FDA’s Pistachio ‘Warning’: The Other Side Of The Story

Source of Article:  http://www.perishablepundit.com/#4

July 1, 2009

 

Although our coverage of the recent issues with pistachios and salmonella has been extensive, we haven’t felt it necessary to mention every one of the now 664 recalls, though these continue to drip-in as various repackers continue to announce recalls. Then, for the first time in memory, we received a “warning” notice from the FDA advising that consumers not eat the product of a specific company:

FDA WARNS CONSUMERS NOT TO EAT CALIFORNIA PRIME PRODUCE AND ORANGE COUNTY ORCHARDS BRANDS OF PISTACHIOS
Products linked to the previous recall by
Setton Pistachio of Terra Bella Inc.

The U.S. Food and Drug Administration is warning consumers not to eat California Prime Produce and Orange County Orchards brands of pistachios repacked by Orca Distribution West Inc., Anaheim, California, Orca received and repacked pistachios recalled by Setton Pistachio of Terra Bella Inc., Terra Bella, Calif.

The pistachios may 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 Salmonella 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 (infected aneurysms), endocarditis and arthritis.

The FDA visited Orca as part of its audit checks to follow up on Setton Pistachio’s recall. The FDA found that products subject to Setton Pistachio’s recall had been repacked and distributed by Orca under the California Prime Produce and Orange County Orchards brands. Orca has not made a public announcement regarding these products. Therefore, the FDA is issuing this press release to alert consumers so that they can take appropriate action.

The products were distributed to retail locations in airports and hotels nationwide. The California Prime Produce and Orange County Orchards brands of pistachios were packaged in clear 6 ounce flexible plastic Ziploc bags, UPC Number: 8 10826 01116 2 with Sell By Dates of 7/30/09 and 8/30/09.

Consumers who have purchased these products are urged not to eat them. They can also report problems, including adverse reactions, to the FDA district office consumer complaint coordinator in their area of the country.

To date, more than 660 product entries have been included in the FDA’s list of recalled products because of their association with the recall by Setton Pistachio of Terra Bella Inc. For the most updated list of all the recalled products and pistachio products not subject to the recall, please visit: http://www.fda.gov/Safety/Recalls/MajorProductRecalls/ Pistachio/default.htm

Basically, this appeared to be one of the rare cases in which a company was refusing to issue a recall despite FDA pressure. It is such a rare occurrence that we asked Pundit Investigator and Special Projects Editor Mira Slott to find out more:

Jan Caselli
Owner
Orca Distribution West
Anaheim, California

Q: FDA said it released a warning to consumers not to eat California Prime Produce and Orange County Orchards pistachio brands because Orca did not comply with its request to do so. Is this correct, and if so, why did you choose not to issue a consumer alert?

A: This consumer warning was totally vindictive on FDA’s part. We have been vilified by FDA. The FDA press release is erroneously worded to make it appear that Orca did not comply with FDA. I don’t have any recourse. I could hire the best attorney and nothing will change. We are wholesale distributors, and on April 6, I got notified from one of my suppliers, Specialty Commodities, that Orca received 50 pounds of Setton product in January and another 100 pounds in February that could have been contaminated with Salmonella.

It came to our supplier’s attention in their audit with the FDA. At that point, I did my own audit and learned a total of 340 bags were produced from those lot numbers. I immediately contacted our accounts that we sent this product to and they did a full blown recall at the retail level. In fact we not only recalled the 340 bags we believed contained the Setton product but, in an abundance of caution, we recalled all our pistachios that had a sell by date of 8/09 or 9/09 even though many of these came from other sources unrelated to Setton. This was a voluntary recall and still remains that way. I’ve had no reported incidents of illness nor have my customers.

At the end of April, FDA contacted me because they had been given a customer list from Specialty Commodities. I gave my customer list to FDA as they requested. FDA asked me to do a press release and I explained that my customers pulled everything from the shelves. I replaced the recalled product with new product at my own expense. Mind you, I didn’t know the exact origins of those 340 bags in question.

