Inspections, Compliance, Enforcement, and Criminal Investigations
Rocky Ford Pet Foods 8/27/13 Department of Health and Human Services logoDepartment 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.gov1.
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
Enforcement Report - Week of February 20, 2013
Product Description Regular Chicken 50# Ingredients: Corn, Wheat, Oats, Oyster shells, Medium Grit, CCC, ADS, Plant Protein Products, Animal Protein Products, Processed Grain By-Products, Roughage Products, Animal Fat procession with DHA, etc
Recall Number V-137-2013
Classification Class III
Code Info 8/6/2012
Product Distributed Qty 5400lbs (50lb bags)
Reason For Recall During an FDA sample collection, the firms 50# Regular Chicken Feed was found to contain mammalian protein. The label does not contain the warning statement.
Event Id 63743
Product Type Veterinary
Recalling Firm Cohoons Elevator Inc.
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-21
Initial Firm Notification of Consignee or Public Other
Distribution Pattern Midland MI area only.
Thursday, June 6, 2013
BSE TSE PRION USDA FDA MAD COW FEED COMPLIANCE REPORT and NAI, OAI, and VAI ratings as at June 5, 2013
since our fine federal friends have decided not to give out any more reports on the USA breaches of the feed ban and surveillance etc. for the BSE TSE prion mad cow type disease in the USDA livestock, I thought I might attempt it. I swear, I just don’t understand the logic of the SSS policy, and that includes all of it. I assure you, it would be much easier, and probably better for the FDA and the USDA INC., if they would simply put some kind of report out for Pete’s sake, instead of me doing it after I get mad, because I am going to put it all out there. the truth.
PLEASE BE ADVISED, any breach of any of the above classifications OAI, VAI, RTS, CAN lead to breaches into the feed BSE TSE prion protocols, and CAN lead to the eventual suspect tainted feed reaching livestock. please, if any USDA official out there disputes this, please explain then how they could not. paperwork errors can eventually lead to breaches of the BSE TSE prion mad cow feed ban reaching livestock, or contamination and exposure there from, as well.
I would sure like to see the full reports of just these ;
4018 CHI-DO 3007091297 Rancho Cantera 2866 N Sunnyside Rd Kent IL 61044-9605 OPR FR, OF HP 11/26/2012 OAI Y
9367 3008575486 Rocky Ford Pet Foods 21693 Highway 50 East Rocky Ford CO 81067 OPR RE, TH HP 2/27/2013 OAI N
9446 DEN-DO 1713202 Weld County Bi Products, Inc. 1138 N 11th Ave Greeley CO 80631-9501 OPR RE, TH HP 10/12/2012 OAI N
9447 DEN-DO 3002857110 Weld County Bi-Products dba Fort Morgan Pet Foods 13553 County Road 19 Fort Morgan CO 80701-7506 OPR RE HP 12/7/2011 OAI N
see full list of the fda mad cow bse feed follies, toward the bottom, after a short brief update on the mad cow bse follies, and our good friend Lester Crawford that was at the FDA.
ALSO, I would kindly like to comment on this FDA BSE/Ruminant Feed Inspections Firms Inventory (excel format)4 format, for reporting these breaches of BSE TSE prion protocols, from the extensive mad cow feed ban warning letters the fda use to put out for each violations. simply put, this excel format sucks, and the FDA et al intentionally made it this difficult to follow the usda fda mad cow follies. this is an intentional format to make it as difficult as possible to follow these breaches of the mad cow TSE prion safety feed protocols. to have absolutely no chronological or numerical order, and to format such violations in a way that they are almost impossible to find, says a lot about just how far the FDA and our fine federal friends will go through to hide these continued violations of the BSE TSE prion mad cow feed ban, and any breaches of protocols there from. once again, the wolf guarding the henhouse $$$
NAI = NO ACTION INDICATED
OAI = OFFICIAL ACTION INDICATED
VAI = VOLUNTARY ACTION INDICATED
RTS = REFERRED TO STATE
Inspections conducted by State and FDA investigators are classified to reflect the compliance status at the time of the inspection, based upon whether objectionable conditions were documented. Based on the conditions found, inspection results are recorded in one of three classifications:
OAI (Official Action Indicated) when inspectors find significant objectionable conditions or practices and believe that regulatory sanctions are warranted to address the establishment’s lack of compliance with the regulation. An example of an OAI classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspectors will promptly re-inspect facilities classified OAI after regulatory sanctions have been applied to determine whether the corrective actions are adequate to address the objectionable conditions.
