The proposed rules update quality assurance requirements for entities providing environmental data to the Department of Environmental Protection (DEP), including field and laboratory Standard Operating Procedures (SOP). The proposed rules, which ...

 

DEPARTMENT OF ENVIRONMENTAL PROTECTION

RULE NO.: RULE TITLE:
62-160.110: Purpose, Scope and Applicability
62-160.120: Definitions and Standards
62-160.210: Approved Field Procedures
62-160.220: Approval of New and Alternative Field Procedures
62-160.240: Record Keeping and Reporting Requirements for Field Procedures
62-160.300: Laboratory Certification
62-160.320: Approved Laboratory Methods
62-160.330: Approval of New and Alternative Laboratory Methods
62-160.340: Record Keeping and Reporting Requirements for Laboratory Procedures
62-160.600: Research Field and Laboratory Procedures
62-160.650: Field and Laboratory Audits
62-160.700: Tables
62-160.800: Documents Incorporated by Reference
PURPOSE AND EFFECT: The proposed rules update quality assurance requirements for entities providing environmental data to the Department of Environmental Protection (DEP), including field and laboratory Standard Operating Procedures (SOP).  The proposed rules, which generally provide clarification and increased flexibility, update various documents incorporated by reference into the rule chapter, clarify when laboratory certification is not required, clarify requirements for approval of new, modified and alternative field and lab procedures, clarify documentation requirements for research activities, and address miscellaneous, minor revisions to various rules within the chapter in response to stakeholder input. 
SUMMARY: The Department is amending Chapter 62-160, F.A.C., to update the Department’s field and laboratory SOPs and quality assurance objectives.  Chapter 62-160, F.A.C., was last updated in 2008.  The proposed rules revise the groundwater sampling SOP to allow a new technique that more accurately collects volatile contaminants, while reducing costs to the regulated community.  A number of SOPs are revised to reflect recent scientific advances.   The proposed rules also clarify when laboratory certification is not required or can be waived in order to meet the specific objectives of a DEP program or project.  There are also proposed revisions that clarify the requirements for requesting use of alternative methodologies and allow more flexibility to use alternative methodologies to facilitate alignment of sampling/testing procedures with scientific advancements.  In addition, there are a number of miscellaneous revisions to documents incorporated by reference based on stakeholder input.  The proposed revisions provide greater flexibility to data providers and are expected to result in reductions in the process and costs for regulated parties, while assuring that DEP receives environmental data of suitable quality for making resource protection decisions.

OTHER RULES INCORPORATING THIS RULE: Chapter 62-160, F.A.C., is referenced by the following rules:   Rules 62-302.540, 62-303.320, 62-303.330, 62-303.340, 62-303.420, 62-303.430, 62-303.460, 62-303.470, 62-330.100, 62-330.412, 62-330.441, 62-341.494, 62-344.400, 62-344.500, 62-4.020, 62-4.246, 62-520.600, 62-610.320, 62-610.463, 62-610.568, 62-610.865, 62-620.610, 62-620.620, 62-625.420, 62-625.600, 62-673.320, 62-673.340, 62-701.200, 62-701.330, 62-701.510, 62-702.400, 62-709.530, 62-713.510, 62-730.225, 62-737.200, 62-770.220, 62-770.900, 62-770.400, 62-770.600, 62-780.220, 62-780.300, 62-780.600, 62-780.700, 62-782.220, 62-782.300, 62-782.600, 62-782.700, 62-785.220, 62-785.300, 62-785.600, and 62-785.700,  F.A.C.

EFFECT ON THOSE OTHER RULES: The proposed amendments are not expected to have significant effects on other rules.  Certain provisions in the proposed rules provide greater flexibility for data providers that should allow for better efficiency and minor cost savings. 

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The Agency has determined that this will have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has been prepared by the agency.  The SERC estimates that the proposed revisions to Rule 62-160 will increase costs for entities conducting Habitat Assessments by $30,388 every five years for training and demonstration of proficiency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: This determination is based upon information contained in the SERC.  Total costs are estimated at $30,388 every five years for training and demonstration of proficiency.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

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, 403.803, 403.853 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW (IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):

DATE AND TIME: November 27, 2012, 1:30 p.m.

PLACE: Florida Department of Environmental Protection, Bob Martinez Center, 2600 Blair Stone Road, Room 609, Tallahassee, FL

Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 5 days before the workshop/meeting by contacting: Michael Blizzard at [phone] or via email at [e-mail]. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Michael Blizzard, Standards and Assessment Section, Florida Department of Environmental Protection, 2600 Blair Stone Road, MS 6511, Tallahassee, FL 32399-2400; telephone [phone], email [e-mail].

THE FULL TEXT OF THE PROPOSED RULE IS:

 

PART I

GENERAL

 

62-160.110 Purpose Scope and Applicability.

(1) through (5)  No change.

(6) If specifically required by the United States Environmental Protection Agency (EPA) for activities conducted for or funded by the EPA, Quality Assurance Project Plans (QAPPs) shall be prepared in accordance with “EPA Requirements for Quality Assurance Project Plans, EPA QA/R-5” (EPA/240/B-01/003 March 2001), which is incorporated by reference in Rule 62-160.800, F.A.C. These QAPPs will be reviewed and approved by the appropriate EPA office or delegated authority.

(7) This chapter supports the Quality Assurance Management Plan required by the EPA for any environmental programs funded in part or in whole by the EPA, as specified in EPA Quality Policy, EPA CIO 2106.0, 10/20/08, Order CIO 2105.9 (formerly 5360.1 A2), dated May 5, 2000, which is incorporated by reference in Rule 62-160.800, F.A.C.

(8)  No change.

 

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 1-1-91, Amended 2-4-93, 2-27-94, Formerly 17-160.110, Amended 3-24-96, 4-9-02, 6-8-04, 12-3-08, _________.

 

62-160.120 Definitions and Standards.

For purposes of this chapter:

(1) “Alternative method” is a field procedure or analytical laboratory method that involves the collection or testing of environmental samples for an analyte (such as a chemical compound, component, or microorganism, etc.) in a specified matrix where a Department-approved method already exists. Approved methods are recognized or specified by the Department according to rules 62-160.210 and 62-160.320, F.A.C.  An alternative method is one intended to be used in place of an existing Department-approved laboratory method or field procedure.

(2)  No change.

(3)  renumbered (4)  No change.

(4)  renumbered (3)  No change.

(5) through (9)  No change.

(10) “Department of Health (DOH) Environmental Laboratory Certification Program (ELCP)” is the state of Florida’s environmental laboratory certification program, authorized by Section 381.00591, F.S., and recognized by the National Environmental Laboratory Accreditation Program (NELAP) Accreditation Council as an authority with responsibility and accountability for granting accreditation for specified fields of laboratory testing through Chapter 64E-1, F.A.C.

(11)through (15) No change.

(16) “Method detection limit (MDL)” is an estimate of the minimum amount of a substance that an analytical process can reliably detect. An MDL is analyte-and matrix-specific and is laboratory-dependent. The MDL for an analyte is determined from the preparation and analysis of a sample in a given matrix containing the analyte. MDLs shall be determined for each matrix/analytical technology/analyte combination reported by the laboratory, except for those tests where determination of the MDL is not appropriate for the analytical technique. MDLs shall be calculated following the procedures specified in “New and Alternative Analytical Laboratory Methods”, DEP-QA-001/01 (February 1, 2004), which is incorporated by reference in Rule 62-160.800, F.A.C., or by any other technically justifiable and scientifically sound method. A specific method must be used when mandated by a Department program.

