Communication from the Council - EC/US veterinary agreement
Date: 1998-05-01
Institutions: Council of the European Union
Subjects: United States, agreement (EU), animal health, health legislation, public health, veterinary legislation

1.5.98

EN

Official  Journal  of  the  European  Communities

C  136/1

I

(Information)

COUNCIL

EC/US  VETERINARY  AGREEMENT

(98/C  136/01)

(This  text  cancels  and  replaces  the  text  published  in  OJ  C  122  of  21  April  1998)

When  adopting  the  Decision  on  the  conclusion  of  the  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(cid:216)(˛),  the  Council  approved  the
following  declaration:

"The  Council  takes  note  of  the  exchange  of  letters  between  the  Commission  and  the
United  States  Department  of  Agriculture  and  agrees  to  include  these  letters  in  its  minutes.

The  Council  stresses  that  these  letters  are  an  essential  element  of  its  decision  relating  to
the  approval  of  the  EC/US  Veterinary  Agreement.

The  Council  and  the  Commission  consider  that  the  political  commitments  set  out  in  these
letters  are  essential  to  ensure  a  proper,  balanced  and  full 
implementation  of  the
Agreement.

The  Commission  undertakes,  that  in  accordance  with  the  procedure  foreseen  in  Article  4
of  the  Council  Decision,  it  will  utilise  the  provisions  of  Article  14  of  the  Agreement  to
deal  with  any  problems  of  implementation  which  arise,  bearing  in  mind,  in  particular,  the
importance  attached  by  the  Council  in  its  decision  to  the  letters  from  the  United  States.
The  Commission  also  undertakes  that,  should  problems  of  the  nature  referred  to  above
prove  impossible  to  resolve,  it  will  take  the  necessary  procedural  steps  to  enable  the
Council  to  take  the  action  foreseen  under  Article  16  of  the  Agreement  and  will  use  the
resources  on  which  the  Community  may  call  pursuant  to  Article  2  of  this  Agreement.

In  any  case  it  is  clear  that  the  Commission  needs  to  take  a  number  of  implementing
decisions  within  the  framework  of  the  Standing  Veterinary  Committee.  The  Commission
foresees  that  the  implementation  into  national  legislation  will  take  a  few  months,  in
conformity  with  Article  8  of  the  Agreement,  from  the  moment  of  the  signing  of  the
Agreement.  During  this  period  the  Commission  will  closely  monitor  the  implementation
on  the  US  side.

The  Council  agrees  to  publish  this  declaration  and  the  abovementioned  letters  in  the
Official  Journal  of  the  European  Communities  (series  C).’

(˛)(cid:217)OJ  L  118,  21.4.1998,  p.  1;  corrigendum  OJ  L  130,  1.5.1998.

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Official  Journal  of  the  European  Communities

1.5.98

ANNEX  I

March  10,  1998

Franz  Fischler
Agricultural  Commissioner
Commission  of  the  European  Union
Rue  de  la  Loi  200
B(cid:220)1049  Brussels

Dear  Franz,

In  our  meeting  in  Oxford  last  January,  we  had  a  lengthy  discussion  of  the  actions  we  intended  to  take  to
recognize,  under  the  terms  of  our  draft  Veterinary  Equivalency  Agreement  (the  Agreement),  the  animal
health  status  of  the  European  Community  (EC).  I  explained  to  you  that  it  would  be  impossible  for  us  to
publish  a  second  proposed  rule  on  animal  health  status  before  the  EC  Council  voted  to  adopt  the
Agreement.  However,  I  did  promise  to  provide  to  you,  before  the  date  of  the  Council  vote,  an  indication
of  the  likely  content  of  the  proposal.  This  letter  is  in  fulfillment  of  that  commitment.

Our  regionalization  obligation  under  the  Agreement  extends  to  the  seventeen  diseases  listed  in  Annex  III  of
the  Agreement.  To  ensure  complete  clarity,  I  would  like  to  describe  the  situation  with  respect  to  each  of
those  seventeen  diseases.

For  eleven  of  the  diseases  -  namely,  peste  de  petits  ruminants,  contagious  caprine  pleuropneumonia,  sheep
and  goat  pox,  enterovirus  encephalomyelitis,  pseudorabies/aujeszky’s,  vesicular  stomatitis,  contagious
bovine  pleuropneumonia,  bluetongue,  African  horse  sickness,  fowl  plague  (avian  influenza),  and  Vene(cid:220)
zuelan  equine  encephalomyelitis  -  the  United  States  already  recognizes  the  EC’s  animal  health  status  as
defined  by  the  Community.  There  is,  therefore,  no  need  for  further  action.

