Current through November 30, 2024
Section 2.38 - Miscellaneous(a)Information as to business: furnishing of same by research facilities. Each research facility shall furnish to any APHIS official any information concerning the business of the research facility which the APHIS official may request in connection with the enforcement of the provisions of the Act, the regulations, and the standards in this subchapter. The information shall be furnished within a reasonable time and as may be specified in the request for information.(b)Access and inspection of records and property.(1) Each research facility shall, during business hours, allow APHIS officials:(i) To enter its place of business;(ii) To examine records required to be kept by the Act and the regulations in this part;(iii) To make copies of the records;(iv) To inspect the facilities, property, and animals, as the APHIS officials consider necessary to enforce the provisions of the Act, the regulations, and the standards in this subchapter; and(v) To document, by the taking of photographs and other means, conditions and areas of noncompliance.(2) The use of a room, table or other facilities necessary for the proper examination of the records and for inspection of the property or animals shall be extended to APHIS officials by the research facility.(c)Publication of lists of research facilities subject to the provisions of this part. APHIS will publish on its website lists of research facilities registered in accordance with the provisions of this subpart. The lists may also be obtained upon request from the Deputy Administrator.(d)Inspection for missing animals. Each research facility shall allow, upon request and during business hours, police or officers of other law enforcement agencies with general law enforcement authority (not those agencies whose duties are limited to enforcement of local animal regulations) to enter its place of business to inspect animals and records for the purpose of seeking animals that are missing, under the following conditions:(1) The police or other law officer shall furnish to the research facility a written description of the missing animal and the name and address of its owner before making a search;(2) The police or other law officer shall abide by all security measures required by the research facility to prevent the spread of disease, including the use of sterile clothing, footwear, and masks where required, or to prevent the escape of an animal.(e)Confiscation and destruction of animals.(1) If an animal being held by a research facility is not being used to carry out research, testing, or experimentation, and is found by an APHIS official to be suffering as a result of the failure of the research facility to comply with any provision of the regulations or the standards set forth in this subchapter, the APHIS official shall make a reasonable effort to notify the research facility of the condition of the animal(s) and request that the condition be corrected and that adequate care be given to alleviate the animal's suffering or distress, or that the animal(s) be destroyed by euthanasia. In the event that the research facility refuses to comply with this request, the APHIS official may confiscate the animal(s) for care, treatment, or disposal as indicated in paragraph (e)(2) of this section, if, in the opinion of the Administrator, the circumstances indicate the animal's health is in danger.(2) In the event that the APHIS official is unable to locate or notify the research facility as required in this section, the APHIS official shall contact a local police or other law officer to accompany him or her to the premises and shall provide for adequate care when necessary to alleviate the animal's suffering. If, in the opinion of the Administrator, the condition of the animal(s) cannot be corrected by this temporary care, the APHIS official shall confiscate the animal(s).(3) Confiscated animals may be placed, by sale or donation, with other registrants or licensees that comply with the standards and regulations and can provide proper care, or they may be euthanized. The research facility from which the animals were confiscated shall bear all costs incurred in performing the placement or euthanasia activities authorized by this section.(f)Handling.(1) Handling of all animals shall be done as expeditiously and carefully as possible in a manner that does not cause trauma, overheating, excessive cooling, behavioral stress, physical harm, or unnecessary discomfort.(2)(i) Physical abuse shall not be used to train, work, or otherwise handle animals.(ii) Deprivation of food or water shall not be used to train, work, or otherwise handle animals; Provided, however: That the short-term withholding of food or water from animals, when specified in an IACUC-approved activity that includes a description of monitoring procedures, is allowed by these regulations.(g)Identification of dogs and cats.(1) All live dogs or cats, including those from any exempt source, delivered for transportation, transported, purchased or otherwise acquired, sold, or disposed of by a research facility, shall be identified at the time of such delivery for transportation, purchase, sale, disposal, or acquisition in one of the following ways:(i) By the official tag or tattoo which was affixed to the animal at the time it was acquired by the research facility, as required by this section; or(ii) By a tag, tattoo, or collar, applied to the live dog or cat by the research facility and which individually identifies the dog or cat by number.(2) All official tag or tattoo numbers shall be correctly listed in the records of purchase, acquisition, disposal, or sale which shall be maintained in accordance with § 2.35 .(3) Unweaned puppies or kittens need not be individually identified while they are maintained as a litter with their dam in the same primary enclosure, provided the dam has been individually identified.(4) The official tag shall be made of a durable alloy such as brass, bronze, or steel, or of a durable plastic. Aluminum of a sufficient thickness to assure the tag is durable and legible may also be used. The tag may be circular in shape and not less than 11/4 inches in diameter, or oblong and flat in shape and not less than 2 inches by 3/4 inch, and riveted to an acceptable collar.(5) Each tag shall have the following information embossed or stamped on so that it is easily readable:(ii) Numbers identifying the State and dealer, exhibitor, or research facility (e.g., 39-AB); and(iii) Numbers identifying the animal (e.g., 82488).(6) Official tags shall be serially numbered and shall be applied to dogs or cats in the manner set forth in this section in as close to consecutive numerical order as possible. No tag number shall be used to identify more than one animal or shall be reused within a 5-year period.(7) Research facilities may obtain, at their own expense, official tags from commercial tag manufacturers. At the time the research facility is registered, the Department will assign identification letters and numbers to be used on the official tags.(8) Each research facility shall be held accountable for all official tags acquired. In the event an official tag is lost from a dog or cat while in the possession of a research facility, the facility shall make a diligent effort to locate and reapply the tag to the proper animal. If the lost tag is not located, the research facility shall affix another official tag to the animal in the manner prescribed in this section and record the tag number on the official records.(9) When a dog or cat wearing or identified by an official tag arrives at a research facility, the facility may continue to use that tag to identify the dog or cat or the tag may be replaced as indicated in paragraph (g)(1) of this section. All tags removed by a research facility shall be retained and disposed of as indicated in this section.(10) Where a dog or cat to which is affixed or which is identified by an official tag is euthanized, or dies from other causes, the research facility shall remove and retain the tag for the required period, as set forth in paragraph (g)(11) of this section.(11) All official tags removed and retained by a research facility shall be held until called for by an APHIS official or for a period of 1 year.(12) When official tags are removed from animals for disposal, the tags must be disposed of so as to preclude their reuse for animal identification. No animal identification number shall be used within any 5-year period following its previous use.(h)Health certification.(1) No research facility, including a Federal research facility, shall deliver to any intermediate handler or carrier for transportation, in commerce, or shall transport in commerce any dog, cat, or nonhuman primate unless the dog, cat, or nonhuman primate is accompanied by a health certificate executed and issued by a licensed veterinarian. The health certificate shall state that:(i) The licensed veterinarian inspected the dog, cat, or nonhuman primate on a specified date which shall not be more than 10 days prior to the delivery of the dog, cat, or nonhuman primate for transportation; and(ii) When so inspected, the dog, cat, or nonhuman primate appeared to the licensed veterinarian to be free of any infectious disease or physical abnormality which would endanger the animal(s) or other animals or endanger public health.(2) The Secretary may provide exceptions to the health certification requirement on an individual basis for animals shipped to a research facility for purposes of research, testing, or experimentation when the research facility requires animals not eligible for certification. Requests should be addressed to the Animal and Plant Health Inspection Service, Animal Care, 4700 River Road, Unit 84, Riverdale, Maryland 20737-1234.(3) The U.S. Interstate and International Certificate of Health Examination for Small Animals (APHIS Form 7001) may be used for health certification by a licensed veterinarian as required by this section.(i)Holding of animals. If any research facility obtains prior approval of the Deputy Administrator, it may arrange to have another person hold animals: Provided, That:(1) The other person agrees, in writing, to comply with the regulations in this part and the standards in part 3 of this subchapter, and to allow inspection of the premises by an APHIS official during business hours;(2) The animals remain under the total control and responsibility of the research facility; and(3) The Institutional Official agrees, in writing, that the other person or premises is a recognized animal site under its research facility registration. APHIS Form 7009 shall be used for approval.(4) The other person or premises must either be directly included in the research facility's contingency plan required under paragraph (l) of this section or must develop its own contingency plan in accordance with paragraph (l) of this section.(j)Holding period. Research facilities that obtain dogs and cats from sources other than dealers, exhibitors, and exempt persons shall hold the animals for 5 full days, not including the day of acquisition, after acquiring the animal, excluding time in transit, before they may be used by the facility. Research facilities shall comply with the identification of animals requirements set forth in § 2.38(g) during this period.(k)Compliance with standards and prohibitions.(1) Each research facility shall comply in all respects with the regulations set forth in subpart C of this part and the standards set forth in part 3 of this subchapter for the humane handling, care, treatment, housing, and transportation of animals; Provided, however, That exceptions to the standards in part 3 and the provisions of subpart C of this part may be made only when such exceptions are specified and justified in the proposal to conduct the activity and are approved by the IACUC.(2) No person shall obtain live dogs or cats by use of false pretenses, misrepresentation, or deception.(3) No person shall acquire, buy, sell, exhibit, use for research, transport, or offer for transportation, any stolen animal.(4) Each research facility shall comply with the regulations set forth in § 2.133 of subpart I of this part.(l)Contingency planning.(1) Research facilities must develop, document, and follow an appropriate plan to provide for the humane handling, treatment, transportation, housing, and care of their animals in the event of an emergency or disaster (one which could reasonably be anticipated and expected to be detrimental to the good health and well-being of the animals in their possession). Such contingency plans must:(i) Identify situations the facility might experience that would trigger the need for the measures identified in a contingency plan to be put into action including, but not limited to, emergencies such as electrical outages, faulty HVAC systems, fires, and animal escapes, as well as natural disasters the facility is most likely to experience.(ii) Outline specific tasks required to be carried out in response to the identified emergencies or disasters including, but not limited to, detailed animal evacuation instructions or shelter-in-place instructions and provisions for providing backup sources of food and water as well as sanitation, ventilation, bedding, veterinary care, etc.;(iii) Identify a chain of command and who (by name or by position title) will be responsible for fulfilling these tasks; and(iv) Address how response and recovery will be handled in terms of materials, resources, and training needed.(2) For current registrants, the contingency plan must be in place by July 5, 2022. For research facilities registered after this date, the contingency plan must be in place prior to conducting regulated activities. The plan must be reviewed by the research facility on at least an annual basis to ensure that it adequately addresses the criteria listed in paragraph (l)(1) of this section. Each registrant must maintain documentation of their annual reviews, including documenting any amendments or changes made to their plan since the previous year's review, such as changes made as a result of recently predicted, but historically unforeseen, circumstances (e.g., weather extremes). Contingency plans, as well as all annual review documentation, must be made available to APHIS and any funding Federal agency representatives upon request. The APHIS Contingency Plan form may be used to keep and maintain the information required by paragraph (l)(1) and (2) of this section.(3) The facility must provide training for its personnel regarding their roles and responsibilities as outlined in the plan. For current registrants, training of facility personnel must be completed within 60 days of the research facility putting their plan in place; for research facilities registered after July 5, 2022, training of facility personnel must be completed within 60 days of the facility putting its contingency plan in place. This deadline applies to employees hired before and up to 30 days after the facility puts its contingency plan in place. For employees hired more than 30 days after the facility puts its contingency plan in place, training must be conducted within 30 days of their start date. Any substantive changes to the plan as a result of the annual review must be communicated to employees through training which must be conducted within 30 days of making the changes.54 FR 36147, Aug. 31, 1989, as amended at 58 FR 39129, July 22, 1993; 59 FR 67612, Dec. 30, 1994; 60 FR 13895, Mar. 15, 1995; 63 FR 62926, Nov. 10, 1998; 69 FR 42101 , July 14, 2004; 77 FR 76823 , Dec. 31, 2012; 85 FR 28797 , May 13, 2020; 86 FR 68537 , Dec. 3, 2021; 88 FR 10713 , Feb. 21, 2023 85 FR 28797 , 11/9/2020; 86 FR 68537 , 1/3/2022; 88 FR 10654 , 3/23/2023 Approved by the Office of Management and Budget under control numbers 0579-0036, 0579-0479, and 0579-0486