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
Date: 1997-11-12
Institutions: European Commission
Subjects: United States, animal product, health control, protection of animals, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels,  12.11.1997 
COM(97) 566 final 

97/0301 (ACC) 

Proposal  for a 

COUNCIL DECISION 

on the conclusion of the Agreement between the United States of America and the 
European Community on sanitary measures to protect public and animal health in trade 
in live animals and animal products 

(presented by the Commission) 

EXPLANATORY  MEMORANDUM 

Background 

Since the Commission  started making inspections of meat-exporting establishments  in 
the USA  in the mid  1980s, trade difficulties  have arisen because of the differences  in 
approach  to  health  measures  adopted  by the  EC  and  the  USA.  In  order  to  overcome 
these trade problems, an agreement  (the "red meat agreement")  was negotiated  in the 
early  1990s and adopted by the Council  in October  19921. This Agreement  recognized 
that  the  regulatory  systems  of  both  parties  basically  provide  equivalent  safeguards 
against  public  health  risks. It  set  out  the technical  solutions  needed  to  allow  trade  to 
continue  and  concluded  that  the  two  parties  would  initiate  discussions  as  soon  as 
possible  on  other  problems  in the  veterinary  field  in relation  to  trade  in  animals  and 
products of animal origin. 

Further  impetus  was  given  to  these  discussions  by  the  entry  into  force  on  1 January 
1995  of  the  WTO  Agreement  on  the  Application  of  Sanitary  and  Phytosanitary 
Measures  (the  SPS  Agreement),  which  provides,  in  Article  4,  that  Members  shall 
accept  the  sanitary  measures  of other  Members  as equivalent,  even  if those  measures 
differ  from  their  own,  if  the  exporting  Member  objectively  demonstrates  to  the 
importing  Member  that  its  measures  achieve  the  importing  Member's  appropriate 
level of sanitary protection. This Article also requires Members, upon request, to enter 
into  consultations  with  the  aim  of  achieving  bilateral  and  multilateral  agreements  on 
recognition of the equivalence of sanitary measures. 

On  20  February  1995, the  Council  agreed  a mandate  authorizing  the  Commission  to 
conduct  negotiations  with  a  view  to  the  conclusion  of  agreements  between  the 
Community  and  third  countries  on  sanitary  and phytosanitary  measures,  on the  basis 
of negotiating directives annexed to its decision. 

Following  this  mandate,  the  Commission  has, with  the  participation  of  experts  from 
the  Member  States,  conducted  negotiations  with  a  number  of  third  countries. 
Agreements  have  been  concluded  with  New  Zealand  and  the  Czech  Republic,  and 
negotiations are continuing with Australia, Canada, Uruguay, Chile and Argentina. 

This proposal presents the results of negotiations  with the USA, which  are now ready 
to be proposed to the Council. 

The legal base for the agreement is Article  113 and the first  sentence of Article 228(2) 
of the Treaty, as in the case of the most recent agreement with the Czech Republic. 

Council Decision  93/158/EEC, OJ N° L 68,  19.3.1993, p. 1 

7^ 

Scope and purpose of the draft  Agreement 

The  draft  Agreement  covers  sanitary  measures  affecting  trade  in  the  animals  and 
animal  products  listed  in  Annex  I  of  the  text.  However,  due  to  the  very  significant 
differences  in approach to certain measures, the draft  Agreement excludes the matters 
referred  to Article  3(2), including  measures related  to drug residues  (e.g.  hormones). 
These remain subject to the legislation of each party in respect of trade. 

The purpose  of  the  draft  Agreement  is to  facilitate  trade  between  the  parties  in  live 
animals  and  animal  products  by  establishing  a  mechanism  for  the  recognition  of 
equivalence of sanitary measures where this is possible, and establishing a  framework 
for working towards equivalence in other areas. 

For each party, equivalence can only be accepted  in cases where the party  is  satisfied 
that the  agreed  conditions  of trade meet its chosen  level  of  sanitary  protection.  In  all 
cases,  it  is  the  right  of  the  importing  party  to  determine  if  the  measures  of  the 
exporting  party  meet  its  level  of  protection.  The  rights  of  parties  under  the  WTO 
Agreements  are  not  affected  by  the  provisions  of  the  draft  Agreement,  but  the 
intention  of  the  draft  Agreement  is  to  work  towards  mutually  acceptable  solutions 
instead of allowing damaging trade disputes to develop. 

Provisions  are  included  for  the  exchange  of  information  on  matters  relating  to  the 
draft  Agreement,  including  specific  provisions  for  the  notification  to  each  other  of 
outbreaks  of  disease.  A  safeguard  clause  is  also  included,  allowing  parties  to  take 
unilateral emergency measures to protect human or animal health. 

The  agreement  makes  reference  to  those  responsibilities  which  fall  to  the  Member 
States and those which are Community responsibilities (see Annex II.B). 

In effect,  the  Community  is responsible  for  sanitary  measures  relating  to  the  placing 
on  the  Community  market  of  live  animals  and  animal  products,  whether  produced 
domestically  or  imported,  while  the  Member  States  are  responsible  for  ensuring 
compliance of exports with USA requirements. 

Joint Management  Committee 

The draft  Agreement  establishes a Joint Management  Committee with  responsibilities 
for  guiding the activities provided for in the text and for carrying out a regular review, 
at least once per year, of progress made in the recognition of equivalence. 

As the draft  Agreement represents a starting point, and contains a very  comprehensive 
work  programme  in  Annex  V,  this  Committee  will  play  an  important  role  in 
coordinating progress with the implementation of the programme. 

In  addition,  the  Joint  Committee  may  recommend  changes  to  the  Annexes  as  and 
when these become necessary as a result of progress in the continuing  negotiations. 

1b 

Implementation of changes to the Agreement 

Each  party  will  have  to  implement  any  agreed  changes  in  accordance  with  its 
legislative procedures procedures (Article  16.2 of the Framework text). In the case of 
the  Community,  it  is  proposed  to  do  this  by  Commission  Decision,  following  an 
opinion of the Standing Veterinary Committee (3b "contrefilet" procedure). 

It  should  be  stressed  that  nothing  in  this  draft  Agreement  changes  Community 
legislation;  any  such change which  could  be necessary  in the  future  would  have to 
been made by the Council and Parliament on the basis of Article  100A, if there are 
implications for public health, or any other appropriate legal basis. 

-7  c 

*^*';fJUv#ri 

PROPOSAL FOR A COUNCIL DECISION  ^ 

on the conclusion of the Agreement between the United States of America and the ' 
European Community on sanitary measures to protect public and animal health in trade 
in live animals and animal products 

THE COUNCIL OF THE EUROPEAN UNION,  . ; 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 113 and Article 228, paragraph 2, first sentence, thereof, 

Having regard to the proposal from the Commission, 

Wheieas  the  Agreement  between  the  United  States  of  America  and  the  European 
Community  on  sanitary  measures  to protect  public  and  animal  health  in  trade  in  live 
animals  and  animal  products  provides  an  adequate  means  for  putting  into  practice  the 
provisions  of  the  WTO  Agreement  on  the  Application  of  Sanitary  and  Phytosanitary 
Measures as regards public and animal health measures; 

Whereas  the  Agreement  will  contribute  towards  facilitating  bilateral  trade  between  the 
United  States • of  America  and  the  European  Community  in  live  animals  and  animal 
products through the progressive recognition of the equivalence of sanitary measures, the 
recognition  of  animal  health  status,  the  application  of  régionalisation  and 
the 
improvement of communication  and cooperation; 

Whereas  it. is  appropriate  to  make  provisions  for  a  procedure  establishing  close  and 
effective  cooperation  between  the  Commission  and  the  Member  States  within  the 
Standing Veterinary Committee; 

Whereas the Agreement should be approved on behalf of the Community, 

HAS DECIDED AS FOLLOWS: 

Article 1 

The Agreement  between  the  United  States of America and the European  Community  on 
sanitary measures  to protect public and animal health in trade in liye animals and animal 
products is hereby approved on behalf of the Community. 

The text of the Agreement and the Annexes thereto are attached to this Decision. 

Article 2 

The President  of the  Council  is hereby autliorised to designate the person  empowered  to 
sign the Agreement in order to bind the Community. 

1  d-

Article 3 

i'y'vâîî-:'' 

3|0t|||;^Trî^ measures' necessary for the implementation of this Agreement, including as regards 
"l^^^â^ineaf-randtmeat,  based  products  guarantees  equivalent  to  those  laid  down  by 
^^^V6ïrectivâ7^462/EEC(I>,  shall  be  established  pursuant  to  the  procedure  laid  down  in 
s 

« .^j«ç^?Ârticle 30' of that Directive..-, 

~ 

^-^^^PHfeSK-îC*-: «  * ' 

•  ••:$& • - '-  • ::^A  Article 4 

/.'•-  - > ;^TheXommission, assisted by representatives of Member States' veterinary services, shall 
/s  - 
-^represent: ^.Community  in. the'Joint Management Committee referred to in Article  14 

Z (1) of the Agreement 

The Commission is authorized to approve modifications to the annexes to the Agreement 
of  behalf  of  the  Community,  in  accordance  with  the  recommendations  of  the  Joint 
Management Committee, pursuant to the procedure laid down in Article 29 of Directive 
72/462/EEC. 

Articles 

This Decision shall be published in the Official Journal of the European Communities. 

This Decision shall take effect on the date of its publication. 

Done at Brussels, 

For the Council 

The President 

(1) 

OJ.  N°  L  302,  31.12.1972,  p.  28.  Directive  ZLS last  amended  by  Directive  Nc 
96/91/EC(OJ.N°L  13, 16.01.1996, p. 26). 

7<* 

DRAFT AGREEMENT 

between the United States of America and the European Community on 

sanitary measures to protect public and animal health 

in trade in live animals and animal products 

/ 

DRAFT AGREEMENT 

between  the  United  States of America  and  the  European  Community  on sanitary  measures  to  protect  public 

and animal health in trade in live animals and animal products 

THE GOVERNMENT OF THE UNITED STATES OF AMERICA 

ofthetme part, and 

THE EUROPEAN COMMUNITY 

of the other part, 

DESIRING  to  safeguard  public  and  animal  health  and  to  facilitate  trade  in  animals  and  animal  products 

between  the  United  States  of  America  (hereinafter  referred  to  as  'the  U.S.')  and  the  European  Community 

(hereinafter referred to as 'the Community'); 

RESOLVED to take the fullest  account of the risk of spread of animal diseases and the measures put in place 

to control and eradicate such diseases, and in particular to avoid disruptions to trade; 

REAFFIRMING  their  commitment  to  the  rights  and  obligations  established  under  the  World  Trade 

Organisation  Agreement  on the Application  of Sanitary and Phytosanitary  Measures (hereinafter  referred  to 

as the 'SPS Agreement'); 

WHEREAS the Parties acknowledge  that their  systems  of sanitary measures  are  intended  to  address  similar 

objectives of providing comparable health assurances; 

NOTING  that  the  recognition  by  an  importing  country  of  the  sanitary  measures  applied  by  an  exporting 

country can permit greater efficiency  in the utilization of inspection and verification resources; 

HAVE  DECIDED  to  conclude  this  Agreement  and  to  this  end  have  designated  respectively  as  their 

plenipotentiaries: 

THE GOVERNMENT OF THE UNITED STATES OF AMERICA 

THE EUROPEAN  COMMUNITY 

WHO HAVE AGREED AS FOLLOWS: 

Article 1 

Objective 

The objective of this agreement is to facilitate trade in live animals and animal products between the U.S. and 

the  Community  by  establishing  a  mechanism  for  the  recognition  of  equivalence  of  sanitary  measures 

maintained  by  a  Party  consistent  with  the  protection  of  public  and  animal  health,  and  to  improve 

communication and cooperation on sanitary measures. 

Article 2 

Multilateral  Obligations 

Nothing in this Agreement shall limit the rights or obligations of the Parties under the Agreement  establishing 

the World Trade Organisation and its Annexes, in particular the Agreement on the Application of Sanitary and 

Phytosanitary Measures. 

Article 3 

Scope 

1. 

This Agreement shall initially be limited to the sanitary measures applied by either Party to  the live 

animals and animal products listed in Annex I, except as provided for in paragraph 2. 

2. 

Unless  otherwise  specified  under  the  provisions  set  out  in  the  Annexes  to  this  Agreement,  this 

Agreement  shall not apply to sanitary measures related to food  additives, processing  aids,  flavours, 

colour  additives,  sanitary  stamps, 

irradiation  (ionisation),  contaminants  (including  pesticides, 

chemical  residues,  mycotoxins,  natural  toxins,  physical  contaminants  and  animal  drug  residues), 

chemicals  originating  from  the  migration  of  substances  from  packaging  materials;  labelling  of 

foodstuffs  (including nutritional labelling); feed additives, animal feedingstuffs,  medicated feeds  and 

premixes. 

3. 

The Parties may agree to modify  this Agreement in the future  to extend the scope to other sanitary or 

phytosanitary  measures affecting  trade between the Parties. 

Article 4 

Regulatory  Authorities 

1. 

The  U.S. -  regulatory  authority  for  imports  and  exports  of  live  animals  and  animal  products  is  as 

described in part A of Annex II. 

2. 

The Community - control in veterinary affairs  is as described  in part B of Annex II. 

Article 5 

Definitions 

For the purposes of this Agreement the following  definitions  shall apply: 

(a) 

sanitary  measures  means  sanitary  measures  as  defined  in  Annex  A,  paragraph  1,  of  the  SPS 

Agreement  and  falling  within the scope of this Agreement. The reference  to sanitary measures  may 

cover individual sanitary measures or groups of sanitary measures for  product areas, sectors, or parts 

of sectors, as appropriate; 

(b) 

appropriate  level of  sanitary protection means the appropriate level of sanitary  protection  as  defined 

in Annex A, paragraph 5, of the SPS Agreement; 

(c) 

region  means  "zones"  or  "regions"  as  defined  in  the  Animal  Health  Code  of  the  Office 

International  des  Epizooties  (OIE),  and  for  aquaculture  as  defined  in  the  International  Aquatic 

Animal Health Code of the OIE; 

(d) 

Agreement means the entire text of this Agreement and all its annexes. 

Article 6 

Animal  Health  Status 

The  importing  Party  shall  recognise  for  trade  the  health  status  of  regions,  as  determined  by  the 

exporting Party, with respect to the animal and aquaculture diseases specified  in Annex III. 

2. 

The  importing  Party  shall  recognise  régionalisation  decisions  taken  by  the  exporting  Party  in 

accordance with the criteria set out in Annex  IV as the basis for trade from a  Party where art area  is 

affected  by one or more of the diseases listed in Annex III. 

3. 

Where a Party considers that it has a special status with respect to a specific  disease other than  those 

in  Annex  III,  it  may  request  recognition  of  this  status.  The  importing  Party  may  also  request 

additional  guarantees  in  respect  of  imports  of  live  animals  and  animal  products  appropriate  to  the 

agreed status.  The guarantees for specific diseases are specified  in Annex V. 

The exporting Party shall, if requested by the importing Party, provide full explanation and supporting data  for 

the determinations  and  decisions  covered  by this Article. The  importing  Party  may, where  necessary  for  the 

protection of animal health, invoke the provisions of Article 12. 

Article 7 

Equivalence 

In reaching  a determination  whether  a sanitary  measure  maintained  by  an  exporting  Party  achieves 

the  importing  Party's appropriate  level  of sanitary  protection, the Parties shall  follow  a  consultative 

process that includes the following steps: 

i) 

identification  of the sanitary measure for which recognition of equivalence is sought; 

ii) 

explanation  by  the  importing  Party  of  the  objective  of  its  sanitary  measure,  including  an 

assessment,  as  appropriate  to  the  circumstances,  of  the  risk  or  risks,  that  the  sanitary 

measure  is intended to address, and identification  by the importing  Party  of  its  appropriate 

level of sanitary protection; 

iii) 

demonstration  by  the  exporting  Party  that  its  sanitary  measure  achieves  the  importing 

Party's appropriate level of sanitary protection ; 

iv) 

determination  by  the  importing  Party  whether  a  sanitary  measure  achieves  its  appropriate 

level  of  sanitary  protection  after  consideration  of  various  factors,  including  where 

appropriate: 

(a) 

risks  identified  by  the  importing  Party  and  evidence  provided  by  the  exporting 

Party that its sanitary measures effectively  address those risks; 

(b) 

provisions of the exporting Party's legislation and regulations regarding standards, 

procedures, policies, infrastructure, enforcement and control; 

(c) 

powers of the exporting Party's regulatory authorities and their structure, including 

their chain of command, modus operandi, and resources; 

(d) 

evidence provided  by the exporting  Party of the efficacy  of  its  enforcement  and 

control programs. 

