STANDARDS FOR THE DESIGN AND OPERATION OF VECTOR PROTECTED

standards for the design and operation of vector protected facilities for the keeping of animals for experimental infections with vector-born

STANDARDS FOR THE DESIGN AND OPERATION OF VECTOR PROTECTED FACILITIES
FOR THE KEEPING OF ANIMALS FOR EXPERIMENTAL INFECTIONS WITH
VECTOR-BORNE ANIMAL PATHOGENS
PART I
Purpose and Scope of the document
1.
Scope and purpose
This document is provided as a guide for the minimum requirements that
need to be adhered to in terms of the location, design, structure and
operation of a vector protected animal facility to be used to conduct
experimental infections with vector-borne or vector-transmissible
animal diseases. The purpose of the vector protected facility is to
prevent the spread or introduction of a transmissible disease from
experimentally infected animals through contacts with arthropod
vectors. The document further describes the documentation that is
required for the registration and operation of a vector protected
animal facility.
2.
Legislation
1.
The Animal Disease Act, No 35 of 1984, and associated
regulations as amended from time to time.
2.
Animals Protection Act 71 of 1962
3.
Veterinary and para-veterinary Professions Act, Act 19 of 1982
3.
Definitions
Vector An arthropod that transmits an infectious agent from one
infected animal to another; commonly mosquitoes, flies and lice.
Vectors can transmit infectious diseases either actively or passively
as biological vectors, such as mosquitoes and ticks that may carry
pathogens that can multiply within their bodies and be delivered to
new hosts usually by biting; or as mechanical vectors, such as flies
that can pick up infectious agents on the outside of their bodies and
transmit them through physical contact.
Vector-borne pathogen An animal pathogen that is transmitted from one
host animal to another through an intermediary vector organism.
Vector-protection Vector protection is the combination of physical
barriers and standard operating procedures that will minimise the risk
of a vector entering the facility, picking up a pathogen from a host
animal and leaving the facility into the immediate environment.
Vector protected facility The enclosed area that is used to contain
and maintain animals for the duration of an experimental infection.
Under normal operations the facility will provide a physical barrier,
able to prevent any arthropod vector from entering into any area
enclosed by the structure.
Experimental infection A procedure of artificial infection of an
animal to amplify a pathogen in vivo for preparation of research
material or biological reagents, to study disease pathogenesis or to
test intervention strategies like potential vaccines, remedies, or
therapies.
PART II
Structural design and operational requirements
1.
Facility design
1.
Building site and structure
*
It is recommended that the building be located away from other
animal housing facilities or areas that could attract or allow
insects to breed.
*
Access to the site must be controlled and it should not be open to
the general public.
*
The building must be a solid walled building with a solid roof or
ceiling and there must not be any openings or cracks at the joints
or seals of the walls, doors and roof.
*
There must be a solid floor that can be easily cleaned, with a
slope into a drain to prevent water pooling inside the facility.
*
All drains must be closed off by insect proof mesh or liquid
traps.
2.
Doors
Access to the animal stable area must be through a double door
entry-exit system of which only one door can be opened at a time.
Doors must be locked at all times and access restricted to authorised
personnel. Entrances to the stable areas must have foot baths
containing disinfectant that is changed at least once a day. An insect
trap must be placed in the room/passage between doors. Additionally
the use of “air curtains” that blow air downwards over the entry
points to prevent vectors from gaining access could be implemented.
Direct access to office and change rooms from outside should be
restricted to authorised personnel and it should not be possible to
enter directly into stable areas from such rooms. Change or ante rooms
should have insecticide dispensers for spray treatment of protective
clothes.
3.
Windows
If glass windows are installed, they must not be openable and must be
protected from breakage by being double glazed or covered with another
form of physical protection that can withstand reasonable impacts and
prevent breakage.
4.
Air, ventilation and temperature control
Ample fresh air must be provided to ensure the welfare of animals. Air
inlets and outlets to be covered in 2 layers of 1.6 mm (depending on
the target insect species) plastic or material mesh impregnated with
an insecticide registered for use against the target insect species in
terms of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock
Remedies Act 1947 (Act no 36 of 1947), together with a larger robust
mesh external to the plastic mesh to protect from birds, monkeys etc.
The mesh must be regularly inspected, cleaned and replaced as
necessary.
Acceptable temperature and fresh air supply must be maintained to
safeguard the welfare of the animals within the facility. Fresh air
shouldbe supplied at a rate to provide at least 12 air changes per
hour. The supply of fresh air together with heavy roof insulation and
roof overhangs air-conditioning or dehumidifiers may be used to manage
temperature within an acceptable range.
5.
Differential pressure
A positive differential pressure must be achieved through control of
the size of air outlets to maintain a pressure difference of 10 – 15
Pa. This pressure difference should be measured and displayed on a
certified instrument.
6.
Change rooms for workers
During the running of infection experiments, personnel access to the
stable area should be via a change room where workers can don on and
don off PPE. The PPE should include footwear that is suitable for use
with disinfectant footbaths (gumboots). Private clothes must be kept
separately preferably in a locker so that it does not come into
contact with the clean protective clothing.
2.
Outside environment
The area around the building should be de-vegetated or be constructed
of a solid, artificial surface to at least a 2m radius and kept free
from standing or leaking water, waste, animals or other insect
attractants.
Vector control must be carried out and monitored (e.g using
Onderstepoort light traps for Culicoides collection).
3.
Backup and Emergency systems and plans
1.
Real-time monitoring and notification systems must be available
for the detection and reporting of over- or under temperature,
electricity supply failure, and loss of ventilation or positive
pressure.
2.
Backup power must be available to the air handling unit so that
fresh air supply and the maintenance of a positive pressure
inside the facility remain uninterrupted.
3.
Evacuation plans. Charts, signs and evacuation instruction must
be visible on the in- and outside of the facility. The
instructions should include procedures to remove and safely keep
animals outside the facility, if possible, during emergencies.
Emergency door release or unlocking mechanisms should be
available for use in emergencies.
4.
Operations
1.
Staff training
Al staff involved in any aspect of animal care, experiments, cleaning
and routine maintenance should be thoroughly trained in all applicable
SOPs, biosecurity measures, safety and emergency procedures. Records
must be available.
2.
Specific biosecurity measures
Biosecurity is to be maintained through strict access control,
facility design, and the implementation of SOPs specific to the
registered facility. Auditable training and implementation records
together with the relevant SOP’s (Appendix II) should be kept on site.
The inside and outside of the facility must be treated with an
approved, residual action insecticide and insect repellent registered
for use against the target insect species in terms of the Fertilizers,
Farm Feeds, Agricultural Remedies and Stock Remedies Act 1947 (Act no
36 of 1947) at least before any animals are introduced and after
animals are removed.
Washing and changing facilities and PPE treated with an insecticide
and insect repellent as needed, including dedicated overalls and boots
must be provided to prevent the introduction of potential vector
organisms from outside.
Medical waste and biohazardous material must be double bagged and
sprayed with insecticide prior to removal from the facility. SOPs for
the disposal of waste on site or (e.g. incineration) or removal by an
approved hazardous waste removal company must be available.
3.
Feed
Hay that might introduce insects or their larvae must be treated by an
approved method by submerging in water for a minimum of 10 minutes, by
heat treatment at 60°C for one minute or by fumigation, to reduce the
risk of introducing potential vectors.
4.
Access control
The facility site must not be publically accessible and entrance into
the facility must be restricted to authorised personnel and monitored.
No visitors should are allowed entry when infection experiments are
underway.
5.
Waste control
Normal waste (not including medical or biohazardous) and manure should
not be kept inside the facility. All solid waste must be removed and
disposed of away from the facility as odours will act as insect
attractants. Hazardous waste must be double bagged, disinfected,
sprayed with an insecticide and incinerated or removed by an
authorised waste contractor for incineration.
6.
Vector control and surveillance
Insecticides and repellents, selected for effectiveness against
specific target species, must be used on inner and outer surfaces of
the facility and on outer protective clothing of workers. Automatic
aerosol insecticide dispensers must be operated inside the facility
and ante rooms together with UV light electric insect killers. Insect
numbers inside and outside the facility must be monitored with UV
light insect traps (OVI Light trap for Culicoides)
7.
Equipment service and maintenance
All air handling and conditioning equipment should be inspected and
serviced on a yearly basis as prescribed by an accredited servicing
company at least annually by a certified technical person. The backup
power supply should be tested at least twice a year.
8.
Veterinary care
Routine health monitoring must be performed by SAVC registered or
authorised personnel. A veterinarian must be available for services
pertaining specially to the veterinary profession, including, but not
limited to the diagnosis and therapy of sick or injured animals.
Dedicated, trained staff must be identified to monitor and take care
of basic day-to-day animal care including feeding, watering and
cleaning.
5.
Record Keeping
The following approvals, activities and procedures should be
documented and kept at the facility:
1.
Facility approval and registration documentation, including
inspection reports
2.
Work performed with pathogens including Section 20 approvals
3.
Records for all animals arriving or leaving the facility
4.
Records of staff and visitor access to the facility, including
date and time
5.
All SOPs
6.
Training records for SOPs, safety and emergency procedures
7.
Maintenance and service records for equipment
PART III
Procedure for the registration of a vector protected facility
1.
Registration / Approval by Veterinary Authority
An application must be submitted to the Department of Agriculture (DAFF/DALRRD)
using the form in Annex I. Once the facility and documentation are
ready, arrangements can be made for inspection by a responsible
delegate from the Department. After inspection a recommendation report
will be provided if the application is approved.
2.
Required documents to be submitted on application as a vector
protected facility
1.
Application form (Annex I)
2.
Site plan
3.
Detailed plan of the facility
4.
SOPs (described in Annex II)
5.
Inspection report
Annex I, Application form
…
Annex II, Topics to be covered in facility SOPs
1.
Staff entry and exit, including access control and record keeping
2.
Entry and exit of animals and carcasses
3.
Feed and general waste handling
4.
Biosecurity and biohazardous waste handling
5.
Vector control and monitoring inside and outside
6.
Emergency evacuation of people and animals
7.
Monitoring of temperature and pressure
8.
Storage and handling of pathogens
9.
Procedure for donning on and off PPE including decontamination
before re-use
10.
SOPs for all Biosecurity measures
1.
Insecticide treatment of inside and outside surfaces of
building and mesh screens.
2.
Washing and treatment of dedicated cover-all’s and other PPE
3.
Storage, disinfection and disposal of Medical and biohazardous
waste
9 | Page
STANDARDS FOR THE DESIGN AND OPERATION OF VECTOR PROTECTED FACILITIES
FOR THE KEEPING OF
ANIMALS FOR EXPERIMENTAL INFECTIONS WITH VECTOR-BORNE ANIMAL PATHOGENS