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USDA Animal Care Policies 1-10Last updated on 06/16/01 Policy #1 --- License Denial --- April 14, 1997 History: This replaces the September 3, 1992 memo entitled "Denial of AWA License Applications." Justification: Under the Animal Welfare Act (AWA) regulations and standards, the Animal & Plant Health Inspection Service (APHIS), Animal Care (AC) can deny an AWA license application under certain restricted circumstances. This policy serves to clarify when a license application can be denied, and when and what it means for a license to be invalid. Policy: The Investigative & Enforcement Services (IES) staff has met with the Office of General Counsel (OGC) and identified the following situations where the denial of a license is appropriate:
The Animal Care Regional Director (ACRD) will issue a letter (attached) to the applicant informing him/her of APHIS' denial of his/her license application. The denial letter will notify the applicant of his/her right to a formal administrative hearing to show why the application should not be denied as required in Section 2.11(b). The letter will also inform the applicant of the procedures required to request a hearing. The license denial will remain in effect until the final legal decision. Once a hearing is requested, IES will be responsible for compiling a case of existing evidence and submitting it through the ACRD to the IES staff within a short period of time. The IES staff will coordinate with OGC to arrange a hearing date.
IES will prepare a case file documenting the evidence from the State or local case including a copy of the court's decision and sentence levied. The ACRD will inform the applicant of APHIS' denial of license application with a letter. The letter will contain information on the applicant's right to a hearing and procedures to initiate the process. Once a hearing is requested, the ACRD will immediately submit the case to IES staff. The IES staff will coordinate with OGC to arrange a hearing date.
IES will conduct an investigation and collect evidence to substantiate or refute the allegations. The evidence should include information collected by State or local investigators in addition to corroborating evidence from interviews and/or AC inspections. The ACRD will submit the case to the IES staff for review and forwarding to OGC. If OGC concurs with the denial, IES staff will notify the ACRD. The ACRD will issue a letter informing the applicant of the denial of license application. The letter will contain information on the applicant's right to a hearing and procedures to initiate the process. If a hearing is requested, the ACRD will submit the case to IES staff. The IES staff will coordinate with OGC to arrange a hearing date. What is a "valid" license? A license shall be considered valid and effective unless:
Licenses are issued for specific premises and are not valid at a different location. Dear_____: This letter is to inform you that your application for a license under the Animal Welfare Act (7 U.S.C. 2131 et seq.) is denied pursuant to Section 2.11 of the regulations (9 C.F.R. 2.1 et seq.) for the following reason(s): _______ Failure to comply with the requirements of Section 2.1 of the regulations (9 C.F.R. 2.11(a)(1)). _______ Failure to comply with the requirements of Section 2.2 of the regulations (9 C.F.R. 2.11(a)(1)). _______ Failure to comply with the requirements of Section 2.3 of the regulations (9 C.F.R. 2.11(a)(1)). _______ Failure to comply with the requirements of Section 2.4 of the regulations (9 C.F. R. 2.11(a)(1)). _______ Failure to comply with the requirements of Section 2.6 of the regulations (9 C.F.R. 2.11(a)(1)). _______ License has been revoked or is currently suspended as set forth in Section 2.10 of the regulations (9 C.F.R. 2.11(a)(3)). _______ Has been fined, sentenced to jail, or pled nolo contendere (no contest) and paid a penalty under State or local cruelty to animal laws within 1 year of application (9 C.F.R. 2.11(a)(4)). _______ Has made false or fraudulent statements or has provided false or fraudulent records to the Department (9 C.F.R. 2.11(a)(5)). You may request a hearing in accordance with the applicable Rules of Practice for the purpose of showing why your application for a license should not be denied. You must notify this office, in writing by certified mail, within 20 days from receipt of this letter if you desire a hearing, and a hearing will be held in due course. Failure to request a hearing within 20 days from receipt of this letter will be deemed a waiver of such hearing. If you have any questions with reference to this matter, please do not hesitate to contact this office by mail or by phone at _________________. Sincerely, Policy #2 --- Submission of Traveling Exhibitor Itinerary --- April 14, 1997 History: This is a new policy statement, to remain in effect until enacted into regulatory changes. Justification: The Animal Plant & Health Inspection Service (APHIS), Animal Care (AC) has been provided the authority to require whatever records or reports