Agreement between the European Community and the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal products
Date: 1999-07-20
Institutions: European Community, United States
Subjects: United States, animal product, live animal, public health, trade agreement (EU), veterinary inspection

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AGREEMENT

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

THE  EUROPEAN  COMMUNITY,

of  the  one  part,  and

THE  GOVERNMENT  OF  THE  UNITED  STATES  OF  AMERICA,

of  the  other  part,

DESIRING  to  safeguard  public  and  animal  health  and  to  facilitate  trade  in  animals  and  animal  products
between  the  European  Community  (hereinafter  referred  to  as  ‘the  Community’)  and  the  United  States  of
America  (hereinafter  referred  to  as  ‘the  USA’);

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  utilisation  of  inspection  and  verification  resources;

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

THE  EUROPEAN  COMMUNITY

THE  GOVERNMENT  OF  THE  UNITED  STATES  OF  AMERICA

WHO  HAVE  AGREED  AS  FOLLOWS:

Article  1

Objective

establishing  the  World  Trade  Organisation  and 
Annexes,  in  particular  the  SPS  Agreement.

its

The  objective  of  this  Agreement  is  to  facilitate  trade  in
live  animals  and  animal  products  between 
the
Community  and  the  USA  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
the  Agreement
the  Parties  under 
obligations  of 

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

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residues),  chemicals  originating  from  the  migration  of
substances 
labelling  of
from  packaging  materials; 
foodstuffs (including nutritional labelling); feed additives,
animal  feedingstuffs,  medicated  feeds  and  premixes.

The  Parties  may  agree  to  modify  this  Agreement  in
3.
the  future  to  extend  the  scope  to  other  sanitary  or
phytosanitary  measures  affecting  trade  between  the
Parties.

Article  4

Regulatory  authorities

1.
The  USA:  regulatory  authority  for  imports  and
exports  of  live  animals  and  animal  products  is  as
described  in  part  A  of  Annex  II.

The  Community:  control  in  veterinary  affairs  is  as

2.
described  in  part  B  of  Annex  II.

Article  5

Definitions

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

(a)

(b)

(c)

‘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;

‘appropriate  level  of  sanitary  protection’  means  the
appropriate level of sanitary protection as defined in
Annex  A,  paragraph  5,  of  the  SPS  Agreement;

‘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
1.
health  status  of  regions,  as  determined  by  the  exporting
Party,  with  respect  to  the  animal  and  aquaculture
diseases  specified  in  Annex  III.

The  importing  Party  shall  recognise  regionalisation
2.
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 an 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
1.
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 
standards,
procedures, policies, infrastructure, enforcement
and  control;

regulations 

regarding 

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(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
its  enforcement  and  control

efficacy  of 
programmes.

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  on  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

1.
Annex  V  lists  the  live  animals  and  animal  product
areas,  sectors,  or  parts  of  sectors,  and,  for  each  area,
sector  or  part 
the  status  of
consultations  regarding  the  recognition  of  equivalency  of
a  Party’s  sanitary  measures  and  the  applicable  trade
conditions.

thereof,  sets 

forth 

2.

(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  three
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.

special  conditions 

(b) Where  the  trade  conditions  specified  in  Annex  V
include 
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.

required  by 

The Parties shall carry out the respective actions set
3.
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.

frontier, 

In addition to carrying out checks on imports at the
2.
external 
importing  Party  may  verify
compliance  with  the  provisions  of  this  Agreement
through the application of procedures which may include,
but  are  not  limited  to:

the 

(a) an  assessment  of  all  or  part  of  the  exporting  Party’s
including,  where
programme, 
the  exporting  Party’s

total 
appropriate, 
inspection  and  audit  programmes,  and

reviews  of 

control 

(b) on-site  checks  and  inspections.

3.
The  Community  will  carry  out  the  verification
procedures provided for in paragraph 2. The US agencies
identified  in  Annex  II  shall  facilitate  the  performance  of
these  verification  procedures  by  the  Community.

The  US  agencies  identified  in  Annex  II  will  carry
4.
in
the  verification  procedures  provided 
out 
paragraph  2.  The  Community  shall 
the
performance  of  these  verification  procedures  by  those
agencies.

for 
facilitate 

5. On  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 

the  verification
shall  carry  out 
6.
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.

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Article  10

Information  exchange

The  Parties  shall  exchange 

information  on  a
1.
uniform and systematic basis to improve communication,
to  engender  mutual  confidence,  and  to  demonstrate  the
efficacy  of 
controlled.  Where
appropriate,  this  may  be  supported  by  exchanges  of
officials  between  the  Parties.

the  programmes 

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,  or  to  change  existing  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  other  Party.

The Parties agree to establish an appropriate means
5.
import
exchanging 
of 
consignments,  relevant 
information,
and  other  problem  areas  concerning  public  or  animal
health.

inspection-related 

information  on 

rejected 

The  contact  points  for  this  information  exchange

6.
are  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 
consumption  of  animal
products;

the 

(b) within  24  hours  in  writing:  of  the  presence  or

evolution  of  any  disease  listed  in  Annex  III;

(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.

Such  notifications  shall  be  made  to  the  contact

2.
points  set  out  in  Annex  IX.

3. Where either Party has serious concerns regarding a
risk  to  public  or  animal  health,  consultations  regarding
the  situation  shall,  on  request,  take  place  as  soon  as
possible, and in any case within 14 days. Each party shall
endeavour 
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.

in  such  situations 

to  provide  all 

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 
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.

issues 

listed 

Article  14

Joint  Management  Committee

‘the  Committee’), 

Joint  Management  Committee 
to  as 

(hereinafter
1.
A 
referred 
consisting  of
representatives of the USA 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

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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
USA  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.

Article  15

Territorial application

This  Agreement  shall  apply,  on  the  one  hand,  to  the
territories  in  which  the  Treaty  establishing  the  European
Community  is  applied  and  under  the  conditions  laid
down  in  that  Treaty,  and  on  the  other  hand,  to  the
its  entire
United  States  of  America 
territory.

in  respect  of 

Article  16

Final  provisions

This  Agreement  shall  be  approved  by  the  Parties  in

1.
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  subparagraph  have  been  completed.

Each  Party  shall  implement  the  commitments  and
2.
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,  on  six  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
European  Community

For  the  Government  of  the
United  States  of  America

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Annexes

ANNEX  I

Product  coverage

ANNEX  II

Regulatory  authorities

ANNEX  III

List  of  diseases  for  which  regional  freedom  is  recognised

ANNEX  IV

Zoning  and  regionalisation

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

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ANNEX  I

PRODUCT  COVERAGE

Tariff  line

General  description (1)

01

02

03

04

05

1501

1502

1503

1504

1505

1506

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-oil  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

1516 10

Animal  fats  and  oils  and  their  fractions

1517

1518

1522

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  mixtures  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

16

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

1702 10

Lactose  and  lactose  syrup

1901

1902

2104

2105

2106

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; homogenised 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

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Tariff  line

2301

2309

3001

3002

3101

3501

3502

3503

3504

3507

4101

4102

4103

4301

5101

5102

5103

5105

9705

General  description (1)

Flours,  meals  and  pellets,  of  meat  or  meat  offal,  of  fish  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

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

Raw  hides  and  skins  of  bovine  or  equine  animals

Raw  skins  of  sheep  or  lambs

Other  raw  hides  or  skins

Raw  furskins

Wool

Fine  or  coarse  animal  hair

Waste  of  wool  or  of  fine  or  coarse  animal  hair

Wool  and  fine  or  coarse  animal  hair

Collections  and  collectors’  pieces  of  zoological  interest

(1) For  definitive  description  refer  to  tariff  code.

21.4.98

EN

Official  Journal  of  the  European  Communities

L 118/11

ANNEX  II

REGULATORY  AUTHORITIES

A. UNITED  STATES  OF  AMERICA

I. USA  CONTROL  AUTHORITY

The federal agencies listed in this section are responsible for both domestically-produced and imported
animal  products,  unless  otherwise  noted.

In  relation  to  imports  into  the  USA,  these  agencies  are  responsible  for:

— conducting  frontier  checks  provided  for  in  the  Agreement,

— carrying  out  the  consultations  provided  for  pursuant  to  Article  7  of  the  Agreement,

— carrying  out  the  verification  procedures  provided  for  in  Article  9  of  the  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.

