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Reasons for Labeling of Genetically Engineered Foods
March 19, 2012
TO:
AMA Council on Science and Public Health
FROM:
Michael Hansen, Ph.D., Senior Scientist, Consumer Reports
RE:
Resolutions 508 (Illinois) and 509 (Indiana) Supportin
g Federal Legislation and/or Regulations that
Require Clearly Labeling Food with Genetically Engineered Ingredients
SUMMARY:
Based on the scientific uncerta
inty surrounding both the molecular
characterization of genetically
engineered (GE) crops as well as the detection of potential
allergenicity, there is more than enough uncerta
inty to decide to re
quire labeling of foods
produced via GE as a risk management measure
as a way to identify uni
ntended health effects
that may occur post approval. If foods are not labe
led as to GE status, it
would be very difficult
to even identify an unexpected heal
th effect resulting from a GE food.
Dear Council Members:
I am writing to submit scientific evidence
which strongly suppor
ts the intent of
Resolutions 508 and 509 Supporting Federal Legisl
ation and/or Regulations that Require
Clearly Labeling Food with Geneti
cally Engineered Ingredients.
Consumer Union
1
supports
mandatory labeling for foods produced with gene
tically engineered (GE) ingredients for a
number of reasons.
1.
There has been global agreement that genetically engineered foods are different
than conventionally bred foods and that
all genetically engineered foods should be
required to go through a safety assessment prior to approval.
Codex Alimentarius is
the food safety standards organization of the United Nations, and is jointly run by the
Food and Agriculture Organization (FAO) a
nd the World Health Organization (WHO).
From 2000 – 2008, there were two rounds
of the Codex Alimentarius
Ad Hoc
Intergovernmental Task Force on Foods Deri
ved from Biotechnology. This Task Force
developed a number of documents, including
a Guideline for the C
onduct of Food Safety
Assessment of Foods Derived from
Recombinant-DNA Plants (CAC/GL 45, 2003)
2
;
there are separate Guidelines for GE animals and GE microorganisms, as well. The
World Trade Organization (WTO)
considers that, in terms of
food safety, the standards or
guidelines of Codex Alimentarius are deem
ed the global science-based standard and,
thus, immune to trade challeng
es, i.e. they are not considered to be a “non-tariff trade
barrier.”
1
Consumers Union is the public policy
and advocacy division of Consumer
Reports. Consumers Union works for
telecommunications reform, health reform
, food and product safety, financial reform
, and other consumer issues. Consumer
Reports is the world’s largest independent
product-testing organization. Using its mo
re than 50 labs, auto test center, and
survey research center, the nonprofit rates thousands of produc
ts and services annually. Founded in 1936, Consumer Reports
has over 8 million subs
cribers to its magazine, website, and other publicat
ions, and a few noncommercial grants. Roughly 8
million people subscribe to
Consumer Reports or
Consumer Reports online.
2
At:
http://www.codexalimentarius.ne
t/web/standard_list.do?lang=en
2
The reason for two rounds of the Codex Alimentarius
Ad Hoc
Intergovernmental Task
Force on Foods Derived from Biotechnology came as
a result of a global agreement that genetic
engineering is a process that
is sufficiently different from conventional breeding that foods
developed via genetic engineering should go thro
ugh a safety assessment before such foods are
allowed on the market. For information on th
e ways genetic engineering differs from
conventional breeding, see Hansen, 2000.
3
Last year, after more than 15 years of
debate, the Codex Committee on Food Labeling
agreed to forward a document on labeling of GE
foods to the Codex Alimentarius Commission
for approval. Last July, at the conclusion
of the meeting of the Codex Alimentarius
Commission, the World Health Organization News put
out a letter to jour
nalists, noting that the
”Codex Alimentarius Commission has stated that
governments are free to decide on whether and
how to label foods derived from modern bi
otechnology, including foods
containing genetically-
modified organisms. The labeling should be done
in conformity with the text approved by the
Codex Commission, to avoid a potential trade barr
ier. The decision, which will help inform
consumers’ choices regardi
ng genetically-modified foodstu
ffs, was taken at the 34
th
Session of
the Commission, held in Geneva from 4-9 July
2011. More than 600 delegates from 145 of the
184 member countries, UN, inter-governmental
and non-governmental orga
nizations attended.”
4
Unlike all other developed countries, the US Food and Drug Administration (FDA) does
not require safety testing for GE plants.
The FDA’s original policy on GE (or GM, for
genetically modified) plants wa
s introduced at a press conferen
ce at an industry gathering on
May 28, 1992 by then Vice-President Dan Quayle as
a de-regulatory initiative. The policy was
based on the notion “that the new techniques [e.g.
genetic engineering] are extensions at the
molecular level of traditional me
thods and will be used to achieve the same goals as pursued
with traditiona
l plant breeding,”
5
and therefore should
be regulated in the same way. In other
words, no requirement for human safety test
ing; instead there ar
e “voluntary safety
consultations.”
The lack of adequate safety testing can be
seen in the letter FDA sends to the company
after completion of a “safety consultation
.”
For example, the letter sent to Monsanto on
September 25, 1996 about one of their first Bt-c
orn varieties, MON810,
states, “Based on the
safety and nutritional assessment you have conducted,
it is our understanding that Monsanto
has concluded that corn grain and forage deri
ved from the new variety are not materially
different in composition, safet
y, or other relevant parameters from corn grain and forage
currently on the market, and that they do no
t raise issues that would require premarket
review or approval by FDA” bold
added.
6
Note that FDA does not state its own opinion about
3
Hansen, M. 2000. Genetic engineering is not an extension of conventional plant breeding: How genetic
engineering differs from conventional breeding, hybridization, wide crosses and horizontal gene transfer. 13 pp.
At:
http://www.consumersunion.org/food/widecpi200.htm
4
Email from
WorldHealthOrganizationNews@who.int
to journalists dated July 9, 2011.
5
Pg. 22991 in FDA. Statement of Policy: Foods Derived From New Plant Varieties, May 29, 1992, Federal
Register vol. 57, No. 104. At:
http://www.fda.gov/Food/GuidanceComplianceRegulatoryI
nformation/GuidanceDocuments/Biotechnology/ucm096
095.htm
6
At:
http://www.fda.gov/Food/Biotechnology/Submissions/ucm161107.htm
3
the safety of this crop; it only st
ates what the company believes.
The letters for all 84 “safety
consultations” done since the Flavr Savr tomato
contain basically the same language. This
clearly shows that the FDA does not conduct safety assessments.
Other scientists have noted the lack of prope
r safety testing. For example, Dr. Belinda
Martineau, the scientist
who conducted the safety studies on th
e first GE plant, the Flavr Savr
tomato (engineered for long shelf life)
at Calgene, points out in her book
First Fruit: the
Creation of the Flavr Savr Tomato
and the Birth of Biotech Foods:
“Rather than personal
opinion, the scientific
community should give the public facts,
hard facts; the results of studies
that indicate these foods are sa
fe to eat and that growing them
on a large scale will not cause
environmental damage. Scientists and regulator
s throughout the ag biotec
h industry agree that
more public education about geneti
c engineering research is necessa
ry, but, thus far, few have
provided much information beyond how the technology works and the wondrous things that
might be done with it. . . .
And simply proclaiming that ‘these foods are safe and there is no
scientific evidence to the contrary’ is not
the same as saying ‘extensive tests have been
conducted and here are the results.’ In fact, w
ithout further elaboration,
‘no scientific evidence
to the contrary’ could be construed
as ‘no scientific
evidence, period
.’ ”
7
italics added.
Since the 1992 Statement of Policy on genetically engineered food, FDA has admitted
that its original policy was based on a false notion.
In 2001, the FDA proposed requiring
companies to notify the government at least 120 da
ys before commercializing a transgenic plant
variety. As part of that proposed
rule, the FDA admits that inse
rtional mutagenesis is a problem
and suggests requiring data on each separate
transformation event: "[B]ecause some rDNA-
induced unintended changes are sp
ecific to a transformational ev
ent (e.g. those resulting from
insertional mutagenesis), FDA belie
ves that it needs to be provided with information about foods
from all separate transformational events, ev
en when the agency has been provided with
information about foods from rDNA-modified plan
ts with the same intended trait and has had no
questions about such foods.
In contrast, the agency does not believe that it needs to receive
information about foods from plants derived through narrow crosses
[e.g. traditional breeding]"
italics added (FR 66(12), pg. 4711).
8
In other words, FDA has admitted that there is a difference
between GE and traditional bree
ding. In spite of this, FDA
is still following the 1992 policy
rather than the 2001 policy.
Global agreement has been reached on what constitutes proper safety assessment of foods
derived from GE plants, yet such suggested studie
s have not been carried
out on GE Bt corn (or
any other GE crop approved in the US). In 2003, the Codex Alimentarius
Ad Hoc
Task Force on
Foods Derived from Biotechnology reached agreem
ent on a “Guideline for the conduct of food
safety assessment of foods deri
ved from recombinant-DNA plants.”
9
This Guideline was
formally adopted by the full Codex Alimentari
us Commission in 2003, and was updated in 2008.
This is important because in the case of trade
disputes, the World Trade Organization considers
7
Pp. 232-233 in Martineau, B.
2001. First Fruit. McGraw-Hill.
8
Pg. 4711 in FDA. Premarket Notice Concerning Bioengineered Foods. Federal Register January 18, 2001.
Federal Register Vol. 51(12): pp. 4706 – 4738. At:
http://www.fda.gov/Food/GuidanceComplianceRegulatoryI
nformation/GuidanceDocuments/Biotechnology/ucm096
149.htm
9
See Codex Alimentarius Guideline 45. At:
http://www.codexalimentarius.ne
t/web/standard_list.do?lang=en
4
that, in terms of food safety, th
e standards or guidelines of C
odex Alimentarius are deemed the
global science-based standard and, thus, immune to
trade challenges, i.e. th
ey are not considered
to be a “non-tariff trade barrier.”
At present, none of the GE plants on sale in the US can meet
this standard.
Since the US does not require safety asse
ssments of GE plants, while the Codex
Alimentarius Guideline for the Conduct of F
ood Safety Assessment of Foods Derived from
Recombinant-DNA Plants states that such a f
ood safety assessment should be done, this means
the US cannot meet the global standards for safety assessment of GE foods. Consequently,
countries that require food safety assessments fo
r GE foods could block shipments of such GE
foods from the US without fear of losing a WTO challenge.
