FDA has released new regulatory processes for intentional genomic alterations (IGAs) in animals, citing the need to update due to evolving science and innovations in animal biotechnology. “These updated guidance documents demonstrate our commitment to facilitating innovation while ensuring product safety,” Tracey Forfa, director of FDA’s Center for Veterinary Medicine, said in a prepared statement. “These technologies hold great promise for many uses and public and animal health benefits, such as animal disease resistance, control of zoonotic disease transmission, improved animal husbandry, and increased food production and quality.”

Elizabeth Presnell, an attorney with Food Industry Counsel, tells Food Quality & Safety that IGAs in animals refer to modifications made to an animal’s genomic DNA using advanced molecular technologies, and FDA has established a risk categorization that splits IGAs into three categories based on risk to both animals and the food supply. “Category 1 is alterations not subject to approval; category 2 is going through a partial approval process where FDA will evaluate the risk and then determine whether or not the alteration needs to go through full approval; and then category 3 is where there is a risk to the food supply where a full approval will be undertaken.”

She explains that this will look a lot like what drug approvals currently undergo.

Mike Schmidt, an attorney from Schmidt and Clark who focuses on food safety and regulatory compliance, calls this a significant development that could have profound impacts on food safety in the years ahead. “This modernization could result in greater regulatory flexibility, pre­dictability, and efficiency,” he tells FQ&S. “For example, the FDA may not require developers of specific types of IGAs in animals to file an application or obtain FDA approval before marketing their product. This could speed up the introduction of these products to the market.”

Some experts believe that the expedited process may raise food safety concerns. While genomic changes can provide advantages such as disease resistance, heat tolerance, faster growth, and feed efficiency, they may also introduce new risks. “For example, changes that result in faster growth may have an impact on the nutritional value of the food produced by these animals,” Schmidt says. “Therefore, it’s crucial that these products are thoroughly evaluated for their potential impacts on food safety before they are introduced into the market.”

In this regard, FDA has established a memorandum of understanding with USDA to clarify roles and responsibilities for regulating IGAs in animals. “It’s an interesting action by FDA as there are critics on both sides,” Presnell says. “With animal agriculture geneticists saying this isn’t going far enough, and then people opposing it because some of the processes are easier to achieve.”

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To further protect the U.S. livestock industry from the threat posed by highly pathogenic H5N1 avian influenza, USDA has announced that it is taking specific actions with its federal partners to limit the disease’s spread.

USDA’s Animal and Plant Health Inspection Service (APHIS) announced a Federal Order requiring the following measures, effective Monday, April 29, 2024:

Mandatory Testing for Interstate Movement of Dairy Cattle

• Prior to interstate movement, dairy cattle are required to receive a negative test for Influenza A virus at an approved National Animal Health Laboratory Network laboratory.
• Owners of herds in which dairy cattle test positive for interstate movement will be required to provide epidemiological information, including animal movement tracing.
• Dairy cattle moving interstate must adhere to conditions specified by APHIS.
• As will be described in forthcoming guidance, these steps will be immediately required for lactating dairy cattle, while these requirements for other classes of dairy cattle will be based on scientific factors concerning the virus and its evolving risk profile.

Mandatory Reporting

• Laboratories and state veterinarians must report positive Influenza A nucleic acid detection diagnostic results (e.g. PCR or genetic sequencing) in livestock to USDA APHIS.
• Laboratories and state veterinarians must report positive Influenza A serology diagnostic results in livestock to USDA APHIS.

USDA has identified spread between cows within the same herd, spread from cows to poultry, spread between dairies associated with cattle movements, and cows without clinical signs that have tested positive. On April 16, APHIS identified a shift in an H5N1 sample from a cow in Kansas that could indicate that the virus has an adaptation to mammals.

CDC conducted further analysis of the specimen sequence, which did not change their overall risk assessment for the general public, because the substitution has been seen previously in other mammalian infections and does not impact viral transmission. Additionally, the APHIS National Veterinary Services Laboratories found H5N1 in a lung tissue sample from an asymptomatic cull dairy cow that originated from an affected herd and did not enter the food supply.

The novel movement of H5N1 between wild birds and dairy cows requires further testing and time to develop a critical understanding to support any future courses of action, USDA said in a statement, adding that requiring positive test reporting will help the agency better under the disease and testing before interstate movement will limit its spread.

The agency has not found changes to the virus that would make it more transmissible to humans and between people and CDC believe that the current risk to the public remains low.

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In early August, USDA previewed the Organic Livestock and Poultry Standards (OLPS) proposed rule in the Federal Register. This rule proposes requirements for organic poultry and livestock living conditions, care, transport, and slaughter.

The rule would change USDA organic regulations to promote a fairer and more competitive market for organic producers, the agency said in a statement, by making sure that certified USDA livestock products are produced to the same consistent standard.

When finalized, the agency’s National Organic Program (NOP) will oversee the rule’s implementation. In partnership with USDA-accredited certifying agents, NOP’s oversight supports growth of the organic market, including farmers and businesses interested in transitioning to organic, says USDA.

In addition to accepting comments, NOP will host a public webinar listening session on August 19 to hear oral comments on the proposed rule. More information about the proposed Organic Livestock and Poultry Standards rule and how to make comments is available on the AMS website.

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The global market for turkey products continues to increase steadily each year, with the U.S. producing nearly 43% of the global turkey meat output, according to IndexBox estimates. Hundreds of Salmonella cases are linked to turkeys each year. In 2018, an outbreak of Salmonella Reading caused 358 people from 42 states to become ill. The outbreak was caused by raw turkey products, according to Centers for Disease Control and Prevention (CDC) and USDA Food Safety and Inspection Service (FSIS) reports. An August 2018 USDA report on the aggregate Salmonella categorization of turkey establishments revealed that 50% of processing plants exceeded the maximum allowable positive tests for turkey comminuted products.

With increased pressure from regulators and consumers to ensure safe turkey products, turkey producers must continue to develop Salmonella control programs aimed at reducing Salmonella infections in live-side production. With the impacts of product recalls and company reputations at stake, it’s important for live-side production to consider disease mitigation strategies such as biosecurity measures and the use of vaccines to reduce Salmonella contamination of raw turkey products.

Reducing Salmonella contamination in turkey products takes effort from the entire supply chain, and infection control strategies on the live side play a large role in helping processing plants meet USDA FSIS performance standards.

Implement Biosecurity Measures

Operations need to develop a comprehensive Salmonella prevention control plan that includes feed mills, breeder and commercial turkey facilities and hatcheries, and assess risks regularly.

Biosecurity is the proactive approach to safeguarding the health and productivity of your flock. There are three major requirements for biosecurity: isolation, traffic control, and sanitation. Isolation refers to confining animals in a minimized environment. Traffic control is reducing the amount of equipment and personnel onto and around the operation. Sanitation includes disinfecting materials and equipment entering the farm, plus maintaining cleanliness of the personnel who work in and around the facility.

Biosecurity is an important step to ensuring that a flock’s exposure to Salmonella is minimized to reduce infections in birds before they enter the processing facility.

Mitigation with Vaccines in Poultry

While producers are applying many interventions to target Salmonella in live production, vaccination of commercial turkeys against Salmonella is one that is gaining traction.

In 2018, Elanco partnered with a turkey producer to study the efficacy of Salmonella vaccines by assessing ground turkey samples for the presence of Salmonella, including S. Reading. The study involved evaluating Salmonella presence in ground turkey samples before and after a vaccination program began. The turkey producer began vaccinating commercial poults applied by a coarse spray at placement and again around three weeks of age. Organic and antibiotic-free vaccinated toms entered the processing plant on November 12, 2018, and vaccinated conventional toms entered the plant on January 21, 2019.

A total of 557 ground turkey samples were collected between August 8, 2018, and May 31, 2019, to test the prevalence of Salmonella during the pre-vaccination period, during the transition period when mixed populations of non-vaccinated and vaccinated flocks entered processing, and after January 21, 2019 when 100% of the flocks that entered processing were fully vaccinated Figure 1 (below) shows that overall Salmonella prevalence was reduced by approximately 35% in the ground turkey samples tested during the period when 100% of fully vaccinated flocks entered processing, and the prevalence of S. Reading was reduced by approximately 57%.

Figure 1

Simply put, when included in a comprehensive biosecurity program, a live Salmonella vaccination program aids in stimulating immunity and providing protection against Salmonella infections in a turkey production environment when compared with other vaccines.

Focusing on a holistic approach that includes biosecurity best management practices and a continuum of vaccination throughout the live side provides significant benefit to processing plants in helping to reduce Salmonella contamination in turkey products.

The label contains complete use information, including cautions and warnings. Always read, understand and follow the label and use directions.

Aehle is an associate advisor, Elanco Poultry Food Safety. Reach her at sandy.aehle@elancoah.com.

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The dairy and cattle industries will have collapsed by 2030 and the rest of the livestock industry will follow, according to a new report.

The report, by independent think tank RethinkX, also predicts that by 2030, modern food products will be higher quality and cost less than half the price of animal-derived foods.

credit: Reuters

The food and agriculture research fellows who wrote the report emphasized that although the industrial livestock industry is one of the oldest and largest in the world, it’s also one of the most inefficient food-production systems. This analysis focuses on the new technologies driving the transformation of the food and agriculture sectors and the inevitable implications for the cattle industry in the U.S.

Modern ingredients, such as plant proteins and engineered foods, are about 10 times more efficient across the board—from land, energy and water use to feedstock consumption.

“We are on the cusp of a protein revolution that is driven by economics, such that the cost of manufactured proteins will be five times cheaper by 2030 and 10 times cheaper by 2035 than existing animal proteins,” says Catherine Tubb, senior analyst for Rethink X, who co-wrote the report. “These cheaper and cheaper proteins are just going to make industrial animal production method obsolete by 2030.”

That means important decisions regarding the environment, jobs, education, politics, and land use need to be made sooner rather than later.

“The whole food system will change and the new production system will allow for food to be produced anywhere, so we expect to see more of a local production, just like beer is brewed now,” Tubb says. “That means less time to move food, supply chains will completely change, and food won’t need to move through different continents as much.”

Safety Standards
For this consumer-driven market, product quality, safety, and sustainability are of utmost concern. A more localized food source should mean better safety, as it’s less likely that food gets contaminated or spoiled on shipments during transportation.

“I just think even how food will be produced, in a closed system, you’re not going to see contamination coming in, like you might see with meat in a slaughterhouse or any dairy system,” Tubb says. “But it still needs to be regulated and we do advocate for transparency in our report in anticipation of these modern foods so they are safe.”

The USDA and FDA are still working on food regulations for alternative proteins, and RethinkX advocates for an independent regulatory body to develop policy and oversee new technology. This would be done to limit the potential backlash from the lobbying power of those currently in the food industry.

“You wouldn’t need the same safety checks that you would on a farm, so it will impact both the USDA and FDA,” Tubb says.

The World Economic Forum released a white paper in January 2019 in which it reported that alternative proteins promote food security by releasing land currently used to grow animal feed for the production of human food.

Traceability Concerns Grow
Adnan Durrani, CEO of Saffron Road Foods, who wasn’t involved in the report, predicts that in the years ahead, ethical consumerism will continue to rise.

“2019 was the year of faux meat alternatives and the power of plants,” he says. “Consumers, particularly millennials and Gen Zers, became more aware of the impact that their food choices make on our planet and sustainability has been at the forefront of food trend conversations.”

He says plant proteins will rise to the top in 2020 as meat eaters transition to plant-based foods and people choose ingredients that are healthier, more economical and more sustainable. And it’s all about transparency.

“Say goodbye to ambiguous labels and hello to more brands that are committing to full transparency with consumers demanding clean-label foods and third-party certifications,” he says.

Durrani also foresees more humane animal practices in our food system.

“As consumers become more educated, they will demand better treatment of animals throughout their life—family owned, sustainable farms, livestock humanely raised, 100 percent vegetarian feed, antibiotic-free, etc.,” he says.

