Rose Acre Farms – FDA 483 Investigation Report

Observation 1:
When your monitoring indicated unacceptable rodent activity within a poultry house, appropriate methods were not used to achieve satisfactory rodent control.

Specifically, a review of your pest control records from September 2017 to present indicate an ongoing rodent infestation. The corrective actions taken by your firm have not been effective at reducing the rodent levels within your poultry houses to an acceptable level that is below the threshold established in your SE Prevention Plan.

Observation 2:
There were insanitary conditions and poor employee practices observed in the egg processing facility that create an environment that allows for the harborage, proliferation and spread of filth and pathogens throughout the facility that could cause the contamination of egg processing equipment and eggs.

On 03/28118, during a review of the firm’s cleaning procedures and a walkthrough of the cleaning procedures we observed that the firm did not have in their procedures or use a sanitizing step following the wash step.

Throughout the inspection we observed condensation dripping from the ceiling, pipes, and down walls, onto production equipment (i.e. crack detector, egg grader) and pooling on floors in foot traffic and forklift pathways.

On 03/28/18, we observed maintenance and sanitation employees placing buffers (food contact) and metal covers to the egg packer with buffers (non-food contact) onto floor, pa11ets, and equipment that was visibly dirty with accumulated grime and food debris, before placing the equipment into service. Additionally, throughout the inspection several production and maintenance employees were observed touching non-food contact surfaces (i.e. face, hair, intergluteal cleft, production equipment with accumulated grime and food debris, floor, boxes, trash cans, inedible transport cans) and then touch shell eggs and food contact surfaces (i.e. buffers, rollers, etc.) without changing gloves or washing hands. We also observed maintenance employees dragging non-food contact equipment (i.e. black electrical conduit with accumulated grime and dried food debris) on top of food contact surfaces (i.e. conveyors and rollers).

Throughout the inspection we observed equipment (i.e. conveyor belts, chains, rail guards, buffers, egg transport arms, egg clappers, production computers and exterior of production equipment surfaces) with accumulated food debris (i.e. dried egg and shells) and grime, post sanitation. The same areas of accumulated food debris were observed uncleaned on multiple days during the inspection pre-and post-sanitation.

Rose Acre Farms of Seymour, Indiana is voluntarily recalling 206,749,248 eggs because they have the potential to be contaminated with Salmonella Braenderup, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals infected with Salmonella Braenderup can experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella Braenderup 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 eggs were distributed from the farm in Hyde County, North Carolina and reached consumers in the following states: Colorado, Florida, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia through retail stores and restaurants via direct delivery.

22 illnesses have been reported to date.

The affected eggs, from plant number P-1065 with the Julian date range of 011 through date of 102 printed on either the side portion or the principal side of the carton or package, as follows:

