WASHINGTON—U.S. Senator Mitt Romney (R-UT), member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, today sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, U.S. Department of Agriculture (USDA) Secretary Tom Vilsack, and U.S. Centers for Disease Control and Prevention (CDC) Director Mandy Cohen raising concern with the agencies’ inaction to understand and contain the outbreak of the bird flu virus (H5N1)—especially given the lessons learned from the COVID-19 pandemic and recent baby formula shortage. In the letter, Romney calls on the agency heads to work swiftly to fill existing gaps in public health knowledge and quickly disseminate accurate information to reassure the American public that they remain safe.

“I am alarmed by reports about the rapid spread of the bird flu virus (H5N1), and concerned that your agencies are not moving quickly enough to understand and contain the outbreak. It is critical that you work swiftly to get ahead of this emerging situation and reassure the American public that they—and our food supply—remain safe,” Senator Romney wrote. “Given your agencies’ recent experience with the COVID-19 pandemic and baby formula shortage, I am concerned that once again our federal government and its interagency process appears to be caught flat-footed.”

“The responsibility of protecting American consumers and livestock from threats like bird flu is a joint effort between the USDA, the FDA, and the CDC,” Romney continued. “Critical questions remain unanswered regarding the transmission and spread of the virus, requirements for testing livestock, and the safety of our milk and beef supply in the United States.”

The full text of the letter can be found below.

Dear Commissioner Califf, Secretary Vilsack, and Director Cohen:

I am alarmed by reports about the rapid spread of the bird flu virus (H5N1), and concerned that your agencies are not moving quickly enough to understand and contain the outbreak. It is critical that you work swiftly to get ahead of this emerging situation and reassure the American public that they – and our food supply – remain safe. Given your agencies’ recent experience with the COVID-19 pandemic and baby formula shortage, I am concerned that once again our federal government and its interagency process appears to be caught flat-footed.

On March 25, 2024 the United States Department of Agriculture (USDA) confirmed the first case of H5N1 in dairy cattle. Subsequently, on April 1, 2024, the Centers for Disease Control and Prevention (CDC) confirmed the second-ever human case of this strain in the United States. Thankfully, cases of human-to-human transmission have not yet been reported. But, I am concerned by the FDA’s recent report that one in five samples of milk now contains fragments of the virus.

The responsibility of protecting American consumers and livestock from threats like bird flu is a joint effort between the USDA, the Food and Drug Administration (FDA), and the CDC. Critical questions remain unanswered regarding the transmission and spread of the virus, requirements for testing livestock, and the safety of our milk and beef supply in the United States.

It is essential that you move to fill the existing gaps in our public health knowledge by conducting sound science and quickly disseminating accurate information. Please submit your agency’s responses to the following questions as soon as possible, and no later than May 10, 2024.

1. What specific steps are your agencies currently taking to contain the bird flu outbreak and ensure it does not spread further among humans?
2. Are your agencies confident that the commercial milk and beef supply is safe for consumption? If not, what additional testing is necessary to confirm that this is the case and when will that testing be completed?
3. What risks do the high levels of inactivated virus found in milk pose to humans? Could the virus be reactivated?
4. USDA is currently only mandating testing in lactating cattle prior to interstate transport.

1. 1. Why has USDA limited testing only prior to interstate transport?
   2. What percentage of dairy cattle are not transported across state lines? Are the current testing requirements missing a critical percentage of infected cattle and allowing the outbreak to spread?
   3. USDA announced that it is testing beef samples, but only in states with confirmed outbreaks. Given confirmed asymptomatic infections and other indications that the outbreak may be more widespread than we know, why is USDA not rapidly testing beef in all 50 states?

1. Are USDA, FDA, and CDC conducting proactive, joint surveillance and sharing information across agencies to proactively detect unusual bird flu activity in wild animals, livestock, or humans? Are there federal programs, like the CDC’s National Wastewater Surveillance System (NWSS), that are tracking or have the capacity to track existing and emerging infectious diseases on farms? 
2. What steps are you taking to proactively inform and protect agricultural frontline workers on H5N1 precautionary measures, actions needed in the case of an exposure, and symptoms?
3. Federal researchers have identified a genetic mutation in a recently confirmed case of bird flu in a dairy cow that suggests the current strain of H5N1 in the U.S. has adapted to spread better in mammals.

1. 1. Which federal agencies are currently conducting assessments on the capability of H5N1 to continue mutating and present increased risk to humans?
   2. Are studies being conducted on the likelihood of genetic adaptation that allows for human-to-human transmission?