Three Cheers for the FDA!!!

Posted on April 5, 2013 by Robert Falk

In the wake of salmonella, e-coli, and listeria outbreaks in the nation’s food supply, and driven by fears concerning contaminants like melanine and lead being imported in foods from developing countries like China, the U.S. Food and Drug Administration’s (“FDA’s”) food safety assurance programs have fallen under much criticism in recent years.  In a rare instance of bipartisan consensus in this day and age, in 2010, Congress overwhelmingly passed and, on January 4, 2011, President Obama signed, Public Law 111-353, the Food Safety Modernization Act (“FSMA”).  FSMA, in turn, required FDA to provide the first comprehensive update to its food safety programs in decades. 

On January 16, 2013, almost a year behind the schedule set by Congress, FDA published two significant draft rules and accompanying preambles to implement FSMA’s upgraded food safety system requirements (78 Fed. Reg. 3504 ; 78 Fed. Reg. 3646).  In these two significant rulemakings, FDA essentially proposes to:  (1) add to an updated set of its longstanding “good manufacturing practices (“GMP”) requirements (found in 21 C.F.R. Part 110), a mandate that all food processors implement hazard analysis and critical point of control (“HACCP”) programs, and (2) to require growers of food commodities that will not be subject to extensive processing to implement programs of good agricultural practices (“GAPs”).

Kudos to the FDA for proposing such a sensible approach to addressing Congress’s goal of ensuring enhanced food safety in America.  Rather than making requirements more prescriptive, FDA instead has essentially proposed to require food processors not already subject to HACCP requirements to conduct these disciplined analysis of food safety hazards “reasonably likely to occur” and then have the results of that risk-based analysis drive the processors to further identify, implement, and track the additional compliance measures necessary to address the potentially significant hazard presented.  In the GAP context, FDA has taken the additional step of itself analyzing the food safety hazards that are “reasonably likely to occur” in fresh produce and concluded (subject to public comment) that microbiological risks are the hazards at the farm level warranting the imposition of GAP requirements under the law for the first time (rather than merely as recommendations as has been the case until now).

Politicians, regulators, and environmental lawyers and activists too often dismiss or merely give lip service to risk-based analysis and regulation, but, at least here, FDA proposes to meaningfully embrace and apply the approach so as to allow food safety management and control resources to be best allocated to protecting the public’s health and safety.  Hat’s off to the FDA!!!

TSCA Reform: The Battle Continues

Posted on February 7, 2013 by Lynn L. Bergeson

For Toxic Substances Control Act (TSCA) aficionados, a new federal legislative session holds the promise of long overdue legislative reform.  Among the oldest environmental laws, it is also the most neglected.  While hope springs eternal, the odds are against reform any time soon.  A deeply divided Congress makes any environmental measure contentious.  Pile on other Congressional priorities, including immigration reform, gun safety, and climate change, and we have the makings of more Congressional inaction and gridlock.

It is against this backdrop that we await introduction of Senator David Vitter’s (R-LA) TSCA reform bill, expected this month.  As the new ranking Republican on the Senate Environment and Public Works Committee, Senator Vitter’s much-awaited bill marks the first Republican alternative to Senator Frank Lautenberg’s (D-NJ) long-standing TSCA reform measure, the Safe Chemicals Act.

Among many contentious issues is the TSCA safety standard.  Senator Lautenberg’s bill contains a “reasonable certainty of no harm” standard to replace the current “unreasonable risk” standard.  This language is found in the 1996 Food Quality Protection Act and defines the applicable standard for pesticide exposures in food.  A key area of controversy is whether such a standard for food safety is appropriate for chemical exposures, or otherwise represents a “zero risk” standard that likely would inspire epic regulatory costs for questionable improvements in true risk reduction.  In the void left by Congressional inaction, state measures are gaining ground.  The California Safer Consumer Products Regulations are expected to be issued in final form sometime this year.  This game-changing approach to assessing the safety of chemicals in consumer products by requiring chemical “alternative” assessments may well become the default safety standard in the absence of federal legislation.

2013 will be a watershed year for domestic chemical management initiatives.  Even if federal inaction continues, a California initiative, like so many others in the past, may prevail and take domestic chemical product safety to places and levels Congress declines to go.