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[SANET-MG] LLRICE601 petition comments
Hope more people will make comments to USDA/APHIS!
USDA Poised to Deregulate Illegal GM Rice
Questions over USDA’s Role in Transgenic Contamination and Regulation
Prof. Joe Cummins and Dr. Mae-Wan Ho
This article was submitted to the USDA on behalf of ISIS. Please
circulate widely to your regulators and tell the USDA you support this
submission
USDA announced expedited approval of Illegal GM rice
Bayer CropScience has filed a request to the United States Department of
Agriculture Animal and Plant Health Inspection Service (USDA/APHIS) for
non-regulated status for rice with glufosinate herbicide-tolerant event
LLRICE601 and any progeny derived from crosses of this event with
traditional rice varieties [1]. It is seeking retroactive approval for a
transgenic rice variety that has escaped from test plots into commercial
rice in the United States and exported to the rest of the world. This
has resulted in a virtual collapse of the US rice industry as bans and
quarantines were promptly imposed by importing countries, while several
lawsuits have been filed by rice farmers against Bayer in the US [2 3],
and USDA has responded by announcing an expedited approval process for
the rice strain.
USDA/APHIS has opened the Bayer proposal for public comment, and
provided background documents on the proposal. In fact, USDA/AHIS has
even prepared an environmental assessment on Bayer’s behalf [4], “for a
preliminary decision to extend a determination of non-regulated status.”
Bayer CropScience’s request for the extension of LLRICE601 is “based on
its similarity to previously deregulated rice lines, LLRICE62 and LLRICE06.”
All comments must be received on or before 10 October 2006, to be filed
under APHIS-2006-0140, which can be accessed electronically at:
http://www.regulations.gov/fdmspublic/component/main
Extensive “confidential business information” concealed from the public
About a third of the LLRICE601 petition was left blank under
“confidential business information” (CBI). This is far from consistent
with the scientific requirement for full and truthful reporting. None of
the previous petitions for un-regulated status have such extensive
designation of CBI, and apparently some of the CBI information has been
openly reported previously, and it is clear that USDA/APHIS is not
normally required to accept frivolous CBI designations.
Extension of unregulated status based on spurious “equivalent” modifications
Bayer wants to have the present petition considered an extension of its
previous petition 98-329-01p for non-regulated status for events
LLRICE62 and LLRICE06, which was granted in 1998. Bayer claims that the
three rice transformation events yield “equivalent” modifications.
This extension, if granted, would make a mockery of the present
event-specific regulation, which recognizes that the transgenic variety
resulting from genetic modification technology is specific to the
transformation event, and no two events - even in the same experiment
using identical constructs, vectors and plant tissues - can be
considered “equivalent”.
All three varieties LLRICE601 and LLRICE06 and LLRICE62 have the single
bar gene (for glufosinate tolerance) driven by a CaMV promoter. But
there the similarity ends. Although they all express the PAT protein
that inactivates gufosinate, the protein probably differs in size and
level of expression in different lines. The protein in LLRICE601 has an
aspartic acid at position 2 where both those in LLRICE06 and LLRICE62
have a serine residue. USDA/APHIS claimed that the difference was
insignificant because many other crops with similar variants have been
designated unregulated. But past mistakes in regulation does not make
the present one right. Moreover, the N-terminal amino acids are normally
involved in important cellular transactions that are very likely to be
affected by the amino acid substitution.
LLRICE06 and LLRICE62 were produced by a process described as
“direct”gene transfer, while LLRICE601 was produced by Agrobacterium
transformation. The CaMV promoter is longer in LLRICE601 than in
LLRICE06 and LLRICE62. LLRICE601 uses the nos terminator while LLRICE06
and LLRICE62 use the 35S CaMV terminator. LLRICE601 also has a second
CaMV promoter inserted somewhere in the genome during the transformation
of the rice cells.
Above all, each transgenic rice variety has chromosomal inserts at
different locations in the genome, and involved genetic modification of
different rice varieties: LLRICE06 was created from medium grain variety
M202, LLRICE62 from the medium grain variety Bengal, and LLRICE601 from
the long grain variety Cocodrie.
