Approval of New and Alternative Field Procedures, Laboratory Certification, Approval of New and Alternative Laboratory Methods, Record Keeping and Reporting Requirements for Laboratory Procedures, Documents Incorporated by Reference

 

DEPARTMENT OF ENVIRONMENTAL PROTECTION

RULE NOS.:RULE TITLES:

62-160.220Approval of New and Alternative Field Procedures

62-160.300Laboratory Certification

62-160.330Approval of New and Alternative Laboratory Methods

62-160.340Record Keeping and Reporting Requirements for Laboratory Procedures

62-160.800Documents Incorporated by Reference

NOTICE OF CHANGE

Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 43 No. 50, March 14, 2017 issue of the Florida Administrative Register.

The changes were made as the result of comments made by the Florida Joint Administrative Procedures Committee and to correct some renumbered rule references. Rule 62-160.220, F.A.C., was revised to clarify that approved modified or alternative field procedures shall remain approved indefinitely, unless revoked, as provided in subsection 62-160.220(9), F.A.C. Rule 62-160.300, F.A.C., was revised to clarify when Department of Health laboratory certification is not required, because substitute quality assurance requirements will apply.  Subsection 62-160.330(4) and paragraphs 62-160.330(3)(a), 62-160.330(4)(a), and 62-160.330(5)(c), F.A.C., were revised to remove exceptions to the requirement to meet the Department’s data quality objectives. Sub-subparagraph 62-160.330(3)(d)2.b., F.A.C., was revised to indicate the rules where 40 C.F.R, Part 136.3 and 40 C.F.R, Part 136.6 are incorporated by reference. Subparagraphs 62-160.330(3)(d)2. and 3., subparagraph 62-160.330(6)(b)1., and subsection 62-160.330(10), F.A.C., were revised to correct the citations to the subsections that incorporate the indicated documents. Subparagraph 62-160.340(2)(d)3., F.A.C., was revised to identify where DEP-QA-001/01 (January 2017) has been incorporated by reference. Rule 62-160.800, F.A.C., was clarified to add “forms” to the list of incorporated documents. The proposed rule has changed so that when it is adopted it will read:

 

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 previously approved by the Department, but not specified in a contract, purchase requisition, order, or permit, shall remain approved indefinitely, unless revoked, except as provided in subsection 62-160.220(9), F.A.C.

(2) through (10) No change.

 

62-160.300 Laboratory Certification.

(1) Except as provided in subsections 62-160.300(2) through (8), F.A.C., (3), (4) and (5), F.A.C., or other Title 62 rules, all laboratories generating environmental data for submission to the Department or for use in Department-regulated or Department-sponsored activities shall hold certification from the Florida Department of Health, Environmental Laboratory Certification Program (DOH ELCP). Such certification shall be for all matrix/test method/analyte(s) combinations being measured. The matrix of a sample is defined to be the condition under which the laboratory originally receives the sample, and shall be classified according to the Field of Accreditation Matrix groups defined by subsection 62-160.120(18), F.A.C. 

(a) through (d) No change.

(2) No change.

(3) Laboratory certification by the DOH ELCP is not required for the following test procedures identified in subsections 62-550.550(1) and (2), F.A.C., when conducted by an operator licensed under Chapter 62-602, F.A.C., or by persons under the direct supervision of a licensed operator, for the purposes of drinking water compliance:

(a) through (p) No change.

(4) Certification Except for drinking water compliance testing (see subsection 62-160.300(3), F.A.C.), laboratories are not required to be certified by the DOH ELCP is not required when conducting the following test procedures for the analytes listed in paragraphs 62-160.300(4)(a) through (h), F.A.C., because the Department’s standard operating procedures (SOPs) are more stringent than the corresponding laboratory test methods certified by DOH ELCP.  When conducting these test procedures, laboratories shall follow the applicable SOPs in DEP-SOP-001/01 (January 2017), which are incorporated by reference in paragraph 62-160.800(1)(a), F.A.C.:

(a) through (e) No change.

(f) Transparency or light penetration;

(f)(g) Salinity;

(h) Oxidation/reduction potential;

(g)(i) Turbidity; and

(j) Explosive gases (when monitoring for the Lower Explosive Limit);

(k) Sulfite (when performed at the sampling location);

(l) Sediment oxygen demand;

(h)(m) Any other test with a specified specific holding time of fifteen minutes or less when performed as a field procedure. at the sampling location; and,

(n) Any test in which the reported result is a calculation from the results of other tests for which the laboratory holds certification by the DOH ELCP.  When conducting the analyses specified in paragraphs 62-160.300(4)(a) through (n), F.A.C., laboratories shall follow the applicable standard operating procedures in DEP-SOP-001/01 (March 31, 2008). If a method is not listed in DEP-SOP-001/01, the laboratory shall use an approved laboratory method as identified in Rule 62-160.320, F.A.C.

