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38 Regulation 2 (2015-2016)

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2 /Regulation /SPRING 2015


Concerns about Federal

GMO Food Legislation


n their article Mandatory Food Label-
    ing for GMOs (Winter 2014-2015),
    Thomas Hemphill and Syagnik Baner-
jee mentioned proposed federal legislation
intended to circumvent differing state man-
dates on the labeling of foods containing
genetically modified organisms (GMOs).
The bill, H.R. 4432, is better known as the
CFSAF bill or the Pompeo bill after its lead
sponsor, Rep. Mike Pompeo (R-Kansas).
   Pompeo and his co-sponsors have good
intentions for the bill, trying to expand
the use of genetic engineering. But we
have serious concerns about the bill, as we
explained in our recent Forbes.com op-ed,
A Faustian Bargain on Labeling Geneti-
cally Engineered Food (Feb. 25, 2015).
Here, we briefly summarize our concerns.
   The bill is the product of lobbying by the
Coalition for Safe Affordable Food (CFSAF),
a group that represents food companies and
farm organizations. The bill has four goals:

* Eliminate confusion and uncer-
  tainty from the prospects of a 50-state
  patchwork of safety and labeling
  laws for genetically engineered food,
  by affirming that the U.S. Food and
  Drug Administration is the definitive
  national authority.
* Require the FDA to conduct a safety
  review of all new genetically engineered
  traits before they are introduced into
  commerce.
* Direct the FDA to establish federal
  standards for companies that want to
  label their product voluntarily to indi-
  cate the absence or presence of food
  ingredients produced with molecular
  genetic engineering techniques.
* Direct the FDA to define the term
  natural for use on food and beverage
  products so that food and beverage com-
  panies and consumers have a consistent
  legal framework that will guide food
  labels and inform consumer choice.


FDA preemption/ With respect to the first
goal, we agree that Congress should explic-
itly preempt state and local GMO safety
and labeling laws. Such laws are inherently
misleading because they wrongly imply
that genetically engineered ingredients
belong to a category of substances that
are less safe or nutritious than natural
substances. The use of genetic engineer-
ing does not make the resulting food any
less (or more) healthy or safe-unless the
GMO was engineered to be so. As federal
regulators have said repeatedly, labeling to
identify food derived from plants modi-
fied with the newest techniques of genetic
engineering would erroneously imply a
meaningful difference where none exists.
   In an ideal world, Congress could pass
legislation to affirm that the FDA is the
sole authority to require mandatory label-
ing and that, as the FDA announced in a
1992 policy statement, labeling is appro-
priate when it conveys material informa-
tion that bears on safety or usage. As the
FDA stated at the time, risk-related factors
in the context ofnovel foods could include
the presence of a completely new substance
in the food supply, an increase in the level
of a natural food toxin, significant changes
in the level of a macronutrient, or the pres-
ence of a potent allergen where a consumer
would not expect to encounter it.

GMO review/ We disagree strongly with
the creation of a new requirement that
the FDA conduct a safety review of all
new GMOs before they are introduced
into commerce. Laboratory research on
plants has been robust since the inven-
tion of molecular genetic engineering
techniques in the early 1970s, but the
commercialization of GMO products
has been slowed by unscientific, excessive
government regulation that discriminates
against modern, molecular genetic engi-
neering techniques. For a quarter-century,


generically engineered crops have been the
most scrutinized products in human his-
tory, yet there is no scientific justification
for such a burden. GMOs are far more
precisely and predictably crafted than
their natural predecessors, and none has
caused documented harm to a person or
disruption to an ecosystem.
   Hundreds of risk-assessment experi-
ments as well as innumerable observations
of real-world use have confirmed the
safety of genetic modification technology.
In spite of this vast amount of evidence,
there has been no reduction or rationaliza-
tion of the regulatory burden placed on
plants made by the newer techniques of
genetic engineering. In many cases, regu-
latory stringency and burdens are actually
increasing, sometimes in the naive hope
that this will reassure skeptics.
   This provision of the legislation would
represent yet another escalation of regu-
lation without any justification for it-
except perhaps as a bargaining chip for the
creation of explicit prohibitions against
state and local regulation. That is not a
sufficient justification.
   At present, the FDA operates a volun-
tary consultation program for genetically
engineered foods whereby the developer
provides the agency various information
about the product. Published reports indi-
cate that developers have, without excep-
tion, submitted to this voluntary con-
sultation and it appears to be more than
adequate to protect American consumers.
   There is a broad consensus that there
is no scientific reason to regard food made
with modern molecular techniques as dif-
ferent from other food. Corn modified to
be pest-, disease-, or herbicide- resistant
is still corn regardless of the breeding
method used to introduce or enhance the
trait. Therefore, even the voluntary con-
sultation-which no food producer would
dare to flout-is gratuitous and excessive.
Virtually identical foods made with older,
less precise, and less predictable techniques
are not routinely subject to review, volun-
tary or otherwise.
   Another concern is that a required FDA
review and approval of new genetically engi-

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