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The following is mirrored from its source at: http://www.genewatch.org/News/MonsRpt.htm
See GeneWatch UK's press release on Monsanto's leaked document.


THE FOLLOWING INTERNAL MONSANTO REPORT
WAS LEAKED TO GENEWATCH UK

 

COMPANY CONFIDENTIAL

Regulatory Affairs and Scientific Outreach
Monthly Summary
May and June, 2000

Highlights:
Global: Scientific outreach and Ag Regulatory was instrumental in assuring that key internationally recognized scientific experts were nominated to the FAO/WHO expert consultation on food safety which was held in Geneva this past month. The consultation and final report were very supportive of plant biotechnology and the safety assessment of these products.
Global:
A scientific manuscript reviewing virtually all Monsanto and publicly-available studies on glyphosate, AMPA, Roundup herbicide and the polyethoxylated tallowamine surfactant (POEA) was published by leading mammalian toxicology experts. The paper concludes that, under present and expected conditions of use, Roundup herbicide does not pose a health risk to humans.
U.S.:
The Bt soybean EUP was approved by the EPA, allowing planting of field trials on 66 acres for the 2000 growing season.
U.S.:
Corn event NK603 continues to progress on or ahead of schedule at the USDA. The agency published a Federal Register notice proposing to deregulate Roundup Ready corn event NK603 and announcing the availability of the environmental assessment document. The 30-day public comment period will end on July 21, 2000
U.S.:
The final USDA decision to deregulate NewLeaf Plus event 082 potatoes was published in the Federal Register on June 15 and goes into effect on July 17. Changes in process and data requirements at the agency delayed completion of the deregulation process from the anticipated 9 months to over 12 months.
U.S.:
Applications for registration of Corn Rootworm-protected corn event MON 863 and the amendment of the B.t. protein tolerance exemption petition were submitted to EPA. An extensive IRM plan for CRW-Protected Corn was included as part of this submission.
U.S.:
The submission to FDA for Bollgard II cotton event 15985 was completed. The approval is needed for the harvested materials from the 2001 season and entry into commerce for food and feed. The approval is expected 1Q01.
U.S.:
We have submitted a request to EPA to amend the IRM requirements for Bollgard cotton; the proposed refuge options are expected to meet with approval from both EPA and growers, and we anticipate that EPA will grant an extension of the Bollgard registration through 2001.
Brazil:
The reporter judge of the appeals court issued a negative recommendation to the other two judges on the panel. The other two judges declined to vote and the court recessed for vacation until August. Therefore, we do not have a definitive opinion by the court but we also do not have freedom to proceed with the related regulatory approvals required for commercialization of RRSoy in Brazil.
Columbia:
The National Biosafety Committee of Colombia, South America, approved field trials for Bollgard cotton. The approval completes an application process that has continued for more than nine months, and represents a significant step forward to gaining acceptance of genetically modified crops in Colombia.
Korea:
The Korean Food and Drug Authority approved the safety of Roundup Ready Soybeans for import and use as food and feed. This endorsement of the safety, including the previously undetected gene sequences, is the first such explicit, official approval in Asia and represents an important milestone in the region.
India:
The Review Committee for Genetic Manipulation (RCGM) issued biosafety clearance for Bt cotton, thereby completing the scientific review of the food, feed and environmental safety of this product. The RCGM recommendation was forwarded to the Genetic Engineering Approval Committee (GEAC) which granted approval for larger scale field trials. The GEAC will discuss seed bulk up and marketing approvals at its next meeting.
Russia:
The Russian Ministry of Health issued food/import registration of New Leaf Russet Burbank and New Leaf Superior potatoes.
Russia:
The Russian Ministry of Health approved favorable GMO food labeling guidelines which include a 5% threshold (based on dry weight) and an extensive negative list.
Bulgaria:
The Parliamentary Environmental Commission voted down the moratorium currently in effect for biotechnology products, recognizing the potential benefits of the potato technology transfer project and other biotechnology crops.

