### USDA

- APHIS

- Animal Care
Animal Welfare Act Summary Changes to Policy #3

– Veterinary Care

Policy #3: Veterinary Care:

Expired Medical Material s Pharmaceutical

- Grade Compounds in Research Surgery

Pre

- and Post

- Procedural Care Program of Veterinary Care Declawing and Defanging Practices in Wild or Exotic
Carnivores or Nonhuman Primates
Health Records
Euthanasia Change to : Pharmaceutical

- Grade Substances in
Research

Issue Date: March 25, 2011 Change to : XXXXX, 2013

References:

AWA Section 2143 9 CFR, Part 2, Sections 2.31, 2.32, 2.33, 2.40 9 CFR, Part 3, Section 3.110 No Change

History: Replaces memoranda dated May 31, 1990; November 29, 1991; April 6, 1992; and September 25, 1992. Replaces policies dated April 14, 1997; January 14, 2000; August 18, 2006; and July 17, 2007. Add : September XXX , 2013

Justification: Provides requested guidance. The Animal Welfare Act (AWA) requires that all regulated animals be provided adequate veterinary care. No C hange

Policy: Expired Medical Materials

The use of expired medical materials such as drugs, fluids, or sutures on regulated animals is not considered to be acceptable veterinary practice and is not consistent with adequate veterinary care as required by the regulations promulgated under the Anim al Welfare Act. The facility should either dispose of all such materials or segregate them in an appropriately labeled, physically separate location from non

- expired medical materials. Change to:

The use of expired medical materials ( e.g ., drugs, fluids, sutures, anesthetics , or analgesics) during any surgical procedure is not considered acceptable veterinary practice and therefore not consistent with adequate veterinary care as required by the regulations promulgated under the Animal Welfare Act. However, expired
medical mat erials except analgesics, anesthetics, and euthanasia solutions may be used in acute terminal procedures where an animal is anesthetized during the study and euthanized without recovery if such use does not adversely



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### USDA

- APHIS

- Animal Care
Animal Welfare Act Summary Changes to Policy #3

– Veterinary Care

The Animal and Plant Health Inspection Service (APHIS),
Animal Care (AC) has no jurisdiction over facilities using expired medical materials for non

- regulated animals or

non

- regulated activities.

For acute terminal procedures, where an animal is put under anesthesia, the research is carried out (surgery or testing of a compound) and the animal is euthanized without ever waking up, medical materials may be used beyond their "to be used by" date if s uch materials use does not adversely affect the animal’s wellbeing or compromise the validity of the scientific study. Anesthesia, analgesia, emergency drugs and euthanasia drugs that are within their expiration dates are required for all such procedures. Facilities allowing the use of expired medical materials in acute terminal procedures should have a policy covering the use of such materials and/or require investigators to describe in their animal activity proposals the intended use of expired materials.

The attending veterinarian and the Institutional Animal Care and Use Committee (IACUC) are responsible for ensuring that proposed animal activities avoid or minimize discomfort, distress, and pain to the animal. APHIS has determined that these responsib ilities cannot
be met unless the veterinarian and the IACUC maintain control over the use of expired medical materials. affect the animal’s well

- being or compr omise the validity of the scientific study.

Facilities permitting the use of expired medical materials in acute terminal procedures should have a policy on the use of such materials and/or require investigators to describe the inte nded use in the animal study proposal.

The Animal and Plant Health Inspection Service/ Animal Care (APHIS/AC) has determined that the attending veterinarian along with the IACUC should control the use of expired medical materials in order to comply with t he regulatory requirement to ensure pain and distress is minimized during proposed activities.

Expired materials should be segregated from

non

- expired medical materials in an appropriately labeled, physically separate
location or discarded. APHIS however has no jurisdiction over the possession and use of expired medical materials for non

- regulated
animals and activities.

Pharmaceutical

- Grade Compounds in Research

Investigators are expected to use ph armaceutical

- grade medications whenever they are available, even in acute procedures. Non

- pharmaceutical

- grade chemical compounds should only be used in regulated animals after specific review and approval by the IACUC for
reasons such as scientific neces sity or non

- availability of an acceptable veterinary or human pharmaceutical

- grade product. Cost savings is not a justification for using non

pharmaceutical

- grade compounds in regulated animals. Change to : Pharmaceutical

- Grade Substances in
Research Investigators are expected to us e pharmaceutical

- grade substances whenever they are available, even in acute procedures. This
includes but is not limited to: compounds, medications, drugs, vehicles, and diluents. No n

pharmaceutical

- grade substances should only be used in regulated animals after specific review and approval by the IACUC . The IACUC should develop a consistent evaluation process which
includes but not limited to the scientific justification and the availability of an acceptable veterinary or human pharmaceutical

- grade product . Cost savings alone is not sufficient



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### USDA

- APHIS

- Animal Care
Animal Welfare Act Summary Changes to Policy #3

– Veterinary Care

justification for using a non

- pharmac eutical

grade substance in regulated animals. APHIS recognizes that most test articles and novel compounds are by definition not available in

p harmaceutical grade.