The  importing  Party  may  carry  out  verification,  as  set  out  in  Article  9,  to  assist  this 

determination. 

2. 

In  carrying  out  the  consultative  process  described  in  paragraph  1, and  setting  the  trade  conditions 

referred  to  in  Article  8.2  (b),  the  Parties  shall  take  account  of  experience  and  information  already 

acquired. 

3. 

Work under, or conclusion of,  the consultative process for one product area, sector, or part of sector, 

shall not be dependent upon or delayed by work on any other product area, sector, or part of sector. 

4. 

The final determination  whether  a sanitary  measure  maintained  by  an  exporting  Party  achieves  the 

importing Party's appropriate  level of sanitary protection rests solely with the importing  Party  acting 

in  accordance with its administrative and legislative  framework. 

Article 8 

Status of Consultations 

Annex  V  lists  the  live  animals  and  animal product  areas, sectors, or parts  of  sectors,  and,  for  each 

area,  sector  or  part  thereof,  sets  forth  the  status  of  consultations  regarding  the  recognition  of 

equivalency of a Party's sanitary measures and the applicable trade conditions. 

a) 

With respect to sanitary measures recognised as equivalent for trade purposes  at the date of 

entry  into  force  of this  Agreement,  each  Party,  within  its responsibilities,  shall  initiate  the 

necessary  legislative  and  administrative  actions  within  3  months  to  implement  these 

recognitions. For sanitary measures that will be recognised  as equivalent  in the future,  each 

Party shall take prompt and necessary steps to implement the recognitions. 

b) 

Where the trade conditions specified  in Annex V include special conditions required  by the 

importing  Party to meet  its appropriate  level of protection, trade shall take place where  the 

exporting Party meets the importing Party's conditions, without prejudice  to the continuing 

consultative process. 

3. 

The Parties shall  carry out the respective  actions set out  in Annex  V, taking  into account  the  target 

deadlines  for  each  product  area,  sector,  or  part  of  sector,  with  a  view,  where  possible,  to  reaching 

recognition of equivalence, and to facilitate trade. 

4. 

Annex  V  may  be  modified  in  accordance  with  Articles  14.2 and  16.2  to  reflect  changes  made  by 

each Party in recognitions or trade conditions. 

Article  9 

Verification  Provisions 

1. 

The determination of the nature and frequency of checks to be applied to imports of live animals and 

animal  products  at  external  frontiers  rests  solely  with  the  importing  Party.  Annex  VII  contains 

principles which shall guide such frontier checks. 

2. 

In addition to carrying out checks on imports at the external frontier, the importing Party may  verify 

compliance with the provisions of this Agreement through the application  of procedures  which  may 

include, but are not limited to: 

(a) 

an  assessment  of  all  or  part  of  the  exporting  Party's  total  control  programme,  including, 

where appropriate, reviews of the exporting Party's inspection and audit programmes; and 

(b) 

on-site checks and inspections. 

3. 

The  Community  will  carry  out  the  verification  procedures  provided  for  in  paragraph  2.  The  U.S. 

agencies  identified  in  Annex  II  shall  facilitate  the  performance  of these  verification  procedures  by 

the Community. 

4. 

The  U.S. agencies  identified  in Annex  II will  carry  out  the verification  procedures  provided  for  in 

paragraph  2.  The  Community  shall  facilitate  the  performance  of  these  verification  procedures  by 

those agencies. 

Upon the mutual consent of the Parties to this Agreement, either Party may: 

(a) 

share  the  results and  conclusions  of  its verification  procedures  with  countries that  are  not 

parties to this Agreement, or 

(b) 

use the results and conclusions  of verification  procedures carried out by countries  that  are 

not parties to this Agreement. 

Each Party shall carry out the verification  procedures in accordance with Annex VI. The Parties  may 

agree  to  modify  Annex  VI,  taking  due  account  of  relevant  work  carried  out  by  International 

Organisations. 

Article 10 

Information  Exchange 

1. 

The 

Parties  shall  exchange  information  on  a  uniform  and  systematic  basis  to 

improve 

communication,  to  engender  mutual  confidence,  and  to  demonstrate  the  efficacy  of  the  programs 

controlled.  Where appropriate, this may be supported by exchanges of officials  between the Parties. 

2. 

The  Parties  shall  notify  each  other  of  proposals  to  introduce  new  sanitary  measures  or  to  change 

existing sanitary measures, and shall provide the opportunity to comment on such proposals. 

3. 

In  addition  to  information  on  changes  in 

sanitary  measures,  the  Parties  shall  also  exchange 

information  on other relevant topics including: 

current developments affecting  trade in live animals and animal products, 

the results of the checks and verification procedures provided for in Article 9. 

4. 

Where a Party establishes, maintains or recognises a scientific committee, commission, expert  group 

or other similar entity competent to study an issue relevant to this Agreement, the Party shall  ensure 

timely consideration  of,  and response to, relevant scientific  papers or studies submitted by the  otlier 

Party. 

5. 

The  Parties  agree  to  establish  an  appropriate  means  of  exchanging  information  on  rejected  import 

consignments,  relevant  inspection-related  information,  and other problem  areas concerning  public  or 

animal  health. 

6. 

The contact  points  for this information  exchange arc set out in Annex IX. 

Article 11 

Notification 

1. 

Each Party shall notify the other: 

(a) 

immediately by oral communication  followed  within 24 hours in writing: of any serious  or 

significant  public or animal health risk, notably  including any food  control  emergencies  or 

situations where there is a clearly identified risk of serious health effects  associated with the 

consumption of animal products; 

(b)  within 24 hours in writing: of the presence or evolution  of any disease  listed  in Annex  III; 

and 

(c)  without  delay  and  in  writing:  of  any  significant  changes  in  animal  health  status  or  of 

findings of  epidemiological  importance with  respect  to diseases  other  than  those  listed  in 

Annex III; of changes in preventive policies, including vaccination policies; or, of any non-

routine measures taken to protect public health or to control or eradicate animal disease. 

2. 

3. 

Such notifications  shall be made to the contact points set out in Annex IX. 

Where  either  Party  has  serious  concerns  regarding  a  risk  to public  or  animal  health,  consultations 

regarding  the  situation  shall, on  request,  take place  as soon  as possible,  and  in  any  case  within  14 

days.  Each Party shall endeavour in such situations to provide all the information  necessary to avoid 

a  disruption  in trade, and to  reach  a  mutually  acceptable  solution  consistent  with  the  protection  of 

public or animal health. 

Article 12 

Safeguards 

Either  Party  may  take  provisional  measures  necessary  for  the protection  of public  or  animal  health.  These 

measures  shall  be  notified  within  24  hours  to  the  other  Party,  and,  on  request,  consultations  regarding  the 

situation shall be held within  14 days. The Parties shall take due account of any information  provided  through 

such  consultations,  and  shall  endeavour  to  avoid  unnecessary  disruption  to  trade,  taking  advantage  where 

possible of the provisions of Article  11.3. 

Article 13 

Outstanding  Issues 

The  principles  of  this  Agreement  shall  also  be  applied  to  address  outstanding  issues  listed  in  Annex  VIII. 

Modifications  shall  be  made  to this  Annex  and,  as  appropriate,  other  Annexes, to  take  account  of  progress 

made and new issues  identified. 

Article 14 

Joint Management  Committee 

1. 

A  Joint  Management  Committee  (hereinafter  referred  to  as  'the  Committee'),  consisting  of 

representatives  of the U.S. and  the Community,  is hereby  established  to  guide the activities  carried 

out under this Agreement.  The Committee shall meet within one year of the entry into force  of this 

Agreement  and  at  least annually  thereafter.  The Committee  may also address  issues out of  session 

by correspondence. 

2. 

The  Committee  shall, at  least once  a year,  review  the  Annexes  to  this Agreement  As  appropriate, 

this  review  will  take account  of  progress  made on  the continuing  consultative  process  towards  the 

recognition  by  the  importing  Party  of  the  equivalence  of  sanitary  measures  maintained  by  the 

exporting  Party  and  progress  in  completing  the  actions  set  out  in  Annex  V.  The  Committee  may 

recommend changes to the Annexes. 

3. 

The Parties agree to establish Technical  Working Groups, consisting  of expert-level  representatives 

of  the  U.S.  and  the  Community,  which  shall  identify  and  address  technical  and  scientific  issues 

arising from this Agreement. 

When  additional  expertise  is  needed,  the  Parties  may  also  establish  ad  hoc  Technical  Working 

Groups, notably scientific  groups, whose membership need not be restricted to representatives  of the 

Parties. 

10 

Article 15 

Territorial  Application 

This Agreement shall apply, on the one hand, to the United States in respect of its entire territory, and, on the 

other hand, to the territories  in which  the Treaty  establishing  the European  Community  is applied  and  under 

the conditions laid down in that Treaty. 

Article 16 

Final  Provisions 

1. 

This Agreement shall be approved by the Parties in accordance with their respective procedures.  > 

This Agreement shall enter  into force on the first day of the month  following  the date on which the 

Parties  notify  each  other  that  the  procedures  mentioned  in the  preceding  sub-paragraph  have  been 

completed. 

2. 

Each  Party  shall  implement  the  commitments  and  obligations  arising  from  this  Agreement  in 

accordance  with  its  laws  and  procedures.  Any  changes  to  the  annexes  to  this  Agreement  that  are 

agreed by the Parties shall be implemented accordingly. 

3. 

Either  Party  may  at  any  time  propose  modifications  to  this  Agreement.  Either  Party  may,  upon  6 

months' notice withdraw from the Agreement. 

4. 

This Agreement shall be drawn  up  in two copies  in the English  language, each  of these texts  being 

equally authentic. 

For  the  Government  of the 

For  the  European  Community 

United  States  of A  merica 

11 

LIST OF ANNEXES 

ANNEX I 

PRODUCT COVERAGE 

ANNEX II 

REGULATORY  AUTHORITIES 

ANNEX III 

LIST OF DISEASES FOR WHICH REGIONAL FREEDOM IS RECOGNISED 

ANNEX IV 

ZONING AND RÉGIONALISATION 

ANNEX V 

RECOGNITION OF SANITARY MEASURES 

ANNEX VI 

GUIDELINES FOR CONDUCTING AN AUDIT 

ANNEX  VII 

FRONTIER  CHECKS 

ANNEX VIII 

OUTSTANDING ISSUES 

ANNEX IX 

CONTACT POINTS 

12 

ANNEX I 

PRODUCT COVERAGE 

Tariff  Line 

General Description* 

01 

02 

03 

04 

05 

15 01 

15 02 

15 03 

15 04 

15 05 

15 06 

Live animals 

Meat and edible meat  offal 

Fish and crustaceans, molluscs and other aquatic invertebrates 

Dairy  produce;  birds'  eggs;  natural  honey;  edible  products  of  animal  origin  not 
elsewhere specified  or included 

Products of animal origin, not elsewhere specified  or included, except for  products 
of human origin 

Lard; other pig and poultry fat, rendered, 

Fats of bovine animals, sheep or goats, 

Lard stearin, lard oil, oleostearin, oleo-oil1 and tallow oil, 

Fats and oils and their fractions, of fish and marine mammals, 

Wool grease and fatty substances derived therefrom  (including  lanolin) 

Other animal fats and oils and their fractions, 

15 16 10 

Animal fats and oils and their fractions, 

15 17 

15 18 

15 22 

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 

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 

Degras;  residues  resulting  from  the  treatment  of  fatty  substances  or  animal  or 
vegetable  waxes,  except  for  such  products  consisting  solely  of  material  of  non-
animal origin 

For definitive  description, refer  to Tariff  Code 

16 

Preparations  of  meat,  of  fish  or  of  crustaceans,  molluscs  or  other  aquatic 
invertebrates 

17 02  10 

Lactose and lactose syrup 

19 01 

19 02 

21 04 

21 05 

21 06 

23 01 

23 09 

30 01 

30 02 

3101 

35 01 

35 02 

35 03 

35 04 

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 

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 

Soups  and  broths  and  preparations  therefor;  homogenized  composite  food 
preparations;  except  such  products  consisting  solely  of  products  of  non-animal 
origin 

Ice  cream  and  other  edible  ice,  whether  or  not  containing  cocoa;  except  such 
products consisting solely of products of non-animal origin 

Food  preparations  not  elsewhere  specified  or  included;  except  such  products 
consisting solely of products of non-animal origin 

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 

Preparations  of  a  kind  used  in  animal  feeding;  except  such  products  consisting 
solely of products of non-animal origin 

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; 

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 

Animal or vegetable fertilisers, except such products consisting  solely of  products 
of non-animal  origin 

Casein, caseinates and other casein derivatives; casein glues 

Albumins, albuminates and other albumin derivatives 

Gelatin  and  gelatin  derivatives;  isinglass; other  glues  of  animal  origin,  excluding 
casein glues of heading No 3501 

Peptones  and  their  derivatives; other  protein  substances  and  their  derivatives,  not 
elsewhere specified  or included; hide powder, whether or not chromed 

35 07 

Enzymes; except such products consisting solely of products of non-animal  origin 

14 

4101 

41 02 

41 03 

Raw hides and skins of bovine or equine animals 

Raw skins of sheep or lambs 

Other raw hides or skins 

43 01 

Raw  furskins 

51 01 

51 02 

51 03 

51 05 

Wool 

Fine or coarse animal hair 

Waste of wool or of fine or coarse animal hair 

Wool and fine or coarse animal hair 

97 05 

Collections and collectors' pieces of zoological interest 

15 

\ M « f t<  • "• 

ANNEX II 

A. 

I. 

U.S. REGULATORY  AUTHORITY 

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) 

b) 

c) 

d) 

Live  animals  (including  apiculture  bees),  embryos,  ova,  semen  and 
animal  products  -  U.S.  Department  of  Agriculture/Animal  and  Plant 
Health Inspection Service (USDA/APHIS) 

Imports  of  salmonid  live fish, gametes and  fertilized  ova  —  Department 
of Interior/Fish and Wildlife Service (DOI/FWS) 

Imports of uneviscerated salmonid fish - DOI/FWS 

Animal Feed (including Pet Foods) 

1) 

2) 

Transmission  of disease from  feed  - USDA/APHIS 

Adulteration,  pesticides, chemical  and  microbial  contamination, 
food  additives, substances "generally  recognised  as safe" - Food 
and  Drug Administration  (FDA) 

16 

B. 

CONTROL OF PUBLIC HEALTH 

1. 

Meat and poultry for human consumption 

a) 

Fresh  meat  and  products  from  domesticated,  farmed  and  wild  cattle, 
sheep, swine,  goats  and  equine  -  U.S.  Department  of  Agriculture/Food 
Safety and Inspection Service (USDA/FSIS)2 

b) 

Fresh  meat  and  products  from  domestic  and  farmed  chickens,  turkeys, 

ducks, geese, and guinea fowl - USDA/FSIS-^ 

c) 

d) 

e) 

Fresh meat and products from wild and farmed  game, with the exception 
of those from IB 1(a) and IB 1(b) above - (FDÀ) 

Fresh meat and products from species other than above - FDA 

Enforcing  adulteration  provisions  of  the  law  and  limits  for  residues  of 
drugs,  pesticides, heavy  metals,  mycotoxins,  and  other  contaminants  in 
food 

1. 

2. 

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 

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) 

b) 

Shell  eggs,  hard-cooked  eggs,  ethnic  egg  delicacies,  and  imitation  egg 
products - FDA 

Shell eggs (including  cracks and dirties)  for  breaking  for  the  production 
of  liquid,  frozen,  and  dried  egg  products  (egg  yolks,  albumen,  or  any 
combination) - USDA/FSIS4 

3. 

Dairy 

a) 

All dairy products - FDA 

With  very  limited  exceptions,  USDA/FSIS  has  sole jurisdiction  for  these  foods  until  the  time  they 
leave the slaughterhouse. After  the meat and products have left the slaughterhouse,  USDA/FSIS  and 
FDA share jurisdiction. 

FDA is responsible  for the approval of veterinary drugs and food  additives  in meat and  poultry 

See preceding  footnote 

FDA and  FSIS share jurisdiction  over these products after  they have left the processing  plant 

17 

4. 

Other Animal-Derived  Foods (including Fish and Fishery Products^ 

a) 

All other animal-derived  foods - FDA 

5. 

Animal Feed 

a) 

Adulteration,  pesticides,  chemical  and  microbial  contamination,  food 
additives, substances "generally recognised as safe" - FDA 

II. 

Competent Authorities for Voluntary Programs 

The  federal  agencies  listed  in this  section  are responsible  for  voluntary  inspection  and  certification 
programs for domestically-produced  animal product?. 

In relation to exports from the U.S., these agencies are responsible for: 

oversight  of  the  circumstances  of  domestic  production  and  processing  for  firms  who 
participate in the voluntary program. 

providing  information  concerning  compliance  with  agreed  upon  requirements  for  firms 
who participate in the voluntary program. 

providing agreed additional guarantees for firms who participate in the agreed program. 

A. 

ANIMAL HEALTH 

1. 

2. 

3. 

Non-salmonid  fish  and  other  non-mammalian  aquatic  animals,  gametes  and 
fertilised  ova  -  USDA/APHIS,  Department  of  Commerce/National  Marine 
Fisheries Service (Commerce/NMFS) 

Salmonid live fish, gametes, and fertilised  ova - USDA/APHIS,  Commerce/NMFS 

Animal  feed  (including  pet  foods)  containing  fish  and  fishery  products  -
USDA/APHIS, Commerce/NMFS 

B. 

PUBLIC HEALTH 

1. 

2. 

3. 

4. 

5. 

6. 

Fresh  meat  and  meat  products^  from  wild  and  farmed  bison,  ostrich,  emu,  rhea, 
rabbit, deer, partridge, and quail - USDA/FSIS 

Snakes for human consumption - Commerce/NMFS -

Shell eggs - USDA/AMS 

Cooked  omelets  made  from  egg  products,  diced  eggs  made  from  egg  products  -
USDA/FSIS 

Dairy - USDA/AMS 

Seafood  (including  live seafood)  - Commerce/NMFS 

These  meat  products  must  be  made  from  fresh  meat  slaughtered  under  the  USDA/FSIS  voluntary 
program. 

18 

III. 

Federal Agencies that Issue Certification 

This section lists the U.S. national agencies that issue export certificates agreed to by the EC and the US*>.  The 
agency  issuing certificates  may be the control  authority or another national agency that is recognised  by the 
control authority for that purpose. More than one agency may issue certificates for a product. 

DOC/ 
NMFS 

DOI/ 
FWS 

USDA/  USDA/  USDA/ 
FSIS 
APHIS 
AMS 

FDA 

A.  ANIMAL  HEALTH 
CERTIFICATIONS 

1.  Live  animals 
(including  apiculture  bees), 
embryos, ova, semen, and products of animal origin 

2.  Non-salmonid  fish  and  other  non-mammalian 
aquatic animals, gametes and fertilised  ova 

!X 

3. Salmonid live fish, gametes, and fertilised ova 

X 

4. Wild  waterfowl 

5. Animal  feed 

X 

X 

X 

X 

X 

X 

X 

B.  PUBLIC  HEALTH 
CERTIFICATIONS 
1. Meat and poultrv for human 
consumption 

a)  Fresh  meat  and  products  from 
domesticated,  farmed  and  wild  cattle, 
sheep,  swine,  goats,  and  equine,  and 
domesticated  and  farmed  chickens, 
turkeys,  ducks,  geese,  and  guinea 
fowl 

b) Snakes 

X 

c)  Fresh  meat  and  products  from 
species other than above 

X 

X 

X 

X 

Note  that  the  listing  of  a  product  in  Section  II  does  not  mean  that  certificates  will  necessarily  be 
required  as part of agreements reached on equivalence. Such decisions will be made on a product-by 
product basis. 

19 

DOC/ 

DOI/ 

USDA/  USDA/  USDA/ 

NMFS 

FWS 

FDA 

AMS 

APHIS 

FSIS 

Public health certifications  cont'd 

2. Eggs 

a)  Shell  eggs,,  hard  cooked  eggs, 
ethnic  egg  delicacies,  and  imitation 
egg products 

b)  Liquid,  frozen  and  dried  egg 
products 

a) Butter, cheese, frozen desserts, and 
dried milk products 

3. Dairv 

b) Fluid milk 

4.  Seafood 

a) Fish and fishery  products  including 
fish oil, reptiles (except snakes), snails 
and amphibians 

b)  Live  fish  (including  shellfish  and 
molluscs) 

X 

X 

B. 

EUROPEAN  COMMUNITY 

X 

X 

X 

X 

X 

X 

X 

X 

Control  is shared  between  the national  services  in the  individual  Member  States  and  the  European 
Commission.  In this respect the following applies: 

In  terms  of  exports  to  the  U.S.,  the  Member  States  are  responsible  for  control  of  the 
production  circumstances  and  requirements,  including  statutory  inspections,  and 
issuing 
health  certification  attesting to the agreed standards and requirements. 

The  European  Commission  is responsible  for  overall co-ordination,  inspections/audits  of 
inspection  systems  and  the  necessary  legislative  action  to  ensure  uniform  application  of 
standards and requirements within the Single European Market. 

20 

ANNEX III 

LIST OF DISEASES  FOR WHICH REGIONAL FREEDOM  IS  RECOGNISED 

Animal  diseases 

Foot and mouth disease 

Vesicular stomatitis 

Swine vesicular disease 

Rinderpest 

Peste de petits ruminants 

Contagious bovine pleuropneumonia 

Contagious caprine pleuropneumonia 

Bluetongue 

Sheep and goat pox 

African  swine fever 

African  horse sickness 

Classical swine fever 

Enterovirus encephalomyelitis 

Fowl plague (avian  influenza) 

Newcastle Disease 

Pseudorabies/Aujeszky's 

Venezuelan Equine Encephalomeyelitis 

Aquaculture  diseases 

The  list  of  aquaculture  diseases  is  to  be  discussed  further  by  the  Parties  on  the  basis  of  the 

International Aquatic Animal Health Code of the OIE 

21 

ANNEX IV 

ZONING  AND  REGIONALISATION 

The  Parties  have jointly  determined  that  the  following  forms  the  basis  for  Régionalisation  decisions  for  the 

diseases  listed  in  accordance  with  Annex  III.  Each  Party  will  recognise  régionalisation  decisions  taken  in 

accordance with the standard contained within this Annex. 

Animal  Diseases 

In assessing risk from a given proposed  importation  of animals or animal products, three sets of  factors  may 

be considered: 

1. 

2. 

3. 

Source risk  factors. 

Commodity risk  factors. 

Destination risk  factors. 

Source Risk  Factors 

The primary determinant of the risk of importing  disease is the status of the country of origin  in respect of the 

disease  in  question.  However,  declarations  of  disease  freedom  must  be  backed  up  by  effective  surveillance 

programmes. 

The  over-riding  consideration  in  this  context,  therefore,  is  the  quality  of  the  veterinary  infrastructure.  No 

other factors  can be assessed  without  full  confidence  in the veterinary  administration.  In particular,  its  ability 

to detect and control an outbreak of disease and to provide meaningful  certification  is crucial. 

The ability to detect the presence  of disease depends on the surveillance carried out. This surveillance  can  be 

active, passive, or both. 

Active  surveillance  implies  definitive  action  intended  to  identify  the presence  of  disease,  such  as  systematic 

clinical  inspections,  ante  and  post  mortem  examination,  serology  on  farm  or  in  abattoir,  referral  of 

pathological material for  laboratory diagnosis, sentinel animals. 

Passive  surveillance  means  that  the  disease  must-be  compulsorily  notifiable  and  that  there  must  be  a 

sufficiently  high  level  of  supervision  of  the  animals  in  order  to  ensure  mat  the  disease  will  be  observed 

quickly  and  reported  as a suspect. There  must also be a mechanism  for  investigation  and  confirmation,  and a 

high  level of awareness of the disease and  its symptoms by farmers and veterinarians. 

22 

Epidemio-surveillance  may  be  augmented  by  voluntary  and  compulsory  herd/flock  health  programmes, 

particularly those which ensure a regular veterinary presence on the farm. 

Other factors to be considered include: 

disease history 

vaccination history 

controls on movements into the zone, out of the zone and within the zone 

animal identification  and recording 

presence of disease in adjacent  areas 

physical barriers between zones of differing  status 

meteorological conditions 

use of buffer  zones (with or without vaccination) 

presence of vectors and/or reservoirs 

active control and eradication programmes (where appropriate) 

ante and post mortem  inspection. 

On the basis of these factors, a zone, may be  defined. 

The authority  with the responsibility  for  implementing the zoning policy  is in the best position to define  and 

maintain the zone. When there is a high level of confidence  in that authority, the decisions it makes can be the 

basis for trade. 

The zones so defined  may be assigned a risk category. 

Possible categories are: 

low/negligible risk 

medium risk 

high risk 

unknown risk. 

Calculation  of estimates  of risk for  e.g.  live animals may assist  in this categorisation.  Import  conditions  may 

then be defined  for each category, disease and commodity, individually or in groups. 

Low/negligible risk implies that importation  may take place based on a simple guarantee of origin. 

Medium  risk  implies that some combination  of certification  and/or guarantees may be required  before  or  after 

importation. 

High  risk  implies that  importation  will only take  place under  conditions  which  significantly  reduce  the  risk, 

e.g. by additional guarantees, testing or treatment. 

Unknown  risk  implies  that  importation  will  only take place  if the  commodity  itself  is of  very  low  risk,  e.g. 

hides, wool, or under the conditions for "high risk" if the commodity factors warrant. 

Commodity Risk Factors 

These include: 

is the disease transmissible by the commodity? 

could  the  agent  be  present  in  the  commodity  if  derived  from  a  healthy  and/or  clinically 

affected  animal? 

can the preceding factor be reduced, e.g. by vaccination? 

what is the likelihood that the commodity has been exposed to  infection? 

has the commodity been obtained in such a way as to reduce the risk, e.g. deboning? 

- 

has the commodity been subjected to a treatment which inactivates the agent?  . 

Appropriate tests and quarantine will reduce the risk. 

Destination Risk  Factors 

presence of susceptible animals 

presence of vectors 

possible vector-free  period 

, 

preventative measures such as waste food feeding and animal waste rendering  rules 

intended use of product e.g. petfood, human consumption only. 

These  factors  are  inherent  in or  are under  the control of the  importing  country,  and  some  may  therefore  be 

modified  to  facilitate  trade.  These  may,  for  example,  include  restricted  entry  conditions  e.g.  animals  to  be 

confined  to a certain vector free region until the incubation period has passed, or canalisation systems. 

However,  destination  risk  factors  will  also  be taken  into account  by the infected  country  with  respect  to  the 

risk presented by movements from the infected part to the free part of its territory. 

Aquaculture  Diseases 

Pending the development of any specific  provisions to be included in this Annex, the basis for  Régionalisation 

decisions for aquaculture diseases will be the  International  Aquatic Animal  Health Code of the OIE. 

24 

ANNEX V 

SANITARY  MEASURES  RECOGNISED AS  EQUIVALENT 

The following glossary applies to the attached Annex V: 

Yes (1)  The  importing  Party  agrees  that  the  exporting  Party's  measures  achieve  the-  importing  Party's 

appropriate level of sanitary protection 

Yes (2)  The  importing  Party  agrees that the exporting  Party's measures, with  the special  conditions  set  out, 

achieve the importing Party's appropriate level of sanitary protection 

Yes (3)  Equivalence  agreed  in  principle,  subject  to  satisfactory  completion  of  the  actions.  Pending 

completion, trade shall occur on the basis of the special conditions set out 

NE 

E  . 

AI 

ASF 
BSE 

CEM 
CFR 

CSF 

EBL 

EC 

Not evaluated. Trade shall occur on the basis of compliance with the importing Party's requirements. 

Still  evaluating.  Trade  shall  occur  on  the  basis  of  compliance  with  the  importing  Party's 
requirements. 

Avian  Influenza 

African  Swine Fever 
Bovine Spongiform  Encephalopathy 

Contagious Equine Metritis 
Code of Federal Regulations 

Classical Swine Fever (Hog Cholera) 

Enzootic Bovine Leucosis 

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 

ND 
OIE 

Infectious Bovine  Rhinotracheitis 

Newcastle Disease 
Organisation International des Epizooties 

PHSA  Public Health Service Act 
PM 
ScVC 
SVD 

Post Mortem 
Scientific Veterinary Committee 
Swine Vesicular Disease 

Bovine Tuberculosis 
TB 
Transmissible Mink  Encephalopathy 
TME 
Transmissible  Spongiform  Encephalopathy 
TSE 
U.S. 
United States of America 
WTO  World Trade  Organisation 

25 

- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

| 

Trade Conditions 

Equiv 

Special  Conditions 

Actions 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Animal/Public 

EC Standards 

U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

1. Live animals 
Animal health 
- Equidae 

90/426  Annex 
DandC 

9 CFR 92 

for 

the 

each 

EC  to  submit  by  1  July 
EC 
1997, 
testing 
laboratory 
procedures, 
antigens/ 
reagents  used,  audit/quality 
control  program,  external 
control/laboratory  approval 
programme. 

Inter-laboratory 
reference 
testing  and  exchange  of 
samples  between  designated 
EC  and  U.S laboratories  for 
CEM,  glanders,  dourine, 
equine 
piroplasmosis, 
and 
infectious 
equine  viral  arteritis  to  be 
carried out by  1  July  1997. 

anaemia 

to  consider,  by  1 
U.S. 
September 
1997, 
withdrawing requirement  for 
post-import  quarantine  on 
the bases of results. 

U.S. to assess EC request on 
disease  status  for  dourine 
3 
and  glanders  within 
months of EC submission. 

U.S.  to  review  their  CEM 
and 
piroplasmosis 
requirements  by  1  January 
1998. 

9  CFR 
75,91 

71, 

90/426,  92/260, 
93/195,  93/196, 
93/197,94/467 

U.S. to  consider  identifying 
horses  by  passport 
from 
31.12.1997. 

for 
departure 

EC  to  consider  withdrawing 
isolation 
requirement 
before 
for 
permanent  imports  within  6 
months of  the submission  of I 
the 
final  report  on  VS 
outbreak  -

26 

Commodity 

Species 

European Community Exports to the United States 

United States Exports to the European Community 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Trade Conditions 

Equiv 

Special Conditions 

Animal/Public 

EC Standards 

U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

I. Live animals (cont.) animal health 
-  Bovine 

9 CFR 92 

64/432,  72/462, 
90/425 

Animals 

E 

U.S. to  review  BSE  policy 
with  respect to high  and  low 
incidence. 

9  CFR  71,  72, 
73,  77,  78,  80 
91 

72/462 

E 

to  produce  generic 

U.S. 
conditions for EC 

-  Shccp/Goats 

91/68 

9 CFR 92 

E 

to  produce  generic 

U.S. 
conditions for EC 

9  CFR  54,  71, 
79,77 

91/68,97/231 

E 

j 
EC  to review U.S. dossier on I 
1 
bluetongue 

U.S.  to  provide  details  ofj 
RB51 brucellosis vaccine,  fori 
fl 
review by EC 

EC to produce conditions  fori 
1 
U.S. 
EC to review U.S. dossier  onl 
| 
bluetongue 

to 

submit 

scrapie! 
U.S. 
final  | 
programme  when 
review  is  completed.  EC  to J 
1 
comment 

•  Swine 

64/432,  72/462, 
90/425 

9 CFR 92 

E 

to  produce  generic 

U.S. 
conditions for EC 

9  CFR  71,  76, 
77,78, 85 

72/462 

E 

EC to produce  conditions  fori 
| 
U.S. 
EC to  produce conditions  fori 
U.S. 

-

-  Dogs and cats 

92/65 

9 CFR 92 

NE 

92/65 

NE 

—j——————-——— 

•  "Balai" 
animals 

92/65 

9 CFR 92 

NE 

92/65 

NE 

i 

27 

- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

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 

'' 

• 

— 

2. Live poultry and hatching eggs 

Animal health 

90/539, 93/342  9 CFR 92 

to  produce  generic 

U.S. 
conditions 

9  CFR  71,  82, 
145, 147 

90/539, 93/432 
96/482,96/483 

3. Semen 
Animal health 
- Bovine 

88/407 

9CFR98 

E 

to  produce  generic 

U.S. 
conditions for EC 

9CFR 
71,77,78 

88/407,94/577 

E 

- Sheep/Goats 

92/65 

9CFR98 

• Porcine 

90/429 

9CFR98 

E 

E 

to  produce  generic 

U.S. 
conditions for EC 

9 CFR 71,79 

Directive 92/65 

NE 

to  produce  generic 

U.S. 
conditions for EC 

9  CFR  71,  78, 
85 

90/429,93/199 

E 

- Canine 

- Feline. 

