Sarah Klein | Food Safety News

USDA’s Poultry Proposal Endangers Eaters, Not Just Employees

Sarah Klein — Tue, 21 May 2013 05:03:56 +0000

Ever hear the one about how the well‐dressed accomplice caused a scene at the front door of the bank, while the masked robbers snuck in through the back and made off with the loot? Let that be a lesson to us: when we all train our eyes in one direction, we may miss the real danger lurking behind. As USDA appears to be ramping up a pre‐release publicity campaign on the new poultry inspection system, the agency is struggling with the commotion at the front door, where the food inspector’s union is firmly opposed to changes that could make the slaughter inspection business even more dangerous for employees. The agency continues to try to highlight the cost savings to companies and to the government, without acknowledging the harm that could be done to workers and consumers. But there is another equally troubling element in the proposal: that there is no requirement for plants to test for the pathogenic organisms that are nearly omnipresent in raw poultry. When USDA proposed its poultry inspection overhaul in 2011, unions were right to be concerned. The agency’s changes are both serious and sweeping: in addition to dispensing with much of the existing testing protocols, they propose to reduce inspectors and increase speed on the slaughter lines, and to shift responsibilities in the sorting room from inspectors to plant employees without requiring training, among others. Many of those changes would make a dangerous business even more so, and would do it without waiting for the findings of even a single long‐range study from the Occupational Safety and Health Administration about how it would affect slaughterhouse workers. This is no small affront, given that these workers serve as the first line of defense for ensuring that safe food reaches consumers (just as farm workers do for produce). But it is not just workers who should be concerned about the possible rules—anyone who eats poultry should be concerned about the proposal on public health grounds. The Obama Administration’s idea of “modernizing” poultry inspection is to permit each regulated company to decide what it wants to test for and how frequently. If you liked the results of letting banks regulate themselves, you may like the results of having big poultry companies controlling efforts to prevent contamination of meat and poultry. The tests and results would vary by company, making meaningful comparison impossible and limiting USDA’s ability to assess its program’s effectiveness or conduct strategic planning and reduce threats. These threats aren’t theoretical either. Hundreds of outbreaks and thousands of illness each year are linked to poultry, many from dangerous bugs like Salmonella and Campylobacter. CSPI’s recent report, Risky Meat, showed chicken and turkey on the top two tiers of a risk pyramid that ranked not just foodborne illness, but severe foodborne illness. That means the illnesses linked to poultry aren’t just inconvenient—they are far more likely to require hospitalization than many of the other meats we commonly eat. By the way, do you think USDA will stop at poultry or is this the future of beef and pork inspection too? In 2011, Congress passed an important law to improve the safety of foods that FDA regulates (foods other than meat and poultry). It’s high time that Congress updated the Poultry Inspection Act, which was passed more than 40 years ago, and makes USDA more prevention‐oriented as well. But rather than making wholesale change through rulemaking—and doing so in a sly manner that makes consumer advocates immediately wary that they have been disenfranchised—wouldn’t it be better to gather all stakeholders together to begin the difficult, necessary process of making meat and poultry safer? For an administration that lauds transparency, it is shocking for USDA to propose dramatic changes to poultry inspection without even the benefit of a single public hearing. If the goal of the project is truly to maximize public health, the agency should institute each change separately, spacing them out and gathering data at each new phase. It is not only common sense, but good science to assess each new change individually in representative slaughterhouses to determine if it has a measurable effect—positive or negative— on the frequency of contaminated birds. If the experience of passing a new food safety law for FDA taught us anything, it is that consumers, industry, and regulators can work together to further the goals of public health. Similar consensus was reached in the mid‐1990s, when then‐Secretary Dan Glickman convened all stakeholders in a series of public meetings to map out a modern program for preventive controls in meat and poultry products. When all parties trust that they share a common goal—to prevent illness—alliances like these can move mountains of public health policy in the right direction. When consumer and worker advocates speak out so strongly against a proposal like the one put forth by USDA to overhaul poultry, it should give everyone pause. Rather than speeding up the process and dashing for the getaway car, the agency should slow down and heed the alarms of its stakeholders.

