USDA: India agricultural biotechnology 2014

Agricultural trade between the United States and India was estimated at about $5.6 billion in calendar year (CY) 2013, although the balance of ag trade balance was skewed roughly 5.5 to 1 in India’s favor. Soybean oil derived from glyphosate-tolerant soybeans is the only biotech food/agricultural product currently approved for import. In CY 2010, U.S. soybean oil exports to India reached a record $132.9 million. However, this trade has since declined significantly and reached only $28.3 million in CY 2013. 

 

Bt cotton is the only GE crop currently approved for commercial cultivation in India. Since 2002, the Government of India (GOI) has approved six Bt cotton events and nearly 1,100 Bt cotton hybrids and varieties for commercial cultivation.

 

The 1986 Environmental Protection Act (EPA) provides the foundation for India’s biotechnology regulatory framework for GE plants and their respective products. Per current Indian regulations, all biotech food/agricultural products, or products derived from biotech plants and/or other organisms must receive formal approval from the Genetic Engineering Appraisal Committee (GEAC) prior to commercialization or imports (the GEAC is India’s apex biotech regulatory body). On April 22, 2013, the DBT submitted the “Biotechnology Regulatory Authority of India Bill 2012” (BRAI) to the Parliament of India, which has been subsequently referred to the Parliament’s Standing Committee on Science, Technology, Environment and Forests for review and consultations with stakeholders. However, to date the BRAI bill still has not been formally introduced to the Parliament for approval. The BRAI bill proposes setting up an independent and autonomous national biotech regulatory authority for biosafety clearance of genetically engineered products and processes.

 

The Food Safety and Standards Act of 2006 includes specific provisions for regulating GE food products, including processed foods. However, the apex regulatory body under the Act, the Food Safety and Standard Authority of India, is still in the process of formulating specific regulations for overseeing GE food products. Consequently, the GEAC continues to regulate processed food products (containing GE ingredients) under the 1989 Rules.

 

India’s biotech regulatory policy environment from 2010 through early-2014 severely hampered approvals for new events, many of which were at advanced stages of regulatory approval. On February 9, 2010, the Ministry of Environment and Forest (MOEF) announced a moratorium on the approval of Bt brinjal (eggplant). On July 6, 2011, the GEAC introduced new procedures for authorizing biotech crop field trials, requiring applicants (technology developers) to obtain a ‘no objection certificate’ (NOC) from the relevant state government. This decision has hampered ongoing field trials as only a few states (Punjab, Haryana, Gujarat, Andhra Pradesh and Maharashtra) have issued NOCs. 

 

The functioning of GEAC was effectively suspended for nearly two years from April 2012 through March 2014. After the resignation of the former Minister of Environment and Forest in December 2013, and the subsequent appointment of her successor, the GEAC was revived and reconvened on March 21, 2014. During its first official meeting, it approved field trials for several new crop events, followed by subsequent monthly meetings, and additional approvals, in April and May. Although the GEAC was not convened in June following the formation of the newly elected National Democratic Alliance (NDA) Government, it is scheduled to reconvene on July 17, 2014. Post expects that that India’s new government is likely to continue with the regular monthly GEAC meetings.

 

In May, 2012, the Supreme Court (SC) of India appointed a Technical Expert Committee (TEC) to review and recommend biosafety risk assessment studies for GE crops. On July 18, 2013, five members of the six-member TEC submitted its final report and recommended a ban on all GE crop field trials until the gaps in the existing biosafety regulatory system are addressed. However, one member of the TEC submitted a separate report recommending the continuation of field trials while the GOI addresses regulatory shortcomings. The GOI and industry stakeholders strongly contested the five-member TEC’s recommendation immediately following its issuance, as well as during subsequent hearings in August 2013, April and May 2014. The next SC hearing on the case is scheduled for July 15, 2014, but the Court’s final verdict may take additional time (perhaps months) after the July reconvening.

 

Most local biotech stakeholders remain cautiously optimistic that ongoing field trials are likely to continue. Moreover, the newly elected NDA Government has stated support of adopting new agricultural technologies. While the SC verdict may ultimately foment changes to India’s biotech regulatory system, the pendulum seems to be swinging back towards a more progressive regulatory environment.