NOTE: It seems from this that Monsanto actually wrote a report for a regulatory committee (!) - "TAC Sub-Committee Recommendations and Findings", and that the report contained important information that appears to be false.

EXTRACTS: [The] claim made in [the] Monsanto-written report ["TAC Sub-Committee Recommendations and Findings"] about conducting all sorts of [GM field] trials was simply contrary to facts.

It is [a] harsh reality that Monsanto, a seed marketing company, prepared a report about its own seeds cultivation and imposed it on regulators.

On the other hand, [the] head of TAC [Technical Advisory Committee - a regulatory committee] first decided to hold a meeting to discuss this report but later emailed it to members of [the] committee [] seeking their comments in a week.

This hurriedness [raised] eyebrows and stirred a controversy, prompting several members to express their reservation about the process. [This is] why [the] head of Technical Advisory Committee tendered his resignation last week following disclosure of [the] whole episode about [the] Monsanto-written report.
---
---
Foreign company speaks on GM corn field trials
The News, June 16 2011
http://www.thenews.com.pk/TodaysPrintDetail.aspx?ID=6758&Cat=13&dt=6/16/2011

LAHORE: Monsanto Pakistan had submitted an application in October 2008 seeking approval for seed import and field trials of Genetically Modified corn in Pakistan. The permission was granted and the process of field trials continued for two years. The trials concluded successfully in December 2010, and consequently, in February 2011, Monsanto Pakistan submitted an application and a scientific dossier seeking approval for commercial release of Genetically Modified Corn. This product is named VT Double Pro.

It provides in-plant protection with dual modes of action to protect against certain above-ground pests that plague Pakistani farmers, including the corn Stem borer, (Chilo partellus), American bollworm (Helicoverpa armigera), army worm (Spodoptera litura) and beet armyworm (Spodoptera exigua). This product also provides the corn plant with tolerance to glyphosate, the active ingredient in Roundup(r) brand agricultural herbicides, opening up new possibilities for weed control for Pakistani farmers.

Till date, VT Double Pro has been planted on millions of acres in 9 countries. The safety of VT Double Pro as stack or singles for food & feed or environmental releases purposes has been approved by regulators in over 20 countries, including regulators in the United States, Argentina, Australia/New Zealand, Brazil, Canada, China, Colombia, Honduras, Indonesia, Japan, Korea, Malaysia, Mexico, Philippines, Russian Federation, Singapore, South Africa, Taiwan and the European Union.

The National Bio-safety Committee (NBC) authorized Monsanto to import limited quantities of VT Double Pro seed to conduct field trials under permit. These trials were conducted strictly in accordance with protocols established by the Field Monitoring Sub-committee of the Technical Advisory Committee (TAC). As per its trial permit, Monsanto submitted the locations of the trials, type of trial (Agronomic / Phenotypic evaluation, NTO studies, Ecological interactions, Productions of crop tissues for gene expression studies, Insect bio-efficacy, Weed control with Roundup(r) herbicide, Crop safety against use of Roundup(r) Herbicide, Large Scale etc.), planting dates, plans for field operations to National Bio-safety Centre for the each year. Members of the Field Monitoring Sub-committee of TAC visited all the trial locations a number of times to witness the product performance, verify adherence with trial permit conditions and collect necessary relevant data. A year wise monitoring report of the field trials is issued by Field Monitoring subcommittee of TAC as well.

As part of the regulatory process, the Technical Advisory Committee (TAC) must review the field trial study results and scientific dossier prior to consideration by the NBC. The TAC formed a subcommittee to carry out an initial review. As the applicant, we were required by the sub-committee to provide a summary of our submission and recommendations as a starting point for review by the subcommittee. We were asked to provide this in a format that would be edited to reflect the subcommittee’s views following its deliberations. It is this document which was originated within Monsanto and submitted to, and at the request of the subcommittee for their consideration, amendment, and use.

The sub-committee is responsible for making recommendations to the TAC. The TAC in turn is responsible for deciding upon a final recommendation to be sent to the NBC. The TAC provides their written views to the NBC, which makes the final regulatory decision. Our involvement in this matter is no more complicated than this.

Benefits of Biotech Crops

There are substantial data available that shows the benefits of biotechnology to farmers and the environment. According to the 2010 ISAAA (International Service for the Acquisition of Agri-biotech Applications ) report, from 1996 to 2009, biotech crops contributed to Sustainability and Climate Change by: increasing crop production and value by US$65 billion; providing a better environment, by saving 393 million kg active ingredient (AI) of pesticides; in 2009 alone reducing CO2 emissions by 18 billion kg, equivalent to taking 8 million cars off the road; conserving biodiversity by saving 75 million hectares of land; and helped alleviate poverty by helping 14.4 million small farmers who are some of the poorest people in the world. As 15 million farmers in 29 countries around the world plant and harvest their biotech crops this season, we need to consider the fact that our farmers are already over a decade behind.

Munawar Hasan adds: It is astonishing to note that Monsanto, agri-biotech giant, has admitted that "TAC Sub-Committee Recommendations and Findings" report containing outcome of trails was prepared by its staff, which also comprised clear recommendation that GM corn seed be allowed for commercial release. In other words, the applicant has assumed the role of regulator and submitted findings as per its wish list, bulldozing laid down procedure.

It is pity that instead of assuming prime responsibility of physical assessment of trials, members of sub committee of Technical Advisory Committee (TAC) have no time to even write a sentence for recommendation of GM seed of corn/maize.

On the other hand the paragraph containing recommendatory note only exists in executive summery of report. There is no indication of following recommendation in actual report, which was admittedly written by Monsanto: “Based on the information presented by Monsanto in the submission, it is concluded that MON 89034 ¹ NK603 maize is unlikely to present any biosafety risks compared to conventional maize. Therefore, Technical Advisory Committee recommend the approval of MON 89034 ¹ NK603 to the National Biosafety Committee for commercial release.” Monsanto claimed that “we were asked to provide this in a format that would be edited to reflect the subcommittee’s views following its deliberations is a direct allegation on members Sub Committee. Monsanto should have revealed name of person who asked for ready-made report.

Moreover, Monsanto claimed that large scale field trials of GM corn are conducted. However, it is a matter of fact that these trials could only be conducted after successful completion of regulatory trial. As per procedure, regulatory trials required two-year for completion, two autumn and two spring seasons, and based on its outcome, National Biosafety Committee (NBC) gives permission for large-scale trials.

As per Monsanto version, company submitted an application in October 2008 seeking approval for seed import and field trials of Genetically Modified corn in Pakistan. Assuming that Monsanto imported seed instantly and started regulatory trial in October 2008, it can not complete trials before October 2010. It is obvious that last eight months are not enough for seeking approval for large scale trials and conducting it physically.

Hence, claim made in Monsanto-written report about conducting all sorts of trials was simply contrary to facts.

It is harsh reality that Monsanto, a seed marketing company, prepared a report about its own seeds cultivation and imposed it on regulators. On the other hand, head of TAC first decided to hold a meeting to discuss this report but later emailed it to members of committee for seeking their comments in a week. This hurriedness created eyebrows and stirred a controversy, prompting several members to express their reservation about the process. Last issue, if everything is as usual and as per procedure, why head of Technical Advisory Committee tendered his resignation last week following disclosure of whole episode about Monsanto-written report.