are needed to effectively enforce the Animal Welfare Act (AWA). In order for licensed traveling facilities to comply with the requirement of readily available access to the premises by the APHIS inspector, APHIS must be kept apprised of the location of the facility. Exhibitors who are in continuous travel status shall update their itinerary as often as necessary to ensure AC knows their whereabouts at all times. Circuses, petting zoos, and acts with an established route shall notify AC in advance of departing their home facility and update travel information as needed. Exhibitors who take animals from their facilities from time to time shall notify AC when any animal is gone more than four (4) consecutive days. Upon request, a licensee shall provide an itinerary of absences of less than four (4) days. Providing notification ensures the opportunity for access for an unannounced inspection, eliminates unnecessary AC visits when a licensee has been inspected recently, and minimizes resources needed to locate the exhibitor. The itinerary should provide the following:
Similar information must be provided for all periods of "lay-over" while traveling. The licensee may provide this information to AC by any of the following methods:
Notice must be made in advance of travel and updated as needed. Policy #3 --- Veterinary Care--- April 14, 1997 -- Last revision on January 14, 2000 Pharmaceutical-Grade Compounds in Research Surgery Pre- and Post-Procedural Care Program of Veterinary Care Health Records Euthanasia History: Provides requested guidance. Replaces memoranda dated May 31, 1990, November 29, 1991, April 6, 1992, and September 25, 1992. The previous version of this policy released on April 14, 1997, has been modified to include "Health Records." Justification: The Animal Welfare Act (AWA) requires that all regulated animals be provided adequate veterinary care. The use of expired medical materials such as drugs, fluids, or sutures on regulated animals is not considered to be acceptable veterinary practice and does not constitute adequate veterinary care as required by the regulations promulgated under the Animal Welfare Act. All expired medical materials found in a licensed or registered facility are to be brought to the attention of the responsible official. The facility must either dispose of all such materials or segregate them in an appropriately labeled, physically separate location from non-expired medical materials. The Animal & Plant Health Inspection Service (APHIS) has no jurisdiction over facilities using expired medical materials for non-regulated animals or non-regulated activities. For acute terminal procedures, APHIS does not oppose the use of expired medical materials if their use does not adversely affect the animal's well-being or compromise the validity of the scientific study. Proper anesthesia, analgesia, and euthanasia are required for all such procedures. Drugs administered to relieve pain or distress and emergency drugs must not be used beyond their expiration date. 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. These responsibilities cannot be met unless the veterinarian and the IACUC maintain control over the use of expired medical materials. Pharmaceutical-Grade Compounds in Research Investigators are expected to use pharmaceutical-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 necessity or non-availability of an acceptable veterinary or human pharmaceutical-grade product. Cost savings alone are not an adequate justification for using non-pharmaceutical-grade compounds in regulated animals. 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. Nonsurvival surgeries require neither aseptic techniques nor dedicated facilities if the subjects are not anesthetized long enough to show evidence of infection. Research facilities doing surgical demonstrations while traveling must use aseptic techniques and dedicated surgical facilities. Motel meeting rooms and auditoriums do not qualify as dedicated surgical facilities. Nonsurvival surgeries not performed aseptically or in a dedicated facility must at least be performed in a clean area, free of clutter, and using acceptable veterinary sanitation practices analogous to those used in a standard examination/treatment room. Personnel present in the area must observe reasonable cleanliness practices for both themselves and the animals. Eating, drinking, or smoking are not acceptable in surgery areas, and locations used for food handling purposes do not qualify as acceptable areas for performing surgeries. All animal activity proposals involving surgery must provide specific details of pre- through post-procedural care and relief of pain and distress. The specific details must be approved by the attending veterinarian or his/her designee. However, the attending veterinarian retains the authority to change post-operative care as necessary to ensure the comfort of the animal. The withholding of pain and/or distress relieving care must be scientifically justified in writing and approved by the IACUC. The appropriate use of drugs to relieve pain and/or distress must be specified in the animal activity proposal to avoid possible delays due to investigator concerns that a treatment regimen may interfere with the study. Furthermore, the specified drugs for relief of pain and/or distress must be readily available for use as described in the proposal. 