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BIO Comments to FDA on Genome Editing in New Plant Varieties Used for Foods

BIO appreciates this opportunity to provide comments to the Food and Drug Administration (FDA) on its request for comments on genome editing in plants.

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Submitted Electronically via Federal eRulemaking Portal
(http://www.regulations.gov)

Re: Docket Number: FDA-2016-N-4389; Genome Editing in New Plant Varieties Used for Foods; Request for Comments1

Dear Dr. Kux:

The Biotechnology Innovation Organization (BIO) appreciates this opportunity to provide comments to the Food and Drug Administration (FDA) on its request for comments on genome editing in plants. BIO is the world's largest biotechnology trade association, representing small and large companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products. BIO represents its members in a number of matters related to agricultural biotechnology, and in particular, has a strong interest in the sound regulation of plant biotechnology.

BIO fully supports the comments to this docket submitted by the American Seed Trade Association (ASTA), and we reference those comments a number of times in this document. In addition to voicing our full support for the comments submitted by ASTA, BIO adds the following.

INTRODUCTION

This is a critical time in the development of the newest biology-based technologies: an array of genome editing techniques that target sites in an organism’s genetic material with remarkable precision. They represent the next step in a continuum of genetic modification methods that began thousands of years ago with the simple process of artificial selection: humans, rather than nature, decided which wild plants would reproduce by preferentially planting certain seeds from the progenitors of today’s crops. Analogous to evolution by natural selection, artificial selection preserves only certain of the genetic variants, which are derived from spontaneous mutation and nature’s random mating processes, then discards others and, in the process, changes the gene frequencies in the population under selection.

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