Control of Xylella fastidiosa (Wells et al.) Regulations, 2017

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 19,898, 10 ta’ Novembru, 2017

L.N. 315 of 2017

PLANT QUARANTINE ACT

(CAP. 433)

Control of Xylella fastidiosa (Wells et al.) Regulations, 2017

IN exercise of the powers conferred by article 32 of the Plant

Quarantine Act, the Minister for the Environment, Sustainable

Development and Climate Change has made the following

regulations:-

(1) The title of these regulations is the Control of Citation and

scope.

Xylella fastidiosa (Wells et al.) Regulations, 2017.

(2) These regulations provide the measures to be taken to

control and contain Xylella fastidiosa and to prevent it from spreading

and the implementation of Commission Implementing Decision (EU)

2015/789 of 18 May 2015 as regards measures to prevent the

introduction into and the spread within the Union of Xylella fastidiosa

(Wells et al.) and its amendments.

In these regulations, unless the context otherwise requires

Interpretation.

"the Act" means the Plant Quarantine Act;

"the Commission" means the Commission of the European

Union;

"the Directorate" means the Directorate responsible for plant

health;

"the Director" means the Director responsible for plant health;

"host plants" means plants for planting, other than seeds,

belonging to the genera and species listed in the Commission

database of host plants susceptible to Xylella fastidiosa in the Union

territory, as having been found to be susceptible in the Union territory

to the specified organism or, where a Member State has demarcated

an area with regard to only one or more subspecies of the specified

organism pursuant to the proviso to regulation 6(1), as having been

found to be susceptible to that or those subspecies;

"the Minister" means the Minister responsible for agriculture;

"professional operator" means any person involved

professionally in one or more of the following activities concerning

plants

(a)

planting;

(b)

breeding;

(c)

production, including growing, multiplying and

maintaining;

(d) introduction into, and movement within, and out of

the Union territory;

(e)

making available on the market;

"the specified organism" means any subspecies of Xylella

fastidiosa (Wells et al.);

"specified plants" means host plants and all plants for planting,

other than seeds, belonging to the genera or species included in the

list of plants known to be susceptible to the European and non-

European isolates of the pest as published in the Government Gazette

and the Directorate’s website and which is updated accordingly from

time to time;

"the Union” means the European Union.

(1) Any person who suspects or becomes aware of the

specified organism shall immediately inform the Directorate and

provide it with all relevant information concerning the presence, or

suspected presence, of the specified organism.

(2) The

Directorate

shall

immediately

record

such

information.

(3) Where the Directorate has been informed of a presence, or

suspected presence, of the specified organism it shall take all

necessary measures to confirm that presence, or the suspected

presence.

(4) The Directorate shall ensure that any person having under

his control plants which may be infected with the specified organism

is immediately informed of the suspected presence of the specified

organism, of the possible consequences and risks and of the measures

to be taken.

(1) The Directorate shall conduct annual surveys for the

presence of the specified organism on the specified plants. Those

surveys may be carried out under official supervision of the

Directorate. They shall consist of visual examinations and, in the case

of any suspicion of infection by the specified organism, collection of

samples and testing. Those surveys shall be based on sound scientific

and technical principles and shall be carried out at appropriate times

of the year with regards to the possibility to detect the specified

organism. Those surveys shall take account of the available scientific

and technical evidence, the biology of specified organism and its

vectors, the presence and biology of specified plants, and any other

appropriate information concerning the presence of the specified

organism.

(2) The Director may request the placement of traps for the

monitoring of the presence of the vector and which shall be collected

by the Directorate from time to time for such determination..

(1) The Directorate shall establish a plan setting out the Contingency

actions to be taken in its territory in accordance with regulations 5 to plans.

8 and regulations 10 to 14 in case of a confirmed or suspected

presence of the specified organism (hereinafter “the contingency

plan”).

(2) The contingency plan shall also set out the following

(a)

the roles and responsibilities of the bodies involved

in those actions and the single authority;

(b) one or more laboratories specifically approved for

the testing of the specified organism;

(c)

rules on the communication of those actions

between the bodies involved, the single authority, the

professional operators concerned and the public;

(d) protocols describing the methods

of

visual

examinations, sampling and laboratory testing;

(e)

rules on training of personnel of the bodies involved

in those actions;

(f)

minimum resources to be made available and

proceedings to make available additional resources in case of a

confirmed or suspected presence of the specified organism.

(3) The Directorate shall evaluate and review the contingency

plans as necessary.

(4) The Directorate shall communicate the contingency plans to

the Commission at its request.

(1) Where the presence of the specified organism is

confirmed, the Directorate shall without delay demarcate an area,

hereinafter referred to as a "demarcated area", in accordance with

sub-regulation (2)

Provided that where the presence of one or more particular

subspecies of the specified organism is confirmed, the Directorate

may demarcate an area with regard to that or those subspecies only.

(2) The demarcated area shall consist of an infected zone and a

buffer zone.

(a)

The infected zone shall include all plants known to

be infected by the specified organism, all plants showing

symptoms indicating possible infection by that organism, and

all other plants liable to be infected by that organism due to their

close proximity to infected plants, or common source of

production, if known, with infected plants, or plants grown from

them.

(b) The buffer zone shall be of a width of at least 10km,

surrounding the infected zone.

The exact delimitation of the zones shall be based on sound

scientific principles, the biology of the specified organism and its

vectors, the level of infection, the presence of the vectors and the

distribution of specified plants in the area concerned.

(3) If the presence of the specified organism is confirmed in

the buffer zone, the delimitation of the infected zone and buffer zone

shall immediately be reviewed and changed accordingly.

(4) If the Directorate confirms the presence of the specified

organism and is notified in accordance with EU legislation, it shall

communicate the demarcated area to the Commission.

(5) Where, based on the surveys which the Directorate

performs on the specified organism as in regulation 4 and on the

monitoring referred to in regulation 8(7), the specified organism is

not detected in a demarcated area for a period of five years, this

demarcation may be lifted. In such cases, the Directorate shall notify

the Commission and other Member States.

(6) Notwithstanding the provisions of sub-regulation (1), the

Directorate may decide not to establish a demarcated area

immediately where all of the following conditions are fulfilled

(a)

there is evidence that the specified organism was

recently introduced into the area with the plants on which it was

found;

(b) there is an indication that those plants were infected

before their introduction into the area concerned;

(c)

no vectors carrying the specified organism have

been detected, on the basis of tests carried out in accordance

with internationally validated testing methods, in the vicinity of

those plants.

(7) In the case referred to in sub-regulation (6), the Directorate

shall

(a)

carry out an annual survey for at least two years to

determine whether any plants, other than those on which the

specified organism was first found to be present, have been

infected;

(b) on the basis of that survey, determine whether there

is a need to establish a demarcated area;

(c)

notify to the Commission and the other Member

States the justification for not establishing a demarcated area,

and the outcome of the survey referred to in paragraph (a) as

soon as they become available.

(1) The planting of host plants in infected zones shall be Prohibition

prohibited, except in sites which are physically protected against the concerning

planting of host

introduction of the specified organism by its vectors.

plants in

infected zones.

(2) Notwithstanding the provisions of sub-regulation (1), the

Directorate may authorise, in accordance with the conditions laid

down in regulation 20 of Plant Quarantine (Harmful Organisms) S.L. 433.03.

Regulations, the planting of the host plants for scientific purposes

within the containment area referred to in regulation 9, outside the

area referred to in regulation 9(2)(c).

(1) The Directorate, having established the demarcated Eradication

area referred to in regulation 6, shall take in that area the measures set measures.

out in this regulation.

(2) The Directorate shall, within a radius of 100m around the

plants which have been tested and found to be infected by the

specified organism, immediately remove

(a)

host plants, regardless of their health status;

(b) plants known to be infected by the specified

organism;

(c)

plants showing symptoms indicating possible

infection by the specified organism or suspected to be infected

by that organism.

(3) The Directorate shall sample and test the specified plants

within a radius of 100m around each of the infected plants, in

accordance with the International Standard for Phytosanitary

Measures ISPM No 31 - Methodologies of sampling of consignments.

(4) The Directorate shall carry out appropriate phytosanitary

treatments prior to the removal of plants referred to in sub-regulation

(2) against the vectors of the specified organism and plants that may

host those vectors.

(5) The Directorate shall, in situ, or in a nearby location

designated for this purpose within the infected zone, destroy the

plants and parts of plants referred to in sub-regulation (2), in a

manner ensuring that the specified organism is not spread.

(6) The Directorate shall carry out appropriate investigations

to identify the origin of the infection and shall trace the specified

plants associated with the case of infection concerned, including

those which were moved before a demarcated area was established.

The results of such investigations shall be communicated to Member

States in which those plants concerned originate, to the Member

States through which those plants have moved and to the Member

States where those plants have moved into.

(7) The Directorate shall monitor the presence of the specified

organism by annual surveys at appropriate times and shall carry out

visual inspections of the specified plants and sample and test

symptomatic plants, as well as asymptomatic plants in the proximity

of the symptomatic ones.

In buffer zones, the surveyed area shall be based on a grid

split into 100m × 100m squares and visual inspections shall take

place in each of those squares.

(8) The Directorate shall raise public awareness concerning

the threat of the specified organism and concerning the measures

adopted to prevent its introduction into and spread within the Union

and shall set up road signs indicating the delimitation of the

respective demarcated area.

(9) The Directorate shall, where necessary, take measures

addressing any particularity or complication that could reasonably be

expected to prevent, hinder or delay eradication, in particular those

related to the accessibility and adequate destruction of all plants that

are infected or suspected of infection, irrespective of their location,

public or private ownership or the person or entity responsible for

them.

(10) The Directorate shall take any other measure, which may

contribute to the eradication of the specified organism, in accordance

with ISPM No 9 - Guidelines for pest eradication programmes and

applying an integrated approach in accordance with the principles set

out in ISPM No 14 - The use of integrated measures in a systems

approach for pest risk management.

(11) The Directorate shall apply appropriate agricultural

practices for the management of the specified organism and its

vectors.

(1) Notwithstanding the provisions of regulation 8, only Containment

in the infected zone referred to in regulation 6(2), the Director may areas.

decide to apply containment measures, as set out in sub-regulations

(2) to (7), hereinafter referred to as "containment areas".

(2) The Director shall immediately authorise the removal of at

least all plants which have been found to be infected by the specified

organism if they are situated in any of the following locations

(a)

in the proximity of the sites referred to in regulation

10(2);

(b) in the proximity of the sites of plants with particular

cultural, social or scientific value;

(c)

a location within the infected zone referred to in

regulation 6(2), situated within a distance of 20km from the

border of that infected zone with the rest of the Union territory.

All necessary precautions shall be taken to avoid spreading

of the specified organism during and after removal.

(3) The Director shall order, within a radius of 100m around

the plants referred to in sub-regulation (2) and which have been found

to be infected by the specified organism, the sampling and testing of

the host plants, in accordance with the International Standard for

Phytosanitary Measures ISPM No. 31. That testing shall be carried

out at regular intervals and at least, twice a year.

(4) The Director shall order that appropriate phytosanitary

treatments are applied prior to the removal of plants referred to in

sub-regulation (2) against the vectors of the specified organism and

plants that may host those vectors. Those treatments may include, as

appropriate, removal of plants.

(5) The Director shall order that, in situ or in a nearby location

designated for this purpose within the containment area, the plants

and parts of plants referred to in sub-regulation (2) are destroyed in a

manner ensuring that the specified organism is not spread.

(6) The Director shall order that appropriate agricultural

practices are applied for the management of the specified organism

and its vectors.

(7) The Directorate shall monitor the presence of the specified

organism by annual surveys at appropriate times during the year in

the areas situated within the distance of 20 km as referred to in

paragraph (c) of sub-regulation (2). Those surveys shall be carried out

in accordance with the provisions of regulation 8(7).

(1) This regulation shall apply to specified plants, other

than plants which have been grown for the entire production cycle in

vitro.

The movement out of the demarcated areas and from the

infected zones into the respective buffer zones, of specified plants

which have been grown for at least part of their life in a demarcated

area established in accordance with regulation 6, shall be prohibited.

(2) Notwithstanding the provisions of sub-regulation (1), such

movement can take place if the specified plants have been grown in a

site where all of the following conditions are fulfilled

(a)

it is registered in accordance with the Plant

Quarantine (Harmful Organisms) Regulations;

(b) it is authorised by the Directorate as a site free from

the specified organism and its vectors, taking into account the

relevant International Standards for Phytosanitary Measures;

(c)

it is physically protected against the introduction of

the specified organism by its vectors;

(d) it is surrounded by a zone with a width of 200m

which has been found by official visual inspection and, in the

case of suspected presence of the specified organism, by

sampling and testing, to be free from the specified organism,

and is subject to appropriate phytosanitary treatments against

the vectors of the specified organism; those treatments may

include, as appropriate, removal of plants;

(e)

it is subject to appropriate phytosanitary treatments

to maintain freedom from vectors of the specified organism;

those treatments may include, as appropriate, removal of plants;

(f)

it is subjected annually, together with the zone

referred to in paragraph (d), to at least two official inspections

carried out at appropriate times;

(g) throughout the time of growth of the specified

plants, neither symptoms of the specified organism nor its

vectors were found in the site or, if suspect symptoms were

observed, tests carried out confirmed the absence of the

specified organism;

(h) throughout the time of growth of the specified

plants, no symptoms of the specified organism were found in

the zone referred to in paragraph (d) or, if suspect symptoms

were observed, testing has been undertaken and absence of the

specified organism has been confirmed.

(3) Representative samples of each species of specified plants

from each site have been subject to annual testing, at the most

appropriate time, and the absence of the specified organism has been

confirmed on the basis of tests carried out in accordance with

internationally validated testing methods;

(4) As practically close to the time of movement as possible

the lots of the specified plants were subjected to official visual

inspection, sampling and molecular testing carried out in accordance

with internationally validated testing methods, using a sampling

scheme able to identify with 99% reliability a level of presence of

infected plants of 1% or above and targeted especially at plants

displaying suspect symptoms of the specified organism, in

accordance with ISPM No 31.

(5) Notwithstanding the provisions of sub-regulations (1) and

(4), the movement within the Union, within or out of demarcated

areas, of dormant plants of Vitis intended for planting, other than

seeds, may take place if both of the following conditions are fulfilled

(a)

the plants have been grown in a site registered in

accordance with the Plant Quarantine (Harmful Organisms)

Regulations;

(b) as practically close to the time of movement as

possible, the plants have undergone an appropriate

thermotherapy treatment in a treatment facility authorised and

supervised by the Directorate for that purpose, whereby the

dormant plants are submerged for 45 minutes in water heated to

50 degrees Celsius, in accordance with the relevant EPPO

standard (Hot water treatment of grapevine to control Grapevine

flavescence dorée phytoplasma).

(6) Prior to movement, the lots of the specified plants were

subjected to phytosanitary treatments against any of the vectors of the

specified organism.

(7) Specified plants moving through or within demarcated

areas shall be transported in closed containers or packaging, ensuring

that infection with the specified organism or any of its vectors cannot

occur.

(8) All plants referred to in sub-regulation (1) shall only be

moved to and within the Union territory if they are accompanied by a

plant passport prepared and issued in accordance with regulation 8 of

the Plant Quarantine (Harmful Organisms) Regulations.

(9) Host plants which have never been grown inside the

demarcated areas shall only be moved within the Union if they are

accompanied by a plant passport prepared and issued in accordance

with the Standardization and Issue Procedures of Plant Passports

Regulations

Provided that, without prejudice to Part A of Schedule V of

the Plant Quarantine (Harmful Organisms) Regulations, no plant

passport shall be required for the movement of host plants to any

person, acting for purposes which are outside his trade, business or

profession, and who acquires those plants for his own use.

(1) Specified plants which have been grown for the

entire production cycle in vitro and for at least part of their life in a

demarcated area established in accordance with regulation 6, may

only be moved out of the demarcated areas and from the infected

zones into the respective buffer zones if the conditions set out in sub-

regulations (2) to (5) are fulfilled.

(2) The specified plants referred to in sub-regulation (1) have

been grown in a site where all of the following conditions are

fulfilled

(a)

it is registered in accordance with the Plant

Quarantine (Harmful Organisms) Regulations;

(b) it is authorised by the Directorate as a site free from

the specified organism and its vectors, taking into account the

relevant International Standards for Phytosanitary Measures;

(c)

it is physically protected against the introduction of

the specified organism by its vectors;

(d)

it is subjected annually to at least two official

inspections carried out at appropriate times;

(e)

throughout the time of growth of the specified

plants, neither symptoms of the specified organism nor its

vectors were found in the site or, if suspect symptoms were

observed, tests carried out confirmed the absence of the

specified organism.

(3) The specified plants referred to in sub-regulation (1) have

been grown in a transparent container under sterile conditions and

fulfil one of the following conditions

(a)

they have been grown from seeds;

(b)

they have been propagated, under sterile conditions,

from mother plants which have spent their entire lives in an area

of the Union territory free from the specified organism and

which have been tested and found free from the specified

organism;

(c) they have been propagated, under sterile conditions,

from mother plants which have been grown in a site fulfilling

the conditions set out in sub-regulation (2) and which have been

tested and found free from the specified organism.

(4) The specified plants referred to in sub-regulation (1) shall

be transported in a transparent container under sterile conditions that

precludes the possibility of infection by the specified organism

through its vectors.

(5) They shall be accompanied by a plant passport prepared and

issued in accordance with the Standardization and Issue Procedures

of Plant Passports Regulations.

(1) Professional operators supplying specified plants Traceability.

which have been grown for at least part of their lives in a demarcated

area, or which have been moved through such an area, shall keep a

record of each lot supplied and of the professional operator who

received it.

(2) Professional operators being supplied with specified plants

which have been grown for at least part of their life in a demarcated

area, or which have been moved through such an area, shall keep a

record of each lot received and of the supplier.

(3) Professional operators shall keep the records referred to in

sub-regulations (1) and (2) for a minimum period of three years from

the date on which the respective lot was supplied to or by them.

(4) The professional operators referred to in sub-regulations

(1) and (2) shall inform the Directorate forty-eight hours prior to the

arrival of the plant material in Malta, by means of the EU Plant

Movement Notification form available on the Directorate’s website,

of each lot supplied or received by them. That information shall

include the origin, consigner, consignee, place of destination,

individual serial, week or batch number of the plant passport and

identity and quantity of the lot concerned.

(5) The Directorate receiving information pursuant to sub-

regulation (4) shall immediately inform the responsible official body

of the place of destination of the lot concerned.

(6) The professional operators being supplied from Union

territories with specified plants which have been grown in non-

demarcated areas, or which have not been moved in such areas shall

also inform the Directorate by means of the EU Plant Movement

Notification form available on the Directorate’s website forty-eight

hours prior to the arrival of the plant material in Malta.

(7) The professional operator being supplied with specified

plants referred to in sub-regulation (6) shall keep a record of each lot

received and, or supplied to other professional operator/s. The records

shall include the notification form, all invoices and accompanying

documents (delivery notes or receipts), plant passports in accordance

with the Standardization and Issue Procedures of Plant Passports

Regulations where applicable.

(8) The Directorate shall, upon request, make available the

information referred to in sub-regulation (4) to the Commission.

(1) The Directorate shall carry out regular official

checks on specified plants being moved out of a demarcated area, or

from an infected zone to a buffer zone. Such checks shall be

performed at least in

(a)

the points where the specified plants are moved

from infected zones into buffer zones;

(b) the points where the specified plants are moved

from buffer zones into non-demarcated areas;

(c)

the place of destination of the specified plants in the

buffer zone;

(d)

the place of destination in the non-demarcated areas.

(2) The checks as referred to in sub-regulation (1) shall

include a documentary check, and an identity check of the specified

plants.

The checks as referred to in sub-regulation (1) shall be

carried out irrespective of the location of the specified plants,

ownership or the person or entity responsible for them.

(3) The intensity of the checks referred to in sub-regulation (2)

shall be based on the risk that the plants carry the specified organism

or the known or potential vectors, taking into account the provenance

of the lots, the degree of susceptibility of the plants, and the

compliance by the professional operator responsible for the

movement with these regulations and with any other measure taken to

contain or eradicate the specified organism or any other factor

considered relevant by the Directorate.

The Director shall establish and update a list of all sites List of

authorised in accordance with regulation 10(2). The Director shall authorised sites.

submit that list to the Commission. On the basis of the information

received from the Member States, the Commission shall establish and

update a list of all sites authorised in the Member States. The

Commission shall transmit that list to any Member State.

Where the checks referred to in regulation 13(2) show that Measures in

the conditions laid down in regulation 10 are not satisfied, the case

compliance with

Director shall immediately destroy the non-compliant plant in situ or regulation 10.

in a nearby location. That action shall be carried out taking all

necessary precautions to avoid spreading of the specified organism,

and any vectors carried by that plant, during and after removal.

The introduction into the Maltese territory of plants for Prohibition of

planting, other than seeds, of Coffea originating in Costa Rica or the

of plants for

Honduras shall be prohibited. Plants for planting, other than seeds, of planting,

than seeds, of

Coffea originating in Costa Rica or Honduras which have been Coffea

introduced into the Maltese territory before the coming into force of originating

Costa Rica or

these regulations shall only be moved within the Maltese territory and Honduras.

the Union by professional operators after they have informed the

Directorate.

Specified plants originating in a third country where the

specified organism is not present may be introduced into the Maltese

territory and the Union if the following conditions are fulfilled

(a)

the national plant protection organisation of the third

country concerned has communicated in writing to the

Commission that the specified organism is not present in the

country;

(b) the specified plants are accompanied by a

phytosanitary certificate, as referred to in regulation 15 of the

Plant Quarantine (Harmful Organisms) Regulations, stating

under the rubric ‘Additional Declaration’ that the specified

organism is not present in the country;

(c)

the professional operators being supplied with these

specified plants shall also inform the Directorate by means of

the Third Countries Notification Form available on the

Directorate’s website forty-eight hours prior to the arrival of the

plant material in Malta;

(d) on entry into the Maltese territory the specified

plants have been checked by the Directorate in accordance with

regulation 19(2) and neither presence nor symptoms of the

specified organism have been found.

(1) Specified plants originating in a third country where

the specified organism is known to be present may be introduced into

the Union and the Maltese territory where the following conditions

are fulfilled

(a)

they are accompanied by a phytosanitary certificate,

as referred to in regulation 15 of the Plant Quarantine (Harmful

Organisms) Regulations;

(b) they comply with the provisions of sub-regulation

(2) or sub-regulations (3) and (5);

(c)

the professional operators being supplied with these

specified plants shall also inform the Directorate by means of

the Third Countries Notification Form available on the

Directorate’s website forty-eight hours prior to the arrival of the

plant material in Malta.

(d) on entry into the Union and the Maltese territory

they have been checked by the Directorate in accordance to

regulation 19 and neither presence nor symptoms of the

specified organism have been found.

(2) Where specified plants originate in an area free from the

specified organism, as established by the national plant protection

organisation concerned in accordance with relevant International

Standards for Phytosanitary Measures, the following conditions shall

be fulfilled

(a)

the national plant protection organisation of the third

country concerned has communicated in writing to the

Commission the name of that area;

(b) the name of that area is stated in the phytosanitary

certificate under the rubric ‘place of origin’.

(3) Where specified plants, other than plants which have been

grown for the entire production cycle in vitro originate in an area

where the specified organism is known to be present, the

phytosanitary certificate shall state under the rubric ‘Additional

Declaration’ that

(a)

the specified plants have been produced in one or

more sites fulfilling the conditions set out in sub-regulation (5);

(b) the national plant protection organisation of the third

country concerned has communicated in writing to the

Commission the list of those sites, including their location

within the country;

(c)

phytosanitary treatments against the vectors of the

specified organism are applied in the site and its zone as

referred to in sub-regulation (5)(c);

(d) representative samples of each species of specified

plants from each site have been subject to annual testing, at the

most appropriate time, and the absence of the specified

organism has been confirmed on the basis of tests carried out in

accordance with internationally validated testing methods;

(e)

the specified plants have been transported in closed

containers or packaging, ensuring that infection with the

specified organism or any of its known vectors cannot occur;

(f)

as practically close to the time of export as possible,

the lots of the specified plants were subjected to official visual

inspection, sampling and molecular testing, carried out in

accordance with internationally validated testing methods,

confirming the absence of the specified organism, using a

sampling scheme able to identify with 99% reliability a level of

presence of infected plants of 1% or above and targeted

especially at plants displaying suspect symptoms of the

specified organism;

(g) immediately prior to export, the lots of the specified

plants were subjected to phytosanitary treatments against any of

the known vectors of the specified organism.

In addition, the phytosanitary certificate referred to

in sub-regulation (1)(a) shall indicate under the rubric ‘Place of

origin’ the identification of the site referred to in paragraph (a).

(4)

Where specified plants, which have been grown for the

entire production cycle in vitro, originate in an area where the

specified organism is known to be present, the phytosanitary

certificate shall state under the rubric ‘Additional Declaration’ that

(a)

the specified plants have been produced in one or

more sites fulfilling the conditions set out in sub-regulation (6);

(b) the national plant protection organisation of the third

country concerned has communicated in writing to the

Commission the list of those sites, including their location

within the country;

(c)

the specified plants have been transported under

sterile conditions in a transparent container that precludes the

possibility of infection by the specified organism through its

vectors;

(d) the specified plants meet one of the following

conditions

(i)

they have been grown from seeds;

(ii)

they have been propagated, under sterile

conditions, from mother plants which have spent their

entire lives in an area free from the specified organism and

which have been tested and found free from the specified

organism;

(iii) they have been propagated, under sterile

conditions, from mother plants which have been grown in

a site fulfilling the conditions of sub-regulation (5) and

which have been tested and found free from the specified

organism.

In addition, the phytosanitary certificate referred to in sub-

regulation (1)(a) shall indicate under the rubric ‘Place of origin’

the site referred to in paragraph (a) of sub-regulation (4).

(5) The site referred to in sub-regulation (3)(a) shall fulfil the

following conditions

(a)

it is authorised by the national plant protection

organisation as free from the specified organism and its vectors,

in accordance with the relevant International Standards for

Phytosanitary Measures;

(b) it is physically protected against the introduction of

the specified organism by its vectors;

(c)

it is surrounded by a zone with a width of 200m

which has been found by official visual inspection, and, in case

of suspicion of the presence of the specified organism, by

sampling and testing, to be free from the specified organism,

and is subject to appropriate phytosanitary treatments against

the vectors of the specified organism; those treatments may

include, as appropriate, removal of plants;

(d) it is subject to phytosanitary treatments that aim to

maintain freedom from vectors of the specified organism; those

treatments may include, as appropriate, removal of plants;

(e)

it is subjected annually, together with the zone

referred to in paragraph (c), to at least two official inspections

carried out at appropriate times;

(f)

throughout the production time of the specified

plants, neither symptoms of the specified organism nor its

vectors were found in the site, or, if suspect symptoms were

observed, testing has been undertaken and absence of the

specified organism has been confirmed;

(g) throughout the production time of the specified

plants, no symptoms of the specified organism were found in

the zone referred to in sub-regulation (4)(c) or, if suspect

symptoms were observed, testing has been undertaken and

absence of the specified organism has been confirmed.

