[Federal Register Volume 64, Number 135 (Thursday, July 15, 1999)] [Proposed Rules] [Pages 38145-38150] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-18050] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 3 [Docket No. 98-121-1] Animal Welfare; Draft Policy on Environment Enhancement for Nonhuman Primates AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Draft policy statement and request for comments. ----------------------------------------------------------------------- SUMMARY: Under the Animal Welfare Act, our regulations require that dealers, exhibitors, and research facilities that maintain nonhuman primates develop and follow a plan for environment enhancement adequate to promote the psychological well-being of the nonhuman primates. We have developed a draft policy to clarify what we believe must be considered and included in the plan in order for dealers, exhibitors, and research facilities to adequately promote the psychological well- being of nonhuman primates. We are seeking public comment on the draft policy before we implement it. DATES: We invite you to comment. We will consider all comments that we receive by September 13, 1999. ADDRESSES: Please send an original and three copies of your comments to Docket No. 98-121-1, Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comments refer to Docket No. 98-121-1. Comments received may be inspected at USDA, room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons wishing to inspect comments are requested to call ahead on (202) 690-2817 to facilitate entry into the comment reading room. FOR FURTHER INFORMATION CONTACT: Natalie Roberts, Ph.D., Program Evaluation and Monitoring, PPD, APHIS, 4700 River Road Unit 120, Riverdale, MD 20737-1234, (301) 734-8937; or e-mail: Natalie.A.R[email protected]. SUPPLEMENTARY INFORMATION: The Animal Welfare Act (AWA) (7 U.S.C. 2131 et seq.) authorizes the Secretary of Agriculture to promulgate standards and other requirements governing the humane handling, housing, care, treatment, and transportation of certain animals by dealers, exhibitors, and other regulated entities. The Secretary of Agriculture has delegated the responsibility for enforcing the AWA to the Administrator of the Animal and Plant Health Inspection Service (APHIS). Regulations established under the AWA are contained in 9 CFR parts 1, 2, and 3. The APHIS Animal Care program ensures compliance with the AWA regulations by conducting inspections of premises with regulated animals. Subpart D of 9 CFR part 3 contains requirements for the humane handling, care, treatment, and transportation of nonhuman primates. Under subpart D, Sec. 3.81 requires that dealers, exhibitors, and research facilities that maintain nonhuman primates develop, document, and follow an appropriate plan for environment enhancement adequate to promote the psychological well-being of nonhuman primates. Section 3.81 further requires that the plan be in accordance with currently accepted professional standards, as cited in appropriate professional journals or reference guides, and as directed by the attending veterinarian. At a minimum, Sec. 3.81 requires the plan to address:The social needs of nonhuman primates known to exist in social groups; Enrichment of the physical environment of the nonhuman primates by providing means of expressing noninjurious species-typical behavior; Special considerations for infant and young nonhuman primates; nonhuman primates that show signs of psychological distress, are restricted in their activities, or are individually housed; and great apes weighing over 110 lbs. Further guidance and specific examples are provided in Sec. 3.81 for determining when social grouping of nonhuman primates is inappropriate and ways to provide environmental enrichment. In [[Page 38146]] addition, Sec. 3.81 places restrictions on the use of restraint devices and prescribes when and how individual nonhuman primates may be exempted from participation in the plan. History of APHIS Regulations on Psychological Well-Being of Nonhuman Primates The regulations in Sec. 3.81 were established as part of a final rule published in the Federal Register on February 15, 1991 (56 FR 6426-6505, Docket No. 90-218). The final rule stipulated that plans for promoting the psychological well-being of nonhuman primates must be implemented by August 14, 1991. The establishment of these regulations was in response to amendments to the Animal Welfare Act made by Congress in 1985. Among other things, the 1985 amendments directed the Secretary of Agriculture to promulgate new regulations for a physical environment adequate to promote the psychological well-being of nonhuman primates. Nonhuman primates include more than 240 species, ranging from the tiny marmoset to great apes. They live in different habitats in nature, and their nutritional, activity, social, and environmental requirements vary. As a result, the conditions appropriate for one species do not necessarily apply to another. In addition, the 1985 amendments to the Animal Welfare Act, while mandating that we establish regulations for a physical environment adequate to promote the psychological well-being of nonhuman primates, did not give us the authority to interfere with actual research. With these things in mind, we intentionally made the regulations regarding promotion of psychological well-being