BTEC 3317 EXAM 1 UH

Using a gene in bacteria, many U.S. crops have been genetically modified to be resistant to the herbicide, Roundup.

What is a major concern with plants genetically engineered to be Roundup resistant?

RoundUp resistance gene can be passed on to and acquired by weeds.

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

Possible carry over of excess erythropoietin from the animal to human

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

Facilitate the degradation of crude oil components

What does not apply to endotoxins?

A drug contaminant that causes an out of control immune response in drugs that are formulated as syrups

Plants that produce insecticidal Bt or Cry toxin had 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 may kill Bees that are required for pollination of certain flowers.

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

Hyperimmune response by the fetus

In the First generation of plants that were engineered to be resistant to viruses. One major concern is that...

More pathogenic virus strains could arise

What is not a major reason for the need to regulate biotechnology products and their development and manufacturing?

Assure job security for FDA employees

Human glucocebrosidase, for treatment for Gaucher's disease, has been successfully produced using carrot cells.

What is a major advantage of producing biotherapeutics in plants vs. in animals?

Less likelihood of contamination by animal viruses

What is the best definition of Biotechnology?

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

Vaccines against many disease have been successfully produced in plants. Vaccine against rotavirus (causes diarrhea, vomit, dehydration, and death) was produced with what plant?

Alfalfa

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

A clinical trial participant died from an intense immune response to the viral vector

AquaAdvantage salmon was genetically engineered to grow faster than native salmon.

What is the main concern why FDA took 19 years to approve its commercialization?

It might outgrow and displace native salmon.

What was a regulatory concern with FlavRSavR tomato?

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

Genzyme plant in Massachusetts produces biotehrapeutic enzyme replacement for people with Gaucher's disease. the plant was shut down by the FDA causing a drug shortage for many patients.

Why did they shut it down?

A virus contaminant was found in their cell cultures.

The USDA requires a permit for the introduction of regulated organisms.

From the USDA regulations, which is not included as a type of introduction?

Introduction of a transgene into a plant in one of the NSM laboratory

From the USDA regulations, these are labeled types of introductions.

1) Interstate transport of the regulated article from Texas to California

2) Importation of a regulated organism from Japan to U.S.

3) Transport of regulated organism from Florida to Georgia

4) Release of regulated organism from lab into the environment for field testing

What is not a 2013 goal of the Advisory Committee on Biotechnology & Century Agriculture?

Evaluate the economic advantage of using organic vs. inorganic fertilizers

The 2013 goals of the Advisory Committee on Biotechnology & 21st Century Agriculture (AC21).

1) Gather data on unintended GE presence in commercial non-GE seed supplies for identity preserved production of non-GE plants

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

Development of a GM plant takes 9 years. Part of the Requirements for new plant varieties.

What process is done to get rid of possible unwanted sequences from a vector (agrobacterium tumefaciens) used in introducing the gene into the GE plant.

Backcrossing with the parental line.

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

CFR ___ 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.

CFR 7, Part 340

1971, Paul Berg combined E. coli DNA, SV40 that causes cancer in apes.

To address Human health & environmental concerns with similar experiments in the future NIH (National Institute of Health) formed _____ in 1974.

Recombinant DNA Advisory Committee (RAC)

(TRUE or FALSE) Transfer of genetic material from microbes to taxonomically unrelated organisms occur in the laboratory under artificial conditions.

Transfer does not take place naturally outside of the controlled conditions in a laboratory.

False

What is not true about the Animal and Plant Health Inspection Services' (APHIS) permit system for GMO testing?

Permit must be submitted 30 days before the planned field testing of the genetically engineered plant

What does not apply to CFRB and its policies ?

CFRB stands for Centralized Framework for the Regulation of Biotechnology

What applies to the CFRB and its policies ?

1) assign jurisdiction on regulation of biotech products to the FDA, EPA, and or USDA based largely on the intended use

2) Pseudomonas strain engineered with Agrobacterium is considered to be a new organism

3) intended to ensure thesafety of biotech research and products

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

What is not true of Laws?

successful passage of laws is not influenced by industries nor by public opinion

What is true of Laws?

1) Laws are alternatively referred to as statutes, Acts, or codes

2) Federal laws have power over contradictory state laws

3) Courts can block implementation of laws

4) Proposed state laws don't need the approval and signature of the President of the United Sates before they can be implemented

Developer has collected enough evidence that a GE organism poses no more of a plant pest risk than an equivalent non-GE organism.

Developer may _____APHIS to determine ______ status for the GE organism.

Petition, non-regulated

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

What is not true of laws or regulations?

Laws and regulations are both found in the US Code

What is true of laws or regulations?

1) Laws and regulations are both enforceable

2) Failure to follow laws or regulations have legal consequences

3) Laws are written or proposed by legislative bodies

4) Regulations are written by federal agencies to provide

What act requires for pesticide registration and for Experimental Use Permits?

Federal Insecticide Fungicide and Rodenticide Act

Patents protect inventions for up to 20 years.

Papaya genetically engineered to be resistant to the papaya ring-spot virus, when does intellectual property protection activity starts?

Starting from design of the gene construct for virus resistance

EPA responsible for "regulating pesticides, novel microorganisms, and herbicide resistant plants

CFR 40

(True or False) EPA is lead federal agency in regulating pain medications, anti-depressants, and sleep aid?

FASLE

Creation of the 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 2018, DDT was the most widely used agricultural pesticide in the US"

What is true of DDT?

1) It lead to bird eggs with thin shells get crushed when tried to be incubated.

2) effective in controlling the incidence of mosquito-vectored diseases like the Zika virus

3) contributed to the near extinction of many bird species

4) very effective insecticide against important crop pests

What product is the EPA not involved in regulating?

Chicken vaccines against Salmonella

What is the EPA involved in Regulating?

1) Rat Poison

2) Novel microorganisms

3) Herbicide-resistant plants

4) Biopesticides

First EUP (experimental Use Permit) 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 was not a precaution that was implemented during the field testing?

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

What were the precautions that was implemented during field testing the first EUP strawberry?

1) EPA observer was present during the experimental application

2) applicators wore protective clothing

3) GE microbe was applied to plants within a 0.2 acre land area

4) Test plot was surrounded by a 15 meter wide bare soil buffer zone

Registration refers to federal pre-marketing approval of biopesticides.

What would not be regulated by U.S. EPA as a biopesticide?

synthetic mosquito repellent, DEET

What would be regulated by the EPA as a biopesticide?

1) Gram negative bacterium, Pseudomonas fluorescens, for controlling fungal pathogens of plants

2) cry toxin genes that are engineered in agronomically important crops to protect against insects

3) mutant strain that protects crops from frost damage by a pathogenic bacterial strain

4) pesticide, Rotenone, which is extracted from the roots of some legumes

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

Field testing of watermelon engineered with Bt is not required since Bt had been approved previously for use in corn

What is true of EPA's EUP (Experimental Use Permit)?

1) field test is less than 10 acres of land

2) EUP will not be issued for testing in waters that affect fish, shellfish, or plants that are to be taken as food

3) Public comments are solicited before approval

4) EUP is not required for laboratory or greenhouse tests

Which federal agency bans monopolies by drug companies?

Federal Trade Commission

What is not a concern that EPA focuses on?

increased sugar content of the transgenic fruit

Toxic Substances Control Act

a manufacturer must submit a ____ 90 days before the manufacture or import of intergeneric microorganisms for commercial purposes

Microbial Commercial Activity Notice

Resource Conservation and Recovery Act

banned the disposal of hazardous waste in landfills

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...

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

under FIFRA, what is regulated by the EPA in a transgenic plant expressing a plant-incorporated protectant?

The transgene and the protective protein product of the transgene

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

Banana engineered to produce a hepatitis B vaccine

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

Antibody drug for cancer in dogs

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, Misbranded

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 taken up by gut microbes that cause disease

FDA’s assessment of bioengineered foods, a regulatory endpoint of ""No concerns"" would mean that..

GMO is approved for marketing because it is not much different in composition from the non-engineered counterpart

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

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

Substantial equivalence

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

rDNA introduced is not regulated as a drug because it does not affect the biological functions of the engineered animal

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?

Physical containment by growing Aquadvantage in net pens in open water.

What are the containment safeguards in NADA for AquAdvantage?

1) Genetic use restriction technologies (GURT) by raising only female transgenic fish in the US

2) Physical containment by placing nettings over the Aquadvantage tanks

3) Geographical containment by breeding Aquadvantage outside of the US

4) Genetic use restriction technologies (GURT) by raising only sterile, triploid fish

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

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

GRAS products are marketed after a thorough and formal review of its safe use by the FDA

What is true about classification of GRAS?

1) GRAS includes pepper, salt, vinegar, oil, spices and natural flavors

2) GRAS stands for Generally Recognized as Safe

3) FDA can stop the distribution of a product classified as GRAS

4) GRAS had been known based on long history of use in food

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

Non-genetically modified food crops do not contain toxins

National Bionegineered Food Disclosure Law:

Is a federal law that allows the use of quick response codes to disclose the presence of GE material in food products

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

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

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

Quinine that did not work in protecting against yellow fever

What anti-diabetic and anti-inflammatory drug was withdrawn from the global drug market because it causes liver dysfunction and failure?

Rezulin

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?

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

Federal Anti-Tampering Act of 1982 enforced the following packaging requirements...

1) Tamper-evident device should be prominently displayed

2) Device should provide clear and visible evidence if tampering has occurred

3) Tamper-evident device should be identified on label

4) Tamper-evident package should be distinctive by design

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

The Act prohibited false therapeutic claims on labels

Pure Food and Drug Act of 1906:

1) Act prohibited interstate commerce in adulterated drugs

2) Act required labeling that is not false or misleading

3) Act did not require drugs to be both safe and efficacious

4) Act required listing of certain substances including cocaine, heroin, alcohol and morphine

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?

Food, Drug and Cosmetic Act of 1938

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

Studies that show comparable bioavailability of the active ingredient in human subjects are waived

Hatch-Waxman Act of 1984?

1) Provided patent holders an extended term of protection from competition in the market place if there is delay in obtaining marketing approval

2) Large and expensive clinical trials are not required for marketing approval of the copycat drugs

3) Generic drugs can be marketed only if the patent of the pioneer drug had expired

4) Encouraged the manufacture and marketing of less expensive copies of branded drugs

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

Illegal sale of drug samples given to physicians

Drug Quality and Security Act of 2013?

1) Implementation of electronic and interoperable system to track certain prescription drugs in the U.S

2) Required registration of companies that mix custom medications from bulk drug suppliers

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?

Informed consent forms describing possible bad effects on participants health were signed prior to trial commencement

What was true of the clinical trial of Dr. Harvey Wiley's "clinical trials".

1) No carcinogenic, mutagenic, or teratogenic studies were done prior to testing in humans

2) No animal safety studies of the preservatives were done prior to the testing in humans

3) There was no untreated control group for comparison with the group that was given the preservatives

What does not apply to patent medicines?

Patent medicines do not work for any type of ailment

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?

1) Benzoate

2) Sulphite (Sulphur Dioxide)

3) Potassium Nitrate

Prescription Drug Users Fee Act of 1992 was passed mainly to:

Shorten the time for new drug review and marketing approval

Encourage the development of safer and more effective drugs

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

Legislated due to lack of enough effective drugs for AIDS

Prescription Drug Marketing Act of 1987?

1) Arose from concerns about illegal sale of excess pharmacy inventories

2) Samples of prescription drug products may be distributed only if a licensed prescriber requests them

3) required that prescription drugs manufactured in the US and exported, can no longer be reimported into the US

4) Intended to reduce risks from misbranded or counterfeit drugs

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 tetanus toxin

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

Bureau of Custom's emergency hotline

Fair Packaging and Labeling Act of 1966?

1) quantity of the product

2) identity of the product

3) address of manufacturer

4) information on benefits and risks of the product