Control of Xylella fastidiosa (Wells et al.) Regulations, 2019

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 20,190, 17 ta’ Mejju, 2019 B 625

L.N. 98 of 2019

PLANT QUARANTINE ACT

(CAP. 433)

Control of Xylella fastidiosa (Wells et al.) Regulations, 2019

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, 2019.

(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 or Department

responsible for plant health;

"the Director" means the Director responsible for the

Directorate;

"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;

"non-professional final user" means any person that does not

qualify as a professional operator;

"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 Surveys of the

the presence of the specified organism on the specified plants. Those specified

organism.

surveys shall be carried out by the Directorate, or 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 by visual inspection,

sampling and testing. 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. They shall also take into account the technical

guidelines for the survey of Xylella fastidiosa provided on the

Commission website.

(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.

(3) The presence of the specified organism in areas other than

demarcated areas, shall be screened by one molecular test, and in case

of positive results, its presence shall be identified by carrying out, in

line with international standards, at least one more positive molecular

test. Those tests shall be listed in the Commission database of tests

for the identification of the specified organism and its subspecies and

target different parts of the genome.

The presence of the specified organism in demarcated areas

shall be screened by one test, and in case of positive results, its

presence shall be identified by carrying out, in line with international

standards, at least one positive molecular test. Those tests shall be

listed in the Commission database of tests for the identification of the

specified organism and its subspecies.

(4) The Commission shall manage and update the database

referred to in sub-regulation (3) and provide public access to it.

The tests listed in that database shall be divided into two

categories, depending on their appropriateness for the identification

of the specified organism and its subspecies in demarcated areas and

in areas other than demarcated areas.

(1)

The Directorate shall establish a plan setting out Contingency

the actions to be taken in its territory in accordance with regulations 6 plans.

to 8, regulations 10 to 15 and regulation 22 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, on request, communicate its

contingency plans to the Commission and shall inform all relevant

professional operators through publication on the internet.

(1)

Where the presence of the specified organism is

identified, the Directorate shall without delay demarcate an area in

accordance with sub-regulation (2) hereinafter referred to as a

"demarcated area".

By way of derogation from the first sub-paragraph, where the

presence of one particular subspecies of the specified organism is

confirmed, the Directorate may demarcate an area with regard to that

subspecies only.

Where the presence of more than one subspecies of the specified

organism is identified, the Directorate shall demarcate that area with

regard to the specified organism and all of its possible subspecies.

Where the identification of the presence of a subspecies is

pending, the Directorate shall demarcate that area with regard to the

specified organism and all of its possible subspecies.

The identification of the presence of the subspecies shall be

based on the results of tests referred to in regulation 4(3).

(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 5km

surrounding the infected zone. The buffer zone may be reduced

to a width of no less than 1km if there is a high degree of

confidence that the initial presence of the specified organism

did not result in any spread, and if all of the following

conditions have been fulfilled

(i) all host plants, irrespective of their health

status, have been immediately removed within a radius of

100m around the plant found infected;

(ii) no other plants have been found infected by

the specified organism in the infected zone since the

eradication measures have been taken, on the basis of

official tests carried out at least once during the course of

the year, taking into account the technical guidelines for

the survey of Xylella fastidiosa provided on the

Commission website. Those tests shall be based on a

sampling scheme able to identify with 99% reliability a

level of presence of infected plants of 1% or above, and

targeting symptomatic plants, as well as asymptomatic

plants in the proximity of the symptomatic ones;

(iii) a delimiting survey has been carried out in a

zone with a width of at least 5km surrounding the infected

zone, concluding that the specified organism has not been

found present in that zone. That survey shall be based on a

grid split into 100m × 100m squares within a zone of a

width of at least 1 km surrounding the infected zone, and a

grid split into 1km × 1km squares within the rest of the

buffer zone. In each of those squares, visual inspections

shall be carried out of the specified plants and

symptomatic plants shall be sampled and tested, as well as

asymptomatic plants in the proximity of the symptomatic

ones;

(iv) no vectors carrying the specified organism

have been detected in the infected zone since the

eradication measures have been taken, on the basis of tests

carried out twice during the flight season of the vector, and

in accordance with international standards. Those tests

shall lead to the conclusion that natural spread of the

specified organism is excluded.

When reducing the width of the buffer zone, the

Directorate shall immediately notify the Commission and the

other Member States of the justification for that reduction.

In the case of an infected zone for the purpose of

containment measures as referred to in regulation 9(1), the

buffer zone shall be of a width of at least 10km.

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) The Directorate shall keep and update a list of the

demarcated areas established in Malta and shall publish that list and

any updates. The Directorate shall notify the Commission of this list

and any updates in accordance with Commission Implementing

Decision 2014/917/EU.

(5) Where, based on the surveys referred to in regulation 4 and

on the monitoring referred to in regulation 8(8), the specified

organism is not detected in a demarcated area for a period of five (5)

years, this demarcation may be lifted. In such cases, the Directorate

shall notify the Commission and other Member States.

By way of derogation from the first sub-paragraph, where the

Directorate has reduced the buffer zone to a width of no less than 1km

pursuant to sub-regulation (2), the Directorate may lift that

demarcated area after 12 months since its initial establishment, if both

of the following conditions are fulfilled

(a)

as result of the measures taken pursuant to sub-

regulation (2), it is concluded with a high degree of confidence

that the initial presence of the specified organism was an

isolated case and no further spread occurred in the respective

demarcated area;

(b)

as practically close to the time of lifting, official

tests have been carried out within the demarcated area, taking

into account the technical guidelines for the survey of Xylella

fastidiosa provided on the Commission website, using a

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

presence of infected plants of 1% in accordance with

international standards, and targeting symptomatic plants, as

well as asymptomatic plants in the proximity of the

symptomatic ones.

Where a demarcated area is lifted pursuant to the second

sub-paragraph, the specified plants located in the previously

established demarcated area shall be subject to intensive

surveys during the following two years. That survey shall be

carried out using a sampling scheme able to identify with 99%

reliability a level of presence of infected plants of 1% or above

in accordance with international standards and based on

scientific and technical principles related to the potential

spreading of the specified organism in the immediate

surroundings, and targeting symptomatic plants, as well as

asymptomatic plants in the proximity of the symptomatic ones.

When lifting the demarcated area after 12 months since its

initial establishment, the Directorate shall immediately notify

the Commission and the other Member States of the justification

for that lifting.

(6) By way of derogation from 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, or that the specified organism has been found in a site

with physical protection from the vectors of that organism;

(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 prohibited, except in sites which are physically protected against

the introduction of the specified organism by its vectors.

(2) By way of derogation from sub-regulation (1), the

Directorate may grant authorisations for the planting of the host

plants within infected zones where containment measures pursuant to

regulation 9 are applied, except in the 20km area referred to in

regulation 9(7)(c). When granting those authorisations, the

Directorate shall give preference to host plants belonging to varieties

assessed as being resistant or tolerant to the specified organism.

(1)

The Directorate, having established the demarcated

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

out in the following sub-regulations (2) to(12).

(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) By way of derogation from sub-regulation (2)(a), the

Directorate may decide that individual host plants officially

designated as plants with historic value do not need to be removed,

provided that all of the following conditions have been fulfilled

(a)

the host plants concerned have been sampled and

tested in accordance with regulation 4(3) and have been

confirmed not to be infected by the specified organism;

(b)

the individual host plants or the area concerned

have been appropriately physically isolated from the vectors in

such a way that those plants do not contribute to the further

spread of the specified organism;

(c)

appropriate agricultural practices for the

management of the specified organism and its vectors have been

applied.

Before a derogation is granted, the Directorate shall notify

the Commission with the outcome of the sampling and testing

referred to in sub-regulation (3)(a), the description of the

measures referred to in sub-regulations (3)(b) and (3)(c) which

are intended to be taken, the justification for them, and the

location of the individual plants. The Commission shall publish

the list and the location of the host plants for which such

derogation is granted.

Each of those plants shall be officially inspected, during

the flight season of the vector, for symptoms of the specified

organism and for checking the appropriateness of the physical

isolation. When symptoms are present, the plant shall be subject

to sampling and testing for the presence of the specified

organism.

(4) 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.

(5) 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. Those treatments may include, as appropriate,

removal of plants.

(6) 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.

(7) 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.

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

organism by annual surveys, taking into account the technical

guidelines for the survey of Xylella fastidiosa provided on the

Commission website. The Directorate 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 accordance with the respective provisions of

regulation 4(1), (2) and (3).

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

into 100m × 100m squares within a zone of a width of at least 1km

surrounding the infected zone, and a grid split into 1km × 1km

squares within the rest of the buffer zone. In each of those squares,

the Directorate 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.

(9) 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.

(10) 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.

(11) 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.

(12) The Directorate shall apply appropriate agricultural

practices for the management of the specified organism and its

vectors.

(1)

By way of derogation from regulation 8, only in an Containment

infected zone included in the list published in the Government measures.

Gazette and on the Directorate’s website, and which is updated

accordingly from time to time, the Director may decide to apply the

containment measures, as set out in sub-regulations (2) to (7),

hereinafter referred to as "containment area".

(2) The Director shall authorise the removal of all plants

which have been found to be infected by the specified organism on

the basis of the official surveys referred to in sub-regulation (7).

That removal shall take place immediately after the official

identification of the presence of the specified organism. 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 official surveys taking into account the technical

guidelines for the survey of Xylella fastidiosa provided on the

Commission website), at least in 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)

within an infected zone included in the list

published in the Gazette and on the Directorate’s website, and

which is updated accordingly from time to time, and situated

within an area measuring at least 20km from the border of that

infected zone with the rest of the Union territory.

Those surveys shall be based on a grid split into 100m ×

100m squares. In each of those squares, the Member State

concerned 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 accordance with the respective provisions of regulation 4(1),

(2) and (3).

The Directorate shall immediately notify the Commission

and the other Member States of any official identification of the

presence of the specified organism in the locations referred to in

paragraph (c).

Paragraph (c) above shall not apply in the case of islands

which are entirely containment areas and are situated more than

10km to the nearest Union land territory.

(1)

This regulation shall only apply to the movement

of specified plants other than

(a)

plants which have been grown for the entire

production cycle in vitro; or

(b)

plants belonging to varieties of specified plants

which are non-susceptible to the respective strain of the sub-

species of the specified organism as included in the list

published in the Government Gazette and on the Directorate’s

website and which is updated accordingly from time to time.

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) By way of derogation to 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 100m

which has been subject to official inspections twice per year and

where all the plants found to be infected with the specified

organism or to have symptoms, have been immediately removed

and appropriate phytosanitary treatments against the vectors of

the specified organism have been applied before that removal;

(e)

it is subject to phytosanitary treatments at

appropriate times of the year 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,

taking into account the technical guidelines for the survey of

Xylella fastidiosa provided on the Commission website;

(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) By way of derogation from 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) Specified plants which have been grown for at least part of

their life in a demarcated area 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 the

following conditions have been fulfilled

(a)

they have been grown in a site that is subject to

annual official inspection, and, in the case of symptoms of the

specified organism, sampling, taking into account the technical

guidelines for the survey of Xylella fastidiosa provided on the

Commission website, as well as testing in line with international

standards for the presence of the specified organism;

(b)

they are accompanied by a plant passport prepared

and issued in accordance with regulation 8 of the Plant S.L. 433.03

Quarantine (Harmful Organisms) Regulations

However, plants for planting, other than seeds, of Coffea,

Lavandula dentata L., Nerium oleander L., Olea europaea L.,

Polygala myrtifolia L. and Prunus dulcis (Mill.) D.A. Webb, shall

only be moved within the Union if they have been grown in a site

that is subject to annual official inspection and sampling, taking

into account the technical guidelines for the survey of Xylella

fastidiosa provided on the Commission website, as well as testing

in line with international standards for the presence of the

specified organism, confirming the absence of the specified

organism, using a sampling scheme able to identify with 99%

reliability the level of presence of infected plants of 5%. In

addition, and prior to its first movement out of its production site,

each lot of plants for planting of Polygala myrtifolia L. which is

to be moved within the Union shall be subjected to official visual

inspection and sampling, as close to the time of that movement as

possible, taking into account the technical guidelines for the

survey of Xylella fastidiosa provided on the Commission website,

as well as testing in line with international standards for the

presence of the specified organism, 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 5%. By

way of derogation from the first sub-paragraph of article 4(3), the

presence of the specified organism shall be screened by one test,

and in case of positive results, its presence shall be identified by

carrying out, in line with international standards, at least one

positive molecular test. Those tests shall be listed in the

Commission database of tests for the identification of the

specified organism and its subspecies.

Without prejudice to Part A of Schedule V to the Plant S.L.433.03

Quarantine (Harmful Organisms) Regulations, no plant passport

shall be required for the movement of the host plants referred to

in this paragraph to any person acting for purposes which are

outside his trade, business or profession, and who acquires those

plants for his own use.

(10) Without prejudice to sub-regulation (9), pre-basic mother

plants as defined in regulation 3 of the Fruit Trees Propagating

Material Regulations or pre-basic material as defined in regulation 3

of the Fruit Trees Propagating Material Regulations which belong to

the species Juglans regia L., Olea europaea L., Prunus amygdalus

Batsch, P. amygdalus × P. persica, P. armeniaca L., P. avium (L.) L.,

P. cerasus L., P. domestica L., P. domestica × P. salicina, P. dulcis

(Mill.) D.A. Webb, P. persica (L.) Batsch, and P. salicina Lindley and

which have been grown outside the demarcated areas and spent at

least part of their life outside insect proof facilities, shall only be

moved within the Union if they are accompanied by a plant passport

prepared and issued in accordance with regulation 8 of the Plant

Quarantine (Harmful Organisms) Regulations and if the following

conditions have been fulfilled

(a)

they are subject to the authorisation provided for in

Commission Implementing Decision (EU) 2017/167;

(b)

within the shortest possible time prior to their

movement, they have been subjected to visual inspection,

sampling and molecular testing for the presence of the specified

organism carried out in accordance with international standards.

Without prejudice to Part A of Schedule V to the Plant

Quarantine (Harmful Organisms) Regulations, no plant passport shall

be required for the movement of the pre-basic mother plants and pre-

basic material referred to in this paragraph to any person acting for

purposes which are outside his trade, business or profession, and who

acquires those plants for its 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 regulation 8 of the Plant Quarantine S.L. 433.03

(Harmful Organisms) 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) Sub-regulations (1) and (2) shall also apply to the supply

of plants for planting of Coffea, Lavandula dentata L., Nerium

oleander L., Olea europaea L., Polygala myrtifolia L. and Prunus

dulcis (Mill.) D.A. Webb which have never been grown within a

demarcated area.

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

sub-regulations (1), (2) and (3) for 3 years from the date on which the

respective lot was supplied to or by them.

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

(1) and (2) shall declare the introduction of plant material forty-eight

(48) hours prior to its arrival in Malta, through the Supplementary

Declaration System of Malta (Intrastat) and information on each lot

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.

(6) The Directorate receiving information pursuant to sub-

regulation (5) shall immediately inform the responsible official body

of the place of destination of the lot concerned.

(7) 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 declare the introduction of plant material through the

Supplementary Declaration System of Malta (Intrastat), forty-eight

hours (48) prior to their arrival in Malta.

(8) The professional operator being supplied with specified

plants referred to in sub-regulation (7) shall keep a record of each lot

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

shall include the supplementary declaration form, all invoices and

accompanying documents (delivery notes or receipts), plant passports

in accordance with regulation 8 of the Plant Quarantine (Harmful

Organisms) Regulations where applicable.

(9) The non-professional final user being supplied with

specified plants shall also inform the Directorate by means of the EU-

Plant Notification Form (For General Public) available on the

Directorate’s website forty-eight hours (48) prior to the arrival of the

plant material in Malta irrespective of origin, location and growing

areas.

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

information referred to in sub-regulation (5) to the Commission.

(1)

The Directorate shall carry out regular official Official checks

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

of specified

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

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/s in situ regulation 10.

or 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/s, during and after removal.

The introduction into the Maltese territory of plants for

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

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

Coffea originating in Costa Rica or Honduras which have been

introduced into the Maltese territory before the coming into force of

these regulations shall only be moved within the Maltese territory and

the Union by professional operators and non-professional final users,

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)

Plants for planting, other than seeds, of Coffea,

Lavandula dentata L., Nerium oleander L., Olea europaea L.,

Polygala myrtifolia L., and Prunus dulcis (Mill.) D.A. Webb

shall only be introduced into the Union if they have been grown

in a site that is subject to annual official inspection, with sampling

and testing carried out at the appropriate times on those plants for

the presence of the specified organism and in accordance with

international standards, confirming the absence of the specified

organism, using a sampling scheme able to identify with 99%

reliability the level of presence of infected plants of 5%. In

addition, and prior to its first movement out of its production site

and as close to the time of that movement as possible, each lot of

plants for planting of Polygala myrtifolia L. shall be subjected to

official visual inspection and sampling, as well as testing in line

with international standards for the presence of the specified

organism, 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 5%;

(d)

the professional operators and the non-professional

final user 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 (48) prior to the arrival of the plant material in

Malta;

(e)

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 Introduction

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

territory and the

introduced into the Union and the Maltese territory where the Union

specified plants

following conditions are fulfilled

originating in a

third country

where the

specified

organism is

known to be

present.

(a)

they are accompanied by a phytosanitary

certificate, as referred to in regulation 15 of the Plant S.L. 433.03

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 (48) prior to the arrival

of the plant material in Malta;

(d)

the non-professional final user 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 (48) prior to the arrival

of the plant material in Malta;

(e)

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 100m

which has been subject to official inspections twice per year and

where all of the plants found to be infected with the specified

organism or to have symptoms have been immediately removed,

and appropriate phytosanitary treatments against the vectors of

the specified organism have been applied before that removal;

(d)

at appropriate times throughout the year, it is

subject to phytosanitary treatments 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

during the flight season of the vector;

(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 paragraph (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 Official checks

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

into the Union

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

territory.

territory or at the place of destination established in accordance with

the Plant Quarantine (Harmful Organisms) Regulations and, as S.L. 433.03

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(b), 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

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

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

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

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

exist.

(2) These regulations shall apply without prejudice to the

Trees and Woodlands Protection Regulations and to the Flora, Fauna

and Natural Habitats Protection Regulations.

(3) Nothing in these regulations shall be construed as

contravening the provisions of the Act and regulations made there

under, 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. (1)

The Directorate shall make information available to

the general public, travellers, professional and international transport

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. This shall include posters

or brochures and on the respective website of the Directorate.

(2) (a)

Seaports, airports and international transport

operators shall make information available to travellers concerning

prohibitions, requirements and exemptions referred to in regulations

10 to 12 and 16 to 18 as regards the introduction of specified plants

into the Maltese territory.

They shall provide that information in the form of posters or

brochures and, where applicable, on their internet sites.

(b) Postal services and professional operators involved in sales

through distance contracts shall also make available to their clients

that information concerning such specified plants at least through the

internet.

23. The Control of Xylella fastidiosa (Wells et al.) Regulations Repeal.

are hereby repealed.

B

€1.26