Q: Why not? Don’t you keep records?

A: I place a master order for pistachios from my supplier. I pulled every pistachio from that time frame. FDA implied I intentionally repacked contaminated pistachios. When I sent out product in January and February, I didn’t even know there was a problem. I was only notified from my supplier in April.

Q: Wouldn’t there have been a possibility that some of the products from your shipments could have ended up in consumer homes? Did your customers catch the products early enough in the process where consumers wouldn’t have had a chance to buy them?

A: To clarify, once my supplier, Specialty Commodities, notified me that I had received 150 pounds of Setton product, I notified my customers to pull all product with the sell-by date of 8/09 or 9/09 as those could have contained Setton pistachios. The small amount of Setton product we had received from our supplier was in that period.

Q: What percentage of your pistachios during that period came from Setton?

A: I had received other types of pistachios, not just from Setton. I have another supplier, Garvey Nut & Candy, that does not buy from Setton… ever. I gave FDA information on all orders that had pistachios and all the ones we recalled. There were pistachios that I didn’t need to recall, another 75 pounds I purchased in January and February in addition to that 150 pounds from Setton.

Garvey Nut & Candy has dealt with the FDA on this issue and assured me I did not receive product from them related to the recall. I pulled everything on the shelf with those sell-by dates regardless.

We use a six-month shelf life on our packages. We took no chances on whose product they may have received, so I instructed them to pull all pistachios shipped during that period. I instructed them to destroy and give me a count of product on hand and we did replacement. My audit says there were a few bags purchased.

Q: For perspective, how many bags did consumers purchase before product was pulled from the shelves? Not to belabor the point, but before this FDA consumer release, how would consumers, who may have purchased product from those January/February shipments, learn that these products were involved in a recall? How many consumers could have been at risk of eating contaminated product?

A: Out of the 340 bags shipped, our records document we recalled and destroyed 272. Potentially there could have been 68, six-ounce bags floating around out there. This is the basis for all the hype. We have no reported incidences of illness. I’m all for protecting our consumers… my God, I’m in a business where it’s so important to me.

Q: Isn’t it also relevant where these bags were sold and the fact they were travel-size, snacking portions, rather than large packages that might be stored for extended periods in a kitchen pantry? In other words, would it be possible or even likely, especially at this juncture, that any bags unaccounted for in the recall have already been consumed?

A: These are single portion, six-ounce bags. They are sold in hotel lobby shops and airport gift shops in individual serving size. If you had a bag in the pantry, you’d throw it away, but these are the kinds of bags that would be consumed right away. These items would not likely be brought home and stored for future consumption. These products are carried in travel gift shops. They are in one airport, Palm Springs airport, and the rest are hotel lobby gift shops. I handled things correctly, especially in this context.

By the way, FDA said “various airports”, when it was only one. People were looking at other airports to see if my products were there.

Here’s little Orca, and they used pictures showing pallets of Setton product. It doesn’t make any sense at all. They showed the boxes, which had nothing to do with our product. That doesn’t help the consumer. We’re wholesalers. When we buy Setton product, we put it in our own package. Consumers don’t see the Setton brand on a retail shelf, they see our brand.

Q: Earlier you pointed out that the pistachio recall was voluntary. Yet, many companies say they feel compelled to abide by FDA’s recommendations for fear of retribution. Are you claiming that FDA’s June 22 news release warning consumers not to eat your brands of pistachios was only done to punish you?

A: I’ve been maligned by the FDA because I said I didn’t know what good it would do to issue a press release. I was cooperative. It’s not like I refused in a belligerent way; I just didn’t see the value in it. What chance would there be of someone having the equivalent of four handfuls of pistachios from January or February? FDA’s actions were way overkill. I was shocked when FDA put out that release.

Of course, if it’s one bag or 1,000 bags that could be tainted, it’s just as important to take action, but it seemed too long in the stream of things to issue a consumer warning that would have any benefit. If this had anything to do with saving someone’s life, I wouldn’t hesitate to do a press release.

Q: When you asked your customers to destroy product, did you get a dump certificate or another type of official receipt to verify they actually did it?

A: I didn’t get a dump certificate, but I did get a dump list.

Q: The Western Pistachio Association (WPA) was quick to disassociate itself from your company by releasing its own statement June 23 following FDA’s press release: “This is not a new recall. Rather, it is an announcement due to a company that apparently did not comply with the FDA’s original recall requirements…The WPA does not condone any entity that knowingly shipped recalled product or withheld information related to the product recalls…” How do you reply to this?

A: I’d like you to make it obvious I did not knowingly repack contaminated product. I learned two months after it had been shipped. The source of the pistachios depends on the supplier I use. One of my suppliers doesn’t even buy from Setton. In those two months -- January and February — I had received product from Specialty Commodities, and Setton is who they were buying from at the time. They ship me whatever product they have in the warehouse and I don’t care where it originated because I have confidence in my suppliers that I’m getting quality products.

Q: What you receive is not labeled delineating the product’s origins?

A: I receive bulk product from Specialty Commodities, which purchased it from Setton Pistachio. It doesn’t even say Setton on the labeling. By the time Specialty notified me that they had shipped me that product, it was April.

Q: Why the big time lapse from that time forward? FDA didn’t issue its press release warning consumers about your brands until June 22.

A: My customers are supporting me. They saw these reports and starting calling me asking, is this something new? And I said no. I feel like FDA is using me to put out another big blurb disparaging Setton. There had to be another agenda because this action wasn’t done for public health. The implications are nowhere near the facts. I have customers that can stand behind that. These are very large companies that don’t mess around. We don’t use pistachios in any other form except in shell; not in our mixes. There are other major suppliers that utilize Setton pistachios as an ingredient in a wide range of products.

The fact is that FDA didn’t contact me until April 21, and the day they came, I started turning over records. When they came to my door, it was the first time I heard from them. I had all the supporting documents, recall letters and evidence of the replacement shipments. I had already done my business with the pistachio recall and I thought this was all in the past.

I have a cover letter stamped May 20, 2009, from Alonza Cruse, District Director, FDA, that states they’ve completed their investigation and the agency concludes the inspection from April 21 closed under Title 21.

Q: What changed since that time?

A: On June 12, a Friday, the Los Angeles County investigator from FDA with the title of Consumer Safety Officer came back to my facility demanding more information. I was not there at the time. My employees said she barged her way in here to the packing room and demanded employees speak with her. She made them nervous.

My manager took her on a tour of the facilities. According to him, she said that our facility was immaculate and she couldn’t find anything wrong with it, but that’s not why she was there. My employees totally cooperated. She told me she interviewed my manager who said he didn’t have any science background.

I was actually out of the Los Angeles area, but my employees called me to let me know she was there. I asked her, what is the nature of your visit? I thought they were done with the investigation. She said they’ve expanded the recall, and your employees don’t have access to the records I need. I said my customers didn’t inform me of that, but I would fax her all the information she wanted, and she made an appointment for the following Monday (June 15) to meet with me at 1 pm. I pulled all the records and faxed them to her.

A series of unfortunate events followed. Apparently, she called on Saturday to change the time of our meeting to 10 am on Monday. She received everything from me on Friday night, and decided she’d just come earlier instead. I didn’t get the message because I was in the desert at the hospital because my father had a heart attack.

That Monday, I got a call from my employee that she arrived at 10 am. He put her on the phone and I said, I thought our appointment was for 1 pm. I can’t get there for a few hours because of the situation with my father, but she insisted, we have to do the meeting now.

She decided she wanted my customer list of anyone receiving product from September, 2008, to date. I explained that my supplier told me I didn’t receive any of those products until January 2009. It didn’t make sense. I wasn’t buying product from Setton in September 2008. I only got Setton product in small amounts in January and February of 2009.

