified during the audit that require corrective actions by the laboratory. Failure to address the deficiencies in a timely manner may result in suspension or revocation of a laboratory's certification, denial of a request for initial or additional certification, or denial of a laboratory's request to renewal the laboratory's certification.
(4) If Ohio EPA identifies any deficiencies during a laboratory audit, the laboratory shall correct those deficiencies to Ohio EPA's satisfaction before receipt of an initial, additional, or renewal certification.
(5) If the current certification was not previously based on third-party accreditation and the laboratory elects to provide documentation of third-party accreditation during a laboratory audit, the laboratory shall include in the laboratory's renewal application documentation that demonstrates that the accreditation remains in good standing for the purpose of the laboratory's renewal certification.
(6) Pursuant to rule 3745-300-03 of the Administrative Code, Ohio EPA shall recover Ohio EPA's actual costs to conduct audits.
(K) Laboratory certifications:
(1) After completion of the requirements in this rule, the director shall provide to the laboratory a certificate that identifies the analytes, parameter groups, or methods for which the laboratory may perform analyses. The certification, issued by the director, may limit the analysis of certain environmental media.
(2) The certification automatically expires three years after the date of issuance, unless the laboratory's certification is suspended, revoked, or renewed prior to the certification's expiration.
(3) The certification expiration date for additional certification is the same as that of the laboratory's initial certification or renewal certification, as applicable.
(4) The certification applies only to the individual laboratory facility identified in the certificate. Entities that own or operate multiple laboratories shall apply for a separate certification for each laboratory facility.
(5) If a laboratory changes location, the laboratory shall reapply for certification as an initial application to continue the laboratory's certification.
(6) The effective certificate shall be displayed in a prominent location in the laboratory.
(7) If a laboratory's certification is revised, the revised certification supersedes any prior certification.
(L) Retention of documents and data.
(1) A laboratory shall maintain all documents and data prepared or acquired in connection with a voluntary action for a period of at least ten years after the date that the laboratory's analyses were submitted to a certified professional or volunteer.
(2) The laboratory may retain the documents and data using any available technology, provided that the laboratory can readily retrieve the documents and data in legible condition when retrieval is requested by Ohio EPA during the ten-year retention period.
(3) If a laboratory does not intend to retain such documents and data after ten years, the laboratory shall notify Ohio EPA of such intent, and shall provide Ohio EPA the opportunity to obtain the documents and data.
(4) The documents and data shall be retained until the notice described in paragraph (L)(3) of this rule is provided to Ohio EPA, and Ohio EPA notifies the laboratory in writing whether Ohio EPA shall obtain the documents and data.
(5) Notification of Ohio EPA pursuant to this paragraph is not required as long as a laboratory continues to retain all documents and data.
(6) Failure to provide documents or data requested by Ohio EPA may result in permanent revocation of the laboratory's certification in accordance with paragraph (O)(3) of this rule.
(M) Out-of-state laboratories.
(1) As a condition of certification under this rule, laboratories, or companies that own mobile laboratories, located outside the state of Ohio consent to service of process and to personal jurisdiction of any Ohio court or the Ohio environmental review appeals commission in proceedings that adjudicate any rights or obligations under this chapter and Chapter 3746. of the Revised Code, or in which the cause of action involves, in whole or in part, the laboratory's performance under this chapter or Chapter 3746. of the Revised Code.
(2) Out-of-state laboratories consent to Ohio EPA's right of entry for inspection or investigation, and to the service of administrative warrants, inspection warrants, or other appropriate search warrants as a condition of certification under this rule.
(N) Appeal of certification determinations. The issuance, denial, suspension, or revocation of any laboratory certification is a final action of the director, which is subject to the procedure for appeal provided in Chapter 3745. of the Revised Code.
(O) Revocation or suspension of certification.
(1) The director may revoke or suspend a laboratory's certification issued pursuant to this rule, for a period to be determined by the director, upon finding that a laboratory failed to comply with paragraph (H) of this rule, except as provided in paragraphs (O)(2) and (O)(3) of this rule.
(2) The director may permanently revoke a laboratory's certification if the laboratory falsifies any information in connection with the laboratory's certification or any voluntary action, in violation of paragraph (H)(8) of this rule.
(3) The director shall permanently revoke a laboratory's certification if the laboratory does not comply with a request for documents and data, in violation of paragraph (H)(11) of this rule.
(4) If a laboratory's certification relies upon maintaining third-party accreditation in good standing, the director may revoke or suspend a laboratory's certification upon finding that the laboratory's third-party accreditation is no longer maintained in good standing.
(5) Upon revocation or suspension of certification, the laboratory shall promptly return to Ohio EPA the certificate to which the revocation or suspension applies.
(P) Procedure to request reinstatement of certification.
(1) Procedures to request reinstatement of certification after a suspension period are as follows:
(a) A suspended laboratory may request to reinstate the laboratory's certification for a suspension issued because of the laboratory's failure to comply with paragraphs (H)(1) to (H)(7), (H)(9) to (H)(10), and (H)(12) to (H)(14) of this rule.
(b) After the suspension period, the laboratory may request reinstatement of the laboratory's certification by providing the following:
(i) A written request for reinstatement and any documentation to demonstrate that the laboratory resolved all findings which resulted in the suspension.
(ii) Information consistent with requirements for a renewal certification as required by paragraph (D) of this rule. Ohio EPA's evaluation of the information submitted shall be consistent with paragraph (F) of this rule.
(2) Pursuant to rule 3745-300-03 of the Administrative Code, the laboratory is required to pay any costs incurred by Ohio EPA to review requests for reinstatement.
(3) During a laboratory's suspension period, a laboratory may request adjustments to the laboratory's suspended certification so that the laboratory's reinstated certification reflects new analytes, parameter groups, or methods after completion of the laboratory's suspension period. Adjustments are subject to paragraphs (D), (E), (F), and (Q) of this rule.
(4) If Ohio EPA conducts a laboratory audit of the laboratory as a result of paragraph (P)(3) of this rule, the laboratory shall do one of the following:
(a) Perform acceptably on the audit.
(b) Prior to reinstatement of the laboratory's certification, shall correct any deficiencies that are identified during the audit. Laboratory audits shall be conducted consistent with paragraph (J) of this rule.
(5) If a laboratory's certification renewal date occurs during a laboratory's suspension period, the laboratory need not submit a request for renewal in accordance with paragraph (D) of this rule. Instead, the laboratory shall comply with this paragraph for reinstatement of the laboratory's certification.
(6) A reinstated certification shall expire one year from the date of the conclusion of the suspension period. The laboratory may renew the laboratory's certification in compliance with paragraph (D) of this rule.
(Q) Procedures to request modifications to certifications.
(1) A laboratory shall request a modification to the laboratory's certificate to reflect changes in company name or address, or to update or remove methods from a certificate. Such a request shall be made on the laboratory's renewal application, or through use of a cover letter when making a request for a modification during a non-renewal period.
(2) In accordance with rule 3745-300-03 of the Administrative Code, the laboratory is required to pay any costs incurred by Ohio EPA to review a request for modification of the laboratory's certification.
(R) Recertification following expiration or revocation of certification.
(1) A laboratory that seeks recertification after a certification expires or was revoked shall comply with the requirements for initial certification provided in paragraphs (D) and (E) of this rule.
(2) Ohio EPA may waive any portion of these requirements, and may require an alternate recertification process.