Pending patent lapses along with existing regulatory models create bottlenecks to innovation…

March 30, 2011

I just finished up a draft report for the SaskFlax Executive on low level presence (LLP) policy in Canada.  During Crop Production Week in January, we (me along with SaskFlax) hosted a Focus Group discussing the issue of LLP and policy in Canada.  This Group consisted of a number of industry and government stakeholders and, with the help of their expert opinions and a little research, I was able to pull together a nice little piece for the SaskFlax board (FYI, this will be available for public consumption at a later date).

Did you know that Canada, like the EU, currently has a zero tolerance policy for low level presence of unapproved events? Mind you, Canada’s zero tolerance policy is not nearly as ‘aggressive’ as that of the EU as it operates under a case-by-case, market-impact-minimizing paradigm. However, as one of our industry interviewees (yes, we conducted one-on-one interviews as well) states: “…[This policy] seems hypocritical… [we expect] the EU soften its position… while Canada, itself, still operates under a zero tolerance policy…” 

Fair enough. A low level presence policy in Canada (and all countries for that matter) appears to be an important step in ensuring that trade continues unimpeded amongst all countries.

For those of you that may be unfamiliar with the term (or confused by it – you are not alone in this, by the way), ‘low level presence’ or LLP is defined by the International Grain Trade Coalition (2008) as:

“…[T]he adventitious presence of biotechnology-derived plant material in imported commodities that has undergone a full safety assessment…and been authorized for use in food, feed, grain and derived products by the competent government authority in one or more countries, including the country of cultivation.”

‘Low level Presence’ assumes approval of the trait or biotechnology-derived material in at least one country.

LLP is not a new issue, but it is an important one. You only have to look at the case of Canada and the EU where several thousand tons of flax was quarantined when traces of the GM flax, Triffid (and, yes, it was approved for feed and food in both Canada and the US) was found in shipments in EU ports in 2009 (for more on this, check out a few of these blog entries or search my site on the term “Triffid”.

International efforts in establishing guidelines for LLP have been in the works for a few years now. The notion of internationally, harmonized guidelines is the goal. Nature Biotechnology published The International Seed Federation’s ‘call to action’ and the importance of establishing international guidelines for the regulation of LLL (ISF 2008):

“The issue of low-level presence of biotech traits needs to be solved rapidly. If it is not, grain and seed shipments will continue to be stopped at ports, international trade will be jeopardized, the cost of food and feed will increase significantly in many countries, and plant breeding and seed supply efforts will be seriously hampered.” (161)

Why does this matter?  Well, I could go on, but I will let some other experts do the talking.  Amongst the many good points they make in this Forbes article, Henry Miller and Drew Kershen encourage the establishment of sensible “tolerance levels” for unapproved varieties.  They discuss this issue (and others) in the context of pending patent lapses related to key crop varieties.  In particular, the authors highlight how – in the event of patent expiration – existing regulatory models as they are currently structured will inevitably create huge bottlenecks for agriculture and for trade.  This is bad for everyone. Have a look at “Innovation Arrested by the Law of Unintended Consequences.” http://blogs.forbes.com/henrymiller/2011/03/30/innovation-arrested-by-the-law-of-unintended-consequences/

References:

International Grain Trade Coalition (IGTC). (2008).  “Risk Management Guidance for Setting Low Level Presence (LLP) Thresholds for rDNA Plant Material in Bulk Grain and Grain Products Shipments.” Accessed on December 20, 2010.  Available online at: http://www.igtcglobal.com/files/news/28082008.pdf.

International Seed Federation. (2008). “Action needed to harmonize regulation of low-level presence of biotech traits.” In Nature Biotechnology Correspondence. Pps 161-162.  Available online at: http://www.cof.orst.edu/cof/teach/agbiotox/Other%20Readings/Action_low-level_biotech_NatBiotech2008.pdf

 

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