FTA talks get off to a shaky start
BIG SKY, Montana - Seoul and Washington began their fifth round of free
trade negotiations in the U.S. state of Montana, faced with the challenge of
making progress in sensitive areas such as agriculture, pharmaceuticals and
tariff rates.
"We have made very little progress in the talks (today)," Korea's top
negotiator Kim Jong-hoon told reporters. "But my counterpart Wendy Cutler
and I agreed that it is important to make progress on major issues in this
round, because it is the final round of talks this year."
Both countries are holding five days of talks at a ski resort in Big Sky.
They hope to conclude negotiations by March to seal a trade pact by July
2007, the expiration of the Bush administration's fast-track trade promotion
authority. But thorny issues including the U.S. demand for wider access to
Korea's agriculture and automobile markets, pharmaceutical sector, and
Korea's demand for wider access to the U.S. textile market have not yet made
any progress, raising doubts over the possibility of meeting the deadline.
"For an agreement to be sealed we must be creative and make tough political
decisions," Wendy Cutler, chief U.S. negotiator and assistant trade
representative, said at a news conference.
In line with making "tough political" decisions, the United States has been
aggressively lobbying for Korea to reopen its market to U.S. beef ahead of
the talks, even though beef import safety issues do not fall within the
purview of the FTA. Seoul's rejection of two recent shipments of American
beef after the detection of bone fragments has heightened a beef trade
dispute, intensifying the political tension between the two countries.
"Technically it is correct that our talks to reopen the beef market are not
part of the KORUS (Korea-U.S.) negotiations," said Cutler. "However, we've
made it very clear to our Korean counterparts that in order for a successful
Korea-U.S. FTA to be ratified by our Congress, we need to see the full
reopening of Korea's beef market to U.S. beef."
Seoul's top negotiator confirmed that beef and the FTA are separate issues.
But he agreed that the beef dispute could have a negative effect when it
comes to the U.S. Congress signing off on the agreement.
"I do agree that the beef issue may obstruct the U.S. Congress in its
decision in passing the FTA, but we can only wait and see how much
importance Congress places on the beef issue when the time comes for them to
decide whether to pass the agreement," Kim told reporters. "So beef
shouldn't affect the contents of our FTA."
Part of the U.S. political effort includes holding the FTA talks in Montana,
which is part of the beef belt in the United States. Korea was the
third-largest market for U.S. beef before Seoul began an import ban in
December 2003 following the discovery of a case of mad cow disease in
Washington state.
"U.S. beef is safe with or without bones," said Democratic Senator Max
Baucus from Montana at a luncheon with Korean officials and the chief
negotiators a day ahead of the talks. "I hope our beef can be freely sold in
the Korean market."
Kim said making progress in trade remedies will be important for advancing
the overall negotiations in this fifth round. The Bush administration has
until this year to secure a draft for trade remedies.
"I stressed that making progress on trade remedies is important in this
round," Kim said.
While Korea faces the challenge of persuading strong FTA opponents at home,
such as the farming and movie industries, over their fears of losing
competitiveness against a flood of U.S. products, it needs to resolve
automobile and pharmaceuticals issues.
"We are extremely disappointed with the progress (in pharmaceuticals)," said
Cutler. "This is a very important issue for us in the negotiations that our
suggestions were not incorporated or reflected in the draft regulation that
Korea is now finalizing and intends to put into place by the end of the
year."
Washington opposes the Korean government's medicine reimbursement policy,
citing potential discrimination against U.S. pharmaceutical companies.
"We remain extremely concerned that Korea is going forward with regulations
that in our view will deny Korean patients treatment with the most
innovative drugs in the world," stressed Cutler.
Kim in response admitted that he was "very disappointed" at what Cutler
said, stressing that U.S. negotiators had earlier accepted Korea's new
pharmaceutical regulation that is to be enforced by the end of this year.
Pressure is also intensifying for Seoul to ease its trade barriers for
automobiles.
