Harold Brey & Sons Inc.

WARNING LETTER Harold Brey & Sons Inc. MARCS-CMS 585292 — September 24, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE Product: Food & Beverages Egg/Egg Product Recipient: Recipient Name Mr. Daniel Brey & Ms. Nancy Brey Recipient Title Co-Owners Harold Brey & Sons Inc. 607 Swiss Hill Road Jeffersonville , NY 12748 United States Issuing Office: Division of Human and Animal Food Operations East I 158-15 Liberty Avenue Jamaica , NY 11433 United States Sep 24, 2019 WARNING LETTER CMS # 585292 Dear Mr. & Ms. Brey: The United States Food and Drug Administration (FDA) inspected your shell egg farm, including your processing plant where eggs are cleaned and packaged, located at 607 Swiss Hill Road, Jeffersonville, NY, 12478 from May 21 through May 29, 2019. During the inspection, the investigators observed that you have serious violations of the Prevention of Salmonella Enteritidi s (SE) in Shell Eggs During Production, Storage, and Transportation regulation (the shell egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR Part 118). Failure to comply with the provisions of 21 CFR Part 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 (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 May 29, 2019. 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 received your response dated June 5, 2019, concerning our investigators’ observations issued to you at the close of the inspection. Our evaluation of your response is discussed below. Your significant violations are as follows: Your farm failed to conduct environmental testing for Salmonella Enteritidis (SE) in the poultry house when laying hens are 40 to 45 weeks of age, as required by 21 CFR 118.5(a). Specifically, Flock # (b)(4) was born on April 3, 2018, and Flock # (b)(4) was born on November 7, 2017.  At 40-45 weeks of age (January 8, 2019 through February 12, 2019 for Flock # (b)(4) and August 14, 2017 through September 18, 2017 for Flock # (b)(4) ), environmental testing should have been conducted, as required by 21 CFR 118.5(a); however, you failed to collect an environmental sample during this timeframe.  You indicated that a sample for Flock # (b)(4) was collected on March 9, 2019 when that flock was approximately 48-49 weeks of age, and you indicated that a sample for Flock # (b)(4) was collected on September 28, 2018, when the flock was approximately 46-47 weeks of age. Your response states that “The sampling date will be calculated based on the day of age of the birds to ensure compliance moving forward on every flock. When a new flock is placed on the farm, we will schedule the environmental testing at that time with reminders to ensure the testing is done within the required time frames to ensure compliance.”  We will verify the adequacy of your corrective actions during a future inspection. You failed to properly implement your written SE prevention plan as required by 21 CFR 118.4, and you failed to take the required number of samples for environmental testing using a sampling plan appropriate to the poultry house layout, as required by 21 CFR 118.7(a). The section titled “Environmental Testing” on pages 12 & 13 of your SE prevention plan, dated July 1, 2010, states “ (b)(4) .” On September 28, 2018, you only collected (b)(4) swabs for testing a poultry house environment that is (b)(4) feet in length with (b)(4) rows. (b)(4) swabs are inadequate for a poultry house of this size. For more information about environmental sampling, see Section III.B of Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation, December 2011, available at: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformati on/Eggs/ucm285101.htm Your response states that “I have retrained employees involved in the swabbing of the poultry house to follow the SE prevention plan and utilize (b)(4) swabs per row as indicated in our SE prevention plan and also on page 13 of the FDA guidance. This will be done by June 15, 2019.” You did not provide any records of this training.  We will verify the adequacy of your corrective actions during a future inspection. Your SE prevention plan failed to address when monitoring indicates unacceptable rodent activity within a poultry house, as required by 21 CFR 118.4(c)(1). Specifically, your monitoring procedures do not establish thresholds to determine acceptable or unacceptable rodent activity within a poultry house. Further, they do not detail what appropriate corrective actions are to be taken when rodent activity is deemed to be unacceptable to achieve satisfactory rodent control. In addition, during the inspection, our investigators observed two live rodents in layer house (b)(4) and 1 dead rodent in layer house (b)(4) . Your response states that “All employees with responsibility over rodent monitoring and indexing have been retrained on proper procedures as referenced on page 8 in the FDA guidance. We will double check & monitor all rodent activity in the buildings include outside rodent activity. Will make sure activity is accurate and the proper corrective actions are taken when necessary.” However, this does not address what appropriate corrective actions will be taken when rodent activity is deemed unacceptable.  Therefore, we are unable to fully assess your promised corrective actions.  We will verify the adequacy of your corrective actions during a future inspection.  In addition, we recommend assessing the hole that was observed in the south wall because it could be an ingress opportunity for rodents, and you have been operating without a rodent threshold. Additional Comments: Your SE Prevention Plan does not indicate when the cleaning will be done, e.g., after each flock or as required after a positive finding.  As required under 21 CFR 118.4(d), you should indicate that at a minimum you will conduct the cleaning and disinfecting procedures described at depopulation following finding of a positive environment of positive eggs.  In addition, the plan should list the types of disinfectants used. In your Biosecurity Plan, you indicate that the that equipment moved between “Farms” will be cleaned.  We would recommend revising the plan to say between “House,” as the shell egg regulation requires measures be taken to limit the introduction of SE into or among poultry houses. 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). Please notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific things that you are doing to correct the violations described above.  As stated above, your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence.  If corrective action cannot be completed within 15 working 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 that corrections have been made.  If you believe you have complied with FDA regulations, include your reasoning and any supporting information for our consideration. Please send your reply to the U.S. Food and Drug Administration, Attention: Michael R. Dominick, Compliance Officer, 222 Bloomingdale Road, Suite 406, White Plains, NY 10601.  If you have questions regarding any issues in this letter, please contact Michael R. Dominick at 914-682-2826 ext. 20 or email at Michael.Dominick@fda.hhs.gov . Sincerely, /S/ Ronald Pace Program Division Director, East Division 1 Office of Human and Animal Food Operations Content current as of: 10/08/2019 Regulated Product(s) Food & Beverages Egg/Egg Product