November  1997  Proposed  Rule:  In  July  1997,  the  Animal  and  Plant  Health  Inspection  Service  (APHIS)
received  a  request  from  the  European  Commission  for  the  recognition  of  the  animal  health  status  of
Member  States  and  their  regions  for  the  remaining  six  diseases  -  swine  vesicular  disease  (SVD),
Newcastle  disease  (ND),  rinderpest,  foot(cid:220)and(cid:220)mouth  disease  (FMD),  classical  swine  fever  (CSF),  and
African  swine  fever  (ASF).  Based  on  the  information  which  was  provided,  APHIS  published  a  proposed
rule  in  November  1997,  under  the  terms  of  which  the  United  States  would  recognize  Belgium  free  of  SVD;
France  free  of  SVD  and  ND;  Greece  free  of  rinderpest  and  ND;  Luxembourg  free  of  FMD,  rinderpest,
and  ND;  Portugal  free  of  FMD,  rinderpest,  SVD,  and  ASF;  and  Spain  free  of  ND.

If  that  rule  is  finalized  as  written,  and  I  expect  that  it  will  be  shortly,  the  United  States  will  have
recognized  the  EC’s  animal  health  status  for  two  more  diseases  -  ASF  and  rinderpest  -  as  defined  by  the
EC.

With  respect  to  the  other  four  disease,  we  had  not  received  by  the  time  of  the  publication  of  the  original
proposed  rule  sufficient  information  from  the  EU  to  allow  us  to  make  determinations  with  respect  to
certain  Member  States  and  regions.  Information  received  subsequently,  however,  has  given  us  a  more
complete  picture.

Foot(cid:220)and(cid:220)Mouth  disease:  Based  on  the  new  information  we  have  received  on  FMD,  we  are  now  prepared
to  begin  the  rulemaking  process  to  recognize  Greece  as  FMD(cid:220)free.  Completion  of  that  process  and  final(cid:220)
ization  of  the  November  proposed  rule  would  mean  that  the  U.S.  disease  picture  for  FMD  would
correspond  with  that  of  the  EC.

Swine  vesicular  disease:  With  regard  to  SVD,  we  have  nearly  a  complete  picture.  On  the  basis  of  the  data
provided,  we  are  now  prepared  to  propose  the  recognition  of  the  EC  disease  map  for  all  regions  except  for
the  central  and  southern  regions  of  Italy  for  which  we  have  not  yet  received  sufficient  surveillance  data.
Once  we  have  received  and  evaluated  such  information,  we  would  be  able  (if  the  data  are  satisfactory)  to
complete  the  EC  picture  with  regard  to  SVD.  Prompt  receipt  of  the  information  could  allow  us  to  make  a
positive  determination  prior  to  formal  publication  of  the  proposal  in  the  Federal  Register.

Classical  swine  fever  and  Newcastle  disease:  With  regard  to  the  remaining  two  diseases,  I  am  frankly  very
concerned.  The  situation  in  Europe  is  far  from  stable,  and  our  regulatory  officials  are  anxious  to  ensure
that  implementation  of  the  Agreement  does  not  expose  U.S.  livestock  and  poultry  flocks  to  unacceptable
risks.  I  coming  to  conclusions  on  these  two  diseases,  I  have  instructed  APHIS  to  go  as  far  as  can  be
scientifically  justified.  However,  I  have  also  instructed  them  to  demand  full  information  and  to  make
prudent  judgements.

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On  the  basis  of  the  information  we  have  received  with  respect  to  CSF,  we  are  prepared  to  begin  the
rulemaking  process  for  recognizing  the  EC’s  animal  health  status  as  defined  by  the  EC.  Moreover,  we
would  intend  to  include  in  our  proposed  rule  references  to  regionalization  efforts  in  place  in  infected
regions.  This  should  facilitate  the  task  of  changing  the  status  of  those  areas  once  the  disease  is  eradicated.
However,  in  light  of  the  length,  severity  and  repetitive  nature  of  the  outbreaks,  we  intend  to  propose  two
special  conditions.  First,  in  the  case  of  future  outbreaks,  we  would  request  the  EC  provide  us  with
information  on  all  shipments  to  the  United  States  from  the  newly(cid:220)infected  area  for  40  days  prior  to  the
outbreak.  Second,  we  would  stipulate  that,  in  the  case  of  this  disease,  infected  areas  would  not  be
determined  disease(cid:220)free  until  they  had  completed  the  full  six(cid:220)month  waiting  period  prescribed  by  the  Inter(cid:220)
national  Office  of  Epizootics  (OIE).

With  respect  to  ND,  we  have  received  from  the  Commission  little  information  on  surveillance.  In  addition,
we  are  concerned  by  the  Community’s  inability  to  identify  the  source  of  the  recent  outbreaks  and  the  lack
of  harmonized  regulations  on  the  movement  of  pet  birds.  Therefore,  we  are  not  in  a  position  at  this  time  to
extend  the  disease(cid:220)free  recognition  for  ND  beyond  what  we  have  already  outline  in  our  November  1997
proposed  rule.  However,  additional  data  and  information  obtained  from  he  Commission  supporting  disease
free  status  would  allow  adjustments  prior  to  the  formal  publication  of  the  proposal  in  the  Federal  Register.

I  am  confident  that  we  are  acting  in  conformity  with  our  obligations  under  the  draft  Agreement  and  the
Agreement  on  Sanitary  and  Phytosanitary  Measures.  We  look  forward  to  the  adoption  and  implementation
of  the  Agreement,  and  to  working  with  you  under  the  Agreement  to  resolve  outstanding  issues  to  the
satisfaction  of  both  parties.

Sincerely,

Dan  Glickman

Secretary

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Official  Journal  of  the  European  Communities

1.5.98

ANNEX  II

February  24,  1998

Mr.  Guy  Legras
Director  General
Directorate(cid:220)General  VI
Commission  of  the  European  Community
Rue  de  la  Loi  200
B(cid:220)1049  Brussels

Dear  Mr.  Legras,

I  refer  to  the  29  January  letter  from  David  Roberts  to  Paul  Drazek  concerning  the  U.S.  position  on  animal
health  and  regionalization  issues.  That  letter  accurately  identifies  the  main  issues  that  arose  during  our
recent  meetings  in  Brussels.  By  way  of  response  to  that  letter,  I  can  confirm  that  the  U.S.  interpretation  of
the  agreement  is  that  the  initial  presumption  in  every  case  is  that  the  regionalization  decision  taken  by  the
other  party  will  be  accepted,  allowing  for  exceptional  cases  in  which,  for  good  and  justifiable  reasons,  the
party  feels  that  need  to  take  recourse  under  the  safeguard  provision.  Thus,  in  the  ordinary  case,  we  expect
the  agreement  to  operate  as  follows:

-(cid:217)In  the  case  where  the  EC  takes  a  decision  to  restrict  an  area  that  has  previously  been  recognized  as
disease(cid:220)free,  the  United  States  would  accept  the  EU’s  regionalization  decision  without  having  to  take
further  actions;

-(cid:217)When,  subsequently,  a  disease  incident  had  been  appropriately  dealt  with  and  the  EC  lifts  restrictions

on  that  area,  the  United  States  would  accept  that  decision  without  having  to  take  further  action.

In  order  to  obviate  the  need  for  rulemaking  in  every  instance  in  which  the  EC  might  take  such  a  decision
to  impose  or  lift  restrictions  in  an  area  previously  recognized  disease(cid:220)free,  USDA  would  include  provisions
in  our  new  proposed  rule  on  EC  animal  health  status  to  the  effect  that  animals  or  animal  products  whose
free  movement  in  the  EC  is  restricted  are  similarly  restricted  from  importation  into  the  United  States.

-(cid:217)Where  a  region  that  has  previously  been  infected  with  a  disease  is  being  recognized  as  disease(cid:220)free  for
the  first  time,  USDA  is  required  to  proceed  by  rulemaking  to  change  its  recognition  of  disease  status.
This  includes  publishing  a  proposed  rule  based  on  full  technical  and  scientific  information,  allowing
public  comment,  and  issuing  a  final  rule.  However,  we  fully  anticipate  that  we  will  be  able  to  comply
with  these  domestic  requirements  to  conduct  rulemaking  in  a  manner  that  will  permit  us  to  accept  and
recognize  EC  regionalization  decisions  in  the  ordinary  case.

Our  policy  would  be  to  initiate  rulemaking  by  publishing  our  proposed  rule  during  the  waiting  period
required  by  the  OIE  before  a  region  may  be  declared  disease(cid:220)free.

Previously,  APHIS  policy  was  to  require  that  a  country  be  free  of  disease  for  the  entire  OIE  time  frame  or
longer  before  it  initiated  rulemaking.  However,  in  light  of  our  agreement,  we  consider  that  it  would  be
appropriate  to  initiate  rulemaking  once  we  have  received  thorough  and  complete  information  that  the  last
case  of  the  disease  has  been  eliminated  from  the  region,  including  details  of  the  regionalization  measures  in
place.  The  proposed  rule  would  contain  reference  to  such  measures.  The  publication  of  the  final  rule  would
be  contingent  on  the  fact  that  no  additional  cases  of  the  disease  are  discovered  in  the  region  during  the
OIE  period.  Normally,  the  required  rulemaking  can  be  conducted  within  the  OIE  waiting  period.

Although  this  response  attempts  to  clarify  our  interpretation  and  position  with  respect  to  the  obligations
incorporated  in  Article  6  of  the  Agreement,  it  is  implicit  that  the  proper  functioning  of  the  Agreement  will
depend,  of  course,  on  both  parties  exercising  their  responsibilities  under  all  provisions  of  the  Agreement.  I
would  note,  in  this  regard,  that  we  consider  that  the  provisions  of  Article  6  are  closely  tied  to  the
provisions  of  Article  10  and  11  requiring  the  parties  to  keep  each  other  fully  informed  of  their  actions  and
the  bases  for  those  actions.  In  addition,  we  recognize  that  there  may  be  exceptional  cases  -  e.g.,  where
there  has  been  a  disease  outbreak  which  achieves  significant  geographical  spread  or  which  persists  for  a
significant  duration  -  in  which  the  parties  will  not  agree  on  what  action  is  appropriately  indicated  by  the
circumstances,  and  in  those  cases,  the  obligations  under  Article  6  are  clearly  balanced  by  the  rights  and
procedures  contained  in  Article  12.

Our  policy  in  such  exceptional  circumstances  would  be  to  initiate  rule(cid:220)making  through  the  publication  of
an  Interim  Rule,  with  a  public  comment  period.  If  the  EC  can  demonstrate  that  the  disease  situation  was
brought  under  control  during  the  comment  period,  the  Interim  Rule  could  simply  be  withdrawn  and  the
normal  regionalization  provisions  apply,  i.e.,  the  United  States  would  accept  the  EC  regionalization
decision  without  further  action.

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I  hope  that  this  explanation  clarifies  our  position.  I  want  to  reiterate  that  we  understand  our  obligations
under  the  draft  agreement  with  respect  to  animal  health  and  the  recognition  of  regionalization  decisions,
and  intend  to  honor  those  commitments  in  every  respect.

I  believe  that  we  have  shown  considerable  understanding  of,  and  respect  for,  the  various  legal  requirements
which  the  EC  must  follow  in  the  implementation  of  its  obligations  under  the  draft  agreement.  We  too  have
certain  domestic  requirements  that  must  be  respected,  and  we  appreciate  your  consideration  in  helping  us
to  accomodate  those  requirements  as  we  implement  our  responsibilities.

Sincerely,

Terry  Medley

Administrator

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Official  Journal  of  the  European  Communities

1.5.98

ANNEX  III

January  28,  1998

Mr.  Paul  Drazek
USDA
Washington  D.C.

Dear  Paul,

Subject:  Forthcoming  Veterinary  Discussions:  MEGAREGs  and  BSE

Firstly,  I  would  like  to  thank  you  and  your  team  for  the  constructive  discussions  last  Friday.  It  was  most
helpful  to  be  able  to  run  over  the  ground,  and  will  enable  us  to  be  better  prepared  for  next  week’s
discussions  in  Washington.

You  asked  us  to  set  out  some  ideas  in  advance,  especially  as  regards  MEGAREGs.

On  the  MEGAREGs,  there  have  been  no  substantive  discussions  between  the  EC  and  the  U.S..  Indeed
although  we  had  some  discussion  last  year,  as  regards  the  SSOPs  and  E  coli  requirements,  the  provisions  as
regards  salmonella  and  HACCP,  which  apply  to  large  plants  from  January  1998,  were  not  really  discussed
as  we  all  expected  that  these  discussions  would  take  place  under  the  provisions  of  Footnote  1  to  Annex  V.

It  is  evident,  and  not  suprising,  that  EG  legislation  does  not  contain  exactly  the  same  provisions  as  those
the  U.S.  has  already  imposed,  and  will  progressively  impose  through  to  the  year  2000  for  the  production  of
red  meat  and  poultrymeat  under  the  MEGAREGs.  We  are  therefore  ready  to  consider  providing  a
guarantee  that  provisions  at  least  equivalent  to  those  set  down  in  the  MEGAREGs  are  applied  in  EC
establishments  which  are  to  be  listed  for  export  to  the  United  States,  or  establishments  that  supply  such
establishments.

We  therefore  propose  the  following:

All  red  meat  and  poultrymeat  establishments  exporting  to  the  United  States  must:

1.(cid:217)Be  EC  agreed  (oval  stamp)

2.(cid:217)(a)(cid:217)For  large  establishments  (more  than  500  employees):  apply  HACCP,  with  the  HACCP  plan
including  microbiological  testing  provisions  at  least  equivalent  to  those  set  down  in  the  MEGAREGs
for  E  coli  and  salmonella.

2.(cid:217)(b) For  other  establishments:  apply  SSOPs,  and  microbiological  testing  provisions  at  least  equivalent  to

those  set  down  in  the  MEGAREGs  for  E  coli.

3.(cid:217)The  U.S.  agrees  not  to  modify  the  provisions  as  regards  SSOPs,  HACCP,  E  coli  or  salmonella  testing,

as  they  stand  at  27  January  1998,  without  prior  discussion  with  the  EC.

4.(cid:217)A  procedure  be  agreed  to  initiate  discussions  immediately  to  compare,  on  a  case  by  case  basis,  the
testing  and  sampling  provisions  which  are  in  place  in  the  EC  or  which  are  proposed  with  those  set  down
in  the  MEGAREGs,  with  a  view  to  reaching  a  determination  of  equivalence.

This  approach  is  intended  to  provide  the  U.S.  with  clear  guarantees,  and  both  sides  with  a  process  through
which  alternative  testing  and  sampling  methodologies  may  be  assessed.  Point  3  is  simply  intended  to  ensure
that  this  work  can  move  forward  without  sudden  changes  being  applied  without  prior  notice.  It  does  not  of
course  prevent  the  U.S.  making  changes,  simply  calls  for  advance  discussion  with  the  EC.

Turning  to  BSE,  we  regret  that  we  had  no  possibility  of  advance  discussions  of  the  U.S.  concerns  that  led
to  the  action  on  12  December.  The  Commission  has  taken  a  considerable  number  of  measures  in  respect  of
BSE,  starting  in  1989  with  a  ban  on  the  movement  from  the  UK  to  other  Member  States  of  animals  born
before  1  July  1988  (the  date  on  which  the  UK  banned  the  feeding  of  ruminant  protein  to  ruminants)  or
animals  which  were  the  offspring  of  BSE  cases.  In  total,  23  Commission  Decisions  have  been  taken  on  the
subject.  These  include  measures  to  make  BSE  a  notifiable  disease,  to  require  certain  standards  of  treatment
for  waste  products,  to  ban  the  feeding  of  mammalian  protein  to  ruminants,  to  ban  the  export  to  other

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Member  States  or  third  countries  of  bovine  animals  and  certain  bovine  products  from  the  UK,  as  well  as  to
approve  BSE  control  and  eradication  programmes  in  the  UK,  France,  Ireland  and  Portugal.  It  should  be
noted  that  these  Member  States,  and  some  others,  have  SRM  bans  in  place.  The  Commission  actions  also
include  the  Decision  banning  the  use  of  specified  risk  materials  and  the  subsequent  Decision  postponing  its
entry  into  force  until  1  April  1998.  Details  of  these  Decisions  are  available  on  request.

The  Commission  has,  in  December,  set  up  an  interservice  group  to  make  an  evaluation  of  the  current  state
of  scientific  knowledge  on  specified  risk  materials,  and  to  recommend  future  action  to  the  Commission.
This  action  may  include  amending  the  current  SRM  Decision  (97/534/EC),  but  at  this  stage  it  is  not
possible  to  predict  the  content  of  any  such  amendment.

I  must  stress,  as  we  explained  during  the  meeting  in  Oxford,  that  the  purpose  of  the  SRM  Decision  is  to
address  risks  to  human  and  animal  health,  not  to  cover  "industrial’  products  which  do  not  present  a  health
hazard.  I  realise  that  the  wording  of  the  Decision  has  given  rise  to  concern  that  it  would  affect  industrial
products  imported  from  third  countries.  However,  the  certification  for  imports  is  only  required  for
products  of  animal  origin  intended  for  food  or  feed,  and  for  medicinal,  pharmaceutical  and  cosmetic
products  and  their  starting  materials  or  intermediate  products.  It  is  the  intention  of  the  Commission  to
clarify  the  scope  in  any  future  amendment  of  the  Decision  to  make  it  clear  that  "industrial’  products  are
excluded  from  the  requirements.

The  Commission’s  Scientific  Steering  Committee  met  last  week  to  address  the  question  of  SRMs,  and  in
particular  on  geographical  risk  factors  and  the  risks  associated  with  gelatin  and  tallow.  The  interservice
group  is  reflecting  on  the  outcome  from  the  Scientific  steering  Committee.

In  addition,  as  you  are  aware,  the  OIE  is  also  working  on  the  question  of  TSEs  at  present,  with  meetings
over  the  next  two  weeks  and  a  possible  decision  in  May.  The  outcome  of  this  work  will  also  have  a  bearing
on  the  Community  policy.

On  the  question  of  the  BSE  status  of  the  USA,  your  latest  submission  has  been  passed  to  DG  XXIV  with  a
request  for  it  to  be  examined  as  soon  as  possible  by  the  relevant  scientific  group.

As  far  as  your  "temporary  suspension’  of  import  licences  for  ruminants  and  ruminant  products  is
concerned,  we  intend  to  comment  in  the  coming  weeks,  on  behalf  of  the  Community,  on  the  interim  rule
published  in  the  Federal  Register  of  6  January.  At  this  stage,  I  would  not  wish  to  prejudge  the  Community
position,  but  I  would  query  the  restriction  of  the  scope  of  the  proposed  rule  to  Europe.  It  seems  to  me  that
many  countries  outside  Europe  have  the  same  risk  factors  which  you  cite  to  justify  your  current  import
prohibition  and  I  would  welcome  an  explanation  of  why  these  other  countries  are  not  subject  to  the  same
rule.

We  have  confirmed  our  travel  arrangements,  and  will  be  ready  to  start  work  on  the  morning  of  3  February
in  Washington.  We  look  forward  to  receiving  a  draft  agenda,  following  our  discussions  in  Brussels  on
23  January,  and  details  of  the  location  of  the  discussions.

Yours  sincerely

Lars  Hoelgaard

C  136/8

EN

Official  Journal  of  the  European  Communities

1.5.98

ANNEX  IV

March  3,  1998

Mr.  Guy  Legras
Director  General
Directorate(cid:220)General  VI
Commission  of  the  European  Community
Rue  de  la  Loi  200
B(cid:220)1049  Brussels

Dear  Mr.  Legras,

In  a  meeting  earlier  this  month  in  Washington,  EC  officials  requested  clarification  of  Food  Safety  and
Inspection  Service  (FSIS)  procedures  with  respect  to  the  implementation,  vis(cid:220)a(cid:220)vis  the  EC,  of  the  Pathogen
Reduction  Hazard  Analysis  Critical  Control  Point  Systems  (PR/HACCP)  rule.  This  letter  is  in  response  to
that  request.

First  of  all,  I  would  like  to  confirm  that  we  are  in  general  agreement  with  the  four(cid:220)point  approach  laid  out
in  Lars  Hoelgaard’s  letter  of  28  January  to  Paul  Drazek.  Further,  I  would  like  to  confirm  that

-(cid:217)FSIS,  in  keeping  with  U.S.  obligations  under  footnote  7  to  Annex  V  of  the  draft  agreement,  will
continue  to  recognize  decisions  by  the  veterinary  services  of  the  Member  States  to  add  and  delete
approved  export  establishments  from  their  list  of  establishments  exporting  to  the  United  States;

-(cid:217)FSIS  will  accept  HACCP  plans  developed  by  establishments,  provided  that  these  are  equivalent  to

U.S.  measures  and  are  under  official  control  and  supervision;  and

-(cid:217)FSIS  will  accept  Salmonella  testing  by  private  establishments,  provided  that  equivalent  regulatory
testing  for  verification  and  equivalent  regulatory  enforcement  is  carried  out  by  authorized  government
officials.

As  provided  for  in  footnote  1  to  Annex  V  of  the  draft  agreement  and  Mr.  Hoelgaard’s  letter,  FSIS  is
prepared  to  discuss  with  EC  and  Member  State  officials  in  the  coming  months  the  implementation  of
PR/HACCP  provisions  that  were  put  in  place  in  January  1998  -  i.(cid:216)e.,  HACCP  and  Salmonella
performance  standards  and  testing.  We  have  received  from  Member  States  notification  that  HACCP  and
Salmonella  standards,  or  equivalent  alternative  sanitary  measures,  are  in  place  in  those  establishments  that
have  500  or  more  employees  and  are  certified  to  export  to  the  United  States.  We  are  reviewing  those
submissions  in  accordance  with  the  principles  of  equivalence  and  will  make  every  effort  to  reach  a
successful  outcome.

The  situation 
is  somewhat  different  regarding  the  requirements  for  Sanitation  Standard  Operating
Procedures  (SSOPs)  and  Eshcheria  coli  (E.  coli)  testing,  which  were  implemented  in  January  1997.  With
respect  to  SSOPs,  FSIS  has  already  determined  that  all  EC  Member  States  have  complied  with  the
requirement,  or  have  implemented  equivalent  sanitary  measures,  in  establishments  which  are  certified  to
export  meat  or  poultry  to  the  United  States.

