"Appendix A: USDA Final Rule on Environment Enhancement to Promote Psychological Well-Being--Section 3.81" is a chapter from: Kreger, Michael D. (March 1999). Environmental Enrichment for Nonhuman Primates Resource Gui d e. AWIC Resource Series No. 5. U.S. Department of Agriculture, National Agricultural Library, Animal Welfare Information Center, Beltsville, MD. E-mail: Contact us: http://www.nal.usda.gov/awic/contact.php .
The following are links to AWIC and other chapters in this publication:
In response to a Congressional amendment to the Animal Welfare Act, USDA must write regulations. The regulations explain what affected parties must do to comply with the amendment. USDA issues proposed rules which are published in Federal Regist e r and open for public comment. After comments are received, USDA issues a final rule in which changes to the proposed rule may or may not be made based on public input. The final rule below is USDA justification for the new regulations and respons e s to the many comments received by the department. The final rule is then incorporated into Title 9, Code of Federal Regulations.
02/15/91 Vol. 56, No. 32, Federal Register, Pages 6426-6505
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 3
[Docket No. 90-218]
Animal Welfare; Standards
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
Environment Enhancement to Promote Psychological Well-Being--Section 3.81
In proposed Sec. 3.81, titled "Environment enhancement to promote psychological well-being," we proposed that dealers, exhibitors, and research facilities be required to develop, document, and follow a plan for environment enhancement adequate to prom o te the psychological well-being of nonhuman primates. We proposed to require that the plan be in accordance with the currently accepted professional standards as cited in appropriate professional journals or reference guides and as directed by the attend i ng veterinarian. We also proposed to require that the plan be made available to APHIS, and, in the case of research facilities, to officials of any pertinent Federal funding agency. We proposed to require that the plan address certain specified areas, in c luding: (1) Social grouping; (2) environmental enrichment; (3) special considerations of nonhuman primates requiring special attention; and (4) restraint devices.
A very large number of commenters supported in general the promotion of psychological well-being in nonhuman primates. A number of others requested that "psychological well-being" in nonhuman primates be defined. A number of commenters stated either t h at the term is undefinable and cannot be measured as an improvement for nonhuman primates, that it is impossible to establish valid standards for the animals' psychological well-being, that the proposed standards might be detrimental to nonhuman primates , that the proposed regulations regarding psychological well-being were excessive, or that the proposed standards were not based on scientific analyses. As we discussed in our proposal, what constitutes psychological well-being in each species and each pr i mate does not lend itself to precise definition. As an agency, however, we are mandated by Congress to establish standards to promote the psychological well-being of nonhuman primates. As we discussed earlier, the information received from the expert com m ittee on primates, consultations with HHS, other experts in primates, and the large number of comments received on the subject, demonstrate that the psychological well-being of nonhuman primates involves a balance of several factors or areas of concern. T his concept involves sufficient space for the animals; methods to stimulate the animals and occupy some of their time, both physically and mentally (i.e., environment enrichment); and methods of social interaction with other nonhuman primates or humans.< / P>
The promotion of the psychological well-being of nonhuman primates is a critical component in our rewriting of the animal welfare regulations, and is one that we are specifically mandated to address under the Act. Statutorily, we have the responsibil i ty and obligation to establish such provisions as we believe are necessary for a physical environment to promote the animals' psychological well-being, but do not have the authority to interfere with actual research.
One commenter stated that the regulations should not limit resource materials for the development of environment enhancement plans to professional journals and reference guides. The regulations as proposed require adherence to such information sources as a minimum. They do not prohibit the use of other research sources in establishing the required plans.
A large number of commenters urged that the regulations include specific requirements for exercise and social grouping of nonhuman primates, as proposed in our original proposal. We disagree with the commenters that it would be in the best interests o f nonhuman primates to impose uniform rigid standards on all facilities. Because of the diverse needs of varying species and individual animals, it might actually prove harmful to establish the same set of specific standards for all animals.
A small number of commenters stated that any release of nonhuman primates for exercise and social interaction should be documented. We do not consider such documentation necessary for enforcement purposes. With the requirement for a written plan, and i nspections by Department personnel, we do not expect enforcement problems with the regulations as proposed.