92/65 

92/65 

9CFR 98 

NE 

NE 

92/65 

92/65 

NE 

NE 

f 

I 

| 

EC  to  produce  conditions  to 
allow use of new elisa test kill 
| 
for bluetongue 

EC 
to  consider  allowing | 
movement  between  centres I 
third | 
in 
two 
| 
countries 

approved 

EC  to  examine  U.S.  request! 
that CSF tests not be required I 
on  entry  and  exit 
from! 
centres  in  countries  free  ofl 
the disease. 

• 

, 

28 

-  Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Animai/Public 

EC Standards 

U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

|U.  Equine semen, ova and embryos 
Animal health 

Semen 

92/65, 95/307 

9 CFR 98 

NE 

9 CFR 71, 75 

92/65,96/539  NE 

3 

29 

-  Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Trade Conditions 

Equiv 

Special Conditions 

Actjons 

Animal/Public 

EC Standards 

U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

4.  Equine semen, ova and embryos - animal health - cont'd 
9 CFR 98 
- Ova 

92/65,95/294 

NE 

9 CFR 71,75 

92/65,96/540 

NE 

- I-mbryos 

92/65, 95/294 

9 CFR 98 

NE 

9 CFR 71, 75 

92/65,96/540 

NE 

5.  Embrvos 
Animal health 
-  Bovine 

89/556 

9 CFR 98 

E 

to  produce  generic 

U.S. 
conditions for EC. 

9  CFR  71,  77, 
78 

89/556,92/471 

E 

-: 

U.S. to  review  suspension  of 
imports  from  BSE  affected 
countries 

-Ovine/Caprine 

92/65 

9 CFR 98 

NE 

92/65 

NE 

| 

30 

Commodity 

Species 

European Community Exports to the United States 

United States Exports to the European Community 

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 
-Ruminants 

64/432,  72/461, 
72/462 

9 CFR 94 

Yes 2 

Additional  certification 
for 
bovines  from  BSE  affected 
countries 

U.S.  to  review  rules  on  BSE 
to  high/low 
with 
incidence regions 

respect 

9  CFR  53  (in 
the  case  of  an 
outbreak 
of 
exotic disease) 

•IZquidae 

64/432,  72/461, 
72/462 

9 CFR  94 

Yesl 

9 CFR 53 

72/462, 82/426 

Yes 2 

72/462, 82/426 

Yes 2 

3 month residence. 

• 

freedom 

Holding 
from 
brucellosis  for  ovines  and 
caprines 
3 month residence 

-Porcine 

64/432,  72/461, 
72/462 

9 CFR 94 

Yesl 

.  • 

9 CFR 53 

72/462, 82/426 

Yes 2 

3 month residence. 

Holding 
brucellosis 

freedom 

from 

| 

31 

- Commodity 

-  Species 

European Community Exports to the United States 

United States Exports to the European Community 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Animal/Public 

EC Standards 

U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

6. Fresh meat cont'd 
'ublic health 

64/433, 96/22 

9 CFR 301-381, 
416,417 

Yes 3 

listed 

Establishments 
in 
accordance  with  footnote (7), 
and  fulfilling 
the  relevant 
provisions of footnote (1). 

(8) 

Ruminants 
Equidae 
Porcine 
Ovine 
Caprine 

Equivalency  (Yes 2) shall  be 
granted  after  the  U.S.  has 
completed  verification 
of 
veterinary  delivery  systems. 
This 
be 
completed  within  12  months 
of the date of entry  into  force 
of the agreement. 

process 

shall 

9 CFR 301-381, 
416,417 

72/462,  93/158, 
96/22 

Yes 3 

listed 

Establishments 
in 
accordance with footnote (7), 
and 
fulfilling  the  relevant 
provisions  of  footnotes  (2), 
(3) (4) and (5). 

The  EC  shall  evaluate  the 
U.S. residue programme, and 
additional  information  to  be 
submitted  by  the  U.S.,  to 
determine  whether  it  meets 
the  EC  level  of  protection. 
shall  be 
This  evaluation 
completed  within  6  months 
of the entiy into force of this 
Agreement 

he I 
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  to  evaluate  a  U.S.I 
request,  when  submitted,  onl 
continued! 
for 
the  need 
of| 
testing 
trichinae 
' 
horsemcat. 

32 

-Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

Trade Conditions 

Equiv 

Special  Conditions 

Actions 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Animal/Public 

FX Standards  U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

6. Fresh  meat - public health - cont'd 

7. Poultry meat 

Animal health 

91/494,94/438 

9 CFR 94 

Yesl 

Public health 

71/118,  96/22, 
96/23 

9 CFR 381 

Yes 3 

listed 

Establishments 
in 
accordance with footnote (7), 
and  fulfilling  the  relevant 
provisions of footnote (1). 
Post-mortem inspection to be 
carried 
official 
out  by 
inspectors 

Equivalency  (Yes 2)  shall  be 
granted  after  the  U.S.  has 
completed  verification  of 
veterinary  delivery  systems. 
This 
be 
completed within  12 months 
of the date of entry into force 
of the agreement. 

process 

shall 

-j 

Re footnote  5 (e), the results 
of  the 
after 
inspections 
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 

The  EC  shall  evaluate  the 
U.S. residue programme, and 
additional  information  to  be 
submitted  by  the  U.S.,  to 
determine  whether  it  meets 
the  EC  level  of  protection. 
This  evaluation 
shall  be 
completed  within  6  months 
of the entry  into force  of this 
Agreement 

' 

33 

9 CFR 53 

9  CFR  381.1 
381.5 

91/494,93/342 
94/984 
71/118,  96/22, 
96/23,96/712 

Yesl 

Yes 3 

listed 

Establishments 
in 
accordance with footnote (7), 
fulfilling  the  relevant 
and 
provisions  of  footnotes  (2), 
(3), (4) and (6). 

- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Trade Conditions 

Equiv 

Special  Conditions 

Actions 

Animal/Public 

FX Standards 

U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

7. Poultry  meat - public health - cont'd 

standards 

The  EC  shall  evaluate  the 
to 
U.S.  water 
determine whether they meet 
the  EC  level  of  protection. 
This  evaluation 
shall  be 
completed  within  6  months 
of the entry into force of this 
Agreement. 

The  EC  shall  carry  out  a 
scientific review of the use of 
antimicrobial  techniques, and 
in  particular  the  use  of  TSP 
and/  or  organic  acids,  with 
full  participation  of  U.S. 
scientists.  The 
scientific 
review  should  be  completed 
as soon as possible,. 

Equivalency  (Yes  2) shall be 
granted  after  the  EC  has 
completed  verification  of the 
application  of  the  specified 
conditions. This process shall 
be  completed  within  12 
months of the entry into force 
of the agreement. 

34 

- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

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 
Animal health 
• Red Meat 
(ruminants/ 
equidae) 
Pies. 

64/432,  72/461, 
72/462, 80/215 

64/432,  72/461, 
72/462,80/215 

9 CFR 94 

Yes 2 

Additional  certification 
for 
bovines  from  BSE  affected 
countries 

U.S.  to  review  rules  on  BSE 
with 
to  high/low 
incidence regions 

respect 

9 CFR 53 

72/462,97/221  Yes 2 

9 CFR 94 

Yesl 

9 CFR 53 

72/462,97/221  Yes 2 

Poultry 

92/118,  72/462, 
80/215,94/438 

9 CFR  94 

Y e sl 

9 CFR 53 

97/221 

Yes 2 

• Wild game 
and  fanned 
eame 

92/495, 92/45 

9 CFR 94 

Yes 2 

Additional  certification 
for 
bovines  from  BSE  affected 
countries 

U.S.  to  review  rules  on  BSE 
with 
to  high/low 
incidence regions 

respect 

92/495,92/45 
97/221 

NE 

Derived  from  meat  meeting 
the  conditions  of  point  6 
(fresh meat). 

Derived  from  meat  meeting 
the  conditions  of  point  6 
(fresh meat). 

Derived  from  meat  meeting 
the  conditions  of  point  7 
(poultrymeat). 

I 

| 

35 

- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Animal/Public 

FC Standards 

U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

8. Meat  Products  cont'd 

Public  health 
Ruminants  w 
Equidae 
Pigs \ 
Poultry 

77/99, 96/22 

Yes 3 

CFR  301-335, 
354, 
381.1-
381.500 

listed 

Establishments 
in 
accordance with  footnote  (7), 
the  relevant 
and  fulfilling 
provisions of footnote  1. 

9 CFR 301-335, 
354, 
381.1-
381.500 

72/462,  77/99, 
92/118,96/22 

Yes 3 

Equivalency  (Yes  2)shall  be 
granted  after  the  U.S.  has 
of 
completed  verification 
veterinary  delivery  systems. 
This 
be 
completed  within  12  months 
of the date of entry  into  force 
of the agreement. 

process 

shall 

and/or 

Derived  from  meat  meeting 
the  conditions  of  point  6 
7 
(fresh  meat) 
(poultrymeat). 
Establishments 
in 
accordance with footnote (7), 
and 
fulfilling  the  relevant 
provisions  of  footnotes  (2), 
(3) and (4). 

listed 

The  EC  shall  evaluate  the 
U.S. residue programme, and 
additional  information  to  be 
submitted  by  the  U.S.,  to 
determine  whether  it  meets 
the  EC  level  of  protection. 
This  evaluation 
shall  be 
completed  within  6  months 
of the entry into force  of this 
Agreement. 

standards 

The  EC  shall  evaluate  the 
to 
U.S.  water 
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 
shall  be 
completed  within  12 months 
of  the entry  into  forpe  of the 
agreement. 

process 

36 

- Commodity 

- S pee les . 

European Community Exports to the United States 

United States Exports to the European Community 

I 

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 

FFDCA, 
FIFRA, PHSA 
21  CFR  70-82, 
101, 
109, 
110.3-110.93, 
113,  114,  170-
189,  510-529, 
556 
40  CFR  180, 
185 

Existing trade conditions 

77/99,  92/118, 
96/22 

NE 

FFDCA, 
FIFRA, PHSA 
21  CFR  70-82, 
101, 
109, 
110.3-110.93, 
113,  114,  170-
189,  510-529, 
556 
40  CFR  180, 
185 

8. Meat Products - public health - cont'd 
Wild came W 
NE 
77/99, 96/22 

Farmed came (8) 

9. Farmed  game meat 
Animal health 
-Deer 

72/461,  92/118, 
91/495 

9 CFR 94 

Yes 2 

Additional  certification  from 
BSE affected  countries 

U.S.  to  review  rules  on  BSE 
with 
to  high/low 
incidence regions 

respect 

92/118,91/495 
97/219 

NE 

-Rabbit 

Yesl 

-Porcine 

72/461,  92/118, 
91/495 

9 CFR 94 

Yesl 

-Feathered 

92/118,  72/462, 
80/215,94/438 

9 CFR 94 

Yesl 

92/118 

NE 

9 CFR 94 

92/118,97/219 

NE 

1 
J 

37 

• Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Animal/Public 

F.C Standards 

U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

9. Farmed game meat cont'd 
Public health 
(8) 
footnote 
See 

91/495,  96/22, 
97/219 

for  ruminants 

FFDCA, 
FIFRA, PHSA 
21  CFR  70-82, 
101, 
109, 
110.3-110.93, 
113,  170-189, 
510-529,556 
40  CFR  180, 
185 
9 CFR 301-335, 
352,354 

NE 

Existing  trade conditions 

91/495,  96/22, 
97/219 

NE 

FFDCA, 
FIFRA, PHSA 
21  CFR  70-82, 
101, 
109, 
110.3-110.93, 
113, 
510-529,556 
40  CFR  180, 
185 
9 CFR 301-335, 
352,354 

170-189, 

10. Wild game meat 
Animal  health 
-Deer 

92/45 

9 CFR 94 

E 

92/45,97/218 

NE 

-Rabbit 

-Porcine 

92/45 

9 CFR 94 

E 

• 

, 

92/45,97/220 

NE 

] 

, 

38 

- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

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 
-Feathered 

9 CFR 94 

92/45 

£ 

NE 

Existing  trade conditions 

Public health 
See 
(8) 
footnote 
for  ruminants 

96/22, 
92/45, 
96/23,  97/218, 
97/220 

FFDCA, 
FIFRA, PHSA 
21  CFR  70-82, 
101, 
109, 
110.3-110.93, 
170-189,  510-
529,556 
9 CFR 301-335 
40  CFR  180, 
185 

92/45,97/218 

NE 

96/22, 
92/45, 
96/23,  97/218, 
97/220 

NE 

FFDCA, 
FIFRA, PHSA 
21  CFR  70-82, 
101, 
109, 
110.3-110.93, 
170-189,  510-
529, 556 
9 CFR 301-335 
40  CFR  180, 
185 

39 

Commodity 

Species 

European Community Exports to the United States 

United States Exports to the European Community 

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 
-Fish/fisheries 
products 

USDI  &  Title 
50 

91/67 

NE 

-Bivalve 
molluscs/ 
crustaceans 
(excl. live) 
Public health 
-Fish/fisheries 
products 

91/67 

USDI  &  Title 
50 

NE 

91/493,  96/22, 
96/23 

21  CFR  123, 
1240 

Yes 3 

Low  Acid  Canned  Food 
requirement 

USDI  &  Title 
50 

91/67 

USDI  &  Title 
50 

91/67 

NE 

NE 

21  CFR  123, 
1240 

91/493,  95/328, 
96/22,96/23 

Yes 3 

95/328 

U.S.  to  respond,  by  1  July 
detailed 
with 
1997, 
indication  of  how  the  EC 
request  for  equivalence  for 
Low Acid  Canned  Food can 
be  considered. 

By  May  15, EC  to  provide 
(1)  appropriate  information 
and 
on 
documentation 
procedures  for  audit  and 
control  of 
implementation 
by  Member  States,  and  (2) 
information  on  application 
of  HACCP 
in 
Member States. 

systems 

EC  to  evaluate  new  U.S. 
standards if applicable 

U.S. to inform  the EC when 
the  U.S. is ready to have the 
implementation  of 
its 
seafood  HACCP  Regulation 
reviewed. 

EC  to  carry  out  review, 
involving 
necessary 
as 
examination  of  information 
to  be 
and  documentation 
provided 
by  U.S.  on 
procedures  for  audit  and 
control  of  implementation. 
On-site  verification  of U.S. 
system  to  be  carried  out 
within  6  months  of  U.S. 
request. 

' 

40 

- Commodity 

- .Species 

European Community Exports to the United States 

United States Exports to the European Community 

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) 

1 health 

1 

1 

~l 

11. Fisheries products for human consumption - Public Health - cont'd 

- Fisli/fisheries 
products cont'd 

Before  1  September  1997, 
U.S. 
to  conduct  on-site 
verification  of  EC  system 
to  EC 
visit 
(including 
central 
and 
offices 
observation  of  Commission 
audits  of  a  number  of 
Member States). 

to 

indicate 

any 
U.S. 
outstanding 
problems 
following  above  actions  by 
15 October  1997. 

If 

EC. 

The  outcome  of  the  on-site 
verification  to  be  discussed 
on-site 
with 
verification  satisfactory,  the 
equivalence 
determination 
to  be  finalised,  and  any 
necessary  procedures  carried 
out. 

NMFS 
Voluntary 
HACCP  based 
Program 
50 
CFR 260 

Yesl 

to 

indicate 

any 
EC 
problems 
outstanding 
following 
actions 
within  45  days  of  on-site 
verification. 

above 

If 

EC. 

The  outcome  of  the  on-site 
verification  to  be  discussed 
with 
on-site 
verification  satisfactory,  the 
equivalence  determination 
to  be  finalised,  and  any 
necessary procedures carried 
out. 

"Establishments"  do  not 
include "brokers or traders". 

