Food and Drug Safety
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Food Safety and Worker Safety Advocates Urge Vilsack to Withdraw Poultry Inspection Rule

A host of concerned groups and individuals wrote to Secretary of Agriculture Tom Vilsack today urging him to withdraw proposed changes to poultry inspection rules until food safety and worker safety concerns are addressed. The letter was signed by a range of food safety and worker safety groups and individual signers, including CPR Member Scholars Martha McCluskey, Thomas McGarity, Sidney Shapiro, and Rena Steinzor.

The letter explains the food safety and worker safety issues at stake, and takes USDA to task for its rushed approach:

The Food Safety and Inspection Service (FSIS) developed the proposal with limited public input. The agency did not adequately consult with its inspection advisory committee, nor did the agency hold public meetings to solicit the views of the public. Previous agency proposals that sought to substantially change parts of the federal inspection program have been debated and discussed in public forums so that stakeholder input could be provided prior to announcing a formal proposal.

Previously in this space, Rena Steinzor explained USDA’s proposed rule and the potential food safety and worker safety consequences, and described how USDA’s de-regulatory proposal was not subject to the rigorous analysis or interagency review that most regulatory proposals are.

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FDA Takes Baby Step Toward Protecting the Public from BPA

Yesterday, the U.S. Food and Drug Administration (FDA) announced that it would amend an existing food additive regulation to prohibit the use of Bisphenol A (BPA) in “infant feeding bottles (baby bottles) and spill-proof cups, including their closures and lids, designed to help train babies and toddlers to drink from cups (sippy cups).”  BPA, a chemical commonly added to polycarbonate resins (a fancy word for plastics), continues to raise concerns over its low-dose, endocrine-disrupting health effects.  Despite these health and safety concerns, the FDA’s decision to ban BPA in these limited items responds to a petition from the American Chemistry Council (ACC), which cites abandonment as the reason for the regulation amendment—not safety.

The good news about FDA’s BPA ban: FDA finally took an affirmative step toward protecting some of the public from BPA.  The bad news: the step is a meager one that establishes little more protection than state legislatures and grass-roots campaigns have already achieved through state bans and market pressures.  FDA, in other words, permanently banned BPA from products that already have removed it.

As I explained in a previous blog posting concerning CPR Member Scholar Noah Sach’s and my comments on the ACC’s petition and in CPR’s previous white paper on BPA regulatory options, FDA can take much larger and more meaningful steps to protect the public.  These steps begin with recognizing the safety and health risks associated with BPA and include implementing broader bans without regard to age and use limitations and mandating BPA labeling requirements.

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Antibiotics, Animals, and Agency Discretion

Cross-posted from Georgetown Law Faculty Blog.

When an agency defends over three decades of inaction on an important problem by saying that acting would take too long, one hopes a judge reviewing the agency's inaction will see through the pretense.  This is exactly what happened this week, when a federal magistrate judge in New York ruled that the U.S. Food and Drug Administration had acted arbitrarily in citing time and resource constraints in declining to limit the use of antibiotics in animal feed. 

Some 80 percent of the antibiotics used in the United States are given to animals destined to become part of our food supply.  Most of these drugs are given not to sick but to healthy animals; they are used not to treat disease but to promote animal growth or to prevent bacterial infections from occurring.  Both of these purposes are tied to the industrial nature of animal food production in this country.  The economic imperatives of industrial food production reward faster animal growth, and the microbial realities of the modern animal food production facility -- in which animals are tightly confined in stressful, bacteria-rich (to put it nicely), infection-promoting conditions -- encourage herd-wide administration of antibiotics to prevent infections. 

The widespread administration of antibiotics to food animals for non-therapeutic purposes has contributed to the development and spread of antibiotic-resistant strains of bacteria.  When bacteria become resistant to an antibiotic, that antibiotic will no longer treat the infection the bacteria cause.  Antibiotic resistance is to our wonder drugs what Kryptonite is to Superman.

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To Protect the Public, FDA Should Go Beyond Industry's Petition on BPA

CPR Member Scholar Noah Sachs and I submitted comments yesterday to FDA regarding the American Chemistry Council’s (ACC) petition to the agency on BPA. In September, the ACC petitioned FDA to remove approval for the use of BPA in “infant feeding bottles and certain spill-proof cups” (Rena Steinzor and I explained at the time the story behind the seemingly counter-intuitive move).

In our comments this week, we advocate for FDA to utilize its full rulemaking authority and take broader regulatory action to protect the public against BPA.  Specifically, we propose:

  • Issuing new regulations encompassing the ACC’s Petition and Rep. Edward Markey’s March 16, 2012 Petitions concerning abandoned uses;
  • Banning a much broader range of BPA uses without reference to age limits or target consumers; and
  • Mandating labeling of BPA in all food contact materials.

As we explain in the comments, convincing scientific evidence supports these broader measures because of the demonstrated low-dose effects of BPA and other endocrine disrupting chemicals.  These low-dose effects are not properly accounted for in current risk assessments of BPA and it is the role of FDA to act on behalf of all consumers' safety.

