SEARCH VEGSOURCE:

 

 

Follow Ups | Post Followup | Back to Discussion Board | VegSource
See spam or
inappropriate posts?
Please let us know.
  




From: TSS ()
Subject: Re: Docket: 2003N-0312 - Animal Feed Safety System; ... Request for Comments PART II
Date: August 9, 2006 at 1:36 pm PST

In Reply to: Docket: 2003N-0312 - Animal Feed Safety System; ... Request for Comments posted by TSS on August 3, 2006 at 1:06 pm:


----- Original Message -----
From: Terry S. Singeltary Sr.
To: fdadockets@oc.fda.gov
Cc: Phyllis.Fong@usda.gov
Sent: Wednesday, August 09, 2006 3:54 PM
Subject: Re: Docket: 2003N-0312 - Animal Feed Safety System: A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds; Request for Comments


Docket: 2003N-0312 - Animal Feed Safety System: A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds; Request for Comments PART II

BSE Ruminant and Mammalian mad cow protein in commerce USA 2000 - 2006 compliments FDA/USDA/TSS et al 'THE BIGGER PICTURE'


30936 Federal Register / Vol. 62, No. 108 / Thursday, June 5, 1997 / Rules and Regulations

21 CFR Part 589

Substances Prohibited From Use in

Animal Food or Feed; Animal Proteins

Prohibited in Ruminant Feed; Final Rule

http://www.fda.gov/cvm/Images/6597bse.pdf


BSE/Ruminant Feed Ban Inspections

FOOD AND DRUG ADMINISTRATION

COMPLIANCE PROGRAM GUIDANCE MANUAL

http://www.fda.gov/ohrms/dockets/98fr/03d-0498-gdl0001.pdf


1999 - 2000 CVM BSE

CVM Update
(THIS IS NOT A JOKE...TSS)
May 13, 1999

BSE FEED REGULATION TEAM TO RECEIVE VICE PRESIDENTIAL AWARD

On May 14, the Food and Drug Administration (FDA)/Association of American Feed Control Officials (AAFCO) Bovine Spongiform Encephalopathy Feed Regulation Team will be honored with Vice President Al Gore's Hammer Award. The BSE Feed Regulation Team is comprised of employees from FDA's Center for Veterinary Medicine (CVM) and Office of Regulatory Affairs (ORA), and AAFCO, an organization that includes officials from all States and the Federal government who are responsible for enforcing the laws regulating the production, labeling, distribution, and/or sale of animal feeds.

The Award will be presented by Yetta Lyle who will be representing the Vice President's National Partnership for Reinventing Government at CVM's 1999 Honor Awards Ceremony. The Awards ceremony will be held from 9:30 - 11:30 a.m., at the Gaithersburg Hilton Hotel, Grand Ballroom, 620 Perry Parkway, in Gaithersburg, MD. The 17 team members who spearheaded the effort will be honored.

The award citation reads, "For making a significant contribution to reducing the possibility of bovine spongiform encephalopathy (BSE, or 'mad cow disease') becoming established and spread in the U.S." The Team used an innovative education-oriented partnership program to enforce a FDA regulation designed to control BSE. Compliance rates for the first inspections of all but one industry segment equaled or exceeded 75 percent. Compliance rates at follow-up inspections should approach the goal of 100 percent compliance, based on the enforcement strategy developed and updated jointly by the partners. Independent research has shown that major industry adjustments have been made to facilitate compliance with the regulations. FDA and State inspectors have conducted an unprecedented number of education-oriented inspections; a reinvented approach to doing inspections that has resulted in 70 percent savings in the cost of inspections, amounting to $1.3 million in Fiscal Year 1999.

The Hammer Award is the down-to-earth symbol of the National Partnership for Reinventing Government, a five-year old, major initiative to make the government work better for less. The program honors Federal employees and their partners who have joined forces to streamline procedures, put consumers first, and help build a better and more cost-effective government.

In addition to a plain carpenter's hammer, the award includes a ribbon and the Vice President's note of appreciation, all set in an aluminum frame. Also, every Team member will receive a personal certificate of appreciation with Al Gore's signature and a lapel hammer pin.


--------------------------------------------------------------------------------

Issued by:
FDA, Center for Veterinary Medicine,
Office of Management and Communications, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (301) 827-3800 FAX: (301) 827-4065
Internet Web Site: http://www.fda.gov/cvm


http://www.fda.gov/cvm/CVM_Updates/HAMMERUP.html


PRODUCT
Loweís 40% Hog Concentrate - swine feed for mixing grower and
finisher rations, in 50-pound bulk bags.
Recall #V-057-0.
CODE
All codes between August 1, 1999 and November 23, 1999.
MANUFACTURER
Lowe's Feed & Grain, Inc., Bowling Green, Kentucky.
RECALLED BY
Manufacturer, by letter dated November 18, 1999, and by
telephone. Firm-initiated recall complete.
DISTRIBUTION
Ohio.
QUANTITY
12.46 tons were distributed.
REASON
Product contained protein derived from mammalian tissue and
according to regulation must bear the statement "Do not feed to
cattle or other ruminants" on the label. This regulation is
designed to prevent the establishment and amplification of BSE
through feed. This statement does not appear on the label.


http://www.fda.gov/bbs/topics/ENFORCE/ENF00623.html

2001


October 30, 2001

RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES


http://www.fda.gov/cvm/CVM_Updates/bseoctup.htm


October 10, 2001

FDA HOLDING PUBLIC HEARING ON RUMINANT FEED (BSE) RULES

The Food and Drug Administration (FDA) is holding a public hearing to solicit information and views on its present animal feeding regulation "Animal Proteins Prohibited in Ruminant Feed" -- Code of Federal Regulations, Title 21, Part 589.2000. The purpose of the rule is to help prevent the establishment and amplification of bovine spongiform encephalopathy (BSE) in U.S. cattle herds through feed and thereby help minimize any risks from BSE to animal or human health.

FDA recognizes that new information has emerged on BSE and variant Creutzfeldt-Jakob Disease (vCJD) since the rule went into effect in 1997. Therefore, FDA is requesting information and views from individuals and organizations on the present rule and whether changes in the rule or other additional measures are necessary. The Agency is particularly interested in soliciting comments and views from individuals, industry, consumer groups, health professionals, and researchers with expertise in BSE and related animal and human diseases. ...snip

http://www.fda.gov/cvm/CVM_Updates/part15.htm

September 25, 2001

BSE INSPECTION CHECKLIST AVAILABLE ON THE CVM INTERNET HOME PAGE


FDA's Center for Veterinary Medicine (CVM) has made available the Bovine Spongiform Encephalopathy (BSE) Inspection Checklist on the Center's Home Page on the Internet. This checklist is to be used by Federal and State inspectors to determine compliance with FDA's ruminant feed (BSE) regulations, Code of Federal Regulations, Title 21, Part 589.2000.
This rule, that prohibits the use of most mammalian protein in feeds for ruminant animals, was implemented to prevent the establishment and amplification of BSE through feed in the United States. The rule became effective on August 4, 1997. Inspections of over 10,000 renderers, feed mills, ruminant feeders, and others (such as protein blenders) have been conducted to determine compliance with the BSE feed regulations. The majority of these inspections (around 80%) were conducted by State officials and the remainder by FDA. A checklist has been used to record information on the compliance with the rules. The checklist that is being made available on the CVM Home Page is a revised version intended for use in future inspections.

http://www.fda.gov/cvm/CVM_Updates/bsecheck.htm

CVM Update
July 7, 2001

RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES


http://www.fda.gov/cvm/CVM_Updates/bse72001.htm

CVM Update
March 23, 2001

RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES

http://www.fda.gov/cvm/CVM_Updates/bsemar3.htm

CVM Update
January 10, 2001

UPDATE ON RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES

http://www.fda.gov/cvm/CVM_Updates/bseup.htm

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II_______________________
PRODUCT
Red Cell, Iron Rich Homogenized, Yucca Flavored Vitamin-Iron-Mineral
Supplement for all classes of horses. For Animal Use Only. NET
CONTENTS: 1 GALLON. HORSE HEALTH Products, A Division
of Farnam Companies, Inc. PO Box 34820, Phoenix AZ 85067-4820,
Recall # V-002-2.
Redglo, EQUICARE (brand), Homogenized Energy Building Liquid Multi-
Vitamin Supplement for Horses. EQUICARE PRODUCTS, A
Division of Farnam Companies, Inc., PO Box 34820, Phoenix, AZ,
Recall # V-003-2.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Farnam Companies, Inc., Phoenix, Arizona, sent a recall letter dated
March 8, 2001, to all distributors via regular first class mail. Firm
initiated recall is ongoing.
REASON
The products contain protein material derived from
bovine mammalian tissues; however, the bags are not labeled with the
required BSE cautionary statement.
VOLUME OF PRODUCT IN COMMERCE
14,000 to 15,000 gallons.
DISTRIBUTION
Nationwide.http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00719.html


RECALL NUMBER, PRODUCT AND CODE:
Ruminant Custom Mix Feeds:
V-388-1 "Beef Feed" manufactured with Buckeye 40% Beef
Finisher Pellets, Item 40950.
V-389-1 "Rita's Goat Feed" manufactured with Buckeye 39% Lamb
Conc. Pellets, Item 41250.
V-390-1 "Calf-Beef/Dairy Feed" manufactured with Buckeye 32%
Golden Expectation Pellets, Item 42150
V-391-1 "Feed with Vitamin A" manufactured with Buckeye
Vitamin A-30, Item 1614
V-392-1 "Feed/A-D-E Premix" manufactured with Buckeye A-D-E
Mix, Item 152850
V-409-1 "Calf Feed" manufactured with Buckeye 32% Calf Grower
Concentrate, Item 42350

Non-Ruminant Custom Mix Feeds:
V-393-1 "40% Poultry Feed" manufactured with Buckeye 40%
Poultry Concentrate Crumbles, Item 12100
V-394-1 "40% Hog Feed" manufactured with Buckeye 40% Gro'Em
Lean, Item 20550
V-395-1 "Horse Premium Mixer" manufactured with Buckeye 32%
Premium Mixer Pellets, Item 38000
Code: All bulk custom mix feeds manufactured prior to April 20, 2001.
The customer invoices indicate the type of Buckeye supplement used in the
bulk feed.
REASON:
The bulk custom mix feeds were prepared with ruminant feed supplements
recalled by Buckeye Nutrition due to contamination with protein derived
from mammalian tissues. The non-ruminant bulk custom mix feeds were not
labeled with the required BSE caution statement "Do Not Feed to Cattle or
Other Ruminants."
MANUFACTURER/RECALLING FIRM:
Ferrin Cooperative Equity Exchange, Inc., Carlyle, Illinois
RECALLED BY:
The firm , by letter beginning on June 28, 2001.
FIRM INITIATED RECALL:
Ongoing.
DISTRIBUTION:
IL
QUANTITY:
169 tons of ruminant feeds and 27 tons of non-ruminant feeds

END OF ENFORCEMENT REPORT FOR October 10,
2001.


####

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00714.html


RECALL NUMBER, PRODUCT AND CODE:
Recall # Product
V-397-1 Hyland Floating Fishfood, in 50 pound bags
V-398-1 Endurance Plus Extrude Horse Feed, in 50 pound bags
V-399-1 Seminole Ultra Bloom Horse Feed, in 50 pound bags
V-400-1 Wheat Flakes, extruded product in bulk, not bagged
V-401-1 Corn Flakes, extruded product in bulk, not bagged
V-402-1 Capt. Crunch, extruded product in bulk, not bagged
V-403-1 Green Corn Puffs, extruded product in bulk, not bagged
V-404-1 Orange Corn Puffs, extruded product in bulk, not
bagged
V-405-1 Whole Kernel Corn, in 50 pound bags, unlabeled
V-406-1 Soybean Meal, in bulk, not bagged, unlabeled
ALL CODES
REASON:
The animal feed products may contain proteins derived from mammalian tissues.
The products are not labeled with the required BSE caution statement "Do Not
Feed to Cattle or Other Ruminants."
MANUFACTURER/RECALLING FIRM:
The Hyland Company, Ashland, Kentucky
RECALLED BY:
Manufacturer, by telephone on July 25, 2001, and letters on July 31, 2001.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
KY, GA, NC, FL WV
QUANTITY:
568 tons


END OF ENFORCEMENT REPORT FOR August 29, 2001.

####


http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00708.html

RECALL NUMBER, PRODUCT AND CODE:
V-385-1 - Rock-N-Rooster Competition Blend, lots:
K01611 K01719 K01912 K01916 K02012 K02015
K02214 K02310 K02314 K02318 K02519 K02615
K02917 K03018 K03114 K03215 K03316 K03413
K10116 K10119 K10219 K10313 K10417 K10610
K10714 K10914 K11115 K11214 K11412 K11512
K02019 K02813 K03516 K10616 K11515
V-386-1 - Rock-N-Rooster Premium Five-Grain Scratch, lots:
K01611 K01715 K01718 K01812 K01912 K01916
K02012 K02015 K02019 K02117 K02214 K02310
K02318 K02513 K02518 K02710 K02719 K02813
K02910 K02917 K03011 K03018 K03114 K03215
K03413 K03418 K03516 K03517 K10012 K10013
K10115 K10119 K10219 K10310 K10312 K10410
K10611 K10614 K10616 K10713 K10810 K10812
K10914 K10919 K11012 K11114 K11115 K11216
K11213 K11214 K11315 K11412 K11419 K11512
K01918 K02314 K02814 K03316 K101121
K10510 K10819 K11211 K11515
V-387-1 - Rock-N-Rooster Maintainer, lots:
K01611 K01719 K01812 K01912 K01916 K01918
K02015 K02117 K02314 K02318 K02513 K02519
K02813 K02814 K02917 K03011 K03018 K03114
K03316 K03413 K03418 K03514 K03516 K03517
K10116 K10119 K10219 K10312 K10417 K10512
K10617 K10714 K10810 K11012 K11115 K11211
K11315 K11512 K11515 K02012 K02615 K03215
K10012 K10616 K11214
REASON:
The product contained prohibited material; however, the bags were not labeled
with the required BSE cautionary statement.
MANUFACTURER/RECALLING FIRM:
Southern States Cooperative, Inc., Richmond, Virginia
RECALLED BY:
The recalling firm ceased distribution on June 6, 2001, and notified feed mill
distributors and distribution points by e-mail on June 6 and 7, 2001, to stop
sale and notify their retail customers of the stop sale and provide further
instructions for relabeling of any of the affected inventory. The firm sent
labels with the cautionary statement to their consignees.
FIRM INITIATED RECALL:
ONGOING
DISTRIBUTION:
KY, VA, MD, WV, NC, SC, GA, AL, DE, FL, MS and TN
QUANTITY:
962 tons


END OF ENFORCEMENT REPORT FOR August 1, 2001.


http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00704.html


RECALL NUMBER, PRODUCT AND CODE:
V-353-1 through V-370-1,
Chicken feed products:
Recall # Tag # Product
V-353-1 587 B. Challenger Scratch Feed
V-354-1 588 B. 18% Gamebird Conditioner
V-355-1 2060 B. Kickin' Chicken Premium Game Cock Feed
V-356-1 2066 B. Kickin' Chicken Premium Gamebird 16%
V-357-1 586 B. Scratch Grain
V-358-1 2051 B. Pit Performer 17%
V-359-1 575 B. Classic Yard Feed
V-360-1 576 Eliminator Maintainer
V-361-1 578 Eliminator Conditioner
V-362-1 586 Producer Scratch Grain
V-363-1 4587 Producer 12% Gamebird Yard Feed
V-364-1 2065 Cleveland Trophy Cock Feed
V-365-1 80181AAA Consolidated Hen Scratch
V-366-1 2051 B&B Maintenance 12
V-367-1 2052 B&B Conditioner 14
V-368-1 2050 B&B Scratch 10
V-369-1 4590 Kingsport Original Prater Mix
V-370-1 2062 PC 10 (unlabeled bags)
ALL CODES
The "B" indicates that the Burkmann Feeds brand name is listed on the tag
labels. The suspect products are also bagged and distributed under the
following private labels:
Producer Feeds, Louisville, Kentucky
Kingsport Milling, Kingsport, Tennessee
Consolidated Nutrition, L.C., Omaha, Nebraska
B&B Feeds, Knoxville, Tennessee
Eagle Roller Mill Co., Inc., Shelby, North Carolina
Central Farm Supply of Kentucky, Inc., Louisville, Kentucky
REASON:
The chicken feed products may contain proteins derived from mammalian tissues.
The products are not labeled with the required BSE caution statement "Do Not
Feed to Cattle or Other Ruminants."
MANUFACTURER/RECALLING FIRM:
Burkmann Feeds, London, Kentucky
RECALLED BY:
On May 5, 2001, the firm mailed recall letters with attached BSE sticker-labels
to all customers outside the state of Kentucky. The recall notices were hand-
delivered to customers within the state of Kentucky by Burkmann's Sales
Representatives. Customers were asked to complete and return a recall response
form that was included with each letter documenting the numbers of bags and
varieties of products for which the customers affixed the BSE sticker-labels.
The firm expanded their recall on May 10, 2001, and mailed recall letters with
BSE labels and response forms to the affected customers.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
KY, GA, NC, TN, VA
QUANTITY:
933 tons
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
V-377-1, Renner’s brand 45% meat and bone meal, packed in 100 pound bags.
REASON:
The product contained protein material derived from bovine mammalian tissues;
however, the bags are not labeled with the required BSE cautionary statement.
MANUFACTURER/RECALLING FIRM:
F. W. Renner & Sons, Inc., Canton, Ohio
RECALLED BY:
The recalling firm contacted the consignees by telephone on June 19, 2001.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
OH
QUANTITY:
2,500 lbs
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
V-378-1 to V-384-1, RenPro 58% (brand name) swine and poultry feeds in bulk, as
follows:
V-378-1 - Poultry Layer #215 - guaranteed analysis 15% crude protein, 3% crude
fat, and 3.5% crude fiber.
V-379-1 - Poultry Layer #216 - guaranteed analysis 16% crude protein, 3% crude
fat, and 3.5% crude fiber.
V-380-1 - Poultry Layer #217 - guaranteed analysis 17% crude protein, 3% crude
fat, and 3.5% crude fiber.
V-381-1 - Poultry Layer #218 - guaranteed analysis 18% crude protein, 3% crude
fat, and 3.5% crude fiber.
V-382-1 - Poultry Layer #219 - guaranteed analysis 19% crude protein, 3.5% crude
fat, and 4% crude fiber.
V-383-1 - Poultry Prelay #115 - guaranteed analysis 16% crude protein, 3% crude
fat, and 5% crude fiber.
V-384-1 - Poultry Developer #110 - guaranteed analysis 14% crude protein, 3%
crude fat, and 5.5% crude fiber.
MANFACTURER:
Esbenshade Mills, Mount Joy, PA
RECALLED BY:
On 5/24/01, the manufacturer notified their customers of the labeling
requirement via letter.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
PA
QUANTITY:
None. The product turn over is two weeks or less.


END OF ENFORCEMENT REPORT FOR July 25, 2001.


http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00703.html

RECALL NUMBER, PRODUCT AND CODE:
V-371-1, Tender Lean/Shelled Corn Cattle Feed Mix, a custom
animal feed mix, packed in 80 LB bags. CODES: None. The bags are
unlabeled. The feed was manufactured on 5/14/2001.
REASON:
The cattle feed (for ruminant animals)may contain protein derived from
mammalian tissues.
MANUFACTURER/RECALLING FIRM:
Champaign Landmark, Inc., Urbana, Ohio
RECALLED BY:
On 5/24/2001, the firm's Feed Manager personally visited the sole
farmer/consignee, at which time, he hand-delivered the firm's recall
letter.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
Ohio
QUANTITY:
2,000 LBS


END OF ENFORCEMENT REPORT FOR July 11, 2001.


http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00701.html

RECALL NUMBER, PRODUCT AND CODE:
V-352-1, Bulk Lamb Meal, All lots of bulk lamb meal shipped by the recalling
firm
REASON:
The product is not labeled with the required caution statement “Do not feed to
Cattle or other Ruminants.”
MANUFACTURER/RECALLING FIRM:
International Proteins Corporations (IPC), St. Paul MN
RECALLED BY:
Recalling Firm, Revised labeling by letter on April 17, 2001.
FIRM INITIATED RECALL:
Ongoing.
DISTRIBUTION:
MN, IL, MO, AR and TX
QUANTITY
3,094 tons

END OF ENFORCEMENT REPORT FOR July 04, 2001.


http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00700.html


PODUCT:
Bulk Lamb Meal. Recall Number V-052-1.
CODES:
All lots of bulk lamb meal shipped by the recalling firm.
MANUFACTURER:
International Proteins Corporations (IPC), St. Paul, Minnesota.
RECALLED BY:
Manufacturer, sent revised labeling in a letter on April 17, 2001. Firm
initiated recall is ongoing.
DISTRIBUTION:
MN, IL, MO, AK, TX.
QUANTITY:
3,094 tons.
REASON:
The product is not labeled with the required caution statement "Do Not Feed to
Cattle or Other Ruminants."


END OF ENFORCEMENT REPORT FOR June 20, 2001.


http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00698.html

RECALLS AND FIELD CORRECTIONS: VETMED -- CLASS IIPRODUCT & CODES:
Animal feed products, packaged in 5, 25, 50, and 55 pound bags, and in bulk,
intended for both ruminant and non-ruminant animals. The products are as
follows:
Recall # V-195-1 through V-350-1.