We believe that the US should require sa
fety assessments on foods derived from GE
organisms, and that those safety assessments s
hould be consistent with
the guidelines developed
by the Codex Alimentarius
Ad Hoc
Intergovernmental Task Force on Foods Derived from
Biotechnology so that US food products are not
potentially subject to a WTO challenge from
another country.
2.
Significant scientific uncertainty exists in th
e risk analysis of foods derived from GE
and this is recognized in the Codex.
In fact, the
Guideline for the Conduct of Food
Safety Assessment of Foods Derived from Recombinant-DNA Plants
has a whole section
on unintended effects which clearly states th
at they can have an unintended effect on
human health:
“Unintended effects due to genetic
modification may be subdivided into
two groups: those that are “predictable” and t
hose that are “unexpected” . . . A variety
of data and information are necessary to asse
ss unintended effects because no individual
test can detect all possible unint
ended effects or identify, with
certainty, those relevant to
human health.
”
10
italics added (paras 16 and 17, CAG/GL 45-2003). Furthermore, this
section recognizes that the unintended effects
could also be caused by changes in genes
that are expressed at the molecular level
and how the gene products are processed:
“Molecular biological and bioche
mical techniques (that) can also be used to analyze
potential changes at the level of gene tran
scription and message translation that could
lead to unintended effects”
(para 16, CAG/GL 45-2003).
3.
Labeling of GE food can serve as a risk ma
nagement measure to deal with scientific
uncertainty.
This would be consistent with th
e recommendations developed by the
Codex Alimentarius Ad Hoc Intergovernm
ental Task Force on Foods Derived from
Modern Biotechnology and adopted by the
Codex Alimentarius Commission in 2003.
The
Principles for the Risk Analysis of
Foods Derived from Modern Biotechnology
(CAC/GL 44—2003) clearly state th
at labeling can be used as a risk management option
to deal with scientific uncerta
inties associated with the ri
sk assessment of GE foods: “18.
Risk managers should take in
to account the uncertainties
in the risk assessment and
implement appropriate measures to manage
these uncertainties. 19. Risk management
10
pars 18, 19 in CAC/GL 44
—
2003. At:
http://www.codexalimentarius.net/web/standard_list.do?lang=en
5
measures may include, as appropriate, food
labeling, conditions for
market approval and
post
-
market monitoring.”
11
If there are unexpected adverse health effects
that happen as a result of GE, then labeling
could serve as a risk management mechanism that
would allow us to track such health problems
if they arose. If a food with
GE ingredients is not labeled as such, and that food causes an
adverse health effect, such as an allergic reaction, there would be virtually no way to determine
that the GE process was linked to the adverse
health effect. For example, suppose a company
decides to insert a synthetic gene, which code
s for a modified protein, into tomatoes. Suppose
that the novel protein causes a st
rong but delayed (say by 24 hours)
allergic reaction (e.g. serious
rash, upset stomach, or anaphylactic shock) in so
me relatively small subset of the population. To
start with, doctors would have an extremely di
fficult time identifying the
source of the problem.
If the offending tomato variety is not very prev
alent (i.e. does not have a large market share),
then the regular allergy test,
making a list of all foods eaten
in the last 24 hours, might not
uncover the tomato as the source of the problem
(the person would have to obtain and eat the
offending tomato variety a second time and get the same reaction). It might well take large
numbers of people being adversel
y affected and having the offendi
ng tomato variety be a large
share of the market before there would be
any hope of figuring out
what was causing the
problem.
Even if the food
has
undergone rigorous premarket safety
testing, scientific uncertainties
remain associated with the risk analysis. In
addition, when a large population (in the millions or
tens of millions) is exposed to a GE food, rare unexpected health problems can appear. Take the
case of Vioxx, a drug that was found to be safe in
premarket testing but had to be removed from
the market after adverse health effects were s
een when the drug was used by large numbers of
people. Because these drugs are labeled, doctors
are able to associate the unexpected health
problem with the specific drugs. With GE
foods, labeling would serve a similar purpose.
In addition to FDA not requiring any premarke
t safety testing, there is virtually no
independent safety testing of these crops in the
US due to intellectual property rights. When
farmers buy GE seed in the US, they invariably must sign a product stewardship agreement
which forbids them from giving such seeds to researchers.
12
In addition, researchers must get
permission from the biotech companies before
they can do research, which means there is a
paucity of independent research.
Scientists have even been threat
ened with legal action if they
revealed information obtained via freedom-of-information.
13
In early 2009
26 public sector
scientists in the US took the unprecedented step
of writing to the US Environmental Protection
Agency (EPA) protesting that
“
as a result of restricted access,
no truly independent research can
be legally conducted on many critical
questions regarding the technology
.”
14
As a result, the
editors of
Scientific American
published a perspec
tive stating that “
we also believe food safety
and environmental protection depe
nd on making plant products ava
ilable to regular scientific
scrutiny. Agricultural technology companies should
therefore immediately remove the restriction
11
At:
http://www.codexalimentarius.ne
t/web/standard_list.do?lang=en
12
Waltz, E. 2009. Under wraps.