VAI (Voluntary Action Indicated) when inspectors find objectionable conditions or practices that do not meet the threshold of regulatory significance, but warrant an advisory to inform the establishment that inspectors found conditions or practices that should be voluntarily corrected. VAI violations are typically technical violations of the 1997 BSE Feed Rule. These violations include minor recordkeeping lapses or conditions involving non-ruminant feeds.
NAI (No Action Indicated) when inspectors find no objectionable conditions or practices or, if they find objectionable conditions, those conditions are of a minor nature and do not justify further actions.
when sound science was bought off by junk science, in regards to the BSE TSE prion mad cow type disease, by the USDA, CFIA, WHO, OIE, et al. $$$
when the infamous, and fraudulently USDA, FSIS, APHIS, FDA, gold card was taken away that infamous day in December of 2003, all cards were off the table, it was time to change the science, and change they did. ...tss
snip. ...please see full text ;
Thursday, June 6, 2013
BSE TSE PRION USDA FDA MAD COW FEED COMPLIANCE REPORT and NAI, OAI, and VAI ratings as at June 5, 2013
Friday, July 19, 2013
PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED Revised as of April 1, 2013 50# Regular Chicken Feed was found to contain mammalian protein label does not contain the warning statement
Tuesday, June 11, 2013
Weld County Bi-Products dba Fort Morgan Pet Foods 6/1/12 significant deviations from requirements in FDA regulations that are intended to reduce the risk of bovine spongiform encephalopathy (BSE) within the United States
Monday, August 27, 2012
Central Valley Meat Company: USDA Did its Job, OK?
Opinion & Contributed Articles
by Dr. Richard Raymond | Aug 27, 2012 Opinion
Dr. Richard Raymond former Undersecretary for Food Safety, U.S. Department of Agriculture (2005-2008)
Monday, August 26, 2013
The Presence of Disease-Associated Prion Protein in Skeletal Muscle of Cattle Infected with Classical Bovine Spongiform Encephalopathy
Monday, September 02, 2013
Atypical BSE: role of the E211K prion polymorphism
Research Project: TRANSMISSION, DIFFERENTIATION, AND PATHOBIOLOGY OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES
Location: Virus and Prion Research Unit
Sunday, September 1, 2013
Evaluation of the Zoonotic Potential of Transmissible Mink Encephalopathy
We previously described the biochemical similarities between PrPres derived from L-BSE infected macaque and cortical MM2 sporadic CJD: those observations suggest a link between these two uncommon prion phenotypes in a primate model (it is to note that such a link has not been observed in other models less relevant from the human situation as hamsters or transgenic mice overexpressing ovine PrP ). We speculate that a group of related animal prion strains (L-BSE, c-BSE and TME) would have a zoonotic potential and lead to prion diseases in humans with a type 2 PrPres molecular signature (and more specifically type 2B for vCJD)
Together with previous experiments performed in ovinized and bovinized transgenic mice and hamsters [8,9] indicating similarities between TME and L-BSE, the data support the hypothesis that L-BSE could be the origin of the TME outbreaks in North America and Europe during the mid-1900s.
Sunday, July 21, 2013
Welsh Government and Food Standards Agency Wales Joint Public Consultation on the Proposed Transmissible Spongiform Encephalopathies (Wales) Regulations 2013 Singeltary Submission WG18417
Saturday, September 21, 2013
Westland/Hallmark: 2008 Beef Recall A Case Study by The Food Industry Center January 2010 THE FLIM-FLAM REPORT
Tuesday, September 17, 2013
USAHA 116TH ANNUAL MEETING October 18 – 24, 2012 CWD, Scrapie, BSE, TSE prion (September 17, 2013)
Friday, August 16, 2013
*** Creutzfeldt-Jakob disease (CJD) biannual update August 2013 U.K. and Contaminated blood products induce a highly atypical prion disease devoid of PrPres in primates
Sunday, August 11, 2013
Creutzfeldt-Jakob Disease CJD cases rising North America updated report August 2013
*** Creutzfeldt-Jakob Disease CJD cases rising North America with Canada seeing an extreme increase of 48% between 2008 and 2010
Sunday, September 08, 2013
Iatrogenic Creutzfeldt-Jakob disease via surgical instruments and decontamination possibilities for the TSE prion
kind regards, terry