Chapter 2. Laws, Regulations, and Policies Affecting the Use of Laboratory Animals Flashcards
28-Hour Law (1873)
First federal legislation in the US to protect animals. Required that farm animals be provided food, water, and rest at least once every 28 hours during transit.
Laboratory Animal Welfare Act (PL-89-544) (1966)
First federal legislation to protect animals used for research. Required licensing of dealers that bought or sold dogs or cats for research as well as registration of research facilities that used dogs or cats. Mandated minimum animal care standards for dogs and cats before and after use in research - did NOT apply to when being used for research. Authorized the USDA to develop and enforce these regulations. USDA subsequently included standards for NHPs, rabbits, guinea pigs, and hamsters. Facilities that used dogs or cats were required to comply with standards for all species; facilities that did not have dogs or cats were not required to comply with any standards.
Animal Welfare Act (PL-91-579) (1970)
Amendment of Laboratory Animal Welfare Act. Broadened scope of protection to include animals used for teaching, exhibitions, and the wholesale pet industry. Applied to animal care during the course of research. Did not allow the Secretary of Agriculture to establish rules/regs. Did require every research facility submit an annual report that provided the number of regulated species used and assurance that professionally accepted standards for the care, treatment, and use of animals were followed - including use of anesthetic, analgesic, and tranquilizing drugs.
Institutions that used animals (except primary or secondary schools) for research, tests, or experiments were required to register - first time zoos needed to be licensed. Did NOT apply to horses not used in research and agricultural animals used in food and fiber research, retail pet stores, state and county fairs, rodeos, purebred dog and cat shows, and agricultural exhibitions.
Definition of “Animals” in 1970 Animal Welfare Act
Dogs, cats, NHPs, rabbits, guinea pigs, and hamsters, and, with certain exceptions, any other warm-blooded animal designated by the US Secretary of Agriculture.
Definition of “Dealer” in 1970 Animal Welfare Act
Any person who bought or sold any dog or other animal designated by the USDA for use in research, teaching, or exhibition or as a pet at the wholesale level.
Animal Welfare Act Amendment (PL-94-279) (1976)
Amended to include regulation of common carriers and intermediate handlers and to establish transportation standards for animals - shipping conditions and containers. Also prohibited interstate promotion or shipment of animals for animal fighting ventures.
Food Security Act (PL-99-198) (1985)
Included provisions to amend the AWA, referred to as “The Improved Standards for Laboratory Animal Act”:
1) The use of animals is instrumental in certain research
2) Methods of testing that do not use animals are being developed which are faster, less expensive, and more accurate than traditional animal experiments.
3) Measures which eliminate or minimize unnecessary duplication of experiments on animals can result in more productive use of federal funds
4) Measures which help meet the public concern for laboratory animal care and treatment are important to the continuation of research.
These amendments included specific requirements for research facilities related to the experimental use of animals. Still maintains that the Secretary of Agriculture CANNOT promulgate rules, regs, or orders with regard to the design or performance of research protocols. Also mandates that the USDA may not interrupt the conduct of research during inspections.
Pet Theft Act (PL-101-624) (1990)
4th amendment to AWA. Incorporated in the 1990 Food, Agriculture, Conservation, and Trade Act. Referred to as the “Protection of Pets” legislation. Established a 5-day holding period for dogs and cats held at pounds and shelters (both private and public) before release to dealers. Also allowed the USDA to seek injunctions against any licensed facility found dealing in stolen animals.
Helms Amendment (2002)
Amendment to the Farm Security and Rural Investment Act (2002 Farm Bill). Explicitly excluded rats, mice, and birds used for research from the Act. However, these animals are covered under the act for other purposes (zoos, aquaria). Rationale to accept their exclusion based in large part on the fact that these species are covered by other federal (PHS Policy) and private (AAALAC) systems of oversight.
Approximately what percentage of research using rats and mice is funded by the NIH and thus covered by the Health Research Extension Act/Public Health Service Policy?
~95%
What does the Animal Welfare Act authorize the USDA to do though the Secretary of Agriculture?
Develop standards, rules, regulations, and orders based on its content. All rules must be developed in consultation and cooperation with other federal departments and agencies and be reviewed and approved by the Office of Management and Budget.
