62-160.330. Approval of Alternative and Modified Laboratory Methods

(1) Any person may apply for use of a laboratory method in place of the approved methods described in subsection 62-160.320(1), F.A.C. Any laboratory method proposed for use in place of those described in subsection 62-160.320(1), F.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. Laboratory methods that have been previously approved for use in a Department rule, contract, order, or permit shall 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 approved by the Department to meet established data quality objectives according to subsection 62-160.320(1), F.A.C., and alternative or modified laboratory methods previously approved by the Department shall remain approved, except as provided in subsection 62-160.330(9), F.A.C.

(2) Laboratory 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. Alternative laboratory methods that support a Department rule, contract, order, or permit must be approved by the Department prior to use. Alternative laboratory methods cannot be approved for the following:

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

(b) The following methods from DEP-SOP-002/01 (January 2017), which is incorporated by reference in subparagraph 62-160.800(1)(b)3., F.A.C., including all subparts of the methods cited:

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

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

(c) The laboratory 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, which is incorporated by reference in paragraph 62-160.800(1)(c), F.A.C.

(3) The Department defines a laboratory method modification as any change to a published analytical laboratory method that alters 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 analytical laboratory method specified, recognized or approved by the Department according to subsection 62-160.320(1), F.A.C., or other procedures in scientific journals or other technical literature.

(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 performed; and the laboratory shall retain all data that demonstrate that the modification meets the Department’s data quality objectives. 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. These 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.

(b) Upon review of any request to use a modified method, the Department shall determine whether the proposed modified method constitutes an alternative method according to subsection 62-160.330(2), F.A.C. All proposals to use modified methods as alternative methods shall include the submittal of method validation documentation to the Department according to the requirements in subsection 62-160.330(4), F.A.C.

(c) Methods listed in paragraphs 62-160.330(2)(a) – 62-160.330(2)(c), F.A.C., shall not be modified.

(d) When method modifications are specifically allowed as indicated in subparagraphs 62-160.330(3)(d)1. – 62-160.330(3)(d)3., F.A.C., below, submittal of method validation documentation to the Department prior to use is not required, and such modifications are pre-approved by the Department. When laboratory certification is required according to Rule 62-160.300, F.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, which is incorporated by reference in paragraph 62-160.800(3)(b), F.A.C. 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.

1. 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.

2. Allowable modifications described by the Environmental Protection Agency (EPA) at 40 CFR, Part 136.6, which is incorporated by reference in subsection 62-160.800(9), F.A.C., apply to the methods listed at 40 CFR, Part 136.3, which is incorporated by reference in subsection 62-160.800(6), F.A.C., and are pre-approved by the Department. In accordance with 40 CFR, Part 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.

a. The Department shall consider all interpretations of 40 CFR Part 136.6 as 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 40 CFR, Part 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. However, this determination shall not supersede any requirements in Department rules, contracts, orders, or permits to use specific methods.

b. Allowable modifications described in 40 CFR, Part 136.6 shall apply to other approved methods that are not listed in 40 CFR, Part 136.3, which is incorporated by reference in subsection 62-160.800(6), F.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 40 CFR, Part 136.6, which is incorporated by reference in subsection 62-160.800(9), F.A.C., to other methods according to sub-subparagraph 62-160.330(3)(d)2.a., F.A.C., above. If the Department determines that the requested modifications meet Department data quality objectives according to 40 CFR Part 136.6 requirements 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.

3. The Department has determined that methods published by the Environmental Protection Agency (EPA) in the collection titled “Test Methods for Evaluating Solid Waste, Physical/Chemical Methods (SW-846)” may be modified to achieve Department data quality objectives when such modifications are made 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 subsection 62-160.800(11), F.A.C. However, this determination shall not supersede any requirements in Department rules, contracts, orders, or permits to use specific methods.

a. 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.

b. The provisions for use of modified methods in sub-subparagraph 62-160.330(3)(d)3.a., F.A.C., above, shall not supersede requirements in subparagraph 62-160.330(3)(d)2., F.A.C., above.

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

(a) Validation 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.

(b) When validation documentation must be submitted to the Department, alternative laboratory methods and modifications to published laboratory methods shall be demonstrated as appropriate for use according to the requirements in DEP-QA-001/01, which is incorporated by reference in subsection 62-160.800(5), F.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 62-160.300, F.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, which is incorporated by reference in paragraph 62-160.800(3)(b), F.A.C. 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.

(5) When 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:

(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 subsection 62-160.320(1), F.A.C;

(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;

(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;

(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 62-160.670, F.A.C., below; and,

(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.

(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:

(a) For limited-use methods, the 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. A 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 62-160.330, F.A.C.).

(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:

1. 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 62-160.800(12), F.A.C., or

2. 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).

3. Further description and specifications for these studies are provided in DEP-QA-001/01, which is incorporated by reference in subsection 62-160.800(5), F.A.C.

(7) Research methods shall be submitted for review and approval according to the requirements provided in Rule 62-160.600, F.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 requirements of Rule 62-160.330, F.A.C.

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

(a) For limited-use methods, the Department shall issue an order of approval or disapproval of the alternative or modified laboratory method 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 or modified laboratory method 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.

(b) For statewide-use methods, the Department shall issue an order of approval or disapproval of the alternative or modified laboratory method 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. A notice of the order approving or disapproving the method shall be published in the Florida Administrative Register. For informational purposes only, the order and the alternative or modified laboratory method 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.

(c) Any person substantially affected by the approval or disapproval of a limited-use method may request an administrative hearing as provided in Chapter 120, F.S. Any 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.

(9) For requests for the approval of proposed alternative or modified laboratory methods, applicants who are analyzing discharges regulated under the National Pollutant Discharge Elimination System (NPDES) permit program shall comply with applicable regulations in 40 CFR Part 136 sections 136.4, 136.5 and 136.6 , which are incorporated by reference in subsections 62-160.800(7)-(9), F.A.C., respectively. If 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 40 CFR, Part 136.3, according to sub-subparagraph 62-160.330(3)(d)2.a., F.A.C.

(10) For requests for the approval of proposed alternative or modified laboratory methods, applicants who are analyzing compliance samples under the Safe Drinking Water Act shall comply with the applicable provisions in 40 CFR Part 141, section 141.27, which is incorporated by reference in subsection 62-160.800(10), F.A.C., and Rule 62-550.550, F.A.C.

(11) Except for methods promulgated by the United States Environmental Protection Agency in the Federal Register, approval of a laboratory method shall be revoked by the Department if 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 revoke an approved laboratory method.

(a) For 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.

(b) For 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. For informational purposes only, the 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 laboratory 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.

Rulemaking Authority 403.061, 403.0623 FS. Law Implemented 373.026, 373.309, 373.409, 373.413, 373.414, 373.416, 373.4592, 376.303, 376.305, 376.3071, 403.0623, 403.0625, 403.087, 403.088, 403.0881, 403.504, 403.704, 403.707, 403.722, 403.853 FS. History–New 4-9-02, Amended 6-8-04, 12-3-08, 7-30-14, 4-16-18.