The U.S. Food and Drug Administration (FDA) said the antibiotics could still be used to treat illnesses in animals raised for meat, but should otherwise be pared back over the next three years under a voluntary program to keep them out of the human food supply.

Although voluntary, the agency said it expects drugmakers to fully adhere to the new guidelines and on Wednesday announced that two of these biggest purveyors of those antibiotics had already agreed to narrow their use.

Doctors and hospitals have become increasingly worried in recent years by new strains of bacteria that cannot be controlled by a wide range of current antibiotics. Part of the suspected reason for the emergence of these “superbugs” is that people who have eaten meat that contained antibiotics develop resistance to the drugs as bacteria mutate to thwart them.

“Because antimicrobial drug use in both humans and animals can contribute to the development of antimicrobial resistance, it is important to use these drugs only when medically necessary,” the FDA said in a release.

In guidance issued Wednesday, the FDA asked global drugmakers and animal health companies including Eli Lilly and Zoetis to revise labels of medically important antibiotics by removing references to use in animal production.

Once companies remove farm production uses of their antibiotics from drug labels, it would become illegal for those drugs to be used for those purposes, deputy FDA commissioner Michael Taylor said in a conference call with journalists. The agency said about 25 animal health companies could be affected by the guidelines, especially Lilly and Zoetis.

Although the program is meant to be voluntary, Taylor said the FDA would be able to take regulatory action against companies that fail to comply.

The FDA’s “final guidance,” also brings the drugs under oversight of veterinarians by changing the over-the-counter status of the products.

The FDA said it will require animal pharmaceutical companies to notify the agency within three months of their intent to adopt its strategy. The companies would then have three years to complete the transition process.

Critics question enforcement

Critics on Wednesday said the guidelines give drugmakers too much discretion in policing their own use of antibiotics.

Democratic lawmaker Louise Slaughter called the FDA move an inadequate response to the overuse of antibiotics “with no mechanism for enforcement and no metric for success.”

Her view was echoed by consumer and environmental advocacy groups.

“Our fear… is that there will be no reduction in antibiotic use as companies will either ignore the plan altogether or simply switch from using antibiotics for routine growth promotion to using the same antibiotics for routine disease prevention,” said Steven Roach, senior analyst with advocacy group Keep Antibiotics Working.

Morningstar analyst David Krempa said the FDA issued similar voluntary guidelines in April 2012, meant to limit use of important antibiotics in food-producing animals, but they appear to have been largely ignored by farmers.

He said compliance with the FDA’s latest set of voluntary guidelines could be equally spotty.

“Compliance will be tough because all the farmers and meat producers know these products increase the size of their animals,” Krempa said. “They can continue to use them, and just say there’s a disease going through their herds.”

But even if antibiotics use in livestock indeed comes down, Krempa said it would be only a “small negative” for Zoetis because it, like other animal health companies, sells such a wide range of products for both livestock and pets.

The FDA said it had already received support for the new measures from Zoetis and Elanco, a unit of Eli Lilly, which sell a large percentage of the products that will eventually be phased out.

Elanco said in a statement that it would voluntarily narrow use of antibiotics used to treat both humans and animals “only to therapeutic purposes of treating, controlling and preventing diseases in animals under the supervision of a veterinarian.”

Other companies with animal health businesses include Merck, Novartis, Sanofi and Bayer.

Bayer and Sanofi said the FDA strategy would not affect the types of products they sell, but both companies said they support the FDA’s position.

“It is important that these medically important antibiotics are used responsibly and with veterinary oversight,” a Bayer spokeswoman said.

— Ransdell Pierson and Charles Abbott report for Reuters on the pharmaceutical industry from New York City and on U.S. agricultural policy from Washington, D.C. respectively.

Related stories:
Panel raps lack of action to curb drug use in U.S. livestock, Oct. 22, 2013
Ont. docs seek ban on antibiotic use in livestock gain, March 22, 2013

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“Meaningful change is unlikely in the future,” concluded the 14-member panel, assembled by Johns Hopkins University, in a report released on Tuesday.

The release marked the fifth anniversary of a landmark 2008 Pew Charitable Trust report that called for an end to the sub-therapeutic use of antibiotics by livestock producers, as well as an end to practices such as tiny cages for laying hens.