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CHICAGO, Oct 2 (Reuters) – China’s hog herd fell by half in the first eight months of 2019 due to a devastating outbreak of African swine fever and will likely shrink by 55% by the end of the year, analysts at Rabobank said on Wednesday.

The pace of herd losses will likely slow in the coming months due to reduced farm numbers and Chinese government measures to control the pig disease in the world’s largest pork consumer, according to a report by Rabobank. However, the bank said relatively unstable market conditions will likely persist for the next three to five years.

Though not harmful to humans, African swine fever is deadly to hogs, with no vaccine available. It surfaced for the first time in Asia more than a year ago, in China, and has now spread to over 50 countries, according to the World Organisation of Animal Health – including those that account for 75% of global pork production.

Rabobank said in the report it expects China’s pork production to fall by 10% to 15% in 2020, on top of a 25% drop in 2019.

China’s total consumption of animal feed such as soy will drop by 17% in 2019 due to the decline in hogs, according to Rabobank. But feed consumption will rebound by 8% in 2020 as hog herds are rebuilt and farmers produce other proteins like chicken, the bank said.

In Vietnam, the world’s sixth-largest pork producer, 25% of the country’s total pig herd could be lost to African swine fever by year’s end, according to Rabobank. Since February, 18% of pigs have died, the bank said. (Reporting by Tom Polansek in Chicago Editing by P.J. Huffstutter and Matthew Lewis)

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The USDA Food Safety and Inspection Service (FSIS) and the U.S. Department of Health and Human Services’ (HHS) FDA announces a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry.

FSIS and FDA released a formal agreement to address the regulatory oversight of human food produced using this new technology. The formal agreement describes the oversight roles and responsibilities for both agencies and how the agencies will collaborate to regulate the development and entry of these products into commerce. This shared regulatory approach will ensure that cell-cultured products derived from the cell lines of livestock and poultry are produced safely and are accurately labeled.

“Consumers trust the USDA mark of inspection to ensure safe, wholesome and accurately labeled products,” said USDA Deputy Under Secretary for Food Safety Mindy Brashears. “We look forward to continued collaboration with FDA and our stakeholders to safely regulate these new products and ensure parity in labeling.”

“We recognize that our stakeholders want clarity on how we will move forward with a regulatory regime to ensure the safety and proper labeling of these cell-cultured human food products while continuing to encourage innovation,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response. “Collaboration between USDA and FDA will allow us to draw upon the unique expertise of each agency in addressing the many important technical and regulatory considerations that can arise with the development of animal cell-cultured food products for human consumption.”

Under the formal agreement, the agencies agree upon a joint regulatory framework wherein FDA oversees cell collection, cell banks, and cell growth and differentiation. A transition from FDA to FSIS oversight will occur during the cell harvest stage. FSIS will oversee the production and labeling of human food products derived from the cells of livestock and poultry.

On Oct. 23-24, 2018, FSIS and FDA held a joint public meeting to discuss the use of cell culture technology to develop products derived from livestock and poultry. The public meeting focused on the potential hazards, oversight considerations, and labeling of cell cultured food products derived from livestock and poultry.

The FSIS, an agency within the USDA, is the public health agency responsible for ensuring that nation’s meat, poultry, and egg products are safe, wholesome, and accurately labeled.

The FDA, an agency within the HHS, is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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FDA and USDA’s Food Safety and Inspection Service (FSIS) will hold a joint public meeting on October 23-24 in Washington, D.C., to discuss the use of cell culture technology to develop products derived from livestock and poultry.

The joint public meeting will focus on the potential hazards, oversight considerations, and labeling of cell cultured food products derived from livestock and poultry.

“This is an important opportunity to hear from the agricultural industry and consumers as we consider the regulatory framework for these new products,” said U.S. Secretary of Agriculture Sonny Perdue, DVM, in a press release. “American farmers and ranchers feed the world, but as technology advances, we must consider how to inspect and regulate to ensure food safety, regardless of the production method.”

