Animal Welfare; Standards
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
EFFECTIVE DATE: This final rule shall become effective March 18, 1991. Plans for providing exercise of dogs in Sec. 3.8 and for promoting the psychological well-being of nonhuman primates in Sec. 3.81 must be implemented by August 14, 1991.
FOR FURTHER INFORMATION CONTACT: Dr. R. L. Crawford, Director, Animal Care Staff, Regulatory Enforcement and Animal Care, APHIS, USDA, room 565, Federal Building, 6505 Belcrest Road, Hyattsville, MD 20782, (301) 436-7833.
SUPPLEMENTARY INFORMATION:
This final rule revises the regulations contained in 9 CFR, part 3, subparts A and D. It is the result of an intensive effort that began in 1985 when Congress amended the Animal Welfare Act (7 U.S.C. et seq.) (the Act) in Public Law 99-198, "The Food Security Act of 1985," and directed the Secretary of Agriculture to promulgate certain new relations governing the humane handling, care, treatment, and transportation of animals by dealers, research facilities, and exhibitors, including requirements for exercise of dogs and a physical environment adequate to promote the psychological well- being of nonhuman primates. The final rule reflects the many years of experience of the Animal and Plant Health Inspection Service (APHIS), United States Department of Agriculture (the Department) in enforcing the Act and the Animal Welfare regulations (the regulations). We considered many thousands of public comments in deciding upon the content of the final rule. Our ongoing consultation with the United States Department of Health and Human Services (HHS), as well as other Federal agencies concerned with animal welfare, also contributed significantly to determining how best to fulfill our statutory mandate.
Due to the length and complexity of this document, it is broken down into general headings and specific subheadings where appropriate, to assist the reader. The supplementary information begins with a brief history of this rulemaking. Following that are our response to the comments we received regarding our August 15, 1990, revised proposal, and the changes we are making based on those comments and our ongoing consultation with HHS. Lastly, we address the concerns raised in the public comment letters regarding our economic assessments of the cost of implementing the proposed regulations.
The regulations are contained in title 9 of the Code of Federal Regulations, chapter I, subchapter A, parts 1, 2, and 3. Part I provides definitions of the terms used in parts 2 and 3. Part 2 sets forth the administrative and institutional responsibilities of regulated persons under the Act. Part 3 provides specifications for the humane handling, care, treatment, and transportation, by regulated entities, of animals covered by the Act. Subpart A of part 3 contains the regulations concerning dogs and cats; subpart B contains the regulations concerning guinea pigs and hamsters; subpart C contains the regulations concerning rabbits; subpart D contains the regulations concerning nonhuman primates; subpart E contains the regulations concerning marine mammals; and subpart F contains the regulations concerning other warmblooded animals regulated under the Act. APHIS issues and enforces the regulations, under authority of the Act, as amended.
On December 23, 1985, extensive amendments to the Act were enacted (see Pub. L. 99-198, "The Food Security Act of 1985."). Among other things, the Act directs the Secretary of Agriculture to promulgate standards to govern the humane handling, care, treatment, and transportation of animals by dealers, research facilities, and exhibitors, for exercise of dogs, and for a physical environment adequate to promote the psychological well- being of nonhuman primates. In order to comply with the amendments to the Act, APHIS published revisions of parts 1 and 2, and a proposal and a revised proposal to amend part 3, as discussed below.
Proposals to amend parts 1 and 2 of the regulations were published in the Federal Register on March 31, 1987 (52 FR 10292-10298, Docket No. 84-027, and 52 FR 10298-10322, Docket No. 84-010, respectively). We solicited comments for a 60-day period, ending June 1, 1987. The comment period was twice extended, ending on August 27, 1987. We received 7,856 comments, many of which stated that it was difficult to comment upon the proposals to amend parts 1 and 2 independently of our proposal to amend the standards in part 3. In response to comments, we published revised proposals on parts 1 and 2, along with a proposed rule to amend subparts A, B, C, and D of part 3, on March 15, 1989 (54 FR 10822-10835, Docket No. 88-013; 54 FR 10835-10897, Docket No. 88-014; and 54 FR 10897-10954, Docket No. 87-004, respectively).
We solicited comments on the interrelationship of parts 1 and 2 with part 3 for a 60-day period, ending May 15, 1989. Approximately 5,600 comments, received or postmarked by that date, were considered in preparing final rules for parts 1 and 2. (Any that also pertained to part 3 were considered as responding to the proposal to amend part 3.) The final rules to amend parts 1 and 2 were published in the Federal Register on August 31, 1989 (54 FR 36112- 36123, Docket No. 89-130, and 54 FR 36123-36163, Docket No. 89-131, respectively).
Most of our proposal with regard to part 3 dealt with revisions to the standards, based on our experience enforcing the regulations. We also proposed certain significant additions to the regulations, based on our mandate under the 1985 amendments to the Act. For example, we made significant additions to the regulations regarding the exercise of dogs and regarding a physical environment necessary to promote the psychological well- being of nonhuman primates. We solicited comments on the proposal to amend part 3 to be made for a 120-day period, ending July 13, 1989. A total of 10,686 comments were received in time to be considered. Included among the recommendations we received in response to the proposed rule were those submitted by HHS, with whom we continued our ongoing consultation. Of the total number of comments received, the overwhelming majority were in response to our proposed changes regarding subparts A and D.
Upon review of the comments regarding subparts B and C, we determined that, in general, our proposed revisions of those subparts were appropriate, with some minor modifications. On July 16, 1990, we published a document making final the proposed amendments to part 3 that pertain to subparts B and C (55 FR 28879-28884, Docket No. 89-175). However, due to the nature of the comments received in response to our proposed amendments regarding subparts A and D, and as a result of our ongoing consultations with other Federal agencies, we made certain major modifications to our March 15, 1989, proposal, and issued a revised proposal regarding those subparts on August 15, 1990 (55 FR 33448-33531, Docket No. 90-040).
We received a total of 11,932 comments in response to our revised proposal in time to be considered. Of the comments received, 509 were from dealers and exhibitors, 1,372 were from the research community, and 10,051 were from members of the general public. We included comments received from humane societies and groups representing the public in the areas of animal welfare and animal rights with comments from the general public.
Comments raising objections or suggesting changes to the revised proposal are discussed below in this supplementary information. Subheadings are provided in the supplementary information to guide the reader through the material. Section numbers are used in the subheadings wherever possible to further assist the reader. We have made a number of changes to our August 15, 1990, proposal in this final rule. Those changes are explained in the supplementary information below. The remaining provisions of our proposal are necessary to ensure the health and well-being of the animals in question, and we have included these remaining provisions in this final rule, except to make certain nonsubstantive wording changes for clarification.
In our discussion of the comments received, we use the term "proposed" or "proposal" when referring to the August 15, 1990, revised proposal. We use the term "original proposal" when referring to the March 15, 1989 proposal. When referring to the regulations in 9 CFR part 3 prior to the effective date of this final rule, we refer to the "existing regulations."
A large number of commenters expressed general support for the proposed provisions, and for more stringent regulations in general. A large number of commenters supported the proposed provisions that would establish requirements for increased space for animals. Many commenters also supported exercise for laboratory animals. A small number of commenters supported those provisions that they said would not interfere with research.
Conversely, very many commenters opposed the proposal in general. Many of these stated in general that the provisions that represented revisions to our March 15, 1989 proposal were unacceptable. A number of commenters stated generally that the proposal should be rewritten. A number of commenters expressed opposition to more stringent regulations. Many commenters recommended that no changes be made to the existing regulations. A number of commenters asserted that the proposed regulations go beyond ensuring the humane care and use of animals. Some of these commenters stated that the proposed standards exceed statutory authority and are inconsistent with Congressional intent. In this final rule, APHIS's statutory authority for the proposed regulatory amendments is set forth in the supplementary information, under the headings "General Background and Statutory Information" and "Statutory Authority for This Final Rule." Based on the statutory authority set forth, we believe ample authority exists for this rule.
A large number of commenters stated that the involvement of other Federal agencies in the rulemaking process is resulting in weaker animal welfare regulations. We do not agree that the regulations are being weakened. On the contrary, this final rule contains a significant number of provisions that are more stringent than those in the existing regulations. Additionally, two significant areas in the proposal--the exercise of dogs and the psychological well-being of nonhuman primates--are not in the existing regulations.
A number of commenters opposed in general what they considered the weakening of our original proposal in the revised proposal. We do not agree that the revised proposal represents a weakening of our original proposal. We gauge the strength of the animal welfare regulations by how well they effectuate the humane handling, care, treatment, and transportation of the animals in question. Our goal is to accomplish this end in the most reasonable and efficient way possible. We expect the provisions in this revised rule to attain the same ultimate goal as those in the proposed rule.
Many commenters stated that they favored more specific, rather than general standards. Of those favoring more specific standards, many expressed opposition to "performance standards," as contrasted with "engineering standards." Conversely, very many commenters stated that they were in favor of replacing engineering standards with performance standards. A small number of commenters asserted that including rigid engineering standards in the proposed regulations was contrary to the directives of Executive Order No. 12498. Many commenters stated that the proposed standards would interfere with research due to their rigidity and specificity, and would not allow the flexibility and innovations necessary for the optimal care and treatment of animals. Many commenters stated that rigid engineering standards are not suitable for regulating a wide range of facilities, interfere with professional judgment, rapidly become obsolete, and are not scientifically justified. In developing the proposed rule, we relied on our experience enforcing the regulations, on our scientific expertise, on information supplied by other Federal agencies, on research data regarding animal behavior, and on other information submitted by the public. Our goal was to establish regulations that would both promote the well-being of the animals in question and be enforceable. We did not consider it appropriate to couch all the proposed regulations either in the form of performance standards or engineering standards. In formulating the proposal, we attempted to identify those areas where variations in circumstances and animal behavior would make very specific standards less effective in promoting animal welfare than broader, goal-oriented standards. In those areas, we proposed to allow for flexibility in how the goal would be reached. In other areas, we determined that the needs of most of the animals housed, handled, or transported together were so similar that specific uniform standards were more appropriate, both for enforceability and for the well-being of the animals. Even in those areas, however, we recognized that in some cases the same specific requirements would not be appropriate for every animal involved. To accommodate these exceptions, we provided in many cases for professional discretion by the attending veterinarian. We believe that the provisions in this final rule represent a practical and enforceable blend of performance and engineering standards.
Many commenters stated that Congressional intent regarding the Act was for APHIS to avoid the use of performance standards. These commenters referred to correspondence between certain members of Congress and the United States Office of Management and Budget, in which the members of Congress urged that specific standards be adopted. We are aware of the correspondence referred to, and do not agree that it fully represents Congressional intent. On the contrary, the Congressional Conference Report on the Fiscal Year 1991 Agricultural Appropriations Bill contains the following language: "The conferees expect the Animal and Plant Health Inspection Service to incorporate performance based standards into its regulations when such performance based standards would not interfere with the establishment of a minimal level of care or the enforceability of the Act as Congress intended." As discussed above, we have therefore incorporated performance based standards where we considered them appropriate.
A number of commenters stated that researchers do not have the expertise to assess performance standards. We do not share the commenters' concern. The standards set forth in the proposal clearly state the ends that must be achieved. The regulated facilities, and not any particular researchers, is responsible for achieving these ends. We are confident each facility has or has access to the professional expertise adequate to ensure compliance with the regulations.