Lot Codes 011 – 102

Item Description Carton UPC
COUNTRY DAYBREAK A LARGE X 30 DOZEN 077236000302
COUNTRY DAYBREAK A LARGE X15 DOZEN 077236000302
COUNTRY DAYBREAK A JUMBO X24 DOZEN 077236000500
COUNTRY DAYBREAK A MEDIUM X30 DOZEN 077236000203
COUNTRY DAYBREAK A XLARGE X30 DOZEN 077236000401
COUNTRY DAYBREAK A JUMBO X12 DOZEN 077236000500
FOOD LION A JUMBO X 12 DOZEN 035826089618
FOOD LION A MEDIUM X15 DOZEN 035826089649
FOOD LION A XLARGE X 15 DOZEN 035826089625
FOOD LION A 18PK LARGE X15 DOZEN 035826089601
FOOD LION A LARGE X15 DOZEN 035826089588
FOOD LION A 6PK LARGE X 15 DOZEN 035826089632
LOOSE A USDA SMALL X 30 DOZEN N/A
LOOSE A USDA MEDIUM X 30 DOZEN N/A
LOOSE A XLARGE X15 DOZEN N/A
LOOSE A XLARGE X30 DOZEN N/A
LOOSE A MEDIUM X 15 DOZEN N/A
LOOSE A MEDIUM X30 DOZEN N/A
LOOSE USDA AA XLARGE X30 DOZEN N/A
LOOSE USDA AA XLARGE X15 DOZEN N/A
LOOSE USDA AA LARGE X30 DOZEN N/A
LOOSE USDA AA LARGE X15 DOZEN N/A
LOOSE USDA AA MEDIUM X30 DOZEN N/A
LOOSE AA XLARGE X30 DOZEN N/A
LOOSE USDA AA LARGE PFG X 30 DOZEN N/A
LOOSE USDA AA LARGE PFG X 15 DOZEN N/A
LOOSE USDA A XLARGE X30 DOZEN N/A
NELMS A JUMBO X24 634181000018
WAFFLE HOUSE LOOSE USDA A LARGE X 30 DOZEN N/A
CRYSTAL FARMS A MEDIUM X30 077236000203
CRYSTAL FARMS A 18PK MEDIUM X 30 077236000258
CRYSTAL FARMS A 2.5 DOZ MEDIUM X 25 077236000124
COUNTRY DAYBREAK A XLARGE X15 DOZEN 077236000401
COUNTRY DAYBREAK USDA GRADE A XLARGE X 240 DOZEN PULP 077236700400
COUNTRY DAYBREAK USDA GRADE A LARGE RACK X 240 DOZEN PULP 077236700301
COBURN FARMS A MEDIUM MP X 30 DOZEN 051933182608
COBURN FARMS A LARGE X 30 DOZEN 051933190801
COBURN FARMS A 18PK LARGE X 30 DOZEN 051933182509
SUNSHINE FARMS A JUMBO X 12 DOZEN 804879457336
GLENVIEW USDA AA LOOSE LARGE (6-2.5 FLATS) X 15 DOZEN N/A
GLENVIEW USDA AA LOOSE LARGE (12-2.5 FLATS) X 30 DOZEN N/A
GLENVIEW USDA AA LOOSE MEDIUM (6-2.5 FLATS) X 15 DOZEN N/A
GLENVIEW USDA AA LOOSE XLARGE (6-2.5 FLATS) X 15 DOZEN N/A
GLENVIEW USDA AA LOOSE MEDIUM (12-2.5 FLATS) X 30 DOZEN N/A
GLENVIEW USDA AA LOOSE XLARGE (12-2.5 FLATS) X 30 DOZEN N/A
GREAT VALUE GRADE A USDA 18PK XLARGE X 24 DOZEN RPC 078742127132
GREAT VALUE GRADE A USDA 12PK XLARGE X 24 DOZEN RPC 078742127128
GREAT VALUE GRADE A USDA TWIN 18PK LARGE X 24 DOZEN RPC 078742127101
GREAT VALUE GRADE A USDA 6PK LARGE X 15 DOZEN 078742127095
GREAT VALUE GRADE A USDA 12PK MEDIUM X 15 DOZEN 078742127224
GREAT VALUE GRADE A USDA 12PK LARGE X 24 DOZEN RPC 078742127071
GREAT VALUE GRADE A USDA 18PK LARGE X 24 DOZEN RPC 078742127088
GREAT VALUE GRADE A 12PK JUMBO X 22 DOZEN RPC 078742127149
GREAT VALUE GRADE A USDA 5DZ LARGE X 5 DOZEN 078742127118

The voluntary recall was a result of some illnesses reported on the U.S. East Coast, which led to extensive interviews and eventually a thorough FDA inspection of the Hyde County farm, which produces 2.3 million eggs a day. The facility includes 3 million laying hens with a USDA inspector on-site daily.

