7 U.S.C. § 2143 — Standards and certification process for

Page 1412 TITLE 7—AGRICULTURE § 2141 search facilities shall continue to keep required records only for live dogs and cats. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1970 AMENDMENT Amendment by Pub. L. 91–579 effective one year after Dec. 24, 1970, see section 23 of Pub. L. 91–579, set out as a note under section 2131 of this title. § 2141. Marking and identification of animals All animals delivered for transportation, transported, purchased, or sold, in commerce, by a dealer or exhibitor shall be marked or identi- fied at such time and in such humane manner as the Secretary may prescribe: Provided, That only live dogs and cats need be so marked or identified by a research facility. (Pub. L. 89–544, § 11, Aug. 24, 1966, 80 Stat. 351; Pub. L. 91–579, § 12, Dec. 24, 1970, 84 Stat. 1562; Pub. L. 94–279, § 5, Apr. 22, 1976, 90 Stat. 418.) Editorial Notes AMENDMENTS 1976—Pub. L. 94–279 substituted ‘‘in commerce’’ for ‘‘affecting commerce’’. 1970—Pub. L. 91–579 applied marking and identifica- tion requirements to dealers and exhibitors for ani- mals, as defined, instead of only to dogs and cats when movements are affecting commerce, but limited such requirements for research facilities to only live dogs and cats. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1970 AMENDMENT Amendment by Pub. L. 91–579 effective one year after Dec. 24, 1970, see section 23 of Pub. L. 91–579, set out as a note under section 2131 of this title. § 2142. Humane standards and recordkeeping re- quirements at auction sales The Secretary is authorized to promulgate hu- mane standards and recordkeeping requirements governing the purchase, handling, or sale of ani- mals, in commerce, by dealers, research facili- ties, and exhibitors at auction sales and by the operators of such auction sales. The Secretary is also authorized to require the licensing of opera- tors of auction sales where any dogs or cats are sold, in commerce, under such conditions as he may prescribe, and upon payment of such fee as prescribed by the Secretary under section 2153 of this title. (Pub. L. 89–544, § 12, Aug. 24, 1966, 80 Stat. 351; Pub. L. 91–579, § 13, Dec. 24, 1970, 84 Stat. 1562; Pub. L. 94–279, § 5, Apr. 22, 1976, 90 Stat. 418.) Editorial Notes AMENDMENTS 1976—Pub. L. 94–279 substituted ‘‘in commerce’’ for ‘‘affecting commerce’’ in two places. 1970—Pub. L. 91–579 extended requirements for record- keeping and humane standards to exhibitors and opera- tors of auction sales, with such requirements to apply to animals as defined instead of only to cats and dogs when transactions in auction sales are affecting com- merce, and required operators of auction sales to ob- tain a license when he sells cats or dogs and such trans- actions are affecting commerce, upon payment of fee prescribed by the Secretary. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1970 AMENDMENT Amendment by Pub. L. 91–579 effective one year after Dec. 24, 1970, see section 23 of Pub. L. 91–579, set out as a note under section 2131 of this title. § 2143. Standards and certification process for humane handling, care, treatment, and trans- portation of animals (a) Promulgation of standards, rules, regulations, and orders; requirements; research facilities; State authority (1) The Secretary shall promulgate standards to govern the humane handling, care, treat- ment, and transportation of animals by dealers, research facilities, and exhibitors. (2) The standards described in paragraph (1) shall include minimum requirements— (A) for handling, housing, feeding, watering, sanitation, ventilation, shelter from extremes of weather and temperatures, adequate veteri- nary care, and separation by species where the Secretary finds necessary for humane han- dling, care, or treatment of animals; and (B) for exercise of dogs, as determined by an attending veterinarian in accordance with general standards promulgated by the Sec- retary, and for a physical environment ade- quate to promote the psychological well-being of primates. (3) In addition to the requirements under para- graph (2), the standards described in paragraph (1) shall, with respect to animals in research fa- cilities, include requirements— (A) for animal care, treatment, and practices in experimental procedures to ensure that ani- mal pain and distress are minimized, including adequate veterinary care with the appropriate use of anesthetic, analgesic, tranquilizing drugs, or euthanasia; (B) that the principal investigator considers alternatives to any procedure likely to produce pain to or distress in an experimental animal; (C) in any practice which could cause pain to animals— (i) that a doctor of veterinary medicine is consulted in the planning of such