The purpose of this rulemaking is to update the Department’s Standard Operating Procedures (SOPs) for Field Activities (DEP-SOP-001/01) and Laboratory Activities (DEP-SOP-002/01). The majority of these updates are intended to clarify and/or correct ...

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
62-160.400: Sample Preservation and Holding Times
62-160.405: Electronic Signatures
62-160.650: Field and Laboratory Audits
62-160.670: Data Validation by the Department
62-160.700: Tables
62-160.800: Documents Incorporated by Reference
PURPOSE AND EFFECT: The purpose of this rulemaking is to update the Department’s Standard Operating Procedures (SOPs) for Field Activities (DEP-SOP-001/01) and Laboratory Activities (DEP-SOP-002/01). The majority of these updates are intended to clarify and/or correct procedures in the original documents, and should have minimal effect on a majority of laboratory or field operations. There are, however, a limited number of new Standard Operating Procedures for conducting and interpreting biological assessments, which represent recent advances in environmental science. As part of this rulemaking, the Department is also clarifying the process by which data usability is assessed in a new document, which will be incorporated by reference, titled “Department of Environmental Protection Process for Assessing Data Usability”, (DEP-EA-001/07).
SUMMARY: Changes in the rule include updating the reference dates of DEP-SOP-001/01 and DEP-SOP-002/01; clarifying the applicability of the rule to include all organizations that are a part of the sample collection/laboratory analysis process; identifying new and revised standard operating procedures for biological assessments in DEP-SOP-001/01 and DEP-SOP-002/01 (Qualitative Periphyton Sampling , Rapid Periphyton Survey, Lake Vegetation Index sampling and calculation, Stream Condition Index calculation and BioRecon index calculation); simplifying the accreditation requirements for laboratories needing certification in non-potable water for multiple methods of the same analytical technology; allowing use of drinking water methods for non-potable water analysis when no other methods exist; identifying additional tests for which certification is not required; adding more detail to the records to be maintained by laboratories; modifying the content requirements for laboratory reports; adding prohibitions against altering data that were originally generated by another party; adding performance criteria for electronic signatures; modifying Table 1 62-160.700, F.A.C., with clarifications and additions; and updating the documents incorporated by reference. The changes in the SOPs are intended to clarify the original intent of certain procedures, or to provide more detailed information. The new SOPs related to the various biological indices are necessary to ensure that these procedures for assessment, processing, and calculation are consistent among all parties performing them.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: A Statement of Estimated Regulatory Cost was prepared and is available upon request. The Department’s analysis concluded that the proposed rule will not result in net cost increases to the regulated public. Specifically, several revisions allow for increased laboratory certification flexibility and reduction of certification requirements for selected analytes, which could result in minor cost savings for affected parties. Provision of the performance standards for authentication of electronic signatures will also provide cost benefits to affected parties because they will facilitate use of electronic signatures, which are faster than a hard copy method. Several of the revisions are cost neutral changes, such as extensions/clarifications of existing requirements or descriptions of FDEP data evaluation procedures. The only proposed revisions that may increase costs slightly are those associated with the new biological index procedures, which require parties currently engaged in bioassessment activities to invest additional time to ensure that results submitted to the Department are scientifically reliable.
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.
SPECIFIC AUTHORITY: 403.061, 403.0623, 668.006 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, 403.783, 403.853, 668.006, 668.50 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: Wednesday, July 23, 2008, 3:00 p.m.
PLACE: Room A204, Bob Martinez Center, 2600 Blair Stone Road, Tallahassee, Florida
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: Bureau of Personnel Services at (850)245-2511. If you are hearing or speech impaired, please contact the agency by 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: Amanda Cantrell, Florida Department of Environmental Protection, 2600 Blair Stone Road, MS 6511, Tallahassee, Florida 32399-2400, (850)245-8065, amanda.cantrell@dep.state.fl.us.

THE FULL TEXT OF THE PROPOSED RULE IS:

62-160.110 Purpose, Scope and Applicability.

(1) The purpose of this chapter is to assure that chemical, physical, biological, microbiological and toxicological data used by the Department are appropriate and reliable, and are collected and analyzed by scientifically sound procedures. To this end, this chapter defines the minimum field and laboratory quality assurance, methodological and reporting requirements of the Department.

(2) Except as provided in subsection (3) of this section, this chapter shall apply to all programs, projects, studies or other activities that are required by the Department, and that involve the measurement, use or submission of environmental data or reports to the Department. This chapter shall apply to all entities that participate in the process of generating environmental data. This process includes, but is not limited to: field activities (sample collection, sample preservation, field measurements, and site evaluation); sample handling, storage and/or transport (except common carriers); laboratory activities (e.g., sample receipt, analysis, data review and data validation); additional data review, summaries or data presentation activities; and all activities that impact data quality such as providing sample containers, instrument calibration services, or reagents and standards (except commercial vendors).

(3) Programs, projects, studies or activities pertaining to air quality, meteorology, atmospheric radiation, atmospheric noise, electric and magnetic fields or air pollutant emissions, and having no requirements for monitoring contamination of soil, or ambient water, or tissue are excluded from the scope of this chapter. These excluded activities include those specified in Chapters 62-204, 62-210, 62-212, 62-213, 62-214, 62-252, 62-296 and 62-297 (Air Resources Management), F.A.C.

(4) through (5) No change.

(6) If specifically required by the United States Environmental Protection Agency (EPA) for activities conducted for or funded by 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), EPA/240B-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) through (8) No change.

Specific 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, 403.783, 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,_________.

62-160.120 Definitions and Standards.

For purposes of this chapter:

(1) through (2) No change.

(3) “Common Carrier” is a business or agency that is available to the general public for the transportation of goods over a definite route and according to a regular schedule. “Chemical Abstracts Service (CAS) Registry Number” is a unique number assigned to a chemical by the Chemical Abstracts Service Registry. The CAS is a division of the American Chemical Society and is internationally recognized as the producer of the largest and most comprehensive database of chemical information. The CAS Registry Number provides an unambiguous way to identify a chemical substance or molecular structure.

(4) “Commercial Vendor” is a retail or wholesale company whose business is to sell commodities to customers and who is not a part of the process that generates environmental data. These businesses do not include organizations that purchase commodities with the intent of providing the commodities as a service to clients.

(5)(4) “Data quality objectives” are a set of qualitative and quantitative statements derived from a systematic planning process that clarify the purpose of the study, define the most appropriate type of information to collect, determine the most appropriate conditions from which to collect that information, and specify tolerable levels of potential decision errors requirements that environmental data must achieve to be acceptable for use in a specific program or project.

(5) through (8) renumbered (6) through (9) No change.

(10)(9) “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) as an authority with responsibility and accountability for granting accreditation for specified fields of laboratory testing through Chapter 64E-1, F.A.C. The standards used by the DOH ELCP are those established by the National Environmental Laboratory Accreditation Conference (NELAC) or The NELAC Institute, as specified in Chapter 64E-1, F.A.C.

(11) “Electronic signature” means an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record.

(10) through (12) renumbered (12) through (14) No change.

(15)(13) “Method-defined analyte” is defined by the U.S. Environmental Protection Agency as an analyte whose result is totally dependent on how the measurement is made. Any changes or modifications in the preparation or determinative techniques of these methods have the potential of changing the result. Examples are Carbonaceous Biological Oxygen Demand, Oil and Grease, and Toxicity Characteristic Leaching Procedure (TCLP).

(16)(14) “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 minimum concentration of an analyte of interest that can be measured and reported with 99% confidence that the analyte concentration is greater than zero. 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. MDLs shall be calculated shall be determined 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 unless otherwise specified by a mandated test method for which the laboratory is certified or seeking certification.

(17)(15) “Method modification” is any modification to an approved field procedure or analytical laboratory method that is specifically allowed by the approved field procedure or analytical laboratory method.

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

(a) Drinking Water: any aqueous sample that has been collected from a water source designated by the Department as a potable or potential potable water source.

(b) Non-potable Water: any aqueous sample excluded from the definition of drinking water matrix including. Includes surface water, groundwater, effluents, water treatment chemicals, 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 be certified in the non-potable water matrix for at least one method for each analytical technology/analyte combination for each reported analyte and TCLP or other extracts must have been received by the laboratory as the extract, otherwise, the original environmental sample shall determine the field of accreditation matrix.

(19)(17) “National Environmental Laboratory Accreditation Conference (NELAC)” was is 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. These standards cover both analytical testing of environmental samples and the laboratory accreditation process. The goal of NELAC is to foster the generation of environmental laboratory data of known and documented quality through the adoption of national performance standards for environmental laboratories and other entities directly involved in the environmental field measurement and sampling process.

(20)(18) “National Environmental Laboratory Accreditation Program (NELAP)” is a the program that implements standards that have been found to be acceptable to the NELAP accrediting authorities the NELAC standards. NELAP is administered by the EPA.

(19) through (26) renumbered (21) though (28) No change.

(27) “Rejection” of data means the Department shall not use the data for the program or project for which they were generated. If the data do not comply with the validation criteria specified in subsection 62-160.670(1), F.A.C., they shall be subject to rejection in part or in whole for use by Department programs, as provided in subsections 62-160.670(2) and (3), F.A.C.

(28) through (29) renumbered (29) through (30) No change.

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

(32)(30) “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 alternate approval process is outlined in Sections FA 2100 and FA 2200 of FA 1000 of DEP-SOP-001/01 (March 31, 2008 February 1, 2004), which is incorporated by reference in Rule 62-160.800, F.A.C.

(33)(31) “Spike” is an environmental sample that has been fortified with a known chemical of interest, at a known concentration. The purpose of a spike is to determine the method recovery efficiency for the chemical of interest, at the fortified concentration level, in the particular environmental sample of interest.

(34)(32) “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 FA 2100 and FA 2200 of DEP-SOP-001/01 (March 31, 2008 February 1, 2004), 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.

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

62-160.210 Approved Field Procedures.

(1) All entities that conduct or support field activities and field measurements field sampling organizations shall follow the applicable procedures collection and quality control protocols and requirements described in DEP-SOP-001/01 (March 31, 2008 February 1, 2004), which is incorporated by reference in Rule 62-160.800, F.A.C., unless specifically exempted by the rules of a particular Department program.

(2) Any party that wishes to apply for new or alternative field procedures other than those specified in DEP-SOP-001/01 (March 31, 2008 February 1, 2004) shall follow the requirements provided in Rule 62-160.220, F.A.C.

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 February 1, 2004). Any field procedure not included in DEP-SOP-001/01 (March 31, 2008 February 1, 2004) must be approved by the Department prior to use according to the requirements of Subsections FA 2100 and FA 2200 of FA 1000 of in DEP-SOP-001/01 (March 31, 2008 February 1, 2004). 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 February 1, 2004) or not specified by Department contracts, orders, or permits, fall into one of the following two categories:

(a) New – a field procedure that involves the collection of an analyte (chemical compound, component, microorganism, etc.) in a specified matrix where a Department-approved field procedure does not exist.

(b) Alternative – a field procedure that involves the collection of an analyte (chemical compound, component, 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 and DEP-SOP-002/01:

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

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

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

4. FT 3000, Aquatic Habitat Characterization Assessment;

5. FS 7220, Qualitative Periphyton Sampling;

6. FS 7230, Rapid Periphyton Survey; and

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

(3) A procedure modification to an approved field procedure that is specifically allowed by the approved procedure is are not considered an alternative or new procedures and does do not require approval by the Department prior to use. However, the entity performing the modified procedure field sampling organization shall retain all data that demonstrate that the modification produces equivalent results when applied to the relevant sample matrix. These records shall be retained for at least five years after the last use of the modification.

(4) though (8) No change.

Specific 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, 403.783, 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,_________.

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

(1) The All record keeping requirements for entities that conduct or support field activities and field measurements field sampling organizations are specified in DEP-SOP-001/01 FD 1000 (March 31, 2008 February 1, 2004). The specified records shall contain sufficient information to allow independent reconstruction of all activities 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 project completion or permit cycle unless otherwise specified in a Department contract, order, permit, or Chapter Title 62 rules.

(2) When requested by the Department, If specified by the Department in a contract, order, permit, or other Title 62 rule, the following field sampling information shall be provided to the Department for each site/facility and sampling location, as applicable:

(a) Project information including:

1. Project and/or program identification or name; and

2. Site and/or facility name, address and phone number.;

(b) Site and/or facility locational information to include:

1. through 3. No change.

4. Spheroid – the ellipsoid used as a model for the surface of the Earth; and

5. Geolocational collection information:

a. through e. No change.

f. Coordinate accuracy level – the measured, estimated or deduced degree of correctness of the measurement; and

g. Verification information including name of the person verifying the measurement, the date and the time when verification was performed.;

1. through 6. No change.

7. Unambiguous identification of all field-generated quality control samples such as field or equipment blanks, replicate samples or split samples; and

8. Any additional information from the field documentation records specified in DEP-SOP-001/01 (March 31, 2008 February 1, 2004.

(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 (March 31, 2008 February 1, 2004).

(e) Information about site conditions:

1. Weather;

2. Flow (including units); and

3. Any additional information from the field documentation records specified in DEP-SOP-001/001/01 (March 31, 2008 February 1, 2004).; and;

(f) Any additional information specified by the Department in contracts, orders, permits or Chapter Title 62 rules.

(3) No change.

62-160.300 Laboratory Certification.

(1) Except as provided in subsections 62-160.300(2), (3), (4) and (5), F.A.C., or other Chapter 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) Certification shall be based on the matrix of the sample. 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 NELAC Field of Accreditation Matrix groups defined by subsection 62-160.120(18), F.A.C.

(b) For laboratories reporting data for drinking water compliance, Such certification shall be for all matrix/test method/analyte(s) combinations being reported 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 NELAC Field of Accreditation Matrix groups defined by subsection 62-160.120(16), F.A.C.

(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 Chapter 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 method(s) for the analyte(s) have not been specified by the Department and the laboratory has met the certification requirement of paragraph 62-160.300(1)(c), F.A.C.

2. Except as noted in subparagraph 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 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 no method exists in the non-potable water matrix, but exists for the drinking 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 method/analyte combination.

(d) For all other matrices, laboratories shall apply for and receive certification for all matrix/test method/analyte combinations that are reported to the Department.

(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 may 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) The laboratory must have met all the requirements for certification except for the on-site visit by DOH ELCP inspectors. The laboratory must be prepared to provide to the Department copies of the relevant application, applicable performance test sample results and the initial demonstration of capability., and

(b) The precision, accuracy and method detection limits generated by the laboratory must meet or exceed the project-specific data quality objectives.

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

(3) No change.

(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 (h) No change.

(i) Turbidity (when performed at the sampling location);

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

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

(l) Sediment oxygen demand; and

(m) Any other test with a specific holding time of fifteen minutes or less when performed 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 However, these laboratories shall follow the applicable standard operating procedures in DEP-SOP-001/01 (March 31, 2008 February 1, 2004). 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. when conducting the analyses specified in paragraphs 62-160.300(4)(a) through (m), F.A.C.

(5) Certification is not required for:

(a) Any analyses related solely to internal process control;

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

(6) No change.

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’s maintains a list of methods and method compendiums that have been recognized by various Departmental programs. However, this list shall not supersede or limit the use of other methods that are may be required by contract, order, permit or Chapter Title 62 rule. Upon request, this list will be provided by A copy of this list may be obtained from the Department, Florida Department of Environmental Protection, Environmental Assessment Section, 2600 Blair Stone Road, MS 6511, Tallahassee, Florida 32399-2400.

(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) Laboratories performing taxonomic identification for periphyton or macrobenthic invertebrates shall use 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 calculating the Stream Condition Index (SCI), the Lake Condition Index, the Lake Vegetation Index or making a Biorecon determination shall 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.

62‑160.330 Approval of New and Alternative Laboratory Methods.

(1) No change.

(2) All laboratory methods that support a Department contract, order, permit or Chapter 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 (chemical compound, component, microorganism, etc.) in a specified matrix where a Department-approved method does not exist;

(b) Alternative – an analytical laboratory method that tests for an analyte (chemical compound, component, microorganism, etc.) in a specified matrix 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 procedures cannot be approved for:

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

2. The following methods from DEP-SOP-002/01, LT 1000:

a. LT 7100, Biorecon Determination;

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

c. LT 7300, Lake Condition Index (LCI) Determination; and

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

(3) No change.

(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 Chapter Title 62 rule. A new or alternative laboratory method shall be evaluated based on its intended use:

(a) Limited-Use Method – the laboratory method is intended only for testing environmental samples from a particular site, waste stream (e.g., facility location) or sample matrix (e.g., effluent, groundwater or drinking water). A limited-use method is validated by a single laboratory and shall may only be used by that laboratory.

