Food Sciences Section (FSS) Section Executive Committee Meeting

Held during Annual ACIL Meeting- Scottsdale Arizona

October 6 2013 1-5pm Meeting Minutes

Participants:);Jeff Abels – Chair (FTS); Dave Kliber(S-F Analytical Labs);Joe Konschnik (Restek); Kelley Feist (ACLASS); Lars Reimann (Eurofins); Milton Bush (ACIL CEO); Mike Olson (ACIL); Susan Schimelfining (OMIS USA); Mary Kay Krogull (Eurofins); Thomas Berg (Minn. Valley Testing Labs); Gina Bellinger (FSNS); John Bellinger (FSNS); Michael Flourney (Microbac Labs); Trent Sprakle (Restek); Kunal Rehani (Sigma-Aldrich); Zoe Grosser (Horizon Technology)

1.0Call to order:

Mr. Abels called the meeting to order at 2:00 pm PST.

2.0Introductions:

All attendees introduced themselves.

3.0Anti Trust Statement:

Mr. Abels read the Anti Trust Statement and members acknowledged they understood their obligations under the statement.

4.0 At this point the conversation started but could be summarized under general topics

Pesticide validation study being organized by CFSAN/FDA.

Joe Konschnik reported on the status of the method study for a multiresidue method for pesticides in foods. Joe has reported on this before. The method employs QuECHERS extraction and LCMS detection. John Wong (CFSAN) has been the principle investigator on this project to validate this procedure. The initial labs were mostly government labs using the same MS equipment. The samples have been sent out and most of the results have been returned to John. However, due to other priorities and the Federal Shutdown, he has fallen behind on his timetable. The next phase will expand the pool of laboratories and all brands of equipment and will include independent laboratories. ACIL members will be hearing more about this as the project advances. This will be a good opportunity for ACIL member labs to be involved in the validation and be prepared to implement the method when the validation is completed.

FDA Meeting

Mike Olson reported on a recent meeting between ACIL and member labs and the Office of Regulatory Science ORA/FDA. This meeting was the latest in a long line of meeting about the ORA Private Lab Review program. When the FDA places an importer/shipper/product/country on detention without physical examination, the product is detained on entry and the importer must have the product analyzed by a private laboratory for the particular a problem in the import alert. The FDA field laboratories meticulously review the analytical reports before the product is released. The FSMA requires that these laboratories will have to be accredited at some future date. FDA is currently drafting regulations to implement this requirement.

The following was the highlights of the meeting:

FDA will look into an issue raised by a member organization about making an appointment to sample the import entry. This requirement reduces the flexibility of the sampler and actually serves no real purpose.

FDA will look into placing the sampling instructions and analytical method (citation) in the import alert. The can add additional requirements so everyone is on the same page before the sampling and analysis begins.

ACIL will work with FDA to set up a session with four private labs identified by FDA as high volume labs to hear first hand exactly the problems they have with the review process.

FDA will be providing training to the reviewers on review policies. They also offered a training program for the private labs. Milt Bush offered the assistance of ILI in this endeavor.

FDA provided a draft checklist for field reviewers to review microbiology worksheets. ACIL is providing comments on the checklist.

Milt Bush offered to have ORS on the FSS monthly call to provide an avenue for dialog with the private labs.

ACIL continue to advocate for the use of COA’s (certificate of analysis) in lieu of worksheet reviews.

ILI update.

We had a lengthy discussion of the ILI and how it relates to the function and mission of the FSS. In addition, we discussed potential topics and formats for the P2 meeting. Below are notes from Michael Flourney who is the FSS representative to the ILI.

“I enjoyed our ILI meetings we had at the annual meeting. I jotted down a couple of concepts that we might consider as activities and or direction, which could possibly develop the mission statement and/or core values. I know we do these things intrinsically but can we get these or other simple (or complex) ideas “on the back of our badges”?

As an ILI board member, we…

Identify and develop thought leaders

Develop education and training program/needs

Strategically plan through industry (ACIL section) ideas

Work with agencies to improve technical advances

Facilitate web-based multimedia learning tools

Utilize workshops for training and forums

Richard used this statement:

ILI – developing education, training, products and other services that benefit the independent testing laboratory community.

I think if we do a great marketing job, we can use the word “Incubator” as the hook, understanding the “New Technology Incubator” concept we can probably expand this to describe what we do.

ILI – Incubating growth through education, training, product improvement and efficiencies that benefit the independent testing laboratory community.

Somehow we can use the word “Incubator” as the concept to always be our guiding light to our purpose! These were just my back of the napkin ideas…”

Some additional ideas were

-Stay alert to other significant scientific/laboratory meetings when scheduling the P2, i.e. PITTCON.

-Consider round table discussions of issues with the regulators or just ACIL members.

-Method roundtables (mycotoxins, QuCHERS)

-Workshop on detention packages with the FDA.

Top 10 Non-Conformity Issues for Testing Labs

Kelley Feist (ACLASS) provide a presentation on non-conformity issues from three AB’s. Attached are the power point slides for the presentation.

ACIL Value Proposition

Jeff Abels discussed the new draft of the ACIL value proposition. Each section has been asked to tailor it for their particular group. This document will attempt to clearly define the value that ACIL provides to its members which will be useful in discussions with non member labs. The attendees were encouraged to review and make suggestions based on their experiences with ACIL.

Updates

Jeff provided brief updates on the

1.On going efforts to secure lobbying consultants,

2. Status of the response to FDA for information on the economic impact on private labs of the accreditation regulations under FSMA and

3. Request for comment on an FDA/CFIA document concerning the reliance of regulators to use specific international standards.

9.0A.O.B

No additional business discussed at this time.

10.0Next Conference Call:

Oct. 16, 2013; 3:00 p.m. EDT

11.0Adjournment:

5 pm PST

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FSS ExCo Minutes 071713