Fordham International Law Journal
Volume 40, Issue 2 Article 7
”So Close, Yet So Far”: The United States
Follows the Lead of the European Union in
Mandating GMO Labeling. But Did It Go Far
Enough?
Courtney Begley
∗
∗
Copyright
c
by the authors. Fordham International Law Journal is produced by The Berkeley
Electronic Press (bepress). http://ir.lawnet.fordham.edu/ilj
625
NOTE
“SO CLOSE, YET SO FAR”: THE UNITED STATES
FOLLOWS THE LEAD OF THE EUROPEAN UNION
IN MANDATING GMO LABELING. BUT DID IT GO
FAR ENOUGH?
Courtney Begley
*
INTRODUCTION ............................................................................. 627
I. THE US AND EU GMO REGULATORY SYSTEMS ................. 635
A. US Regulation of Genetically Modified Organisms ........... 635
1. The Roles, Benefits, and Concerns of GMOs ............... 635
2. United States: The Food and Drug Administration
and Other Agencies ..................................................... 639
3. The 1992 FDA Statement of Policy .............................. 643
4. The Labeling of GMO Products in the United States ... 645
5. The FDA’s Decision Not to Define “Natural” .............. 647
6. The FDA’s Position On Labels Indicating A
Product’s Non-GMO Status ........................................ 650
7. The 1992 FDA Statement of Policy Upheld by the
Courts .......................................................................... 651
B. EU Regulation of GMOs: Product, Labeling, and
Marketing .......................................................................... 655
1. The Precautionary Principle & EU Environmental
Policy .......................................................................... 656
*
J.D. Candidate, 2017, Fordham University School of Law; B.A., 2014, Wagner College.
I would like to thank Professor Roger Goebel for advising me to broaden my study of the
European Union and the Fordham International Law Journal Staff for their excellent
guidance. Most importantly, I would also like to thank my family for their constant support
and encouragement.
626 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
2. The Fundamentals Of The Precautionary Principle ...... 659
3. The Precautionary Principle As Explained By The
Commission ................................................................ 661
4. The Precautionary Principle & Monsanto ..................... 662
5. The Precautionary Principle & Commission v.
Denmark ...................................................................... 665
6. The 1990 Deliberate Release Directive ......................... 667
7. The 2001 Deliberate Release Directive ......................... 677
8. The Genetically Modified Food and Feed
Regulation ................................................................... 680
9. The Labeling of GMOs in the European Union
Under the Traceability and Labeling Regulation ....... 684
10. Comparison of GMO Regulation Between the
United States and the European Union ....................... 685
II. THE PRESSURE FOR MANDATORY GMO LABELING
MEASURES IN THE UNITED STATES AND THE
EUROPEAN UNION .............................................................. 686
A. The Current US Debate Over Mandatory GMO
Labeling ............................................................................. 687
1. The Consumer Right to Know Policy ........................... 688
2. The Consumer Right to Know Policy & The Courts .... 690
3. Connecticut’s GMO Labeling Law ............................... 691
4. Maine’s GMO Labeling Law ........................................ 693
5. Connecticut and Maine’s Trigger Clauses .................... 694
6. Vermont’s Labeling Law .............................................. 695
7. Backlash to State Labeling Laws .................................. 698
8. H.R. 1599 & The Federal Reaction to State GMO
Labeling Laws ............................................................. 700
9. S. 764 and the Nationalization of GMO Labeling
Requirements in the United States .............................. 703
10. Reaction to S.764 ........................................................ 708
B. EU Opposition to GMOs .................................................... 713
1. Labeling Requirements in the European Union
Before the 1998 De Facto Moratorium on GMOs
and the 1997 EU Crisis ............................................... 715
2. A Temporary Solution to the 1997 European Union
Crisis ........................................................................... 718
2017] GMO LABELING IN THE US AND EU 627
3. GMO Labeling Reform Through The 2001
Deliberate Release Directive and the Traceability
and Labeling Regulation ............................................. 720
4. Member States Cultivation Directive ............................ 725
III: ADVANCING GMO TRANSPARENCY UNDER THE
CONSUMER RIGHT TO KNOW POLICY .......................... 728
A. How the United States Avoided a Crisis Similar to the
1997 EU Crisis .................................................................. 728
1. The United States Avoided a Crisis, But Missed the
Goal ............................................................................. 731
B. The Deficiencies of S. 764 .................................................. 732
1. S. 764 Does Not Provide the GMO Transparency
Desired Under the Consumer Right to Know
Policy .......................................................................... 732
2. S. 764’s Burden on Consumers ..................................... 733
3. Problems with Basing GMO Labeling Requirements
on the Final Product and a Threshold ......................... 734
4. S. 764 Fails to Achieve the Goals of the Consumer
Right to Know Policy .................................................. 738
C. Furthering Progress in GMO Transparency ........................ 739
1. The Solution to the GMO Labeling Debate in the
United States ............................................................... 739
2. Tailoring the Solution to US GMO Policy .................... 743
CONCLUSION .................................................................................. 745
INTRODUCTION
The footage aftermath of the 7.0 magnitude earthquake that
devastated Haiti on January 12, 2010 touched the hearts of millions as
they saw buildings flattened to the ground, leaving victims without
homes and suffering without basic necessities.
1
The earthquake
1. See Olivier Laurent, Haiti Earthquake: Five Years After, TIME (Jan. 12, 2015),
http://time.com/3662225/haiti-earthquake-five-year-after/ (describing the 2010 earthquake in
Haiti); Haiti Earthquake Fast Facts, CNN (Dec. 13, 2015, 4:01 PM), http://www.
cnn.com/2013/12/12/world/haiti-earthquake-fast-facts/ (discussing the devastation of the 2010
earthquake).
628 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
resulted in over 200,000 deaths, 300,000 injuries, and 1.5 million
people being initially displaced from their homes.
2
In the wake of the
earthquake, relief came from governments and private citizens alike,
with US$13.34 billion allocated by international agencies and US$4
billion from the US Government.
3
As part of this relief effort, the
agricultural biotechnology corporation Monsanto donated 60,000 seed
sacks, equivalent to 475 tons, of hybrid corn seeds and vegetable
seeds.
4
Despite the dire situation in Haiti at the time, many Haitian
farmers so vehemently opposed the donation that they vowed to burn
the donated seeds.
5
In fact, the farmers considered the donation to be
so catastrophic that they called it “a new earthquake” and
characterized it as a strong attack on small agriculture, biodiversity,
Creole seeds, farmers, and what was left of the environment in Haiti.
6
The reason for this seemingly odd response? GMOs.
7
Prior to 1994, no food sold in US stores contained genetically
modified organisms (“GMOs”), which are defined as “organisms (i.e.
plants, animals or microorganisms) in which the genetic material
(“DNA”) has been altered in a way that does not occur naturally by
mating and/or natural recombination.”
8
In 2015, over seventy percent
2. See Haiti Earthquake Fast Facts, supra note 1 (giving statistics on the earthquake in
Haiti in 2010); Richard Pallardy, Haiti Earthquake of 2010, E
NCYCLOPEDIA BRITANNICA,
http://www.britannica.com/event/Haiti-earthquake-of-2010 (giving information about the 2010
earthquake).
3. See Haiti Earthquake Fast Facts, supra note 1 (providing information on the amount
of relief contributed to the country of Haiti after the earthquake); Haiti Earthquake of 2010,
supra note 2 (discussing relief efforts).
4. See Beverly Bell, Haitian Farmers Commit to Burning Monsanto Hybrid Seeds,
H
UFFINGTON POST (Mar. 17, 2010, 12:44 PM), http://www.huffingtonpost.com/beverly-
bell/haitian-farmers-commit-to_b_578807.html (discussing the Monsanto donation); Michelle
Greenhalgh, Haitian Farmers Reject Monsanto Donation, F
OOD SAFETY NEWS (June 7, 2010),
http://www.foodsafetynews.com/2010/06/haitian-farmers-burn-monsanto-hybrid-seeds/
(explaining Monsanto’s donation of 60,000 seed sacks).
5. Bell, supra note 4 (highlighting the vow of the Haitian farmers to burn the Monsanto
seeds); Greenhalgh, supra note 4 (detailing this pledge).
6. Greenhalgh, supra note 4 (stating why the Haitian farmers so strongly opposed the
donation); Bell, supra note 4 (describing the reasoning behind the farmers’ dissent).
7. See Bell, supra note 4 (discussing the anti-GMO sentiments of the Haitian farmers);
Greenhalgh, supra note 4 (explaining the views of the farmers with respect to GMOs and the
Monsanto donation).
8. Frequently asked questions on genetically modified foods, WHO
http://www.who.int/foodsafety/areas_work/food-technology/faq-genetically-modified-food/en/
(defining genetically modified organisms (GMOs)); Elizabeth Weise, Genetically engineered
2017] GMO LABELING IN THE US AND EU 629
of items sold in US food stores contained GMOs.
9
Yet, until July
2016, the United States resisted joining more than sixty nations that
require GMO labeling and instead regulated GMOs using a voluntary
labeling system, since the Food and Drug Administration (“FDA”)
does not distinguish foods containing GMOs from those that do not.
10
While the FDA has not required labeling because of this policy, at
least ninety-two percent of US citizens desire GMOs to be labeled.
11
Furthermore, despite the fact that more than sixty percent of US
citizens believe that “natural” signifies that a food product contains no
GMOs, the FDA has never issued a formal definition of the word
“natural,” and therefore has allowed companies to advertise their
products that contain GMOs or were made using genetic engineering
foods Q & A, USA TODAY (Dec. 30, 2015), http://www.usatoday.com/story/news/nation/
2012/10/28/gmo-questions/1658225/ (identifying 1994 as the first year a GMO product was
brought to the US market); GMO Timeline – A History of Genetically Modified Foods, GMO
AWARENESS (Dec. 30, 2015), http://gmo-awareness.com/all-about-gmos/gmo-timeline-a-
history-of-genetically-modified-foods/ (listing important dates in the development of GMOs,
including 1994 as the first year a GMO product was on the US market).
9. See Travis Nunziato, “You Say Tomato, I Say Solanum Lycopersicum Containing
Beta-ionone and Phenylacetaldehyde”: An Analysis of Connecticut’s GMO Labeling
Legislation, 69
FOOD & DRUG L.J. 471, 472 (2014) (assessing the percentage of products sold
in the United States that contain GMOs to be seventy percent); see also Michael Potter, Give
Americans what they want and deserve: Label GMO Foods, M
ICH. LIVE (Dec. 30, 2015),
http://www.mlive.com/opinion/index.ssf/2015/09/give_americans_what_they_want.html
(explaining that seventy percent of food on the shelves of grocery stores contain GMOs).
10. See Christina Sarich, The 64 Countries That Require GMO Labeling – U.S. Buckles
Under Biotech Pressure,
NAT. SOC’Y (Oct. 13, 2014), http://naturalsociety.com/64-countries-
require-gmo-labeling-not-united-states/ (stating that during 2014, the United States was not
one of the sixty-four countries that require GMO labeling); Carey Gillam, House Passes Anti-
GMO Labeling Law, R
EUTERS (July 23, 2015, 4:52 PM), http://www.reuters.com/article/us-
usa-gmo-labeling-idUSKCN0PX17920150723 (stating that sixty-four countries required GMO
labeling in 2015).
11. See Julie M. Muller, Naturally Misleading: FDA’s Unwillingness To Define
“Natural” and the Quest for GMO Transparency Through State Mandatory Labeling
Initiatives, 48
SUFFOLK U. L. REV. 511, 523 (2015) (stating that despite its stated intention to
formally define “natural,” the FDA has never issued a formal definition for the term); US Polls
on GE Food Labeling, C
TR. FOOD SAFETY, http://www.centerforfoodsafety.org/issues/976/ge-
food-labeling/us-polls-on-ge-food-labeling (citing numerous reports that report over ninety-
two percent of US citizens want the federal government to require GMO labeling); Gary
Langer, Poll: Skepticism of Genetically Modified Foods, ABC
NEWS (June 19, 2015),
http://abcnews.go.com/Technology/story?id=97567&page=1 (describing a poll in which
ninety-three percent of US citizens believe that the federal government should require labels
on food saying whether it’s been genetically modified or “bio-engineered”).
630 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
(“GE”) as “natural.”
12
Since the FDA has not changed its policy on
GMOs since 1992, it continues to maintain a bare minimum standard
of review for foods containing GMOs.
13
The FDA relies solely on
voluntary information provided by food manufacturers to ensure
safety and compliance with its standards.
14
This regulatory framework departs both from US public opinion
and global standards.
15
Perhaps one of the most comprehensive GMO
regulatory systems is that of the European Union, which is rooted in a
fundamental policy known as the precautionary principle.
16
In sharp
contrast with the United States, which assumes that GMOs are not
materially different from traditional foods and are safe for human
consumption, the European Union has designed its entire GMO
regulatory system on the precautionary principle and assumes that
genetically modified foods are not safe until proven otherwise by
12. See Andrea Rock, Where GMOs hide in your food, CONSUMER REP. (Oct. 2014)
http://www.consumerreports.org/cro/2014/10/where-gmos-hide-in-your-food/index.htm
(describing a Consumer Reports National Survey in which over sixty percent of people said
they believed “natural” means “no GMOs”); Muller, supra note 11 (citing a survey in which
over sixty percent of people said that “natural” means that a product contained no GMOs).
13. See infra notes 85-89 and accompanying text.
14. See Food From Genetically Engineered Plants, FDA,
http://www.fda.gov/Food/FoodScienceResearch/GEPlants/ (last updated Nov. 19, 2015)
(detailing the FDA policy on food from genetically engineered plants and the agency’s
biotechnology policy); U.S. Regulation Of Genetically Modified Crops, F
ED’N AM.
SCIENTISTS, http://fas.org/biosecurity/education/dualuse-agriculture/2.-agricultural-biotechn
ology/us-regulation-of-genetically-engineered-crops.html (last visited Jan. 7, 2016)
(explaining how the FDA regulates GMOs and describing the agency’s voluntary consultation
process with manufacturers).
15. See GMO foods: What you need to know, C
ONSUMER REP. (Feb. 26, 2015, 3:20 PM),
http://www.consumerreports.org/cro/magazine/2015/02/gmo-foods-what-you-need-to-
know/index.htm (discussing that GMO labeling is mandatory in more than sixty countries,
which did not include the United States during 2015); Tom McKay, 64 Countries That Have
GMO Labeling Laws, G
ENETIC LITERACY PROJECT (May 14, 2014), https://www.genetic
literacyproject.org/2014/05/14/64-countries-that-have-gmo-labeling-laws/ (distinguishing the
United States from the sixty-four countries that mandated GMO labeling through 2014).
16. See Harrison Joss, The Rise Of Frankenbeer: A Holistic Analysis On International
Labeling And Beverage Laws Through The Lens Of This Ongoing Controversy Of Genetically
Modified Organisms, 21 ILSA
J. INT’L & COMP. L. 131, 147 (2014) (commenting on how the
precautionary principle in the European Union has created the “strictest and broadest
regulations”); Mystery Bridgers, Genetically Modified Organisms And The Precautionary
Principle: How The GMO Dispute Before The World Trade Organization Could Decide The
Fate Of International GMO Regulation, 22 T
EMP. ENV’T L. & TECH. J. 171, 184 (2004)
(explaining how the European Union used the precautionary principle to design its GMO
regulations).
2017] GMO LABELING IN THE US AND EU 631
reliable scientific research.
17
In accordance with the precautionary
principle, the European Union requires companies to indicate if their
products contain any amount of GMOs past a threshold level.
18
This
requirement allows consumers to choose whether or not to consume
food containing GMOs.
19
Unlike the US structure, the EU regulatory
system operates in a way that reflects public opinion, which is quite
distrustful of genetic engineering and is strongly anti-GMO.
20
Since
the European Union presumes foods containing GMOs to be harmful
unless proven otherwise under the precautionary principle, companies
seeking approval of genetically modified products are required to
submit detailed application materials and undergo a rigorous approval
process based on independent assessments.
21
While the United States has regulated GMOs from a position
that greatly contrasts with that of the European Union for over two
17. See Emily Marden, Risk And Regulation: U.S. Regulatory Policy On Genetically
Modified Food And Agriculture, 44 B.C.
L. REV. 733, 735 (2003) (explaining how the United
States has taken an approach that stands in contrast with the precautionary principle, upon
which the European Union has based its GMO regulatory system); Bridgers, supra note 16, at
184 (stating how the European Union designed its GMO regulatory system using the
precautionary principle).
18. See infra Section I.B and accompanying text (providing an overview for the EU
GMO regulatory system and its foundation in the precautionary principle).
19. See Katherine Wilinska, Aquadvantage Is Not Real Advantage: European
Biotechnology Regulations and the United States’ September 2010 FDA Review of Genetically
Modified Salmon, 21 M
INN. J. INT’L L. 145, 156 (2012) (describing how the precautionary
principle has influenced the EU GMO regulatory system and how the European Union errs on
the side of caution even without any demonstrable risk); Stephanie Amaru, A Natural
Compromise: A Moderate Solution to the GMO and “Natural” Labeling Disputes, 69 F
OOD &
DRUG L.J. 575, 600 (2014) (explaining how, as opposed to the US system under the FDA’s
policy, the European Union has determined a threshold level for GMOs and labeling
requirements according to that level).
20. See Nathan W. Eckley, Reaping The Benefits Of Agricultural Biotechnology Through
Uniform Regulation, 35 J.
MARSHALL L. REV. 433, 442 (2002) (explaining that the motivation
behind the strict approach of the European Union is public distrust of GMOs); Wilinska, supra
note 19, at 155-56 (explaining how European consumers are deeply skeptical about the small
environmental impact of GM foods and do not trust the food safety regulations of the
European Union).
21. See Javier Guillem Carrau, Lack Of Sherpas For a GMO Escape Route In The EU,
10 G
ERMAN L.J. 1169, 1180 (2009) (“[The European Union] regulates a ‘case by case’
authorization process, applying the precautionary principle, in order to make decisions on the
basis of risk assessment, scientific criteria, the introduction of emergency and surveillance
programmes, and so on.”); Wilinska, supra note 19, at 157 (explaining how under the
precautionary principle, the European Union assumes that new technology is not safe until
proven otherwise by extensive scientific research conducted by a separate designated agency).
632 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
decades, this stark polarity has suddenly lessened, as the United States
reversed its long-held policy on GMO labeling by enacting federal
GMO labeling requirements under S. 764 in 2016.
22
The complete
reversal in US policy occurred as a result of the state movement that
pushed for GMO labeling requirements and brought about much
dispute among those in federal government, the food industry, and
state government.
23
From 2014 to 2016, consumer demand for GMO
labeling reached an all time high in the United States, as individual
states such as Vermont and Connecticut enacted their own legislation
mandating the labeling of GMOs.
24
While the FDA has refused to
require such labeling since 1992 in contrast with growing public
opposition, these states listened to the concerns of their citizens and
acted in defiance of the FDA’s policy.
25
It is this consumer opposition
and state action that prompted the US Congress to quickly implement
S. 764, which mandates GMO labeling of bioengineered foods, as a
solution to the GMO labeling crisis.
26
S. 764 signaled both triumph
and defeat on both sides of the GMO debate, as those advocating state
GMO labeling measures witnessed the revolutionary laws of
Vermont, Connecticut, and Maine become federally preempted, while
others who vehemently opposed GMO labeling watched it become a
22. See infra Section II.A (highlighting this sudden shift to mandatory GMO labeling
under S. 764).
23. See infra Section II.A. (explaining the impact of the state movement toward
mandatory GMO labeling on the US federal government and the conflict associated with such
state measures).
24. See Dana Ford & Lorenzo Ferrigno, Vermont Governor Signs GMO Food Labeling
Into Law, CNN (May 8, 2014, 9:17 PM), http://www.cnn.com/2014/05/08/health/vermont-
gmo-labeling/ (announcing that Vermont passed the first state GMO labeling law without a
requirement that other states enact similar laws in order for it to go into effect); Stephanie
Strom, Connecticut Approves Labeling Genetically Modified Foods, NY
TIMES (June 3, 2013),
http://www.nytimes.com/2013/06/04/business/connecticut-approves-qualified-genetic-
labeling.html?r=0 (stating that Connecticut became the first state to pass a GMO labeling law
and explaining the conditions that had to be met for the law to go into effect).
25. See Statement of Policy: Foods Derived From New Plant Varieties, 57 Fed. Reg.
22984-01 (May 29, 1992) [hereinafter 1992 FDA Statement of Policy] (not requiring GMO
labeling); Clare Leschin-Hoar, Vermont Takes On Genetically Modified Foods With New
Labeling Law, G
UARDIAN (May 8, 2014, 10:38 PM), http://www.theguardian.com/sustainable-
business/vermont-gmo-labeling-law-genetically-modified-foods-lawsuits (describing some of
the arguments surrounding the states’ actions to require GMO labeling when the FDA does
not).
26. See infra Section II.A.
2017] GMO LABELING IN THE US AND EU 633
federal requirement.
27
While S. 764 has been met with both great
praise and disdain, it is undeniable that the federal measure will
significantly change the way in which GMOs are regulated at the
federal level, which used to be governed solely by the 1992 FDA
Statement of Policy and the agency’s strict opposition to GMO
labeling requirements.
28
Therefore, as shown by this brief overview, the regulatory
systems of the European Union and United States that govern GMOs
radically differ due to the contrasting principles upon which they are
based.
29
The US regulatory system is based on the substantial
equivalence doctrine, which assumes that GMOs are substantially
equivalent to their traditional counterparts and therefore present no
new risks beyond those of conventional organisms.
30
In contrast to the
United States, the European Union formed an entirely new regulatory
system based on the precautionary principle, which allows
governments to take preventative action to avoid potentially serious
environmental dangers even if the causal connection has not been
scientifically confirmed.
31
Accordingly, the two regulatory systems
are unlikely to ever completely mirror one another.
32
However, the
27. See infra Section II.A.10.
28. See infra Sections I.A, II.A.10.
29. See generally Rebecca M. Bratspies, Is Anyone Regulating? The Curious State Of
GMO Governance In The United States, 37 V
T. L. REV. 923, 929-39 (2013) (explaining how
the substantial equivalence doctrine, which asserts that genetically engineered products are
equivalent to their unmodified counterparts, formed the basis of the US GMO regulatory
system); Wilinksa, supra note 19, at 156-57 (detailing how the precautionary principle, which
serves as the foundation of the EU GMO regulatory system, presumes genetically engineered
products to be unsafe until proven otherwise).
30. See Bratspies, supra note 29, at 929 (defining the substantial equivalence doctrine);
Nunziato, supra note 9, at 479 (stating that the FDA treats GMOs as substantially equivalent to
their non-GMO counterparts).
31. See Wilinska, supra note 19, at 156 (describing how the European Union, even
without evidence of risk, errs on the side of caution); Bridgers, supra note 16, at 184
(articulating how a lack of scientific certainty concerning the cause of risks should not be an
obstacle to preventative action being taken).
32. See The EU-US Dispute over GMOs: Risk Perceptions and the Quest for Regulatory
Dominance, EU
CTR. N.C. (May 2007), http://europe.unc.edu/wp-content/uploads/2013/
08/Brief0705-GMOs.pdf (highlighting the many differences between the two regulatory
systems and commenting on how the transatlantic differences have not been settled); Jessica
Lau, Same Science, Different Policies: Regulating Genetically Modified Foods in the U.S. and
Europe, S
CI. IN NEWS (Aug. 2015), http://sitn.hms.harvard.edu/flash/2015/same-science-
different-policies/ (comparing the two regulatory systems and explaining how the United
634 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
United States has followed the example of the European Union and
implemented a mandatory labeling regime under S. 764 in order to
avoid a patchwork system of GMO labeling requirements and calm
public unrest.
33
While mandatory GMO labeling is now a reality in
the United States, there still exists a preferable solution that better
aligns with public opinion and will result in true GMO transparency
based on the Consumer Right to Know Policy.
34
Part I of this Note will discuss the US and EU regulatory
systems and will introduce the debate over GMO labeling in the
United States. Part II will discuss the state GMO labeling laws that
prompted Congress to pass S. 764 and will include a discussion of the
Consumer Right to Know Policy. Part II will also detail how the
demand for mandatory GMO labeling led to a crisis in the European
Union in 1997, when several Member States banned an approved
GMO product because it was not required to be labeled as a GMO.
Finally, this Part will discuss how the opposition from the Member
States was only resolved through the implementation of stricter
labeling requirements under the Traceability and Labeling
Regulation. Part III will offer a solution to the current US debate over
mandatory GMO labeling. In Part III, this Note will argue that while
the United States successfully followed the example of the European
Union by implementing a mandatory GMO labeling regime, it failed
to achieve GMO transparency. Part III will show how the United
States Congress should replace S. 764 with a system based on the
Consumer Right to Know Policy that requires labeling based on the
process of genetic engineering. By implementing such a system at the
federal level, the United States will answer the public demand for the
ability to make informed decisions and adhere to the 1992 FDA
Statement of Policy.
States focuses on the end product while the European Union emphasizes the processes used to
develop the end product).
33. See infra Part II.
34. See infra Part III.
2017] GMO LABELING IN THE US AND EU 635
I. THE US AND EU GMO REGULATORY SYSTEMS
This Part gives an overview of both the US and EU GMO
regulatory systems, including their foundational principles and how
they were developed. Section I.A explains the Coordinated
Framework and the 1992 FDA Statement of Policy, which led to the
decision not to mandate GMO labeling in the United States. Section
I.B details the many changes sustained by the EU GMO regulatory
system and further discusses the series of Directives and Regulations
that have formed the European Union’s current regulatory system.
Through these discussions, Section I.A shows how the United States
has based its GMO regulatory system on the substantial equivalence
doctrine, while Section I.B stresses the importance of the
precautionary principle as the foundation of the EU GMO regulatory
system. Finally, Section I.B also includes a comparison of the EU and
US GMO regulatory systems.
A. US Regulation of Genetically Modified Organisms
This Section details how the United States regulates GMOs
through existing laws within three federal agencies under a system
known as the Coordinated Framework. Section I.A.1 examines the
regulation of GMOs under the Coordinated Framework, while Section
I.A.2 explains how the FDA regulates GMOs through existing law
under the Federal Food and Drug Cosmetic Act (“FDCA.”) Section
I.A.3 provides an analysis of the 1992 FDA Statement of Policy
concerning GMOs and the substantial equivalence doctrine. Section
I.A.4 explains the lack of mandatory labeling for GMOs, while
Sections I.A.5 and I.A.6 provide the FDA position on defining
“natural” and labeling products that do not contain GMOs. Finally,
Section I.A.7 shows how the 1992 FDA Statement of Policy has been
upheld by the courts.
1. The Roles, Benefits, and Concerns of GMOs
Genetic modification is a process of biotechnology whereby
genetic material of an organism is manipulated to deliberately modify
636 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
the organism’s characteristics to create new variations of life.
35
This
technology has been greatly beneficial in agriculture and
pharmaceuticals.
36
For example, the first human insulin was created
using methods of genetic modification.
37
Because of GMOs, farmers
are able to plant herbicide-resistant plants and plants that are more
resistant to diseases, droughts, and pesticides.
38
This has also led to
increased crop productivity, longer shelf life, lower use of chemical
pesticides, and lower average levels of fungal toxins on produce.
39
35. See Nunziato, supra note 9, at 474 (giving a definition for genetic modification);
Definition of biotechnology, M
ERRIAM-WEBSTER, http://www.merriam-webster.com/
dictionary/biotechnology (last visited Jan. 6, 2016) (“Definition of biotechnology: the
manipulation (as through genetic engineering) of living organisms or their components to
produce useful usually commercial products (as pest resistant crops, new bacterial strains, or
novel pharmaceuticals)”). To create these new variations of life, scientists first extract DNA
from the designed organism and isolate a particular gene of interest. After a particular section
of DNA has been extracted and isolated, scientists can manipulate the gene to work in the new
organism and finally combine it with another segment of DNA from another cell to create a
“new” organism. As a result, the organism is able to express the trait encoded by that gene,
usually to the organism’s benefit. See Amy Glasscock, How America Can Move Closer
Toward Mandated Labeling for Genetically Modified Foods and Remain 1
st
Amendment
Compliant, 14 H
OUS. J. HEALTH L. & POL’Y 223, 226 (2014) (detailing the process involved
in genetic engineering and how original organisms are modified to result in a new
transformation); Charlotte Davis, A Right to Know about GMOs: What American Meat
Institute v. USDA Means for Vermont’s Food Labeling Law, 16 N.C.
J.L. & TECH. ON.
E
DITION 32, 36 (2015) (describing the results of this process); Nunziato, supra note 9, at 474-
75 (describing how a GMO is developed and explaining that the new organism can express the
new trait that is encoded by the gene).
36. See Benefits of Genetic Engineering, X
AMPLIFIED, http://www.chemistrylearning.
com/benefits-of-genetic-engineering/ (last visited Jan. 7, 2016) (describing many of the
benefits of genetic engineering in the field of science); Nunziato, supra note 9, at 475
(explaining how genetic modification has brought about many benefits in the areas of
agriculture and pharmaceuticals).
37. See Nunziato, supra note 9, at 475 (describing how the first human insulin was
created using genetic modification methods); Benefits of Genetic Engineering, supra note 36
(describing how genetic engineering was used to develop human insulin).
38. See George A. Kimbrell & Aurora L. Paulsen, The Constitutionality of State-
Mandated Labeling For Genetically Engineered Foods: A Definitive Defense, 39 V
T. L. REV.
341, 355 (2014) (stating that genetically engineered crops are agricultural biotechnology’s
major research and development focus); Benefits of Genetic Engineering, supra note 36
(giving an overview of many of the agricultural benefits of genetic engineering).
39. See Valery Federici, Genetically Modified Food and Informed Consumer Choice:
Comparing U.S. and E.U. Labeling Law, 35 B
ROOKLYN J. INT’L L. 515, 524 (2010) (putting
forth many of the positive impacts of GMOs); Kyndra A. Lundquist, Note, Unapproved
Genetically Modified Corn: It’s What’s for Dinner, 100 I
OWA L. REV. 825, 830 (2015)
(detailing some of the agricultural advances made with genetic engineering); Nunziato, supra
note 9, at 475-76 (explaining some of the benefits of GMOs).
2017] GMO LABELING IN THE US AND EU 637
The popularity of such biotechnology is not to be underestimated.
40
As of 2014, genetically engineered crops made up ninety-three
percent of US corn acreage, ninety-four percent of US soybean
acreage, and ninety-six percent of US cotton acreage.
41
Worldwide,
the number of acres planted with genetically engineered crops grew
from 167 million acres in 2004 to 448 million acres in 2014.
42
GMO proponents argue that in addition to the benefits
previously described, other positive impacts include lower food
prices, reduction in greenhouse gases, increased production of
biofuels, decrease in soil erosion, and social benefits like reduction in
hunger in developing countries.
43
On the opposite side of the debate,
there are many concerns over the safety of GMOs with respect to
human health and the environment.
44
Part of these concerns stem from
what is unknown about GMOs, specifically how genetically modified
genes interact with other genes and the environment.
45
Health
concerns include increased allergenicity, compromised immune
40. See JUSTICE MING W. CHIN ET AL., FORENSIC DNA EVIDENCE: SCIENCE AND THE
LAW § 13:16, 1 (showing the impressive impact of biotechnology); Biotech industry –
Statistics & Facts, S
TATISTA, http://www.statista.com/topics/1634/biotechnology-industry/
(last visited Jan. 7, 2017) (stating that the United States generates US$90 billion in biotech
revenue and that globally, US$160 billion were spent on biopharmaceuticals in 2011).
41. See C
HIN ET AL., supra note 40, at 1 (giving statistics for genetically engineered
crops); Adoption of Genetically Engineered Crops in the U.S.: Recent Trends, US
DEP’T
AGRIC. ECON. RES. SERV., http://www.ers.usda.gov/data-products/adoption-of-genetically-
engineered-crops-in-the-us/recent-trends-in-ge-adoption.aspx (showing statistics concerning
GE soy and corn crops).
42. See
CHIN ET AL., supra note 40, at 1 (describing how the number of acres grown
worldwide has multiplied); Global Status of Commercialized Biotech/GM Crops in 2014,
I
NT’L SERV. ACQUISITION AGRI-BIOTECH APPLICATIONS, http://www.isaaa.org/resources/
publications/pocketk/16/ (showing this jump in GE crops).
43. See
CHIN ET AL., supra note 40, at 1 (setting forth these benefits by GMO
proponents); Maria Gabriela Balboa, Legal Framework To Secure The Benefits While
Controlling The Risks Of Genetically Modified Foods: A Comparison Of The Cartagena
Protocol And Three National Approaches, 31 T
EMP. J. SCI. TECH. & ENV’T L. 255, 258-59
(2012) (discussing these and other benefits claimed by GMO advocates).
44. See Balboa, supra note 43, at 259 (contrasting the listed benefits with the common
fears surrounding GMOs); Nunziato, supra note 9, at 476 (discussing many of the fears
surrounding GMOs).
45. See generally Balboa, supra note 43, at 259-61 (explaining many of the concerns
surrounding the unknown effects of GMOs); Nunziato, supra note 9, at 476 (analyzing many
of the arguments against GMOs based on what is not known about them).
638 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
function, antibiotic resistance, and increased toxicity.
46
With respect
to agriculture, the biggest benefits of GMOs are also seen by some as
the biggest negatives of genetic engineering.
47
While genetic
engineering is used for its ability to make crops more herbicide-
resistant, environmentalists are concerned that this may lead to
increased human consumption of dangerous toxins and may
jeopardize seed diversity.
48
While most scientific research supports
the argument that GMOs are safe for human health, many individuals
around the world demand either a ban on the use of GMOs or labeling
laws that require GMO information on food labels.
49
46. See Balboa, supra note 43, at 259 (discussing these concerns); Nunziato, supra note
9, at 476 (analyzing some of the concerns regarding GMOs).
47. See Herbicide Resistant Crops, GMO
COMPASS (Dec. 11, 2006), http://www.gmo-
compass.org/eng/agri_biotechnology/breeding_aims/146.herbicide_resistant_crops.html
(explaining the position of critics who claim that the use of herbicide resistant crops can lead
to an increase in herbicide use and damage biodiversity); Rachel Rettner, New GMO
Controversy: Are The Herbicides Dangerous,
LIVE SCI. (Aug. 19, 2015, 5:08 PM),
http://www.livescience.com/51917-gmo-herbicides-health.html (explaining the argument that
herbicide resistant GM crops have caused an increase in the use of herbicide).
48. See Beth Hoffman, GMO Crops Mean More Herbicide, Not Less, F
ORBES (July 2,
2013, 11:39 AM), http://www.forbes.com/sites/bethhoffman/2013/07/02/gmo-crops-mean-
more-herbicide-not-less/#35c065faa371 (stating that despite the main argument that
genetically engineered crops will allow farmers to use less herbicide and pesticide, USDA and
EPA data shows that the use of genetically engineered crops has actually increased the use of
herbicide in the United States); Herbicide Tolerant Crops, B
EYOND PESTICIDES,
http://www.beyondpesticides.org/programs/genetic-engineering/herbicide-tolerance (citing a
USDA report that found that herbicide use on GE corn rose from 1.5 pounds per planted acre
in 2001 to more than 2.0 pounds in 2010).
