• If you are having problems logging in please use the Contact Us in the lower right hand corner of the forum page for assistance.

Substances Prohibited From Use in Animal Food or Feed DOCKET

flounder

Well-known member
Friday, April 25, 2008

Substances Prohibited From Use in Animal Food or Feed [Docket No.
2002N-0273] (Formerly Docket No. 02N-0273) RIN 0910-AF46


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: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending 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
entire carcass of bovine spongiform encephalopathy (BSE)-positive cattle;
the brains and spinal cords from cattle 30 months of age and older; the
entire carcass of cattle not inspected and passed for human consumption that
are 30 months of age or older from which brains and spinal cords were not
removed; tallow that is derived from BSE-positive cattle; tallow that is
derived from other materials prohibited by this rule that contains more than
0.15 percent insoluble impurities; and mechanically separated beef that is
derived from the materials prohibited by this rule. These measures will
further strengthen existing safeguards against BSE.

DATES: This final rule is effective April 27, 2009. The Director of the
Office of the Federal Register approves the incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of a certain publication
in new 21 CFR 589.2001 effective April 27, 2009.

FOR FURTHER INFORMATION CONTACT: Burt Pritchett, Center for Veterinary
Medicine (HFV-222), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-453-6860, e-mail: [email protected]

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction II. Comments on the Proposed Rule A. General Comments B.
Comments on Proposed New Sec. 589.2001--Cattle Materials Prohibited in
Animal Food or Feed C. Comments on Proposed Amendments to Sec.
589.2000--Animal Proteins Prohibited in Ruminant Feed III. Description of
the Final Rule A. Definitions B. Requirements C. Recordkeeping and Access
Requirements D. Changes to Sec. 589.2000--Animal Proteins Prohibited in
Ruminant Feed IV. Analysis of Economic Impacts A. Summary of Final
Regulatory Impact Analysis B. Cost Effectiveness of Final Rule and
Alternatives C. Need for Regulation D. Benefits E. Costs F. Government Costs
G. Sensitivity Analysis H. Regulatory Flexibility Analysis V. The Small
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) VI. Paperwork
Reduction Act of 1995 VII. Environmental Impact VIII. Federalism IX.
References

I. Introduction

snip...see different commentors and replies back ;

(Comment 6) A few comments asked FDA to recognize that the USDA 18- month
surveillance snapshot may not be an accurate indication of BSE prevalence in
the United States. Specifically, because the BSE cases to date are likely
clustered in time and location, USDA's surveillance results may
underestimate the true risk.

(Response) FDA stated in the preamble to the proposed rule that the
detection of one BSE case in over 418,000 samples analyzed under USDA's
enhanced surveillance program at the time of the publication of the proposed
rule indicates that the prevalence of BSE is very low in the U.S. cattle
population. FDA notes that USDA has conducted surveillance for BSE since
1990. A July 20, 2006, USDA report entitled ``An Estimate of the Prevalence
of BSE in the United States'' supports FDA's qualitative statement of a very
low prevalence of BSE in the United States (Ref. 3). According to the
report, a model developed in Europe was used to calculate U.S. BSE
prevalence from two BSE cases detected in 735,213 samples collected over a
7-year period ending in March 2006. Results of this analysis support a
conclusion that the prevalence of BSE in the U.S. cattle population is less
than one infected animal per million adult cattle. FDA remains confident in
the two models used by USDA. The most likely values calculated by these
models for the estimated number of cases were 4 or 7 infected animals out of
42 million adult cattle. USDA's analysis was submitted to the scrutiny of a
peer review process, and the expert panel agreed with the appropriateness of
USDA's assumptions and the factors it considered, as well as with the
estimate of BSE prevalence.

(Comment 7) One comment noted that the effectiveness of the feed ban,
especially at the farm level, is not known.

(Response) Inspection results indicate that compliance by U.S. animal feed
industry is high. However, FDA agrees that it is very difficult to assess
compliance with the ruminant feed rule at the farm level. FDA believes
excluding certain cattle-derived risk materials from all animal feed
channels will minimize any residual risks from on- farm misfeeding.

(Comment 8) Two comments indicated that the agency's feed control measures
for ensuring compliance with the 1997 ruminant feed rule have been
inadequate, citing a Government Accountability Office (GAO) study as
evidence.

(Response) FDA disagrees with these comments. FDA believes its enforcement
activities are adequate for ensuring industry compliance with the 1997
ruminant feed rule. The agency's response to the GAO's study can be found in
Appendix VI of the GAO's report (Ref. 4).

(Comment 9) One comment speculated that, in some species, atypical BSE might
be more pathogenic than typical BSE.

(Response) FDA is not aware of any scientific evidence that atypical BSE is

[[Page 22724]]

more pathogenic than typical BSE. Therefore, the agency believes that the
controls in this final rule are appropriate.

full text ;

http://edocket.access.gpo.gov/2008/08-1180.htm


========================PLEASE NOTE TSS 2008=====================

***2008 Atypical forms of BSE have emerged which, although rare, appear to
be more virulent than the classical BSE that causes vCJD.

Pierluigi Gambetti, MD Director, National Prion Disease Pathology
Surveillance Center

Stephen M. Sergay, MB, BCh President, American Academy of Neurology

Progress Report from the National Prion Disease Pathology Surveillance
Center An Update from Stephen M. Sergay, MB, BCh & Pierluigi Gambetti, MD

April 3, 2008

http://www.aan.com/news/?event=read&article_id=4397&page=72.45.45



=======================PLEASE NOTE TSS 2008======================


April 25, 2008

Strengthening Beef Safety

The Food and Drug Administration (FDA) has issued a final regulation barring
certain cattle materials from all animal feed, including pet food. FDA
regulates animal feed and drugs. The U.S. Department of Agriculture (USDA)
regulates meat. Together the agencies enforce regulations that ensure that
specific risk materials are kept out of the human food supply.

http://www.fda.gov/consumer/updates/beefsafety042508.html



Greetings again,

IS this strengthening beef safety, or dangling another carrot out in front
of the consumer $$$


*** DO NOT forget what was originally promised years ago !!!


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.


snip...please see full text ;


http://madcowfeed.blogspot.com/2008/04/substances-prohibited-from-use-in.html


TSS
 

QUESTION

Well-known member
:roll: :roll: :roll: Imagine that the FDA banning BSE positive animals from the human or animal food chain by 2009. Wasn't that already done or is it still acceptable to feed BSE positive animals to other animals and humans? Get caught up with the rest of the world if you allow meat from contaminated animals in the food chain it will spread , not exactly astrophysics. And a european groups has a model that say the are probably one positive per million adult animals or close to it and 42 million in the US that is how many positives running around loose in the US,while the FDA estimates 4 to 7 animals can anyone explain the difference in numbers? Maybe some day the US will catch up to the rest of the world on eliminating BSE :p
 

Sandhusker

Well-known member
QUESTION said:
:roll: :roll: :roll: Imagine that the FDA banning BSE positive animals from the human or animal food chain by 2009. Wasn't that already done or is it still acceptable to feed BSE positive animals to other animals and humans? Get caught up with the rest of the world if you allow meat from contaminated animals in the food chain it will spread , not exactly astrophysics. And a european groups has a model that say the are probably one positive per million adult animals or close to it and 42 million in the US that is how many positives running around loose in the US,while the FDA estimates 4 to 7 animals can anyone explain the difference in numbers? Maybe some day the US will catch up to the rest of the world on eliminating BSE :p

There is no way that Canada is "Catching them all" as they claim without testing them all. That means that BSE positive animals are entering the food chain. Where is your outrage about that?
 

QUESTION

Well-known member
SandH get on topic or go somewhere else :roll: What problem do you have, until april 27, 2009 bse is not transmissible thru contaminated feed so why would you worry it? :p :oops: How many bse positives have been found in the US since the border opened last fall to OTM cattle ? get real, stay on topic and keep up.
 

Sandhusker

Well-known member
QUESTION said:
SandH get on topic or go somewhere else :roll: What problem do you have, until april 27, 2009 bse is not transmissible thru contaminated feed so why would you worry it? :p :oops: How many bse positives have been found in the US since the border opened last fall to OTM cattle ? get real, stay on topic and keep up.

Your comment, "Imagine that the FDA banning BSE positive animals from the human or animal food chain by 2009"

You also said, "Get caught up with the rest of the world if you allow meat from contaminated animals in the food chain it will spread , not exactly astrophysics."

Canada is allowing meat from contaminated animals to enter the food chain. How do you get off shaking your finger and lecturing others?
 

Silver

Well-known member
Sandhusker said:
QUESTION said:
SandH get on topic or go somewhere else :roll: What problem do you have, until april 27, 2009 bse is not transmissible thru contaminated feed so why would you worry it? :p :oops: How many bse positives have been found in the US since the border opened last fall to OTM cattle ? get real, stay on topic and keep up.

Your comment, "Imagine that the FDA banning BSE positive animals from the human or animal food chain by 2009"

You also said, "Get caught up with the rest of the world if you allow meat from contaminated animals in the food chain it will spread , not exactly astrophysics."

Canada is allowing meat from contaminated animals to enter the food chain. How do you get off shaking your finger and lecturing others?

Looks to me like he took a page right out of your book SH! :lol: :lol: :lol:
 

QUESTION

Well-known member
Same old argument Sandh. And i'll respond the same - show me an example where an animal confirmed to have BSE/BASE was allowed in the human food chain in Canada. Re-read the rule it isn't illeagal or against food production regulations for a company to use an animal that knowingly has BSE/BASE to be put into the human foodchain in the US. That is the outrageouse part. This is NOT allowed in any country who is serious about BSE/BASE. It is way past stupidity to wait until 2009 to implement rules the rest of the world has acccepted years ago. So sandH the differece is if a animal with BSE accidently got into the foodchain and got missed who could be held accountable, it is a mistake. But as read the rule until april 2009 any company can take the remanents from a cow with BSE and put it in the foodchain for human consumption and not break any rule and not be accountable for knowingly endangering the health of the consumer. And you want to argue that this is OK. :oops: Please i want to see your justification and defense that this should be allowed. I just want some insight into how anyone could possibly think that this is not immoral and wreckless at a minimum. Explain away SandH.
 

Sandhusker

Well-known member
I knew you would respond the same because you refuse to accept reality, it puts you in a rediculous hypocritical position.

It's not a mistake if a BSE positive animal gets into the food chain when you know you've got healthy appearing positives that you're simply not testing. That is willful negligence.
 

QUESTION

Well-known member
SandH a rediculose position?Oh YES, You are so right it is rediculose to think eating products from and animal confirmed to have BSE/BASE could have any negative effects on human health :roll: You can cry all you want. I just want to see how you jusity allowing processors to use known BSE positives for the production of food for human acceptable for another year. This isn't genius thinking, it has been proven humans can aquire vCJD by eating beef contaminated BSE. Care to explain how this doesn't apply in the US until april 2009.
As for banning any part of an animal having BSE from the human foodchain that law went into effect when the first indegionouse case was found back in 03 in canada. SandH Why the resistance to such an obvious regulation? I known you like loopholes and this one is closing But should have been closed years ago.
Keep on beating that dead horse but until you find healthy appearing BSE positive animals that canada is missed on US soil all you have is conjecture. It should easy to prove as i have told you on many occaisions buy up a bunch of canadian cows, they will be the ones with in the country of canada. And get them slaughtered submit samples to labs outside the US , and keep a established chain of custody. And submit all the positives and the proof they are from canada to your government and the OIE and your problem with canada will be solved. I suggested this over a year ago why no action.? Oh yeah it will still be legal for about a year to put known BSE positives into the human foodchain in the US. :roll:
But by all means keep on making up hypothedical situations and not explaining why you support immoral and unethical positions in the real world?
 

Sandhusker

Well-known member
I don't recall supporting nor attempting to justify anything our packers or USDA have done with BSE. Would you like to bring my quotes or is it easier to make your points by putting words in my mouth?

If you think positives are entering the food chain down here, why don't YOU buy up US cows, have them tested and then prove we have BSE? Your suggestion that I do so with Canadian cows is both rediculous and hypocritical.

The facts are that every single one of your positive cases would of went by untested and unknown and got into the human food chain had they been slaughtered prior to showing the clinical signs that warranted testing. Considering the incubation period of the disease, that is a window of 5 or more years. It is a mathematical certainty that healthy appearing BSE positive (as these animals were for most of their lives) animals are getting into the food chain because they are not tested. But you're "Getting them all". And you're lecturing me on immoral and unethical positions.....
 

PORKER

Well-known member
Considering the incubation period of the disease, that is a window of 5 or more years.

At least when Rons BSE urine test gets here ,the end will be in sight.
 

QUESTION

Well-known member
Sandh You still want to play somantics. I've asked time and time again why not ban the use of BSE contaminated meat from the human foodchain now not in another year as it is common knowledge that eating contaminated beef greatly increases the risk of aquiring vCJD. I am sure you are going to go off on some rant about how there are so many positive cows that are being missed because we in canada are not testing everything. Or some other obtuse issuse regaurding what you have been told to believe by r-calf or maybe a personal attack on myself as you will not or cannot answer my questions. By the way i am a proponent manditory testing of every animal born after 2003 bound for human consumption in North america let alone Canada.
As for your earlier question where do i get off lecturing and shaking my finger. The BSE infected beef dumped into the human food chain is not only against regulations but a ciminal offense to allow it into the human food chain so why should the US be allowed to not follow basic rules for public health and export that type of product to canada when it is illegal to do so in Canada. where do you get off, As the US exports to Canada? CanadaExplain that to me?
 

Sandhusker

Well-known member
Q, why are you trying to argue with me on what the USDA is doing? I've asked you to bring a quote of mine showing support for them, but you'd rather pretend I said something that I didn't.

You can brag about BSE infected animals being banned from the food chain in Canada all you want, but the facts are that it is a certainty that they are still getting in, as I've pointed out repeatedly. Do realize that an animal can have BSE 5 or more years before they physically show it? Think about that. You need to quit ignoring the basic facts of the disease.
 

QUESTION

Well-known member
Sandh, you claim there are positives going into the human foodchain in canada all you want but could you show me the documented eveidence you have. And because i say so isn't good enough :roll:
Get your agencies straight the FDA will be banning products from BSE positives entering the foodchain in about a year. Why don't you think it should happen sooner? Has r-calf not told you what to say or think yet. Maybe email the office so you can get appoval to post their opinion.
Maybe one time you will answer a single question i ask when i respond to yours.
But by all means post more unsubstanciated propaganda maybe even make some sort of childish personal attack.
 

Sandhusker

Well-known member
QUESTION said:
Sandh, you claim there are positives going into the human foodchain in canada all you want but could you show me the documented eveidence you have. And because i say so isn't good enough :roll:
Get your agencies straight the FDA will be banning products from BSE positives entering the foodchain in about a year. Why don't you think it should happen sooner? Has r-calf not told you what to say or think yet. Maybe email the office so you can get appoval to post their opinion.
Maybe one time you will answer a single question i ask when i respond to yours.
But by all means post more unsubstanciated propaganda maybe even make some sort of childish personal attack.

You want me to prove the existence of cases in Canada that would require testing results of tests that aren't being done. My third-grader could see that "trap" that you're trying to set. Why don't you prove to me that there are any BSE cases in the US now? If you want to use grade-school arguements, try some of your own medicine.

I've already explained to you more than once how BSE positives are getting in the food chain. For you to understand my explaination, you would have to have a rudimentary grasp on the basics of BSE, which you lack. Here's something that will help bring you up to speed;

Homework exercise # 1) Look up the incubation period. From what you will learn, apply that knowledge to exercise #2

Homework exercise # 2) Explain to me how Canada is catching the healthy appering BSE positives if they're not testing them - OR - explain how they ARE being tested - OR - explain how there are no healthy appearing BSE positive animals in Canada.
 

QUESTION

Well-known member
Again :roll: answering questions with more different questions. This is fultile!!! all you want to do is place blame. While what i want is to figure out a way to eliminate BSE and the transmission to humans. :roll: Keep on playing more games watch more people get sick and die from vCJD. And explain to the families who are losing people ,who they should be blaming. Amazingly enough with all the (BSE contaminated :roll: ) canadian beef being eaten there has yet to be a case of vCJD in canada that has been linked to the consumption of canadian beef in canada. While suspect cases of vCJD are already starting to show up in the US. I am sure you are going to try and blame this on canadian beef as well, but canadians are not getting sick i wonder why sandh ? That is where this whole thread starts - why wait another year to make it illeagal to put BSE/BASE contaminated beef in the human foodchain? I am sure you can tell me the r-calf standard excuse for endagering human health sandh?
 

PORKER

Well-known member
what i want is to figure out a way to eliminate BSE and the transmission to humans. Q Quote

Help Fund Ron's Live BSE urine test Q.
 

Sandhusker

Well-known member
QUESTION said:
Again :roll: answering questions with more different questions. This is fultile!!! all you want to do is place blame.

I noticed you didn't do your homework. Are you afraid of the truth?

I'm not blaming, I'm stating facts that you just dance around or stick your head in the sand on.

While what i want is to figure out a way to eliminate BSE and the transmission to humans. :roll:

Horsecrap. That is why you refuse to acknowledge healthy appearing untested positives entering the food chain? You're not ready for Sainthood yet.

Keep on playing more games watch more people get sick and die from vCJD. And explain to the families who are losing people ,who they should be blaming.

You can tell them what you've told me, "Prove it".


Amazingly enough with all the (BSE contaminated :roll: ) canadian beef being eaten there has yet to be a case of vCJD in canada that has been linked to the consumption of canadian beef in canada. While suspect cases of vCJD are already starting to show up in the US. I am sure you are going to try and blame this on canadian beef as well, but canadians are not getting sick i wonder why sandh ?

I take it you've got all the mileage out of the arguement, "The US and Canada have traded so long, you have to have what we have"?

That is where this whole thread starts - why wait another year to make it illeagal to put BSE/BASE contaminated beef in the human foodchain? I am sure you can tell me the r-calf standard excuse for endagering human health sandh?

There is no excuse to wait, just as there is no excuse to ignore the facts that I'm trying to get through your head. If you choose to ignore the untested healthy appearing animals getting into the food chain while Canada claims "We're getting them all", then you've got no dang call to point your finger at anybody else. You're a flipping hypocrite.

What is your excuse for looking the other way while human health is endangered?
 

flounder

Well-known member
PORKER said:
what i want is to figure out a way to eliminate BSE and the transmission to humans. Q Quote

Help Fund Ron's Live BSE urine test Q.


hmmm, i pondering out loud here porker and ron.

could the U.S. gov have bought up your test to NOT use it, and make dang sure no one else does too $$$

they have played with this urine test for more than a decade (when narang was first working on it etc).

how much more time do they need to validate$$$

if USDA et al are not going to let creekstone et al test to find, it then makes no difference whehter or not ron's test is 100% validated or not, they are simply not going to use any test that would find BSE typical or atypical. thats why they shut the testing down to almost nothing, right after they found the two atypical BSE cases in Texas and Alabama...


An Edmonton company is confident it has a cheap, ground-breaking test for mad cow disease, but the test's British inventor who claims to have first made the link between BSE and the disease's human form insists he still holds the rights. Despite their differences, inventor Harash Narang and BSE Prion Solutions Inc. agree the test holds amazing potential to quickly and inexpensively test live cattle for bovine spongiform encephalopathy better known as mad-cow disease. He is no longer part of the research, but work on it continues at the United States National Prion Disease Pathology Surveillance Center at Case Western Reserve University in Cleveland.


http://blog.case.edu/casedaily/2006/07/21/case_daily


CJD QUESTIONNAIRE

http://cjdquestionnaire.blogspot.com/


BSE BASE MAD COW TESTING TEXAS, USA, AND CANADA

http://madcowtesting.blogspot.com/


TSS
 
Top