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Ruling on FDA’s Oversight of Animal Antibiotic Use Called a ‘Big Blow to Public Health’

In a 2-1 decision, the U.S. Second Circuit Court of Appeals in New York City ruled Thursday that the U.S. Food and Drug Administration is not required to hold hearings concerning the safety of feeding antibiotics at subtherapeutic levels.

The ruling overturns two district court rulings from 2012 in a case initially filed in 2011 by the Natural Resources Defense Council (NRDC), the Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen, and the Union of Concerned Scientists.

The groups argue that FDA is required by statute to hold hearings to determine whether to withdraw approval for the use of penicillin and tetracyclines in animal feed after the agency declared that the subtherapeutic use of the drugs in animal feed “ha[s] not been shown to be safe” in the late 1970s.

Such hearings would be a requirement for industry to prove that the use of these drugs as approved is safe.

“If they were not able to do that, then FDA would have to proceed with withdrawing the approvals for those drugs, which would effectively ban those drugs in animals for food production,” said Keeve Nachman, a scientist at the Johns Hopkins Center for a Livable Future.

NRDC says that not requiring hearings means FDA “does not have to consider banning” the practice of feeding antibiotics to healthy animals.

“The science was there in 1977 and 40 years later, it’s only gotten stronger that these low-dose, routine use of antibiotics on livestock is causing development of antibiotic-resistant bacteria and that bacteria is coming off the farm in many different ways and affecting humans,” said Mae Wu, an attorney with NRDC’s health program.

“Today’s decision allows the FDA to openly declare that a particular animal drug is unsafe, but then refuse to withdraw approval of that drug,” wrote Judge Robert Katzmann in his dissent. “It also gives the agency discretion to effectively ignore a public petition asking it to withdraw approval from an unsafe drug. I do not believe the statutory scheme can be read to permit those results.”

Part of FDA’s argument in the case has been Guidance #213, which will ban the use of antibiotics for growth promotion in food animals, as an alternative strategy for dealing with resistance. But NRDC and other groups have argued that it won’t be effective at curbing antibiotic use on farms because “disease prevention” labels could simply replace those for growth promotion.

The Centers for Disease Control and Prevention estimates that at least 23,000 people die each year from antibiotic-resistant infections.

“Because of the link between antibiotic use in food-producing animals and the occurrence of antibiotic-resistant infections in humans, antibiotics should be used in food-producing animals only under veterinary oversight and only to manage and treat infectious diseases, not to promote growth,” reads CDC’s report on antibiotic resistance threats, released last September.

Today’s decision was a “big blow to public health,” Nachman said. “It’s tough to know where it’s going to go from here. I would expect that NRDC would appeal this decision in some manner; I would hope they would.”

When asked if NRDC plans to appeal Thursday’s ruling, Wu told Food Safety News, “I can’t say today what we’re going to do because it takes a lot more discussion, but we’re not discounting any options at this point.”

Food Safety News

Millennial generation called still ‘up for grabs’

The Millennial generation is “completely up for grabs” when it comes to choosing its patterns, including shopping choices, according to a presentation by Jason Dorsey, an author and business executive known as The Gen Y Guy.

Dorsey, who is chief strategy officer at The Center for Generational Kinetics, told the FMI Midwinter Executive Conference that the food industry can make a big impact with these consumers if it adapts to their needs.

“We haven’t yet established our loyalty,” he said of this generation, which includes him. “We’re still sampling. Yet we’re the No. 1 group to refer friends to come to you, because our friends don’t know what to buy or how to cook. We’re also just now establishing families, and have the most pent-up purchasing demand.”

Businesses need to understand this generation and be flexible in targeting it, he said.

Among the best strategies are:


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• Treat members of this generation as unique and special. “The No. 1 worst thing to do is to treat Gen Y members as numbers.”

• Adapt to the fact that Millennials are reticent to ask  questions face-to-face. “Because these consumers are uncomfortable asking questions, supply them with a mobile number to text questions to while they are in the store.”

• Make sure to engage these shoppers around their birthdays. “A birthday is the most important holiday for this generation. They make it into a birthday month. It’s the No. 1 way to engage them. It can be as simple as a quick message: ‘Have a happy birthday.”‘

In a related panel, food industry executives said they are focusing on recruiting and retention methods geared to Millennials.

Read more: FMI updates stance on GMOs

“Retention is what we all think about,” said Tanya Domier, CEO, Advantage Sales & Marketing. “Be very clear in laying out career journeys. Millennials will help architect their careers, which is motivating to them.”

Michael Polk, CEO, Newell Rubbermaid, said the company has fostered internal community through formation of a networking council, and has shifted its approach to charitable giving to make it more relevant to Millennials, among other employees.

“We’ve changed philanthropy work by putting money to work in areas that employees are interested in related to volunteerism.”

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AU: Abbott called to save fruit industry

AU: Abbott called to save fruit industry

Thousands of people impacted by SPC Ardmona (SPCA) cuts have called for the federal government to save the ailing fruit industry by following through with their $ 25 million pledge, made days before the September election.

SPCA owner Coca-Cola Amatil has reported business could close next year if the federal funding bailout is not met and then matched by the State Government, to contribute to the $ 120 million modernisation of its food production systems in the Goulburn Valley.

Thousands of producers will rally at Shepparton on November 28 calling on Prime Minister Tony Abbott to intervene on the initial report and commit to the multi-million investment package, flagged by the former government four days before the Federal Election.

“The silence coming out of Canberra at the moment is deafening,” Save SPC Armdona campaign co-founder Lee Lavara said. “How many trees need to be pulled down, how many growers incomes need to be cut and workers laid off, until someone sees the industry is folding before our very eyes. We’d like (Prime Minister) Tony Abbott to toss some important assistance in the budget to help the Goulburn valley region; this isn’t an attack, we are screaming out for assistance because next year the whole industry may not be here.”

Despite supermarket conglomerates Coles, Aldi and Woolworths switching to SPC Australian-grown home brands in place of cheap imports, Mr Lavara said the industry still desperately needed government support. “At the May (growers) rally, we asked for clearer labelling and we have been overwhelmed by how supermarkets have got on board,” he said. “It has made the Australian products more clear and increased sales by 50 per cent or better – a clear signal of what the consumer would like but the rest is up to big business and the government to make the correct decision to support us.”


Publication date: 10/17/2013