We are making two additions to Sec. 3.81 as proposed to clarify our intent. That section requires that the plan for environment enhancement be made available to APHIS. It was our intent that the plan be made available upon request. We are therefore ad d ing language to Sec. 3.81 as proposed to clarify that intent. Additionally, we are specifying that the required plan for environment enhancement must be an appropriate one.
We proposed in Sec. 3.81(a) that the environment enhancement plan include specific provisions to address the social needs of nonhuman primates of species known to exist in social groups in nature. As proposed, such specific provisions must be in accor d ance with currently accepted professional standards, as cited in appropriate professional journals or reference guides, and as directed by the attending veterinarian.
A number of commenters opposed the proposed provisions regarding the social needs of nonhuman primates. Several commenters said the proposed provisions were vague and should be clarified, or that more specific criteria for meeting social needs should b e set forth. Many others offered specific recommendations for addressing the animals' social needs. The proposed provisions regarding the social needs of primates were intentionally written so as to allow some flexibility and professional discretion to i n dividual facilities in meeting the social needs of the animals. Exactly how the animals' social needs are met is of less importance than the fact that they are met.
One commenter stated that requiring that the social needs of nonhuman primates be met exceeds the intent of Congress. We do not agree with the commenter. In general, nonhuman primates are social animals, with the need for socialization constituting a s ignificant component of their psychological makeup. Promotion of the animals' psychological well-being requires that their social needs be addressed.
A small number of commenters stated that caging nonhuman primates for their lifetime has proven to be advantageous both to the animals' care and to their welfare. We disagree that individually housing nonhuman primates, without addressing their psycho l ogical and social needs, is adequate to promote their psychological well-being. Such practices will not be in compliance with these regulations.
A number of commenters stated that social housing should not be mandatory, but rather should be one of the possible methods of enriching the animals' environment. Other commenters stated that multiple housing of animals is inappropriate in most cases. One commenter stated that socialization should be based on individual housing that allows for visual and auditory contact among nonhuman primates, rather than group housing. One commenter stated that, under the regulations as proposed, facilities might b e precluded from housing only one nonhuman primate. We are making no changes based on these comments. The regulations as proposed do not specifically call for group housing of nonhuman primates. They do, however, require that the social needs of nonhuman p rimates be addressed. In most cases, we expect group housing to be the most efficient and appropriate method of ensuring that the animals' social needs are met.
Many commenters stated that social grouping would endanger the animals' welfare by increasing noise and fighting. We are making no changes based on these comments. The regulations in proposed Sec. 3.81(a)(3) require that nonhuman primates be compatibl e before being housed together. A number of other commenters, while supporting in general group housing of nonhuman primates, stated that in certain cases it might be inappropriate and detrimental. We agree that such situations might exist, and consider t h em to be already addressed in Sec. 3.81(a)(3) as proposed.
A small number of commenters stated that housing primates in groups will facilitate spread of infectious diseases. We consider the regulations as proposed adequate to prevent the spread of disease among group-housed animals. Section 3.81(a)(2) as prop o sed requires the isolation of nonhuman primates that have or are suspected of having a contagious disease. Additionally, the cleaning and sanitization requirements elsewhere in the regulations as proposed are designed to minimize disease introduction and spread.
A number of commenters expressed concern that group housing of nonhuman primates would result in increased physical and mental stress and trauma to animal handlers. As we discussed in our proposal, while we agree that housing primates in groups presen t s some logistical concerns that are not present when animals are housed individually, we believe that such concerns can be addressed by proper training of handlers and appropriate housing configurations.
A small number of commenters stated that meeting the requirements regarding the social needs of nonhuman primates will require facilities to increase their staffs. One commenter expressed concern that providing for group housing for primates will invo l ve significant expense. We do not agree that compliance with the regulations as proposed will necessarily require large staffing increases. In any event, some additional staffing, if necessary, would not be unreasonable in response to the amendments to t h e Act. Whether additional staffing is needed will depend on how the facility meets the social needs of the nonhuman primates, on the physical configuration of the facility, and on the facility's method of operations. In some cases, housing animals in gro u ps is less labor-intensive than housing them individually.