One commenter stated that the National Institutes of Health (NIH) Guide for the Care and Use of Laboratory Animals (Guide) must not be used as a minimum regulatory standard. Several commenters stated that it is not scientifically valid to adopt as Federal regulations all of the elements currently proposed to be adopted from the NIH Guide. Conversely, a large number of commenters stated that they concurred with coordination between certain provisions of the regulations and the NIH Guide. Section 15(a) of the Act requires that the Secretary of Agriculture consult and cooperate with other Federal agencies in establishing standards, and consult with the Secretary of HHS before issuing regulations (7 U.S.C. 2145(a)). However, notwithstanding our obligation to consult, we are mindful that Congress has entrusted the Department with the responsibility for establishing minimum requirements to carry out the Act's purposes, and for administering the Act because of our expertise in animal welfare matters. In the entire proposal, several areas contained provisions that paralleled those in the NIH Guide. In those cases, in fulfilling our responsibility to set forth regulations providing for animal welfare, we were also able to set forth regulations that harmonized with the NIH Guide.
One commenter stated that the proposed rulemaking would radically alter established Public Health Service/NIH policies. We disagree. The Public Health Service issues their Guidelines independent of our statutory mandate. This rule concerns the implementation of the Animal Welfare Act, for which the Secretary of Agriculture is responsible. In developing the proposed rule, we carried out our statutory obligation to consult with HHS. The consultations we conducted with that Department were comprehensive and intensive. A representative from the National Institutes of Health worked closely with APHIS to provide the HHS position on all issues affecting the research community. Through this consultation, we achieved what we understand to be a mutually satisfactory document. Based on our ongoing communication with HHS, that it can be readily implemented by the research community.
A number of commenters stated that the proposal was not stringent enough to meet the intent of Congress. We disagree. The intent of Congress was to provide for the enhanced well-being of the animals covered under the Act, and in particular to provide for the exercise needs of dogs and to promote the psychological well- being of nonhuman primates. Congress has provided the Department the authority to develop regulations to promote animal welfare. We believe the standards in this final rule provide the flexibility to accommodate varying conditions and procedures, while still providing the opportunity for exercise of dogs and an environment to promote the psychological well-being of nonhuman primates. In certain cases, based on information supplied by the public, we have made modifications to our proposal to promote better the well-being of the animals covered by the Act and the regulations.
A number of commenters stated that the proposed regulations are not supported by scientific documentation, that they are arbitrary and capricious, and that they provide no evidence either that the existing standards are inadequate or that the proposed standards will be of benefit to the animals' welfare. A number of commenters recommended that the proposal be rewritten to reflect available scientific information and current professional consensus. A smaller number of commenters expressed the opinion that APHIS does not have the technical competence to promulgate the proposed standards. The proposal we published was the result of a Congressional mandate to establish standards to provide for the exercise of dogs and for the psychological well-being of nonhuman primates, as well as the result of changes to the regulations that we considered appropriate based on over 20 years of enforcing those regulations. As noted above, in 1989 we published an initial proposal to amend and expand the regulations. We invited public comment on that proposal, soliciting whatever scientific data was available. Based on the information we received, and on our ongoing consultation with other Federal agencies, we made a number of significant modifications to that initial proposal. The basis for these changes was discussed in the preamble of the revised proposal that we published August 15, 1990. In that revised proposal, we again invited research data and other public comment. We have carefully reviewed all of the data and other information submitted to us, and, based on that information, have made certain modifications in this final rule. The basis for these modifications is discussed in the supplementary information of this final rule.
A small number of commenters recommended that separate standards be established for research, dealer, and exhibitor facilities. As we discussed in our proposal, while provisions do exist in the regulations to ensure that the standards in part 3 do not interfere with approved research, in general we do not believe that separate standards for different types of facilities are appropriate. The Act requires that we establish minimum standards for the humane care and well-being of animals. The fact that the standards we proposed are minimum assures that they will be adequate for each type of facility.
A large number of commenters stated in general that the scientific community is highly motivated to maintain the best possible laboratory animal care, because it is essential for humane reasons and to ensure productivity and accuracy. As discussed in the proposal, we agree that humane treatment of animals used in research promotes the well-being of the animals and the research value of the activities conducted. The standards set forth in part 3 of the regulations are minimum standards necessary for the well- being of animals housed, held, or maintained at any of the various categories of regulated entities. We encourage and applaud treatment of animals according to standards in excess of the minimum. However, as discussed above, we do not consider it appropriate or warranted to establish a separate set of standards for each type of regulated entity, as was suggested by these commenters.
Many commenters stated that the proposed regulations contain too many "loopholes" that allow facilities to interpret or circumvent standards, even though this is what Congress intended to avoid with its 1985 amendments to the Act. A small number of commenters stated that APHIS should not allow any exemptions from the regulations, even if approved by the Institutional Animal Care and Use Committee (Committee) at research facilities. We disagree. Throughout this rulemaking process, we have remained cognizant that section 13(a)(6) of the Act prohibits the Secretary from interfering with research design or the performance of actual research. Accordingly, the regulations provide research facilities with exceptions from the standards in part 3, when such exceptions are specified and justified in the proposal to conduct the activity. This provision is clearly set forth in part 2 of the regulations, and we do not agree, as one commenter recommended, that a similar provision is necessary as preface to part 3.
On the other hand, a number of commenters stated that APHIS exceeded statutory authority and Congressional intent by proposing regulations that interfere with research facilities' right to determine whether an activity is to be considered as a part of the performance of research. We disagree. These regulations are consistent with the Act's requirement that our regulations do not interfere with the design or performance of research. One commenter asked that we clarify which provisions could be departed from if approved in a research protocol, and which need to be adhered to in every case. The Act is clear on this issue. No provision in the regulations is to interfere with research that is part of an approved protocol.
A large number of commenters addressed the issue of primary enclosure size. Of those discussing primary enclosures, many supported the areas where our proposed provisions coincided with the NIH Guide. Very many commenters supported in general larger cages for animals. Many commenters stated that the minimum space requirements set forth in the proposal were insufficient. Based both on our experience enforcing the regulations and on animal research, we disagree that the minimum space requirements we proposed are insufficient. In the case of each of the animals whose treatment is regulated under subparts A and D--cats, dogs, and nonhuman primates--the specific minimum space requirements are at least as stringent as those in the existing regulations. In the case of cats, we have increased the space requirements from the existing regulations. In the case of dogs, we have maintained the existing floor space requirements for most dogs, have increased the space requirements for certain dogs, and have added height requirements. In the case of nonhuman primates, we have set forth space requirements that in effect closely parallel those in the existing regulations, and that in certain cases exceed the requirements in the existing regulations. In all cases, notwithstanding the specific primary enclosure dimensions required by the proposal, the regulations would require that the animal be able to move in a normal manner.
Several commenters stated generally that the proposed regulations would unduly restrict the exercise of professional judgment by the attending veterinarian and other laboratory animal professionals. We recognize that under certain circumstances, specific uniform requirements will not be most effective in promoting the well-being of all animals involved. To accommodate such situations, we have, in many cases, provided for discretion on the part of the attending veterinarian. We therefore disagree with the commenters that the provisions of this final rule will unduly restrict professional judgment.
Many commenters stated generally that the proposed regulations would have an adverse effect on animal welfare. We disagree. The regulations set forth in this final rule include the addition of certain requirements for the well-being of animals, as mandated by Congress, and amendments to the existing regulations that we consider necessary to improve animal care. We consider this final rule to be an improvement over the existing regulations.
A large number of commenters expressed concern that the proposed regulations would be unenforceable, given the current number of inspectors employed by the Department. We are making no changes based on these comments. In developing the proposed regulations, we were cognizant of the demands they would make on Department personnel, and are confident that the proposed provisions are workable and enforceable. Beyond that, we believe that they are necessary to enable us to meet our Congressional mandate to promote and protect the well-being of the animals covered under the Act. Many commenters stated more specifically that the Department would have difficulty enforcing the provisions regarding exercise requirements for dogs and the promotion of the psychological well- being of nonhuman primates. We disagree. Those particular areas of the regulations require facilities to develop plans for meeting the respective needs of dogs and/or nonhuman primates. In enforcing the regulations, an inspector will visually inspect the animals and the facility, and will review the required plans, as well as records of any exemptions for specific animals, to verify what he or she observes. Development of the plans will require involvement of the attending veterinarian, and in the case of research facilities, the Committee. We are confident that such professional involvement, combined with inspections by the Department, will be of greater benefit to the animals involved than rigid, across-the-board standards that do not take into account varying conditions and procedures.
One commenter stated that the attending veterinarian should have greater discretion in the formulation of animal care plans, and that all veterinarians should be board-certified. The regulations require that the attending veterinarian have knowledge of the species to be maintained at a facility. Additional requirements would be at the discretion of the facility.
One commenter stated that the regulations as proposed allow for too much "professional judgment" on the part of the attending veterinarian. The commenters questioned whether all veterinarians would have the integrity necessary to make sound professional judgments. Under the regulations, the attending veterinarian is responsible to the facility, which is responsible for compliance with the regulations. The facility is therefore dependent on the attending veterinarian's sound judgment to remain in compliance. Additionally, all decisions made by attending veterinarians will be subject to review by APHIS inspectors.
A large number of commenters stated that requirements for exercise of dogs and social interaction of primates must be spelled out clearly. We consider the requirements referred to be set forth clearly in our proposal. It is clear what ends are to be achieved. However, we do not consider it in the best interests of individual animals, many with differing needs, to restrict all facilities to the same specific set of procedures in achieving those ends.
In certain provisions in the regulations, the standards allow for adherence to "generally accepted practices." A small number of commenters stated that this term is vague, and that inspectors will be unable to evaluate whether a facility is in compliance. We disagree. Department inspectors are professional veterinary medical officers or animal health technicians, and are well trained in, and able to evaluate what constitute, generally accepted practices. A number of commenters stated that customary and generally accepted practices were precisely what Congress was objecting to when it required that the regulations be amended. We disagree with the general statement that generally accepted practices are harmful to animals. We particularly disagree with the allegation that accepted professional veterinary practices are inadequate. Even in the absence of Federal regulations regarding animal care, the veterinary profession adheres to its own professional standards to ensure the well-being of the animals it attends to. The changes that Congress mandated in the 1985 amendments to the Act were for the most part additions, not amendments, to the existing regulations. These additions, specifically relating to exercise for dogs and the psychological well-being of non-human primates, have been included in the regulations in such a way as to allow for the diversity of needs among species, breeds, individual animals, and conditions. A more rigid, inflexible approach could actually prove injurious to the animals.
A large number of commenters stated that facilities need to be able to establish their own performance standards, so that a facility can ensure adequate animal care and can accommodate special institutional needs and circumstances. Conversely, a number of commenters stated that the Department is illegally delegating its statutory duty to issue regulations to those being regulated. We disagree that the Department is inappropriately delegating its authority. Through the regulations set forth in this final rule, we are establishing standards for the exercise of dogs and the psychological well-being of nonhuman primates. Under the regulations, facilities are authorized only to develop specific procedures for meeting the standards.
One commenter stated that any plans or standard operating procedures developed by a Committee to comply with the regulations should be required to be submitted for Department approval. Under the regulations, such plans will be subject to review by Department inspectors. We therefore do not consider it necessary to require their submission for approval prior to implementation.