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. 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 post-operative records must be maintained in accordance with professionally accepted veterinary procedures regardless of the location of the animal. 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 providing all of the information required by the APHIS form. The attending veterinarian must visit the facility on a regular basis, i.e., often enough to provide adequate oversight of the facility's care and use of animals but no less than annually. The PVC must be reviewed annually 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). It must 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 common good veterinary practices (e.g., appropriate vaccinations, diagnostic testing). It should include zoonotic disease prevention measures and, if necessary, special dietary prescriptions. Health records are meant to convey necessary information to all people involved in an animal's care. Every facility is expected to have a system of health records sufficiently comprehensive to demonstrate the delivery of adequate health care. For those facilities that employ one or more full-time veterinarians, it is expected there will be an established health records system consistent with professional standards that meets and probably exceeds, the minimum requirements set forth in this policy. For facilities that do not employ a full-time veterinarian, it is suggested the health records system be explained as part of the written PVC, to ensure involvement of the attending veterinarian in developing the system. For all facilities, health records must be current, legible, and include, at a minimum, the following information:
Examples of procedures which should be adequately documented in health records include, but are not limited to, vaccinations, fecal examinations, radiographs, surgeries, and necropsies. Routine husbandry and preventive medical procedures (e.g., vaccinations and dewormings) performed on a group of animals may be recorded on herd-health-type records. However, individual treatment of an animal must be on an entry specific to that animal. As long as all required information is readily available, records may be kept in any format convenient to the licensee/registrant (e.g., on cage cards for rodents). Health records may be held by the licensee/registrant (including, but not limited to, the investigators at research facilities) or the attending veterinarian or divided between both (if appropriately cross-referenced), but it is the responsibility of the licensee/registrant to ensure that all components of the records are readily available and that the record as a whole meets the requirements listed above. An animal's health records must be held for at least 1 year after its disposition or death. (Note: Some records may need to be held longer to comply with other applicable laws or policies.) When an animal is transferred to another party or location, a copy of the animal's health record must be transferred with the animal. The transferred record should contain the animal's individual medical history, information on any chronic or ongoing health problems, and information on the most current preventive medical procedures (for example, the most recent vaccinations and dewormings). For traveling exhibitors, information on any chronic or ongoing health problems and information on the most current preventive medical procedures must accompany any traveling animals, but the individual medical history records may be maintained at the home site. The method of euthanasia must be consistent with the current Report of the AVMA Panel on Euthanasia. Gunshot is not an acceptable method of routine euthanasia for any animal. Gunshot as a routine method of euthanasia not only endangers surrounding animals, buildings, and personnel, but 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 humans. 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 unconsciousness 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.) Policy #4 ---Use of Leased Animals by Licensees --- April 14, 1997 History: This replaces the March 6, 1992 memo entitled "Use of Leased or Rented Animals by Licensees." Justification: When leased animals are used by another licensee, the responsible party or parties need(s) to be consistently identified in the event of alleged Animal Welfare Act (AWA) violations involving those animals. This policy serves to clarify this issue. Animals are subject to AWA jurisdiction when they are used in regulated activities. Animals that are leased are still regulated, even if they are not in the custody of their owners. Both lessee and lessor must be licensed, as indicated in 9 CFR, Section 2.6, which describes that lessee and lessor shall both pay a fee as dealer, or lessee and lessor shall both include the animals held when calculating the required fees as an exhibitor. Exhibitors and dealers must keep records which identify animals they own, hold for others, or keep in their possession or under their control. The Regional Director is authorized to grant an exemption from licensing when issuing a license would not effectuate the purposes of the Animal Welfare Act, e.g., one-time use of a non-performing animal for the purpose of making an advertisement. Policy #5 --- Licensing of Exotic Animal Auction Markets --- April 14, 1997 History: This replaces the February 1, 1991 memo entitled "Licensing of Exotic Animal Auction Markets." Justification: Until the proposed exotic animal auction regulations are cleared and published, guidelines are needed to address these growing markets. All auction markets that sell exotic or wild animals are required to be licensed. The market operator is responsible for compliance with all regulations and standards, including transportation standards, once the animals are accepted by the auction market. If the consignor is licensed, compliance will be the responsibility of both the licensee and the market. The standards for record keeping, transportation, cleaning, sanitation, and general animal health and well-being will be monitored and enforced. Incompatible animals are not to be held in the same enclosure or close to other animals that may cause them stress. All caged and/or dangerous animals must be held in a manner that ensures the safety of the animals and the public. A species-appropriate containment area is required around the loading and unloading areas to prevent the escape of animals. Policy #6 (Revised) -- Space and Exercise Requirements for Traveling Exhibitors -- October 13, 1998 9 CFR, Part 3 Sections 3.6, 3.8, 3.28, 3.53, 3.80, 3.104, 3.128 History: This replaces the June 6, 1984, memo entitled "Traveling Animal Acts-Cage Spaces for Dogs, Cats, and Nonhuman Primates." It expands and clarifies enclosure space and exercise requirements for traveling exhibitors. The previous version of this policy released on March 5, 1998, has been modified to provide better clarification of the requirements regarding space for vertical posturing. Justification: Some traveling exhibitors maintain animals long term in transport cages during "travel status." This policy clarifies when the licensee is required to meet full primary enclosure space requirements and/or provide sufficient exercise space and time for animals in traveling exhibits. Animals exhibited in traveling shows may be kept in enclosures that meet the space requirements for transport enclosures as specified in Sections 3.14, 3.36, 3.61, 3.87, 3.113, and 3.137 ONLY during actual transport, i.e., movement in a conveyance between temporary locations. At all other times, they must be provided with space as described below.
Subpart F animals (for example, elephants, hoofstock, and exotic cats) are required to have "sufficient space to allow each animal to make normal postural and social adjustments with adequate freedom of movement." Enclosures that allow only postural adjustments are inadequate to meet this requirement. "Adequate freedom of movement" includes the ability to exercise. Since it is sometimes difficult for a traveling exhibitor to provide a primary enclosure large enough to allow an animal sufficient exercise, an enclosure that allows only "normal postural and social adjustments" will be considered acceptable if the animal contained therein is released regularly from the primary enclosure (or tether) into a secure space, such as a ring or corral, that provides the opportunity for species-appropriate exercise. This release must occur at least once per day for an appropriate length of time unless otherwise justified. These periods will be in addition to regular performance and practice time. For some species, an area enclosed by an electrical fence is acceptable for this purpose if monitored at all times. Trained elephants and domestic hoofstock may be walked by a qualified handler for this purpose. These provisions apply only to the need for additional space for exercise. Other than to satisfy the vertical posturing needs of animals that occasionally exhibit such movement, the requirement for "sufficient space to allow each animal to make normal postural and social adjustments" cannot be met by periodic release into a larger enclosure. When a traveling exhibitor is not actually in transit (i.e., when he/she is set up for a show or in a holding location), animals must be kept in enclosures which allow them to express postural adjustments typical of their species. Policy #7 --- Group Classifications for Nonhuman Primates --- April 14, 1997 History: Replaces July 31, 1991 policy entitled "Clarification of Owl Monkey as a Group 2 Species," and June 30, 1992, letter regarding classification of tree shrews. Justification: Clarification is needed to specify group classifications for various species of nonhuman primates in order to determine proper space requirements. In reference to space requirements under Section 3.80, the following will apply:
