> may have received beef from more than one source. USDA
> determined that
> 176 customers on the lists did not actually receive
> recalled beef,
> including
> the customers in Guam and Hawaii. USDAs review also
> indicated that
> recalled beef was probably not shipped to Alaska or
> Utah, and USDA
> checked 2 retailers in Alaska and 3 retailers in Utah
> to confirm that
> was the
> case. In total, USDA conducted verification checks on
> 537 of the 713
> customers on the lists. USDAs initial checks
> identified an additional 45
> customers that may have received the recalled beef
> that were not included
> on the distribution lists, for a total of 582
> verification checks. Figure 4
> summarizes USDAs verification efforts during the
> recall.
> Appendix II
> Federal Actions Associated with the
> Discovery of an Animal in the United States
> Infected with BSE
> Page 43 GAO-05-51 Food Recall Programs
> Figure 4: USDAs Recall Verification Checks by
> Location and Customer
> Type for Meat Associated with the Animal Infected with
> BSE
> Note: USDA checked 15 primary, 40 secondary, and 526
> tertiary customers
> plus the recalling
> company, for a total of 582 verification checks.
> USDAs press release stated that the recall involved
> 10,410 pounds of beef
> products, and the USDA recall coordinator for this
> recall told us that
> downstream processors mixed the recalled beef with
> nonrecalled beef, for
> a total of more than 38,000 pounds of beef that was
> distributed at the
> secondary customer level. According to USDA officials
> involved with the
> D = Distributor
> R = Retailer
> SF = Storage facility
> P = Processor
> Primary customers
> (15 total)
> Recalling
> slaughterhouse
> (WA) 1 R
> (OR)
> 1 P
> (WA) 1 P
> (OR)
> 1 P
> (OR)
> 11 R
> (WA)
> Secondary customers
> (40 total)
> Tertiary customers
> (526 total)
> 1 R
> (OR)
> 1 SF
> (OR)
> 3 D
> (OR)
> 3 D
> (WA)
> 2 dual D
> (OR)
> 59 R
> (OR)
> 79 R
> (WA)
> 5 R
> (ID)
> 3 R
> (UT)
> 4 R
> (MT)
> 161 R
> (WA)
> 8 R
> (ID)
> 15 R
> (OR)
> 2 R
> (AK)
> 31 R
> (OR) 8 R
> (WA)
> 10 R
> (NV)
> 5 R
> (ID)
> 10 R
> (CA)
> 2 R
> (CA)
> 17 R
> (OR)
> 5 R
> (WA)
> 1 D
> (NV)
> 11 R
> (CA)
> 85 R
> (NV)
> 3 D
> (OR) 11 R
> (OR)
> 2 D
> (CA) 26 R
> (CA)
> 2 R
> (WA)
> ( ) Acronyms in parentheses are postal abbreviations
> for each state.
> Source: GAO analysis of USDA verification check
> documents.
> Appendix II
> Federal Actions Associated with the
> Discovery of an Animal in the United States
> Infected with BSE
> Page 44 GAO-05-51 Food Recall Programs
> recall, the precise amount of meat that was sold at
> the retail level is
> unknown because retailers at the tertiary level
> further mixed nonrecalled
> meat with potentially contaminated meat. USDA told us
> that more than
> 64,000 pounds of beef was ultimately returned or
> destroyed by customers,
> and that, because of the mixing, it was not able to
> determine how much of
> the original 10,410 pounds of recalled beef was
> contained in the 64,000
> pounds that were recovered.
> FDAs Role in USDAs
> Recall
> Parts of the BSE-infected animal slaughtered on
> December 9, 2003, were
> not used for food, but they were sent to renderers to
> be separated into raw
> materials, such as proteins and blood. Rendered
> materials are used for
> many purposes, including cosmetics and vaccines. FDA
> has jurisdiction
> over renderers.
> When USDA learned of the BSE-infected cow on December
> 23, 2003, the
> agency immediately notified FDA. On December 24, 2003,
> FDA sent an
> inspection team to a renderer that handled materials
> from the BSE cow.
> Inspectors confirmed that the parts of the slaughtered
> BSE positive cow
> were on the premises. FDA later identified a second
> company that
> potentially rendered material from the slaughtered BSE
> cow. Both
> renderers agreed to voluntarily hold all product
> processed from the
> diseased cow and dispose of the product as directed by
> FDA and local
> authorities.
> On January 7, 2004, 15 containers of potentially
> contaminated, rendered
> material (meat and bone meal) were inadvertently
> loaded on a ship, and on
> January 8, 2004, the ship left Seattle, Washington,
> for Asia. The renderer
> initiated steps to recover the shipped material, so it
> could be disposed
> of as
> directed by FDA and local authorities. The ship
> carrying the material
> returned to the United States on February 24, 2004,
> and the material was
> disposed of in a landfill on March 2, 2004.
> On January 12, 2004, FDA asked both renderers to
> expand their voluntary
> holds to rendered materials processed from December
> 23, 2003, through
> January 9, 2004, because they may have rendered some
> recalled meat or
> trim that was recovered from retail establishments.
> Both renderers agreed
> to the expanded product hold. In total, FDA requested
> that renderers
> voluntarily hold approximately 2,000 tons of rendered
> material. FDA
> confirmed that none of the potentially contaminated,
> rendered material
> entered commerce, because FDA accounted for all
> rendered material. FDA
> Appendix II
> Federal Actions Associated with the
> Discovery of an Animal in the United States
> Infected with BSE
> Page 45 GAO-05-51 Food Recall Programs
> reported that no recall was necessary because no
> product was distributed
> commercially by the rendering companies.
> USDA and FDA
> Worked Together on
> the Recall
> USDA and FDA worked together in two ways. First, both
> agencies notified
> each other if their investigations yielded any
> information about products
> within the jurisdiction of the other agency. For
> instance, when conducting
> the second round of verification checks, USDA tracked
> the disposition of
> the product to renderers and landfills and notified
> FDA when the product
> went to renderers. Second, FDA officials helped
> conduct verification
> checks. FDA conducted 32 of the 582 verification
> checks (approximately 5
> percent) for the USDA recall. Officials from both
> agencies indicated they
> regularly interacted and shared information. Table 3
> outlines the agencies
> actions.
> Table 3: Detailed Timeline of USDA, FDA, and Company
> Actions Related to
> the Discovery of an Animal Infected with BSE
> Date USDA recall actions FDA actions Company actions
> 12/9/03 " USDA samples cow for BSE. " BSE cow is
> slaughtered.
> 12/11/03 " Sample is sent to Ames, Iowa, for BSE
> testing.
> " Recalling company sends
> carcasses to primary customer for
> processing.
> 12/12/03 " Primary customer sends meat
> products to two other primary
> customers for further processing.
> 12/12 -
> 12/23/03
> " Other primary customers distribute
> recalled product to secondary
> customers.
> " Secondary customers distribute
> recalled product to tertiary
> customers.
> 12/23/03 " BSE test results are presumptively
> positive.
> " Recall meeting.
> " Initiation of voluntary recall.
> " Press release.
> " FDA notified of BSE test results.
> " FDA dispatches investigation teams.
> 12/24/03 " FDA inspects Renderer 1.