Roundup Ready Corn:
U.S.:
On June 21, USDA published a Federal Register notice proposing to deregulate Roundup Ready corn event NK603 and announcing the availability of their environmental assessment document. The 30-day public comment period will end on July 21, 2000. Growers who support this technology are being encouraged to provide comments to USDA.
E.U.:
We are proceeding with an additional transcription study on GA21 requested by Austria for the Import 90/220 dossier and addressing a labeling issue that was the subject of questions and/or objections from Deninark, Spain, Sweden, France, the Netherlands and Norway. We have completed negotiations with Spain to ensure confidentiality of the data required by the SCP for the Production 901220 dossier. We have received seven objections to date (from Austria, Belgium, Denmark, Greece, Ireland, Italy and Sweden) on the Novel Food dossier. The file was formally referred to the SCF by DG SANCO.

Bt Corn:
China:
Our submissions for approval of Bt Corn and Cotton were denied. The stated reason was lack of local environmental fate data but underlying politics are also important. China is trying to be a source of GMO free material for Europe while at the same time aggressively developing biotechnology itself We are developing a plan to provide environmental fate data and are working with GA to address the political aspects of the situation.
Philippines:
The technical report of the Yieldgard field trial was completed. Records show 30-68% yield increase in Yieldgard (7.1-8.5 t/ha) over conventional corn (4.4-5.1 t/ha) while its susceptible check variety Supersweet yielded only 1.44 t/ha. Leaf feeding, stalk and ear damage ratings were visibly high in conventional corn. Beneficial arthropods, particularly green lacewing, spiders and coccinellids, were abundant in both Yieldgard and conventional corn.

Corn Rootworm Protected Corn:
U.S.:
The submission and request for approval of MON 863 as our priority corn root worm control protein has been made to EPA. The approval of this event appears to be the best commercial decision and will allow the agency to concentrate on our highest priority for corn root worm control. An extensive IRM plan for CRW-Protected Corn was included as part of this submission. Regulatory petitions for MON 853 that were previously submitted in Japan were withdrawn.

RR Soy
Brazil:
The reporter judge of the appeals court issued a negative recommendation to the other two judges on the panel. The other two judges declined to vote and the court recessed for vacation until August. The reporter judge's recommendation was that a definitive Environmental Impact Statement is required prior to any commercialization. Therefore, we do not have a definitive opinion by the court but we also do not have freedom to proceed with the related regulatory approvals required for commercialization of RRSoy in Brazil. In addition, the original trial judge issued a new order in a related class action case declaring all CTNBIO actions unconstitutional and requiring a total rework of regulations for biotechnology products.
Brazil:
IDEC (Consumers Union) in Brazil conducted genetic tests on a range of food products and sent letters to food producers indicating that their products were on the market illegally. General Mills received such a letter, and communications were made to clarify the status of imported manufactured food products in Brazil to the company.
Korea:
The Korean Food and Drug Authority approved the safety of Roundup Ready Soybeans for import and use as food and feed. This approval included the information Monsanto provided on the previously undetected gene sequences. This endorsement of the safety, including the previously undetected gene sequences is the first such explicit, official approval in Asia and represents an important milestone in the region.
Global:
Additional molecular characterization data for Roundup Ready soybeans was communicated to regulatory authorities around the world. USDA, FDA, Health Canada and CFIA have reviewed the data and issued letters stating that they have no safety concerns. Additional molecular information submitted to authorities in Japan and the U.K is still under review. Further details have been requested by the U.K Food Standards Agency and it is anticipated that responses to these requests will allow the U.K to complete its review and to forward the data, along with its positive opinion, to all 90/220 competent authorities. France and Austria have already requested and received the information from the U.K DETR.
Norway:
A number of food companies have requested information on the status of RR soya food approval. Safety information on RR soya was submitted in 1998, and the National Institute of Public Health found the product to be safe. However, its recommendation was never adopted politically, and Norway has not implemented the E.U. Novel Food regulations. The National Food Inspection Agency has received numerous applications for approval of GM soy products by local food companies but all have been withdrawn prior to an agency decision to avoid the impending media coverage.
Japan:
MAFF explained to food industries and importers that the threshold level for non-GMO soybean is 5 %. This is the first time MAFF made such an explanation in an open meeting.

