62-160.330. Approval of Alternative and Modified Laboratory Methods  


Effective on Monday, April 16, 2018
  • 1(1) 2Any person may apply for use of a laboratory method 12in place of the approved methods 18described in subsection 2162-160.320(1), 22F.A.C. 23Any laboratory method proposed for use in place of those described in subsection 3662-160.320(1), 37F.A.C., or in place of laboratory methods specified or required in other rules of the Department must be approved by the Department prior to use, as further required below. 66Laboratory methods that have been previously approved for use in a 77Department rule, 79contract, order, or permit 83shall remain approved while such documents remain in effect. In such cases, the documentation that approved the use of the method must be retained for at least five years after the last use of the method for the specific samples analyzed by the approved method. Laboratory methods 130approved by the Department to meet established data quality objectives according to subsection 14362-160.320(1), 144F.A.C., and alternative or modified laboratory methods previously approved by the Department shall remain approved, except as provided in subsection 16462-160.330(9), 165F.A.C.

    166(2) 167Laboratory methods used in place of those specified or required in Department rules, contracts (including purchase requisitions), orders, or permits are designated by the Department as alternative laboratory methods. 196Alternative laboratory methods that support a Department rule, contract, order, or permit must be approved by the Department prior to use. 217Alternative laboratory methods cannot be approved for the following:

    226(a) Any method that the United States Environmental Protection Agency has designated for analysis of a “method-defined analyte;”

    245(b) The following methods from DEP-SOP-002/01 (January 2017), 253which is incorporated by reference in subparagraph 26062-160.800(1)(b)3., 261F.A.C., including all subparts of the methods cited269:

    2701. Part LT 7300 274of LT 7000, 277Lake Condition Index (LCI) Determination; and,

    2832. Part LT 7600 of LT 7000, 290Determination of Wetland Condition Indices; and,

    296(c) The 298laboratory methods described in the DEP SOPs BRN 1000 (January 2017), SCI 1000 (January 2017), and LVI 1000 (January 2017), including all applicable parts and subparts of the methods cited, which are contained in DEP-SOP-003/11, 333which is 335incorporated by reference in paragraph 34062-160.800(1)(c), 341F.A.C.

    342(3) 343The Department defines a laboratory method modification as any change 353to a published analytical laboratory method that 360alters the scope and applicability, specifications, procedures, steps, performance criteria, or any other requirements described in the published method, as applicable to the analytes and matrices for which the method was originally published. A published method is any 398analytical laboratory 400method specified, recognized or approved by the Department according to subsection 41162-160.320(1), 412F.A.C., or other procedures in scientific 418journals or other technical 422literature.

    423(a) A modified method must satisfy the data quality objectives established by the Department project, permit, rule, contract, order, or data use for which the modifed method will be 452performed; and the laboratory shall retain all data that demonstrate that the modification meets the Department’s data quality objectives471. Additionally, validation of the modified method shall demonstrate that the modified method produces equivalent or superior analytical performance, as compared to the unmodified method, when applicable to the analyte and matrix for which the modifed method will be used. 511These demonstration records shall be retained for at least five years after the last use of the modification for the specific laboratory sample(s) analyzed by the modified method. The Department’s approval of the modified method shall be limited to the specific method scope and modifications validated by the laboratory.

    560(b) 561Upon review of any request to use a modified method, the Department shall determine whether the proposed modified method 580constitutes an 582alternative method according to subsection 58762-160.330(2), 588F.A.C. All proposals to use modified methods as alternative methods shall include the submittal of method validation documentation to the Department 609according to the requirements in subsection 61562-160.330(4), 616F.A.C617.

    618(c) Methods listed in paragraphs 62362-160.330(2)(a) 62462562-160.330(2)(c), 626F.A.C., shall not be modified.

    631(d) When m634ethod modifications 636are specifically allowed 639as indicated in subparagraphs 64362-160.330(3)(d)1. 64464562-160.330(3)(d)3., 646F.A.C., below, 648submittal of method validation documentation to 654the Department prior to use 659is not required, and such modifications are pre-approved by the Department. When laboratory certification is required according to Rule 67862-160.300, 679F.A.C., applicable requirements for method validation, and applicable initial and ongoing demonstrations of capability for use of the modified method shall be performed as required in the applicable testing module of the 2016 TNI Standard, 714which is incorporated by reference in paragraph 72162-160.800(3)(b), 722F.A.C723. In addition, all applicable requirements for the use of non-standard methods, such as validation of methods, as discussed in Module 2 of the 2016 TNI Standard, shall be met for the use of any modified methods requiring laboratory certification.

