USDA, HHS Announce New Actions to Reduce Impact and Spread of H5N1

On March 25, 2024, immediately following the first detection of H5N1 in dairy cattle in the Texas panhandle region, USDA and HHS began their work to understand the origin of the emergence and its potential impact in bovines and humans. USDA experts also took swift action to trace animal movements, began sampling to assess the disease prevalence in herds, and initiated a variety of testing activities to confirm the safety of the meat and milk supplies alongside federal partners. On April 1, 2024, Texas reported the first and only confirmed human H5N1 infection associated with this outbreak, after confirmation by CDC. On April 24, 2024, USDA issued a Federal Order, that took effect on April 29, to limit the movement of lactating dairy cattle and to collect and aggregate H5N1 test results to better understand the nature of the outbreak.

Since the detection of H5N1 in dairy cattle, the Federal response has leveraged the latest available scientific data, field epidemiology, and risk assessments to mitigate risks to workers and the general public, to ensure the safety of America’s food supply and to mitigate risk to livestock, owners, and producers. Today, USDA is taking a series of additional steps to help achieve these goals and reduce the impact of H5N1 on affected premises and producers, and HHS is announcing new actions through the CDC and FDA to increase testing and laboratory screening and testing capacity, genomic sequencing, and other interventions to protect the health and safety of dairy and other potentially impacted food items.

USDA

Today, USDA is announcing assistance for producers with H5N1 affected premises to improve on-site biosecurity in order to reduce the spread. In addition, USDA is taking steps to make available financial tools for lost milk production in herds affected by H5N1. Building on the Federal Order addressing pre-movement testing, these steps will further equip producers with tools they can use to keep their affected herds and workers healthy and reduce risk of the virus spreading to additional herds.

Protect against the potential for spread between human and animals. Provide financial support (up to $2,000 per affected premises per month) for producers who supply PPE to employees and/or provide outerwear uniform laundering, for producers of affected herds who facilitate the participation of their workers in USDA/CDC workplace and farmworker study.

Complementary to USDA’s new financial support for producers, workers who participate in the study are also eligible for financial incentives to compensate them for their time, regardless of whether the study is led by federal, state, or local public health professionals.

Support producers in biosecurity planning and implementation. Provide support (up to $1,500 per affected premises) to develop biosecurity plans based on existing secure milk supply plans. This includes recommended enhanced biosecurity for individuals that frequently move between dairy farms – milk haulers, veterinarians, feed trucks, AI technicians, etc. In addition, USDA will provide a $100 payment to producers who purchase and use an in-line sampler for their milk system.

Provide funding for heat treatment to dispose of milk in a bio secure fashion. This will provide producers a safe option for disposal of milk. Heat treatment performed in accordance with standards set by FDA is the only currently available method considered to effectively inactivate the virus in milk. If a producer establishes a system to heat treat all waste milk before disposal, USDA will pay the producer up to $2,000 per affected premises per month.

Reimburse producers for veterinarian costs associated with confirmed positive H5N1 premises. This provides support to producers to cover veterinary costs necessarily incurred for treating cattle infected with H5N1, as well as fees for veterinarians to collect samples for testing. This can include veterinary fees and/or specific supplies needed for treatment and sample collection. Veterinary costs are eligible to be covered from the initial date of positive confirmation at NVSL for that farm, up to $10,000 per affected premises.

Offset shipping costs for influenza A testing at laboratories in the National Animal Health Laboratory Network (NAHLN). USDA will pay for the cost of shipping samples to NAHLN labs for testing. USDA will pay actual shipping costs, not to exceed $50 per shipment for up to 2 shipments per month for each affected premises. Testing at NAHLN laboratories for samples associated with this event (e.g., pre-movement, testing of sick/suspect animals, samples from concerned producers) is already being conducted at no-cost to the producer.

Taken together, these tools represent a value of up to $28,000 per premises to support increased biosecurity activities over the next 120 days.

Compensate producers for loss of milk production. USDA is taking steps to make funding available from the Emergency Assistance for Livestock, Honey Bees, and Farm-raised Fish Program (ELAP) to compensate eligible producers with positive herds who experience loss of milk production. While dairy cows that have been infected with H5N1 generally recover well, and there is little mortality associated with the disease, it does dramatically limit milk production, causing economic losses for producers with affected premises. USDA can support farmers with the ELAP program to offset some of these losses. This compensation program is distinct from the strategy to contain the spread.

Work with states to limit movement of lactating cattle. Additionally, USDA will work with and support the actions of States with affected herds as they consider movement restrictions within their borders to further limit the spread of H5N1 between herds to reduce further spread of this virus.

USDA will make $98 million in existing funds available to APHIS to fund these initiatives. If needed, USDA has the authority, with Congressional notification, to make additional funds available.

These additional measures build on a suite of actions USDA has taken to date. This includes implementation of the Federal Order to limit spread of the disease, coordinating with federal partners to share expertise and lab capacity, doubling down on our work with producers to practice good biosecurity measures, continuing to conduct investigations to determine how the virus is spread within and between farms, and analyzing and sharing sequences alongside validated epidemiological information.

The U.S. government is addressing this situation with urgency and through a whole-of- government approach. USDA is working closely with federal partners at FDA, which has the primary responsibility for the safety of milk and dairy products, by assisting with conducting lab testing at USDA labs. USDA is also working closely with federal partners at CDC, which has the primary responsibility for public health, by encouraging producer and industry cooperation with public health officials to get vital information necessary to assess the level of risk to human health.

Additional details on how producers can access and apply for the financial tools is forthcoming.

