Mahard Egg Farm, Inc. (Boogie Hill) FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

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 Fed

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.”

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:

Potential Health Risks

CC: Lori Woznicki, Food and Drug Inspections Branch ManagerDivision of regulatory ServicesTexas Department of State Health Services1100 E. 49th Street – Mail Code 1987Austin, Texas 78756

Regulatory Context

Your significant violations are as follows:

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).