We received 269 comments (78 from members of the general public, 189 from members of the research or scientific community, and 2 from dealers) stating that the Secretary does not have the authority to establish committees with power to review or disapprove of research protocols for any reason, since this authority would deprive researchers of the scientific discretion necessary for the conduct of research. The use of appropriate pain-relieving drugs and requirement for consultation with the attending veterinarian will ensure that the drugs are administered in accordance with their accepted and established use. 2.75(a), and a clear photograph of each animal; and. Any actions taken by a Committee member or subcommittee in carrying out their duties under this part must be recorded in writing and maintained by the research facility as a Committee record. (Sect. (c) Methods and period of providing exercise opportunity. They also require that regulatory objectives be chosen to maximize net benefits to society or involve the least cost to society. (8) Primary enclosures - nonhuman primates (Section 3.80): (b) Minimum space requirements (Sect. (Sect.2.133 (e)). [FR Doc. Accordingly, revised proposal Sec. The information shall be furnished within a reasonable time as may be specified in the request for information. (1) The attending veterinarian may exempt an individual nonhuman primate from the environment enhancement plan because of its health or condition, or in consideration of its well-being. (Sect. (d) A dealer who acquires a live dog or cat from another dealer must obtain the certification required by paragraph (b) of section 2.133 and attach that to any previous certification. If you bought your dog in Illinois, the pet store is required to disclose the name and United States Department of Agriculture (USDA) license number of its breeder. 2131(b)). (3) Proper use of pain relieving drugs for any species of animals used by the facility. 89-130, published elsewhere in this issue of the Federal Register. We believe the commenters concerns are unwarranted, and that no further change is needed in the final rule. Such exemptions must be documented b y the attending veterinarian and reviewed at least every 30 days unless the basis for the exemption is a permanent condition. For these reasons, we require that the attending veterinarian have training or experience in the care and management of the different species of animals being attended. Permit Required: All species except fennec foxes. 88-014, published in the Federal Register on March 15, 1989, 54 FR 10835-10897). A. Strating,Acting Administrator, Animal and Plant Health Inspection Service. Department means the U.S. Department of Agriculture. Application and Fees. Again, only 1 commenter from the research community provided detailed information and different compliance cost estimates of implementing the proposed rules. The requirements of the Animal Welfare Act (AWA) are set forth under the Regulations and Standards in the Code of Federal Regulations (CFR). (2) For a research facility, the Committee may exempt an individual nonhuman primate from participation in some or all of the otherwise required environment enhancement plans for scientific reasons set forth in the research proposal. (d) If a procedure may cause more than momentary or slight pain or distress to the animals, it must be performed with appropriate pain-relieving drugs, unless withholding of such drugs is justified for scientific reasons, in writing, and continues only for as long as necessary; the attending veterinarian or a designee shall be consulted in planning the proposed activity; and it must not include the use of paralytics without anesthesia. (c) Notification of change of operation. The Department estimates $33 million in additional annual compliance costs for Federal and nonfederal research institutions to comply with the new regulations and requirements for the operation of the institutional animal care and use committees, increased responsibilities for attending veterinarians, and increased recordkeeping requirements. NOTE: The information in this paper contains excerpts and paraphrasing of the published regulations and standards in 9CFR, Chapter 1, Subchapter A - Animal Welfare. 2.31 (c)). 2.32 (c)(5)): (i) On appropriate methods of animal care and use (Sect. 2143(a)(3)(E)). Animal welfare, Animal housing, Dealers, Exhibitors, Research facilities, Humane animal handling. 2.38(i)(3)). Instructions for no food or water are not acceptable unless directed by the attending veterinarian. (b) "Each research facility shall establish and maintain programs of adequate veterinary care that include:" (Sect. As part of our harmonization efforts, we are replacing the term "animal care and use procedure" with the PHS Policy term, "activity." (e) Confiscation and Destruction of Animals. APHIS will supply a copy of the regulations and standards in Subchapter A - Animal Welfare, with each registration form. The latter requirement was added in the revised proposal in response to the numerous comments we received objecting that a separate, annual review would be costly and impractical. (1) Review, at least once every 6 months the research facilities program of humane care and use of animals using Title 9, Chapter 1, Subchapter A – Animal welfare, as a basis for evaluation. The appropriate section in 9 CFR should be consulted for the actual wording of that requirement. 