flexible. The regulations we established in Sec. 3.81 are performance standards, meaning they state a goal that must be met (an environment adequate to promote the psychological well-being of nonhuman primates) and provide minimum requirements on how to meet the goal. Within the minimum requirements, dealers, exhibitors, and research facilities have the flexibility to develop a plan that will address the specific needs of the nonhuman primates they maintain and, for research facilities, that will address the scientific needs of research. Further, what constitutes psychological well-being in each species and each primate does not lend itself to precise definition. After consultation with primate experts and using the accepted professional standards available at the time, we based the regulations on the concept that, to promote the psychological well-being of nonhuman primates, a balance of several factors or areas of concern must be addressed. As noted above, this concept, as set forth in Sec. 3.81, involves providing methods of social interaction with other nonhuman primates or humans; providing methods to physically and mentally stimulate the nonhuman primates and occupy some of their time; and considering the special needs of certain nonhuman primates, such as infants and young juveniles or great apes. Stipulating areas of concern that must be addressed, as opposed to more rigid design standards, allows dealers, exhibitors, and research facilities flexibility to tailor the plan so that it is appropriate to the species or individual being maintained. The performance standards in Sec. 3.81 require first and foremost that the plan for environment enhancement be in accordance with currently accepted professional standards, as cited in appropriate professional journals or reference guides, and as directed by the attending veterinarian. This allows flexibility for dealers, exhibitors, and research facilities in developing their guides as advances are made in the understanding of ways to assess and promote psychological well-being in nonhuman primates. Draft Policy on Psychological Well-Being of Nonhuman Primates In 1996, after 5 years of experience enforcing Sec. 3.81, we evaluated the effectiveness of the performance standards by surveying our inspectors about their experience in reviewing environment enhancement plans developed under Sec. 3.81. The results of our evaluation indicated that dealers, exhibitors, and research facilities did not necessarily understand how to develop an environment enhancement plan that would adequately promote the psychological well- being of nonhuman primates. In addition, there has been considerable disagreement in various sectors of the public over the adequacy of the performance standards in Sec. 3.81, as well as confusion among the regulated public concerning on what basis they will be judged by inspectors as meeting or not meeting the requirements. Our inspectors requested information and clarification on how to judge whether someone was meeting the requirements in Sec. 3.81. While we continue to believe that the flexibility of the performance standards in Sec. 3.81 is in the best interests of the animals covered by the regulations, we do believe that additional information on how to meet the standards in Sec. 3.81 is necessary. We have, therefore, developed a draft policy on environment enhancement for nonhuman primates. The draft policy appears at the end of this document. We intend this policy to be used by dealers, exhibitors, and research facilities as a basis in developing plans under Sec. 3.81 for environment enhancement to promote the psychological well-being of nonhuman primates. We based the draft policy on an extensive review of the available primate literature, professional journals, and reference guides. We also consulted veterinarians, primatologists, and our inspectors. The draft policy represents what we believe are the currently accepted professional standards for promoting the psychological well-being of nonhuman primates through enhancement of the primates' environment. We believe this draft policy will assist regulated entities by clarifying what actions we consider necessary in order to comply with the requirements of Sec. 3.81. We state in the draft policy that dealers, exhibitors, and research facilities who house nonhuman primates will meet the requirements of Sec. 3.81 if they develop and follow environment enhancement plans that are in accordance with the draft policy. However, we recognize that there may be other options that would also meet the requirements of Sec. 3.81. Our adoption of this draft policy would not prevent regulated entities from developing practices other than those in the draft policy, as long as those practices meet the requirements of Sec. 3.81. Likewise, our adoption of this draft policy would not prevent regulated entities from using alternative sources or research materials in developing their environment enhancement plans, as long as the resulting plans meet the requirements of Sec. 3.81. If a dealer, exhibitor, or research facility wants assurance that an alternative plan (not in accordance with the draft policy) is in compliance with Sec. 3.81, they may request approval of the plan in writing from the Deputy Administrator of Animal Care. The draft policy identifies five general elements that we