FDA wants Rose Acre Farm Inc. to clean up its NC shell egg farm

You would be correct if you assumed a lot of cleanup would be required after a 10-state outbreak of Salmonella braenderup that last spring required a North Carolina shell egg farm to recall more than 206 million eggs. It was the largest recall of shell eggs in the United States since 2010.

The cleanup responsibility falls on Seymour, IN-based Rose Acre Farms Inc., the nation’s second-largest egg producer and owner of the Hyde County, NC, shell egg farm. It is one of 17 egg production centers owned by Rose around the country.

The U.S. Food and Drug Administration recently let Rose Acre Farm again know that the processing area of its shell egg farm in Hyde County, NC, tested positive for S. braenderup, the outbreak strain, in numerous locations and that its laying houses were rife with rodent activity.

FDA disclosures came in a Sept. 6 warning letter to Marcus Rust, Rose’s chief executive officer. The warning letter details FDA’s findings from its inspection of the Rose Hyde County, NC location, which occurred from March 26 through April 11, 2018.  Among other infractions, FDA said Rose was in violation of its egg safety rule.

The warning letter, signed by Ingrid A. Zambrana, FDA’s director for the Atlantic District, says epidemiological, traceback, and laboratory evidence all point to the North Carolina shell egg farm owned by Rose as “the likely source of this multi-state S. braenderup outbreak.” During the inspection, FDA collected environmental samples from the poultry houses and processing plant.

“FDA laboratory analyses of the environmental samples collected found the presence of S. braenderup in six (6) environmental swabs in the processing plant in Zones 2 and 3 (Sample #1036614) and two (2) from manure in egg laying house #9 (Sample #1001781),” according to the warning letter.

“Additionally, Salmonella heidelberg (S. heidelberg) was found in eleven (11) environmental swabs in the processing plant in Zones 2 and 3 (Sample #1036614) and one (1) environmental swab from manure in egg laying house #10 (Sample #1005461). S. heidelberg has been shown to be able to contaminate eggs via the transovarian route and has been implicated in multiple egg-associated outbreaks.” the letter adds.

S. braenderup and S. heidelberg are both human pathogens that can cause food to be adulterated under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

Additionally, environmental positives were found in multiple locations in the processing area, mostly where there was standing water or condensation from the ceiling or walls.  Rose’s rodent control measures were also found to be inadequate.

“A review of the pest monitoring forms for the period of September 1, 2017, through March 22, 2018 (29 weeks) revealed the following five houses were consistently operating in a rodent activity range that required corrective actions:

• Laying house 9 – for 14 weeks, rodent counts were between 11 and 27
• Laying house 10 – for 26 weeks, rodent counts were between 12 and 22
• Laying house 11 – for 11 weeks, rodent counts were between 11 and 22
• Laying house 12 – for 18 weeks, rodent counts were between 11 and 19
• Laying house 13 – for 20 weeks, rodent counts were between 11 and 18

“Also, from March 26 through March 28, 2018, the investigators observed more than forty (40) live rodents in eight out of twelve laying houses, specifically:

• Laying house 10 – Approximately four to five (4-5) live rodents in the pit staging table, several in the pit area, and more than ten (10) rodents in the pit staging area, including baby mice
• Laying house 13 – Multiple live rodents running around the pit staging area and burrowing in and out of manure piles, and five (5) live rodents in the manure pits
• Laying house 9 – Three (3) live rodents in the manure pit, one (1) live rodent running across the upper-level floor, and two (2) dead rodents on the ground.
• Laying house 11 – One (1) live rodent in the manure pit, one (1) live rodent on the bird platform, one (1) dead rodent, and rodent burrows observed in the manure piles and the large gravel in the front of the laying house
• Laying house 5 – Three (3) live rodents downstairs, in rows 4 and 5
• Laying house 8 – Two (2) live rodents downstairs, in rows 1 and 4
• Laying house 6 – One (1) live rodent, in row 1 pit area
• Laying house 2 – One (1) live rodent downstairs, in row 4 pit area “

FDA blamed the large rodent infestation on Rose’s poor employee practices and said that without using sanitizers, cleaning alone does not remove microorganisms on surfaces.

“Throughout the inspection, the investigators observed equipment such as conveyor belts, chains, rail guards, buffers, egg transport arms, egg clappers, production computers, and exterior equipment surfaces with an accumulation of dried eggs, shells, and grime post sanitation,” the warning letter says. “These same areas were observed uncleaned on multiple days during the inspection pre and post sanitation.”

FDA recognized Rose for the recall earlier this year of 206 million shell eggs, produced at the North Carolina facility from Jan. 11, 2018 to April 12, 2018.    The agency has asked Rose to respond within 15 days to the warning letter with documentation of  its corrective actions.

Rose was provided with FDA’s inspection observations last April 11, and responded on Aug. 6 with a “restoration plan” for the Hyde County facility. “We are aware that you are currently diverting shell eggs from this farm to egg products processing,” FDA’s district director wrote.   “Further, you have stated that you are in the process of depopulating all flocks and cleaning and disinfecting all laying houses. Thereafter, you plan to conduct environmental testing of each laying house as verification of your cleaning and disinfecting. In addition, you have contracted and are currently working with a professional rodent extermination company to address the rodent issues at your firm. Furthermore, you committed to improving your good manufacturing practices (GMPs), procedures for cleaning and sanitizing, and environmental monitoring program in the processing plant. We will verify the implementation of your corrective actions and their adequacy during the next FDA inspection.”

The public first learned of the S. braenderup outbreak on April 16, 2018, and the federal Centers for Disease Control and Prevention (CDC) declared it over on June 14, 2018 with 45 confirmed illnesses in the ten states.   Eleven required hospital care.  All of the outbreak victims survived.

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