In  relation  to  exports  from  the  USA,  unless  otherwise  noted,  these  agencies  are  responsible  for:

— controlling  the  circumstances  of  domestic  production  and  processing,

— providing  information  concerning  compliance  with  agreed  regulatory  requirements,

— providing  agreed  additional  guarantees,

— carrying  out  the  consultations  provided  for  pursuant  to  Article  7  of  this  Agreement,

— carrying  out  the  information  exchange  provided  for  in  Article  10,  the  notifications  provided  for  in

Article  11,  and  the  safeguards  provided  for  in  Article  12  of  the  Agreement.

A. Control  of  animal  health

1. Animal  diseases/pests

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

(b)

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

(c)

Imports  of  uneviscerated  salmonid  fish  —  DOI/FWS.

(d) Animal  feed  (including  pet  foods)

1. Transmission  of  disease  from  feed  —  USDA/APHIS.

2. Adulteration,  pesticides,  chemical  and  microbial  contamination,  food  additives,
substances  ‘generally  recognised  as  safe’  —  Food  and  Drug  Administration  (FDA).

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  —  US  Department  of  Agriculture/Food  Safety  and  Inspection  Service
(USDA/FSIS) (1).

(b) Fresh  meat  and  products  from  domestic  and  farmed  chickens,  turkeys,  ducks,  geese,  and

guinea  fowl  —  USDA/FSIS (2).

(1) With  very  limited  exceptions,  the  USDA/FSIS  has  sole  jurisdiction  for  these  foods  until  the  time  they  leave  the
slaughterhouse.  After  the  meat  and  products  have  left  the  slaughterhouse,  the  USDA/FSIS  and  the  FDA  share
jurisdiction.  The  FDA  is  responsible  for  the  approval  of  veterinary  drugs  and  food  additives  in  meat  and  poultry.

(2) See  preceding  footnote.

L 118/12

EN

Official  Journal  of  the  European  Communities

21.4.98

(c) Fresh  meat  and  products  from  wild  and  farmed  game,  with  the  exception  of  those  from

IB1(a)  and  IB1(b)  above  —  (FDA).

(d) Fresh  meat  and  products  from  species  other  than  above  —  FDA.

(e) Enforcing  adulteration  provisions  of  the  law  and  limits  for  residues  of  drugs,  pesticides,

heavy  metals,  mycotoxins,  and  other  contaminants  in  food:

1.

sampling of fresh meat and animal products and control of the fresh meat and products
from  domesticated,  farmed  and  wild  cattle,  sheep,  swine,  goats,  and  equine,  and  for
domesticated  and  farmed  chickens  (including  liquid,  frozen  and  dried  egg  products),
turkeys,  ducks,  geese,  and  guinea  fowl  —  USDA/FSIS;

2.

sampling of fresh meat and animal products (including animal feed) and control of the
fresh  meat  and  products  of  other  species  —  FDA.

2. Eggs  and  egg  products

(a) Shell  eggs,  hard-cooked  eggs,  ethnic  egg  delicacies,  and  imitation  egg  products  —  FDA.

(b) Shell  eggs  (including  cracks  and  dirties)  for  breaking  for  the  production  of  liquid,  frozen,
and  dried  egg  products  (egg  yolks,  albumen,  or  any  combination)  —  USDA/FSIS (1).

3. Dairy

(a) All  dairy  products  —  FDA.

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  PROGRAMMES

The  federal  agencies  listed  in  this  section  are  responsible  for  voluntary  inspection  and  certification
programmes  for  domestically-produced  animal  products.

In  relation  to  exports  from  the  USA,  these  agencies  are  responsible  for:

— oversight  of  the  circumstances  of  domestic  production  and  processing  for  firms  who  participate  in

the  voluntary  programme,

— providing information concerning compliance with agreed requirements for firms who participate in

the  voluntary  programme,

— providing  agreed  additional  guarantees  for  firms  who  participate  in  the  agreed  programme.

A. Animal health

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

2.

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

3. Animal  feed  (including  pet  foods)  containing  fish  and  fishery  products  —  USDA/APHIS,

Commerce/NMFS.

(1) The  FDA  and  FSIS  share  jurisdiction  over  these  products  after  they  have  left  the  processing  plant.

21.4.98

EN

Official  Journal  of  the  European  Communities

L 118/13

B. Public  health

1. Fresh meat and meat products (1) from wild and farmed bison, ostrich, emu, rhea, rabbit, deer,

partridge,  and  quail  —  USDA/FSIS.

2. Snakes  for  human  consumption  —  Commerce/NMFS.

3. Shell  eggs  —  USDA/AMS.

4. Cooked  omelets  made  from  egg  products,  diced  eggs  made  from  egg  products  —  USDA/FSIS.

5. Dairy — USDA/AMS.

6. Seafood  (including  live  seafood)  —  Commerce/NMFS.

III. FEDERAL  AGENCIES  THAT  ISSUE  CERTIFICATION

This  section  lists  the  USA  national  agencies  that  issue  export  certificates  agreed  to  by  the  EC  and  the
USA (2). 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

FDA

USDA/
AMS

USDA/
APHIS

USDA/
FSIS

A. Animal  health  certifications

1. Live  animals 

(including  apiculture  bees),
embryos,  ova,  semen,  and  products  of  animal
origin

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

3. Salmonid  live  fish,  gametes,  and  fertilised  ova

4. Wild  waterfowl

5. Animal feed

B. Public  health  certifications

1. Meat  and  poultry  for  human  consumption

and 

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

farmed 

(b) Snakes

(c) Fresh  meat  and  products  from  species

other  than  above

×

×

×

×

×

×

×

×

×

×

×

×

×

×

(1) These  meat  products  must  be  made  from  fresh  meat  slaughtered  under  the  USDA/FSIS  voluntary  programme.
(2) 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.

L 118/14

EN

Official  Journal  of  the  European  Communities

21.4.98

DOC/
NMFS

DOI/
FWS

FDA

USDA/
AMS

USDA/
APHIS

USDA/
FSIS

2. Eggs

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

×

×

(b) Liquid,  frozen  and  dried  egg  products

×

3. Dairy

(a) Butter,  cheese,  frozen  desserts,  and  dried

milk  products

(b) Fluid  milk

4. Seafood

(a) Fish and fishery products including fish oil,
and

snakes), 

(except 

snails 

reptiles 
amphibians

×

(b) Live  fish  (including  shellfish  and  molluscs)

×

×

×

×

×

×

B. EUROPEAN  COMMUNITY

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

— in  terms  of  exports  to  the  USA,  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  coordination,  inspections/audits  of  inspection
systems  and  the  necessary  legislative  action  to  ensure  uniform  application  of  standards  and
requirements  within  the  Single  European  Market.

21.4.98

EN

Official  Journal  of  the  European  Communities

L 118/15

ANNEX  III

LIST  OF  DISEASES  FOR  WHICH  REGIONAL  FREEDOM  IS  RECOGNISED

Animal  diseases

Foot  and  mouth  disease

Swine  vesicular  disease

Peste  de  petits  ruminants

Contagious  caprine  pleuropneumonia

Sheep  and  goat  pox

African  swine  fever

Enterovirus encephalomyelitis

Newcastle disease

Pseudorabies/Aujeszky’s disease

Vesicular  stomatitis

Rinderpest

Contagious  bovine  pleuropneumonia

Bluetongue

African  horse  sickness

Classical  swine  fever

Fowl  plague  (avian  influenza)

Venezuelan  equine  encephalomyelitis

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.

Aquaculture  diseases

L 118/16

EN

Official  Journal  of  the  European  Communities

21.4.98

ANNEX  IV

ZONING  AND  REGIONALISATION

The  Parties  have  jointly  determined  that  the  following  forms  the  basis  for  regionalisation  decisions  for  the
diseases  listed  in  accordance  with  Annex  III.  Each  Party  will  recognise  regionalisation  decisions  taken  in
accordance  with  the  standard  contained  within  this  Annex.

Animal  diseases

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

1. Source  risk  factors

2. Commodity  risk  factors

3. Destination  risk  factors

Source  risk  factors

The primary determinant of the risk of importing disease is the status of the country of origin in respect of
the  disease  in  question.  However,  declarations  of  disease  freedom  must  be  backed  up  by  effective
surveillance programmes.

The  overriding  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  that  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.

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.