2.31(c)(3) of the final rule. (b) A class "B" dealer shall identify all live dogs and cats under his or her control or on his or her premises as follows: (1) When live dogs or cats are held, purchased, or otherwise acquired, they shall be immediately identified: (i) By affixing to the animal's neck an official tag as set forth in Sec. 2.38(b)(2)). The https:// means all transmitted data is encrypted — in other words, any information or browsing history that you provide is transmitted securely. This final rule is issued pursuant to the Animal Welfare Act (Act), as amended, 7 U.S.C. Records that relate directly to proposed activities and proposed significant changes in ongoing activities reviewed and approved by the IACUC shall be maintained for the duration of the activity and for an additional three years after completion of the activity. It is the result of an intensive effort that began in 1985 when Congress amended the Animal Welfare Act (7 U.S.C. We disagree. (b) Any person who is licensed must file an application for a license renewal and an annual report form and pay the required fees, on or before the expiration date of the present license or the license will automatically terminate on its anniversary date. (3) The Attending Veterinarian shall be a voting member of the IACUC. In this final rule, we have included specific references to our statutory authority, as we did in the supplementary information accompanying the revised proposal, to demonstrate that ample statutory authority for these final rules exists. No tag number shall be used to identify more than one animal. If potable water is not continually available to the dogs and cats, it must be offered to the dogs and cats as often as necessary to ensure their health and well-being, but not less than twice daily for at least one hour each time, unless restricted by the attending veterinarian.... (See also sections 3.30 and 3.55). Each reporting facility shall submit an annual report to the APHIS, REAC Sector Supervisor for the State where the facility is located on or before December 1 of each calendar year. If program or facility deficiencies are noted, the reports must contain a reasonable and specific plan and schedule with dates for correcting each deficiency. Any failure to adhere to the plan and schedule that results in a significant deficiency remaining uncorrected shall be reported in writing within 15 business days by the IACUC, through the Institutional Official, to APHIS and any Federal agency funding that activity;". The definitions contained in this final rule provide specific meanings for many important terms used in the regulations and standards. (vi) The animals living conditions will be appropriate for their species in accordance with standards set forth in 9 CFR, Part 3, and will contribute to their health and comfort. Section 2.31(d)(4) provides the mechanism by which the Committee notifies the principal investigator and the research facility, in writing, of its decision to approve, withhold approval, or require modification of a proposed activity. Operative procedures conducted at field sites need not be performed in dedicated facilities, but must be performed using aseptic procedures; (x) No animal will be used in more than one major operative procedure from which it is allowed to recover, unless: (A) Justified for scientific reasons by the principal investigator, in writing; (B) Required as routine veterinary procedure or to protect the health or well-being of the animal as determined by the attending veterinarian; or. We are removing this provision from the final rule because section 13(b)(4)(A)(iii) of the Act and Sec. The class of license issued and the fee for a voluntary license shall be that of a Class "A" licensee (breeder). It also specifies that a quorum of the Committee is required for all such formal actions (7 U.S.C. Each primary enclosure shall contain no more than one weaned cat without an affixed collar and official tag, unless the cats are identified by a distinctive and legible tattoo or plastic-type collar approved by the Administrator. 87-004, published in the Federal Register on March 15, 1989, 54 FR 10897- 10954). Due to the redesignation of sections and paragraphs in the final rule, we have included the source paragraph from which the final rule is derived, where appropriate, to assist the reader. (4) The applicant has failed to pay the application fee and the annual license fee as required in Secs. By not requiring the direct involvement of the attending veterinarian in all matters relating to medical care, research facilities are accorded greater flexibility under the final rule in providing care. 3.28 (c)(3)). Found insideIn what promises to become an "Omnivore's Dilemma" for dog lovers—breed devotees and adoption advocates alike—The Dog Merchants is the first book to explain the complex and often surprisingly similar business practices that extend from ... We are revising the handling regulations to allow exhibitors to withhold food or water on a short-term basis only. Part 3 will now be amended by removing the separate provisions for handling found in the different subparts. 2.6 to the APHIS, REAC Sector Supervisor and the payment has cleared normal banking procedures. 2.2 and 2.3; and. We believe that requiring this assurance and inspecting Committee records at the research facility will reduce the paperwork and administrative burden that would be imposed upon those facilities under the revised proposal, and still fulfill the statutory directive of the Act. We solicited comments concerning the proposals for a 60-day period ending June 1, 1987. Animal shelters, pet breeders, pet dealers, pet shops, pet groomers, pet trainers, boarding kennels, aviaries, and rescue groups and humane societies that house animals all require a license issued by the Animal Protection Section of the Georgia Department of Agriculture and must be prominently displayed at each licensed place of business. The revised regulations are necessary to clarify the responsibilities of regulated persons under the Act, as amended, and to promote animal welfare. (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. 2.35(b)(3)(iii)-(v)). (2) Oblong and flat in shape, not less than 2 inches by 3/4 inch and riveted to an acceptable collar. (2) The concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress. (Sect. Handling, in addition to the standards in part 3. (4) A description of procedures designed to assure that discomfort and pain to animals will be limited to that which is unavoidable for the conduct of scientifically valuable research, including provision for the use of analgesic, anesthetic, and tranquilizing drugs where indicated and appropriate to minimize discomfort and pain to animals; and (section 2.31 (e)(4)). Though originally of foreign origin, they are not considered to be exotic. (e) Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly euthanized at the end of the procedure, or during the procedure, if appropriate. (C) Not include the use of paralytics without anesthesia; (section 2.31 (d)(1)(iv)(C)). See the Dog Breeder Resource Guide. (ix) Activities that involve surgery must include appropriate provision for pre-operative and post-operative care of the animals in accordance with established veterinary medical and nursing practices. In some cases, we believe it is sufficient to rely on ordinary usage and dictionary definitions. A summary of all such exceptions must be attached to the facility's annual report. (2) The concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress (Sect. The plan must be made available to APHIS upon request. (See initial proposal Sec. Furthermore, at many institutions the IACUC meets once each month to consider Committee business, and their scheduled meeting may not coincide with a rigid 10-day requirement. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this. (C) In other special circumstances as determined by the Administrator on an individual basis. Isolation in regard to marine mammals means the physical separation of animals to prevent contact and a separate, noncommon, water circulation and filtration system for the isolated animals. Section 2.25 requires that all other exhibitors register in accordance with the requirements of subpart B of the final rule, unless they are exempt from the licensing requirements under section 3 of the Act. (d) Restraint devices. Prior to any IACUC review, all members of the committee must be provided with a list of proposed activities to be reviewed. If the research facility does not comply, APHIS may confiscate the animals for care, treatment or disposal. (a) No dealer, exhibitor, broker, operator of an auction sale, carrier, or intermediate handler shall, for a period of 1 year, destroy or dispose of, without the consent in writing of the Administrator, any books, records, documents, or other papers required to be kept and maintained under this part. 2143(a)). Accordingly, Sec. We have continued the consultation described in the supplementary information accompanying the revised proposal (54 FR 10837), in an effort to coordinate our requirements wherever it is consistent with our statutory mandate to do so. We are revising the requirements applicable to dealers and exhibitors concerning their attending veterinarian and program of adequate veterinary care. We believe that this provision is necessary as a means of minimizing animal suffering resulting from a facility's failure to comply with the regulations. These requirements are found in Title 9 CFR, Chapter 1, Subchapter A - Animal Welfare, Parts 1, 2 and 3. Carla Steffensmeier dog breeders USDA Licenses No. (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. Subpart B is amended by removing and reserving Sec. (11) Feeding of dogs and cats (Section 3.9). Section (f) for Handling, (g) for Identification of dogs, and (h) for Health Certification. (Sect. commercial breeder, hobby or show breeder, or pet shop under sections 273.325 to 273.357. (21) Consignment to Carriers and Intermediate Handlers (Section 3.86). (iii) Proper pre-procedural and post-procedural care of animals (Sect. A copy of such certificate shall accompany the shipment to destination. Sec. should be consulted for the actual wording of that requirement. (section 3.8). If the IACUC decides to withhold approval of an activity, it shall include in its written notification a statement of the reasons for its decision and give the principal investigator an opportunity to respond in person or in writing. 2.37(a)). We initially proposed in March 1987, that the Committee must establish a reporting procedure whereby laboratory or research facility personnel or employees could report violations of the Act or regulations, including problems, deviations, or deficiencies in animal care or use. Individually housed nonhuman primates must be able to see and hear nonhuman primates of their own or compatible species unless the attending veterinarian determines that it would endanger their health, safety, or well-being. Sect. (See docket no. A mechanism of direct and frequent communication is also required so that timely and accurate information on problems of animal health, behavior, and well-being is conveyed to the attending veterinarian. FOR FURTHER INFORMATION CONTACT: Dr. Dale F. Schwindaman, REAC, APHIS, USDA, Room 206, 6505 Belcrest Road, Hyattsville, MD 20782, (301) 436-6491. This site is also protected by an SSL (Secure Sockets Layer) certificate that’s been signed by the U.S. government. (b) Any person whose license has been revoked shall not be licensed in his or her own name or in any other manner; nor will any partnership, firm, corporation, or other legal entity in which any such person has a substantial interest, financial or otherwise, be licensed. The Department considers the changes in all three parts of the Animal Welfare regulations will be a "major rule" based on anticipated cost increases in excess of $100 million for animal uses, care, and treatment. The comment period was twice extended and ended on August 27, 1987. Summary: Often referred to as the "Preamble" to the Animal Welfare Act amendments of 1985, the explanations of the regulations are used to identify the intent of the regulations published in Title 9, Code of Federal Regulations. In developing final rules, the Department has considered and will continue to consider regulations that will impose the least cost on regulated establishments within statutory goals. The annual license renewal fee for a Class "A" dealer shall be based on 50 percent of the total gross amount, expressed in dollars, derived from the sale of animals to research facilities, dealers, exhibitors, retail pet stores, and persons for use as pets, directly or through an auction sale, by the dealer or applicant during his or her preceding business year (calendar or fiscal) in the case of a person who operated during such a year. 2.30(d). Our response to the comments we received in response to the March 15, 1989 revised proposal follows. 2.8 Notification of change of name, address, control, or ownership of business. Section 2.125 Information as to business. This site will provide information and records that shed light on the USDA Animal and Plant Health Inspection Service’s (APHIS) administration of the Animal Welfare Act (AWA).
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