Fla. Admin. Code Ann. R. 62-160.220 - Approval of Alternative and Modified Field Procedures

(1) Any person or entity may apply for use of a field procedure in place of the approved procedures specified in DEP-SOP-001/01 that is incorporated by reference in paragraph 62-160.800(1)(a), F.A.C., or in place of field procedures that are specified or required in other rules of the Department. Any field procedure proposed for use in place of those specified in DEP-SOP-001/01 or specified or required in other rules of the Department must be approved by the Department prior to use, according to requirements as further described in this rule (Rule 62-160.220, F.A.C.). Field procedures previously approved for use by a contract (including purchase requisitions), order, or permit issued by the Department shall remain approved while such documents remain in effect. In such cases, the documentation that approved the use of the procedure must be retained for at least five years after expiration of the contract, order or permit. Modified or alternative field procedures approved by the Department, but not specified in a contract, purchase requisition, order, or permit, shall remain approved indefinitely, unless revoked, as provided in subsection 62-160.220(9), F.A.C.

(2) Field procedures used in place of those specified in DEP-SOP-001/01 or in place of field procedures specified or required by Department rules, contracts (including purchase requisitions), orders, or permits are designated by the Department as alternative field procedures. Alternative field procedures cannot be approved for any of the following:

(a) The procedures in DEP SOP FT 3000, including all parts and subparts therein, which are contained in DEP-SOP-001/01, which is incorporated by reference in paragraph 62-160.800(1)(a), F.A.C.;

(b) The procedures in DEP SOPs BRN 1000, LVI 1000 and SCI 1000, including all parts and subparts therein, which are contained in DEP-SOP-003/11, which is incorporated by reference in paragraph 62-160.800(1)(c), F.A.C.; and,

(c) The procedures for sampling and the description of data quality objectives and criteria for data usability assessments for the Stream Condition Index (SCI) or a BioRecon determination, as discussed in DEP-SAS-001/11, which is incorporated by reference in paragraph 62-160.800(2)(e), F.A.C., and the Lake Vegetation Index (LVI), as discussed in DEP-SAS-002/11, which is incorporated by reference in paragraph 62-160.800(2)(f), F.A.C.

(3) The Department defines a modification to a field procedure as any change that alters the scope, applicability, specifications, steps, performance criteria, or any other requirements described in the published procedure, and includes those changes described in subsection 62-160.220(4), F.A.C., below. A published procedure is a DEP SOP, a field procedure specified in another Department rule, and other procedures in the scientific or technical literature. Modifications to field procedures are approved by the Department according to the following:

(a) A modification to a procedure that is specifically allowed by instructions in the published procedure is pre-approved by the Department. Any constraints or limits to modifications specified in the original procedure, and any required performance criteria for allowed modifications specified in the procedure shall apply to all pre-approved modifications. The person or organization performing the modified field procedure shall retain all data and documentation demonstrating that the modification produces results that meet data quality objectives established by the Department for a specific use of data. These records shall be retained for at least five years after the last use of the modification for the specific sample(s) affected.

(b) Except for those modifications described in paragraph 62-160.220(3)(a), F.A.C., above, the Department shall determine whether any modifications to a DEP SOP or to a field procedure specified in any other Department rule, contract, order or permit constitute an alternative field procedure, as described in subsections 62-160.220(2), and 62-160.220(4), F.A.C. The Department shall evaluate and approve or disapprove the request according to subsection 62-160.220(4), F.A.C.

(c) The Department shall evaluate and approve or disapprove any modifications to published procedures not pre-approved in paragraph 62-160.220(3)(a), F.A.C., according to the criteria in subsection 62-160.220(4), F.A.C.

(d) The procedures in the DEP SOPs and supporting documents listed in paragraphs 62-160.220(2)(a) -(c), F.A.C., may not be modified, except where allowed according to paragraphs 62-160.220(3)(a) and 62-160.330(3)(a), F.A.C.

(4) A modified or alternative field procedure, as described in subsection 62-160.220(2) or 62-160.220(3), F.A.C., shall be evaluated and approved or disapproved by the Department according to the requirements in subparts FA 2100 and FA 2200 of DEP SOP FA 1000, which is incorporated by reference in subparagraph 62-160.800(1)(a) 1., F.A.C. As further described in the DEP SOP subparts cited above, when evaluating or approving the proposed alternative field procedure, the Department shall consider the following factors and requirements for review of the proposed procedure:

(a) Whether procedural steps, use of equipment, use of reagents, use of technology, or other elements of the field procedure that are proposed are different than those procedures required in the DEP SOPs or different than other procedures required by rules of the Department;

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

(c) Whether the alternative or modified field procedure is demonstrated to be equivalent to or exceeds the performance of the unmodified or replaced DEP SOP or other field procedure specified by a Department rule, contract, order or permit;

(d) Whether the Department cannot grant approval of the alternative or modified field procedure, because use of the alternative procedure 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 field procedures, 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 proposed procedures were developed by consensus or standardization organizations, such as ASTM International, the United States Environmental Protection Agency, or the United States Geological Survey, or developed by manufacturers or vendors from collaborative studies.

