Animals and Birds (Care and Use of Animals for Scientific Purposes) Rules

These Rules may be cited as the Animals and Birds (Care and Use of Animals for Scientific Purposes) Rules.

In these Rules, unless the context otherwise requires —

“animal” means any live vertebrate, including any fish, amphibian, reptile, bird and mammal but shall not include any human being;

“approved project” means any project that involves the use of any animal for any scientific purpose and that is approved by an institutional animal care and use committee;

“attending veterinarian” means a veterinarian employed by a licensee under rule 11;

“designated member of the committee” means a designated member of an institutional animal care and use committee;

“experiment” may consist of one or more separate procedures;

“guidelines” means guidelines issued or adopted by the Director-General under rule 18;

“institutional animal care and use committee” means a committee appointed by a licensee under rule 7;

“investigator” means a person who proposes, or is approved by an institutional animal care and use committee, to conduct an approved project;

“licence” means a licence issued by the Director-General under rule 4;

“licensee” means a person who holds a valid licence;

“personnel”, in relation to a research facility, means all the persons involved in the housing, feeding and general care or use of the animals, or who otherwise assist investigators, in the research facility;

“premises” includes the facilities, buildings, yards, paddocks, grounds and equipment therein;

“project” means an experiment or a series of related experiments that form a discrete piece of work or research for any scientific purpose;

“proposal” means a written outline of a project put forward for the consideration of an institutional animal care and use committee;

“proposal assigned for DMR” means any proposal that is assigned by an institutional animal care and use committee to be reviewed by designated members of the committee;

“research facility”, in relation to a licensee, means all the premises which belong to the licensee and which are approved by the Director-General under the licence for the keeping or use of animals for scientific purposes;

“scientific purpose” means any purpose for which activities (including special breeding requirements integral to a research or teaching project) are performed to acquire, develop or demonstrate knowledge or techniques in any scientific discipline, including the purpose of research, teaching, diagnosis, field trials, product testing, production of biological products and environmental studies;

“veterinarian” means a person with qualifications in veterinary science who is licensed by the Director-General under section 53 of the Act.

For the purposes of these Rules, a person shall be treated as keeping or using animals in his research facility or premises for a scientific purpose if he allows any person to use his research facility or premises for such purpose.

No person, being the owner or occupier or having the management or control of any premises, shall keep or use, or allow any person to keep or use, any animal in those premises for any scientific purpose unless —

he holds a licence issued by the Director-General under these Rules authorising him to do so;

the keeping or use of any animal in those premises for any scientific purpose is carried out in accordance with the conditions of the licence;

the licensee has, in accordance with rule 7, appointed an institutional animal care and use committee and the project involving the keeping or use of the animal for the scientific purpose has been approved by the committee; and

the licensee has, in accordance with rule 11, employed an attending veterinarian.

An application for a licence shall be made to the Director-General in such form or manner as the Director-General may require and shall be accompanied by —

the appropriate fee as specified in the Schedule; and

such particulars, information and documents as may be specified by the Director-General.

Subject to paragraphs (3) and (4), the Director-General may, on receipt of an application under paragraph (1) —

issue a licence to the applicant, whether unconditionally or subject to such conditions as he thinks fit to impose; or

refuse to issue any licence to the applicant.

The Director-General shall not issue a licence to an applicant unless —

the applicant is —

carrying on business in Singapore and is registered under the Business Registration Act (Cap. 32);

a company incorporated or registered under the Companies Act (Cap. 50);

a statutory body established by or under any written law; or

an institution of higher learning;

the functions or course of business of that person involves activities for scientific purposes; and

the Director-General is satisfied that the premises in respect of which the licence is being applied for are suitable for the keeping or use of animals for scientific purposes.

In determining whether to issue or refuse to issue a licence, the Director-General may consider —

the character and fitness of the applicant to be issued with a licence or, where the applicant is a body corporate, the character and fitness of the members of the board of directors or management committee or board of trustees or other governing body of the body corporate; and

the ability of the applicant to operate and maintain the relevant premises in accordance with the requisite conditions and guidelines.

For the purposes of paragraph (3)(c), the Director-General may, at any time —

enter and inspect the premises in respect of which the application is made, or cause such premises to be inspected by an authorised officer; and

require the applicant, at his own expense, to make such alteration or improvement to such premises or to provide, fix or install such facilities and equipment as the Director-General may specify.

The Director-General may refuse to issue a licence to an applicant if —

the applicant or one of his partners or, if the applicant is a body corporate, one of its directors —

had previously been convicted of an offence under the Act; or

had previously held a licence issued under the Act and the licence was subsequently suspended or revoked under section 62 of the Act;

in the opinion of the Director-General, the applicant —

is not able to operate and maintain the relevant premises in accordance with the requisite conditions and guidelines; or

is otherwise not a fit and proper person to be issued a licence;

in the opinion of the Director-General, the premises in respect of which the licence is being applied for are not suitable for the keeping or use of animals for scientific purposes;

the applicant has not appointed, or has not undertaken to appoint, an institutional animal care and use committee in accordance with rule 7; or

the applicant has not employed, or has not undertaken to employ, an attending veterinarian in accordance with rule 11.

The Director-General may, at any time, vary or revoke any of the conditions imposed under paragraph (2)(a) or impose new conditions.

Every licence issued under this rule —

shall be in such form as the Director-General may determine;

shall be valid for the period stated therein unless it is revoked under section 62 of the Act; and

may be renewed upon its expiry.

Where the Director-General refuses to issue a licence under paragraph (2)(b), he shall, if requested to do so by the applicant, state in writing the reasons for his refusal.

Paragraphs (1) to (9) shall apply, with the necessary modifications, to an application for the renewal of a licence.

An application for a licence shall be made to the Director-General in such form or manner as the Director-General may require and shall be accompanied by —

the appropriate fee as specified in the Schedule; and

such particulars, information and documents as may be specified by the Director-General.

Subject to paragraphs (3) and (4), the Director-General may, on receipt of an application under paragraph (1) —

issue a licence to the applicant, whether unconditionally or subject to such conditions as he thinks fit to impose; or

refuse to issue any licence to the applicant.

The Director-General shall not issue a licence to an applicant unless —

the applicant is —

carrying on business in Singapore and is registered under the Business Registration Act (Cap. 32);

a company incorporated or registered under the Companies Act (Cap. 50);

a statutory body established by or under any written law; or

an institution of higher learning;

the functions or course of business of that person involves activities for scientific purposes; and

the Director-General is satisfied that the premises in respect of which the licence is being applied for are suitable for the keeping or use of animals for scientific purposes.

In determining whether to issue or refuse to issue a licence, the Director-General may consider —

the character and fitness of the applicant to be issued with a licence or, where the applicant is a body corporate, the character and fitness of the members of the board of directors or management committee or board of trustees or other governing body of the body corporate; and

the ability of the applicant to operate and maintain the relevant premises in accordance with the requisite conditions and guidelines.

For the purposes of paragraph (3)(c), the Director-General may, at any time —

enter and inspect the premises in respect of which the application is made, or cause such premises to be inspected by an authorised officer; and

require the applicant, at his own expense, to make such alteration or improvement to such premises or to provide, fix or install such facilities and equipment as the Director-General may specify.

The Director-General may refuse to issue a licence to an applicant if —

the applicant or one of his partners or, if the applicant is a body corporate, one of its directors —

had previously been convicted of an offence under the Act; or

had previously held a licence issued under the Act and the licence was subsequently suspended or revoked under section 62 of the Act;

in the opinion of the Director-General, the applicant —

is not able to operate and maintain the relevant premises in accordance with the requisite conditions and guidelines; or

is otherwise not a fit and proper person to be issued a licence;

in the opinion of the Director-General, the premises in respect of which the licence is being applied for are not suitable for the keeping or use of animals for scientific purposes;

the applicant has not appointed, or has not undertaken to appoint, an institutional animal care and use committee in accordance with rule 7; or

the applicant has not employed, or has not undertaken to employ, an attending veterinarian in accordance with rule 11.

The Director-General may, at any time, vary or revoke any of the conditions imposed under paragraph (2)(a) or impose new conditions.

Every licence issued under this rule —

shall be in such form as the Director-General may determine;

shall be valid for the period stated therein unless it is revoked under section 62 of the Act; and

may be renewed upon its expiry.

Where the Director-General refuses to issue a licence under paragraph (2)(b), he shall, if requested to do so by the applicant, state in writing the reasons for his refusal.

Paragraphs (1) to (9) shall apply, with the necessary modifications, to an application for the renewal of a licence.

No licensee shall transfer or assign the benefit of his or its licence to any other person.

Every licensee shall ensure that the handling, care and treatment of any animal used for any scientific purpose in his or its research facility, including the transportation of such animal to and from the research facility, conforms to —

the provisions of these Rules;

the conditions of his or its licence issued under rule 4; and

the relevant guidelines issued or adopted, and the relevant directives issued, by the Director-General under rule 18.

Every licensee shall, within such time and in such manner as the Director-General may require, inform the Director-General of any change to the operations or personnel of his or its research facility.

Every licensee shall ensure that the handling, care and treatment of any animal used for any scientific purpose in his or its research facility, including the transportation of such animal to and from the research facility, conforms to —

the provisions of these Rules;

the conditions of his or its licence issued under rule 4; and

the relevant guidelines issued or adopted, and the relevant directives issued, by the Director-General under rule 18.

Every licensee shall, within such time and in such manner as the Director-General may require, inform the Director-General of any change to the operations or personnel of his or its research facility.

Every licensee shall appoint an institutional animal care and use committee in relation to his or its research facility.

The appointment of an institutional animal care and use committee shall be made before the licensee keeps or uses any animal in his or its research facility for any scientific purpose.

Subject to this rule, every institutional animal care and use committee appointed under paragraph (1) shall comprise at least 5 members, including one member from each of the following categories:

a veterinarian with training or experience in laboratory animal science and medicine and who has experience in the routine care of the species of animals used in the research facility;

a person with appropriate experience in the use of animals for scientific purposes;

a person who —

is not affiliated in any way with the licensee;

is not a member of the immediate family of any person who is affiliated with the licensee; and

is not a user of any animal for any scientific purpose; and

a person whose primary concerns or interests are in non-scientific areas.

Notwithstanding paragraph (3), no person shall be appointed as a member of an institutional animal care and use committee unless he is suitably qualified in accordance with such requirements as may be specified by the Director-General.

The attending veterinarian employed by a licensee under rule 11 shall be appointed as a member of the institutional animal care and use committee of the licensee.

The licensee or, where the licensee is a body corporate, the chief executive officer or other similar officer of the licensee, shall not be appointed as a member of the institutional animal care and use committee of the licensee.

The Chairman of the institutional animal care and use committee of a licensee shall be appointed by the licensee from amongst the members of the institutional animal care and use committee.

The licensee shall, before appointing any person as a member of an institutional animal care and use committee, notify the Director-General of the particulars of that person, including his name, address and occupation, the proposed date of his appointment, the term of his appointment and such other particulars as the Director-General may require.

The Director-General may at any time —

object to the appointment of a person as a member of an institutional animal care and use committee; or

where the person is already a member of the institutional animal care and use committee, require the licensee who appointed that person as a member of the institutional animal care and use committee to remove that person from the committee and appoint another person in his place.

When any member of the institutional animal care and use committee appointed by a licensee ceases to hold office for any reason, the licensee shall notify the Director-General thereof within such time and in such manner as the Director-General may require.

Every licensee shall appoint an institutional animal care and use committee in relation to his or its research facility.

The appointment of an institutional animal care and use committee shall be made before the licensee keeps or uses any animal in his or its research facility for any scientific purpose.

Subject to this rule, every institutional animal care and use committee appointed under paragraph (1) shall comprise at least 5 members, including one member from each of the following categories:

a veterinarian with training or experience in laboratory animal science and medicine and who has experience in the routine care of the species of animals used in the research facility;

a person with appropriate experience in the use of animals for scientific purposes;

a person who —

is not affiliated in any way with the licensee;

is not a member of the immediate family of any person who is affiliated with the licensee; and

is not a user of any animal for any scientific purpose; and

a person whose primary concerns or interests are in non-scientific areas.

Notwithstanding paragraph (3), no person shall be appointed as a member of an institutional animal care and use committee unless he is suitably qualified in accordance with such requirements as may be specified by the Director-General.

The attending veterinarian employed by a licensee under rule 11 shall be appointed as a member of the institutional animal care and use committee of the licensee.

The licensee or, where the licensee is a body corporate, the chief executive officer or other similar officer of the licensee, shall not be appointed as a member of the institutional animal care and use committee of the licensee.

The Chairman of the institutional animal care and use committee of a licensee shall be appointed by the licensee from amongst the members of the institutional animal care and use committee.

The licensee shall, before appointing any person as a member of an institutional animal care and use committee, notify the Director-General of the particulars of that person, including his name, address and occupation, the proposed date of his appointment, the term of his appointment and such other particulars as the Director-General may require.

The Director-General may at any time —

object to the appointment of a person as a member of an institutional animal care and use committee; or

where the person is already a member of the institutional animal care and use committee, require the licensee who appointed that person as a member of the institutional animal care and use committee to remove that person from the committee and appoint another person in his place.

When any member of the institutional animal care and use committee appointed by a licensee ceases to hold office for any reason, the licensee shall notify the Director-General thereof within such time and in such manner as the Director-General may require.

