SEARCH VEGSOURCE:

 

 

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




From: TSS ()
Subject: Substances Prohibited from Use in Animal Food or Feed, Proposed Rule, Docket No. 2002N-0273 C-534 VOL 45 (PhRMA) and Entered On February 17, 2006
Date: March 10, 2006 at 5:50 pm PST


Subject: Substances Prohibited from Use in Animal Food or Feed, Proposed Rule, Docket No. 2002N-0273 C-534 VOL 45 (PhRMA) and Entered On February 17, 2006
Date: March 10, 2006 at 5:23 pm PST

Marie A. Vodicka, PhD

Assistant Vice President

Biologics & Blotechnology

Scientlflc & Regulatory Affairs

SCIENCE & REG AFFAIRS

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, rrn . 1061

Rackville, MD 20862


Re: Substances Prohibited from Use in Animal Food or Feed, Proposed Rule, Docket

No. 2002N-0273

February 14, 2006

Dear Sir or Madam :

The Pharmaceutical Research and Manufacturers of America (PhRMA) is providing

comment to the proposed rules issued. by the Food and Drug Administration (FDA)

Center for Veterinary Medicine (CVM) entitled Substances Prohibited From Use in

Animal Food or Feed ; Proposed Rule, 21 CFR Part 589; 70 Federal Register 58570

(October 6, 2005). PhRMA applauds the FDA's continued actions to protect the cattle

population of the United States from BSE (bovine spongiform encephalopat.hy) and, as

discussed further below, strongly supports additional safeguards in addition to those

proposed in amended 21 CFR Part 589_

PhRMA represents the country's leading research-based pharmaceutical and

biotechnology companies, which are devoted to inventing medicines that allow patients

to lead longer, healthier and more productive lives. Investing more than $30 billion

annually in discovering and developing new medicines, PhRMA companies are leading

the way in the search for cures .

Animal-derived materials are ubiquitous in our lives and have many important uses .

They are often used in pharmaceutical manufacturing and are sourced according to

Pharmaceutical Research and Manufacturers of America

Page 2of7

guidelines issued by regulatory authorities and the specifications outlined by the quality

systems of the pharmaceutical company. The BSE status of the country where the

animal lived and an assessment of the controls in place to prevent the spread of the

disease, if it should occur, are important considerations in sourcing bovine-derived

materials . While a country may have animals diagnosed with BSE, evaluation of the

measures put in place to halt the spread of the disease is as crucial as identification of

the disease itself. PhRMA continues to support an internationally harmonized, sciencebased

approach to determining appropriate safeguards against BSE. PhRMA believes

that FDA efforts to communicate these science-based concepts to our trading partners

worldwide are critical. It is just as important to institute sound science-based policies in

order to stop the spread of disease.

Consideration of the safeguards enacted in the various countries where ruminant derived

raw materials are sourced provides the underpinning for regulatory guidance.

The cattle population of the United States must continue to be an acceptable source of

bovine-derived raw materials for human food and pharmaceutical manufacturing. As

such, continual re-evaluation of existing safeguards against BSE must occur based on

new information and advances in science . Due to confirmation that BSE is indeed

present in North America, rapid implementation of enhanced safeguards for cattle and

animal feed is required .

We continue to be concerned about the amount of time it has taken the Center for

veterinary Medicine (CVM) to institute any changes to the 1997 feed ban; a lot has

happened since 1997, not the least of which is the identification of a BSE cow native to

the United States (June 2004). As we have urged for many years, the 1997 feed ban

must be enhanced based on new information, including the experimental results that

Page 3 of 7

show as little as 0.001 gram of infected tissue fed orally to cattle may result in BSE

infection of cattle1.

PhRMA supports actions of the Food and Drug Administration Center for Veterinary

Medicine (FDA CVM ) to extend certain provisions in the 1997 Ruminant to Ruminant

feed ban to all animal feed . As noted in the 1997 ruminant feed final rule (§ 589.2000)

and described in the October 6, 2005 Federal Register notice,2 the use of mammalian

derived proteins is currently prohibited in ruminant feed, with the exception of certain

proteins believed not to pose a risk of BSE transmission . These exceptions to the

definition of "protein derived from mammalian tissues" include: blood and blood

products; gelatin; inspected meat products which have been cooked and offered for

human food and further heat processed for feed (such as plate waste and used

cellulosic food casings), referred to herein as "plate waste" ; milk products (milk and

milk protein) ; and any product whose only mammalian protein consists entirely of

porcine or equine protein. The 1997 ruminant feed final rule does not prohibit ruminant

animals from being fed processed animal proteins derived from non-mammalian

species (e .g ., avian or aquatic animals). The 1997 ruminant feed final rule permits the

manufacture of non-ruminant feed containing prohibited mammalian protein and

ruminant feed on the same premises, provided that separate equipment is used in the

production of ruminant feed or that documented adequate clean-out procedures are

used between production batches .

PhRMA has commented numerous times on the inadequacy of the 1997 feed ban (our

latest comments were provided to Federal Register Docket 2004N-0264 and dated

August 12, 2004). We stated that the current exemptions in the feed ban must be


http://www.defra.gov.uk/animalh/bse/science-research/pathog.html#dose


" Federal Register. Docket 20Gi2N-0273_ Vol. 70, No. 193 58570-58601 . Part IZi, Department of Health and Human Services, FDA 21CFR5$9 Subsianecs Prohlbired from Use ill Animal Food or Feed; Proposed Rule

Page 4 of 7

critically examined in light of the identification of BSE positive animals in Canada,

Washington, and subsequently in Texas. Over the last few years, PhRMA has urged

that serious consideration be given to prohibiting all specified risk material (SRM) in

rendered product used for non-ruminant feed due to the potential for "on farm" cross

contamination with feed designated for ruminants . We have strongly recommended

implementation of measures to ensure that SRM is excluded from all animal feed . In

addition, PhRMA urged the complete removal of the exception for ruminant blood and

the exemptions for plate waste and poultry litter from the ruminant feed ban. As such,

we strongly support the current FDA position to eliminate SRM from all animal feed and

urge its immediate implementation. This safeguard must be implemented rapidly.

Regrettably, FDA proposes to eliminate only the brain and spinal cord from cattle 30

months of age or older, not the complete list of SRMs currently designated for human

food . Given the absence of a species barrier when non-ruminant feed is fed

(inadvertently or deliberately) to ruminants, we urge the FDA to reconsider its position

and eliminate the complete list of SRM from all animal feed.

We are steadfast in our position urging the removal of the exemption for plate waste

and poultry litter . This position is based on the lack of species barrier and the inclusion

of tissues with potentially high levels of infectivity present in plate waste and poultry

litter . Allowing the exception for plate waste provides a direct route for feeding

ruminants to ruminants because plate waste may contain uneaten food items such as

T-bone steak waste, including bone innervated with dorsal root ganglia (DRG). The

absence of a species barrier when feeding ruminants to ruminants would facilitate the

transmission of infectivity by the demonstrated high titer DRG, if infectivity were

present . We have evaluated the rationale provide by FDA CVM for not banning plate

waste (in summary: SRMs are prohibited in human food therefore plate waste will not

contain SRMs and can be fed back to cattle). This rationale does not take into account

the lack of a species barrier when feeding cattle plate waste containing beef. The lack

Page 5 of 7

of a species barrier, coupled with the definition of SRMs limited to cows over 30 months

of age, combined with the knowledge that there is circulating BSE agent (albeit at

exceedingly low levels) in North America, are strong reasons to completely ban the

feeding of plate waste to bovines . In addition, the FDA states in the proposed rules that

they do not have an estimate of the amount of plate waste added to bovine feed, but

the available anecdotal information states that the amount is not significant. If there is

only a limited amount of plate waste being processed to bovine feed, given the lack of

species barrier, it appears logical to prohibit the use of plate waste completely. PhRMA

does not agree that eliminating all plate waste from bovine feed is an 'unnecessary

measure' and we strongly urge CVM to reevaluate its position.

Both specified risk materials (SRM) and plate waste are currently allowed in poultry

feed. We recommend that both SRM and plate waste be removed from poultry feed so

that poultry litter can be used as a bovine nitrogen source. If these materials are not

removed from poultry feed, then we recommend that poultry litter be banned from the

diet of cattle.

The proposed rule contains a provision to utilize certain dead cattle in animal feed.

Allowing deadstock (dead, down, disabled, diseased) into the animal food chain if the

brain and spinal cords have been removed does not take into account that these

animals are the most likely to harbor infectivity as symptoms of BSE disease confound

the segregation of these animals. The total amount of infectivity does not reside in the

brain and spinal cord and removal of these tissues does not make the remainder of the

carcass acceptable to process into animal feed . According to risk assessment models,

adult cattle deadstock are the population harboring the majority of the potential

Page 6 of 7

infectivity if BSE were! circulating in a population 3. Elimination of the deadstock from the

animal food chain is critical to prevent the spread of disease.

The other exemptions in the 1997 feed ban such as blood and milk/milk products are

less problematic as Iong as milk and blood are sourced to prevent cross-contamination

with high infiectivity tissues. We agree with the FDA's approach to these two tissues if

the potential for cross-contamination is minimized .

In summary, we recognize the tremendous efforts CVM has expended on defining a

strategy for enhanced feed controls in the United States to help stop the spread of

BSE. The thoughtful evaluation of all comments as a result of the publication of the

Advance Notice of Public Rule Making (July 14, 2004) reflects an Agency attempting to

balance the risks of continuing current feeding practices with the practical

considerations of various industries . We appreciate a risk based approach but have

misgivings about the level of safeguards contained in the proposed rule.

To reiterate, our main concerns center on the following three issues - the narrow

definition of the SRM to be excluded from non-ruminant feed, instead of a complete ban

as for ruminant feed; the continued allowance of plate waste and poultry litter in

ruminant feed and finally, the provision to allow certain deadstock cattle into the animal

food chain .

PhRMA appreciates the opportunity to comment on the proposed changes to the

ruminant feed ban and the implementation of controls on non-ruminant feed_ PhRMA

member companies manufacture human medicines using a wide variety of materials .

We continue to source animal derived raw materials according to regulations of FDA

Page 7 of 7

and the quality systems of the company. The United States must continue to be

recognized as an acceptable source of these animal derived raw materials both

domestically and by our international trading partners . Using sound science to

influence regulatory approaches to animal husbandry is the key to preventing the

spread of BSE in the United States. FDA and USDA have already done a lot to protect

the United States but more must be done as reflected in our comments herein . Please

contact me if you have any questions or would like to arrange a meeting to discuss our

comments.

Sincerely,

Marie A. Vodicka, PhD

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000534-01-vol45.pdf


Date: Fri, 20 Jan 2006 11:54:28 -0600
Reply-To: Bovine Spongiform Encephalopathy
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: Docket No: 2002N-0273 (formerly Docket No. 02N-0273) Substances
Prohibited From Use in Animal Food and Feed PAUL BROWN


##################### Bovine Spongiform Encephalopathy #####################


Subject: Docket No: 2002N-0273 (formerly Docket No. 02N-0273) Substances Prohibited From Use in Animal Food and Feed PAUL BROWN
Date: January 20, 2006 at 9:31 am PST

December 20,2005

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)

Substances Prohibited From Use in Animal Food and Feed

Dear Sir or Madame:

As scientists and Irecognized experts who have worked in the field of TSEs for

decades, we are deeply concerned by the recent discoveries of indigenous BSE infected

cattle in North America and appreciate the opportunity to submit comments to this very

important proposed rule We strongly supported the measures that USDA and FDA

implemented to protect public health after the discovery of the case of bovine spongiform

encephalopathy (BSE) found in Washington State in 2003. We know of no event or

discovery since then that could justify relaxing the existing specified risk material

(SRM) and non-ambulatory bans and surveillance that were implemented at that time.

Further, we strongly supported the codification of those changes, as well as additional

measures to strengthen the entire feed and food system. The discovery of additional

cases of indigenous BSE in North America since that time has validated our position and

strengthened OUT convictions.

We caution against using the 18 month enhanced surveillance as a justification to relax or

impede further actions. While this surveillance has not uncovered an epidemic, it does

not clear the US cattle herd from infection. While it is highly likely that US and

Canadian cattle were exposed to BSE prior to the 1997 feed ban, we do not know how

many cattle were infected or how widely the infection was dispersed. BSE cases are

most likely clustered in time and location, so while enhanced surveillance provides an 18

month snapshot, it does uot negate the fact that US and Canadian cattle were exposed to

BSE. We also do not know in any quantitative or controlled way how effective the feed

ban has been, especially at the farm level. At this point we cannot even make a thorough

assessment of the USDA surveillance as details such as age, risk category and regional

distribution have not been released.

A number of countries initially attempted to take partial steps in regard to feed controls

only to face repeated disappointments in predicted downturns of the epidemic course.

We in North America could do this experiment all over again, waiting for each new

warning before adding more stringency to our control measures, or we can benefit from

the experience of others and take decisive measures now to arrest any further

development of underlying cases that is implicit in those already discovered to date.

The discovery of 5 indigenous North American cases, including one born after the

implementation of the current feed ban, should provide the necessary incentive to

implement, monitor and enforce a comprehensive and protective feed ban that is more

congruent with the measures that have been proven to be effective throughout the world.

In particular, we urge the FDA to act without f&ther delay to strengthen the animal feed

regulations by implementing the program proposed by the Canadian Food Inspection

Agency (CFIA) in the December 11, 2004 Gazette. This includes removing all specified

risk materials (SRMs) and deadstock from all animal feed. We also urge that the FDA

discontinues the legal exemptions which allow ruminant protein to be fed back to

ruminants (with the excelption of milk). Many of these exemptions do not exist in other

countries.

Bovine products and byproducts are used for both food and pharmaceuticals. These

human uses require the highest level of safety. Because of the hardy nature of the BSE

agent and its high potential for cross contamination, the most effective way to protect

bovine products and bovine derived materials from contamination by BSE is to ensure

that infected animals or carcasses never enter processing plants. The goal would be to

discover and remove infected animals fi-om production as early as possible in the

infection and long before they wouid be sent to slaughter. Until we have diagnostic tools

powerful enough to allow us to discover the disease early in its prolonged pre-clinical

incubation, we have to rely on the next best strategy which is to prevent any exposure

through feed. The exemptions in the current ban as well as in the newly proposed rule

make this difficult if not impossible, as they still provide legal avenues for ruminants to

consume potentially contaminated ruminant protein.

It is our opinion that the Iproposed rule falls woetilly short in effective measures to

minimize the potential for further transmissions of the disease. By the FDA’s own

analysis, exempted tissues (such as distal ileum, DRGs, etc) contain approximately 10%

of the infectivity in affected animals. Thus the proposed rule still allows the possibility

for cattle to be exposed to BSE through:

1. Feeding of materials currently subject to legal exemptions from the ban (e.g.,

poultry litter, plate waste)

2. Cross feeding (the feeding of non-ruminant rations to runiinants) on farms; and

3. Cross contamination of ruminant and non-ruminant feed

We are most concerned that the FDA has chosen to include a provision that would allow

tissues from deadstock into the feed chain. We do not believe that down or dead stock

E-d

should be allowed into the food or feed chain whatever the age of the animal and whether

or not the CNS tissues are removed. We do not support the provision to allow removal of

brain and spinal cord from deadstock over 30 months for a number of reasons. This

category of animals contains the highest level of infectivity and that infectivity is in other

tissues besides just brain and spinal cord. Recent improvements in the BSE bioassay,

have now made it possible to detect BSE infectivity 1000 time more efficiently than

before. This assay has revealed the presence of BSE infectivity in some but not all

peripheral nerves and in one muscle. (Buschmann and Groschup, 2005) This published

and peer reviewed work is consistent with other publicly reported studies in Japan where,

by western blot testing, ,prions were found in the peripheral nerves of a naturally infected

94-month-old cow. We feel that the studies as reported above have merit. The current

studies not only re-etiorce the risk of down and deadstock but also appear to provide

additional information that these animals may be a potential source of greater levels of

infectivity into the feed .system. We also doubt that brain and spinal cord can be

completely removed especially during warmer weather. Given the biological

composition of these tissues, they are predisposed to rapid autolysis.

As world wide surveillance for BSE increases, several atypical cases of bovine TSE have

been discovered. These cases either show no clinical signs, or present as ‘downers’, and

have an atypical neuropathology with respect to lesion morphology and distribution,

causing problems in both clinical and post-mortem diagnosis. The origin of the cases are

unclear but they suggest that even should typical BSE be eliminated, there may be other

TSE diseases of cattle that could result by “mutation” and selection. Refeeding of

contaminated protein could potentially perpetuate transmission much like typical BSE.

An effective feed ban could prevent the expansion of such strains. We also note that

there are other species which are susceptible to BSE and the current regulations allow for

SRMs to be included in feed for these animals.

For BSE to be perpetuated, the animal production system must have a source of agent and

a means by which cattle or other susceptible species are exposed to this agent. We feel

that in North America, the source and routes of exposure still exist, hence allowing for

the continued recycling of BSE. We have detailed the scientific justifications for our

position below.

Source of the agent: SRMs (Specified Risk Materials) r

SRMs, as defined by the USDA, are tissues which, in a BSE infected animal, are known

to either harbor BSE i&:ctivity or to be closely associated with infectivity. If SRMs are

not removed, they may introduce BSE infectivity and continue tq provide a source of

animal feed contamination. For example, the skull and vertebral column which encase

the brain and spinal cord, respectively, can be assumed to have gross contamination.

Rendering will reduce infectivity but it will not totally eliminate it. This is significant as

research in the United Kilngdom has shown that a calf may be infected with BSE by the

ingestion of as little as AI01 gram of untreated brain.

The tissue distribution of infectivity in BSE infected cattle has primarily been determined

by 3 studies conducted in the United Kingdom all of which had limitations.

In two of the studies, bioassays were done in mice which are at least 1000 fold less

sensitive to BSE infection than cattle themselves. Only higher titers of infectivity can be

detected by this method. These investigations found infectivity in the brain, spinal cord,

retina, trigeminal ganglia, dorsal root ganglia, distal ileum and bone marrow (the bone

marrow finding was from one animal). Infectivity was found in distal ileum of

experimentally infected calves beginning six months after challenge and continuing at

other intervals throughout life. (Wells et. al., 1994; 1998). The bioassay study in calves

has produced similar results and in addition infectivity has been found in tonsil. The

study is still in progress. Another project has found infectivity in the lymphoid tissue of

third eyelid from naturally infected animals. (Dr. Danny Matthews, UK DEFRA,

personal communication).

While bioassay in cattle is far preferable to mice in terms of sensitivity, cattle

nevertheless present their own limitations in terms of the long incubation time and the

limited number of anim& that can be used for assay compared to rodents. As a

consequence the significance of the negative finding for many tissues is questionable. In

fact, by the end of 2004 there was increasing evidence in species other than cattle that

peripheral nerves and muscle have infectivity. (Bosque et al., 2002; Glatzel et al.,

2003;Bartz et al., 2002; Androletti et al., 2004; Mulcahy et al., 2004; Thomzig et al.,

2003; Thomzig et al., 2004)

In some of these species, studies indicate that the agent migrates to the brain and spinal

cord, replicates to high levels in the CNS and then spreads centrifugally from the spinal

cord back down through the spinal neurons to the junction of the nerves and muscle into

the muscle cells themselves. A recent German study (Buschmann and Groschup, 2005)

examined nerves and muscle from a cow naturally infected with BSE and found tbat

infectivity was present in several peripheral nerves and one muscle. The method of

detection was bioassay in bovinized transgenic mice that show the same or greater

sensitivity to transmission of BSE as cattle. This research concurs with findings by

Japanese scientists that BSE infectivity is present in peripheral nerves at least in the

clinical stage of disease.

It is our opinion that there is increasing evidence that the pathogenesis of BSE might not

be entirely different from TSEs in other species at the point of clinical disease in that

there is peripheral involvement. We feel that the studies as reported above have merit.

The current studies not only re-enforce the risk of down and deadstock but also appear to

provide additional information that these animals may be a potential source of greater

levels of infectivity into the feed system.

In the event that FDA may confer with USDA about the risks associated with peripheral

nerves we want to point out one issue. In the recent publication of the final rule on the

SSOI-Z6L.-ZEL

importation of whole cuts OF boneless beef from Japan, 9 CFR Part 94 [Docket No. 05-

004-21 RIN 0579-AB93, we disagree with the interpretation provided by USDA, APHIS.

APHIS seems to discount the studies conducted by Groschup et al. 2005. on the basis that

the transgenic mouse bioassay that they used may be too sensitive. In taking this position

they have failed to realize that the point oFan assay is to reveal in which tissues the

infectivity resides and its relative concentration to brain or spinal cord. For this purpose,

no assay can be too sensitive. Of course, the probability of an actual infection will he

affected by the efficiency of infection which will be a function of dose, route of exposure

and any host barrier effects that are present.

We would also like to point out a factual error in the conclusion. APHIS states, “Given

these factors, APHIS has determined that the finding of l3SE infectivity in facial and sciatic nerves

of the transgenic mice is nalt directly applicable to cattle naturally infected with BSE. Therefore,

we do not consider it necessary to make any adjustments to the risk analysis for this rulemaking

or to extend the comment Fleriod to solicit additional public comment on this issue.” It is incorrect

that the infectivity was found in the peripheral nerves of transgenic mice. The peripheral

nerves were harvested from a cow naturally infected with BSE. Transgenic mice were

used as a bioassay model.

From [Docket No. 05-004-21 RIN 0579-AB93:

“Peripheral Nerves

Issue: Two commenters stalted that the underlying assumption of the proposed rule. that whole

cuts of boneless beef from #Japan will not contain tissues that may carry the BSE agent, is no

longer valid because researchers have found peripheral nervous system tissues, including facial

and sciatic nerves, that contain BSE infectivity.U One of these commenters requested API-W to

explain whether and what additional mitigation measures are needed to reduce the risks that

these tissues may be present in Japanese beef. This commenter further requested an additional

comment period to obtain public comments to treat this new scientiic finding.

\2\ Bushmann, A., and Groschup, M.; Highly Bovine Spongiform

Encephalopathy-Sensitive Transgenic Mice Confirm the Essential

Restriction of Infectivity to the Nervous System in Clinically

Diseased Cattle. The Journal of Infectious Diseases, 192: 93442,

September 1, 2005.

Response: APHIS is familiar with the results of the study mentloned by the commenters in which

mice, genetically engineered to be highly susceptible to BSE and to overexpress the bovine prion

protein, were inoculated with tissues from a BSE-infected cow. This study demonstrated low

levels of infectivity in the mouse assay in the facial and sciatic nerves of the peripheral nervous

system. APHIS has evaluated these findings in the context of the potential occurrence of

infectivity in the peripheral nerves of cattle and the corresponding risks of the presence of

infectivity in such tissues resulting in cattle or human exposure to the BSE agent. The results

from these experiments in genetically engineered mice should be interpreted with caution, as the

findings may be influenced by the overexpression of prion proteins and may not accurately

predict the natural distribution of BSE infectivity in cattle. Further, the overexpression of priori

s-d

proteins in transgenic mice may not accurately mimic the natural disease process because the

transgenic overexpressing mice have been shown to develop spontaneous lethal neurological

disease involving spongifolrm changes in the brain and muscle degeneration.\3\ In addition, the

route of administration to the mice was both intraperitoneal and intracerebral, which are two very

efficient routes of infection as compared to oral consumption. Given these factors, APHIS has

determined that the finding of BSE infectivity in facial and sciatic nerves of the transgenic mice is

not directly applicable to cattle naturally infected with BSE. Therefore, we do not consider it

necessary to make any adjustments to the risk analysis for this rulemaking or to extend the

comment period to solicit additional public comment on this issue.”

Source of the agent: Deaalstock

The total amount of TSE infectivity in a TSE infected animal increases steadily

throughout the infection and exponentially once the infectivity reaches the brain.

Infected individuals only exhibit recognizable clinical signs once infectivity titers have

reached high levels in the brain. Surveillance data collected throughout Europe indicates

there is a much greater likelihood for BSE to be detected in dead or down cattle than

from healthy normal animals. This has so far also been borne out by the experience in

North America. Animals that die of BSE harbor the greatest amount of agent that can be

produced by the disease. Leaving the tissues from the highest risk category of cattle in

the animal feed chain will effectively nullify the purported intent of this regulation. This

point is supported by the 2001 Harvard risk assessment model that demonstrated that

eliminating dead and downer, 4D cattle, from the feed stream was a disproportionately

effective means of reducing the risk of re-infection.

“The disposition of cattle thot die on the farm would also huve a substantial influence on

the spread of BSE if the disease were introduced ” The base case scenario showed that

the mean rota? number oj’IDS0.s (i.e., dosage suficient to infecf 50percent of exposed

cattle) f;om healthy animals at slaughter presented to the foodfeed system was 1500.

The mean total number yf IDSOsfiom adult cuttle deadstockpresented fo the feed system

was 3 7,000. This illustrates the risk of “40 cattle ” (i.e.. deadstock).

From the Harvard Risk Assessment, 200 1, Appendix 3A Base Case and Harvard Risk

Assessment, 200 1 Executive Summary

It is likely that these numbers would have to be adjusted upwards, if the UK attack rate

and Groschup data were considered.

Inflammation and TSErr

There have been 3 recent peer reviewed publications which indicate that chronic

ir&unmatory conditions in a host with a TSE may induce priori replication in, or

distribution to organs previously thought to be low or no risk. They are as follows:

s-d

1 _ Chronic Lymphocytic Inflammation Specifies the Organ Tropism of Prions

(Heikenwalder et. al. 2005 >~xx .sci~:n~c\rpl-css.~~r~/~O .lunuarv 2005/ Parrc l/

&).I 1zois~icllcc.l lOh4hO)

2. Coincident Scrapie Infection and Nephritis Lead to Urinary Priori Excretion

(Seeger et al., Science 14 October 2005:Vol. 310. no. 5746, pp. 324 - 326

DOI: lO.l126/science. 1118829)

3. PrPS” in mammary glands of sheep affected by scrapie and mastitis (Ligios C., et

al. Nature Medicine, 11. 3 137 - 1138, 2005)

These studies from the Aguzzi laboratory warn that concurrent chronic inflammatory

disease could dramatically alter the distribution of BSE infectivity in infected cattle.

Down and dead stock are at higher risk for both BSE and other systemic conditions. If

the results reported above are also applicable to cattle, the carcasses of dead and down

stock affected by BSE might contain even higher levels of infectivity, or contribute

infectivity via tissues thai. are not ordinarily at risk in normal animals.

Exposure: tndustry Practices or Exemptions which may pose a risk

Poultry Litter

In the United States poultry litter can be fed to cattle. There are two potential sources of

risk from poultry litter. Poultry litter not only consists of digested feed but also of feed

which spills from the cages. As a consequence, the practice of feeding litter back to

cattle is by its nature non--compliant with the current feed ban if the poultry themselves

are being fed ruminant protein. Given that ruminant protein can no longer be fed to

ruminants in the United States and that most. if not all. countries will no longer import

North American ruminant MBM, an even larger part of poultry diets is now ruminant

MBM. Spillage provides a direct link to back to cattle but feces are also likely to contain

infectivity.

There is no reason to expect that TSE infectivity would be inactivated by passage through

the poultry gut, and only a slim possibility that composting would reduce infectivity at

all. Thus poultry feces are another potential route of transmission back to cattle.

Evidence for this comes from rodent experiments where infectivity was demonstrated in

the feces after being fed: “Laboratory experiments show that mice orally challenged with

scrapie have detectable infectivity that passes through the gut. Gut contents and fecal

matter may therefore contain infectivity, and it is noted that in experimental oral

challenges in cattle conducted in the UK, feces must be treated asamedical waste for one

month following the challenge. It is concluded that digestive contents and fecal material

from livestock or poultry currently being fed with MBM potentially contaminated with

BSE should not be used a.s a feed ingredient for animal feed.” [Proceedings: Joint

WHO/FAO/OIE/ Technical Consultation on BSE: public health, animal health and

trade. Paris, lo-14 June 2001; and Alan Dickinson, personal communication].

It may be possible to remove the risk from poultry litter by sterilization. However, unless

or until a method can be developed and validated, poultry litter should be banned from

ruminant feed.

Ruminant Blood

In contrast with humans, sheep, monkeys, mice and hamsters, including sheep and mice

infected with BSE and humans infected with vCJD considered identical to BSE, no

infectivity has so far been demonstrated in the blood of BSE infected cattle. However,

we consider it unlikely that cattle are the sole outlier to what has been a consistent finding

in all other TSE diseases where the measurement has been made with sufficient

sensitivity to detect the low levels of infectivity that are present in blood. Rather, this

failure is more likely the result of the very small volumes of blood that were used for the

inoculations (less than 1 ml), whereas whole transfusions were administered to assay

animals in the published .sheep scrapie/BSE experiments. If blood is infected then all

vascularized tissues can bc expected to contain some infectivity in proportion to the

content of residual blood..

Micro emboli are a possible source of blood-borne agent that could be at much higher

titer than blood itself, in slaughtered cattle carrying BSE infection. Stunning can release

micro emboli of brain tissue into the circulatory system from where they can be

distributed to other tissues in the few moments before the exsanguination and

death. (Anil, et al, 2001a & b; Anil et al, 2002; Love, et al, 2000). This source of

infection couid extend a higher infectivity risk to tissues that would otherwise be at low

risk, thereby allowing exposure of cattle through any of the legal exemptions and

potentially producing a feed and food risk. Blood-borne contamination may be a special

problem where spray-dried blood is being used as a milk replacer for calves, as it is

thought that young animals are especially susceptible to infection.

Certainly, blood and bloald proteins should not be used as feed without conclusive

evidence that they are saf’e.

Unfiltered Tallow

Ruminant tallow is exempted from the current feed ban. Tallow contains protein

impurities (i.e. MBM) that could be a source of TSE infectivity. There are no impurity

level requirements for this tallow. It has been reported that it is standard practice to

produce tallow which has an impurity level of _ 15% or below, but it is not clear that this

is fully adequate to remove the risk of transmission and there is no requirement to meet

even this standard. We urge that protein contaminants be excluded from tallow and that

SRMs also be removed.

6-d

Plate Waste

Plate waste is not limiteld to meat (muscle tissue). For example, cuts that include a

portion of the spinal cor’d or that are contaminated by cord or ganglia during preparation

could contain high levels of infectivity if derived from a TSE infected animal late in the

preclinical stage of infection. At best this material would only be exposed to normal

cooking temperatures. USDA, APHIS experience with the Swine Health Protection Act

has revealed that plate waste also includes uncooked trimmings and bones. Although the

current FDA regulation requires the plate waste be treated again, there are no

specifications which would render a TSE agent inactive. Of greatest risk would be any

bovine source of infectivity but also sheep scrapie, although not known to be a risk for

human consumption, is one of the possible origins of BSE. The sheep scrapie agent is

known to be widely dispersed including relatively high titers in lymphoid as well as

nervous tissue. We support the USDA’s opposition to the exemption of “plate waste” as

stated in written comments since 1997.

Exposure: Cross Feeding and Cross Contamination

The UK epidemiology has clearly shown that BSE contaminated feed is the primary if

not sole vehicle for the transmission of BSE between cattle. Moreover, results from the

United Kingdom’s attack: rate study indicate that it does not take much exposure to

transmit BSE to cattle. FLecent results from the attack rate study which is still in progress

have found that _ 1 g of brain transmitted BSE by the oral route to 3 cows out of 15 thus

far, and .Ol and .OOl gr of brain have transmitted BSE (1 cow out of 15). (Danny

Matthews, DEFRA presentation at TAFS meeting, Washington, DC April 2004).

Rendering may reduce infectivity but it does not eliminate it. (Taylor et al, 1995; Taylor

et al, 1997; Schreuder et al, 1998). Given that BSE can be transmitted to cattle via an

oral route with just .OO 1 gram of infected tissue, it may not take much infectivity to

contaminate feed and kee:p the disease recycling. This is especially true in countries like

the US and Canada which do not have dedicated lines and equipment to manufacture and

process feed for ruminants and non-ruminants.

In addition, epidemiological investigations in European countries have shown that cross

feeding and cross contamination on farm can be a significant vehicle for continued BSE

transmission even after feed bans are well established. Cross feeding is the practice of

feeding meal for poultry or pigs or pet food (which can legally contain ruminant MBM)

to cattle on the same farm. This is usually due to simple human error or negligence.

(Hoinville, 1994; Hoinville et al, 1995; Doherr et al, 2002% Stevenson et al, 2000)

FDA, CVM reports that compliance with the existing feed ban is high. For the most part

this does not include the compliance level on the farm. There are hundreds of thousands

of farms in the US. Many of these have multiple species- That is, they raise cattle, pigs,

chickens etc., on the same premises. The sheer numbers of farms make it very difficult to

assure compliance on farm and to adequately cover all farms by inspection- Even if the

rendering industry and feed industry can maintain 100% compliance at their facilities, if a

producer inadvertently feeds chicken feed containing bovine MBM to their cattle, they

negate a perfect compliance rate higher in the chain. Recent data from the Harvard BSE

risk assessment suggest that the level of misfeeding on farms plays a significant role in

the ability of the agent to recycle. In fact George Gray, principal investigator for the

study, stated that if, in the United States, misfeeding were to occur at a level of 15%, the

RO would be over 1, indicating that the BSE level would not be declining. (George Gray

presentation at the Meeting on BSE Prevention in North America: An Analysis of the

Science and Risk; January 27,2005, Washington, DC.)

The May 2003 Canadian BSE case illustrates the difficulty of on farm enforcement and

its serious ramifications. The BSE positive cow was rendered and the MBM distributed

to various locations. Two of these locations were poultry farms which mixed their own

feed. The farms also had cattle. The subsequent investigation could not eliminate the

possibility that the cattle had been fed the same feed as the poultry. The cattle on these

farms were completely depopulated.

Human error is extremel:y difftcult to prevent, and managing the risk through

enforcement is problematical when confronted with the extreme logistical challenges of

on farm monitoring. By eliminating the highest risk materials (SRMs and deadstock)

which could introduce infectivity into the feed stream, the MBM resulting from

processing becomes inherently safer. If mistakes are then made on farm, they no longer

contribute to the recycling of BSE.

Exposure: Susceptibility of other Species

Felines

A transmissible spongifoim encephalopathy has been diagnosed in eight species of

captive wild ruminants as well as exotic felines (cheetahs, pumas, a tiger and an ocelot)

and domestic cats (Wyatt 1991). There have been over 80 domestic cat cases of Feline

Spongiform Encephalopathy (FSE) in Great Britain, and cats in Norway, Northern

Ireland, Lichtenstein and Switzerland. The agent isolated from several of these cases is

indistinguishable from BSE in cattle using strain typing in mice, duggesting that FSE is

actually BSE in exotic and domestic cats. Epidemiological evidence suggests BSE

contaminated feed to be the probable source of infection in these species. (MAFF

Progress Report, June 1997), thus providing additional supporting evidence for the

dangers of BSE contaminated feed and reinforcing the necessity of removing all sources

of potential contamination from the feed stream

Other species

Studies conducted at the National lnstitutes of Health Rocky Mountain Laboratory

caution against assuming that animals which do not become clinically ill are not infected.

It is unknown if certain animals may become carriers, i.e., become infected, shed agent

but do not progress to clinical disease. Infection of certain rodent species with different

TSE strains suggests the possibility of a carrier state (Race and Chesebro, 1998; Race et.

al, 2001, Race et al., 2002). In the more recent studies, mice were inoculated with 263K

hamster scrapie. There was a prolonged period (approximately one year) where there was

no evidence of replication of infectivity. Furthermore, there was no evidence of PrPres

during this phase of inactive persistence, which was followed by a period of active

replication of infectivity and agent adaptation. In most cases, PrPres was not detected in

the active phase as well. It is important to determine if this persistence and adaptation

occurs in other species exposed to TSEs as it may have significance in feeding programs

which continually expose other species to BSE infectivity. For example, if BSE infected

brain and spinal cord are continually fed to certain species, it may be possible for the

agent to persist and adapt in these new species. Over time, the ‘resistant’ species may

become a source of agenl. The results of Race and colleagues, warns that an inactive

persistent phase might not produce detectable PrPres, yet there would be infectivity (Race

et. al., 2001).

Pigs displayed evidence of TSE infection after exposure to BSE by 3 distinct parer&ml

routes. Evidence of infectivity was found in the CNS, stomach, intestine and pancreas

(Dawson et. al., 1990). CIral transmission has also been attempted in swine, but after an

observation period of 84 months there was neither clinical nor pathological evidence of

infection (Dawson et. al., 1990). Parenteral and oral transmission has also been

attempted in chickens with no evidence of disease. Tissues from the BSE-challenged

pigs and chickens were inoculated into susceptible mice to look for residual infectivity,

but to date none has been found. In both instances the detection sensitivity was limited

by the use of mice for bioassay instead of same species transmissions into cattle (or pigs

and chickens).

If any of these scenarios played out and inapparent infections became established in

commercial species, those species could become reservoirs for reinfection of cattle and

perpetuation or reintroduction of the epidemic. We also do not know if atypical cases of

BSE are more pathogenic for other species and if chronic inflammation may influence the

susceptibility of other species. We offer these possibilities to reitiorce the need to

eliminate all possible sources of infectivity from the feed stream.

In January 2005, the European Union announced that BSE had been confirmed in a goat

in France illustrating that the disease can be naturally transmitted to one of the small

ruminants. The potential ramifications of this and the logistical chaIlenges associated

with controlling BSE in sheep or goats also provides a justification for removing SRMs

from all animal feed. Although these species are covered under the current regulations

the cross contamination and cross feeding aspects stated for cattle are applicable.

The need to remove high risk material from all animal feed is also supported by other

bodies with expertise in the field of TSEs:

Recommendations of the World Health Organization (WHO)

The World Health Organization (WHO) has issued the following recommendations for

countries with BSE or those where a known exposure exists:

l No part or product of any animal which has shown signs of a TSE should enter any

food chain (human or animal). In particular:

o All countries must ensure the killing and safe disposal of all parts or products

of such animals so that TSE infectivity cannot enter any food chain.

o Countries sholuld not permit tissues that are likely to contain the BSE agent to

enter any food chain (human or animal).

From the report of a WHO Consultation on Public Health Issues related to Human and

Animal Transmissible Spongiform Encephalopathies WHO/EMC/DIS 96.147, Geneva,

2-3 April 1996.

Office of International El-

The OIE is recommendinlg that a list of SRMs which include brain, spinal cord, eyes,

skull and vertebral column be removed from preparations used for food, feed, fertilizer,

etc. If these tissues sholtld not be traded we feel that they should not be used in domestic

products either.

BSE Code Article 2.3.13.18

“From cattle, originating from a country or zone with a minimal BSE risk, that were at the time of

slaughter over 30 months of age, the following commodities, and any commodity contaminated by them,

should not be traded for the preparation of Food, feed, fertilizers, cosmetics, pharmaceuticals including

biologicals, or medical device:s: brains, eyes and spinal cord, skull, vertebral column and derived protein

products. Food, feed, fertilizers, cosmetics, pharmaceuticals or medical devices prepared using these

commodities should also not be traded.”

Conclusion

In conclusion we urge the: FDA to implement, monitor and enforce a comprehensive and

protective feed ban that is more congruent with the measures that have been proven to be

effective in other countries that have experienced BSE. 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.

We also wish to emphasize that as scientists who have dedicated substantive portions of

our careers to defining the risks from TSEs as well as developing strategies for managing

those risks, we are confident that technical solutions will be found for many of the

challenges posed by these diseases. Thus, we urge the FDA to frame its regulations in

terms that allow for the future use of any banned material if it can be proven safe for a

given application.

El-d

Signatories:

Paul W. Brown, M.D.

Medical Director, USPH[S, and Senior Investigator, NIH (retired)

Consultant, TSE Risk Management

78 15 Exeter Rd.

Bethesda, MD 208 14

Fax 301-652-43 12

Email: paLII\\ hr-c~~~rl~~/‘~c)m~as~.rlct -----

Neil R Cashman MD

Professor, Department 0-C Medicine (Neurology)

Diener Chair of Neurode:generaGve Diseases

Centre for Research in Neurodegenerative Diseases

6 Queen’s Park Crescent West

Toronto Ontario M5S3H2

Ph: 416-978-1875

Fax: 4 16-978- 1878

e-mail: neil.cashman@utoronto.ca

Linda A. Detwiler, DVM

Consultant, TSE Risk Management

225 Hwy 35

Red Bank, NJ 07701

Ph 732-74 l-2290

Fax 732-741-775 1

Email: l.~\Vc~92’rr’ac,l.c0111.