(5) Validation documentation shall be submitted to the Department for all proposed alternative field procedures and for all proposed modified field procedures not pre-approved by the Department. All submittals of information for alternative field procedures or modifications to published procedures shall at a minimum be evaluted according to the requirements in subsection 62-160.220(4), F.A.C., above.

(a) The Department's approval of the alternative field procedure or modified published procedure shall be limited to the specific scope and applications that have been identified and validated by the submitted documentation.

(b) The Department shall require documentation as necessary to demonstrate that the modified or alternative procedure produces results that are equivalent to or superior to the originally published procedure when applied to affected samples collected or tested for a specific use of the data generated by the procedure, except where the Department has determined that such performance comparison with the original procedure is not needed for the Department's data quality objectives.

(c) Complete submittals of information supporting requests for alternative field procedures or modifications to published procedures shall be approved if the Department determines that the circumstances for approving the alternative field procedure or modifications to a published procedure are justified, based on the technical merits of the procedure, the adequacy of demonstration or validation data and other supporting information, and the applicability of the alternative field procedure or modified procedure to specific environmental conditions or field sampling designs. In addition, any alternative field procedure or modified procedure must be demonstrated to meet or exceed the data quality objectives established for a specific field application or data use. This demonstration shall take into account specific conditions, such as type of field site, environmental conditions, facility location, specified permit(s), sample collection or field-testing matrix, type of waste stream, and the specific uses of data generated by use of the procedure.

(6) An alternative or modified field procedure 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 modified or alternative field procedure 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 approval. If the submitter is different than the person or organization that performed the validation, then the approval for limited use shall only apply to the person or organization that performed the validation.

(b) For statewide-use methods, the Department shall approve the modified or alternative field procedure for use by all persons and organizations based on the information and data provided to the Department in support of the request for approval. The Department shall require the design of a collaborative study conducted by two or more independent persons or organizations to investigate the efficacy of the proposed statewide-use alternative or modified field procedure for specified site or environmental conditions, sample types, or other specifications applicable to the scope of approval requested. An evaluation of the proposed procedure on multiple sites representing different environmental conditions shall also be required to demonstrate the applicability and efficacy of the procedure. The number of independent persons or organizations required to participate and the number of environmental test sites required for the study shall depend on the statistical robustness determined by the Department to be necessary for the study design, in collaboration with the requestor. 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.

(7) The approval or disapproval of any submitted alternative field procedure or modified published field procedure 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 field procedure to the person or organization who submitted the procedure. Any additional administrative or scientific information pertinent to the approval or disapproval of the procedure shall be included or incorporated by reference in the order. The order and the alternative or modified field procedure shall 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 field procedure to the person or organization who submitted the procedure. Any additional administrative or scientific information pertinent to the approval or disapproval of the procedure shall be included or incorporated by reference in the order. A notice of the order approving or disapproving the procedure shall be published in the Florida Administrative Register. For informational purposes only, the order and the alternative or modified field procedure shall 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 alternative or modified field procedure 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 alternative or modified field procedure 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.

(8) Any alternative or modified field procedure approved for statewide use shall be incorporated into updates of the Department's field sampling procedures (DEP-SOP-001/01). Alternative or modified field procedures approved for limited use shall not be incorporated into DEP-SOP-001/01.

(9) Approval of a field procedure 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 procedure.

(a) For a field procedure that was approved for a limited use, the Department shall issue an order revoking approval of the field procedure to the person or organization who submitted the procedure. Any additional administrative or scientific information pertinent to the revocation of approval of the procedure shall be included or incorporated by reference in the order. The order of revocation 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 a limited-use field procedure may request an administrative hearing as provided in Chapter 120, F.S.

(b) For a field procedure that was approved for statewide use, the Department shall issue an order revoking approval of the field procedure to the person or organization who submitted the procedure. Any additional administrative or scientific information pertinent to the revocation of approval of the procedure shall be included or incorporated by reference in the order. A notice of the order revoking approval of the procedure 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 a statewide-use field procedure 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.

(10) Research field procedures shall be submitted for review and approval according to the requirements 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 procedure(s) shall be submitted for review and approval according to applicable requirements in Rule 62-160.220, F.A.C.

Notes

Fla. Admin. Code Ann. R. 62-160.220

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.

New 1-1-91, Amended 2-4-93, Formerly 17-160.220, Amended 3-24-96, 10-15-96, 4-9-02, 6-8-04, 12-3-08, Amended by Florida Register Volume 40, Number 136, July 15, 2014 effective 7/30/2014, Amended by Florida Register Volume 44, Number 065, April 3, 2018 effective 4/16/2018.

New 1-1-91, Amended 2-4-93, Formerly 17-160.220, Amended 3-24-96, 10-15-96, 4-9-02, 6-8-04, 12-3-08, 7-30-14, 4-16-18.