3-Food: MON 863 maize 90-day rat feeding study design and conduct fact sheet
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------------------------------- GENET-news -------------------------------
TITLE: MON 863 Maize 90-Day Rat Feeding Study Design and Conduct Fact Sheet
SOURCE: Monsanto UK
DATE: 17 Apr 2005
------------------ archive: http://www.genet-info.org/ ------------------
MON 863 Maize 90-Day Rat Feeding Study Design and Conduct Fact Sheet
MON 863 is a genetically modified maize product that provides control of the
corn rootworm pest. The safety of MON 863 maize has been established in
Europe by the German authority (RKI), the European Food Standards Authority
(EFSA), the French food agency (AFSSA), and most recently by the French
Commission du Génie Biomoléculaire (CGB). A 90-day rat feeding study was
conducted as part of the comprehensive safety assessment to confirm the
safety of MON 863 grain. Dr. Arpad Pusztai has recently evaluated the
90-day rat feeding study and concluded the study is flawed. In contrast to
Dr. Pusztai's opinion, the aforementioned regulatory experts who reviewed
this study concluded that it was appropriately designed and conducted, and
the results support the safety of MON 863 for human and animal consumption.
The 90-day MON 863 rat feeding study was conducted at an independent
toxicology facility, Covance Laboratories, Inc. This laboratory is
internationally recognized and routinely inspected by government regulatory
authorities for compliance with Good Laboratory Practice standards. The
study design followed internationally recognized (OECD) toxicology testing
guidelines developed by a diverse group of experts using a science-based
approach to ensure wide acceptability of these studies for regulatory
purposes. The study conduct also adhered to OECD Good Laboratory Practice
Regulations, thereby assuring data quality and accuracy.
The identity of MON 863, parental control, and reference maize grain was
preserved by following Good Field Production Practices. In addition, PCR
analysis was also used to confirm the identity of the test grain and its
absence in parental control grain. Diets containing MON 863, parental
control and reference grain were prepared by Purina Mills Inc. and
nutritionally balanced to meet Purina specifications for certified diets.
Purina Mills manufactures high quality animal diets for toxicology and
research laboratories around the world.
The study included 400 rats divided into 10 groups of 20 male and female
animals/group fed diets containing either MON 863 or control grain. During
the course of the study, more than 900 statistical comparisons were made
between test and control animals for the parameters that were measured.
Based on chance alone, several statistically significant differences were
expected that were not biologically meaningful. The results were reviewed
by toxicology experts at Covance, the German RKI (rapporteur country), the
Member States, EFSA, and independent toxicology experts from New Zealand,
Italy, Germany, and England. All of these experts concluded that the
statistical differences resulted from normal fluctuations that occur in rat
studies, were not clinically related, and thus not biologically meaningful.
Questions regarding the biological relevance of a few kidney pathology
findings observed in male rats were independently reviewed a second time by
expert pathologists who confirmed the conclusions of the Covance pathologist
and EFSA that the findings were normal for rats and not related to MON 863.
In summary, the 90-day rat feeding study with MON 863 followed a harmonized,
scientifically-based experimental design as specified in OECD guidelines as
well as Good Laboratory Practices to insure the quality of the data.
Independent scientists in Europe have concluded the study was appropriately
conducted according to internationally accepted methods, and found no
evidence of harmful effects of MON 863 maize. After a thorough analysis of
study methodology and results, European regulatory authorities have
concluded that MON 863 will have "no adverse effects on human or animal
health." The safety of MON 863 grain has also been confirmed by other
regulatory authorities in the US, Canada, Japan, Korea, Taiwan, the
Philippines, Russia, Australia/New Zealand and Mexico.
Corn rootworm larvae damage maize by feeding on the roots, reducing the
ability of the plant to absorb water and nutrients from soil and causing
harvesting difficulties due to plant lodging. The US Department of
Agriculture estimates that this pest causes $1 billion in lost revenue
annually to the US maize crop. An estimated 5.7 million hectares of maize
in the US are treated annually with chemical insecticides to control this
What is MON 863 YieldGard(R) Rootworm maize?
As an alternative to chemical insecticides, YieldGard(R) Rootworm contains a
protein from Bacillus thuringiensis (Bt), a common soil microbe that
specifically targets corn rootworm larvae, allowing the corn plant to
naturally protect its roots against the damaging corn rootworm.
The use of biological insect control is more environmentally sustainable
than the use of pesticides. Bt proteins have been used for pest control for
more than 40 years by farmers worldwide, including organic farmers.
MON863 YieldGard(R) Rootworm has been grown commercially in the United
States and Canada since 2003, and has been approved for import and food use
in many countries around the world, including Japan, Korea, Taiwan, the
Philippines, Russia and Mexico.
Details on MON 863 maize can be found at
Regulatory status of MON 863 maize in the EU Regulatory approval for the
import and use of biotech crops in the EU requires a number of steps
involving review by more than one hundred independent scientists acting on
behalf of the European Commission and Member States' governments. The
regulatory steps that MON 863 has undergone in the EU are described below.
In July 2002, Monsanto submitted an application for import of MON 863 maize
(excluding cultivation) under Directive 90/220/EEC to Germany, the country
acting as Rapporteur for this file. This submission, which contained the
Rat 90-day Subchronic Dietary Feeding Study conducted by a third party (1),
was then updated to fulfill the new 2001/18/EC requirements. Germany issued
a positive Initial Assessment Report (2), which was forwarded to the EU
Member States for review in April 2003.
In parallel, the application was opened for public review and comment on 05
Monsanto submitted an application under the novel food and novel food
ingredients Regulation (EC) N° 258/97, also to Germany as lead Member
State, in July 2002. Germany issued an Initial Assessment Report, which was
forwarded to the EU Member States for review in June 2003. Answers to
additional questions, comments and reasoned objections from some Member
States were submitted to all Member States in September 2003.