Bt Soy:
U.S.:
The final revised EUP for the continental U. S. field trial program was approved by EPA and subsequently registered in the appropriate states in a timely fashion. An amendment to add limited acreage in Puerto Rico was subsequently submitted to EPA and local authorities to allow trials by Stine Seed.

Bt Cotton:
U.S.:
The submission to FDA for Bollgard II cotton event 15985 was completed. The approval is needed for the harvested materials from the 2001 season and entry into commerce for food and feed. The approval is expected in the first quarter of 2001. This submission also allows for the ANZFA submission in Australia, where the FDA submission is used as an appendix.
U.S.:
After further negotiations with EPA, Monsanto submitted a request to amend the refuge requirements of the Bollgard registration for the 2001 and beyond growing seasons. The amendment includes the following changes for insect resistance management: adds a 5% unsprayed cotton refuge that must be at least 150 ft wide and planted within 1/2 mi of Bollgard cotton, adds a 5% embedded refuge that must be planted as a contiguous block within the Bollgard field, maintains the original 80/20 sprayed external refuge option, removes the current 4% unsprayed option, allows for a community refuge program to be developed.
We expect a Federal Register notice to be published in the next few weeks, announcing the extension of the Bollgard and Bt corn registrations through September, 2001, as well as EPA's process and timelines for completing the full re-registration review process.
India:
The Review Committee for Genetic Manipulation (RCGM) issued biosafety clearance for Bt cotton, thereby completing the scientific review of the food, feed and environmental safety of this product. The RCGM recommendation was forwarded to the Genetic Engineering Approval Committee (GEAC) which granted approval for larger scale field trials. The GEAC will discuss seed bulk up and marketing approvals at its next meeting.
E.U.:
A response to a question on the safety of the Bt protein in feminine hygiene products was submitted to the E.U. Commissioner for the Scientific Committee on Plants in early March, 2000. The commission recently informed Monsanto that although our response was satisfactory, they will be forwarding the question to the scientific committees handling medical device and cosmetic issues.
Columbia:
The National Biosafety Committee of Colombia, South America, approved field trials for Bollgard cotton. This represents a significant step forward to gain acceptance of genetically modified crops in Colombia.

RR Wheat:
N. America:
The necessary APHIS and CFIA confined trial movement, release and import permits were obtained to allow bulk-up field production plans in the U. S. and Canada within the normal spring planting window. All necessary technology studies for the initial Roundup Ready wheat submissions to the USDA and FDA have been initiated and are on schedule.

Roundup Ready Oilseed Rape:
E.U.:
Some national authorities have examined the safety of RR oilseed rape, in the light of plantings of Advanta's non-GM varieties containing approximately 1% RR seeds in many E.U. countries. Safety has not been a major issue because RR oilseed rape is cleared for food use in the E.U., and the plants are sterile. However, media coverage in the U.K. has centered on liability issues, government reaction, negligence by Advanta and the lack of thresholds.
Ireland:
Detection methods were supplied to the Irish competent authority upon request to analyze seed and volunteer plants in locations where Advanta seeds were cultivated in previous years. These analyses will be conducted to address public and political questions.

Potato:
Russia:
The Russian Ministry of Health issued food/import approvals for NewLeaf Russet Burbank and NewLeaf Superior potatoes. This achievement represents a significant milestone in our efforts to expand biotechnology markets in the region. Approval for unconfined release is expected by the end of the year. U.S.: The final USDA decision to deregulate NewLeaf Plus event 082 potatoes was published in the Federal Register and goes into effect on July 17. This line was voluntarily withdrawn from the original 1998 approved petition and resubmitted in April 1999 after completion of additional molecular characterization.

Lawn and Garden:
U.S.:
The Roundup Pull 'N Spray packaging defect issue has been managed with minimal regulatory consequences. EPA commended both Scotts and Monsanto for the speed with which we responded to this issue and approved the Roundup label amendment and packaging changes so that reconditioned product can re-enter commerce.

Field Trails / Compliance:
Latin America:
A proposal was presented to the LA FTO team to develop a systematic training program for Argentine field trials and an oversight (auditing) program. The proposal was well received although the lack of resources in the region is a concern to be addressed.
U.S.:
A report on the status of field trials was developed by QA and Trait Development. The report delineates primary reasons for planting delays, summaries of projects, actions taken to respond to the needs of the research programs and proposed next steps to be taken to ensure delays are not experienced with the next planting season.
U.S.:
EPA performed an audit of two Monsanto sponsored studies conducted at MSE-Newstead and an inspection at Agro-Tech, a company where we have sponsored field residue trials. There were no negative findings in either case.

Regulatory Developments:
Global:
Extensive chemical and physical analyses of cotton linters processed from two varieties of the Bollgard X Roundup Ready combined trait product were analyzed by an external laboratory to address concerns about the use of GM cotton in certain products. The analyses showed that no protein or DNA was detected and that the fiber was equivalent to fiber from conventional cotton for all other parameters tested. A presentation on the safety, benefits and regulatory status of Monsanto cotton products was made to the Johnson & Johnson Personal Care Products Division.
Global:
Monsanto representatives were successful at the recent Codex Food Labeling Committee meeting in maintaining two labeling options for further consideration by the committee. This raises the legitimacy of voluntary food labeling of products obtained from biotechnology for efforts in third world countries considering labeling frameworks because the issue continues to be considered at Codex.
Global:
An agreement to establish the Agricultural Biotechnology Stewardship Technical Committee was signed by Aventis, Pioneer, Monsanto and Novartis. Still to sign is Dow-Mycogen. Eric Sachs was elected to chair the committee. This group will continue to focus on issues facing Bt corn and other genetically-modified crops.
U.S.:
Meetings continue with the Industry Task Force reviewing the FDA policy on the consultation process for biotechnology-derived products. The recent announcement by FDA included a mandatory 120 day premarket notification. Some task force members question the agency's legal authority to set such a policy while others feel we should support it.
U.S.:
The American Crop Protection Association Dietary Assessment Work Group held public meetings to review the databases used to support inclusion of use/usage data in dietary risk assessments under FQPA.  The meetings focused on the issues associated with the available databases and data collection methods. Future work will focus on the identification of data gaps and the prioritization of data needs to improve the FQPA risk assessment process.
France:
The French government announced that Golden Harvest corn varieties tested positive for Bt corn events Bt11, CG176 and an unidentified event. Opinions are divided within the government as to whether the planted fields of around 5,000 hectares should be destroyed. Monsanto provided materials and methods for MON810, and we are working with Golden Harvest and the Ministry of Agriculture to monitor developments. E.U.: The E.U. Standing Committee for Seeds discussed a commission proposal to regulate GM events in non-GM seeds. The proposal recommends rejection of varieties containing more than 0.5% of authorized GM events and more than 0% unauthorized events. No firm conclusions were reached. Industry groups support the current seed purity standards, with the possibility of following the OECD experimental scheme setting a limit on the presence of GM events at 1% (for those authorized in at least one OECD country). The Standing Committee will meet again on July 16, following the OECD meeting on July 5.
Germany:
At the EXPO2000 event held at German seed company KWS, Chancellor Schroeder publicly proposed to the ag biotech industry to "consider a voluntary agreement". His ultimate goal is to gain acceptance of ag biotechnology through the cautious introduction of GM plants in the coming three years. The three year program will focus on biosafety research and monitoring, and limited commercial field trials would be permitted. Unfortunately, Schroeder's comments were incorrectly reported as a call for a moratorium comparable to the U.K., and the German government is making efforts to clarify his statement. Italy: Italian authorities have proposed to unilaterally ban seven food products cleared under the Novel Food regulation notification process, including MON 810 and oilseed rape event RT73. They acknowledge that there are no health issues but question whether the ingredients should be considered as substantially equivalent.
Russia:
Authorities approved GMO labeling regulations which included a 5% threshold limit ( based on dry weight) and an extensive negative list (oils, lecithin, starch, fructose syrup, glucose, fructose, and common sugar).
Bulgaria:
The Parliamentary Environmental Commission voted down the moratorium currently in effect for biotechnology products, recognizing the potential benefits of the potato technology transfer project and other biotechnology crops.
Bulgaria:
Greenpeace efforts to launch a national campaign against biotechnology were successfully prevented. An Agro Business Forum was organized by the Bulgarian Ministry of Agriculture with the E.U. Commissioner and many other officials. Bulgarian scientists, journalists, farmers, and students worked together to promote the technology, and many positive papers appeared in the media.
Japan:
MHW has requested that we submit the newly required data (DNA sequence of 5' and 3' ends of the insertion and seed storage information) of already approved crops that we have available by June 30. They intend to start the review of the data quickly to avoid the possibility of importing unapproved crops on April 1, 2001 when the mandatory food safety assessment starts.
Japan:
Bourbon, a medium candy and cookies company, announced plans to switch to a non-GMO corn sweetener. The Japan Soft-drink Association sent a letter to member companies asking their careful consideration of such action because any switch has tremendous effects to all food and import industries. We are working with the Corn Starch and Corn Fructose Association to promote education on GMO food safety to member companies and their customers.
Thailand:
A GMO detection lab was established by the Ministry of Public Health to develop methods to certify exports to Europe. The lab director Dr. Pakdi is a key player in international CODEX activities and has requested Monsanto's assistance to train technicians and provide reference samples. Cooperation with this request is likely given the importance of the lab and Dr. Pakdi's position.
Mexico:
Silvia Llorens was appointed Coordinator of the Executive Committee of AgroBIO Mexico.

Scientific Outreach:
U.K.:
Scientific Outreach welcomes Dr. Andrew Cockburn, former Global Head of Toxicology and Head of U.K. Development for AgrEvo, to lead the European Scientific Outreach team. Andrew serves on several key committees and is a member of the Board of Trustees for ILSI HESI.
Global:
Significant outreach efforts were made to the medical and health fields of toxicology and nutrition through participation in key scientific conferences. Contacts were made with the directors of Poison Control Centers (PCC) in many countries which should be especially useful to facilitate rational regulation because the Poison Center directors are relied upon heavily by state and local agencies; a presentation was made to industry toxicologists and pharmacologists involved in the safety assessment of biotech food crops during the annual Symposium on Biotechnology sponsored by Sierra Biomedical; information on the benefits and safety of plant biotechnology was provided to key medical experts and students at Harvard at a Food Safety Symposium during a presentation and panel discussion; an editorial was drafted by Dr. John Thomas, (Emeritus Professor of U. Texas Medical School in San Antonio) to place in a medical journal as the first in a planned series of outreach efforts to physicians. a meeting was held with Prof. David Khayat, an internationally well known cancer specialist, to collaborate on an article demonstrating the absence of links between GM food and cancers; Monsanto chaired a session at the Society of Environmental Toxicology and Applied Chemistry (SETAC) meeting entitled: "GMOS: The Risk Assessment Challenge for the 21st Century."
Global:
Scientific papers were published or submitted on topics critical to the Monsanto Ag business. A publication on the compositional analysis of glyphosate-tolerant corn is now available and additional papers on CRE/lox, gene transfer and glyphosate safety have been submitted.
Global:
Meetings were held with renowned experts to foster scientific consensus building with key influencers and influence groups. Meetings were held with E. O. Wilson, a world renown expert on evolutionary biology from Harvard University as well as Gerard Pascal, a key influencer in the European scientific community and Domingo Chamorro a regional authority on agriculture in Spain. A presentation was also made to an influential group at the Genetic Resources Conference.
Global:
Research initiatives with third party institutions to support the safety and benefits of biotechnology crops continue to progress. Protocols were reviewed and approved to investigate nontarget impacts in CRW corn and Bollgard Cotton, biodiversity impacts from RR soybean system, genetic diversity in cotton in its center of diversity, and biodiversity impacts from Guardian Corn in Brazil. A protocol to study gene flow from RR canola in the U.K. is being negotiated.
Global:
Presentations were made at key academic institutions including, NC State University, Iowa State University, University of Wisconsin-Madison and a group of Nuffield Scholars from the U.K. Meetings were attended by scientists and students in the nutrition and food science disciplines. In addition, Scientific Outreach provided recommendations for scientific experts and topics for a New York Academy of Sciences session designed to brief key journalists and media on biotechnology issues.
Global:
The Scientific Outreach network and the Technology Issues Team averted attacks on recently emerging biotechnology issues. The team developed rapid responses to avoid over-reaction to claims regarding unapproved corn events were detected in animal feeds, gene transfer by honey bees and the characterization of additional non-functional DNA in Roundup Ready soybeans. Two op-eds on the honeybee issue by notable scientists were triggered to help avoid additional high profile press coverage.
Global:
Scientific outreach and Ag Regulatory was instrumental in assuring that key internationally recognized scientific experts were nominated to the FAO/WHO expert consultation on food safety which was held in Geneva this past month. The consultation and final report were very supportive of plant biotechnology, including support for the critical role of substantial equivalence in food safety assessments, antibiotic resistance markers used in these products, and the reservation of animal feeding studies to address specific questions rather than for routine safety assessment.
U.S.:
Critical outreach efforts continue to the food and feed industries. Presentations were made to the American Feed Industry Association, the Swine Nutrition Council of the American Feed Industry Association, several Animal Science Committees of the Federation of Animal Science Societies, the National Cattlemen's Beef Association Executive Committee and the IGD (International Grocery Distribution) on GMO issues in the U.K. and Europe. In addition, booths for Monsanto and the Council for Biotechnology Information were provided at the International Food Technologists. Over 350 "Invitation to Dialogue" kits were provided, many one-on-one discussions were held, and several follow-up requests were made for additional regulatory and food safety information.
Canada:
Another IRM monitoring survey will be conducted with OCPA for the 2000 season to determine whether IRM information is being received by Bt growers and to measure compliance. Results for 1999 indicate that >95% of Bt corn growers were aware of IRM requirements and the proper use of refuge.
France: Efforts continue to promote educational initiatives around biotechnology. A half day lecture was presented to a group of students in Paris in collaboration with Prof. Pailler, a toxicologist and expert on mycotoxins. In addition, a presentation was given at the IP Congress organized by agricultural students.
France: Scientific Outreach launched the "Forum des Biotechnologies", to give journalists the opportunity to discuss different scientific topics with scientists. The subject of the first edition was "The Genomics' stakes", with Prof Claudine Junien (INSERM; geneticist), Prof. Jean Daucet (geneticist, Medicine Nobel Prize) and Scientific Outreach outlined the Preston Project on the rice genome. About 40 journalists were present and the first outcomes were very positive. The next Forum will be held this fall.
Spain:
Outreach efforts continue to farmer organizations. Presentations were made at meetings organized by the farmer union attended by farmers, regional authorities for field trials, and Professors from Barcelona University.
U.S.:
Dave Gustafson gave a presentation on the potential sustainability benefits of ag biotechnology at the Gordon Conference on Industrial Ecology. The audience, including scientists from the U.S., Europe, and Asia, expressed great interest.

Chemical Products

Glyphosate:
Global:
A scientific manuscript reviewing virtually all Monsanto and publicly-available studies on glyphosate, AMPA, Roundup herbicide and the polyethoxylated tallowamine surfactant (POEA) was published by leading mammalian toxicology experts. The paper concludes that, under present and expected conditions of use, Roundup herbicide does not pose a health risk to humans.
U.S.:
The states of Wisconsin and North Dakota contacted Monsanto for support of their decisions to grant a Section 18 Crisis exemptions for Roundup Ultra for wiper application in horseradish and pre-harvest in flax, respectively. We agreed to support the use and provide a label in both cases.
Canada:
The temporary registration of Roundup Original for preharvest aerial application was extended with different buffer zones specified depending on sensitive aquatic or terrestrial adjacent areas. PMRA withdrew our submissions for full registration of Original, Transorb and FastForward due to insufficient aquatic non-target data. Plans are under development to challenge the agency's position because this is the first request for this data even though the original submission was made over six years ago.
Japan:
JCPA is preparing to launch a campaign to stop illegal sales and use of non-registered products. This program is important to stem the flow of unregistered glyphosate into important markets in Japan.

Sulfosulfuron:
Germany:
Regulator concerns about sulfosulfuron effects on nontarget plants were successfully addressed to obtain registration for Monitor.
Ukraine:
Monitor was registered for spring treatment on winter wheat.
U.S.:
Maverick Pro was approved by the EPA. This registration will help prevent product movement from the lower value plains area where only Maverick Pro is registered to the higher value Pacific Northwest where only Maverick is registered. The price differential between these 2 markets is approximately $2 per acre and the registration of Maverick Pro will help to preserve approximately $800k of sulfosulfuron income.

Halosulfuron-methyl:
U.S.:
Registration of Sempra CA (for California) was approved by EPA and provides an additional barrier to product movement between states. Sempra will only be registered in the lower value market of FL and Sempra CA will be registered only in the high value markets of CA and AZ. The price differential between these 2 markets is approximately $8 per acre and the registration of Sempra CA is estimated to save approximately $1M in income over the next 4 years.

MON 65500:
Belgium:
Authorities are considering labeling silthiopham as a category 3 carcinogen, an unwarranted classification given the molecule's toxicology profile. The product approval date is likely to be delayed as we challenge the agency's classification. We will make every effort to obtain approval in time for the 2000 season.

Triallate:
U.S.:
Significant progress was made to re-register triallate with the EPA. The agency determined that the water risk assessment is acceptable, indicating that it may move forward with re-registration without any requirements for mitigation that would impact our freedom to operate.

Acetochlor:
U.S.:
Monsanto will assume the role of managing agent of the Acetochlor Registration Partnership (ARP) on July 1, taking over from Zeneca which had been Managing Agent since 1995. Contingency plans are being developed should a sudden Zeneca sale of its interest in acetochlor cause Monsanto's day-to-day role on the ground water monitoring studies to suddenly increase. At the present time, all previously agreed regulatory timelines and budgets in both the U.S. and Europe are intact.

Multiple chemical:
Global:
Efforts continue with the Global Crop Protection Federation Nontarget Plant Work Group to finalize a new OECD guideline for terrestrial nontarget plant testing. The goal is to justify the use of the EC50 rather than an EC25 for risk assessment, and to develop an approach to address the concerns of regulators in various countries regarding effects of crop protection chemicals on aquatic nontarget plants.
Global:
EPA's Office of Pesticide Programs issued a Pesticide Registration (PR) Notice to all pesticide registrants and applicants announcing the existence of the FIFRA Endangered Species Task Force (FESTF) and the acceptance of the FESTF's proposal to the EPA regarding endangered species issues. The PR indicated that membership in the FESTF will satisfy endangered species requirements imposed by the EPA during the registration process. Monsanto has been a member of the FESTF since its inception, and the PR is likely to expand membership and decrease costs.
Italy:
MON 14420 was registered in Germany, representing our first registration of a "portfolio team" product.
Japan:
The MAFF is expected to announce the data requirements and test guidelines that will become effective in December, 2000. The newly added requirements include acute and repeated neurotoxicology studies, an aquatic environmental fate study, an aquatic ecotoxicology study and a micronucleus study. In addition, unofficially required studies will become official requirements: safety to neighboring crops, rotational crops, honeybees, silkworms, non-target insects, and avians.




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