Congressional hearings followed the release of that report, and the livestock industry went into damage-control mode.

Antibiotics are routinely sprinkled into U.S. cattle, hog and poultry feed, not only to prevent and treat illness but to promote growth. Agriculture accounts for 80 per cent of antibiotic sales, according to the limited records available.

The Johns Hopkins’ report said “additional scientific evidence has strengthened the case that these (non-therapeutic) uses pose unnecessary and unreasonable public health risks” of allowing bacteria to develop resistance to antibiotics.

“There has been an appalling lack of progress,” said director Robert Lawrence of the Johns Hopkins Center for a Livable Future, which produced the report. He said lack of action by Congress and federal regulators and the “intransigence of animal agriculture industry” had made the problems worse.

The panel that wrote the Johns Hopkins report included ranchers, public health experts, the former dean of a veterinary school and former U.S. agriculture secretary Dan Glickman. Its chairman was former Kansas governor John Carlin.

While the U.S. Food and Drug Administration has altered its guidelines to say antibiotics should be used only under the guidance of a veterinarian for prevention, control or treatment of disease, the Johns Hopkins report said there was a loophole. Drugs can be approved for disease prevention on the proviso that they are not being used as part of livestock production.

“This means that while antimicrobial approvals may change… antimicrobial use may not,” said the report.

An FDA spokesman was not immediately available for comment.

A livestock group, the Animal Agriculture Alliance, said in its own report — released to coincide with the Johns Hopkins study — that the FDA guidelines will assure medically important antibiotics are used by farmers and ranchers only to combat disease.

Richard Raymond, a former agriculture undersecretary for food safety, said in the alliance report that antibiotics are part of an array of biological tools for livestock producers.

Raymond listed them along with beta-agonists, a type of feed additive that helps animals gain weight faster, and man-made bovine hormones which are used to boost dairy production.

U.S. drugmaker Merck & Co. suspended U.S. and Canadian sales of Zilmax, the leading beta-agonist, on Aug. 16 following concerns about cattle who appeared to be sore footed or were having difficulty walking after being fed the additive.

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Four hours of face-to-face meetings on Wednesday and Thursday failed to produce an agreement. House agriculture chairman Frank Lucas told reporters on Thursday that no more meetings were planned this week.

Congress plans only a couple of weeks of work in December before adjourning for the year. Without an agreement soon among negotiators, it will be impossible to call a vote before year-end on the $500 billion, five-year legislative package.

The Republican-controlled House of Representatives wants the biggest cuts in a generation in food stamps for the poor, $39 billion over 10 years (all figures US$). That’s nearly 10 times the proposal from the Democrat-run Senate.

“It’s all about policy,” Senate agriculture chairwoman Debbie Stabenow told reporters outside her basement “hideaway” office in the Capitol, where talks were held.

Stabenow was unyielding on food stamps, saying harmful cuts were unacceptable. She also was not willing to consider cuts of $10 billion as a lure to gain support from conservative House Republicans, who have demanded sweeping cuts.

“They’re not the people who are going to vote for the Farm Bill anyway,” said the Michigan Democrat.

Analysts say it will be difficult to write a food stamp section acceptable to all sides. Some conservative Republicans want still deeper cuts while a large number of House Democrats oppose any cuts at all.

The White House has threatened twice to veto a farm bill with unduly harsh cutbacks in food stamps.

“The commodity title and SNAP (food stamps) are the two issues,” said Rep. Colin Peterson, the Democratic leader on the House agriculture committee.

Dairy cliff

Without a new law, the U.S. farm program will revert on Jan. 1 to the high support prices of an underlying 1949 law. The price of milk in the grocery store would double, creating the so-called dairy cliff.

Lawmakers averted that threat a year go by passing a short-term extension, now expired, of the 2008 farm law.

“There won’t be an extension in the Senate that includes direct payments,” said Stabenow, referring to the $5 billion-a-year subsidy to grain, cotton and soybean farmers that is a top target of reformers.

Asked about bundling a farm bill with a deficit reduction package, Stabenow said, “I’ve always said I’m open to many things.” House Speaker John Boehner ruled out that tactic last week, saying the farm and budget bills are separate matters.