> " FDA determines some rendered
> material from Renderer 1 is intended
> for Indonesia.
> " FDA discovers some material may
> have been sent to Renderer 2.
> " Renderer 1 agrees to hold remaining
> rendered material.
> " Recalling company contacts
> primary customers.
> " Primary customers contact their
> customers.
> Appendix II
> Federal Actions Associated with the
> Discovery of an Animal in the United States
> Infected with BSE
> Page 46 GAO-05-51 Food Recall Programs
> 12/25/03 " USDA receives confirmation from
> reference lab in England that cow in
> question is BSE positive.
> 12/26/03 " Verification checks begin
> " USDA announces recalled product in
> Washington State and Oregon.
> " FDA begins process of comparing
> records to ensure all products from
> Renderers 1 and 2 are accounted for.
> " Renderer 2 agrees to hold all material
> that may have been derived from
> BSE cow. None of the rendered
> material has been distributed.
> 12/27/03 " USDA announces recalled product was
> distributed in Washington State,
> Oregon, California, and Nevada.
> " FDA issues statement confirming that
> the rendering plants that processed
> all of the nonedible material from the
> BSE cow have placed a voluntary
> hold on all of the potentially infectious
> product, none of which had left the
> control of the companies and entered
> commercial distribution.
> 12/28/03 " USDA announces recalled product was
> distributed in Washington State,
> Oregon, California, Nevada, Montana,
> Idaho, Alaska, Hawaii, and Guam.
> 12/29/03 " Food Safety and Inspection Service
> determines that the recalled meat
> products were distributed to 42
> locations, with 80 percent of the
> products distributed to stores in
> Oregon and Washington State.
> 12/31/03 " FDA offers assistance to USDA to
> complete recall verification checks.
> 1/6/04 " USDA determines recalled product
> was only distributed in Washington
> State, Oregon, California, Nevada,
> Montana, and Idaho.
> 1/8/04 " FDA is notified by the renderer that
> some of the rendered material on
> hold from Renderer 1 was
> inadvertently shipped to Asia.
> Renderer 1 commits to isolate and
> return the rendered material.
> " Rendering company notifies FDA of
> shipment of product on hold.
> (Continued From Previous Page)
> Date USDA recall actions FDA actions Company actions
> Appendix II
> Federal Actions Associated with the
> Discovery of an Animal in the United States
> Infected with BSE
> Page 47 GAO-05-51 Food Recall Programs
> Source: GAO analysis of USDA and FDA information.
> 1/12/04 " FDA advises Renderers 1 and 2 that
> they may have rendered meat or trim
> subject to recall from retail stores.
> " FDA requests Renderers 1 and 2 to
> place all rendered material from
> December 23 to January 9 on hold.
> " FDA determines neither renderer had
> shipped rendered material
> manufactured after December 23,
> 2003.
> 2/9/04 " All rendered material was disposed of
> in landfill, except material shipped to
> Asia.
> 2/24/04 " Ship carrying rendered material
> returns to U.S. port.
> 2/25/04 " Verification checks complete.
> " USDA Boulder District Office
> concludes recall is effective.
> 3/1/04 " Recall is closed.
> 3/2/04 " FDA observes disposal in landfill of
> remaining rendered material...
>
> snip...
>
> REPORTS
>
> 1. Food Safety: USDA and FDA Need to Better Ensure
> Prompt and Complete
> Recalls of Potentially Unsafe Food. GAO-05-51, October
> 7.tss
> http://www.gao.gov/cgi-bin/getrpt?GAO-05-51
> Highlights -
> http://www.gao.gov/highlights/d0551high.pdf
>
>
> Greetings again,
>
>
> WITH politicians like Rep. Henry Bonilla, R-Texas,
> who needs assisted suicide law, his policy on COOL
> will
> have us all exposed to the mad cow agent. Nothing like
> being in the pockets of the packers and such, and
> dying
> old and demented, or maybe young and demented.
>
> WONDER how much the industry has donated to his
> campaign fund?
>
>
> I see here that the biggest contributor seems to be
> (i will give you 3 guess and the first 2 don't count);
>
>
> 2004
>
> Sector Total PACs Indivs
>
> Agribusiness $440,516 $296,566 $ 143,950
>
>
> http://www.opensecrets.org/politicians/sector.asp?CID=N00005985&cycle=2004
>
>
> let's break this down a bit;
>
>
>
> The top industries supporting Henry Bonilla are:
>
>
>
> #1 Livestock $131,900
>
> snip...
>
> #3 Lobbyist $91,147
>
> #4 Food Processing & Sales $90,140
>
> snip...
>
> #11 Agricultural Services/Products $60,800
>
> snip...
>
> #19 Dairy $36,750
>
>
> http://www.opensecrets.org/politicians/indus.asp?CID=N00005985&cycle=2004
>
>
>
> Henry Bonilla is a top House recipient from the
> following industries for the 2003-2004 election cycle:
>
>
> Livestock (#1)
>
>
> Meat processing & products:
> Top 20 Members of the House
>
>
> Election cycle: 2004
> Rank
>
> Candidate
>
> Amount
>
> #1
>
> Bonilla, Henry (R-TX)
>
> $32,250
>
>
> http://www.opensecrets.org/industries/recips.asp?Ind=A06&cycle=2004&recipdetail=h&Mem=Y&sortorder=U
>
>
>
> Meat processing & products:
> Top 20 Members of the House
>
>
> Election cycle: 20042002200019981996199419921990
> List Top 20: All RecipientsPresidential
> CandidatesSenatorsMembers of the HouseSenate
> CandidatesHouse CandidatesAll Members of Congress
> Rank
> Candidate
> Amount
>
> 1
> Bonilla, Henry (R-TX)
> $16,750
>
>
>
> http://www.opensecrets.org/industries/recips.asp?Ind=G2300&Cycle=2002&recipdetail=H&Mem=Y&sortorder=U
>
>
> Agricultural Svcs (#4)
>
> http://www.opensecrets.org/industries/recips.asp?Ind=A07&cycle=2004&recipdetail=h&Mem=Y&sortorder=U
>
> Dairy (#5)
>
> http://www.opensecrets.org/industries/recips.asp?Ind=A04&cycle=2004&recipdetail=h&Mem=Y&sortorder=U
>
> Food and kindred products manufacturing (#2)
>
> http://www.opensecrets.org/industries/recips.asp?Ind=G2100&cycle=2004&recipdetail=h&Mem=Y&sortorder=U
>
> Food Process/Sales (#2)
>
> http://www.opensecrets.org/industries/recips.asp?Ind=A09&cycle=2004&recipdetail=h&Mem=Y&sortorder=U
>
> Meat processing & products (#1)
>
> http://www.opensecrets.org/industries/recips.asp?Ind=G2300&cycle=2004&recipdetail=h&Mem=Y&sortorder=U
>
> Poultry & Eggs (#3)
>
> http://www.opensecrets.org/industries/recips.asp?Ind=A05&cycle=2004&recipdetail=h&Mem=Y&sortorder=U
>
> DO a search for his name ''Bonilla'' and then it gives
> you a bunch of different options to break down
> campaign contributions. His number 3 contributor is
> the National Cattleman's Beef Association at $16,000.
