FDA | Center for a Livable Future

Will the U.S. Hog Industry Ever Kick Its Reliance on Low-Dose Antibiotics?

The editors of Scientific American recently encouraged U.S. hog farmers to “follow Denmark and stop giving farm animals low-dose antibiotics.” Sixteen years ago, in order to reduce the threat of increased development of antibiotic resistant bacteria in their food system and the environment, Denmark phased in an antibiotic growth promotant ban in food animal production. Guess what? According to Denmark’s Ministry of Food, Agriculture and Fisheries the ban is working and the industry has continued to thrive. The government agency found that Danish livestock and poultry farmers used 37% less antibiotics in 2009 than in 1994, leading to overall reductions of antimicrobial resistance countrywide.

: Courtesy: Ministry of Food, Agriculture and Fisheries, Danish Veterinary and Food Administration, July, 2010

Except for a few early hiccups regarding the methods used in weaning piglets, production levels of livestock and poultry have either stayed the same or increased. So how did Danish producers make this transition, and why isn’t the U.S. jumping to follow suit? Like many things in industrial agriculture, the answer is not clear.

If any country knows how to intensively produce food animals, particularly pigs, it is Denmark. In 2008, farmers produced about 27 million hogs. In fact, the Scandinavian country claims to be the world’s largest exporter of pork. Thus Scientific American editors argue that the Danish pork production system should serve as a suitable model to compare to ours. U.S. agriculture economists from Iowa State University agree. In a 2003 report, Drs. Helen Jensen and Dermot Hayes stated that Denmark’s pork industry is “…at least as sophisticated as that of the United States… and is therefore a suitable market for evaluating a ban on antibiotic growth promotants (AGPs).” Read More >

New FDA Numbers Reveal Food Animals Consume Lion’s Share of Antibiotics

Antibiotics, one of the world’s greatest medical discoveries, are slowly losing their effectiveness in fighting bacterial infections and the massive use of the drugs in food animals may be the biggest culprit. The growing threat of antibiotic resistance is largely due to the misuse and overuse of antibiotics in both people and animals, which leads to an increase in “super-bacteria”. However, people use a much smaller portion of antibiotics sold in this country compared to the amount set aside for food animals. In fact, according to new data just released by the Food and Drug Administration (FDA), of the antibiotics sold in 2009 for both people and food animals almost 80% were reserved for livestock and poultry. A huge portion of those antibiotics were never intended to fight bacterial infections, rather producers most likely administered them in continuous low-dosages through feed or water to increase the speed at which their animals grew. And that has many public health experts and scientists troubled.

For years scientists concerned about the threat of antibiotic resistant bacteria in food animal production have been trying to figure out just how much antibiotics producers are using each year. The best they could do was come up with rough estimates. That is because the data was never publicly available, until now. Read More >

Drug amounts for food animals now reported by FDA: Thanks, it’s about time!

The Food and Drug Administration (FDA) published a report last Thursday (Dec 9, 2010) that 13.1 million kilograms of antimicrobial drugs were sold or distributed for use in food-producing animals in 2009 in the United States (pdf). Why is this important? It represents the first time the FDA has reported the quantity of antimicrobial drugs that are available for use in the production of swine, dairy cow, cattle, and poultry in the US.

The recent FDA value also settles a longstanding dispute between the Union of Concerned Scientists (UCS) and an industry lobbyist group, the Animal Health Institute (AHI). UCS estimated that in 1998, 13.4 million kilograms of antimicrobials were used in food animal production, while for the same year AHI reported that just 8.1 million kilograms were used (Mellon et al. 2001). The new FDA report shows that UCS was much close to the actual amount than AHI. Read More >

Straight Talk About The Risks of Feeding Antibiotics to Food Animals

Courtesy: CDC

It is time for some straight talk about the risks of using massive amounts of antibiotics in livestock and poultry. I don’t know one infectious disease expert who would disagree that there are direct links between antibiotic use in food animals and antibiotic resistance in people. Period. If you don’t believe me just ask Rear Admiral Ali Kahn, Assistant Surgeon General and Acting Deputy Director for the CDC’s National Center for Emerging and Zoonotic Infectious Disease. Just this summer, during a hearing before the House Energy and Commerce Committee, Dr. Kahn testified that, “there is unequivocal evidence and relationship between [the] use of antibiotics in animals and [the] transmission of antibiotic-resistant bacteria causing adverse effects in humans.”

Knowing this, I continue to be frustrated with the fact that Agriculture Secretary Tom Vilsack does not publically recognize that the industrial food animal production system is a leading contributor to the increase of antibiotic resistance in pathogens that infect people and animals. Earlier this month at a National Cattlemen’s Beef Association meeting, Vilsack reportedly responded to a question about the Preservation of Antibiotics for Medical Treatment Act (PAMTA) by saying the, “USDA’s public position is, and always has been, that antibiotics need to be used judiciously, and we believe they already are.”

That quote had me scratching my head when I read it in a New York Times Op-Ed a couple of weeks ago. The Times’ editors interpreted the statement as saying Vilsack believes there is no need to change antibiotic use policy among food animal producers. That contradicts the positions of both the FDA and CDC. The Times pointed out that while neither regulatory agency is doing enough to address the problem both, at least, recognize that current antibiotic use should change. Read More >

Reading between the lines: FDA indicates consumer preference not a reason for salmon labeling

FDA hosted a hearing on Tuesday, September 21 to discuss the hypothetical labeling of genetically engineered (GE) salmon. Just fifteen hours earlier the FDA finished hearing the debate on GE salmon approval, which gave the impression that FDA was moving faster on the issue than it actually is. This compressed schedule caused frustration among experts, leading George Kimbrell of the Center for Food Safety to say “it is inappropriate to hold hearings on labeling before [GE salmon] are approved.”

In oral statements made before the FDA panel, Food and Water Watch (FWW) speaker Patty Lovera and the Alexis Baden-Mayer of Organic Consumers Association were not in favor of GE salmon, although if approved, Lovera recommended mandatory labeling of GE salmon. When pushed by the FDA panel on the material reasons for labeling, pro-labeling advocates often cited a lack of data on allergenicity of GE salmon or consumer preference. In a major break with other consumer advocacy groups, Gregory Jaffe from the Center for Science in the Public Interest indicated a preference for no GE labeling.

Salmon fillets in the grocery store (source: http://www.ctbites.com/home/2009/10/14/the-fresh-market-opens-in-westport.html)

If GE salmon is approved, the FDA has indicated that labeling will be based only on material differences in GE salmon compared to non-GE salmon, and not based on consumer preferences for GE labeling. These views may not be consistent with surveys that show 70% of American consumers want GE food to be labeled, from data reported by Jaffe.

Industry groups, including Richard Carnevale of Animal Health Institute, stood in line to argue that there were no material reasons why GE salmon should be labeled. The CEO of AquaBounty, Richard Clothier gave a series of other arguments against mandatory labeling, including the “slippery slope” that may lead to labeling of all GE foods and if labeling “complicated the process it would be a pity.” It appears that all stakeholders, including the FDA, realize this is a complicated process, and are willing to work through the difficult decisions.

If GE salmon is approved, consumers will have the ultimate say in its success. Salmon is the 3^rd most consumed seafood product in the US and its popularity and high market price will likely continue,whether or not consumers know what kind of salmon they are eating. It remains to be seen if the aquaculture industry realizes that the rising interest in communicating where and how our food is raised may be a benefit as opposed to a liability. Elliot Entis, the founder of AquaBounty, indicated he would be in favor of voluntary labeling as a type of product branding. Entis was in favor of calling their salmon “Panama Reds,” although one can only wonder if this is just a red herring.

- Dave Love

Independent advisory committee grills FDA on genetically engineered salmon

In a chilly hotel ballroom in the Washington DC suburbs, the FDA this week is considering whether to allow genetically engineered (GE) animals in the human food supply. The test case is an Atlantic salmon that has been engineered with Chinook salmon genes to express a growth hormone. The result is a fast-growing salmon that reaches market sooner than non-GE farm raised salmon.

