CELEX: 51997PC0566
Language: en
Date: 1997-11-12
Title: 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

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)
 ---pagebreak---  ---pagebreak---                            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^
 ---pagebreak---  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
 ---pagebreak--- 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
 ---pagebreak--- *^*';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-
 ---pagebreak---                                                               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<*
 ---pagebreak---                         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
                                                                   /
 ---pagebreak---                                              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
 ---pagebreak---   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.
 ---pagebreak---                                                     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.
 ---pagebreak---  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;
 ---pagebreak---                 (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.
 ---pagebreak---       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.
 ---pagebreak---      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.
 ---pagebreak---                                                      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.
 ---pagebreak---                                                  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
 ---pagebreak---                                                      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
 ---pagebreak---                         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
 ---pagebreak---                                                     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
 ---pagebreak---  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
 ---pagebreak--- 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
 ---pagebreak---                                                                                      \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
 ---pagebreak---  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
 ---pagebreak---                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
 ---pagebreak--- 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.
                                                               DOC/         DOI/                USDA/      USDA/   USDA/
                                                               NMFS         FWS        FDA        AMS      APHIS    FSIS
A.    ANIMAL HEALTH
     CERTIFICATIONS
      1. Live animals (including apiculture bees),                                                            X
     embryos, ova, semen, and products of animal origin
                                                                 !
     2. Non-salmonid fish and other non-mammalian                  X                                          X
     aquatic animals, gametes and fertilised ova
     3. Salmonid live fish, gametes, and fertilised ova            X          X                               X
     4. Wild waterfowl                                                        X
     5. Animal feed                                                X                                          X
B.   PUBLIC HEALTH
     CERTIFICATIONS
     1. Meat and poultrv for human
     consumption
                     a) Fresh meat and products from                                                                 X
                     domesticated, farmed and wild cattle,
                     sheep, swine, goats, and equine, and
                     domesticated and farmed chickens,
                    turkeys, ducks, geese, and guinea
                     fowl
                    b) Snakes                                      X                    X
                    c) Fresh meat and products from                                     X                            X
                    species other than above
         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
 ---pagebreak---                                                               DOC/       DOI/             USDA/    USDA/  USDA/
                                                             NMFS        FWS       FDA    AMS     APHIS    FSIS
Public health certifications cont'd
    2. Eggs
                  a) Shell eggs,, hard cooked eggs,                                 X       X
                  ethnic egg delicacies, and imitation
                  egg products
                  b) Liquid, frozen and dried egg                                                           X
                  products
    3. Dairv
                  a) Butter, cheese, frozen desserts, and                           X       X
                  dried milk products
                  b) Fluid milk                                                     X
    4. Seafood
                  a) Fish and fishery products including        X                   X
                  fish oil, reptiles (except snakes), snails
                  and amphibians
                  b) Live fish (including shellfish and         X                   X
                  molluscs)
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
 ---pagebreak---                                       ANNEX III
   LIST OF DISEASES FOR WHICH REGIONAL FREEDOM IS RECOGNISED
                                    Animal diseases
 Foot and mouth disease                             Vesicular stomatitis
 Swine vesicular disease                            Rinderpest
 Peste de petits ruminants                          Contagious bovine pleuropneumonia
 Contagious caprine pleuropneumonia                 Bluetongue
 Sheep and goat pox                                 African horse sickness
African swine fever                                 Classical swine fever
Enterovirus encephalomyelitis                       Fowl plague (avian influenza)
Newcastle Disease                                   Venezuelan Equine Encephalomeyelitis
Pseudorabies/Aujeszky's
                                 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
 ---pagebreak---                                                    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
 ---pagebreak---  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.
 ---pagebreak---   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
 ---pagebreak---                                                     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
 ---pagebreak--- - Commodity                          European Community Exports to the United States                                          United States Exports to the European Community                         |
- Species                     Trade Conditions       Equiv Special Conditions             Actions                     Trade Conditions        Equiv   Special Conditions            Actions
         Animal/Public EC Standards   U.S. Standards (Cat)                                                     U.S. Standards  EC Standards   (Cat)
health
 1. Live animals
 Animal health
                       90/426 Annex 9 CFR 92                                  EC to submit by 1 July 9 CFR                71, 90/426, 92/260,                            U.S. to consider identifying
 - Equidae             DandC                                                  1997,      for    each       EC 75,91           93/195, 93/196,                            horses by passport from
                                                                              laboratory      the      testing                93/197,94/467                              31.12.1997.
                                                                              procedures,           antigens/
                                                                              reagents used, audit/quality                                                               EC to consider withdrawing
                                                                              control program, external                                                                  requirement for isolation
                                                                              control/laboratory approval                                                                before     departure     for
                                                                              programme.                                                                                 permanent imports within 6
                                                                                                                                                                         months of the submission ofI
                                                                              Inter-laboratory      reference                                                            the final report on VS
                                                                              testing and exchange of                                                                    outbreak -
                                                                              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.
                                                                                                                                                                                                    26
 ---pagebreak---   Commodity                           European Community Exports to the United States                                          United States Exports to the European Community
  Species                      Trade Conditions        Equiv  Special Conditions            Actions                     Trade Conditions        Equiv   Special Conditions
         Animal/Public EC Standards    U.S. Standards   (Cat)                                                   U.S. Standards   EC Standards   (Cat)
health
 I. Live animals (cont.) animal health                                                                                                                                                                   j
- Bovine               64/432, 72/462, 9 CFR 92       E                          U.S. to review BSE policy 9 CFR 71, 72, 72/462               E                            EC to review U.S. dossier on I
                       90/425                                                    with respect to high and low 73, 77, 78, 80                                               bluetongue                    1
     Animals                                                                     incidence.                    91
                                                                                                                                                                           U.S. to provide details ofj
                                                                                 U.S. to produce       generic                                                             RB51 brucellosis vaccine, fori
                                                                                 conditions for EC                                                                         review by EC                 fl
                                                                                                                                                                           EC to produce conditions fori
                                                                                                                                                                           U.S.                         1
- Shccp/Goats          91/68           9 CFR 92       E                          U.S. to produce       generic 9 CFR 54, 71, 91/68,97/231     E                            EC to review U.S. dossier onl
                                                                                 conditions for EC             79,77                                                       bluetongue                    |
                                                                                                                                                                           U.S. to submit scrapie!
                                                                                                                                                                           programme     when      final |
                                                                                                                                                                           review is completed. EC to J
                                                                                                                                                                           comment                       1
                                                                                                                                                                           EC to produce conditions fori
                                                                                                                                                                           U.S.                          |
                       64/432, 72/462, 9 CFR 92       E                          U.S. to produce       generic 9 CFR 71, 76, 72/462           E
 • Swine               90/425                                                    conditions for EC             77,78, 85
                                                                                                                                                                           EC to produce conditions fori
                                                                                                                                                                           U.S.
                                                                                                                                                      -
                       92/65            9 CFR 92      NE                                                                       92/65          NE                                 j
 - Dogs and cats                                                                                                                                                              ——   —————-———
                       92/65            9 CFR 92      NE                                                                       92/65          NE
 • "Balai"
     animals                                                                                                                                                                                   i
                                                                                                                                                                                                      27
 ---pagebreak---     - Commodity                            European Community Exports to the United States                                     United States Exports to the European Community                           f
    - Species                       Trade Conditions        Equiv Special Conditions            Actions                 Trade Conditions         Equiv  Special Conditions            Actions             I
             Animal/Public EC Standards     U.S. Standards  (Cat)                                               U.S. Standards   EC Standards     (Cat)
    health
' '      •                —
     2. Live poultry and hatching eggs
     Animal health
                            90/539, 93/342  9 CFR 92                                 U.S. to produce    generic 9 CFR 71, 82, 90/539, 93/432
                                                                                     conditions                 145, 147        96/482,96/483
     3. Semen                                                                                                                                                                                             |
     Animal health
                            88/407           9CFR98        E                         U.S. to produce    generic 9CFR            88/407,94/577   E                          EC to produce conditions to
     - Bovine                                                                        conditions for EC          71,77,78                                                   allow use of new elisa test kill
                                                                                                                                                                           for bluetongue                  |
                                                                                                                                                                           EC to consider allowing |
                                                                                                                                                                           movement between centres I
                                                                                                                                                                           in two approved third |
                                                                                                                                                                           countries                       |
                            92/65            9CFR98        E                         U.S. to produce    generic 9 CFR 71,79     Directive 92/65 NE
      - Sheep/Goats                                                                  conditions for EC
                            90/429           9CFR98        E                         U.S. to produce    generic 9 CFR 71, 78, 90/429,93/199     E                          EC to examine U.S. request!
      • Porcine                                                                      conditions for EC          85                                                         that CSF tests not berequiredI
                                                                                                                                                                           on entry and exit from!
                                                                                                                                                                           centres in countries free ofl
                                                                                                                                                                           the disease.
                             92/65           9CFR 98       NE                                                                   92/65           NE
      - Canine                                                                                                                                                                                  •
                             92/65                         NE                                                                   92/65           NE
      - Feline.
                                                                                                                                                                                                 ,
                                                                                                                                                                                                       28
 ---pagebreak---  - Commodity                           European Community Exports to the United States                     United States Exports to the European Community
 - Species                      Trade Conditions         Equiv Special Conditions   Actions         Trade Conditions       Equiv   Special Conditions   Actions
          Animai/Public EC Standards     U.S. Standards  (Cat)                              U.S. Standards   EC Standards  (Cat)
 health
|U. Equine semen, ova and embryos
  Animal health
                                                                                                                                                                3
                        92/65, 95/307   9 CFR 98        NE                                  9 CFR 71, 75    92/65,96/539  NE
    Semen
                                                                                                                                                                29
 ---pagebreak--- - Commodity                           European Community Exports to the United States                                       United States Exports to the European Community
- Species                      Trade Conditions        Equiv Special Conditions           Actions                    Trade Conditions       Equiv   Special Conditions    Actjons
         Animal/Public EC Standards    U.S. Standards  (Cat)                                                 U.S. Standards   EC Standards   (Cat)
health
 4. Equine semen, ova and embryos - animal health - cont'd
                       92/65,95/294    9 CFR 98       NE                                                     9 CFR 71,75     92/65,96/540  NE
 - Ova
                       92/65, 95/294   9 CFR 98       NE                                                     9 CFR 71, 75    92/65,96/540  NE
 - I-mbryos
 5. Embrvos
 Animal health
                        89/556          9 CFR 98      E                         U.S. to produce      generic 9 CFR 71, 77, 89/556,92/471   E
 - Bovine                                                                       conditions for EC.           78
                                                                         -:
                                                                                U.S. to review suspension of
                                                                                imports from BSE affected
                                                                                countries
                        92/65           9 CFR 98      NE                                                                     92/65         NE
 -Ovine/Caprine
                                                                                                                                                                                    |
                                                                                                                                                                                  30
 ---pagebreak---  Commodity                           European Community Exports to the United States                                                 United States Exports to the European Community
 Species                      Trade Conditions        Equiv      Special Conditions                 Actions                  Trade Conditions         Equiv      Special Conditions      Actions
        Animal/Public EC Standards    U.S. Standards  (Cat)                                                          U.S. Standards   EC Standards    (Cat)
6. Fresh meat
Animal health                                                                                                                                                 •
                      64/432, 72/461, 9 CFR 94       Yes 2  Additional certification for U.S. to review rules on BSE 9 CFR 53 (in 72/462, 82/426     Yes 2  3 month residence.
-Ruminants            72/462                                bovines from BSE affected with respect to high/low the case of an
                                                            countries                    incidence regions           outbreak      of                       Holding     freedom     from
                                                                                                                     exotic disease)                        brucellosis for ovines and
                                                                                                                                                            caprines
                      64/432, 72/461, 9 CFR 94       Yesl                                                            9 CFR 53         72/462, 82/426 Yes 2  3 month residence
•IZquidae             72/462
                      64/432, 72/461, 9 CFR 94       Yesl                                                            9 CFR 53         72/462, 82/426 Yes 2  3 month residence.
-Porcine               72/462
                                                                                                                                                            Holding     freedom     from
                                                            . •                                                                                             brucellosis                            |
                                                                                                                                                                                                 31
 ---pagebreak--- - Commodity                           European Community Exports to the United States                                                     United States Exports to the European Community
- Species                      Trade Conditions        Equiv      Special Conditions                  Actions                      Trade Conditions      Equiv       Special Conditions                 Actions
         Animal/Public EC Standards    U.S. Standards  (Cat)                                                               U.S. Standards   EC Standards (Cat)
health
 6. Fresh meat cont'd
  'ublic health
                       64/433, 96/22   9 CFR 301-381, Yes 3  Establishments     listed in  Equivalency (Yes 2) shall be 9 CFR 301-381, 72/462, 93/158, Yes 3   Establishments listed in      The EC shall evaluate the
                                       416,417               accordance with footnote (7), granted after the U.S. has 416,417              96/22               accordance with footnote (7), U.S. residue programme, and
                (8)
 Ruminants                                                   and fulfilling the relevant   completed verification of                                           and fulfilling the relevant   additional information to be
                                                             provisions of footnote (1).   veterinary delivery systems.                                        provisions of footnotes (2),  submitted by the U.S., to
 Equidae                                                                                   This process shall be                                               (3) (4) and (5).              determine whether it meets
 Porcine                                                                                   completed within 12 months                                                                        the EC level of protection.
                                                                                           of the date of entry into force                                                                   This evaluation shall be
 Ovine                                                                                     of the agreement.                                                                                 completed within 6 months
 Caprine                                                                                                                                                                                     of the entiy into force of this
                                                                                                                                                                                             Agreement
                                                                                                                                                                                             The EC shall evaluate the    he I
                                                                                                                                                                                             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 to evaluate a U.S.I
                                                                                                                                                                                             request, when submitted, onl
                                                                                                                                                                                             the need for continued!
                                                                                                                                                                                             trichinae      testing       of|
                                                                                                                                                                                             horsemcat.            '
                                                                                                                                                                                                                         32
 ---pagebreak--- -Commodity                            European Community Exports to the United States                                                     United States Exports to the European Community
- Species                      Trade Conditions        Equiv      Special Conditions                  Actions                      Trade Conditions        Equiv       Special Conditions                   Actions
         Animal/Public FX Standards    U.S. Standards  (Cat)                                                               U.S. Standards   EC Standards   (Cat)
health
                                                                                                                                                                                                                               -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
                       91/494,94/438    9 CFR 94      Yesl                                                                 9 CFR 53        91/494,93/342 Yesl
 Animal health                                                                                                                             94/984
                        71/118, 96/22, 9 CFR 381      Yes 3  Establishments listed in      Equivalency (Yes 2) shall be 9 CFR 381.1        71/118, 96/22, Yes 3  Establishments listed in       The EC shall evaluate the
 Public health          96/23                                accordance with footnote (7), granted after the U.S. has 381.5                96/23,96/712          accordance with footnote (7),   U.S. residue programme, and
                                                             and fulfilling the relevant   completed verification of                                             and fulfilling the relevant    additional information to be
                                                             provisions of footnote (1).   veterinary delivery systems.                                          provisions of footnotes (2),   submitted by the U.S., to
                                                             Post-mortem inspection to be  This process shall be                                                 (3), (4) and (6).              determine whether it meets
                                                             carried out by official       completed within 12 months                                                                           the EC level of protection.
                                                             inspectors                    of the date of entry into force                                                                      This evaluation shall be
                                                                                           of the agreement.                                                                                    completed within 6 months
                                                                                                                                                                                               of the entry into force of this
                                                                                                                                                                                               Agreement                     '
                                                                                                                                                                                                                              33
 ---pagebreak--- - Commodity                          European Community Exports to the United States                     United States Exports to the European Community
- Species                     Trade Conditions       Equiv Special Conditions     Actions        Trade Conditions      Equiv     Special Conditions              Actions
         Animal/Public FX Standards   U.S. Standards (Cat)                                U.S. Standards  EC Standards  (Cat)
health
 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
 ---pagebreak--- - Commodity                           European Community Exports to the United States                                                United States Exports to the European Community
- Species                      Trade Conditions        Equiv      Special Conditions                 Actions                  Trade Conditions       Equiv       Special Conditions  Actions    I
         Animal/Public EC Standards    U.S. Standards  (Cat)                                                          U.S. Standards   EC Standards  (Cat)
health                                                                                                                                                                                        |
 8. Meat Products
 Animal health
                       64/432, 72/461, 9 CFR 94       Yes 2  Additional certification for U.S. to review rules on BSE 9 CFR 53        72/462,97/221 Yes 2  Derived from meat meeting
 • Red Meat            72/462, 80/215                        bovines from BSE affected with respect to high/low                                            the conditions of point 6
 (ruminants/                                                 countries                    incidence regions                                                (fresh meat).
  equidae)
                       64/432, 72/461, 9 CFR 94       Yesl                                                            9 CFR 53        72/462,97/221 Yes 2  Derived from meat meeting
   Pies.               72/462,80/215                                                                                                                       the conditions of point 6
                                                                                                                                                           (fresh meat).
                       92/118, 72/462, 9 CFR 94       Yesl                                                            9 CFR 53        97/221        Yes 2  Derived from meat meeting
   Poultry             80/215,94/438                                                                                                                       the conditions of point 7
                                                                                                                                                           (poultrymeat).
                       92/495, 92/45    9 CFR 94      Yes 2  Additional certification for U.S. to review rules on BSE                 92/495,92/45  NE
 • Wild game                                                 bovines from BSE affected with respect to high/low                       97/221
 and fanned                                                  countries                    incidence regions
 eame
                                                                                                                                                                                             35
 ---pagebreak--- - Commodity                           European Community Exports to the United States                                                      United States Exports to the European Community
- Species                      Trade Conditions         Equiv      Special Conditions                  Actions                     Trade Conditions      Equiv       Special Conditions                  Actions
         Animal/Public FC Standards    U.S. Standards   (Cat)                                                               U.S. Standards  EC Standards (Cat)
health
 8. Meat Products cont'd
 Public health
                                                              Establishments     listed  in Equivalency (Yes 2)shall be 9 CFR 301-335, 72/462, 77/99, Yes 3    Derived from meat meeting
 Ruminants w           77/99, 96/22    CFR 301-335, Yes 3
                                                              accordance with footnote (7), granted after the U.S. has 354,          381.1- 92/118,96/22       the conditions of point 6
                                                                                                                                                                                             The EC shall evaluate the
                                                                                                                                                                                             U.S. residue programme, and
                                       354,      381.1-
 Equidae                               381.500                and fulfilling the relevant   completed verification of 381.500                                  (fresh meat) and/or 7         additional information to be
                                                              provisions of footnote 1.     veterinary delivery systems.                                       (poultrymeat).                submitted by the U.S., to
 Pigs \                                                                                     This process shall be                                              Establishments listed in      determine whether it meets
 Poultry                                                                                    completed within 12 months                                         accordance with footnote (7), the EC level of protection.
                                                                                            of the date of entry into force                                    and fulfilling the relevant   This evaluation shall be
                                                                                            of the agreement.                                                  provisions of footnotes (2),  completed within 6 months
                                                                                                                                                               (3) and (4).                  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
 ---pagebreak--- - Commodity                            European Community Exports to the United States                                                    United States Exports to the European Community        I
- S pee les .                   Trade Conditions           Equiv      Special Conditions                  Actions                  Trade Conditions        Equiv  Special Conditions    Actions
          Animal/Public EC Standards     U.S. Standards    (Cat)                                                           U.S. Standards   EC Standards   (Cat)
health
 8. Meat Products - public health - cont'd
 Wild came W 77/99, 96/22 FFDCA,         FIFRA, PHSA
                                                          NE     Existing trade conditions                                 FFDCA,          77/99, 92/118, NE
                                                                                                                           FIFRA, PHSA 96/22
                                         21 CFR 70-82,                                                                     21 CFR 70-82,
 Farmed came (8)                         101,        109,
                                         110.3-110.93,
                                                                                                                           101,       109,
                                                                                                                           110.3-110.93,
                                         113, 114, 170-                                                                    113, 114, 170-
                                         189, 510-529,                                                                     189, 510-529,
                                         556                                                                               556
                                         40 CFR 180,                                                                       40 CFR 180,
                                         185                                                                               185
 9. Farmed game meat                                                                                                                                                                             1
 Animal health
                        72/461, 92/118,  9 CFR 94         Yes 2  Additional certification from U.S. to review rules on BSE                 92/118,91/495  NE
                                                                                                                                                                                                  J
 -Deer                  91/495                                   BSE affected countries        with respect to high/low                    97/219
                                                                                               incidence regions
                                                          Yesl
 -Rabbit
                         72/461, 92/118, 9 CFR 94         Yesl                                                                             92/118         NE
 -Porcine                91/495
                         92/118, 72/462, 9 CFR 94         Yesl                                                             9 CFR 94        92/118,97/219  NE
 -Feathered              80/215,94/438
                                                                                                                                                                                                37
 ---pagebreak--- • Commodity                           European Community Exports to the United States                           United States Exports to the European Community
- Species                      Trade Conditions          Equiv      Special Conditions   Actions         Trade Conditions        Equiv  Special Conditions    Actions
         Animal/Public F.C Standards   U.S. Standards    (Cat)                                   U.S. Standards   EC Standards   (Cat)
health
 9. Farmed game meat cont'd
 Public health
 See    footnote   (8) 91/495, 96/22, FFDCA,            NE     Existing trade conditions         FFDCA,          91/495, 96/22, NE
                       97/219          FIFRA, PHSA                                               FIFRA, PHSA 97/219
 for ruminants
                                        21 CFR 70-82,                                            21 CFR 70-82,
                                        101,       109,                                          101,       109,
                                        110.3-110.93,                                            110.3-110.93,
                                        113, 170-189,                                            113, 170-189,
                                        510-529,556                                              510-529,556
                                        40 CFR 180,                                              40 CFR 180,
                                        185                                                      185
                                        9 CFR 301-335,                                           9 CFR 301-335,
                                        352,354                                                  352,354
  10. Wild game meat                                                                                                                                                      ]
  Animal health
                        92/45           9 CFR 94        E                                                         92/45,97/218  NE
  -Deer
                                                                   •
  -Rabbit
                        92/45            9 CFR 94       E                                                         92/45,97/220  NE
  -Porcine
                                                                ,                                                                                                     ,
                                                                                                                                                                        38
 ---pagebreak--- - Commodity                          European Community Exports to the United States                                    United States Exports to the European Community
- Species                     Trade Conditions          Equiv       Special Conditions   Actions ' ' •' i        Trade Conditions       Equiv   Special Conditions   Actions
         Animal/Public EC Standards   U.S. Standards     (Cat)                                          U.S. Standards    EC Standards  (Cat)
health
 10. Wild game meat - animal health - cont'd
                       92/45          9 CFR 94         £                                                                 92/45,97/218  NE
 -Feathered
 Public health
 See footnote      (8) 92/45, 96/22, FFDCA,            NE      Existing trade conditions                 FFDCA,          92/45, 96/22, NE
                       96/23, 97/218, FIFRA, PHSA                                                        FIFRA, PHSA 96/23, 97/218,
 for ruminants
                       97/220         21 CFR 70-82,                                                     21 CFR 70-82, 97/220
                                       101,       109,                                                   101,       109,
                                       110.3-110.93,                                                     110.3-110.93,
                                       170-189, 510-                                                     170-189, 510-
                                      529,556                                                            529, 556
                                      9 CFR 301-335                                                      9 CFR 301-335
                                      40 CFR 180,                                                       40 CFR 180,
                                       185                                                               185
                                                                                                                                                                             39
 ---pagebreak---  Commodity                           European Community Exports to the United States                                                    United States Exports to the European Community
  Species                     Trade Conditions           Equiv      Special Conditions                Actions                    Trade Conditions       Equiv      Special Conditions            Actions
         Animal/Public EC Standards  l U.S. Standards    (Cat)                                                           U.S. Standards   EC Standards  (Cat)
health
11. Fisheries products for human consumption
Animal health
                                       USDI & Title NE                                                                   USDI & Title 91/67            NE
-Fish/fisheries 91/67                  50                                                                                50
                                                                                                                                                                                      EC to evaluate new U.S.
                                                                                                                                                                                      standards if applicable
products
                       91/67           USDI & Title NE                                                                   USDI & Title 91/67            NE
-Bivalve                               50                                                                                50
molluscs/
crustaceans
(excl. live)
 Public health
                       91/493, 96/22, 21 CFR       123, Yes 3  Low Acid Canned         Food U.S. to respond, by 1 July 21 CFR 123, 91/493, 95/328, Yes 3      95/328                  U.S. to inform the EC when
 -Fish/fisheries       96/23           1240                    requirement                  1997,      with     detailed 1240            96/22,96/23                                  the U.S. is ready to have the
 products                                                                                   indication of how the EC                                                                  implementation of          its
                                                                                            request for equivalence for                                                               seafood HACCP Regulation
                                                                                            Low Acid Canned Food can                                                                  reviewed.
                                                                                            be considered.
                                                                                                                                                                                      EC to carry out review,
                                                                                            By May 15, EC to provide                                                                  involving      as necessary
                                                                                            (1) appropriate information                                                               examination of information
                                                                                            and     documentation     on                                                              and documentation to be
                                                                                            procedures for audit and                                                                  provided      by U.S. on
                                                                                            control of implementation                                                                 procedures for audit and
                                                                                            by Member States, and (2)                                                                 control of implementation.
                                                                                            information on application                                                                On-site verification of U.S.
                                                                                            of HACCP systems in                                                                       system to be carried out
                                                                                            Member States.                                                                            within 6 months of U.S.
                                                                                                                                                                                      request.             '
                                                                                                                                                                                                                 40
 ---pagebreak---  - Commodity                           European Community Exports to the United States                                         United States Exports to the European Community                          1
 - .Species                     Trade Conditions       Equiv Special Conditions             Actions                     Trade Conditions       Equiv   Special Conditions             Actions            1
           Animal/Public EC Standards   U.S. Standards (Cat)                                                    U.S. Standards   EC Standards  (Cat)                                                   ~l
1 health
  11. Fisheries products for human consumption - Public Health - cont'd
                                                                                Before 1 September 1997,                                                                  EC      to    indicate    any
  - Fisli/fisheries                                                             U.S. to conduct on-site                                                                   outstanding          problems
  products cont'd                                                               verification of EC system                                                                 following above actions
                                                                                (including visit to EC                                                                    within 45 days of on-site
                                                                                central       offices      and                                                            verification.
                                                                                observation of Commission
                                                                                audits of a number of                                                                     The outcome of the on-site
                                                                                Member States).                                                                           verification to be discussed
                                                                                                                                                                          with      EC.    If    on-site
                                                                                U.S.     to    indicate    any                                                            verification satisfactory, the
                                                                                outstanding           problems                                                            equivalence determination
                                                                                following above actions by                                                                to be finalised, and any
                                                                                15 October 1997.                NMFS                          Yesl                        necessary procedures carried
                                                                                                                Voluntary                                                 out.
                                                                                The outcome of the on-site HACCP based
                                                                                verification to be discussed Program         50                                           "Establishments" do not
                                                                                with      EC.     If    on-site CFR 260                                                   include "brokers or traders".
                                                                                verification satisfactory, the
                                                                                equivalence determination
                                                                                to be finalised, and any
                                                                                necessary procedures carried
                                                                                out.
                                                                                                                                                                                                      41
 ---pagebreak---                                                                                                                                                                                                                 —          1
- Commodity                           European Community Exports to the United States                                                      United States Exports to the European Community
- Species                      Trade Conditions        Equiv       Special Conditions               Actions                         Trade Conditions       Equiv       Special Conditions               Actions
         Animal/Public EC Standards    U.S. Standards  (Cat)                                                               U.S. Standards    EC Standards  (Cat)
health
 11. Fisheries products for human consumption - Public Health - cont'd
                       91/492,         National       Yes 3  I Existing trade conditions EC to supply the raw data         National         91/492        Yes 3  Existing trade conditions Joint       comparison      of
 -Bivalve                              Shellfish                                         used for the scientific           Shellfish                                                       flesh/water testing        for
 molluscs/                             Sanitation                                        assessment on flesh/water         Sanitation                                                      classification of production
                                        Programme                                        testing. U.S. shall respond to    Programme                                                       areas.
 crustaceans                                                                             results       of       scientific
  excl. live)                                                                            assessment within 90 days of                                                                      U.S.. to inform the EC when
                                                                                         receipts of raw data.                                                                             the U.S. is ready to have the
                                                                                                                                                                                           implementation of           its
                                                                                         By May 15, EC to provide                                                                          seafood HACCP Regulation,
                                                                                         (1) appropriate information                                                                       reviewed.
                                                                                         and      documentation ' o n
                                                                                         procedures for audit and                                                                          EC to carry out review,
                                                                                         control of implementation                                                                         involving      as necessary
                                                                                         by Member States, and (2)                                                                         examination of information
                                                                                         information on application                                                                        and documentation to be
                                                                                         of HACCP systems in                                                                               provided by U.S. on
                                                                                         Member States.                                                                                    procedures for audit and
                                                                                                                                                                                           control of implementation.
                                                                                         Before 1 September 1997,                                                                          On-site verification of U.S.
                                                                                         U.S. to conduct on-sitt                                                                           system to be carried out
                                                                                         verification of EC system                                                                         within 6 months of U.S.
                                                                                         (including visit to EC                                                                            request.
                                                                                         central        offices      and
                                                                                         observation of Commission                                                                         EC       to    indicate   any
                                                                                         audits of a number of                                                                             outstanding          problems
                                                                                          Member States).                                                                                  following above ' actions
                                                                                                                                                                                           within 45 days of on-site
                                                                                          U.S. to        indicate any                                                                      verification.
                                                                                         outstanding            problems
                                                                                          following above actions by
                                                                                          15 October 1997.
                                                                                                                                                                                                                      42
 ---pagebreak--- - Commodity                          European Community Exports to the United States                                            Umted States Exports to the European Community                          1
- Species                     Trade Conditions          Equiv Special Conditions            Actions                      Trade Conditions        Equiv Special Conditions             Actions
         Animal/Public EC Standards   U.S. Standards    (Cat)                                                   U.S. Standards    EC Standards   (Cat)
health
                                                                                                                                                                                    =====
 11. Fisheries products for human consumption - Public Health - cont'd
                                                                                 The outcome of the on-site                                                               The outcome of the on-site
 -Bivalve                                                                        verification to be discussed                                                             verification to be discussed
 molluscs/                                                                       with      EC.    If    on-site                                                           with      EC.     If   on-site
                                                                                 verification satisfactory, the                                                           verification satisfactory, the
 crustaceans                                                                     equivalence determination                                                                equivalence determination
 (excl.        Live)                                                             to be finalised, and any                                                                 to be finalised, and any
                                                                                 necessary procedures carried                                                             necessary procedures carried
 cont'd                                                                          out.                                                                                     out.
                                                                                                                                                                          "Establishments" do not
                                                                                                                                                                           include "brokers or traders".
  - Aquaculture        91/493, 96/22, National         NE                                                       National         91/493, 96/22, NE
                        96/23          Shellfish                                                                Shellfish        96/23
  animals and                          Sanitation                                                               Sanitation
                                       Programme,                                                               Programme,
  products                             FFDCA,                                                                   FFDCA,
                                       FIFRA, PHSA,                                                             FIFRA, PHSA,
                                       21 CFR 110.3-                                                            21 CFR 110.3-
                                       110.93,    123,                                                          110.93,     123,
                                       1240, DVM                                                                1240, DVM
  12. Live fish / shellfish and gametes
                                                       NE                                                                        91/67          NE
  Animal health 91/67
                                                                                                                                                                                                      43
 ---pagebreak--- - Commodity                            European Commumty Exports to the United States                                                      United States Exports to the European Community
- Species                       Trade Conditions        Equiv      Special Conditions                   Actions                     Trade Conditions       Equiv       Special Conditions                Actions
         Animal/Public IZC Standards    U.S. Standards  (Cat)                                                               U.S. Standards   EC Standards  (Cat)
health
113. Milk and milk based products for human consumption
  Animal health
                        64/432, 92/46    9 CFR 94      Yes 2  Certification to UHT for        U.S. to review whether 9 CFR 77,78            92/46,95/343  Yes 2  TB         and        Brucella EC to review U.S. TB and
  -Cattle                                                     FMD affected regions            double         pasteurisation                                      requirements for     non-heat Brucella programmes
  including                                                                                   acceptable.                                                        treated
                                                              For     non-FMD        affected
  buffalo                                                     countries/regions a certificate
                                                              of origin is required.
  -Sheep
  -Goats
                                                                                                                         t
i
                                                                                                                                                                                                                      44
 ---pagebreak--- - Commodity                          European Community Exports to the United States                                                   United States Exports to the European Commumty
- Species                     Trade Conditions          Equiv      Special Conditions               Actions                     Trade Conditions        Equiv       Special Conditions                Actions
         Animal/Public EC Standards    U.S. Standards   (Cat)                                                           U.S. Standards   EC Standards   (Cat)
health
  3. Milk and milk based products for human consumption cont'd
  'ubiic health
                       92/46, 94/71, FFDCA,FIFRA, Yes 3       Existing trade conditions. U.S. to review Import Milk     FFDCA,          92/46, 94/71, Yes 3   EC requirements for somatic U.S. to consider including
 •UHT-Milk/            95/340, 95/342, PHSA 21 CFR                                       Act.                           FIFRA, PHSA     95/340, 95/342,       cell and plate counts       HACCP system in dairy
sterilised             96/22, 96/23, 70-82,        108,                                                                 21 CFR 70-82,   95/343, 96/22,        Certification as per 95/343 products
                       97/115, 91/180, 110.3-110.93,                                     U.S. to respond, by 1 July     108,     110.3- 96723, 97/115,
 Milk                  92/608, 92/118, 113, 131, 172,                                    1997, with detailed indication 110.93,    113, 91/180, 92/608,                                   Joint       assessment       of
                       96/90           184, 510-520,                                     of how the EC request for 131, 172, 184,       92/118,96/90                                      laboratories to be completed
                                       556,      1210,                                   equivalence for Low Acid 510-520, 556,
                                       1240                                              Canned      Food     can    be 1210,1240                                                         Discussions on somatic cells
                                       40 CFR 180,                                       considered.                    40 CFR 180,                                                       and plate counts to continue
                                       185                                                                              185
                                                                                         Joint      assessment       of                                                                   U.S. to provide appropriate
                                                                                         laboratories to be completed                                                                     information                and
                                                                                                                                                                                          documentation               on
                                                                                         EC to provide appropriate                                                                        procedures for audit and
                                                                                         information               and                                                                    control of implementation.
                                                                                         documentation               on                                                                   EC to review information
                                                                                         procedures for audit and                                                                         provided, and to cany out
                                                                                         control of implementation                                                                        on-site verification of U.S.
                                                                                         by Member States. U.S. to                                                                        system.
                                                                                         review             information
                                                                                         provided, and to carry out                                                                       The outcome of the on-site
                                                                                         on-site verification of EC                                                                        verification to be discussed
                                                                                         system.                                                                                           with U.S..        If on-site
                                                                                                                                                                                           verification satisfactory, the
                                                                                                                                                                                           equivalence determination
                                                                                                                                                                                           to be finalised, and any
                                                                                                                                                                                           necessary procedures carried
                                                                                                                                                                                          out
                                                                                                                                                                                                                       45
 ---pagebreak--- 1
j-Commodity                            European Community Exports to the United States                                                            United States Exports to the European Community
 -Species                       Trade Conditions            Equiv      Special Conditions                    Actions                      Trade Conditions         Equiv       Special Conditions                Actions
i-       Animal/Public EC Standards      U.S. Standards     (Cat)                                                                 U.S. Standards   EC Standards    (Cat)
! health
l .
    3. Milk and milk based products for human consumption - public health - cont'd
                                                                                                 The outcome of the on-site
  •UHT-Miik/                                                                                     verification to be discussed
  sterilised                                                                                     with      EC.      If    on-site
                                                                                                 verification satisfactory, the
  Milk cont'd                                                                                    equivalence determination
                                                                                                 to be finalised, and any
                                                                                                 necessary procedures carried
                                                                                                 out.
                                          Pasteurised                                            The U.S. to respond, by 1        Pasteurised
                                          Milk Ordinance                                         July 1997, with a detailed       Milk Ordinance
                                          for Grade A                                            indication of how the EC         for Grade A
                                          Products and                                           request for equivalence to       Products     and
                                          related                                                "Grade       A"       can    be  related
                                          documents                                              considered, and thus to          documents
                                                                                                 allow the possibility of
                                                                                                 export of such products to
                                                                                                 the U.S..
                       92/46,     94/71,  FFDCA,           Yes 3  Existing trade conditions      V.S. to review Import Milk       FFDCA,           92/46, 94/71, Yes 3   EC requirements for somatic U.S. to consider including
  -Pasteurised         95/340,   95/342,  FIFRA, PHSA                                            Act.                             FIFRA, PHSA      95/340, 95/342,       cell and plate counts        HACCP system in dairy
   products            96/22,     96/23,  21 CFR 70-82,           E coli      requirement   (for                                  21 CFR 70-82,    95/343, 96/22,        Certification as per 95/343  products
                        97/115,  91/180, .108,      110.3-        cheeses)                        Discussions on differences in 108,        110.3- 96/23, 97/115,
                        92/608,  92/118,   110.93,    113,                                        finished product criteria for E 110.93,     113, 91/180, 92/608,                                    Joint      assessment       of
                        96/90              131, 133, 135,                                        coli to continue.                131, 133, 135,   92/118,96/90                                       laboratories to be completed
                                           172, 184, 510-                                                                          172, 184, 510-
                                          520,        556,                                       Joint       assessment        of 520,        556,                                                    Discussions on somatic cells
                                           1210,1240                                              laboratories to be completed 1210,1240                                                             and plate counts to continue
                                          40 CFR 180,                                                                             40 CFR 180,
                                           185                                                                                    185.                                                               U.S. to provide appropriate
                                                                                                                                                                                                     information           , and
                                                                                                                                                                                                     documentation               on
                                                                                                                                                                                                     procedures for audit and
                                                                                                                                                                                                     control of implementation
                                                                                                                                                                                                                                 46
 ---pagebreak--- - Commodity                          European Commumty Exports to the United States                                             United States Exports to the European Community                         1
- Species                     Trade Conditions         Equiv Special Conditions            Actions                     , Trade Conditions      Equiv    Special Conditions            Actions
         Animal/Public EC Standards   U.S. Standards   (Cat)                                                    U.S. Standards    EC Standards (Cat)
health
 13. Milk and milk based products for human consumption - public health - cont'd
                                                                                EC to provide appropriate                                                                  EC to review information
 -Pasteurised                                                                   information                and                                                             provided, and to cany out
 products cont'd                                                                documentation               on                                                             on-site verification of U.S.
                                                                                procedures for audit and                                                                   system.
                                                                                control of implementation
                                                                                by Member States                                                                           The outcome of the on-site
                                                                                                                                                                           verification to be discussed
                                                                                U.S. to review information                                                                 with U.S.. If on-site
                                                                                provided, and to carry out                                                                 verification satisfactory, the
                                                                                on-site verification of EC                                                                 equivalence determination
                                                                                system.                                                                                    to be finalised, and any
                                                                                                                                                                           necessary procedures carried
                                                                                The outcome of the on-site                                                                 out
                                                                                verification to be discussed
                                                                                with      EC.    If     on-site
                                                                                verification satisfactory, the
                                                                                equivalence determination
                                                                                to be finalised, and any
                                                                                necessary procedures carried
                                                                                out
                                       Pasteurised                              The U.S. to respond, by 1       Pasteurised
                                       Milk Ordinance                           July 1997, with a detailed      Milk Ordinance
                                       for Grade A                              indication of how the EC        for Grade A
                                       Products    and                          request for equivalence to      Products     and
                                       related                                  "Grade      A"      can     be  related
                                       documents                                considered, and thus to         documents
                                                                                allow the possibility of
                                                                                export of such products to
                                                                                the U.S..
                                                                                                                                                                                                       47
 ---pagebreak--- - Commodity                          European Community Exports to the United States                                                                      ,                                                                   u
                                                                                                                                         United States Exports to the European Community
- Species                     Trade Conditions         Equiv      Special Conditions                  Actions                     Trade Conditions          Equiv      Special Conditions                  Actions
         Animal/Public EC Standards    U.S. Standards  (Cat)                                                              U.S. Standards   EC Standards     (Cat)
health
 13. Milk and milk based products for human consumption - public health - cont'd
                       91756;—547717 WUCK,            YêsT   Compliance with E coli Discussions on ditterences in         FFDCA,          92/46, 94/71, YêsT      Compliance        with     EC TTS^oconsiaePTncluding J
 -Not                  95/340, 95/342, FIFRA, PHSA           requirement (for cheeses)    finished product criteria for E FIFRA, PHSA     95/340, 95/342,         requirements for somatic celt HACCP system in dairy |
 Pasteurised           97/115, 91/180, 21 CFR 70-82,                                      coli to continue.               21 CFR 70*82,   95/343, 97/115,         and plate counts              products.
                       92/608, 92/118, 108, 110, 113,                                                                     108, 110, 113,  91/180, 92/608,         Certification as per 95/343
 (raw or               96/22, 96/23, 133, 172, 184,                                       Joint       assessment       of 133, 172, 184,  92/118, 96/22,                                        Joint      assessment       of
 thermiscd)            96/90           185, 510-520,
                                                                                          laboratories to be completed    185, 510-520,   96/23, 96/90                                          laboratories to be completed.
                                                                                                                          556,1240
                                       556, 1240
                                       40 CFR 180                                         EC to provide appropriate 40 CFR 180                                                                  Discussions on somatic cells
                                                                                          information                 and                                                                       and plate counts to continue.
                                                                                          documentation                on
                                                                                          procedures for audit and                                                                              U.S. to provide appropriate
                                                                                          control of implementation                                                                             information               and
                                                                                          by Member States.                                                                                     documentation               on
                                                                                                                                                                                                procedures for audit and
                                                                                          U.S. to review information                                                                            control                      of
                                                                                          provided, and to carry out                                                                            implementation.EC            to
                                                                                          on-site verification of EC                                                                            review             information
                                                                                          system. The outcome of the                                                                            provided, and to carry out
                                                                                          on-site verification to be                                                                            on-site verification of U.S.
                                                                                          discussed with EC. If on-site                                                                         system.
                                                                                          verification satisfactory, the
                                                                                          equivalence determination                                                                             The outcome of the on-site
                                                                                          to be finalised, and any                                                                              verification to be discussed
                                                                                          necessary procedures carried                                                                          with     VS..      If on-site
                                                                                          out.                                                                                                  verification satisfactory, the
                                                                                                                                                                                                equivalence determination
                                                              Prohibition on products not The U.S. to consider a                                                                                to be finalised, and any
                                                              matured for more than 60     dossier, to be submitted by                                                                          necessary procedures carried
                                                              days at temperature above    the EC, for cheese not                                                                               out
                                                              35°F (+2°C).                 matured for more than 60
                                                                                           days, and thus to allow the
                                                                                           possibility of export of such
                                                                                           products to the U.S..
                                                                                                                                                                                                                              •J
                                                                                                                                                                                                                            48
 ---pagebreak--- - Commodity                          European Community Exports to the United States                                                     United States Exports to the European Community        1
- Species                     Trade Conditions        Equiv       Special Conditions                     Actions                  Trade Conditions        Equiv  Special Conditions    Actions   |
         Animal/Public EC Standards   U.S. Standards  (Cat)                                                               U.S. Standards   EC Standards   (Cat)
health
 14. Milk and milk based products not for human consumption                                                                                                                                      |
Animal health
                       92/118,64/432 9 CFR 94.16     Yes 2  For      non-FMD        affected U.S. to review if double 9 CFR 77,78         92/118, 95/341 NE
 -Cattle                                                    regions, a certificate of origin pasteurisation of products
 including                                                  is required.                     from FMD affected regions is
                                                            For FMD affected regions,        acceptable.
 buffalo                                                    certification to UHT
 -Sheep                                                                                                                                                          -
 -Goats
 All- pasteurised
 or UHT or
 Sterilised
                       92/118          9 CFR 94.16   NE                                                                   9 CFR 77, 78    92/118         NE
 -Unpasteurised
 colostrum for
 pharmaceu-
 tical use (l0)
                                                                                                                                                                                               49
 ---pagebreak--- - Commodity                            European Community Exports to the United States                                                  United States Exports to the European Community                                    1
- Species                       Trade Conditions        Equiv      Special Conditions                   Actions                  Trade Conditions       Equiv       Special Conditions                 Actions              1
          Animal/Public EC Standards    U.S. Standards  (Cat)                                                            U.S. Standards   EC Standards  (Cat)
health .
                                                                                                                                                                                            ^^=S=aBS=SSS=SSB^xJ
 15. Minced meat
 Animal health
 - Ruminants            64/432, 72/461, 9 CFR 94       Yes 2  Additional certification for U.S. to review rules on BSE                   72/462        NE
                        72/462                                bovines from BSE affected with respect to high/low
                                                              countries.                    incidence regions.
                        64/432, 72/461, 9 CFR 94       Yesl                                                                              72/462        NE
 - Pigs                 72/462
                                                                                                                                                                                                                       •
 Public health
        .         VS)— 94/65             9 CFR 301-381 Yes 3  Establishments     listed in  Equivalency shall be granted 9 CFR 301-381 94/65,97/29     Yes 3  Derived from meat meeting The EC shall evaluate the
 Ruminants                                                    accordance with footnote (7), after the U.S. has completed                                      the conditions of point 6 U.S. residue programme, and
                                                              and fulfilling the relevant   verification of veterinary                                        (fresh meat).                 additional information to be
 Pigs                                                         provisions of footnote (1).   delivery     systems.   This                                                                    submitted by the U.S., to
                                                                                            process shall be completed                                        Establishments    listed in determine whether it meets
                                                                                            within 12 months of the date                                      accordance with footnote (7), the EC level of protection.
                                                                                            of entry into force of the                                        and fulfilling the relevant This evaluation shall be
                                                                                            agreement.                                                        provisions of footnotes (2), completed within 6 months
                                                                                                                                                              (3) and (4).                  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
 ---pagebreak--- - Commodity                           European Community Exports to the United States                                                 United States Exports to the European Community                          1
- Species                      Trade Conditions         Equiv     Special Conditions                  Actions                  Trade Conditions         Equiv Special Conditions            Actions             I
         Animal/Public EC Standards     U.S. Standards  (Cat)                                                          U.S. Standards   EC Standards    (Cat)                                                   1
health
 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                                                                                                                                                                                                  I
                       64/432, 72/461,  9 CFR 94       Yes 2  Additional certification for U.S. to review rules on BSE                 72/462          NE
 -Ruminants             72/462                                bovines from BSE affected with respect to high/low
                                                              countries.                   incidence regions.
 -Equidae
                        64/432, 72/461, 9 CFR 94       Yesl                                                                            72/462          NE
 -Pigs                  72/462
                        92/118, 72/462, 9 CFR 94       Yesl                                                                            91/494, 93/342, NE
  -Poultry / Wild       80/215,94/438                                                                                                  94/984
  game / Fanned
  game
                                                                                                                                                                                                             51
 ---pagebreak---    •
- Commodity                          European Community Exports to the United States                                                    United States Exports to the European Community                                      I
- Species                     Trade Conditions        Equiv       Special Conditions                    Actions                  Trade Conditions       Equiv       Special Conditions                   Actions
         Animal/Public EC Standards   U.S. Standards  (Cat)                                                              U.S. Standards   EC Standards  (Cat)
health
 16. Meat preparations cont'd
 Public health
 Ruminants (t>> 94/65                 9 CFR 301-381  Yes 2/3 Establishments     listed   in
                                                             accordance with footnote (7),
                                                                                            Equivalency shall be granted 9 CFR 301-381 94/65,97/29
                                                                                            after the U.S. has completed
                                                                                                                                                       Yes 3  Derived from meat meeting
                                                                                                                                                              the conditions of point 6
                                                                                                                                                                                             The EC shall evaluate the
                                                                                                                                                                                             U.S. residue programme, and
 Equidae                                                     and fulfilling the relevant    verification of veterinary                                        (fresh meat) and/or 7          additional information to be
                                                             provisions of footnote (1).    delivery     systems.   This                                      (poultrymeat).                 submitted by the U.S., to
 Pigs                                                                                       process shall be completed                                                                       determine whether it meets
 Poultry                                                                                    within 12 months of the date                                      Establishments listed in       the EC level of protection.
                                                                                            of entry into force of the                                        accordance with footnote (7),  This evaluation shall be
                                                                                            agreement.                                                        and fulfilling the relevant    completed within 6 months
                                                                                                                                                              provisions ' of footnotes (2), of the entry into force of this
                                                                                                                                                              (3) and (4).                   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
 ---pagebreak---                                                                                                                                                                                                                               1
- Commodity                           European Community Exports to the United States                                                          United States Exports to the European Community
- Species                      Trade Conditions          Equiv           Special Conditions                   Actions                   Trade Conditions         Equiv     Special Conditions                 Actions
         Animal/Public EC Standards     U.S. Standards    (Cat)                                                                 U.S. Standards   EC Standards    (Cat)
health
                                                                                                                                                                                                                        1    -,
 16. Meat preparations - public health - cont'd
 Wild name W 94/65                     FIFRA,
                                        FFDCA, PHSA
                                                        NE        Existing trade conditions                                     FIFRA,
                                                                                                                                FFDCA, PHSA
                                                                                                                                                94/65           NE
                                        21 CFR 70-82,                                                                           21 CFR 70-82,
  :                (S)                  101,       109,                                                                         101,       109,
   armed game                                                                                                                   110.3-110.93,
                                        110.3-110.93,
                                        113, 170-189,                                                                           113, 170-189,
                                        510-529,556                                                                             510-529,556
                                        40 CFR 180,                                                                             40 CFR 180,
                                        185                                                                                     185
                   —-—i                               "         ' '                                                                               i      i    .   n    i i    ,, .-  .i —     — _ • _ . — _ i  _ — —      *""~"3
 17. Animal casings for human consumption                                                                                                                                                                                       |
 Animal health
 -Cattle                92/118, 64/432, 9 CFR 96        Yes 2       Non-comminglement         (see U.S. to review rules on BSE                  92/118          NE
                        72/461,72/462                               footnote 9).                   with respect to high/low                     94/187
                                                                                                   incidence regions.
                                                                    No       trade allowed for U.S. to review 94.8(a)(i)(v)
                                                                    countries affected by BSE.     of     CFR       for    non-
                                                                                                   comminglement
                        92/118, 64/432, 9 CFR 96         Yes 2      Non-comminglement         (see U.S. to review 94.8(a)(i)(v)                 92/118          NE
 -Pigs                  72/461,72/462                               footnote 9).                   of     CFR       for    non-                 94/187
                                                                                                   comminglement.
                                                                    Certification    attesting to
                                                                    process and origin for casings
                                                                    originating in ASF free                                                                                                                           •
                                                                    countries/regions          but
                                                                    processed in ASF affected
                                                                     country/region.
                                                                                                                                                                                                                           53
 ---pagebreak--- 1
 - Commodity                          European Community Exports to the United States                                                     United States Exports to the European Commumty        1
 - Species                     Trade Conditions           Equiv      Special Conditions                 Actions                    Trade Conditions          Equiv Special Conditions  Actions   1
          Animal/Public EC Standards    U.S. Standards    (Cat)                                                            U.S. Standards   EC Standards     (Cat)
 health
  17. Animal casings for human consumption - animal health - cont'd                                                                                                                             1
                        92/118, 64/432, 9 CFR 96         Yes 2  Non-comminglement        (see U.S. to review 94.8(a)(i)(v)                 92/118           NE
  •Sheep                72/461,72/462                           footnote 9).                  of     CFR      for    non-                  94/187
  •Goats                                                                                      comminglement.
                                                                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.
                        77/99           FFDCA,           NE                                                                FFDCA,          77/99, 92/118 NE
  Public health                         FIFRA, PHSA                                                                        FIFRA, PHSA     Draft Decision
                                        21 CFR 70-82,                                                                      21 .CFR 70-82,  notified      to
                                        101,        109,                                                                   101,       109, WTO
                                        110.3-110.93,                                                                      110.3-110.93,
                                        113, 114, 170-                                                                     113, 114, 170-
                                         189, 510-529,                                                                     189, 510-529,
                                        556 40 CFR                                                                         556 40 CFR
                                         180,185                                                                           180,185
                                                                                                                                                                                               54
 ---pagebreak--- 1
  - Commodity                           European Community Exports to the United States                                                    United States Exports to the European Community           1
  - Species                      Trade Conditions        Equiv       Special Conditions                   Actions                   Trade Conditions       Equiv   Special Conditions    Actions     1
           Animal/Public T;C Standards   U.S. Standards  (Cat)                                                              U.S. Standards   EC Standards  (Cat)
  health
i
   18. Animal casings not for human consumption                                                                                                                                                       |
  Animal health                                                                                                                                                                                       1
                         92/118,64/432   9 CFR 96       Yes 2  Non-comminglement         (sec U.S. to review rules on BSE                   92/118        NE
   •Cattle
                         72/461,72/462                         footnote 9).                    with respect to high/low                     94/1^7
                                                                                               incidence regions.
                                                               No trade        allowed     for
                                                               countries affected by BSE       U.S. to review 94.8(a)(i)(v)
                                                                                               of     CFR       for   non-
                                                                                               comminglement
                         92/118,64/4327 9 CFR 96        Yes 2  Non-comminglement         (see U.S. to review 94.8(a)(i)(v)                  92/118        NE
   -Pigs                 2/461,72/462                          footnote 9).                    of     CFR       for   non-                  94/187
                                                                                               comminglement
                                                               Certification    attesting to
                                                               process and origin for casings
                                                               originating in ASF free
                                                               countries/regions          but
                                                               processed in ASF affected
                                                               country/region.
                         92/118,64/4327 9 CFR 96        Yes 2  Non-comminglement         (see U.S. to review 94.8(a)(i)(v)                  92/118        NE
   -Sheep                2/461,72/462                          footnote 9).                    of     CFR       for   non-                  94/187
   -Goats                                                                                      comminglement
                                                               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.
                                                                                                                                                                                                 '•
                                                                                                                                                                                                    55
 ---pagebreak---    - Commodity                            European Community Exports to the United States                                              United States Exports to the European Community
   - Species                       Trade Conditions          Equiv      Special Conditions                Actions               Trade Conditions        Equiv       Special Conditions                   Actions
   -         Animal/Public HC Standards    U.S. Standards    (Cat)                                                      U.S. Standards   EC Standards   (Cat)
ij health
.!
    19. Hides and skins                                                                                                                        -                                             •                          1
    Animal health
    -Cattle                92/118, 72/461, 9 CFR 95.5, Yesl                                                                             92/118        E                                      EC to identify basis fori
                           72/462          95.6                                                                                         97/168                                               salting requirement          |
    -Sheep
    -Goats
  !   TV
  -Pigs
  120. Canned petfood containing high/low risk material
                           92/118          9 CFR 94,95      Yes 2  Special rules for BSE U.S. to review rules on BSE FFDCA, FIFRA 92/118                                                     EC to examine U.S. claim to |
          Containing                                               countries. Shelf stable for with respect to high/low 21 CFR 110.3- 94/309
                           90/667           FFDCA, FIFRA                                                                                                                                     be BSE free.
    mammalian              92/562           21 CFR 110.3-          remainder.                  incidence regions.       110.93,    507- 96/449
                                            110.93,   507-                                                              509, 570, 573- 97/199                                                EC to consider alternative!
   .material                                                                                                            589                                                                  guarantees for mammalian
                                            509, 570, 573-
                                            589                                                                                                                                              material, including U.S.
                                                                                                                                                                                             proposal to remove all risk
                                                                                                                                                                                             material of known U.S. TSE
                                                                                                                                                                                             species from petfood.
                           92/118           99 CFR 94,95 Yes 2     Shelf stable for remainder.                          FFDCA, FIFRA    92/118                Establishments shall have
          Containing                        FFDCA, FIFRA                                                                21 CFR 110.3-   94/309                been validated by the U.S. for
                           90/667
    only            non-   92/562           21 CFR 110.3-                                                               110.93,    507- 96/449                alternative heat treatment
                                            110.93,    507-                                                             509, 570, 573-  97/199                including 30 day freedom
     mammalian                              509, 570, 573-                                                              589                                   from Clostridia
     material                               589
                                                                                                                                                                                                                     56
 ---pagebreak--- - Commodity                          European Community Exports to the United States                                                    United States Exports to the European Community                1
- Species                     Trade Conditions         Equiv      Special Conditions                Actions                      Trade Conditions      Equiv         Special Conditions       Actions
         Animal/Public EC Standards   U.S. Standards   (Cat)                                                             U.S. Standards   EC Standards (Cat)                                           -
health
21. Canned petfood containing only low risk material
                                         CFR 94, 95 Yes 2    Special rules for       BSE U.S. to review rules on BSE FFDCA, FIFRA 92/118,94/309
       Containing 92/118,90/667 9FFDCA,        FIFRA         countries. Shelf stable for with respect to high/low 21 CFR 110.3- 96/449,97/199
 mammalian                            21 CFR 110.3-          remainder.                  incidence regions               110.93,    507-
                                       110.93, 507-                                                                      509, 570, 573-
 material                             509, 570, 573-                                                                     589
                                      589
                       92/118,90/667  9 CFR 94, 95    Yes 2  Shelf stable.                                               FFDCA, FIFRA 92/118,94/309           Establishments shall have
 - . Containing                       FFDCA, FIFRA                                                                       21 CFR 110.3- 96/449,97/199          been validated by the U.S. for
 only          non-                   21 CFR 110.3-                                                                      110.93,    507-                      alternative heat     treatment
                                       110.93,   507-                                                                    509, 570, 573-                       including 30 day freedom
 mammalian '                           509, 570, 573-                                                                    589                                  from Clostridia
 material                              589
 22. Dry and semi moist petfood containing only low risk material
                       92/118          9 CFR 94, 95   Yes 2  Restrictions    for     BSE U.S. to examine EC 90° core     FFDCA, FIFRA 92/118,94/309          Î Establishments shall have
                       94/309          FFDCA, FIFRA          countries                   temperature requirement as      21 CFR 110.3- 96/449,97/199          been validated by the U.S. for
                                       21 CFR 110.3-                                     providing            sufficient 110.93,    507-                       alternative heat     treatment
                                       110.93, 507-                                      guarantees against FMD,         509, 570, 573-                        including 30 day freedom
                                       509, 570, 573-                                    CSF,SVD,ASFandND.               589                                   from Clostridia
                                       589                                               U.S. to review rules on BSE
                                                                                                                                                                                                      57
 ---pagebreak--- 1
  - Commodity                               European Community Exports to the United States                                                         United States Exports to the European Community                                 j
  - Species                          Trade Conditions            Equiv        Special Conditions                 Actions                     Trade Conditions      Equiv       Special Conditions                  Actions     ,    8
           /\ninial/Ptiblic EC Standards      U.S. Standards      (Cat)                                                              U.S. Standards   EC Standards (Cat)
  health
<       .
123. Dry and semi moist petfood containing high/low risk material
1                           H  -,   — '      1            - .  1..   ~  1 ~  . . . .      >•      ~~^ 1.
                              92/118,94/309   9 CFR 94, 95      Yes 2    Restrictions    for     BSE U.S. to examine EC 90° C        FFDCA, FIFRA 92/118,94/344                                         EC to examine U.S. claim to
          Contain inc                         FFDCA, FIFRA               countries                    core temperature requirement   21 CFR 110.3- 96/449,97/199                                        be BSE free.
   ma m mal i an                              21 CFR 110.3-                                           as     providing    sufficient 110.93,    507-
                                               110.93,   507-                                         guarantees against FMD,        509, 570, 573-                                                     EC to consider alternative
   ma terial                                  509, 570, 573-                                          CSF.SVD.ASFandND.              589                                                                guarantees for mammalian
                                               589                                                                                                                                                      material, including U.S.
                                                                                                      U.S. to review rules on BSE                                                                       proposal to remove all risk
                                                                                                      with respect to high/low                                                                          material of known U.S. TSE
                                                                                                      incidence regions.                                                                                species from petfood.
                              92/118,94/309    9 CFR 94, 95     Yesl                                  U.S. to examine EC 90° C       FFDCA, FIFRA 92/118,94/344          Establishments shall have
          Containing                           FFDCA, FIFRA                                           core temperature requirement   21 CFR 110.3- 97/199                been validated by the V.S. for
   only             non-                       21 CFR 110.3-                                          as     providing    sufficient 110.93,    507-                     alternative heat     treatment
                                               110.93,    507-                                        guarantees against ND.         509, 570, 573-                      including 30 day freedom
   mammalian                                   509, 570, 573-                                                                        589                                 from Clostridia
   material                                    589
                                                                                                                                                                                                                                 58
 ---pagebreak--- - Commodity                           European Community Exports to the United States                                                  United States Exports to the European Community                       J
- Species                      Trade Conditions           Equiv      Special Conditions                Actions                  Trade Conditions          Equiv Special Conditions           Actions         1
         Animal/Public EC Standards    U.S. Standards     (Cat)                                                         U.S. Standards   EC Standards     (Cat)
health
24. Bones and bone products for human consumption ("other products" as defined in 77/99/EEC)
 Animal health
                                        9 CFR 95         Yes 2  Restrictions    for     BSE U.S. to review rules on BSE                  72/462          NE
 Fresh         meat 64/432
                       72/461                                   countries.                  with respect to high/low                     97/221
 (ruminants,           80/215                                                               incidence regions.
                       72/462
 horses, pigs)
                                        9 CFR 95         Yes 2  Restrictions    for     BSE U.S. to review rules on BSE                  91/495          NE
 Farmed game - 91/495                                           countries.                  with respect to high/low
 pigs, deer                                                                                 incidence regions.
                       92/118,80/215
 Fresh meat - 72/462, 94/438            9 CFR   95       Yesl                                                                            92/118          NE
 poultry
 Feathered             92/45            9 CFR 95         Yesl                                                                            92/45           NE
                       91/495                                                                                                            91/495
 farmed           and
 wild same
  Wild        Game, 92/45               9 CFR 95         Yes 2  Restrictions    for     BSE U.S. to review rules on BSE                  92/45           NE
                                                                countries.                  with respect to high/low
  Pics Deer                                                                                 incidence regions.
  Public health
  •Ml       •    IM     77/99,92/118    9 CFR 95         NE                                                                              77/99,92/118    NE                        EC to consider establishing!
 All species                                                                                                                                                                       conditions.                 \
                        64/433, 77/99, FIFRA,            NE                                                             FIFRA,           77/99,92/118    NE
 Feathered,             92/118          FFDCA,                                                                          FFDCA,           Draft Decision
 farmed           and                   21 CFR 70-82,                                                                   21 CFR 70-82,    notified     to
                                         108,       109,                                                                108,        109, WTO
 wild game                               110.3-110.93,                                                                  110.3-110.93,
                                         113, 170-189,                                                                  113, 170-189,
                                        510-529/556                                                                     510-529,556
                                                                                                                                                                                                           59
 ---pagebreak--- j - Commodity                          European Community Exports to the United States                                               United States Exports to the European Community
J- Species                      Trade Conditions         Equiv     Special Conditions                Actions                 Trade Conditions        Equiv   Special Conditions            Actions
          Animal/Public F.C Standards   U.S. Standards   (Cat)                                                        U.S. Standards  EC Standards   (Cat)
fhclth
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
                                         9 CFR 95      Yes 2   Not accepted   from    BSE U.S. to review rules on BSE                 72/462,97/221 NE                          EC to examine U.S. claim to
  Fresh         meat 64/432,72/461
                        80/215,72/462                          countries.                 with respect to high/low                                                              be BSE free.
  (•/uminants,                                                                            incidence regions.
  equidae, pigs)                                                                                                                                                                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..      |
   Farmed game -        91/495           9 CFR 95       Yes 2  Not accepted     from BSE U.S. to review rules on BSE                  91/495        NE
                                                               countries.                 with respect to high/low
   nigs, deer                                                                             incidence regions.
                         92/118,80/215   9 CFR 95       Yesl                                                                          92/118        NE
   Fresh meat -          72/462,94/438
   poultry
   Feathered            92/45            9 CFR 95       Yesl                                                                          92/45         NE
                         91/495                                                                                                       91/495
   farmed         and                                                                                                                                                                                       I
   wild name
                         92/45           9 CFR 95       Yes 2  Not accepted     from BSE U.S. to review rules on BSE                  92/45         NE
   Wild       Game,                                            countries.                 with respect to high/low
   Pigs Deer                                                                               incidence regions.
                                                                                                                                                                                                        60
 ---pagebreak---  1
J - CiMiunoditv                                 European Community Exports to the United States                                                United States Exports to the European Community
1
i
    - 'sj'OsU'S                          Trade Conditions          Equiv     Special Conditions                Actions                  Trade Conditions          Equiv       Special Conditions                  Actions
 j•             Animiil'Tulilii; I'C Standards   U.S. Standards    (Cat)                                                        U.S. Standards   EC Standards     (Cat)
  ihcilih
II
     26. Processed animal protein for human consumption cont'd                                                                                                                                                                     |
     Public health                                                                                                                                                                                                      .
     All species (A> 77/99,92/118                                 Yesl                                                                          77/99,92/118     NE
                                 77/99            FIFRA, PHSA, NE                                                               FIFRA, PHSA,    77/99,92/118     NE
     Feathered.                                   FFDCA,                                                                        FFDCA,          Draft Decision
     farmed              and                     21 CFR 70-82,                                                                  21 CFR 70-82,   notified      to
                         s
                                                  108,       109,                                                               108,       109, WTO
     wild•i i
              game (< )                           110.3-110.93,                                                                 110.3-110.93,                                                                  '
                                                  113, 170-189,                                                                 113, 170-189,
   I                                              510-529,556                                                                   510-529,556
     27. Processed animal protein not for human consumption
     Containing material of manumalian origin                                                                                                                                                                                      1
                                  92/118          9    CFR 95 Yes 2      Not accepted from      BSE U.S. to review rules on BSE FIFRA,          90/667,92/118    NE                                    EC to examine U.S. claim to |
     Ruminants                    90/667          FIFRA,                 countries.                 with respect to high/low FFDCA,             92/562,94/344                                          be BSE          free.       j
                                                  FFDCA,                                            incidence regions.          21 CFR 110.3- 96/449,97/198
                                                  21 CFR 110.3-                                                                 110.93,    507-                                                        EC to consider alternative
                                                  110.93,    507-                                                               509, 570, 573-                                                         guarantees for mammalian
                                                  509, 570, 573-                                                                589                                                                    material, including U.S.
                                                  589                                                                                                                                                  proposal to remove all risk
                                                                                                                                                                                                       material of known U.S. TSE
                                                                                                                                                                                                       species from petfood.
                                                  9     CFR 95 Yes 3                                                            FIFRA,          92/118, 90/667, NE      Establishments shall have
    1 Non-ruminants 92/118        90/667          FIFRA,                                                                        FFDCA,          96/449                  been validated by the U.S. for
                                                  FFDCA,                                                                        21 CFR 110.3-                           alternative heat treatment
                                                                                                                                                                                                                             i
                                                  21 CFR 110.3-                                                                 110.93,    507-                         including 30 day freedom
                                                   110.93,   507-                                                               509, 570, 573-                          from Clostridia
                                                   509, 570, 573-                                                               589
                                                   589
                                                                                                                                                                                                                               61
 ---pagebreak--- - Commodity                            European Community Exports to the United States                                            United States Exports to the European Community                    J
- Species                      Trade Conditions         Equiv    Special Conditions              Actions                   Trade Conditions         Equiv       Special Conditions       Actions     1
         Animal/Public EC Standards     U.S. Standards  (Cat)                                                      U.S. Standards   EC Standards    (Cat)
health
 27. Processed animal protein not for human consumption cont'd
 Containing only material of non mammalian origin
                                                       Yesl                                                                        90/667,92/118 NE
 Poultry         and 92/118,90/667 9 CFR 95                                                                                        92/562, 94/344,
                                                                                                                                                          Establishments shall have
                                                                                                                                                          been validated by the U.S. for
 fish                                                                                                                              97/198                 alternative heat treatment
                                                                                                                                                          including 30 day freedom
                                                                                                                                                          from Clostridia.
                       92/1 IS, 90/667  9 CFR 95       Yesl                                                                        92/118,90/667   NE
  Non-ruminants
 28. Scrum of eq uidae
                                                                                                                                   92/118,94/143   NE
 Animal health 92/118,94/143            9 CFR 95,122   NE
 29. Blood and blood products intended for human consumption                                                                                                                                        I
 Animal health
 Fresh          meat 64/432,    72/461 9 CFR 95,122 E
                       80/215,72/462
                                                              BSE rules for ruminants. U.S. to review rules on BSE 9 CFR 53
                                                                                       with respect to high/low
                                                                                                                                   72/462
                                                                                                                                   97/221
                                                                                                                                                   NE
 (ruminants,                                                                           incidence regions.
 equidac, pigs)                                                                        U.S. to produce generic
                                                                                       conditions for EC
                        91/495          9 CFR 95,122   Yes 2  BSE rules for ruminants. U.S. to review rules on BSE                 91/495          NE
  Farmed game -                                                                        with respect to high/low
 pigs, deer                                                                            incidence regions.
                        92/118,80/215   9 CFR 95, 122  Yesl                                                                        92/118          NE
  Fresh meat -          72/462, 94/438                                                                                                                                                           I
 poultry
                                                                                                                                                                                                   62
 ---pagebreak--- - Commodity                           European Community Exports to the United States                                            United States Exports to the European Community                                     |
- Species                      Trade Conditions        Equiv     Special Conditions              Actions                  Trade Conditions          Equiv       Special Conditions                  Actions         8
         Animal/l'ublic HC Standards   U.S. Standards  (Cat)                                                      U.S. Standards   EC Standards     (Cat)
health
 29. Blood and blood products intended for human consumption - Animal health - cont'd                                                                                                                               [
                                                                                                                                                                                                                     1
 Feathered              92/45,91/495   9 CFR 95, 122 Yesl                                                                         92/45            NE
                                                                                                                                  91/495
 fanned           and
 wild game
                                       9 CFR 95,122 Yesl                                                                          92/45            NE
 Wild        Game, 92/45
 Pius Deer
                                       9 CFR 301-381, NE                                                          9 CFR 301-381,  77/99,92/118     NE                                    EC to consider establishing!
 Public health 77/99                   416,        417                                                            416,        417 Draft Decision                                         conditions.                 j
                                        FFDCA,                                                                    FFDCA,          notified      to
                                        FIFRA, 21 CFR                                                             FIFRA, 21 CFR WTO
                                        110.3-110.93,                                                             110.3-110.93,
                                        507-509, 570,                                                             507-509, 570,
                                        573-589                                                                   573-589
 30. Blood and blood products not intended for human consumption
 Animal health 92/183,92/118 9122CFR 95.4, Yes 2 BSE             rules for ruminants.
                                                             Permit required
                                                                                      U.S. to review rules on BSE
                                                                                      with respect to high/low
                                                                                                                  9 CFR 53        92/183,92/118    Yes 2   Bluetongue
                                                                                                                                                          .requirements.
                                                                                                                                                                               treatment EC to consider use of tests
                                                                                                                                                                                         for Bluetongue in place ofj
                                                                                      incidence regions.                                                                                 treatment
                                                                                                                                                                                                                  63
 ---pagebreak---  - Commodity                           European Community Exports to the United States                                                United States Exports to the European Commumty          1
 - Species                      Trade Conditions            Equiv     Special Conditions              Actions                  Trade Conditions          Equiv Special Conditions  Actions     1
          Animal/Public EC Standards    U.S. Standards      (Cat)                                                      U.S. Standards   EC Standards     (Cat)
 health
1
  31. Lard and rendered fats intended for human consumption                                                         ^
  Animal health
  Fresh           meat 64/432           9 CFR 95           Yes 2  BSE rules for ruminants. U.S. to review rules on BSE                  72/462          NE
                         72/461                                                            with respect to high/low                     97/221
J (ruminants.
                         80/215                                                            incidence regions.
  horses, pigs)
  Fanned     game      - 91/495          9 CFR 95          Yes 2  BSE rules for ruminants. U.S. to review rules on BSE                  91/495          NE
                                                                                           with respect to high/low
  pigs, deer
                                                                                           incidence regions.
  Fresh      meat        92/118          9 CFR 95          Yesl                                                                         92/118          NE
                         80/215
  poultry                                                                                                            *
                         94/438
  Feathered farmed 92/45                 9 CFR 95          Yesl                                                                         92/45           NE
                         91/495                                                                                                         91/495
  and wild game
   Wild G a m e .   Pigs 92/45           9 CFR 95          Yes 2  BSE rules for ruminants: U.S. to review rules on BSE                  92/45           NE
                                                                                           with respect to high/low
i Deer
                                                                                           incidence regions.
