Agricultural Biotechnology Education and Outreach Initiative - Experimental Study to Test the Efficacy of Educational Materials (CFSAN)

OMB No. 0910 - 0865

Expiration Date: 02/28/2022

f e e d yo u r m i n d

How GMOS Are
Regulated for Food
and Plant Safety in
the United States
Three federal agencies within the U.S.
government work together to regulate
most GMOs. “GMO” (genetically
modified organism) has become the
common term consumers and popular
media use to describe a plant, animal,
or microorganism that has had its
genetic material (DNA) altered through a
process called genetic engineering. The
U.S. Food and Drug Administration
(FDA), U.S. Environmental Protection
Agency (EPA), and U.S. Department of
Agriculture (USDA) ensure that GMOs
are safe for human, plant, and animal
health. These agencies also monitor the
impact of GMOs on the environment.

The Coordinated Framework for the
Regulation of Biotechnology,1 established
in 1986, describes how the agencies
work together to regulate GMOs.

FDA

EPA
USDA

U.S. Food and Drug
Administration
FDA regulates most human and animal food,
including GMO foods. In doing so, FDA makes
sure that foods that are GMOs or have GMO
ingredients meet the same strict safety standards
as all other foods. FDA sets and enforces food
safety standards that those who produce,
process, store, ship, or sell food must follow,
no matter how the foods are created.

U.S. Environmental
Protection Agency
EPA2 is responsible for protecting human health
and the environment, which includes regulating
pesticides. EPA regulates the safety of the
substances that protect GMO plants, referred to
as plant-incorporated protectants (PIPs)3 that are
in some GMO plants to make them resistant to
insects and disease. EPA also monitors all other
types of pesticides that are used on crops,
including on GMO and non-GMO crops.

U.S. Department of
Agriculture
The USDA Animal and Plant Health Inspection
Service (APHIS)4 protects agriculture in the
United States against pests and disease. APHIS
sets regulations to make sure GMO plants
are not harmful to other plants, and USDA’s
Biotechnology Regulatory Services5 implements
these regulations.

Ensuring GMOs are safe
Many federal agencies play an important role in
ensuring the safety of GMOs. As described in the
Coordinated Framework for the Regulation of
Biotechnology,6 FDA works closely with EPA and
USDA to ensure the safety of GMO foods and
plants. Collaboration and coordination among these
agencies help make sure food developers
understand the importance of a safe food supply
and the rules they need to follow when creating
new plants through genetic engineering.
FDA’s voluntary Plant Biotechnology Consultation
Program7 evaluates the safety of food from new
GMOs before they enter the market. This program
allows developers to work with FDA on a
product-by-product basis.

GMO

As
SAFE
AS

non-GMO

How the Plant
Biotechnology
Consultation Program
works
The Plant Biotechnology Consultation Program
is a voluntary program with four key steps:
• GMO plant developer meets with FDA about
a potential new product for use in human and
animal food.
• GMO developer submits food safety
assessment data and information to FDA.

you are eating) is a bioengineered food.
Bioengineered food is the term that Congress used
to describe certain types of GMOs when they
passed the National Bioengineered Food Disclosure
Standard.9 The Standard establishes requirements
for labeling foods that humans eat that are or may
be bioengineered and defines bioengineered
foods10 as those that contain detectable genetic
material that has been modified through certain lab
techniques and cannot be created through
conventional breeding or found in nature. The
Standard requires that by 2022, food makers,
importers, and certain retailers label foods that are
bioengineered or have bioengineered ingredients.
At that time, foods sold in the United States that
meet the definition of bioengineered food must
have information on their packaging using one of
the approved methods,11 including text on the
package that says “bioengineered food,” the
bioengineered food symbol, or directions for using
your phone to find the disclosure. For more
information visit www.ams.usda.gov/be.

• FDA evaluates the data and information and
resolves any issues with the developer.
• Consultation is complete once FDA has no
more questions about the safety of the human
and animal food made from the new GMO
plant variety. Completed consultations are
all made public.8

cRACKERS
How to tell if you are
eating GMOs
Starting in January 2022, certain types of GMOs
will require a disclosure that lets you know the
food you are eating (or ingredients in the food

Get more information about GMOs at
www.fda.gov/feedyourmind.

cereal

Sources:
https://www.usda.gov/topics/biotechnology/how-federal-government-regulates-biotech-plants
https://www.epa.gov
3
https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/overview-plant-incorporated-protectants
4
https://www.aphis.usda.gov/aphis/home
5
https://www.aphis.usda.gov/aphis/ourfocus/biotechnology
6
https://www.usda.gov/topics/biotechnology/how-federal-government-regulates-biotech-plants
7
https://www.fda.gov/food/food-new-plant-varieties/how-fda-regulates-food-genetically-engineered-plants
8
https://www.fda.gov/food/submissions-bioengineered-new-plant-varieties/final-biotechnology-consultations
9
https://www.ams.usda.gov/rules-regulations/be
10
https://www.ams.usda.gov/rules-regulations/be/bioengineered-foods-list
11
https://www.ams.usda.gov/rules-regulations/be/consumers
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