HHS

Today, HHS announced new funding investments through CDC and FDA totaling $101 million to mitigate the risk of H5N1 and continue its work to test, prevent, and treat H5N1. Although the CDC’s assessment of the risk of avian influenza infection for the general public continues to remain low at this time, these investments reflect the Department’s commitment to prioritizing the health and safety of the American public.

Public and animal health experts and agencies have been preparing for avian influenza outbreak for 20 years. Our primary responsibility at HHS is to protect public health and the safety of the food supply, which is why we continue to approach the outbreak with urgency. We stood up a response team which includes four HHS agencies – CDC, FDA, NIH and ASPR – which are working closely with USDA to:

• Ensure we keep communities healthy, safe, and informed;
• Ensure that our Nation’s food supply remains safe;
• Safeguard American agriculture and the livelihood and well-being of American farmers and farmworkers; and
• Monitor any and all trends to mitigate risk and prevent the spread of H5N1 among both people and animals.

Some examples of this work include:

• CDC monitoring of the virus to detect any changes that may increase risk to people, and updated avian flu guidance for workers to ensure people who work with dairy cows and those who work in slaughterhouses have the guides and information they need in both English and Spanish.
• CDC's ongoing discussions with multiple states about field investigations and incentives for workers who participate in these on-site studies. CDC has also asked health departments to distribute existing PPE stocks to farm workers, prioritizing those who work with infected cows. To help states comply with CDC recommendations, ASPR has PPE in the Strategic National Stockpile (SNS) available for states to request if needed.
• FDA’s close coordination with USDA to conduct H5N1 retail milk and dairy sample testing from across the country to ensure the safety of the commercial pasteurized milk supply. NIAID – a part of NIH - is also providing scientific support to this entire effort through six U. S. based Centers for Excellence for Influenza Research and Response, known as CEIRRs.

Today, in light of HHS’ ongoing commitment to ensure the safety of the American people and food supply, HHS announced additional resources to further these efforts through CDC and FDA:

CDC announced it has identified an additional $93 million to support its current response efforts for avian influenza. Building on bipartisan investments in public health, this funding will allow CDC to capitalize on the influenza foundation that has been laid over the last two decades, specifically where CDC has worked domestically and globally to prevent, detect, and respond to avian influenza.

These investments will allow CDC to bolster testing and laboratory capacity, surveillance, genomic sequencing, support jurisdictions and partner efforts to reach high risk populations and initiate a new wastewater surveillance pilot.

• $34 million in Testing and Laboratory Capacity to:
  • Develop and optimize assays that can be used to sequence virus independent of virus identification.
  • Assess circulating H5N1 viruses for any concerning viral changes, including increased transmissibility or severity in humans or decreasing efficacy of diagnostics or antivirals.
  • Support the ability of STLT Public Health Labs throughout the country to surge their testing abilities, including support for the additional costs of shipping human avian influenza specimens, which are select agents.
  • Through the International Reagent Resource (IRR), support manufacture, storage, and distribution of roughly one thousand additional influenza diagnostic test kits (equaling nearly around one million additional tests) for virologic surveillance. The IRR would also provide influenza reagents for research and development activities on a global scale. This is in addition to current influenza testing capacity at CDC and in STLT public health and DOD labs, which is approximately 490,000 H5-specific tests.
  • Address the manufacturer issue detected with current avian flu test kits.
  • Initiate avian flu testing in one commercial laboratory.

• $29 million in Epidemiology, Surveillance, and Data Analytics to:
  • Scale up existing efforts to monitor people who are exposed to infected birds and poultry to accommodate workers at likely many more poultry facilities, as well as potentially workers at other agricultural facilities and other people (e.g., hunters) who may be exposed to species that pose a threat.
  • Scale up contact tracing efforts and data reporting to accommodate monitoring of contacts of additional sporadic cases.
  • Support the collection and characterization of additional clinical specimens through established surveillance systems from regions with large numbers of exposed persons to enhance the ability to detect any unrecognized cases in the community if they occur.
  • Expand respiratory virus surveillance to capture more samples from persons with acute respiratory illness in different care settings.
  • Support continuation and possible expansion of existing respiratory surveillance platforms and vaccine effectiveness platforms.
• $14 million in Genomic Sequencing to:
  • Provide bioinformatics and data analytics support for genomic sequencing at CDC that supports surveillance needs for enhanced monitoring.
  • Expand sequencing capacity for HPAI in state-level National Influenza Reference Centers (NIRCs), Influenza Sequencing Center (ISC), and Pathogen Genomic Centers of Excellence.
• $8 million in Vaccine Activities to:
  • Analyze circulating H5N1 viruses to determine whether current Candidate Vaccine Viruses (CVVs) would be effective and develop new ones if necessary.
• $5 million in STLT Jurisdiction/Partner Funding to:
  • Support partner efforts to reach high risk populations.
• $3 million in Wastewater Surveillance to:
  • Initiate wastewater pilot to evaluate the use case for HPAI in up to 10 livestock - adjacent sites in partnership with state and local public health agencies and utility partners.
  • Implement a study to evaluate the use of Influenza A sequencing in wastewater samples for highly pathogenic avian influenza typing. Initiate laboratory evaluation for HA typing and examine animal-specific markers in community wastewater to assess wildlife and livestock contribution and inform interpretation of wastewater data for action.

Additionally, the FDA is announcing an additional $8 million is being made available to support its ongoing response activities to ensure the safety of the commercial milk supply. This funding will support the agency’s ability to validate pasteurization criteria, conduct surveillance at different points in the milk production system, bolster laboratory capacity and provide needed resources to train staff on biosecurity procedures. Additionally, these funds will help support H5N1 activities in partnership with state co-regulatory partners, who administer state programs as part of the federal/state milk safety system. It may also allow the FDA to partner with universities on critical research questions.