FDA's New Posture Is Promising, Not Pathetic

Sarah Klein — Wed, 06 Feb 2013 06:02:55 +0000

This article was co-authored by David Plunkett. Both Klein and Plunkett work on food safety issues at the Center for Science in the Public Interest. As stakeholders begin wading in to the proposed food safety rules released by FDA this month, it is inevitable that some critics will begin cherry picking issues and holding them up as proof positive that the rules—and the entire Food Safety Modernization Act—are doomed to fail. That’s the position taken by Baylen Linnekin in an Opinion piece recently published on Food Safety News calling the proposals “pathetic” and “outrageous” (The FDA’s Pathetic Food Safety Proposal). But Linnekin overlooks much of FSMA’s value in his attempt to discredit the rules. One of the key elements—indeed, the central element—of FSMA was the paradigm shift that turned FDA from a reactive agency to a preventive one. While Linnekin sees that shift as agency overreach, most stakeholders view it as a needed and overdue change in food regulation, which has too often focused narrowly on the problems identified in the most recent outbreak. Many of those who worked on the law saw the focus on prevention as a fundamental shift in the way the FDA does business, and spent years crafting a law that maximized the benefits of prevention within the boundaries of realistic implementation. Linnekin says that “big business, academia, public health, the media, and government” were a “predictable” group of supporters. Ironically, Linnekin fails to see exactly how unpredictable such a coalition was. It is highly unusual for consumer advocates and industry groups, for example, to advocate together for the passage of reform—and yet that’s exactly what happened with FSMA. Not because, as Linnekin suggests, the law’s impact will be “minimal,” but instead because all the stakeholders recognized just how badly reform was needed. While there are many opinions on the new law and the proposed regulations, Linnekin’s attacks on the new law are too overt to pass over – it misses entirely the public health benefits that could result in three to five years from now. Consumers, and for that matter farmers and food producers of all sizes, need to celebrate passage of the Food Safety Modernization and here’s why. Foodborne illness is a serious national problem that deserves serious solutions. The Centers for Disease Control estimate that 48 million people suffer a foodborne illnesses each year. Of those, almost 128,000 require hospitalization and 3,000 die prematurely. It is estimated these illnesses cost American consumers an aggregate $78 billion each year in healthcare expenses, lost productivity, reduced quality of life and loss of life. Nationwide outbreaks and food recalls serve as regular reminders that Linnekin’s contention that food safety can be taken care of by conscientious farmers and food producers and eagle-eyed food-safety lawyers is just wishful thinking. Because symptoms may develop days and many meals after the exposure, it is difficult for consumers to connect the disease to its specific cause. That makes it difficult for eagle-eyed lawyers to win cases. In fact, less than one-third of foodborne disease lawsuits that survive to jury trial result in a finding for the plaintiff. Outbreaks tend to be an exception to the rule, because when many people get sick from a single food product, state public health officials can sometimes find the source. However, outbreaks have a down side for the industry. Consumers lose confidence in foods associated with outbreaks, and that has consequences for businesses producing similar foods. The conscientious farmers and food producers Linnekin mentions; they’re on the side of wanting regulation. Why? The outbreak of E. coli O157:H7 associated with bagged spinach in 2007 was traced to a single farm field, yet loss of consumer confidence cost the raw spinach industry $350 million in lost sales over the first year alone. The Peanut Corporation of America outbreak in 2008-09 cost all peanut farmers $1 billion in lost sales. Meanwhile, major peanut brands saw sales decline and spent millions of dollars on advertising to protect their brand even though they were not implicated in the outbreak. These losses were driving factors in why businesses as well as consumers came together to support the Food Safety Modernization Act. When Congress passed and the President signed FSMA, it was to bring our principal national food safety program into line with 21^st century knowledge about how to manage disease through prevention. It revised an antiquated law that focused on responding to problems after the fact instead of requiring adoption of modern prevention approaches already widely used by many food companies. In fact the goal of FSMA is to create a level-playing field, so companies using these approaches aren’t undersold by those who cut corners on safety. No law will eliminate all causes of foodborne illness. But following Linnekin’s logic would be like deciding it is hopeless to bail out a sinking boat because the ocean is too deep. In fact, every illness averted saves that consumer from a debilitating illness that invariably leads to days lost from work or caring for family members, and can sometimes lead to hospitalization and occasionally death. What about the costs? Using better food safety systems in food plants and preventing illnesses is literally spending pennies to save dollars: $500 million of cost for implementing reasonable safety measures could help avert $3 BILLION in cost imposed on consumers. And these costs include health care costs and lost wages. But the real driver for consumers, who overwhelmingly supported the passage and implementation of FSMA, is the strong desire to avoid the pain and suffering caused by these illnesses, which are easily averted with better control systems. Linnekin even cited research by the Center for Science in the Public interest in his argument that asserted that inspections declined, as did foodborne illness, as documented in the FoodNet program of the Centers for Disease Control and Prevention. But the data actually show something quite different: dropping rates of illness were largely associated with pathogens commonly found in meat and poultry, not FDA-regulated products. That nuance is extremely important, since the rates began dropping with the implementation of HACCP in those products 10 years ago. What the data actually shows is that instituting similar reforms at FDA—such as requiring preventive controls for farms and food processors—could send rates of bacteria in those foods falling as well. Linnekin’s evaluation is not wholly without merit. It is important to analyze tools, like FoodNet, to ensure they can measure the effectiveness of the new FDA food safety program. Additionally, his complaint that FDA will inspect high-risk facilities maybe twice in the decade illustrates that while much can be achieved with FSMA, that inspection rate hardly seems adequate. FDA could improve its record on enforcement, though admittedly there are some hopeful signs. Finally, there remains a problem of resources that Congress should resolve. How much money is needed? That’s an issue for another debate, but consider this: Last year the government spent more money looking for microbes on Mars than it spent looking for them in our food. Asking whether we have our priorities right when it comes to funding food safety at FDA would be a good place to start the discussion. During periods of change, particularly after lengthy periods of inaction, some skepticism is to be expected. It’s not unreasonable for stakeholders to ask FDA how it intends to accomplish some of the goals set forth in FSMA—and in particular to wonder how these precarious fiscal times will treat public health. But it’s unreasonable to draw premature conclusions as the rulemaking process begins. FSMA may not be a perfect vehicle for prevention, and FDA may not have all of the tools it needs to do the work of the law, but the intention to protect public health is unquestionably there. Critics of the process would do well to engage in making the regulations as protective and effective as possible, rather than tearing down efforts to move forward with food safety reform. Pictured: Mangoes imported from Mexico, photo courtesy of FDA.

Why Aren’t We Using Vaccines for E. Coli O157:H7?

Sarah Klein — Mon, 30 Jan 2012 01:59:01 +0000

For those who have been working on food safety for years — even decades — the promise of a quick-fix holds no allure. Experts know that food safety is multi-faceted, and no silver bullet exists to wipe the scourge of E. coli 0157:H7 from existence. But where promising new technologies could — in combination with common-sense approaches — make serious contributions to public health, they should be advanced. Pre-harvest vaccines for E. coli O157:H7 could very well be one of them. So why aren’t we using them?

At least two promising vaccines for E. coli O157:H7 are awaiting licensing approval from the Center for Veterinary Biologics (CVB) at APHIS. CVB has a long history with animal vaccines, but has primarily focused on those that improve animal health — not human health. The E. coli vaccines under consideration are not designed to prevent illness in the animal, but could significantly decrease the amount of the pathogen present in the pre-harvest environment, and presumably in the meat that winds up on consumers’ plates. Vaccines focusing on public, rather than animal, health represent fairly new ground for the agency. Given the delays in their approval, CVB may be having trouble adjusting its vision.

In a series of conversations with many of the players involved — representatives from CVB and the pharmaceutical companies awaiting licensure — CVB’s approach has been striking. Far from being enthusiastic about the public health possibilities of pre-harvest vaccines for E. coli, the agency instead seems beleaguered and adrift on the issue, even admitting in one conversation that although there’s no scientific downside to the vaccines, there are some economic and practical issues to consider. Perhaps there are economic and practical issues to consider — but that’s not CVB’s mission. The fiscal implications and logistical applications to these vaccines are issues for the free market to deal with, and not reasons to delay licensing of promising new technologies that could make a significant public health impact.

The key issue for CVB — indeed, the only issue the agency has authority to consider — is whether the vaccines are pure, safe, potent, and effective. In meetings with CVB officials, the agency acknowledges that the vaccines under consideration have cleared the first three hurdles. It’s the efficacy that appears to be tripping them up. CVB says that the industry wants an expectation of efficacy that would decrease summer E. coli shedding rates in cattle to approximate winter shedding rates, an efficacy of between 55 and 65 percent. This is a laudable goal, and it’s useful to know what the industry would like to see from a new pre-harvest tool to combat contamination. But surely the Food Safety and Inspection Service (FSIS), the agency whose mission is to ensure the safety of meat for consumers, has an opinion on whether that expectation of efficacy is too high, too low, or just right? Unfortunately, CVB doesn’t know it. From what we can tell, CVB has a bold new responsibility to consider vaccines with a possibly significant public health impact, but they haven’t taken steps toward a meaningful collaboration with the relevant public health agency that sits in the same building to decide how best to exercise that power.

How CVB came into its responsibility for vaccines that have a public health focus (rather than the traditional animal health focus) is somewhat mysterious. Perhaps it was simply that the agency was left without a chair when, in the early 2000s, the music stopped on a debate about where to house these types of animal vaccine approvals. True or not, the agency has entered a new era — one where their focus on animal health must share the spotlight with a commensurate consideration for public health.

It’s time for CVB to embrace that new responsibility, first by re-focusing on its actual statutory mission and away from tangential issues of practicality and economy. Second, the agency must consult with FSIS and gather the relevant stakeholders to discuss how vaccines can make a contribution to public health. Third, CVB should streamline and make more transparent the entire process of vaccine approval, so that interested parties can follow the progress — or lack thereof — of promising technologies under consideration.

There’s no guarantee about these vaccines, but even without a silver bullet, it is possible much progress can still be made. CVB has the authority and the responsibility to put yet another tool in the box to fight the scourge of E. coli. Now the agency must rise to meet its new public health role, by streamlining, prioritizing, and publicizing the vaccine approval process for those technologies that could have a significant impact on public health.

Here’s a letter written by the Center for Science in the Public Interest to USDA Secretary Tom Vilsack about the delay in vaccine approvals.

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Sarah A. Klein, J.D., M.A. is Staff Attorney, Food Safety Program, at the

Center for Science in the Public Interest