These species have been designated as brachiating since this term applies to any primate whose form of locomotion involves using its arms, legs, and/or tail while its body is suspended. The intent of the space regulations is to provide sufficient space for all species-typical postural and locomotive behaviors. Since each of these species engages in brachiating-type movement, they require the larger space provided for Group 6 primates. Tree Shrews-The scientific community has removed tree shrews from the Suborder Prosimii. Therefore, they are no longer classified as primates and are not required to meet space or environmental enrichment requirements for primates. Policy #8 --- Guidelines for the Confiscation and Destruction of Animals --- April 14, 1997 History: This replaces August 17, 1992, REAC Memorandum No. 990, entitled, "Guidelines for Confiscation and Destruction of Animals." Justification: Under the Animal Welfare Act (AWA), the Animal Plant & Health Inspection Service (APHIS), Animal Care (AC) is authorized to confiscate and destroy regulated animals if they are suffering. This guideline specifies the protocol for such action. If animals are found to be suffering and relief has not been provided by the licensee or registrant, and with all due consideration to the provisions of Section 2.38(e), Confiscation and Destruction of Animals at research facilities, this policy provides instructions to:
I. Determination of Suffering A. Recognition of suffering - Veterinary Medical Officers (VMO) and Animal Care Inspectors (ACI) are qualified to recognize a suffering animal. If the determination is made that the animal is suffering, such determination must be confirmed by an Animal Care (AC) veterinarian. If possible, suffering should be confirmed by two AC veterinarians. The determination must be documented with a complete inspection to include photographs and/or other physical evidence as may be required. A private veterinarian may also be requested to examine the animal. If it is determined that the animal is not suffering, document any noncompliant items and set a deadline for correction. In all cases, the documentation shall included the completion of the appropriate APHIS inspection forms, citing the noncompliance(s) in detail. B. Disagreement that an animal is suffering- If the owner/manager/responsible person, hereafter referred to as "responsible person," disagrees with the written notification by the AC representative that the animal is suffering, he/she may call in a qualified veterinarian for a second opinion. This must be done as soon as possible within the maximum time frame of 24 hours, so as not to jeopardize the health and well-being of the animal. This is subject to approval by the AC representative. The second opinion will be considered ONLY if the veterinarian provides a signed written statement to the responsible person and to the AC representative indicating the following:
If AC disagrees with the veterinarian's findings, the Animal Care Regional Director (ACRD) may obtain the assistance of a non-APHIS veterinarian experienced with the species of animal involved. The final decision in determining animal suffering shall be the decision of the ACRD based upon the findings of the AC veterinarian and/or expert involved. The ACRD shall maintain contact with the responsible person until the matter is resolved. C. Agreement that an animal is suffering- The responsible person should immediately provide the necessary relief, veterinary care, or euthanasia, within the time frame specified which should not exceed 24 hours. If the animal is an endangered species or a marine mammal, the AC representative should also comply with the requirements of the cooperative agencies (see Section III - "Procedures for Confiscation and Destruction of Suffering Animals" of this policy). The animal may be disposed of on the licensee's premises or the registrant's facility, provided such disposal complies with all local, State and Federal laws. Follow-up is essential to verify this part has been accomplished to AC satisfaction. The ACRD shall maintain contact with the responsible person until the matter is satisfactorily resolved. II. Notification A. Notification of Owner - If it is determined that the animal is suffering and in need of veterinary care, the AC representative (with the approval of the ACRD) should immediately notify the responsible person, both verbally and in writing, and request correction of the problem. Copies should be forwarded immediately to the AC Regional office. This notification must include the following:
Follow-up notification will be accomplished by the ACRD. B. Notification of the Deputy Administrator - Notification will be forwarded through the Assistant Deputy Administrator for Animal Care (ADAAC) to the Deputy Administrator (DA), AC, as soon as possible. A copy of the notification to the owner should be faxed to AC Headquarters. C. Notification of Investigative & Enforcement Services (IES) - Contact the IES Regional Director (IESRD) for assistance prior to the official notification of the responsible person, if possible. The IES investigator should assist in documentation of violations and suffering during examination by AC. III. Procedures for Confiscation and Destruction of Suffering Animals A. Responsible person