proce- dures; (ii) for the use of tranquilizers, analgesics, and anesthetics; (iii) for pre-surgical and post-surgical care by laboratory workers, in accordance with established veterinary medical and nursing procedures; (iv) against the use of paralytics without anesthesia; and (v) that the withholding of tranquilizers, anesthesia, analgesia, or euthanasia when scientifically necessary shall continue for only the necessary period of time; (D) that no animal is used in more than one major operative experiment from which it is allowed to recover except in cases of— (i) scientific necessity; or (ii) other special circumstances as deter- mined by the Secretary; and (E) that exceptions to such standards may be made only when specified by research protocol Page 1413 TITLE 7—AGRICULTURE § 2143 1 So in original. Probably should be ‘‘paragraph’’. 2 So in original. Probably should be followed by ‘‘in’’. and that any such exception shall be detailed and explained in a report outlined under para- graph (7) and filed with the Institutional Ani- mal Committee. (4) The Secretary shall also promulgate stand- ards to govern the transportation in commerce, and the handling, care, and treatment in con- nection therewith, by intermediate handlers, air carriers, or other carriers, of animals consigned by any dealer, research facility, exhibitor, oper- ator of an auction sale, or other person, or any department, agency, or instrumentality of the United States or of any State or local govern- ment, for transportation in commerce. The Sec- retary shall have authority to promulgate such rules and regulations as he determines nec- essary to assure humane treatment of animals in the course of their transportation in com- merce including requirements such as those with respect to containers, feed, water, rest, ventilation, temperature, and handling. (5) In promulgating and enforcing standards established pursuant to this section, the Sec- retary is authorized and directed to consult ex- perts, including outside consultants where indi- cated. (6)(A) Nothing in this chapter— (i) except as provided in paragraphs 1 (7) of this subsection, shall be construed as author- izing the Secretary to promulgate rules, regu- lations, or orders with regard to the design, outlines, or guidelines of actual research or experimentation by a research facility as de- termined by such research facility; (ii) except as provided 2 subparagraphs (A) and (C)(ii) through (v) of paragraph (3) and paragraph (7) of this subsection, shall be con- strued as authorizing the Secretary to promul- gate rules, regulations, or orders with regard to the performance of actual research or ex- perimentation by a research facility as deter- mined by such research facility; and (iii) shall authorize the Secretary, during in- spection, to interrupt the conduct of actual re- search or experimentation. (B) No rule, regulation, order, or part of this chapter shall be construed to require a research facility to disclose publicly or to the Institu- tional Animal Committee during its inspection, trade secrets or commercial or financial infor- mation which is privileged or confidential. (7)(A) The Secretary shall require each re- search facility to show upon inspection, and to report at least annually, that the provisions of this chapter are being followed and that profes- sionally acceptable standards governing the care, treatment, and use of animals are being followed by the research facility during actual research or experimentation. (B) In complying with subparagraph (A), such research facilities shall provide— (i) information on procedures likely to produce pain or distress in any animal and as- surances demonstrating that the principal in- vestigator considered alternatives to those procedures; (ii) assurances satisfactory to the Secretary that such facility is adhering to the standards described in this section; and (iii) an explanation for any deviation from the standards promulgated under this section. (8) Paragraph (1) shall not prohibit any State (or a political subdivision of such State) from promulgating standards in addition to those standards promulgated by the Secretary under paragraph (1). (b) Research facility Committee; establishment, membership, functions, etc. (1) The Secretary shall require that each re- search facility establish at least one Committee. Each Committee shall be appointed by the chief executive officer of each such research facility and shall be composed of not fewer than three members. Such members shall possess sufficient ability to assess animal care, treatment, and practices in experimental research as deter- mined by the needs of the research facility and shall represent society’s concerns regarding the welfare of animal subjects used at such