With  respect  to  E.  coli,  FSIS  has  approved  the  testing  programs  of  most  Member  States.  Discussions
continue,  however,  with  four  Member  States.  Since  more  than  a  year  has  elapsed  since  domestic  implemen(cid:220)
tation,  FSIS  must  now  proceed  in  the  coming  weeks  to  bring  the  process  to  closure.  If  FSIS  determines  that
the  original  and  follow(cid:220)up  documentation  and  information  provided  by  any  of  the  four  countries  does  not
demonstrate  that  a  proposed  alternative  sanitary  measure  is  equivalent  to  the  United  States’  E.  coli  testing
requirement,  FSIS  will  advise  that  country  and  the  Commission  of  its  determination.  That  country  will  then
be  allowed  sufficient  time  to  submit,  if  it  chooses  to  do  so,  additional  data  or  other  information  to  make  its
case.  Should  FSIS  still  judge  the  country’s  measures  not  to  be  equivalent  in  regards  to  E.  coli  testing,  the
Agency  must  proceed,  through  notice  and  comment  rule  making,  to  remove  the  country  from  the  group  of
countries  listed  in  the  United  States  Code  of  Federal  Regulations  as  eligible  to  export  meat  or  poultry  to
the  United  States.

Notwithstanding  the  above,  we  remain  open  to  initiating  general  follow(cid:220)on  discussions  on  E.  coli  testing
under  the  auspices  of  the  draft  agreement  and  point  4  of  Mr.  Hoelgaard’s  letter.  We  would  welcome  in
that  context  any  assistance  the  Commission  could  give  us  in  resolving  outstanding  issues.

1.5.98

EN

Official  Journal  of  the  European  Communities

C  136/9

I  can  confirm  that  FSIS  will  not  take  any  action  as  regards  the  PR/HACCP  requirements  against  any
Member  State  before  contacting  the  Commission  and  the  Member  States  concerned,  and  providing  an
opportunity  to  resolve  the  matter.

Let  me  assure  you  that  we  will  do  our  utmost  to  ensure  a  smooth  finalization  of  this  process  so  that  we  can
avoid  any  disruption  of  trade.

Sincerely,

Thomas  J.  Billy

Administrator

C  136/10

EN

Official  Journal  of  the  European  Communities

1.5.98

ANNEX  V

Mr.  Thomas  J.  Billy
Administrator
USDA/FSIS
Washington  D.C.  20250

Dear  Mr.  Billy,

Thank  you  for  your  letter  of  3  March  concerning  the  implementation  of  the  Pathogen  Reduction  Hazard
Analysis  Critical  Control  Point  Systems  (PR/HACCP).  The  letter  was  discussed  in  detail  by  the  Chief
Veterinary  Officers  of  the  Member  States  meeting  in  the  Council  on  5  March.

The  Commission  representative  was  asked  to  clarify  a  number  of  points  in  the  letter,  and  did  so  on  the
basis  of  the  conclusions  reached  in  our  meeting  in  Washington  at  the  beginning  of  February.  The  CVOs
concluded  by  asking  the  Commission  to  obtain  written  clarification  on  three  aspects  of  the  letter.

1.(cid:218)(cid:217)That  the  MEGAREG  rules  apply  only  to  those  EC  establishments  that  export  to  the  U.S.,  and  that
Member  States  were  not  obliged  to  enact  special  new  laws  to  put  such  arrangements  in  place.  I  would  be
grateful  for  your  confirmation  that  this  is  correct.

2.(cid:218)(cid:217)The  second  bullet  point  of  the  second  paragraph  states  that  FSIS  will  accept  HACCP  plans  provided
that  these  are  equivalent  to  US  measures  (emphasis  added).  In  this  context,  does  "measures’  refer  to  the  US
system  of  HACCP  in  general,  or  does  it  refer  to  more  specific  measures.

As  you  know,  EC  legislation  on  fresh  meat  and  poultry  meat  does  not  at  present  contain  requirements  for
HACCP,  although  it  is  the  intention  of  my  services  to  make  a  proposal  for  this  in  the  near  future.  The
proposal  will  be  based  on  the  full  CODEX  HACCP  system  (as  are  our  existing  HACCP  legislative
provisions  on  fishery  products  and  milk  and  dairy  products).  Until  this  is  adopted  in  legislation,  EC  firms
may  use  HACCP  on  a  voluntary  basis.  This  is  what  is  happening  in  firms  exporting  to  the  US  and  we  need
to  know  if  application  of  the  HACCP  system  as  described  by  CODEX  would  be  considered  "equivalent  to
US  measures’.

3.(cid:218)(cid:217)The  third  point  of  clarification  concerns  the  effect  of  the  last  four  paragraphs  of  your  letter  on  the
question  of  the  timing  of  actions  under  the  MEGAREG  as  discussed  in  Washington.

