A Blizzard and a Regulatory Freeze For those in the Midwest today, I hope you are staying warm & are ready for the predicted snowfall and wind gusts currently in progress. There’s been a lot of news in recent months about agricultural biotechnology regulatory changes underway at various stages of public comment and implementation (7 CFR part 340, proposed EPA rules […] Read Post →
EPA Provides Draft Guidance for Regulation of Gene Edited Plants Background Although the USDA gets the most attention related to the regulation of gene edited plants, in the United States products of biotechnology are regulated by the USDA, FDA and EPA under the Coordinated Framework for the Regulation of Biotechnology, updated most recently in 2017. Under this framework, the USDA, FDA and EPA each regulate in […] Read Post →
USDA’s new Part 340 and impact on gene edited plants The USDA published a new version of agricultural biotechnology regulations (7 CFR Part 340, aka “Part 340”) which is the culmination of several years of revision and public review. In this revised rule, which will begin implementation 90 days from May 18th, developers now have more definitive guidelines on where plants will be exempt from […] Read Post →
Farm Bill Amendments to Enable CBD Oil and Hemp Industry On June 27th, the Senate published the latest version of amendments to the Farm Bill which contain updates to the regulatory framework for hemp and derived products including CBD (cannabidiol) oil. Cannabidiol oil has documented health benefits such as effectiveness in treating certain types of seizures, and the U.S. Department of Health and Human Services […] Read Post →
National Bioengineered Food Disclosure Standard rules publish May 4: Ties to patent protection and gene editing National Bioengineered Food Disclosure Standard rules publish May 4: Ties to patent protection and gene editing In 2016 Congress passed an amendment to the Agricultural Marketing Act of 1946 to establish a national bioengineered food disclosure standard. This law was an important milestone in establishing transparency for consumers, ensuring labeling certainty for innovators developing […] Read Post →
Patent Covering Methods of Advanced Genomic Selection from Guinea Pigs to Corn Survives Opposition in EU Effectively protecting improved genetics requires a multi-pillared strategy considering the biological organisms themselves, methods of use, methods of breeding, and any regulatory data protection. The EPO recently upheld a patent (EP 2813141, granted August 5, 2015) drawn to methods of breeding using genome-wide estimated breeding values (EBVs) to identify combinations of individuals in a population […] Read Post →