Inspections, Compliance, Enforcement, and Criminal Investigations
Sunnyside Poultry Farms 11/28/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707
November 28, 2011
Return Receipt Requested
Donald E. Lippy, Vice President
Sunnyside Farms, Inc.
695 Bachman’s Valley Rd.
Westminster, MD 21157
Dear Mr. Lippy:
The United States Food and Drug Administration (FDA) inspected your shell egg production facility located at 695 Bachman’s Valley Rd, Westminster, MD on June 28 – July 11, 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). 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 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 may find the FD&C 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 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, your firm’s written Salmonella enteritidis prevention plan specifies that rodents will be kept at an index of 1 or below. However, a review of your firm’s records from July 2010 to June 2011 indicated several dates where the rodent index for multiple houses was at 2 or 3. During the inspection, Investigators observed evidence of rodent activity, such as burrows in the manure piles and a few live mice in and around the manure pits. Your written response dated July 18, 2011, stated that you will install a metal ledge where the wall and base of each fan box meet in order to eliminate rodent entry points and will change certain mouse baits in your inventory to ones that are more palatable to the mice in the area surrounding the farm. While this corrective action is one element in achieving satisfactory rodent control, FDA finds that the proposed correction alone may not provide consistent rodent control at your firm.
2. You failed to use appropriate methods to achieve satisfactory fly control when your own monitoring indicated unacceptable fly activity, as required under 21 CFR 118.4 (c)(2). Specifically, your firm’s SE prevention plan documents that weekly fly counts obtained using the sticky tape method will be kept at (b)(4) flies or less. A review of your firm’s fly control records from July 2010 to June 2011 documented several dates where the fly count was above 100 in all four of your poultry houses. Your written response dated July 18, 2011, stated that you are using new insecticides for fly control that seem to have a greater effect with quicker results. You also stated that you will implement reduction procedures when fly sticky strip numbers begin to increase prior to reaching the threshold of 100 flies. FDA will verify this correction at the next inspection.
3. You failed to obtain the results of egg testing within 10-calendar days of receiving notification of a positive environmental test, as required under 21 CFR 118.5(b)(2)(ii). Specifically, you received notification of a positive environmental sample for SE on January 18, 2011. After which your firm collected the first of four egg tests on January 24, 2011. The results of this egg test were provided to you by the laboratory on February 18, 2011, thirty-one days after your firm received notification of the positive environmental test for SE. Your written response dated July 18, 2011, stated that your firm’s eggs are tested by (b)(4), the (b)(4), and that (b)(4) was using a time consuming protocol to test eggs. Your response also states that (b)(4) encountered scheduling difficulty which led to a lengthy wait for test results. According to your written response, (b)(4) is now using PCR protocols for testing of egg pools and the testing is much quicker which has resulted in a better turn-around time for results to fit within the FDA timeframes. FDA will verify this correction at the next inspection.
4. You failed to review and make any necessary adjustments to your written SE prevention plan to ensure that all measures were being properly implemented, as required under 21 CFR 118.5(b)(2)(i). As previously noted, on January 18, 2011 you were notified of the positive SE environmental sample in House 2. However, your firm did not review and make changes to its written SE prevention plan. Your written response dated July 18, 2011, stated that you have implemented an SE vaccination program on all future replacement pullets for Sunnyside Farms that includes 2 killed SE injections and also you will be boosting with live SE on an 8 week basis. While FDA encourages the use of SE vaccines if individual producers have identified vaccines that are effective at their particular farms, FDA does not consider vaccination an appropriate corrective action.
There is considerable variation in the efficacy of vaccines and FDA has found SE positive environments and eggs in SE vaccinated flocks. Vaccines should only be viewed as an additional prevention measure and should not be viewed as substituting any of the SE preventive measures required in 21 CFR 118. SE vaccines are only effective when they are one piece of a comprehensive SE control plan.
5. You do not maintain practices that will protect against cross contamination when equipment is moved among poultry houses, as required under 21 CFR 118.4(b)(2). Specifically, during the inspection your farm manager, (b)(6) and a farm technician, Mr. R Nissley, informed Investigators that hand tools are shared and not sanitized between houses, even when one of the houses is known to have a positive environmental test for SE. Your written response dated July 18, 2011, stated that you have changed your SE prevention plan to reflect that maintenance equipment and tools will be cleaned and spayed with disinfectant upon exiting an SE positive house. FDA will verify this correction during the next inspection.
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 FD&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.
In addition to the above violations, we also have the following comment. During the inspection Investigators observed employees using compressed air to blow their clothes after having been in a poultry house. Your employees do not wear special shoes or clothing while working in poultry houses regardless of the SE status of the house. FDA recommends that compressed air not be used to blow employee clothing as Salmonella enteritidis can be spread via the airborne route. The use of compressed air by employees to blow their clothes between houses may actually serve to exacerbate the spread of SE rather than serve as a practice to minimize its spread. The procedures to protect against cross contamination when people move among poultry houses described in your written response dated July 18, 2011, do not reflect the use of compressed air to blow employee clothes and appear to be adequate.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you have done or plan to do to correct these violations and prevent their recurrence. You should include in your response documentation and other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and the time within which the remaining corrections will be completed.
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).
Please send your reply to the Food and Drug Administration, Attention: Deborah Gillis-Landrum, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have questions regarding any issues in this letter, please contact Ms. Gillis-Landrum at 410-779-5415 or via e-mail at Deborah.email@example.com.