The U.S. Department of Agriculture is close to issuing its final rule for the National Bioengineered Food Disclosure Standard, aka GMO labeling.
A proposed rule was issued on May 3, 2018, with a 60-day comment period that closed on July 3, 2018.
The rule is an outcome of a July 2016, Congressional Amendment to the Agricultural Marketing Act of 1946. As you may recall, Vermont had enacted legislation that required all food producers to disclose whether they had genetically modified organisms in their products, with an effective date of July 1, 2016. The Vermont law was a challenge for large and small food manufacturers and distributors, many of whom were not pleased with creating a different label based on state law.
With support from the Grocery Manufacturers Association, Food Marketing Institute, and others, Congress passed a law that preempted state laws, including Vermont's. It requires that food manufacturers disclose the presence of bioengineered ingredients, but it allows this information to be communicated in many different ways and provides extensions and exemptions for small food manufacturers, very small food manufacturers, and most retailers. The rule is being administered by the USDA's Agricultural Marketing Service.
The Proposed Rule
The proposed rule, which runs 106 pages, is “intended to provide for disclosure of foods that are or may be bioengineered in the interest of consumers, but also seeks to minimize implementation and compliance costs for the food industry—costs that could be passed on to consumers.” Food that is sold for human consumption is covered by the rule; food for animals is not. The rule covers food, beverages, and ingredients. If a protein covered by the Federal Meat Inspection Act, Poultry Products Inspection Act, or the Egg Products Inspection Act is the first ingredient in the ingredient listing, bioengineered labeling is not required. In other words, a pork product that is produced from pigs that are fed GMO corn does not have to state that GMOs are in the product.
There are four food ingredients that are likely to be genetically modified, including canola (90 percent); field corn (92 percent); soybeans (94 percent); and sugar beets (100 percent).
Five genetically modified crops are not considered highly adopted because their market prevalence is below 85 percent. These include non-browning apples; sweet corn; papaya; potato; and summer varieties of squash.
AMS recognizes that these lists will change in the future as the biotech industry develops more products.
The Exemptions
There are two exemptions to the disclosure requirement: food served in a restaurant or similar food establishment and very small food manufacturers. These exemptions cover many SFA members.
Few retailers will be required to label GMOs. The exemption broadly defines “similar food establishment” as “a cafeteria, lunch room, food stand, saloon, tavern, bar, lounge, other similar establishment operated as an enterprise engaged in the business of selling prepared food to the public, or salad bars, delicatessens, and other food enterprises located within retail food establishments that provide ready-to-eat foods that are consumed either on or outside the retailer’s premises.”
In other words, a supermarket or specialty food store that produces food, such as a corn relish, would not need to label it as bioengineered. However, products on the shelves that come from other manufacturers do need to be labeled. AMS has requested comments on this exemption and SFA has said that it is broad enough to cover the specialty food industry.
The exemption which is most important to the specialty food industry is for “very small food manufacturers.” The AMS defines very small food manufacturers as those with annual receipts of less than $2.5 million. This number is inconsistent with the definition of very small business used by the FDA for nutritional labeling, the Food Safety Modernization Act, and other FDA regulations. For nutritional labeling, FDA exempts companies with less than $100,000 in annual sales; for FSMA, less than $1 million in annual sales. SFA would prefer that the definition of very small business for GMO labeling be consistent with FDA’s, and has stated that $1 million is more appropriate than $2.5 million.
AMS employed a statistical method to arrive at its $2.5 million figure. According to methodology based on the 2012 Statistics of U.S. Businesses, 74 percent of food manufacturers would be exempt at $2.5 million, which would equate to 4 percent of products and just 1 percent of food sales.
The $1 million figure would exempt 54 percent of manufacturers, 2 percent of products, and 1 percent of food sales. AMS says that $2.5 million “offers significantly greater relief for small manufacturers while still having a relatively minor impact on the amount of information available to consumers.”
The Disclosure
The Act explicitly states that food with GMO ingredients is not more or less safe than food without GMO ingredients. Three primary options for disclosure are provided, as well as alternative disclosure options for food in small or very small packages. There are three entities responsible for disclosure: food manufacturers; importers; and certain retailers.
The retailer would only be responsible if it packages food that is not part of fresh food prepared in store.
Importers are subject to the same disclosure standards as domestic food manufacturers and must disclose if there are GMOs in the food. If the food would be expected to have a GMO ingredient, such as corn or soy, the importer needs to have records that prove that there are no GMOs in the product. AMS states that it may recognize standards in equivalent countries, based on whether the country has mandatory BE labeling, what threshold requirement is proposed, and what food products in that country are subject to BE labeling.
How to Disclose
One option for BE disclosure is by text. AMS proposes using the terms “bioengineered food” or “bioengineered food ingredient” in that those are the terms in the legislation. It states that the alternative terms “genetically modified” or "genetically engineered” food should not be used. SFA strongly opposed this approach in its comments because “genetically modified” or “GMO” are the common terms understood by the food industry and consumers.
Text disclosure must be on the information panels, the principal display panel, or on an alternative panel if neither the information or principal display panel work. The information panel includes the nutrition facts, the ingredient list, and the manufacturer name and address. The principal display panel is where the statement of identity and net quantity statement are located. AMS recommends that the information panel be utilized but says that it also wants to provide flexibility to industry. The text needs to be of sufficient size and clarity to be understood by consumers.
Symbols are another means to communicate the presence of a bioengineered food or ingredient. AMS is proposing three symbol versions which are designed to “communicate the bioengineered status of a food in a way that would not disparage biotechnology or suggest BE food is more or less safe than non-BE food.”
These symbols can also be printed in black and white if a manufacturer was concerned about design or printing cost.
In its statement, SFA strongly opposed these symbols. The Association believes that the symbols are not strictly informative and that they convey that the GMO products are from nature and imply that they are healthy and better for you.
The final recommended disclosure option is via electronic or digital link. These would most likely be QR codes that can be scanned by a smart phone. There would also need to be text that says, “Scan here for more food information.” The disclosure would need to be on the first product information page provided by the link, without any marketing or promotional material and would need to conform to the size requirements of text or symbol disclosure.
An alternative is via text message. The package would need to state “Text ‘number’ for more information.”
Disclosure for Small Food Manufacturers
AMS is providing two additional disclosure options for small food manufacturers, which are defined as manufacturers with more than $2.5 million but less than $10 million in annual receipts. Small food manufacturers would also receive a one-year extension to comply beyond the initial date.
Small food manufacturers could disclose via a telephone number or website. The telephone number would need to say, “Call for more food information.” A recorded message is acceptable but the notification of the presence of GMO materials would need to be communicated before any marketing or promotional information. Similar rules would apply to a website.
For small packages, manufacturers could use a modified version of the electronic or digital link, a modified version of the text message, or a modified version of the telephone number option.
USDA and AMS received tens of thousands of comments on the proposed regulation by the July 3 deadline. As they review industry and consumer input, some of the bioengineering implementation regulations could alter, but the law will not. The specialty food industry should prepare to compl
AMS is proposing these symbols to communicate the status of BE foods in a non-disparaging way.
Ron Tanner is vice president, philanthropy, government, and industry relations for the Specialty Food Association.
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