On Friday, November 2, the U.S. government joined 12 other nations in supporting policies that enable agricultural innovation, including gene editing.<\/p>\n
This support was reflected in a statement titled \u201cThe International Statement on Agricultural Applications of Precision Biotechnology,\u201d which was led by Argentina and released at a meeting in Geneva at the World Trade Organization Committee on the Application of Sanitary and Phytosanitary Measures. Both the U.S. Department of State and Agriculture issued statements, welcoming the U.S.\u2019s sign-on.<\/p>\n
The non-binding statement presents several principles that each country agrees to follow in order to create an international system that is harmonized on how to regulate products of precision biotechnology, including gene editing.<\/p>\n
The statement is in response to frequent regulatory roadblocks that companies can face when developing agricultural applications of precision biotechnology \u2013 whether for plants or animals.<\/p>\n
Gene editing can create highly beneficial products to more quickly meet consumer and societal needs by using the natural potential within an organism, without introducing any foreign DNA.\u00a0 Examples include healthier cooking oils from gene edited crops and disease resistant, enhanced welfare animals.\u00a0 In many instances, identical products could be achieved using traditional breeding and brought straight to market, but if the same product was made through a gene edit it may be met with increased regulatory process simply because of the difference in method to achieve the same result.<\/p>\n
By aligning regulatory approaches across the globe, the U.S. hopes to create an international regulatory environment that does not hinder agricultural products just because they were developed through gene editing as opposed to conventional breeding.<\/p>\n
Here in the U.S., USDA has taken a science-based regulatory approach to gene edited plants because the agency understands that many of these products are the same as those developed through conventionally breeding \u2013 just using a modern and more precise method.<\/p>\n
In a statement published in March, USDA stated with respect to pre-market regulatory approval processes \u201cUSDA does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional [conventional] breeding techniques\u2026\u201d.\u00a0 USDA still retains the authority to regulate many of these products once in the market if any problems should arise.<\/p>\n
But USDA isn\u2019t the only U.S. agency with some oversight of products of agricultural innovation.\u00a0 The Environmental Protection Agency and the Food and Drug Administration may have a role to play, too, and the picture at USDA\u2019s sister agencies isn\u2019t very clear.<\/p>\n
The Environmental Protection Agency takes responsibility in regulating plants that have been developed to carry pesticide-like traits (plant incorporated protectants) \u2013 but not if achieved through conventional breeding.<\/p>\n
Recently, EPA noted they are evaluating gene editing technology and whether such products should fall within their oversight. So, the question becomes: Will they regulate gene edited plants that are identical to those made through conventional breeding? We don\u2019t know, but if they do it would conflict with the international statement that the U.S. has signed on to.<\/p>\n
As the International Statement states, \u201cIn either case [whether through conventional breeding, transgenic mutation or gene editing], the food, animal, and environmental safety of such products can be adequately addressed by existing regulatory frameworks for agricultural products and existing safety standards based on the characteristics of the product or organism.\u201d<\/p>\n
Translation: plants with pesticide-like characteristics developed through gene editing should be judged on what they are as a product and not on the method to achieve them.\u00a0 And since the product in many cases will be the same as ones that already exist or that could be created through traditional methods, they should be treated the same way from a regulatory perspective.<\/p>\n
Therefore, EPA should not be regulating plants just because they were made through gene editing. If they were to follow the international statement, they would be more aligned with USDA\u2019s approach: they would not require a pre-market approval process for products identical to those that could be created through traditional methods but would retain the authority to regulate if a problem arose.<\/p>\n
The U.S. Food and Drug Administration may also have role to play in oversight of products of agricultural innovation.\u00a0 For plants, FDA has not yet publicly stated how it intends to oversee products developed using gene editing.\u00a0 Regarding gene edited animals, the FDA has carved out a regulatory position that treats these products as \u201cnew animal drugs,\u201d a stance that is arguably inconsistent with the recent international statement.<\/p>\n
However, the FDA recently announced a \u201cPlant and Animal Biotechnology Innovation Action Plan,\u201d which the agency says, \u201caims to implement and clarify risk-based policies with the goals of ensuring that developers know what they need to do to efficiently bring a product to market.\u201d Through this program, BIO hopes the agency will establish a right-sized regulatory approach for gene editing, similar to that of USDA and consistent with the broader international statement<\/p>\n
The international statement was drafted because gene editing is so new, and the international community has yet to get on the same page as to how to establish appropriate oversight.\u00a0 BIO strongly supports the principles articulated in the international statement and encourages the adoption of these principles by governments around the world\u2014including our own.<\/p>\n","protected":false},"excerpt":{"rendered":"
On Friday, November 2, the U.S. government joined 12 other nations in supporting policies that enable agricultural innovation, including gene editing. This support was reflected in a statement titled \u201cThe International Statement on Agricultural Applications of Precision Biotechnology,\u201d which was led by Argentina and released at a meeting in Geneva at the World Trade Organization […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_seopress_robots_primary_cat":"","nova_meta_subtitle":"","footnotes":""},"categories":[5572],"tags":[5796,15236],"supplier":[2194,9223],"class_list":["post-59429","post","type-post","status-publish","format-standard","hentry","category-bio-based","tag-biotechnology","tag-geneediting","supplier-biotechnology-innovation-organization-bio","supplier-u-s-government"],"_links":{"self":[{"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/posts\/59429","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/comments?post=59429"}],"version-history":[{"count":0,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/posts\/59429\/revisions"}],"wp:attachment":[{"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/media?parent=59429"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/categories?post=59429"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/tags?post=59429"},{"taxonomy":"supplier","embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/supplier?post=59429"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}