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Regulatory Opponents Take Note: The Media May Be Catching On!

One of the many ways that the slow and agonizing contraction of the newspaper industry is felt is in the depth of coverage that papers provide their readers. It’s a matter of simple math, really. As newsrooms shrink, reporters are stretched ever thinner. So a newspaper that 15 years ago had separate reporters covering elementary and secondary education is now likely to have just one covering both. Similarly, newspapers have fewer reporters dedicated to the environmental beat, let alone beats covering regulatory issues — topics at the heart of the Center for Progressive Reform’s work. The result is that many reporters don’t have time to take on stories they might once have covered, and if they do, they sometimes have a steeper learning curve and too little time to really dig in. That’s a recipe for simplistic coverage, which is just a nice way of saying bad coverage.

But I’d like to highlight two notable exceptions. On Tuesday, two of the nation’s leading newspapers offered stories about regulation that went far beyond the norm.

Think for a moment about the storyline on regulation for the past couple years. Republicans in Congress, intent on devising some rationale for the nation’s economic woes that does not point back to the failings of their own deregulatory policies, have resaddled their longstanding anti-regulatory campaign with a new and timely argument: that a supposed flood of regulations from the Obama Administration is choking off the recovery.

It’s a hard case to make if you stick to the facts. The truth is that regulations produce vastly more economic benefit than they cost – that is the purpose of the cost-benefit analysis wringer through which major regulations are fed before they are finalized. With very rare exception, if a regulation’s dollar benefits don’t exceed its dollar costs, it gets rewritten or killed. (And keep in mind that that the big failing of the cost-benefit process is that it overestimates costs and underestimates benefits.)

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FDA's "Wait and See" Approach to BPA Not Acceptable -- and Not the Only Option

Last Friday, the FDA denied the Natural Resources Defense Council’s (NRDC) citizen petition requesting that the agency ban Bisphenol A (BPA) as an approved food additive and food contact substance.  The agency took nearly three years to issue this decision, and did so only under a court’s order. The FDA’s denial of the petition was disappointing, because the existing science on BPA is strong enough to warrant restrictions on its use. The announcement was an unsurprising continuation of the federal government’s “wait and see” approach to BPA regulation. 

FDA spokesman Douglas Karas said that “this announcement is not a final safety determination and the FDA continues to support research examining the safety of BPA.”  There is no question that continued risk assessment and scientific study of BPA should be part of the FDA’s action plan for addressing the health and safety concerns that recent scientific studies on BPA have raised.  Earlier this year, CPR released a white paper, Protecting the Public from BPA:  An Action Plan for Federal Agencies, providing a list of short-term and long-term actions that federal agencies could take to address some of these mounting concerns about BPA.  At the top of our list for FDA was a continued and aggressive pursuit of the Agency’s collaborative research projects with the National Center for Toxicological Research and the National Toxicology Program.

In the meantime, however, I would remind FDA that a large body of scientific evidence already exists (and continues to collect) that supports increased restrictions on BPA’s use in food contact materials.  FDA itself has taken note of these concerns in its previous statements on BPA.  While FDA may see an all-out ban of this endocrine-disrupting chemical as too extreme or time-consuming, and continued scientific study is indeed imperative, there are a number of safeguards that would provide the public with some protections in the interim – much better than simply a “wait and see” approach.

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New CPR White Paper: What FDA, EPA, and OSHA Should do about BPA

Today CPR releases Protecting the Public from BPA: An Action Plan for Federal Agencies (press release), outlining steps the FDA, EPA, and OSHA can take to use existing authorities to warn the public about the dangers of the chemical, and prepare longer-term regulatory controls. The paper was written by CPR Member Scholars Tom McGarity, Noah Sachs, and Rena Steinzor, and Senior Policy Analyst Matthew Shudtz and myself.

Bisphenol A (BPA) makes me want to cry.  Not in the sad or mournful way, but in the “I want to kick and scream on the floor and throw a tantrum like my toddler” kind of way.   I didn’t always feel this way.  These feelings concerning BPA (an endocrine-disrupting chemical added to plastics to increase clarity and durability, and used in myriad other sources such as can linings, kitchen appliances, and water bottles) began to arise when I started working with CPR Member Scholars and fellow staff on BPA policy. The more I learned about BPA, the more I felt like its presence in my life was like mosquitoes in D.C.—a summer BBQ killjoy.

Then I became a parent, and the frustration and concern escalated, because the more I found out about BPA, the more I recognized that the industries using it did not truly understand how it affected my health, but more importantly, the health of my child.  Even worse, the new approaches to testing its “safety” and potential adverse health effects were churning out new evidence of its dangers.  Evidence that did not fit the traditional “risk assessment” model used by health and safety regulators and thus spurred no change in protective standards.

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Beware of Plastics Manufacturers Bearing Gifts of BPA Bans

This post was co-authored by CPR President Rena Steinzor and CPR Policy Analyst Aimee Simpson.