    7631. Modifications specifically allowed according to descriptions or discussions in the original, unmodified method are pre-approved by the Department. Any constraints or limits to modifications specified in the original method and any required performance criteria for allowed modifications specified in the method shall apply to all pre-approved modifications.

    8112. A813llowable modifications described by the Environmental Protection Agency (EPA) at 82340 CFR, 825Part 136.6, which is incorporated by reference in subsection 83462-160.800(9), 835F.A.C., apply to the 839methods listed at 40 843CFR, Part 136.3, which is incorporated by reference in subsection 85362-160.800(6), 854F.A.C., 855and are pre-approved by the Department. In accordance with 86440 CFR, 866Part 136.6, a facility shall notify the Department’s permit processor of any specific use of a modified method for analysis of compliance samples associated with a permitted facility.

    894a. 895The Department shall consider all interpretations of 90240 CFR Part 136.6 906as published by the EPA on its webpages or in applicable EPA memoranda when responding to requests from any person for assistance in clarifying whether a modification to a method listed at 93840 CFR, 940Part 136.3 is allowed. When such a determination is uncertain or controversial, the Department shall refer the request to the EPA Region 4 Regional Administrator for determination. 967However, this determination shall not supersede any requirements in Department 977rules, contracts, orders, or permits 982to use specific methods.

    986b. Allowable modifications described in 99140 CFR, 993Part 136.6 shall apply to other approved methods that are not listed in 100640 CFR, 1008Part 136.3, which is incorporated by reference in subsection 101762-160.800(6), 1018F.A.C., and shall be considered for pre-approval by the Department upon request. The Department shall consider the applicability of allowable modifications as described in 104240 CFR, 1044Part 136.6, which is incorporated by reference in subsection 105362-160.800(9), 1054F.A.C., to other methods according to sub-subparagraph 106162-160.330(3)(d)2.a., 1062F.A.C., above. If the Department determines that the requested modifications meet Department data quality objectives according to 107940 CFR Part 136.6 1083requirements for the specific use(s) of the method requested and are pre-approved, then the submission of method validation documentation to the Department is not required.

    11083. The Department has determined that methods published by the Environmental Protection Agency (EPA) in the collection titled “1127Test Methods for Evaluating Solid Waste, Physical/Chemical Methods (SW-846)” 1136may be modified to achieve Department data quality objectives 1145when such modifications are 1149made according to the information and requirements for implementing flexibility in the use of SW-846 methods, alternative methods, or modified methods, as discussed in Chapter Two, Section 2.1, in SW-846, which is incorporated by reference in 1185subsection 118662-160.800(11), 1187F.A.C. However, this determination shall not supersede any requirements in Department 1198rules, contracts, orders, or permits 1203to use specific methods.

    1207a. Allowable modifications as discussed in Chapter Two, Section 2.1, in SW-846, shall apply to other approved methods that are not included in the SW-846 collection, and shall be considered for pre-approval by the Department upon request. The Department shall consider the applicability of allowable modifications to other methods according to the information and requirements for implementing flexibility in the use of alternative or modified methods, as discussed in Chapter Two, Section 2.1 of SW-846. If the Department determines that the requested modifications meet Department data quality objectives according to the requirements in Chapter Two, Section 2.1 of SW-846 for the specific use(s) of the method requested and are pre-approved, then the submission of method validation documentation to the Department is not required.

    1330b. The provisions for use of modified methods in sub-subparagraph 134062-160.330(3)(d)3.a., 1341F.A.C., above, shall not supersede requirements in subparagraph 134962-160.330(3)(d)2., 1350F.A.C., above.

    1352(4) 1353Validation documentation shall be submitted to the Department for all proposed alternative methods and for all proposed modified methods not pre-approved by the Department.

    1377(a) V1379alidation information must demonstrate that the alternative or modified method produces equivalent or superior analytical performance in meeting the data quality objectives established for the Department project or specified data use, as compared to the original, unmodified method or to the method for which it is proposed as an alternative.

