Chapter 2. Laws, Regulations, and Policies Affecting the Use of Laboratory Animals Flashcards
(179 cards)
1
Q
28-Hour Law (1873)
A
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.
2
Q
Laboratory Animal Welfare Act (PL-89-544) (1966)
A
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.
3
Q
Animal Welfare Act (PL-91-579) (1970)
A
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.
4
Q
Definition of “Animals” in 1970 Animal Welfare Act
A
Dogs, cats, NHPs, rabbits, guinea pigs, and hamsters, and, with certain exceptions, any other warm-blooded animal designated by the US Secretary of Agriculture.
5
Q
Definition of “Dealer” in 1970 Animal Welfare Act
A
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.
6
Q
Animal Welfare Act Amendment (PL-94-279) (1976)
A
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.
7
Q
Food Security Act (PL-99-198) (1985)
A
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.
8
Q
Pet Theft Act (PL-101-624) (1990)
A
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.
9
Q
Helms Amendment (2002)
A
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.
10
Q
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?
A
~95%
11
Q
What does the Animal Welfare Act authorize the USDA to do though the Secretary of Agriculture?
A
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.
12
Q
What department within the USDA administers the Animal Welfare Act?
A
Animal and Plant Health Inspection Service (APHIS).
13
Q
What is the process for the USDA to create new AWA regulations or changes?
A
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.
14
Q
Where are the complete set of USDA regulations and standards published, regarding the AWA?
A
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.
15
Q
Animal Care Policy Manual
A
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.
16
Q
What are Regulated Species?
A
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.
17
Q
Define “dealer” under current AWA.
A
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.
18
Q
What pet stores are exempt as dealers under the AWA?
A
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.
19
Q
What is the required holding period for dealers according to the USDA and AWA?
A
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.
20
Q
What is the holding period for research facilities that obtain dogs and cats from sources other than dealers, exhibitors, and exempt persons?
A
5 full days, NOT including the day of acquisition or time in transit, before the animals are used by the facility.
21
Q
Define “research facility” according to the USDA, under the AWA.
A
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.
22
Q
What are the research facility registration requirements according to the USDA, under the AWA?
A
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.
23
Q
IACUC requirements of 1985 Animal Welfare Act
A
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.
24
Q
Minimum member requirements for IACUC according to AWA?
A
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).
25
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.
26
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.
27
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.
28
Define significant deficiency.
A deficiency that threatens animals health or safety.
29
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.
30
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
31
How often must ongoing IACUC protocols be reviewed?
No less than annually.
32
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.
33
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.
34
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.
35
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.
36
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.
37
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.
38
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.
39
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.
40
What branch of the National Agriculture Library (NAL) meets the requirements of the 1985 Animal Welfare Act?
The Animal Welfare Information Center, NAL
41
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.
42
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.
43
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.
44
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.
45
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.
46
True or False: A heath certificate signed by a licensed veterinarian must accompany all shipments of dogs, cats, and NHPs.
True
47
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.
48
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).
49
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.
50
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.
51
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.
52
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.
53
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.
54
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.
55
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.
56
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.
57
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.
58
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.
59
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.
60
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
61
Great apes weighing more than ______ must be provided additional opportunities to express species-typical behavior.
110 lbs
62
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.
63
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.
64
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.
65
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.
66
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.
67
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
68
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.
69
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.
70
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.
71
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.
72
Most federally funded research in the US is funded through which Department?
Department of Health and Human Services, including the NIH, CDC, FDA, and EPA.
73
What is the function of the Office of Laboratory Animal Welfare (OLAW)?
Responsible for the implementation, interpretation, and evaluation of compliance with the PHS Policy and for the education of institutions and investigators receiving PHS support. Also responsible for conducting site visits to selected institutions and evaluating allegations of noncompliance with PHS Policy.
74
True of False: No activity involving animals may be conducted or supported by the PHS unless the institution has an approved written Animal Welfare Assurance on file with OLAW.
True.
75
How often must an institution submit a new Animal Welfare Assurance to OLAW?
At least every 5 years.
76
If significant problems are identified during an OLAW inspection of a facility for compliance with the PHS Policy, who may suspend or revoke funding to an individual investigator or institution?
The Director of the NIH.
77
What are the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training? (1985)
I. Transportation, care, and use of animals should be in accordance with the AWA and other applicable Federal laws, guidelines, and policies.
II. Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.
III. The animals selected for a procedure should be of appropriate species and quality and the minimum number required to obtain valid results. Should consider other methods as well (mathematical, computer simulation, in vitro).
IV. Proper use of animals - avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices - is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in humans cause pain or distress in other animals.
V. Procedures that cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals.
VI. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure.
VII. Living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally the housing, feeding, and care of all animals used for biomedical research must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species. In any case, veterinary care shall be provided as indicated.
VIII. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangement shall be made for their in-service training, including proper and humane care and use of lab animals.
IX. Where exceptions are required in relation to these Principles, the decisions should not rest with the investigators directly concerned but should be made, with due regard to Principle II, by an appropriate review group such as the IACUC. Such exceptions should NOT be made solely for the purposes of teaching or demonstration.
78
Who developed the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training (1985)?
The Interagency Research Animal Committee (IRAC).
79
What policies do the PHS Policy and OLAW follow?
1. PHS Policy implements the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training (IRAC, 1985).
2. PHS Policy requires institutions to use the Guide (NRC, 2011a) as the basis for developing and implementing an institutional program for activities involving animals.
3. PHS Policy requires euthanasia of animals be conducted in accordance with the AVMA Guidelines for the Euthanasia of Animals: 2020 Edition.
4. OLAW also refers to the NIH Revitalization Act of 1993, Plan for Use of Animals in Research.
80
What is the NIH Revitalization Act of 1993 (PL-103-43), Plan for Use of Animal in Research?
Requires the Director of the NIH to prepare a plan:
1. For the NIH to conduct or support research into:
a. Methods of biomedical research and experimentation that do do require the use of animals.
b. Methods of such research and experimentation that reduce the number of animals used.
c. Methods of such research and experimentation that produce less pain and distress in animals.
d. Methods of such research or experimentation that involve marine life (other than marine mammals).
2. For establishing the validity and reliability of the method(s) described in paragraph 1.
3. For encouraging the acceptance by the scientific community of such methods that have been found to be valid and reliable.
4. For training scientists in the used of such methods that have been found to be valid and reliable.
81
To what animals does the Guide (NRC, 2011a) apply?
All live vertebrate animals, including traditional laboratory animals, farm animals, wildlife, and aquatic animals used in research, testing, or teaching.
82
Define Category 1 by the PHS Policy.
An AAALAC International accredited institution. Not required to submit their most recent semiannual report to OLAW with the assurance statement.
83
Define Category 2 by the PHS Policy.
An institution that is not accredited by AAALAC International. Required to submit their semiannual report to OLAW.
84
What are the differences between the PHS Policy and the AWA for IACUC requirements?
Unlike the AWA, the PHS Policy requires:
1. At least 5 (NOT 3) members, including a DVM, a practicing scientists with experience in animal research, an individual whose primary concerns are in a nonscientific area, and an individual who is not affiliated with the institution in any way other than the IACUC. One person may meet more than one of these four requirements, provided there is a minimum of 5 IACUC members.
85
What is the difference between the PHS Policy and USDA regulations for IACUC reporting?
USDA regulations require annual review of ongoing activities.
PHS Policy requires the IACUC to conduct a complete review at least once every 3 years
86
How long must IACUC records be maintained according to PHS Policy?
Records - including IACUC minutes; applications, proposals, and proposed significant changes in the care of use of animals and their respective IACUC evaluation; IACUC semiannual reports and recommendations; records of accrediting body determinations - must be obtained for 3 years.
Records related to IACUC-approved activities must be held for 3 years beyond the completion of the activity.
All records must be accessible for review and copying by an authorized OLAW or other PHS representative.
87
According to the PHS, how often must the IACUC report to OLAW through the Institutional Official?
At least once every 12 months.
88
What does the IO's annual report to OLAW need to include?
Any changes in the institution's accreditation status, program for animal care and use, or IACUC membership, as well as the dates of the IACUC's semiannual evaluations of the institution's programs and facilities.
89
What does the federal Food, Drug, and Cosmetic Act require of the FDA?
Requires the FDA, under the DHHS, to ensure proper procedures for the care and use of laboratory animals., as implemented by the GLP regulations.
90
Good Laboratory Practice (GLP) regulations (21 CFR, Part 58) - became effective 1979, most recent amendment 2002.
Regulations establish basic standards for conducting and reporting nonclinical safety testing and are intended to ensure the quality and integrity of safety data submitted to the FDA in support of an application for a research or marketing permit.
91
When is a research or marketing permit from the FDA needed?
These permits are required for human or animal drugs, human biological products, medical devices, diagnostic products, food and color additives, and electronic medical products.
92
What types of studies are NOT covered by GLP?
Basic research studies, clinical or field trials in animals, and human subject trials.
93
What is required of institutions seeking FDA approval of their products?
1. Written protocols and SOPs
2. Adequate facilities, equipment, and animal care
3. Proper identification of test substances
4. Accurate recordings of observations and results of preclinical studies.
The FDA relies heavily on documented adherence to written protocols and SOPs in support of marketing or clinical research permits.
94
What is a study director?
Under GLP regulations, every study conducted must have a study director, who is ultimately responsible for the implementation of the protocol and conduct of the study.
95
What is a quality-assurance unit?
Under GLP regulations, each institution must have a quality-assurance unit that monitors the conduct of studies to ensure that the protocol is being followed and the records are properly maintained.
96
Describe inspections conducted by the FDA for GLP.
To ensure compliance with GLP regulations, the FDA conducts periodic, routine surveillance inspections and data audits of public, private, and government nonclinical laboratories.
Directed inspections may also be conducted to verify the reliability, integrity, an compliance of important or critical safety studies being reviewed in support of pending applications for product research or premarketing approval.
FDA may also conduct inspections to investigate potential noncompliance issues brought to the FDA by whistle-blowers, the news media, industry complaints, FDA reviewers, other government contracts, or other sources.
97
When are FDA inspections announced or conducted without prior notification?
Inspections of commercial labs are conducted without prior notification.
Initial inspections of university and government labs are initiated only after the facility has been informed in a letter from the Bioresearch Monitoring Program coordinator, Division of Compliance Policy, Office of Enforcement, FDA, of the intent to inspect.
98
Who sends letters to university and government labs to notify them of the FDA's intent to inspect?
The Bioresearch Monitoring Program coordinator, Division of Compliance Policy, Office of Enforcement, FDA.
99
What do FDA inspections include?
Review of institution's organization and personnel, quality-assurance unit, facilities, equipment, testing facility operations, reagents and solutions, test and control articles, protocols and conduct of nonclinical studies, records, and reports.
The animal care program is also evaluated to determine if it is adequate - animal housing rooms; SOPs for environment, housing, feeding, handling, and care.
100
What are the aspects of appropriate animal care and housing according to the FDA for inspections?
1. Newly received animals must be appropriately isolated, identified, and evaluated for health status.
2. Animals of different species, or animals of the same species on different projects, must be separated.
3. Daily logs of animal health observations (are randomly reviewed during FDA inspection).
4. Treatment of animals must be authorized and documented.
5. Cages, racks, and accessory equipment must be cleaned and sanitized, and appropriate bedding must be used.
6. Feed and water samples must be collected at appropriate sources and analyzed periodically.
7. A pest control program must also be in place.
8. Copies of the IACUC's SOPs and meeting minutes are available for review.
101
What are the components of an FDA data audit?
Compares the protocols and amendments, raw data, records, and specimens against the final safety assessment report. The study methods described in the final report are compared against the protocol and SOPs to confirm that the GLP requirements were met. Includes review of procedures and methods for animal housing, identification, health observations, and treatment; handling of dead or moribund animals and necropsy, histopathology, and pathology procedures. The audit also includes a detailed review of study records and raw data (animal weight records, food consumption records, clin path analyses, ophthalmologic exams, etc.).
102
What are the actions the FDA may take if objectionable conditions or practices are found during GLP inspection?
FDA may hold an informal conference, conduct a re-inspection, issue a warning letter, reject a nonclinical study or studies, disqualify the institution, withhold or revoke a marketing permit, or terminate a permit for preclinical studies.
103
What federal interagency cooperations are required by Congress through the Animal Welfare Act?
The Secretary of Agriculture must consult with the Secretary of Health and Human Services prior to the issuance of regulations.
104
Memorandum of Understanding (MOU) concerning Laboratory Animal Welfare (1995; last updated Jan 18, 2011 - updates valid for 5 years).
Signed by authorized representatives of the USDA, NIH, and FDA and these agencies made the following agreements based on mutual concern and interest regarding animal welfare:
1. To share information contained in agency registries, inventories, and listings of organization that fall under their respective authority.
2. To share information pertaining to significant adverse findings regarding animal care and use and the actions taken by the agency in response.
3. To share evidence of serious noncompliance with required standards or policies for the care and use of laboratory animals.
4. To coordinate successive evaluations and to avoid redundant evaluations of the same entities.
5. To consult and coordinate with each other on regulatory or policy proposals and significant policy interpretations.
6. To provide each other with resource persons for scientific and educational seminars, speeches, and workshops related to lab animal welfare.
7. To limit dissemination of shared information received to internal agency officials with a need to know and to refer and FOIA requests for records provided by another agency to the agency that provided the records.
105
How is the MOU between the USDA, NIH, and FDA implemented?
Each agency appoints a liaison to a standing committee which is charged with facilitating implementation of the MOU. The committee is required to meet no less than 2 times per year to review the effectiveness of the agreement, suggest modifications, and to address any urgent issues and specific cases of serious noncompliance.
106
Memorandum of Understanding between the NIH and the U.S. Department of Veterans Affairs (VA), Office of Research Oversight, and Office of Research and Development.
Objectives of this MOU are to:
1. Maintain and enhance agency effectiveness by coordinating efforts and sharing resources and information, especially those related to education and compliance
2. Avoid duplication of effort in achieving standards for the care and use of lab animals
3. Promote harmonization among VA-sponsored activities and between VA institutions and other PHS Assured institutions
4. Consulting with regard to investigations of noncompliance at VA institutions and sharing info relevant to VA compliance with the PHS Policy
5. Committing OLAW to provide substantive review and consultation of internal VA policies and educational materials to ensure compliance with PHS Policy and to harmonize standards
6. Negotiating Animal Welfare Assurances for VA or VA-affiliated institutions that do not receive direct PHS support for activities involving live vertebrate animals
7. Working collaboratively to co-sponsor educational meetings and workshops and to collaborate on online training.
107
Approximately how many medical and academic institutions formally collaborate with the VA in conducting human and animal research, but do not receive direct PHS support for animal work?
More than 75.
108
According to the MOU between the NIH and the VA, who maintains exclusive purview of interpretation of and determination of noncompliance with PHS Policy?
OLAW.
109
What is the role of EPA?
Regulates chemicals and monitors compliance with environmental laws and regulations designed to reduce pollution to protect public health and the environment. The EPA monitors 44 statutory programs.
110
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (enacted in 1947)
Authorizes the administrator of the EPA to register and control the use of pesticides.
111
Describe how the EPA registers a new pesticide.
The EPA conducts a premarket review of its potential health and environmental effects. Animal tests must be conducted according to the EPA GLPs.
112
What is covered by the EPA GLPs?
Studies related to health effects, environmental effects, and chemical fate testing.
113
Toxic Substances Control Act (TSCA) (1976)
Provides EPA with authority to require reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures.
The TSCA also addresses the production, importation, use, and disposal of specific chemicals including polychlorinated biphenyls (PCBs), asbestos, radon, and lead-based paint.
114
List substances generally excluded from the TSCA.
Food, food additives, drugs, cosmetics, and pesticides.
115
Final rule of the TSCA - 1983
TSCA also stipulates the use of GLP standards for conducting chemical studies required by the Act.
116
Working Group on the Use of Chimpanzees in NIH-Supported Research
Group convened by the NIH after accepting the December 2011 Institute of Medicine (IOM) report, Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity (NRC, 2011b), to advise on implementation of the report.
117
Institute of Medicine (IOM) report, Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity (NRC, 2011b) (December 2011)
Published in January 2013 and contained 28 recommendations and was made available for public comment.
118
What are the plans of the NIH Working Group on the Use of Chimpanzees?
1. Retain but not breed up to 50 chimpanzees for future research that meets the IOM principles and criteria.
2. Provide ethologically appropriate facilities for those chimps as defined by the NIH, with space requirements yet to be determined.
3. Establish a review panel to consider research projects proposing the use of chimps with the IOM principles and criteria after projects have cleared the NIH peer review process.
4. Wind down research projects using NIH-owned or -supported chimps that do not meet the IOM principles and criteria in a way that preserves the research and minimizes the impact on the animals.
5. Retire the majority of the NIH-owned chimps deemed unnecessary for biomedical research to the Federal Sanctuary System contingent upon resources and space availability in the sanctuary system.
119
U.S. Fish and Wildlife Service, 2013 action regarding chimpanzees.
US FWS proposed classifying chimps as endangered. After receiving a petition in 2010 from a coalition of organization, including the Jane Goodall Institute, to list all chimps as endangered, the FWS conducted a formal review of the status of chimps in the Endangered Species Act (ESA). The FWS determined that the ESA does not allow for captive-held animals to be assigned a separate legal status from their wild counterparts.
120
What activities require permits because chimpanzees are considered endangered?
Import and export of chimps into and out of the US, "take" (defined by the ESA as harm, harass, kill, injure, etc.) within the US, and interstate and foreign commerce. Permits could be issued for scientific purposes or to enhance the propagation or survival of the animals.
121
National Academy of Sciences
Non-governmental, nonprofit organization chartered by Congress in 1863 to "investigate, examine, experiment, and report upon any subject of science or art...whenever called upon by a federal agency, a group internal to the NRC, or Congress."
122
Institute of Laboratory Animal Research (ILAR)
A component of the Division on Earth and Life Studies, one of six subject area divisions in the NRC.
Advised by a council of experts in lab animal medicine, zoology, genetics, medicine, ethics, and related biomedical sciences. ILAR published the Guide and several other standard references that are used to establish and maintain optimal animal care and use programs.
123
National Research Council (NRC)
Operated jointly by the National Academy of Sciences, and the National Academy of Engineering. Is the organizational unit within the National Academies that conducts most policy studies at the request of the federal government.
124
AAALAC International
Founded in 1965. Private, nonprofit organization the promotes the humane treatment of animals in science through a voluntary accreditation program, a program status evaluation service, and educational programs. Based on performance standards and professional judgment.
125
What are the Three Primary Standards relied on by AAALAC International for assessments and animal care and use programs?
The Guide, the Guide for the Care and Use of Agricultural Animals in Research and Teaching (Ag Guide: FASS, 2010), and the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes, Council of Europe (ETS 123) 1986.
126
Who conducts on-site AAALAC International assessments?
It is a peer review including a member of AAALAC's Council on Accreditation and at least one ad hoc Consultant/Specialist. The Council is comprised of highly accomplished animal care and research professionals from around the globe.
127
Who governs AAALAC International?
A Board of Trustees comprised of representatives of Member Organizations, a select group of prestigious scientific, professional, and educational groups with an interest in advancing biomedical research and animal well-being in science. Includes: the American Association for the Advancement of Science (AAAS), the Federation of American Societies for Experimental Biology, the Society for Neuroscience, Society of Toxicology, and more than 60 other professional scientific, veterinary medical, and patient advocacy organizations.
128
Guide for the Care and Use of Agricultural Animals in Research and Teaching.
First ed 1988, revised in 1999 and 2010 by the Federation of Animal Science Societies. The third edition of the Ag Guide is based on the premise that the housing and management of farm animals do not necessarily change because of the objectives of the research or teaching activity.
129
Describe the OLAW restrictions on the breadth of applicability of the Ag Guide for PHS Assured institutions.
The Ag Guide primarily refers to agricultural animals used in agricultural research for which the scientific objectives are to improve understanding of the animals' use in production agriculture. Therefore, it is inappropriate to substitute the Ag Guide for the Guide based on the species of animal. However, there may be some circumstances where it is appropriate to follow the standards of the Ag Guide in biomedical research.
130
World Organisation for Animal Health (OIE)
Founded in 1924 as the Office International des Epizooties (OIE). Renamed in 2003.
Mission of creating a framework of international collaboration and information sharing to improve animal health and welfare. 182 Member countries. Recognized as a reference organization for the World Trade Organization. Publishes standards (mostly animal health and zoonoses) develop by expert groups on terrestrial and aquatic animals.
131
How many member countries are in OIE?
182.
132
OIE 2001-2005 Strategic Plan
Identified animal welfare as a priority. Subsequently, the OIE convened the Working Group on Animal Welfare.
133
OIE Working Group on Animal Welfare
Initially focused on standards relating to the long distance transport of animals, and the killing of animals for human consumption and disease control purposes. More recently, added lab animal welfare as an area of interest.
134
OIE Ad Hoc laboratory animal expert committee
Convened with representation from US, Canada, Europe, Asia, Africa, and South America to develop standards based on lab animal care and use.
135
Terrestrial Animal Health Code (OIE, 2011)
The governments of member countries have a responsibility to ensure these standards are reflected in their regulatory frameworks. Lab animal standards are in Chapter 7.8, for Use of Animals in Research and Education.
136
Council for International Organizations of Medical Sciences (CIOMS)
Established by WHO and the United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1949. 48 international member organizations representing biomedical disciplines and 18 national members representing national academies of sciences and medical research councils.
137
CIOMS International Guiding Principles for Biomedical Research Involving Animals.
First promulgated in 1985. 11 Principles (summarized):
1. Animals play a vital role in scientific activities. Decisions regarding the welfare, care, and use of animals should be guided by scientific knowledge and professional judgment.
2. The use of animals for science and education carries moral obligations and responsibilities to ensure welfare of these animals to the greatest extent possible.
3. Three Rs. Animals should only be used when necessary and scientifically and ethically justified.
4. Animals selected should be suitable for the purpose and of appropriate species and genetic background to ensure scientific validity and reproducibility. The care of these animals should be appropriate to the planned use as determined by scientific and veterinary medical experts and/or the literature.
5. Animal health and welfare should be primary considerations in decisions regarding the program of veterinary medical care. Measures should be taken to ensure that the animals' environment and management are appropriate for the species and contribute to the animals' well-being.
6. The welfare, care, and use of animals should be under the supervision of a veterinarian or scientist trained and experienced in the health, welfare, proper handling, and use of the species.
7. Investigators should assume that procedures that would cause pain or distress in human beings cause pain or distress in animals, unless there is evidence to the contrary.
8. Endpoints and timely interventions should be established for both humane and experimental reasons
9. Personnel responsible for the welfare, care, and use or animals are qualified and competent through training and experience.
10. A system of animal use that verifies commitment to the Principles should be implemented in each country.
138
U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training
Based on the CIOMS International Guiding Principles for Biomedical Research Involving Animals.
139
Revised CIOMS-ICLAS Guiding Principles (2012)
Collaboration with the International Council for Laboratory Animal Science (ICLAS). Like the original 1985 Principles, are intended to be used by the international scientific community to guide institutions in the responsible use of vertebrate animals in scientific and/or educational activities.
140
Who issued a notification that PHS-Assured institutions outside the U.S. are required to implement the revised CIOMS-ICLAS Guiding Principles?
OLAW.
141
Regarding animal transport, what is the role of the USDA, APHIS, Veterinary Services (VS) and National Center for Import and Export (NCIE)?
1. Facilitate international trade
2. Monitor the health of animals presented at the border
3. Regulate the import and export of animals, animal products, and biologics to protect the US's agricultural resources
4. Regulate the import and transport of infectious organisms and vectors of disease agents (not only animals and animal by-products - also biological materials that contain or have been in contact with certain organisms or animal materials (including cell cultures and recombinant products)
142
How must all imported materials enter the U.S.?
Through USDA-designated ports of entry. The regulations are set forth in the Code of Federal Regulations (CFR), Title 9, Chapter 1 (CFR 1998a, CFR 1998b)
Each shipment should be accompanied by documentation that confirms that animals have not been inoculated with or exposed to any livestock or poultry disease agents exotic to the US.
143
What is the individual designated to receive imported material responsible for?
Apply for a USDA permit by submitting a complete VS application form and applicable fee.
Importation of cell lines and cell culture products, such as monoclonal antibodies and recombinant proteins, requires an additional form. The information provided must be sufficient for the VS to evaluate disease risk and should include details regarding product processing, production, and nutrient factors.
144
To protect the health of U.S. livestock and poultry, the importation of which species requires a USDA permit for importation?
Swine, ruminants, other hoof stock, poultry, and other birds, including avian eggs for research purposes.
145
Department of Homeland Security, Customs, and Border Protection Agricultural Specialists
Material derived from any animal is potentially subject to USDA regulations and must be cleared by these specialists prior to entry into the U.S.
146
Who has regulatory authority over the importation of live laboratory animals or laboratory mammal material (including transgenic/knock-out mice and rats, hamsters, gerbils, guinea pigs, rabbits, ferrets, and their blood, tissue, DNA, extracts, antibodies, feces, sera, and antisera) for research purposes, IF they have NOT been inoculated with or exposed to any livestock or poultry disease agents exotic to the U.S., and do not originate from facilities where work with exotic disease agents affecting livestock or avian species is conducted?
CDC.
147
What is the volume limit on importation of lab animal blood, sera, antibodies, or antisera into the U.S.?
Less than 1 liter.
148
USDA Guidelines for importation #1103 (1998)
Cell lines and other products of cell lines, including monoclonal antibodies, which are not derived from livestock or avian species; are for in vitro use; have not been exposed to livestock or avian disease agents exotic to the U.S.; and do not produce antigens or contain genes of livestock of avian diseases agents or do not produce monoclonal antibodies directed against livestock or avian disease agents may be imported into the U.S. without a permit.
149
What human and NHP materials can be imported into the US without a USDA permit?
1. Are not produced in tissue culture
2. Are not actual zoonotic pathogens
3. Are not potential zoonotic pathogens
150
What agency issues permits for the introduction of genetically engineered organisms that pose a plant pest risk, including insects and microbes?
APHIS
151
USDA, APHIS, and Plant Protection and Quarantine (PPQ) service
Regulates the importation of plants ad other vegetable matter.
Feed provided to animals during transit may be regulated - importer must consult with the PPQ Permit Office to determine entry requirements and if an item cannot be allowed entry, it must be removed from the cage at the point of entry by a PPQ officer.
152
DHHS-CDC regulations on the importation of NHPs (42 CFR 71.53, 2013)
Went into effect on April 16, 2013.
1. Importers will no longer have to obtain a separate special permit in order to import African green, rhesus macaques, or cynomolgus monkeys into the US, but all importers will be required to meet all the standards of that were previously listed on the special permit.
2. Any Old World primates that die or are euthanized during the 31-day quarantine period must be tested (antigen capture test) for filovirus infection
3. Antibody testing is required for all Old World primates that exhibit signs consistent with filovirus infection during quarantine - this testing must be done at the end of the quarantine period and before the cohort of primates is released from quarantine
4. Entry of NHPs into the U.S. is restricted to those ports of entry where CDC Quarantine Stations are located, except in limited circumstances approved in writing in advance by the CDC
5. Quarantine requirements are removed for laboratory-to-laboratory transfers that meet certain criteria
153
What criteria must be met to remove the NHP quarantine requirement for entry to the U.S.?
Is a lab-to-lab transfer
1. The lab must have both a foreign-based and a US-based facility
2. The NHP must be part of an ongoing research project that have been approved by an IACUC
3. The recipient lab must be registered with CDC and must submit veterinary medical records documenting the primates' current and past health history, including testing for TB
4. US-based labs must be licensed by the USDA; AAALAC accreditation is desirable
5. The foreign-based lab must be accredited by a comparable accrediting agency
6. Justification must be provided to the CDC describing the reason a transfer to a US lab is necessary
7. A specific and detailed travel itinerary must be submitted to CDC
Only institutions or individuals registered with the CDC may import NHPs or receive them within a 31-day period of their arrival to the US
154
Under the new DHHS/CDC NHP importation provision, what is the required worker protection plan?
Importers must have a written worker protection plan for anyone whose duties may result in exposure to NHPs, including procedures for appropriate response measures in the event of an emergency. The plan is designed to ensure that personnel who work with or around NHPs are educated on the risks and have proper PPE.
Importers are registered for a 2-year period and must comply with CDC record-keeping and reporting requirements.
155
What are the importation requirements managed by PHS?
PHS is responsible for protecting humans from zoonotic diseases.
1. Dogs must have a certificate showing they have been rabies vaccinated at least 30 days prior to US entry
2. Proof of rabies vaccination is NOT required for cats; however, some states may require this
3. Also regulates the importation or subsequent distribution of any etiologic agent or any arthropod or animal host or vector of human disease.PHS permits must be obtained for importation and distribution of these materials.
156
What are the CDC regulations on importation to the US of reptiles?
The CDC does not regulate snakes or lizards, but does limit imports of small turtles, tortoises, and terrapins, as well as their viable eggs.
1. Turtles with a carapace length of less than 4 inches and turtle eggs may not be imported for any commercial purpose
2. An individual may import as many as 6 small turtles OR eggs OR any combination totaling 6 or fewer turtles and eggs for non-commercial purposes
157
What is the CDC stance on importation into the US of birds?
The CDC has rescinded its restriction on the importation of birds and bird products, but does support the USDA/APHIS in its ongoing regulations to prohibit or restrict the importation of birds, poultry, or unprocessed birds and poultry products (such as eggs or feathers) from countries where highly pathogenic avian flu (HPAI H5N1) has been confirmed in poultry
158
Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) - established in 1973 and amended in 1979.
Protects wild flora and fauna from extinction by requiring government permits for international trade in threatened wildlife and wildlife products.
Applies to all designated vertebrate and invertebrate animal or plant species, whether alive or dead, and any recognizable part of a designated animal.
Protection is provided for species in 2 main categories:
1. Those that are most endangered
2. Other species at serious risk
159
What agency enforces CITES in the US?
FWS
160
Describe the 3 species appendices of CITES.
Appendix I: most endangered species
Appendix II: species that are not currently threatened with extinction but may become so unless trade is subject to strict regulation
Appendix III: all species that any country identifies as being subject to regulation within its jurisdiction for the purpose of preventing or restricting exploitation and for which the cooperation of other countries is needed. Import or export of these species requires appropriate documentation.
161
Endangered Species Act (1973) (50 CFR, Chapter IV, Subchapter A, 1973 rev. 2014)
Jointly administered by FWS and the Commerce Department's National Marine Fisheries Service.
Purpose is to protect and recover imperiled animal species and their ecosystems. All species of animals and plants are eligible for protection, except pest insects.
Prohibits any action, administrative or real, that results in the taking of a listed species or adversely affects the habitat of the listed species. Prohibits import, export, and interstate and foreign commerce of listed species and implements US participation in CITES. A federal permit is required to use listed species for scientific purposes.
162
What is the definition of "take" in the Endangered Species Act?
"To harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect or attempt to engage in any such conduct."
163
Lacey Act (1900, amended in 1981 and 2008 Farm Bill [plant import])
Addresses trafficking in ILLEGAL wildlife, fish, or plants. Authorizes the FWS to regulate to import, export, transport, sale, receipt, acquisition, or purchase of fish, wildlife, or plants that may be injurious to humans or to the interests of horticulture, forestry, or US wildlife resources.
Also provides for enforcement of state, federal, American Indian tribal, and foreign conservation laws.
Requires that live wildlife be transported into the US under humane and healthful conditions and that all containers and packages containing wildlife be appropriately labeled when transported in interstate and foreign commerce.
164
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA, 40 CFR, Chapter 1, Subchapter E)
Enforced by the EPA.
Considers the potential adverse impact of pesticides on endangered species and their habitats, with the goal of protecting human health and the environment, before licensing the use of pesticides.
The EPA can issue emergency suspension of the use of certain pesticides or cancel or restrict their use if the environment of an endangered species will be adversely affected. The EPA is authorized to strengthen the pesticide registration process by shifting the burden of proof to the manufacturer.
FIFRA also provides federal control of pesticide distribution and sale and requires registration of users (farmers, utility companies, and other) and certification of applicators.
165
Animal Transportation Association (ATA)
Concerned with transportation of animals by sea, land, and air.
1. Facilitates international and domestic transportation of animals using the most expeditious and economic routes
2. Encourages making live animal cargo a priority for carriers and handlers
3. Encourages the establishment of an animal protection office at principal ports and terminal where live animals are handled that will oversee adequate protection and humane handling of live animal shipments
4. Encourages research on all phases of animal transportation
166
Live Animals and Perishables Board (LAPB)
Coordinated by the International Air Transport Association (IATA). Objectives are:
1. Adoption of regulations for the acceptance, handling, and loading of live animals in air transport
2. Promotion of public awareness and government acceptance of the Live Animals Regulations
3. Providing an open forum for member airlines to exchange and develop information specific to the transport of live animals and perishables
4. Promote an open dialogue with civil aviation authorities and shipping industry
167
Live Animals Regulations
Published by the International Air Transport Association (IATA).
The global standard for transporting animals by commercial airlines. Addresses the container specification and other transportation requirements for numerous species.
Has a cooperation agreement with OIE to enhance veterinary research into animal health during air transport, the development and revision or international standards for air transport of live animals and perishable goods such as biological samples as well as the technical requirements for their international transport.
168
Occupational Safety and Health Act (CFR 1970, revised 2013)
Administered and enforced by the Department of Labor and the Occupational Safety and Health Administration (OSHA).
Intent is to provide workers with protection against illnesses or injury resulting from unsafe or unsanitary working condition.
The act established the National Institute for Occupational Safety and Health (NIOSH), within the CDC.
169
National Institute for Occupational Safety and Health (NIOSH)
Within the CDC. Plans, directs, and coordinates national programs to develop and establish recommended occupational safety and health standards (29 CFR, Part 1910) and to conduct research, training, and related activities to assure safe and healthful working conditions.
Standards address bloodborne pathogens, respiratory protection, occupational noise exposure, hazard communication, and other relevant safety measures.
170
Drug Enforcement Act (PL-93-205)
The DEA of the Department of Justice is responsible for enforcing this act.
Requires appropriate security and record management of controlled substances that are considered to be potentially addictive or habituating for human and animal use.
171
Atomic Energy Act (1954)
Authorizes the Nuclear Regulatory Commission (NRC) to help ensure that civilian use of radioactive materials is conducted in a manner consistent with public health and safety, environmental quality, national security, and antitrust laws.
In 1974, the NRC became an independent regulatory agency under the provision of the Energy Reorganization Act.
172
Nuclear Regulatory Commission (NRC)
Licenses individuals and institutions that use radioactive material and regulates the procurement, use, storage, and disposal of these materials; the facilities, instruments, and equipment used for handling and storing radioactive materials must also meet NRC requirements. Personnel must be provided training in the safe handling and use of ionizing radiation.
173
Radiation Control for Health and Safety Act (1968)
Authorizes the FDA, through the Center for Devices and Radiological Health, to regulate the use of products that produce radiation, such as medical diagnostic imaging equipment, irradiators, and electron microscopes.
174
Safe Medical Devices Act (1990)
Updated monitoring of medical devices to required post-market surveillance, and authorizes the FDA to recall devices.
175
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
Published by the NIH/Office of Biotechnology Activities.
Apply to any research conducted at or sponsored by an institution that receives ANY of its support from the NIH. If an institution is receiving NIH funding for only research with synthetic nucleic acids, and that research is covered under the amended NIH Guidelines, any research with synthetic nucleic acids or recombinant DNA conducted at the instutition, REGARDLESS OF FUNDING SOURCE, will need to comply with all requirements of the NIH Guidelines.
176
What is the definition of recombinant and synthetic nucleic acid molecules?
1. Molecules that (a) are constructed by joining nucleic acid molecules, and (b) can replicate in a living cell (i.e., recombinant nucleic acids); 2. nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (synthetic nucleic acids); or 3. molecules that result from the replication of those described in 1. and 2.
177
Describe what transgenic animal work is covered by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.
1. Creation (breeding) of transgenic animals
2. Transgenic rodent colonies are ABSL2 level or higher
These cases require Institutional Biosafety Committee (IBC) registration.
178
What transgenic animal work is exempt from the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules?
Maintenance (NOT breeding) of transgenic rodent colonies at ABSL1.
179
General Safe Practices for Working with Engineered Nanomaterials in Research Laboratories (NIOSH, 2012)
Describes occupational health and safety practices that should be followed during the synthesis, characterization, and research with engineered nanomaterials in the laboratory environment.
Key elements include: risk management, hazard identification, exposure assessment, exposure control, and control verification.
