Proposed VAP Rule Revisions April 2, 2019
300-01 Definitions • Clarifications and additions to existing definitions support revisions to other rules. • Add new definitions for: – “Bioavailability” – “Central Management Entity” – “Construction Activities” – “Pathway Deferral” – “Pathway Exclusion” – Definitions of varying land use types
300-02 Eligibility Proposed edits – VAP sufficient evidence trigger – Director’s “enforcement letter” triggers option to show sufficient evidence of entry into VAP – Removed from letter definition: “with proposed director’s final findings and orders” – Thus, enforcement letter w/o draft DFFOs would trigger sufficient evidence option
300-02 Eligibility Proposed edits – VAP sufficient evidence trigger – Rule -02(C) conditions for showing sufficient evidence include: • Began voluntary action work • Scheduled remaining tasks • Continued progress – Conditions N/A only should Ohio EPA take no enforcement action within a year after the letter • Removed “or a determination of sufficient evidence”
300-03 Fees • All fees to remain the same • No substantive changes made • Only structural changes made to the rule to allow for congruence with other agency rules
300-04 Certified Labs New Approach to Laboratory Certification – Recognizing NELAP Accreditation – Standardizing QAPP and SOP Requirements – Performance Testing Program – Laboratory Auditing – Renewal Certification – Administrative and “Housekeeping” Changes
Recognizing NELAP Accreditation • The NELAC Institute -- National Environmental Laboratory Accreditation Program (NELAP) – Optional - Not required for VAP certification • Reliance on NELAP accreditation means… – Streamlined certification and auditing – More than one “set-of-eyes” overseeing laboratory • Ohio EPA retains ability to ensure quality – Laboratory auditing – Compliance enforcement
Streamlined Laboratory Certification with NELAP Accreditation • Certification Requirements – Application w/Affidavit – Quality Assurance Program Plan (QAPP) – Standard Operating Procedures (SOPs) – Proficiency Testing Results – Method Detection Limit Study – Laboratory Audit • Documentation of NELAP Accreditation – Show accreditation is in “Good Standing” – Show accreditation’s for analytes, parameter groups and methods
Streamlined Laboratory Auditing with NELAP Accreditation • Laboratory Auditing – Review VAP Lab Reports – Review QAPP and SOPs – Proficiency Testing Results (new) – On-site Visit • Laboratory can demonstrate NELAP accreditation during compliance audit
Standardizing QAPP and SOP Requirements • Must comply with Method requirements – U.S. EPA SW-846 test methods • Ohio EPA has additional minimum requirements – Consistent with current requirements • Performance-based testing may require additional requirements
Changes to How Labs Comply with Minimum Requirements • Current rule requires Ohio EPA review and approval of QAPP and SOPs – Any changes have to be reviewed and approved prior to use by lab – Ohio EPA can not require updates to QAPP or SOPs – Approved documents may not be consistent across all labs • Proposed rule changes – Rule has specific minimum requirements labs must follow – Labs responsible for meeting minimum QAPP and SOP requirements – Lab can update QAPP or SOPs at any time without Ohio EPA approval
Agency Specific Requirements • Content of VAP Laboratory Report Ohio EPA Approved • Data Interpretation and Reporting Requirements • Instrument Calibration Requirements • Quality Control • Preparation of Samples • Analysis of Samples • Additional QAPP Requirements
Content of VAP Laboratory Report • CL Affidavit • Case Narrative – List of expected information to include in narrative • Analytical Results • Quality Control Sample Results • Chain of Custody • Sample Receipt Form – List of expected information to document on form
Laboratory Auditing – When Is It Done? Current Rule Proposed Rule • Initial certification • Initial certification – Required – Required, except discretionary w/NELAP accreditation • Add-on certification • Add-on certification – Discretionary – Discretionary • Compliance audits • Compliance audits – Will be conducted periodically – Will be conducted periodically at Ohio EPA’s discretion at Ohio EPA’s discretion
Laboratory Auditing – What Is Involved? Current Rule Proposed Rule Definition requires on-site Definition doesn’t require on-site • • visit of laboratory visit of laboratory Review of requested Review of requested • • information and on-site visit information and/or on-site visit Review of analytical reports Review of analytical reports • • Compliance with approved Compliance with minimum • • SOPs/QAPP requirements for SOPs/QAPP PT samples (optional, unless • required by rule)
Updating the Performance Testing Program • When are performance testing (PT) samples required? – Current rule only requires PT samples during initial or additional certification – Proposed rule also allows Ohio EPA to request PT samples at anytime [i.e., “tool-in-toolbox” for auditing] • What kind of PT samples are required? – Current rule only requires testing of water samples – Proposed rule will also require testing of solid matrix samples • Proposed rule allows laboratory to rely on NELAP accreditation in lieu of PT samples
Renewal Certification • Relaxed timeframe for submittal of renewal application – If less than 90 days before expiration, certification may lapse – Certification period extended from 2 to 3 years • Relaxed renewal options for additional analytes/methods – Can now add analytes/methods at renewal – Director may renew for previously certified analytes/methods, then add additional analytes/methods later
Renewal Certification • Director may delay renewal of certification past the expiration date, if deficiencies identified during a laboratory audit remain unresolved • For certification relying on third-party accreditation, proper documentation that accreditation remains in “Good Standing” is required • Laboratory may “switch” certification at renewal to rely on maintaining NELAP accreditation
300-04 Administrative and Housekeeping Changes • A Certified Laboratory (CL) may withdrawal from program – Certificate must be returned and cannot report certified data • CL required to report loss of third-party accreditation, when relied upon for certification – CL violates standard of conduct if it issues certified data when third-party accreditation is not in “Good Standing”
300-04 Administrative and Housekeeping Changes • Clarified that proper citation of method numbers includes use of the revision suffix (e.g., Method 8260 B) • Clarified steps for reinstatement of a suspended laboratory • CL cannot report samples from Tedlar bags as certified data
300-04 Administrative and Housekeeping Changes • Clarified that certification is limited only to hazardous substances or petroleum (or their components) • Clarified that a CL can only report analytes specified in the method, unless certificate states otherwise – Exceptions to certified data shall be noted in the CL affidavit • Unless CL is informed of the need for lower applicable standards, CL shall quantify at or below the single chemical generic numerical standard – OAC 3745-300-08 -- [Appendices A and B] – CL must notify, in writing, that it is not capable of detecting COCs at or below the applicable standard
300-05 Certified Professionals Added to 3745-300-05 (A)(2)(c) • (iv) Previous performance of the individual with regard to past performance working with Ohio EPA Added to 3745-300-05 (A)(2)(c) • (vii) Performance of the individual with regard to evaluating laboratory data quality and sufficiency to conduct a voluntary action • Electronic Submittals • Shortened Renewal Grace Period
Procedure for Renewal of Certification Revision to 3745-300-05 (C)(13) • If the director determines that the certified professional has not submitted documentation of a completed application or the certified professional has not complied with a standard of conduct in performance of professional services as described in this rule, the director may deny the certification renewal application. If the director denies renewal of a certification, the director shall provide a letter that describes the reasons for the denial of certification renewal.
300-06 Phase I • Aligned VAP to be more consistent with ASTM standards • Clarified language where rule requirement has not been fully understood • Added paragraph headers
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