FDA Issues

Were you interested in submitting comments for the draft documents regarding Environmental Assessment (EA) and preliminary Finding of No Significant Impact (FONSI)? Specifically, those pertaining to AquaBounty Technologies’ application for AquAdvantage Salmon? If so, you’re in luck! The U.S. Food and Drug Administration announced today that it is extending the comment period for another 60-days. The comment period was supposed to conclude on Feb. 25, 2013. Now, the comment period runs until April 26, 2013.

AquAdvantage salmon is the trade name for a genetically modified Atlantic salmon developed by AquaBounty Technologies. The AquAdvantage salmon has been modified by the addition of a growth hormone regulating gene from a Pacific Chinook salmon and a promoter gene from an ocean pout to the Atlantic’s 40,000 genes. These genes enable it to grow year-round instead of only during spring and summer. The purpose of the modifications is to increase the speed at which the fish grows, without affecting its ultimate size or other qualities. This allows producers to supply enough salmon for the large quantity of year-round purchasers and consumers to enjoy a quality product.

The draft EA and preliminary FONSI are one step in FDA’s evaluation of the AquAdvantage Salmon and do not indicate an approval of the application. The National Environmental Policy Act of 1969 (NEPA) requires FDA and other federal agencies to perform such assessments whenever a major Federal action is taken. Comments made regarding these documents could potentially benefit […]

On February 4, 2013, the FDA announced the final rule amending the criteria for administrative detention to prevent potentially unsafe food from reaching the marketplace. This change follows the changes to the Federal Food, Drug, and Cosmetic Act under the Food Safety Modernization Act. The final rule adopts the same policy that was implemented by the interim final rule without any change. The interim final rule was published in May 2011. This rule became effective in July 2011. The interim final rule amended the criteria for ordering administrative detention.  This rule permits the FDA to administratively detain food it believes is adulterated or misbranded.

 Prior to the enactment of the Food Safety Modernization Act, the FDA was able to detain a food product only when it had credible evidence that a food product presented a threat of serious adverse health consequences or death to humans or animals. The final rule loosens the parameters of the previous regulation and allows the FDA to detain food that it believes is adulterated or misbranded. The agency can keep the products out of the marketplace for a maximum of 30 days while the agency determines whether it will be taking further enforcement action. Further enforcement action may include the seizure of the goods. This new rule could cause difficulties in the importation of your product. Please contact me now so that I may inform you what your options are to avoid any potential issues that may arise due to the enactment […]