Auditor Sued for Damages, for Failure to Warn of Process Risk

M

MIREGMGR

#21
Was this firm an auditing firm or was it a consulting firm?
This regulatory law blog http://www.fdalawblog.net/fda_law_b.../10/jensen-farms-sues-auditor-primuslabs.html seems to say that the Jensen perspective is that the auditor was expected by them to provide advice.

Lay persons might think that an auditor would be there to "make sure that everything was safe" or whatever, but those of us in the regulatory community probably would agree that auditors usually audit for conformance to one or more particular standards or rule-sets, and that what a third party auditor is there to do is (always?) defined as part of their establishing business agreement. I haven't seen anywhere yet a specific statement as to what standard the auditor was auditing to.

It'll be interesting to see if the courts adopt the "auditors make sure that everything is safe" perspective.
 
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T

treesei

#23
This regulatory law blog http://www.fdalawblog.net/fda_law_b.../10/jensen-farms-sues-auditor-primuslabs.html seems to say that the Jensen perspective is that the auditor was expected by them to provide advice.

Lay persons might think that an auditor would be there to "make sure that everything was safe" or whatever, but those of us in the regulatory community probably would agree that auditors usually audit for conformance to one or more particular standards or rule-sets, and that what a third party auditor is there to do is (always?) defined as part of their establishing business agreement. I haven't seen anywhere yet a specific statement as to what standard the auditor was auditing to.

It'll be interesting to see if the courts adopt the "auditors make sure that everything is safe" perspective.
I agree. For example, an auditor would review sterilization validation records against validation procedures and plans etc. to see if they satisfy an ISO standard. However, the auditor usually is not in position to judge whether the validation itself is technically adequate. He is there to check the effectiveness of the quality system not the technical decisions. This melon case may be a little special because it is almost common sense. And if you go deep with the HACCP decision tree, you may find the process inadequate. However, I don't know the details of the audit. Iit would be very interesting to see how the court rules.
 

Wes Bucey

Quite Involved in Discussions
#24
For my part, what's the big deal about washing melons at the farm? I consider the entire supply chain from farm to table in my thinking and can imagine a number of way stations where the outside of melons can pick up contamination, but I don't eat the rind of a cantaloupe. Therefore, cutting the melon introduces the possibility of having the knife blade carry outside contamination into the flesh of the melon.

For the last sixty years or so, I've been washing off the surface of fruits and vegetables right before slicing. I wash the blade of a knife before using it on another food. Any fruit or vegetable can pick up contamination from the environment or from storage and handling anywhere along the supply chain to the table.

Some growing practices introduce higher likelihood of dangerous bacteria (organic fertilizers) or toxins (chemical fertilizers, insecticides) which are not easily washed off with plain water. The end consumer has no way of knowing whether such dangerous contamination has occurred. A reasonable assumption is to prepare food in such a way to reduce the possibility of carrying contamination from the surface to the the part to be consumed.

The fact these farmers are making a plea deal merely means they and their attorneys find it less "risky" to take a negotiated deal than to take an expensive chance on a trial. It does not necessarily mean their method was illegal, only that it was a bad choice in light of subsequent events, since there is no regulation mandating chlorinated rinse in EVERY growing operation. I'm pretty sure my suppliers at the local farmer's market are not washing produce in specially chlorinated water (other than normally chlorinated tap water straight from the faucet or non-chlorinated water straight from their well.)
 
M

MIREGMGR

#25
It does not necessarily mean their method was illegal, only that it was a bad choice in light of subsequent events, since there is no regulation mandating chlorinated rinse in EVERY growing operation.
I'm not an HACCP expert, but my understanding is that for some food operations HACCP is legally required. That of course comes from the difference between the world of standards and the world of FDA.

That, I think, will be a legally and practically important factor in the judicial resolution of the matter at hand.
 
M

MIREGMGR

#26
...the auditor usually is not in position to judge whether the validation itself is technically adequate. He is there to check the effectiveness of the quality system not the technical decisions.
Interestingly, some standards are audited by subject matter experts, specifically so that they are able to judge the technical decisions. ISO 11135-1 (EO sterilization), for instance, normally is audited not just by a "normal" auditor, but also by a qualified microbiologist. It is normal for such microbiologists to get deep into the technical validity of the audited party's understanding and application of the standard's goals and purposes...not just the documentation of conformance to the precise wording in each standard-clause.

