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</html>";s:4:"text";s:29104:"(6) Review, approve, require modification or withhold approval related to the care and use of animals. Each nonhuman primate that is less than 1 year of age must be offered food once every 12 hours.....Consignors who are subject to the Animal Welfare regulations (9CFR, Parts 1, 2 and 3) must certify that each nonhuman primate was offered food and potable water within the 4 hours preceding delivery of the nonhuman primate to a carrier or intermediate handler for transportation in commerce, and must certify the date and time the food and potable water was offered, in accordance with section 3.86(c) of this subpart.". The term "Area Veterinarian in Charge" is replaced with "APHIS, REAC Sector Supervisor", however, the definition remains unchanged in the regulations. 2.2 Acknowledgment of regulations and standards. 2.31(c) and is intended to provide current information to the research facility regarding all ongoing activities so that it can remain in compliance. 2.31(d)(7)). Accordingly, Sec. Next we describe the changes we have made in the final rule, both in form and in content. 89-130, part 1--"Definition of Terms," the term "activity" is used in the final rule instead of "animal care and use procedure" or "ACUP" to conform the term with that used in the PHS Policy. Protects and improves the health, quality, and marketability of our nation's animals, animal products, and veterinary biologics by preventing, controlling, and/or eliminating animal diseases, and monitoring, and promoting animal health and productivity. (Sect. (c) In addition to the information required to be kept and maintained by every research facility concerning each live dog or cat under paragraph (a) of this section, every research facility transporting, selling, or otherwise disposing of any live dog or cat to another person, shall make and maintain records or forms which fully and correctly disclose the following information: (1) The name and address of the person to whom a live dog or cat is transported, sold, or otherwise disposed of; (2) The date of transportation, sale, euthanasia, or other disposition of the animal; and. Crosses between wild animal species, such as lions and tigers, are considered to be wild animals. (b) Training and instruction shall be made available and the qualifications of personnel reviewed frequently to comply with the regulations. Each dealer, exhibitor, operator of an auction sale, intermediate handler, and carrier shall furnish to any APHIS official any information concerning the business of the dealer, exhibitor, operator of an auction sale, intermediate handler or carrier 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. (B) Involve, in their planning, consultation with the attending veterinarian or his or her designee; (section 2.31 (d)(1)(iv)(B)). We are promulgating these regulations which govern the care, use, treatment, and handling of warm-blooded animals by research facilities and other entities, to carry out the mandate of Congress.<. 1.1). 2143(b)(1)). Weekend, holiday, and emergency care must be readily available (Sect. (d) Restraint devices. In response to numerous comments we received following publication of the March 1987 proposal, we revised the proposed regulations to allow greater flexibility to Committees in performing the requisite twice yearly inspections. (C) Not include the use of paralytics without anesthesia. As explained above under the heading "Subpart C--Research Facilities, Miscellaneous," short-term food or water deprivation has become an accepted practice in incentive-reward training systems used by exhibitors. We are continuing to require that the Committee, as an agent of the research facility, review, and, if warranted, investigate concerns involving the care and use of animals at the research facility (final rule Sec. To get this registration, the manufacturer must hold a feed license. Section 2.76 Records: Operators of auction sales and brokers. Title 9 C.F.R.,Section 2.31 Institutional Animal Care and Use Committee. NOTE /3/ See footnote 2 in Sec. 2.33(a)(3)). One member of the research or scientific community objected to considering scientifically necessary exceptions to the regulations as being areas of noncompliance or deviations which must be explained in detail by the principal investigator and included in a written report that is attached to the annual report. Sec. Unless the basis for the exemption is a permanent condition, the exemption must be reviewed at least every 30 days by the attending veterinarian. 3.8. It also includes buildings or temporary structures set up at field sites where animals are maintained for more than 12 hours. Animals housed in the same primary enclosure must be compatible and not be housed near animals that interfere with their health or cause them discomfort. The supplementary information begins with a brief history of this rule-making. (ii) That the principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals and has provided a written justification and description of the methods and sources used to determine that alternatives were not available (ex. (3) Prepare reports of the evaluations conducted above and submit them to the CEO of the research facility (Sect. Under this proposed requirement, if artificial lighting is used it must provide a wide range of wavelengths, such as infra-red and