CONTROL OF LEGIONELLA REGULATIONS

SUBSIDIARY LEGISLATION 465.03

CONTROL OF LEGIONELLA REGULATIONS

10th January, 2006

LEGAL NOTICE 5 of 2006, as amended by Legal Notice 262 of 2006.

The title of these regulations is the Control of Legionella

Regulations.

RECOMMENDED INSPECTION FREQUENCIES FOR RISK SYSTEMS

CHECKLIST 1: COOLING WATER INSTALLATIONS

SYSTEM/SERVICES

TASK

FREQUENCY

C o o l i n g t o w e r s a n d Monitor water quality, water use and 6 monthly

evaporative

biocide/chemical use to assess and ensure

condensers

effectiveness of water treatment regime,

including

key

chemical

and

microbiological parameters and

observations of internal condition of

pond, pack and water

Central control function, conductivity M o n t h l y t o 3

sensor calibration, blow down function, m o n t h l y,

u n i f o r m i t y o f w a t e r d i s t r i b u t i o n , according to risk

condition of sprays/troughs, eliminators,

pack, pond, immersion heater, fan and

sound attenuators

C l e a n a n d d i s i n f e c t c o o l i n g t o w e r s / 6 monthly

evaporative condensers, make up tanks

and associated systems, including all

wetted surfaces, descaling as necessary.

Packs should be removed and cleaned

where practicable.

CHECKLIST 2: HOT AND COLD WATER SERVICES

SERVICES

TASK

FREQUENCY

Warm water services

Arrange for samples to be taken from hot 6 monthly

water heaters, in order to note condition

of drain water

Check temperatures in flow and return at Daily

calorifiers

Check temperature up to 1 minute to see Weekly

if it has reached 50ºC in the sentinel taps

Visual check on internal surfaces of Annually

water heaters for scale and sludge

C h e c k r e p r e s e n t a t i v e t a p s f o r Monthly

temperature as above on a rotational

basis

Cold water services

Check tank water temperature remote 6 monthly

from ball valve and mains temperature at

ball valve. Note maximum temperatures

recorded by fixed max/min thermometers

where fitted

CONTROL OF LEGIONELLA

SERVICES

TASK

FREQUENCY

Note: This temperature Check that temperature is below 20ºC Weekly

may not be reached after running the water for up to 2

d u r i n g t h e s u m m e r minutes in sentinel taps

months in Malta

Visually inspect cold water storage tanks 6 monthly

and carry out remedial work where

necessary

C h e c k r e p r e s e n t a t i v e t a p s f o r Monthly

temperature as above on a rotational

basis

Shower heads

Dismantle, clean and descale shower Quarterly, or as

heads and hoses

n e c e s s a r y,

whichever

comes first

Little used outlets

Flush through and purge to drain

Weekly

CHECKLIST 3: OTHER RISK SYSTEMS

SYSTEM/SERVICES

TASK

FREQUENCY

Spray humidifiers, air Clean and disinfect spray humidifiers/air 6 monthly

w a s h e r s a n d w e t washers and make up tanks including all

scrubbers

wetted surfaces, descaling as necessary

Confirm the operation of non chemical Weekly

water treatment (if present)

Water softeners

Clean and disinfect resin and brine tank - A s

check with manufacturer what chemicals recommended by

can be used to disinfect resin bed

manufacturer

E m e r g e n c y s h o w e r s Flush through and purge to drain

6 monthly or

and eye wash sprays

more frequently

if recommended

by manufacturer

Sprinkler and hose reel When witnessing tests of sprinkler blow Quarterly

systems

down and hose reels ensure that there is

minimal risk of exposure to aerosols

Lathe and machine tool C l e a n a n d d i s i n f e c t s t o r a g e a n d 6 monthly