Consultation with the attending v eterinarian and
consideration of alternatives are required when

proce dures that use non

- pharmaceutical grade
substances may potentially cause more than slight or momentary pain or distress.

Surger y Surgery

ADD : Professional Standards and Established
Procedures: Current professional standards preclude eating, drinkin g, or smoking in surgery

areas. L ocations used for food handling purposes do not qualify as acceptable areas for performing surgeries.

Survival Surgeries: AWA regulations require that survival surgeries be performed using aseptic techniques and that major operative procedures on nonrodents be performed only in dedicated surgical facilities. For the purposes of this policy, designated surgical facilities are those that are set up to be cleaned and maintained in an aseptic condition, and are not used for other purposes when they are not being used for surgery. They must be maintained in good repair to meet aseptic requirements. No Change

APHIS has determin ed that motel meeting rooms and auditoriums do not qualify as dedicated surgical facilities. Change to : APHIS has determined that h otel meeting rooms and auditoriums do not qualify as dedicated surgical facilities.

Nonsurvival Surgeries: Nonsurvival s urgeries do not require aseptic techniques or dedicated facilities but should be performed in a clean area, free of clutter, and using acceptable veterinary sanitation practices equivalent to those used in a standard examination/treatment room. Personnel p resent in the area should observe reasonable cleanliness practices for
both themselves and the animals

. No C hange



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### USDA

- APHIS

- Animal Care
Animal Welfare Act Summary Changes to Policy #3

– Veterinary Care

A dd : The performance of nonsurvival surgeries in hotel meeting rooms and auditoriums as practiced in instances such as teaching situations
and demonstration can only occur provided the requirements for nonsurvival surgery and minimizing pain and distress are met. Current professional standards preclude eating, drinking, or smoking in surgery areas, and locations used for food
h andling purposes do not qualify as acceptable areas for performing surgeries. The change : paragraph moved to the beginning of the surgery section.

Pre

- and Post

- Procedural Care All animal activity proposals involving surgery must provide specific details of pre

- through post

- procedural care and relief of pain and distress. The principal investigator must involve the attending veterinarian or his/her designee in planning the type of care that may be provided. The appropriate use of drugs to relieve pain and/or distress should be specified in the animal activity proposal to avoid possible delays due to investigator concerns that a treatment regimen may interfere with the study. Furt hermore, the specified drugs for relief of pain and/or distress must be readily available for use as described in the proposal. However, the attending veterinarian retains the authority to alter post

- operative care if unexpected pain and/or distress occur in an animal. The IACUC must approve a significant change to the protocol if the attending veterinarian requests to alter post

- operative care for the remaining animals. The withholding of pain and/or distress relieving care must be scientifically justified in writing and approved by the

IACUC.

While an animal is under post

- surgical care, the ownership of the animal is not to change. If the animal is
taken to an off

- site location, such as a farm, for post

operative care, that location should be identified as a site of the research facility or a site of another registered research facility in order for AC to conduct an inspection.

To comply with adequate veterinary care requirements and in accordance with currently accepted standards of practice, an animal is not to be taken to an off

- site location before it fully recovers from anesthesia unless justified in the animal activity proposal. Appropriate No C hange

Change to : In the event the animal is taken to an
off

- site location, such as a farm, for post

operative care, that location should be identified as a site of the research facility or a site of another registered research facility in order for AC to conduct an inspection.

No C hange



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### USDA

- APHIS

- Animal Care
Animal Welfare Act Summary Changes to Policy #3

– Veterinary Care

post

- operative records should be maintained in accordance with professionally accepted veterinary procedures r egardless of the location of the animal. Program of Veterinary Care
Facilities which do not have a full

- time attending veterinarian must have a written Program of Veterinary Care (PVC). This Program must consist of a properly completed APHIS Form 7002 or an equivalent format. The attending veterinarian must visit the facil ity on a regular basis, i.e., often enough to provide adequate oversight of the facility’s care and use of animals. APHIS recommends this visit occur at least annually. Records of visits by the attending veterinarian should be kept to
include dates of the visits and comments or recommendations of the attending veterinarian or other

veterinarians.

The PVC should be reviewed and updated whenever necessary (e.g., as a new species of animal or a new attending veterinarian is obtained, or the preventive
medical program changes). APHIS recommends that the PVC be initialed and dated by both the attending veterinarian and the facility representative whenever it is changed or reviewed without change. The preventive medical program described in the PVC is expected to be in accordance with professionally accepted veterinary practice (e.g., appropriate vaccinations, diagnostic testing). It should include zoonotic disease prevention

measures No C hange

Declawing and Defanging Practices in Wild or Exotic
Carnivores or Nonhuman Primates Declawing of wild and exotic carnivores and the removal or reduction of canine teeth in nonhuman primates and wild and exotic carnivores have been used in the past in an attempt to minimize dangers presented during human
interaction with these species. These procedures are not innocuous and can cause ongoing pain, discomfort, or other pathological conditions in the animals. In addition, they do not prevent predatory behaviors, safeguard the general public, or prevent biting in nonhuman pri mates
and carnivores.

The declawing of any wild or exotic carnivore does not constitute appropriate veterinary care. Any medical treatment of a paw should be limited to the affected digit(s) or area and should not require bilateral No Change

Change to: The declawing of any wild or exotic carnivore does not constitute appropriate veterinary care unless prescribed by the attending veterinarian for treatment of individual medical problems of the paws. Any



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### USDA

- APHIS

- Animal Care
Animal Welfare Act Summary Changes to Policy #3

– Veterinary Care

declawing.

The removal of the canine teeth of a nonhuman primate, or wild or exotic carnivore, unless for the immediate
medical needs of the animal does not constitute appropriate veterinary care.

Tooth reduction that exposes the pulp cavity does not constitute appropriate veterinary care as it may result in oral pathologic conditions and pain. Reduction that does not expose the pulp cavity may be acceptable in some

instance s such as a behavioral study or breeding

situation.

The American Veterinary Medical Association (AVMA) has developed a policy statement on these issues that supports APHIS’ recommendation. It also suggests alternatives to dental surgery such as behavioral modification, environmental enrichment, and changes in group composition. A full text of AVMA policies can be
found on www.avma.org

. medical treatment of a paw should be limited to the affected digit(s) or area

.

Change to : The removal of the canine teeth of a nonhuman primate, or wild or exotic carnivore, does not constitute appropriate veterinary care unless as prescribed by the attending

veterinarian for the immediate medical needs of
the animal.

No Change

No C hange

Health Records Health records are needed to convey necessary information to all people involved in an animal’s care. Every facility should have a system of health records sufficiently comprehensive to demonstrate the delivery of adequate health care. No C hange



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### USDA

- APHIS

- Animal Care
Animal Welfare Act Summary Changes to Policy #3

– Veterinary Care

For traveling exhib itors, information on any chronic or ongoing health problems and information on the most current preventive medical procedures should accompany any traveling animals, but the individual medical history records may be maintained at the home

site.
Euthanasia
The method of euthanasia should be consistent with the
current AVMA Guidelines on Euthanasia ( http://www.avma.org/issues/animal_welfare/euthanasi a.pdf ), the America n Association of Zoo Veterinarians (AAZV) Guidelines for Euthanasia of Nondomestic Animals or the European Commission Working Party documents ( http://www.lal.org.uk/ ). Change to: The method of euthanasia should be
consistent with the current AVMA Guidelines for
the Euthanasia of Animals: https://www.avma.org/KB/Policies/Pages/Eutha

nasia

- Guidelines.asp x

.

Gunshot as a routine method of euthanasia endangers surrounding animals, buildings, and personnel, and it is likely to cause distress to other animals.

It should only be used in situations where other forms of acceptable euthanasia cannot be used (such as emergency or field conditions where the animal cannot be appropriately restrained) or in cases where gunshot will reduce danger to other animals or huma ns. Only personnel skilled in the use of firearms, using appropriate firearms, and familiar with the "kill point" of an animal should perform the euthanasia. If the firearm is not aimed so that the projectile enters the brain and causes rapid unconsciousne ss and subsequent death without evidence of pain or distress, this method does not meet the definition of euthanasia. (All State and local laws relevant to gunshot must also be met.) No C hange

Change to: This method is conditionally acceptable under a specific set of circumstances
in order to ensure the welfare of the animal undergoing euthanasia. Such circumstances
include instances where other forms of acceptable euthanasia cannot be used (e.g. emergency or field conditions where the animal
cannot b e appropriately restrained) or includes situations where gunshot reduces the danger to other animals or humans. Only personnel skilled in the use of firearms, using appropriate firearms, and familiar with the "kill point" of the animal should perform the e uthanasia. If the firearm is not aimed so that the projectile enters the brain and causes rapid unconsciousness and subsequent death without evidence of pain or distress, the definition of euthanasia is not met. However, it may not be appropriate to target the head when samples of brain tissue are needed, hence gunshot through the heart may be necessary in such situations. Note: All State and local laws relevant to gunshot must also be met.

Also note that in accordance with the "Expired Medical Materials" section of this policy, the use of expired euthanasia drugs is considered inadequate veterinary

care. No Change



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