Dec. 7, 2015 by Mollie Rosenzweig

FDA and the Future of 'Frankenfish'

If you've come across one of the ads, newspaper stories, or opinion pieces from Chuck Norris in the past week warning you about frankenfish, you can thank the FDA. In mid-November, the FDA made history by approving the first genetically engineered (GE) animal for human consumption, Atlantic salmon from the company AquaBounty. Not only has the approval process failed to win over skeptics, exposing the weaknesses in the current legal regime that governs plants and animals developed through biotechnology, it raises important questions about the future of food oversight. With emerging genetic technologies on the horizon, can federal agencies continue to exert control over approving genetically altered plants and animals under a legal scheme that never imagined the technologically advanced foods of today and tomorrow? 

AquaBounty created the AquAdvantage salmon by combining the growth gene from the Chinook salmon and a “promoter” gene from another species with the genetic code of the Atlantic salmon. The genetic modification allows the GE salmon to grow to market weight in about half the time it takes wild Atlantic salmon – around two years instead of four. The GE salmon are raised in tanks on land, in Canada and Panama; the Canadian facility contains …

Oct. 6, 2015 by Sidney Shapiro
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The resignation of House Speaker John Boehner and the VW diesel car scandal -- two rather extraordinary events -- might not initially appear to be related, but there is a connection. The most conservative members of the Republican caucus celebrated Representative Boehner's resignation because they felt he did not fight hard enough to shrink the size of the federal government through more aggressive tactics, like government shutdowns. Although one of government's most important functions is to deter behavior such as that of VW, the radical Republicans would organize American society using only markets, not government. The difficulty with this stance is that corporations "cheating" consumers is an unavoidable aspect of capitalistic markets, making government regulation a necessity.

Adam Smith in the Wealth of Nations famously identifies an "invisible hand" by which individual self-interest has the effect of benefiting society more effectively than when an individual intends to …

Sept. 22, 2015 by Robert Verchick
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Center for Progressive Reform President Robert R.M. Verchick issued the following statement today in response to the burgeoning Volkswagen emissions scandal:

With the Volkswagen emissions scandal, hard on the heels of the GM settlement, can anyone doubt the importance of strong regulation and tough enforcement? One automotive giant let a safety problem fester for a decade while more than 120 people died as a result. Another conspired to cheat on state emissions tests, pumping outrageous loads of pollution into the air we breathe so that they could make their cars peppier, and advertise them as such. We hear conservatives say all the time that regulation is unnecessary because the market is self-correcting. The scope of these scandals proves just the opposite: We need vigorous regulation and enforcement to keep Americans safe from companies that think they can increase their profits by endangering us all.

Sept. 21, 2015 by Erin Kesler
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Today, Stewart Parnell, former peanut company executive was sentenced to 28 years in prison for his role in a salmonella outbreak that resulted in the deaths of nine people and the illness of 174.

CPR Member Scholar and University of Maryland School of Law professor Rena Steinzor issued the following statement in response to the sentencing:

This sentence shows that the courts are willing to drop the boom on white collar criminal defendants whose elevation of profits over safety go so far as to kill people.  Parnell ordered the shipment of peanut paste contaminated by salmonella that not only killed nine people, but also produced one of the biggest recalls in food safety history.  His factory was a disgusting place, with broken equipment, a leaking roof, and rodent droppings throughout.  Hopefully, this kind of prosecution will motivate the Congress to fully fund FDA efforts to prevent such …

Sept. 17, 2015 by Rena Steinzor
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CPR Member Scholar Rena Steinzor reacted to today's announcement of a settlement between General Motors and the Justice Department over charges stemming from the company's failure to disclose a deadly ignition defect it millions of its cars. Steinzor said:

This settlement is shamefully weak. GM and its executives knew for years that they had a big problem with the ignition switch, which caused cars to stall at high speeds, depriving drivers of power steering, brakes, and airbags.  The company’s dysfunctional culture convened committees to palaver about it, while nothing was done, a culture described by Mary Barra, GM’s CEO, as “the GM nod.”  But daunted by the company’s size and prestige, U.S. attorney Preet Bharara blinked, collecting $900 million as a cost of doing business, but excusing GM from admitting its criminal wrongdoing.  This kind of sweetheart deal shows that justice …

Sept. 14, 2015 by Thomas McGarity
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At long last, the Food and Drug Administration has promulgated two critical regulations implementing the Food Safety Modernization Act of 2011 (FSMA).  The regulations flesh out the statute’s requirements for facilities that process human food and animal feed.  Of the regulations that FDA has proposed in order to implement the FSMA, these are perhaps the least controversial.  Indeed, they have won praise from everyone from the Grocery Manufacturers Association to the food safety director of the Pew Charitable Trusts.  This blog post focuses exclusively on the regulations governing human food. 

The regulations require all processors of human food to prepare and maintain plans for ensuring that their products are not contaminated with pathogens.  A processing facility must conduct a hazard analysis and institute preventive controls to mitigate the hazards identified in the analysis.  The company must monitor those controls, conduct verification activities to ensure that the …

March 30, 2015 by Frank Ackerman
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There must be a global template for business complaints about regulation, located on some secret right-wing server. Just type in the industry and the name of the regulation: Billions of dollars are at stake, companies will be driven out of the industry and consumers will lose access to low-priced products, if the government dares to impose an ordinary, common-sense rule. Such as, making drug companies responsible for the safety of their products?

Aren’t pharmaceutical companies already responsible for warning their customers of known adverse effects? If you answered “yes, of course,” then you missed the Supreme Court’s 2011 ruling in Pliva v. Mensing. Currently, generic drug companies are required by the Food and Drug Administration (FDA) to use exactly the same labels and warnings as the corresponding brand-name drugs. Therefore, the Court ruled in Mensing, the producer of a generic drug cannot be held responsible …

March 1, 2015 by Matthew Freeman
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Last December, the Justice Department announced the indictiment of the owner/head pharmacist, the supervising pharmacist, and 12 others associated with the New England Compounding Compounding Center. The 131-count indictment, which included 25 charges of second-degree murder, grew out of a 2012 outbreak of fungal meningitis caused by contaminated drugs manufactured by the company. More than 750 patients were diagnosed with the illness as a result, and 64 patients in nine states died from it. 

In a February 28, 2015, op-ed in USA Today, CPR President Rena Steinzor, author of Why Not Jail? Industrial Catastrophes, Corporate Malfeasance, and Government Inaction, recounts the story and then takes a look at how policymakers reacted, and what came of their response. The tragedy laid bare a gaping hole in the nation's regulatory fabric, and rather than addressing it with straightforward legislation and resources to enforce it, Congress pass a …

Aug. 20, 2014 by Daniel Farber
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FDA has stalled for 30 years in regulating antibiotics in animal feed. A court says that's O.K.

The FDA seems to be convinced that current use of antibiotics in animal feed is a threat to human health. But the Second Circuit ruled recently in NRDC v. FDA that EPA has no duty to consider banning their use.  That may seem ridiculous, but actually it’s a very close case legally.  The court’s discussion of Massachusetts v. EPA as an administrative law precedent should be especially interesting to environmental lawyers.

The Second Circuit’s ruling illustrates the tremendous discretion that agencies generally have about how to order their priorities and what tools to use to address problems.  That discretion isn’t unlimited, but it’s extremely broad.  It’s not necessarily improper — in fact, it’s fairly normal — for an agency or a President to …

Jan. 13, 2014 by Rena Steinzor
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Today, U.S. Department of Agriculture (USDA) sent its benighted poultry-processing rule to the White House for final review.  The millions of consumers who eat undercooked chicken at their peril and the beleaguered workers in these dank, overcrowded, and dangerous plants can only hope the President’s people come to their senses over there and kill this misguided fiasco.   

Ordinarily, we would have hoped that newly installed Department of Labor secretary Tom Perez would have put his foot down before USDA proceeded with the final rule, but after months of pleas from the National Council of La Raza, African American labor advocates, trade unions, and consumer groups across the spectrum, he has remained aloof.  Apparently, the economic needs of multi-billion dollar poultry processing companies that have brought us salmonella outbreak after salmonella outbreak will once again trump the needs of the consumers and workers, especially Hispanic and …

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