Q: I’m so sorry to hear the news about your father… This must have been particularly trying while you were going through such personal trauma.

A: Thank you for your concern. My father is 82, and the surgery was complicated and painful but he survived it. It’s a miracle.

My conversations with the FDA consumer safety officer were frustrating to say the least. She seemed to be a young woman, although she said she’d been with FDA six years. She couldn’t answer even the most basic questions. When I tried to get clarification, she was curt: FDA isn’t obligated to tell you anything, she said.

She also intimidated my employees. At one point she entered the building at lunch time so most employees were out because the operation shuts down from 12 to 1. She took one of my Hispanic workers, having his lunch with another employee, out of his break. He was insulted. She ordered him to show her around the facility, that she had already visited at another time and grilled him about our customers and pistachios, none of which he is savvy to because he is a packer.

Then she pressured him into signing a document, which looked very legal in type, swearing to his statements. The employee phoned me, concerned about this. He put her on the phone. I asked her not to involve my employees. I would meet with her another day. She told me she had a right to be there and to conduct her business however she wanted.

Q: Doesn’t FDA have certain limitations on its legal authority during investigations?

A: My attorney, who deals in FDA cases, said FDA has the right to come into my facility anytime to investigate, but doesn’t have the authority to take workers off of their lunch break and require them to give a tour. And FDA does not have the authority to take photos without my permission, and I asked them not to.

I tried to protect my employees’ and customers’ privacy. She wanted private cell phone numbers and I didn’t think that was necessary. I had already provided her with sufficient contact information for the customers who got product. My customers told me another FDA representative contacted them and supported the fact I did exactly what I was supposed to do.

Q: Media across the country picked up on this story, questioning your company for withholding information from the public about possibly tainted product. Reports also suggested that you consciously sent recalled product that could have been contaminated into the marketplace. What impact is this having on your reputation?

A: After the news broke, Fox 11, Channel 4, Channel 7, and other media were staked out at my facility here at 7 in the morning. I came in at 8, showing the Fox 11 reporter all my supporting recall documents and my complete customer list, explaining that FDA had contacted them. She told the studio to correct the earlier coverage; that this was not a new recall, and that I never shipped Setton product since early this year.

Local news people were saying to me they were appalled by how my company had been presented, but unfortunately they were not rushing out to air the rebuttal interview. Fox 11 came back at 10 am to do another interview. I had them film in the factory, and they did show it that night, commenting that it had to do with the earlier recall and how we handled it.

The initial negative story got so much hype that it didn’t seem to matter. My Fox LA just continued to have the original bad news story on — the one they got at 7 in the morning when they didn’t have a chance to get comments from Orca. Later that day, at 8:30 in the morning, Fox 11 did air my interview, which vindicated me. The studio reporter told viewers, you can go eat your pistachios now. But the other stations were just airing the original inaccurate 7 am report. I understand the bad report was repeated again on the next day’s news cycle and had continued to remain on the websites.

At this point, I’m not sure how much damage this may have caused to my business and reputation. My customers are supportive and believe my brands will be OK.

I sense FDA’s actions were an attempt to prove their power. FDA has been heavily scrutinized for how it has handled food safety, and it wanted to show it was doing something. Even if FDA felt compelled to do a press release, they didn’t have to do it in such an inflammatory way, with a headline that implied that all our product should be avoided whenever it was produced. They took this to the fullest, like they were out to get us. I wonder if this FDA woman had a problem with me because I’m a woman in business and I know what I’m doing. She thought she had the right to intimidate my employees and to treat people however she wanted without any recourse. The way she spoke to me was disrespectful. I’m proud of what I do here. I operate my business with integrity, and I believe FDA’s behavior was absurd.

It is actually a very fascinating story with several key points:

First, on the substance of the matter, Jan Caselli is wrong, particularly when you consider that pistachios are a semi-perishable item that can be kept for an extended period. No matter what she did, no matter what her customers did, as long as even one packet reached consumer hands, there is the possibility that the pistachios are sitting in a purse or a pantry. Pistachios are semi-perishable, not a product like spinach that just rots. These consumers certainly should be informed of known risks — including that these pistachios may be part of the Setton Pistachio recall.

Second, on a food safety basis, Jan Caselli is right: The FDA’s action are absurd. As we mentioned here, the FDA makes the ridiculous assumption that its mere knowledge of a problem with one firm’s production of a product means that this particular product is more dangerous than some competitive product. In fact, discovery of such a pathogen is such a Black Swan Event that its discovery means nothing. You might test that firm’s product for a hundred years and never get another positive or, you might test its competitor’s products and find you receive positives just as frequently or more frequently. In either case, recalls do nothing to enhance food safety.

Add in the fact that this particular repacker sells only small bags at airports and hotel gift shops — so these are not giant bags or jugs that people are likely to keep for extended periods — and the fact that FDA issued its “warning” almost four months after the last of these baggies were shipped and that there are only 68 bags unacounted for and presumed sold and only a portion of the repacker’s pistachios during the period in question came from Setton — and the risk from this repacker’s products is exceedingly small. We must have a safe food supply indeed for FDA to bother with such a small matter. Indeed, next time FDA is crying about its lack of resources, we might remember that it sent staff not once, not twice, but three times to this little repacker who sells six-ounce packages in hotel gift shops. If the FDA uses its resources in this way, the FDA will never have adequate resources.

Third, Jan Caselli’s experience with the FDA field office operation adds to the experience we found with the Honduras Cantaloupe matter that local FDA officials are often tyrants. We have been told by leading experts in epidemiology that many border on incompetent and are unable to understand their own epidemiology, so they seem to fall back on bullying tactics. We have suggested that trade associations consider having epidemiologists and attorneys on retainer so that when confronted with a local FDA official, companies have a competent team pre-assembled to help them.

At very least it points to a neglected portion of crisis management programs most of which start with the food safety crisis — how about the crisis starting when FDA shows up at your door. What to do then?

Fourth, Jan Caselli is quite right about FDA being vindictive. The very headline of its release, “FDA Warns Consumers Not to Eat California Prime Produce and Orange County Orchards Brands of Pistachios,” is very different from the actual message in the release: “The California Prime Produce and Orange County Orchards brands of pistachios were packaged in clear 6 ounce flexible plastic Ziploc bags, UPC Number: 8 10826 01116 2 with Sell By Dates of 7/30/09 and 8/30/09. Consumers who have purchased these products are urged not to eat them.”

Blaring a blanket headline “not to eat” two brands, when the actual advice is very circumscribed, is clearly FDA’s way of saying that companies better obey FDA or FDA will make things much, much worse for the firms that don’t go along..

The problem is, of course, that Congress has, to date at least, specifically elected to not give the FDA the authority to order recalls and FDA’s own regulations state that it will only request a recall in “urgent situations” – a difficult case to make in this situation. The agency can scream “public health” all it wants. The odds that by issuing this warning, several months after the event, someone was saved from salmonella are, for all practical purposes, zero.

FDA seems to view the law and its own regulations as not so much a limitation on its powers but as an inconvenience, and it is prepared to come down hard on anyone who thwarts its will, even if it has no statutory or regulatory authority to act in a particular arena.

If FDA is aware of any product that is adulterated, it has authority to seize such food. Normally, it uses that lever to “persuade” companies to make recalls. In this case, all the product is long gone and there is nothing for FDA to seize.

Still, in America, just because an agency is powerful, it should not use its powers to threaten law-abiding citizens, and Jan Caselli was well within her rights in deciding not to issue a press release. There is something uncomfortable about FDA officials believing their role so important that they are prepared to go around the plain language of the law to find ways to “punish” those who refuse to comply with the desires of the FDA.

Many thanks to Jan Caselli for sharing her story.

 

 

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