Qualitative Analysis of BSE Risk Factors in the United States February 13, 2000 at 3:37 pm PST (BSE red book)

From: Terry S. Singeltary Sr. (216-119-130-117.ipset10.wt.net)
Subject: Qualitative Analysis of BSE Risk Factors in the United States (part 1)
Date: February 13, 2000 at 3:37 pm PST

Contents; Executive Summary................1 Introduction.....................2 Sheep Population and Practices...3 Cattle Inventories and Practices.8 Slaughter Industry..............13 Rendering Industry..............15 Feed Industry...................19 Qualitative Assessment..........23 List of Figures.................25

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Executive Summary

Since 1986, Bovine Spongiform Encephalopathy (BSE) has been diagnosed in over 21,000 cattle, 0.5 percent of the United Kingdom adult cattle population or 9-10 percent of the beef and dairy operations. Almost exclusive to the United Kingdom, new cases currently average 325-350 per week. BSE is an unconventional infectious virus. Current hypotheses suggest that an increase in the exposure of cattle to the sheep scrapie agent via ruminant derived proteins in feedstuffs have led to a detectable incidence of the disease. While BSE is not known to exist in the United States, it is of concern when considering that receipts to farmers from cattle, sheep and related products are roughly $60 billion dollars per year and feed expenses are over $20 billion per year. This report contrasts the United States and United Kingdom sheep and cattle demographics along with characteristics of the slaughter, feed, and rendering industries. This contrast is followed by an analysis of major similarities and differences in order to arrive at a qualitative assessment of the risk of BSE at the national level. Within the United Kingdom, a number of key related factors provide possible explanations for a change in contact of cattle to sheep-derived proteins. Sheep numbers increased by 12 million head over the last decade allowing a probable increase in the prevalence of scrapie infected flocks. Increased sheep numbers led to a larger amount of sheep raw material from both fallen and slaughter stock in animal products. In addition, the adoption of a newer continuous rendering technology process along with a drastic reduction in hydrocarbon solvents have led to changes in the manufacturing processes. Similarities exist in the two countries usage of continuous rendering technology and the lack of usage of solvents, however, large differences still remain with other risk factors which greatly reduce the potential risk at the national level. The United Kingdom has 4 times as many sheep and 3 times as many ewes on a land mass slightly smaller than the State of Oregon. The higher density of sheep to land along with substantial movement of sheep is conducive to facilitating the spread of scrapie across the sheep population. In the United States, 80 percent of the sheep are in the 17 western States. With predators such as coyotes and large rangeland operations, removal of fallen and diseased sheep stock to be rendered is less complete compared to the specialized United Kingdom "knacker" industry. The ratio of all sheep to all cattle is 32 times greater in the United Kingdom. Likewise, the ratio of all mature sheep to all milk cows is 10 times larger. Sheep in the United Kingdom account for 14 percent of raw rendering material versus 0.6 percent in the United States. This computes to 3.4 pounds per dairy cow in the United Kingdom versus 2.8 ounces per head in the United States. Almost all cases have been in dairy herds with 89 percent of cases in cows 4 years and older. In the United States, 53 percent of all dairy cows are less than 4 years of age. In the United Kingdom, 70 percent of all dairy cows are older than 4 years. The United States feeds 41 pounds per 100 pounds of milk produced versus 21 pounds in the United Kingdom. However, for each pound of mature sheep meat and bone meal produced, 17 tons of dairy concentrate are fed in the United States versus 0.4 tons in the United Kingdom. The United States grows an abundance of plant based proteins. The United Kingdom has traditionally imported some 500-600,000 tons of soybeans. Moreover, the portion of animal proteins used as a percent of all other major feed proteins is 6-7 percent greater in the United Kingdom. While this qualitative analysis suggests the potential risk of BSE at the national level is substantially less, no analysis is made of the variation in the levels of risk across geographic areas of production. Of consideration are factors such as the concentration of mature sheep slaughter and the proximity of rendered products from mature sheep offal to dairy populations. A more indepth quantitative analysis of these and other risk factors are contained in the APHIS:VS Ouantitative Risk Assessment of BSE in the United States.

Qualitative Analysis of BSE Risk Factors - 1

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Introduction

Bovine Spongiform Encephalopathy (BSE) is an unconventional infectious virus. Virtually all cases have been in the United Kingdom with new cases currently averaging 325-350 per week. The current hypotheses suggest that an increase in the exposure of cattle to the scrapie agent via ruminant derived proteins in feedstuffs have led to a detectable incidence of the disease. Key related factors provide possible explanations for a change in the contact of cattle to sheep-derived protein. Sheep numbers increased in the last decade suggesting a probable increase in the prevalence of scrapie infected flocks. Increased sheep numbers led to a larger amount of sheep raw material from both slaughter and fallen stock in rendered animal products. Concurrently, cattle numbers trended down decreasing their contribution to total rendered product. The adoption of a newer, continuous rendering process allowed for lower temperature and/or shorter periods of time to be used in the manufacturing process. In addition, the decline in the usage of hydrocarbon solvents and the associated heat treatment used in this process potentially resulted in increased survival of the infectious agent.

The qualitative analysis presented in this report compares and contrasts the United States and United Kingdom sheep and cattle demographics along with characteristics of the slaughter, feed, and rendering industries. Comparisons between the two countries are presented at the aggregate or national level. For each sector, background and demographic information is given followed by a section outlining key differences between the two countries as it relates to BSE. This is followed by a qualitative assessment which syntheses the major similarities and differences in order to arrive at a broad estimate of risk at the national level.

Qualitative Analysis of BSE Risk Factors - 2

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Sheep Population and Practices

For the past 10 years, the sheep populations in the two countries have moved inversely. From a peak of 49 million head in 1942, United States' sheep inventories have trended down (Figure 1). Contributing factors include a shrinking consumer base, a higher relative price compared to other meats, wide price variations from small changes in supply, and a dwindling supply of experienced labor. Based on location and production practices, United States sheep operations can be geographically divided into two categories. First, 80 percent of all sheep are located in the 17 western States (Figure 2). Mostly white-faced breeds, these operations can contain both sheep and cow-calf enterprises. Available range lands constitute a major feed stock. The density of sheep to usable land is low, computed at 1 animal per 10 acres. Second, of the remaining 20 percent of sheep, many are in the upper Midwest. Often small and part-time operations, many of the sheep are black-faced breeds. The upper Midwest contains some of the highest densities of sheep to usable land at 1 animal per 3 acres (Figure 3).

The United Kingdom sheep population is increasing from a 1978-80 average of 30.4 million head to a 1989 inventory level of 42.9 million head (Figure 4). While sheep meat consumption is one-half the level of 20 years ago, less imports and production incentives have acted to increase domestic production. Moreover, the imposition of milk quotas coupled with a price support system whereby one-third of revenues are from non-market sources have boosted the number of combined sheep and dairy operations. Substantial movement of sheep occurs with animals, including ewes, transported from the highlands of Northern England and Scotland to the lowlands further south. In addition there is significant buying, selling, and transportation of sheep to arbitrage price differentials across areas.

Farm Size and Concentration

Although each country has roughly 92,000 sheep operations, the United Kingdom contains 4 times as many sheep with the distribution of sheep across different herd sizes varying significantly (Figure 5). Herd size distribution is even more pronounced in the United States where 50 percent of the sheep operations are of the smallest size category, 1-24 head, which accounts for only 4.5 percent of all sheep. Conversely, only 2 percent of the United States sheep operations are of the largest size category, 1000 + head, which accounts for 51 percent of all sheep. This compares with 55 percent of the United Kingdom sheep operations having between 100 and 1000 head and accounting for 47 percent of all sheep.

Scrapie Disease

Both countries have taken different approaches to sheep scrapie disease. The United States has employed indemnity payments and encouraged reporting as control measures. Scrapie has been reported in 35 States with most of the reported cases in the black-faced breeds (Figures 6 and 7). The reporting of scrapie has been notably influenced by the real (inflation adjusted) value of the indemnity payment (Figure 8). The 1980-90 cumulative reported incidence of scrapie is 7.5 flocks per 1000 flocks, with substantial intrastate variation.

With scrapie endemic for at least two hundred years, the United Kingdom has no national movement to encourage the control or reporting of the disease. Even though prevalence estimates are suspect, the results suggest that scrapie is common within all breeds. Further, the total number of all cases is substantially greater in the United Kingdom versus the United States.

Qualitative Analysis of BSE Risk Factors - 3

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Sheep Population and Practices

Key Factors

During the 1980's, the two countries' sheep populations moved inversely. The United Kingdom now has 4 times as many sheep and lambs and more importantly about 3 times as many mature sheep or sheep greater than 1 year old (Figure 9). This increase in the number of sheep in the United Kingdom allowed for a probable increase ia the prevalence of scrapie flocks. The result was more infected sheep material from slaughter and dead stock available for usage in animal protein products.

Unlike the United States where 50 percent of the sheep are on 2 percent of the farms, the United Kingdom has 47 percent of the sheep on one-half of the farms. This supports a more active market to buy, sell, and move stock sheep across the United Kingdom. This also facilitates a potential spread of scrapie across the population.

U.S. Sheep Inventory 1974 - 1990-

Thousands of animals

Figure 1

20,000

15,000

10,000

5,000

1975 1980 1985 1990. [[[chart above, and map below not available to scan and paste...TSS]]]

Number of Sheep and Lambs by State - 1990 U.S. total = 11,365.4 (Thousands)

Figure 2 MAP [[[not available...but shows Texas having the largest number, with the map showing it being the only state completely blackened in. It is measured in 1,000's of head, with the completely blackened area being > 1,000...TSS]]]

Source: USDA/NASS USDA:APHIS:VS -- Source: USDA/NASS *Preliminary

Qualitative Analysis of BSE Risk Factors - 4

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Sheep Population and Practices

U.S. SHEEP - COUNTY POP. DIST. 1987 (ANIMALS / ACRE)

Figure 3 [[[MAPS AND CHARTS NOT AVAILABLE...TSS]]]

U.K. Sheep Inventory 1978 - 1989

Thousands of Animals

Figure 4 [[[NOT AVAILABLE...TSS]]]

Source: Agricultural Statistics, United Kingdom

Figure 5 U.K. & U.S. Comparison of Sheep Numbers and Farms by Herd Size - 1989

Herd Size % of Sheep % of Farms (# head) U.S. U.K. U.S. U.K.

1-24 4.5 .3 50.0 11.0 25-99 13.5 2.7 34.0 21.0 100-299 14.0 11.4 10.0 27.0 300-999 16.7 35.4 4.0 28.0 1000 + 51.3 50.2 2.0 13.0

USDA:APHIS:VS Source: U.S. Ag Census U.S. Ag Statistics MAFF, United Kingdom

Qualitative Analysis of BSE Risk Factors - 5 __________________________________________________________________

Sheep Population and Practices

Cumulative Incidence of Scrapie in Sheep 1980-1990

Figure 6 Infected Scrapie Flocks/10,000 Ewes

0 to 0.016 0.017 fo 0.23 0.24 to 2.63 2.64 to 20.45

[[[Map Not Available...TSS]]]

U.S. Breed Distribution of Sheep Scrapie Reported (1947-1990)

Figure 7 [[[Chart not available...TSS]]]

Suffolk---------84.% Hampshire--------6.% Cheviots---------2.% Crossbreds-------1.% Southdowns-------0.5% Montadales-------0.25% Finns------------0.1% Merino-----------0.1% Cottswold--------0.1% Corriedale-------0.1% Dorset-----------0.1% Rambouillet------0.1% Breed not listed-5.7%

USDA:APHIS:VS

Qualitative Analysis of BSE Risk Factors - 6 __________________________________________________________________

Sheep Population and Practices

Effect of Indemnity on U.S. SCRAPIE Reporting

Scrapie Flocks Reported Indemnity Payment

Figure 8 [[[Not Available...TSS]]]

Figure 9 Sheep & Lamb Inventories - 1989 (thousand head)

U.S. U.K. U.K./U.S. (January) (June)

All Sheep & Lambs 10,858 42,885 4.0 Sheep > 1 year 7,521 21,284 2.8

USDA:APHIS:VS Source: MAFF, United Kingdom U.S. Dept. of Agriculture

Qualitative Analysis of BSE Risk Factors - 7 __________________________________________________________________

Cattle Inventories and Practices

Similar to sheep, cattle production has varied significantly within the two countries. Although the number of cattle have declined by 2 million head per year since 1975, the United States still maintains more than 8 times as many cattle (Figures 10 and 11) as the United Kingdom (Figure 12). Concentrate feeding remains an important practice with 75 percent of all cattle slaughtered having spent time in a feedlot. At 12 million head, the United Kingdom beef numbers have declined by 1.5 million head in the last 10 years. Unlike the United States where per capita beef consumption has dropped almost 6 pounds since 1987, the United Kingdom household consumption has remained relatively unchanged and reports of drastic decline in beef demand have been exaggerated. The number of dairy cows in both countries have declined but for different reasons. At 10.1 million head versus 2.9 million head, the United States has 3.5 times more cows. In the United States, per cow and total milk production have more than offset the decline in cow numbers (Figures 13 and 14). Milk support policies, genetic advances and more intensive management have encouraged the culling of older cows and the feeding of concentrates in the United States (Figure 15). Compared to the United Kingdom, dairy cows in the United States are on average 1.3 years younger, produce 5,000 more pounds of milk and consume 1.8 additional tons of concentrate feeds (Figure 16). Cow numbers in the United States are disproportionate to the herd size distributions. The smallest herd size category, 1-29 head, contains 45 percent of the farms but only 7 percent of the cows. The highest category, 200 + head, contains only 2 percent of the farms but 24 percent of the cows (Figure 16). The decrease in the United Kingdom dairy cow numbers of about 400,000 over the last ten years has been notably influenced by the imposition of dairy milk production quotas. A slight gain in per cow milk production has not been sufficient to compensate for the decline in cow numbers causing total milk production to decline. Unlike the United States, dairy, beef, and/or sheep are often combined operations with little concentrate fed. Roughly two-thirds of eventual cattle slaughter originate from dairy stock and approximately 5-7 percent of cows in cow-calf herds are culled dairy cows. Milk quotas have boosted the number of sheep raised with dairy. For England and Wales, 72 percent of sheep operations contain 81 percent of all sheep and 50 percent of all cattle (Figure 17). Compared to the United States, herd size distribution is more proportional across herd size classes in the United Kingdom.

Key Factors

The distribution by breed and functional type (Figure 18) indicates that 98 percent of all reported BSE cases in the United Kingdom have been in dairy herds. The proportion of cases is similar to the breed distribution and suggests no predisposition by breed to disease. Compared to the United Kingdom, United States dairy production is more intensive, using less grass and more concentrate feeds. Concentrates fed per cow ranges from 1.9 tons to over 5 tons. The sourcing and relative quantities of protein components in concentrates varies considerably depending on geographic location and prices of substitutes. Of critical importance are the relative age distributions. Fifty-three percent of the United States dairy cows are less than 4 years of age, whereas, 70 percent of the United Kingdom's dairy cows are greater than 4 years and have accounted for 89 percent of the BSE reported cases. In 1989, the occurrence of BSE in cows 2-3 years of age was approximately 12 cases per 10,000 cows (Figure 19). For cows greater than 4 years, the range was from 59 cases per 10,000 cows for age 7 and older to 288 cases per 10,000 for cows of age 5.

