Monday, July 21, 2008

FDA’s BSE Final Rule Published; New Requirements Imposed on Renderers 2008, Volume VIII, No. I, FDA Veterinarian Newsletter

2008, Volume VIII, No. I, FDA Veterinarian Newsletter [PDF format]

FDA’s BSE Final Rule Published; New Requirements Imposed on Renderers

CVM Has Significant Role in Regulating Advertising, Labeling of New Animal Drugs

FDA Proposes Reauthorization of User Fees for Pioneer Drugs and Authorization of the First-Ever User Fees for Generic Drugs

Several Firms, Corporate Executives Indicted in Adulterated Pet Food Case

Understanding Genetic Variability in Dogs and Its Potential Role in Drug Development

Escherichia Coli O157:H7 Foodborne Illness and the Usefulness of the Critical Path in FDA’s Work to Combat It

Regulatory Activities – February 2008

Approvals for February 2008



FDA’s BSE Final Rule Published; New Requirements Imposed on Renderers

by Walt D. Osborne, M.S., J.D., Assistant Editor

After a rulemaking process that took 2-1/2 years, the Food and Drug Administration published on April 25, 2008 (73 F.R. 22720), a final rule that further strengthens existing safeguards against bovine spongiform encephalopathy (BSE) in the United States.

The new rule (21 CFR 589.2001) prohibits the use of the highest risk cattle materials in the food or feed of all animals. This measure augments FDA’s 1997 rule (21 CFR 568.2000), which prohibits the use of mammalian-origin proteins in feed fed to ruminants, but allows the use of these materials in feed for non-ruminant animals.

The Agency believes additional protections are needed even though compliance with the 1997 rule has been extremely high, and no new BSE cases have been reported in the United States since March 2006, when the second of two U.S. cases of BSE was detected. The new rule is expected to further reduce any cattle exposure to the BSE agent not elimi-nated by the 1997 feed rule. It is important to note that new cases of BSE continue to be found in cattle born in the United Kingdom after implementation of that country’s ruminant-to-ruminant feed ban. Also, FDA inspections of feed manufactur-ing firms have identified some instances of inadequate cleanout procedures, mislabeling, and recordkeeping deficiencies.

The new rule, which becomes effective April 27, 2009, is intended to mitigate such compliance failures and prevent the potential transmission of the BSE agent through cross-contamination or on-farm misfeeding.

As discussed in the preamble to the proposed rule, scientific data indicate that roughly 90 percent of BSE infectivity is contained in the brain and spinal cord of cattle, and only about 10 percent of BSE infectivity is present in such cattle parts as the distal ileum of the small intestine, the dorsal root and trigeminal ganglia, and the retina of the eye. For this reason, the new rule focuses on the removal of cattle brain and spinal cord from animal feed.

FDA received more than 800 comments to the October 5, 2005, proposed rule, including comments from industry, State and local governments, trade associations, academia, and consumers. Reviewing all of the comments and respond-ing to them in the preamble to the final rule proved to be a time-consuming task. In particular, comments challenging FDA’s estimate of the cost of the new regulation necessitated a re-analysis of the economic impact of the rule. In re-sponse to the comments, some changes to the proposed rule are reflected in the final version.

What is prohibited?

FDA’s new rule prohibits the use of the following cattle materials in the food or feed of all animals:

The entire carcass of 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.

All of these materials constitute “cattle materials prohibited in animal feed,” or CMPAF.

One change the Agency made in going from the proposed rule to the final rule concerns the requirement to remove the brain and spinal cord from dead stock cattle, that is, cattle that die of injury or disease before they are ever sent to slaugh-ter. As defined in the proposed rule, CMPAF includes the brains and spinal cords from cattle of any age not inspected and passed for human consumption (dead stock cattle), or the entire carcass, if brain and spinal cord were not removed. The rationale for the decision to require brain and spinal cord removal from dead stock cattle of all ages was that European surveillance data shows that cattle not inspected and passed for human consumption were included in the group of cattle at highest risk of BSE. In addition, FDA noted that government inspection personnel were not routinely present in render-ing plants to verify the age of dead cattle. FDA specifically requested and received comments on this issue.

As a result, the new rule does not require brain and spinal cord removal from dead stock cattle if the cattle are shown to be less than 30 months of age. FDA made this revision based on comments indicating that it is feasible to put processes in place to age such cattle and that very little risk reduction is gained by excluding material from such cattle. The final rule requires renderers to develop and maintain written procedures for determining the age of and/or removing the brain and spinal cord from dead cattle, and to make the written procedures available for FDA inspection. The recordkeeping requirements for renderers are discussed in greater detail below.