(17) No change.

(18) “NELAC Field of Accreditation Matrix” is defined in the Glossary of the 2003 2001 NELAC Standards, which is incorporated by reference in Rule 62-160.800, F.A.C., and shall be used to determine matrices under which a laboratory must be certified by the DOH ELCP for reporting data to be used by the Department:

(a)  No change.

(b) Non-potable Water: any aqueous sample excluded from the definition of drinking water matrix including surface water, groundwater, effluents, water treatment chemicals, or samples derived from synthetic precipitation leaching procedures (SPLP), and toxicity characteristic leaching procedures (TCLP) or other extracts. To be considered as non-potable water, water treatment chemicals must be in an aqueous solution. If the laboratory receives the original environmental sample as a solid or chemical material for TCLP extraction, the laboratory must be certified for the TCLP extraction in the Solid and Chemical Material matrix. For the analytical tests to be performed on the TCLP extract, the laboratory must be certified in the non-potable water matrix for at least one method for each analytical technology/analyte combination for each reported analyte.

(c) Solid and Chemical Materials: includes soils, sediments, sludges, products and by-products of an industrial process that results in a matrix not previously defined. For purposes of accreditation, biosolids are considered a solid, unless the sample matrix comprises liquid biosolids as defined in rule 62-640, F.A.C. All other sample matrices not previously defined and comprising ≤ 15% settleable solids are liquids, and may require analysis using techniques for non-potable water or liquid chemical materials.

(d)  No change.

(19) “National Environmental Laboratory Accreditation Conference (NELAC)” was a voluntary organization of state and federal environmental agencies, sponsored by the EPA, and formed to establish and promote mutually acceptable performance standards for the operation of environmental laboratories seeking NELAP accreditation.

(19) (20) “National Environmental Laboratory Accreditation Program (NELAP)” is a program that implements standards that have been found to be acceptable to the NELAP Accreditation Council accrediting authorities.

(21)renumbered (20)  No change.

(21)(22) “New method” is a field procedure or analytical laboratory method that involves the collection or testing of samples for an analyte (such as a chemical compound, component, or microorganism, etc.) in a specified matrix where a Department-approved method does not exist.  Approved methods are recognized or specified by the Department according to rules 62-160.210, F.A.C and 62-160.320, F.A.C.

(23)through (24) renumbered (22) through (23)  No change.

(24)(25) “Practical quantitation limit (PQL)” is the lowest level of measurement that can be reliably achieved during routine laboratory operating conditions within specified limits of precision and accuracy.  The value of the PQL shall be greater that the MDL value except when analytical quality control problems necessitate raising the MDL value equal to or above the PQL value for a specific sample, or when determination of the MDL is not appropriate for an analytical technique.  For Departmental use, if a laboratory fails to report a PQL, the PQL shall be calculated as four times the MDL, except for those tests where determination of the MDL is not appropriate for the analytical technique. In such cases, the Department shall use all available information about the technique to determine the PQL.

(26) through (30)  renumbered (25) through (29)  No change.

(30)(31) “Secondary Use Data Date” means information submitted to the Department that is being considered for use for purposes other than that for which the data were originally generated.

(31)(32) “Site-specific sampling method” is a field method that is validated for the collection of environmental samples from a particular site, waste stream (e.g., facility location), or sample matrix (e.g., effluent, groundwater or drinking water). A site-specific sampling method is approved for use on a specific site by any field organization that is conducting field activities for that site. The approval of a site-specific sampling method does not apply to a sampling organization that wishes to use the method on other sites or intended for other projects. The alternative procedure alternate approval process is outlined in subparts Sections FA 2100 and FA 2200 of FA 1000 of DEP-SOP-001/01 (09-19-2012 March 31, 2008), which is incorporated by reference in Rule 62-160.800, F.A.C.

(33)renumbered (32)  No change.

(33)(34) “Statewide method” is a field procedure or analytical laboratory method that is validated for the collection or testing of environmental samples from similar sites or waste streams within the state of Florida by multiple field sampling organizations or laboratories, as applicable. The process for the validation of a statewide method is outlined in Sections FA 2100 and FA 2200 of FA 1000 (Regulatory Scope and Administrative Procedures for Use of FDEP SOPs) in DEP-SOP-001/01 (March 31, 2008), and “New and Alternative Analytical Laboratory Methods”, DEP-QA-001/01 (February 1, 2004)”, which are incorporated by reference in Rule 62-160.800, F.A.C.

(34)(35) “Surrogate spikes” are samples fortified at known concentration(s) with one or more compounds a compound(s) having similar chemical characteristics to the compounds of interest, but which are not normally found in environmental samples.

 

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 1-1-91, Amended 2-4-93, 2-27-94, Formerly 17-160.120, Amended 3-24-96, 4-9-02, 6-8-04, 12-3-08, _________.

 

PART II

FIELD PROCEDURES

 

62-160.210 Approved Field Procedures.

(1) All persons entities that conduct or support field activites and field measurements shall follow the applicable procedures and requirements described in DEP-SOP-001/01 (09-19-2012 March 31, 2008) and DEP-SOP-003/11 (09-19-2012), which are is incorporated by reference in Rule 62-160.800, F.A.C., unless specifically exempted by the rules of a particular Department program.

(2) Additionally, all persons performing sampling for the Stream Condition Index (SCI), the Lake Vegetation Index or a Rapid Bioassessment (BioRecon) determination shall follow the procedures and satisfy the data quality objectives discussed in the following documents, which are incorporated by reference in Rule 62-160.800, F.A.C.:

(a) Department of Environmental Protection, Sampling and Use of the Stream Condition Index (SCI) for Assessing Flowing Waters: A Primer (DEP-SAS-001/11); and,

(b) Department of Environmental Protection, Sampling and Use of the Lake Vegetation Index (LVI) for Assessing Lake Plant Communities in Florida: A Primer (DEP-SAS-002/11).

(3) (2) Any person party that wishes to apply for new or alternative field procedures other than those specified in DEP-SOP-001/01 (09-19-2012 March 31, 2008) shall follow the requirements provided in Rule 62-160.220, F.A.C.

 

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 1-1-91, Amended 2-4-93, 2-27-94, Formerly 17-160.210, Amended 3-24-96, 10-15-96, 4-9-02, 6-8-04, 12-3-08,   ________.

 

62-160.220 Approval of New and Alternative Field Procedures.

(1) Any party may apply for use of a field procedure other than those specified in DEP-SOP-001/01 (March 31, 2008). Any field procedure not included in DEP-SOP-001/01 (March 31, 2008) must be approved by the Department prior to use according to the requirements of Sections FA 2100 and FA 2200 of FA 1000 of DEP-SOP-001/01 (March 31, 2008). Field procedures approved for use by a contract, order, or permit before the effective date of this chapter shall remain approved for the duration of the project. The documentation that approved the use of the procedure must be retained for at least five years after the last use of the procedure.

(2) Field procedures not included in DEP-SOP-001/01 (March 31, 2008) or not specified by Department contracts, orders or permits, fall into one of the following two categories:

(a)  No change.

