A new law targeted at GMO food labeling instructs the Secretary
of Agriculture to establish standards for identifying
"bioengineered" food. While many might think
CRISPR-modified foods will be covered by such a law, certain CRISPR
technologies could escape labeling requirements.
The law also provides that "a bioengineered food that has
successfully completed the pre-market Federal regulatory review
process shall not be treated as safer than, or not as safe as, a
non-bioengineered counterpart of the food solely because the food
Thus, the law will create a national, mandatory requirement for
labeling GMO food.
The Scope of "Bioengineered" Foods
The law defines the term "bioengineering" and similar
terms used with respect to a food to refer to a food:
that contains genetic material that
has been modified through in vitro recombinant
deoxyribonucleic acid (DNA) techniques; and
for which the modification could not
otherwise be obtained through conventional breeding or found in
The law directs the Secretary to "determine the amounts of
a bioengineered substance that may be present in food, as
appropriate, in order for the food to be a bioengineered
The law prohibits categorizing "food derived from an
animal" as a "bioengineered" food "solely
because the animal consumed feed produced from, containing, or
consisting of a bioengineered substance."
Does The GMO Food Labeling Law Apply to CRISPR?
The first CRISPR-edited food to obtain FDA approval is the CRISPR/Cas9 edited mushroom that resists
browning when exposed to air. This product is made by using a
bacterial plasmid construct to deliver a guide RNA and Cas9 enzyme
into mushroom cells and achieve the necessary deletions. The final
product does not contain any foreign DNA, such as DNA from a donor
or vector organism.
You describe your Crispr/Cas9-edited
mushroom as a having small deletions (1–14bp) in a specific
polyphenol oxidase gene but containing no foreign DNA integrated
into the mushroom genome.... [The] Animal and Plant Health
Inspection Service does not consider Crispr/Cas9-eited white button
mushrooms ... to be regulated.
That is, the USDA determined that CRISPR-edited mushrooms are
not genetically modified organisms under then-current regulations
because they do not contain any foreign DNA.
Under the new law,CRISPR-edited mushrooms could fall under the
definition of "bioengineered" since they contain
"genetic material that has been modified through in
vitro recombinant deoxyribonucleic acid (DNA)
techniques." Thus, the new law captures a broader range of
genetically modified organisms. However, to be classified as
"bioengineered," that law provides that "the
modification could not otherwise be obtained through conventional
breeding or found in nature."
The specific deletion found in the CRISPR-edited mushrooms is
similar to a mutation made in apples using gene silencing to obtain
non-browning apples, and to mutations made in apples through
conventional mutagenesis. Since conventional mutagenesis offers a
way to accelerate natural processes, it may be regarded a
"conventional" breeding process. Thus, it is possible
that the CRISPR-edited mushrooms will fall outside the new law if
the deletion is determined to be one that "could be obtained
through conventional breeding or found in nature." If that is
the case, CRISPR-edited mushrooms might not have to comply with the
new GMO food labeling requirements.
Detecting CRISPR Editing
A separate problem for regulators may be how to identify food
that has been engineered by CRISPR technologies. Conventional
genetically modified organisms, such as Bt-corn, contain
foreign DNA that can be used to identify even minute levels of the
GMO product. Since CRISPR involves genetic deletions,
CRISPR-edited organisms do not contain foreign DNA that can be used
as an identifying marker. Even if CRISPR modification is suspected,
it is difficult to screen products for specific deletions, and even
more so if the specific deletion is not known. Thus, the
effectiveness of this law may depend on voluntary compliance.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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