"I think what happens in autos during this round will be largely dependent
on how responsive Korea is to our proposal to address the range of
non-tariff measures that impede access to our companies in Korea," declared
Cutler.
She cited high taxes and discriminatory and non-transparent standards as
barriers for U.S. automakers.
Kim, however, expressed some optimism.
"We stressed that sensitive areas need to be addressed in this round," he
told reporters.
(
[email protected])
By Yoo Soh-jung
2006.12.06
http://www.koreaherald.co.kr/SITE/data/html_dir/2006/12/06/200612060039.asp
Greetings,
>>>"Technically it is correct that our talks to reopen the beef market are
not part of the KORUS (Korea-U.S.) negotiations," said Cutler. "However,
we've made it very clear to our Korean counterparts that in order for a
successful Korea-U.S. FTA to be ratified by our Congress, we need to see the
full reopening of Korea's beef market to U.S. beef." <<<
hmmm, blackmail by proxy, that seems to be America's way now. seems GW et al
will force feed everyone there BSe via the BSE MRR policy, the legal Trading
of all strains of TSE globally. ...
>>>"U.S. beef is safe with or without bones," said Democratic Senator Max
Baucus from Montana at a luncheon with Korean officials and the chief
negotiators a day ahead of the talks. "I hope our beef can be freely sold in
the Korean market."<<<
My God, another political idiot, playing like he knows about TSE, in line
for the Gummer award, long with GW et al, and
Prime Minister Jean Chretien lying to the public about Canadian beef at a
Ottawa restaurant ;
http://news.bbc.co.uk/onthisday/hi/dates/stories/may/16/newsid_2913000/2913807.stm
http://www.maddeer.org/canadianprimeminister.JPG
we must get politics and trade out of TSE science, if it is not to late
already. ...
>>>While Korea faces the challenge of persuading strong FTA opponents at
home, such as the farming and movie industries, over their fears of losing
competitiveness against a flood of U.S. products, it needs to resolve
automobile and pharmaceuticals issues. <<<
PHARMACEUTICALS AND TSE
i wonder if the kind people of S Korea are aware of TSE and what the SEAC
has said about FDA USA medical implants and risk factor there ???
in case they might have missed this, here it is ;
USA GBR
15. USA was initially assigned GBR II by the SSC in 20007. A
reassessment by EFSA in 2004 changed the level to GBR III8 (see
Annex 1). This was based upon:
(i) the extent of external challenge since 1980. The USA imported
cattle and MBM from BSE risk countries, including the UK, during
periods of time when a risk of importation of infected animals and
contaminated feed existed (see pages 2-8 of the technical annex at
Annex 1).
(ii) the stability of USA system to mitigate against the external
challenge since 1980. The USA system was considered extremely
unstable such that should BSE infectivity have entered the system
it would have recycled and amplified quickly (see pages 8-14 of the
technical annex at Annex 1).
16. In 2005, BSE was confirmed from a reanalysis of sample collected
as part of routine surveillance from a single native USA animal that
died in 20049 supporting the change in GBR level.
SEAC CONSIDERATION
Implantable medical devices containing bovine material
17. MHRA recently identified a range of implants (heart valves, heart
valve conduits, vascular grafts and pericardial patches) on the UK
market that use bovine tissue (mainly pericardium) sourced from
an open herd in the USA. The devices were certified by a Spanish
Notified Body despite objections being made about the source of
the material by the UK and other Member States. The basis for the
Spanish certification was that no alternative devices would be
available until the manufacturer found another bovine source (i.e.
from a closed herd or from a GBR I country). However, since
these implants were sourced from an open herd in a GBR III
country, MHRA took the view that the TSE-related risk had not
been minimised and the products were removed from the UK
market.
7 http://europa.eu.int/comm/food/fs/sc/ssc/out137_en.pdf
8 http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573_en.html
9
http://www.aphis.usda.gov/lpa/issues/bse/epi-updates/bse_final_epidemiology_report.pdf
snip...full text 12 pages ;
http://www.seac.gov.uk/papers/91-2.pdf
i seem to recall mentioning all this back in 2000;
http://www.mad-cow.org/00/sep00_news.html#hhh
Two million children innoculated with BSE vaccines
http://www.mad-cow.org/00/may00_news.html#aaa
Recommendations for the Use of Vaccines Manufactured with Bovine-Derived
Materials
Bovine-derived materials have traditionally been used in the manufacture of
many biological products, including vaccines. Bovine spongiform
encephalopathy (BSE), so-called "mad-cow disease," was first recognized in
the United Kingdom (UK) in the 1980s(1). The Center for Biologics Evaluation
and Research (CBER) of the U.S. Food and Drug Administration (FDA) has been
concerned about eliminating any potential for contamination of biological
products with the BSE agent. This concern was heightened by the appearance
of the human transmissible spongiform encephalopathy known as variant
Creutzfeldt-Jakob Disease (vCJD, also referred to as new-variant CJD) in the
UK in 1996; vCJD has been attributed, among other possibilities, to eating
beef products from cattle infected with the agent of BSE (2). To date, there
are no reports of BSE contamination of pharmaceutical or biological
products. To minimize the possibility of contamination in such products, the
FDA, in 1993 (published in the Federal Register on August 29, 1994, 59 FR
44591), and again in 1996, recommended that manufacturers not use materials
derived from cattle that were born, raised, or slaughtered in countries
where BSE is known to exist; the FDA referred manufacturers to the listing
of such countries that is maintained by the U.S. Department of Agriculture
(USDA)(3).
In 1991 the USDA list included only countries and other regions in which BSE
was known to exist, such as France, Great Britain, Northern Ireland, the
Republic of Ireland, Oman, and Switzerland. In 1998, the USDA expanded the
list to include countries and other regions in which BSE had not been
documented but in which import requirements were less restrictive than
requirements that would be acceptable for import into the United States or
in which surveillance was inadequate. Thus, all European countries, even
those that have had no reported BSE cases, are currently on the USDA list,
which is published in the Code of Federal Regulations, title 9, part 94 (9
C.F.R. part 94).
In 2000, CBER learned that its recommendations regarding the sourcing of
bovine materials for the manufacture of vaccines had not been followed in at
least one instance. As a result of this finding, CBER requested all vaccine
manufacturers to review the source for all bovine-derived materials used in
the manufacture of their vaccines. This review identified additional
vaccines manufactured with bovine-derived materials that had been obtained
from European countries on the USDA list.
No evidence exists that any case of vCJD has resulted from the
administration of a vaccine product(4), and no cases of vCJD have been
reported in the United States. To evaluate the risk of disease that might
result from a vaccine manufactured with a process that utilizes bovine
materials potentially contaminated with the BSE agent, CBER conducted risk
assessments and convened a special joint meeting of the Transmissible
Spongiform Encephalopathy Advisory Committee and the Vaccines and Related
Biological Products Advisory Committee on July 27, 2000. In assessing the
potential risk of vaccines, CBER and the joint Committees considered: (1)
the likelihood that any cattle that were used might be infected (i.e., the
time period and country of origin) and animal husbandry procedures; (2) the
amount of bovine material that might be present in the final vaccine; and
(3) the inherent infectivity of the various types of bovine materials that
were used. The joint Committees concluded that the risk of vCJD posed by
vaccines in the scenarios that were presented was theoretical and remote.
They also noted that the benefits of vaccination far outweigh any remote
risks of vCJD. The joint Committees made several recommendations.
Bovine-derived materials used in the routine production of vaccines that are
sourced from countries on the USDA list should be replaced with
bovine-derived materials from countries not on the USDA list.
Working bacterial and viral seed banks and working cell banks that were
established using bovine-derived materials sourced from countries on the
USDA list should be re-derived with bovine-derived materials from countries
not on the USDA list. However, master bacterial and viral seed banks
established in a similar manner do not need to be re-derived; the potential
risk presented by the master seed banks is even more remote than that
presented by the working seed banks and is outweighed by the risk of
altering the bacterial or viral vaccine through re-derivation.
These issues are of public interest and, therefore, the public should be
informed about the safety of vaccines that used materials sourced from
countries on the USDA list, and the assessment of the nature of any risk of
vCJD from such vaccines.
As noted above, there is no evidence that any case of vCJD has been caused
by or is related to vaccines manufactured with bovine-derived materials
obtained from countries in which BSE or a significant risk of BSE exists
(i.e., countries on the USDA list), and thus the risk of vCJD is
theoretical. The joint Committees' recommendation to replace such
bovine-derived materials with bovine-derived materials from countries not on
the USDA list was a precautionary measure intended to minimize even the
remote risk of vCJD from vaccines.
The source of the bovine-derived materials may be unknown, in part because
manufacturers have not always maintained or had access to records of the
source of such materials, particularly in the 1980s and early 1990s, before
the connection between BSE and vCJD was first suggested (the current best
estimate is that BSE first emerged in 1980). Vaccines using bovine-derived
materials from a country on the USDA list or from an unknown source to
manufacture only the master seed are not listed on this website; the joint
Advisory Committees indicated that master seeds need not be re-derived.
Additional information on such vaccines can be obtained upon request.
The FDA requested that manufacturers of vaccines using bovine-derived
materials obtained from countries on the USDA list or from an unknown source
replace these materials with materials from countries not on the USDA list,
consistent with the recommendations of the joint Advisory Committees. The
manufacturers have fully implemented these changes. No US-licensed vaccine
uses bovine derived materials from countries on the USDA list.
The Public Health Service (PHS) recommends that all children and adults
continue to be immunized according to current immunization schedules(5). At
the present time, the PHS has no preference for using one licensed vaccine
product over another based on the source of bovine-derived materials used in
vaccine production. The recommendations of the FDA Advisory Committees and
the actions of the FDA are, as described, precautionary and have been taken
to reduce even the remote potential of a risk of vCJD and to maintain public
confidence in the safety of vaccines. Failure to obtain the recommended
vaccinations with licensed vaccines poses a real risk of serious disease.
References
Wells G.A.H. et al. 1987. A novel progressive spongiform encephalopathy in
cattle. Veterinary Record 121:419-420
Spongiform Encephalopathy Advisory Committee of UK statement of 20 March
1996 (http://www.defra.gov.uk/)
USDA 9 CFR part 94.18
P. D. Minor, R.G. Will and D. Salisbury. 2000. Vaccines and variant CJD.
Vaccine 19:409-410.
http://www.cdc.gov/nip/recs/child-schedule.htm;
http://www.cdc.gov/nip/recs/adult-schedule.pdf
Table of Contents
Transcripts of 27 July, 2000, Joint Meeting of the Transmissible Spongiform
Encephalopathy and Vaccines and Related Biologicals Products Advisory
Committees
On July 27, 2000, the Center for Biologics Evaluation and Research (CBER)
convened a special joint meeting of the Transmissible Spongiform
Encephalopathy and the Vaccines and Related Biological Products Advisory
Committees. The purpose of the joint meeting was to ask these committees to
consider the potential risks and possible actions that should be taken with
regard to licensed and investigational vaccines that contain bovine derived
material sourced from countries on the current USDA list of BSE-risk
countries. The transcripts of this meeting and copies of the briefing
materials provided to the committee members can be found at:
http://www.fda.gov/ohrms/dockets/ac/cber00.htm
Table of Contents
CBER and FDA Guidance on Sourcing of Bovine Derived Raw Materials
Letters to manufacturers and other guidance documents are part of the
mechanism by which regulated industry and the public are informed about
safety issues and expectations of the FDA regarding the development, testing
and licensure of vaccines. Although these documents do not have the force of
law, they do represent the current thinking of the agency on licensure and
control of FDA regulated products.
The following is a summary of the guidance documents and letters from FDA
and CBER which relate to the potential for contamination of products with
the agent that causes BSE.
Dear Biologic Product Manufacturer
In a May 1991 letter to manufacturers of biological products, CBER requested
information on sourcing and control of animal substances. Specifically CBER
asked for a list of materials of bovine origin used in the product or in
manufacture of the product, as well as supplier information and a
description of controls to assure and document the health and origin of the
animals used.
Points to Consider in the Characterization of Cell Lines Used for the
Production of Biologics
In a letter to manufacturers in July 1993 CBER asked manufacturers to review
the May 1993 revision of the 1987 document "Points to Consider in the
Characterization of Cell Lines Used for the Production of Biologics". In the
revised version of this document CBER indicated that manufacturers should be
able to provide detailed information on cell culture history, isolation,
media, identity, and adventitious agent testing of cell lines used in the
production of biological products.
Manufacturers of FDA-regulated Products
Since 1993 the FDA has recommended that bovine-derived material from cattle
which have resided in or originated from countries where BSE has been
diagnosed not be used for the manufacture of FDA-regulated products intended
for administration to humans. This letter referred to a list of countries
where BSE is known to exist - France, Great Britain (including the
Falklands), Northern Ireland, Oman and Switzerland. This list is maintained
by the USDA. The USDA has the authority to restrict the importation of
certain animals, birds, poultry, animals by-products, hay and straw into the
US in order to prevent the introduction of various animal diseases including
BSE.
Letter to Manufacturers of FDA-regulated Drug/Biological/Device Products
In 1996 following the appearance of vCJD CBER recommended that manufacturers
take whatever steps necessary to ensure they are not using bovine material
from cattle born, raised or slaughtered in BSE-countries. At that time the
BSE-list included France, Great Britain and the Falklands, Northern Ireland,
the Republic of Ireland, Oman, Switzerland and Portugal.
Guidance for Industry - The Sourcing and Processing of Gelatin to Reduce the
Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in
FDA-Regulated Products for Human Use
In September 1997 following an April 1997 TSE advisory committee review FDA
issued a guidance document for industry addressing the sourcing and
processing of gelatin to reduce the potential risk of transmission of BSE
through FDA-regulated products for human use.
1998 USDA Interim Rule on Import Restrictions of Ruminant Material from
Europe (FR 63(3):406-408, 1/6/98)
In January, 1998, the USDA updated the list of BSE-countries to include not
only those countries where BSE was known to exist but to include countries
where no case of BSE had been identified but which the USDA believed had
less restrictive import requirements than the US and/or inadequate
surveillance. This expansion applied all the USDA ruminant and import
restrictions to the whole of Europe, including those countries where BSE had
not been shown to exist.
Letter to Manufacturers of Biological Products: Recommendations Regarding
Bovine Spongiform Encephalopathy - (Text), (PDF)
In April 2000 CBER sent a letter to manufacturers requesting that ruminant
derived material from Europe not be used in the manufacture of FDA-regulated
products for humans.
http://www.fda.gov/cber/BSE/BSE.htm
THE INFAMOUS DEAR MAD COW VACCINE MANUFACTURE LETTER, kinda like the dear
mad cow nutritional supplements manufacturer letter;
Letter to Manufacturers of Biological Products
Recommendations Regarding Bovine Spongiform Encephalopathy (BSE)
Department of Health and Human Services
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
April 19, 2000
To Manufacturers of Biological Products
The Food and Drug Administration (FDA) has issued letters (date May 3, 1991,
December 17, 1993, and May 9, 1996) and a guidance document (September 1997)
requesting that materials derived from ruminants which have resided in or
originated from countries where Bovine Spongiform Encephalopathy (BSE) has
been diagnosed not be used in the manufacture of FDA-regulated products
intended for administration to humans. The United States Department of
Agriculture (USDA) also issued an interim rule on January 6, 1998,
restricting the importation of ruminants, meat and meat products from
ruminants, and certain ruminant products and byproducts from all countries
of Europe. Because of the serious nature of this issue, the Center for
Biologics Evaluation and Research (CBER) believes it critical to update the
current recommendations.
CBER strongly recommends that manufacturers take whatever steps are
necessary to assure that materials derived from all species of ruminant
animals born, raised or slaughtered in countries where BSE is known to
exist, or countries where the USDA has been unable to assure FDA that BSE
does not exist, are not used in the manufacture of FDA-regulated products
intended for administration to humans. The Agency has previously recommended
that manufacturers take the following steps to prevent this occurrence:
Identify all ruminant-derived materials (e.g., culture medium, transferrin,
albumin, enzymes, lipids) used in the manufacture of regulated products. FDA
considers the manufacture of biological products to include the preparation
of master (including the original cell line) and working cell banks, as well
as materials used in fermentation, harvesting, purification and formulation
of the products.
Document the country of origin and all countries where the live animal
source has resided for each ruminant-derived material used in the
manufacture of the regulated product. The regulated-product manufacturer
should obtain this information from the supplier of the ruminant-derived
product. The regulated-product manufacturer should also obtain the
appropriate veterinary regulatory inspection certification of slaughter, as
required by the country of origin of live animals, from the supplier.
Documentation should be maintained for any new or in-process lots of
licensed, cleared or approved products; products pending clearance or
approval; and investigational products intended to be administered to
humans.
Maintain traceable records for each lot of ruminant material and each lot of
FDA-regulated product manufactured using these materials. These records
should be part of the product batch records and available for FDA
inspection. Such records should be maintained for products manufactured at
foreign as well as domestic facilities.
It is the responsibility of the manufacturer to obtain up-to-date
information regarding countries where BSE is known to exist, or countries
where the USDA has been unable to assure FDA that BSE does not exist. This
information is available from the USDA's Animal and Plant Health Inspection
Service (APHIS) at telephone number 301-734-8364, website address
http://www.aphis.usda.gov/oa/bse/, and codified at 9 CFR 94.18 (see
attached).
Specific product-related questions should be directed to the appropriate
application division within CBER's product offices. The phone numbers are:
Dr. David Asher, 301-827-3524
Office of Blood Research and Review
Dr. Paul Richman, 301-827-3070
Office of Vaccines Research and Review
James Crim, 301-827-5101
Office of Therapeutics Research and Review
Thank you for your attention to this matter.
Sincerely,
--- signature ---
Kathryn C. Zoon, Ph.D.
Director
Center for Biologics Evaluation And Research
http://www.fda.gov/cber/ltr/bse041900.pdf
POT CALLING KETTLE BLACK
§94.18 Restrictions on Importation of Meat and Edible Products From
Ruminants Due To Bovine Spongiform Encephalopathy
Bovine spongiform encephalopathy exists in the following regions: Belgium,
France, the Republic of Ireland, Liechtenstein, Luxembourg, Oman, The
Netherlands, Portugal, Switzerland, and the United Kingdom.
The following regions, because of import requirements less restrictive than
those that would be acceptable for import into the United States and/or
because of inadequate surveillance, present an undue risk of introducing
bovine spongiform encephalopathy into the United States: Albania, Austria,
Bosnia-Herzegovina, Bulgaria, Croatia, the Czech Republic, Denmark, the
Federal Republic of Yugoslavia, Finland, Germany, Greece, Hungary, Italy,
the Former Yugoslav Republic of Macedonia, Norway, Poland, Romania, the
Slovak Republic, Slovenia, Spain, and Sweden.
A region may request at any time that the Administrator consider its removal
from a list set forth in paragraphs (a)(1) or (a)(2) of this section by
following the procedures set forth in §§92.2(b) (1) through (4), 92.2(b) (5)
through (11), and 92.2(c) of this chapter.
Except as provided in paragraph (d) of this section, the importation of
fresh, frozen, and chilled meat, meat products, and edible products other
than meat (excluding gelatin, milk and milk products), from ruminants that
have been in any of the countries listed in paragraph (a) of this section is
prohibited.
Gelatin. The importation of gelatin derived from ruminants that have been in
any region listed in paragraph (a) of this section is prohibited unless the
following conditions have been met:
The gelatin must be imported for use in human food, human pharmaceutical
products, photography, or some other use that will not result in the gelatin
coming in contact with reminants in the United States.
The person importing the gelatin must obtain a United States Veterinary
Permit for Importation and Transportation of Controlled Materials and
Organisms and Vectors by filing a permit application on VS form 16-3.17
The permit application must state the intended use of the gelatin and the
name and address of the consignee in the United States.
Transit shipment of articles. Fresh (chilled or frozen) meat, and edible
products other than meat, that are prohibited importation into the United
States in accordance with this section may transit the United States for
immediate export if the following conditions are met:
The person moving the articles must obtain a United States Veterinary Permit
for Importation and Transportation of Controlled Materials and Organisms and
Vectors by filing a permit application on VS form 16-3.18
The articles must be sealed in leakproof containers bearing serial numbers
during transit. Each container must remain sealed during the entire time
that it is in the United States.
The person moving the articles shall notify, in writing, the Plant
Protection and Quarantine Officer at both the place in the United States
where the articles will arrive and the port of export prior to such transit.
The notification must include the:
United States Veterinary Permit for Importation and Transportation of
Controlled Materials and Organisms and Vectors permit number;
Times and dates of arrival in the United States;
Times and dates of exportation from the United States;
Mode of transportation; and
Serial numbers of the sealed containers.
The articles must transit the United States in Customs bond.
(Approved by the Office of Management and Budget under control number
0579-0015)
[56 FR 63868, Dec. 6, 1991, as amended at 58 FR 65104, Dec. 13, 1993; 59 FR
24638, May 12, 1994; 59 FR 67616, Dec. 30, 1994; 62 FR 18264, Apr. 15, 1997;
62 FR 46181, Sept. 2, 1997; 62 FR 56023, Oct. 28, 1997; 62 FR 61434, Nov.
18, 1997; 62 FR 66000, Dec. 17, 1997; 63 FR 408, Jan. 6, 1998; 63 FR 4347,
Jan. 28, 1998; 63 FR 71210, Dec. 24, 1998; 64 FR 38550, July 19, 1999]
17 & 18 VS form 16-3 may be obtained from the Animal and Plant Health
Inspection Service, Veterinary Services, National Center for Import-Export,
4700 River Road Unit 38, Riverdale, Maryland 20737-1231.
Updated May 13, 2002
http://www.fda.gov/cber/ltr/bseattach.htm
NOW, bottom line, decades ago, medical authorities tried to warn NOT to use
SAFs i.e. scrapie associated fibers of any type in the manufacturing of
vaccines, this was in 1968, OOOPS, nobody listened here either, this
knowing full well what the Louping vaccine did decades ago killing thousands
of sheep from sheep scrapie via a scrapie contaminated vaccine i.e. the
Louping ill vaccine. ...
http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf
THE scientific community on the most part has also stated that the route by
inoculation is the most efficient mode of transmission with TSEs ;
8. The Secretary of State has a number of licences. We understand that
the inactivated polio vaccine is no longer being used. There is a stock
of smallpox vaccine. We have not been able to determine the source
material. (Made in sheep very unlikely to contain bovine ingredients).
http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf
although 176 products do _not_ conform to the CSM/VPC
guidelines.
http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf
Draft cover letter to product licence holders (considered by Human and Vet
Medicines including deer)
http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf
(It was noted with concern that hormone extracts could be manufactured by a
veterinary surgeon for administration to animals under his care without any
Medicines Act Control.)
http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/06/07010001.pdf
TWA LITTLE STATEMENT 331
http://www.bseinquiry.gov.uk/files/ws/s331.pdf
COMMERCIAL IN CONFIDENCE
http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf
NOT FOR PUBLICATION
http://www.bseinquiry.gov.uk/files/yb/1988/11/01012001.pdf
http://www.bseinquiry.gov.uk/yb/1988/11/04003001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf
TSS
