Labeling Genetically Engineered Foods: Current Legislation

Labeling Genetically Engineered Foods: Current Legislation

Updated July 18, 2016
Labeling Genetically Engineered Foods: Current Legislation
Most Recent Senate Labeling Bill
modified through in vitro recombinant DNA techniques and
On June 23, 2016, the chairman and ranking Member of the
for which the modification could not occur naturally or be
Senate Agriculture Committee proposed a bill (S.Amdt.
developed through conventional plant breeding techniques.
4937 to S. 764) that would amend the Agricultural
This definition is narrower, for example, than the one
Marketing Act of 1946 to give the U.S. Department of
developed by Codex Alimentarius of the United Nations
Agriculture (USDA) authority to establish a mandatory
Food and Agricultural Organization that establishes
“national bioengineered food disclosure standard.” S. 764
internationally recognized food standards. The Codex
would authorize food manufacturers to adopt either text, a
definition includes in vitro recombinant DNA techniques in
symbol, or an electronic/digital link for identifying
its definition but also other techniques of genetic
bioengineered foods. Small food manufacturers would be
engineering.
permitted to use a website or phone number. Very small
The bill leaves to USDA the discretion to determine what
food manufacturers and restaurants would be exempt from
level of genetically engineered ingredients in a food product
the mandatory disclosure requirement. The bill is seen as a
would trigger the mandatory disclosure requirement. Unlike
compromise between earlier House and Senate bills that
other countries (e.g., Japan, Australia, European Union), the
would have authorized a national voluntary labeling
United States has not determined a level of GE material that
standard. The Senate passed the labeling bill on July 7, 63-
would trigger a labeling requirement. Depending upon the
30. The House approved the Senate bill on July 14, 306-
level of GE material in the food, some opponents have
117. President Obama has stated that he would sign it.
claimed that GE foods could be exempt from the disclosure
Some supporters of the bill remain convinced that a
requirement (e.g., foods made with GE beet sugar, corn, or
mandatory disclosure implies that genetically engineered
soy oil).
foods are potentially unsafe and that labeling is inconsistent
with the science that has demonstrated no risks to health.
FDA and USDA Comments on the Senate Bill
The Food and Drug Administration (FDA) has repeatedly
In technical comments on the bill, FDA indicated its
stated that, in the absence of a scientifically determined
concern that implementing the mandatory disclosure under
health effect or change in nutritional quality caused by the
USDA regulations could conflict with FDA’s labeling
genetically engineered (GE) material, a food does not
requirements. The bill permits information on GE content
require a label simply because it was created through GE
in a food product to be indicated through an electronic
techniques. These supporters would prefer the voluntary
format rather than on the package label. FDA regulations
labeling standard proposed in earlier labeling bills (see
require disclosure on the food package.
below).
FDA also noted the narrowness of the “bioengineering”
As with several previous labeling bills, the current bill
definition and stated their concern that the definition could
preempts the implementation of Vermont’s mandatory
limit the scope of coverage to foods that “could not
labeling law, which took effect July 1, 2016, and prohibits
otherwise be obtained through conventional breeding or
other states from developing their own labeling bills. In
found in nature.” FDA noted that this criterion was unclear
criticizing the bill, opponents have pointed to the absence of
and would be difficult to demonstrate. FDA further noted
any penalties for violating mandatory disclosure
that bill language regarding exceptions and inclusions was
requirements and the potential disparate effects of digital
unclear. FDA, however, stated that it would defer to USDA
labeling on rural, low-income, and elderly populations who
on its interpretation of the bill because USDA would be the
may lack access to smartphones or adequate digital network
implementing agency.
coverage.
In response to FDA’s technical comments on the bill,
The bill authorizes USDA to conduct a study within a year
Ranking Member Senator Stabenow asked the USDA
of enactment that would identify potential technological
general counsel to address the scope and applicability of the
factors that might affect consumer access to disclosure
proposed GE labeling bill. Counsel responded in a June 29
through electronic or digital methods. The required study
letter stating that the definition of “bioengineered” provides
would specifically address the availability of wireless or
the authority to include all the commercial GE crops used in
cellular networks, availability of landline telephones in
food manufacture in the disclosure requirement. Counsel
stores, and particular factors that might affect small retailers
also stated that novel GE techniques (e.g., gene editing such
and rural retailers.
as CRISPR) would be included in the definition if these
techniques were used to produce plants or seeds with traits
Some opponents have pointed out that the bill’s definition
of “bioengineered food”
that could not be created with conventional breeding
(§291(1)) could be interpreted so
techniques. The “bioengineering” definition would also
narrowly as to exclude some foods made with newer
include RNAi techniques, most recently applied to a non-
recombinant DNA techniques. The bill defines a
browning apple and potato.
bioengineered food as one that contains genetic material
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Labeling Genetically Engineered Foods: Current Legislation
On the issue of whether refined oils and sugars produced or
foods in any meaningful way or that, as a class, foods
developed from GE techniques could be excluded from the
developed by GE techniques presented any different or
mandatory disclosure requirement, USDA stated that
greater safety concern than foods developed by traditional
Section 291(1) provides authority to include foods that may
plant breeding. FDA concluded that the method used to
or may not contain such products in the disclosure
develop a new plant variety, including the use of GE
requirement. However, counsel further stated that, “as a
technologies, is generally not regarded as “material.”
practical matter,” USDA would look not only at the
definition of “bioengineering” but would also consider the
Under the 1986 Coordinated Framework for Regulation of
Biotechnology, FDA is responsible for reviewing GE plants
authority provided in the establishment of the national
and animals and foods derived from them for their safety
bioengineered food disclosure standard (§293(b)(2)(B) and
for human and animal consumption. FDA does not require
§293(b)(2)(C)) with respect to the amount of a GE
that the food be labeled based solely on the method used to
substance present in the food, as well as other factors that
might deem the product as a “bioengineered food.”
produce it. Only where disclosure of the fact that a food is

derived from a GE organism was necessary to protect
Earlier Labeling Bills
public health or safety would FDA, under current law,
An earlier Senate bill (S. 2609) would also have amended
require a label to that effect.
the Agricultural Marketing Act of 1946 to require USDA
Under its 1992 guidelines, FDA permits voluntary labeling
establish a new voluntary framework governing the use of
of foods that have or have not been derived from GE plants.
labels claiming either the absence or use of GE foods or
Many food companies currently label their foods to indicate
food ingredients. The bill did not pass a cloture vote in
that they do not contain GE ingredients. As long as such
March. Separately, the House passed H.R. 1599 in July
voluntary labels are neither false nor misleading, they are
2015. It would also create a new voluntary labeling
lawful under the FFDCA. However, no systematic national
framework by amending the Federal Food, Drug, and
standard for voluntary GE labeling exists other than the
Cosmetic Act (FFDCA) and amending the Agricultural
FFDCA prohibition against false or misleading claims. One
Marketing Act of 1946 to create a Genetic Engineering
standardized exception in current use is the National
Certification process under USDA. Both bills would
Organic Program (NOP) label that indicates that a food
preempt any state or political subdivision of a state from
product is produced under NOP standards, which prohibit
establishing its own labeling law for foods containing GE
the use of GE ingredients.
material that differed from federal requirements.
State Labeling Laws
The earlier Senate bill would have given USDA
In 2014, Vermont became the first state to pass a mandatory
discretionary authority to establish labeling standards but,
GE labeling law that became effective on July 1, 2016.
like the House-passed bill, would have prohibited language
Connecticut and Maine also passed mandatory GE labeling
expressing or implying a higher quality or safer food based
laws in 2013 and 2014, respectively, but they will not go
on whether the food was developed though GE
into effect until five contiguous states also pass mandatory
technologies.
GE labeling laws. Other state legislatures (e.g., New Jersey,
Alaska, Hawaii, Iowa, Illinois, Massachusetts) are also
Several other bills requiring mandatory labeling of GE
considering mandatory labeling laws. Some states (e.g.,
foods have been proposed in Congress but have not been
Michigan, North Dakota) have also enacted legislation
considered by any committees. The Biotechnology Food
urging the U.S. Congress to pass a uniform labeling
Labeling Uniformity Act (S. 2621) would amend the
standard. California, Colorado, and Washington had
FFDCA to require that a food contain a label or symbol on
mandatory labeling ballot initiatives in recent years. Each
a Nutrition Facts panel indicating that the food was
was defeated.
produced by or derived from GE ingredients and would
preempt state labeling laws. Other legislation would amend
Opponents of labeling argue that there are no scientific
the FFDCA to require labeling GE salmon (Genetically
reasons to require mandatory labeling of a GE food product.
Engineered Salmon Risk Reduction Act, S. 738) or any
Labeling opponents have feared that in the absence of a
genetically engineered fish (H.R. 393). The Genetically
national labeling law, each state could pass its own specific
Engineered Food Right-to-Know Act (H.R. 913/S. 511)
labeling requirements for GE foods, requiring costly
would amend the FFDCA to classify a food as misbranded
management changes in commodity supply chains to
if it does not contain a label indicating that GE materials
comply with different state laws. Proponents of labeling
were used in its production.
strongly support a mandatory labeling standard, citing the
consumers’ right to know. Continued opposition to the
Labeling Under the FFDCA
Senate labeling bill is expected to move to USDA’s
The FFDCA prohibits interstate commerce of any food that
rulemaking process.
is misbranded. A food is misbranded if its labeling is false
or misleading. A label is misleading if, among other things,
For more information, see CRS Report RL32809,
it fails to reveal facts that are “material” regarding
Agricultural Biotechnology: Background, Regulation, and
representations made or suggested in the labeling or
Policy Issues; andCRS Report R43705, Legal Issues with
“material” with respect to consequences that could result
Federal Labeling of Genetically Engineered Food: In Brief.
from the use of the food.
Tadlock Cowan, Analyst in Natural Resources and Rural
In its 1992 Statement of Policy: Foods Derived from New
Development
Plant Varieties, FDA stated that it was not aware of any
information showing that GE foods differed from other
IF10376
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Labeling Genetically Engineered Foods: Current Legislation

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