Purpose, Scope and Applicability, Definitions and Standards, Approved Field Procedures, Approval of New and Alternative Field Procedures, Record Keeping and Reporting Requirements for Field Procedures, Laboratory Certification, Approved Laboratory ...
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 ReferenceOGC NO.: 07-1024
NOTICE OF CHANGE
Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 34, No. 26, June 27, 2008 issue of the Florida Administrative Weekly.
62-160.110 Purpose, Scope and Applicability.
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 (33) No change.
(34) “Statewide method” is a field procedure or analytical laboratory method that is validated for the collection or testing of environmental samples from similar sites or waste streams within the state of Florida by multiple field sampling organizations or laboratories, as applicable. The process for the validation of a statewide method is outlined in Sections FA 2100 and FA 2200 of FA 1000 (Regulatory Scope and Administrative Procedures for Use of FDEP SOPs) in DEP-SOP-001/01 (March 31, 2008), and “New and Alternative Analytical Laboratory Methods”, DEP-QA-001/01 (February 1, 2004)” which are incorporated by reference in Rule 62-160.800, F.A.C.
(35) 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 17-160.120, Amended 3-24-96, 4-9-02, 6-8-04,________.
62-160.210 Approved Field Procedures.
(1) through (2) 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 17-160.210, Amended 3-24-96, 10-15-96, 4-9-02, 6-8-04,_________.
62-160.220 Approval of New and Alternative Field Procedures.
(1) through (6) No change.
(7) The approval or disapproval of any submitted new or alternative field procedure shall be noticed as follows:
(a) For procedures that are submitted for site-specific use, the Department shall issue an order of approval or disapproval of the new or alternative field procedure to the person who submitted the procedure (including the Department). Any additional administrative or scientific information pertinent to the approval or disapproval of the procedure shall be included or incorporated by reference in the order. On the date of its issuance, the order and the new or alternative field procedure shall be submitted for posting on the Department’s Internet site, and all persons enrolled to receive the Department’s Quality of Science eNewsletter shall be notified of the approval or disapproval of the submitted procedure via the designated listserve.
(b) For procedures that are submitted for statewide use, the Department shall issue an order to the person who submitted the procedure (including the Department). Any additional administrative or scientific information pertinent to the approval or disapproval of the procedure shall be included or incorporated by reference in the order. A notice of the order approving or disapproving the procedure shall be published in the Florida Administrative Weekly. On the date of its issuance, the order and the new or alternative field procedure shall be submitted for posting on the Department’s Internet site, and all persons enrolled to receive the Department’s Quality of Science eNewsletter shall be notified of the approval or disapproval of the submitted procedure via the designated listserve.
(c) Any person substantially affected by the approval or disapproval of the new or alternative field procedure may request an administrative hearing as provided in Chapter 120, F.S., within 21 days of the date of the order for site-specific use and within 21 days of the date of publication of the order in the Florida Administrative Weekly for statewide use.
(8)(7) Any new or alternative field procedure approved for statewide use shall be incorporated into updates of the Department’s field sampling procedures (DEP-SOP-001/01). New or alternative field procedures approved for limited use shall not be incorporated into DEP-SOP-001/01.
(9)(8) A field procedure approved by the Department shall be removed from approval if new technical, scientific or regulatory information justifies its removal. The Department shall use the best scientific and technical information, methods and data in its possession in making the determination to remove a procedure from approval.
(a) For a new or alternative field procedure that was approved for site-specific use, the Department shall issue an order of rescission of approval of the new or alternative field procedure to the person who submitted the procedure (including the Department). Any additional administrative or scientific information pertinent to the rescission of approval of the procedure shall be included or incorporated by reference in the order. On the date of its issuance, the order shall be submitted for posting on the Department’s Internet site, and all persons enrolled to receive the Department’s Quality of Science eNewsletter shall be notified of the rescission of approval of the procedure via the designated listserve. Any person substantially affected by the rescission of approval of the new or alternative field procedure may request an administrative hearing as provided in Chapter 120, F.S., within 21 days of the date of the order. If the affected procedure has been approved for statewide use and incorporated into the Department’s field sampling procedures (DEP-SOP-001/01), the Department shall issue a notice of intent to revise the SOPs to remove the affected procedure. This notice shall include the technical justification for the removal of the procedure and shall be published in the Florida Administrative Weekly and on the Department’s Internet site. Any substantially affected party may request an administrative hearing as provided in Chapter 120, F.S., within 21 days of receipt of the notice.
(b) For a new or alternative field procedure that was approved for statewide use, the Department shall issue an order of rescission of approval of the new or alternative field procedure to the person who submitted the procedure (including the Department). Any additional administrative or scientific information pertinent to the rescission of approval of the procedure shall be included or incorporated by reference in the order. A notice of the order rescinding approval of the procedure shall be published in the Florida Administrative Weekly. On the date of its issuance, the order shall be submitted for posting on the Department’s Internet site, and all persons enrolled to receive the Department’s Quality of Science eNewsletter shall be notified of the rescission of approval of the procedure via the designated listserve. Any person substantially affected by the rescission of approval of the new or alternative field procedure may request an administrative hearing as provided in Chapter 120, F.S., within 21 days of the date of publication of the order in the Florida Administrative Weekly. If the affected procedure has been approved for limited use, the Department shall issue a notice of intent to remove the procedure from approval. This notice shall include the technical justification for the removal of the procedure and shall be addressed to the party (e.g., permittee, consultant, company) initially requesting approval for the field procedure. Any substantially affected party may request an administrative hearing as provided in Chapter 120, F.S., within 21 days of receipt of the notice.
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) through (3) 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 4-9-02, Amended 6-8-04,_________.