(b) Alternative – a field procedure that involves the collection of an analyte (such as a chemical compound, component, or microorganism, etc.) in a specified matrix where a Department-approved procedure already exists. An alternative procedure is one intended to be used in place of an existing Department-approved field procedure. Alternative procedures cannot be approved for the following methods. in DEP-SOP-001/01:

1. The procedures in the following DEP SOPs, which are contained in DEP-SOP-001/01, including all parts and subparts of the methods cited:             

a. FS 7000, General Biological Community Sampling;

b. FS 7100, Phytoplankton Sampling;

c. FS 7220, Qualitative Periphyton Sampling;

d. FS 7230, Rapid Periphyton Survey, and

e. FS 7250, Florida Wetland Condition Index Sampling (Diatoms);

f. FS 7320, Stream and River Linear Vegetation Survey;

g. FS 7330, Florida Wetland Condition Index Sampling (Vegetation);

h. FS 7430, Hester Dendy Sampling;

i. FS 7440, Core Sampling;

j. FS 7450, Dredge Sampling;

1. FS 7410, Rapid Bioassessment (Biorecon) Method;

2. FS 7420, Stream Condition Index (D-Frame Dipnet) Sampling;

k. 3. FS 7460, Lake Condition Index (Lake Composite Sampling);

l. FS 7470, Florida Wetland Condition Index Sampling (Macroinvertebrates); and,

m. 4. FT 3000, Aquatic Habitat Characterization;.

5. FS 7220, Qualitative Periphyton Sampling;

6. FS 7230, Rapid Periphyton Survey, and

7. FS 7310, Lake Vegetation Index Sampling (LVI).

2. The procedures in the following DEP SOPs, which are contained in DEP-SOP-003/11, including all parts and subparts of the methods cited:

a. BRN 1000, BioRecon Determination; 

b. LVI 1000, Lake Vegetation Index; and,

c. SCI 1000, Stream Condition Index. 

3. The discussion of procedures for sampling, description of data quality objectives and criteria for data usability assessments for the Stream Condition Index (SCI), the Lake Vegetation Index or a Biorecon determination in:

a. Department of Environmental Protection, Sampling and Use of the Stream Condition Index (SCI) for Assessing Flowing Waters: A Primer (DEP-SAS-001/11); and,

b. Department of Environmental Protection, Sampling and Use of the Lake Vegetation Index (LVI) for Assessing Lake Plant Communities in Florida: A Primer (DEP-SAS-002/11).

(3) through (9)  No change.

 

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 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,  __________.

 

62-160.240 Record Keeping and Reporting Requirements for Field Procedures.

(1) The record keeping requirements for entities that conduct or support field activities and field measurements are specified in DEP-SOP-001/01 (09-19-2012), including all parts and subparts of DEP SOP FD 1000, and DEP-SOP-003/11 (09-19-2012), including all DEP SOPs, parts and subparts therein applicable to bioassessment field activities FD 1000 (March 31, 2008). The specified records shall contain sufficient information to allow independent reconstruction of all activites related to generating data that are submitted to the Department. These records shall be kept by the generator of the records for a minimum of five years after the date of generation or completion of the records project completion or permit cycle unless otherwise specified in a Department contract, order, permit or Title 62 rules.

(a) Electronic records shall be acceptable as documentation and shall be considered as equivalent in status and function to paper records or documents, unless otherwise specified in a Department contract, order, permit or Title 62 rule.

1. All documentation requirements in this Chapter shall apply equally to paper and electronic records.

2. Electronic copies intended to replace original records shall contain the same information as the original records, regardless of whether the electronic copies are designated as master or duplicate records.

(b) In addition to the requirements in this rule, governmental agencies shall comply with all applicable requirements in the Florida Statutes and the Florida Administrative Code concerning the management, storage and destruction of public records described in this Chapter.

(2) When requested by the Department, the following field sampling information shall be provided to the Department for each site/facility and sampling location, as applicable:

(a)  No change.

(b)  Site and/or facility locational information to include (or as specified by a Department program for indicated projects):

1. through 5.  No change.

(c) Information about the collected samples:

1. through 7.  No change.

8. Any additional information from the field documentation records specified in DEP-SOP-001/01 (09-19-2012 March 31, 2008) and DEP-SOP-003/11(09-19-2012).

(d) Information about field measurement activities:

1. through 3.  No change.

4. Any additional information from the field documentation records specified in DEP-SOP-001/01 (09-19-2012 March 31, 2008).

(e) Information about site conditions:

1. through 2.  No change.

3. Any additional information from the field documentation records specified in DEP-SOP-001/001/01 (09-19-2012 March 31, 2008).

(f) Any additional information specified by the Department in contracts, orders, permits, or Title 62 rules or Department-approved planning documents such as quality assurance plans, sampling and analysis plans, and monitoring plans.

(g) All documentation for new or alternative field procedures as required in rule 62-160.220, F.A.C.

(3)  No change.

(4) When data are provided to the Department in a report that is a summary, a re-published format, or in a reduced form (e.g., report, table, report form), the report shall not change the original data, or delete any data qualifiers reported by the originating field organization unless specified by Department contract, order, permit, or Title 62 rule. Copies (electronic or paper) of the original field report(s) shall be submitted with all such reports unless directed to do otherwise by the Department.

(5) When data qualifiers are added through a validation or review process that is independent of the field reporting process, the reason for the addition, the date of the addition, and the person adding the qualifier(s) shall be included. These qualifiers shall be included in any documents that are summaries or re-published formats, as described in subsection (4) above.

 

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,   _______.

 

PART III

LABORATORY CERTIFICATION AND PROCEDURES

 

62-160.300 Laboratory Certification.

(1) Except as provided in subsections 62-160.300(2), (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 DOH ELCP.

(a)  No change.

(b) For laboratories reporting data for drinking water compliance, certification shall be for all matrix/test text method/analyte(s) combinations being reported.

(c) For the non-potable water matrix, laboratories shall apply for and receive certification in at least one method for each matrix/analytical technology/analyte combination being measured. For informational purposes, the Department shall maintain a list of the acceptable equivalent matrix/analytical technology/analyte combinations and the methods associated with them.

1. When a Department contract, order, permit or Title 62 rule requires a specific method to be reported, laboratories shall report only that method. Laboratories may report additional analytes not published in the reported method, if the applicable requirements in rule 62-160.330, F.A.C. are met, if method(s) for the analyte(s) have not been specified by the Department and the laboratory is certified according to has met the certification requirement of paragraph 62-160.300(1)(c), F.A.C.

2. Except as noted in sub-paragraph 62-160.300(1)(c)1., F.A.C., above, laboratories may report results by any method that is equivalent in technology to the method for which they hold certification, provided they are certified for the analyte that is reported. When laboratories report a method for which they do not hold certification, the laboratory shall document that all ensure that all the requisite quality control and calibration requirements of the reported method are met.

3. If a laboratory is required to provide data for an analyte for which, according to subsection 62-160.320(1), F.A.C., no method is published for  exists in the non-potable water matrix, or the published method for the non-potable water matrix does not meet required data quality objectives established by the Department for a program or project, but a method is published exists for the drinking water matrix, and the Department has recognized that the published drinking water method meets the data quality objectives for the Department program or project for which the method will be used according to subsection 62-160.320(1), F.A.C., the laboratory is not required to obtain certification for the analytical technology/analyte combination in the non-potable water matrix the laboratory is not required to obtain certification for the method-technology/analyte combination in the non-potable water matrix. However, the laboratory must be certified in the drinking water matrix for the reported test method/analyte combination.

