Florida Regulations 62-160.600: Research Field and Laboratory Procedures
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(1) Research field sampling and laboratory procedures involve one or more of the following:
(a) Evaluation, development or use of new, innovative technologies not yet approved by the Department;
(b) Evaluation, development or use of innovative field sampling or analytical laboratory methods not yet approved by the Department;
(c) Evaluation of new methodology or technology to be used in lieu of a Department-approved method described in subsection 62-160.320(1), F.A.C.; and,
(d) Other projects not included in the above areas but designated as research by the relevant Department project or contract manager.
(2) If a research field sampling or laboratory method is being developed for subsequent use in compliance or other regulatory activities, the method shall be reviewed and approved according to the requirements provided in Rules 62-160.220 and 62-160.330, F.A.C.
(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) Project purpose and intended end use of the data, such as specific hypotheses and topics to be investigated;
(b) Brief historical overview or literature searches;
(c) Statement of anticipated results or effects of the research project;
(d) Description of work to be conducted, including the types of analyses to be performed to monitor the effectiveness of the research;
(e) The information and records to be included in the data report package and the reporting format for hard copy and electronic reports, such as all documentation to be delivered to the Department as work product as required by a grant or contract. Minimum requirements for record keeping shall follow those specified in Rules 62-160.240 and 62-160.340, F.A.C., as applicable;
(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 Fl. Admin. Code R. 62-160.300 However, the Department project manager may waive the requirement for laboratory certification as provided in Fl. Admin. Code R. 62-160.300(5)(e)
(g) All aspects of data generation and acquisition to ensure appropriate methods for sampling, sample preservation, sample storage conditions and maximum holding (storage) time limits, measurement and analysis, data collection or generation, data handling and data storage procedures, and quality assurance and quality control activities are employed and documented;
(h) The experimental data generation or data collection design for the project, such as:
1. Types and numbers of samples required;
2. Design of the sampling network;
3. Sample matrices, sampling locations, and sampling frequencies or schedules;
4. Field or laboratory sample testing or analyses frequencies or schedules;
5. Topics to be investigated by the research, such as analytes, organisms, and populations of interest;
6. Rationale for the experimental or research project design;
7. Procedures for collecting samples, such as sample handling, preservation and custody in the field and laboratory, sample transport, sampling equipment specifications, and equipment decontamination procedures;
8. Sample preparation (if applicable) and field or laboratory testing and analytical methods used;
9. Quality control activities needed for sampling and analysis, such as all quality control measurements, control (acceptance) criteria, and procedures for the assessment of the quality control results; and, quality control activities for the field and the laboratory, such as the use of blanks, duplicates, replicates, matrix spikes, laboratory control samples and surrogates;
10. Quality assurance activities that occur after the data collection or generation phase of the project, such as data verification validation, and field and laboratory audits;
11. Criteria to be used to objectively and consistently review, verify and validate project data, including the chain of custody for data throughout the life of the project or task;
12. Proposed methods to analyze the data to evaluate the experimental or research design and determine possible anomalies or departures from assumptions established in the planning phase of data collection that may affect attainment of the research objectives;
13. Statistical and/or other procedures and criteria that will be used to evaluate the experimental data produced by the research to test hypotheses and evaluate endpoints, conclusions or other topics for the research project objectives; and,
14. Any additional elements specifically required by the Department project manager.
(4) The Department shall conduct a technical review of the project work plan prior to the project’s initiation in order to assess its technical and scientific merit and appropriateness.
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 17-160.600, Amended 3-24-96, 10-15-96, 4-9-02, 7-30-14, 4-16-18.
Terms Used In Florida Regulations 62-160.600
- Contract: A legal written agreement that becomes binding when signed.
(b) Evaluation, development or use of innovative field sampling or analytical laboratory methods not yet approved by the Department;
(c) Evaluation of new methodology or technology to be used in lieu of a Department-approved method described in subsection 62-160.320(1), F.A.C.; and,
(d) Other projects not included in the above areas but designated as research by the relevant Department project or contract manager.
(2) If a research field sampling or laboratory method is being developed for subsequent use in compliance or other regulatory activities, the method shall be reviewed and approved according to the requirements provided in Rules 62-160.220 and 62-160.330, F.A.C.
(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) Project purpose and intended end use of the data, such as specific hypotheses and topics to be investigated;
(b) Brief historical overview or literature searches;
(c) Statement of anticipated results or effects of the research project;
(d) Description of work to be conducted, including the types of analyses to be performed to monitor the effectiveness of the research;
(e) The information and records to be included in the data report package and the reporting format for hard copy and electronic reports, such as all documentation to be delivered to the Department as work product as required by a grant or contract. Minimum requirements for record keeping shall follow those specified in Rules 62-160.240 and 62-160.340, F.A.C., as applicable;
(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 Fl. Admin. Code R. 62-160.300 However, the Department project manager may waive the requirement for laboratory certification as provided in Fl. Admin. Code R. 62-160.300(5)(e)
(g) All aspects of data generation and acquisition to ensure appropriate methods for sampling, sample preservation, sample storage conditions and maximum holding (storage) time limits, measurement and analysis, data collection or generation, data handling and data storage procedures, and quality assurance and quality control activities are employed and documented;
(h) The experimental data generation or data collection design for the project, such as:
1. Types and numbers of samples required;
2. Design of the sampling network;
3. Sample matrices, sampling locations, and sampling frequencies or schedules;
4. Field or laboratory sample testing or analyses frequencies or schedules;
5. Topics to be investigated by the research, such as analytes, organisms, and populations of interest;
6. Rationale for the experimental or research project design;
7. Procedures for collecting samples, such as sample handling, preservation and custody in the field and laboratory, sample transport, sampling equipment specifications, and equipment decontamination procedures;
8. Sample preparation (if applicable) and field or laboratory testing and analytical methods used;
9. Quality control activities needed for sampling and analysis, such as all quality control measurements, control (acceptance) criteria, and procedures for the assessment of the quality control results; and, quality control activities for the field and the laboratory, such as the use of blanks, duplicates, replicates, matrix spikes, laboratory control samples and surrogates;
10. Quality assurance activities that occur after the data collection or generation phase of the project, such as data verification validation, and field and laboratory audits;
11. Criteria to be used to objectively and consistently review, verify and validate project data, including the chain of custody for data throughout the life of the project or task;
12. Proposed methods to analyze the data to evaluate the experimental or research design and determine possible anomalies or departures from assumptions established in the planning phase of data collection that may affect attainment of the research objectives;
13. Statistical and/or other procedures and criteria that will be used to evaluate the experimental data produced by the research to test hypotheses and evaluate endpoints, conclusions or other topics for the research project objectives; and,
14. Any additional elements specifically required by the Department project manager.
(4) The Department shall conduct a technical review of the project work plan prior to the project’s initiation in order to assess its technical and scientific merit and appropriateness.
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 17-160.600, Amended 3-24-96, 10-15-96, 4-9-02, 7-30-14, 4-16-18.