Inspections, Compliance, Enforcement, and Criminal Investigations
Weld County Bi-Products dba Fort Morgan Pet Foods 6/1/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
June 1, 2012
Mr. Stephen K. Ulrich
Ms. Lonna A. Ulrich
Weld County Bi-Products, Inc.
1138 N. 11th Ave.
Greeley, CO 80631
Ref. #: DEN-12-16-WL
Dear Mr. and Ms. Ulrich:
Investigators from the U.S. Food and Drug Administration (FDA) conducted inspections of your rendering facility located at 1138 North 11th Avenue, Greeley, Colorado (Greeley Facility) from April 29 to May 9, 2011, and from November 1 to 3, 2011. FDA also conducted inspections of your rendering facility doing business as Fort Morgan Pet Foods, located at 13553 County Road 19, Fort Morgan, Colorado (Fort Morgan Facility) from June 14 to 17, 2011, and from December 5 to 7, 2011.
These inspections revealed significant deviations from requirements in FDA regulations that are intended to reduce the risk of bovine spongiform encephalopathy (BSE) within the United States. These regulations are found in Title 21 of the Code of Federal Regulations (CFR), section 589.2000 (Animal proteins prohibited in ruminant feed) and section 589.2001 (Cattle materials prohibited in animal food or feed to prevent the transmission of bovine spongiform encephalopathy). These regulations address how renderers process (1) mammalian proteins prohibited from use in ruminant food or feed, and (2) materials designated as “cattle materials prohibited in animal food or feed” (CMPAF) which are prohibited from use in animal food or feed. CMPAF include, but are not limited to:
- The brain and spinal cord of cattle 30 months of age or older
- The entire carcass of cattle infected with BSE
- The entire carcass of cattle 30 months or older that have not been inspected and passed for human consumption if the brains and spinal cords were not effectively removed or otherwise effectively excluded from animal feed
Your facilities process CMPAF.
Your failure to follow certain requirements of these regulations as described below resulted in products manufactured and distributed by your facilities being adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. § 342(a)(4)] and misbranded within the meaning of Section 403(f) of the Act, [21 U.S.C. § 343(f)]. You can find the Act and its associated regulations on the Internet through links on the FDA’s web page at www.fda.gov.
Adequate Written Procedures
Because your facilities (1) remove the brain and spinal cord from cattle not inspected and passed for human consumption and (2) separate cattle not inspected and passed for human consumption that are 30 months of age or older as a means of ensuring that CMPAF are not introduced into animal food or feed, you must maintain adequate written procedures specifying how these processes are carried out, 21 CFR § 589.2001(c)(2)(ii). Your written procedures are not adequate. Specifically, the hand-written document you supplied to us explaining your procedures for the removal and handling of CMPAF at the Greeley Facility was illegible, and did not completely describe the process of removing, segregating, documenting and disposing of CMPAF at the firm. This document did not explain who would do the work, how it would be done, how the CMPAF would be segregated, what equipment would be used, and how the equipment would be cleaned. At the Fort Morgan Facility, the document titled “Our plan of action to determine age of carcass and dispose of all carcasses 30 months of age and older” explains that your employees have been trained how to age cattle, and that cattle found to be 30 months of age or older are tagged with a (b)(4), but it also lacks information on how removal of the CMPAF would be done, how the material will be segregated, what equipment would be used, and how the equipment would be cleaned.
FDA regulations require that you establish, maintain, and make available to FDA for inspection and copying records sufficient to track CMPAF to ensure such material is not introduced into animal feed, 21 CFR § 589.2001(c)(2)(vi). At the Greeley Facility, the only documentation you provided to FDA was a hand-written notebook documenting the date and number of cattle over 30 months of age received at your firm. You did not have documentation to demonstrate that CMPAF is disposed of in a manner to prevent it from entering animal feed. At your Fort Morgan facility, you were using a dry-erase board to track cattle and their CMPAF on a daily basis, but there was not a system in place to save this information or allow for the review and copying of records from days prior to the current day to ensure CMPAF was not introduced into animal feed. We note that on December 5, 2011, the manager of your Fort Morgan firm did provide FDA with copies of a new document, which she indicated, would be used to ensure CMPAF is not introduced into animal feed. We will evaluate how well the new record works at our next inspection.
Once CMPAF has been separated from the cattle materials that may be used in feed, 21 CFR § 589.2001(c)(2)(iii) requires the use of measures to avoid cross-contamination, including using separate containers that adequately prevent contact between CMPAF and animal feed, animal feed ingredients, or equipment surfaces. FDA investigators observed that not all of the containers used to hold CMPAF could be differentiated from containers used to hold material that may be used for feed. This lack of differentiation can create confusion and thus does not adequately prevent CMPAF contact with material that may be used in animal feed. At your Fort Morgan facility, a white container used to store CMPAF was observed without any marking to make clear that it is used for CMPAF. At your Greeley facility, FDA investigators observed that neither the truck used to store CMPAF before delivery to the landfill nor a gray bucket in the head-splitting room used to store removed brains from cattle 30 months of age and older were marked to make clear that they were used to store CMPAF. At the close of the November 3, 2011 inspection at the Greeley facility, you indicated that you had added markings to the gray bucket and truck.
Ruminant Feed Caution Statements
At your Greeley Facility the shrink-wrapped pallets of frozen inedible beef to be shipped for further processing into animal feed were not labeled with the “Do not feed to cattle or other ruminants” caution statement required by 21 CFR § 589.2000(c)(1)(i).
This letter is not intended to serve as an all-inclusive list of violations at your facilities. As a manufacturer of materials intended for use in food for animals, you are responsible for ensuring your overall operation and the products you manufacture and distribute comply with the law. You should take prompt action to correct these violations, and you should establish a system whereby violations do not recur. Failure to promptly correct these violations may result in regulatory action, such as seizure and/or injunction, without further notice.
As a final matter, the regulation at 21 CFR § 559.2001(c)(2)(v) states that CMPAF and products that contain or may contain CMPAF must be marked with an agent that can be readily detected on visual inspection. Investigators observed at both facilities that you are currently using charcoal to both mark material that needs to be handled as CMPAF, and to decharacterize the animal tissue being harvested and frozen for distribution to a feed manufacturer for further processing. We would like to clarify the discussion you had with the investigators on this topic, and advise you that you should use a different agent to mark the product that must go to disposal than you use to decharacterize product that will be further processed into animal feed so these products may be easily differentiated and not inadvertently confused or commingled.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. 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 fifteen (15) working days, state the reason for the delay and the timeframe within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to: William H. Sherer, Compliance Officer, U.S. Food and Drug Administration, P.O. Box 25087 (6th Ave. and Kipling St., DFC, Bldg 20), Denver, CO 80225-0087. If you have any questions about this letter, please contact Mr. Sherer at (303) 236-3051, or by email at email@example.com.
LaTonya M. Mitchell
Denver District Director
Ms. Rebecca A. Jones
Weld County Bi-Products
13553 County Road 19
Fort Morgan, CO 80701
Ronald C. Nelson, D.V.M.
Denver District Manager
PO Box 25387
DFC, Bldg 45
Denver, CO 80225