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Dairy Facts 2016

FDA Releases Final Guidance on Genetically Engineered Animals

Jan 19, 2009

The Food and Drug Administration last Thursday issued its final regulatory guidance on genetically engineered animals. The guidance confirms FDA's intention to use the New Animal Drug Application process to review GE animals and animal products, an approach that was supported by IDFA as well as the National Milk Producers Federation and U.S. Dairy Export Council.

"We support a rigorous review process by the government on genetically engineered animal applications," said Clay Hough, IDFA senior group vice president. "Establishing a thorough process during this early period will be critical, particularly as it applies to any future applications involving food."

On labeling, FDA says it will not ask producers to indicate that the food comes from GE animals and will only require special labeling if there is a material difference in the composition of the food. The dairy industry is not currently aware of any application before FDA regarding GE dairy cows.

The final rule also includes a change to increase the transparency of deliberations on these new products. IDFA had recommended this step in its comments to assure public confidence in the agency's decision.

"We will continue to work closely with FDA and other agencies to encourage steps that will reassure consumers about the continued health, safety and highest quality of U.S. dairy products," said Hough.

The release of the final guidance is a follow-up to FDA’s draft guidance, which was released last September and was followed by a 60-day public comment period. The agency received and reviewed about 28,000 comments before making its decision.


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