(b) Statewide-Use Method – the laboratory method is intended for testing environmental samples from similar 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)., incorporated by reference in Rule 62-160.800, F.A.C.

(5) No change.

(6) 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 regulations in 40 CFR Part 136 paragraphs 136.4 and 136.5 as updated by the Federal Register, Vol. 72, No. 47 (2000). 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.

(7) No change.

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 Chapter 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) Laboratory and project information including:

1. Signed and dated final report as specified in paragraph (2) below;

2. Project information such as client name, site name, client project number, or client project name;

3. When applicable, the quality assurance project plan associated with the project;

4. Client or field identification number for each sample;

5. Date and time of sample collection;

6. Sample matrix (e.g., groundwater, effluent, waste, soil, etc.);

7. Sample type (e.g., environmental sample, field blank, matrix spike); and

8. Identification of all laboratories providing analytical results in the report and the appropriate laboratory certification numbers from the DOH ELCP (if applicable) for each laboratory.

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

1. Laboratory identification number for each sample fraction;

2. Sample receipt conditions such as proper and intact custody seals;

3. Positive verification of chemical and/or physical sample preservation during sample receipt and/or before sample analysis. The information shall include the preservation acceptance criteria, an indication of acceptability, and the value(s) if the criteria are not met;

4. Sample preparation information, if applicable, including method, date of sample preparation and time of sample preparation if the holding time specified in Rule 62-160.400, F.A.C., is less than or equal to 72 hours;

5. Sample analysis information including analytical method, date of sample analysis, and time of sample analysis if the holding time specified in Rule 62-160.400, F.A.C., is less than or equal to 72 hours; and

6. Original analysis records such as strip chart recordings, laboratory notebooks, chromatograms, etc.

1. Analyte or organism name as applicable;

2. Test result with all applicable data qualifiers, as specified in Table 1: Data Qualifier Codes;

3. Test result units;

4. Other sample characteristics such as percent moisture or fraction (i.e., total or dissolved); and

5. Textual comments, if applicable, that specify any deviations (such as failed quality control), additions to, or exclusions from, the analytical method, and any non-standard conditions (such as sample matrix or environmental conditions) that have affected the quality of results.

(d) Laboratory quality control information including:

1. Identification that unambiguously links groups of samples to a specified set of activities such as preparation, analysis, shipping, reporting, or quality control;

2. Laboratory blank results (results for any laboratory blank analysis as required by the DOH ELCP certification or the analytical method); and

3. Information pertaining to replicate sample analysis including an unambiguous designation of the replicate sample (e.g., sample duplicate, sample matrix spike duplicate, laboratory control spike duplicate, etc.); 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 (February 1, 2004)); 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) Instrument Calibration/Verification including:

1. Number of standards;

2. Acceptability requirements for initial calibration, and initial and continuing calibration verifications; and

3. Origin, and preparation (if applicable) for all standards used for calibration.

(f) For chemical testing:

1. When applicable, indication that a sample was filtered in the laboratory;

2. For each analyte, records to support:

a. When applicable, determination of method detection limit(s) and practical quantitation limit(s) including the method by which each are determined; the raw and processed data supporting the determination(s); and effective dates; and

b. Dilution factor (if applicable).

3. Matrix or laboratory control spike information including concentration level (level of analyte added to a spiked sample), matrix or laboratory control spike recovery (results for matrix spike/duplicate sample analysis including those required by methods) and matrix or laboratory control spike recovery limits (in-house recovery limits used by the data generator when control limits are not specified by the reported method or data quality objectives identified by the Department); and

4. When performed, surrogate spike information including concentration level (level of analyte added to the sample), surrogate spike recovery, and surrogate recovery limits (in-house recovery limits used by the data generator when control limits are not specified by the reported method or data quality objectives identified by the Department).

(g) For microbiological testing:

1. Results of all applicable reagent or dilution water quality or suitability test associated with samples;

2. Results of all media quality control tests; and

3. Sample ID of sample used to verify positive results and results of such verifications.

(h) For toxicity (bioassay) testing:

1. Test type (acute or chronic);

2. Test organism(s) used;

3. Age(s) of test organism(s);

4. Test result(s);

5. Statistical method used to generate the result(s);

6. Control data (mortality/weight/reproduction, etc.) as appropriate to test type;

7. Test end points and confidence intervals;

8. Standard reference toxicant data associated with batch of test organisms; and

9. Physical and chemical measures that are associated with the test (pH, temperature, dissolved oxygen, etc.).

(i) For benthic invertebrate taxonomic identification:

1. Sorting efficiency, as percent (%);

2. Number and identity of taxa in sample;

3. Percent agreement between or among identifications performed by two or more independent taxonomists associated with the period when results were generated;

4. Indication of which organisms were verified against standard reference collection; and

5. Indication of whether the organism range includes Florida.

(j) For algal taxonomic identification:

1. Percent agreement between or among identifications performed by two or more independent taxonomists associated with the period when results were generated;

2. Number and identity of taxa in the sample;

3. Microscope magnification;

4. Dilution factor;

5. Surface area sampled (periphyton) or volume sampled (phytoplankton);

6. Number of fields counted; and

7. Counting chamber dimensions.

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

(l) Any additional elements specified by the Department in contracts, orders, permits, or Chapter 62 rules.

(2) Except as noted in Subsection (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 5.5.10.5 and 5.5.10.6 of 2003 NELAC Standards (incorporated by reference in Rule 62-160.800, F.A.C.), contains all applicable reporting elements specified in Sections 5.5.10.3 and 5.5.10.4 of the 2003 NELAC Standards, and 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) All results that are less than the laboratory’s practical quantitation limit shall be reported using the applicable data qualifiers.

(b) Except for tests in which a method detection limit is not required, non-detected analytes shall be indicated by the method detection limit value, followed by the code “U”.

(c) For tests that do not require a method detection limit study, values below the reporting limit attributed to the test shall be reported as the reporting limit value followed by the code “U”.

(d) When the holding time for a preparation step is specified, the date of sample preparation shall be reported. The time shall also be reported if the holding time for sample preparation is equal to or less than 72 hours.

(e) Any additional information specified by the Department in contracts, orders, permits or Chapter 62 rules shall be reported.

(2) A laboratory shall issue an analytical report that is consistent with the requirements of the DOH ELCP and using applicable qualifiers as defined in Table 1: Data Qualifiers Codes. In addition, when specified by the Department in a contract, order, permit or other Title 62 rule, the following laboratory information shall be provided in reports issued to the client for Department-related work or in reports issued directly to the Department:

(a) Laboratory name, address and phone number;

(b) Project information such as client name, site name, client project number, or client project name;

(d) Date and time of sample collection;

(e) Sample matrix (e.g., groundwater, effluent, waste, soil, etc.);

(f) Sample type (e.g., environmental sample, field blank, matrix spike);

(g) Laboratory identification number for each sample fraction;

(h) Sample receipt conditions such as proper and intact custody seals, or receipt temperature;

(i) Type of chemical and/or physical sample preservative and if intact at sample receipt/analysis;

(j) Sample analysis method;

(k) Sample preparation method, if applicable;

(l) Date of sample preparation, if applicable;

(m) Time of sample preparation if the holding time specified in Rule 62-160.400, F.A.C., is less than or equal to 48 hours;

(n) Date of sample analysis;

(o) Time of sample analysis if the holding time specified in Rule 62-160.400, F.A.C., is less than or equal to 48 hours;

(p) Identification of all laboratories providing analytical results in the report and the appropriate laboratory certification numbers from the DOH ELCP (if applicable) for each laboratory;

(q) Textual comments, if applicable, that specify any samples failing to meet preservation, container or holding time as determined by laboratory at sample receipt;

(r) Textual comments, if applicable, that specify any deviations (such as failed quality control), additions to, or exclusions from, the analytical method (such as environmental conditions), and any non-standard conditions that may have affected the quality of results;

(s) Batch identifiers that unambiguously link groups of samples to a specified set of activities such as preparation, analysis, shipping, reporting, or quality control;

(t) For chemical testing:

1. Analyte name;

2. Analyte CAS registry number or NELAP parameter code, if available;

3. The analytical result for each analysis with applicable Data Qualifiers, as specified in Table 1: Data Qualifiers Codes;

a. Non-detected analytes shall be indicated by the method detection limit value, followed by the code “U”;

b. Laboratories may report a non-detected analyte whose method detection limit is two orders of magnitude below the target criterion with a value no greater than one order of magnitude below the target criteria. Such values shall be reported with a “U” qualifier.

4. Result units;

5. Sample lab filtered? (Yes or No – was the sample filtered in the laboratory?);

6. Method detection limit(s);

7. Practical quantitation limit(s);

8. Dilution factor;

9. Batch ID (unambiguous reference linking samples prepared or analyzed together);

10. Replicate sample reference (an unambiguous reference to laboratory replicate samples);

11. Matrix spike concentration level (level of analyte added to a spiked sample);

12. Matrix spike recovery (results for matrix spike/duplicate sample analysis required by methods);

13. Matrix spike duplicate recovery (results for matrix spike/duplicate sample analysis as required by the method);

14. Matrix spike precision (results for matrix spike/duplicate sample analysis as required by methods expressed as Relative Percent Difference or % Relative Standard Deviation, as defined in DEP-QA-001/01 (February 1, 2004);

15. Matrix spike recovery limits (in-house recovery limits used by the data generator to control their process);

16. Matrix spike precision limits (in-house recovery limits used by the data generator to control their process);

17. Results for laboratory replicate samples (results for duplicate/replicate sample analysis as required by the method);

18. Laboratory blank results (results for any laboratory blank analysis as required by the method and DEP-SOP-001/01 (February 1, 2004);

19. Field quality control results including trip blanks, field blanks, equipment blanks, and field replicates as required by DEP-SOP-001/01 (February 1, 2004) or the applicable contract, order, permit or Title 62 rule.

20. Surrogate spike concentration level (level of analyte added to the sample);

21. Surrogate spike recovery (if surrogate spikes are required by the method);

22. Surrogate recovery limits (if surrogates are required by the method);

23. Other sample characteristics such as percent moisture or fraction (i.e., total or dissolved);

(u) For toxicity (bioassay) testing:

1. Test type (acute or chronic);

2. Test organism(s) used;

3. Age(s) of test organism(s);

4. Test result(s);

5. Statistical method used to generate the result(s);

6. Control data (mortality/weight/reproduction, etc.) as appropriate to test type;

7. Test end points and confidence intervals;

8. Standard reference toxicant data associated with batch of test organisms;

9. Physical and chemical measures (pH, temperature, dissolved oxygen, etc.).

(v) For benthic invertebrate taxonomic identification:

1. Sorting efficiency, as percent (%);

2. Number and identity of taxa in sample;

3. Percent agreement between or among identifications performed by two or more independent taxonomists associated with period when results were generated;

4. Were all organisms verified against standard reference collection? (Yes or No);

5. Does organism range include Florida? (Yes or No).

(w) For algal taxonomic identification:

1. Percent agreement between or among identifications performed by two or more independent taxonomists associated with period when results were generated;

2. Number and identity of taxa in sample;

3. Microscope magnification;

4. Dilution factor;

5. Surface area sampled (periphyton); volume sampled (phytoplankton);

6. Number of fields counted;

7. Counting chamber dimensions.

(x) For microbiological testing:

1. Identity of test;

2. Test result with applicable data qualifiers, as specified in Table 1: Data Qualifiers Codes;

3. Test result units;

4. Results for laboratory replicate samples (results for duplicate/replicate sample analysis as required by the method) and field replicate samples, if performed;

5. Replicate sample reference (an unambiguous reference to laboratory replicate samples);

6. Field and laboratory blank results (results for any field and laboratory blank analysis as required by the method and DEP-SOP-001/01 (February 1, 2004);

7. Number of colonies in dilution water suitability test associated with samples;

8. Optimal growth in media test? (Yes or No);

(y) Any additional elements specified by the Department in contracts, orders, permits or Title 62 rules.

(3) Laboratories that are operated by a facility and whose sole function is to provide data to the facility management for compliance purposes (in-house or captive laboratories as described in 5.5.10.1 of the 2003 NELAC Standard) shall meet the requirements specified in 5.5.10.1 of the NELAC Standard.

(4)(3) If required requested by the Department in an applicable contract, order, permit or Chapter Title 62 rule, or requested by a Department program, laboratory data issued to a client(s) for Department‑related work or directly to the Department shall be provided in the Department-specified paper format or in an electronic format meeting Department consistent with requirements for importing into Department databases or for other electronic submission requirements. In addition, certain Department programs specify the submission of paper reports. Specific electronic and paper report format requirements shall be specified by the Department in the applicable contract order, permit or Title 62 rule.

(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 5.5.10.8 of the 2003 NELAC Standard.

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

(7) When data qualifiers are added through a validation or review process that is independent of the laboratory reporting process, the reason for the addition, the date of the addition, and the entity 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 (7) above.

62-160.400 Sample Preservation and Holding Times.

(1) Except as noted in subsection (2) below, or as otherwise provided for in the rules of a specific Department program, sample preservation methods, container types and holding times shall follow those requirements specified in DEP-SOP-001/01 (March 31, 2008 February 1, 2004), Section FS 1006 in FS 1000 1070, which is incorporated by reference in Rule 62-160.800, F.A.C.

(2) Sample preservation procedures, container material and maximum allowable holding times for analytes not specified in DEP-SOP-001/01 (March 31, 2008 February 1, 2004) shall follow the method-specified requirements. If no method-specified requirements exist, the best available scientific knowledge shall be used as guidance for determining the appropriate procedures for use.

Specific 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, 403.783, 403.853 FS. History– New 1-1-91, Amended 2-4-93, Formerly 17-160.400, Amended 3-24-96, 10-15-96, 4-9-02, 6-8-04,_________.

62-160.405 Electronic Signatures.

Laboratory and field documents signed with an electronic signature are acceptable as written signatures when:

(1) The integrity of the electronic signature can be assured;

(2) The signature is unique to the individual;

(3) The organization using electronic signatures has written policies for the generation and use of electronic signatures; and

(4) The organization using electronic signatures has written procedures for ensuring the security, confidentiality, integrity and auditability of each signature.

Specific Authority 668.006 FS. Law Implemented 668.006, 668.50 FS. History–New_________.

62-160.650 Field and Laboratory Audits.

(1) The Department and agencies or individuals with delegated authority from the Department shall conduct periodic audits of field and laboratory procedures and/or records to determine if approved protocols are being followed as required and to ensure data are being generated in compliance with the requirements of this chapter.

(2) An audit shall consist of one or more of the following:

(a) An on-site assessment of field sampling and/or laboratory procedures;

(b) A review, assessment and/or validation of data associated with a Department program activity;

(c) The submission of performance samples (e.g., for example, blind, split and/or performance check samples) to an organization for subsequent use in the evaluation of that organization’s technical performance associated with a specific Department project or program activity; or

(d) Other relevant information as specified in a Department contract, order, permit, or Chapter Title 62 rule.

(3) through (4) No change.

(5) Within ninety (90) days of the audit, the Department shall provide a preliminary audit report to the audited party. 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 to the audit findings. A final audit report will be provided to the audited party within ninety (90) days of the audit unless the Department provides written request for additional information. In that case, the Department shall specify a date by which the audited party will receive the final audit report in the written request for additional information. Upon receipt of the final audit report, the audited party shall have thirty (30) days thereafter to respond to the Department with a letter that addresses the corrective action and implementation schedule for any deficiency that may have been noted in the final report, and provides justification for noted deficiencies that will not be addressed or corrected.

(6) Failure to respond with a plan letter of corrective action or to additional requests by the Department for a plan of corrective action shall result in a recommendation to the affected program that the data not be used the rejection by the Department of the associated project data until such time that the noted deficiencies are corrected. Rejection of data under this subsection shall follow the procedures set forth in subsection 62-160.670(3), F.A.C., and Chapter 120, F.S.

(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 that outlines acceptance or rejection of the audited party’s plan of corrective actions, and any recommendations concerning the usability of the audited data.

Specific 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, 403.783, 403.853 FS. History– New 1-1-91, Formerly 17-160.650, Amended 3-24-96, 4-9-02, _________.

62-160.670 Data Validation by the Department.

(1) All data generated for Department activities are subject to data verification and data validation to determine if the data are suitable and usable for a specified purpose data meet program or project data quality objectives. Data shall be verified and validated based on the assessment of the following:

(a) Completeness of the Department requested data package(s) and the response of involved parties to any Department requests for additional data;

(b) Integrity of samples as determined by complete and proper sample transmittal chain of custody documentation, and records that demonstrate adherence to proper preservation, transport or other sample handling protocols, as applicable;

(d) Proper selection and use of analysis methods;

(e)(d) Sufficient Proper and sufficient use and routine evaluation of quality control measures to establish the precision, accuracy, sensitivity, selectivity, and potential bias associated with the analytical system and associated resultsand criteria;

(f) Proper instrument calibration and verification procedures;

(e) through (g) renumbered (g) through (i) No change.

(j)(h) Status of the laboratory’s certification through the DOH ELCP as provided in Chapter 64E-1, F.A.C., for any given analyte or category of analytes. Data associated with any given analyte or category of analytes generated during any period of suspension or revocation of laboratory certification as provided in Sections 403.0625(4) and (5) and 403.863, F.S., shall be subject to rejection unless certification requirements have been waived as provided in paragraph 62-160.300(5)(e), F.A.C.; and

(k)(i) Appropriateness of the collected data as related to the specific data quality objectives of the Department program activity or project for which they were collected including those data being considered for secondary use.

(2) The Department will evaluate data according to the criteria in paragraphs (a) through (k) above and determine if the data are usable.

(3) In addition to section (2) above, the Department shall also evaluate data according to the procedures outlined in the Department’s document “Department of Environmental Protection Process for Assessing Data Usability (DEP-EA-001/07),” dated March 31, 2008, which is incorporated by reference in Rule 62-160.800, F.A.C.

(4) If the audited data are secondary use data, and the Department determines that the data do not meet the data quality objectives for the secondary use, the Department will recommend that the data not be used by the program that is considering the secondary use. The recommendation not to use secondary data does not impact the usability or validity of the data for the program for which the data were originally intended.

(2) If the Department determines that the data cannot be verified or validated based on one or more of the items in paragraphs 62-160.670(1)(a) through (i), F.A.C., or the Department determines that the affected data are not useable for their intended purpose, the data shall be rejected in whole or in relevant part by the Department.

(3) If the Department determines the data should be rejected, either in whole or in part for use by its programs or for a specified project, the Department shall issue a notice of intent to reject. A copy of the notice of intent to reject shall be provided, as applicable, to the affected permittee, facility owner/operator, laboratory and any field sampling consultant, as well as to any party who has submitted a specific request to receive such notice. Any substantially affected party (e.g., respondent, permittee, consultant, company or laboratory) may request an administrative hearing as provided in Chapter 120, F.S., within 21 days of receipt of the notice.

62-160.700 Tables.

The following tables have been referenced in this chapter and are identified by this Chapter 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 data values that either meet the specified description outlined below or do not meet the quality control criteria of the laboratory:

Symbol	Meaning
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 (i.e., field gas chromatograph data, immunoassay, 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 between the laboratory method detection limit but less than and the laboratory practical quantitation limit.
J	Estimated value. A “J” value shall be accompanied by a detailed explanation to justify the reason(s) for designating the value as estimated. narrative justification for its use. Where possible, the organization shall report whether the actual value is estimated to be less than or greater than the reported value. A “J” value shall not be used as a substitute for K, L, M, T, V, or Y, however, if additional reasons exist for identifying the value as an estimate (e.g., matrix spiked failed to meet acceptance criteria), the “J” code may be added to a K, L, M, T, V, or Y. 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 a blank other than the method blank (such as calibration blank or field-generated blanks and the value of 10 times the blank value was equal to or greater than the associated sample value); or instances when the field or laboratory calibrations or calibration verifications did not meet calibration acceptance criteria. The following are some examples of narrative descriptions that may accompany a “J” code:
	No known quality control criteria exist for the component;
	The reported value failed to meet the established quality control criteria for either precision or accuracy (the specific failure must be identified);
	The sample matrix interfered with the ability to make any accurate determination;
	The data are questionable because of improper laboratory or field protocols (e.g., composite sample was collected instead of a grab sample).
	The field calibration verification did not meet calibration acceptance criteria.
K	Off-scale low. Actual value is known to be less than the value given. 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. 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	Indicates 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 the associated sample value. 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 (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.; the numeric value represents the filtration volume.
?	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
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.
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 than normal value.
!	Data deviate from historically established concentration ranges.

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 (March 31, 2008 February 1, 2004), Florida Department of Environmental Protection, Bureau of Laboratories, Environmental Assessment Section. This document is a compendium of standard operating procedures with the following major topics:

1. FA 1000: Regulatory Scope and Administrative Procedures for Use of FDEP SOPs;

2. FC 1000: Cleaning / Decontamination Procedures;

3. FD 1000: Documentation Procedures;

4. FM 1000: Field Planning and Mobilization;

5. FQ 1000: Field Quality Control Requirements;

6. FS 1000: General Sampling Procedures;

7. FS 2000: General Aqueous Sampling;

8. FS 2100: Surface Water Sampling;

9. FS 2200: Groundwater Sampling;

10. FS 2300: Drinking Water Sampling;

11. FS 2400: Wastewater Sampling;

12. FS 3000: Soil Sampling;

13. FS 4000: Sediment Sampling;

14. FS 5000: Waste Sampling;

15.FS 6000: General Biological Tissue Sampling;

16. FS 7000: General Biological Community Sampling;

17. FS 8100: Contaminated Surface Sampling;

18. FS 8200: Clean Sampling for Ultratrace Metals in Surface Waters;

19. FT 1000: General Field Testing and Measurement; and

20. FT 3000: Aquatic Habitat Characterization;

(b) Department of Environmental Protection Standard Operating Procedures for Laboratory Activities, DEP-SOP-002/01 (March 31, 2008 February 1, 2004), Florida Department of Environmental Protection, Bureau of Laboratories, Environmental Assessment Section:

1. LD 1000: Laboratory Documentation;

2. LQ 1000: Laboratory Quality Control; and

3. LT 7000: Determination of Biological Indices.

(c) New and Alternative Analytical Laboratory Methods, DEP-QA-001/01 (February 1, 2004), Florida Department of Environmental Protection, Bureau of Laboratories, Environmental Assessment Section.

(d) Department of Environmental Protection Process for Assessing Data Usability, DEP-EA-001/07, Florida Department of Environmental Protection, (March 31, 2008), Environmental Assessment Section. EPA Requirements for Quality Assurance Project Plans, EPA QA/R-5, (EPA/240/B-01/003, March 2001), United States Environmental Protection Agency.

(e) Interlaboratory Collaborative Study for Method Validation in the AOAC, Appendix D, Official Methods of Analysis of the Association of Official Analytical Chemists (AOAC), 16th edition (1995), Association of Official Analytical Chemists.

(f) Closed-System Purge-and-Trap and Extraction for Volatile Organics in Soil and Waste Samples, Method 5035, Test Methods for Evaluating Solid Waste, Physical/Chemical Methods, SW 846, Third Edition, November 1986 as amended by Update III, December 1996; United States Environmental Protection Agency.

(g) Standard Methods for the Examination of Water and Wastewater, 20th Edition (1999); American Public Health Association, American Water Works Association and Water Environment Federation. The following methods and tables are incorporated by reference:

1. Table 4500-H+:I: Preparation of pH Standard Solutions, Method 4500-H+ B, Electrometric Method;

2. Method 2510, Conductivity;

3. Method 2520, Salinity;

4. Table 8010:III: Procedure for Preparing Reconstituted Seawater, Method 8010, Introduction to Toxicity;

5. Method 4500-O C, Dissolved Oxygen, Azide Modification;

6. Method 2130, Turbidity;

7. Residual Chlorine:

a. Method 4500-CI B, Iodometric Method l

b. Method 4500-CI C, Iodometric Method ll

c. Method 4500-CI D, Amperometric Titration Method

d. Method 4500-CI F, DPD Ferrous Titrimetric Method

e. Method 4500-CI E, Low-Level Amperometric Titration Method

f. Method 4500-CI G, DPD Colorimetric Method

(f) EPA Requirements for Quality Assurance Project Plans, EPA QA/R-5, EPA/240/B-01/003, March 2001, United States Environmental Protection Agency.

(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, Volume 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, Volume 72, No. 57, Monday March 26, 2007 pp. 14220 – 14233. Methods for Chemical Analysis of Water and Wastes, Revised March 1983, United States Environmental Protection Agency. The following methods and tables are incorporated by reference:

1. Method 120.1, Conductance, Specific,

2. Method 330.1 Chlorine, Total Residual, Titrimetric, Amperometric,

3. Method 330.2 Chlorine, Total Residual, Titrimetric, Back, Iodometric,

4. Method 330.3 Chlorine, Total Residual, Titrimetric, Iodometric,

5. Method 330.4 Chlorine, Total Residual, Titrimetric, DPD-FAS,

6. Method 330.5, Chlorine, Total Residual, Spectrophotometric, DPD.

(i) Policy and Program Requirements for the Mandatory Agency-Wide Quality System, EPA Order 5360.1 A2, May 5, 2000, United States Environmental Protection Agency.

(j) U.S. Environmental Protection Agency Office of Research and Development, ICR Microbial Laboratory Manual, EPA/600/ R-95/178, Section VII, Part 9, April 1996.

(i)(k) U.S. Environmental Protection Agency Office of Water, Method 1623: Cryptosporidium and Giardia in Water by Filtration/IMS/FA, EPA-821-R-99-006, April 1999.

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

(k) Glossary of the 2001 NELAC Standards, EPA/600/R-01/100, May 2001, United States Environmental Protection Agency.

(2) No change.

NAME OF PERSON ORIGINATING PROPOSED RULE: Daryll Joyner, Chief, Bureau of Standards and Special Projects

NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Michael W. Sole, Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 12, 2008

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: July 6, 2007

Document Information

Comments Open:: 6/27/2008
Summary:: Changes in the rule include updating the reference dates of DEP-SOP-001/01 and DEP-SOP-002/01; clarifying the applicability of the rule to include all organizations that are a part of the sample collection/laboratory analysis process; identifying new and revised standard operating procedures for biological assessments in DEP-SOP-001/01 and DEP-SOP-002/01 (Qualitative Periphyton Sampling , Rapid Periphyton Survey, Lake Vegetation Index sampling and calculation, Stream Condition Index calculation ...
Purpose:: The purpose of this rulemaking is to update the Department’s Standard Operating Procedures (SOPs) for Field Activities (DEP-SOP-001/01) and Laboratory Activities (DEP-SOP-002/01). The majority of these updates are intended to clarify and/or correct procedures in the original documents, and should have minimal effect on a majority of laboratory or field operations. There are, however, a limited number of new Standard Operating Procedures for conducting and interpreting biological assessments, ...
Rulemaking Authority:: 403.061, 403.0623, 668.006 FS.
Law:: 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, 403.783, 403.853, 668.006, 668.50 FS.
Contact:: Amanda Cantrell, Florida Department of Environmental Protection, 2600 Blair Stone Road, MS 6511, Tallahassee, Florida 32399-2400, (850)245-8065, amanda.cantrell@dep.state.fl.us.
Related Rules: (15): 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; More ...