Additional regs and guidelines Flashcards
(119 cards)
1
Q
Who published the 2020 Ag Guide?
A
1) American Diary Science Association
2) American Society of Animal Science
3) Poultry Science Association.
2
Q
IACUC members for AWA, Guide, Ag Guide, and PHS policy
A
AWA: 3 (vet, scientist, unaffiliated)
Guide: 4 (vet, scientist, nonscientist, unaffiliated)
Ag Guide: 5 (vet, scientist, ag scientist, nonscientist, unaffiliated)
PHS: 5 (vet, scientist, nonscientist, unaffiliated)
3
Q
Per Ag Guide, for occupational health tetanus vaccine should be given every ___ years
A
10
4
Q
Per Ag Guide, for the disposition of GE animals and clones it is recommended that institutions and researchers participate in the _____, whereby animal clones are registered in the database or registry.
A
Livestock Industry Clone Registry
5
Q
Per Ag Guide, must keep records of drugs and potentially harmful substance for ___.
A
3 months
6
Q
What does FARAD stand for?
A
Food Animal Residue Avoidance Databank
7
Q
Extralabel drug use permitted only when adheres to the ____ 1994 Public Law
A
Animal Medicinal Drug Use Animal Medicinal Drug Use Clarification Act (AMDUCA)
8
Q
According to AMDUCA what 5 things are needed for extralabel drug use?
A
- Veterinary-client-patient relationship
- Extra label drug use in feed is illegal
- Drug must be manufactured in an FDA-inspected facility
- Maintain records for 2 years
- Follow withdrawal times
9
Q
In accordance with the US Code of Federal Regulations [9 CFR], water is to be accessible to livestock at all times in holding pens, and feed is to be accessible after livestock have been held longer than ___ h.
A
24
10
Q
According to Ag Guide, for very young animals air speed (drafts) should be < ____
A
0.25 m/s (50 ft/min)
11
Q
ALL ag animals are social with the exception of ____.
A
the adult boar
12
Q
What color may make poultry more docile?
A
BLUE
13
Q
Beef cattle are ____ raised, while dairy cattle are ___ raised. How does this affect flight zones?
A
Extrinsic = larger flight zones
Intrinsic (more confined, need to provide food/water)
14
Q
Panepinto sling to restrain smaller pigs up to ____ lbs
A
350
15
Q
____ refers to a holding area, typically at a slaughterhouse, where animals are kept before slaughter
A
Lairage
16
Q
For dehorning of beef cattle, remove within ____ month. If beyond that age, use local anesthesia.
A
1 month
17
Q
Because cows prefer to stand uphill, the stall base for dairy cattle should be sloped forward ____%
A
4%
18
Q
The low critical temp of the piglet is ____ at birth
A
95F
19
Q
To castrate boars, perform before ____. If beyond that age use local anesthesia.
A
14 days
20
Q
When trimming needle teeth (canines) in young pigs, perform before 3 days old and do not remove more than ___ of tooth.
A
1/2
21
Q
Recommended illumination for sheep and goats
A
220 lux
22
Q
Ideally castrate small ruminants before ___. If castration done >____ of age, considered major surgery and requires use of analgesia/anesthesia
A
7 days
3 months
23
Q
For sheep, tail-docking should be done before ____ of age, after that time use local anesthesia.
A
2 weeks
24
Q
There are 3 commonly accepted methods for castrating rams and bucks:
A
(1) application of rubber rings
(2) crushing the spermatic cord with an emasculator (the Burdizzo method)
(3) surgical removal of the testicles.
25
Ideally dehorn small ruminants before ____ of age.
1 month
26
What is the preferred air temperature for housing neonatal 3-15 kg swine (pre-nursery) according to Ag Guide?
79-90F
27
What flooring is NOT recommended for swine?
Seamless epoxy (slippery, cracks, not readily disinfected)
28
Pesticides should only be used in animal areas following approval by or consultation with the _____?
Investigator
29
According to the Guide for the Care and Use of Agricultural Animals in Research and Teaching, which of these pollutant gases is of least concern in animal facilities?
a. Ammonia
b. Hydrogen sulfide
c. Carbon monoxide
d. Methane
e. NO2
NO2 (The rest have exposure limits)
30
Limits for ammonia, hydrogen sulfide, carbon monoxide, methane per Ag Guide
Ammonia – 25 ppm
Hydrogen sulfide – 50 ppm
Carbon monoxide – 150 ppm
Methane – 50,000 ppm
31
Facilities must use biosafety containment level-3-Agriculture (BSL-3-Ag) under what situation?
When animals are loosely housed and room must become the primary barrier
32
Space requirements for market-size cattle, swine, and sheep at lairage (holding space before slaughter)
20, 6, and 5 sq ft respectively
33
According to Ag Guide, what temperature for neonatal poults (turkeys)?
95-100F
34
According to the Guide for the Care and Use of Agricultural Animals in Research and Teaching, who has responsibility for oversight of medical records?
AV and IACUC
35
What discouraged practice removes wool-bearing skin of sheep around hind end to prevent fly strike?
Mulesing
36
What procedure in sheep is commonly performed prior to parturition to minimize fetal contamination during the birthing process?
Crutching
37
Dubbing refers to which standard agricultural practices?
Partial removal of the comb of chickens - but it's important for thermoregulation so need to make sure they stay cool
38
Weanling pigs are commonly vaccinated for ___ and ___.
erysipelas
leptospirosis
39
Temp for brooding in young chicks, poults, and ducklings
90-95F
40
Agricultural scientists can be certified
through examination by the ____.
American Registry of Professional Animal Scientists (ARPAS)
41
What is considered the de facto standard for classifying thermal environments?
THI (temperature-humidity index)
42
Maceration in poultry up to ____ old
72 hours
43
IACUC membership per Ag Guide
5 members
1) Scientist with experience in agricultural research
2) Animal, dairy, or poultry scientist
3) veterinarian with training and experience in agricultural animal medicine
4) non-scientist
5) unaffiliated
44
Recommended enrichment for poultry
Perches, nest boxes, nesting substrate, foraging, dust baths
45
How to determine acclimation period for metabolism stalls?
No recommended preconditioning period; IACUC decides
46
According to the “Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching,” cold housing systems usually provide animals with a microenvironmental temperature that is no more than how many degrees above the outdoor temperature?
5C
47
What CFR and Subpart is ***FDA*** GLP?
CFR 21 Subpart 58
48
Per GLP guidelines, what describes in vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their ***SAFETY***?
Nonclinical laboratory study
49
Per GLP guidelines, what describes a person who actually conducts a nonclinical laboratory study, i.e., actually uses the test article in a test system?
Testing facility
50
Per GLP guidelines, what term describes the individual responsible for the overall conduct of a nonclinical laboratory study?
Study director. They sign the study initiation and completion date
51
Per GLP guidelines, who maintains a copy of a master schedule sheet of all nonclinical laboratory studies conducted at the testing facility?
Quality Assurance Unit
52
The statement of GLP study results should be prepared by ____ and then final report signed by ____.
Quality Assurance Unit
Study director
53
How long to keep records for GLP studies?
- 2 years after ***application*** is approved by FDA
- 5 years after ***results*** are submitted to FDA
- If not submitted: 2 years after study is completed, terminated, or discontinued
54
Who oversees oversees disqualification of a GLP testing facility that is out of compliance?
The Commissioner of the FDA. Even if disqualified, still need to submit study results to the FDA.
55
If a sponsor terminates or suspends a GLP testing facility from further participation in a nonclinical laboratory study that is being conducted as part of any application for a research or marketing permit that has been submitted to any Center of the FDA (whether approved or not), it shall notify that Center in writing within ___ working days of the action.
15
56
What is a sponsor for GLP?
(1) A person who initiates and supports a nonclinical laboratory study;
(2) A person who submits a nonclinical study to the FDA in support of an application for a research or marketing permit; or
(3) A testing facility, if it both initiates and actually conducts the study.
57
What CFR pertains to FDA?
21
58
What CFR and Subpart is ***EPA*** GLP?
***40 CFR - Part 160*** – Good Laboratory Practice -- Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)
***40 CFR - Part 792*** – Good Laboratory Practice -- Toxic Substances Control Act (TSCA)
59
What are two drug applications through FDA GLP?
(1) Investigational new drug application (IND) - yet to begin human clinical trials
(2) A new drug application (NDA) - completed human clinical trials and seeking to go on the market
60
What is a main difference between Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA) (EPA GLP)
While FIFRA calls for extensive test data as part of a complex registration process, TSCA requires only a 90-day advance notice to produce a new chemical.
61
What is study initiation date vs day 0?
Study initiation date: Study director signs off
Day 0: Test article is given
62
When FDA visits GLP facility, are Quality Assurance Unit findings and problems identified required to be shared?
No; they're excluded from requirements
63
According to FDA GLP do animals of different species need to be housed in different rooms?
Only when necessary
64
When is extralabel use of phenylbutazone prohibited in food animals?
Only prohibited in dairy cattle >20 months old
OK extralabel in small ruminants
65
When is extralabel use of sulfonamides prohibited in food animals?
In lactating dairy cattle (Except approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine)
OK extralabel in small ruminants
66
What drugs are prohibited for extralabel use in food animals?
Chloramphenicol, clenbuterol, diethylstilbestrol (DES), nitroimidazoles, sulfonamides in lactating dairy cattle (except approved ones - sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine), fluoroquinolones, glycopeptide abx (eg vancomycin), Phenylbutazone in female dairy cattle 20 months of age or older, cephalosporins (Except cephapirin) in cattle, swine, chickens, or turkeys
67
Can the FDA grant marketing approval for a new drug product if if only one species is used for preclinical testing?
Yes; if that one species is sufficiently well-characterized animal model to predict the response in humans
68
Which Federal law gives the Fish and Wildlife Service authority to regulate and enforce the importation, exportation, transportation and sale of fish, wildlife or plants that may be injurious to humans or US wildlife?
Lacey Act
69
Are animal cage cards that contain only animal ID, study number, study dates and cage number considered to be raw data for a nonclinical laboratory study submitted to the Food and Drug Administration?
No
70
Which CFR specifically addresses the importation of live nonhuman primates?
42 CFR Subpart 71
71
Which CFR specifically addresses HHS, CDC select agents and toxins?
42 CFR Subpart 73
72
What CFR is the Controlled Substances Act from the DEA?
CFR 21 (same as FDA GLP)
73
DEA Form 222 = ___
DEA Form 224 = ___
DEA Form 225 = ___
Class 1 or 2 order form
Institution, Practitioner
Researcher
74
Schedule 1 controlled Substances must be in a Class ____ security container
5
75
How long to maintain records for DEA (Controlled Substances Act)?
2 years
76
How often to conduct inventory for DEA?
Every 2 years
77
Significant loss must be reported to the DEA within ___ business days.
1
78
High potential for Abuse, No currently accepted medical use = DEA Schedule ___
1
79
High potential abuse, may lead to ***severe*** psychological or physical dependence = DEA Schedule ___
2
80
Potential for abuse but less than lower schedules, may lead to moderate or low physical dependence or ***HIGH psychological dependence***
= DEA Schedule ___
3
81
Low potential for abuse, Limited physical or psychological dependence relative to drugs and other substances = DEA Schedule ___
4
82
Lowest potential for abuse = DEA Schedule ___
5
83
DEA Schedule 1 examples
Heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote, methaqualone and 3,4-methylenedioxymethamphetamine ("extasy")
84
DEA Schedule 2 examples
NARCOTICS: Morphine, opium, hydromorphone (Dilaudid), methadone (Dolophine), Meperidine (Demerol), oxycodone (OxyContin), fentanyl (Sublimaze or Duragesic)
STIMULANTS: Amphetamine (Dexedrine, Adderall), methamphetamine (Desoxyn) and methylphenidate (Ritalin)
Other: Cocaine, amobarbital, glutethimide, and ***pentobarbital (Nembutal)***, Hydrocodone, codeine
Alfentanil, sufentanil, carfentanil
85
DEA Schedule 3 examples
Combination products: 15 mg of hydrocodone per dosage unit (Vicodin), 90 mg or less of codeine per dosage unit (Tylenol w/ codeine)
***Buprenorphine*** (Buprenex, Temgesic, Suboxone, Subutex)
NON-Narcotics: Benzphetamine (Didrex), phendimetrazine, ***tiletamine and zolazepam (Telazol)***, ***ketamine***, thiopental (pentothal), Pentobarbital and phenytoin (Beuthanasia/Euthasol), anabolic steroids (Oxadrin), nalorphine (mixed agonist/antagonist like torb but stronger)
86
DEA Schedule 4 examples
Narcotic: propoxyphene (Darvon and Darvocet-N 100) = weak opioid agonist
Alprazolam (xanax), clonazepam (Klonopin), clorazepate (Tranxene), ***diazepam (Valium)***, lorazepam (Ativan), ***midazolam (Versed)***, temazepam (Restoril) and tiazolam (Halcion), ***butorphanol (Torbugesic)***, chloral hydrate (Noctec), tramadol, and ***phenobarbital***
87
DEA Schedule 5 examples
Used commonly for antitussive, antidiarrheal, and analgesic purposes:
Cough preparations containing <200 mg of codeine per 100 mL (Robitussin AC and Phenegran w/ Codeine), Diphenoxylate (Lomotil)
88
What TWO conventions that govern international manufacture, use and distribution of controlled substances were from the Vienna Convention? Who governs these two treaties?
1961 Single Convention on Narcotic Drugs
1971 Convention on Psychotropic Substances
These two treaties are governed by WHO
89
What department contains DEA?
Department of Justice
90
The CSA is administered by ___ and enforced by the ___.
The Secretary of Health and Human Services
DEA
91
When does veterinarian report to the controlled substance reporting system (CSRS)?
When sending schedule drug home with patient
92
Schedule I and II controlled substances may be transferred to another user who is authorized to use such drugs via the DEA form ___
222
93
What DEA Schedule is tramadol?
IV
94
What DEA Schedule is phenobarbital?
IV
95
What DEA Schedule is lysergic acid diethylamide?
LSD - I
96
What DEA schedule is Vicodin (hydrocodone and acetaminophen)?
III
97
What DEA schedule is methaqualone?
I (a recreational drug)
98
What DEA schedule is oxycodone (OxyContin)?
II
99
What DEA schedule is benzphetamine (Didrex)?
III
100
What DEA schedule is pentobarbital (Nembutal)?
II
101
What DEA schedule is amphetamines (Dexedrine, Adderall)?
II
102
What DEA schedule is propoxyphene (Darvon, Darvocet-N 100)?
IV
103
What DEA schedule is methcathinone (MCAT)?
I
104
What DEA schedule is clonazepam (Klonopin)?
IV
105
What DEA schedule is hydromorphone (Dilaudid)?
II
106
What DEA schedule is amobarbital?
II
107
What DEA schedule is cocaine?
II
108
What DEA schedule is methylphenidate (Ritalin)?
II
109
What DEA schedule is oxandrolone (Oxadrin)?
III (anabolic steroid)
110
What DEA schedule is meperidine (Demerol)?
II
111
What DEA schedule is phenytoin (Beuthanasia/Euthasol)?
III
112
What DEA schedule is methamphetamine (Desoxyn)?
II
113
What DEA schedule is lorazepam (Ativan)?
IV
114
What is excluded from Endangered Species Act/CITES?
1. Specimens in transit or being shipped
2. Specimens acquired before CITES applied to them
3. Personal or household effects
4. Bred in captivity – FWS regulates
5. Plants that were artificially propagated
6. Destined for scientific research
7. Part of travelling collection or exhibition
115
What CITES appendix is Ambystoma americana and poisoned dart frogs?
Axolotl
Both CITES II
116
Which NHPs are all CITES II?
Papio spp, Aotus spp, Chlorocebus spp
117
All NHPs are within CITES...
I or II
118
What United States government agency is responsible for enforcement of the Convention on the International Trade of Endangered Species of Wild Flora and Fauna?
US Fish and Wildlife Service within Dep of Interior
119
What does the acronym CITES mean?
Convention on International Trade of Endangered Species of Wild Fauna and Flora
