Biosafety, Risk Assessment & Risk Management, Regulations Flashcards

1
Q

What is modern biotechnology?

A

Modern biotechnology refers to the use of techniques such as in vitro nucleic acid techniques, including recombinant DNA (rDNA), and direct injection of nucleic acid into cells or organelles, or fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and are not techniques used in traditional breeding and selection.

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2
Q

What is a GMO or LMO?

A

GMO or LMO stands for genetically modified organism or living modified organism, respectively. It refers to any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology.

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3
Q

What is the global area of biotech crops in 2020?

A

In 2020, the 25th year of commercialization of biotech crops, there was a 113-fold increase in the global area of biotech crops.

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4
Q

What are some mega countries in biotechnology?

A

Some mega countries in biotechnology include the USA, Brazil, Argentina, Canada, and India.

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5
Q

What are the most planted biotech crops in 2018?

A

The most planted biotech crops in 2018 were corn, soybeans, cotton, alfalfa, sugar beets, canola, squash/zucchini, papaya, potato, and apple.

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6
Q

What are some traits found in GMO crops?

A

Traits found in GMO crops include herbicide tolerance (soybean, maize, canola, cotton, sugar beet, and alfalfa), as well as stacked trait products such as herbicide tolerance and insect resistance.

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7
Q

What are some concerns about the use of GMOs?

A

Concerns about the use of GMOs include their potential impact on human health, the environment, and biodiversity.

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8
Q

What is the FDA’s current policy on GMO foods?

A
  1. The FDA’s current policy on GMO food is that it has no basis for concluding that bioengineered foods differ from other foods in any meaningful way or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding.
  2. GMO foods must show equivalence.
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9
Q

What are GM foods?

A

GM foods are genetically modified foods, which have been altered using biotechnology techniques to introduce specific genetic traits.

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10
Q

What is the World Health Organization’s take on GM foods being safe for human consumption?

A

GM foods currently available on the international market have passed safety assessments and are not likely to present risks to human health. No effects on human health have been shown as a result of the consumption of such foods by the general population in the countries where they have been approved,

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11
Q

What is the importance of documentation of handling practices for GM foods?

A

Documentation of handling practices for GM foods is important to ensure proper segregation procedures and to rely on certifications or affidavits from farmers, processors, and others in the food production and distribution chain, to track and verify the use of bioengineering in food production.

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12
Q

What is biosafety assessment in the context of GMOs?

A

Biosafety assessment involves the evaluation of hazards and risks associated with GMOs (genetically modified organisms). Hazards are potentially adverse outcomes of an event or activity, while risks refer to the probability and severity of an adverse event. Biosafety assessment is important in ensuring the safe use of GMOs.

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13
Q

What is risk assessment in the context of GMOs?

A

Risk assessment is the process of characterizing and quantifying risk associated with GMOs. It involves identifying and evaluating potential risks and uncertainties associated with the release and environmental effects of GMOs, and predicting and managing potential adverse impacts on the environment, human health, and biodiversity.

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14
Q

What are some factors considered in assessing ecological risk prior to GMO release?

A

Factors considered in assessing ecological risk prior to GMO release include the potential for transgene escape into the wild, the likelihood of the transgenes conferring advantageous traits or leading to the spread of weedy forms of a plant, and the potential environmental impacts of GMOs on local ecosystems.

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15
Q

What is risk management in the context of GMOs?

A

Risk management involves the implementation of strategies and measures to mitigate or minimize the risks associated with GMOs. It is important in the context of new or emerging technologies or programs that have associated risks, to ensure the safe and responsible use of GMOs.

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16
Q

What are some examples of risk management strategies?

A

Some examples of risk management strategies include anticipating detrimental effects, designing monitoring systems for early detection of adverse outcomes, and planning intervention strategies to prevent or remediate adverse effects on the environment or human health.

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17
Q

What is the purpose of a field trial in the context of genetically modified organisms (GMOs)?

A

The purpose of a field trial is to evaluate the characteristics and effects of genetically modified organisms (GMOs) in a real-world environment, such as assessing the performance, safety, and potential risks associated with GM crops or animals.

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18
Q

What are some potential risks of GM papaya?

A

Some potential risks of GM papaya include toxicity or allergenicity to humans and other organisms, weediness, and the transfer of introduced genes to other organisms.

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19
Q

What information should be provided in a risk assessment and management plan for GM papaya?

A

The risk assessment and management plan for GM papaya should include information about the parent organism, genetic modification process, introduced genes, new proteins expressed, altered phenotype of GM papaya, and risks the GMOs may pose to the health and safety of people and the environment, as well as strategies to mitigate those risks.

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20
Q

What is the parent organism of GM papaya?

A

Carica papaya L. (papaya or paw paw).

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21
Q

Where was the papaya plant domesticated?

A

Papaya was domesticated in Central America.

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22
Q

True or False: Carica papaya is not a pathogenic organism

A

True

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23
Q

What is the closest relative of Carica papaya?

A

Vasconcellea

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24
Q

In which regions is Carica papaya grown commercially and in domestic gardens?

A

Carica papaya is grown both commercially and in domestic gardens in tropical and sub-tropical countries.

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25
Q

What is the modification in GM papaya related to delayed ripening?

A

GM papaya contains additional copies of genes encoding the enzyme 1-amino-cyclopropane-1-carboxylic acid (ACC) synthase (both sense and antisense versions of the capacs 1 or capacs 2 genes from Carica papaya), which down-regulate naturally occurring ACC synthase gene activity through ‘gene silencing’

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26
Q

Which gene is active at the initial stages of fruit ripening in papaya?

A

The capacs 1 gene is active at the initial stages of fruit ripening in papaya, expressed at high levels in mature green papaya fruit, and decreases steadily during ripening.

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27
Q

What is the effect of down-regulating ethylene biosynthesis in papaya?

A

It is possible that ethylene production may also be down-regulated in plant tissues other than fruit, such as leaves or seed.

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28
Q

What is the gene encoding a modified ethylene receptor protein from Arabidopsis thaliana used in GM papaya?

A

The etr1-1 gene, encoding a modified ethylene receptor protein from Arabidopsis thaliana, is used in GM papaya.

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29
Q

What is the effect of the etr1-1 gene in GM papaya?

A

The non-functional etr1-1 gene confers ethylene insensitivity, and GM papaya plants exhibit delayed floral senescence and delayed fruit ripening. They do not show major differences in overall growth and development prior to flowering.

30
Q

How does ethylene affect plant disease resistance?

A

Ethylene is involved in plant responses to stresses such as wounding, disease resistance, or pathogen attack. Ethylene-insensitive plants have been observed to display both enhanced susceptibility and enhanced resistance to different pathogens.

31
Q

What is the function of the uidA gene from E. coli in genetic modification studies?

A

The uidA gene codes for the enzyme β-glucuronidase (GUS) which is used as a reporter or ‘marker’ to detect tissues that have been successfully genetically modified.

32
Q

What are the antibiotic resistance genes used in genetic modification studies and what do they confer resistance to?

A

The antibiotic resistance genes used are kan and neo (nptII gene) and amp (bla gene). The nptII gene confers resistance to aminoglycoside antibiotics such as kanamycin and neomycin.

33
Q

What are the sources of promoter elements used in genetic modification studies?

A

The promoter elements are from Cauliflower mosaic virus, Agrobacterium tumefaciens (a common soil bacterium), and apple (Malus domesticus).

34
Q

What methods are used for gene transfer in genetic modification studies?

A

The method of gene transfer used is microprojectile bombardment, which involves using compressed air to shoot tiny tungsten or gold particles coated with the genes.

35
Q

How can the stability of genetic modification be evaluated?

A

PCR and Southern blotting can be used to demonstrate the presence of the introduced genes, with PCR showing the presence of the genes and Southern blotting showing the number of copies of the genes. Real Time PCR is a better method for determining gene copy number.

36
Q

What are some of the pleiotropic effects that need to be evaluated in genetic modification studies?

A

Some of the pleiotropic effects that need to be evaluated include unusual responses to pathogenic or non-pathogenic microorganisms, overall agronomic performance, and compositional analysis of the fruit, to demonstrate “substantial equivalence” i.e. that the genetically modified material is “substantially equivalent” to a food not containing genetically modified material.

37
Q

What is the purpose of Northern blot analysis in the context of GM papaya plants?

A

Northern blot analysis is used to determine expression levels and functioning of the introduced genes and gene constructs in the GM papaya plants.

38
Q

What percentage of processed foods in supermarkets in the USA contain GM ingredients?

