(See emergency vaccination section)
 

 

 

 LATEST DRAFT PROPOSALS FOR

 

EU DIRECTIVE 25 MARCH 2003

 

(bold underlined text represents latest additions to draft)

 

 

 

Expert Group (Article 78 and Annex XVII)

 

N.B.

1) The Group should be permanently operational.  See 78.1

 

2) The Group is required to give advice in relation to emergency vaccination.  This is a new proposal.  See 78.3c

 

3) The reference to possible collaboration with other Member States, when referring (in the section on Contingency Plans) to the creation of an Expert Group.   This a new proposal.   See Annex XVII

Article 78

Expert Group

1.          Member States shall create a permanently operational expert group to maintain expertise in order to assist the competent authority in ensuring preparedness against an outbreak of foot-and-mouth disease.

By way of derogation from the first subparagraph, Member States with a limited number of animals of susceptible species may arrange a formalised agreement with other Member States on mutual assistance in regard of the expert group. These arrangements shall be detailed in the contingency plans referred to in Article 72.

2.           In case of a suspicion of an outbreak of foot-and-mouth disease the expert group shall at least:

(a) evaluate the clinical picture and the epidemiological situation;

(b)        give advice regarding the sampling and analyses needed for diagnosing the foot-and-mouth disease together with the additional actions and measures to be taken.

3.         In case of an outbreak of foot-and-mouth the expert group shall at least:

(a) conduct at least in the index case and if necessary on the spot, an evaluation of the clinical picture and an analysis of the epidemiological inquiry in order to collect the necessary data for determining the following:

(i) the origin of the infection;

(ii) the date of introduction of the infectious agent;

(iii) the possible spread of the disease.

(b) report to the Chief Veterinary Officer and the national disease control centre;

(c) give advice on screening, sampling, test procedures, control and the other measures to be applied and on the strategy to be implemented, including advice on bio-security measures on holdings or on premises referred to in Article 16, and in relation to emergency vaccination

(d) follow up and guide the epidemiological inquiry;

(e) supplement the epidemiological data with geographical, meteorological and other necessary information;

(f) analyse the epidemiological information and perform risk assessments at regular intervals;

(g) assist in ensuring that the disposal of animal carcasses and animal waste is done with a minimum of detrimental effect on the environment.

 

Appendix XVII

7.           A permanently operational expert group shall be created, where necessary in collaboration with other Member States, to maintain expertise and assist the relevant authority in qualitative disease preparedness.

 

 

 

Expertise  Epidemiological Inquiry Article 13

 

N.B.

The requirement for specifically trained veterinarians to carry out the epidemiological inquiries in relation to outbreaks.

 

Article 13

Epidemiological inquiry

1.          Member States shall ensure that epidemiological inquiries in relation to outbreaks of foot-and-mouth disease are carried out by specifically trained veterinarians on the basis of questionnaires, prepared within the framework of the contingency plans provided for in Article 72, to ensure standardised, speedy and targeted inquiries. Such inquiries shall deal at least with:

(a) the length of time during which the foot-and-mouth disease may have been present on a holding before being suspected or notified;

(b) the possible origin of the foot-and-mouth disease virus on a holding and the identification of other holdings where there are animals suspected of being infected or animals suspected of being contaminated from the same source;

(c) the possible extent to which animals of susceptible species other than bovine and porcine animals may have been infected or contaminated;

(d) the movement of animals, persons, vehicles and the substances referred to in Article 4 (3) (c) likely to have carried the foot-and-mouth disease virus to or from the holdings in question.

2.          Member States shall inform and regularly update the Commission and the other Member States about the epidemiology and spread of the foot-and-mouth disease virus.

 

 

 

Contingency Plans  Annex XVII

 

N.B.

1) The role of the expert group, and collaboration with other Member States.

2) Detailed emergency vaccination plans required.

3) Specialised and regular training required for staff.

4) “Real time alert exercises” two times in 5 years, etc

Annex XVII (Criteria and requirements for contingency plans)

7.           A permanently operational expert group shall be created, where necessary in collaboration with other Member States, to maintain expertise and assist the relevant authority in qualitative disease preparedness.

10.          Detailed plans shall be available for emergency vaccination.

11.         Staff shall be regularly involved in:

11.1.          training in clinical signs, epidemiological enquiry and control of epizootic diseases, 11.2.          real‑ time alert exercises, conducted as follows:

11.2.1.   two times within a five years period, or

11.2.2.          during the five years period an outbreak of a major epizootic disease has been effectively controlled and eradicated, or

11.2.3.   one of the two exercises referred to in paragraph 11.2.1. is replaced by a real-time exercise required within the framework of contingency plans for other major epidemic diseases affecting terrestrial animals, or

11.2.4.   by way of derogation from paragraph 11.2.1. and subject to appropriate provisions in the contingency plan, Member States with a limited population of animals of susceptible species arrange for the participation in and contribution to real-time exercises carried out in a neighbouring Member States and alarm-drills are carried out as provided for in paragraph (g) (ii) of Annex VII of Directive 2001/89 in relation to all animals of species susceptible to foot-and-mouth disease.

 

___________________________________________________________________

 

 

Emergency vaccination  Sections 8 to 14 (Articles 49 to 84) Annex X

 Annex XVII

 

N.B.

1) Article 50 details condition(s) which must apply if emergency vaccination is to be introduced (at least one must apply).  The decisions to vaccinate must take into account Article 15 (Measures to be applied in special cases e.g. zoos) and Annex X (table of criteria).  There are many important new criteria regarding implementing vaccination in this latest draft e.g. relative costs of strategies, social and psychological effects,. if forseeable that 24/48 hour rule of infected and contaminated premises will not be met, if large intensive livestock production units present.  

Annex X

 

2) Requirement for detailed emergency vaccination plans.  Annex XVII (See above)

 

3) Requirement to prepare to implement emergency vaccination in surveillance zone immediately the outbreak occurs (as detailed in the emergency vaccination plans already drawn up).  Article 14.3

 

4) See Section 50.6  This is new clause allowing EU initiative to introduce emergency vaccination in consultation with Member State, if certain conditions apply ( if disease threatens to become widespread and if represents threat to other Member States re geography and meterological conditions.)

 

5) In Note 15 listed under “Whereas” at the beginning of the Draft Directive, it is interesting to note that disease control measures within an individual Member State “should also be reinforced by specific protection measures established in accordance with Community legislation”.  I think this could place further pressure on Defra not to be blinkered as regards pursuing a mass killing policy i.e. there are other protection measures which Defra has a duty to consider e.g. emergency vaccination.

 

6) In Article 88 authorisation for ad hoc disease control measures is given “to implement alternative measures with equivalent epidemiological effect”.

I am not sure how to interpret this, as I have not had time to check the Articles referred to in article 88 i.e. Articles 5 and 7 Decision 1999/468/EC (See below).

 

 

Article 50

Decision on introducing emergency vaccination

1.           It may be decided to introduce emergency vaccination where at least one of the following conditions applies:

(a) outbreaks of foot-and-mouth disease have been confirmed and threaten to become widespread in the Member State where such outbreaks have been confirmed;

(b) other Member States are at risk due to the geographical situation of or the prevailing meteorological conditions in relation to reported outbreaks of foot-and-mouth disease in a Member State;

(c) other Member States are at risk due to epidemiologically relevant contacts between holdings on their territories and holdings keeping animals of susceptible species in a Member States where there are outbreaks of foot-and-mouth disease;

(d) Member States are at risk due to the geographical situation or the prevailing meteorological conditions in a neighbouring third country where there are outbreaks of foot-and-mouth disease;

2.           When deciding on the introduction of emergency vaccination, consideration shall be given to the measures provided for in Article 15 and to the criteria listed in Annex X.

3.           The decision to introduce emergency vaccination shall be adopted in accordance with the procedure referred to in Article 89 (3), either on request of the Member State directly affected or at risk.

4.           By way of derogation from paragraph 3, the decision to introduce emergency vaccination may be taken by the Member State concerned and implemented in accordance with this Directive, after a written notification to the Commission which shall include the specifications provided for in Article 51.

5.           If a Member State introduces emergency vaccination in accordance with paragraph 4, that decision shall be immediately reviewed in the Standing Committee on the Food Chain and Animal Health and Community measures shall be adopted in accordance with the procedure referred to in Article 89 (3).

6.           By way of derogation from paragraph 3, a decision to introduce emergency vaccination in a Member State referred to in paragraph (1) (a) may be adopted in consultation with the affected Member State in accordance with the procedure referred to in Article 89 (3) on the Commission's own initiative, if the condition in paragraph (1) (a) and paragraph (1) (b) apply.

 

 

 

 

ANNEX X

Criteria for the decision to apply protective vaccination
and guidelines for the emergency vaccination programmes

1.          Criteria for the decision to apply protective vaccination*

Criteria

Decision

 

For vaccination

Against vaccination

Population density of
susceptible animals

High

Low

Predominant species clinically affected

pigs

ruminants

Movement of potentially infected animals or products out of the protection zone

Evidence

No evidence

Predicted airborne spread of virus from infected holdings

High

Low or absent

Suitable vaccine

Available

Not available

Origin of outbreaks (traceability)

Unknown

Known

Incidence slope of outbreaks

Rising rapidly

Shallow or slow rise

Distribution of outbreaks

Widespread

Restricted

Public reaction to total stamping out policy

Strong

Weak

Acceptance of regionalisation after vaccination

Yes

No

* = in accordance with the report of the Scientific Committee on Animal Health 1999

2.            additional criteria for the Decision to introduce emergency vaccination

Criteria

Decision

 

For vaccination

Against vaccination

Acceptance of regionalisation by third countries

known

unknown

Economic assessment of competing control strategies

If it is foreseable that a control strategy without emergency vaccination would lead to significantly higher economic losses in the agricultural and non agricultural sectors

If it is foreseable that a control strategy with emergency vaccination would lead to significantly higher economic losses in the agricultural and non agricultural sectors

It is foreseable that the 24/48 hours rule cannot be implemented effectively for two consecutive days (1)

Yes

No

Significant social and psychological impact of total stamping out policy

Yes

No

Existence of large holdings of intensive livestock production

Yes

No

 

(1)        24/48 hours rule means:

(a)           infected herds on holdings referred to in Article 10 cannot be stamped out within 24 hours after the confirmation of the disease, and

(b)           the pre-emptive killing of animals likely to be infected or contaminated cannot be safely carried out within less than 48 hours.

3.            Criteria for the definition of Densely Populated Livestock Areas

              When deciding about the measures to be taken in application of this Directive, and in particular the measures provided for in Article 52 (2), Member States shall in addition to a thorough epidemiological assessment consider the provisional definitions of densely populated livestock areas (DPLA) for the relevant species of susceptible animals predominantly kept in the area in question and use the definition which is the more stringent.

              The provisional definition may be modified in the light of new scientific evidence in accordance with the procedure referred to in Article 89 (2).

3.1.          Porcine animals:

              In the case of pigs a DPLA is a geographical area with a radius of 10 km around a holding containing susceptible animals suspected of or infected with foot-and-mouth disease, where there is a pig density higher than 800 pigs per km2. The holding in question must be situated either in a sub-region as defined in Article 2 (s) where there is a density of pigs higher than 300 pigs per km2 or at a distance of less than 20 km from such a sub-region.

3.2.          Animals of susceptible species :

              In the case of animals of susceptible species a DPLA is a geographical area, an area complying with the conditions in 3.1 or  an area with a radius of 10 km around a holding containing susceptible animals suspected of or infected with foot‑and‑mouth disease, where there is a density of animals of susceptible species higher than 1000 head per km2. The holding in question must be situated either in a sub-region as defined in Article 2 (s) where there is a density of animals of susceptible species  higher than 450 head per km2 or at a distance of less than 20 km from such a sub-region.

 

 

Article 14

Additional measures in case of confirmation of outbreaks of foot-and-mouth disease

 

3.           The competent authority shall immediately upon the confirmation of the first outbreak of foot-and-mouth disease prepare all arrangements deemed necessary for emergency vaccination in an area of at least the size of the surveillance zone established in accordance with Article 21.

 

Excerpt from beginning of DD:  “Whereas” No 15:

                         It is necessary that action be taken as soon as the presence of the foot-and-mouth disease is suspected so that immediate and effective control measures can be implemented once its presence is confirmed. Such measures should be modulated by the competent authorities depending on the epidemiological situation in the Member State concerned. However, such measures should also be reinforced by specific protection measures established in accordance with Community legislation.

 

 

Article 50

Decision on introducing emergency vaccination

1.           It may be decided to introduce emergency vaccination where at least one of the following conditions applies:

(a) outbreaks of foot-and-mouth disease have been confirmed and threaten to become widespread in the Member State where such outbreaks have been confirmed;

(b) other Member States are at risk due to the geographical situation of or the prevailing meteorological conditions in relation to reported outbreaks of foot-and-mouth disease in a Member State;

(c) other Member States are at risk due to epidemiologically relevant contacts between holdings on their territories and holdings keeping animals of susceptible species in a Member States where there are outbreaks of foot-and-mouth disease;

(d) Member States are at risk due to the geographical situation or the prevailing meteorological conditions in a neighbouring third country where there are outbreaks of foot-and-mouth disease;

2.           When deciding on the introduction of emergency vaccination, consideration shall be given to the measures provided for in Article 15 and to the criteria listed in Annex X.

3.           The decision to introduce emergency vaccination shall be adopted in accordance with the procedure referred to in Article 89 (3), either on request of the Member State directly affected or at risk.

4.           By way of derogation from paragraph 3, the decision to introduce emergency vaccination may be taken by the Member State concerned and implemented in accordance with this Directive, after a written notification to the Commission which shall include the specifications provided for in Article 51.

5.           If a Member State introduces emergency vaccination in accordance with paragraph 4, that decision shall be immediately reviewed in the Standing Committee on the Food Chain and Animal Health and Community measures shall be adopted in accordance with the procedure referred to in Article 89 (3).

6.           By way of derogation from paragraph 3, a decision to introduce emergency vaccination in a Member State referred to in paragraph (1) (a) may be adopted in consultation with the affected Member State in accordance with the procedure referred to in Article 89 (3) on the Commission's own initiative, if the condition in paragraph (1) (a) and paragraph (1) (b) apply.

 

 

 

Article 88

Procedure for the adoption of ad hoc epidemiological measures

 

Where, in implementing the measures provided for by this Directive, a Member State determines that a measure is not adapted to the epidemiological situation, or where the foot-and-mouth disease virus appears to be spreading despite the measures taken in accordance with this Directive, a Decision may be adopted on an ad hoc basis in accordance with the procedure referred to in Article 89 (3) to authorise that Member State to implement alternative measures with equivalent epidemiological effect for a limited period of time appropriate to the epidemiological situation.

 

Article 89

3.          Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply and the period referred to in Article 5 (6) of that Decision shall be 15 days.