Updated analytical method rule changes

The U.S. Environmental Protection Agency (EPA) recently updated some analytical methods and rule chapters for environmental laboratories. Our Laboratory Accreditation group administers this rule.

Clean Water Act analytical methods updated

On Aug. 28, 2017, EPA published the Methods Update Rule-2017.

The changes included:

  • New and revised EPA methods (including new and/or revised methods published by voluntary consensus standard bodies (VCSB), such as ASTM International and the Standard Methods Committee)
  • Updated versions of currently approved methods
  • Methods reviewed under the alternative test procedure (ATP) program
  • Clarifications to ATP approval procedures
  • Revised Method Detection Limit (MDL) procedure

The new regulation went into effect on Sept. 27, 2017

We began accrediting labs for the latest approved methods immediately after the rule took effect. We require that accredited laboratories begin using the new MDL procedure for their next regular annual MDL studies.

Laboratories will have a year to update their Standard Operating Procedures (SOPs) to conform to the newer versions of the methods. When we process accreditation renewals, we will update Scopes of Accreditation to the new approved methods. Laboratories do not need to send us revised SOPs, but have them ready and available for our review at the next routine on-site audit. Any requested scope revisions for non-potable water matrix processed on or following Sept. 27, 2017, will be for the new methods.

Laboratories conducting EPA 600 series methods will have a year to comply with the new method versions, due to substantial changes.

Solid and chemical materials methods updated

Update VI — July 2018

EPA finalized changes in Solid and Chemical Materials methods (SW-846 Update VI, Phase II) as of July 12, 2018. 

The changes include two organic methods (8260D and 8270E) for the analysis of volatile and semi-volatile compounds in solid waste and various other environmental media using gas chromatography and mass spectrometry (GC/MS).

These two major organic methods have been revised to include the addition of new analytes and preparation methods, the option of hydrogen as a carrier gas, the use of advanced measurement techniques (e.g., selected ion monitoring, chemical ionization, tandem mass spectrometry), and updated language for lower limit of quantitation and method blanks. In addition, tuning requirements were updated to harmonize with other EPA program methods.

What's next?

We will begin accrediting laboratories for EPA methods 8260D and 8270E from Aug. 12, 2018 through Aug. 11, 2019, at laboratory request only.
 
Beginning Aug. 12, 2019, scopes will be automatically updated to EPA Methods 8260D and 8270E in place of the previous method versions. Laboratories will have one year (through Aug. 12, 2019), to implement the updates for these methods and to update their Standard Operating Procedures (SOPs) to conform to the newer versions of the methods.

Exceptions will include laboratories seeking recognition of a third-party accreditation where their primary scope has not yet updated to SW846 Update VI Phase II Methods. Those laboratories will have an additional year (through Aug. 12, 2020) to have their primary scopes updated.

Method citations for Proficiency Testing (PT) studies should match the lab’s current scope of accreditation, current SOPs, and the method used in the laboratory. Laboratories in transition may choose to report PT studies for both new and old method versions.

We will accredit only in the Solid and Chemical Materials matrix for these methods.

Update V — August 2015

We expect labs accredited for Organics 8000 series methods to use and comply with the requirements in Method 8000D, even for older methods that reference 8000C.

When we process accreditation renewals, we update Scopes of Accreditation to the Update V methods. You do not need to send us your revised SOPs, but have them ready and available for our review at the next routine onsite audit.

Other revisions for chapters 1 through 5

In addition to method updates, Update V also includes revisions to Chapters 1-5 of SW-846. Chapter 1 replaces MDL with “Lower Limit of Quantitation (LLOQ),” defined as the lowest point of quantitation which, in most cases, is the lowest concentration in the calibration curve. The LLOQ is verified periodically with blank spikes, also known as Laboratory Control Samples (LCSs) using lab-specific statistically based recovery limits, or project limits. For more detailed requirements for the LLOQ, please see section 9.8 of 6010D or 6020B or 9.7 of 8000D.

Note that your Quality Assurance Project Plan (QAPP) requirements supersede method requirements for a given project. That is, if a QAPP specifies MDL (not LLOQ) requirements, then those are the requirements that must be met for that project. If a QAPP specifies SW-846 methods, but does not specify MDL or LLOQ, then the current LLOQ requirements will be the default. The Laboratory Accreditation Unit does not specify the requirements in QAPPs.

For questions on LLOQ requirements, please contact Rebecca Wood, 306-871-8811, for metals or Kamilee Ginder, 360-871-8841, for organics.