The regulations as proposed provided in certain cases for written documentation by facilities of procedures and exemptions. A number of commenters questioned whether APHIS would retain copies of this documentation. The commenters expressed concern that if APHIS took possession of copies, that information would then be available to the public under the Freedom of Information Act. According to the commenters, this would both allow competitors access to information associated with research, and provide potential terrorists with information regarding facilities. As a general rule, the written documentation required by the regulations will be inspected by APHIS at the facility, and will not be copied or removed. However, APHIS will have the option of removing such documentation if removal is necessary to carry out enforcement procedures.
One commenter recommended that the general public and any veterinarian be permitted access to records of research facilities to assist APHlS in monitoring these sites for compliance. Under the Act, enforcement is restricted to Department employees, and may not be delegated to members of the public.
A number of commenters stated that the proposed regulations would burden research facilities with unnecessary paperwork. On the other hand, a large number of other commenters opposed the elimination in the revised proposal of any recordkeeping requirements that appeared in the original proposal. One commenter called for daily or weekly documentation by facilities of compliance with the regulations. A number of other commenters stated that the proposed standards for laboratory animals were carefully drawn to avoid unnecessary paperwork. Under the Paperwork Reduction Act, we are required to minimize the paperwork burden on the public, consistent with the proper performance of our responsibilities under the Act. Cognizant of this obligation, we developed the proposed regulations with the goal of reducing paperwork requirements as much as possible, while still retaining the ability to document adequately conditions for enforcement purposes. Eliminating documentation requirements entirely would in certain areas hinder our ability to carry out our mandate to promote and enforce the welfare of animals covered under the Act. The recordkeeping and reporting requirements in this final rule represent what we consider the minimum necessary to enable us to enforce the regulations adequately.
Some commenters stated that the proposed regulations would eliminate the transport of animals by air. However, the commenters did not supply data to support these assertions. The purpose of amending the regulations is to help ensure the health and well- being of dogs and cats. In the absence of data indicating that other factors should override specific measures proposed to achieve this goal, we are making no changes to our proposal based on these comments.
A small number of commenters stated that the regulations should differentiate clearly between standards for transportation of shipped animals, and those traveling with passengers. With regard to carriers and intermediate handlers, the regulations specify that animals are covered by the regulations when "accepted" by those entities for transport. If these animals are in the possession of individuals in passenger areas, they are not subject to the regulations. Several commenters stated that the transportation standards should be clarified as to "transport in commerce" and "transport between buildings." We do not consider such a distinction necessary. Regulated animals must be handled in compliance with the standards at all times.
Several commenters stated generally that the proposed standards would result in an increased risk of disease and injury to both humans and animals. We believe that the proposed regulations should pose little increased risk if proper medical, health, husbandry, and safety procedures are followed. Whatever risk might exist will be minimized by the provisions in this final rule that allow for professional judgment as to the health and safety needs of individual animals, breeds, and species.
A small number of commenters stated that standards for temperature ranges should be as uniform as possible throughout the regulations to avoid confusion. In many areas in this final rule, based on information we received from the public, we have made changes to standardize allowable temperature ranges. These changes are discussed in the supplementary information of this final rule. One commenter recommended that all temperature and humidity standards be deleted from the regulations, and be replaced with general performance standards. We disagree with the commenter with regard to temperature requirements. Although the needs and tolerances of individual animals allow for some variation in acceptable temperature levels, certain upper and lower limits exist that are applicable to animals in general. With regard to humidity, the regulations as proposed already provide for professional discretion in determining appropriate humidity levels.
A number of commenters stated that environmental and temperature standards for animals should be similar to human standards until comfort indices for various species can be established. We disagree with the commenters. Differences among species do not allow for accurate cross-species comparisons.
One commenter stated that allowing for flexibility or innovation, as provided in certain cases in the regulations, is inappropriate when dealing with minimum standards. We disagree. The regulations include minimum standards, as required by law. In allowing for flexibility and innovation, we are simply allowing regulated entities some latitude in determining how to satisfy those minimum requirements.
One commenter stated that the regulations would create an adversarial relationship between veterinarians and researchers. Several commenters stated that under the proposed regulations, the attending veterinarian and Committee would become an enforcement agent of APHIS, which is not authorized by the Act. One commenter opposed the involvement of the Committee in the approval of procedures, because, according to the commenter, this usurps management's role and exceeds APHIS's statutory authority. Under the regulations, the research facility is responsible for ensuring that the regulations are met. Under the regulations, the attending veterinarian and the Committee are to provide professional judgment to the facility. We do not consider this an adversarial relationship, nor do we consider it as delegating enforcement authority to either the attending veterinarian or the Committee.
A small number of commenters stated that many of the proposed provisions would be used to eliminate animals from biomedical research. As we discussed in our proposal, history does not support such an assertion. Concerns regarding the elimination of animals from research were raised in 1966 and 1967 when the Act was first enacted and regulations were promulgated to implement it. To the contrary, however, tremendous advances in human and animal health have been made possible through continued support for biomedical research. In enacting the 1985 amendments to the Act, Congress specifically found that the use of animals is instrumental in certain research and education (7 U.S.C. 2131(b)). We believe that the provisions of this rule will effectuate the intent of Congress without imposing an unnecessary, unreasonable, or unjustified financial burden.
Several commenters expressed concern that the proposed regulations would discourage young people from entering medical research fields. We disagree. We believe that greater concern for the humane care and use of animals may in fact encourage new scientists and foster greater support for biomedical research throughout our society.
One commenter stated that the phrasing of the proposed regulations indicated application to non-animal areas. In certain cases, such as housekeeping standards, application to non-animal areas was intentional, because the condition of a premises can have an impact on the animals housed at the facility. In certain other cases, such as temperature requirements in housing facilities, qualifying language is included to make it clear that the standards need be met only when animals are present. We believe that the remainder of the proposed provisions express their intent clearly as to which areas of a facility, conveyance, or operation would be affected.
Several commenters recommended that the proposed regulations include an index to allow easier retrieval of information. We do not believe it is necessary to include an index in the regulations. Each of the subparts designates the types of animals it covers. Within each subpart, the contents of each section are indicated by a section heading. These headings are set forth in a table of contents at the beginning of each subpart. We believe that this format provides adequate reference to the contents of the regulations.
Several commenters requested that, in developing a final rule, the Department consider all comments received on previous proposed standards, as well as those received on our most recent proposal. We take seriously our responsibility under the Administrative Procedure Act to consider each comment timely received in response to proposed rulemaking. Accordingly, we have reviewed all such comments in the process of developing and modifying the rulemaking that is culminating in this final rule.
One commenter stated that all pet animal businesses should be covered by the regulations. The regulations in subparts A and D apply to those entities specified under the Act as being subject to its provisions. Under the Act, certain retail stores that sell pet animals are subject to the Act and the regulations. Other commenters stated that humane societies, animals rights organizations, and other special interest groups should be subject to the regulations. Such entities are not specified under the Act as being subject to its provisions, and therefore are not subject to the regulations unless they also act as dealers, exhibitors, research facilities, intermediate handlers, or carriers.
Several commenters stated either that the proposed regulations were written in a manner not understandable by the general public, thereby making comments on them difficult, if not impossible, or that the regulations should be reformatted or rewritten to improve their clarity. Based on the great number of comments we received addressing both specific and general provisions set forth in the proposal, we believe that in general the public found the proposed provisions understandable.
A large number of commenters addressed the issue of when the regulations should become effective. Several commenters expressed the opinion that the Department is obligated to make the amended regulations effective upon publication of this final rule. One commenter stated that the Department has already exceeded the time during which it was legally obligated to establish new regulations. Many more commenters called for a delay in the effective date, in order to allow time for adequate planning and financing. The commenters requesting a delay recommended that the regulations, particularly those provisions regarding minimum space requirements, become effective from 1 to 5 years after publication. A small number of commenters requested that primary enclosure space requirements be "grandfathered" in, to allow use of existing primary enclosures that are not in compliance with the new standards, until those enclosures would otherwise need replacement.
We disagree that the Department has illegally delayed publication of this final rule. On the contrary, the Department has diligently pursued the promulgation of these regulations with as much speed as their complexity allows. We are keenly aware of the economic impact these amended regulations will have on regulated entities. However, we are obligated to establish standards to promote the well-being of the animals protected by the Act, notwithstanding the fact that expenses will be incurred by regulated facilities in complying with the regulations. We are also aware of our obligation under Executive Order 12291 to minimize the economic impact of these rules on affected entities. In recognition of this responsibility, and of the practical delays that will necessarily be associated with complying with certain of the new requirements, we are providing that the facility plans for providing exercise of dogs, and for promoting the psychological well-being of nonhuman primates, must be developed and implemented within 180 days of the publication date of this final rule.
Many commenters pointed out that several of the new requirements would require affected facilities to make extensive structurally related changes in order to be able to comply with the new regulations. We believe those comments are well-founded and, therefore, in order to allow affected facilities the time necessary to make such changes, we are providing in this rule that regulated persons have until February 15, 1994, to comply with a few, specific provisions. These provisions appear in this rule in the following places:
1. Section 3.6(b)(1)(ii)(A) through Sec. 3.6(b)(1)(ii)(C) (redesignated from Sec. 3.6(b)(1)(i) through Sec. 3.6(b)(1)(iii) in the proposed rule), regarding minimum space requirements for primary enclosures containing cats;
2. Section 3.6(c)(1)(iii), regarding height requirements for primary enclosures containing dogs;
3. Section 3.6(c)(2)(ii) (redesignated from Sec. 3.6(c)(2) in the proposed rule), regarding perimeter fences surrounding dogs kept on tethers;
4. Section 3.77(f), regarding perimeter fences surrounding nonhuman primates housed at sheltered housing facilities;
5. Section 3.78(d), regarding perimeter fences surrounding nonhuman primates housed at outdoor housing facilities; and
6. Section 3.80(b)(2)(i) through Sec. 3.80(b)(2)(iv) (redesignated from Sec. 3.80(b)(1), Sec. 3.80(b)(2), Sec. 3.80(b)(4), and Sec. 3.80(b)(5), respectively, in the proposed rule), regarding minimum space requirements for primary enclosures containing nonhuman primates.
Because this new rule replaces the current standards, we are providing in this rule that, where standards currently exist with regard to the provisions listed above, those existing standards must be complied with during the period prior to February 15, 1994. This will enable us to maintain the standards necessary for the well-being of those animals whose care will be affected by the need for structural changes. Although we are providing additional time to comply with those new standards that require extensive structural changes, it is nevertheless our intent to encourage facilities to make those changes and come into compliance with the new standards as soon as possible.
Regulations for humane handling, care, treatment, and transportation of dogs and cats are contained in 9 CFR part 3, subpart A. These regulations include minimum standards for handling, housing, feeding, watering, sanitation, ventilation, shelter from extremes of weather and temperature, veterinary care, and transportation.
It should be noted that the regulations, as discussed in this final rule, apply only to live dogs and cats. In our August 15, 1990, proposal, we proposed to revise and rewrite the existing regulations based on our experience administering them. We also proposed to amend our regulations to add requirements for the exercise of dogs. This is specifically required by the 1985 amendments to the Act. (See 1752, 99 Stat. 1645, Pub. L. 99-198, amending section 13 of the Act). We discuss below each topic covered in our proposal.
Several commenters recommended that adequate provisions for exercise and socialization be provided for cats as well as dogs. As we discussed in our proposal, one of our specific obligations under the 1985 amendments to the Act was to establish requirements for the exercise of dogs. In response to that mandate, we included such provisions in our proposal. However, the Act does not specifically require that we establish exercise requirements for cats, and based on the information we have reviewed, we do not feel it is necessary or appropriate to require exercise and socialization for cats.
Existing Secs. 3.1 through 3.3 provide requirements for facilities used to house dogs and cats. Existing Sec. 3.1, "Facilities, general," contains regulations pertaining to housing facilities of any kind. It is followed by existing Sec. 3.2, "Facilities, indoor," and Sec. 3.3, "Facilities, outdoor." In our proposed rule, we proposed to amend these sections to provide for an environment that better promotes the health, comfort, and well- being of dogs and cats. We also proposed to add sections that provide regulations specifically governing two other types of facilities used to house dogs and cats--sheltered housing facilities, and mobile or traveling housing facilities. The term "sheltered housing facility" is defined in part 1 of the regulations as "A housing facility which provides the animals with shelter; protection from the elements; and protection from temperature extremes at all times. A sheltered housing facility may consist of runs or pens totally enclosed in a barn or building, or of connecting inside/outside runs or pens with the inside pens in a totally enclosed building." The term "mobile or traveling housing facility," also included in part 1, is defined as "a transporting vehicle such as a truck, trailer, or railway car, used to house animals while traveling for exhibition or public education purposes."
Some of the regulations we proposed for housing facilities are applicable to housing facilities of any kind. As in the existing regulations, we proposed to include these standards of general applicability in one section, proposed Sec. 3.1, that would also include many of the provisions in existing Sec. 3.1. Additionally, we proposed amendments to the existing regulations that are specific to particular types of housing facilities, and included those provisions in separate sections of the proposed regulations. In some cases where the existing regulations would have been unchanged in substance, we made wording changes to clarify the intent of the regulations.
Several commenters recommended that we require that housing facilities comply with Federal, State, and local laws and regulations relating to housing facilities for dogs and cats, so as to allow uniform enforcement by various jurisdictions. We are making no changes based on these comments. We are authorized under the Act to establish minimum standards for animal welfare. This mandate is different than those under other Federal, State, and local laws.
One commenter requested that we combine the provisions regarding sheltered housing facilities and outdoor housing facilities to avoid confusion over which is which. As defined in part 1 of the regulations, sheltered and outdoor housing facilities are two distinct types of facilities. Because of the differences between the two, we consider separate regulations necessary for each.
Housing Facilities; Structure; Construction--Section 3.1(a)
We proposed in Sec. 3.1(a) to require that housing facilities for dogs and cats be designed and constructed so that they are structurally sound. We proposed that they must be kept in good repair, and that they must protect the animals from injury, contain the animals securely, and restrict other animals and unauthorized humans from entering. A small number of commenters specifically supported these provisions as written. A large number of commenters addressed the issue of restricting the entrance of unauthorized humans, stating that the responsibility for maintaining adequate security at a facility belongs to the facility, and not to the Department of Agriculture. Others were concerned that, even if the facility made reasonable efforts to prevent the entry of unauthorized humans, the facility would still be liable for the entry of trespassing individuals. Because, unlike nonhuman predators and pests, it may be virtually impossible to prevent the unauthorized entry of humans, it will not be a violation of these regulations for facilities to fail to prevent such entry. In this final rule, we are therefore removing the requirement, as proposed in Secs. 3.1 (a) and (b), that facilities restrict the entry of unauthorized humans.
A small number of commenters stated that the provision that facilities restrict the entry of other animals was unnecessarily stringent. One commenter stated that reasonable efforts to comply with this provision should be sufficient. Others requested clarification of the definition of "other animals." We continue to believe that the provision is adequate as written. Unlike the forced entry of unauthorized humans, entry by other animals can be prevented by structural safeguards. Our implicit intent in requiring that other animals be restricted from entering the facility was to bar the entry of animals that could be detrimental to the health and well-being of the animals housed at the facility.
One commenter recommended that facilities be required only to reasonably protect animals from injury. We are making no changes based on this comment. We do not consider it unreasonable to require facilities registered or licensed under the Act to ensure the well-being of the animals in their custody.
Housing Facilities: Condition and Site--Section 3.1(b)
In proposed Sec. 3.1(b), we proposed to add the requirement that a dealer's or exhibitor's housing facilities be physically separated from any other business. When more than one entity maintains facilities on the premises, the increased traffic, equipment, and materials in proximity to the animals can be detrimental to the animals' well-being. Also, in cases where more than one entity maintains animals on a premises, it can be difficult to determine which entity is responsible for which animals and for the overall conditions. To avoid this difficulty, we proposed to require that housing facilities other than those maintained by research facilities and Federal research facilities be separated from other businesses. We did not propose to impose this requirement on research facilities, because they are often part of a larger sponsoring establishment, such as a university or pharmaceutical company, and responsibility for animal and site conditions rests with that establishment. Therefore, we have not encountered the enforcement difficulties noted above with respect to research facilities. One commenter specifically supported these provisions as written. Several commenters recommended that we require that all holding facilities and broker operations be operated in a building separate from the owner's dwelling or living quarters, with the exception of administrative offices. We do not consider the location of a licensee's dwelling relevant to the welfare of the animals housed in a facility, and therefore are making no changes based on this comment.
We also proposed in Sec. 3.1(b) to require that housing facilities and areas used for storing animal food and bedding be kept free of any accumulation of trash, waste material, junk, weeds, and other discarded material, in order to prevent an unsanitary condition and problems with diseases, pests, and odors. The need for orderliness applies particularly to the areas where animals are maintained in the housing facilities. Under our proposal, these areas would have to be kept free of clutter, including equipment, furniture, and stored material, but could contain materials actually used and necessary for cleaning the area, and fixtures or equipment necessary for proper husbandry practices and research needs.
A small number of commenters took issue with these proposed provisions. One commenter stated that weeds are not necessarily detrimental to the welfare of animals. Others recommended that we prohibit the conditions described only when they might negatively affect the health and welfare of the animals, or that we reword the proposed provision for clarity. We are making no changes based on these comments. While weeds themselves may not be detrimental, they interfere with such necessary practices as cleaning and rodent control. We continue to believe that the wording as proposed is necessary and enforceable.
Housing Facilities: Surfaces; General Requirements--Sections 3.1(c) (1) and (2)
We included in proposed Sec. 3.1(c) requirements concerning housing facility surfaces that are common to all types of facilities. We proposed to include requirements specific to particular types of facilities in separate sections. In Sec. 3.1(c)(1), we proposed to require that the surfaces of housing facilities either be easily cleaned and sanitized, or be removable or replaceable when worn or soiled. These provisions also applied to houses, dens, and other furniture-type fixtures or objects within the facility.
Proposed Sec. 3.1(c)(1) also required that any surfaces that come in contact with dogs and cats be free of jagged edges or sharp points that might injure the animals, as well as rust that prevents the required cleaning and sanitization. We proposed to allow rust on metal surfaces, as long as it is not excessive and does not reduce structural strength or interfere with proper cleaning and sanitization.
We proposed in Sec. 3.1(c)(2) to require that all surfaces be maintained on a regular basis and that surfaces that cannot be easily cleaned and sanitized be replaced when worn or soiled.
A small number of commenters specifically supported these provisions as written. One commenter expressed the opinion that the provisions in proposed Sec. 3.1(c)(1) were redundant with the requirements in proposed Sec. 3.10. We disagree. The requirements in proposed Sec. 3.1(c)(1) are structural requirements for housing facilities. The provisions in proposed Sec. 3.10 pertain to cleaning and sanitization.
One commenter stated that rusted areas cannot be adequately sanitized, and that rust affects structural strength and creates harmful runoff, and therefore should be prohibited. Based on our experience enforcing the regulations, we have not found superficial rust to be a problem with regard to either structural strength or sanitization. We are therefore making no changes based on this comment.
Housing Facilities: Surfaces; Cleaning--Section 3.1(c)(3)
We proposed in Sec. 3.1(c)(3) to require that hard surfaces that come in contact with dogs or cats be spot-cleaned daily and sanitized at least every 2 weeks. Proposed Sec. 3.10(b) also provided for various methods of sanitizing primary enclosures and food and water receptacles. Because these methods are effective in general for sanitization of hard surfaces that cats and dogs come in contact with, any of them could be used for the sanitization required by Sec. 3.1(c). We proposed that floors made of dirt, absorbent bedding, sand, gravel, grass, or other similar material would have to be raked or spot-cleaned with sufficient frequency to ensure all animals the freedom to avoid contact with excreta. This flooring material would have to be replaced if the raking and spot- cleaning were not sufficient to prevent or eliminate odors, pests, insects, or vermin infestation. We proposed that all other surfaces would have to be cleaned and sanitized when necessary to satisfy generally accepted professional and husbandry practices.
A small number of commenters stated that dogs or cats in large open runs may not need to have those areas cleaned daily. The regulations as proposed require only daily spot-cleaning of hard surfaces with which the dogs and cats come into contact. We consider such a requirement both practicable and necessary and are making no changes based on the comments.
One commenter opposed the use of floors such as dirt, sand, and gravel, stating that such materials cannot be adequately sanitized. We are making no changes based on these comments. While it is sometimes difficult to use standard sanitization procedures on such surfaces, it is relatively simple to replace specific areas as needed. Several commenters objected to the use of gravel surfaces on the grounds that the use of such material was inhumane. Section 3.1(a) of this final rule requires that housing facilities must protect the animals there from injury. In any cases where the use of gravel is shown to be causing injury, it is prohibited under Sec. 3.1(a).
Several commenters stated that sanitization should be required either daily or weekly. The provisions as proposed stated that sanitization must be carried out at least every two weeks, and more often if necessary to prevent an accumulation of dirt, debris, food waste, excreta, and other disease hazards. Based on our experience enforcing the regulations, we consider such provisions adequate for proper sanitization.
The regulations as proposed required cleaning to prevent any accumulation of excreta. Many commenters stated that it would be impossible to prevent all accumulation of excreta, and recommended that we delete the word "any" before the word "accumulation." We consider the commenters' point a valid one and are making the recommended change.
One commenter requested that we define "hard surfaces." We consider the term self-explanatory and are making no changes based on the comment.
Housing Facilities: Water and Electric Power--Section 3.1(d)
In the existing regulations, Sec. 3.1(b) specifies that reliable and adequate water and electric power must be made available "if required to comply with other provisions of this subpart." In our proposed rule, we set forth provisions concerning water and electric power in Sec. 3.1(d). We proposed there to eliminate the qualifying statement cited above, and to require that all facilities have reliable and adequate electric power and potable running water for the dogs' and cats' drinking needs, for cleaning, and for carrying out other husbandry requirements.
A small number of commenters supported the proposed provisions as written. Several commenters recommended that facilities be required to provide both hot and cold water. Several other commenters stated that the water available should be required to be potable only if used for drinking. We are making no changes to our proposal based on these comments. Because methods of sanitation exist that do not require hot water, we disagree that hot water is a necessity for adequate maintenance of a housing facility. However, we do consider it necessary to require that all water provided be potable, because it is difficult, if not impossible, to ensure that dogs and cats will not drink from puddles left from cleaning the facility.
