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Fresh Basil Recall Brings Additional Concerns About FDA’s Safety Procedures

Jim Prevor’s Perishable Pundit, December 21, 2007

As we head into Christmas, here is little gift the industry could have done without:

Top Line Specialty Produce Recalls “Green Paradise”
Basil Because of Possible Health Risk

Contact:
Alberto Martinez
(213) 747-9200

FOR IMMEDIATE RELEASE — December 19, 2007 — Top Line Specialty Produce of Los Angeles, California, is voluntary recalling its 12 x 1 pound boxes of “Green Paradise label” Fresh Italian basil, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with this organism often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with “Salmonella” can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), Endocarditis and arthritis.

The recalled “Green Paradise Basil” was distributed to Food Service Distributors through direct shipping on 12/06/2007 in Southern California, Illinois and Texas.

The product comes in a 12 x 1 lb box marked with lot # 1219 on the side of the box.

No illnesses have been reported to date in connection with this problem.

The potential for contamination was noted after routine testing revealing evidence of Salmonella in some 1lb units of the basil. Imports of this label (“Green Paradise”) have been suspended while FDA and the company continue their investigation as to the source of the problem.

Consumers who have purchased the affected boxes of “Green Paradise Italian Basil” are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-213-747-9200.

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Feeling that our mozzarella, tomato and basil salad with balsamic vinaigrette might be at risk, we asked Pundit Investigator and Special Projects Editor Mira Slott to find out more:

Alberto Martinez
Owner
Top Line Specialty Produce
Los Angeles, California

Q: I hear you’ve been working tirelessly since three in the morning, speaking with customers affected by the recall. I find it admirable that you are devoting your time to personally share more details of your experience with our readers. Following up on the FDA recall notice, could you provide a timeline of events?

A: We sent the press release yesterday afternoon (December 19) and are continuing with the recall process. We printed out a list of customers that we sent product to that day. We’ve been in touch via telephone, but will follow with a formal letter requesting any product they still have in their possession to bring back for a full refund.

Q: How and when did you discover the problem?

A: The product came into the country from Mexico — the southern Baja, California region in the Los Cabos area, on December 5th and to our warehouse on December 6th.

It was randomly tested by the FDA and they notified me when they had the results. I haven’t been provided with any actual test results. They notified me by phone.

Q: What kinds of testing did FDA perform and what did inspectors say were the results of that testing? Were these tests preliminary?

A: I received a letter, a Notice to Importer, from the FDA on December 6th that surveillance sample(s) were collected from the shipment and will be tested for the presence of pathogenic micro-organisms. In the Notice, it said preliminary analytical results may be available within four to nine days following the date of sample collection.

It stated that FDA will attempt to provide us with preliminary results as soon as they become available. I was notified by phone 12 days later. It said in the Notice that should a sample be determined to contain a pathogenic microorganism and is violative, the importer will be responsible to initiate a recall of the product.

Q: Did the FDA confirm the presence of Salmonella in the product it tested?

A: They’re saying it is a possibility, but not providing results. How do I know it’s contaminated? They’re saying over the phone it’s a possibility. On the press release, approved by them, it says the FDA and company will continue to further test. They asked me to do this press release. I e-mailed it to the inspector, they changed a few things and I approved it. The wording is: “The potential for contamination was noted after routine testing revealing evidence of Salmonella in some 1 lb units of the basil.”

Q: How was the scope of the recall determined?

A: I took action to stop further import of this label. FDA didn’t ask me to. I want to assure people we are conscious of safety, and are taking extra steps. I want to clarify this because my name is out there and my reputation is at stake. I told the inspector, ‘I’m a small company, not one of those big, big guys in the industry.’ Even though we received more shipments and they were released from FDA, as an extra precaution we told the shipper not to send any more.

We want to test product on the ground before harvest. We cancelled all shipments from this grower. We have another grower in Puerto Viarta, Mexico, in a different growing region and that’s the product we’re going to be using from now on, until we come to the cause of the problem.

Q: It’s often difficult to get to the root cause of a food safety problem, as exemplified by the spinach E. coli outbreak investigation…

A: We know there’s a possibility we’ll never figure out the cause, but if we test product on the ground and it comes out OK, at least we’re doing our part. I don’t want to get people sick. Hearing about the recall, my wife expressed concern, ‘We’ve been eating basil,’ and I reassured her, ‘Don’t worry; it’s just this one shipment.’

Q: How much product in question went out into the market?

A: 5,500 pounds were received. That shipment was marked with lot number 1219; 12 representing the month, and 19 representing the number of shipments we received from that grower during the season. We import about 20,000 pounds of basil a week. Consumption in the U.S. is huge.

Q: Have you been able to track down all the places the product ended up? Traceability both backward and forward has proven to be a challenge in our industry.

A: I’m the direct importer of this product. My customers are food service distributors, so from that point on I don’t know where the product went. It could have gone to some retailers but I wouldn’t have that information. On December 6th, the product was shipped directly to 13 different distributors located in Southern California, Illinois and Texas.

We’ve been working hard and have been getting tons of phone calls. A lot of people are cool about it. They know what we’re going through and understand the situation, but some don’t have knowledge.

Tracking down product is very hard. It is a highly perishable item that has to be consumed within three to four days. By now, if the consumer hadn’t eaten the basil, they would have thrown it away.

Q: So the delay in notification essentially could have put people’s safety at risk?

A: It’s been two weeks already. The FDA dragged their feet to let us know about it. Now to find out, it’s already too late. The product has already been consumed.

I only spoke to the first inspector in Nogales, Arizona, on Tuesday this week. She told me to call another person in a different location and they gave me another number in San Diego, and then a person there passed on another number for Larry Howell in Irvine, California.