Besides food stamps, there are disputes over crop and dairy subsidies. The Senate says the House would set target prices so high they would override the marketplace and the House says the new revenue protection system supported by the Senate is skewed toward the corn and soybean growers in the Midwest while putting those who grow wheat, rice and peanuts at a disadvantage.

House majority leader Eric Cantor spearheaded the plan for sweeping change to food stamps, formally named the Supplemental Nutrition Assistance Program (SNAP). With nearly one in seven Americans currently receiving aid, Cantor said the program was an unaffordable burden on middle-class Americans.

On Nov. 1 SNAP recipients saw a $5 billion cut in benefits, or roughly seven per cent per person, when part of the 2009 economic stimulus package expired.

The Center on Budget and Policy Priorities, a think tank, said this week that SNAP enrollment rose because of the 2008-09 recession and high jobless rates.

It said food stamp costs are certain to fall during 2014 and warned that additional large cuts “would make life harder for tens of millions of Americans.”

— Charles Abbott is a Reuters correspondent covering U.S. farm, agrifood and ag trade policy from Washington, D.C.

Related story:
U.S. farm law expires again with lawmakers split on new bill, Oct. 2, 2013

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“Meaningful change is unlikely in the future,” concluded the 14-member panel, assembled by Johns Hopkins University, in a report released on Tuesday.

The release marked the fifth anniversary of a landmark 2008 Pew Charitable Trust report that called for an end to the sub-therapeutic use of antibiotics by livestock producers, as well as an end to practices such as tiny cages for laying hens.

Congressional hearings followed the release of that report, and the livestock industry went into damage-control mode.

Antibiotics are routinely sprinkled into U.S. cattle, hog and poultry feed, not only to prevent and treat illness but to promote growth. Agriculture accounts for 80 per cent of antibiotic sales, according to the limited records available.

The Johns Hopkins’ report said “additional scientific evidence has strengthened the case that these (non-therapeutic) uses pose unnecessary and unreasonable public health risks” of allowing bacteria to develop resistance to antibiotics.

“There has been an appalling lack of progress,” said director Robert Lawrence of the Johns Hopkins Center for a Livable Future, which produced the report. He said lack of action by Congress and federal regulators and the “intransigence of animal agriculture industry” had made the problems worse.

The panel that wrote the Johns Hopkins report included ranchers, public health experts, the former dean of a veterinary school and former U.S. Agriculture Secretary Dan Glickman. Its chairman was former Kansas Governor John Carlin.

While the U.S. Food and Drug Administration has altered its guidelines to say antibiotics should be used only under the guidance of a veterinarian for prevention, control or treatment of disease, the Johns Hopkins report said there was a loophole. Drugs can be approved for disease prevention on the proviso that they are not being used as part of livestock production.

“This means that while antimicrobial approvals may change… antimicrobial use may not,” said the report.

An FDA spokesman was not immediately available for comment.

A livestock group, the Animal Agriculture Alliance, said in its own report — released to coincide with the Johns Hopkins study — that the FDA guidelines will assure medically important antibiotics are used by farmers and ranchers only to combat disease.

Richard Raymond, a former agriculture undersecretary for food safety, said in the alliance report that antibiotics are part of an array of biological tools for livestock producers.

Raymond listed them along with beta-agonists, a type of feed additive that helps animals gain weight faster, and man-made bovine hormones which are used to boost dairy production.

U.S. drugmaker Merck & Co. suspended U.S. and Canadian sales of Zilmax, the leading beta-agonist, on Aug. 16 following concerns about cattle who appeared to be sore-footed or were having difficulty walking after being fed the additive.

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Cancellation of the October report means the first harvest-time estimate of U.S. crops will be Nov. 8. The production report and companion data on crops worldwide are the U.S. Agriculture Department’s premiere reports. They attract a worldwide audience and frequently affect commodity prices.

The cancellations will result in a two-month gap from USDA’s previous estimates, issued on Sept. 12, until the update set for Nov. 8.

USDA announced the cancellations as the government returned to work after a 17-day shutdown due to lack of funding. Agriculture Secretary Tom Vilsack greeted employees as they entered the USDA complex on the national Mall. “Good to have you back,” he said.

“While the lapse in federal funding has ended, NASS has not been able to engage in the necessary data collection and analysis over the past few weeks,” said USDA, referring to its National Agricultural Statistics Service, the agency that produces hundreds of reports yearly.

USDA usually spends three weeks in compiling data for the crop report, beginning with a two-week survey of growers and spot-checks of yields on hundreds of plots nationwide.

The last time USDA delayed its premiere reports was September 2001, when they were delayed by two days in the wake of the Sept. 11 terror attacks. The reports were delayed occasionally due to heavy snowstorms.

Officials checked records into the early 1970s without finding an occasion when the crop report was not issued at all.

Besides the crop report and the companion World Agricultural Supply and Demand Estimates (WASDE) report, USDA said it cancelled two weekly reports on crop conditions. It said a monthly Cattle on Feed report, due on Friday, was postponed, along with a report on peanut prices.

“NASS is assessing its data collection plans and evaluating the timing of upcoming reports,” said USDA.

Officials met to decide what to do about USDA’s weekly report of grain, soybean and cotton exports, a report that also is an important indicator of activity for the world’s largest agricultural exporter.

The weeks-long process of collecting data for the monthly U.S. crop production report was about half finished when USDA’s army of some 3,400 crop scouts was furloughed on Oct. 1.

USDA contacts about 14,400 farmers as part of estimating U.S. corn, soybean, cotton and other crops — mostly by telephone but also by mail, Internet, and face-to-face meetings — for the October report.

Work on the scheduled Nov. 8 crop report would typically start about a week from now.

Agricultural markets have been flying partially blind since the daily gusher of reports from USDA was shut off on Oct. 1.

“I’m on pins and needles waiting to hear” the fate of the reports, one cotton analyst said on Thursday.

— Charles Abbott is a Reuters correspondent covering U.S. farm, agrifood and ag trade policy from Washington, D.C.

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The bill is also expected to cut funding for conservation programs but expand by $1 billion a year the federally subsidized crop insurance program, which now costs around $9 billion annually (all figures US$).

“Depending on the House and Senate schedules, the first, formal conference meeting could be scheduled as early as next week,” said an aide to House agriculture committee chairman Frank Lucas. Under congressional protocol, Lucas will chair the conference committee formed to write a compromise bill between the House and Senate versions.

If Congress is not in session next week, the negotiators may not meet until the following week, said two other congressional staff workers.

The first meeting of House and Senate conferees is a milestone that marks the final round of work on major legislation. Commonly, a final version emerges within a few weeks.

Lucas says he is confident of consensus on a five-year bill.

Analysts said it will be difficult to reconcile the dramatically different proposals for food stamps.

House majority leader Eric Cantor of Virginia spearheaded the Republican drive to tighten eligibility rules for food stamps, ending benefits to nearly four million people in 2014, and save $39 billion over 10 years. His targeted cuts are nearly 10 times the amount proposed by the Democrat-run Senate, which focused on closing loopholes on utility costs.

The Republican-controlled House defeated its initial version of the farm bill, with $20 billion in food stamp cuts, because the cuts were too small to satisfy Tea Party-influenced conservatives. Democrats voted solidly against the cuts.

By comparison, disagreements over agricultural programs appear easier to resolve, although some are lightning rod issues.

The Senate, for example, would require farmers to practice conservation to qualify for premium subsidies on crop insurance and would reduce the subsidy for growers with more than $750,000 adjusted gross income a year. Both ideas are anathema to Lucas.

The Senate backs stricter limits on who can collect farm subsidies and how much they can get per year. And it says the support prices in the House bill are so high they might result in farmers aiming for a subsidy payment rather than a profit in the marketplace.

Rice and peanut growers say the Senate bill is skewed in favour of corn and soybean growers in the Midwest and that they get a fairer deal in the House bill.

An expanded and stronger crop insurance program was the top goal of farm groups in the bill. The House and Senate bills would do that through a “supplemental coverage option” that is an insurance policy covering up to 90 percent of normal revenue from grains and oilseeds.

Cotton growers would get their a revenue insurance program intended to resolve a World Trade Organization ruling against the U.S. subsidies now in place.

Brazil brought the WTO case against the U.S. a decade ago and has not said if the new scheme is satisfactory.

— Charles Abbott is a Reuters correspondent covering U.S. farm, agrifood and ag trade policy from Washington, D.C.

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Analysts say Congress is more likely to revive the farm law for another year or two, the path it took when the law expired a year ago, than agree on a new bill.

“They don’t even have the process in place to get it done,” Agriculture Secretary Tom Vilsack said in a speech Oct. 1 to United Fresh, a trade group for produce growers and processors.

The Democratic-run Senate has proposed $4.5 billion in loophole closing for food stamps. The Republican-controlled House wants to cut $40 billion over 10 years through tighter eligibility rules that would disqualify four million people.

With expiration, the Agriculture Department lost authority to run agricultural export, global food aid, livestock disaster relief and some conservation programs. Crop subsidies, crop insurance and food stamps, the big-ticket programs, are permanently authorized and remain in business.

Congress took two procedural steps in the past four days toward negotiations on a final version of the Farm Bill, but the Republican-controlled House must name its negotiators before talks can begin.

The new five-year Farm Bill could cost $500 billion with food stamps accounting for three-quarters of the spending.

On Oct. 1, the Senate formally asked the House for a “conference” on the farm bill and appointed the same 12 negotiators it named in August. The reappointments were necessary because the House merged separate farm subsidy and food stamp bills into one bill over the weekend.

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The non-binding House vote late on Friday will be a factor in upcoming negotiations with the Senate on a final version of the new farm bill, which is a year overdue. Senators put a similar restriction on farmers with more than $750,000 adjusted gross income (AGI) a year in their bill (all figures US$).

One per cent of farmers, or about 20,000 people, would be affected by the provision, estimated to save $1.3 billion over 10 years. Crop insurance is the costliest part of the farm safety net. The farm bill would expand the program by up to 10 per cent while cutting conservation and food stamps for the poor.

Farm bill negotiations were expected to begin soon, although no date was set. The House named 29 of its members as its conferees on the $500 billion, five-year farm bill on Saturday. The Senate appointed its conferees weeks ago.

Farm bills, written every few years, fund crop subsidies, conservation, public nutrition, food aid, research, agricultural exports and rural economic development programs.

Crop insurance reform was the only farm bill “instruction” approved by the House during a series of votes that cleared the way to negotiations with the Senate. The “sense of the House” resolution, approved on a voice vote, is an indication of lawmaker sentiment but conferees are not bound by it.

To reform-minded groups, the House vote was a step to rein in subsidy spending and give a hand to family farmers. The Environmental Working Group (EWG), which wants more money for conservation, said the $750,000 AGI limit was a “modest” reform “to bring a measure of fairness to crop insurance subsidies.”

The National Sustainable Agriculture Coalition, a small-farm advocate, and EWG said growers also should be required to practice conservation to qualify for subsidized insurance. The small-farm group called for a cap on insurance payments to farmers and restricting the program to active farmers.

Crop insurance is the only farm program without payment or eligibility limits, said sponsors of the plan to reduce the premium subsidy by 15 percentage points for farmers with more than $750,000 AGI. At present, the government pays an average 62 cents of each $1 of the premium.

“Let’s not subsidize folks at the high end as much and let’s protect the family farmer,” budget committee chairman Paul Ryan, a Wisconsin Republican, said Friday.

Agriculture committee chairman Frank Lucas, an Oklahoma Republican, said higher premiums could drive away large operators and, with a smaller pool of participants, drive up costs for smaller operators.

Texas Republican Mike Conaway said the proposal “will punish success, will punish efficiency.”

Georgia Republican Tom Price, a Ryan ally, said four per cent of farmers get one-third of crop insurance benefits. “It just doesn’t make sense,” he said.

“In fact, it is ironic that there has been this attack on food stamps,” said Oregon Democrat Earl Blumenauer, “which has a lower percentage of abuse than the crop insurance program.”

— Charles Abbott is a Reuters correspondent covering U.S. farm, agrifood and ag trade policy from Washington, D.C.

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Analysts say Congress is more likely to revive the farm law for another year or two — the path it took when the law expired a year ago — than to agree on a new bill.

“They don’t even have the process in place to get it done,” Agriculture Secretary Tom Vilsack said in a speech on Tuesday to United Fresh, a trade group for produce growers and processors.

The Democratic-run Senate has proposed $4.5 billion in loophole-closing for food stamps (all figures US$). The Republican-controlled House wants to cut $40 billion over 10 years through tighter eligibility rules that would disqualify four million people.

With expiration, the U.S. Department of Agriculture lost authority to run agricultural export, global food aid, livestock disaster relief and some conservation programs. Crop subsidies, crop insurance and food stamps, the big-ticket programs, are permanently authorized and remain in business.

Congress took two procedural steps in the past four days toward negotiations on a final version of the farm bill, but the Republican-controlled House must name its negotiators before talks can begin.

The new five-year farm bill could cost $500 billion with food stamps accounting for three-quarters of the spending.

On Tuesday, the Senate formally asked the House for a “conference” on the farm bill and appointed the same 12 negotiators it named in August. The re-appointments were necessary because the House merged separate farm subsidy and food stamp bills into one bill over the weekend.

Named as Senate conferees were agriculture committee chairwoman Debbie Stabenow, Michigan Democrat, and Thad Cochran of Mississippi, the Republican leader on the panel.

Besides Stabenow, the Democratic conferees are Pat Leahy of Vermont, Tom Harkin of Iowa, Max Baucus of Montana, Sherrod Brown of Ohio, Amy Klobuchar of Minnesota and Michael Bennet of Colorado. Along with Cochran, the Republican conferees are Saxby Chambliss of Georgia, Pat Roberts of Kansas, John Boozman of Arkansas and John Hoeven of North Dakota.

Under congressional protocol, Frank Lucas, chairman of the House agriculture committee, would preside over the negotiations. A spokesman for House Speaker John Boehner said the issue of naming conferees was under discussion, but there were no final decisions so far.

— Charles Abbott reports on U.S. federal farm and food policy for Reuters from Washington, D.C.

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But inspections of meat are considered among essential services that will continue even if most workers are idled.

If the shutdown lasts more than two or three days, USDA may be forced to delay the release of its monthly crop estimates, due on Oct. 11, which often cause swings worth billions of dollars in the price of corn, soybeans, wheat and cotton.

“We are going to miss the October crop report, if they shut down too long,” said Dan Basse, president of AgResource Co. “If you don’t have the October crop report, that’s really the big one.”

USDA also reports large export sales — 100,000 tons or more of corn, soybeans or wheat to a single destination in one day — that often move markets. On Sept. 18 the agency reported 1.93 million tons of soybeans to China, the fifth-largest daily sale ever.

Also suspended would be dozens of lesser-known reports that provide a daily or weekly foundation for tracking crops, livestock and the farm sector — from cattle auctions in Amarillo, Texas, to dry edible bean prices in Wyoming.

The department’s public face, its website, will “go dark” and be linked to an informational page in the event of a shutdown, allowing no access to USDA data banks, a spokeswoman said on Monday.

“Timely updates to the website will stop, thus valuable electronic reports and material will not be available to agricultural community and the agriculture and consumer publics,” said an outline of USDA’s plans.

As one example, USDA planned to report on Monday on its last-gasp efforts to whittle down a mammoth sugar surplus. Processors could default on half a million tons of sugar loans backed by USDA on Tuesday but the forfeitures would not be reported until the government was back at work.

A portion of USDA’s 100,000 employees would remain on the job. Meat and poultry inspectors, the subject of a funding fight after automatic budget cuts endangered their work early this year, are designated as essential personnel.

Without them, the meatpacking industry would have to shut down because, by law, it cannot operate without USDA inspectors to assure safety.

Grain inspectors generally would also remain at work, in their case because budgets are funded by user fees.

USDA’s economics and statistical wing said “market news reports, NASS (National Agricultural Statistics Service) statistics and other agricultural economic and statistical reports and projections will be discontinued.”

“NASS will not issue any reports on days the government is shut down. We would assess the timing of any affected report releases after the government shutdown ends,” a USDA spokesman said.

The Economic Research Service, which provides analysis and forecasts, would be shuttered and its public website would be taken offline, said USDA. Agricultural research stations also would close, and reports from USDA’s Foreign Agriculture Service attaches around the world would be suspended.

The closely watched U.S. crop report, issued in tandem with projections of U.S. and global supply and demand estimates, is released a few days after USDA personnel complete surveys of growers and field inspections.

— Charles Abbott reports on U.S. federal farm and food policy for Reuters from Washington, D.C.

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