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Animal Genomics and Biotechnology EducationAnimal Genomics and Biotechnology Education
What role will animal biotechnology
play in feeding the world?
Alison Van Eenennaam Ph.D.Alison Van Eenennaam Ph.D.
Cooperative Extension SpecialistCooperative Extension Specialist
Animal Biotechnology and GenomicsAnimal Biotechnology and Genomics
Department of Animal ScienceDepartment of Animal Science
University of California, DavisUniversity of California, Davis
alvaneenennaam@ucdavis.edualvaneenennaam@ucdavis.edu
http://animalscience.ucdavis.edu/animalbiotechhttp://animalscience.ucdavis.edu/animalbiotech
“The mission of the animal
genomics and biotechnology
extension program is to provide
broad, science-based extension
programming on the uses of animal
biotechnologies in livestock
production systems.”
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
Convention on Biological Diversity: “Convention on Biological Diversity: “BiotechnologyBiotechnology isis
any technological application that uses biologicalany technological application that uses biological
systems, living organisms or derivatives thereof tosystems, living organisms or derivatives thereof to
make or modify products or processes for specific use.”make or modify products or processes for specific use.”
Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
Genetics/breedin
g
Nutrition Health
Artificial insemination Feed additives: Amino acids,
enzymes & probiotics
Molecular diagnostics
Progesterone monitoring Prebiotics Recombinant vaccines
Estrus synchronization Silage additives (enzymes and
microbial inoculants)
Conventional vaccines
Invito fetilization and
embryo transfer
Ionophores Sterile insect technique
(SIT)
Molecular markers;
genomic selection
Single cell proteins Bioinformatics
Cryopreservation Solid state fermentation of
lignocellulosics
Semen and embryo sexing Recombinant somatotropins GREEN = Potential for
generating impact
(time frame <10 years)
Cloning Molecular gut microbiology
Transgenesis
Ortiz, Rodomiro. 2010. Agricultural Biotechnologies in Developing Countries: Options and Opportunities in Crops,
Forestry, Livestock, Fisheries and Agro-Industry to Face the Challenges of Food Insecurity and Climate Change.
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
Round Oak Rag Apple Elevation (born 1965)
>80,000 daughters, 2.3 million granddaughters,
and 6.5 million great-granddaughters
Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
VanRaden, P.M. (2007). Improving Animals Each Generation by Selecting from the Best Gene
Sources. Available: http://aipl.arsusda.gov/publish/other/2007/Duke07_pvr.pdf.
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics EducationVan Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
1944: 25.6 million animals; total annual milk production of 53.1 billion
kg. 1997: 9.2 million animals; total annual milk production of 84.2
billion kg.
About half of this 369% increase in production efficiency
is attributable to genetic improvement enabled by AI
VandeHaar, M.J. and St-Pierre, N. (2006). Major Advances in Nutrition: Relevance to the
Sustainability of the Dairy Industry. Journal of Dairy Science 89, 1280-1291.
A
I
Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
Resource use and waste outputs from modern US dairy
production systems typical of the year 2007, compared with
historical US dairying (characteristic of the year 1944).
GHG = Greenhouse
gas
Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
Average annual milk yield and carbon footprint per kg
milk - across global regions. Data adapted from FAO.,
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
Current status of animal biotechnologies
and factors influencing their applicability
in developing countries - GENETICS
Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
Extent of
use
Public and
government
acceptance
Current
technical
capability
for using
technology
Infrastructure
and materials
and tools
available for
using
technology
Relative
cost
Skills
required for
application
Potential for
generating
impact (time
frame <10
years)
ARTIFICIAL
INSEMINATION ++ +++ ++ ++ ++ ++ +++
PROGESTERONE
MONITORING + +++ + + ++ ++ ++
ESTRUS
SYNCHRONIZATION + +++ + + ++ ++ ++
IN VITRO
FERTILIZATION/
EMBRYO TRANSFER
+ +++ + + +++ +++ ++
MOLECULAR
MARKERS + +++ + + ++ +++ +
CRYOPRESERVATION
+ +++ ++ + ++ +++ ++
SEMEN AND EMBRYO
SEXING + +++ + + +++ ++ ++
CLONING
+ + + + +++ +++ +
TRANSGENESIS/GE
0 + + + +++ +++ +
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
GE Chickens That Don't Transmit
Bird Flu
Breakthrough could prevent future bird flu epidemics
www.roslin.ed.ac.uk/public-interest/gm-chickenswww.roslin.ed.ac.uk/public-interest/gm-chickens
Science 331:223-226.
2011
Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
Omega-3 PigsOmega-3 Pigs
(Pigs cloned after genetically engineering cell)(Pigs cloned after genetically engineering cell)
Nature Biotechnology 24:435-436. 2006
University of Missouri/University of Missouri/Massachusetts General Hospital and Harvard Medical
School
Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
Mastitis-resistant cowsMastitis-resistant cows
(inflammation of mammary gland)(inflammation of mammary gland)
Nature Biotechnology 23:445-451. 2005
www.ars.usda.govwww.ars.usda.gov
Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
Fast growing salmon
The founder female was generated in 1989 ~ a quarter century ago
Nature Biotechnology 10:176 – 181. 1992
University of Toronto/Memorial University of Newfoundland,University of Toronto/Memorial University of Newfoundland,
CanadaCanadaVan Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
Fish reach adult size in 16 to 18
months instead of 30 months
Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
Timeline of AquAdvantage
regulatory process
Year Event
1989 • Founder AquAdvantage fish produced in Canada
1995 • FDA review of AquAdvantage salmon begins
2001 • First regulatory study submitted by Aqua Bounty
Technologies to U.S. FDA for a New Animal Drug
Applications (NADA)
2009 • FDA guidance on how GE animals will be regulated
• FDA approval of first GE animal pharmaceutical
• Final AquAdvantage regulatory study submitted to FDA
2010 • FDA VMAC meeting on AquAdvantage salmon (9/20/10)
2011 • Political efforts to prevent FDA from regulating GE salmon
2013 • AquaBounty has expended over $60 million to bring
the AquAdvantage salmon through the regulatory
approval process thus far (D. Frank, CFO, AquaBounty, pers.
comm.)
• Still waiting for regulatory decision on AquAdvantage salmon
• Delayed approvals diminishing US investment in GE animals
24+yearsfromdiscoverytoapplication?
Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
Sites working on GE livestock for food – 1985
North America, Europe and Australasia
Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
Sites working on GE livestock for food - 2012
Asia and South America are moving forward
with this technology in their animal agriculture
Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
My basic question is thisMy basic question is this
● The first genetically engineered (GE) crops came to the market in 1986The first genetically engineered (GE) crops came to the market in 1986
● In 2012In 2012 17.3 million17.3 million farmers grew GE crop varieties on > 170 millionfarmers grew GE crop varieties on > 170 million
hectares, and of these > 90% (15 million) were small, resource-poorhectares, and of these > 90% (15 million) were small, resource-poor
farmers in developing countriesfarmers in developing countries
● Humans and livestock have consumed billions of meals without a singleHumans and livestock have consumed billions of meals without a single
case of harm attributable to the GE nature of the materials consumedcase of harm attributable to the GE nature of the materials consumed
● Currently products developed though the process of GE are singled outCurrently products developed though the process of GE are singled out
and uniquely required to go through regulatory approvaland uniquely required to go through regulatory approval
● These regulatory policies add years and millions of dollars to the cost ofThese regulatory policies add years and millions of dollars to the cost of
developing GE crops and animalsdeveloping GE crops and animals
● Is this level of scrutiny aligned to science-based risks associatedIs this level of scrutiny aligned to science-based risks associated
with this technology, or is this overabundance of precautionwith this technology, or is this overabundance of precaution
making the deployment of this valuable technology beyond themaking the deployment of this valuable technology beyond the
means of all but the largest, multinational corporations, to themeans of all but the largest, multinational corporations, to the
detriment of food security globally?detriment of food security globally?
Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
There is no scientific case for a blanketThere is no scientific case for a blanket
approval of all uses of GE. But equally there isapproval of all uses of GE. But equally there is
no scientific case for contrived safety testingno scientific case for contrived safety testing
There is always the issue of novel proteins or compoundsThere is always the issue of novel proteins or compounds
with no history of safe use. These will always have to bewith no history of safe use. These will always have to be
tested for toxicity and allergenicity– be they introduced bytested for toxicity and allergenicity– be they introduced by
GE or conventional breeding techniques.GE or conventional breeding techniques.
The bulk of safety testing and expense is to detectThe bulk of safety testing and expense is to detect
“unintended” changes specifically resulting from GE“unintended” changes specifically resulting from GE
ItIt is continued testing using ever more-expensive techniquesis continued testing using ever more-expensive techniques
including emerging “omics” for these “including emerging “omics” for these “unexpected” unintendedunexpected” unintended
effects of GEeffects of GE that is scientifically dubious as the biologicalthat is scientifically dubious as the biological
relevance of a statistically significant compositional change isrelevance of a statistically significant compositional change is
unclear – especially in the absence of data for conventional food.unclear – especially in the absence of data for conventional food.
Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
GE process-based “equivalence” studies
uniquely required for GE can no longer
justified on the basis of scientific uncertainty
Herman RA, Price WD. 2013. Unintended Compositional Changes in Genetically Modified
(GM) Crops: 20 Years of Research. J Agric Food Chem. 2013 Feb 25.
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
Unintended effects have notUnintended effects have not
materializedmaterialized
It seems more scientifically defensible to be able to stateIt seems more scientifically defensible to be able to state
that certain likely effects (e.g. novel allergens and toxins,that certain likely effects (e.g. novel allergens and toxins,
positional insertion effects) have been assessed andpositional insertion effects) have been assessed and
found absent, than to admit that one did not know quitefound absent, than to admit that one did not know quite
what to look for – but found it absent neverthelesswhat to look for – but found it absent nevertheless
“Skeptics who remain fearful sometimes respond that
“absence of evidence is not the same thing as evidence
of absence”. Yet if you look for something for 15 years
and fail to find it, that must surely be accepted as
evidence of absence. It is not proof that risks are absent,
but proving that something is absent (proving a negative)
is always logically impossible*”
* Paarlberg, R. 2010. GMO foods and crops: Africa's choice. New Biotechnology 27:609-613
Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
It is time to reconnect the GEIt is time to reconnect the GE
regulatory framework to the bestregulatory framework to the best
available scienceavailable science
“Historically, risks to the environment presented by crop plants
are low. In these projects, we think what we need to do is to
collect scientific data and understand the scientific basis for safe
use of GMO products..... We are not trying to prove how risky it
may be by strange imagination or by inventing some special
phenomena that do not occur in nature.”
Jia S, Peng Y. 2002. GMO biosafety research in China. Environ Biosafety Res. 2002 1(1):5-8.
Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
How can $60 million be warranted to bring a fast-growing
fish to market, when conventional fish (and other animal)
breeders routinely develop all manner of fast-growing
animals that are associated with the same set of risks?
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
• The trigger for regulatory review should be the novelty of the introduced
trait (regardless of how or when it was derived), and not the process
used to introduce the trait
• The severity of regulatory control should be directly related to the actual,
relative risk associated with the novel characteristic (phenotype)
• Phenotypes with a history of safe use should be exempted from
regulatory review regardless of the methods used to produce them
• Regulatory frameworks should formally evaluate the
reasonable and unique risks associated with the use of GE
animals in agricultural systems, and weigh them against
those associated with existing conventional systems, and
those of inaction (i.e. postponing a regulatory decision).
Perhaps more importantly these risks have to be weighed
against the benefits.
GE regulatory burdens are not justified by scientific evidence or
experience. While regulation to ensure the safety of new
technologies is necessary, in a world facing burgeoning
demands on agriculture from population growth, economic
growth, and climate change, overregulation is an indulgence we
can ill afford.
Giddings, V., Stepp, M. and M.E. Caine. 2013. Feeding the Planet in a Warming World
http://www.itif.org/publications/feeding-planet-warming-world
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
Some animal biotechnology applications, including GE
animals, would seem to align with many sustainability
goals including improving animal well-being – will they
be permitted to do so given current regulatory policy?
• Naturally polled cattle
• Trypanosome resistance
• Sex selection for ♀ in
dairy and egg industries
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
““the environmental movement has donethe environmental movement has done
more harm with its opposition to geneticmore harm with its opposition to genetic
engineering than with any other thingengineering than with any other thing
we’ve been wrong about...We’vewe’ve been wrong about...We’ve
starved people, hindered science, hurtstarved people, hindered science, hurt
the natural environment, and denied ourthe natural environment, and denied our
own practitioners a crucial tool”own practitioners a crucial tool”
Mark Lynas, Lecture to Oxford Farming Conference, 1/3/2013.
http://www.marklynas.org/2013/01/lecture-to-oxford-farming-conference-3-january-2013/
MARK LYNAS –
formerly one of the most
strident opponents of
GE crops and food
Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
“15 years after GMO crops
were first planted
commercially in the United
States, only two governments
in Sub-Saharan Africa have
given a commercial release to
any GMO crops, the Republic
of South Africa (for maize,
soybean, and cotton), and
Burkina Faso (only for cotton).”
Allows commercial
planting of biotech crops
Allows import of biotech
crops for food and/or feed
Cruz, Von Mark. V. and R.A. Hautea. 2011. Global scenario
on crop biotechnology: Communication setting. pp. 1-25.
In M.J. Navarro and R.A. Hautea (eds.) Communication
challenges and convergence in crop biodiversity. ISAAA and
SEARCA, Los Baños, Philippines. Book Chapter.
Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
““I now say that the world has the technology —I now say that the world has the technology —
either available or well advanced in the researcheither available or well advanced in the research
pipeline — to feed on a sustainable basis apipeline — to feed on a sustainable basis a
population of 10 billion people. The more pertinentpopulation of 10 billion people. The more pertinent
question today is whether farmers and ranchers willquestion today is whether farmers and ranchers will
be permitted to use this new technology? While thebe permitted to use this new technology? While the
affluent nations can certainly afford to adopt ultraaffluent nations can certainly afford to adopt ultra
low-risk positions, and pay more for food producedlow-risk positions, and pay more for food produced
by the so-called ‘organic’ methods, the one billionby the so-called ‘organic’ methods, the one billion
chronically undernourished people of the lowchronically undernourished people of the low
income, food-deficit nations cannotincome, food-deficit nations cannot.”.”
Norman Borlaug
Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
Dr. Alison Van Eenennaam - What Role Will Animal Biotechnology Play in Feeding the World?

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Dr. Alison Van Eenennaam - What Role Will Animal Biotechnology Play in Feeding the World?

  • 1. Animal Genomics and Biotechnology EducationAnimal Genomics and Biotechnology Education What role will animal biotechnology play in feeding the world? Alison Van Eenennaam Ph.D.Alison Van Eenennaam Ph.D. Cooperative Extension SpecialistCooperative Extension Specialist Animal Biotechnology and GenomicsAnimal Biotechnology and Genomics Department of Animal ScienceDepartment of Animal Science University of California, DavisUniversity of California, Davis alvaneenennaam@ucdavis.edualvaneenennaam@ucdavis.edu http://animalscience.ucdavis.edu/animalbiotechhttp://animalscience.ucdavis.edu/animalbiotech “The mission of the animal genomics and biotechnology extension program is to provide broad, science-based extension programming on the uses of animal biotechnologies in livestock production systems.”
  • 2. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education Convention on Biological Diversity: “Convention on Biological Diversity: “BiotechnologyBiotechnology isis any technological application that uses biologicalany technological application that uses biological systems, living organisms or derivatives thereof tosystems, living organisms or derivatives thereof to make or modify products or processes for specific use.”make or modify products or processes for specific use.” Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013 Genetics/breedin g Nutrition Health Artificial insemination Feed additives: Amino acids, enzymes & probiotics Molecular diagnostics Progesterone monitoring Prebiotics Recombinant vaccines Estrus synchronization Silage additives (enzymes and microbial inoculants) Conventional vaccines Invito fetilization and embryo transfer Ionophores Sterile insect technique (SIT) Molecular markers; genomic selection Single cell proteins Bioinformatics Cryopreservation Solid state fermentation of lignocellulosics Semen and embryo sexing Recombinant somatotropins GREEN = Potential for generating impact (time frame <10 years) Cloning Molecular gut microbiology Transgenesis Ortiz, Rodomiro. 2010. Agricultural Biotechnologies in Developing Countries: Options and Opportunities in Crops, Forestry, Livestock, Fisheries and Agro-Industry to Face the Challenges of Food Insecurity and Climate Change.
  • 3. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
  • 4. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education Round Oak Rag Apple Elevation (born 1965) >80,000 daughters, 2.3 million granddaughters, and 6.5 million great-granddaughters Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013 VanRaden, P.M. (2007). Improving Animals Each Generation by Selecting from the Best Gene Sources. Available: http://aipl.arsusda.gov/publish/other/2007/Duke07_pvr.pdf.
