Inspections, Compliance, Enforcement, and Criminal Investigations
Rocky Ford Pet Foods 8/27/13
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
August 27, 2013
VIA UPS Overnight
Mr. Juan Manuel Villegas
Rocky Ford Pet Foods
21693 Highway 50 East
Rocky Ford, CO 81067
Ref. #: DEN-13-20-WL
Dear Mr. Villegas:
On February 25-27, 2013, the U.S. Food and Drug Administration (FDA) conducted an inspection of your rendering facility located at 21693 Highway 50 East, Rocky Ford, Colorado. This inspection revealed significant deviations from the requirements set forth in FDA regulations 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 (21 CFR 589.2000), Animal Proteins Prohibited in Ruminant Feed, and Section 589.2001 (21 CFR 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; and
- The entire carcass of cattle 30 months of age or older that have not been inspected and passed for human consumption if the brains and spinal cords were not removed or otherwise effectively excluded from animal feed.
Your facility processes 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 implementing regulations on the Internet through links on the FDA’s web page at www.fda.gov.
Our inspection revealed the following serious deviations from the regulations at your rendering facility:
- Failure to prevent the inclusion of cattle materials prohibited in animal feed (CMPAF) in animal feed or feed ingredients, as required by 21 CFR 589.2001(c)(1). Specifically, on February 25, 2013, our investigator observed that the unmarked CMPAF posterior sections of vertebral columns for two cows, identified by your firm as older than 30 months of age, were separated from the rest of the marked CMPAF material from those animals. The unmarked CMPAF material was then commingled with 18 additional posterior vertebral columns and placed in a trailer for shipment to another renderer for further processing and possible use in animal feed.
You removed all 20 posterior vertebral columns from the trailer during the inspection and stated that you would dispose of them in a landfill.
- Failure to maintain adequate written procedures specifying how the process of removing the brain and spinal cord from cattle not inspected and passed for human consumption or 30 months of age or older is carried out, as required by 21 CFR 589.2001(c)(2)(ii). Specifically, your written procedure “Rocky Ford Ped [sic] Food Standard Operating Procedure for handling 30 month and older Beef and CMPAF Products” indicates that the head, vertebral column, and rib cage for cattle 30 months of age and older are kept in one piece. This written procedure is not consistent with actual operations observed at your firm on February 26, 2013. Our investigator observed that posterior vertebral columns from two cows 30 months of age or older were separated from the animals’ heads and anterior vertebral columns; the posterior sections were not marked as CMPAF material. Your written procedures fail to specify how, for animals 30 months of age or older, posterior vertebral columns separated from marked anterior vertebral columns would themselves be marked as CMPAF material.
- Failure to mark the CMPAF and products that contain or may contain CMPAF with an agent that can be readily detected on visual inspection, as required by 21 CFR 589.2001(c)(2)(v). Specifically, the posterior sections of vertebra columns from cattle identified by your firm as 30 months of age or older were separated from the head and anterior vertebral columns but then were not identified as CMPAF with an agent readily detectable on visual examination. Therefore, the CMPAF posterior vertebral columns were indistinguishable from the non-CMPAF posterior vertebral columns.
- Failure to label containers, including vehicles when used as containers, which contain CMPAF with the required statement, “Do not feed to animals,” as required by 21 CFR 589.2001(c)(2)(iv). Specifically, the dump truck and trailer used for storage and transport of CMPAF materials did not bear the statement “Do not feed to animals.”
- Failure to avoid cross-contamination once CMPAF have been separated from other cattle materials as required by 21 CFR 589.2001(c)(2)(iii). Specifically, both marked and unmarked CMPAF were observed to be stored on the floor of the processing area rather than in separate containers that adequately prevent contact with animal feed, animal feed ingredients, or equipment surfaces, 21 CFR 589.2001(c)(2)(iii)(B). As described in item #1 above, the unmarked materials were indistinguishable from non-CMPAF materials and could result in cross-contamination.
This letter is not intended to serve as an all-inclusive list of violations at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring your overall operation and the products you manufacture and distribute are in compliance 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.
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 supporting documentation demonstrating that corrections have been made.
Your written response should be sent to: U.S. Food and Drug Administration, P.O. Box 25087, 6th Ave. and Kipling St., DFC, Bldg 20, Denver, CO 80225-0087, Attn: Sarah A. Della Fave, Compliance Officer. If you have any questions about this letter, please contact Ms. Della Fave at (303) 236-3006.
cc: Ronald K. Jones, D.V.M.
Denver District Manager
PO Box 25387
DFC, Bldg 45
Denver, CO 80225
Colorado Department of Agriculture
2331 W. 31st Avenue
Denver, CO 80211