   Public health
                          77/99,92/118                     NE                                                                           77/99,92/118    NE
   All species ^'
                          77/99           9 CFR 301-381, NE                                                            9 CFR 301-381,   77/99,92/118    NE
   Feathered,                             416,        417                                                              416,        417  Draft Decision
   farmed          and                    FIFRA, PHSA,                                                                 FIFRA, PHSA,     notified     to
      •i.       • (S)                     FFDCA,                                                                       FFDCA,           WTO
   wild game                              21 CFR 70-82,                                                                21 CFR 70-82,
                                           108,       109,                                                              108,       109,
                                           110.3-110.93,                                                                110.3-110.93,
                                           113, 170-189,                                                                113, 170-189,
                                         j 510-529, 556                                                                510-529,556                                                         •
                                                                                                                                                                                             64
 ---pagebreak---                                                                                                                                                     —  — • — — — — — —              '          ' — '          ' — '  —  »
- Commodity                            European Community Exports to the United States                                            United States Exports to the European Community
- Species                       Trade Conditions        Equiv     Special Conditions              Actions                  Trade Conditions          Equiv         Special Conditions                Actions
         Animal/Public EC Standards     U.S. Standards  (Cat)                                                      U.S. Standards   EC Standards      (Cat)
health
32. Lard and rendered fats not intended for human consumption
                       92/118           9 CFR 95       Yes 2  BSE rules for ruminants. U.S. to review rules on BSE                 92/118           NE                                EC to review requirements to
                       90/667                                                          with respect to high/low                    Draft Decision                                     consider         inclusion       of
                       72/461                                                          incidence regions.                          notified      to                                   alternative heat treatment
                                                                                                                                   WTO                                                systems.
                                                                                                                                                                                      EC       to       review      U.S.
                                                                                                                                                                                      bacteriological testing regime
                                                                                                                                                                                      for protein fraction
 33. Raw material for feeding stuffs, pharmaceutical or technical use
 Animal h e a l t h ! 9 2 " 1 8        ]9CFR95,i22 Yesl                                                            9 CFR 53        92/118                                             EC to consider laying downl
                                                                                                                                                                                      certification requirements for)
                                                                                                                                                                                      imports
 34. Apiculture products for apiculture
 Animal health | 9 2 / 1 1 8                                                                                                       92/118,94/860    NE
 35. Game trophies
 Animal health 92/118                    9 CFR 95      Yesl                                                        9 CFR 53        92/118
                                                                                                                                   96/590
                                                                                                                                                                                                                       65
 ---pagebreak---   Commodity
  Species
                                      European Community Exports to the United States
                               Trade Conditions          Equiv Special Conditions            Actions
                                                                                                                                   United States Exports to the European Commumty
                                                                                                                            Trade Conditions       Equiv   Special Conditions   Actions
                                                                                                                                                                                        i
         Animnl/Public EC Standards    U.S. Standards    (Cat)                                                     U.S. Standards    EC Standards  (Cat)
health
36. Manure
                                                                                  U.S. to provide temperature 9 CFR 53
Animal health P 1 1 8                  9 CFR 95
                                                                                  requirements for manure
                                                                                                                                     92/118
                                                                                  from regions affected        by
                                                                                  serious transmissible disease
37. Wool, feathers and hair
Animal health
                                                                                                                                                                                          !
                                                                                                             r
                       92/118          9 CFR 95         Yesl                                                       9 CFR 53          92/118       NE
AVool
                       92/118           9 CFR 95        Yesl                                                        9 CFR 53         92/118       NE
 -Pigbristlc                                                                                                                         94/435
 Public health                          FFDCA, PHSA NE                                                              FFDCA, PHSA                   NE
                                        21        CFR                                                               21         CFR
                                        1240.70                                                                     1240.70
 38. Honey                                                                                                       -.                                                                       |
 Animal health                                          NE                                                                                        NE
                                                                                                                                                                                          1
                        92/118          FFDCA,          NE                                                          FFDCA,           92/118       NE
 Public health                          FIFRA, PHSA                                                                 FIFRA, PHSA
                                        21 CFR 70-82,                                                               21 CFR 70-82,
                                        109,     110.3-                                                             109,      110.3-
                                        110.93,                                                                     110.93,
                                        520.182,                                                                    520.182,
                                        520.1660d                                                                   520.1660d
                                                                                                                                                                                        66
 ---pagebreak--- - Commodity                          European Community Exports to the United States                        United States Exports to the European Community
- Species                     Trade Conditions          Equiv Special Conditions  Actions           Trade Conditions        Equiv   Special Conditions             Actions •
         Animnl/Public EC Standards   U.S. Standards    (Cat)                               U.S. Standards   EC Standards   (Cat)
health
39. Frog's legs                                                                                                                                                                  |
 Animal health
                       92/118,96/340   FFDCA,          NE                                   FFDCA,           92/118,96/340 NE                            EC to review U.S. HACCP j
 Public health                         FIFRA, PHSA                                          FIFRA, PHSA                                                  rules when submitted.
                                       21 CFR 70-82,                                      - 21 CFR 70-82,
                                       108,     110.3-                                      108,     110.3-
                                       110.93,    113,                                      110.93,    113,
                                       114,123,1240                                         114,123,1240
 40. Snails for human consumption                                                                                                                                               |
 Animal health
                                                                                                                                                       •
 Public health         92/118,96/340   FFDCA,          NE                                   FFDCA,           92/118,96/340 NE
                                       FIFRA, PHSA                                          FIFRA, PHSA
                                       21 CFR 70-82,                                        21 CFR 70-82,
                                        108,    110.3-                                      108,      110.3-
                                        110.93,   113,                                      110.93,     113,
                                        114,123,1240                                        114,123,1240
                                                                                                                                                                               67
 ---pagebreak---     Commoditv                            European Community Exports to the United States                                                      United States Exports to the European Community
    S;vcies                       Trade Conditions          Equiv       Special Conditions                 Actions                     Trade Conditions         Equiv       Special Conditions                 Actions
l1 •        Animal/Public F.C Standards   U.S. Standards    (Cat)                                                              U.S. Standards   EC Standards    (Cat)
 S-U. Egg products for human consumption
 r-,—:       r            90/539          9 CFR 94         Yes 2  Permit required from areas U.S. to review permit                             90/539,93/342   Yesl
   /viumal health                                                 affected     by    Newcastle requirement.
                                                                  disease.
                          89/437, 91/684, 7 CFR 59                                             U.S. to supply information on 7 CFR 59          89/437, 91/684,        Establishments           listed EC to complete assessment of
    Public health         92/118. 96/23    EPIA     Public                                     the legal basis for recognition EPIA     Public 92/118, 96/23,         accordance with footnote U.S. public health legislation.
                                           Law 91-597                                          of equivalence.                 Law 91-597      97/38                  (7), and fulfilling         the
                                                                                                                                                                      relevant      provisions     of
                                                                                               U.S. to complete assessment                                            footnote (2).
                                                                                               of     EC     public     health
                                                                                               legislation                                                            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
                                                                                                                                                                                                                                68
 ---pagebreak--- i
  - Commodity                           European Community Exports to the United States                                                        United States Exports to the European Commumty                            1
  - Species                      Trade Conditions            Equiv       Special Conditions                 Actions                     Trade Conditions        Equiv  Special Conditions            Actions
           Animal/Public FC Standards    U.S. Standards      (Cat)                                                             U.S. Standards    EC Standards   (Cat)
  health
  42. Shell Eggs
   Animal health P 5 3 9                 9 CFR 94           Yes 2  Permit required from areas U.S. to review permit 9 CFR 94
                                                                   affected     by    Newcastle requirement.
                                                                                                                                                 90/539,93/342 Yesl
                                                                   disease.
                         89/437,91/684   FFDCA,                                                 U.S. to review legal basis for FFDCA,            89/437,91/684                            EC to complete assessment of j
   Public health         94/371,96/23     FIFRA, PHSA,                                          recognition of equivalence.    FIFRA, PHSA, 94/371,96/23                                  U.S. public health legislation
                                          EPIA                                                                                 EPIA
                                          21          CFR                                       U.S. to complete assessment 21             CFR
                                          5.10(a)(4) and                                        of     EC     public   health 5.10(a)(4) and
                                          (a) (13), 70-82,                                      legislation.                   (a) (13), 70-82,
                                          100.135, 110.3-                                                                      100.135, 110.3-
                                          110.93,                                                                              110.93,
                                          172.140,                                                                             172.140,
                                          172.882,                                                                             172.882,
                                          182.884, 178,                                                                        182.884, 178,
                                          520, 524, 556,                                                                       520, 524, 556,
                                          558,1240                                                                             558,1240
                                          40 CFR 180                                                                           40 CFR 180
                                          7 CFR 56                                                                             7 CFR 56
   43. Gelatin for human consumption and technical use                                                                                                                                                                    |
   Animal health                          9 CFR 94          NE                                                                                                 NE
                          92/118          FFDCA,            NE                                                                 FFDCA,            92/118        NE
   Public health                          FIFRA, PHSA                                                                          FIFRA, PHSA
                                                                                                                                                                                                                  '       I
                                          21 CFR 70-82,                                                                        21 CFR 70-82,
                                           109,      110.3-                                                                     109,      110.3-
                                           110.93,    570,                                                                      110.93,    570,
                                           573-589                                                                             573-589
                                                                                                                                                                                                                       69
 ---pagebreak--- 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
 ---pagebreak--- 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
 ---pagebreak---       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.
                                                                                                                                                                                          72
 ---pagebreak---       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
 ---pagebreak---           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.
                                                                                                                                                                                        74
 ---pagebreak---       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.                                                                                                                                        ,
                                                                                                                                                                                                75
 ---pagebreak---      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
 ---pagebreak--- 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 asfreshmeat.
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 separatefromthose 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
 ---pagebreak---                                                     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.      Thefrequencyof 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
 ---pagebreak---   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
 ---pagebreak---  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.
                                                                                                                   80
 ---pagebreak---  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.
 ---pagebreak---                                                    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 outfrontierchecks.
 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
importedfromthe exporting Party.
The Parties may modulate the;r physical checkingfrequenciesfor 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.
                                                                                                           82
 ---pagebreak---                                      ANNEX VIII
                              OUTSTANDING ISSUES
The Parties agree to work to further develop agreed arrangements concerning frontier checks,
including thefrequencyof physical checks.
The Parties agree to work together on their respective arrangements concerning feed additives,
animal feedingstuffs, medicated feeds and premixes.
                                                                                            83
 ---pagebreak---                                         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
 ---pagebreak---                                                                    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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