  • 5. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics EducationVan Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013 1944: 25.6 million animals; total annual milk production of 53.1 billion kg. 1997: 9.2 million animals; total annual milk production of 84.2 billion kg. About half of this 369% increase in production efficiency is attributable to genetic improvement enabled by AI VandeHaar, M.J. and St-Pierre, N. (2006). Major Advances in Nutrition: Relevance to the Sustainability of the Dairy Industry. Journal of Dairy Science 89, 1280-1291. A I
  • 6. Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013 Resource use and waste outputs from modern US dairy production systems typical of the year 2007, compared with historical US dairying (characteristic of the year 1944). GHG = Greenhouse gas
  • 7. Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013 Average annual milk yield and carbon footprint per kg milk - across global regions. Data adapted from FAO.,
  • 8. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education Current status of animal biotechnologies and factors influencing their applicability in developing countries - GENETICS Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013 Extent of use Public and government acceptance Current technical capability for using technology Infrastructure and materials and tools available for using technology Relative cost Skills required for application Potential for generating impact (time frame <10 years) ARTIFICIAL INSEMINATION ++ +++ ++ ++ ++ ++ +++ PROGESTERONE MONITORING + +++ + + ++ ++ ++ ESTRUS SYNCHRONIZATION + +++ + + ++ ++ ++ IN VITRO FERTILIZATION/ EMBRYO TRANSFER + +++ + + +++ +++ ++ MOLECULAR MARKERS + +++ + + ++ +++ + CRYOPRESERVATION + +++ ++ + ++ +++ ++ SEMEN AND EMBRYO SEXING + +++ + + +++ ++ ++ CLONING + + + + +++ +++ + TRANSGENESIS/GE 0 + + + +++ +++ +
  • 9. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
  • 10. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education GE Chickens That Don't Transmit Bird Flu Breakthrough could prevent future bird flu epidemics www.roslin.ed.ac.uk/public-interest/gm-chickenswww.roslin.ed.ac.uk/public-interest/gm-chickens Science 331:223-226. 2011 Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
  • 11. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education Omega-3 PigsOmega-3 Pigs (Pigs cloned after genetically engineering cell)(Pigs cloned after genetically engineering cell) Nature Biotechnology 24:435-436. 2006 University of Missouri/University of Missouri/Massachusetts General Hospital and Harvard Medical School Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
  • 12. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education Mastitis-resistant cowsMastitis-resistant cows (inflammation of mammary gland)(inflammation of mammary gland) Nature Biotechnology 23:445-451. 2005 www.ars.usda.govwww.ars.usda.gov Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
  • 13. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education Fast growing salmon The founder female was generated in 1989 ~ a quarter century ago Nature Biotechnology 10:176 – 181. 1992 University of Toronto/Memorial University of Newfoundland,University of Toronto/Memorial University of Newfoundland, CanadaCanadaVan Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
  • 14. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education
  • 15. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education Fish reach adult size in 16 to 18 months instead of 30 months Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
  • 16. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education Timeline of AquAdvantage regulatory process Year Event 1989 • Founder AquAdvantage fish produced in Canada 1995 • FDA review of AquAdvantage salmon begins 2001 • First regulatory study submitted by Aqua Bounty Technologies to U.S. FDA for a New Animal Drug Applications (NADA) 2009 • FDA guidance on how GE animals will be regulated • FDA approval of first GE animal pharmaceutical • Final AquAdvantage regulatory study submitted to FDA 2010 • FDA VMAC meeting on AquAdvantage salmon (9/20/10) 2011 • Political efforts to prevent FDA from regulating GE salmon 2013 • AquaBounty has expended over $60 million to bring the AquAdvantage salmon through the regulatory approval process thus far (D. Frank, CFO, AquaBounty, pers. comm.) • Still waiting for regulatory decision on AquAdvantage salmon • Delayed approvals diminishing US investment in GE animals 24+yearsfromdiscoverytoapplication? Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
  • 17. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education Sites working on GE livestock for food – 1985 North America, Europe and Australasia Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
  • 18. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education Sites working on GE livestock for food - 2012 Asia and South America are moving forward with this technology in their animal agriculture Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
  • 19. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education My basic question is thisMy basic question is this ● The first genetically engineered (GE) crops came to the market in 1986The first genetically engineered (GE) crops came to the market in 1986 ● In 2012In 2012 17.3 million17.3 million farmers grew GE crop varieties on > 170 millionfarmers grew GE crop varieties on > 170 million hectares, and of these > 90% (15 million) were small, resource-poorhectares, and of these > 90% (15 million) were small, resource-poor farmers in developing countriesfarmers in developing countries ● Humans and livestock have consumed billions of meals without a singleHumans and livestock have consumed billions of meals without a single case of harm attributable to the GE nature of the materials consumedcase of harm attributable to the GE nature of the materials consumed ● Currently products developed though the process of GE are singled outCurrently products developed though the process of GE are singled out and uniquely required to go through regulatory approvaland uniquely required to go through regulatory approval ● These regulatory policies add years and millions of dollars to the cost ofThese regulatory policies add years and millions of dollars to the cost of developing GE crops and animalsdeveloping GE crops and animals ● Is this level of scrutiny aligned to science-based risks associatedIs this level of scrutiny aligned to science-based risks associated with this technology, or is this overabundance of precautionwith this technology, or is this overabundance of precaution making the deployment of this valuable technology beyond themaking the deployment of this valuable technology beyond the means of all but the largest, multinational corporations, to themeans of all but the largest, multinational corporations, to the detriment of food security globally?detriment of food security globally? Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
  • 20. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education There is no scientific case for a blanketThere is no scientific case for a blanket approval of all uses of GE. But equally there isapproval of all uses of GE. But equally there is no scientific case for contrived safety testingno scientific case for contrived safety testing There is always the issue of novel proteins or compoundsThere is always the issue of novel proteins or compounds with no history of safe use. These will always have to bewith no history of safe use. These will always have to be tested for toxicity and allergenicity– be they introduced bytested for toxicity and allergenicity– be they introduced by GE or conventional breeding techniques.GE or conventional breeding techniques. The bulk of safety testing and expense is to detectThe bulk of safety testing and expense is to detect “unintended” changes specifically resulting from GE“unintended” changes specifically resulting from GE ItIt is continued testing using ever more-expensive techniquesis continued testing using ever more-expensive techniques including emerging “omics” for these “including emerging “omics” for these “unexpected” unintendedunexpected” unintended effects of GEeffects of GE that is scientifically dubious as the biologicalthat is scientifically dubious as the biological relevance of a statistically significant compositional change isrelevance of a statistically significant compositional change is unclear – especially in the absence of data for conventional food.unclear – especially in the absence of data for conventional food. Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
  • 21. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education GE process-based “equivalence” studies uniquely required for GE can no longer justified on the basis of scientific uncertainty Herman RA, Price WD. 2013. Unintended Compositional Changes in Genetically Modified (GM) Crops: 20 Years of Research. J Agric Food Chem. 2013 Feb 25.
  • 22. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education Unintended effects have notUnintended effects have not materializedmaterialized It seems more scientifically defensible to be able to stateIt seems more scientifically defensible to be able to state that certain likely effects (e.g. novel allergens and toxins,that certain likely effects (e.g. novel allergens and toxins, positional insertion effects) have been assessed andpositional insertion effects) have been assessed and found absent, than to admit that one did not know quitefound absent, than to admit that one did not know quite what to look for – but found it absent neverthelesswhat to look for – but found it absent nevertheless “Skeptics who remain fearful sometimes respond that “absence of evidence is not the same thing as evidence of absence”. Yet if you look for something for 15 years and fail to find it, that must surely be accepted as evidence of absence. It is not proof that risks are absent, but proving that something is absent (proving a negative) is always logically impossible*” * Paarlberg, R. 2010. GMO foods and crops: Africa's choice. New Biotechnology 27:609-613 Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
  • 23. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education It is time to reconnect the GEIt is time to reconnect the GE regulatory framework to the bestregulatory framework to the best available scienceavailable science “Historically, risks to the environment presented by crop plants are low. In these projects, we think what we need to do is to collect scientific data and understand the scientific basis for safe use of GMO products..... We are not trying to prove how risky it may be by strange imagination or by inventing some special phenomena that do not occur in nature.” Jia S, Peng Y. 2002. GMO biosafety research in China. Environ Biosafety Res. 2002 1(1):5-8. Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013 How can $60 million be warranted to bring a fast-growing fish to market, when conventional fish (and other animal) breeders routinely develop all manner of fast-growing animals that are associated with the same set of risks?
  • 24. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education • The trigger for regulatory review should be the novelty of the introduced trait (regardless of how or when it was derived), and not the process used to introduce the trait • The severity of regulatory control should be directly related to the actual, relative risk associated with the novel characteristic (phenotype) • Phenotypes with a history of safe use should be exempted from regulatory review regardless of the methods used to produce them • Regulatory frameworks should formally evaluate the reasonable and unique risks associated with the use of GE animals in agricultural systems, and weigh them against those associated with existing conventional systems, and those of inaction (i.e. postponing a regulatory decision). Perhaps more importantly these risks have to be weighed against the benefits. GE regulatory burdens are not justified by scientific evidence or experience. While regulation to ensure the safety of new technologies is necessary, in a world facing burgeoning demands on agriculture from population growth, economic growth, and climate change, overregulation is an indulgence we can ill afford. Giddings, V., Stepp, M. and M.E. Caine. 2013. Feeding the Planet in a Warming World http://www.itif.org/publications/feeding-planet-warming-world
  • 25. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education Some animal biotechnology applications, including GE animals, would seem to align with many sustainability goals including improving animal well-being – will they be permitted to do so given current regulatory policy? • Naturally polled cattle • Trypanosome resistance • Sex selection for ♀ in dairy and egg industries
  • 26. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education ““the environmental movement has donethe environmental movement has done more harm with its opposition to geneticmore harm with its opposition to genetic engineering than with any other thingengineering than with any other thing we’ve been wrong about...We’vewe’ve been wrong about...We’ve starved people, hindered science, hurtstarved people, hindered science, hurt the natural environment, and denied ourthe natural environment, and denied our own practitioners a crucial tool”own practitioners a crucial tool” Mark Lynas, Lecture to Oxford Farming Conference, 1/3/2013. http://www.marklynas.org/2013/01/lecture-to-oxford-farming-conference-3-january-2013/ MARK LYNAS – formerly one of the most strident opponents of GE crops and food Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013
  • 27.
  • 28. “15 years after GMO crops were first planted commercially in the United States, only two governments in Sub-Saharan Africa have given a commercial release to any GMO crops, the Republic of South Africa (for maize, soybean, and cotton), and Burkina Faso (only for cotton).” Allows commercial planting of biotech crops Allows import of biotech crops for food and/or feed Cruz, Von Mark. V. and R.A. Hautea. 2011. Global scenario on crop biotechnology: Communication setting. pp. 1-25. In M.J. Navarro and R.A. Hautea (eds.) Communication challenges and convergence in crop biodiversity. ISAAA and SEARCA, Los Baños, Philippines. Book Chapter.
  • 29. Animal Biotechnology and Genomics EducationAnimal Biotechnology and Genomics Education ““I now say that the world has the technology —I now say that the world has the technology — either available or well advanced in the researcheither available or well advanced in the research pipeline — to feed on a sustainable basis apipeline — to feed on a sustainable basis a population of 10 billion people. The more pertinentpopulation of 10 billion people. The more pertinent question today is whether farmers and ranchers willquestion today is whether farmers and ranchers will be permitted to use this new technology? While thebe permitted to use this new technology? While the affluent nations can certainly afford to adopt ultraaffluent nations can certainly afford to adopt ultra low-risk positions, and pay more for food producedlow-risk positions, and pay more for food produced by the so-called ‘organic’ methods, the one billionby the so-called ‘organic’ methods, the one billion chronically undernourished people of the lowchronically undernourished people of the low income, food-deficit nations cannotincome, food-deficit nations cannot.”.” Norman Borlaug Van Eenennaam NIAA 4/16/2013Van Eenennaam NIAA 4/16/2013

Notes de l'éditeur

  1. There is a trade-off associated with the rapid dissemination of genetics through populations by AI, and that is a reduction in genetic diversity. A good example of the reproductive potential of an elite dairy bull comes from a bull named Elevation, born in 1965. He had over 80,000 daughters, 2.3 million granddaughters, and 6.5 million great-granddaughters (VanRaden, 2007). Such extensive use of small numbers of sire families has reduced the genetic diversity of the Holstein population. Intense selection leads to rapid genetic improvement, but it also reduces the relative number of parents or the effective population size. Worldwide, estimates of effective population size in Holsteins range from 100-150, despite the fact there are more than 3.7 million Holstein cows enrolled in milk recording in the USA. Reduced genetic diversity can cause a reduction in mean phenotypic performance as a result of inbreeding depression. This term refers to the decrease in fitness and vigour that result from the breeding of related individuals. One of the primary concerns related to inbreeding is reduced reproduction and fertility. It has been observed that dairy cow fertility has been declining at 1% per annum for several decades. For example, daughter pregnancy rate, a measure of how quickly cows become pregnant after having a calf, declined from 33% to 23% over the period from 1960 to 2007. As with many considerations associated with sustainability, some balance needs to be reached between the inherent conflict of accelerating the rate of genetic gain by increasing the intensity of selection on superior lines of cattle, and minimizing the rate of inbreeding
  2. To put the impact of the genetic improvement enabled by AI in a sustainability perspective, consider that advances in the genetics, nutrition and management of US dairy cows over the last century have resulted in a greater than four-fold increase in milk production per cow, and a three-fold improvement in production efficiency (milk output per feed resource input; VandeHaar and St-Pierre, 2006). About half of this 369% increase in production efficiency is attributable to genetic improvement enabled by AI. As a result a much smaller population of dairy cows supplies the US market. The US dairy cattle population peaked in 1944 at an estimated 25.6 million animals with a total annual milk production of approximately 53.1 billion kg. In 1997, dairy cattle numbers had declined to 9.2 million animals and total annual production was estimated at 70.8 billion kg. The advent of frozen semen also dramatically curtailed the number of natural service dairy bulls on farms which further lessened the inputs required to produce a unit of milk (Capper et al. , 2009) The 2007 dairy industry therefore produced 84.2 billion kg of milk with a national herd containing only 9.2 million dairy cattle (and 89.0 billion kg of milk from the same number of cattle in 2011) compared with 53.0 billion kg of milk from 25.6 million head in 1944.
  3. The 2007 dairy industry therefore produced 84.2 billion kg of milk with a national herd containing only 9.2 million dairy cattle (and 89.0 billion kg of milk from the same number of cattle in 2011) compared with 53.0 billion kg of milk from 25.6 million head in 1944. In combination with advances in crop productivity over this time period, feed use per unit of milk was reduced by 77%, land use by 90%, water use by 65%, and manure production by 76% ( Figure 2 ). The carbon footprint of a kg of milk in 2007 was 63% lower than that in 1944 (1.35 kg CO 2 -eq compared to 3.66 kg CO 2 -eq), and the total dairy industry carbon footprint (with the boundary of the farm gate) was reduced by 41%, despite the substantial increase in milk production (26). NIAA 4/16/2013 Alison Van Eenennaam
  4. If environmental sustainability were the only consideration, the FAO data could provoke the conclusion that all regions should adopt North American– and Western European–style production systems, or that dairying should be focused in these areas and discouraged in less-productive regions such as sub-Saharan Africa and South Asia. However, the significant social (both status and nutritional) and economic value of dairying in less-developed regions must not be underestimated. The challenge for global dairy production is to improve productivity and optimize sustainability within each region rather than prescribe one-size-fits-all production systems or management practices Annual average milk yield per cow has increased from 1,890 kg in 1924, when USDA dairy production record keeping began, to 9,682 kg in 2011 (19), and the current record-holding cow (named Ever-Green-View My 1326) produced over 32,800 kg. Translation Genomics SMO Genomics Alison Van Eenennaam
  5. First, if biotechnologies are to be adopted they should build upon existing conventional technologies. Most biotechnologies cannot be fully exploited in livestock unless a basic level of technical capacity and infrastructure is already present. Second, biotechnologies should be integrated with other relevant components of livestock production. As demonstrated in the case studies, the application of biotechnologies should complement other components of the livestock production and marketing system to elicit the desired result. Third, the application of biotechnologies should be supported within the framework of a national livestock development programme. Potential use of biotechnologies in livestock development should be driven by the goal of tackling problems such as food insecurity and rural poverty, rather than on the desire to impose a biotechnological solution for its own sake. Fourth, it should be borne in mind that the target end users of these biotechnologies are normally resource-poor farmers with limited purchasing power, so appropriate models are needed to ensure that the eventual biotechnology products are accessible to them.
  6. While regulation to ensure the safety of new crop varieties is necessary, in a world facing burgeoning demands on agriculture from population growth, economic growth, and climate change, overregulation is an indulgence we can ill afford
  7. In addition, although there is no evidence that more food safety testing is necessary for GE crops, one can predict that a “whatever is possible should be done” policy will push for the use of omics technologies in their mandatory assessment.
  8. Whether GE livestock fit in with sustainability goals will be greatly dependent upon the BO and production system. However some GE livestock applications (e.g. disease resistance) would seem to align with many sustainability goals, such as improving animal well-being. Infectious diseases have major negative effects on poultry and livestock production, both in terms of economics and animal welfare. The costs of disease are estimated to be 35-50% of turnover in developing countries and 17% in the developed world. Improving animal health using GE has the added benefit of reducing the need for veterinary interventions and the use of antibiotics and other medicinal treatments. Efforts are underway to generate resistance in cattle which is a major problem for beef and dairy population in East Africa (Willyard, 2011). GE could also provide a humane method for sex selection in dairy and egg industries, where females provide the animal product (i.e. milk and eggs). Gene supplementation that feminizes male embryos (Smith et al. , 2009) or eliminates the production of male sperm in sires (Herrmann et al. , 1999) is technically feasible; the latter approach has the desirable outcome that the animals that are produced are not themselves GE (Fahrenkrug et al. , 2010). This change to sex-biased or sex-specific production of offspring would have the additional advantage of increasing overall efficiency of the production system (Hume et al. , 2011).
  9. Whether GE livestock fit in with sustainability goals will be greatly dependent upon the BO and production system. However some GE livestock applications (e.g. disease resistance) would seem to align with many sustainability goals, such as improving animal well-being. Infectious diseases have major negative effects on poultry and livestock production, both in terms of economics and animal welfare. The costs of disease are estimated to be 35-50% of turnover in developing countries and 17% in the developed world. Improving animal health using GE has the added benefit of reducing the need for veterinary interventions and the use of antibiotics and other medicinal treatments. Efforts are underway to generate resistance in cattle which is a major problem for beef and dairy population in East Africa (Willyard, 2011). GE could also provide a humane method for sex selection in dairy and egg industries, where females provide the animal product (i.e. milk and eggs). Gene supplementation that feminizes male embryos (Smith et al. , 2009) or eliminates the production of male sperm in sires (Herrmann et al. , 1999) is technically feasible; the latter approach has the desirable outcome that the animals that are produced are not themselves GE (Fahrenkrug et al. , 2010). This change to sex-biased or sex-specific production of offspring would have the additional advantage of increasing overall efficiency of the production system (Hume et al. , 2011).