Regulations, 2011

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 18,702, 25 ta’ Jannar, 2011

Taqsima B

L.N. 19 of 2011

PLANT QUARANTINE ACT

(CAP. 433)

Plant Quarantine (Harmful Organisms) (Amendment)

Regulations, 2011

IN exercise of the powers conferred by article 32 of the

Plant Quarantine Act, the Minister for Resources and Rural Affairs,

has made the following regulations

(1) The title of these regulations is the Plant Quarantine Title and scope.

(Harmful Organisms) (Amendment) Regulations, 2011 and they

shall be read and construed as one with the Plant Quarantine

(Harmful Organisms) Regulations, 2004, hereinafter referred to as L.N. 97 of 2004.

“the principal regulations”.

(2) The scope of these regulations is to transpose

Council Directive 2009/143/EC amending Council Directive

2000/29/EC.

(3) These regulations make provisions for the

delegation of the tasks provided for in these regulations, including

the delegation of the tasks of laboratory testing.

Regulations 4A to 4K of the principal regulations shall be

renumbered as regulations 4B to 4L respectively.

Immediately after regulation 4 of the principal

regulations there shall be added the following new regulation

“Responsibility for execution of tasks.

(1)

For the purpose of this regulation,

and unless the context otherwise requires

“ l a w f u l p e r s o n ” m e a n s a n y o f fi c i a l

laboratory, university, research institute, private

laboratory, professional person and any other

person or body lawfully authorised by the Director

to act on his behalf;

“public functions” means activities and tasks

covered by the Public Administration Act.

(2)

In these regulations, any reference

made to the Director shall be construed as a

reference to the Director responsible for Plant

Health, and the Directorate shall be construed

accordingly and shall include its Director, or any

person lawfully empowered or engaged by the

Director to act on his behalf.

(3)

The Director may delegate any

task provided for in these regulations to be

accomplished under his authority and supervision

to a person lawfully appointed or empowered by

him to act on his behalf, provided that such person,

or any other member appointed by him has no

personal or conflict of interest in the outcome of

any measure to be taken.

(4) The Director shall ensure that such

person is under his officially approved authority

and is exclusively charged with specific public

functions, with the exception of laboratory testing

which such person may perform even where the

laboratory testing does not form part of his specific

public functions.

(5) Notwithstanding sub-regulation (4)

hereof, the Director may delegate any laboratory

testing provided for in these regulations to any

person lawfully authorised or engaged by him

who does not comply with the provisions of sub-

regulation (4) hereof.

(6) The person lawfully delegated by the

Director to carry out laboratory testing shall be in

conformity to the criteria established in Schedule

XXIII to these regulations

Provided that these criteria may

be amended from time to time, as published by the

Directorate.”.

4. Schedules XIV to XXII of the principal regulations shall

be amended as follows

(a) in Schedule XIV, for the words “(Regulation 4A)

there shall be substituted the words “(Regulation 4B)”;

(b) in Schedule XV, for the words “(Regulation 4B)

there shall be substituted the words “(Regulation 4C)”;

(c) in Schedule XVI, for the words “(Regulation 4C)

there shall be substituted the words “(Regulation 4D)”;

(d) in Schedule XVII, for the words “(Regulation 4D)

there shall be substituted the words “(Regulation 4E)”;

(e) in Schedule XVIII, for the words “(Regulation 4E)

there shall be substituted the words “(Regulation 4F)”;

(f) in Schedule XIX, for the words “(Regulation 4F)

there shall be substituted the words “(Regulation 4G)”;

(g) in Schedule XX, for the words “(Regulation 4G)

there shall be substituted the words “(Regulation 4H)”;

(h) in Schedule XXI, for the words “(Regulation 4H)

there shall be substituted the words “(Regulation 4I)”;

(i) in Schedule XXII, for the words “(Regulation 4J)

there shall be substituted the words “(Regulation 4K)”.

Immediately after Schedule XXII to the principal

regulations there shall be added the following new schedule

“SCHEDULE XXIII

(Regulation 4A)

CRITERIA FOR DELEGATION OF LABORATORY TASKS

Persons lawfully appointed by Director to whom laboratory

tasks are delegated or assigned shall fulfil the following criteria:-

1. They shall be independent and impartial, having no

conflict of interest between the exercise of the tasks delegated

to them and the exercise of other activities carried out by them.

Persons lawfully delegated for carrying out laboratory tasks may

be requested to sign a declaration in this regard.

2. They shall treat all information related to the delegated

tasks as private confidential and shall not be allowed to submit in

any manner whatsoever such information to third parties or publish

such information.

3. They shall be familiar with relevant legislation including

international, EU and national legislation, having at least five (5)

years’ experience in related phytosanitary matters.

4. They shall use appropriate diagnostic methods and

procedures for tasks delegated to them. Methods used should be in

accordance with relevant EU legislation where applicable. When

this is not available, EPPO or IPPC diagnostic protocols and other

methods may be considered, according to the circumstances of use.

5. Laboratories shall be able to maintain and develop the

necessary expertise and infrastructure to fulfil the tasks delegated

to them.

They shall carry out diagnostic procedures in a quality-

assured manner. In case of laboratories, these shall comply with at

least one of the following criteria

i) be accredited according to MSA EN ISO/IEC 17025

for plant health diagnosis; or

ii) be designated as a National Reference Laboratory

for specific pests or diseases in the area of plant health; or

iii) be nominated as an official control laboratory for

plant health diagnosis in its country; or

iv) be under the management of a professional or

professionals with the necessary qualifications or experience

as indicated in paragraph 7 hereof.

In case of professionals delegated to carry out laboratory

tasks, they shall be in possession of a Masters Degree or a Doctorate

in a discipline relevant to the tasks delegated to them or have at least

ten (10) years experience as an equivalent in the diagnosis of plant

pests and diseases. Such professionals shall carry out tasks assigned

to them in laboratories with the appropriate infrastructure.”.

€0.19