Inspections, Compliance, Enforcement, and Criminal Investigations
Fremont Farms L.C. 10/21/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
October 21, 2011
RETURN RECEIPT REQUESTED
Ref. – KAN 2012-01
Blair J. Van Zetten, Partner/Owner
Fremont Farms L.C.
543 9th Avenue East
Oskaloosa, Iowa 52577
Dear Mr. Van Zetten:
The United States Food and Drug Administration (FDA) inspected your shell egg production facility located at 3205 295th Street, Fremont, Iowa, on June 23-29, 2011. During the inspection, FDA found that your facility had serious violations of the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (the shell egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR 118). Egg production at your farm must comply with all of the requirements of 21 CFR 118, which applies to farms where any of the eggs produced at the farm do not receive a treatment as defined in 21 CFR 118.3. Failure to comply with the provisions of 21 CFR 118 causes your shell eggs to be in violation of Section 361(a) of the Public Health Service Act (the PHS Act), [42 U.S.C. § 264(a)]. In addition, these violations render your shell eggs adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the 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 may find the Act, the PHS Act, and the shell egg regulation through links on FDA’s home page at www.fda.gov.
Your significant violations were as follows:
1. You failed to clean and disinfect a poultry house appropriately before new laying hens were added to the house when there was an SE positive environmental test, as required by 21 CFR 118.4(d). A review of your firm’s records shows that House 1 had a positive SE environmental result on (b)(4). The poultry house was cleaned following your firm’s written SE plan on (b)(4), which does not include the removal of all visible manure, as required under 21 CFR 118.4(d)(1). Your Farm Manager confirmed that manure was not removed from the pits of House 1 during cleaning. This poultry house was repopulated on (b)(4), with SE clean birds. Your written response dated July 11, 2011, stated that your SE plan will be amended to include complete removal of manure from any house with an environmental positive for SE prior to repopulation. Furthermore, management stated to FDA’s investigators that the eggs produced from House 1 would be diverted to treatment for the life of the flock. FDA will verify both of these corrections during the next inspection.
2. Your environmental sampling plan is not appropriate to your poultry house layout, as required by 21 CFR 118.7(a). Specifically, your procedure “Environmental Sampling for SE” does not include provisions for taking environmental samples from the egg belts or the manure pits in any of your firm’s poultry houses. Your written response dated July 11, 2011, stated that your sampling procedure has been revised to reflect swabbing manure pits. FDA suggests including an appropriate sampling procedure for situations where manure pits are inaccessible for sampling.
Additionally, we note that your firm’s use of (b)(4) as a tool for conducting environmental testing has not been recognized by FDA as being equivalent to the method entitled “Environmental Sampling and Detection of Salmonella in Poultry Houses” cited in 21 CFR 118.8(a). Your written response dated July 11, 2011, stated that in the future you would use a (b)(4) with (b)(4) milk as a tool for conducting environmental testing for SE. This method also has not been recognized by FDA as being equivalent to the method entitled “Environmental Sampling and Detection of Salmonella in Poultry Houses,” which specifies the use of gauze pads moistened with canned evaporated milk. We encourage you to submit additional documentation to FDA, so that we can determine if the method you intend to use would allow for a testing methodology that is equivalent to the method entitled “Environmental Sampling and Detection of Salmonella in Poultry Houses” in accuracy, precision, and sensitivity in detecting SE.
3. You failed to have a written SE prevention plan that includes, at a minimum, the SE prevention measures required by 21 CFR 118.4. Specifically:
• Your procedure “Policy Statement – Bio Security” does not include practices that will protect against cross contamination when equipment is moved among poultry houses, as required under 21 CFR 118.4(b)(2); practices that will protect against cross contamination when persons move between poultry houses, as required under 21 CFR 118.4(b)(3); and measures to prevent stray poultry, wild birds, cats, and other animals from entering poultry houses, as required under 21 CFR 118.4(b)(4).
• Your procedure “Pest Control Policy” does not include provisions for removal of debris and vegetation outside the poultry houses which may provide harborage for pests, to comply with 21 CFR 118.4(c)(3).
• Your procedures “Policy Statement – Cleaning Between Flocks” and “Cleaning and Disinfecting Between Flocks” do not include provisions for removal of all visible manure before new laying hens are added to a poultry house that has had an environmental test or an egg test that was positive for SE at any point during the life of the flock that was housed in the poultry house prior to depopulation, to comply with 21 CFR 118.4(d)(1). It has been your practice to remove manure from pits annually regardless of the SE status of the house.
Your written response dated July 11, 2011, stated that your firm’s Bio Security and Pest Control policies were revised to include the measures cited above. As was discussed above, your written response also stated that your SE plan will be amended to include complete removal of manure from any house with an environmental positive for SE prior to repopulation. FDA will verify these corrections during the next inspection.
4. With respect to your fly monitoring procedures, you failed to implement your written SE prevention plan and to follow the SE prevention measures set forth in 21 CFR 118.4, as required by that provision. Specifically, you failed to use an appropriate fly monitoring method, as required under 21 CFR 118.4(c)(2), as follows:
• Your records indicate only sporadic monitoring for flies. Your procedure “Fly Monitoring and Control” states to perform fly monitoring (b)(4); however, on several occasions monitoring was not performed, including February 27, 2011 and May 22, 2011.
• Your procedure “Fly Monitoring and Control” indicates a fly count below (b)(4) is acceptable and outlines corrective actions for fly counts in excess of (b)(4), but does not specify if corrective actions are needed for fly counts ranging from (b)(4).
We acknowledge that in your written response dated July 11, 2011, you stated that your firm’s Fly Monitoring and Control procedure was revised on (b)(4), to include parameters for taking actions when the fly count is greater than (b)(4) flies; however a description of the corrective actions was not included with your written response. FDA will verify this correction during the next inspection.
5. With respect to your rodent monitoring procedures, you failed to implement your written SE prevention plan and to follow the SE prevention measures set forth in 21 CFR 118.4, as required by that provision. Specifically, you failed to implement appropriate rodent monitoring methods as required by 21 CFR 118.4(c)(1): In some respects, your “Rodent Monitoring and Control” procedure itself is inadequate. Specifically, your procedure is not specific about the number of traps to be placed, but instead allows for ranges to be set (i.e. (b)(4) traps on each side of the building in aisles (b)(4) and (b)(4)). In other respects your written procedure is adequate but your implementation is inadequate (as well as not in keeping with your written procedure). Specifically, your written procedure requires documentation of the number of rodents found (b)(4), but records show you are only recording the total number of rodents (b)(4). You are also failing to maintain records documenting compliance with your SE prevention measures relating to rodent control, as required under 21 CFR 118.10(a)(3)(ii). Specifically, your monitoring records do not indicate the number of traps set in each area of the poultry house.
In addition, FDA is concerned by the fact that your procedure allows for an excess of (b)(4) rodents to be found in a house before corrective action is taken. We also note that there were two live mice and 5 dead mice observed in House 4, and one dead mouse observed in House 6.
Your written response dated July 11, 2011, stated that your firm’s Rodent Monitoring and Control procedure was revised on (b)(4), to include (b)(4) monitoring of traps and bait stations and the use of Rodent Index parameters to take corrective actions. However, a description of the corrective actions was not included with your written response.
The above identification of violations is not intended to be an all-inclusive list of deficiencies 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 Act, the PHS Act, and the shell egg regulation. You also have a responsibility to use procedures to prevent future violations of these statutes and regulations.
In addition to the above violations, we also have the following comment. Your firm’s procedure “Fly Monitoring and Control” states that houses are to be sprayed with (b)(4) when fly counts exceed (b)(4). However a review of your firm’s fly monitoring records shows that fly counts exceeded (b)(4) on January 6, 2011 in houses 1, 2, 3, 4, and 7, but the aforementioned corrective action was not performed. Records indicate that fly counts for House 6 exceeded (b)(4) flies on February 2 and February 9, 2011, but no corrective action was performed. It is important that your firm follow corrective actions as indicated in your established procedures in order to accomplish your firm’s pest control activities.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step which has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating corrections have been made.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures under 21 CFR 118.12(a).
Your response should be sent to Patrick L. Wisor, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 11630 West 80th Street, Lenexa, Kansas 66214-3340.
John W. Thorsky
Kansas City District Office