• On February 22, 2024, the U.S. Food and Drug Administration (FDA) issued a guidance for industry that addresses how firms should voluntarily engage with the Agency before marketing food produced from genome-edited plant varieties.  The guidance reaffirms that the risk-based approach FDA has taken for foods derived from genetically engineered plans under the new plant variety policy also applies to the newer foods from genome-edited plants. 
  • FDA identifies and describes two processes by which firms may voluntarily inform FDA of steps they have taken to ensure food safety: (1) voluntary premarket consultations and (2) voluntary premarket meetings.  The voluntary premarket meeting is recommended for developers to inform the Agency of their foods when a voluntary premarket consultation is not warranted based on the food’s risk-based characteristics.  Voluntary premarket consultations are advised for products that are more likely to raise safety questions.
  • FDA’s Plant Biotechnology Consultation Program intends for developers to engage with the agency to determine appropriate oversight pathways to bring safe, innovative plant-based products to market.  Foods from genome-edited plants must meet the same food safety requirements as foods derived from traditionally bred plants.
  • FDA is currently accepting public comments on the draft guidance.  Keller and Heckman will continue to monitor and relay any developments in this area and can assist with any comment submissions.
  • On June 27, 2022, FDA’s Center for Veterinary Medicine (CVM) announced that it had published a pre-recorded animal biotechnology case study webinar. The webinar addresses the agency’s risk-based review process for intentional genomic alterations (IGAs) in animals that may pose a low risk.
  • As previously reported, on March 7, 2022, FDA announced its first low-risk determination for the marketing of products from genome-edited beef cattle and their offspring, following a safety review. CVM’s webinar uses this evaluation as a case study to provide insight into how the agency reached its determination that the IGA did not raise any safety concerns.
  • By way of background, IGAs in animals are changes to an animal’s genomic DNA that are produced using modern molecular technologies, such as random or targeted DNA sequence changes. The intended uses for IGAs in animals include applications in human health (e.g., reducing allergenicity), improved animal health (e.g., disease resistance), and enhanced production of food quality (e.g., feed efficiency).  FDA’s draft guidance notes that FDA will exercise enforcement discretion where it determines that alterations present a low risk of harm.
  • CVM will accept feedback and questions regarding the webinar at FDA-CVM-Animal-Biotechnology-Feedback@fda.hhs.gov. Additional resources on IGAs can be found here.
  • On March 7, 2022, FDA announced that it had made a low-risk determination for two beef cattle (and their offspring) which contain an intentional genomic alteration (IGA) which results in short, slick-hair coating that is potentially able to withstand heat better. As a result, FDA will exercise it its enforcement discretion, and marketing of products from these cattle and their offspring, including for food uses, will not require pre-market approval.
  • Genetic alterations may be accomplished by incorporating spliced DNA sequences into animals through random integration events or, as is the case here, by using genome editing technologies (e.g., CRISPR) to introduce genetic alterations at specific sites. Both types of technologies result in IGAs which are regulated as animal drugs because the genomic alternation is intended to affect the structure and function of the body of the animal, and in some cases, is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in the animal. See 21 USC 321(g)(1) for the definition of “drug”. Thus, as a general matter, pre-market approval for each IGA is required.
  • However, as discussed in FDA’s Draft Guidance, FDA will exercise enforcement discretion where it determines such alterations present a low risk of harm. In this case, the IGA in the two beef cattle (called “PRLR-SLICK”) was found to be low risk because it is equivalent to naturally occurring mutations and results in the same short, slick hair trait found in conventionally raised cattle that have a history of safe use in agriculture and food production.
  • This is the first such determination that FDA has made for an animal intended for use in food. Thus, the FDA determination provides insight into how FDA determines that an IGA for animals for food use will be considered low-risk. A list of all IGA enforcement discretion determinations can be found here.

 

  • Whole genome sequencing (WGS) determines the order of all of the DNA building blocks (nucleotides) in an organism’s entire genome in a single laboratory process.  A comparison of the DNA sequence of an isolated bacterial pathogen to the sequences from other samples in a DNA database can pinpoint the source of a foodborne disease outbreak.  The analytical tools for WGS have become increasingly accurate, easy, and affordable such that health agencies have moved to WGS as the preferred tool for investigating foodborne illnesses from Listeria, Salmonella, and pathogenic strains of Escherichia coli, including E. coli O157:H7.

