Antibiotic legislation in the works, again

Oct 26, 2012

Energy and Commerce Committee Ranking Member Henry A. Waxman announced plans to introduce legislation that would increase information required on the amount and use of antibiotics in animals raised for human consumption. The bill, the “Delivering Antibiotic Transparency in Animals (DATA) Act,” will provide critical information to the Food and Drug Administration (FDA) about the amounts and types of antibiotics being fed to livestock, according to Waxman.

Rep. Waxman made the announcement at a press conference in Santa Monica where he was joined by supporters.

“We need reliable information about the use of antibiotics in agricultural operations,” said Waxman.

“The more we learn, the graver the threat becomes from overuse of antibiotics by industrial-scale farms. We need this information so scientists and Congress can stop the spread of drug-resistant infections from farm animals to humans.” Waxman has joined Rep. Louise Slaughter, D-NY, in trying to eliminate the use of antibiotics in agriculture, with claims that agriculture use is the root cause of resistance in humans.

If passed, the bill would require drug manufacturers to provide comprehensive information to FDA on how their drugs are used on farms. The legislation will also require reporting by feed mills for the first time. The bill would require feed mills to submit data to FDA on the types, purposes, and quantities of antibiotics being given to animals through feed.

According to a Waxman release, virtually all antibiotic consumption on farms comes through feeds mixed with antibiotics.

The American Feed Industry Association said the bill is a retread of failed legislation and that if enacted, would be expensive, time-consuming, yield little new information, and possibly require feed mills to release customer information.

The bill was praised by Consumers Union, which last month delivered a petition to the agency signed by half a million people. The group also claims that overuse of antibiotics by the agriculture industry has made antibotics less effective in humans.

Last June, they campaigned against antibiotic use, trying to persuade grocery stores to carry only meat raised without antibiotics.

An accompanying report during their crusade, “Meat On Drugs: The Overuse of Antibiotics in Food Animals and What Supermarkets and Consumers Can Do to Stop It,” found that 72 percent of survey respondents were “extremely or very concerned about the overuse of antibiotics in animal feed.”

Jean Halloran, director of food policy initiatives with the Consumers Union, joined Waxman during his announcement.

Halloran said in a press statement that the legislation will show the extent to which antibiotics are overused on the farm, and allow FDA to take appropriate action.

“The daily feeding of antibiotics to healthy farm animals threatens public health by making these critical medications less effective for people,” she said.

“We need to limit the excessive use of antibiotics in animal feed if we are going to prevent them from losing their power for people.”

In addition to the feed mill reporting requirements, drug makers would be required to provide more than the total sales data now reported. The companies are not required to break the data down by species or distinguish which drugs were used in food-producing animals. The reporting would only affect drugs used in food animals, and would exclude horses and pets.

FDA’s Center for Veterinary Medicine is pursuing a voluntary industry collaborative approach, and intends to eliminate exclusive label claims for growth promotion/feed efficiency, opting instead to limit those uses within a new definition of “prevention” and tying all use to an expanded Veterinary Feed Directive program.

The legislation has also received the support of the Pew Health Group, a public health advocacy group. According to the group, the bill could assist the public and industry in figuring out if FDA’s recent changes are working.

“In April, the FDA issued draft voluntary guidance to limit the overuse and misuse of antibiotics,” wrote Laura Rogers, project director for the Pew Campaign on Human Health and Industrial Farming. “Rep. Henry Waxman’s, D-CA, proposed legislation would enable the FDA and the public to verify whether the agency’s efforts are actually working.”

But producers stand by the science behind antibiotic use, which shows the system is working.

Antibiotics used in beef cattle production must go through a rigorous testing process before being approved by FDA. The Center for Veterinary Medicine (CVM), a branch of FDA, is responsible for ensuring that animal drugs are safe, effective, and manufactured to the highest quality standards. While there are many aspects that go into the animal antibiotic approval process, human safety is a key component. Withdrawal times are established as part of the approval process to specify the number of days that must pass between the last antibiotic treatment and before the animal can enter the food supply. This ensures that an antibiotic has sufficiently cleared an animal’s system. By law, any person administering antibiotics to livestock must follow withdrawal periods.

Additionally, FDA and USDA have a coordinated surveillance program to monitor for antibiotic residues.

In July 2012, FDA introduced an advanced notice of public rulemaking to require manufacturers to provide more data on the use of antibiotics in animals. The introduction of that rule was delayed in September 2012 after FDA said it was extending the public comment period in order to collect additional comments. Comments will be taken until Nov. 26, 2012, at http://www.

Through this Advance Notice of Proposed Rulemaking, FDA is soliciting public comment on:

• Whether FDA should amend its regulations to require the submission of additional sales and distribution information. Specifically, for drug products that are approved and labeled for more than one food-producing animal species, how sponsors can both practically and accurately provide separate sales and distribution information for each species on the label.

• How FDA can best compile and present the annual summary information, while still protecting confidential business information as directed by statute.

• Alternative methods available to FDA within its existing authority for obtaining additional data and information about the extent of antimicrobial drug use in food-producing animals to further support the analysis of factors related to the development and spread of antimicrobial resistance in connection with the use of medically important antibiotics in food-producing animals. — Traci Eatherton, WLJ Editor

Safe use of antibiotics in cattle

The Beef Quality Assurance (BQA) program has been training beef producers about the safe and appropriate use of antibiotics since the 1980s. The National Cattlemen’s Beef Association Producer Guidelines for “Judicious Use of Antimicrobials” have been in place since 1987 and specifically outline the appropriate use of these products:

• Avoid using antibiotics that are important in human medicine.

• Use a narrow spectrum of antimicrobials whenever possible.

• Treat the fewest number of animals possible.

• Antibiotic use should be limited to prevent or control disease and should not be used if the primary intent is to improve performance.