I guess he’s the regional person to go to when product crosses the border. By then, my day was over and everyone had gone home, so I had to wait till the next day. Yesterday (Wednesday, December 19) is when I got in touch with Larry.

Q: There doesn’t seem to be a sense of urgency, even though food safety issues are at stake.

A: These notices from FDA for random testing go out all the time. It didn’t look too concerning to me. Sometimes they red tag product, and you can’t sell it; otherwise there are penalties or fines. That is not what happened here, this was just a random test as far as I know, and we were permitted to sell the product. This has happened before where FDA sends letters, tests randomly and never calls you back to say everything is fine. You’d think they’d call to tell me product is OK. We’re talking over $10,000 worth, which is a lot for a small company. Two weeks later, that product would have been in the trash.

Q: Do you do your own product testing?

A: Our growers do their own testing and provide me with their results, and if we suspect any problem we send product to a lab in Orange County for further testing. During that time, I would hold product, of course. I would always hold product if they had a problem.

Even if FDA would charge us to expedite testing, it would be better to learn about the problem faster. I’d be willing to pay $200, $300, $400 out of my pocket for FDA to overnight samples so we could find out results in two days. Now I have people calling me for my liability insurance certification.

Larry Howell urged me yesterday (Wednesday) to do the press release to let the press know about the potential problem. The second step we’re taking is sending out formal letters to customers that took product. We already talked to our customers by phone.

Q: Have you asked FDA for copies of the results, or documentation in writing of what procedures occurred?

A: FDA won’t even provide any proof the samples were sent to a lab, or the results, and we’ve received nothing in writing, only verbal communication. Unfortunately word spreads of a problem at Top Line Specialty Produce, and it hurts our name. Hopefully people know we are conscious about food safety.

The good thing is this really is a pro forma recall since it is highly unlikely that any of this product is still sitting around. Because most or all of the product went to foodservice, we don’t even have to worry about it sitting in the refrigerators of consumers.

Three things do come to mind regarding this incident:

1)   Why does this take so long? You can practically hear the frustration in Alberto Martinez’s cry:

Even if FDA would charge us to expedite testing, it would be better to learn about the problem faster. I’d be willing to pay $200, $300, $400 out of my pocket for FDA to overnight samples so we could find out results in two days. Now I have people calling me for my liability insurance certification.
2)   Why is the FDA so unwilling to put things in writing, so mysterious about results? We had similar issues when Dole had its issue with the Canadian Food inspection Agency. We asked Why The Secrecy On Inspection Agency Lab Results? And pointed out:

Unfortunately, the CFIA won’t give out any information. They will not share test results or the PFGE strips. They just repeat like a mantra that they took 40 bags, and broke them into 8 samples of 5 bags each.

This is a very serious matter. Reputations, businesses, whole industries can be destroyed based on government reports on these matters.

It is too important a matter to allow for possibly self-serving secrecy.

Both the companies involved and the public at large are entitled to complete transparency so that the possibility of error or malfeasance can be considered.

How do we know that CFIA isn’t covering up for the incompetence of its own lab? Perhaps one day a lab technician will be paid off by a competitor. The process has to be transparent or people will lose confidence.

There is not a reason in the world why CFIA doesn’t release the PFGE strips and the test results so other experts can at least review them for anomalies.

We don’t see any reason the FDA shouldn’t be equally transparent.
3)   The trace-forward issue is still bedeviling the industry. We have an important task force meeting in January. Communication efforts are crucial — we need to get to the point where in the very press release announcing the recall, we can report a lot more information about where the product wound up.

Remember the point is to encourage consumption by being able to reassure people they are safe. So if this product was sold to Pizza Hut by one of the distributors, that info should be out early as should Pizza Hut’s assurance that it has checked every restaurant and none is left. Here we find another step in traceability; a restaurant chain needs a procedure for quick inventory of every restaurant.

We want to come out, virtually simultaneously with a statement: there is a recall on basil, it was sold to Chain A for use in State A, B and C. All restaurants searched and all the product has been consumed or destroyed.

As part of its Produce Safety Action Plan, FDA has been working with industry to develop commodity-specific guidelines for five “high-risk” commodity groups: Cantaloupes, Tomatoes, Lettuce and Leafy Greens, Green Onions and Herbs. This effort began in 2005. Why in the world do we not yet have the plan for herbs? There is, of course, no way to know if it would have helped, but it couldn’t hurt and might do some good.

And it would give someone like Alberto Martinez, who seems like a decent guy who just got run over by a train, something useful to demand of his growers.

Now he is left demanding more testing, not because statistically that will make a difference, but because he feels that “… if we test product on the ground and it comes out OK, at least we’re doing our part. I don’t want to get people sick.”

We should give herb growers a better set of tools so that we can make that more likely. Let us commit to a date certain to finish the Commodity Specific Guidelines for herbs.

Many thanks to Alberto Martinez and Top Line Specialty Produce for taking time in the midst of a pretty tough day to help keep the broader industry informed.

Just as we were putting this to bed we received word of a second, related recall:

We would like to inform you of a Voluntary Recall of 1# Fresh Basil packed under the Bon Apetit brand because they have a potential to be contaminated with Salmonella.

No illnesses have been reported to date in connection with this problem.

The lot# for the 1# Basil involved in the voluntary recall is 52/340.

Following is the specific information:

Product shipped overnight on December 6, 2007

100 — 1# Basil PO#40836

Please call me for any additional information.

Ralph Slomovits
VP Sales & Marketing
HerbThyme Farms, Inc.
310-884-9122 Fax: 637-7218

Apparently HerbThyme Farms had bought some product from Top Line Specialty Produce so this is the exact same product being recalled for the exact same reason. No indication of a larger problem. Many thanks to Ralp Slomovits and HerbThyme Farms for burning the midnight oil to keep the trade informed.

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