One commenter asserted that individually housing primates is appropriate in cases where the animal is used in experiments lasting 12 months or less. We are making no changes based on this comment. The Act does not distinguish between animals kept for a short term and those kept long-term, and requires minimum standards for all animals, regardless of the duration involved. The commenter presented no evidence to support the conclusion that individual housing for 12 months or less is not psychologically d istressing to nonhuman primates, and we are not aware of scientific data supporting such a conclusion.
A small number of commenters stated that the fact that primates socialize in nature neither indicates nor suggests that they are psychologically harmed by eliminating contact with other nonhuman primates. We disagree. In general, nonhuman primates are social animals by nature. In providing for the psychological well-being of nonhuman primates, such social needs must be taken into account. Other commenters stated that social grouping has not been proven to assure psychological well-being or to prevent d evelopment of stereotypical behaviors. We are making no changes based on these comments. No practices or regulations can guarantee the psychological well-being of nonhuman primates in all cases. However, the most compelling evidence available indicates t h at certain practices, including housing nonhuman primates in groups, can promote psychological well-being. In general, housing in groups promotes psychological well-being more assuredly than does individual housing. On the other hand, individual housing h as been demonstrated to give rise to significantly more stereotypical behavior than does group housing.
A small number of commenters recommended that compatible groups of nonhuman primates be required to remain together. Others recommended that primate infants remain with their dam for a minimum number of years, ranging from 2 years to 4 years. A small n umber of commenters recommended that the regulations allow primate families to be housed together. Others requested that such housing be required. One commenter stated that conspecifics should be housed together whenever possible. While we encourage such practices where possible, and nothing in the regulations as proposed prohibits them, we do not consider them practical in all cases. We are therefore making no changes based on these comments.
A small number of commenters suggested that behavioral scientists or animal psychologists may be more qualified than attending veterinarians to establish environment enhancement plans. Under the regulations as proposed, the attending veterinarian has r esponsibility for directing the development of the plan. However, nothing in the proposed regulations prohibits consultation with other animal experts. On the contrary, we expect the attending veterinarian to carry out whatever consultation and professio n al research he or she deems necessary to adequately advise the facility. One commenter stated that at research facilities, the environment enhancement plan should be designed based on consultation with and review by the Committee. As noted, the attending veterinarian may consult as necessary in directing development of the plan. Further, at research facilities, animal care programs are subject to annual review by the Committee.
A large number of commenters stated that group housing could significantly interfere with research where social grouping, or the lack of it, is a factor. Conversely, a very large number of commenters stated that exemptions for research should be allow e d only if it can be documented that social housing is interfering with the research. Under Sec. 2.38(k)(1) of part 2 of the regulations, research facilities are required to comply with the standards in part 3, except in cases where exceptions are specifi e d and justified in the research proposal to conduct the specific activity and are approved by the facility's Committee. This provision exists to safeguard approved research.
In order to make clear situations where group housing would not be appropriate, we proposed to specify in Secs. 3.81 (a)(1), (a)(2), and (a)(3) that the environment enhancement plan may provide that: (1) A nonhuman primate that exhibits vicious or ove r ly aggressive behavior, or is debilitated because of age or other conditions should be housed separately; (2) a nonhuman primate or group of nonhuman primates that has or is suspected of having a contagious disease must be isolated from healthy animals i n the colony as directed by the attending veterinarian; and (3) nonhuman primates may not be housed with other species of nonhuman primates or animals unless they are compatible, do not prevent access to food, water, and shelter by individual animals, and are not known to be hazardous to the health and well- being of each other. We also proposed that compatibility of nonhuman primates must be determined in accordance with generally accepted professional practices and actual observations, as directed by t h e attending veterinarian, to ensure that the animals are compatible. Additionally, we proposed that 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. A small number of commenters expressed opposition to all individual housing of nonhuman primates. We consider it obvious that situations will arise where housing in groups is self-e v idently more harmful than helpful, and are making no changes based on the comments.
A small number of commenters stated that the specific provisions described in the preceding paragraph should be deleted, because, according to the commenters, they all fall under the category of currently accepted professional standards. We consider t h e provisions in question minimum standards applicable in all situations. We are therefore making no changes based on the comments.
In proposed Sec. 3.81(b), we proposed to require that the plan discussed above include provisions for enriching the physical environment in primary enclosures by providing means of expressing noninjurious species-typical activities, and to provide tha t species differences should be considered when determining the type or methods of enrichment. We provided in the proposal that examples of environmental enrichments include providing perches, swings, mirrors, and other increased cage complexities; provid i ng objects to manipulate; varied food items; using foraging or task-oriented feeding methods; and providing interaction with the care giver or other familiar and knowledgeable person consistent with personnel safety precautions.
Many commenters stated that the regulations should list all of the specific areas that must be addressed in an environmental enrichment plan. Some commenters expressed concern that the lack of a guide in choosing environment enrichments could result i n prolonged experimentation at the expense of the primates' health and research funds. A number of commenters submitted specific practices that they believed should be included in achieving environmental enrichment. One commenter recommended that the Depa r tment set forth an exhaustive list of unacceptable practices. The provisions in Sec. 3.81 of the proposal set forth broad standards that must be met to ensure the psychological well-being of nonhuman primates. Section 3.81(b) is more specific, requiring e nrichment of the physical environment by providing means of expressing species-typical activities. Examples of such enrichment are provided. Beyond this, however, we do not consider it appropriate to attempt to set forth an exhaustive list of methods of a chieving environmental enrichment. Because of the many variables affecting how best to enrich the environment for species and animals that have different needs and that are held under differing conditions, such a listing would be unnecessarily restrictiv e , and would not allow for advances in animal behavioral research. Nor do we consider it possible or necessary to set forth a comprehensive list of unacceptable practices. Practices will be considered unacceptable if they do not promote compliance with th e standards in Sec. 3.81 as proposed.
Several commenters recommended that a panel of experts in primatology should be formed to develop standardized plans for environmental enrichment of nonhuman primates. For the reasons set forth in the preceding paragraph, we do not consider it appropr i ate to attempt to set forth a comprehensive listing of specific standards for environmental enrichment. A committee of the nature described by the commenters was convened prior to the initiation of this rulemaking process. We have drawn on the recommenda t ions of that committee in developing this rulemaking.
One commenter stated that the regulations should list what species-typical behaviors are required, because all behaviors are not possible in a cage. We do not consider such a change practical or necessary, and expect common sense, along with professio n al judgment, to assist in determining what behaviors can and should be promoted in caged animals.
One commenter stated that professional standards for environmental enrichment do not exist. We disagree. While we welcome additional research with regard to environmental enrichment, sufficient professional consensus already exists to make plans for s u ch enrichment appropriate. A small number of commenters stated that there is no definable species-typical behavior in captive nonhuman primates. We disagree. Species-typical behavior has been defined in both wild and captive populations, and sufficient d a ta exists to meet the standards as proposed.
In Sec. 3.81(c) of the proposal, we proposed that certain categories of nonhuman primates must receive special attention regarding enhancement of their environment. We proposed to require facilities to provide for the special psychological needs of (1 ) infants and young juveniles, (2) those that show signs of being in psychological distress through behavior or appearance, (3) those used in research for which the Committee-approved protocol requires restricted activity, (4) individually housed nonhuman primates that are unable to see and hear nonhuman primates of their own or compatible species, and (5) great apes weighing over 110 lbs. (50 kg).
As proposed, this special attention would be based on the needs of the individual species and in accordance with the instructions of the attending veterinarian. Some examples of special attention would be special feeding plans for juveniles, and incre a sed one-on-one care for animals showing psychological distress.
A small number of commenters requested that additional criteria be provided as to what constitutes special attention. We are making no changes based on these comments. The form this special attention must take will depend to a great extent upon what f o rm of environment enhancement is afforded all of the nonhuman primates in a facility under the required plan. Rather than restrict forms of special attention to a finite list, we consider it appropriate as proposed to base the special attention on the ne e ds of the individual species, in accordance with the instructions of the attending veterinarian.
Several commenters stated that, at research facilities, the Committee and not the attending veterinarian should determine what special attention is necessary. We consider it appropriate in general to give responsibility for determining appropriate spe c ial attention to the attending veterinarian. However, the regulations do not prohibit consultation with the Committee.
A number of commenters addressed the requirement for special attention for nonhuman primates that show signs of being in psychological distress through behavior or appearance. A small number of commenters recommended that the term "psychological distr e ss" be changed to "psychological pathology," because, according to the commenters, psychological distress can be of a transient or insignificant nature. We consider the term "psychological distress" to better convey our intent that facilities remedy even transient psychological disturbances than does the change recommended by the commenters, and are making no changes based on these comments. A small number of commenters stated that if a nonhuman primate exhibits stereotypical movements, such as hair pull i ng or similar signs of psychological distress, consultation with outside experts should occur. Under the regulations, a facility is required to provide adequate veterinary care to its animals. In certain cases, the attending veterinarian may consider it n ecessary to conduct outside consultation in administering such care. However, we do not consider it necessary or practical to include in the regulations a compendium of what constitutes adequate veterinary care. One commenter requested that the regulatio n s include a definition of "psychological distress." We consider the provision in question to be clear as written. Any behavior or appearance that would indicate abnormal stress must be addressed.
One commenter requested that the regulations include examples of restricted activity in research situations that would require special attention. We are making no changes based on this comment. The nature of restricted activity deemed necessary under a research protocol is subject to approval by the Committee. We do not consider it appropriate to attempt to enumerate in the regulations examples of restrictions that are the responsibility of the Committee.
Several commenters recommended that the provisions in Sec. 3.81(c)(5) as proposed be broadened to require special attention for great apes other than those weighing over 110 lbs. (50 kg). We are making no changes based on these comments. The special a t tention to be provided great apes over 110 lbs. is related to their need for additional space over that required for other great apes in Sec. 3.80. For this reason, we do not consider it necessary to require special attention for the smaller great apes.< / P>
We also proposed that the plan to be developed by the facility include provisions addressing restraint devices. We proposed that nonhuman primates must not be maintained in restraint devices unless required for health reasons as determined by the atte n ding veterinarian, or by a research proposal approved by the Committee at research facilities. As proposed, maintenance under such restraint would be limited to the shortest period possible. We proposed that, in instances where long-term (more than 12 ho u rs) restraint is required, the nonhuman primate must be provided the opportunity daily for unrestrained activity for at least one continuous hour during the period of restraint, unless continuous restraint is required by the research proposal approved by the Committee at research facilities.
A small number of commenters supported the proposed provisions regarding restraint devices as written. A small number of commenters stated that the proposed exercise period for restrained nonhuman primates is insufficient. Upon review of the comments, we continue to consider release for one continuous hour during the period of restraint adequate to promote the animal's well-being, and are making no changes based on these comments.
A small number of other commenters recommended that it be required that restrained nonhuman primates receive social contact with a conspecific primate during the exercise period, and that all animals placed in restraint devices with the approval of th e facility's Committee be inspected by the Committee prior to the Committee's granting approval for use of the restraint device. We are making no changes based on these comments. The special needs of restrained animals are already addressed in Sec. 3.81(c ) (3) as proposed. Further, the restraint of animals must be reviewed by the Committee at least twice annually, in accordance with part 2 of the regulations. Similarly, the recommendation of the commenter who suggested that the Committee be required to inv e stigate alternatives before approving research protocols is already addressed in Sec. 2.31(d)(1)(ii) of part 2 of the regulations.
A small number of commenters expressed concern that requirements for the exercise of restrained animals would interfere with research protocols. Some of these commenters recommended that requirements for restrained animals be left to the Committee. We
disagree that the provisions as proposed regarding restrained animals would interfere with research. Under Sec. 2.38(k)(1) of part 2 of the regulations, exceptions to the standards in part 3 may be made when such exceptions are specified and justified in
the proposal to conduct an activity and are approved by the Committee. For this reason, we are not adopting the recommendation of the commenter who stated that continuous restraint for more than 12 hours should be prohibited in all cases.
A small number of commenters requested that the regulations differentiate between restriction of movement and restraint. We are making no changes based on these comments. The regulations as proposed clearly pertain to maintenance in restraint devices. We consider the reference adequate to convey our intent as written.
