I like pistachios: 11 sick with Salmonella so FDA get stern

Below are excerpts from a warning letter to Stewart Resnick, owner, The Wonderful Company based in Los Angeles, Calif., from the U.S. Food and Drug Administration.

salm-pistachiosDear Mr. Resnick:

From March 8th through April 7th, 2016, investigators from the United States Food and Drug Administration (FDA) conducted an inspection of your pistachio manufacturing process at your facility located at 13646 Highway 33, Lost Hills, CA 93249. The inspection was conducted in response to a multi-state outbreak of 11 human infections with Salmonella Montevideo (9 cases) and Salmonella Senftenberg (2 cases)) in nine states. Based on traceback and epidemiological evidence taken together with inspectional evidence, we have concluded that pistachio nuts produced by your firm are adulterated within the meaning of 21 U.S.C. 342(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(1)] in that they bear or contain Salmonella, a deleterious substance which may render them injurious to health, and within the meaning of 21 U.S.C. 342(a)(4) of the Act [21 U.S.C. § 342(a)(4)], in that they were prepared, packed, and held under insanitary conditions whereby they may have been rendered injurious to health.

Our investigators’ observations were noted on Form FDA-483, Inspectional Observations, which our investigators issued to you at the conclusion of the inspection. You may find a copy of the Act and the regulations promulgated under the Act by following links at www.fda.gov.

Based on collaborative epidemiological and investigational efforts between the FDA, CDC, and the California Department of Public Health, we conclude that pistachio nuts produced by Wonderful Pistachios & Almonds, LLC were linked to this outbreak of Salmonella infections. Ten of the eleven individuals infected with Salmonella were available for interview, and eight of the ten (80 percent) reported eating pistachios during the week before illnesses onset, five of whom reported eating Wonderful brand pistachios. By comparison, a review of data from the 2006-2007 FoodNet Population Survey, which provides information about food consumption among the general population, suggests that only 12% of consumers would have been expected to consume pistachios in a weeklong period. CDC evaluated the probability of case-patients reporting this exposure among a sample of 10 persons and found significance when four or more case-patients report the exposure. No other food specific food was identified as a suspect vehicle.

trader-joes_-pistachiosAfter reviewing the epidemiological evidence, we inspected your facility and collected three product samples at your firm, each consisting of 30 subsamples. Five of 30 subsamples of one sample of raw in-shell pistachios we collected from your silos yielded four positive tests for Salmonella Senftenberg and one for Salmonella Liverpool. Whole genome sequencing determined that the Salmonella Senftenberg isolates were nearly identical to isolates from case patients involved in the outbreak. The most probable number in these subsamples ranged from less than 3 to 23 Salmonella cells/gram.

We acknowledge that you recalled product in response to this outbreak.

We acknowledge your written response to the Form FDA-483, dated April 19, 2016. In your response you proposed to study the optimal level of chlorine in the (b)(4) tank and to install a (b)(4) system to remove foreign material prior to conveying the pistachios into storage. However, you did not provide us with documentation demonstrating the effectiveness of these changes and any other changes you have made to prevent a reoccurrence of an outbreak.

This letter is not intended to be an all-inclusive list of violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including the CGMP regulations for food. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

You should take prompt action to correct the violations noted in this letter. Failure to promptly correct these violations may result in enforcement action by FDA without further notice, including, without limitation, seizure and/or injunction.

You should respond in writing within 15 working days of receipt of this letter describing the specific steps you have taken to correct the noted violations and to prevent these violations or other similar violations from occurring again. In your response, include documentation, including photographs, corrective actions you have taken to date, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 working days, please state the reason for the delay and include a timetable for implementation of those corrections.

Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility.  The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the FFD&C Act.  Accordingly, FDA may assess fees to cover any reinspection-related costs.

