Approval of Methods for Standard Methods for the Examination of Water & Wastewater

Andrew D. Eaton
Joint Editorial Board - AWWA Representative
MWH Laboratories Monrovia, CA

The Standard Methods Organization

3 Joint Editorial Board Members AWWA, WEF, APHA 10 Part Coordinators Various Experts in Different Areas Serve as Managers for those Parts 1 Standard Methods Manager AWWA Employee Handles balloting, etc. 1 EPA Liaison - Herb Brass (EPA-Cincinnati)

The Standard Methods Organization

1 Editor Ensures that everything is in consistent format Up to 250 Joint Task Group Chairs Experts on specific methods Ensure that methods are current and have appropriate QC 500+ members of Standard Methods Committee (SMC) Ballot each method to achieve consensus

The Standard Methods Process

It can take from 3 months to 5 years to produce a method for Standard Methods Depends on motivation of the committee Depends on quality of information in the method (validation, verification, etc) Depends on where things are in the Standard Methods process for balloting

The Standard Methods Process Some Details

JEB or PC or External folks see a need to produce a new method PC recruits experts and forms a JTG PC and JTG put together a charge JTG prepares a method JTG ballots a method within JTG JTG cant agree on details of the method or cant get validation studies done Method languishes

Standard Methods Process A Method Moves Forward a Bit

Validation study completed and JTG achieves consensus Final JTG method goes to JEB/Editor for wordsmithing Final method balloted by full SMC SMC member has a specific technical objection (negative vote) backed up by details Method returned to JTG for review and revision May require further testing with the proposed changes

Standard Methods Process A Method Makes it to the End

Revised validation study completed and JTG achieves consensus Goes back to full SMC for re-ballot Note you can only vote on a re-ballot if you voted on the first ballot Consensus achieved by full SMC Method goes to JEB Liaison, PC and (sometimes) JTG chair for post-ballot editing (to address editorial comments from SMC) Final method (after post ballot editing) goes to Editor for finishing off Method goes to printer to produce pdf version.

So Where Can Things Get Hung Up?

At the JTG - if they dont agree on details At the PC/JEB - if theyre not satisfied that method is ready for prime-time At the full SMC level - if there are specific technical objections At the PC/JEB level (again) - if technical objections werent addressed adequately By the production process itself By the publisher (things slip)

The EPA Approval Process for Standard Methods

Must comply with the Administrative Procedures Act (APA) All methods subject to EPA approval are reviewed by EPA Staff If a method is unchanged, it still must be reviewed (to verify the lack of changes) SM provides strikeout/revision modes to EPA to facilitate review A change in a referenced section (e.g. 3020) can impact the approval of another section (e.g. 3120)

The EPA Approval Process for Standard Methods

EPA tried to use the Direct Final Rule approach to get unchanged methods (or minor changes) approved But it didnt work Because almost any comment is considered adverse, which means the method must go through a proposal/promulgation cycle, which greatly lengthens the approval process (from 90 days to 1-1.5 years). Sometimes it almost does - 3125 cited for Uranium in the 8/25/04 Rule

Why Did EPA Not Approve Everything in the 20th Edition?

EPA does not approve books - they approve methods EPA does not approve methods for constituents that arent regulated - so you can use any method you want...

Example 6040D - Taste and Odor

SM dropped many methods because the consensus was that they were not used or had inadequate precision

Example Uranium by Fluorometry (7500-U C) is still

approved from the 17th edition, but was replaced in later editions with Uranium by Alpha Spectrometry (with the same designation)

More on the 20th and the Online Edition and Approval

EPA reviews each method to see what, if anything, changed from the prior edition If nothing changed its usually a slam dunk Even minor changes require review On the wastewater side, EPA seldom sunsets a method, because they will be sued On the drinking water side, methods are constantly being updated (more QC) Thus some methods may be approved only in one Edition and not in others

Standard Methods and QA/QC

This falls into the FAQ category Standard Methods was not originally designed as a book for regulatory compliance, so you dont find the same details on QA/QC that you do in EPA methods. But Weve been gradually tightening that up via the 020 sections - which spell out the required QA/QC for compliance testing (and also for getting better quality data)

How are We Addressing the Complaint About Lack of Enough QA/QC in Standard Methods
Reviewing each part and writing a new 020 section (QC) that will have: Standard QC elements for methods for compliance QC Acceptance Criteria by Analyte Category or Analyte for compliance testing When EPA approves a method, it includes the 020 section for that part EPA is reviewing proposed changes for consistency, before we go out to ballot

Standard Methods and QA/QC

Sometimes enhancing the 020 section can backfire We added a lot of QA/QC elements to 3020 in the 20th edition, but also tried to make it generic to cover all methods in part 3000 and inadvertently therefore loosened the QA/QC for 3111/3113 (Flame and GFAA)so EPA did not approve it (even though 3111 did not specifically reference 3020) Note - we fixed this for the 20th Supplement: a user must use the TIGHTER of the criteria in the 020 section or the method and in the ONLINE edition weve made it even more clear

How Does This Impact EPA Approval?

Even though the 20th Edition supplement fixed the 20th Edition problem, it wont help till the next cycle of EPA approvals for methods some corrections got taken care of in the MUFRN Rule of last spring but not all. Any changes made to an 020 section requires reapproval by EPA of all affected sections

Standard Methods Online

AKA 21st edition (more revisions folks..) More detailed QA/QC throughout Parts (were getting there gradually.) Several new methods in most sections - significant changes in a number of areas. Most importantly - we can add new methods more frequently
6610 - Carbamates - totally rewritten and will be posted soon 6710 - Butyl Tin - new method and will be posted soon A number of microbiology methods under revision

Standard Methods Online website:

www.StandardMethods.org

Questions?
Please contact me at andrew.eaton@mwhglobal.com or volunteer at www.standardmethods.org