Fla. Admin. Code Ann. R. 62-160.330 - Approval of Alternative and Modified Laboratory Methods
(1) Any person may apply for use of a
laboratory method in place of the approved methods described in subsection
62-160.320(1),
F.A.C. Any laboratory method proposed for use in place of those described in
subsection
62-160.320(1),
F.A.C., or in place of laboratory methods specified or required in other rules
of the Department must be approved by the Department prior to use, as further
required below. Laboratory methods that have been previously approved for use
in a Department rule, contract, order, or permit shall remain approved while
such documents remain in effect. In such cases, the documentation that approved
the use of the method must be retained for at least five years after the last
use of the method for the specific samples analyzed by the approved method.
Laboratory methods approved by the Department to meet established data quality
objectives according to subsection
62-160.320(1),
F.A.C., and alternative or modified laboratory methods previously approved by
the Department shall remain approved, except as provided in subsection
62-160.330(9), F.A.C.
(2)
Laboratory methods used in place of those specified or required in Department
rules, contracts (including purchase requisitions), orders, or permits are
designated by the Department as alternative laboratory methods. Alternative
laboratory methods that support a Department rule, contract, order, or permit
must be approved by the Department prior to use. Alternative laboratory methods
cannot be approved for the following:
(a) Any
method that the United States Environmental Protection Agency has designated
for analysis of a "method-defined analyte;"
(b) The following methods from DEP-SOP-002/01
(January 2017), which is incorporated by reference in subparagraph
62-160.800(1)(b)
3., F.A.C., including all subparts of the methods cited:
1. Part LT 7300 of LT 7000, Lake Condition
Index (LCI) Determination; and,
2.
Part LT 7600 of LT 7000, Determination of Wetland Condition Indices;
and,
(c) The laboratory
methods described in the DEP SOPs BRN 1000 (January 2017), SCI 1000 (January
2017), and LVI 1000 (January 2017), including all applicable parts and subparts
of the methods cited, which are contained in DEP-SOP-003/11, which is
incorporated by reference in paragraph
62-160.800(1)(c),
F.A.C.
(3) The
Department defines a laboratory method modification as any change to a
published analytical laboratory method that alters the scope and applicability,
specifications, procedures, steps, performance criteria, or any other
requirements described in the published method, as applicable to the analytes
and matrices for which the method was originally published. A published method
is any analytical laboratory method specified, recognized or approved by the
Department according to subsection
62-160.320(1),
F.A.C., or other procedures in scientific journals or other technical
literature.
(a) A modified method must
satisfy the data quality objectives established by the Department project,
permit, rule, contract, order, or data use for which the modifed method will be
performed; and the laboratory shall retain all data that demonstrate that the
modification meets the Department's data quality objectives. Additionally,
validation of the modified method shall demonstrate that the modified method
produces equivalent or superior analytical performance, as compared to the
unmodified method, when applicable to the analyte and matrix for which the
modifed method will be used. These demonstration records shall be retained for
at least five years after the last use of the modification for the specific
laboratory sample(s) analyzed by the modified method. The Department's approval
of the modified method shall be limited to the specific method scope and
modifications validated by the laboratory.
(b) Upon review of any request to use a
modified method, the Department shall determine whether the proposed modified
method constitutes an alternative method according to subsection 62-160.330(2),
F.A.C. All proposals to use modified methods as alternative methods shall
include the submittal of method validation documentation to the Department
according to the requirements in subsection 62-160.330(4), F.A.C.
(c) Methods listed in paragraphs
62-160.330(2)(a) - 62-160.330(2)(c), F.A.C., shall not be modified.
(d) When method modifications are
specifically allowed as indicated in subparagraphs 62-160.330(3)(d) 1. -
62-160.330(3)(d) 3., F.A.C., below, submittal of method validation
documentation to the Department prior to use is not required, and such
modifications are pre-approved by the Department. When laboratory certification
is required according to Rule
62-160.300,
F.A.C., applicable requirements for method validation, and applicable initial
and ongoing demonstrations of capability for use of the modified method shall
be performed as required in the applicable testing module of the 2016 TNI
Standard, which is incorporated by reference in paragraph
62-160.800(3)(b),
F.A.C. In addition, all applicable requirements for the use of non-standard
methods, such as validation of methods, as discussed in Module 2 of the 2016
TNI Standard, shall be met for the use of any modified methods requiring
laboratory certification.
1. Modifications
specifically allowed according to descriptions or discussions in the original,
unmodified method are pre-approved by the Department. Any constraints or limits
to modifications specified in the original method and any required performance
criteria for allowed modifications specified in the method shall apply to all
pre-approved modifications.
2.
Allowable modifications described by the Environmental Protection Agency (EPA)
at 40 CFR, Part 136.6, which is incorporated by reference in subsection
62-160.800(9),
F.A.C., apply to the methods listed at 40 CFR, Part 136.3, which is
incorporated by reference in subsection
62-160.800(6),
F.A.C., and are pre-approved by the Department. In accordance with 40 CFR, Part
136.6, a facility shall notify the Department's permit processor of any
specific use of a modified method for analysis of compliance samples associated
with a permitted facility.
a. The Department
shall consider all interpretations of 40 CFR Part 136.6 as published by the EPA
on its webpages or in applicable EPA memoranda when responding to requests from
any person for assistance in clarifying whether a modification to a method
listed at 40 CFR, Part 136.3 is allowed. When such a determination is uncertain
or controversial, the Department shall refer the request to the EPA Region 4
Regional Administrator for determination. However, this determination shall not
supersede any requirements in Department rules, contracts, orders, or permits
to use specific methods.
b.
Allowable modifications described in 40 CFR, Part 136.6 shall apply to other
approved methods that are not listed in 40 CFR, Part 136.3, which is
incorporated by reference in subsection
62-160.800(6),
F.A.C., and shall be considered for pre-approval by the Department upon
request. The Department shall consider the applicability of allowable
modifications as described in 40 CFR, Part 136.6, which is incorporated by
reference in subsection
62-160.800(9),
F.A.C., to other methods according to sub-subparagraph 62-160.330(3)(d) 2.a.,
F.A.C., above. If the Department determines that the requested modifications
meet Department data quality objectives according to 40 CFR Part 136.6
requirements for the specific use(s) of the method requested and are
pre-approved, then the submission of method validation documentation to the
Department is not required.
3. The Department has determined that methods
published by the Environmental Protection Agency (EPA) in the collection titled
"Test Methods for Evaluating Solid Waste, Physical/Chemical Methods (SW-846)"
may be modified to achieve Department data quality objectives when such
modifications are made according to the information and requirements for
implementing flexibility in the use of SW-846 methods, alternative methods, or
modified methods, as discussed in Chapter Two, Section 2.1, in SW-846, which is
incorporated by reference in subsection
62-160.800(11),
F.A.C. However, this determination shall not supersede any requirements in
Department rules, contracts, orders, or permits to use specific methods.
a. Allowable modifications as discussed in
Chapter Two, Section 2.1, in SW-846, shall apply to other approved methods that
are not included in the SW-846 collection, and shall be considered for
pre-approval by the Department upon request. The Department shall consider the
applicability of allowable modifications to other methods according to the
information and requirements for implementing flexibility in the use of
alternative or modified methods, as discussed in Chapter Two, Section 2.1 of
SW-846. If the Department determines that the requested modifications meet
Department data quality objectives according to the requirements in Chapter
Two, Section 2.1 of SW-846 for the specific use(s) of the method requested and
are pre-approved, then the submission of method validation documentation to the
Department is not required.
b. The
provisions for use of modified methods in sub-subparagraph 62-160.330(3)(d)
3.a., F.A.C., above, shall not supersede requirements in subparagraph
62-160.330(3)(d) 2., F.A.C., above.
(4) Validation documentation shall be
submitted to the Department for all proposed alternative methods and for all
proposed modified methods not pre-approved by the Department.
(a) Validation information must demonstrate
that the alternative or modified method produces equivalent or superior
analytical performance in meeting the data quality objectives established for
the Department project or specified data use, as compared to the original,
unmodified method or to the method for which it is proposed as an
alternative.