In USA, the organization with responsibility for sterilization standards is AAMI. I recently attended a three-day AAMI seminar on industrial EO sterilization--for practitioners, not auditors--at which the three instructors all were microbiologists by training, and about 3/4 of the attendees (typically with full or shared responsibility for their company's sterilization activities) also were microbiologists. It was made very clear during the seminar, for those that didn't already know, that audits in this area were driven by technically proven safety and effectiveness, not solely by the standard.
 
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Wes Bucey

Quite Involved in Discussions
#27
I'm not an HACCP expert, but my understanding is that for some food operations HACCP is legally required. That of course comes from the difference between the world of standards and the world of FDA.

That, I think, will be a legally and practically important factor in the judicial resolution of the matter at hand.
I came across a pdf file from University of California (Davis campus) which describes pre- and post-harvest safety guidelines for produce. This DOES describe "chlorinated" water and monitoring of same for washing. The LINK from which the following excerpt is taken
Use only clean and sanitary field containers.
Continuously monitor chlorine concentrations and pH of hydrocooling or
wash water.

Clean and sanitize field tools. containers and packing lines on a
frequent and scheduled basis.
Clean and sanitize forced air coolers, cold storage rooms and cooler
drain tiles on a frequent and scheduled basis.
Clean and sanitize transport trucks on a frequent and scheduled basis.
Only use cleaning compounds and sar.itizers that are approved for food
contact surfaces.
Use transportation that is dedicated to hauling only produce. Do NOT
use trucks which have been used to transport live animals.
However, these are ONLY "guidelines," NOT "regulations." Perhaps someone can steer us to a regulation and its penalty if not followed which applies to using chlorinated wash water for cleaning produce at the grower (versus in a food establishment which prepares produce for consumption.)
 

Wes Bucey

Quite Involved in Discussions
#29
This FDA document http://www.fda.gov/Food/GuidanceReg...nformation/ProducePlantProducts/ucm278456.htm was published after the cantaloupe incident in question, in response to it, but it contains links to the prior-existing regulations and "guidances" relevant to the matter.
Right! I've seen this, too. My question (and the issue) is not whether there are "guidelines" (lots of those), but whether there is ANY regulation which mandates washing fresh produce with chlorinated water, thus exposing one to either criminal or civil penalty by a government agency when the regulation is not followed. In the absence of the regulation, the imbroglio just becomes one of "personal judgment" in determining whether water needed to be additionally chlorinated and monitored.

In MY judgment, it would be a good idea to use the chlorinated water, but ALSO my inclination to make a point of it in my marketing (like putting "all natural ingredients" on a label) to justify a premium charge to cover the cost in the same way organic produce commands higher price at the market.

Sadly, it all boils down to a mundane "risk assessment" which depends on the personality of the assessor to accept or avoid risk.
 

Jim Wynne

Staff member
Admin
#30
Right! I've seen this, too. My question (and the issue) is not whether there are "guidelines" (lots of those), but whether there is ANY regulation which mandates washing fresh produce with chlorinated water, thus exposing one to either criminal or civil penalty by a government agency when the regulation is not followed. In the absence of the regulation, the imbroglio just becomes one of "personal judgment" in determining whether water needed to be additionally chlorinated and monitored.

In MY judgment, it would be a good idea to use the chlorinated water, but ALSO my inclination to make a point of it in my marketing (like putting "all natural ingredients" on a label) to justify a premium charge to cover the cost in the same way organic produce commands higher price at the market.

Sadly, it all boils down to a mundane "risk assessment" which depends on the personality of the assessor to accept or avoid risk.
I think the criterion needs to be whether or not the produce is contaminated, not whether or how it's washed, unless the washing solution is expected to have an extended antimicrobial effect. Even then, it seems like what was missing was testing for the presence of potentially harmful microbes. The two brothers who ran the farm have been charged with releasing contaminated food into interstate commerce, not with failure to use chlorinated water.
 
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