RUMINANT FEED PRODUCTS:

RECALL NO. PRODUCT NO. PRODUCT NAME

V-195-1 40150 B. 30% Calf Pellet
V-196-1 40250 B. 16% Calf Pellet
V-197-1 40350 B. 16% Calf Ration
V-198-1 40450 B. 18% Calf Starter
V-199-1 40600 B. 38% Dairy Pellet
V-200-1 40650 B. 38% Dairy Pellet
V-201-1 40750 B. 16% Dairy Feed
V-202-1 40950 B. 40% Beef Pellet
V-203-1 41150 B. 18% Lamb Starter Pellet
V-204-1 41250 B. 39% Lamb Conc. Pellet
V-205-1 41350 B. 14% Lamb & Beef Pellet
V-206-1 41450 B. 16% Goat Feed
V-207-1 42150 B. 32% Expectation Pellet
V-208-1 42250 B. Llama & Alpaca Pellet
V-209-1 42350 B. 32% Calf Grower Pellet
V-210-1 42650 B. Llama & Alpaca Crums
V-211-1 42750 B. 38% Hay Booster 2
V-212-1 42850 B. 25% Pasture Booster
V-213-1 43100 B. 16% Grower/Dev Pellet
V-214-1 43150 B. 16% Grower/Dev Pellet
V-215-1 43700 WH 32% Calf Gro Pellet
V-216-1 43750 WH 32% Calf Gro Pellet
V-217-1 43850 B. 38% Dairy Mix
V-218-1 44250 B. 17% Doe Pellet
V-219-1 44350 B. 21% Buck Pellet
V-220-1 44450 Legends Ranch Pellet
V-221-1 44500 Legends 17% Breeder Pellet
V-222-1 1652 B. Vitamin E-20
V-223-1 1614 B. Vitamin A-30
V-224-1 44550 Legends 17% Breeder Pellet
V-225-1 44650 Legends 13.5% Rut Pellet
V-226-1 44750 Deer Starter (J)
V-227-1 44940 Llama Premix (J) FSC
V-228-1 45150 Empire 25% Calf Pellet
V-229-1 45450 Berry Llama Pellet
V-230-1 45950 50% Beef Conc. (Meal)
V-231-1 46250 B. 12% Sweet Livestock
V-232-1 46350 B. 1440 Bovatec Pellet
V-233-1 46400 Liberty 38% Dairy Pellet
V-234-1 46450 Liberty 38% Dairy Pellet
V-235-1 47150 B. 14% Gold-n-Grower
V-236-1 47250 B. 12% Gold-n-Conditioner
V-237-1 47450 B. 18% Gold-n-Lamb
V-238-1 47800 Homeworth Dairy Pellet
V-239-1 47850 Homeworth Dairy Pellet
V-240-1 47900 B. 36% Hi Fat Dairy Pellet
V-241-1 47950 B. 36% Hi Fat Dairy Pellet
V-242-1 48550 B. 16% Calf Pellet CA
V-243-1 49200 Mastead Dairy Base
V-244-1 49300 KLEJKA Dairy Base
V-245-1 49650 Deer Premix (J) HFB
V-246-1 49750 39% Lamb Premix (J) HFB
V-247-1 49850 Lamb Starter Premix (J) HFB
V-248-1 120850 Brood Cow Deluxe Mineral
V-249-1 152850 B. A-D-E Mix

NON-RUMINANT FEED PRODUCTS:

V-250-1 10150 B. Miracle Starter
V-251-1 10350 B. 21% Broiler Starter
V-252-1 10450 B. Pullet Grower & Developer
V-253-1 10550 B. 18% Layer Breeder Pellets
V-254-1 10750 B. 20% Gold Std. Laying Crum
V-255-1 10950 B. 17% Complete Laying Crums
V-256-1 11050 B. 16% Prosperity Layer Crums
V-257-1 11100 B. 40% Poultry Concentrate
V-258-1 11150 B. 40% Poultry Concentrate
V-259-1 11250 B. 28% Turkey Starter Crums
V-260-1 11350 20% Gig "4" Pellets
V-261-1 11450 B. 16% Prosperity Layer Pellets
V-262-1 11550 18% Game Bird Breeder Pellets
V-263-1 11650 B. 19% Ratite Grower Diet
V-264-1 11750 B. 23% Ratite Breeder Diet
V-265-1 12100 B. 40% Poultry Concentrate Crums
V-266-1 12550 B. 32% Base Poultry Mix
V-267-1 13250 B. 28% Turkey Starter
V-268-1 13450 B. 20% Poultry Grower
V-269-1 14325 B. Game Bird Mix - Coarse
V-270-1 20150 B. 18% Pig Starter Pellets
V-271-1 20250 B. 16% Pig Grower Pellets
V-272-1 20450 B. 14% Porkmaker 100 Pellets
V-273-1 20550 B. 40% Gro 'Em Lean
V-274-1 21850 B. 27% Hi-Fat Swine Base
V-275-1 23000 Mt. Hope Hevy Hog
V-276-1 30050 12% Pleasure Horse - Sweet
V-277-1 30150 Alfa + Performer 10 Sweet
V-278-1 30250 14% Grass + Perf Sweet
V-279-1 30450 12% Wrangler - Complete
V-280-1 30550 B. 12% Pleasure Horse Pellets
V-281-1 30650 B. 32% Gro' N Win Pellets
V-282-1 30750 12% Wrangler Cubes
V-283-1 30950 18% Foal Starter
V-284-1 31050 B. 14% Alfa + Dev Pellets
V-285-1 31150 B. Alfa + Performer 10 Pel
V-286-1 31200 Grass +Performer 14 Pel
V-287-1 31250 Grass +Performer 14 Pel
V-288-1 31350 12% Mustang
V-289-1 31450 Endurance - 101 Extruded
V-290-1 31550 B. Equine Energy - UK
V-291-1 31650 B. 16% Grass + Dev Pellets
V-292-1 31750 16% Grass + Dev Cubes
V-293-1 31850 16% Grass + Dev Sweet
V-294-1 31950 B. 11% Alfa Gro 'N Win Pel
V-295-1 32050 B. Sho' Win Pellets
V-296-1 32250 B. Senior Formula
V-297-1 32350 Oscar Horse Mix
V-298-1 32450 B. Ultimate Finish
V-299-1 32550 Crossfire Horse Feed
V-300-1 32650 B. Equine 16% Growth
V-301-1 32750 B. Reduced Energy Formula
V-302-1 32850 B. Training Formula
V-303-1 32950 B. Cadence Formula
V-304-1 33150 B. Track 12 Horse Feed
V-305-1 33350 Spears 16% GR + Dev Cubes
V-306-1 33400 B. 14% Supreme Horse Pellets
V-307-1 33450 B. 14% Supreme Horse Pellets
V-308-1 33650 B. Race'N Win
V-309-1 33750 B. 14% Prominent Horse Feed
V-310-1 33850 B. Unbeetable Horse Feed
V-311-1 34750 Cargill Senior Horse
V-312-1 34850 Cargill Vitality Gold
V-313-1 35150 Chagrin 12% Sweet Fd
V-314-1 35250 Smith Pure Pleasure
V-315-1 35750 Roundup 10% Horse Pellets
V-316-1 35850 12% Summerglo Horse
V-317-1 36255 B. Grass +Min&VitBase - Mexico
V-318-1 36850 Miller's 12% Horse Feed
V-319-1 37155 B. Gro'Win Base Mix - Mexico
V-320-1 38000 B. 32% Premium Mixer Pellets
V-321-1 38050 B. 32% Premium Mixer Pellets
V-322-1 38100 36% Maintenance Mixer Pellets
V-323-1 38150 36% Maintenance Mixer Pellets
V-324-1 50150 Terramycin Crumbles
V-325-1 60105 16% Rabbit Pellets
V-326-1 60125 16% Rabbit Pellets
V-327-1 60150 B. 16% Rabbit Pellets
V-328-1 60205 18% Rabbit Developer
V-329-1 60250 B. 18% Rabbit Developer
V-330-1 60450 B. 16% Rabbit Maintenance
V-331-1 90150 B. Buckeye Scratch
V-332-1 90225 Gold Standard Scratch
V-333-1 90250 Gold Standard Scratch
V-334-1 90350 Intermediate Scratch
V-335-1 90450 B. Chick Grains
V-336-1 90525 B. Shelled Corn
V-337-1 90550 B. Shelled Corn
V-338-1 90650 B. Cracked Corn
V-339-1 90825 B. Fine Cracked Corn
V-340-1 90850 B. Fine Cracked Corn
V-341-1 91000 Steam Flaked Corn
V-342-1 91050 Steam Flaked Corn
V-343-1 91750 Oats - HP Crimped
V-344-1 91850 B. HP Sweet Crimped Oats
V-345-1 95550 Land O' Lakes Shelled Corn
V-346-1 95650 Land O' Cracked Corn
V-347-1 95850 Land O' Lakes Chick Crack
V-348-1 100850 B. Alfalfa Pellets
V-349-1 101850 Cooked Full Fat Soybean
V-350-1 122200 Magnatone M-4-B Pels Bulk
MANUFACTURER:
Buckeye Feed Mills, Dalton, Ohio.
RECALLED BY:
Manufacturer visited local customers on April 17, 2001. On April 18 and 19,
2001, manufacturer mailed and faxed recall notices. Firm initiated recall is
ongoing.
DISTRIBUTION:
Al, CT, DE, FL, GA, IL, IN, IA, KY, ME, MD, MA, MO, MN, MS, NH, NJ, NY, NC, OH,
OR, PA, RI, TN, VA, WV, and WI.
QUANTITY:
2,790 tons of ruminant feed products and 14,000 tons of non-ruminant feed
products.
REASON:
The animal feed products may contain protein derived from mammalian tissues.

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00696.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00694.html RECALLS AND FIELD CORRECTIONS: VETERINARY MEDS -- CLASS II
PRODUCT:
Buckeye 26% Hi Fat Swine Mix, Sandy Lake 40% Hog Supplement, 100 lb. containers,
flexible plastic burlap bags. Recall #V-026-1.
CODE:
None are used.
MANUFACTURER:
Sandy Lake Mills, Sandy Lake, PA.
RECALLED BY:
Manufacturer, by telephone and visit. Firm initiated recall complete.
DISTRIBUTION:
Pennsylvania.
QUANTITY:
Seven containers, each weighing 100 pounds.
REASON: The product contains prohibited material (ruminant
animal proteins) used as an ingredient in the finished product swine feed. The
product is not labeled with the required caution statement "Do Not Feed to
Cattle or Other Ruminants."
________
PRODUCT:
Custom Vaquero Supplement for Cattle identified by Purina Mills. Recall #V-027-
1.
CODE:
7V87.
MANUFACTURER:
Purina Mills, Inc., Gonzalez, Texas.
RECALLED BY:
Manufacturer, contacted the one consignee on January 17, 2001.
DISTRIBUTION:
Texas.
QUANTITY:
44,355 pounds.
REASON:
The ruminant feed product contains meat and bone meal (MBM) of bovine origin.http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00692.html PRODUCT:
a) Manna Pro Floating Fish Food for Catfish . Recall #V-028-1;
b) Manna Pro Floating Fish Food - 26% For All Freshwater Fish.
Recall #V-029-1.
Both are packaged in 50 pound, plastic-lined, paper sacks.
CODE:
a) 10160164, 12090164, 01050264, 03020264, and 03140264;
b) 09110164, 09190164, 09230164, 10090164, 10160164, 11170164,
12090164 and 3200264.
MANUFACTURER:
Doane Pet Care, Brentwood, Tennessee.
RECALLED BY:
Manufacturer, by telephone on March 26, 2001. Firm-initiated recall complete.
DISTRIBUTION:
California, Pennsylvania, Ohio, Kansas, Colorado, Georgia, and Florida.
QUANTITY:
27,300 pounds of Catfish Food and 86,100 pounds of Freshwater Fish.
REASON:
The products, which contain meat by-products, were shipped without the
required BSE warning label.http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00691.html


PRODUCT:
Buckeye 40% Poultry Concentrate. Recall #V-016-1.
CODES:
The bags are uncoded. Firm is recalling product manufactured since
December 1998; however, they are only completing field corrections on
product manufactured within the last six months (November 2000).
MANUFACTURER:
Yachere Feed, Inc. Rockwood, Pennsylvania.
RECALLED BY:
Manufacturer, by visit on 3/19/01 and 3/20/01. Firm-initiated recall
complete.
DISTRIBUTION:
Pennsylvania.
QUANTITY:
Nine containers, each weighing 100 pounds.
REASON:
The animal feed contains product derived from mammalian tissues and
must bear the statement "Do not feed to cattle or other ruminants"
on the label to prevent the establishment and amplification of BSE
through feed. This statement does not appear on the label.
________
PRODUCT:
"Our Own Pig & Hog Grower" hog feed, packaged in 50 pound bags, with
paperboard tags sewn onto the bags. Recall #V-017-1.
CODES:
The bags are uncoded.
MANUFACTURER:
The Perry Coal and Feed Company, Perry, Ohio.
RECALLED BY:
Manufacturer, by telephone on March 22, 2001. Firm-initiated
recall complete.
DISTRIBUTION:
Ohio.
QUANTITY:
Approximately 350 pounds of hog feed (7/50 pound bags).
REASON:
The animal feed contains protein derived from mammalian tissues
and must bear the statement "Do not feed to cattle or other
ruminants" on the label to prevent the establishment and
amplification of BSE through feed. This statement does
not appear on the label.


http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00690.html


RECALLS AND FIELD CORRECTIONS: VETENIARY MED -- CLASS II

PRODUCT:
Custom Mixed Poultry Feed, bagged and sold as bulk,
unlabeled poultry feed. Recall #V-014-1.
CODE:
The bags are uncoded.
MANUFACTURER:
Western Reserve Farm Coop., Middlefield, Ohio.
RECALLED BY:
Manufacturer, by telephone on February 28, 2001.
Firm-initiated recall complete.
DISTRIBUTION:
Ohio.
QUANTITY:
Approximately 820 pounds.
REASON:
The animal feed contains product derived from mammalian
tissues and must bear the statement “Do not feed to cattle
or other ruminants” on the label to prevent the establishment
and amplification of BSE through feed. This statement does not
appear on the label.
________
PRODUCT:
Custom Mixed Poultry Feed, packaged in unlabeled 100
pound bags and sold in bulk. Recall #V-015-1.
CODE:
The bags are uncoded.
MANUFACTURER:
Medina Landmark, Inc., Medina, Ohio.
RECALLED BY:
Manufacturer, by telephone on March 5, 2001.
Firm-initiated recall complete.
DISTRIBUTION:
Ohio.
QUANTITY:
Approximately 900 pounds of feed (9/100 pound bags).
REASON:
The animal feed contains product derived from mammalian
tissues and must bear the statement “Do not feed to cattle
or other ruminants” on the label to prevent the establishment and
amplification of BSE through feed. This statement does
not appear on the label.


END OF ENFORCEMENT REPORT FOR APRIL 11, 2001.

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00688.html


2002


To help prevent the establishment and amplification of

BSE through feed in the United States, FDA implemented

a final rule that prohibits the use of most mammalian

protein in feeds for ruminant animals. This rule, Title

21 Part 589.2000 of the Code of Federal Regulations, became

effective on August 4, 1997. To date, active monitoring

by the U.S. Department of Agriculture (USDA) has found

no cases of bovine spongiform encephalopathy (BSE) in

U.S. cattle. This is an update on FDA enforcement activities

regarding the ruminant feed (BSE) regulation.

FDA’s enforcement plan for the ruminant feed regulation

includes education, as well as inspections, with FDA

taking compliance actions for intentional or repeated noncompliance.

FDA’s Center for Veterinary Medicine (CVM)

has assembled data from the inspections that have been

conducted AND whose final inspection report has been

submitted to CVM (i.e., “inspected/reported”) as of March

11, 2002. There is a lag time between the completion of

an inspection and the submission of a final inspection report

to CVM. This lag period includes the time required to

conduct quality assurance on the report and to evaluate

the findings before a final report is submitted.

As of March 11, CVM had received inspection reports

covering inspections (both initial inspections and re-inspections)

of 10,458 different firms. The majority of these in-

RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES

http://www.fda.gov/cvm/Documents/MayJune.pdf


July/August 2002

The following individuals/firms received warning

letters for violations related to 21 CFR Part 589.2000 –

Animal Proteins Prohibited in Ruminant Feed. This regulation

is intended to prevent the establishment and

REGULATORY ACTIVITIES

by Karen A. Kandra

amplification of Bovine Spongiform Encephalopathy

(BSE):

• Jeffrey T. Buck, Owner, All American Feed & Tractor,

Sandpoint, ID

• Kenneth M. Van Dyke, President, Van Dyke Grain

Elevators, Inc., North Plains, OR

• Philip C. Anderson, General Manager, Darling International,

Inc., Tacoma, WA

Violations included failure to maintain sufficient

records and written procedures to prevent cross-contamination;

failure to keep written procedures for cleaning

out or flushing equipment after mixing feeds containing

prohibited material; failure to provide written

procedures for separating products that contain or

may contain prohibited material from ingredients

used in ruminant feeds, from the time of receipt until

the time of shipment; and, failure to label meat

and bone meal with the required cautionary statement

“Do Not Feed to Cattle or Other Ruminants.”


snip...

http://www.fda.gov/cvm/Documents/JulyAugust.pdf

November 12, 2002

MATERIAL FROM CWD-POSITIVE ANIMALS SHOULD NOT BE USED FOR ANIMAL FEED

This CVM Update has been _withdrawn_ by Draft Guidance for Industry #158: Use of Material from Deer and Elk in Animal Feed | doc| | pdf |, May 14, 2003

See CVM Update Draft Guidance on Use of Material from Deer and Elk in Animal Feed Available for Comment; CVM Updates on Deer and Elk in Animal Feed Withdrawn.


--------------------------------------------------------------------------------


http://www.fda.gov/cvm/CVM_Updates/CWdup.htm


2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed

EMC 1
Terry S. Singeltary Sr.
Vol #:
1

http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm

CVM Update
Clarification of FDA Position on Use In Animal Feed of Material From Certain Free Range Deer and Elk

This CVM Update has been withdrawn by Draft Guidance for Industry #158: Use of Material from Deer and Elk in Animal Feed | doc| | pdf |, May 14, 2003.

See CVM Update Draft Guidance on Use of Material from Deer and Elk in Animal Feed Available for Comment; CVM Updates on Deer and Elk in Animal Feed Withdrawn.


http://www.fda.gov/cvm/CVM_Updates/CWDNOV21.htm

CONTAINS NON-BINDING RECOMMENDATIONS

158

Guidance for Industry

Use of Material from Deer and Elk in Animal Feed

Comments and suggestions regarding this guidance should be sent to the Division of

Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,

Room 1061, Rockville, MD 20852. Comments may also be submitted electronically on

the Internet at http://www.fda.gov/dockets/ecomments. Once on this Internet site, select

"[03D-0186][Use of Material from Deer and Elk in Animal Feed]" and follow the

directions. All written comments should be identified with Docket No. 03D-0186.

For questions regarding this guidance, contact Burt Pritchett, Center for Veterinary

Medicine (HFV- 222), Food and Drug Administration, 7500 Standish Place, Rockville,

MD 20855, 301-827-0177. E-mail: bpritche@cvm.fda.gov

Additional copies of this guidance document may be requested from the Communications

Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7500

Standish Place, Rockville, MD 20855, and may be viewed on the Internet at

http://www.fda.gov/cvm.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Veterinary Medicine

September 15, 2003

CONTAINS NON-BINDING RECOMMENDATIONS

1

158

Guidance for Industry1

Use of Material from Deer and Elk in Animal Feed

I. Introduction

FDA’s guidance documents, including this guidance, do not establish legally

enforceable responsibilities. Instead, guidances describe the Agency’s current

thinking on a topic and should be viewed only as recommendations, unless

specific regulatory or statutory requirements are cited. The use of the word

“should” in Agency guidances means that something is suggested or

recommended, but not required.

Under FDA’s BSE feed regulation (21 CFR 589.2000) most material from deer and elk is

prohibited for use in feed for ruminant animals. This guidance document describes FDA’s

recommendations regarding the use in all animal feed of all material from deer and elk that

are positive for Chronic Wasting Disease (CWD) or are considered at high risk for CWD.

The potential risks from CWD to humans or non-cervid animals such as poultry and swine

are not well understood. However, because of recent recognition that CWD is spreading

rapidly in white-tailed deer, and because CWD’s route of transmission is poorly

understood, FDA is making recommendations regarding the use in animal feed of rendered

materials from deer and elk that are CWD-positive or that are at high risk for CWD.

II. Background

CWD is a neurological (brain) disease of farmed and wild deer and elk that belong in the

animal family cervidae (cervids). Only deer and elk are known to be susceptible to CWD

by natural transmission. The disease has been found in farmed and wild mule deer,

white-tailed deer, North American elk, and in farmed black-tailed deer. CWD belongs to

a family of animal and human diseases called transmissible spongiform encephalopathies

1 This guidance has been prepared by the Division of Animal Feeds in the Center for Veterinary Medicine

(CVM) at the Food and Drug Administration.

This guidance represents the Food and Drug Administration’s current

thinking on the use of material from deer and elk in animal feed. It does not

create or confer any rights for or on any person and does not operate to bind

FDA or the public. You can use an alternative approach if the approach

satisfies the requirements of applicable statutes or regulations. If you want to

discuss an alternative approach, contact the FDA staff responsible for

implementing this guidance. If you cannot identify the appropriate FDA

staff, call the appropriate number listed on the title page of this guidance.

CONTAINS NON-BINDING RECOMMENDATIONS

2

(TSEs). These include bovine spongiform encephalopathy (BSE or “mad cow” disease)

in cattle; scrapie in sheep and goats; and classical and variant Creutzfeldt-Jakob diseases

(CJD and vCJD) in humans. There is no known treatment for these diseases, and there is

no vaccine to prevent them. In addition, although validated postmortem diagnostic tests

are available, there are no validated diagnostic tests for CWD that can be used to test for

the disease in live animals.

III. Use in animal feed of material from CWD-positive deer and elk

Material from CWD-positive animals may not be used in any animal feed or feed

ingredients. Pursuant to Sec. 402(a)(5) of the Federal Food, Drug, and Cosmetic Act,

animal feed and feed ingredients containing material from a CWD-positive animal would

be considered adulterated. FDA recommends that any such adulterated feed or feed

ingredients be recalled or otherwise removed from the marketplace.

IV. Use in animal feed of material from deer and elk considered at high risk for CWD

Deer and elk considered at high risk for CWD include: (1) animals from areas declared

by State officials to be endemic for CWD and/or to be CWD eradication zones; and (2)

deer and elk that at some time during the 60-month period immediately before the time of

slaughter were in a captive herd that contained a CWD-positive animal.

FDA recommends that materials from deer and elk considered at high risk for CWD no

longer be entered into the animal feed system. Under present circumstances, FDA is not

recommending that feed made from deer and elk from a non-endemic area be recalled if a

State later declares the area endemic for CWD or a CWD eradication zone. In addition,

at this time, FDA is not recommending that feed made from deer and elk believed to be

from a captive herd that contained no CWD-positive animals be recalled if that herd is

subsequently found to contain a CWD-positive animal.

V. Use in animal feed of material from deer and elk NOT considered at high risk

for CWD

FDA continues to consider materials from deer and elk NOT considered at high risk for

CWD to be acceptable for use in NON-RUMINANT animal feeds in accordance with

current agency regulations, 21 CFR 589.2000. Deer and elk not considered at high risk

include: (1) deer and elk from areas not declared by State officials to be endemic for

CWD and/or to be CWD eradication zones; and (2) deer and elk that were not at some

time during the 60-month period immediately before the time of slaughter in a captive

herd that contained a CWD-positive animal. ...snip ;


http://www.fda.gov/cvm/Guidance/guide158.pdf


CVM Update
April 15, 2002

RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES

http://www.fda.gov/cvm/CVM_Updates/bseap02.htm


RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_____________________________
PRODUCT
Land O'Lakes Farmland Feed 32% Grow Big Floater, For Catfish Grown In Ponds or Artificial Culture Systems, packaged in 50-lb. bags, product #1960014, contains animal protein products. Recall # V-003-3.
CODE
None.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Land O'Lakes Farmland Feed LLC, Arden Hills, MN, by fax on August 21, 2002.
Manufacturer: Land O'Lakes Farmland Feed LLC, Kansas City, KS. FDA initiated recall is complete.
REASON
Label lacks BSE warning statement.
VOLUME OF PRODUCT IN COMMERCE
Approx. 18,872/50-lb. bags.
DISTRIBUTION
KS, TX, CO, NE, IL, MO, IA, OK and SD


http://www.fda.gov/bbs/topics/enforce/2002/ENF00765.html

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE--CLASS II
_____________________________
PRODUCT
12% Horse Feed, packaged under the Griffith & Sons label, in 100 lb bags. Recall # V-001-3.
CODE
The bags are not coded. All of their 12% Horse Feed product manufactured and distributed from 5/14/2002 to 6/21/2002 is subject to this recall.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Griffith & Sons Feed and Farm Supply, Staffordsville, KY, by telephone and visits on June 21, 2002.
Manufacturer: Griffith & Sons Feed and Farm Supply, Staffordsville, OH. Firm initiated recall is complete.
REASON
The Horse Feed product contains beef protein and is not labeled with the required BSE cautionary statement.
VOLUME OF PRODUCT IN COMMERCE
1,200 lbs (12 / 100 lb bags).
DISTRIBUTION
OH.