21.4.98

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L 118/17

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,  for  example,  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,
for  example  by  additional  guarantees,  testing  or  treatment.

Unknown  risk  implies  that  importation  will  only  take  place  if  the  commodity  itself  is  of  very  low  risk,  for
example  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,  for  example  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,  for  example  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,

— preventive  measures  such  as  waste  food  feeding  and  animal  waste  rendering  rules,

— intended  use  of  product  for  example  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,  for  example
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
regionalisation  decisions  for  aquaculture  diseases  will  be  the  International  Aquatic  Animal  Health  Code  of
the  OIE.

L 118/18

EN

Official  Journal  of  the  European  Communities

21.4.98

ANNEX  V

RECOGNITION  OF  SANITARY  MEASURES

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

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

CEM

Contagious  equine  metritis

CFR

Code  of  Federal  Regulations

CSF

EBL

EC

Classical  swine  fever  (hog  cholera)

Enzootic  bovine  leucosis

European  Community

EPIA

Egg  Products  Inspection  Act

FFDCA Federal  Food,  Drug  and  Cosmetics  Act

FIFRA

Federal  Insecticide,  Fungicide  and  Rodenticide  Act

FMD

Food  and  mouth  disease

IBR

ND

OIE

Infectious  bovine  rhinotracheitis

Newcastle disease

Office  International  des  Epizooties

PHSA

Public  Health  Service  Act

PM

Post  mortem

ScVC

Scientific  Veterinary  Committee

SVD

Swine  vesicular  disease

TB

Bovine  tuberculosis

TME

Transmissible  mink  encephalopathy

TSE

USA

Transmissible  spongiform  encephalopathy

United  States  of  America

WTO

World  Trade  Organisation

— Commodity

— Species

— Animal/public health

1. Live animals

Animal health

— Equidae

European  Community  exports  to  the  United  States

United  States  exports  to  the  European  Community

Trade  conditions

EC
standards

US
standards

Equiv.
(Cat.)

Special conditions

Actions

Trade  conditions

US
standards

EC
standards

Equiv.
(Cat.)

Special  conditions

Actions

9 CFR 71,
75,  91

E

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

US  to  consider  identifying
horses  by  passport  from
31.12.1997.

EC  to  consider
withdrawing  requirement
for  isolation  before
departure  for  permanent
imports  within  six
months  of  the  submission
of  the  final  report  on  VS
outbreak.

9 CFR 92

E

90/426
Annexes  B
and  C

EC  to  submit  for  each
EC  laboratory  the
testing  procedures,
antigens/reagents used,
audit/quality  control
programme,  external
control/laboratory
approval programme.
Inter-laboratory
reference  testing  and
exchange  of  samples
between  designated  EC
and  US  laboratories  for
CEM,  glanders,  dourine,
piroplasmosis, equine
infectious  anaemia  and
equine  viral  arteritis  to
be  carried  out  within
three  months  of  the
entry  into  force  of  this
Agreement.

US  to  consider,  within
five  months  of  the  entry
into  force  of  this
Agreement, withdrawing
requirement  for
post-import  quarantine
on  the  bases  of  results.

US  to  assess  EC  request
on  disease  status  for
dourine  and  glanders
within  three  months  of
EC  submission.

.

2
1
4
9
8

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L
1
1
8

/

1
9

 
 
 
 
 
European  Community  exports  to  the  United  States

United  States  exports  to  the  European  Community

Special conditions

Actions

Trade  conditions

US
standards

EC
standards

Equiv.
(Cat.)

Special  conditions

Actions

— Commodity

— Species

— Animal/public health

Trade  conditions

EC
standards

US
standards

Equiv.
(Cat.)

1. Live  animals  —  animal  health  (cont’d)

— Equidae
(cont’d)

— Bovine animals

9 CFR 92

E

64/432
72/462
90/425

US  to  review  their  CEM
and  piroplasmosis
requirements  within
three  months  of  the
entry  into  force  of  this
Agreement.

US  to  review  BSE  policy
with  respect  to  high  and
low incidence.

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

72/462

E

US  to  produce  generic
conditions  for  EC.

— Sheep/goats

91/68

9 CFR 92

E

US  to  produce  generic
conditions  for  EC.

9 CFR 54,
71,  79,  77

91/68
97/231

E

— Swine

9 CFR 92

E

64/432
72/462
90/425

US  to  produce  generic
conditions  for  EC.

72/462

E

9 CFR 71,
76,  77,
78,  85

— Dogs  and  cats

92/65

9 CFR 92 NE

— ‘Balai’ animals

92/65

9 CFR 92 NE

92/65

NE

92/65

NE

L
1
1
8

/

2
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

2
1
4
9
8

.

EC  to  review  US  dossier
on  bluetongue.

US  to  provide  details  of
RB51  brucellosis  vaccine,
for  review  by  EC.

EC  to  produce  conditions
for  US.

EC  to  review  US  dossier
on  bluetongue.

US  to  submit  scrapie
programme  when  final
review  is  completed.  EC
to  comment.

EC  to  produce  conditions
for  US.

EC  to  produce  conditions
for  US.

 
 
 
 
 
2. Live  poultry  and  hatching  eggs

90/539
93/342

9 CFR 92

E

US  to  produce  generic
conditions.

9 CFR 71,
82,  145,
147

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

E

Animal health

3. Semen

Animal health

— Bovine

88/407

9 CFR 98

E

US  to  produce  generic
conditions  for  EC.

9 CFR 71,
77,  78

88/407
94/577

E

— Sheep/goats

92/65

9 CFR 98

E

US  to  produce  generic
conditions  for  EC.

9 CFR 71,
79

Directive
92/65

NE

— Porcine

90/429

9 CFR 98

E

US  to  produce  generic
conditions  for  EC.

9 CFR 71,
78,  85

90/429
93/199

E

— Canine

92/65

9 CFR 98 NE

— Feline

92/65

NE

92/65

NE

92/65

NE

.

2
1
4
9
8

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L
1
1
8

/

2
1

EC  to  produce  conditions
to  allow  use  of  new  elisa
test  kit  for  bluetongue.

EC  to  consider  allowing
movement  between
centres  in  two  approved
third  countries.

EC  to  examine  US
request  that  CSF  tests
not  be  required  on  entry
and  exit  from  centres  in
countries  free  of  the
disease.

 
 
 
 
 
European  Community  exports  to  the  United  States

United  States  exports  to  the  European  Community

— Commodity

— Species

— Animal/public health

Trade  conditions

EC
standards

US
standards

Equiv.
(Cat.)

4. Equine  semen,  ova  and  embryos

Special conditions

Actions

Trade  conditions

US
standards

EC
standards

Equiv.
(Cat.)

Special  conditions

Actions

92/65
95/307

92/65
95/294

92/65
95/294

9 CFR 98 NE

9 CFR 98 NE

9 CFR 98 NE

Animal health

— Semen

— Ova

— Embryos

5. Embryos

Animal health

9 CFR 71,
75

92/65
96/539

9 CFR 71,
75

92/65
96/540

9 CFR 71,
75

92/65
96/540

NE

NE

NE

— Bovine

89/556

9 CFR 98

E

US  to  produce  generic
conditions  for  EC.

9 CFR 71,
77,  78

89/556
92/471

E

US  to  review  suspension
of  imports  from  BSE
affected  countries.

— Ovine/caprine

92/65

9 CFR 98 NE

92/65

NE

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.

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

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

72/462
82/426

Yes 2 Three  month  residence.

Holding  freedom  from
brucellosis  for  ovines
and  caprines.

L
1
1
8

/

2
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

2
1
4
9
8

.

 
 
 
 
 
— Equidae

— Porcine  animals

9 CFR 94 Yes 1

9 CFR 94 Yes 1

64/432
72/461
72/462

64/432
72/461
72/462

9 CFR 53

72/462
82/426

Yes 2 Three  month  residence.

9 CFR 53

72/462
82/426

Yes 2 Three  month  residence.

Holding  freedom  from
brucellosis.

Public  health

Ruminants (8)
Equidae
Porcine
Ovine
Caprine

64/433
96/22
96/23

9  CFR
301—381,
416,  417

Yes 3 Establishments  listed  in
accordance  with
footnote  (7),  and
fulfilling  the  relevant
provisions  of
footnote  (1).

Equivalency (Yes 2)  shall
be  granted  after  the  US
has  completed
verification  of  veterinary
delivery  systems.  This
process  shall  be
completed  within
12  months  of  the  date
of  entry  into  force  of
this  Agreement.

9  CFR
301—381,
416,  417

72/462
93/158
96/22
96/23

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

.

2
1
4
9
8

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L
1
1
8

/

2
3

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

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

The  EC  to  evaluate  a  US
request,  when  submitted,
on  the  need  for
continued  trichinae
testing  of  horsemeat.

 
 
 
 
 
European  Community  exports  to  the  United  States

United  States  exports  to  the  European  Community

Special conditions

Actions

Trade  conditions

US
standards

EC
standards

Equiv.
(Cat.)

Special  conditions

Actions

— Commodity

— Species

— Animal/public health

Trade  conditions

EC
standards

US
standards

Equiv.
(Cat.)

6. Fresh  meat  —  public  health  (cont’d)

Ruminants (8)
Equidae
Porcine
Ovine
Caprine
(cont’d)

7. Poultry  meat

Animal health

Public  health

91/494
94/438

71/118
96/22
96/23

9 CFR 94 Yes 1

9 CFR 381 Yes 3 Establishments  listed  in

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

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

9 CFR 53

9  CFR
381.1—
381.5

91/494
93/342
94/984

71/118
96/22
96/23
96/712

Yes 1

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

L
1
1
8

/

2
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

2
1
4
9
8

.

Regarding  footnote  5(e),
the  results  of  the
inspections  after  incision
of  pig  hearts  shall  be
jointly  evaluated  after
12  months,  with  a  view
to  determining  if
modifications  should  be
made  to  the  provisions  of
footnote  5(e).
Equivalency (Yes 2)  shall
be  granted  after  the  EC
has  completed
verification  of  the
application  of  the
specified  conditions.  This
process  shall  be
completed  within
12  months  of  the  entry
into  force  of  this
Agreement.

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

 
 
 
 
 
The  EC  shall  evaluate  the
US  water  standards  to
determine  whether  they
meet  the  EC  level  of
protection.  This
evaluation  shall  be
completed  within  six
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
US  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  this
Agreement.

8. Meat  products

Animal health

— Red  meat

(ruminants/
equidae)

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

9  CFR  94 Yes 2 Additional  certification

for  bovines  from  BSE
affected  countries.

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

9  CFR  53 72/462
97/221

Yes 2 Derived  from  meat

meeting  the  conditions
of  point  6  (fresh  meat).

.

2
1
4
9
8

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L
1
1
8

/

2
5

 
 
 
 
 
European  Community  exports  to  the  United  States

United  States  exports  to  the  European  Community

— Commodity

— Species

— Animal/public health

Trade  conditions

EC
standards

US
standards

Equiv.
(Cat.)

8. Meat  products  —  animal  health (cont’d)

Special conditions

Actions

Trade  conditions

US
standards

EC
standards

Equiv.
(Cat.)

Special  conditions

Actions

— Pigs

— Poultry

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

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

9  CFR  94 Yes 1

9  CFR  53 72/462
97/221

Yes 2 Derived  from  meat

meeting  the  conditions
of  point  6  (fresh  meat).

9  CFR  94 Yes 1

9  CFR  53 97/221

Yes 2 Derived  from  meat

meeting  the  conditions
of  point  7  (poultry
meat).

— Wild  game  and
farmed  game

92/495
92/45

9  CFR  94 Yes 2 Additional  certification

for  bovines  from  BSE
affected  countries.

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

NE

92/495
92/45
97/221

Public  health

Ruminants (8)
Equidae
Pigs
Poultry

77/99
96/22
96/23

CFR
301—335,
354,
381.1—
381.500

Yes 3 Establishments  listed  in
accordance  with
footnote  (7),  and
fulfilling  the  relevant
provisions  of  footnote
(1).

9  CFR
301—335,
354,
381.1—
381.500

72/462
77/99
92/118
96/22
96/23

Equivalency (Yes 2)  shall
be  granted  after  the  US
has  completed
verification  of  veterinary
delivery  systems.  This
process  shall  be
completed  within  12
months  of  the  date  of
entry  into  force  of  this
Agreement.

Yes 3 Derived  from  meat

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

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

L
1
1
8

/

2
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

2
1
4
9
8

.

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

Equivalency  shall  be
granted  after  the  EC  has
completed  verification  of
the  application  of  the
specified  conditions.  This
process  shall  be
completed  within  12
months  of  the  entry  into
force  of  this  Agreement.

Wild game (8)

Farmed  game (8)

77/99
96/22
96/23

NE

Existing  trade
conditions.

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

NE

77/99
92/118
96/22
96/23

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

9. Farmed  game  meat

Animal health

— Deer

— Rabbit

— Porcine

72/461
92/118
91/495

72/461
92/118
91/495

9  CFR  94 Yes 2

Yes 1

Additional  certification
from  BSE  affected
countries.

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

9  CFR  94 Yes 1

NE

92/118
91/495
97/219

92/118

NE

.

2
1
4
9
8

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L
1
1
8

/

2
7

 
 
 
 
 
European  Community  exports  to  the  United  States

United  States  exports  to  the  European  Community

— Commodity

— Species

— Animal/public health

Trade  conditions

EC
standards

US
standards

Equiv.
(Cat.)

9. Farmed  game  meat  —  Animal  health  (cont’d)

Special conditions

Actions

Trade  conditions

US
standards

EC
standards

Equiv.
(Cat.)

Special  conditions

Actions

9  CFR  94 Yes 1

9  CFR  94 92/118
97/219

NE

— Feathered

Public  health

See  footnote  (8)  for
ruminants

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

91/495
96/22
96/23
97/219

NE

Existing  trade
conditions.

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

10. Wild  game  meat

Animal health

— Deer

— Rabbit

92/45

9  CFR  94 E

— Porcine

92/45

9  CFR  94 E

— Feathered

92/45

9  CFR  94 E

NE

91/495
96/22
96/23
97/219

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

92/45
97/218

92/45
97/220

92/45
97/218

NE

NE

NE

L
1
1
8

/

2
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

2
1
4
9
8

.

 
 
 
 
 
Public  health

See  footnote  (8)  for
ruminants

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

NE

Existing  trade
conditions.

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

11. Fisheries  products  for  human  consumption

USDI  &
Title  50

USDI  &
Title  50

NE

NE

Animal health

— Fish/fisheries  products 91/67

— Bivalve

91/67

molluscs/
crustaceans
(excl. live)

Public  health

— Fish/fisheries  products 91/493

96/22
96/23

NE

92/45
96/22
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

USDI  &
Title  50

USDI  &
Title  50

91/67

NE

91/67

NE

Yes 3 Low-acid  canned  food

requirement.

21  CFR
123,
1240
FFDCA,
FIFRA,
PHSA,
21  CFR
70—82,
180,
110.3—
110.93,
113,  114,
123,
172—193,
1240

Yes 3 95/328

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

US  to  provide  a  detailed
indication  of  how  the
EC  request  for
equivalence  for  low-acid
canned  food  can  be
considered.

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

21  CFR
123,
1240
FFDCA,
FIFRA,
PHSA,
21  CFR
70—82,
180,
110.3—
110.93,
113,  114,
123,
172—193,
1240

.

2
1
4
9
8

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L
1
1
8

/

2
9

EC  to  evaluate  new  US
standards  if  applicable.

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

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

 
 
 
 
 
European  Community  exports  to  the  United  States

United  States  exports  to  the  European  Community

— Commodity

— Species

— Animal/public health

Trade  conditions

EC
standards

US
standards

Equiv.
(Cat.)

Special conditions

Actions

Trade  conditions

US
standards

EC
standards

Equiv.
(Cat.)

Special  conditions

Actions

11. Fish/fisheries  products  —  public  health  (cont’d)

— Fish/fisheries  products

(cont’d)

Yes 1

NMFS
Voluntary
HACCP
based  Pro-
gramme
50
CFR 260

US  to  conduct  on-site
verification  of  EC
system  (including  visit
to  EC  central  offices
and  observation  of
Commission  audits  of  a
number  of  Member
States).

US  to  indicate  any
outstanding  problems
following  above  actions.

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.

— Bivalve

91/492

molluscs/
crustaceans
(excl. live)

National
shellfish
sanitation
pro-
gramme.

Yes 3 Existing  trade

conditions.

91/492

Yes 3 Existing  trade

conditions.

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

National
shellfish
sanitation
pro-
gramme.

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

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

‘Establishments’  do  not
include  ‘brokers  or
traders’.

Joint  comparison  of
flesh/water  testing  for
classification  of
production  areas.

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

L
1
1
8

/

3
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

2
1
4
9
8

.

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

US  to  conduct  on-site
verification  of  EC
system  (including  visit
to  EC  central  offices
and  observation  of
Commission  audits  of  a
number  of  Member
States).

US  to  indicate  any
outstanding  problems
following  above  actions.

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

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

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

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

‘Establishments’  do  not
include  ‘brokers  or
traders’.

— Aquaculture animals

and  products

91/493
96/22
96/23

NE

National
shellfish
sanitation
pro-
gramme,
FFDCA,
FIFRA,
PHSA,
21  CFR
110.3—
110.93,
123,  1240,
DVM

NE

91/493
96/22
96/23

National
shellfish
sanitation
pro-
gramme,
FFDCA,
FIFRA,
PHSA,
21  CFR
110.3—
110.93,
123,  1240,
DVM

.

2
1
4
9
8

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L
1
1
8

/

3
1

 
 
 
 
 
European  Community  exports  to  the  United  States

United  States  exports  to  the  European  Community

— Commodity

— Species

— Animal/public health

Trade  conditions

EC
standards

US
standards

Equiv.
(Cat.)

12. Live  fish/shellfish  and  gametes

Special conditions

Actions

Trade  conditions

US
standards

EC
standards

Equiv.
(Cat.)

Special  conditions

Actions

Animal health

91/67

NE

91/67

NE

13. Milk  and  milk-based  products  for  human  consumption

Animal health

— Cattle  including

buffalo

— Sheep
— Goats

64/432
92/46

9  CFR  94 Yes 2 Certification  to  UHT  for

FMD  affected  regions.

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

US  to  review  whether
double  pasteurisation
acceptable.

9  CFR  77,
78

92/46
95/343

Yes 2 TB  and  Brucella
requirements  for
non-heat  treated.

EC  to  review  US  TB  and
brucella programmes.

Public  health

— UHT-milk/sterilised

Milk

Yes 3 Existing  trade

conditions.

US  to  review  Import
Milk Act.

US  to  provide  a  detailed
indication  of  how  the
EC  request  for
equivalence  for  low-acid
canned  food  can  be
considered.

Joint  assessment  of
laboratories  to  be
completed.

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

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

Yes 3 EC  requirements  for

somatic  cell  and  plate
counts  certification  as
per  95/343.

US  to  consider  including
HACCP  system  in  dairy
products.

Joint  assessment  of
laboratories  to  be
completed.

Discussions  on  somatic
cells  and  plate  counts  to
continue.

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

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

L
1
1
8

/

3
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

2
1
4
9
8

.

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

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

EC  to  provide
appropriate  information
and  documentation  on
procedures  for  audit
and  control  of
implementation  by
Member  States.  US  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  US  to  provide  a
detailed  indication  of
how  the  EC  request  for
equivalence  to  ‘grade  A’
can  be  considered,  and
thus  to  allow  the
possibility  of  export  of
such  products  to  the  US.

Pasteurised
milk
Ordinance
for
grade A
products
and  related
documents.

Yes 3 Existing  trade

conditions.

US  to  review  Import
Milk Act.

E  coli  requirement  (for
cheeses).

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

Joint  assessment  of
laboratories  to  be
completed.

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

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

Yes 3 EC  requirements  for

somatic  cell  and  plate
counts  certification  as
per  95/343.

US  to  consider  including
HACCP  system  in  dairy
products.

Joint  assessment  of
laboratories  to  be
completed.

Discussions  on  somatic
cells  and  plate  counts  to
continue.

Pasteurised
milk
Ordinance
for
grade A
products
and  related
documents.

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

— Pasteurised  products

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

.

2
1
4
9
8

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L
1
1
8

/

3
3

 
 
 
 
 
European  Community  exports  to  the  United  States

United  States  exports  to  the  European  Community

— Commodity

— Species

— Animal/public health

Trade  conditions

EC
standards

US
standards

Equiv.
(Cat.)

Special conditions

Actions

Trade  conditions

US
standards

EC
standards

Equiv.
(Cat.)

Special  conditions

Actions

13. Milk  and  milk-based  products  for  human  consumption  —  public  health  (cont’d)

— Pasteurised  products

(cont’d)

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

US  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.

US  to  provide
appropriate  information
and  documentation  on
procedures  for  audit  and
control  of
implementation.

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

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

L
1
1
8

/

3
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

Pasteurised
milk
Ordinance
for
grade A
products
and  related
documents.

The  US  to  provide  a
detailed  indication  of
how  the  EC  request  for
equivalence  to  ‘grade  A’
can  be  considered,  and
thus  to  allow  the
possibility  of  export  of
such  products  to  the  US.

Pasteurised
milk
Ordinance
for
grade A
products
and  related
documents.

.

2
1
4
9
8

.

 
 
 
 
 
Yes 3 Compliance  with  E-coli
requirement  (for
cheeses).

— Not  pasteurised  (raw

or  thermised)

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

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

Yes 3 Compliance  with  EC

requirements  for  somatic
cell  and  plate  counts
certification  as  per
95/343.

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

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

Joint  assessment  of
laboratories  to  be
completed.

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

US  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.

US  to  consider  including
HACCP  system  in  dairy
products.

Joint  assessment  of
laboratories  to  be
completed.

Discussions  on  somatic
cells  and  plate  counts  to
continue.

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

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

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

The  US  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  US.

.

2
1
4
9
8

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L
1
1
8

/

3
5

 
 
 
 
 
European  Community  exports  to  the  United  States

United  States  exports  to  the  European  Community

— Commodity

— Species

— Animal/public health

Trade  conditions

EC
standards

US
standards

Equiv.
(Cat.)

Special conditions

Actions

Trade  conditions

US
standards

EC
standards

Equiv.
(Cat.)

Special  conditions

Actions

14. Milk  and  milk-based  products  not  for  human  consumption

Animal health

— Cattle  including

buffalo

— Sheep
— Goats

All  pasteurised  or  UHT
or  sterilised

92/118
64/432

9  CFR
94.16

Yes 2 For  non-FMD  affected
regions,  a  certificate  of
origin  is  required.

For  FMD  affected
regions,  certification  to
UHT.

US  to  review  if  double
pasteurisation  of
products  from  FMD
affected  regions  is
acceptable.

9  CFR  77,
78

92/118
95/341

NE

— Unpasteurised
colostrum  for
pharmaceutical use (10)

92/118

9  CFR
94.16

NE

9  CFR  77,
78

92/118

NE

15. Minced  meat

Animal health

— Ruminants

— Pigs

64/432
72/461
72/462

64/432
72/461
72/462

9  CFR  94 Yes 2 Additional  certification

for  bovines  from  BSE
affected  countries.

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

72/462

NE

9  CFR  94 Yes 1

72/462

NE

L
1
1
8

/

3
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

2
1
4
9
8

.

 
 
 
 
 
Public  health

Ruminants (8)
Pigs

94/65

9  CFR
301—381

Yes 3 Establishments  listed  in
accordance  with
footnote  (7),  and
fulfilling  the  relevant
provisions  of  footnote
(1)

Equivalency  shall  be
granted  after  the  US  has
completed  verification  of
veterinary delivery
systems.  This  process
shall  be  completed
within  12  months  of  the
date  of  entry  into  force
of  this  Agreement.

9  CFR
301—381

94/65
97/29

Yes 3 Derived  from  meat

meeting  the  conditions
of  point  six  (fresh
meat).

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

.

2
1
4
9
8

.

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

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

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  this
Agreement.  EC  to
consider  reviewing  scope
of  definition  of  minced
meat.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L
1
1
8

/

3
7

 
 
 
 
 
European  Community  exports  to  the  United  States

United  States  exports  to  the  European  Community

— Commodity

— Species

— Animal/public health

Trade  conditions

EC
standards

US
standards

Equiv.
(Cat.)

Special conditions

Actions

Trade  conditions

US
standards

EC
standards

Equiv.
(Cat.)

Special  conditions

Actions

16. Meat  preparations

Animal health

— Ruminants

— Equidae

— Pigs

— Poultry/Wild game/

Farmed  game

Public  health

Ruminants (8)
Equidae
Pigs
Poultry

64/432
72/461
72/462

64/432
72/461
72/462

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

9  CFR  94 Yes 2 Additional  certification

for  bovines  from  BSE
affected  countries.

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

72/462

NE

9  CFR  94 Yes 1

72/462

NE

9  CFR  94 Yes 1

NE

91/494
93/342
94/984

94/65

9  CFR
301—381

Yes
2/3

9  CFR
301—381

94/65
97/29

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

Equivalency  shall  be
granted  after  the  US  has
completed  verification  of
veterinary delivery
systems.  This  process
shall  be  completed
within  12  months  of  the
date  of  entry  into  force
of  this  Agreement.

Yes 3 Derived  from  meat

meeting  the  conditions
of  point  6  (fresh  meat)
and/or  7  (poultrymeat).

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

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

L
1
1
8

/

3
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

2
1
4
9
8

.

 
 
 
 
 
The  EC  shall  evaluate  the
US  water  standards  to
determine  whether  they
meet  the  EC  level  of
protection.  This
evaluation  shall  be
completed  within  six
months  of  the  entry  into
force  of  this  Agreement.
Equivalency  shall  be
granted  after  the  EC  has
completed  verification  of
the  application  of  the
specified  conditions.  This
process  shall  be
completed  within  12
months  of  the  entry  into
force  of  this  Agreement.

Wild game (8)
Farmed  game (8)

94/65

NE

Existing  trade  conditions

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

94/65

NE

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

17. Animal  casings  for  human  consumption

Animal health

— Cattle

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

9  CFR  96 Yes 2 Non-comminglement

(see  footnote  (9))

No  trade  allowed  for
countries  affected  by
BSE.

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

US  to  review  94.8 (a)
(i) (v)  of  CFR  for
non-comminglement.

92/118
94/187

NE

.

2
1
4
9
8

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L
1
1
8

/

3
9

 
 
 
 
 
European  Community  exports  to  the  United  States

United  States  exports  to  the  European  Community

— Commodity

— Species

— Animal/public health

Trade  conditions

EC
standards

US
standards

Equiv.
(Cat.)

Special conditions

Actions

Trade  conditions

US
standards

EC
standards

Equiv.
(Cat.)

Special  conditions

Actions

17. Animal  casings  for  human  consumption  —  animal  health (cont’d)

— Pigs

— Sheep
— Goats

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

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

Public  health

77/99

9  CFR  96 Yes 2 Non-comminglement

(see  footnote  (9)).

US  to  review
94.8 (a) (i) (v)  of  CFR  for
non-comminglement.

92/118
94/187

NE

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

9  CFR  96 Yes 2 Non-comminglement

(see  footnote  (9)).

US  to  review
94.8 (a) (i) (v)  of  CFR  for
non-comminglement.

92/118
94/187

NE

No  trade  allowed  for
countries  affected  by
BSE.

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

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
notified
to  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

L
1
1
8

/

4
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

2
1
4
9
8

.

 
 
 
 
 
18. Animal  casings  not  for  human  consumption

Animal health

— Cattle

— Pigs

— Sheep
— Goats

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

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

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

9  CFR  96 Yes 2 Non-comminglement

(see  footnote  (9)).

No  trade  allowed  for
countries  affected  by
BSE.

9  CFR  96 Yes 2 Non-comminglement

(see  footnote  (9)).

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

US  to  review
94.8 (a) (i) (v)  of  CFR  for
non-comminglement.

US  to  review
94.8 (a) (i) (v)  of  CFR  for
non-comminglement.

92/118
94/187

NE

92/118
94/187

NE

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

9  CFR  96 Yes 2 Non-comminglement

(see  footnote  (9)).

US  to  review
94.8 (a) (i) (v)  of  CFR  for
non-comminglement.

92/118
94/187

NE

No  trade  allowed  for
countries  affected  by
BSE.

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

19. Hides  and  skins

Animal health

— Cattle
— Sheep
— Goats
— Pigs

92/118
72/461
72/462

9  CFR
95.5,
95.6

Yes 1

92/118
97/168

E

EC  to  identify  basis  for
salting requirement.

.

2
1
4
9
8

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L
1
1
8

/

4
1

 
 
 
 
 
European  Community  exports  to  the  United  States

United  States  exports  to  the  European  Community

— Commodity

— Species

— Animal/public health

Trade  conditions

EC
standards

US
standards

Equiv.
(Cat.)

Special conditions

Actions

Trade  conditions

US
standards

EC
standards

Equiv.
(Cat.)

Special  conditions

Actions

20. Canned  petfood  containing  high/low  risk  material

Yes 2 Special  rules  for  BSE

countries.

Shelf  stable  for
remainder.

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

Yes 2 Shelf  stable  for

remainder.

— Containing

mammalian material

92/118
90/667
92/562

— Containing  only
non-mammalian
material

92/118
90/667
92/562

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

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

21. Canned  petfood  containing  only  low  risk  material

— Containing

mammalian material

92/118
90/667

Yes 2 Special  rules  for  BSE

countries.

Shelf  stable  for
remainder.

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

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

E

E

E

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

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

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

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

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

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

EC  to  examine  US  claim
to  be  BSE  free.

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

Establishments  shall
have  been  validated  by
the  US  for  alternative
heat  treatment  including
30  day  freedom  from
clostridia.

L
1
1
8

/

4
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

2
1
4
9
8

.

 
 
 
 
 
— Containing  only
non-mammalian
material

92/118
90/667

Yes 2 Shelf stable.

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

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

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

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

Yes 2 Restrictions  for  BSE

countries.

92/118
94/309

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

US  to  examine  EC  90 °C
core  temperature
requirement  as  providing
sufficient  guarantees
against  FMD,  CSF,
SVD,  ASF  and  ND.

US  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

23. Dry  and  semi  moist  petfood  containing  high/low  risk  material

— Containing

mammalian material

92/118
94/309

— Containing  only
non-mammalian
material

92/118
94/309

Yes 2 Restrictions  for  BSE

countries.

Yes 1

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

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

US  to  examine  EC  90 °C
core  temperature
requirement  as  providing
sufficient  guarantees
against  FMD,  CSF,
SVD,  ASF  and  ND.

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

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

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

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

92/118
94/344
97/199

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

E

E

E

E

Establishments  shall
have  been  validated  by
the  US  for  alternative
heat  treatment  including
30  day  freedom  from
clostridia.

Establishments  shall
have  been  validated  by
the  US  for  alternative
heat  treatment  including
30  day  freedom  from
clostridia.

Establishments  shall
have  been  validated  by
the  US  for  alternative
heat  treatment  including
30  day  freedom  from
clostridia.

.

2
1
4
9
8

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L
1
1
8

/

4
3

EC  to  examine  US  claim
to  be  BSE  free.

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

 
 
 
 
 
European  Community  exports  to  the  United  States

United  States  exports  to  the  European  Community

— Commodity

— Species

— Animal/public health

Trade  conditions

EC
standards

US
standards

Equiv.
(Cat.)

Special conditions

Actions

Trade  conditions

US
standards

EC
standards

Equiv.
(Cat.)

Special  conditions

Actions

24. Bones  and  bone  products  for  human  consumption  (‘other  products’  as  defined  in  Directive  77/99/EEC)

Animal health

Fresh  meat  (ruminants,
horses,  pigs)

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

9  CFR  95 Yes 2 Restrictions  for  BSE

countries.

Farmed  game
— Pigs, deer

91/495

9  CFR  95 Yes 2 Restrictions  for  BSE

countries.

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

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

72/462
97/221

NE

91/495

NE

Fresh  meat
— Poultry

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

9  CFR  95 Yes 1

92/118

NE

Feathered,  farmed  and
wild game

92/45
91/495

9  CFR  95 Yes 1

Wild game
— Pigs, deer

92/45

9  CFR  95 Yes 2 Restrictions  for  BSE

countries.

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

92/45
91/495

NE

92/45

NE

Public  health

All species (8)

77/99
92/118

9  CFR  95 NE

77/99
92/118

NE

EC  to  consider
establishing conditions.

L
1
1
8

/

4
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

2
1
4
9
8

.

 
 
 
 
 
Feathered,  farmed  and
wild game (8)

64/433
77/99
92/118

NE

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

NE

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

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

25. Bones,  horns  and  hooves  and  their  products  not  for  human  consumption

Animal health

96/239

9  CFR  95 Yes 1

9  CFR  53 94/446

NE

26. Processed  animal  protein  for  human  consumption

Animal health

Fresh  meat  (ruminants,
equidae,  pigs)

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

9  CFR  95 Yes 2 Not  accepted  from  BSE

countries.

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

72/462
97/221

NE

Farmed  game
— Pigs, deer

91/495

9  CFR  95 Yes 2 Not  accepted  from  BSE

countries.

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

91/495

NE

Fresh  meat
— Poultry

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

9  CFR  95 Yes 1

92/118

NE

Feathered,  farmed  and
wild game

92/45
91/495

9  CFR  95 Yes 1

92/45
91/495

NE

.

2
1
4
9
8

.

EC  to  examine  US  claim
to  be  BSE  free.

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

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L
1
1
8

/

4
5

 
 
 
 
 
European  Community  exports  to  the  United  States

United  States  exports  to  the  European  Community

— Commodity

— Species

— Animal/public health

Trade  conditions

EC
standards

US
standards

Equiv.
(Cat.)

Special conditions

Actions

Trade  conditions

US
standards

EC
standards

Equiv.
(Cat.)

Special  conditions

Actions

26. Processed  animal  protein  for  human  consumption  —  Animal  health  (cont’d)

Wild game
— Pigs, deer

92/45

9  CFR  95 Yes 2 Not  accepted  from  BSE

countries.

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

92/45

NE

Public  health

All species (8)

Feathered,  farmed  and
wild game (8)

77/99
92/118

77/99

Yes 1

NE

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

27. Processed  animal  protein  not  for  human  consumption

Containing  material  of  mammalian  origin

Ruminants

92/118
90/667

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

Yes 2 Not  accepted  from  BSE

countries.

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

NE

NE

77/99
92/118

77/99
92/118
Draft
Decisions
notified
to  WTO.

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

NE

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

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

EC  to  examine  US  claim
to  be  BSE  free.

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

L
1
1
8

/

4
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

2
1
4
9
8

.

 
 
 
 
 
Non-ruminants

92/118
90/667

Yes 3

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

Containing  only  material  of  non-mammalian  origin

Poultry  and  fish

92/118
90/667

9  CFR  95 Yes 1

Non-ruminants

92/118
90/667

9  CFR  95 Yes 1

28. Serum  of  equidae

Animal health

92/118
94/143

9  CFR  95,
122

NE

29. Blood  and  blood  products  intended  for  human  consumption

NE

92/118
90/667
96/449

Establishments  shall
have  been  validated  by
the  US  for  alternative
heat  treatment  including
30  day  freedom  from
clostridia.

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

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

NE

Establishments  shall
have  been  validated  by
the  US  for  alternative
heat  treatment  including
30  day  freedom  from
clostridia.

92/118
90/667

NE

92/118
94/143

NE

Animal health

Fresh  meat  (ruminants,
equidae,  pigs)

9  CFR  95,
122

E

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

BSE  rules  for  ruminants. US  to  review  rules  on

BSE  with  respect  to
high/low incidence
regions.

US  to  produce  generic
conditions  for  EC.

9  CFR  53 72/462
97/221

NE

Farmed  game
— Pigs, deer

91/495

9  CFR  95,
122

Yes 2 BSE  rules  for  ruminants. US  to  review  rules  on

91/495

NE

BSE  with  respect  to
high/low incidence
regions.

Fresh  meat
— Poultry

9  CFR  95,
122

Yes 1

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

92/118

NE

.

2
1
4
9
8

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L
1
1
8

/

4
7

 
 
 
 
 
European  Community  exports  to  the  United  States

United  States  exports  to  the  European  Community

— Commodity

— Species

— Animal/public health

Trade  conditions

EC
standards

US
standards

Equiv.
(Cat.)

Special conditions

Actions

Trade  conditions

US
standards

EC
standards

Equiv.
(Cat.)

Special  conditions

Actions

29. Blood  and  blood  products  intended  for  human  consumption  —  animal  health (cont’d)

Feathered,  farmed
and  wild  game

92/45
91/495

9  CFR  95,
122

Yes 1

Wild game
— Pigs, deer

92/45

9  CFR  95,
122

Yes 1

Public  health

77/99

NE

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

92/45
91/495

NE

92/45

NE

NE

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

EC  to  consider
establishing conditions.

Animal health

92/183
92/118

9  CFR
95.4,  122

Yes 2 BSE  rules  for  ruminants.
Permit  required.

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

9  CFR  53 92/183
92/118

Yes 2 Bluetongue  treatment
requirements.

EC  to  consider  use  of
tests  for  bluetongue  in
place  of  treatment.

31. Lard  and  rendered  fats  intended  for  human  consumption

Animal health

Fresh  meat
(ruminants,  horses,  pigs)

64/432
72/461
80/215

9  CFR  95 Yes 2 BSE  rules  for  ruminants. US  to  review  rules  on

BSE  with  respect  to
high/low incidence
regions.

72/462
97/221

NE

L
1
1
8

/

4
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

2
1
4
9
8

.

 
 
 
 
 
Farmed  game
— Pigs, deer

Fresh  meat
— Poultry

Feathered,  farmed
and  wild  game

Wild game
— Pigs, deer

Public  health

All species (8)

Feathered,  farmed
and  wild  game (8)

91/495

9  CFR  95 Yes 2 BSE  rules  for  ruminants. US  to  review  rules  on

91/495

NE

BSE  with  respect  to
high/low incidence
regions.

92/118
80/215
94/438

92/45
91/495

9  CFR  95 Yes 1

92/118

NE

9  CFR  95 Yes 1

92/45
91/495

NE

92/45

9  CFR  95 Yes 2 BSE  rules  for  ruminants. US  to  review  rules  on

92/45

NE

BSE  with  respect  to
high/low incidence
regions.

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,
510—529,
556

NE

NE

77/99
92/118

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

9  CFR
301—381,
416,  417
FIFRA,
PHSA,
FFDCA,
21  CFR
70—82,
108,  109,
110.3—
110.93,
113,
170—189,
510—529,
556

32. Lard  and  rendered  fats  not  intended  for  human  consumption

92/118
90/667
72/461

9  CFR  95 Yes 2 BSE  rules  for  ruminants. US  to  review  rules  on

BSE  with  respect  to
high/low incidence
regions.

NE

92/118
Draft
Decision
notified
to  WTO.

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

EC  to  review  US
bacteriological testing
regime  for  protein
fraction.

.

2
1
4
9
8

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
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i
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i
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s

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4
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European  Community  exports  to  the  United  States

United  States  exports  to  the  European  Community

— Commodity

— Species

— Animal/public health

Trade  conditions

EC
standards

US
standards

Equiv.
(Cat.)

Special conditions

Actions

Trade  conditions

US
standards

EC
standards

Equiv.
(Cat.)

Special  conditions

Actions

33. Raw  material  for  feeding  stuffs,  pharmaceutical  or  technical  use

Animal health

92/118

9  CFR  95,
122

Yes 1

9  CFR  53 92/118

E

EC  to  consider  laying
down  certification
requirements  for  imports.

34. Apiculture  products  for  apiculture

Animal health

92/118

E

35. Game  trophies

Animal health

92/118

9  CFR  95 Yes 1

36. Manure

Animal health

92/118

9  CFR  95 E

37. Wool,  feathers  and  hair

Animal health

92/118
94/860

NE

9  CFR  53 92/118
96/590

E

9  CFR  53 92/118

E

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

— Wool

92/118

9  CFR  95 Yes 1

9  CFR  53 92/118

NE

— Pig  bristles

92/118

9  CFR  95 Yes 1

Public  health

NE

FFDCA,
PHSA
21  CFR
1240.70

9  CFR  53 92/118
94/435

FFDCA,
PHSA
21  CFR
1240.70

NE

NE

L
1
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8

/

5
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

2
1
4
9
8

.

 
 
 
 
 
38. Honey

Animal health

Public  health

92/118

NE

NE

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

39. Frogs’  legs

Animal health

Public  health

92/118
96/340

NE

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

40. Snails  for  human  consumption

Animal health

Public  health

92/118
96/340

NE

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

.

2
1
4
9
8

.

NE

92/118

NE

92/118
96/340

NE

EC  to  review  US  HACCP
rules  when  submitted.

92/118
96/340

NE

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

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

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

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L
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1
8

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5
1

 
 
 
 
 
European  Community  exports  to  the  United  States

United  States  exports  to  the  European  Community

— Commodity

— Species

— Animal/public health

Trade  conditions

EC
standards

US
standards

Equiv.
(Cat.)

41. Egg  products  for  human  consumption

Special conditions

Actions

Trade  conditions

US
standards

EC
standards

Equiv.
(Cat.)

Special  conditions

Actions

Animal health

90/539

9  CFR  94 Yes 2 Permit  required  from

areas  affected  by
Newcastle disease.

US  to  review  permit
requirement.

90/539
93/342

Yes 1

Public  health

89/437
91/684
92/118
96/23

E

7  CFR  59
EPIA
Public
Law
91-597

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

E

7  CFR  59
EPIA
Public
Law
91-597

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

US  to  complete
assessment  of  EC  public
health legislation.

EC  to  complete
assessment  of  US  public
health legislation.

Establishments  listed  in
accordance  with
footnote  (7),  and
fulfilling  the  relevant
provisions  of
footnote  (2).

The  following  tests  are
to  be  conducted,  as
specified  in  Annex  VI  to
Directive  89/437,  on  US
egg  products  for
dispatch  to  Europe:

Chemical  tests
— 3  OH  butyric  acid
— lactic acid
— succinic acid
— egg  shell  remains,  egg
membrane,  other
particles.

Bacteriological tests
— mesophile  counts
— enterobacteriaceae
— salmonella
— staphylococcus

Methods
Internationally recognised
methods  such  as:  ISO,
NMKL,  AOAC.

L
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5
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

2
1
4
9
8

.

 
 
 
 
 
42. Shell eggs

Animal health

90/539

9  CFR  94 Yes 2 Permit  required  from

areas  affected  by
Newcastle disease.

US  to  review  permit
requirement.

9  CFR  94 90/539
93/342

Yes 1

Public  health

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

E

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,
178,  520,
524,  556,
558,  1240
40  CFR
180
7  CFR  56

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,
109,
110.3—
110.93,
570,
573—589

US  to  review  legal  basis
for  recognition  of
equivalence.

US  to  complete
assessment  of  EC  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,
178,  520,
524,  556,
558,  1240
40  CFR
180
7  CFR  56

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

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

E

Footnote  (4).

EC  to  complete
assessment  of  US  public
health legislation.

NE

92/118

NE

.

2
1
4
9
8

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
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C
o
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i
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i
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s

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L 118/54

EN

Official  Journal  of  the  European  Communities

21.4.98

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  USA  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,  fresh  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  is  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.

(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  programme  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  metres  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.

21.4.98

EN

Official  Journal  of  the  European  Communities

L 118/55

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

(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.

(f) 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.

FOOTNOTE  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

Unpackaged  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,  sprays  and  hoses

Meat  shall  not  be  contaminated  by  splashing.

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

(f) Sterilisation  of  equipment

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

FOOTNOTE  4

Additional  guarantees  for  Finland  and  Sweden

For  trade  from  the  USA  to  Sweden  and  Finland,  the  USA  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  Council  Directive  72/462/EEC  intended  for  an
establishment  for  the  purposes  of  pasteurisation,  sterilisation  or  for  treatment  having  an  equivalent  effect.

L 118/56

EN

Official  Journal  of  the  European  Communities

21.4.98

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  aand  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,

— 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.

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  one  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  9  CFR  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 one 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  USA  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  one  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, offal 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 carcase is condemned its offal and
blood  shall  also  be  condemned.

(g) Partial approval

The  veterinary  authorities  of  the  EC  and  the  USA  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:

21.4.98

EN

Official  Journal  of  the  European  Communities

L 118/57

1.

2.

3.

4.

5.

the  establishment  shall  develop  a  quality  assurance  (QA)  programme  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  programme  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  programme  and  document  such  monitoring  and  ensure  correction  of  deficiencies;

the importing Party may verify the practical implementation of the QA programme. In this case, the
establishment  needs  to  be  in  a  position  to  demonstrate  the  programme  on  the  spot  during  an
inspection.  For  this  purpose,  all  relevant  documentation  shall  be  presented;

6.

should  an  inspection  on  the  spot  and/or  the  document-check  in  an  establishment  reveal  serious
deficiencies,  the  possibility  of  partial  approval  may  either  be  refused  or  revoked.

FOOTNOTE  6

Poultrymeat

(a) Counterflow  chilling

Where  counterflow  chilling  systems  are  used,  alternative  chilling  systems  to  the  EC  standards  may  be
used  providing  equivalent  guarantees  as  regards  avoidance  of  cross  contamination,  and  carcase
temperatures at the point of exit from the chilling systems as set out under point (b), 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.

(b) Poultry  product  temperature  requirements

Poultry  shall  be  chilled  to  an  internal  temperature  of  40 °F  (4,4 °C)  in  the  shortest  time  possible  after
slaughter.

— In  the  case  of  small  birds  (up  to  6  lbs),  the  internal  temperature  of  40 °F  shall  be  achieved  by  the

end  of  the  immersion  chilling  process,

— where crushed ice is used to chill large birds (over 6 lbs) 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 °F,  the  internal
temperature  may  exceed  40 °F  for  a  maximum  of  one  hour,  but  may  not  exceed  50 °F  (10 °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.

FOOTNOTE  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

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additions and deletions to such lists, shall be supplied to the importing Party by the exporting Party. The
importing Party shall make modifications to the lists of approved establishments efficiently, on the basis
of  the  information  supplied  by  the  exporting  Party.  Dissemination  of  such  lists  shall  be  carried  out
without  delay (*).

2. The importing Party may carry out verification procedures, including inspection of the establishments, to

ensure  that  the  relevant  requirements  are  being  met.

3. The Parties will work towards increasing the responsibility for the management of lists of establishments
by  the  exporting  Party  in  the  light  of  experience  obtained  under  the  operation  of  the  provisions  of
paragraphs  1  and  2.

4. The  Parties  will  review  the  functioning  of  the  abovementioned  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.

FOOTNOTE  8

Bison  and  Water  Buffalo

For  exports  to  the  USA,  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-comminglement  —  meat,  meat  products,  game  meat,  poultry  meat,  minced  meat,  meat  preparations

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

1. Animals from which the meat is intended for export shall be kept separate from those which are not of

the  same  status  while  at  the  slaughter  establishment.

2. Following slaughter of animals which are not eligible for export and before slaughter of animals eligible
for  export  purposes,  all  areas,  utensils  and  equipment  liable  to  contact  the  live  animals  and  meat,
including  stunning,  bleeding,  flaying,  deboning,  cutting  and  packing  areas  shall  be  cleaned  and
disinfected.  Staff  shall  change  into  clean  protective  clothing  and  wash  their  hands  and  boots
thoroughly.

3. Meat intended for export shall not be handled, cut or otherwise processed in the same room at the same

time  as  meat  not  eligible  for  export.

4. Meat  intended  for  export  shall  be  packed  in  clean  new  packaging  which  is  clearly  distinguishable  from
that containing meat not eligible for export. It shall be stored in such a way as to ensure that no cross
contamination  occurs.

5. Records of the origin of the animals from which the meat is produced shall be retained for a period of

six  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  USA.

FOOTNOTE  11

Residue  testing

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

(*) The  EC  will  carry  out  this  commitment  in  accordance  with  the  procedure  laid  down  in  Article  5  of  Council  Decision

95/408/EC.  The  USA  will  carry  out  this  commitment  in  accordance  with  a  similar  timetable.

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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  processing  plants  where  animals  or  animal  products  might  be  handled,
excluding  retail  premises.

2.

General principles

2.1. The auditor and the auditee should cooperate 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.

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;

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

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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,

— 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  auditee  will  cooperate  fully  with  the  auditor  in  the  document  review  process  and  help  to  ensure

that  the  auditor  has  access  to  requested  documents  and  records.

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  cooperate  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,

— training programmes.

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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  are  clearly  understood.

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 on 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.

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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 their 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.

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.

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ANNEX  IX

CONTACT  POINTS

The USA 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

Tel.  1 202 862 9560

Fax  1 202 429 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

US  Mission  of  the  European  Union

40  Blvd  du  Regent

B-1000  Brussels

Tel.  32 2 508 2760

Fax  32 2 511 0918