- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Animal & Veterinary
Food & Beverages
Recipient NameMark C. Haverkamp
- Valley View Milling LLC
2875 State Highway 63
Seneca, KS 66538-2145
- Issuing Office:
- Office of Human and Animal Food- West Division II
May 17, 2022
CMS # 626198
Dear Mr. Haverkamp,
The U.S. Food and Drug Administration (FDA) inspected your animal food manufacturing facility located at 2875 State Highway 63, Seneca, Kansas, on December 7 through 16, 2021. The inspection was conducted as a follow-up to complaints received by the Kansas Department of Agriculture (KDA) of copper poisoning from food for sheep resulting in the death or injury to a number of sheep. The KDA collected a sample of your “Custom Ewe Feed ClariFly” medicated feed and had it analyzed by the Nebraska Department of Agriculture Laboratory. The sample was collected from five closed bags of food for sheep found at a farm where the customer had experienced sheep death and injury. Analytical results from the KDA sample identified elevated levels of copper at 155.6 parts per million (ppm), which is a level that would cause acute toxicity in sheep. 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.1 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.2 On December 8, 2021 you initiated a voluntary Class 1 recall of this food and two other food products for sheep due to excessive levels of copper.
During our inspection, the FDA Investigator found evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements, Title 21, Code of Federal Regulations, Part 507 (21 CFR part 507) which also cause your products to be adulterated.3 The introduction or delivery for introduction into interstate commerce of any food that is adulterated or misbranded is a prohibited act.4 Furthermore, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of 21 CFR part 507 (located in subparts A, C, D, E, and F of Part 507) is also a prohibited act.5 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 Form FDA 483, Inspectional Observations (FDA 483). We acknowledge your written response dated December 24, 2021. We have reviewed your response 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 Investigator noted evidence of significant violations of these requirements, which included the following:
1. Your facility failed to sufficiently assess the probability that a hazard will occur in the absence of a preventive control, as required by 21 CFR 507.33(c)(1).
a. While your firm has prerequisite programs of (b)(4) to manage the hazard “copper toxicity in sheep” (excessive copper in food for sheep), and drug carryover in other feeds, you failed to implement these prerequisite programs. During the inspection our Investigator conducted a record review that revealed six occasions where you produced food for sheep without following your (b)(4) procedures prior to their production. In addition, during review of your records, the Investigator observed that on one occasion you produced a food for horses following a medicated cattle feed containing (b)(4) without (b)(4) prior to its production. Horses are acutely sensitive to (b)(4), and death can be a result of consumption.
As a result of your failure to follow your food safety plan, the excessive copper hazard and the drug carryover hazard were not adequately managed. Therefore, you did not adequately reduce the probability that the hazards would occur in the absence of preventive controls. As a result of your failure to consistently implement your prerequisite programs, you produced adulterated food for sheep, as described above.
Your email response, dated December 24, 2021, acknowledges that you failed to follow your product (b)(4) prerequisite programs. You stated in your response that you are refining your system to better allow for the proper (b)(4) of feeds and are in the process of retraining employees in the proper (b)(4) of feeds. We are unable to fully evaluate your corrective actions since you did not provide supporting documentation to demonstrate the promised corrections have been completed or implemented. We encourage you to provide documentation to show these changes have been made, once completed.
b. Your food safety plan includes a prerequisite program to manage aflatoxin in corn. Specifically, your plan states that you know where the regular corn you receive is being produced and that you watch all mycotoxin reports from feed and grain, grain journals, or other sources to make sure you are not in an outbreak area. It also states you keep close watch on weather conditions as certain conditions are more favorable for mycotoxins. It further states that when weather conditions are favorable for mycotoxin growth, you will do (b)(4) on regular corn loads from producers. The food safety plan says you (b)(4). The FDA investigator determined that all testing is limited to aflatoxins.
Relying solely on the above prerequisite program may result in a failure to address the occurrence of mycotoxin hazards. Without regular, adequate testing, the program does not adequately reduce the probability of mycotoxin presence upon receipt of the regular corn and during storage for both regular and organic corn, in the absence of preventive controls. Considering that you manufacture food for aflatoxin-sensitive animals, such as chickens, horses, and immature animals, a robust prerequisite program, consistently implemented, would be an important element of your food safety plan.
Your December 24, 2021, email response stated you were going to (b)(4) on the corn coming into the mill to make sure you are monitoring mycotoxin levels (b)(4). Your response was not specific as to whether you will be sampling only loads of corn on a (b)(4) basis and will not be sampling other grains and their co-products. Also, your response is not specific as to whether the (b)(4) sampling will consist of only one load of corn, one load of corn from each supplier, or a comingled sample from all loads of corn. We are unable to fully evaluate the adequacy of your corrective actions since your response does not include sufficient details. Your promised corrections will be verified during subsequent follow-up inspections.
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, you did not adequately identify and evaluate the known or reasonably foreseeable hazards of fumonisin and Deoxynivalenol (DON or vomitoxin) for all grains and their co-products used as ingredients at your facility that are susceptible to fumonisin and vomitoxin, Furthermore, you did not adequately identify and evaluate the known or reasonably foreseeable hazards of aflatoxin in grains and grain co-products used as ingredients at your facility that are susceptible to aflatoxin. Your hazard analysis identifies and evaluates “mycotoxins”—clarified during the inspection to be aflatoxin only—in corn (regular and organic) only. Furthermore, your hazard evaluation does not take into account the possibility of mycotoxin development during storage at your facility.
In your email response, dated December 24, 2021, you acknowledge that all mycotoxins had not been evaluated for all grains and grain by-products. You stated in your response that you are in the process of determining how to best address this. We encourage you to provide us with documentation of any changes, which will be examined during subsequent inspections.
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 you comply 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 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”
• Draft Guidance for Industry #245: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals”
• Draft Guidance for Industry #246: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply Chain Program”
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
CC: Ken Bowers, Feed Specialist
Dairy and Feed Safety
Kansas Department of Agriculture
1 The Mineral Tolerance of Animals (National Research Council of the National Academies, Second Revised Ed. 2005)
2 See Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(a)(1)].
3 See Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(a)(4)] and 21 CFR 507.1(a)(1)(ii).
4 See Section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
5 See Section 301(uu) of the FD&C Act [21 U.S.C. § 331(uu)].