 

  • As reported here, the United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) held a meeting to discuss the state of the art and FSIS’s plans for collecting and analyzing WGS data for bacteria isolated from official samples.  For fiscal year 2017, all bacterial pathogens isolated under FSIS testing programs have been analyzed in parallel using both pulsed-field gel electrophoresis (PFGE) analysis and WGS.  A FSIS Constituent Update (December 14, 2018) announces that FSIS will suspend routine PFGE analysis and transition to using only WGS for Shiga toxin-producing E. coli (STEC), effecting January 15, 2019, and for Salmonella isolates, effective March 15, 2019.

 

  • FSIS inspects almost 6,500 establishments daily and collects a very large volume of microbial samples on a routine basis.  Under the FSIS Microbial Testing Program for Ready-To-Eat (RTE) Meat and Poultry in 2017, for example, FSIS collected and analyzed 6,892 RTE food samples for Salmonella and Listeria monocytogenes (Lm) and analyzed 4,614 samples from food-contact surfaces for Lm.  As the technology expands, WSG will become an increasingly valuable tool for quickly tracing diseases to their source and perhaps someday identifying pathogens in the environment early enough to prevent contamination of food altogether.

 

  • Whole genome sequencing (WGS) provides insight into the genetic fingerprint of a pathogen by sequencing the chemical building blocks that make up its DNA and is increasingly being employed in food safety efforts. Since 2012, the U.S. Food and Drug Administration (FDA) has regularly turned to WGS to better understand foodborne pathogens, including identifying the nature and source of microbes that contaminate food and cause outbreaks of foodborne illness.
  • This week, the Centers for Disease Control and Prevention (CDC) announced that the use of whole genome sequencing to monitor for outbreaks of Listeria, Salmonella, Campylobacter and coli that are commonly transmitted through food and animal contact has expanded to 38 states and two cities. This data is reported in the CDC’s Antibiotic Resistance (AR) Investment Map, which shows early progress by states to combat antibiotic resistance. This year’s Antibiotic Resistance Investment Map features more than 170 state-reported successes, including rapidly identifying and containing rare and concerning resistant germs to protect communities. Each state reported multiple successes.
  • You can learn more about CDC’s AR Solutions Initiative and ongoing work to combat antibiotic resistance at cdc.gov/DrugResistance.
  • Whole genome sequencing (WGS) provides insight into the genetic fingerprint of a pathogen by sequencing the chemical building blocks that make up its DNA and is increasingly being employed in food safety efforts.  Since 2012, the U.S. Food and Drug Administration (FDA) has regularly turned to WGS to better understand foodborne pathogens, including identifying the nature and source of microbes that contaminate food and cause outbreaks of foodborne illness. In 2012, FDA launched GenomeTrakr.  GenomeTrakr is an international network of laboratories that sequences microbial foodborne pathogens and uploads the data to a common public database in real time.
  • At a recent Codex Alimentarius Commission meeting in Geneva, FDA scientists explained that WGS has fundamentally changed the way microbiological food hazards in the U.S. are detected and noted that the most effective use of WGS in foodborne disease surveillance requires coordination and collaboration.
  • The FDA hopes that other countries currently using WGS will share their data with GenomeTrakr. FDA is aiming to include developing countries as they are able to join. As it stands, GenomeTrakr consists of 13 federal labs, 25 state health and university labs, one U.S. hospital lab, two other labs located in the U.S., 20 labs located outside of the U.S., and collaborations with independent academic researchers.
  • To date, GenomeTrakr has collected more than 142,000 sequenced strains.  Proponents of WGS proffer that greater availability and coordination of WGS data could go a long way towards helping to identify the source and extent of outbreaks more quickly so fewer people get sick from preventable foodborne illnesses.
  • Whole genome sequencing (WGS) provides insight into the genetic fingerprint of a pathogen by sequencing the chemical building blocks that make up its DNA and is increasingly being employed in food safety efforts.  Since 2012, the U.S. Food and Drug Administration (FDA) has regularly turned to WGS to better understand foodborne pathogens, including identifying the nature and source of microbes that contaminate food and cause outbreaks of foodborne illness. For example, FDA reports that WGS was recently used to help match samples of soft cheese to the genetic fingerprint of Listeria monocytogenes involved in a deadly foodborne illness outbreak in early March 2017.