“The FDA knows just how vital it is to ensure the safety of our nation’s food supply and the critical role science-based, modern regulatory frameworks are to fostering innovation. Recent advances in animal cell cultured food products present many important and timely technical and regulatory considerations for the FDA and our partners at USDA,” said FDA Commissioner Scott Gottlieb, MD. “We look forward to the opportunity to hold a meeting with our USDA colleagues as part of an open public dialogue regarding these products.”

The first day of the meeting will focus primarily on the potential hazards that need to be controlled for the safe production of animal cell cultured food products and oversight considerations by regulatory agencies. The second day of the meeting will focus on labeling considerations.

Representatives of industry, consumer groups, and other stakeholders are invited to participate in the meeting. Attendees are encouraged to pre-register to attend the meeting. Pre-registration is available at the Meetings and Events page on the FSIS website.

Anyone who wishes to submit written comments prior to the public meeting or after the meeting may do so by submitting comments on regulations.gov by Nov. 26, 2018. Comments previously submitted to FDA in regard to the July 12, 2018 public meeting will also be considered.

For further information on the joint public meeting and to register to attend the meeting, visit the Meetings and Events page on the FSIS website. Attendance is free.

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The U.S. is experiencing a shortage of veterinarians, especially ones who specialize in livestock, which has the potential to hurt the nation’s food supply.

Veterinarians play an important role in every step of the food production process from farm to plate, and food supply veterinarians are critical to ensuring a safe and secure food supply across the nation and around the world.

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Much popular discussion about facial recognition software recently has centered on Apple’s facial-ID security systems—but agricultural scientists have been working toward an entirely different use for the technology. At the end of January, Minnesota’s Cargill announced that it was partnering with the Dublin-based machine-vision company Cainthus in order to develop facial-recognition technology that will monitor the health and well-being of dairy livestock.

This proprietary software will rely on attention to images to monitor both faces and animal hides. Their technology, Cargill and Cainthus contend, will make it possible to use computer-imaging software to monitor food and water intake, body temperature, resting and sitting time, and environmental conditions in order to keep better track of animal health and welfare.

“This technology will dramatically change how farmers take care of their animals,” Tim Loesch, animal nutrition communications director, Cargill, tells Food Quality & Safety. “This technology will allow farmers to treat animals and take care of those with the greatest need, rather than always focusing on an entire herd. This allows farmers to have a more surgical and specific approach to make sure animals are cared for.”

The new technology takes several seconds to identify individual cows and store their data, which extends to pattern and movements. An artificial intelligence-based algorithm derives information about food and water intake, behavioral tracking, and health status, and sends alerts directly to farmers. Ideally, this should provide farmers the opportunity to meet health challenges preemptively and also to adjust feeding and water quickly.

“We are enthused about what this partnership will mean for farmers across the world,” Cainthus president and co-founder David Hunt said in a press release. “Cargill is a natural partner for us, given their focus on bringing a world-class digital capability to the market and their understanding of how technology will truly help farmers succeed. We think this partnership will be a game changer for farmers because it will allow them to efficiently scale their business.”

Loesch says that the partners were focused on marketing the technology in the U.S. and Europe at the present time, but planned to make their product available to markets worldwide over the next twelve months.

Not everyone is enthused about it, however. Mark A. Kastel, co-founder of Wisconsin non-profit farm-policy research group the Cornucopia Institute, worries about the decline in human engagement in farming.

“We are moving farther and farther away from true, ethical animal husbandry where families have a connection to individual members of their herds,” Kastel tells Food Quality & Safety. “Many family-scale farmers have cows with names, not numbers. For dairy farmers, who see their cattle every day, small nuances can tell them when they are dealing with a health problem and can treat them early on to maintain their quality and length of life.”

Kastel questions the humane ethics of animals being seen as “production units” fit to be worked upon by robotic milkers, or by workers who do not own or know the animals.

“As that happens, something is lost as a society,” he says. “We are all responsible, directly or indirectly, for the quality of life of the animals who contribute to our health and enjoyment as we eat every day.”

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