Qualitative Analysis of BSE Risk Factors - 8 ___________________________________________________________________

Cattle Inventories and Practices

At 329 affected herds per 10,000 herds, herds Containing 200 or more head (Figure 16) are at greatest risk of BSE in the United Kingdom. This compares with 14 herds per 10,000 herds for herds of less than 50 head. The United Kingdom has 9 percent of all dairy cows in the largest herd size category versus 24 percent in the United States. The ratio of all sheep to all catfie is 32 times greater in the United Kingdom versus the United States. Because of the extended incubation period, sheep greater than 1 year of age are of primary concern for scrapie disease. In this case, the ratio of all sheep greater than 1 year to all beef and milk cows is 29 times greater in the United Kingdom. For mature sheep to milk cows, the ratio is 10 times greater in the United Kingdom (Figure 20).

Total U.S. Cattle Inventory 1974 - 1990

Figure 10 Million Head

1975-132,000,000 1980-111,000,000 1985-110,000,000 1990-99,000,000*

Source: USDA:NASS USDA:APHIS:VS *Partial Estimate

U.K. Beef & Dairy Cattle Inventory 1978-1989

Thousands of Animals

Figure 11 [[[Not Available...TSS]]]

Source: Agricultural Statistics United Kingdom USDA:APHIS:VS

Qualitative Analysis of BSE Risk Factors - 9 _________________________________________________________________

Cattle Inventories and Practices

Cattle & Calf Inventories (thousand head) Figure 12 U.S. U.K. (1990) (1989)

All Cattle and Calves 99,337 12,016 Beef Cows 33,705 1,495 Milk Cows 10,149 2,867

Heifers, Steers, Bulls, and Calves 55,484 7,654

USD:APHIS:VS Source: MAFF, United Kingdom U.S. Dept. of Agriculture

Figure 13 [[[Not Available...TSS]]]

Number of U.S. Milk Cows and Average per Cow Milk Production (1965-1989)

USDA:APHIS:VS Source: USDA:NASS

Figure 14 [[[Not Available...TSS]]]

Total U.S. Milk Production 1965 - 1989 Million Pounds USDA:APHIS:VS Source: USDA:NASS

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Cattle Inventories and Practices

Dairy Cow Inventories, Average Milk Production and Concentrate Fed

U,S. (1990) U,K. (1989)

Dairy Cows 10,149 2,867 (thousand head)

Figure 15 Average Milk Production (Ibs/yr) 14,244 9,448

Concentrate Fed (Ibs/yr) 5,800 2,180

USDA:APHIS:VS Source: Agricultural Statistics & MAFF, United Kingdom, U.S. Dept. of Agriculture

Comparison of Herds, Cows and U.K. BSE Cases by Herd Size - 1988

Figure 16 Herd Size U.S. U.K. U.K. BSE* (# of head) % herds % cows % herds % cows case herds/ 10,O00 herds 1-29 45 7 27 6 14 30-49 23 18 23 15 50-99 23 32 34 39 72 100-199 7 19 14 30 193 200+ 2 24 2 9 329

*As of April 1988

USDA:APHIS:VS Source: Ag. Statistics United Kingdom The Veterinary Record (12/17/88) U.S. Dept. of Agriculture Figure 17

Sheep and Cattle Operations U.S. U.K. (1988) (1989)

Number of Sheep Operations 92,489 91,296 Number of Cattle Operations 1,176,346 70,378 Number of Dairy Operations 202,068 47,935

Percent of Sheep Operations 58% 72%* with Cattle

Percent of all Sheep 59% 81%* within Combined Operations

Percent of all Cattle within Combined Operations 4.5% 50%*

*Data for England and Wales only.

Source: MAFF, United Kingdom U.S. Dept. of Agriculture

Qualitative Analysis of BSE Risk Factors - 11 _________________________________________________________________

Cattle Inventories and Practices

U.K. Distribution of BSE Confirmed & Suspect Cases* by Breed & Functional Type Figure 18

Breed Dairy Cows Beef Cows Friesian/Holstein 662 0 Ayrshire/3/4 Ayshire 11 0 Guernsey/3/4 Guernsey 18 0 Hereford x Friesian 0 12 Devon x Frieslan 0 1 Jersey x Friesian 1 0 Shorthorn 1 0 Shorthorn x Danish Rd 1 0 Jersey 2 0 Charolais 0 1

-As of April 1988

USDA:APHIS:VS Source: MAFF, United Kingdom

Age Distribution of Dairy Cows U.K. Occurrence of BSE - 1989 Figure 19

U.K. BSE Occurrence Age Distribution (%) % of cases #cases per~ Age U.S. U.K. 10,000 cows

2 year old cows 31 10 .4 5

3 year old cows 23 20 11 7

4 year old cows 17 18 38 276

5 year old cows 12 16 35 288

6 year old cows 8 12 13 131

7+ year old cow 9 24 3 59

Average Age (years) 3.8 5.1

USDA:APHIS:VS Source: MAFF, United Kingdom U.S. Dept. of Agriculture

Animal Populations Figure 20 U.S. U.K. U.K./U.S. (1989)

Ratio of ALL SHEEP to ALL CATTLE .11 3.6 32.7

Ratio of ALL SHEEP to Milk Cows 1.1 15.0 13.6

Ratio of ALL SHEEP > lyr to ALL Beef & Milk Cows .17 4.9 28.8

Ratio of ALL SHEEP > lyr to ALL Milk Cows .74 7.4 10.0

USDA:APHIS:VS Source: MAFF, United Kingdom U.S. Dept. of Agriculture

Qualitative Analysis of BSE Risk Factors - 12 _________________________________________________________________

Slaughter Industry

As expected, the United States slaughters and produces 10 times more cattle and meat as the United Kingdom (Figure 21). For sheep however, the United Kingdom slaughters 3.5 times as many animals and 5.5 times as many ewes. At 843 million pounds, total sheep slaughter is 2.5 times greater than in the United States (Figure 22). Moreover, the numbers do not reflect the 300 million tons of imports some of which are live animals from the Irish Republic for slaughter in the United Kingdom.

Key Factors

The structure of the United States slaughter industry is more specialized with a large portion of the total supply originating from plants customized for specific species. Of the 4,500 commercial slaughter plants in the United States, 97 percent of slaughter comes from 1,300 federally inspected plants. In the United Kingdom, there are approximately 700 slaughter plants with 200 plants accounting for 85 percent of the total slaughter. Although some plants are species specific, many plants accommodate sheep, cattle, and swine which reflects the fluid movement and sale of animals around the country. There are only some 50 plants which contain inspectors and are licensed for export.

In the United Kingdom, 60 percent of the sheep slaughter occurs in the last 2 quarters and 18 percent in the 2nd quarter. In the United States only slight variation occurs over the four quarters. Cattle slaughter across quarters is fairly constant for both countries.

Concentration at point of slaughter is more pronounced in the United States. In 1989, eleven plants, each of which slaughtered more than 100,000 head, accounted for over 80 percent of total lamb slaughter (Figure 23). Twenty-four plants, each of which slaughtered more than 3,000 head, accounted for over 80 percent of total slaughter of sheep greater than one year old.

U.S. & U.K. Sheep & Cattle Slaughter - 1989

Figure 21

U.S. U.K.

All Cattle Slaughtered (thousand head) 36,330 3,667 / Average Dressed Carcass Weight (lbs) 683 634 / Total Production (million lbs) 23,098 2,127

All Sheep Slaughtered (thousand head) 5,572 20,338 / Total production (million lbs) 348 843*

Ratio of Cattle to Sheep Slaughter (lb basis) 66 2.5

*Does not include live animals imported from Irish Republic for slaughter.

USDA:APHIS:VS Source: MAFF, United Kingdom U.S. Dept. of Agriculture

Qualitative Analysis of BSE Risk Factors - 13 __________________________________________________________________

Slaughter Industry

Number & Age of Sheep Slaughter 1989 Figure 22

U.S. U.K. All Sheep Slaughter (thousand head) 5,572 20,338 Lamb Slaughter 5,225 18,398 Mature Sheep 347 1,940 Slaughter Ratio of Lamb to Ewe 15 9.5 Average Dressed Weights (lbs) Lambs 58 40 Mature Sheep 64 47

Mature Sheep as a Proportion of Total Dressed Weight 6.8% 11.0%

USDA:APHIS:VS

1989 Geographic Distribution of Plants Accounting for 80 Percenf of Sheep & Lamb Slaughter

Figure 23 [[[Not Available...TSS]]] Interesting though, the state of Texas shows mature sheep slaughter > 3,000 head and lamb slaughter > 100,000 head and mature sheep slaughter > 3,000 head...TSS]]]

USDA:APHIS:VS

Qualitative Analysis of BSE Risk Factors - 14

From: Terry S. Singeltary Sr. (216-119-130-117.ipset10.wt.net) Subject: Qualitative Analysis of BSE Risk Factors in the United States (part 2) Date: February 13, 2000 at 3:41 pm PST

Rendering Industry

The rendering industries in both countries continue to undergo substantial structural adjustment. The current number of inedible renders in the United States is approximately 331, down from 990 in 1978. The decline of roughly 50 operations per year is attributable to several factors including changes in technology and slaughter industry practices. The older and more resource intensive batch rendering process is largely being replaced by a more efficient continuous processing technology. With the exception of some large poultry rendering operations, most of the rendering capacity uses the newer continuous rendering process. Prior to the mid 1970's, petroleum based solvents were used to further separate solids from oils, producing meat and bone meal with a 1-2 percent fat content. The increased price of oil corresponding with a market acceptance of a higher fat content has resulted in a virtual phaseout of solvents in the production process. Variation in product quality is more a function of management expertise than technology used. Because meat and bone meal is a small component of all protein sources, it is priced based on competing products such as soybean meal.

Two-thirds of the 45 rendering plants in the United Kingdom use the older batch process but account for only one-fourth of total output. The remaining 75 percent is produced at 15 plants. One firm operates 5 plants and accounts for 50 percent of the total output. Continuous processing technology was introduced in the 1970's and the usage of solvents declined to about 10 percent of total output by the early 1980's (Figure 24). The adoption of newer production technologies and the change in solvent usage appears to lag the United States by at least 5 years.

Key Factors

There are two important structural distinctions between the two countries (Figure 25). A "knacker" industry primarily handles the pick-up of dying and fallen stock from which a product called "greaves" is made. Greaves is either sold as pet food or purchased by renders to be combined with other animal raw materials for processing. The second important distinction is the movement of raw materials (before processing) and/or greaves among different renders. This is attributed in part to the geographic proximity of the plants, relative production efficiencies, and end product requirements. For example, the pet food industry sources specific types of organs and tissues from only certain species.

Figure 26 compares animal protein production for the two countries. The calculations are based on slaughter numbers, fallen stock estimates, and product yield coefficients. This approach is used due to variation of up to 80 percent from different reported sources. At 3.6 million tons, the United States produces 8 times more animal rendered product than the United Kingdom.

The risk of introducing the BSE agent through sheep meat and bone meal is more acute in both relative and absolute terms in the United Kingdom (Figures 27 and 28). Note that sheep meat and bone meal accounts for 14 percent, or 61 thousand tons, in the United Kingdom versus 0.6 percent or 22 thousand tons in the United States. For sheep greater than 1 year, this is less than one-tenth of one percent of the United States supply.

The potential risk of amplification of the BSE agent through cattle meat and bone meal is much greater in the United States where it accounts for 59 percent of total product or almost 5 times more than the total amount of rendered product in the United Kingdom.

Qualitative Analysis of BSE Risk Factors - 15 _________________________________________________________________

Rendering Industry

An estimate of the distribution of rendered product by species is shown in Figure 29. Prior to the United Kingdom's ban on feeding ruminant products to rnminants, 10-20 percent of rendered products went to cattle. The United Kingdom has been a net exporter of animal protein shipping up to 5 percent of total supply.

In the United Kingdom there is much concern for a specific continuous rendering technology which uses lower temperatures and accounts for 25 percent of total output. This technology was originally designed and imported from the United States. However, the specific application in the production process is _believed_ to be different in the two countries.

The application of solvent in the production process requires an additional reheating of product in order to burn off any remaining solvent residues. Whether it is the application of solvent or the reheating of product that may reduce any potential infectivity is uncertain. If all mature sheep meat and bone meal were fed to dairy cows it would amount to 3.4 pounds per cow per year in the United Kingdom and 2.8 ounces per cow in the United States.

Change in U.K. Rendering Processes 1964-1988

· MBM Produced Solvent Extraction · MBM from Continous Rendering

Figure 24 [[[Not Available...TSS]]]

USDA:APHIS:VS Source: MAFF, United Kingdom Figure 25

U.S. Rendering Industry Structure Slaughter--->Render<---Fallen Stock U.K. Rendering Industry Structure Slaughter--->Render<---Knacker(Greaves)<---Fallen Stock ^ Render USDA:APHIS:VS Qualitative Analysis of BSE Risk Factors - 16

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Rendering Industry Figure 26 Animal Protein Rendered Production - 1989 (less blood, feather, and fish meal) U.S. U.K. Total Rendered Product (thousand tons) 3,648 438 Portion from Cattle Slaughter (%) 59 43 Portion from Hog Slaughter (%) 20 25 Portion from Poultry Slaughter (%) 21 18 Portion from All Sheep Slaughter (%) 0.6 14 USDA:APHIS:VS U.S. Rendered Animal Protein* Estimated Species Composition - 1989 Figure 27 [[[Not Available...TSS]]] Sources: U.S. Dept. of Agriculture U.S. Dept. of Commerce USDA:APHIS:VS National Rendering Assoc. Qualitative Analysis of BSE Risk Factors - 17

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Rendering Industry U.K. Rendered Animal Protein* Estimated Species Composition - 1989 Figure 28 [[[Not Available...TSS]]] Distribution Estimate of Animal Rendered Proteins (percent) - 1989 Figure 29 U.S. U.K. Pet Food 34 10 Poultry 34 45 Hogs 17 40 All Cattle 13 0* Miscellaneous 2 5 *Prior to BSE restrictions of July 1988, the portion going to cattle was 10-20 percent. USDA:APHIS:VS Qualitative Analysts of BSE Risk Factors - 18

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Feed Industry Because of the relative abundance of protein sources, the usage of concentrates in the United States continues to increase over roughage and pasture (Figure 30). The bulk of concentrates fed are feed grains with very little food grains used (Figure 31). Almost all animal proteins fed to livestock and poultry start as a component of primary concentrate mixes (Figure 32). These feeds often form the basis for additional concentrate feeds. Meat and bone meal accounts for about 3 percent of primary concentrate tonnage (Figure 33) and 1.5 percent of the reported 183 million tons of concentrates fed in 1988 (Figure 34). The United Kingdom livestock production system is largely grass and roughage oriented. Figure 35 contrasts concentrate production with animal inventories. Of the almost 11 million tons of raw materials used in concentrates for 1988, over 5 million tons were from food grains such as wheat and barley. The United Kingdom imports 500-600,000 tons of soybeans per year. Key Factors Whereas 75 percent of cattle slaughter and 65 percent of sheep slaughter pass through feedlots in the United States, sheep and cattle in the United Kingdom receive much less concentrates. For dairy, the United States averages 41 pounds of concentrate fed per 100 pounds of milk produced. For the United Kingdom, the average is 21 pounds. Herd size and the number of farms is more skewed in the United States with average concentrates fed per cow varying as much as 3 tons across some States. Feed formulation in both countries are driven by least cost considerations subject to nutrient requirements. In terms of usage, Figure 36 shows that animal proteins as a percent of major protein substitutes have been 6-7 percent higher in the United Kingdom. It appears that palatability considerations have tempered additional usage of meat and bone meal in the United Kingdom. In the United States, the price for meat and bone meal tracks closely with soybean meal with the latter about $50-60 per ton less. In the United Kingdom, the price of meat and bone meal over the past 3 years has declined. The current price of $210 per ton is now less than the United States price of $220. An important difference in the two countries' feeding practices has been the inclusion (prior to the animal protein ruminant feed ban) of meat and bone meal in calf starter and other calf feeds in the United Kingdom. Calves were typically fed 55-65 pounds of calf starter potentially containing up to 4 percent meat and bone meal and/or blood meal. This amounted to roughly 2.3 pounds of meat and bone meal over a 12 week period. The feeding of meat and bone meal in calf starter in the United States is not _believed_ to occur. A worst case scenario denoting the highest potential risk would be to add all meat and bone meal produced from mature sheep offal to dairy concentrate feeds. The ratio of dairy concentrate fed to mature sheep meat and bone meal produced forms a measure of relative risk between the two countries. The higher the ratio the greater the dilution of total feed to sheep meat and bone meal produced and the less the risk. For the United States, the ratio is 34,760:1 or over 17 tons of dairy concentrate are fed to each 1 pound of sheep meat and bone meal produced. For the United Kingdom the ratio is 778:1, a difference of 45. Qualitative Analysis of BSE Risk Factors - 19

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Feed Industry Feed Consumed by U.S. Livestock & Poultry (1974 - 1987) (Corn Feed Value Equivalent) Concentrates ~ Harvested roughage ~ Pasture Million Tons Figure 30 [[[Not Available...TSS]]] Source: USDA:ERS *Preliminary USDA:APHIS:VS Feed Concentrates Fed to U.S. Livestock & Poultry (1974 - 1988) Feed Grains ~ Food Grains ~ Byproducts- Figure 31 Million Tons [[[Not Available...TSS]]] *Oilseed meals, animal protein feeds, milr byproducts, and mineral supplements USDA:APHIS:VS Source: USDA:ERS U.S. Feed Ingredient Mix In Primary Manufacturing- 1984 Total: 95,112,294 Tons Figure 32 [[[Not Available...TSS]]] Feed Grains 49% Animal Proteins 6% Microingredients 1% Other 6% Grain Byproducts 13% Minerals 5% Oilseed Meal 20% USDA:APHIS:VS Source: USDA:ERS Qualitative Analysis of BSE Risk Factors - 20

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Feed Industry U.S. Animal Protein Mix In Primary Manufacturing- 1984 Total: 5,413,098 Tons Figure 33 [[[Not Available...TSS]]] Meat/Bone Meal 55% Meal & Tankage 9% Feather Meal 5% Dry Milk Prod. 3% Poultry Byprod. 13% USDA:APHIS:VS Source: USDA:ERS Feed Concentrates Fed to U.S. Livestock & Poultry - 1988 Figure 34 [[[Not Available...TSS]]] USDA:APHIS:VS Source: USDA Qualitative Analysis of BSE Risk Factors - 21

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Feed Industry U.K. Production of Feed Concentrates and Animal Inventories - 1988 Figure 35 Concentrates Animal Inventories (thousand tons) (thousand head) All Cattle-All Feed 4,038.8 11,872 Dairy Cows-Dairy Feed 2,706.0 2,911 All Sheep-All feed 413.8 40,942 USDA=APHIS:VS Source: MAFF, United Kingdom Animal Proteins as a Oilseed Cake & Meal* Percent of Major Feed Components Figure 36 [[[Not Available...TSS]]] USDA:APHIS:VS Qualitative Analysis of BSE Risk Factors - 22

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Qualitative Assessment Considering the comparative factors presented, with the exception of some similarities in rendering practices, epidemiologic factors believed conducive to the introduction of BSE in the United Kingdom are significantly different in the United States. This is supported by the following points: Similar changes in the rendering practices have occurred in both countries. Continuous rendering accounts for the vast majority of all product produced. From 1977 to 1982, the portion of United Kingdom product rendered using hydrocarbon solvents dropped from 70 per-cent to 10 percent. Within the United States the decline was at least 5 years earlier with very little if any solvent in current use. With respect to sourcing of sheep offal, two important differences remain. First, the "knacker" industry in the United Kingdom benefits from a smaller geographic land base and higher density of all animals. In the United States, 80 percent of the sheep are located in the 17 western States, much of which is sparsely populated with limited agricultural alternatives. Across these large rangeland operations, coyotes provide some of the same fallen stock removal services as knackers. Second, the United States rendering industry does not move the amount of raw material between plants as is reported in the United Kingdom. Compared to the United States, the United Kingdom has 4 times as many sheep and 3 times as many mature sheep on a land mass slightly smaller than the State of Oregon. While scrapie continues in the United States, the number of sheep and farms has trended down. In the United Kingdom, little has been done to control scrapie which has been endemic for several hundred years. Several factors have allowed for an increase in the number of scrapie flocks in the last 10 years. This includes an increase of roughly 1.2 million head per year over the last decade, substantial movement of sheep from the highlands to lowlands and the fluid market for the purchase and sale of animals across the country. Note that in the United Kingdom, 55 percent of the sheep are on 47 percent of the farms. This compares with 51 per-cent of the sheep on 2 percent of the farms in the United States. In the United Kingdom, sheep make up 28 percent of ruminant meat production versus 1.5 percent in the United States. Mature sheep account for about 10 percent of sheep slaughter in the United Kingdom versus about 6 percent in the United States. Sheep in the United Kingdom account for about 14 percent of all rendered product versus 0.6 percent in the United States. If rendered mature sheep product went directly to dairy cows, it would amount to 3.4 pounds per head in the United Kingdom versus 2.8 ounces per head in the United States. Even though the United States cattle industry is over 8 times greater, the ratio of all sheep to all cattle is 32 times greater in the United Kingdom. Likewise the ratio of all sheep greater than 1 year to all milk cows is 10 times larger in the United Kingdom. The proximity of the two species in the United Kingdom has changed as incentives and milk quotas have led to an increased number of sheep coming in contact with dairy animals. A factor of consideration is the proportion of rendered sheep material available in proximity to the dairy population. Seventy-two percent of England and Wales' sheep operations contain 81 percent of the sheep and 50 percent of the beef and dairy. In the United States, 58 percent of the sheep operations contain 59 percent of the sheep but only 4.5 percent of the cattle. Qualitative Analysis of BSE Risk Factors - 23

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Qualitative Assessment About 98 percent of the BSE cases have been in dairy herds. Herd size distribution is more skewed in the United States with 24 percent of the cows on 2 percent of the herds of 200 plus head. This size class has the highest case rate computed as 329 affected herds per 10,000 herds and is consistent with higher concentrate usage associated with larger herd size. Per 100 pounds of milk produced the United States feeds 41 pounds of concentrate versus 21 pounds in the United Kingdom. How-ever, to measure potential risk from sheep meat and bone meal, the ratio of dairy concentrate fed to mature sheep meat and bone meal produced must be considered, where the larger the ratio the greater the dilution and the less the potential risk. For the United States, the ratio is 34,760:1 or over 17 tons of dairy concentrate fed to each pound of sheep meat and bone meal produced. For the United Kingdom the ratio is 778:1. Because of the purported long incubation period of the BSE agent, the average age of dairy cows becomes critical. In the United States, the average age is 3.8 years or 53 percent of all dairy cows are less than 4 years of age. In the United Kingdom, the average age is 5.1 years with 70 percent of dairy cows greater than 4 years. Note that 89 percent of the reported BSE cases are cows 4 years of age or older. The usage and composition of concentrates varies greatly across the two countries. The United States feeds far more concentrates and has an abundance of plant based proteins such as soybean meal and cotton-seed meal. The United Kingdom has traditionally exported up to 5 percent of meat and bone meal produced and imported 500-600,000 tons of soybeans. Moreover, the portion of animal proteins used as a percent of all other major feed proteins has been 6-7 percent less in the United States than United Kingdom. Also critical has been the in-clusion of meat and bone meal as a protein source in United Kingdom calf starter feeds. Comparable feeds in the United States are believed to contain plant based proteins. While this qualitative analysis suggests that the potential risk of BSE at the aggregate level is substantially less in the United States than the United Kingdom, recognition of potential variation in the levels of risk factors across geographic areas does not occur. Of further consideration are factors such as the concentration of mature sheep slaughter, rendered products produced, and the proximity of rendered products from mature sheep offal to dairy populations. Also, comparative usage of specific technologies in the rendering industry and verification of the usage of animal proteins in calf starter feeds. A more indepth quantitative analysis of these and other factors are contained in the APHIS-VS Ouantitative Risk Assessment of BSE in the United States... Qualitative Analysis of BSE Risk Factors - 25

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List of Figures U.S. Sheep Inventory 1974-1990 4 Number of Sheep and Lambs by State - 1990 4 U.S. Sheep - County Pop. Distribution - 1987 5 U.K. Sheep Inventory 1978-1989 5 U.K. & U.S. Comparison of Sheep Numbers and Farms by Herd Size - Cumulative Incidence of Scrapie in Sheep 1980-1990 6 U.S. Breed Distribution of Sheep Scrapie Reported (1947-1990) 6 Effect of Indemnity on U.S. Scrapie Reporting 7 Sheep & Lamb Inventories - 1989 7 Total U.S. Cattle Inventory 1974-1990 9 U.K. Beef & Dairy Cattle Inventory 1978-1989 9 Cattle & Calf Inventories 10 Number of U.S. Milk Cows and Average per Cow Milk Production 1965-1989) ......................................10 Total U.S. Milk Production 1965-1989........10 Dairy Cow Inventories, Average Milk Production and Concentrate Fed.11 Comparison of Herds, Cows and U.K. BSE Cases by Herd Size - 1988...11 Sheep and Cattle Operations...11 U.K. Distribution of BSE Confirmed & Suspect Cases by Breed & Functional type...12 Age Distribution of Dairy Cows U.K. Occurrence of BSE - 1989...12 Animal Populations...12 U.S. & U.K. Sheep & Cattle Slaughter - 1989...13 Number and Age of Sheep Slaughter - 1989...14 1989 Geographic Distribution of Plants Accounting for 80 Percent of Sheep & Lamb Slaughter...14 Figure 24 - Change in U.K. Rendering Processes 1964-1988...16 Figure 25 - U.S. & U.K. Rendering Industry Structure...16 Figure 26 - Animal Protein Rendered Production - 1989...17 Figure 27 - U.S. Rendered Animal Protein Estimated Species Composition - 1989...17 Figure 28 - U.K. Rendered Animal Protein Estimated Species Composition - 1989...18 Figure 29 - Distribution Estimate of Animal Rendered Proteins (percent) - 1989...18 Figure 30 - Feed Consumed by U.S. Livestock & Poultry (1974 - 1987)... 20 Figure 31 - Feed Concentrates Fed to U.S. Livestock & Poultry (1974-1988)...20 Figure 32 - U.S. Feed Ingredient Mix in Primary Manufacturing - 1984... 20 Figure 33 - U.S. Animal Protein Mix in Primary Manufacturing - 1984... 21 Figure 34 - Feed Concentrates Fed to U.S. Livestock & Poultry - 1988... 21 Figure 35 - U.K. Production of Feed Concentrates and Animal Inventories - 1988...22 Figure 36 - Animal Proteins as a Percent of Major Oilseed Cake & Meal Feed Components...22 Qualitative Analysis of BSE Risk Factors - 25 From: Terry S. Singeltary Sr. (216-119-130-117.ipset10.wt.net) Subject: Quantitative Risk Assessment of BSE in the United States Date: February 13, 2000 at 3:43 pm PST Contents Executive Summary.....1 Introduction.....2 Systems Model of BSE Epidemiology.....3 Scrapie/BSE Contamination of Rendered Product.....5 Infectious Rendered Product Incorporated into Cattle Feeds.....7 General Parameters and Assumptions of the Systems Model.....7 State-Level Quantitative Risk Assessment.....8 County-Level Quantitative Risk Assessment.....10 Conclusions.....14 List of Figures.....15

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Executive Summary

Bovine Spongiform Encephalopathy

(BSE) is a major new cattle disease problem. The current hypothesis suggests that BSE is the clinical manifestation of the sheep scrapie agent in cattle. While the disease has not been definitively diagnosed in the United States, sheep scrapie does exist along with the feeding of rendered sheep products to cattle. A qualitative analysis comparing risk factors of the United States and United Kinkdom provided little evidence to support a broad risk of BSE at the national level. However, the focus was on the aggregate level and did not address regional differences in the livestock production and related slaughter, rendering, and feed industry practices. This quantitative risk assessment was developed around a systems model of BSE. The model incorporated regional differences in sheep and cattle demographics, scrapie disease status, rendering, and feed industry practices. To identify levels of risk, a worst case scenario was defined by assuming that all meat and bone meal produced from mature sheep offal is mixed in dairy concentrate feeds. Relative risk was measured as the ratio of dairy concentrate fed to mature sheep meat and bone meal produced. The higher the ratio, the lower the potential risk. At the national level this ratio was 34,760 or over 17 tons of concentrate fed to dairy cattle for each 1 pound of sheep meat and bone meal produced. At the State-level the ratios varied from 1,252 to 54 million. At the county-level, the range was from 22 to over 10 million. The inclusion of meat and bone meal into least-cost feed formulation is dependent on price and palatability. Seven of the top 10 States with the lowest ratio of dairy concentrate fed to sheep meat and bone meal produced (highest risk) can produce more meat and bone than is actually used in feed. Such net surplus States may likely have lower prices and higher rates of inclusion when compared to States which must import. Overall, States with relatively few dairy cows but substantial mature sheep rendered, may be at higher risk than States with large dairy populations. To address regional differences, rendering trade areas were defined as the county and contiguous counties in which each rendering plant was located. The assumption was that mature sheep meat and bone meal rendered was fed to dairy in each defined area. This approach captured 50 percent of all United States dairy cows but biased upward the potential level of risk. Areas where the ratio of dairy concentrate fed to sheep meat and bone meal produced was less than 100 were considered at highest risk. Only 0.06 percent of all dairy cows were in counties with ratios below 100 and 0.8 percent were in counties with ratios below 1,000. On a regional basis, the largest number of cows in the high risk areas were located in the Upper Midwest. To incorporate scrapie in the risk assessment, six risk categories were identified based on the reported presence of scrapie by county and the number of dairy cows with Iow ratios of dairy concentrate fed to sheep meat and bone meal produced. Six States had at least one county with documented scrapie along with dairy cows located in a rendering area with a ratio less than 1,000. Despite wide geographic variation in concentrates fed and sheep meat and bone meal produced, little evidence existed to support a broad risk of BSE among a large portion of the dairy population. This was evidenced by the relative small amount of mature sheep meat and bone meal produced. In interpreting these results, consideration should be given to the simplifying assumptions surrounding the rendering trade areas and feed formulation. Also, this analysis assumes that infected sheep were the sole source of the BSE agent. 1 Qualitative Analysis of BSE Risk Factors in the United States, USDA:APHIS:VS, January, 1991.

Quantitative Risk Assessment of BSE - 1

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Introduction

Bovine Spongiform Encephalopathy (BSE) represents a major new cattle disease problem. The disease has been diagnosed in the United Kingdom, Ireland, Oman, and Switzerland. The current leading etiologic hypothesis suggests that BSE is a cattle variant of the sheep scrapie agent. Exposure of cattle to scrapie originated through the feeding of infectious rendered product from scrapie-infected sheep. Although the disease has not been definitively diagnosed in the United States, sheep scrapie exists as does the feeding of rendered sheep products to cattle. A comparison of the BSE risk factors between the United States and the United Kingdom facilitated a qualitative analysis of the risk of BSE within the United States 1. Similarities exist in rendering processes in the two countries, however, major differences are evident in the sheep and cattle demographics, relative slaughter of sheep and cattle, rendering industry, feeding practices, and composition of feed concentrates. The qualitative analysis of these risk factors suggests little evidence for a broad risk for BSE within the United States as a nation. Nevertheless, regional and temporal differences in the livestock, slaughter, rendering, and feed industries suggest that the risk is not homogeneous throughout the United States. This quantitative risk assessment develops a systems model of the epidemiology of BSE. Regional differences in the current United States sheep and cattle demographics, scrapie disease status, rendering practices, and feed industry are incorporated into the model in order to identify specific regions of the country in which BSE has the highest risk of occurrence. 1 Qualitative Analysis of BSE Risk Factors in the United States. USDA:APHIS:VS, January, 1991. Quantitative Risk Assessment of BSE - 2

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Systems Model of BSE Epidemiology

The leading hypothesis for the transmission of BSE can be diagrammed with a systems model (Figure 1). Cattle are exposed to the scrapie/BSE agent orally through contaminated animal protein feedstuffs. The feedstuffs become contaminated with infectious material by importation of contaminated protein concentrates from BSE affected countries or by incorporation of domestically- produced contaminated protein concentrates. Contamination of the rendered products occurs when scrapie-infected sheep or BSE-infected cattle or the offal from infected animals are processed by the rendering industry. The agent survives the rendering process to enter the animal protein concentrates. The systems model for the United States can be simplified after careful evaluation. Only a small amount of animal protein products enter the United States from known scrapie or BSE affected countries, therefore, this contribution appears to be negligible. Importation of live animals from BSE affected countries has been very limited. Further importation has been cancelled and traceback of animals imported over the past 10 years has not identified any clinically affected animals. Consequently, this potential contribution to the systems model appears to be negligible. The major contributors to the BSE systems model in the United States appear to be domestic scrapie-infected sheep (Figure 2). Infected sheep enter the animal feed chain through the rendering industry, either as offal generated through commercial slaughter or directly through the rendering of dead, dying, or diseased individuals. Rendered sheep products are incorporated into animal protein concentrates and enter cattle feeds as a protein source. Cattle ingest the infectious rendered product. Although the infectious dose is unknown and the oral route is not very efficient, this appears to be the route of infection. If cattle are being infected, then the agent may be recirculated through the rendering of cattle. Subclinically infected cattle generate offal at slaughter and clinically affected animals proceed directly to rendering. The critical control points in the systems analysis for the United States are: 1)the provision of scrapie infected sheep and BSE infected cattle to the rendering indnstry; 2)the survival of the agent through the rendering process; and 3)the incorporation of infectious material into animal protein products such as meat and bone meal. The infectivity of the final animal feed depends on both the concentration of the scrapie/BSE agent in the rendered product and the relative amount of infectious rendering animal protein in the feed. The survival of the scrapie/BSE agent in the rendering process is an accepted factor in the quantitative risk assessment. Therefore, regional and temporal influences at the other two critical control points, scrapie/BSE contamination of rendered product and infectious rendered product incorporation into cattle feeds, form the basis for the quantitative risk assessment. Quantitative Risk Assessment of BSE - 3

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Systems Model of BSE Epidemiology Figure I [[[Not Available...TSS]]] Systems Model of Hypothesized BSE Epidemiology and Surveillance NAHMS 7/25/90 Figure 2 [[[Not Available...TSS]] Systems Model of BSE Epidemiology (U.K. Hypothesis) Quantitative Risk Assessment of BSE - 4

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Scrapie/BSE Contamination of Rendered Product No clinical or subclinical BSE cases have been definitively diagnosed within the United States, so that the feedback or amplification route appears to be of minimal importance relative to the direct route of scrapie infected sheep entering the rendering process. The cumulative incidence of scrapie in sheep over the last decade provides an initial indication of the likelihood of infected sheep by region (Figure 3). The ratio of documented scrapie-infected flocks over the past 10 years compared to the current ewe population is significantly higher for the States east of the Mississippi River compared to the western States. Sixty-nine percent (69%) of the eastern States had a ratio greater than 0.24 infected scrapie flocks per 10,000 ewes compared to 27 percent of the western States. No scrapie infected sheep have been reported in 13 of the contiguous 48 States over the past 10 years. Scrapie is a disease of mature sheep ( > 1 year of age). Review of United States scrapie program records and the Veterinary Medical Database reveal less than 7 percent of the scrapie diagnoses in ewes less than 24 months of age (Figure 4). Therefore, offal from mature sheep slaughter and pickup of dead, diseased, and downer mature animals constitute the major source of scrapie contamination of rendered product.

Quantitative Risk Assessment of BSE - 5

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Scraple/BSE Contamination of Rendered Product

Cumulative Incidence of Scrapie in Sheep 1980-1990

Infected Scropie Flocks/10.000 Ewes

Figure 3 [[[Not Available...TSS]]]

Age Distribution of Sheep Diagnosed with Scrapie - U.S.

Figure 4

Age Number Percent (%)

< 17 Months 0 0 17 to 24 Months 48 6.9 25 to 36 Months 239 34.3 37 to 48 Months 254 36.4 49 to 60 Months 89 12.8 61 to 72 Months 43 6.2 72 Months 24 3.4 USDA:APHIS:VS Source: USDA:APHIS:VS Quantitative Risk Assessment of BSE - 6

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Infectious Rendered Product Incorporated into Cattle Feeds Rendered animal-derived protein products are incorporated into cattle feeds as a protein source. Concentrations of scrapie are highest in brain and lymphatic tissues and extremely low or absent in blood and muscle so that meat and bone meal appears to be the rendered product of highest risk for incorporation into cattle feeds. The rendering industry in the United States appears to be very localized, with hauling of raw materials within a 100-150 mile radius. As with other basic commodities, transportation of meat and bone meal is an important cost factor. The value of the meat and bone meal is tied to the price of feedgrain protein concentrates such as soybean meal. Incorporation of meat and bone meal into cattle concentrates depends on relative prices of other commodities as factored into least-cost ration formulations. Although most United States cattle receive concentrates, the most intensive concentrate feeding occurs with feedlot and dairy cattle. Feedlot cattle receive concentrates during the growth and finishing periods, while dairy cattle receive the highest levels of concentrate during peak milk production. Meat and bone meal does not _appear_ to be incorporated into calf starter rations. The incubation period of BSE is postulated to be 2.5 to 8 years. Consequently, feedlot cattle which are routinely slaughtered by 14-16 months of age are highly unlikely to demonstrate clinical signs of BSE even if infected. General Parameters and Assumptions of the Systems Model The systems model incorporated 7 major assumptions concerning scrapie contamination of the rendering process and the incorporation of infectious materials into cattle feed: 1) only the direct route of contamination of rendered product, i.e., scrapie infected sheep, was considered; 2) only mature sheep were considered as potentially scrapie infected; 3) all offal from mature sheep slaughter was considered to be processed at the nearest renderer; 4) dead, diseased, or downer mature sheep entered renderers in the same or contiguous counties only; 5) all mature sheep meat and bone meal was considered to be infectious; 6) only dairy cattle were considered to be at risk; and 7) all of the mature sheep meat and bone meal produced is fed to dairy cattle in the same county or contiguous counties in which the product was produced. These assumptions outline the worst case scenario given the current BSE hypothesis. The purpose of building the model with these assumptions is to identify areas of greatest risk for the occurrence of BSE within the United States. Quantitative Risk Assessment of BSE - 7

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State-Level Quantitative Risk Assessment The state-level quantitative risk assessment estimated the total dairy concentrate fed, the total mature sheep meat and bone meal produced, and computed the ratio of dairy concentrates fed to the mature sheep meat and bone meal produced. The computed ratios ranged from 1,252 to 54,554,117 for the 48 coterminous States (Figure 5). The areas with the lowest ratios represent the highest risk, for example, the lowest number of pounds of dairy concentrate fed per pound of mature sheep meat and bone meal produced. A second component of the state-level analysis addressed product availability and usage in formula feeds. The incorporation of meat and bone meal into least-cost feed formulation is dependent on price and palatability. The larger the ratio of meat and bone meal produced compared to the meat and bone meal usage in formula feeds, the more likely that the price will be lower and the product will be used up to the level of palatability. If little meat and bone meal is available compared to the usage in formula feed, then the price will be relatively higher and the usage will be less. Figure 6 provides a comparison of the net animal protein usage for selected States. Figure 7 provides both the ratio of dairy concentrate fed to mature sheep meat and bone meal produced and the ratio of animal protein produced to that used in formula feeds. The States with low ratios of dairy concentrate fed to sheep meat and bone meal produced combined with high ratios of animal protein produced to feed usage have the highest risk of BSE occurrence according to the systems model. Consequently some States with relatively few dairy cattle but a lot of mature sheep rendering, such as Colorado, appear to be at higher risk than some States with large dairy populations such as Iowa. Ratio of Dairy Concentrates Fed to Sheep Meat & Bone Meal Produced 1989 Figure 5 [[[Not Available...TSS]]] Quantitative Risk Assessment of BSE - 8


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State-Level Quantitative Risk Assessment Figure 6 [[[Not Available...TSS]]] USAD:APHIS:VS Animal Protein Produced and Formula Feed Usage Selected States - 1984 Figure 7 Dairy Concentrate Animal Protein Prod. State Fed/Sheep MBM /Feed Usage Michigan 14,639 1.2 Texas 14,439 4.0 Massachusetts 14,106 Kansas 13,032 3.1 Iowa 8,376 .7 Rhode Island 7,820 Colorado 4,620 4.4 Utah 4,058 2.6 New Mexico 1,561 1.1 New Jersey 1,252 3.3 USDA:APHIS:VS Quantitative Risk Assessment of BSE - 9

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County-Level Quantitative Risk Assessment The county-level analysis provided more detail than the State-level analysis and adjusted for regional differences within States. Renderers' locations were identified and a rendering trade and acquisition area was defined as the county where the renderer was located plus all of the contiguous counties. All mature sheep offal from slaughter and all dead, diseased, and downer mature sheep Were estimated for each rendering area. Total mature sheep meat and bone meal produced, and dairy concentrates consumed per cow were estimated within each rendering area. The model was used to compute the ratio of dairy concentrates fed compared to mature sheep meat and bone meal produced. The defined rendering areas contained approximately 50 percent of the total United States dairy cow population. Within individual rendering areas, the ratio of concentrate fed compared to mature sheep meat and bone meal produced varied from 22 to greater than 10 million (Figure 8). The highest risk category has the lowest ratios, eg, a ratio of 20 means only 20 pounds of dairy concentrate fed per pound of sheep meat and bone meal produced. Only 0.06 percent of the United States dairy cattle exist in counties with the highest risk (ratios below 100). Wide variations exist in the number of dairy cattle located in high risk areas of individual States (Figure 9). On a regional basis, the largest number of cows in high risk areas are located in the Upper Midwest (Figure 10). The next step in the risk assessment was to incorporate the cumulative reported incidence of scrapie over the last decade (1980-1990) into the systems model. The presence of documented scrapie flocks in a specific rendering area was considered to incriminate all mature sheep meat and bone meal as potentially contaminated. The ratios of reported scrapie flocks per 100 flocks and per 10,000 ewes varied widely across the States (Figure 11). Six risk categories were identified based on the reported presence of scrapie in specific rendering areas and the number of dairy cows in areas with low ratios of dairy concentrates fed to total mature sheep meat and bone meal produced (Figure 12). Six States (Iowa, Indiana, Kentucky, Michigan, New Jersey, and Texas) had at least one county with documented scrapie in a rendering area and dairy cows with ratios less than 999 pounds of dairy concentrate fed to mature sheep meat and bone meal produced (Figure 13). Ratio of Dairy Concentrate Fed to Sheep MBM (MBM · Meat & Bone Meal from Sheep Slaughter & Dead Sheep) Figure 8 Concentrate Fed/ Sheep MBM Produced # of cows % of cows I. 20-99 5,757 .06% II. 100-999 85,194 .8% III 1,000-9,999 621,079 6.2% IV. 10,000-99,999 1,950,981 19.3% V. 100,000-9,999,999 1,972,392 19.6% VI. > or = 10,000,000 371,162 3.7%

Cows Not Considered at Risk 5,078,132 50.4%

10,084,697 100.0%

USDA:APHIS:VS

Quantitative Risk Assessment of BSE - 10


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County-Level Quantitative Risk Assessment

# U.S. Cows Where the Ratio of Dairy Fed Concentrate to Sheep MBM is < 1,000 Selected States - 1988 Number of Cows (Thousands) Figure 9 [[[Not Available...TSS]]] # of U.S. Cows by Region Where the Ratio Fed Concentrate to Sheep MBM < 1,000 Selected States - 1988 Number of Cows (Thousand) Figure 10 [[[Not Available...TSS]]] USDA:APHIS:VS Qantitative Risk Assessment of BSE - 11

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County-Level Quantitative Risk Assessment Cumulative Reported Incidence of Scrapie, 1980-1990 AND Ratio of Dairy Concentrate Fed to Sheep MBM* Produced Selected States Figure 11 Incidence Per # Cows Where Ratio State Reported Flocks 100 Flocks 10,000 Ewes 20-99 100-999 MI 44 2.37 7.09 17,567 IN 43 1.55 7.66 746 NJ 7 1.26 9.22 18 1,793 VA 7 0.35 0.71 14 CO 5 0.28 0.16 2,867 K Y 2 0.23 0.83 1,515 TX 10 0.15 0.08 4,153 2,572 KS 3 0.14 0.23 478 19 IA 9 0.11 0.32 22.083 NE 2 0.08 0.16 939 WY 1 0.07 0.02 169 MN 1 0.03 0.07 19,378 USDA:APHIS:VS -Meat and Bone Meal from Sheep > = 1 year.

BSE Risk Categories

Figure 12

Scrapie Scrapie Ratio* Ratio* Reported Reported <> 10% no no > 10% - - - IV. no yes no yes V. no yes - - - - - - no no no < 10% VI. no no no no

*Ratio of Dairy Concentrate Fed to Sheep Meat&Bone Meal Prod. USDA:APHIS:VS

Quantitative Risk Assessment of BSE - 12

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County-Level Quantitative Risk Assessment

State Risk Categorie based on Scrapie Reported and the Ratio of Daily Concentrates Fed to Sheep MBM Produced**

[[[data not available, will not scan properly...TSS]]]

Quantitative Risk Assessment of BSE - 13

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Conclusions

The state and county-level quantitative risk assessments substantiate the conclusions of the qualitative comparison of risk factors between the United States and United Kingdom. Little evidence exists to support a broad risk for BSE among a large portion of the dairy population of the United States. This conclusion is supported by the fact that the proportion of animal proteins produced from mature sheep is extremely low. Substantial geographic variation exists in the ratio of dairy concentrates fed to the sheep meat and bone meal produced. Despite this variation, low ratios of dairy concentrates fed to sheep meat and bone meal produced affect very few cows.

These conclusions must be considered cautiously, since the analysis required a number of simplifying assumptions concerning the rendering industry and feed formulation and usage. Seasonal variation exists in the availability of sheep meat and bone meal as well as competing feed substitutes, therefore, feed formulations may vary considerably, compounding the problem of accurately estimated consumption of mature sheep meat and bone meal by dairy cattle. In addition, the entire risk assessment considers scrapie infected sheep as the only source of the BSE agent.

Quantitative Risk Assessment of BSE - 14


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List of Figures

Systems Model of Hypothesized BSE Epidemiology and Surveillance 4

Systems Model of BSE Epidemiology (U.K. Hypothesis) 4

Cumulative Incidence of Scrapie in Sheep 1980-1990 6

Age Distribution of Sheep Diagnosed with Scrapie - U.S 6

Ratio of Dairy Concentrates Fed to Sheep Meat & Bone Meal Produced - 1989 8

Animal Protein Produced & Formula Feed Usage I - Selected States - 1984 9

Animal Protein Produced & Formula Feed Usage II - Selected States - 1984 9

Ratio of Dairy Concentrate Fed to Sheep MBM 10

# U.S. Cows Where the Ratio of Dairy Fed Concentrate to Sheep MBM is < 1,000 - Selected States - 1988 11

# U.S. Cows by Region Where the Ratio Fed Concentrate to Sheep MBM is < 1,000 - Selected States - 1988 11

Cumulative Reported Incidence of Scrapie, 1980-1990 AND Ratio of Dairy Concentrate Fed to Sheep MBM Produced - Selected States 12

BSE Risk Categories 12

State Risk Categories Based on Scrapie Reported and the Ratio of Dairy Concentrates Fed to Sheep MBM Produced 13

Quantitative Risk Assessment of BSE - 15

___________________________________________________________


USDA:APHIS:VS AHI2.01/91

From: Terry S. Singeltary Sr. (216-119-138-126.ipset18.wt.net) Subject: U.S. Emergency Bovine Spongiform Encephalopathy Response Plan Summary Date: February 14, 2000 at 8:56 am PST

Subject: U.S. Emergency Bovine Spongiform Encephalopathy Response Plan Summary Date: Tue, 4 May 1999 18:25:12 -0500 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de

From: Terry S. Singeltary Sr., Bacliff, Texas......

I thought it might be interesting for those of you who have not seen this plan, to do so. So here it is...........

The mission of the U.S. Department of Agriculture (USDA) is to enhance the quality of life for the American people by supporting production agriculture; ensuring a safe, affordable, nutritious, and accessible food supply; caring for agricultural, forest, and range lands; supporting sound development of rural communities; providing economic opportunities for farm and rural residents; expanding global markets for agricultural and forest products and services; and working to reduce hunger in America and throughout the world.

USDA's Animal and Plant Health Inspection Service (APHIS) is responsible for ensuring the health and care of animals and plants. APHIS improves agricultural productivity and competitiveness and contributes to the national economy and the public health. USDA's Food Safety and Inspection Service (FSIS) is responsible for protecting the Nation's meat and poultry supply--making sure it is safe, wholesome, unadulterated, and properly labeled and packaged. These two agencies have come together to lead USDA's actions in the prevention, monitoring, and control of bovine spongiform encephalopathy (BSE) in the U.S. livestock and food supply. The public knows BSE as "MAD COW DISEASE", a disease linked to human cases of new-variant Creutzfeldt-Jakob disease (nvCJD). USDA knows BSE as the disease that devastated the livestock industry in the United Kingdom and shattered consumer confidence in Europe. BSE has affected international trade and all aspects of the animal and public health communities. It has called even greater attention to the U.S. Government's accountability for a safe food supply. No case of BSE has ever been found in the United States. Since 1989, USDA has had a number of stringent safeguards in place to prevent BSE from entering the country. USDA conducts an ongoing, comprehensive interagency surveillance program for BSE. This surveillance program allows USDA to monitor actively for BSE to ensure immediate detection in the event that BSE were to be introduced into the United States. Immediate detection allows for swift response. As an emergency preparedness measure, USDA has developed this BSE Response Plan to be initiated in the event that a case of BSE is diagnosed in the United States. The Plan details comprehensive instructions for USDA staff as to who is to do what, when, where, and how in the event that BSE were to be diagnosed in the United States.

BACKGROUND

APHIS is responsible for being prepared for potential FOREIGN animal disease outbreaks. The purpose of such preparation is to provide a step-by-step plan of action in the event that a FOREIGN animal disease, such as BSE, is detected in the United States. These plans, often referred to as "RED BOOKS", provide guidance by outlining certain actions that should take place, such as identification of a suspect animal, laboratory confirmation, epidemiologic investigation, and animal and herd disposition activities. Copies of Red Books for specific FOREIGN animal diseases are distributed to agency headquarters and each regional and field office to have in preparation for a disease outbreak.

In 1990, APHIS developed a plan to respond to a confirmation of BSE in the United States. In August 1996, a joint APHIS-FSIS working group updated the BSE Red Book in accordance with current science and research surrounding BSE and the related family of disease called transmissible spongiform encephalopathies (TSE's). The BSE Red Book is officially entitled BSE EMERGENCY DISEASE GUIDELINES. The APHIS-FSIS working group determined that the BSE Red Book, which detailed laboratory and field activities to be carried out in an emergency, needed another component. After the March 1996 announcement by the United Kingdom that BSE was linked to nvCJD, it became apparent to the working group that the Plan needed to address communication issues, both internally within USDA and the Federal Government and externally to the public at large. A confirmed case of BSE would affect such a vast array of stakeholders-consumers, cattle producers, the food animal industry, international trading partners, animal and public health communities, media, and others. Having clear, accurate information readily available would build trust and credibility and facilitate any response measures needed. There needed to be a notification plan. Who was responsible for notifying who, what, when, and how? The plan needed to identify clear channels of communication as to ensure immediate collection and dissemination of accurate information. The joint APHIS--FSIS working group became formally known as the BSE Response Team and is responsible for the development of this BSE Response Response Plan. BSE Response Team members represent a mix of backgrounds and expertise, including veterinary medicine, food safety, public health, epidemiology, pathology, international trade, and public affairs. The Team is coordinatied by two Team Leaders, one each from APHIS and FSIS, who serve as liaisons and technical advisors to their respective agencies on regulations and policies regarding BSE. Over the past 2 years, the BSE Response Plan has been reviewed, edited, revised, and approved by officials at all levels of APHIS, FSIS, and USDA. The Plan has also been shared with other Government agencies, such as the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH), and other stakeholders, such as the Animal Ag Coalition. The BSE Response Team monitors and assesses all ongoing events and research findings regarding TSE's. The Team leaders are responsible for ensuring that prevention and diagnostic measures are continually revised and adjusted as new information and knowledge become available.

NOTIFICATION: Roles and Responsibilities

Surveillance

As part of USDA's surveillance program for BSE in the United States, veterinary pathologists and field investigators from APHIS and FSIS have received training from British counterparts in diagnosing BSE. FSIS inspects cattle before they go to slaughter; these inspection procedures include identifying animals with central nervous system conditions. Animals with such conditions are considered suspect for BSE, prohibited from slaughter, and referred to APHIS for examination as explained below. Pathologists at APHIS National Veterinary Services Laboratories (NVSL) histopathologically examine the brains from these condemned animals. In addition, samples are tested using a technique called immunohistochemistry, which tests for the presence of the protease-resistant prion protein (a marker for BSE). NVSL also examines samples from neurologically ill cattle and nonambulatory ("DOWNER") cattle identified on the farm or at slaughter and from rabies-negative cattle submitted to veterinary diagnostic laboratories and teaching hospitals.

NOTIFICATION

Because of their responsibility for examining condemned or BSE-suspect animals, NVSL is the organization responsible for activating the notification and BSE response process. It is NVSL that will begin the activation of the BSE Response Plan. From the time a sample is submitted, it takes 14 to 18 days to confirm a diagnosis of BSE In the first 10 to 13 days, pathologists at NVSL have enough information to either rule out BSE or determine the need for additional tests. If it is determined that there is no evidence of BSE, the results are added to the more than 7,500 others that have also been negative. NVSL maintains these data. If additional tests do suggest a presumptive diagnosis of BSE, an NVSL pathologist will hand carry the sample to the United Kingdom for confirmation. It is at this critical point, when NVSL suggests a diagnosis of BSE and is preparing to send the sample to the United Kingdom, that this BSE Response Plan is initiated. The Plan begins the preliminary notification from NVSL to APHIS.

Prelimanary Notification

The director of NVSL is responsible for immediately notifying the APHIS, Veterinary Services (VS) deputy administrator when tests suggest a presumptive diagnosis of BSE. Once NVSL has made a presumptive diagnosis of BSE, APHIS and FSIS field activities will also be initiated. APHIS will receive notification (either confirming or not confirming NVSL's diagnosis) from the United Kingdom anywhere between 24 and 96 hours. (The international animal health community has recognized the United Kingdom's Central Veterinary Laboratory {CVL} as the world's reference laboratory for diagnosing BSE. Other countries, including Belgium, France, Ireland, Luxembourg, the Netherlands, Portugal, and Switzerland, have all sent samples to this lab to confirm their first case of BSE).

NVSL

NVSL will provide all laboratory support in carrying out this BSE Response Plan and serve as the liaison with CVL. NVSL will prepare its facility to receive and process additional samples from the suspect animal's progeny or herdmates or other suspects. NVSL will also coordinate any other assistance from State or university diagnostic laboratories if necessary.

APHIS, VS DEPUTY ADMINISTRATOR

Veterinary Services is the animal health arm of APHIS and the program responsible for carrying out field actions in response to BSE. Upon notifiction of a presumptive diagnosis from NVSL, the APHIS, VS deputy administrator immediately notifies the FSIS, Office of Public Health and Science (OPHS) deputy administrator. APHIS and FSIS deputy administrators will alert the BSE Response Team and activate the Response Plan. The VS deputy administrator serves as the liaison between the BSE Response Team and the APHIS administrator. The APHIS, VS deputy administrator notifies the APHIS administrator and the VS regional director of the State from which the suspect animal originated.

APHIS Administrator

The APHIS Administrator immediately notifies the USDA Assistant Secretary for Marketing and Regulatory Programs. This immediate notification will be followed by an official informational memorandum from the APHIS Administrator, through the Assistant Secretary for Marketing and Regulatory Programs, to the Secretary of Agriculture. This memorandum will be prepared by the BSE Response Team; a draft is maintained by the Team leaders in the reserved section of their plans. The APHIS Administrator is responsible for securing indemnity funds for depopulation of the herd if CVL confirms NVSL's diagnosis.

Assistant Secretary for Marketing and Regulatory Programs

The Assistant Secretary for Marketing and Regulatory Programs, in conjuction with the Undersecretary for Food Safety, is responsible for notifying the Secretary. The Assistant Secretary serves as the liaison between APHIS and Department-level officials.

Secretary of Agriculture

The Secretary has the authority to declare a Federal EMERGENCY if appropriate and approve funding as necessary. Information will be provided to the Secretary up the chain of command from the BSE Response Team.

FSIS, OPHS Deputy Administrator

The OPHS Deputy Administrator, together with the APHIS, VS Deputy Administrator, alert the BSE Response Team leaders and instruct them to assemble the BSE Response Team and activate the Plan. The OPHS Deputy Administrator serves as the liaison between the BSE Response Team and the FSIS Administrator. The OPHS Deputy Administrator is responsible for notifying the FSIS regional director in charge of the State from which the suspect animal originated.

FSIS Deputy Administrator

The FSIS Deputy Administrator is responsible for notifying the Undersecretary for Food Safety.

Undersecretary for Food Safety

The Undersecretary for Food Safety, in conjuction with the Assistant Secretary for Marketing and Regulatory Programs, notifies the Secretary of Agriculture.

APHIS, VS, Regional Director

The APHIS, VS regional director in charge of the State from which the suspect animal originated notifies the VS Area Veterinarian-in-Charge (AVIC) for that State. The regional director is the liaison between VS field staff and the VS Deputy Administrator at headquarters. In addition, the regional director shares all information with the BSE Response Team.

APHIS, VS, AVIC

The VS AVIC, in cooperation with State animal health authorities, is responsible for coordination the field activities surrounding the emergency response to BSE. The AVIC assembles the local VS staff to initiate activities outlined in the BSE Red Book including tracing the progeny and herdmates of the suspect animal and beginning an epidemiologic investigation. The VS AVIC coordinates with the State Veterinarian to quarantine the suspect animal's herd of origin. The State has the authority to order a routine quarantine for a neurological disease. The BSE Response Team surveyed every State to determine if they would utilize this authority in the event that NVSL identifies a presumptive diagnosis of BSE. All States responded that they would issue a quarantine.

BSE Response Team

The BSE Response Team leaders will notify each team member and instruct them to assemble in the Situation Room at APHIS headquarters in Riverdale, MD. The Team leaders are responsible for ensuring that all of the Team's duties are fulfilled. It is their responsibility to ensure that the technical information and expert recommendations reach the decisionmakers in a timely fashion. Together with VS Emergency Programs staff, the Team leaders will obtain APHIS, VS administrative support staff in Riverdale, MD, to ready the room for use as BSE headquarters. The Team will begin gathering and assembling information from APHIS and FSIS region and field staff. The Team will pull the draft documents from the third section in the Team leaders manuals and begin filling in current information as it becomes available.

Public Notification

Should NVSL receive notice from CVL confirming a case of BSE, the next level of notification is activated. Each player will follow the same notification protocol as described above for preliminary notification to confirm the diagnosis of a case of BSE.

BSE Response Team

The BSE Response Team will complete the informational memorandum for the Secretary. The Team will prepare the letter to the Office of International Epizootics (OIE), the international animal health organization, for signature by the APHIS, VS Deputy Administrator. OIE requires that all countries submit official notification within 24 hours of confirming a diagnosis of BSE. The BSE Response Team and the office of the APHIS, VS Deputy Administrator would coordinate a teleconference to inform all APHIS regional directors and AVIC'S. The BSE Response Team and the office of the FSIS, OPHS Deputy Administrator would coordinate a teleconference to inform all regional and field FSIS offices. The BSE Response Team would coordinate a teleconference to notify other Federal agencies. The BSE Response Team would coordinate a teleconference to notify key industry/consumer representatives. The BSE Response Team and APHIS International Services would notify foreign embassies. The BSE Response Team would establish a toll-free 800 telephone line for industry representatives, reporters, and the public. The BSE Response Team would coordinate with APHIS Legislative and Public Affairs and USDA office of Communications to issue a press release the day the diagnosis is confirmed. The press release would announce a press conference to be held the morning after the diagnosis is confirmed......

THE END

From: Terry S. Singeltary Sr. (216-119-138-126.ipset18.wt.net) Subject: Hunkering down in the APHIS BSE Situation Room... Date: February 14, 2000 at 9:04 am PST

Subject: hunkering down in the APHIS BSE Situation Room Date: Wed, 12 May 1999 01:55:54 -0800 From: tom Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de

i am looking now a bizarre Oct 98 internal USDA publication describing a james bond-type US effort to control media should the long-anticipated first case of BSE in the US be admitted.

'Players' on the 27 member BSE Response Team are to be flown in from all over the country to a BSE Headquarters 'situation room' apparently an underground bunker in Riverdale, Maryland under the command of the Assistant Secretary of Marketing.

Authentic press releases are already prepared and ready to go out after a few specifics have been filled in. They are spelled out in a separate document, the BSE Red Book, aka BSE Emergency Disease Guidelines.

Aphis' National Veterinary Services Laboratories (NVSL) activates team assembly. From the time a bovine brain sample is submitted, it takes 14-18 days to confirm a diagnosis of BSE. In the first 10-13 days, NVSL have enough information to determine the need for additional tests. If a provisional BSE diagnosis is made, the sample is 'hand-carried' (are they going to tell the airline and customs?) to the Central Veterinary Laboratory in England for confirmation, where they are expecting a 24 to 96 hour turn-around.

I guess that means we can get the white tiger brain analyzed by Friday despite the 22 year delay to date. Maybe we could throw in a few cougar brains from NE Colorado too.

A Team Member is designated to silently monitor this listserve and www.mad-cow.org (among others) -- for what, it doesn't say. The Freedom of Information Act request from the East Coast consumer group turned up numerous top-secret USDA downloads from that site and Dealler's.

After 24 hours of secret briefings for 'select industry and trading partners' (to allow them to take positions on the commodities markets opposite the 'non-select' industry and trading partners?), a press conference will be held the next day.

There are plans to trace the cow, its lineage, its herdmates, the renderer, traceout of product, buyout of herd, farm of origin, to get the state involved to quarantine the herd (pre-arranged for all 50 states), expectations for trade bans, notification of OIE within 24 hours, media 800 numbers, spokespersons and backups, notify CDC, FDA, NIH, and many other commendable activities. The Flow Chart is a sight to behold, I will try to scan it in tomorrow.

In short, that cow is going to be toast by the time the public first hears about it.

The Plan does not speak to the scenario in which the CVL says, yes, this is bovine spongiform encephalopathy all right but it is one of your strains, not ours. Invoking their Absence of Evidence is Evidence of Absence principle, there may be no perceived need for public disclosure in this case.

USDA is caught completely unprepared if BSE first turns up in a US zoo animal. These animals could easily be diagnosed outside the "system" and be the subject of a publicity-seeking lab press release. I think this is a more likely scenario because the US has likely imported many thousands of zoo animals with advanced infections from Britain and France and there has been zero monitoring. Unlike with downer cows, anyone with the right colleagues can get ahold of a fallen zoo animal. Zoo animals enter the food chain in some cases after being rendered.

Another scenario would be some stock market speculator obtaining the Red Book and issuing a flurry of bogus but authentic-looking press releases that included bogus 800 and hacked USDA web links. The press here is so lazy and so accustomed to putting out public relation handouts as news that the objectives would be accomplished for a few hour (or days, depending on the Response Team's paralysis vis-a-vis off-flow chart events). Some people think a practise run for this happened in the Indiana case a year or two back.

The first case of nvCJD in an American will also be a public relations fiasco. In the dim bulb of the public mind, any American with mad cow disease would have gotten it from eating meat here. USDA has no way to prove that the victim acquired it on a three week trip to England in 1987. This will sound lame even to the press. All CJD is synonymous with mad cow disease in the public perception; the more often the different kinds are explained, the more their suspicions are aroused. The first case of nvCJD in an American will simply validate what they already know and just be viewed as an overdue admission from the government.

tom

___________________________________________________________

From: Terry S. Singeltary Sr. (216-119-130-102.ipset10.wt.net) Subject: When a case of B.S.E. is found in the U.S/Response to Disease outbreak...'redbook' Date: March 13, 2000 at 10:13 am PST

BSE Red Book 2.1-26

5.0 Response to Disease Outbreak

5.1 Notifications

When the Deputy Administrator of VS and the Administrator of APHIS concur with the diagnosis of a presumptive case of BSE, the Response and Notification/ Briefing section of the BSE Response Plan will be activated. Because BSE is not known to be contagious or vector borne, a declaration of national emergency is not automatically necessary but may be requested if warranted by the particular circumstances of the outbreak.

5.1.1 Checklist of Notification Actions Upon Diagnosis of BSE See Response and Notification/Briefing sections of BSE Response Plan.

5.2 Declaring an Emergency

Because BSE has an extremely long incubation period, is not a herd disease, appears to be transmitted primarily by contaminated ruminant-origin rendered feed ingredients, and is not known to be contagious or vector borne, an outbreak of the disease is not an epidemiologic emergency. The declaration of an animal disease emergency need not be automatic. To avoid undue public alarm, an emergency should not be declared unless indicated by the particular circumstances of the BSE outbreak. The Secretary of Agriculture has authority under the Federal Act of July 2, 1962 (Title 21 U.S. Code, 134-134 h) to declare an emergency when a disease exists that constitutes a threat to the livestock or poultry industries of the United States. Title 9, Code of Federal Regulations (CFR), Part 76 contains regulations issued under this and other authorities. Declaration of an animal disease emergency authorizes the Federal Government to control and eradicate the disease problem and allows the Government to seek funds from the Commodity Credit Corporation (CCC) and other sources, to expend funds, and to place Federal quarantines on the interstam movement of animals and animal products. When appropriate, the Secretary would issue a formal declaration of emergency. All affected States would be notified and expected to cooperate by signing a Memorandum of Understanding (MOU) with the USDA specifying actions and responsibilities for activities such as surveillance, quarantine, indemnity, and seizure of animals. Both Federal and State quarantines may be used simultaneously. The most probable reason for declaring a BSE animal disease emergency would be the inability to obtain funds for BSE-related activities in any other manner, such as from the Secretary's contingency fund. Because BSE outbreaks do not spread rapidly, adequate time to seek funding from the usual sources or to prepare a budget request to Congress should be available.

October 1998

BSE Red Book 2.1-27

5.3 Declaring an Extraordinary Emergency

Under authority of the Act of July 2, 1962 (21 U.S. Code 134a, 134b, 134d, and 145f) the Secretary of Agriculture may declare an extraordinary emergency when adequate measures to control a disease are not being taken by thc State involved. These acts authorize the Federal Government to quarantine portions of a State, to enter premises after obtaining a warrant, and to seize and destroy animals if necessary to control the disease. It would seldom be necessary to declare an extraordinary emergency for an outbreak of BSE, except to obtain funding.

5.4 Authority To Pay Indemnity

Under provisions of Title 9, CFR, Part 53, USDA has the authority to pay the fair market value or up to 100 percent of the expenses to purchase and dispose of animals and materials required to be destroyed due to an FAD (BSE), depending on the availability of funds for that purpose. Because BSE can be transmitted through rendered animal products, CNS-suspect animals must not be sent to slaughter. In the event of a confirmed diagnosis of BSE or a presumptive diagnosis, notify FDA, CVM if carcasses have moved to rendering or animal feed manufacturing. Funds at 100 percent of the slaughter value at the time the suspect animal is surrendered to the Government may be paid for suspect animals, providing that:

*The animals are surrendered voluntarily to USDA for euthanasia and disposal, or for research, observation, and diagnostic purposes;

*The owner agrees to cooperate with all BSE epidemiologic investigations, diagnostic procedures, and disease preventive measures considered necessary by APHIS; and

*The Secretary of Agriculture or anthorized representative agrees to accept the animals.

At the beginning of a BSE outbreak, it is strongly recommended that APHIS choose to purchase all animals in an infected herd for research, observation, or depopulation.

5.5 Inspections and Seizures

Authority is provided under Section 5 of the Act of July 2, 1962 for Federal and State inspectors (when specifically designated by the Deputy Administrator of VS) to stop vehicles carrying bovids, make inspections, and seize animals and other items to prevent the transmission and spread of an FAD (BSE). The applicable authority, 21 U.S. Code 134d, states that:

"Employees of the Department of Agriculture designated by the Secretary for the purpose, when properly identified, shall have authority:

October 1998

BSE Red Book 2.1-28

"To stop and inspect, without a warrant, any person or means of conveyance, moving into the United States from a foreign country, to determine whether such person or means of conveyance is carrying any animal, carcass, product, or article regulated or subject to disposal under any law or regulation administered by the Secretary for prevention of the introduction or dissemination of any communicable animal disease; "To stop and inspect, without a warrant, any means of conveyance moving interstate upon probable cause to believe that such means of conveyance is carrying any animal, carcass, product, or article regulated or subject to disposal under any law or regulation administered by the Secretary for the prevention of the introduction or dissemination of any communicable animal disease; and "To enter upon, with a warrant, any premises for the purpose of making inspections and seizures necessary under such laws and regulations. Any Federal judge, or any judge of a court of record in the United States, or any United States commissioner, may within his jurisdiction, upon proper oath or affirmation indicating probable cause to believe there is on certain premises any animal, carcass, product, or article regulated or subject to disposal under any law or regulation administered by the Secretary for the prevention of the introduction or dissemination of any communicable animal disease, issue warrants for the entry upon such premises and for inspections and seizures necessary under such laws and regulations. Such warrants may be executed by any authorized employee of the Department of Agriculture."

Since BSE is infectious but not a contagious disease under normal circumstances, it will rarely be necessary to stop vehicles or seize animals and other related materials.

5.6 Other Authorities

Authorities for the control and eradication of diseases and pests of livestock and poultry are changed from time to time. Consult the Office of the General Counsel, USDA, and the Federal Register for authorities, rules, and regulations.

October 1998

BSE Red Book 2.1-29

6.0 Quarantine

6.1 Authority To Quarantine

State and Federal regulatory officials have authority to impose quarantines or hold orders. Usually, State quarantines are imposed on individual herds and premises when any foreign animal disease is suspected. Control of intrastate movement is by application of State authority. It is important to coordinate efforts with State officials. A survey of all State Veterinarians in the United States was conducted, and all agreed to use quarantine authority on a herd in their State in the event that BSE was diagnosed. In contrast, Federal quarantines control the interstate and international movement of diseased livestock. Only a declaration by the Secretary of Agricultare of an Extraordinary Emergency will provide Federal authority to control livestock movements within a State. Federal and State quarantines may be used simultaneously.

6.2 Suspected Premises Quarantine or Hold Order

When BSE or any foreign animal disease is suspected, the investigating veterinarian or FAD diagnostician should decide the issuance of a State quarantine or a hold order on the promises. The slow onset and progression of clinical signs will often require that an individual suspect animal be held and monitored for several weeks. Although BSE is not a rapidly spreading disease, the suspect animal or any other potentially infected carcasses must be kept out of the animal and human food chains and rendering channels. The reason for the issuance of the quarantine should be listed as a CNS suspect.

6.3 Affected Premises Quarantine

When there is presumptive diagnosis of BSE, movement of all bovine animals on and off the promises should be restricted to allow time for a thorough epidemiologic investigation. A hold order or quarantine indicating the number, age, sex, breed, and identification of all bovine embryos, ova. and semen supplies should be completed. No bovine animals, embryos, ova or semen from the affected premises shoald be sold, slaughtered, or rendered. Although the role of maternal transmission in the spread of BSE has not been fully determined and epidemiologic evidence suggests that maternal transmission may not be significant, cow-to-calf transmission cannot be ruled out. Hence, until more conclusive scientific evidence either confirms or refutes maternal transmission, precautions (an extended quarantine or other movement restrictions) to prevent disease spread via this route are prudent. At this time, natural progeny of the BSE-affected cows need to be traced and should be purchased. This recommendation may be modified if scientific research data become more definitive.

October 1998 2.1-30

BSE Red Book

It is strongly recommended that the Government (APHIS) purchase all cattle in the herd. No cattle from this herd shall be rendered. Tissues from cattle dying of neurologic or prolonged wasting condition should be submitted to a diagnostic laboratory. If the herd of birth and the herd of last residence of the infected animal are different, an investigation should be done to determine if husbandry practices in the herd of birth are the likely source of infection. Under certain circumstances, a quarantine (or other movement restrictions) of this herd may be warranted until the epidemiologic investigation is completed.

6.3.1 Affected Premises Security Record the number and permanent identification of bovine animals, embryos, ova and semen at the time of the quarantine or hold order. Animals should not be allowed to move unless permitted by a State or Federal animal health official. Introduction of new bovine animals to the premises should be discouraged. Because BSE is not a highly contagious disease, the need to post police or other monitoring personnel is not obligatory. Restriction of movements of non-Bovidae animals and vehicles or inanimate objects must be determined on a case-to-case basis. However, normal biosecurity and sanitary precautions should be observed.

6.3.2 Procedures on Affected Premises A detailed epidemiologic investigation (sec. 4) should be performed on all premises where BSE-confirmed animals are found. Evidence from the United Kingdom has shown that the clinical manifestation of BSE in any given herd is usually confined to a single animal or a small group of animals. Although another suspect is unlikely to be found, all cattle should be examined. If another suspect is identified, that animal should have tissues collected and submitted for diagnostic purposes after clinical signs have sufficiently progressed. Carcasses of BSE-confirmed or suspect animals should be incinerated. Because BSE is not known to be highly contagious or vector borne, herds found to contain a confirmed BSE case may or may not be depopulated. Depending on circumstances, the government may purchase all animals (suspect and exposed animals) for destruction or research purposes. Embryos, ova, and semen from herds with confirmed BSE animals should be held until an epidemiologic investigation is completed and the hold order or quarantine is removed. Milk from healthy animals in herds that have had BSE-confirmed animals may be used for consumption, but milk from BSE suspects should be withheld and disposed of in an environmentally acceptable method. Public health authorities should be informed of the herd's BSE status. Litter, bedding, feces, and urine from herds that have had BSE-confirmed animals is not likely to be infectious. However, materials should be disposed of according to good husbandry practices. Feeds or feeding ingredients do not need to be destroyed simply because they were near (or in contact with) suspect or confirmed animals. However, if it is determined that feeds or feed ingredients contain rendered animal protein originating from suspect or confirmed animals, or that the feed or feed ingredient has

October 1998

BSE Red Book 2.1-31

been epidemiologically linked to known BSE outbreaks, then the feeds or feeding ingredients should he destroyed and disposed of by incineration. Other steps that should be adhered to are the following:

*Federal, State and local policies concerning the feeding of rendered ruminant or other mammalian protein to ruminants should be closely followed.

*In light of recent preliminary research findings concerning maternal transmission, farmers should be advised to promptly remove and incinerate or bury placentas from calving pens. Calving pens should be cleaned and disinfected. The disinfectants of choice are 4-percent sodium hydroxide or 2-percent available chlorine.

6.4 Establishment of Quarantine Zone or Buffer Zone

Epidemiologic evidence indicates that the primary route of BSE transmission is via infected meat and bone meal that is used in the rations. Thus there is no need to establish a quarantine or buffer Zone surrounding the affected premises.

6.5 Quarantine of Public Livestock Concentration Points

Livestock concentration points should be notified and employees should be educated concerning the clinical signs of BSE. Any animal exhibiting signs indicative of the disease should be reported. All bovids showing evidence of neurological disease should be placed in an observation facility within the premises. If the clinical signs are sufficiently advanced, the animal should be euthanized and its tissues should be submitted for examination. The carcass should be incinerated or buried and must not be rendered. Due to the modes of disease transmission, there is no need to quarantine livestock at concentration points.

6.6 Quarantine at Slaughter Plants

BSE is not known to be contagious or vector berne. Therefore, it is not necessary to quarantine slaughter plants. Food Safety and Inspection Service and slaughter-plant employees should be notified and educated concerning BSE. Any animal exhibiting signs suggestive of the disease should be reported. All CNS suspects should be isolated in a facility where the animals can he adequately observed. The animal should be euthanized and tissues submitted for examination. The carcass should not permitted to enter the human or animal food chain. If laboratory diagnostic tests have ruled out BSE the carcass may be rendered. In the event of a presumptive diagnosis or a confirmed diagnosis of BSE, notify FDA, CVM if carcasses have moved to rendering or animal feed manufacturing plants.

October 1998

BSE Red Book 2.1-32

6.7 Moratorium on Animal Movements

No moratorium on the movement of animals (except as required by the provision of the quarantine on affected herds) is necessary. However, if animals from the same herd are presented for slaughter, those carcasses should be held. Consult VS, Emergency Programs staff.

6.8 Veterinary Practitioners Operating in a Quarantine or Buffer Zone

A quarantine zone or buffer zone is not necessary in case of a BSE outbreak, but the area must be geographically identified if the BSE cases were domestic cases; similar feeding practices in the area may be a risk factor. Veterinary practitioners throughout the United States should be alerted and encouraged to report all animals with suspicious signs. The Regional Emergency Animal Disease Eradication Organization (READEO) director and the local AVIC or designated personnel should have the responsibility for notifying all private practitioners in the outbreak area after consultation with Emergency Programs staff. Guidelines for working with a CNS-suspect animal or a BSE-affected herd:

*Practitioners should immediately report to regulatory authorities any animal showing signs suggestive of ESE.

*Practitioners should wear clean coveralls and boots on each premises visited.

*If performing a caesarian section, assisting with the calving of a BSE suspect, or performing this work on an infected farm, the practitioner should wear gloves and eye protection.

*If no FAD deagnostician or pathologists are available and the veterinary practitioner must remove the brain of a CNS suspect for diagnostic submission, every precaution should be taken to prevent exposure of the skin or mucous membranes because rabies cannot be ruled out. Practitioners should record all clinical signs and their progression. Veterinarians who need to visit premises under quarantine for BSE should be allowed to do so and should observe normal disease control precautions. They should wear clean overalls or similar apparel and rubber hoots. Boots should be cleaned with an approved and registered disinfectant before entering and when leaving a premise. Thermometers, restraint devices (tongs), and other equipment should be disinfected between premises as other contagious diseases cannot be ruled out.

6.9 Artificial Insemination, Germ Plasm Collection, and Embryo Transfer

The role that germ plasm plays in the transmission of the spongiform encephalopathies, especially BSE, is still unclear. Studies involving bovine semen and embryos are in progress and to date have revealed no evidence of playing a role in the transmission of BSE. Due to recent experimental evidence that scraple

October 1998

BSE Red Book 2.1-33

may be transmitted by embryos, precautions against BSE transmission by ova and embryos are reasonable (Foster et al. 1992 and 1996). All semen, ova, and embryos produced by BSE--confirmed animals should be located, inventoried and destroyed if the owner is agreeable. If an owner of semen, ova, and embryos from a BSE-confirmed animal is not willing to have these materials destroyed, guidance must be sought from VS, Emergency Programs staff at once. Field personnel should not offer indemnity for semen, ova, or embryos unless authorized by Emergency Programs. Normal reproductive activities, including semen and ova collection, natural and artificial insemination, and embryo transfer, may be allowed to continue during the quarantine period on premises that have had BSE-confirmed animals. However, movements of semen, ova, or other germ plasm collected on the premises with confirmed cases of BSE should be restricted until the quarantine is released.

6.10 Animal Protein Preservation

The carcasses from BSE-affected animals must not be used for human or animal consumption. Dispose of carcasses by environmentally acceptable methods, preferably incineration or deep burial. Consult VS, Emergency Programs and public health authorities if necessary.

6.11 Controlled Slaughter of Potentially Exposed But Clinically Unaffected Bovines

Cattle from premises under quarantine for BSE should not be slaughtered or rendered until the epidemiologic investigation has been completed and the quarantine has been lifted. Depending on the findings, the herd may be purchased for research or depopulation.

6.11.1 Control of Animal Products From Affected Premises Even if public health regulations allow, utilization of products of clinically healthy animals from quarantined premises should not be transported and processed for human consumption (except milk) during the quarantine period.

6.11.2 Meat Products Meat from BSE-suspect animals must not be used for human or animal consumption or enter the rendering chain.

6.11.3 Offal Federal, State, and national rendering policies and FDA regulations concerning the use of viscera and rendered proteins in animal feeds and human food must be followed. Cooperation from other Government agencies involved, as well as the rendering industry, is very important.

October 1998

BSE Red Book 2.1-34

6.11.4 Skins or Hides Skins or hides from healthy or exposed animals are not a risk for spreading BSE. Normal processing precautions should be observed.

6.11.5 Milk Milk from BSE-suspect animals should not be used for human consumption. Milk from clinically healthy animals may be pasteurized and used without further restriction. Public health officials should be informed.

6.12 Adjacent Premises

Area spread of BSE by vectors or other methods is not known to occur. Therefore, quarantine of adjacent premises is not necessary.

6.13 Guidelines for Zoologic Parks and Exhibitions

Zoologic parks where transmissible spongiform encephalopathies have been confirmed should be handled in a manner similar to that of beef or dairy farms. Confirmed operation of the park and public access may be continued. Affected animals should be isolated and observed for the progression of the clinical signs before a final disposition is made.

6.14 Quarantine Release

After the epidemiologic investigation has been completed and decisions are made concerning the disposition of the herd, the quarantine may be released. At the beginning of an outbreak, it is strongly recommended that the Government purchase affected herds for research and observation.

October 1998

From: Terry S. Singeltary Sr. (216-119-138-129.ipset18.wt.net) Subject: Emergency Operations...BSE Red Book Date: March 13, 2000 at 1:30 pm PST

BSE Red Book 2.1-35

7.0 Emergency Operations

The section below would be implemented only after a first case of BSE is confirmed in the United States.

7.1 READEO Activation

READEO activation will rarely be necessary for BSE outbreaks. Different from most other foreign animal diseases and infectious diseases, BSE is not a rapidly spreading, acute epizootic; is not thought to be transmitted horizontally between animals within a herd, has an extremely long incubation period, and usually affects only isolated single animals or, at most, a few animals within herds. Because BSE does not spread rapidly, the workload to investigate and manage most outbreaks should not normally exceed the capability of existing local field personnel. READEO activation should be considered only if the particular circumstances of a BSE outbreak warrant. If field personnel feel they are unable to manage a BSE outbreak, they should communicate this to their Regional Director and VS, Emergency Program staff, who will evaluate the need for READEO activation.

7.2 READEO Organization

If READEO is activated, a reference should be made to the revised READEO Manual for further guidance on READEO organization and operations.

7.2.1 Office of the Director When an animal disease emergency exists, the Task Force Directors are responsible for the READEO activities. The directors immediately move to the location of the outbreak and setup the READEO headquarters. Work is coordinated with State officials of the States involved in the outbreak. 7.2.1.1 State Director--(Note: This is the new designation for the Assistant Director.) Each READEO may have one or more State Directors since each State where the disease outbreak is found will be represented in the READEO by State officials designated by the State Veterinarian. 7.2.1.2 Emergency Program Officer--This individual, designated by the Chief Staff Veterinarian of VS, Emergency Programs, provides liaison between the READEO and the Emergency Programs at APHIS headquarters. 7.2.1.3 Public Affairs Officer--The Public Affairs Officer plans, develops, supervises, and maintains information activities for the READEO. 7.2.1.4 Legal--The Legal Advisor provides counsel and assistance to the READEO. 7.2.1.5 Military--The U.S. Armed Forces Command will designate a senior line officer to be the Military Support Officer on the staff of the READEO Task Force Directon The individual is assigned to be the liaison between the Depart-

October 1998

BSE Red Book 2.1-36

ment of Defense and VS, Emergency Programs,and to coordinate needed military assistance during eradication of an FAD outbreak. 7.2.1.6 Meat and Poultry Inspection Operations--The Meat and Poultry Inspection Operations, Food Safety and Inspection Service, will designate personnel to report to the READEO Task Director and to provide liaison between the Task Force and the Meat and Poultry Inspection Operations. 7.2.1.7 Laboratory Coordination--The Laboratory Coordination Officer will advise the READE(3 Director concerning laboratory capabilities and appropriate laboratory examinations to be conducted to provide needed results as rapidly as possible. This individual will assist with interpretation of results.

7.2.2 Administration The Administrative Officer assigned to the READEO will direct and coordinate all facets of general administrative functions. Refer to the revised READEO Manual for a detailed description of the organization and responsibilities.

7.2.3 Field Operations The Field Operations Officer will direct line operations and supervise field personnel in a READEO. Disease investigation, field epidemiology, disease security and personnel security, animal movement control and quarantine enforcement, appraisals of animals and materials, depopulation and disposal, and cleaning and disinfection are among this person's responsibilities.

7.2.4 Technical Support Staff support consists of a technically competent staff designed to act as a resource for the READEO Task Force. Personnel may include but are not limited to individuals who have expertise in the following areas: animal welfare, data systems, disease reporting, economics, environmental impact, epidemiology, evaluation, orientation and training, risk analysis, and wildlife. The staff communicates the needs of the Field Epidemiology Delivery System (FEDS) to the READEO Director as required to maintain an efficient, accurate, up-to-date FEDS. 7.2.4.1 Animal Welfare---Animal Welfare Officers must be knowledgeable about current Federal and State animal welfare regulations, humane methods of animal depopulation, and socioeconomic concerns related to animal welfare issues. They advise the technical support staff and field operations concerning current procedures and accepted methods for use in the humane depopulation of livestock and poultry. 7.2.4.2 Wildlife-- Wildlife Officers participate with the Director and other officials of the READEO to establish and carry out wildlife policies and objectives for the emergency animal disease operation. Through familiarity with the topography, wildlife density, susceptible wildlife species, and movements of susceptible wildlife, the Wildlife Officers can review maps and make recommendations concerning areas to be included in the quarantined high-risk and buffer zones. These officers maintain contact with local, State, and Federal wildlife enforcement officers and wildlife biologists. They develop strategies for conducting surveys of susceptible wi!dlife in the outbreak

October 1998

BSE Red Book 2.1-37

area to determine the incidence of the disease. They direct and coordinate the vaccination and depopulation of wild animals as necessary to eliminate the disease.

7.3 Supplies and Equipment

During an outbreak of BSE, supplies and equipment should be obtained through normal procurement procedures. If a READEO is activated, supplies and equipment should be ordered through the READEO Procurement and Supply Officer.

7.3.1 General Field Supplies Guidelines Refer to APHIS Directive 326.1, 10/10/77 and 221.1, 1/29/74.

7.4 Personnel Responsibilities

During a BSE outbreak, field personnel should follow instructions issued through the normal chain of command. If a READEO is activated, personnel should refer to the revised READEO Manual for detailed descriptions of individual responsibilities.

7.4.1 Personnel Personnel assigned to the READEO Task Force are individually accountable for equipment and supplies checked out to them. They should order replacement equipment and supplies or return equipment for repairs through the READEO Procurement and Supply Officer. All damages or losses to equipment or vehicles should be reported immediately to the READEO Administrative Officer, and the required forms should be completed and submitted promptly.

7.4.2 Travel Employees of the READEO Task Force are responsible for recording and preparing all travel-related documents. Claims for travel, lodging, per diem, and incidental expenses should be submitted to the READEO Administrative Officer for processing.

7.4.3 Vehicles Employees of the READEO Task Force are responsible for operating, cleaning, and performing routine maintenance of assigned vehicles. They also are responsible for recording mileage, expenses, and services. Required reports are to be submitted to the READEO Vehicle Officer.

7.4. 4 Clothing Employees of the READEO Task Force are issued protective clothing to wear when entering a premises where BSE has been diagnosed or is suspected. Clean clothing should be worn on each premises. Employees are responsible for laundering the clothing before reusing it.

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BSE Red Book 2.1-38

In a large task-foree operation, arrangements may be made for a commercial laundry service to handle the clothing. If it is possible and practical, all clothing should be labeled to identify the employees to whom it is assigned.

7.4.5 Miscellaneous Responsibilities Employees are responsible for conducting their assigned tasks in a professional manner. Complaints concerning task force employees should be directed to the READEO Director for resolution or appropriate action.

All animals, products, and materials to be destroyed because of BSE should be appraised according to 9 CFR 53.3 and appropriate State regulations.

7.5.1 Appraisal Teams Appraisals must represent the interests of the owner, the State, and the Federal Government and be consistent with fair market values. If State authorities approve, State and Federal interests may be represented by a VS employee alone. Owners may, at their discretion and expense, employ a professional appraiser to advise them or to act as their agent. Either the owner or the owner's agent must be present at appraisals. No animals may be destroyed until after the appraisal forms are signed by the owner or the owner's agent. Appraisers should be certain that the owner or the owner's agent is aware of the indemnity form's clause concerning liens and mortgages. When the number of animals to be destroyed is small, and the total value of animals, products, and materiais is low, APHIS field personnel may negotiate the appraised value with the animal's owner without assistance from a professional appraiser. The appraised value of a BSE suspect should be the slaughter value of the animal, taking into account any existing defects or diseases that would affect the slaughter value but ignoring those signs that caused the animal to be classified as a BSE suspect. If field personnel are in doubt concerning the need to use a professional appraiser, they should consult their supervisor or VS, Emergency Programs staff. If a determination is made that healthy progeny, ova, semen, or embryos must be destroyed, they should be appraised at 100 percent of replacement value. Feeds or feed ingredients located on suspect farms will rarely need to be destroyed. If a determination is made that feeds or feed ingredients must be destroyed (for example, to comply with a policy decision to remove all rendered products from animal feeds), then these materials should be appraised and indemn'ff~ed according to 9 CFR 53.3.

October 1998

BSE Red Book 2.1-39

7.6 Depopulation Procedures

7.6.1 Factors and Considerations If the owner is agreeable, a humane method of euthanasia of BSE suspects will be necessary to facilitate the accurate diagnosis of the disease problem, to ensure that the suspect animal is not slaughtered or rendered, and to terminate the animal's suffering. Under no circumstances may BSE suspects be sent fo slaughhter or rendering. Notify FDA, CVM if you suspect that the carcass of a BSE-confirmed animal has moved to rendering or animal feed manufacturing. The VS, Emergency Programs staff, Riverdale, MD, must authorize the use of euthanasia, depopulation, and indemnity payments for READEO operations.

7.6.2 Humane Euthanasia Methods Only experienced veterinarians should perform euthanasia because there are inherent dangers. Precautions should be taken to prevent accidents. Owners should be given a complete explanation of what to expect, and only humane euthanasia methods should be used. Euthanasia should be performed away from public view, and, if possible, the owner should not be present. Euthanized animals must be checked to confirm death. (See VS Memo 583.1, 1992.) 7.6.2.1 Mechanical (Firearms)--Because the only acceptable method for euthanizing an animal by using firearms is to shoot it in the head, and because the animal's brain must be preserved to diagnose BSE, firearms are not an acceptable euthanasia method. 7.6.2.2 Chemicals(Toxic Gas or Lethal Injection)--Follow guidelines established by the American Veterinary Medical Association. When using a regulated controlled substance (e.g., barbiturates), control and administration of the euthanasia agent must be given by a veterinarian having a Drug Enforcement Administration (DEA) number issued by the U.S. Treasury. Control and administration of chemical substances for euthanasia must be authorized by the AVIC unless directed by the VS Deputy Administrator. (See VS Memorandum 583.1, 1992.)

7.6.3 Supervision of Depopulation Field personnel should never perform depopulation or euthanasia without explicit permission from their supervisor or, if appropriate, the READEO Humane and Disposal Officer. (Refer to the revised READEC) Manual.)

7. 6.4 Permits for Movement All BSE suspects may be moved under permit to facilitate medical treatment, euthanasia, necropsy examination, or carcass disposal. Permitted movement will be according to the quarantine restrictions and will be administered by the State or Federal officials.

7. 6. 5 Security Because BSE is neither contagious nor vector borne, strict disease security measures are not necessary. Personnel should observe normal disease security measures that are standard procedure for all farm visits. The READEO's Security and Disease Prevention Officer has the responsibility for establishing biosecurity measures.

October 1998

BSE Red Book 2.1-40

7.7 Disposal Under no circumstances may BSE suspects be sent to slaughter or rendering. Notify FDA, CVM if you suspect that the carcass of a BSE-confirmed animal has moved to rendering or animal feed manufacturing. Field personel should arrange for the carcass to be transported to and examined by a qualified veterinary pathologist or field veterinary medical officer. After the pathologic examination has been completed and the necessary diagnostic specimens have been obtained, field personnel should arrange for disposal of the carcass. Before a method of disposal is selected, there are many factors that must be considered, and often other State and Federal agencies must be consulted. The environmental and legal impacts of the operation must be considered. Upon recommendation of the State or Federal agencies, VS may consider other disposal methods.

7.7.1 Incineration Incineration, although more expensive than burial, is the preferred disposal method for BSE-suspect carcasses. Federal, State, and local environmental regulations may restrict the use of this method and permits may be necessary. As soon as BSE suspects are reported to APHIS, field personnel should investigate the location and availability of incinerators of sufficient size to process a bovine carcass. Institutions likely to have incinerators include State and university diagnostic laboratories, waste contractors, large municipalities, and private industries. Ideally, the diagnostic laboratory where the pathologic examination was done will have incineration facilities. The BSE-suspect carcass disposal is APHIS' responsibility (not the diagnostic laboratory's). Field personnel should arrange for transportation and final disposal of the suspect carcass and should inform their supervisors and/or the READEO Humane and Disposal Officer of these arrangements. Personnel should be aware that some laboratories dispose of carcasses by rendering and should specifically inquire if this is the case. CNS suspects should be incinerated or held from rendering until a diagnosis of BSE can be ruled out. Under no circumstances may BSE susuects be sent to slaughter or rendering. Notify FDA, CVM if you suspect that the carcass of a BSE-confirmed animal has moved to rendering or animal feed manufacturing. Field personnel should be prepared to accompany the carcass from the farm of origin to the diagnostic laboratory and then to the disposal site if any doubt exists concerning the final disposal method.

7.7.2 Burial If there are no other avenues for carcass disposal, burial of BSE-suspect carcasses may be an acceptable disposal method. APHIS field personnel should inquire with environmental authorities concerning Federal, State, and local regulations that may impose restrictions on this method. The burial site may be on the affected farm, at the diagnostic laboratory where the carcass is examined, or in a local landfill. The site should be inaccessible to animals, removed from populated areas, not used for agricultural purposes, clearly marked, and properly protected.

October 1998

BSE Red Book 2.1-41

Burial sites should also be located a sufficient distance from underground utility lines, septic systems, water wells, and surface water. Local environmental or public works officers may be helpful in locating a satisfactory site. Field personnel should consult with their supervisors and/or the READEO Environmental Impact Officer before digging. Burial trenches are normally at least 9 feet deep with floor dimensions of 7 by 2 feet per adult bovine carcass. Carcasses should be covered with at least 6 feet of soil. This soil should not be tightly packed because gas formation may cause a tightly packed trench to crack and leak.

7.7.3 Rendering Because BSE is spread by rendered animal protein, BSE-suspect and confirmed carcasses must not be rendered, unless the rendered material is incinerated. Notify FDA, CVM if you suspect that dead BSE animals or carcasses have moved to rendering or animal feed manufacturing.

7.7.4 Other Disposal Methods The AVIC, the State animal health officials, and the READEO Director may recommend other methods of disposal to the Deputy Administer, VS, for approval (9 CFR 53.4). Options for disposal must be discussed and approved by VS, Emergency Programs staff and must comply with all State and local Environmental Protection Agency regulations.

7.8 Cleaning and Disinfecting (C&D)

Although BSE is neither contagious nor vector borne, appropriate C&D is required to prevent farm-to-farm transmission of most other infectious diseases. Field personnel must remember, however, that at the time they are requested to euthanize a BSE-suspect animal, a confirmed diagnosis of BSE will not be available. Signs compatible with BSE may be caused by numerous infectious diseases and many BSE-suspect animals will, in fact, have some other disease. Although the C&D of items such as manure, bedding, feed, stalls, halters, milking machines, and other supplies and equipment that have been in contact with BSE suspects is not specifically necessary to control BSE, C&D is still advisable to control other diseases that may be present.

7.8.1 Procedures for Cleaning and Disinfecting 7.8.1.1 Premises and Items--Field personnel are not responsible for C&D of premises such as barns, stalls, and animal pens unless invasive diagnostic procedures (such as a necropsy examination or the removal of the suspect animal's brain) were performed on the premises. If possible, field personnel should avoid doing such procedures on the farm. If circumstances require that such procedures must be done on the farm, personnel should clean and disinfect the immediate area after completing the work. 7.8.1.2 Vehicles--Vehicles used to transport personnel to affected premises should be kept clean, and normal precautions against the farm-to-farm spread of any disease should be observed.

October 1998

BSE Red Book 2.1-42

7,8.1.3 Carriers--Thoroughly clean trucks and trailers transporting BSE suspects. Manure and bedding may be disposed of by any environmentally accepted method such as spreading on fields or composting. After conveyances have been thoroughly cleaned, disinfectant should be sprayed on the sides and floor of the truck bed. 7.8.1.4 Livestock Markets--The risk of BSE transmission at livestock markets is negligible. If a BSE suspect is found at a livestock market, it should be managed the same as if it were found at a farm. Because of the high risk of transmission of diseases other than BSE, invasive diagnostic procedures, such as a necropsy examination or removal of the suspect animal's head, should not be performed at livestock markets. Due to the recent research findings concerning maternal transmission, any pens or areas in which calving occurs should be thoroughly cleaned and disinfected. Cleaning and disinfection is not necessary to prevent the spread of BSE. However, the C&D procedures are recommended to prevent the spread of other diseases from pens or buildings where BSE suspects were held. 7.8.1.5 Slaughter Plants--Becanse BSE is spread by rendered animal protein in cattle feeds, BSE suspects must not be slaughtered nor rendered. If a BSE suspect is found at a slaughter plant, it should be managed similarly to finding a suspect at a farm.

7.8.2 Approved Disinfectants Field personnel should use professional judgment in the choice of a disinfectant. Preferred disinfectants to inactivate the BSE agent include 1N sodium hydroxide solution or sodium hypochlorite solution containing 2 percent chlorine (1 hour exposure at 20 %C [68 %F]). This should be used whenever there is reason to strongly suspect that BSE is in fact the cause of the suspect animal's disease. Such reasons include previously confirmed BSE in the geographic area or signs more compatible with BSE than with any other neurologic disease. If the suspect animal's signs are more compatible with diseases such as rabies or listeriosis, then a phenolic disinfectant such as "One Stroke" may be preferable. (Refer to appendix A Survival of BSE Agent and sec. 1.4.4.)

7. 8. 3 Precautions All disinfectants are hazardous to human beings, animals, and the environment. Label directions should be carefully read and followed. Many disinfectants, including sodium hypochlorite solution, are also corrosive and should be used with caution on metal and other corrodible materials. Thorough rinsing is necessary if corrosive disinfectants are used on metallic items. Disinfectants, especially in concentrated form, may irritate skin, eyes, and respiratory systems. Protective equipment such as appropriate clothing, rubber boots, rubber gloves, mask and goggles should be worn during mixing and application of disinfectants. If areas of the body are exposed to a disinfectant, they should be washed thoroughly with water. Employees should notify their supervisor and their Health and Safety Officer if excessive human or animal exposure to disinfectants occurs or if there is accidental release into the environment.

October l998

BSE Red Book 2.1-43

Field personnel should use normal hygienic procedures (such as washing and disinfecting boots and removing the outer layer of clothing) when leaving the farm. Unless the disease problem is noncontagious, personnel should not travel to other livestock premises for the duration of that day.

7.9 Vector Control

Current scientific data indicate that BSE is not spread by vectors.

7.10 Disease Prevention and Philosophy

The goal of disease prevention and control is to confine the occurrence of BSE to as few herds as possible and to prevent recycling of the BSE agent in the ruminant food supply. If undiagnosed cases are rendered and included in ruminant rations, the long incubation period may allow many animals to be exposed. Action should be taken immediately after the detection and confirmation of BSE to initiate an extensive epidemiologic investigation to determine the source and extent of the disease, to stop the spread, and to eradicate the disease. 7.10.1 Philosophy--Immediate action should be taken to prevent contamination of the animal food supply by prohibiting rendering of any infected or suspect bovine carcasses. In addition, care should be taken to monitor those animals born and raised in affected herds and to prevent their becoming a source of infection to other herds. 7.10.2 Agent Spread--Epidemiologic evidence indicates that the primary route of BSE transmission is through the feeding of contaminated meat and bone meal that has been manufactured using scrapie infected sheep carcasses or BSE infected bovine carcasses. Recent research findings suggest that maternal transmission may occur at a rate of approximately 1 percent in some species. It is believed that this route of transmission is not significant enough to maintain an epidemic. Cases of apparent maternal transmission have also been identified in captive exotic ruminants. 7.10.3 Control of Products and Conveyances--Carcasses of BSE suspects should be incinerated. Carcasses must not be rendered and incorporated in animal feed. If carcasses are transported for disposal, conveyances should be cleaned and disinfected after use with either a sodium hypochlorite solution (2 percent available chlorine) or 1 N lye (sodium hydroxide solution). 7.10.4 Control of Biologics and Drugs--Although no documented cases of BSE have resulted from the use of biologics derived from bovines, tissues from suspect or exposed animals must not be used for the production of biologics and drugs. The agents responsible for causing the transmissible spongiform encephalopathies are highly resistant to normal inactivation processes. Careful selection of source materials is the best way to secure maximum safety of ingredients or reagents of bovine origin used in the manufacture of biologics or other medicinals. Factors that should be considered are the age of the animals, exposure to the agent, and the tissue or organ from which the product is derived.

October 1998

BSE Red Book 2.1-44

7.10.5 Wild Birds, Wind and Insects---Wild birds, wind and insects are not known factors in the spread of BSE. 7.10.6 Rodents--Rodents are not known factors in the spread of BSE. 7.10.7 Hunting--Restrictions on the hunting of wild animals are not necessary to prevent BSE. 7.10.8 Exhibitions--Cancelling scheduled exhibitions is not necessary. 7.10.9 Rendering Trucks and Drivers--The carcasses from BSE suspects must not be rendered. If any rendering truck is used to transport a suspect, it should be cleaned, washed, and disinfected as above. (Refer to appendix A--Agent Survival and sec. 7.8.2--Disinfectants.) 7.10.10 Treatment--Currently there is no known treatment for BSE. 7.10.11 Prevention--Suspects and animals confirmed to have BSE must not be rendered. Producers, feed mills, and rendering establishments should adhere to U.S. State and local rendering policies and FDA regulations concerning the feeding of rendered animal protein to ruminants. Because of the possibility that some transmissible spongiform encephalopathies may be transmitted at the time of parturition, precautions should be taken to prevent exposure of healthy animal to placenta and reproductive fluids. Importation of live animals and animal products from countries with BSE or having high risk factors for BSE should be restricted based upon scientific risk assessment. 7.10.11.1 Immunization--The agent that causes BSE elicits no detectable immune response in the host. Therefore, vaccination is not a viable option. There is no vaccine currently developed for BSE or other TSE's. 7.10.11.2 Sanitation--Although it is unknown whether a contaminated environment plays any role in the spread of BSE, it is suggested that pens having contained BSE-infected animals be cleaned and disinfected. The disinfectants o choice are sodium hydroxide (lye) and sodium hypochlorite, in infected herds it is also advisable that all placentas be removed promptly and buried or incinerated. The calving pens also should be cleaned and disinfected. 7.10.113 Producer Defense---The most effective way to prevent an intruduction of BSE into a herd is not to feed ruminant byproducts to ruminants. As of August 4, 1997, the FDA has a ban in place which prohibits the feeding of most mammlian proteins to ruminants.

7.11 Records Maintenance in a Foreign Animal Disease Outbreak

The APHIS FEDS will be used by the READEO to record information. FEDS a computerized network designed to transmit accurate information rapidly during any emergency disease outbreak. The use of FEDS will allow the READEO to direct its attention to the minute-to-minute business of containing and eradicating the disease. For an accurate record of the activities, all field supervisors in a READEO task force should maintain a diary. Activities and observations should be recorded in the diary when they occur. Date all documents and enter events by time and date to show a correct chronology. Enter events as they occur in the diary as well. An accurate history is of considerable value in developing policies and plans for future disease-eradication

October 1998

BSE Red book 2.1-45

programs, and it may be important if there is litigation. A diary will be helpful for day-to-day administration of funds, personnel, and equipment. It is also useful as a later reference in preparing reports and summaries of activities.

7.11.1 Daily Reporls Submit daily reports of significant activities to the READEO Director and the VS, Emergency Programs staff Riverdale, MD. (Refer to appendix F for current telephone listings.) Include the following as part of the historical file of an outbreak:

*Maps showing premises where BSE-infected animals were found; *Inventory of feeds and feed sources; *Origin of BSE-suspeet and confirmed animals; *Public information material distributed, newspaper clippings; and, Administrative reports to support the expenditure of funds, utilization of personnel and equipment, and disposition of excess materials and equip­ment at the end of the program.

7.11.2 Distribution The VS, Emergency Programs staff will distribute reports of significant activities to all AVIC's, State cooperators, and industry cooperators at least weekly. As soon as significant events occur, Emergency Programs will inform all APHIS

From: Terry S. Singeltary Sr. (216-119-138-129.ipset18.wt.net) Subject: Re: Emergency Operations (part 2)...BSE Red Book Date: March 13, 2000 at 1:34 pm PST

In Reply to: Emergency Operations...BSE Red Book posted by Terry S. Singeltary Sr. on March 13, 2000 at 1:30 pm:

will inform all APHIS headquarters units through normal reporting channels. Emergency Programs also will immediately report any significant events to the Deputy Administrator, VS, who will immediately advise the APHIS Administrator, especially of legal or politically important events. A weekly summary report of control and eradication activities will be provided to the APHIS Administrator and the Deputy Administrator, VS. See BSE Response Plan, communications section.

7.11.3 Disposition Records should be maintained until a historical account of the program has been prepared and all pertinent information has been gleaned from the records. Furthermore, all records should be maintained if there may be legal action pending as a result of the program activities. Usually, administrative records are maintained a minimum of 3 years for audit purposes.


=======================END...TSS...2008==============


Saturday, August 16, 2008

A Quantitative Assessment of the Possible Role of Nonambulatory Cattle in Transmissible Spongiform Encephalopathy in the United States March 6, 2000 at 1:05 pm PST

http://downercattle.blogspot.com/2008/08/quantitative-assessment-of-possible.html


EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)

Summary of the Scientific Report

The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in the United States of America, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in USA. This scientific report addresses the GBR of USA as assessed in 2004 based on data covering the period 1980-2003.

The BSE agent was probably imported into USA and could have reached domestic cattle in the middle of the eighties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early nineties. It is possible that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to an internal challenge in the early nineties.

A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk countries were slaughtered or died and were processed (partly) into feed, together with some imports of MBM. This risk continued to exist, and grew significantly in the mid 90's when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries.

EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases.


http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/573.html


http://www.efsa.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/573.Par.0004.File.dat/sr03_biohaz02_usa_report_v2_en1.pdf


snip...see full text ;

June 12, 2008

FEDERAL OVERSIGHT OF FOOD SAFETY

FDA Has Provided Few Details on the Resources and Strategies Needed to Implement its Food Protection Plan

What GAO Found

http://fdafailedus.blogspot.com/


http://fdafailedus.blogspot.com/2008/06/federal-oversight-of-food-safety-fda.html


Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518