Country exclusion

In response to comments to the proposed rule, FDA revised the final rule so that the Agency may designate a country as not subject to the new requirements. Any country seeking such a designation must submit a written request to the Di-rector of CVM, providing information about that country’s BSE case history, risk factors, measures to prevent the introduc-tion and transmission of BSE, and any other information relevant to determining the country’s BSE status. Detailed re-quirements for requesting this designation are set forth in the preamble to the final rule. The Agency may revoke a coun-try’s exclusion status if a review of relevant information shows that the country no longer qualifies for the exclusion.

Renderers’ responsibilities

During inspections at rendering facilities, FDA intends to verify that renderers maintain records sufficient to demonstrate that material rendered for use in animal feed does not contain CMPAF.

At those rendering establishments that render dead stock cattle for animal feed use, investigators will review written procedures for aging animals and for effectively excluding the brain and spinal cord from animals 30 months of age and older. Investigators will also be verifying that actual practices are effective. The final rule was revised to address com-ments regarding recordkeeping and the need for verifying that CMPAF has been segregated from raw materials collected from slaughter establishments. The final rule clarifies that a renderer’s records must include certification from each sup-plier, or other documentation acceptable to FDA, that CMPAF has been excluded from materials to be rendered for use in animal feed. Certification or other documentation from the supplier will be considered acceptable, provided it includes a description of the supplier’s segregation procedures, a statement by the supplier that its segregation procedures were in place prior to supplying any cattle material to the renderer, and records of the renderer’s periodic review of the suppliers’ certification or other documentation. Other methods acceptable to FDA, such as third-party certification, may also be used by renderers to document that suppliers have excluded CMPAF from material supplied to the renderer.

Disposing of CMPAF

As a result of this final rule, a large volume of byproducts from the beef and cattle industries will no longer be allowed to be rendered for animal feed use. Other means of disposing of this material include landfill, composting, incineration, alka-line hydrolysis, and burial. The effective date of April 27, 2009, was established to allow 12 months for new disposal pat-terns to be developed.


As always, FDA’s mission continues to be the protection of public and animal health. This new rule is yet another step FDA is taking to eliminate opportunities for cattle exposure to the BSE agent in feed. It provides a margin of safety by re-ducing the consequences of inadvertent cross-contamination or on-farm misfeeding, thereby helping to ensure that the U.S. beef supply remains safe.

More information about BSE and the BSE final rule is available on the CVM Web site at

> The new rule, which becomes effective April 27, 2009

Wednesday, July 16, 2008

Implementation of 2008 Feed Ban Enhancements Questions and Answers July 15, 2008

Over the next 8-10 weeks, approximately 40% of all the adult mink on the farm died from TME. Since previous incidences of TME were associated with common or shared feeding practices, we obtained a careful history of feed ingredients used over the past 12-18 months. The rancher was a "dead stock" feeder using mostly (>95%) downer or dead dairy cattle and a few horses. Sheep had never been fed.


Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)

[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


2 January 2000

British Medical Journal

U.S. Scientist should be concerned with a CJD epidemic in the U.S., as well

15 November 1999

British Medical Journal

vCJD in the USA * BSE in U.S.

Docket APHIS-2006-0041 Docket Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived from Bovines Commodities Docket Type Rulemaking Document APHIS-2006-0041-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived From Bovines Public Submission APHIS-2006-0041-0006 Public Submission Title Comment from Terry S Singletary Sr Views Add Comments How To Comment


MY personal belief, since you ask, is that not only the Canadian border, but the USA border, and the Mexican border should be sealed up tighter than a drum for exporting there TSE tainted products, until a validated, 100% sensitive test is available, and all animals for human and animal consumption are tested. all we are doing is the exact same thing the UK did with there mad cow poisoning when they exported it all over the globe, all the while knowing what they were doing. this BSE MRR policy is nothing more than a legal tool to do just exactly what the UK did, thanks to the OIE and GW, it's legal now. and they executed Saddam for poisoning ???

go figure....

Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518

ONE FINAL COMMENT PLEASE, (i know this is long Dr. Freas but please bear with me)

THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted blood from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone.

These are the facts as i have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species. ...

Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518

snip... 48 pages...

SEAC Draft minutes of the 100th meeting held on 25th April 2008


No comments: