COMMISSION OF THE EUROPEAN COMMUNITIES 
Brussels, 12.11.1997 
COM(97) 566 final 
97/0301 (ACC) 
Proposal for a 
COUNCIL DECISION 
on the conclusion of the Agreement between the United States of America and the 
European Community on sanitary measures to protect public and animal health in trade 
in live animals and animal products 
(presented by the Commission) 

EXPLANATORY MEMORANDUM 
Background 
Since the Commission started making inspections of meat-exporting establishments in 
the USA in the mid 1980s, trade difficulties have arisen because of the differences in 
approach to health measures adopted by the EC and the USA. In order to overcome 
these trade problems, an agreement (the "red meat agreement") was negotiated in the 
early 1990s and adopted by the Council in October 19921. This Agreement recognized 
that the regulatory systems of both parties basically provide equivalent safeguards 
against public health risks. It set out the technical solutions needed to allow trade to 
continue and concluded that the two parties would initiate discussions as soon as 
possible on other problems in the veterinary field in relation to trade in animals and 
products of animal origin. 
Further impetus was given to these discussions by the entry into force on 1 January 
1995 of the WTO Agreement on the Application of Sanitary and Phytosanitary 
Measures (the SPS Agreement), which provides, in Article 4, that Members shall 
accept the sanitary measures of other Members as equivalent, even if those measures 
differ from their own, if the exporting Member objectively demonstrates to the 
importing Member that its measures achieve the importing Member's appropriate 
level of sanitary protection. This Article also requires Members, upon request, to enter 
into consultations with the aim of achieving bilateral and multilateral agreements on 
recognition of the equivalence of sanitary measures. 
On 20 February 1995, the Council agreed a mandate authorizing the Commission to 
conduct negotiations with a view to the conclusion of agreements between the 
Community and third countries on sanitary and phytosanitary measures, on the basis 
of negotiating directives annexed to its decision. 
Following this mandate, the Commission has, with the participation of experts from 
the Member States, conducted negotiations with a number of third countries. 
Agreements have been concluded with New Zealand and the Czech Republic, and 
negotiations are continuing with Australia, Canada, Uruguay, Chile and Argentina. 
This proposal presents the results of negotiations with the USA, which are now ready 
to be proposed to the Council. 
The legal base for the agreement is Article 113 and the first sentence of Article 228(2) 
of the Treaty, as in the case of the most recent agreement with the Czech Republic. 
Council Decision 93/158/EEC, OJ N° L 68, 19.3.1993, p. 1 
7^ 
Scope and purpose of the draft Agreement 
The draft Agreement covers sanitary measures affecting trade in the animals and 
animal products listed in Annex I of the text. However, due to the very significant 
differences in approach to certain measures, the draft Agreement excludes the matters 
referred to Article 3(2), including measures related to drug residues (e.g. hormones). 
These remain subject to the legislation of each party in respect of trade. 
The purpose of the draft Agreement is to facilitate trade between the parties in live 
animals and animal products by establishing a mechanism for the recognition of 
equivalence of sanitary measures where this is possible, and establishing a framework 
for working towards equivalence in other areas. 
For each party, equivalence can only be accepted in cases where the party is satisfied 
that the agreed conditions of trade meet its chosen level of sanitary protection. In all 
cases, it is the right of the importing party to determine if the measures of the 
exporting party meet its level of protection. The rights of parties under the WTO 
Agreements are not affected by the provisions of the draft Agreement, but the 
intention of the draft Agreement is to work towards mutually acceptable solutions 
instead of allowing damaging trade disputes to develop. 
Provisions are included for the exchange of information on matters relating to the 
draft Agreement, including specific provisions for the notification to each other of 
outbreaks of disease. A safeguard clause is also included, allowing parties to take 
unilateral emergency measures to protect human or animal health. 
The agreement makes reference to those responsibilities which fall to the Member 
States and those which are Community responsibilities (see Annex II.B). 
In effect, the Community is responsible for sanitary measures relating to the placing 
on the Community market of live animals and animal products, whether produced 
domestically or imported, while the Member States are responsible for ensuring 
compliance of exports with USA requirements. 
Joint Management Committee 
The draft Agreement establishes a Joint Management Committee with responsibilities 
for guiding the activities provided for in the text and for carrying out a regular review, 
at least once per year, of progress made in the recognition of equivalence. 
As the draft Agreement represents a starting point, and contains a very comprehensive 
work programme in Annex V, this Committee will play an important role in 
coordinating progress with the implementation of the programme. 
In addition, the Joint Committee may recommend changes to the Annexes as and 
when these become necessary as a result of progress in the continuing negotiations. 
1b 
Implementation of changes to the Agreement 
Each party will have to implement any agreed changes in accordance with its 
legislative procedures procedures (Article 16.2 of the Framework text). In the case of 
the Community, it is proposed to do this by Commission Decision, following an 
opinion of the Standing Veterinary Committee (3b "contrefilet" procedure). 
It should be stressed that nothing in this draft Agreement changes Community 
legislation; any such change which could be necessary in the future would have to 
been made by the Council and Parliament on the basis of Article 100A, if there are 
implications for public health, or any other appropriate legal basis. 
-7 c 
*^*';fJUv#ri 
PROPOSAL FOR A COUNCIL DECISION ^ 
on the conclusion of the Agreement between the United States of America and the ' 
European Community on sanitary measures to protect public and animal health in trade 
in live animals and animal products 
THE COUNCIL OF THE EUROPEAN UNION, . ; 
Having regard to the Treaty establishing the European Community, and in particular 
Article 113 and Article 228, paragraph 2, first sentence, thereof, 
Having regard to the proposal from the Commission, 
Wheieas the Agreement between the United States of America and the European 
Community on sanitary measures to protect public and animal health in trade in live 
animals and animal products provides an adequate means for putting into practice the 
provisions of the WTO Agreement on the Application of Sanitary and Phytosanitary 
Measures as regards public and animal health measures; 
Whereas the Agreement will contribute towards facilitating bilateral trade between the 
United States • of America and the European Community in live animals and animal 
products through the progressive recognition of the equivalence of sanitary measures, the 
recognition of animal health status, the application of régionalisation and the 
improvement of communication and cooperation; 
Whereas it. is appropriate to make provisions for a procedure establishing close and 
effective cooperation between the Commission and the Member States within the 
Standing Veterinary Committee; 
Whereas the Agreement should be approved on behalf of the Community, 
HAS DECIDED AS FOLLOWS: 
Article 1 
The Agreement between the United States of America and the European Community on 
sanitary measures to protect public and animal health in trade in liye animals and animal 
products is hereby approved on behalf of the Community. 
The text of the Agreement and the Annexes thereto are attached to this Decision. 
Article 2 
The President of the Council is hereby autliorised to designate the person empowered to 
sign the Agreement in order to bind the Community. 
1 d-
Article 3 
i'y'vâîî-:'' 
3|0t|||;^Trî^ measures' necessary for the implementation of this Agreement, including as regards 
"l^^^â^ineaf-randtmeat, based products guarantees equivalent to those laid down by 
^^^V6ïrectivâ7^462/EEC(I>, shall be established pursuant to the procedure laid down in 
« .^j«ç^?Ârticle 30' of that Directive..-, s ~ 
^-^^^PHfeSK-îC*-: « * ' • ••:$& • - '- • ::^A Article 4 
/.'•- - > ;^TheXommission, assisted by representatives of Member States' veterinary services, shall 
/s - -^represent: ^.Community in. the'Joint Management Committee referred to in Article 14 
Z (1) of the Agreement 
The Commission is authorized to approve modifications to the annexes to the Agreement 
of behalf of the Community, in accordance with the recommendations of the Joint 
Management Committee, pursuant to the procedure laid down in Article 29 of Directive 
72/462/EEC. 
Articles 
This Decision shall be published in the Official Journal of the European Communities. 
This Decision shall take effect on the date of its publication. 
Done at Brussels, 
For the Council 
The President 
(1) OJ. N° L 302, 31.12.1972, p. 28. Directive ZLS last amended by Directive Nc 
96/91/EC(OJ.N°L 13, 16.01.1996, p. 26). 
7<* 
DRAFT AGREEMENT 
between the United States of America and the European Community on 
sanitary measures to protect public and animal health 
in trade in live animals and animal products 
/ 
DRAFT AGREEMENT 
between the United States of America and the European Community on sanitary measures to protect public 
and animal health in trade in live animals and animal products 
THE GOVERNMENT OF THE UNITED STATES OF AMERICA 
ofthetme part, and 
THE EUROPEAN COMMUNITY 
of the other part, 
DESIRING to safeguard public and animal health and to facilitate trade in animals and animal products 
between the United States of America (hereinafter referred to as 'the U.S.') and the European Community 
(hereinafter referred to as 'the Community'); 
RESOLVED to take the fullest account of the risk of spread of animal diseases and the measures put in place 
to control and eradicate such diseases, and in particular to avoid disruptions to trade; 
REAFFIRMING their commitment to the rights and obligations established under the World Trade 
Organisation Agreement on the Application of Sanitary and Phytosanitary Measures (hereinafter referred to 
as the 'SPS Agreement'); 
WHEREAS the Parties acknowledge that their systems of sanitary measures are intended to address similar 
objectives of providing comparable health assurances; 
NOTING that the recognition by an importing country of the sanitary measures applied by an exporting 
country can permit greater efficiency in the utilization of inspection and verification resources; 
HAVE DECIDED to conclude this Agreement and to this end have designated respectively as their 
plenipotentiaries: 
THE GOVERNMENT OF THE UNITED STATES OF AMERICA 
THE EUROPEAN COMMUNITY 
WHO HAVE AGREED AS FOLLOWS: 
Article 1 
Objective 
The objective of this agreement is to facilitate trade in live animals and animal products between the U.S. and 
the Community by establishing a mechanism for the recognition of equivalence of sanitary measures 
maintained by a Party consistent with the protection of public and animal health, and to improve 
communication and cooperation on sanitary measures. 
Article 2 
Multilateral Obligations 
Nothing in this Agreement shall limit the rights or obligations of the Parties under the Agreement establishing 
the World Trade Organisation and its Annexes, in particular the Agreement on the Application of Sanitary and 
Phytosanitary Measures. 
Article 3 
Scope 
1. This Agreement shall initially be limited to the sanitary measures applied by either Party to the live 
animals and animal products listed in Annex I, except as provided for in paragraph 2. 
2. Unless otherwise specified under the provisions set out in the Annexes to this Agreement, this 
Agreement shall not apply to sanitary measures related to food additives, processing aids, flavours, 
colour additives, sanitary stamps, irradiation (ionisation), contaminants (including pesticides, 
chemical residues, mycotoxins, natural toxins, physical contaminants and animal drug residues), 
chemicals originating from the migration of substances from packaging materials; labelling of 
foodstuffs (including nutritional labelling); feed additives, animal feedingstuffs, medicated feeds and 
premixes. 
3. The Parties may agree to modify this Agreement in the future to extend the scope to other sanitary or 
phytosanitary measures affecting trade between the Parties. 
Article 4 
Regulatory Authorities 
1. The U.S. - regulatory authority for imports and exports of live animals and animal products is as 
described in part A of Annex II. 
2. The Community - control in veterinary affairs is as described in part B of Annex II. 
Article 5 
Definitions 
For the purposes of this Agreement the following definitions shall apply: 
(a) sanitary measures means sanitary measures as defined in Annex A, paragraph 1, of the SPS 
Agreement and falling within the scope of this Agreement. The reference to sanitary measures may 
cover individual sanitary measures or groups of sanitary measures for product areas, sectors, or parts 
of sectors, as appropriate; 
(b) appropriate level of sanitary protection means the appropriate level of sanitary protection as defined 
in Annex A, paragraph 5, of the SPS Agreement; 
(c) region means "zones" or "regions" as defined in the Animal Health Code of the Office 
International des Epizooties (OIE), and for aquaculture as defined in the International Aquatic 
Animal Health Code of the OIE; 
(d) Agreement means the entire text of this Agreement and all its annexes. 
Article 6 
Animal Health Status 
The importing Party shall recognise for trade the health status of regions, as determined by the 
exporting Party, with respect to the animal and aquaculture diseases specified in Annex III. 
2. The importing Party shall recognise régionalisation decisions taken by the exporting Party in 
accordance with the criteria set out in Annex IV as the basis for trade from a Party where art area is 
affected by one or more of the diseases listed in Annex III. 
3. Where a Party considers that it has a special status with respect to a specific disease other than those 
in Annex III, it may request recognition of this status. The importing Party may also request 
additional guarantees in respect of imports of live animals and animal products appropriate to the 
agreed status. The guarantees for specific diseases are specified in Annex V. 
The exporting Party shall, if requested by the importing Party, provide full explanation and supporting data for 
the determinations and decisions covered by this Article. The importing Party may, where necessary for the 
protection of animal health, invoke the provisions of Article 12. 
Article 7 
Equivalence 
In reaching a determination whether a sanitary measure maintained by an exporting Party achieves 
the importing Party's appropriate level of sanitary protection, the Parties shall follow a consultative 
process that includes the following steps: 
i) identification of the sanitary measure for which recognition of equivalence is sought; 
ii) explanation by the importing Party of the objective of its sanitary measure, including an 
assessment, as appropriate to the circumstances, of the risk or risks, that the sanitary 
measure is intended to address, and identification by the importing Party of its appropriate 
level of sanitary protection; 
iii) demonstration by the exporting Party that its sanitary measure achieves the importing 
Party's appropriate level of sanitary protection ; 
iv) determination by the importing Party whether a sanitary measure achieves its appropriate 
level of sanitary protection after consideration of various factors, including where 
appropriate: 
(a) risks identified by the importing Party and evidence provided by the exporting 
Party that its sanitary measures effectively address those risks; 
(b) provisions of the exporting Party's legislation and regulations regarding standards, 
procedures, policies, infrastructure, enforcement and control; 
(c) powers of the exporting Party's regulatory authorities and their structure, including 
their chain of command, modus operandi, and resources; 
(d) evidence provided by the exporting Party of the efficacy of its enforcement and 
control programs. 
The importing Party may carry out verification, as set out in Article 9, to assist this 
determination. 
2. In carrying out the consultative process described in paragraph 1, and setting the trade conditions 
referred to in Article 8.2 (b), the Parties shall take account of experience and information already 
acquired. 
3. Work under, or conclusion of, the consultative process for one product area, sector, or part of sector, 
shall not be dependent upon or delayed by work on any other product area, sector, or part of sector. 
4. The final determination whether a sanitary measure maintained by an exporting Party achieves the 
importing Party's appropriate level of sanitary protection rests solely with the importing Party acting 
in accordance with its administrative and legislative framework. 
Article 8 
Status of Consultations 
Annex V lists the live animals and animal product areas, sectors, or parts of sectors, and, for each 
area, sector or part thereof, sets forth the status of consultations regarding the recognition of 
equivalency of a Party's sanitary measures and the applicable trade conditions. 
a) With respect to sanitary measures recognised as equivalent for trade purposes at the date of 
entry into force of this Agreement, each Party, within its responsibilities, shall initiate the 
necessary legislative and administrative actions within 3 months to implement these 
recognitions. For sanitary measures that will be recognised as equivalent in the future, each 
Party shall take prompt and necessary steps to implement the recognitions. 
b) Where the trade conditions specified in Annex V include special conditions required by the 
importing Party to meet its appropriate level of protection, trade shall take place where the 
exporting Party meets the importing Party's conditions, without prejudice to the continuing 
consultative process. 
3. The Parties shall carry out the respective actions set out in Annex V, taking into account the target 
deadlines for each product area, sector, or part of sector, with a view, where possible, to reaching 
recognition of equivalence, and to facilitate trade. 
4. Annex V may be modified in accordance with Articles 14.2 and 16.2 to reflect changes made by 
each Party in recognitions or trade conditions. 
Article 9 
Verification Provisions 
1. The determination of the nature and frequency of checks to be applied to imports of live animals and 
animal products at external frontiers rests solely with the importing Party. Annex VII contains 
principles which shall guide such frontier checks. 
2. In addition to carrying out checks on imports at the external frontier, the importing Party may verify 
compliance with the provisions of this Agreement through the application of procedures which may 
include, but are not limited to: 
(a) an assessment of all or part of the exporting Party's total control programme, including, 
where appropriate, reviews of the exporting Party's inspection and audit programmes; and 
(b) on-site checks and inspections. 
3. The Community will carry out the verification procedures provided for in paragraph 2. The U.S. 
agencies identified in Annex II shall facilitate the performance of these verification procedures by 
the Community. 
4. The U.S. agencies identified in Annex II will carry out the verification procedures provided for in 
paragraph 2. The Community shall facilitate the performance of these verification procedures by 
those agencies. 
Upon the mutual consent of the Parties to this Agreement, either Party may: 
(a) share the results and conclusions of its verification procedures with countries that are not 
parties to this Agreement, or 
(b) use the results and conclusions of verification procedures carried out by countries that are 
not parties to this Agreement. 
Each Party shall carry out the verification procedures in accordance with Annex VI. The Parties may 
agree to modify Annex VI, taking due account of relevant work carried out by International 
Organisations. 
Article 10 
Information Exchange 
1. The Parties shall exchange information on a uniform and systematic basis to improve 
communication, to engender mutual confidence, and to demonstrate the efficacy of the programs 
controlled. Where appropriate, this may be supported by exchanges of officials between the Parties. 
2. The Parties shall notify each other of proposals to introduce new sanitary measures or to change 
existing sanitary measures, and shall provide the opportunity to comment on such proposals. 
3. In addition to information on changes in sanitary measures, the Parties shall also exchange 
information on other relevant topics including: 
current developments affecting trade in live animals and animal products, 
the results of the checks and verification procedures provided for in Article 9. 
4. Where a Party establishes, maintains or recognises a scientific committee, commission, expert group 
or other similar entity competent to study an issue relevant to this Agreement, the Party shall ensure 
timely consideration of, and response to, relevant scientific papers or studies submitted by the otlier 
Party. 
5. The Parties agree to establish an appropriate means of exchanging information on rejected import 
consignments, relevant inspection-related information, and other problem areas concerning public or 
animal health. 
6. The contact points for this information exchange arc set out in Annex IX. 
Article 11 
Notification 
1. Each Party shall notify the other: 
(a) immediately by oral communication followed within 24 hours in writing: of any serious or 
significant public or animal health risk, notably including any food control emergencies or 
situations where there is a clearly identified risk of serious health effects associated with the 
consumption of animal products; 
(b) within 24 hours in writing: of the presence or evolution of any disease listed in Annex III; 
and 
(c) without delay and in writing: of any significant changes in animal health status or of 
findings of epidemiological importance with respect to diseases other than those listed in 
Annex III; of changes in preventive policies, including vaccination policies; or, of any non-
routine measures taken to protect public health or to control or eradicate animal disease. 
2. Such notifications shall be made to the contact points set out in Annex IX. 
3. Where either Party has serious concerns regarding a risk to public or animal health, consultations 
regarding the situation shall, on request, take place as soon as possible, and in any case within 14 
days. Each Party shall endeavour in such situations to provide all the information necessary to avoid 
a disruption in trade, and to reach a mutually acceptable solution consistent with the protection of 
public or animal health. 
Article 12 
Safeguards 
Either Party may take provisional measures necessary for the protection of public or animal health. These 
measures shall be notified within 24 hours to the other Party, and, on request, consultations regarding the 
situation shall be held within 14 days. The Parties shall take due account of any information provided through 
such consultations, and shall endeavour to avoid unnecessary disruption to trade, taking advantage where 
possible of the provisions of Article 11.3. 
Article 13 
Outstanding Issues 
The principles of this Agreement shall also be applied to address outstanding issues listed in Annex VIII. 
Modifications shall be made to this Annex and, as appropriate, other Annexes, to take account of progress 
made and new issues identified. 
Article 14 
Joint Management Committee 
1. A Joint Management Committee (hereinafter referred to as 'the Committee'), consisting of 
representatives of the U.S. and the Community, is hereby established to guide the activities carried 
out under this Agreement. The Committee shall meet within one year of the entry into force of this 
Agreement and at least annually thereafter. The Committee may also address issues out of session 
by correspondence. 
2. The Committee shall, at least once a year, review the Annexes to this Agreement As appropriate, 
this review will take account of progress made on the continuing consultative process towards the 
recognition by the importing Party of the equivalence of sanitary measures maintained by the 
exporting Party and progress in completing the actions set out in Annex V. The Committee may 
recommend changes to the Annexes. 
3. The Parties agree to establish Technical Working Groups, consisting of expert-level representatives 
of the U.S. and the Community, which shall identify and address technical and scientific issues 
arising from this Agreement. 
When additional expertise is needed, the Parties may also establish ad hoc Technical Working 
Groups, notably scientific groups, whose membership need not be restricted to representatives of the 
Parties. 
10 
Article 15 
Territorial Application 
This Agreement shall apply, on the one hand, to the United States in respect of its entire territory, and, on the 
other hand, to the territories in which the Treaty establishing the European Community is applied and under 
the conditions laid down in that Treaty. 
Article 16 
Final Provisions 
1. This Agreement shall be approved by the Parties in accordance with their respective procedures. > 
This Agreement shall enter into force on the first day of the month following the date on which the 
Parties notify each other that the procedures mentioned in the preceding sub-paragraph have been 
completed. 
2. Each Party shall implement the commitments and obligations arising from this Agreement in 
accordance with its laws and procedures. Any changes to the annexes to this Agreement that are 
agreed by the Parties shall be implemented accordingly. 
3. Either Party may at any time propose modifications to this Agreement. Either Party may, upon 6 
months' notice withdraw from the Agreement. 
4. This Agreement shall be drawn up in two copies in the English language, each of these texts being 
equally authentic. 
For the Government of the For the European Community 
United States of A merica 
11 
LIST OF ANNEXES 
ANNEX I PRODUCT COVERAGE 
ANNEX II REGULATORY AUTHORITIES 
ANNEX III LIST OF DISEASES FOR WHICH REGIONAL FREEDOM IS RECOGNISED 
ANNEX IV ZONING AND RÉGIONALISATION 
ANNEX V RECOGNITION OF SANITARY MEASURES 
ANNEX VI GUIDELINES FOR CONDUCTING AN AUDIT 
ANNEX VII FRONTIER CHECKS 
ANNEX VIII OUTSTANDING ISSUES 
ANNEX IX CONTACT POINTS 
12 
ANNEX I 
PRODUCT COVERAGE 
Tariff Line General Description* 
01 Live animals 
02 Meat and edible meat offal 
03 Fish and crustaceans, molluscs and other aquatic invertebrates 
04 Dairy produce; birds' eggs; natural honey; edible products of animal origin not 
elsewhere specified or included 
05 Products of animal origin, not elsewhere specified or included, except for products 
of human origin 
15 01 Lard; other pig and poultry fat, rendered, 
15 02 Fats of bovine animals, sheep or goats, 
15 03 Lard stearin, lard oil, oleostearin, oleo-oil1 and tallow oil, 
15 04 Fats and oils and their fractions, of fish and marine mammals, 
15 05 Wool grease and fatty substances derived therefrom (including lanolin) 
15 06 Other animal fats and oils and their fractions, 
15 16 10 Animal fats and oils and their fractions, 
15 17 Margarine; edible mixtures or preparations of animal or vegetable fats or oils, 
except for such products consisting solely of vegetable fats or oils or their 
fractions 
15 18 Animal or vegetable fats and oils; inedible mixture or preparations of animal or 
vegetable fats or oils or of fractions of different fats or oils of Chapter 15, not 
elsewhere specified or included, except for such products consisting solely of 
vegetable fats or oils or their fractions 
15 22 Degras; residues resulting from the treatment of fatty substances or animal or 
vegetable waxes, except for such products consisting solely of material of non-
animal origin 
For definitive description, refer to Tariff Code 
16 Preparations of meat, of fish or of crustaceans, molluscs or other aquatic 
invertebrates 
17 02 10 Lactose and lactose syrup 
19 01 Malt extract; food preparations of flour, meal, starch or malt extract; food 
preparations of goods of heading Nos 0401 to 0404, not elsewhere specified or 
included; except for such products consisting solely of material of non-animal 
origin 
19 02 Pasta, whether or not cooked or stuffed (with meat or other substances) or 
otherwise prepared; couscous, whether or not prepared; except such products 
consisting solely of products of non-animal origin 
21 04 Soups and broths and preparations therefor; homogenized composite food 
preparations; except such products consisting solely of products of non-animal 
origin 
21 05 Ice cream and other edible ice, whether or not containing cocoa; except such 
products consisting solely of products of non-animal origin 
21 06 Food preparations not elsewhere specified or included; except such products 
consisting solely of products of non-animal origin 
23 01 Flours, meals and pellets, of meat or meat offal, offish or of crustaceans, molluscs 
or other aquatic invertebrates, unfit for human consumption; greaves; except such 
products consisting solely of products of non-animal origin 
23 09 Preparations of a kind used in animal feeding; except such products consisting 
solely of products of non-animal origin 
30 01 Glands and other organs for organo-therapeutic uses; heparin and its salts; other 
animal substances prepared for therapeutic or prophylactic uses; except such 
products of human origin; 
30 02 Animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera 
and other blood fractions; vaccines, toxins, cultures of micro-organisms 
(excluding yeasts) and similar products 
3101 Animal or vegetable fertilisers, except such products consisting solely of products 
of non-animal origin 
35 01 Casein, caseinates and other casein derivatives; casein glues 
35 02 Albumins, albuminates and other albumin derivatives 
35 03 Gelatin and gelatin derivatives; isinglass; other glues of animal origin, excluding 
casein glues of heading No 3501 
35 04 Peptones and their derivatives; other protein substances and their derivatives, not 
elsewhere specified or included; hide powder, whether or not chromed 
35 07 Enzymes; except such products consisting solely of products of non-animal origin 
14 
4101 Raw hides and skins of bovine or equine animals 
41 02 Raw skins of sheep or lambs 
41 03 Other raw hides or skins 
43 01 Raw furskins 
51 01 Wool 
51 02 Fine or coarse animal hair 
51 03 Waste of wool or of fine or coarse animal hair 
51 05 Wool and fine or coarse animal hair 
97 05 Collections and collectors' pieces of zoological interest 
15 
\M«ft< •"• 
ANNEX II 
A. U.S. REGULATORY AUTHORITY 
I. US Control Authority 
The federal agencies listed in this section are responsible for both domestically-produced and 
imported animals and animal products, unless otherwise noted. 
In relation to imports into the U.S., these agencies are responsible for: 
conducting frontier checks provided for in the Agreement; 
carrying out the consultations provided for under Article 7 of the Agreement; 
carrying out the verification procedures provided for in Article 9 of the Agreement; and 
carrying out the information exchange provided for in Article 10, the notifications provided 
for in Article 11, and the safeguards provided for in Article 12 of the Agreement. 
In relation to exports from the U.S., unless otherwise noted, these agencies are responsible for: 
controlling the circumstances of domestic production and processing; 
providing information concerning compliance with agreed upon regulatory requirements; 
providing agreed additional guarantees; 
carrying out the consultations provided for under Article 7 of this Agreement; 
carrying out the information exchange provided for in Article 10, the notifications provided 
for in Article 11, and the safeguards provided for in Article 12 of the Agreement. 
A. CONTROL OF ANIMAL HEALTH 
1. Animal Diseases/Pests 
a) Live animals (including apiculture bees), embryos, ova, semen and 
animal products - U.S. Department of Agriculture/Animal and Plant 
Health Inspection Service (USDA/APHIS) 
b) Imports of salmonid live fish, gametes and fertilized ova — Department 
of Interior/Fish and Wildlife Service (DOI/FWS) 
c) Imports of uneviscerated salmonid fish - DOI/FWS 
d) Animal Feed (including Pet Foods) 
1) Transmission of disease from feed - USDA/APHIS 
2) Adulteration, pesticides, chemical and microbial contamination, 
food additives, substances "generally recognised as safe" - Food 
and Drug Administration (FDA) 
16 
B. CONTROL OF PUBLIC HEALTH 
1. Meat and poultry for human consumption 
a) Fresh meat and products from domesticated, farmed and wild cattle, 
sheep, swine, goats and equine - U.S. Department of Agriculture/Food 
Safety and Inspection Service (USDA/FSIS)2 
b) Fresh meat and products from domestic and farmed chickens, turkeys, 
ducks, geese, and guinea fowl - USDA/FSIS-^ 
c) Fresh meat and products from wild and farmed game, with the exception 
of those from IB 1(a) and IB 1(b) above - (FDÀ) 
d) Fresh meat and products from species other than above - FDA 
e) Enforcing adulteration provisions of the law and limits for residues of 
drugs, pesticides, heavy metals, mycotoxins, and other contaminants in 
food 
1. Sampling of fresh meat and animal products and control of the 
fresh meat and products from domesticated, farmed and wild 
cattle, sheep, swine, goats, and equine, and for domesticated 
and farmed chickens (including liquid, frozen and dried egg 
products), turkeys, ducks, geese, and guinea fowl - USDA/FSIS 
2. Sampling of fresh meat and animal products (including animal 
feed) and control of the fresh meat and products of other species 
- FDA 
2. Eggs and Egg Products 
a) Shell eggs, hard-cooked eggs, ethnic egg delicacies, and imitation egg 
products - FDA 
b) Shell eggs (including cracks and dirties) for breaking for the production 
of liquid, frozen, and dried egg products (egg yolks, albumen, or any 
combination) - USDA/FSIS4 
3. Dairy 
a) All dairy products - FDA 
With very limited exceptions, USDA/FSIS has sole jurisdiction for these foods until the time they 
leave the slaughterhouse. After the meat and products have left the slaughterhouse, USDA/FSIS and 
FDA share jurisdiction. 
FDA is responsible for the approval of veterinary drugs and food additives in meat and poultry 
See preceding footnote 
FDA and FSIS share jurisdiction over these products after they have left the processing plant 
17 
4. Other Animal-Derived Foods (including Fish and Fishery Products^ 
a) All other animal-derived foods - FDA 
5. Animal Feed 
a) Adulteration, pesticides, chemical and microbial contamination, food 
additives, substances "generally recognised as safe" - FDA 
II. Competent Authorities for Voluntary Programs 
The federal agencies listed in this section are responsible for voluntary inspection and certification 
programs for domestically-produced animal product?. 
In relation to exports from the U.S., these agencies are responsible for: 
oversight of the circumstances of domestic production and processing for firms who 
participate in the voluntary program. 
providing information concerning compliance with agreed upon requirements for firms 
who participate in the voluntary program. 
providing agreed additional guarantees for firms who participate in the agreed program. 
A. ANIMAL HEALTH 
1. Non-salmonid fish and other non-mammalian aquatic animals, gametes and 
fertilised ova - USDA/APHIS, Department of Commerce/National Marine 
Fisheries Service (Commerce/NMFS) 
2. Salmonid live fish, gametes, and fertilised ova - USDA/APHIS, Commerce/NMFS 
3. Animal feed (including pet foods) containing fish and fishery products -
USDA/APHIS, Commerce/NMFS 
B. PUBLIC HEALTH 
1. Fresh meat and meat products^ from wild and farmed bison, ostrich, emu, rhea, 
rabbit, deer, partridge, and quail - USDA/FSIS 
2. Snakes for human consumption - Commerce/NMFS -
3. Shell eggs - USDA/AMS 
4. Cooked omelets made from egg products, diced eggs made from egg products -
USDA/FSIS 
5. Dairy - USDA/AMS 
6. Seafood (including live seafood) - Commerce/NMFS 
These meat products must be made from fresh meat slaughtered under the USDA/FSIS voluntary 
program. 
18 
III. Federal Agencies that Issue Certification 
This section lists the U.S. national agencies that issue export certificates agreed to by the EC and the US*>. The 
agency issuing certificates may be the control authority or another national agency that is recognised by the 
control authority for that purpose. More than one agency may issue certificates for a product. 
A. ANIMAL HEALTH 
CERTIFICATIONS 
1. Live animals (including apiculture bees), 
embryos, ova, semen, and products of animal origin 
2. Non-salmonid fish and other non-mammalian 
aquatic animals, gametes and fertilised ova 
3. Salmonid live fish, gametes, and fertilised ova 
4. Wild waterfowl 
5. Animal feed 
B. PUBLIC HEALTH 
CERTIFICATIONS 
1. Meat and poultrv for human 
consumption 
a) Fresh meat and products from 
domesticated, farmed and wild cattle, 
sheep, swine, goats, and equine, and 
domesticated and farmed chickens, 
turkeys, ducks, geese, and guinea 
fowl 
b) Snakes 
c) Fresh meat and products from 
species other than above DOC/ DOI/ USDA/ USDA/ USDA/ 
NMFS FWS FDA AMS APHIS FSIS 
!X 
X 
X X 
X X 
X 
X 
X 
X X 
X X 
X 
Note that the listing of a product in Section II does not mean that certificates will necessarily be 
required as part of agreements reached on equivalence. Such decisions will be made on a product-by­
product basis. 
19 
Public health certifications cont'd 
2. Eggs 
a) Shell eggs,, hard cooked eggs, 
ethnic egg delicacies, and imitation 
egg products 
b) Liquid, frozen and dried egg 
products 
3. Dairv 
a) Butter, cheese, frozen desserts, and 
dried milk products 
b) Fluid milk 
4. Seafood 
a) Fish and fishery products including 
fish oil, reptiles (except snakes), snails 
and amphibians 
b) Live fish (including shellfish and 
molluscs) DOC/ DOI/ USDA/ USDA/ USDA/ 
NMFS FWS FDA AMS APHIS FSIS 
X X 
X 
X 
X X 
X 
X X 
X 
B. EUROPEAN COMMUNITY 
Control is shared between the national services in the individual Member States and the European 
Commission. In this respect the following applies: 
In terms of exports to the U.S., the Member States are responsible for control of the 
production circumstances and requirements, including statutory inspections, and issuing 
health certification attesting to the agreed standards and requirements. 
The European Commission is responsible for overall co-ordination, inspections/audits of 
inspection systems and the necessary legislative action to ensure uniform application of 
standards and requirements within the Single European Market. 
20 
ANNEX III 
LIST OF DISEASES FOR WHICH REGIONAL FREEDOM IS RECOGNISED 
Animal diseases 
Foot and mouth disease 
Swine vesicular disease 
Peste de petits ruminants 
Contagious caprine pleuropneumonia 
Sheep and goat pox 
African swine fever 
Enterovirus encephalomyelitis 
Newcastle Disease 
Pseudorabies/Aujeszky's Vesicular stomatitis 
Rinderpest 
Contagious bovine pleuropneumonia 
Bluetongue 
African horse sickness 
Classical swine fever 
Fowl plague (avian influenza) 
Venezuelan Equine Encephalomeyelitis 
Aquaculture diseases 
The list of aquaculture diseases is to be discussed further by the Parties on the basis of the 
International Aquatic Animal Health Code of the OIE 
21 
ANNEX IV 
ZONING AND REGIONALISATION 
The Parties have jointly determined that the following forms the basis for Régionalisation decisions for the 
diseases listed in accordance with Annex III. Each Party will recognise régionalisation decisions taken in 
accordance with the standard contained within this Annex. 
Animal Diseases 
In assessing risk from a given proposed importation of animals or animal products, three sets of factors may 
be considered: 
1. Source risk factors. 
2. Commodity risk factors. 
3. Destination risk factors. 
Source Risk Factors 
The primary determinant of the risk of importing disease is the status of the country of origin in respect of the 
disease in question. However, declarations of disease freedom must be backed up by effective surveillance 
programmes. 
The over-riding consideration in this context, therefore, is the quality of the veterinary infrastructure. No 
other factors can be assessed without full confidence in the veterinary administration. In particular, its ability 
to detect and control an outbreak of disease and to provide meaningful certification is crucial. 
The ability to detect the presence of disease depends on the surveillance carried out. This surveillance can be 
active, passive, or both. 
Active surveillance implies definitive action intended to identify the presence of disease, such as systematic 
clinical inspections, ante and post mortem examination, serology on farm or in abattoir, referral of 
pathological material for laboratory diagnosis, sentinel animals. 
Passive surveillance means that the disease must-be compulsorily notifiable and that there must be a 
sufficiently high level of supervision of the animals in order to ensure mat the disease will be observed 
quickly and reported as a suspect. There must also be a mechanism for investigation and confirmation, and a 
high level of awareness of the disease and its symptoms by farmers and veterinarians. 
22 
Epidemio-surveillance may be augmented by voluntary and compulsory herd/flock health programmes, 
particularly those which ensure a regular veterinary presence on the farm. 
Other factors to be considered include: 
disease history 
vaccination history 
controls on movements into the zone, out of the zone and within the zone 
animal identification and recording 
presence of disease in adjacent areas 
physical barriers between zones of differing status 
meteorological conditions 
use of buffer zones (with or without vaccination) 
presence of vectors and/or reservoirs 
active control and eradication programmes (where appropriate) 
ante and post mortem inspection. 
On the basis of these factors, a zone, may be defined. 
The authority with the responsibility for implementing the zoning policy is in the best position to define and 
maintain the zone. When there is a high level of confidence in that authority, the decisions it makes can be the 
basis for trade. 
The zones so defined may be assigned a risk category. 
Possible categories are: 
low/negligible risk 
medium risk 
high risk 
unknown risk. 
Calculation of estimates of risk for e.g. live animals may assist in this categorisation. Import conditions may 
then be defined for each category, disease and commodity, individually or in groups. 
Low/negligible risk implies that importation may take place based on a simple guarantee of origin. 
Medium risk implies that some combination of certification and/or guarantees may be required before or after 
importation. 
High risk implies that importation will only take place under conditions which significantly reduce the risk, 
e.g. by additional guarantees, testing or treatment. 
Unknown risk implies that importation will only take place if the commodity itself is of very low risk, e.g. 
hides, wool, or under the conditions for "high risk" if the commodity factors warrant. 
Commodity Risk Factors 
These include: 
is the disease transmissible by the commodity? 
could the agent be present in the commodity if derived from a healthy and/or clinically 
affected animal? 
can the preceding factor be reduced, e.g. by vaccination? 
what is the likelihood that the commodity has been exposed to infection? 
has the commodity been obtained in such a way as to reduce the risk, e.g. deboning? 
- has the commodity been subjected to a treatment which inactivates the agent? . 
Appropriate tests and quarantine will reduce the risk. 
Destination Risk Factors 
presence of susceptible animals 
presence of vectors , 
possible vector-free period 
preventative measures such as waste food feeding and animal waste rendering rules 
intended use of product e.g. petfood, human consumption only. 
These factors are inherent in or are under the control of the importing country, and some may therefore be 
modified to facilitate trade. These may, for example, include restricted entry conditions e.g. animals to be 
confined to a certain vector free region until the incubation period has passed, or canalisation systems. 
However, destination risk factors will also be taken into account by the infected country with respect to the 
risk presented by movements from the infected part to the free part of its territory. 
Aquaculture Diseases 
Pending the development of any specific provisions to be included in this Annex, the basis for Régionalisation 
decisions for aquaculture diseases will be the International Aquatic Animal Health Code of the OIE. 
24 
ANNEX V 
SANITARY MEASURES RECOGNISED AS EQUIVALENT 
The following glossary applies to the attached Annex V: 
Yes (1) The importing Party agrees that the exporting Party's measures achieve the- importing Party's 
appropriate level of sanitary protection 
Yes (2) The importing Party agrees that the exporting Party's measures, with the special conditions set out, 
achieve the importing Party's appropriate level of sanitary protection 
Yes (3) Equivalence agreed in principle, subject to satisfactory completion of the actions. Pending 
completion, trade shall occur on the basis of the special conditions set out 
NE Not evaluated. Trade shall occur on the basis of compliance with the importing Party's requirements. 
E . Still evaluating. Trade shall occur on the basis of compliance with the importing Party's 
requirements. 
AI Avian Influenza 
ASF African Swine Fever 
BSE Bovine Spongiform Encephalopathy 
CEM Contagious Equine Metritis 
CFR Code of Federal Regulations 
CSF Classical Swine Fever (Hog Cholera) 
EBL Enzootic Bovine Leucosis 
EC European Community 
EPIA Egg Products Inspection Act 
FFDCA Federal Food, Drug and Cosmetic Act 
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act 
FMD Foot and Mouth Disease 
IBR Infectious Bovine Rhinotracheitis 
ND Newcastle Disease 
OIE Organisation International des Epizooties 
PHSA Public Health Service Act 
PM Post Mortem 
ScVC Scientific Veterinary Committee 
SVD Swine Vesicular Disease 
TB Bovine Tuberculosis 
TME Transmissible Mink Encephalopathy 
TSE Transmissible Spongiform Encephalopathy 
U.S. United States of America 
WTO World Trade Organisation 
25 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community | 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
1. Live animals 
Animal health 
- Equidae 90/426 Annex 
DandC 9 CFR 92 EC to submit by 1 July 
1997, for each EC 
laboratory the testing 
procedures, antigens/ 
reagents used, audit/quality 
control program, external 
control/laboratory approval 
programme. 
Inter-laboratory reference 
testing and exchange of 
samples between designated 
EC and U.S laboratories for 
CEM, glanders, dourine, 
piroplasmosis, equine 
infectious anaemia and 
equine viral arteritis to be 
carried out by 1 July 1997. 
U.S. to consider, by 1 
September 1997, 
withdrawing requirement for 
post-import quarantine on 
the bases of results. 
U.S. to assess EC request on 
disease status for dourine 
and glanders within 3 
months of EC submission. 
U.S. to review their CEM 
and piroplasmosis 
requirements by 1 January 
1998. 9 CFR 71, 
75,91 90/426, 92/260, 
93/195, 93/196, 
93/197,94/467 U.S. to consider identifying 
horses by passport from 
31.12.1997. 
EC to consider withdrawing 
requirement for isolation 
before departure for 
permanent imports within 6 
months of the submission of I 
the final report on VS 
outbreak -
26 
Commodity 
Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions 
I. Live animals (cont.) animal health j 
- Bovine 
Animals 
- Shccp/Goats 
• Swine 
- Dogs and cats 
• "Balai" 
animals 64/432, 72/462, 
90/425 
91/68 
64/432, 72/462, 
90/425 
92/65 
92/65 9 CFR 92 
9 CFR 92 
9 CFR 92 
9 CFR 92 
9 CFR 92 E 
E 
E 
NE 
NE U.S. to review BSE policy 
with respect to high and low 
incidence. 
U.S. to produce generic 
conditions for EC 
U.S. to produce generic 
conditions for EC 
U.S. to produce generic 
conditions for EC 9 CFR 71, 72, 
73, 77, 78, 80 
91 
9 CFR 54, 71, 
79,77 
9 CFR 71, 76, 
77,78, 85 72/462 
91/68,97/231 
72/462 
92/65 
92/65 E 
E 
E 
NE 
NE -EC to review U.S. dossier on I 
bluetongue 1 
U.S. to provide details ofj 
RB51 brucellosis vaccine, fori 
review by EC fl 
EC to produce conditions fori 
U.S. 1 
EC to review U.S. dossier onl 
bluetongue | 
U.S. to submit scrapie! 
programme when final | 
review is completed. EC to J 
comment 1 
EC to produce conditions fori 
U.S. | 
EC to produce conditions fori 
U.S. 
—j——————-——— 
i 
27 
- Commodity 
- Species 
Animal/Public 
health 
'' • — European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community f 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions I 
2. Live poultry and hatching eggs 
Animal health 
90/539, 93/342 9 CFR 92 U.S. to produce generic 
conditions 9 CFR 71, 82, 
145, 147 90/539, 93/432 
96/482,96/483 
3. Semen | 
Animal health 
- Bovine 
- Sheep/Goats 
• Porcine 
- Canine 
- Feline. 88/407 
92/65 
90/429 
92/65 
92/65 9CFR98 
9CFR98 
9CFR98 
9CFR 98 E 
E 
E 
NE 
NE U.S. to produce generic 
conditions for EC 
U.S. to produce generic 
conditions for EC 
U.S. to produce generic 
conditions for EC 9CFR 
71,77,78 
9 CFR 71,79 
9 CFR 71, 78, 
85 88/407,94/577 
Directive 92/65 
90/429,93/199 
92/65 
92/65 E 
NE 
E 
NE 
NE EC to produce conditions to 
allow use of new elisa test kill 
for bluetongue | 
EC to consider allowing | 
movement between centres I 
in two approved third | 
countries | 
EC to examine U.S. request! 
that CSF tests not be required I 
on entry and exit from! 
centres in countries free ofl 
the disease. 
• 
, 
28 
- Commodity 
- Species 
Animai/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
|U. Equine semen, ova and embryos 
Animal health 
Semen 92/65, 95/307 9 CFR 98 NE 9 CFR 71, 75 92/65,96/539 NE 3 
29 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actjons 
4. Equine semen, ova and embryos - animal health - cont'd 
- Ova 
- I-mbryos 92/65,95/294 
92/65, 95/294 9 CFR 98 
9 CFR 98 NE 
NE 9 CFR 71,75 
9 CFR 71, 75 92/65,96/540 
92/65,96/540 NE 
NE 
5. Embrvos 
Animal health 
- Bovine 
-Ovine/Caprine 89/556 
92/65 9 CFR 98 
9 CFR 98 E 
NE -: U.S. to produce generic 
conditions for EC. 
U.S. to review suspension of 
imports from BSE affected 
countries 9 CFR 71, 77, 
78 89/556,92/471 
92/65 E 
NE 
| 
30 
Commodity 
Species 
Animal/Public European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
6. Fresh meat 
Animal health 
-Ruminants 
•IZquidae 
-Porcine 64/432, 72/461, 
72/462 
64/432, 72/461, 
72/462 
64/432, 72/461, 
72/462 9 CFR 94 
9 CFR 94 
9 CFR 94 Yes 2 
Yesl 
Yesl Additional certification for 
bovines from BSE affected 
countries 
. • U.S. to review rules on BSE 
with respect to high/low 
incidence regions 9 CFR 53 (in 
the case of an 
outbreak of 
exotic disease) 
9 CFR 53 
9 CFR 53 72/462, 82/426 
72/462, 82/426 
72/462, 82/426 Yes 2 
Yes 2 
Yes 2 • 
3 month residence. 
Holding freedom from 
brucellosis for ovines and 
caprines 
3 month residence 
3 month residence. 
Holding freedom from 
brucellosis | 
31 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
6. Fresh meat cont'd 
'ublic health 
Ruminants 
Equidae 
Porcine 
Ovine 
Caprine (8) 64/433, 96/22 9 CFR 301-381, 
416,417 Yes 3 Establishments listed in 
accordance with footnote (7), 
and fulfilling the relevant 
provisions of footnote (1). Equivalency (Yes 2) shall be 
granted after the U.S. has 
completed verification of 
veterinary delivery systems. 
This process shall be 
completed within 12 months 
of the date of entry into force 
of the agreement. 9 CFR 301-381, 
416,417 72/462, 93/158, 
96/22 Yes 3 Establishments listed in 
accordance with footnote (7), 
and fulfilling the relevant 
provisions of footnotes (2), 
(3) (4) and (5). The EC shall evaluate the 
U.S. residue programme, and 
additional information to be 
submitted by the U.S., to 
determine whether it meets 
the EC level of protection. 
This evaluation shall be 
completed within 6 months 
of the entiy into force of this 
Agreement 
he I 
to The EC shall evaluate the 
U.S. water standards 
determine whether they meet 
the EC level of protection. 
This evaluation shall be 
completed within 6 months 
of the entry into force of this 
Agreement 
The EC to evaluate a U.S.I 
request, when submitted, onl 
the need for continued! 
trichinae testing of| 
horsemcat. ' 
32 
-Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
FX Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
-j 
6. Fresh meat - public health - cont'd 
Re footnote 5 (e), the results 
of the inspections after 
incision of pig hearts shall be 
jointly evaluated after 12 
months, with a view to 
determining if modifications 
should be made to the 
provisions of footnote 5(e). 
Equivalency (Yes 2) shall be 
granted after the EC has 
completed verification of the 
application of the specified 
conditions. This process shall 
be completed within 12 
months of the entry into force 
of the agreement 
7. Poultry meat 
Animal health 
Public health 91/494,94/438 
71/118, 96/22, 
96/23 9 CFR 94 
9 CFR 381 Yesl 
Yes 3 Establishments listed in 
accordance with footnote (7), 
and fulfilling the relevant 
provisions of footnote (1). 
Post-mortem inspection to be 
carried out by official 
inspectors Equivalency (Yes 2) shall be 
granted after the U.S. has 
completed verification of 
veterinary delivery systems. 
This process shall be 
completed within 12 months 
of the date of entry into force 
of the agreement. 9 CFR 53 
9 CFR 381.1 
381.5 91/494,93/342 
94/984 
71/118, 96/22, 
96/23,96/712 Yesl 
Yes 3 Establishments listed in 
accordance with footnote (7), 
and fulfilling the relevant 
provisions of footnotes (2), 
(3), (4) and (6). The EC shall evaluate the 
U.S. residue programme, and 
additional information to be 
submitted by the U.S., to 
determine whether it meets 
the EC level of protection. 
This evaluation shall be 
completed within 6 months 
of the entry into force of this 
Agreement ' 
33 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
FX Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
7. Poultry meat - public health - cont'd 
The EC shall evaluate the 
U.S. water standards to 
determine whether they meet 
the EC level of protection. 
This evaluation shall be 
completed within 6 months 
of the entry into force of this 
Agreement. 
The EC shall carry out a 
scientific review of the use of 
antimicrobial techniques, and 
in particular the use of TSP 
and/ or organic acids, with 
full participation of U.S. 
scientists. The scientific 
review should be completed 
as soon as possible,. 
Equivalency (Yes 2) shall be 
granted after the EC has 
completed verification of the 
application of the specified 
conditions. This process shall 
be completed within 12 
months of the entry into force 
of the agreement. 
34 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions I 
| 
8. Meat Products 
Animal health 
• Red Meat 
(ruminants/ 
equidae) 64/432, 72/461, 
72/462, 80/215 9 CFR 94 Yes 2 Additional certification for 
bovines from BSE affected 
countries U.S. to review rules on BSE 
with respect to high/low 
incidence regions 9 CFR 53 72/462,97/221 Yes 2 Derived from meat meeting 
the conditions of point 6 
(fresh meat). 
Pies. 
Poultry 
• Wild game 
and fanned 
eame 64/432, 72/461, 
72/462,80/215 9 CFR 94 Yesl 9 CFR 53 72/462,97/221 Yes 2 Derived from meat meeting 
the conditions of point 6 
(fresh meat). 
92/118, 72/462, 
80/215,94/438 9 CFR 94 Yesl 9 CFR 53 97/221 Yes 2 
92/495, 92/45 9 CFR 94 Derived from meat meeting 
the conditions of point 7 
(poultrymeat). 
Yes 2 Additional certification for 
bovines from BSE affected 
countries U.S. to review rules on BSE 
with respect to high/low 
incidence regions 92/495,92/45 
97/221 NE 
35 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
FC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
8. Meat Products cont'd 
Public health 
Ruminants w 
Equidae 
Pigs \ 
Poultry 77/99, 96/22 CFR 301-335, 
354, 381.1-
381.500 Yes 3 Establishments listed in 
accordance with footnote (7), 
and fulfilling the relevant 
provisions of footnote 1. Equivalency (Yes 2)shall be 
granted after the U.S. has 
completed verification of 
veterinary delivery systems. 
This process shall be 
completed within 12 months 
of the date of entry into force 
of the agreement. 9 CFR 301-335, 
354, 381.1-
381.500 72/462, 77/99, 
92/118,96/22 Yes 3 Derived from meat meeting 
the conditions of point 6 
(fresh meat) and/or 7 
(poultrymeat). 
Establishments listed in 
accordance with footnote (7), 
and fulfilling the relevant 
provisions of footnotes (2), 
(3) and (4). The EC shall evaluate the 
U.S. residue programme, and 
additional information to be 
submitted by the U.S., to 
determine whether it meets 
the EC level of protection. 
This evaluation shall be 
completed within 6 months 
of the entry into force of this 
Agreement. 
The EC shall evaluate the 
U.S. water standards to 
determine whether they meet 
the EC level of protection. 
This evaluation shall be 
completed within 6 months 
of the entry into force of this 
Agreement. 
Equivalency shall be granted 
after the EC has completed 
verification of the application 
of the specified conditions. 
This process shall be 
completed within 12 months 
of the entry into forpe of the 
agreement. 
36 
- Commodity 
- S pee les . 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community I 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
8. Meat Products - public health - cont'd 
Wild came W 
Farmed came (8) 77/99, 96/22 FFDCA, 
FIFRA, PHSA 
21 CFR 70-82, 
101, 109, 
110.3-110.93, 
113, 114, 170-
189, 510-529, 
556 
40 CFR 180, 
185 NE Existing trade conditions FFDCA, 
FIFRA, PHSA 
21 CFR 70-82, 
101, 109, 
110.3-110.93, 
113, 114, 170-
189, 510-529, 
556 
40 CFR 180, 
185 77/99, 92/118, 
96/22 NE 
9. Farmed game meat 1 
Animal health 
-Deer 
-Rabbit 
-Porcine 
-Feathered 72/461, 92/118, 
91/495 
72/461, 92/118, 
91/495 
92/118, 72/462, 
80/215,94/438 9 CFR 94 
9 CFR 94 
9 CFR 94 Yes 2 
Yesl 
Yesl 
Yesl Additional certification from 
BSE affected countries U.S. to review rules on BSE 
with respect to high/low 
incidence regions 
9 CFR 94 92/118,91/495 
97/219 
92/118 
92/118,97/219 NE 
NE 
NE J 
37 
• Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
F.C Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
9. Farmed game meat cont'd 
Public health 
See footnote (8) 
for ruminants 91/495, 96/22, 
97/219 FFDCA, 
FIFRA, PHSA 
21 CFR 70-82, 
101, 109, 
110.3-110.93, 
113, 170-189, 
510-529,556 
40 CFR 180, 
185 
9 CFR 301-335, 
352,354 NE Existing trade conditions FFDCA, 
FIFRA, PHSA 
21 CFR 70-82, 
101, 109, 
110.3-110.93, 
113, 170-189, 
510-529,556 
40 CFR 180, 
185 
9 CFR 301-335, 
352,354 91/495, 96/22, 
97/219 NE 
10. Wild game meat ] 
Animal health 
-Deer 
-Rabbit 
-Porcine 92/45 
92/45 9 CFR 94 
9 CFR 94 E 
E • 
, 92/45,97/218 
92/45,97/220 NE 
NE 
, 
38 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions ' ' •' United States Exports to the European Community 
i Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
10. Wild game meat - animal health - cont'd 
-Feathered 
Public health 
See footnote (8) 
for ruminants 92/45 
92/45, 96/22, 
96/23, 97/218, 
97/220 9 CFR 94 
FFDCA, 
FIFRA, PHSA 
21 CFR 70-82, 
101, 109, 
110.3-110.93, 
170-189, 510-
529,556 
9 CFR 301-335 
40 CFR 180, 
185 £ 
NE Existing trade conditions FFDCA, 
FIFRA, PHSA 
21 CFR 70-82, 
101, 109, 
110.3-110.93, 
170-189, 510-
529, 556 
9 CFR 301-335 
40 CFR 180, 
185 92/45,97/218 
92/45, 96/22, 
96/23, 97/218, 
97/220 NE 
NE 
39 
Commodity 
Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards l U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
11. Fisheries products for human consumption 
Animal health 
-Fish/fisheries 
products 
-Bivalve 
molluscs/ 
crustaceans 
(excl. live) 
Public health 
-Fish/fisheries 
products 91/67 
91/67 
91/493, 96/22, 
96/23 USDI & Title 
50 
USDI & Title 
50 
21 CFR 123, 
1240 NE 
NE 
Yes 3 Low Acid Canned Food 
requirement U.S. to respond, by 1 July 
1997, with detailed 
indication of how the EC 
request for equivalence for 
Low Acid Canned Food can 
be considered. 
By May 15, EC to provide 
(1) appropriate information 
and documentation on 
procedures for audit and 
control of implementation 
by Member States, and (2) 
information on application 
of HACCP systems in 
Member States. USDI & Title 
50 
USDI & Title 
50 
21 CFR 123, 
1240 91/67 
91/67 
91/493, 95/328, 
96/22,96/23 NE 
NE 
Yes 3 95/328 EC to evaluate new U.S. 
standards if applicable 
U.S. to inform the EC when 
the U.S. is ready to have the 
implementation of its 
seafood HACCP Regulation 
reviewed. 
EC to carry out review, 
involving as necessary 
examination of information 
and documentation to be 
provided by U.S. on 
procedures for audit and 
control of implementation. 
On-site verification of U.S. 
system to be carried out 
within 6 months of U.S. 
request. ' 
40 
- Commodity 
- .Species 
Animal/Public 
1 health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 1 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 1 
~l 
11. Fisheries products for human consumption - Public Health - cont'd 
- Fisli/fisheries 
products cont'd Before 1 September 1997, 
U.S. to conduct on-site 
verification of EC system 
(including visit to EC 
central offices and 
observation of Commission 
audits of a number of 
Member States). 
U.S. to indicate any 
outstanding problems 
following above actions by 
15 October 1997. 
The outcome of the on-site 
verification to be discussed 
with EC. If on-site 
verification satisfactory, the 
equivalence determination 
to be finalised, and any 
necessary procedures carried 
out. NMFS 
Voluntary 
HACCP based 
Program 50 
CFR 260 Yesl EC to indicate any 
outstanding problems 
following above actions 
within 45 days of on-site 
verification. 
The outcome of the on-site 
verification to be discussed 
with EC. If on-site 
verification satisfactory, the 
equivalence determination 
to be finalised, and any 
necessary procedures carried 
out. 
"Establishments" do not 
include "brokers or traders". 
41 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions — 1 
United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
11. Fisheries products for human consumption - Public Health - cont'd 
-Bivalve 
molluscs/ 
crustaceans 
excl. live) 91/492, National 
Shellfish 
Sanitation 
Programme Yes 3 I Existing trade conditions EC to supply the raw data 
used for the scientific 
assessment on flesh/water 
testing. U.S. shall respond to 
results of scientific 
assessment within 90 days of 
receipts of raw data. 
By May 15, EC to provide 
(1) appropriate information 
and documentation 'on 
procedures for audit and 
control of implementation 
by Member States, and (2) 
information on application 
of HACCP systems in 
Member States. 
Before 1 September 1997, 
U.S. to conduct on-sitt 
verification of EC system 
(including visit to EC 
central offices and 
observation of Commission 
audits of a number of 
Member States). 
U.S. to indicate any 
outstanding problems 
following above actions by 
15 October 1997. National 
Shellfish 
Sanitation 
Programme 91/492 Yes 3 Existing trade conditions Joint comparison of 
flesh/water testing for 
classification of production 
areas. 
U.S.. to inform the EC when 
the U.S. is ready to have the 
implementation of its 
seafood HACCP Regulation, 
reviewed. 
EC to carry out review, 
involving as necessary 
examination of information 
and documentation to be 
provided by U.S. on 
procedures for audit and 
control of implementation. 
On-site verification of U.S. 
system to be carried out 
within 6 months of U.S. 
request. 
EC to indicate any 
outstanding problems 
following above ' actions 
within 45 days of on-site 
verification. 
42 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions Umted States Exports to the European Community 1 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
===== 
11. Fisheries products for human consumption - Public Health - cont'd 
-Bivalve 
molluscs/ 
crustaceans 
(excl. Live) 
cont'd 
- Aquaculture 
animals and 
products 91/493, 96/22, 
96/23 National 
Shellfish 
Sanitation 
Programme, 
FFDCA, 
FIFRA, PHSA, 
21 CFR 110.3-
110.93, 123, 
1240, DVM NE The outcome of the on-site 
verification to be discussed 
with EC. If on-site 
verification satisfactory, the 
equivalence determination 
to be finalised, and any 
necessary procedures carried 
out. 
National 
Shellfish 
Sanitation 
Programme, 
FFDCA, 
FIFRA, PHSA, 
21 CFR 110.3-
110.93, 123, 
1240, DVM 91/493, 96/22, 
96/23 NE The outcome of the on-site 
verification to be discussed 
with EC. If on-site 
verification satisfactory, the 
equivalence determination 
to be finalised, and any 
necessary procedures carried 
out. 
"Establishments" do not 
include "brokers or traders". 
12. Live fish / shellfish and gametes 
Animal health 91/67 NE 91/67 NE 
43 
- Commodity 
- Species 
Animal/Public 
health European Commumty Exports to the United States 
Trade Conditions 
IZC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
113. Milk and milk based products for human consumption 
Animal health 
-Cattle 
including 
buffalo 
-Sheep 
-Goats 
i 64/432, 92/46 9 CFR 94 Yes 2 Certification to UHT for 
FMD affected regions 
For non-FMD affected 
countries/regions a certificate 
of origin is required. U.S. to review whether 
double pasteurisation 
acceptable. 
t 9 CFR 77,78 92/46,95/343 Yes 2 TB and Brucella 
requirements for non-heat 
treated EC to review U.S. TB and 
Brucella programmes 
44 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Commumty 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
3. Milk and milk based products for human consumption cont'd 
'ubiic health 
EC requirements for somatic 
cell and plate counts 
Certification as per 95/343 •UHT-Milk/ 
sterilised 
Milk 92/46, 94/71, 
95/340, 95/342, 
96/22, 96/23, 
97/115, 91/180, 
92/608, 92/118, 
96/90 FFDCA,FIFRA, 
PHSA 21 CFR 
70-82, 108, 
110.3-110.93, 
113, 131, 172, 
184, 510-520, 
556, 1210, 
1240 
40 CFR 180, 
185 Yes 3 Existing trade conditions. U.S. to review Import Milk 
Act. 
U.S. to respond, by 1 July 
1997, with detailed indication 
of how the EC request for 
equivalence for Low Acid 
Canned Food can be 
considered. 
Joint assessment of 
laboratories to be completed 
EC to provide appropriate 
information and 
documentation on 
procedures for audit and 
control of implementation 
by Member States. U.S. to 
review information 
provided, and to carry out 
on-site verification of EC 
system. FFDCA, 
FIFRA, PHSA 
21 CFR 70-82, 
108, 110.3-
110.93, 113, 
131, 172, 184, 
510-520, 556, 
1210,1240 
40 CFR 180, 
185 92/46, 94/71, 
95/340, 95/342, 
95/343, 96/22, 
96723, 97/115, 
91/180, 92/608, 
92/118,96/90 Yes 3 U.S. to consider including 
HACCP system in dairy 
products 
Joint assessment of 
laboratories to be completed 
Discussions on somatic cells 
and plate counts to continue 
U.S. to provide appropriate 
information and 
documentation on 
procedures for audit and 
control of implementation. 
EC to review information 
provided, and to cany out 
on-site verification of U.S. 
system. 
The outcome of the on-site 
verification to be discussed 
with U.S.. If on-site 
verification satisfactory, the 
equivalence determination 
to be finalised, and any 
necessary procedures carried 
out 
45 
1 
j-Commodity 
-Species 
i- Animal/Public 
! health 
l . European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
3. Milk and milk based products for human consumption - public health - cont'd 
•UHT-Miik/ 
sterilised 
Milk cont'd 
Pasteurised 
Milk Ordinance 
for Grade A 
Products and 
related 
documents The outcome of the on-site 
verification to be discussed 
with EC. If on-site 
verification satisfactory, the 
equivalence determination 
to be finalised, and any 
necessary procedures carried 
out. 
The U.S. to respond, by 1 
July 1997, with a detailed 
indication of how the EC 
request for equivalence to 
"Grade A" can be 
considered, and thus to 
allow the possibility of 
export of such products to 
the U.S.. Pasteurised 
Milk Ordinance 
for Grade A 
Products and 
related 
documents 
-Pasteurised 
products 92/46, 94/71, 
95/340, 95/342, 
96/22, 96/23, 
97/115, 91/180, 
92/608, 92/118, 
96/90 FFDCA, 
FIFRA, PHSA 
21 CFR 70-82, 
.108, 110.3-
110.93, 113, 
131, 133, 135, 
172, 184, 510-
520, 556, 
1210,1240 
40 CFR 180, 
185 Yes 3 Existing trade conditions 
E coli requirement (for 
cheeses) V.S. to review Import Milk 
Act. 
Discussions on differences in 
finished product criteria for E 
coli to continue. 
Joint assessment of 
laboratories to be completed FFDCA, 
FIFRA, PHSA 
21 CFR 70-82, 
108, 110.3-
110.93, 113, 
131, 133, 135, 
172, 184, 510-
520, 556, 
1210,1240 
40 CFR 180, 
185. 92/46, 94/71, 
95/340, 95/342, 
95/343, 96/22, 
96/23, 97/115, 
91/180, 92/608, 
92/118,96/90 Yes 3 EC requirements for somatic 
cell and plate counts 
Certification as per 95/343 U.S. to consider including 
HACCP system in dairy 
products 
Joint assessment of 
laboratories to be completed 
Discussions on somatic cells 
and plate counts to continue 
U.S. to provide appropriate 
information , and 
documentation on 
procedures for audit and 
control of implementation 
46 
- Commodity 
- Species 
Animal/Public 
health European Commumty Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 1 
, Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
13. Milk and milk based products for human consumption - public health - cont'd 
-Pasteurised 
products cont'd 
Pasteurised 
Milk Ordinance 
for Grade A 
Products and 
related 
documents EC to provide appropriate 
information and 
documentation on 
procedures for audit and 
control of implementation 
by Member States 
U.S. to review information 
provided, and to carry out 
on-site verification of EC 
system. 
The outcome of the on-site 
verification to be discussed 
with EC. If on-site 
verification satisfactory, the 
equivalence determination 
to be finalised, and any 
necessary procedures carried 
out 
The U.S. to respond, by 1 
July 1997, with a detailed 
indication of how the EC 
request for equivalence to 
"Grade A" can be 
considered, and thus to 
allow the possibility of 
export of such products to 
the U.S.. Pasteurised 
Milk Ordinance 
for Grade A 
Products and 
related 
documents EC to review information 
provided, and to cany out 
on-site verification of U.S. 
system. 
The outcome of the on-site 
verification to be discussed 
with U.S.. If on-site 
verification satisfactory, the 
equivalence determination 
to be finalised, and any 
necessary procedures carried 
out 
47 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions , u 
United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
13. Milk and milk based products for human consumption - public health - cont'd 
Compliance with EC 
requirements for somatic celt 
and plate counts 
Certification as per 95/343 TTS^oconsiaePTncluding J 
HACCP system in dairy | 
products. 
Joint assessment of 
laboratories to be completed. 
Discussions on somatic cells 
and plate counts to continue. 
U.S. to provide appropriate 
information and 
documentation on 
procedures for audit and 
control of 
implementation.EC to 
review information 
provided, and to carry out 
on-site verification of U.S. 
system. 
The outcome of the on-site 
verification to be discussed 
with VS.. If on-site 
verification satisfactory, the 
equivalence determination 
to be finalised, and any 
necessary procedures carried 
out -Not 
Pasteurised 
(raw or 
thermiscd) 91756;—547717 
95/340, 95/342, 
97/115, 91/180, 
92/608, 92/118, 
96/22, 96/23, 
96/90 WUCK, 
FIFRA, PHSA 
21 CFR 70-82, 
108, 110, 113, 
133, 172, 184, 
185, 510-520, 
556, 1240 
40 CFR 180 YêsT Compliance with E coli 
requirement (for cheeses) 
Prohibition on products not 
matured for more than 60 
days at temperature above 
35°F (+2°C). Discussions on ditterences in 
finished product criteria for E 
coli to continue. 
Joint assessment of 
laboratories to be completed 
EC to provide appropriate 
information and 
documentation on 
procedures for audit and 
control of implementation 
by Member States. 
U.S. to review information 
provided, and to carry out 
on-site verification of EC 
system. The outcome of the 
on-site verification to be 
discussed with EC. If on-site 
verification satisfactory, the 
equivalence determination 
to be finalised, and any 
necessary procedures carried 
out. 
The U.S. to consider a 
dossier, to be submitted by 
the EC, for cheese not 
matured for more than 60 
days, and thus to allow the 
possibility of export of such 
products to the U.S.. FFDCA, 
FIFRA, PHSA 
21 CFR 70*82, 
108, 110, 113, 
133, 172, 184, 
185, 510-520, 
556,1240 
40 CFR 180 92/46, 94/71, 
95/340, 95/342, 
95/343, 97/115, 
91/180, 92/608, 
92/118, 96/22, 
96/23, 96/90 YêsT 
•J 
48 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 1 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions | 
14. Milk and milk based products not for human consumption | 
Animal health 
-Cattle 
including 
buffalo 
-Sheep 
-Goats 
All- pasteurised 
or UHT or 
Sterilised 
-Unpasteurised 
colostrum for 
pharmaceu­
tical use (l0) 92/118,64/432 
92/118 9 CFR 94.16 
9 CFR 94.16 Yes 2 
NE For non-FMD affected 
regions, a certificate of origin 
is required. 
For FMD affected regions, 
certification to UHT U.S. to review if double 
pasteurisation of products 
from FMD affected regions is 
acceptable. 9 CFR 77,78 
9 CFR 77, 78 92/118, 95/341 
92/118 NE 
NE -
49 
- Commodity 
- Species 
Animal/Public 
health . European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 1 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 1 
^^=S=aBS=SSS=SSB^xJ 
15. Minced meat 
Animal health 
- Ruminants 
- Pigs 
Public health 
. VS)— 
Ruminants 
Pigs 64/432, 72/461, 
72/462 
64/432, 72/461, 
72/462 
94/65 9 CFR 94 
9 CFR 94 
9 CFR 301-381 Yes 2 
Yesl 
Yes 3 Additional certification for 
bovines from BSE affected 
countries. 
Establishments listed in 
accordance with footnote (7), 
and fulfilling the relevant 
provisions of footnote (1). U.S. to review rules on BSE 
with respect to high/low 
incidence regions. 
Equivalency shall be granted 
after the U.S. has completed 
verification of veterinary 
delivery systems. This 
process shall be completed 
within 12 months of the date 
of entry into force of the 
agreement. 9 CFR 301-381 72/462 
72/462 
94/65,97/29 NE 
NE 
Yes 3 Derived from meat meeting 
the conditions of point 6 
(fresh meat). 
Establishments listed in 
accordance with footnote (7), 
and fulfilling the relevant 
provisions of footnotes (2), 
(3) and (4). • 
The EC shall evaluate the 
U.S. residue programme, and 
additional information to be 
submitted by the U.S., to 
determine whether it meets 
the EC level of protection. 
This evaluation shall be 
completed within 6 months 
of the entry into force of this 
Agreement. 
The EC shall evaluate the 
U.S. water standards to 
determine whether they meet 
thé EC level of protection. 
This evaluation shall be 
completed within 61 months 
of the entry into force of this 
Agreement. 
50 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 1 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions I 
1 
15. Minced meat - public health - cont'd 
Equivalency (Yes 2) shall be 
granted after the EC has 
completed verification of the 
application of the specified 
conditions. This process shall 
be completed within 12 
months of the entry into force 
of the agreement 
EC to consider reviewing 
scope of definition of minced 
meat. 
16. Meat preparations | 
Animal health 
-Ruminants 
-Equidae 
-Pigs 
-Poultry / Wild 
game / Fanned 
game 64/432, 72/461, 
72/462 
64/432, 72/461, 
72/462 
92/118, 72/462, 
80/215,94/438 9 CFR 94 
9 CFR 94 
9 CFR 94 Yes 2 
Yesl 
Yesl Additional certification for 
bovines from BSE affected 
countries. U.S. to review rules on BSE 
with respect to high/low 
incidence regions. 72/462 
72/462 
91/494, 93/342, 
94/984 NE 
NE 
NE I 
51 
• 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community I 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
16. Meat preparations cont'd 
Public health 
Ruminants (t>> 
Equidae 
Pigs 
Poultry 94/65 9 CFR 301-381 Yes 2/3 Establishments listed in 
accordance with footnote (7), 
and fulfilling the relevant 
provisions of footnote (1). Equivalency shall be granted 
after the U.S. has completed 
verification of veterinary 
delivery systems. This 
process shall be completed 
within 12 months of the date 
of entry into force of the 
agreement. 9 CFR 301-381 94/65,97/29 Yes 3 Derived from meat meeting 
the conditions of point 6 
(fresh meat) and/or 7 
(poultrymeat). 
Establishments listed in 
accordance with footnote (7), 
and fulfilling the relevant 
provisions ' of footnotes (2), 
(3) and (4). The EC shall evaluate the 
U.S. residue programme, and 
additional information to be 
submitted by the U.S., to 
determine whether it meets 
the EC level of protection. 
This evaluation shall be 
completed within 6 months 
of the entry into force of this 
Agreement. 
The EC shall evaluate the 
U.S. water standards to 
determine whether they meet 
the EC level of protection. 
This evaluation shall be 
completed within 6 months 
of the entry into force of this 
Agreement. 
Equivalency shall be granted 
after the EC has completed 
verification of the application 
of the specified conditions. 
This process shall be 
completed within 12 months 
of the entry into force of the 
agreement. 
52 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions 1 
United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
1 -, 
16. Meat preparations - public health - cont'd 
Wild name W 
:armed game (S) 94/65 FIFRA, 
FFDCA, PHSA 
21 CFR 70-82, 
101, 109, 
110.3-110.93, 
113, 170-189, 
510-529,556 
40 CFR 180, 
185 NE Existing trade conditions FIFRA, 
FFDCA, PHSA 
21 CFR 70-82, 
101, 109, 
110.3-110.93, 
113, 170-189, 
510-529,556 
40 CFR 180, 
185 94/65 NE 
—-—i " ' ' i i . n i i ,, .- .i — —_•_.—_ i _—— *""~"3 
17. Animal casings for human consumption | 
Animal health 
-Cattle 
-Pigs 92/118, 64/432, 
72/461,72/462 
92/118, 64/432, 
72/461,72/462 9 CFR 96 
9 CFR 96 Yes 2 
Yes 2 Non-comminglement (see 
footnote 9). 
No trade allowed for 
countries affected by BSE. 
Non-comminglement (see 
footnote 9). 
Certification attesting to 
process and origin for casings 
originating in ASF free 
countries/regions but 
processed in ASF affected 
country/region. U.S. to review rules on BSE 
with respect to high/low 
incidence regions. 
U.S. to review 94.8(a)(i)(v) 
of CFR for non-
comminglement 
U.S. to review 94.8(a)(i)(v) 
of CFR for non-
comminglement. 92/118 
94/187 
92/118 
94/187 NE 
NE 
• 
53 
1 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Commumty 1 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 1 
17. Animal casings for human consumption - animal health - cont'd 1 
•Sheep 
•Goats 
Public health 92/118, 64/432, 
72/461,72/462 
77/99 9 CFR 96 Yes 2 Non-comminglement (see 
footnote 9). 
No trade allowed for 
countries affected by BSE 
Certification attesting to 
process and country of origin 
for casings originating in 
BSE free countries but 
processed in BSE affected 
country. U.S. to review 94.8(a)(i)(v) 
of CFR for non-
comminglement. 
FFDCA, 
FIFRA, PHSA 
21 CFR 70-82, 
101, 109, 
110.3-110.93, 
113, 114, 170-
189, 510-529, 
556 40 CFR 
180,185 NE 92/118 
94/187 NE 
FFDCA, 
FIFRA, PHSA 
21 .CFR 70-82, 
101, 109, 
110.3-110.93, 
113, 114, 170-
189, 510-529, 
556 40 CFR 
180,185 77/99, 92/118 
Draft Decision 
notified to 
WTO NE 
54 
1 
- Commodity 
- Species 
Animal/Public 
health 
i European Community Exports to the United States 
Trade Conditions 
T;C Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 1 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 1 
18. Animal casings not for human consumption | 
Animal health 
•Cattle 
-Pigs 
-Sheep 
-Goats 92/118,64/432 
72/461,72/462 
92/118,64/4327 
2/461,72/462 
92/118,64/4327 
2/461,72/462 9 CFR 96 
9 CFR 96 
9 CFR 96 Yes 2 
Yes 2 
Yes 2 Non-comminglement (sec 
footnote 9). 
No trade allowed for 
countries affected by BSE 
Non-comminglement (see 
footnote 9). 
Certification attesting to 
process and origin for casings 
originating in ASF free 
countries/regions but 
processed in ASF affected 
country/region. 
Non-comminglement (see 
footnote 9). 
No trade allowed for 
countries affected by BSE. 
Certification attesting to 
process and country of origin 
for casings originating in 
BSE free countries but 
processed in BSE affected 
country. U.S. to review rules on BSE 
with respect to high/low 
incidence regions. 
U.S. to review 94.8(a)(i)(v) 
of CFR for non-
comminglement 
U.S. to review 94.8(a)(i)(v) 
of CFR for non-
comminglement 
U.S. to review 94.8(a)(i)(v) 
of CFR for non-
comminglement 92/118 
94/1^7 
92/118 
94/187 
92/118 
94/187 NE 
NE 
NE 1 
'• 
55 
- Commodity 
- Species 
- Animal/Public 
ij health 
.! European Community Exports to the United States 
Trade Conditions 
HC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
19. Hides and skins - • 1 
Animal health 
-Cattle 
-Sheep 
-Goats 
! TV 
-Pigs 92/118, 72/461, 
72/462 9 CFR 95.5, 
95.6 Yesl 92/118 
97/168 E EC to identify basis fori 
salting requirement | 
120. Canned petfood containing high/low risk material 
Containing 
mammalian 
.material 
Containing 
only non-
mammalian 
material 92/118 
90/667 
92/562 
92/118 
90/667 
92/562 9 CFR 94,95 
FFDCA, FIFRA 
21 CFR 110.3-
110.93, 507-
509, 570, 573-
589 
99 CFR 94,95 
FFDCA, FIFRA 
21 CFR 110.3-
110.93, 507-
509, 570, 573-
589 Yes 2 
Yes 2 Special rules for BSE 
countries. Shelf stable for 
remainder. 
Shelf stable for remainder. U.S. to review rules on BSE 
with respect to high/low 
incidence regions. FFDCA, FIFRA 
21 CFR 110.3-
110.93, 507-
509, 570, 573-
589 
FFDCA, FIFRA 
21 CFR 110.3-
110.93, 507-
509, 570, 573-
589 92/118 
94/309 
96/449 
97/199 
92/118 
94/309 
96/449 
97/199 Establishments shall have 
been validated by the U.S. for 
alternative heat treatment 
including 30 day freedom 
from Clostridia EC to examine U.S. claim to | 
be BSE free. 
EC to consider alternative! 
guarantees for mammalian 
material, including U.S. 
proposal to remove all risk 
material of known U.S. TSE 
species from petfood. 
56 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 1 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
-
21. Canned petfood containing only low risk material 
Containing 
mammalian 
material 92/118,90/667 9 CFR 94, 95 
FFDCA, FIFRA 
21 CFR 110.3-
110.93, 507-
509, 570, 573-
589 Yes 2 Special rules for BSE 
countries. Shelf stable for 
remainder. U.S. to review rules on BSE 
with respect to high/low 
incidence regions FFDCA, FIFRA 
21 CFR 110.3-
110.93, 507-
509, 570, 573-
589 92/118,94/309 
96/449,97/199 
- . Containing 
only non-
mammalian ' 
material 92/118,90/667 9 CFR 94, 95 
FFDCA, FIFRA 
21 CFR 110.3-
110.93, 507-
509, 570, 573-
589 Yes 2 Shelf stable. FFDCA, FIFRA 
21 CFR 110.3-
110.93, 507-
509, 570, 573-
589 92/118,94/309 
96/449,97/199 Establishments shall have 
been validated by the U.S. for 
alternative heat treatment 
including 30 day freedom 
from Clostridia 
22. Dry and semi moist petfood containing only low risk material 
92/118 
94/309 9 CFR 94, 95 
FFDCA, FIFRA 
21 CFR 110.3-
110.93, 507-
509, 570, 573-
589 Yes 2 Restrictions 
countries for BSE U.S. to examine EC 90° core 
temperature requirement as 
providing sufficient 
guarantees against FMD, 
CSF,SVD,ASFandND. 
U.S. to review rules on BSE FFDCA, FIFRA 
21 CFR 110.3-
110.93, 507-
509, 570, 573-
589 92/118,94/309 
96/449,97/199 Î Establishments shall have 
been validated by the U.S. for 
alternative heat treatment 
including 30 day freedom 
from Clostridia 
57 
1 
- Commodity 
- Species 
/\ninial/Ptiblic 
health 
< . European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community j 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions , 8 
123. Dry and semi moist petfood containing high/low risk material 
1 H -, — ' 1 -. 1.. ~ 1 ~ .... >• ~~^ 1. 
ma 
ma Contain 
m mal i an 
terial inc 
Containing 
only non-
mammalian 
material 92/118,94/309 
92/118,94/309 9 CFR 94, 95 
FFDCA, FIFRA 
21 CFR 110.3-
110.93, 507-
509, 570, 573-
589 
9 CFR 94, 95 
FFDCA, FIFRA 
21 CFR 110.3-
110.93, 507-
509, 570, 573-
589 Yes 2 
Yesl Restrictions 
countries for BSE U.S. to examine EC 90° C 
core temperature requirement 
as providing sufficient 
guarantees against FMD, 
CSF.SVD.ASFandND. 
U.S. to review rules on BSE 
with respect to high/low 
incidence regions. 
U.S. to examine EC 90° C 
core temperature requirement 
as providing sufficient 
guarantees against ND. FFDCA, FIFRA 
21 CFR 110.3-
110.93, 507-
509, 570, 573-
589 
FFDCA, FIFRA 
21 CFR 110.3-
110.93, 507-
509, 570, 573-
589 92/118,94/344 
96/449,97/199 
92/118,94/344 
97/199 Establishments shall have 
been validated by the V.S. for 
alternative heat treatment 
including 30 day freedom 
from Clostridia EC to examine U.S. claim to 
be BSE free. 
EC to consider alternative 
guarantees for mammalian 
material, including U.S. 
proposal to remove all risk 
material of known U.S. TSE 
species from petfood. 
58 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community J 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 1 
24. Bones and bone products for human consumption ("other products" as defined in 77/99/EEC) 
Animal health 
Fresh meat 
(ruminants, 
horses, pigs) 
Farmed game -
pigs, deer 
Fresh meat -
poultry 
Feathered 
farmed and 
wild same 
Wild Game, 
Pics Deer 
Public health 
•Ml • IM 
All species 
Feathered, 
farmed and 
wild game 64/432 
72/461 
80/215 
72/462 
91/495 
92/118,80/215 
72/462, 94/438 
92/45 
91/495 
92/45 
77/99,92/118 
64/433, 77/99, 
92/118 9 CFR 95 
9 CFR 95 
9 CFR 95 
9 CFR 95 
9 CFR 95 
9 CFR 95 
FIFRA, 
FFDCA, 
21 CFR 70-82, 
108, 109, 
110.3-110.93, 
113, 170-189, 
510-529/556 Yes 2 
Yes 2 
Yesl 
Yesl 
Yes 2 
NE 
NE Restrictions for BSE 
countries. 
Restrictions for BSE 
countries. 
Restrictions for BSE 
countries. U.S. to review rules on BSE 
with respect to high/low 
incidence regions. 
U.S. to review rules on BSE 
with respect to high/low 
incidence regions. 
U.S. to review rules on BSE 
with respect to high/low 
incidence regions. 
FIFRA, 
FFDCA, 
21 CFR 70-82, 
108, 109, 
110.3-110.93, 
113, 170-189, 
510-529,556 72/462 
97/221 
91/495 
92/118 
92/45 
91/495 
92/45 
77/99,92/118 
77/99,92/118 
Draft Decision 
notified to 
WTO NE 
NE 
NE 
NE 
NE 
NE 
NE EC to consider establishing! 
conditions. \ 
59 
j - Commodity 
J- Species 
Animal/Public 
fhclth European Community Exports to the United States 
Trade Conditions 
F.C Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
P25. Bones, horns and hooves and their products not for human consumption 
Animal health 96/239 9CFR95 Ycsl 9 CFR 53 94/446 NE 
26. Processed animal protein for human consumption 
Animal health 
Fresh meat 
(•/uminants, 
equidae, pigs) 
Farmed game -
nigs, deer 
Fresh meat -
poultry 
Feathered 
farmed and 
wild name 
Wild Game, 
Pigs Deer 64/432,72/461 
80/215,72/462 
91/495 
92/118,80/215 
72/462,94/438 
92/45 
91/495 
92/45 9 CFR 95 
9 CFR 95 
9 CFR 95 
9 CFR 95 
9 CFR 95 Yes 2 
Yes 2 
Yesl 
Yesl 
Yes 2 Not accepted from BSE 
countries. 
Not accepted from BSE 
countries. 
Not accepted from BSE 
countries. U.S. to review rules on BSE 
with respect to high/low 
incidence regions. 
U.S. to review rules on BSE 
with respect to high/low 
incidence regions. 
U.S. to review rules on BSE 
with respect to high/low 
incidence regions. 72/462,97/221 
91/495 
92/118 
92/45 
91/495 
92/45 NE 
NE 
NE 
NE 
NE EC to examine U.S. claim to 
be BSE free. 
EC to consider alternative 
guarantees for mammalian 
material, including U.S. 
proposal to remove all risk! 
material of known U.S. TSEI 
species from petfood.. | 
I 
60 
1 
J - CiMiunoditv 
1 i 
- 'sj'OsU'S 
j • Animiil'Tulilii; 
ihcilih 
II European Community Exports to the United States 
Trade Conditions 
I'C Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
26. Processed animal protein for human consumption cont'd | 
Public health 
All species (A> 
Feathered. 
farmed and 
•i i (<s) 
wild game 
I 77/99,92/118 
77/99 FIFRA, PHSA, 
FFDCA, 
21 CFR 70-82, 
108, 109, 
110.3-110.93, 
113, 170-189, 
510-529,556 Yesl 
NE FIFRA, PHSA, 
FFDCA, 
21 CFR 70-82, 
108, 109, 
110.3-110.93, 
113, 170-189, 
510-529,556 77/99,92/118 
77/99,92/118 
Draft Decision 
notified to 
WTO NE 
NE . 
' 
27. Processed animal protein not for human consumption 
Containing material of manu 
Ruminants 
1 Non-ruminants 92/118 
90/667 
92/118 
90/667 malian origin 
9 CFR 95 
FIFRA, 
FFDCA, 
21 CFR 110.3-
110.93, 507-
509, 570, 573-
589 
9 CFR 95 
FIFRA, 
FFDCA, 
21 CFR 110.3-
110.93, 507-
509, 570, 573-
589 Yes 2 
Yes 3 Not accepted from BSE 
countries. U.S. to review rules on BSE 
with respect to high/low 
incidence regions. FIFRA, 
FFDCA, 
21 CFR 110.3-
110.93, 507-
509, 570, 573-
589 
FIFRA, 
FFDCA, 
21 CFR 110.3-
110.93, 507-
509, 570, 573-
589 90/667,92/118 
92/562,94/344 
96/449,97/198 
92/118, 90/667, 
96/449 NE 
NE Establishments shall have 
been validated by the U.S. for 
alternative heat treatment 
including 30 day freedom 
from Clostridia 1 
EC to examine U.S. claim to | 
be BSE free. j 
EC to consider alternative 
guarantees for mammalian 
material, including U.S. 
proposal to remove all risk 
material of known U.S. TSE 
species from petfood. 
i 
61 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community J 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 1 
27. Processed animal protein not for human consumption cont'd 
Containing only material of non mammalian origin 
Poultry 
fish and 92/118,90/667 9 CFR 95 Yesl 90/667,92/118 
92/562, 94/344, 
97/198 NE Establishments shall have 
been validated by the U.S. for 
alternative heat treatment 
including 30 day freedom 
from Clostridia. 
Non-ruminants 92/1 IS, 90/667 9 CFR 95 Yesl 92/118,90/667 NE 
28. Scrum of eq uidae 
Animal health 92/118,94/143 9 CFR 95,122 NE 92/118,94/143 NE 
29. Blood and blood products intended for human consumption I 
Animal health 
Fresh meat 
(ruminants, 
equidac, pigs) 
Farmed game -
pigs, deer 
Fresh meat -
poultry 64/432, 72/461 
80/215,72/462 
91/495 
92/118,80/215 
72/462, 94/438 9 CFR 95,122 
9 CFR 95,122 
9 CFR 95, 122 E 
Yes 2 
Yesl BSE rules for ruminants. 
BSE rules for ruminants. U.S. to review rules on BSE 
with respect to high/low 
incidence regions. 
U.S. to produce generic 
conditions for EC 
U.S. to review rules on BSE 
with respect to high/low 
incidence regions. 9 CFR 53 72/462 
97/221 
91/495 
92/118 NE 
NE 
NE 
I 
62 
- Commodity 
- Species 
Animal/l'ublic 
health European Community Exports to the United States 
Trade Conditions 
HC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community | 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 8 
29. Blood and blood products intended for human consumption - Animal health - cont'd [ 
Feathered 
fanned and 
wild game 
Wild Game, 
Pius Deer 
Public health 92/45,91/495 
92/45 
77/99 9 CFR 95, 122 
9 CFR 95,122 
9 CFR 301-381, 
416, 417 
FFDCA, 
FIFRA, 21 CFR 
110.3-110.93, 
507-509, 570, 
573-589 Yesl 
Yesl 
NE 9 CFR 301-381, 
416, 417 
FFDCA, 
FIFRA, 21 CFR 
110.3-110.93, 
507-509, 570, 
573-589 92/45 
91/495 
92/45 
77/99,92/118 
Draft Decision 
notified to 
WTO NE 
NE 
NE 1 
EC to consider establishing! 
conditions. j 
30. Blood and blood products not intended for human consumption 
Animal health 92/183,92/118 9 CFR 95.4, 
122 Yes 2 BSE rules for ruminants. 
Permit required U.S. to review rules on BSE 
with respect to high/low 
incidence regions. 9 CFR 53 92/183,92/118 Yes 2 Bluetongue 
.requirements. treatment EC to consider use of tests 
for Bluetongue in place ofj 
treatment 
63 
- Commodity 
- Species 
Animal/Public 
health 1 European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Commumty 1 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 1 
31. Lard and rendered fats intended for human consumption 
Animal health 
Fresh meat 
J (ruminants. 
horses, pigs) 
Fanned game -
pigs, deer 
Fresh meat 
poultry 
Feathered farmed 
and wild game 
Wild Game. Pigs 
i Deer 
Public health 
All species ^' 
Feathered, 
farmed and 
•i. • (S) 
wild game 64/432 
72/461 
80/215 
91/495 
92/118 
80/215 
94/438 
92/45 
91/495 
92/45 
77/99,92/118 
77/99 9 CFR 95 
9 CFR 95 
9 CFR 95 
9 CFR 95 
9 CFR 95 
9 CFR 301-381, 
416, 417 
FIFRA, PHSA, 
FFDCA, 
21 CFR 70-82, 
108, 109, 
110.3-110.93, 
113, 170-189, 
j 510-529, 556 Yes 2 
Yes 2 
Yesl 
Yesl 
Yes 2 
NE 
NE BSE rules for ruminants. 
BSE rules for ruminants. 
BSE rules for ruminants: ^ 
U.S. to review rules on BSE 
with respect to high/low 
incidence regions. 
U.S. to review rules on BSE 
with respect to high/low 
incidence regions. 
* 
U.S. to review rules on BSE 
with respect to high/low 
incidence regions. 
9 CFR 301-381, 
416, 417 
FIFRA, PHSA, 
FFDCA, 
21 CFR 70-82, 
108, 109, 
110.3-110.93, 
113, 170-189, 
510-529,556 72/462 
97/221 
91/495 
92/118 
92/45 
91/495 
92/45 
77/99,92/118 
77/99,92/118 
Draft Decision 
notified to 
WTO NE 
NE 
NE 
NE 
NE 
NE 
NE 
• 
64 
- Commodity 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions ——•—————— ' '—' '—'—» 
United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
32. Lard and rendered fats not intended for human consumption 
92/118 
90/667 
72/461 9 CFR 95 Yes 2 BSE rules for ruminants. U.S. to review rules on BSE 
with respect to high/low 
incidence regions. 92/118 
Draft Decision 
notified to 
WTO NE EC to review requirements to 
consider inclusion of 
alternative heat treatment 
systems. 
EC to review U.S. 
bacteriological testing regime 
for protein fraction 
33. Raw material for feeding stuffs, pharmaceutical or technical use 
Animal health!92"18 ]9CFR95,i22 Yesl 9 CFR 53 92/118 EC to consider laying downl 
certification requirements for) 
imports 
34. Apiculture products for apiculture 
Animal health |92/118 92/118,94/860 NE 
35. Game trophies 
Animal health 92/118 9 CFR 95 Yesl 9 CFR 53 92/118 
96/590 
65 
Commodity 
Species 
Animnl/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Commumty i 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
36. Manure 
U.S. to provide temperature 
requirements for manure 
from regions affected by 
serious transmissible disease Animal health P118 9 CFR 95 9 CFR 53 92/118 
37. Wool, feathers and hair 
Animal health 
AVool 
-Pigbristlc 
Public health 92/118 
92/118 9 CFR 95 
9 CFR 95 
FFDCA, PHSA 
21 CFR 
1240.70 Yesl 
Yesl 
NE r 
9 CFR 53 
9 CFR 53 
FFDCA, PHSA 
21 CFR 
1240.70 92/118 
92/118 
94/435 NE 
NE 
NE ! 
38. Honey -. | 
Animal health 
Public health 92/118 FFDCA, 
FIFRA, PHSA 
21 CFR 70-82, 
109, 110.3-
110.93, 
520.182, 
520.1660d NE 
NE FFDCA, 
FIFRA, PHSA 
21 CFR 70-82, 
109, 110.3-
110.93, 
520.182, 
520.1660d 92/118 NE 
NE 1 
66 
- Commodity 
- Species 
Animnl/Public 
health European Community Exports to the United States 
Trade Conditions 
EC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions • 
39. Frog's legs | 
Animal health 
Public health 92/118,96/340 FFDCA, 
FIFRA, PHSA 
21 CFR 70-82, 
108, 110.3-
110.93, 113, 
114,123,1240 NE 
-FFDCA, 
FIFRA, PHSA 
21 CFR 70-82, 
108, 110.3-
110.93, 113, 
114,123,1240 92/118,96/340 NE EC to review U.S. HACCP j 
rules when submitted. 
40. Snails for human consumption | 
Animal health 
Public health 92/118,96/340 FFDCA, 
FIFRA, PHSA 
21 CFR 70-82, 
108, 110.3-
110.93, 113, 
114,123,1240 NE FFDCA, 
FIFRA, PHSA 
21 CFR 70-82, 
108, 110.3-
110.93, 113, 
114,123,1240 92/118,96/340 NE • 
67 
Commoditv 
S;vcies 
l1 • Animal/Public European Community Exports to the United States 
Trade Conditions 
F.C Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Community 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
S-U. Egg products for human consumption 
r-,—: r 
/viumal health 90/539 9 CFR 94 Yes 2 Permit required from areas 
affected by Newcastle 
disease. U.S. to review permit 
requirement. 
U.S. to supply information on 
the legal basis for recognition 
of equivalence. 
U.S. to complete assessment 
of EC public health 
legislation 90/539,93/342 Yesl 
Public health 89/437, 
92/118. 91/684, 
96/23 7 CFR 59 
EPIA Public 
Law 91-597 7 CFR 59 
EPIA Public 
Law 91-597 89/437, 91/684, 
92/118, 96/23, 
97/38 Establishments listed 
accordance with footnote 
(7), and fulfilling the 
relevant provisions of 
footnote (2). 
The following tests are to be 
conducted, as specified in 
Annex VI to Directive 
89/437, on U.S. egg 
products for dispatch to 
Europe: 
Chemical tests 
- 3 OH butyric acid 
- lactic acid 
- succinic acid 
- egg shell remains, egg 
membrane, other particles 
Bacteriological tests 
- mesophile counts 
- cntcrobactcriaccac 
- salmonella 
- staphylococcus 
Methods 
Internationally recognised 
methods such as: ISO, 
NMKL, AOAC EC to complete assessment of 
U.S. public health legislation. 
68 
- Commodity 
i 
- Species 
Animal/Public 
health European Community Exports to the United States 
Trade Conditions 
FC Standards U.S. Standards Equiv 
(Cat) Special Conditions Actions United States Exports to the European Commumty 1 
Trade Conditions 
U.S. Standards EC Standards Equiv 
(Cat) Special Conditions Actions 
42. Shell Eggs 
Animal health P539 9 CFR 94 Yes 2 Permit required from areas 
affected by Newcastle 
disease. U.S. to review permit 
requirement. 9 CFR 94 90/539,93/342 Yesl 
Public health 89/437,91/684 
94/371,96/23 FFDCA, 
FIFRA, PHSA, 
EPIA 
21 CFR 
5.10(a)(4) and 
(a) (13), 70-82, 
100.135, 110.3-
110.93, 
172.140, 
172.882, 
182.884, 
520, 524, 
558,1240 
40 CFR 180 
7 CFR 56 U.S. to review legal basis for 
recognition of equivalence. 
U.S. to complete assessment 
of EC public health 
legislation. 
178, 
556, FFDCA, 
FIFRA, PHSA, 
EPIA 
21 CFR 
5.10(a)(4) and 
(a) (13), 70-82, 
100.135, 110.3-
110.93, 
172.140, 
172.882, 
182.884, 
520, 524, 
558,1240 
40 CFR 180 
7 CFR 56 89/437,91/684 
94/371,96/23 
178, 
556, EC to complete assessment of j 
U.S. public health legislation 
43. Gelatin for human consumption and technical use | 
Animal health 
Public health 92/118 9 CFR 94 
FFDCA, 
FIFRA, PHSA 
21 CFR 70-82, 
109, 110.3-
110.93, 570, 
573-589 NE 
NE FFDCA, 
FIFRA, PHSA 
21 CFR 70-82, 
109, 110.3-
110.93, 570, 
573-589 92/118 NE 
NE ' I 
69 
Footnote 1 
The Pathogen Reduction: Hazard Analysis and Critical Control Point (HACCP) Systems; Final Rule was published at 61 Federal Register 38806-38989 and amends various 
provisions of CFR Parts 304, 310, 320, 327, 381, 416 and 417. 
Provisions on SSOPs and E coli testing applicable. 
( 
The U.S. and the EC shall discuss, well in advance of their date of implementation, the staged elements in the above rule to determine whether any further special conditions are 
needed. 
Footnote 2 Horizontal Issues, Meat, Meat Products, Game Meat, Poultry Meat, Minced Meat, Meat Preparations, Egg Products 
a) Packaging material 
Packaging material shall be kept in separate rooms that are used exclusively for this purpose and free of dust and vermin. 
Packaging material shall not be stored on the floor. 
Waxed assembled boxes shall not be nested, unless a liner will be added. 
Assembled boxes with liners shall not be nested. 
Boxes shall not be handled by personnel who are handling exposed product. 
Boxes shall be assembled in a sanitary manner, either in a separate room or, if on the cutting room floor, never within 3 metres of exposed product. 
70 
b) Facility requirements for light coloured walls and cove molding 
Walls shall be smooth, durable, impermeable, and of a colour which permits detection of insanitary conditions. 
Walls shall have washable surfaces. 
Walls and floor junctures shall be constructed and maintained so as to assure that surfaces are clean and free of contamination. Establishments that do not use cove 
molding to provide a smooth transition from floor to wall to facilitate cleaning must provide an equivalent alternative means, such as sealing of cracks between walls 
and floors, to maintain sanitary conditions. 
c) Medical certification by a medical doctor 
Prior to employment, new employees shall be examined by a medical doctor or by another medically qualified person who is sufficiently trained to identify 
communicable diseases and working under the supervision of a medical doctor. 
Establishments shall have in place an appropriate program to continuously monitor employee health. 
Pre-employment examinations and ongoing health monitoring shall be carried out either by a medical doctor or by a person with appropriate medical training.(e.g. a ., 
physician's assistant or a registered nurse). 
All cases of suspected disease shall be referred to a medical doctor for diagnosis. 
Establishments shall keep records of medical examinations and shall make those records available to auditors upon request. 
d) Wooden pallets in exposed product areas 
The use of wooden pallets in areas where there is exposed product shall be phased out. In the interim: 
no wooden pallets shall be used within 3 meters of exposed product; 
pallets shall be clean, structurally sound, and covered with a sanitary plastic sheet. 
Those establishments which are already using plastic pallets shall continue to do so. 
When wooden pallets arc used in coolers or freezers, all product present shall be hygienically packaged to prevent contact of product with wood. 
71 
e) Separation of lavatories and work areas 
Toilet rooms shall be properly ventilated and shall be separated from exposed product rooms by either a vestibule or a dressing room. 
0 Dry Storage of Non-Food Material 
Detergents, disinfectants and similar substances shall be stored separately from food and from wrapping and packaging material. 
g) Water Testing 
Water testing shall continue to be carried out in accordance with EC requirements, 
dot note 3 Fresh meat, game meat, meat products, minced meat and meat preparations of red meat species and poultry 
a) Waste water 
All establishments shall have an efficient drainage and plumbing system, and all drains and gutters shall be properly installed with traps and vents approved by FSIS, in 
accordance with 9 CFR 381.49 (a), (c) 
b) Separate storage of edible and inedible products 
Condemned and other inedible meat and offal shall be removed in a hygienic manner, and as quickly as possible, from rooms containing edible material. 
c) Separate storage of packaged and unpackaged products 
Un packaged meat may not be stored in chilling or freezer rooms containing packaged meat. 
d) Structural wood 
Wooden structures shall be in good condition, impermeable, smooth, durable rot-proof and sealed with a waterproof coating. 
e) Use of suspended showers, spravs and hoses 
Meat shall not be contaminated by splashing. 
They shall not be used as a substitute for handwashing facilities. 
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0 Sterilization of equipment 
Establishments shall provide sterilization equipment (batch or local sterilizers) to clean utensils as often as necessary. Implements such as knives or hooks which come 
into contact with meat shall be cleaned and sterilized frequently, and in any case whenever they have been in contact with contaminated material or surfaces such as the 
external surfaces of hides. Sterilization shall be done with hot (>82°C) water. 
Footnote 4 Additional Guarantees for Finland and Sweden 
For trade from the U.S. to Sweden and Finland, the U.S. will certify in accordance with Council Decision 95/409/EC (Fresh: Veal, beef and pigmeat), Council Decision 
95/410/EC (live poultry for slaughter), Council Decision 95/411/EC (Fresh poultrymeat), Commission Decision 95/160/EC (breeding poultry and day old chicks), Commission 
Decision 95/161/EC (laying hens) and Commission Decision 95/168/EC (table eggs for human consumption). 
No attestation is required for fresh meat as defined in 72/462/EEC destined for manufacturing into meat products within Sweden/Finland. 
Footnote 5 Fresh meat, game meat, meat products, minced meat, meat preparations 
a) Accommodation for sick and suspect animals 
Wood shall not be used for pens for sick and suspect animals. 
Sick and suspect animals shall not be allowed to come into contact with animals intended for slaughter for export to the Community. 
Pens for sick and suspect animals shall be sited and constructed to preclude contact with animals intended for slaughter for export to the Community and effluent from 
such pens shall not flow into adjoining pens or passageways. 
b) Veterinary supervision of ante-mortem inspection 
All cattle intended for slaughter for export to the EC shall be inspected by an official FSIS veterinarian, except: 
feedlot animals inspected at the feedlot by a USDA accredited veterinarian; and 
other fattening animals under the age of 30 months inspected at the holding by a USDA accredited veterinarian; 
which shall be inspected by an official FSIS inspector with appropriate training, knowledge, skills and abilities to carry out this function. 
73 
All pigs intended for slaughter for export to the EC shall be inspected by an official FSIS veterinarian, except for market hogs (animals up to 1 year of age), which shall 
be inspected by an official FSIS inspector with appropriate training, knowledge, skills and abilities to carry out this function. 
All animals demonstrating abnormal signs shall be diagnosed and disposed of by an official FSIS veterinarian. ' 
c) Trichina testing 
Establishments shall test horsemeat for trichinae. 
Pigmeat shall be tested or subjected to cold treatment in accordance with 9CFR 318.10. 
d) Opening of stomachs and intestines 
There must be a separate room for emptying and cleaning stomachs and intestines, unless the processing is done by closed-circuit mechanical equipment which avoids 
contamination and eliminates odours. 
e) Pig Hearts Incision 
For market hogs (animals up to 1 year old) which are destined or from which some part is destined for the EC a statistically representative sample, both in numbers or 
percentage and geographical origin, of hearts shall be incised and their interior surfaces inspected by FSIS personnel, with the results being recorded. 
The U.S. shall inform the EC of the sampling methodology, level of confidence, and programme they intend to use for the sampling referred to above. 
Hearts of all sows and boars (animals over 1 year of age) which are destined or from which some part is destined for the EC shall be incised and their interior surfaces 
inspected by FSIS personnel, with the results being recorded. 
f) Batch condemnation 
If carcases, offals and blood are not correlated at the final post-mortem inspection point, a batch system shall be operated in such a way that FSIS can demonstrate that if 
a carcass is condemned its offal and blood shall also be condemned. 
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g) Partial Approval 
The veterinary authorities of the -EC and the U.S. may on a bilateral basis grant request for partial approval of red meat establishments for certain products, in accordance 
with the general and specific provisions of this agreement in respect of hygienic production and ante and post mortem inspection of slaughter animals, under the following 
conditions: 
1. The establishment shall develop a Quality Assurance (QA) program which addresses the mode of operation, the identification of product, and the segregation of the 
product from receiving to shipping. Establishments which want to apply for partial approval must meet the facility requirements to ensure physical and/or time 
separation of approved and non-approved products. 
2. The QA shall include an establishment monitoring schedule and a log to document both monitoring actions and corrective actions. 
3. The QA program shall be acceptable to the regulatory inspector in charge of the establishment and the controlling veterinary authority of the importing party on 
request. 
4 The regulatory inspector in charge of the establishment shall monitor the establishment's application of the QA program and document such monitoring and ensure 
correction of deficiencies. 
5. The importing Party may verify the practical implementation of the QA program. In this case, the establishment needs to be in a position to demonstrate the program 
on the spot during an inspection. For this purpose, all relevant documentation shall be presented. 
6. Should an inspection on the spot and/or the document-check in an establishment reveal serious deficiencies, the possibility of partial approval may either be refused 
or revoked. 
Footnote 6 Poultrymeat 
n) Countcrflow Chilline 
Where countcrflow chilling systems are used, alternative chilling systems to the EC standards may be used providing equivalent guarantees as regards avoidance of 
cross contamination, and carcass temperatures at the point of exit from the chilling systems as set out under point (b) below, which have been validated and assessed by 
FSIS before the establishment is proposed for listing for export to the EC. This validation and assessment shall be carried out without the use of antimicrobial treatment 
(decontamination), throughout a full day's production, and with microbiological analyses for aerobic plate counts, enterobacteriacae and E coli before and after chilling. 
This assessment shall be carried out each time any changes are made to a plant's chilling system. Records shall be kept of the validations and assessments, and FSIS 
shall make these available to the EC. , 
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b) Poultry product temperature requirements 
Poultry shall be chilled to an internal temperature of 40 degrees F (4.4 degrees C) in the shortest time possible after slaughter. 
In the case of small birds (up to 6 pounds), the internal temperature of 40 degrees shall be achieved by the end of the immersion chilling process. 
Where crushed ice is used to chill large birds (over 6 pounds) after immersion chilling, such use must not result in cross contamination of the product. 
When further processing (cutting) occurs after poultry has been chilled to 40 degrees F, the internal temperature may exceed 40 degrees F for a maximum of one hour, 
but may not exceed 50 degrees F (10 degrees C). 
(Transportation temperature shall be in accordance with 9 CFR 381.66.) 
c) Crushed Ice 
The use of crushed ice must not result in cross contamination of the product. When crushed ice is used for further transport or storage, stacking of boxes with leakholes 
or other practices which could result in cross contamination shall be prohibited. 
ootnotc 7 Establishment Listing (applicable to all products where listing provisions apply) 
1. The exporting Party is responsible for ensuring that establishments/plants authorised to export, and products certified for export, meet the relevant requirements. 
The exporting Party shall screen establishments to ensure that they meet the relevant requirements before proposing establishments for listing for export. The list, or 
lists, of approved establishments, and additions and deletions to such lists, shall be supplied to the importing Party by the exporting Party. The importing Party shall 
make modifications to the lists of approved establishments efficiently, on the basis of the information supplied by the exporting Party. Dissemination of such lists shall 
be carried out without delay*. 
2. The importing Party may carry out verification procedures, including inspection of the establishments, to ensure that the relevant requirements are being met. 
.3. The Parties will work towards increasing the responsibility for the management of lists of establishments by the exporting Party in the light of experience obtained under 
the operation of the provisions of paragraphs 1 and 2. 
' 4. The Parties will review the functioning of the above mentioned provisions regarding lists of establishments in the light of experience at each meeting of the Committee 
provided for under Article 14, and for the first time no later than 31 December 1997. 
i 
* The EC will carry out this commitment in accordance with the procedure laid down in Article 5 of Council Decision 95/408/EC. The U.S. will carry out this 
commitment in accordance with a similar timetable. 
76 
Footnote 8 Bison and Water Buffalo 
For exports to the U.S. bison and water buffalo are considered as game meat. 
For exports to the EC bison and water buffalo are considered as fresh meat. 
Footnote 9 Non-Comminglemcnt - Meat, Meat Products, Game Meat, Poultry Meat, Minced Meat, Meat Preparations 
Establishments which slaughter both animals whose meat is eligible for export and animals whose meat is not eligible for export to one of the Parties, or handle such meat, shall 
comply with the following conditions: 
1. Animals from which the meat is intended for export shall be kept separate from those which are not of the same status while at the slaughter establishment. 
2. Following slaughter of animals which are not eligible for export and before slaughter of animals eligible for export purposes, all areas, utensils and equipment liable to 
contact the live animals and meat, including stunning, bleeding, flaying, deboning, cutting and packing areas shall be cleaned and disinfected. Staff shall change into clean 
protective clothing and wash their hands and boots thoroughly. 
3. Meat intended for export shall not be handled, cut or otherwise processed in the same room at the same time as meat not eligible for export. 
4. Meat intended for export shall be packed in clean new packaging which is clearly distinguishable from that containing meat not eligible for export. It shall be stored in such a 
way as to ensure that no cross contamination occurs. 
5. Records of the origin of the animals from which the meat is produced shall be retained for a period of 6 months after export. They shall be available for inspection by the 
Regulatory Authority. 
6. Compliance with the above conditions shall be certified by an official veterinarian. 
Footnote 10 Milk and Milk Products not for human consumption 
Excludes products regulated as animal drugs in the U.S. . ' 
Footnote 11 Residue Testing 
Residue testing shall continue to be carried out by the U.S. in accordance with applicable EC requirements. 
77 
ANNEX VI 
GUIDELINES FOR CONDUCTING AN AUDIT 
Where standards, guidelines, or recommendations pertaining to the conduct of audits are adopted by one of 
the relevant international standard-setting organisations, the Parties will review the contents of this Annex, and 
make any appropriate modifications. 
GENERAL PROVISIONS 
1. Definitions 
The following definitions shall apply to terms used in this annex: 
1.1. audit - assessment of performance. 
1.2. auditee - the exporting Party whose enforcement and control programme is the subject of the audit. 
1.3. auditor - the importing Party that conducts the audit. 
1.4. establishment - processing plant for animals or animal products. 
1.5. facility - site other than a processing plants where animals or animal products might be handled, 
excluding retail premises. 
2. general Principles 
2.1. The auditor and the auditee should co-operate in carrying out audits in accordance with the 
provisions set out in this Annex. The audit team should include representatives of both the auditor 
and the auditee, and the auditee should designate personnel responsible for facilitating the audit. 
Specialised professional skills may be necessary to carry out audits of specialised systems and 
programmes. 
2.2. Audits should be designed to check the effectiveness of the auditee's enforcement and control 
programme rather than to reject individual animals, consignments of food or establishments. 
2.3. The auditee must operate a documented programme to demonstrate to the auditor that standards are 
being met on a consistent basis. 
2.4. The frequency of audits should be based on the performance of the exporting Party in carrying out its 
enforcement and control programme. A low level of performance should result in an increased 
frequency of audit, for example to ensure that unsatisfactory performance has been corrected. 
2.5. Audits, and the decisions based on them, should be made in a transparent and consistent manner. 
78 
PROCEDURES 
3. Preparation of the Audit Plan 
In consultation with the auditee, the auditor should prepare an audit plan that covers the following points: 
3.1. the subject, depth and scope of the audit; 
3.2. the date and place of the audit, and the types of any establishments or facilities to be visited so that 
appropriate audit team members may be chosen; 
3.3. a timetable up to and including the presentation of the final report; 
3.4. the language or languages in which the audit will be conducted and the report written; 
3.5. the identity of the members of the audit team, including the leader; 
3.6. a schedule of meetings with officials and visits to establishments or facilities, including unannounced 
visits, as appropriate; and 
3.7. provisions for respect of commercial confidentiality and avoidance of conflicts of interest. 
4. Opening Meeting 
An opening meeting should be held between representatives of both Parties. At this meeting the auditor will' 
review the audit plan and confirm that adequate resources and documentation are available and all necessary 
arrangements have been made for conducting the audit. 
5. Document Review 
5.1. The document review may include, for example, the following: 
* records concerning compliance programmes; 
* inspection and internal audit reports; 
* documentation concerning corrective actions and sanctions; 
* records of compliance actions taken; 
* sampling plans and their results; 
* documents associated with verification; and 
* regulatory procedures followed by the auditee. 
5.2. In the case of an audit that is subsequent to a determination of equivalence, the document review 
may also consist of a review of relevant changes to the inspection and certification systems since the 
determination of equivalence or since the previous audit. 
5.3. The audilec will co-operate fully with the auditor in the document review process and help to ensure 
that the auditor has access to requested documents and records. 
79 
6. On-site Verification 
6.1. The decision to conduct on-site verification should take into account factors such as the risks 
associated with the animals or animal products concerned, the history of conformity with 
requirements by the industry sector or exporting country, the volume of product produced and 
imported or exported, changes in infrastructure and the nature of the inspection and certification 
systems. 
6.2. On-site verification may involve visits to production and manufacturing establishments, facilities, 
food handling or storage areas and control laboratories to check the accuracy of the information 
contained in the documentary material referred to in 5.1. 
6.3. When checks of establishments or facilities are carried out, the auditee will carry out the check of the 
establishment or facility, following the auditee's usual procedures, and the auditor will generally 
participate as an observer, though is free to check other aspects of performance if deemed necessary. 
6.4. The auditee will co-operate fully with the auditor in the on-site verification process and facilitate the 
auditor's entry into the establishments and facilities that are the subject of the on-site verification. 
7. Follow-up Audit 
A follow-up audit may be conducted to verify the correction of deficiencies identified in a prior audit. 
8. Working Documents 
Working documents may include checklists of elements to evaluate, such as the following: 
* legislation; 
* structure and operations of inspection and certification services; 
* establishment and facility structure, layout, operations and working procedures; 
* health statistics, sampling plans and results; 
* compliance action and procedures; 
* reporting and complaint procedures; and 
* training programmes. 
9. Closing Meeting 
A closing meeting shall be held between representatives of both Parties, including officials responsible for the 
inspection and certification programmes of the auditee. At this meeting the auditor will present the findings of 
the audit. The information should be presented in a clear, concise manner so that the conclusions of the audit 
arc clearly understood. 
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10. Audit Report 
The auditor shall provide the auditee with a draft report of the audit generally within 60 days of the conclusion 
of the audit. To the extent possible, the report shall be presented in a standardised format to be agreed upon by 
the Parties in order to make the approach to audit more uniform, transparent and efficient. The report will 
assess the adequacy of the auditee's enforcement and control programme and identify any deficiencies noted 
during the conduct of the audit. Thereafter, the auditee may within 60 days comment on the draft report and 
shall describe any specific corrective actions that will be taken, preferably with target dates for completion. 
Any comments made by the auditee shall be included in the final report. 
ANNEX VII 
FRONTIER CHECKS 
The Parties recognise the distinction between documentary, identity and physical checks carried out at 
external frontiers on imports of live animals and animal products. 
The Parties further recognise the need to take a systematic approach to carrying out frontier checks. 
Both Parties agree that charges may be made for these checks, in conformity with the relevant provisions of 
Annex C to the SPS Agreement. 
Live Animals 
The Parties may apply physical checks to all consignments of live animals. 
Animal Products 
In setting their physical checking frequencies for imports of animal products, the Parties shall take due 
account of the checks applied by the exporting Party prior to export and the historic performance of products 
imported from the exporting Party. 
The Parties may modulate the;r physical checking frequencies for imports of animal products, notably in the 
light of progress made toward the recognition of equivalence under the consultative process provided for in 
Article 7. 
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ANNEX VIII 
OUTSTANDING ISSUES 
The Parties agree to work to further develop agreed arrangements concerning frontier checks, 
including the frequency of physical checks. 
The Parties agree to work together on their respective arrangements concerning feed additives, 
animal feedingstuffs, medicated feeds and premixes. 
83 
ANNEX IX 
CONTACT POINTS 
The U.S. will send the information provided for in Article 10, and carry out the notifications 
provided for in Article 11, to: 
Agricultural Counsellor 
European Union 
Delegation of the European Commission to the United States 
2300 M Street NW 
Washington DC 20037 
phone: 1 202 862 9560 
fax: 1202 429 1766 
The Community will send the information provided for in Article 10, and carry out the notifications 
provided for in Article 11, to: 
Agricultural Attaché 
Office of Agricultural Affairs 
U.S. Mission of the European Union 
40 Blvd du Regent 
1000 Brussels, Belgium 
phone: 32 2 508 2760 
fax: 32 2 5110918 
84 
ISSN 0254-1475 
COM(97) 566 final 
DOCUMENTS 
EN 11 03 02 05 
Catalogue number : CB-CO-97-615-EN-C 
ISBN 92-78-27561-1 
Office for Official Publications of the European Communities 
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