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Pursuant to Republic Act No. 8485, otherwise known as the “Animal Welfare Act of 1998”, the following rules and regulations are hereby promulgated for the information, guidance and compliance of all concerned:

Section 1.      Introduction

1.1       The purpose of these rules and regulations is to institute the basic systems, organizations and practices in all laboratory animal care and use establishments to safeguard the welfare of animals used in scientific procedures. The intention is to grant authorization to conduct scientific procedures. The intention is to grant authorization to conduct scientific procedures using animals to any concerned entity based mainly on the acceptability of their Animal Care and Use Program and the existence of an Institutional Animal Care and Use Committee (IACUC). There is no intention to evaluate or review individual scientific procedures or protocols at the Animal Welfare Committee level. Such evaluation or review is best assumed by the IACUC in adherence to the principles of self-regulation.

1.2       Applicable guidelines and principles including: (1) Guide for the Care and Use of Laboratory Animals, Institute of Laboratory Animal Resources, National Research Council, USA; (2) PALAS Code of Practice for the Care and Use of Laboratory Animals in the Philippines, and (3) The International Guiding Principles for Biomedical Research Involving Animals, Council for International Organizations of Medical Sciences, are considered as support documents. From time to time, additional guidance may be issued on specific issues. A Guide for Institutional Animal Care and Use Committees (ANNEX A) is an integral part of this document.

1.3       The following shall be exempted form the requirements:

1.3.1 A clinical test on animals for evaluating a veterinary product in accordance with regulatory requirements or standard procedures.

1.3.2 The conduct of recognized veterinary procedures such as any therapy, prophylaxis, diagnostic or disease surveillance procedures directly necessary or desirable for the welfare of the animal or animal population. Examples are:

•           giving established medicines (e.g., antibiotics, anthelmintics, analgesics) orally or by injection
•           anesthetizing or sedating prior to further therapy (e.g., surgery) or diagnostic evaluation (e.g., x-ray)
•           performing corrective surgical procedures
•           vaccinating against rabies, distemper or other infectious diseases
•           taking blood or other tissue samples for diagnosis/disease testing.

1.3.3 The conduct or recognized agricultural practices such as castration, genetic engineering or embryo manipulation, unless they form part of an experiment.

Section 2.      Definition of Terms . — For purposes of these rules and regulations, the following definitions shall apply:

2.1       Animal refers to any live vertebrate animal, whether in a domestic or wild state, which is used or intended for use in scientific procedures.

2.2       Scientific Procedures refer to any activity which entails manipulation of animals for the following purposes:

a)      biomedical researches, experiments, studies, or investigations
b)      teaching and instruction
c)      product (food, drugs, agrochemicals and cosmetics) testing
d)      production of antisera or other biologicals

2.3     Manipulation refers to interfering with the normal physiological, behavioral or anatomical integrity of the animal by deliberately:

a)      exposing it to any parasite, microorganism, drug, chemical, biological product, radiation, electrical stimulation, or environmental condition;

b)      subjecting it to enforced activity, unusual restraint, abnormal nutrition or surgical procedures;

c)      depriving it of usual care.

These may have the effect of causing an animal pain, suffering, distress or lasting harm. These terms include death, disease, injury, physiological or psychological stress, significant discomfort or any disturbance to normal health, whether immediately or in the long term.

Section 3.        Authorization/Registration/Certification

3.1       Any private or government entity (i.e., person, partnership, organization, establishment, firm, cooperative, corporation, association including medical, dental, allied, research, academic and/or scientific institutions) must secure from the Bureau of Animal Industry, Department of Agriculture, Authorization to conduct scientific procedures using animals.

3.2       Application for Authorization or renewal thereof shall be made by the entity in such form and manner as may be prescribed from time to time by regulations.

3.3       A processing fee of P100.00 shall be paid upon application.

3.4       The revocation of the authorization of any entity may be appealed to the Animal Welfare Committee.

Section 4.      Requirements for Authorization. — The entity shall be required to submit a duly accomplished “Application for Authorization” form (ANNEX B) accompanied by the following documents:

4.1       Description of the Animal Care and Use Program (ACUP) (ANNEX C) signed by the duly licensed veterinarian representing the entity.

4.2       Animal Care and Use Program Accreditation Certificate issued by a duly recognized body or association such as the Philippine Association for Laboratory Animal Science (PALAS).

4.3       Animal Technician Training Program on laboratory animal care and use.

4.4       Certification of Assurance that an Institutional Animal Care and Use Committee (IACUC) is in existence in the establishment.

The IACUC shall be composed of at least three (3) members:

•        a licensed veterinarian (preferably with sufficient training and experience in laboratory animal science or medicine or in the use of the species in question)
•        one experienced in scientific procedures involving animals
•        a public member not affiliated with the institution and preferably with concern for animal welfare
•        any additional members may be appointed provided he/she possesses the aforementioned qualifications.

The functions and obligations of the IACUC shall be to:

•        evaluate and approve the ACUP and the protocols of scientific procedures
•        monitor and review the implementation of the ACUP and scientific procedures through the conduct of facility inspections
•        submit an annual report on the status and implementation of the ACUP to the BAI.

Section 5.      Renewal of Authorization

5.1       The Authorization shall be valid for 2 years and is renewable thereafter. Renewal shall be based on a Compliance Evaluation of the entity.

5.2       Application for renewal of the Authorization shall be made at least 1 month prior to the expiration of the Authorization.

Section 6.      Euthanasia . — Euthanasia is defined as the process of inducing painless death to pets. It has rapidly gained acceptance in many aspects of scientific procedures. It should be done rapidly and humanely and must occur with the least fear, anxiety, pain and distress to the animals. Consideration must be given to how the animal is handled immediately prior to and during the procedure.

The euthanasia of animals should always be done away from public view.

6.1       Carbon Dioxide (CO₂)

•        Satisfactory for several species if used in an uncrowded chamber ——> safe, humane, economical, rapid
•        relatively safe for operator but must be used in a well-ventilated room
•        favored when investigators want to avoid the use of chemicals on animals and if a large number of animals are to be sacrificed
•        available locally/commercial; initial expense may be high since the gas cylinder may have to be purchased but some companies loan out the cylinders; gas gauge not necessary but cylinder must be fitted with valves for control of gas release
•        should be at least 40% concentration (commercial grade is 99%)
•        Since (CO₂) is heavier than air, opening should be on top; container may be a specially constructed lethal chamber or a simple plastic bag
•        filling container first before placing animals inside may improve efficiency
•        dry ice may also be used but contact between the animals and the ice must be avoided

6.1.1 Small rodents (mice, rats, hamsters, guinea pigs)

•        CO₂ is ideal for rodents since several animals can be euthanatized at the same time
•        animals are placed in a large chamber or plastic bag which is subsequently filled with CO₂
•        newborn may be more resistant than adults

6.1.2 Rabbits

•        concentrations of 40-100% are safe and effective

6.1.3 Dogs and Cats

•        concentration should at least be 40% preferably 70%
•        some stress may be encountered depending on the means of delivery and the concentration within the chamber
•        very suitable for cats which become unconscious within 90 seconds and die in 5 minutes in concentrations less than 60%
•        animal(s) should remain in the container for 20 minutes after respiratory arrest to ensure death
•        only one adult cat or dog should be euthanatized in the enclosure at one time

6.1.4 Primates

•        euthanatized in a lethal chamber or with mask or cone
•        (CO₂) may be used alone or following ketamine and/or general anesthetic agents

6.2       Other Inhalation Anesthetics

6.2.1 Halothane, Methoxyflurane – may be too expensive

6.2.2 Ether — inexpensive but flammable/explosive cotton is soaked with ether then placed inside an ether jar or other suitable tightly sealed container; wire mesh is placed over the cotton to prevent contact between animal and ether; animal is then placed in the container which is then tightly shut. Unsatisfactory because death is prolonged.

6.2.3 Chloroform — NOT recommended any more: CARCINOGENIC

6.3       Barbiturates

•        sodium pentobarbital (pentobarbitone) most commonly used
•        controlled substance

6.3.1 Rodents

•        IP route easier and faster; IV route more difficult and time-consuming
•        intrathoracic and intracardiac methods may be painful and are recommended only in animals already sedated

6.3.2 Rabbits

•        IV route is first choice if aural veins are to be used
•        Intracardiac may be painful or slow if injection is made into pericardial space; may be useful if animal is already under anesthesia
•        sodium pentobarbital is humane, safe, and efficient but consideration should be given to the chemical burden

6.3.3 Dogs and Cats

•        sodium pentobarbital at three times the anesthetic dose should ensure respiratory and subsequent cardiac arrest in dogs and cats
•        this drug by the IV route is the most recommended means of producing in dogs and cats
•        premedication with sedative drugs by IM or SC routes facilitates restraint for IV injection
•        IP injection is reserved for fractious animals
•        intracardiac injection can be used in dogs already anesthetized, or by skilled personnel in unanesthetized animals
•        some euthanatizing agents (T-61R or ButhanasiaR) may be available commercially

6.3.4 Primates

•        injected by IP or IV route while animal is being held or restrained in squeeze cage
•        premedication with IM or SC administration of ketamine hydrochloride facilitates the procedure
•        may be combined with other anesthetic agents

6.4       Cervical or Cranial Concussion (Stunning)

•        requires skill to be effective and humane

6.4.1 Rodents

•        guinea pigs may be stunned with a sharp blow to the back of the neck; this procedure usually followed by exsanguination, thoracotomy, etc.
•        suitable also for mice and other small animals
•        rats may be wrapped in a small towel prior to striking them behind the head or against a sink or table; primarily used in young rats

6.4.2 Rabbits

•        involves striking the rabbit behind the head with a wooden or metal object or the heel of the hands in a karate blow (rabbit punch)
•        used when drug is contraindicated; avoids exogenous drugs but prevents histological studies of the brain
•        objectionable to some individuals for esthetic reasons
•        requires skill and does not assure death
•        followed by decapitation, thoracotomy, or exsanguination

6.5       Cervical Dislocation

•        requires skills to be effective and human

6.5.1 Rodents

•        very satisfactory in mice, can be used for other animals weighing less than 250 gm., e.g. young rats; used only if a few mice are to be sacrificed
•        thumb, first finger, a pencil, a piece of wood, or metal object is placed against the back of the neck and pressed down against a firm surface such as a table top to produce the dislocation; pressure is applied to the neck at the same time tail is pulled firmly and suddenly; the thoracic vertebrae may also be dislocated
•        hamsters and guinea pigs are more difficult to euthanatize by this method due to their short necks, stronger neck muscles, and loose skin over the neck and shoulders; an alternate method consists of grasping them over the head from the cranial direction and/or giving the body a quick snap as a whip.

6.5.2 Rabbits

•        rabbits weighing less than 1 kg can be held by the legs at the waist with one hand, while the head is held in the other and the neck is overextended
•        the technique may also be used while the rabbit is held in lateral recumbency on a table or flat surface

6.6       Decapitation

•        performed with the use of guillotine
•        unpleasant and dangerous to the operator but useful for pharmacological studies or for special studies in which drugs are contraindicated
•        objectionable to many people
•        equipment must be thoroughly cleaned before the next animal is decapitated
•        head must be completely served from the body
•        more difficult to use in guinea pigs, hamsters, and mice than in rats; also used in rabbits

6.7       Exsanguination

•        used in animals (usually rabbits and guinea pigs) that have high titers of antibodies
•        performed only AFTER anesthetization
•        isolation of the carotid artery or venipuncture via the intracardiac route are means of withdrawing blood

6.8       Air by the Intravenous Route

•        5-50mL/kg produces rapid death that may be accompanied by convulsions, opisthotonos, pupillary dilatation, and vocalization
•        mostly used in rabbits
•        NOT recommended in unanesthetized animals

6.9       Chloral Hydrate and Magnesium Sulfate

•        given IV to cats and dogs to effect; animals MUST be sedated first

6.10    Ethanol 70%

•        for use in mice and rats only; 70% concentration is usually used
•        initially proposed by Dr. Roger Lord of the Queensland (Australia) Institute of Medical Research, Herston, Queensland [CCAC Research 16(1); 1991, 1992 – January]
•        mode of action: works as a depressant like (CO₂)
•        humane, inexpensive, very simple – Dr. Lord
•        may be utilized in instances where barbiturate drugs are normally used
•        readily available
•        injected intraperitoneally

Section 7.      Administrative Sanctions

7.1       Authorization shall be revoked under the following conditions:

7.1.1 Failure to subscribe to or conduct the Animal Technician Training Program

7.1.2 Misrepresentation of any material fact in the animal care and use program description and the reports of the ACUC

7.2       Re-application after revocation. An entity whose Authorization was revoked can only re-apply for Authorization after one (1) year from the date of revocation.

Section 8.      Separability Clause . — In case any provision of these rules and regulations is declared to be contrary to law or unconstitutional, the other provisions that are not affected shall thereby remain valid and effective.

Section 9.      Repealing Clause . — All Administrative Orders, rules and regulations and other Administrative issuances or parts thereof, inconsistent with the provisions of this Administrative Order, are hereby repealed or modified accordingly.

Section 10.    Transitory Provision/Grace Period . — The current conduct of scientific procedures using animals shall be allowed pending the establishment of the infrastructures and mechanisms for authorization/registration/certification and until the issuance of a denial of authorization with reference to the initial application for authorization.

Section 11.    Effectivity. — This Order shall take effect fifteen (15) days after its publication in a newspaper of general application.

Adopted: 02 Aug. 1999

(SGD.) EDGARDO J. ANGARA Secretary
Recommending Approval:
(SGD.) ENRIQUE T. CARLOS (PVMA) Chairman	(SGD.) TEODORO A. ABILAY (BAI) Vice-Chairman
Members:
(SGD.) EDGARDO C. DIMALANTA  National Meat Inspection Commission	(SGD.) ADOLFO R. ACORDA Philippine College of Swine Practitioners
(SGD.) NORMA M. MOLINYAWE  Protected Areas and Wildlife Bureau	(SGD.) ABELARDO B. AGULTO Philippine College of Canine Practitioners
(SGD.) CONRADO A. FRANCISCO  Philippine Society for the Prevention of Cruelty to Animals of the Philippines	(SGD.) ARWINIE A. SERRANO  Veterinary Practitioners Association
(SGD.) JOSE V. VALENZUELA  Philippine Society of Animal Science	(SGD.) MENANDRO C. VALERIO  Philippine Animal Hospital Association
(SGD.) ELEANOR R. JAVIER  Department of Education, Culture & Sports	(SGD.) EULOGIO R. MAGSAYSAY  by MANUEL M. PABLO Department of Interior & Local Government

Note:

1)         Annexes are available at Office of the National Administrative Register, U.P. Law Center, Diliman , Quezon City.

2)         This Administrative Order No. 40, s. 1999 was also filed by the Department of Agriculture on 30 June 2000.