Food Safety: FDA and USDA Could Strengthen Existing Efforts to Prepare for Oversight of Cell-Cultured Meat

Multiple firms have produced cell-cultured meat as part of their research and development. These products appear likely to become available to consumers in coming years. FDA and USDA are the primary agencies responsible for overseeing the safety of the nation's food supply. However, some stakeholders have expressed concern about the agencies' oversight of cell-cultured meat amidst a fragmented federal food safety oversight system.

GAO was asked to review federal oversight of cell-cultured meat. This report (1) describes what is known about methods for commercially producing cell-cultured meat, and (2) examines the extent to which FDA and USDA are collaborating to provide regulatory oversight of cell-cultured meat. GAO conducted a literature review; reviewed documentation from FDA, USDA, and stakeholder groups; analyzed public comments submitted to the agencies; compared agency efforts with leading practices for interagency collaboration; and conducted site visits to selected cell-cultured meat firms.

General information about the process of making cell-cultured meat—food products grown from the cells of livestock, poultry, and seafood—is available. However, no company is commercially producing cell-cultured meat. Specific information about the technology being used, eventual commercial production methods, and composition of the final products is not yet known. The general process contains five phases: biopsy, cell banking, growth, harvest, and food processing (see figure). The technology and methods to be used for commercial production are still in development, and producers, regulators, and consumers do not have clarity about many specifics about the process and final product. For example, it is unclear whether production methods and products will use or contain genetically-engineered cells or medications such as antibiotics.

The Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) have begun collaborating on regulatory oversight of cell-cultured meat. For example, in 2019, the agencies signed an interagency agreement and created three working groups to carry out the terms of the agreement. However, the agreement and working groups could more fully incorporate practices to enhance and sustain collaboration, such as defining outcomes. For example, the agreement identifies the development of labeling principles as an outcome, but does not describe how the agencies will track and monitor progress toward this outcome, and the working groups identify a lead agency but not members' roles. Also, agency officials said they decided FDA would oversee cell-cultured seafood other than catfish, but they have not formally announced or documented this decision. Developing and updating written guidance and agreements is also a leading practice for interagency collaboration. By fully incorporating leading practices into their efforts to collaborate, the agencies could minimize potential overlap and fragmentation, use resources in a more efficient manner, and better ensure the public and other key stakeholders have clarity about the agencies' oversight responsibilities.

GAO recommends that FDA and USDA more fully incorporate leading practices for effective collaboration in the agencies' interagency agreement. FDA and USDA partially concurred and indicated a willingness to incorporate these practices in a more detailed agreement, which would also meet the intent of the recommendations. The agencies concurred with the four other recommendations.

Multiple firms have produced cell-cultured meat—food products grown  from the cells of livestock, poultry, and seafood—as part of their research  and development. Although the companies are not yet selling cell- cultured meat, some firms report that their products are likely to become  available to consumers in coming years. Furthermore, in 2017, the  National Academy of Sciences identified cell-cultured meat as a  biotechnology product that has high growth potential. Cell-cultured meat  forms a part of the emerging field of cellular agriculture, which seeks to  produce conventional agricultural products from cell cultures. Livestock  and poultry account for over half of U.S. agricultural cash sales, often  exceeding $100 billion per year. However, the potential introduction of  cell-cultured meat into the nation’s food supply has raised questions  about its safety. Likewise, claims that it can be produced with less impact  on the environment than conventional meat and that it may offer health  and animal welfare benefits have also been questioned.

The Department of Health and Human Services’ (HHS) Food and Drug  Administration (FDA) and the U.S. Department of Agriculture (USDA) are  the federal agencies with primary responsibility for the oversight of food  safety. USDA is responsible for regulating the safety of meat, poultry,  processed egg products, and catfish. FDA is responsible for regulating  the safety of virtually all other food, including most seafood. In addition,  FDA is also responsible for regulating safety issues associated with  animal cell culture technology in therapeutic settings, such as growing  organs.

In advance of a July 2018 public meeting on foods produced using animal  cell culture technology, FDA indicated it expected to be involved in  regulating cell-cultured meat based on the agency’s existing statutory  authority and expertise in animal cell culturing. FDA and USDA jointly  hosted a public meeting in October 2018 to discuss the potential hazards,  oversight considerations, and labeling of cell-cultured food products  derived from livestock and poultry tissue. In November 2018, FDA and  USDA announced that they planned to jointly oversee the production of  cell-cultured meat derived from livestock and poultry, with FDA  overseeing cell collection and growth and USDA overseeing the later  stages of production and labeling. The agencies explained that they  believed this oversight model would leverage both FDA’s experience regulating cell culture technology and USDA’s expertise in regulating  livestock and poultry products for human consumption. Because of  potential risks to public health and safety, we added federal oversight of  food safety to our High Risk List in 2007, where it remains today.

You asked us to review federal oversight of cell-cultured meat. This report  (1) describes what is known about methods for commercially producing  cell-cultured meat and (2) examines the extent to which FDA and USDA  are collaborating to provide regulatory oversight of cell-cultured meat.

To address these objectives, we conducted a literature review of journal  and media articles from 2016 through 2019 to inform our understanding of  cell-cultured meat as well as regulatory activity in the United States and in  other countries. We also reviewed documents collected from FDA and  USDA, such as their 2019 interagency agreement, as well as documents  collected from cell-cultured meat firms and consumer safety groups,  among others. In addition, we attended FDA and USDA’s October 2018  public meeting and four conferences in 2019 that included content  pertaining to food safety or cell-cultured meat. We also conducted site  visits to two conventional meat-processing facilities in Georgia, three cell- cultured meat firms in California, an academic cell-culturing laboratory in  California, and a medical cell-culturing facility in Maryland. We identified  facilities and laboratories to visit through online research and the  assistance of agency officials and stakeholders.

We interviewed officials from FDA and USDA and representatives from  the cell-cultured meat and conventional meat industries, academia, food  and consumer safety groups, and state and tribal public health  associations, among others. We identified stakeholders to interview  through consultation with agency officials and other stakeholders and  through our review of literature and online sources. We sought to include  different types of stakeholders in order to understand the range of  perspectives on producing cell-cultured meat and FDA and USDA  collaboration.

For the purposes of our report, we define cell-cultured meat as food  derived from animal cells grown in an environment outside the animal.  We define cell-cultured seafood as a subcategory of cell-cultured meat.  When referencing conventional meat, we are referring to food produced  from the traditional method of slaughtering an animal, such as a cow,  hog, chicken, or fish. When referencing seafood, we are referring to  shellfish, sea fish, and freshwater fish served as food.

To describe what is known about the commercial production methods for  cell-cultured meat, in addition to the steps described above, we reviewed  two sets of public comments submitted to FDA and USDA in 2018.

To examine the extent to which FDA and USDA are collaborating to  provide regulatory oversight of cell-cultured meat, we identified efforts the  two agencies took to collaborate in this area from July 2018 through April  2020 by reviewing agency documentation and public announcements and  interviewing federal officials. We then compared these efforts with the  seven leading practices for interagency collaboration. In this report and  in our past work, we define collaboration as any joint activity that is  intended to produce more public value than could be produced when  organizations act alone. We use the terms “coordination” and  “collaboration” interchangeably. We also compared the agencies’ efforts  against standards for internal control in the federal government.