> Number 10 is a big beef company, Sam Kane Beef
> Processors and tied for number 13 is the American Meat
> Institute and the Texas Southwestern Cattle Raisers.
>
> http://www.opensecrets.org/politicians/index.asp
>
>
> NOT about human health. it's about commodities and
> futures and who can bribe or donate the most to
> whom$$$TSS
>
>
> JUST look how the feed compounders handled things in
> the UK;
>
>
> >DATA Charmaine's HD:BSE - AUGUST 95-fill in bse
> position paper spec<
>
> FROM THE DIRECTOR GENERAL
>
> 24 August, 1995
>
> STRICTLY PRIVATE AND CONFIDENTIAL
>
>
> Dear .salutation
>
> UKASTA POLICY ON BSE
>
> At the President's suggestion in the light of recent
> events, I have
> reviewed the history of our policy on BSE so as to
> ensure that it fully
> reflects the needs of our supporters In the feed
> Industry.
>
> The paper enclosed with this letter is the result. For
> obvious reasons,
> this is being circulated only to an extremely small
> circle within
> UKASTA - basically, the National Executive Council.
>
> If you have any comments on the policy, or the paper,
> I should be glad
> to receive them under Private & Confidential cover.
>
> Yours sincerely,
>
> J.W. REED
>
> JWR/cg
>
> copied to SMT members - IJD; JN; JAS; REW
>
>
> 95/8.24/2.1
>
>
> STRICTLY PRIVATE AND CONFIDENTIAL
>
> UKASTA INTERNAL POSITION STATEMENT
> BOVINE SPONGIFORM ENCEPHALOPATHY
>
> POLICY AIMS
>
> 1. These have been consistent, although unstated
> except In FEC discussions, since at least 1989:-
>
> . To minimise the risk of farmers' claims for
> compensation from feed
> compounders.
>
> . To minimise the potential damage to compound feed
> markets
> through adverse publicity.
>
> . To maximise freedom of action for feed compounders.
> notably by
> maintaining the availability of meat and bone meal as
> a raw
> material in animal feeds, and ensuring time is
> available to make
> any changes which may be required.
>
>
> STRATEGY ADOPTED/SUCCESS ACHIEVED
>
> 2. Strategy has depended upon the situation at a
> particular time.
> UKASTA has sought to anticipate criticism from other
> industry sectors
> and action by Government/Brussels as the epidemic has
> developed
> and knowledge of the disease increased. Through dose
> liaison with
> MAFF. we have to date avoided public statements
> seriously damaging
> to the feed Industry and the adoption of policies
> likely to lead to such
> damage.
>
> 3. Successful examples of this strategy include:
>
> . "Voluntary Ban" on SBO's In all MBM purchase
> contracts from
> November 1989. matching the Government ban on SBO'S in
> human food but anticipating the statutory ban on SBO's
> in feed
> which came in only from September 1990;
>
> . Pressing Government for full compensation to
> farmers, which was
> finally conceded in February 1990;
>
> . evidence (not Just on BSE) to the Lamming Committee
> in 1991/92
> resulted in their recommending tighter controls over
> home
> mixers/integrated operations, and over the processing
> of fallen
> animals. Government eventually tightened the fallen
> animals
> legislation in December 1992. Other Lamming
> recommendations
> could yet be useful to us.
>
> continued.....
>
> 95/8.24/2.2
>
> 2
>
> . UKASTA pressure dissuaded MAFF from publicly linking
> voluntary
> ELISA tests of feed on farms with BAB's to (possibly
> compulsory)
> tests at compounders' premises in June/July 1994:
>
> . in August 1995. while tightening the SBO Order and
> responding
> to the EU Decision requiring introduction of a testing
> programme.
> MAFF has accepted UKASTA proposals for the
> presentation of the
> changes to a wider audience, including farmers, and
> accepted our
> help in preparing for an EU Commission visit to
> inspect
> procedures and controls.
>
>
> THE FUTURE
>
> 4. BSE has for more than seven years posed the
> greatest single potential
> threat to feed compounders' profitability. Although
> the epidemic is in
> sharp decline (275 cases per week compared to 1000 at
> the peak).
> MAFF remains under pressure in Brussels and is not
> skilled at
> handling potentially explosive issues.
>
> 5. Tests may show that ruminant feeds have been sold
> which contain
> illegal traces of ruminant protein. More likely, a few
> positive test
> results will turn up but proof that a particular feed
> mill knowingly
> supplied it to a particular farm will be difficult if
> not impossible.
>
> 6. The threat remains real and it will be some years
> before feed
> compounders are free of it. The longer we can avoid
> any direct
> linkage between feed milling practices and actual BSE
> cases, the more
> likely it is that serious damage can be avoided. In
> issue management
> terms, the aims and the strategy remain valid, but
> must be kept
> under review in the light of further events.
>
> JWR/cg/23.8.95
>
> 95/8.24/2.3
>
>
> http://www.bseinquiry.gov.uk/files/yb/1995/08/24002001.pdf
>
>
>
> 95\08.01\7.1-7.2 01/08/95 T E D Eddy PS/Mrs Browning
> Confidential - BSE : SBOs
>
> snip...
>
> 4. Subject to furhter clarification on the problem at
> the two plants we can no longer maintain publicly that
> our visits to slaughterhouses have shown no
> implications for human health. I would advise against
> an immediate response to Farming News. We need to
> investigate the two reports in greater detail to
> clarify whether the circumstances were such as to
> suggest there was a genuine risk to human health.
>
> TED EDDY
>
> http://www.bseinquiry.gov.uk/files/yb/1995/08/01007001.pdf
>
> INDUSTRY NEWS
>
> 6. Although it normally occurs in elderly people, CJD
> has been found in young people - in the US, for
> example, where BSE does not exist...
>
> http://www.bseinquiry.gov.uk/files/yb/1995/08/10004001.pdf
>
>
> THEY EACH protect there own, to hell with human
> health$$$TSS
>
>
> Although many observers anticipated amendments and
> heated debate on the controversial country-of-origin
> labeling law, there was little discussion. The bill
> includes a provision offered by Subcommittee Chairman
> Henry Bonilla (R-Texas) that would stop USDA from
> implementing the country-of-origin labeling law for
> meat and meat products.
>
>
> http://www.vermontagriculture.com/Agriview%20Online/Agriview070103/agriviewonline1.htm
>
>
> House Passes Amendment Blocking COOL
>
>
> http://www.porknet.com/page.cfm?PageID=&PassLevel=&menu=&AppContinue=Articles%2FArticle&ID=99981&Newsletter=true
>
>
>
> The House Agriculture Appropriations bill was passed
> in July," Katy Ziegler, of the National Farmers Union,
> said. "It contains language to prohibit (the) USDA
> from spending any more funds to implement COOL for
> meat products for one year. This rider was included by
> Rep. (Henry) Bonilla (R-Texas) via the request of
> meatpackers in Texas who hate COOL."
>
>
> http://64.233.187.104/search?q=cache:ZzvXcUoDyGIJ:www.the-land.com/column.php%3Fstoryid%3D66+COOL+Bonilla-R-Texas+++PACKERS&hl=en
>
>
>
> Rep. Henry Bonilla, R-Texas: "This country-of-origin
> labeling provision that was put in the Farm Bill last
> year is controversial and costly."
>
>
> http://www.iptv.org/mtom/archivedfeature.cfm?Fid=220
>
>
>
> News Release
> USDA seeks comments on animal-ID plan, May 10, 2005
> Last week Agriculture Secretary Mike Johanns unveiled
> a "thinking paper" and timeline on the National Animal
> Identification System and asked for feedback on the
> draft plan from industry stakeholders. The timeline
> calls for operational premises registration in all
> states by July 2005. Beginning in April 2007, the plan
> calls for the USDA to begin issuing "alerts" prior to
> premises registration and animal identification
> becoming mandatory in January 2008. The timeline calls
> for reporting of defined animal movements to become
> mandatory in January 2009. The agency will accept
> comments on the plan until June 6.
>
>
> http://www.ezidavid.com/News%20Release%20USAHA%2010-02.htm
>
>
>
> Gerald Wells: Report of the Visit to USA, April-May
> 1989
>
> snip...
>
> The general opinion of those present was that BSE, as
> an
> overt disease phenomenon, _could exist in the USA, but
> if it did,
> it was very rare. The need for improved and specific
> surveillance
> methods to detect it as recognised...
>
> snip...
>
> It is clear that USDA have little information and _no_
> regulatory
> responsibility for rendering plants in the US...
>
> snip...
>
> 3. Prof. A. Robertson gave a brief account of BSE. The
> US approach
> was to accord it a _very low profile indeed_. Dr. A
> Thiermann showed
> the picture in the ''Independent'' with cattle being
> incinerated and thought
> this was a fanatical incident to be _avoided_ in the
> US _at all costs_...
>
> snip...
>
> http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf
>
> To be published in the Proceedings of the
> Fourth International Scientific Congress in
> Fur Animal Production. Toronto, Canada,
> August 21-28, 1988
>
> Evidence That Transmissible Mink Encephalopathy
> Results from Feeding Infected Cattle
>
> R.F. Marsh* and G.R. Hartsough
>
> .Department of Veterinary Science, University of
> Wisconsin-Madison, Madison,
> Wisconsin 53706; and ^Emba/Creat Lakes Ranch Service,
> Thiensville, Wisconsin 53092
>
> ABSTRACT
> Epidemiologic investigation of a new incidence of
> transmissible mink encephalopathy (TME) in
> Stetsonville, Wisconsin
> suggests that the disease may have resulted from
> feeding infected
> cattle to mink. This observation is supported by the
> transmission of
> a TME-like disease to experimentally inoculated
> cattle, and by the
> recent report of a new bovine spongiform
> encephalopathy in
> England.
>
> INTRODUCTION
>
> Transmissible mink encephalopathy (TME) was first
> reported in 1965 by Hartsough
> and Burger who demonstrated that the disease was
> transmissible with a long incubation
> period, and that affected mink had a spongiform
> encephalopathy similar to that found in
> scrapie-affecied sheep (Hartsough and Burger, 1965;
> Burger and Hartsough, 1965).
> Because of the similarity between TME and scrapie, and
> the subsequent finding that the
> two transmissible agents were indistinguishable (Marsh
> and Hanson, 1969), it was
> concluded that TME most likely resulted from feeding
> mink scrapie-infecied sheep.
> The experimental transmission of sheep scrapie to mink
> (Hanson et al., 1971)
> confirmed the close association of TME and scrapie,
> but at the same time provided
> evidence that they may be different. Epidemiologic
> studies on previous incidences of
> TME indicated that the incubation periods in field
> cases were between six months and
> one year in length (Harxsough and Burger, 1965).
> Experimentally, scrapie could not be
> transmitted to mink in less than one year.
> To investigate the possibility that TME may be caused
> by a (particular strain of
> scrapie which might be highly pathogenic for mink, 21
> different strains of the scrapie
> agent, including their sheep or goat sources, were
> inoculated into a total of 61 mink.
> Only one mink developed a progressive neurologic
> disease after an incubation period of
> 22 mon..s (Marsh and Hanson, 1979). These results
> indicated that TME was either caused
> by a strain of sheep scrapie not yet tested, or was
> due to exposure to a scrapie-like agent
> from an unidentified source.
>
> OBSERVATIONS AND RESULTS
>
> A New Incidence of TME. In April of 1985, a mink
> rancher in Stetsonville, Wisconsin
> reported that many of his mink were "acting funny",
> and some had died. At this time, we
> visited the farm and found that approximately 10% of
> all adult mink were showing
> typical signs of TME: insidious onset characterized by
> subtle behavioral changes, loss of
> normal habits of cleanliness, deposition of droppings
> throughout the pen rather than in a
> single area, hyperexcitability, difficulty in chewing
> and swallowing, and tails arched over
> their _backs like squirrels. These signs were followed
> by progressive deterioration of
> neurologic function beginning with locomoior
> incoordination, long periods of somnolence
> in which the affected mink would stand motionless with
> its head in the corner of the
> cage, complete debilitation, and death. Over the next
> 8-10 weeks, approximately 40% of
> all the adult mink on the farm died from TME.
> Since previous incidences of TME were associated with
> common or shared feeding
> practices, we obtained a careful history of feed
> ingredients used over the past 12-18
> months. The rancher was a "dead stock" feeder using
> mostly (>95%) downer or dead dairy
> cattle and a few horses. Sheep had never been fed.
>
> Experimental Transmission. The clinical diagnosis of
> TME was confirmed by
> histopaihologic examination and by experimental
> transmission to mink after incubation
> periods of four months. To investigate the possible
> involvement of cattle in this disease
> cycle, two six-week old castrated Holstein bull calves
> were inoculated intracerebrally
> with a brain suspension from affected mink. Each
> developed a fatal spongiform
> encephalopathy after incubation periods of 18 and 19
> months.
>
> DISCUSSION
> These findings suggest that TME may result from
> feeding mink infected cattle and
> we have alerted bovine practitioners that there may
> exist an as yet unrecognized
> scrapie-like disease of cattle in the United States
> (Marsh and Hartsough, 1986). A new
> bovine spongiform encephalopathy has recently been
> reported in England (Wells et al.,
> 1987), and investigators are presently studying its
> transmissibility and possible
> relationship to scrapie. Because this new bovine
> disease in England is characterized by
> behavioral changes, hyperexcitability, and
> agressiveness, it is very likely it would be
> confused with rabies in the United Stales and not be
> diagnosed. Presently, brains from
> cattle in the United States which are suspected of
> rabies infection are only tested with
> anti-rabies virus antibody and are not examined
> histopathologically for lesions of
> spongiform encephalopathy.
> We are presently pursuing additional studies to
> further examine the possible
> involvement of cattle in the epidemiology of TME. One
> of these is the backpassage of
> our experimental bovine encephalopathy to mink.
> Because (here are as yet no agent-
> specific proteins or nucleic acids identified for
> these transmissible neuropathogens, one
> means of distinguishing them is by animal passage and
> selection of the biotype which
> grows best in a particular host. This procedure has
> been used to separate hamster-
> adapted and mink-udapted TME agents (Marsh and Hanson,
> 1979). The intracerebral
> backpassage of the experimental bovine agent resulted
> in incubations of only four months
> indicating no de-adaptation of the Stetsonville agent
> for mink after bovine passage.
