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EXHIBIT
1
INTERNATIONAL
ORGANIZATION GUIDELINES
Source: WHO, OIE, FAO/CODEX ALIMENTARIUS COMMISSION
EXHIBIT
2
STRUCTURE
OF RISK ANALYSIS RECOMMENDED BY THE FAO
Source: FAO/CODEX ALIMENTARIUS COMMISSIONEXHIBIT
3
OFFICE
OF INTERNATIONAL EPIZOOTICS
The Office of International Epizootics’ (OIE’s)[1]
International Animal Health Code sets out minimum surveillance and
monitoring requirements for BSE. These requirements are: 1.
Compulsory notification and clinical investigation of suspect
cases. 2. Risk assessment that identifies potential hazards for BSE occurrence, including:
i) importation of animals or embryos/ova which are potentially infected with a transmissible spongiform encephalopathy (TSE); or ii) importation and feeding of potentially contaminated animal feedstuff to cattle;
i) consumption, by cattle, of contaminated, animal-derived proteins arising from TSE-infected animals and rendering processes that do not inactivate the agent; or ii)
potential vertical transmission of BSE from cows originating from
infected countries. 3.
Continuous BSE surveillance and monitoring with emphasis on the
risks identified in point 2 above. 4. Examination in an approved laboratory of brain material
from cattle older than 20 months displaying signs of progressive
neurological disease in accordance with the diagnostic techniques set
out in the Manual. A sufficient number of investigations as indicated in
Table I of the Guidelines for Continuous Surveillance and Monitoring of
BSE (Appendix VUlb of document 65 SG/ 12/CS1) should be carried out
annually in countries where progressive neurological disease incidence
is low. Surveillance should be targeted at cattle older than four years
of age that display other progressive disease conditions. 5. Maintenance of seven years of records that track the
number and results of investigations. In addition, the OIE's International Animal Health
Code offers guidelines for determining a country's BSE status. According
to Chapter 3.2.13.2 of the Code, countries may be considered free of BSE
if: 1. They have implemented a risk management strategy to address any
risk, as identified in Article 3;2.13.1 point 2); and 2. They have effectively enforced a ban on feeding cattle
meat-and-bone meal derived from ruminants from TSE-infected countries or
countries that do not have an effective and continuous surveillance and
monitoring system as described in Article 3.2.13.1points 3) and 4); AND 1.
There has been no clinical case of BSE, the disease is notifiable,
and an effective and continuous surveillance and monitoring system is
practiced, as described in Article 3.2.13.1 points 3) and 4); or 2.
All cases of BSE have been clearly demonstrated to originate
directly from the importation of live cattle originating from BSE-infected
countries, provided that the disease is made notifiable and suspect
animals are slaughtered, investigated and, if disease is confirmed,
completely destroyed and an effective and continuous surveillance and
monitoring system is practiced, as described in Article 3.2.13.1 points
3) and 4), or 3. BSE has been eradicated (under study). [1] An international veterinary organization. EXHIBIT
4
WORLD
HEALTH ORGANIZATION In order to protect public health
from any potential risk from animal TSEs, the World Health Organization
(WHO) recommends that: ·
No part of any animal which has shown signs of a TSE
should enter into any food chain—human or animal; ·
All countries should ensure the killing and safe disposal
of all parts or products of such animals so that TSE infectivity cannot
enter any food chain; and ·
All countries should review their rendering procedures to
ensure that they effectively inactivate TSE agents. With
regard to surveillance and other BSE issues, WHO has recommended that: ·
All countries should establish continuous surveillance and
compulsory notification for BSE according to recommendations established
by the OIE in Paris. In the
absence of surveillance data, a country’s BSE status must be
considered as unknown. ·
Countries where BSE exists in native cattle should not
permit tissues that are likely to contain the BSE agent to enter any
food chain—human or animal. ·
All countries should ban the use of ruminant tissues in
ruminant feed. EXHIBIT
5
CODEX
The WTO Agreement on Sanitary and
Phytosanitary Measures (SPS) refers to the standards, guidelines, and
recommendations established by the FAO Codex Alimentarius Commission
relating to various food safety issues. At
an FAO Expert Consultation on Animal Feeding and Food Safety held in
Rome March 10-14, 1997, guidelines for the control of feed-borne hazards
were introduced. Although
it has not been proven that BSE is a feed-borne hazard, the Expert
Consultation concluded that it would not be “prudent” to exclude BSE
as a “potential food-borne hazard.”
The group concluded that “the risk that arises from [BSE]
should be assessed and managed in exactly the same way as other
food-borne hazards.” Codex
provides guidelines for analyzing this risk, based upon structured risk
assessment, risk management, and risk communication. Specific
guidance given with respect to BSE includes taking the following
measures: ·
All tissues from cattle with clinical BSE should be
incinerated so that they are eliminated from all feed and food chains. ·
In all countries where BSE has occurred, depending upon
its incidence (as determined by a “competent authority and an
appropriately structured surveillance program”), consideration should
be given to placing restrictions on the use of meat-and-bone meal
derived from specific bovine tissues in ruminant feeds.
A similar consideration should be made in countries where a risk
assessment indicates that the cattle population has been exposed to
infection. ·
In countries where BSE and sheep scrapie have occurred,
consideration should be given to placing restrictions on the use of
ruminant-derived protein in feeds for ruminants. · In countries where BSE has not occurred, but where sheep scrapie is present, consideration should be given to placing restrictions on the feeding of bovine-derived protein to ruminants—depending on the incidence (as determined by a “competent authority and an appropriately structured surveillance program”) of scrapie and the time/temperature processes used for the rendering of bovine carcasses and tissues. EXHIBIT
6
U.S.
BSE SURVELLANCE PROGRAM
An
important part of AMA’s strategy for convincing the EU to grant the
United States BSE-free status is to use the media to mobilize support
from domestic and European communities. Domestic
Strategy AMA
must balance its domestic strategy very carefully. Any media attention
could confuse the public about the safety of U.S. beef. Accordingly, AMA
may want to keep a low profile and avoid using the media. On the other
hand, AMA could use the media to reassure the public that U.S. beef is
safe. Since
the U.S. government already supports our position, AMA could use a
Washington-focused media strategy to help ensure that the government
gives this issue top priority. Such a strategy would target Congress and
the Administration and would include placing op-ed pieces and letters to
the editor in D.C. publications. Additionally, AMA could post
information about meat industry safety on AMA and coalition web sites,
as well as provide links to other resources, such as APHIS and FSIS. European
Strategy The main priority with respect to the media should be to convince the EU public of the safety of U.S. animal products. AMA must implement a comprehensive media strategy that reassures opponents and gives our EU allies adequate facts to bolster their domestic efforts. AMA should: · Conduct a press conference with other coalition members to share the facts about the United States’ clean BSE record and the potential consequences of the EU’s ban; · Purchase advertising time on radio and television and in prominent publications (newspapers, journals, magazines) that target European consumers, governments, industries, and the Commission; · Target editorial writers in publications such as the Financial Times, which is widely read by those involved in EU decision-making; · Publish op-ed pieces and letters to the editor in European publications to target EU consumers, governments, industries, and the Commission; · Post information about meat industry safety on AMA and coalition web sites in European languages, as well as provide links to other resources, such as APHIS and FSIS; ·
Publish op-ed pieces and letters to the editor in European
publications to inform the public, as well as EU industries and
governments, about the safety of U.S. animal products. EXHIBIT
8 SAMPLE
LETTER TO A POTENTIAL U.S. COALITION MEMBER
Dear
Sir or Madame: As
your organization is well aware, the European Union is planning to ban
the sale of products that may contain, or are made using, specified risk
materials for Bovine Spongiform Encephalopathy (BSE). Our organizations
have much to gain from preventing implemention of this costly trade
barrier. I
am writing to propose that we explore opportunities for forming a
coalition to ensure that the EU ban does not block our exports. Together
we can make certain the U.S. government makes this issue a high priority
and continues to pressure the EU to exempt the United States from its
ban based on our BSE-free status. The
ultimate goal of our coalition would be to ensure that the EU grants the
United States BSE-free status and does not disrupt the flow of U.S.
exports to the EU. Our intermediate goal would be to increase political
awareness of this issue in Washington. We can coordinate our efforts to
educate members of Congress, providing them the real facts about (1) the
safety of U.S. animal products subject to the EU ban, and (2) the
potential negative impact the EU ban will have on U.S. exports and U.S.
jobs. More importantly, we can work together to secure allies in the EU
and reassure EU consumers, industries, the European Commission, and EU
member states about the safety of our products. With your support we can begin immediately to
coordinate our efforts and ensure that the EU recognizes the United
States as BSE-free. A coordinated effort will undoubtedly go a long way
toward protecting the interests of our members and promoting safe U.S.
products. Thank you for your time and support. Sincerely, President EXHIBIT
9
SAMPLE LETTER TO MEMBER OF CONGRESS
Dear Senator: I am writing to you on behalf of the American Meat
Association concerning the proposed EU ban on animal products that
contain specified risk materials for Bovine Spongiform Encephalopathy (BSE),
the so-called “mad cow disease." If implemented, this ban will
prevent $126 million in tallow exports to the EU. For Americans working
in the U.S. livestock and rendering industry, the ban would be
devastating. Since
the United States has not had any cases of BSE and maintains a rigorous
monitoring system, it qualifies as BSE-free, and international
organizations have recognized the United States as such. The EU,
however, has refused to recognize our BSE-free status. Moreover, it has
not provided scientific evidence to justify this decision—although
such evidence is required by the WTO Agreement on the Application of
Sanitary and Phytosanitary Measures. In short, the EU ban is a trade barrier that
violates World Trade Organization rules and will prevent us from
exporting our products to the EU. American companies, as well as European consumers,
need to be assured that we will be able to continue to provide the EU
market with our safe products. We gratefully acknowledge the U.S.
government's efforts to resolve this issue with the EU, but we also want
to encourage the Administration to step-up its efforts to find a
satisfactory solution to the problem. As you are aware from your past experience working
in the livestock industry, our industry is committed to providing
consumers around the world with safe products. If implemented, the
EU’s ban will result in undeniable damage to our industry, as well as
animal product dependent industries. Senator, your support for the swift resolution of
this problem would be very much appreciated. Sincerely, President
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EXHIBIT
18 – INTEREST CHART 1 (of 8)
|
PARTY |
INTERESTS |
OPTIONS |
OBJECTIVE
CRITERIA |
BATNA |
|
American Meat
Association (AMA) |
Prevent EU ban |
·
Get recognition of U.S. as
BSE-free ·
Pressure USTR/USDA to make
this issue a high priority ·
Work with other parties to
pressure/lobby EU ·
Lobby Congress to support
AMA’s position |
SPS Agreement OIE Guidelines WHO Recommendations CODEX Recommendations |
Take
to WTO
|
|
Obtain
BSE-free status for the U.S. |
·
Use certification from
int’l organizations (OIE) to pressure EU ·
Produce study to compare US
with other countries recognized by the EU as BSE-free (Australia) ·
Lobby USDA to allow EU to
take a role in US inspections ·
Provide EU with data to prove
the U.S.’s BSE-free status according to the OIE International Animal
Health Code |
|||
|
Prevent the EU ban
from affecting additional products |
·
Inform USDA/USTR on the lack
of evidence that BSE can be transmitted to other animals (horizontal
transmission) ·
Ask USDA to fund BSE studies
and procedures for other animals, to which the EU might extend the ban ·
Prove that other products are
safe from BSE |
|||
|
Promote members’
interests at home and abroad;
increase exports; protect high-quality reputation of products |
·
Increase marketing efforts
(in EU) ·
Start a BSE-free label for
meat and products ·
Target new markets, diversify
products ·
Ensure recognition of BSE-free
status |
|||
|
Ensure implementation
of EU commitments to accept US imports |
·
Lobby USDA/USTR to get
assurance from EU ·
Lobby to allow US to
retaliate in event that EU does not carry out its end of any deal ·
Export to countries that are
more likely to accept US imports |
|||
|
Make interests of AMA
known to the EU public |
·
Educate public, provide
on-line information ·
Increase active public
outreach activities and response plans ·
Target youngsters ·
Participate with other
interested parties in an education initiative |
|||
|
Preserve relationship
with USDA and USTR |
·
Offer support for both
agencies efforts while encouraging them to continue to press the EU |
|||
|
Provide consumers with
safe products |
·
Initiate a separate
inspection program for AMA members ·
Sponsor or work with APHIS to
continue to train processors to identify possible signs of BSE ·
Offer to provide funding for
additional educational programs |
EXHIBIT 18 – INTEREST CHART 2
(of 8)
|
PARTY |
INTERESTS |
OPTIONS |
OBJECTIVE
CRITERIA |
BATNA |
|
European
Union/ Commission |
Protect the health of EU animals from BSE |
·
Implement ban on SRMs ·
Prevent import of any
products/parts that have risk of transmitting disease ·
Prevent import of
products/parts from countries with high risk for BSE |
SPS Agreement OIE Guidelines WHO Recommendations CODEX Recommendations |
Do nothing; Implement
the ban as is and risk being taken to the WTO |
|
Protect the health of
EU citizens from BSE/CJD; ensure availability of medical products; ensure
safety of food supply |
· Implement the ban on SRMs ·
Allow import of products
necessary to save lives of EU patients, regardless of whether they have
SRMs ·
Establish a certification
system for products with no SRMs |
|||
|
Maintain good
relations with US and other trading partners |
·
Negotiate derogations for the
ban ·
Implement ban with differing
levels of application, depending on risk level ·
Conduct talks with other
trading partners concerning the potential impact of the ban on them |
|||
|
Maintain Commission
“sovereignty”/authority on EU trade matters |
·
Try to keep member states out
of the negotiations ·
Try to keep member states
happy; build their trust, involve them as much as possible |
|||
|
Prevent
disagreement/promote agreement between Commission and member states |
·
Keep US interests in mind ·
Treat all member states
equally |
|||
|
Avoid granting
exemptions for EU member states |
·
Don’t grant exemptions for
any other nation |
|||
|
Promote international
trade norms; avoid being taken to WTO |
·
Follow WTO guidelines |
EXHIBIT
18 – INTEREST CHART 3 (of 8)
|
PARTY |
INTERESTS |
OPTIONS |
OBJECTIVE
CRITERIA |
BATNA |
|
EU Standing
Scientific Committee (SSC) |
Use only most reliable
scientific evidence when making recommendations |
·
Follow international
guidelines ·
Don’t make far-fetched
interpretation of scientific evidence just to meet the needs of the
Commission |
SPS Agreement OIE Guidelines WHO Recommendations CODEX Recommendations |
Maintain status quo |
|
Advise Commission and
ensure SSC’s role in decision-making |
·
Tell Commission what it wants
to hear ·
Work to de-politicize
membership, make SSC membership last longer to reduce Commission’s
ability to pressure SCC and ensure membership is based solely on merit |
|||
|
Protect EU animals and
human health |
·
Suggest Commission implement
the ban ·
Follow international
guidelines and sound science ·
Conduct own research on these
issues |
|||
|
Protect reputation as
independent, fair and knowledgeable |
·
Follow international
guidelines ·
Make decisions based on sound
science ·
Consistently remain
independent of Commission |
EXHIBIT
18 – INTEREST CHART 4 (of 8)
|
PARTY |
INTERESTS |
OPTIONS |
OBJECTIVE
CRITERIA |
BATNA |
|
EU Pharma-ceutical
Community |
·
Sell its products at home |
·
Ensure their safety ·
Don’t use SRMs ·
Develop non-SRM method of
production |
SPS Agreement OIE Guidelines WHO Recommendations CODEX Recommendations |
Maintain status quo |
|
·
Sell products abroad
(increase exports) |
·
Marketing-safety |
|||
|
·
Ensure safety of products and
materials used to create pharmaceutical products ·
Ensure health, safety of
consumers |
·
Don’t use SRMs ·
Use only BSE-free SRM inputs ·
Support EU ban |
|||
|
·
Ensure reputation for
providing high-quality products |
·
Marketing and efforts to
distinguish EU products from US (as free from SRMs) ·
Ensure products are safe |
|||
|
·
Create new products ·
Obtain funding for research ·
Obtain approval for new
products |
·
Increase R&D efforts ·
Work with US companies |
|||
|
·
Maintain relationship with EU
authorities |
·
Work with them to ensure
safety standards and quality |
|||
|
·
Prevent imports (protect
domestic market share) |
·
Increase marketing ·
Support ban |
|||
|
·
Obtain required inputs from
foreign suppliers |
·
Don’t support ban ·
Use imports from BSE-free
countries ·
Don’t use SRMs |
EXHIBIT
18 – INTEREST CHART 5 (of 8)
|
PARTY |
INTERESTS |
OPTIONS |
OBJECTIVE
CRITERIA |
BATNA |
|
EU Member
States with no Native BSE |
Protect reputation of
products |
·
Obtain exemption from ban ·
Ensure safety, quality,
monitoring/prevention/education for BSE |
SPS Agreement OIE Guidelines WHO Recommendations CODEX Recommendations |
Maintain status quo |
|
Obtain BSE-free status |
·
Push Commission to grant
status ·
Continue to monitor safety of
domestic beef, etc. to demonstrate commitment to remaining BSE-free |
|||
|
Protect food supply,
consumers, human health |
·
Inspection of food supply ·
Implement ban |
|||
|
Protect animal health
(from BSE) |
·
Inspection system ·
Import restrictions-like ban ·
Prevention, education methods |
|||
|
Show Commission the
states are important (limit Commission’s power/competence) |
·
Withhold support for ban
unless member states with no BSE get exemptions ·
Ensure members states
maintain some authority in trade issues |
|||
|
Distinguish themselves
from UK |
·
Uphold support for ban ·
Demand exemptions |
|||
|
Promote exports |
·
Lobby to remove US
ban/limitations on imports ·
Marketing efforts ·
Distinguish from UK |
|||
|
Promote international
trade norms |
·
Ensure Commission follows WTO
guidelines ·
Communicate with other member
states concerning ban |
EXHIBIT
18 – INTEREST CHART 6 (of 8)
|
PARTY |
INTERESTS |
OPTIONS |
OBJECTIVE
CRITERIA |
BATNA |
|
United Kingdom |
Protect animal health
from BSE |
·
Implement ban on SRMs ·
Prevent import of any
products/parts that have risk of transmitting disease |
SPS Agreement OIE Guidelines WHO Recommendations CODEX Recommendations |
Maintain status quo |
|
Protect human health,
consumers |
·
Implement ban on SRMs ·
Allow products that are
necessar to save lives of EU patients, regardless of whether they have
SRMs ·
Establish a certification
system for products with no SRMs |
|||
|
Increase exports |
·
Marketing ·
Ensure safety of products |
|||
|
Protect right to
establish own, separate ban |
·
Lobby Commission for support |
|||
|
Implementation of EU
ban (on April 1) |
·
Lobby Commission ·
Lobby other EU member states |
|||
|
Prevent spread of BSE |
·
Scientific inspections ·
Prevention initiatives ·
Education initiatives ·
Support ban |
EXHIBIT
18 – INTEREST CHART 7 (of 8)
|
PARTY |
INTERESTS |
OPTIONS |
OBJECTIVE
CRITERIA |
BATNA |
|
United States
Trade Represen-tative (USTR) |
Prevent EU ban |
·
Negotiate derogations with EU ·
Push for BSE-free status |
SPS Agreement OIE Guidelines WHO Recommendations CODEX Recommendations |
Take EU to WTO |
|
Promote US exports |
·
Marketing ·
Ensure ban in removed ·
Bilateral
agreements-negotiations |
|||
|
Obtain BSE-free status |
·
Lobby EU ·
Lobby member states ·
Work with industries to get
science right |
|||
|
Ensure implementation
of EU exceptions (also only high-quality exceptions) |
·
Lobby EU ·
Negotiate with EU ·
Take EU to WTO |
|||
|
Ensure international
trade norms used |
·
Follow WTO obligations, use
DSB to take EU to WTO DSB ·
Encourage EU to follow the
WTO obligations |
|||
|
Preserve relationship
with USDA, EU Commission |
·
Negotiate with objective
criteria as basis ·
Separate negotiations from
personal contacts · Make efforts to preserve relationship outside of negotiations/official busines |
EXHIBIT 18 – INTEREST CHART 8 (of 8)
|
PARTY |
INTERESTS |
OPTIONS |
OBJECTIVE
CRITERIA |
BATNA |
|
U.S. Dept. of
Agriculture (USDA) |
Prevent EU ban |
Work with USTR to
lobby EU and push for BSE-free
status |
SPS Agreement OIE Guidelines WHO Recommendations CODEX Recommendations |
Take EU to WTO |
|
Promote US exports |
Work with USTR to
negotiate market access agreements Target new markets Provide exporters with
market access information, tips, etc. |
|||
|
Obtain BSE-free status |
Work with USTR Ensure that US
monitoring system meets all guidelines set by the OIE International Animal
Health Code |
|||
|
Ensure implementation
of EU commitments; accept only high-quality exemptions |
Work with USTR (see
USTR #4) |
|||
|
Preserve relationship
with USTR, EU |
Work to keep personal
relationship separate from official business, (see USTR #7) |
|||
|
Ensure safety of US
food supply (protect human health) |
Continue BSE
surveillance and monitoring system |
|||
|
Ensure animal health
(from BSE) |
Continue BSE
surveillance and monitoring system Protect domestic
animals Import controls |