In what at first glance seemed to be a startlingly uncharacteristic move, the American Chemistry Council (ACC) has petitioned the Food and Drug Administration (FDA) to update and strengthen its food additive regulation that sets out the approved uses for polycarbonate resins.   For those who don’t speak plastic, “polycarbonate resin” refers to plastic that contains bisphenol-A or “BPA”—an endocrine-disrupting chemical with significant health risks, especially for babies. Polycarbonate resin is found in everything from reusable food and beverage containers, to tin can linings and thermal receipt paper. 

While usually a staunch defender of unbridled BPA use in all things plastic, the ACC actually asked the FDA to remove approval for the use of BPA in “infant feeding bottles and certain spill-proof cups.” If this request has you scratching you head, you are not alone. Could it be that the ACC has finally surrendered to the mounting scientific evidence concerning BPA’s low-dose endocrine-disrupting effects and accepted that, at the very least, BPA should not be permitted in beverage vessels meant for children? Has the chemical industry beaten its swords into plowshares and made a small but progressive gesture toward better BPA regulation? Unfortunately, a look at the petition and its potential implications shows that the answer to these questions is “no.” 

Thanks to consumer pressure and state and municipal legislative bans, major manufacturers of BPA no longer sell their products to the manufacturers of baby bottles and sippy cups.  The ACC bases the petition on a portion of the FDA regulation that invites people to point out when manufacturers have abandoned old uses.   But the ACC emphatically denies that BPA in baby products raises health concerns.

Instead, the ACC follows the by-now familiar route of blaming the victim—a.k.a. the consumer—for BPA’s removal. Under this rationale, manufacturers did not make these decisions on the basis of “scientific evidence or safety,” but rather were forced to remove the chemical because consumers are consumed by mass hysteria and forced the poor, beleaguered companies to do it. If it is able to rewrite the record in this way, the FDA will make a decision long desired by public health experts for all the wrong reasons, and the ACC will be able to claim that voluntary-abandonment-in-a-hostage-situation is the only real reason for the agency’s action.

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As More Sickened From Tainted Cantaloupes, House on Track to Cut Food Safety Budget

Last week, we learned that the nation suffered the deadliest outbreak of foodborne disease in the last decade or more. As Jensen Farms of  Granada, Colorado recalled millions of potentially contaminated “Rocky Road” cantaloupes, scientists at the Centers for Disease Control concluded that 15 deaths and 84 serious illnesses in 19 states were caused by melons containing the rare but exceedingly virulent bacterium Listeria monocytogenes. The disease they contracted, called Listeriosis, has a mortality rate of around 25 percent. Those victims who are fortunate enough to survive are at risk for meningitis and encephalitis.

In addition to being one of the most vicious of the known foodborne pathogens, Listeria is one of the more insidious bugs. The tiny bacteria can hide in the crevices of cantaloupes, remaining there after the fruit has undergone multiple washings. When the melons are sliced, the bacteria can find their way into the fruit where they can thrive at room temperature and even at temperatures commonly found in the refrigerator. Once the contaminated fruit is consumed the disease can germinate in the body for weeks before the victim feels its ill effects. The current outbreak is the first known outbreak attributable to Listeria in cantaloupes, but it will almost certainly not be the last.

Listeria is one of many pathogens that prior to the 1980s were associated primarily with beef and poultry. During the past twenty-five years, however, growers of produce have faced greater pressures from distributors and wholesalers on the efficiency of their production processes and procedures. The growers reacted by paying more attention to reducing costs and less attention to the safety of their products. The result has been a series of outbreaks of foodborne disease caused by contaminated produce. By 2004, the number of produce-related outbreaks exceeded that of beef, poultry and fish combined.    The Centers for Disease Control reported that almost 100 outbreaks of illnesses attributable to fresh produce between 1996 and 2006 caused over 10,000 illnesses and 14 deaths.

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BPA, the Chamber of Commerce, and a Summer Road Trip to Remember

Let’s go on a road trip. Whether it’s the beach or the mountains, we all know what going on a road trip means: great memories, possible adventure, time to mosey around the country we love. The Chamber of Commerce is also planning a road trip this summer, headed by former Sen. Evan Bayh (D-IN) and Andrew Card, George W. Bush’s former chief of staff. But fun and relaxation are not on the itinerary. Regulations that could protect our children are.

At ThinkProgress, CPR Member Scholar Sid Shapiro explained why the anti-regulation roadshow is ridiculous because of all the myths and misinformation it’s designed to promote. He’s right, of course, but, as a mother, I want to add another perspective. I’m tired of the well-worn refrain that “excessive” regulations “suck the vitality” out of the economy. Not only is the claim false, but it completely ignores all the time, money, and energy caregivers would save if we didn’t have to be on the lookout for toxics in our food and consumer products – the results of inadequate regulation.

Senator Bayh and Mr. Card, have you gone shopping for sippy cups lately? Have you purchased canned food, wondering if the linings contain BPA? Do you bite your tongue when a well-meaning teacher gives your child a plastic toy for good work from the “prize box”? Do you wonder if you need to replace your water pipes? Do you spend hours on the Internet researching safe products, or do you feel guilt because you have given up?

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