Assessment of the Equivalence of the Canadian Beef Inspection System
Last year, my testimony discussed OIG's findings from our audit of APHIS' oversight of the importation of beef products from Canada. Our work on that audit led us to conduct an evaluation of FSIS' assessment of the equivalence of the Canadian food safety inspection system, which we issued in December 2005.
The then FSIS Administrator and the Under Secretary for Food Safety had identified concerns with the Canadian inspection system in late 2003. Our audit determined that FSIS did not fully address the issues raised by USDA officials in a timely manner. For example, in July 2003 FSIS found that Canadian inspection officials were not enforcing certain pathogen reduction and HACCP system regulations. These same types of concerns were identified again in June 2005.
At the time of our audit, FSIS did not have protocols for evaluating deficiencies in a foreign country's inspection system which could be used to question the system's equivalence to U.S. standards. In addition, FSIS had not instituted compensating controls (such as increased port-of-entry testing) to strengthen public health protections while
7
deficiencies were present. During the period of January 2003–May 2005, 4.4 billion pounds of Canadian processed product entered the U.S., even though FSIS officials questioned the equivalence of the Canadian inspection system.
FSIS agreed with OIG's five recommendations, which included implementing protocols to determine which deficiencies would lead FSIS to question whether a foreign country's inspection system is equivalent to the U.S. system. In response to the report, FSIS committed to develop these protocols by March 2006 and to implement them immediately thereafter.
Oversight of FSIS Recalls
For the past several years we have testified about our continuing work regarding adulterated beef product recalls. In July 2004, a Pennsylvania firm initiated a recall of approximately 170,000 pounds of ground beef patties because of mislabeling. Approximately one-fourth of this product was made, in part, from beef trim from Canada which was not eligible for import to the U.S., following the detection of a Canadian cow with BSE. In May 2005, we reported on the adequacy of FSIS' effectiveness checks and the agency's oversight of the recall. Overall, we concluded that FSIS had strengthened its procedures regarding the agency's oversight of recalls. However, we noted that FSIS personnel did not determine the amount of product purchased by firms on 26 of the 58 completed effectiveness checks. This resulted in reduced assurance that mislabeled product was completely retrieved from distribution. Agency officials concurred with the firms' assertions that the product had been removed from the marketplace. In response to
8
our recommendations, FSIS agreed to provide more specific direction to its personnel on identifying and evaluating the amount of product purchased.
The Subcommittee has been interested in OIG's investigation of a Pennsylvania company's recall of meat products. This remains an ongoing civil fraud investigation and we will be pleased to provide information on its resolution to the Subcommittee upon its conclusion.
http://appropriations.house.gov/_files/FongTestimony.pdf
2005
Coordination between USDA Agencies Necessary for Effective Protection of Food Safety, Public Health, and Agriculture Trade. In our August 2004 audit review of the Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase I, we reviewed the BSE plan in place and the plans for the expanded program. We made 19 recommendations to address limitations in the surveillance plan, make full disclosure of assumptions, and better define the animal population to be tested. Agreement on the recommendations was achieved at report issuance. Although many steps are being taken to improve the BSE surveillance program, the Animal and Plant Health Inspection Service (APHIS) and the Food Safety and Inspection Service (FSIS) need to closely coordinate their activities to protect the safety of our food supply and agriculture markets.
4
In February 2005, we reported that from August 2003 to April 2004, APHIS officials allowed a gradual expansion in the types of Canadian beef products approved for import into the United States. Additionally, APHIS allowed an expansion in the type of Canadian facilities that would be allowed to produce items for export to the United States. However, FSIS and APHIS did not always communicate effectively about the eligibility status of products imported, which resulted in ineligible product being brought into the United States. APHIS and FSIS agreed with the report's recommendations.
In September 2004, we initiated an audit to evaluate whether USDA enforcement of the ban on specified risk materials in meat products, the administration of its testing program, and the controls to prevent central nervous system (CNS) tissue in advanced meat recovery product have been effectively implemented to reduce the public health risk, provide consumer protection, and monitor the success of adopted prevention and control measures. We also started an audit to evaluate whether the newly expanded BSE Surveillance Program is accomplishing its intended objectives and has been effectively implemented and administered.
DEPARTMENTAL/AGENCY ACCOMPLISHMENTS/PLANS: In carrying out their mandate, RMA and FSA have established a working group to develop a comprehensive information management system (CIMS), which will combine the agencies' separate program data (e.g., acreage, type of crop, producer, past claims, etc.). In addition to developing an integrated comprehensive information management system, this effort has included re-defining data common to, and needed by, both agencies and data unique to each agency and developing a common format for such data. In the long term, NRCS will be invited to participate in CIMS. The success of this effort will critically depend on a unified, integrated approach to information collection and systems development.
APHIS agreed that additional discussion and clarification of the BSE surveillance program objectives and assumptions would contribute to public understanding of its efforts. Both FSIS and APHIS have issued instructions to field personnel that clearly state the policy to sample all cattle condemned on ante mortem inspection (except veal calves condemned for non-CNS reasons). Personnel in both APHIS and FSIS have been trained on the sample collection process. The APHIS and FSIS Administrators signed a Memorandum of Understanding on July 6, 2005, relative to cooperation in surveillance programs.
For research misconduct, the Department agreed, as recommended in our report, that a centralized body for implementing a research misconduct policy will be established within the Department. The office of the Under Secretary for Research, Education, and Economics will be accountable for coordinating research misconduct policies and procedures.
ACTIONS NEEDED TO ADDRESS THE CHALLENGE: Top Departmental leadership is critical to effecting the cultural changes necessary to the success of a unified approach to USDA program administration. The Department must foster improved interagency communication and data sharing in order to increase efficiency and to preclude the agencies from inadvertently working at odds with one another.