(b) When validation
documentation must be submitted to the Department, alternative laboratory
methods and modifications to published laboratory methods shall be demonstrated
as appropriate for use according to the requirements in DEP-QA-001/01, which is
incorporated by reference in subsection
62-160.800(5),
F.A.C. Alternative and modified methods shall be evaluated according to
criteria for demonstrations of initial and ongoing performance as required by
the original unmodified method or published alternative method. When laboratory
certification is required according to Rule
62-160.300,
F.A.C., applicable requirements for method validation and applicable initial
and ongoing demonstrations of capability shall be performed as required in the
applicable testing module of the 2016 TNI Standard, which is incorporated by
reference in paragraph
62-160.800(3)(b),
F.A.C. In addition, all applicable requirements for the use of non-standard
methods, such as validation of methods, as discussed in Module 2 of the 2016
TNI Standard, shall be met for the use of any alternative or modified methods
requiring laboratory certification.
(5) When evaluating or approving a proposed
alternative or modified laboratory method, the Department shall consider the
following factors and requirements for review of the proposed method, in
addition to those factors and requirements described in DEP-QA-001/01:
(a) Whether procedural steps, use of
equipment, use of reagents, use of technology, or other elements of the
laboratory method that are proposed are different than those required in the
approved laboratory method, as described in subsection
62-160.320(1),
F.A.C;
(b) Whether the use of the
alternative or modified laboratory method generates data that meet data quality
objectives established by the Department for the data;
(c) Whether the alternative or modified
laboratory method is demonstrated to be equivalent to or exceeds the
performance of the approved laboratory method that the proposed method or
modification is intended to replace;
(d) Whether the Department cannot grant
approval of the alternative or modifed method, because use of the proposed
method will produce data that are unusable by the Department for a specified
purpose, or, if the data will not be comparable to, or are otherwise
incompatible for use with existing data generated by other approved laboratory
methods, or, if the data would be invalid according to any applicable
requirements described in Rule
62-160.670,
F.A.C., below; and,
(e) Whether the
laboratory methods were developed by consensus or standardization
organizations, such as AOAC International, ASTM International, the United
States Environmental Protection Agency, or the United States Geological Survey,
or developed by manufacturers or vendors using collaborative interlaboratory
studies.
(6) The
submitted method validation documentation for an alternative laboratory method
or modification of a published method shall be evaluated based on its intended
use, and designated as either limited-use or statewide-use, if approved:
(a) For limited-use methods, the Department
shall limit the approval of the alternative or modified laboratory method
solely for use by the person or organization submitting the request, based on
the information and data provided to the Department in support of the request
for proposed method approval. A limited-use method is validated by a single
laboratory and shall only be used by that laboratory at that location or
branch. If the submitter is different than the laboratory that performed the
method validation, then the approval for limited use shall only apply to the
performing laboratory. Typically, the limited-use method is intended only for
testing environmental samples from a particular site, waste stream, facility
location, or sample matrix (such as effluent, surface water, groundwater,
drinking water, or soil). However, the Department shall approve the proposed
limited-use method for any scope that is proposed with the request for approval
if the scope of use has been validated by the supporting information submitted
with the request, according to all applicable requirements of this rule (Rule
62-160.330, F.A.C.).
(b) For
statewide-use methods, the Department shall evaluate and approve the
alternative or modified laboratory method for use by laboratories based on the
information and data provided to the Department in support of the request for
the alternative or modified method approval. Each application for statewide use
will be considered on a case-by-case basis by the Department. Approval for
statewide use does not guarantee applicability of the procedure for all
potential uses. The Department shall require the design of a collaborative
study conducted by multiple independent laboratories to investigate the
efficacy and robustness of the proposed statewide-use alternative or modified
method for specified site or environmental conditions, sample types, sample
matrices, waste streams, analytes, or other specifications applicable to the
scope of approval requested, according to the following:
1. An inter-laboratory collaborative study
following the specifications in Appendix D, Official Methods of Analysis of the
AOAC INTERNATIONAL, 19th edition (2012), which is incorporated by reference in
subsection
62-160.800(12),
F.A.C., or
2. Alternatively, an
inter-laboratory collaborative study that is developed and validated based on
procedures published by a nationally recognized, consensus-based standards
organization (for example, ASTM International).