A cast of stakeholders—industry, advocacy groups, academics, and regulators—are writing the storyline, but the climax— a pending decision by the FDA— is still a month or more away.One thing is clear, this FDA decision on GE salmon will set a precedent for other GE food animals in the US, and may influence regulations and practices in other countries already farming or considering farming salmon.

AquaBounty's AquaAdvantage Salmon (http://www.aquabounty.com/PressRoom/)

Is GE salmon a drug?

The approval mechanism for GE salmon, however convoluted it may sound, is as new animal drug. Approval of new animal drugs is under the purview of FDA’s Center for Veterinary Medicine (CVM). This approval process is similar to other GE animals used for pharmaceutical production (e.g. goats that produce drugs in their milk), and for research purposes (e.g. transgenic mice). Several speakers on both sides of the issue, including Bruce Chassy of the University of Illinois who is pro-GE, were confused why FDA did not instead allow its Center for Food Safety and Applied Nutrition (CFSAN) to take charge of regulating GE salmon as a food. One can only speculate that since CVM has been working with the drug sponsor, AquaBounty, for about a decade, certain CVM staff may feel some ownership over the issue. A clear rationale for why CVM and not CFSAN was in charge was not well articulated by FDA.

FDA carefully frames the issue.

To focus the debate, FDA’s CVM will consider just four main questions for GE salmon approval: i) are the inserted genetic elements harmful for salmon health?; (ii) are the salmon safe for humans to heath based on a “reasonable certainty of no harm”?; (iii) are the inserted genetic elements durable, heritable, and affect salmon such that it improves salmon growth rates as matching product claims?; and (iv) are there environmental risks if GE salmon escape? While striving to answer these key questions is admirable, the methods to address each issue use a reductionist view. Therefore the assessment is not designed for systems thinking about the intersection and interactions among diet, health, food production, and the environment.

What is missing from the debate?

What FDA is not considering in its decision is just as important as what it is considering. The FDA is not interested in assessing the food safety of the whole fish but rather its component parts in a non-additive way (i.e. hormones, nutrients and their separate toxicity or allergenicity). The FDA is not considering risk-benefit trade-offs in health from salmon consumption. The FDA will not consider ethical arguments against genetic modification, or biotechnology arguments for increasing food production as means of feeding the world. Animal welfare issues will also not be considered, as admitted by one FDA panelist.

An independent advisory committee was highly critical of the science.

A major component of the FDA hearings on September 20, 2010 was peer-review and recommendations from an independent advisory committed called the Veterinary Medicine Advisory Committee (VMAC). In what many considered a surprise, the VMAC committee was antagonistic of the FDA summary of the sponsor’s environment and food safety studies. On several instances the VMAC committee were concerned about the low sample size and power of the sponsor’s studies. The FDA responded that it had not performed power calculations to identify what an appropriate sample size should have been. Most VMAC committee members felt that larger and better-designed studies of food and environment safety were needed. This is a strong statement that the FDA should not ignore.

More to come from the next day of hearings, so stay tuned..

- Dave Love

CBS Airs Follow-up Report on Antibiotic Use and Congressional Hearing

The CBS Evening News with Katie Couric aired yet another report last night detailing the risks associated with feeding antibiotics to farm animals. The report is a follow-up to a series aired in February and reported on here in the LivableFutureBlog. In last night’s report, Couric covers Wedneday’s Congressional hearing held to determine whether or not the feeding of antibiotics to healthy farm animals could pose a significant health risk to humans. This was the third, and final, Congressional hearing on antibiotic resistance. At the hearing of the House Energy and Commerce subcommittee, a representative of the United States Department of Agriculture (USDA) finally caught up with the rest of the world—and his peers at the Food and Drug Administration (FDA) and Center for Disease Control and Prevention (CDC)—and admitted that the use of antibiotics in farm animal feed is contributing to the growing problem of deadly antibiotic resistance in America.Dr. John Clifford, Deputy Administrator for Veterinary Services for the USDA’s Animal and Plant Health Inspection Service (APHIS) read from his previously submitted testimony that the USDA believes it is likely that U.S. use of antibiotics in animal agriculture does lead to some cases of resistance in humans and the animals.

The Center for a Livable Future submitted a written statement to the House Committee. “The Food & Drug Administration recently released a draft “guidance document” that reviewed the evidence linking antimicrobial resistance to food animal production,” Dr. Robert S. Lawrence, Director of the Johns Hopkins Center for a Livable Future wrote. ” FDA concludes, ‘Using medically important antimicrobial drugs for production purposes is not in the interest of protecting and promoting public health.’ FDA clearly supports the conclusions of public health researchers discussed here, and has begun taking action in response to antimicrobial resistance accelerated by animal agriculture. No scientific debate exists on these issues–only political questions remain.

“I commend members for their leadership on this topic, and urge further action to fully prohibit using antimicrobial drugs for growth promotion and prophylaxis. Preserving the efficacy of antimicrobials in human medicine require immediate action, and I urge Congress to move quickly in taking steps to protect the public’s health.”

As reported previously in the LivableFutureBlog, a bill to limit the use of antibiotics–H.R. 1549, Preservation of Antibiotics for Medical Treatment Act–is awaiting committee action.

Many other influential media outlets are giving the issue of antibiotics in animal feed significant coverage. A recent article in DesMoinesRegister.com, “Antibiotics in livestock affects humans, USDA testifies,” notes the “Agriculture Department, which livestock producers have traditionally relied on to advocated for their interests, backed the idea of a link between animal use of antibiotics and human health.”

Antibiotic Resistance in Food Animals: FDA Takes Strong Stance, But Public Health May Remain At Risk Until Congress Acts

Leadership at the U.S. Food and Drug Administration (FDA) made it abundantly clear last week that the low-dose usage of antibiotics in food animals, simply to promote growth or improve feed efficiency, needlessly contributes to the emergence of antibiotic resistant bacteria and poses a serious threat to public health. Despite the fact that the FDA is taking a hard-line stance on the issue, I find it frustrating to see that the agency appears to be hamstrung from taking the necessary steps to mandate industry end the risky practice. Even more exasperating is that it appears that the FDA may actually relax a current directive that already regulates antibiotic use. However, unlike many critics, I don’t believe that this is an example of the Obama administration buckling under industry pressure. Rather, I view it as a loud and stern call for Congress to take action. Producers concerned more about profit than protecting public health are not going to cut their dependence on non-therapeutic antibiotic use in food animals unless lawmakers pass strict legislation.

House Committee Exempts Livestock & Poultry From Food Safety Bill. Where’s the Dissent?

Courtesy: Laura Padgett/Flickr

During my TV-news days, I supported the old axiom; it must be a balanced report if we’re getting just as much negative feedback as we are positive responses. I found the same rule of thumb to hold true on Capitol Hill. Good legislation usually means each side had to make serious concessions, inevitably leaving a number of unhappy people to complain about its inadequacies. Perhaps that’s why I’m feeling a little uneasy over the latest developments surrounding the long overdue Food Safety Enhancement Act of 2009. After some serious arm-twisting from Big Ag and members of the House Agriculture Committee, the members of the House Energy and Commerce Committee unanimously agreed Wednesday to alter the proposed legislation and “exempt livestock and poultry from oversight by the Food and Drug Administration.” I’ve heard a lot of praise for the committee’s bi-partisan approval of the bill, but where are the dissenters? Where is the healthy debate? Read More >

The Changing Food Landscape and the FDA

Baltimore’s former health commissioner, Dr. Joshua Sharfstein, is making news as the new deputy director of the FDA, serving under the new commissioner, Dr. Margaret Hamburg. Hamburg and Sharfstein have pledged to reform the food safety system and encourage scientific exchange and better communication to the public.

In the New England Journal of Medicine, Hamburg and Sharfstein acknowledged the difficulty of decision-making at the FDA, often in the absence of complete information, and admitted that recent high profile contaminations (peanut butter, anyone?) have rightfully caused the public to question the agency.

This is certainly a daunting task, but Hamburg and Sharfstein seem ready for the challenge (see some background on them here).

Indeed, there are many aspects of the food system that advocates for public health, the environment, animal welfare and social justice have identified as areas in dire need of improvement. The FDA will have the authority to address some of these issues, but not all. Some recent articles have discussed complicating factors that may impact the safety of the nation’s food supply. Read More >

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