(d)  No change.

(2) To the extent possible, a laboratory must be certified as specified in subsection 62-160.300(1), F.A.C., before reporting results for a given matrix/analytical technology or test method/analyte combination. However, if a laboratory makes a written request to the Department to use a method that is not certified, a Department program will allow a laboratory to begin using a method before the certification process is complete if the laboratory wishes to add an analyte to a matrix/analytical technology or test method combination that is already certified; or if the laboratory is certified for a specific matrix/analytical technology or test method/analyte combination and wishes to add the capability of analyzing samples using the same analytical technology or test method/analyte combination in a different matrix.

(a) through (b)  No change.

(c) The laboratory shall notify the Department program of the status of its certification application within 5 business days of  receiving notification within 90 days of the on-site visit by DOH ELCP of the certification status inspectors.

(3) Laboratory certification by the DOH ELCP is not required for the following test procedures when conducted for the purposes of drinking water compliance:

(a) through (k)  No change.

(l) Total organic carbon; or

(m) Turbidity; or .

(n) Any analytes in addition to those listed in paragraphs 62-160.300(3)(a) through 62-160.300(3)(m), F.A.C., above that are exempted from laboratory certification according to subsections 62-550.550(1) and 62-550.550(2), F.A.C., for the specific compliance applications described therein.

(o) The analytes exempted in paragraphs 62-160.300(3)(a) through 62-160.300(3)(n), F.A.C., above shall be analyzed according to all applicable requirements for analyses according to subsections 62-550.550(1) and 62-550.550(2), F.A.C., for the specific compliance applications described therein.

(p) In cases where the Department has a specific field testing method standard operating procedure (e.g., FT 1100 for pH, in DEP-SOP-001/01), the laboratory or authorized person, as described in Rule 62-550.550, F.A.C., shall follow the Department’s procedures. For all other analytes, a laboratory or authorized person, as described in rule 62-550.550, F.A.C., shall only use test methods that are acceptable for drinking water compliance, as specified in Rule 62-550.550, F.A.C. and shall follow all requirements for calibration verification according to DEP SOP FT 1000 in DEP-SOP-001/01.

(4) 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 when conducting the following test procedures:

(a) through (b)  No change.

(c) Specific conductance conductivity;

(d) through (n)  No change.

(5) Certification is not required for:

(a) through (b)  No change.

(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;

(d)  No change.

(e) Methods approved developed for site-specific, limited-use purpose if such certification is specifically waived by the Department program for which the method will be used.

(f) Methods and procedures required to perform the Specific Oxygen Uptake Rate (SOUR) test, when performed by authorized persons according to Chapter 62-640, F.A.C.

(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 program or project objectives, the laboratory shall apply for certification for the relevant tests and matrices specified in the waiver, if the Department has determined that use of the tests for long-term compliance with Department rules is necessary. In this case, the Department shall establish a deadline for applying for the certification.

(7) (6) Even if certification is not required (see subsections 62-160.300(3), (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., as applicable. In addition, the laboratory shall operate a quality assurance program consistent with the quality systems requirements standards of the TNI Standard EL-V1M2-2011, and as NELAC specified in Chapter 64E-1, F.A.C.

 

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, 403.803, 403.853, 403.803 FS. History–New 1-1-91, Amended 2-4-93, 2-27-94, Formerly 17-160.300, Amended 3-24-96, 4-9-02, 6-8-04, 12-3-08,   ________.

 

62-160.320 Approved Laboratory Methods.

(1) Approved laboratory methods are specified in the Department’s program rules, contracts, orders or permits. When methods are specified by a Department program, rule, contract, order or permit, only those methods shall be used. For informational purposes, the Department maintains lists a list of methods, and method compendiums and publication sources that have been recognized by various Departmental programs. When laboratory methods are not specified in Department rules, contracts, orders or permits, applicable methods from the list of recognized methods are approved, where the methods are determined by a Department program to satisfy data quality objectives established for the Department program or project. However, these lists this list shall not supersede or limit the use of other methods that are required by contract, order, permit or Title 62 rule. Upon request, the lists this list will be provided by the Department, 2600 Blair Stone Road, Tallahassee, Florida 32399-2400. A link for the lists of methods is posted on the Department’s webpage at http://www.dep.state.fl.us/water/sas/qa/am-sources.htm. The Environmental Protection Agency published updated lists of analytical methods in Guidelines Establishing Test Procedures for the Analysis of Pollutants Under the Clean Water Act; Analysis and Sampling Procedures, Final Rule, Federal Register, Vol. 77, No. 97, Friday, May 18, 2012, Rules and Regulations, pp. 29758–29846, which is incorporated by reference in Rule 62-160.800, F.A.C. 

(a) On March 12, 2007, and March 26, 2007, the Environmental Protection Agency published updated lists of methods to be used by laboratories reporting data under the Clean Water Act and Safe Drinking Water Act (Federal Register, Vol. 72, No. 47 and Vol. 72, No. 57, respectively), which are incorporated by reference in Rule 62-160.800, F.A.C. These lists withdrew many older methods.

(b) Laboratories that are certified under the withdrawn method(s) shall apply for and receive certification for a method to take the place of the withdrawn method(s). Laboratories shall be certified for the replacement method(s) within six (6) months after the effective date of this rule.

(2) Except as specified in subsections (3) and (4) below, lLaboratories performing taxonomic identification for periphyton or benthic macroinvertebrates macrobenthic invertebrates shall use the procedures in the following DEP SOPs, which are contained in DEP-SOP-002/01 and incorporated by reference in Rule 62-160.800, F.A.C.:

(a) For taxonomic identification of periphyton, LQ 1000 shall be used, including part LQ 7000, and subparts LQ 7100 through LQ 7140;

(b) For taxonomic identification of benthic macroinvertebrates, LQ 1000 shall be used, including part LQ 7000, and subparts LQ 7400 through LQ 7420.

DEP-SOP-002/01, Method LQ 7000 (found in LQ 1000), which is incorporated by reference in Rule 62-160.800, F.A.C.

(3) Laboratories performing taxonomic identifications or calculations for calculating the Stream Condition Index (SCI), the Lake Condition Index, the Lake Vegetation Index or making a Biorecon determination shall use the procedures in the following DEP SOPs, which are contained in DEP-SOP-003/11 and incorporated by reference in Rule 62-160.800, F.A.C.:

(a) For the Stream Condition Index, SCI 1000 shall be used (including part SCI 2000 and subparts SCI 2100 through SCI 2230);

(b) For the Lake Vegetation Index, LVI 1000 shall be used (including part LVI 2000 and subparts LVI 2100 through LVI 2210);

(c) For the BioRecon determination, BRN 1000 shall be used (including part BRN 2000 and subparts BRN 2100 through BRN 2110).

follow DEP-SOP-002/01, Methods LD 7000 and LT 7000 found in LD 1000 and LT 1000 respectively, which are incorporated by reference in Rule 62-160.800, F.A.C.

