By Kindra Gordon

 “Alternative proteins are a topic I’m talking about more and more,” said Mark Dopp as he presented remarks this past February in Phoenix, Ariz. during the 2018 Cattle Industry Convention. 

Dopp, who is general counsel and senior vice president of regulatory and scientific affairs for the North American Meat Institute, explained the reason this topic is garnering attention is because the regulatory process for animal based (lab grown) proteins coming into the marketplace is yet to be determined. While there are currently no animal based proteins (sometimes referred to as fake meat) on the market, they could be available by the end of the year, Dopp speculates.

At issue is which agency will have regulatory jurisdiction – will it be the Food Safety and Inspection Service (FSIS) or the Food and Drug Administration (FDA)? Dopp notes that plant based proteins – like Boca burgers – are regulated by FDA under the Food, Drug and Cosmetic Act. While the Federal Meat Inspection Act gives primary jurisdiction regarding meat and poultry to FSIS. 

One key difference between the two agencies, according to Dopp, is that FSIS regulated products must gain label approval from the USDA Secretary. While there is no label approval required of FDA regulated products, but the Federal Trade Commission does have jurisdiction over advertising claims for these products.

Thus, in determining which agency will oversee animal based alternative proteins the question to be answered: Are alternative animal based proteins considered meat?

Dopp shared that one statute dating back to 1906 defines meat as “part of the muscle…which is skeletal or which is found in the tongue, diaphragm, heart or esophagus.” But that definition does not align with what is in current federal code, which means today’s administration will need to decide which agency will regulate the animal based protein products.

Dopp does however believe lab-grown or lab-cultured animal based proteins should fit in the meat by-product or meat food product definition as it is currently defined in the statute. (Presently, meat by-products include items like pepperoni and luncheon meats) Thus he says, “This gives guidance of who should have jurisdiction over these products if and when they enter commerce…it should be FSIS.” But he added, “Do I know that’s going to be the case? No.”

NCBA’s stance

On April 10, 2018, the National Cattlemen’s Beef Association submitted official comments to USDA outlining key principles for the regulation of fake meat products. The comments, filed in response to Food Safety Inspection Service (FSIS) Petition Number 18-01, encourage USDA to look beyond modifying “standards of identity” in order to provide adequate protection for beef producers and consumers. 

“It is critical that the federal government step up to the plate and enforce fair and accurate labeling for fake meat,” said Kevin Kester, President of NCBA. “As long as we have a level playing field, our product will continue to be a leading protein choice for families in the United States and around the world.”

NCBA’s regulatory principles are designed to effectively address both plant-based and lab-grown imitation beef products. Specifically, NCBA:

1) Requests that USDA work with the Food and Drug Administration (FDA) to “take appropriate, immediate enforcement action against improperly-labeled imitation products.” NCBA firmly believes the term beef should only be applicable to products derived from actual livestock raised by farmers and ranchers. For misbranded and mislabeled plant-based protein products, existing legislation gives FDA the authority to take enforcement actions. However, the agency has previously failed to take an enforcement role. Thus, NCBA requests USDA engage with FDA to facilitate immediate, appropriate enforcement actions against imitation meat product labels that clearly violate existing laws.

2) Urges USDA to “assert jurisdiction over foods consisting of, isolated from or produced from cell culture or tissue culture derived from livestock and poultry animals or their parts.”  NCBA believes that USDA-FSIS is the agency best placed to regulate emerging lab-grown meat products. First, USDA-FSIS possesses the technical expertise and regulatory infrastructure to ensure perishable meat food products are safe for U.S. consumers. Lab-grown meat must comply with the same stringent food safety inspection standards as all other meat products.

Second, USDA-FSIS labeling standards provided greater protection against false and misleading marketing claims. Unlike the FDA, USDA-FSIS requires pre-approval of all labels before products hit the marketplace. This will ensure consistent labeling practices across all products, and prevent misleading marketing labels such as “clean meat.” 

Additional Insight

If FSIS were given regulatory oversight of animal based alternative proteins, Dopp says several key questions will need to be addressed:

• Will the cells used have to come from an animal that passed ante-mortem inspection?

• Will the plant manufacturing the alternative animal based protein product need a Hazard Analysis Critical Control Point (HACCP) plan, a Sanitation Standard Operating Procedure (SSOP), and federal inspection as is required of other animal food processing facilities?

• What type of sampling regimen, if any, is appropriate?

• For labeling, will there be some kind of disclosure on the label?

• What about use of the term “clean meat,” will that be allowed?

Dopp underscored that these issues will need to be evaluated to ensure fairness of new products with existing products in the marketplace. Regarding the term “clean meat,” he added, “I’m pretty confident that term is not going to be permissible because it calls into question the integrity of the market – suggesting everything else is dirty.”

Dopp says additional issues raised by the alternative protein production process include recognizing the environmental impact isn’t necessarily lessened because a slaughter facility is being traded for a large manufacturing laboratory. As well, if alternative proteins displace meat production and consumption, there will be ramifications to other products including leather, pet foods, pharmaceuticals, cosmetics and other co-products.

On the other side of the coin, if animal based alternative proteins are put under FDA jurisdiction Dopp says it will likely be a quicker process to get them into the marketplace. However, he adds they will not be able to be referred to in any way as meat. He points out, “If it’s meat then how does it not end up under FSIS and USDA?”

Another question to consider under FDA jurisdiction, might the lab grown product be considered “bioengineered” under the GMO law?

Whatever happens, Dopp says the critical point is this, “We need to make sure the playing field [of regulations] is level for everybody.”