coolant systems

distribution system

Spa baths

Check filters - sand filters should be Daily

backwashed daily

Check water treatment - pools should be 3 times daily

continuously treated with oxidising

biocide

Clean and disinfect entire system

Weekly

Horticultural misting Clean and disinfect distribution pipe Annually

systems

work, spray heads and make-up tanks,

including all wetted surfaces, descaling

as necessary

CONTROL OF LEGIONELLA

SYSTEM/SERVICES

TASK

FREQUENCY

F o u n t a i n s a n d w a t e r Clean and disinfect ponds, spray heads Weekly

features (particularly and make-up tanks, including all wetted

indoors)

surfaces, descaling as necessary

In these regulations, unless the context otherwise requires

"accreditation" means third-party attestation by the Maltese

National Accreditation Body or by any other accreditation body as

recognised by the Maltese National Accreditation Body, in

accordance with the Establishment of the Accreditation Directorate

Order, of a laboratory, conveying formal demonstration of its

competence to carry out specific test;

"accredited laboratory" means a laboratory to which

accreditation has been granted according to the requirements of

MSA ISO/IEC EN 17025;

"the Act" means the Public Health Act;

"authorised officer" means any duly qualified person authorised

by the Superintendent to carry out any functions under these

regulations and includes any nominated officer;

"biocide" means a physical or chemical agent capable of killing

micro-organisms, including Legionella;

"clean" means to render free from visible sludge, foam, slime

(including algae and fungi), rust, scale, dirt, and any deposit or

accumulation of impurities or other foreign material;

"cold water system" means an installation of plant, pipes and

fittings in which cold water is stored, distributed and subsequently

discharged;

"cooling tower systems" includes

(a) a cooling tower, or a number of interconnected cooling

towers that use the same recirculating water; and

(b) any machinery that is used to operate any such tower;

and

(c) any associated tanks, pipes, valves, pumps or controls;

"cooling tower" means a device whose main purpose is to cool

water by direct contact between that water and a stream of air;

"designated area" means any premises or part thereof to which

the public or a section of the public has access, whether on payment

or otherwise;

"disinfect" means to carry out a process which is intended to kill

or remove pathogenic micro-organisms;

"drift" means the water aerosol which emerges from the airflow

outlet of a cooling system;

"evaporative condenser" means a device whose main purpose is

to cool a fluid by passing that fluid through a heat exchanger which

is itself cooled by the contact of water passing through a stream of

air;

"guidelines" means the European Guidelines for Control and

Prevention of Travel Associated Legionnaires’ Disease produced

b y t h e E u r o p e a n Wo r k i n g G r o u p f o r L e g i o n e l l a I n f e c t i o n s

(EWGLI) and endorsed by the Committee for the Epidemiological

Surveillance and Control of Communicable Diseases in the

Community, instituted by Decision 2119/98/EC of the European

Parliament and the Council;

"heat exchanger" means a device for transferring heat between

fluids which are not in direct contact with one another;

"heterotrophic colony count" means an estimate of the number of

viable units of bacteria per millilitre of water made using the pour

plate, spread plate or membrane filter test (also known as the total

bacterial count, total plate count or viable bacterial count test)

method;

"legionella" means bacteria belonging to the genus Legionella;

"premises" includes all non-domestic premises used for or in

connection with the carrying on of a trade or business (whether for

profit or not) and should include any healthcare facility and

schools;

"responsible person" includes the person who owns, manages or

controls the cooling tower systems, or evaporative condensers, or

hot and cold water systems, or water fountains or a number of these

systems in the same premises;

"sentinel taps", in relation to a hot water system, means the first

and last taps on a recirculating system. For cold water systems (or

non-recirculating hot water systems), the nearest and furthest taps

from the storage tank. The choice of sentinel taps may also include

taps which are considered to represent a particular risk;

"spa pool" includes a bath or a small pool where warm water is

constantly recirculated, through high velocity jets or with the

injection of air to agitate the water;

"the Superintendent" means the Superintendent of Public Health;

"warm water system" means a piped water supply, including any

thermostatic mixing valve, which is designed to supply water at a

temperature of between 30ºC and 60ºC;

"water" means water supplied through the main water

distribution system or water supplied by an authorised private

water supplier or through a water supply approved by the

Superintendent or by the relevant competent authorities;

"water fountain" means any water feature located in a designated

area.

ACTION LEVELS FOLLOWING MICROBIOLOGICAL MONITORING

FORCOOLING TOWER SYSTEMS AND EVAPORATIVE CONDENSERS

HETERO-

TROPHIC

COLONY

LEGIONELLA

COUNT 1 CFU/

ACTION REQUIRED ON

NOTIFICATION TO

ML AT 30ºC BACTERIACF

SYSTEM

SUPERINTENDENT

U/LITRE 2

(Minimum 48

hours

incubation)

<10,000

<1000

System under control

None

>10,000 and

>1000 and

Review programme operation - Following resampling and similar

up to 100,000

up to 10,000

The count should be confirmed by c o u n t s a r e c o n f i r m e d , t h e

immediate re-sampling. If similar Superintendent is to be informed in

count is found again, a review of writing within 24 hours of receiving

t h e c on t ro l m e a s u r e s a n d r i s k the laboratory report and should

assessment should be carried out include copies of laboratory results

to identify any remedial actions. together with the control measures

being taken by the responsible

person to remedy the situation.

>100,000

>10,000

Implement corrective action -

Once microbiological results

The system should immediately indicate these levels of bacterial

be re-sampled. It should then be c o u n t s , t h e r e s p o n s i b l e p e r s o n

‘shot dosed’ with an appropriate within 24 hours of receiving the

biocide, as a precaution. The risk laboratory report shall inform the

assessment and control measures Superintendent by phone and in

should be reviewed to identify w r i t i n g w i t h i n 4 8 h o u r s w h i c h

remedial actions.

report should include copies of the

laboratory results together with the

control measures being taken to

remedy the situation.

Colony count determined by pour plate method according to ISO 6222(20) or by spread plate

method on yeast extract agar 2 Determined in accordance with ISO 11731(19)

(1) Cooling tower systems and evaporative condensers are

prohibited to be newly installed on healthcare facilities and

schools.

(2) Installation of new cooling tower system or evaporative

condenser on any other premises should be restricted to those cases

only where no other suitable dry cooling facility is possible as an

alternative.

TEMPERATURE CONTROL FOR HOT AND COLD WATER SYSTEMS

STANDARD TO MEET

FREQUENCY

CHECK

NOTES

COLD WATER

HOT WATER

Weekly

Sentinel taps

The

water The

w a t e r This check makes sure that

temperature

temperature should t h e s u p p l y a n d r e t u r n

s h o u l d b e b e l o w b e a t l e a s t 5 0 º C temperatures on each loop

20ºC or less after within a minute of are unchanged i.e. the loop

running the water running the water is functioning as required

for up to two

minutes

Monthly

If fitted, input to

The water supply to One way of measuring this

thermostatic

the

TMV is to use a surface

mixer

valves

temperature should temperature probe

(TMV) on a

be at least 50ºC

sentinel basis

within a minute of

running water

Water leaving and

O u t g o i n g w a t e r If fitted, the thermometer

returning to the

should be at least pocket at the top of the hot

water heater

60ºC, return at least water storage heater and on

50ºC

th e retu r n le g are use fu l

points for accurate

temperature measurement.

If

installed,these

measurements could be

carried out and logged by a

building management

system

Six monthly

I n c o m i n g c o l d The water should

The most convenient place

water inlet (at preferably be

to measure is usually at the

least once in the below 20ºC at all

ball valve outlet to the cold

winter and once in times

water storage tank

summer)

Six monthly

Representative The

water The

w a t e r This check makes sure that

temperature should t h e w h o l e s y s t e m i s

number of taps on t e m p e r a t u r e

a rotational basis should be 20ºC or b e a t l e a s t 5 0 º C working properly

less after running within a minute of

the water for two running the water.

minutes

The difference

between the highest

and

lowest

temperature

recorded at the taps

after one minute

should not be

greater that 10ºC

CONTROL OF LEGIONELLA

(1) At the stage of installation of cooling tower system or

an evaporative condenser, inspection shall be carried out by

competent persons so that the cooling tower and evaporative

condenser pose minimal health risk to occupants of the premises

and members of the public.

(2) Cooling systems shall be designed and constructed so as to

minimise the release of drift and to aid safe operation, regular

cleaning and disinfection.

ACTION LEVELS FOLLOWING MICROBIOLOGICAL MONITORING

FOR HOT AND COLD WATER SYSTEMS

NOTIFICATION TO

ACTION REQUIRED ON SYSTEM

SUPERINTENDENT

System under control

None

Either

Following resampling and similar

(i) If only one or two samples c o u n t s a r e c o n f i r m e d , t h e

are positive, systems should Superintendent is to be informed in

be re sampled. If a similar writing within 24 hours of receiving

count is found, then review of the laboratory report, and should

the control measures and risk include copies of laboratory results

assessment should be carried together with the control measures

out to identify any remedial b e i n g t a k e n b y t h e r e s p o n s i b l e

person to remedy the situation

actions;

(ii) If the majority of samples are

positive, the system may be

colonised, albeit at a low

level, with Legionella.

Disinfection of the system

should be considered but an

immediate review of control

measures and risk assessment

should be carried out to

identify any other remedial

action required.

The system should be re-sampled O n c e m i c r o b i o l o g i c a l r e s u l t s

a n d a n i m me d i a t e r e v i ew o f t h e indicate these levels of bacterial

c o n t r o l m e a s u r e s a n d r i s k counts, the responsible person within

assessment carried out to identify 24 hours of receiving the laboratory

a n d r e m e d i a l ac t i o n s , i n c l u d i n g r e p o r t

shall

inform

the

possible disinfection of the system S u p e r i n t e n d e n t b y p h o n e a n d i n

writing within 48 hours which report

should include copies of the

laboratory results together with the

c o n t r o l m e a s u r e s be i n g t a k en t o

remedy the situation

Determined in accordance with ISO 11731(19)

CONTROL OF LEGIONELLA

The cooling tower or evaporative condenser shall be

located at least five metres away from air circulating and

ventilating inlets, open windows and occupied areas, pedestrian

thorough fares, traffic areas, areas of public access, exhaust

discharge from kitchens, air handling systems or other areas where

nutrients conveyed from these systems could assist in the growth of

legionella.

CONFIRMATION DECLARATION OF FEES

DUE TO THE SUPERINTENDENT OF PUBLIC HEALTH

The Superintendent of Public Health

Health Division

I, the undersigned, in my capacity of ................................................. (position) of

.............................................. (premises name) hereby declare that I will pay, within

one month’s time of receipt of invoice, all the expenses that the Health Division will

incur in the sampling, transportation, preparation and analysis of ........... (number) of

samples, which have been taken from ................................................(premises

name and address) on the .................... (date of sampling) as part of the investigation

of a case or suspected case of Legionnaire’s disease.

(Sgd)

Name and Surname

o.b.o.

I.D. No.

Date of Birth

Place of Birth

Parent’s Name and Surname

Residential Address

Billing Address

VAT No.

Date

Make-up water shall be supplied either through the main

distribution system or by an authorised water supplier or through a

water supply approved by the Superintendent.

HEALTH AUTHORITY

ENFORCEMENT NOTICE

(As per regulation 18(2) of the Control of Legionella Regulations)

Date: ...........................................

1. Following investigations carried out by the Superintendent of Public Health,

it was found that the risk of infection from Legionnaire’s Diseases is significant at

2. The risk of infection from Legionnaire’s Diseases relates to: ........................

3. Without prejudice to the Superintendent’s right to take action in accordance

with the provisions of the Control of Legionella Regulations, you are hereby

requested to IMMEDIATELY close down the ............................................................

until further notice.

Superintendent of Public Health

(1) Effluent water from cooling towers and evaporative

condensers shall be discharged into the public sewers as approved

by the respective competent authorities.

(2) The concentration of chemicals in the effluent shall be

within the limits established by the respective competent

authorities.

(1) Cooling towers and evaporative condensers shall be

commissioned, approved and certified by a competent warranted

engineer in terms of the Inġiniera Act before use to ensure that they

operate correctly and safely.

(2) The entire air-conditioning system shall be clear of any

construction debris and dirt, and cleaned before operation starts.

(3) Precautions shall be taken to control the risks during

commissioning, start up and during the normal operation of the

system as per guidelines.

It shall be the duty of the responsible person to ensure that

(a) any cooling tower system or evaporative condenser in

use is maintained and tested in accordance with the

guidelines;

(b) the water of the cooling tower system or evaporative

condenser is maintained in a clean condition;

(c) the water of the cooling tower system or evaporative

condenser is continuously treated with

(i)

one or more biocides to effectively control the

growth

of

micro-organisms,

including

Legionella; and

(ii) chemicals or other agents to minimise scale

formation, corrosion and fouling;

(d) a chlorine-compatible bio-dispersant is added to the

recirculating water of the cooling tower system or

evaporative condenser, and that the system is then

disinfected, cleaned and re-disinfected

(i)

immediately prior to initial start up following

commissioning, or any shut down period of

greater than one month; and

(ii) at intervals not exceeding six months;

(e) the cooling tower system or the evaporative condenser

are inspected in accordance with the guidelines and

Schedule 1;

(f)

at least once every month take a sample of the

recirculating water of the cooling tower system and the

evaporative condenser to an accredited laboratory for

testing for heterotrophic colony count and once every

six months for legionella;

(g) a water sample shall be taken before the dosing of

biocide and in accordance with the guidelines.

(1) The responsible person must ensure that the actions

following microbiological monitoring of cooling towers and

evaporative condensers is in accordance with the procedures laid

down in Schedule 2.

(2) The responsible person shall immediately inform the

Superintended of any situation provided for in Schedule 2.

(3) The responsible person shall carry out any further

monitoring and remedial actions as m ay be directed by the

Superintendent.

(4) The Superintendent may require the systems or part thereof

to be shutdown until all necessary remedial actions have been taken

by the responsible person and until microbiological sampling

results of any system would have returned within the recommended

acceptable levels as indicated in Schedule 2.

The responsible person shall ensure that

(a) unless the system is shut down or drained of water or

is otherwise not in use, any hot and cold water system

that the responsible person owns, manages or controls

is maintained and tested in the manner set out in these

regulations and according to the guidelines;

(b) the hot and cold water system is disinfected by heat or

chlorination and cleaned immediately prior to initial

start up following commissioning, or any shut down

period of greater than one month;

(c) the hot and cold water system is disinfected by one or

more of the following methods

(i)

at least once each month by heat or chlorination;

or

(ii) continuously by means of automatic low level

chlorination; or

(iii) continuously by means of ultra-violet light

treatment; or

(iv) a method approved in the guidelines;

(d) the hot and cold water system is inspected and that the

hot and cold water systems are maintained at all times

in accordance with the guidelines and Schedule 1 and

3;

(e) when biocides are used to treat water systems, they are

meticulously controlled and checked at least weekly or

as otherwise indicated to ensure that it is operating

correctly;

(f)

at least once every six months a sample of the water

from the hot and cold water system is taken and

delivered to an accredited laboratory for testing and

reporting on Legionella.

(1) The responsible person must ensure that the actions

following microbiological monitoring of hot and cold water

systems are in accordance with the procedures laid down in

Schedule 4.

(2) The responsible person shall immediately inform the

Superintended of the situation provided for in Schedule 4.

(3) The responsible person shall carry out any further

monitoring and rem edial actions as may be directed by the

Superintendent.

(4) The Superintendent may require the systems or part thereof

to be shut down until all necessary remedial actions have been

taken by the responsible person and until microbiological sampling

results have returned within the recommended acceptable levels in

Schedule 4.

(1) It shall be the duty of the responsible person to ensure

that

(a) any water fountain under his responsibility is

maintained and tested in accordance with the

guidelines and Schedule 1;

(b) water in a water fountain is sampled

(i)

at least once a month for the purpose of

determining the heterotrophic colony counts;

and

(ii) at least once every six months for the purpose of

detecting legionella bacteria.

(2) The responsible person shall immediately inform the

Superintendent of the situation provided for in Schedule 2.

(3) The Superintendent may require the responsible person to

carry out tests and maintenance of water fountains as he may deem

necessary.

(1) It shall be the duty of the responsible person to ensure

that any spa pool and any other type of water system under his

responsibility is maintained and tested in accordance with the

guidelines and Schedule 1.

(2) Spa pools on display in retail outlets or exhibitions shall be

treated in the same manner as if they were being used.

(1) The responsible person shall

(a) carry out a risk assessment to identify and assess the

risk of exposure to legionella bacteria from work

activities and the water systems on the premises under

his control as identified in the guidelines; and

(b) identify any necessary precautionary measures which

may need to be adopted; and

(c) review the assessment either annually or when the

situation changes or when the original assessment may

no longer be valid; and

(d) keep a fully documented record of the risk assessment.

(2) When the risk assessment reveals that there is a foreseeable

risk which cannot be eliminated, the responsible person shall adopt

a scheme specifying the measures to be taken to minimise the risk

of exposure.

(3) The risk assessment and operation of the control measures

shall be audited by an independent competent person at least every

two years.

(4) All maintenance and risk assessment records shall be

retained for at least five years.

(1) The

responsible

person

shall

inform

the

Superintendent of an outbreak of legionnaire’s disease or if it is

suspected to have occurred.

(2) In the event or on the suspicion of an outbreak of

legionnaires’ disease, the responsible person shall implement all

instructions which may be issued by the Superintendent.

(1) It shall be the duty of the Superintendent to investigate

any case or suspected case of Legionnaires’ disease at any premises

and to cause the sampling and analysis of any samples required to

investigate such case or suspected case.

(2) The expenses incurred for the elevation, transportation,

preparation and analysis of samples in case of initial investigation

of a case or suspected case of legionnaire’ disease shall be

encumbered by the Superintendent.

(3) If the results of the initial samples indicate the presence of

Legionella species, or if the investigation is within twenty-four

months of the first notified case or suspected case, the expenses of

follow-up samples or initial samples, as the case may be, shall be

encumbered by the responsible person

Provided that the responsible person of the premises shall

sign a priori the declaration attached as Schedule 5 to these

regulations confirming his acceptance to pay any fees due to the

Superintendent.

(4) Any person who fails to comply with sub-regulation (3)

shall be guilty of an offence and the court, besides awarding

punishment, shall oblige the accused to pay the due fees.

(1) In the event that the responsible person fails to follow

the instructions referred to in the preceding regulations, or the

Superintendent considers that the risk of infection with legionella

from that particular premises is significant, he may order that the

premises, part of the premises or any water related system, be

immediately closed until the risk of infection is controlled.

(2) The Superintendent shall issue an enforcement notice to the

responsible person and shall be in the form specified in Schedule 6,

or in any other modified form as the Superintendent may deem

appropriate in the particular circumstances.

(3) Once the premises, part of the premises or any water related

system has been closed by an enforcement notice issued by the

Superintendent, the same enforcement notice may be lifted only

after it is confirmed by the Superintendent that the risk of infection

has been controlled.

(4) Any person who fails to comply with the enforcement

notice issued under sub-regulation (2) shall be guilty of an offence

under the Act.

Any person who contravenes any of the provisions of these

regulations shall be guilty of an offence under the Act.

CONTROL OF LEGIONELLA