We shared news from the second AOAC INTERNATIONAL Analytical Methods Week of 2020 in this live blog.
AOAC’s Senior Director of Standards Deborah McKenzie just touched on ethical considerations of participating in an AOAC ERP in the wrap-up to Analytical Methods Week’s kickoff presentation, “AOAC Orientation: ERP – New Methods through Final Action OMA Status.” Attendees have learned about adoption of methods, tracking of First Action Official Methods of Analysis and requirements for changing the action status of Official Methods of Analysis.
Publishing a technique in a peer reviewed journal can be a start, but it is not enough to meet the high bar of AOAC Official Methods, says AOAC’s Senior Director of Standards Deborah McKenzie.
A practical step is writing the method into AOAC format. Can it be followed easily? Is it specific on applicable matrices or commodities, including limitations? Authors should be familiar with AOAC’s suite of available resources to be successful in their submission, including a consulting service, training, and web resources.
McKenzie is sharing these and other insights for method authors in AMW Session 2, “Developing the Ideal Candidate Method Submission Package for Review by AOAC Expert Review Panels – Basic Guidance for Method Authors.”
We’re into the Q&A of the second webconference of Analytical Methods Week:
Dr. John Szpylka, reporting out from the Non-Targeted Testing Standard Method Performance Requirements (SMPRs) working group, is kicking off this session with a review of comments received on the three draft SMPRs participants in this virtual meeting will be voting on.
Both Targeted Testing and Non-Targeted Testing SMPRs were developed for honey, milk, and extra virgin olive oil. Learn more about the project here.
One comment was that “30 validation samples is rather few” but Szpylka noted that this still allows a 95% confidence level while not overburdening the lab.
Voting has opened and we’re moving on the targeted testing as votes come in.
Dr. Joe Boison, Chair of the Targeted Testing Working Group, has just finished reporting out on comments received on the three draft SMPRs for targeted testing.
In response to a question on the call, AOAC staff assured participants that they did not need to be an AOAC member to vote and noted that several participants in the discussion are not on the working groups.
Dr. Boison noted that comments received have been largely text edits but asked for feedback on a few more substantive issues, such as precision ranges. With no input received, we are proceeding to a vote on approval of these SMPRs.
Voting is open through June 30.
We’ve just heard that the Sulfites in Seafood Expert Review Panel, scheduled for this Thursday, is tentatively rescheduled for July 8, 2020. See the updated schedule.
ALL stakeholders can share perspectives, and none has greater influence than another in an AOAC stakeholder program or project, said AOAC’s Deborah McKenzie, Senior Director of Standards ask she kicked off the Analytical Methods Week Orientation session underway now.
After a 10,000-foot summary of AOAC’s history, geographic reach, and influence, McKenzie gave a detailed review of AOAC’s standards development process from kickoff in the Advisory Panel Meeting to Working Groups, community consensus, draft standards, and finally approval of the standard.
She touched on AOAC’s auxiliary information and services like the Performance Tested Methods program, AOAC’s Consulting Service, and Education & Training.
We’re now getting details on how standards go from approval to publication in the Journal of AOAC INTERNATIONAL and in the Official Methods of Analysis.
Here’s the scoop on standards development:
==> Advisory Panel meeting
==> Launch of new Working Group activities
==> Working Group meetings
==> Draft standard public comment period
==> Community consensus
==> Approval/publication of standard
We’re hearing about First Action method approval and the built-in controls of AOAC’s process, including the definition of an ERP quorum and how repeating ballots play out when approval is not unanimous on the ERP.
The process is flexible: A method may be approved even if it does not meet every aspect of an SMPR – so long as it is scientifically sound and meets the needs of those using the method, the ERP sees evidence of high potential to First Action with additional work, and the Official Methods Board receives a justification or rationale.
“We don’t want a commercial, we want honest positive and negative feedback,” advised Deborah McKenzie as she wrapped up this session with an overview of the road a method takes from First Action to Final Action status. She reminded attendees how critical the stakeholder community is not just in developing methods but ensuring they work in rigorous real-life situations.
The Expert Review Panel reviewed a candidate method for Sugars in Animal Feed, Pet Food, and Human Food applying Ion Chromatography with Pulsed Amperometric Detection (IC-PAD). No methods were approved.
An AOAC ERP discussed a recommendation for potential action status change to AOAC 2017.16, Total Dietary Fiber in Food and Food Ingredients by Rapid Integrated Enzymatic-Gravimetric–High-Pressure Liquid Chromatography Method. The change related to the removal of isomaltose and lactose which interfere with accurate measurement of FOS by HPLC. Megazyme President Barry McCleary reported back on positive feedback from three labs that evaluated a proposed solution to the problem.
AOAC 2017.16, Total Dietary Fiber, was originally adopted in December 2017 as a First Action method. Today, Chair Lars Reimann led the ERP members through the reviews submitted and supplemental information on the method.
The ERP agreed that the addition of the footnote and an additional diagram satisfies the requirements of the ERP from a previous review meeting, and that the method should advance to Final Action status. As the ERP did not have a quorum, the final vote will take place following the meeting by ballot.
The ERP also reviewed a candidate method for measurement of Available Carbohydrates. Barry McCleary of Megazyme described the method, which he said worked on pretty much every matrix they looked at, and took a new approach by measuring directly rather than by difference.
Several ERP members wondered about where this method fits in, in relation to labeling, since available carbohydrates is not currently a requirement. McCleary agreed, but noted that “Our job is to get the science right, provide a validated method that works; what the FDA does with it is out of our hands.”
Revisions recommended include:
The ERP asked McCleary to update the method based on this feedback and resubmit for a follow up review and vote.
The ANSI accredited US TAG to ISO/TC 34 was the last meeting of the June Analytical Methods Week. The TAG members met and with an engaging discussion on open ballots, the needs of the US Food products community, and ideas for increasing participation and engagement.
The rescheduled meeting of the Expert Review Panel (ERP) for Sulfites Methods is a little over an hour and a half into review of a method for Total Sulfites in Shrimp. Previously, the BIOFISH 300 SUL test kit was certified through the AOAC Performance Tested Methods program. Today the manuscript for this method, submitted by Biolan Micobiosensores S.L, is being considered by the ERP as Total Sulfites in Shrimp for Official Methods First Action status.
The meeting kicked off with ERP Chair Cheryl Lassitter of the U.S. National Oceanic and Atmospheric Administration (NOAA) welcoming participants, after which one of the method authors presented the paper. ERP members are now reviewing together the questions and issues raised by members in their individual reviews. AOAC’s review process includes some 20 feedback questions, such as “Are the references complete and correctly annotated?” and “Are there any concerns regarding the safety of the method?” that ERP reviewers can comment on.
Although the group is one members short of a quorum, members are moving on to the main question: whether to recommend that the ERP adopt the method as an AOAC Official Method of Analysis. Several action items are being reviewed. Stay tuned!
Final consensus is that the method authors need to provide a few more pieces of information, after which the ERP will vote by e-ballot on whether to approve the method as a First Action Official Method.
AOAC’s Deborah McKenzie concluded the meeting by asking the ERP one final question: If the method is approved for First Action status, is there is any additional information they will want to consider before the method advances to Final Action? Members have already submitted some ideas in writing, but a few more input is being added in the wrap up discussion.