(4) Additionally, laboratories or persons performing taxonomic identifications, calculations or data usability assessments for the Stream Condition Index (SCI), the Lake Vegetation Index or a BioRecon determination shall follow the procedures and satisfy the data quality objectives discussed in the following documents, which are incorporated by reference in Rule 62-160.800, F.A.C.:

(a) Department of Environmental Protection, Sampling and Use of the Stream Condition Index (SCI) for Assessing Flowing Waters: A Primer (DEP-SAS-001/11);

(b) Department of Environmental Protection, Sampling and Use of the Lake Vegetation Index (LVI) for Assessing Lake Plant Communities in Florida: A Primer (DEP-SAS-002/11).

(5) Laboratories calculating the Lake Condition Index (LCI) shall use the procedures in DEP SOP LT 7000 (including subparts LT 7010, LT 7020, LT 7030, LT 7040, LT 7300 and LT 7900), which are contained in DEP-SOP-002/01 and incorporated by reference in Rule 62-160.800, F.A.C.

(6) Laboratories calculating the Wetland Condition Indices (WCI) shall use the procedures in DEP SOP subpart LT 7600, including all subparts as listed below, which are contained in DEP-SOP-002/01 and incorporated by reference in Rule 62-160.800, F.A.C.:

(a) For the determination of Wetland Condition Index for freshwater isolated herbaceous wetlands, DEP SOP subpart LT 7610 shall be used (including subparts LT 7611 and LT 7612).

(b) For the determination of Wetland Condition Index for freshwater isolated forested wetlands, DEP SOP subpart LT 7620 shall be used (including subparts LT 7621 and LT 7622).

 

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 12-3-08,   _______.

 

62-160.330 Approval of New and Alternative Laboratory Methods.

(1) Any person party may apply for use of a laboratory method other than those described in subsection 62-160.320(1), F.A.C. specified in the Department’s contracts, orders, permits, or Title 62 rules.  Laboratory methods that have been approved for use in a contract, order, permit or Title 62 rule, or approved by a Department program to meet established data quality objectives according to subsection 62-160.320(1), F.A.C., before the effective date of this chapter shall remain approved. The documentation that approved the use of the method procedure must be retained for at least five years after the last use of the method procedure.

(2) All new and alternative laboratory methods that support a Department contract, order, permit or Title 62 rule must be approved by the Department prior to use. These methods fall into one of two categories:

(a) New – an analytical laboratory method that tests for an analyte (such as a chemical compound, component, or microorganism, etc.) in a specified matrix, and where a Department-approved method has not been specified, recognized or approved by the Department according to subsection 62-160.320(1), F.A.C. does not exist;

(b) Alternative – an analytical laboratory method that tests for an analyte (such as a chemical compound, component, or microorganism, etc.) in a specified matrix, and is intended to be used in place of a method that has been specified, recognized or approved by the Department according to subsection 62-160.320(1), F.A.C. where a Department-approved method does exist. An alternative method is one intended to be used in place of an existing Department-approved method.  Alternative methods procedures cannot be approved for the following:

1. Any method Alternatives to methods that the United States Environmental Protection Agency has designated for analysis of a as “method-defined analyte”; and

2. The following methods from DEP-SOP-002/01, including all subparts of the methods cited LT 1000:

a. LT 7100, Biorecon Determination;

b. LT 7200, Stream Condition Index (SCI) Determination;

c. renumbered a.  No change.

b. LT 7600, Wetland Condition Indices Determinations.

d. LT 7500 Lake Vegetation Index (LVI) Determination.

3. The following methods from DEP-SOP-003/11, including all parts and subparts of the methods cited:

a. BRN 1000, Biorecon Determination;

b. SCI 1000, Stream Condition Index (SCI) Determination;

c. LVI 1000, Lake Vegetation Index (LVI) Determination.

(3) A method modification is any modification to a published an approved analytical laboratory method that changes the scope and applicability, specifications, procedures, performance criteria or requirements contained in the method, as applicable to the analytes and matrices for which the method was originally published. A published method is any method specified, recognized or approved by the Department according to subsection 62-160.320(1), F.A.C., or otherwise available to the public in the scientific literature. A modified method must satisfy the data quality objectives established by the Department program for which the modifed method will be used. Additionally, validation of the modified method shall demonstrate that the modified method produces equivalent or superior analytical performance, as compared to the unmodified method, where applicable to the analyte and matrix for which the modifed method will be used. is specifically allowed by the approved method.

(a) Upon review of any request to use a modified method, the Department shall determine whether the proposed modified method is a new method or alternative method, according to subparagraphs 62-160.330(2)(a) or 62-160.330(2)(b)., F.A.C. All proposals to use modified methods as new methods or alternative methods shall include the submittal of method validation documentation to the Department. Modified methods that are not determined to be new or alternative methods do not require submittal of method validation documentation, as indicated in paragraph (b) below. Methods listed in subparagraphs 62-160.330(2)(b)1. – 62-160.330(2)(b)3., F.A.C., may not be modified.

(b) Except as indicated in paragraph (c) below, mMethod modifications specifically allowed by the published method are not considered alternative methods and do not require submittal of method validation documentation to approval by the Department prior to use. However, the laboratory shall retain all data that demonstrate that the modification meets the Department’s data quality objectives established for the Department program or project for which the method will used, and Department approval is limited to the specific method scope and modifications validated by the laboratory. In addition, the laboratory shall document initial and ongoing performance of the method modification, where such demonstration is required by the original, unmodified published method, and, as otherwise required in sections 1.5 and 1.6 of the TNI Standard EL-V1M4-2011, when laboratory certification is required according to Rule 62-160.300, F.A.C. All method validation records shall be retained for at least five years after the last use of the modification.  produces equivalent results to the unmodified method.  These records shall be retained for at least five years after the last use of the modification.

1. Except as indicated in subparagraph 62-160.330(2)(b)1., F.A.C., allowable modifications described by the Environmental Protection Agency (EPA) at 40 CFR, Part 136.6 are applicable to the methods listed at 40 CFR, Part 136.3. 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. Where 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.

2. Except as indicated in subparagraph 62-160.330(2)(b)1., F.A.C, the Department has determined that methods published by the Environmental Protection Agency (EPA) in Test Methods for Evaluating Solid Waste, Physical/Chemical Methods (SW-846), may be modified, where appropriate to achieve data quality objectives for a Department program or project, when such modifications are made according to the information and requirements concerning method modifications contained in the SW-846 collection of methods. However, this determination shall not supersede any requirements in Department rules, contracts, orders or permits to use specific methods.

(c) If the modified method will be used as an alternative method as described in subsection 62-160.320(2), F.A.C., the method validation shall demonstrate that the modified method produces equivalent or superior analytical performance in meeting the data quality objectives established for the Department program or project, as compared to the method for which it is proposed as an alternative. Validation documentation shall be submitted to the Department according to subsection 62-160.330(4), F.A.C.

(4) New and alternative methods shall be demonstrated as appropriate for use according to the requirements in New and Alternative Analytical Laboratory Methods, DEP-QA-001/01 (February 1, 2004) unless otherwise specified in a Department contract, order, permit or Title 62 rule. Where applicable, any additional demonstrations of initial and ongoing performance shall also be evaluated and documented for the new or alternative method, where such demonstration is required by an original, published method, including a published method that has been modified, and, as otherwise required in sections 1.5 and 1.6 of the TNI Standard EL-V1M4-2011, when laboratory certification is required according to Rule 62-160.300, F.A.C. Except as indicated in paragraph 62-160.330(2)(b), F.A.C., method validation documentation shall be submitted to the Department for review and approval. The submitted method validation documentation for a A new or alternative laboratory method shall be evaluated by the Department based on its intended use:

(a) No change.

