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- VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
- Animal & Veterinary
Food & Beverages
Recipient NameJared W. Fenske
Recipient TitleInterim General Manager
- Countryside Feed LLC
1972 State Highway 187
Seneca, KS 66538-2186
- Issuing Office:
- Office of Human and Animal Food West Division II
August 18, 2022
CMS # 633109
Dear Mr. Fenske,
The U.S. Food and Drug Administration (FDA) inspected your animal food manufacturing facility located at 1972 State Highway 187, Seneca, Kansas on April 11 through 22, 2022. The inspection was conducted as a follow-up to inspections conducted by the Kansas Department of Agriculture (KDA) in November 2021 and December 2021. The KDA inspections were conducted in response to consumer complaints regarding suspected copper poisoning from sheep food that resulted in multiple sheep deaths. A sample of your “Lamb Builder 16% Lamb Creep 80869” sheep food collected by KDA on November 19, 2021 and analyzed by the Nebraska Department of Agriculture contained an elevated level of copper at 31.0 parts per million (ppm), which is a level that would cause acute toxicity in sheep.1 The recognized maximum tolerable level of copper in food for sheep is 15 ppm on a dry matter basis, assuming normal concentrations of molybdenum and sulfur.2 The elevated level of copper found in your product named above causes it to be adulterated because such food reasonably may be fatal or injurious to the health of sheep.3 On November 19, 2021, you initiated a voluntary Class I recall of this animal food due to an excessive level of copper.
During FDA’s inspection, the Investigators found evidence of significant violations of the Hazard Analysis and Risk-Based Preventive Controls for Food for Animals requirements in Title 21, Code of Federal Regulations, Part 507 (21 CFR part 507) which cause your products to be adulterated.4 The doing of any act to a food after shipment of the food and/or its components in interstate commerce and while the food is held for sale (whether or not the first sale) that results in the food being adulterated or misbranded is prohibited.5 Furthermore, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls requirements of 21 CFR part 507 (located in subparts A, C, D, E, and F) is also a prohibited act.6 You may find the FD&C Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.
At the close of the inspection, you were issued a FDA Form 483, Inspectional Observations. We received your written responses dated May 12, 2022, and June 8, 2022, and address your corrective actions below.
Hazard Analysis and Risk-Based Preventive Controls Requirements
Your animal food facility is subject to the hazard analysis and risk-based preventive controls requirements found in 21 CFR part 507, subparts A, C, D, E, and F. During the inspection of your facility, the FDA Investigators noted evidence of significant violations of these requirements, which included but were not limited to the following:
1. Your facility failed to sufficiently assess the probability that a hazard will occur in the absence of preventive controls, as required by 21 CFR 507.33(c)(1).
Specifically, your reliance on your prerequisite program failed to reduce the probability that an elevated level of copper will occur in your animal food in the absence of a preventive control. You rely on your prerequisite programs of (b)(4) to manage the hazard of copper toxicity in food for sheep. However, your prerequisite program was not implemented in a way that reduces the probability of occurrence, as evidenced by your “Lamb Builder 16% Lamb Creep 80869” sheep food, which contained an elevated level of copper at 31.0 ppm. Moreover, during the inspection, our Investigators conducted a record review which found that you failed to implement these prerequisite programs on six (6) occasions by producing food for sheep without following your (b)(4) procedures prior to production. As a result of your failure to consistently follow your food safety plan, an excessive level of copper was found in your product and resulted in the recall described above. Therefore, you did not adequately reduce the probability that the hazard would occur in the absence of a preventive control.
In your written responses to the Form FDA 483, you provided a Sheep Formula Manufacturing and (b)(4) Procedure with a training attendance sheet, dated May 11, 2022; (b)(4); and sheep feed and ingredient copper testing results from a third-party laboratory, dated May 27, 2022. You also state you will implement a new Excel (b)(4) and Reporting Tool by June 30, 2022, and complete a (b)(4) upgrade by July 31, 2022. We are unable to evaluate your corrective actions since the documents you provided are blank templates and do not demonstrate the promised corrections have been implemented. We encourage you to provide documentation to show these corrections, as well as any updates to your planned actions to implement a new Excel (b)(4) and Reporting Tool and (b)(4) upgrade, have been completed.
2. You did not conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 507.33(a). Specifically:
A. You did not identify the known or reasonably foreseeable hazards of fumonisin and deoxynivalenol (DON or vomitoxin) for all grains and their co-products you receive and use as ingredients at your facility that are susceptible to fumonisin and vomitoxin. Also, you did not evaluate the severity of the illness or injury if the hazards were to occur, or the probability that the hazards would occur in the absence of preventive controls, to determine whether the hazards require a preventive control.
Furthermore, your “Aflatoxin Testing Procedure” only includes steps for sampling and testing of corn and does not include steps for other grains and grain co- products you receive, store, and use as ingredients at your facility.
B. Your hazard analysis identifies and evaluates “mycotoxins” at the ingredient receiving step. However, it does not account for the known or reasonably foreseeable hazard of mycotoxin development during storage at your facility.
Your written responses acknowledge that your firm’s hazard analysis and procedures were not sufficient to address all the hazards associated with mycotoxins. You further state that you are in the process of updating your hazard analysis and developing and implementing a testing program. We are unable to fully evaluate your corrective actions since you did not provide adequate supporting documentation to demonstrate the promised corrections have been completed and/or implemented. Additionally, the documentation you provided only indicates you have purchased testing equipment for aflatoxins and does not address our concerns with your lack of fumonisin and vomitoxin testing. We encourage you to provide documentation to show these changes have been made once completed.
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address this matter may lead to legal or regulatory action, including without limitation, seizure and injunction.
For more information about FDA’s current thinking on the requirements of 21 CFR part 507, see:
- Guidance for Industry #235: “Current Good Manufacturing Practice Requirements for Food for Animals” https://www.fda.gov/media/97464/download
- Guidance for Industry #245: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals” https://www.fda.gov/media/110477/download
- Guidance for Industry #246: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply Chain Program” https://www.fda.gov/media/113923/download
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.
Please send your firm’s response to Danial S. Hutchison, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Dr., Suite 205, Lenexa, KS 66214. If you have any questions about this letter, please contact Compliance Officer Hutchison at 913-495-5154.
LaTonya M. Mitchell, Ph.D.
Program Division Director
Office of Human and Animal Foods
West Division II
1 The Mineral Tolerance of Animals (National Research Council of the National Academies, Second Revised Ed. 2005).
2 The Mineral Tolerance of Animals (National Research Council of the National Academies, Second Revised Ed. 2005).
3 See Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(a)(1)].
4 See Section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)] and 21 CFR 507.1(a)(1)(ii).
5 See Section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].
6 See Section 301(uu) of the FD&C Act [21 U.S.C. § 331(uu)].