Appendix 1 presents additional information on our scope and  methodology.

We conducted this performance audit from October 2018 to April 2020 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.

In our prior work, we have found that technological innovation involves  not only creating new ideas but also translating those ideas into a new  product or service. Innovation, and the research driving it, is inherently  risky because the likelihood that research can be translated into a product  or service and the ultimate value of that product or service are unknown.  The Department of Commerce’s National Institute of Standards and  Technology describes the path from innovation to commercialization as  comprised of three overarching stages: inventing, transitioning to making,  and selling. (See fig. 1 for a description of the path from innovation to  commercialization.)

Federal Agencies’ Oversight of the Food Supply

FDA and USDA have responsibility for overseeing the safety of the food  supply. In general, FDA is responsible for ensuring the safety of virtually  all domestic and imported food products except those regulated by  USDA. USDA is responsible for ensuring the safety of meat, poultry,  processed egg products, and catfish. FDA and USDA cooperate with  states, tribes, and local food safety and public health agencies to carry  out their federal responsibilities. FDA and USDA carry out their  responsibilities in part through inspections of facilities where food is  produced. The frequency of inspections the agencies conduct varies, as  follows:

FDA. FDA’s authority requires a risk-based approach, in which  inspection rates vary depending on the level of risk associated with a  food product. FDA conducts risk-based inspections of high-risk and  non-high-risk food facilities. For example, the FDA Food Safety  Modernization Act, signed into law in 2011, specified that FDA had to  inspect all high-risk domestic facilities at least every 3 years.

USDA. Depending on the type of facility, USDA conducts inspections  at least once per operating shift or maintains a constant presence.  Specifically, USDA conducts carcass-by-carcass inspection at all  federally inspected meat and poultry slaughter facilities and verifies  that these establishments follow all food safety and humane handling  requirements. At facilities that process meat and poultry products,  USDA conducts inspections at least once per production shift,  following the agency’s longstanding interpretation of its statutes  requiring it to do so.

Among other things, the Federal Food, Drug, and Cosmetic Act requires  that food additives be approved by FDA before they can be lawfully used  in foods. Substances added to food are considered unsafe unless the  agency establishes that the use of the food additive, under specific  conditions for use, will be safe, or unless the substance is generally  recognized as safe (GRAS) under the conditions of its intended use among qualified experts. As we reported in 2010, the Federal Food, Drug,  and Cosmetic Act exempts GRAS substances from the act’s general  requirement that companies obtain FDA approval before marketing food  containing a new additive. GRAS substances include hundreds of  spices and artificial flavors, emulsifiers and binders, vitamins and  minerals, and preservatives that manufacturers add to enhance a food’s  taste, texture, nutritional content, or shelf life. The GRAS exemption  allows companies, without notice to or approval from FDA, to determine  whether there is enough support to claim a substance is GRAS. For a  company to claim a substance is GRAS, it must conclude that there is  common knowledge about the safety of the substance among experts  qualified by scientific training and experience to evaluate its safety.

In addition, as part of their oversight of the food supply, FDA and USDA  oversee food labeling of the products under their respective jurisdictions.  USDA, by statute, is charged with assuring that products under its  jurisdiction, including meat, poultry, and catfish, in interstate or foreign  commerce are properly marked, labeled, and packaged. USDA develops  and applies the labeling requirements for these products, and food  manufacturers are responsible for complying with the USDA labeling rules  and adhering to the process maintained by USDA for the evaluation and  approval of these product labels. Consistent with its statutes, USDA  requires preapproval of all labels before manufacturers can market their  products. The Federal Food, Drug, and Cosmetic Act prohibits the  misbranding of food, which includes food labeling that is false or  misleading. Consistent with its statutes, FDA ensures that foods within its  jurisdiction are not misbranded by focusing on the labels of products  already in the market. FDA establishes regulations for the enforcement of  these provisions and issues guidance. Food manufacturers are  responsible for compliance with misbranding provisions in the Federal  Food, Drug, and Cosmetic Act and its implementing regulations.

From time to time, new technologies, such as those used to make cell- cultured meat, generate challenges for FDA’s and USDA’s regulatory  structure. Other examples of new food technologies to which federal  agencies have needed to adapt include the genetic modification of plants  and irradiation of foods. In the case of genetically modified plants, there  are no specific regulations addressing products resulting from the  manipulation of the genetic material of living seeds. However, under FDA  policy, new genetically engineered crop varieties are treated like other  foods (including their conventional counterparts) under the Federal Food  Drug and Cosmetic Act and may not contain either unapproved food  additives or contaminants that would adulterate the food. In 1995, FDA  established a voluntary pre-market consultation process through which  companies are encouraged to notify the agency before marketing a food  produced from a genetically modified crop and voluntarily submit a  summary of the developer-performed safety assessment. FDA evaluates  the safety assessment for any issues that need to be addressed and  works with the developer to resolve those issues. In the case of  irradiated foods, companies seeking approval for a source of radiation  used to treat a food may submit a food additive petition to FDA  demonstrating the safety of the proposed use. FDA grants approval only  after agency scientists have determined that the proposed use is safe,  then the process can be employed commercially.

Specific Information about Cell-Cultured Meat Technology, Commercial Production Methods, and Final Product Composition Is Not Yet Known

General information about the process of making cell-cultured meat is  available, but specific information about the technology being used and  the eventual commercial production methods as well as the final products  is not yet known. While firms may vary in how they make cell-cultured  meat, the general process they use can be described in five phases.  However, the technology and methods to commercially produce cell- cultured meat are still in development, and producers, regulators, and  consumers do not yet have clarity on what these will entail. The  composition of the final product is also not yet known.

The General Process for Making Cell-Cultured Meat Contains Five Phases

The general process for making cell-cultured meat contains five phases:  biopsy, cell banking, growth, harvest, and food processing. (See fig. 2.)

The five-phase process is generally as follows:  1.  Biopsy. A biopsy is taken by collecting rice-sized tissue samples from  an animal, such as livestock, chicken, or fish. During this and  subsequent phases, specific laboratory sanitation procedures are  followed, and antibiotics may be used in order to avoid or minimize  contamination from bacteria.

Growth Media  According to researchers and representatives  from cell-cultured meat firms, the growth  media for cell-cultured meat often contains  fetal bovine serum, which is obtained from  blood drawn from a bovine fetus at slaughter.  However, researchers and representatives  from cell-culturing firms we spoke with said  they are working to develop growth media that  do not contain fetal bovine serum.  Representatives from some of these firms  also told us that the composition of the growth  media, including the exact ingredients and  their proportions, can vary based on the  specific needs of the cells and the variety of  serum used. For example, cell-cultured  seafood may have different growth media and  environmental requirements than cell-cultured  livestock and poultry.

2.  Cell banking. Biopsied cells with the most desirable traits are  selected and either used immediately for cell growth or frozen to  create a cell bank for later use. These desirable traits can be  obtained by either selecting existing cells or using genetic engineering  methods to insert, delete, or edit the DNA to target desired traits in  cells. Examples of desirable traits may include cells that divide  quickly, cells that divide a greater number of times, cells that result in  a reduced cholesterol or fat content or other desirable nutritional traits,  or cells that are more resilient to environmental factors, such as  temperature, than other cells. According to agency officials and  representatives from cell-cultured meat firms, this phase represents  an important opportunity to ensure that the source cells used to  initiate commercial production are free of pathogens or other  contaminants.   3.  Growth. During the cell growth phase, cells are placed in a bioreactor  and begin to divide and differentiate. A bioreactor is a container that  creates an environment that can sustain the growth of cells and  includes the ability to control factors such as temperature, pH, and  oxygen and carbon dioxide concentrations. Bioreactors can vary in  size, including microwave-sized and refrigerator-sized units, but could  be as large as 20 to 30 feet tall in commercial production. Bioreactors  contain a growth medium, which may include ingredients such as  glucose, amino acids, hormones and other growth factors, and other  basic nutrients that cells need to consume in order to thrive. In  addition to the medium needed for growth, the cells may need to be  attached to a structure, referred to as a scaffold, to properly develop  into cell-cultured meat.   4.  Harvest. Once the cells have divided to form a sufficiently large  amount of cell-cultured meat, producers remove—or harvest—it from  the growth medium and bioreactor. If a scaffold was used to provide a  structure for cells to grow on, then the cell-cultured meat would either  be separated from the scaffold during harvesting or left attached to an  edible scaffold.   5.  Food processing. The harvested cell-cultured meat is then prepared  into a product such as meatballs or chicken nuggets. In the future,  products similar to intact cuts of meat such as steak or chicken breast  may be produced.

The Technology to Commercially Produce Cell-Cultured Meat Is in Development, and the Eventual Commercial Production Methods and Aspects of a Final Product Are Not Yet Known

The technology to produce cell-cultured meat at a commercial scale is still  in development, and information about the methods to be used for  commercial production and the composition of the final product are not  yet known. In the continuum of moving a technology from innovation to  commercialization, cell-cultured meat firms are in the middle stage of  building and testing their prototypes, based on our discussions with  representatives from these firms. Consequently, they have not finalized  aspects of the technology and eventual commercial production methods  to be used or the composition of the final product. As a result, certain  information is not yet available to stakeholders—including cell-cultured  meat firms themselves, regulators, and the public—about specific aspects  of the technology and commercial production methods that will be used,  such as the composition of the growth medium and of the final products.

In addition to technology development, the scarcity of publicly available  research on cell-cultured meat production limits information available to  agency officials and the public. Each cell-cultured meat firm is developing  detailed information on its own eventual commercial production methods for making cell-cultured meat. However, the firms, similar to other  technology start-ups, are reluctant to disclose intellectual property and  business-sensitive information due to concerns about competition. For  example, one firm told us that they can reverse engineer parts of another  company’s commercial production method by seeing pictures of the  equipment the other company is using. In addition, cell-cultured meat  firms compete with other firms for funding from sources such as venture  capitalists, foreign governments, and conventional meat companies.

This competition for funding contributes to firms being reluctant to share  information they consider important intellectual property, such as parts of  their production processes. As a result, agency officials and other  stakeholders told us that they must largely rely on whatever information  the cell-cultured meat firms are willing to provide to understand details of  the companies’ prototype processes and products. This limitation can  affect agencies’ ability to make regulatory and other decisions.  Specifically, FDA and USDA officials said they have limited information on  cell-cultured meat production methods and products and need more in  order to regulate this new food. One USDA official explained that the  agency cannot establish labeling requirements if the agency does not  know the nutritional profile of the final product. For example, if the  scaffold on which the cell-cultured meat is grown is not edible, the  agencies may require firms to disclose certain aspects of their  commercial production methods, such as how they removed the cell- cultured meat from the scaffold. However, if the scaffold is edible, it will  affect the final composition of the product, which may require different  labeling than a product that was developed without edible scaffolding.

This lack of information results in unanswered questions about cell- cultured meat as it relates to the eventual technology and commercial  production methods to be used and the composition of the final products.  Among other things, this lack of information creates challenges for  industry and federal regulatory agencies as cell-cultured meat nears  commercialization. The sources we reviewed and stakeholders we talked  to identified a number of open questions, including the following:

Tissue collection. How often will producers need to collect biopsy  samples from animals, and what animals will be used? Some  stakeholders have stated concerns about whether, and how,  regulators will ensure that biopsies are collected from healthy animals.  For example, one cell-cultured meat firm stated that tissue samples  would be taken from slaughtered donor animals that met federal  standards for conventional processing at the time of slaughter.  However, USDA and FDA have not indicated whether they would  require cell-cultured meat firms to do so. Additionally, representatives  from cell-cultured meat firms stated that they did not yet know how  frequently they would need to collect biopsies from animals for  commercial-level production. Additionally, according to researchers,  there are too many unknowns to accurately estimate how much cell- cultured meat could be produced from a single biopsy of animal  tissue.

Genetic engineering. Will commercial production methods involve  genetic engineering? Some stakeholders expressed concern that the  use of genetic engineering in cell-cultured meat production could  cause the product to experience a lengthy wait for regulatory  approval, similar to that for genetically engineered salmon, which took  approximately 20 years. One representative from a cell-cultured meat  firm noted that uncertainty about pending government regulations  could negatively affect firms’ ability to attract and retain investors.  Representatives from some firms said understanding what regulatory  requirements will look like might influence which scientific pathways  they pursue as they continue to develop their commercial production  methods. According to FDA officials and representatives from one  cell-cultured meat firm, it is likely that some firms will use genetic  engineering in their commercial cell-cultured meat production  methods. However, representatives from two other cell-cultured meat  firms told us they were undecided as to whether they would use  genetic engineering in their commercial production methods.

Antibiotics. Will antibiotics be used to make cell-cultured meat, and  will residues be present in the final product? According to agency  officials, the presence of antibiotics in commercial production and the  potential for residues in the resulting product would represent a  significant potential concern for food safety and public health. Officials  stated that they would not expect antibiotics to be used past the cell- banking phase. Representatives from cell-cultured meat firms we  spoke to differed on whether they planned to use antibiotics in their  commercial production process, but they had not finalized their  decisions. According to one firm, if antibiotics are used, the use would  be limited both in quantity and duration.

Growth medium. What type of growth medium will producers use,  and how might variations in the media affect the final product?  According to agency officials and other stakeholders, the ingredients  used in the growth medium could affect the end product’s composition  and raise potential safety concerns. For example, FDA officials stated  that residual growth factors, such as hormones, in the final product  would be something they would likely evaluate in premarket  consultations. However, representatives from cell-cultured meat firms  stated that their firms have not finalized the medium they plan to use.  In addition, the formulation of the medium firms use could be an  important piece of intellectual property or confidential business  information.

Scaffold. What type of scaffold will producers use, if any, and will it  be edible or inedible? The use of edible or food-grade scaffolds,  where they are used, will affect the composition of the product and  may need to be evaluated by federal agencies for safety. According to  USDA officials, the composition of edible scaffolding may also create  labeling and jurisdictional concerns. For example, USDA officials  stated that the addition of edible scaffolding may require significant  additional aspects of production to be subject to USDA jurisdiction.  Additionally, researchers have commented that a chemical separation  technique needed to separate some inedible scaffolds may also need  to be evaluated for potential safety concerns.

Point of harvest. How will FDA and USDA define the point of  harvest? The point of harvest is the point at which FDA will transfer  oversight responsibilities, including inspections, to USDA.  Stakeholders have raised concerns that not having a clear definition  of the point of harvest could lead to challenges such as overlapping  inspection requirements or a gap in inspection. Representatives from  several cell-cultured meat firms we spoke to in the spring of 2019 said  it was ambiguous how FDA and USDA intended to define the point of  harvest. These representatives also said it is unclear how often each  agency plans to conduct inspections during the phases for which it is  responsible. Agency officials stated that they are working to develop  a detailed process for the transfer of jurisdiction, including defining the  point of harvest.

Scaling up production. How will firms scale up production to  commercial levels? One 2018 study conducted by researchers in the  United Kingdom stated that to produce one pound of cell-cultured  meat, firms would need bioreactors at least 2 1/2 times larger than  what is currently available. Similarly, a senior FDA official stated that  the capacity of existing production equipment is a challenge for firms  seeking to produce cell-cultured meat products at a commercial scale.  As a result, the firms themselves may have to develop the equipment  or custom order such equipment. Representatives from one cell- cultured meat firm told us that they are interacting with equipment  providers to identify commercial-scale production equipment.

Production cost. How will firms sell their product at a price point that  is both profitable to the firms and affordable to the consumer? Some  studies and stakeholders we interviewed, including representatives  from cell-cultured meat firms, said that the high production cost of cell- cultured meat is a key industry challenge. For example, in the last two  years, one firm reported that it cost $600 to make a cell-cultured meat  hamburger patty and reported that it cost about $1,200 to produce a  single cell-cultured meatball. One of the biggest cost drivers in the  production of cell-cultured meat is the growth medium, according to  some studies and some cell-cultured meat firms. To address issues of  cost and scale, some firms may develop their own, less expensive  growth media.

Safety considerations. Are potential safety hazards in commercial  production methods for cell-cultured meat different from those for  conventional meat, and how will eventual commercial production  methods affect the overall safety of the product? According to agency  officials, cell-cultured meat may present different safety challenges  compared to conventional meat. For example, according to agency  officials, residues and constituents in harvested cell-cultured meat  would be expected to be different from those in conventional meat,  depending on the details of the production process. Representatives  from one cell-cultured meat firm told us that they likely will use food  processing techniques similar to those used for conventional meat,  abide by similar health and safety standards, and possibly share food  processing facilities. However, because specific information about  commercial production methods and final products is not yet known, it  is unclear whether cell-cultured meat produced on a commercial scale  will pose any hazards not present in conventional meat.

Product composition. What will be the composition of any eventual  products? Agency officials told us that without knowing the  composition of a cell-cultured meat product, it is impossible to predict  how food safety and labeling requirements will apply. According to  representatives from some cell-cultured meat firms, initial cell-cultured  meat products most likely will not be composed entirely of cell- cultured meat but, rather, a mixture of cell-cultured meat and other  ingredients such as binding, flavoring ingredients, and plant-based  materials used in conventional food products. Some firms have  developed prototypes of cell-cultured meat products as part of their  research and development. In April 2019, representatives from one  firm told us that their prototype included about 90 percent plant-based  ingredients and 10 percent cell-cultured meat. However,  representatives from cell-cultured meat firms stated that they aim to  produce products that contain more cell-cultured meat than other  ingredients. For example, some cell-cultured meat firms have stated  that a long-term goal is to commercially produce cell-cultured meat  products that are similar to intact cuts of meat, such as steaks. As of  December 2019, these firms had not provided regulators with specific  information detailing the composition of their cell-cultured meat  prototypes, according to FDA and USDA officials.

Environmental, animal welfare, and health impacts. How will cell- cultured meat impact the environment, animal welfare, or human  health, if at all? Cell-cultured meat firms and researchers have made  various claims about the potential environmental, animal welfare, and  health advantages of cell-cultured meat over conventionally produced  meat. For example, some cell-cultured meat firms have claimed that  cell-cultured meat production would use less water and emit less  greenhouse gases than conventional meat production. Some cell- cultured meat firms have also claimed that cell-cultured meat will  improve animal welfare because slaughter will be unnecessary.  Additionally, some stakeholders stated that because there is less  opportunity for contamination from animal feces—a potential source of  contamination for conventional meat—cell-cultured meat would be  less likely than conventional meat to contain foodborne pathogens.  However, there are disagreements regarding the accuracy of these  claims. Stakeholders told us that until commercial production methods  and final products are established, these claims about impacts on the  environment, animal welfare, and human health will remain  unsubstantiated.

Timeline to market. When will cell-cultured meat products reach  consumers? As of December 2019, no cell-cultured meat products  were available for retail sale in the United States. Stakeholders give  varying estimates for when cell-cultured meat may be commercially  available. Some estimates suggest that firms may be able to  commercially produce some form of cell-cultured meat product as  soon as 2020, while others estimate that such products may not be  available for 2 to 4 years.

Labeling. How will cell-cultured meat be labeled? Labeling was an  area of concern for representatives from both conventional and cell- cultured meat firms who explained that the specific terminology, such  as “clean meat” or “lab-grown meat,” can sometimes reflect bias for,  or against, certain products, potentially affecting consumer  acceptance of these products. Additionally, stakeholders, as well as  agency officials, have emphasized the importance of labeling to  ensure consumers have accurate information about what they are  buying. For example, in February 2018 the United States Cattlemen’s  Association submitted a petition to USDA requesting that the agency  limit the term “beef” to products “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.” USDA received  over 6,000 comments on the petition, and the agency had not  responded to the petition as of December 2019. However, according  to agency officials, USDA has committed to a public process, likely  rulemaking, for the development of labeling requirements for cell- cultured meat and poultry. In addition, in recent years, a number of  states have passed laws that could affect the labeling of cell-cultured  meat when it comes to market. For example, in 2018, Missouri  enacted a law to prohibit plant-based products and cell-cultured meat  from being labeled as “meat.”

Consumer Acceptance How will consumers respond to cell-cultured  meat? It remains unclear whether consumers will embrace and  purchase cell-cultured meat products. Stakeholders we interviewed  and studies we reviewed cited consumer acceptance as a challenge  for commercializing cell-cultured meat. One study noted that  consumers have both positive and negative views toward cell-cultured  meat, which could impact their willingness to purchase and consume  such products.

FDA and USDA Have Begun to Collaborate on Oversight of Most Cell-Cultured Meat but Could More Fully Incorporate Leading Collaboration Practices

FDA and USDA have established multiple mechanisms to collaborate on  regulatory oversight of cell-cultured meat. Specifically, the agencies have  collaborated through a joint public meeting, an interagency agreement,  and three working groups. However, the interagency agreement and  working groups, which are ongoing mechanisms, do not fully incorporate  leading practices for interagency collaboration. In addition, FDA and  USDA have not documented which agency will oversee cell-cultured  seafood not covered by the interagency agreement.

FDA and USDA Have Taken Initial Steps to Collaborate on Their Oversight of Cell-Cultured Meat through Several Mechanisms

In 2018, FDA and USDA began taking steps to collaborate on the  regulatory oversight of cell-cultured meat through several mechanisms: a  joint public meeting, an interagency agreement, and three working  groups. The agencies held the joint meeting in October 2018 to discuss  the use of cell-culture technology to develop products derived from  livestock and poultry, and topics included potential hazards, oversight  considerations, and labeling. As part of this meeting, FDA and USDA held  an open public comment period from September through December  2018, gathered 315 written comments, and offered interested parties the  opportunity to offer comments in person. The agencies received public  comments from members of the public, as well as from representatives  from cell-cultured meat and conventional meat industries, food and  consumer safety groups, animal welfare groups, and environmental  organizations, among others. The written comments the agencies  received focused on such topics as environmental considerations,  labeling, potential health and safety implications, and potential regulatory  and inspection processes. Stakeholders also presented multiple  perspectives on these issues at the meeting. For example, stakeholders  expressed different views as to whether cell-cultured meat should be  regulated as a food additive, considered a GRAS substance, or whether  new regulations were needed.

In March 2019, FDA and USDA issued a formal interagency agreement  that describes the intended roles and responsibilities of each agency in  overseeing cell-cultured meat. The agreement establishes the following:

Oversight. FDA will oversee the early phases of growing cell-cultured  meat through the point of harvest. During harvest, FDA will work with  USDA to transfer regulatory oversight to USDA. USDA will then  assume oversight of cell-cultured meat through the food processing  phase, including labeling, as shown in figure 3.

Types of meat covered. The agreement covers cell-cultured meat  derived from species overseen by USDA, such as livestock, poultry,  and catfish.

Future actions. The agreement also details future actions the  agencies plan to take, such as developing a more detailed regulatory  framework or standard operating procedures and developing joint  principles for product labeling.

Reviewing and updating the agreement. The agreement states that  the agencies have the ability to modify it as needed and will review  the agreement every 3 years to determine whether they should modify  or terminate it.

In June 2019, FDA and USDA created three working groups to carry out  the terms of the interagency agreement. The working groups are  comprised of FDA and USDA officials and operate independently, though  some individuals are members of multiple groups. The groups are as  follows:

Pre-market assessment working group. Led by FDA, this group  was created to clarify the process FDA will use for pre-market reviews  of cell-cultured meat.

Labeling working group. Led by USDA, this group will focus on  developing joint principles for product labeling and claims.

Transfer of jurisdiction working group. Co-led by FDA and USDA,  this group will develop procedures for the transfer of inspection at  harvest, among other things.

According to agency officials, the working groups are still in the initial  phases of development, though some have progressed further than  others. For example, as of December 2019, the pre-market assessment  and labeling groups had met and begun to address various areas, while  the transfer of jurisdiction working group was still in discussions to outline  the roles, responsibilities, and outcomes for the group and had not held a  formal meeting.

The Interagency Agreement and Working Groups on Cell-Cultured Meat Could More Fully Incorporate Leading Collaboration Practices

FDA and USDA could more fully incorporate leading practices for  collaboration in their interagency agreement and working groups. We  have previously reported that interagency mechanisms or strategies to  coordinate programs that address crosscutting issues may reduce  potentially duplicative, overlapping, and fragmented efforts. In addition,  while collaborative mechanisms may differ in complexity and scope, they  all benefit from certain leading practices, which raise issues to consider  when implementing these mechanisms. We compared the agencies’  interagency agreement and working groups with the seven leading  practices to enhance and sustain interagency collaboration that we  previously identified. These leading practices, and examples of the  associated issues to consider, are as follows:

Defining outcomes and monitoring accountability. Is there a way  to track and monitor progress toward short-term and long-term  outcomes? Do participating agencies have collaboration-related  competencies or performance standards against which individual  performance can be evaluated?

Bridging organizational cultures. What are the commonalities  between the participating agencies’ missions and cultures, and what  are some potential challenges? Have participating agencies  developed ways for operating across agency boundaries? Have  participating agencies agreed on common terminology and  definitions?

Identifying and sustaining leadership. How will leadership be  sustained over the long term? If leadership is shared, have roles and  responsibilities been clearly identified and agreed upon?

Clarifying roles and responsibilities. Have participating agencies  clarified roles and responsibilities? Have participating agencies  articulated and agreed to a process for making and enforcing  decisions?

Including relevant participants. Have all relevant participants been  included? Do participants have appropriate knowledge, skills, and  abilities to contribute?

Identifying and leveraging resources. How will the collaborative  mechanism be funded and staffed?

Developing and updating written guidance and agreements.

If appropriate, have the participating agencies documented their  agreement regarding how they will collaborate? (A written document  can incorporate agreements reached in any or all of the following  areas: leadership, accountability, roles and responsibilities, and  resources.) Have participating agencies developed ways to  continually update or monitor written agreements?

See appendix II for a full list of the associated issues to consider for each  leading practice.

Interagency Agreement Partially Incorporates All Seven Leading Practices

We found that the interagency agreement for oversight of cell-cultured  meat partially incorporates all seven leading practices for collaboration.  For example:

Defining outcomes and monitoring accountability. The  interagency agreement partially incorporates the leading practice of  defining outcomes and monitoring progress toward these outcomes.  Specifically, the agreement identifies broad outcomes such as the  development of labeling principles. However, the agreement does not  describe how the agencies will track and monitor progress toward  outcomes.

Identifying and sustaining leadership. The agreement partially  incorporates the leading practice of clarifying leadership structures.  For example, it assigns each agency as the lead, or designates  shared leadership, for different phases of the cell-cultured meat  production process. However, the interagency agreement does not  identify how the agencies will sustain leadership over the long term,  including through succession planning. We have previously reported  that given the importance of leadership to any collaborative effort,  transitions and inconsistent leadership can weaken the effectiveness  of any collaborative mechanism.

Developing and updating written guidance and agreements. The  agreement partially incorporates the leading practice of documenting  how the agencies will collaborate. For example, the agreement  includes a method for updating the document by including a provision  that requires a review of the document every 3 years. This is  consistent with our leading collaboration practice to continually update  or monitor written agreements. However, the interagency agreement  does not document how the agencies will track and monitor progress  toward short-term and long-term outcomes.

Table 1 provides more detail about the agencies’ incorporation of these  leading collaboration practices in their interagency agreement.

FDA and USDA officials told us that the interagency agreement was  intended to be an initial, general outline for their collaboration. They also  said that as the technology to produce cell-cultured meat develops and  they implement the agreement, including developing the content of a  regulatory program, they will consider incorporating leading practices for  interagency collaboration. For example:

Clarifying roles and responsibilities. FDA and USDA officials said  in December 2019 that through the working groups the agencies  would continue to explore and define the specific details of how they  will manage their shared oversight responsibility.

Including relevant participants. FDA officials said in December  2019 that the agency would like to engage many more stakeholders  as it continues to develop its oversight of cell-cultured meat.

Identifying and leveraging resources. As of December 2019, the  pre-market assessment working group and the labeling working group  were working to identify any human resources, physical, or financial  resources they might need, according to FDA and USDA officials.

The federal food safety system is on our High Risk List due to concerns  about fragmentation, which we have reported has caused inconsistent  oversight, ineffective coordination, and inefficient use of resources. As  the agencies continue to collaborate on their shared oversight of cell- cultured meat, by more fully incorporating all seven leading practices for  collaboration into their interagency agreement, they will be better  positioned to address potential fragmentation in their efforts to ensure the  safety of the food supply as cell-cultured meat products near  commercialization and entry into the marketplace.

Working Groups Partially Incorporate or Do Not Incorporate Leading Practices

We found that the pre-market assessment, labeling, and transfer of  jurisdiction working groups that FDA and USDA created to carry out the  terms of the interagency agreement either partially incorporate or do not  incorporate the seven leading practices for interagency collaboration.  Specifically, all three working groups have partially incorporated three of  the seven leading practices for collaboration, but none of the working  groups have incorporated the four remaining leading practices. For  example:

Defining outcomes and monitoring accountability. The working  groups have all defined and agreed upon their general purposes.  However, FDA and USDA have not established methods, such as  milestones and metrics, to evaluate the progress of any of the working  groups. For example, FDA officials said in December 2019 that their  next steps are to conduct a general and qualitative risk assessment of  animal cell culture food technology to systematically identify particular  areas of interest from a food safety perspective and prepare detailed  procedural guidelines for cell-cultured meat firms to follow. However,  the officials did not have time frames or a method to evaluate  progress towards completing these actions.

Including relevant participants. While the working groups have  included relevant FDA and USDA officials, none of the groups have  included state or tribal officials in initial discussions and planning.  According to the state officials we spoke with, being excluded from  these federal-level discussions may hinder their ability to align their  safety and labeling requirements, among other things, with federal  standards.

Developing and updating written guidance and agreements. None  of the working groups have documented how they will collaborate. For  example, the working groups have not documented leadership,  accountability, roles and responsibilities, or resources needed for  working groups.

Table 2 provides more detail about FDA and USDA’s incorporation of  leading collaboration practices in the three working groups.

In December 2019, FDA and USDA officials said that as they continued to  stand up these working groups, they were considering leading practices  for collaboration. For example:

Defining outcomes and monitoring accountability. FDA and  USDA officials said they were considering means to monitor,  evaluate, or report on the results of the pre-market assessment  working group.

Including relevant participants. FDA and USDA officials said that  they were working to determine what knowledge participants in the  pre-market assessment working group and the labeling working group  needed to perform the work of the working group.

Developing and updating written guidance and agreements. FDA  and USDA officials said they were considering documenting how they  will collaborate in the pre-market assessment working group, including  potentially creating a charter for the working group.

We have previously reported that fragmentation has caused inconsistent  oversight and inefficient use of resources in the federal food safety  oversight system. The agencies’ 2019 agreement to share oversight of  cell-cultured meat creates a new relationship between FDA and USDA,  since the agencies will oversee different stages of the production of the  same food and hand off oversight at a certain point in that production.  These factors contribute to an already complicated system in which the  two agencies must coordinate on food safety oversight.

In this context, some industry representatives and other stakeholders  have expressed concerns about potential fragmentation or overlap in  oversight of cell-cultured meat, such as could occur during the harvest  phase of cell-cultured meat production when FDA hands off its oversight  to USDA. Additionally, representatives from one cell-cultured meat firm  stated that avoiding overlap in federal oversight whenever possible was  important to them. For example, representatives from one firm pointed to  inspection, record-keeping requirements, and regulations as potential  areas at risk of overlap. They stated that potential overlap would add  unnecessary, burdensome requirements and create an uneven playing  field with the conventional meat industry.

By more fully incorporating all seven leading practices for interagency  collaboration early in the development of the three working groups, FDA  and USDA could proactively minimize potential fragmentation and overlap  in their oversight of cell-cultured meat, ensure consistency and efficient  use of resources, and provide clarity to key stakeholders.

FDA and USDA Have Not Documented Which Agency Will Oversee Cell-Cultured Seafood

While FDA and USDA officials told us they have decided who will oversee  cell-cultured seafood, they have not formally announced or documented  this decision, and some stakeholders have reported confusion or  ambiguity about which agency will oversee cell-cultured seafood other  than catfish. Specifically, FDA and USDA’s interagency agreement  regarding cell-cultured meat states that it covers all cell-cultured meat  derived from USDA-amenable species required to bear a USDA mark of  inspection, which in the agreement includes livestock, poultry, and catfish.  However, the agreement does not mention cell-cultured meat made from  the cells of other fish, such as tuna and shellfish. FDA and USDA officials  told us that FDA will have sole oversight responsibility for cell-cultured  seafood other than catfish.

According to FDA officials, they have verbally communicated this decision  in various meetings with stakeholders. However, FDA and USDA officials  told us that formally documenting FDA’s sole oversight of most cell- cultured seafood in their interagency agreement was unnecessary  because FDA currently oversees most conventional seafood. According  to cell-cultured meat firms, some firms are working on developing cell- cultured versions of seafood, such as bluefin tuna. However, stakeholders  from two cell-cultured meat firms, including representatives of a cell- cultured seafood firm we spoke with in April 2019, stated that they did not  know who in the federal government would oversee cell-cultured seafood.  Representatives from one cell-cultured seafood firm said that not being  able to rule out oversight by USDA prevented them from making key  decisions regarding what direction to pursue in developing their  commercial production method.

While FDA and USDA officials told us they had agreed that FDA would  oversee cell-cultured seafood other than catfish, as of December 2019,  the agencies had not formally announced or documented this agreement.  Developing and updating written guidance and agreements is a leading  practice for collaboration, as we have previously reported. In addition,  standards for internal control in the federal government state that agency  management should externally communicate the necessary quality  information to achieve its objectives and should select appropriate  methods of communication, such as a written document or a face-to-face  meeting. Management should also periodically evaluate the entity’s  methods of communication so that the organization has the appropriate  tools to communicate quality information throughout and outside of the  entity on a timely basis. While FDA and USDA officials have informally  communicated to some stakeholders that FDA will have sole oversight of  most cell-cultured seafood, FDA has not communicated this information  formally or in a method readily available to all relevant stakeholders, such  as in their interagency agreement or other publicly available written  document.

FDA and USDA officials told us that they wanted to communicate this  information through outreach to individual firms, but FDA or USDA  officials said they did not think that revising their interagency agreement  was necessary. By taking steps to document which agency will oversee  cell-cultured seafood other than catfish, FDA and USDA will better ensure  the public, including key stakeholders such as cell-cultured meat firms,  have clarity about the agencies’ oversight responsibilities in this area.

Cell-cultured meat is a new food product that raises many questions. FDA  and USDA’s shared oversight of cell-cultured meat poses various  challenges for these agencies, as well as stakeholders such as industry.  Compounding this challenge is that specific information about key  aspects of cell-cultured meat, such as the technology and production  methods to be used as well as the composition of the products, is not yet  known.

FDA and USDA have taken steps to collaborate on their shared  regulatory oversight of cell-cultured meat, including establishing an  interagency agreement and three working groups. However, the  interagency agreement only partially incorporates the seven leading  collaboration practices that can enhance and sustain agencies’  collaborative efforts, and the working groups either partially incorporate or  do not incorporate these leading practices, which has raised concerns  about potential fragmentation or overlap in oversight. By more fully  incorporating all seven leading practices for collaboration into their  interagency agreement, FDA and USDA could build on their existing  efforts and be better positioned to sustain and enhance their collaborative  efforts. Moreover, by more fully incorporating all seven leading practices  for interagency collaboration early in the development of the working  groups, FDA and USDA could proactively minimize potential  fragmentation and overlap in their oversight of cell-cultured meat and  ensure they are utilizing resources efficiently or effectively.

