You probably know by now that, on July 17, the House passed the final Senate Amendment to S. 764 by a vote of 306 to 117 (following the Senate vote of 63 to 30). And that with signed approval by President Obama, which is fully expected, the bill requires the development of a national standard for GMO labeling – pre-empting and barring any state regulations for such labeling. But, do you know exactly what the new regulation means to you and consumers? Following is a summary of the key points of the rule. The Basics
The term “bioengineering” (and any similar term) refers to a food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques, for which the modification could not otherwise be obtained through conventional breeding or be found in nature. A food derived from an animal cannot be considered a bioengineered food just because the animal consumed feed produced from, containing, or consisting of a bioengineered substance. The rule does not apply to food served in a restaurant or similar foodservice establishment. With the passage of the rule, no state or political subdivision of a state may establish or continue any requirement for the labeling or disclosure of whether a food (including that served in a restaurant or similar establishment) or seed is bioengineered or was developed or produced using bioengineering that is not identical to the mandatory disclosure requirement. So this effectively closes down the new regulations in Vermont and any other states that may be planning to do the same thing. The Timeframe
Within two years of enactment, USDA is to create a national mandatory bioengineered food labeling program, considering consistency with that of the Organic Foods Production Act. It also is to establish a process for requesting and granting a determination regarding other factors and conditions under which a food is considered a bioengineered food. The Requirements
In general, the bill requires food manufacturers to disclose the presence of bioengineered foods on product packaging. Specifically, it requires: On-package disclosure of GMO ingredients by text, a symbol, or electronic or digital link (excluding Internet website URLs not embedded in the link) with language such as, “Scan here for more food information.” Small food manufacturers also have the option to simply list a telephone number stating “Call for more food information” or an Internet website. Very small anufacturers are exempt. The electronic or digital link disclosure must be of sufficient size to be easily and effectively scanned or read by a digital device. The electronic or digital link must provide access to the bioengineering disclosure located, consistently and conspicuously, on the first product information page that appears for the product on mobile device, Internet website, or other landing page, and include a telephone number that provides access to the bioengineering disclosure. The page is to have no marketing and promotional information, nor can the electronic or digital link disclosure collect, analyze, or sell any personally identifiable information about consumers or the devices of consumers. Each food manufacturer has the prerogative to determine the disclosure option for its products. Reasonable alternative options are to be provided for food contained in small or very small packages. Non-GMO Foods
A food may not be considered to be ‘‘not bioengineered,’’ ‘‘non-GMO,’’ or any other similar claim describing the absence of bioengineering in the food solely because the food is not required to bear a disclosure. However, certification of a food under the national organic program shall be considered sufficient to make a claim regarding the absence of bioengineering in the food – which makes sense since “organic food” is not allowed to contain GMOs. Additional Notes
As with all such rules, recordkeeping will be required to be made available to inspectors on request, however the specifics of the records are to be determined as the specifics of the standards are developed. USDA is also to conduct a study, within a year after enactment, to determine any potential technological challenges consumers may face in accessing an electronic or digital disclosure. If it is determined that shoppers will not have sufficient access, then additional, comparable options for access are to be provided. Interestingly, the rule specifically states that “The Secretary shall have no authority to recall any food on the basis of whether the food bears a disclosure that the food is bioengineered.” This fits with the idea that bioengineered food does not represent any type of public health threat. While some stakeholders have criticized the rule, calling it anti-consumer, and a denial of consumer right to know, others applaud it as a “bipartisan agreement that supports science, which has shown that GMOs are safe,” and as a way of preventing a “patchwork of state laws.” From my perspective this is probably about the best outcome one could have hoped for. Food companies are not going to have to deal with individual state requirements, which, if allowed to move forward, would have had both an impact on costs of food as well as an impact on the availability of food on a state-by-state basis. The fact that this program is going to track with the USDA organic program is a strong signal that GMO food does not present any type of public health threat. If FDA were not clear about the risks of GMO food, that Agency would want control of the GMO issue. While this bill may not have given consumer organizations all they want, it is a practical mid-line solution that hopefully will put this issue to bed permanently and allow food companies to focus on real public health issues. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com