In order to provide further independent assessment, Monsanto commissioned a
formal Study and Pathology, Peer review (7). This was a voluntary activity
on behalf of Monsanto in which two highly experienced independent
veterinary pathologists, one having particular expertise in relation to
renal histopathology, conducted a Peer Review of this study to arrive at a
scientific consensus on whether there were any toxicologically significant
findings in this study. After detailed review and discussion, the experts
concluded, consistent with the original report, "that dietary
administration of MON 863 corn did not induce toxic effects in the kidneys
The European Foods Standards Authority (EFSA) evaluated the complete dossier
and adopted a positive scientific opinion on 02 April 2004, concluding, "the
placing on the market of MON 863 is unlikely to have an adverse effect on
human and animal health or the environment in the context of its proposed
use." (http://www.efsa.eu.int/) (3).
Regulators at some Member States raised questions about the studies
submitted as part of Monsanto's applications, and this is a normal part of
the regulatory process. Monsanto has addressed these questions and
performed additional scientific analysis as necessary. As a result,
European competent authorities now concur that MON 863 YieldGard Rootworm
maize is as safe as conventional maize for human and animal health and the
The next stage in the process is a vote on MON 863 by EU Member States.
Chronology and Summary of opinions on OECD 408.
Rat 90-day Dietary Feeding Study Covance 90 Day Rat Dietary Subchronic
Comparison Study with MON 863 Corn in Rats Covance Study No. 6l03-293 17th
"Toxicological parameters evaluated were survival, clinical signs, body
weights, food consumption, clinical pathology, organ weights, and
macroscopic and microscopic pathology. There were no test article related
changes in any of the aforementioned toxicological parameters. The response
of rats fed either 11 or 33% w/w corn event MON 863 in the diet was
comparable to rats fed diets containing the nontransgenic control line
LH82xA634 and corn from six commercial nontransgenic reference control
Assessment Report of the Robert Koch Institut in Accordance with Directive
2001/18/EC 8th April 2003
See Section 18.104.22.168 Feeding Studies using MON 863 Maize Kernels - Subchronic
Feeding Study "From this extensive study, it can be deduced that even after
long-term oral exposure to MON 863 Maize Kernels no harmful effects are to
EFSA - Novel Food Assessment 258/97 Opinion 02/04/2004
"MON 863 will not have an adverse effect on human and animal health."
EFSA - Directive 2001/18.EC Press Release 19/04/2004
MON 863 "as safe as conventional maize'
AFSSA (French Food Safety Agency) 2nd December 2003
Stated, "...equivalence in chemical and nutritional composition" of MON 863
with comparable varieties, and that "the human consumption of grains and
products derived from MON 863 maize, does not pose any nutritional risk."
CGB 28/10/2003 05/11/2003 CGB requested more precise interpretation of
"In the absence of additional confirmatory studies, [...] the committee of
the CGB is not able to definitively conclude on the absence of any risk to
Monsanto 24/05/2004 Supplemental analysis in response to CGB request
"...the weight of evidence supports a conclusion that there are no MON 863
induced adverse effects..."
Pathology Peer Review - Seventh Wave - 003 - RS-04 Retrospective Evaluation
of Renal Tissues and data from Monsanto Co. Study CV - 2000 - 260 (MSL
18175): a 13 week Rat Feeding Study with MON 863 Corn 11/08/2004 Peer
Review in response to CGB request
"...that dietary administration of MON 863 com did not induce toxic effects
in the kidneys of rats"
(1) 13 week Dietary Subchronic Comparison Study with MON 863 Corn in Rats
Preceded by a 1 - Week Baseline Food Consumption Determination with PMI
Certified Rodent Diet #5002. (OECD Protocol 408) Covance Study No.
6l03-293, issued 17th December 2002
(2) Assessment Report of the Robert Koch Institut in Accordance with
Directive 2001/18/EC, Insect -Resistant Maize MON 863 and MON 863 x MON
810, 8th April 2003 (draft translation);
Assessment Report PDF file
(3) Opinion of the Scientific Panel on Genetically Modified Organisms on a
request from the Commission related to the safety of foods and food
ingredients derived from insect-protected genetically modified maize MON
863 and MON 863 x MON 810, for which a request for placing on the market
was submitted under Article 4 of the Novel Food Regulation (EC) No 258/97
by Monsanto (Question No EFSA - Q - 2003 - 121) Opinion Adopted on 2nd
(3a) Opinion of the Scientific Panel on Genetically Modified Organisms on a
request from the Commission related to the Notification (Reference
C/DE/02/9) for the placing on the market of insect-protected genetically
modified maize MON 863 and MON 863 x MON 810, for import and processing,
under Part C of Directive 2001/18/EC from Monsanto (Question No
EFSA-Q-2003-089) Opinion Adopted on 2nd April 2004
(4) AFSSA (French Food Safety Agency) Opinion dated 2nd December 2003
(5) CGB (Commission du Genie Biomoleculaire) Opinion dated 28th October 2003
(6) Supplemental Analysis of Selected Findings on the Rat 90-day Feeding
Study with MON 863 Maize, Report MSL - 18175; Hammond, B.G. and Ward, D.P.,
Monsanto Co., USA, 24th May 2004
(7) Retrospective Evaluation of Renal Tissues and data from Monsanto Co.
Study CV - 2000 - 260 (MSL 18175): a 13 week Rat Feeding Study with MON 863
Corn, (Covance Laboratories Study No 6103-293)
European NGO Network on Genetic Engineering
Hartmut MEYER (Mr)
In den Steinaeckern 13
D - 38116 Braunschweig
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