BTEC 3317 Test 1
The requirement for pesticide registration and for Experimental Use Permits before testing bioengineered plants or microbes in the environment is covered under which Act? Animal and Plant Health Inspection Act Federal Insecticide Fungicide and Rodenticide Act Federal Food Drugs and Cosmetic Act Toxic Substances Control Act National Environmental Protection Act
Federal Insecticide Fungicide and Rodenticide Act
"What is the daily official publication of the US government where all newly proposed and final federal rulemaking (including regulations) can be accessed, and where the public can comment on proposed laws?" Federal Register Library of Congress electronic Code of Federal Regulations Public law International Conference on Harmonization
Federal Register
Which federal agency bans monopolies by drug companies that could lead to inflated drug prices? Federal Trade Commission Securities and Exchange Commission Occupational Safety and Health Administration U.S. Patent and Trademark Office Drug Enforcement Administration
Federal Trade Commission
What is of least relevance to the Drug Quality and Security Act of 2013? Implementation of electronic and interoperable system to track certain prescription drugs in the U.S Outbreak of fungal meningitis due to a contaminated steroid used for back pain Required registration of companies that mix custom medications from bulk drug suppliers Illegal sale of drug samples given to physicians Failure to properly sterilize drugs and failure to test sterility of marketed drugs
Illegal sale of drug samples given to physicians
Dr. Harvey Wiley's "clinical trials" with the poison squad tested the toxic effects of food preservatives and led to the Pure Foods and Drug Act of 1906. What was not true of that particular clinical trial? "No carcinogenic, mutagenic, or teratogenic studies were done prior to testing in humans" "The trial participants were volunteers, not prison inmates" Informed consent forms describing possible bad effects on participants health were signed prior to trial commencement There was no untreated control group for comparison with the group that was given the preservatives No animal safety studies of the preservatives were done prior to the testing in humans
Informed consent forms describing possible bad effects on participants health were signed prior to trial commencement
"In 1941, there were deaths from the use of sulfathiazole antibiotic that got contaminated with the sedative and epilepsy drug ____________. As a result, the FDA introduced quality controls leading to the development of good manufacturing practices." Kenandbarbidal Ritalin Acetaminophen Vioxx Phenobarbital
Phenobarbital
The New Animal Drug Application (NADA) for AquAdvantage was finally approved by the FDA in 2016 with several containment safeguards implemented. What is not one of the containment safeguards in relation to AquAdvantage? Geographical containment by breeding Aquadvantage outside of the US only "Genetic use restriction technologies (GURT) by raising only sterile, triploid fish in the US" Physical containment by placing nettings over the Aquadvantage tanks to minimize chance of their escape Genetic use restriction technologies (GURT) by raising only female transgenic fish in the US Physical containment by growing Aquadvantage in net pens in open water.
Physical containment by growing Aquadvantage in net pens in open water.
"What law is used by the US Department of Agriculture to hold, seize, quarantine or destroy genetically engineered plants which are being tested, used, or marketed, in violation of regulations?" Plant Health Act Recombinant DNA Advisory Act Plant Pest Act "Virus, Serum Toxin Act (VSTA)" Plant Protection Act
Plant Protection Act
"Which is not a major concern with xenotransplantation, or the use of animal organs in humans?" Possible carry over of bacterial pathogens from the donor animal into the human recipient Possible carry over of excess erythropoeitin from the animal to human The transplanted animal organ is likely to get rejected by the human recipient's immune system Receiving an animal organ or tissue maybe against one's religious beliefs Possible carry over of viral pathogens from the donor animal into the human recipient
Possible carry over of excess erythropoeitin from the animal to human
The first EUP issued in 1985 was for testing of two genetically altered ice-nucleation minus strains of naturally occurring Pseudomonas syringae that could protect strawberry from frost damage. What is not a precaution that was implemented during the field testing of the bacteria? An EPA observer was present during the experimental application. The applicators or technicians wore protective clothing from head to toe GE microbe was applied to plants within a 0.2 acre land area Test plot was surrounded by a 15 meter wide bare soil buffer zone "Applicators applied the bacteria using hand-held, high pressure sprayers with nozzles "
"Applicators applied the bacteria using hand-held, high pressure sprayers with nozzles "
"According to Code of Federal Regulations (CFR) title ___ part ____, a regulated article is any organism that has been altered through genetic engineering , if the donor, recipient, or vector agent belongs to a taxa considered as plant pest." "CFR7, part 340" "CFR70, part340" "CFR340, part7" "CFR21, part211" "CFR17, part340"
"CFR7, part 340"
"The environmental health mandate of the US EPA was motivated by a book by Rachel Carson entitled ""Silent Spring"" which talked about the negative environmental effects of a widely used agricultural chemical, DDT. What is not true of DDT?" DDT is a very effective insecticide against important crop pests DDT is very effective in controlling the incidence of mosquito-vectored diseases like the Zika virus DDT spraying contributed to the near extinction of many bird species DDT leads to bird eggs with thin shells which gets crushed when mother birds try to incubate them "In 2018, DDT was the most widely used agricultural pesticide in the US"
"In 2018, DDT was the most widely used agricultural pesticide in the US"
What was a regulatory concern with FlavRSavR tomato? "The plant pathogenic, Agrobacterium tumefaciens, was used to introduce the recombinant gene into tomato" The enzyme coded for by the engineered gene may interfere with digestion in humans "The human pathogenic bacterium, E. coli, was used to introduce the recombinant DNA into tomato" The toxin coded for by the engineered gene may kill beneficial insects A plant pathogenic virus was used to introduce the recombinant DNA into tomato
"The plant pathogenic, Agrobacterium tumefaciens, was used to introduce the recombinant gene into tomato"
Registration refers to federal pre-marketing approval of biopesticides. What would not be regulated by U.S. Environmental Protection Agency as a biopesticide? A bacterial mutant strain that protects crops from frost damage by a pathogenic bacterial strain "The widely used synthetic mosquito repellent, DEET"' "The pesticide, Rotenone, which is extracted from the roots of some legumes" "The Gram negative bacterium, Pseudomonas fluorescens, for controlling fungal pathogens of plants" The Bacillus thuringiensis cry toxin genes that are engineered in agronomically important crops to protect against insects
"The widely used synthetic mosquito repellent, DEET"'
"With the publication in 1986 of the CFRB as the formal policy for regulating biotechnology activities and products, intergeneric organisms were classified as new organisms and regulated as potential pathogens. What type of DNA transfer would least likely be considered intergeneric?" "Transfer of growth hormone gene from a fast growing salmon into a native, slower-growing salmon" Transfer of bacterial gene into rice for beta carotene production "Transfer of the cry toxin gene from the Gram-positive bacterium, Bacillus thuringiensis, into corn" Transfer of herbicide resistance gene from Agrobacterium into tomato cells "Engineering of the chymosin gene of cows into the fungus, Aspergillus, for use in cheese making"
"Transfer of growth hormone gene from a fast growing salmon into a native, slower-growing salmon"
"In 2001, FDA required developers to submit a scientific and regulatory assessment of their new GE crop about ___________ before the bioengineered food is marketed." 1 yr 6 months 1 month 2 months 4 months
4 months
What is one reason as to why earlier gene therapy clinical trials in humans had to be stopped by the Food and Drug Administration? A patient acquired a viral infection from the viral vector used A clinical trial participant died from an intense immune response to the virus vector Some patients acquired a functional immune system A clinical trial participant died from massive and uncontrolled bleeding Some patients refused to sign informed consent statements
A clinical trial participant died from an intense immune response to the virus vector
What does not apply to endotoxins? A drug contaminant that causes high fever when administered intravenously A substance found in outer wall of Gram negative bacteria A drug contaminant that causes an out-of-control immune response in drugs that are formulated as syrups A drug impurity that causes a runaway immune response when administered intravenously Not a main concern if the drug contaminant is a Gram positive bacteria
A drug contaminant that causes an out-of-control immune response in drugs that are formulated as syrups
Choose the best answer. What is not true of a food additive? Food additives require pre-market approval by the FDA Additives can be introduced into a plant by genetic engineering "Preservatives, artificial colors, and flavors are considered additives" An additive is substance whose normal levels in food may have been increased by human intervention A substance normally present in food is not considered an additive
A substance normally present in food is not considered an additive
The Genzyme plant in Massachusetts produces biotherapeutic enzyme replacement for people with Gaucher's disease. The plant was shut down by the FDA at one point causing a drug shortage concern for many patients. What was the reason for the shut down? Glass pieces were found in the drug product FDA found evidence of poor documentation or record keeping A virus contaminant was found in their cell cultures Vials of the therapeutic protein were found contaminated with a simian virus FDA found unsanitary manufacturing conditions
A virus contaminant was found in their cell cultures
"Vaccines against many diseases have been successfully produced in plants. Vaccine against rotavirus which causes diarrhea, vomiting, dehydration, and death in hundreds of thousands of infants annually worldwide have been produced using which plant?" Cantaloupe Strawberry Bougainvillea Alfalfa Papaya
Alfalfa
What product is not under the regulatory jurisdiction of FDA's Center for Veterinary Medicine? Cattle and pig feed Veterinary devices Dog and cat food Flea and tick products for dogs Antibody drug for cancer in dogs
Antibody drug for cancer in dogs
What is not a major reason for the need to regulate biotechnology products and their development and manufacturing? To prevent unsafe drugs from entering the marketplace Safety of our food products can be compromised New biotech products may cause harm to the environment Assure job security for FDA employees Our food supply could be compromised
Assure job security for FDA employees
"The development of a marketed GM plant takes around 9 years. As part of the requirements for new plant varieties, what process is done to get rid of possible unwanted sequences from a vector (such as Agrobacterium) used in introducing the gene into the GE plant?" Irradiation with ultraviolet light Sterilization of the GE plant Deletion of unwanted sequences using CRISPR technology Backcrossing with the parental line Incineration of the test plants after field testing
Backcrossing with the parental line
Which of these genetically-engineered food products might be required to be labelled as bioengineered? Sugar from a sugar beets engineered with a virus resistant gene Wine produced from grapes engineered to be resistant to grape fan leaf virus Oil derived from corn engineered with a virus resistant gene Banana engineered to produce a hepatitis B vaccine Vinegar produced from sugarcane engineered to be resistant to a virus
Banana engineered to produce a hepatitis B vaccine
"Which legislation was precipitated by deaths due to the use of an anti-freeze ingredient in an elixir formulation of the antibiotic, sulfanilamide, and required that drugs be demonstrated as safe before marketing?" A. Drug Quality and Security Act 2013 . B. Prescription Drug Marketing Act of 1987 . C. "Food, Drug and Cosmetic Act of 1938 . " D. Hatch-Waxman Act 1984 . E. Drug Importation Act of 1848 .
C. "Food, Drug and Cosmetic Act of 1938 . "
" The US Environmental Protection Agency is responsible for regulating pesticides, novel microorganisms, and herbicide resistant plants under CFR title _______." CFR 172 CFR 7 CFR 21 CFR 40 CFR52
CFR 40
What does not apply to the CFRB and CFRB policies? CFRB policies are intended to ensure the safety of biotech research and products CFRB stands for Centralized Framework for the Regulation of Biotechnology A Pseudomonas strain engineered with a gene from Agrobacterium is considered to be a new organism "Intended to assign jurisdiction on regulation of biotech products to the FDA, EPA, and or USDA based largely on the intended use of the product" CFRB policies are based on verifiable scientific risks
CFRB stands for Centralized Framework for the Regulation of Biotechnology
Patents protect inventions in exchange for public disclosure of the invention. MaterniT21 was not granted a patent on the use of cell-free DNA for diagnosis of genetic disorders in a fetus because: Sequenom was not the first to file a patent claim on the use of cell-free DNA for pre-natal testing A specific utility for the technique was not provided in the application The technique was not convincingly described in the application Insufficient and dubious data were presented to support the patent claims Cell -free DNA is a product of nature and cannot be patented
Cell -free DNA is a product of nature and cannot be patented
What product is the US EPA not involved in regulating? Chicken vaccines against Salmonella Rat poisons Novel microorganisms Herbicide-resistant plants Biopesticides
Chicken vaccines against Salmonella
"The Biologics Control Act of 1902, which required the licensing and inspection of biologics manufacturers, resulted from death of children from a diphtheria antitoxin preparation that was:" Contaminated with simian virus Improperly sterilized Contaminated with glass pieces Prepared with an antifreeze solvent Contaminated with tetanus toxin
Contaminated with tetanus toxin
What is not a 2013 goal of the Advisory Committee on Biotechnology & 21st Century Agriculture (AC21)? Develop a thorough inventory of USDA data that would help to quantify economic losses incurred by farmers due to contamination of non-GMO products by GMOs Assess preventive techniques to minimize gene flow from GMO to non-GMO plants Evaluate the economic advantage of using organic vs inorganic fertilizers Gather data on unintended GE presence in commercial non-GE seed supplies intended for identity preserved production of non-GE plants "Evaluate the effectiveness of practices for coexistence of GMO, organic, and non-GMO crops."
Evaluate the economic advantage of using organic vs inorganic fertilizers
"The US Environmental Protection Agency is the lead federal agency involved in regulating the disposal of controlled, addicting drugs like heroin, other pain medications, anti-depressants and sleep aids." TRUE FALSE
FALSE
Transfer of genetic material from microbes to taxonomically unrelated organisms occur in the laboratory under artificial conditions; such transfer does not take place naturally outside of the controlled conditions in a laboratory. TRUE False
FALSE
The first genetically modified microorganism that was granted a patent was used in bioremediation to: Remove excess nitrogen from household sewage Facilitate the degradation of crude oil components Facilitate the degradation of bioethanol Remove excess phosphorus in sewage treatment plants For improved conversion of biomass to biofuels
Facilitate the degradation of crude oil components
What is not true of EPA's experimental use permit? Public comments are solicited before approval of the permit An EUP is not required for laboratory or greenhouse tests "An EUP will not be issued for testing in waters that affect fish, shellfish, or plants that are to be taken as food or feed" An EUP is not require if the field test is less than 10 acres of land Field testing of watermelon engineered with Bt is not required since Bt had been approved previously for use in corn.
Field testing of watermelon engineered with Bt is not required since Bt had been approved previously for use in corn.
What is not true about foods that are classified as GRAS? GRAS stands for Generally Recognized as Safe Safety of GRAS had been known based on long history of use in food "GRAS includes pepper, salt, vinegar, oil, spices and natural flavors" GRAS products are marketed after a thorough and formal review of its safe use by the FDA The FDA can stop the distribution of a product classified as GRAS
GRAS products are marketed after a thorough and formal review of its safe use by the FDA
What is not a risk encountered in pre-natal diagnostic testing by amniocentesis? Profuse bleeding Hyperimmune response by the fetus Fetal injury Faulty diagnosis leading to unnecessary abortion Miscarriage of the fetus
Hyperimmune response by the fetus
"The USDA requires a permit for the introduction of regulated organisms. Introduction is of three types. From the USDA regulations, which one is not included as a type of introduction?" Importation of a regulated organism from Japan and into the US Release of the regulated organism from a laboratory and into the environment for field testing Interstate transport of the regulated article from Texas to California Transport of regulated organism from Florida to Georgia Introduction of a transgene into a plant in one of the NSM laboratories
Introduction of a transgene into a plant in one of the NSM laboratories
The National Bionegineered Food Disclosure Law: "Is a state law, first enacted in Vermont, stating that GMO-containing produce do not need to have labels informing consumers of the presence of GMO in the produce" Is a state law that bans companies from selling GMO-containing food in Vermont and Connecticut Is a federal law that requires bioengineered produce to contain the letters GMO in their labels Is a federal law that allows the use of quick response codes to disclose the presence of GE material in food products Is a state law banning federal governments from requiring GMO labels on bioengineered produce
Is a federal law that allows the use of quick response codes to disclose the presence of GE material in food products
The AquaAdvantage salmon was genetically engineered to be much faster growing than the native salmon counterpart. What is the main concern why FDA took 19 years to approve its commercialization? It might outgrow and displace native salmon species It carries a virus that can kill the native salmon The nutritional content has changed significantly compared to the native salmon It might be capable of transmitting a virus to sushi chefs An antibiotic resistance gene is present in the recombinant DNA that was used
It might outgrow and displace native salmon species
What is not true of laws or regulations? Laws and regulations are both enforceable Laws are written or proposed by legislative bodies such as the congress or senate Regulations are written by federal agencies to provide details on how laws will be implemented by the agencies Failure to follow laws or regulations have legal consequences Laws and regulations are both found in the US Code
Laws and regulations are both found in the US Code
What is not true of the Prescription Drug Marketing Act of 1987? Samples of prescription drug products may be distributed only if a licensed prescriber requests them. Intended to reduce risks from misbranded or counterfeit drugs "required that prescription drugs manufactured in the US and exported, can no longer be reimported into the US, except by the product's manufacturers." Arose from concerns about illegal sale of excess pharmacy inventories Legislated due to lack of enough effective drugs for AIDS
Legislated due to lack of enough effective drugs for AIDS
"Human glucocebrosidase, for treatment of Gaucher's disease, has been successfully produced using carrot cells. What is a major advantage of producing biotherapeutics in plant vs in animal cells?" Less likelihood of contamination by animal viruses Proteins produced in plants have more similar glycosylation patterns to human proteins "More properly folded proteins, thus more active proteins using plant cell" Plant cells have added nutritional components compared to animal cells Plants cannot run away
Less likelihood of contamination by animal viruses
"Under the Toxic Substances Control Act, a manufacturer must submit a ___________________ 90 days before the manufacture or import of intergeneric microorganisms for commercial purposes" Intergeneric Microbes Exemption Commercial License Application for Novel Microbes Microbial Commercial Activity Notice Experimental use permit Notice for transgenic commerce
Microbial Commercial Activity Notice
"In the first generation of plants that were engineered to be resistant to viruses, one major concern is that:" There will be a viral epidemic The plant will become resistant to many viruses The plant may become drought sensitive More pathogenic virus strains could arise The plant will be resistant to only one virus
More pathogenic virus strains could arise
What does not apply to GMO or non-GMO plants? Non-genetically modified food crops do not contain toxins Many of today's food crops generated by mutagenic chemicals or radiation contain many uncharacterized mutations. Traditional selective breeding of plants for increased productivity is a form of genetic manipulation. recombinant DNA technology introduces well-defined traits to engineered plants recombinant DNA technology introduces 1 to a few known genes and gene products to engineered plants
Non-genetically modified food crops do not contain toxins
What does not apply to patent medicines? a. Patent medicines do not work for any type of ailment b. Many patent medicines were sold in travelling caravans c. Many patent medicines have inaccurate information on their labels d. "Patent medicines are also known as snake oil, cure alls, or miracle elixirs" e. Patent medicines are not FDA-approved drugs
Patent medicines do not work for any type of ailment
What is not true about the Animal and Plant Health Inspection Services' (APHIS) permit system for GMO testing? Required for a company before field testing of new GMO plant. APHIS must be notified within 24 hrs of accidental release of GMO Required for a UH Natural Science and Mathematics researcher before field testing of new GMO plant. Permit must be submitted 30 days before the planned field testing of the genetically engineered plant Precautions must be taken to prevent accidental spread of GMOs
Permit must be submitted 30 days before the planned field testing of the genetically engineered plant
"When a developer has collected enough evidence that a GE organism poses no more of a plant pest risk than an equivalent non-GE organism, the developer may _________ APHIS to determine ___________ status for the GE organism." Injunction:permit Petition:non-regulated permit:introduction Petition:introduction Permit:release
Petition:non-regulated
"In 1971, Paul Berg successfully combined with E. coli DNA the DNA from the virus, SV40, that causes cancer in apes. To address human health and environmental concerns with similar experiments in the future, the National Institutes of Health formed the ___________ in 1974. " Office of Science and Technology (OST) U.S. Department of Agriculture (USDA) Biotechnology Advisory Division (BAD) Food and Drug Administration (FDA) Recombinant DNA Advisory Committee (RAC)
Recombinant DNA Advisory Committee (RAC)
What anti-diabetic and anti-inflammatory drug was withdrawn from the global drug market because it causes liver dysfunction and failure? Rezulin Ritalin Prozac Vioxx Ephedrine
Rezulin
The Prescription Drug Users Fee Act of 1992 was passed mainly to: Force drug manufacturers to pay the FDA for their drug reviews Encourage the development of safer and more effective drugs Encourage the development of less expensive drugs Educate consumers as to the proper use of drugs Shorten the time for new drug review and marketing approval
Shorten the time for new drug review and marketing approval
"Patents protect inventions for up to 20 years from the earliest date of filing. For papaya genetically engineered to be resistant to the papaya ringspot virus, intellectual property protection activity starts at what stage of product development?" During backcrossing studies Before initial field trials of the GM papaya Starting from design of the gene construct for virus resistance Right after successful transfer of the resistance gene into papaya Right before marketing approval
Starting from design of the gene construct for virus resistance
What is not true of the Hatch-Waxman Act of 1984? Provided patent holders an extended term of protection from competition in the market place if there is delay in obtaining marketing approval Encouraged the manufacture and marketing of less expensive copies of branded drugs Large and expensive clinical trials are not required for marketing approval of the copycat drugs Generic drugs can be marketed only if the patent of the pioneer drug had expired Studies that show comparable bioavailability of the active ingredient in human subjects are waived
Studies that show comparable bioavailability of the active ingredient in human subjects are waived
FDA's health safety assessments of GE foods are based in part on the concept of ______________ to non-GE crops. Nutritional equivalence Horizontal gene transfer Nutritional superiority Substantial equivalence Adventitious presence
Substantial equivalence
What is not true of the Pure Food and Drug Act of 1906? The Act prohibited interstate commerce in adulterated drugs The Act prohibited false therapeutic claims on labels "The Act required listing of certain substances including cocaine, heroin, alcohol and morphine" The Act required labeling that is not false or misleading with respect to the contents of the drugs The Act did not require drugs to be both safe and efficacious .
The Act prohibited false therapeutic claims on labels
Plants that produce the insecticidal Bt or cry toxin have also been engineered to kill different types of leaf-chewing caterpillars. What initially was a concern with transgenic plants producing the Bt cry toxin? The Bt toxin can cause indigestion in humans The Bt toxin may kill the plant The Bt toxin may lead to herbicide resistant superweeds The Bt toxin may cause neurological disorders in humans The Bt toxin may kill bees that are required for pollination of certain flowers
The Bt toxin may kill bees that are required for pollination of certain flowers
"Under FIFRA, what is or are regulated by the EPA in a transgenic plant expressing a plant-incorporated protectant?" The GM plant only The transgene and the protective protein product of the transgene Only the foreign transgene introduced Only the protective protein translated from the introduced gene "The transgene, the protectant protein produced, and the transgenic plant are all regulated "
The GM plant only The transgene and the protective protein product of the transgene
"Using a gene found in bacteria, many agricultural crops in the US have been genetically modified to be resistant to the herbicide, RoundUp. What is a major concern with plants genetically engineered to be RoundUp resistant?" The RoundUp resistance gene can be passed on to and acquired by weeds. The RoundUp resistance gene can cause cancer in humans The RoundUp resistance gene can increase the plant susceptibility to insects The RoundUp resistance gene may increase disease incidence in plants The RoundUp resistance gene might kill pollinating bees
The RoundUp resistance gene can be passed on to and acquired by weeds.
"For evaluating transgenic plants, EPA spends about one year reviewing the data collected, prior to deregulating the plant for commercialization. What is not a concern that EPA focuses on?" The effects of the engineered protein on non-target insects or other animals The increased sugar content of the transgenic fruit Health effects of the bioengineered plant to humans upon consumption' Potential for transgene flow to undesirable weeds Source of gene and how it is expressed
The increased sugar content of the transgenic fruit
What is not true about the first product from a genetically engineered animal to be approved by the FDA? The rDNA introduced is not regulated as a drug because it does not affect the biological functions of the engineered animal The recombinant protein product is designed to inhibit blood clotting in patients deficient in the protein A functional human gene was knocked into a goat's genome The recombinant human protein is mainly expressed and produced in the mammary glands of the genetically-engineered animal The animal producing the human protein is considered a transgenic animal
The rDNA introduced is not regulated as a drug because it does not affect the biological functions of the engineered anima
"According to the FDA's 1992 policy, genetic engineering can change the composition of crops. What is a possible change in the composition of food that the FDA is least, or not concerned about?" The recombinant DNA might code for a protein that could catalyze increased production of a naturally occurring plant toxin A previously uncharacterized allergen might be inadvertently introduced with the rDNA The recombinant DNA itself might be directly toxic or allergenic The recombinant DNA might code for a protein that could modify naturally occurring compounds and generate new toxic substances The recombinant DNA might code for a protein that could change availability of nutrient levels in food because the protein may affect absorption or metabolism of nutrients.
The recombinant DNA itself might be directly toxic or allergenic
"One concern about the use of antibiotic resistance genes as markers for selection of successful transgenic events in plants, is that the resistance genes may be horizontally transferred which could mean that:" The resistance genes can be transferred to weedy plant varieties The resistance genes may be acquired by human cells lining the gut The resistance genes may be taken up by gut microbes that cause disease Antibiotic resistance protein can remain active in the gut and break down antibiotic that is being taken to treat an existing infection The ingested antibiotic resistance protein may be toxic or allergenic
The resistance genes may be taken up by gut microbes that cause disease
What is not true of laws? Proposed state laws don't need the approval and signature of the President of the United Sates before they can be implemented as laws Federal laws have power or precedent over contradictory state laws The successful passage of laws is not influenced by industries nor by public opinion Courts can block the implementation and enforcement of laws "Laws are alternatively referred to as statutes, Acts, or codes"
The successful passage of laws is not influenced by industries nor by public opinion
The death fro Children's Tylenol laced with cyanide led to certain requirements for tamper-evident packaging. What is not part of tamper-evident packaging requirement for over-the-counter (OTC) drugs as mandated in the Federal Anti-tampering Act of 1982? Tamper-evident package should be distinctive by design Tamper-evident device should be prominently displayed . Tamper-evident device should be identified on label . Device should provide clear and visible evidence if tampering has occurred . The tamper-evident drug container should be made of unbreakable, amber-colored bottles
The tamper-evident drug container should be made of unbreakable, amber-colored bottles
What is the best definition of biotechnology? The use of technology to improve man for the benefit of other organisms The use of technology to improve organisms or their products for the benefit of man The use of technology to improve organisms for their own benefit The use of genetic engineering to improve organisms The use of technology to improve humans for the benefit of plants
The use of technology to improve organisms or their products for the benefit of man
"With the publication in 1986 of the CFRB as the formal policy for regulating biotechnology activities and products, which agency or agencies will be involved in reviewing an ornamental palm tree genetically engineered to be resistant to a virus?" USDA and EPA only USDA only "USDA, EPA, and FDA" USDA and FDA only FDA and EPA only
USDA and EPA only
"In the Fair Packaging and Labeling Act of 1966, what information is not required on drug labels or packages? " a. Bureau of Custom's emergency hotline b. information on benefits and risks of the product c. identity of the product d. quantity of the product e. address of manufacturer
a. Bureau of Custom's emergency hotline
"In Section 402 of Federal Food Drugs and Cosmetic Act (FFDCA), foods that bear poisonous substances are referred to as ________, while in section 403, products where material information were omitted or inaccurate claims included are referred to as __________." adulterated:toxicants adulterated:misbranded toxicants:additives misbranded:toxicants misbranded:recombinants
adulterated:misbranded
Which of the following is least relevant to the Kefauver-Harris Amendments of 1962? a. "A very effective, morning sickness drug for pregnant women" b. Quinine that did not work in protecting against yellow fever c. Requirement for safety and efficacy before drug marketing approval d. "The anti-angiogenic drug, Thalidomide" e. Thousands of babies born with deformed limbs in Europe
b. Quinine that did not work in protecting against yellow fever
The Resource Conservation and Recovery Act: Regulated emissions of hazardous air pollutants like methanol and methylene chloride banned the disposal of hazardous waste in landfills Issued pretreatment standards for effluent discharge by companies Banned the incineration of flammable chemicals Issued limitations to effluent discharge by companies
banned the disposal of hazardous waste in landfills
"Harvey Wiley's "clinical trials" with the poison squad tested the toxic effects of food preservatives. Which of these still widely used preservatives was not banned under the Pure Food and Drug Act of 1906? For the long exam, you will need to know all 3 preservatives that are still in use today" a. Salicylic acid and salicylates . b. Formaldehyde . c. Boric acid and borax . d. Copper sulfate . e. Benzoate
e. Benzoate
"After FDA's assessment of bioengineered foods, a regulatory endpoint of ""No concerns"" would mean that:" the product is probably safe but the application is missing certain supporting information or data the GMO is approved for marketing because it is not much different in composition from the non-engineered counterpart "the GMO is not acceptable, perhaps due to detrimental effects to the environment" "the GMO is not approvable for marketing, perhaps due to some possibility that the bioengineered plant produces an allergen" "the GMO is not approvable for marketing, perhaps due to some possibility that the bioengineered plant produces a toxin"
the GMO is approved for marketing because it is not much different in composition from the non-engineered counterpart
FDA's Center for Food Safety and Applied Nutrition (CFSAN) is primarily responsible for the safety of biotech foods and enforces EPA's pesticide tolerances. What is the definition of pesticide tolerance with regards to FDA's regulatory responsibilities? the levels of pesticide that won't kill animals the level of pesticide that rats or mice can tolerate the level of pesticide that won't be toxic to farmers spraying them the amount of pesticide allowed to remain in food the level of pesticide that insect pests can tolerate
the amount of pesticide allowed to remain in food