Housing Facilities: Storage--Section 3.1(e)
We proposed in Sec. 3.1(e) to expand the regulations in existing Sec. 3.1(c) concerning proper storage of food and bedding supplies. The proposed provisions retained the requirements that food and bedding be stored so as to protect them from vermin infestation or contamination. Additionally, we proposed requirements to ensure further the quality of the food and bedding used by animals, and therefore of the area in which the animals are housed. We specified that open supplies of food and bedding would have to be stored in leakproof containers with tightly fitting lids to protect the supplies from spoilage and contamination. We proposed to require that the supplies be stored off the floor and away from the walls, to allow cleaning around and underneath them. We also proposed to require that food requiring refrigeration be stored accordingly, and that all food be stored so as to prevent contamination or deterioration of its nutritive value. Under the proposal, substances toxic to dogs and cats would not be allowed to be stored in food storage and preparation areas, but could be stored in cabinets in the animal areas.
A small number of commenters supported the proposed provisions as written. A small number of commenters stated that storage of food and bedding near walls should be permissible. We continue to believe that the provision restricting storage near walls is necessary to allow for cleaning and pest control and are making no changes to the proposal based on these comments.
Several commenters recommended that we require that food be stored in accordance with either manufacturer's recommendations, generally accepted practice, or human food service guidelines. We consider the intent of the commenters' recommendations to be met by the proposed requirement that all food be stored in a manner that prevents contamination and deterioration of its nutritive value.
A small number of commenters recommended that the regulations be less specific than proposed regarding where toxic substances may be stored, and require only that known toxic substances be stored in a manner so as to prevent accidental contamination of food products and contact with dogs and cats. We continue to believe that the well-being of the animals requires that no toxic substances be stored in food storage and preparation areas, and are retaining that provision in this final rule. Further, we continue to believe that because of the danger of toxicity to the animals housed, it is necessary to require that toxic substances stored in animal areas be kept in cabinets. We are therefore making no changes based on the comments.
One commenter stated that if toxic materials are stored in animal areas, it should be required that appropriate materials for cleaning up a spill be available. We do not consider such a requirement necessary. Provisions exist elsewhere in the regulations to ensure that the facility is maintained in such a way as to prevent injury to the animals. It will be incumbent upon the facility to ensure that they have the proper materials to comply with these provisions. In setting forth our proposal, our intent was to limit the toxic materials that may be housed in animal areas to those required for normal husbandry practices. We are therefore adding wording to Sec. 3.1(e) to clarify that intent.
One commenter stated that facilities should be allowed to adopt their own strategies for storing feed and chemicals, because the cost of providing additional storage space would be considerable. We consider the storage requirements proposed to be the minimum necessary, and to be in accordance with generally accepted husbandry and feed storage practices. We are therefore making no changes based on the comment.
Several commenters stated that instead of requiring that open supplies of food and bedding be stored in leakproof containers, the regulations should require that such supplies be stored in containers that will prevent contamination and spoilage. Based on our experience enforcing the regulations, we consider leakproof containers necessary to prevent contamination and spoilage, and are therefore making no changes based on these comments.
Housing Facilities: Drainage and Waste Disposal--Section 3.1(f)
In Sec. 3.1(f) as proposed, the requirement was retained that housing facilities provide for removal and disposal of animal and food wastes, bedding, dead animals, and debris, as provided in existing Sec. 3.1(d). We proposed to clarify this requirement to include all fluid wastes and to include a provision that arrangements must be made for regular and frequent collection, removal, and disposal of wastes, in a manner that minimizes contamination and disease risk. We also proposed to require that trash containers be leakproof and be tightly closed, and that no forms of animal waste, including dead animals, be kept in food and animal areas.
Requirements for drainage are contained in existing Secs. 3.2(e) and 3.3(d), under the sections concerning indoor facilities and outdoor facilities, respectively. Since all types of animal housing facilities, including our proposed categories of sheltered housing facilities and mobile or traveling housing facilities, must have some way of disposing of waste and liquids, we proposed to consolidate all drainage and waste disposal requirements in proposed Sec. 3.1(f).
Both existing Secs. 3.2(e) and 3.3(d) require that a suitable method of eliminating excess water be provided. We proposed to retain that requirement and expand it to pertain to sheltered and to mobile or traveling housing facilities as well. Existing Sec. 3.2(e) requires that any drains used be properly constructed and kept in good repair to guard against foul odors. Additionally, where closed drainage facilities are used, they must be equipped with traps and be installed so that they prevent the backflow of odors and the backup of sewage onto the floor. We proposed to retain these provisions and expand them for indoor facilities, and proposed that the expanded provisions would also apply to other types of facilities where such drainage is appropriate.
We also proposed to require that disposal and drainage systems minimize vermin and pest infestation, and disease hazards. As part of this safeguard, we proposed to require that any sump or settlement pond, or similar system for drainage and animal waste disposal, be located an adequate distance from the animal area of the housing facility. We also proposed to require that standing puddles of water in animal areas be promptly mopped up or drained so that the animals stay dry.
A small number of commenters specifically supported the provisions of proposed Sec. 3.1(f) as written. A large number of commenters interpreted our provisions regarding the prevention of odor and sewage as a requirement that closed drainage systems include backflow valves. Many commenters stated that installing such valves would be prohibitively expensive. The use of backflow valves was not specifically required in the proposed regulations. The provisions in question called for essentially the same standards as those already required under the existing regulations. We therefore do not expect facilities to experience significant practical or financial difficulties in meeting the standards.
A small number of commenters asserted that adequate provision to preclude direct contact of animals with sewage or other wastes was included in Sec. 3.10 of the proposal. We do not agree. Section 3.10 as proposed addresses cleaning, sanitization and housekeeping, but does not directly address drainage requirements.
One commenter recommended that we change the proposed requirement that animal waste and water be rapidly eliminated and that the animals be kept dry to read only that animal waste and water be adequately eliminated. We continue to believe that the wording of the proposal adequately conveys the intent of the proposed standard and are making no changes based on the comment.
A number of commenters recommended that we eliminate the proposed requirement that standing puddles of water in animal enclosures be drained or mopped up. These commenters stated that no evidence exists that dogs exercised in the rain suffer any deleterious effects. We do not consider pet animals being exercised in the rain by their owners to be parallel with animals housed within a facility. Because of the confined nature of such facilities, we consider the provision as proposed necessary to decrease the likelihood of contamination of the animals.
A number of commenters recommended that the regulations require that waste be removed from within the facility daily. One commenter recommended that such removal should occur twice daily. As proposed, removal of wastes must take place on a regular and frequent basis. We continue to believe that such a requirement will adequately protect the well-being of the animals, and are making no changes to that provision.
A number of commenters opposed the proposed requirement that trash containers have lids. We are making no changes based on these comments. We consider the covering of trash containers as necessary to control insects and odors. Under these regulations, the use of lids is required only in animal areas and food storage and preparation areas, not in office areas.
A number of commenters addressed the issue of sump ponds. A small number of commenters recommended that open sump ponds be prohibited. Several commenters recommended that the regulations include a specific minimum distance from research facilities that sump ponds may be located. As we stated in our proposal, based on our experience enforcing the regulations, we believe that sump ponds can be used without health risk if located an adequate distance from a facility. However, what constitutes an appropriate distance will often vary according to the size and configuration of the pond and the topography surrounding the facility. We believe this rule addresses these variables adequately and we are making no changes based on the comments.
A small number of commenters recommended that we add to our provisions regarding sump or settlement ponds the requirement that they be located far enough away from the facility to prevent the spread of diseases through the sewage system to the animal area. We are not aware of disease spread in such a manner having been a problem to date and are therefore making no changes based on these comments.
Several commenters stated that the wording we used to restrict storage of dead animals, animal parts, and animal waste was repetitive. We consider the wording used for the provision in question necessary for proper enforcement, and are making no changes based on the comments. One commenter stated that the prohibition of the storage of animal parts in food areas should not preclude storing canned food in refrigerators along with blood/serum samples. We are making no changes based on this comment. We believe that the danger of contamination of foodstuffs by animal parts can be significant, and that a general prohibition on commingling the two is necessary on a practical level for proper enforcement.
Housing Facilities: Washrooms and Sinks--Section 3.1(g)
In proposed Sec. 3.1(g), we proposed to retain the requirement in existing Sec. 3.1(e) that washing facilities be available to animal caretakers for their own cleanliness, and to include it in proposed Sec. 3.1(g). As proposed, facilities would be required to provide readily accessible washrooms, basins, sinks, or showers for animal caretakers. A small number of commenters recommended that showers be required. Conversely, several commenters expressed concern whether facilities with showers alone would meet the regulations. We are making no changes based on these comments. While we agree that showers can constitute adequate washing facilities, we do not consider them the only appropriate method of ensuring employee hygiene.
Temperature Requirements in Enclosed Facilities--Sections 3.2(a), 3.3(a), and 3.5(a)
We proposed that enclosed housing facilities--that is, indoor facilities, the sheltered portion of sheltered housing facilities, and mobile or traveling facilities--be sufficiently heated and cooled when necessary to protect the dogs and cats from temperature extremes and to provide for their health and well-being. We set forth the heating and cooling requirements for each of the above categories in Secs. 3.2(a), 3.3(a), and 3.5(a) respectively. We proposed to set forth ventilation requirements in Secs. 3.2(b), 3.3(b), and 3.5(b) respectively.
In establishing minimum temperatures for these facilities, the proposed regulations took into account whether a particular dog or cat housed there is acclimated to relatively low temperatures, and whether for some other reason, either because of breed, age, or condition, a dog or cat should not be subjected to certain low temperatures. In Sec. 3.2(a) of the existing regulations for indoor facilities, the minimum temperature allowed is 50 deg.F (10 deg.C) for all dogs and cats in those facilities that are not acclimated to lower temperatures. We proposed that in indoor, sheltered, and mobile or traveling housing facilities, the minimum temperature allowed continue to be 50 deg.F (10 deg.C) for dogs or cats not acclimated to lower temperatures. Because some dogs cannot be acclimated to lower temperatures, we also proposed to apply the 50 deg.F (10 deg.C) minimum to breeds of dogs or cats that cannot tolerate lower temperatures without stress and discomfort (e.g., short-haired breeds such as beagles, greyhounds, and Dobermans), and to dogs and cats that are sick, aged, young, or infirm. We proposed that exceptions to the 50 deg.F (10 deg.C) minimum could be made upon approval of the attending veterinarian, and that the minimum temperature for all other dogs and cats would be 35 deg.F (1.7 deg.C).
In the existing regulations, there is no maximum temperature specified for indoor housing facilities, although auxiliary ventilation is required when the temperature rises to or above 85 deg.F (29.5 deg.C). In the proposed rule, we established a maximum temperature of 95 deg.F (35 deg.C) for indoor facilities, mobile or traveling facilities, and the sheltered part of sheltered housing facilities, when those facilities contain dogs or cats. For each of those categories of shelters, we proposed that auxiliary ventilation, such as fans or air conditioning, would have to be used when the temperature rises to or above 85 deg.F (29.5 deg.C).
We received a large number of comments with regard to the temperature in indoor, sheltered, and mobile and traveling housing facilities. A number of commenters recommended specific temperature ranges that were more stringent than those included in our proposal. A number of commenters stated either that our proposed temperature ranges were too narrow, or that they did not leave enough latitude for professional judgment on the part of the attending veterinarian in the case of individual animals or breeds. We continue to believe that the well-being of dogs and cats housed in enclosed facilities requires that parameters be established for hot and cold temperatures. Although the regulations as proposed provide the attending veterinarian some latitude in deciding whether unacclimated dogs and cats may be exposed to temperatures lower than an otherwise specified limit, we do not believe that the needs of the animals housed vary so widely as to warrant removing all temperature limits.