(6) The site referred to in sub-regulation (4)(a) shall fulfil the

following conditions

(a)

it is authorised by the national plant protection

organisation as free from the specified organism and its vectors,

in accordance with the relevant International Standards for

Phytosanitary Measures;

(b) it is physically protected against the introduction of

the specified organism by its vectors;

(c)

it is subjected annually to at least two official

inspections carried out at appropriate times;

(d) throughout the production time of the specified

plants, neither symptoms of the specified organism nor its

vectors were found in the site, or, if suspect symptoms were

observed, testing has been undertaken and absence of the

specified organism has been confirmed.

(1) All consignments of specified plants introduced into

the Union and the Maltese territory from a third country shall be

officially checked at the point of entry into the Union and the Maltese

territory or at the place of destination established in accordance with

the Identity and Plant Health Checks of Plants, Plant Products or

other Objects carried out at a place other than Point of Entry into the

European Community Regulations and, as applicable, pursuant to

sub-regulations (2) or (3), and sub-regulation (4).

(2) In the case of specified plants originating in a third country

where the specified organism is not present or in an area referred to in

regulation 17(2), the Directorate shall carry out the following checks

(a)

a visual inspection; and

(b) in the case of suspicion of the presence of the

specified organism, sampling and testing of the lot of the

specified plants to confirm the absence of the specified

organism or its symptoms.

(3) In the case of specified plants originating in an area where

the specified organism is known to be present, the Directorate shall

carry out the following checks

(a)

a visual inspection; and

(b) sampling and testing of the lot of the specified plants

to confirm the absence of the pest or its symptoms.

(4) The samples referred to in sub-regulations (2)(b) and

(3)(b) shall be of a size that allows identifying with 99% reliability a

level of infected plants of 1% or above, taking account of ISPM No

The first sub-paragraph shall not apply to specified plants

which have been grown for the entire production cycle in vitro and are

transported in transparent containers under sterile conditions.

20. (1) Any entity, governing body, local council or any Responsibilities

other legally constituted body, which manages and, or administers or of

entities.

is responsible for any areas and, or territories on which any

susceptible plants are found, shall be obliged to follow the guidelines

issued by the Directorate and which the Director may, from time to

time, deem necessary to issue.

(2) Failure by such entity, governing body, local council or any

other legally constituted body to abide by the Directorate’s

instructions shall entitle the Director to gain access to any premises

and, or property and to take any action which is deemed necessary in

terms of these regulations. All expenses incurred by the Directorate in

exercising such action shall be borne solely by the entity, governing

body, local council or any other legally constituted body on whose

property or premises the plants are found.

21. (1) The Director shall revoke the measures taken to Powers of the

control the specified organism or to prevent it from spreading only if Director.

the Director is satisfied that it is no longer present and no further risks

exist.

(2) These regulations are without prejudice to the Trees and S.L. 594.64

Woodlands Protection Regulations and to the Flora, Fauna and S.L. 549.44

Natural Habitats Protection Regulations.

(3) Nothing in these regulations shall be construed as

contravening the provisions of the Act and regulations made

thereunder, and, or relative European Union Regulations, Directives

and Decisions in particular, but not exclusive of, Commission

Implementing Decision (EU) 2015/789 of the 18 May 2015 regarding

measures to prevent the introduction into and the spread within the

Union of Xylella fastidiosa (Wells et al.) and its amendments.

(4) Without prejudice to the provisions of these regulations,

the Director is empowered to issue additional and stricter legally

binding guidelines, as may be required, and which are conducive to

preventing the spread of the specified organism and its further entry

into Malta.

22. The Directorate shall make information available to the Awareness

general public, travellers, professional and international transport campaigns.

operators concerning the threat of the specified organism for the

Union territory. The information shall be made publicly available, in

the form of targeted awareness campaigns on the respective websites

of the Directorate or other websites designated by those bodies.

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