END OF ENFORCEMENT REPORT FOR OCTOBER 09, 2002

####

http://www.fda.gov/bbs/topics/enforce/2002/ENF00764.html

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_______________________
PRODUCT
Product is flavor enhancer intended for use in pet food, labeled in part:
"8280 FLAVOR GENERATOR #1" packaged in 1,000 and 2,000 pound bags.
Recall # V-163-2.
CODE
All lots shipped prior to 04/09/02.
RECALLING FIRM/MANUFACTURER
Roche Vitamins, Inc., Fort Worth, TX, by telephone on April 5, 2002.
FDA initiated recall is complete.
REASON
Product contains beef protein but is not labeled with the warning
statement regarding prohibited for use as feed for ruminants.
VOLUME OF PRODUCT IN COMMERCE
680,200 lbs.
DISTRIBUTION
KS, CA, KY and IN.
http://www.fda.gov/bbs/topics/enforce/2002/ENF00762.html

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II_______________________
PRODUCT
Homestead Poultry Starter Grower Medicated 55 lb. bags. Recall # V-154-2.
CODE
Not coded.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shur-Gain USA Inc., Elma, NY, by visit on June 24, 2002.
Manufacturer: Shur-Gain, St. Marys, Ontario, Canada.
FDA initiated recall is complete.
REASON
Contains ruminant proteins but lacks caution statement.
VOLUME OF PRODUCT IN COMMERCE
31 bags.
DISTRIBUTION
NY.
END OF ENFORCEMENT REPORT FOR AUGUST 14, 2002

####

http://www.fda.gov/bbs/topics/enforce/2002/ENF00756.html RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_______________________
PRODUCT
UNLABELED hog feed in 100 lb. bags containing assorted grains (primarily
corn), and Miller's Hog Supplement 36% protein.
UNLABELED dairy feed in 100 lb. bags, contains assorted grains (primarily
corn), soybeans and molasses. Recall # V-142-2.
CODE
Not CODEd.
RECALLING FIRM/MANUFACTURER
Recalling Firm: R. B. Crowell & Sons/Thompson Grain, Inc., Manchester,
NY, by telephone on May 7 and 8, 2002.
Manufacturer: John R. Power, Palmyra, NY.
State initiated recall is complete.
REASON
Unlabeled animal feeds/possible cross contamination.
VOLUME OF PRODUCT IN COMMERCE
.75 tons per month.
DISTRIBUTION
NY.
_______________________
PRODUCT
Cereal Food Fines - Bulk PRODUCT. Recall # V-145-2.
CODE
All PRODUCT prior to October 2, 2001.
RECALLING FIRM/MANUFACTURER
Souder Feed & Grain Carlisle, PA, by letters dated October 9, 2001.
State initiated recall is ongoing.
REASON
PRODUCT doesn't bear caution statement - do not feed to
cattle or other ruminants.
VOLUME OF PRODUCT IN COMMERCE
6,141 tons.
DISTRIBUTION
MO, NY and PA.http://www.fda.gov/bbs/topics/enforce/2002/ENF00747.html
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_______________________
PRODUCT
BioFlavor F2425, BioFlavor F21002 and BioFlavor C20058. The product,
packaged in 50 lb. bags, is labeled in part, " *** PALATABILITY ENHANCER
INTENDED FOR CAT FOOD USE AT LESS THAN 10% *** INGREDIENT LISTING: ***
Beef Broth *** ". Recall # V-140-2
CODE
Product Codes
F2425 107B-RB-1
107B-RB-2
149C
201D
202C
205D
210A
F21002 143B
143D
146D
144B
144D
139D
142D
150D
151D
152C
152D
201C
205C
206C
208A
211A
C20058 143D
144C
146C
208B
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bioproducts, Inc., Fairlawn, OH, by telephone and letter
on April 5, 2002.
Manufacturer: Bioproducts, Inc., Aurora, MO.
Firm initiated recall is ongoing.
REASON
Animal feed product with beef protein does not contain required BSE
statement on labels.
VOLUME OF PRODUCT IN COMMERCE
354,150 lbs.
DISTRIBUTION
TX, KS, MO and MI.
_______________________
PRODUCT
Steamed Bonemeal in 50-lb. bags, product code C# 13581, packaged under
two different labels: Premium Steamed Bonemeal Manufactured by Buchheit
Premium Feeds, Perryville, MO, and Steamed Bonemeal Manufactured for
Siemer's Enterprises Inc., Teutopolis, IL.
Recall # V-141-2.
CODE
Not coded.
RECALLING FIRM/MANUFACTURER
Buchheit, Inc., Perryville, MO, by telephone on May 14, 2002.
FDA initiated recall is ongoing.
REASON
Label lacks BSE warning statement.
VOLUME OF PRODUCT IN COMMERCE
Approx. 902/50-lb. bags.
DISTRIBUTION
MO and IL.


END OF ENFORCEMENT REPORT FOR JUNE 5, 2002

####

http://www.fda.gov/bbs/topics/enforce/2002/ENF00746.html PRODUCT
The following 10 animal feed products were subject to this recall:
1- Sexton Brothers MIXED FEED-WM, Recall # V-019-2
2- Sexton Brothers 9% SWEET FEED, Recall # V-020-2
3- Sexton Brothers 13% SWEET FEED, Recall # V-021-2
4- Sexton Brothers WHEAT, Recall # V-022-2
5- Sexton Brothers 44% SOYBEAN MEAL, Recall # V-023-2
6- Sexton Brothers 14% GOAT FEED, Recall # V-024-2
7- Sexton Brothers WHEAT MIDDS, Recall # V-025-2
8- Sexton Brothers SHELLED CORN, Recall # V-026-2
9- Sexton Brothers OATS, Recall # V-027-2
10-Sexton Brothers 17% GOAT FEED, Recall # V-028-2
The feed products were packaged in 50 LB bags, under the Willard
Milling Company label.
CODE
No codes.
All recalled products that were distributed prior to July
30, 2001 are affected by this recall.
RECALLING FIRM/MANUFACTURER
Willard Milling, Inc. Willard, KY, by letter and telephone on July 30,
2001. State initiated recall is complete.
REASON
Products may contain protein derived from mammalian tissues.
VOLUME OF PRODUCT IN COMMERCE
Approx. 140 tons
DISTRIBUTION
OH, KY, IN, and WV.


END OF ENFORCEMENT REPORT FOR January 23, 2002


####


http://www.fda.gov/bbs/topics/enforce/2002/ENF00727.html

PRODUCT
The following custom mixed animal feeds are recalled ---
a) [non-ruminant]: Horse Feed, Hog Feed, and 14% Pig Feed.
Recall # V-157-2;
b) [ruminant]: Dairy Feed, Steer Feed, New Goat Feed, Cattle Feed, and
Beef Feed. Recall # V-158-2.
CODE
The product is coded only with the manufacturing date and invoice
numbers. All feed products manufactured and shipped since July 9, 2001
are affected by this recall.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shepard Grain Company, Inc., Urbana, OH, by telephone on
January 11, 2002.
Manufacturer: Shepard Grain Company, Inc., W. Liberty, OH.
FDA initiated recall is complete.
REASON
Ruminant and non-ruminant animal feeds contain BSE prohibited material,
and are either misbranded or adulterated.
VOLUME OF PRODUCT IN COMMERCE
41,129 LBS (20.5 tons).
DISTRIBUTION
OH.


END OF ENFORCEMENT REPORT FOR AUGUST 28, 2002


http://www.fda.gov/bbs/topics/enforce/2002/ENF00758.html

2003

AS at August 8, 2006, the following rules to further enhance safety from feed containing mad cow ingredients were never implemented, just more lies and broken promises to cater to the industry. ...


Bovine Spongiform Encephalopathy

Bovine Spongiform Encephalopathy (BSE), commonly called “Mad Cow Disease” is the name for a slowly progressive, degenerative, fatal disease affecting the central nervous system of adult cattle. Since 1990, the U.S. Department of Agriculture (USDA) has conducted aggressive surveillance of the highest risk cattle going to slaughter in the United States, in which 10,000- 20,000 animals per year have been tested. To date, the only cow that has been found to be affected with BSE was the one diagnosed with BSE in December 2003.

The exact cause of BSE is not known but it is generally accepted by the scientific community that infectious forms of a type of protein, prions, normally found in animals cause BSE. In cattle with BSE, these abnormal prions initially occur in the small intestines and tonsils, and are found in central nervous tissues, such as the brain and spinal cord, and other tissues of infected animals experiencing later stages of the disease.

CVM and Ruminant Feed (BSE) Inspections

To prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE) through animal feed in the United States, FDA implemented a final rule that prohibits the use of most mammalian protein in feeds for ruminant animals. This rule, 21 CFR Part 589.2000 of the Code of Federal Regulations, became effective on August 4, 1997(here called the BSE/Ruminant Feed regulation.) Inspections of renderers, feed mills, ruminant feeders, protein blenders, pet food manufacturers, pet food salvagers, animal feed distributors and transporters, ruminant feeders, and others have been conducted to determine compliance with the BSE/Ruminant Feed regulations.


UPDATE: BSE Found in Washington State

USDA Reports Cow Tested Positive for BSE – FDA Sends Investigators
On December 23, 2003, the U.S. Department of Agriculture (USDA) announced that a Holsteincow in the State of Washingtonhad tested presumptively positive for bovine spongiform encephalopathy (BSE or “mad cow disease”). Following this announcement, FDA dispatched several teams of investigators to trace back and trace forward the potential involvement of any FDA-regulated commodities. USDA, which is responsible for the safety of certain meat and poultry products as well as animal health, led the investigation of this BSE case.

FDA’s primary responsibility related to this investigation involved animal feed, which most experts believe is the main way in which BSE is amplified throughout cattle herds. BSE does not spread naturally from adult cow to adult cow. FDA worked closely with USDA and state officials in this intense investigation.

FDA’s “animal feed” rule, in place since 1997, is designed to prevent the spread of BSE further throughout cattle herds. This regulation prohibits the feeding of most mammalian protein to ruminant animals such as cows, sheep and goats - the route of disease transmission that led to the epidemic of BSE in the United Kingdom, beginning in the 1980’s.

A study published in 2001 by the HarvardCenterfor Risk Analysis identified FDA’s animal feed rule as one of the primary safeguards against the amplification of BSE in the U.S.cattle herd if a case were ever to occur in the U.S.

FDA has vigorously enforced this rule. More than 99 percent of these facilities are currently in compliance with the provisions of this rule to protect the U.S.food supply and its cattle from the agent that causes BSE.

This one case of BSE does not mean that the U.S.food supply is any less safe today than it was yesterday. Concerning the safety of milk, the scientific data indicate that milk from BSE cows does not transmit BSE. National and international public health organizations have consistently stated that milk and milk products are safe regardless of whether the country producing them has had cases of BSE.

On December 27, 2003, FDA announced that its investigators and inspectors from the states of Washington and Oregon had located all of the potentially-infectious product rendered from the one cow that tested positive for BSE in Washington State. The rendering plants that processed all the non-edible material from the BSE cow placed a voluntary hold on all of the potentially-infectious product, none of which left the control of the companies and entered commercial distribution. The firms, located in Washington State and Oregon, assisted and cooperated fully with FDA’s investigation.

FDA Emergency Operations Center

The FDA Emergency Operations Center (EOC), a branch of the OCM, is the single point of coordination for the FDA's response to any BSE emergency. The FDA EOC is the physical facility that serves as the central point for the Agency's response activity. During a BSE emergency, the FDA EOC will coordinate and report on all response activity and interagency communication. The FDA EOC monitors BSE emergencies; triages complaints and alerts; issues assignments to the field; coordinates responses; and communicates with other federal, state, and local agencies as they request technical and material support from the FDA.

The FDA EOC maintains contact with the Department of Health and Human Services (HHS) Secretary's Command Center (SCC), CDC EOC, USDA/FSIS Office of Food Security and Emergency Preparedness, and other EOCs, as appropriate. The FDA EOC will continue to direct and monitor all FDA response activities throughout the life cycle of an emergency.

New Measures to Prevent BSE

Several new public health measures will be implemented by FDA to strengthen significantly the multiple existing firewalls that protect Americans from exposure to the agent thought to cause bovine spongiform encephalopathy (BSE, also known as mad cow disease) and that help prevent the spread of BSE in U.S.cattle.

The existing multiple firewalls, developed by both the U.S.Department of Agriculture (USDA) and HHS, have been extremely effective in protecting the American consumer from exposure to BSE. The first firewall is based on import controls started in 1989. A second firewall is surveillance of the U.S.cattle population for the presence of BSE, a USDA firewall that led to the finding of the BSE cow in December. The third firewall is FDA's 1997 animal feed ban, which is the critical safeguard to help prevent the spread of BSE through cattle herds by prohibiting the feeding of most mammalian protein to ruminant animals, including cattle.

The fourth firewall, recently announced by USDA, makes sure that no bovine tissues known to be at high risk for carrying the agent of BSE enter the human food supply regulated by USDA. The fifth firewall is effective response planning to contain the potential for any damage from a BSE positive animal, if one is discovered. This contingency response plan, which had been developed over the past several years, was initiated immediately upon the discovery of a BSE positive cow in Washington State December 23.

The new safeguards are science-based and further bolster these already effective safeguards.

Specifically, HHS intends to ban from human food (including dietary supplements), and cosmetics a wide range of bovine-derived material so that the same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that FDA regulates.

FDA will also prohibit certain currently allowed feeding and manufacturing practices involving feed for cattle and other ruminant animals. These additional measures will further strengthen FDA's 1997 "animal feed" rule.

To implement these new protections, FDA will publish two interim final rules that will take effect immediately upon publication, although there will be an opportunity for public comment after publication.

The first interim final rule will ban the following materials from FDA-regulated human food, (including dietary supplements) and cosmetics:

Any material from "downer" cattle. ("Downer" cattle are animals that cannot walk.)
Any material from "dead" cattle. ("Dead" cattle are cattle that die on the farm (i.e. before reaching the slaughter plant);
Specified Risk Materials (SRMs) that are known to harbor the highest concentrations of the infectious agent for BSE, such as the brain, skull, eyes, and spinal cord of cattle 30 months or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age or health; and
The product known as mechanically separated beef, a product which may contain SRMs. Meat obtained by Advanced Meat Recovery (an automated system for cutting meat from bones), may be used since USDA regulations do not allow the presence of SRMs in this product.
The second interim final rule is designed to lower even further the risk that cattle will be purposefully or inadvertently fed prohibited protein. It was the feeding of such protein to cattle that was the route of disease transmission that led to the BSE epidemic in United Kingdomcattle in the 1980's and 1990's.

This interim final rule will implement four specific changes in FDA's present animal feed rule. The rule:

Will eliminate the present exemption in the feed rule that allows mammalian blood and blood products to be fed to other ruminants as a protein source. Recent scientific evidence suggests that blood can carry some infectivity for BSE.
Will also ban the use of "poultry litter" as a feed ingredient for ruminant animals. Poultry litter consists of bedding, spilled feed, feathers, and fecal matter that are collected from living quarters where poultry is raised. This material is then used in cattle feed in some areas of the country where cattle and large poultry raising operations are located near each other. Poultry feed may legally contain protein that is prohibited in ruminant feed, such as bovine meat and bone meal. The concern is that spillage of poultry feed in the chicken house occurs and that poultry feed (which may contain protein prohibited in ruminant feed) is then collected as part of the "poultry litter" and added to ruminant feed.
Will ban the use of "plate waste" as a feed ingredient for ruminants. Plate waste consists of uneaten meat and other meat scraps that are currently collected from some large restaurant operations and rendered into meat and bone meal for animal feed. The use of "plate waste" confounds FDA's ability to analyze ruminant feeds for the presence of prohibited proteins, compromising the Agency's ability to fully enforce the animal feed rule.
Will further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could lead to cross-contamination.
To accompany these new measures designed to provide a further layer of protection against BSE, FDA plans to step up its inspections of feed mills and renderers. FDA will itself conduct 2,800 inspections and will make its resources go even further by continuing to work with state agencies to fund 3,100 contract inspections of feed mill and renderers and other firms that handle animal feed and feed ingredients. Through partnerships with states, FDA will also receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections in 2004 alone, including annual inspections of 100 percent of all known renderers and feed mills that process products containing materials prohibited in ruminant feed.

UPDATE: The FDA also notes that in response to finding a BSE positive cow in Washington state on December 23, it inspected and traced products at 22 facilities related to that positive cow or products from the cow, including feed mills, farms, dairy farms, calf feeder lots, slaughter houses, meat processors, transfer stations, and shipping terminals. Moreover, FDA conducted inspections at the rendering facilities that handled materials from the positive cow, and they were found to be fully in compliance with FDA's feed rule.

To further strengthen protections for Americans, FDA/HHS intends to work with Congress to consider proposals to assure that these important protective measures will be implemented as effectively as possible.

FDA is also continuing its efforts to assist in the development of better BSE science, to achieve the same or greater confidence in BSE protection at a lower cost. For example, to enhance the ability of the USpublic health system to detect prohibited materials in animal feed, FDA will continue to support the development and evaluation of diagnostic tests to identify prohibited materials. These tests would offer a quick and reliable method of testing animal feeds for prohibited materials and for testing other products for contamination with the agent thought to cause BSE.

Warning Letters Issued for Violations of BSE Regulations

On May 6, 2003, the FDA’s Minneapolis District Office issued a Warning Letter to the President of Barr Animal Foods, Greenwood, Wisconsin. The FDA conducted an inspection of the firm on April 8, 2003. The inspection disclosed that the firm was not labeling their 50 pound blocks of frozen beef and bulk loads of beef bone chips and rendering waste, intended for animal feed with the required cautionary statement.

On August 25, 2003, the FDA’s Chicago District Office issued a Warning Letter to the president of Lincoln Land Livestock Co., Inc., Mascoutah, Illinois. On April 14 - 15, 2003, FDA conducted inspection of the animal feed handling facility. The investigator found that products that contained or may contain prohibited material failed to bear the caution statement, “Do not feed to cattle or other ruminants.” The inspection also disclosed that the firm did not maintain written clean-out procedures to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants.

On November 7, 2002, the FDA’s Dallas District Office issued a Warning Letter to the President and Manager of Sunnymead Ranch, Inc., Idalou, Texas. An FDA inspection of this feed mill found significant deviations from 21 CFR 589.2000. FDA’s inspection revealed that the firm manufactures feed for sheep, that may contain residues of prohibited material. The sheep feed is mixed in the same equipment that is used for mixing chicken feed containing bovine meat and bone meal. In addition, the firm failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissue to animal protein or feeds that may be used for ruminants. The Warning Letter cautioned, “As a feed manufacturer and ruminant feeder of sheep intended for slaughter as food, you are responsible for ensuring that your operations are in full compliance with the law.”

On May 22, 2003, the FDA’s New Orleans District Office issued a Warning Letter to the Manager and Owner of Millstone Agri Distributors, Maryville, Tennessee. An FDA inspection of the firm on February 13, 2003, found significant deviations from the requirements of Title 21, Code of Federal Regulations (21 CFR), Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed.

FDA’s investigation found the following violations of 21 CFR 589.2000:

Failure to separate the receipt, processing, and storage of products containing prohibited material from products not containing prohibited material;
Failure to establish written procedures, including clean-out and flushing procedures, to avoid commingling and cross-contamination of common equipment;
Failure to maintain records sufficient to track prohibited materials throughout the receipt, processing, and distribution of products;
Failure to provide for measures to avoid commingling or cross-contamination of feeds intended for ruminants and feeds intended for non-ruminants that may contain prohibited materials;
Failure to label non-ruminant products with the required cautionary statement “Do not Feed to Cattle or Other Ruminants.” The investigation specifically found that dog food containing prohibited material was added as an ingredient to the product “Premium Rooster Kicker.” The failure of these feeds to bear the required BSE warning statement causes them to be misbranded.
Consent Decree of Permanent Injunction Against X-Cel Feeds, Inc. Feed Manufacturer Enjoined for Violations of the 1997 Animal Feed Rule

On July 11, 2003, FDA announced the filing of a Consent Decree of Permanent Injunction against X-Cel, Feeds Inc., and individual officers based on violations of the Federal Food, Drug, and Cosmetic Act.


X-Cel, a feed manufacturer headquartered in Tacoma, Washington, failed to comply with FDA regulations (the 1997 Animal Feed Rule) designed to prevent the establishment and spread of Bovine Spongiform Encephalopathy (BSE, also known as "Mad Cow Disease") should it ever be found in the United States and FDA regulations concerning the manufacture of medicated feeds.


The Department of Justice, Civil Division, Office of Consumer Litigation and the United States Attorney's Office of the Western District of Washington filed the Consent Decree in the United States District Court of the Western District in Tacoma, Washington. It permanently enjoins X-Cel from manufacturing animal feeds in violation of the Federal Food, Drug, and Cosmetic Act and requires the firm, its officers, and employees to take specific steps to avoid future violations including, implementing clean-out procedures, obtaining protein supplier certifications and implementing standard operating procedures for compliance until it satisfies FDA that it has corrected its problems. ...


http://www.fda.gov/ora/about/enf_story/archive/2003/ch5/cvm1.htm

CVM Update
September 30, 2003

Update On Ruminant Feed (BSE) Enforcement Activities


http://www.fda.gov/cvm/CVM_Updates/BSEInspec03.htm

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
Consolidated Nutrition 32 % Floating Catfish Food, packaged in 50-lb bags. Recall # V-100-3.
CODE
Best By MAR 25 04; and Best By APR 16 04, The codes are ink-jetted on the bags.
RECALLING FIRM/MANUFACTURER
Doane Pet Care Company, Inc., Washington Courthouse, OH, by telephone and letter on April 16, 2003 and April 17, 2003. FDA initiated recall is ongoing.
REASON
The fish feed product lacks the required BSE warning statement, and the nutritional ingredient statement on the label.
VOLUME OF PRODUCT IN COMMERCE
210/50 lb bags.
DISTRIBUTION
OH, PA, and MI.


http://www.fda.gov/bbs/topics/enforce/2003/ENF00796.html

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE--CLASS II
_____________________________
PRODUCT
Red Rooster Booster, Super Gallo (brand), 60 capsules. Recall # V-011-3.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Thomas Laboratories, Tolleson, AZ, by letters on or about November 8, 2002. State initiated recall is ongoing.
REASON
Is not labeled "Do not feed to cattle or other ruminants" and contains a bovine tissue derivative.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide.

_____________________________
PRODUCT
CATTLE FEED, Flock #999, Date: 12/5/02, Quantity 8000, Load A, Feed C205, Grower# Z001, Tag C100. Recall # V-012-3.
CODE
C-205, C-210, C-220, C-302, C-406 and all other codes manufactured and distributed by Grove River Mills, Inc.,
RECALLING FIRM/MANUFACTURER
Grove River Mills Inc., Pendergrass, GA, by telephone and letter on December 9, 2002. Firm initiated recall is ongoing.
REASON
Cattle Feed contaminated with prohibited materials.
VOLUME OF PRODUCT IN COMMERCE
235,668 lbs.
DISTRIBUTION
GA.

END OF ENFORCEMENT REPORT FOR FEBRUARY 5, 2003

###

http://www.fda.gov/bbs/topics/enforce/2003/ENF00781.html

PRODUCT
Unlabeled bulk "Cattle Feed" sold by weight to user/farmers who pick it up at the firm. Product is a ruminant feed used to feed beef cattle. Recall # V-046-3.
CODE
Product is bulk and uncoded.
RECALLING FIRM/MANUFACTURER
Zephyr Feed Company, Zephyrhills, FL., by letters on March 19, 2003 and March 26, 2003. FDA initiated recall is ongoing.
REASON
Cattle feed was distributed to farmers that may contain prohibited protein for ruminants.
VOLUME OF PRODUCT IN COMMERCE
517,990 lbs.
DISTRIBUTION
FL.

