Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 32 Page 33 Page 34 Page 35 Page 36 Page 37 Page 38 Page 39 Page 40 Page 41 Page 42 Page 43 Page 44 Page 45 Page 46 Page 47 Page 48 Page 49 Page 50 Page 51 Page 52 Page 53 Page 54 Page 55 Page 56 Page 57 Page 58 Page 59 Page 60 Page 61 Page 62 Page 63 Page 64 Page 65 Page 66 Page 67 Page 68 Page 69 Page 70 Page 71 Page 72 Page 73 Page 74 Page 75 Page 76 Page 77 Page 78 Page 79 Page 80 Page 81 Page 82 Page 83 Page 84 Page 85 Page 86 Page 87 Page 88 Page 89 Page 90 Page 91 Page 92 Page 93 Page 94 Page 95 Page 96 Page 97 Page 98 Page 99 Page 100 Page 101 Page 102 Page 103 Page 104 Page 105 Page 106 Page 107 Page 108 Page 109 Page 110 Page 111 Page 112 Page 113 Page 114 Page 115 Page 116 Page 117 Page 118 Page 119 Page 120 Page 121 Page 122 Page 123 Page 124 Page 125 Page 126 Page 127 Page 128 Page 129 Page 130 Page 131 Page 132 Page 133 Page 134 Page 135 Page 136 Page 137 Page 138 Page 139 Page 140 Page 141 Page 142 Page 143 Page 144 Page 145 Page 146 Page 147 Page 14822 / SEEDWORLD.COM DECEMBER 2016 Hope for Improved Policy Now, as newer technologies like genome editing come to market, the U.S. govern- ment must decide whether a pre-market review and approval process will be placed upon plant varieties developed through those techniques. The American Seed Trade Association argues it should not for certain applica- tions of genome editing. “If you can get to the same product end point through traditional breeding, we don’t think those products should fall under the existing biotech regulation,” says Slutsky. “You have to ask: is there a reason, from a scientific and risk basis, for applying the special pre-market approval process to these newer categories of products? “We would say no. What we are doing is essentially what plant breeders have always done, which is creating genetic diversity and variation within a plant’s gene pool.” Batra says stakeholder groups such as BIO are committed to staying engaged in the rule-making process as USDA’s Animal and Plant Health Inspection Service (APHIS) works to amend the 7 CFR Part 340 regulations for biotech products. “Some of the recommendations we’ve made include amending the regulatory process so that it’s more science- and risk-based and making the review pro- cess more timely and predictable so seed developers are aware of the process and time frame going in,” she says. If federal regulators have previously approved a herbicide-tolerant soybean, it should take them less time to review additional soybean varieties that come before them, particularly if they possess the same technology, Batra adds. Uncertainty Looms Part of the significant uncertainty sur- rounding how the regulatory environ- ment might affect up-and-coming plant breeding technologies is due to the uncertainty surrounding the existing regulations themselves. “We are in a situation across govern- ments where the existing regulations for GMOs are currently not at all consistent with each other. There are different defini- tions, different legal frameworks around the world. What we hope will happen is, both domestically and internationally, that governments will have an active dialogue with each other in order to work toward consistent policies,” says Slutsky. Of course, clarifying our domestic regulatory environment is only the first component in today’s highly inter-con- nected international reality. “The seed industry and agriculture in general are global industries. We can’t just consider the U.S. regulatory process. We have to consider the cost of compli- ance across all of our major markets,” says Slutsky. “I’m not saying it is going to be an easy path forward to get to that level of consistency, but I think there is some oppor- tunity there and this is a priority for both the U.S. seed sector and global seed sector.” For this reason, engaging trading partners on agricultural innovations, encouraging them to solidly define their own regulations, and working with them toward minimizing international restric- tions on new technologies must also be a priority. Bradford says he’s optimistic that new, innovative breeding techniques will lift the industry over the hurdles they face. Plant scientists are encouraged that USDA has decided that some applications of new gene editing technology, such as CRISPR, fall outside of their regulatory authority. “Companies have been sitting and waiting for regulations to change,” says Bradford. “But these innovative breeding methods will result in new opportunities for product development. It depends on whether this distinction between gene transfer and gene editing will hold up through the rule-making process.” SW TIMELINE OF GMOS/BIOTECH IN THE SPOTLIGHT EPA, FDA and USDA unveiled two documents as part of the effort to modernize the biotech regulatory system. Feb. 27 March 25 July 2 July 23 Feb. 5 March 1 July 1 July 14 July 29 Sept. 16 In a stakeholder message, USDA’s Animal and Plant Health Inspection Service withdrew its 2008 proposed ruled that would have amended the regulations for certain genetically engineered organisms. Representative Mike Pompeo (R-Kan.) introduced into the House the Safe and Accurate Food Labeling Act of 2015. The White House issued a memorandum directing the three federal agencies that have oversight responsibilities for biotech products to develop a long-term strategy to ensure that the system is prepared for future biotech products. The House voted to pass the Safe and Accurate Food Labeling Act. 2015 2016 APHIS published a notice in the Federal Register announcing that it is developing a draft programmatic environmental impact statement that will evaluate a range of alternatives tht the agency can take as it works to update its biotechnology regulations. Senator Pat Roberts (R-Kan.) introduced legislation that creates a federal standard for GMO labeling. Vermont’s first-in-the-nation mandatory GMO labeling law went into effect. Senate gives final Congressional approval on federal GMO labeling bill. President Barack Obama signed into law a bill that creates a federal standard for the labeling of foods containing ingredients derived from GM crops. “I’m not saying it is going to be an easy path forward to get to that level of consistency, but I think there is some opportunity there and this is a priority ...” — Bernice Slutsky