41 

-  Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

— 

1 

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 

-Bivalve 
molluscs/ 
crustaceans 
excl. live) 

91/492, 

National 
Shellfish 
Sanitation 
Programme 

Yes 3 

I Existing  trade conditions 

for 

EC  to  supply  the  raw  data 
used 
scientific 
the 
assessment  on  flesh/water 
testing.  U.S. shall  respond  to 
results 
scientific 
assessment  within  90 days of 
receipts of raw data. 

of 

documentation 

By  May  15,  EC  to  provide 
information 
(1)  appropriate 
' on 
and 
for  audit  and 
procedures 
implementation 
control  of 
by  Member  States,  and  (2) 
information  on  application 
of  HACCP 
in 
Member States. 

systems 

Before  1  September  1997, 
U.S. 
to  conduct  on-sitt 
verification  of  EC  system 
to  EC 
visit 
(including 
and 
offices 
central 
observation  of  Commission 
audits  of  a  number  of 
Member States). 

to 

indicate 

U.S. 
any 
problems 
outstanding 
following  above  actions  by 
15 October 1997. 

91/492 

Yes 3 

Existing trade conditions 

National 
Shellfish 
Sanitation 
Programme 

comparison 
testing 

of 
Joint 
for 
flesh/water 
classification  of  production 
areas. 

U.S.. to  inform  the  EC when 
the U.S.  is ready to have the 
its 
implementation 
seafood  HACCP  Regulation, 
reviewed. 

of 

by  U.S. 

EC  to  carry  out  review, 
necessary 
as 
involving 
examination  of  information 
and  documentation  to  be 
provided 
on 
procedures  for  audit  and 
control  of  implementation. 
On-site  verification  of  U.S. 
system  to  be  carried  out 
within  6  months  of  U.S. 
request. 

to 

indicate 

any 
EC 
problems 
outstanding 
following 
above  '  actions 
within  45  days  of  on-site 
verification. 

42 

- Commodity 

- Species 

European Community Exports to the United States 

Umted States Exports to the European Community 

1 

Trade Conditions 

Equiv 

Special  Conditions 

Actions 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Animal/Public 

EC Standards 

U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

===== 

11. Fisheries products for human consumption - Public Health - cont'd 
-Bivalve 
molluscs/ 
crustaceans 
(excl. 
cont'd 

Live) 

The  outcome  of  the  on-site 
verification  to  be  discussed 
with 
on-site 
verification  satisfactory,  the 
equivalence 
determination 
to  be  finalised,  and  any 
necessary  procedures  carried 
out. 

EC. 

If 

If 

EC. 

The  outcome  of  the  on-site 
verification  to  be  discussed 
with 
on-site 
verification  satisfactory,  the 
equivalence 
determination 
to  be  finalised,  and  any 
necessary  procedures  carried 
out. 

- Aquaculture 
animals and 
products 

91/493,  96/22, 
96/23 

NE 

National 
Shellfish 
Sanitation 
Programme, 
FFDCA, 
FIFRA,  PHSA, 
21  CFR  110.3-
123, 
110.93, 
1240, DVM 

12. Live fish / shellfish  and gametes 
Animal health  91/67 

NE 

91/493,  96/22, 
96/23 

NE 

National 
Shellfish 
Sanitation 
Programme, 
FFDCA, 
FIFRA,  PHSA, 
21  CFR  110.3-
123, 
110.93, 
1240, DVM 

91/67 

NE 

"Establishments"  do  not 
include "brokers or traders". 

43 

- Commodity 

- Species 

European Commumty Exports to the United States 

United States Exports to the European Community 

Trade Conditions 

Equiv 

Special  Conditions 

Actions 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Animal/Public 

IZC Standards  U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

113. Milk and  milk based  products for human  consumption 
Animal health 
-Cattle 
including 
buffalo 

Certification 
FMD affected  regions 

64/432, 92/46 

9 CFR 94 

Yes 2 

to  UHT 

non-FMD 

affected 
For 
countries/regions  a  certificate 
of origin is required. 

for 

to 

U.S. 
double 
acceptable. 

review  whether 
pasteurisation 

9 CFR 77,78 

92/46,95/343 

Yes 2 

TB 
and 
requirements 
treated 

Brucella 
for  non-heat 

EC  to  review  U.S.  TB  and 
Brucella  programmes 

-Sheep 
-Goats 

i 

t 

44 

- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Commumty 

Trade Conditions 

Equiv 

Special  Conditions 

Actions 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Animal/Public 

EC Standards 

U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

3. Milk and  milk based  products for human consumption  cont'd 
'ubiic health 
•UHT-Milk/ 
sterilised 
Milk 

Existing trade conditions. 

Yes 3 

92/46, 
94/71, 
95/340,  95/342, 
96/23, 
96/22, 
97/115,  91/180, 
92/608,  92/118, 
96/90 

FFDCA,FIFRA, 
PHSA  21  CFR 
108, 
70-82, 
110.3-110.93, 
113,  131,  172, 
184,  510-520, 
556, 
1210, 
1240 
40  CFR  180, 
185 

U.S.  to  review  Import  Milk 
Act. 

U.S.  to  respond,  by  1  July 
1997, with detailed  indication 
of  how  the  EC  request  for 
equivalence  for  Low  Acid 
be 
Food 
Canned 
considered. 

can 

Joint 
laboratories to be completed 

assessment 

of 

EC  to  provide  appropriate 
and 
information 
documentation 
on 
for  audit  and 
procedures 
control  of 
implementation 
by  Member  States.  U.S.  to 
review 
information 
provided,  and  to  carry  out 
on-site  verification  of  EC 
system. 

92/46, 
94/71, 
95/340,  95/342, 
95/343,  96/22, 
96723,  97/115, 
91/180,  92/608, 
92/118,96/90 

FFDCA, 
FIFRA, PHSA 
21  CFR  70-82, 
110.3-
108, 
110.93, 
113, 
131,  172,  184, 
510-520,  556, 
1210,1240 
40  CFR  180, 
185 

Yes 3 

EC  requirements  for  somatic 
cell and plate counts 
Certification as per 95/343 

U.S.  to  consider  including 
HACCP  system 
in  dairy 
products 

Joint 
laboratories to be completed 

assessment 

of 

Discussions  on  somatic  cells 
and plate counts to continue 

U.S.  to  provide  appropriate 
and 
information 
on 
documentation 
procedures  for  audit  and 
control of implementation. 
EC  to  review  information 
provided,  and  to  cany  out 
on-site  verification  of  U.S. 
system. 

If 

The  outcome  of  the  on-site 
verification  to  be  discussed 
with  U.S.. 
on-site 
verification  satisfactory,  the 
equivalence  determination 
to  be  finalised,  and  any 
necessary procedures carried 
out 

45 

1 
j-Commodity 

-Species 

European Community Exports to the United States 

United States Exports to the European Community 

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) 

i- 
! health 
l  . 

3. Milk and milk based products for human consumption - public health - cont'd 

•UHT-Miik/ 
sterilised 
Milk cont'd 

-Pasteurised 
products 

92/46, 
94/71, 
95/340,  95/342, 
96/23, 
96/22, 
97/115,  91/180, 
92/608,  92/118, 
96/90 

Pasteurised 
Milk  Ordinance 
for  Grade  A 
Products 
and 
related 
documents 

FFDCA, 
FIFRA, PHSA 
21  CFR  70-82, 
110.3-
.108, 
110.93, 
113, 
131,  133, 135, 
172,  184,  510-
556, 
520, 
1210,1240 
40  CFR  180, 
185 

Yes 3 

Existing trade conditions 

coli 
E 
cheeses) 

requirement 

(for 

If 

EC. 

The  outcome  of  the  on-site 
verification  to  be  discussed 
with 
on-site 
verification  satisfactory,  the 
equivalence 
determination 
to  be  finalised,  and  any 
necessary  procedures  carried 
out. 

can 

The  U.S. to  respond,  by  1 
July  1997, with  a  detailed 
indication  of  how  the  EC 
request  for  equivalence  to 
be 
"Grade  A" 
considered,  and 
to 
the  possibility  of 
allow 
export  of  such  products  to 
the U.S.. 
V.S.  to  review  Import  Milk 
Act. 

thus 

Discussions on differences  in 
finished  product criteria for E 
coli to continue. 

Joint 
laboratories to be completed 

assessment 

of 

Pasteurised 
Milk  Ordinance 
for  Grade  A 
Products 
and 
related 
documents 

FFDCA, 
FIFRA, PHSA 
21  CFR  70-82, 
110.3-
108, 
110.93, 
113, 
131,  133, 135, 
172,  184, 510-
556, 
520, 
1210,1240 
40  CFR  180, 
185. 

92/46, 
94/71, 
95/340,  95/342, 
95/343,  96/22, 
96/23,  97/115, 
91/180,  92/608, 
92/118,96/90 

Yes 3 

EC  requirements  for  somatic 
cell and plate counts 
Certification  as per 95/343 

U.S.  to  consider 
HACCP  system 
products 

including 
in  dairy 

Joint 
laboratories to be completed 

assessment 

of 

Discussions  on  somatic  cells 
and plate counts to continue 

U.S.  to  provide  appropriate 
,  and 
information 
on 
documentation 
procedures  for  audit  and 
control of implementation 

46 

- Commodity 

- Species 

European Commumty Exports to the United States 

United States Exports to the European Community 

1 

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 

-Pasteurised 
products cont'd 

13. Milk and milk based products for human consumption - public health - cont'd 
EC  to  provide  appropriate 
and 
information 
on 
documentation 
for  audit  and 
procedures 
control  of 
implementation 
by Member States 

U.S.  to  review  information 
provided,  and  to  carry  out 
on-site  verification  of  EC 
system. 

If 

EC. 

The  outcome  of  the  on-site 
verification  to  be  discussed 
with 
on-site 
verification  satisfactory,  the 
equivalence 
determination 
to  be  finalised,  and  any 
necessary  procedures  carried 
out 

Pasteurised 
Milk  Ordinance 
for  Grade  A 
Products 
and 
related 
documents 

The  U.S.  to  respond,  by  1 
July  1997,  with  a  detailed 
indication  of  how  the  EC 
request  for  equivalence  to 
be 
"Grade 
considered,  and 
to 
allow 
the  possibility  of 
export  of  such  products  to 
the U.S.. 

thus 

can 

A" 

EC  to  review  information 
provided,  and  to  cany  out 
on-site  verification  of  U.S. 
system. 

If 

The  outcome  of  the  on-site 
verification  to  be  discussed 
on-site 
with  U.S.. 
verification  satisfactory,  the 
equivalence  determination 
to  be  finalised,  and  any 
necessary procedures carried 
out 

47 

Pasteurised 
Milk  Ordinance 
for  Grade  A 
Products 
and 
related 
documents 

- Commodity 

- Species 

European Community Exports to the United States 

, 

u 

United States Exports to the European Community 

Trade Conditions 

Equiv 

Special  Conditions 

Actions 

Trade Conditions 

Equiv 

Special  Conditions 

Actions 

Animal/Public 

EC Standards 

U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

13. Milk and milk based products for human consumption - public health - cont'd 
-Not 
Pasteurised 
(raw or 
thermiscd) 

91756;—547717 
95/340,  95/342, 
97/115,  91/180, 
92/608,  92/118, 
96/23, 
96/22, 
96/90 

Discussions on  ditterences  in 
finished  product criteria for E 
coli to continue. 

Compliance  with  E  coli 
requirement (for cheeses) 

Joint 
laboratories to be completed 

assessment 

Y ê sT 

of 

WUCK, 
FIFRA, PHSA 
21  CFR  70-82, 
108,  110,  113, 
133,  172,  184, 
185,  510-520, 
556,  1240 
40 CFR 180 

EC  to  provide  appropriate 
and 
information 
on 
documentation 
for  audit  and 
procedures 
control  of 
implementation 
by Member States. 

U.S.  to  review  information 
provided,  and  to  carry  out 
on-site  verification  of  EC 
system.  The  outcome  of  the 
on-site  verification 
to  be 
discussed with EC. If on-site 
verification  satisfactory,  the 
equivalence 
determination 
to  be  finalised,  and  any 
necessary  procedures carried 
out. 

The  U.S. 
to  consider  a 
dossier,  to  be  submitted  by 
the  EC, 
for  cheese  not 
matured  for  more  than  60 
days,  and  thus  to  allow  the 
possibility  of export  of  such 
products to the U.S.. 

Prohibition  on  products  not 
matured  for  more  than  60 
days  at  temperature  above 
35°F (+2°C). 

FFDCA, 
FIFRA, PHSA 
21  CFR  70*82, 
108,  110,  113, 
133,  172,  184, 
185,  510-520, 
556,1240 
40 CFR  180 

92/46, 
94/71, 
95/340,  95/342, 
95/343,  97/115, 
91/180,  92/608, 
92/118,  96/22, 
96/23,  96/90 

YêsT 

with 

Compliance 
EC 
requirements  for somatic celt 
and plate counts 
Certification as per 95/343 

TTS^oconsiaePTncluding J 
HACCP  system 
in  dairy | 
products. 

of 
Joint 
laboratories to be completed. 

assessment 

Discussions  on  somatic  cells 
and plate counts to continue. 

U.S.  to  provide  appropriate 
and 
information 
documentation 
on 
for  audit  and 
procedures 
of 
control 
implementation.EC 
to 
review 
information 
provided,  and  to  carry  out 
on-site  verification  of  U.S. 
system. 

If 

The  outcome  of  the  on-site 
verification  to  be  discussed 
with  VS.. 
on-site 
verification  satisfactory,  the 
equivalence  determination 
to  be  finalised,  and  any 
necessary procedures carried 
out 

•J 

48 

- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

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 

92/118,64/432 

14. Milk and  milk based  products not for human  consumption 
Animal  health 
-Cattle 
including 
buffalo 
-Sheep 
-Goats 

For 
affected 
regions, a certificate  of origin 
is required. 
For  FMD  affected  regions, 
certification  to UHT 

9 CFR 94.16 

non-FMD 

Yes 2 

to  review 

U.S. 
if  double 
pasteurisation  of  products 
from FMD affected  regions is 
acceptable. 

9 CFR 77,78 

92/118,  95/341 

NE 

-

All-  pasteurised 
or  UHT  or 
Sterilised 
-Unpasteurised 
colostrum 
for 
pharmaceu 
tical use (l0) 

92/118 

9 CFR 94.16 

NE 

9 CFR 77, 78 

92/118 

NE 

1 

| 

| 

49 

- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

1 

1 

Animal/Public 

EC Standards 

U.S. Standards 

(Cat) 

health  . 

U.S.  Standards  EC Standards 

(Cat) 

^ ^ = S = a B S = S S S = S S B ^ xJ 

15. Minced  meat 
Animal health 
- Ruminants 

64/432,  72/461, 
72/462 

9 CFR 94 

Yes 2 

Additional  certification 
for 
bovines  from  BSE  affected 
countries. 

U.S.  to  review  rules  on  BSE 
with 
to  high/low 
incidence regions. 

respect 

- Pigs 

64/432,  72/461, 
72/462 

9 CFR 94 

Yesl 

Public health 

VS)— 

94/65 

9 CFR 301-381 

Yes 3 

. 
Ruminants 
Pigs 

listed 

Establishments 
in 
accordance with  footnote  (7), 
and  fulfilling 
the  relevant 
provisions of footnote (1). 

Equivalency  shall  be  granted 
after  the  U.S.  has  completed 
of  veterinary 
verification 
delivery 
This 
process  shall  be  completed 
within  12 months  of the  date 
of  entry  into  force  of  the 
agreement. 

systems. 

72/462 

NE 

72/462 

NE 

9 CFR 301-381 

94/65,97/29 

Yes 3 

Derived  from  meat  meeting 
the  conditions  of  point  6 
(fresh meat). 

listed 

in 
Establishments 
accordance with  footnote  (7), 
and 
the  relevant 
provisions  of  footnotes  (2), 
(3) and (4). 

fulfilling 

• 

The  EC  shall  evaluate  the 
U.S. residue programme, and 
additional  information  to  be 
submitted  by  the  U.S.,  to 
determine  whether  it  meets 
the  EC  level  of  protection. 
This  evaluation 
shall  be 
completed  within  6  months 
of the entry  into  force  of this 
Agreement. 

standards 

The  EC  shall  evaluate  the 
U.S.  water 
to 
determine whether  they meet 
thé  EC  level  of  protection. 
This  evaluation 
shall  be 
completed  within  61 months 
of the entry  into  force  of this 
Agreement. 