A number of commenters stated that the 35 deg.F and 95 deg.F limits we proposed were too lenient. On the other hand, a large number of commenters stated that the limits we proposed did not adequately take into account acclimated animals that can tolerate temperatures outside those limits. Upon review of the comments, we consider both viewpoints to have some merit. While the limits we proposed may become intolerable to certain animals at the extremes, we agree that animals can become acclimated to temperatures outside those limits. Therefore, in this final rule, we are establishing general temperature limits more stringent than those proposed, while at the same time allowing flexibility to accommodate animals that can tolerate temperatures outside those limits. We are providing in this final rule that the ambient temperature in the enclosed facilities must not fall below 45 deg.F (7.2 deg.C) for more than 4 consecutive hours when dogs or cats are present, and must not rise above 85 deg.F (29.5 deg.C) for more than 4 consecutive hours when dogs or cats are present.
A small number of commenters recommended that the regulations require that alternative surfaces that allow the dogs and cats to avoid surfaces such as concrete or metal be made available to every animal when the temperature falls below 45 deg.F (7.2 deg.C), and to sick, aged, infirm, or very small animals at other times. Upon review of the comments, we agree that in order for certain dogs and cats to tolerate cold temperatures, they must be able to conserve their body heat. To allow for such conservation of body heat, we are including in this final rule the requirement that enclosed housing facilities provide dry bedding, solid resting boards, or other methods of conserving body heat when temperatures are below 50 deg.F (10 deg.C).
Many commenters stated that short-haired breeds should not be limited to a 50 deg.F (10 deg.C) minimum temperature, because some short-haired breeds are what the commenters termed "winter hardy." We are making no changes based on these comments. Although we consider 50 deg.F a necessary minimum for the well-being of most short-haired breeds, the regulations as proposed provided the attending veterinarian the professional discretion to make exceptions where appropriate. A small number of commenters objected to the allowance of such exceptions. We continue to believe that the professional education and experience of the attending veterinarian enables him or her to make a professional judgment based on the condition of the animal and the circumstances involved, and that such flexibility is necessary to accommodate differences in individual animals and situations.
One commenter stated that setting minimum and maximum temperatures alone is not sound, and that standards should be written that take into account temperatures, humidity, air velocity, and acclimation requirements for breeds and species. To the best of our knowledge, the comprehensive information described by the commenter does not exist. Based on the information available to us, and on our experience enforcing the regulations, we consider the temperature limits we have set as minimum standards for the health and well-being of the animals in question.
Several commenters, addressing the temperature requirements for sheltered housing facilities, questioned whether the outdoor portion of sheltered housing facilities must be closed off when the temperature falls outside the allowable range for the enclosed portion of the facility. Several commenters also requested that the regulations clarify that sheltered housing facilities are not required to control the temperature of the outside portion of those facilities. We believe that common sense dictates that the outdoor portion of sheltered housing facilities cannot be heated, and that no further clarification is necessary in the regulations. In a sheltered facility, the enclosed area must be available to the animals at all times. There is therefore no reason to restrict the animals from exiting to the outdoor portion if they choose.
Ventilation Requirements in Housing Facilities--Sections 3.2(b), 3.3(b), and 3.5(b)
The requirements for ventilation of indoor housing facilities that are set forth in Sec. 3.2(b) of the existing regulations were retained in the proposal, and were extended to apply to all sheltered portions of sheltered, and mobile or traveling housing facilities to provide for the health and well-being of dogs and cats. Based on our inspections of dealer, exhibitor, and research facilities, we proposed to add (1) That ventilation must also be provided to minimize odors, drafts, ammonia levels, and moisture condensation in these housing facilities; (2) that ventilation in mobile or traveling facilities must minimize exhaust fumes; and (3) that in indoor housing facilities and the sheltered part of sheltered housing facilities, the relative humidity must be maintained at a level that ensures the health and well-being of the dogs or cats housed in the facility, in accordance with the directions of the attending veterinarian and generally accepted professional and husbandry practices.
A small number of commenters specifically supported the ventilation requirements in the proposed rule. A small number of commenters recommended that it be required that the relative humidity in indoor facilities be maintained between 30 and 70 percent. Others recommended in general that specific ventilation standards be established to eliminate disagreements between inspectors and facilities. We are making no changes based on these comments. The effect on animals of a particular level of humidity depends to a great degree on other factors, such as temperature and ventilation. We therefore consider it appropriate as proposed to allow professional discretion regarding exact humidity levels.
A small number of commenters stated that it is unnecessary to require as proposed that auxiliary ventilation be used at temperatures equaling or exceeding 85 deg.F (29.5 deg.C), because the regulations as proposed require in general that facilities be sufficiently ventilated to provide for dogs' and cats' health and well-being. While we agree that the requirement for auxiliary ventilation at higher temperatures falls under the general requirement for adequate ventilation, we continue to believe that it serves a specific and necessary purpose. Based on our experience enforcing the regulations, achieving adequate ventilation at moderate temperatures can be accomplished through various means, such as either natural or mechanical ventilation. However, at higher temperatures, auxiliary ventilation becomes necessary on a uniform basis in ensuring the health and well-being of the animals. We are therefore making no changes based on the comments.
A number of commenters opposed the requirement for auxiliary ventilation at 85 deg.F in cases where animals are acclimated to such conditions. We are making no changes based on these comments. Because an animal is acclimated to high temperatures under one set of conditions does not ensure that it can tolerate those same temperatures under all conditions. It is the combination of temperature, humidity, and ventilation, along with whether an area is open or enclosed, that determines whether conditions are tolerable. Because the effect of a high temperature is heightened in a confined space, we consider it necessary that auxiliary ventilation be provided for all dogs and cats housed in enclosed areas when the temperature reaches or exceeds 85 deg.F.
A small number of commenters stated that the regulations should require that auxiliary ventilation be used in mobile or traveling housing facilities when the ambient temperature reaches 75 deg.F. The commenters' recommendations were not supported by additional data as to why the change from our proposal would be necessary, and we are making no changes based on this comment.
One commenter expressed concern that determining what constitutes excessive odor will involve a subjective evaluation. The requirement that odors be minimized is included in the existing regulations. While we agree that it does not lend itself to precise measurement, we consider the word "minimize" to be sufficiently measurable for enforcement purposes.
Lighting Requirements in Housing Facilities--Sections 3.2(c), 3.3(c), and 3.5(c)
In the proposed regulations, we retained the requirement in Sec. 3.2(c) of the existing regulations that indoor housing facilities have ample light to permit routine cleaning and inspection, and proposed also that it must allow observation of the dogs and cats. We proposed to apply these requirements to all of the enclosed housing facilities included in the proposed regulations. We also proposed to require in each case that either natural or artificial light be provided according to a regular diurnal lighting cycle, and that sufficient light be provided to aid in maintaining good housekeeping practices, adequate cleaning, adequate inspection of animals, and for the well-being of the animals. Also, in our proposal, we retained the requirement in the existing regulations for indoor facilities that primary enclosures be placed so as not to expose the animals in them to excessive light, and we proposed to extend that requirement to sheltered enclosures.
A small number of commenters specifically supported the lighting requirements as proposed. Several commenters responded to the statement we originally made in the supplementary information of our original proposal that an example of excessive lighting might involve an animal housed in the top cage of a stack of cages near a light fixture. The commenters stated that there is no evidence that dogs and cats are harmed by the level of light generated by artificial sources when housed in top cages. We recognize that not all animals housed in top cages are exposed to excessive light, and have included no standards in the regulations specifically addressing such housing. As we explained in our revised proposal, and as we continue to believe, the example we provided involves just one of a variety of situations that could constitute excessive light.
A number of commenters objected to the proposed requirement for lighting on a regular diurnal cycle, and recommended instead that the regulations require a specific number of hours of light or darkness each day. Upon review of the comments, we continue to believe that it would not be beneficial in all cases to establish one specific timetable for lighting. Such a specific timetable might not be necessary or warranted in all cases, and might not coincide with normal outdoor lighting cycles at a particular time of year. The wording as proposed is designed to allow for professional discretion regarding lighting appropriate to varying situations.
A number of commenters objected to the provision in our proposal that light in enclosed housing facilities be uniformly diffused. One commenter stated that the uniform diffusion of light in a facility is technically impossible. The requirement in our proposal for the uniform diffusion of light is very similar to the requirement in the existing regulations for "uniformly distributed illumination." Our intent in retaining the requirement for uniform lighting was to allow for proper cleaning, observation of animals, and inspection, without the need for an additional light source, such as a flashlight. We consider this standard to be both necessary and attainable.
One commenter stated that the lighting standards were only minimal. As we discussed in our revised proposal, it is our purpose throughout the regulations to establish minimum standards for the health and well-being of regulated animals. Although we encourage practices that exceed the minimum, we consider the standards in this final rule adequate to meet their purpose.
In our proposal, the lighting requirements for mobile or traveling housing facilities did not contain a prohibition of excessive lighting. One commenter stated that such a prohibition should be included. Because of the nature of mobile and traveling housing facilities, and the electrical and lighting systems present in such facilities, we have not found excessive lighting there to be a problem. We are therefore making no changes based on the comment.
Specific Provisions for Indoor Housing Facilities--Section 3.2(d)
Section 3.2(d) of the existing regulations, regarding the interior surfaces of indoor housing facilities, requires that those surfaces be substantially impervious to moisture and readily sanitized. In Sec. 3.2(d) of the proposed regulations, we retained the requirement that all surfaces be impervious to moisture, but made an exception in the case of ceilings that are replaceable. An example of this would be a suspended ceiling with replaceable panels. The requirements we proposed concerning interior surfaces are more stringent for indoor housing facilities than for any other type of facility. Only for indoor facilities, for example, did we propose that ceilings have to be either impervious to moisture or replaceable. This is because indoor facilities generally operate on one ventilation system, and any disease organisms or excessive odors that occur in the facility might spread throughout the facility, requiring a thorough cleaning or replacement of all interior surfaces.
A number of commenters specifically supported the proposed provisions as written. Several commenters stated that ceilings should always be impervious to moisture, and recommended that we delete the provision that they may be replaceable. We are making no changes based on this comment. In many cases, replacing a ceiling would be more effective in minimizing disease risk than cleaning it.
A small number of commenters recommended that the proposed provisions regarding ceilings be changed to require that the ceiling be kept clean and dry. We consider the proposed wording adequate to convey this intent and are making no changes based on these comments.
One commenter stated that the requirement for impervious or replaceable ceilings discriminates against research facilities, because ceilings are not addressed with regard to mobile, outdoor, and sheltered facilities. The requirement for impervious or replaceable ceilings has nothing to do with the purpose of a facility. As we explained in our proposal, we consider the more stringent requirement necessary for indoor facilities because indoor facilities generally operate on one ventilation system, and any disease organisms or excessive odors that occur in the facility might spread throughout the facility, requiring a thorough cleaning or replacement of all interior surfaces.
A number of commenters objected to our proposed requirement that certain areas of indoor facilities be impervious to moisture, and recommended instead that the proposal call for surfaces that are either moisture retardant or repellant. Some of these commenters stated that surfaces impervious to moisture might not allow for secure footing. We are making no changes based on these comments. We do not agree that because a surface is impervious to moisture implies that it causes insecure footing. We also do not consider moisture-retardant surfaces adequate to achieve the necessary end, which is prevention of the absorption of fluids and wastes. The intent of the provision was to facilitate cleaning and sanitation and to decrease odors and disease hazards. We continue to consider impervious surfaces in indoor facilities necessary to achieve these ends.