49. See Jon Entine, The Debate About GMO Safety Is Over, Thanks To A New Trillion-
Meal Study, F
ORBES (Sept. 17, 2014), http://www.forbes.com/sites/jonentine/2014/09/17/the-
debate-about-gmo-safety-is-over-thanks-to-a-new-trillion-meal-study/#4eb692b7ca93
(explaining how many major studies have found that GMOs are as safe or safer than
conventional or organic foods and that biotechnology does not pose an unusual risk to human
health); Stefaan Blancke, Why People Oppose GMOs Even Though Science Says They Are
Safe, S
CI. AM. (Aug. 18, 2015), http://www.scientificamerican.com/article/why-people-
oppose-gmos-even-though-science-says-they-are-safe/ (analyzing why so many individuals
oppose GMOs and believe that they are harmful to human health and the environment despite
“overwhelming evidence that proves GMOs are safe to eat, and that they bring environmental
benefits by making agriculture more sustainable”); McKay, supra note 15 (explaining that
even though GMO foods are generally considered safe for human consumption, 64 countries
required GMO labeling in 2014).
2017] GMO LABELING IN THE US AND EU 639
2. United States: The Food and Drug Administration and Other
Agencies
In 1986, the White House Office of Science and Technology
(“OST”) began regulating biotechnology by issuing the Coordinated
Framework for Regulation of Biotechnology (“Coordinated
Framework”).
50
Intended to be the comprehensive federal policy that
would assure safety in biotechnology, the Coordinated Framework
was based upon two principal policy views.
51
The first policy element
was that existing law was sufficient to deal with the regulatory needs
of genetically modified products, which signaled the administration’s
refusal to promulgate GMO-specific rules.
52
The second policy factor,
known as the “substantial equivalence doctrine,” maintains that
products containing GMOs present no new risks as opposed to
traditional products that are not genetically modified.
53
Although the
Coordinated Framework was not enacted into law, it would later
become clear that its principles were to be the foundation of the US
GMO regulatory system.
54
The Coordinated Framework was mirrored
by the 1992 FDA Statement of Policy, which brought about the GMO
regulatory process that the United States has used for over twenty
years.
55
50. See Nunziato, supra note 9, at 477 (detailing the Coordinated Framework);
Lundquist, supra note 39, at 831 (explaining the Coordinated Framework).
51. See Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23302
(June 26, 1986); Lundquist, supra note 39, at 831 (quoting the Coordinated Framework and
describing its stated purpose); Nunziato, supra note 9, at 477 (detailing the fundamental
purpose of the Coordinated Framework).
52. See Lundquist, supra note 39, at 831 (acknowledging the idea under the Coordinated
Framework that existing law is sufficient to regulate GMOs); Nunziato, supra note 9, at 477
(stating the stance that no new legislation was required under the Framework to regulate GMO
products).
53. See Lundquist, supra note 39, at 831 (explaining the substantial equivalence
doctrine); Sheryl Lawrence, What Would You Do With a Fluorescent Green Pig? How Novel
Transgenic Products Reveal Flaws in the Foundational Assumptions for the Regulation of
Biotechnology, 34 E
COLOGY L.Q. 201, 219 (2007) (describing this second policy factor).
54. See Lundquist, supra note 39, at 831 (demonstrating how the GMO regulatory
system is guided by the Coordinated Framework); Bratspies, supra note 29, at 929-30 (“ . . .
with virtually no modifications in the intervening decades, this Coordinated Framework
continues to govern regulatory decisions about agricultural biotechnology.”).
55. See Bratspies, supra note 29, at 938 (explaining how the FDA built upon the
substantial equivalence mindset of the Coordinated Framework); Nunziato, supra note 9, at
640 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
While this policy did not implement any new measures
specifically crafted for GMOs, it placed the regulation of foods,
medical devices, drugs, biologics, and pesticides developed through
modern biotechnology within the same existing statutory system that
regulates similar products developed using traditional methods, such
as traditionally bred foods.
56
Traditional breeding usually involves the
hybridization between varieties of the same species and, therefore,
can only introduce traits that are found in close relatives.
57
Thus, corn
that has been produced using genetic modification is treated the same
as corn that has been produced without the use of such methods.
58
Hence, products that are derived from traditional methods, like
traditional crossbreeding, are to be regulated under the same rules and
standards as products derived from genetic engineering methods,
including gene insertion.
59
Under this framework, GMOs are
regulated by the FDA under two sections of the FDCA.
60
The first
component of this framework is the General Safety Clause of FDCA
Section 402(a)(1), which considers food that contains any poisonous
or dangerous substance that makes it injurious to health as adulterated
and subject to seizure.
61
The second component is the Food Additives
Amendment of FDCA Section 409, which provides the procedures for
approval of food additives and divides substances that are added to
food into two categories: food additives and substances generally
478 (describing how the Coordinated Framework is still the same basic organizing principle
for GMO regulation in the United States).
56. See Jeffrey K. Francer, Frankenstein Foods or Flavor Savers?: Regulating
Agricultural Biotechnology in the United States and European Union, 7 V
A. J. SOC. POL’Y &
L. 257, 265-66 (2000) (detailing what is regulated within the existing law); Nunziato, supra
note 9, at 477-78 (explaining that no new laws would be enacted to regulate biotechnology).
57. See 1992 FDA Statement of Policy, supra note 25, at 22986 (discussing traditional
breeding).
58. See generally id.; Nunziato, supra note 9, at 479 (giving the corn example).
59. See Francer, supra note 56, at 265-66 (demonstrating how such products would be
regulated under the same rules). See generally Bratspies, supra note 29, at 929-30 (detailing
the principles of the Coordinated Framework).
60. See Bratspies, supra note 29, at 937-38 (detailing the regulatory power of the FDA
and the FDCA); Francer, supra note 56, at 267-70 (giving an overview of the statutory
framework of the FDA regulatory system).
61. 21 U.S.C. § 341(a)(1) (1994); see Francer, supra note 56, at 268 (quoting section
402(a)(1) of the FDCA and describing the power of the FDA under the General Safety
Clause).
2017] GMO LABELING IN THE US AND EU 641
recognized as safe (“GRAS”).
62
This section allows the FDA to
subject manufacturers to premarket approval unless their food product
is recognized as safe.
63
In order to be deemed safe under the FDCA,
competent scientists must be reasonably certain that a substance is not
harmful under the intended conditions of the use.
64
A food additive
that does not fit this definition is considered “unsafe,” and the food
containing the additive is deemed adulterated.
65
If the substance is
determined to be “safe,” it is not considered a food additive and thus
no prior FDA approval is necessary.
66
The Coordinated Framework resulted in a three-part regulatory
system that delegates genetic engineering regulation to three
government agencies: the FDA, the Environmental Protection Agency
(“EPA”), and the United States Department of Agriculture
(“USDA”).
67
Under the Coordinated Framework, the FDA has
authority to regulate food, feed, veterinary drugs, and food additives
developed by biotechnology as delegated by the FDCA.
68
As a second
part of the Coordinated Framework, the EPA is responsible for
regulating the manufacture and release into the environment of
microbial products of biotechnology and pesticides manufactured
through biotechnology through the Toxic Substances Control Act
62. See Francer, supra note 56, at 267 (discussing section 409 of the FDCA); Bratspies,
supra note 29, at 937 (explaining that substances added to food fall into either of these two
categories).
63. See Bratspies, supra note 29, at 937 (discussing how the FDA can mandate
premarket approval with respect to food additives); Francer, supra note 56, at 269 (describing
the application of premarket approval to food additives depending on their safety status).
64. 21 C.F.R. § 170.30(i) (2016); see Bratspies, supra note 29, at 937 (describing how
the FDA defines “safe” with respect to premarket approval for food additives).
65. 21 U.S.C. §§ 331(a), 342(a)(1), (2)(C) (2015); see Bratspies, supra note 29, at 937
(stating that the FDA will deem a food containing an additive that is unsafe as “adulterated”).
66. See Bratspies, supra note 29, at 937 (explaining that if a substance added to food is
“generally recognized as safe,” it is not deemed to be a food additive and therefore prior FDA
approval is not required); Francer, supra note 56, at 269 (stating that the FDA is allowed to
require food manufacturers to apply for premarket approval of food that has a substance added
to it unless the food is “generally recognized as safe”).
67. See Lundquist, supra note 39, at 831-32 (detailing the three-part system under the
Coordinated Framework and how responsibilities are divided among the agencies); Francer,
supra note 56, at 66 (explaining how the different agencies work within the framework);
Muller, supra note 11, at 519 (describing how the regulation of biotechnology is divided
among the three agencies under the Coordinated Framework).
68. See Nunziato, supra note 9, at 478 (establishing the FDA’s responsibilities); Francer,
supra note 56, at 266 (articulating the FDA regulation of GMOs through the FDCA).
642 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
(“TSCA”) and the Federal Insecticide, Fungicide, and Rodenticide
Act (“FIFRA”).
69
Finally, as the third part of this Framework, the
USDA is charged with regulating the use of genetically modified
plants, animals, and microorganisms in agriculture as part of the
Federal Plant Protection Act.
70
The regulation carried out by these three agencies is firmly
rooted in the Coordinated Framework’s two principles, as well as the
conclusion of the National Research Council (“NRC”) that because
the same physical and biological laws govern genetically modified
and non-modified organisms, genetically modified organisms do not
present a greater risk to human health than unmodified organisms.
71
As a result, the FDA, EPA, and USDA all regulate the genetically
modified items within their jurisdiction through their traditional
procedures.
72
Through this application of the Coordinated Framework
and substantial equivalence doctrine, products subject to FDA
regulation must comply with the same safety standards as their natural
counterparts (i.e., unmodified organisms).
73
For example, as
previously discussed, corn that is produced by using genetic
modification is regulated the same way as corn that has been
produced without the use of genetic modification.
74
While the
69. See Nunziato, supra note 9, at 474 (describing the EPA’s responsibilities under the
Coordinated Framework); Francer, supra note 56, at 266 (citing the TSCA and FIFRA and
describing the EPA’s duties with respect to biotechnology).
70. See Lundquist, supra note 39, at 835 (describing the USDA’s role within the
Coordinated Framework through the Federal Plant Protection Act); Nunziato, supra note 9, at
478 (commenting on the USDA’s responsibilities under the Coordinated Framework).
71. See Francer, supra note 56, at 266 (commenting on how the NRC’s conclusion that
products developed through biotechnology do not entail greater risk “per se” compared to
unmodified products served as the basis for the Coordinated Framework’s policy); see also
Alison Peck, Leveling the Playing Field in GMO Risk Assessment: Importers, Exporters and
the Limits of Science, 28 B.U.
INT’L L.J. 241, 257 (2010) (describing some findings of the
NRC with respect to GMOs).
72. See Francer, supra note 56, at 267 (explaining how the three agencies regulate
GMOs). See generally Lundquist, supra note 39, at 832 (discussing how the agencies operate
when regulating GMOs or GE products).
73. See Nunziato, supra note 9, at 479 (detailing how the FDA treats GMOs the same as
their conventional counterparts). See generally Federici, supra note 39, at 537 (describing how
GMOs are evaluated under the same laws as their conventionally produced counterparts by the
FDA).
74. See generally 1992 FDA Statement of Policy, supra note 25; Nunziato, supra note 9,
at 479 (explaining how unmodified corn and genetically modified corn are treated as
substantially equivalent to one another by the FDA, which generally recognizes both as safe).
2017] GMO LABELING IN THE US AND EU 643
substantial equivalence doctrine has its roots in the 1986 findings of
the NRC, it was further solidified and incorporated into US regulation
through the 1992 FDA Statement of Policy.
75
3. The 1992 FDA Statement of Policy
The 1992 FDA Statement of Policy has had a major impact upon
the regulation of GMOs in the United States.
76
It has steered the
regulatory system in a way that greatly lessened the burden on
manufacturers to get GMO products approved for sale.
77
Instead of
regulating GMOs within the much stricter approach of FDCA Section
409, the FDA announced that it would continue to mainly rely on
Section 402(a)(1)—which only deals with substances that may be
injurious to health—for the safety of whole foods and those derived
from plants genetically modified by new techniques.
78
Furthermore,
the FDA decided that it was the responsibility of the producer of a
new food to evaluate the safety of that food and to ensure that the
safety requirements under Section 402(a)(1) are met.
79
The FDA also
stated that it encouraged producers to informally consult FDA
scientists to ensure that safety concerns are resolved and that the
producers are legally responsible for satisfying Section 402(a)(1) of
75. See generally Nunziato, supra note 9, at 479 (explaining how the FDA treats GMOs
as substantially equivalent to their non-GMO counterparts); Bratspies, supra note 29, at 929
(explaining how substantial equivalence was the central assumption guiding the Coordinated
Framework).
76. See generally supra Section I.A (demonstrating how the 1992 FDA Statement of
Policy has shaped the US GMO regulatory system, specifically with respect to labeling).
77. See generally Rebecca Jesada, Buyer Beware: An Exploration Of Health Risks And
Legal Policies In Favor Of A Labeling Requirement For Genetically Modified Organisms, 14
J.
HEALTH CARE L. & POL’Y APPENDIX S-30, S-38-39 (2011) (explaining the voluntary
consultation process for GMO approval with the FDA); Francer, supra note 56, at 269 (stating
that the FDA allows manufacturers to determine whether genetically modified foods are
GRAS).
78. See 1992 FDA Statement of Policy, supra note 25, at 22990 (announcing that GMOs
would be regulated under section 402(a)(1) of the FDCA); Francer, supra note 56, at 270
(describing how the FDA relies on section 402(a)(1) of the FDCA to regulate genetically
modified foods).
79. See 1992 FDA Statement of Policy, supra note 25, at 22990 (showing that the FDA
would not be relying on its own independent research, but rather on the food producers to
evaluate the safety of the food and to make sure their foods meet the safety standards under
section 402(a)(1)).
644 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
the act.
80
With respect to Section 409, the FDA stated that it would
not require genetically engineered foods to be regulated as food
additives under this section.
81
This, the FDA reasoned, was because
GMOs are presumptively GRAS and therefore not subject to Section
409, including the food additive approval process.
82
The FDA further
noted that it did not anticipate any serious questions about the GRAS
status of transferred genetic material and therefore did not expect such
transferred genetic material to be subject to food additive regulation.
83
It was from this viewpoint that the FDA put forth a policy that
presumes that added genetic material from substances already in the
food supply is GRAS.
84
This FDA policy has greatly affected the process of GMO
regulation, as leading producers such as Monsanto are not required to
submit their GMO products for FDA approval.
85
As these products
are protected by a presumption of safety, GMOs are not subject to
FDA independent research, but are only regulated based upon
information that such companies voluntarily give to the FDA.
86
80. See id. (identifying the agency’s role in the GMO approval process).
81. See id. (explaining the FDA’s reasoning behind its decision to not regulate GMOs
under section 409 and its continued position that such materials are presumed to be GRAS).
82. See id. (describing the FDA’s presumption that GMOs are GRAS and therefore not
subject to regulation as food additives).
83. See id. (asserting the FDA’s position that it does not anticipate that transferred
genetic material would itself be subject to food additive regulation).
84. See Francer, supra note 56, at 270 (summarizing the FDA’s viewpoint concerning
added genetic material from substances that already exist in the food supply); see also 1992
FDA Statement of Policy, supra note 25, at 22990 (“When the substance present in the food is
one that is already at generally comparable or greater levels in currently consumed foods, there
is unlikely to be a safety question sufficient to call into question the presumed GRAS status of
such naturally occurring substances and thus warrant formal premarket review and approval by
FDA.”).
85. See Bratspies, supra note 29, at 938 (assessing how companies such as Monsanto are
allowed to voluntarily consult with the FDA before marketing a new GE food product and how
they are responsible for ensuring that the product is safe but are not required to prove safety to
the FDA); Francer, supra note 56, at 269 (noting that consultation with the FDA regarding an
ingredient’s regulatory status is not legally required).
86. See Bratspies, supra note 29, at 938-39 (detailing how this “developer-driven
consultation” process “imposes no obligation on the developer to share all its data, including
negative or inconclusive results with the agency” and also explaining that the FDA does not
conduct any independent testing of the GMO food products); see also Tiffany B. Wong,
Comment, Playing Politics With Food: Comparing Labeling Regulations Of Genetically
Engineered Foods Across The North Atlantic In The United States And The European Union,
2017] GMO LABELING IN THE US AND EU 645
Furthermore, since genetically engineered traits can be classified as
“novel proteins,” companies are allowed to withhold all information
about the properties of the proteins and are therefore not compelled to
disclose this information to the FDA regardless of their potential harm
to humans or animals.
87
Before such GMO products are approved, the
FDA does not conduct any independent testing.
88
It therefore
approves GMO products by relying solely on the information
voluntarily provided to it by the companies seeking approval.
89
4. The Labeling of GMO Products in the United States
In addition to its dramatic effect on the GMO approval process,
the 1992 FDA Statement of Policy significantly influenced the way
GMO products have been labeled for over twenty years in the United
States.
90
It is important to note that while the following information
concerning GMO labeling has been accurate from 1992 to 2016, it is
no longer the standard for GMO labeling in the United States as S.
764 now mandates GMO labeling for products that are classified as
“bioengineered food.”
91
Even though GMO labeling is now
mandatory under S. 764, the information below provides a crucial
23 SAN JOAQUIN AGRIC. L. REV. 243, 254 (2013-2014) (indicating that the FDA relies on food
companies “to voluntarily conduct a premarket food safety assessment”).
87. See Glasscock, supra note 35, at 236 (specifying how the “novel proteins”
classification of genetically engineered traits permits biotech companies to withhold all
information about the properties of the protein, “even their general nature, including potential
toxicity to humans or other wildlife”); Bratspies, supra note 29, at 938 (detailing how
companies are not obligated to share all their data with the FDA and how the FDA only
reviews the information submitted by companies voluntarily).
88. See Muller, supra note 11, at 520 (discussing this lack of independent testing);
Francer, supra note 56, at 270 (describing the FDA’s guidance framework for manufacturers).
89. See Muller, supra note 11, at 520 (indicating that the FDA does not conduct a safety
assessment on genetically modified foods and shifts the responsibility to the producers who
create the genetically modified crops to voluntarily disclose any studies that have been
conducted on the product). See generally Francer, supra note 56, at 270 (giving an overview of
the FDA’s guidance framework for manufacturers in which the agency suggests, but does not
require, consultation as well as the included flowchart that is meant to help manufacturers to
determine if they should engage in a formal consultation with the FDA).
90. See Francer, supra note 56, at 272 (stating that the 1992 FDA Statement of Policy
declined to mandate labeling of genetically modified foods); Muller, supra note 11, at 518-20
(detailing how the 1992 FDA Statement of Policy has impacted the agency’s stance on GMO
labeling).
91. See infra notes 459-66 and accompanying text (discussing the mandates for products
that are classified as “bioengineered food” under S. 764).
646 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
overview of the FDA policy that governed GMO labeling in the
United States for over twenty years and which gave rise to the state
movement for GMO labeling and the enactment of S. 764 as a
compromise to calm public unrest.
92
Under FDCA Section 403(I), a producer of a food product is
required to describe the product by its common name or appropriately
descriptive term if there is no common name.
93
Furthermore, the
producer is required to reveal all facts that are material to the labeling
of the products or the consequences that might result from the use of
its product.
94
If a food that is derived from a new plant variety differs
from its traditional counterpart so much that the common name no
longer applies to the food, consumers must be informed by
appropriate labeling.
95
Consumers must also be informed by such
labeling if there is a safety issue that they must be made aware of.
96
In its 1992 Statement of Policy, the FDA used the example of a
tomato, which had a peanut protein introduced into it, to illustrate its
positioning on the labeling of GMOs.
97
The FDA stated that it would
require a label declaration for these tomatoes in order to alert peanut-
allergic consumers if there was not sufficient evidence to show that
the introduced peanut protein could not cause an allergic reaction in a
susceptible population.
98
This is because the information is a material
fact “whose omission may make the label of the tomato misleading
under section 403(a) of the act.”
99
In light of its findings, the FDA
ruled that it had not considered the methods used in developing a new
plant variety to be “material information” within FDCA Section
92. See infra notes 455-89 and accompanying text (analyzing S. 764 and the
circumstances surrounding it).
93. See 21 U.S.C. § 343(i) (2010) (stating the requirements for describing food either
with its common name or an appropriately descriptive term); 1992 FDA Statement of Policy,
supra note 25, at 22991 (detailing how foods must be described under section 403(i) of the
FDCA).
94. See 1992 FDA Statement of Policy, supra note 25, at 22991.
95. Id.
96. See id. (explaining these requirements under the Policy).
97. Id. (using the example of a tomato that had a peanut protein introduced into it to
explain its stance on GMO labeling).
98. See id. (detailing how the FDA would require labeling of a tomato with peanut
protein introduced into it since this would be a material fact whose omission would make the
tomato label misleading under 403(a) of the FDCA).
99. Id. (giving the FDA’s reasoning).
2017] GMO LABELING IN THE US AND EU 647
201(n).
100
The FDA also noted that it was not aware of any
information demonstrating that foods derived by such new methods
differ from other foods in any meaningful or uniform way or that “as
a class, food developed by the new techniques present any different or
greater safety concerns than foods developed by traditional plant
breeding.”
101
Thus, the FDA did not believe that the method of
development of a new plant variety, including those using
recombinant DNA techniques, is material information within the
meaning of the act and therefore did not require the information to be
disclosed in the food label.
102
Since the FDA has not modified its
stance on GMOs or reinvestigated the issue, the 1992 FDA Statement
of Policy has been the governing policy on GMO labeling until the
enactment of S. 764 and is the reason why the United States has not
required labeling of GMO products until 2016.
103
5. The FDA’s Decision Not to Define “Natural”
In addition to its decision to not mandate GMO labeling, the
FDA has also refused in the past to issue a formal definition of the
word “natural.”
104
While “natural” is the most widely used food label
on US food products, the term has only been informally defined by
the FDA.
105
The Third Circuit held that the definition does not have
the force of law.
106
In Holk v. Snapple Beverage Corp., the US Court
100. Id. (describing the agency’s findings).
101. Id. (stating the agency’s position on the method of genetic engineering with respect
to labeling the final product).
102. Id. (providing the FDA’s decision not to mandate GMO labeling based on methods
of production).
103. See Nunziato, supra note 9, at 479 (stating that the FDA has not changed its policy
on GMOs since 1992). See generally Lundquist, supra note 39, at 831-34 (describing the
GMO regulatory framework through 2015).
104. See Muller, supra note 11, at 523 (stating that the FDA has never issued a formal
definition of “natural”); April L. Farris, The “Natural” Aversion: The FDA’s Reluctance To
Define A Leading Food-Industry Marketing Claim, And The Pressing Need For A Workable
Rule, 65 F
OOD & DRUG L.J. 403, 404-07 (2010) (describing the history behind the FDA’s
informal policy on defining “natural” and the agency’s refusal to formally define the term).
105. See Muller, supra note 11, at 523 (explaining that while “natural” is the most
widely used food label on US food products, the FDA has declined to formally define the
term); Farris, supra note 104, at 403-08 (discussing the popularity of “natural” on food
products and the history of the FDA’s stance on defining “natural”).
106. See Holk v. Snapple Beverage Corp., 575 F.3d 329, 342 (3d Cir. 2009) (stating the
court’s belief that the 1992 FDA Statement of Policy regarding the use of the term “natural”
648 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
of Appeals for the Third Circuit ruled that the definition was not
binding and therefore could not be imposed on manufacturers because
the FDA stated its intention not to create a formal definition and
because the FDA promulgated the informal definition without public
notice and comment.
107
As a result of the FDA’s decision not to formally define
“natural,” many consumers have sued companies for using the term
“natural” on food products that contain GMOs or genetically
modified based ingredients.
108
By refusing to craft a formal definition
of “natural,” the FDA has not decided whether foods containing
genetically bioengineered ingredients can be labeled as “natural,” “all
natural,” or “100% natural,” essentially leaving this issue to the
federal courts.
109
However, as the courts do not necessarily possess
the requisite expertise to answer these questions, many have stayed
the litigation pending FDA answers.
110
During 2014, when two cases
were pending in the district courts of California and one case was
pending in New Jersey, the FDA wrote a letter to the three district
court judges hearing the cases, stating that this issue would not be
appropriate to decide in litigation since it is complex and concerns
does not have the force of law); Muller, supra note 11, at 523 (citing Holk, in which the Third
Circuit held that the FDA’s informal definition of “natural” does not have the force of law).
107. See Holk, 575 F.3d at 341-42 (detailing the court’s reasoning in its decision to rule
that the 1992 FDA Statement of Policy regarding the use of “natural” did not have the force of
law required to preempt conflicting state law).
108. See Muller, supra note 11, at 524 (stating that many consumers have filed lawsuits
against companies who are labeling their products as “natural” despite using GMOs and giving
a general overview of some of the complications from this development); see also Nicole E.
Negowetti, Food Labeling Litigation: Exposing Gaps in the FDA’s Resources and Regulatory
Authority, B
ROOKINGS INST. 1 (June 2014), https://www.brookings.edu/wp-content/uploads/
2016/06/Negowetti_Food-Labeling-Litigation.pdf (commenting that between 2011 and June
2014, more than 150 food labeling class action lawsuits had been filed against food and
beverage companies by consumer advocacy groups and plaintiffs).
109. See Muller, supra note 11, at 524-25 (discussing the way in which the FDA’s
refusal to formally define “natural” has resulted in dispute at the litigation level); Stephanie Jill
Fogel, FDA declines to define “Natural”, DLA
PIPER (Jan. 8, 2014), https://www.dlapiper.
com/en/us/insights/publications/2014/01/fda-declines-to-define-natural/ (explaining the
significant cases in which the FDA’s informal definition is a source of contention).
110. See Muller, supra note 11, at 524-25 (describing how the courts do not have the
necessary expertise in this area); Fogel, supra note 109 (discussing the courts’ belief that the
“natural” claims require FDA expertise).
2017] GMO LABELING IN THE US AND EU 649
myriad interests.
111
FDA Assistant Commissioner for Policy Leslie
Kux explained that a discussion of using “natural” on GMO products
would be better suited to a public proceeding, including an issuance
of a regulation or formal guidance.
112
The FDA has responded to these lawsuits and the public outcry
for labeling reform with respect to the use of “natural.”
113
On
November 10, 2015, the agency announced its request for public
comments on the use of the term “natural” on food labeling.
114
From
November 12, 2015 until May 10, 2016, the FDA allowed the public
to provide information and public comment on three questions: (1)
whether it is appropriate to define the term “natural,” (2) if so, how
the agency should define “natural,” and (3) how the agency should
determine the appropriate use of the term on food labels.
115
Specifically, the FDA noted that it was taking this step in response to
three Citizens Petitions that asked the agency to define “natural” for
use in food labeling and one Citizen Petition that requested it to
prevent parties from using “natural” on food labels.
116
Additionally,
the FDA indicated that it received requests for administrative
determinations from some federal courts that had ongoing litigation
between private parties regarding whether food products containing
ingredients using genetic engineering or foods containing high
fructose corn syrup can be labeled as “natural.”
117
111. See Josh Long, FDA: Courts on Their Own in GMO “All Natural” Lawsuits, NAT.
PRODUCTS INSIDER (Jan. 8, 2014), http://www.naturalproductsinsider.com/news/2014/01/fda-
courts-on-their-own-in-gmo-all-natural-lawsui.aspx (describing the FDA letter to the three
district court judges in which the FDA declined to decide on the issue in the litigation setting);
Fogel, supra note 109 (examining the FDA letter and response to the lawsuits).
112. See Long, supra note 111 (analyzing the FDA’s refusal to resolve this issue in the
context of a lawsuit); Fogel, supra note 109 (highlighting the FDA’s statement that it declined
to determine when a food may be labeled “natural” in the private litigation setting and that it
would do so through formal administrative processes).
113. See infra notes 114-21 and accompanying text (describing the agency’s response).
114. See “Natural” on Food Labeling, FDA, http://www.fda.gov/Food/Guidance
Regulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm456090.htm
(last visited Jan. 9, 2016) [hereinafter FDA Request].
115. See id. (setting forth the questions that the agency is asking the public to comment
on).
116. See id. (putting forth some of the main motivation behind the FDA’s request).
117. See id. (explaining how the FDA is reacting to the requests from federal courts that
are dealing with lawsuits concerning the use of “natural” on food products with respect to
GMOs).
650 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
In its request, the FDA acknowledged that while it has never
issued a formal definition for natural, it has maintained a longstanding
policy concerning the use of this term in human food labeling in
which “natural” means “nothing artificial or synthetic (including all
color additives regardless of sources) has been included in, or has
been added to, a food that would not normally be expected to be in
that food.”
118
More importantly, the FDA stated that this policy was
not meant to address food production methods or manufacturing
methods.
119
This is clearly aligned with the Coordinated Framework,
in which the Reagan administration argued that GMO food products
were not to be analyzed by the processes by which they were made,
but rather by the product’s safety with respect to human health.
120
In
its request, the FDA also stated that it did not consider whether the
term “natural” should describe “any nutritional or other health
benefit.”
121
6. The FDA’s Position On Labels Indicating A Product’s Non-GMO
Status
While the use of the word “natural” on products containing
GMOs has been allowed for the last two decades, terms such as
“GMO free” or “not genetically modified” have not been so greatly
accepted by the FDA.
122
Until 2016, producers wishing to advertise
that their products were GMO free were required to comply with the
regulations that the FDA had imposed on the labeling of non-GMO
foods.
123
According to the FDA, claims such as “GMO free” and “not
genetically modified” are misleading and thus the food producer or
118. See id. (describing the informal definition that the agency has used in place of a
formal definition).
119. See id. (stating what the policy does not apply to).
120. See id.; see also supra notes 39-44 (discussing the Coordinated Framework).
121. FDA Request, supra note 114 (giving limitations to the request).
122. See Neil D. Hamilton, Forced Feeding: New Legal Issues In The Biotechnology
Policy Debate, 17 W
ASH. U. J.L. & POL’Y 37, 44 (2005) (discussing the FDA’s negative view
of such claims and stating that the FDA has ruled that using the terms “GM” or “GMO Free” is
misleading); Glasscock, supra note 35, at 237 (explaining how the FDA has imposed “strict”
limitations on the voluntary labeling of non-GM foods in the past).
123. See Glasscock, supra note 35, at 237 (highlighting the difficulty of labeling non-
GM foods as such under the current FDA requirements); Hamilton, supra note 122, at 44
(discussing the burden of proof placed upon manufacturers by the FDA concerning claims of
GMO free).
2017] GMO LABELING IN THE US AND EU 651
manufacturer must substantiate such voluntary claims.
124
Prior to S.
764, it followed that while producers and manufacturers who wished
to use the label “GMO free” or “not genetically modified” had to bear
the cost to take the steps to substantiate such labels, producers or
manufacturers were free to use the label “natural,” “all natural,” or
“100% natural” on GMO products, despite the fact that most US
consumers believe that such terms also mean “non-GMO.”
125
7. The 1992 FDA Statement of Policy Upheld by the Courts
While the 1992 FDA Statement of Policy has not been altered
since 1992, it has been challenged in court.
126
In the District of
Columbia in Alliance for Bio-Integrity v. Shalala, a non-profit
organization brought an action against the FDA for its labeling
guidelines.
127
Ultimately, the court upheld the 1992 FDA Statement of
Policy since the decision to not mandate GMO labeling was not
arbitrary or capricious.
128
In this suit, plaintiffs argued that (1) the
statement was not properly subjected to notice-and-comment
procedures and (2) both the FDA’s presumption that genetically
modified foods were GRAS and its decision not to require labeling
was arbitrary and capricious, and therefore should be set aside by the
court.
129
The FDA argued that since its statement was a policy
statement or an interpretive rule, it was not subject to formal notice
and comment requirements.
130
The United State District Court for the
District of Columbia ruled that as evidenced by the name and plain
124. See Hamilton, supra note 122, at 44 (explaining how the FDA determined that
using “GMO free” and “GM” is misleading); Glasscock, supra note 35, at 237 (stating that
under the 1992 FDA Statement of Policy, manufacturers had to substantiate voluntary claims
of “non-genetically modified” and “GMO free”).
125. See Glasscock, supra note 35, at 237 (describing how the requirement prior to S.
764 that manufacturers and producers substantiate claims of “not genetically modified” or
“GMO free” could be cost prohibitive); Farris, supra note 104, at 405-06 (explaining the
informal definition of “natural” by the FDA).
126. See Nunziato, supra note 9, at 479 (stating that the FDA has not changed its
position since 1992); Alliance for Bio-Integrity v. Shalala, 116 F.Supp.2d 166 (D.D.C. 2000)
(where the plaintiffs challenged the FDA’s stance on GMO labeling).
127. See Shalala, 116 F.Supp.2d 166.
128. Id. at 177 (explaining the court’s holding that the 1992 FDA Statement of Policy
was not arbitrary or capricious).
129. Id at 173 (explaining plaintiffs’ claims).
130. Id. (detailing the FDA’s arguments).
652 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
language of the statement, the 1992 Statement of Policy creates a
rebuttable presumption of GRAS and exists as a policy statement.
131
Thus, the court ruled, the FDA did not err in implementing its 1992
Statement of Policy without formal notice and comment.
132
In deciding whether or not the agency acted arbitrarily and
capriciously in presuming that GMOs were GRAS and deciding not to
label such products, the court used the Chevron analysis, which is a
legislation and regulation tool that courts use to analyze agency action
in a lawsuit against the agency.
133
In performing this analysis, the
court examined the Food Additives Amendment to the FDCA and
found that though the 1958 Congress could not conceive of GMOs at
the time the amendment was made, the statute exempts substances
that are “generally recognized . . . to be safe under the conditions of
its intended use” from regulations as additives.
134
The court
highlighted the fact that the plaintiffs were not disputing the FDA’s
claim that nucleic acid proteins are generally recognized to be safe,
but rather that the FDA presumed GMOs as GRAS in light of
“significant disagreement” among scientists as to whether nucleic
proteins are generally recognized as safe when used to alter organisms
genetically.
135
The court noted that it had to proceed with particular
caution in order to avoid directing the agency in a choice between
rational alternatives.
136
Furthermore, the court ruled that in analyzing
the agency’s determination of GRAS, its review is confined to the
131. Id. (explaining the court’s basis for determining the status of the statement).
132. Id. (discussing the court’s ruling concerning the legality of the FDA’s
administrative process in implementing its Statement of Policy).
133. Id at 176 (describing how the court’s examination of the FDA’s interpretation is
“framed by” the case Chevron, U.S.A. v. Natural Resources Def. Council, 467 U.S. 837
(1984)).
134. 21 U.S.C. § 321(s) (2009); see Shalala, 116 F.Supp.2d at 177 (quoting 21 U.S.C. §
321(s) to describe the FDA’s inability to regulate substances that are recognized as GRAS as
additives under the FDCA).
135. See Shalala, 116 F.Supp.2d at 177 (explaining that the plaintiffs’ argument
concerning disagreement among experts concerning the GRAS status of nucleic acid proteins
was not the same as disputing the FDA’s claim that nucleic acid proteins are GRAS, which
plaintiffs did not do).
136. Id. (quoting Int’l Fabricare Inst. v. U.S.E.P.A., 972 F.2d 384, 389 (D.C. Cir. 1992)
to describe the justification behind deferring to an agency when it is evaluating scientific data
that is within its technical expertise, and Env’t Def. Fund, Inc. v. Costle, 578 F.2d 337, 339
(D.C. Cir. 1978) to explain how the court is supposed to judge the matter cautiously as to not
direct the agency when a choice is made between rational alternatives).
2017] GMO LABELING IN THE US AND EU 653
record before the agency at the time it made its decision, and that
while unanimity among scientists is not necessary, “a severe conflict
among experts . . . precludes a finding of general recognition.”
137
In
light of all of these considerations, the court found that the plaintiffs
did not show that the GRAS determination was inconsistent with the
statutory requirements, and therefore it was not arbitrary and
capricious.
138
Through this analysis, the court found that the FDA’s decision
not to include consumer interests in the factors used to determine
whether a change is “material” constituted a reasonable interpretation
of the statute.
139
The court reasoned that because the FDA found that
rDNA modification does not “materially” alter food, the agency does
not have a basis for legally requiring labeling, despite a level of
consumer demand for it.
