RECOMMENDATIONS OF THE SUB-COMMITTEE ON BT COTTON AND RELATED ISSUES CONSTITUTED BY MINISTRY OF ENVIRONMENT & FORESTS UNDER THE CHAIRMANSHIP OF DR S NAGARAJAN, DIRECTOR IARI, NEW DELHI.

 

 

 

 

 

 

 

Interested Parties/Individuals are invited to give their comments on the recommendation by 31st  December 2005.

 

 

 

 

 

 

 

 

 

12th December  2005

Ministry of Environment and Forests

New Delhi

 

 

 

 

 

The views/recommendation are solely that of the Sub-Committee and not that of Ministry of environment and Forests or the Genetic Engineering Approval Committee.

 

 

 

Recommendations of the Sub-Committee on Bt cotton and related issues.

 

1.0       In accordance with the decision taken in the 56th meeting of the GEAC, MoEF had constituted a Sub-Committee under the chairmanship of Dr. S. Nagarajan Director IARI to look into the existing processes, protocols for large scale trials and other related issues to Bt Cotton and give recommendation for rationalization of the same.

 

2.0       The Composition of the Sub-Committee is as follows: -

 

i.          Dr. S. Nagarajan*, Director, Director IARI, Pusa. N. Delhi. -  Chairman

ii.         Dr B.M. Khadi, Director, Central Institute for Cotton Research, Nagpur.

iii.        Dr. T.V. Ramanaiah, Director, Department of Biotechnology.

iv.        Dr. T. P. Rajendran, ADG, ICAR, New Delhi.

v.         Dr. B.S. Dhillon, Director NBPGRI. (Scientist with Background of Bio-Statistics nominated by Chairman). 

vi.        Dr. S. Srinivasan Director CIRCOT, Mumbai.(co-opted Member)

vii        Dr. Ranjini Warrier, Member Secretary GEAC. - Member Secretary

 

* Presently, Chairman, Protection of Plant Varieties and Farmer’s Rights Authority

 

3.0       The Committee has made the following recommendations in respect of:

 

a.            Number of locations for LST.

 

1.         The number of LST trials from the present requirement of 80 per zone has been optimized as given  below.

 

    Table 1 Number of locations for LST of hybrid Bt cotton

 

Cotton hybrids*

Zones** /Locations***

Southern

Central

Northern

H x B

10

10

-

a x a

20

30

15

H x H

40

60

40

h x a

10

30

-

 

 

*H – hirsutum; B – barbadance; h – herbaceum; a – arborium

 

**            To be optimally divided between irrigated, rain-fed and suppressive soils (the trial may also accommodate both normal sown and late sown conditions)

 

***            The number of locations has been reduced taking into consideration the area under cotton cultivation in each zone and type of hybrids grown in the region.

 

This rationalization and significantly reduced number of LST will cut down the work load in generating data, time and man power needed and thus will permit even smaller seed companies reap the benefit of Bt technology.  This will permit more number of Bt cotton hybrids come for official testing.  This reduced expenditure in developing better Bt cotton hybrids would reduce the cost of Bt cotton seed and may reduce ‘illegal’ Bt cotton growing.

 

b.            Parameters to be monitored during LST.

 

1.         The LST field data book has been designed consisting of part A, B & C.  This would substantially simplify collection and analysis of pest-dynamics information and that of natural enemies of boll worm in part A; plant morphology and yield related information in part B and fiber/seed oil quality or industrial application in part C  (Refer Annexure-I)

 

 

c.            Number of years for LST*.

 

1.         The LST design and information on planting details are given in yield book.  AICCIP recommended fertilizer dose should be adopted.  When the GEAC cleared Bt gene’ is used in a CVRC released hybrid background to develop a new Bt cotton hybrid (para 3.15.1)  then one year of LST is enough (Figure 1). 

 

Para 3.15.1 is reproduced below:-

 

“New variant of a safe gene in CVRC released hybrid:

 

A given Bt gene family can have number of variants within it and this may not drastically change the insecticidal protein and altogether alter the manner it controls the target pest.  There are several variants within generic Cry 1Ac and are designated using subscripts as Cry 1Ac-1; Cry 1Ac-2 etc.   This indicates that these are variants of Cry 1Ac but do not have complete DNA homology, but do have some base pair differences and hence may have some variation in the protein system.  Such micro variants put together form the family and they need one year of LST if the Bt variant is in the background of a CVRC notified hybrid.”

 

2.       For GEAC cleared Bt gene (para 13.15.2) but parked in a new hybrid/variety back ground or new inter specific hybrid background, one year of LST are suggested (Figure-2). Para 3.15.2 is reproduced below:-

 

“GEAC cleared Bt gene in  new hybrids:

 

If the GEAC cleared Bt gene or its variant is used to develop a Bt cotton hybrid using a non CVRC notified hybrid as the basis, there all two years of  ICAR trials and one year of LST is needed.  It is because the public and research system never had an opportunity to asses the performance stability of the material and so needs a two year testing to assess it properly”.

 

3.         When a new variant of the GEAC approved Bt gene, that has completed biosafety and other related tests and is comparable to the GEAC cleared Bt gene for the insectical protein properties, and is developed as a Bt cotton hybrid in a CVRC released background, then one year of LST is adequate (Figure 1).

 

4.         For all other conditions* two years of LST is recommended, namely for a altogether new crop hybrid say H x B; a x a; h x a or ‘totally new gene’ or when a non CVRC approved background is used ( Figure 3).

*This category includes pyramided as well as fused genes.

 

Based on the above recommendations, the period of LST is summarized below:

 

Material

 

Bt gene

 

GEAC cleared Bt gene

Variant of the GEAC cleared Bt gene

New Bt gene/not cleared by GEAC

Pyramided genes

Fused gene(s)

CVRC approved

Hybrid

One year

One year

Two years

Two years

Two years

 

Not put up to CVRC or not approved by CVRC

 

one year

 

one year

 

Two years

 

Two years

 

Two years

 

*           As per the prevailing practice, for CVRC notified variety/hybrid containing GEAC approved transgene, one year of LST is necessary; for non-CVRC notified variety/hybrid containing GEAC approved transgene, one to two years of LST based on merit of the case and for CVRC and non-CVRC notified varieties containing new gene including fusion or pyramided two years of LST is mandatory.

 

 

d.         The stage at which seed production should be permitted.

 

1.         The best genotype should be sent to ICAR trial on the basis of performance in the MLT assessed by MEC/GEAC.  Simultaneously the LST and other seed production requirements can be approved in one go.  For seed production approval of 100 hectares for each case is recommended.

 

2.         For situations when two years of LST/ICAR are essential then for the first year seed production 10 hectares and during second year LST/ICAR trial 100 hectares can be given.

 

e.         The stage at which the Bt cotton hybrid should enter ICAR trials.

 

1.         After the MLT data is evaluated by MEC and recommended to RCGM/GEAC, the GEAC can permit the performing entry for ICAR/LST/Seed Production.  The number of years of test in this box will depend where the material falls in the above listed grouping (Figure 1, 2).

 

f.          Other recommendations

 

1.            Identifying the ‘Designated Officer’ (DO) in the SAU to monitor the MLT/LST falling in their jurisdiction is suggested.  There can be a fee levied for this purpose to meet out the cost of service extended by the SAU.

 

2.         One copy of all MLT/LST field data record, properly bound should be submitted to the concerned DO of the SAU by the agency that tests their produce apart from sending it to the Member Secretary of the MEC.

 

4.0       The recommendations of the sub-committee to the GEAC/MoEF to be operatIonalized from the time it is adopted.

 

5.0            Annexure

 

The following Annexure are attached:-

 

Annexure I: - The LST field data book containing part A, B & C as mentioned in b above.

 

Annexure II:             Figure 1:       Flow Diagram on the recommended Protocol for Released Event/Gene in CVRC notified hybrids/varieties.

 

 

Annexure III: Figure-2: Flow Diagram on the recommended Protocol for New hybrids/variety with released Event/Gene;

 

Annexure IV: Figure-3: Flow Diagram on the recommended Protocol for (i) CVRC released hybrid/variety with new gene and (ii) New hybrid /variety with new gene.

 

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All information provided in italics has been added as an explanatory note for further clarification: