BTEC 3317 EXAM 1

What is the best definition of biotechnology?

The use of technology to improve organisms or their products for the benefit of man

In the first generation of plants that were engineered to be resistant to viruses, one major concern is that:

 

New virus strains may arise that could infect new plant host

Vaccines against many diseases have been successfully produced in plants. Which of these diseases causes diarrhea, vomiting, dehydration, and death in hundreds of thousands of infants annually worldwide?

Rotavirus

The AquaAdvantage salmon was genetically engineered to be much faster growing than the native salmon counterpart. What could be a concern with having the engineered faster growing salmon?

Loss of gene pool for resistance to a new viral pathogen of salmon

ATryn is an anti-blood clotting human protein produced in goats. What is a major concern whenever therapeutic human proteins are produced in animals

 

Risk of contamination of the drug product by animal viruses that could infect humanS

What is not a risk encountered in pre-natal diagnostic testing by amniocentesis

Promotes cancer in the mother

What is one reason as to why earlier gene therapy clinical trials in humans had to be stopped by the Food and Drug Administration?

The inserted gene caused the activation of a cancer causing gene in several patient

Which of these products are from classical biotechnology and not from recombinant or modern biotechnology?

Anti-COV2 antibodies purified from the blood of a previously infected person

Which is not a major concern with xenotransplantation, or the use of animal organs in humans?

Some animal organs contain unhealthy levels of cholesterol

What is true of endotoxins?

 Not a main concern if the drug contaminant is a Gram positive bacteriA

Which of these drugs, that can be produced using microbes, is used to stimulate production of red blood cells in patients with anemia, but is also a banned performance enhancing drug for athletes?

Erythropoietin

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?

The cell cultures that churn out the therapeutic protein got contaminated with a virus

The first genetically modified microorganism that was granted a patent was used in bioremediation to:

Facilitate the degradation of crude oil components

What was a regulatory concern with FlavRSavR tomato?

The recombinant gene was introduced into tomato using the normally plant pathogenic, Agrobacterium tumefaciens

Plants that produce the insecticidal Bt or cry toxin have also been engineered to kill different types of caterpillars. What initially was the main concern with transgenic plants producing the cry toxin?

Useful insects that feed on the transgenic crops may get killed

What is not true of laws or regulations?

 Laws are enforceable while compliance with regulations is voluntary

In which website would you find the most recently drafted Congressional bill on the possible ban on the use of RoundUp as a herbicide and be allowed as a consumer to submit comments before the bill is approved?

Federal Register

In 1971, Paul Berg successfully combined E. coli DNA with 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.

Recombinant DNA Advisory Committee (RAC)

Transfer of genetic material from microbes to taxonomically unrelated organisms occur in the laboratory under artificial conditions.  There are also some genetic transfer that takes place in nature outside of the controlled conditions in a laboratory.

True

Current regulations on recombinant DNA activities apply to federally-funded research and also to private industries even if they do not receive federal funding

True

As part of containment guidelines for naturally occurring and genetically modified microbes, NIH classified microbes to biosafety levels according to their risks to even healthy individuals. For which microbe BSL classification will personal protective equipment, like head-to-toe coverall and self-contained breathing apparatus be most likely to be required?

BSL - 4

What does not apply to the CFRB and CFRB policies?

CFRB stands for Centralized Framework for the Regulation of Biotechnology

With the publication in 1986 of the Coordinated Framework for the Regulation of Biotechnology (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 most likely be considered intergeneric?

Engineering of a yeast gene into corn to improve biofuel production

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

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 transgenic plant from mainland US into mainland China

What is true of the Animal and Plant Health Inspection Services' (APHIS) permit system for GMO testing?

 Permit must be submitted 120 days before planned GMO field testing

What is currently the law primarily used by the US Department of Agriculture to regulate genetically engineered plants and which requires a permit prior to field testing of GMOs?

 

None of the other choices is correct (plant protection act)

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.

 Petition:non-regulated

The development of a marketed GM plant takes around 9 years. The regulatory responsibilities of USDA begins with:

Initial field trials

What is not a 2013 goal of the Advisory Committee on Biotechnology 21st Century Agriculture (AC21)?

Help quantify financial losses of farmers due to calamities such as Hurricane Harvey

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?

 In 2023, DDT was the most widely used agricultural pesticide in the US

The EPA's reason for regulating herbicide resistant plants is due mainly to:

 the herbicide-resistance gene may be passed on to difficult-to-control weeds

The US Environmental Protection Agency is responsible for regulating pesticides, novel microorganisms, and herbicide resistant plants under CFR title _______.

CFR 40

The EPA requirements for pesticide registration and for Experimental Use Permits before testing bioengineered plants or microbes in the environment is covered under the Federal Fungicide and Rodenticide Act (FIFRA). Under FIFRA, what is or are regulated by the EPA in a transgenic plant expressing a plant-incorporated protectant?

  The transgene and the protein translated from the transgene

Management of insect resistance to plant-incorporated pesticides (PIPs) is one responsibility of EPA. What is a practice recommended to delay the development of insect resistance to PIPs?

 Maintain refuges with plants that will allow feeding and breeding of the target insect

Registration refers to federal pre-marketing approval of biopesticides. What would not be regulated by U.S. Environmental Protection Agency as a biopesticide?

 Chicken vaccines against Salmonella

What is not true of EPA’s experimental use permit?

 An EUP is required for laboratory or greenhouse tests of new microbes

The first Experimental Use Permit (EUP) issued in 1985 by EPA 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?

 The genetically engineered ice minus microbe was applied to plants within a 20 acre land area

Which Act is used mainly by the EPA to regulate new microbes that may be used for bioremediation, petroleum degradation, or disease control (ina-)?

Toxic Substances Control Act

The Resource Conservation and Recovery Act:

equired that hazardous waste be incinerated

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.

FALSE

Which federal agency is primarily responsible for enforcing regulations designed to protect biotech workers from possible hazards of exposure to pharmaceutical wastes?

 

Occupational Safety and Health Administration

Patents protect inventions for up to 20 years from the earliest date of filing. For rice genetically engineered to produce high levels of b-carotene in the grains, intellectual property protection activity starts at what stage of product development?

 Starting from isolation and construction of the b-carotene genes

Patents protect inventions for up to 20 years from earliest date of filing 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:

 Fetal cell –free DNA is a product of nature and cannot be patented

The first patent for a genetically engineered microbe was granted to Chakrabarty. The microbe is:

Pseudomonas putida for the breakdown of crude oil components

Which federal agency protects consumers by regulating business practices, such as false and deceptive advertising and company mergers which might be anti-competitive?

Federal Trade Commission

In section 402 of 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 _________ and section 409 covers regulations on __________, which are substances that are not a normal constituent of foods.

 

adulterated:misbranded:additives

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 level of pesticides in food that should not be exceeded

What is not true about foods that are classified as GRAS?

 The FDA have no authority to stop the distribution of a product classified as GRAS

What does not apply to GMO or non-GMO plants?

 recombinant DNA technology typically introduces many genes and gene products to the GMO plant

Choose the best answer. What is not true of a food additive?

Food additives that are introduced by genetic engineering are exempt from the requirement for FDA approval prior to marketing

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 direct allergenic potential of the recombinant DNA

FDA's health safety assessments of GE foods are based in part on the concept of ______________ to non-GE crops.

Substantial equivalence

After FDA’s assessment of bioengineered foods, what is the regulatory endpoint when the product is probably safe but FDA wants further tests to characterize the effect of the transgene on nutritional properties of the BE crop?

Consult further

In 2001, FDA required developers to submit a scientific and regulatory assessment of their new GE crop about ___________ before the bioengineered food is marketed.

4 months

____________________are submissions to FDA under the early food safety evaluation guidance of new non-pesticidal proteins produced by new plant varieties that are intended for food.

New protein consultations

The official FDA position is not to require labelling of GMO crops. What is one instance where the FDA might not require manufacturers to inform consumers that what they are marketing is made from a GMO?

 

When a gene from lettuce is engineered into soybeans used to make cooking oil

What is FDA's standard definition of bioengineered food?

Food that has been modified through rDNA techniques in a way that could not be obtained through conventional breeding or found in nature

Some transgenic plants that have been genetically engineered to have new traits, may actually not contain any foreign DNA in them.

TRUE

Which of these genetically-engineered food products might be required to be labelled as bioengineered?

Banana engineered to produce a hepatitis B vaccine

The New Animal Drug Application (NADA) for AquAdvantage was finally approved by the FDA in 2015 with several containment safeguards implemented. What is not one of the containment safeguards in relation to AquAdvantage?

 Biological containment by growing both male and female transgenic fishes in the US

What is the best definition of drug according to the FDA?

Drugs are for use in the prevention, diagnosis, mitigation, cure or treatment of disease in man

What does not apply to patent medicines?

Patent medicines are FDA-approved marketed drugs

What safety crisis led to the Biologics Control Act of 1902 which required manufacturers of biologics to be licensed and inspected annually?

 Death of children from a tetanus-contaminated antitoxin drug against diphtheria

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?

The safety of the preservatives were demonstrated in animals first prior to the testing in humans

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 and still in use today? For the long exam, you will need to know all preservatives which are still used today and those that are now banned,

Benzoate

The legal term for changes or additions to existing laws are referred to as amendments. Which amendment to the Pure Food and Drug Act banned false therapeutic claims on labels that are intended to defraud users of drugs?

Sherley Amendment

What does not have much to do with the Federal Food Drugs and Cosmetic Act of 1938?

requirement that a new drug be demonstrated as effective prior to marketing approval

In 1941, there were deaths from sulfathiazole antibiotic tablets that got contaminated with the sedative and epilepsy drug, phenobarbital. As a result, the FDA introduced quality controls leading to the development of:

Good manufacturing practices

Which of the following is least relevant to the Kefauver-Harris Amendments of 1962?

Patent medicines with unknown ingredients

In the Fair Packaging and Labeling Act of 1966, what information is not required on drug labels or packages?

Manufacturer of ink used on the label

The death from 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?

 The tamper-evident drug container should be made of unbreakable, amber-colored plastic bottles

What is not true of the Hatch-Waxman Act of 1984?

Larger clinical trials than that done for testing the branded drug, are required for marketing approval of the copycat drugs

FDA's primary response to the urgent need of patients for another effective drug against AIDS was to allow the use of non-sterile drug products

FALSE

What Act allowed FDA to collect monies from drug manufacturers so as to hire more FDA reviewers, thus shortening the time for new drug marketing review and approval?

Prescription Drug Users Fee Act of 1992

What is of least relevance to the Drug Quality and Security Act of 2013?

Illegal practice of sale of drug samples given to physicians