The U.S. Department of Agriculture has rolled out one of the final steps in establishing a new food labeling law. On Thursday, the agency published a proposed final rule to establish the National Bioengineered Food Disclosure Standard (NBFDS) mandated by Congress in 2016.

The standard will provide a uniform way to offer meaningful disclosure for consumers who want more information about their food and to avoid a patchwork system of state or private labels that could be confusing for consumers and would likely drive up food costs.

USDA invited public comment on the proposed rule. “This rule-making presents several possible ways to determine what foods will be covered by the final rule and what the disclosure will include and look like,” Agriculture Secretary Sonny Perdue said. “We are looking for public input on a number of these key decisions before a final rule is issued later this year.”

The Agricultural Marketing Service (AMS) sought public input on 30 questions in 2017 and received more than112,000 responses. The rule asks for additional guidance as the agency looks to finalize the rule by the congressionally mandated deadline of July 29, 2018.

“Over 1,100 national, state and local organizations representing the food and agriculture value chain supported enactment of the Bioengineered Food Disclosure Act because it prevented a state-by-state patchwork of labeling laws that would have cost U.S. consumers, farmers and manufacturers billions of dollars,” according to a statement by the Coalition for Safe Affordable Food.

Related:APHIS seeks comments on biotech regulation

Multi-food products

The proposed rule lays out guidelines for multi-food products. For instance, a multi-ingredient food product that contains broth, stock, water or similar solution as the first ingredient and a meat, poultry or egg product as the second ingredient on the food label would not be subject to the labeling. As an example, a canned ham where pork is the primary ingredient, followed by other ingredients such as corn syrup, would not be subject to the NBFDS. Even though the corn syrup may be bioengineered, because the predominant ingredient is pork, which is subject to the labeling requirements of the Federal Meat Inspection Act, the product is not subject to the NBFDS, pursuant to the amended act.

If, however, a meat, poultry or egg ingredient is the third most predominant ingredient or lower, the food will be subject to the NBFDS. For example, a soup with the following ingredient list – broth, carrots, chicken, etc. – would be subject to disclosure under the NBFDS, and the analysis as to whether it would be considered a “bioengineered food” subject to the NBFDS disclosure requirements would continue.

In addition, the amended act prohibits a food derived from an animal from being considered a bioengineered food solely because the animal consumed feed produced from, containing or consisting of a bioengineered substance. For example, eggs used in a baked good, where the eggs come from chickens receiving feed produced from bioengineered corn and soybeans, would not be considered bioengineered solely on the basis of the chickens' feed.

Bioengineering definition

The amended act defines “bioengineering,” with respect to a food, as referring to a food: “(A) that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques, and (B) for which the modification could not otherwise be obtained through conventional breeding or found in nature.”

Responses to AMS’s 30 questions disclosed wide differences in public opinion about how the statutory definition of bioengineering should be interpreted and applied to the definition of “bioengineered food.” Specifically, respondents offered conflicting views on highly refined foods and ingredients and whether those products should fall within the definition, thus subjecting those foods and ingredients to disclosure.

As to specific technologies, USDA also noted that AMS recognizes that technologies continue to evolve and that food produced through a specific technology may or may not meet the definition of bioengineered food. The department noted that the proposed process for establishing and amending the bioengineered food lists would provide a vehicle by which AMS could evaluate whether a particular crop meets the definition of bioengineering.

In a separate statement, the National Grain & Feed Assn. (NGFA), a member of the Steering Committee of the Safe Affordable Food Coalition, noted its support for USDA proposing to grant a tolerance before labeling is required for inadvertent or technically unavoidable bioengineered ingredients contained in food and beverage products. NGFA noted that a 5% tolerance for biotech presence exists within USDA's National Organic Standard and with many other countries, including Indonesia, Japan, South Africa, Thailand and Vietnam. Lack of a realistic threshold for disclosure would substantially increase compliance costs, disrupt supply chains and raise food costs, NGFA said.

NGFA also commended USDA for proposing to rely upon customary and reasonable business records that traditionally are maintained as being sufficient for documenting compliance with the rule. It noted that this presumably would include contracts, purchase specifications and confirmations. Doing otherwise would create "complex, cumbersome and extremely costly" recordkeeping requirements within the supply chain that could cause companies to shun the handling or use of safe, wholesome and nutritious bioengineered ingredients in their products, NGFA said.

Comment deadline July 3

The proposed rule is open for comment for 60 days. Due to the congressionally mandated timeline for this rule-making, the comment period will not be extended, so it is important that anyone interested in filing comments do so in a timely manner, USDA said.

“Given the importance of ensuring the final rule is in place by the statutory deadline, the coalition will be analyzing the proposed rule and developing coordinated food and agricultural industry comments over the next 60 days. The coalition looks forward to providing the department with input that reflects the needs of consumers, farmers and the rest of the food value chain,” the Coalition for Safe Affordable Food noted.

Comments may be submitted online through the Federal eRulemaking portal at www.regulations.gov. Comments may also be filed with the Docket Clerk, 1400 Independence Ave. SW, Room 4543-South, Washington, DC 20250; or FAX: (202) 690-0338.

The deadline for comments is July 3, 2018.

Read the proposed rule here.