Fla. Admin. Code Ann. R. 62-160.600 - Research Field and Laboratory Procedures
(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
Rule
62-160.300,
F.A.C. However, the Department project manager may waive the requirement for
laboratory certification as provided in paragraph
62-160.300(5)(e),
F.A.C.
(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.
Notes
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.
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