(b) Statewide-Use Method – the laboratory method is intended for testing environmental samples from similar matrices, sites or waste streams within the state of Florida by multiple laboratories. For a statewide method, the Department requires an interlaboratory collaborative study following the specifications in Appendix D of the Official Methods of Analysis of the Association of Official Analytical Chemists (1995), incorporated by reference in Rule 62-160.800, F.A.C. Alternatively, an interlaboratory collaborative study that is designed based on procedures published by a nationally recognized consensus-based standards organization (e.g., American Society for Testing and Materials) may be used. Specifications for these studies are provided in DEP-QA-001/01 (February 1, 2004).

(5) through (6)  No change.

(7) Applicants who are analyzing discharges regulated under the National Pollutant Discharge Elimination System (NPDES) permit system shall comply with applicable provisions of the United States Environmental Protection Agency (EPA) regulations in 40 CFR Part 136 paragraphs 136.4, 136.5 and 136.6 (2012 2008). Applicants shall submit the application to the Department, which shall forward the application to the United States Environmental Protection Agency Administrator of Region 4 for review and approval. The determination for approval or rejection shall be made by the United States Environmental Protection Agency. If requested by the applicant, the Department shall assist the applicant in determining whether an application is required for modifications to methods listed at 40 CFR, Part 136.3, according to subparagraph 62-160.330(2)(b)1., F.A.C.

(8) Applicants who are analyzing compliance samples under the Safe Drinking Water Act shall comply with the applicable provisions of the United States Environmental Protection Agency regulations (40 CFR Part 141 paragraph 27 127) and Department Rule 62-550.550, F.A.C. Use of an alternative analytical technique requires written permission from the Department and United States Environmental Protection Agency.

(9)  No change.

 

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,   _______.

 

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

(1) Laboratory record keeping requirements shall follow those specified by the DOH ELCP Chapter 64E-1, F.A.C., and this chapter.  Records shall be retained for a minimum of five years after the date of project completion or permit cycle unless otherwise specified in a Department contract, order, permit or Title 62 rules.  The laboratory records shall contain sufficient information to allow independent reconstruction of all activities related to generating data that are submitted to the Department. In addition, the laboratory shall ensure that its records include all information necessary to support the analytical report (subsection 62-160.340(2), F.A.C.). When requested by the Department, the laboratory shall provide applicable records or copies of the records to the Department. These records shall include, but are not limited to:

(a) The laboratory records shall contain sufficient information to allow independent reconstruction of all activities related to generating data that are submitted to the Department.

(b) In addition, the laboratory shall ensure that its records include all information necessary to support the analytical report (subsection 62-160.340(3), F.A.C.).

(c) Records shall be retained for a minimum of five years after the date of generation or completion of the records unless otherwise specified in a Department contract, order, permit or Title 62 rules. 

(d) Electronic records shall be acceptable as documentation and shall be considered as equivalent in status and function to paper records or documents, unless otherwise specified in a Department contract, order, permit or Title 62 rule.

1. All documentation requirements in this Chapter shall apply equally to paper and electronic records.

2. Electronic copies intended to replace original records shall contain the same information as the original records, regardless of whether the electronic copies are designated as master or duplicate records.

(e) In addition to the requirements in this rule, governmental agencies shall comply with all applicable requirements in the Florida Statutes and the Florida Administrative Code concerning the management, storage and destruction of public records described in this Chapter.

(2) When requested by the Department, the laboratory shall provide applicable records or copies of the records to the Department. These records shall include, but are not limited to:

(a) Laboratory and project information including:

1. Signed and dated final report (laboratory analytical report) as specified in subsection (3) (2) below;

2. through 8.  No change.

(b) Sample receipt, preparation and analysis information including:

1. through 5.  No change.

6. Analysis records of original data. Original data is information generated at the time of or as the result of performing laboratory procedures or tests; e.g., “raw” data automatically reported or logged from analytical instrumentation, such as strip chart recordings or chromatograms; handwritten laboratory notes, laboratory notebooks or drawings; completed laboratory forms or bench sheets; and photographs.  Original analysis records such as strip chart recordings, laboratory notebooks, chromatograms, etc.

(c) through (j)  No change.

(k) Field quality control results including trip blanks, field blanks, equipment blanks, and field replicates as required by DEP-SOP-001/01 (09-19-2012 March 31, 2008), DEP-SOP-003/11 (09-19-2012) or the applicable contract, order, permit, or Title 62 rule; and

(l) Any additional elements specified by the Department in contracts, orders, permits, or Title 62 rules, or Department-approved planning documents such as quality assurance plans, sampling and analysis plans, and monitoring plans;.

(m) All documentation for modified, new and alternative methods, as required in rule 62-160.330, F.A.C.; and

(n) Any additional records required in DEP-SOP-002/01 (09-19-2012), including DEP SOP LD 1000 and all parts and subparts of LD 1000 therein; and, any additional records required in DEP-SOP-003/11 (09-19-2012), including all DEP SOPs, parts and subparts therein, as applicable to the documentation of bioassessment activities.

(3)(2) Except as noted in subsection (4) (3) below, a laboratory shall generate an analytical report that is consistent with the requirements of the DOH ELCP Chapter 64E-1, F.A.C., and section 5.10 of TNI Standard EL-V1M2-2011, 5.5.10.5 and 5.5.10.6 of 2003 NELAC Standards which is (incorporated by reference in Rule 62-160.800, F.A.C.), The report shall contains all applicable reporting elements specified in and shall otherwise comply with requirements specified in Sections 5.10 through 5.10.11 5.5.10.3 and 5.5.10.4 of TNI Standard EL-V1M2-2011, Module 2 (General Quality Systems Requirements) the 2003 NELAC Standards, and shall use uses the applicable qualifiers as defined in Table 1: Data Qualifier Codes (Rule 62-160.700, F.A.C.). In addition to the stated requirements, laboratories shall ensure that the following requirements are met or reported:

(a) through (e)  No change.

(4) (3) Laboratories that are operated by a facility and whose sole function is to provide data to the facility management for compliance purposes (i.e., in-house or captive laboratories as described in section 5.10.10 5.5.10.1 of TNI Standard EL-V1M2-2011, Module 2 (General Quality Systems Requirements), the 2003 NELAC Standard shall meet the requirements specified in that standard 5.5.10.1 of the NELAC Standard.

(4) renumbered (5)  No change.

(6) (5) Once issued, a laboratory report is considered final and shall not be amended. Amendments or corrections to a final laboratory report shall be made in accordance with the requirements of section 5.10.9 of TNI Standard EL-V1M2-2011, Module 2 (General Quality Systems Requirements) 5.5.10.8 of the 2003 NELAC Standard.

(6) through (7) renumbered (7) through (8)  No change.

 

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,   ________.

 

PART IV

MISCELLANEOUS

 

62-160.600 Research Field and Laboratory Procedures.

(1) through (2)  No change.

(3) All research field sampling and laboratory procedures shall be described in a Department-approved work or study plan or in direct contract language.  The following minimum elements shall be addressed, as applicable:

(a) through (e)  No change.