ultraviolet, so that it approximates natural sunlight. Instructions for no feed or water are not acceptable unless directed by the attending veterinarian. We are therefore providing in Sec. (3) One copy of the record containing the information required by paragraph (b)(1) of this section shall accompany each shipment of any animal(s) other than a dog or cat purchased or otherwise acquired by a dealer or exhibitor. Section 2.30 of the final rule sets forth registration requirements and procedures for research facilities. We have simplified the final rule by requiring that the Committee inspect all of the research facility's animal facilities, including animal study areas (see companion docket 89-130, published elsewhere in this issue of the Federal Register for the definition of "study area"), and that it review the facility's program for humane care and use of animals. Registrant means any research facility, carrier, intermediate handler, or exhibitor not required to be licensed under section 3 of the Act, registered pursuant to the provisions of the Act and the regulations in part 2 of this subchapter. If the Committee determines to withhold approval, it must provide the principal investigator and the research facility with a written statement explaining its decision. 2.131. (3) A nonaffiliated member. (1) The frequency, method, and duration of the opportunity for exercise shall be determined by the attending veterinarian and, at research facilities, in consultation with and approval by the Committee (Sect. (3) Records of exemptions must be maintained and made available to USDA officials and Federal funding agency. Section 2.38(f)(2)(ii) of the final rule provides that short-term withholding of food or water is allowed when specified in a proposed activity and approved by the Committee. We are also removing the provision set forth in the revised proposal which would require that the institutional official certify that each member of the Committee was given an opportunity to express concurrence or nonconcurrence with the report and to attach a minority report. (Sect. 2.27 Notification of change of operation. (iv) Regarding the intent and requirements of the Act. Section (f) for Handling, (g) for Identification of dogs, and (h) for Health Certification. We revised the proposed rule accordingly, to place responsibility on the research facilities except where specifically reserved to the Committee or attending veterinarian by the Act. The final rules have been modified to allow research facilities greater flexibility in developing internal procedures to ensure compliance with the regulations. (3) Those used in research for which the Committee-approved protocol requires restricted activity. We are also maintaining the Committee's authority to suspend an activity for noncompliance. We have modified it to require summaries of such exceptions, however, as explained in greater detail under the heading, "Subpart C--Research facilities", subheading, "Annual report.". (Final rule Sec. 2143(a)(3)(E)). The IACUC is to consist of no less than three members as follows (Sect. We received 241 comments (67 from members of the general public, 172 from members of the research or scientific community, and 2 from dealers) requesting that we clarify when farm animals are covered by the regulations. (Sect.2.102 (a)(2)). We are also exempting field studies from the Committee review and inspection requirements of 9 CFR part 2, subpart C, and have defined that term to mean any study conducted on free-living wild animals in their natural habitat which does not involve an invasive procedure and which does not harm or materially alter the behavior of the animals. (19) Feeding nonhuman primates (Section 3.82 (b)). 2.30(e)(2)). 2143(b)(1)). (Sect. (a) (1) Each dealer and exhibitor, except auction sales and brokers, shall make and maintain records or forms that correctly disclose the information required in section 2.75 (a) for each dog or cat acquired, held, transported, or disposed of. You should correct your post for Arkansas. 2.31(d)(3)). (C) Not include the use of paralytics without anesthesia. L. 89-544), (commonly known as the Laboratory Animal Welfare Act), as amended by the Act of December 24, 1970 (Pub. A total of 7,857 comments were timely received and considered. 2.30(h) and proposed Sec. (f) Primary enclosures used to transport live rabbits....shall be clearly marked on top and on one or more sides with the words "Live Animals" in letters not less than 1 inch in height and with arrows or other markings to indicate the correct upright position if the container. In accordance with the Act, we have the authority to regulate farm animals when used for biomedical research and testing purposes. (b) Any research facility, dealer, exhibitor, or Federal research facility offering a nonhuman primate to a carrier or intermediate handler for transportation in commerce must securely attach to the outside of the primary enclosure used for transporting the nonhuman primate, written instructions for a 24-hour period for the in-transit food and water requirements of the nonhuman primate(s) contained in the enclosure. For that purpose, the Department has considered and will continue to examine least cost feasible alternatives, whenever appropriate and within statutory goals, in developing the final Animal Welfare regulations. (1) Assure that professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anesthetic, analgesic, and tranquilizing drugs, prior to, during, and following actual research, teaching, testing, surgery, or experimentation were followed by the research facility; (2) Assure that each principal investigator has considered alternatives to painful procedures; (3) Assure that the facility is adhering to the standards and regulations under the Act, and that it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and approved by the IACUC. The tag may be circular in shape and not less than 1 1/4 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. The revised proposal was explicitly clear that Committees would be authorized to review the animal care and use procedure to be employed in a proposed research activity, in accordance with the requirements of the Act, and that this authority did not extend to research "protocol" approval. As previously discussed, field studies, as defined in Part 1 of the regulations (see companion docket No. 2. WHEN BOARDING ANIMALS ONLY, A STATE LICENSE IS NOT REQUIRED. We received numerous comments in response to the March 1987 proposal suggesting that we include rats and mice, and we are considering doing so. 2.35(b)(2)(i)(B)), the Committee's report must be signed by a majority of Committee members and must include any minority views of the Committee. (Section 3.2). (2) Prior to IACUC review, each member of the committee shall be provided with a list of proposed activities to be reviewed. 2.31(d)(1)). NOTE /1/ A list of the commercial manufacturers who produce these tags and are known to the Department may be obtained from the APHIS, REAC Sector Supervisor. If program or facility deficiencies are noted, the report must contain a reasonable and specific plan and schedule with dates for correcting each deficiency. All records shall be available for inspection and copying by APHIS and funding Federal agency representatives. 3.35 (c)). 2.75 and 2.77. At that time, we did not publish a proposed rule to amend part 3--"Standards" of the regulations. Sec. (Sect. (a) No dealer, exhibitor, operator of an auction sale, broker, or department, agency, or instrumentality of the United States or of any State or local government 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. (Sect. All survival surgery will be performed using aseptic procedures, including surgical gloves, masks, sterile instruments, and aseptic techniques. A subset of animal feed, pet food includes commercial food, treats, nutrient supplements and edible chews. 2.32 (c)(1)(ii)). Non major operative procedures, and all surgery on rodents, do not require a dedicated facility but must be performed using aseptic procedures. Farm animal means any domestic species of cattle, sheep, swine, goats, llamas, or horses, which are normally and have historically, been kept and raised on farms in the United States, and used or intended for use as food or fiber, or for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber. Many comments concerned the Animal Welfare regulations generally or conceptually. 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. 2.32 (c)(2)). 2.38(d)(2)). The instructions must be attached in a manner that makes them easily noticed and read. The enclosure for the nonhuman primate must be enriched by providing means of expressing noninjurious species-typical activities. 2.36(b)(1)). (v) 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, if appropriate, during the procedure. 2131, et seq.) If any portion is disapproved, notice of disapproval will be published in the Federal Register prior to that date. This provision will prove useful for those activities that are ongoing and therefore are repeatedly inspected, and will relieve some of the reporting burden that would be imposed upon the Committee under the revised proposed rule. Our initial proposal of March 1987 would have required Committee approval of a proposed "protocol" that would cause more than short-term minor pain or distress before the procedure could commence. We revised our initial proposal to clarify areas of responsibility to avoid potential conflict, and to ensure that provision is made for proper veterinary care in the planning and conduct of animal care and use procedures. 3.8(d)(2)). 2.30(e)(1)(ii) would have required that the written assurance indicate what information sources were consulted, what other procedures were considered, and what techniques will be used to minimize pain and discomfort to animals. An applicant whose check is returned by the bank will be charged a fee of $15 for each returned check. 2.30(e)(10), requiring that each research facility that engages in any practice or procedure that might reasonably be expected to be a painful procedure establish a written policy to ensure compliance with those requirements, and Sec. (a)(1) The following categories of dogs or cats must not be kept in outdoor facilities unless that practice is specifically approved by the attending veterinarian. Nonhuman primates must not be maintained in restraint devices unless required for health reasons as determined by the attending veterinarian or by a research proposal approved by the IACUC. Our ongoing consultation with the U.S. Department of Health and Human Services, as well as other Federal agencies concerned with animal welfare, also contributed significantly to determining how best to fulfill our statutory mandate. In order to accommodate this timetable, and to achieve our objective of publishing final rules on parts 1 and 2 without further delay, we declined to extend the 60-day comment period, as some commenters requested. (4) Methods whereby deficiencies in animal care and treatment are reported, including deficiencies in animal care and treatment reported by any employee of the facility. (ii) "On alternatives to the use of live animals in research;" (Sect. 2.31(c)(3)). Such exemption must be documented in the Committee-approved proposal and must be reviewed at appropriate intervals as determined by the Committee, but not less than annually (Sect. (c) Space requirements after August 15, 1995: (3) Innovative primary enclosures that do not precisely meet the space requirements but that do provide guinea pigs or hamsters with a sufficient volume of space and the opportunity to express species-typical behavior, may be used at research facilities when approved by the IACUC. 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. 2.32 (c)(5)(iv)). 2143(a)(3)(A)). In order to provide guidance to principal investigators in the preparation of proposals and thereby facilitate implementation of the rule, we have identified in final rule Sec. The term "natural habitat" necessarily excludes human intervention, and we do not believe further clarification is required. Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities. Such concerns may be addressed to the Administrator as an element of the special circumstances which might justify multiple major operative procedures. 2.31 with the following exceptions: (a) The Committee shall report deficiencies to the head of the Federal agency conducting the research rather than to APHIS; and. The requirements remain substantially as proposed in the March 1989 revised proposal, except as indicated and explained below. Operation of an animal shelter, pound or dog pound, boarding kennel, commercial kennel, contract kennel, pet shop, or exhibition facility, or activity as a commercial breeder or dealer without a valid license shall constitute a class A misdemeanor. (B) Require involvement and consultation with the attending veterinarian during planning of the activity (Sect. If lost or stray, the pound or shelter records shall provide the information required in section 2.132 (e)(2)(i)-(iv). (3.81(e)(2)). Found insideThe Customs modernization provisions has fundamentally altered the process by shifting to the importer the legal responsibility for declaring the value, classification, and rate of duty applicable to entered merchandise.Chapters cover entry ... (ii) The principal investigator has considered alternatives to painful or distressful procedures. The main intent of the amendments and the regulations is to increase the welfare of animals. (1) The members of each Committee shall be appointed by the Chief Executive Officer of the research facility; (2) The Committee shall be composed of a Chairman and at least two additional members; (i) At least one shall be a Doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated program responsibility for activities involving animals at the research facility; (ii) At least one shall not be affiliated in any way with the facility other than as a member of the Committee, and shall not be a member of the immediate family of a person who is affiliated with the facility. 2.78 Health certification and identification. Two members of the research or scientific community objected to the requirement that the attending veterinarian have formal education in veterinary medicine. Secs. In developing these regulations, the Department has given full consideration to the input and comments received from regulated establishments, the general public, and interested Federal agencies to previous alternative regulatory proposals. (e) (1) On or before the expiration date of the license (the license is good for one year), a licensee who wishes to renew the license shall submit a completed application form, the application fee of $10, and the appropriate annual fee to the AC Regional Director. (b) Training and instruction shall be made available, and the qualifications of personnel reviewed, with sufficient frequency to fulfill the research facilities responsibility. In that capacity, the Committee shall review those components of proposed activities, or proposed changes in activities, related to the care and use of animals and determine that they are in accordance with the Animal Welfare regulations unless otherwise justified (final rule Sec. (Sect.3.8 (d)(1)). 1.1 for definition of Field Study). Such exemption must be documented in the Committee-approved proposal and must be reviewed at appropriate intervals as determined by the Committee, but not less than annually. (c) Similarly, the principal investigator must provide written assurance that the proposed activities do not unnecessarily duplicate previous experiments (final rule Sec. (4) Primary enclosures - dogs and cats (Section 3.6). Enabling power: Animal Welfare Act 2006, ss. 13 (7) (10), sch. 1, paras 8, 9, 18, 19. A Quick Reference to Reports, Notifications, Certifications and Record Keeping for Dealers and Exhibitors Under the Animal Welfare Act. The Committee would allow exceptions to the Animal Welfare regulations when necessary for accomplishing the research design and explained in detail, in writing, by the principal investigator. We have conformed the language of the final rule with that of the PHS