Safety and Salmonella in pistachios

New International Association for Food Protection president, committee member for my PhD and all-round nice person (who won’t be put in the corner), Linda Harris, leads a new paper reviewing the safety of in-shell pistachios.

pistachiosAfter harvest, pistachios are hulled with mechanical abrasion and then separated in a float tank containing water; the nuts that float (∼15%; floaters) and those that sink (∼85%; sinkers) are dried and stored separately. To determine the prevalence of Salmonella in pistachios, a total of 3,966 samples (1,032 floaters and 2,934 sinkers) were collected within 4 months of the 2010, 2011, and 2012 harvests from storage silos (12 samples from each silo, in most cases) and were stored at 4°C; 100-g subsamples were enriched for the presence of Salmonella.

Twenty-one of the floater samples and 11 of the sinker samples were positive forSalmonella: 2.0% prevalence (95% confidence interval [CI], 1.3 to 3.1%) and 0.37% prevalence (95% CI, 0.21 to 0.67%), respectively, for a weighted average prevalence of 0.61%. Levels of Salmonella were determined for positive samples using a most-probable-number (MPN) method with multiple 50-g, three 5.6-g, and three 0.56-g subsamples. Geometric mean levels of Salmonella in floaters and sinkers were 0.66 MPN/100 g (0.14 to 5.3 MPN/100 g) and 0.18 MPN/100 g (0.10 to 0.62 MPN/100 g), respectively. Seven different serovars were identified among the isolates, with nine pulsed-field gel electrophoresis fingerprints; as many as four serovars were isolated from some samples. Salmonella serovars Montevideo (44%), Enteritidis (19%), Senftenberg (16%), Worthington (12%), and Liverpool (9.4%) were most commonly isolated from the initial 100-g samples.

The prevalence and levels of Salmonella in pistachios are within those observed for other tree nuts, but the limited number of serovars isolated suggests a narrow and persistent contamination source.

Prevalence and amounts of Salmonella found on raw California inshell pistachios

Harris, Linda J.1; Lieberman, Vanessa2; Mashiana, Rupinder P.2; Atwill, Edward3; Yang, Mai4; Chandler, Jeffrey C.5; Bisha, Bledar6; Jones, Thomas4

1: Department of Food Science and Technology, Western Center for Food Safety, University of California, Davis, One Shields Avenue, Davis, California 95616, USA;, Email: ljharris@ucdavis.edu 2: Department of Food Science and Technology, University of California, Davis, One Shields Avenue, Davis, California 95616, USA 3: Western Center for Food Safety, Department of Population, Health, and Reproductive Medicine, University of California, Davis, One Shields Avenue, Davis, California 95616, USA 4: DFA of California, 1855 South Van Ness Avenue, Fresno, California 93721, USA 5: Department of Animal Science, University of Wyoming, 1000 East University Avenue, Laramie, Wyoming 82071, USA, Department of Agriculture, National Wildlife Research Center, 4101 LaPorte Avenue, Fort Collins, CO 80521, USA 6:Department of Animal Science, University of Wyoming, 1000 East University Avenue, Laramie, Wyoming 82071, USA

Journal of Food Protection, August 2016, Number 8, Pages 1304-1315, DOI: http://dx.doi.org/10.4315/0362-028X.JFP-16-054


Nuts to you again: American Gourmet Pistachios recalled for Salmonella

American Gourmet of Vista, CA is recalling American Gourmet Roasted/Salted Pistachios because they may be contaminated with Salmonella.

salm.pistachio.16American Gourmet was informed by its Pistachio supplier to initiate a voluntary recall. 

The products, which were distributed in San Diego, Riverside, and San Bernardino counties in the state of California through retail stores and can only be identified by Best by Dates found on the lower bottom panel of the package.

Name: Roasted and Salted Pistachios  

Size:    2.5 oz  4 oz     7.5 oz

Best By:          11.5.2016 through 1.13.2017           11.5.2016 through 1.13.2017           11.5.2016 through 1.13.2017

UPC Code:    1578600108    1578600135    1578600123

No illnesses have been reported to date.

Salmonella in pistachios triggers recall

Lipari Foods, LLC, of Warren, Michigan, has issued a voluntary recall of various raw pistachio products packaged by sister company JLM due to potential Salmonella risk.

pistachioThe products were distributed to food service and retail stores throughout Iowa, Illinois, Indiana, Kentucky, Michigan, Minnesota, Missouri, Nebraska, Nevada, Ohio, Pennsylvania, Tennessee, Wisconsin and West Virginia.

Products were distributed under the following brand names: Blue Goose Market, Hollywood Market, Market Fresh Fine Foods, Roger’s Foodland, Marv & Alison’s Marketplace, Long Lake Market, Martin’s, Holiday Market, The Purple Onion, Trentwood Farms, Angeli Foods, Market Square, Village Food Market, Martha’s Vineyard, Remke Market or as generic product without branding.

There are no reported illnesses in connection with these products to date.

This was brought to our attention by our supplier, International Foodsource, LLC who recalled raw pistachios after testing performed by an FDA contract testing laboratory revealed the presence of Salmonella. As a precaution, Lipari Foods products are being recalled as they have the potential to be contaminated due to the fact that they were packed from an affected lot that was received from International Foodsource, LLC.

Food safety, one pistachio at a time

Pistachio growers probably won’t agree, but the New York Times says in an editorial this morning that  the recent blanket warning from the Food and Drug Administration about salmonella in pistachios was one of the most encouraging events in years and sent a powerful signal to those in the food business that the F.D.A. planned to focus more urgently on the safety of consumers.

The editorial concludes that even though the Obama F.D.A. appears to be doing a better job, Congress needs to beef up the agency’s staff and broaden its recall authority. Longer term, Congress and the White House need to keep promises to take a deeper look at food safety. It is time to think seriously about establishing one federal agency to coordinate and enforce food-safety regulations — and give consumers the protections they need and deserve.

FDA takes action on Salmonella in pistachios

Salmonella has been detected in two of the 200 environmental tests of the California processing plant operated by Setton Pistachio of Terra Bella, Inc. that has already recalled 2 million pounds of potentially contaminated pistachios, the New York Times reported yesterday.

Additionally, a joint inspection of Setton’s plant by the FDA and the California Department of Public Health found that Setton employees often used the same transport bins, conveyors and packing machines for both raw and roasted pistachios. Kraft suggested last week—after issuing their own recall—that cross-contamination between raw and roasted nuts could have been the issue.

On Monday Setton expanded its recall to include all lots of roasted in-shell pistachios and roasted shelled pistachios that were produced from nuts harvested in 2008.

FDA officials told the NY Times that the agency’s interim head, Dr. Joshua Sharfstein, hoped to avoid some of the problems associated with the ongoing Peanut Corp. recalls and started conference calls over the weekend with as many as 40 agency officials conversing about the appropriate next steps.

“The food industry needs to be on notice that FDA is going to be much more proactive and move things far faster,” said Dr. David Acheson, associate commissioner for foods at the Food and Drug Administration. “We’re going to try to stop people from getting sick in the first place, as opposed to waiting until we have illness and death before we take action.”

That, of course, sounds like an excellent plan.

Swift action, though, means taking some broad precautionary steps that many in the pistachio industry have already expressed concern over. They don’t want the mistakes of one company to reflect badly on all of them. FDA, impressively, is trying to be mindful of that and is pointing interested consumers to a list industry organizations have constructed of products that are not linked to the Setton recall.

This proactive mindset, coupled with attention to industry concerns, is actually reminiscent of the FDA’s approach to the Salmonella Saintpaul outbreak last summer. But no one appreciated it then.

If the FDA can continue to dialogue with members of the food industry—including whistle-blowers like Kraft and concerned pistachio growers—and clearly communicate its plans to consumers, it may have a terrific shot at salvaging its reputation as an agency committed to the health of consumers and supportive of the success of food producers with the same commitment.

It might also be able to reduce the number of people that get sick from food. That would be most appreciated.

Salmonella in pistachios: He Said, She Said

It’s on, bitches.

After a production manager for Setton Pistachio’s sister company in New York said yesterday Kraft Foods did not tell Setton until recently that they had detected salmonella-tainted pistachios last year, Kraft offered a timeline of Salmonella-positive events. Kraft spokeswoman Susan Davison said,

Workers at one of Kraft’s manufacturers in Illinois turned up a contaminated batch of fruits and nuts in December 2007. Then, in September of last year, another positive sample appeared.

