Title
Rules on Animal Scientific Procedures
Law
Bai Administrative Order No. 40-99
Decision Date
Aug 2, 1999
BAI Administrative Order No. 40-99 establishes regulations for the ethical conduct of scientific procedures involving animals, requiring entities to secure authorization based on their Animal Care and Use Program and the oversight of an Institutional Animal Care and Use Committee (IACUC) to ensure animal welfare.

Exemptions

  • Clinical tests for veterinary products under regulatory standards.
  • Recognized veterinary procedures related to animal welfare (e.g., administration of medicines, anesthesia, surgery).
  • Recognized agricultural practices unless part of experiments.

Key Definitions

  • "Animal": Any live vertebrate used or intended for scientific procedures.
  • "Scientific Procedures": Activities involving animals for research, teaching, product testing, or biological production.
  • "Manipulation": Interference with normal physiological or anatomical integrity that may cause pain, distress, or harm.

Authorization and Registration Requirements

  • Entities (private or government) must secure authorization from the Bureau of Animal Industry (BAI) to conduct scientific procedures.
  • Application includes form submission, compliance documents, and a P100 processing fee.
  • Authorization revocation may be appealed to the Animal Welfare Committee.

Authorization Requirements

  • Submit Application for Authorization with:
    • Description of ACUP signed by a licensed veterinarian.
    • Accreditation Certificate from recognized bodies like PALAS.
    • Animal Technician Training Program certification.
    • Certification of an existing IACUC with at least three members including a veterinarian, a scientist experienced with animals, and a public member.
  • IACUC functions include:
    • Evaluating and approving ACUP and protocols.
    • Monitoring and reviewing ACUP implementation.
    • Reporting annually to BAI.

Renewal of Authorization

  • Valid for 2 years, renewable based on compliance evaluation.
  • Renewal application submitted at least one month before expiration.

Euthanasia Procedures

  • Euthanasia defined as painless humane death minimizing fear, pain, and distress.
  • Must be performed away from public view.

Accepted Methods of Euthanasia

  • Carbon Dioxide (CO2): Suitable for various species; requires proper concentration and ventilation.
  • Inhalation Anesthetics: Halothane and Methoxyflurane (expensive), Ether (flammable, unsatisfactory), Chloroform (not recommended).
  • Barbiturates (e.g., sodium pentobarbital): Preferred for dogs and cats, administered via various routes.
  • Cervical/Cranial Concussion: Requires skill; used for rodents and rabbits.
  • Cervical Dislocation: Humane method requiring skill; used in rodents and small rabbits.
  • Decapitation: Method for pharmacological studies; dangerous and aesthetically objectionable.
  • Exsanguination: Performed post-anesthesia mainly in rabbits and guinea pigs.
  • Air Intravenous Injection: Rapid death but not recommended for unanesthetized animals.
  • Chloral Hydrate and Magnesium Sulfate: For cats and dogs with sedation.
  • Ethanol 70%: For mice and rats; humane, inexpensive, intraperitoneal injection.

Administrative Sanctions

  • Authorization may be revoked for:
    • Failure to conduct training programs.
    • Misrepresentation of material facts.
  • Reapplication allowed only after one year from revocation.

Legal Provisions

  • Separability Clause: Invalidity of any provision does not affect others.
  • Repealing Clause: Inconsistent administrative orders and rules are repealed or modified.
  • Transitory Provision: Existing scientific procedures allowed until denial or authorization issuance.
  • Effectivity: Order effective 15 days after newspaper publication.

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