In Sec. 3.81(e)(1) of the proposal, we proposed that the attending veterinarian may exempt individual nonhuman primates from participation in environment enhancement plans because of their health or condition, or in consideration of their well-being, a nd must document the basis of such exemptions for each nonhuman primate. The basis of the exemption would have to be recorded by the attending veterinarian for each nonhuman primate. Unless the basis for an exemption is a permanent condition, it would be required that the attending veterinarian review the exemption at least every 30 days.
We proposed in Sec. 3.81(e)(2) of the proposal that the research facility's Committee may exempt individual nonhuman primates from some or all of the environment enhancement plans, for scientific reasons set forth in the research proposal. We proposed to require that the basis of such exemption be documented in the approved proposal and be reviewed at appropriate intervals as determined by the Committee, but not less than annually.
We additionally proposed to require that records of any exemptions be maintained by the dealer, exhibitor, or research facility and be made available to USDA officials or officials of any pertinent funding Federal agency upon request.
A small number of commenters expressed opposition to what they termed "loopholes" in the regulations, which they stated would allow researchers to house animals in isolation merely by claiming necessity. As discussed above, we do not have the authorit y to interfere with approved research, and are making no changes based on these comments. Several commenters opposed exemptions of any sort. Permitting exemptions based on approved research protocols is consistent with the provisions of the Act that we no t interfere with the design, outlines, or guidelines of actual research. It may be necessary to the health and well-being of the animals to allow for exemptions for medical reasons. We are therefore making no changes based on these comments.
A number of commenters stated that the provisions for exemptions will require excessive paperwork, will be costly, and will subject the attending veterinarian's opinion to unqualified review. Throughout these regulations, we have attempted to minimize recordkeeping requirements. However, we continue to consider it necessary in facilitating inspection and enforcement that exemptions from the environment enhancement plan granted by the attending veterinarian be documented and be subject to review by the Department. We do not agree that it is necessary, however, as one commenter recommended, that documentation of exemptions be provided to the Department. Under the proposed regulations, these records must be made available to APHIS upon request. We consid e r that provision adequate to ensure proper inspection and enforcement.
A small number of commenters stated that exemptions should be reviewed by the attending veterinarian "as needed," rather than every 30 days as proposed. We are making no changes based on these comments. Because of the importance accorded the promotion of the psychological well-being of nonhuman primates under the Act, and because medical conditions in many cases change frequently, we consider it necessary and appropriate to ensure that exemptions to the environment enhancement plan be reviewed on a re g ular basis, to ensure that the exemptions are not in effect any longer than is necessary.
A small number of commenters stated that the facility should designate the individual most qualified to grant exemptions, because the attending veterinarian may not be the most qualified individual available with regard to animal behavior, and seldom h as contact with nondiseased primates. A small number of commenters stated that the Committee, and not the attending veterinarian, should have final authority at research facilities with regard to exemptions. We are making no changes based on these commen t s. The exemptions granted by the attending veterinarian will be for medical reasons, which he or she is qualified through training to assess.
Several commenters stated that the attending veterinarian should be permitted to exempt either individual nonhuman primates or groups of nonhuman primates from participation in the environment enhancement plan, and that exemptions for permanent condit i ons, including old age, should not need to be reviewed every 30 days. We do not agree. To ensure each nonhuman primate's participation in the environment enhancement plan to the fullest extent possible, exemptions need to be made on an individual basis, a ccording to the health, condition, and well-being of the animal. No blanket exemptions for groups or conditions are acceptable.
Several commenters recommended that it be required that exemptions made by the Committee be reviewed every 30 days. We do not agree with the commenters' recommendation. Exemptions made by the Committee will be made for reasons relating to an approved r esearch protocol. Such exemptions are not subject to as rapid change as exemptions for medical reasons, and do not need to be reviewed as often as those for medical reasons.
The following are links to AWIC and other chapters in this publication:
Animal Welfare Information Center
National Agricultural Library
The Animal Welfare Information Center, Contact us: http://www.nal.usda.gov/awic/contact.php
http://www.nal.usda.gov/awic/pubs/primates/primapdx.htm, April 13, 1999