Thus, there are many important differences between LLRICE601 and
LLRICE06 or LLRICE62, and they can in no way be considered “equivalent”
[1, 3-6].
USDA tested similar transgenic rice nearby
LLRICE601 has been implicated in widespread pollution of rice grown in
the United States. However, during the period that Bayer’s varieties
LLRICE06 and LLRICE62 (both unregulated), and LLRICE601 (now seeking
approval) were tested in open fields in Louisiana and Arkansas, other
field trials were taking place. These were Liberty rice events developed
jointly by the USDA, University of Arkansas and University of Louisiana,
with DNA inserts similar to LLRICE601, LLRICE06 and LLRICE62, but have
not yet been submitted for unregulated status.
As field tests of the USDA-Universities Liberty rice events overlapped
in time and location with the origins of the transgenic contamination of
rice stocks (see below), one should expect USDA/APHIS to recuse
(disqualify) themselves from the investigation of the genetic
contamination of food crops by LLRICE601 on the basis of possible
involvement or conflict of interest, and to allow a body of competent,
independent investigators to conduct the investigations at “arms length”.
USDA transgenic rice studied for contamination of wild rice
The USDA-University transgenic rice events field-tested alongside
Bayer’s three LLRICE events were produced in Louisiana. Using biolistic
methods, a number of rice lines were transformed with a plasmid
delivering the bar gene (driven by the CaMV 35S promoter and maize
alchohol dehydrogenase intron, and terminated by the nos terminator),
accompanied by a hygromycin resistance gene and a GUS (enzymatic color
marker), both also driven by the CaMV 35S promoter. Transformants
containing low copy number of inserts failed to express the gus gene due
to gene silencing [7]. Hybridization between the transformed transgenic
rice lines (Cypress and Bengal) and the weed red rice was carried out to
examine the spread of transgenes to weedy relatives and the dispersal
and dormancy of weed hybrid seed. Seed dormancy and dispersal were about
the same in transgenic and non-transgenic lines [8], while out-crossing
frequency of glufosinate resistance to weedy red rice was about 0.3
percent [9]. USDA was involved in studying the spread of transgenes from
rice; and hence must have been aware that extensive field-testing in the
rice growing areas of Louisiana and Arkansas could only result in
extensive transgene contamination of the commercial crop.
Even though field tests of transgenic rice have been done in Puerto
Rico, Texas, California, Mississippi, Louisiana and Arkansas, the main
impact of transgenic contamination ascribed to LLRICE601 appears to be
centered around Arkansas and Louisiana. The USDA center of rice research
and rice germplasm storage is located at the Dale Bumpbers National
Research Laboratory in Stuttgart, Arkansas County. The University of
Arkansas, too, has a rice research laboratory in Stuttgart. Both
laboratories were involved in the development and testing of Liberty
transgenic rice. Bayer’s LLRICE601 field test sites were located in Drew
Crittenden County and Jackson County [1], all within less than an hour’s
drive from the USDA laboratory in Arkansas County; and the USDA rice
tests were located in Hempstead County [8, 9], within easy reach of the
USDA laboratory.
LLRICE601 not adequately characterized or risk assessed
LLRICE601 was transformed using the Agrobacterium vector system that
integrates T-DNA from a disarmed Ti (tumour-inducing) plasmid. There is
evidence of multiple complex patterns of T-DNA integration into the rice
genome. About a third of transformation events are accompanied by DNA
integrations extending beyond the T-DNA boundaries [10]. Furthermore,
T-DNA insertions cause mutations by disrupting target genes in the
chromosomal integration site [11]. There appears to be no attempts at
identifying the mutated gene(s) in LLRICE601.
Will transgenic pollen introgression into red rice ultimately lead to
the formation of a “super” weed? Will multiple-resistance appear in US
rice creating super weed volunteers as more than one herbicide-tolerance
traits have been used in rice? It seems likely that the multiple
herbicide resistance encountered in canola [12] (What Lurks Behind
Triple Herbicide-Tolerant Oilseed Rape?) will appear in rice if
herbicide tolerant rice is grown on a large scale.
USDA wants organic farmers to turn a blind eye to transgenic contamination
USDA is the final authority on organic certification in the US. But it
is taking steps to undermine this standard, as is clear from the
USDA/APHIS draft environment assessment of LLRICE601 on behalf of Bayer
[4]: “The presence of a detectable residue of a product of excluded
methods alone does not necessarily constitute a violation of the
National Organic Standards.” In practice, planting genetically-modified
seed would render the organic crop non-organic and require it to be sold
as conventional. But the USDA/APHIS goes on to state: “The status of the
organic operation depends on the operator’s foreknowledge of the origin
and status of the seed planted.” In other words, what the operator does
not know, does not count. So organic farmers are encouraged to maintain
their ignorance. Unfortunately, their customers do not hold the same view.
USDA has not stipulated a requirement that rice fields contaminated with
genetically modified rice should be identified, knowing full well that
pollen flow will pollute neighboring organic fields, as well as
non-organic fields. The polluted “organic” crop may be deemed organic in
US but it is unlikely to be so considered in export markets. Approval of
transgenic rice should be accompanied by a clear recognition of
liability in case of contamination.
No case for deregulating illegal GM rice
Bayer has failed to provide a case for retroactive designation of
unregulated status for the LLRICE601, and a clarification is needed on
the role of USDA /APHIS as regulator of transgenic contamination when it
has all the appearance of being a potential perpetrator.
References
1. LLRICE601 USDA Extension Petition 06-234-01p 98-329-01p Bayer
CropScience Rice Glufosinate tolerant LLRICE601 2006
http://www.aphis.usda.gov/brs/not_reg.html
2. “Lousiana farmers file federal suits”, Richard Burgess, Acadiana, 22
September 2006, http://www.2theadvocate.com/news/acadiana/4206241.html
3. “Gene-altered profit-killer. A slight taint of biotech rice puts
farmers’ overseas sales in peril”, Rick Weiss, Washington Post, 21
September 2006.
4. USDA/APHIS Draft Environmental Assessment In response to Bayer
CropScience Petition 06-234-01P seeking Extension of Determination of
Non-regulated Status for Glufosinate Resistant rice, Oryza sativa, event
LLRICE601 06-234-01p_pea 06-234-01p_fr_pc_pet 2006
http://www.aphis.usda.gov/brs/not_reg.html
5. Petition for determination of nonregulated status for LibertyLink
Rice transformation events LLRICE06 and LLRICE62 98-329-01p AgrEvo Rice
Phosphinothricin tolerant LLRICE06,LLRICE62 1998
http://www.aphis.usda.gov/brs/not_reg.html
6. USDA/APHIS Environmental Assessment AgEvro USA Company Petition
98-329-01p 1998 http://www.aphis.usda.gov/brs/not_reg.html
7. Oard JH, Linscombe SD, Braverman MP, Jodari F, Blouin DC, Leech M,
Kohli A, Vain P, Cooley JC and Christou P. Development, field
evaluation, and agronomic performance of transgenic herbicide resistant
rice. Molecular Breeding 1996, 2, 359-68.
8. Oard J, Cohn MA, Linscombe S, Gealy D and Gravois1 K. .. Field
evaluation of seed production, shattering, and dormancy in hybrid
populations of transgenic rice (Oryza sativa) and the weed, red rice
(Oryza sativa). Plant Sci. 2000, 157(1), 13-22.
9. Zhang N, Linscombe S and Oard J. Out-crossing frequency and gentic
analysis of hybrids between transgenic glufosinate resistant rice and
the weed red rice. Euphytica 2003,130,35-45
10. Vin Z and Wang G. Evidence of multiple complex patterns of T-DNA
integration into the rice genome. Theoretical and Applied Genetics 2000,
100, 461-70.
11. Jeon JS, Lee S, Jung KH, Jun SH, Jeong DH, Lee J, Kim C, Jang S,
Yang K, Nam J, An K, Han MJ, Sung RJ, Choi HS, Yu JH, Choi JH, Cho SY,
Cha SS, Kim SI and An G. T-DNA insertional mutagenesis for functional
genomics in rice. Plant J. 2000, 22(6), 561-70.
12. Ho MW. What lurks behind triple herbicide-tolerant oilseed rape?
ISIS Report 2002. http://www.i-sis.org.uk/whatlurk.php
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