Laura Manuelidis, MD

Professor and Head of Neuropathology,

Department of Surgery and Faculty of Neurosciences

Yale Medical School

333 Cedar St.

New Haven, CT 065 10

email: I~IL~ra.~~~ar~clclirli~~~~~~alc.cdi~

Tel: 203-785-4442

Jason C. Bar-k, Ph.D.

Assistant Professor

Department of Medical Microbiology and Immunology

Creighton University

2500 California Plaza

Omaha, NE 68178

(402) 280- 18 11 voice

(402) 280-l 875 fax

jbartz@creighton .edu

Robert B. Petersen, Ph.D.

Associate Professor of Pathology and Neuroscience

Case Western Reserve University

5- 123 Wolstein 13~1ilding

2 103 Cornell Road

Cleveland, OH 44 106-26122

Phone 216-368-6709

FAX 360-838-9226

Email rhp~,-c\\~~.c~!t~

Robert G. Rohwer, Ph.D.

Director, Molecular Neurovirology Laboratory

Veterans Affairs Medicall Center

Medical Research Service 151

Assoc. Professor of Neurology

School of Medicine

University of Maryland ;at Baltimore

10 N. Greene St.

Baltimore, MD 21201

ph. 4 1 O-605-7000 x6462

Fax 4 1 o-605-7959

email: rrohwer@maryland.edu

REFERENCES

Andreoletti 0, Simon S, Lacroux C, Morel N, Tabouret G, Chabert A, Lugan S, Corbiere

F, Ferre P, Fouc,ras G, Laude H, Eychenne F, Grassi J, Schelcher F. PrPSc accumulation

in myocytes from sheep incubating natural scrapie. Nat Med. 2004 Jun;10(6):591-3.

Epub 2004 May 23.

Ani1,M.H.; Love,S.; Hr:lps,C.R.; McKinstry.J.L.; Brown,S.N.; Philips,A.; Williams,S.;

Shand,A.; Baki.rel,T.; Harbour,D.A. - Jugular venous emboli of brain tissue induced in

sheep by the use of captive bolt guns - Veterinary Record 2001 May 19; 148: 619-20

Ani1,M.H.; Harbour,D.A. - Current stunnin g and slaughter methods in cattle and sheep.

Potential for carcass contamination with central nervous tissue and microorganisms -

Fleischwirtschaft 200 1; 11: 123

Ani1,M.H.; Love& He:lps,C.R.; Harbour,D. - Potential for carcass contamination with

brain tissue following stunning and slaughter in cattle and sheep - Food Control 2002; 13:

431-6

Bartz JC, Kincaid AE, IBessen RA. Retrograde transport of transmissible mink

encephalopathy within (descending motor tracts. J Virol. 2002 Jun;76(11):5759-68.

Bosque PJ, Ryou C, Telling G, Peretz D, Legname G, DeArmond SJ, Prusiner SB.

Prions in skeletal muscle. Proc Nat1 Acad Sci U S A. 2002 Mar 19;99(6):3812-7.

Bushmann, A., and Groschup, M.; Highly Bovine Spongiform Encephalopathy-Sensitive

Transgenic Mice Confilm the Essential Restriction of Infectivity to the Nervous System

in Clinically Diseased Cattle. The Journal of Infectious Diseases, 192: 934-42, September

1,2005.

Dawson,M.; Wells,G.A.H.; Parker,B.N.; Scott,A.C. - Primary parenteral transmission of

bovine spongiform encephalopathy to the pig - Veterinary Record 1990 Sep 29; 127( 13):

338

Doherr,M.G.; Hett,A.R.; Rufenacht,J.; Zurbriggen,A.; Heim,D. - Geographical clustering

of cases of bovine spongiform encephalopathy (BSE) born in Switzerland after the feed

ban - Veterinary Record 2002 Ott 19; 15 1(16): 467-72

Glatzel M, Abela E, Ma.issen M, Aguzzi A. Extraneural pathologic prion protein in

sporadic Creutzfeldt-Jakob disease. N Engl J Med. 2003 Nov 6;349(19): 1812-20.

Hadlow W. J., Kennedy R. C. & Race R. E. (1982) Natural infection of Suffolk sheep

with Scrapie virus. J. hfect. Dis., 146, 657-664

Hoinville,L.J. - Decline in the incidence of BSE in cattle born after the introduction of the

‘feed ban’ - Veterinary IRecord 1994 Mar 12; 134( 11): 274-5

Hoinville,L.J.; Wi1esmithJ.W.; Richards,M.S. - An investigation of risk factors for cases

of bovine spongiform encephalopathy born after the introduction of the ‘feed ban’ -

Veterinary Record 199.5 Apr 1; 136( 13): 3 12-8

Houston,E.F.; Foster,J.D.; Chong,A.; Hunter,N.; Bostock,C.J. - Transmission of BSE by

blood transfusion in sheep - Lancet 2000 Sep 16; 356(9234); 999-l 000

Hunter,N.; Foster,J; Chong,A.; McCutcheon,S.; Parnham,D.; Eaton,S.; MacKenzie,C.;

Houston,E.F. - Transmission of prion diseases by blood transfusion - Journal of General

Virology 2002 ‘Nov, 83(Pt 11); 2897-905.

Love,S.; Helps,C.R.; Williams,S.; Shand,A.; McKinstry,J.L.; Brown,S,N.; Harbour,D.A.;

Ani1,M.H. - Methods for detection of haematogenous dissemination of brain tissue after

stunning of cattle with captive bolt guns - Journal of Neuroscience Methods 2000 Jun 30;

99( l-2): 53-8

Mukahy ER, Bar-& JC, Kincaid AE, Bessen RA. Priori infection of skeletal muscle cells

and papillae in the tongue. .J Viral. 2004 Jul;78(13):6792-8.

Race, R.; Chesebro, B. - Scrapie infectivity found in resistant species. Nature -1998 Apr

23;392(6678):770.

Aguzzi,A.; Weissmann,C. - Spongiform encephalopathies. The priori’s perplexing

persistence. - Nature. 1998 Apr 23;392(6678):763-4

Race,R.E.; Raines,A.; Raymond,G.J.; Caughey,B. W.; Chesebro,B. - Long-term

subclinical carrier state precedes scrapie replication and adaptation in a resistant species:

analogies to bovine spongiform encephalopathy and variant Creutzfeldt-Jakob disease in

humans. - Journal of V:irology 2001 Nov; 75(2 1): 10106-l 2

Race,R.E.; Meade-White&; Raines,A.; Raymond,G.J.; Caughey,B.W.; Chesebro,B. -

Subclinical Scrapie Infkction in a Resistant Species: Persistence, Replication, and

Adaptation of Infectivity during Four Passages. - Journal of Infectious Diseases 2002 Dee

1; 186 Suppl2: S166-70

Schreuder, B.E.C., Geertsma, R.E., van Keulen, L.J.M., van Asten, J.A.A.M., Enthoven, P.,

Oberthiir, R.C., de Koeijer, A.A., Osterhaus, A.D.M.E., 1998. Studies on the effkacy of

hyperbaric rendering procedures in inactivating bovine spongiform encephalopathy (BSE) and

scrapie agents. Veterinary Record I42,474-480

Stevenson, M. A., Wilesmith, J. W., Ryan, J. B. M., Morris, R.S., Lockhart, J. W., Lin,

D. & Jackson, R. (2000) Temporal aspects of bovine spongiform encepalopathy in Great

Britain: individual animal-associated risk factors for the disease. Vet. Rec. 147, 349-354.

Stevenson, M. A., Wilesmith, J. W., Ryan, J. B. M., Morris, R. S., Lawson, A.B.,

Pfeiffer, D. U. & Lin, D. (2000) Descriptive spatial analysis of the epidemic of bovine

spongiform encephalopalthy in Great Britain to June 1997. Vet. Rec. 147,379-384.

Taylor, D.M., Woodgate, !S.L., Atkinson, M.J., 1995. Inactivation of the bovine spongiform

encephalopathy agent by rendering procedures. Veterinary Record, Vol.1 37: pp.605-610.

Taylor, D.M., Woodgate, S-L., Fleetwood, A.J., Cawthome, R.J.G., 1997. The effect of rendering

procedures on scrapie agent. Veterinary Record, Vol. 141, pp 643-649.

Thornzig A, Schulz-Schaeffer W, KratzeI C, Mai J, Beekes M. Preclinical deposition of

pathological prion protein PrPSc in muscles of hamsters orally exposed to scrapie.

J Clin Invest. 2004 May; 113( 10): 1465-72.

Thomzig A, Kratzel C, Lenz G, Kruger D, Beekes M. Widespread PrPSc accumulation

in muscles of hamsters orally infected with scrapie. EMBO Rep. 2003 IUay;4(5):530-3.

Wilesmitb, J.W., Ryan, J. B. M., Hueston, W. D., & Hoinville, L. J. (1992) Bovine

spongifozm encephalopathy: epidemiological features 1985 to 1990. Vet. Rec., 130,90-

94.

Wilesmith, J. W., Wells, G. A. H., Ryan, J. B. M., Gavier-Widen, D., & Simmons, M. M.

(1997) A cohort study to examine maternally associated risk factors for bovine

spongiform encephalopathy. vet. Rec., 141,239-243.

Wells G.A.H., Dawson h/Z., Hawkins, S-A-C., Green R. B., Dexter I., Francis M. E.,

Simmons M. M., Austin A. R., & Horigan M. W. (1994) Infectivity in the ileum of

cattle challenged orally with bovine spongiform encephalopathy. Vet. Rec., 135,40-41.

Wells G.A.H., Hawkins, S.A.C., Green R. B., Austin A. R., Dexter I., Spencer, Y. I-,

Chaplin, M. J., Stack, M. J., & Dawson, M. (1998) Preliminary observations on tbe

pathogenesis of experimental bovine spongiform encephalopathy (BSE): an update. Vet.

Rec., 142, 103-106.

Wyatt. J. M. et al. 1991. INaturally occurring scrap&like spongiform encephalopathy in

five domestic cats. Veterinary Record. 129. 233.


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf


December 19, 2005

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)

Substances Prohibited From Use in Animal Food and Feed

Dear Sir or Madame:

The McDonald’s Corporation buys more beef than any other restaurant in the United States. It is

essential for our customers and our company that the beef has the highest level of safety.

Concerning BSE, the most effective way to insure this is to create a system that processes cattle

that are not exposed to the disease. As a company we take numerous precautions via our strict

specifications to help and assure this, however we feel that the force of federal regulation is

important to ensure that the risk of exposure in the entire production system is reduced to as

close to zero as possible. The exemptions in the current ban as well as in the newly proposed rule

make this difficult if not impossible, as there are still legal avenues for ruminants to consume

potentially contaminated ruminant protein. In addition, the USDA still has not implemented a

system of identification and traceability. It is our opinion that the government can take further

action to reduce this risk and appreciate the opportunity to submit comments to this very

important proposed rule.

After the identification of bovine spongiform encephalopathy (BSE) in indigenous North

American cattle, the U.S. Department of Agriculture (USDA) responded rapidly to implement

measures to protect public health in regard to food. Our company recognizes and supports the

importance of the current feed ban which went into effect in August 1997. However, given what

is known about the epidemiology and characteristically long incubation period of BSE, we urge

the FDA to act without further delay and implement additional measures which will reduce the

risk of BSE recycling in the US cattle herd. We caution against using the 18 month enhanced

surveillance as a justification to relax or impede further actions. While this surveillance

indicates an epidemic is not underway, it does not clear the US cattle herd from infection. The

positive cases indicate probable exposure prior to the 1997 feed ban, a time when BSE appears to

have been circulating in animal feed. BSE cases are most likely clustered in time and location,

so while enhanced surveillance provides an 18 month snapshot, it does not negate the fact that

US and Canadian cattle were exposed to BSE and that the current feed controls contain “leaks”.

We feel that for the FDA to provide a more comprehensive and protective feed ban, specified

risk materials (SRMs) and deadstock must be removed from all animal feed and that legal

exemptions which allow ruminant protein to be fed back to ruminants (with the exception of

milk) should be discontinued.

SRMs, as defined by the USDA, are tissues which, in a BSE infected animal, are known to either

harbor BSE infectivity or to be closely associated with infectivity. If SRMs are not removed,

they may introduce BSE infectivity and continue to provide a source of animal feed

contamination. Rendering will reduce infectivity but it will not totally eliminate it. This is

significant, as research in the United Kingdom has shown that a calf may be infected with BSE

by the ingestion of as little as .001 gram of untreated brain.

The current proposed rule falls short of this and would still leave a potential source of infectivity

in the system. In fact by the FDA’s own statement the exempted tissues which are known to

have infectivity (such as distal ileum, DRGs, etc) would cumulatively amount to approximately

10% of the infectivity in an infected animal. Leaving approximately 10% of the infectious

tissues in the system is not good enough. The proposed rule still allows the possibility for cattle

to be exposed to BSE through:

1. Feeding of materials currently subject to legal exemptions from the ban (e.g., poultry

litter, plate waste)

2. Cross feeding (the feeding of non-ruminant rations to ruminants) on farms; and

3. Cross contamination of ruminant and non-ruminant feed

We are most concerned that the FDA has chosen to include a provision that would allow tissues

from deadstock into the feed chain. We do not support the provision to allow the removal of

brain and spinal cord from down and deadstock over 30 months of age for several reasons.

These are the animals with the highest level of infectivity in tissues which include more than

brain and spinal cord. Firstly, there are two issues regarding the complex logistics of this option.

We do not feel that it is possible to have adequate removal especially during the warmer months.

In addition, we do not feel that there are adequate means to enforce complete removal. Unlike

slaughterhouses, there are no government inspectors at rendering plants or deadstock collection

points.

Most importantly, there is emerging information that at end stage disease (a natural BSE case);

infectivity may also be included in additional tissues such as peripheral nerves (Buschmann and

Groschup, 2005 – see attached). This published work supports publicly reported studies in Japan

where by western blot testing, prions have been found in the peripheral nerves of a naturally

infected 94-month-old cow. If this is the case, the amount of infectivity left in the system from

an infected bovine would surpass 10% and the full extent is still unknown.

McDonald’s has convened it own International Scientific Advisory Committee (ISAC) as well as

co-sponsored a symposium of TSE scientists on the issue of tissue distribution. The consensus

of both groups was that the pathogenesis of BSE might not be entirely different from TSEs in

other species at the point where the animal is showing signs of the disease. These scientists feel

that the studies as reported above have merit. The current studies not only re-enforce the risk of

down and deadstock but also appear to provide additional information that these animals may be

a potential source of greater levels of infectivity into the feed system. Hence, we suggest that the

FDA consult with TSE scientists as well.

Leaving the tissues from the highest risk category of cattle in the animal feed chain will

effectively nullify the intent of this regulation. This point is illustrated by the 2001 Harvard risk

assessment model that demonstrated that eliminating dead and downer, 4D cattle, from the feed

stream was a disproportionately effective means of reducing the risk of re-infection.

“The disposition of cattle that die on the farm would also have a substantial influence on the

spread of BSE if the disease were introduced.” The base case scenario showed that the mean

total number of ID50s (i.e., dosage sufficient to infect 50 percent of exposed cattle) from healthy

animals at slaughter presented to the food/feed system was 1500. The mean total number of

ID50s from adult cattle deadstock presented to the feed system was 37,000. This illustrates the

risk of “4D cattle” (i.e., deadstock).

From the Harvard Risk Assessment, 2001, Appendix 3A Base Case and Harvard Risk

Assessment, 2001 Executive Summary

McDonald’s also urges agencies of the US government to work with academia and industry on

research in the following areas:

• Methods to inactivate TSEs agents which then may allow a product to be used and even

fed to animals without risk

• Alternative uses for animal byproducts which would maintain some value

In July 2004, McDonald’s in cooperation with others sponsored a meeting at Penn State. The

purpose of the meeting was to review work conducted by Dr. Bruce Miller looking at the

feasibility of using carcasses and animal byproducts as renewable alternatives to fossil fuels in

large energy generating boilers. A number of government representatives were also invited to

this meeting. We are aware that Dr. Miller continues this work which shows great promise. We

suggest that the FDA explore the possibility of this alternative use that may also have a positive

impact on the environment.

The McDonald’s Corporation will continue to work with the FDA and other government

agencies to implement a strong BSE risk control program. We would like to reiterate our

opinion that for the FDA to provide a more comprehensive and protective feed ban, specified

risk materials (SRMs) and deadstock must be removed from all animal feed and that legal

exemptions which allow ruminant protein to be fed back to ruminants (with the exception of

milk) should be discontinued. Thank you for the opportunity to submit these comments to the

public record.

Respectfully,

Dick Crawford

Corporate Vice President, Government Relations

630-623-6754 Direct

630-623-3057 Facsimile

dick.crawford@mcd.com

C:\Documents and Settings\mc07605\My Documents\MYDATA\BSE - US\FDA\Final McD's comments to FDA Rule 12-19-05.doc


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273_emc-000134-02.pdf

THE SEVEN SCIENTIST REPORT ***


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf


Date: Sat, 14 Jan 2006 10:08:21 -0600
Reply-To: Bovine Spongiform Encephalopathy
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: Re: McDonald's Corp. seven scientists and experts and a
pharmaceutical supplier Seriologicals Corp. U.S. NOT PROTECTED
AGAINST MAD COW DISEASE


##################### Bovine Spongiform Encephalopathy #####################

pharmaceutical supplier Seriologicals Corp.
9 December 2005


snip...


9 December 2005
Division of Dockets Management (RFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)
Substances Prohibited From Use in Animal Food and Feed
Dear Sir or Madame:
Serologicals Corporation is a global provider of biological products to life
science companies.
The Company’s products are essential for the research, development and
manufacturing of
biologically based diagnostic, pharmaceutical and biological products.
customers include
many of the leading research institutions, diagnostic and pharmaceutical
companies throughout
the world. The Company’s products and technologies are used in a wide
variety of applications
within the areas of neurobiology, cell signaling, oncology, angiogenesis,
apoptosis,
developmental biology, cellular physiology, hematology, immunology,
cardiology, infectious
diseases and molecular biology.
A number of our products are derived from bovine blood or other bovine
tissues sourced in the
United States, hence the overall health of the national herd is extremely
important to our
company as well as to our customers and their patients. Some of our bovine
based products are
used in the manufacture of vaccines and drugs for humans, hence it is
critical that all measures
are taken to assure these are safe and free from disease especially Bovine
Spongiform
Encephalopathy (BSE). The most effective way to insure this is to create a
system which
processes cattle that are BSE free. ...

snip...

The current proposed rule falls short of this and would still leave a
potential source of infectivity
in the system. In fact by the FDA’s own statement the exempted tissues which
are known to
have infectivity (such as distal ileum, DRGs, etc) would cumulatively amount
to 10% of the
infectivity in an infected animal, This proposed rule would still allow for
the possibility that
cattle could be exposed to BSE through:
1. Feeding of materials currently subject to legal exemptions from the ban
(e.g., poultry
litter, plate waste)
2. Cross feeding (the feeding of non-ruminant rations to ruminants) on
farms; and
3. Cross contamination of ruminant and non-ruminant feed
We are most concerned that the FDA has chosen to include a provision which
would allow
tissues from deadstock into the feed chain. We do not support the provision
to allow the removal
of brain and spinal cord from down and deadstock over 30 months of age for
several reasons.
These are the animals with the highest level of infectivity in tissues which
include more than
brain and spinal cord. We do not feel that there can be adequate removal and
enforcement of this
regulation especially during warmer weather. In addition there is emerging
information that at
end stage disease, infectivity may also be included in additionai tissues
such as peripheral nerves
(Buschmann and Groschup, 2005).
Leaving the tissues from these cattle in the animal feed chain will
effectively nullify the intent of
this regulation. This point is illustrated by the 2001 Harvard risk
assessment model which
demonstrated that eliminating dead and downer, 4D cattle, from the feed
stream was a
disproportionately effective means of reducing the risk of re-infection “The
disposition of c&e
that die on the farm would also have a substantial influence on the spread
of BSE if the disease
were in traduced. ...

snip...

Respectfully,
SEROLOGICALS CORPORATION
James J. Kramer, Ph.D.
Vice President, Corporate Operations

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf

Date: Tue, 10 Jan 2006 09:39:57 -0600
Reply-To: Bovine Spongiform Encephalopathy
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: MAD COW FEED BAN WARNING LETTER December 21, 2005

##################### Bovine Spongiform Encephalopathy #####################

Subject: MAD COW FEED BAN WARNING LETTER December 21, 2005
Date: January 10, 2006 at 7:18 am PST
Public Health Service
Food and Drug Administration

Kansas City District
Southwest Region
11630 West 80th Street
Lenexa, Kansas 66214-3340


December 21, 2005

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

Ref. KAN 2006-08

Mr. Paul Rasmussen, President
Gold Eagle Cooperative Board of Directors
1145 Birch Ave
Corwith, IA 50430

Dear Mr. Rasmussen:

An investigator from our office conducted two inspections of your animal feed manufacturing operations at 415 N. Locust St., Goldfield, Iowa on August 23 and August 25 -26, 2005. During these inspections, a significant deviation from the requirements set forth in Title 21, Code of Federal Regulations (CFR), Part 589 .2000 [21 CFR 589 .2000] - Animal Proteins Prohibited in Ruminant Feed, was identified . The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Our investigation found a failure to label one of your products, "ISLACT - IS LACTATION," a swine feed, with the statement "Do Not Feed to Cattle or Other Ruminants," as required by 21 CFR 589 .2000(d) . Although your swine feed is not formulated with protein derived from mammalian tissues as defined in 21 CFR 589 .2000(a)(1), which is prohibited in ruminant feed, your production practices may cause the finished product to contain such material. Our investigator found that your firm does not have a strategy for sequencing feeds and does not flush or otherwise clean shared production equipment between the manufacture of poultry feed formulated with protein derived from mammalian tissues and swine feed formulated without such material . As a result, swine feed may acquire protein derived from mammalian tissue from poultry feed residue remaining on the shared production equipment. Your failure to label your "ISLACT - IS LACTATION" swine feed with the statement "Do Not Feed to Cattle or Other Ruminants" causes it to be misbranded under section 403(a)(1) of the Act.

The above is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of animal feed, you are responsible for ensuring that your overall operation and the products you manufacture and distribute comply with the law.

You should take prompt action to correct this violation and establish a system whereby such violations do not recur. Failure to promptly correct this violation may result in regulatory action, such as seizure and/or injunction, without further notice.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include an explanation of each step being taken to correct the violation and prevent its recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Please send your reply to the Food and Drug Administration, Attention: Ralph Gray, Compliance Officer, 11630 West 80th Street, Lenexa, KS 66214-3340.

Sincerely,
/s/

C.R. Pendleton for John W. Thorsky
District Director
Kansas City District


http://www.fda.gov/foi/warning_letters/g5668d.htm


TSS

#################### https://lists.aegee.org/bse-l.html ####################

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

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


Page 1 of 17

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

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

To: fsis.regulationscomments@fsis.usda.gov

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

for the Disposition of Non-Ambulatory Disabled Cattle

Greetings FSIS,

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

Requirements for the Disposition of Non-Ambulatory Disabled Cattle

THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle

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

SUB CLINICAL PRION INFECTION

MRC-43-00

Issued: Monday, 28 August 2000

NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCH

FINDINGS RELEVANT TO CJD AND BSE


Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518

9/13/2005

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

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

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


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


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


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

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


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

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

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

PDF]Freas, William TSS SUBMISSION

File Format: PDF/Adobe Acrobat -

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

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


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

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

genotype can lead to an alternate phenotype that is indistinguishable

from type 2 PrPSc, the commonest _sporadic_ CJD

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

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

snip...

Greetings list members,

i just cannot accept this;

> 23 kg of meat in a suitcase (suitcase bomb...TSS)

> The data do not provide a species of origin code for these

> products, therefore they may not contain any ruminant product. what kind of statement is this?

how stupid do they think we are? it could also very well mean that _all_ of it was ruminant based products !

snip...

Greetings FDA and public, if you go to the below site, and search all BSE known countries and check out their air traffic illegal meat they have confiscated, and check out the low number checked, compared to actual passenger traffic, would not take too much for some nut to bring in FMD/TSEs into the USA as a 'suitcase bomb'.

[[Under APHIS-PPQ's agricultural quarantine inspection monitoring, 284 air passengers from Israel were sampled for items of agricultural interest in fiscal year 2001. Seven of these passengers, or 2 percent, carried a total of 11 kg of meat items that could potentially harbor the pathogen that causes BSE. None of these passengers from whom meat items were confiscated reported plans to visit or work on a ranch or farm during their visit to the U.S.]]

if they were to have questioned the terrorist that bombed the Twin Towers with jets, if they were to have questioned them at flight school in the USA, i am sure that they would have said they did not intend to visit the Twin Towers as a flying bomb either. what am i thinking, they probably did ask this? stupid me.

[[In 1999 a small amount of non-species specific meat and offal was imported and a small amount of fetal bovine serum (FBS) was also imported. FBS is considered to have a relatively low risk of transmitting BSE.]]

more of the USA infamous 'non-species coding system', wonder how many of these species are capable of carrying a TSE?

snip...

Greetings again List Members, let me kick a madcow around here a bit. on the imports from Poland and the infamous USA 'non-species' coding system. the USDA/APHIS states;

> During the past four years (1998 - 2001), US imports from

> Poland included non-species specific animal products

> used in animal feeds and non-species specific sausage and offal

> products (Table 3). Given US restrictions on ruminant product

> imports, these US imports should not have contained ruminant

> material.

NOW, if you read Polands GBR risk assessment and opinion on BSE, especially _cross-contamination_, it states;

ANNEX 1 Poland - Summary of the GBR-Assessment, February 2001 EXTERNAL CHALLENGE STABILITY INTERACTION OF EXTERNAL CHALLENGE AND STABILITY The very high to extremely high external challenge met a very unstable system and could have led to contamination of domestic cattle in Poland from 1987 onwards. This internal challenge again met the still very unstable system and increased over time. The continuing very high external challenge supported this development. Not OK MBM-ban since 1997, but no feed controls. Reasonably OK Heat treatment equivalent to 133°C / 20min / 3 bar standards, but no evidence provided on compliance. Not OK. No SRM-ban, SRM are rendered and included in cattle feed. BSE surveillance: Not sufficient before 2001. Cross-contamination: Lines for ruminant and non-ruminant feed in feed-mills only separated in time and no analytical controls carried out. Likely present since 1987 and growing. see full text and ANNEX 1 at;

http://europa.eu.int/comm/food/fs/sc/ssc/out185_en.pdf

so in my humble opinion, the statement by the USDA/APHIS that ''these US imports _should_ not have contained ruminant materials, is a joke. a sad joke indeed. * POLAND BSE GBR RISK ASSESSMENT

http://europa.eu.int/comm/food/fs/sc/ssc/out185_en.pdf

snip...

full text;

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

2006 POLAND BSE

Subject: Poland Bse and animal nutrition & bse, scrapie testing Member States
Date: February 8, 2006 at 10:58 am PST

01/2006 Poland Bse and animal nutrition 7693-2005

http://europa.eu.int/comm/food/fvo/act_getPDF.cfm?PDF_ID=4951


Annexes

http://europa.eu.int/comm/food/fvo/act_getPDFannx.cfm?ANX_ID=4540

http://europa.eu.int/comm/food/fvo/act_getPDFannx.cfm?ANX_ID=4541

Subject: New case of mad cow disease in Poland
Date: December 28, 2005 at 10:20 am PST

AFX News Limited
New case of mad cow disease in Poland
12.28.2005, 02:36 AM

WARSAW (AFX) - A new case of bovine spongiform encephalopathy (BSE), or mad cow disease, has been detected in Poland, the country's veterinary service said.

The head of the national veterinary service, Krzysztof Jazdzewski, said that the infected animal was found on a farm in the northwest of the country and had been put down.

'The disease was detected on a farm with a total of 18 animals. Eight of them have been identified as exposed to risk (of contamination) and have been killed,' he said.

There have been more than 22 cases of mad cow disease in Poland since it began testing for BSE in 2001.

newsdesk@afxnews.com

afp/jsa


http://www.forbes.com/afxnewslimited/feeds/afx/2005/12/28/afx2416658.html


TSS 2001

Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date: Tue, 9 Jan 2001 16:49:00 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de

######### Bovine Spongiform Encephalopathy
#########

Greetings List Members,

I was lucky enough to sit in on this BSE conference
call today and even managed to ask a question.
that is when the trouble started.

I submitted a version of my notes to
Sandra Blakeslee of the New York Times,
whom seemed very upset, and rightly
so.

"They tell me it is a closed meeting and
they will release whatever information
they deem fit. Rather infuriating."

and i would have been doing just fine,
until i asked my question. i was surprised
my time to ask a question so quick.

(understand, these are taken from my notes for now.
the spelling of names and such could be off.)

[host Richard Barns]
and now a question from Terry S. Singeltary of
CJD Watch.

[TSS]
yes, thank you,
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?

[no answer, you could hear in the back ground,
mumbling and 'we can't. have him ask the question
again.]

[host Richard]
could you repeat the question?

[TSS]
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?

[not sure whom ask this]
what group are you with?

[TSS]
CJD Watch, my Mom died from hvCJD and we are
tracking CJD world-wide.

[not sure who is speaking]
could you please disconnect Mr. Singeltary

[TSS]
you are not going to answer my question?

[not sure whom speaking]
NO

from this point, i was still connected, got to listen
and tape the whole conference. at one point someone
came on, a woman, and ask again;

[unknown woman]
what group are you with?

[TSS]
CJD Watch and my Mom died from hvCJD
we are trying to tract down CJD and other
human TSE's world wide. i was invited to
sit in on this from someone inside the USDA/APHIS
and that is why i am here. do you intend on banning
me from this conference now?

at this point the conference was turned back up,
and i got to finish listening. They never answered
or even addressed my one question, or even addressed
the issue. BUT, i will try and give you a run-down
for now, of the conference.

IF i were another Country, I would take heed to my
notes, BUT PLEASE do not depend on them. ask for
transcript from;

RBARNS@ORA.FDA.GOV
301-827-6906

he would be glad to give you one ;-)

Rockville Maryland,
Richard Barns Host

BSE issues in the U.S.,
How they were labelling ruminant feed?
Revising issues.

The conference opened up with the explaining of
the U.K. BSE epidemic winding down with about 30
cases a week.

although new cases in other countries were now
appearing.

Look at Germany whom said NO BSE and now have BSE.

BSE increasing across Europe.

Because of Temporary Ban on certain rendered product,
heightened interest in U.S.

A recent statement in Washington Post, said the
New Administration (old GW) has a list of issues.
BSE is one of the issues.

BSE Risk is still low, minimal in U.S. with a greater
interest in MBM not to enter U.S.

HOWEVER, if BSE were to enter the U.S.
it would be economically disastrous
to the render, feed, cattle, industries,
and for human health.

(human health-they just threw that in cause i was listening. I will now
jot down some figures in
which they told you, 'no need to write them down'.
just hope i have them correct. hmmm, maybe i hope
i don't ???)

80% inspection of rendering

*Problem-Complete coverage of rendering HAS NOT
occurred.

sizeable number of 1st time FAILED INITIAL INSPECTION,
have not been reinspected (70% to 80%).

Compliance critical, Compliance poor in U.K.
and other European Firms.

Gloria Dunason
Major Assignment 1998 goal TOTAL compliance.
This _did not_ occur. Mixed level of compliance,
depending on firm.

Rendering FDA license and NON FDA license

system in place for home rendering & feed
76% in compliance
79% cross contamination
21% DID NOT have system
92% record keeping
less than 60% total compliance

279 inspectors
185 handling prohibited materials

Renderer at top of pyramid, significant
part of compliance.
84% compliance

failed to have caution statement render
72% compliance & cross contamination
caution statement on feed, 'DO NOT FEED TO CATTLE'

56 FIRMS NEVER INSPECTED

1240 FDA license feed mills
846 inspected

"close to 400 feed mills have not been inspected"

80% compliance for feed.

10% don't have system.

NON-FDA licensed mills
There is NO inventory on non licensed mills.
approximately 6000 to 8000 Firms ???
4,344 ever inspected.
"FDA does not have a lot of experience with"

40% do NOT have caution statement 'DO NOT FEED'.

74% Commingling compliance

"This industry needs a lot of work and only half
gotten to"

"700 Firms that were falitive, and need to be
re-inspected, in addition to the 8,000 Firms."

Quote to do BSE inspection in 19 states by end
of January or 30 days, and other states 60 days.
to change feed status??? Contract check and ask
questions and pass info.

At this time, we will take questions.

[I was about the third or fourth to ask question.
then all B.S.eee broke loose, and i lost my train
of thought for a few minutes. picked back up here]

someone asking about nutritional supplements and
sourcing, did not get name. something about inspectors
not knowing of BSE risk??? the conference person assuring that Steve
Follum? and the TSE advisory Committee were
handling that.

Some other Dr. Vet, whom were asking questions
that did not know what to do???

[Dennis Wilson]
California Food Agr.
Imports, are they looking at imports?

[Conference person]
they are looking at imports,
FDA issued imports Bulletin.

[Linda Singeltary ??? this was a another phone in
question, not related i don't think]
Why do we have non-licensed facilities?

(conference person)
other feed mills do not handle as potent drugs???

Dennis Blank, Ken Jackson
licensed 400
non FDA 4400 inspected of a total of 6000 to 8000,

(they really don't know how many non licensed Firms
in U.S. they guess 6000 to 8000??? TSS)

Linda Detwiler
asking everyone (me) not to use emergency BSE number,
unless last resort.
(i thought of calling them today, and reporting the
whole damn U.S. cattle herd ;-) 'not'

Warren-Maryland Dept. Agr.
Prudent to re-inspect after 3 years.
concerned of Firms that have changed
owners.

THE END

TSS

############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
############


FROM New York TIMES

Subject: Re: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA
Posting of cut version...
Date: Thu, 11 Jan 2001 22:02:47 -0700
From: "Sandy Blakeslee"
To: "Terry S. Singeltary Sr."
References: 1

Hi terry -- thanks for all your help. I know it made a difference with
the FDA getting out that release.


From the New York Times NYTimes.com, January 11, 2001

Many Makers of Feed Fail to Heed Rules on Mad Cow Disease
By SANDRA BLAKESLEE

Large numbers of companies involved in manufacturing animal feed are not
complying with regulations meant to prevent the
emergence and spread of mad cow disease in the United States, the Food
and Drug Administration said yesterday.

The widespread failure of companies to follow the regulations, adopted
in August 1997, does not mean that the American food supply is unsafe,
Dr. Stephen Sundlof, director of the Center for Veterinary Medicine at
the F.D.A., said in an interview.

But much more needs to be done to ensure that mad cow disease does not
arise in this country, Dr. Sundlof said.

The regulations state that feed manufacturers and companies that render
slaughtered animals into useful products generally may not feed mammals
to cud-chewing animals, or ruminants, which can carry mad cow disease.

All products that contain rendered cattle or sheep must have a label
that says, "Do not feed to ruminants," Dr. Sundlof said. Manufacturers
must also have a system to prevent ruminant products from being
commingled with other rendered material like that from chicken, fish or
pork. Finally, all companies must keep records of where their products
originated and where they were sold.

Under the regulations, F.D.A. district offices and state veterinary
offices were required to inspect all rendering plants and feed mills to
make sure companies complied. But results issued yesterday demonstrate
that more than three years later, different segments of the feed
industry show varying levels of compliance.

Among 180 large companies that render cattle and another ruminant,
sheep, nearly a quarter were not properly labeling their products and
did not have a system to prevent commingling, the F.D.A. said. And among
347 F.D.A.-licensed feed mills that handle ruminant materials - these
tend to be large operators that mix drugs into their products - 20
percent were not using labels with the required caution statement, and
25 percent did not have a system to prevent commingling.

Then there are some 6,000 to 8,000 feed mills so small they do not
require F.D.A. licenses. They are nonetheless subject
to the regulations, and of 1,593 small feed producers that handle
ruminant material and have been inspected, 40 percent
were not using approved labels and 25 percent had no system in place to
prevent commingling.

On the other hand, fewer than 10 percent of companies, big and small,
were failing to comply with the record-keeping
regulations.

The American Feed Industry Association in Arlington, Va., did not return
phone calls seeking comment.

http://www.nytimes.com/2001/01/11/science/11COW.html

Subject:
USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL
Jan. 9, 2001
Date:
Wed, 10 Jan 2001 14:04:21 -0500
From:
"Gomez, Thomas M."
Reply-To:
Bovine Spongiform Encephalopathy
To:
BSE-L@uni-karlsruhe.de


######### Bovine Spongiform Encephalopathy
#########

USDA/APHIS would like to provide clarification on the following point
from
Mr. Singeltary's 9 Jan posting regarding the 50 state conference call.

[Linda Detwiler asking everyone (me) not to use emergency BSE number,
unless
last resort. (i thought of calling them today, and reporting the whole
damn
U.S. cattle herd ;-) 'not']

Dr. Detwiler was responding to an announcement made during the call to
use
the FDA emergency number if anyone wanted to report a cow with signs
suspect
for BSE. Mr. Singeltary is correct that Dr. Detwiler asked participants
to
use the FDA emergency number as a last resort to report cattle suspect
for
BSE. What Mr. Singeltary failed to do was provide the List with Dr.
Detwiler's entire statement. Surveillance for BSE in the United States
is a
cooperative effort between states, producers, private veterinarians,
veterinary hospitals and the USDA. The system has been in place for
over 10
years. Each state has a system in place wherein cases are reported to
either the State Veterinarian, the federal Veterinarian in Charge or
through
the veterinary diagnostic laboratory system. The states also have
provisions with emergency numbers. Dr. Detwiler asked participants to
use
the systems currently in place to avoid the possibility of a BSE-suspect
report falling through the cracks. Use of the FDA emergency number has
not
been established as a means to report diseased cattle of any nature.

############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
############

Subject:
Re: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE
CALL Jan.9, 2001
Date:
Wed, 10 Jan 2001 13:44:49 -0800
From:
"Terry S. Singeltary Sr."
Reply-To:
Bovine Spongiform Encephalopathy
To:
BSE-L@uni-karlsruhe.de
References:
1


######### Bovine Spongiform Encephalopathy
#########

Hello Mr. Thomas,

> What Mr. Singeltary failed to do was provide
> the List with Dr. Detwiler's entire statement.

would you and the USDA/APHIS be so kind as to supply
this list with a full text version of the conference
call and or post on your web-site?
if so when, and thank you.
if not, why not?

> The system has been in place for over 10 years.

that seems to be a very long time for a system to be in
place, and only test 10,700 cattle from some 1.5 BILLION head (including
calf crop). Especially since French
are testing some 20,000 weekly and the E.U. as a whole,
are testing many many more than the U.S., with less
cattle, same risk of BSE/TSEs.

Why does the U.S. insist on not doing massive testing
with the tests which the E.U. are using?
Why is this, please explain?

Please tell me why my question was not answered?

> U.S. cattle, what kind of guarantee can you
> give for serum or tissue donor herds?

It was a very simple question, a very important
question, one that pertained to the topic of
BSE/feed, and asked in a very diplomatic way.
why was it not answered?

If all these years, we have been hearing that
pharmaceutical grade bovines were raised for
pharmaceuticals vaccines etc. But yet the
USA cannot comply with feed regulations of
the ruminant feed ban, PLUS cannot even
comply with the proper labelling of the feed,
cross contamination etc.
Then how in the world can you Guarantee the feed
fed to pharmaceutical grade bovine, were actually
non ruminant feed?

Before i was ask to be 'disconnected',
i did hear someone in the background
say 'we can't'-- have him ask the question again.

could you please be so kind, as to answer these
questions?

thank you,
Terry S. Singeltary Sr. Bacliff, Texas USA

P.S. if you will also notice, i did not post that
emergency phone number and do not intend on passing
it on to anyone. I was joking when i said i should
call and report the whole damn U.S. Herd. So please
pass that on to Dr. Detwiler, so she can rest easily.

BUT, they should be reported, some are infected with TSE.
The U.S. is just acting as stupid as Germany and other
Countries that insist they are free of BSE.

TSS

----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Thursday, January 11, 2001 2:06 PM
Subject: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA
Posting of cut version...SNIP...END




Follow Ups:



Post a Followup

Name:
E-mail: (optional)
Subject:

Comments:

Optional Link URL:
Link Title:
Optional Image URL: