The saga of the missing FDA food safety regulations continues with a new government filing in a lawsuit challenging FDA’s failure to promulgate regulations implementing three critical programs that Congress established in the Food Safety Modernization Act of 2011. 

As I noted in a previous posting, the three sets of regulations are currently bottled up in the White House Office of Information and Regulatory Affairs (OIRA), where they have gathered dust for a year. 

Well before the statutory deadlines, FDA sent OIRA proposed regulations requiring most food processors and manufacturers to come up with hazard analysis at critical control point (HACCP) programs, requiring growers to comply with “science-based” minimum sanitation standards, and for importers to verify that their products were produced under conditions that complied with FDA food safety requirements.  But the deadlines came and went while OIRA sat on the regulations to avoid criticism from …

One of the crowning legislative achievements of the Obama Administration’s first term was the enactment of the Food Safety Modernization Act. 

Like any safety statute, however, the new law will have no practical bite until the implementing rules are issued. In this case, that’s until the Food and Drug Administration (FDA) promulgates regulations fleshing out the obligations of growers, producers and importers of food.  Unfortunately, after almost two years, the regulations for the three most critical programs enacted by the new law have been written, but have not yet been promulgated.

On Thanksgiving Day, one set of implementing regulations will have been bottled up at the White House’s Office of Information and Regulatory Affairs (OIRA) for exactly one year.  Two other critical sets of regulations will pass the one-year milestone between Thanksgiving and December 9. 

Signed by President Obama in January 2011, the new …

In the week before Christmas last year, 14-year-old Anais Fournier went to Valley Mall in Hagerstown, Maryland with some friends.  While there she purchased and consumed a 24-ounce can of an energy drink manufactured by the Monster Beverage Corporation.  She returned to the mall the next day and consumed another Monster energy drink.  Later that evening, while she was watching a movie at home with her boyfriend, she went into cardiac arrest. She died four days later on the day before Christmas Eve.  An autopsy concluded that she had died of “cardiac arrhythmia due to caffeine toxicity.”

Thanks to the efforts of her mother to get to the bottom of the matter, Anais’s untimely death may stimulate new efforts to regulate sports drinks and other potentially dangerous dietary supplements and to hold companies accountable in courts of law for their irresponsible marketing strategies.

Anais’s mother …

Yesterday afternoon, the D.C. Circuit Court of Appeals issued a long-awaited decision on the validity of EPA’s “Cross-State” rule governing interstate transport of pollution. 

The EPA has been trying for more than two decades to come up with a solution to the vexing interstate transport problem, but every attempt has failed. The court has now vacated EPA’s most recent (and most ambitious) attempt to protect the residents of “downwind” states (primarily in New England and the mid-Atlantic) from two pollutants (ozone and fine particulate matter) that can cause a number of adverse health effects, ranging from minor eye irritation to premature mortality.  EPA’s rule was estimated to prevent 13,000 to 34,000 premature deaths every year.

Worse, the court interpreted the Clean Air Act in a way that ensures that EPA may never be able to implement it with the analytical tools …

The Occupational Safety and Health Act of 1970 is one of the surviving monuments of the era of progressive social legislation (extending from the mid-1960s through the mid-1970s) during which Congress enacted the nation’s foundational health, safety and environmental laws. That statute empowered the Occupational Safety and Health Administration (OSHA) to write safety and health standards designed “to assure so far as possible every working man and woman in the Nation safe and healthful working conditions.” A separate “general duty clause” required every employer to provide a workplace that was “free from recognized hazards” that were likely to cause “death or serious physical harm.”

During the ensuing four decades, OSHA’s efforts to implement that statute have brought about substantial reductions in workplace injuries and illnesses, but far too many workers are still hurt or killed.

According to the Bureau of Labor Statistics, U.S. private …

The Government Accountability Office (GAO) released a report today detailing the challenges that the Occupational Safety and Health Administration (OSHA) faces in writing regulations to protect America’s workers from unsafe and unhealthful workplaces.  The report was released at a hearing of the Senate Health, Education, Labor and Pensions Committee, chaired by Senator Tom Harkin (D-Iowa), on “Delays in OSHA’s Standard-Setting Process and the Impact on Worker Safety.”  Both the GAO report and testimony presented at the hearing tell a depressing tale of an agency that, after 30 years of constant attacks from the business community, conservative think tanks, and reactionary members of Congress, has very nearly folded its rulemaking tent.

The GAO found that between 1981 and 2010, the time that it took for the agency to develop and promulgate occupational safety and health standards ranged from 15 months (for an easily promulgated safety standard …

Congress usually enacts new public protections following a major crisis or series of crises that focus attention on the failure of existing laws to protect the public or the environment from abuses by companies pursuing economic gain. 

Most of the protective regulatory programs of the Progressive Era, the New Deal, and the Public Interest Era (the period of active government extending roughly from the mid-1960s through the mid-1970s) were established after widely publicized tragedies or abuses stirred public opinion to levels sufficient to overcome the inertial forces that otherwise overwhelm Congress and the regulatory agencies.

Federal regulation of mine safety and health is an excellent example of this phenomenon.

The Federal Coal Mine Health and Safety Act of 1969 was enacted in direct response to the November 20, 1968 explosion at the Consolidation Coal Company’s Console Number 9 mine in Farmington, West Virginia that killed 75 …

Today marks the first anniversary of an event that received little media attention, but marked a major milestone in the progression of a regulation that is of great importance to thousands of Americans whose jobs bring them into contact with dust particles containing the common mineral silica.  Exactly a year ago today the Occupational Safety and Health Administration (OSHA) completed a proposed rule requiring employers in the mining, manufacturing and construction industries to protect their employees from silica dust particles as they engage in such activities as sandblasting, cutting rocks and concrete, and jackhammering.

Silica dust is no newcomer to the growing list of workplace hazards.  Public health professionals have known for more than one hundred years that exposure to airborne silica dust can cause a debilitating disease caused silicosis. 

In 1929, as the nation entered the Great Depression, hundreds of workers made their way to Gauley …

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 …