FDA - Biotech Food Regulations Flashcards
Foods that bear poisonous substances are referred to as adulterated. In section __________ of the Federal Food, Drug, and Cosmetic Act (FFDCA), products where material information were omitted or inaccurate claims included are referred to as misbranded, while section __________ covers regulations on additives, which are substances that are not a normal constituent of foods.
A) 401:402
B) 403:402
C) 402: 403
D) 402:409
E) 403:409
E) 403:409
What is FDA’s standard definition of bioengineered food?
A) 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
B) Food that has been modified through conventional breeding and not found in nature
C) Food that has been modified through rDNA techniques in a way that could not be obtained through conventional breeding or found in nature
D) Food that has been modified through rDNA techniques in a way that could be obtained through conventional breeding or found in nature
E) Food that has been modified through rDNA techniques in a way that could be obtained through conventional breeding but not found in nature
C) Food that has been modified through rDNA techniques in a way that could not be obtained through conventional breeding or found in nature
It is possible that a plant produced by genetic engineering using recombinant DNA technology may not contain foreign genetic material.
TRUE
Which of these genetically-engineered food products might be required to be labelled as bioengineered?
A) Oil prepared from canola engineered with a RoundUp resistance gene
B) Vinegar produced from sugarcane engineered to be resistant to a virus
C) Sugar from a sugar beets engineered with a virus resistant gene
D) Papaya engineered to be resistant to papaya ringspot virus
E) Wine produced from grapes engineered to be resistant to grape fan leaf virus
D) Papaya engineered to be resistant to papaya ringspot virus –> actual plant engineered
What product is not under the regulatory jurisdiction of FDAs Center for Veterinary Medicine?
A) Flea medication for dogs
B) Dog and cat food
C) Antibody drug for cancers in dogs
D) Chicken feed
E) Veterinary devices
C) Antibody drug for cancers in dogs
What is not true about the first product from a genetically engineered (pharmed) animal to be approved by the FDA?
A) The recombinant product is human antithrombin
B) A functional human gene was knocked into a pig’s genome
C) The rDNA introduced is regulated as a drug because it affects the biological functions of the engineered animal
D) The product is designed to inhibit blood clotting in patients deficient in the protein
E) The recombinant human protein is mainly expressed and produced in the mammary glands of the genetically-engineered animal
B) A functional human gene was knocked into a pig’s genome
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?
A) Physical containment by growing Aquadvantage only in land-based facilities that are far from the ocean
B) Genetic use restriction technologies (GURT) by releasing only sterile, triploid fish
C) Physical containment by placing nettings over the Aquadvantage tanks to minimize chance of their escape
D) Geographical containment by selling Aquadvantage outside of the US only
E) Genetic use restriction technologies (GURT) by releasing only female transgenic fish
D) Geographical containment by selling Aquadvantage outside of the US only
What is true about foods that are classified as GRAS?
A) GRAS stands for Generally Regulated as Safe
B) Monosodium glutamate, or MSG, is a common food additive that the FDA does not require inclusion in labels because it is classified as GRAS
C) Products classified as GRAS require FDA review and approval before marketing
D) Pepper, salt, vinegar, oil, spices and natural flavors are not classified as GRAS
E) The FDA can stop the distribution of a product classified as GRAS
E) The FDA can stop the distribution of a product classified as GRAS
What does not apply to GMO or non-GMO plants?
A) Non-genetically modified food crops do not contain toxins
B) recombinant DNA technology introduces well-defined traits to engineered plants
C) recombinant DNA technology introduces 1 to a few known genes and gene products to engineered plants
D) Many of today’s food crops generated by mutagenic chemicals or radiation contain many uncharacterized mutations.
E) Traditional selective breeding of plants for increased productivity is a form of genetic manipulation.
A) Non-genetically modified food crops do not contain toxins
Choose the best answer. What is not true of a food additive?
A) An additive is substance whose normal levels in food may have been increased by human intervention
B) A substance found at normal levels in food is not considered an additive
C) Additives can be introduced into a plant by genetic engineering
D) Food additives, including those introduced by genetic engineering, do not require FDA approval prior to marketing
E) Emulsifiers and artificial sweeteners used in ice cream are considered additives
D) Food additives, including those introduced by genetic engineering, do not require FDA approval prior to marketing
What is not true regarding FDA’s 1992 policy the regulation of genetically engineered food crops?
A) 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
B) The effect of genetic modification on levels of toxic substances should be assessed as they could have altered the composition of food
C) The FDA recommends that new plant variety developers consult with them starting from the development stage
D) The FDA requires biotech food developers to identify safety and nutritional issues with their new plant varieties.
E) Genetically engineered foods are to be regulated differently from crops which are products of traditional breeding techniques
E) Genetically engineered foods are to be regulated differently from crops which are products of traditional breeding techniques
FDA’s health safety assessments of GE foods are based in part on the concept of ______________ to non-GE crops.
A) Horizontal gene transfer
B) Nutritional superiority
C) Substantial equivalence
D) Adventitious presence
E) Nutritional equivalence
C) Substantial equivalence
From FDA’s 1992 policy on new plant varieties, after FDA’s assessment of bioengineered foods, a regulatory endpoint of “consult FDA” would mean that:
A) the GMO is approved for marketing because it is not much different in composition from the non-engineered counterpart
B) the GMO is not approvable for marketing, because the bioengineered plant has increased levels of a natural plant toxin
C) the GMO is not approvable for marketing, because the bioengineered plant produces a new toxin
D) FDA wants more tests to show that no unwanted DNA sequences were inadvertently introduced in the bioengineered plant
E) the GMO is not acceptable, perhaps due to safety concern with the bioengineered plant
D) FDA wants more tests to show that no unwanted DNA sequences were inadvertently introduced in the bioengineered plant
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:
A) The resistance genes may get integrated in the human genome
B) The resistance genes can be transferred to weedy plant varieties
C) The ingested antibiotic resistance protein may be toxic or allergenic
D) The resistance genes may be acquired by pathogenic gut microbes
E) Antibiotic resistance protein can remain active in the gut and break down ingested antibiotic
D) The resistance genes may be acquired by pathogenic gut microbes
In 2001, FDA required developers to submit a scientific and regulatory assessment of their new GE crop about ___________ before the bioengineered food is marketed.
A) 30 days
B) 120 days
C) 60 days
D) 6 months
E) 1 yr
B) 120 days
