Opinion: Tend the Field -- Regulatory Changes on the Horizon

While all eyes in the agriculture community are on the farm bill, there is a lot of regulatory activity underway. Some of it is certain to happen; others less so. Nonetheless, it warrants attention and being alert to the possibilities that could impact you. Here are just a few key examples:

1. Bioengineered Food Labeling

On July 29, 2016, a bill that amended the Agricultural Marketing Act of 1946 to include Subtitle E, the National Bioengineered Food Disclosure Standard, was signed into law. The law charged USDA’s Agricultural Marketing Service (AMS) with developing a national, mandatory system for disclosing the presence of bioengineered (BE) material in food through labeling. The Standard is expected to increase consumer confidence and understanding of the foods they buy, and to avoid uncertainty for food companies and farmers.

To ensure consistency across AMS labeling programs, AMS issued a Policy Memorandum that specifies the criteria that AMS will use when proposing rules for mandatory BE food disclosure and labeling so as to prevent conflicts between the requirements of the USDA organic regulations and the requirements of a proposed genetically modified organism (GMO) disclosure program.

On May 4, 2018, AMS posted a 106-page proposed rule that would require food manufacturers and other entities that label foods for retail sale to disclose information about BE food and BE food ingredient content  It also has published proposed disclosure symbols.

AMS’ proposed BE Standard has been criticized for replacing terminology already familiar to consumers (e.g., “genetically-engineered,” “GMO”) with new words; for expanding labeling options to include smart phone-friendly text messages and electronic or digital link disclosures (e.g., quick response QR) codes); and for aiming to associate a smiley face and sunshine symbol with controversial technology. It also leaves important questions unanswered – in particular, whether foods produced using newer genetic engineering techniques, such as gene-editing and synthetic biology, will be subject to the BE labeling standard. Notably, the EU's Court of Justice recently ruled that organisms genetically edited through a process called “mutagenesis” (i.e., genetic information of an organism is changed, resulting in a mutation) will now be subject to the EU GMO law, previously restricted to organisms derived through “transgenesis” (i.e., insertion of DNA from one species into another).   

The statute required AMS’ BE Food Disclosure Standard to come into effect by July 29, 2018. Well, stay tuned …

2. Use of Dairy Terms To Identify Plant-Based Alternatives

In remarks delivered on March 29, 2018, before the National Food Policy Conference, FDA Commissioner Scott Gottlieb, M.D., announced a comprehensive, multi-year Nutrition Innovation Strategy, which will take a fresh look at what can be done to reduce preventable death and disease related to poor nutrition.

As one part of this initiative, FDA is assessing whether dairy names should be permitted to be used to identify plant-based alternatives: 

One area that needs greater clarity – and which has been the subject of much discussion of late – is the wide variety of plant-based foods that are being positioned in the marketplace as substitutes for standardized dairy products. Many of these plant-based foods use traditional dairy terms (e.g., milk, yogurt, cheese) in the name of the product. For instance, we’ve seen a proliferation of products made from soy, almond or rice calling themselves milk. However, these alternative products are not the food that has been standardized under the name “milk” and which has been known to the American public as “milk” long before the 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act) was established. In addition, some of these products can vary widely in their nutritional content – for instance in relation to inherent protein or in added vitamin content – when compared to traditional milk.

Remarks by Dr. Gottlieb at the Public Meeting on FDA's Comprehensive, Multi-Year Nutrition Innovation Strategy (July 26, 2018). Just one month earlier, FDA Commissioner Gottlieb had stated: [W]e need to more closely examine whether certain almond- or soy-derived products should be able to call themselves milk. Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to advance health through improvements in nutrition under the agency’s Nutrition Innovation Strategy (June 26, 2018).

Over the next year or so, FDA should be expected to collect and analyze information relating to the propriety of dairy-like names – such as “almond-milk” and “rice milk” – being used on milk substitutes. The issue will be whether such names are false or misleading, including whether the substitute plant-based beverages are nutritionally equivalent to standardized milk.

At the same time, Senator Tammy Baldwin (D-WI) has introduced Senate Bill 130, the “Dairy Pride” Act. The bill would protect the integrity of dairy products by amending the FD&C Act’s misbranding provisions. It would require that nondairy products made from nuts, seeds, plants, and algae no longer be confusingly labeled with dairy terms like “milk,” “yogurt,” and “cheese.”  An identical, companion bill, H.R.778, has been entered in the House of Representatives.

One way or the other, this issue reasonably may be anticipated to be resolved over the next few years.

3. Food Safety Jurisdiction

President Trump issued Executive Order (EO) 13781, the “Comprehensive Plan for Reorganizing the Executive Branch,” on March 13, 2017. In the interim, pursuant to the EO’s directive, OMB has collected a proposed reorganization plan to improve efficiency and accountability from each federal agency. On June 21^st, 2018, it published Delivering Government Solutions in the 21st Century: Reform Plan and Reorganization Recommendations, which included a section entitled “Reorganize Primary Federal Food Safety Functions into a Single Agency, the Federal Food Safety Agency.”

This proposal is intended to address the admittedly fragmented, federal oversight of food safety by reorganizing FSIS and the food safety functions of FDA into a single agency within USDA. FDA would be renamed the “Federal Drug Administration” and would administratively focus on drugs, devices, biologics, tobacco, dietary supplements, and cosmetics.

Consensus has been evolving for years about the need to consolidate federal food safety functions. Nevertheless, Congressional committees remain reluctant to alter their purviews and, this being the case, effectuation of this proposal seems unlikely.

4. Prop 65

Changes to the recommended Prop 65 warnings for consumer products came into effect on August 31, 2018.

In September of 2017, the California Office of Environmental Health Hazard Assessment (OEHHA) adopted amendments to Prop 65. The amendments updated the requirements for Prop 65 chemical warning labels, redefining the criteria for what constitutes a “clear and reasonable” warning. A current Prop 65 warning typically states: “WARNING: This product contains a chemical known to the State of California to cause cancer.”  A sample new “safe harbor” warning would be: “WARNING: This product can expose you to chemicals including arsenic, which is known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.”  [Note: The new warning would be preceded by a yellow triangle with an exclamation mark centered within it.]

The new warning notably includes:

• The name of at least one listed chemical that prompted the warning;
• The Internet address for OEHHA’s new Proposition 65 warnings website, www.P65Warnings.ca.gov, which includes additional information on the health effects of listed chemicals and ways to reduce or eliminate exposure to them; and
• A triangular yellow warning symbol on most warnings.

The new warning regulation also:

• Adds new “tailored” warnings that provide more specific information for certain kinds of exposures, products, and places;
• Provides for website warnings for products purchased over the Internet;
• Provides for warnings in languages other than English in some cases; and
• Clarifies the roles and responsibilities of manufacturers and retailers in providing warnings.

            The new warning system has several main goals. These include:

• Making warnings more meaningful and useful for the public;
• Reducing “over-warning” in which businesses provide unnecessary warnings; and
• Giving businesses clearer guidelines on how and where to provide warnings.

About the authors: Michael O’Flaherty is a partner at OFW Law and is the author of “U.S. Food Labeling Guide,” as well as many articles on the subject. Marshall Matz specializes in agriculture at OFW Law.