Only after thousands of tests could the company pinpoint the source for the second positive test as California-based Setton Pistachio of Terra Bella, Inc. … Kraft finally determined pistachios caused last year’s problem in March, when their manufacturer in Illinois detected salmonella for the third time – this time in the nuts, the only common ingredient between the second and third batch of trail mix. Kraft has not traced the source for the first positive salmonella test in 2007.

"If we did detect salmonella, of course we would never ship our products. We conducted extensive testing of all our food, and we were just unable to zero in until March that pistachios were the root cause."

Setton Pistachio then retracted the production manager’s statement.

On Friday, the Food and Drug Administration sent out a letter to the pistachio industry reminding nut processors to follow good manufacturing practices to protect consumers, something food safety experts called welcome guidance.

Oh, and before it was an Ashley Tisdale song, He Said She Said was a bad 1991 romantic comedy about competing newspaper advice columnists. They’d be blogging for free today.

Pistachios had tested positive for salmonella for months

Every time the U.S. Food and Drug Administration issues a public advisory about some food product, the armchair critics pounce.

This time it’s pistachios. On March 30, FDA issued a blanket warning for folks not to eat pistachios or products containing pistachios until further details emerged. The nut industry went … nuts. Perishable Pundit Jim Prevor did his bit about how regulators and others could be sure the contamination went back to the pistachio plant. Several journalists asked me about the economic burden of such a recall, especially since there were no confirmed illnesses. I told CBS Radio that if industry wanted an economically prudent plan, industry should keep Salmonella out of pistachios.

The other aspect is that, given the public and government scrutiny of FDA, there is probably something going on – something is not quite right at the farm or processing plant or wherever – for FDA to issue a blanket warning. FDA just doesn’t have all the details yet.

Here are some details:

Elizabeth Weise of USA Today is reporting this morning that Setton Pistachio, the company that recalled 2 million pounds of pistachios on Monday, had been receiving positive salmonella tests for as long as five months.

David Acheson, FDA associate commissioner, said,

"The question is, ‘Did Setton Farms have an ongoing problem, and what did they do about it?’ "

The FDA believes batches of pistachios that tested positive for salmonella were destroyed, not distributed. Setton Pistachio spokeswoman Fabia D’Arienzo could not confirm that.

Almond Princess Linda Harris, an expert on salmonella in nuts at the University of California-Davis, said,

"If I’m getting a positive (result) and a couple of months later another positive, and then another, I would think the appropriate response would be to say, ‘This is not right. I’ve got to figure this out.’ "

Kraft spokeswoman Susan Davison said Kraft sent an internal food-safety auditing team to Setton Farms’ Terra Bella plant on March 23 and,

"They saw the potential for cross-contamination" between raw and processed pistachios. “For example, often in companies different colored gloves are used for the raw area and the roasted area." However at the Setton plant, the same colored gloves were used in both areas.

Kraft unit recalls Salmonella-tainted trail mix; it’s the pistachios

Back to Nature Foods Co., a Wisconsin firm owned by Kraft Foods Inc., issued a nationwide recall Wednesday on its Nantucket Blend trail mix because some of the pistachio nuts tested positive for Salmonella.

And the pistachios came from a supplier to the Georgia Nut Company, which found the Salmonella through its own testing.

The press release from the U.S. Food and Drug Administration said,

This possible contamination is not connected with the recent outbreak associated with peanuts or peanut butter and no cases of Salmonellosis have been reported in connection with the recall.

Back to Nature Foods products are sold in Chicago area Dominick’s, Jewel, Target, Wal-mart, Whole Foods, Wild Oats, Hy-Vee, Kroger, Meijer and Woodman’s stores, as well as at military commissaries.

Casey did a quick search and found there have been no Salmonella outbreaks or reported positives associated with pistachios, although 2006 Good Agricultural Practice documents suggest limiting exposure of pistachios to irrigation water and carefully handling on-farm manure because of the possibility of microbial contaminants. It appears there’s a widespread belief that the hull protects the edible parts, and drying and roasting further mitigate risks of contamination, although the GAP document and research on other nuts has concluded such assumptions remain unverified.