5
http://www.usda.gov/oig/webdocs/MgmtChallFinal050902.pdf
GAO-06-157R FDA Feed Testing Program
October 11, 2005
The Honorable Saxby Chambliss
Chairman
The Honorable Tom Harkin
Ranking Democratic Member
Committee on Agriculture, Nutrition, and Forestry
United States Senate
The Honorable Thad Cochran
United States Senate
The Honorable Richard J. Durbin
United States Senate
Subject: Mad Cow Disease: An Evaluation of a Small Feed Testing Program FDA
Implemented in 2003 With Recommendations for Making the Program a Better
Oversight Tool
In 1997, the Food and Drug Administration (FDA) banned the use of most proteins
derived from mammals (referred to as prohibited material) in feed intended for cattle
and other ruminants.1 The feed-ban rule is one of the primary actions taken by the
federal government to protect U.S. cattle from bovine spongiform encephalopathy
(BSE),2 commonly known as mad cow disease, which is believed to be spread through
feed that contains malformed protein found in certain tissue—particularly brain and
central nervous system tissue—of BSE-infected animals.3 Earlier this year, mad cow
disease was found for the first time in a 12-year old animal born and raised in the United
States.
In January 2002, we reported on the effectiveness of federal actions to prevent the
introduction and spread of BSE in the United States and identified a number of areas
where improvements were needed to strengthen FDA's oversight of firms in the feed
1Ruminants are animals with four-chambered stomachs, including, but not limited to, cattle, buffalo, sheep,
goats, deer, elk, and antelope. For the purpose of this report, "cattle" refers to cattle and all other
ruminant animals and "cattle feed" refers to feed for cattle and other ruminant animals.
2
21 C.F.R. §589.2000.
3
Adding protein (derived from animals or plants) to feed is a common nutritional practice used to speed
animal growth.
United States Government Accountability Office
Washington, DC 20548
2 GAO-06-157R FDA Feed Testing Program
industry.4 In February 2005, we issued a follow-up report that examined the
effectiveness of FDA's actions since the 2002 report to ensure industry compliance with
the feed-ban rule and protect U.S. cattle from BSE.5 Our report concluded that while
FDA has taken a number of positive steps, its processes still have room for improvement.
Our February 2005 report also noted that FDA had begun a small, discrete feed testing
program in August 2003. We reported that we would provide information on this new
feed testing program, which FDA described as a unique effort, once FDA provided us
with data on the feed tests. FDA later gave us the information we required to examine
those feed testing activities. Accordingly, this report assesses FDA's small feed testing
program and examines the extent to which this feed testing program helps FDA better
assure industry compliance with the feed-ban rule. This report is the final component of
our follow-up work on FDA's BSE prevention efforts.
FDA established the feed testing program in an assignment memorandum issued in
August 2003, entitled Assignment Memorandum—Sample Assignment for Domestic
Products, which contained instructions for implementing the program. The purpose of
the feed testing program was to collect and analyze cattle and other types of animal feed
and feed ingredients to determine whether feed that could be fed to cattle might contain
material prohibited by FDA's feed-ban rule. Under the program, FDA collected 641 feed
samples through the end of fiscal year 2004 and planned to collect 900 feed samples
during fiscal year 2005.
The 2003 guidance gave FDA's district offices responsibility for collecting samples and
submitting them to an FDA laboratory where analysts test the samples using a procedure
called feed microscopy—a visual (microscopic) examination for potentially prohibited
material, such as particles of bone, hair, or muscle fiber from certain animals. If an
analyst detects what appears to be prohibited material, the findings are confirmed by a
second analyst. According to FDA officials, some samples were tested using a more
specialized method called polymerase chain reaction (PCR), a test that FDA has been
piloting, which can differentiate ruminant DNA from other animal DNA.6
The guidance noted that because FDA had designated a number of cattle-derived
exemptions to the feed-ban rule, including blood, milk protein, and plate waste, the
laboratory tests could not definitively determine violations but, rather, could identify
potential violations. The guidance directs the districts to conduct follow-up reviews on
each potential violation to determine whether the facility represented by the sample
actually violates the feed ban. On the basis of the follow-up reviews, the districts assign
final compliance determinations—that the facility where the sample was collected has
complied with or has violated the feed-ban rule.
In June 2005, FDA issued a directive that all feed sample analysis and follow-up actions
4GAO, Mad Cow Disease: Improvements in the Animal Feed Ban and Other Regulatory Areas Would
Strengthen U.S. Prevention Efforts, GAO-02-183 (Washington, D.C.: Jan. 25, 2002).
5
GAO, Mad Cow Disease: FDA's Management of the Feed Ban Has Improved, but Oversight Weaknesses
Continue to Limit Program Effectiveness, GAO-05-101, (Washington, D.C.: Feb. 25, 2005).
6The PCR test works by aiding in the differentiation of mitochondrial DNA between animal species.
3 GAO-06-157R FDA Feed Testing Program
be recorded in FDA's central data system—the Field Accomplishments and Compliance
Tracking System (FACTS)—and that districts complete follow-up reviews of potential
violations within 30 working days. In July 2005, FDA issued a revised assignment
memorandum that, among other things, enhances the testing protocol by adopting the
PCR test for sample retesting and directs districts to provide sufficient narrative
explanation in FACTS to explain their final determination on samples that laboratories
identify as potential violations.
For the purpose of this report, we use the term "feed testing program" to distinguish the
samples FDA collected for the feed-testing assignments from samples FDA and states
collected in conjunction with routine BSE inspections. We included only the samples
that FDA collected for the assignments. To examine the extent to which FDA's feed
testing program provides better assurance of industry compliance with the feed-ban rule,
we reviewed FDA's data on 1,206 samples collected through June 2005. We identified
989 feed samples collected by FDA's district offices and analyzed by FDA laboratories
between August 2003 and June 2005, under the feed testing assignment/program
implemented under the August 2003 guidance document. We compared sample
collection, analysis, and follow-up with the program instructions in the August 2003
assignment memorandum. In order to assess FDA's timeliness in analyzing feed samples
and to determine results of these analyses, we analyzed data on feed sample collection
and laboratory analysis maintained in FACTS on the 989 feed samples. In order to assess
the types of follow-up activities carried out by the districts and the basis for their final
determinations on potential violations, we obtained and analyzed additional electronic
files from FDA districts and discussed those activities and determinations with officials
in the 19 FDA district offices. We also obtained detailed district-specific data and
information on sample collection, follow-up, and enforcement activities in interviews
with the officials in the 19 FDA district offices and discussed this information with FDA
headquarters officials. To assess the reliability of the FACTS data, we analyzed the feed
sample records in this database as of June 7, 2005. We analyzed the data to identify
problems with completeness, accuracy, or timeliness of data entry, and reviewed system
documentation on controls. We determined that the data were sufficiently reliable for
the purposes of this report. The testing program data assessed for this report, including
documentation in FACTS, spreadsheets maintained by individual district offices,
documents describing district follow-up actions for individual samples, and all written
guidance documents, were provided in response to our specific requests for all such
documentation and data related to the feed testing program. Finally, we examined the
feed testing program guidance that FDA provided in the June 2005 field management
directive and the July 2005 assignment memorandum and compared it with the
instructions and guidance FDA provided in the August 2003 memorandum. We
performed our work from February through August 2005 in accordance with generally
accepted government auditing standards. Our work included an assessment of FDA's
feed testing program data reliability and internal controls.
Results in Brief
The feed testing program is a small part of FDA's BSE oversight effort and is one of
several methods FDA uses to monitor for compliance with the feed-ban rule. However,
4 GAO-06-157R FDA Feed Testing Program
several weaknesses in the design and implementation of the feed testing program need to
be addressed to improve its effectiveness. Specifically, under the program guidance,
• FDA did not require districts to document their follow-up reviews or the basis for
their final determinations on samples that the laboratories identified as
potentially containing banned protein products. Although the districts may have
conducted rigorous follow-up and exercised sound judgment, the basis for their
decisions cannot be reviewed and confirmed.
• For nearly half the 989 samples, FDA took longer than 30 days from the date the
sample was collected until the date the laboratory completed its analysis—
including 21 samples that took longer than 100 days. This extended period does
not include the time FDA's districts would have spent following up on samples
that indicated potential violations. FDA and industry agree that cattle feed is
consumed very quickly. By the time FDA conducted its follow up to determine
whether a violation had occurred, the feed may have been consumed.
• FDA managers in headquarters did not adequately oversee the feed testing
program. Specifically, FDA managers did not receive periodic reports or have
other oversight controls in place to assure that the program was implemented
correctly. Moreover, FDA did not identify intended program goals and, as a
result, does not know whether or to what extent the feed testing program is
contributing to the agency's BSE oversight efforts.
FDA's June 2005 directive and July 2005 revised instructions—issued nearly 2 years into
the program—includes (1) a requirement that follow-up actions and compliance
determinations be fully documented in FDA's centralized FACTS compliance tracking
system with sufficient explanation to allow the reader to understand the basis for the
decision and (2) a time limit for districts to complete follow-up reviews.
To ensure that the feed testing program contributes to FDA's BSE oversight efforts, we
are recommending that FDA (1) fully implement the June 2005 field management
directive and July 2005 assignment memorandum, (2) assure that districts and
laboratories adhere to time limits on collecting samples, completing sample analysis, and
carrying out follow-up activities to minimize cattle's exposure to potentially
contaminated feed, and (3) require sufficient oversight by headquarters managers to
assure the program is achieving its intended goals.
In commenting on a draft of this report, FDA expressed concern that GAO was issuing a
report that focused on one small aspect of FDA's BSE oversight efforts. We agree that it
is a small component of FDA's overall efforts, but it vies for FDA's limited BSE oversight
resources. Furthermore, as we pointed out in our more comprehensive February 2005
report, we looked at this small program separately because FDA did not provide program
data in time for its inclusion in the broader report. FDA also disagreed with two of our
recommendations in a draft of this report: that it set a time period for laboratories to
complete sample analyses and that headquarters managers exercise sufficient oversight
to assure the program operates as intended. FDA indicated that it had some target
timeframes for laboratories. Because we could not pinpoint where delays were
occurring, we revised our recommendation to address the need to minimize overall
time—from sample collection through analysis and follow-up activities—in order to
minimize cattle's exposure to potentially dangerous feed. With regard to our
recommendation for better management oversight, FDA disagreed with our assertion
that the program was not sufficiently monitored and noted the activities its managers
have undertaken. We modified that recommendation to clarify what we believe is
needed in terms of management oversight.
SNIP...FULL TEXT 29 PAGES ;
http://www.gao.gov/new.items/d06157r.pdf
Audit Report
Animal and Plant Health Inspection Service
Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase II
and
Food Safety and Inspection Service
Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III
Report No. 50601-10-KC January 2006
Finding 2 Inherent Challenges in Identifying and Testing High-Risk Cattle Still Remain
Our prior report identified a number of inherent problems in identifying and testing high-risk cattle. We reported that the challenges in identifying the universe of high-risk cattle, as well as the need to design procedures to obtain an appropriate representation of samples, was critical to the success of the BSE surveillance program. The surveillance program was designed to target nonambulatory cattle, cattle showing signs of CNS disease (including cattle testing negative for rabies), cattle showing signs not inconsistent with BSE, and dead cattle. Although APHIS designed procedures to ensure FSIS condemned cattle were sampled and made a concerted effort for outreach to obtain targeted samples, industry practices not considered in the design of the surveillance program reduced assurance that targeted animals were tested for BSE.
In our prior report, we recommended that APHIS work with public health and State diagnostic laboratories to develop and test rabies-negative samples for BSE. This target group is important for determining the prevalence of BSE in the United States because rabies cases exhibit clinical signs not inconsistent with BSE; a negative rabies test means the cause of the clinical signs has not been diagnosed.
APHIS agreed with our recommendation and initiated an outreach program with the American Association of Veterinary Laboratory Diagnosticians, as well as State laboratories. APHIS also agreed to do ongoing monitoring to ensure samples were obtained from this target population.
Although APHIS increased the samples tested from this target group as compared to prior years, we found that conflicting APHIS instructions on the ages of cattle to test resulted in inconsistencies in what samples were submitted for BSE testing. Therefore, some laboratories did not refer their rabies negative samples to APHIS in order to maximize the number tested for this critical target population. In addition, APHIS did not monitor the number of submissions of rabies negative samples for BSE testing from specific laboratories.
According to the Procedure Manual for BSE Surveillance, dated October 2004, the target population includes:
Central nervous system (CNS) signs and/or rabies negative - sample animals of any age (emphasis added):
a. Diagnostic laboratories –samples submitted due to evidence of CNS clinical signs.
snip......