A

60% of processed foods in supermarkets in the USA contain GM ingredients, including soy, corn, canola, and some fresh vegetables.

39
Q

What are some potential risks associated with protein expression in GM foods?

A

Risks associated with protein expression in GM foods include potential toxicity and allergenicity, as well as the possibility of newly expressed proteins falling into various categories with different responses, such as being new in the food chain or being new or substantially modified proteins.

40
Q

What is the difference between toxicity and allergenicity in the context of GM foods?

A

Toxicity refers to the cascade of reactions resulting from exposure to a dose of chemical that can cause direct cellular or tissue injury, while allergenicity refers to immune system reactions resulting from stimulation of a specific group of antibodies known as IgE.

41
Q

What are some methods used for protein analysis in the context of GM foods?

A

Methods used for protein analysis in the context of GM foods include determining molecular weight, amino acid sequence, immuno-reactivity (IgE), potential glycosylation, and functional similarity.

42
Q

What are some factors considered in the assessment of toxicity and allergenicity of GM papayas?

A

Factors considered in the assessment of toxicity and allergenicity of GM papayas include the toxicity and allergenicity of non-GM papayas, the toxicity and allergenicity of the purified form of the introduced proteins, acute toxicity studies, stability of proteins in the digestive tract, and homology with known allergens.

43
Q

What is the conclusion regarding the risk of toxicity and allergenicity in GM papayas?

A

The conclusion is that the risk of toxicity and allergenicity in GM papayas is low, as the GM papayas are not likely to become more toxic or allergenic than non-GM papayas, and the introduced proteins or naturally occurring proteins with altered expression levels are not likely to be toxic or allergenic in themselves. Additionally, the exposure of humans and other organisms to GM papayas will be minimal due to the limited scale and enclosure of the trial within an insect-proof enclosure.

44
Q

What is the potential harm of GM papayas to the environment?

A

GM papayas might have the potential to be harmful to the environment due to increased potential for weediness, either as a direct result of the genetic modification or as a result of pleiotropic effects.

45
Q

How can the spread of pollen and seed from GM papayas be controlled?

A

The applicant has proposed to contain the whole release area in an insect-proof enclosure to prevent pollen flow from the release site. Additionally, the distance from other papaya fields can be considered.

46
Q

Can genes from GM papayas transfer to other papayas?

A

Gene transfer to non-GM papayas by cross-pollination is very likely, and non-GM papayas may produce seeds containing the inserted genes, resulting in papaya plants with similar traits to the GM papayas proposed for release.

47
Q

How can gene transfer to microorganisms be prevented?

A

Horizontal gene transfer (HGT) between plants and bacteria has not been demonstrated.

48
Q

What are the potential risks of gene transfer to animals from GM papayas?

A

Animals could become resistant to antibiotics due to antibiotic resistance genes in GM papayas.

49
Q

What are some risk management strategies for GM papaya release?

A

Risk management strategies may include limiting the scale of release, implementing security fencing, prohibiting use as human food, and imposing containment measures.

50
Q

What is required for a license to release genetically modified microorganisms (GEMs)?

A

The license requires the applicant to enclose the entire release site in a self-supporting insect-proof enclosure secured at ground level.

51
Q

What is the intended use of Pseudomonas syringae and Pseudomonas fluorescens GEMs?

A

The intended use of Pseudomonas syringae and Pseudomonas fluorescens GEMs is to protect crops from frost by deleting the ice nucleation membrane protein.

52
Q

What is the intended use of Pseudomonas putida GEMs?

A

The intended use of Pseudomonas putida GEMs is bioremediation and degradation of pollutants, specifically 4-ethylbenzene-degrading enzyme.

53
Q

What is the intended use of Clavibacter xyli GEMs?

A

The intended use of Clavibacter xyli GEMs is to protect plants from insects by producing BT crystal protein toxin

54
Q

What is the intended use of Baculoviruses GEMs?

A

The intended use of Baculoviruses GEMs is biological control of specific insects through the production of scorpion neurotoxin and proteases.

55
Q

What are some environmental factors that can affect the survival of GEMs in the environment?

A

Some environmental factors that can affect the survival of GEMs in the environment include soil texture, moisture, temperature, pH, plant roots, minerals, organic matter, and other organisms.

56
Q

What risks are associated with the use of GEMs?

A

All recombinant organisms, including GEMs, must be handled with caution, and experiments must follow stringent guidelines to minimize any potential risks.

57
Q

What are some characteristics of microorganisms associated with risk assessment in the context of genetic engineering of microorganisms?

A

Some characteristics of microorganisms associated with risk assessment in the context of genetic engineering of microorganisms include their growth and multiplication rates, gene exchange abilities, and stability.

58
Q

How can the ecological impact of genetically engineered microorganisms (GEMs) be measured?

A

The ecological impact of GEMs can be measured by evaluating changes in both biotic (living) and abiotic (non-living) parameters. This can include monitoring changes in CO2 evolution rates, fungal propagules, spore-forming bacteria, chitin-utilizing bacteria, biological diversity indices, and genetic interactions between introduced strains with plasmids and transposons. Gene transfer frequencies and loss of plasmid-encoded traits during storage or freeze-drying can also be measured.

59
Q

What are some biological containment systems that can minimize the potential risks of GEMs?

A

Some biological containment systems that can minimize the potential risks of GEMs include genetic systems that are designed to induce cell death in GEMs under certain conditions. These systems typically involve a killing element and a control element that regulates the expression of the killing function.

60
Q

What are some important criteria for sensitive monitoring methods used for detection and monitoring of GEMs in different environments?

A

Some important criteria for sensitive monitoring methods used for detection and monitoring of GEMs in different environments include sensitivity, specificity, reproducibility, and practicality. These methods should be able to accurately detect the presence of GEMs, differentiate them from other microorganisms, and be reproducible and practical for use in different environments.

61
Q

What are some culture techniques and immunological methods that can be used for detection and monitoring of GEMs?

A

Culture techniques can involve the use of commercial media designed for isolation of specific bacterial groups, such as enteric bacteria, faecal streptococci, pseudomonads, fluorescent pseudomonads, methanogens, and yellow-pigmented bacteria. Immunological methods can involve the use of polyclonal or monoclonal antibodies to identify specific marker genes, products, or microorganisms that express an appropriate antigen.

62
Q

What is one application of hybridization using appropriate probes?

A

One application of hybridization using appropriate probes is the detection of specific nucleic acid sequences, ranging from oligonucleotides to functional recombinant genes.

63
Q

What is colony hybridization?

A

Colony hybridization is a technique that allows for the detection of target bacteria in both environmental samples and laboratory cultures without the need for culturing the target bacteria first.

64
Q

How has PCR been used in combination with other molecular biology techniques?

A

PCR has been used in combination with other molecular biology techniques to detect low numbers of target organisms among numerous non-target microorganisms.

65
Q

What are some examples of molecular markers used for direct selection of marked strains?

A

Examples of molecular markers used for direct selection of marked strains include antibiotic resistant genes, such as amino glycoside phosphotransferase (aphII), chloramphenicol acetyltransferase (cat), puromycin acetyltransferase (pac), and tetracycline resistance (tet).

66
Q

What are some examples of luminescent markers used as reporter genes?
Answer: Examples of luminescent markers used as reporter genes include luc, lux, and gfp genes, which have been used for large-scale microbial ecological studies.

A

What are some risks unique to genetically engineered microorganisms (GEMs)?
Answer: Risks unique to GEMs include the transfer of foreign genetic material to other microorganisms, the possibility of gene transfer to deleterious organisms, and the potential for modified organisms to outcompete parent strains in certain environments, leading to unknown consequences.

67
Q

How should risk assessment be considered in connection with genetically engineered microorganisms (GEMs)?

A

Risk assessment should be considered in connection with the determination of the biological safety of released GEMs in relation to their ecological effectiveness or beneficial effects.

68
Q

What is AquaBounty Technologies’ genetically engineered salmon called and where has it been approved for human consumption?

A

AquaBounty Technologies’ genetically engineered salmon, called AquAdvantage Salmon, has been approved for human consumption in the USA and Canada by the FDA and Canadian Food Inspection Agency in November 2015.

69
Q

What are some environmental concerns associated with genetically engineered salmon?

A

Some environmental concerns associated with genetically engineered salmon include the potential for competition and interbreeding with wild fish.

70
Q

What are some risk management strategies for genetically engineered salmon production?

A

Some risk management strategies for genetically engineered salmon production include producing salmon eggs in one location, growing and processing fish in another location, limiting production to land-based facilities, isolating genetically engineered salmon from the environment, and minimizing the likelihood of harm to wild fish populations