B. Obtain authority to confiscate - If any animal (as defined in 9 CFR, Subchapter A, Part 1, Section 1.1) is subject to confiscation or euthanasia due to suffering and lack of care, the AC representative, after informing the responsible person in writing, shall immediately inform the ACRD. The ACRD shall take the following actions:
The ADAAC shall, through the DA, AC, seek approval from the APHIS Administrator concerning confiscation of the animal(s) under the authority of Section 16(a) of the Act, and as provided in Sections 2.129 and/or 2.38 of the regulations. C. Endangered species or marine mammals - If the suffering animal subject to confiscation is an endangered species or a marine mammal, the AC representative will advise the ACRD. The ACRD will notify the ADAAC. The ADAAC shall inform the DA, AC, who will inform the Department of the Interior, the Department of Commerce, and/or other appropriate cooperating services as required in Sections 2.38 and 2.129(c), and by any functioning Interagency Agreement. D. Arranging for facility to hold confiscated animal - The confiscated animal may be held by AC on the premises, provided that the premises comply with AWA standards and regulations. AC shall maintain constant supervision of the confiscated animal on the premises. If the confiscated animal cannot be held on the premises, the ACRD should arrange for transportation and transfer of the animal to licensees or registrants who are in compliance with the AWA regulations and standards, or humane agencies, animal shelters, or pounds. The ACRD should ensure proper care, holding, treatment or euthanasia of the animal at the facility receiving the confiscated animal. E. Seizure of animal
IV. Disposition of Confiscated Animal The ACRD shall arrange, at APHIS' expense, subject to recovery from the responsible person, the following provisions:
The ACRD may seek the cooperation of local humane organizations, zoos, and shelters for the use of their transportation, personnel, and other facilities at no expense to the public or to APHIS when possible. all liabilities. If for any reason, the confiscated animal cannot be moved to other premises, it should be provided the care required to ensure relief and treatment, or euthanized and disposed of, as necessary. All local, State and Federal regulations, including environmental protection regulations, should be followed when disposing of a confiscated animal. An animal that is not to be returned to the owner, and that does not require euthanasia, will be placed in another facility at no cost to APHIS whenever possible. If it cannot be placed after a reasonable time, it will be euthanized. V. Guidelines for Billing and Reimbursement for Confiscation of Animal
VI. Documenting an Alleged Violation After relief to the suffering animal has been provided by the facility or through confiscation, IES will document all apparent violations of the AWA which led to the suffering of the animal. This report shall be submitted by the ACRD as an alleged violation to the IES staff within 15 calendar days after the completion of the confiscation procedures. VII. Summary suspension of license and injunctive relief An immediate summary suspension of the license, as provided in the AWA, Section 19, may be recommended by the ACRD at this time. The request should be made immediately by the ACRD by telephone to the IES Staff Director and supported by a preliminary report prepared by IES, documenting evidence that the Act, regulations, and/or standards have been violated. The evidence shall be submitted by the ACRD as an alleged violation to the IES staff. TO:______________________________________________________________ Notice is hereby given that the following animals (list attached) are hereby
confiscated by the U.S. Department of Agriculture, Animal and Plant Health
Inspection Service, pursuant to the authority of Section 16 of the Animal
Welfare Act (7 U.S.C. 2146) and Title 9, Code of Federal Regulations, Section
2.129 (9 C.F.R. 2.129), for failure to provide necessary care for the animals. Animal and Plant Health Inspection Service
TO: ____________________________________________________________ Notice is hereby given that the animals identified on the attached inspection report dated_______________________________, are subject to confiscation by the U.S. Department of Agriculture, Animal and Plant Health Inspection Service, and may be confiscated unless the instructions given in the report are followed. Such action is authorized by Section 16 of the Animal Welfare Act (7 U.S.C. 2146) and Title 9, Code of Federal Regulations, Section 2.129 (9 C.F.R. 2.129). Should you need further information, you may
contact_______________________________
at__________________________________(phone number). Animal Care
Date: Subject: Billing and Collection for Confiscated Animals Please make payment to John Doe, File No. 12345, City, State, in the amount of $999.99 (bill enclosed), and charge accounting code 12345-67890. John Doe provided examination, evaluation, euthanasia, and necropsy services on June 1, 2, 3, and 4, 1992, for the animal(s) confiscated from Jack Smith, 1234 Main Street, City, State. Refer to 9 CFR, Animal Welfare, Section 2.129 (a), (b), and (c). Also, please bill for collection Jack Smith at the above address using the following statement of charges: All costs for providing care, treatment, euthanasia, or disposition of confiscated animals (as provided in Section 2.129 (a), (b), and (c) of the 9 CFR) shall be reimbursed by the person responsible for the animal(s). Enclosed is a bill for professional services provided by John Doe on June 1, 2, 3, and 4, 1992, in the amount of $999.99. When funds are received, please deposit them back to Accounting Code
12345-67890. Name Policy #9 --- Barrier Facility SPF Colony Inspection --- April 14, 1997 History: Provides requested guidance. Replaces letter dated July 5, 1991. Justification: The Animal & Plant Health Inspection Service (APHIS) must have access to inspect all covered animals at a regulated facility to ensure compliance with the Animal Welfare Act (AWA). Animals housed in barrier facilities are required to be maintained in accordance with the AWA's regulations and standards. In some cases, APHIS inspections of bonafide barrier facilities may be performed by analysis of environmental records, visual inspection through an adequate viewing window, and random selection of animals to be visually inspected. Various non-entry methods, such as video viewing from outside the barrier room, may substitute for an inadequate viewing window. If the APHIS inspector determines it is necessary to enter a barrier room to adequately complete an inspection or to resolve a suspected problem, the inspector may, by following entry procedures normally used by facility personnel, enter and complete the inspection. The inspector cannot be expected to comply with procedures not used by facility employees. The facility must supply a copy of their barrier entry procedures upon request. The facility will need to provide the inspector with protective clothing and items needed to complete the inspection (pens, paper, tape measure, flashlight, etc.). Prior to an inspection of a barrier facility, the facility may ask the inspector (as part of the standard entry procedure) to verify that he/she has not been in contact with, or exposed to, certain animals for a specified time period. Such verification is acceptable. Generally, barrier facilities require a period of no animal or specific species contact for 72 hours. The APHIS inspector will not sign any statement in which he or she accepts responsibility for the health of the animals in that barrier facility. Policy #10 --- Licensing and Registration --- April 14, 1997 History: Replaces memos dated August 28, 1990, entitled, "Determination of Need for Licensing or Registration for Antibody Production/Serum Collection" and April 17, 1992, entitled, "License Fees for the Production and Sale of Blood Products." Justification: Clarification of the licensing and/or registration of producers of antibodies, sera or other animal parts. Production of PMU is not covered by the Animal Welfare Act. A facility that produces antibodies or antisera is "testing" animals for their immune response and selects animals for production based on the results of this testing. Therefore, the facility must be registered as a research facility. A facility which harvests or produces only normal blood or sera for regulated purposes is not testing. The facility is selling parts of the animal which is maintained for this purpose. Therefore, the facility meets the definition of a dealer and must be licensed as such. A research facility selling antibodies, antisera, or other body parts for research, teaching, testing, or experimentation, would require a dealer's license in addition to its registration. This is not intended to apply to legitimate collaboration between researchers and their exchange and/or transfer of body parts, antibodies, and antisera. The class B dealer's license fee will be based on the total amount of blood product sales in a year. The cost of the animals will not be deducted from this figure, unless new animals are obtained for every batch of blood products. The table in 9 CFR, Part 2, Section 2.6(c) determines the correct fee. A license would not be required if the research facility only produces antibodies/antisera on a contract basis for particular investigators, not for resale. Horses used for the production of PMU are not covered by the AWA. This activity is not defined as research, teaching, or testing. People who deal in horses or horse parts are not required to be licensed. |
©1999, Janet Becker Rodgers, DVM, MS, DipACLAM, MRCVS All rights reserved. Comments? Send an email to janet.rodgers@vet.ox.ac.uk |