> Mink fed infected bovine brain remain normal after six
> months. It will be essential to
> demonstrate oral transmission fiom bovine to mink it
> this proposed epidemiologic
> association is to be confirmed.
>
> ACKNOWLEDGEMENTS
> These studies were supported by the College of
> Agricultural and Life Sciences,
> University of Wisconsin-Madison and by a grant
> (85-CRCR-1-1812) from the United
> States Department of Agriculture. The authors also
> wish to acknowledge the help and
> encouragement of Robert Hanson who died during the
> course of these investigations.
>
> REFERENCES
> Burger, D. and Hartsough, G.R. 1965. Encephalopathy of
> mink. II. Experimental and
> natural transmission. J. Infec. Dis. 115:393-399.
> Hanson, R.P., Eckroade, R.3., Marsh, R.F., ZuRhein,
> C.M., Kanitz, C.L. and Gustatson,
> D.P. 1971. Susceptibility of mink to sheep scrapie.
> Science 172:859-861.
> Hansough, G.R. and Burger, D. 1965. Encephalopathy of
> mink. I. Epizoociologic and
> clinical observations. 3. Infec. Dis. 115:387-392.
> Marsh, R.F. and Hanson, R.P. 1969. Physical and
> chemical properties of the
> transmissible mink encephalopathy agent. 3. ViroL
> 3:176-180.
> Marsh, R.F. and Hanson, R.P. 1979. On the origin of
> transmissible mink
> encephalopathy. In Hadlow, W.J. and Prusiner, S.P.
> (eds.) Slow transmissible
> diseases of the nervous system. Vol. 1, Academic
> Press, New York, pp 451-460.
> Marsh, R.F. and Hartsough, G.R. 1986. Is there a
> scrapie-like disease in cattle?
> Proceedings of the Seventh Annual Western Conference
> for Food Animal Veterinary
> Medicine. University of Arizona, pp 20.
> Wells, G.A.H., Scott, A.C., Johnson, C.T., Cunning,
> R.F., Hancock, R.D., Jeffrey, M.,
> Dawson, M. and Bradley, R. 1987. A novel progressive
> spongiform encephalopathy
> in cattle. Vet. Rec. 121:419-420.
>
> MARSH
>
> http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf
>
>
> WE need to vote these BOUGHT AND PAID FOR, CORPORATE
> OWNED @holes out of office,
> NO MATTER WHAT PARTY THEY ARE WITH. IT should be about
> the people, for the people, but
> it is just the opposite, it's about the industry and
> for the industry, to hell with human health...
>
>
> 1: J Infect Dis 1980 Aug;142(2):205-8
>
>
>
> Oral transmission of kuru, Creutzfeldt-Jakob disease,
> and scrapie to nonhuman primates.
>
> Gibbs CJ Jr, Amyx HL, Bacote A, Masters CL, Gajdusek
> DC.
>
> Kuru and Creutzfeldt-Jakob disease of humans and
> scrapie disease of sheep and goats were transmitted to
> squirrel monkeys (Saimiri sciureus) that were exposed
> to the infectious agents only by their nonforced
> consumption of known infectious tissues. The
> asymptomatic incubation period in the one monkey
> exposed to the virus of kuru was 36 months; that in
> the two monkeys exposed to the virus of
> Creutzfeldt-Jakob disease was 23 and 27 months,
> respectively; and that in the two monkeys exposed to
> the virus of scrapie was 25 and 32 months,
> respectively. Careful physical examination of the
> buccal cavities of all of the monkeys failed to reveal
> signs or oral lesions. One additional monkey similarly
> exposed to kuru has remained asymptomatic during the
> 39 months that it has been under observation.
>
> PMID: 6997404
> http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=6997404&dopt=Abstract
>
>
>
>
> 1: J Neurol Neurosurg Psychiatry 1994 Jun;57(6):757-8
>
>
>
> Transmission of Creutzfeldt-Jakob disease to a
> chimpanzee by electrodes contaminated during
> neurosurgery.
>
> Gibbs CJ Jr, Asher DM, Kobrine A, Amyx HL, Sulima MP,
> Gajdusek DC.
>
> Laboratory of Central Nervous System Studies, National
> Institute of Neurological Disorders and Stroke,
> National Institutes of Health, Bethesda, MD 20892.
>
> Stereotactic multicontact electrodes used to probe the
> cerebral cortex of a middle aged woman with
> progressive dementia were previously implicated in the
> accidental transmission of Creutzfeldt-Jakob disease
> (CJD) to two younger patients. The diagnoses of CJD
> have been confirmed for all three cases. More than two
> years after their last use in humans, after three
> cleanings and repeated sterilisation in ethanol and
> formaldehyde vapour, the electrodes were implanted in
> the cortex of a chimpanzee. Eighteen months later the
> animal became ill with CJD. This finding serves to
> re-emphasise the potential danger posed by reuse of
> instruments contaminated with the agents of spongiform
> encephalopathies, even after scrupulous attempts to
> clean them.
>
> PMID: 8006664 [PubMed - indexed for MEDLINE]
> http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8006664&dopt=Abstract
>
>
> SCRAPIE USA MONTHLY REPORT 2005
>
> AS of March 31, 2005, there were 70 scrapie infected
> source flocks (Figure 3). There were 11 new infected
> and source flocks reported in March (Figure 4) with a
> total of 51 flocks reported for FY 2005 (Figure 5).
> The total infected and source flocks that have been
> released in FY 2005 are 39 (Figure 6), with 1 flock
> released in March. The ratio of infected and source
> flocks released to newly infected and source flocks
> for FY 2005 = 0.76 : 1. IN addition, as of March 31,
> 2005, 225 scrapie cases have been confirmed and
> reported by the National Veterinary Services
> Laboratories (NVSL), of which 53 were RSSS cases
> (Figure 7). This includes 57 newly confirmed cases in
> March 2005 (Figure 8). Fourteen cases of scrapie in
> goats have been reported since 1990 (Figure 9). The
> last goat cases was reported in January 2005. New
> infected flocks, source flocks, and flocks released or
> put on clean-up plans for FY 2005 are depicted in
> Figure 10. ...
>
> FULL TEXT ;
>
> http://www.aphis.usda.gov/vs/nahps/scrapie/monthly_report/monthly-report.html
>
>
>
> USDA CWD PROGRAM
>
> http://www.aphis.usda.gov/vs/nahps/cwd/
>
> USDA CWD MAP (slow to update)
>
> http://www.aphis.usda.gov/vs/nahps/cwd/cwd-distribution.html
>
>
> CWD NEW YORK
>
> http://www.agmkt.state.ny.us/AI/cwd.html
>
> http://www.nyhealth.gov/nysdoh/zoonoses/cwd.htm
>
>
>
> Gerald Wells: Report of the Visit to USA, April-May
> 1989
>
> snip...
>
> The general opinion of those present was that BSE, as
> an
> overt disease phenomenon, _could exist in the USA, but
> if it did,
> it was very rare. The need for improved and specific
> surveillance
> methods to detect it as recognised...
>
> snip...
>
> It is clear that USDA have little information and _no_
> regulatory
> responsibility for rendering plants in the US...
>
> snip...
>
> 3. Prof. A. Robertson gave a brief account of BSE. The
> US approach
> was to accord it a _very low profile indeed_. Dr. A
> Thiermann showed
> the picture in the ''Independent'' with cattle being
> incinerated and thought
> this was a fanatical incident to be _avoided_ in the
> US _at all costs_...
>
> snip...
>
> http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf
>
> To be published in the Proceedings of the
> Fourth International Scientific Congress in
> Fur Animal Production. Toronto, Canada,
> August 21-28, 1988
>
> Evidence That Transmissible Mink Encephalopathy
> Results from Feeding Infected Cattle
>
> R.F. Marsh* and G.R. Hartsough
>
> .Department of Veterinary Science, University of
> Wisconsin-Madison, Madison,
> Wisconsin 53706; and ^Emba/Creat Lakes Ranch Service,
> Thiensville, Wisconsin 53092
>
> ABSTRACT
> Epidemiologic investigation of a new incidence of
> transmissible mink encephalopathy (TME) in
> Stetsonville, Wisconsin
> suggests that the disease may have resulted from
> feeding infected
> cattle to mink. This observation is supported by the
> transmission of
> a TME-like disease to experimentally inoculated
> cattle, and by the
> recent report of a new bovine spongiform
> encephalopathy in
> England.
>
> INTRODUCTION
>
> Transmissible mink encephalopathy (TME) was first
> reported in 1965 by Hartsough
> and Burger who demonstrated that the disease was
> transmissible with a long incubation
> period, and that affected mink had a spongiform
> encephalopathy similar to that found in
> scrapie-affecied sheep (Hartsough and Burger, 1965;
> Burger and Hartsough, 1965).
> Because of the similarity between TME and scrapie, and
> the subsequent finding that the
> two transmissible agents were indistinguishable (Marsh
> and Hanson, 1969), it was
> concluded that TME most likely resulted from feeding
> mink scrapie-infecied sheep.
> The experimental transmission of sheep scrapie to mink
> (Hanson et al., 1971)
> confirmed the close association of TME and scrapie,
> but at the same time provided
> evidence that they may be different. Epidemiologic
> studies on previous incidences of
> TME indicated that the incubation periods in field
> cases were between six months and
> one year in length (Harxsough and Burger, 1965).
> Experimentally, scrapie could not be
> transmitted to mink in less than one year.
> To investigate the possibility that TME may be caused
> by a (particular strain of
> scrapie which might be highly pathogenic for mink, 21
> different strains of the scrapie
> agent, including their sheep or goat sources, were
> inoculated into a total of 61 mink.
> Only one mink developed a progressive neurologic
> disease after an incubation period of
> 22 mon..s (Marsh and Hanson, 1979). These results
> indicated that TME was either caused
> by a strain of sheep scrapie not yet tested, or was
> due to exposure to a scrapie-like agent
> from an unidentified source.
>
> OBSERVATIONS AND RESULTS
>
> A New Incidence of TME. In April of 1985, a mink
> rancher in Stetsonville, Wisconsin
> reported that many of his mink were "acting funny",
> and some had died. At this time, we
> visited the farm and found that approximately 10% of
> all adult mink were showing
> typical signs of TME: insidious onset characterized by
> subtle behavioral changes, loss of
> normal habits of cleanliness, deposition of droppings
> throughout the pen rather than in a
> single area, hyperexcitability, difficulty in chewing
> and swallowing, and tails arched over
> their _backs like squirrels. These signs were followed
> by progressive deterioration of
> neurologic function beginning with locomoior
> incoordination, long periods of somnolence
> in which the affected mink would stand motionless with
> its head in the corner of the
> cage, complete debilitation, and death. Over the next
> 8-10 weeks, approximately 40% of
> all the adult mink on the farm died from TME.
> Since previous incidences of TME were associated with
> common or shared feeding
> practices, we obtained a careful history of feed
> ingredients used over the past 12-18
> months. The rancher was a "dead stock" feeder using
> mostly (>95%) downer or dead dairy
> cattle and a few horses. Sheep had never been fed.
>
> Experimental Transmission. The clinical diagnosis of
> TME was confirmed by
> histopaihologic examination and by experimental
> transmission to mink after incubation
> periods of four months. To investigate the possible
> involvement of cattle in this disease
> cycle, two six-week old castrated Holstein bull calves
> were inoculated intracerebrally
> with a brain suspension from affected mink. Each
> developed a fatal spongiform
> encephalopathy after incubation periods of 18 and 19
> months.
>
> DISCUSSION
> These findings suggest that TME may result from
> feeding mink infected cattle and
> we have alerted bovine practitioners that there may
> exist an as yet unrecognized
> scrapie-like disease of cattle in the United States
> (Marsh and Hartsough, 1986). A new
> bovine spongiform encephalopathy has recently been
> reported in England (Wells et al.,
> 1987), and investigators are presently studying its
> transmissibility and possible
> relationship to scrapie. Because this new bovine
> disease in England is characterized by
> behavioral changes, hyperexcitability, and
> agressiveness, it is very likely it would be
> confused with rabies in the United Stales and not be
> diagnosed. Presently, brains from
> cattle in the United States which are suspected of
> rabies infection are only tested with
> anti-rabies virus antibody and are not examined
> histopathologically for lesions of
> spongiform encephalopathy.
> We are presently pursuing additional studies to
> further examine the possible
> involvement of cattle in the epidemiology of TME. One
> of these is the backpassage of
> our experimental bovine encephalopathy to mink.
> Because (here are as yet no agent-
> specific proteins or nucleic acids identified for
> these transmissible neuropathogens, one
> means of distinguishing them is by animal passage and
> selection of the biotype which
> grows best in a particular host. This procedure has
> been used to separate hamster-
> adapted and mink-udapted TME agents (Marsh and Hanson,
> 1979). The intracerebral
> backpassage of the experimental bovine agent resulted
> in incubations of only four months
> indicating no de-adaptation of the Stetsonville agent
> for mink after bovine passage.
> Mink fed infected bovine brain remain normal after six
> months. It will be essential to
> demonstrate oral transmission fiom bovine to mink it
> this proposed epidemiologic
> association is to be confirmed.
>
> ACKNOWLEDGEMENTS
> These studies were supported by the College of
> Agricultural and Life Sciences,
> University of Wisconsin-Madison and by a grant
> (85-CRCR-1-1812) from the United
> States Department of Agriculture. The authors also
> wish to acknowledge the help and
> encouragement of Robert Hanson who died during the
> course of these investigations.
>
> REFERENCES
> Burger, D. and Hartsough, G.R. 1965. Encephalopathy of
> mink. II. Experimental and
> natural transmission. J. Infec. Dis. 115:393-399.
> Hanson, R.P., Eckroade, R.3., Marsh, R.F., ZuRhein,
> C.M., Kanitz, C.L. and Gustatson,
> D.P. 1971. Susceptibility of mink to sheep scrapie.
> Science 172:859-861.
> Hansough, G.R. and Burger, D. 1965. Encephalopathy of
> mink. I. Epizoociologic and
> clinical observations. 3. Infec. Dis. 115:387-392.
