Recipient NameEarnest A. Mahard III
- Mahard Egg Farm, Inc. (Boogie Hill)
1996 Mahard Rd
Sulfur, OK 73086-8517
- Issuing Office:
- Dallas District Office
Food & Drug Administration
Dallas District Office
4040 North Central Expressway
Dallas, Texas 75204
April 26, 2017
Earnest A. Mahard III, Owner
Mahard Egg Farm, Inc.
1996 Mahard Rd.
Sulfur, Oklahoma 73086-8517
Dear Mr. Mahard:
From October 17, 2016 through October 18, 2016, investigators from the U.S. Food and Drug Administration (FDA) conducted an inspection of your shell egg farm located at 1996 Mahard Rd., Sulfur, Oklahoma 73086. During the inspection, the investigators observed that you 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). 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 FD&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. Our Investigators’ observations were noted on the FDA 483, Inspectional Observations, which was issued to you on October 18, 2016. 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.
We acknowledge receipt of your e-mail sent on November 3, 2016, as your response to the FDA 483, and have reviewed the contents and attachments provided. The FDA 483 response addresses observations at a different farm, and does not address observations specific to the Boogie Hill location. To date, we have not received a response specific to the observations included on the FDA 483 issued at the conclusion of the Boogie Hill inspection.
Your significant violations are as follows:
1. You failed to establish a poultry house environmental sampling plan that was appropriate to the poultry house layout, as required by 21 CFR 118.7(a). Specifically, your “Salmonella Enteritis Prevention Plan” (SE plan) for your Boogie Hill location states, “Due to insufficient space between the manure pit and the cage rows, manure samples may not be adequately collected. While manure is the preferred sample feeders and walkways may be sampled instead.”
Currently, manure collects directly below the cages in (b)(4) approximately (b)(4), which are reportedly (b)(4). The investigators also observed dry manure and dust on the inside wall of the manure pit as well as the metal support frame between cages. You stated that your current practice is to swab the (b)(4) or cages which are an estimated (b)(4). The investigators also observed that the feeders and cages do not come in direct contact with manure.
By swabbing the outside of the laying hen feeders and cages, you are not swabbing areas that come in contact with manure, and you are not swabbing the most probable Salmonella recovery areas. In addition, your SE plan references the possible use of a (b)(4) which is non-equivalent sampling technique in accordance with 21 CFR 118.8(a).
2. You failed to have biosecurity measures in your firm’s SE prevention plan or in your Quality Egg Biosecurity Plan (QEBS, undated) to ensure that there is no introduction or transfer of SE into or among poultry houses, as required by 21 CFR 118.4(b). Specifically, you failed to implement measures to prevent stray poultry, wild birds, cats, and other animals from entering poultry house (b)(4), as required by 21 CFR 118.4(b)(4). During the inspection, the investigators observed multiple signs of bird or rodent presence in and around the laying hens in house (b)(4). During the inspection, on October 17-18, 2016, our investigators observed the following:
a. An approximate 12 inch in diameter bird-like nest was observed along roof supports in the southeast part of house (b)(4). Additionally, multiple holes were observed in the roof in the same vicinity as the nest. Three of these holes were an estimated 1 – 2 inches in diameter. The nest and holes in the roof were located directly above cages holding laying hens.
b. An approximate 10 inch hole above the white feed line entering the northeast side of house (b)(4). This feed line extends down to the ground under the feed silo providing an avenue of ingress for animals.
c. Apparent rodent or animal holes dug into or under the exterior walls of house (b)(4). Specifically, a hole was observed adjacent to the sliding door on the northeast side of the house and in two places along the exterior of the north wall. Additionally, there was a hole dug into or under the foundation of the north wall of house (b)(4).
In addition, our investigators observed sheep feces directly outside non-populated houses which can be an attractant to flies and serve as potential harborage under 21 CFR 118.4(c)(3).