Furthermore, the interagency agreement states that it covers USDA- amenable species required to bear a USDA mark of inspection, which in  the agreement includes livestock, poultry, and catfish but does not include  cell-cultured seafood other than catfish. FDA and USDA officials told us  they have decided FDA will oversee most cell-cultured seafood, but the  agencies have not formally documented this decision. By taking steps to  document in their interagency agreement, or other publicly available  document, which agency will oversee cell-cultured seafood other than  catfish, FDA and USDA could better ensure that members of the public  and other key stakeholders such as cell-cultured meat firms have clarity  about the agencies’ oversight responsibilities in this area.

We are making a total of six recommendations, three to FDA and three to  USDA:  The Commissioner of the Food and Drug Administration, in coordination  with the Secretary of Agriculture, should more fully incorporate the seven  leading practices for effective collaboration in the agencies’ interagency  agreement for the joint oversight of cell-cultured meat.   (Recommendation 1)

The Secretary of Agriculture, in coordination with the Commissioner of the  Food and Drug Administration, should more fully incorporate the seven  leading practices for effective collaboration in the agencies’ interagency  agreement for the joint oversight of cell-cultured meat.   (Recommendation 2)

As the three cell-cultured meat working groups move forward, the  Commissioner of the Food and Drug Administration, in coordination with  the Secretary of Agriculture, should more fully incorporate the seven  leading practices for effective collaboration, such as identifying specific  outcomes and a way to monitor and evaluate progress toward outcomes.  (Recommendation 3)

As the three cell-cultured meat working groups move forward, the  Secretary of Agriculture, in coordination with the Commissioner of the  Food and Drug Administration, should more fully incorporate the seven  leading practices for effective collaboration, such as identifying specific  outcomes and a way to monitor and evaluate progress toward outcomes.  (Recommendation 4)

The Commissioner of the Food and Drug Administration, in coordination  with the Secretary of Agriculture, should clearly document in their  interagency agreement, or other publicly available document, which  agency will oversee cell-cultured seafood other than catfish.  (Recommendation 5)

The Secretary of Agriculture, in coordination with the Commissioner of the  Food and Drug Administration, should clearly document in their  interagency agreement, or other publicly available document, which  agency will oversee cell-cultured seafood other than catfish.  (Recommendation 6)

We provided a draft of this report to the Department of Health and Human  Services’ (HHS) Food and Drug Administration (FDA) and the U.S.  Department of Agriculture (USDA) for review and comment. In FDA’s  comments, reproduced in appendix III, the agency stated that it values  GAO’s recognition of the importance of collaborative mechanisms that  facilitate coordination and affirmed its commitment to coordinate closely  with USDA to ensure the regulatory framework for cell-cultured meat is  clear and transparent to stakeholders. In USDA’s comments, reproduced  in appendix IV, the department stated that the report put too much focus  on best practices for interagency collaboration and not enough emphasis  on industry’s role in providing the agencies with the information they need  to move their processes forward to effectively regulate cell-cultured meat.  USDA stated that it is difficult to review a developing technology and its  future regulatory oversight when so little detailed information about the  technology is known.

We agree that the technology to produce cell-cultured meat is still in  development and that information about the commercial production  methods and composition of the final product are not yet known, as we  state in our report. We also acknowledge in our report that having limited  information can affect the agencies’ ability to make regulatory and other  decisions. We recognize that cell-cultured meat is a new food product that  raises many new questions and that specific information about key  aspects of cell-cultured meat is not yet known. In light of this challenging  context, it is all the more important that FDA and USDA more fully  incorporate leading practices for collaboration into their joint efforts in  order to ensure they are in the best possible position to oversee this new  food product.

FDA concurred with two recommendations and partially concurred with  one. USDA also concurred with two recommendations and partially  concurred with one. Specifically, both agencies agreed with our  recommendations regarding (1) more fully incorporating the seven  leading practices for effective collaboration in the three cell-cultured meat  working groups as they move forward and (2) clearly documenting which  agency will oversee cell-cultured seafood other than catfish.

FDA and USDA partially concurred with our recommendation, directed to  each agency, to more fully incorporate the seven leading practices for  effective collaboration into the agencies’ interagency agreement for the  joint oversight of cell-cultured meat. FDA stated that it concurred with the  intent of incorporating the seven leading practices into the interagency  agreement, and both agencies said that they are open to incorporating  the practices into their development of the structure for joint oversight of  cell-cultured meat. However, the agencies stated that they did not agree  to revise the agreement at this time. FDA and USDA stated that the  agreement is a general framework and that incorporating the leading  practices would constitute an inappropriate level of detail. Instead, the  agencies stated that they believe it would be most valuable to incorporate  the leading practices into a more detailed joint framework or standard  operating procedure they plan to issue.

We appreciate the agencies’ willingness to incorporate the leading  practices for effective collaboration into their efforts. The March 2019  interagency agreement states that the agencies have the ability to modify  it as needed and will review the agreement every 3 years to determine  whether they should modify or terminate it. Therefore, the agencies are  due to revisit the agreement in March 2022, if not sooner. Regarding the  agencies’ concern that incorporating the leading practices in the  interagency agreement would add an inappropriate level of detail, we  note that, as we state in our report, the existing agreement already  partially incorporates each of the seven leading practices. We continue to  believe that FDA and USDA should more fully incorporate the seven  leading practices for effective collaboration into their interagency  agreement for the joint oversight of cell-cultured meat. Developing a more  detailed joint framework or standard operating procedure in accordance  with the existing interagency agreement that incorporates those leading  practices would meet the intent of our recommendation to improve the  effectiveness of the agencies’ collaboration.

FDA and USDA also provided technical comments, which we  incorporated as appropriate.

As agreed with your office, unless you publicly announce its contents  earlier, we plan no further distribution of this report until 30 days from its  issue date. At that time, we will send copies of this report to the  appropriate congressional committees, the Secretary of Health and  Human Services, the Secretary of Agriculture, and other interested  parties. In addition, the report is available at no charge on the GAO  website at http://www.gao.gov.

If you or your staff members have any questions regarding this report,  please contact me at (202) 512-3841 or morriss@gao.gov. Contact points  for our Offices of Congressional Relations and Public Affairs may be  found on the last page of this report. GAO staff who made key  contributions to this report are listed in appendix V.

Appendix I: Objectives, Scope, and Methodology

Our report (1) describes what is known about methods for commercially  producing cell-cultured meat and (2) examines the extent to which the  Food and Drug Administration (FDA) and U.S. Department of Agriculture  (USDA) are collaborating to provide regulatory oversight of cell-cultured  meat.

For both objectives, we conducted a literature review of journal and media  articles from 2016 through 2019 to inform our understanding of cell- cultured meat, as well as regulatory activity related to cell-cultured meat  in the United States and in other countries. Specifically, we conducted a  review of scholarly and trade news from 2016 through July 2019 for  specific terms related to cell-cultured meat and regulatory approaches.  We conducted searches in more than 30 different academic and trade  databases—such as SCOPUS, Foodline, and ProQuest’s Environmental  Science Collection—and identified studies relevant to our research  objectives. In addition to these formal literature searches, we also asked  agency officials and stakeholders to refer us to research articles and  publications on cell-cultured meat.

We also reviewed documentation from FDA and USDA, including the  2019 interagency agreement, existing memoranda of understanding  between the two agencies, Federal Register notices about relevant public  meetings, and press releases. We also reviewed documentation such as  letters to regulators, presentation slides, and information on  organizations’ websites from the cell-cultured meat industry, conventional  meat industry, and consumer safety groups, among others. We also  interviewed officials from FDA and USDA and representatives of  stakeholders from the cell-cultured meat industry and industry  associations, conventional meat firms and industry associations,  academia, food and consumer safety groups, and state and tribal public  health associations, among others. We identified stakeholders to  interview through consultation with agency officials and nonfederal  stakeholders and through our review of literature. We conducted 17  interviews with representatives or researchers from:  six cell-cultured meat firms or industry associations,  four conventional meat firms or industry associations,  two food and consumer safety groups, one state and tribal public health association, and one food law policy firm.

Because this is a nongeneralizable sample, the results of these interviews  do not represent the views of all stakeholders involved in or with an  interest in the cell-cultured or conventional meat industries or federal  regulation of cell-cultured meat. However, they illustrate the range of  perspectives on these topics.

We also attended public meetings and conferences and conducted site  visits to several locations. Specifically, we attended FDA and USDA’s  public meeting in October 2018 and four conferences in 2019 that  included content pertaining to food safety or cell-cultured meat. We  conducted site visits to two conventional meat-processing facilities in  Georgia, three cell-cultured meat firms in California, an academic cell- culturing laboratory in California, and a medical cell-culturing facility in  Maryland. We identified facilities and laboratories to visit through our  literature review, online research, and the assistance of agency officials  and stakeholders, such as representatives from the cell-cultured meat  and conventional meat industry.

To describe what is known about the process for producing cell-cultured  meat and potential commercial production methods, we also reviewed  two sets of public comments submitted to FDA and USDA in association  with the two 2018 public meetings pertaining to cell-cultured meat. These  meetings were “Foods Produced Using Animal Cell Culture Technology”  in July 2018 and “Use of Cell Culture Technology to Develop Products  Derived from Livestock and Poultry” in October 2018. Public comments  were submitted by members of the public; representatives from cell- cultured meat firms and industry associations, conventional meat  companies and industry associations, food and consumer safety groups,  and animal welfare groups; and environmental organizations, among  others. We reviewed and analyzed all comments submitted to (1) FDA  related to the July 2018 meeting and (2) FDA and USDA related to the  October 2018 meeting. We also attended the October 2018 meeting and  listened to agency officials’ presentations and oral remarks made by  stakeholders and members of the public. We shared our description of  the process for making cell-cultured meat, and associated questions, with  representatives from three cell-cultured meat firms and academic  researchers at two universities for their technical review and incorporated  revisions as appropriate.

To examine the extent to which FDA and USDA are coordinating to  provide regulatory oversight of cell-cultured meat, we identified actions  they took to coordinate from July 2018 through April 2020. To identify  these actions, we interviewed agency officials, emailed agency officials  written questions, reviewed agency documentation and public  announcements, and attended public events such as the October 2018  public meeting. We compared the agencies’ interagency agreement and  working groups with seven leading practices to enhance and sustain  interagency collaboration. Specifically, two independent GAO reviewers  assessed the degree to which agencies’ actions incorporated these  leading practices. A description of these leading practices and the  associated issues to consider is in appendix II. We also assessed the  agencies’ actions against standards for internal control in the federal  government, including standards related to communicating quality  information. In this report, and in our past work, we define collaboration  as any joint activity that is intended to produce more public value than  could be produced when organizations act alone. We use the terms  “coordination” and “collaboration” interchangeably in this report.

For the purposes of our report, we define cell-cultured meat as food  derived from animal cells that were grown in a controlled environment  outside of the animal. We define cell-cultured seafood as a subcategory  of cell-cultured meat. When referencing conventional meat, we are  referring to food produced from the traditional method of slaughtering an  animal, such as a cow, hog, chicken, or fish. When referencing seafood,  we are referring to shellfish, sea fish, and freshwater fish served as food.

We conducted this performance audit from October 2018 to April 2020 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.

Appendix II: Key Issues to Consider for Implementing Interagency Collaborative Mechanisms

Appendix II: Key Issues to Consider for  Implementing Interagency Collaborative  Mechanisms Issues to consider

Have short-term and long-term outcomes been clearly defined?

Is there a way to track and monitor progress toward the short-term and long-term outcomes?

Do participating agencies have collaboration-related competencies or performance standards  against which individual performance can be evaluated?

Do participating agencies have the means to recognize and reward accomplishments related  to collaboration?

What are the missions and organizational cultures of the participating agencies?

What are the commonalities between the participating agencies’ missions and cultures and  what are some potential challenges?

Have participating agencies developed ways for operating across agency boundaries?

Have participating agencies agreed on common terminology and definitions?

Has a lead agency or individual been identified?

If leadership will be shared between one or more agencies, have roles and responsibilities  been clearly identified and agreed upon?

How will leadership be sustained over the long term?

Have participating agencies clarified the roles and responsibilities of the participants?

Have participating agencies articulated and agreed to a process for making and enforcing  decisions?

Have all relevant participants been included?

Full knowledge of the relevant resources in their agency?

The ability to regularly attend activities of the collaborative mechanism?

The appropriate knowledge, skills, and abilities to contribute?

Developing and updating written  guidance and agreements

How will the collaborative mechanism be funded? If interagency funding is needed, is it  permitted?

If interagency funding is needed and permitted, is there a means to track funds in a  standardized manner?

How will the collaborative mechanism be staffed?

Are there incentives available to encourage staff or agencies to participate?

If relevant, do agencies have compatible technological systems?

Have participating agencies developed online tools or other resources that facilitate joint  interactions?

If appropriate, have the participating agencies documented their agreement regarding how  they will be collaborating? A written document can incorporate agreements reached in any or  all of the following areas:

Have participating agencies developed ways to continually update or monitor written  agreements?

Appendix III: Comments from the U.S. Department of Health and Human Services

Appendix IV: Comments from the U.S. Department of Agriculture

Appendix V: GAO Contact and Staff Acknowledgments

Steve D. Morris, (202) 512-3841 or morriss@gao.gov  In addition to the contact named above, Nico Sloss (Assistant Director),  Angela Miles (Analyst-in-Charge), Sahar Angadjivand, Tim Bober, Kevin  Bray, Colleen Candrl, Pin En Annie Chou, Tara Congdon, Heather  Dowey, Kim Gianopoulos, Gina Hoover, Hayden Huang, Robert Lepzler,  Serena Lo, David Lysy, Marc Meyer, Michael Polak, Danny Royer, Sara  Sullivan, and Sarah Veale made key contributions to this report.

Soon, people will likely be able to buy cell-cultured meat. To make it, food animals are biopsied and their cells banked, or stored, for use. Then the meat is grown from the cells, harvested, and made into food products. Specifics on the process and the composition of the final product aren’t publicly available.

The FDA and USDA are responsible for food safety and have started oversight work on cell-cultured meat. But they haven’t followed all leading practices for interagency collaboration. Improving how they work together can help them use their resources more efficiently.

Our recommendations address this and other issues we found.