> Marsh, R.F. and Hanson, R.P. 1969. Physical and
> chemical properties of the
> transmissible mink encephalopathy agent. 3. ViroL
> 3:176-180.
> Marsh, R.F. and Hanson, R.P. 1979. On the origin of
> transmissible mink
> encephalopathy. In Hadlow, W.J. and Prusiner, S.P.
> (eds.) Slow transmissible
> diseases of the nervous system. Vol. 1, Academic
> Press, New York, pp 451-460.
> Marsh, R.F. and Hartsough, G.R. 1986. Is there a
> scrapie-like disease in cattle?
> Proceedings of the Seventh Annual Western Conference
> for Food Animal Veterinary
> Medicine. University of Arizona, pp 20.
> Wells, G.A.H., Scott, A.C., Johnson, C.T., Cunning,
> R.F., Hancock, R.D., Jeffrey, M.,
> Dawson, M. and Bradley, R. 1987. A novel progressive
> spongiform encephalopathy
> in cattle. Vet. Rec. 121:419-420.
>
> MARSH
>
> http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf
>
>
> TSS
>
>
>
September 13,2004
USDA, FSTS
Docket Clerk
300 12* Street, SW
Room 102, Cotton Annex
Washington, DC 20250
04-021ANPR
04-021ANPR-70
Richard L. Crawford
Re: Docket No: 04-02 1 ANPR Federal Measures to Mitigate BSE Risks: Considerations
for Further Action
Dear Sir or Madame:
On behalf of McDonald’s Corporation, which operates more than 13,000 restaurants in
the United States, we appreciate the opportunity to submit comments to this very
important Advance Notice of Proposed Rulemaking (ANPRM). 69 Fed. Reg. 42288 (July
14,2004).
In previous comments submitted to FSIS regarding the removal of SRI&, McDonalds
fully supported this rule and its immediate implementation. The removal of SRMs from
human food is the primary firewall to protect the US consumer from being exposed to the
BSE agent. While we applaud the requirement for SRM removal, we feel that it is
equally important for FSIS to insure that each slaughterplant which processes cattle have
systems in place which prevent cross contamination between edible tissue and SRMs.
This should include but not be limited to the use of separate equipment, such as knives,
blades, etc. where appropriate. In addition, it is also important that appropriate and
effective disinfection procedures for equipment used to handle SRMs be developed and
approved for use.
It is our opinion that requiring SRM removal without a procedure to prevent cross
contamination is inadequate as a protective public health measure. The TSE agents
@ions) are sticky and highly resistant to disinfection. If SRMs such as brain and spinal
cord are allowed to contact equipment and other surfaces such as deboning tables which
then are used to handle and process edible tissue this could allow contamination and
negates the intention of the ban. This is true not only in plants slaughtering fed cattle
both under and over 30 months but also in plants slaughtering predominately older cattle.
It is important that measure be taken to prevent cross contamination between carcasses
and SRms in the cull plants. McDonalds requires their suppliers to prevent cross
contamination and audits against certain measurable standards such as requiring spinal
cord to bc removed on the kill floor. We would be willing to share these standards with
FSIS as an example.
FSIS Docket No. 04-02 1 ANPR
dooqhl- =w c1qo -
McDonalds again recommends that dura (the covering around the brain and spinal cord)
be added to the list of SRMs. While skull and vertebral column are included as SRMs,
dura is not. If dura is not removed prior to processing on the fabrication floor, it may
come loose and be incorporated into ground product. Bovine dura was never tested for
infectivity. It was assumed that due to direct contact with spinal cord, it may serve as a
vehicle to transmit disease. In addition, human dura has been the source of human to
human transmission of Creutzfeldt-Jakob Disease (CJD). (personal communication - Dr.
Danny Matthews, UK, VLA) Our ISAC committee recommended that McDonalds add
the removal of dura as a specification in the production of our product.
McDonalds urges the USDA to make the appropriate adjustments in the SRM ban if new
scientific findings and/or the results of the increased surveillance warrant a change.
In regards to imported meat products from other countries, McDonalds suggests that no
SRM exemption be made for countries based on BSE risk. The long incubation period
and limited surveillance in many countries can limit the ability to accurately determine
risk. Also, the risk level of a country could potentially change over night if the trading
patterns of a country changed. It seems logistically impossible to maintain a system
which could continually monitor the world’s trading patterns. In addition, science has
not provided all of the answers in regards to the transmission of BSE. Requiring SRMs
to be removed from imported products for human food is prudent. If the US would wait
until disease is confirmed the exposure would already have occurred.
Thank you for the opportunity to comment on these very important issues.
Richard L. Crawford
Corporat,e Vice President, Government Relations
McDonalds Corporation
1 Kroc Drive
Oak Brook, Illinois 60523
FSIS Docket No. 04-021ANPR
http://www.fda.gov/ohrms/dockets/dailys/04/sep04/092104/04n-0264-c00140-vol22.pdf
2004N-0264 Federal Measures to Mitigate BSE Risks: Considerations for Further Action
C 136 National Cattlemen's Beef Assn (NCBA) Vol #: 22
C 137 Public Citizen Vol #: 22
C 138 Center for Science in the Public Interest (CSPI) Vol #: 22
C 139 Humane Society of the United States (HSUS) Vol #: 22
C 140 McDonald's Corporation Vol #: 22
C 141 North American Natural Casing Assn (NANCA) Vol #: 22
C 142 National Renderers Assn Vol #: 22
C 143 G.A.O.B., Inc. Vol #: 22
C 144 Gelatin Manufacturers of Europe (GME) Vol #: 22
C 145 IBM Business Consulting Services Vol #: 22
C 146 L. Fischer Vol #: 22
C 147 C. Rothenfluch Vol #: 22
C 148 C. Addonizio Vol #: 22
C 149 M. Clifton Vol #: 22
http://www.fda.gov/ohrms/dockets/dailys/04/sep04/092104/092104.htm#04N0264
Dockets Entered on December 22, 2005
2005D-0330, Guidance for Industry and FDA Review Staff on Collection of Platelets
by Automated ... EC 203, McDonald's Restaurants Corporation, Vol #:, 34 ...
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122205/122205.htm
03-025IF 03-025IF-631 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-631 Linda A. Detwiler Page 2. Page 3. Page 4.
Page 5. Page 6. Page 7. Page 8. Page 9. Page 10. Page 11. Page 12.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf - Text Version
03-025IF 03-025IF-634 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-634 Linda A. Detwiler Page 2.
Page 3. Page 4. Page 5. Page 6. Page 7. Page 8.