believe are critical to environments that adequately promote the psychological well-being of nonhuman primates: Social grouping, social needs of infants, structure and substrate, foraging opportunities, and manipulanda. These five elements are represented in the minimum requirements in Sec. 3.81 concerning social grouping and environmental enrichment. The five elements, and detailed information provided for each, describe what we believe to be the currently accepted professional [[Page 38147]] standards to meet the minimum requirements in Sec. 3.81. We also state in the draft policy that facilities are encouraged to explore additional elements and innovations and to exceed the requirements of the draft policy and the regulations. In addition, we have prepared a report that describes the scientific basis for the draft policy and the methods we used in developing the draft policy, including a literature review and discussion and a list of references. You can obtain a copy of this report by contacting the person listed under FOR FURTHER INFORMATION CONTACT at the beginning of this document. The report can also be viewed at any Animal Care Regional Office and in our comment reading room. The address for our comment reading room appears in the ADDRESSES section at the beginning of this document. Finally, the report is posted on the Animal Care home page at http://www.aphis.usda.gov/ac/info.html. We are seeking public comment on the content of the draft policy before we implement it. The draft policy is as follows: Draft Policy on Environment Enhancement for the Psychological Well- Being of Nonhuman Primates The regulations in 9 CFR 3.81 require that dealers, exhibitors, and research facilities develop, document and follow an appropriate plan for environment enhancement adequate to promote the psychological well- being of nonhuman primates, and that the plan be in accordance with currently accepted professional standards as cited in appropriate professional journals or reference guides and as directed by the attending veterinarian. We have developed this policy to clarify what we believe must be considered and included in an environment enhancement plan developed under Sec. 3.81 in order to meet the requirement of adequately promoting the psychological well-being of nonhuman primates. We have based this policy on a review of the available primate literature, professional journals and reference guides, and the collective experience of field inspectors, veterinarians, and primatologists. Dealers, exhibitors, and research facilities who house nonhuman primates will meet the requirements of Sec. 3.81 if they develop and follow an environment enhancement plan (referred to below as ``plan'') in accordance with this policy. If a plan is not developed in accordance with this policy, the plan may or may not meet the requirements of Sec. 3.81. If a dealer, exhibitor, or research facility wants assurance that an alternative plan (not in accordance with this policy) is in compliance with Sec. 3.81, they may request approval of the plan in writing from the Deputy Administrator of Animal Care. Based on our research, we have identified five elements that are critical to environments that adequately promote the psychological well-being of nonhuman primates: A. Social Grouping B. Social Needs of Infants C. Structure and Substrate D. Foraging Opportunities E. Manipulanda The remainder of this policy contains what we believe are the currently accepted professional standards to address these five critical elements, based on our research and review of the available literature, as explained above. The first two critical elements, Social Grouping and Social Needs of Infants, are a clarification of Sec. 3.81(a), which deals with the impact of social grouping on psychological well-being. Structure and Substrate, Foraging Opportunities, and Manipulanda are critical elements which clarify Sec. 3.81(b), Environmental Enrichment. Facilities are encouraged to explore additional elements and innovations and to exceed what is in this policy. A. Social Grouping Section 3.81(a) requires that a plan must address the social needs of nonhuman primates of species known to exist in social groups in nature. According to our research, primates are clearly social beings and social housing is the most appropriate way to promote normal social behavior and meet social needs. In order to address the social needs of nonhuman primates under Sec. 3.81(a), the plan must provide for each primate of a species known to be social in nature to be housed with other primates whenever possible. The housing options listed below are listed in a hierarchy of preference, with group housing being the most desirable plan. Housing should maximize opportunities for a full range of species-appropriate contact, except that reproduction may be limited or prevented entirely. Social housing should be designed to reduce the risk of injury from others in the enclosure. Compatibility must be determined as described in 9 CFR 3.81(a)(3). Housing options include: 1. Housing in an enclosure with one or more compatible primates. For group-living species, species-typical groupings are strongly encouraged. 