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In section ____________ of FFDCA covers regulations on additives, which are substances that are not a normal constituent of foods, while in section ________, foods that bear poisonous substances are referred to as adulterated.
402: 403
402:409
409:402
403:402
409:402
3 multiple choice options
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
the levels of pesticide that would not kill animals
the level of a pesticide that insect pests can tolerate
the level of pesticide that won't be toxic to farmers spraying them
the amount of pesticide allowed to remain in food
3 multiple choice options
What is not true about foods that are classified as GRAS?
Dietary supplements are regulated as food products and classified as GRAS
GRAS stands for Generally Recognized as Safe
Food that is GRAS requires FDA review and approval before marketing
Monosodium glutamate, or MSG, is a common food flavoring classified by the FDA as GRAS
Food that is GRAS requires FDA review and approval before marketing
3 multiple choice options
What does not apply to GMO or non-GMO plants?
recombinant DNA technology introduces well-defined traits to engineered plants
FDA regulates GMO foods produced by rDNA techniques similar to foods produced by traditional breeding techniques
Many of today's food crops generated by mutagenic chemicals or radiation contain one to a few well-characterized mutations
Traditional selective breeding of plants for increased productivity is a form of genetic manipulation.
Many of today's food crops generated by mutagenic chemicals or radiation contain one to a few well-characterized mutations
3 multiple choice options
Choose the best answer. What is true of a food additive?
Additives include substances whose normal levels in food may have been increased by human intervention
The artificial sweeteners and flavors used in ice creams are not considered additives
Unlike chemical additives, additives that are introduced to food by genetic engineering are exempt from the requirement for FDA approval prior to marketing
Genetic engineering does not lead to presence of additives in food products
Additives include substances whose normal levels in food may have been increased by human intervention
3 multiple choice options
What is not true regarding FDA's 1992 policy the regulation of genetically engineered food crops?
Genetically engineered foods are to be regulated differently from crops which are products of traditional breeding techniques
The FDA recommends that new plant variety developers consult with them starting from the development stage
The effect of genetic modification on levels of toxic substances should be assessed as they could have altered the composition of food
The regulatory status of a new food crop depends on characteristics and use of the food product, regardless of process used to develop the new crop
Genetically engineered foods are to be regulated differently from crops which are products of traditional breeding techniques
3 multiple choice options
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 get integrated in the human genome
The resistance genes may be acquired by pathogenic gut microbes
Antibiotic resistance protein can remain active in the gut and break down ingested antibiotic
The resistance genes may be acquired by pathogenic gut microbes
3 multiple choice options
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 month
4 months
2 months
6 months
4 months
3 multiple choice options
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 but can be found in nature
Food that has been modified through rDNA techniques in a way that could be obtained through conventional breeding but not found in nature
Food that has been modified through rDNA techniques in a way that could not be obtained through conventional breeding or found in nature
Food that has been modified through rDNA techniques in a way that could be obtained through conventional breeding or found in nature
Food that has been modified through rDNA techniques in a way that could not be obtained through conventional breeding or found in nature
3 multiple choice options
It is possible that a plant produced by genetic engineering using recombinant DNA technology will not contain foreign genetic material.
TRUE or FALSE
TRUE
1 multiple choice option
Which of these genetically-engineered food products might be required to be labelled as bioengineered?
Table sugar is made from GE insect resistant sugarcane
Oil prepared from canola engineered with a RoundUp resistance gene
Papaya engineered to be resistant to papaya ringspot virus
Wine produced from grapes engineered to be resistant to grape fan leaf virus
Papaya engineered to be resistant to papaya ringspot virus
3 multiple choice options
What product is not under the regulatory jurisdiction of FDA's Center for Veterinary Medicine?
Flea medication for dogs
Antibody drug for cancers in dogs
Chicken feed
Veterinary devices
Antibody drug for cancers in dogs
3 multiple choice options
What is not true about the first product from a genetically engineered (pharmed) animal to be approved by the FDA?
The recombinant human protein is mainly expressed and produced in the mammary glands of the genetically-engineered animal
A functional human gene was knocked into a pig's genome
The recombinant product is human antithrombin
The rDNA introduced is regulated as a drug because it affects the biological functions of the engineered animal
A functional human gene was knocked into a pig's genome
3 multiple choice options
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?
Genetic use restriction technologies (GURT) by releasing only female transgenic fish
Geographical containment by selling Aquadvantage outside of the US only
Physical containment by growing Aquadvantage only in land-based facilities that are far from the ocean
Physical containment by placing nettings over the Aquadvantage tanks to minimize chance of their escape
Geographical containment by selling Aquadvantage outside of the US only
3 multiple choice options
A New Animal Drug Application approval for transgenic animals, which are to be used for food or to produce drugs, requires that the gene introduced to the animal:
should code for a therapeutic protein
is safe to consumers if bioengineered animal is to be used as food
should have a novel function
should not be passed on to the transgenic animal's offsprings
is safe to consumers if bioengineered animal is to be used as food
3 multiple choice options