To put the dispute in context:  According to the CDC, a total of 265 people infected with the outbreak strains of Salmonella Typhimurium were reported from 8 states (Iowa, Minnesota, Nebraska, South Dakota, Wisconsin, Illinois, Indiana and Mississippi). WGS performed on bacteria isolated from ill people showed that they were closely related genetically. This means that people in this outbreak were more likely to share a common source of infection. Illnesses started on dates ranging from January 8, 2018, to March 20, 2018. Ill people ranged in age from less than 1 year to 89 years, with a median age of 57. Sixty-seven percent of people were female. Ninety-four hospitalizations were reported, including one person from Iowa who died.

Despite the overwhelming evidence from public health officials at the CDC and several states and the FDA and FSIS, this statement dribbled out this morning from the PR folks (assuming not the lawyers) from triple T Specialty Meats:

Triple T Specialty Meats Statement:  On behalf of the Heikens family and everyone at Triple T Specialty Meats, our deepest sympathy goes out to the individuals and families affected by the recent Fareway Chicken Salad incident. During our 22 years in business at Triple T Specialty Meats, consumer health and food safety has always been our number one priority; and will always be our number one priority!

After a thorough investigation and extensive testing by state of Iowa, USDA and FDA inspection teams, no salmonella was found at the Triple T Specialty Meats facility in Ackley. Further, no salmonella was found in any products tested at the Triple T Specialty Meats facility. Finally, all chicken salad produced by Triple T Specialty Meats; that remained in the original sealed packaging, tested negative for salmonella.

“We take this very seriously and will continue to work with all government agencies to assist in determining the source of the salmonella,” said Jolene Heikens, Co-Owner and CEO of Triple T Specialty Meats. “In the meantime, Triple T Specialty Meats is running business as usual and we appreciate our customer’s and the communities continued support. We will continue to provide only the highest quality product and services meeting all USDA and FDA regulations.”

All agency inspector’s reports showing “No Salmonella Found” have been provided to Triple T Specialty Meats and will be made available to customers or vendors upon request.

Triple T Specialty Meats is a family owned and operated specialty meat and food processor established in 1996 and operates in Ackley, Iowa by Greg and Jolene Heikens. The Heikens accredit much of their success to surrounding themselves with exceptional employees, but when you meet the Heikens and become acquainted with their brainstorming, get-after-it, fun-loving personalities, you will understand what makes Triple T Specialty Meats successful, but more importantly special.

I what could only be entitled “The Smack Down in Iowa,” Fareway set the record straight and stopped doing business with Triple T Specialty Meats.  The statement read:

Fareway Stores, Inc. Statement: Fareway Stores, Inc. wants to share information with our customers about the investigation of the outbreak of Salmonella illnesses linked to chicken salad made by Triple T Specialty Meats, Inc. State and federal investigators have concluded that Triple T Specialty Meats, Inc. was the source of the Salmonella Typhimurium in the chicken salad. The Iowa State Hygienic Laboratory found Salmonella Typhimurium in Triple T Specialty Meats, Inc. chicken salad collected from two different Fareway stores located 100 miles apart. One of those positive samples came from a sealed package of Triple T chicken salad that had never been opened by Fareway. 

As USDA’s Food Safety and Inspection Service reported, “the Iowa Department of Public Health, Iowa Department of Inspections and Appeals, and Iowa State Hygienic Laboratory determined that there is a link between the chicken salad from Triple T Specialty Meats, Inc. and this outbreak.” The U.S. Centers for Disease Control and Prevention has also confirmed that chicken salad produced by Triple T Specialty Meats, Inc. was the likely source of this multi-state illness outbreak.

In the course of these investigations, there have been no findings of any food safety issues in Fareway stores. Fareway has stopped doing business with Triple T Specialty Meats, Inc.

Body Slam!

Honestly, Triple T Specialty Meats is getting very bad PR advice, very bad business advice, but hopefully, not bad legal advice – We shall see.

A total of 265 people infected with the outbreak strains of Salmonella Typhimurium were reported from South Dakota, Nebraska, Minnesota, Iowa, Wisconsin, Illinois, Indiana and Mississippi.

Illnesses started on dates ranging from January 8, 2018, to March 20, 2018. Ill people ranged in age from less than 1 year to 89 years, with a median age of 57. Sixty-seven percent of people were female. Ninety-four hospitalizations were reported, including one person from Iowa who died.

Epidemiologic, laboratory, and traceback evidence indicated that chicken salad produced by Triple T Specialty Meats, Inc. and sold at Fareway grocery stores was the likely source of this multistate outbreak.

Investigators in Iowa collected chicken salad from two Fareway grocery store locations in Iowa for laboratory testing. An outbreak strain of Salmonella Typhimurium was identified in both samples.

On February 21, 2018, Triple T Specialty Meats, Inc. recalled all chicken salad produced from January 2, 2018 to February 7, 2018. The recalled chicken salad was sold in containers of various weights from the deli at Fareway grocery stores in Iowa, Illinois, Minnesota, Nebraska, and South Dakota from January 4, 2018 to February 9, 2018.

As of April 6, 2018, this outbreak appears to be over.

According to the CDC, as of March 20, 2018, 13 people infected with the outbreak strain of Salmonella Typhimurium have been reported from 8 states. WGS performed on bacteria isolated from ill people showed that they were closely relatedly genetically. This means that people in this outbreak are more likely to share a common source of infection.

Illnesses started on dates ranging from September 22, 2017 to February 26, 2018. Ill people range in age from 1 to 73 years, with a median age of 40. Sixty-seven percent are female. Three hospitalizations have been reported. No deaths have been reported.

Epidemiologic, laboratory, and traceback evidence indicates that dried coconut is the likely source of this multistate outbreak.

In interviews, ill people answered questions about the foods they ate and other exposures in the week before they became ill. Seven (88%) of eight people interviewed reported eating dried coconut from grocery stores. Of the seven people who reported eating dried coconut, four people purchased the product at different Natural Grocers store locations. Public health officials continue to interview ill people to learn more about what they ate in the week before becoming sick.

FDA and state health and regulatory officials collected leftover dried coconut from ill people’s homes, as well as dried coconut from Natural Grocers store locations where ill people shopped and from the Natural Grocers’ Distribution Center. FDA testing identified the outbreak strain of Salmonella Typhimurium in an unopened sample of Natural Grocers Coconut Smiles Organic collected from Natural Grocers. The outbreak strain was also identified in an opened, leftover sample of Natural Grocers Coconut Smiles Organic collected from an ill person’s home.

FDA also collected dried coconut from International Harvest, Inc. The outbreak strain of Salmonella Typhimurium was identified in samples of International Harvest Brand Organic Go Smile! Dried Coconut Raw and Go Smiles Dried Coconut Raw.

On March 16, 2018, International Harvest, Inc. recalled bags of Organic Go Smile! Raw Coconut and bulk packages of Go Smiles Dried Coconut Raw. The recalled Organic Go Smile! Raw Coconut was sold online and in stores in 9-ounce bags with sell-by dates from January 1, 2018 through March 1, 2019. Recalled bulk Go Smiles Dried Coconut Raw was sold in a 25-pound case labeled with batch/lot numbers OCSM-0010, OCSM-0011, and OCSM-0014. These products were sold in various grocery stores. Regulatory officials are working to determine where else Organic Go Smile! Raw Coconut and Go Smiles Dried Coconut Raw were sold.

On March 19, 2018, Vitamin Cottage Natural Food Markets, Inc. recalled packages of Natural Grocers Coconut Smiles Organic labeled with barcode 8034810 and packed-on numbers lower than 18-075. Recalled Natural Grocers Coconut Smiles Organic were sold in 10-ounce clear plastic bags with the Natural Grocers label. The packed-on number can be found in the bottom left-hand corner of the label.

Federal and state health officials are investigating a multistate Salmonella outbreak connected with a potentially contaminated organic packaged coconut that was sold at Natural Grocers stores, a product that was the subject of a recall posted by the US Food and Drug Administration (FDA) yesterday.

In the recall notice, Vitamin Cottage Natural Food Market, Inc., based in Lakewood, Colo., said it was recalling its Natural Grocers brand 10-ounce Coconut Smiles Organic due to potential Salmonella contamination. It said six illnesses have been reported, the company’s own routine tests found Salmonella in some packages, and a sample taken by the FDA was also positive for Salmonella.

The product is packaged in clear plastic 10-ounce bags bearing the Natural Grocers label. All packages with packed-on dates before 18-075 (Mar 16, 2018) are subject to the recall. The products were distributed to 145 Natural Grocers stores in 19 states: Arkansas, Arizona, Colorado, Iowa, Idaho, Kansas, Minnesota, Missouri, Montana, Nebraska, Nevada, New Mexico, North Dakota, Oklahoma, Oregon, Texas, Utah, Washington, and Wyoming.

Marler Clark has filed several lawsuits and represents three dozen victims.

The CDC reports as of March 6, 2018, 170 people infected with the outbreak strains of Salmonella Typhimurium have been reported from 7 states. Illness Count Iowa (149), Illinois (9), Nebraska (5), Minnesota (3), South Dakota (2) Indiana (1), Texas (1).

Illnesses started on dates ranging from January 8, 2018, to February 18, 2018. Ill people range in age from 7 to 89 years, with a median age of 59. Sixty-six percent of ill people are female. 62 hospitalizations and no deaths have been reported.

Illnesses that occurred after February 12, 2018, might not yet be reported due to the time it takes between when a person becomes ill and when the illness is reported. This takes an average of two to four weeks.

WGS analysis did not identify predicted antibiotic resistance in 67 of 72 isolates (70 ill people and 2 food samples). Five isolates from ill people contained genes for resistance to all or some of the following antibiotics: amoxicillin-clavulanic acid, ampicillin, cefoxitin, ceftriaxone, gentamicin, streptomycin, sulfamethoxazole, and tetracycline. This resistance is unlikely to affect the treatment of most people, but some infections might be difficult to treat with antibiotics usually prescribed and may require a different antibiotic. Testing of outbreak isolates using standard antibiotic susceptibility testing methods is currently underway in CDC’s National Antimicrobial Resistance Monitoring System (NARMS)laboratory.

State and local health officials continue to interview ill people to ask about the foods they ate and other exposures in the week before they became ill. Of 159 people interviewed, 131 (82%) reported eating chicken salad from Fareway stores. Triple T Specialty Meats, Inc. produced the chicken salad that ill people reported eating.

It takes an average of two to four weeks from when a person becomes ill with Salmonella to when the illness is reported to CDC or health officials. Because of this reporting lag, the additional 105 people added to this investigation likely became ill from eating chicken salad recalled by Triple T Specialty Meats, Inc. which is no longer available for purchase. The last reported illness began on February 18, 2018.

As of February 27, 2018, 10 people infected with the outbreak strain of Salmonella Montevideo were reported from 3 states. Illnesses started on dates ranging from December 20, 2017 to January 28, 2018. Ill people ranged in age from 26 to 56, with a median age of 42. All 10 (100%) were female. No hospitalizations and no deaths were reported.

In interviews, ill people answered questions about the foods they ate and other exposures in the week before they became ill. Eight (80%) of ten people interviewed reported eating at multiple Jimmy John’s restaurant locations. Of these eight people, all eight (100%) reported eating raw sprouts on a sandwich from Jimmy John’s in Illinois and Wisconsin. Two ill people in Wisconsin ate at a single Jimmy John’s location in that state. One ill person reported eating raw sprouts purchased from a grocery store in Minnesota.