In  the  fourth  from  last  paragraph  you  state  that  FSIS  must,  in  the  coming  weeks,  bring  their  approval
process  to  closure  and,  if  they  judge  that  a  country’s  measures  are  not  equivalent,  they  must  delist  that
country.  However,  the  next  two  paragraphs  seem  to  indicate  that  the  US  would  not  delist  without  prior
consultation.  Furthermore,  your  final  paragraph  refers  to  avoiding  any  disruption  of  trade.

Member  States  asked  for  a  moratorium  from  the  US  so  that  no  Member  State  or  establishment  was
delisted  until  the  discussions  on  equivalency  have  taken  place.  Can  I  ask  you  to  confirm  that  this  de  facto
will  be  the  case  since  it  is  our  intention  that  these  equivalency  discussions  should  proceed  as  quickly  as
possible  and  the  penultimate  paragraph  of  your  letter  states  that  no  action  will  be  taken  before  an  oppor(cid:220)
tunity  has  been  provided  to  resolve  the  matter.

Yours  sincerely,

G.  Legras

1.5.98

EN

Official  Journal  of  the  European  Communities

C  136/11

ANNEX  VI

March  12,  1998

Mr.  Guy  Legras
Director(cid:220)General
Directorate(cid:220)General  VI,  Agriculture
European  Commission
Rue  de  la  Loi  200
B(cid:220)1049  Brussels

Dear  Mr.  Legras,

Thank  you  for  your  letter  of  March  6,  1998,  concerning  the  implementation  of  the  Pathogen  Reduction
Hazard  Analysis  Critical  Control  Point  Systems  (PR/HACCP)  rule.  We  appreciate  the  opportunity  to
clarify  three  points  in  our  letter  of  March  3,  1998.

1.(cid:218)(cid:217)We  concur  that  the  PR/HACCP  rule  applies  only  to  those  European  Community  (EC)  establishments
that  are  certified  to  export  to  the  United  States,  and  that  Member  States  are  not  obligated  to  enact  special
new  laws  to  put  such  arrangements  in  place.  A  circular  or  other  document  sent  from  the  Member  State  to
the  establishments  that  are  certified  to  export  to  the  United  States  would  be  an  acceptable  implementation
instrument.

2.(cid:218)(cid:217)We  concur  that  a  HACCP  system  as  described  by  Codex  Alimentarius  [see  Codex  Alimentarius,  Food
Hygiene  Basic  Texts,  Hazard  Analysis  and  Critical  Control  Point  (HACCP)  System  and  Guidelines  for  Its
Application,  Annex  to  CAC/RCP  1(cid:220)1969,  Rev.  3  (1997)(cid:129)  would  be  an  acceptable  sanitary  measure.  We
would,  of  course,  expect  that  the  HACCP  plan  address,  among  other  things,  certain  regulatory
requirements,  such  as  adequate  control  of  fecal  contamination  as  evidenced  by  E.  coli  testing  (or  an
equivalent  sanitary  measure),  zero  tolerance  for  visible  fecal  contamination,  pathogen  control  as  evidenced
by  the  Salmonella  standard  (or  an  equivalent  sanitary  measure),  etc.

In  accordance  with  CAC  HACCP  System  and  Guidelines  for  Its  Application,  we  would  expect  that  the
establishments  validate  and  verify  their  HACCP  plans.  We  would  also  expect  that  the  controlling  authority
enforce  this  requirement.

3.(cid:218)(cid:217)We  concur  that  prior  to  the  removal  of  a  Member  State  from  the  list  of  countries  eligible  to  export  to
the  United  States  the  Food  Safety  and  Inspection  Service  will  give  the  Member  State  an  opportunity  to
resolve  the  matter.  Before  proceeding,  through  notice  and  comment  rule  making,  to  remove  the  country
from  the  group  of  countries  listed  in  the  United  States  Code  of  Federal  Regulations  as  eligible  to  export
meat  or  poultry  to  the  United  States,  the  Member  State  and/or  the  Commission  acting  on  behalf  of  the
Member  State,  will  be  allowed  sufficient  time  to  submit;  if  it  chooses  to  do  so,  additional  data  or  other
information  to  make  its  case.  We  believe  this  objective,  transparent,  and  measured  process  offers  the
maximum  opportunity  to  finalize  the  remaining  equivalence  judgements  without  any  disruption  of  trade.
However,  we  cannot  agree  to  a  moratorium,  since  we  will  be  bringing  our  equivalence  approval  process  to
closure  in  the  coming  weeks  with  respect  to  the  implementation  of  the  Escherichia  coli  testing  provisions  of
the  PR/HACCP  final  rule.

Sincerely,

Thomas  J.  Billy

Administrator