Dr. David Edwards - Animal Biotechnology: Innovation Stifled by Inaction

BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 1
Animal Biotechnology:
Innovation Stifled by Inaction
Dave Edwards, PhD
Biotechnology Industry Organization
April 2, 2014

Ames, IA

Needs for technology in animal agriculture
Regulatory challenges
Animal biotechnology opportunities
Opponents to biotechnology
Inaction as a reaction
What are we doing about it
Conversation Today

Food Security
Animal Health
Animal Welfare
Environmental Footprint
Challenges to Address

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
BIO is…

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

Images courtesy of Elanco Animal Health
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

CornYield
(Bushels/Acre)
Open Pollination
N2 Fertilizers
Herbicides
Insecticides
Fungicides
Hybridization
Biotech Crops
USDA, National Agricultural Statistics Service: http://www.nass.usda.gov/
Impact of Technologies

MONTH XX, 2012

• 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
Coordinated Framework

Current U.S. Regulatory Context
The Coordinated Framework
• Plants and seeds
• Animal biologics
• Meat and poultry
Three regulatory agencies have oversight
for biotechnology products under existing legislation
USDA FDA EPA
Shipping Public Health ‘Pesticidal’ Substances
Plant/Animal Protection Acts Food Drug Cosmetic Act
NEPA
FIFRA
• Food and feed
• Human biologics
• Drugs
• GE animals
• Medical devices
• Plant Pesticides (PIPs)
• Herbicides
• Chemicals and
microbials

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
U.S. Regulatory Process

Genomics
Cloning
Genetic Engineering
Vaccines
Animal Biotechnology

Animal Biotechnology Applications
Genomics
–Improved Livestock Breeds
–Faster Breeding Decisions
–Quality/Trait Certification
–Animal Identification

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

Cloning Applications
Genetically elite animals

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
EU Impact on Cloning

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/genetically-
engineered-animals-frequently-asked-
questions

AquAdvantage Salmon: An Atlantic salmon that is genetically
engineered to grow more rapidly
Aquaculture Biotechnology
Cohorts of the same age
Image courtesy of AquaBounty
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

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
BSE Resistant Cows

Mastitis costs $2 billion/year
Cows that do not require antibiotics for mastitis
USDA project
Mastitis Resistant Cows

The EnviropigTM
Image courtesy of University of Guelph

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
Newer Technologies

RNAi for Disease-Resistant Livestock
FMD resistant cattle
Influenza resistant pigs
Influenza resistant chickens
Disease-resistant fish
Slide courtesy of CSIRO
$6.5 billion lost
in China alone
on H7N9
outbreak
$13 billion lost
in 2001 FMD
outbreak in
Britain
59 million
human cases
of H1N1 in U.S.
in 2009
ISA found in salmon
worldwide,
decimated Chilean
industry for several
years

Silk produced in milk can be used in high-value industrial
products
– Medical applications
Sutures
Replacement tendons or ligaments
– Manufacturing
Seat belts
Bulletproof vests
Spider Silk Goats

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

Microchromosome with human
antibody genes in cow cell
Calves carrying human antibody genes. Calves produce
specific human antibody after immunization.
Images courtesy of Sanford
Applied Biosciences
Human Antibody Production System

$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
Financial Advantage of Genetically
Engineered Animals

Animal biotechnology developers are small
No predictability in regulatory system
Public perception
Trade questions
Well funded opponents of technology
Technology at a Crossroads

…”The burning question for us all then becomes how-
and 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
Proponent Industry Perspective

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, $
Opposition intention to change market
conditions through legislation

IN
AK
HI
CA
OR
WA
ID
MT
WI
NV
UT
AZ NM
CO
ND
SD
NE
KS
OK
TX
MN
IA
MO
AR
LA
WI
IL
MI
OH
TN
MS AL
FL
GA
SC
NC
WV
MD
DE
NJ
PA
NY
ME
NH
VT
MA
RI
CT
As of 2/7/14
2014 Biotech Food Labeling Activity
IN

Stalled Innovation in Animal Agriculture
Image courtesy of Elanco Animal Health

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
2010 FDA VMAC meeting on AquAdvantage® salmon (9/20/10)-’as safe as food from conventional Atlantic salmon’
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
[1] Chart from Alison van Eenennaam, University of California-Davis
It has been 1291 days since VMAC meeting

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
Technology Moving Overseas

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

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
41

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
Conclusions

“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.

Dave Edwards, PhD
– Director, Animal Biotechnology
– dedwards@bio.org
– P: +1(202)962-9200
http://www.bio.org/livestockbiotechsummit
Contact Information
September 16-18, 2014 in Sioux Falls, SD

Dr. David Edwards - Animal Biotechnology: Innovation Stifled by Inaction

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