BTEC 3317 Exam 1 (Quizzes 1-5)

What is the best definition of biotechnology?

-The use of technology to improve humans for the benefit of other organisms

-The use of technology to treat human maladies

-The use of technology to improve products for the benefit of man

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

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

Overweight babies

What is a concern about genetically engineered plants?

The newly introduced gene may code for a toxic or allergenic protein

What does not apply to endotoxins?

A drug contaminant that causes an out-of-control immune response in drugs that are administered orally

What does not apply to vaccines?

Vaccines are classified as products of classical biotechnology

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

Some animals will reject the presence of human organs

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

Newer and more aggressive virus strains may arise

"Which of these drugs that can be recombinatly-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

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?

The Bt toxin may kill beneficial insects

What was a regulatory concern with FlavRSavR tomato?

"The normally plant pathogenic, Agrobacterium tumefaciens, was used to introduce the recombinant gene into tomato"

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 clinical trial participant died from massive immune response to the virus that was used as vector to carry the functional gene

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 may lead to the extinction of native salmon species

What issue resulted from viral contamination of the cell cultures used by Genzyme to produce a biotherapeutic enzyme replacement for people with Gaucher's disease?

Concern about shortage of the drug for patients

"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

What is the main difference of modern from classical biotechnology?

Modern involves recombinant DNA technology while classical does not

"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 least likely be considered intergeneric?"

"Transfer of growth hormone gene from a fast growing salmon into a native, slower-growing salmon"

"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

"Say there is a proposed Congressional law which would require all genetically modified food products to be labelled with the letters GMO. As a well-informed biotech student, you are opposed to the bill since it could mislead the average consumer. In which law or lawmaking related site can you submit your comments before the bill is approved?"

Federal Register

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

TRUE

"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 ________________ formed the Recombinant DNA Advisory Committee (RAC) in 1974. "

National Institutes of Health

What is not true of laws or regulations?

Proposed state laws require approval by the President of the United Sates before they can be enforced

What is not true about the APHIS permit system for GMO testing?

APHIS must be notified within 3 days of accidental release of GMO

As part of containment guidelines for naturally occurring and genetically modified microbes, NIH classified microbes to biosafety levels (BSL) according to their risks to even healthy individuals. What is the BSL classification of the Ebola virus which can cause disease even in otherwise healthy individuals?

BSL-4

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

Initial field trials

"According to Code of Federal Regulations 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"

What does not apply to the CFRB and CFRB policies?

The intent of the CFRB is to assign jurisdiction on regulation of biotech products to either the FDA or USDA

"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 Protection Act

"Which genetically modified plant will most likely be regulated by the USDA and EPA, but not by the FDA?"

"A rose engineered to be resistant to powdery mildew, a type of fungus."

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

Evaluate the effect of an engineered protein on food digestibility in humans

One role of the US Department of Agriculture is to regulate the introduction of genetically engineered organisms that may compromise the health of agriculturally important plants or animals. What is not an example of introduction in the context of the previous statement?

Informing consumers of the new name for a GMO produce

"For soybeans genetically engineered with the cry or Bt toxin, intellectual property protection activity starts at what stage of product development?"

Starting from isolation and characterization of a new cry toxin gene

"Which law, enforced by the Environmental Protection Agency, seeks to issue pretreatment standards or requirements for industrial effluents?"

Clean Water Act 1972

"Which federal agency is primarily responsible for regulations concerning the proper disposal of pharmaceutical wastes consisting of controlled drugs like heroin, pain medications, and sleep aids?"

Drug Enforcement Administration

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

CFR 40

"The Resource Conservation and Recovery Act (RCRA), enforced by the EPA, regulates hazardous waste and bans their disposal in landfills. Under the RCRA, who has the initial responsibility for determining whether a company's wastes are classified as hazardous waste?"

the person or company that generated the waste

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?

Applicators applied the bacteria using high pressure hand-held sprayers with nozzles

What would not be regulated by U.S. Environmental Protection Agency as a biopesticide?

Pseudomonas putida that was the subject of the first patent for oil degradation

"Under the _______________________________ Act, intergeneric microorganisms used for R&D in contained structures are exempt from EPA reporting requirements, but only if researchers maintain records that support the eligibility for exemption"

Toxic Substances Control Act

"Under FIFRA, what is or are regulated by the EPA in a transgenic plant expressing a plant incorporated protectant?"

The transgene and the protective protein product of the transgene

The requirement for pesticide registration and for Experimental Use Permits before testing bioengineered plants or microbes in the environment is covered under which Act?

Federal Insecticide Fungicide and Rodenticide Act

What product is the US EPA not involved in regulating?

Vaccines to protect cows from anthrax

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

Incorrect

An EUP requires that all treated crops should be used as animal feed

Correct

An EUP is not required if field test is less than 10 acres of water

**I got it wrong but he still gave me the point, so I'm not sure exactly which one to use.

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

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

herbicide-resistance genes may get acquired by difficult-to-control weeds

"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 true of DDT?"

DDT accumulates in birds which produced soft-shelled eggs that easily gets crushed

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 amount of pesticide allowed to remain in food

"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 may be acquired by pathogenic gut microbes

____________________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 New Animal Drug Application (NADA) for AquAdvantage was finally approved by the FDA in 2016 with genetic use restriction technologies (GURT) implemented. What does not apply to GURT in relation to AquAdvantage?

GURT can be accomplished by selling Aquadvantage in Canada and Mexico only

"In section 402 of FFDCA, foods that bear poisonous substances are referred to as __________, while section 409 covers regulations on __________, which are substances that are not a normal constituent of foods."

adulterated:additives

What product is not under the regulatory jurisdiction of FDA's Center for Veterinary Medicine?

Vaccines to protect cows from anthrax

"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

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

Substantial equivalence

"The GE microbe homework deals with EPA notification requirements for genetically modified microbial pesticides. From section 172.43, ____________________ microbial pesticides are microbial pesticides brought into the United States and other US territories that came from outside those areas"

non-indigenous

After FDA's assessment of bioengineered foods what is the regulatory endpoint when the GMO is approved for marketing because it is not substantially different in composition from the non-engineered counterpart?

No concerns

What is not true about the first product from a genetically engineered (pharmed) animal to be approved by the FDA?

A functional human gene was knocked into a horse's genome

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

Ephedrine added to dietary supplements for weight loss is classified as GRAS

"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 itself might be directly toxic or allergenic

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

Non-genetically modified food crops do not contain toxins

The Safe and Accurate Food Labeling Act of 2015:

Is a federal law that requires a quick response code in GMO produce

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?

Labels should clearly state that adult supervision is required

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

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

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

Manufacture of generic drugs that are much less expensive than branded pharmaceuticals

What is not true of the Pure Food and Drug Act of 1906?

Prohibited false therapeutic claims on labels .

"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."

Phenobarbital

What widely used drug for arthritis was withdrawn from the market after it was linked to heart problems and strokes?

Vioxx

FDA's primary response to the urgent need of patients for another effective drug against AIDS was to allow the marketing of less expensive generic copies of branded AIDS drugs

FALSE

"Harvey Wiley's "clinical trials" with the poison squad tested the toxic effects of food preservatives. Which of these still widely used preservative 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."

Potassium nitrate

***The ones that are still in use are...

Potassium Nitrate - (saltpeter) used in preserved meats

Sulphur Dioxide and Sulphites - common preservative in wine

Benzoic Acids and Benzoates - a broad spectrum microbiocide in agriculture

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

Bureau of Custom's emergency hotline

What safety crisis led to the Federal Anti-tampering Act of 1982 which required the use of tamper-evident devices in over-the-counter drugs?

Death from Children's Tylenol that was laced with cyanide

"Prior to the establishment of the FDA, control over drug quallity and trade was inconsistent because ____________________ exercised principal control over domestically produced and distributed foods and drugs."

States

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

What is the major health crisis that led to enactment of the Drug Quality and Security Act of 2013?

Fungal meningitis due to a contaminated compounded steroid

What is not true of the Prescription Drug Marketing Act of 1987?

Passed to help accelerate the approval process for new drug applications

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?

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?