Policy as it pertains to Committee review of proposed activities involving animals, as part of our effort to harmonize our mutual requirements. A research facility shall notify the APHIS, REAC Sector Supervisor in writing at least 10 days before using, handling, or transporting animals again after being in an inactive status. The final rule is revised to clarify that the Committee may suspend an activity after a convened quorum of the Committee has reviewed the matter and a majority of the quorum favors suspension. (Sect. (7) Research facilities may obtain, at their own expense, official tags from commercial tag manufacturers./1/ At the time the research facility is registered, the Department will assign identification letters and numbers to be used on the official tags. (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. (c) A class "C" exhibitor shall identify live dogs and cats as indicated in section 2.50 (c). A breeder who meets the definition of a commercial breeder must obtain a license from the state of Missouri. This term specifically includes animals such as, but not limited to, lions, tigers, leopards, elephants, camels, antelope, anteaters, kangaroos, and water buffalo, and species of foreign domestic cattle, such as Ankole, Gayal, and Yak. If potable water is not continually available to the nonhuman primates, it must be offered to them 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 otherwise required by the attending veterinarian, or as required by the research proposal approved by the Committee at the research facility. (Sect.2.132 (e)(2)). We had required that this information be maintained by the attending veterinarian and available to us for inspection (revised proposal Sec. 2.31 (d)(1)(x)): (A) The procedure is justified for scientific reasons by the investigator, in writing (Sect. 2.31(d)(1)(iv)) and that the personnel who will be conducting procedures on the animals are appropriately qualified and trained in those procedures (final rule Sec. The records shall be in accordance with sections 2.75 and 2.76 unless the animals are lost or stray. 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. These final regulations reflect the mandate of Congress that while animal experimentation shall continue, humane methods of animal care and use be implemented by biomedical research institutions. (3) Any dealer who obtains or acquires a live random source dog or cat from a private or contract pound or shelter, including a pound or shelter he or she operates, shall hold the dog or cat for a period of at least 10 full days, not including the day of acquisition, excluding time in transit, after acquiring the animal, and otherwise in accordance with Sec. (See docket no. (1) If, in the opinion of the attending veterinarian, it is inappropriate for certain dogs to exercise because of their health condition, or well-being, those dogs may be exempted from the exercise requirement. 1531 et seq.) (Sect.2.126 (a)(5)). Available information indicates that the bulk of the regulatory impact will be due to new requirements for the exercise of dogs and a physical environment that promotes the psychological well-being of non- human primates, specific provisions required by the amendments. 2.31 (d)(5)). They should have a USDA permit number, which is required of all breeders in the United States. We have acknowledged that the overall impact on biomedical research is difficult to assess. The appropriate section in 9CFR should be consulted for the actual wording and context of that requirement. It also provides that Federal research facilities shall comply with the standards and requirements promulgated under Section 13 (a), (f), (g), and (h) of the Act (7 U.S.C. One dealer commented that the words "verbal abuse" in Sec. In our revised proposal, we sought to satisfy the Act's requirements through the use of subcommittees which would present their findings to a quorum of the Committee for approval. Twenty-nine members of the research or scientific community stated that the definition should be consistent with the recommendations of the American Veterinary Medical Association Panel on Euthanasia. Animals received through donation or as a gift must be acquired and transported, and therefore, such gifts or donations affect commerce. It also would require that any deviations from the regulations be fully explained by the principal investigator and approved by the Committee. The plan may provide for the following exceptions (Sect. The Act specifies the composition of the committee, including the requirement that each committee must be composed of at least three members and that each committee must have at least one member who is a veterinarian and at least one who represents the community interest in proper animal care. 2.36(b)(2)). 2.11 Denial of initial license application. ", (g) "In instances where a research facility transfers ownership of a live random source dog or cat acquired from a dealer to another research facility, a copy of the certification required by paragraph (b) of this section must accompany the dog or cat transferred. The research facility has the authority to require additional training under Sec. (18) Environmental enhancement and psychological well-being of nonhuman primates (Section 3.81). L. 96-354). Many comments concerned the Animal Welfare regulations generally or conceptually. 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