APHIS notes that for the current surveillance program, it had established regional goals and APHIS was not trying to meet particular sampling levels in particular States. However, we believe that it would be advantageous for APHIS to monitor collection data and increase outreach when large geographical areas such as the above States do not provide samples in proportion to the numbers and types of cattle in the population.
We also disagree with APHIS/FSIS' contention that because they have tested over 375,000 of their 446,000 estimate of high risk cattle, few in the high-risk population are being missed, including those that might be pre-screened before entering a slaughter facility's property. In our prior audit, we reported that APHIS underestimated the high-risk population; we found that this estimate should have been closer to 1 million animals (see Finding 1). We recognize that BSE samples are provided on a voluntary basis; however, APHIS should consider industry practice in any further maintenance surveillance effort. Animals unsuitable for slaughter exhibiting symptoms not inconsistent with BSE should be sampled and their clinical signs recorded. However, this cited industry practice results in rejected animals not being made available to either APHIS or FSIS veterinarians for their observation and identification of clinical signs exhibited ante mortem. Although these animals may be sampled later at other collection sites, the animals are provided post mortem without information as to relevant clinical signs exhibited ante mortem. For these reasons, we believe APHIS needs to
USDA/OIG-A/50601-10-KC Page 27
observe these animals ante mortem when possible to assure the animals from the target population are ultimately sampled and the clinical signs evaluated.
snip...
http://www.usda.gov/oig/webdocs/50601-10-KC.pdf
IN COMMERCE 2006
Subject: MAD COW FDA FEED WARNING LETTER NO. 2007-NOL-01 October 26, 2006 H.J. Baker & Bro., Inc.
Date: November 7, 2006 at 9:08 am PST
Food and Drug Administration
New Orleans District
404 BNA Drive, Building 200, Suite 500
Nashville, TN 37217
Telephone: 615-366-7801
Facsimile: 615-366-7802
October 26, 2006
WARNING LETTER NO. 2007-NOL-01
FEDERAL EXPRESS
OVERNIGHT DELIVERY
Mr. Christopher V. B. Smith
Corporate President, CEO
H. J. Baker & Bro., Inc.
228 Saugatuck Avenue
Westport, Connecticut 06880
Dear Mr. Smith:
On June 6, 8, 12-15, and 23, 2006, a U.S . Food and Drug Administration (FDA) investigator inspected
your animal feed protein supplement manufacturing facility, located at 603 Railroad Avenue,
Albertville, Alabama. The inspection revealed significant deviations from the requirements set forth in
Title 21, Code ofFederal Regulations, Part 589.2000 (21 CFR 589.2000), Animal Proteins Prohibited in
Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE). You failed to follow the requirements of this regulation, resulting
in products being manufactured and distributed by your facility because they are adulterated within the
meaning of Section 402(a)(4) [21 USC 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the
Act) and misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)(1)] of the Act.
Our investigation determined adulteration resulted from the failure of your firm to establish and
implement measures sufficient to prevent commingling or cross-contamination . The adulterated feed
was subsequently misbranded because it was not properly labeled. Specifically, we found :
" Your firm failed to establish and use cleanout procedures or other means to prevent carry-over of
products which contain or may contain protein derived from mammalian tissues into animal protein
or feeds which may be used for ruminants, as required by 21 CFR 589.2000(e)(1)(iii)(B) .
Specifically, you failed to establish and use such measures for a screw auger installed in February
2005 . This auger is used to convey both prohibited and non-prohibited material to bulk storage bins.
In addition, you failed to follow the cleanout procedure your firm had developed for the receiving
systems. Your feed is, therefore, adulterated under Section 402(a)(4) [21 USC 342(a)(4)] of the Act.
" You failed to label all products which contained or may have contained prohibited materials with the
BSE cautionary statement, "Do not feed to cattle or other ruminants," as required by 21 CFR
589.2000(e)(1)(i) . Such products are misbranded under Section 403(3) [21 USC 343(a)(1)] of the
Act. These misbranded products include the three Pro-Pak products mentioned below, as well as
Page 2 - H. J . Baker & Bro., Inc., Albertville, Alabama Warning Letter No. 2007-NOL-O 1
those bulk loads of individual feed ingredients processed through this common screw auger and
distributed between the time it was installed in February 2005, and June 9, 2006 .
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.
We acknowledge your June 16, 2006, voluntary recall of three products you manufactured from
February 2005 to June 2006. The three products recalled were: Pro-Lak Protein Concentrate for
Lactating Dairy Animals; Pro-Amino II for PreFresh and Lactating Cows; and, Pro-Pak Marine & Animal Protein Concentrate for Use in Animal Feed. Recall effectiveness checks and other measures
will determine the merit of this recall . We recognize you now label all products with the required BSE
cautionary statement and we also acknowledge your intent, given verbally to New Orleans District
management of the FDA, to discontinue the production of supplements which do not contain prohibited
materials. In your written response to this letter, please confirm in writing you have taken these steps.
You should notify this office in writing within 15 working days of receiving this letter, outlining the specific steps you have taken to bring your firm into compliance with the law, including the steps we acknowledge above and any additional steps you have taken. Your response should include an
explanation of each step taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating corrections have been made.
Your reply should be directed to Kari L. Batey, Compliance Officer, at the address above. If you have
questions regarding any issue in this letter, please contact Ms. Batey at (615) 366-7808.
Sincerely,
,
Carol S . Sanchez
Acting District Director
New Orleans District
Enclosure: Form FDA 483
cc: Craig R. Waterhouse
Plant Manager
H.J. Baker & Bros., Inc.
603 Railroad Avenue
Albertville, Alabama 35951-3419
http://www.fda.gov/foi/warning_letters/g6104d.pdf
MORE 2006 FEED BAN VIOLATIONS BELOW, ''IN COMMERCE'' ;
Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL,
TN, AND WV
Date: September 6, 2006 at 7:58 am PST
PRODUCT
a) EVSRC Custom dairy feed, Recall # V-130-6;
b) Performance Chick Starter, Recall # V-131-6;
c) Performance Quail Grower, Recall # V-132-6;
d) Performance Pheasant Finisher, Recall # V-133-6.
