Court Upholds FDA Not Negligent in Issuing Warning in 2008 Salmonella Outbreak

The US Court of Appeals upheld the ruling that FDA did not negligently issue a warning about tomatoes contaminated with Salmonella as part of the 2008 Salmonella outbreak. In this case where 1442 people reported illness after eating salsa. FDA initially issued a warning that tomatoes were the likely source, but later it was discovered it was the peppers. Of course, this warning resulted in many tomatoes going unsold as people avoided them. "The court determined that the warning properly fell within the discretionary function exception of the Federal Tort Claims Act and that the district court "ruling was essential to protect FDA's vital role in safeguarding the public food supply."

This case points to the pressure on reporting potential sources of contamination versus the economic impact of a misdiagnosis of the real source. In this case, the tomato industry last millions of dollars. The impact of newer technologies, specifically whole genome sequencing, will benefit these types of investigations.

Penn State Law - The Agricultural Law Brief
https://pennstatelaw.psu.edu/academics/research-centers/center-agricultural-and-shale-law/agricultural-law-brief
JANUARY 2017
Food Safety: Court Rules FDA did not Negligently Issue Salmonella Warning

Pennsylvania Dept of Ag Warns about Raw Milk Cheese Due to Staph Contamination

PA Dept of Ag is warning consumers who may have purchased raw milk cheese form a Centre County (PA) produce after the Department found the presence of Staphylocuccus aureus.

Pennsylvania Department of Agriculture News Release
http://www.media.pa.gov/pages/Agriculture_details.aspx?newsid=508
Agriculture Department Warns Consumers of Contaminated Cheese from Centre County Dairy
12/29/2016

CDC - 2106 Outbreak of Salmonella Linked to Cucumbers

CDC published a report regarding a 2016 outbreak of Salmonella enterica serotype Oslo.  The report links the outbreak to Persian or mini cucumbers.  "The investigation identified two Canadian Persian cucumber suppliers during the timeframe of interest, but a single grower was not identified."

"This is the fourth Salmonella outbreak since 2013 associated with cucumbers, with over 1,200 illnesses and 260 hospitalizations included in the previous three outbreaks (2–4). Two of these outbreaks were caused by cucumbers sourced from Mexico (2,4), whereas the other outbreak identified cucumbers sourced from Maryland as a major cause of illnesses (3). This outbreak supports the continued evaluation and sampling of produce by FDA with the Food Safety Modernization Act requirements intended to prevent and minimize contamination of produce with pathogens."

CDC - Morbidity and Mortality
https://www.cdc.gov/mmwr/volumes/65/wr/mm655051a3.htm?s_cid=mm655051a3_e
Outbreak of Salmonella Oslo Infections Linked to Persian Cucumbers — United States, 2016
Weekly / December 30, 2016 / 65(5051);1430–1433

Imported Canned Olives Recalled Due to 'Quality Issue' that Could Be a Safety Issue

A New York company is recalling canned olives that were manufactured in Spain due to quality issues that could result in a health issue.  While the notice comes short  of saying the issue, a likely reason would be swollen cans.  Swollen cans can be the result of under-processing or storing cans at an elevated temperature (and thus supporting the growth of thermophilic sporeformers that survived the thermal process).

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm534829.htm
American Roland Food Corp. Initiates A Recall Of Roland® Manzanilla Olives Stuffed With Anchovies Due To Product Quality Issue
For Immediate Release - December 27, 2016

Recalls Continue for Products Using Potentially Contaminated Dairy Powder Ingredient

The recalls have continued for products using the potentially contaminated dairy powders from Valley Dairy. A list of recalls products through 12/21/16 is posted here.

Mikesell’s Recalls 2.25 Oz. Nacho Cheese Tortilla Chips Because Of Possible Health Risk
For Immediate Release December 29, 2016

Tortilla Products Recalled After Complaints of Brittle Plastic Contaminaiton

A Texas establishment is recalling ~23,500 lbs of beef & cheese tortilla products after the company received complaints of foreign objects in the product, specifically clear, brittle plastic.  There have been no reported injuries.

USDA Recall Notice
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-119-2016-release
Ruiz Food Products, Inc. Recalls Beef and Cheese Tortilla Products Due to Possible Foreign Matter Contamination
Class II Recall 119-2016
Health Risk: Low Dec 21, 2016

State Health Department Investigates Own Foodborne Illness Outbreak

An outbreak of foodborne illness affected 70 of the 200 NM State Health Department employees who attended the departmental holiday luncheon.  Epidemiologists from the Department are now investigating their own outbreak.  The luncheon was catered.  No word yet on the cause or the source.

Santa Fe New Mexican
http://www.santafenewmexican.com/news/local_news/staff-members-ill-after-department-of-health-luncheon/article_32e58635-07a0-5aaf-a4df-4ac5b6ea76e9.html
70 staff members ill after Department of Health luncheon

C. perfrigens Identified as Cause of Thanksgiving Foodborne Illness Outbreak

Shortly after Thanksgiving, an outbreak of foodborne illness was reported in California that was linked to a Thanksgiving charity event.  There were 3 deaths and another 22 others who were ill.  The causative agent was found to be Clostridium perfringens, a sporeforming pathogen that can grow rapidly when food is temperature abused.

The actual food source of the bacteria was not found, however investigators "found most of the ill people ate turkey and mashed potatoes and they all ate around the same time. Some dishes served at the event, including cooked turkey, were brought to the site after they were prepared in private homes."

A similar scenario occurred in a 2015 outbreak linked to a Thanksgiving luncheon.  In this case, 40 became ill from food contaminated with Clostridium perfrigens.  In this case however, food was prepared by a caterer.

Clostridium perfrigens: 

• Is a gram positive sporeforming anaerobe.
• Is widely distributed in the environment, but can be found in the intestines of animals and humans (but in small numbers).
• Spores are heat resistant and can survive boiling temperatures.  (Dvalues at 100C can range from 0.31min to 17.5min),
• In heat-treated foods that are temperature abused, this organism can divide in as fast as every 10 minutes.  (The heat treatment eliminates any competitive flora.)  Common food sources include cooked meat foods such as stews and casseroles that are temperature abused.
• Symptoms are caused by ingestion of large numbers ( > 106) vegetative cells or >106 spores/g of food. Toxin production in the digestive tract (or in vitro) is associated with sporulation.  This usually occurs about 16 hours after ingestion.  As the organism numbers increase, it produces an enterotoxin, and this entertoxin is responsible for the illness
• The primary symptoms are cramping and diarrhea and usually dissipate within 24 hours.

The cooling procedures in the Food Code and Appendix B for USDA are established taking C. perfringens into account.

This event points out the risk of having volunteers prepare food in their own home.  In many cases, these people have not been trained in preparing large quantities of food and/or preparing food for events outside of their own home.  In the latter, food transportation can be an issue, especially in warmer areas like California.

CBS SF Bay Area News
http://sanfrancisco.cbslocal.com/2016/12/20/common-bacteria-caused-antioch-thanksgiving-dinner-deaths/
Common Bacteria Caused Antioch Thanksgiving Dinner Deaths
December 20, 2016 11:43 AM

ANTIOCH (CBS SF) — A common food-borne bacteria was responsible for three deaths and the illnesses suffered by 22 others following a Thanksgiving meal sponsored by a community church at Antioch’s American Legion auditorium, health officials announced Tuesday.

FDA Makes Complaint Database Available, Updates Process for Filing Complaints by Consumers

FDA is making its adverse-event database available.  This list voluntary reports of adverse effects from food as well as reports of drugs.

"The new data can be particularly helpful in the area of food-safety issues, Jacobson said, because the FDA has “a very limited budget, and traditionally has been behind the curve in identifying problems and trying to correct them.”
The database “gives some hint about hot spots in the food supply,” Jacobson said. “If you see large numbers, it’s probably not some random consumer making a spurious association between a headache and something they ate.” 

In the past, this information was available though the Freedom of Information Act, now, it will be available for researchers, companies, and of course lawyers.

Interestingly, FDA receives only about 7500 complaints per year.  Not a lot when you think about the number of products sold each day to 320 million people.

The FDA updated procedures for filing complaints for consumers.  FDA directs consumers on how to report non-emergency complaints.   They can call the FDA Consumer Complaint Coordinator assigned for each state or to go online and report to MedWatch website.

Bloomburg BNA
https://www.bna.com/fda-food-cosmetics-n73014448792/
FDA Food, Cosmetics Data Boon for Attorneys, Companies
December 19, 2016