Animal Biotechnology:
Innovation Stifled by Inaction
Dave Edwards, PhD
Biotechnology Industry Organization
April 2, 2014
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Ames, IA
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Conversation Today
Needs for technology in animal agriculture
Regulatory challenges
Animal biotechnology opportunities
Opponents to biotechnology
Inaction as a reaction
What are we doing about it
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Challenges to Address
Food Security
Animal Health
Animal Welfare
Environmental Footprint
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BIO is…
Working to Heal, Fuel, and Feed the World
World’s largest biotechnology trade association
– 1100 companies, academic centers, state and regional
affiliates, and related organizations
R&D of technologies
– Human Health
– Industrial & Environmental
– Food and Agriculture
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Technology is Crucial
Over the next 50 years, the world’s farmers
and ranchers will be called upon to produce
more food than has been produced in the past
10,000 years combined, and to do so in
environmentally sustainable ways.
-Jacques Diouf, FAO Director General, 2007
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Technology is Crucial
Seventy percent of the world’s additional food needs can be
produced only with new and existing agricultural technologies.
-United Nations FAO, 2002
Images courtesy of Elanco Animal Health
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Impact of Technologies
Fungicides
(Bushels/Acre)
Corn Yield
Biotech Crops
Insecticides
Herbicides
N2 Fertilizers
Hybridization
Open Pollination
USDA, National Agricultural Statistics Service: http://www.nass.usda.gov/
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MONTH XX, 2012
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Coordinated Framework
•
Federal “Safety Net”
• All products subject to science-based regulation under existing,
product-based statutes
• Individual products or categories eligible for exemption over
time based on experience and data
• Same “precautionary approach” applied under other health,
safety and environmental statutes
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Current U.S. Regulatory Context
The Coordinated Framework
Three regulatory agencies have oversight
for biotechnology products under existing legislation
USDA
•
•
•
FDA
Plants and seeds
Animal biologics
Meat and poultry
•
•
•
•
•
Food and feed
Human biologics
Drugs
GE animals
Medical devices
EPA
•
•
•
Plant Pesticides (PIPs)
Herbicides
Chemicals and
microbials
Shipping
Public Health
‘Pesticidal’ Substances
Plant/Animal Protection Acts
Food Drug Cosmetic Act
FIFRA
NEPA
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U.S. Regulatory Process
BIO and its members support the science-based regulatory
process in the US as laid out by FDA Guidance for Industry 187
Political interference in the process means that these innovations
in food and medicine cannot help public health, the environment,
or with sustainability
Process should allow innovative products to come to market once
approved for safety and efficacy through a scientific review
Market should decide acceptance of technology
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Animal Biotechnology
Genomics
Cloning
Genetic Engineering
Vaccines
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Animal Biotechnology Applications
Genomics
–Improved Livestock Breeds
–Faster Breeding Decisions
–Quality/Trait Certification
–Animal Identification
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Animal Biotechnology Applications
Cloning
–Risk Assessments-Safe as non-cloned food
US FDA (2008), EFSA (2008, 2009, 2010, 2012)
Japan, New Zealand, Argentina, China
–Utilized as a vital tool in development of
genetically engineered animals
–Like-minded agreement to not restrict trade
Argentina, Brazil, New Zealand, U.S., Uruguay
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Cloning Applications
Genetically elite animals
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EU Impact on Cloning
Current EU Commission proposal
– Ban cloning for food production for next 5 years
– Label food from clones
– Further analysis of labeling beef from clone offspring
– Not restrict embryos and semen from clones
EU Parliament statements
– Full ban on clones and offspring
– Ban imported clones and offspring, or at least label
Precautionary Principle at play
– EU wants ban so cloning process can improve-counterintuitive
– EFSA reports food is safe (2008, 2009, 2010, and 2012)
– Some have issue with ethics, welfare of cloning
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Animal Biotechnology Applications
Opportunities to impact
–Food availability, cost, & production
–Biomedical research, treatments, &
production
BIO report, “Genetically Engineered Animals and Public Health”
available from
http://www.bio.org/articles/geneticallyengineered-animals-frequently-askedquestions
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Aquaculture Biotechnology
AquAdvantage Salmon: An Atlantic salmon that is genetically
engineered to grow more rapidly
Environmental
Impact of Importing
Salmon
Fly halfway around world
1847 fully loaded 747’s
=
66,359,178 gallons of
fuel
=
94,799 cars per year
Cohorts of the same age
Image courtesy of AquaBounty
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BSE Resistant Cows
Do not make prion, but remain healthy
$4.7 billion in losses to U.S. beef industry in 2004 from BSE case
Prion and antibody free bovine sera and reagents for cell culture development
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Mastitis Resistant Cows
Mastitis costs $2 billion/year
Cows that do not require antibiotics for mastitis
USDA project
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The EnviropigTM
Image courtesy of University of Guelph
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Newer Technologies
Gene editing
– Make single changes to DNA
– Turn horned cattle gene to polled
RNA interference
– Small segments of RNA keep genes from being expressed
– 2006 Nobel Prize
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RNAi for Disease-Resistant Livestock
$6.5 billion lost
in China alone
on H7N9
outbreak
Influenza resistant chickens
59 million
human cases
of H1N1 in U.S.
in 2009
Influenza resistant pigs
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$13 billion lost
in 2001 FMD
outbreak in
Britain
FMD resistant cattle
ISA found in salmon
worldwide,
decimated Chilean
industry
for several
Disease-resistant fish
years
Slide courtesy of CSIRO
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Spider Silk Goats
Silk produced in milk can be used in high-value industrial
products
– Medical applications
Sutures
Replacement tendons or ligaments
– Manufacturing
Seat belts
Bulletproof vests
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GE Livestock Models
Current Models
–Cystic Fibrosis
–Liver Disease
–Heart Disease
–Cardiac Arrhythmia
–Cancer
–Neurological
–Muscular Dystrophy
EU, US, and worldwide
Slide courtesy of Exemplar Genetics
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Human Antibody Production System
Calves carrying human antibody genes. Calves produce Microchromosome with human
antibody genes in cow cell
specific human antibody after immunization.
Images courtesy of Sanford
Applied Biosciences
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Financial Advantage of Genetically
Engineered Animals
$600 million to
build/operate
$3 million to
build/operate
This protein can be produced at either of these facilities in the
same amounts. It represents a $200 million/year product in
the pharmaceutical industry
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Technology at a Crossroads
Animal biotechnology developers are small
No predictability in regulatory system
Public perception
Trade questions
Well funded opponents of technology
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Proponent Industry Perspective
…”The burning question for us all then becomes howand how quickly-can we move healthy, organic
products from a 4.2% market niche, to the dominant
force in American food and farming? The first step is
to change our labeling laws…” OCA 08/02/12
“We are going to force them to label this food. If we
have it labeled, then we can organize people not to
buy it.” Center for Food Safety
“Personally, I believe GM foods must be banned
entirely, but labeling is the most efficient way to
achieve this.” Mercola.com
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Opposition intention to change market
conditions through legislation
Eliminate/prejudice biotech food
Undermine consumer confidence in food
safety
Undermine value chain confidence in demand
for GE ingredients
Increase market share organic/non-GM, $
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2014 Biotech Food Labeling Activity
As of 2/7/14
NH
VT
WA
MT
ND
MN
OR
ID
WI
SD
MI
WI
OH
NV
IL
UT
CO
KS
NY
PA
IA
NE
CA
ME
MA
IN
IN
WV
MO
RI
CT
NJ
DE
NC
TN
AK
AZ
OK
NM
MD
SC
AR
MS
AL
GA
LA
TX
FL
HI
Stalled Innovation in Animal Agriculture
Image courtesy of Elanco Animal Health
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Regulatory Inaction
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 Application
2009
FDA guidance on how GE animals will be regulated
FDA approval of first GE animal pharmaceutical
Final AquAdvantage® regulatory study submitted to FDA
FDA VMAC meeting on AquAdvantage® salmon (9/20/10)-’as safe as food from conventional Atlantic salmon’
2010
2011-2014
Political efforts to prevent FDA from regulating GE salmon, ban GE salmon, delay regulatory approval
2012
FDA released finding of no significant impact “FONSI” environmental assessment
2014
Still waiting for regulatory decision on AquAdvantage® salmon
It has been 1291 days since VMAC meeting
[1]
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Chart from Alison van Eenennaam, University of California-Davis
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Technology Moving Overseas
China-investing $12 billion in agriculture biotechnology
– Over 50 different animal lines developed
Brazil-recruiting U.S. researchers
– Supportive environment for development and deployment
EU-biomedical research on livestock growing
– Have put together a regulatory regime for GE animals
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Acknowledge Current Business
Climate/Skepticism
 We have great stories that are not being heard
because we are not believed
 Instead of repeating these messages, we
committed to showing our audiences that we have
nothing to hide
 Only when our audiences understand we are
listening to them will they begin to listen to us
www.gmoanswers.com
Strong digital and social presence in which people
hang out and engage
Website Traffic
• Facebook and Twitter top drivers
• More than 150,000 visits and 600,000 page views
• Currently 25,000 visitors /month
• Average duration of visit is 5 minutes
• 35% are returning visitors
40
More balanced media coverage in which our
stories are told accurately
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Conclusions
Innovations from biotechnology will positively
impact the future of food production
The biotechnology industry seeks to work in
partnership with the value chain
–Providing timely and useful information
–Working for public understanding and confidence
–Overcome inaction from overabundance of
precaution
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“Not one person has suffered negative
effects from innovations like GMOs, yet
25,000 people die every day from
malnutrition.”
- Dr. Norman Borlaug, 2009
Limiting innovation due to imagined possibilities and the
Precautionary Principle has negative ramifications for us all.
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Contact Information
Dave Edwards, PhD
– Director, Animal Biotechnology
– dedwards@bio.org
– P: +1(202)962-9200
http://www.bio.org/livestockbiotechsummit
September 16-18, 2014 in Sioux Falls, SD
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