(5) Certification is not required for the following tests or analyses:

(a) Any analyses related solely to internal process control, unless the test data are reported to the Department to meet compliance monitoring requirements for a Department-issued permit;

(b) Geochemical parameters and bacteriological tests conducted at the sampling location for the purposes of evaluating remediation activities;

(c) Those matrix/method/analyte combinations (such as taxonomic identification) that are not included in the DOH ELCP scope of accreditation; however, if the scope of accreditation is uncertain for a specified matrix/method/analyte combination, the Department shall refer the matter of scope of accreditation to the DOH ELCP for a determination;

(b)(d) Laboratory tests conducted for research projects, Research-oriented methods as described in Rule 62-160.600, F.A.C.; or

(c) Methods used by statutorily created volunteer monitoring organizations, when the Department has reviewed and concluded that the organization’s Standard Operating Procedures provide sufficient quality assurance requirements for Department purposes.

(e) Methods approved for a specific purpose if such certification is specifically waived by the Department program for which the method will be used.

(6)(f) Certification by the DOH ELCP is not required for mMethods and procedures required to perform the Specific Oxygen Uptake Rate (SOUR) test, when performed by an operator certified in accordance with Chapter 62-602, F.A.C., or persons under the direction of a certified operator, as authorized by authorized persons according to Chapter 62-640, F.A.C.

(7) Certification is not required for any test in which the reported result is a calculation from the results of other tests for which the laboratory holds certification by the DOH ELCP.

(8) Certification is not required for those matrix/method/analyte combinations (such as taxonomic identification) that are not included in the DOH ELCP scope of accreditation.

(6) If the requirement for certification is only temporarily waived by the Department according to paragraph 62-160.300(5)(e), F.A.C., for expediency in order to meet specific Department project objectives, and the Department has determined that use of the tests for long-term compliance with Department rules is necessary and laboratory certification is required, the laboratory shall apply for certification for the relevant tests and matrices specified in the waiver. In this case, the Department shall establish a deadline to apply for the certification.

(9) (7) If Even if certification is not required (see subsections 62-160.300(3) through (8), (4) and (5), F.A.C.), laboratory organizations shall follow the relevant Department-approved methods as provided in Rule 62-160.320, F.A.C., and shall meet all other requirements for laboratories as provided in this Chapter if applicable to the method(s) included in the waiver. 

 

62-160.330 Approval of Alternative and Modified Laboratory Methods.

(1) through (2) No change.

(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, except when the Department has determined that such performance comparison with the original method is not needed for the Department’s data quality objectives. 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) through (c) No change.

(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. No change.

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)(10), 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)(7), 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. No change.

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)(13), F.A.C. However, this determination shall not supersede any requirements in Department rules, contracts, orders, or permits to use specific methods.

a. through b. No change.

(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, except where the Department has determined that such performance comparison with the original or replaced method is not needed for the Department’s data quality objectives.

(b) No change.

(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) through (b) No change.

(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, except where the Department has determined that such performance comparison with the original method is not needed for the Department’s data quality objectives;

(d) through (e) No change.

(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) No change.

(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)(13), F.A.C.; or,

2. through 3. No change.

(7) through (9) No change.

(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)(11), F.A.C., and Rule 62-550.550, F.A.C.

(11) No change.

 

62-160.340 Record Keeping and Reporting Requirements for Laboratory Procedures.

(1) No change.

(2) When requested by the Department, the laboratory shall provide the Department any records or copies of the records needed to reconstruct analyses, such as:

(a) through (c) No change.

(d) Laboratory quality control information, such as:

1. through 2. No change.

3. Information pertaining to replicate sample analysis including an unambiguous designation of the replicate sample (e.g., sample duplicate, sample matrix spike duplicate, or laboratory control spike duplicate); result of laboratory replicate analysis; replicate precision expressed in terms required by the reported method or as Relative Percent Difference or Percent Relative Standard Deviation (defined in DEP-QA-001/01 (January 2017), which is incorporated by reference in paragraph 62-160.800(1)(a), F.A.C.); and acceptance limits for controlling replicate precision (in-house control limits used by the data generator when control limits are not specified by the reported method or data quality objectives identified by the Department).

(e) through (n) No change.

(3) through (8) No change.

 

62-160.800 Documents Incorporated by Reference.

The following documents, and collections and forms are incorporated herein by reference for use in complying with the requirements of this Chapter. Except as otherwise indicated below, copies of incorporated documents are available for review during normal business hours at the Department of Environmental Protection, Water Quality Standards Program, 2600 Blair Stone Road, Tallahassee, Florida 32399-2400, or may be obtained from the Department’s website at http://www.dep.state.fl.us/water/sas/qa/, or by writing to the Florida Department of Environmental Protection, Water Quality Standards Program, 2600 Blair Stone Road, MS 6511, Tallahassee, FL 32399-2400.

(1) through (13) No change.