facility. Of the members of the Committee— (A) at least one member shall be a doctor of veterinary medicine; (B) at least one member— (i) shall not be affiliated in any way with such facility other than as a member of the Committee; (ii) shall not be a member of the imme- diate family of a person who is affiliated with such facility; and (iii) is intended to provide representation for general community interests in the prop- er care and treatment of animals; and (C) in those cases where the Committee con- sists of more than three members, not more than three members shall be from the same administrative unit of such facility. (2) A quorum shall be required for all formal actions of the Committee, including inspections under paragraph (3). (3) The Committee shall inspect at least semi- annually all animal study areas and animal fa- cilities of such research facility and review as part of the inspection— (A) practices involving pain to animals, and (B) the condition of animals, to ensure compliance with the provisions of this chapter to minimize pain and distress to ani- mals. Exceptions to the requirement of inspec- tion of such study areas may be made by the Secretary if animals are studied in their natural environment and the study area is prohibitive to easy access. (4)(A) The Committee shall file an inspection certification report of each inspection at the re- search facility. Such report shall— (i) be signed by a majority of the Committee members involved in the inspection; (ii) include reports of any violation of the standards promulgated, or assurances re- quired, by the Secretary, including any defi- cient conditions of animal care or treatment, any deviations of research practices from originally approved proposals that adversely affect animal welfare, any notification to the facility regarding such conditions, and any corrections made thereafter; (iii) include any minority views of the Com- mittee; and Page 1414 TITLE 7—AGRICULTURE § 2143 3 So in original. Two subsecs. (f) have been enacted. (iv) include any other information pertinent to the activities of the Committee. (B) Such report shall remain on file for at least three years at the research facility and shall be available for inspection by the Animal and Plant Health Inspection Service and any funding Federal agency. (C) In order to give the research facility an op- portunity to correct any deficiencies or devi- ations discovered by reason of paragraph (3), the Committee shall notify the administrative rep- resentative of the research facility of any defi- ciencies or deviations from the provisions of this chapter. If, after notification and an oppor- tunity for correction, such deficiencies or devi- ations remain uncorrected, the Committee shall notify (in writing) the Animal and Plant Health Inspection Service and the funding Federal agency of such deficiencies or deviations. (5) The inspection results shall be available to Department of Agriculture inspectors for review during inspections. Department of Agriculture inspectors shall forward any Committee inspec- tion records which include reports of uncor- rected deficiencies or deviations to the Animal and Plant Health Inspection Service and any funding Federal agency of the project with re- spect to which such uncorrected deficiencies and deviations occurred. (c) Federal research facilities; establishment, composition, and responsibilities of Federal Committee In the case of Federal research facilities, a Federal Committee shall be established and shall have the same composition and respon- sibilities provided in subsection (b), except that the Federal Committee shall report deficiencies or deviations to the head of the Federal agency conducting the research rather than to the Ani- mal and Plant Health Inspection Service. The head of the Federal agency conducting the re- search shall be responsible for— (1) all corrective action to be taken at the facility; and (2) the granting of all exceptions to inspec- tion protocol. (d) Training of scientists, animal technicians, and other personnel involved with animal care and treatment at research facilities Each research facility shall provide for the training of scientists, animal technicians, and other personnel involved with animal care and treatment in such facility as required by the Secretary. Such training shall include instruc- tion on— (1) the humane practice of animal mainte- nance and experimentation; (2) research or testing methods that mini- mize or eliminate the use of animals or limit animal pain or distress; (3) utilization of the information service at the National Agricultural Library, established under subsection (e); and (4) methods whereby deficiencies in animal care and treatment should be reported. (e) Establishment of