Information on the 2012 EPA Method Update Rule
On May 18, 2012, EPA published a final rule that approves new methods, or changes to existing methods, that affects over 100 EPA methods, Standard Methods, ASTM methods, and other test procedures in Part 136 of Title 40 of the Code of Federal Regulations (CFR). The rule also contains a number of clarifications relating to approved methods, sample preservation and holding times, and method modifications. Among the more significant changes is a new section 136.7 that would require "essential" quality control activities. The rule will go into effect June 18, 2012. A copy of this rule and related information can be found on EPA's Office of Science and Technology website at: http://water.epa.gov/scitech/methods/cwa/update_index.cfm.
TNI has developed this page to provide additional information about the rule, including correspondence from EPA since May 18, 2012.
Standard Methods
EPA has changed how approved methods that are published by Standard Methods are identified. EPA now approves only the most recent version of a method published by Standard Methods by listing only one version of the method with the year of publication designated by the last four digits in the method number (e.g., Standard Method 2320 B-1997). TNI has prepared a table that lists all methods showing the approval year for various editions of Standard Methods at http://www.nelac-institute.org/lams/test_methods.
On June 20, 2012, EPA prepared a memo approving 115 methods from the 22nd edition of standard methods. The memo indicated that all of these methods were editorial changes and contained this statement:
For a method that is approved in more than one edition of a compendium an analyst must, at a minimum, follow the QA/QC in that edition. To improve consistency and ensure reliable results, laboratories are encouraged to phase-in and adopt the QA/QC procedures specified in the most recent, approved editions of that compendium.
The Standard Methods Joint Editorial Board has additional information at: http://www.standardmethods.org/ViewArticle.cfm?articleID=96 that indicates these editorial revisions primarily relate to the references to the revised QA/QC section in Parts 2000, 3000, 4000, 5000, 6000, and 7000. These sections can be identified by the addition of "editorial revisions" in the title.
The memo and a related table showing all the approved methods by analyte are available here:
EPA Memo on the 22nd Edition of Standard Methods (PDF)
EPA Listing of Methods and Analytes (Word)
On June 21, EPA noted 2 corrections needed to be made to the table:
3113B- 2004 there is no 2011 update
6200C-1997 should be 6200C-2011
On June 20, EPA verified that either method listed in this table can be used for compliance monitoring and provided this additional clarification:
we encourage you phase-in and adopt the most recent approved editions; really up to the State and/or accrediting authority.
Implementation of the Rule
EPA understands that the rule will need to be adopted by state agencies responsible for various water/accreditation programs within their state and issued this clarification in an email:
EPA is aware that it is not practical to require every state, laboratory and permittee to implement changes that quickly, particularly since different states have different requirements. You are correct that it would be very difficult for EPA to impose deadlines for each state to meet all the changes in the final rule. Therefore, we recommend that changes brought about by this rule be made when permits come up for renewal, when a brand new permit is issued, or otherwise as specified by the permitting authority.
Essential Quality Control
On June 14 EPA has provided clarification statement about the new Section 136.7.
With regard to the recent addition of Part 136.7 - Quality Assurance and Quality Control, the intent of the addition of this part was to codify that a permittee or laboratory is required to use suitable QA/QC procedures when conducting CWA compliance analyses.
In cases where methods listed in the tables at 136.3 do not contain QA/QC procedures as a part of the method or the compendium from which the method was taken (e.g., older EPA Methods that were originally published in Methods for the Chemical Analysis of Water and Wastes) , options were given to comply with the QA/QC requirements.
These options included:
1) Referring and following QA/QC published in the "equivalent" EPA Method for that parameter that did contain QA/QC procedures,
2) Referring to the appropriate QA/QC section(s) of an approved Part 136 method from a consensus organization compendium (such as part 1000, 2000, 3000, etc. of Standard Methods), or
3) Incorporating the applicable QA/QC into the laboratory's SOP.
Our intent was not to allow people to "shop around" to determine which QC (and/or acceptance criteria) they wanted to use. The intent was that if a permittee or laboratory is using a method from "Standard Methods for the Examination of Water and Wastes", they would refer to the appropriate section of Standard Methods for QA/QC requirements. All laboratories should have SOPs that document the procedures that they use to analyze samples for various parameters by various methods. If a laboratory's SOP for a analysis of samples for a particular parameter references a method from Standard Methods then the SOP should include the QA/QC requirements and acceptance limits from Standard Methods.
It was not our intent for approved methods with existing QA/QC to be updated to include additional QA/QC procedures. Rather 136.7 address methods that did not contain QA/QC or where the QA was found in a different part of the methods compendium. If an approved method with QA/QC does not contain all 12 elements listed at part 136.7; it is not recommended or required (unless required by the permitting authority) that a laboratory add the missing elements. In many cases this would require a laboratory to establish acceptance criteria for QC elements which are not appropriate for a specific method (e.g., adding MS and MSD tests to a method that measures dissolved oxygen).
Methods for Dissolved Oxygen
On June EPA has provided clarification about methods for dissolved oxygen.
In the most recent Method Update Rule that was published in the Federal Register on May 18, 2012, (77 FR 29758), EPA has added luminescence based sensor technology for measurement of dissolved oxygen (DO) to Table IB at 40 CFR Part 136.3.
Three methods that use luminescent based sensor were added to the list of approved methods for measurement of DO.
In addition to the two methods that were developed by instrument manufacturers and submitted for approval through the ATP program, (Hach Method 10360 and In-Situ Method 1002-8-2009), one method developed by a Voluntary Consensus Standard Body (VCSB) ASTM D888 Standard Test Methods for Dissolved Oxygen In Water, Test Method C - Instrumental Probe Procedure- Luinescence-Based Sensor was included in the list of approved methods. This method does not specify a particular make or model of sensor. Therefore, any luminescence-based sensor that meets the requirements of the method may be used.
TNI Discussion Board
A thread has been developed on the Small Laboratory Advocacy Group discussion board to allow anyone to post questions and comments about this rule. Click here to visit the TNI Discussion Board.