Genetically Engineered (GE) Crops and Animals

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Questions and Answers

What is a primary factor contributing to the limited commercialization of genetically engineered (GE) livestock, despite initial optimism?

  • Predominantly public research funding initiatives.
  • Simple regulatory pathways for GE livestock approval.
  • Regulatory obstacles and public opinion concerns. (correct)
  • High rates of transgene integration in livestock.

What aspect did early reviews of GE livestock production often emphasize, despite acknowledging technical challenges?

  • Optimistic projections for future developments and applications. (correct)
  • Pessimistic conclusions regarding future viability.
  • Comprehensive analysis of regulatory obstacles.
  • Detailed risk assessments for environmental impacts.

What did Simons & Land foresee regarding the application of genetic engineering technology in livestock as early as 1987?

  • Classification of the technology as a drug or infectious agent.
  • Exclusion of the technology from existing legislation.
  • Immediate acceptance of the technology without regulatory concerns.
  • Dependence on the establishment of a suitable social framework. (correct)

What key advancement in the field of animal genetics significantly contributed to the implementation of genomic selection in livestock?

<p>Sequencing of genomes of various food animal species. (B)</p> Signup and view all the answers

How has the sequencing of the cattle genome impacted genetic improvement in the dairy industry?

<p>It has doubled the rate of genetic improvement. (B)</p> Signup and view all the answers

What is a limitation of using somatic cell nuclear transfer (SCNT) for producing GE livestock?

<p>Low efficiency of producing live and healthy cloned offspring. (A)</p> Signup and view all the answers

What factor significantly contributes to the high cost of producing transgenic livestock?

<p>Paucity of public sector and private funding. (D)</p> Signup and view all the answers

What is the primary method used to produce livestock carrying nuclease-mediated genetic changes in their genomes?

<p>Somatic cell nuclear transfer of edited somatic cells. (C)</p> Signup and view all the answers

What traits are commonly targeted with gene editing in livestock, aligning with objectives of traditional selection programs?

<p>Animal health and well-being, product quality, and yield. (D)</p> Signup and view all the answers

How does the livestock breeding sector differ from the plant breeding sector regarding focus?

<p>Livestock breeders focus selection on elite animals, with genetically distinct individuals. (D)</p> Signup and view all the answers

Which factor most significantly influences the level of investment directed toward developing genetically improved founders in the breeding nucleus?

<p>High degree of vertical integration in the animal agriculture industry. (B)</p> Signup and view all the answers

What text was included in the annual USDA request for grant applications for almost a decade starting in the mid-2000s?

<p>&quot;Applications whose primary aim is to improve the efficiency in the production of clones or transgenic animals through manipulation of the nucleus will no longer be accepted by the Animal Genome program.&quot; (C)</p> Signup and view all the answers

According to the FDA's 2009 Guidance Document 187, what constitutes the "regulated" article in a GE animal?

<p>The rDNA construct in a GE animal, intended to affect the animal's structure or function. (A)</p> Signup and view all the answers

How did the FDA exercise enforcement discretion regarding GE animals of nonfood species used in research institutions?

<p>By exempting them from INAD paperwork requirements. (A)</p> Signup and view all the answers

What is a key consideration in the FDA's risk assessment for each line of GloFish® marketed in the United States?

<p>Human health risks, ecological health risks, and risks to the fish themselves. (A)</p> Signup and view all the answers

What factor influenced the FDA's decision to exercise enforcement discretion for GloFish®?

<p>Zebra danios cannot survive outside of tropical waters. (C)</p> Signup and view all the answers

According to Alan Blake, CEO of Yorktown Technologies, what drives consumer purchase of transgenic animals, at least as aquarium pets?

<p>The product's attributes and perceived value, irrespective of the breeding method. (B)</p> Signup and view all the answers

What is the significance of the 2017 FDA guidance update regarding the regulation of intentionally altered genomic DNA in animals?

<p>It proposes regulating all food animals with intentionally altered genomes as new animal drugs. (C)</p> Signup and view all the answers

What impact has the adoption of GE crops had on the livestock sector?

<p>Indirectly benefitted the sector through less expensive feedstocks. (B)</p> Signup and view all the answers

What was the estimated cost related to eyesight years lost with a one year delay in the introduction of golden rice, a crop with vitamin A?

<p>1.1-5 million eyesight years lost which translated to a dollar cost of $300 million–$1.2 billion (A)</p> Signup and view all the answers

What is the estimated global annual cost associated with Staphylococcus aureus mastitis in dairy cows?

<p>Approximately $3.9 billion. (A)</p> Signup and view all the answers

What was the estimated cost associated with delaying the FDA approval by 5 years, for S. aureus mastitis resistant cows?

<p>Approximately $990 million to $1.96 Billion (C)</p> Signup and view all the answers

Between what years is the cost framework for the 30 year net present value (NPV) evaluation of S. Aureus mastitis

<p>2015-2044 (C)</p> Signup and view all the answers

Which countries, with improved dairy genetics, were used to estimate the cost of delaying the introduction of mastitis-resistant cows?

<p>Subsets of countries of Europe and the United States (B)</p> Signup and view all the answers

The 2018, mainland China had more than 442 million pigs, what perfect of all live pigs is this in the world?

<p>45% (C)</p> Signup and view all the answers

What does PRRS stand for?

<p>Porcine Reproductive and Respiratory Syndrome (A)</p> Signup and view all the answers

Between what years is the cost framework for the 30 year NPV evaluation of PRRS virus-resistant pigs

<p>2020-2049 (B)</p> Signup and view all the answers

What were the findings around AquAdvantage salmon?

<p>The AquAdvantage salmon did grow faster than their conventional counterparts (C)</p> Signup and view all the answers

What rDNA in aqua advantage enabled a faster growth rate?

<p>Combination of growth hormone gene from Chinook salmon and and anti freeze gene from ocean pont (D)</p> Signup and view all the answers

Flashcards

Opportunity Cost

The cost of delaying or preventing the potential benefits of a technology because of regulatory delays or other obstacles.

Genetically Engineered (GE) Livestock

Livestock whose genetic material has been altered using gene editing or transgenesis techniques.

Genome Editing

A technique that introduces a double-stranded break at a targeted location in the genome to modify genes.

AquAdvantage Salmon

A GE salmon that grows faster due to a growth hormone gene, approved for sale after significant regulatory delays.

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Coordinated Framework for the Regulation of Biotechnology

A framework outlining how the US government regulates biotechnology products.

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Federal Food, Drug, and Cosmetic Act (FD&C Act)

This act defines a drug as any article intended to affect the structure or function of an animal's body.

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New Animal Drug Application (NADA)

A formal request and regulatory process required for obtaining approval to commercialize a new animal drug.

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Veterinary Medicine Advisory Committee (VMAC)

A committee convened to review and offer recommendations to the FDA regarding new veterinary drugs.

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Mastitis

A disease of the mammary gland in dairy animals, costing the global industry billions annually.

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PRRS Virus-Resistant CD163 Knockout Pigs

Knockout pigs resistant to PRRS virus, developed using genome editing to remove the CD163 gene.

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Atlantic Salmon

A major farmed cold-water fish with a high level of world production.

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Herd books

The ability to trace the pedigree or ancestry of selected animals

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rDNA construct

Animals carrying new Deoxyribonucleic acid

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opportunity cost

The loss of potential gains or benefits from missed chances of production and investment

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Study Notes

Introduction

  • GE crops have been commercialized for >22 years.
  • In 2018 alone, GE crops were grown on 191.7 million hectares by 17 million farmers in 26 countries
  • Only one GE food animal has ever been commercialized.
  • Some authors foresaw potential regulatory and social license issues as far back as 1987
  • Simons & Land predicted that application of the technology is dependent on establishing a suitable social framework.
  • Transgenic practices could enhance the advantages of genetic improvement increasing the rate at which characteristics of stock could meet community requirements.
  • A 1990 review lamented the lack of mapped genomes in domestic animals but suggested livestock breeding would drastically change before the turn of the century if this hurdle were surmounted.
  • Dr. Jim Womack forecast that mapping over 200 polymorphic loci in any livestock species in the near future was a formidable task
  • Sequencing the entire bovine genome was reported 22 years after that paper was published.
  • The number of sequenced bovine genomes grew to more than 2,700 animals.
  • These developments were enabled by massive investments in sequencing technologies and large consortiums.
  • Genomic sequence data has been used to implement genomic selection on a very large scale in pigs, sheep, and cattle, with millions of animals having been genotyped.
  • Enabling genomic-based selection of young elite bulls following the sequencing of the cattle genome doubled the rate of genetic improvement in the dairy industry.
  • Georges & Andersson predicted transgenic tools would become a key component for testing hypotheses with regard to function and regulation of underlying genes uncovered by genomic approaches.
  • Dolly, the first cloned mammal, was reported in 1996, which opened the way to cloning livestock from GE somatic cells, coinciding with the promulgation of the US Coordinated Framework for the Regulation of Biotechnology.
  • Wall reported that 24% of published papers in PubMed were review articles when searching the term “transgenic livestock"
  • Today, about 30% of the same search results are review articles

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