On Tuesday, Booker sent a letter to commissioner Robert Califf expressing concerns about changes to “duration limits” in the FDA’s revised guidance on antibiotic use in animal agriculture. Continuously using drugs for long stretches is known to lead to antibiotic resistance. And just as antibiotics are now prescribed for humans for the least number of days possible, the FDA has long recognized the need to set limits in feeding them to groups of pigs, chickens, and cows.

However, in the proposal, Booker said, agency officials went in the other direction and eliminated a 21-day limit for the most critical drugs, replacing it with guidelines that allow courses to be determined on a case-by case-basis. “This will set a dangerous precedent by prioritizing the needs of the regulated industry over the FDA’s primary mission to protect public health,” Booker said. “I urge you to finalize Guidance for Industry that meaningfully protects medically important antibiotics from overuse.”

Antibiotic resistance is a looming public health threat that already directly causes the deaths of 1.27 million people (and contributes to the deaths of 5 million) globally each year. Overuse of important drugs (i.e., those that are also used to treat infections in humans, usually referred to as “medically important”) on industrial farms is a key contributor to the problem. As a result, a draft of a United Nations declaration expected to be finalized this September calls for completely ending the routine use of essential drugs in agriculture aside from the treatment of sick animals.

The meat industry in Europe has already taken significant steps toward that goal, but some of the biggest companies in the U.S. have recently been backtracking. Last week, less than a year after Tyson made a U-turn on its decision to eliminate antibiotics in its chicken production, Bloomberg reported the company is also cutting its antibiotic-free beef offerings.

While the overall volume of medically important antibiotics sold for animals is still down compared to a high in 2015, it has been rising in both pork and beef production over the past two years. The FDA is still not tracking exactly how those drugs are being used on farms. However, older U.S. Department of Agriculture data showed cattle feedlots routinely add antibiotics to feed for periods of several weeks or more to “prevent, control, or treat” disease. And in the most recent data collected, some pork producers reported using important drugs primarily for growth promotion, a practice that has been illegal since 2017. In that data, producers reported feeding chlortetracycline to nursery-aged pigs for an average of nearly 46 days.

Chlortetracycline is an active ingredient in several of the close to 100 important drugs approved for use in animal agriculture that still do not have defined duration limits. Since 2003, the FDA has required companies to define limits on how longs drugs can be used  as part of the approval process, but many drugs still used today were approved prior to that change.

In its 2019 goals for antibiotic stewardship, the agency said it would “work over the next several years to establish targeted durations of use, so that veterinarians have clear labeling indications and instructions on how long to use a medically important antimicrobial drug.”

But Booker’s letter claims that in revising the documents it publishes to set guidelines for the industry, the FDA is doing the opposite. Booker says the FDA previously required safety precautions for the use of some antibiotics—those most critical to human health—in animals, including limiting overall use to 21-day courses. These new revisions, he says, will replace that limit with directions that say “duration of use will be revised on a case-by-case basis in light of, but not limited to, animal species, disease risk period, and animal management husbandry practices, etc.”

“They’re really letting the industry decide how long [antibiotics] need to be used,” said Steven Roach, the Safe & Healthy Food Program Director at the Food Animal Concerns Trust (FACT). “Our biggest concern is they’re putting animal health ahead of human health.”

Roach is also a senior analyst for Keep Antibiotics Working, a coalition of public health and environmental groups that fights to prevent the development of antibiotic-resistant “superbugs.” In March, a group of organizations in the coalition—including FACT, the Antibiotic Resistance Action Center at George Washington University, and the Center for Food Safety—sent a letter to the FDA laying out many of these same concerns. Booker’s letter amplifies their message.

In response to a request for comment, the FDA directed Civil Eats to a previous response to the Keep Antibiotics Working letter, in which the agency disputed the group’s characterization of FDA eliminating the 21-day duration limit in its revised guidance. “Twenty-one days is not intended to be interpreted as a standard maximum duration,” the agency wrote. The new language, it said, “was added to address the varying differences across animal production systems, and does not change the qualitative risk rankings . . . nor does it limit the Agency from considering additional use restrictions.”

Booker’s letter, however, lays out more specific questions for the agency to respond to—and many of the questions read like he’s looking for answers that could inform Congressional action. For example, he asks whether the agency feels it lacks the authority to suggest drug makers adopt a 21-day duration limit, something Congress could grant through legislation. He also asks what might enable the agency to take more definitive action to curb antibiotic overuse on farms.

“Given the slow pace of action to address the critical public health threat of antibiotic resistance, what additional resources or authorities does the FDA need to take prompt action to protect public health from antibiotic resistance?” he writes.

Of course, regulating animal agriculture is not a popular issue in Washington, D.C., and the current political climate makes it difficult for lawmakers to move any legislation. “Congress could pass legislation that would do this, but that’s really hard to get done right now,” Roach said. “But I think having them ask questions is helpful. Any pressure on them from Congress to do what’s right is helpful.”

Read More:
Medically Important Antibiotics Are Still Being Used to Fatten Up Pigs
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The FDA Is Still Not Tracking How Farms Use Antibiotics

Bye-bye to BVO. Last week, the FDA took definitive action on another front when it declared that brominated vegetable oil (BVO), an ingredient used in soda and other drinks to prevent liquids from separating, is no longer considered safe, effectively removing it from the food supply starting in August. Public health experts have been sounding alarms about the ingredient’s potential health risks for years, which prompted industry leaders—including PepsiCo and Coca-Cola—to remove BVO from their products in advance of the law changing. California also banned the manufacturing, distribution, and sale of foods and beverages containing BVO last year. But hundreds of drinks sold by major retailers may still contain the ingredient. “The FDA’s decision to ban brominated vegetable oil in food is a victory for public health. But it’s disgraceful that it took decades of regulatory inaction to protect consumers from this dangerous chemical,” said Scott Faber, senior vice president of government affairs at the Environmental Working Group, in a press release.

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Historic Heat Protections. During a week when soaring temperatures threatened the health and safety of individuals in cities all over the country, the Occupational Safety and Health Administration (OSHA) proposed the first federal rule intended to protect workers from injury and illness caused by extreme heat. If finalized, the rule will require employers to evaluate heat risks, develop plans to control heat hazards, and implement solutions such as providing drinking water and rest breaks when heat is a threat.

While it applies to all industries, the rule has major implications for farmworkers, who die of heat-related causes at a rate that is 20 times higher than in other professions. As climate change intensifies heat conditions, some states have passed laws requiring farm operators to provide field workers with protections including shade, water, and breaks, while others have banned local laws that would protect farmworkers from heat.

“This is a bittersweet moment for farmworkers. Every significant heat safety regulation in America at the state, and now federal, level was written in the blood of farm workers,” said United Farm Workers president Teresa Romero in a press release. “Today, the federal government put itself on the right side of history by seeking, for the first time, to establish the precedent that every worker in America has the right to shade, water, and rest while working in temperatures that could kill them.”

Last year, 112 Democrats in the House and Senate called for the Biden administration to implement a workplace heat standard. OSHA has yet to publish the rule in the Federal Register. Once it is published, a public comment period will follow before the rule is finalized. Industry groups will likely mobilize to halt or weaken it, and a Trump administration would likely prevent the rule from being finalized.

Read More:
As the Climate Emergency Grows, Farmworkers Lack Protection from Deadly Heat
Florida Banned Farmworker Heat Protections. A Groundbreaking Partnership Offers a Solution.
Nighttime Harvest Protect Farmworkers From Extreme Heat, but Bring Other Risks