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BIO Letter to Agriculture Secretary Mike Johanns

March 10, 2016

Dear Secretary Johanns:

On behalf of the Biotechnology Industry Organization (BIO), I request your support for publication of the U. S: Food and Drug Administration's (FDA) draft risk assessment on the safety of livestock cloning.

We ask that USDA expedite final steps of the interagency review of the draft risk assessment, so that timely coordination with, and public release by, FDA is facilitated. The Biotechnology Industry Organization (BIO) represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. States and 31 countries. BIO members are involved in the research and development of health care, agricultural, industrial and environmental biotechnology products.

As providers of this assisted reproductive technology, BIO members are the world's leaders in livestock cloning. Delayed publication of the draft risk assessment will negatively impact their business in terms of future investment in the technology and direct product sales. The draft risk assessment is an important step in a series toward finalizing the science-based decision that foods from cloned animals and their progeny are as safe as meat and milk from traditionally bred animals. Based on decades of scientific research, including recent extensive data from international institutions and specific studies designed in cooperation with FDA by BIO members, the safety of livestock cloning has been well established.

The benefits of cloning to breeders, farmers and consumers are part of an evolution of assisted breeding techniques over decades. With this technology, we may be able to breed healthier animals and produce improved food products that meet consumer demands of safety, quality and consistency.

BIO urges the Administration to publish the FDA draft risk assessment as soon as possible to assure livestock producers of predictable markets, promote consumer understanding of the technology, and allow U.S. companies to pursue business opportunities. We appreciate USDA's leadership in support of this effort.


James Greenwood
President and CEO

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