information service at Na- tional Agricultural Library; service functions The Secretary shall establish an information service at the National Agricultural Library. Such service shall, in cooperation with the Na- tional Library of Medicine, provide informa- tion— (1) pertinent to employee training; (2) which could prevent unintended duplica- tion of animal experimentation as determined by the needs of the research facility; and (3) on improved methods of animal experi- mentation, including methods which could— (A) reduce or replace animal use; and (B) minimize pain and distress to animals, such as anesthetic and analgesic procedures. (f) 3 Suspension or revocation of Federal support for research projects; prerequisites; appeal procedure In any case in which a Federal agency funding a research project determines that conditions of animal care, treatment, or practice in a par- ticular project have not been in compliance with standards promulgated under this chapter, de- spite notification by the Secretary or such Fed- eral agency to the research facility and an op- portunity for correction, such agency shall sus- pend or revoke Federal support for the project. Any research facility losing Federal support as a result of actions taken under the preceding sentence shall have the right of appeal as pro- vided in sections 701 through 706 of title 5. (f) 3 Veterinary certificate; contents; exceptions No dogs or cats, or additional kinds or classes of animals designated by regulation of the Sec- retary, shall be delivered by any dealer, research facility, exhibitor, operator of an auction sale, or department, agency, or instrumentality of the United States or of any State or local gov- ernment, to any intermediate handler or carrier for transportation in commerce, or received by any such handler or carrier for such transpor- tation from any such person, department, agen- cy, or instrumentality, unless the animal is ac- companied by a certificate issued by a veteri- narian licensed to practice veterinary medicine, certifying that he inspected the animal on a specified date, which shall not be more than ten days before such delivery, and, when so in- spected, the animal appeared free of any infec- tious disease or physical abnormality which would endanger the animal or animals or other animals or endanger public health: Provided, however, That the Secretary may by regulation provide exceptions to this certification require- ment, under such conditions as he may prescribe in the regulations, for animals shipped to re- search facilities for purposes of research, testing or experimentation requiring animals not eligi- ble for such certification. Such certificates re- ceived by the intermediate handlers and the car- riers shall be retained by them, as provided by regulations of the Secretary, in accordance with section 2140 of this title. (g) Age of animals delivered to registered re- search facilities; power of Secretary to des- ignate additional classes of animals and age limits No dogs or cats, or additional kinds or classes of animals designated by regulation of the Sec- retary, shall be delivered by any person to any Page 1415 TITLE 7—AGRICULTURE § 2144 1 So in original. Probably should be ‘‘section’’. intermediate handler or carrier for transpor- tation in commerce except to registered re- search facilities if they are less than such age as the Secretary may by regulation prescribe. The Secretary shall designate additional kinds and classes of animals and may prescribe different ages for particular kinds or classes of dogs, cats, or designated animals, for the purposes of this section, when he determines that such action is necessary or adequate to assure their humane treatment in connection with their transpor- tation in commerce. (h) Prohibition of C.O.D. arrangements for trans- portation of animals in commerce; excep- tions No intermediate handler or carrier involved in the transportation of any animal in commerce shall participate in any arrangement or engage in any practice under which the cost of such ani- mal or the cost of the transportation of such animal is to be paid and collected upon delivery of the animal to the consignee, unless the con- signor guarantees in writing the payment of transportation charges for any animal not claimed within a period of 48 hours after notice to the consignee of arrival of the animal, includ- ing, where necessary, both the return transpor- tation charges and an amount sufficient to re- imburse the carrier for all out-of-pocket ex- penses incurred for the care, feeding, and stor- age of such animals. (Pub. L. 89–544, § 13, Aug. 24, 1966, 80 Stat. 352; Pub. L. 91–579, § 14, Dec. 24, 1970, 84 Stat. 1562; Pub. L. 94–279, §§ 9, 10, Apr. 22, 1976, 90 Stat. 418, 419; Pub. L. 99–198, title XVII, § 1752, Dec. 23, 1985, 99 Stat. 1645.) Editorial Notes AMENDMENTS 1985—Subsec. (a)(1) to (3). Pub. L. 99–198, § 1752(a)(2), substituted pars. (1) to (3) for first two sentences of subsec. (a) which read as follows: ‘‘The Secretary shall promulgate standards to govern the humane handling, care, treatment, and transportation of animals by deal- ers, research facilities, and exhibitors. Such standards shall include minimum requirements with respect to handling, housing, feeding, watering, sanitation, ven- tilation, shelter from extremes of weather and tem- peratures, adequate veterinary care, including the ap- propriate use of anesthetic, analgesic or tranquilizing drugs, when such use would be proper in the opinion of the attending veterinarian of such research facilities, and separation by species when the Secretary finds such separation necessary for the humane handling, care, or treatment of animals.’’ Subsec. (a)(4) to (8). Pub. L. 99–198, § 1752(b), des- ignated third and fourth sentences of subsec. (a) as par. (4), designated fifth sentence of subsec. (a) as par. (5), and substituted pars. (6) to (8) for last sentence of sub- sec. (a) which read as follows: ‘‘Nothing in this chapter shall be construed as authorizing the Secretary to pro- mulgate rules, regulations, or orders with regard to de- sign, outlines, guidelines, or performance of actual re- search or experimentation by a research facility as de- termined by such research facility: Provided, That the Secretary shall require, at least annually, every re- search facility to show that professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anesthetic, an- algesic, and tranquilizing drugs, during experimen- tation are being followed by the research facility dur- ing actual research or experimentation.’’ Subsecs. (b) to (h). Pub. L. 99–198, § 1752(a)(1), (c), added subsecs. (b) to (f) and redesignated existing sub- secs. (b) to (d) as (f) to (h), respectively. 1976—Subsec. (a). Pub. L. 94–279, § 9, designated exist- ing provisions as subsec. (a) and inserted provisions au- thorizing Secretary to promulgate standards, rules and regulations relating to the transportation in com- merce, handling, care, and treatment of animals cov- ered under this chapter. Subsecs. (b) to (d). Pub. L. 94–279, § 10, added subsecs. (b) to (d). 1970—Pub. L. 91–579 added exhibitors to the enumera- tion of persons to be governed by promulgated stand- ards, added handling to the enumeration of activities covered, expanded existing standard for adequate vet- erinary care to include the appropriate use of anes- thetic, analgesic, or tranquilizing drugs by research fa- cilities when the use of such drugs is considered proper in the opinion of the attending veterinarian at such re- search facility, directed the Secretary to consult out- side consultants and experts in promulgating stand- ards, and inserted requirement of an annual report. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1985 AMENDMENT Amendment by Pub. L. 99–198 effective one year after Dec. 23, 1985, see section 1759 of Pub. L. 99–198, set out as a note under section 2131 of this title. EFFECTIVE DATE OF 1970 AMENDMENT Amendment by Pub. L. 91–579 effective one year after Dec. 24, 1970, see section 23 of Pub. L. 91–579, set out as a note under section 2131 of this title. § 2144. Humane standards for animals by United States Government facilities Any department, agency, or instrumentality of the United States having laboratory animal facilities shall comply with the standards and other requirements promulgated by the Sec- retary for a research facility under sections 1 2143(a), (f), (g), and (h) of this title. Any depart- ment, agency, or instrumentality of the United States exhibiting animals shall comply with the standards promulgated by the Secretary under sections 1 2143(a), (f), (g), and (h) of this title. (Pub. L. 89–544, § 14, Aug. 24, 1966, 80 Stat. 352; Pub. L. 91–579, § 15, Dec. 24, 1970, 84 Stat. 1563; Pub. L. 94–279, § 19, Apr. 22, 1976, 90 Stat. 423; Pub. L. 99–198, title XVII, § 1758, Dec. 23, 1985, 99 Stat. 1650.) Editorial Notes AMENDMENTS 1985—Pub. L. 99–198 substituted ‘‘sections 2143(a), (f), (g), and (h) of this title’’ for ‘‘section 2143 of this title’’ in two places. 1976—Pub. L. 94–279 inserted ‘‘and other require- ments’’ after ‘‘standards’’ in first sentence. 1970—Pub. L. 91–579 inserted provisions requiring fa- cilities of the United States exhibiting animals to com- ply with standards promulgated by Secretary under section 2143 of this title. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1985 AMENDMENT Amendment by Pub. L. 99–198 effective one year after Dec. 23, 1985, see section 1759 of Pub. L. 99–198, set out as a note under section 2131 of this title.