1st Face to Face meeting!

Meeting Report: AOAC 2007
Sept 16-20, Anaheim, CA

Dear Veterinary Drugs Subgroup,

Listed below is a summary of our Subgroup activities since our meeting in September:

1. Created a mailing list of interested parties--about 40 people, though I think some of the email addresses that I have are still not correct.

2. Sent out an email to this list about prioritization criteria, methods needed, and volunteer interests.

3. So far, only Sherri Turnipseed, FDA/ORA/ADRC, has expressed interest in being a "voting member" of the sub-community. Valerie Reeves, FDA/CVM/ONADE, said she would help review.

4. We do seem to have a general consensus on criteria for prioritizing methods. I originally proposed:

Veterinary Drug Residue Method Needs!

Two of the respondents also sent back excel file with proposed methods.
I am attaching the merged file showing method needs expressed by the group.

I hope the sub-community will review the file and add to it.

Prioritization criterion for veterinary drug residue methods

Discussion:

1. Health risk 50
Trade disruption 30
Technology update 10
Improves lab efficiency 30
Method is ready for collab. validation 30
Labs are available for collab. val. 40

Comments that came back were (in no particular order):

2. I think the priority weightings are pretty good. I would maybe give less emphasis to trade disruption and even more to health risk. Also- maybe you could include a factor for "expands number of analytes monitored" to reflect and evaluate the newer multi-class, multi-residue methods.

3. As far as the weighting of the methods I would increase health risk to the highest after increasing trade disruption above the others, say trade 50 and health 80. Since AOAC is international, and we don't have any current import tolerances I think trade could be an important area for AOAC to work in.

Prioritization criterion Weight
Health risk 50
Trade disruption 10
Technology update 20
Improves lab reliability & efficiency 30
Method is ready for collab. validation 20
Labs are available for collab. val. 40

4. In terms of the prioritization criterion I would add the following:

1. Regulatory significance
a. Health risks
b. Availability of established tolerance levels or levels to be determined.
c. Amount of testing to be required, i.e. exploratory, surveys or a required certificate for every shipment.
2. Trade issues
3. Method availability and validation
In general, a determinative method should exist for every analyte of concern and when there is a need for a larger amount of testing then a rapid screening method should be developed with the potential to confirm by the determinative method.

As you can see, there is some disagreement, but everyone puts health risks at the top. I personally agree with the person who pointed out that AOAC may have more stake in validation of methods that can somehow ameliorate (is that the right word?) trade disruption, even if that may not be of the most concern to some of us government types. The existence of a fixed target--whether tolerance, MRL, or MRPL--certainly makes it easier to know if you have achieved your goal, so I will add that criterion. However, I don't know that I will give it a high weighting factor, since so often we must work in a murky area where no one in authority will commit to a fixed target concentration.

Conclusion:

So a merged set of criteria looks like (in order of importance):

Health risk 60 (increased)
Labs are available for collab. val. 40 (unchanged)
Trade disruption 30 (unchanged)
Improves lab reliability & efficiency 30 (modified)
Method is ready for collab. validation 25 (slight decrease)
Technology update 15 (slight increase)
Availability of established target conc. 15 (new)

So, that pretty much constitutes my report. For those of you on the blind cc (which is most of you), I would like to know whether you want you email shared out amongst the group. If I don't hear "yes" from most of the people on the mailing list, I will continue to use a blind cc, since I don't wish to broadcast anyone's email address without their permission.

We are also not including e-mail contact information for members on the website. If you don't mind sharing this information via the web, we may update our lists at a later date.

Mary Carson

Please forward comments to John Reuther at jreuther@centralanalytical.com