  • On September 22, 2017, the Food Safety and Inspection Service (FSIS) announced that it will host a public meeting on October 26 and 27, 2017, to discuss overall federal food safety agency practices and, more specifically, plans for collecting and analyzing whole genome sequence (WGS) data of bacteria isolated from official samples, including the state of the science and other issues surrounding use of this technology. During the meeting, FSIS also intends to discuss the Agency’s recent experience in using WGS as well as its intention to expand its use in the future.
  • It remains to be seen the extent to which WGS may potentially revolutionize the way in which food regulatory bodies – in the U.S. and abroad – achieve their enumerated food safety and public health goals.
  • For further information concerning the upcoming October 26–27, 2017, please visit the FSIS Meetings and Events page.
  • As background, whole genome sequencing (WGS) essentially provides insight into the genetic fingerprint of a pathogen by sequencing the chemical building blocks that make up its DNA.  Since 2012, FDA has regularly turned to WGS to better understand foodborne pathogens, including identifying the nature and source of microbes that contaminate food and cause outbreaks of foodborne illness. For example, FDA reports that WGS was recently used to help match samples of soft cheese to the genetic fingerprint of Listeria monocytogenes involved in a deadly foodborne illness outbreak in early March 2017.
  • Two FDA officials leading the Agency’s WGS efforts in the food safety realm recently explained in a podcast that FDA laboratories are currently testing new genome sequencers that are said to be faster, cheaper and more mobile – with the potential to fit into a briefcase that could go out to the consumer safety officer and actually do field testing.  FDA is also working with global partners to advance this technology.
  • It remains to be seen the extent to which WGS may potentially revolutionize the way in which food regulatory bodies, including the FDA, achieve their enumerated food safety and public health goals.
  • As our readership is well aware, foods from genetically engineered (GE) plants must meet the same food safety requirements as foods derived from traditionally bred plants under the Federal Food, Drug, and Cosmetic Act.  As a routine premarket step, developers of new plant varieties, including those produced using genome editing, typically consult with FDA regarding the safety and regulatory status of foods derived from such plants.  These consultations serve to help ensure that applicable safety and legal questions are resolved prior to marketing.
  • To complement the existing framework in place for assuring the safety of products of biotechnology, including new plant varieties produced using genome editing, on September 16, 2016, the Obama administration’s Emerging Technologies Interagency Policy Coordination Committee released a National Strategy for Modernizing the Regulatory System for Biotechnology Products.  This strategy document sets forth a vision for ensuring that the federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology.
  • On January 18, 2017, FDA issued a request for comments related to the regulation of human and animals foods derived from plants produced using genome editing technologies to help inform its regulatory approach.  The Agency’s questions, include, but are not limited to:
    • In what ways are the food safety risks associated with human and animal foods from genome edited plants the same as or different from those associated with other plant development methods (g., hybridization, chemical or radiation-induced mutagenesis and non-targeted genetic modifications using in vitro recombinant DNA technologies)?
    • Are there categories of genome edited plant varieties for which there are scientific bases to conclude that foods from such categories are unlikely to present food safety risks different from or greater than those for traditional plant breeding?
    • Are there categories of genome edited plant varieties for which there are scientific bases to conclude that foods from these categories are more likely than traditionally-bred plants to present food safety risks?; and
    • What steps can FDA take to help small firms, including those who may be considering using genome editing to produce new plant varieties for use in human or animal food, to engage with FDA about any questions related to food safety or the regulatory status of foods from their new plant varieties?
  • FDA will be accepting comments until April 19, 2017.  It remains to be seen how the information received will impact the new administration’s approach to regulating foods derived from genome edited plants.