USDA to ‘cut in half’ Regulatory Approval Timelines for Biotechnology Products
16 March 2012 - Rubicon informed the market today of important changes that have been made to the regulatory approval process for biotechnology products in the US, which will be applicable to its biotechnology investment (ArborGen). These changes are designed to streamline and shorten the timeline to achieve deregulation petition determinations (i.e. regulatory approval decisions in respect of the commercial release) of biotechnology products.
Determination timelines under the previous process, which is operated by the US Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS), have, over the past decade, extended to more than three years per petition on average. The new process outlined by APHIS this month, is designed to shorten this determination period to only 13-16 months, and importantly, will do so without reducing the quality of the environmental review undertaken or of the final assessment made.
This process improvement has been achieved by moving the initial public comment period to the beginning of APHIS’s review rather than after its environmental assessment report is made public as was previously the case, and also through internal process changes that will now allow petition applications to be declared complete (i.e. no further information required from the applicant) by APHIS within 90 days of their receipt
When talking to the changes, Mr. Michael Gregoire, a USDA Deputy Administrator, said that taking public comments on petitions for deregulations at the start of the review process would allow the USDA to address concerns early, improve the quality of the decisions made, and help get new technologies on the market sooner.
Andrew Baum, president and CEO of ArborGen said, “These process improvements announced by APHIS represent a significant improvement to the regulatory approval process previously in place, and these changes will be welcomed by the wider biotechnology community. The new process should achieve faster petition determinations without foregoing any of the rigour of APHIS’s environmental assessment process. It is an excellent step forward for all stakeholders, and ArborGen remains committed to work with USDA to ensure efficient and timely approval of future biotechnology products under this streamlined process.”