| Public Health Service Food and Drug Administration |
| Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 334-4100 FAX: (612) 334-4142 |
Department of Health and Human ServicesNovember 16, 2011
WARNING LETTER
Via UPS Overnight
Refer to MIN 12 - 09
Beth Sparboe Schnell
Owner
Sparboe Farms, Inc. / Prairie Complex
23577 MN Highway 22
Litchfield, Minnesota 55355
Dear Ms. Schnell:
The United States Food and Drug Administration (FDA) inspected your shell egg production facilities located at:
1140 Timber Drive, Goodell, IA 50439 on April 25-29, 2011 (Inspection 1); 65018 U.S. Highway 12, Litchfield, MN 55355 on April 25-May 5, 2011 (Inspection 2); 6339 Weld County Road 47, Hudson, CO 80642 on May 9-12, 2011 (Inspection 3); 2088 120th Street, Humboldt, IA 50548 on June 20-21, 2011 (Inspection 4); and 1979 Iowa Avenue, Britt, IA 50423 on July 20-22, 2011 (Inspection 5).
We found that the above-listed facilities have serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation regulation (the shell egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR 118). The failure to adequately implement the requirements in 21 CFR 118 causes your shell eggs to be in violation of section 361(a) of the Public Health Service Act (the "PHS Act"), Title 42, U.S.C. section 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 "FFD&C Act"), 21 U.S.C. section 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 through links on FDA's home page at www.fda.gov.
The significant violations, with references to each specific farm, are as follows:
1. You failed to have and implement a written SE prevention plan that is specific to each farm where you produce eggs, as required by 21 CFR 118.4. Specifically, your written SE prevention plans obtained during Inspection 1 in Goodell, IA, Inspection 2 in Litchfield, MN, Inspection 3 in Hudson, CO, Inspection 4 in Humboldt, IA, and Inspection 5 in Britt, IA, are not specific to each farm.
2. You induced molt in a flock but then failed to perform environmental testing for SE in the poultry house at four to six weeks after the end of the molting process as required by 21 CFR 118.5(b). Specifically, during Inspection 2 in Litchfield, MN, investigators noted that you failed to environmentally test the poultry house (house #(b)(4) four to six weeks after the end of the molting process. Your written response dated May 25, 2011, states that your SE prevention plan calls for environmental testing four to six weeks after the end of the molting process; however, you did not provide any records to demonstrate that environmental testing did, in fact, take place in this circumstance. To the extent that you are asserting that environmental testing was performed four to six weeks after the end of the molting process in the poultry house (house #(b)(4), you are required under 21 CFR 118.10(a)(3)(vi) to maintain records documenting the results of the SE testing that is required by 21 CFR 118.5.
3. You failed to use appropriate methods to achieve satisfactory rodent control when monitoring indicated unacceptable rodent activity within a poultry house, as required by 21 CFR 118.4(c)(1).
• During Inspection 1 at Goodell, IA, it was noted that when your monitoring indicated unacceptable rodent activity, appropriate measures were not used to achieve satisfactory rodent control. Specifically, your Biosecurity Program and Procedures Manual Version #4, dated September 2009, states the rodent index should be lower than (b)(4) A review of the records for the previous ten months (June 2010- April 2011) found the rodent index exceeded (b)(4) on most of the dates when it was calculated; however, your records indicate that neither your firm nor your contracted pest control company took remedial action to achieve satisfactory rodent control. Your written response dated May 18, 2011, stated that a rodent index of (b)(4) was "a goal, not the starting point for our evaluation," and that adjustments on the rodent control index have been done based on historical trends for the Goodell facility with a new rodent index of (b)(4) However, your response did not indicate that you had concluded that a rodent index of (b)(4) represents an acceptable level of rodent activity, nor did it indicate any basis for such a conclusion. Changing threshold levels to reflect historical levels of rodents is not an acceptable correction. You are required to use appropriate methods to achieve satisfactory rodent control when your monitoring indicates unacceptable rodent activity.
• During Inspection 2 at Litchfield, MN, it was noted that your Biosecurity Program and Procedures Manual Version #4, dated September 2009, states the rodent index should be lower than (b)(4) Between July 9, 2010, and April 22, 2011, the rodent index continuously ranged from (b)(4)((b)(4) rodents caught) to (b)(4) ((b)(4) rodents caught), which exceeded your rodent index of (b)(4) and thus required corrective action according to the pest control section of your firm's SE prevention plan. However, no corrective actions were taken to achieve satisfactory rodent control. Your written response dated May 25, 2011, stated that you will change the rodent index threshold level at which you will take corrective action. However, your response did not indicate what your revised rodent index threshold level would be, nor did it indicate that the revised rodent index would reflect an acceptable level of rodent activity. Changing threshold levels in light of historical levels of rodents is not an acceptable correction. You are required to use appropriate methods to achieve satisfactory rodent control when your monitoring indicates unacceptable rodent activity.
• During Inspection 4 at Humboldt, IA, it was noted that your SE plan stated that action would be taken if a rodent index of (b)(4) was reached. Your rodent monitoring logs indicated that the rodent index exceeded (b)(4) on June 14, 2011 (houses #(b)(4)), May 31, 2011 (houses #(b)(4)), May 24, 2011 (house #(b)(4), May 17, 2011 (house (b)(4) and May 10, 2011 (house #(b)(4). However, no corrective actions were documented. Your written response dated July 12, 2011, stated that in the future, corrective actions will be implemented at a rodent index of (b)(4) We note that, at the time of the inspection, your SE plan stated that you follow FDA's Industry Guidance for rodent indexing. This statement is in conflict with your threshold of a rodent index of (b)(4) which is not consistent with FDA's Draft Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation, which we believe to be the Industry Guidance that is referenced in your SE plan. Please note that whatever monitoring method you use, you are required to use appropriate methods to achieve satisfactory rodent control when your monitoring indicates unacceptable rodent activity.
• During Inspection 5 at Britt, IA, it was noted that when monitoring indicated unacceptable rodent activity, appropriate methods were not used to achieve satisfactory rodent control. Specifically, on November 2, 2010, you recorded a rodent index of (b)(4) for house #(b)(4). Although your SE plan as of November 2, 2010, did not require action at any rodent index level, your Britt Complex Manager acknowledged during the inspection that a rodent index of (b)(4) indicated a problem that needed to be addressed. However, your records indicate that no action was taken to address this unacceptable rodent activity.
4. You failed to remove vegetation and debris outside a poultry house that may provide harborage for pests, as required by 21 CFR 118.4(c)(3). Specifically, during Inspection 5 at Britt, IA, FDA investigators observed a pile of lumber between houses #(b)(4) as well as thick grass standing approximately 4.5 feet tall between houses #(b)(4) FDA investigators observed a rodent run out from under the pile of lumber.
5. You failed to have and implement a written SE prevention plan that includes an appropriate monitoring method for flies and you failed to use appropriate methods to achieve satisfactory fly control when monitoring indicated unacceptable fly activity within a poultry house as required by 21 CFR 118.4(c)(2).
• During Inspection 1 in Goodell, IA, it was noted that, though you use fly cards for monitoring, an unacceptable level of fly activity had not been determined and was not addressed in the Salmonella Prevention Program or your firm's procedures as required under 21 CFR 118.4(c)(2). In your written response dated May 18, 2011, you stated that you updated the Goodell SE Prevention Program to specify fly monitoring activity and set a threshold with corrective actions when those are reached. However, your written response did not indicate what the threshold is for unacceptable fly activity, nor did it indicate what the corrective actions are.
• During Inspection 2 in Litchfield, MN, it was noted that your SE prevention plan references your Biosecurity Program and Procedure Manual #4, which requires fly control procedures in writing; however, there are no written procedures for monitoring of flies and you do not determine if fly activity is acceptable or unacceptable, as required under 21 CFR 118.4(c)(2). Your written response dated May 25, 2011, stated that you will include a written Fly Control Program with threshold levels and take corrective actions when necessary. However, your response did not indicate what the threshold levels will be or what the corrective actions will be.
• During Inspection 5 in Britt, IA, it was noted that the presence of flies is not monitored by appropriate monitoring methods as required under 21 CFR 118.4(c)(2). Specifically, your fly index action level of (b)(4) is based on historical levels of flies, as opposed to being based on a determination of what level of fly activity is unacceptable.
6. You failed to procure pullets that are SE monitored or to raise pullets under SE monitored conditions, as required by 21 CFR 118.4(a). Specifically, you failed to comply with the requirement in 21 CFR 118.4(a)(2) that the pullet environment be tested for SE when pullets are 14 to 16 weeks of age, and that you have and implement a written SE plan that calls for such testing. You also failed to maintain records documenting that pullets were raised under SE monitored conditions, as required by 21 CFR 118.10(a)(2).
• During Inspection 2 in Litchfield, MN, it was noted that house #(b)(4) was populated on or around February 12, 2011, with pullets that were never environmentally monitored. Your written response dated May 25, 2011, states that you will revise your SE prevention plan to state that "pullets" (which we understand to mean the pullet environment) will be tested for SE when pullets are between 14 and 16 weeks of age. We will verify this correction at our next inspection.
• During Inspection 4 in Humboldt, IA, it was noted that house #(b)(4) was populated on or about September 26, 2010, with pullets that were never environmentally monitored. We acknowledge that, during the course of Inspection 4, you corrected your SE plan to call for pullet environment testing at 14-16 weeks.
• Your SE prevention plan for all five farms stated that environmental sampling of pullets is done at 12 weeks of age. Your written response dated May 25, 2011, stated that corrective actions were being implemented for all pullet flocks to be environmentally monitored between 14 to 16 weeks of age; however, FDA observed that the SE prevention plans of the farms that were subsequently inspected had not been revised to reflect this correction. We acknowledge that during Inspection 4 in Humboldt, IA, you corrected that farm's SE prevention plan in the presence of FDA investigators to call for pullet environment testing at 14-16 weeks.
• During Inspection 2 in Litchfield, MN, your records indicated that two of your poultry houses had been populated with pullets that were environmentally monitored when they were approximately 19 weeks of age. Your written response dated May 25, 2011, stated that you do not test any of your pullets at 19 weeks of age, and that pullets at this age are already at the layer facility. Your response seems to indicate that a recordkeeping error had been made. Under 21 CFR 118.10(a)(2), you must maintain records documenting that pullets were raised under SE monitored conditions, including environmental testing records for pullets.
7. You failed to maintain practices that will protect against cross-contamination when persons move between poultry houses as required by 21 CFR 118.4(b)(3). Specifically, during Inspection 1 in Goodell, IA, management stated that employees move between SE-positive houses and SE-negative houses without taking precautions that would prevent cross-contamination, and FDA investigators found that your SE prevention practices failed to address cross-contamination from personnel movement between poultry houses. Your written response dated May 18, 2011, stated that personnel working at Goodell will institute immediately a new series of steps to ensure all precautions have been taken to prevent cross-contamination between SE-positive and SE-negative houses including powder foot baths and hand sanitizers when exiting SE positive houses. You further stated that this correction had been included in the updated Goodell SE Prevention Program. We will verify this correction at our next inspection.
8. You failed to prevent stray poultry, wild birds, cats, and other animals from entering poultry houses as required by 21 CFR 118.4(b)(4).
• During Inspection 1 in Goodell, IA, a wild bird was observed in house #(b)(4) Bent, broken, or separated bird netting was observed in five of the poultry houses, and broken louvers were observed on ventilation fans in one house. Your written response dated May 18, 2011, stated that all bird netting to prevent the introduction of wild birds and all louvers on ventilation fans would be immediately repaired. We will verify these corrections at our next inspection.
• During Inspection 3 in Hudson, CO, a hole was observed in the bird netting located along the northwest corner eave of layer house #(b)(4) South. The hole measured approximately 48 inches in length and 24 inches in width. We acknowledge that the hole was repaired during the course of the inspection.
9. You failed to sample the environment using a sampling plan appropriate to the poultry house layout as required by 21 CFR 118.7(a). Specifically, at all five of your facilities you did not sample your manure pits, though they appeared to be accessible and were, in fact, accessed by FDA during Inspection 1 (Goodell, IA) and Inspection 2 (Litchfield, MN, where FDA's environmental sampling found the presence of SE, as discussed below). Instead of sampling your manure pits, you sampled (b)(4) Additionally, at Goodell, IA, you only sampled from the (b)(4) Your written response dated May 18, 2011, stated that Goodell's updated SE Prevention Program "has addressed the sampling method and follows FDA August 2010 guidelines and provided an optimal method in case manure sampling cannot be accomplished." We will verify this correction at our next inspection.
10. You failed to maintain records documenting rodent and other pest control measures as required by 21 CFR 118.10(a)(3)(ii). Specifically, during Inspection 3 in Hudson, CO, FDA investigators found that, as of May 9, 2011, you had not maintained any fly monitoring documentation. We acknowledge that your Production Manager stated that documentation began during the course of the inspection, and one monitoring log was provided. We will verify your continued compliance at our next inspection.
11. You failed to include the date and time of the activities reflected in your records, as required by 21 CFR 118.10(b)(2). Specifically, during Inspection 5 in Britt, IA, FDA investigators observed that your House Fly Activity Log, your Fly Control Logs, and your Rodent Index Monitoring Records did not document the times of the activities that the records reflect. We acknowledge that during the course of the inspection, you revised your House Fly Activity Log and your Fly Control Logs to include a space to record the time of the activity. We will verify your corrective actions at our next inspection.
12. You failed to provide the location of your farm on all of your required records, as required by 21 CFR 118.10(b)(1). Specifically, during Inspection 3 in Hudson, CO, records related to rodent monitoring and refrigeration monitoring did not contain the location of your farm.
13. You failed to include in your required records the signature or initials of the person performing the operation or creating the record, as required by 21 CFR 118.10(b)(3). Specifically, during Inspection 4 in Humboldt, IA, rodent monitoring logs did not have the signature or initials of the person performing the operation. Your written response dated July 12, 2011, stated that the Humboldt SE Prevention Program has made the appropriate correction for the Rodent Control Representative to initial or sign the monitoring records. We will verify this correction at our next inspection.
This letter is not intended to be an all-inclusive list of your firm's violations. 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 the applicable 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 FDA taking regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures under 21 CFR 118.12(a).
In addition to the above violations, we also have the following comments:
• Under 21 CFR 118.8(a), you must conduct testing to detect SE in environmental samples using the method entitled "Environmental Sampling and Detection of Salmonella in Poultry Houses," April 2008, or an equivalent method in accuracy, precision, and sensitivity in detecting SE. At the time of these inspections, your SE prevention plan for all five of your farms required environmental sampling in your high-rise style layer houses of (b)(4) with (b)(4). This method has not been recognized by FDA as being equivalent to the method entitled "Environmental Sampling and Detection of Salmonella in Poultry Houses," April 2008. We acknowledge that your latest written response dated July 12, 2011 (Humboldt, IA), states that the revised (July 1, 2011) version of your SE prevention plan calls for "appropriate FDA-approved sampling materials for environmental sampling procedures." If you are continuing to use a method that differs from the method specified in 21 CFR 118.8(a) and that has not been recognized by FDA as being equivalent to that method, we encourage you to submit documentation to FDA that will allow the agency to make a determination regarding equivalency.
• Additionally, FDA environmental sampling conducted at Litchfield, MN, (Inspection 2) indicated the presence of Salmonella enteriditis in poultry houses #(b)(4) We acknowledge that, upon being notified of these findings, you initiated egg testing in keeping with 21 CFR 118.6, the results of which have all been negative.
Within 15 working days of receipt of this letter, you should notify this office in writing of the specific steps that you have taken to correct the above violations and prevent their recurrence. Include an explanation of each step being taken to correct the violations and prevent their recurrence, as well as copies of related documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections.
Please send your reply to the Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the address in the above letterhead. If you have questions regarding any issues in this letter, please contact Ms. Wisecup at (612) 758-7114.
Sincerely,
/S/
Elizabeth A. Waltrip
Acting Director
Minneapolis District
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