50 

- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Trade Conditions 

Equiv 

Special  Conditions 

Actions 

Animal/Public 

EC Standards 

U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

1 

I 

1 

15. Minced meat - public health - cont'd 

16. Meat  preparations 
Animal health 
-Ruminants 

64/432,  72/461, 
72/462 

9 CFR 94 

Yes 2 

Additional  certification 
for 
bovines  from  BSE  affected 
countries. 

U.S.  to  review  rules  on  BSE 
with 
to  high/low 
incidence regions. 

respect 

72/462 

NE 

-Equidae 

-Pigs 

64/432,  72/461, 
72/462 

9 CFR 94 

Yesl 

92/118,  72/462, 
80/215,94/438 

9 CFR 94 

Yesl 

-Poultry /  Wild 
game  /  Fanned 
game 

72/462 

NE 

91/494,  93/342, 
94/984 

NE 

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. 

| 
I 

51 

• 

- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

I 

Trade Conditions 

Equiv 

Special  Conditions 

Actions 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Animal/Public 

EC Standards 

U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

16. Meat  preparations  cont'd 
Public health 
Ruminants (t>> 
Equidae 
Pigs 
Poultry 

94/65 

9 CFR 301-381  Yes 2/3  Establishments 

listed 

in 
accordance with  footnote  (7), 
the  relevant 
and  fulfilling 
provisions of footnote (1). 

9 CFR 301-381  94/65,97/29 

Yes 3 

Equivalency  shall  be  granted 
after  the  U.S.  has  completed 
veterinary 
of 
verification 
delivery 
This 
systems. 
process  shall  be  completed 
within  12 months  of  the  date 
of  entry  into  force  of  the 
agreement. 

Derived  from  meat  meeting 
the  conditions  of  point  6 
7 
(fresh  meat) 
(poultrymeat). 

and/or 

listed 

Establishments 
in 
accordance with footnote (7), 
fulfilling  the  relevant 
and 
provisions ' of  footnotes  (2), 
(3) and (4). 

The  EC  shall  evaluate  the 
U.S. residue programme, and 
additional  information  to  be 
submitted  by  the  U.S.,  to 
determine  whether  it  meets 
the  EC  level  of  protection. 
This  evaluation 
shall  be 
completed  within  6  months 
of the entry into force of this 
Agreement. 

standards 

The  EC  shall  evaluate  the 
U.S.  water 
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 
be 
completed  within  12 months 
of  the entry  into  force  of the 
agreement. 

process 

shall 

52 

- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Animal/Public 

EC Standards 

U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

1 

1 

-, 

16. Meat preparations - public health - cont'd 
Wild name W 

94/65 

NE 

Existing trade conditions 

:armed game (S) 

FIFRA, 
FFDCA, PHSA 
21  CFR  70-82, 
101, 
109, 
110.3-110.93, 
113,  170-189, 
510-529,556 
40  CFR  180, 
185 

94/65 

NE 

FIFRA, 
FFDCA, PHSA 
21  CFR  70-82, 
101, 
109, 
110.3-110.93, 
113, 
510-529,556 
40  CFR  180, 
185 

170-189, 

— - —i 

" 

' 

' 

i 

i 

. 

n 

i  i 

,, 

.- 

.i  — 

— _ • _ . —_ 

i 

_ —— 

* " " ~ "3 

17. Animal casings for human  consumption 
Animal health 
-Cattle 

9 CFR 96 

Yes 2 

92/118,  64/432, 
72/461,72/462 

Non-comminglement 
footnote 9). 

(see 

trade  allowed 

No 
countries affected  by BSE. 

for 

-Pigs 

92/118,  64/432, 
72/461,72/462 

9 CFR 96 

Yes 2 

Non-comminglement 
footnote 9). 

(see 

attesting 

to 
Certification 
process and origin for casings 
free 
originating 
countries/regions 
but 
processed 
in  ASF  affected 
country/region. 

in  ASF 

U.S.  to  review  rules  on  BSE 
with 
to  high/low 
respect 
incidence regions. 
U.S.  to  review  94.8(a)(i)(v) 
of 
non-
comminglement 
U.S.  to  review  94.8(a)(i)(v) 
of 
non-
CFR 
comminglement. 

CFR 

for 

for 

92/118 
94/187 

NE 

92/118 
94/187 

NE 

| 

• 

53 

1 
- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Commumty 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Animal/Public 

EC Standards 

U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

17. Animal casings for human consumption - animal health - cont'd 

•Sheep 
•Goats 

92/118,  64/432, 
72/461,72/462 

9 CFR 96 

Yes 2 

Non-comminglement 
footnote 9). 

(see 

U.S.  to  review  94.8(a)(i)(v) 
of 
non-
CFR 
comminglement. 

for 

92/118 
94/187 

NE 

trade 

No 
countries affected  by BSE 

allowed 

for 

attesting 

Certification 
to 
process  and  country  of origin 
in 
for  casings  originating 
but 
BSE 
processed 
in  BSE  affected 
country. 

countries 

free 

Public health 

77/99 

NE 

FFDCA, 
FIFRA, PHSA 
21  CFR  70-82, 
101, 
109, 
110.3-110.93, 
113,  114,  170-
189,  510-529, 
556  40  CFR 
180,185 

NE 

77/99,  92/118 
Draft  Decision 
to 
notified 
WTO 

FFDCA, 
FIFRA, PHSA 
21  .CFR  70-82, 
101, 
109, 
110.3-110.93, 
113,  114,  170-
189,  510-529, 
556 
40  CFR 
180,185 

1 

1 

1 

54 

1 
- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

Trade Conditions 

Equiv 

Special  Conditions 

Actions 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

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 
•Cattle 

9 CFR 96 

Yes 2 

92/118,64/432 
72/461,72/462 

Non-comminglement 
footnote 9). 

(sec 

U.S.  to  review  rules  on  BSE 
with 
to  high/low 
respect 
incidence regions. 

92/118 
94/1^7 

NE 

trade 

No 
countries affected  by BSE 

allowed 

for 

-Pigs 

92/118,64/4327 
2/461,72/462 

9 CFR 96 

Yes 2 

Non-comminglement 
footnote 9). 

(see 

-Sheep 
-Goats 

92/118,64/4327 
2/461,72/462 

9 CFR 96 

Yes 2 

attesting 

in  ASF 

Certification 
to 
process and origin for casings 
free 
originating 
but 
countries/regions 
processed 
in  ASF  affected 
country/region. 
Non-comminglement 
footnote 9). 

(see 

trade 

No 
countries affected  by BSE. 

allowed 

for 

attesting 

Certification 
to 
process and  country of origin 
in 
for  casings  originating 
BSE 
but 
processed 
in  BSE  affected 
country. 

countries 

free 

U.S.  to  review  94.8(a)(i)(v) 
non-
of 
comminglement 

CFR 

for 

U.S.  to  review  94.8(a)(i)(v) 
of 
non-
comminglement 

CFR 

for 

U.S.  to  review  94.8(a)(i)(v) 
of 
non-
comminglement 

CFR 

for 

92/118 
94/187 

NE 

92/118 
94/187 

NE 

1 

1 

| 
1 

'• 

55 

- Commodity 

-  Species 

European Community Exports to the United States 

United States Exports to the European Community 

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 
Animal  health 
-Cattle 
-Sheep 
-Goats 

92/118,  72/461, 
72/462 

! 

TV 

- P i gs 

9  CFR  95.5, 
95.6 

Yesl 

120. Canned  petfood  containing high/low  risk  material 

- 

92/118 
97/168 

E 

Containing 

mammalian 
.material 

92/118 
90/667 
92/562 

92/118 
90/667 
92/562 

Containing 
non-

only 
mammalian 
material 

9 CFR 94,95 
FFDCA, FIFRA 
21  CFR  110.3-
110.93, 
507-
509,  570, 573-
589 

99 CFR 94,95 
FFDCA, FIFRA 
21  CFR  110.3-
507-
110.93, 
509,  570, 573-
589 

Yes 2 

rules 

Special 
for  BSE 
countries.  Shelf  stable  for 
remainder. 

U.S.  to  review  rules  on  BSE 
to  high/low 
with 
incidence regions. 

respect 

FFDCA, FIFRA 
21  CFR  110.3-
110.93, 
507-
509,  570, 573-
589 

92/118 
94/309 
96/449 
97/199 

Yes 2 

Shelf stable for remainder. 

FFDCA, FIFRA 
21  CFR  110.3-
110.93, 
507-
509,  570, 573-
589 

92/118 
94/309 
96/449 
97/199 

Establishments 
shall  have 
been validated by the U.S. for 
alternative  heat 
treatment 
including  30  day  freedom 
from Clostridia 

• 

to 

EC 
salting requirement 

identify  basis 

1 

fori 
| 

EC to examine  U.S. claim to | 
be BSE  free. 

EC  to  consider  alternative! 
guarantees  for  mammalian 
material, 
including  U.S. 
proposal  to  remove  all  risk 
material  of  known  U.S. TSE 
species from petfood. 

56 

- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

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 

Containing 

21. Canned petfood containing only low risk material 
rules 
92/118,90/667  9  CFR  94,  95 
FFDCA, FIFRA 
21  CFR  110.3-
507-
110.93, 
509,  570,  573-
589 

mammalian 
material 

Yes 2 

for 

Special 
BSE 
countries.  Shelf  stable  for 
remainder. 

. Containing 
non-
' 

- 
only 
mammalian 
material 

92/118,90/667  9 CFR 94,  95 

Yes 2 

Shelf stable. 

FFDCA, FIFRA 
21  CFR  110.3-
507-
110.93, 
509,  570,  573-
589 

U.S.  to review  rules  on BSE 
with 
to  high/low 
incidence regions 

respect 

92/118,94/309 
96/449,97/199 

92/118,94/309 
96/449,97/199 

FFDCA, FIFRA 
21  CFR  110.3-
110.93, 
507-
509,  570,  573-
589 

FFDCA, FIFRA 
21  CFR  110.3-
110.93, 
507-
509,  570,  573-
589 

Establishments 
shall  have 
been validated by the U.S. for 
alternative  heat 
treatment 
including  30  day  freedom 
from Clostridia 

22. Dry and semi moist petfood containing only low risk material 

Yes 2 

Restrictions 
countries 

for 

92/118 
94/309 

9 CFR 94,  95 
FFDCA, FIFRA 
21  CFR  110.3-
507-
110.93, 
509,  570,  573-
589 

BSE  U.S. to examine EC 90° core 
temperature  requirement  as 
sufficient 
providing 
against  FMD, 
guarantees 
CSF,SVD,ASFandND. 
U.S. to review rules on BSE 

FFDCA, FIFRA 
21  CFR  110.3-
110.93, 
507-
509,  570,  573-
589 

92/118,94/309 
96/449,97/199 

Î Establishments  shall  have 
been validated by the U.S. for 
alternative  heat 
treatment 
including  30  day  freedom 
from Clostridia 

1 

-

57 

1 
-  Commodity 

-  Species 

European Community Exports to the United States 

United States Exports to the European Community 

j 

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 
. 
< 

1 

H  -, 
—  ' 
92/118,94/309 

123. Dry and semi moist petfood containing high/low risk material 
1 
9 CFR 94,  95 
FFDCA, FIFRA 
21  CFR  110.3-
110.93, 
507-
509,  570, 573-
589 

Contain 
m mal i an 
terial 

Restrictions 
countries 

ma 
ma 

~ 
Yes 2 

inc 

>• 
for 

. . .. 

1  ~ 

1 .. 

-. 

~ ~^  1. 
BSE  U.S.  to  examine  EC  90°  C 
core temperature  requirement 
as 
sufficient 
guarantees 
against  FMD, 
CSF.SVD.ASFandND. 

providing 

U.S.  to  review  rules  on  BSE 
with 
to  high/low 
respect 
incidence regions. 

92/118,94/344 
96/449,97/199 

FFDCA, FIFRA 
21  CFR  110.3-
110.93, 
507-
509,  570, 573-
589 

EC to  examine  U.S. claim to 
be BSE free. 

EC  to  consider  alternative 
for  mammalian 
guarantees 
material, 
including  U.S. 
proposal  to  remove  all  risk 
material  of  known  U.S. TSE 
species  from  petfood. 

92/118,94/309 

Containing 
non-

only 
mammalian 
material 

Yesl 

9 CFR 94,  95 
FFDCA, FIFRA 
21  CFR  110.3-
110.93, 
507-
509,  570, 573-
589 

U.S.  to  examine  EC  90°  C 
core temperature  requirement 
as 
sufficient 
providing 
guarantees against ND. 

FFDCA, FIFRA 
21  CFR  110.3-
110.93, 
507-
509,  570, 573-
589 

92/118,94/344 
97/199 

Establishments 
shall  have 
been validated by the V.S.  for 
alternative  heat 
treatment 
including  30  day  freedom 
from Clostridia 

58 

- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Trade Conditions 

Equiv 

Special  Conditions 

Actions 

J 

1 

Animal/Public 

EC Standards 

U.S. Standards 

(Cat) 

U.S.  Standards  EC Standards 

(Cat) 

health 

for 

for 

BSE 

BSE 

Yesl 

Yes 2 

Yes 2 

91/495 

respect 

9 CFR 95 

9 CFR 95 

9 CFR 95 

Restrictions 
countries. 

Restrictions 
countries. 

92/118,80/215 
72/462, 94/438 

64/432 
72/461 
80/215 
72/462 

U.S.  to  review  rules  on  BSE 
with 
to  high/low 
incidence regions. 

24. Bones and  bone products for human  consumption  ("other products" as defined  in  77/99/EEC) 
Animal  health 
Fresh 
meat 
(ruminants, 
horses, pigs) 
Farmed  game -
pigs, deer 
Fresh  meat  -
poultry 
Feathered 
farmed 
wild same 
Wild  Game, 
Pics Deer 
Public health 
•Ml 
IM 
• 
All species 
Feathered, 
farmed 
wild game 

U.S.  to  review  rules  on  BSE 
with 
to  high/low 
incidence regions. 

U.S.  to  review  rules  on  BSE 
with 
to  high/low 
incidence regions. 

64/433,  77/99, 
92/118 

Restrictions 
countries. 

92/45 
91/495 

77/99,92/118 

9 CFR 95 

9 CFR 95 

9 CFR 95 

and 

and 

respect 

respect 

Yes 2 

92/45 

Yesl 

BSE 

NE 

NE 

for 

72/462 
97/221 

91/495 

92/118 

92/45 
91/495 

92/45 

FIFRA, 
FFDCA, 
21  CFR  70-82, 
108, 
109, 
110.3-110.93, 
113,  170-189, 
510-529/556 

77/99,92/118 

77/99,92/118 
Draft  Decision 
to 
notified 
WTO 

FIFRA, 
FFDCA, 
21  CFR  70-82, 
108, 
109, 
110.3-110.93, 
113, 
510-529,556 

170-189, 

NE 

NE 

NE 

NE 

NE 

NE 

NE 

EC  to  consider  establishing! 
\ 
conditions. 

59 

j - Commodity 

J- Species 

European Community Exports to the United States 

United States Exports to the European Community 

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 
Ycsl 
Animal health  96/239 

9CFR95 

9 CFR  53 

94/446 

NE 

26. Processed  animal protein  for human  consumption 
Animal  health 
Fresh 
meat 
(•/uminants, 
equidae, pigs) 

64/432,72/461 
80/215,72/462 

Not  accepted 
countries. 

9 CFR 95 

Yes 2 

from  BSE 

U.S.  to  review  rules  on  BSE 
with 
to  high/low 
incidence regions. 

respect 

72/462,97/221 

NE 

Farmed  game -
nigs, deer 
Fresh  meat  -
poultry 
Feathered 
farmed 
wild name 
Wild  Game, 
Pigs Deer 

and 

91/495 

9 CFR 95 

Yes 2 

Not  accepted 
countries. 

from  BSE 

U.S.  to  review  rules  on  BSE 
to  high/low 
with 
incidence regions. 

respect 

92/118,80/215 
72/462,94/438 

9 CFR 95 

Yesl 

92/45 
91/495 

9 CFR 95 

Yesl 

92/45 

9 CFR 95 

Yes 2 

Not  accepted 
countries. 

from  BSE 

U.S.  to  review  rules  on  BSE 
with 
to  high/low 
respect 
incidence regions. 

91/495 

NE 

92/118 

NE 

92/45 
91/495 

NE 

92/45 

NE 

EC to  examine  U.S. claim to 
be BSE free. 

EC  to  consider  alternative 
guarantees  for  mammalian 
material, 
including  U.S. 
proposal  to  remove  all  risk! 
material  of  known  U.S. TSEI 
| 
species from  petfood.. 

I 

60 

1 
J - CiMiunoditv 
1 

i 

-  'sj'OsU'S 

European Community Exports to the United States 

United States Exports to the European Community 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Trade Conditions 

Equiv 

Special  Conditions 

Actions 

Animiil'Tulilii; 

I'C Standards 

U.S. Standards 

(Cat) 

U.S.  Standards  EC Standards 

(Cat) 

j • 
ihcilih 
II 

26. Processed  animal protein  for  human  consumption  cont'd 
Public  health 
All species (A> 
Feathered. 
farmed 
wild game 

77/99,92/118 

and 

77/99 

Yesl 

NE 

(<s) 

•i 

i 

FIFRA,  PHSA, 
FFDCA, 
21  CFR  70-82, 
108, 
109, 
110.3-110.93, 
113,  170-189, 
510-529,556 

I 

27. Processed  animal protein  not for human consumption 
Containing material of manu 
Ruminants 

Yes 2 

Not  accepted 
countries. 

92/118 
90/667 

from  BSE 

95 

malian origin 
9  CFR 
FIFRA, 
FFDCA, 
21  CFR  110.3-
110.93, 
507-
509,  570,  573-
589 

1 Non-ruminants 

92/118 
90/667 

Yes 3 

95 

9  CFR 
FIFRA, 
FFDCA, 
21  CFR  110.3-
110.93, 
507-
509,  570,  573-
589 

77/99,92/118 

NE 

NE 

77/99,92/118 
Draft  Decision 
notified 
to 
WTO 

FIFRA,  PHSA, 
FFDCA, 
21  CFR  70-82, 
108, 
109, 
110.3-110.93, 
113, 
510-529,556 

170-189, 

U.S.  to  review  rules  on  BSE 
with 
to  high/low 
incidence regions. 

respect 

FIFRA, 
FFDCA, 
21  CFR  110.3-
110.93, 
507-
509,  570,  573-
589 

FIFRA, 
FFDCA, 
21  CFR  110.3-
507-
110.93, 
509,  570,  573-
589 

90/667,92/118 
92/562,94/344 
96/449,97/198 

NE 

92/118,  90/667, 
96/449 

NE 

Establishments 
shall  have 
been validated by the U.S. for 
treatment 
alternative  heat 
freedom 
including  30  day 
from Clostridia 

| 

. 

' 

1 
EC to examine  U.S. claim  to | 
j 
be BSE 

free. 

EC  to  consider  alternative 
for  mammalian 
guarantees 
material, 
including  U.S. 
proposal  to  remove  all  risk 
material  of  known  U.S. TSE 
species  from  petfood. 

i 

61 

- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

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 

27. Processed animal protein  not for human consumption cont'd 
Containing only material of non mammalian origin 
Poultry 
fish 

and  92/118,90/667  9 CFR 95 

Yesl 

Non-ruminants  92/1 IS, 90/667  9 CFR 95 

Yesl 

28. Scrum of eq uidae 
Animal health  92/118,94/143  9 CFR 95,122  NE 

90/667,92/118 
92/562,  94/344, 
97/198 

NE 

92/118,90/667  NE 

Establishments 
shall  have 
been validated by the U.S. for 
treatment 
alternative  heat 
including  30  day  freedom 
from  Clostridia. 

92/118,94/143  NE 

29. Blood and  blood products intended for human consumption 
Animal health 
Fresh 
meat 
(ruminants, 
equidac, pigs) 

64/432, 72/461 
80/215,72/462 

BSE rules for ruminants. 

9 CFR 95,122 

E 

Farmed  game -
pigs, deer 
Fresh  meat  -
poultry 

91/495 

9 CFR 95,122 

Yes 2 

BSE rules for ruminants. 

92/118,80/215 
72/462, 94/438 

9 CFR 95, 122 

Yesl 

U.S.  to  review  rules  on  BSE 
with 
to  high/low 
respect 
incidence regions. 

9 CFR 53 

72/462 
97/221 

to  produce  generic 

U.S. 
conditions for EC 
U.S.  to  review  rules  on  BSE 
with 
to  high/low 
incidence regions. 

respect 

91/495 

92/118 

NE 

NE 

NE 

J 

1 

I 

I 

62 

| 

8 

[ 

1 

EC  to  consider  establishing! 
j 
conditions. 

- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

Trade  Conditions 

Equiv 

Special  Conditions 

Actions 

Trade Conditions 

Equiv 

Special  Conditions 

Actions 

Animal/l'ublic 

HC Standards  U.S. Standards 

(Cat) 

U.S.  Standards  EC Standards 

(Cat) 

health 

Yesl 

and 

92/45,91/495 

9 CFR 95,  122 

29. Blood and  blood  products intended for human  consumption  - Animal health - cont'd 
Feathered 
fanned 
wild game 
Wild  Game, 
Pius Deer 
Public health 

9 CFR 95,122 

92/45 

77/99 

Yesl 

NE 

9 CFR 301-381, 
416, 
417 
FFDCA, 
FIFRA, 21 CFR 
110.3-110.93, 
507-509,  570, 
573-589 

NE 

NE 

NE 

92/45 
91/495 

92/45 

77/99,92/118 
Draft  Decision 
notified 
to 
WTO 

9 CFR 301-381, 
416, 
417 
FFDCA, 
FIFRA, 21 CFR 
110.3-110.93, 
507-509,  570, 
573-589 

30. Blood  and  blood  products not intended for human consumption 
Animal health  92/183,92/118  9 CFR 95.4, 

BSE rules for ruminants. 
Permit required 

Yes 2 

122 

U.S.  to  review  rules  on  BSE 
with 
to  high/low 
incidence regions. 

respect 

9 CFR  53 

92/183,92/118  Yes 2 

Bluetongue 
.requirements. 

treatment  EC  to  consider  use  of  tests 
for  Bluetongue  in  place  ofj 
treatment 

63 

- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Commumty 

Trade Conditions 

Equiv 

Special  Conditions 

Actions 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

1 

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 
meat 
Fresh 

BSE rules for ruminants. 

9 CFR 95 

Yes 2 

J (ruminants. 

horses,  pigs) 

64/432 
72/461 
80/215 

Fanned 

game 

-

91/495 

9 CFR 95 

Yes 2 

BSE rules for ruminants. 

pigs,  deer 

Fresh 

meat 

poultry 

Feathered 

farmed 

and  wild  game 

92/118 
80/215 
94/438 
92/45 
91/495 

9 CFR 95 

Yesl 

9 CFR 95 

Yesl 

Wild  G a m e.  Pigs 

92/45 

9 CFR 95 

Yes 2 

BSE rules for ruminants: 

i Deer 

Public health 
All species ^' 
Feathered, 
farmed 

and 

• i. 

•  ( S) 

wild game 

77/99,92/118 

77/99 

NE 

NE 

9 CFR 301-381, 
416, 
417 
FIFRA,  PHSA, 
FFDCA, 
21  CFR  70-82, 
108, 
109, 
110.3-110.93, 
113,  170-189, 

j 510-529, 556 

^ 

U.S.  to  review  rules  on  BSE 
with 
to  high/low 
respect 
incidence regions. 

U.S.  to  review  rules  on  BSE 
with 
to  high/low 
incidence regions. 

respect 

* 

U.S.  to  review  rules  on  BSE 
with 
to  high/low 
incidence regions. 

respect 

72/462 
97/221 

NE 

91/495 

NE 

92/118 

NE 

92/45 
91/495 

92/45 

NE 

NE 

77/99,92/118 

NE 

NE 

77/99,92/118 
Draft  Decision 
to 
notified 
WTO 

9 CFR 301-381, 
416, 
417 
FIFRA,  PHSA, 
FFDCA, 
21  CFR  70-82, 
108, 
109, 
110.3-110.93, 
113, 
510-529,556 

170-189, 

• 

64 

- Commodity 

- Species 

European Community Exports to the United States 

— — • — — — — —— 

' 

' —' 

' —'—» 

United States Exports to the European Community 

Trade Conditions 

Equiv 

Special  Conditions 

Actions 

Trade Conditions 

Equiv 

Special Conditions 

Actions 

Animal/Public 

EC Standards 

U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

32. Lard  and  rendered  fats  not intended for human  consumption 

9 CFR 95 

Yes 2 

BSE rules for ruminants. 

92/118 
90/667 
72/461 

U.S. to  review  rules  on  BSE 
to  high/low 
with 
incidence regions. 

respect 

NE 

92/118 
Draft  Decision 
notified 
to 
WTO 

EC to review requirements to 
of 
consider 
alternative  heat 
treatment 
systems. 

inclusion 

to 

review 

EC 
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"18 

]9CFR95,i22  Yesl 

9 CFR 53 

92/118 

EC  to  consider  laying downl 
certification  requirements  for) 
imports 

34. Apiculture  products  for  apiculture 
Animal  health  |9 2 / 1 18 

35. Game  trophies 
Animal  health  92/118 

9 CFR 95 

Yesl 

92/118,94/860  NE 

9 CFR 53 

92/118 
96/590 

65 

Commodity 

Species 

European Community Exports to the United States 

United States Exports to the European Commumty 

Trade Conditions 

Equiv 

Special  Conditions 

Actions 

Trade Conditions 

Equiv 

Special  Conditions 

Actions 

Animnl/Public 

EC Standards 

U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

36. Manure 
Animal health  P1 18 

9 CFR 95 

37. Wool, feathers  and  hair 
Animal health 

U.S.  to  provide  temperature 
for  manure 
requirements 
from  regions  affected 
by 
serious transmissible disease 

9 CFR 53 

92/118 

92/118 

92/118 

9 CFR 95 

9 CFR 95 

AVool 
-Pigbristlc 

Public health 

38. Honey 
Animal  health 

Public health 

92/118 

Yesl 

Yesl 

NE 

NE 

NE 

NE 

NE 

NE 

NE 

NE 

r 

9 CFR 53 

9 CFR 53 

92/118 

92/118 
94/435 

FFDCA, PHSA 
21 
CFR 
1240.70 

-. 

92/118 

FFDCA, 
FIFRA, PHSA 
21  CFR  70-82, 
109, 
110.3-
110.93, 
520.182, 
520.1660d 

FFDCA, PHSA 
21 
CFR 
1240.70 

FFDCA, 
FIFRA, PHSA 
21  CFR  70-82, 
109, 
110.3-
110.93, 
520.182, 
520.1660d 

i 

! 

| 

1 

66 

- Commodity 

- Species 

European Community Exports to the United States 

United States Exports to the European Community 

Trade Conditions 

Equiv 

Special  Conditions 

Actions 

Trade Conditions 

Equiv 

Special Conditions 

Actions  • 

Animnl/Public 

EC Standards 

U.S. Standards 

(Cat) 

health 

U.S.  Standards  EC Standards 

(Cat) 

39. Frog's  legs 
Animal  health 

Public health 

92/118,96/340  FFDCA, 

NE 

FIFRA, PHSA 
21  CFR  70-82, 
110.3-
108, 
110.93, 
113, 
114,123,1240 

40. Snails for  human  consumption 
Animal  health 

Public health 

92/118,96/340  FFDCA, 

NE 

FIFRA, PHSA 
21  CFR  70-82, 
110.3-
108, 
113, 
110.93, 
114,123,1240 

-

FFDCA, 
FIFRA, PHSA 
21  CFR  70-82, 
110.3-
108, 
110.93, 
113, 
114,123,1240 

FFDCA, 
FIFRA, PHSA 
21  CFR  70-82, 
110.3-
108, 
113, 
110.93, 
114,123,1240 

92/118,96/340  NE 

EC  to  review  U.S.  HACCP j 
rules when submitted. 

| 

92/118,96/340  NE 

• 

| 

67 

Commoditv 

S;vcies 

European Community Exports to the United States 

United States Exports to the European Community 

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-,—: 
Yes 2 
/viumal health  90/539 

9 CFR 94 

r 

Public health 

89/437, 
92/118. 

91/684, 
96/23 

7 CFR 59 
EPIA 
Law 91-597 

Public 

Permit  required  from  areas 
affected 
Newcastle 
by 
disease. 

to 

U.S. 
requirement. 

review 

permit 

90/539,93/342  Yesl 

U.S. to supply  information  on 
the legal basis for  recognition 
of equivalence. 

7 CFR 59 
EPIA 
Law 91-597 

Public 

89/437,  91/684, 
92/118,  96/23, 
97/38 

U.S.  to  complete  assessment 
of 
health 
EC 
legislation 

public 

Establishments 
accordance  with 
(7), 
and 
relevant 
footnote  (2). 

fulfilling 
provisions 

listed 
footnote 
the 
of 

EC to complete assessment of 
U.S. public health legislation. 

The  following  tests are to be 
in 
conducted,  as  specified 
to  Directive 
Annex  VI 
on  U.S.  egg 
89/437, 
products 
to 
Europe: 

for  dispatch 

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 
methods  such  as: 
NMKL,  AOAC 

recognised 
ISO, 

68 

- Commodity 

i 

- Species 

European Community Exports to the United States 

United States Exports to the European Commumty 

1 

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  P5 39 

Public health 

89/437,91/684 
94/371,96/23 

9 CFR 94 

Yes 2 

Permit  required  from  areas 
Newcastle 
by 
affected 
disease. 

FFDCA, 
FIFRA,  PHSA, 
EPIA 
21 
CFR 
5.10(a)(4)  and 
(a)  (13),  70-82, 
100.135,  110.3-
110.93, 
172.140, 
172.882, 
182.884, 
520,  524, 
558,1240 
40 CFR 180 
7 CFR 56 

178, 
556, 

43. Gelatin  for  human  consumption  and technical use 
Animal  health 

9 CFR 94 

NE 

Public  health 

92/118 

NE 

FFDCA, 
FIFRA, PHSA 
21  CFR  70-82, 
110.3-
109, 
110.93, 
570, 
573-589 

to 

U.S. 
requirement. 

review 

permit 

9 CFR 94 

90/539,93/342  Yesl 

U.S. to review  legal  basis  for 
recognition of  equivalence. 

U.S.  to  complete  assessment 
health 
of 
legislation. 

public 

EC 

89/437,91/684 
94/371,96/23 

EC to complete assessment of j 
U.S. public health legislation 

FFDCA, 
FIFRA,  PHSA, 
EPIA 
21 
CFR 
5.10(a)(4)  and 
(a)  (13),  70-82, 
100.135,  110.3-
110.93, 
172.140, 
172.882, 
182.884, 
520,  524, 
558,1240 
40 CFR 180 
7 CFR 56 

178, 
556, 

NE 

NE 

92/118 

FFDCA, 
FIFRA, PHSA 
21  CFR  70-82, 
110.3-
109, 
110.93, 
570, 
573-589 

| 

' 

I 

69 

Footnote  1 

The  Pathogen  Reduction: Hazard Analysis  and Critical  Control Point (HACCP)  Systems; Final Rule  was published  at 61  Federal  Register  38806-38989  and amends various 
provisions of CFR Parts 304, 310, 320, 327, 381, 416 and 417. 

Provisions on SSOPs and E coli testing applicable. 

( 

The U.S. and the EC shall discuss, well  in advance of their date of implementation, the staged elements in the above rule to determine whether any further special conditions are 
needed. 

Footnote 2  Horizontal Issues, Meat, Meat Products, Game Meat, Poultry Meat, Minced Meat, Meat Preparations, Egg Products 

a) Packaging material 

Packaging material shall be kept in separate rooms that are used exclusively for this purpose and free of dust and vermin. 

Packaging material shall not be stored on the floor. 

Waxed assembled boxes shall not be nested, unless a liner will be added. 

Assembled boxes with liners shall not be nested. 

Boxes shall not be handled by personnel who are handling exposed product. 

Boxes shall be assembled in a sanitary manner, either in a separate room or, if on the cutting room floor, never within 3 metres of exposed product. 

70 

b) Facility  requirements  for  light coloured walls and cove molding 

Walls shall be smooth, durable, impermeable, and of a colour which permits detection  of insanitary  conditions. 

Walls shall have washable  surfaces. 

Walls  and  floor  junctures  shall  be  constructed  and  maintained  so  as  to  assure  that  surfaces  are  clean  and  free  of  contamination.  Establishments  that  do  not  use  cove 
molding  to  provide  a smooth  transition  from  floor  to wall  to  facilitate  cleaning  must  provide  an  equivalent  alternative  means,  such  as sealing  of  cracks  between  walls 
and  floors,  to maintain sanitary conditions. 

c) Medical  certification  by a medical  doctor 

Prior  to  employment,  new  employees  shall  be  examined  by  a  medical  doctor  or  by  another  medically  qualified  person  who  is  sufficiently  trained  to  identify 
communicable  diseases and working under the supervision  of a medical doctor. 

Establishments shall have in place an appropriate program to continuously monitor employee health. 

Pre-employment  examinations  and  ongoing  health  monitoring  shall  be  carried  out  either  by  a medical  doctor  or by  a person  with  appropriate  medical  training.(e.g.  a  ., 
physician's  assistant or a registered nurse). 

All cases of suspected disease shall be referred  to a medical doctor for diagnosis. 

Establishments  shall keep records of medical examinations and shall make those records available to auditors upon  request. 

d) Wooden pallets in exposed product areas 

The use of wooden pallets in areas where there is exposed product shall be phased  out.  In the interim: 

no wooden pallets shall be used within 3 meters of exposed  product; 

pallets shall be clean, structurally  sound, and covered with a sanitary plastic sheet. 

Those establishments which are already using plastic pallets shall continue to do so. 

When wooden  pallets arc used  in coolers or freezers,  all product  present shall be hygienically  packaged  to prevent contact of product with wood. 

71 

e) Separation  of lavatories and work areas 

Toilet  rooms shall be properly ventilated  and shall be separated from exposed product rooms by either a vestibule or a dressing room. 

0  Dry Storage of Non-Food  Material 

Detergents, disinfectants  and similar substances shall be stored  separately  from  food  and  from wrapping and packaging material. 

g) Water Testing 

Water testing shall continue to be carried out in accordance with EC requirements, 

dot note 3 

Fresh  meat, game meat, meat products, minced meat and meat preparations  of red meat species and poultry 

a) Waste water 

All establishments  shall have an efficient  drainage and plumbing  system, and  all drains and gutters shall be properly  installed with traps and vents approved by FSIS, in 
accordance with 9 CFR 381.49 (a), (c) 

b) Separate storage of edible and inedible products 

Condemned  and other inedible meat and offal  shall be removed  in a hygienic manner, and as quickly as possible, from rooms containing edible material. 

c) Separate storage of packaged  and unpackaged  products 

Un packaged  meat may not be stored  in chilling or  freezer  rooms containing packaged meat. 

d) Structural  wood 

Wooden  structures shall be in good condition, impermeable, smooth, durable rot-proof and sealed with a waterproof  coating. 

e) Use of suspended  showers, spravs and hoses 

Meat shall not be contaminated  by splashing. 

They shall  not be used  as a substitute  for handwashing  facilities. 

72 

0  Sterilization  of equipment 

Establishments  shall  provide  sterilization  equipment (batch or local sterilizers) to clean utensils as often  as necessary.  Implements  such as knives or hooks which  come 
into contact  with meat shall be cleaned and sterilized  frequently,  and in any case whenever they have been in contact with contaminated  material or surfaces  such as the 
external surfaces  of hides. Sterilization shall be done with hot (>82°C) water. 

Footnote 4  Additional  Guarantees for Finland and Sweden 

For  trade  from  the  U.S. to  Sweden  and Finland,  the U.S. will  certify  in  accordance  with  Council  Decision  95/409/EC  (Fresh:  Veal,  beef  and pigmeat),  Council  Decision 
95/410/EC  (live  poultry  for slaughter), Council  Decision  95/411/EC (Fresh  poultrymeat), Commission  Decision  95/160/EC  (breeding  poultry  and day old chicks),  Commission 
Decision 95/161/EC (laying hens) and Commission Decision 95/168/EC (table eggs for human  consumption). 

No attestation  is required  for fresh  meat as defined  in 72/462/EEC destined for manufacturing  into meat products within  Sweden/Finland. 

Footnote  5 

Fresh  meat,  game  meat,  meat  products,  minced  meat,  meat  preparations 

a) Accommodation  for sick and suspect  animals 

Wood shall not be used for pens for sick and suspect animals. 

Sick and suspect  animals shall not be allowed to come into contact with animals intended for slaughter for export to the Community. 

Pens  for sick and suspect  animals  shall be sited and constructed  to preclude  contact  with  animals  intended for slaughter  for export to the Community  and effluent  from 
such pens shall not flow  into adjoining pens or passageways. 

b) Veterinary  supervision  of ante-mortem  inspection 

All cattle  intended for slaughter for export to the EC shall be inspected by an official  FSIS veterinarian,  except: 

feedlot  animals  inspected at the feedlot by a USDA accredited  veterinarian; and 

other fattening  animals under the age of 30 months inspected at the holding by a USDA accredited  veterinarian; 

which shall be inspected by an official  FSIS inspector with appropriate training, knowledge, skills and abilities to carry out this  function. 

73 

All pigs  intended  for  slaughter for export to the EC shall be inspected by an official  FSIS veterinarian, except for market hogs (animals up to  1 year of age), which shall 
be inspected  by an official  FSIS inspector with appropriate training, knowledge, skills and abilities to carry out this function. 

All animals demonstrating abnormal signs shall be diagnosed and disposed of by an official  FSIS veterinarian. 

' 

c) Trichina  testing 

Establishments  shall test horsemeat for trichinae. 

Pigmeat  shall be tested or subjected to cold treatment in accordance with 9CFR 318.10. 

d) Opening of stomachs and  intestines 

There  must  be  a separate  room  for emptying  and cleaning  stomachs  and intestines, unless the processing  is done by closed-circuit  mechanical  equipment which avoids 
contamination  and eliminates odours. 

e) Pig Hearts Incision 

For market  hogs (animals up to  1 year old) which  are destined or from which some part is destined for the EC a statistically  representative  sample, both in numbers or 
percentage  and geographical origin, of hearts shall be incised and their interior surfaces inspected by FSIS personnel, with the results being recorded. 

The U.S. shall  inform  the EC of the sampling methodology, level of confidence,  and programme they intend to use for the sampling referred to above. 

Hearts of all sows and boars  (animals over  1  year of age) which are destined or from which some part is destined for the EC shall be incised and their interior surfaces 
inspected by FSIS personnel, with the results being recorded. 

f) Batch  condemnation 

If carcases, offals  and blood are not correlated at the final post-mortem  inspection point, a batch system shall be operated  in such a way that FSIS can demonstrate that if 
a carcass  is condemned  its offal  and blood shall also be condemned. 

74 

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. 

2. 

3. 

4 

5. 

6. 

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. 

The QA shall include an  establishment monitoring schedule and a log to document both monitoring actions and corrective actions. 

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. 

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. 

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. 

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 

P o u l t r y m e at 

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 

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*. 

The importing Party may carry out verification  procedures, including inspection  of the establishments, to ensure that the relevant requirements are being met. 

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. 

2. 

.3. 

'  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. 

* 

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. 

i 

76 

Footnote  8 

Bison  and  Water  Buffalo 

For exports to the U.S. bison and water buffalo are considered as game  meat. 
For exports to the EC bison and water buffalo  are considered as fresh meat. 

Footnote  9  Non-Comminglemcnt - Meat, Meat Products, Game Meat, Poultry Meat, Minced Meat, Meat Preparations 

Establishments  which  slaughter  both animals whose meat is eligible  for export and animals whose meat is not eligible  for export to one of the Parties, or handle such meat,  shall 
comply with the following conditions: 

1. 

2. 

3. 

4. 

5. 

Animals from  which the meat is intended for export shall be kept separate from those which are not of the same status while at the slaughter establishment. 

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. 

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. 

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. 

Records of the origin of the animals from which the meat is produced shall be retained for a period of 6 months after export. They shall be available for inspection by the 
Regulatory Authority. 

6. 

Compliance with the above conditions shall be certified by an official  veterinarian. 

Footnote  10  Milk and  Milk Products not for human  consumption 

Excludes products regulated as animal drugs in the U.S. 

. 

' 

Footnote  11  Residue  Testing 

Residue testing shall continue to be carried out by the U.S. in accordance with applicable EC requirements. 

77 

ANNEX VI 

GUIDELINES FOR CONDUCTING AN AUDIT 

Where standards, guidelines, or recommendations pertaining to the conduct of audits are adopted  by one of 

the relevant international standard-setting organisations, the Parties will review the contents of this Annex, and 

make any appropriate modifications. 

GENERAL PROVISIONS 

1. 

Definitions 

The following definitions shall apply to terms used in this annex: 

1.1. 

audit - assessment of performance. 

1.2. 

auditee - the exporting Party whose enforcement and control programme is the subject of the audit. 

1.3. 

auditor - the importing Party that conducts the audit. 

1.4. 

establishment - processing plant for animals or animal products. 

1.5. 

facility  - site other than  a processing plants where animals or animal  products  might  be handled, 

excluding retail premises. 

2. 

general Principles 

2.1. 

The  auditor  and  the  auditee  should  co-operate  in  carrying  out  audits  in  accordance  with  the 

provisions set out in this Annex. The audit team should include representatives of both the auditor 

and the auditee, and the auditee should  designate personnel responsible  for  facilitating  the  audit. 

Specialised  professional  skills  may  be  necessary  to  carry  out  audits  of  specialised  systems  and 

programmes. 

2.2. 

Audits  should  be  designed  to  check  the  effectiveness  of  the  auditee's  enforcement  and  control 

programme rather than to reject individual animals, consignments of food or establishments. 

2.3. 

The auditee must operate a documented programme to demonstrate to the auditor that standards are 

being met on a consistent basis. 

2.4. 

The frequency of audits should be based on the performance of the exporting Party in carrying out its 

enforcement  and  control  programme.  A  low  level  of  performance  should  result  in  an  increased 

frequency of audit, for example to ensure that unsatisfactory performance has been corrected. 

2.5. 

Audits, and the decisions based on them, should be made in a transparent and consistent manner. 

78 

PROCEDURES 

3. 

Preparation of the Audit Plan 

In consultation with the auditee, the auditor should prepare an audit plan that covers the following points: 

3.1. 

the subject, depth and scope of the audit; 

3.2. 

the date and place of the audit, and the types of any establishments or facilities to be visited so that 

appropriate audit team members may be chosen; 

3.3. 

a timetable up to and including the presentation of the final report; 

3.4. 

the language or languages in which the audit will be conducted and the report written; 

3.5. 

the identity of the members of the audit team,  including the leader; 

3.6. 

a schedule of meetings with officials  and visits to establishments or facilities, including unannounced 

visits, as appropriate; and 

3.7. 

provisions for respect of commercial confidentiality  and avoidance of conflicts of interest. 

4. 

Opening  Meeting 

An opening  meeting  should  be held between  representatives  of both Parties.  At this meeting the auditor will' 

review  the audit plan  and confirm  that adequate resources  and documentation  are available and all  necessary 

arrangements have been made for conducting the audit. 

5. 

Document  Review 

5.1. 

The document review may include, for example, the  following: 

* 

* 

* 

* 

* 

* 

* 

records concerning compliance programmes; 

inspection and internal audit reports; 

documentation concerning corrective actions and sanctions; 

records of compliance actions taken; 

sampling plans and their results; 

documents associated with verification;  and 

regulatory procedures followed  by the auditee. 

5.2. 

In  the  case  of  an  audit  that  is  subsequent  to  a  determination  of  equivalence,  the  document  review 

may also consist  of a review of relevant changes to the  inspection  and  certification  systems since the 

determination  of equivalence or since the previous audit. 

5.3. 

The  audilec will co-operate  fully  with  the auditor  in the document  review  process and  help  to ensure 

that  the auditor has access to requested  documents and records. 

79 

6. 

On-site Verification 

6.1. 

The  decision  to  conduct  on-site  verification  should  take  into  account  factors  such  as  the  risks 

associated  with  the  animals  or  animal  products  concerned,  the  history  of  conformity  with 

requirements  by  the  industry  sector  or  exporting  country,  the  volume  of  product  produced  and 

imported  or exported,  changes  in  infrastructure  and the  nature  of  the  inspection  and  certification 

systems. 

6.2. 

On-site  verification  may  involve  visits  to  production  and  manufacturing  establishments,  facilities, 

food  handling  or  storage  areas  and control  laboratories  to  check  the  accuracy  of  the  information 

contained in the documentary material referred to in 5.1. 

6.3. 

When checks of establishments or facilities are carried out, the auditee will carry out the check of the 

establishment  or  facility,  following  the  auditee's  usual  procedures,  and  the  auditor  will  generally 

participate as an observer, though is free to check other aspects of performance if deemed necessary. 

6.4. 

The auditee will co-operate fully with the auditor in the on-site verification  process and facilitate the 

auditor's entry into the establishments and facilities that are the subject of the on-site verification. 

7. 

Follow-up Audit 

A follow-up audit may be conducted to verify the correction of deficiencies  identified  in a prior audit. 

8. 

Working Documents 

Working documents may  include checklists of elements to evaluate, such as the following: 

* 

* 

* 

* 

* 

* 

* 

legislation; 

structure and operations of inspection and certification services; 

establishment and facility structure, layout, operations and working procedures; 

health statistics, sampling plans and results; 

compliance action and procedures; 

reporting and complaint procedures; and 

training programmes. 

9. 

Closing  Meeting 

A closing  meeting shall  be held  between  representatives  of both  Parties, including officials  responsible  for  the 

inspection  and certification  programmes of the auditee.  At this meeting the auditor  will present  the findings  of 

the audit. The  information  should  be presented  in a clear, concise  manner  so that  the  conclusions  of  the  audit 

arc clearly  understood. 

80 

10. 

Audit  Report 

The auditor shall provide the auditee with a draft  report of the audit generally within 60 days of the conclusion 

of the audit. To the extent possible, the report shall be presented  in a standardised  format to be agreed upon  by 

the  Parties  in  order  to  make  the  approach  to  audit  more uniform,  transparent  and  efficient.  The  report  will 

assess the adequacy of the auditee's enforcement  and control programme  and  identify  any deficiencies  noted 

during the conduct of the audit. Thereafter,  the auditee may within  60 days comment on the draft  report  and 

shall describe  any  specific  corrective  actions that  will  be taken,  preferably  with  target  dates  for  completion. 

Any comments made by the auditee shall be included in the final report. 

ANNEX VII 

FRONTIER CHECKS 

The  Parties  recognise  the  distinction  between  documentary,  identity  and  physical  checks  carried  out  at 

external frontiers on imports of live animals and animal products. 

The Parties further recognise the need to take a systematic approach to carrying out frontier checks. 

Both Parties agree that charges may be made for these checks, in conformity with the relevant provisions of 

Annex C to the SPS Agreement. 

Live Animals 

The Parties may apply physical checks to all consignments of live animals. 

Animal Products 

In  setting  their  physical  checking frequencies for  imports  of  animal  products,  the  Parties  shall  take  due 

account of the checks applied by the exporting Party prior to export and the historic performance  of products 

imported from the exporting Party. 

The Parties may modulate the;r physical checking frequencies for imports of animal products, notably in the 

light of progress made toward the recognition of equivalence under the consultative process provided  for in 

Article 7. 

82 

ANNEX VIII 

OUTSTANDING ISSUES 

The  Parties  agree to work  to  further  develop  agreed  arrangements  concerning  frontier  checks, 

including the frequency of physical checks. 

The Parties agree to work  together on their respective arrangements  concerning  feed  additives, 

animal feedingstuffs,  medicated feeds and premixes. 

83 

ANNEX IX 

CONTACT POINTS 

The  U.S.  will  send  the  information  provided  for  in  Article  10,  and  carry  out  the  notifications 

provided for in Article  11, to: 

Agricultural Counsellor 

European Union 

Delegation of the European Commission to the United States 

2300 M Street NW 

Washington DC 20037 

phone:  1  202 862 9560 

fax: 

1202 429  1766 

The Community will send the information  provided for in Article  10, and carry out the  notifications 

provided for in Article  11, to: 

Agricultural Attaché 

Office  of Agricultural  Affairs 

U.S. Mission of the European Union 

40 Blvd du Regent 

1000 Brussels, Belgium 

phone:  32 2 508 2760 

fax: 

32 2 5110918 

84 

ISSN 0254-1475 

COM(97) 566  final 

DOCUMENTS 

EN 

11  03  02  05 

Catalogue  number  :  CB-CO-97-615-EN-C 

ISBN  92-78-27561-1 

Office  for  Official  Publications of the European  Communities 

L-2985  Luxembourg