3. You failed to implement your written SE prevention plan that includes methods to monitor rodents, as required by 21 CFR 118.4(c)(1). Specifically, your written QEBS plan includes a map that identifies (b)(4) mechanical traps and states that “multi-use catch traps and bait stations will be positioned every (b)(4) feet inside and outside of barns”; however, on October 17-18, 2016 our investigators observed 4 mechanical traps around the exterior perimeter of house (b)(4), all of which were damaged. Further, you stated that neither rodent traps nor bait stations are maintained on the exterior of the houses because a flock of sheep have access to the perimeter of the poultry houses. You confirmed the presence of the sheep around the perimeter of the houses in the affidavit signed on October 18, 2016. The presence of sheep around the poultry house does not relieve you of the responsibility to manage and control rodent populations as outlined in your QEBS plan.
4. You failed to monitor for fly activity within the poultry house, as required by 21 CFR 118.4(c)(2). Specifically, the investigators reviewed your SE and QEBS plans and observed that they do not include preventative measures for fly control. Your QEBS plan states “The Boogie Hill facility is a (b)(4) facility with (b)(4) in place. There is no need for a Fly Control program at this location.” You confirmed the absence of a fly control program in the affidavit signed on October 18, 2016. The design of the facility and frequency of the manure pit flushing does not relieve you of the responsibility to monitor fly activity within your poultry houses.
5. You failed to maintain records demonstrating compliance with your SE and QEBS plans, as required by 21 CFR 118.10(a)(3)(ii). Specifically, your SE plan requires the monitoring of pests and corrective actions when thresholds are reached. Your firm’s QEBS plan identifies this record as “Rodent Monitoring Form Mahard Egg Farm, Chillicothe, Texas” and is intended to document the number of mice found in specific mechanical rodent traps (tin cats).
According to the “Pest Management” section of your firm’s QEBS plan “When more than (b)(4) mice are located in any one trap (or more than (b)(4) mice per barn) requires further inspection by a supervisor be scheduled”, in addition to further corrective actions to be taken and documented.
During the inspection, the investigators reviewed your rodent logs for August 3, 2015 to July 4, 2016 and observed the following dates where more than (b)(4) mice were observed in any one trap without corrective actions being documented:
• November 2, 2015: two traps contained 4 mice.
• November 17, 2015: one trap contained 5 mice.
• December 1, 2015: one trap contained 4 mice.
In addition, the investigators observed incomplete log entries on multiple dates (e.g., September 22, 2016 and October 4, 2016) and therefore could not determine if the number of mice exceeds your threshold of “25 mice per barn.”
Further, following the tin cat inspection, the logs are signed by the person conducting the inspection, and then later reviewed, signed, and dated by a reviewer. The investigators observed that all aberrant pest logs had been reviewed, signed, and dated without the inclusion of any corrective actions having been taken. Therefore, you are not following your QEBS plan in that corrective actions are not being documented, tin cat inspections are incomplete, and the review process does not ensure the pest management program is functioning in accordance with the plan.
We also note that your record “Rodent Monitoring Form Mahard Egg Farm, Chillicothe, Texas” does not include the location of your farm, as required by 21 CFR 118.10(b)(1).
The above violations are not meant 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 the responsibility to use procedures to prevent future 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 FDA taking regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures under 21 CFR 118.12(a).
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection- related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility.
You should notify this office in writing within fifteen (15) business days from your receipt of this letter of the specific steps you have taken to correct the noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long term corrective actions. If you cannot complete all corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies.
Please send your reply to the U.S. Food and Drug Administration addressed to Chad J. Whitwell, Compliance Officer, 4040 N. Central Expressway, Suite 300, Dallas, Texas, 75204. If you have questions regarding any issues in this letter, please contact Chad J. Whitwell at 214-253-5328.
Shari J. Shambaugh
Acting Dallas District Director
CC: Mr. Stan Stromberg
Food Safety Director
Oklahoma Agriculture Food and Forestry
PO Box 528804
Oklahoma City, Oklahoma 73152
CC: Lori Woznicki, Food and Drug Inspections Branch Manager
Division of regulatory Services
Texas Department of State Health Services
1100 E. 49th Street – Mail Code 1987
Austin, Texas 78756
CC: Earnest A. Mahard III, Owner
Mahard Egg Farm, Inc.
PO Box 248
Prosper, Texas 75078-0248