Regulation of Cell-Cultured Meat

Updated October 25, 2018

Regulation of Cell-Cultured Meat

Cell-cultured meat (also referred to as lab-grown meat,

clean meat, in vitro meat, imitation meat, synthetic meat,

and fake meat) is grown in laboratories from animal cellcultures (Figure 1). A number of U.S. cell-cultured meat

companies are developing products that some believe could

be sold within three years in certain markets and widely

available in 10 years. Both the Department of Health and

Human Services’ (HHS) Food and Drug Administration

(FDA) and the U.S. Department of Agriculture (USDA)

have released statements claiming oversight of cell-cultured

meat (Table 1).

Figure 1. Cell-Cultured Meat

risk and develop methods to mitigate the risk. FSIS

inspectors are in federally inspected meat and poultry

slaughter plants during all hours of operation and in meat,

poultry, catfish, and egg processing plants during each shift.

During this time, inspectors are conducting food safety

activities, including HACCP and sanitation checks and

pathogen and residue testing.

FDA implements and enforces the Federal Food, Drug, and

Cosmetic Act (FFDCA; 21 U.S.C. 301 et seq.), the Food

Safety Modernization Act (FSMA; 21 U.S.C. 2201 et seq.),

the Public Health Service Act (42 U.S.C. 201 et seq.), the

Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.),

and parts of the EPIA related to shell eggs.

FDA conducts inspections of regulated facilities to

determine a firm’s compliance. FDA inspections are on a

periodic basis, and inspectors are not in facilities during all

hours of operation. FDA also inspects vehicles and other

conveyances—such as boats, trains, and airplanes—in

which foods are transported or held in interstate commerce.

FDA contracts with states to use their food safety agency

personnel to carry out certain field inspections in support of

FDA’s own statutory responsibilities. FSMA provided FDA

with new authorities focused on good manufacturing

practices and hazard analysis and risk-based preventive

controls (21 C.F.R. 117) that are designed to prevent food

safety problems. FSMA provided FDA with mandatory

recall authority and increased the frequency of the

inspection of high-risk food facilities.

Source: Maastricht University, Alberto Cuadra, Washington Post.

FSIS and FDA Authorities

FDA and the USDA Food Safety and Inspection Service

(FSIS) ensure that the U.S. food supply—both domestic and

imported—is unadulterated, wholesome, and properly

labeled. For meat products, the FSIS regulates meat

(amenable species: cattle, hogs, sheep, goat, and equines),

poultry (chicken, turkeys, ducks, geese, squab, guinea fowl,

and ratites), catfish, and egg products. FDA regulates gamemeat, fish and seafood, processed meat products

(containing 2%-3% of meat), and shell eggs.

FSIS implements and enforces the Federal Meat Inspection

Act (FMIA; 21 U.S.C. 601 et seq.), the Poultry Products

Inspection Act (21 U.S.C. 451 et seq.), and the Egg

Products Inspection Act (EPIA; 21 U.S.C. 1031 et seq.).

FSIS may conduct voluntary inspections of non-amenable

species (e.g., bison) under the Agriculture Marketing Act (7

U.S.C. 1621 et seq.).

FSIS inspection operates on the principles of Hazard

Analysis and Critical Control Points (HACCP), where meat

and poultry plants identify potential points of food safety

FDA and FSIS often share overlapping responsibilities for

food products and have developed “memoranda of

understanding” (MOU) to facilitate communication

between the two agencies. For example, there are MOUs

for facilities with joint jurisdiction (MOU 225-99-2001)

and catfish inspection (MOU 225-14-0009).

Cell-Cultured Meat Debate

During the first half of 2018, the livestock industry and the

House Appropriations Committee addressed cell-cultured

meat, while FDA and USDA each publicly staked a claim

to oversight of cell-cultured meat. FDA held a public

meeting in July 2018 to discuss the regulation of this new

technology. USDA and FDA jointly hosted a meeting in

October 2018 to discuss potential hazards in production of

cell-cultured meat and labeling. Both meetings were open

for public comment. (See Table 1.)

Regulating Cell-Cultured Meat Production

FDA and advocates for cell-cultured meat argue that the

agency is best prepared to regulate cell-cultured meat

because of its expertise in regulating new food technologies

and food additives. In addition, FDA’s “generally

recognized as safe” principles may make FDA the best

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Regulation of Cell-Cultured Meat

choice to regulate cell-cultured meat. Some argue that cellcultured meat will be produced in facilities that are similar

to food manufacturing or biologics facilities that FDA

currently regulates, whereas cell-cultured production will

not look like slaughter plants that FSIS regulates. As with

traditional meat production, there are risks that cell-cultured

meat could be contaminated during production stages.

Either the FDA risk-based approach or the FSIS HACCP

approach with regular inspector oversight could be viewed

as a way to mitigate risk in cell-cultured meat production.

Some critics of cell-cultured meat argue that there is not

enough information available to fully evaluate cell-cultured

meat production. Friends of the Earth, an environmental

advocacy group, is concerned about oversight and the

safety of cell-cultured meat. In part, they raise concerns

about the full disclosure of resources required to make cellcultured meat products and the use of genetically

engineered products as ingredients.

Table 1. Timeline of Selected Events and Statements

Date

Description

02/09/18

The U.S. Cattlemen’s Association (USCA) submitted a

petition to USDA asking FSIS to establish meat labeling

requirements that exclude product not derived directly

from animals raised and slaughtered. USDA has not

responded to the petition yet.

04/18/18

During testimony before the House Committee on

Appropriations, USDA Secretary Perdue, in response to

questions on cell-cultured meat, stated that meat and

poultry are under the sole purview of USDA and that any

product labeled as meat would be under USDA purview.

05/24/18

06/15/18

The FY2019 House Appropriations Committee–reported

USDA appropriations bill (H.R. 5961) has general provision

language requiring USDA to regulate cell-cultured meat.

FDA Commissioner Gottlieb issued a statement on cellcultured meat announcing that under the FFDCA, the FDA

has oversight for cell-cultured meat. FDA also announced

a public meeting on cell-cultured meat.

06/15/18

In response to the FDA announcement, a USDA

spokesman reportedly stated that USDA has the sole

purview of meat and is open to working with FDA.

07/12/18

FDA hosted a public meeting, “Foods Produced Using

Animal Cell Culture Technology,” where the scientific

community, private sector, and advocacy groups discussed

several questions that FDA posed to the public.

10/2324/18

USDA and FDA hosted a public meeting, “The Use of Cell

Culture Technology to Develop Products Derived from

Livestock and Poultry.” USDA and FDA officials discussed

respective regulatory frameworks and how they could

apply to cell-cultured meat.

Source: Compiled by the Congressional Research Service.

Labeling Cell-Cultured Meat Products

Besides determining how the production of cell-cultured

meat will be regulated, much debate centers on what to call

the product. Both FDA and FSIS are responsible for

ensuring that food product labels are truthful and not

misleading. The Good Food Institute (GFI), an advocacy

group for plant-based foods and cell-cultured meat, argues

the cell-cultured meat products should be called “clean

meat.” According to GFI, clean meat “is a more accurate

way of describing real meat grown without animal

slaughter. Second, ‘clean meat’ is similar to ‘clean energy’

in that it immediately communicates important aspects of

the technology—both the environmental benefits and the

decrease in food-borne pathogens and drug residues.” The

livestock industry view the term clean meat as derogatory,

with the inference being that if cell-cultured meat is

“clean,” then traditional meats would be “dirty.” This could

be viewed as misleading and a violation of food labeling

rules. A recent Consumer Reports survey indicated that

consumers would disagree with GFI and would prefer the

“lab-grown meat” label.

Some stakeholders question whether cell-cultured meat is

even “meat.” The USCA petition requested that USDA

limit the term beef to product “born, raised, and harvested

in a traditional manner” and meat to mean the “tissue or

flesh of animals that have been harvested in the traditional

manner.” This position would hold that cell-cultured meat

should not be labeled “meat.” Views among the livestock

industry diverge somewhat. For example, the National

Cattlemen’s Beef Association (NCBA) does not support the

USCA petition, although it believes the term beef applies

only to product derived from cattle. However, NBCA

believes cell-cultured meat falls under the definition of a

“meat product” in FMIA—“any product … made wholly or

in part from any meat or other portion of the carcass” (21

U.S.C. 601(j)). Accordingly, cell-cultured meat—derived

from animal cells—would fall under FSIS jurisdiction and

oversight. The position in the USCA petition could result in

FDA taking jurisdiction over cell-cultured meat.

Food labeling is often contentious. The dairy industry has

long argued that the term milk as applied to plant-based

products (e.g., almond and soy milk) is misleading and

violates the FDA standards of identity for milk. Legislation

introduced in the 115th Congress (Dairy Pride Act; H.R. 778

and S. 130) would limit the use of the term milk. In July

2018, FDA announced that it would review the labeling of

plant-based “milk” and “yogurt” products.

Unclear Regulatory Framework

In the 1980s, the White House Office of Science and

Technology Policy issued the Coordinated Framework for

the Regulation of Biotechnology to coordinate the roles of

various agencies involved in emerging biotechnology. The

agencies subsequently developed agency-specific

regulations to address their oversight responsibilities.

In June 2018, Politico reported that the White House

Domestic Policy Council would hold a meeting between

FDA and USDA to discuss cell-cultured meat, indicating

that the Administration could move to resolve regulatory

authority issues. The Administration may need to referee

decisions on how production is regulated and how it is

labeled. In Congress, the House Appropriations Committee

has taken the position that USDA should regulate cellcultured meat. Others may see FDA as better suited to

regulate cell-cultured meat.

Joel L. Greene, Analyst in Agricultural Policy

Sahar Angadjivand, Analyst in Agricultural Policy

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IF10947

Regulation of Cell-Cultured Meat

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