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QA Rule Changes
 

Chapter 62-160, F.A.C. – List of Changes to the 2008 Quality Assurance Rule

The following is a summary of the changes to Chapter 62-160, FAC. Please contact Michael Blizzard for further information.

Rule Change
62-160.110 Clarifies the scope and applicability of the rule for all entities and activities that are a part of the sample collection and laboratory analysis process.
62-160.120 Adds a definition for common carrier. Adds a definition for commercial vendors, who are exempted from the scope of the QA rule, with an exception for organizations that purchase commodities with the intent of providing the commodities as a service to clients, whose activities do fall under the authority of the rule. Revises the definition of data quality objectives. Adds a citation to Chapter 64E-1, F.A.C. as a reference for lab certification requirements. Adds a definition for electronic signature. Revises the definition for Method Detection Limit (MDL). Clarifies that MDLs shall be determined for each matrix/analytical technology/analyte combination reported by a lab. Adds a provision to allow calculation of MDLs by any technically justifiable and scientifically sound method other than those prescribed in this rule, when a specific method is not required by a Department program. Adds clarifications for certification requirements for the analyses of TCLP extracts derived from matrices defined as solid or chemical materials. Revises the definitions of National Environmental Laboratory Accreditation Conference (NELAC)/Program (NELAP). Deletes the definition for data rejection. Adds a definition for secondary-use data.
62-160.210 Clarifies the types of organizations that must comply with the requirements of DEP-SOP-001/01 (DEP SOPs).
62-160.220 Adds three SOPs to the list of biological procedures than cannot be modified or for which an alternative procedure cannot be substituted. Revises language and adds new requirements for providing notice (by DEP) of the approval or disapproval of requests to use new or alternative procedures and for the recission of previously approved procedures. Revises and adds language about the right to an administrative hearing under Chapter 120, F.S. regarding such approvals and disapprovals.
62-160.240 Clarifies the intent and scope of the documentation and reporting requirements in this rule section for entities that conduct or support field activities and field measurements. Adds the requirement that specified records shall contain sufficient information to allow independent reconstruction of all activities related to generating data submitted to the Department. Clarifies that DEP may request specified field records for a sampling site or facility at any time.
62-160.300 Clarifies the definition of sample matrix for lab certification. Revises certification requirements for flexibility in reporting methods and analytes for compliance with DEP non-potable water regulations where multiple methods using the same analytical technology are available. Adds a provision, requiring certification, for reporting drinking water methods for non-potable water analyses when non-potable water methods have not been published for analytes. Clarifies that DEP allows certification based on the analyte/matrix/analytical technology combination for non-potable water and on the analyte/matrix/test method combination for all other matrices. Adds a requirement that a lab must make a written request to the Department for approval (under certain conditions) to use a method for which it has not completed all of the certification steps. Adds to the list of tests exempted from lab certification requirements: turbidity (both lab and field methods are now exempt); bacteria tests for remediation activities (usually applicable to contaminated sites); and, any method in which the reported result is a calculation using the results of other certified methods.
62-160.320 Cites Federal Register updates to EPA-approved lists of methods for compliance analyses related to the Clean Water Act and Safe Drinking Water Act, and provides a 6-month grace period after the effective date of the QA rule (12/3/08) for laboratories to make any necessary changes to certification status to reflect these updates. Adds the Lake Vegetation Index calculation to the list of procedures requiring the use of DEP-SOP-002/01 (DEP SOPs) to be used for certain biocriteria applications.
62-160.330 Adds the Lake Vegetation Index (DEP SOP LT 7500) to the list of determinative procedures for which an alternative method cannot be approved. Adds new requirements for providing notice (by DEP) of the approval or disapproval of requests to use new or alternative analytical methods and for the recission of previously approved methods. Adds language about the right to an administrative hearing under Chapter 120, F.S. regarding such approvals and disapprovals. Adds a citation to 40 CFR, Part 136.6 to the list of federal rules governing the approval of alternative analytical methods for NPDES compliance.
62-160.340 Clarifies the intent of this rule and revises lab documentation, archival and reporting requirements. Adds requirement for lab records to contain sufficient information to allow independent reconstruction of all events linked with data submitted to DEP, and to support the analytical report described in this rule. Adds requirement for the lab to provide records or copies to DEP when requested. Adds reporting requirements and exemptions for "in-house" ("captive") labs. Clarifies requirement to report data in specified paper or electronic formats when required by DEP. Adds citation to NELAC standards for re-issuance (amendment) of lab reports. Adds language prohibiting alteration of data or deletion of data qualifier codes originally reported by another party, unless specifically directed to do so by DEP, when data are submitted to DEP in summary, re-published or reduced form, where the altered data changes the meaning or numerical significance of the original data. Requires the submittal of original lab report(s) with re-worked data. Adds requirements for entities other than the data originator who add data qualifier codes to the original data through validation or review independent of the originator's reporting activities. 
62-160.405 Adds a new section on minimum requirements for electronic signatures accepted as equivalent to written signatures by DEP.
62-160.650 Revises the calendar for Department issuance of preliminary reports subsequent to audits and the time allowed for the audited party’s required response. Deletes language about rejecting data based on the audited party’s lack of response and replaces it with an intent to not recommend use of the affected data  to the applicable DEP program(s). Also clarifies the Department’s obligation to issue a final response to the audited party and any other substantially affected interests. Revises and adds language about the right to an administrative hearing under Chapter 120, F.S. regarding the final response.
62-160.670 Clarifies and adds language describing how the Department will evaluate data quality indicators (DQI) for specific uses of data designated by Department programs, when conducting audits, data validations or other types of data review. The list of general criteria and concepts by which data is assessed and validated is expanded. Adds language to clarify the relationship between data usability evaluations and original vs. secondary uses of data. In support of the changes to 62-160.670, a document, "DEP Process for Assessing Data Usability", DEP-EA-001/07 is incorporated by reference to further detail the process for assessing data usability. Deletes language in this section describing when the Department may reject data, including language about rejection of data based on lab certification status, and deletes the procedure for issuing a notice of intent to reject the data.
62-160.700 Revises and adds to the list of data qualifier codes (Table 1): D, I, J, M, V, Z (all revised) and X (added).
62-160.800 The list of documents incorporated by reference into the QA rule is updated. Two of the references have been revised as part of the proposed rule changes and comprise the Department’s Standard Operating Procedures for specific field and laboratory activities (DEP-SOP-001/01 and DEP-SOP-002/01). A document, "DEP Process for Assessing Data Usability", DEP-EA-001/07, is incorporated by reference to further detail the process for assessing data usability. Other selected references are added or deleted.

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Tallahassee, FL 32399
850-245-8346
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Last updated: May 05, 2014

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