With respect to activities involving animals in the research facility of a licensee, the functions and duties of the institutional animal care and use committee appointed by the licensee under rule 7 shall be as follows:

to review, at least once every 12 months, all programmes for the care and use of animals carried out in the research facility, using the guidelines as a basis of evaluation;

to inspect the research facility, including the housing facilities for animals, at least once annually, using the guidelines as a basis of evaluation;

to prepare reports of the evaluations conducted by the committee in accordance with such requirements as may be set out in the guidelines and submit the reports directly to the licensee;

to review and investigate any concern, complaint or report of non-compliance with any guideline involving the care and use of any animal at the research facility;

to make recommendations to the licensee regarding any aspect of the animal programme, facilities or personnel training at the research facility;

to review, approve, require modifications in, withhold approval of or reject any proposed project, or any proposed significant change in any ongoing project, relating to the use of any animal for any scientific purpose;

to withdraw approval for or suspend any project involving any animal if that project is not being conducted in accordance with the guidelines or with the description thereof provided by the investigator and approved by the committee;

to authorise the treatment or humane killing of any animal for any scientific purpose;

to conduct continuing reviews of activities involving the use of any animal for any scientific purpose, including any approved project of long duration and any long-term continual use of any individual animal for such purpose, at appropriate intervals but at least once a year;

to determine the best means of conducting an evaluation of the care and use of animals, provided that no member of the institutional animal care and use committee wishing to participate in any evaluation is excluded;

to maintain a register of approved projects; and

to perform all duties as required under the guidelines.

An institutional animal care and use committee may invite ad hoc consultants to assist it in conducting an evaluation under paragraph (1)(a), except that the institutional animal care and use committee shall remain responsible for such evaluation and the report thereon.

With respect to activities involving animals in the research facility of a licensee, the functions and duties of the institutional animal care and use committee appointed by the licensee under rule 7 shall be as follows:

to review, at least once every 12 months, all programmes for the care and use of animals carried out in the research facility, using the guidelines as a basis of evaluation;

to inspect the research facility, including the housing facilities for animals, at least once annually, using the guidelines as a basis of evaluation;

to prepare reports of the evaluations conducted by the committee in accordance with such requirements as may be set out in the guidelines and submit the reports directly to the licensee;

to review and investigate any concern, complaint or report of non-compliance with any guideline involving the care and use of any animal at the research facility;

to make recommendations to the licensee regarding any aspect of the animal programme, facilities or personnel training at the research facility;

to review, approve, require modifications in, withhold approval of or reject any proposed project, or any proposed significant change in any ongoing project, relating to the use of any animal for any scientific purpose;

to withdraw approval for or suspend any project involving any animal if that project is not being conducted in accordance with the guidelines or with the description thereof provided by the investigator and approved by the committee;

to authorise the treatment or humane killing of any animal for any scientific purpose;

to conduct continuing reviews of activities involving the use of any animal for any scientific purpose, including any approved project of long duration and any long-term continual use of any individual animal for such purpose, at appropriate intervals but at least once a year;

to determine the best means of conducting an evaluation of the care and use of animals, provided that no member of the institutional animal care and use committee wishing to participate in any evaluation is excluded;

to maintain a register of approved projects; and

to perform all duties as required under the guidelines.

An institutional animal care and use committee may invite ad hoc consultants to assist it in conducting an evaluation under paragraph (1)(a), except that the institutional animal care and use committee shall remain responsible for such evaluation and the report thereon.

Where the Director-General is of the opinion that the institutional animal care and use committee of a licensee is not discharging its functions in a proper or satisfactory manner, the Director-General may order the licensee to —

remove or replace any member of the institutional animal care and use committee; or

dissolve that institutional animal care and use committee and appoint a new institutional animal care and use committee in its place.

Until the licensee has complied with any order given by the Director-General under paragraph (1) —

the licensee shall ensure that no animal is kept or used by any person for any scientific purpose in the research facility of the licensee unless otherwise allowed by the Director-General and subject to such conditions as the Director-General may impose; and

the Director-General may, if he thinks necessary, suspend the licence of the licensee.

For the purposes of paragraph (1), an institutional animal care and use committee is not discharging its functions in a proper or satisfactory manner if the committee fails to comply with —

any provision of these Rules; or

any guidelines issued or adopted, or any directives issued, by the Director-General under rule 18.

Where the Director-General is of the opinion that the institutional animal care and use committee of a licensee is not discharging its functions in a proper or satisfactory manner, the Director-General may order the licensee to —

remove or replace any member of the institutional animal care and use committee; or

dissolve that institutional animal care and use committee and appoint a new institutional animal care and use committee in its place.

Until the licensee has complied with any order given by the Director-General under paragraph (1) —

the licensee shall ensure that no animal is kept or used by any person for any scientific purpose in the research facility of the licensee unless otherwise allowed by the Director-General and subject to such conditions as the Director-General may impose; and

the Director-General may, if he thinks necessary, suspend the licence of the licensee.

For the purposes of paragraph (1), an institutional animal care and use committee is not discharging its functions in a proper or satisfactory manner if the committee fails to comply with —

any provision of these Rules; or

any guidelines issued or adopted, or any directives issued, by the Director-General under rule 18.