    1429(b) When validation documentation must be submitted to the Department, 1439alternative 1440laboratory methods and modifications to published laboratory methods 1448shall be demonstrated as appropriate for use according to the requirements in DEP-QA-001/01, 1461which is incorporated by reference in subsection 146862-160.800(5), 1469F.A.C. Alternative and modified methods shall be evaluated according to criteria for demonstrations of initial and ongoing performance as required by the original unmodified method or published alternative method. When laboratory certification is required according to Rule 150662-160.300, 1507F.A.C., applicable requirements for method validation and applicable initial and ongoing demonstrations of capability shall be performed as required in the applicable testing module of the 2016 TNI Standard, 1536which is incorporated by reference in paragraph 154362-160.800(3)(b), 1544F.A.C1545. In addition, all applicable requirements for the use of non-standard methods, such as validation of methods, as discussed in Module 2 of the 2016 TNI Standard, shall be met for the use of any alternative or modified methods requiring laboratory certification.

    1587(5) 1588When evaluating or approving a proposed alternative or modified laboratory method, the Department shall consider the following factors and requirements for review of the proposed method, in addition to those factors and requirements described in DEP-QA-001/01:

    1624(a) Whether procedural steps, use of equipment, use of reagents, use of technology, or other elements of the laboratory method that are proposed are different than those required in the approved laboratory method, as described in 1660subsection 166162-160.320(1), 1662F.A.C;

    1663(b) Whether the use of the alternative or modified laboratory method generates data that meet data quality objectives established by the Department for the data;

    1688(c) Whether the alternative or modified laboratory method is demonstrated to be equivalent to or exceeds the performance of the approved laboratory method that the proposed method or modification is intended to replace;

    1721(d) Whether the Department cannot grant approval of the alternative or modifed method, because use of the proposed method will produce data that are unusable by the Department for a specified purpose, or, if the data will not be comparable to, or are otherwise incompatible for use with existing data generated by other approved laboratory methods, or, if the data would be invalid according to any applicable requirements described in Rule 179262-160.670, 1793F.A.C., below; 1795and,

    1796(e) Whether the laboratory methods were developed by consensus or standardization organizations, such as AOAC International, ASTM International, the United States Environmental Protection Agency, or the United States Geological Survey, or developed by manufacturers or vendors using collaborative interlaboratory studies.

    1836(6) The submitted method validation documentation for an alternative laboratory method or modification of a published method shall be evaluated based on its intended use, and designated as either limited-use or statewide-use, if approved:

    1870(a) For limited-use methods, t1875he Department shall limit the approval of the alternative or modified laboratory method solely for use by the person or organization submitting the request, based on the information and data provided to the Department in support of the request for proposed method approval. 1918A limited-use method is validated by a single laboratory and shall only be used by that laboratory at that location or branch. If the submitter is different than the laboratory that performed the method validation, then the approval for limited use shall only apply to the performing laboratory. Typically, the limited-use method is intended only for testing environmental samples from a particular site, waste stream, facility location, or sample matrix (such as effluent, surface water, groundwater, drinking water, or soil). However, the Department shall approve the proposed limited-use method for any scope that is proposed with the request for approval if the scope of use has been validated by the supporting information submitted with the request, according to all applicable requirements of this rule (Rule 204362-160.330, 2044F.A.C.).

    2045(b) For statewide-use methods, the Department shall evaluate and approve the alternative or modified laboratory method for use by laboratories based on the information and data provided to the Department in support of the request for the alternative or modified method approval. Each application for statewide use will be considered on a case-by-case basis by the Department. Approval for statewide use does not guarantee applicability of the procedure for all potential uses. The Department shall require the design of a collaborative study conducted by multiple independent laboratories to investigate the efficacy and robustness of the proposed statewide-use alternative or modified method for specified site or environmental conditions, sample types, sample matrices, waste streams, analytes, or other specifications applicable to the scope of approval requested, according to the following:

    21731. An inter-laboratory collaborative study following the specifications in Appendix D, Official Methods of Analysis of the AOAC INTERNATIONAL, 19th edition (2012), which is incorporated by reference in subsection 220262-160.800(12), 2203F.A.C., or

    22052. Alternatively, an inter-laboratory collaborative study that is developed and validated based on procedures published by a nationally recognized, consensus-based standards organization (for example, ASTM International).

    22313. Further description and specifications for these studies are provided in DEP-QA-001/01, which is incorporated by reference in subsection 225062-160.800(5), 2251F.A.C.

    2252(7) Research methods shall be submitted for review and approval according to the requirements provided in Rule 226962-160.600, 2270F.A.C. If a method is initially developed for research purposes but will subsequently be used for compliance or other regulatory activities, the method shall be submitted for review and approval according to 2302requirements of Rule 230562-160.330, 2306F.A.C.

    2307(8) The approval or disapproval of any submitted alternative 2316or modified laboratory 2319method shall be noticed as follows:

    2325(a) For 2327limited-use 2328methods, the Department shall issue an order of approval or disapproval of the alternative 2342or modified laboratory 2345method to the person who submitted the method. Any additional administrative or scientific information pertinent to the approval or disapproval of the method shall be included or incorporated by reference in the order. The order and the alternative 2383or modified laboratory 2386method shall also be posted on the Department’s website and 2396provided to 2398all persons enrolled to receive the Department’s Quality of Science electronic newsletter.

    2410(b) For 2412statewide-use 2413methods, the Department shall issue an order 2420of approval or disapproval of the alternative or modified laboratory method 2431to the person who submitted the method. Any additional administrative or scientific information pertinent to the approval or disapproval of the method shall be included or incorporated by reference in the order. A notice of the order approving or disapproving the method shall be published in the Florida Administrative Register. 2481For informational purposes only, 2485the order and the alternative 2490or modified laboratory 2493method shall also be posted on the Department’s website and 2503provided to 2505all persons enrolled to receive the Department’s Quality of Science electronic newsletter.

    2517(c) Any 2519person 2520substantially affected 2522by the approval or disapproval of a limited-use method 2531may request an administrative hearing as provided in Chapter 120, F.S. 2542Any person substantially affected by the approval or disapproval of a statewide-use method may request an administrative hearing as provided in Chapter 120. F.S., within 21 days of publishing the notice in the Florida Administrative Register, or within 21 days of receipt of the written notice, whichever occurs first.

    2591(9) For requests for the approval of proposed alternative or modified laboratory methods, a2605pplicants who are analyzing discharges regulated under the National Pollutant Discharge Elimination System (NPDES) permit 2620program 2621shall comply with applicable regulations in 262740 CFR Part 136 2631sections 136.4, 136.5 and 136.6 , 2636which are incorporated by reference in subsections 264362-160.800(7)-2644(9), F.A.C., respectively. 2647If requested by the applicant, the Department shall assist the applicant in determining whether an application for approval is required for modifications to methods listed at 267340 CFR, 2675Part 136.3, according to sub-2680subparagraph 268162-160.330(3)(d)2.a., 2682F.A.C.

    2683(10) 2684For requests for the approval of proposed alternative or modified laboratory methods, a2697pplicants who are analyzing compliance samples under the Safe Drinking Water Act shall comply with the applicable provisions in 271640 CFR Part 141, 2720section 141.27, which is incorporated by reference in subsection 272962-160.800(10), 2730F.A.C., 2731and Rule 273362-550.550, 2734F.A.C.

    2735(11) Except for methods promulgated by the United States Environmental Protection Agency in the Federal Register, approval of a laboratory method shall be 2758revoked by the Department 2762if new technical, scientific or regulatory information justifies its revocation. The Department shall use the best scientific and technical information, methods and data in its possession in making the determination to 2793revoke an approved 2796laboratory method.

    2798(a) 2799For a laboratory method that was approved for limited use, the Department shall issue an order revoking approval of the laboratory method to the person who submitted the method. Any additional administrative or scientific information pertinent to the revocation of approval of the method shall be included or incorporated by reference in the order. The order shall be posted on the Department’s website and provided to all persons enrolled to receive the Department’s Quality of Science electronic newsletter. Any person substantially affected by the revocation of approval of the limited-use laboratory method may request an administrative hearing as provided in Chapter 120, F.S.

    2902(b) 2903For a laboratory method that was approved for statewide use, the Department shall issue an order of revoking approval of the laboratory method to the person who submitted the method. Any additional administrative or scientific information pertinent to the revocation of approval of the method shall be included or incorporated by reference in the order. A notice of the order revoking approval of the method shall be published in the Florida Administrative Register. 2976For informational purposes only, 2980the order shall also be posted on the Department’s website and provided to all persons enrolled to receive the Department’s Quality of Science electronic newsletter. Any person substantially affected by the revocation of approval of the statewide-use 3017laboratory method 3019may request an administrative hearing as provided in Chapter 120, F.S., within 21 days of publishing the notice in the Florida Administrative Register, 3042or within 21 days of receipt of the written notice, whichever occurs first3055.

     

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