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Jan. 6, 2014 by Lisa Heinzerling

Secrecy protects only laggards: why the FDA should disclose which drug companies volunteer for its “judicious use” policy for livestock antibiotics

The Food and Drug Administration (FDA) recently recommitted itself to its lame proposal to address the profligate use of antibiotics in livestock by enlisting the voluntary participation of the drug companies that make the antibiotics.  Two documents issued last month reveal the details of the agency’s current plans.   The first is a final guidance document describing the FDA’s process for handling drug sponsors’ voluntary efforts to phase out “production uses” of antibiotics in animal feed and water and to bring the remaining uses under the oversight of a veterinarian. The second is a draft rule relaxing the requirements for veterinarians in exercising this oversight.  Production uses are aimed at promoting growth and improving feed efficiency, not at treating active infections.  The FDA will continue to allow mass medication of whole herds and flocks of livestock for purposes of preventing infection.

The FDA has, in internal documents, conceded that “all” of the relevant drug companies must participate in order to make its approach work.  But there is no guarantee that even a significant number of these companies will voluntarily give up production uses simply because the FDA asks them to.  Even if some do – Zoetis and Elanco have said …

Dec. 19, 2013 by James Goodwin
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It’s like a Russian nesting doll of bad policy:  House Republicans have contrived to take one of the most anti-science bills in memory and then place it inside one of the most anti-democratic legislative vehicles available.  It’s part of an attempt to ram through into law new rulemaking requirements that would benefit the already-healthy bottom lines of their corporate benefactors at the devastating expense of the health, safety, pocketbooks, and perhaps even lives of the American public.  That’s what is at stake with an obscure three-page rider—Section 12307, euphemistically entitled “Ensuring High Standards for Agency Use of Scientific Information”—in the 700-page House version of the Farm Bill (H.R. 2642, the Federal Agriculture Reform and Risk Management Act of 2013) that is currently undergoing conference committee consideration to resolve differences between it and the Senate version of the Farm Bill.  (See page …

Dec. 19, 2013 by Celeste Monforton
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Many Senate Democrats try to paint themselves as defenders of working people. They rail against their colleagues who are “in the pockets of corporations and the rich.”  But what they say, and what they do are two different things. This time, seven Democratic Senators are ready to screw poultry workers to please the owners of the poultry companies.

We’ve been writing for nearly two years on the USDA’s plan to “modernize poultry inspection” (e.g., hereherehere, here). It’s a plan that will give Tyson, Perdue, Pilgrims’ Pride and other poultry producers an additional $250 million a year in revenue. It will allow USDA to eliminate 800 inspectors, and it won’t improve, and could make worse, food safety. To “sell” poultry companies on the plan, USDA will allow them to increase line speeds up to 175 birds per minute.

The industry and …

Nov. 20, 2013 by Rena Steinzor
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When we all sit down for Thanksgiving dinner next week, we hope that the food we are feeding our families is wholesome and that the workers who produce it are safe.  Thanks to the U.S. Department of Agriculture (USDA), ever the mindless booster of corporate profits, that turkey at the center of the table already disappoints both expectations, and if USDA has its way, matters are about to get much worse.  Hiding behind disingenuous promises to “modernize” the food safety system, USDA has decided to pull federal food inspectors off the line at poultry processing plants across the nation.  No new preventative measures to ensure that poultry is free of salmonella would happen.  And already crowded, bloody, stinking lines would speed up dramatically—to as many as 175 birds per minute, or three birds/second. Workers who suffer grave ergonomic injuries from the repetitive motions of …

Nov. 18, 2013 by Lisa Heinzerling
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The Food and Drug Administration recently announced its tentative determination that most of the trans fatty acids in our diets – specifically, partially hydrogenated oils (PHOs) – are not “generally recognized as safe” within the meaning of the Food, Drug, and Cosmetic Act, and thus must be regulated as food additives. If the FDA finalizes this determination, then food manufacturers would need to obtain the approval of the FDA before selling PHOs in any food or as food ingredients. Approval would then depend, in turn, on a determination by the FDA that PHOs were safe after all. In this way, a final determination by the FDA that PHOs are not “generally recognized as safe” would effectively amount to a ban on their use in food.

