10^th^ September 2006

PROTEST AGAINST THE STATED INTENT OF APHIS (USDA) TO DEREGULATE
LLRICE601

http://www.regulations.gov/fdmspublic/component/main

We note that APHIS has made a preliminary decision to extend
determination of nonregulated status to LLRICE601.  We hereby protest in
the strongest possible terms against your intent to deregulate this
failed GM variety.

**1.  GENERAL OBSERVATIONS**

1.1  We also protest strongly that APHIS / USDA has set itself upon a
course of representing a very serious GM contamination incident as \"a
simple administrative oversight\" \-- and in so doing brings the whole
regulatory process in the USA into disrepute.  It has become involved in
cover-up of the scale and seriousness of the contamination offence, and
has allowed itself to be sucked into a damage limitation exercise on
behalf of the US administration.  In other words, it has placed
political and economic considerations above health and safety
considerations.  It has treated the interests of the marketplace, and
investors, above the interests of the consumer and the environment.  It
has thus strayed into territory that should properly be occupied by
others.

1.2  We also protest strongly on the grounds that the preliminary
decision to deregulate LLRICE601 is based upon bad science, with many
assurances from the offending company (Bayer CropScience) accepted by
the regulators but based upon \"invisible evidence,\"  and with key
information hidden from scientific scrutiny by CBI classification. 
About 30 pages and other key diagrams have been deleted from the public
access document APHIS-2006-0140-0003 without any justification. 
 Assumptions and assurances seem to have been accepted by the regulators
across the board, without regulatory examination of the hard data. 
Indeed, since this offence relates to a line discontinued in 2001, we
suspect that in many instances the company has simply made
extrapolations from other LL rice lines.  Where is the evidence that
LLRICE601 has maintained its molecular characteristics over the five
years 2001 - 2006 without \"gene scrambling\"?  Where is the evidence
that something that might have been safe in 2001 is still safe today?

1.3  It almost beggars belief that a biotechnology corporation can
commit a very serious offence by allowing a discontinued and redundant
GM variety, which is acknowledged to be unfit for human consumption,  to
enter the food chain without being instantly penalized; that it can then
communicate behind the scenes with the regulatory body which has
responsibility for enforcing the law to achieve a measure of \"damage
limitation\";  that it can ask the regulator for the status of the
offending material (LL601 rice) to be changed following the commission
of the offence;  that it can ask the regulator to hide from the public
all of the key information concerning the stability, uniformity, health
and safety of the offending variety;  and that the \"impartial\"
regulator, which is supposed to protect the public and the environment,
can accede to all of the offender\'s requests and in fact work with it
to belittle the scale and seriousness of the offence and effectively to
defend and promote the interests of the offender.  This all reveals
APHIS as a regulatory body which is failing to regulate; and as a body
involved in a conspiracy to protect an offender and deceive the public.

**2.  SPECIFIC POINTS**

2.1   On P 6 of the APHIS draft Environmental Assessment (1), there is
mention of Purpose and Need.  It is extraordinary that neither USDA,
FDA, APHIS or Bayer have made even the feeblest attempt to argue that
there is any PURPOSE or NEED for deregulation.  This is highly
significant. 

There is no PURPOSE behind this application other than the evasion of
liability by Bayer CropScience for the unauthorised release into the
environment and the food chain of a product currently deemed unfit for
human consumption. It is no part of APHIS\'s function to connive with
this cynical and opportunistic petition for deregulation for a product
which will never be commercialized and which is by any definition a
\"failed variety.\"  It is clearly not Bayer\'s PURPOSE to use, market
or develop this line any further;  and to deregulate it under the
present circumstances would bring the whole regulatory process into
disrepute.  

There is clearly no NEED for the variety either.  The rice farming
industry is not exactly clamouring for it, and there is no market niche
which needs to be filled.  It is not needed in foreign markets either
for growing or for feed and food.  Bayer has already effectively decided
that its LL rice varieties (including LL06, LL62 and Ll601) have no
place in the market-place.  In spite of the deregulation that occurred
in 1999, the only LL rice crop grown and intended for commercial release
was that grown on Garrett Farms, Texas, in 2000, which was stored for
one winter and then dumped into a landfill pit.  If there was no market
then, there is even less of a market now, and Bayer cannot possibly
argue that LL601 NEEDS to be deregulated.  We therefore protest strongly
on these grounds.

If there is no purpose or need for LLRICE601 to be deregulated, it
should continue to be a regulated article.  We ask for the petition to
be denied on these grounds.

2.2   According to p 5 of the Draft Environmental Assessment, LLRICE601
has never been intended for commercialization and has never been
submitted to FDA for evaluation as human food.  FDA says that Bayer has
provided \"information about the safety of the PAT protein, molecular
characterization, and nutritional composition of grain from LLRICE601. 
Based on the available data and information, FDA has concluded that the
presence of this bioengineered rice variety in the food and feed supply
poses no food or feed safety concerns.\"  This statement cannot possibly
we well founded, since it is based upon unsupported assumptions of
substantial equivalence and on mysterious evidence that is not available
for anybody to examine.  The \"information\" provided by Bayer could
have been fanciful or fraudulent, and the complacency / connivance of
FDA should be a source of shame to the regulators.  In these
circumstances, there are NO grounds for assuming that LLRICE 601 is safe
either as animal feed or human food.  It cannot even be assumed that
LL62 is safe to eat.  Indeed, it is clear from the fact that Bayer has
effectively withdrawn all of its LL rice varieties that there may be
serious problems relating to their stability and uniformity, and it
would be wiser, in these circumstances, to assume that LLRICE601 is
UNFIT FOR HUMAN CONSUMPTION until the company provides unequivocal
evidence to the contrary.

2.3   Field testing of LLRICE601 continued into the year 2001.  Its
development was then discontinued.  For five years the company showed no
interest in the variety.  Suddenly a Field Evaluation Report on the
performance of LL601 (various lines) was submitted to APHIS on 4th
August 2006.  The research on which the Report was based was completed
in 2001.  There would have been absolutely no reason for the submission
of this report last month except in preparation for an extremely belated
petition for deregulation.  Bayer officially notified USDA of the LL601
contamination incident on 31st July 2006.  It is obvious that an
immediate agreement was made between USDA and Bayer that deregulation
would be requested and agreed to.  No announcement was made to farmers,
importers or the general public about the incident until 18th August
2006.  No adequate explanation has been given for this delay.  During
the 18-day interval it is obvious that both Bayer and APHIS were hard at
work on the preparation of the \"case for deregulation.\"  In fact, the
APHIS draft Environmental Statement reads more like a piece of advocacy
than an impartial assessment of the facts laid before it.  In our book
this indicates a totally unacceptable level of cooperation and
connivance between a regulator and a company guilty (by its own
admission) of allowing a regulated and unfit article to enter the food
chain. There is no doubt that it had committed a serious offence.   In
such circumstances USDA should have behaved with great circumspection;
instead it participated in a deliberate attempt to cover up the
incident, to protect the offender, to promote the offender\'s interests,
and to mislead the public into a belief that all was well.  To proceed
to the deregulation of LLRICE601 now would be tantamount to conspiracy,
and would  compound an already corrupt situation.

2.4  There is other evidence of an improper and even corrupt
relationship between the regulator (USDA) and the offender (Bayer).  We
note that the key author of the USDA / APHIS response to the Bayer
petition (dated 17 August 2006) is Cindy Smith, Deputy Administrator,
Biotechnology Regulatory Services.  She was present alongside
Agriculture Secretary Mike Johanns at the \"press conference\" on 18th
August, and answered a number of questions from journalists.  On the
record, she told two lies (2), one relating to the regulatory status of
LLRICE601 and the other relating to past episodes of GM rice
contamination.  It is clear from the tenor of the press conference, and
from Ms Smith\'s remarks, that a strategy had already been agreed by 18
August for USDA and FDA to minimise the offence committed by Bayer
CropScience and to represent that offence simply as an administrative
oversight.  The fact that Cindy Smith said that LL601 \"was approved
previously to be marketed\" indicates either an inadequate knowledge of
the regulatory status of LLRICE601 or an intent to deceive.  In any
event it is apparent that the APHIS response (APHIS-2006-0140-002) is
tainted by the fact that the lead author has made a personal commitment
to protect the interests of a biotechnology corporation which has
committed a very serious offence.  On this basis alone, the APHIS
document should be withdrawn, and rewritten by an officer who is
genuinely impartal.  

**3.  NOTICE OF FURTHER SUBMISSIONS**

3.1  We give notice that we intend to submit further protests of a more
detailed nature during the consultation period which ends on October
10th.

**4. NOTES**

(1)  APHIS-2006-0140-0002

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

\(2\)    Ms Smith said in relation to LLRICE601:  \"this was a crop that
actually while it was approved previously to be marketed the company had
not yet brought it to market.\"  Wrong.  LL601 has never been approved
for release into the environment or for marketing.  It was
\"discontinued\" by Bayer and a request was never submitted for
deregulation before the company cynically asked for \"retrospective
deregulation\" on 22 August. She must have known that.  She was also
asked:  \"\....  you\'ve had other instances in the past where crops
have been contaminated between biotech and traditional crops. Is this
the first time this has happened as far as rice is concerned?\"  In
reply, she said:  \"That\'s correct\...\.....We\'ve not had any other
situations involving rice.\"  Wrong.  We have indeed had other
situations involving rice.  It has been on the record since early in
2005 that illegal Bt rice has been contaminating rice crops in China.
And Ms Smith must have known of the Heinz babyfood scandal in China in
the spring of 2006, when Bt63 was found in rice.  It is inconceivable
that Ms Smith, as a specialist in this area, could have been unaware of
these incidents.

We asked Cindy Smith on 29th August to correct these pieces of
misinformation, but she has not responded.

Ref:

http://www.usda.gov/wps/portal/!ut/p/\_s.7_0_A/7_0_1OB/.cmd/ad/.ar/sa.retrievecontent/.c/6_2_1UH/.ce/7_2_5JM/.p/5_2_4TQ/.d/3/\_th/J_2_9D/\_s.7_0_A/7_0_1OB?PC_7_2_5JM_contentid=2006%2F08%2F0308.xml&PC_7_2_5JM_parentnav=TRANSCRIPTS_SPEECHES&PC_7_2_5JM_navid=TRANSCRIPT#7_2_5JM

Answering questions: Secretary of Agriculture Mike Johanns

Deputy Administrator for Biotechnology Regulatory Services, Cindy Smith

Dr. Robert Brackett from the U.S. Food and Drug Administration

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

Please acknowledge the safe receipt of this objection to deregulation.

Yours sincerely,

Dr Brian John

GM Free Cymru

Trefelin, Cilgwyn

Newport

Wales SA42 0QN