3. Further description and specifications for
these studies are provided in DEP-QA-001/01, which is incorporated by reference
in subsection
62-160.800(5),
F.A.C.
(7)
Research methods shall be submitted for review and approval according to the
requirements provided in Rule
62-160.600,
F.A.C. If a method is initially developed for research purposes but will
subsequently be used for compliance or other regulatory activities, the method
shall be submitted for review and approval according to requirements of Rule
62-160.330, F.A.C.
(8) The approval
or disapproval of any submitted alternative or modified laboratory method shall
be noticed as follows:
(a) For limited-use
methods, the Department shall issue an order of approval or disapproval of the
alternative or modified laboratory method to the person who submitted the
method. 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. The order and the alternative or modified laboratory
method shall also be posted on the Department's website and provided to all
persons enrolled to receive the Department's Quality of Science electronic
newsletter.
(b) For statewide-use
methods, the Department shall issue an order of approval or disapproval of the
alternative or modified laboratory method to the person who submitted the
method. 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 Register. For
informational purposes only, the order and the alternative or modified
laboratory method shall also be posted on the Department's website and provided
to all persons enrolled to receive the Department's Quality of Science
electronic newsletter.
(c) Any
person substantially affected by the approval or disapproval of a limited-use
method may request an administrative hearing as provided in Chapter 120, F.S.
Any person substantially affected by the approval or disapproval of a
statewide-use method may request an administrative hearing as provided in
Chapter 120. F.S., within 21 days of publishing the notice in the Florida
Administrative Register, or within 21 days of receipt of the written notice,
whichever occurs first.
(9) For requests for the approval of proposed
alternative or modified laboratory methods, applicants who are analyzing
discharges regulated under the National Pollutant Discharge Elimination System
(NPDES) permit program shall comply with applicable regulations in 40 CFR Part
136 sections 136.4, 136.5 and 136.6 , which are incorporated by reference in
subsections
62-160.800(7)
-(9), F.A.C., respectively. If requested by the applicant, the Department shall
assist the applicant in determining whether an application for approval is
required for modifications to methods listed at 40 CFR, Part 136.3, according
to sub-subparagraph 62-160.330(3)(d) 2.a., F.A.C.
(10) For requests for the approval of
proposed alternative or modified laboratory methods, applicants who are
analyzing compliance samples under the Safe Drinking Water Act shall comply
with the applicable provisions in 40 CFR Part 141, section 141.27, which is
incorporated by reference in subsection
62-160.800(10),
F.A.C., and Rule
62-550.550,
F.A.C.
(11) Except for methods
promulgated by the United States Environmental Protection Agency in the Federal
Register, approval of a laboratory method shall be revoked by the Department if
new technical, scientific or regulatory information justifies its revocation.
The Department shall use the best scientific and technical information, methods
and data in its possession in making the determination to revoke an approved
laboratory method.
(a) For a laboratory method
that was approved for limited use, the Department shall issue an order revoking
approval of the laboratory method to the person who submitted the method. Any
additional administrative or scientific information pertinent to the revocation
of approval of the method shall be included or incorporated by reference in the
order. The order shall be posted on the Department's website and provided to
all persons enrolled to receive the Department's Quality of Science electronic
newsletter. Any person substantially affected by the revocation of approval of
the limited-use laboratory method may request an administrative hearing as
provided in Chapter 120, F.S.
(b)
For a laboratory method that was approved for statewide use, the Department
shall issue an order of revoking approval of the laboratory method to the
person who submitted the method. Any additional administrative or scientific
information pertinent to the revocation of approval of the method shall be
included or incorporated by reference in the order. A notice of the order
revoking approval of the method shall be published in the Florida
Administrative Register. For informational purposes only, the order shall also
be posted on the Department's website and provided to all persons enrolled to
receive the Department's Quality of Science electronic newsletter. Any person
substantially affected by the revocation of approval of the statewide-use
laboratory method may request an administrative hearing as provided in Chapter
120, F.S., within 21 days of publishing the notice in the Florida
Administrative Register, or within 21 days of receipt of the written notice,
whichever occurs first.
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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