140
Also, the court deferred to the FDA’s
determination that foods produced with rDNA modification
techniques do not present any different or greater safety concerns than
foods that come from traditional plant breeding, and that mandatory
labeling is not warranted.
141
Since the court did not find this decision
to be irrational, it ruled that the FDA’s decision not to require GMO
labeling was not arbitrary and capricious and upheld the agency
action.
142
Since the FDA has not reexamined the issue of requiring GMO
labeling since 1992, the 1992 Statement of Policy that was upheld by
137. See Substances Generally Recognized as Safe, 62 Fed. Reg. 18938-01 (Apr. 17,
1997); Shalala, 116 F.Supp.2d at 177 (quoting Substances Generally Recognized as Safe to
describe how a GRAS finding is not permitted if there is a severe conflict among experts and
also explaining how the court must only review the record before the FDA at the time it made
its decision).
138. See Shalala, 116 F.Supp.2d at 177 (stating that the court’s finding that the GRAS
presumption is not inconsistent with the statutory requirements).
139. See id. (explaining that the FDA’s interpretation of the statute with respect to
excluding consumer choice as a factor that determines whether a change is “material” was
reasonable).
140. See id. (asserting that the FDA cannot legally require labeling without finding that
rDNA modification materially alters food).
141. See id. (explaining that the FDA’s determination that rDNA derived foods do not
present any different or greater safety concern than foods developed by traditional plant
breeding is entitled to deference unless it is irrational).
142. See id. (setting forth the court’s ruling).
654 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
the Shalala court is still in effect.
143
While the FDA’s position on
GMOs has not substantially changed in over twenty years, the US
attitude towards GMOs has dramatically shifted from neutrality
towards skepticism.
144
Three states, including Connecticut and
Vermont, enacted their own labeling laws that essentially
circumvented the FDA’s stance on GMO labeling laws.
145
It appeared
that this inconsistent dichotomy would continue in the absence of
federal action, as more states looked to enact their own GMO labeling
laws in opposition to the FDA’s position under its 1992 Statement of
Policy.
146
However, as discussed in Part II of this Note, the
implementation of federal GMO labeling requirements under S. 764
has resolved this conflict and avoided a patchwork system of state
GMO labeling laws.
147
While the 1992 Statement of Policy is still
valid, the federal government has placed the regulation of GMO
labeling in the hands of the USDA despite objection by the FDA.
148
It
is not clear how this system under S. 764 will exist in the shadow of
the 1992 Statement of Policy, as the very requirement of GMO
143. See Nunziato, supra note 9, at 479 (stating that the FDA has not changed its
position since 1992); Marden, supra note 17, at 756 (detailing how the decision “. . . made it
clear that critics of the FDA’s policy had very little legal ground on which to stand”).
144. See Kate Galbraith, Attitudes on Crops Are Modifying, NY
TIMES (July 10, 2013),
http://www.nytimes.com/2013/07/11/business/energy-environment/11iht-green11.html?_r=0
(discussing the rise in consumer interest in food and dietary issues in recent years, which has
led to the labeling initiatives). See generally Cary Funk & Lee Rainie, Chapter 6: Public
Opinion About Food, P
EW RES. CTR. (July 1, 2015), http://www.pewinternet.org/2015/07/01/
chapter-6-public-opinion-about-food/ (providing a Pew Research survey on public perception
of GMOs in the United States).
145. See Philip Brasher, FDA Refuses To Require GMO Labeling, A
GRI-PULSE (Nov.
19, 2015), http://www.agri-pulse.com/FDA-refuses-to-require-GMO-labeling-11192015.asp
(explaining how the FDA still refuses to mandate GMO labeling); Mary Clare Jalonick, A
Senate Committee Is Moving Forward On Legislation That Would Prevent States From
Requiring Labels On Genetically Modified Foods, US
NEWS & WORLD REP. (Feb. 19, 2016,
7:26 PM), http://www.usnews.com/news/business/articles/2016-02-19/senate-bill-would-
block-mandatory-labeling-of-gmos (discussing the measures taken by these three states).
146. See infra Section II.A (providing an overview of this state movement).
147. See infra Section II.A.9 (discussing how S. 764 eliminated the patchwork system of
GMO labeling laws by prohibiting state GMO labeling laws and preempting the laws of
Connecticut, Maine, and Vermont).
148. See infra Sections II.A.9 and II.A.10 (explaining how S. 764 places the GMO
labeling system within the power of the USDA and the criticism facing this assignment).
2017] GMO LABELING IN THE US AND EU 655
labeling under the law conflicts with the FDA’s long held policy that
GMOs should not be labeled due to their GRAS status.
149
B. EU Regulation of GMOs: Product, Labeling, and Marketing
This Section explains EU regulation of GMOs and its foundation
in the precautionary principle. Section I.B.1 explains the
precautionary principle and EU environmental policy, while Section
I.B.2 examines the fundamental ideas of the precautionary principle.
Section I.B.3 examines how the Commission applies the
precautionary principle and Sections I.B.4 and I.B.5 discuss two
crucial cases that elaborate on the precautionary principle. Section
I.B.7 details the regulatory system prior to 2001 through the 1990
Deliberate Release Directive and the problems associated with the
Directive, including a de facto moratorium on GMOs in the European
Union in 1998 and the public’s intense demand for mandatory GMO
labeling.
150
Sections I.B.8 and I.B.9 describe EU GMO regulation
after 2001 under the 2001 Deliberate Release Directive and the
Genetically Modified Food and Feed Regulation, while Section
I.B.10 sets out the GMO labeling requirements under the Traceability
and Labeling Regulation.
151
Finally, Section I.B.11 summarizes and
compares the GMO regulatory systems of the United States and the
European Union.
Citizens of the European Union have been wary of the effects of
GMOs on human health and the environment since the agricultural
product industry began genetically engineering food.
152
Despite
149. See supra Section I.A.3 (explaining the FDA position).
150. See Council Directive 90/220//EEC on the Deliberate Release into the Environment
of Genetically Modified Organisms, 1990 O.J. L 117/15 [hereinafter 1990 Deliberate Release
Directive].
151. See Council Directive 2001/18/EC on the Deliberate Release into the Environment
of Genetically Modified Organisms and Repealing Council Directive 90/220/EC, 2001 O.J. L
106/1 [hereinafter 2001 Deliberate Release Directive]; Council Regulation 1829/2003/EC on
Genetically Modified Food and Feed, 2003 O. J. L 268/1 [hereinafter Genetically Modified
Food and Feed Regulation]; Council Regulation 1830/2003/EC on the Traceability and
Labeling of Genetically Modified Organisms and the Traceability of Food and Feed Products
Produced from Genetically Modified Organisms and Amending Directive 2001/18/EC, 2003
O.J. 18/10/2003 [hereinafter Traceability and Labeling Regulation].
152. See The EU-US Dispute over GMOs: Risk Perceptions and the Quest for
Regulatory Dominance, supra note 32 (describing the negative opinion of the EU public
656 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
having the second largest amount of arable land in the world, the
European Union grows less than one percent of the world’s
genetically modified crops.
153
The EU GMO regulatory system has
been described as among the strictest in the world and is known for
providing a high level of scientific assessment, while simultaneously
safeguarding the consumer’s right to choose.
154
1. The Precautionary Principle & EU Environmental Policy
In sharp contrast to the United States’ decision to regulate
GMOs within existing statutory systems under the Coordinated
Framework, the European Union’s GMO regulatory system is based
upon several specific legislative measures that monitor and restrict the
growth, cultivation, and marketing of GMOs.
155
As opposed to the US
system that is based on the substantial equivalence doctrine, the EU
regulatory system is founded upon the precautionary principle.
156
The
precautionary principle presumes that if an activity may have
environmentally harmful consequences, it is better to take action
before it is too late instead of waiting until complete scientific
regarding GMOs and genetic engineering); Wilinska, supra note 19, at 155-56 (highlighting
the skepticism of EU consumers and their distrust in government food safety regulations).
153. See Laura Moore Smith, Divided We Fall: The Shortcomings of the European
Union’s Proposal for Independent Member States to Regulate the Cultivation of Genetically
Modified Organisms, 33 U.
PA. J. INT’L L. 841, 841 (2011-2012) (stating the fact that the
European Union grows less than one percent of the world’s genetically modified crops despite
having the second largest amount of arable land in the world); Debra M. Strauss, Feast or
Famine: The Impact of the WTO Decision Favoring the U.S. Biotechnology Industry in the EU
Ban of Genetically Modified Foods, 45 A
M. BUS. L.J. 775, 778 (2008) (giving the statistics of
the EU land and GMO cultivation as of 2008).
154. See Rachele Berglund Bailey, A Tale of Two Systems: A Comparison Between US
and EU Labeling Policies of Genetically Modified Foods, 15 S
AN JOAQUIN AGRIC. L. REV.
193, 205 (2012) (highlighting this dichotomy of stringent scientific requirements and the
protection of the consumer right to choose); see also Joss, supra note 16, at 147 (describing the
strictness of the EU GMO regulatory system).
155. See generally 2001 Deliberate Release Directive, supra note 151; Genetically
Modified Food and Feed Regulation, supra note 151; Traceability and Labeling Regulation,
supra note 151.
156. See Elizabeth G. Hill, Nature’s Harvest Or Man’s Profit: Environmental Shortcuts
In The Deregulation Of Genetically Modified Crops, 44 T
EX. TECH. L. REV. 353, 360 (2012)
(stating that the European Union adopted an approach to GMOs based on the precautionary
principle); Marden, supra note 17, at 735 (explaining how the European Commission has
taken a precautionary approach towards the technology of genetically modified foods).
2017] GMO LABELING IN THE US AND EU 657
evidence can indisputably prove the causal connection.
157
The major
difference in policy provides the explanation for the stark differences
between the two regulatory systems and explains why the European
Union has such strict labeling requirements for GMOs.
158
On July 1, 1987, the Single European Act (“SEA”) became
effective and amended the European Economic Community Treaty
(“EEC”), which established the European Economic Community in
1957.
159
Among the amendments found in the SEA, Article 130r
provided the basis for environmental action taken by the
Community.
160
According to Article 130r, the objectives of
Community action relating to the environment were to preserve,
protect, and improve the quality of the environment, as well as
contribute towards protecting human health and ensure a prudent and
rational utilization of natural resources.
161
Specifically, Community
action relating to the environment was to be based on the principles
that preventive action should be taken, environmental damages should
be rectified at the source, and that the polluter should pay.
162
In order
to achieve these goals, the Community had to take into account four
pieces of information, some of which included available scientific
data and the potential benefits and costs of action or lack of action.
163
157. See JAN H. JANS & HANS H.B. VEDDER, EUROPEAN ENVIRONMENTAL LAW AFTER
LISBON 41 (4
th
ed. 2012) (describing the presumption of the precautionary principle that taking
preventative action and avoiding damage is better than not taking such action in order to wait
until complete scientific evidence becomes available that demonstrates the causal connection);
A
LBERTO ALEMANNO, TRADE IN FOOD: REGULATORY AND JUDICIAL APPROACHES IN THE EC
AND THE
WTO 106 (2007) (claiming that under the precautionary principle, it is preferable to
not wait for a risk to materialize before examining and withdrawing a product whose safety is
uncertain from the market).
158. See Debra M. Strauss, Genetically Modified Organisms in Food: A Model with
Positive Implications for International Trade, 40 I
NT’L L. 95, 115 (2006) (noting the
contrasting approaches to GMO regulation of the United States and European Union); see also
Bailey, supra note 154, at 208-09 (analyzing the differences between the US and EU
regulatory systems, specifically in approaches to labeling requirements, and the reasons behind
such differences).
159. See Single European Act, 1987 O.J. L 169/1, [hereinafter SEA] (amending Treaty
Establishing the European Economic Community, March 25, 1957, 298 U.N.T.S. 11
[hereinafter EEC Treaty]).
160. Id. art. 130r.
161. Id. at 1.
162. Id. at 2.
163. Id. at 3.
658 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
Under the Treaty of Maastricht, which was effective on
November 1, 1993, the EEC Treaty was revised and renamed the
European Community Treaty (“ECT”).
164
Expanding upon the SEA
requirements for environment action, the new provisions provided
that Community policy on the environment shall be based on the
precautionary principle, in addition to the previous policies that were
provided in Article 130r of the SEA.
165
Article 130r of the Treaty of
Maastricht also provided that environmental protection requirements
were to be integrated into other Community policies’ definition and
implementation.
166
Finally, it stated that in this context, harmonization
procedures with respect to these requirements needed to include a
safeguard clause that allowed the Member States to take provisional
measures for non-economic environmental reasons where
appropriate.
167
These measures were also required to be subject to a
Community inspection procedure.
168
The next major revision of the basic treaties occurred on
November 1, 2009, when the Lisbon Treaty on European Union came
into effect, which modified the Maastricht Treaty.
169
The EEC Treaty
was renamed the Treaty on the Functioning of European the Union
(“TFEU”) and all references to the European Community were
replaced with the “European Union.”
170
It is under Article 191 of the
TFEU that the current instructions for EU policy on the precautionary
principle are found.
171
According to Article 191, EU policy on the
environment shall be based upon the precautionary principle, in
addition to the principles of prevention, that environmental damage
should be rectified at the source, and that the polluter should pay.
172
164. See Treaty on European Union (Maastricht text), July 29, 1992, 1992 O.J. C 191/1
[hereinafter Maastricht TEU].
165. Id. art. 130r, at 2 (requiring Community environmental policy to be based on the
precautionary principle).
166. Id.
167. Id.
168. Id.
169. See generally Consolidated Version of the Treaty on the Functioning of the
European Union, 2008 O.J. C 115/47 [hereinafter TFEU].
170. See generally id.
171. Id. art. 191.
172. Id. at 2.
2017] GMO LABELING IN THE US AND EU 659
2. The Fundamentals Of The Precautionary Principle
The idea behind the precautionary principle is that governments
should be able to take preventative action in order to prevent
potentially serious environmental harms when the scientific findings
concerning a possible causal connection are not completely certain.
173
The precautionary principle presumes that if there is a strong
suspicion that an activity may be environmentally harmful, it is better
to take action before it is too late instead of waiting to act for
scientific evidence to become available that shows a causal
connection.
174
While a causal link has not been clearly formed based
on available scientific evidence, an action that is taken in order to
prevent damage in this instance can be supported by the precautionary
principle.
175
Risk assessment is the key to the precautionary principle.
176
In
view of risk assessment, not all preventative actions are completely
justified by the precautionary principle.
177
Instead, the precautionary
173. See JANS & VEDDER, supra note 157, at 43 (articulating the precautionary principle
and what it requires of government with respect to preventing environmental harms in the face
of uncertain scientific findings); A
LEMANNO, supra note 157, at 105 (characterizing the
precautionary principle as allowing the adoption of protective measures in circumstances
where there is scientific uncertainty).
174. See J
ANS & VEDDER, supra note 157, at 43 (describing the presumption of the
precautionary principle that taking preventative action and avoiding damage is better than not
taking such action in order to wait until complete scientific evidence becomes available that
demonstrates the causal connection); A
LEMANNO, supra note 157, at 106 (claiming that under
the precautionary principle, it is preferable to not wait for a risk to materialize before
examining and withdrawing a product from the market whose safety is uncertain).
175. See J
ANS & VEDDER, supra note 157, at 43 (showing a possible justification under
the precautionary principle for taking action without scientific certainty concerning a causal
connection); A
LEMANNO, supra note 157, at 106 (“ . . . recourse to the precautionary principle
presupposes that scientific evaluation does not allow the risk to be determined with sufficient
certainty.”).
176. See J
ANS & VEDDER, supra note 157, at 43 (specifying that the Commission
guidelines indicate that the precautionary principle is all about risk management); Joss, supra
note 16, at 147 (stating that the precautionary principle “necessitates” that risk assessment be
conducted when introducing biotechnology).
177. See Council Regulation 178/2002/EC on Laying Down The General Principles And
Requirements Of Food Law, Establishing The European Food Safety Authority and Laying
Down Procedures In Matters Of Food Safety, 2002 O.J. L 31/1, art. 7, at 2 [hereinafter
General Principles and Requirements of Food Law Regulation] (explaining the boundaries of
the precautionary principle); J
ANS & VEDDER, supra note 157, at 43 (discussing how the
precautionary principle justifies actions taken).
660 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
principle calls for proportion between the measures taken and the
chosen level of protection that is determined when action is deemed
necessary.
178
Because the precautionary principle is applied when scientific
uncertainty exists, a proper risk assessment is paramount and must be
performed as part of a correct application of the principle.
179
A correct
application of the precautionary principle requires, first, that the
potentially negative health consequences of a proposed use of the
substance be identified and that a comprehensive risk assessment
based on the most reliable scientific data be conducted.
180
Under the
precautionary principle, a hypothetical risk will not be an adequate
basis for action.
181
Rather, action is only justified if it is deemed
necessary in order to ensure that there is no danger for the
environment and human health as shown by a prior complete risk
assessment.
182
178. See General Principles and Requirements of Food Law Regulation, supra note 177,
art. 7, at 2 (stating that measures adopted on the basis of the precautionary principle that are
necessary to ensure the high level of health protection “. . . shall be proportionate and no more
restrictive of trade than is required to achieve the high level of health protection chosen in the
Community, regard being had to technical and economic feasibility and other factors regarded
as legitimate in the matter under consideration”); J
ANS & VEDDER, supra note 157, at 43
(detailing how measures taken under the precautionary principle should be proportional to the
chosen level of protection).
179. See Joss, supra note 16, at 147 (explaining how risk assessment is necessary under
the precautionary principle); General Principles and Requirements of Food Law Regulation,
supra note 177, art. 6 (describing the necessity of risk assessment).
180. See J
ANS & VEDDER, supra note 157, at 44 (detailing the viewpoint of the Court of
Justice of what constitutes a correct application of the precautionary principle); see also infra
Section II.B.3 (setting forth the parameters for the precautionary principle as set forth by the
Commission).
181. See Ruby R. Fernandez, Monsanto And The Requirement For Real Risks In GM
Food Regulation, 28 L
OY. L.A. INT’L & COMP. L. REV. 335, 338 (2006) (detailing how risk
assessments must be conducted on real, perceived risks and not hypothetical risks); J
ANS &
VEDDER, supra note 157, at 44 (highlighting the need for risk assessment to be conducted on
real risks as opposed to hypothetical risks).
182. See J
ANS & VEDDER, supra note 157, at 45 (explaining the prohibition of justifying
action based on a hypothetical risk); Fernandez, supra note 181, at 345 (discussing the
requirements of the precautionary principle); Claudio Mereu, Schizophrenic Stakes of GMO
Regulation in the European Union, 3 E
UR. J. RISK REG. 202, 207 (2012) (explaining how a
complete risk assessment must be conducted before a Member State can impose a ban).
2017] GMO LABELING IN THE US AND EU 661
3. The Precautionary Principle As Explained By The Commission
As discussed by the Commission of the European Communities
in its Communication on the Precautionary Principle, the issue on
when and how to use the precautionary principle is a contentious
topic and has led to some mixed views concerning the principle.
183
Through the Commission Communication, the Commission outlined
its approach to using the precautionary principle and established
guidelines for its application.
184
The Commission desired to craft a
common understanding on how to manage risks that have not been
fully evaluated by science and to avoid the use of the principle as a
disguised form of protectionism.
185
Within this approach, the
precautionary principle should be considered within a structured
approach to risk analysis, which is made up of risk assessment, risk
management, and risk communication.
186
The precautionary principle
is specifically relevant to the management of risk.
187
In this risk
analysis, the precautionary principle should be resorted to when
potentially dangerous effects of a phenomenon, process, or product
have been identified and the risk cannot be determined with sufficient
certainty under a scientific evaluation.
188
Specifically, the
precautionary principle is only relevant in the situation of a potential
risk, even if the risk is not fully demonstrable because of insufficient
or inclusive scientific data.
189
In order to determine if measures are
necessary to protect human, animal, or plant health, as well as the
environment, an evaluation of the potential negative effects using
available data is required.
190
The Commission Communication gives
guidance on how to perform this evaluation.
191
Determining what is
an acceptable level of risk for society and what an appropriate
183. Commission of the European Communities, Communication from the Commission
on the Precautionary Principle, COM (2000) 1 Final [hereinafter Commission
Communication].
184. Id. at 2, ¶ 1.
185. Id.
186. Id. at 2, ¶ 4.
187. Id.
188. Id. at 3, ¶ 4.
189. Id. at 13, ¶ 5.1.
190. Id. at 13, ¶ 5.1.2.
191. Id. at 13-15.
662 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
response might be are both political determinations.
192
Those making
these political determinations may either adopt measures to respond
or decide to do nothing in response and leave things status quo.
193
According to the Commission Communication, once action is
deemed necessary, measures taken based on the precautionary
principle should be (1) proportional to the chosen level of protection,
(2) non-discriminatory in their application, (3) consistent with similar
measures already taken, (4) based on an examination of the potential
benefits and costs of action or lack of action, (5) subject to review in
light of new scientific data, and (6) capable of assigning responsibility
for producing the scientific evidence necessary for a more
comprehensive risk assessment.
194
Particularly important is the
proportionality requirement, as a total ban of something may be the
only possible response to a certain risk, but also may not be
proportional to a potential risk in every case.
195
4. The Precautionary Principle & Monsanto
In Monsanto Agricoltura Italia SpA v. Presidenza del Consiglio
dei Ministri, the European Court of Justice (“Court of Justice”)
closely examined the application of the precautionary principle and
how the principle can be used to justify Member State actions.
196
At
the time of this case, genetically modified foods and food derived
from GMOs were regulated as novel foods and had to be authorized
under the Novel Foods Regulation (described in more detail later in
this Note).
197
Under the second recital of the Novel Foods Regulation,
a simplified procedure existed for the authorization of foodstuffs that
were produced from GMOs but did not contain them in the final
product.
198
All that was required under this simplified procedure was
192. Id. at 15, ¶ 5.2.1.
193. Id.
194. Id. at 3, ¶ 5.
195. Id.
196. Monsanto Agricoltura Italia SpA and Others v. Presidenza del Consiglio dei
Ministri and Others v. Presidenza del Consiglio dei Ministi and Others, Case C-236/01 [2003]
E.C.R. I-8166.
197. See Council Regulation No 258/97/EC Of the European Parliament and of the
Council of 27 January 1997 Concerning Novel Foods and Novel Food Ingredients, 1997 O.J. L
43/1 [hereinafter Novel Foods Regulation].
198. Id. recital 2.
2017] GMO LABELING IN THE US AND EU 663
notification to the Commission.
199
This procedure could be used when
the products were substantially equivalent to similar conventional
foods with regard to their intended use, composition, nutritional
value, and the level of undesirable substances contained within
them.
200
Between December 1997 and October 1998, Monsanto and other
companies submitted three notifications to the Commission under the
simplified procedure for food produced from different genetically
modified maize lines on the market.
201
Along with the notifications
was an opinion of the UK scientific assessment body that found that
the products at issue were substantially equivalent to traditional maize
and safe for use in food, such as corn flour.
202
Italy objected several
times about the use of the simplified procedure to the Commission,
arguing that the products were not substantially equivalent to their
traditional counterparts.
203
Despite the correspondence with the
Commission, Italy adopted a Decree based on the safeguard clause of
the Novel Foods Regulation that suspended the trading and use of
certain transgenic products within its national territory.
204
Under this
safeguard clause, a Member State could temporarily restrict or
suspend the trade in and use of a food or food ingredient in question
in its territory if it had detailed grounds for considering it to endanger
human health or the environment based on new information or a
reassessment of existing information.
205
The Commission responded
by consulting with the Scientific Committee on Food in accordance
with Article 11 of the Novel Foods Regulation to inspect the opinions
submitted by Italy when it objected to the simplified procedure.
206
The Scientific Committee on Food found that Italy’s information did
not provide specific scientific grounds for considering that the use of
the novel foods in question endangered human health.
207
While the
199. Id. art. 3, at 4 (setting forth the simplified procedure).
200. Id.
201. Monsanto, supra note 196, at ¶ 18.
202. Id. ¶ 19.
203. Id. ¶ 32-33.
204. Id. ¶ 31.
205. Id.; Novel Foods Regulation, supra note 197, art. 12, at 1 (providing the safeguard
clause).
206. Monsanto, supra note 196, ¶ 34.
207. Id. ¶ 35.
664 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
Commission presented a draft decision contesting the Italian decree to
the Standing Committee on Foodstuffs, the Commission did not go to
a formal vote (largely because of the de facto moratorium on GMOs
that was ongoing in the European Union).
208
Companies such as
Monsanto challenged the Italian Decree before the Tribunale
amministrativo regionale del Lazio (“TAR”).
209
They claimed that it
violated Community law and that Italy inadequately relied on the
safeguard clause under Article 12 of the Novel Foods Regulation.
210
The TAR stayed its proceedings and referred questions to the Court of
Justice for a preliminary ruling concerning the invoking of the
safeguard clause, the validity of the simplified procedure, and
whether a GMO-derived novel food could be regulated by the
simplified procedure as substantially equivalent.
211
The court held that under Article 12 of the Novel Foods
Regulation, Member States could not submit a general risk
assessment.
212
Rather, a Member State could only meet the burden of
proof if it relied on the evidence that showed the existence of a
specific risk of the novel food at question.
213
Additionally, the
safeguard clause was interpreted as giving specific expression to the
precautionary principle and, as such, the application of the clause was
required to have “due regard to this principle.”
214
Under the
precautionary principle, when there is uncertainty about the existence
or amount or risk to human health, protective measures can be taken
without having to wait for the reality and seriousness of such risks to
become fully apparent.
215
Thus, under Article 12 of the Novel Foods
Regulation and the precautionary principle, protective measures could
be taken even if it was impossible to carry out a full risk assessment
with respect to a specific food because of the inadequate nature of the
available scientific data.
216
However, the court specifically held that
208. Id. ¶¶ 35-37
209. Id. ¶¶ 40, 48 (explaining the procedural history and giving the questions posed by
TAR).
210. Id. ¶¶ 44-49.
211. Id.
212. Id. ¶ 108.
213. Id. ¶ 109.
214. Id. ¶ 110.
215. Id. ¶ 111.
216. Id. ¶ 112.
2017] GMO LABELING IN THE US AND EU 665
under the safeguard clause, protective measures could not be adopted
based on a purely hypothetical approach to risk.
217
Under the clause, a
Member State had to perform a risk assessment that was complete as
possible and find that the implementation of such measures was
necessary to ensure that novel foods did not present a danger to the
consumer.
218
Ultimately, the court rejected Italy’s argument that the simplified
procedure resulted in a relaxation of the safety requirements for novel
foods that had been justified as substantially equivalent.
219
This, the
court reasoned, was because there were many other procedures within
Community law to ensure the safety of novel foods, such as the
Safeguard Clause and re-assessment of the status of a GMO product
at the Community level.
220
The court also found that the simplified
procedure complied with the idea of proportionality.
221
5. The Precautionary Principle & Commission v. Denmark
The fundamental ideas behind the precautionary principle were
demonstrated by the Court of Justice in Commission v. Denmark,
when Denmark partly relied on the principle to support its
administrative practice that only allowed enriched foodstuffs lawfully
produced or marketed in other Member States to be marketed in
Denmark if it was shown that the nutritional enrichment met a need in
the Danish population.
222
The Court of Justice found that the Danish
administrative practice violated Article 28 EC, which prohibits any
quantitative restrictions on imports between Member States and all
measures having equivalent effect.
223
The court addressed whether the
administrative practice could be justified on the basis of Article 30
EC, which allowed for a trade restriction if this would protect human
217. Id. ¶ 106.
218. Id. ¶ 114. The court also addressed whether the novel foods at issue could be
considered substantially equivalent to their traditional counterparts and what precludes a
finding of substantial equivalence. However, this discussion will not be addressed by this
Note.
219. Id. ¶ 80.
220. See generally id. ¶ 130-32.
221. Id.
222. See Commission v. Denmark, Case C-192/01, [2003] E.C.R. I-9724, ¶ 1 (describing
the factual background of the actions that led to the case).
223. Id. ¶ 39, 41.
666 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
health.
224
The Court of Justice held that depending on any
uncertainties in modern scientific research, it is up to the Member
States to decide their level of protection for human health and life.
225
Furthermore, it is up to the Member State’s discretion as to require
prior authorization for the marketing of foodstuffs, subject to
considering the requirements of free movement of goods within the
Community.
226
The Court of Justice determined that within this
discretion, Member States have to comply with the principle of
proportionality.
227
This means that the methods chosen by such a
Member State have to be restricted to what is actually necessary to
protect public health and also that such protection cannot be attained
by means less restrictive of Community trade.
228
Under the strict
exception under Article 30 EC to the rule of free movement of goods
within the Community, a Member State is required to show that its
rules are necessary and that the marketing of the product is a risk to
public health, in light of national nutritional habits and international
scientific research.
229
The Court of Justice stated that the decision to
prohibit marketing can only be adopted if the most current scientific
data sufficiently established the real risk.
230
In examining Denmark’s administrative action, the Court of
Justice clearly stated that “ . . . a proper application of the
precautionary principle presupposes, in the first place, the
identification of the potentially negative consequences for health of
the proposed addition of nutrients, and, secondly, a comprehensive
risk assessment of the risk to health based on the most reliable
scientific data available and the most recent results of international
research.”
231
The Court of Justice went further and addressed the
permissible justification of action based on the precautionary
principle and ruled that “where it proves to be impossible to
determine with certainty the existence or extent of the alleged risk
because of the insufficiency, inconclusiveness, or imprecision of the
224. Id. ¶ 42.
225. Id.
226. Id.
227. Id. ¶ 45.
228. Id.
229. Id. ¶ 46.
230. Id. ¶ 48.
231. Id. ¶ 51.
2017] GMO LABELING IN THE US AND EU 667
results of studies conducted, but the likelihood of real harm to public
health persists should the risk materialise, the precautionary principle
justifies the adoption of restrictive measures.”
232
The Court of Justice
also added that such measures are not allowed unless they are
objective and non-discriminatory.
233
Ultimately, the Court of Justice
found that the Danish administrative practice was disproportionate
since it prohibited the marketing of foodstuffs with added vitamins
and minerals without distinguishing among different vitamins and
minerals added or according to the level of risk that their addition
may pose to public health.
234
6. The 1990 Deliberate Release Directive
As previously discussed, provisions for Community policy on
the environment were provided in Article 130r of the SEA in 1987.
235
As these measures were in effect until 1993, the Council adopted the
1990 Deliberate Release Directive consistent with these provisions as
well the precautionary principle.
236
As a Directive, the 1990
Deliberate Release Directive was binding on all Member States.
237
But Member States had the ability to choose the forms and methods
used to implement the Directive.
238
Applicable to all GMOs, this
Directive pertained to then-modern biotechnology techniques, such as
microinjection of foreign genetic material and cell fusion that does
232. Id. ¶ 52.
233. Id. ¶ 53.
234. Id. ¶ 55.
235. See supra notes 158-63 and accompanying text (discussing the environmental
policy under SEA).
236. See Ruth MacKenzie & Silvia Francescon, The Regulation of Genetically Modified
Foods In The European Union: An Overview, 8 N.Y.U.
ENV’T L.J. 530, 533 (1999-2000)
(arguing that while the 1990 Deliberate Release Directive does not specifically mention the
precautionary principle, the approach taken in the Directive “ . . . is consistent with a
precautionary approach insofar as the Directive as a whole addresses the uncertain nature and
the extent of risks to the environment and human health associated with the use and release of
GMOs.”); Mereu, supra note 182, at 205 (articulating that the 1990 Deliberate Release
Directive was based on the precautionary principle).
237. See 1990 Deliberate Release Directive, supra note 150, art. 23, at 1 (requiring
Member States to bring laws, regulations, and administrative provisions necessary to comply
with the Directive into force before October 23, 1991).
238. See 1990 Deliberate Release Directive, supra note 150; see also Francer, supra
note 56, at 278 (stating that the 1990 Deliberate Release Directive was binding on all Member
States as a directive).
668 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
not occur from natural processes.
239
In order to comply with the 1990
Deliberate Release Directive, Member States were required to pass
conforming legislation within eighteen months.
240
The first part of
this Directive was a premarket notification, in which a manufacturer
wishing to place a food containing a GMO into the market was
required to submit a notification to the “competent authority” of the
Member State where the GMO would be released.
241
It required the
manufacturer to include in its notification information that was
necessary to evaluate any immediate or delayed foreseeable risks that
the GMO may have posed to human health or the environment.
242
Thus, while the FDA relies on manufacturers of GMO products to
ensure that their products comply with the agency’s safety standards,
the European Union required that the manufacturer provide the
information necessary for a proper third-party risk assessment.
243
Some of the required notification data included methods used for
modification, allergencity, antibiotic resistance, and potential for
genetic transfer and exchange with other organisms.
244
239. See 1990 Deliberate Release Directive, supra note 150, art. 2, at 2 (defining
“genetically modified organism (GMO)”); Francer, supra note 56, at 279 (detailing the broad
scope of the 1990 Deliberate Release Directive).
240. See 1990 Deliberate Release Directive, supra note 150, art. 23 (setting forth the
time span in which the Member States had to pass legislation in order to conform with the
Directive as eighteen months); Francer, supra note 56, at 279 (stating the eighteen-month
deadline for Member States under the 1990 Deliberate Release Directive).
241. See 1990 Deliberate Release Directive, supra note 150, art. 5, at 1 (mandating the
notification for manufacturers to be submitted to the competent authority of the Member State
where the GMO would be released); Francer, supra note 56, at 280 (introducing the premarket
notification under the 1990 Deliberate Release Directive).
242. See 1990 Deliberate Release Directive, supra note 150, art. 5, at 2(a) (setting forth
the requirements of the notification with respect to risk assessment); Francer, supra note 56, at
279-80 (setting forth the requirements of the notification with respect to risk assessment).
243. See Francer, supra note 56, at 279-80 (describing the independent risk assessment
conducted by the competent authority of the Member State that received the notification); see
also 1990 Deliberate Release Directive, supra note 150, annex II (some of the required
notification data included methods used for modification, allergencity, antibiotic resistance,
and potential for genetic transfer and exchange with other organisms). See generally Terrence
P. Stewart & David S. Johanson, Policy in Flux: The European Union’s Laws on Agricultural
Biotechnology and Their Effects on International Trade, 4
DRAKE J. AGRIC. L. 243 (1999)
(giving an overview of the foundation of the EU regulatory system).
244. See 1990 Deliberate Release Directive, supra note 150, annex II; Francer, supra
note 56, at 280 (discussing the required notification data).
2017] GMO LABELING IN THE US AND EU 669
The second part of this Directive required review by the
competent authority in the Member State.
245
After the competent
authority of a Member State received a GMO notification, it had to
submit a summary of the notification to the European Commission,
which was responsible for immediately giving the summary to the
competent authorities of each Member State.
246
Within ninety days,
the Member State that received the notification from the manufacturer
could either approve or reject the notification.
247
As part of this
review, the competent authority in the Member State was required to
determine if the notification fulfilled the requirements under the 1990
Deliberate Release Directive, while giving particular attention to the
environmental risk assessment.
248
If the competent authority found
that introducing the GMO into the environment was too high of a risk
to human health and the environment, it was allowed to reject the
application for use in the European Union.
249
However, if it found that
the release of the GMO into the environment would be safe to human
health and the environment, it was required to send the dossier of
notification and its recommendation to the Commission and other
Member States.
250
Under the 1990 Deliberate Release Directive, GMO labeling
was not required.
251
While Article 11.1 stated that the notifying party
must include a proposal for labeling or packaging a product approved
for the market, it also clearly indicated that the party could also
choose not to comply with one or more of the labeling rules.
252
245. See 1990 Deliberate Release Directive, supra note 150, art. 5, at 1 (setting forth the
notification procedure); Francer, supra note 56, at 280 (explaining that manufacturers needed
to provide the competent authority in the Member State where the GMO would be released).
246. See 1990 Deliberate Release Directive, supra note 150, art. 9, at 1-2 (requiring the
creation and distribution of the summary).
247. See id. art. 6, at 2 (stating what the Member State that received the notification
could do).
248. See id. art. 12, at 1 (describing what the Member State had to do with respect to the
notification).
249. See id. art. 12 (explaining how a competent authority could reject the application for
use in the European Union).
250. See id.
251. See id. art. 11, at 1 (detailing the procedure for labeling GMOs); Stewart &
Johanson, supra note 243, at 258 (stating that GMO labeling was not mandated under the 1990
Deliberate Release Directive).
252. See 1990 Deliberate Release Directive, supra note 150, art. 11, at 1 (explaining
how applicants could propose not to comply with the labeling requirements in Annex III.B);
670 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
According to the 1990 Deliberate Release Directive, after approval of
a GMO notification, other Member States had sixty days to object to
the GMO being introduced into the environment.
253
If no such
objection was made, then the Member State that reviewed the
notification would give written consent to the use of the GMO.
254
If a
Member State did object within the sixty days and the competent
authorities of the two Member States could not reach an agreement,
the Commission was responsible for deciding whether to consent to
the use of the GMO through a procedure under Article 21.
255
The Commission was then required to draft and submit a
proposal to a Committee made up of representatives from the Member
States for review.
256
If the measures were in accordance with the
opinion of the Committee, then the Commission would adopt the
measures.
257
However, the Commission had to forward the proposal
to the Council if they were not in accordance with the opinion of the
Committee or if the Committee did not give an opinion.
258
The
Council would then vote on the measures, either rejecting them
unanimously or endorsing them by a qualified majority.
259
The
Commission had to adopt the proposed measures if the Council failed
to vote upon the proposal within three months.
260
If the Commission
adopted the proposed measures, then the Member State that initially
received the notification was required to consent to the placing of the
see also Stewart & Johanson, supra note 243, at 258 (explaining the labeling aspects of the
1990 Deliberate Release Directive).
253. See 1990 Deliberate Release Directive, supra note 150, art. 13, at 2 (giving
instructions if no Member States objected within sixty days).
254. See id. (explaining how written consent was given if no Member States objected);
Francer, supra note 56, at 280-81 (explaining the procedure if no Member States objected
within sixty days).
255. See 1990 Deliberate Release Directive, supra note 150, art. 13, at 3 (explaining the
role of the Commission in this situation); see also Stewart & Johanson, supra note 243
(describing the protocol under the Directive when the competent authorities of two Member
States could not come to an agreement).
256. See 1990 Deliberate Release Directive, supra note 150, art. 21 (describing the
responsibility of the Commission).
257. See id. (setting forth the action to be taken if the measures were in accordance with
the opinion of the Committee).
258. See id. (explaining what the Commission was required to do in this situation).
259. See id. (putting forward the voting requirements).
260. See id. (describing what the Commission would do if the Council did not vote
within three months).
2017] GMO LABELING IN THE US AND EU 671
GMO onto the market in writing and to notify other Member States of
its consent.
261
After the initial Member State consented to the
marketing of the GMO, it may have been used in the European Union
without any further notification required and Member States could not
“restrict or impede” the placing on the market of products containing
or consisting of GMOs that comply with the 1990 Deliberate Release
Directive.
262
While Member States could not prevent an approved GMO from
being placed on the market, Article 16 of the Directive provided an
important exception to this rule that proved to be a problem in
1997.
263
Even if a product has been approved for the market under the
1990 Deliberate Release Directive, a Member State could
provisionally restrict the product from its borders if it had justifiable
reasons to believe that the GMO posed risks to human health or the
environment.
264
If a Member State chose to restrict the product under
Article 16, it was required to notify the Commission and the other
Member States.
265
Within three months, the Commission was required
to make a decision concerning the State’s action under procedures set
out in Article 21.
266
This created a significant loophole for the
Member States to restrict approved GMOs in their territories.
267
This
proved to be a significant international problem in 1998, when a de
facto moratorium on GMOs occurred in the European Union and
significant reform was undertaken that resulted in the current GMO
regulatory system of the European Union.
268
261. See id. art. 20 (explaining the notification process once the Commission adopted the
proposed measures).
262. See id. (detailing the conditions of the use of the approved GMO).
263. See id. art. 16, at 1 (providing the Safeguard Clause of the Directive).
264. Id. (explaining under what conditions a Member State could restrict an approved
GMO from its territory).
265. Id.
266. See id. art. 16, at 2 (giving the procedures for the Commission to follow).
267. See Mereu, supra note 182, at 206 (explaining how several Member States relied on
the Safeguard Clause under Article 16 in order to refuse the implementation of the
authorization of a particular GMO); MacKenzie & Franceson, supra note 236, at 538-39
(detailing Article 16 and how it was used by several Member States in 1997).
268. See Stewart & Johanson, supra note 243, at 261-62 (discussing the crisis in the
European Union when certain Member States used this loophole to ban approved Bt-maize
from their territories in 1997); Mereu, supra note 182, at 206 (explaining this part of the 1990
Deliberate Release Directive).
672 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
In the years following the 1990 Deliberate Release Directive, the
Commission indicated that the European Union was lagging in
biotechnology advancements and progress in the 1992 White Paper
on Growth, Competiveness, and Employment and the 1994
Communication on Biotechnology.
269
In 1996, a review conducted by
the Commission called for reform to the EU regulatory system,
including more streamlined approval procedures for GMOs that posed
a lower or nonexistent risk and a possible reform to the labeling
requirements under the 1990 Deliberate Release Directive.
270
In 1996,
the President of the Commission expressed concerns over a lack of
competition in the European Union and the trend of European
companies that were seeking to invest in places outside of the
European Union.
271
In fact, much of these remarks included
comparisons of the European Union to the United States and concerns
over the United States’ advantage in the field of biotechnology.
272
In 1997, France sent a favorable opinion on the approval of a
GMO product named Bt-maize to the Commission, which then
received objections from Austria, Belgium, Germany, Denmark, Italy,
and Sweden after it forwarded the notification to the other Member
269. See Stewart & Johanson, supra note 243, at 263-64 (analyzing the viewpoint of the
Commission that greatly contrasted public opinion at the time concerning the need for more
involvement in the advancement of biotechnology); see also D
AVID BISSONNETTE, IT’S ALL
ABOUT
NUTRITION: SAVING THE HEALTH OF AMERICANS 162 (2013) (explaining the hostile
public opinion towards genetic engineering during 1997); MacKenzie & Francescon, supra
note 236, at 530-31 (discussing the unpopular views of the Commission that biotechnology
was a key for future competitive development and the expressed concern of the Commission
regarding the European Union’s lack of involvement in the field).
270. See Commission Press Release, IP 96/1148 (Dec. 10, 1996); Stewart & Johanson,
supra note 243, at 263-64 (discussing the Commission’s position on the EU GMO regulatory
system in 1996).
271. See Stewart & Johanson, supra note 243, at 264 (quoting the President of the
Commission’s statement concerning the position of the European Union in the biotechnology
sector and the trend of European companies investing outside of the European Union). See
generally MacKenzie & Francescon, supra note 236, at 530-31 (discussing the general
concerns about the negative impacts of EU avoidance of biotechnology).
272. See Stewart & Johanson, supra note 243, at 264-65 (describing some of the
comparisons made with respect to biotechnology). See generally MacKenzie & Francescon,
supra note 236, at 530-31 (highlighting the concerns of the Commission that involvement in
biotechnology would determine if Community industries would remain world leaders in
developing products that were innovative).
2017] GMO LABELING IN THE US AND EU 673
States.
273
Under the 1990 Deliberate Release Directive, the
Commission sought the opinion of the Regulatory Committee on the
Commission’s draft decision, which wanted consent to put the
product on the market for all uses.
274
Many Member States that
opposed the drafted proposal were concerned with the fact that the
proposal did not include labeling the product as a GMO.
275
They were
also worried about the long-term environmental risks that the GMO
product might cause.
276
After the Regulatory Committee did not
approve the draft decision due to the lack of a qualified majority, it
sent a proposal to the Council under Article 21 of the 1990 Deliberate
Release Directive for it to decide whether the GMO maize would be
allowed on the market.
277
According to this proposal, no label would
be required if the GMO was not a threat to humans or the
environment.
278
273. See Stewart & Johanson, supra note 243, at 260-61 (explaining the favorable
opinion sent by France to the Commission and listing the Member States who had objected to
the proposal). See generally Association Greenpeace France and Others v. Ministère de
l’Agriculture et de la Pêche and Others, Case C-9/99 [2000] E.C.R. I-1676 (providing a
summary of these developments); Commission Decision No. 97/98/EC (Zea mays L.), 1997
O.J. L 31/69 (giving a history).
274. See Stewart & Johanson, supra note 243, at 261 (detailing how the Commission
sought the opinion of the Regulatory Committee); E
XPLORING CENTRAL AND EASTERN
EUROPE’S BIOTECHNOLOGY LANDSCAPE 189 (Peter T. Robbins & Farah Huzair eds., 2011)
(discussing this Committee and its role).
275. See Stewart & Johanson, supra note 243, at 261-62 (explaining the expressed
concerns of the Member States); M
ARIA LEE, EU REGULATION OF GMOS: LAW AND
DECISION MAKING FOR A NEW TECHNOLOGY 2 (Han Somsen ed., 2008) (discussing these
attitudes).
276. See Stewart & Johanson, supra note 243, at 261-62 (detailing the environmental
concerns of several Member States); Lee, supra note 275, at 2 (highlighting the Member
States’ arguments concerning the environment).
277. See Stewart & Johanson, supra note 243 (detailing the actions of the Commission);
E
XPLORING CENTRAL AND EASTERN EUROPE’S BIOTECHNOLOGY LANDSCAPE, supra note
274, at 189 (explaining that after the Article 21 committee of representatives of the Member
States failed to reach a majority opinion, the Commission took the decision to the European
Environment Council).
278. See Stewart & Johanson, supra note 243 (describing the proposal); E
XPLORING
CENTRAL AND EASTERN EUROPE’S BIOTECHNOLOGY LANDSCAPE, supra note 274, at 189
(explaining that after the Article 21 committee of representatives of the Member States failed
to reach a majority opinion, the Commission took the decision to the European Environment
Council).
674 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
Before the three-month deadline ended, Austria brought new
information concerning the safety of the Bt-maize.
279
A month before
the deadline, the Commission decided to have three scientific
committees review the new information.
280
Upon review, all three
committees gave favorable opinions concerning the proposal that
denied the presence of risk to humans, the environment, or animals.
281
After the favorable opinions were released, the Commission adopted
Commission Decision 97/98/EC and France was allowed to place the
GMO on the market without requiring labeling of the product as
genetically modified.
282
The beginning of this movement towards further approval of
GMOs was not accepted well by the public in 1997, as public
opposition to GMOs remained significantly high.
283
Additionally, not
all bodies of the European Union were in agreement with the approval
decision, as the Parliament issued a resolution that heavily opposed
the Commission for not considering new scientific evidence on the
risks posed by the GMO and for acting in the face of disapproval of
most Member States and the Parliament.
284
Specifically, the
Parliament demanded that the authorization procedure be reopened
and that the procedures to authorize GMOs be revised in order to
279. See Commission Press Release, IP/98/358 (Apr. 16, 1998) (discussing the
information submitted by Austria concerning the safety of this GMO); Stewart & Johanson,
supra note 243 (explaining Austria’s actions).
280. See Commission Press Release, IP/98/358 (Apr. 16, 1998) (explaining how the
Commission responded to the actions of Austria by requesting the opinion of the three
Scientific Committees); Stewart & Johanson, supra note 243 (detailing this development).
281. See Stewart & Johanson, supra note 243 (discussing the opinions regarding the
proposal); Zea mays L., 1997 O.J. 31/69 (explaining the conclusions of the Commission that
there was no reason to believe that the maize would adversely affect human health or the
environment).
282. See Stewart & Johanson, supra note 243, at 263 (discussing the approval of the Bt-
maize in 1997); T
HE YEAR IN TRADE (1997): OPERATION OF THE TRADE AGREEMENTS
PROGRAM, 49TH REPORT 104 (Arona Butcher ed., 1997) (stating that in 1996, the Commission
authorized the sale of a particular strain of corn that was genetically modified).
283. See Stewart & Johanson, supra note 243, at 263-71 (discussing the contentious
response to the Commission’s actions and the belief that the European Union should take a
larger role in the advancement of biotechnology); see also B
ISSONNETTE, supra note 269, at
162 (stating that during 1997, there was an uneasiness among Europeans and that public
opinion in the European Union rose against GM crops with protests becoming more common).
284. See Stewart & Johanson, supra note 243, at 265-66 (detailing the Parliament’s
scathing reaction to the Commission); Lee, supra note 275, at 2 (stating that the Commission
authorized the product despite a European Parliament resolution against authorization).
2017] GMO LABELING IN THE US AND EU 675
mirror the clear opinions of the Member States and the Parliament.
285
Instead of responding to the Parliament’s resolution, the
Commission’s spokesman dismissed the thought of suspending the
Bt-maize from the market unless new scientific evidence was
presented on the product’s dangers and stated that the Parliament’s
resolution was based on factual errors.
286
Because Member States were allowed to object to the placement
of approved GMOs on the market under the 1990 Deliberate Release
Directive, a crisis erupted when several Member States refused to
implement the authorization.
287
Under Article 16 of the Directive,
Austria issued a decree that prohibited the marketing of Bt-maize in
its borders because it believed research that showed that an antibiotic-
resistant gene named ampicillin could be passed to animals and
humans through the Bt-maize.
288
Citing the same reasons,
Luxembourg also banned the GMO product shortly after.
289
In an
attempt to solve this issue, the Commission proposed a “fast-track”
procedure to require labeling by amending the 1990 Deliberate
Release Directive. The 1997 Adapting Directive altered Annex III of
the 1990 Deliberate Release Directive to require labeling of products
that contained GMOs.
290
The Directive also stated that if GMO
285. See Stewart & Johanson, supra note 243, at 265-66 (quoting the Parliament’s
resolution); Lee, supra note 275, at 2 (summarizing the reaction of the Parliament).
286. See Stewart & Johanson, supra note 243, at 266 (explaining how the Commission
did not change its trajectory in response to the Parliament’s resolution). See generally Lee,
supra note 275, at 2 (describing how the Commission continued with the authorization despite
the Parliament resolution against authorization).
287. See Stewart & Johanson, supra note 243, at 266 (analyzing the response of several
Member States to prohibit the marketing of Bt-maize in their territories); T
HE YEAR IN TRADE,
supra note 282 (explaining how Austria, France, Italy, and Luxembourg announced bans on
the planting and use of genetically modified corn and how some Member States eventually
lifted their bans in the fall of 1997).
288. See Stewart & Johanson, supra note 243, at 266 (outlining Austria’s response to the
authorization of Bt-maize); T
HE YEAR IN TRADE, supra note 282, at 104 n.180 (stating that
Austria banned Bt-maize after it was authorized).
289. See Stewart & Johanson, supra note 243, at 267 (explaining how Luxembourg
similarly reacted to the approval of Bt-maize); T
HE YEAR IN TRADE, supra note 282, at 104
n.180 (stating that Luxembourg was one of the Member States that banned Bt-maize).
290. See Commission Directive 97/35/EC Adapting to Technical Progress For the
Second Time Council Directive 90/220/EEC On The Deliberate Release Into The Environment
Of Genetically Modified Organisms, 1997 O.J. L 169/72 (hereinafter 1997 Adapting
Directive); Stewart & Johanson, supra note 243, at 270-71 (describing the adoption and
content of the 1997 Adapting Directive).
676 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
products placed in the market were mixed with non-GMO products, it
was sufficient to state the possibility that GMOs may be present in
such products.
291
Despite attempts to change the authorization procedure, a de
facto moratorium occurred in the European Union, as no new GMOs
were authorized in the European Union and no new GMOs were
placed on the market until 2004.
292
When the United States, Canada,
and Argentina brought cases against the European Union in the World
Trade Organization (“WTO”), the WTO panel declared that the
European Union unacceptably delayed processing GMO applications
by the members and that the moratorium could not continue because
it conflicted with the European Union’s international commitments.
293
In the midst of these upheavals, the European Union formed the three-
part GMO regulatory system still used today, made up of the 2001
Deliberate Release Directive, the Genetically Modified Food and
Feed Regulation, and the Traceability and Labeling Regulation.
294
291. See 1997 Adapting Directive, supra note 290, Annex III(C) (explaining how to deal
with this possible mix); Stewart & Johanson, supra note 243, at 269-70 (explaining the
requirements under the 1997 Adapting Directive).
292. See B
ALANCING BETWEEN TRADE AND RISK 109 (Marjolrin B.A. van Asslet,
Esther Versluis, & Ellen Vos eds., 2013) (explaining how the Member States suspended all
authorizations of GMOs and imposed a de facto moratorium “. . . until the framework could be
reformed in such a way as to apply stricter rules, in particular on the labeling and traceability
of GMOs”); Mereu, supra note 182, at 207 (explaining how the de facto moratorium ensued in
1998, leading there to be no new GMOs placed on the market again until 2004).
293. See generally Panel Report, European Communities–Measures Affecting the
Approval and Marketing of Biotech Products, WTO Doc. WT/DS291/R (adopted Sept. 9,
2006); Meureu, supra note 143, at 206-07 (detailing how the WTO found that the de facto
moratorium was not compatible with the international commitments of the European Union);
Andrea L. Stephenson, Germany’s Ban Of Monsanto’s Genetically Modified Maize
(MON810): A Violation Of International Law, 2 T
RADE L. & DEV. 292, 300 (2010) (analyzing
how the WTO dispute panel decided that the European Union breached its legal obligations
under the WTO with its unacceptable delay of processing GMO applications by the Members).
294. See David E. Sella-Villa, Gently Modified Operations: How Environmental
Concerns Addressed Through Customs Procedures Can Successfully Resolve the US-EU GMO
Dispute, 33
WM. & MARY ENV’T L. & POL’Y REV. 971, 982-83 (2008-2009) (summarizing the
current regulatory system in the European Union made up of these measures); Carrau, supra
note 21, at 1185-86 (outlining the European Union’s GMO regulatory system).
2017] GMO LABELING IN THE US AND EU 677
7. The 2001 Deliberate Release Directive
After realizing many problems associated with the 1990
Deliberate Release Directive, the European Parliament and the
Council of the European Union repealed it and replaced it with the
2001 Deliberate Release Directive.
295
This Directive applies to all
attempts to grow or sell GMOs in the European Union, except those
with a strict scientific purpose, and thus covers placing GMO
products or products containing GMOs on the market within the
European Union.
296
The precautionary principle is heavily
emphasized throughout the document.
297
The Directive states that in order to protect human health and
environmental demands, a state regulatory agency must control risks
that may come from deliberately releasing GMOs into the
environment, especially because their effects may irreversibly and
adversely affect the environment of neighboring Member States.
298
In
Article 1, the Directive states that in accordance with the
precautionary principle, the objective of the Directive is to
approximate the laws and regulations of the Member States and to
protect human health and the environment.
299
Prior to a deliberate
release of a GMO into the environment, a “case-by-case”
environmental risk assessment must always be conducted that
considers the potential cumulative long-term effects of the interaction
of the GMO with the environment.
300
More importantly, this
environmental risk assessment is to be made based on independent
295. See generally 2001 Deliberate Release Directive, supra note 151; Fernandez, supra
note 181, at 339 (stating that the 1990 Deliberate Release Directive was amended in 2001 and
renamed Directive 2001/18/EC).
296. See 2001 Deliberate Release Directive, supra note 151, art. 2, at 4 (defining
“placing on the market” and listing the three operations that were not to be regarded as
“placing on the market”); Sella-Villa, supra note 294, at 986 (explaining the scope of the 2001
Deliberate Release Directive).
297. See 2001 Deliberate Release Directive, supra note 151, recital 8 (stating that the
precautionary principle was taken into account when the Directive was being drafted and must
be taken into account when implementing it).
298. See id. recital 4 (noting the possibly irreversible effects of GMOs).
299. See id. art. 1 (detailing the objective of the Directive).
300. See id. art. 19 (setting out the idea that a case-by-case environmental risk
assessment should always be carried out before a release and how this assessment should
appropriately consider the potential cumulative long-term effects associated with the
interactions with other GMOs and the environment).
678 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
scientific advice through a common methodology, rather than the
patchwork system consisting of independent Member State actions
that had been created under the 1990 Deliberate Release Directive.
301
Part B of this Directive applies to the deliberate release of
GMOs for any other purpose than for placing on the market, while
Part C covers the placing on the market of GMOs as or in products.
302
Because this Directive applies to both the release and the placing on
the market of products containing GMOs, this Directive applies to
both the farming of GMOs and the importation of such products.
303
Furthermore, independent researchers should be given access to all
relevant material when the Commission is considering a GMO for
approval.
304
The Directive also indicates that a step-by-step system
must be applied to the GMO approval process, in which a specific
GMO becomes systematically less contained when evaluations show
that its release does not threaten human health and the environment.
305
Furthermore, the Directive asserts that every GMO being considered
for placement on the market must have undergone satisfactory field
testing in the ecosystems that could be affected by its release.
306
For
purposes of this Note, Part C will be discussed to demonstrate the
approval process for GMOs for the purpose of placing them on the
market.
307
While the Directive does not apply to organisms that have been
obtained through certain GE techniques that have conventionally been
used and have a long safety record, it does set out a very specific
301. See id. recital 20 (describing the necessity of having a common methodology for the
environmental risk assessment, which is based on independent scientific advice).
302. See id. Parts B-C; Margaret Rosso Grossman, Traceability and Labeling Of
Genetically Modified Crops, Food, and Feed In The European Union, 1 J.
FOOD L. & POL’Y
43, 56 (2005) (explaining what is governed by Parts B and C of the 2001 Deliberate Release
Directive).
303. See 2001 Deliberate Release Directive, supra note 151, art. 1 (describing how the
Directive applies to both).
304. See id. (stating that while the Commission is considering a GMO for approval,
independent researchers should have access to all relevant material).
305. Id. recital 24 (detailing the step-by-step process).
306. Id. recital 25 (describing how no GMOs may be considered for placing on the
market without having gone through a satisfactory field testing at the stage of research and
development in ecosystems that can be affected by their use).
307. See infra notes 308-21 and accompanying text (detailing Part C of the 2001
Deliberate Release Directive).
2017] GMO LABELING IN THE US AND EU 679
procedure for approving all remaining GMOs.
308
As part of this case-
by-case analysis, an applicant wishing to place a GMO on the market
must first submit a notification to the national competent authority
that contains a technical dossier of information that includes a full
environmental risk assessment and appropriate safety and emergency
responses.
309
As part of this assessment, applicants are required to
evaluate potential risks to human health and the environment
associated with the release of the GMOs in question.
310
The
assessment is broad, as it applies to risks that are direct or indirect and
immediate or delayed.
311
Applicants are required to include in their
application a plan for monitoring the effects and impact of the GMO
release under Article 13.
312
After the applicant submits the application to the competent
authority in a Member State, the authority evaluates the notification
for compliance with the Directive and then makes an independent
assessment.
313
Within sixty days from the date of the circulation of
the assessment report, a competent authority or the Commission may
make comments, present reasoned objections to the placing on the
market of the GMO, and ask for further information.
314
The Member
State’s competent authority that received the notification can either
reject the application or approve the GMO for entry into the
308. See 2001 Deliberate Release Directive, supra note 151, recital 17 (excluding
organisms that have been obtained through certain genetic modification techniques that have
been conventionally used in a number of applications and that have a long safety record from
the Directive).
309. Id. recitals 32-33 (stating the requirements under the Directive for the notification);
id. art. 13 (setting forth the specific procedure for this notification).
310. Id. art. 2, at 8 (defining “environmental risk assessment” and what is required to be
addressed under this evaluation).
311. Id.; Paula Rey Garcia, Directive 2001/18/EC on the Deliberate Release into the
Environment of GMOs: An Overview and the Main Provisions for Placing on the Market, 3 J.
EUR. ENV’T & PLAN. L. 3, 8 (2006) (explaining the types of risks to be examined during this
analysis).
312. See 2001 Deliberate Release Directive, supra note 151, art. 13, at 2(e) (stating the
requirement that applicants include a plan for monitoring the effects and impact of the GMO
release).
313. See id. art. 14 (detailing the process for the competent authority once it receives the
application).
314. Id. art. 15, at 1 (describing the ability of competent authorities to submit comments
or reasoned objections, which are circulated to all competent authorities by the Commission).
680 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
market.
315
Under Article 15, if the competent authority approves the
GMO and there is no reasoned objection from another Member State
or the Commission within sixty days of the date of circulation of the
assessment report or if outstanding issues are resolved within the 105
day period referred to in Paragraph 1, the competent authority is
required to give written consent and transmit it to the applicant, the
Member States, and the Commission within thirty days.
316
This
approval for the introduction into the EU market lasts for ten years,
starting on the date the consent was given.
317
The Directive also gives
specific procedures for the renewal of consent, which include the
applicant filing an abbreviated notice packet to the competent
authority of the Member State.
318
The competent authority has to
complete another assessment of the GMO to determine if it should
remain on the market and must consider the well-reasoned objections
from other Member States and the Commission.
319
Perhaps the most
important part of this segment of the Directive is the Safeguard
Provisions, under which any Member State can ban a GMO in its
territory.
320
A Member State can only act under this provision if it has
new or additional scientific knowledge with detailed grounds for
believing that an approved GMO constitutes a risk to human health or
the environment.
321
8. The Genetically Modified Food and Feed Regulation
Under the “one door, one key” principle, applicants can a file a
single application to be authorized for placement on the market as a
food or feed under the Genetically Modified Food and Feed
315. See id. art. 15, at 2-3 (stating that if the competent authority decides that the GMO
should not be placed on the market, the notification shall be rejected, and giving the procedure
for approval by the Member State’s competent authority).
316. See id. art. 15, at 3 (providing instructions for the competent authority which has
approved a GMO and has not received a reasoned objection from other Member States or the
Commission within sixty days after the date of circulation of the assessment report referred to
in Article 14).
317. See id. art. 15, at 4 (establishing the ten-year limit on the authorization of a GMO).
318. See id. art. 17 (detailing the procedure for renewal of consent).
319. See id. (stating these requirements under the renewal procedure).
320. See id. art. 23 (providing the Safeguard Clause, which allows Member States to
refuse to allow future circulation of a GMO in their borders).
321. See id. at 1 (detailing the only way a Member State can invoke the Safeguard
Clause).
2017] GMO LABELING IN THE US AND EU 681
Regulation and for release into the environment under the 2001
Deliberate Release Directive.
322
Relying on the principles of the 2001
Deliberate Release Directive, the Genetically Modified Food and
Feed Regulation further refined the application process.
323
Under
Article 3, these requirements apply to (a) GMOs for food use, (b)
food containing or consisting of GMOs, and (c) food produced from
or containing ingredients produced from GMOs.
324
According to Article 4 of the Genetically Modified Food and
Feed Regulation, no person can place any of the products described in
Article 3 on the market unless the specific product has been
authorized under the Section and the relevant conditions of the
authorization are satisfied.
325
While applicants are still required to
submit detailed applications to the competent Member State authority,
this authority is now required to work with other Member States and
the European Food Safety Authority (“EFSA”), a body established by
the General Principles and Requirements of Food Law Regulation.
326
The Member State that has received an application forwards it to the
EFSA.
327
This specialized body reviews each application and sends
322. While the Genetically Modified Food and Feed Regulation applies to both food and
foodstuffs, this Note will only be addressing the food authorization requirements governed by
Chapter II of the Regulation. See Bernd van der Meulen, The EU Regulatory Approach to GM
Foods, 16 K
AN. J.L. & PUB. POL’Y 286, 307 (2007) (stating that under the “one door one key”
principle, a single application can be filed to obtain authorization under the 2001 Deliberate
Release Directive for release into the environment and authorization for placement on the
market as a food or feed under the Genetically Modified Food and Feed Regulation); Garcia,
supra note 311, at 11 (explaining how these applications can be filed under either the 2001
Deliberate Release Directive and the Genetically Modified Food and Feed Regulation).
323. See Genetically Modified Food and Feed Regulation, supra note 151, recital 9
(stating that the new authorization procedures for genetically modified food and feed should
include the principles introduced in the 2001 Deliberate Release Directive); Grossman, supra
note 295, at 61 (explaining how the Genetically Modified Food and Feed Regulation
incorporates the principles introduced in the 2001 Deliberate Release Directive).
324. See Genetically Modified Food and Feed Regulation, supra note 151, art. 3, at 1
(explaining what the Section applies to).
325. See id. art. 4, at 2 (setting forth this requirement).
326. See id. arts. 3-7 (highlighting the more significant part of the ESFA in the
regulation of GMOs); Sella-Villa, supra note 294, at 988 (discussing the increased role of the
EFSA in the EU regulatory system).
327. See Genetically Modified Food and Feed Regulation, supra note 151, art. 5, at 2
(setting forth the requirements for the competent authority that receives an application under
this Regulation).
682 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
the dossier to the other Member States, which are allowed to make
their own evaluations and give their opinions to the EFSA.
328
It is important to note that the EFSA is not a regulatory authority
with its own powers, but rather serves as an “independent source of
advice.”
329
As a specialized body, the EFSA is required to make a
scientific risk assessment that addresses both environmental risks and
risks to human and animal health safety, which it can do itself or
assign to a national food assessment body.
330
According to the
Regulation, the EFSA is also required to submit the elements
necessary to test and validate the method of detection and
identification of the GMO proposed by the applicant to the
Community Reference Laboratory, which is aided by the European
Network of GMO laboratories.
331
The Community Reference
Laboratory is responsible for validating the applicant’s methods for
detecting and identifying the transformation event in the GMO food,
as well as the applicant’s data concerning sampling and detection.
332
After receiving a full evaluation report from the Community
Reference Laboratory, the EFSA publishes the opinion to the public
within six months of receiving the original application from the
Member State and sends this opinion to the Commission.
333
At this
time, the public is also allowed to submit opinions to the EFSA on the
328. See id. art. 4, at 2(b) (charging the ESFA with the responsibility of informing the
Commission and the other Member States about the application).
329. See Vesco Paskalev, Can Science Tame Politics: The Collapse of the New GMO
Regime in the EU, 3
EUR. J. RISK REG. 190, 193 (2012) (detailing the function of the ESFA);
van der Meulen, supra note 322, at 301 (explaining how the EFSA is an independent entity
that provides scientific advice and technical support for the Community’s legislation and
policies).
330. See Genetically Modified Food and Feed Regulation, supra note 151, art. 6, at 3(b)
(stating that the EFSA may ask the appropriate food assessment body of a Member State to
carry out a food safety assessment); van der Meulen, supra note 322, at 308 (detailing the
responsibilities of the EFSA with respect to human health and the environment).
331. See Genetically Modified Food and Feed Regulation, supra note 151, art. 6, at 3(d)
(stating what the EFSA must submit to the Community Reference Laboratory).
332. See id. art. 6, at 3(d) (explaining that the Community Reference Laboratory must
test and validate the method of detection and identification that the applicant has proposed);
see also van der Meulen, supra note 322, at 308 (describing the role of the Community
Reference Laboratory).
333. See Genetically Modified Food and Feed Regulation, supra note 151, art. 6, at 7
(giving the requirements for the opinion of the ESFA); van der Meulen, supra note 322, at
308-09 (giving the procedure that the ESFA must undergo once it has received an evaluation
report from the Community Reference Laboratory).
2017] GMO LABELING IN THE US AND EU 683
pending GMO application within thirty days from the publication.
334
The opinion must include a scientific assessment conducted by a
committee of independent scientific experts that checks and evaluates
data from the safety research that the applicant has presented.
335
Within three months of receiving the EFSA’s opinion, the
Commission must draft and submit a proposal for granting or refusing
authorization to the Standing Committee on the Food Chain and
Animal Health, which is comprised of representatives of the Member
States.
336
These representatives have expertise in areas including
GMOs, food supply safety, and animal health, and are nominated by
Member States.
337
If the decision is different from the EFSA’s
opinion, it must explain the difference in detail.
338
If the Committee
approves the proposal by a qualified majority, then the Commission
adopts the Decision.
339
If the Committee does not give a favorable
334. See Genetically Modified Food and Feed Regulation, supra note 151, art. 6, at 7
(explaining the public’s opportunity to submit opinions); C
AOIMHIN MACMAOLAIN, EU FOOD
LAW 248 (2007) (providing the specific requirements concerning the publication of the
EFSA’s opinion and the public’s opportunity to respond).
335. See Genetically Modified Food and Feed Regulation, supra note 151, art. 6, at 7
(requiring the ESFA to make its opinion public and allowing the public to make comments
within thirty days); van der Meulen, supra note 322, 308-09 (discussing this requirement);
M
ACMAOLAIN, supra note 334, at 249 (stating that the ESFA must give an opinion on the
merits of the application within six months of receiving it).
336. See Genetically Modified Food and Feed Regulation, supra note 151, art. 7, at 1
(requiring the Commission to submit a proposal for granting or refusing authorization to the
Standing Committee on the Food Chain and Animal Health within three months of receiving
the EFSA’s opinion); see also van der Meulen, supra note 322, at 309 (explaining what the
Commission must do in response to the EFSA’s opinion and describing the makeup of the
Standing Committee on the Food Chain and Animal Health).
337. See General Principles and Requirements of Food Law Regulation, supra note 177,
art. 58, at 1 (describing and establishing the Standing Committee on the Food Chain and
Animal Health); Sella-Villa, supra note 294, at 988 (describing the expertise and nomination
of those on the Standing Committee on the Food Chain and Animal Health).
338. The Commission’s decision must be based on the opinion of the Authority, relevant
provisions of Community Law, and any other relevant factors. See Genetically Modified Food
and Feed Regulation, supra note 151, art. 7, at 1 (stating that the Commission must explain
any differences when the draft decision is not in accordance with the opinion of the ESFA);
M
ACMAOLAIN, supra note 334, at 249 (explaining how the Commission must note any
differences when its decision diverges from the ESFA’s opinion).
339. See Genetically Modified Food and Feed Regulation, supra note 151, art. 35
(describing the Committee Procedure); van der Meulen, supra note 322, at 309 (describing
how the Commission adopts the Decision if the Committee approves the proposal by a
qualified majority).
684 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
opinion, the draft Decision is then sent to the Council of Ministers,
who can adopt or reject it by a qualified majority.
340
Finally, the
Commission must adopt the decision if the Council fails to act within
three months.
341
If a GM food is authorized, the decision is addressed to the
applicant and therefore only the applicant is permitted to bring it into
the market in any and all of the Member States.
342
The market
authorization of a GM food is valid for ten years throughout the
European Union.
343
Specific details about the decision are published
in the Official Journal of the European Union and the product is
entered into a public register of GM food and feed.
344
9. The Labeling of GMOs in the European Union Under the
Traceability and Labeling Regulation
In sharp contrast to the previous labeling system under the FDA
Statement of Policy, the European Union requires that Member States
take steps to ensure traceability and labeling of authorized GMOs at
all stages of their placing on the market under the 2001 Deliberate
Release Directive.
345
According to the Traceability and Labeling
Regulation, which serves as the foundation of the current EU GMO
labeling system, traceability requirements for GMOs should facilitate
the withdrawal of products whose unforeseen adverse effects on
340. See van der Meulen, supra note 322, at 309 (explaining how the Council of
Ministers can either adopt or reject the draft Decision by a qualified majority if the Committee
has not given a favorable opinion); see also Genetically Modified Food and Feed Regulation,
supra note 151, art. 7 (giving instructions for this process).
341. See van der Meulen, supra note 322, at 309 (stating that if the Council does not act
within three months, the Commission must adopt the decision); see also Genetically Modified
Food and Feed Regulation, supra note 151, art. 7 (setting the parameters of this process).
342. See generally Genetically Modified Food and Feed Regulation, supra note 151, art.
7, at 1-5 (detailing the procedure once a GMO is authorized); van der Meulen, supra note 322,
at 309 (outlining the process after a GMO is approved in relation to the applicant).
343. See Genetically Modified Food and Feed Regulation, supra note 151, art. 7, at 5
(limiting the approval of a GMO to ten years).
344. See van der Meulen, supra note 322, at 309 (detailing the notification process); see
also M
ACMAOLAIN, supra note 334, at 249 (explaining how applicants are notified).
345. Traceability and Labeling Regulation, supra note 151, recital 1 (detailing the
requirements with respect to traceability of authorized GMOs).
2017] GMO LABELING IN THE US AND EU 685
human health, the environment, or animal health become apparent.
346
More importantly, the Regulation states that traceability should also
facilitate the implementation of risk management measures in
accordance with the precautionary principle.
347
The Regulation also
puts emphasis on consumers, as it states that traceability requirements
for food produced from GMOs are implemented to ensure that
accurate information is available to operators and consumers to
enable them to use their freedom of choice in an effective manner.
348
It further states that it is necessary to ensure that consumers are
completely and reliably informed about GMOs.
349
In the Traceability and Labeling Regulation, the Parliament and
the Council of the European Union set a GMO threshold “de
minimis” amount of 0.9% of the ingredients, which gives some
leniency to manufacturers and producers for certain traces of GMOs
that may be technically unavoidable.
350
If an operator wishes to place
a product on the market that contains an amount of GMOs over the
threshold of 0.9%, he or she is required to indicate in writing (1) each
food ingredient that is produced with GMOs, (2) each of the feed
materials or additives that are produced from GMOs, and (3) that the
product is produced from GMOs on products where there is no list of
ingredients.
351
10. Comparison of GMO Regulation Between the United States and
the European Union
As demonstrated throughout Part I of this Note, the US and EU
GMO regulatory systems differ greatly.
352
The source of the
346. Id. recital 3 (explaining how the traceability requirements under the Traceability
and Labeling Regulation should improve the removal of such products from the market).
347. Id. (emphasizing the continuing importance of the precautionary principle in EU
regulation of GMOs).
348. Id. at 4 (highlighting the European Union’s recognition of consumers’ ability to
freely choose what they consume and the important role that traceability and labeling
requirements play in this ability).
349. Id. art. 1, at 11 (emphasizing the importance of informed consumer choice).
350. Id. art. 1, at 10 (setting forth the threshold level that triggers the requirements of
GMO labeling under this regulation).
351. See id. art. 5, at 1 (describing the requirements for operators who want to sell
products containing GMO levels over the threshold in the European Union).
352. See generally supra Part I (discussing the regulatory systems of both).
686 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
difference is the opposite nature of these systems, namely the United
States’ substantial equivalence doctrine and the European Union’s
precautionary principle.
353
Because the FDA views GMOs as GRAS,
it does not require that companies submit specific information
concerning the safety of their GMO products, as the European Union
does.
354
While the FDA does not conduct independent research for
each GMO seeking approval, the European Union requires an
independent body to do its own research for each application.
355
And
finally, since the FDA presumes GMOs are safe under the substantial
equivalence doctrine, it has not required any labeling of GMOs, as it
does not consider GMOs to be materially different from their
traditional counterparts.
356
In contrast, the European Union requires
traceability at every step for approved GMOs under the precautionary
principle, as future risks may become visible at some point.
357
II. THE PRESSURE FOR MANDATORY GMO LABELING
MEASURES IN THE UNITED STATES AND THE EUROPEAN
UNION
This Part will introduce the current status of the GMO labeling
debate in the United States and will examine a similar debate that
occurred in the European Union that led to a crisis in 1997. Section
II.A explains the now preempted GMO labeling laws of Connecticut,
Maine, and Vermont and compares the requirements of each. Section
II.A also discusses the response to these state labeling laws, including
legal action against the state of Vermont and the US House of
Representatives’ opposition to the laws through H.R. 1599. Finally,
Section II.A also examines the federal compromise of S. 764, which
353. See generally supra Part I (showing how the substantial equivalence doctrine serves
as the basis of the US GMO regulatory system, while the precautionary principle is the
foundation of the EU GMO regulatory system).
354. See generally supra Part I (explaining the contrasting requirements of the US and
EU GMO regulatory systems).
355. See generally supra Part I (providing an overview of the different application
procedures for the United States and the European Union).
356. See generally supra Section I.A (discussing the view of the FDA under the 1992
FDA Statement of Policy and the Coordinated Framework).
357. See generally supra Section I.B.10 (discussing the traceability requirements and
their justifications).
2017] GMO LABELING IN THE US AND EU 687
established national GMO labeling requirements in the United States
and preempted the state GMO labeling laws. Section II.B details how
the European Union faced similar opposition from its public over the
lack of mandatory GMO labeling requirements in 1997 and how it
resolved the crisis by mandating GMO labeling based on threshold
amounts to allay public fears.
A. The Current US Debate Over Mandatory GMO Labeling
Section II.A.1 introduces the current US debate over mandatory
GMO labeling while Sections II.A.2 and II.A.3 discuss the Consumer
Right to Know Policy. Sections II.A.4, II.A.5, and II.A.6 explain and
contrast the now preempted GMO labeling laws of Connecticut,
Maine, and Vermont while Section II.A.7 highlights some of the
backlash to these state laws from companies opposing mandatory
GMO labeling. Section II.A.8 describes the initial federal reaction to
these state laws through H.R. 1599, while Section II.A.9 explains S.
764, which nationalized GMO labeling requirements based on the
presence of bioengineered substance in final food products. Section
II.A.10 presents an overview of the reaction to S. 764. Section II.B
explains how the critical dispute between the Member States and the
European Union Commission over the approval of Bt-maize in 1997
was resolved through the adoption of stricter mandatory labeling
requirements under the current Traceability and Labeling Regulation.
Section II.B also explains what is required under the Traceability and
Labeling Regulation for approved GMOs in the European Union.
While the overwhelming majority of US citizens desire
mandatory GMO labeling, the United States long resisted requiring
labeling for GMOs and consistently refused to address the concerns of
such individuals.
358
This incongruence led several states to take action
and respond to their citizens’ dissent by taking steps to require GMO
labeling within their own borders.
359
As this movement spread across
the United States at a fast pace, it prompted the US Congress to
quickly respond and eventually led to the implementation of national
358. See generally supra Section I.A (explaining the US federal policy on GMOs under
the Coordinated Framework and the 1992 FDA Statement of Policy).
359. See infra Sections II.A.3-4, 6 (describing the actions of the states of Connecticut,
Maine, and Vermont).
688 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
GMO labeling requirements under S. 764 that brought about the
demise of the state GMO labeling laws of Connecticut, Maine, and
Vermont.
360
However, before examining this revolutionary movement
and federal reaction, it is important to understand why so many
individuals desire GMO transparency.
361
The Consumer Right to
Know Policy contains many of the justifications for mandatory GMO
labeling and presents a consistent platform for individuals who argue
for GMO labeling generally and for those who continue to argue for
stricter measures than those provided for in S. 764.
362
1. The Consumer Right to Know Policy
As previously discussed, the FDA considers GMOs to be GRAS
and does not require independent testing of such products before
placement on the market.
363
However, many argue for labeling of
GMOs despite the FDA’s determination based on the Consumer Right
to Know Policy, which supports GMO labeling laws based on the
rights of consumers to be able to choose whether or not they purchase
and consume food products containing GMOs.
364
The right does not
depend on whether or not fears concerning GMOs have scientific
foundation or if the FDA finds a material difference between GMO
foods and their traditional counterparts.
365
It instead addresses the
360. See infra Sections II.A.8-9 (giving an overview of the federal response).
361. See infra Section II.A.1 (providing arguments for GMO transparency under the
Consumer Right to Know Policy).
362. See infra Section II.A.1 (describing these justifications, which are used by many
GMO labeling proponents).
363. See supra Section I.A.3 (detailing the FDA’s policy on these issues).
364. See Gary Hirshberg, Mandatory GMO Labeling—It’s Your Right to Know,
H
UFFINGTON POST (July 21, 2015, 11:30 AM), http://www.huffingtonpost.com/gary-
hirshberg/mandatory-gmo-labeling—i_b_7841144.html (detailing some of the motivations
behind the Consumer Right To Know policy, including inadequate research on the long-term
effects of GMOs, increased herbicide use, and religious and ethical views); Jon Entine, Anti-
GMO ‘Big Lie’: Is Labeling Really About Our “Right to Know?”, G
ENETIC LITERACY
PROJECT (Oct. 16, 2015), https://www.geneticliteracyproject.org/2015/10/16/anti-gmo-big-lie-
labeling-really-right-know/ (citing the many national and international organizations that have
concluded that genetically engineered crops are as safe as any other and that they pose no
special risks to the environment or humans).
365. See generally James Hamblin, No One Is Denying A ‘Right To Know What’s In My
Food’”, A
TLANTIC (July 24, 2015), http://www.theatlantic.com/health/archive/2015/07/no-
one-is-denying-a-right-to-know-whats-in-my-food/399536/ (articulating that the majority of
Americans currently believe that any and all genetically modified foods are “inherently
2017] GMO LABELING IN THE US AND EU 689
concerns of a majority of the US public who desire GMO labeling and
allows citizens to make informed decisions as to whether they wish to
consume foods containing GMOs and those produced through genetic
engineering.
366
There are a myriad of reasons why consumers do not want to
consume GMOs or foods made using genetic engineering, including
religious and ethical reasons, that are independent of human safety
concerns.
367
For example, a Jewish person observing religious dietary
laws might be primarily concerned with avoiding foods made with
certain meats or animal products in order to keep his or her strict
Kosher diet.
368
Furthermore, many believe that genetic engineering
allows corporations to “play God,” which violates their religious
beliefs.
369
Other reasons might be that people may choose to avoid
certain foods for ethical reasons, while others may want to eat an “all
natural” diet without consuming any food that has been modified or
unhealthful” in spite of the “assurances to the contrary” from bodies such as the FDA, The
World Health Organization and the American Medical Association); Steve Keane, Can a
Consumer’s Right To Know Survive The WTO?: The Case of Food Labeling, 16 T
RANSNAT’L
L. & CONTEMP. PROBS. 291, 302 (2006) (stating that the concept of the Consumer Right to
Know is not always grounded in health and safety concerns).
366. See David Alan Nauheim, Food Labeling and the Consumer Right to Know: Give
the People What They Want, 4 L
IBERTY U. L. REV. 97, 103-04 (2009) (describing many of the
reasons for consumer alarm regarding GMOs and stating that thirty-seven percent object to
GMOs on religious grounds); Keane, supra note 365, at 302 (describing some of the
justifications under the Consumer Right To Know policy, including religious or ethical dietary
restrictions, environmental concerns, or opposition to production methods).
367. See Sarah L. Kirby, Genetically Modified Foods: More Reasons To Label Than Not,
6 D
RAKE J. AGRIC. L. 351, 357 (2001) (giving the example of Jewish individuals who might
violate their religious beliefs by consuming certain GMOs); Emmanuel B. Omobowale, Peter
A. Singer, & Abdullah S. Daar, The Three Main Monotheistic Religions and GM Food
Technology: An Overview Of Perspectives, B
IOMED CENTRAL (Aug. 22, 2009),
http://bmcinthealthhumrights.biomedcentral.com/articles/10.1186/1472-698X-9-18 (providing
for some of the concerns specific to Jewish individuals with respect to consuming GMOs).
368. See Omobowale, Singer, & Daar, supra note 367 (describing many of the religious
arguments concerning GMOs). See generally Nauheim, supra note 366, at 103 (explaining
some of the concerns about GMOs with respect to Judaism).
369. See Nauheim, supra note 366, at 103 (explaining these religious arguments under
the Consumer Right To Know policy); Omobowale, Singer, & Daar, supra note 367
(analyzing the religious concerns of those who believe that biotechnology interferes with
God’s role as the Creator). See generally Amaru, supra note 19, at 580 (stating that there
might be religious reasons why individuals wish to avoid GMOs).
690 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
altered by scientific technology.
370
Another group of individuals who
might wish to avoid GMOs are individuals with allergies who need to
avoid certain allergens that might be present in genetically modified
foods.
371
To all of these groups, the potential safety concerns might be
secondary to their commitment to eating food that has not been
genetically modified or contains GMOs.
372
2. The Consumer Right to Know Policy & The Courts
In Alliance for Bio-Integrity v. Shalala, the court found that the
Consumer Right to Know Policy was not a sufficient basis for a food
labeling law on its own when the FDA did not find a material
difference between GE foods and their traditional counterparts.
373
The
court also held that a consumer’s right to know could only be
considered once a material difference was found between GMO and
non-GMO products.
374
Since the Consumer Right to Know Policy
was not an adequate basis for mandating GMO labeling, the court
dismissed the case.
375
The Consumer Right to Know Policy was also rejected in
International Dairy Food Association v. Amestoy as a sufficient basis
for a Vermont statute that mandated labeling for milk products
containing rBST, a genetically modified hormone.
376
The US Court of
Appeals for the Second Circuit ruled that because the FDA found that
dairy products derived from cows treated by rBST were
370. See Keane, supra note 365, at 302 (stating some of the ethical and moral reasons for
consumer demand to know the GMO status of the food they are consuming); Amaru, supra
note 19, at 580 (noting that many people might have ethical or moral objections to genetic
engineering that are not dependent on whether or not GMOs have been proven safe); Kirby,
supra note 367, at 357 (providing examples of those who morally and ethically oppose
GMOs).
371. See Kirby, supra note 367, at 357 (discussing concerns that genetically modified
foods may set off allergies); Strauss, supra note 158, at 109 (explaining that allergies are a
major concern with genetically modified foods).
372. See Kirby, supra note 367, at 357 (describing some of the interests at issue as much
deeper than mere consumer concern); Amaru, supra note 19, at 580 (citing many examples of
individuals who wish to avoid GMOs despite how safe they have been proven to be).
373. See Alliance for Bio-Integrity v. Shalala, 116 F.Supp.2d at 179.
374. Id. (finding that the FDA could consider consumer demand once materiality has
been established).
375. Id.
376. See Int’l Dairy Foods Ass’n v. Amestoy, 92 F.3d 67 (2d Cir. 1996).
2017] GMO LABELING IN THE US AND EU 691
“indistinguishable” from products from untreated herds, the Vermont
consumers’ desire to know if the product contains rBST was
insufficient to allow Vermont to force dairy manufacturers to speak
against their will.
377
Specifically, the court stated that it knew of no
case where consumer interest by itself was enough to justify requiring
a product’s manufacturers to make public a statement about a
production method that has no discernable impact on a final
product.
378
While these cases do not involve the GMO regulations that are
discussed in this Note, they are important to consider with respect to
mandating GMO labeling based on the Consumer Right to Know
Policy.
379
As will be discussed below, three states passed GMO
labeling laws based on this Policy, as state legislatures listened to the
demands of their citizens for greater GMO transparency.
380
While
these state laws would later be preempted by the new federal national
standard under S. 764, the Consumer Right to Know Policy continues
to be a strong argument for those arguing for stricter labeling
requirements and those who oppose the new federal national standard
under S. 764 for various reasons.
381
3. Connecticut’s GMO Labeling Law
In June 2013, Connecticut passed the nation’s first state GMO
labeling law, which began the state movement towards mandatory
labeling for GMOs.
382
Connecticut General Statutes §21a-92c state
377. Id. at 74 (detailing the court’s rationale for ruling that the consumers’ desire to
know about the GMO status of their food was not sufficient to overcome the First Amendment
rights of the manufacturers); see also Nauheim, supra note 366, at 122 (discussing the court’s
finding that consumer interest was not sufficient and that the Vermont legislature did not
satisfy the second prong of the Central Hudson test by having a substantial interest in
regulating the commercial speech at issue).
378. See Amestoy, 92 F.3d at 74 (discussing the non-existence of such a case).
379. See supra Section II.A.1 (explaining the Consumer Right to Know Policy).
380. See infra Sections II.A.3-4, 6 (describing how the states of Connecticut, Maine, and
Vermont enacted laws mandating GMO labeling in response to high public demand for such
legislation).
381. See infra Section II.A.9 (stating that S. 764 preempts these state laws).
382. See 2013 Conn. Acts 777 (Reg. Sess.) (codified at scattered sections of Conn. Gen.
Stat. Ann. §21a); Connecticut passes first GMO labeling law in US, RT (June 5, 2013, 3:46
AM), https://www.rt.com/usa/connecticut-first-gmo-labeling-law-241/ (describing how
Connecticut was the first state to pass a mandatory GMO labeling law); see also Michele
692 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
that seed or seed stock intended to produce food for human
consumption and food intended for human consumption that was
introduced or delivered for introduction into commerce in the state of
Connecticut that was entirely or partially genetically engineered had
to be labeled.
383
Particularly, items contained in a package for retail
sale were to be labeled with the clear and conspicuous words
“Produced with Genetic Engineering.”
384
In addition to requiring such
labeling, the state of Connecticut circumvented the FDA and defined
“natural food” in General Statutes Ann. §21a-92(17) as food “(A) that
has not been treated with preservatives, antibiotics, synthetics
additives, artificial flavoring or artificial coloring; and (B) that has not
been processed in a manner that makes such food significantly less
nutritive; and (C) . . . that has not been genetically engineered.”
385
Thus, the Connecticut legislature agreed with the public’s view that
food that has been genetically engineered should not be labeled as
“natural” and should instead be labeled as genetically engineered.
386
The burden of compliance with the law rested on the party that
was selling, offering for sale, or distributing any product in
Connecticut that was required to be labeled under the law.
387
Genetically engineered products exempted from the law included
processed food intended for immediate consumption, food sold in a
restaurant or similar food facility, alcoholic beverages, farm products
sold at a pick-your-own farm stand, and food consisting of or derived
from an animal that was injected with or fed any genetically
engineered food or drugs.
388
Furthermore, it is important to note
Simon, Connecticut Makes History as First State to Pass GMO Food Labeling Law, FOOD
DEMOCRACY NOW (June 4, 2013, 3:45 PM), http://www.fooddemocracynow.org/blog/2013/
jun/4/connecticut_1st_state_2_pass_gmo_labeling_bill (assessing how Connecticut became
the first state to pass a GMO labeling law). See generally Muller, supra note 11, at 526-27
(discussing Connecticut’s GMO labeling law).
383. See Conn. Gen. Stat. Ann. § 21a-92c (2015) (describing what items the law applied
to); Nunziato, supra note 9, at 484 (discussing this part of the statute).
384. See Conn. Gen. Stat. Ann. §21a-92c(a)(ii) (setting forth the labeling requirements
for items on the market in a package for retail sale).
385. Conn. Gen. Stat. Ann. §21a-92(17) (defining “natural”).
386. See supra Section I.A (discussing the public attitude in the United States towards
GMO labeling and the use of “natural” on products that have been genetically engineered).
387. See Conn. Gen. Stat. Ann. § 21a-92c(c) (explaining who had the burden to ensure
compliance with the law).
388. See Conn. Gen. Stat. Ann. § 21a-92c(b) (exempting certain products from the Act).
2017] GMO LABELING IN THE US AND EU 693
Connecticut’s choice of label.
389
Instead of looking at only the end
product and whether it contained a threshold amount of GMOs—as
the European Union does—the Connecticut Act focused more on the
procedure used to produce the food and used a label that indicated the
method with which the food was produced (instead of a specific
breakdown of any GMO components).
390
4. Maine’s GMO Labeling Law
Less than six months after Connecticut passed its labeling law,
Maine enacted its own bill titled “An Act To Protect Maine Food
Consumers’ Right To Know about Genetically Engineered Food and
Seed Stock.”
391
The Maine law also required genetically engineered
food and seed stock to be conspicuously labeled as “[p]roduced with
Genetic Engineering.”
392
While Maine’s law did not define “natural”
as Connecticut’s law did, the law prohibited foods that were subject to
the labeling requirements from being described as “natural” or with a
similar identification.
393
Among the foods exempted from the law
were products that had been produced without knowledge that the
products or ingredients used were genetically engineered and animal
products derived from an animal that was not genetically engineered
but was fed genetically engineered food.
394
389. See Conn. Gen. Stat. Ann. § 21a-92c (requiring labeling for products made through
genetic engineering, not based on a threshold amount of GMO in the final product).
390. See Conn. Gen. Stat. Ann. § 21a-92c (mandating labeling of products made through
genetic engineering).
391. See Me. Rev. Stat. Ann. tit. 22, § 2591 (2013); Muller, supra note 11, at 527
(introducing the Maine bill mandating GMO labeling); Ross H. Pifer, Mandatory Labeling
Laws: What Do Recent State Enactments Portend for the Future of GMOs?, 118 P
ENN ST. L.
REV. 789, 804 (2013-2014) (explaining the Maine bill).
392. See Me. Rev. Stat. Ann. tit. 22, § 2593; Muller, supra note 11, at 527 (noting the
similarities between the two laws and describing Maine’s labeling requirements); Pifer, supra
note 391, at 804 (describing how food offered for retail sale that was genetically engineered
had to be labeled).
393. See Conn. Gen. Stat. Ann. §21a-92(17) (defining “natural”); Me. Rev. Stat. Ann. tit.
22, § 2593; Muller, supra note 11, at 528 (noting that while the Connecticut law defined
“natural,” the Maine bill did not).
394. See generally Me. Rev. Stat. Ann. tit. 22, § 2593 (listing the exemptions).
694 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
5. Connecticut and Maine’s Trigger Clauses
While Connecticut and Maine were the first two states to pass
GMO labeling laws, the laws did not have a set date to go into effect
because of trigger clauses that constrained both acts.
395
The
Connecticut Act had three requirements.
396
The first requirement was
that four states (not including Connecticut) enact a mandatory
labeling law for GE foods similar to its own.
397
For this requirement,
the list of states that could have fulfilled this requirement was Maine,
New York, Rhode Island, New Jersey, Massachusetts, Vermont, and
Pennsylvania.
398
Secondly, one of the states that passed similar
legislation had to border Connecticut.
399
Third, the aggregate
population of such states located in the northeast region of the United
States that enacted a mandatory GMO labeling law had to be more
than twenty million based on the 2010 census.
400
Under the Maine
trigger clause, substantially similar legislation had to be adopted in at
least four contiguous states.
401
If this requirement was not fulfilled
before January 1, 2018, the act would have been repealed.
402
These
trigger clauses were incorporated into the Connecticut and Maine
GMO labeling laws as a means of protection.
403
Specifically, they
395. See Nunziato, supra note 9, at 485-86 (discussing the similar trigger clauses of
Connecticut and Maine); Muller, supra note 11, at 527-28 (explaining how both laws did not
go into effect due to their trigger clauses).
396. See Muller, supra note 11, at 527 (detailing the requirements under the Connecticut
trigger clause); Nunziato, supra note 9, at 485-86 (analyzing the trigger clause for the
Connecticut law).
397. See Nunziato, supra note 9, at 526-27 (detailing the first requirement under the
Connecticut trigger); Muller, supra note 11, at 527 (setting forth what was first required).
398. See Nunziato, supra note 9, at 485-86 (listing the states that could have fulfilled the
first requirement). See generally Muller, supra note 11 (explaining the geographic
specifications of this requirement).
399. See Muller, supra note 11, at 527 (putting forth the requirement that one of the
states must border Connecticut); Nunziato, supra note 9, at 485-86 (explaining this second
requirement).
400. See Muller, supra note 11, at 527 (noting the second requirement under the trigger
clause); Nunziato, supra note 9, at 485-86 (discussing the aggregate population requirement).
401. See Me. Rev. Stat. Ann. tit. 22, § 2595 (2013) (explaining the circumstances
surrounding the trigger clause).
402. Id. (setting this deadline).
403. See infra note 404 and accompanying text (discussing the justifications for the
trigger clauses).
2017] GMO LABELING IN THE US AND EU 695
were meant to ensure that no single state would be targeted if a state’s
GMO labeling law became the center of a lawsuit.
404
6. Vermont’s Labeling Law
The most recent state GMO labeling law to be enacted was the
Vermont Labeling Act, known as Act 120, which was signed on May
8, 2014.
405
Similar to the laws of Connecticut and Maine, Act 120
required that food offered for sale by a retailer to be labeled as
produced entirely or in part from genetic engineering if it was a
product (1) offered for retail sale in Vermont and (2) entirely or
partially produced with genetic engineering.
406
When the product was
a packaged raw agricultural commodity, the manufacturer would have
to label the package that was offered for retail sale with the clear and
conspicuous words “produced with genetic engineering.”
407
If the
product was a raw agricultural commodity that was not separately
packaged, the retailer would be required to post a label on the retail
store shelf or bin where the commodity was displayed for sale with
the clear and conspicuous words “produced with genetic
engineering.”
408
And finally, if a processed food contained a product
or products of genetic engineering, the manufacturer would need to
label the package with the words “partially produced with genetic
engineering,” “may be produced with genetic engineering,” or
“produced with genetic engineering.”
409
404. See Amaru, supra note 19, at 592 (explaining that the trigger clauses were intended
to ensure that no single state would be targeted if the legislation was the subject of a lawsuit);
Muller, supra note 11, at 527 (explaining that the stipulations were “put in place in order to
protect small businesses and farmers from suffering at the hands of out-of-state competitors”
who were not required to label food products that were genetically engineered).
405. See No. 120. An Act Relating To The Labeling Of Food Produced With Genetic
Engineering, 2014 Vt. Acts & Resolves No. 120 [hereinafter Act 120], available at
http://www.leg.state.vt.us/docs/2014/Acts/ACT120.pdf.
406. See Act 120, supra note 405, §3043(a) (mandating when a food be labeled as
produced with genetic engineering).
407. Id. §3043(b)(1) (setting forth requirements for packaged raw agricultural
commodities).
408. Id. §3043(b)(2) (giving instructions for raw agricultural commodities that are not
separately packaged).
409. Id. §3043(b)(3) (stating the requirements for processed foods that contain a product
or products of genetic engineering).
696 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
While Act 120 was similar to the Connecticut law in many ways,
it differed in one important aspect.
410
Like the Maine law, Act 120 did
not define the term “natural” in the text of the Act.
411
Act 120 clearly
forbade manufacturers of foods produced entirely or in part from
genetic engineering from labeling their products as “natural,”
“naturally made,” “naturally grown,” “all natural,” or “any word of
similar import” that would have a tendency to mislead a consumer.
412
Act 120 also specifically stated that the law should not be construed
to require a list or identification of any ingredient or ingredients that
were genetically engineered or the placement of the term “genetically
engineered” immediately preceding any common name or primary
product descriptor of a food.
413
The purpose of Act 120 was to establish a system by which
people make informed decisions regarding the potential health effects
of the food they purchase and consume.
414
The Statute was also
intended to inform the purchasing decisions of consumers who are
concerned about the potential effects on the environment of GE
foods.
415
The Act was also meant to reduce consumer confusion and
deception by prohibiting the labeling of GE products as “natural.”
416
In addition to promoting the disclosure of factual information on food
labels, the Act was meant to provide data to consumers in order to
make informed decisions for religious reasons, such as keeping
Kosher for observant Jewish individuals.
417
410. See Muller, supra note 11, at 526-28 (describing Connecticut’s GMO law); Davis,
supra note 35, at 46-48 (detailing the requirements of Act 120).
411. See Muller, supra note 11, at 527-28 (stating that unlike the Connecticut law,
Maine’s law did not define “natural”).
412. See Act 120, supra note 405, §3043(c) (setting forth the restrictions on the use of
“natural” with respect to foods produced using genetic engineering in Vermont); Davis, supra
note 35, at 47-48 (explaining that products manufactured with GMOs could not be labeled as
“natural” under Act 120).
413. See Act 120, supra note 405, §§3041(1-2) (explaining how neither of these labels
are required under the Act).
414. See id. §3041(1) (setting forth the Act’s Legislative Purpose).
415. See id. § 3041(2) (stating this statutory purpose).
416. See id. §§3041(1-3) (recognizing consumer choice in the Act’s Legislative
Purpose).
417. See id. §3041(4) (addressing the religious concerns of people who wish to avoid
GMOs).
2017] GMO LABELING IN THE US AND EU 697
Perhaps the most crucial part of Act 120 that distinguished it
from the labeling laws of Connecticut and Maine was that it did not
contain a trigger clause.
418
The ramifications of excluding a trigger
clause became costly when the Grocery Manufacturer’s Association
(“GMA”) sued the state of Vermont a month after the bill was signed,
claiming that the law violated its right to free speech and would cost
too much to comply with.
419
Despite this immediate backlash,
Vermont Governor Peter Shumlin signed the bill to go into effect in
July of 2016.
420
While Vermont’s law counted toward fulfilling the
trigger requirements of the Connecticut and Maine laws, it was not
constrained by any state requirement or population requirement in
order to go into effect.
421
Furthermore, as opposed to the Connecticut
and Maine laws, the Vermont Law was not subject to repeal if other
states in the Northeast United States failed to enact similar laws.
422
As
418. See James J. Gormley, GMO-Labeling Laws: Why The Trigger Clause?,
N
UTRITIONAL OUTLOOK (Apr. 4, 2014), http://www.nutritionaloutlook.com/articles/gmo-
labeling-laws-why-trigger-clause (stating that unlike Maine and Connecticut, Vermont’s GMO
labeling law did not contain a trigger clause); Dan Flynn, State Legislatures Pass On Adopting
GMO-Labeling Policies This Year, F
OOD SAFETY NEWS (June 24, 2015), http://www.
foodsafetynews.com/2015/06/states-pass-on-opportunities-to-jump-ahead-of-feds-on-gmo-
labeling-policy/#.Vrve18ac8UV (stating that while Act 120 was to go into effect in July 2016,
Maine and Connecticut’s laws are contingent upon the actions of bordering states).
419. See Grocery Mfrs. Ass’n v. Sorrell, 102 F.Supp.3d 583 (D. Vt. 2015).
420. See Vermont Governor Signs First In US GMO-Labeling Law To Go Into Effect,
RT (May 8, 2014, 7:14 PM), https://www.rt.com/usa/157744-vermont-gmo-labeling-signed/
(announcing that despite threats from Monsanto legal action against the state, Vermont’s
Governor signed the bill into law to go into effect in July 2016); Dave Gram, After Vermont
Passes GMO Labeling Law, Food Industry Announces Plans To Sue, C
ORNUCOPIA INST.
(May 9, 2014), https://www.cornucopia.org/2014/05/vermont-passes-gmo-labeling-law-food-
industry-announces-plans-sue/ (discussing the action taken by GMA shortly after Governor
Shumlin signed the bill into law).
421. See Nunziato, supra note 9, at 485-86 (stating that Vermont was one of the states
that was included in the trigger clauses of the Connecticut and Maine GMO labeling laws);
Jeff Daniels, GMOs: Congress May Block States From Requiring Labeling, CNBC (July 22,
2015, 12:31 PM), http://www.cnbc.com/2015/07/22/gmos-congress-may-block-states.html
(explaining how Act 120 was to go into effect in 2016 while Connecticut and Maine’s laws
would only go into effect when the conditions of their trigger clauses were met); Cathy
Siegner, Vermont Senate Approves GMO Labeling Bill, Sends It Back To House For Final
Vote, F
OOD SAFETY NEWS (Apr. 17, 2014), http://www.foodsafetynews.com/2014/04/
vermont-senate-approves-gmo-labeling-bill-sends-it-back-to-house/#.Vrv4I8ac8UU
(distinguishing Vermont’s Law as not having a trigger clause as opposed to those of
Connecticut and Maine).
422. See Nunziato, supra note 9, at 485-86 (discussing how the laws of Connecticut and
Maine were to be repealed if their trigger clauses were not fulfilled); see also Gormley, supra
698 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
will be demonstrated in Section II.A.9, Act 120 was a substantial
factor in the passing of S. 764 and thus played a large role in the
nationalization of GMO labeling requirements in the United States.
423
7. Backlash to State Labeling Laws
While many anti-GMO and pro-labeling groups praised the
passing of these labeling measures, these state laws were faced with
immense opposition and were questioned by many as to their
constitutionality, practicality, and legality.
424
While Connecticut was
able to enact GMO legislation in 2013, there was discussion that
legislators were getting cold feet after Monsanto threatened to sue the
state.
425
Since many legislators believed that Monsanto would win
this legal battle, there was much hesitation surrounding the
Connecticut labeling law.
426
After Monsanto similarly threatened to
sue Vermont when Act 120 was being drafted, the Grocery
Manufacturers Association sued the state.
427
In this suit, GMA argued
note 418 (distinguishing Act 120 from the GMO laws of Maine and Connecticut, which have
trigger clauses).
423. See infra Section II.A.9 (demonstrating the importance of Act 120 and its impact on
mandating federal GMO labeling under S. 764).
424. See Liza Baertlein, U.S. Food Makers Sue to Stop Vermont’s GMO Labeling Law,
R
EUTERS (June 12, 2014, 6:44 PM), http://www.reuters.com/article/vermont-gmo-idUSL2
N0OT20620140612 (announcing that GMA, the Snack Food Association, the International
Foods Association, and the National Association of Manufacturers were opposing the Vermont
GMO labeling law through a lawsuit); Vermont’s Landmark GMO-Labeling Law Target of
Lawsuit By Food Trade Groups, RT (June 13, 2014, 11:57 PM), https://www.rt.com/usa/
165860-vermont-gmo-labeling-lawsuit/ (discussing the claims of the national trade
organizations suing the state of Vermont).
425. See Mat McDermott, Connecticut Fears Monsanto - Bill To Label GM Ingredients
Dead Due To Lawsuit Worries, T
REEHUGGER (May 8, 2012), http://www.treehugger.com/
environmental-policy/connecticut-fears-monsanto-bill-label-genetically-modified-ingredients-
dead-lawsuit-worries.html (describing how legislators were getting cold feet in light of
Monsanto lawsuit concerns); Analiese Paik, Connecticut’s GE Foods Bill Eviscerated By
Lawyers, F
AIRFIELD GREEN FOOD GUIDE (May 5, 2012, 10:06 AM), http://fairfieldgreenfood
guide.com/2012/05/05/connecticuts-ge-foods-bill/ (explaining how legislators feared
mandating labeling due to fears of a Monsanto lawsuit).
426. See McDermott, supra note 425 (explaining the cause behind this hesitation); Paik,
supra note 425 (discussing the effect of this threat from Monsanto).
427. See Christina Sarich, Groups File Lawsuit Over Vermont’s New GMO Labeling
Law, N
AT. SOC’Y (June 18, 2014), http://naturalsociety.com/4-gma-groups-file-federal-
lawsuit-vermonts-new-gmo-labeling-law/ (giving an overview of the lawsuit); Nancy Remsen,
Trade Groups Sue VT Over GMO Labeling Law, B
URLINGTON FREE PRESS (June 13, 2014,
2017] GMO LABELING IN THE US AND EU 699
that the state’s GMO labeling law violated the First Amendment
protection of commercial speech as well as the dormant Commerce
Clause.
428
It is important to note that many other large and influential
companies belong to this Association, including Monsanto, The
Coco-Cola Company, Del Monte Foods Company, General Mills,
Inc., Kraft Foods Group, The Proctor & Gamble Company, and S.C.
Johnson & Son, Inc.
429
While these companies have not individually
sued any states or were named plaintiffs in any case, they do belong
to the same GMA that sued the state of Vermont, demonstrating the
strong resistance to such state laws.
430
Companies that oppose GMO labeling laws have also allocated
their resources to defeat state labeling laws when such measures came
to a vote.
431
For example, California’s Proposition 37, which would
have required labeling on raw or processed foods if they were made
from plants or animals with genetic material changed in specific
ways, was defeated by the “Vote No” campaign, which raised US$46
7:00 AM), http://www.burlingtonfreepress.com/story/news/politics/2014/06/12/gma-sues-vt-
gmo-law/10389209/ (detailing the lawsuit filed by GMA, the Snack Food Association, the
International Dairy Foods Association, and the National Association of Manufacturers against
the state of Vermont).
428. See GMA Files Lawsuit To Overturn Vermont’s Unconstitutional Mandatory GMO
Labeling Law, GMAO
ONLINE (June 13, 2014), http://www.gmaonline.org/news-events/
newsroom/gma-files-lawsuit-to-overturn-vermonts-unconstitutional-mandatory-gmo-label/
(explaining the grounds for the lawsuit); Sarich, supra note 427 (explaining the arguments of
GMA).
429. See GMA Board of Directors, GMA
ONLINE, http://www.gmaonline.org/forms/
committee/CommitteeFormPublic/viewExecCommittee?id=16E3DD0000014F (listing the
Board of Directors, many of which belong to these companies); Ronnie Cummins, The Great
Boycott: Monsanto And The GMA, O
RGANIC CONSUMERS ASS’N (May 14, 2014), https://
www.organicconsumers.org/essays/great-boycott-monsanto-and-gma (stating that members of
the GMA include Monsanto, Coca-Cola, and General Mills).
430. See Cummins, supra note 429 (listing the members of GMA); GMA Files Lawsuit
to Overturn Vermont’s Unconstitutional Mandatory GMO Labeling Law, GMA
ONLINE (June
13, 2014), http://www.gmaonline.org/news-events/newsroom/gma-files-lawsuit-to-overturn-
vermonts-unconstitutional-mandatory-gmo-label/ (providing the news release from GMA
announcing its lawsuit against Vermont).
431. See Kimbrell & Paulsen, supra note 38, at 345 (“[Lobbying disclosures] show
expenditures specifically for opposing GE good labeling (as opposed to more general, related
topics) of over US$80 million between 2012 and the first quarter of 2014 . . . .”); Libby Foley,
Corporate Spending to Fight GMO Labeling Skyrockets, E
NV’T WORKING GROUP (Apr. 23,
2015), http://www.ewg.org/research/anti-label-lobby (explaining that in 2014, food and
biotechnology companies that oppose mandatory GMO labeling have disclosed expenditures
of US$63.6 million to lobby for legislation that reference to GMO labeling).
700 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
million from some of the biggest businesses in the industry, as
opposed to supporters of the proposition that raised US$8 million.
432
This pattern occurred in states such as Washington and Oregon,
where companies such as Monsanto were able to greatly outspend
proponents of the GMO labeling bills and the voters rejected the
initiatives.
433
It is clear that in the states where the GMO labeling
issue was brought to the voters, companies such as Monsanto and
organizations such as the GMA put a great amount of money and
effort into convincing voters not to support GMO labeling laws.
434
8. H.R. 1599 & The Federal Reaction to State GMO Labeling Laws
Members of the US House of Representatives took action to
oppose the state GMO labeling laws in July 2015 when the House
passed H.R. 1599.
435
Titled the “Safe and Accurate Food Labeling
Act,” H.R. 1599 would have prohibited any state from enacting laws
requiring the labeling of GMOs or GE foods.
436
According to H.R.
432. See California Proposition 37, Mandatory Labeling of Genetically Engineered
Food (2012), B
ALLOTPEDIA, https://ballotpedia.org/ California_ Proposition_37,_Mandatory_
Labeling_of_Genetically_Engineered_Food_(2012) (last visited Jan. 9, 2016) (discussing
generally California Proposition 37, including donors for the measure and donors against it);
Organic Consumers Association Calls for Boycott of Organic Brand Parent Companies That
Helped Defeat Prop 37, O
RGANIC CONSUMERS ASS’N (Nov. 15, 2012), https://www.organic
consumers.org/press/organic-consumers-association-calls-boycott-organic-brand-parent-
companies-helped-defeat-prop (listing companies who donated to the NO on 37 campaign).
433. See Jeff Mapes, Grocery Manufacturers Disclose Big Donors in GMO Labeling
Campaign in Washington, O
REGON LIVE (Oct. 18, 2013, 5:29 PM), http://www.oregonlive.
com/mapes/index.ssf/2013/10/grocery_manufacturers_disclose.html (indicating that GMA
revealed that PepsiCo, Nestle USA, and Coca-Cola each gave US$1 million to the campaign
against the Washington initiative in hidden donations); Oregon Mandatory Labeling of GMOs
Initiative, Measure 92 (2014), B
ALLOTPEDIA, https://ballotpedia.org/ Oregon_Mandatory_
Labeling_of_GMOs_Initiative,_Measure_92_ (2014) (last visited Feb. 7, 2016) (generally
discussing the Oregon Mandatory Labeling of GMOs Initiative and the donors who supported
the measure as well as those who opposed it).
434. See Mapes, supra note 433 (discussing the efforts of several large companies to
stop GMO labeling efforts at the state level); Kimbrell & Paulsen, supra note 38, at 345
(discussing the amount of money spent on lobbying against GMO labeling measures).
435. See Safe and Accurate Food Labeling Act of 2015, H.R. 1599, 114
th
Cong. (1st
Sess. 2015) [hereinafter H.R. 1599] (dating the passage of H.R. 1599 as July 24, 2015).
436. Id. § 113 (prohibiting all states from directly or indirectly establishing as to any
food in interstate commerce “any requirement with respect to the sale of offering for sale in
interstate commerce of a genetically engineered plant for use or application in food that is not
identical to the requirement of section 461 of the Plan Protection Act (as added by section 111
of this Act)”).
2017] GMO LABELING IN THE US AND EU 701
1599, the fact that genetic engineering took place during the
production of a food does not “by itself” serve as material information
when assessing any possible differences between a food that is
produced from, contains, or consists of a GE plant and one that does
not.
437
According to the bill, GMO labeling could only be required if
there is a material difference in functional, nutritional, or
compositional characteristics, allergenicity, or other attributes
between the GMO and non-GMO foods.
438
Furthermore, the
disclosure of such a material difference would have to be necessary to
protect public health or safety or to prevent the labeling of the food
from being false or misleading.
439
Thus, under the law, no GMO
labeling laws could have been established until the US government
changed its twenty-three year stance on GMOs and found that GMO
foods present a material difference in the above listed categories.
440
This requirement reflected the ruling in District of Columbia in
Alliance for Bio-Integrity v. Shalala, where the court ruled that the
FDA would have to find a material difference between GMO and
non-GMO food in order to require such labeling under the FDCA.
441
Furthermore, this law would have meant that even if the FDA found
that there was a material difference between GMO foods and non-
GMO foods, GMO labeling would still not be possible unless it was
shown that such labeling would be necessary to prevent consumer
confusion or falsity or harm to the public.
442
According to the Committee on Agriculture’s report, one of the
biggest motivations behind the Bill was the concern over the possible
“patchwork” system of GMO labeling that would result in the United
437. See id. § 101 (amending Chapter IV of the FDCA by adding section 424 titled
“Food Derived from New Plant Varieties”).
438. See id. § 101(2)(A) (asserting that there must be a material difference in one of
these attributes in order to require labeling for GMO products).
439. See id. § 101(2)(B) (requiring that the disclosure of this material difference be
necessary to protect public health and safety or to prevent the label of the food from being
false or misleading).
440. See generally id. §§ 101(2)(A-B) (clearly indicating that without these two
conditions met, products containing GMOs or derived from genetic engineering cannot be
labeled as such).
441. See Alliance for Bio-Integrity v. Shalala, 116 F.Supp.2d 166 (D.C. Cir. 2000).
442. See generally H.R. 1599, supra note 435, at § 101(2)(A-B) (explaining that in order
for the Secretary to be able to require GMO labeling, both (A) and (B) must be fulfilled).
702 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
States if states were permitted to enact their own labeling laws.
443
The
Committee also focused heavily on the immense burden these state
laws would impose upon producers and companies, including an
estimate from a food industry association that claimed the strict
liability scheme of Vermont’s Act 120 could result in fines as much
as US$10 million per day due to inevitable slips in the system that
would cause mislabeled GMO products to be put on the shelves.
444
According to the Committee, the solution was the Safe and Accurate
Food Labeling Act, which would continue to administer the voluntary
consultation process established by the 1992 FDA Statement of
Policy.
445
Specifically, the Committee intended H.R. 1599 to
recognize the FDA 1992 Statement of Policy.
446
With respect to
consumers’ desire to know if they are purchasing foods made using
genetic engineering, the bill provided for a voluntary genetically
engineered certification program within the USDA that would
nationally govern label claims regarding the use or non-use of genetic
engineering in food production or processing.
447
In the report, the Committee asserted that it intended for this
program to provide the sole standard by which all food producers,
handlers, and processors may make claims regarding the use of
genetic engineering in the production and processing of food.
448
This
would have included claims for foods that were within the definition
of raw or processed agricultural products and for foods that were not,
as well as for seeds.
449
The legislation also required the Secretary of
443. See H.R. Rep. No. 114-208, at 11 (2015) (“[The Act will] ensure national
uniformity regarding labeling of foods derived from genetically engineered plants by
preventing a patchwork of conflicting State or local labeling laws which inherently interfere
with interstate and foreign commerce.”).
444. See id. at 12 (detailing a letter written to Vermont Governor Peter Shumlin from a
food industry trade association explaining the massive potential costs of Act 120).
445. See id. at 14 (describing the Committee’s intent to continue the voluntary
consultation process established by the 1992 FDA Statement of Policy).
446. See id. (asserting that the Committee intended to recognize the FDA 1992
Statement of Policy and to reinforce its purpose to provide everyone with the assurance that
foods regulated under the Policy are “as safe to eat as non-genetically engineered foods”).
447. See id. at 17 (outlining the Committee’s solution to the desires of some consumers
to know, via food product labeling, whether they are buying or eating food produced with
genetic engineering).
448. Id. at 18 (stating the Committee’s intent for this solution to be the single standard
for food claims concerning genetic engineering).
449. Id. at 18 (setting forth what types of claims were included in this framework).
2017] GMO LABELING IN THE US AND EU 703
Agriculture to establish national standards for labeling non-GE
foods.
450
Very specific procedures to apply for non-GMO and GMO
certification were also listed in the bill.
451
As previously mentioned, this bill was passed in the House in
July of 2015 in direct response to the state labeling laws passed in
Maine, Vermont, and Connecticut, and would therefore have made
such laws illegal as preempted by federal law.
452
In addition to
prohibiting state laws requiring GMO labeling, this bill clearly
solidified the 1992 FDA Statement of Policy.
453
This would have
given the findings of the FDA much more legal power and deference
than they currently have as a policy statement.
454
9. S. 764 and the Nationalization of GMO Labeling Requirements in
the United States
When President Obama did not pass H.R. 1599 as part of a
spending bill at the beginning of 2016, many GMO labeling
advocates celebrated as the state laws of Vermont, Maine, and
Connecticut survived federal preemption.
455
However, this celebration
would be short-lived, as President Obama signed S.764 into law on
450. Id.
451. See generally id. at 20 (describing AMA Sec. 291C. which sets forth national
standards for labeling genetically engineered food).
452. See supra notes at 437-40 and accompanying text (explaining how no state GMO
labeling laws could be established unless the government departed from the 1992 FDA
Statement of Policy and found that GMOs present a material difference from their traditional
counterparts); Jenny Hopkinson, GMO Labeling Bill Would Trump States, P
OLITICO (Apr. 9,
2014, 4:57 PM), http://www.politico.com/story/2014/04/gmo-labeling-bill-105548 (explaining
how H.R. 1599 affects state efforts to label GMOs).
453. See supra notes 445-46 and accompanying text (upholding the 1992 FDA Statement
of Policy).
454. See supra notes 445-46 and accompanying text (examining how H.R. 1599 is meant
to recognize and uphold the 1992 FDA Statement of Policy).
455. See Congress Keeps Anti-GMO Labeling Rider Out of Spending Bill, E
COWATCH
(Dec. 16, 2015, 10:59 AM), http://www.ecowatch.com/congress-keeps-anti-gmo-labeling-
rider-out-of-spending-bill-1882130060.html (discussing how the Senate Congress did not
include H.R. 1599 in the spending bill at the end of 2015, preventing the preemption of state
GMO labeling laws); Karlene Lukovitz, GMO Labeling Rider Left Out Of Omnibus Spending
Bill,
MEDIADAILY (Dec. 16, 2015, 7:21 PM), http://www.mediapost.com/ publications/article/
264945/gmo-labeling-rider-left-out-of-omnibus-spending-bi.html (highlighting discussing two
statements in the reaction to the failure of some to get H.R. 1599 not being included in the
spending bill).
704 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
July 29, 2016 and implemented a federal GMO labeling system that
eliminated any state law that mandated GMO labeling, including
those discussed in this Note.
456
The reaction to this federal legislation
was mixed, as many praised the federal legislation for implementing
the first mandatory GMO labeling system in the United States, while
others highlighted defects that supposedly allow companies to avoid
clearly labeling their food as genetically modified.
457
Despite the
diverse opinions about this federal regulation, it is clear that the state
labeling laws of Connecticut, Maine, and Vermont and the general
state movement towards GMO labeling laws made a severe impact on
the US Congress and President, as these measures prompted the
federal government to shift from a voluntary GMO labeling
framework under H.R. 1599 to a mandatory GMO labeling regime
that responded to public outcry for greater transparency about genetic
engineering.
458
Known as S. 764, the new federal regulation establishes a
national disclosure standard for bioengineered foods.
459
Bio-
engineering is defined as food that “contains genetic material that has
been modified through in vitro recombinant deoxyribonucleic acid
(DNA) techniques” and “for which modification could not otherwise
be obtained through conventional breeding or found in nature.”
460
The
456. See Mary Clare Jalonick, Obama Signs Bill Requiring Labeling of GMO Foods, AP
(July 29, 2016, 6:07 PM), http://bigstory.ap.org/article/65c61c63e3df4 b74bb90a
2187122d744/obama-signs-bill-requiring-labeling-gmo-foods (reporting that President Obama
signed a bill into law requiring genetically modified ingredients to be labeled for the first
time); Jason J. Kim & Andrew J. Peterson, President Obama Signs Bill That Will Establish
Federal GMO Labeling Standards, L
EXOLOGY (Aug. 4, 2016), http://www.
lexology.com/library/detail.aspx?g=bb672dd0-b232-45c4-a876-e163ee66a849 (describing
how the federal GMO labeling standards stating that the law preempts state laws that
“mandate the disclosure of GMO ingredients on product packaging”).
457. See Agri-Pulse Communications, Obama Signs Historic GMO Labeling Bill,
A
GRICULTURE.COM (July 29, 2016), http://www.agriculture.com/news/crops/obama-signs-
historic-gmo-labeling-bill (discussing the opinions of those who supporters of the federal law);
Stephen Dinan, Obama Signs Bill Overturning Vermont’s GMO Labeling Law, W
ASH. TIMES
(Aug. 2, 2016), http://www.washingtontimes.com/news/2016/aug/2/obama-signs-bill-over
turning-vermonts-gmo-labeling/ (explaining the extreme opposition towards the new federal
legislation).
458. See supra Sections II.A.3-4, 6, 8 (giving an overview of the state movement and the
response of the US federal government).
459. See generally 7 U.S.C. § 1639 (2016).
460. See id. §§ 1639(1)(A-B).
2017] GMO LABELING IN THE US AND EU 705
bill charges the Secretary of Agriculture to establish a national
mandatory bioengineered food disclosure standard governing any
bioengineered food and any food that may be bioengineered.
461
It
further instructs the Secretary of Agriculture to establish requirements
and procedures that the Secretary deems necessary to carry out that
standard within two years of the date of enactment.
462
As part of this
charge, the Secretary must determine “the amounts of a bioengineered
substance that may be present in food, as appropriate, in order for the
food to be a bioengineered food.”
463
Furthermore, a bioengineered
food will not be treated as safer than, or not as safe as, a non-
bioengineered counterpart of the food solely because that food is
bioengineered or is produced or developed using bioengineering, so
long as the food has successfully finished the premarket federal
regulatory review process.
464
Thus, the federal regulation of
bioengineered foods will depend on the end product, and not solely on
the process of genetic engineering used in production of the food.
465
The bill also prevents food derived from animals from being
considered bioengineered food solely because the animals consumed
feed that was produced from, contained, or consisted of a
bioengineered substance.
466
Finally, the bill excludes very small food
manufacturers and food served in a restaurant or similar retail food
establishment.
467
The bill also gives specific requirements for the labeling of such
bioengineered foods and provides three options for compliance.
468
Food manufacturers may use text, a symbol, or an electronic or digital
link to disclose the bioengineered status of their food.
469
On-package
language must accompany an electronic or digital link disclosure that
demonstrates that the link will provide access to the information by
stating “scan here for more food information” or other language that
461. See id. § 1639(a).
462. See id. §§ 1639(a)(1-2).
463. See id. § 1639(b)(2)(B).
464. See id. § 1639(b)(3).
465. See id.
466. See id. § 1639(b)(2)(A).
467. See id. § 1639(b)(2)(G).
468. See id. § 1639(b)(2)(D).
469. See id.
706 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
only reflects technological changes.
470
A telephone number that
provides access to the disclosure must also be included with the
electronic or digital link disclosure and such electronic or digital link
disclosure must be of sufficient size to be effectively and easily read
or scanned by a digital device.
471
Furthermore, the electronic or
digital link cannot have marketing or promotional information and
must provide the disclosure on the first product information page that
appears for the product on a mobile device, website, or other landing
page.
472
Consumer privacy is protected, as the electronic or digital
link disclosure may not analyze, sell, or collect any personally
identifiable information about consumers or their devices.
473
If such
information is necessary to comply with the regulation, it may not be
used for any other purposes and must be deleted immediately.
474
The Secretary must provide alternative reasonable disclosure
options for food contained in small or very small packages.
475
Small
manufacturers will have the option of choosing from additional on-
package options, which are a telephone number “accompanied by
appropriate language to indicate that the phone number provides
access to additional information” and a website that is maintained by
the manufacturer in a manner consistent with section (d) as
appropriate.
476
Any telephone number disclosure must only state “call
for more food information.”
477
There is a record-keeping requirement under S. 764, as each
person that is subject to the mandatory disclosure requirement must
maintain any records that the Secretary determines to be customary or
reasonable in the food industry to establish compliance with the
law.
478
These records must also be available to the Secretary upon
470. See id. § 1639(d)(1)(A).
471. See id. §§ 1639(d)(4-5).
472. See id. § 1639(d)(2).
473. See id. § 1639(d)(3)(A).
474. See id. § 1639(d)(3)(B).
475. See id. § 1639(b)(2)(E).
476. See id. § 1639(b)(2)(F)(ii).
477. See id. § 1639(d)(1)(B).
478. See id. § 1639(g)(2).
2017] GMO LABELING IN THE US AND EU 707
request.
479
The Secretary is also empowered to conduct an audit,
examination, or similar activity to review any required records.
480
According to S. 764, the Secretary must conduct a study to
identify possible technological challenges that may impact consumers
accessing the bioengineering disclosure through digital or electronic
methods under the regulation.
481
As part of this study, the Secretary
must consider public comments and certain factors on consumer
access, including the availability of wireless Internet or cellular
networks, challenges facing smaller retailers and rural retailers, and
the costs and benefits of installing electronic or digital link scanners
or other evolving technology that provide bioengineering disclosure
information in retail stores.
482
If the Secretary finds through this study
that consumers would not have sufficient access to the bioengineering
information through electronic or digital methods while shopping, the
Secretary must consult with food manufacturers and retailers before
providing additional and comparable options to access the
bioengineering disclosure.
483
This federal regulation is meant to be the sole source of GMO
labeling requirements, as shown by the explicit prohibition of state
GMO labeling laws.
484
According to the law, no state may establish or
continue in effect any requirement relating to the labeling or
disclosure of whether any food involved in interstate commerce is
bioengineered, developed, or produced using bioengineering for a
food that is subject of the national bioengineered food disclosure
unless such requirement is identical to the mandatory disclosure
requirement under S. 764.
485
Under the heading of federal
preemption, states are prohibited from establishing any requirement
for food or seed in interstate commerce relating to the labeling of
“whether a food (including food served in a restaurant or similar
establishment) or seed is genetically engineered (which shall include
such other similar terms as determined by the Secretary of
479. See id.
480. See id. § 1639(g)(3)(A).
481. See id. § 1639(c)(1).
482. See id. §§ 1639(c)(2-3).
483. See id. § 1639(c)(4).
484. See id. § 1639(e).
485. Id.
708 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
Agriculture) or was developed or produced using genetic
engineering,” which includes any requirements for claims that “a food
or seed is or contains an ingredient that was developed or produced
using genetic engineering.”
486
Finally, the law also provides information about food that is
considered non-GMO.
487
If a food is certified under the national
organic program established by the Organic Foods Production Act,
the food manufacturer may make claims regarding the absence of
bioengineering in the food, including “non-bioengineered” or “non-
GMO.”
488
However, a food may not be regarded as “non-
bioengineered” or “non-GMO” only because the food is not required
to have a disclosure that the food is bioengineered under this law.
489
10. Reaction to S.764
As previously discussed, the reaction to the new national federal
labeling standard has been mixed and much controversy surrounds the
question of whether the law actually requires GMO labeling.
490
Much
of the food industry supported S. 764 and several food organizations
voiced their opinions in the wake of the new law.
491
According to the
GMA, which vehemently opposed state GMO labeling laws, the
legislation will “‘open a new era for transparency in ingredient
information for consumers . . .’” and is a consistent national
standard that is superior to a “‘costly and confusing patchwork of
different state labeling,’” which has allegedly left consumers in the
state of Vermont with fewer products available for purchase and
486. See id. § 1639(i)(b).
487. See 7 U.S.C. § 6524 (2016).
488. Id.
489. See 7 U.S.C. § 1639(c).
490. See supra note 457 and accompanying text (highlighting some of these opinions
and controversy).
491. See Congress Passes GMO Food Labeling Bill, NBC
NEWS (July 14, 2016, 4:40
PM), http://www.nbcnews.com/health/health-news/congress-passes-gmo-food-labeling-bill-n
609571 (stating that the food industry supports the legislation); Dan Flynn, Compromise Bill
On GMO Labeling Lands On President’s Desk, F
OOD SAFETY NEWS (July 14, 2016), http://
www.foodsafetynews.com/2016/07/compromise-bill-on-gmo-labeling-lands-on-presidents-
desk/#.V-sYu8ac8UU (explaining that over 1,000 food and agricultural organizations were in
favor of S. 764 and that many of these issued press statements following the vote).
2017] GMO LABELING IN THE US AND EU 709
raised compliance costs for small businesses.
492
According to the
Organic Trade Organization, while the measure has its flaws and the
organization plans to advocate for further changes, the bill goes a long
way to increase consumer clarification and covers thousands of more
products than Vermont’s Act 120 did.
493
Despite the swelling support of the food industry, many
organizations and commentators have strictly opposed the new law
and have pointed out deficiencies that some argue allow companies to
be less forthcoming about GMOs.
494
A petition urging a veto with the
100,000 signatures necessary to earn an official response was filed
with the White House.
495
However, the White House responded after
President Obama signed the bill by discussing the bipartisan effort in
Congress to pass the legislation.
496
It is important to note that about
half of the House Democrats and half of the Senate Democratic
Caucus voted against the measure, as well as a small minority of the
GOP in both the Senate and House of Representatives.
497
492. See Agri-Pulse Communications, supra note 457; Flynn, supra note 491 (discussing
the statements made by the GMA).
493. Letter from Leadership: GMO Labeling, Organic Trade Organization (Sept. 16,
2016), https://www.ota.com/advocacy/gmos/gmo-labeling/letters-leadership-gmo-labeling;
Organic Trade Organization: Lobby Group Under Activist Fire For Supporting Federal GMO
Labeling, G
ENETIC LITERACY PROJECT (Oct. 12, 2016), https://www.geneticliteracyproject.
org/glp-facts/organic-trade-association-lobby-group-activist-fire-supporting-federal-gmo-
labeling/ (providing an analysis of the Organic Trade Association’s reaction to S. 764).
494. See Dan Charles, Congress Just Passed A GMO Labeling Bill. Nobody’s Super
Happy About It, NPR (July 14, 2016, 5:34 PM), http://www.npr.org/sections
/thesalt/2016/07/14/486060866/congress-just-passed-a-gmo-labeling-bill-nobodys-super-
happy-about-it (analyzing the broad criticism of S. 764); Brenna Houck, President Obama
Signs Controversial Bill Requiring GMO Labels, E
ATER (July 31, 2016, 2:17 PM), http://
www.eater.com/2016/7/31/12337356/us-passes-law-gmo-labels (explaining how critics claim
that the law does not go far enough).
495. See Veto the Dark Act (S. 764), W
HITE HOUSE (July 9, 2016), https://
petitions.whitehouse.gov/petition/veto-dark-act-s764; Dinan, supra note 457 (discussing this
petition).
496. See Veto the Dark Act (S. 764), supra note 495; Dinan, supra note 457 (examining
the response of the White House).
497. See Dinan, supra note 457 (giving the breakdown of the vote); Dianne Lugo, U.S.
Senate Passes GM Food Labeling Bill, S
CIENCEINSIDER (July 8, 2016, 3:45 PM),
http://www.sciencemag.org/news/2016/07/us-senate-passes-gm-food-labeling-bill (stating that
half of Senate Democrats voted against S. 764).
710 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
Many have also criticized the legislative process behind the bill,
or rather the supposed lack thereof.
498
After H.R. 1599 did not pass in
the Senate in March 2016, S. 764 was introduced to the Senate on
June 23, 2016.
499
The Senate passed the bill on July 7, 2016 and the
House of Representatives passed it on July 14, 2016.
500
Unlike
Vermont’s Act 120, which had fifty hearings and two years of debate,
the federal bill had less than a week of debate and no hearings.
501
This
lack of traditional legislative process has led some to criticize the
motives of those behind the bill and characterize legislators as
pandering to corporations, which increasingly pushed for federal
legislative action in the wake of Vermont’s Act 120 that went into
effect on July 1, 2016.
502
498. See Andrew Kimbrell, Why The GMO ‘Labeling’ Bill That Obama Just Signed Into
Law Is A Sham- And A National Embarrassment, H
UFFINGTON POST (Aug. 5, 2016, 6:13 PM),
http://www.huffingtonpost.com/andrew-kimbrell/why-the-gmo-labeling-bill_b_11335918.html
(criticizing the bill’s lack of hearings and expert testimony); Chris Morran, Congress Passes
Bill Outlawing Vermont’s GMO Labels, Replacing Them With Barcodes, C
ONSUMERIST (July
14, 2016), https://consumerist.com/2016/07/14/congress-passes-bill-outlawing-vermonts-gmo-
labels-replacing-them-with-barcodes/ (stating that the bill did no undergo the usual process of
hearings, debate, and amending and marking up in committee). Morran also explains that the
bill was fast tracked by Senate Majority Leader Mitch McConnell “by simply copy/pasting its
text into the empty shell of a bill that had already passed by the Senate, but not enacted into
law.”
499. See S. 764, 114th Cong. (2015-2016), https://www.congress.gov/bill/114th-
congress/senate-bill/764 [hereinafter S. 764 Timeline]; Tom Philpott, Congress Just Passed a
Bill to Nix GMO Labeling, M
OTHER JONES (June 27, 2016, 5:22 PM), http://www.
motherjones.com/environment/2016/06/senate-deal-would-crush-vermonts-gmo-labeling-law
(explaining how S. 764 was introduced after H.R. 1599 failed to pass the Senate in March
2016).
500. See S. 764 Timeline, supra note 499; Philpott, supra note 499 (providing a timeline
of S. 764).
501. See Jerry Hagstrom, Senate Passes GMO Label Bill, P
ROGRESSIVE FARMER (July
8, 2016, 6:27 AM), https://www.dtnpf.com/agriculture/web/ag/perspectives/blogs/ag-policy-
blog/blog-post/2016/07/08/senate-passes-gmo-label-bill (stating that Vermont’s Law had fifty
hearings, 130 witnesses, and two years of debate while the Senate bill had zero hearings and
less than a week of debate time); Kimbrell, supra note 498 (stating the no hearings were
conducted regarding S. 764).
502. See Hagstrom, supra note 501 (“[A]gricultural lobbies had come together to create
the Coalition for Safe Affordable Food specifically to preempt the Vermont Labeling law.”).
Hagstrom also noted that this group praised the action of the Senate and characterized S. 764
as a “‘common sense bipartisan legislation’ that will provide a consistent, disclosure
framework.” See also Kimbrell, supra note 498 (characterizing the measure as a product of
campaign corruption and organic industry “sellout”).
2017] GMO LABELING IN THE US AND EU 711
Some also argue that by allowing food manufacturers to use a
bar code to disclose GMO information of the food they sell, the
regulation allows companies to hide this information and makes it
more difficult for consumers to find out information about GMO
ingredients.
503
According to Food & Water Watch Executive Director
Wenonah Hauter, the options of QR codes, bar codes, or 1-800
numbers are not transparent GMO labeling methods, but are instead
“cumbersome, and elitist and above all—a giant hassle.”
504
In
addition to the supposed inconvenience of these options, many argue
they disadvantage certain groups that do not have access to
smartphones or the internet, including financially disadvantaged,
elderly, and rural consumers who cannot access the information easily
or at all.
505
Another major argument against the law is that it provides
no penalties for companies that fail to comply with the labeling
requirements.
506
The law also does not give any authority to recall
products that are not correctly labeled, which has led many to
question the law’s actual effect on companies.
507
503. See Dinan, supra note 457 (highlighting these arguments); Kimbrell, supra note 498
(stating that the use of 800 numbers and websites is another way to masquerade non-labeling).
504. See President Obama Capitulates to Big Food, Signs DARK Act Into Law, F
OOD
CONSUMER (July 29, 2016), http://www.foodconsumer.org/newsite/Politics/32/signsdark_
act_into_law_0729160901.html.
505. See Emily Monaco, 5 Major Fails of the New GMO Labeling Law, O
RGANIC
AUTHORITY (Aug. 18, 2016), http://www.organicauthority.com/5-major-fails-of-the-new-gmo-
labeling-law-and-5-ways-its-not-so-bad/ (discussing this argument); Michael Addady,
President Obama Signed This GMO Labeling Bill, F
ORTUNE (July 31, 2016, 4:49 PM), http://
fortune.com/2016/07/31/gmo-labeling-bill/ (setting forth these concerns); Richard Fama, The
New GMO Labeling Law: A Matter of Perspective, F
OOD SAFETY NEWS (Sept. 8, 2016),
http://www.foodsafetynews.com/2016/09/the-new-gmo-labeling-law-a-matter-of-
perspective/#.V-diRsac8UU; Kimbrell, supra note 498 (highlighting these issues).
506. See Phil Lempert, Sorry Food Industry, The Historic GMO Food Labeling Bill is
Anything But, F
ORBES (Aug. 1, 2016, 1:24 PM), http://www.forbes.com/sites/phillempert/
2016/08/01/sorry-food-industry-the-historic-gmo-food-labeling-bill-is-anything-
but/#2beb2db85e39 (detailing this objection); The Latest: Sanders Says GMO Bill In Congress
Has Loopholes, A
SSOCIATED PRESS (July 1, 2016, 1:47 PM), http://bigstory.ap.org/article/
cf1e9f6cc9a543bea10f9aaadbcbd266/latest-governor-urges-tweets-vermont-gmo-label-law
(explaining Senator Sander’s opposition to S. 764 and the lack of penalties for companies who
violate the law).
507. See Lempert, supra note 506 (highlighting this inability); Riette van Laack &
Ricardo Carvajal, GMO Labeling Bill Is A Pen Stroke Away From Becoming Law: What
Comes Next?, FDA
LAW BLOG (July 19, 2016), http://www.fdalawblog.net/fda_law_
blog_hyman_phelps/2016/07/gmo-labeling-bill-is-a-pen-stroke-away-from-becoming-law-
712 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
Many also criticize the law as failing to establish measures as
strong as the standard under Vermont’s Act 120, which went into
effect on July 1, 2016.
508
Others also oppose the federal preemption of
state GMO labeling laws.
509
While there was question of whether
Vermont would sue the federal government if the law was passed, the
Vermont Attorney General announced on August 2, 2016 that it
would no longer enforce Act 120.
510
As part of this announcement,
the Vermont Attorney General’s office also stated its intention to
“take an active role advocating for the federal regulations to give
consumers the same access to information, in plain English, that they
had under Vermont’s law.”
511
Perhaps one of the most interesting responses to the federal
standard comes from the FDA, which has questioned the law’s scope
and has flagged potential conflicts with the agency’s own
regulations.
512
In its comments to provide technical assistance on the
draft bill, the FDA stated that the bill would give the USDA authority
over food labeling that is “otherwise under FDA’s sole regulatory
jurisdiction.”
513
The FDA reiterated its “long-held policy position” on
the safety concerns of GMOs and how it has previously not wanted to
what-comes-next.html (stating that the bill makes it evident that there is no authority for the
USDA to recall a food that does not bear a required disclosure).
508. See Sanders Vows to Defend Vermont’s GMO Labeling Law, S
ANDERS, http://
www.sanders.senate.gov/newsroom/press-releases/sanders-vows-to-defend-vermonts-gmo-
labeling-law (last visited Jan. 13, 2017) (providing Senator Sander’s opposition to the federal
legislation); Lempert, supra note 506 (stating that Vermont’s law contained much stricter
labeling requirements than S. 764 does).
509. See Emily Monaco, New GMO Labeling Bill May Preempt Vermont’s More
Stringent Law, O
RGANIC AUTHORITY (June 29, 2016), http://www.organicauthority.com/new-
gmo-labeling-bill-preempt-vermonts-law (discussing this criticism of S. 764). See generally
Brad Plumer, The Controversial GMO Labeling Bill That Just Passed Congress, Explained,
V
OX (July 14, 2016, 3:08 PM), http://www.vox.com/2016/7/7/12111346/gmo-labeling-bill-
congress (discussing the role of Vermont’s state law in the implementation of S. 764).
510.
As of August 2, 2016, Attorney General No Longer Enforcing Act 120, OFF. ATT’Y
GENERAL, http://ago.vermont.gov/hot-topics/ge-food-litigation.php (setting forth the decision
of Vermont’s Attorney General).
511.
Id.
512. See FDA/HHS Technical Assistance on Senate Agriculture Committee Draft
Legislation To Establish A National Disclosure Standard For Bioengineered Foods
(EDW16734) (June 27, 2016), available at http://src.bna.com/gnD [hereinafter FDA
Comments On S. 764].
513. See FDA Comments On S. 764, supra note 512 (discussing the agency’s
disagreement with this assignment).
2017] GMO LABELING IN THE US AND EU 713
be responsible for a regulatory program governing labeling of foods
as bioengineered, as the public might consider it to be a reflection on
the safety of such foods.
514
The FDA expressed how the option of
providing disclosures electronically is in tension with the FDA’s
statute and regulations requiring disclosures on food labels.
515
Most
importantly, the FDA stated that the definition of “bioengineering”
would result in a “somewhat narrow cope of coverage” and explained
that the phrase “that contains genetic material” will exclude many
foods from GE sources from labeling requirements, such as oil made
from GE soy, starches, and purified proteins.
516
The scope of
coverage to foods where the genetic modification “could not
otherwise be obtained through conventional breeding or found in
nature” would be difficult to show.
517
As just demonstrated, there are several contrasting views of S.
764 and the federal preemption of state GMO labeling laws.
518
While
there is a wide range of opinions on these issues, one idea remains
undeniable: the United States has seen a dramatic shift in GMO
regulatory policy as a result of the state movement towards GMO
labeling.
519
This causal relationship greatly mirrors the
implementation of mandatory GMO labeling requirements in the
European Union as result of Member State action that brought about
the 1997 EU crisis, which is discussed below in Part Section II.B.
520
B. EU Opposition to GMOs
This Section will describe how the European Union faced public
opposition similar to what the United States has experienced
514. See FDA Comments On S. 764, supra note 512 (explaining and reiterating the
FDA’s policy on GMOs under the 1992 FDA Statement of Policy).
515. See FDA Comments On S. 764, supra note 512 (setting forth some of the agency’s
objections to the disclosure methods under S. 764).
516. See FDA Comments on S. 764, supra note 512 (highlighting one of the biggest
concerns about S. 764 with regards to this definition).
517. See FDA Comments on S. 764, supra note 512 (discussing the complications with
the application of S. 764).
518. See supra notes 490-517 and accompanying text (providing an overview of some of
these views).
519. See supra Sections I.A, II.A (explaining the history of GMO labeling in the United
States).
520. See infra Section II.B (providing an overview of the 1997 EU crisis).
714 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
concerning GMO labeling. Section I.B.1 will describe the labeling
requirements before the crisis in the European Union and what led to
public unrest about GMO labeling while Section I.B.2 will detail the
actual crisis. Section I.B.3 will explain the reform of the labeling
regime through the 2001 Deliberate Release Directive and the
Traceability and Labeling Regulation.
While the European Union has a much stricter GMO labeling
regime than the United States, it has faced and still faces public
opposition to its policies that call for even greater restrictions on the
cultivation of GMOs and the use of these genetically engineered
products on the market.
521
As discussed in Part I of this Note, the
precautionary principle is the foundation of the EU GMO regulatory
system and thus the regulation of GMOs is based on a detailed risk
assessment system that relies on current scientific evidence and
independent assessments.
522
While this detailed system has a main
objective of protecting human health and the environment, the EU
public still distrusts GMOs in general, including those that have been
approved under the current regulatory system.
523
And while the
European Union has moved to a more streamlined approach to GMO
approval since the 1998 de facto moratorium on GMOs, public
opinion has not followed this shift and continues to oppose GMOs
vehemently across the board.
524
521. See generally supra Sections I.A-B (explaining the stark differences between the
two regulatory systems); see also infra note 524 (highlighting the request of Member States to
ban cultivation of GMOs in their territories).
522. See generally supra Section I.B. (explaining the precautionary principle and the risk
assessment procedures in the EU regulatory system).
523. See Wilinska, supra note 19, at 155-56 (explaining how European consumers are
extremely skeptical of GM foods and exhibit a lack of trust in their governments’ food safety
regulations); Sella-Villa, supra note 294, at 973 (stating that as opposed to US citizens,
Europeans are deeply skeptical about GMO’s environmental impact and do not trust
government food regulations since the 1990s Mad Cow scare).
524. See Federici, supra note 39, at 542 (describing how a majority of Europeans do not
support GM foods, as they are not considered useful but risky to society, even after much
stricter regulations have been imposed on GMOs in the European Union); Wilinska, supra
note 20, at 155 (stating that genetic research and development of GM foods have been at the
center of hot debate and vehement resistance in Europe).
2017] GMO LABELING IN THE US AND EU 715
1. Labeling Requirements in the European Union Before the 1998 De
Facto Moratorium on GMOs and the 1997 EU Crisis
Public opinion has been a strong factor in EU GMO regulation
and has greatly influenced the European Union’s mandatory labeling
regime.
525
As discussed in Part I of this Note, there was a de facto
moratorium on GMOs being cultivated or approved in the European
Union, which led to an international dispute at the WTO.
526
Before
this de facto moratorium occurred, the European Union did not
require labeling of GMOs and did not require manufacturers to
include a plan for labeling in their approval applications.
527
Due to the
lack of a labeling regime, a crisis erupted in the European Union
when Bt-maize was approved without any labeling requirements and
was set to enter the EU market without any indication that it
contained the approved GMO.
528
As previously discussed, GMO
regulation went through a series of reforms and changes as a result of
this crisis, including the introduction of a more streamlined approach
that focuses heavily on independent risk assessment conducted by the
EFSA and input from the Member States.
529
525. See generally Wilinska, supra note 19, at 541-46 (giving an overview of the way in
which public opinion in the European Union concerning GMOs has greatly influenced the
regulation of such products); Sella-Villa, supra note 294, at 973-74 (detailing how the
differences between the legal regimes of the United States and European Union with respect to
GMOs reflect different social and cultural approaches to GMOs).
526. See generally supra Section I.B. (discussing the de facto moratorium).
527. See 1990 Deliberate Release Directive, supra note 150, art. 11, at 1 (detailing how
a notifier “may propose not to comply” with one or more of the requirements of Annex III B,
which set out the requirements for a proposal of labeling and packaging, if the notifier
considered either on the basis of the results of any release notified under Part B of the
Directive or on substantive reasoned scientific ground that the placing on the market and use
of the product did not pose a risk to the environment or human health); see also Stewart &
Johanson, supra note 243, at 258 (describing how there was no labeling requirement under
1990 Deliberate Release Directive, since notifying parties could propose not to comply to the
requirements of Annex III.B, which set forth rules for labeling).
528. See Stewart & Johanson, supra note 243, at 260-78 (giving a detailed explanation of
the crisis that took place in the European Union and its roots in the controversial approval of
Bt-maize in 1997); see also Mereu, supra note 182, at 206 (describing the problems resulting
from the approval of Bt-maize over the objection of most Member States and the de facto
moratorium stemming from the Member States’ reliance on the Safeguard Clause of the 1990
Deliberate Release Directive and desire for transparency and traceability).
529. See generally supra Section I.B. (explaining these reforms).
716 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
Part of this reform included an expansion of subject matter
covered by the regulation.
530
Under the 1990 Deliberate Release
Directive, the development of GM crops and placing of live GMOs
including fruit, seeds, and other products “containing viable GMOs”
were included in the Directive because it specifically applied to raw
materials.
531
However, this did not include processed products that
contained GMOs.
532
This narrow application ceased under the Novel
Foods Regulation, which regulated novel foods and novel food
ingredients.
533
According to the Novel Foods Regulation, novel foods
included foods containing GMOs that were further processed and
were the finished products that consumers bought in stores.
534
Specifically, novel foods were foods that “had not been used for
human consumption to a significant degree within the Community
before May 1997” and fell into one of six categories.
535
This
sometimes made it difficult for manufacturers to determine if their
products were included in the Regulation and were thus required to
obtain premarket authorization.
536
530. See generally Federici, supra note 39, at 543-46 (highlighting the scope of the
reform, specifically regarding GMO labeling); Sella-Villa, supra note 294, at 982-91
(explaining the changes in the EU regulatory system from the 1990s through 2003).
531. See Stewart & Johanson, supra note 243, at 256 (discussing the 1990 Deliberate
Release Directive as “[concerning] the placing in the market of GMO products that may be
described as raw materials”); Hilary Ross, Genetically Modified Food: The EU Regulatory
“Maize”, 18 N
AT. RESOURCES & ENV’T. 9, 9 (2003-2004) (discussing the types of GMOs that
were covered under the 1990 Deliberate Release Directive).
532. See Ross, supra note 531, at 9 (explaining the 1990 Deliberate Release Directive’s
failure to regulate processed products containing GMOs as the Directive’s “major failing”);
see also Stewart & Johanson, supra note 243, at 256 (distinguishing raw foods, which were
covered by the 1990 Deliberate Release Directive, from novel foods, which would be covered
under a separate Regulation).
533. See Novel Foods Regulation, supra note 197; see also D
EBRA HOLLAND & HELEN
POPE, EU FOOD LAW AND POLICY 112 (2004) (explaining the Novel Foods Regulation).
534. See Stewart & Johanson, supra note 243, at 256 (explaining novel foods and how
they compare to raw foods). See generally Ross, supra note 531, at 9 (introducing the Novel
Foods Regulation).
535. Ross, supra note 531, at 9 (defining novel foods and describing the category system
under the Novel Foods Regulation); Novel Foods Regulation, supra note 197, art. 1, at 2
(stating what the Regulation applies to and the six categories).
536. See Ross, supra note 531, at 10 (highlighting a difficulty faced by manufacturers
under the Novel Foods Regulation). See generally G
ERALD C. NELSON, GENETICALLY
MODIFIED ORGANISMS IN AGRICULTURE: ECONOMICS AND POLITICS 112 (2001) (discussing
market uncertainty that resulted from the Novel Foods Regulation).
2017] GMO LABELING IN THE US AND EU 717
As part of the Novel Foods Regulation, manufacturers of novel
foods were required to have their goods authorized before bringing
them to market and the Regulation mandated labeling for novel foods
or food ingredients if they fit certain requirements.
537
Under the Novel
Foods Regulation, novel foods or food ingredients had to be labeled if
(1) they were no longer equivalent to a conventional food or
ingredient, (2) raised health implications for certain sections of the
population, (3) contained material which gave rise to ethical concerns,
or (4) contained live GMOs.
538
If a manufacturer determined that his
product had not been used for human consumption to a significant
degree before May 15, 1997 and that it fell into one of the six
categories found in Article 1, he then had to apply for premarket
approval and fulfill labeling requirements as part of the application.
539
For any characteristics of a food that made it no longer equivalent to a
conventional food or ingredient, the label had to give details to inform
consumers of such characteristics.
540
One of the main deficiencies of
this labeling requirement was that since it did not include specific
guidelines, but rather gave general principles, there was not a set
framework to use in order to determine if a product required labeling
under the Regulation.
541
A second problem was that it was not
retroactive and thus only applied to “novel foods” that were seeking
market approval after May 1997.
542
537. See generally Novel Foods Regulation, supra note 197 (applying rules and
requirements to manufacturers of novel foods).
538. See id. art. 8, at 1 (setting forth the requirements for labeling).
539. See id. art. 1, at 2 (providing the six categories to which this regulation applied);
Ross, supra note 531, at 10 (discussing the requirements under the Novel Foods Regulation).
540. See Novel Foods Regulation, supra note 197, art. 8, at 1 (detailing how a product
had to be labeled in this situation); Ross, supra note 531, at 10 (giving the requirements
regarding these characteristics).
541. See H
OLLAND & POPE, supra note 533, at 113 (stating that since the provisions
were only general principles, it was extremely difficult to predict whether they would apply in
practice); Ross, supra note 531, at 9-10 (explaining some of the complications with the Novel
Foods Regulation, such as manufacturer confusion).
542. See H
OLLAND & POPE, supra note 533, at 112-13 (stating that this regulation only
applied to foods that were not used to a significant degree before May 1997); Ross, supra note
531, at 10 (discussing the May 15, 1997 date).
718 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
2. A Temporary Solution to the 1997 European Union Crisis
While the implementation of the Novel Foods Regulation
attempted to allay the fears of the public, consumers were still
concerned with GMO products that had been authorized under the
1990 Deliberate Release Directive that were not under this labeling
requirement since the Novel Foods Regulation was not retroactive.
543
Thus, Regulation 259/97, which took effect as of January 27, 1997,
did little to avoid the crisis that occurred as a result of the
Commission’s approval of Bt-maize, which granted France the
authority to place Ciba-Geigy’s GMO maize on the market without a
labeling requirement since the product did not “present safety
concerns.”
544
As discussed in Part I of this Note, Austria and
Luxembourg banned Bt-maize from their territories based on Article
16 of the 1990 Deliberate Release Directive, which allowed Member
States to ban an approved GMO if they had justifiable reasons to
believe that the product might adversely affect human health or the
environment.
545
In addition to the Novel Foods Regulation, other
regulatory changes were attempted in order to rectify the situation and
to quench the public’s desire for GMO labeling.
546
On April 2, 1997,
the Commission proposed to amend the 1990 Deliberate Release
Directive so that products that contained or may have contained
GMOs would be labeled.
547
While this was not the permanent solution
543. See Ross, supra note 531, at 10 (stating that the Novel Foods Regulation was not
retrospective in its application); Sella-Villa, supra note 294, at 983 (explaining how this
regulation defined “novel foods” as foods and ingredients that had not been used for human
consumption to a significant degree within the Community before May 15, 1997).
544. See Stewart & Johanson, supra note 243, at 263 (discussing the authorization of Bt-
maize and the rationale behind the lack of mandatory labeling of the product); Ross, supra
note 531, at 9-11 (explaining how the crisis still occurred despite efforts to calm public unrest
through these measures).
545. See generally supra Section I.B (explaining the Member State response to the
approval of Bt-maize); Stewart & Johanson, supra note 243, at 267 (discussing the Member
State reaction to the authorization of Bt-maize).
546. See Stewart & Johanson, supra note 243, at 269 (explaining these attempted
measures and their purposes). See generally Ross, supra note 531, at 10 (giving an overview of
the attempts to settle the public dissent).
547. See European Commission Press Release, IP/97/259, The European Commission
Has Decided to Propose Further Labelling of Genetically Modified Organisms (Apr. 2, 1997)
(proposing to amend the 1990 Deliberate Release Directive); Stewart & Johanson, supra note
243, at 269 (discussing this proposal).
2017] GMO LABELING IN THE US AND EU 719
to the labeling issue in the European Union, it was a transitional
repair that was made in anticipation of the Commission’s review of
the 1990 Deliberate Release Directive.
548
The main reason behind this
change was the Member State demand for labeling, as most Member
States objected to placing Bt-maize on the market without labeling.
549
Another reason was the clear stance that Austria and Luxembourg
took in banning the approved product, as they too demanded labeling,
in addition to further regulation of GMO products.
550
The Regulatory Committee approved the Commission’s proposal
to amend the 1990 Deliberate Release Directive on May 29, 1997 and
the Commission adopted the labeling amendment, the 1997 Adapting
Directive, on June 18, 1997.
551
Under this new Directive, Member
States had to conform to the decision by July 31, 1997.
552
Products
that contained GMOs now required labeling and when GMO products
were mixed with non-GMO products, the label had to indicate that
genetically modified organisms “may be present.”
553
A crucial part of this Directive is the way in which it was
adopted.
554
Because of the crisis in the European Union, the
Commission decided to act quickly in order to calm public outrage
over the authorization of GMOs such as Bt-maize and to bring
548. See Stewart & Johanson, supra note 243, at 268 (discussing this temporary
solution). See generally Ross, supra note 531, at 10 (explaining one of the temporary solutions
to the unrest of the EU public).
549. See Stewart & Johanson, supra note 243, at 268-69 (“[A]ccording to Ritt
Bjerregaard, the European Union’s Environmental Commissioner, the strong support of the
Member States for labeling was a major impetus behind the Commission’s decision.”); Nelson,
supra note 536, at 112 (stating that shortly after Bt-maize was approved by the Commission,
the 1990 Deliberate Release Directive was amended by the 1997 Adapting Directive to require
labeling products that contained or may have contained GMOs).
550. See Stewart & Johanson, supra note 243, at 268-69 (discussing these demands). See
generally Nelson, supra note 536, at 112 (stating that the Commission amended the 1990
Deliberate Release Directive to mandate GMO labeling).
551. See Stewart & Johanson, supra note 243, at 270 (explaining the directive); G
ERALD
C. NELSON, GENETICALLY MODIFIED ORGANISMS IN AGRICULTURE: ECONOMICS AND
POLITICS 112 (2001); Nelson, supra note 536, at 112 (explaining 1997 Adapting Directive).
552. See 1997 Adapting Directive, supra note 290, art. 2 (giving this deadline).
553. See id. Annex III (C) (setting these requirements); Stewart & Johanson, supra note
243, at 270-71 (discussing the changes under the 1997 Adapting Directive).
554. See Patrick Chalmers, EU Gene-Produce Label Rules Possible Within Weeks Plans
Mandatory GMO Labeling, R
EUTERS (Mar. 21, 1997) (covering the sudden movement
towards reform); Stewart & Johanson, supra note 243, at 270 (explaining the special way in
which the directive was adopted).
720 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
consistency back to GMO regulation.
555
Specifically, the Commission
was concerned that the Member States’ refusal to adopt its decision
concerning Bt-maize frustrated the purpose of the 1990 Deliberate
Release Directive and would lead to a total halt to authorization of
GMOs (which it did during the de facto moratorium on GMOs from
1998-2004).
556
To amend the 1990 Deliberate Release Directive, the
Commission proposed a “fast track” to make it a technical process
that would eliminate the involvement of the Council and the
Parliament.
557
This process would only require the Commission’s and
Regulatory Committee’s approval, which would allow the amendment
to be adopted within weeks, as opposed to between a year or two
under the traditional process.
558
It was through this fast track approach
that the Commission adopted the 1997 Adapting Directive and
mandated GMO labeling.
559
While the Directive could not be
retroactive, as this is not within the Commission’s authority, most
companies that had submitted notifications voluntarily agreed to label
their products to indicate that they contained GMOs.
560
3. GMO Labeling Reform Through The 2001 Deliberate Release
Directive and the Traceability and Labeling Regulation
As previously discussed, the 1997 Adapting Directive was only a
temporary solution to settle the 1997 crisis in the European Union that
led to the de facto moratorium, which lasted until 2004.
561
As early as
555. See Stewart & Johanson, supra note 243, at 270 (discussing this method);
Chalmers, supra note 554 (covering the sudden movement towards reform).
556. See Stewart & Johanson, supra note 243, at 269 (discussing the motivation behind
the Commission’s actions); Ross, supra note 531, at 10-11 (describing that no efforts worked
to prevent the de facto moratorium in 1998).
557. See Stewart & Johanson, supra note 243, at 269-70 (detailing this method).
558. See Stewart & Johanson, supra note 243, at 270 (explaining how the Commission
expedited the process). See generally Chalmers, supra note 554 (discussing the process).
559. See European Commission Press Release, IP 97/528, EU Commission Press
Release on GMO Labeling (June 18, 1997) [hereinafter Commission Press Release, IP
97/528]; Stewart & Johanson, supra note 243, at 270-71 (stating that the Commission used this
fast-track process to adopt the Novel Foods Regulation).
560. See Commission Press Release, IP 97/528, supra note 559; Stewart & Johanson,
supra note 243, at 271 (stating that most companies agreed to comply with the directive).
561. See Ross, supra note 531, at 10-11 (stating that nothing prevented the de facto
moratorium that took place in 1998); Stewart & Johanson, supra note 243, at 268 (explaining
how this was a temporary solution); Mereu, supra note 182, at 206 (describing the de facto
moratorium).
2017] GMO LABELING IN THE US AND EU 721
1996, the Commission was anticipating a review of the 1990
Deliberate Release Directive, which ultimately resulted in the
formation of the current GMO regime in the European Union under
the Genetically Modified Food and Feed Regulation and the
Traceability and Labeling Regulation.
562
First came the 2001
Deliberate Release Directive, which sought to resolve consumer
concerns about GMOs and was an attempt to solve the problems of
the 1990 Deliberate Release Directive, placing greater emphasis on
the precautionary principle and a case-by-case analysis of each
proposed product.
563
Furthermore, the 2001 Deliberate Release
Directive clearly required that any application must give the proposed
packaging of the product, including a section of the label or an
accompanying document that clearly states that the product contains
genetically modified organisms.
564
Though the 2001 Deliberate Release Directive was a much more
detailed and clear set of requirements concerning the approval and
labeling of GMO products, it was not until the Traceability and
Labeling Regulation amended the 2001 Deliberate Release Directive
that a threshold requirement was set for labeling GMO food
products.
565
Even though the labeling requirements were largely
brought about due to public dissent, these further requirements under
the Traceability and Labeling Regulation were also meant to ensure
562. See Stewart & Johanson, supra note 243, at 268 (explaining how the Commission
anticipated adding a GMO labeling provision to the 1990 Deliberate Release Directive);
M
ACMAOLAIN, supra note 334, at 246 (discussing the 1990 Deliberate Release Directive).
563. See M
ACMAOLAIN, supra note 334, at 246 (analyzing the shift from the 1990
Deliberate Release Directive to the 2001 Deliberate Release Directive and how the 2001
Deliberate Release Directive was “largely moulded by a vastly increased consideration for
consumer concern”); see also Carrau, supra note 21, at 1181 (explaining that a moratorium
occurred because the 1990 Deliberate Release Directive was not sufficient to assure
confidence among citizens in the European Union).
564. See 2001 Deliberate Release Directive, supra note 151, art. 13, at 2(f) (stating the
application requirements for labeling); M
ACMAOLAIN, supra note 334, at 247 (summarizing
the labeling requirements under the directive’s premarket approval process).
565. See M
ACMAOLAIN, supra note 334, at 250-51 (giving an overview of the
traceability requirements under the Traceability and Labeling Regulation, including the
threshold level); Sella-Villa, supra note 294, at 990 (explaining how the Traceability and
Labeling Regulation set a threshold standard in order to enhance traceability).
722 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
further traceability and to promote the precautionary principle.
566
Specifically, the justifications for these new traceability requirements
were to facilitate the removal of products whose unforeseen negative
effects on human health, animal health, and the environment are
established, and to also allow for the implementation of other
precautionary risk management measures when necessary.
567
This
traceability is twofold, as it mainly allows for unsafe GMO products
to be efficiently removed from the market by allowing food operators
to identify who supplied the product and which other businesses have
been supplied with the product by the same source.
568
Also, the
traceability requirements permit consumers to receive accurate
information about the foods they are eating, as the food is able to be
tracked in all stages of production, processing, and distribution.
569
Specifically, the Regulation states that this accurate information
should be made available to operators and consumers to allow them to
use their freedom of choice in an effective manner.
570
In order to ensure traceability, Article 4 of the Traceability and
Labeling Regulation requires traceability at the first stage of placing a
product consisting of or containing GMOs on the market.
571
The
operator that is sending the product to another operator must state in
566. See MACMAOLAIN, supra note 334, at 250 (explaining the purposes of the
Traceability and Labeling Regulation); Traceability and Labeling Regulation, supra note 151,
recital 3 (stating the goals of traceability requirements under the regulation).
567. See M
ACMAOLAIN, supra note 334, at 250 (discussing the motivation behind the
Traceability and Labeling Regulation); see also Traceability and Labeling Regulation, supra
note 151, recital 3 (setting forth the objectives of the regulation).
568. See Alemanno, supra note 157, at 153 (discussing the dichotomy of traceability
requirements); M
ACMAOLAIN, supra note 334, at 250 (stating that one of the reasons behind
the traceability requirements is to make the removal of harmful products from the market more
efficient).
569. See Traceability and Labeling Regulation, supra note 151, recital 4 (articulating
that the traceability requirements should be put into place in order to allow consumers to freely
choose with accurate information); Alemanno, supra note 157, at 154 (discussing the general
principle of traceability in the European Union).
570. See Traceability and Labeling Regulation, supra note 151, recital 4 (describing the
relationship between accurate information and consumer choice); see also Alemanno, supra
note 157, at 153 (stating that traceability enables consumers to be provided with targeted and
accurate information regarding a certain product).
571. See Traceability and Labeling Regulation, supra note 151, art. 4, at 1 (stating the
requirements of operators at the first stage of placing on the market). See generally
M
ACMAOLAIN, supra note 334, at 250 (explaining how the regulation is meant to ensure
traceability at all stages of the food production process).
2017] GMO LABELING IN THE US AND EU 723
writing that the product contains or consists of GMOs and must also
include a “unique identifier” assigned to those GMOs in accordance
with Article 8.
572
Under the Traceability and Labeling Regulation,
this information must continue down the chain to operators at all
subsequent stages of the production and marketing process.
573
This
traceability requirement extends longer than the supply chain, as all
operators that are a part of the marketing chain and food production
chain must have systems and standardized procedures in place to keep
that information for five years after each transaction.
574
Under Article 4, operators of products containing or consisting
of GMOs must include labels stating “this product contains
genetically modified organisms” or “this product contains genetically
modified [name of organism(s)]” on the label.
575
If the product is not
pre-packaged, the phrases “this product contains genetically modified
organisms” or “this product contains genetically modified [name of
organism(s)]” must appear on or in connection with the display of the
product.
576
As discussed in Part I of this Note, these requirements do
not apply to traces of GMOs in products in levels under a threshold
572. See Traceability and Labeling Regulation, supra note 151, art. 4, at 1 (providing
different requirements for products consisting of or containing mixtures of GMOs to be used
only and directly as food, feed, or for processing); M
ACMAOLAIN, supra note 334, at 250
(explaining the unique identifier).
573. See Traceability and Labeling Regulation, supra note 151, art. 4, at 2 (requiring
operators to ensure that the information received is transmitted in writing to the operators
receiving the products “at all subsequent stages of placing on the market of product”); see also
M
ACMAOLAIN, supra note 334, at 250 (describing Article 4(2) of the Traceability and
Labeling Regulation).
574. See Traceability and Labeling Regulation, supra note 151, art. 4, at 4 (stating that
operators must have systems and standardized procedures in place to hold the information for
five years from each transaction); M
ACMAOLAIN, supra note 334, at 250 (detailing this
requirement for all operators in the chain).
575. Traceability and Labeling Regulation, supra note 151, art. 4, at 4(B)(6) (detailing
how products consisting of or containing GMOs must be labeled); M
ACMAOLAIN, supra note
334, at 250 (explaining how operators at the initial stage of production must clearly state in
writing that the product consists of or contains a GMO).
576. See Traceability and Labeling Regulation, supra note 151, art. 4, at 4(B)(6)
(mandating how products consisting of or containing GMOs that are not pre-packaged are to
be labeled); M
ACMAOLAIN, supra note 334, at 251 (describing the requirements for products
that are not pre-packaged).
724 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
amount prescribed by the 2001 Deliberate Release Directive and
Genetically Modified Food and Feed Regulation.
577
The European Union’s current GMO labeling requirements went
through many important changes and served as a significant part of
the solution in calming public unrest about the safety of GMOs.
578
While many other changes were made to the European Union’s
regulatory system, the labeling reforms were a temporary fix that
addressed the 1997 crisis by meeting the desires of the majority of the
Member States and the public.
579
This greatly parallels the public
unrest that has existed across the United States concerning the FDA’s
refusal to require GMO labeling and the state movement to enact
GMO labeling laws in the face of the US House of Representatives
and the FDA.
580
Due to the 1992 FDA Statement of Policy on GMOs
that does not mandate GMO labeling, the states took it upon
themselves to defy the agency and create their own laws.
581
Likewise,
in 1997, EU Member States took it upon themselves to ban an
approved GMO in their territories despite the Commission’s
approval.
582
While the European Union’s structure is different from
that of the United States, the complications of the push for GMO
labeling laws are quite similar and bring about another issue with
respect to GMO labeling, which is uniformity.
583
As discussed previously in this Note, the Commission was
greatly concerned with the lack of uniformity in the European Union
as a result of the Member States’ refusal to adopt the Commission’s
577. See generally Traceability and Labeling Regulation, supra note 151, art. 4
(exempting products that contain a trace amount of GMOs); M
ACMAOLAIN, supra note 334, at
251 (discussing the trace exemption and the threshold levels found in the 2001 Deliberate
Release Directive and the Genetically Modified Food and Feed Regulation).
578. See supra notes 505-60 and accompanying text (detailing these changes).
579. See generally supra Section II.B (explaining this temporary solution).
580. See generally supra Part II (detailing the increasing public demand for GMO
labeling and the reaction of the FDA and the US House of Representatives).
581. See generally supra Section I.A (discussing the 1992 FDA Statement of Policy);
supra Section II.A (explaining the state movement towards mandatory GMO labeling).
582. See Stewart & Johanson, supra note 243, at 266-67 (giving an overview of the
Member State reaction to the authorization of Bt-maize and their reliance on Article 16 of the
1990 Deliberate Release Directive); T
HE YEAR IN TRADE, supra note 282, at 104 n.180
(explaining the actions of several Member States in reaction to the approval of Bt-maize).
583. See supra notes 362-63 and accompanying text (highlighting concerns over a
“patchwork” system that might arise as a result of different state GMO labeling laws).
2017] GMO LABELING IN THE US AND EU 725
decision to allow Bt-maize to be marketed in the European Union
without labeling.
584
Because of these concerns, GMO labeling in the
European Union would be regulated under one system, instead of
allowing the Member States to craft their own rules and legislation to
require labeling.
585
Specifically, the Traceability and Labeling
Regulation states that differences between national laws,
administrative provisions, and regulations that concern traceability
and labeling of GMOs as products or in products may hamper their
free movement and therefore create unequal and unfair
competition.
586
Furthermore, the Regulation says that in order to
contribute to the effective functioning of the internal market, there
should be a “harmonized” Community framework for labeling and
traceability of GMOs.
587
Thus, according to the Traceability and
Labeling Regulation, the labeling requirements for GMOs within the
Community framework have to be uniform in order to allow GMOs to
be unhindered in the market and to allow the EU market to function in
an effective and harmonized way.
588
It is clear from this determination
that a uniform labeling system under the Traceability and Labeling
Regulation was a key component of GMO labeling reform in the
European Union and a preferred solution to differing national laws
and regulations.
589
4. Member States Cultivation Directive
The European Union’s stance on labeling and traceability has
not changed since 2003, as the labeling of GMOs is still governed by
the Traceability and Labeling Regulation and no major changes have
been made to the requirements, including the 0.9% threshold limit.
590
584. See supra note 480 and accompanying text (explaining the Commission’s position).
585. See Traceability and Labeling Regulation, supra note 151, recital 2 (explaining the
need to have uniform rules concerning this area of GMO regulation).
586. Id. (explaining the possible complications of non-uniform traceability and labeling
requirements).
587. Id. (stating the need for uniform labeling and traceability standards).
588. Id. (discussing how the harmonized Community framework in this area contributes
to the effective functioning of the internal market).
589. Id. (highlighting the need for uniform traceability and labeling requirements for the
benefit of the internal market).
590. See Sella-Villa, supra note 294, at 983 (stating that the Traceability and Labeling
Regulation is a part of the reform and highlighting the need for uniform traceability and
726 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
The same cannot be said concerning the cultivation of GMOs in
Member State territories.
591
After thirteen Member States requested
the Commission to give them the ability to make decisions on GMO
cultivation in their territories, the request was granted under the
Member States Cultivation Directive, which gives Member States two
different options to restrict GMO cultivation in their territories.
592
Before a GMO is authorized, a Member State can demand that part or
all of its territory be exempt from the geographical scope of the
application with the agreement of the applicant.
593
There are nuances
to this option that this Note does not cover, but one important point is
that it does not require the Member State to include a justification for
its exclusion.
594
The second option allows a Member State to opt out.
595
Here, a
Member State can adopt measures to restrict or ban GMO cultivation
on part or all of its territory at any time after the GMO has been
authorized.
596
However, unlike the first option, the Member State
must justify its decision based on reasoned grounds that do not
conflict with the EU assessment of risks on health or the
environment.
597
These include land use, socio-economic impacts,
public policy, environmental/agricultural policy objectives, and town
and country planning.
598
As part of the Directive, special attention
must also be paid to the prevention of cross-border contamination
labeling requirements for the benefit of the internal market); Federici, supra note 39, at 543
(discussing the transition from the old guidelines to the current instructions under the
Traceability and Labeling Regulation).
591. See infra notes 592-99 and accompanying text (discussing the new directive that
allows Member States to restrict GMO cultivation in their territories).
592. See generally Directive (EU)2015/412 of the European Parliament and of the
Council of 11 March 2015 Amending Directive 2001/18/EC as regards The Possibility For
The Member States To Restrict Or Prohibit The Cultivation Of Genetically Modified
Organisms (GMOs) In Their Territory, 2015 O.J. L 68/1 [hereinafter Member States
Cultivation Directive].
593. See Member States Cultivation Directive, supra note 592, art. 1, at 2 (giving
Member States this option before a GMO is authorized).
594. See id. (failing to list a requirement for a justification).
595. See id. (allowing Member States to opt out).
596. See id. (stating what Member States that did not demand exemption before
authorization may do with respect to the cultivation of authorized GMOs).
597. See id. (explaining the different requirement for the Member State under this
option).
598. See id. (listing the justifications upon which the measures must be based).
2017] GMO LABELING IN THE US AND EU 727
from a Member State that permits cultivation of a GMO to a Member
State that prohibits it.
599
In accordance with EU general public
opinion, many Member States have taken advantage of the Member
States Cultivation Directive.
600
As of October 2015, two-thirds of
Member States have chosen the opt-out option under the Directive
and have requested opt-outs from the cultivation of genetically
modified crops for all or part of their territory.
601
As shown by the Member States Cultivation Directive, the
European Union continues to address issues with respect to GMOs by
changing existing procedures to better deal with specialized issues
within GMO regulation.
602
According to the Directive, experience
shows that cultivation is addressed more thoroughly at the Member
State level, while issues related to the placing on the market and the
import of GMOs should remain regulated at the Union level in order
to preserve the internal market.
603
Therefore, measures governing the
labeling and traceability of GMOs remains at the Union level
because, unlike cultivation, the uniform regulation of GMO labeling
is still considered to be paramount to the internal market and therefore
is not left to Member State discretion.
604
599. See id. recital 10 (explaining how particular attention must be paid to preventing
cross-border contamination among Member States who have made different cultivation
decisions).
600. See infra note 601 and accompanying text.
601. See Two Thirds of EU States Reject GMO Crops, File Cultivation Opt-Out
Requests, RT (Oct. 5, 2015, 3:11 AM), https://www.rt.com/news/317638-eu-gmo-cultivation-
opt-out/ (stating that two thirds of EU Member States have requested to be allowed to ban
growing GMO crops in their territories by using the “opt-out” clause of the directive);
Jonathan Stearns, Most EU Countries to Ban Cultivation of 8 GMOs Using New Rules,
B
LOOMBERG BUS. (Oct. 5, 2015, 2:42 AM), http://www.bloomberg.com/news/articles/2015-
10-05/most-eu-countries-to-ban-cultivation-of-8-gmos-using-new-rules (announcing that more
than half of the EU Member States demanded that all or part of their territory be shielded from
eight pending applications to grow GMO crops in their countries); Lorraine Chow, It’s
Official: 19 European Countries Say ‘No’ To GMOs, E
COWATCH (Oct. 5, 2015, 10:32 AM),
http://ecowatch.com/2015/10/05/european-union-ban-gmos/ (explaining how the Member
States “specifically targeted” the cultivation of Monsanto’s MON 810 Maize and how this
crop, which was under review, was the only GMO crop grown in Europe at the time).
602. See supra notes 590-604 and accompanying text (explaining the innovative policies
under the Member States Cultivation Directive).
603. See Traceability and Labeling Regulation, supra note 151, recital 2 (stating the
need for uniform labeling and traceability standards).
604. Id. (justifying the uniform approach taken for labeling and traceability).
728 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
III: ADVANCING GMO TRANSPARENCY UNDER THE
CONSUMER RIGHT TO KNOW POLICY
This Note was originally written with the intention of proposing
a federal solution to the debate that would prevent the United States
from experiencing a situation similar to the 1997 EU crisis. However,
during the course of writing this Note, President Obama signed S. 764
into law, making federal GMO labeling a reality and shutting down
the state movement that paralleled the Member State actions in 1997
during the EU crisis. As a result, the focus of this Note shifted from a
stance of warning to a position of observation and suggestions for
improvement. Thus, this Part will argue that while the United States
successfully avoided a crisis similar to that of the European Union, it
did not respond to public outcry as effectively as the European Union
did in mandating GMO labeling through the Traceability and
Labeling Regulation. This Part proposes a solution to the critical
debate occurring in the United States over mandatory GMO labeling
based on the Consumer Right to Know Policy that corrects the
deficiencies under the new federal national standard established by S.
764.
A. How the United States Avoided a Crisis Similar to the 1997 EU
Crisis
Just as the European Union reached a pinnacle in its GMO
labeling debate in 1997, the United States was at its apex, as
individual states defied the FDA and passed laws requiring GMO
labeling at the state level.
605
Similar to the 1992 FDA Statement of
Policy, the 1990 Deliberate Release Directive did not require GMO
labeling in direct conflict with public opinion.
606
When Bt-maize was
under consideration for approval in 1997 in the European Union, the
Commission approved the GMO product for the market despite
Member State objections.
607
This parallels the response of the US
federal government in 2015 with the passing of H.R. 1599 by the US
House of Representatives, which would have implemented a
605. See generally supra Part II (discussing the state movement).
606. See generally supra Part I (explaining the 1990 Deliberate Release Directive).
607. See generally supra Section I.B (describing the conditions surrounding the approval
of Bt-maize in 1997).
2017] GMO LABELING IN THE US AND EU 729
voluntary GMO labeling system that defiantly rejected the state laws
of Vermont, Connecticut, and Maine requiring GMO labeling by
manufacturers.
608
More broadly, the two responses are strikingly
similar in their defiance to public opinion concerning GMO
transparency and greater regulation of such products.
609
Just as the
Commission ignored public opinion concerning GMO transparency
for several years, the US federal government has repeatedly refused to
mandate GMO labeling based on the Consumer Right to Know
Policy.
610
It is this open defiance and refusal to consider public
opinion that brought about the 1997 EU Crisis and the recent US
national debate over GMO labeling, and which prompted severe
action in both situations.
611
The responses to these actions are also eerily similar, as both the
Member States in the European Union and individual states in the
United States took GMO regulation into their own hands and imposed
severe restrictions on GMOs in their borders.
612
While the Member
States of the European Union did not implement their own regulation
of such products as the United States did, they did refuse to adhere to
the decisions of the Commission and thereby demanded intense
change.
613
Furthermore, many of the concerns surrounding such
action were the same, as those in both the European Union and United
States feared a resulting patchwork system that would affect the
marketing of GMO products based on the borders they entered.
614
However, the most important similarity between these two
situations is the remedy used to calm public outrage and action from
the Member States in the European Union and the individual states in
608. See generally supra Section II.A.8 (providing details about the voluntary system
under H.R. 1599 and how it would affect the GMO labeling laws of these states).
609. See generally supra Part II (highlighting the strong public disapproval of such
responses).
610. See generally Parts I-II (detailing how the EU Commission and US federal
government reacted to public demand for more GMO transparency).
611. See generally Parts I-II (analyzing how intense public opinion concerning GMOs
influenced GMO regulation in both the United States and European Union).
612. See generally supra Parts I-II (demonstrating how the Member States of the
European Union and individual states of the United States took significant action in an effort
to meet public concern over GMOs).
613. See generally supra Section II.B.1 (highlighting how the Member States pushed for
significant reform in GMO regulation).
614. See generally supra Sections II.A-B (discussing such concerns).
730 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
the United States.
615
In both the European Union and United States,
mandatory GMO labeling was implemented and individual state
action ceased.
616
In the European Union, voluntary compliance with
GMO labeling standards under the 1990 Deliberate Release Directive
was replaced with mandatory rules governing the strict labeling of
GMOs based on a threshold amount of genetic material found in the
end food product under the Traceability and Labeling Regulation.
617
Almost identically in the United States, the proposed voluntary GMO
labeling system under H.R. 1599 was superseded by the mandatory
national standard under S. 764, which requires GMO labeling based
on an amount of bioengineered substance found in a food.
618
Thus, the United States avoided a debacle like the 1997 EU
Crisis by implementing a system that greatly mirrors that of the
European Union under the Traceability and Labeling Regulation and
requires GMO labeling based on an amount found in the end product,
as opposed to mandating labeling based on genetic engineering
alone.
619
The urgency with which S. 764 was implemented also
greatly parallels the actions of the European Union during the 1997
Crisis, in which the Commission implemented a temporary fix and
used a fast track procedure to implement the necessary changes.
620
S.
764 was crafted and passed within less than a year of H.R. 1599’s
exclusion from the Federal Spending Bill and within a month of July
1, 2016, which was the date that Vermont’s Act 120 went into
effect.
621
Therefore, it is clear that the United States avoided a crisis
615. See generally supra Parts I-II (providing an extensive discussion about how the
European Union and United States developed solutions to the significant public unrest about
the lack of GMO transparency).
616. See generally supra Parts I-II (demonstrating how the implementation of GMO
labeling requirements stopped individual action).
617. See generally supra Sections II.B.2-3 (detailing how mandatory GMO labeling
requirements were introduced to the European Union through the Traceability and Labeling
Regulation).
618. See generally supra Sections II.A.8-9 (showing how the proposed voluntary system
under H.R. 1599 was replaced with the mandatory system under S. 764).
619. See generally supra Section II.A.9 (explaining the requirements under S. 764).
620. See generally supra Sections II.B.2-3 (explaining the actions of the Commission
during this time).
621. See generally supra Section II.A.9 (discussing the circumstances surrounding the
passage of S. 764).
2017] GMO LABELING IN THE US AND EU 731
much like that of the European Union by using a very similar solution
with the same sense of haste and necessity.
622
1. The United States Avoided a Crisis, But Missed the Goal
As just demonstrated, the United States has taken crucial steps
that eliminated a patchwork system of state GMO labeling laws and
that will likely prevent a crisis similar to what the European Union
experienced in 1997 with regard to GMO labeling.
623
However, the
avoidance of such a crisis is not the sole indicator of success here, as
the new GMO labeling requirements under S. 764 do not adequately
address the concerns of many consumers who desire GMO
transparency and have significant deficiencies that result in
inaccessibility to GMO information for certain parts of the
population.
624
It is because of these issues that S. 764 is not as
successful of a solution to the GMO conflict in the United States as
the Traceability and Labeling Regulation was in the European
Union.
625
The rest of this Note highlights these shortcomings and
argues that S. 764 should be repealed and replaced with a mandatory
federal GMO labeling system that is based on the process used in the
production of the food, instead of how much bioengineered matter is
present in a final food product.
626
Through this mandatory system, the
United States can simultaneously avoid a crisis like that of the
European Union and also meet the call of the US population for GMO
transparency under the Consumer Right to Know Policy.
627
622. See generally supra Section II.B.2 (demonstrating the fast track approach used to
enact GMO reform in the wake of the 1997 crisis).
623. See supra notes 605-22 and accompanying text (providing an overview of these
steps).
624. See generally supra Section II.A.10 (describing some of the criticisms of S. 764).
625. See generally supra Section II.B.3 (explaining how public concerns in the European
Union were adequately addressed by the Traceability and Labeling Regulation).
626. See infra notes 628-726 (highlighting the deficiencies of S. 7764 and suggesting
improvements to correct them).
627. See generally supra Section II.A.1 (detailing the Consumer Right to Know Policy);
supra Section II.B (discussing the 1997 EU Crisis).
732 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
B. The Deficiencies of S. 764
1. S. 764 Does Not Provide the GMO Transparency Desired Under
the Consumer Right to Know Policy
One of the most significant issues with S. 764 is the way in
which GMO information is presented to consumers on the food
packaging.
628
Even though S. 764 is only applicable to foods that have
been deemed “bioengineered” under the standards set forth by the
Secretary of Agriculture, the words “bioengineered,” “genetically
engineered,” or “genetically modified” will not appear on the
packaging.
629
In fact, such language is not permitted to accompany
the three methods of disclosure, as manufacturers must only put
language indicating that such disclosures will provide “food
information.”
630
There is an argument to be made that if disclosures
were required to be accompanied by terms such as “bioengineered” or
“genetically modified,” certain manufacturers would be at a
disadvantage and consumers might be unnecessarily deterred from
purchasing foods with such labels.
631
However, the demands of the
Consumer Right to Know Policy clearly outweigh such possibilities,
as a failure to require such terms severely threatens the goals of GMO
transparency and might result in consumers remaining largely
uninformed about the GE nature of their foods.
632
Forbidding language such as “genetically engineered” or
“genetically modified” to accompany disclosures on packages may
also result in serious consumer confusion and misinformation.
633
While consumers may become aware that the statement “call for more
food information” indicates that a food has been genetically modified,
this is only a possibility that could take years to become a reality.
634
628. See generally supra Section II.A.9 (discussing how such information is displayed).
629. See generally supra Section II.A.9 (explaining the packaging requirements under S.
764).
630. See generally supra Section II.A.9 (setting forth this prohibition).
631. See generally supra Section II.A.7 (generally explaining some of these arguments
with respect to GMO labeling laws that require such language on packaging).
632. See generally supra Section II.A.1 (presenting the goals of the Consumer Right to
Know Policy).
633. See generally supra Section II.A.10 (highlighting this argument).
634. See generally supra Section II.A.9 (explaining that the only language to appear on
food packaging is “call for more food information”).
2017] GMO LABELING IN THE US AND EU 733
Until that time, consumers will be responsible for discovering that
such a statement correlates to information about bioengineering and
that any food containing this statement is subject to federal GMO
labeling requirements.
635
Additionally, consumers might mistakenly
believe that the words “food information” concern nutritional
information, allergen content, or some other aspect of food
information that does not involve genetic engineering.
636
This
possible consumer misinformation and confusion greatly defeats the
stated purpose of S. 764 and GMO labeling requirements in general,
while also falling short of the goals of the Consumer Right to Know
Policy.
637
2. S. 764’s Burden on Consumers
In addition to consumer confusion and misinformation, the
absence of GE information directly on the package places a burden on
consumers that will likely decrease GMO transparency.
638
By placing
the burden on the consumer to find out GMO information by either
calling a telephone number or using their mobile device to access a
website, consumers will lose their own valuable time and must
overcome an extra hurdle to access the GMO information they wish
to procure.
639
If consumers are required to spend their time and
resources to find out this information for each food product they wish
to purchase, consumers might either not attempt to find out such
information or not purchase the food at all.
640
Either of these results
produce negative consequences, as consumers will still remain
uninformed about the GMO status of their food and manufacturers
might be disadvantaged if consumers unnecessarily avoid certain
635. See generally supra Section II.A.10 (discussing the burden on consumers under S.
764 to find out this information).
636. See generally supra Section II.A.10 (discussing the obscurity of the phrase “call for
more food information”).
637. See generally supra Section II.A.1 (explaining the goals of the Consumer Right to
Know Policy with respect to GMO transparency).
638. See generally supra Section II.A.10 (highlighting this critical view of S. 764).
639. See generally supra Section II.A.10 (detailing this burden on consumers).
640. See generally supra Section II.A.10 (analyzing how the disclosure requirements of
S. 764 results in the use of consumer time and effort).
734 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
foods that they might otherwise purchase if they knew more specific
GMO information.
641
These burdens also might result in inaccessibility to GMO
information for many consumers and therefore make GMO
transparency only available to those who have easy access to
telephones or the internet.
642
As discussed in Part II, individuals who
are elderly or financially disadvantaged might not have the devices
necessary to make such phone calls or log onto the companies’
websites.
643
By allowing disclosure only through these measures, S.
764 essentially eliminates these consumers from any possible
increased GMO transparency and disadvantages significant portions
of the US population based on factors that cannot easily be
changed.
644
As just demonstrated, S. 764 puts a severe burden on consumers
that can result in consumer confusion, misinformation, and exclusion
from GMO transparency.
645
This clearly conflicts with the idea of
GMO transparency in general, which is based on increasing consumer
access to GMO information and removing any obstacles to such
access.
646
By hindering consumer access and thereby discouraging
GMO transparency, S. 764 fails to achieve the goals of GMO labeling
and the Consumer Right to Know Policy.
647
3. Problems with Basing GMO Labeling Requirements on the Final
Product and a Threshold
Perhaps the most severe deficiency of S. 764 is the way in which
foods become subject to the law’s federal GMO labeling
641. See generally supra Section II.A.10 (highlighting some of the negative
consequences of S. 764 and the burden that it places on consumers).
642. See generally supra Section II.A.10 (describing the critical challenges facing these
individuals as a result of the disclosure requirements under S. 764).
643. See generally supra Section II.A.10 (explaining the special challenges facing these
groups).
644. See generally supra Section II.A.9 (setting forth the disclosure methods of S. 764,
which do not include using direct language on the packaging that indicates the GE status of a
food).
645. See generally supra Section II.A.10 (describing this burden).
646. See generally supra Section II.A.1 (showing the purposes of the Consumer Right to
Know Policy with respect to GMO labeling).
647. See generally supra Section.A.1 (highlighting these goals).
2017] GMO LABELING IN THE US AND EU 735
requirements.
648
Instead of requiring foods to be labeled based on the
genetic engineering process alone, S. 764 will only require a food to
be labeled if it meets the threshold amount of bioengineered substance
required to deem it a bioengineered food under the law.
649
While the
statute does not use the word “threshold,” the language of the statute
implies this term.
650
According to S. 764, the Secretary of Agriculture
must determine the amounts of a bioengineered substance that may be
present in a food product in order for it to be a bioengineered food.
651
Thus, any food that contains that specified amount will be deemed a
bioengineered food and subject to the labeling requirements.
652
This
implements a threshold requirement, as a food will only be labeled
under the law if it contains the determined amount of bioengineered
substance in the final product.
653
Therefore, any reference in this Note
to a threshold level under S. 764 will refer to this statutory
language.
654
As previously discussed, this assignment of responsibility places
the regulation of GMOs, which were historically regulated solely by
the FDA with regards to food, under another part of the regulatory
system.
655
The FDA expressed concerns about this assignment before
S. 764 became law, warning that the new GMO standards may
conflict with existing FDA regulations and places GMO regulation
outside the sole jurisdiction of the FDA.
656
According to the FDA,
these conflicts could have serious implications for consumers and
convolute the effort to provide more transparency on food labeling
because different labeling requirements can create confusion or
648. See generally supra Section II.A.9 (demonstrating how foods become subject to the
requirements).
649. See generally supra Section II.A.9 (explaining how a food product will only have to
be labeled if it meets the threshold level for bioengineered foods under S. 764).
650. See generally supra Section II.A.9 (providing the language of the statute).
651. See generally supra Section II.A.9 (describing this requirement).
652. See generally supra Section II.A.9 (detailing how foods become subject to the
requirements).
653. See generally supra Section II.A.9 (discussing the threshold level).
654. See generally supra Section II.A.9 (discussing the threshold level).
655. See generally supra Section I.A.2 (detailing the responsibilities of the FDA with
respect to GMOs under the Coordinated Framework).
656. See generally supra Section II.A.9-10 (setting forth these concerns).
736 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
inconsistencies in packaging, thereby restricting GMO
transparency.
657
In addition to possible conflicts with FDA requirements, labeling
GMOs based on the contents of the final product presents other
serious problems that further restrict GMO transparency and stand
contrary to the goals of the Consumer Right to Know Policy.
658
As
indicated by the FDA, the definition of bioengineered foods in S. 764
is narrow and may eliminate several foods that come from GE
sources, including oil made from GE soy, starches, and purified
proteins.
659
Furthermore, S. 764 applies labeling rules to foods only
where the genetic modification cannot otherwise occur through
conventional breeding or be found in nature.
660
According to the
FDA, proving that such modification “could not” be obtained through
conventional breeding or occur in nature might be difficult.
661
This
could potentially further narrow GMO labeling requirements and
allow manufacturers to argue that their foods need not be labeled
since it cannot be proven that their genetic modification cannot be
obtained through conventional breeding.
662
By excluding many foods
from GMO labeling requirements through this potential loophole, S.
764 results in inadequate GMO transparency and fails to achieve the
goals of other measures, such as Act 120, that do not require such
proof.
663
Mandating GMO labeling based on a threshold also fails to
provide information to many consumers who desire GMO
transparency for various reasons under the Consumer Right to Know
657. See generally supra Section II.A.1 (explaining the transparency goals of GMO
transparency labeling with pursuant respect to the Consumer Right to Know Policy).
658. See generally supra Section II.A.10 (setting forth some of these serious problems).
659. See generally supra Section II.A.10 (presenting the arguments of the FDA
regarding the scope of the definition and the possible exclusion of such foods from GE sources
from the labeling requirements).
660. See generally supra Section II.A.9 (explaining this specific requirement under S.
764).
661. See generally supra Section II.A.10 (discussing this difficulty).
662. See generally supra Section II.A.10 (giving an overview of the argument that S.
764 will allow manufacturers to hide GMO information from consumers through potential
loopholes and conditions).
663. See generally supra Section II.A.10 (describing how S. 764 contains possible
loopholes that would restrict GMO transparency).
2017] GMO LABELING IN THE US AND EU 737
Policy.
664
As previously discussed, there are a myriad of reasons why
individuals want to know if their food has been genetically engineered
or modified, including religious and ethical beliefs.
665
For example, a
person might want to avoid food that has been genetically engineered
due to a personal objection to the genetic modification of food.
666
Under S. 764, such an individual would still not be able to avoid all
genetically modified food, since genetic engineering alone does not
subject a food to federal labeling requirements.
667
If a food has been
genetically engineered but does not meet the threshold level of a
bioengineered substance in the final product to be classified as a
bioengineered food, that food will not be required to meet the GMO
disclosure requirements under S. 764.
668
Thus, the individual who
wishes to avoid any genetically modified food will not be aware that a
food has been genetically modified and will unknowingly violate his
or her beliefs by consuming it.
669
As also previously discussed in Part II, there are many
individuals who want to avoid certain GMOs due to religious beliefs,
including those who keep Kosher diets.
670
An individual who is
keeping a Kosher diet and wants to avoid a certain substance entirely
would encounter the same dilemma as an individual who is ethically
opposed to genetic modification of food.
671
The person keeping a
Kosher diet would not be aware that a final food product contains a
certain amount of that substance if it does not meet the threshold
664. See generally supra Section II.A.9 (explaining how GMOs will come under
labeling requirements based on a threshold level for bioengineered food).
665. See generally supra Section II.A.1 (highlighting some of these reasons under the
Consumer Right to Know Policy).
666. See generally supra Section II.A.1 (listing this type of objection as one of the many
justifications for GMO labeling under the Consumer Right to Know Policy).
667. See generally supra Section II.A.9 (explaining how foods become subject to the
GMO labeling disclosure requirements under S. 764, which is based on whether a food meets
the definition of “bioengineered food” under the law and not whether the food was genetically
engineered).
668. See generally supra Section II.A.9 (stating that a food will only be required to
contain a GMO disclosure if it meets the threshold level of bioengineered substances).
669. See generally supra Section II.A.1 (discussing the concerns of this type of
individual under the Consumer Right to Know Policy).
670. See generally supra Section II.A.1 (highlighting the concerns of such individuals).
671. See supra notes 367-68 and accompanying text (explaining the problem faced by
such an individual).
738 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
level.
672
This would cause such an individual to consume a substance
that violates his or her beliefs and therefore increase consumer
misinformation.
673
This is yet another way in which S. 764 fails to
result in optimal GMO transparency and does not meet the high
standards of the Consumer Right to Know Policy, which should serve
as the basis for GMO labeling in the United States.
674
4. S. 764 Fails to Achieve the Goals of the Consumer Right to Know
Policy
While S. 764 has brought GMO labeling under a federal regime
that avoids the patchwork system consisting of the state GMO
labeling laws of Vermont, Connecticut, and Maine, it clearly fails to
achieve the goals of the Consumer Right to Know Policy and contains
many severe deficiencies that limit GMO transparency.
675
Instead of
increasing consumer access to GMO information, S. 764 increases
consumer confusion and misinformation by regulating GMO labeling
based on a threshold system and barring descriptive GMO
information on food labels.
676
Such a system presents an even more
dangerous reality than the lack of labeling under the 1992 FDA
Statement of Policy: misperception of GMO transparency.
677
This
misperception could occur because consumers may believe they have
more GMO information than they actually do.
678
As shown, S. 764
creates potential loopholes and exceptions that exclude certain foods
that the public might otherwise consider genetically engineered from
federal labeling requirements.
679
Thus, consumers may mistakenly
believe that any food that does not bear a disclosure has not been
672. See generally supra Section II.A.9 (demonstrating that even though a food has been
genetically engineered, it will not be required to contain a disclosure if it does not meet the
threshold level under S. 764).
673. See generally supra Section II.A.1 (explaining the concerns of individuals who
keep a Kosher diet).
674. See generally supra Section II.A.1 (setting forth the goals of the Consumer Right to
Know Policy regarding GMO transparency).
675. See generally supra Sections II.A.3-4, 6 (giving an overview of these state GMO
labeling laws and their different requirements).
676. See generally supra Section II.A.9 (analyzing these aspects of S. 764).
677. See generally supra Section I.A.3 (detailing the 1992 FDA Statement of Policy).
678. See generally supra Section II.A.10 (discussing how S. 764 results in less GMO
transparency than it projects to).
679. See generally supra Section II.A.10 (highlighting some of these loopholes).
2017] GMO LABELING IN THE US AND EU 739
genetically modified and unknowingly continue to purchase and
consume it under this misperception.
680
Since GMO labeling
measures should seek to avoid that very result, S. 764 is an inadequate
solution to the GMO labeling debate in the United States and should
be replaced with a federal law requiring GMO labeling based on the
process used in food production instead of a threshold level of a
bioengineered substance found in a final food product.
681
By
implementing such a measure, the United States could achieve the
same level of success that the European Union achieved with the
Traceability and Labeling Regulation and meet the needs of US
citizens who desire true GMO transparency under the Consumer
Right to Know Policy.
682
C. Furthering Progress in GMO Transparency
1. The Solution to the GMO Labeling Debate in the United States
As shown by the Traceability and Labeling Regulation, one of
the main goals of EU GMO labeling regulation is to enable
consumers to make an informed decision about the products they
buy.
683
Thus, while the European Union does not have a statutory
“Consumer Right to Know,” it does acknowledge and uphold
citizens’ rights to make informed decisions by requiring food
manufacturers to provide accurate and non-misleading information
about the GMO status of their food.
684
This concern for consumer
choice exists and thrives in a system that is based on independent risk
assessment and traceability standards that stop risk at the source or
along the supply chain.
685
This demonstrates that measures taken to
protect consumers’ ability to make informed choices do not oppose a
680. See generally supra Section II.A.9 (detailing the requirements of S. 764).
681. See generally supra Section II.A.1 (explaining GMO transparency through the lens
of the Consumer Right to Know Policy).
682. See generally supra Parts I-II (explaining the desire of the American public for
GMO transparency and how the European Union has achieved such transparency).
683. See generally supra Section II.B (highlighting this goal of the regulation).
684. See generally supra Section II.B.3 (describing how this right is recognized in the
European Union).
685. See generally supra Section II.B.3 (detailing the traceability requirements and their
justifications under the Traceability and Labeling Regulation).
740 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
system that is based on science and accurate current knowledge, and
in fact can be a part of that same system.
686
As opposed to the FDA’s policy on GMOs, which is based on
the belief that GMOs are GRAS and safe until proven otherwise, the
European Union’s regulatory system is based on the precautionary
principle and presumes that GMOs are not safe until proven
otherwise.
687
However, these two systems can have common ground
in the Consumer Right to Know Policy because the European Union’s
Traceability and Labeling Regulation governs GMOs that have been
approved through the regulatory system under the Genetically
Modified Food and Feed Regulation.
688
Thus, any GMOs that are
labeled under the Traceability and Labeling Regulation have already
been deemed safe and not a significant risk under the Genetically
Modified Food and Feed Regulation and the precautionary
principle.
689
Through mandatory labeling, the European Union wants
to ensure traceability in order to avoid future risk under the
precautionary principle and to also allow consumers to make
informed choices.
690
Once an approved GMO enters the EU
marketplace, it is considered safe, and thus the European Union and
the US FDA have a similar view of that product going forward.
691
However, the European Union still requires GMO labeling in order to
ensure traceability and to allow consumers to make informed
686. See generally supra Section I.B.1-3 (explaining how the EU GMO regulatory
system encompasses both the precautionary principle and informed consumer choice).
687. See generally supra Section I.B.1-3 (explaining the precautionary principle and its
function in EU GMO regulation).
688. See generally supra Sections I.B, II.B.8-9 (discussing the GMO scope authorization
procedure and the tracing and labeling requirements that attach after such authorization is
given of this regulation).
689. See generally supra Sections I.B, II.B.8-9 (discussing how only GMOs that have
been approved under the Genetically Modified Food and Feed Regulation are put on the
market and labeled under the Traceability and Labeling Regulation).
690. See generally supra Sections I.B, II.B.9-10 (detailing the goals of the EU regulatory
system with respect to mandatory labeling).
691. See generally supra Sections I.B, II.B.10 (explaining the views of the United States
and European Union of GMOs at each stage of approval).
2017] GMO LABELING IN THE US AND EU 741
decisions.
692
This is why the Consumer Right to Know Policy can be
a valid basis for mandatory GMO labeling in the United States.
693
While these two different regulatory systems do have common
ground, there is an important distinction between the Traceability and
Labeling Regulation and a US law based on the Consumer Right to
Know Policy that should make a difference with respect to how GMO
products are labeled in the United States.
694
While there is no
indication of how the threshold level of 0.9% was determined in the
Traceability and Labeling Regulation, it is clear from the EU system
that GMO labeling is not required simply because a product was
developed through genetic engineering.
695
Instead, there must be a
certain amount of a GMO present in a product before it must be
labeled.
696
This is to avoid requiring labels for products that have an
unavoidable or undetectable amount of GMO matter.
697
Since the
United States does not operate from a position resembling the
precautionary principle, mandating GMO labeling based on a
threshold under S. 764 does not result in the same high amount of
GMO transparency as achieved by the Traceability and Labeling
Regulation.
698
While S. 764 and the Traceability and Labeling Regulation share
many attributes, it is this difference in position that makes the latter a
success and renders the former inadequate.
699
Because the
Traceability and Labeling Regulation uses a threshold level in the
context of the precautionary principle and an entire GMO regulatory
692. See generally supra Sections I.B, II.B (discussing how GMOs that have been
approved and deemed safe under the precautionary principle still must be labeled in the
European Union).
693. See generally supra Section II.A.1 (explaining the basis for GMO labeling in the
Consumer Right to Know Policy).
694. See generally supra Part I (describing and comparing the GMO regulatory systems
of the United States and the European Union).
695. See generally supra Section II.B.3 (explaining this requirement under the
Traceability and Labeling Regulation).
696. See generally supra Section II.B.3 (detailing this requirement within the threshold).
697. See generally supra Section II.B (discussing the justification for the threshold
level).
698. See generally supra Part I (highlighting how the United States operates from the
substantial equivalence doctrine, which greatly differs from the precautionary principle that
serves as the basis of the EU GMO regulatory system).
699. See generally supra Part I (demonstrating this difference in position).
742 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
system based on independent investigation, the threshold level meets
the public demand for GMO transparency and is an adequate remedy
for public distrust of GMOs.
700
The use of a threshold amount in S.
764 in the United States fails to achieve the same level of success
because it contrasts with the 1992 FDA Statement of Policy on GMOs
and does not meet public demand, as it is not clear how this threshold
level will be determined.
701
If the threshold level is established based
on the effects on human health, then the GMO labeling requirements
will stand in stark opposition to the FDA’s presumption that GMOs
are safe.
702
Furthermore, a threshold level based on effects on human health
will result in consumer misinformation.
703
Such a threshold level
would significantly ignore the concerns of many individuals who
wish to avoid certain GMOs or GMOs entirely because of their
religious or ethical beliefs.
704
For example, an individual who
ethically opposes genetic engineering will not be aware if all foods
have been genetically engineered since a food will have to contain the
threshold level of bioengineered substance that has an effect on
human health in order to be subject to labeling requirements under S.
764.
705
As certain individuals want GMO transparency for reasons
independent of the effects of GMOs on human health, this type of
threshold could result in a narrow application that will deprive
individuals from obtaining the information they need to live
according to their beliefs.
706
Determining the threshold using factors other than effects on
human health might still lead to the same problem, since it is not clear
700. See generally supra Section I.B.9 (explaining the threshold system in the shadow of
the precautionary principle).
701. See generally supra Section I.A.3 (analyzing the 1992 FDA Statement of Policy
and its emphasis on the substantial equivalence doctrine).
702. See generally supra Section I.A.3 (discussing the FDA’s position that GMOs are
substantially equivalent to their traditional counterparts).
703. See infra notes 704-06 (giving examples of these concerns).
704. See generally supra Section II.A.1 (explaining some of the concerns of such
individuals and how they are protected by the Consumer Right to Know Policy).
705. See generally supra Section II.A.9 (describing how foods only must be labeled
under S. 764 if they meet the threshold level of bioengineered substances).
706. See generally supra Section II.A.1 (detailing how many individuals desire GMO
transparency for reasons that do not involve the effects of GMOs on human health).
2017] GMO LABELING IN THE US AND EU 743
what factors will be used and how they will be weighed.
707
Misinformation might still occur, as it is not guaranteed that such
factors will adequately meet the concerns of US citizens who desire
GMO labeling under the Consumer Right to Know Policy.
708
Factors
that meet the concerns of those who desire GMO transparency for
religious reasons might not be the same as those that meet the
concerns of people who want it for ethical reasons.
709
Thus, choosing
factors used to set a threshold might result in a disadvantage to certain
groups who demand GMO transparency under the Consumer Right to
Know Policy, as certain factors that meet the concerns of specific
groups might be favored over others.
710
It is because of these possible and significant complications that
a threshold should not be used in mandating GMO labeling in the
United States.
711
As shown by these possible consequences, a GMO
labeling system based on such a threshold results in inadequate GMO
transparency and frustrates the goals of the Consumer Right to Know
Policy.
712
Such negative outcomes can be avoided by replacing S. 764
with a mandatory GMO labeling system based on the process used in
food production, which will meet the concerns of various groups
under the Consumer Right to Know Policy and result in far greater
GMO transparency.
713
2. Tailoring the Solution to US GMO Policy
While mandating GMO labeling under a universal standard like
the Traceability and Labeling Regulation is the solution to the GMO
labeling debate in the United States, it is not the complete answer to
707. See generally supra Section II.A.9 (demonstrating how S. 764 directs the Secretary
of Agriculture to set a threshold level for bioengineered foods).
708. See generally supra Section II.A.1 (analyzing many of the concerns of US citizens
who demand GMO labeling under the Consumer Right to Know Policy).
709. See generally supra Section II.A.1 (setting forth some of the differing concerns that
are at stake).
710. See generally supra Section II.A.1 (discussing some of these groups and their
specific issues with respect to GMO consumption).
711. See supra notes 703-10 and accompanying text (explaining these complications).
712. See generally supra Section II.A.1 (setting forth some of these goals).
713. See supra notes 363-72 and accompanying text (discussing the concerns of different
groups in society under the Consumer Right to Know Policy).
744 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
the problem.
714
As shown, mandating GMO labeling under a
threshold system similar to that under the Traceability and Labeling
Regulation limits the progress made by GMO labeling proponents and
does not parallel the high success achieved under the Traceability and
Labeling Regulation in the European Union.
715
After learning from
the European Union’s example and avoiding a GMO crisis by passing
federal labeling requirements, the United States should now diverge
from the model of the Traceability and Labeling Regulation and
require GMO labeling for products based on the genetic engineering
process used in food production, instead of basing the requirement on
a threshold level of bioengineered substance in the final product.
716
This would prevent the FDA from having to change its 1992
Statement of Policy and would address the concerns of the US
citizens under the Consumer Right to Know Policy.
717
The federal law should also model the approach taken by
Vermont, Connecticut, and Maine by requiring GMO information to
be displayed directly on the food package or on a nearby display,
depending on the type of food.
718
Specifically, any food subject to the
regulation would be required to have the statement “produced with
genetic engineering” printed on the label.
719
It is not clear whether the
federal law should ban the use of “natural” or similar words that
might mislead consumers, or if the law should define “natural,” as
this concerns many issues within the expertise of the FDA.
720
Mandating GMO labeling through this type of federal law that is
based on the process instead of a threshold amount would correct
714. See generally supra Section II.B.9 (explaining the mandatory system under the
Traceability and Labeling Regulation).
715. See supra notes 699-712 and accompanying text (explaining how a threshold
system leads to these negative results).
716. See generally supra Section II.B (detailing the EU crisis and the European Union’s
response); supra Section III.A (describing how the United States successfully avoided such a
crisis).
717. See generally supra Section I.A.7 (explaining the 1992 FDA Statement of Policy);
supra Section II.A.8 (analyzing the Consumer Right to Know Policy).
718. See generally supra Sections II.A.3-4, 6 (detailing the packaging requirements
under these state laws).
719. See generally supra Sections II.A.3-4, 6 (providing this language from the state
laws of Connecticut, Maine, and Vermont).
720. See generally supra Section I.A.2 (giving an overview of the FDA’s specific
duties).
2017] GMO LABELING IN THE US AND EU 745
many of the significant deficiencies of S. 764.
721
Requiring “produced
with genetic engineering” or similar language directly on a food label
will eliminate much of the consumer confusion and misinformation
that will result under the current disclosure requirements under S.
764, such as a telephone number or website information accompanied
by the generic statement about “food information.”
722
Consumers will
be immediately notified that the food in their hands has been
genetically engineered, thereby resulting in instantaneous GMO
transparency.
723
Consumers will also be relieved of the burdens of S.
764, as they will not have to call a phone number or access a website
to find out GMO information.
724
This also eradicates the disadvantage
to financially disadvantaged and elderly consumers who may not be
able to access GMO information under S. 764 because of limited
access to phones or the internet.
725
By eliminating such burdens under
S. 764, this federal law again will result in immediate GMO
transparency and meet the demands of the Consumer Right to Know
Policy.
726
CONCLUSION
The parallels between the EU crisis in 1997 and the current
debate in the United States are staggering.
727
As the public demand
for GMO labeling was being met at the state level and essentially
opposed at the federal level, a tricky battle between Congress and the
individual states manifested.
728
In order to preserve order, maintain
continuity, and to avoid many of the potential negative effects
721. See supra Sections II.A.9-10 (detailing these deficiencies).
722. See supra Section II.A.9 (explaining the current disclosure requirements under S.
764).
723. See supra notes 638-44 and accompanying text (demonstrating how a lack of
language indicating GMO status directly on packages leads to consumer confusion and
misinformation).
724. See supra Section II.A.9 (detailing these methods of accessing GMO information
under S. 764).
725. See supra Section II.A.10 (discussing the specific challenges facing individuals in
these groups in accessing GMO information under S. 764).
726. See generally supra Section II.A.1 (explaining the goals of the Consumer Right to
Know Policy).
727. See generally supra Section II.A (detailing the GMO labeling dispute in the United
States); supra Section II.B.1 (describing the 1997 EU crisis).
728. See generally supra Section II.A (analyzing this conflict).
746 FORDHAM INTERNATIONAL LAW JOURNAL [Vol. 40:2
discussed above, the US Congress followed the example of the
European Union and enacted a federal GMO labeling law that bases
GMO labeling on a threshold system with a focus on the end
product.
729
While the United States successfully avoided a crisis that
the European Union faced in 1997, it failed to parallel the successful
example of the European Union when it enacted the Traceability and
Labeling Regulation in response to public outcry.
730
By using a
threshold system and thereby failing to mandate GMO labeling based
on the genetic engineering process used in food production, the
United States has provided a solution that restricts GMO transparency
and does not address the concerns of its citizens under the Consumer
Right to Know Policy.
731
The US Congress should correct these
problems by replacing S. 764 with a federal law mandating GMO
labeling based on genetic processes used in food production, as
opposed to a threshold system.
732
In addition to complying with the
1992 FDA Statement of Policy, this solution will result in optimal
GMO transparency and make GMO information accessible to all.
733
729. See generally supra Section III.A.1 (demonstrating how the United States avoided
this crisis).
730. See generally supra Section II.B (discussing the success of the Traceability and
Labeling Regulation).
731. See generally supra Section II.A.10 (explaining these critiques of S. 764).
732. See generally supra Section III.C (explaining this solution).
733. See generally supra Section III.C.1 (highlighting the benefits of mandating GMO
labeling based on genetic processes used in food production); supra Section III.C.2 (discussing
how the solution can be implemented in accordance with US GMO policy).
