biotechnology industry organization animal biotechnology: innovation stifled by inaction april 2,...

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 SecurityAnimal HealthAnimal WelfareEnvironmental 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


Cor

n Y

ield

(B

ush

els

/Acr

e)

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

http://www.ers.usda.gov/Data/BiotechCrops/d_link.htm


• 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 ContextThe 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 187Political 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 reviewMarket should decide acceptance of technology

U.S. Regulatory Process


GenomicsCloningGenetic EngineeringVaccines

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 tradeArgentina, 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 clonesEU Parliament statements– Full ban on clones and offspring– Ban imported clones and offspring, or at least labelPrecautionary 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 casePrion and antibody free bovine sera and reagents for cell culture development

BSE Resistant Cows


Mastitis costs $2 billion/yearCows that do not require antibiotics for mastitisUSDA project

Mastitis Resistant Cows

FrozenFrozen


The EnviropigTM

Image courtesy of University of Guelph

Frozen


Gene editing– Make single changes to DNA– Turn horned cattle gene to polledRNA 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

SuturesReplacement tendons or ligaments

– ManufacturingSeat beltsBulletproof vests

Spider Silk Goats


GE Livestock Models

Current Models– Cystic Fibrosis– Liver Disease– Heart Disease– Cardiac Arrhythmia– Cancer– Neurological– Muscular DystrophyEU, US, and worldwide

Slide courtesy of Exemplar Genetics


Microchromosome with humanantibody 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 smallNo predictability in regulatory systemPublic perceptionTrade questionsWell 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

KY

MI

OH

TN

MS AL

FL

GA

SC

NC

VA

WV

MD

DE

NJ

PA

NY

MENH

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

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

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– [email protected]– P: +1(202)962-9200

http://www.bio.org/livestockbiotechsummit

Contact Information

September 16-18, 2014 in Sioux Falls, SD

biotechnology industry organization animal biotechnology: innovation stifled by inaction april 2,...

Documents

biotechnology inaction

address slide

framework slide

ia slide

impact of technologies

crop acreage slide

inaction dave edwards

percent of corn