The FDA’s proposed finding is a huge deal for public health. The agency estimates that eliminating PHOs from the food supply could prevent …

Nov. 14, 2013 by Michael Patoka
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CPR Member Scholars Rena Steinzor Lisa Heinzerling, Tom McGarity, Sidney Shapiro, and I submitted comments to the FDA on two food safety rules—one on raw produce, and one on preventive controls for human food (which applies to food manufacturers and processors).

In separate blogs posted today, we address issues of regulatory design and how the costs of both these rules would be significantly smaller than suggested in the FDA’s economic analyses. Here, we explain why these rules offer much greater benefits than those presented in the agency’s analyses. (The analyses for both rules essentially rely on the same benefits methodology.) 

The FDA estimates that the produce rule would prevent about 1.75 million foodborne illnesses, representing an annual benefit to society of $1.04 billion. For the preventive controls rule, the FDA calculates the annual burden of illnesses attributed to processed foods—nearly one …

Nov. 14, 2013 by Lisa Heinzerling
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One of the healthiest things a person can do is to eat lots of fruits and vegetables. Unless they’re contaminated with dangerous pathogens, that is. Contaminated produce has been responsible for an alarming number of deaths and illnesses in recent years, from Listeria-tainted cantaloupes that killed up to 43 people in 2011 to a Cyclospora outbreak linked to salad mix and cilantro that sickened 631 people in 25 states this past summer. 

For this reason, the Food Safety Modernization Act (FSMA) directed the Food and Drug Administration (FDA) to set standards to ensure the safety of the fruits and vegetables in our food supply.   The FDA’s proposed rule on produce safety would address some of the most likely sources of contamination on farms, including tools and equipment, water used in agricultural activities, and worker health and hygiene. At the Center for Progressive Reform we …

Oct. 25, 2013 by Michael Patoka
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Last Friday, the FDA posted the revisions the White House Office of Information and Regulatory Affairs (OIRA) made to two food safety rules drafted by the agency two years ago. The proposed rules were issued under the Food Safety and Modernization Act, which Congress passed in the wake of widespread food safety disasters.

As we’ve mentioned in this space before, OIRA is the regulatory review body within the White House that frequently holds onto agency rules for longer than the 120-day limit set by Executive Order 12866, often mangling and weakening the protections developed by agencies at the behest of regulated industries. For one of these rules, on the Foreign Supplier Verification Program (FSVP), OIRA didn’t loosen its grip for a year and eight months, giving it plenty of time to tinker around with the FDA’s proposal behind closed doors.

According to a memo …

Oct. 17, 2013 by Rena Steinzor
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Salmonella outbreak reveals we need more, not fewer, cops on the food safety beat. 

Some 317 victims of salmonella poisoning from Foster Farms chicken sold in 20 states have learned firsthand why we need government.   Who knows how much faster the threat would have been contained if Centers for Disease Control (CDC) experts had been walking their usual beat, coordinating state investigators and working frantically to discover the origins of the virulent strain of salmonella that has already hospitalized 42 percent of the 317 victims?  

Instead, the investigators were sent home on furlough, and only recalled to work after the scandal hit the media.  

CDC investigators are a vital link in the chain of public protection because they are the people who “trace back” illness to its source. Obviously, knowing someone has salmonella poisoning is not enough: we also need to know which food, from what company …

Sept. 4, 2013 by Rena Steinzor
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We’ve often written in this space about the Obama Administration’s very bad idea to take federal inspectors of the line at poultry processing plants, leaving the discovery of blood, guts, and feathers on the carcasses to overworked and underpaid line workers forced to process as many as 70 birds per minute at the average plant. The U.S. Department of Agriculture (USDA) is the architect of this proposal to “modernize” the food safety system without requiring a single additional test to make sure the birds are not infested with salmonella, campylobacter, and other bad bugs. Confirming the rule’s primary role as a windfall for the poultry industry, USDA’s initial cost-benefit analysis indicated that it would save companies like Holly Farm, Tyson’s, and Perdue $250 million annually. That windfall is attributable to the fact that under the proposal, the line speed will at …

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