62-160.300 Laboratory Certification.
(1) through (6) 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, 403.863 FS. History–New 1-1-91, Amended 2-4-93, 2-27-94, Formerly 17-160.300, Amended 3-24-96, 4-9-02, 6-8-04,_________.
62‑160.320 Approved Laboratory Methods.
(1) through (3) 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 4-9-02, Amended________.
62‑160.330 Approval of New and Alternative Laboratory Methods.
(1) through (5) No change.
(6) The approval or disapproval of any submitted new or alternative method shall be noticed as follows:
(a) For methods that are submitted for limited use, the Department shall issue an order of approval or disapproval of the new or alternative method to the person who submitted the method (including the Department). Any additional administrative or scientific information pertinent to the approval or disapproval of the method shall be included or incorporated by reference in the order. On the date of its issuance, the order and the new or alternative method shall be submitted for posting on the Department’s Internet site, and all persons enrolled to receive the Department’s Quality of Science eNewsletter shall be notified of the approval or disapproval of the submitted method via the designated listserve.
(b) For methods that are submitted for statewide use, the Department shall issue an order to the person who submitted the method (including the Department). Any additional administrative or scientific information pertinent to the approval or disapproval of the method shall be included or incorporated by reference in the order. A notice of the order approving or disapproving the method shall be published in the Florida Administrative Weekly. On the date of its issuance, the order and the new or alternative method shall be submitted for posting on the Department’s Internet site, and all persons enrolled to receive the Department’s Quality of Science eNewsletter shall be notified of the approval or disapproval of the submitted method via the designated listserve.
(c) Any substantially affected party may request an administrative hearing as provided in Chapter 120, F.S., within 21 days of the date of the order for limited use or within 21 days of the date publication of the order in the Florida Administrative Weekly for statewide use.
(7)(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 and 136.6 (2008). Applicants shall submit the application to the Department, which shall forward the application to the United States Environmental Protection Agency Administrator of Region 4 for review and approval. The determination for approval or rejection shall be made by the United States Environmental Protection Agency.
(8)(7) No change.
(9) Except for methods promulgated by the United States Environmental Protection Agency in the Federal Register, a new or alternative laboratory method approved by the Department shall be removed from approval if new technical, scientific or regulatory information justifies its removal. The Department shall use the best scientific and technical information, methods and data in its possession in making the determination to remove a laboratory method from approval.
(a) For a new or alternative laboratory method that was approved for limited use, the Department shall issue an order of rescission of approval of the new or alternative laboratory method to the person who submitted the method (including the Department). Any additional administrative or scientific information pertinent to the rescission of approval of the method shall be included or incorporated by reference in the order. On the date of its issuance, the order shall be submitted for posting on the Department’s Internet site, and all persons enrolled to receive the Department’s Quality of Science eNewsletter shall be notified of the rescission of approval of the method via the designated listserve. Any person substantially affected by the rescission of approval of the new or alternative laboratory method may request an administrative hearing as provided in Chapter 120, F.S., within 21 days of the date of the order.
(b) For a new or alternative laboratory method that was approved for statewide use, the Department shall issue an order of rescission of approval of the new or alternative laboratory method to the person who submitted the method (including the Department). Any additional administrative or scientific information pertinent to the rescission of approval of the method shall be included or incorporated by reference in the order. A notice of the order rescinding approval of the method shall be published in the Florida Administrative Weekly. On the date of its issuance, the order shall be submitted for posting on the Department’s Internet site, and all persons enrolled to receive the Department’s Quality of Science eNewsletter shall be notified of the rescission of approval of the method via the designated listserve. Any person substantially affected by the rescission of approval of the new or alternative laboratory method may request an administrative hearing as provided in Chapter 120, F.S., within 21 days of the date of publication of the order in the Florida Administrative Weekly.
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 4-9-02, Amended 6-8-04,_________.
62‑160.340 Record Keeping and Reporting Requirements for Laboratory Procedures.
(1) through (7) 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 4-9-02, Amended 6-8-04,_________.
62-160.400 Sample Preservation and Holding Times.
(1) No change.
(2) Sample preservation procedures, container material and maximum allowable holding times for analytes not specified in DEP-SOP-001/01 (March 31, 2008) shall follow the preservation, container and holding time requirements specified in the selected analytical method 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.
(1) through (4) No change.
Specific Authority 403.0623, 668.006 FS. Law Implemented 668.006, 668.50 FS. History–New_________.
62-160.650 Field and Laboratory Audits.
(1) through (7) 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, Formerly 17-160.650, Amended 3-24-96, 4-9-02, _________.
62-160.670 Data Validation by the Department.
(1) through (3) No change.
(4) If the audited data were originally generated for a specific purpose but are being considered for a secondary use for another purpose (secondary use) are secondary use data, and the Department determines from the evaluation process, as described in subsections 62-160.670(2) and 62-160.670(3), F.A.C., above, 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.
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 17-160.670, Amended 3-24-96, 4-9-02,_________.
62-160.700 Tables.
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 17-160.700, Amended 3-24-96, 4-9-02, 6-8-04,________.
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), Florida Department of Environmental Protection, Standards and Environmental Assessment Section.
(b) Department of Environmental Protection Standard Operating Procedures for Laboratory Activities, DEP-SOP-002/01 (March 31, 2008), Florida Department of Environmental Protection, Standards and Environmental Assessment Section.:
(c) New and Alternative Analytical Laboratory Methods, DEP-QA-001/01 (February 1, 2004), Florida Department of Environmental Protection, Standards and 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), Standards and Environmental Assessment Section.
(e) through (h) No change.
(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.
(i) 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) through (k) No change.
(2) 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 4-9-02, Amended 6-8-04,_________.
