Regulation of Cell-Cultured Meat

Regulation of Cell-Cultured Meat

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Updated October 25, 2018
Regulation of Cell-Cultured Meat
Cell-cultured meat (also referred to as lab-grown meat,
risk and develop methods to mitigate the risk. FSIS
clean meat, in vitro meat, imitation meat, synthetic meat,
inspectors are in federally inspected meat and poultry
and fake meat) is grown in laboratories from animal cell-
slaughter plants during all hours of operation and in meat,
cultures (Figure 1). A number of U.S. cell-cultured meat
poultry, catfish, and egg processing plants during each shift.
companies are developing products that some believe could
During this time, inspectors are conducting food safety
be sold within three years in certain markets and widely
activities, including HACCP and sanitation checks and
available in 10 years. Both the Department of Health and
pathogen and residue testing.
Human Services’ (HHS) Food and Drug Administration
(FDA) and the U.S. Department of Agriculture (USDA)
FDA implements and enforces the Federal Food, Drug, and
have released statements claiming oversight of cell-cultured
Cosmetic Act (FFDCA; 21 U.S.C. 301 et seq.), the Food
meat (Table 1).
Safety Modernization Act (FSMA; 21 U.S.C. 2201 et seq.),
the Public Health Service Act (42 U.S.C. 201 et seq.), the
Figure 1. Cell-Cultured Meat
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.
FDA and FSIS often share overlapping responsibilities for
food products and have developed “memoranda of
FSIS and FDA Authorities
understanding” (MOU) to facilitate communication
FDA and the USDA Food Safety and Inspection Service
between the two agencies. For example, there are MOUs
(FSIS) ensure that the U.S. food supply—both domestic and
for facilities with joint jurisdiction (MOU 225-99-2001)
imported—is unadulterated, wholesome, and properly
and catfish inspection (MOU 225-14-0009).
labeled. For meat products, the FSIS regulates meat
(amenable species: cattle, hogs, sheep, goat, and equines),
Cell-Cultured Meat Debate
poultry (chicken, turkeys, ducks, geese, squab, guinea fowl,
During the first half of 2018, the livestock industry and the
and ratites), catfish, and egg products. FDA regulates game-
House Appropriations Committee addressed cell-cultured
meat, fish and seafood, processed meat products
meat, while FDA and USDA each publicly staked a claim
(containing 2%-3% of meat), and shell eggs.
to oversight of cell-cultured meat. FDA held a public
meeting in July 2018 to discuss the regulation of this new
FSIS implements and enforces the Federal Meat Inspection
technology. USDA and FDA jointly hosted a meeting in
Act (FMIA; 21 U.S.C. 601 et seq.), the Poultry Products
October 2018 to discuss potential hazards in production of
Inspection Act (21 U.S.C. 451 et seq.), and the Egg
cell-cultured meat and labeling. Both meetings were open
Products Inspection Act (EPIA; 21 U.S.C. 1031 et seq.).
for public comment. (See Table 1.)
FSIS may conduct voluntary inspections of non-amenable
species (e.g., bison) under the Agriculture Marketing Act (7
Regulating Cell-Cultured Meat Production
U.S.C. 1621 et seq.).
FDA and advocates for cell-cultured meat argue that the
agency is best prepared to regulate cell-cultured meat
FSIS inspection operates on the principles of Hazard
because of its expertise in regulating new food technologies
Analysis and Critical Control Points (HACCP), where meat
and food additives. In addition, FDA’s “generally
and poultry plants identify potential points of food safety
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 cell-
the technology—both the environmental benefits and the
cultured meat will be produced in facilities that are similar
decrease in food-borne pathogens and drug residues.” The
to food manufacturing or biologics facilities that FDA
livestock industry view the term clean meat as derogatory,
currently regulates, whereas cell-cultured production will
with the inference being that if cell-cultured meat is
not look like slaughter plants that FSIS regulates. As with
“clean,” then traditional meats would be “dirty.” This could
traditional meat production, there are risks that cell-cultured
be viewed as misleading and a violation of food labeling
meat could be contaminated during production stages.
rules. A recent Consumer Reports survey indicated that
Either the FDA risk-based approach or the FSIS HACCP
consumers would disagree with GFI and would prefer the
approach with regular inspector oversight could be viewed
“lab-grown meat” label.
as a way to mitigate risk in cell-cultured meat production.
Some stakeholders question whether cell-cultured meat is
Some critics of cell-cultured meat argue that there is not
even “meat.” The USCA petition requested that USDA
enough information available to fully evaluate cell-cultured
limit the term beef to product “born, raised, and harvested