Specific Provisions for Sheltered Housing Facilities--Sections 3.3 (d) and (e)
In proposed Sec. 3.3(d) regarding sheltered housing facilities, we set forth the requirement that dogs and cats be provided with adequate shelter and protection from the elements to protect their health and well-being.
In order to maintain sanitary conditions in sheltered housing facilities, we proposed to establish the following requirements in Sec. 3.3(e). Under our proposal, the following areas would have to be impervious to moisture: (I) Indoor floor areas in contact with the animals; (2) outdoor floor areas not exposed to the direct sun or made of a hard material such as wire, wood, metal, or concrete, in contact with the animals; and (3) all walls, boxes, houses, dens, and other surfaces in contact with the animals. We proposed that outside floor areas in contact with the animals and exposed to the direct sun could consist of compacted earth, absorbent bedding, sand, gravel, or grass.
A small number of commenters specifically supported the provisions regarding sheltered housing facilities as written. Several commenters, in referring to shelter at sheltered housing facilities, recommended specific protection from heat for traditional dog houses. In general, we do not expect the use of traditional dog houses in sheltered housing facilities and are making no changes based on these comments.
One commenter requested that we define "adequate shelter." We consider the meaning of "adequate shelter" to be clear in Sec. 3.3 as proposed and are making no changes based on this comment.
A small number of commenters recommended that we reword our proposed requirements regarding shelter to make it clear that the sheltered housing facility must be large enough to provide all the animals present with shelter from the elements at the same time. We agree that it would be beneficial for the animals involved to clarify that shelter must accommodate all animals comfortably. We are therefore adding wording to Sec. 3.3(d) as proposed to require that the shelter structures must be large enough to allow each animal to sit, stand, and lie in a normal manner and to turn about freely.
One commenter stated that the provisions regarding exposure to direct sun should include a specific duration of such exposure. The intent of those provisions was that the floor areas in question must be exposed to sunlight at some time during the day. Based on that intent, we do not consider it necessary to specify a duration of sunlight.
One commenter stated that outdoor floor areas should not be restricted solely to those materials listed in Sec. 3.3(e)(2) (compacted earth, absorbent bedding, sand, gravel, or grass). The proposed regulations as written do not restrict outside areas to the surfaces listed in Sec. 3.3(e)(2). Examples of alternative surfaces are provided in Sec. 3.3(e)(1)(ii).
Specific Provisions for Outdoor Housing Facilities--Section 3.4
The intent of Sec. 3.3 of the existing regulations is to provide adequate standards for the care of animals housed outdoors. However, our inspections of dealers' and exhibitors' facilities in climates with temperature extremes have indicated that some licensees are not meeting what we believe should be minimum standards for the treatment of dogs and cats. Specifically, we consider it necessary to make the regulations more stringent regarding the types of dogs and cats that can be kept outdoors, and regarding what shelter is necessary for dogs and cats kept outdoors. Therefore, we proposed to revise the existing requirements for outdoor facilities, to make them more clearly defined and more stringent.
Because outdoor facilities cannot be temperature-controlled, it is necessary to judge a dog's or cat's suitability for outdoor housing on an individual basis. We set forth provisions in proposed Sec. 3.4(a)(1) that a dog or cat could not be kept in an outdoor facility, unless specifically approved by the attending veterinarian, if (1) it is not acclimated to the temperatures prevalent in the area or region where the facility is located; (2) it is of a breed that cannot tolerate the prevalent temperatures of the area without stress or discomfort (such as short-haired breeds in cold climates); or (3) it is aged, young, sick or infirm. We recognize that in some situations, particularly in the case of dogs or cats obtained from pounds, it will not be known whether an animal has been acclimated to prevailing temperatures. Therefore, in proposed Sec. 3.4(a)(2), we provided that if a dog's or cat's acclimation status is unknown, it must not be kept in an outdoor facility when the ambient temperature is less than 35 deg.F (1.7 deg.C).
With regard to the type of shelter required for dogs and cats housed outdoors, we believe that the existing regulations should be expanded to specify what is necessary for better and more humane treatment of the dogs and cats. In essence, the existing regulations require that dogs and cats be provided with sufficient shade to protect them from the direct rays of the sun, shelter to keep them dry during rain or snow, and shelter when the atmospheric temperature falls below 50 deg.F (10 deg.C). Additionally, bedding or some other protection is required when the ambient temperature falls below that to which the dog or cat is acclimated.
In Sec. 3.4(b) of the proposed rule, we set forth the requirement that all outdoor facilities housing dogs or cats include one or more shelter structures that are accessible to all animals in the facility, and that are large enough to allow all animals in the structure to sit, stand, and lie in a normal manner, and to turn about freely. We proposed in Sec. 3.4(b) that the shelter structure would have to: (1) Provide adequate shelter and protection from the cold and heat; (2) be protected from the direct rays of the sun and the direct effect of wind, rain, or snow; (3) have a wind break and a rain break at its entrance; (4) contain clean, dry, bedding material; and (5) include a roof, four sides, and a floor. We also proposed in Sec. 3.4(b) that in addition to the shelter structure, there would have to be one or more separate outside areas of shade provided, large enough to contain all the animals at one time and to protect them from the direct rays of the sun.
In proposed Sec. 3.4(c), we set forth the requirement that all building surfaces that are in contact with dogs or cats in outdoor housing facilities be impervious to moisture. We specified that metal barrels, cars, refrigerators or freezers, and the like would not be permitted as shelter structures, and that the floors of outdoor housing facilities could be of compacted earth, absorbent bedding, sand, gravel, or grass, but would have to be kept clean.
A small number of commenters specifically supported the provisions regarding outdoor housing facilities as written.
A small number of commenters objected to the 35 deg.F minimum for dogs and cats at outdoor housing facilities, when the acclimation status of those animals is unknown. One of these commenters stated that the proposed 35 deg.F minimum was inconsistent with the 50 deg.F proposed minimum in indoor and sheltered housing facilities for dogs not acclimated to lower temperatures. We agree that temperatures below 50 deg.F can be just as hazardous to unacclimated animals at outdoor facilities as at indoor and sheltered housing facilities, and are therefore providing in this final rule that dogs and cats whose acclimation status is unknown must not be kept in outdoor facilities when the ambient temperature is less than 50 deg.F (10 deg.C).
A small number of commenters stated that the minimum temperature for dogs and cats of unknown acclimation status should be removed, and responsibility for such decisions left to the attending veterinarian. We do not agree that the attending veterinarian can make a valid decision regarding an animal's tolerance without knowing its acclimation status and are making no changes based on these comments.
Many commenters recommended that we delete short-haired breeds in cold climates as an example of dogs or cats that must not be housed in outdoor facilities. We are making no changes based on these comments. Most short-haired breeds cannot tolerate cold temperatures. In those cases where individual animals or breeds can tolerate cold temperatures, the regulations as proposed allow for professional discretion on the part of the attending veterinarian.
A small number of commenters objected to the proposed regulations which allow the attending veterinarian to grant exceptions to the general prohibition on housing certain dogs and cats outside. We continue to believe that differences in animals and varying situations make it necessary to allow for professional judgment in certain cases. We also continue to believe that the attending veterinarian is the individual best qualified to exercise this judgment.
A small number of commenters stated that specific standards for what constitutes "acclimation" should be included in the regulations. We consider the term "acclimation" to be adequately defined by normal usage, and do not consider it necessary to define the term further. One commenter recommended that we delineate more specifically which dogs and cats may not be housed outdoors. We consider the provisions as proposed to be clear as written and are making no changes based on this comment. One commenter stated that the terms "sick," "infirm," "aged," and "young" should be defined. We expect the attending veterinarian to exercise professional judgment regarding these terms, and do not agree that specific definitions beyond those which are commonly understood are necessary or desirable.
One commenter stated that the wind chill factor must be considered in the outdoor housing of dogs and cats. We agree, and consider this factor to be addressed in Sec. 3.4(b) as proposed, regarding shelter from the elements.
A number of commenters addressed the provisions in proposed Sec. 3.4(b), regarding shelter from the elements at outdoor housing facilities. Several commenters recommended that a maximum of six dogs be allowed per shelter. We do not consider such a limit necessary. Proposed Sec. 3.6 of the regulations allows for a maximum of 12 nonconditioned dogs per primary enclosure. We see no reason to set a limit on conditioned animals, provided the space and compatibility requirements otherwise required by the regulations are met.
Several commenters requested definitions of "wind break" and "rain break." We believe these terms are self-explanatory and need no further clarification.
A small number of commenters stated that the shelters at outdoor housing facilities should be required to be maintained at indoor temperature ranges. We do not consider such a requirement practical; nor do we consider it necessary in light of the other specific requirements designed to ensure the health and well-being of animals kept at outdoor housing facilities.
A small number of commenters addressed the issue of bedding material at outdoor housing facilities, as required by proposed Sec. 3.4(b)(4). Approximately half of these commenters opposed the requirement for bedding, stating either that group-housed dogs create their own heat, or that bedding materials can serve as fomites for potential disease problems. Conversely, one commenter stated that clean, dry bedding should be required at all times to prevent sores. Another commenter requested that the regulations specify the amount of additional bedding needed at cold temperatures, so that compliance can be verified. We do not agree that the requirement for bedding should be eliminated. We do not consider it advisable to depend on group-housing of dogs to provide adequate warmth at outdoor facilities. Nor do we believe that potential disease hazards from bedding that is improperly cared for should preclude the requirement for bedding material. We also do not consider it practical or necessary to specify exactly how much bedding should be provided. Such a decision should be based on professional judgment regarding species, breed, and prevailing conditions. With regard to requiring bedding to prevent sores, Sec. 3.1(a) of the standards requires that housing facilities protect animals from injury. If the animals in a facility are suffering from sores, then the facility must take measures to come back into compliance with the regulations. Although the use of bedding is one possible solution, we do not consider it necessary to impose a uniform requirement for bedding in all cases.
A number of commenters addressed the provisions in proposed Sec. 3.4(c), regarding the construction of outdoor housing facilities. A small number of commenters supported the proposed provisions as written. A number of commenters took issue with our proposed requirement that floor surfaces in outdoor housing facilities--if made of compacted earth, sand, gravel, or grass--be replaced if there are any prevalent odors, diseases, insects, pests, or vermin. The commenters expressed the opinion that such materials cannot be replaced. We disagree, and consider it both practical and feasible to replace any of the materials listed.
Primary Enclosures--Section 3.6
In proposed Sec. 3.6, we proposed to amend existing Sec. 3.4, "Primary enclosures." The existing section provides general requirements for construction and maintenance of primary enclosures, uniform space requirements for each dog or cat housed in a primary enclosure, and provisions regarding litter and resting surfaces for cats and the tethering of dogs on chains. We proposed to expand the existing general requirements, to add some new requirements, and to clarify the existing requirements in accordance with the intent of the amendments to the Act.
A small number of commenters opposed in general the proposed provisions regarding primary enclosures. A number of commenters recommended that the regulations require that primary enclosures comply with all applicable Federal, State, and local laws and regulations. We disagree. As noted above, our mandate under the Act may not necessarily be the same as those of other Federal, State, and local laws. We do not consider it necessary to attempt to require compliance with other laws to establish minimum standards for primary enclosures.
Primary Enclosures: General Requirements--Section 3.6(a)
The provisions we set forth in proposed Sec. 3.6 regarding primary enclosures contained requirements that all primary enclosures meet certain minimum standards to help ensure the safety and well-being of dogs and cats. A primary enclosure is defined in Part 1 of the regulations as "any structure or device used to restrict an animal or animals to a limited amount of space, such as a room, pen, run, cage, compartment, pool, hutch, or tether." Included among the primary enclosures subject to the proposed regulations are those used by circuses, carnivals, traveling zoos, educational exhibits, and other traveling animal acts and shows. In Sec. 3.6(a) we proposed to continue to require that primary enclosures be structurally sound and maintained in good repair to protect the animals from injury, to contain them, and to keep other animals out. We also proposed to require that the primary enclosures keep unauthorized humans out. We proposed to continue to require that the primary enclosures enable the animals to remain dry and clean; that they provide the animals with convenient access to food and water; that they provide sufficient space for the dogs and cats to have normal freedom of movement; and that their floors be constructed in a manner that protects the animals from injury. With regard to this last requirement, we proposed to specify that if the floors of primary enclosures are of mesh or slatted construction, they must not allow the animals' feet to pass through any openings in the floor.
We proposed to add requirements that the primary enclosures be constructed without sharp points or edges, and that they provide sufficient shade to the animals in the enclosures and protect them from temperature extremes and other weather conditions that might be uncomfortable or hazardous to the animals. We also proposed to require that the primary enclosures be easily cleaned and sanitized, or be replaceable when worn or soiled.
A number of commenters specifically supported the provisions in proposed Sec. 3.6(a) as written.
Section 3.6(a)(2)(iv) of our proposal stated that primary enclosures must be constructed so as to keep other animals and unauthorized humans from entering the enclosures. A number of commenters objected to this provision, stating that such security is unnecessary for the primary enclosure because of similar security measures required elsewhere in the regulations for the housing facility itself. We disagree with the assertion of the commenters. Even assuming that no unwanted animals would ever enter the facility from the outside, there is still the risk that animals within the facility might escape from their enclosures and pose a risk to confined animals, unless the primary enclosures guard against such risk. We are, however, deleting the requirement that unauthorized humans be kept from entering the primary enclosures, for the reasons set forth in this supplementary information under the heading, "Housing Facilities: Structure; Construction--Sec. 3.1(a)."
Several commenters stated that the provisions in proposed Secs. 3.6(a)(2)(vi) and (a)(2)(vii), regarding protection from weather conditions and the need for shade, respectively, were unnecessary, because shelter and protection from the sun are already addressed elsewhere in the regulations with regard to housing facilities in general. Because housing facilities and primary enclosures are not always the same or equivalent, the provisions as proposed are necessary in both places in the regulations. We are therefore making no changes based on these comments. One commenter objected to the requirement that primary enclosures provide shelter because, according to the commenter, although many types of primary enclosures provide adequate protection when used in an enclosed housing facility, they would not meet the criterion of supplying sufficient shelter in areas not otherwise sheltered by the facility. We are making no changes based on this comment. The regulations do not require that a primary enclosure be able to provide adequate shelter under circumstances that do not exist, only that they properly protect the animals in them in any given situation.
Several commenters recommended that Sec. 3.6(a)(2)(vi) make it clear that shelter and protection from the elements must be accessible to all animals in an enclosure at the same time, and that similar clarification be added in Sec. 3.6(a)(2)(viii) with regard to access to food and water We agree that such a change will better convey the intent of the regulations and are so amending this final rule.
A number of commenters addressed the provisions in proposed Sec. 3.6(a)(2)(x), requiring that, if primary enclosures have floors that are of mesh or slatted construction, they do not allow the dogs' and cats' feet to pass through any openings in the floor. Some commenters opposed mesh flooring of any sort. A small number of commenters expressed the opinion that flooring should always be small mesh. Others were divided as to whether mesh should be allowed that is large enough to permit passage of feces, even though such flooring would probably also allow passage of a dog's or cat's foot. Several commenters stated that floor mesh should be large enough to allow the animals' feet to pass freely back and forth. A small number of commenters stated that flooring designs and materials should be researched individually to suit the situation and the species involved.
We do not consider it practical or necessary to prohibit the use of mesh floors. Many mesh designs can be used without detriment to the animals involved. With regard to the size of openings in the floor, the intent of the Act is to provide for the health and well- being of the animals. Floors that can injure the animals by allowing their legs to pass through do not comply with the intent of the Act, whether or not they prohibit the passage of feces. We do not consider ease of cleaning to be a higher priority than the safety of the animals. We are therefore making no changes based on these comments.
One commenter stated that, because wire or slatted mesh flooring is uncomfortable and may be injurious to the animals enclosed, the regulations should require that solid resting surfaces be provided for both dogs and cats. We agree that certain types of flooring do not allow any relief for the animals enclosed. We are therefore adding a provision to Sec. 3.6(a)(2)(x) of this final rule to require the following: If the floor of a primary enclosure is constructed of wire, a solid resting surface or surfaces that, in the aggregate, are large enough to hold all the occupants of the primary enclosure at the same time comfortably, must be provided. Section 3.6(a)(2)(xi) of our proposal states that primary enclosures must be constructed so as to provide sufficient space to allow each animal to turn about freely, to stand, sit, and lie in a comfortable, normal position, and to walk in a normal manner. A small number of commenters recommended that the wording be changed to read "provide space that is adequate and permits freedom of movement and normal postural adjustments." We believe that the wording we proposed conveys the intent of the provision adequately and we are making no changes based on these comments. One commenter requested that we define and justify the phrase "to walk in a normal manner." We believe that the meaning of the phrase is self- evident and we are making no changes based on these comments.
Additional Primary Enclosure Requirements for Cats--Section 3.6(b)
We proposed to change the space requirements for cats. In general, the proposed regulations based how much space a cat should have on the animal's weight, and whether it is a nursing mother. The space requirements in Secs. 3.4 (b)(1) and (b)(3) of the existing regulations are uniform for all cats, regardless of size, and require that each cat be given a minimum of 2.5 ft2, with room to turn about freely, and to easily stand, sit, and lie in a comfortable normal position. We consider it necessary, based on our inspections of research facilities, to increase the existing minimum space requirements for all cats. Additionally, because the weight of a cat is a good indicator of its overall size, the floor space requirements should distinguish between cats of different weights. Our proposed standards would provide cats with the space we believe is necessary, and at the same time make our regulations correspond more closely to the NIH Guide. We proposed in Sec. 3.6(b)(1)(ii) (redesignated as Sec. 3.6(b)(1)(ii)(B) in this final rule) to require that weaned cats weighing 8.8 lbs (4 kg) or less be provided with at least 3.0 ft2 (0.28 m2) of floor space. We proposed in Sec. 3.6(b)(1)(iii) (redesignated as Sec. 3.6(b)(1)(ii)(C) in this final rule) that cats weighing over 8.8 lbs (4 kg) be provided with a minimum of 4.0 ft2 (0.37m2) of floor space. Additionally, we proposed to require that each queen with nursing kittens be provided with an additional amount of floor space, based on her breed and behavioral characteristics, and in accordance with generally accepted husbandry practices as determined by the attending veterinarian. We proposed that if the additional amount of floor space for each nursing kitten is equivalent to less than 5 percent of the minimum requirements for the queen, such housing must be approved by the Committee in the case of a research facility, and by the Administrator in the case of dealers and exhibitors. We proposed to provide that the minimum floor space required would be exclusive of any food or water pans, but that the litter pan may be considered part of the floor space if properly cleaned and sanitized. We proposed in Sec. 3.6(b)(1)(i) (redesignated as Sec. 3.6(b)(1)(ii)(A) in this final rule) that the height of the primary enclosure for cats would have to be at least 24 inches (60.96 cm).
A large number of commenters addressed the provisions in proposed Sec. 3.6(b)(1) regarding minimum space requirements for cats. A number of commenters specifically supported increased space requirements for cats. A small number of commenters recommended retaining the existing space requirements for cats, either in general or based on the judgment of the attending veterinarian. A large number of commenters recommended doubling the minimum cage size for cats. A small number of commenters stated that all cats, regardless of weight, should be provided with at least 4 square feet of cage space. With regard to the height of primary enclosures, one commenter recommended that the minimum requirement provide only that the interior height must allow the animals to stand and sit without touching the top. We are making no changes to the regulations based on the comments regarding the size of primary enclosures for cats. In developing new proposed space standards, we have consulted extensively with HHS, as statutorily mandated. The space requirements we proposed are consistent with other Federal guidelines, and we consider them necessary and adequate for the well-being of the cats. We do not agree that all cats need to be provided with the same amount of space. It is unreasonable to require that a cat weighing 1 lb. be provided the same amount of space as a cat weighing 10 lbs.
A number of commenters requested that justification be provided for the provision in proposed Sec. 3.6(b)(1)(v) (redesignated as Sec. 3.6(b)(1)(iv) in this final rule) that food and water pans would not be counted as required floor space. We believe it is obvious that requiring animals to walk or rest in their food and water receptacles in order to achieve adequate space would encourage sanitation and health problems.
A number of commenters requested that existing primary enclosures that would meet the proposed space requirements if the space occupied by food and water bowls is counted, be permitted usage until needing replacement for normal wear and tear. As discussed in the preceding paragraph, it is not humane to require cats to use their food and water bowls as part of their minimum floor space, and we do not agree with the commenters' recommendation.
A number of commenters addressed the proposed requirement for increased space for nursing queens. A small number of commenters opposed allowing such additional space. Other commenters recommended that the standard additional space per kitten be 10 percent, rather than 5 percent as proposed, or that the regulations provide specific requirements for neonatal floor space, rather than percentage requirements. We are making no changes based on these comments. The general minimum space requirements for cats that we proposed were found to be necessary for each animal. We consider it self-evident that additional animals in an enclosure will occasion the need for additional space. We disagree, however, that an additional 10 percent is necessary for each kitten, especially in view of the fact that this final rule will increase the minimum space requirements for adult cats. We also disagree that specific uniform requirements for nursing queens are appropriate. The space necessary for the queen herself will be determined by her weight. We consider it reasonable to base the additional space necessary for nursing kittens on the number of kittens present.
Several commenters recommended that the requirement for additional space for nursing queens not begin until the kittens are 3 weeks old. We disagree. Not only is the additional space necessary from the kittens' birth, but adopting the commenters' recommendation would often result in an unnecessary movement of the queen and kittens.
One commenter stated that the provisions regarding increased space for nursing kittens was unenforceable, because breed and behavioral characteristics do not provide a useful determinant. The commenter stated further that "accepted husbandry practices" are the very practices Congress wishes to change. We disagree with the commenter. We consider the consideration of breed and behavioral characteristics to be a legitimate method of assessing the needs of individual animals. As noted above, 5 percent additional space will be the norm. Departures must be approved by the attending veterinarian or the Administrator. Further, we disagree that "accepted husbandry practices" are generally inadequate or harmful to animals. In the 1985 amendments to the Act, Congress specifically mandated only that the Department establish regulations to promote exercise in dogs and to provide an environment that promotes the psychological well-being of nonhuman primates. Requiring additional space for nursing kittens, and also for nursing puppies, is a change that the Department feels is necessary in the interest of promoting the general welfare of these animals. We consider the new provisions an improvement over the existing regulations, and disagree that they do not meet Congressional intent.
One commenter stated that nursing queens should be provided a nest box. We do not agree that a nest box is necessary for individually housed queens, and the regulations prohibit the group housing of queens with litters, except in breeding colonies. Based on our experience enforcing the regulations, there has been no indication that nest boxes are needed.
A small number of comm