Feeding, Fueling, Healing

• Author: Michael Wach
• Position: Managing Director of Science and Regulatory Affairs for Food and Agriculture at the Biotechnology Industry Organization in Washington, D.C.
• Pages: 41-41

MARCH/APRIL 2009 ❧ Page 41

Copyright © 2009, Environmental Law Institute®, Washington, D.C. www.eli.org.

Reprinted by permission from The Environmental Forum®, Match/April 2009

anoTher view

voluntary consultation process where-

by developers can show the agency

their food safety data so it can identify

any def‌iciencies. While such regula-

tion is welcomed by developers (they

get to avoid the lengthy food-additive

approval process), it puts the burden

on the agency to f‌ind a product po-

tentially unsafe before it can prevent

its introduction into the food supply.

It also results in the public relying on

the industry’s self-interested safety de-

termination, instead of an FDA inde-

pendent safety assessment. In contrast,

every other country with a functional

biosafety regulatory system mandates

a government approval before a GE

crop is marketed. It is also ironic that

GE crops need formal approval to be

planted outdoors (see below) but no

formal approval to enter the food sup-

ply. at result is not a policy decision

that GE crops are more dangerous to

the environment than they are to eat,

but solely because the government is

trying to f‌it products made using a

new technology into an old regulatory

scheme not designed for such applica-

tions.

Engineered food crops that pro-

duce pharmaceuticals also avoid food

regulations at FDA because the law’s

def‌inition of food is something in-

tended to be eaten by humans or ani-

mals. If a developer does not intend

its GE biopharming crop to enter

the food supply, then FDA has no

jurisdiction until and if that crop in-

advertently ends up in the food sup-

ply (but everyone knows accidents do

happen).

FDA announced last September

that it will regulate GE animals as

“new animal drugs,” which requires

FDA approval before companies can

market those animals and their prod-

ucts. While GE animals clearly are not

similar to conventional animal drugs

and the public will not understand

why they are being treated like drugs,

applying those legal provisions does

ensure a mandatory pre-market ap-

proval process intended to safeguard

the animals’ welfare along with any

food from those animals. e down-

Feeding, Fueling, Healing

Michael Wach

All of these societal benef‌its can

be realized with next-generation

biotechnologies. But they must f‌irst

work their way through a complex,

rigorous regulatory system.

Rules must keep pace with the

technology they regulate. But years

of experience with the successful

and safe deployment of biotech-

nology indicate that the amount of

regulatory oversight in the United

States is adequate. U.S.-developed

biotech products are so well adopt-

ed precisely because our regulatory

system results in safe, high-quality

products.

e fact is, products derived

from biotechnology have been

consumed by billions of people

for more than 15 years

without a single docu-

mented health prob-

lem. is is a remark-

able safety record, but

not surprising, given

the pre-market exami-

nation and testing of

biotech products.

In spite of the years

of costly research needed to bring

these products to market, develop-

ers want the regulatory scrutiny that

provides safety for humans and the

environment. e reality of mod-

ern agriculture dictates that this

scrutiny makes not for just good

science, but also good business.

oughtful commercial devel-

opment, with appropriate regula-

tory oversight, is the best way to

continue to bring these valuable

products to market, well into the

future. Now more than ever, we

should embrace the technologies

that help us be better stewards of

the land, while feeding, fueling,

and healing our growing world.

Dr. Michael Wach is Managing Director

of Science and Regulatory Affairs for Food

and A griculture at the Biotechnolog y In-

dustry Or ganization in Washington, D.C.

Since biotech products

were f‌irst commercial-

ized in 1996, the world

has embraced this sci-

ence because of the

proven benef‌its it delivers to grow-

ers and consumers. More than 12

million farmers in 23 countries are

using agricultural biotechnology

today. In other words, ag biotech is

agriculture.

Biotech crops help farmers grow

heartier and healthier food. A ge-

netically enhanced virus-resistant

papaya literally saved the Hawai-

ian industry for farmers who suf-

fered devastating losses from a pest.

Biotechnology also benef‌its the en-

vironment. Because biotech crops

require less cultivation

and fewer pesticide ap-

plications, farmers save

fuel and reduce carbon

dioxide emissions.

As we look to the fu-

ture, we see the promise

of crops that are more

tolerant of drought and

f‌looding and crops that

use soil nutrients more ef‌f‌iciently.

Foods can also be fortif‌ied with

more nutrients.

Although animal biotechnol-

ogy is a much younger segment of

this dynamic industry, its promises

are equally compelling, and soci-

ety is just beginning to learn of its

benef‌its. Research with genetically

engineered animals has yielded a va-

riety of breakthroughs that can help

advance human health, enhance

food production, mitigate environ-

mental impact, and optimize animal

welfare. In January, the Food and

Drug Administration issued the f‌irst

regulatory guidance governing GE

animals. is system ensures the

products made available through

this science will go through a rigor-

ous and transparent review process

before being approved for the mar-

ketplace.