(f) Identification of any specialized training or certification needed by personnel in order to successfully complete the project or task.  This requirement includes specifying any laboratory certification requirements as provided in Rule 62-160.300, F.A.C.  The Department project manager may waive the requirement for laboratory certification as provided in paragraph 62-160.300(5)(e), F.A.C.  Regardless of a this waiver of the certification requirement, laboratories conducting work for a research project these projects shall operate a quality assurance program consistent with the quality systems standards of The NELAC Institute (TNI Standard EL-V1M2-2011), which are incorporated by reference into this Chapter.  The Department shall assist the researcher in determining which specific TNI standards are relevant to the research project.  the NELAC specified in Chapter 64E-1, F.A.C.

(g) through (h)  No change.

(4)  No change.

 

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 1-1-91, Amended 2-4-93, 2-27-94, Formerly 17-160.600, Amended 3-24-96, 10-15-96, 4-9-02,   ________.

 

62-160.650 Field and Laboratory Audits.

(1) through (2)  No change.

(3) Upon request, the audited field sampling organization, individual, consultant or responding responsible party shall provide copies of all applicable records as specified in Rule 62-160.240, F.A.C. Sufficient information shall be provided to enable the auditor to independently reconstruct all field procedures related to the project.

(4) Upon request, the audited laboratory, individual, consultant or responding responsible party shall provide copies of those applicable records as specified in Rule 62-160.340, F.A.C. Sufficient information shall be provided to enable the auditor to independently reconstruct all laboratory procedures related to the project.

(5) Within ninety (90) days of the audit, the Department shall provide a preliminary audit report to the audited field sampling or laboratory organization, individual, consultant or responding party (“audited party”, hereinafter). The audited party shall have forty-five (45) days thereafter to respond with a detailed plan of corrective actions and an implementation schedule for the deficiencies that were noted in the preliminary audit report; justification for noted deficiencies that will not be addressed or corrected; and any corrections or rebuttals to the audit findings. If different than the above, a Department program shall specify in rules, contracts, orders or permits any alternative schedules and procedures for the distribution of preliminary audit reports to designated recipients and for any required corrective action plans or other responses from designated respondents.

(6)  No change.

(7) Once a response has been received, the Department shall evaluate the response for technical applicability and completeness. The Department will issue a final response to the audited party and any affected organization or individual laboratory that specifies acceptance or rejection of the audited party’s plan of corrective actions, provides recommendations concerning the usability of the audited data, and includes a statement of any substantially affected person’s rights under Chapter 120, F.S. If different than the above, a Department program shall specify in rules, contracts, orders or permits any alternative schedules and procedures for the distribution of the Department’s final response to designated recipients, to include acceptance or rejection of the audited party’s plan of corrective actions, recommendations concerning the usability of the audited data and any other relevant information. Any substantially affected organization or person (e.g., field sampling or laboratory organization, individual, consultant, responding party, affected permittee, or facility owner/operator, laboratory, or field sampling consultant) may request an administrative hearing as provided in Chapter 120, F.S., within 21 days of receipt of the final response.

(8) The requirements in subsections 62-160.650(4) through 62-160.650(7), F.A.C shall not apply to field proficiency audits of organizations or persons conducting field bioassessment procedures according to DEP SOPs BRN 1000, LVI 1000 or SCI 1000 (DEP-SOP-003/11).

 

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 1-1-91, Formerly 17-160.650, Amended 3-24-96, 4-9-02, 12-3-08,   ________.

 

62-160.700 Tables.

The following table has been referenced in this chapter and is identified by this title:

Table 1: Data Qualifier Codes.

Table 1

DATA QUALIFIER CODES

The following codes shall be used by laboratories and/or field organizations when reporting sample data values that either meet the specified descriptions outlined below or do not meet the applicable quality control criteria specified for of the laboratory or field result. Data qualifier codes listed in summary reports or other presentations comprising information that has been reformatted from original reports generated by field or laboratory organizations or individuals shall meet the requirements of subsections 62-160.240(4) and 62-160.340(7), F.A.C. Data qualifier codes added to sample results during data review procedures conducted by organizations or individuals other than the generators of original reports shall meet the requirements of subsections 62-160.240(5) and 62-160.340(8), F.A.C.

 

_____________________________________________________________________________________________

SYMBOL MEANING

____________________________________________________________________________________________

CODE	DEFINITION
A	Value reported is the arithmetic mean (average) of two or more determinations. This code shall be used if the reported value is the average of results for two or more discrete and separate samples. These samples shall have been processed and analyzed independently. Do not use this code if the data are the result of replicate analysis on the same sample aliquot, extract or digestate.
B	Results based upon colony counts outside the acceptable range. This code applies to microbiological tests and specifically to membrane filter colony counts. The code is to be used if the colony count is generated from a plate in which the total number of coliform colonies is outside the method indicated ideal range. This code is not to be used if a 100 mL sample has been filtered and the colony count is less than the lower value of the ideal range.
F	When reporting species: F indicates the female sex.
H	Value based on field kit determination; results may not be accurate. This code shall be used if a field screening test (e.g., i.e., field gas chromatograph data, immunoassay, or vendor-supplied field kit, etc.) was used to generate the value and the field kit or method has not been recognized by the Department as equivalent to laboratory methods.
I	The reported value is greater than or equal to the laboratory method detection limit but less than the laboratory practical quantitation limit.
J	Estimated value. A “J”-qualified sample value shall be accompanied by a detailed explanation to justify the reason(s) for designating the value as estimated. Where possible, the organization shall report whether the actual sample value is estimated to be less than or greater than the reported value, to assist data users in any evaluation of the usability of the sample value. A “J” data qualifier code value shall not be used as a substitute for G, K, L, M, S, T, V, or Y, however, if additional reasons exist for identifying the value as an estimate (e.g., laboratory control spike or matrix spiked failed to meet acceptance criteria), the “J” code may be added to a G, K, L, M, T, U, V, or Y qualifier. Examples of situations in which a “J” code must be reported include: instances where a quality control item associated with the reported value failed to meet the established quality control criteria (the specific failure must be identified); instances when the sample matrix interfered with the ability to make any accurate determination; instances when data are questionable because of improper laboratory or field protocols (e.g., composite sample was collected instead of a grab sample); instances when the analyte was detected at or above the method detection limit in an analytical laboratory blank other than the method blank (such as a calibration blank) or field-generated blanks and, the value of 10 times the blank value is was equal to or greater than 10% of the associated sample value); or, instances when the field or laboratory calibrations or calibration verifications did not meet calibration acceptance criteria, including quantitative or chronological bracketing requirements for field testing data.
K	Off-scale low. Actual value is known to be less than the value given. This code shall not be used for microbiological tests or for biochemical oxygen demand. This code shall not be used for field-testing measurements where quantitative bracketing is required. This code shall be used if:
	1. The value is less than the lowest calibration standard and the calibration curve is known to be non-linear; or
	2. The value is known to be less than the reported value based on sample size, dilution.
	This code shall not be used to report values that are less than the laboratory practical quantitation limit or laboratory method detection limit.
L	Off-scale high. Actual value is known to be greater than value given. This code shall not be used for microbiological tests or biochemical oxygen demand. This code shall not be used for field-testing measurements where quantitative bracketing is required. To be used when the concentration of the analyte is above the acceptable level for quantitation (exceeds the linear range or highest calibration standard) and the calibration curve is known to exhibit a negative deflection.
M	When reporting chemical analyses: presence of material is verified but not quantified; the actual value is less than the value given. The reported value shall be the laboratory practical quantitation limit. This code shall be used if the level is too low to permit accurate quantification, but the estimated concentration is greater than or equal to the method detection limit. If the value is less than the method detection limit use “T” below.
N	Presumptive evidence of presence of material. This qualifier shall be used if:
	1. The component has been tentatively identified based on mass spectral library search; or
	2. There is an indication that the analyte is present, but quality control requirements for confirmation were not met (i.e., presence of analyte was not confirmed by alternative procedures).
O	Sampled, but analysis lost or not performed.
Q	Sample held beyond the accepted holding time. This code shall be used if the value is derived from a sample that was prepared or analyzed after the approved holding time restrictions for sample preparation or analysis.
T	Value reported is less than the laboratory method detection limit. The value is reported for informational purposes only and shall not be used in statistical analysis.
U	Indicates that the compound was analyzed for but not detected. This symbol shall be used to indicate that the specified component was not detected. The value associated with the qualifier shall be the laboratory method detection limit. Unless requested by the client, less than the method detection limit values shall not be reported (see “T” above).
V	A “V”-qualified sample value iIndicates that the analyte was detected at or above the method detection limit in both the sample and the associated method blank and the value of 10 times the blank value was equal to or greater than 10% of the associated sample value. The 10% criterion shall not apply to blank results for biochemical oxygen demand (BOD) or microbiological tests. For BOD tests, the “V” code shall be used for all sample results where the associated method blank result exceeds the maximum blank DO depletion specified in the analytical method. For microbiological tests, the “V” code shall be used for all samples where the associated method blank indicates growth of the target organism. Note: unless specified by the method, the value in the blank shall not be subtracted from associated samples.
X	Indicates, when reporting results from a Stream Condition Index Analysis (SCI 1000 LT 7200 and FS 7420), that insufficient individuals were present in the sample to achieve a minimum of 280 organisms for identification (the method calls for two aliquots of 140-160 organisms), suggesting either extreme environmental stress or a sampling error.
Y	The laboratory analysis was from an improperly preserved sample. The data may not be accurate.
Z	Too many colonies were present for accurate counting. Historically, this condition has been reported as “too numerous to count” (TNTC). The “Z” qualifier code shall be reported when the total number of colonies of all types is more than 200 in all dilutions of the sample. When applicable to the observed test results, a numeric value for the colony count for the microorganism tested shall be estimated from the highest dilution factor (smallest sample volume) used for the test and reported with the qualifier code. Atypical, non-target, spreading colonies or other interferences may prevent estimation of typical target organism counts.
?	Data are rejected and should not be used. Some or all of the quality control data for the analyte were outside criteria, and the presence or absence of the analyte cannot be determined from the data.
*	Not reported due to interference.

 

The following codes deal with certain aspects of field activities. The codes shall be used if the laboratory has knowledge of the specific sampling event. The codes shall be added by the organization collecting samples if they apply:

 

SYMBOL MEANING
CODE	DEFINITION
D	Measurement was made in the field (i.e., in situ). This code applies to any value (except field measurements of pH, specific conductance, dissolved oxygen, temperature, total residual chlorine, transparency, turbidity or salinity) that was obtained under field conditions using approved analytical methods. If the parameter code specifies a field measurement (e.g., “Field pH”), this code is not required.
E	Indicates that extra samples were taken at composite stations.
G	A “G”-qualified sample value indicates that the analyte was detected at or above the method detection limit in both the sample and the associated field blank, equipment blank, or trip blank, and the blank value was greater than 10% of the associated sample value. The value in the blank shall not be subtracted from associated samples.
R	Significant rain in the past 48 hours. (Significant rain typically involves rain in excess of 1/2 inch within the past 48 hours.) This code shall be used when the rainfall might contribute to a lower or higher than normal value.
S	Secchi disk visible to bottom of waterbody.  The value reported is the depth of the waterbody at the location of the Secchi disk measurement.
!	Data deviate from historically established concentration ranges.

 

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 1-1-91, Amended 2-4-93, 2-27-94, Formerly 17-160.700, Amended 3-24-96, 4-9-02, 6-8-04, 12-3-08,   _________.

62-160.800 Documents Incorporated by Reference.

(1) Specific references to the documents listed below are made throughout this chapter and are incorporated by reference.

(a) Department of Environmental Protection Standard Operating Procedures for Field Activities, DEP-SOP-001/01 (09-19-2012 March 31, 2008), Florida Department of Environmental Protection, Standards and Assessment Section.

(b) Department of Environmental Protection Standard Operating Procedures for Laboratory Activities, DEP-SOP-002/01 (09-19-2012 March 31, 2008), Florida Department of Environmental Protection, Standards and Assessment Section.

(c) Department of Environmental Protection, Standard Operating Procedures Selected Bioassessment Activities, DEP-SOP-003/11 (09-19-2012), Florida Department of Environmental Protection, Standards and Assessment Section.

(c) through (f) renumbered (d) through (g) No change.

(g) Guidelines Establishing Test Procedures for the Analysis of Pollutants Under the Clean Water Act; National Primary Drinking Water Regulations; and National Secondary Drinking Water Regulations; Analysis and Sampling Procedures, Final Rule, Federal Register, Vol. 72, No. 47, Monday March 12, 2007 pp. 11200–11249.

(h) Guidelines Establishing Test Procedures for the Analysis of Pollutants; Analytical Methods for Biological Pollutants in Wastewater and Sewage Sludge; Final Rule, Federal Register, Vol. 72, No. 57, Monday March 26, 2007 pp. 14220–14233.

(h)(i) EPA Quality Policy and Program Requirements for the Mandatory Agency-Wide Quality System, EPA Order CIO 2106.0 2105.0 (formerly 5360.1 A2), 10/20/08 May 5, 2000, United States Environmental Protection Agency.

(i) The NELAC Institute (TNI), EL-V1M2-2011, Environmental Laboratory Sector, Vol. 1, Management and Technical Requirements for Laboratories Performing Environmental Analyses, Module 2: Quality Systems General Requirements.

(j) 2003 NELAC Standards, EPA/600/R-04/003, June 5, 2003, United States Environmental Protection Agency.

(j)(k) Glossary, Appendix A to Chapter 1, Program Policy and Structure, 2003 NELAC Standards, Approved July 5th, 2003, EPA/600/R-04/003.  of the 2001 NELAC Standards, EPA/600/R-01/100, May 2001, United State Environmental Protection Agency.

(k) Department of Environmental Protection, Sampling and Use of the Stream Condition Index (SCI) for Assessing Flowing Waters:  A Primer (DEP-SAS-001/11).

(l) Department of Environmental Protection, Sampling and Use of the Lake Vegetation Index (LVI) for Assessing Lake Plant Communities in Florida: A Primer (DEP-SAS-002/11).

(m) Guidelines Establishing Test Procedures for the Analysis of Pollutants Under the Clean Water Act; Analysis and Sampling Procedures, Final Rule, Federal Register, Vol. 77, No. 97, Friday, May 18, 2012, Rules and Regulations, pp. 29758–29846.

(2)  No change.

 

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,   ________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Drew Bartlett

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Herschel T. Vinyard Jr.

DATE PROPOSED RULE APPROVED BY AGENCY HEAD:  October 8, 2012

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: September 9, 2011