Nature Biotechnology
, 27(10): 880-882. At:
http://www.emilywaltz.com/Biotech_cro
p_research_restric
tions_Oct_2009.pdf
13
IBID
14
http://www.scientificamerican.com
/article.cfm?id=do-seed-compan
ies-control-gm-crop-research
6
on research from their end-user agreements.
” We concur and believe
that only truly independent
safety tests will give us an answer about the safe
ty of GE foods. In the meantime, it’s crucial
that GE foods be labeled as a risk management
measure to deal with scientific uncertainty.
4.
We believe that consumers have a right to
know what is in the food they eat.
A
number of polls from 1995 to 2011 have
found that between 70% and 95% of people
polled supported mandatory labeling.
15
“
Information of materi
al importance” to
consumers is far broader than just “changes
in the organoleptic, nut
ritional or functional
properties” of a food. The fact that more
than 850,000 people have sent comments to the
FDA in support of a citizen’s
petition asking FDA to require
labeling of GE foods, shows
that consumers overwhelmingly want food fr
om GE sources to be labeled as such.
16
In
addition, on March 12, 2012, US Senator Barbar
a Boxer and Congressman Peter DeFazio
joined with 53 other Senate and House lawmak
ers in sending a letter urging the FDA to
require the labeling of GE foods.
17
FDA has tried to argue that they don’t have th
e authority to label GE
foods unless there is
a “material change” in the food, which FDA defines
as “change in the organoleptic, nutritional or
functional properties” of the food that is not obvi
ous to the consumer at the point of purchase.
We strongly disagree with
FDA and feel that they are trying
to ignore their own history. In the
past FDA has required labeling under the “material f
act” analysis that did
not entail a change in
nutritional value, organoleptic
properties, or functional char
acteristics of a food. FDA’s
authority to require labeling of all foods derives,
in part from section 201(n) and 403(a)(1) of the
Federal Food Drug and Cosmetic Act. A label is
considered “misleading” if it “fails to reveal
facts that are
material
in light of repres
entations made. . .”
bold
added. FDA articulated this
position in the 1986 final rule that required labe
ling of irradiated foods, even though the FDA
had ruled that irradiated foods we
re safe. FDA stated in this fina
l rule on food irradiation that the
large number of respondents who asked for labeli
ng of retail products was
one factor indicative
of the materiality of
food irradiation: “
Whether information is material under section 201(n) of
the act depends not on the abstract worth of th
e information but on whether consumers view
such information as important and whether the
omission of label information may mislead a
consumer. The large number of consumer commen
ts requesting retail labeling attest to the
significance placed on such labeling by consumers
”
18
emphasis added.
Thus, materiality
clearly does not always include “some change
in nutritional value, or
ganoleptic properties,
or functional characteristics
” of the food.
Material facts other than ma
terial changes have long been
required for other reasons that
are important to consumers. Labeling the source
of protein hydrolysates was required because of
the concern of vegetarians and observant Jews
and Muslims. As the FDA stated, “the food
source of a protein hydrolysate is
information of material importa
nce for a person who desires to
avoid certain foods for religious or cultural reasons.”
19
Thus, “information of material
15
http://gefoodlabels.org/gmo-labeling/polls-on-gmo-labeling/
16
http://gefoodlabels.org/
17
IBID
18
Pg. 13380. FDA. Final Rule on Food Irradiation. Federal Register April 18, 1986, Federal Register, Vol. 51, pg.
13376
19
56 FR 28592 [1991]
7
importance” to a consumer is not simply restrict
ed to “information about the characteristics of a
food.”
In 2007, FDA proposed a revision to their labeling requirements for irradiated foods,
such that labeling would only be
required on those irradiated foods
in which the irradiation has
lead to a “material change”—defi
ned as a “change in the organolep
tic, nutritional or functional
properties”—in the food that is
not obvious to the consumer at th
e point of purchase. Thus, not
all irradiated food would be required to be labe
led. This proposed revi
sion to the irradiation
labeling standard went nowhere. However, th
is attempted weakening
of the food irradiation
labeling standard clearly demonstrates that
FDA is now trying to narrow the concept of
“materiality,” so as to av
oid the labeling of GE foods.
A number of recent scientific studies have
pointed out unexpected effects in genetically
engineered crops and have shown that they can
lead to potential adverse health effects:
•
GE plant materials are finding their way into the human body.
A study done
by Canadian scientists an
d published last year was
very disturbing. The study
involved 30 pregnant an
d 39 non-pregnant women in Quebec, Canada.
20
Blood
was taken from women and from fetal cord
blood and tested for 3 pesticides
associated with GM: glyphosate, gluf
osinate, and Cry1Ab. The surprising
finding was that Cry1Ab was detected in
93% and 80% of maternal and fetal
blood samples, respectively and in 69% of
tested blood samples from nonpregnant
women. The scientists noted that “t
race amounts of the Cry1Ab toxin were
detected in the gastrointestinal conten
ts of livestock fed on GM corn, raising
concerns about this toxin in insect-resist
ant GM crops; [suggesting] (1) that these
toxins may not be effectively eliminated in humans and (2) there may be a high
risk of exposure through cons
umption of contaminated meat.”
21
They concluded,
“To our knowledge, this is the first study to
highlight the presence of pesticides-
associated genetically modified foods in
maternal, fetal and
nonpregnant women’s
blood. 3-MPPA and Cry1Ab toxins are clearly
detectable and appear to cross the
placenta to the fetus. Given the poten
tial toxicity of these environmental
pollutants and the fragility of the fetus, mo
re studies are needed, particularly those
using the placental transfer approach.”
22
•
A major food safety concern fo
r GE plants is allergenicity.
In 2001, the report
of a Joint Food and Agriculture Orga
nization/World Health Organization
(FAO/WHO) Expert Consultation on A
llergenicity of Foods Derived from
Biotechnology, held at WHO h
eadquarters in Rome, laid out a detailed protocol (a
decision tree) for evaluating th
e allergenicity of GE foods.
23
None of the GE
20
Aris, A and S Leblanc. 2011. Maternal and fetal exposure
to pesticides associated to
genetically modified foods
in Eastern Townships of Quebec, Canada.
Reproductive Toxicology
, 31(4): 528-533.
21
Pg. 533 in Aris, A and S Leblanc. 2011. Maternal and
fetal exposure to pesticides associated to genetically
modified foods in Eastern Townships of Quebec, Canada.
Reproductive Toxicology
, 31(4): 528-533.
22
IBID
23
FAO/WHO. 2001. Evaluation of Allergenicity of Ge
netically Modified Foods.
Report of a Joint FAO/WHO
Expert Consultation on Allergenicity of Foods Derived from Biotechnology, January 22-25, 2001. Rome, Italy. At:
ftp://ftp.fao.org/es/esn/food/allergygm.pdf
8
crops, including GE corn, on the market in
the U.S. have been assessed using such
a protocol.
•
Various types of scientific evidence
suggest that Bt corn may contain a
transgenic allergen.
Bt corn contains various modi
fied endotoxins from the soil
bacterium
Bacillus thuringiensis
(Bt). These
δ
-endotoxins are called Cry
proteins, in particular Cr
y1Ab or Cry1Ac. A study of farmworkers who worked
in onion fields where foliar Bt sprays we
re used found that 2 of them contained
antibodies to the
δ
-endotoxins, Cry1Ab and/or Cry1Ac, consistent with an
allergy.
24
A survey of Bt cotton farmers in India done by local doctors found that
numerous Bt cotton farmers, as well
as workers in a ginning factory, had
symptoms consistent with an allergic r
eaction to Bt cotton within a year of the
introduction of Bt cotton in the region.
25
•
One of the endotoxins found in GE co
rn, Cry1Ac, has been found to have
sequence similarity to
a known human allergen.
One of the first steps in
assessing the allergic potent
ial of a protein (most alle
rgens are proteins) is to
determine if it has similarity in amino acid sequence to a known allergen. A
paper published in 1998 by the head of FD
A’s own biotechnology studies branch,
Dr. Steven Gendel, found significant am
ino acid sequence similarity between
Cry1Ab and Cry1Ac (found in Bt maize and Bt
cotton) and vitellogenin, the main
precursor to egg yolk protei
n and a known allergen, as
well as between Cry3A (Bt
potatoes) and
β
-lactoglobulin, a major milk allergen.
26
•
Scientific studies also show Cry1Ac has
a strong effect on the immune system
as well as being a potent adjuvant.
A series of five studies
carried out by a team
of scientists from two Mexican universiti
es and from Cuba have suggested that
the Cry1Ac protein has immunogenic and al
lergenic properties. A mouse study
demonstrated that the Cry1Ac was a poten
t systemic and mucosal adjuvant: “We
conclude that Cry1Ac is a mucosal and
systemic adjuvant as potent as CT
[cholera toxin] which enhances mostly serum and intestinal IgG antibody
responses”.
27
Another mouse study which furthe
r characterized the mucosal and
systemic immune response induced in mice “confirm[ed] that the Cry1Ac
protoxin is a potent immunogen able to i
nduce a specific immune response in the
mucosal tissue
, which has not been observed in
response to most other proteins
”
24
Bernstein, I.L., Bernstein, J.A., Mille
r, M., Tierzieva, S., Bernstein, D.I.
, Lummus, Z., Selgrade, M.K., Doerfler,
D.L. and V.L. Seligy. 1999. Immune responses in farm workers after exposure to
Bacillus thuringiensis
pesticides.
Environmental Health Perspectives
, 107(7): 575-582. At:
http://www.ncbi.nlm.nih.gov/pmc/article
s/PMC1566654/pdf/envhper00512-0103.pdf
25
Gupta, A. et al. 2006. Impact of
Bt cotton on farmers’ health (in Barwani
and Dhar District of Madhya Pradesh).
At:
http://www.lobbywatch.org/archive2.asp?arcid=6265
and
http://www.lobbywatch.org/archive2.asp?arcid=6266
26
Gendel, S.M. 1998. The use of amino acid sequence alignments to assess potential allergenicity of proteins used
in genetically modified foods.
Advances in Food and Nutrition Research,
42: 44-61.
27
Vazquez-Padron, R.I., More
no-Fierros, L., Neri-Bazan, L., de la Ri
va, G.A. and R. Lopez-Revilla. 1999.
Bacillus thuringiensis Cry1Ac protoxin is a potent systemic and mucosal adjuvant.
Scandinavian Journal of
Immunology
49: 578-584.
9
italics added.
28
Another study concluded, “We think that previous to
commercialization of food elaborated with
self-insecticide transgenic plants it is
necessary to perform toxocological test
s to demonstrate the safety of Cry1A
proteins for the mucosal tissue and for
the immunological system of animals.”
29
Such tests have never been carried out on GE Bt-corn.
•
Corn allergen gene turned on
as result of genetic engineering.
A carefully
designed study involved growing Monsanto
’s Bt corn varieties, MON 810, in a
growth chamber along with its
near isoline (corn vari
ety engineered to produce
MON 810). Since MON 810 and its near
isoline are grow
n in the same
environment, the only difference in the plants
will be due to the effect of genetic
engineering. This was a proteomic
study, which is a study of the expressed
proteins, not just of the pr
otein(s) expressed as a re
sult of genetic engineering.
Proteomic studies are a good way to dete
ct unintended effects associated with
genetic engineering, particularly the disr
uptive effects due to the random insertion
of a transgene. The study found that
43 proteins in the MON 810 plants were
significantly disrupted, compared to the non-
GE near isoline.
As the study notes,
“a newly expressed spot (SSP 6711) corresponding to a 50 dDa gamma zein, a
well-known corn allergenic protein, has b
een detected. Moreover, as a major
concern, a number of seed storage prot
eins (such as globulins and vicilin-like
embryo storage proteins) exhibited tr
uncated forms having molecular masses
significantly lower than the native ones.”
30
The safety implications of the
truncated seed storage proteins are
unknown, as no feeding study was done. So,
this study demonstrates that the process
of genetic engineering turned on a known
corn allergen gene that is normally turned off as well as caused changes to the
main proteins found in the seed.
•
Bt corn may cause adverse effects on
gut and peripheral immune response.
A carefully designed study (MON 810 and n
ear isoline grown simultaneously in
neighboring fields in Landri
ano, Italy, to control for environmental effects) done
by Italian scientists invo
lved feeding a diet cont
aining MON 810 or its near
isoline to mice in vulnerable conditions, e.g. weaning and old mice, and looking
at a variety of measures of the gut an
d peripheral immune response. The main
finding was that “compared to the co
ntrol maize, MON810 maize induced
alterations in the percentage of
T and B cells and of CD4+, CD8+,
γδ
T, and
α
β
T
subpopulations of weaning and old mice fed
for 30 or 90 days, respectively, at the
gut and peripheral sites. An increase
of serum IL-6, IL-13, IL-12p70, and MIP-1
β
28
Pg. 147 in Vazquez-Padron, R.I., Mo
reno-Fierros, L., Neri-Bazan, L., Martin
ez-Gil, A.F., de-la-Riva, G.A., and
R. Lopez-Revilla. 2000a. Character
ization of the mucosal and systemic immune response induced by Cry1Ac
protein from
Bacillus thuringiensis
HD 73 in mice.
Brazilian Journal of Medical and Biological Research
33: 147-
155.
29
Pg. 58 in Vazquez-Padron, R.I., Mo
reno-Fierros, L., Neri-Bazan, L., Martinez-
Gil, A.F., de-la-Riva, G.A., and R.
Lopez-Revilla. 2000a. Characterization of the mucosal an
d systemic immune response induced by Cry1Ac protein
from
Bacillus thuringiensis
HD 73 in mice.
Brazilian Journal of Medical and Biological Research
33: 147-155.
30
Pg. 1855 in Zolla, L., Rinalducci, S.,
Antonioli, P and P.G. Righetti. 2008.
Proteomics as a complementary tool
for identifying unintended side effects occurring in transg
enic maize seeds as a result of genetic modifications.
Journal of Proteome Research,
7: 1850-1861. At:
http://stopogm.net/webfm_send/288
10
after MON810 feeding was also found.
These results suggest the importance of
the gut and peripheral immune response to GM crop ingestion as well as the
age of the consumer in the GMO safety evaluation
”
bold
added.
31
•
A meta
-
analysis of feeding studies invol
ving GE crops suggests health
problems and that longer term studies are needed.
A carefully designed meta-
analysis was done of 19 published studies involving mammals fed GE corn or
soy.
32
The meta-analysis also included the
raw data from a number of 90-day-
long feeding studies that we
re obtained as a result of
court action or official
requests. The data included biochemical
blood and urine parameters of mammals
eating GE crops with numerous organ weights and histopathology findings.
meta-analysis of all the
in vivo
studies found that the ma
jority of statistically
significant results came from parameters
involving the live
r or kidney. The
authors conclude that longer-duration te
sts are needed, noting that “90-d
tests are insufficient to evaluate chronic
toxicity, and the signs highlighted in the
kidneys and livers could be
the onset of chronic diseases. However, no minimal
length for the tests is yet obligatory fo
r any of the GMOs cultivated on a large
scale, and this is socially unacceptable in
terms of consumer health protec
We are suggesting that th
e studies should be improved and prolonged, as well as
being made compulsory, and that the se
xual hormones should be assessed too
moreover, reproductive and multigenerat
ional studies ought to be conducted
too.”
The
ay-long
tion.
, and
33
•
A 2005 animal study on transgenic peas
found that the genetic engineering
process unexpectedly turned a protein that
is relatively “safe” into one that
causes adverse health effects and increa
sed the potential for adverse effects
in other proteins
.
34
A group of Australian scientists
looked at the transfer of a
gene from beans into peas. The gene
codes for a protein, a-amylase inhibitor
(aAI), that confers resistance to cert
ain weevil pests. The aAI in raw beans
inhibits the action of amylase, an enzyme
that degrades starch. So aAI in raw
beans can cause gastrointestinal problems
in humans. When beans are cooked, the
aAI is easily digested and
causes no problems. However, when the gene for aAI
was inserted into peas, the resultant prot
ein had the same amino acid sequence as
the bean aAI, yet the struct
ure of the protein had been
subtly altered (through a
process called post-translational processi
ng), causing an immunological reaction
in mice fed the transgenic peas, but not in mice fed normal beans. The
31
Pg. 11533 in Finamore, A., Roselli, M., Britti, S., Monastra
, G., Ambra, R., Turrini, A. and E. Mengheri. 2008.
Intestinal and peripheral immune response to MON810 maize ingestion in weaning and old mice.
Journal of
Agriculture and Food Chemistry
, 56: 11533-11539. At:
http://www.giovannimonastra.info/documenti_pdf/Monastra_J_Agr_Food_Chem_2.pdf
32
Séralini, G-E, Mesnage, R., Clair, E., Gress, S., de
Vendômois, JS and D. Cellier. Genetically modified crops
safety assessments: present limits and possible improvements.
Environmental Sciences Europe
, 23: 10. At:
http://www.enveurope.com/content/pdf/2190-4715-23-10.pdf
33
Pg. 1 in IBID
34
Prescott, VE, Campbell, PM, Moore, A, Mattes, J, Rothenberg, ME, Foster, PS, Higgins, TJV and SP Hogan.
2005. Transgenic expression of bean
α
-amylase inhibitor in peas results in altered structure and immunogenicity.
Journal of Agricultural and Food Chemistry
, 53: 9023-9030.
11
adverse/immunological reaction to the tr
ansgenic pea aAI was not mitigated by
boiling the peas. The mice fed transgenic
peas, in addition to developing an
immunological reaction to th
e pea aAI, also developed an immunological reaction
to a number of proteins normally found
in peas; mice fed these same proteins
from non-engineered peas developed a fa
r smaller immunological response, thus
demonstrating that the transgenic pea aA
I acts as an adjuvant to increase the
immunogenicity of native pea proteins.
This new study involving aAI is extremely important. This study found that
moving the same gene between two rela
tively closely related plants (common
beans and peas) can result in a protein th
at, although it contains the exact same
amino acid sequence, is relatively safe in
the donor plant (common beans), but is
potentially harmful in the recipient plan
t (peas) and can increase the potential
hazardousness of other proteins found in
peas. These are all clearly unintended
and unexpected effects that clearly re
sult in an adverse health effect.
•
New data confirm unintended and unexpected effect from genetic
engineering.
Other studies in the last 5 years have found all sorts of unexpected
changes/effects in GE crops. A detailed mo
lecular characterization of various GE
crops (three differe
nt Bt maizes, an herbicide-
tolerant maize, RoundUp Ready
soybean, and a male-sterile canola) curren
tly on the market, done in Belgium, has
shown that of the transgenic lines look
ed at, all but one were found to have
differences in the molecular characteriza
tion in products on the market compared
to the original structure reported by the company.
35
Except for the canola, all
these reports found that the structure
(e.g. molecular characterization) of
transgenic inserts as reported by the co
mpanies in their initial submission were
different than the structure found in s
ubsequent studies. The differences in
structure involved rearranged inserts, partial copies of genes inserted, multiple
copies of transgenes inserted, scra
mbling of DNA near the border of the
transgenic inserts, etc., suggesting that
the transgenic lines are unstable and/or
more likely to result in unintended effects.
In fact, in virtually all the cases, the
SBB/IPH recommends that further analys
is “should be done to determine the
presence of chimaeric open reading fram
es in the border inte
gration sequences”,
e.g. an analysis should be done to see if
there are any unexpect
ed proteins being
produced.
•
A paper reviewing the food safety i
ssues associated with genetically
engineered crops listed a range of
documented unintended effects
and
concluded that “The development and va
lidation of new profiling methods such
35
Dr. Moens, with the Service of Biosafety and Biotechnology (SBB) of the Scientific In
stitute of Public Health
(IPH), a government agency reported on
the molecular characterization of the genetic map for six transgenic crops:
3 different Bt maizes—Bt 176, Syngenta (
www.biosafety.be/TP/MGC_reports/Report_Bt176.pdf
); MON 810,
Monsanto (
www.biosafety.be/TP/MGC_reports/Report_MON810.pdf
); Bt11, NorthrupKing
(
www.biosafety.be/TP/MGC_reports/Report_Bt11.pdf
)—a herbicide tolerant maize (LibertyLink maize, Bayer)(
www.biosafety.be/TP/MGC_reports/Report_T25.pdf
) , glyphosate tolerant soybeans (RoundUp Ready soybeans,
Monsanto) (
www.biosafety.be/TP/MGC_reports/Report_MON810.pdf
) , and a canola engineered for male sterility
(Ms8 x Rf3, Bayer Cropscience)
12
as DNA microarray technology, proteo
mics, and metabolomics for the
identification and characterization of uni
ntended effects, which may occur as a
result of the genetic modification, is recommended.”
36
•
An Annex to the Codex Plant Guideline on the assessment of possible
allergenicity states that
no definitive test exists to accurately predict
allergenicity of a given protein:
“At present, there is no
definitive test that can
be relied upon to predict allergic re
sponse in humans to a newly expressed
protein.”
37
So there is scientific uncerta
inty around assessment of potential
allergenicity of foods derived from GE
/GM. Furthermore, a study done by Dutch
scientists, using a modified, and more
conservative, methodology for screening
transgenic proteins for potential allerg
enicity (e.g. the analysis of sequence
homology to known food and environmental
allergens) as laid out in the Joint
FAO/WHO Expert Consulta
tion on Allergenicity of Foods Derived from
Biotechnology (January, 2001), found that a
number of transgenic proteins have
significant sequence homology to known
allergens and recommended further
study for a number of these proteins: “Ma
ny transgenic proteins have identical
stretches of six or seven amino acids in
common with allergenic proteins. Most
identical stretches are likely to be false
positives. As shown in this study, identical
stretches can be further sc
reened for relevance by comparison with linear IgE-
binding epitopes described in the literature
. In the absence of literature values on
epitopes, antigenicity prediction by com
puter aids to select potential antibody
binding sites that will need verifica
tion of IgE binding by sera tests.
Finally, the
positive outcomes of this approach warrant
[papaya ringspot virus coat protein,
acetolactate synthase GH50, and glyphosate oxidoreductase]
further clinical
testing for potential allergenicity”
38
-
bold
added. Another study done by Dr.
Steven Gendel of the US Food and Dr
ug Administration f
ound that there was
significant sequence similarity between a
gene in Bt maize and Bt cotton (e.g.
Cry1Ab or Cry1Ac) and an egg yolk alle
rgen and recommended further study:
“the similarity between Cry1A(b) and vite
llogenin might be sufficient to warrant
additional evaluation.”
39
While science demonstrates the need to track
potential health impacts of genetically
engineered food, there is also br
oad support for labeling genetically
engineered food as indicated
by the following endorsements by the public
health, nursing, medical and healthcare
communities:
•
In 2001, the American Public He
alth Association passed a re
solution entitled Support of
the Labeling of Genetically Modified F
oods which “Resolves that APHA declare its
36
Pg. 503 in Kuiper, HA, Kleter, GA, Notebom, HPJM and EJ
Kok. 2001. Assessment of f
ood safety issues related
to genetically modified foods.
The Plant Journal
, 27(6): 503-528.
37
para 2, Annex, CAG/GL 45-2003. At: :
http://www.codexalimentarius.ne
t/web/standard_list.do?lang=en
38
Pg. 1 in: Kleter, GA and ACM Peijnenburg. 2002. Screeni
ng of transgenic proteins expressed in transgenic food
crops for the presence of short amino acid sequences iden
tical to potential, IgE – binding linear epitopes of
allergens.
BMC Structural Biology,
2:8. Accessed at
http://www.biomedcentral.com/1472-6807/2/8
39
Pg. 44 in Gendel, S.M. 1998. The use of amino acid
sequence alignments to assess potential allergenicity of
proteins used in genetically modified foods.
Advances in Food and Nutrition Research,
42: 44-61.
13
s
upport that any food product containing ge
netically modified organisms be so
labeled.”
40
•
In 2008, the American Nurses Association
adopted a resolution
on Healthy Food in
t of
•
In 2011, the Illinois Public Health Asso
ciation adopted a resolution supporting
•
atholic Healthcare West (a network of 41 hospitals and 10,000 physicians) avoids
g of
Furthermore, twenty state legislatures have
introduced bills to require mandatory labeling
of GE f
H
ealth Care, which specifically, “Supports th
e public’s right to know through suppor
appropriate food labeling including country
-of-origin and genetic modification...”
41
“
legislation and/or regulati
ons that require clearly la
beling food with genetically
engineered ingredients.”
42
C
g
enetically engineered food and advocates for
public policies that in
clude the labelin
genetically engineered food.
43
oods.
(IL, AK, CA, NC, IA, MD, NY, OR, RI
, WV, VT, TN, HI, CT, MA, MO, NJ,
WA, MI, NH).
40
American Public Health Association Policy Statemen
t Database. “Support of the Labeling of Genetically
Modified Foods.”
Available from:
http://www.apha.org/advocacy/polic
y/policysearch/default.htm?id=250
41
House of Delegates Resolution: “Healthy food in health
care.” Silver Spring, MD: Am
erican Nurses Association.
2008. Available from:
http://www.nursingworld.org/MemberCenterCategories/ANAGovernance/HODArchives/2008HOD/ActionsAdopte
d/HealthyFoodinHealthCare.aspx
42
At:
http://www.ipha.com/Public/ContentAr
ticle.aspx?type=Policy_Resolution
43
Catholic Healthcare West. “Catholic Healthcare West
Presses Suppliers to Prohibit Animal Cloning and
Genetically Engineered Foods.” Available from:
http://www.chwhealth.org/stellent/groups/public/@xinternet_con_sys/
documents/webcontent/194274.pdf
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