What department within the USDA administers the Animal Welfare Act?
Animal and Plant Health Inspection Service (APHIS).
What is the process for the USDA to create new AWA regulations or changes?
Must publish changes in the Federal Register and allow for a 60-day public comment period. The final rule on the regulations is published in the Federal Register, along with the effective implementation date.
Where are the complete set of USDA regulations and standards published, regarding the AWA?
As the Animal Welfare Regulations in the Code of Regulations, Title 9, Animals and Animal Products, Subchapter A, Animal Welfare. Part 1 defines terms used, Part 2 provides the regulations, Part 3 specifies the standards, and Part 4 includes the rules of practice governing proceedings under the Animal Welfare Act.
Animal Care Policy Manual
Issued by the USDA to further clarify the intent of the Animal Welfare Act. Principle components of the animal welfare regulations that pertain to research facilities are provided in Part 2, Subparts C and D.
What are Regulated Species?
Any live or dead dog, cat, NHP, guinea pig, rabbit, hamster, aquatic mammal, or any other warm-blooded animals that is being used or is intended for use in research, teaching, testing, experimentation, or exhibition, or as a pet. Does NOT include birds, rats of the genus Rattus, and mice of the genus Mus bred for use in research, teaching, or testing, and horses and farm animals intended for use as food or fiber of used in studies to improve production and quality of food and fiber.
Define “dealer” under current AWA.
Any person who, for compensation or profit of more than $500 per year, buys, sells, or negotiates the purchase of, delivers for transportation, or transports a regulated animal for research, teaching, testing, experimentation, or exhibition or for use as a pet or a dog for hunting, security or breeding purposes.
Any person operating as a dealer, broker, exhibitor, or operator of an auction sale must be licensed by the USDA and pay an annual fee.
What pet stores are exempt as dealers under the AWA?
Traditional “brick and mortar” pet stores, unless they sell to a research facility, exhibitor, or wholesale dealer. USDA has begun requiring federal licensing and inspections for internet-based businesses.
What is the required holding period for dealers according to the USDA and AWA?
Dogs and cats acquired must be held for 5 full days, NOT including the day of acquisition, after acquiring the animal. If the animal was acquired from a contract animal pound or shelter, the animal must be held for at least 10 full days. If the animal is then sold to another dealer, the subsequent dealer must hold the animal for a minimum of 24 hours.
What is the holding period for research facilities that obtain dogs and cats from sources other than dealers, exhibitors, and exempt persons?
5 full days, NOT including the day of acquisition or time in transit, before the animals are used by the facility.
Define “research facility” according to the USDA, under the AWA.
Research facilities are any institution, organization, or person that uses live animals in research, testing, or experiments; that purchases or transports live animals; or that receives federal funds for research, tests or experiments.
What are the research facility registration requirements according to the USDA, under the AWA?
Research facilities, intermediate handlers, and common carriers of regulated species must register with the USDA every 3 years. Any revisions to the initial registration must be provided at the time of re-registration. The Secretary of Agriculture may exempt facilities from registration if they do not use cats, dogs, or a substantial number of other regulated species.
IACUC requirements of 1985 Animal Welfare Act
Required every animal research facility to establish an IACUC. Congress mandated that the committee include at least 3 members appointed by the chief executive officer of the research facility. Members must possess sufficient ability to assess animal care, treatment, and practices in experimental research and represent society’s concerns regarding animal subject welfare.
Minimum member requirements for IACUC according to AWA?
At least 3 members appointed by the chief executive officer of the research facility. At least one DVM. At least one non-affiliated member (cannot be an immediate family member of an affiliated member).
Up to how many IACUC members can be from the same administrative unit?
If the IACUC has more than 3 members, not more than 3 can be from the same administrative unit.
What are the IACUC reporting responsibilities to the Institutional Official (IO)?
Making recommendations to the IO regarding any aspect of the research facility’s animal program, facilities, or personnel training. Required to review, at least every 6 months, the facility’s program for humane care and use of animals, based on USDA regulations.
After each program review and inspection, the IACUC must file a report to the IO, signed by a majority of committee members and including any minority views expressed in members. The report MUST identify any deficiencies of USDA standards - deficiencies of animal care or treatment and any deviations in research practices from IACUC approved proposals. Must distinguish significant from minor deficiencies with a plan and schedule for correcting each deficiency.
Report must be maintained on file for at least 3 years and made available during inspections by the USDA or federal funding agencies.
How often must the IACUC conduct an inspection of all animal study areas and animal facilities?
At least every 6 months. Exceptions can be made by the Secretary of Agriculture - if animals are studied in their natural environment or the study area is difficult to access.
Define significant deficiency.
A deficiency that threatens animals health or safety.
What are the IACUC requirements for federal research facilities?
Same IACUC composition and responsibilities, except that they are to report deficiencies or deviations to the head of the federal agency conducting the research.
What information must be included in an IACUC proposal or amendment?
1) The species and approximate number of animals to be used
2) Rationale for involving animals and appropriateness of species and number to be used
3) Complete description of the proposed use of animals
4) Description of procedures designed to assure that discomfort and pain to animals will be limited to that which is unavoidable for the conduct of scientifically valuable research, including provision of pharmacologic agents
5) Description of euthanasia method
How often must ongoing IACUC protocols be reviewed?
No less than annually.
What are the requirements for potentially painful procedures on an IACUC protocol?
A veterinarian must be consulted. Sedatives, analgesics, or anesthetics must be provided, unless withholding them is scientifically justified in writing and approved by the IACUC - in these cases, the pain-relieving agents may be withheld only for the period of time necessary to meet research objectives.
What are the USDA regulations for survival surgeries in IACUC protocols?
Must be performed using aseptic technique and sterile instruments.
Surgical team must wear surgical gloves and masks.
Appropriate pre- and post-operative care must be provided.
Major survival surgery on non-rodents may only be conducted in facilities intended for that purpose and must be maintained under aseptic conditions.
What are the USDA regulations for multiple survival surgeries?
An animal may not be used in more than one major operative procedure from which it is allowed to recover, unless the additional procedure is scientifically justified in writing, required as a routine veterinary procedure, or required to protect the health or well-being of the animal.
In other special circumstances, requests for exemptions may be made to the administrator of the USDA’s APHIS.
What are the USDA regulations for IACUC oversight of animals’ living conditions?
The IACUC committee must be assured that the animals’ living conditions will be appropriate for their species. The housing, feeding, and nonmedical care of the animals must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species.
The IACUC must also be assured that personnel working with the animals are appropriately qualified and trained.
What is the Animal Welfare Act stance on trade secrets, commercial, and financial information?
The research facility is not required to disclose trade secrets or commercial or financial information publicly or to the IACUC. It is unlawful for any member of the IACUC to release any confidential information of the facility, including trade secrets, processes, operations, style of work, or apparatus.
The law also protects the identity, confidential statistical data, and amount of source of any income, profits, losses or expenditures of the research facility.
What are the potential consequences of an IACUC member breaching the AWA’s stance on trade secrets (confidential information)?
The committee member may be removed from the IACUC, fined, and imprisoned. Any individual or research facility injured in its business or property by reason of a violation of the confidentiality rules may recover all actual and consequential damages.
What are the personnel training requirements of the 1985 Animal Welfare Act?
1) All persons involved with animal care, treatment, and use must be qualified to perform their duties. 2) Each institution must require training on humane methods of animal maintenance and experimentation, including the based needs and proper handling and care of animals, pre- and post -procedural care, and methods of aseptic surgery.
3) Personnel must also be instructed about methods the minimize or eliminate the use of animals or limit animal pain or distress and the use of information services to help them search for alternatives.
4) Personnel must be informed about the methods to reports animal care and treatment deficiencies.
The 1985 Animal Welfare Act mandated that the Secretary of Agriculture establish information services at the National Agriculture Library (NAL). What services does the NAL provide?
1) Information pertinent to employee training.
2) Methods that could prevent unintended duplication of animal experimentation as determined by the needs of the research facility.
3) Improved methods of animal experimentation the could reduce or replace animal use and minimize pain and distress.
What branch of the National Agriculture Library (NAL) meets the requirements of the 1985 Animal Welfare Act?
The Animal Welfare Information Center, NAL
What are the requirements of the Attending Veterinarian under USDA regulations?
1) Each research facility is required to have an attending vet with training or experience in lab animal science and medicine.
2) Part-time or consulting vets must provide a written program of veterinary care and perform regularly scheduled visits to the facility.
3) The attending vet has direct or delegated program responsibility for activities involving animals at the facility - authorized to ensure the provision of adequate veterinary care.
4) Must ensure that all animals are observed at least once daily to assess their health and well-being.
5) Responsible for providing guidance to investigators and other personnel regarding appropriate handling, immobilization, anesthesia, anesthesia, tranquilization, and euthanasia of animals.
What is the USDA definition of “adequate veterinary care”?
Includes the availability of appropriate facilities, personnel, equipment and services. Also includes the use of appropriate methods to prevent, control, diagnose, and treat diseases and injuries and the provision of emergency veterinary medical care.
What records does the USDA require the IACUC to maintain?
1) Records of each IACUC meeting.
2) Records of each proposed activity involving animals, including any significant changes.
3) The status of IACUC approval for each activity or change.
4) The semi-annual IACUC reports and recommendations.
According to the USDA, each research facility must maintain what records concerning dogs and cats?
Records for any dog or cat purchased, owned, held, transported, euthanized, or sold.
These records must include the animal’s source and date of acquisition, USDA-designated unique ID tag or tattoo, species or breed, sex, date of birth or approximate age, any distinguishing physical characteristics.
What information needs to be maintained by a facility, according to the USDA, for the transportation, selling, or other disposition of a dog or cat?
The name and address of the carrier (if transported) and of the new owner (if sold or donated). With the exception of the source and date of acquisition, these records must accompany the animal shipment.
True or False: A heath certificate signed by a licensed veterinarian must accompany all shipments of dogs, cats, and NHPs.
True
How long must IACUC records be maintained, according to the USDA?
Records relating directly to activities approved by the IACUC must be maintained for the duration of the activity and for an additional 3 years after completion of the activity. These shall be available for inspection and copying by authorized APHIS or federal funding agency representatives.
When does each research facility need to submit an annual report to the USDA?
On or before December 1 of each calendar year. Should include information to the immediately preceding fiscal year (October 1 - September 30).
What things must a facility’s USDA annual report ensure and include?
1) The professionally acceptable standards governing the care, treatment, and use of animals were followed.
2) The each principal investigator has considered alternatives to painful procedures.
3) That the facility is adhering to the USDA standards and regulations, unless the IACUC has approved exceptions specified and explained by the PI.
4) A summary of any exceptions, including a brief explanation and the species and number of animals affected.
5) The location of all facilities where animals were housed or used in actual research, testing, teaching, or experimentation, or held for these purposes.
6) The common names and numbers of animals used.
7) The number of animals being bred, conditioned, or held for use, but not yet used.
What 3 categories must animal numbers be reported in within an annual USDA report?
1) Activities involving no pain, distress, or use of pain-relieving drugs.
2) Activities where appropriate anesthetic, analgesic, or tranquilizing drugs were used.
3) Painful activities where the use of pain-relieving drugs would have adversely affected the procedures, results, or interpretation of the activity.
An explanation of this third category must be included in the report.
What does the USDA do with information from facility annual reports?
Compiles information contained in reports from all registered facilities and submits an annual summary to Congress.
Describe the USDA Standard: Canine Opportunity for Exercise
Dealers, exhibitors, and research facilities must develop, document, and follow an appropriate plan, approved by the attending veterinarian, to provide dogs over 12 weeks of age with the opportunity for exercise.
Also, dogs housed in the same primary enclosure must be compatible.
In what situations are dogs exempt from the USDA Standard: Canine Opportunity for Exercise?
1) Individually housed dogs with at least twice the minimum flood space required.
2) Dogs that are group-housed in floor space that meets the minimum space standards for each dog.
3) Bitches with litters.
4) Incompatible, aggressive, or vicious dogs.
5) Attending vet may also exempt dogs from this program if participation would adversely affect the dog’s health or well-being.
6) IACUC may also approve exemptions if the PI determines that it is inappropriate for certain dogs to exercise or be group-housed - this exemption must be reviewed annually by the IACUC.
How are USDA Standard: Canine Opportunity for Exercise exemptions documented?
Exemptions must be documented and reviewed at least every 30 days by the veterinarian, unless the condition is permanent.
What social contact must be provided for dogs housed without sensory contact with another dog?
This dog must be provided with positive contact with humans at least daily.
Describe the USDA Standard: Psychological Well-Being of Nonhuman Primates.
Dealers, exhibitors, and research facilities must develop, document, and follow an appropriate plan for environmental enhancement adequate to promote the psychological well-being of NHPs.
The plan must be in accordance with currently accepted professional standards as cited in professional journals or reference guides and as directed by the attending veterinarian.
At a minimum, the plan must address the social needs of NHPs known to exist in social groups in nature.
In what situations are NHPs exempt from the USDA Standard: Psychological Well-Being of Nonhuman Primates?
1) Individuals that are vicious, overaggressive, or debilitated should be individually housed.
2) NHPs that are suspected of having a contagious disease must be isolated.
How is it determined that group-housed NHPs are compatible?
Must be based in accordance with generally accepted professional practices and by actual observations, as directed by the AV.
What social contact must be provided to individually housed NHPs?
Individually housed NHPs must be able to see and hear members of their own or a compatible species, unless the AV determines this arrangement would endanger their health, safety, or well-being.
What groups of NHPs requires special attention according to the USDA Standards?
1) Infant and young juvenile NHPs
2) Those that exhibit signs of psychological distress
3) Those entered in IACUC-approved protocols that require restricted activity
4) Individually housed NHPs without sensory contact with NHPs of their own or another compatible species
Great apes weighing more than ______ must be provided additional opportunities to express species-typical behavior.
110 lbs
What are the USDA Standards guidelines for restraint of NHPs?
Restraint must be for the minimum period possible.
If the protocol requires more than 12 hr of continuous restraint, the NHP must be provided the daily opportunity for at least 1 continuous hour of unrestricted activity, unless the IACUC approves an exception. Such an exception must be reviewed annually.
How often must the attending veterinarian review the exemption of an NHP from the environmental enhancement plan?
Every 30 days.
All exemptions must be available for review by the USDA and federal funding agencies upon request and reported in the annual report to the USDA.
What is the role of the Animal Care section of USDA APHIS?
Responsible for ensuring compliance of transporation, sale, and handling of animals used in laboratory research.
How often must USDA inspect research facilities according to the AWA?
At least annually. In the case of deficiencies or deviations from the standards promulgated under the act, the Act requires the USDA to conduct follow-up inspections as necessary until all deficiencies or deviations are corrected.
How does the USDA Animal Care section enforce the AWA?
Through unannounced inspections, and investigations may also be conducted as a result of alleged violations of the AWA, in response to public or internal complaints.
Animal Care uses a risk based assessment system, which allows inspectors to conduct more frequent and in-depth inspections at problem facilities and fewer (though no less than annual) at facilities that are consistently in compliance.
What is each facility required to permit APHIS officials to do?
1) Enter its place of business
2) Examine and make copies of the required records
3) Inspect facilities, property, and animals
4) Document by taking photographs and other means, conditions and areas of noncompliance
What actions may be taken in response to an AWA violation?
1) Official notice of warning or a stipulation offer, which allows the institution to pay a penalty in lieu of formal administrative proceedings
2) For serious or chronic violations - a Department-level review with issuance of a formal administrative complaint, which may be resolved by licensing suspensions, revocations, cease-and-desist orders, civil penalties or a combination of these penalties.
What can be searched online through the Animal Care Information System?
Inspection reports, including animal inventories, inspection report citations, and the number of animals used in medical research.
Health Research Extension Act (PL-99-158) (1985) Section 495, Animals in Research
Mandates the Secretary of Health and Human Services, acting through the Director if the NIH, to establish guidelines for the proper care and treatment of animals used in biomedical and behavioral research.
What institutions are required to provide extensive written assurance of their compliance with the PHS Policy on Humane Care and Use of Laboratory Animals (OLAW, 2002)?
Any institution receiving support through the US Public Health Service for animal research, training, biological testing, or aninal-related activities. The policy applies to all animal-related activities, regardless of where they are conducted.