meat production. Friends of the Earth, an environmental
in a traditional manner” and meat to mean the “tissue or
advocacy group, is concerned about oversight and the
flesh of animals that have been harvested in the traditional
safety of cell-cultured meat. In part, they raise concerns
manner.” This position would hold that cell-cultured meat
about the full disclosure of resources required to make cell-
should not be labeled “meat.” Views among the livestock
cultured meat products and the use of genetically
industry diverge somewhat. For example, the National
engineered products as ingredients.
Cattlemen’s Beef Association (NCBA) does not support the
USCA petition, although it believes the term beef applies
Table 1. Timeline of Selected Events and Statements
only to product derived from cattle. However, NBCA
believes cell-cultured meat falls under the definition of a
Date
Description
“meat product” in FMIA—“any product … made wholly or
02/09/18
The U.S. Cattlemen’s Association (USCA) submitted a
in part from any meat or other portion of the carcass” (21
petition to USDA asking FSIS to establish meat labeling
U.S.C. 601(j)). Accordingly, cell-cultured meat—derived
requirements that exclude product not derived directly
from animal cells—would fall under FSIS jurisdiction and
from animals raised and slaughtered. USDA has not
responded to the petition yet.
oversight. The position in the USCA petition could result in
FDA taking jurisdiction over cell-cultured meat.
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
Food labeling is often contentious. The dairy industry has
poultry are under the sole purview of USDA and that any
long argued that the term milk as applied to plant-based
product labeled as meat would be under USDA purview.
products (e.g., almond and soy milk) is misleading and
05/24/18
The FY2019 House Appropriations Committee–reported
violates the FDA standards of identity for milk. Legislation
USDA appropriations bil (H.R. 5961) has general provision
introduced in the 115th Congress (Dairy Pride Act; H.R. 778
language requiring USDA to regulate cell-cultured meat.
and S. 130) would limit the use of the term milk. In July
06/15/18
FDA Commissioner Gottlieb issued a statement on cell-
2018, FDA announced that it would review the labeling of
cultured meat announcing that under the FFDCA, the FDA
has oversight for cell-cultured meat. FDA also announced
plant-based “milk” and “yogurt” products.
a public meeting on cell-cultured meat.
06/15/18
In response to the FDA announcement, a USDA
Unclear Regulatory Framework
spokesman reportedly stated that USDA has the sole
In the 1980s, the White House Office of Science and
purview of meat and is open to working with FDA.
Technology Policy issued the Coordinated Framework for
07/12/18
FDA hosted a public meeting, “Foods Produced Using
the Regulation of Biotechnology to coordinate the roles of
Animal Cell Culture Technology,” where the scientific
various agencies involved in emerging biotechnology. The
community, private sector, and advocacy groups discussed
agencies subsequently developed agency-specific
several questions that FDA posed to the public.
regulations to address their oversight responsibilities.
10/23-
USDA and FDA hosted a public meeting, “The Use of Cell
24/18
Culture Technology to Develop Products Derived from
Livestock and Poultry.” USDA and FDA officials discussed
In June 2018, Politico reported that the White House
respective regulatory frameworks and how they could
Domestic Policy Council would hold a meeting between
apply to cell-cultured meat.
FDA and USDA to discuss cell-cultured meat, indicating
Source: Compiled by the Congressional Research Service.
that the Administration could move to resolve regulatory
authority issues. The Administration may need to referee
Labeling Cell-Cultured Meat Products
decisions on how production is regulated and how it is
Besides determining how the production of cell-cultured
labeled. In Congress, the House Appropriations Committee
meat will be regulated, much debate centers on what to call
has taken the position that USDA should regulate cell-
the product. Both FDA and FSIS are responsible for
cultured meat. Others may see FDA as better suited to
ensuring that food product labels are truthful and not
regulate cell-cultured meat.
misleading. The Good Food Institute (GFI), an advocacy
group for plant-based foods and cell-cultured meat, argues
Joel L. Greene, Analyst in Agricultural Policy
the cell-cultured meat products should be called “clean
Sahar Angadjivand, Analyst in Agricultural Policy
meat.” According to GFI, clean meat “is a more accurate
way of describing real meat grown without animal
IF10947
slaughter. Second, ‘clean meat’ is similar to ‘clean energy’
in that it immediately communicates important aspects of
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Regulation of Cell-Cultured Meat

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