This outbreak appears to be over. Any contaminated sprouts that made people sick in this outbreak would now be older than their recommended shelf life. FDA and state, and local regulatory officials conducted traceback investigations to help determine the source of the sprouts and their distribution chain. To date, no contamination source has been identified.

Regardless of where they are served or sold, raw and lightly cooked sprouts are a known source of foodborne illness and outbreaks. People who choose to eat sprouts should cook them thoroughly to reduce the risk of illness.

The Weld County Department of Public Health and Environment (WCDPHE) is investigating an outbreak of Salmonella illness at Aims Community College. This illness may be associated with catered events held at Aims on February 9 and February 13, 2018. The February 9 event has 1confirmed Salmonella case that had about 70 people attend. The February 13 event has 2 confirmed cases that was attended by 400 people. Of the 10 confirmed Salmonella cases, 6 adults reside in Weld County, 1 in Larimer, and 1 in Boulder county. The events were catered by an outside restaurant, the Burrito Delight, located in Fort Lupton. The public is not at risk and the restaurant is now closed for the duration of the investigation.

Health officials said Thursday that they have confirmed all 10 illnesses are linked to food served by Burrito Delight at catered events, or at the restaurant between Feb. 9 and 12.

The restaurant failed the health inspection in the following areas: Temperature control, appropriate storage, proper storage of employee drinks, one instance of improper hand washing, and the presence of a rodent. The restaurant has received 12 critical violations in the past year.

“Salmonella is a bacteria that causes symptoms like diarrhea, upset stomach, fever, and occasionally vomiting,” said Mark E. Wallace, MD, MPH, Executive Director of the Weld County Health Department. “Symptoms typically last 4 to 7 days, and most people recover on their own. Anyone who suspects they became ill should contact their health care provider.” For some people, the diarrhea may become so severe that they require hospitalization. Symptoms typically appear 6-72 hours after eating contaminated food and will typically last for 4 to 7 days without treatment. However, in severe cases, the symptoms may last longer.

94 Sick in Iowa, Chicken Salad sold at Fareway grocery stores in Iowa, as well as Illinois, Minnesota, Nebraska and South Dakota.

28 – Confirmed Case Definition:

Persons with Salmonella Typhimurium (confirmed or visual match to Pattern JPXX01.0275) with illness onset since January 1, 2018 reporting consumption of chicken salad from Fareway (any store) in the 7 days prior to illness onset.

66 – Probable Case Definition:

Persons that are epi linked to a confirmed case (all confirmed cases are laboratory confirmed), OR Persons who test positive by CIDT or culture (with serotype and PFGE pending) with illness onset since January 1, 2018 reporting consumption of chicken salad from Fareway (any store) in the 7 days prior to illness onset.

Minnesota has one case associated with this outbreak so far, in a Martin County resident.

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert out of an abundance of caution due to concerns about illnesses reported in the state of Iowa that may be caused by Salmonella associated with a chicken salad product. This product was sold at all Fareway grocery stores in Iowa, as well as Illinois, Minnesota, Nebraska and South Dakota.

The chicken salad item for this public health alert was produced between Dec. 15, 2017 and Feb. 13, 2018. The following product is subject to the public health alert:

  • Varying weights of “Fareway Chicken Salad” sold in plastic deli containers with a Fareway store deli label.

This product was shipped to all Fareway grocery stores in Iowa, Illinois, Minnesota, Nebraska and South Dakota and sold directly to consumers who shopped at Fareway.  The problem was discovered following reports of illness in Iowa.

On Feb. 9, 2018, the Iowa Department of Public Health notified FSIS of an investigation of Salmonella related illnesses, within the state of Iowa.  FSIS continues to work with public health partners at the Iowa Department of Public Health and Department of Inspections and Appeals on this investigation. Updated information will be provided as it becomes available.

FSIS is concerned that some product may be in consumers’ refrigerators or freezers.

Consumers who have purchased these products are urged not to consume them.