CODE
None
RECALLING FIRM/MANUFACTURER
Donaldson & Hasenbein/dba J&R Feed Service, Inc., Cullman, AL, by telephone
on June 23, 2006 and by letter dated July 19, 2006. Firm initiated recall is
complete.
REASON
Dairy and poultry feeds were possibly contaminated with ruminant based
protein.
VOLUME OF PRODUCT IN COMMERCE
477.72 tons
DISTRIBUTION
AL
______________________________
PRODUCT
a) Dairy feed, custom, Recall # V-134-6;
b) Custom Dairy Feed with Monensin, Recall # V-135-6.
CODE
None. Bulk product
RECALLING FIRM/MANUFACTURER
Recalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning on
June 28, 2006.
Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiated
recall is complete.
REASON
Possible contamination of dairy feeds with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
1,484 tons
DISTRIBUTION
TN and WV
http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html
Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA,
MS, AL, GA, AND TN 11,000+ TONS
Date: August 16, 2006 at 9:19 am PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-115-6
CODE
None
RECALLING FIRM/MANUFACTURER
Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or
about July 14, 2006. FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,223 tons
DISTRIBUTION
KY
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-116-6
CODE
None
RECALLING FIRM/MANUFACTURER
Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006.
FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
1,220 tons
DISTRIBUTION
KY
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-117-6
CODE
None
RECALLING FIRM/MANUFACTURER
Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated
recall is completed.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
40 tons
DISTRIBUTION
LA and MS
______________________________
PRODUCT
Bulk Dairy Feed, Recall V-118-6
CODE
None
RECALLING FIRM/MANUFACTURER
Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA
initiated recall is complete.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
7,150 tons
DISTRIBUTION
MS
______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-119-6
CODE
None
RECALLING FIRM/MANUFACTURER
Walthall County Co-op, Tylertown, MS, by telephone on June 26, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
87 tons
DISTRIBUTION
MS
______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-120-6
CODE
None
RECALLING FIRM/MANUFACTURER
Ware Milling Inc., Houston, MS, by telephone on June 23, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
350 tons
DISTRIBUTION
AL and MS
______________________________
PRODUCT
a) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet,
50 lb. bags, Recall # V-121-6;
b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet,
50 lb. bags, Recall # V-122-6;
c) Tucker Milling, LLC #31232 Game Bird Grower,
50 lb. bags, Recall # V-123-6;
d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD
Medicated, 50 lb bags, Recall # V-124-6;
e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags,
Recall # V-125-6;
f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags,
Recall # V-126-6;
g) Tucker Milling, LLC #30116, TM Broiler Finisher,
50 lb bags, Recall # V-127-6
CODE
All products manufactured from 02/01/2005 until 06/20/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visit
on June 20, 2006, and by letter on June 23, 2006.
Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated
recall is ongoing.
REASON
Poultry and fish feeds which were possibly contaminated with ruminant based
protein were not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
7,541-50 lb bags
DISTRIBUTION
AL, GA, MS, and TN
END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006
###
http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.html
Subject: MAD COW FEED RECALL MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN
COMMERCE 27,694,240 lbs
Date: August 6, 2006 at 6:14 pm PST
PRODUCT
Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6
CODE
All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J.
Baker recalled feed products.
RECALLING FIRM/MANUFACTURER
Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm
initiated recall is complete.
REASON
The feed was manufactured from materials that may have been contaminated
with mammalian protein.
VOLUME OF PRODUCT IN COMMERCE
27,694,240 lbs
DISTRIBUTION
MI
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
Subject: MAD COW FEED RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125
TONS Products manufactured from 02/01/2005 until 06/06/2006
Date: August 6, 2006 at 6:16 pm PST
PRODUCT
a) CO-OP 32% Sinking Catfish, Recall # V-100-6;
b) Performance Sheep Pell W/Decox/A/N, medicated,
net wt. 50 lbs, Recall # V-101-6;
c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6;
d) CO-OP 32% Sinking Catfish Food Medicated,
Recall # V-103-6;
e) "Big Jim's" BBB Deer Ration, Big Buck Blend,
Recall # V-104-6;
f) CO-OP 40% Hog Supplement Medicated Pelleted,
Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6;
g) Pig Starter Pell II, 18% W/MCDX Medicated 282020,
Carbadox -- 0.0055%, Recall # V-106-6;
h) CO-OP STARTER-GROWER CRUMBLES, Complete
Feed for Chickens from Hatch to 20 Weeks, Medicated,
Bacitracin Methylene Disalicylate, 25 and 50 Lbs,
Recall # V-107-6;
i) CO-OP LAYING PELLETS, Complete Feed for Laying
Chickens, Recall # 108-6;
j) CO-OP LAYING CRUMBLES, Recall # V-109-6;
k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED,
net wt 50 Lbs, Recall # V-110-6;
l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs,
Recall # V-111-6;
m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs,
Recall # V-112-6
CODE
Product manufactured from 02/01/2005 until 06/06/2006
RECALLING FIRM/MANUFACTURER
Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and
visit on June 9, 2006. FDA initiated recall is complete.
REASON
Animal and fish feeds which were possibly contaminated with ruminant based
protein not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
125 tons
DISTRIBUTION
AL and FL
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
Subject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ?????
Date: August 6, 2006 at 6:19 pm PST
PRODUCT
Bulk custom made dairy feed, Recall # V-114-6
CODE
None
RECALLING FIRM/MANUFACTURER
Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated
recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak, which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
?????
DISTRIBUTION
KY
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
CJD WATCH MESSAGE BOARD
TSS
MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE
Sun Jul 16, 2006 09:22
71.248.128.67
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,
Recall # V-079-6;
b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),
Recall # V-080-6;
c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL
FEED, Recall # V-081-6;
d) Feather Meal, Recall # V-082-6
CODE
a) Bulk
b) None
c) Bulk
d) Bulk
RECALLING FIRM/MANUFACTURER
H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and
by press release on June 16, 2006. Firm initiated recall is ongoing.
REASON
Possible contamination of animal feeds with ruminent derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
10,878.06 tons
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR July 12, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html
Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006
Date: June 27, 2006 at 7:42 am PST
Public Health Service
Food and Drug Administration
New Orleans District
297 Plus Park Blvd.
Nashville, TN 37217
Telephone: 615-781-5380
Fax: 615-781-5391
May 17, 2006
WARNING LETTER NO. 2006-NOL-06
FEDERAL EXPRESS
OVERNIGHT DELIVERY
Mr. William Shirley, Jr., Owner
Louisiana.DBA Riegel By-Products
2621 State Street
Dallas, Texas 75204
Dear Mr. Shirley:
On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration
(FDA) investigator inspected your rendering plant, located at 509 Fortson
Street, Shreveport, Louisiana. The inspection revealed significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in
Ruminant Feed. This regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). You failed to
follow the requirements of this regulation; products being manufactured and
distributed by your facility are misbranded within the meaning of Section
403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act
(the Act).
Our investigation found you failed to provide measures, including sufficient
written procedures, to prevent commingling or cross-contamination and to
maintain sufficient written procedures [21 CFR 589.2000(e)] because:
You failed to use clean-out procedures or other means adequate to prevent
carryover of protein derived from mammalian tissues into animal protein or
feeds which may be used for ruminants. For example, your facility uses the
same equipment to process mammalian and poultry tissues. However, you use
only hot water to clean the cookers between processing tissues from each
species. You do not clean the auger, hammer mill, grinder, and spouts after
processing mammalian tissues.
You failed to maintain written procedures specifying the clean-out
procedures or other means to prevent carryover of protein derived from
mammalian tissues into feeds which may be used for ruminants.
As a result . the poultry meal you manufacture may contain protein derived
from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR
589.2000(e)(1)(i), any products containing or may contain protein derived
from mammalian tissues must be labeled, "Do not feed to cattle or other
ruminants." Since you failed to label a product which may contain protein
derived from mammalian tissues with the required cautionary statement. the
poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the
Act.
This letter is not intended 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 within 15 working days of receiving
this letter, outlining the specific steps you have taken to bring your firm
into compliance with the law. Your response should include an explanation of
each step taken to correct the violations and prevent their recurrence. If
corrective action cannot be completed within 15 working days, state the
reason for the delay and the date by which the corrections will be
completed. Include copies of any available documentation demonstrating
corrections have been made.
Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S.
Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie,
Louisiana 70001. If you have questions regarding any issue in this letter,
please contact Mr. Rivero at (504) 219-8818, extension 103.
Sincerely,
/S
Carol S. Sanchez
Acting District Director
New Orleans District
http://www.fda.gov/foi/warning_letters/g5883d.htm
Subject: MAD COW FEED RECALL 220,740 LBS Biofix Holding Inc, Denton, TX
Date: December 22, 2006 at 8:51 am PST
PRODUCT
Harina De Carne Y Hueso Porcina 58% Proteina (Pork Meat and Bone Meal 58% Protein), 50 kg bags, Recall # V-005-2007
CODE
No lot number. Shipment Purchase Order number: BH-06-1085.
RECALLING FIRM/MANUFACTURER:
Recalling Firm: Biofix Holding Inc, Denton, TX, by letter on October 16, 2006.
Manufacturer: Allied Premium Protein, Gaffney, SC. Firm initiated recall is ongoing.
REASON
Pork Meal with potential to be contaminated with prohibited material distributed without cautionary statement.
VOLUME OF PRODUCT IN COMMERCE
220,740 lbs
DISTRIBUTION
Honduras
END OF ENFORCEMENT REPORT FOR December 20, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00983.html
NOW, look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused
7% (1 of 14) of the cows to come down with BSE;
Risk of oral infection with bovine spongiform encephalopathy agent in
primates
Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog,
Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie
Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe
Deslys
Summary The uncertain extent of human exposure to bovine spongiform
encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease
(vCJD)--is compounded by incomplete knowledge about the efficiency of oral
infection and the magnitude of any bovine-to-human biological barrier to
transmission. We therefore investigated oral transmission of BSE to
non-human primates. We gave two macaques a 5 g oral dose of brain homogenate
from a BSE-infected cow. One macaque developed vCJD-like neurological
disease 60 months after exposure, whereas the other remained free of disease
at 76 months. On the basis of these findings and data from other studies, we
made a preliminary estimate of the food exposure risk for man, which
provides additional assurance that existing public health measures can
prevent transmission of BSE to man.
snip...
BSE bovine brain inoculum
100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg
Primate (oral route)* 1/2 (50%)
Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%)
1/15 (7%)
RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)
PrPres biochemical detection
The comparison is made on the basis of calibration of the bovine inoculum
used in our study with primates against a bovine brain inoculum with a
similar PrPres concentration that was
inoculated into mice and cattle.8 *Data are number of animals
positive/number of animals surviving at the time of clinical onset of
disease in the first positive animal (%). The accuracy of
bioassays is generally judged to be about plus or minus 1 log. ic
ip=intracerebral and intraperitoneal.
Table 1: Comparison of transmission rates in primates and cattle infected
orally with similar BSE brain inocula
Published online January 27, 2005
http://www.thelancet.com/journal/journal.isa
It is clear that the designing scientists must
also have shared Mr Bradley's surprise at the results because all the dose
levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s145d.pdf
Working Group Report on
the Assessment of the Geographical BSE-Risk (GBR) of
CANADA
2004
snip...
- 2 -
2. EXTERNAL CHALLENGES
2.1 Import of cattle from BSE-Risk2 countries
An overview of the data on live cattle imports is presented in table 1 and is based on
data as provided in the country dossier (CD) and corresponding data on relevant exports
as available from BSE risk countries that exported to Canada. Only data from risk
periods are indicated, i.e. those periods when exports from a BSE risk country already
represented an external challenge, according to the SSC opinion on the GBR (SSC July
2000 and updated January 2002).
• According to the CD, 231 cattle were imported from UK during the years 1980 to
1990 and no cattle imports from UK were recorded after 1990.
• According to Eurostat, altogether 198 cattle have been imported from the UK during
the years 1980 to 1990, Additionally 500 were recorded in 1993; this import is
1 For the purpose of the GBR assessment the abbreviation "MBM" refers to rendering products, in particular
the commodities Meat and Bone Meal as such; Meat Meal; Bone Meal; and Greaves. With regard to imports
it refers to the customs code 230110 "flours, meals and pellets, made from meat or offal, not fit for human
2 BSE-Risk countries are all countries already assessed as GBR III or IV or with at least one confirmed
Annex to the EFSA Scientific Report (2004) 2, 1-14 on the Assessment of the
Geographical BSE Risk of Canada
- 3 -
mentioned in Eurostat and the updated UK export statistic as male calves, but not
mentioned in the original UK export statistics. According to the CD, detailed
investigations were carried out and it is very unlikely that the 500 calves have been
imported. Therefore, they were not taken into account.
• According to the CD, in 1990 all cattle imported from UK and Ireland since 1982
were placed in a monitoring program.
• Following the occurrence of the BSE index case in 1993 (imported from UK in 1987
at the age of 6 months), an attempt was made to trace all other cattle imported from
UK between 1982 and 1990.
• Of the 231 cattle imported from the UK between 1980 and 1990, 108 animals had
been slaughtered and 9 had died. From the remaining, 37 were exported, 76 were
sent to incineration and one was buried; these were not entering the rendering system
and therefore not taken into account.
• According to the CD, 16 cattle were imported from Ireland (according to Eurostat
20), of which 9 were slaughtered, 3 died. The remaining 4 were incinerated and did
therefore not enter the rendering system. According to the CD, the 6 animals which
were imported in 1990 according to Eurostat, were never imported.
• Moreover 22 cattle have been imported from Japan (through USA), of which 4 were
exported (excluded from the table) and 14 were destroyed and therefore not entering
the rendering system, 4 were slaughtered.
• Of 28 imported bovines from Denmark, 1 was destroyed and 1 was exported. Of the
19 buffalos imported in 2000, 1 was incinerated and the others were ordered to be
destroyed.
• Additionally in total 264 cattle according to the CD (276 according to other sources)
were imported from Austria, France, Germany, Hungary, Italy, The Netherlands and
Switzerland.
• The numbers imported according to the CD and Eurostat are very similar. Some
discrepancies in the year of import can be explained by an extended quarantine;
therefore it is likely that imports according to Eurostat in 1980 and imports
according to the CD in 1981 are referring to the same animals.
• Additionally, between 16.000 and 340.000 bovines have annually been imported
from US, almost all are steers and heifers. In total, between 1981 and 2003,
according to the CD more than 2.3 million, according to other sources 1.5 million
cattle have been imported.
• According to the CD, feeder/slaughter cattle represent typically more than 90% of
the imported cattle from the USA; therefore, only 10% of the imported cattle have
been taken into account.
snip...
Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the
Geographical BSE Risk of Canada
2.2 Import of MBM or MBM-containing feedstuffs from BSE-Risk
countries
An overview of the data on MBM imports is presented in table 2 and is based on data
provided in the country dossier (CD) and corresponding data on relevant exports as
available from BSE risk countries that exported to Canada. Only data from risk periods
are indicated, i.e. those periods when exports from a BSE risk country already
represented an external challenge, according to the SSC opinion on the GBR (SSC, July
2000 and updated January 2002).
According to the CD, no imports of MBM took place from UK since 1978 (initially
because of FMD regulations).
• According to Eurostat data, Canada imported 149 tons MBM from the UK in the
period of 1993 to 2001. According to up-dated MBM statistics from UK (August
2001) no mammalian MBM was exported to Canada from 1993 – 1996. As it was
illegal to export mammalian meat meal, bone meal and MBM from UK since
27/03/1996, exports indicated after that date should only have included nonmammalian
MBM. Therefore, these imports were not taken into account.
• According to the CD, imports of MBM have taken place from Denmark, Germany,
France, Japan and US.
• According to Eurostat Canada imported MBM from Denmark, Belgium, France and
Ireland.
• According to the CD further investigations concluded that all imported MBM from
Denmark consisted of pork and poultry origin and was directly imported for
aquaculture, the imported MBM from France was feather meal, the imported MBM
from Germany was poultry meal for aquaculture and the imported MBM from
Belgium was haemoglobin; therefore these imports were not taken into account.
• The main imports of MBM were of US origin, according to the CD around 250.000
tons, according to other sources around 310.000 tons between 1988 and 2003.
snip...
2.3 Overall assessment of the external challenge
The level of the external challenge that has to be met by the BSE/cattle system is
estimated according to the guidance given by the SSC in its final opinion on the GBR of
July 2000 (as updated in January 2002).
Live cattle imports:
In total the country imported according to the CD more than 2.3 million, according to
other data 1.5 million live cattle from BSE risk countries, of which 231 (CD)
respectively 698 (other sources) came from the UK. The numbers shown in table 1 are
the raw import figures and are not reflecting the adjusted imports for the assessment of
the external challenge. Broken down to 5 year periods the resulting external challenge is
as given in table 3. This assessment takes into account the different aspects discussed
above that allow to assume that certain imported cattle did not enter the domestic
BSE/cattle system, i.e. were not rendered into feed. In the case of Canada, the 500 cattle
imported from UK according to Eurostat were not taken into account and it is assumed
that all incinerated, buried, exported animals and the animals still alive did not enter the
rendering system and were therefore excluded from the external challenge.
MBM imports:
In total the country imported according to the CD around 300.000 tons, according to
other sources nearly 360.000 tons of MBM from BSE risk countries, of which 149 tons
came from the UK. The majority consisted of MBM imported from the US. The
numbers shown in table 2 are the raw import figures and are not reflecting the adjusted
imports for the assessment of the external challenge. Broken down to 5 year periods the
resulting external challenge is as given in table 3. This assessment takes into account
the different aspects discussed above that allow to assume that certain imported MBM
did not enter the domestic BSE/cattle system or did not represent an external challenge
for other reasons. As it was illegal to export mammalian meat meal, bone meal and
MBM from UK since 27/03/1996, exports indicated after that date should only have
included non-mammalian MBM. In the case of Canada all imported MBM from UK,
Germany, Belgium, Denmark and France was not taken into account.
snip...
3. STABILITY
3.1 Overall appreciation of the ability to avoid recycling of BSE
infectivity, should it enter processing
Feeding
The annual Canadian production of MBM is approximately 575,000 tons of which
approx. 40,000 tons are exported each year, mainly to USA.
