The issues indicate the facility had a rodent issue as well as sanitation issues. Records indicate a rodent issue and this was verified in that numerous rodents had been spotted during the inspection. Issues with sanitation were also noted including improper cleaning practices, placement of food contact surfaces on the ground, and excessively filthy equipment.
It is not uncommon to have mice in the manure pit, and that is where most of the mice sightings were made. The more important issue was to what degree was Salmonella within the laying flocks and in the the environments where chicken were housed. Uncontrolled movement of mice and poor cleaning could be factors, but hard to determine the impact of them on the prevalence of Salmonella in chickens and in environment.
FDA 483 Report - Rose Acre Farms
https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM604794.pdf
FEI NUMBER 2000023438
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED TO:
Nathan K. Nickolisen, Complex Manager
FIRM NAME Rose Acre Farms -Hyde County Egg
CITY, STATE AND ZIP CODE Pantego, NC 27860
STREET ADDRESS 1560 Hyde Park Canal Road
TYPE OF ESTABLISHMENT INSPECTED Shell Egg Producer
FDA 483 Report
Date of Inspection 3/26 - 4/11/18
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.
Additionally, the following conditions were observed in the poultry houses:
On 03/26/2018:
• House 9 - one (1) live apparent rodent in manure pit while swabbing about halfway down row two (2) in the pit, and one (1) live apparent rodent observed running across the upper level floor last row 10; two (2) dead apparent rodents observed on the ground, 10+ feet from the front of the houses; daylight observed through an area with spray foam creating a potential pest entrance in the manure pits around the closed roll up door at the front of the house near row four (4).
• House 13 - multiple live apparent rodents running around the staging area in pit, and burrowing in and out of manure piles; five (5) live apparent rodents observed in the manure pits.
On 03/27/2018:
• House 2 - one (1) live apparent rodent, downstairs in row 4, pit area.
• House 6 - one (1) live apparent rodent, in row l, pit area.
• House 1 O - approximately 4-5 apparent Iive rodents in the pit were observed near the staging table and several were observed while dragging swabs, in the pit area; more than IO apparent rodents observed in pit staging area including baby mice.
• Approximately five (5) apparent rodents seen while walking rows during swab collection; also, a large spill/pile of what appeared to be feed with large flying insects too numerous to count between house numbers 10 and 11, directly beside canal.
• House 11 - one (1) live apparent rodent in manure pit while swabbing approximately halfway down row 5; possible apparent rodent burrows observed in the manure piles; apparent dead rodent carcass on row 5; possible apparent rodent hole/bun-ow observed in the large gravel in the front of the house; and l apparent live rodent on the bird platform.
On 3/28/2018
• House 5-three (3) live apparent rodents were observed downstairs, i11 rows 4 & S.
• House 8-two (2) live apparent rodents were observed downstairs, in rows 4 & l.
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.
Specifically,
On 03/28/18, a review of the firm's sanitation procedure, Cleaning Procedure fo1(b) (4 ___ Form# 6.7.0
F-3, Version #3, found that the procedure for cleaning the D {41 in the egg processing facility was not being implemented by management and followed by sanitation employees. Employees were observed bypassing the [6) 4f step, and observed spraying on the detergent and immediately wiping off, not allowing the detergent to soak for the prescribed (b) (4) minutes.
On 03/28/18, 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, pallet􀃶, 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 [butt crack..pants on I hope], 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.
On 03/28/18, we observed a sanitation employee on the right line, packing area, lane (15) (4 utilizing a steel woo) scrubber to scrub debris off egg bu1lers in service, post sanitation. The steel wool scrubber was stored on a cart in a dustpan that bad a pool of water and egg mix with floating food debris and grime.
Throughout the inspection we observed at least 25 flying insects throughout the egg processing facility. The insects were observed landing on food, food contact surfaces, and food production equipment.
On 03/28/18, we observed an employee mix and use a sanitizer on food contact equipment that was not prepared according to the manufacturer instructions. When tested with a quaternary ammonia test strip, the sanitizer was found to be 1500ppmi outside of the acceptable range of b 4 ppm.
https://www.fda.gov/food/recallsoutbreaksemergencies/outbreaks/ucm604644.htm
FDA Investigates Multistate Outbreak of Salmonella Braenderup Linked to Shell Eggs from Rose Acre Farms
April 18, 2018
Fast Facts
- The FDA is advising consumers not to eat recalled eggs produced by Rose Acre Farms’ Hyde County farm. According to Rose Acre Farms’ recent recall notice and the subsequent recall from Cal-Maine Foods, Inc., these eggs are sold under multiple brand names, including Coburn Farms, Country Daybreak, Food Lion, Glenview, Great Value, Nelms, Sunshine Farms, Publix, and Sunups. Recalled eggs were also sold to restaurants.
- CDC reports 23 cases in nine states with six hospitalizations and no deaths.
- After learning that all of the people who became ill ate eggs or egg dishes, the FDA was able to trace back the source of some of the eggs to the Rose Acre Farms’ Hyde County farm. FDA investigators then inspected the farm and collected samples for testing. FDA analysis of the samples revealed that the same strain of Salmonella Braenderup that caused the illnesses was present at the Hyde County Egg facility, tying the facility to the outbreak.
- As a result of these findings and discussions between the FDA and the firm, Rose Acre Farms has voluntarily recalled eggs from the farm in Hyde County, North Carolina. Following Rose Acre Farms’ recall, Cal-Maine Foods, Inc. voluntarily recalled eggs purchased from Rose Acre Farms and produced at the Hyde County facility.
- If anyone has the recalled eggs in their home, they should not eat them. All consumers should check their eggs for a plant number of P-1065 and a Julian date between 011 and 102 or a plant number P-1359D and Julian date 048A or 049A with Best By dates of APR 02 and APR 03.
The FDA is advising consumers not to eat recalled eggs produced by Rose Acre Farms’ Hyde County farm. These eggs are sold under multiple brand names, including Coburn Farms, Country Daybreak, Food Lion, Glenview, Great Value, Nelms, Sunshine Farms, Publix, and Sunups. Recalled eggs were also sold to restaurants.
The CDC reports that 23 people infected with the outbreak strain of Salmonella Braenderup have been reported from 9 states: Colorado (1), Florida (2), New Jersey (1), New York (6), North Carolina (4), Pennsylvania (2), South Carolina (1), Virginia (5), and West Virginia (1). Six people have been hospitalized, and no deaths have been reported.
After learning that all of the people who became ill ate eggs or egg dishes before the onset of illness, the FDA was able to trace back the source of some of the eggs to the Rose Acre Farms’ Hyde County farm. FDA investigators then inspected the farm and collected samples for testing. During the inspection, FDA investigators observed objectionable conditions and practices which are summarized in the 483 report. FDA analysis of the samples revealed that the same rare strain of Salmonella Braenderup that caused the illnesses was present at the Hyde County Egg facility, tying the facility to the outbreak.
As a result of these findings and discussions between the FDA and the firm, Rose Acre Farms voluntarily recalled shell eggs from the Hyde County egg farm. The affected Rose Acre Farms recalled eggs are identified with plant number P-1065 and Julian date ranges of 011 through date of 102 printed on either the side portion or the principal side of the carton or package. These eggs are sold under multiple brand names including Coburn Farms, Country Daybreak, Food Lion, Glenview, Great Value, Nelms, and Sunshine Farms. Recalled eggs were also sold to restaurants.
Following Rose Acre Farms’ recall, Cal-Maine Foods, Inc. voluntarily recalled eggs purchased from Rose Acre Farms and produced at the Hyde County facility. These eggs were repackaged and sold under multiple brand names, including Publix and Sunups.
Consumers who have any of these shell eggs in their homes should not eat them and should throw them away or return them to the place of purchase for credit or refund. All consumers should check their eggs for a plant number of P-1065 and a Julian date between 011 and 102 or a plant number P-1359D and Julian date 048A or 049A with Best By dates of APR 02 and APR 03.
This investigation is ongoing and the FDA will provide updates when more information is available.
Timeline
On March 5, 2018, the FDA learned about a cluster of Salmonella Braenderup infections in multiple states.
In the following weeks, the FDA, CDC, and state partners worked together to collect additional information and conduct traceback activities to identify a food item of interest. Interviews with ill people allowed health partners to identify eggs as a possible source of the illnesses. The FDA collected and reviewed extensive records to identify the source of the eggs that people ate.
From March 26 – April 11, 2018, the FDA conducted a thorough inspection of the Rose Acre Farms’ Hyde County farm and collected samples for testing.
On April 11, 2018, laboratory analysis by the FDA confirmed that a sample containing Salmonella from the Hyde County Egg Farm facility matches the rare outbreak strain. This evidence demonstrates that eggs from the Rose Acre Farms’ Hyde County farm are the likely source of the outbreak.
On April 13, 2018, Rose Acre Farms voluntarily recalled eggs with plant number P-1065 and Julian date ranges of 011 through 102, printed on the cartons (for more specific information on recalled products, see the list below).
As of April 16, 2018, the CDC reports 23 cases in nine states with six hospitalizations and no deaths.
On April 16, 2018, Cal-Maine Foods, Inc. voluntarily recalled eggs purchased from Rose Acre Farms and produced at the Hyde County facility. These eggs were re-packaged with plant number P-1359D, a Julian date of 048A or 049A, and a best by date of April 2, 2018 or April 3, 2018.
The investigation is ongoing and FDA will provide updated information as it becomes available.
What are the Symptoms of Salmonella?
Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps. The illness usually lasts 4 to 7 days, and most people recover without treatment.
How Soon After Exposure do Symptoms Appear?
On March 5, 2018, the FDA learned about a cluster of Salmonella Braenderup infections in multiple states.
In the following weeks, the FDA, CDC, and state partners worked together to collect additional information and conduct traceback activities to identify a food item of interest. Interviews with ill people allowed health partners to identify eggs as a possible source of the illnesses. The FDA collected and reviewed extensive records to identify the source of the eggs that people ate.
From March 26 – April 11, 2018, the FDA conducted a thorough inspection of the Rose Acre Farms’ Hyde County farm and collected samples for testing.
On April 11, 2018, laboratory analysis by the FDA confirmed that a sample containing Salmonella from the Hyde County Egg Farm facility matches the rare outbreak strain. This evidence demonstrates that eggs from the Rose Acre Farms’ Hyde County farm are the likely source of the outbreak.
On April 13, 2018, Rose Acre Farms voluntarily recalled eggs with plant number P-1065 and Julian date ranges of 011 through 102, printed on the cartons (for more specific information on recalled products, see the list below).
As of April 16, 2018, the CDC reports 23 cases in nine states with six hospitalizations and no deaths.
On April 16, 2018, Cal-Maine Foods, Inc. voluntarily recalled eggs purchased from Rose Acre Farms and produced at the Hyde County facility. These eggs were re-packaged with plant number P-1359D, a Julian date of 048A or 049A, and a best by date of April 2, 2018 or April 3, 2018.
The investigation is ongoing and FDA will provide updated information as it becomes available.
What are the Symptoms of Salmonella?
Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps. The illness usually lasts 4 to 7 days, and most people recover without treatment.
How Soon After Exposure do Symptoms Appear?
Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection.
What are the Complications of Salmonella Infections?
In some people, the diarrhea may be so severe that the patient needs to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream, and then to other body sites and can cause death unless the person is treated promptly with antibiotics.
Who is at Risk?
Children are the most likely to get salmonellosis. The rate of diagnosed infections in children less than five years old is higher than the rate in all other persons. Children younger than 5 years of age, the elderly, and those people with weakened immune systems are more likely to have severe infections. It is estimated that approximately 400 persons die each year with acute salmonellosis.
What Specific Products are Being Recalled?
Consumers and retailers should check the carton or packaging of their eggs. Recalled products have a stamped PLANT NUMBER of P-1065 and a LOT CODE or JULIAN DATE between 011 and 102 or a PLANT NUMBER P-1359D and JULIAN DATE 048A or 049A.
Plant numbers and Julian dates are printed on individual boxes, with the Julian date following the Plant number, for example P-1359D-048A.
\
What are the Complications of Salmonella Infections?
In some people, the diarrhea may be so severe that the patient needs to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream, and then to other body sites and can cause death unless the person is treated promptly with antibiotics.
Who is at Risk?
Children are the most likely to get salmonellosis. The rate of diagnosed infections in children less than five years old is higher than the rate in all other persons. Children younger than 5 years of age, the elderly, and those people with weakened immune systems are more likely to have severe infections. It is estimated that approximately 400 persons die each year with acute salmonellosis.
What Specific Products are Being Recalled?
Consumers and retailers should check the carton or packaging of their eggs. Recalled products have a stamped PLANT NUMBER of P-1065 and a LOT CODE or JULIAN DATE between 011 and 102 or a PLANT NUMBER P-1359D and JULIAN DATE 048A or 049A.
Plant numbers and Julian dates are printed on individual boxes, with the Julian date following the Plant number, for example P-1359D-048A.
\
What Do Consumers Need To Do?
People should not eat any shell eggs from the lots listed above. If they have any of the listed products, they should throw them in the garbage or return them to the place of purchase for credit or refund.
•People who think they might have become ill from eating possibly contaminated eggs should talk to their health care providers.
•Consumers should always practice safe food handling and preparation measures. Wash hands, utensils, and surfaces with hot, soapy water before and after handling raw eggs and raw egg-containing foods. ◦Cook eggs until both the yolk and the white are firm. Scrambled eggs should not be runny.
◦Casseroles and other dishes containing eggs should be cooked to 160° F. Use a food thermometer to be sure.
◦For recipes that call for eggs that are raw or undercooked when the dish is served – like Caesar salad dressing and homemade ice cream – use either shell eggs that have been treated to destroy Salmonella, by pasteurization or another approved method, or pasteurized egg products.
•.For food preparation surfaces and food cutting utensils that may have come in contact with the potentially contaminated eggs, it is very important that the consumers thoroughly clean these areas and items.
Who Should be Contacted?
People who think they might have become ill from eating possibly contaminated or recalled shell eggs should talk to their health care providers. Contact your healthcare provider if you have diarrhea that lasts for more than 3 days, or is accompanied by high fever, blood in the stool, or so much vomiting that you cannot keep liquids down and you pass very little urine.
The FDA encourages consumers with questions about food safety to call 1-888-SAFEFOOD Monday through Friday between 10 a.m. and 4 p.m. Eastern time, or to consult the fda.gov website: http://www.fda.gov.
The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer, the CDC and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.
•People who think they might have become ill from eating possibly contaminated eggs should talk to their health care providers.
•Consumers should always practice safe food handling and preparation measures. Wash hands, utensils, and surfaces with hot, soapy water before and after handling raw eggs and raw egg-containing foods. ◦Cook eggs until both the yolk and the white are firm. Scrambled eggs should not be runny.
◦Casseroles and other dishes containing eggs should be cooked to 160° F. Use a food thermometer to be sure.
◦For recipes that call for eggs that are raw or undercooked when the dish is served – like Caesar salad dressing and homemade ice cream – use either shell eggs that have been treated to destroy Salmonella, by pasteurization or another approved method, or pasteurized egg products.
•.For food preparation surfaces and food cutting utensils that may have come in contact with the potentially contaminated eggs, it is very important that the consumers thoroughly clean these areas and items.
Who Should be Contacted?
People who think they might have become ill from eating possibly contaminated or recalled shell eggs should talk to their health care providers. Contact your healthcare provider if you have diarrhea that lasts for more than 3 days, or is accompanied by high fever, blood in the stool, or so much vomiting that you cannot keep liquids down and you pass very little urine.
The FDA encourages consumers with questions about food safety to call 1-888-SAFEFOOD Monday through Friday between 10 a.m. and 4 p.m. Eastern time, or to consult the fda.gov website: http://www.fda.gov.
The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer, the CDC and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.
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