| Public Health Service Food and Drug Administration |
| Detroit District 300 River Place Suite 5900 Detroit, MI 48207 Telephone: 313-393-8100 FAX: 313-393-8139 |
Department of Health and Human Services WARNING LETTER
2011-DET-12
VIA UPS
July 14, 2011
Ms. Lois M. Rust
Rose Acre Farms, Inc., President
6874 N. Base Road
Seymour, IN 47274
Dear Ms. Rust:
FDA conducted an inspection of White County Egg Farm from April 19-22, and on April 28, 2011. FDA laboratory analyses of environmental samples collected during this inspection found the presence of Salmonella enteritidis in egg laying houses (b)(4) and (b)(4). On May 5, 2011 we informed you that three of the five environmental samples collected during the inspection tested positive for Salmonella enteritidis. In addition, during our inspection we found that your facility had violations of the Prevention of Salmonella enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (shell egg regulation), Title 21, Code of Federal Regulations, Part 118 [21 CFR 118]. Failure to adequately implement the requirements in 21 CFR 118 causes your shell eggs to be in violation of Sections 361(a) and 368(a) of the Public Health Service Act, (the "PHS Act"), Title 42 U.S.C. §§264(a) and 271(a). In addition, your shell eggs are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act ("FFD&C Act"), 21 U.S.C. §342(a)(4), in that they have been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the FFD&C Act, the PHS Act, and the shell egg regulation at www.fda.gov.
The most significant violations were as follows:
1. You failed to take appropriate measures to achieve satisfactory rodent control when your own monitoring indicated unacceptable rodent activity, as required under 21 CFR 118.4(c)(1). Specifically, from September 2010 to April 2011, your firm trapped over 21,000 rodents and routinely recorded numbers of observed live rodents in excess of (b)(4) per week in the majority of your firm's egg layer houses. The pest control monitoring section of your firm's SE prevention plan indicates above (b)(4) rodents per week as "Poor Control" and as requiring corrective action. Your firm recorded monthly rodent index totals during these dates of up to 335 rodents in one house, and visual monthly rodent count of up to 162 rodents in one house Additionally, our Investigators observed between 3 and 11 live mice during daylight hours inside five of your firm's egg layer houses. One of the live mice was observed on an egg conveyer belt in house (b)(4) and another live mouse was observed entering a 1-inch diameter hole in house (b)(4)
2. You failed to fully implement and follow the written SE prevention plan, as required under 21 CFR 118.4.
The Rose Acre Farm (RAF) Integrated Pest Management (IPM) Program, signed April 12,2011 indicates that a corrective action must be made if the total number of rodents caught in traps for one building during a week exceed (b)(4). The possible corrective actions listed in the corresponding IPM Form A include re-inspecting exterior bait stations, adding meal bait, employing bromethalin products, and/or using tracking powders in high rodent population areas. Additionally, in the IPM 1.3.1 (b) Visual Rodent Count it refers to a count of (b)(4) as "Poor Control (population reduction)."
Despite this uncontrollable rodent activity data, your firm's rodent monitoring records show repeated increases in the number of live rodents in most of the egg laying houses from one week to the next, even after your firm recorded having made one or more of the possible corrective actions above. Your firm has not fully implemented the "population reduction" that is stated in your own IPM and has failed to achieve significant and sustained reductions in rodent populations below your own IPM threshold levels.
Further, the "White County Egg Farm Biosecurity Plan" created in July 2010 and updated on 3/30/11, Section 1- Biosecurity minimum guidelines for all Rose Acre Farms personnel, Subsections 5 and 6 read in part:
• (b)(4)
• (b)(4)
• (b)(4)
Despite your own biosecurity plan, Investigators observed an approximate 7 x 2-inch hole in the aluminum siding of house (b)(4) within the hole, there was a 1-inch square gap that was open to the inner wall of the layer house. Investigators observed additional entryways for rodents and insects such as a gap in the cement foundation of house (b)(4) gaps formed by aluminum siding that was either bent or extended from the foundation in house #(b)(4) and house (b)(4) fan cover slats that were completely open while the fans were turned off in house (b)(4) and house #(b)(4). Investigators also observed an approximate 7-inch diameter mound of rodent nesting material inside the protective vent screen located beneath the roof overhang inside house (b)(4)
Further, FDA's finding of SE in environmental samples collected at three of your firm's egg laying houses, coupled with the alarmingly high rodent population documented by your firm, increase the likelihood of SE-positive eggs being produced at your facility. The continued lack of rodent control throughout the egg laying houses at your firm's Monon, IN facility greatly increases the risk of eggs becoming contaminated with SE and causing injury to consumers.
On May 19, 2011, FDA received your letter dated May 16, 2011 responding to the FDA 483 Inspectional Observations issued on April 28, 2011, at the conclusion of the inspection at White County Egg Farm in Monon, IN. The response is inadequate because it fails to identity the root cause of the rodent problem and did not contain timelines for your corrective actions.
The FDA requests a meeting with you to discuss the specific steps taken to correct the violations, a timeline for total compliance, and the steps that will be taken to prevent the recurrence of the violations described in this letter. All corrective actions must be taken on a whole farm basis due to the extensive rodent population throughout all fourteen houses. Please come to the meeting prepared to discuss the following.
• Egg diversion for all (b)(4) houses until your facility is in compliance with 21 CFR 118.4(c).
• Laboratory methodologies used to analyze egg samples.
• Methods being used to obtain satisfactory rodent control.
• General repair of your poultry houses to prevent ingress of rodents.
• Structural changes that will effectively remedy your extensive rodent population, including removal of cellulose material in house ceilings or other such harborage and nesting locations.
The meeting is scheduled for (b)(5) at FDA's Detroit District Office located at 300 River Place, Suite 5900, Detroit, MI 48207. Please contact Cicely Vaughn, Compliance Officer, at (313) 393-8297, to confirm this meeting and provide a list of attendees.
This letter is not intended to be an all-inclusive list of violations at your facility. You are responsible for ensuring that your shell egg production facility operates in compliance with all applicable statutes and regulations, including the FFD&C Act, the PHS Act, and the shell egg regulation. You also have a responsibility to use procedures to prevent further violations of these statutes and regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Sincerely,
/S/
Keith J. Jasukaitis
Acting Detroit District Director
Detroit District Office
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