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[ More results from www.fsis.usda.gov/OPPDE/Comments/03-025IF/ ]
Page 1 of 17 9/13/2005 [PDF]
... 2005 6:17 PM To:
[email protected] Subject: [Docket No. 03-025IFA]
FSIS Prohibition of the Use of Specified Risk Materials for Human Food ...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf - Text Version
03-025IFA 03-025IFA-6 Jason Frost [PDF]
... Zealand Embassy COMMENTS ON FEDERAL REGISTER 9 CFR Parts 309 et al [Docket No. 03-
025IF] Prohibition of the Use of Specified Risk Materials for Human Food and ...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-6.pdf - Text Version
http://www.fsis.usda.gov/Search/Search_Results/Index.asp?q=03-025IF&mode=simple&num=10&as_occt=any&restrict=FSIS_DOCKET_COMMENTS
In its opinion of 7-8 December 2000 (EC 2000), the SSC ... [PDF]
Page 1. Linda A. Detwiler, DVM 225 Hwy 35 Red Bank, New Jersey 07701 Phone: 732-741-2290
Cell: 732-580-9391 Fax: 732-741-7751 June 22, 2005 FSIS Docket Clerk US ...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-589.pdf
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-589.pdf
Page 1 of 17 9/13/2005 [PDF]
... Page 1 of 17 From: Terry S. Singeltary Sr. [
[email protected]] Sent: Thursday,
September 08, 2005 6:17 PM To:
[email protected] Subject ...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
03-025IF 03-025IF-618 Richard L. Crawford [PDF]
Page 1. 03-025IF 03-025IF-618 Richard L. Crawford
Page 2. Page 3. Page 4.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-618.pdf -
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-618.pdf
03-038IF 03-038IF-15 Richard L. Crawford [PDF]
Page 1. 03-038IF 03-038IF-15 Richard L. Crawford
Page 2. Page 3. Page 4.
http://www.fsis.usda.gov/OPPDE/Comments/03-038IF/03-038IF-15.pdf -
http://www.fsis.usda.gov/OPPDE/Comments/03-038IF/03-038IF-15.pdf
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf
9 December 2005
Division of Dockets Management (RFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)
Substances Prohibited From Use in Animal Food and Feed
Dear Sir or Madame:
Serologicals Corporation is a global provider of biological products to life science companies.
The Company’s products are essential for the research, development and manufacturing of
biologically based diagnostic, pharmaceutical and biological products. customers include
many of the leading research institutions, diagnostic and pharmaceutical companies throughout
the world. The Company’s products and technologies are used in a wide variety of applications
within the areas of neurobiology, cell signaling, oncology, angiogenesis, apoptosis,
developmental biology, cellular physiology, hematology, immunology, cardiology, infectious
diseases and molecular biology.
A number of our products are derived from bovine blood or other bovine tissues sourced in the
United States, hence the overall health of the national herd is extremely important to our
company as well as to our customers and their patients. Some of our bovine based products are
used in the manufacture of vaccines and drugs for humans, hence it is critical that all measures
are taken to assure these are safe and free from disease especially Bovine Spongiform
Encephalopathy (BSE). The most effective way to insure this is to create a system which
processes cattle that are BSE free. As a company there are a number of precautions that we can
take by our strict specifications but many of the needed precautions require the force of federal
regulation, hence we appreciate the opportunity to submit comments to this very important
proposed rule.
After the identification of bovine spongiform encephalopathy (BSE) in indigenous North
American cattle, the U.S. Department of Agriculture (USDA) responded rapidly to implement
measures to protect public health in regard to food. Our company recognizes and supports the
importance of the current feed ban which went into effect in August 1997. However, given what
is known about the epidemiology and characteristically long incubation period of BSE, we urge
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Division of Dockets Management (HFA-305)
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9 December 2005
the FDA to act without further delay and implement additional measures which will reduce the
risk of BSE recycling in the US cattle herd.
We feel that for the FDA to provide a more comprehensive and protective feed ban, specified
risk materials (SRMs) and deadstock must be removed from all animal feed and that legal
exemptions which allow ruminant protein to be fed back to ruminants (with the exception of
milk) should be discontinued.
SRMs, as defined by the USDA, are tissues which, in a BSE infected animal, are known to either
harbor BSE infectivity or to be closely associated with infectivity. If SRMs are not removed,
they may introduce BSE infectivity and continue to provide a source of animal feed
contamination. Rendering will reduce infectivity but it will not totally eliminate it. This is
significant as research in the United Kingdom has shown that a calf may be infected with BSE
by the ingestion of as little as .OOl gram of untreated brain.
The current proposed rule falls short of this and would still leave a potential source of infectivity
in the system. In fact by the FDA’s own statement the exempted tissues which are known to
have infectivity (such as distal ileum, DRGs, etc) would cumulatively amount to 10% of the
infectivity in an infected animal, This proposed rule would still allow for the possibility that
cattle could be exposed to BSE through:
1. Feeding of materials currently subject to legal exemptions from the ban (e.g., poultry
litter, plate waste)
2. Cross feeding (the feeding of non-ruminant rations to ruminants) on farms; and
3. Cross contamination of ruminant and non-ruminant feed
We are most concerned that the FDA has chosen to include a provision which would allow
tissues from deadstock into the feed chain. We do not support the provision to allow the removal
of brain and spinal cord from down and deadstock over 30 months of age for several reasons.
These are the animals with the highest level of infectivity in tissues which include more than
brain and spinal cord. We do not feel that there can be adequate removal and enforcement of this
regulation especially during warmer weather. In addition there is emerging information that at
end stage disease, infectivity may also be included in additionai tissues such as peripheral nerves
(Buschmann and Groschup, 2005).
Leaving the tissues from these cattle in the animal feed chain will effectively nullify the intent of
this regulation. This point is illustrated by the 2001 Harvard risk assessment model which
demonstrated that eliminating dead and downer, 4D cattle, from the feed stream was a
disproportionately effective means of reducing the risk of re-infection “The disposition of c&e
that die on the farm would also have a substantial influence on the spread of BSE if the disease
were in traduced. ” The base case scenario showed that the mean total number ofID.50~ (i.e.,
dosage sufficient to infect SO percent of exposed cattte) from healthy animals at slaughter
presented to the food/feed system was 1500, The mean total number of ID.50.s from adult cattle
Division of Dockets Management (HFA-305)
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9 December 2005
deadstockpresented to the feed system was 3 7,000.
deadstock).
This illustrates the risk of “40 cattle” (i.e.,
From the Harvard Risk Assessment, 2001, Appendix 3A Base Case and Harvard Risk
Assessment, 200 1 Executive Summary
Serologicals and companies like ours which supply components of drugs and biologicals have a
responsibility to the manufacturers of these products, the medical community and their patients
as well as regulatory agencies throughout the world to provide the safest products as possible.
Since there is no test for BSE in live cattle or for product, the regulatory agencies throughout the
world expect us to reduce or eliminate risk via suurcing criteria, These parameters may include
but not be limited to country of origin, herd of origin, age of the animal, etc. The United States
is no longer a country with negligible risk, hence individual animal criteria has become more
important. In fact other Centers of the FDA have stated that more attention should be given to
sourcing from herds likely to be a source of BSE free animals. The exemptions in the current
ban as well as in the newly proposed rule make this difficult if not impossible as there are still
legal avenues for ruminants to consume potentially contaminated ruminant protein. In addition,
the USDA still has not implemented a system of identification and traceability.
Serologicals urges agencies of the US government to work with academia and industry on
research in the following areas:
e Methods to inactivate TSEs agents which then may allow a product to be used and even
fed to animals without risk
l Alternative uses for animal byproducts which would maintain value
Serologicals will continue to work with the FDA and other government agencies to implement a
strong BSE risk control program, Serologicals would like to reiterate our opinion that for the
FDA to provide a more comprehensive and protective feed ban, specified risk materials (SRMs)
and deadstock mu