WASHINGTON, Feb. 22, 2016 - New guidance from the Animal and Plant Health Inspection Service (APHIS) seeks to streamline the process of extending nonregulated status to genetically engineered (GE) organisms and products derived from known plant pests, or regulated articles.

Entitled “Extension Guidance for Developers,” the APHIS document said it anticipated the process being applicable in the following cases:


“1) Where a previously reviewed trait is introduced into different varieties of the same crop. For example, various apple varieties genetically engineered with the same non-browning trait as in one of the antecedent Arctic apple events in ‘Golden Delicious’ and ‘Granny Smith’ varieties (10-161-01p).

 “2) Where traits previously reviewed separately in a particular crop are stacked into the same crop by introducing them together through genetic engineering. For example, a stacked corn line is created by introducing both a mepsps gene (previously reviewed in corn) and a cry gene from Bacillus thuringiensis (previously reviewed in corn). In this case there will be two or more antecedents.

“3) Where phenotype categories have been reviewed previously in the crop but a mechanism-of-action new to the crop has been reviewed in another crop. For example, if the hppd gene, which confers resistance to mesotrione herbicide, is introduced in corn (hppd was previously reviewed in soybean and many herbicide-resistant corn lines have been reviewed). In this case there will be two or more antecedents.


The guidance said that while each of the three cases is eligible for the extension process, “the similarity of the product being considered for an extension (potential extension) to the antecedents decreases from case 1 to case 3. Consequently the timelines for review may become longer as the degree of similarity decreases.”

“There may be instances in case 3 where issues are different enough between the potential extension and the antecedent organism(s) that APHIS determines that the extension process is not appropriate and the petition process should be used. Also, because the potential extension is somewhat different, previous NEPA analyses may not be sufficient and additional analyses may be required. Nevertheless, APHIS believes that most products that meet one of the three criteria are likely to qualify for the extension process, and that the review will be completed within eight months after receiving a complete dossier.”

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The Biotechnology Innovation Organization reacted favorably to the announcement by APHIS. “We are pleased that APHIS has published new guidance on the expanded use of the extension process,” BIO spokesperson Karen Batra said. “The new guidance encourages developers to use this regulatory review mechanism for faster, more predictable review of products with which APHIS already has a great deal of familiarity, while still ensuring a rigorous safety review.”


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