2. Housing in an enclosure without another compatible primate, but with the animal having the opportunity for continuous visual, auditory, olfactory, and tactile contact with another compatible primate (such as through adjacent wire mesh or bars). For primate species in which grooming other primates is an important social function, sufficient tactile contact range is particularly important. 3. Housing without the animal having the opportunity for continuous visual, auditory, olfactory, and tactile contact, but with such contact on a periodic basis, through scheduled social interaction with one or more compatible primates. 4. Housing without the animal having the opportunity for continuous visual, auditory, olfactory, and tactile contact with a compatible primate, but with daily positive interaction with compatible human care givers. The human contact should be of sufficient type and duration to compensate for restricted social housing. We do not consider basic routine husbandry or medical or experimental manipulation to be sufficient human contact. We consider pair or group housing (Option 1) to be the most desirable housing option and we expect this option to be used whenever possible. We consider this particularly important for chimpanzees, gorillas, gibbons, and siamangs, which seem to suffer particularly from being housed individually. If Option 1 is not utilized, the plan must provide an explanation and justification for each diminished degree of social interaction. Social housing also facilitates important primate behaviors associated with signals that communicate emotional states or other information between individuals. Acceptable reasons for choosing Options 2, 3, or 4 would include: 1. The health and well-being of the individual primate; 2. Documented unavailability of compatible individuals; 3. The scientific requirements of a protocol approved by an Institutional Animal Care and Use Committee (IACUC) (for registered research facilities); or 4. The animal's assignment to an IACUC-approved project that will result in euthanasia or disposition within a short period (normally less than 60 days). Virtually any social change can be stressful to the nonhuman primates. In order to effectively manage social groups and minimize stress, the plan should include procedures for introduction, separation, and socialization, including minimizing unnecessary separations for established [[Page 38148]] compatible pairs or groups, whether temporary or permanent, and minimizing the negative effects of necessary separations. If individual primates are strongly socialized toward humans and distressed by other primates, the plan should provide for daily, extensive positive human interaction in addition to that associated with routine husbandry, medical care, experimental manipulation, training, or exhibition. Without some socialization to humans, contact with humans becomes an environmental stressor for the primates, over which they have no control. When contact with human facility personnel is a necessary part of the primate's life, the plan must include a program of husbandry conditioning and habituation to human manipulation. This is particularly important for any primate subjected to frequent conscious manipulation or restraint that may cause more than momentary or slight pain or distress, or frequent chemical restraint to accomplish minor procedures or manipulations. B. Social Needs of Infants Section 3.81(c)(1) requires that special attention be given to infants and young juveniles. Nonhuman primate infants and their care- giving parents have specific social needs. The psychological well-being of nonhuman primate infants depends on appropriate infant development. In most situations, the optimal environment for infant development is one that allows the infant to remain with its biological mother through weaning in the company of a species-normal social group. Additionally, reproductive success (including reproductive behaviors, fertility, prenatal adequacy, parturition, and parental care) is generally considered to be one of the strongest indicators of psychological well- being in adult captive nonhuman primates. All facilities with one or more breeding groups of primates should include in their plan a program to ensure species-typical sensory, motor, psychological and social development of infants. The plan should also include criteria for removal of any infants from the care-giving parent(s) if necessary. Separation should be directed by the attending veterinarian or other qualified professional and should be customized to the characteristics of the individual primate. Infants should not be permanently removed from the care giving parent(s) before an age that approximates the age of infant independence in nature, except where necessary for the health and well- being of the infant or dam. Although we stress that it is important not to disrupt the bond between the infant and its parents, there may be situations when infants must be separated earlier than is optimal. When infants must be separated from the care giving parent(s) prior to the approximate age of separation in nature, our research indicates that at least the following separation procedures should be included in the plan in order to minimize distress and ensure appropriate sensory, motor, psychological, and social development of the infant: Details of separation procedures used to minimize distress for the infant and the care-giving parent(s); Details of any hand-raising or fostering practices. There