END OF ENFORCEMENT REPORT FOR APRIL 23, 2003

###

http://www.fda.gov/bbs/topics/enforce/2003/ENF00792.html

_______________________________
PRODUCT
Steamed bone meal under the following labels:
1) Upco Steamed Bone Meal for Dogs, Cats, and Horses, packaged in 1-lb. laminated pouches. 2) Benepet Steamed Bone Meal for Dogs, Cats, and Horses, packaged in a 1-lb. plastic jar. Recall # V-295-3.
CODE
Upco brand: 010584, 012214, 012431,020672, 021124, 021834, 030616, 030901, 031293, 031301, 031401, 031981, 032382, 032626, 033136, 040171, 041316, 051635, 051991, 052320, 060505, 061115, 061783, 071006, 072328, 080212, 080826, 081621, 082217, 082274, 082683, 083095, 092381, 101613, 102772, 111087, 111201, 111694, 112112.
Benepet brand: 011004, 012435, 021191, 021374, 022111, 032203, 032821, 041432, 042611, 051181, 051992, 060371, 061129, 061203, 080816, 081185, 082802, 090422, 092295, 111202, 120572, 120612.
RECALLING FIRM/MANUFACTURER
Ameri-Pac, Inc., St. Joseph, MO, via telephone on June 27, 2003 and by letter dated July 24, 2003. FDA initiated recall is complete.
REASON
Label lacks the cautionary statement "Do Not Feed to Cattle or Other Ruminants."
VOLUME OF PRODUCT IN COMMERCE
23.3 tons Upco brand and 6.7 tons Benepet brand.
DISTRIBUTION
MO.

http://www.fda.gov/bbs/topics/enforce/2003/ENF00816.html

RECALLING FIRM/MANUFACTURER
Liver Powder, Super Gallo (brand), 16 oz. bag. Recall # V-005-4.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Thomas Veterinary Drug, Tolleson, AZ, by letter, on September 20, 2002. Kentucky State initiated recall is complete.
REASON
Product is not labeled "Do not feed to cattle or other ruminants".
VOLUME OF PRODUCT IN COMMERCE
320.
DISTRIBUTION
AR, NC, WV, KY, LA, TN, HI, CA and AL.

http://www.fda.gov/bbs/topics/enforce/2003/ENF00828.html


2004


SELECTED FY 2004 ACCOMPLISHMENTS

USING RISK-BASED MANAGEMENT PRACTICES

Bovine Spongiform Encephalopathy (BSE)

• For fiscal year 2004, inspected over 6,806 renderers, feed mills, and other firms,

including on-farm mixers and ruminant feeders, to determine compliance with the

BSE feed regulations. At the end of the FY 2004, 17 firms were classified as being

out of compliance at the time of their last inspection. Re-inspections of these

facilities determined to be out of compliance with the BSE regulation are still ongoing;

• FDA and state investigators specifically inspected a high-interest subset of 645 firms

as part of our annual BSE performance goal feed inspections obligation. This subset

represented 100 percent of all known renderers and feed mills processing products

containing prohibited material;

• In July 2004, co-published with USDA an advanced notice of proposed rulemaking

(ANPRM) requesting comments and scientific information on several additional

regulatory measures that would strengthen the feed regulation;

230

• Developed a real-time Polymerase Chain Reaction (PCR) based method capable of

detecting cattle, swine, sheep, goats, horses, or deer material along with poultry,

goose, and turkey for use in analyzing samples of animal feeds and feed ingredients

in support of the animal protein prohibition;

• Evaluated two commercially available diagnostic test marketed to detect mammalian

proteins in animal feed and feed ingredients;

• Issued 10 Warning Letters for animal proteins prohibited in ruminant feed, and 15

class II recalls involving 15 firms and 25 products in response to violations of the

BSE rule;

snip...full text ;


http://www.fda.gov/oc/oms/ofm/budget/2006/PDFs/Summary/Pages226thru251.pdf

Completed 50 feed recall events. Thirty-tree of the 50 recall events were feed related. Fifteen of the 33 recalls were related to BSE feed regulation;


http://www.fda.gov/cvm/CVMAccomp.htm

CVM Update
November 23, 2004

November 2004 Update on Ruminant Feed (BSE) Enforcement Activities


http://www.fda.gov/cvm/CVM_Updates/bseup112304.htm

CVM Update
July 29, 2004

July 2004 Update on Ruminant Feed (BSE) Enforcement Activities


http://www.fda.gov/cvm/CVM_Updates/bse72004up.htm


FDA Strategic Goal: Improving Product Quality, Safety, and Availability through Better Manufacturing and Product Oversight
Bovine Spongiform Encephalopathy (BSE)
FDA animal feed experts joined the USDA team to provide technical expertise in an audit conducted by the Canadian Food Inspection Agency in response to the detection of two cases of BSE in Canada in 2004. Records were reviewed, meetings were held and facilities across Canada were inspected. USDA issued a report of its findings on February 25, 2005.
Issued 10 Warning Letters for animal proteins prohibited in ruminant feed, and 15 class II recalls involving 15 firms and 25 products in response to violations of the BSE rule.
Provided BSE inspection training to FDA investigators as well as state inspectors during the fiscal year.
Provided personnel and expertise on BSE and animal feed issues to the U.S. Department of Agriculture in support of its efforts to reopen foreign markets for U.S. beef.
Continued the development of a real-time Polymerase Chain Reaction (PCR) based method capable of detecting cattle, swine, sheep, goats, horses, or deer material along with poultry, goose, and turkey for use in analyzing samples of animal feeds and feed ingredients in support of the animal protein prohibition. "Real-time" means that we can detect the presence of prohibited material as the reaction is taking place, so we do not have to further process the sample.
Completed the evaluation of a third commercially available diagnostic test marketed for the detection of ruminant proteins in animal feed. Like the other diagnostic tests previously evaluated, this test was much less sensitive than the methods the Agency uses (microscopy and PCR) for analysis of animal feed.
FDA implemented an advanced analytical procedure for detection of prohibited material in animal feed into an assignment issued for 900 domestic and 900 import feed samples. This novel approach combines light microscopy with polymerase chain reaction (PCR) to determine and detect DNA from ruminants and non-ruminant mammalian species, supporting the BSE/Ruminant Feed Ban. (Field Activity)
Following the finding of a BSE positive animal in Texas, FDA, USDA/APHIS, the Texas Animal Health Commission, and the Texas Feed and Fertilizer Control Service successfully conducted a feed investigation with two main objectives. The first objective was to identify all protein sources in the animal's feed history that could potentially have been the source of the BSE agent. The second objective was to verify that cattle leaving the herd after 1997 that were identified by USDA/APHIS as animals of concern, such as progeny and feed cohorts, were rendered at facilities in compliance with the BSE/ruminant feed ban regulation. (Field Activity)
Awarded contracts with state and local governments to perform BSE, feed manufacturers and illegal tissue residue inspections. Auditor training was conducted for feed contracts. (Field Activity)
Reviewed and awarded Cooperative Agreement grants for BSE infrastructure improvement in eight states. The Agency and the States maintained and continued to develop new partnerships (e.g., BSE inspections) that have contributed to the exchange of inspection and sampling data and have facilitated the receipt of training and distribution of equipment to the states. (Field Activity)
snip... full text ;

http://www.fda.gov/oc/oms/ofm/budget/2007/HTML/4AnimalDrugs.htm

CVM Update

July 9, 2004

FDA and USDA Request Comments and Scientific Information on Possible New BSE Safeguards


Today, the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) announced that they will publish an advance notice of proposed rulemaking ( ANPRM ) -- that requests comments and scientific information on several additional measures related to animal feed under consideration to help prevent the spread of bovine spongiform encephalopathy (BSE, also known as “Mad Cow Disease”) in the United States. Some of these measures include:

removing specified risk materials (SRMs) from all animal feed, including pet food, in order to control the risks of cross contamination throughout feed manufacture and distribution and on the farm due to misfeeding;

requiring dedicated equipment or facilities for handling and storing feed and ingredients during manufacturing and transportation, to prevent cross contamination;

prohibiting the use of all mammalian and poultry protein in ruminant feed, to prevent cross contamination; and

prohibiting materials from non-ambulatory disabled cattle and dead stock from use in all animal feed.

FDA has tentatively concluded that it should propose to remove SRMs from all animal feed and is currently working on a proposal to accomplish this goal. Comments on the issues raised by FDA in the ANPRM are due to FDA 30 days after they publish in the Federal Register.

FDA’s 1997 ruminant feed rule has been a critical safeguard to stop the spread of BSE through the U.S. cattle population by prohibiting the feeding of most mammalian protein to cattle and other ruminant animals.

After a BSE-positive cow was detected in late December 2003, FDA announced its plans to publish interim final rules on BSE that would take effect immediately upon publication. For animal feed, FDA stated that the rule would eliminate the present exemption in the ruminant feed rule that allows mammalian blood and blood products to be fed to other ruminants as a protein source, ban the use of "poultry litter" as a feed ingredient for ruminant animals, and ban the use of "plate waste" as a feed ingredient for ruminants. In addition, FDA said that to further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed, the rule would require equipment, facilities, or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed.

On February 4, 2004 , shortly after FDA announced its plans to publish interim final rules on BSE, an International Review Team (IRT) convened by USDA issued a report and additional actions to protect the public against BSE.

The proposed actions were significantly different from those FDA announced in late January. Some of those proposals would make some of FDA’s actions unnecessary. Rather than publishing a regulation that would take effect automatically, USDA and FDA are soliciting public comment on the IRT’s suggestions, as well as other measures designed to protect North America against BSE. By seeking comment on the IRT’s recommendations, the agencies hope to put into effect the most comprehensive, science-based improvements possible.

http://www.fda.gov/cvm/CVM_Updates/bseanprm.htm

CVM Update
April 22, 2004

April 2004 Update on Ruminant Feed (BSE) Enforcement Activities

http://www.fda.gov/cvm/CVM_Updates/bse42004.htm

CVM Update
February 6, 2004

Update on Ruminant Feed (BSE) Enforcement Activities

http://www.fda.gov/cvm/CVM_Updates/BSE0206up.htm

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE-CLASS II
_______________________________
PRODUCT
Grand Vite, Nutritional Supplement, in tubs. 5, 10 and 25 pounds. Designed for horses only. Recall # V-006-4.
CODE
Lot 1473.
RECALLING FIRM/MANUFACTURER
Grand Meadows, Inc., Orange, CA, by facsimile, on September 3, and September 5, 2003. FDA initiated recall is complete.
REASON
Product contains prohibited animal protein and is not labeled to prevent feeding to ruminants.
VOLUME OF PRODUCT IN COMMERCE
131 packages of 5, 10 and 25 pounds.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Halter 15% Pig Meal, in 50 pound paper bags.
Recall # V-008-4;
b) Halter 18% Layer Pellet, in 50 pound paper bags.
Recall # V-009-4.
CODE
No codes.
RECALLING FIRM/MANUFACTURER
Halter Feed & Grain Inc., Massillon, OH, by telephone and letter on December 3, 8, and 10, 2003. FDA initiated recall is ongoing.
REASON
Animal feed that contains protein derived from mammalian tissue was not labeled with the required BSE caution statement, "Do not feed to cattle and other ruminants".
VOLUME OF PRODUCT IN COMMERCE
80 bags (4 tons).
DISTRIBUTION
OH.

END OF ENFORCEMENT REPORT FOR January 14, 2004

###


--------------------------------------------------------------------------------

http://www.fda.gov/bbs/topics/enforce/2004/ENF00830.html

PRODUCT
ZuPreem Feline Diet, 14.0 oz cans for Non-Domesticated
Carnivores in the families Fedlidae, Canidea, and Hyenadea.
Recall # V-115-4.
CODE
6910 S1 SF01 military time of production: 06:05.
RECALLING FIRM/MANUFACTURER
Menu Foods, Inc., Pennsauken, NJ, by telephone on February 2, 2004. FDA initiated recall is complete.
REASON
LACF Feiline Diet for non-domestic carnivores does not carry the BSE warning statement.
VOLUME OF PRODUCT IN COMMERCE
1,620 cases.
DISTRIBUTION
KS.

_______________________________
PRODUCT
Product is a horse supplement packed into a 5 lb. Plastic
container with a yellow/green/red/brown label printed in
part "FORMULA: Each 5 pounds contains: Chondroitin Sulfate
27,000 mg D-Glucosamine HCL 100,000 mg Collagen hydrolyzed
27,000 MSM (methysulfonylmethane) 2,500 mg. Carti-Flex
COMPLEX net wt. 5 lbs, a concentrated natural joint
supplement containing Glucosamine HCL, Chondroitin sulfate,
Hydrolixed collagen and MSM". Recall # V-116-4.
CODE
All codes without the required cautionary statement are under recall.
RECALLING FIRM/MANUFACTURER
Interfarma Corporation, Miami, FL, by letters on February 4, 2004. FDA initiated recall is ongoing.
REASON
This animal feed product does not contain the required BSE cautionary statement: "Do Not Feed to Cattle or Other Ruminants".
VOLUME OF PRODUCT IN COMMERCE
80 cases 4-5 lb. Containers per case.
DISTRIBUTION
Venezuela, Nicaragua and Guatemala.

END OF ENFORCEMENT REPORT FOR MARCH 24, 2004

###


http://www.fda.gov/bbs/topics/enforce/2004/ENF00840.html

PRODUCT
Custom deer feed made for a Wisconsin farm. The product was in bags holding about 40 pounds each. Recall # V-122-4.
CODE
1-30-04 on the product invoice and mixing record.
RECALLING FIRM/MANUFACTURER
Crivitz Feed Mill, Crivitz, WI, by telephone on February 20, 2004. Wisconsin State initiated recall is complete.
REASON
The recalled deer feed contained steamed bone meal which is prohibited material in feed for ruminants.
VOLUME OF PRODUCT IN COMMERCE
515 pounds.
DISTRIBUTION
WI.

>

END OF ENFORCEMENT REPORT FOR APRIL 7, 2004

###


http://www.fda.gov/bbs/topics/enforce/2004/ENF00842.html


PRODUCT
Custom dairy cattle feed made for two customers. Recall # V-123-4.
CODE
None.
RECALLING FIRM/MANUFACTURER
Maribel Grain Co., Maribel, WI, by visit on February 25, 2004. Firm initiated recall is complete.
REASON
Possible cross contamination of cattle feed by steamed bone meal which is prohibited material.
VOLUME OF PRODUCT IN COMMERCE
2,040 pounds.
DISTRIBUTION
WI.
______________________________


PRODUCT
B & G Seed Co., PIG GROWER, 50 lbs. Recall # V-126-4.
CODE
All.
RECALLING FIRM/MANUFACTURER
B & G Seed Company, Inc., Hull, GA, by telephone on March 30, 2004. Firm initiated recall is ongoing.
REASON
Feed contains meat & bone meal (prohibited material), without the mandatory ruminant warning on the label.
VOLUME OF PRODUCT IN COMMERCE
25/50 lb. bags.
DISTRIBUTION
GA.


http://www.fda.gov/bbs/topics/enforce/2004/ENF00843.html

_______________________________
PRODUCT
Cloverbelt 38% (38% protein concentrate for use in animal feed) in bulk. Recall # V-127-4.
CODE
The recall product is a bulk feed commingled in a bin prior to sale - no lot number.
RECALLING FIRM/MANUFACTURER
Cloverbelt Lumber & Feed Co., Conrath, WI, by telephone on February 23, 2004. Firm initiated recall is complete.
REASON
Possible cross contamination of the 38% protein concentrate with prohibited material (bone meal).
VOLUME OF PRODUCT IN COMMERCE
18 tons.
DISTRIBUTION
WI.

END OF ENFORCEMENT REPORT FOR APRIL 28, 2004

###


http://www.fda.gov/bbs/topics/enforce/2004/ENF00845.html


PRODUCT
a) Bulk whole corn. Recall # V-150-4;
b) Bulk rolled corn. Recall # V-151-4;
c) Bulk rolled corn with added fat. Recall # V-152-4.
CODE
No coding information is used.
RECALLING FIRM/MANUFACTURER
Fresno Farming LlC, Traver, CA, by letters on June 30, 2004. Firm initiated recall is ongoing.
REASON
Corm for feed may be contaminated with ruminant meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Unknown.
____________________________


http://www.fda.gov/bbs/topics/enforce/2004/ENF00857.html

_______________________________
PRODUCT
a) Product is 9 Mile Steer Feed, packaged in white poly weaved
bags, each containing 100 lbs. A white label tied to the
inlet of each bag with twine identifies the product. Recall
# V-187-4;
b) Product is 9 Mile Pig and Sow Feed, packaged in white poly
weaved bags, each bag containing 100 lbs. A white label tied
to the inlet of each bag with twine identifies the product.
Recall # V-188-4.
CODE
The products contain no code date.
RECALLING FIRM/MANUFACTURER
Farmers Elevator, Co., Houston, OH, by telephone and letters dated September 8, 2004. Firm initiated recall is ongoing.
REASON
Products may contain protein derived from mammalian tissues which is prohibited in ruminant (steer) feed. FDA regulation, if the feed is intended for non-ruminants (pigs), the bag labels must bear the statement ìDo not feed to cattle or other ruminantsî.
VOLUME OF PRODUCT IN COMMERCE
700 lbs. Steer feed and 1,500 lb. Pig and sow fed.
DISTRIBUTION
OH.

PRODUCT
a) Premier Catfish Food, packaged in 50 pound bags (white paper
with an orange label). Recall #V-190-4;
b) Happy Fisherman Fish Food, pellet form, 50 pound bags.
Recall # V-191-4.
CODE
a) T1 Best By 08/27/05;
b) T21 Best By 11 DEC 05 and T11 Best By 02 OCT 05.
RECALLING FIRM/MANUFACTURER
Sunshine Mills, Inc., Tupelo, MS, by telephone beginning on April 14, 2004. Firm initiated recall is complete.
REASON
The catfish food contains prohibited material (meat & bone meal) but does not contain the cautionary statement, "Do not feed to cattle or other ruminants" on the label.
VOLUME OF PRODUCT IN COMMERCE
1,092 ‚ 50 pound bags.
DISTRIBUTION
TX and MO.

http://www.fda.gov/bbs/topics/enforce/2004/ENF00869.html

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
_______________________________
PRODUCT
Product is custom made steer/cattle feed packaged in 100 lb. poly bags. The product has no labeling. Recall # V-001-5.
CODE
The product has no lot code. All custom made feed purchased between June 24, 2004 and September 8, 2004.
RECALLING FIRM/MANUFACTURER
Farmers Elevator Co, Houston, OH, by telephone and letter dated September 27, 2004. Firm initiated recall is ongoing.
REASON
Feed may contain protein derived from mammalian tissues which is prohibited in ruminant feed.
VOLUME OF PRODUCT IN COMMERCE
Approximately 80 1û2 tons of steer/cattle feed.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Product is custom made sheep/goat feed packaged in 100 lb. poly bags. The product has no labeling. Recall # V-002-5.
CODE
The product has no lot code. All custom made feed purchased between June 24, 2004 and September 8, 2004.
RECALLING FIRM/MANUFACTURER
Farmers Elevator Co, Houston, OH, by telephone and letter dated September 27, 2004. Firm initiated recall is ongoing.
REASON
Feed may contain protein derived from mammalian tissues which is prohibited in ruminant feed.
VOLUME OF PRODUCT IN COMMERCE
Approximately 8 tons.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Product is custom made deer feed packaged in 100 lb. poly bags. The product has no labeling. Recall # V-003-5.
CODE
The product has no lot code. All custom made feed purchased between June 24, 2004 and September 8, 2004.
RECALLING FIRM/MANUFACTURER
Farmers Elevator Co, Houston, OH, by telephone and letter dated September 27, 2004. Firm initiated recall is ongoing.
REASON
Feed may contain protein derived from mammalian tissues which is prohibited in ruminant feed.
VOLUME OF PRODUCT IN COMMERCE
Approximately 6 tons.
DISTRIBUTION
OH.

END OF ENFORCEMENT REPORT FOR October 20, 2004

###

http://www.fda.gov/bbs/topics/enforce/2004/ENF00870.html

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_______________________________
PRODUCT
a) Hi-Tek Rations Horse Nuggets***Performance***
Net Wt. 40 lb (18.14 kg). Recall # V-006-5;
b) Hi-Tek Rations***Aqua-Tek***Quality Floating
Fish Food***Net Wt. 50 Lbs (22.68kg). Product
is packed in paper bags in amounts specified.
Recall # V-007-5.
CODE
a) Lot # 073128;
b) Lot #071202.
RECALLING FIRM/MANUFACTURER
HI-TEK Rations, Inc., Dublin, GA, by letter on September
17, 2004. Firm initiated recall is ongoing.
REASON
Product may contain prohibited ruminants; however, label does not have required caution statement.
VOLUME OF PRODUCT IN COMMERCE
10 tons.
DISTRIBUTION
AL, GA, NC, SC, WV.


http://www.fda.gov/bbs/topics/enforce/2004/ENF00880.html


2005

VM Update
December 5, 2005

November 2005 Update on Feed Enforcement Activities to Limit the Spread of BSE

http://www.fda.gov/cvm/CVM_Updates/BSE1105.htm

CVM Update
June 20, 2005

June 2005 Update on Feed Enforcement Activities to Limit the Spread of BSE

http://www.fda.gov/cvm/CVM_Updates/bse0605.htm

CVM Update
March 17, 2005

March 2005 Update on Feed Enforcement Activities to Limit the Spread of BSE

http://www.fda.gov/cvm/CVM_Updates/BSE0305.htm

PRODUCT
a) Bulk nonmedicated custom swine and poultry feeds,
Recall # V-006-6;
b) Bulk medicated swine and poultry feeds, Recall # V-007-6
CODE
N/A
RECALLING FIRM/MANUFACTURER
Gold Eagle Cooperative, Goldfield, IA, by telephone or visit beginning August 30, 2005. Firm initiated recall is complete.
REASON
Swine and poultry feeds which may contain prohibited material are not labeled with the warning statement not to feed to cattle or other ruminants.
VOLUME OF PRODUCT IN COMMERCE
Approx. 15,323.68 tons of nonmedicated and medicated feed
DISTRIBUTION
IA, GA, MD, and MN


http://www.fda.gov/bbs/topics/enforce/2005/ENF00925.html

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
Hydrolyzed Feather Meal, 50 lb. bags, Recall # V-109-5
CODE
Lot number: 11579
RECALLING FIRM/MANUFACTURER
Recalling Firm: Griffin Industries, Inc., Cold Springs, KY, by telephone on September 2, 2005.
Manufacturer: Griffin Industries, Inc., Henderson, KY. Firm initiated recall is ongoing.
REASON
Product may contain prohibited material and is not identified with the cautionary statement: "Do not feed to cattle or other ruminants".
VOLUME OF PRODUCT IN COMMERCE
863/50 lb. bags
DISTRIBUTION
IN

END OF ENFORCEMENT REPORT FOR SEPTEMBER 28, 2005

###


http://www.fda.gov/bbs/topics/enforce/2005/ENF00919.html

2006

CVM Update
May 9, 2006

April 2006 Update on Feed Enforcement Activities to Limit the Spread of BSE

http://www.fda.gov/cvm/CVM_Updates/BSE0506.htm


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


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 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


WE know now, and we knew decades ago, that 5.5 grams of suspect feed in TEXAS was enough to kill 100 cows.


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


2

6. It also appears to me that Mr Bradley’s answer (that it would take less than say 100

grams) was probably given with the benefit of hindsight; particularly if one

considers that later in the same answer Mr Bradley expresses his surprise that it

could take as little of 1 gram of brain to cause BSE by the oral route within the

same species. This information did not become available until the "attack rate"

experiment had been completed in 1995/96. This was a titration experiment

designed to ascertain the infective dose. A range of dosages was used to ensure

that the actual result was within both a lower and an upper limit within the study

and the designing scientists would not have expected all the dose levels to trigger

infection. The dose ranges chosen by the most informed scientists at that time

ranged from 1 gram to three times one hundred grams. It is clear that the designing

scientists must have also 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/s147f.pdf


Re: BSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts

[BBC radio 4 FARM news]


http://www.maddeer.org/audio/BBC4farmingtoday2_1_03.ram


http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm


2) Infectious dose:

To cattle: 1 gram of infected brain material (by oral ingestion)


http://www.inspection.gc.ca/english/sci/bio/bseesbe.shtml


Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518


[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle

03-025IFA
03-025IFA-2
Terry S. Singeltary


Page 1 of 17

From: Terry S. Singeltary Sr. [flounder9@verizon.net]

Sent: Thursday, September 08, 2005 6:17 PM

To: fsis.regulationscomments@fsis.usda.gov

Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements

for the Disposition of Non-Ambulatory Disabled Cattle

Greetings FSIS,

I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and

Requirements for the Disposition of Non-Ambulatory Disabled Cattle

THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle

Broken bones and such may be the first signs of a sub clinical BSE/TSE Non-Ambulatory Disabled Cattle ;

SUB CLINICAL PRION INFECTION

MRC-43-00

Issued: Monday, 28 August 2000

NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCH

FINDINGS RELEVANT TO CJD AND BSE


Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518

9/13/2005

http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf


Board Number: I-12
Title: Risk Factors for Animal Drug and Feed Products, Manufacturing Processes and Facilities: Analysis of Recalls, 2000 – 2005

V. Wiles , E. A. Grove , K. B. Ekelman , CVM, FDA, Rockville, MD

Background: The Center for Veterinary Medicine (CVM) is developing a risk-based inspection system to help ensure that regulatory resources are focused on the animal feed and drug products, manufacturing processes and facilities that pose the greatest risks to animal and human health. To help identify risk factors for animal feed and drug products, manufacturing processes and facilities, we analyzed 203 firm-initiated recalls of animal drug and feed products from fiscal years 2000 through 2005. A recall is a firm\'s removal or correction of a marketed product that FDA considers to be in violation of the laws it administers.


Methods: We reviewed records for 203 firm-initiated recalls of animal drug and feed products from fiscal years 2000 to 2005 to identify the types of errors associated with recalled animal drug and feed products and to determine which recalled products and errors were associated with the highest levels of health hazards. The relative level of health hazard attributed to each recalled product by FDA is reflected in an assigned recall classification number (i.e., I, II, or III).


Results: Of the 203 firm-initiated recalls of animal drug and feed products from fiscal years 2000 through 2005, 103 (approximately 51%) were for non-medicated feeds, 33 (approximately 16%) were for medicated feeds, and 64 (approximately 32%) were for animal drugs. For recalls of non-medicated feeds, 18% were classified as posing a high level of health hazard (recall classification I) and 76% were classified as posing a moderate health hazard (recall classification II). For recalls of medicated feeds, 13% were classified as posing a high level of health hazard and 53% were classified as posing a moderate level of health hazard. For recalls of animal drugs, 5% were classified as posing a high level of health hazard and 42% were classified as posing a moderate level of health hazard. The most common errors identified for recalls of non-medicated feeds were those related to the BSE rule. The most common errors identified for recalls of medicated feeds were incorrect levels of drugs in feeds or feeding medicated feeds to species or ages for which the drugs in the feeds were not approved. Other errors associated with recalls of non-medicated and medicated feeds included chemical or microbiological contamination, labeling errors, and general manufacturing errors. The most common errors associated with recalls of animal drugs were due to concerns about the drugs’ stability, sterility and labeling.


Conclusions: CVM is using information from the analysis of the animal feed and drug products associated with 203 firm-initiated recalls from fiscal years 2000 through 2005 to help rank the relative risks from the products, manufacturing processes and facilities.


Category: I. Risk Management, Risk Assessment,and Risk Communication for Medical Products and Foods

http://www.accessdata.fda.gov/scripts/oc/scienceforum/sf2006/search/preview.cfm?abstract_id=838&backto=category


BAB = BORN AFTER BAN

BARB = BORN AFTER RUMINANT BAN

MAMB = BORN AFTER MAMMALIAN BAN

http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/200503canada/fig3desce.html

Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518

CJD WATCH

----- Original Message -----
From: Terry S. Singeltary Sr.
To: fdadockets@oc.fda.gov
Sent: Thursday, August 03, 2006 3:53 PM
Subject: Docket: 2003N-0312 - Animal Feed Safety System: A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds; Request for Comments


Docket: 2003N-0312 - Animal Feed Safety System: A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds; Request for Comments
Temporary Comment Number: 88329


FDA Animal Feed Safety System (AFSS) Public Meeting
Center for Veterinary Medicine
Meeting Room A, 3rd Floor
7519 Standish Place, Rockville, MD 20855
Tuesday, September 12, 2006
9 a.m. to 4:30 p.m.


The Food and Drug Administration (FDA) is holding a public meeting to present work-in-progress on a method for ranking animal feed contaminants by their relative risks to animal and human health. At this meeting, the Agency will describe the methods it plans to use to develop animal and human Health Consequence Scoring for chemical, physical and biological feed contaminants.

The meeting will be held Tuesday, September 12, 2006, in Meeting Room A third floor, at 7519 Standish Place, Rockville, MD 20855. For additional information, please contact Zoe Gill, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6867, Fax 240-453-6882 or email: zoe.gill@fda.hhs.gov.

Prior to the public meeting, the FDA will place two documents in Docket No. 2003N-0312 entitled, “List of Potentially Hazardous Contaminants in Animal Feed and Feed Ingredients” and “Determining Health Consequence Scoring for Feed Contaminants.” The documents will summarize the Agency’s methods for assigning animal and human Health Consequence Scoring to physical, chemical and biological contaminants that may be present in animal feed. Details of these methods will be discussed at the meeting. An agenda for the meeting will also be placed in docket.

You may submit written comments to the Division of Dockets Management (HFA 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Two copies of written comments are to be submitted, except that individuals may submit one copy. Information on how to submit written or electronic comments can be found at http://www.accessdata.fda.gov/scripts/oc/dockets/comments/FAQ.cfm?AGENCY=FDA#_Toc62455540.

Due to limited meeting space, registration will be required. We strongly encourage early registration. Registration is by telephone, fax or e-mail. Please use the registration form to provide registration information (including name, title, firm name, address, telephone, and fax number) to Nanette Milton, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6840, Fax 240-453-6880 or email: nanette.milton@fda.hhs.gov.

Federal Register Notice

Registration Form

Draft Agenda August 1, 2006

Meeting Materials

List of Potentially Hazardous Contaminants in Animal Feed and Feed Ingredients

Determining Health Consequence Scoring for Feed Contaminants


http://www.fda.gov/cvm/AFSS092006PM.htm


DRAFT LIST OF POTENTIALLY HAZARDOUS CONTAMINANTS IN ANIMAL FEED AND FEED INGREDIENTS


1. BIOLOGICAL CONTAMINANTS


A. Transmissible Spongiform Encephalopathies

i. Bovine spongiform encephalopathy (BSE)

ii. Chronic wasting disease (CWD)

B. Microbiological Contaminants

snip...end


http://www.fda.gov/cvm/Documents/FeedContaminants.pdf


Greetings,


I would kindly like to submit the following to ;


Docket No. 2003N-0312 entitled, “List of Potentially Hazardous Contaminants in Animal Feed and Feed Ingredients”
and “Determining Health Consequence Scoring for Feed Contaminants.”


I am very disturbed that other TSE in the USA are not on this list. The USA has the most
documented TSE in the world, all of which have been fed to humans and animals for human consumption.
CJD has been on the rise in the USA, in fact has tripled over the past years, with 'unknown' strains showing
being documented.


WHAT about Scrapie in sheep and goats, and what about atypical scrapie?

WHAT about the atypical TSE in the bovine in Texas and Alabama I.E. BASE ?

WHAT about TME?

DOES this mean all of the above are not any concern in animal feed?

WHAT about blood?


What about all those broken promises on Expanded "Mad Cow" Safeguards Announced
to Strengthen Existing Firewalls Against BSE Transmission that were promised to consumers
on Monday, Jan. 26, 2004 ;


Press Release

FOR IMMEDIATE RELEASE
Monday, Jan. 26, 2004
FDA Press Office
301-827-6242

Expanded "Mad Cow" Safeguards Announced
to Strengthen Existing Firewalls Against BSE Transmission
HHS Secretary Tommy G. Thompson today announced several new public health measures, to be implemented by the Food and Drug Administration (FDA), to strengthen significantly the multiple existing firewalls that protect Americans from exposure to the agent thought to cause bovine spongiform encephalopathy (BSE, also known as mad cow disease) and that help prevent the spread of BSE in U.S. cattle.

The existing multiple firewalls, developed by both the U.S. Department of Agriculture (USDA) and HHS, have been extremely effective in protecting the American consumer from exposure to BSE. The first firewall is based on import controls started in 1989. A second firewall is surveillance of the U.S. cattle population for the presence of BSE, a USDA firewall that led to the finding of the BSE cow in December. The third firewall is FDA's 1997 animal feed ban, which is the critical safeguard to help prevent the spread of BSE through cattle herds by prohibiting the feeding of most mammalian protein to ruminant animals, including cattle. The fourth firewall, recently announced by USDA, makes sure that no bovine tissues known to be at high risk for carrying the agent of BSE enter the human food supply regulated by USDA. The fifth firewall is effective response planning to contain the potential for any damage from a BSE positive animal, if one is discovered. This contingency response plan, which had been developed over the past several years, was initiated immediately upon the discovery of a BSE positive cow in Washington State December 23.

The new safeguards being announced today are science-based and further bolster these already effective safeguards.

Specifically, HHS intends to ban from human food (including dietary supplements), and cosmetics a wide range of bovine-derived material so that the same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that FDA regulates.

FDA will also prohibit certain currently allowed feeding and manufacturing practices involving feed for cattle and other ruminant animals. These additional measures will further strengthen FDA's 1997 "animal feed" rule.

"Today's actions will make strong public health protections against BSE even stronger," Secretary Thompson said. "Although the current animal feed rule provides a strong barrier against the further spread of BSE, we must never be satisfied with the status quo where the health and safety of our animals and our population is at stake. The science and our own experience and knowledge in this area are constantly evolving. Small as the risk may already be, this is the time to make sure the public is protected to the greatest extent possible."

"Today we are bolstering our BSE firewalls to protect the public," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "We are further strengthening our animal feed rule, and we are taking additional steps to further protect the public from being exposed to any potentially risky materials from cattle. FDA's vigorous inspection and enforcement program has helped us achieve a compliance rate of more than 99 percent with the feed ban rule, and we intend to increase our enforcement efforts to assure compliance with our enhanced regulations. Finally, we are continuing to assist in the development of new technologies that will help us in the future improve even further these BSE protections. With today's actions, FDA will be doing more than ever before to protect the public against BSE by eliminating additional potential sources of BSE exposure."

To implement these new protections, FDA will publish two interim final rules that will take effect immediately upon publication, although there will be an opportunity for public comment after publication.

The first interim final rule will ban the following materials from FDA-regulated human food, (including dietary supplements) and cosmetics:

Any material from "downer" cattle. ("Downer" cattle are animals that cannot walk.)
Any material from "dead" cattle. ("Dead" cattle are cattle that die on the farm (i.e. before reaching the slaughter plant);
Specified Risk Materials (SRMs) that are known to harbor the highest concentrations of the infectious agent for BSE, such as the brain, skull, eyes, and spinal cord of cattle 30 months or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age or health; and
The product known as mechanically separated beef, a product which may contain SRMs. Meat obtained by Advanced Meat Recovery (an automated system for cutting meat from bones), may be used since USDA regulations do not allow the presence of SRMs in this product.
The second interim final rule is designed to lower even further the risk that cattle will be purposefully or inadvertently fed prohibited protein. It was the feeding of such protein to cattle that was the route of disease transmission that led to the BSE epidemic in United Kingdom cattle in the 1980's and 1990's.

This interim final rule will implement four specific changes in FDA's present animal feed rule. First, the rule will eliminate the present exemption in the feed rule that allows mammalian blood and blood products to be fed to other ruminants as a protein source. Recent scientific evidence suggests that blood can carry some infectivity for BSE.

Second, the rule will also ban the use of "poultry litter" as a feed ingredient for ruminant animals. Poultry litter consists of bedding, spilled feed, feathers, and fecal matter that are collected from living quarters where poultry is raised. This material is then used in cattle feed in some areas of the country where cattle and large poultry raising operations are located near each other. Poultry feed may legally contain protein that is prohibited in ruminant feed, such as bovine meat and bone meal. The concern is that spillage of poultry feed in the chicken house occurs and that poultry feed (which may contain protein prohibited in ruminant feed) is then collected as part of the "poultry litter" and added to ruminant feed.

Third, the rule will ban the use of "plate waste" as a feed ingredient for ruminants. Plate waste consists of uneaten meat and other meat scraps that are currently collected from some large restaurant operations and rendered into meat and bone meal for animal feed. The use of "plate waste" confounds FDA's ability to analyze ruminant feeds for the presence of prohibited proteins, compromising the Agency's ability to fully enforce the animal feed rule.

Fourth, the rule will further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could lead to cross-contamination.

To accompany these new measures designed to provide a further layer of protection against BSE, FDA will in 2004 step up its inspections of feed mills and renderers. FDA will itself conduct 2,800 inspections and will make its resources go even further by continuing to work with state agencies to fund 3,100 contract inspections of feed mill and renderers and other firms that handle animal feed and feed ingredients. Through partnerships with states, FDA will also receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections in 2004 alone, including annual inspections of 100 percent of all known renderers and feed mills that process products containing materials prohibited in ruminant feed.

"We have worked hard with the rendering and animal feed production industries to try and achieve full compliance with the animal feed rule," said Dr. McClellan, "and through strong education and a vigorous enforcement campaign, backed by additional inspections and resources, we intend to maintain a high level of compliance."

Dr. McClellan also noted that, in response to finding a BSE positive cow in Washington state December 23, FDA inspected and traced products at 22 facilities related to that positive cow or products from the cow, including feed mills, farms, dairy farms, calf feeder lots, slaughter houses, meat processors, transfer stations, and shipping terminals. Moreover, FDA has conducted inspections at the rendering facilities that handled materials from the positive cow, and they were found to be fully in compliance with FDA's feed rule.

To further strengthen protections for Americans, FDA/HHS intends to work with Congress to consider proposals to assure that these important protective measures will be implemented as effectively as possible.

FDA is also continuing its efforts to assist in the development of better BSE science, to achieve the same or greater confidence in BSE protection at a lower cost. For example, to enhance the ability of our public health system to detect prohibited materials in animal feed, FDA will continue to support the development and evaluation of diagnostic tests to identify prohibited materials. These tests would offer a quick and reliable method of testing animal feeds for prohibited materials and for testing other products for contamination with the agent thought to cause BSE.

FDA has publicly discussed many of the measures being announced today with stakeholders in workshops, videoconferences, and public meetings. In addition, FDA published an Advance Notice of Proposed Rulemaking in November 2002 (available online at http://www.fda.gov/OHRMS/DOCKETS/98fr/110602c.htm concerning possible changes to the animal feed rule.

Comprehensive information about FDA's work on BSE and links to other related websites are available at http://www.fda.gov.

###


http://www.fda.gov/bbs/topics/news/2004/hhs_012604.html

Approach:
This project will be done as a Specific Cooperative Agreement with the Italian BSE Reference Laboratory, Istituto Zooprofilattico Sperimentale del Piemonte, in Turin, Italy. It is essential for the U.S. BSE surveillance program to analyze the effectiveness of the U.S diagnostic tools for detection of atypical cases of BSE. Molecular comparisons of the U.S. BSE isolate with atypical BSE isolates will provide further characterization of the U.S. BSE isolate. Transmission studies are already underway using brain homogenates from atypical BSE cases into mice, cattle and sheep. It will be critical to see whether the atypical BSE isolates behave similarly to typical BSE isolates in terms of transmissibility and disease pathogenesis. If transmission occurs, tissue distribution comparisons will be made between cattle infected with the atypical BSE isolate and the U.S. BSE isolate. Differences in tissue distribution could require new regulations regarding specific risk material (SRM) removal.


http://www.ars.usda.gov/research/projects/projects.htm?ACCN_NO=408490

BASE in cattle in Italy of Identification of a second bovine amyloidotic
spongiform encephalopathy: Molecular similarities with

sporadic Creutzfeldt-Jakob disease


http://www.pnas.org/cgi/content/abstract/0305777101v1


REPORT OF THE COMMITTEE ON SCRAPIE

Chair: Dr. Jim Logan, Cheyenne, WY

Vice Chair: Dr. Joe D. Ross, Sonora, TX

Dr. Deborah L. Brennan, MS; Dr. Beth Carlson, ND; Dr. John R. Clifford, DC; Dr. Thomas F. Conner, OH; Dr. Walter E. Cook, WY; Dr. Wayne E. Cunningham, CO; Dr. Jerry W. Diemer, TX; Dr. Anita J. Edmondson, CA; Dr. Dee Ellis, TX; Dr. Lisa A. Ferguson, MD; Dr. Keith R. Forbes, NY; Dr. R. David Glauer, OH; Dr. James R. Grady, CO; Dr. William L. Hartmann, MN; Dr. Carolyn Inch, CAN; Dr. Susan J. Keller, ND; Dr. Allen M. Knowles, TN; Dr. Thomas F. Linfield, MT; Dr. Michael R. Marshall, UT; Dr. Cheryl A. Miller, In; Dr. Brian V. Noland, CO; Dr. Charles Palmer, CA; Dr. Kristine R. Petrini, MN; Mr. Stan Potratz, IA; Mr. Paul E. Rodgers, CO; Dr. Joan D. Rowe, CA; Dr. Pamela L. Smith, IA; Dr. Diane L. Sutton, MD; Dr. Lynn Anne Tesar, SD; Dr. Delwin D. Wilmot, NE; Dr. Nora E. Wineland, CO; Dr. Cindy B. Wolf, MN.

The Committee met on November 9, 2005, from 8:00am until 11:55am, Hershey Lodge and Convention Center, Hershey, Pennsylvania. The meeting was called to order by Dr. Jim Logan, chair, with vice chairman Dr. Joe D. Ross attending. There were 74 people in attendance.

The Scrapie Program Update was provided by Dr. Diane Sutton, National Scrapie Program Coordinator, United States Department of Agriculture (USDA), Animal and Plant Health Inspection Services (APHIS), Veterinary Services (VS). The complete text of the Status Report is included in these Proceedings.

Dr. Patricia Meinhardt, USDA-APHIS-VS-National Veterinary Services Laboratory (NVSL) gave the Update on Genotyping Labs and Discrepancies in Results. NVSL conducts investigations into discrepancies on genotype testing results associated with the Scrapie Eradication Program. It is the policy of the Program to conduct a second genotype test at a second laboratory on certain individual animals. Occasionally, there are discrepancies in those results. The NVSL conducts follow-up on these situations through additional testing on additional samples from the field and archive samples from the testing laboratories.

For the period of time from January 1, 2005, until October 15, 2005, there were 23 instances of discrepancies in results from 35 flocks. Of those 23 instances, 14 were caused by laboratory error (paperwork or sample mix-up), 3 results from field error, 5 were not completely resolved, and 1 originated from the use of a non-approved laboratory for the first test. As a result of inconsistencies, one laboratory’s certification was revoked by APHIS-VS.

To reduce/eliminate these problems, the Program has placed additional quality requirements on the testing laboratories: additional review of final reports, additional coding systems for testing operations, strict follow-up and reports to NVSL on corrective actions, dual data entry systems, and more frequent inspections.

The Agricultural Research Services (ARS) Scrapie Research Update was given by Janet Alverson, USDA- ARS. Dr. Alverson reported on the effect of multiple births and fetal position within the uterus on PrP-Sc accumulation in fetal cotyledons. Fetal cotyledons of fetuses with

resistant genotypes can accumulate PrP-Sc when positioned next to a fetus of susceptible genotype with cotyledons positive for PrP-Sc accumulation.

Scrapie Surveillance Evaluation Working Group Update was presented by Tracey Lynn, Epidemiologist with the National Surveillance Unit, Center for Epidemiology and Animal Health (CEAH). The presentation provided a background on evaluation, a quick review of analyses completed to date by the scrapie surveillance evaluation working group, and some of the preliminary findings. The process of surveillance system evaluation is undertaken to assist a disease control program with identifying possible improvements to their surveillance system, and includes an assessment of the overall utility of the system, identification of potential gaps in coverage, and an evaluation of the overall performance of the system. The scrapie surveillance evaluation working group reviewed the structure and processes of the scrapie surveillance program, as well as various quality and effectiveness measures.

Overall, 98-99% of surveillance samples come from the Regulatory Scrapie Surveillance System (RSSS), so the RSSS system has been the primary focus of the evaluation process. The working group developed a flow chart indicating the flow of sheep through RSSS, which identified potential gaps in surveillance coverage, including custom kill plants and sheep being exported to Mexico. Spatial analyses can assist in identifying areas with high density sheep populations with lower levels of RSSS sampling. Identification compliance is being evaluated by reviewing reports from slaughter plants on the proportion of animals with appropriate identification. Additional analyses remain, including defining the most appropriate economic analyses, and comparing the surveillance system with developing surveillance standards. The working group hopes to have a draft written report for review by the end of the year.

Giving the Update on Scrapie Diagnostics and Susceptibility was Katherine O’Roarke, Research Microbiologist, USDA-ARS. "What’s New in Scrapie" -- Biopsy sampling of the third eyelid or tonsillar lymphoid tissue is a useful live animal test for scrapie. The biopsy sample is examined for accumulation of the abnormal prion protein using immunohistochemistry. A joint project conducted by the Veterinary Laboratory Agencies and the Moredun Institute in the United Kingdom has developed an alternative technique in which tissue is collected from the narrow band of lymphoid tissue near the rectal-anal junction. The morphology of the lymphoid follicles is similar in the tonsil, retropharyngeal lymph nodes, third eyelid, and rectal-anal mucosal tissue. A report on more than 300 sheep in the United Kingdom (UK), prepared by Drs. Lorenzo Gonzalez and Jeffrey Martin, will describe the sensitivity, specificity, and optimal collection interval for this technique in a variety of breeds of British sheep. ARS has done a preliminary evaluation of the technique in US sheep. Samples of third eyelid and rectal-mucosal tissue were collected from 56 sheep. Forty-two (42) sheep had negative biopsies at both sites; most of these sheep have been necropsied and no PrP-d was found in retropharyngeal lymph node or tonsil, showing good agreement with the antemortem biopsies. Fourteen (14) sheep had positive rectal biopsy samples; of those, only 12 had positive eyelid biopsies. These sheep will be monitored for disease development. However, the protocol is identical for all samples and it is probable that these sheep represent false negative third eyelid results. Abstracts of reports on the UK studies indicate that sensitivity of the test was 70% in the UK; similar large scale testing on US sheep is necessary. The biopsy tissue is somewhat difficult to handle in the tissue processing laboratory and adaptation to an ELISA format may improve test performance.

Alexia McKnight, Assistant Professor of Radiology, University of Pennsylvania, reviewed magnetic resonance imaging (MRI) diagnostics before the committee. A synopsis containing references is attached at the end of this report. Dr. McKnight asked the question, "could MRI be a cost-effective screening test, estimated at $25-30 each with results immediately available." The committee feels that it is not practical as compared to other alternatives currently available. However, the committee expressed interest in future reference to this technology.

Dr. Diane Sutton lead the Uniform Methods and Rules (UM&R) and Regulatory Issues Discussion. Several modifications to the UM&R were discussed. Eight issues were identified and communicated to the APHIS scrapie program coordinator. The committee acknowledged that APHIS and the industry is adequately addressing the year-to-year industry concerns.

Dr. Kris Petrini representing the North Central United States Animal Health Association District presented five recommendations to the Committee. During the discussions regarding these recommendations it was evident that all five issues had been addressed during the year at this Committee meeting.

The Committee approved a recommendation that USDA-APHIS-VS continue to provide indemnity funds for animals that have been designated for testing in Flocks Under Investigation as an alternative to third eyelid testing after consultation with the designated Scrapie Epidemiologist (DSE) and the Regional Area Epidemiologist (RAE).

The 2004 Resolutions along with their responses were reviewed by the Committee.

A Resolution concerning premises registration and identification was approved by the Committee and forwarded to the Committee on Nominations and Resolutions.

Committee on Scrapie

Status Report-Fiscal Year 2005: Cooperative State-Federal Scrapie Eradication Program

Submitted by Diane Sutton, DVM and Gary Ross, DVM

National Center for Animal Health Programs, APHIS, USDA

In Fiscal Year 2005 the Scrapie Eradication Program focused on: (1) utilization of a genetic based approach to flock clean-up plans; (2) cleaning up infected and source flocks; (3) tracing and testing exposed animals and flocks; (4) expansion of regulatory slaughter surveillance (RSSS); (5) conducting considtent state reviews, (6) producer education; (7) upgrading of the Scrapie National Generic Database and (8) publishing the updated Scrapie Eradication Uniform Methods and Rules (UM&R). The current Scrapie Eradication UM&R is posted at http://www.aphis.usda.gov/vs/nahps/scrapie/umr-scrapie-erad.pdf.

Consistent State Reviews

States must meet the requirements in 9 CFR 79.6 in order to move sheep and goats in interstate commerce with minimal restrictions. Twenty seven states have enacted the required identification rules, the remaining states have submitted a work plan that describes the steps that will be taken to comply and provided a timeline for completing significant milestones. USDA is conducting onsite scrapie program consistent state reviews and has completed reviews in 12 states. States must be in full compliance by the end of their current rule making cycle. States not in full compliance at that time will be removed from the consistent state list. Removal from the list would create a significant impact on the interstate movement of sheep and goats from those States.

Scrapie Flock Certification Program

As of September 30, 2005, there were 1,961 flocks participating in the Scrapie Flock Certification Program (SFCP). Of these flocks 188 were certified flocks, 1,770 were complete monitored flocks, and 3 were selective monitored flocks (figure 2). There were 209 flocks newly enrolled and 53 newly certified (13 with status dates in FY 2005 and 40 with status dates in previous years) in FY 2005 (figure 3).

Infected and Source Flocks

As of September 30, 2005, there were 105 scrapie infected and source flocks. There were a total of 165** new infected and source flocks reported for FY 2005. The total infected and source flocks that have been released in FY 2005 was 128. The ratio of infected and source flocks cleaned up or placed on clean up plans vs. new infected and source flocks discovered in FY 2005 was 1.03 : 1*. In addition 622 scrapie cases were confirmed and reported by the National Veterinary Services Laboratories (NVSL) in FY 2005, of which 130 were RSSS cases. Fifteen cases of scrapie in goats have been reported since 1990. The last goat case was reported in May 2005. Approximately 5,626 animals were indemnified comprised of 49% non-registered sheep, 45% registered sheep, 1.4% non-registered goats and 4.6% registered goats.

Regulatory Scrapie Slaughter Surveillance (RSSS)

RSSS was designed to utilize the findings of the Center for Epidemiology and Animal Health (CEAH) Scrapie: Ovine Slaughter Surveillance (SOSS) study. The results of SOSS can be found at http://www.aphis.usda.gov/vs/ceah/cahm/Sheep/sheep.htm . RSSS started April 1,

2003. It is a targeted slaughter surveillance program which is designed to identify infected flocks for clean-up. During FY 2005 collections increased by 32% overall and by 90% for black and mottled faced sheep improving overall program effectiveness and efficiency as demonstrated by the 26% decrease in percent positive black faced sheep compared to FY 2004. Samples have been collected from 62,864 sheep since April 1, 2003, of which results have been reported for 59,105 of which 209 were confirmed positive. During FY 2005, 33,137 samples were collected from 81 plants. There have been 130 NVSL confirmed positive cases (30 collected in FY 2004 and confirmed in FY 2005 and 100 collected and confirmed in FY 2005) in FY 2005. Face colors of these positives were 114 black, 14 mottled, 1 white and 1 unknown. The percent positive by face color is shown in the chart below.

Scrapie Testing

In FY 2005, 35,845 animals have been tested for scrapie: 30,192 RSSS; 4,742 regulatory field cases; 772 regulatory third eyelid biopsies; 10 third eyelid validations; and 129 necropsy validations (chart 9).

Animal ID

As of October 04, 2005, 103,580 sheep and goat premises have been assigned identification numbers in the Scrapie National Generic Database. Official eartags have been issued to 73,807 of these premises.

*This number based on an adjusted 12 month interval to accommodate the 60 day period for setting up flock plans.


http://www.usaha.org/committees/reports/2005/report-scr-2005.pdf


Published online before print October 20, 2005

Proc. Natl. Acad. Sci. USA, 10.1073/pnas.0502296102
Medical Sciences

A newly identified type of scrapie agent can naturally infect sheep with resistant PrP genotypes

( sheep prion | transgenic mice )

Annick Le Dur *, Vincent Béringue *, Olivier Andréoletti , Fabienne Reine *, Thanh Lan Laï *, Thierry Baron , Bjørn Bratberg ¶, Jean-Luc Vilotte ||, Pierre Sarradin **, Sylvie L. Benestad ¶, and Hubert Laude *
*Virologie Immunologie Moléculaires and ||Génétique Biochimique et Cytogénétique, Institut National de la Recherche Agronomique, 78350 Jouy-en-Josas, France; Unité Mixte de Recherche, Institut National de la Recherche Agronomique-Ecole Nationale Vétérinaire de Toulouse, Interactions Hôte Agent Pathogène, 31066 Toulouse, France; Agence Française de Sécurité Sanitaire des Aliments, Unité Agents Transmissibles Non Conventionnels, 69364 Lyon, France; **Pathologie Infectieuse et Immunologie, Institut National de la Recherche Agronomique, 37380 Nouzilly, France; and ¶Department of Pathology, National Veterinary Institute, 0033 Oslo, Norway


Edited by Stanley B. Prusiner, University of California, San Francisco, CA, and approved September 12, 2005 (received for review March 21, 2005)

Scrapie in small ruminants belongs to transmissible spongiform encephalopathies (TSEs), or prion diseases, a family of fatal neurodegenerative disorders that affect humans and animals and can transmit within and between species by ingestion or inoculation. Conversion of the host-encoded prion protein (PrP), normal cellular PrP (PrPc), into a misfolded form, abnormal PrP (PrPSc), plays a key role in TSE transmission and pathogenesis. The intensified surveillance of scrapie in the European Union, together with the improvement of PrPSc detection techniques, has led to the discovery of a growing number of so-called atypical scrapie cases. These include clinical Nor98 cases first identified in Norwegian sheep on the basis of unusual pathological and PrPSc molecular features and "cases" that produced discordant responses in the rapid tests currently applied to the large-scale random screening of slaughtered or fallen animals. Worryingly, a substantial proportion of such cases involved sheep with PrP genotypes known until now to confer natural resistance to conventional scrapie. Here we report that both Nor98 and discordant cases, including three sheep homozygous for the resistant PrPARR allele (A136R154R171), efficiently transmitted the disease to transgenic mice expressing ovine PrP, and that they shared unique biological and biochemical features upon propagation in mice. These observations support the view that a truly infectious TSE agent, unrecognized until recently, infects sheep and goat flocks and may have important implications in terms of scrapie control and public health.


--------------------------------------------------------------------------------

Author contributions: H.L. designed research; A.L.D., V.B., O.A., F.R., T.L.L., J.-L.V., and H.L. performed research; T.B., B.B., P.S., and S.L.B. contributed new reagents/analytic tools; V.B., O.A., and H.L. analyzed data; and H.L. wrote the paper.

A.L.D. and V.B. contributed equally to this work.

To whom correspondence should be addressed.

Hubert Laude, E-mail: laude@jouy.inra.fr

www.pnas.org/cgi/doi/10.1073/pnas.0502296102


http://www.pnas.org/cgi/content/abstract/0502296102v1


12/10/76
AGRICULTURAL RESEARCH COUNCIL
REPORT OF THE ADVISORY COMMITTE ON SCRAPIE
Office Note
CHAIRMAN: PROFESSOR PETER WILDY

snip...

A The Present Position with respect to Scrapie
A] The Problem

Scrapie is a natural disease of sheep and goats. It is a slow
and inexorably progressive degenerative disorder of the nervous system
and it ia fatal. It is enzootic in the United Kingdom but not in all
countries.

The field problem has been reviewed by a MAFF working group
(ARC 35/77). It is difficult to assess the incidence in Britain for
a variety of reasons but the disease causes serious financial loss;
it is estimated that it cost Swaledale breeders alone $l.7 M during
the five years 1971-1975. A further inestimable loss arises from the
closure of certain export markets, in particular those of the United
States, to British sheep.

It is clear that scrapie in sheep is important commercially and
for that reason alone effective measures to control it should be
devised as quickly as possible.

Recently the question has again been brought up as to whether
scrapie is transmissible to man. This has followed reports that the
disease has been transmitted to primates. One particularly lurid
speculation (Gajdusek 1977) conjectures that the agents of scrapie,
kuru, Creutzfeldt-Jakob disease and transmissible encephalopathy of
mink are varieties of a single "virus". The U.S. Department of
Agriculture concluded that it could "no longer justify or permit
scrapie-blood line and scrapie-exposed sheep and goats to be processed
for human or animal food at slaughter or rendering plants" (ARC 84/77)"
The problem is emphasised by the finding that some strains of scrapie
produce lesions identical to the once which characterise the human
dementias"

Whether true or not. the hypothesis that these agents might be
transmissible to man raises two considerations. First, the safety
of laboratory personnel requires prompt attention. Second, action
such as the "scorched meat" policy of USDA makes the solution of the
acrapie problem urgent if the sheep industry is not to suffer
grievously.

snip...

76/10.12/4.6

http://www.bseinquiry.gov.uk/files/yb/1976/10/12004001.pdf

Neurobiology
Adaptation of the bovine spongiform encephalopathy agent to primates and
comparison with Creutzfeldt- Jakob disease: Implications for human health
Corinne Ida Lasmézas*,, Jean-Guy Fournier*, Virginie Nouvel*, Hermann Boe*,
Domíníque Marcé*, François Lamoury*, Nicolas Kopp, Jean-Jacques Hauw§, James
Ironside¶, Moira Bruce, Dominique Dormont*, and Jean-Philippe Deslys*
* Commissariat à l'Energie Atomique, Service de Neurovirologie, Direction
des Sciences du Vivant/Département de Recherche Medicale, Centre de
Recherches du Service de Santé des Armées 60-68, Avenue du Général Leclerc,
BP 6, 92 265 Fontenay-aux-Roses Cedex, France; Hôpital Neurologique Pierre
Wertheimer, 59, Boulevard Pinel, 69003 Lyon, France; § Laboratoire de
Neuropathologie, Hôpital de la Salpêtrière, 83, Boulevard de l'Hôpital,
75013 Paris, France; ¶ Creutzfeldt-Jakob Disease Surveillance Unit, Western
General Hospital, Crewe Road, Edinburgh EH4 2XU, United Kingdom; and
Institute for Animal Health, Neuropathogenesis Unit, West Mains Road,
Edinburgh EH9 3JF, United Kingdom

Edited by D. Carleton Gajdusek, Centre National de la Recherche
Scientifique, Gif-sur-Yvette, France, and approved December 7, 2000
(received for review October 16, 2000)


Abstract

There is substantial scientific evidence to support the notion that bovine
spongiform encephalopathy (BSE) has contaminated human beings, causing
variant Creutzfeldt-Jakob disease (vCJD). This disease has raised concerns
about the possibility of an iatrogenic secondary transmission to humans,
because the biological properties of the primate-adapted BSE agent are
unknown. We show that (i) BSE can be transmitted from primate to primate by
intravenous route in 25 months, and (ii) an iatrogenic transmission of vCJD
to humans could be readily recognized pathologically, whether it occurs by
the central or peripheral route. Strain typing in mice demonstrates that the
BSE agent adapts to macaques in the same way as it does to humans and
confirms that the BSE agent is responsible for vCJD not only in the United
Kingdom but also in France. The agent responsible for French iatrogenic
growth hormone-linked CJD taken as a control is very different from vCJD but
is similar to that found in one case of sporadic CJD and one sheep scrapie
isolate. These data will be key in identifying the origin of human cases of
prion disease, including accidental vCJD transmission, and could provide
bases for vCJD risk assessment.


http://www.pnas.org/cgi/content/full/041490898v1


The EMBO Journal, Vol. 19, No. 17 pp. 4425-4430, 2000
© European Molecular Biology Organization

Evidence of a molecular barrier limiting
susceptibility of humans, cattle and sheep to
chronic wasting disease

G.J. Raymond1, A. Bossers2, L.D. Raymond1, K.I. O?Rourke3,
L.E. McHolland4, P.K. Bryant III4, M.W. Miller5, E.S. Williams6, M.
Smits2
and B. Caughey1,7

1NIAID/NIH Rocky Mountain Laboratories, Hamilton, MT 59840,
3USDA/ARS/ADRU, Pullman, WA 99164-7030, 4USDA/ARS/ABADRL,
Laramie, WY 82071, 5Colorado Division of Wildlife, Wildlife Research
Center, Fort Collins, CO 80526-2097, 6Department of Veterinary Sciences,
University of Wyoming, Laramie, WY 82070, USA and 2ID-Lelystad,
Institute for Animal Science and Health, Lelystad, The Netherlands
7Corresponding author e-mail: bcaughey@nih.gov Received June 7, 2000;
revised July 3, 2000; accepted July 5, 2000.

Abstract

Chronic wasting disease (CWD) is a transmissible
spongiform encephalopathy (TSE) of deer and elk,
and little is known about its transmissibility to other
species. An important factor controlling
interspecies TSE susceptibility is prion protein (PrP)
homology between the source and recipient
species/genotypes. Furthermore, the efficiency with which
the protease-resistant PrP (PrP-res) of one
species induces the in vitro conversion of the normal PrP
(PrP-sen) of another species to the
protease-resistant state correlates with the cross-species
transmissibility of TSE agents. Here we
show that the CWD-associated PrP-res (PrPCWD) of cervids
readily induces the conversion of recombinant cervid PrP-sen
molecules to the protease-resistant state in accordance
with the known transmissibility of CWD between cervids. In contrast,
PrPCWD-induced conversions of human and bovine PrP-sen were
much less efficient, and conversion of ovine PrP-sen was
intermediate. These results demonstrate a barrier at the
molecular level that should limit the susceptibility of these non-cervid
species to CWD.

snip...

Clearly, it is premature to draw firm conclusions about CWD
passing naturally into humans, cattle and sheep, but the present
results suggest that CWD transmissions to humans would be as
limited by PrP incompatibility as transmissions of BSE or sheep
scrapie to humans. Although there is no evidence that sheep
scrapie has affected humans, it is likely that BSE has caused variant
CJD in 74 people (definite and probable variant CJD cases to
date according to the UK CJD Surveillance Unit). Given the
presumably large number of people exposed to BSE infectivity,
the susceptibility of humans may still be very low compared with
cattle, which would be consistent with the relatively inefficient
conversion of human PrP-sen by PrPBSE. Nonetheless, since
humans have apparently been infected by BSE, it would seem prudent
to take reasonable measures to limit exposure of humans
(as well as sheep and cattle) to CWD infectivity as has been
recommended for other animal TSEs.

snip...

http://www.emboj.org/current.shtml


Oral transmission of kuru, Creutzfeldt-Jakob disease, and scrapie to
nonhuman primates.

Gibbs CJ Jr, Amyx HL, Bacote A, Masters CL, Gajdusek DC.

Kuru and Creutzfeldt-Jakob disease of humans and scrapie disease of
sheep and goats were transmitted to squirrel monkeys (Saimiri sciureus) that
were exposed to the infectious agents only by their nonforced consumption of
known infectious tissues. The asymptomatic incubation period in the one
monkey exposed to the virus of kuru was 36 months; that in the two monkeys
exposed to the virus of Creutzfeldt-Jakob disease was 23 and 27 months,
respectively; and that in the two monkeys exposed to the virus of scrapie
was 25 and 32 months, respectively. Careful physical examination of the
buccal cavities of all of the monkeys failed to reveal signs or oral
lesions. One additional monkey similarly exposed to kuru has remained
asymptomatic during the 39 months that it has been under observation.


PMID: 6997404


http://www.ncbi.nlm.nih.gov/entrez/query.fcgicmd=Retrieve&db=PubMed&list_uids=6997404&dopt=Abstract


Subject: SCRAPIE and CWD USA UPDATE July 19, 2006
Date: July 19, 2006 at 12:06 pm PST
SCRAPIE USA UPDATE MAY 31, 2006


Infected and Source Flocks

As of May 31, 2006, there were 93 scrapie infected and source flocks (Figure 3). There were 12 new infected and source flocks reported in May (Figure 4) with a total of 67 flocks reported for FY 2006 (Figure 5). The total infected and source flocks that have been released in FY 2006 are 53 (Figure 6), with 7 flocks released in May. The ratio of infected and source flocks released to newly infected and source flocks for FY 2006 = 0.79 : 1. In addition, as of May 31, 2006, 216 scrapie cases have been confirmed and reported by the National Veterinary Services Laboratories (NVSL), of which 33 were RSSS cases (Figure 7). This includes 33 newly confirmed cases in May 2006 (Figure 8). Eighteen cases of scrapie in goats have been reported since 1990 (Figure 9). The last goat case was reported in March 2006. New infected flocks, source flocks, and flocks released for FY 2006 are depicted in Chart 3. New infected and source statuses from 1997 to 2006 are depicted in Chart 4.

snip...

Scrapie Testing

In FY 2006, 26,185 animals have been tested for scrapie : 22,634 RSSS*; 2063 regulatory field cases; 61 necropsy validations, 5 rectal biopsy and 1427 regulatory third eyelid biopsies (Chart 9). ...

snip...END

http://www.aphis.usda.gov/vs/nahps/scrapie/monthly_report/monthly-report.html

DECLARATION OF EXTRAORDINARY EMERGENCY BECAUSE OF AN ATYPICAL T.S.E. (PRION DISEASE) OF FOREIGN ORIGIN IN THE UNITED STATES

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2000_register&docid=fr20jy00-31

DECLARATION OF EXTRAORDINARY EMERGENCY BECAUSE OF AN ATYPICAL T.S.E (PRION DISEASE) OF FOREIGN ORIGIN IN THE UNITED STATES [2]

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2000_register&docid=fr20jy00-32

Mink pelt production in the United States in 2005 totaled
2.63 million pelts, up 3 percent from 2004. Wisconsin, the largest
mink producing State, produced 778,000 pelts. Utah the second
largest producing State, produced 600,000 pelts.

The number of pelts by color class as a percent of the total U.S.
production in 2005 is as follows: Black at 47.6 percent, Mahogany
at 20.9 percent, Blue Iris at 11.3 percent, Demi/Wild at
6.3 percent, Sapphire at 4.0 percent, and White at 3.8 percent.
The remaining color classes accounted for 6.1 percent.

Value of Pelt Production Up 33 Percent

Mink pelts produced during the 2005 crop year were valued at
$160 million, up 33 percent from $120 million a year ago. The
average price per pelt for the 2005 crop year was $60.90, up from
$47.10 in 2004. .....snip.......end

http://usda.mannlib.cornell.edu/reports/nassr/other/zmi-bb/mink0706.pdf


TME

http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/fs_ahtme.html


Title: Experimental Inoculation of Tme, Scrapie, and Cwd to Raccoons: An Update

Authors

Hamir, Amirali
Miller, Janice - ARS RETIRED
Cutlip, Randall - ARS RETIRED
Stack, Mick - VLA-WEYBRIDGE, UK
Chaplin, Melanie - VLA-WEYBRIDGE, UK
Bartz, Jason - CREIGHTON UNIVERSITY
Jenny, Allen - USDA, APHIS, NVSL
Williams, Elizabeth - UNIVERSITY OF WYOMING


Submitted to: Meeting Abstract
Publication Type: Abstract
Publication Acceptance Date: September 29, 2004
Publication Date: October 14, 2004
Citation: Hamir, A., Miller, J., Cutlip, R., Stack, M., Chaplin, M., Bartz, J., Jenny, A., Williams, E. 2004. Experimental Inoculation of Tme, Scrapie, and Cwd to Raccoons: An Update [abstract]. Animal Prion Diseases and the Americas. P. 79.

Technical Abstract: Raccoons (Procyon lotor) are omnivorous and their diet may include carrion. It is, therefore, possible that in the wild they may get exposed to carcasses of animals with transmissible spongiform encephalopathies (TSEs). To determine the susceptibility of raccoons to transmissible mink encephalopathy (TME), scrapie, and chronic wasting disease (CWD), each of these agents was inoculated intracerebrally into a group of 4 kits. Three uninoculated kits served as controls. All raccoons in the TME-inoculated group developed neurologic signs and were euthanized within 6 months post inoculation (PI). In the scrapie-inoculated group, 3 animals became sick and were euthanized between 18 - 22 PI. Although the fourth raccoon in this group did not show any clinical signs, it was euthanized at 24 months PI. At necropsy all clinically affected raccoons had extensive microscopic lesions of spongiform encephalopathy and protease-resistant prion protein (PrPres) was detected in the CNS by immunohistochemistry and Western blot. In the CWD-inoculated group, 1 raccoon was euthanized at 39 months PI because of severe cystitis. Its brain was negative for PrPres. At present, 5 years PI, the 3 remaining CWD-inoculated raccoons are alive and apparently healthy. They will be kept under observation for further period of 1 year (i.e 6 years PI) when the experiment will be terminated. These preliminary findings demonstrate that TME and scrapie can be transmitted to raccoons within 6 months and 2 years, respectively, whereas CWD cannot. Based on these incubation periods, it may be possible to differentiate these 3 TSEs. Such a laboratory model would be relatively simple, fast and inexpensive for strain-typing of unknown TSEs in the United States. Now that the relative susceptibiity to IC transmission of each TSE has been established, oral transmission studies of TSEs to raccoons are planned.

Last Modified: 07/14/2006


http://www.ars.usda.gov/research/publications/publications.htm?seq_no_115=167761


Research Project: Transmission, Differentiation, and Pathobiology of Transmissible Spongiform Encephalopathies
Location: Virus and Prion Diseases of Livestock

Title: Experimental Transmission of Transmissible Mink Encephalopathy (Tme) to Cattle by Intracerebral Inoculation


Authors

Hamir, Amirali
Kunkle, Robert
Miller, Janice - ARS RETIRED
Greenlee, Justin
Richt, Juergen


Submitted to: International Veterinary Vaccines and Diagnostics Conference
Publication Type: Abstract
Publication Acceptance Date: March 15, 2006
Publication Date: June 25, 2006
Citation: Hamir, A.N., Kunkle, R.A., Miller, J.M., Greenlee, J.J., Richt, J.A. 2006. Experimental Transmission of Transmissible Mink Encephalopathy (Tme) to Cattle by Intracerebral Inoculation [abstract]. 4th International Veterinary Vaccines and Diagnostics Conference. P. 89. Paper No. Po53.

Technical Abstract: To compare clinicopathological findings of transmissible mink encephalopathy (TME) with other transmissible spongiform encephalopathies (TSE, prion diseases) that have been shown to be experimentally transmissible to cattle (sheep scrapie, and chronic wasting disease, CWD), 2 groups of calves (n = 4 each) were intracerebrally inoculated with TME agents from 2 different sources (mink with TME and a bovine with TME). Two uninoculated calves served as controls. Within 15.3 months post inoculation (PI), all animals from both inoculated groups developed clinical signs of central nervous system (CNS) abnormality; their CNS tissues had microscopic spongiform encephalopathy (SE); and PrP**res was detected in their CNS tissues by immunohistochemistry (IHC) and Western blot (WB) techniques. These findings demonstrate that intracerebrally inoculated cattle not only amplify TME PrP**res but also develop clinical CNS signs and extensive lesions of SE. The latter has not been shown with other TSE agents (scrapie and CWD) similarly inoculated into cattle. The findings also suggest that the diagnostic techniques currently used for confirmation of bovine spongiform encephalopathy (BSE) would detect TME in cattle should it occur naturally. However, it would be a diagnostic challenge to differentiate TME in cattle from BSE. Our recent preliminary results indicate that WB may be able to differentiate between bovine TME and BSE.


http://www.ars.usda.gov/research/publications/publications.htm?seq_no_115=191825


Research Project: Transmission, Differentiation, and Pathobiology of Transmissible Spongiform Encephalopathies
Location: Virus and Prion Diseases of Livestock

Title: First and Second Cattle Passage of Transmissible Mink Encephalopathy (Tme) by Intracerebral Inoculation


Authors

Hamir, Amirali
Kunkle, Robert
Miller, Janice - ARS RETIRED
Bartz, J - CREIGHTON UNIVERSITY
Richt, Juergen


Submitted to: Veterinary Pathology
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: August 12, 2005
Publication Date: March 1, 2006
Citation: Hamir, A.N., Kunkle, R.A., Miller, J.M., Bartz, J.C., Richt, J.A. 2006. First and Second Cattle Passage of Transmissible Mink Encephalopathy (Tme) by Intracerebral Inoculation. Veterinary Pathology. 43(2):118-126.

Interpretive Summary: Transmissible mink encephalopathy (TME) is a fatal neurologic disease. It is similar to bovine spongiform encephalopathy (BSE) or mad cow disease. To compare TME infection with other similar diseases in cattle, 2 groups of calves were inoculated in the brain with TME agents from 2 different sources. Two uninoculated calves served as controls. Within 15.3 months post inoculation, animals from both inoculated groups developed clinical signs of central nervous system (CNS) abnormality. Laboratory tests revealed lesions and presence of the TME agent in their tissues. Both findings could not be differentiated from those seen in BSE. Our findings also demonstrated that the laboratory tests that are currently used for BSE surveillance would detect TME in cattle should it occur naturally. However, it would be a diagnostic challenge to differentiate TME in cattle from BSE by clinical signs or laboratory tests that are currently available. Results of this study will have an impact on directing future research on TSEs to search for specific laboratory tests to differentiate BSE from TME in cattle.
Technical Abstract: To compare clinicopathological findings of transmissible mink encephalopathy (TME) with other transmissible spongiform encephalopathies (TSE, prion diseases) that have been shown to be experimentally transmissible to cattle (sheep scrapie, and chronic wasting disease, CWD), 2 groups of calves (n = 4 each) were intracerebrally inoculated with TME agents from 2 different sources (mink with TME and a bovine with TME). Two uninoculated calves served as controls. Within 15.3 months post inoculation (PI), animals from both inoculated groups developed clinical signs of central nervous system (CNS) abnormality; their CNS tissues had microscopic spongiform encephalopathy (SE); and PrPres was detected in their CNS tissues by immunohistochemistry (IHC) and Western blot (WB) techniques. These findings demonstrate that intracerebrally inoculated cattle not only amplify TME PrPres but also develop clinical CNS signs and extensive lesions of SE. The latter has not been shown with other TSE agents (scrapie and CWD) similarly inoculated into cattle. The findings also demonstrate that the diagnostic techniques currently used for bovine spongiform encephalopathy (BSE) surveillance would detect TME in cattle should it occur naturally. However, it would be a diagnostic challenge to differentiate TME in cattle from BSE by clinical signs, neuropathology, or the presence of PrPres by IHC and WB.


http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=173819


SECTION ONE

EXECUTIVE SUMMARY


http://www.fda.gov/cvm/Documents/bse1.pdf

SECTION TWO

INTRODUCTION AND PROFILE

OF THE MEAT ANIMAL PRODUCING, SLAUGHTERING,

AND RENDERING INDUSTRIES

The U.S. Food and Drug Administration (FDA) is considering regulatory options to reduce

the risk of an outbreak of transmissible spongiform encephalopathies (TSE) in the United States.

In the United Kingdom, one form of TSE, bovine spongiform encephalopathy (BSE), is believed

to be linked to cattle feed containing rendered protein by-products from sheep and goats infected

with scrapie, a disease that is related to BSE.

The FDA regulatory actions will affect a spectrum of agricultural producers including

renderers, slaughterers, animal producers, and animal feed producers. After introducing the FDA

options under consideration (see Section 2.1), this discussion introduces the various industry

components and discusses their composition, size, and scale of economic activity. Among the

affected animal producers are cattle, sheep, and goat producers.

2.1 THE PROPOSED FDA REGULATION

FDA is considering five regulatory options:

# A prohibition on all mammalian protein in ruminant feed.

# A prohibition of all ruminant protein in ruminant feed.

# A prohibition on the inclusion of designated tissues in ruminant feed. This option

specifies that ruminant feed is not generally recognized as safe if it includes (1)

bovine brain, spinal cord, distal ileum, and eyes; (2) any and all protein that is

derived from any portions of the ovine (sheep family), caprine (goat family),

cervine (deer family), and mink; or (3) dead, dying, disabled, or diseased bovine.

# A prohibition on the inclusion of protein derived from sheep (including lamb),

goats, deer, elk, and mink in ruminant feed.

# A prohibition on the inclusion of protein derived from sheep (including lamb) and

goats in ruminant feed.

Under these prohibitions, any component of ruminant feed containing prohibited

ingredients will be considered adulterated within the meaning of the Federal Food, Drug, and

Cosmetic Act. The regulatory options would not place restrictions on the use of ruminant protein

by-products for uses other than as an ingredient in ruminant feed nor would they restrict the use of

ruminant derived fats and tallows.

2.2 PROFILE OF CATTLE RANCHERS

snip...

2.8 PROFILE OF MINK PRODUCERS

Mink are raised for their pelts and oil. Most mink farmers kill and pelt their own animals

once a year near the end of November or in early December. Once the pelts are removed, the fat is

then scrapped from the hide. This fat is used to manufacture mink oil that is sought for cosmetic

uses because of its hypoallergenic qualities and in leather treatments. The total value of mink

production in 1995 was $143 million, an increase of 72 percent from 1994.

In 1995, 446 mink farms produced a total of 2.69 million pelts (NASS, 1996b). Mink

producers vary in size but most are small operations. Mink farming is concentrated in Utah (130

2-11

farms), Wisconsin (77 farms), and Minnesota (52 farms). There has been recent consolidation

within the industry, with the number of farms decreasing by 8 percent from 1993 to 1994 and 3

percent from 1994 to 1995. The market price for mink pelts is subject to wide demand fluctuations

based on fashion and weather.

Once the pelt and fat are removed, the entire carcass is then rendered. Mink carcasses sent

to rendering (minus the pelt and fat) weigh an average of 2.5 pounds, so the total estimated offal

produced per year is 6.7 million pounds. Mink farmers are reported to have difficulty with getting

renderers to pick-up their material because of its low volume and the infrequency of offal

generation.


snip...


http://www.fda.gov/cvm/Documents/bse2.pdf

bse3

http://www.fda.gov/cvm/Documents/bse3.pdf

Re: Docket No. 04-047-1, Federal Measures To Mitigate BSE Risks:
Considerations for Further Action; Proposed Rule

snip...

Further, Wisconsin has over 60 mink ranches, whose main food source is also
meat from dead animals. Many mink ranchers collect and process dead
animals to feed their mink. Prohibiting dead animals from being used in
this manner may force many mink ranchers out of this multi-million dollar
industry.


https://web01.aphis.usda.gov/regpublic.nsf/168556f5aa7a82ba85256ed00044eb1f/3aa42066efdafc2487256f0a006bef00?OpenDocument

Thursday

June 5, 1997


Part II

Department of

Health and Human

Services

Food and Drug Administration

21 CFR Part 589

Substances Prohibited From Use in

Animal Food or Feed; Animal Proteins

Prohibited in Ruminant Feed; Final Rule


http://www.fda.gov/cvm/Images/6597bse.pdf

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 589

[Docket No. 2002N-0273] (formerly Docket No. 02N-0273)
RIN 0910-AF46


Substances Prohibited From Use in Animal Food or Feed

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the agency's regulations to prohibit the use of certain cattle origin
materials in the food or feed of all animals. These materials include
the following: The brains and spinal cords from cattle 30 months of age
and older, the brains and spinal cords from cattle of any age not
inspected and passed for human consumption, the entire carcass of
cattle not inspected and passed for human consumption if the brains and
spinal cords have not been removed, tallow that is derived from the
materials prohibited by this proposed rule that contains more than 0.15
percent insoluble impurities, and mechanically separated beef that is
derived from the materials prohibited by this proposed rule. These
measures will further strengthen existing safeguards designed to help
prevent the spread of bovine spongiform encephalopathy (BSE) in U.S.
cattle.

DATES: Submit written or electronic comments by December 20, 2005.
Submit written comments on the information collection provisions by
November 7, 2005.


http://www.fda.gov/OHRMS/DOCKETS/98fr/05-20196.htm

ECONOMIC IMPACTS OF _PROPOSED_

FDA REGULATORY CHANGES TO REGULATION OF ANIMAL FEEDS

DUE TO RISK OF BOVINE SPONGIFORM ENCEPHALOPATHY

FINAL REPORT

Contract No.

223-03-8500

Task Order 3

Submitted to:

Economics Staff

Office of Policy and Planning

Office of the Commissioner

Food and Drug Administration

Rockville, MD 20857

Submitted by:

Eastern Research Group, Inc.

110 Hartwell Ave.

Lexington, MA 02421

July 25, 2005


EXECUTIVE SUMMARY

SECTION ONE

FDA is considering a modification to its rules governing animal feed by supplementing or

expanding the 1997 rule restricting the feeding of mammalian protein (except for porcine and

equine protein) to ruminant animals. In the regulatory option under study in this report, FDA has

defined prohibited cattle material (PCM) and would prohibit it from use in all animal feeds.

PCM consists of the brain and spinal cord of:

• Slaughter cattle 30 months of age or older,

• All non-ambulatory disabled cattle,

• All cattle that died other than from slaughter, and

• Mechanically separated beef from cattle from which prohibited cattle materials (i.e., brain

and spinal cord) were not removed.

These materials are not to be used in animal feed. Additionally, tallow that contains any PCM is

considered PCM. All other tallow must meet purity requirements. No more than 0.15 percent

hexane-insoluble impurities can be contained in tallow used in feed under the option considered.

This study examines the impacts of this regulatory option on the affected agricultural and food

industries. In so doing, it extends previous research performed by ERG on several other

regulatory alternatives FDA is considering. In particular, ERG’s report of August 2004 examined

different versions of an extended feed ban. Those regulatory options would prohibit a larger

volume of cattle material from animal feed.

FDA’s PCM alternative will directly prohibit a small share of animal offal from production of

meat and bone meal (MBM) and tallow. The brain and spinal cord of an average slaughter cow

weighs only 1.3 lbs. Slaughterers and renderers both have or can acquire the capability to remove

such materials from the animals they process. Nevertheless, both slaughterers and renderers will

often remove a larger share of the animal offal because (1) slaughterers generally cannot

distinguish the age of an animal sufficiently early to affect processing, (2) independent renderers

might require that their slaughter clients remove the entire skull for all animals in order to be

sure that no brain materials are included in the offal they pickup, and (3) independent renderers

that pick up deads and downers1 might have to remove the entire spinal column (not just the

spinal cord) if the carcass has deteriorated, as is often the case in summer.

The eventual disposition of PCM under this regulatory structure is uncertain. Some landfills

might accept modest quantities of brain and spinal cords without further processing. More likely,

some new disposal infrastructure will need to evolve in which PCM materials are processed

through chemical digester units or rendered prior to disposal. Newly emergent commercial

entities or existing renderers might fill this gap. Because the volumes of materials generated is

not sufficiently large for efficient processing (relative to the flows for other agricultural materials

1 The term downer is used, although the animal must be humanely euthanized prior to transporting.

1-3

like renderable animal offal), disposal or rendering for disposal charges for these materials will

exceed current costs for rendering. ERG used an assumed charge of $12 per hundredweight for

disposal or rendering for disposal.

Using the assumptions and estimates of the PCM quantities withdrawn from productive use, the

overall impact of the regulatory option on slaughtering and rendering processes is modest. The

amount of material removed from the rendering stream amounts to 0.1 percent of MBM

production and less than 0.1 percent of tallow production.

ERG also estimates the costs of meeting tallow purity requirements and the costs for renderers to

add equipment and labor to remove PCM from cattle prior to processing deads and downers.

Total compliance costs are estimated at $15.9 million, as shown in Table ES-1.


FULL TEXT 45 PAGES ;

http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0273-bkg0001-44-Ref-25-.pdf

ECONOMIC IMPACTS OF _ALTERNATIVE_

CHANGES TO THE FDA REGULATION OF ANIMAL FEEDS TO

ADDRESS THE RISK OF

BOVINE SPONGIFORM ENCEPHALOPATHY

FINAL REPORT

Contract No.

223-98-8002

Task Order 12

Submitted to

Economics Staff

Office of Policy and Planning

Office of the Commissioner

Food and Drug Administration

Rockville, MD 20857

Submitted by:

Eastern Research Group, Inc.

110 Hartwell Ave.

Lexington, MA 02421

July 25, 2005


EXECUTIVE SUMMARY

FDA considered modifying its rules governing animal feed by supplementing or expanding the

1997 rule restricting the feeding of mammalian protein (except for porcine and equine protein) to

ruminant animals. As one alternative, FDA considered prohibiting the following:

• Specified risk materials (SRM),

• Mechanically separated (MS) beef,

• Materials from dead or non-ambulatory cattle or from cattle that died by means other than

slaughter at an inspected slaughter establishment, and

• Tallow containing more than 0.15 percent hexane-insoluble impurities from inclusion in

any animal feed.

This study examines the impacts of these items on the affected agricultural and food industries.


snip....


FULL TEXT 143 PAGES ;


http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0273-bkg0001-50-Ref-31.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


Executive Summary

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

Results in Brief This report evaluates elements of the interlocking safeguards in place to protect United States (U.S.) beef from Bovine Spongiform Encephalopathy, widely known as BSE or "mad cow disease." Since 1990, the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), has led a multi-agency effort to monitor and prevent BSE from entering the food supply. After discovering a BSE-positive cow in December 2003, APHIS expanded its BSE surveillance program. To further protect the food supply, USDA banned materials identified as being at risk of carrying BSE (specified risk materials (SRM)), such as central nervous system tissue. As part of this effort, USDA’s Food Safety and Inspection Service (FSIS) required beef slaughter and processing facilities to incorporate controls for handling such materials into their operational plans. Onsite FSIS inspectors also inspect cattle for clinical signs in order to prevent diseased animals from being slaughtered for human consumption. To evaluate the effectiveness of the safeguards, we assessed APHIS’ implementation of the expanded surveillance program, as well as FSIS’ controls to prevent banned SRMs from entering the food supply.

In June 2004, APHIS implemented its expanded surveillance program; participation by industry in this surveillance program is voluntary. As of May 2005, over 350,000 animals were sampled and tested for BSE. To date, two animals tested positive for BSE; one tested positive after implementation of the expanded surveillance program.

USDA made significant efforts to implement the expanded BSE surveillance program. Much needed to be done in a short period of time to establish the necessary processes, controls, infrastructure, and networks to assist in this effort. In addition, extensive outreach and coordination was undertaken with other Federal, State, and local entities, private industry, and laboratory and veterinary networks. This report provides an assessment as to the progress USDA made in expanding its surveillance effort and the effectiveness of its controls and processes. This report also discusses the limitations of its program and data in assessing the prevalence of BSE in the U.S. herd.

Surveillance Goals and Objectives

In March 2004, USDA published its plan to expand the BSE surveillance program. The plan’s goal was to collect samples from as many adult1 cattle from the high-risk population as possible in 12-18 months while ensuring that there was statistically appropriate geographical representation of the adult cattle population in the United States. Overall, USDA designed the program to define whether BSE was actually present in the U.S. cattle population and if so, to what level.

When USDA published its plan, Office of Inspector General (OIG) was examining the pre-expansion program. In anticipation of the coming changes, we reviewed the plan in order to determine if its design would allow the Department to reach statistically valid conclusions about the presence and level of BSE. Since the implementation plan had not been finalized, we provided recommendations for USDA to consider as they moved forward with implementing an expanded surveillance program. In August 2004, we released our report, Animal and Plant Health Inspection Service and Food Safety and Inspection Service, Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase I (Report No. 50601-9-KC), which discussed our observations of the challenges USDA faced in meeting its stated goals and made 19 recommendations for USDA to consider as it moved forward with implementation. Our prior report primarily focused on (1) the potential for unwarranted statistical conclusions to be drawn from the data USDA planned to collect, and (2) the challenges in identifying and testing high-risk cattle. In response to our report, APHIS agreed to disclose the limitations of the data and the assumptions made and its impact on any statistical representations regarding the prevalence of BSE in order to obviate misinterpretation.

We reviewed the specific corrective actions APHIS and FSIS agreed to take in response to prior audit recommendations during this audit. In this report, we discuss the specific areas where corrective actions were not fully effective in addressing our concerns in the following areas: obtaining representative samples, identifying and obtaining samples from the high-risk surveillance streams, and completeness and accuracy of program data.

APHIS has provided OIG unpublished drafts of its preliminary analysis, which included various statistical approaches to determining the prevalence of BSE. In general, each approach mitigates some, but not all of the limitations associated with its data and underlying assumptions in the design and implementation of its surveillance program. Some of the approaches also

1 FSIS considers bulls and cows to be mature cattle with cows ordinarily having given birth to one or more calves. FSIS defines SRMs to be present in cattle 30 months of age or older, while APHIS defines its target population for BSE sampling to be over 30 months of age. Dentition is used to estimate the age ranges of cattle. Dentition is the development of teeth and their arrangement in the mouth.

USDA/OIG-A/50601-10-KC/ Page iii

introduce new challenges because any conclusions are extremely sensitive to the accuracy of the underlying data. The accuracy of the underlying data is also critical to the development of a future maintenance surveillance program. We cannot fully assess any of the approaches being considered by APHIS since it has not finalized its analysis. In Finding 1, however, we do offer several observations for APHIS to consider as it develops its conclusions about the prevalence of BSE in the U.S. cattle population.

Inherent Limitations in Identifying and Testing High-Risk Cattle

APHIS obtained significantly more samples for testing than they originally anticipated would be needed to achieve its stated level of confidence in estimating the prevalence of BSE in the U.S. herd. Because of the voluntary nature of its program, however, we could not determine how successful APHIS was in obtaining a representative proportion of high-risk cattle for testing. Our prior report recognized the significant challenges for APHIS to obtain samples from the high-risk population because of the inherent problems with obtaining voluntary compliance and transporting carcasses for testing. APHIS took steps to obtain facilitated pathways, by entering into over 100 agreements, to collect and test brain samples for BSE. However, using USDA published data that estimates the distribution of the cattle population, as well as those that died or became nonambulatory, we could not determine whether APHIS achieved either geographical representation or representation of the desired surveillance stream (clinical suspects, fallen stock, casualty slaughter fallen stock, and routine slaughter). Findings 1 and 2 present the conditions noted that impact this evaluation.

USDA Testing Protocols and Quality Assurance Procedures

In November 2004, USDA announced that its rapid screening test produced an inconclusive BSE test result. A contract laboratory ran its rapid screening test on a brain sample collected for testing and produced three high positive reactive results. As required, the contract laboratory forwarded the inconclusive sample to APHIS’ National Veterinary Services Laboratories (NVSL) for confirmation. NVSL repeated the rapid screening test, which again produced three high positive reactive results. Following established protocol, NVSL ran its confirmatory test, an immunohistochemistry (IHC) test, which was interpreted as negative for BSE.

Faced with conflicting results between the rapid screening and IHC tests, NVSL scientists recommended additional testing to resolve the discrepancy but APHIS headquarters officials concluded that no further testing was necessary since testing protocols were followed and the confirmatory test was negative. In our discussions with APHIS officials, they justified their decision to not do additional testing because the IHC test is internationally recognized as the "gold standard" of testing. Also, they believed that

USDA/OIG-A/50601-10-KC/ Page iv

conducting additional tests would undermine confidence in USDA’s testing protocols.

OIG obtained evidence that indicated additional testing was prudent. We came to this conclusion because the rapid screening tests produced six high positive reactive results, the IHC tests conflicted, and various standard operating procedures were not followed. Also, our review of the relevant scientific literature, other countries’ protocols, and discussions with experts led us to conclude that additional confirmatory testing should be considered in the event of conflicting test results.

To maintain objectivity and independence, we requested that USDA’s Agricultural Research Service (ARS) perform the Office International des Epizooties (OIE) Scrapie-Associated Fibrils (SAF) immunoblot test. The additional testing produced positive results. To confirm, the Secretary of Agriculture requested that an internationally recognized BSE laboratory in Weybridge, England (Weybridge) perform additional testing. Weybridge conducted various tests, including their own IHC tests and three Western blot tests. The tests confirmed that the cow was infected with BSE. The Secretary immediately directed USDA scientists to work with international experts to develop new protocols that include performing dual confirmatory tests in the event of an inconclusive BSE screening test.

We attribute the failure to identify the BSE positive sample to rigid protocols, as well as the lack of adequate quality assurance controls over its testing program. Details of our concerns are discussed in Findings 3 and 4.

Controls (Firewalls) to Prevent BSE in the Food Supply

USDA instituted proactive procedures to prevent tissues and products that could possibly contain the infective agent for BSE from entering the food supply. FSIS performs inspections on cattle before slaughter (ante mortem) to observe clinical signs that may indicate a central nervous system disorder or other signs that may be associated with BSE. Such animals are condemned and prohibited from slaughter for human consumption. FSIS also identified high-risk beef tissue and products as SRMs, and banned them from the food supply. FSIS inspects slaughter processes to verify that slaughterhouses have incorporated controls for handling SRMs into their operational plans; adequate procedures must be in place for removing, segregating, and disposing of SRMs.

OIG reviewed the SRM plans of several establishments, observed FSIS inspection procedures, and evaluated the effectiveness of controls during the slaughter process. We did not identify SRMs entering the food supply. However, due to the lack of adequate records, we could not determine whether SRM procedures were followed and/or were adequate in 9 of

2 For purposes of this report, the term renderers also includes pet food manufacturers and plants that handle dead, dying, disabled, or diseased livestock.

3 9 CFR 320.5, states that every person that engages in business in or for commerce, as a meat broker, renderer, or animal food manufacturer … shall register with the Administrator [of FSIS].

12 establishments visited during the audit. There is no requirement in the United States for the age of animals to be recorded, therefore, APHIS and FSIS rely on meat establishments to determine the age of cattle slaughtered using documentation or dentition. SRM restrictions apply predominantly to cattle 30 months of age or older. FSIS periodically checks the accuracy of age determinations through dentition; however, we could not determine how often these checks are made. We found that improvements can be made in the following areas.


• FSIS approved an alternate ante mortem inspection procedure that limited the number of cattle subject to inspection. FSIS discontinued this procedure during the audit.


• FSIS does not have an information system capable of readily identifying the scope of, and trends in, noncompliance violations relating to SRMs.


• Most of the establishments reviewed did not have adequate SRM plans, and FSIS did not always identify these deficiencies.

• Several of the establishments did not comply with their SRM plans and/or maintain records to support that they follow their plans.

FSIS has addressed the specific cases of noncompliance identified during the audit. Findings 5 through 9 discuss our assessment of the effectiveness of USDA’s firewalls.

Other Program Administration Issues

FSIS and APHIS did not maintain current and comprehensive listings of renderers2 and related businesses. These entities are required to register with FSIS as a condition of engaging in business.3 As a result, should serious animal diseases be detected in the United States, USDA’s ability to quickly determine and trace the source of infections to prevent the spread of the disease could be impaired. Also, APHIS could not use the registrations to identify potential sources to mitigate geographical gaps in BSE testing. We discuss the details of this issue in Finding 11.

We also determined that an APHIS area office paid costs for sampling and carcass transportation, storage, and disposal that exceeded national cost recovery guidelines and/or that were ineligible for reimbursement. The area office entered into 10 reimbursable agreements before national office cost recovery guidelines had been issued but did not adjust the agreements afterwards although instructed to do so by the national office. Instead, the area office included the questionable costs in amounts proposed (by

USDA/OIG-A/50601-10-KC/ Page vi

third parties) in other allowable cost categories. The area office official stated he changed supporting records because he believed he should honor the prior negotiated costs. As a result, at least $1.2 million of about $11.2 million paid were unsupported program costs. Finding 12 more fully examines the unsupported costs and why they went undiscovered.

The expanded stage of USDA’s BSE surveillance program is nearing its end. Accordingly, it is vital that the conditions summarized above be considered as USDA uses the data gathered to design an effective BSE surveillance maintenance program and to report its assessment of the prevalence of BSE in the U.S. herd. In particular, APHIS must develop testing protocols which are grounded in science and flexible enough to adapt to changing circumstances. For its part, FSIS must ensure that it effectively monitors SRM handling practices to ensure they comply with Federal regulations. Implemented, these management controls will help USDA continue to effectively safeguard the U.S. beef supply for consumers.


snip....


full text 130 pages ;


http://www.usda.gov/oig/webdocs/50601-10-KC.pdf

SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2004. SPORADIC CJD CASES TRIPLED, and that is
with a human TSE surveillance system that is terrible
flawed. in 1997 cases of the _reported_ cases of cjd
were at 54, to 163 _reported_ cases in 2004. see stats
here;

p.s. please note the 47 PENDING CASES to Sept. 2005

p.s. please note the 2005 Prion D. total 120(8)
8=includes 51 type pending, 1 TYPE UNKNOWN ???

p.s. please note sporadic CJD 2002(1) 1=3 TYPE UNKNOWN???

p.s. please note 2004 prion disease (6) 6=7 TYPE
UNKNOWN???


http://www.cjdsurveillance.com/resources-casereport.html


Finally, with a NATIONWIDE mad cow feed recall going on as we speak of some 10,878.06 TONS, it would seem prudent that that any further strengthening of any rules should include making the old rules enforceable ;


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

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

May 9, 2006

April 2006 Update on Feed Enforcement Activities to Limit the Spread of BSE

To help prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the use of most mammalian protein in feeds for ruminant animals. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, here called the Ruminant Feed Ban, became effective on August 4, 1997.

This is an update on FDA enforcement activities regarding the ruminant feed ban. FDA's CVM has assembled data from the inspections that have been conducted AND whose final inspection report has been recorded in the FDA's inspection database as of April 29, 2006. As of April 29, 2006, FDA had received over 44,000 inspection reports. The majority of these inspections (around 68%) were conducted by State feed safety officials, with the remainder conducted by FDA officials.

Inspections conducted by FDA or State investigators are classified to reflect the compliance status at the time of the inspection based upon the objectionable conditions documented. These inspection conclusions are reported as Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI).

An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory sanctions are warranted in order to address the establishment's lack of compliance with the regulation. An example of an OAI inspection classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations will be promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented.

A VAI inspection classification occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance, but do warrant advisory actions to inform the establishment of findings that should be voluntarily corrected. Inspections classified with VAI violations are more technical violations of the Ruminant Feed Ban. These include provisions such as minor recordkeeping lapses and conditions involving non-ruminant feeds.

An NAI inspection classification occurs when no objectionable conditions or practices were found during the inspection or the significance of the documented objectionable conditions found does not justify further actions.
The results to date are reported here both by “segment of industry” and “in total”. NOTE – A single firm can operate as more than one firm type. As a result, the categories of the different industry segments are not mutually exclusive.

RENDERERS

These firms are the first to handle and process (i.e., render) animal proteins and to send these processed materials to feed mills and/or protein blenders for use as a feed ingredient.

Number of active firms whose initial inspection has been reported to FDA – 266


Number of active firms handling materials prohibited from use in ruminant feed – 175 (66% of those active firms inspected)


Of the 175 active firms handling prohibited materials, their most recent inspection revealed that:


2 firms (1.1%) were classified as OAI


4 firms (2.3%) were classified as VAI

LICENSED FEED MILLS

FDA licenses these feed mills to produce medicated feed products. The license is required to manufacture and distribute feed using certain potent drug products, usually those requiring some pre-slaughter withdrawal time. This licensing has nothing to do with handling prohibited materials under the feed ban regulation. A medicated feed license from FDA is not required to handle materials prohibited under the Ruminant Feed Ban.

Number of active firms whose initial inspection has been reported to FDA – 1,092


Number of active firms handling materials prohibited from use in ruminant feed – 430 (39% of those active firms inspected)


Of the 430 active firms handling prohibited materials, their most recent inspection revealed that:


0 firms (0%) were classified as OAI


5 firms (1.2%) were classified as VAI

FEED MILLS NOT LICENSED BY FDA

These feed mills are not licensed by the FDA to produce medicated feeds.

Number of active firms whose initial inspection has been reported to FDA – 5,128


Number of active firms handling materials prohibited from use in ruminant feed – 2,176 (42% of those active firms inspected)

Of the 2,176 active firms handling prohibited materials, their most recent inspection revealed that:


0 firms (0%) were classified as OAI


36 firms (1.7%) were classified as VAI

PROTEIN BLENDERS

These firms blend rendered animal protein for the purpose of producing quality feed ingredients that will be used by feed mills.

Number of active firms whose initial inspection has been reported to FDA -- 340


Number of active firms handling materials prohibited from use in ruminant feed – 162 (48% of those active firms inspected)


Of the 162 active firms handling prohibited materials, their most recent inspection revealed that:


0 firms (0%) were classified as OAI


3 firms (1.9%) were classified as VAI

RENDERERS, FEED MILLS, AND PROTEIN BLENDERS

This category includes only those firms that actually use prohibited material to manufacture, process, or blend animal feed or feed ingredients.

Number of active renderers, feed mills, and protein blenders whose initial inspection has been reported to FDA – 6,558


Number of active renderers, feed mills, and protein blenders processing with prohibited materials – 491 (7.5%

Of the 491 of active renderers, feed mills, and protein blenders processing with prohibited materials, their most recent inspection revealed that:


2 firms (0.4%) were classified as OAI


19 firms (3.9%) were classified as VAI

OTHER FIRMS INSPECTED

Examples of such firms include ruminant feeders, on-farm mixers, pet food manufacturers, animal feed salvagers, distributors, retailers, and animal feed transporters.

Number of active firms whose initial inspection has been reported to FDA – 14,627


Number of active firms handling materials prohibited from use in ruminant feed – 4,314 (29% of those active firms inspected)


Of the 4,314 active firms handling prohibited materials, their most recent inspection revealed that:


3 firms (0.1%) were classified as OAI


117 firms (2.7%) were classified as VAI

TOTAL FIRMS

Note that a single firm can be reported under more than one firm category; therefore, the summation of the individual OAI/VAI firm categories will be more than the actual total number of OAI/VAI firms, as presented below.

Number of active firms whose initial inspection has been reported to FDA – 17,454


Number of active firms handling materials prohibited from use in ruminant feed – 5,103 (29% of those active firms inspected)


Of the 5,103 active firms handling prohibited materials, their most recent inspection revealed that:


5 firms (0.1%) were classified as OAI


126 firms (2.5%) were classified as VAI


--------------------------------------------------------------------------------

Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm


http://www.fda.gov/cvm/CVM_Updates/BSE0506.htm

Subject: 15,323 TONS OF POTENTIAL TAINTED TSE RUMINANT PROTEIN WITHOUT MAD COW FEED WARNING IN CIRCULATION 4 STATES
Date: November 10, 2005 at 2:05 pm PST


PRODUCT
a) Bulk nonmedicated custom swine and poultry feeds,
Recall # V-006-6;
b) Bulk medicated swine and poultry feeds, Recall # V-007-6
CODE
N/A
RECALLING FIRM/MANUFACTURER
Gold Eagle Cooperative, Goldfield, IA, by telephone or visit beginning August 30, 2005. Firm initiated recall is complete.
REASON
Swine and poultry feeds which may contain prohibited material are not labeled with the warning statement not to feed to cattle or other ruminants.
VOLUME OF PRODUCT IN COMMERCE
Approx. 15,323.68 tons of nonmedicated and medicated feed
DISTRIBUTION
IA, GA, MD, and MN

______________________________


http://www.fda.gov/bbs/topics/enforce/2005/ENF00925.html

FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT


Today the Food and Drug Administration announced the results of tests taken on feed used at a Texas feedlot that was suspected of containing meat and bone meal from other domestic cattle -- a violation of FDA's 1997 prohibition on using ruminant material in feed for other ruminants. Results indicate that a very low level of prohibited material was found in the feed fed to cattle.

FDA has determined that each animal could have consumed, at most and in total, five-and-one-half grams - approximately a quarter ounce -- of prohibited material. These animals weigh approximately 600 pounds.

It is important to note that the prohibited material was domestic in origin (therefore not likely to contain infected material because there is no evidence of BSE in U.S. cattle), fed at a very low level, and fed only once. The potential risk of BSE to such cattle is therefore exceedingly low, even if the feed were contaminated.

According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy Commissioner, "The challenge to regulators and industry is to keep this disease out of the United States. One important defense is to prohibit the use of any ruminant animal materials in feed for other ruminant animals. Combined with other steps, like U.S. Department of Agriculture's (USDA) ban on the importation of live ruminant animals from affected countries, these steps represent a series of protections, to keep American cattle free of BSE."

Despite this negligible risk, Purina Mills, Inc., is nonetheless announcing that it is voluntarily purchasing all 1,222 of the animals held in Texas and mistakenly fed the animal feed containing the prohibited material. Therefore, meat from those animals will not enter the human food supply. FDA believes any cattle that did not consume feed containing the prohibited material are unaffected by this incident, and should be handled in the beef supply clearance process as usual. ...

snip...


http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html


WE know now, and we knew decades ago, that 5.5 grams of suspect feed in TEXAS was enough to kill 100 cows.


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


2

6. It also appears to me that Mr Bradley’s answer (that it would take less than say 100

grams) was probably given with the benefit of hindsight; particularly if one

considers that later in the same answer Mr Bradley expresses his surprise that it

could take as little of 1 gram of brain to cause BSE by the oral route within the

same species. This information did not become available until the "attack rate"

experiment had been completed in 1995/96. This was a titration experiment

designed to ascertain the infective dose. A range of dosages was used to ensure

that the actual result was within both a lower and an upper limit within the study

and the designing scientists would not have expected all the dose levels to trigger

infection. The dose ranges chosen by the most informed scientists at that time

ranged from 1 gram to three times one hundred grams. It is clear that the designing

scientists must have also 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/s147f.pdf


Re: BSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts

[BBC radio 4 FARM news]


http://www.maddeer.org/audio/BBC4farmingtoday2_1_03.ram

http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm


2) Infectious dose:

To cattle: 1 gram of infected brain material (by oral ingestion)


http://www.inspection.gc.ca/english/sci/bio/bseesbe.shtml

Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518


[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle

03-025IFA
03-025IFA-2
Terry S. Singeltary


Page 1 of 17

From: Terry S. Singeltary Sr. [flounder9@verizon.net]

Sent: Thursday, September 08, 2005 6:17 PM

To: fsis.regulationscomments@fsis.usda.gov

Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements

for the Disposition of Non-Ambulatory Disabled Cattle

Greetings FSIS,

I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and

Requirements for the Disposition of Non-Ambulatory Disabled Cattle

THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle

Broken bones and such may be the first signs of a sub clinical BSE/TSE Non-Ambulatory Disabled Cattle ;

SUB CLINICAL PRION INFECTION

MRC-43-00

Issued: Monday, 28 August 2000

NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCH

FINDINGS RELEVANT TO CJD AND BSE


Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518

9/13/2005

http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf


========================================================

========================================================

OLD TSS SUBMISSIONS;


Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)

https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument

Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA


https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed


Docket Management Docket: 02N-0273 - Substances Prohibited From Use in

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html

PART 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html

PDF]Freas, William TSS SUBMISSION

File Format: PDF/Adobe Acrobat -

Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary

Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...


http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf


Asante/Collinge et al, that BSE transmission to the 129-methionine

genotype can lead to an alternate phenotype that is indistinguishable

from type 2 PrPSc, the commonest _sporadic_ CJD;


http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm

Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice
in Manufacturing, Packing, or Holding Dietary Ingredients a
Comment Number: EC -2
Accepted - Volume 7

http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm

[PDF] Appendices to PL107-9 Inter-agency Working Group Final Report 1-1
File Format: PDF/Adobe Acrobat - View as HTML
Agent, Weapons of Mass Destruction Operations Unit Federal Bureau of
those who provided comments in response to Docket No. ...
Meager 8/18/01 Terry S. Singeltary Sr ...


http://www.aphis.usda.gov/lpa/pubs/pubs/PL107-9_Appen.pdf

Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt

# Docket No: 02-088-1 RE-Agricultural Bioterrorism Protection Act of
2002; [TSS SUBMISSION ON POTENTIAL FOR BSE/TSE & FMD 'SUITCASE BOMBS'] -
TSS 1/27/03 (0)

Docket Management

Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC-254 [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm

Dockets Entered On October 2, 2003 Table of Contents, Docket #,
Title, 1978N-0301,

OTC External Analgesic Drug Products, ... EMC 7, Terry S. Singeltary Sr.
Vol #: 1, ...

http://www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm

Daily Dockets Entered on 02/05/03

DOCKETS ENTERED on 2/5/03. ... EMC 4 Terry S. Singeltary Sr. Vol#: 2.
... Vol#: 1.

03N-0009 Federal Preemption of State & Local Medical Device Requireme. ...


http://www.fda.gov/ohrms/dockets/dailys/03/Feb03/020503/020503.htm

Docket Management

Docket: 02N-0370 - Neurological Devices; Classification of Human Dura Mater

Comment Number: EC -1

Accepted - Volume 1


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be11.html


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004bdfe.html


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004bdfc.html

Daily Dockets - 04/10/03

... 00D-1662 Use of Xenotransplantation Products in Humans.
EMC 98 Terry S. Singeltary Sr. Vol#: 3. 01F ...
http://www.fda.gov/ohrms/dockets/dailys/03/Apr03/041003/041003.htm - 05-20-2003
- Cached


2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed

EMC 1
Terry S. Singeltary Sr.
Vol #:
1

http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm

2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed


EMC 7
Terry S. Singeltary Sr.
Vol #:
1

2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed


EMC 7
Terry S. Singeltary Sr.
Vol #:
1


http://www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm


01N-0423 Substances Prohibited from use in animal food/Feed Ruminant

APE 5 National Renderers Association, Inc. Vol#: 2

APE 6 Animal Protein Producers Industry Vol#: 2

APE 7 Darling International Inc. Vol#: 2

EMC 1 Terry S. Singeltary Sr. Vol#: 3

http://www.fda.gov/ohrms/dockets/dailys/01/Oct01/101501/101501.htm


Send Post-Publication Peer Review to journal:


Re: RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob

disease in the United States


Email Terry S. Singeltary:


flounder@wt.net


I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to

comment on the CDC's attempts to monitor the occurrence of emerging

forms of CJD. Asante, Collinge et al [1] have reported that BSE

transmission to the 129-methionine genotype can lead to an alternate

phenotype that is indistinguishable from type 2 PrPSc, the commonest

sporadic CJD. However, CJD and all human TSEs are not reportable

nationally. CJD and all human TSEs must be made reportable in every

state and internationally. I hope that the CDC does not continue to

expect us to still believe that the 85%+ of all CJD cases which are

sporadic are all spontaneous, without route/source. We have many TSEs in

the USA in both animal and man. CWD in deer/elk is spreading rapidly and

CWD does transmit to mink, ferret, cattle, and squirrel monkey by

intracerebral inoculation. With the known incubation periods in other

TSEs, oral transmission studies of CWD may take much longer. Every

victim/family of CJD/TSEs should be asked about route and source of this

agent. To prolong this will only spread the agent and needlessly expose

others. In light of the findings of Asante and Collinge et al, there

should be drastic measures to safeguard the medical and surgical arena

from sporadic CJDs and all human TSEs. I only ponder how many sporadic

CJDs in the USA are type 2 PrPSc?


http://www.neurology.org/cgi/eletters/60/2/176#535

LANCET INFECTIOUS DISEASE JOURNAL


Volume 3, Number 8 01 August 2003


Newsdesk


Tracking spongiform encephalopathies in North America


Xavier Bosch

My name is Terry S Singeltary Sr, and I live in Bacliff, Texas. I lost

my mom to hvCJD (Heidenhain variant CJD) and have been searching for

answers ever since. What I have found is that we have not been told the

truth. CWD in deer and elk is a small portion of a much bigger problem.


49-year-old Singeltary is one of a number of people who have remained

largely unsatisfied after being told that a close relative died from a

rapidly progressive dementia compatible with spontaneous

Creutzfeldt-Jakob disease (CJD). So he decided to gather hundreds of

documents on transmissible spongiform encephalopathies (TSE) and

realised that if Britons could get variant CJD from bovine spongiform

encephalopathy (BSE), Americans might get a similar disorder from

chronic wasting disease (CWD)the relative of mad cow disease seen among

deer and elk in the USA. Although his feverish search did not lead him

to the smoking gun linking CWD to a similar disease in North American

people, it did uncover a largely disappointing situation.


Singeltary was greatly demoralised at the few attempts to monitor the

occurrence of CJD and CWD in the USA. Only a few states have made CJD

reportable. Human and animal TSEs should be reportable nationwide and

internationally, he complained in a letter to the Journal of the

American Medical Association (JAMA 2003; 285: 733). I hope that the CDC

does not continue to expect us to still believe that the 85% plus of all

CJD cases which are sporadic are all spontaneous, without route or source.


Until recently, CWD was thought to be confined to the wild in a small

region in Colorado. But since early 2002, it has been reported in other

areas, including Wisconsin, South Dakota, and the Canadian province of

Saskatchewan. Indeed, the occurrence of CWD in states that were not

endemic previously increased concern about a widespread outbreak and

possible transmission to people and cattle.


To date, experimental studies have proven that the CWD agent can be

transmitted to cattle by intracerebral inoculation and that it can cross

the mucous membranes of the digestive tract to initiate infection in

lymphoid tissue before invasion of the central nervous system. Yet the

plausibility of CWD spreading to people has remained elusive.


Part of the problem seems to stem from the US surveillance system. CJD

is only reported in those areas known to be endemic foci of CWD.

Moreover, US authorities have been criticised for not having performed

enough prionic tests in farm deer and elk.


Although in November last year the US Food and Drug Administration

issued a directive to state public-health and agriculture officials

prohibiting material from CWD-positive animals from being used as an

ingredient in feed for any animal species, epidemiological control and

research in the USA has been quite different from the situation in the

UK and Europe regarding BSE.


Getting data on TSEs in the USA from the government is like pulling

teeth, Singeltary argues. You get it when they want you to have it,

and only what they want you to have.


Norman Foster, director of the Cognitive Disorders Clinic at the

University of Michigan (Ann Arbor, MI, USA), says that current

surveillance of prion disease in people in the USA is inadequate to

detect whether CWD is occurring in human beings; adding that, the

cases that we know about are reassuring, because they do not suggest the

appearance of a new variant of CJD in the USA or atypical features in

patients that might be exposed to CWD. However, until we establish a

system that identifies and analyses a high proportion of suspected prion

disease cases we will not know for sure. The USA should develop a

system modelled on that established in the UK, he points out.


Ali Samii, a neurologist at Seattle VA Medical Center who recently

reported the cases of three hunterstwo of whom were friendswho died

from pathologically confirmed CJD, says that at present there are

insufficient data to claim transmission of CWD into humans; adding that

[only] by asking [the questions of venison consumption and deer/elk

hunting] in every case can we collect suspect cases and look into the

plausibility of transmission further. Samii argues that by making both

doctors and hunters more aware of the possibility of prions spreading

through eating venison, doctors treating hunters with dementia can

consider a possible prion disease, and doctors treating CJD patients

will know to ask whether they ate venison.


CDC spokesman Ermias Belay says that the CDC will not be investigating

the [Samii] cases because there is no evidence that the men ate

CWD-infected meat. He notes that although the likelihood of CWD

jumping the species barrier to infect humans cannot be ruled out 100%

and that [we] cannot be 100% sure that CWD does not exist in humans&

the data seeking evidence of CWD transmission to humans have been very

limited.

http://infection.thelancet.com/journal/journal.isa


he complained in a letter to the Journal of the American Medical


Association (JAMA 2003; 285: 733). I hope that the CDC does not

continue to expect us to still believe that the 85% plus of all CJD

cases which are sporadic are all spontaneous, without route or source.<<<


actually, that quote was from a more recent article in the Journal of

Neurology (see below), not the JAMA article...


Full Text

Diagnosis and Reporting of Creutzfeldt-Jakob Disease

Singeltary, Sr et al. JAMA.2001; 285: 733-734.


http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=dignosing+and+reporting+creutzfeldt+jakob+disease&searchid=1048865596978_1528&stored_search=&FIRSTINDEX=0&journalcode=jama

BRITISH MEDICAL JOURNAL


SOMETHING TO CHEW ON


BMJ


http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2

BMJ


http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1

THE PATHOLOGICAL PROTEIN

BY Philip Yam

Yam Philip Yam News Editor Scientific American www.sciam.com
http://www.thepathologicalprotein.com/

IN light of Asante/Collinge et al findings that BSE transmission to the
129-methionine genotype can lead to an alternate phenotype that is
indistinguishable from type 2 PrPSc, the commonest _sporadic_ CJD;

-------- Original Message -------- Subject: re-BSE prions propagate as

either variant CJD-like or sporadic CJD Date: Thu, 28 Nov 2002 10:23:43

-0000 From: "Asante, Emmanuel A" To:
"'flounder@wt.net'"

Dear Terry,

I have been asked by Professor Collinge to respond to your request. I am

a Senior Scientist in the MRC Prion Unit and the lead author on the

paper. I have attached a pdf copy of the paper for your attention. Thank

you for your interest in the paper.

In respect of your first question, the simple answer is, yes. As you

will find in the paper, we have managed to associate the alternate

phenotype to type 2 PrPSc, the commonest sporadic CJD.

It is too early to be able to claim any further sub-classification in

respect of Heidenhain variant CJD or Vicky Rimmer's version. It will

take further studies, which are on-going, to establish if there are

sub-types to our initial finding which we are now reporting. The main

point of the paper is that, as well as leading to the expected new

variant CJD phenotype, BSE transmission to the 129-methionine genotype

can lead to an alternate phenotype which is indistinguishable from type

2 PrPSc.


I hope reading the paper will enlighten you more on the subject. If I

can be of any further assistance please to not hesitate to ask. Best wishes.


Emmanuel Asante

<> ____________________________________

Dr. Emmanuel A Asante MRC Prion Unit & Neurogenetics Dept. Imperial

College School of Medicine (St. Mary's) Norfolk Place, LONDON W2 1PG

Tel: +44 (0)20 7594 3794 Fax: +44 (0)20 7706 3272 email:

e.asante@ic.ac.uk (until 9/12/02)

New e-mail: e.asante@prion.ucl.ac.uk (active from now)

____________________________________

snip...

full text ;

http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm

CJD WATCH

http://www.fortunecity.com/healthclub/cpr/349/part1cjd.htm


CJD WATCH MESSAGE BOARD

http://disc.server.com/Indices/167318.html


TSS




Follow Ups:



Post a Followup

Name:
E-mail: (optional)
Subject:

Comments:

Optional Link URL:
Link Title:
Optional Image URL: