December 13,2005
FDA Proposal to Amend Feed Rule
Page 5 of 5
or disabled cattle to offset the labor and disposal costs associated with the rule.
Smaller or less conscilentious producers may elect to improperly dispose of dead cattle
to avoid pickup fees and create further environmental and human and animal health
issues, in addition to those imposed by placing raw animal materials in a landfill.
Consumer groups, animal rights activists and special interest groups will be very vocal
in their support of further regulation. It is up to the FDA to realize that we DO have the
safest and best beef and milk in the world, and that no further action is necessary.
I would like to summarize this letter by saying "ENOUGH IS ENOUGH" and it is not too
late to tell Brussels, OIE, and the EU to "KISS OUR ASS".
Very Truly Yours,
BAKER COMMODITIES INC.
C/bresident
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000421-01-vol36.pdf
C 426 Fayetteville animal Clinic, P.C. Vol #: 36
HOLLY ANDREWS, D.V.M. W. H. KIDD, D.V.M.
MARGIE CARTER, D.V.M. STACY SMITH, D.V.M.
MARY CHORNEY, D.V.M. NAT WALKER, D.V.M.
FAYETTEVILLE ANIlMAL CLINIC, I-X'.
FAYETTEVILLE, TENNESSEE 37334
TELEPHONE (93 1) 433- 1202
t)?i?! 5 DECl5 A9:49
Dear Sir/Madam,
Comment on Docket No. 2002N-0273 Proposed Rule To amend BSE Feed Ban
Our veterinary practice is located in a rural area of southern middle Tennessee. This
area has a large agricultural livestock business. The county we are located in (Lincoln
County) is number one in the state of Tennessee in terms of beef cattle numbers with
approximately 70,000 head. Currently our dead animals are removed by a rendering
company (Griffin Industries). The proposed rule to amend the BSE feed ban, if enacted,
would effectively stop dead animal removal by the rendering company in our county as
well as surrounding counties. It would be impossible to economically and practically
remove the brain and spinal cord from all the dead cattle so the companies would stop
picking them up.
The only practical alternative would be burial. Non compliance with proper burial, or
no burial at all, would be a big problem. On numerous farms in our county soil is not
deep enough to bury an animal correctly. Our county is located in a geographic area of
rolling hills with numerous limestone rock outcroppings and caves with water running
into the caves. There is no county wide public water system that serves everyone. A
large percentage of our population still relies on wells and springs for their drinking
water. Not having a rsendering service pick up dead animals would lead to ground and
surface water contamination, a danger to livestock and human health, and causing odor
and aesthetic problems throughout the county. It would also result in increased cost to
the farmers and loss of otherwise useable cattle by-products.
In addition, the current ruminant to ruminant feed ban prevents possible spread of
BSE in cattle. Other animals that might consume cattle by-products are not in the human
food chain and would not pose a risk to human health.
The USDA surveillance program has demonstrated that the United States does not
have a problem with BSE. The miniscule risk of BSE does not warrant all the increased
risk to human and environmental health that the above rule would create.
We would like to respectfully request that the above rule be withdrawn from
consideration.
Sincerely,
Fayetteville Animal Clinic
Holly Andrews, D.V.M.
Mary Chorney, D.V.M.
Margaret Carter, D.V.M.
William H. Kidd, D.V.
Stacy Smith, D.V.M.
Nat Walker, D.V.M.
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000426-01-vol36.pdf
C 413 Farmers Union Industries, LLC Vol #: 36
0
IJJ 002,'00~.
0 Phone: 507-537-2935
Fax: 507-637-5499
Farmers Union Industries, LLC I.
590 west Park Roh l :'A B&3,9
. I.
l h&Wood Falls, Minnesota 56283-0379
Dee 14,2005
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, 'Room 1061
Rochiie, Maryland 20852.
Re: Dtxket Na 2002~'0273, .krbstunces Rohibited From use in Artimal Food
OrFeed
To Whom It May Concern:
This letter is in reference to FDA's Docket No. 2002N-0273, the agency's proposed rule
and the invitation to comment on substances prohibited from use in animal food or teed.
Central Bi-Products; is the largest rendering company in the State of Minnesota with
plants located in Redwood Falls and Long Prairie. We provide rendering suvice to three
cow slaughtering plants, killing animals over 30 months of age, over a thousand locker
plants that are not IJSDA inspected, and farm pick-up of mortalities. The FDA proposed
rule 2 1 CFR Part 589 will create an extreme hardship for these customers and Central Bi-
Products.
COW Slaughter plants will have 3,500,OOO pounds of brains and spinal cords that we will
not allow into our rendering plants based upon current understanding of the proposed rule
and facility compliance. This m&al will most likely go to land fills.
Locker plants in oulr service area will have over 20 million pounds of material that could
potentialIy be land ffilled.
On Gum mortalities create the largest problem, Central B&Products provides removal
service to Minnesota, Eastern South Dakota and SE North Dakota. If the rule becomes
law, Central B&Products will be forced to discontinue dead stock pick-up of all bovine
animals leaving the farmers and ranchers in excess of 35,OOO,OOO pound of animals that
will be disposed of by land fills, burial, dumping into creeks and rivers, or what ever
means can be used to make these animals disappear. In addition this loss of material and
revenue to contract haulers would most likely eliminate economic pick-up for porcine
mortalities as well. Our analysis shows that the only route that would continue to exist
would be those seAng commercial f&lots. This would result in the elimination of 24
contract hauler positions and present another financial burden to the family farm. Central
Bi-Products would 'become an independent packer/renderer with this law.
oak ox!! CY\3
12/14/2005 14:47 FAX
The states sewed by our mmpany would lose the important disease control and
monitoring service ithat we have provided to state and federal agencies over the past
twenty-six years. We have served USDA and state veterinary seryices with disease
reporting and control, including the service our cxxnpany provided BS part of the BSE
suweilhnce program.
The USDA has tested 530,000 animals for BSE with only one positive case. We do not
have a health concern Corn BSB. Firewalls are in place to assure that ruminam byproducts
are not feed back to ruminants. The FDA rule is not needed to protect our beef
supply, moreover it will create a large economic loss to the industry and create a situation
with dead rotting araimals and animal parts be disposed of in unsafe ways. We could
potentially be neat@ a breeding ground for many other diseases that arc more dc&ly
than BSE. Furthermore, if we do have a positive BSE animal that is burled or allowed to
rot and be scavenged be wild animals do we not provide a path &r unwanted spread of
the priori. What will fiture generations think of the FDA if we allow this to happen.
We disagree with tbe conclusion that i%rther acrion pvsed in the rule is necessary,
urge the FDA to seriously consider comments from the National Renderers Association
(NRA)andthe2005R d en ering Industry Study by In&ma Economics, and urge the
agency to do indeptb economic and environmental impact studies, based on current and
representative data, before formalizing the proposed rule.
We continue to support scientifically based animal feeding regulations to restrict the use
of certain animal proteins derived tirn mammalian tissues used in ruminant feeds. We
agree that animal feed regulations need to be reviewed from time-to-time if new risks are
identified or new, relevant scim is brought to light. However, we agree with the NRA
analysis of the facts and believe FDA's preliminary conclusion to remove cattle brains
and spinal cord and rendered dead animals from all animal feed is not warranted and this
action aimed at removing a very minute risk from BSE will increase risks from other
diseases, cause environmental degradation, and cost much more than can be justified.
The 1997 feed rule iis working and compliance is extremely high. The USDA enhanced
surveillance testing program found only one indigenous cow tested positive for BSE out
of more than 534,879 surveillance samples Corn high risk groups over the past 15 months
showing the incidence of BSE in the U.S. to be near zero. The National Cattleman's
Beef Association esrtimates an infection rate in the U.S. of one in more than 18 million
caWcle over 30 months of ag*for all practical purposes it is statistically zero.
Applying the wrne rules as recommended in Europe is nonsense. The incidence in the
U.S. is at least 500 fold lower than in the EU. The U.S. instituted preventive masures
long before Burope, and the early action assured the infection was never established here.
It is also worth noting that the rendering industry in Europe is heavily subsidized so that
prohibited materials are picked up and processed avoiding a massive disposal problem.
We agree witb NRA,'s statement tbt the feasibility of removing brains and spinal cords
from dead stmk is very low except under the best conditions of weather, climate, distance
betareen production and rendering locations, age, size, and condition of cattle, works
12/14/2005 14:4R FAX
skill, and equipment and technology, Renderers will be forced to charge higher
collection f&es to cover the increaSed costs of material disposal, professing, and lost
product revenues olr end the practice of collecting dead urttle altogether. The magnitude
of the disposal prohlem the proposed rule would cause is much larger than FDA
estimates.
FDA describes the primary benefit of the proposed rule as "elimination of the vast
majority of the risk of spreading BSE to other cattle fiom intentional or unintentional use
of non-ruminant feed for ruminants or cross-contamination of ruminant feed with nonruminant
feed or ingredients intend4 fbr non-ruminant f&." The risks eliminated by
the proposal are likely much smaller than the fiture risks of burying carcasses and
disease agents on the fivm at best, and more inappropriate methods at worse.
If the FDA requires dedicated flxilities, equipment, storage, and transportation equipment
to handle prohibited cattle materials, it may not be economically feasible for rendenxs to
continue prooessing such material. It would be more likely for this material to be
deposited in landfills, resulting in increasexl environmental exposure because of the high
biological load of this material in its unpr~sed state.
In summary, we believe this action aimed at removing a very minute risk corn BSE will
increase risks &om other diseases, cause environmental degradation, and cost much more
than can be justified-fbr renderers, producers, procus~ n, and society. We urge the
FDA to take no fbrther action to add restrictions to the 1997 feed rule.
Resm y submitted by:
&-
Charles Neece
Director: Research and Development
Farmers Union Industries
Central Bi-Products, div.
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000413-01-vol36.pdf
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
Dockets Entered On December 22, 2005
2002N-0273 Animal Proteins Prohibited in Ruminant Feed
C 454 United States Animal Health Association (USAHA) Vol #: 39
C 455 Australian Government Vol #: 39
C 456 R. Moore et al. Vol #: 39
C 457 Kentucky Farm Bureau Federation Vol #: 39
C 458 Baker Commodities, Inc. Vol #: 39
C 459 Farmers Union Industries, LLC Vol #: 39
C 460 B. Smith Vol #: 39
C 461 National Renderers Association, Inc. (NRA) Vol #: 39
EC 197 PARAMORE MEAT PROCESSING Vol #: 34
EC 198 Center for Food Safety Vol #: 34
EC 199 Pennsylvania Department of Agriculture Vol #: 34
EC 200 Tennessee Department of Agriculture, animal health Vol #: 34
EC 201 APC, Inc. Vol #: 34
EC 202 N. Amer. Spray Dried Blood Vol #: 34
EC 203 McDonald's Restaurants Corporation Vol #: 34
EC 204 Mrs. Bonnie Warner Vol #: 34
EC 205 McDonald's Restaurants Corp Vol #: 34
EC 206 Dr. Farris Beasley Vol #: 34
EC 207 Kentucky Department of Agriculture Vol #: 34
EC 208 American Farm Bureau Federation Vol #: 34
EC 209 VA Department of Environmental Quality Vol #: 34
EC 210 The National Assn of State Depts of Agriculture Vol #: 34
EC 211 Food Vol #: 34
EC 212 Mrs. melissa cave Vol #: 34
EC 213 Tennessee Farm Bureau Federation Vol #: 34
EC 214 Marshall County Farm Bureau Vol #: 34
EC 215 Giles County Farm Bureau Vol #: 34
EC 216 South Dakota Animal Industry Board Vol #: 34
EC 217 Texas and Southwestern Cattle Raisers Association Vol #: 34
EC 218 Dr. John Eckman Vol #: 34
EC 219 Clemson University Vol #: 34
EC 220 American Meat Institute Vol #: 34
EC 221 Carolina By Products Vol #: 34
EMC 124 J. Jones Vol #: 14
EMC 125 L. Cunningham Vol #: 14
EMC 126 National Grain and Feed Association (NGFA) Vol #: 14
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122205/122205.htm
2002N-0273 Animal Proteins Prohibited in Ruminant Feed
C 462 Darling International, Inc. (Darling) Vol #: 39
C 463 World Renderers Organization Vol #: 39
C 464 Food Animal Concerns Trust (FACT) Vol #: 39
C 465 Georgia Department of Agriculture Vol #: 39
C 466 National Grain and Feed Association (NGFA) Vol #: 39
C 467 Georgia Department of Agriculture Vol #: 39
C 468 M. Wise Vol #: 39
C 469 R. Kidd Vol #: 39
C 470 J. Kidd Vol #: 39
C 471 Eligible Vol #: 40
C 472 University of California Vol #: 40
C 473 Honorable Randy Neugebauer Vol #: 40
C 474 R. Martin Vol #: 40
C 475 A. Allebach Vol #: 40
C 476 Georgia Department of Agriculture Vol #: 40
C 477 Northwest Meat Processors Association Vol #: 40
C 478 Maryland Department of Agriculture Vol #: 40
C 479 B. Harris Vol #: 40
C 480 Association of American Feed Control Officials, Inc. (AAFCO) Vol #: 40
C 481 R. Biven et al. Vol #: 40
C 482 American Feed Industry Association (AFIA) Vol #: 40
C 483 Wisconsin Department of Agriculture, Trade and Consumer Protection (DATCP) Vol #: 40
C 484 County Mayor of Coffee County Vol #: 40
C 485 California Grain and Feed Association (CGFA) Vol #: 40
C 486 Consumers Union Vol #: 40
C 487 Washington State Department of Agriculture (WSDA) Vol #: 40
C 488 Griffin Industries, Inc. Vol #: 40
C 489 National Meat Association (NMA) Vol #: 40
C 490 Paul W. Brown, MD et al. Vol #: 40
C 491 C. Bremmer Vol #: 40
C 492 Food Safety and Inspection Service (FSIS) Vol #: 40
C 493 A. Bobo Vol #: 40
C 494 Kentucky Dairy Development Council (KDDC) Vol #: 40
C 495 Eligible Vol #: 40
C 496 J. Chorest Vol #: 40
C 497 Baker Commodities, Inc. Vol #: 40
C 498 Consolidated Blenders, Inc. (CBI) Vol #: 40
C 499 M. Fisher Vol #: 40
C 500 National Cattlemen's Beef Association (NCBA) Vol #: 40
C 501 Center for Food Safety (CFS) Vol #: 40
C 502 J. Longo Vol #: 40
LET 1 Honorable John E. Peterson Vol #: 40
LET 2 Honorable John E. Peterson Vol #: 40
LET 3 Honorable Jim Bunning Vol #: 40
SUP 1 Article on Spongiform Diseases Vol #: 40
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122305/122305.htm
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122005/122005.htm#02N0273
2002N-0273 Animal Proteins Prohibited in Ruminant Feed EC 178 Ms. Erin Riddle Vol #: 34 EC 179 Christian County KY Fiscal Court Vol #: 34 EC 180 Mrs. JOANNE BURKE Vol #: 34 EC 181 Ms. Kelli Burke Vol #: 34 EC 182 Miss. Julianne Pach Vol #: 34 EC 183 Ms. Tammy Maes Vol #: 34 EC 184 Mr. Alan Albright Vol #: 34 EC 185 Ms. Stacy Rullman Vol #: 34 EC 186 Valley Proteins, Inc Vol #: 34 EC 187 Valley Proteins, Inc Vol #: 34 EC 188 Christian County, KY Fiscal Court Vol #: 34 EC 189 Anamax Vol #: 34 EC 190 Mr. Pablo Lau Jr. Vol #: 34 EC 191 Dairy Farmers of America, Inc. Vol #: 34 EC 192 Strickland Enterprises Vol #: 34 EC 193 Mrs. Mary Max Vol #: 34 EC 194 Mr. RANDY JONES Vol #: 34 EC 195 Mr. Daniel Cooper Vol #: 34 EC 196 Dr. Loretta Pesteanu Vol #: 34
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/121905/121905.htm#02N0273
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122705/122705.htm
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122805/122805.htm
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122905/122905.htm
2002N-0273 Animal Proteins Prohibited in Ruminant Feed
C 384 E. Herndon, Sr. Vol #: 35
C 385 M. Martin Vol #: 35
C 386 M. Cramer Vol #: 35
C 387 M. Miller Vol #: 35
C 388 H and J Howbaher Vol #: 35
C 389 P. Olsen Vol #: 35
C 390 J. Manion Vol #: 35
C 391 R. Travis Vol #: 35
C 392 C. Cheeks Vol #: 35
C 393 R. Gilbo Vol #: 35
C 394 G. Russell Vol #: 35
C 395 J. Schnobrich Vol #: 35
C 396 D. Teeter Vol #: 35
C 397 J. Shand Vol #: 35
C 398 M. Yohe Vol #: 35
C 399 S. Twitchell Vol #: 35
C 400 L. Taylor Vol #: 35
C 401 T. Amato Vol #: 35
C 402 C. Schultz Vol #: 35
C 403 Gibson County Courthouse Vol #: 35
C 404 D. Diaz Vol #: 35
C 405 E. Burkholder Vol #: 35
C 406 J. Harker Vol #: 36
C 407 R. Williams Vol #: 36
C 408 S. Reneau Vol #: 36
C 409 Giles Couny, Tennessee Vol #: 36
C 410 J. Tyler Vol #: 36
C 411 M. Lukasiewicz Vol #: 36
C 412 Honorable Randy Neugebauer Vol #: 36
EC 165 New Zealand Embassy Washington DC Vol #: 34
EC 166 Ms. Diane Weinstein Vol #: 34
EC 167 Mr. Dwight Ward Vol #: 34
EC 168 Mrs. Teresa Russo Vol #: 34
EC 169 Ms. Jennifer Otway Vol #: 34
EC 170 Mrs. Ursula Pelka Vol #: 34
EC 171 Miss. Erin Maupin Vol #: 34
EC 172 Mr. Marvin Huyser Vol #: 34
EC 173 Williamson Co. Cattlemen Vol #: 34
EC 174 Ms. Kelly Flood Vol #: 34
EC 175 Mrs. James Denison Vol #: 34
EC 176 Farm Sanctuary Vol #: 34
EC 177 Ms. Jo Tyler Vol #: 34
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/121405/121405.htm#02N0273
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/121305/121305.htm#02N0273
ROBERT LA 70455
DECEMBER I., 2005
Division of Dockets Management @IFA-306)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
RE: FDA Docket No. 2002N-0273
RIN 09 1 O-AF46
To Whom It May Concern:
Due to the fact the BSE issue is winding down and the USDA's Surveillance Program clearly
shows we do not have a BSE risk to the United States cattle population we appeal to you to
reconsider the proposed ruling above referenced. The current ~M~ina~t to ruminant feed ban
created in 1997 has been in force longer than most living animals and within two years will have
survived all living cattle. There is therefore, no need for additional feed restrictions based on
current compliance.
' We cannot understand why the FDA would impose unwarranted additional hardship and
expenses on the meat packing industry, not to mention the hazard created to human health that
might be caused by disposal, other than through the services of the rendering facilities. Such
expenses would also necessarily be extended to state agencies that would have to enforce and
oversee the handling of any such animal disposal.
We respectfully submit that there is no evidence that warrants such grave action set forth by the
above referenced proposal.
Yours truly,
Hyde Slaughter House, Inc.
Cc: Griffin Industries
Cc: AAMP
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000373-vol35.pdf
517 VALE WOOD ROAD, LORETTO, PENNSYLVANIA 15940
171 0 1 X300-86 l-6455
December 1,2805
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Docket No. 2002N-0273
RIN 0910-AF46
To Whom It May Concern:
I am writing to express my family dairy farm's opposition to the proposed FDA rule regarding the
use of cattle materials in all animal feed. More specifically, I oppose the prohibition of using "the
entire carcass of cattle not inspected and passed for human consumption if the brains and spinal
cords have not been removed." This provision would create unnecessary hardship on our family
farm and would eliminate our ability to economically dispose of dead animals. Because of the high
level of care that we give our animals, our farm mortalities are minimal. Even so, every family
farm must have a safe and affordable method of disposing of mortalities.
There does not appear to be any scientific reason to change the rule that has been in place since
1997. The current rule for testing and surveillance appears to be working, with 99% livestock
industry compliance.
The new rule would cause companies that accept dead animals to either discontinue their service
or to charge such high rates that it would no longer be economically affordable for family farmers
to use their disposal services. In introducing the Proposed Rule, Dr. Andrew von Eschenbach said
that "these additional measures.. .will make an already small risk even s er. .." Any =gind
benefit of tighter requirements is not economically justifiable due to the disproportionately large
costs to our nation's livestock producers.
In the not-so-distant past, we used to be able to dispose of farm mortalities 10calIy at no cost.
Under the existing regulations today? our onIy alterrative is to call o?re out-of-state company that
charges $40 per stop. If this company is forced to discontinue its recycling business, we literally
will have no alternative but to begin some type of on-farm burial or compost site for mortalities.
Surely the public health and environmental impact of thousands of small farms having to
independently handle their animal mortalities would be far worse than any marginal benefit of
tightening the existing regulation.
The new rule puts an undue burden on what is already an economically marginal business and is
unnecessary given the current level of scientific knowledge. On behalf of my family dairy farm, I
strongly urge the FDA not to adopt this new rule.
Sincerely,
Carissa Itle Westric
Vale Wood Farms
[email protected]
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000347-vol31.pdf
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/120705/120705.htm
0244 5 DEC-5 P2:07 -
November 9.2005
Division of Dockets
Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. IO61
Rockville, MD 20852
Dear Sir;
We understand that FDA has proposed to eliminate animal protein in animal
feeds. Previously, in 1997, FDA created a ruminant-to-ruminant feeding ban to reinforce
efforts to reduce the risk of BSE in the United States. This program has been successful
with over 99.5% compliance by the feed industry, rendering industry and those who use
feed in the United States.
It appears that additional regulation of animal protein feeding is unwarranted for
reducing the risk of BSE. Restrictions of animal movement into the United States from
other countries and testing of suspect animals has been sufficient to keep the threat of
BSE very low.
The Harvard University BSE assessment study, headed by Dr. Grey, clearly
showed that the BSE threat in the United States is very low, so low that it is practically
impossible to calculate.
These proposed restrictions are financially and environmentally disastrous to the
United States Agricultural Community. The restriction will result in cessation of dead
animal removal in Kentucky and other states creating a greater risk to the general public.
Livestock producers and dairymen will have nowhere to turn for disposal. There will be
increased human exposure to pathogens through handling of dead animals, polluted
streams and danger to pets and wildlife.
There is no need for further restrictions to protect citizens of the United States.
The current ruminant-to-ruminant ban is sufficient to reduce the risk of BSE. Also.
current USDA surveillance shows we do not have a BSE risk in the United States cattle
population.
We urge you to support the agricultural community and not allow these proposed
restrictions to become effective.
/ Gary Lane,(Ph.D., PAS, Dpl., ACAN
Director of Technical Service c 343
%JRKMANNM~LLS
1111 Perrywlle Road TEL 859-236-0400
Danville, KY 40422 FAX 859-236-7307
U'UJU~ hurkmann co,)r'
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000343-01-vol31.pdf
ALFALFA COUNTY FEEDERS, INC.
P.O. BOX 246
Ii1 * * 8
TOM KRAUS CHAD MATHEWS
MANAGER ASSISTANT MANAGER
November 30,2005
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Docket No. 2002N-0273
RIN 091 O-AF46
To Whom It May Concern:
I am writing to express my opposition to the proposed FDA rule regarding the use of cattle
materials in animal feed. This new rule would potentially create an unnecessary hardship on
farmers and cattle producers in the U.S. by removing the means to economically dispose of
dead animals.
There does not appear to be any scientific reason to change the rule that has been in place
and working since 1997. The current government's testing program has tested over 500,000
animals and only one has tested positive for BSE. The one positive test was in an animal
that was born before the current rule went into effect. No material from that animal got into
the feed chain. The current rule for testing and surveillance is working.
The new rule will force the companies that take dead animals for feed use to stop that
practice or to charge such high rates that it would put a serious economic strain on the
farmers and cattle producers. The alternative disposal means, such as burying the animals,
are also expensive and a potential environmental disaster. We will see much tighter
environmental regulations and fewer places to dispose of the material.
The new rule puts an undue burden on what is an already economically marginal business
and is unnecessary given the current level of scientific knowledge. I strongly urge the FDA
not to adopt the new rule.
Sincerely,
ALFALFA COUNTY FEEDERS, INC.
Tom Kraus
Manager
c 333
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000333-vol31.pdf
C 327 Maury County Government Vol #: 28
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000327-01-vol28.pdf
4705 Leland Drivs Gumming, GA 30041
770-886-2250 Phone 770-886-2296 Fax
November 21,2QW
To: Division of Dockets h/tan
Food and Drug Admiflis~~~tu~
5630 Fishers Lane
Room 1062
Rockvilte, tVtb 20852
From: in Custer
Vice Pr~sid~~~
American Piofeins, Inc.
Regarding:
hibited from Use in Animal Food or Feed
Dear Sir or Madame:
1, Brain and spinal cord from ca
2. Cattle not inspected
not 'i
w~s~rn~~~ff
nonam by late
3. Mechanicat t~s~~arat~d c
4. Taffuw
This document will ad
The current regulation, as a final r&3 in 1997,
stated objective:
Harvard Risk Asse
spontaneously in cd
on to two cases
The current feed @I and' un
this material, ancl like
negative consequences ~e~at~v~ to the env~~o~me~t~ anjma~, and
human health.
customers of ou
moda!& (@32,000,
in Georgia and Ala
this material would
moved from that
Sincereiy,
Kevin Custer
Vice President
Technical SetviCes
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000302-01-vol28.pdf
C 271 Center for Biosecurity, Food Safety, & Public Health (CBFSPH) Vol #: 27
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000271-01-vol27.pdf
C 275 Maryland Cattlemen's Association, Inc. Vol #: 27
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000275-01-vol27.pdf
November 282005
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Docket #2002N-0273
RIN 091 O&F46
To Whom It May Concern,
I am writing to express our opposition to the proposed FDA rule regarding the use of cattle materials in
animal feed. This new rule will create an unnecessary hardship on Maryland ers and cattle
producers by removing their means of economically disposing of deadstock.
Clearly, the existing science does not support this proposed change to a rule which has been in place,
and by all accounts, working well since 1997. The current testing protocol has examined over 500,000
animals with only one single positive BSE result. That single positive result was confirmed to be in
tissue from an animal born before the current feed rule went into affect. And, due to the existing layered
firewalls, no material from that 'animal ever entered the feed or food chain, e current rule for testing
and surveillance is working.
The specific impact of the proposed change to the existing rule will be either the total halting of all
deadstock retrieval by rendering companies or, the need to institute a signi~ca~tl~ higher fee structure
for any future retrieval. Higher costs of disposal will create a serious financial burden on cattle
producers and will discourage the use of future disposal services. Farmers will be forced to seek
alternative disposal means, for example burying, which could create unwanted environmental damage
and associated negative health impacts.' Wehave a system in place under the current rule that has proven
itself and is working well. It is a system that works without placing undue eeunomic burden on our cattle
producers.
In summary, we see no scientific data to support the proposed rule change. Conversely, we recognize
several years of data to substantiate to effectiveness af the current rule. The proposed change is not
needed and we strongly urge the FDA to NOT ADOPT the proposed rule changes,
S&Ott M. Barao, Ph.D.
Executive Director.
CC: Senators Sarbanes and Mikulski
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000275-01-vol27.pdf
C 281 West Virginia Custom Cuts, LLC Vol #: 27
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000281-01-vol27.pdf
C 138 Reddemeade Farm, Inc. Vol #: 21
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000138-01-vol21.pdf
C 118 Pet Food Institute (PFI) Vol #: 17
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000118-01-vol21.pdf
C 93 Embry Farm Service Vol #: 17
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000093-vol17.pdf
2002N-0273 Animal Proteins Prohibited in Ruminant Feed EC 36 Mr. Michael Hippert Vol #: 4 EC 37 Karem, Inc. Vol #: 4 EC 38 Dr. Robin Appel
http://www.fda.gov/ohrms/dockets/dailys/05/Nov05/111805/111805.htm#02N0273
2002N-0273 Animal Proteins Prohibited in Ruminant Feed C 56 South Dakota Department of Agriculture Vol #: 4
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000056-01-vol4.pdf
2004N-0264 Federal Measures to Mitigate BSE Risks: Considerations for Further Action C 209 Texas Association of Business Vol #: 23
http://www.fda.gov/ohrms/dockets/dockets/04n0264/04n-0264-c000209-01-vol23.pdf
2002N-0273 Animal Proteins Prohibited in Ruminant Feed EC 35 Mrs. Carla Yelkovan Vol #: 4
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02N-0273-EC35.htm
2002N-0273 Animal Proteins Prohibited in Ruminant Feed
EMC 14 B Sachau Vol #: 14
EMC 15 Number not used Vol #: 14
EMC 16 Union of Concerned Scientists Vol #: 14
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273_emc-000016.txt
2004N-0081 BSE Risk Materials in Foods and Cosmetics EMC 1147 I. Licea Vol #: 15
http://www.fda.gov/ohrms/dockets/dailys/05/Oct05/102705/102705.htm
2004N-0081 BSE Risk Materials in Foods and Cosmetics
EMC 1146 Pfizer Inc Vol #: 15
IN CONCLUSION, it is Pfizer's recommendation that the Interim Final Rule could be strengthened by INCLUDING the following:
1) For production of tallow derivatives, stress the importance of the rigorousness of the processing (transesterification or saponification) in minimizing the risk of transmitting TSE agents.
2) PROHIBIT the use of small intestine in materials for use in human food and cosmetics. ...
snip...
http://www.fda.gov/ohrms/dockets/dockets/04n0081/04N-0081_EMC1146-02.pdf
2004N-0081 BSE Risk Materials in Foods and Cosmetics C 150 The Dow Chemical Company (Dow) Vol #: 13
http://www.fda.gov/ohrms/dockets/dockets/04n0081/04n-0081-c000150-01-vol13.pdf
03-025IFA
03-025IFA-2
Terry S. Singeltary
From: Terry S. Singeltary Sr. [
[email protected]] Sent: Thursday, September 08, 2005 6:17 PM To:
[email protected]. 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
snip...
THE infamous USA SPORADIC CJDs, something to ponder; IF the USA TSE in cattle all does not look like UK BSE, why would all USA human TSE look like UK nvCJD??? over 20 strains of scrapie documented to date with new atypical strains now being documented in sheep and goat i.e. BSE. atypical strains of BSE/TSE showing up in cattle in different countries? ALL animals for human/animal consumption must be tested for TSE. ALL human TSEs must be made reportable Nationally and Internationally, OF ALL AGES... IN a time when FSIS/APHIS/USDA/FDA et al should be strengthening the TSE regulations, it seems corporate interest has won out again over sound science and consumer protection from an agent that is 100% fatal for the ones that go clinical. With the many different atypical TSEs showing up in different parts of the world, and with GWs BSE MRR policy (the legal policy of trading all strains of TSEs), the battle that has waged for the last 25 years to eradicate this agent from this planet will be set back decades, if not lost for good. ... 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
TSS
----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Wednesday, January 04, 2006 5:37 PM
Subject: Re: Group: U.S. not protected against mad cow
> ##################### Bovine Spongiform Encephalopathy #####################
>
> International Scientific Advisory Council
> McDonald's International Scientific Advisory Council adds further strength
> to our beef safety program by providing independent expert scientific and
> medical advice on bovine spongiform encephalopathy (BSE).
>
> COUNCIL MEMBERS
>
> Dr. Neil Cashman. Diener Professor of Neurodegenerative Diseases and
> Director, Neuromuscular Disease Clinic, Sunnybrook & Women's Health Sciences
> Center, University of Toronto. Specialist in motor neuron diseases and the
> cell biology of amyloid encephalopathies, including prion illnesses. Author
> of over 250 publications. Recipient of the 2000 Jonas Salk Prize for
> biomedical research.
>
> Dr. Dean Danilson. Vice President QAFS, Tyson Foods, Inc. Responsible for
> quality assurance and food safety programs for the retail division for fresh
> beef, pork, poultry and ready-to-eat meats.
>
> Dr. Linda Detwiler. Adjunct Professor, Virginia-Maryland Regional College of
> Veterinary Medicine, University of Maryland. Also provides private animal
> health consulting services, with specializations in transmissible spongiform
> encephalopathies, emergency preparedness, and animal product issues related
> to imports and exports. Formerly Senior Staff Veterinarian, Emergency
> Programs Staff, U.S. Department of Agriculture Animal and Plant Health
> Inspection Service, the unit principally responsible for surveillance,
> prevention, and education activities related to BSE. Member of various
> international working groups and advisory committees on TSEs. Author of
> numerous articles on the issues.
>
> Alan A. Harris, M.D. Professor of Internal Medicine and Preventive Medicine,
> Senior Assistant Chairman, Department of Internal Medicine, Hospital
> Epidemiologist, Rush-Presbyterian-St. Luke's Medical Center. Specialist in
> public health and foodborne illnesses. Fellow, Infectious Diseases Society
> of America. Fellow, American College of Physicians. Member, Society of
> Healthcare Epidemiology of America. Author or co-author of more than 140
> scientific publications.
>
> Dr. Beat Hörnlimann, MPH. Managing Director, SVISS Consulting, BSE 7192
> Ltd., an organization that provides expert advice on public and animal
> health, particularly with respect to BSE. Formerly Chief Veterinary Officer,
> Public Health Department, Kanton Zug, Switzerland. Led Swiss BSE and scrapie
> eradication program and served in numerous other senior-level staff and
> advisory positions related to TSEs. Author of a book on prions and prion
> diseases in humans and animals.
>
> Dr. David Kessler. Dean, School of Medicine, Yale University and former
> Commissioner, U.S. Food and Drug Administration. Author of A Question of
> Intent (on federal tobacco regulation efforts) and numerous articles in
> major medical journals. Member, Board of Directors, Elizabeth Glaser
> Pediatric AIDS Foundation, Doctors of the World, National Center for
> Addiction and Substance, Henry Kaiser Family Foundation. Recipient of
> numerous medical public service awards, including the American Heart
> Association National Public Affairs Special Recognition Award, American
> Academy of Pediatrics Excellence in Public Service Award, and American
> Cancer Society Medal of Honor.
>
> Dr. Colin Masters. Professor and Head, Department of Pathology, University
> of Melbourne. Specialist in neuropathology. Member, numerous national and
> international medical professional societies.
>
> Dr. Carols Messuti. Ministry of Livestock, Agriculture, and Fishing,
> Government of Uruguay and Delegate to the OIE, the UN's principal agency for
> animal diseases.
>
> Dr. Jeffrey W. Savell. Professor, E.M. ?Manny? Rosenthal Chairholder, and
> Leader, Meat Science Section, Department of Animal Science, Texas A&M
> University. Specialist in meat quality/consistency, food safety and
> nutrition. Past President, American Meat Science Association; member,
> Institute of Food Technologists, American Society of Animal Science, HACCP
> Alliance. Author or co-author of more than 250 articles and co-author of the
> Laboratory Manual for Meat Science. Recipient of numerous awards for
> research and teaching.
>
> Dr. James Toole. Walter C. Teagle Professor of Neurology, Professor of
> Public Health Sciences, and Director, Stroke Research Center, Wake Forest
> University School of Medicine. President, International Stroke Society;
> member and past-president, World Federation of Neurology; member and
> past-president American Neurological Association; fellow, Royal College of
> Physicians; master, American College of Physicians. Author of
> Cerebrovascular Disorders and over 600 medical textbook chapters; co-editor
> Handbook of Clinical Neurology. Former editor, Journal of the Neurological
> Sciences.
>
>
> http://www.mcdonalds.com/corp/values/socialrespons/resrecog/expert_advisors0
> /international_scientific.html
>
>
> 06/09/05
> BSE Roundtable Discussion Transcript
>
>
> http://www.aphis.usda.gov/lpa/issues/bse/BSE_roundtable_6_9_05.pdf
>
>
> NOW, let us look at another BSE ROUNDTABLE DISCUSSION by USDA et al in the
> year 2003, please note the BSE science on IHC testing then, and then compare
> to now, and then ponder those other 9,200 cattle of the infamous June 2004
> BSE cover-up program, that did not have rapid testing or WB, just IHC, the
> lease likely to find BSE/TSE ;
>
>
> USDA 2003
>
> We have to be careful that we don't get so set in the way we do things that
> we forget to look for different emerging variations of disease. We've gotten
> away from collecting the whole brain in our systems. We're using the brain
> stem and we're looking in only one area. In Norway, they were doing a
> project and looking at cases of Scrapie, and they found this where they did
> not find lesions or PRP in the area of the obex. They found it in the
> cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
> back and change the procedure for looking at Scrapie samples. In the USDA,
> we had routinely looked at all the sections of the brain, and then we got
> away from it. They've recently gone back.
> Dr. Keller: Tissues are routinely tested, based on which tissue provides an
> 'official' test result as recognized by APHIS
> .
>
> Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
> they still asking for the brain? But even on the slaughter, they're looking
> only at the brainstem. We may be missing certain things if we confine
> ourselves to one area.
>
>
> snip.............
>
>
> Dr. Detwiler: It seems a good idea, but I'm not aware of it.
> Another important thing to get across to the public is that the negatives
> do not guarantee absence of infectivity. The animal could be early in the
> disease and the incubation period. Even sample collection is so important.
> If you're not collecting the right area of the brain in sheep, or if
> collecting lymphoreticular tissue, and you don't get a good biopsy, you
> could miss the area with the PRP in it and come up with a negative test.
> There's a new, unusual form of Scrapie that's been detected in Norway. We
> have to be careful that we don't get so set in the way we do things that we
> forget to look for different emerging variations of disease. We've gotten
> away from collecting the whole brain in our systems. We're using the brain
> stem and we're looking in only one area. In Norway, they were doing a
> project and looking at cases of Scrapie, and they found this where they did
> not find lesions or PRP in the area of the obex. They found it in the
> cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
> back and change the procedure for looking at Scrapie samples. In the USDA,
> we had routinely looked at all the sections of the brain, and then we got
> away from it. They've recently gone back.
>
> Dr. Keller: Tissues are routinely tested, based on which tissue provides an
> 'official' test result as recognized by APHIS
> .
>
> Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
> they still asking for the brain? But even on the slaughter, they're looking
> only at the brainstem. We may be missing certain things if we confine
> ourselves to one area.
>
>
> snip...
>
>
> FULL TEXT;
>
>
> Completely Edited Version
> PRION ROUNDTABLE
>
>
> Accomplished this day, Wednesday, December 11, 2003, Denver, Colorado
>
>
> 2005
>
>
> National Veterinary Services Laboratory (NVSL) Immunohistochemistry (IHC)
> Testing Summary
>
> The BSE enhanced surveillance program involves the use of a rapid screening
> test, followed by confirmatory testing for any samples that come back
> "inconclusive." The weekly summary below captures all rapid tests conducted
> as part of the enhanced surveillance effort. It should be noted that since
> the enhanced surveillance program began, USDA has also conducted
> approximately 9,200 routine IHC tests on samples that did not first undergo
> rapid testing.
>
>
> http://www.aphis.usda.gov/lpa/issues/bse_testing/test_results.html
>
>
> http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
>
>
> TSS
>
>
> TSS
> ----- Original Message -----
> From: "Terry S. Singeltary Sr."
> To:
> Sent: Wednesday, January 04, 2006 5:14 PM
> Subject: Group: U.S. not protected against mad cow
>
>
> ##################### Bovine Spongiform Encephalopathy
> #####################
>
> Posted on Wed, Jan. 04, 2006
>
> Group: U.S. not protected against mad cow
> LIBBY QUAID
> Associated Press
> WASHINGTON - Researchers and the nation's No. 1 burger seller say the
> government is not fully protecting animals or people from mad cow disease.
>
> Stronger steps are needed to keep infection from entering the food chain for
> cattle, the critics wrote in comments to the Food and Drug Administration.
>
> The group includes McDonald's Corp., seven scientists and experts and a
> pharmaceutical supplier, Serologicals Corp.
>
> The government proposed new safeguards two months ago, but researchers said
> that effort "falls woefully short" and would continue to let cattle eat
> potentially infected feed, the primary way mad cow disease is spread.
>
> "We do not feel that we can overstate the dangers from the insidious threat
> from these diseases and the need to control and arrest them to prevent any
> possibility of spread," the researchers wrote.
>
> McDonald's said the risk of exposure to the disease should be reduced to
> zero, or as close as possible. "It is our opinion that the government can
> take further action to reduce this risk," wrote company Vice President Dick
> Crawford.
>
> In people, eating meat or cattle products contaminated with mad cow disease
> is linked to a rare but fatal nerve disorder, variant Creutzfeldt-Jakob
> Disease.
>
> No one is known to have contracted the disease in the United States. The
> disease has turned up in two people who lived in the U.S., but it's believed
> they were infected in the United Kingdom during an outbreak there in the
> 1980s and 1990s.
>
> The U.S. has found two cases of mad cow disease in cows. Since the first
> case, confirmed in December 2003 in a Canadian-born cow in Washington state,
> the government has tested more than half a million of the nation's 95
> million cows. The second case was confirmed last June in a Texas-born cow.
>
> "While this surveillance has not uncovered an epidemic, it does not clear
> the U.S. cattle herd from infection," the researchers said.
>
> The primary firewall against mad cow disease is a ban on using cattle
> remains in cattle feed, which the U.S. put in place in 1997. However, the
> feed ban has loopholes that create potential pathways for mad cow disease.
> For example, using restaurant plate waste is allowed in cattle feed.
>
> The Food and Drug Administration proposed in October to tighten the rules,
> but critics said glaring loopholes would remain.
>
> The FDA, which regulates animal feed, accepted public comments on the
> proposal through last month. An agency spokeswoman said Wednesday it would
> be inappropriate to respond to those comments.
>
> The critics said their biggest concern is that tissue from dead animals
> would be allowed in the feed chain if brains and spinal cords have been
> removed. Brains and spinal cords are tissues that can carry mad cow disease.
>
> In dead cattle that had the disease, infection had spread beyond brains and
> spinal cords. Leaving tissue from dead cattle in the feed chain would negate
> FDA's attempt to strengthen its safeguards, the critics said.
>
> The most effective safeguards, they said, would be to:
>
> _Ban from animal feed all tissues considered "specified risk materials" by
> the Agriculture Department, which requires that such materials be removed
> from meat that people eat. This includes tissues beyond the brain and spinal
> cord, such as eyes or part of the small intestine.
>
> _Ban the use of dead cattle in animal feed.
>
> _Close loopholes allowing plate waste, poultry litter and blood to be fed
> back to cattle.
>
> Within the meat industry, many say the FDA proposal is effective, although
> some companies contend new rules are unneeded. The American Meat Institute
> Foundation, which represents meat processing companies, backs the FDA
> proposal.
>
> "To take out the most potentially infected material, and that would be
> brains and spinal cords, that removes about 90 percent of the potential
> infectivity that is in an animal - if it's infected," said Jim Hodges, AMI
> Foundation president.
>
> Mad cow disease is the common name for bovine spongiform encephalopathy, or
> BSE, a degenerative nerve disease in cattle.
>
> ON THE NET
>
> Food and Drug Administration: http://www.fda.gov
>
> American Meat Institute: http://www.meatami.com/
>
>
> http://www.duluthsuperior.com/mld/duluthsuperior/living/health/13549744.htm
>
>
> TSS
>
>
>
>
>
> January 3, 2006 — FDA Veterinarian Newsletter -July/August 2005, Volume XX,
> No. IV
>
>
> snip...
>
>
> FDA Proposes Tighter Feed Ban to Prevent BSE
>
>
> The Food and Drug Administration on October 6 proposed banning certain
> high-risk cattle material from all animal feeds, including pet food, to
> strengthen safeguards against bovine spongiform encephalopathy (BSE).
>
> The proposed rule would add requirements to the 1997 feed rule, which bans
> most mammalian protein from use in feed for cattle and other ruminants. The
> rule proposes to eliminate 90 percent of all potentially infectious material
> from the feed supply.
>
> The proposed rule would ban from all feed:
>
> Brains and spinal cord of cattle 30 months old or older.
>
> Brains and spinal cord of cattle not inspected and passed for human
> consumption.
>
> The entire carcass of cattle not inspected and passed for human consumption
> if the brain and spinal cord has not been removed.
>
> Tallow, if it is derived from the material that would be prohibited under
> this rule and contains more than 0.15 percent insoluble impurities.
>
> Mechanically separated beef derived from material that would be prohibited
> under this rule.
>
> The proposed rule is designed to prevent any possible "leakage" of potential
> infectious material into cattle feed. The 1997 rule prohibits the use of
> most mammalian protein in feed for cattle and other ruminants, but allows
> the use of the protein, including the brain and spinal cord, in feeds for
> swine and poultry. The proposed rule would prevent the highest risk material
> from entering any part of the feed chain. Therefore, it is unlikely to find
> its way, by accident or deliberately, into feed for cattle.
>
>
> FDA believes that the 1997 feed rule has been extremely effective. However,
> with the discovery of BSE in the United States, FDA officials decided to
> further strengthen the measures already in place.
>
> Earlier position
>
> In January 2004, FDA announced it was planning to take other steps to
> address the BSE situation, including banning the use of poultry litter,
> plate waste, and blood and blood products in cattle feed. FDA also said it
> was planning to require dedicated facilities for handling feed and feed
> ingredients for ruminant animals.
>
>
> However, after further consideration, including recommendations from an
> International Review team convened by USDA to assess the controls in place
> to prevent the spread of BSE, FDA concluded that banning plate waste,
> poultry litter, and blood and requiring dedicated facilities are not needed
> if high risk tissues are excluded from animal feed channels. By keeping the
> high-risk material out of all feed, none could be spilled into poultry
> litter, so that route would be blocked. BSE rules by USDA's Food Safety
> Inspection Service (FSIS) and FDA's Center for Food Safety and Applied
> Nutrition (CFSAN) address food safety by keeping potentially infectious
> material out of food, thus eliminating plate waste as a possible vehicle.
> Blood has not been shown to be a vehicle for BSE infection, so it was not
> included in the proposed rule. (In addition, international standard setting
> agencies believe blood products are as safe for use in animal feed as milk
> and milk products.) And separate, dedicated facilities would not be needed
> because the proposed rule would eliminate the high-risk material, thus
> eliminating the concern for contamination of cattle feed.
>
>
> The proposal would cost the industry approximately $14 million to $24
> million per year, annualized over a 10-year period. This estimate includes
> the cost of complying and the cost of substitute feeds.
>
>
> The comment period for the rule closes December 20, 2005. Comments should be
> identified by Docket Number 2002N-0273, or RIM 0901-AF46. They can be
> submitted electronically through the Federal eRulemaking Portal:
> http://www.regulations.gov, or through the Agency website at
> http://www.fda.gov/dockets/ecomments.
>
>
> Written comments can be submitted via fax at 301-827-6870; or mailed, hand
> delivered, or sent by courier as a paper copy, on a disk or a CD-ROM, to
> Division of Dockets Management (HFA-305), Food and Drug Administration, 5630
> Fishers Lane, Rockville, MD 20852. The comments may be posted publicly on
> FDA's dockets, including any personal information submitted with the
> comment.
>
> U.S. Completes Investigation of BSE-Infected Cow in Texas
>
>
> After investigating the report of a cow in Texas found in June to be
> infected with bovine spongiform encephalopathy (BSE), Federal officials
> reported that appropriate safeguards were in place and working, which
> prevented the further spread of the disease.
>
>
> The infected animal was destroyed and did not get into the food, feed, or
> pet food supply, officials said. This was the first native born cow in the
> United States found to be infected with BSE.
>
>
> The U.S. Department of Agriculture (USDA), which is in charge of tracking
> and preventing animal disease, reported the infected animal to the Food and
> Drug Administration (FDA) on June 24, 2005. To determine if any other
> animals or offspring of animals from the herd of the infected animal were
> infected with BSE, USDA tracked down as many as it could of the 200 adult
> and 213 calves associated with the infected animals. No additional BSE was
> found.
>
>
> Meanwhile, FDA officials, along with the Texas Animal Health Commission and
> the Texas Feed and Fertilizer Control Service, investigated the sources of
> feed given the infected animal to see if they could discover the source of
> the infectious material. In addition, the Federal and State authorities
> tracked the disposition of all animals associated with the infected cow to
> be sure the provisions of FDA's 1997 BSE rule were followed.
>
>
> The investigation concluded that the 1997 feed rule, which prohibits the
> feeding of most mammalian protein to cattle and other ruminants, was being
> followed. At an August 30 press teleconference, Dr. Stephen Sundlof,
> director of FDA's Center for Veterinary Medicine, said that the
> investigation revealed that all companies involved were complying with the
> 1997 BSE feed rule.
>
>
> FDA's investigation identified 21 feed products used on the farm. FDA and
> State investigators went to three retail feed stores that had supplied the
> feed, and to nine feed mills that made the feed. According to Dr. Sundlof,
> "This investigation found no feed products used on the farm since 1997 had
> been formulated to contain prohibited mammalian protein."
>
>
> According to Dr. Sundlof, the infected cow, which was approximately 12 years
> old, had "very likely consumed contaminated feed well before 1997…."
>
>
> The animals associated with the infected cow were properly handled during
> slaughter and disposition under the feed rule, Dr. Sundlof said: "The
> investigation into the disposition of herd-mates from this farm involved
> visits to nine slaughter plants and eight rendering plants. The
> investigation found that all rendering plants were operating in compliance
> with the BSE ruminant feed rule. A review of the inspection history of each
> of these rendering firms found no violation."
>
>
> On October 6, FDA announced proposed rules to further reduce the risk of BSE
> in the United States. The proposal would ban certain high risk cattle
> material from use in all feeds and pet foods. (See related story on page 1,
> "FDA Proposes Tighter Feed Ban to Prevent BSE.")
>
>
>
> http://www.fda.gov/cvm/FdaVetJulAug2005.htm
>
>
>
>
> > The investigation concluded that the 1997 feed rule, which prohibits the
> feeding of
>
>
> > most mammalian protein to cattle and other ruminants, was being followed.
>
>
>
>
> FOR IMMEDIATE RELEASE
> P01-05
> January 30, 2001
> Print Media: 301-827-6242
> Consumer Inquiries: 888-INFO-FDA
>
>
> ----------------------------------------------------------------------------
> ----
>
> Note: On Dec. 23, 2003, the U.S. Department of Agriculture reported that a
> cow in Washington state had tested positive for bovine spongiform
> encephalopathy (BSE, or mad cow disease). As a result, information on this
> Web page stating that no BSE cases had been found in the United States is
> now incorrect. However, because other information on this page continues to
> have value, the page will remain available for viewing.
>
> 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.
>
> FDA believes that Purina Mills has behaved responsibly by first reporting
> the human error that resulted in the misformulation of the animal feed
> supplement and then by working closely with State and Federal authorities.
>
> This episode indicates that the multi-layered safeguard system put into
> place is essential for protecting the food supply and that continued
> vigilance needs to be taken, by all concerned, to ensure these rules are
> followed routinely.
>
> FDA will continue working with USDA as well as State and local officials to
> ensure that companies and individuals comply with all laws and regulations
> designed to protect the U.S. food supply.
>
>
>
> ----------------------------------------------------------------------------
> ----
>
>
> http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html
>
>
> NEWS RELEASE
>
> Texas Animal Health Commission
>
> Box l2966 •Austin, Texas 78711 •(800) 550-8242• FAX (512) 719-0719
>
> Linda Logan, DVM, PhD• Executive Director
>
> For info, contact Carla Everett, information officer, at 1-800-550-8242,
> ext. 710,
>
> or
[email protected]
>
> For Immediate Release--
>
> Feed Contamination Issue Resolved by FDA
>
> Although many of you may have heard the latest regarding the resolution of
> the cattle feed
>
> contamination situation in Texas, I wanted to ensure that you received this
> statement issued
>
> by the Food and Drug Administration (FDA), the agency in charge of
> regulating feed
>
> components. The FDA has said the cattle involved are to be rendered and the
> material will not
>
> enter ruminant or human food channels. The Texas Animal Health Commission
> (TAHC) will
>
> provided assistance to the FDA as requested and needed.
>
> FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT
>
> Today (Tuesday, Jan. 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 1,22
.....