should be specific provisions, in accordance with the professional literature, to provide the infant with a level of sensory, motor, psychological, and social stimulation approximating that which it would receive from its care giving parent(s), natal group and/or peer group under normal circumstances. Hand raising practices that are likely to be detrimental to the development of species-appropriate behavior or to the well-being of the individual at a later time, such as those involving social restriction from primates of their own species, should not be used; A suitable surrogate parent for artificially reared monkey or ape infants. The plan should include a program to develop and maintain species- typical social competence through exposure to peers and/or adults of the same or compatible species. Socialization to humans and to other animals, such as dogs, may be simultaneously maintained when desirable. C. Environmental Enrichment--Structure and Substrate The social, developmental, and physical environment are interdependent in ensuring psychological well-being of nonhuman primates. Section 3.18(b) requires that the physical environment in primary enclosures must be enriched by providing means of expressing noninjurious species-typical activities. The most basic components of the physical environment are the enclosure structure (its size, shape, and design) and the substrates within it (flooring, bedding, and furnishings, including perches, nest boxes, etc.). In order to promote psychological well-being for nonhuman primates, primary enclosures for housing and/or exercise need to be of adequate shape and design, and have adequate furnishings, to accommodate species-appropriate behaviors by all inhabitants. Each primate should be able to, at a minimum, engage in: 1. Species-typical postures and positions for resting, sleeping, feeding, exploration, and play; 2. Species-typical locomotion; and 3. Social adjustments. Primary enclosures should contain elevated resting structures appropriate for the species. The type, number, and orientation of the structures in each enclosure should be appropriate to the number and social arrangement of the animals in the enclosure. Structures should be positioned to facilitate social adjustments and not interfere with normal locomotion. Primates of species that normally hang from limbs and/or tails should be provided with structures and complexities that enable them to do so comfortably. Primates of species with long tails should be provided with sufficient vertical space to permit normal upright resting postures without restriction of tail position or placement of the tail outside the enclosure or into waste pans. Primates of species that normally rest or sleep in cavities, or which are nocturnal or partly nocturnal, should be provided with nest boxes or similar structures. Primates of species that construct nests for sleeping or resting should be provided with artificial or natural nest materials such as hay, browse, or blankets. Enclosures should be designed, constructed, and furnished so that individual primates may reasonably avoid other individuals or frightening stimuli. Flight distances, visual barriers, and placement of structures such as perches or shelters should be considered during design and furnishing. Primarily terrestrial species should have access to suitable flooring and resting areas. Patas monkeys should have regular access to large exercise areas that accommodate running. Primate species that scent-mark should be provided with suitable scent-retaining surfaces. The surfaces may be part of the cage structure, part of cage furniture, or in the form of temporary objects and should be replaced or sanitized as appropriate. Enclosures should be designed, constructed, and furnished to facilitate social introduction, reintroduction, separation, or temporary restraint. Aged, physically impaired, or debilitated individuals should be [[Page 38149]] provided with structures suited to their physical abilities. D. Environmental Enrichment--Foraging Opportunities In the wild, nonhuman primates spend a significant proportion of their time foraging for food. ``Working'' for food is one of the most frequently found species-typical activities for nonhuman primates. Captive nonhuman primates that are not provided with enough time- consuming foraging tasks may self-mutilate, over-groom, or become aggressive. As part of enriching the physical environment under Sec. 3.81(b), the plan should provide for each primate to have, on a daily basis, some type of time-consuming foraging opportunity. The foraging enrichment can include a wide variety of time-consuming activities. These activities may include providing something as simple as whole fruits or vegetables with high processing time, providing standard monkey biscuits in novel ways to increase food acquisition times, providing more complex types of devices such as puzzle feeders, or scattering food in substrates. Food items and foraging options should be chosen with consideration for the species and abilities of the individuals involved so that each primate can readily obtain its minimum daily nutritional requirements. The diet for each primate should contain a variety of tastes, smells, and textures. Gnawing or gouging wood should be provided for marmosets and tamarins. For primates on continuously restricted diets as part of medical treatment or experimental protocol, the plan should provide a substitution for foraging, meaning opportunities to engage in time- consuming cognitive activities or foraging involving nonfood rewards (such as ice cubes or toys). The cognitive activities should be voluntary--we do not consider activities that are part of experimental manipulation to be adequate. E. Environmental Enrichment--Manipulanda Manipulanda are objects that can be moved, used, or altered in some manner by the primate's hands. Manipulanda can stimulate several senses and permit the animal to experience novelty and a sense of control over part of its environment. Manipulanda have been shown to be effective in increasing species-appropriate behavior and decreasing abnormal behavior. As part of enriching the physical environment under Sec. 3.81(b), our research indicates that the plan should provide for each primate to have a variety of portable or moveable items for manipulation available to them. The size and type of item(s) and its presentation should be safe and suitable for the species, age, sex, and characteristics of the individuals. The number of items and their presentation should take into account hoarding or aggressive behavior by animals in a social group and changed as often as necessary to maintain appropriate novelty. Primate species that groom others of their own species but must be caged without tactile contact should have daily access to suitable objects or substrates for grooming. Considerations for Meeting the Critical Elements There are other criteria which our research showed must be considered in relation to all five critical elements: Documentation Novelty Control over the environment Sensory stimulation Exemptions Individuals in persistent psychological distress. Documentation The plan should be designed with consideration for the species, age, sex, health status, rearing, and behavioral history of the primate. The plan should document: Scientific justification for all aspects of the plan, including professional journals and reference guides consulted. Changes in the facility's primate population. Changes in the needs of individual primates. Assessments of the effectiveness of the program in promoting species-appropriate behavior. Novelty The plan should provide for appropriate levels of novelty in the items or strategies chosen. Novelty is variation in enrichment devices and strategies. Appropriate novelty includes both the physical properties inherent in any object or situation and the timing or duration that the novelty is provided. Novel items should be provided in sufficient quantity and located within the environment so as to be accessible to all primates. The cognitive abilities of primates should be considered in the choice of novelty provided. Novel stimuli should sustain their interest, encourage activity, and redirect inappropriate activity to behaviors appropriate for their species. Each facility should document in its plan how and with what frequency novelty is maintained. Control Over the Environment The plan should provide individual primates with the opportunity to exercise control over some aspects of their environment. Complex objects or environments that can be altered or controlled by the animals provide them with enhanced opportunities to utilize their cognitive abilities. Examples of control include opening doors and peep holes, moving indoors or outdoors, and influencing the temperature and lighting in the cage, as well as avoiding noxious stimuli. Sensory Stimulation The plan should provide for each of the five senses to be stimulated in a species-appropriate and non-distressing manner. Exemptions may be made for individuals with sensory impairment. The plan should provide for primates to be given the opportunity to avoid or distance themselves from objects that may be frightening. Levels of stimulation should not be excessive or discernibly distressing, and individuals must have the opportunity to avoid excessive exposure to such stimuli. Exemptions In accordance with Sec. 3.81(e), exemptions for individual primates from various aspects of the plan may be made as part of an IACUC- approved protocol. Section 3.81(e) also allows exemptions to be made by the attending veterinarian because of the animals health or condition or in consideration of its well-being. As required by Sec. 3.81(e), the basis for exemptions must be documented. Exemptions should be only to the extent and length of time necessary. Section 3.81(e) requires that exemptions be reviewed at least every 30 days by the attending veterinarian or, for IACUC-approved protocols, at least annually. Exemptions should be reviewed more often if appropriate to the circumstances and should be adjusted as circumstances change. If, due to medical treatment or experimental protocol, a critical element cannot be satisfied, additional enrichment must be provided as compensation. Individuals in Persistent Psychological Distress The plan should provide that, for primates in persistent psychological distress, a primate behaviorist or veterinarian with formal training and experience in primate behavior will be consulted. [[Page 38150]] Done in Washington, DC, this 9th day of May 1999. A. Cielo, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 99-18050 Filed 7-14-99; 8:45 am] BILLING CODE 3410-34-P