Use of MBM in cattle feed
• Before the feed ban, dairy cattle received supplementary feed containing MBM
during their productive life (maximum 200-400 g MBM per day). Beef cattle in the
western part of the country do not usually receive complementary feed. Beef cattle
in the eastern part receive normally no supplement protein but the calves could have
access to creep feeds containing MBM, after weaning the ratios may have contained
supplemental protein containing MBM (100-400 g per day).
• According to the CD, MBM is mainly fed to pigs and poultry and included in pet
food.
• According to the CD, only a proportion of dairy cattle may have received MBM.
Feed bans
• Before 1997, there was no legal restriction to include MBM into cattle feed.
• An MBM-ban was introduced in August 1997; it is forbidden since to feed
mammalian MBM to ruminants except if of pure porcine, equine and non
mammalian origin, i.e. in practice a ruminant-to-ruminant ban (RMBM-ban).
Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the
Geographical BSE Risk of Canada
- 9 -
Potential for cross-contamination and measures taken against
• Cross-contamination in the about 600 feed mills is assumed to be possible as long as
cattle and pig feed is produced in the same production lines, and premises.
• Cross-contamination during transport is possible, particularly if the same trucks are
used for transporting ruminant MBM (RMBM) and non-ruminant MBM (porcine or
poultry MBM which still might be included into cattle feed) or for transporting
pig/poultry feed and cattle feed.
• On-farm cross-contamination is regarded to be possible.
• Cross-contamination of cattle feed with RMBM can not be excluded. Hence, as
reasonable worst case scenario, it has to be assumed that cattle, in particular dairy
cattle, can still be exposed to RMBM and hence to BSE-infectivity, should it enter
the feed chain.
Control of Feed bans and cross-contamination
• With the introduction of the RMBM ban (1997) the feed mills (approximately 600)
were checked for compliance with the ban, including good manufacturing practices
(GMP) and record keeping, i.e. the separation in production of MBM containing
ruminant material (RMBM) from non-ruminant MBM.
• The feed mills had previously – since 1983 – been regularly checked in relation to
production of medicated feed.
• No examinations are performed to assess cross-contamination with RMBM of the
protein (e.g. non ruminant MBM) that enters cattle feed. Differentiation would
anyway be difficult.
Rendering
Raw material used for rendering
• Ruminant material is rendered together with material from other species, but
according to the CD only in the production of MBM prohibited for use in ruminant
feeds.
• Slaughter by-products, including specified risk material (SRM) and fallen stock are
rendered.
• The country expert estimated that 20% of the rendering plants, processing 20% of
the total amount of raw material, are connected to slaughterhouses. Their raw
material is more than 98 % animal waste from these slaughterhouses while less than
2 % is fallen stock. No estimation was given for the remaining 80% of the rendering
capacity.
• There are 32 rendering plants of which 3 are processing blood exclusively.
Rendering processes
• The rendering systems (parameters) were specified for 6 plants producing mixed
MBM, none of these fulfilled the 133/20/3 standard. Of these, 5 have dedicated
facilities to produce products for use in ruminant feed and products not permitted for
use in ruminant feed.
• The remaining plants process porcine or poultry material exclusively.
SRM and fallen stock
• There is an SRM ban for human food in place since 2003.
Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the
Geographical BSE Risk of Canada
- 10 -
• However, SRM are rendered together with other slaughter waste and fallen stock.
However, according to the CD, MBM with SRM is not permitted to be fed to
ruminants.
Conclusion on the ability to avoid recycling
• Between 1980 and 1997 the Canadian system would not have been able to avoid
recycling of the BSE-agent to any measurable extent. If the BSE-agent was
introduced into the feed chain, it could have reached cattle.
• Since 1997 this ability gradually improved with the introduction of the ruminant
MBM ban and its implementation.
• Since cross-contamination cannot be excluded, and as SRM is still rendered by
processes unable to significantly reduce BSE-infectivity, the system is still unable to
avoid recycling of BSE-infectivity already present in the system or incoming.
3.2 Overall appreciation of the ability to identify BSE-cases and to
eliminate animals at risk of being infected before they are processed
Cattle population structure
• Cattle population: 12.15 Million in 1988 increasing to 14.6 Million in 2001;
• Of the total cattle population, 2.2 million are dairy cattle and 12.4 million are beef.
• The cattle population above 24 months of age: approx. 6.0 Million.
• Of the approximately 2.2 Million dairy cattle 2 Million are located in the two eastern
provinces Ontario and Quebec.
• Mixed farming (cattle and mono-gastric species) is usually not practiced; the
country expert estimated the proportion of mixed farming to be less than 1%.
• Individual regions traditionally have ID systems under provincial authorities. Brand
inspectors are present when cattle are assembled. It is estimated by the Canadians
that the level of a national, uniform ID for cattle is less than 10%; most of those
individual pedigree animals. Mandatory ID for the milk-fed veal sector was
implemented in Quebec in 1996, but does not contain information on the herd of
origin. An agreement of the relevant industries to develop a national cattle ID and
trace back strategy was reached on 1 May 1998 (starting in 2001).Since 2002, a
national identification program is existing. Al cattle leaving any farm premises must
be uniquely identified by ear tag.
BSE surveillance
• BSE was made notifiable in 1990.
• Every cow over one year of age exhibiting central nervous system signs suggestive
of BSE submitted to a laboratory or presented at an abattoir is subjected to a BSE
laboratory diagnostic test (histology and over the past years also PrPSc-based
laboratory tests).
• In addition, cattle submitted for rabies examination and found rabies negative are
examined for BSE. Samples are prepared immediately upon arrival to the federal
laboratory responsible for the rabies diagnostic for possible later BSE examination,
i.e. formalin fixation.
• Since the 1940's, a rabies control program has been in place, where farmers,
veterinarians and the general public are well educated about this neurological
Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the
Geographical BSE Risk of Canada
- 11 -
disease. In 1990, when BSE was made notifiable, this awareness was extended to
suspicions of BSE.
• Since 1993 the number of brains examined per year did exceed the number
recommended by OIE (300 - 336 for countries with a cattle population over 24
months of age of 5.0 to 7.0 Million) in all years, except in 1995 (table 4).
year 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003
samples 225 645 426 269 454 759 940 895
:shock: