The food we eat, the clothes we wear and the toys we give to children are such integral parts of our lives that we often don’t give them a second thought. But in recent years reports of Salmonella outbreaks and high lead levels have spurred concern over food and consumer product safety.
In an effort to combat these hazards, the U.S. government has introduced the 2008 Consumer Product Safety Improvement Act and 2011’s Food Safety Modernization Act. In our January cover story, “Safe Measures,” InsideCounsel examines the implications of these two pieces of landmark legislation and provides expert advice for companies seeking to comply with their requirements.
What is the history of the Food Safety Modernization Act (FMSA)?
A series of well-publicized Salmonella outbreaks—linked to foods such as peanut butter, eggs and tomatoes—helped to spur the January 2011 passage of the FSMA. The law’s aim was to emphasize the prevention of outbreaks, rather than focusing on the reaction to those outbreaks.
Under the FSMA, facilities that manufacture, process or package food must register with the Food and Drug Administration (FDA), which has the power to suspend the registration of processors if it finds they have produced food that is likely to cause serious adverse health consequences. The FDA also has mandatory recall authority as part of the law, although it says it will only use this power if companies fail to issue a voluntary recall.
What other measures did the FSMA introduce?
The FSMA also mandates that facilities that manufacture, process and package food must implement food safety plans that identify the specific safety risks of their products, create procedures to minimize or avoid these hazards and identify corrective steps to be taken in case of contamination. Although that requirement went into effect in July 2012, the FDA missed the deadline for issuing regulations implementing the law
Earlier this month, the FDA finally proposed two new food safety rules connected to the law. One requires companies to establish the formal food safety plans outlined above; the other sets national quality standards for farms that produce and harvest fruits and vegetables.
What implications does the FSMA have for businesses?
Because the FSMA does not preempt state and local laws, some experts note that food companies will not be able to follow the example of drug and device companies when it comes to litigation.
Joseph Levitt, a partner at Hogan Lovells and the former director of the FDA’s Center for Food Safety and Applied Nutrition, also notes that the FDA, as a whole, has increased its enforcement efforts in recent years. “It shows how important it will be to comply with the FSMA,” he says. “If the FDA is enforcing the old rules vigorously, it will likely enforce the new rules even more so.”
What is the Consumer Product Safety Improvement Act (CPSIA)?
The 2008 passage of the CPSIA followed a spate of children’s toy recalls prompted by concerns over excessive lead levels. Among its measures, the act established a mandatory testing and certification process for manufacturers in an effort to keep high levels of lead and phthalates out of children’s products.
The CPSIA also increased the staff and budget of the Consumer Product Safety Commission, instituted harsher penalties for violations of federal consumer safety measures and created a public database of consumer product safety complaints.
What implications does the CPSIA have for businesses?
The Publicly Available Consumer Product Safety Information Database, which launched in March 2011, allows consumers to report product safety hazards. Some companies fear that negative consumer reports could be used as evidence during product liability trials, although a Maryland court blocked the publication of a report last October, ruling that the CPSC knew the content was inaccurate.
To combat any negative consumer reports, James Heller, chair of Cozen O’Connor’s products liability practice, advises companies to keep tabs on complaints. If a trend or a problem emerges, he says, companies should contact the customers in question and investigate their claims.
What steps should companies take to comply with the CPSIA?
Like the FSMA, the CPSIA has some companies worried about a possible rise in lawsuits courtesy of private litigants and plaintiffs attorneys. To ward off costly lawsuits, Paul Cereghini, executive managing partner of Bowman and Brooke, says companies should monitor CPSC regulatory activities related to product liability claims, keep tabs on the public information database at SaferProducts.gov to see whether product liability attorneys are attempting to initiate regulatory activity and take swift action at the first sign of regulatory activity or litigation.
Under the CPSIA, companies are also responsible for ensuring the safety of their supply chains. James Heller says businesses should require their suppliers to institute quality assurance/quality control testing and provide corresponding certificates of compliance, review the data from suppliers’ quality control testing and make visits to suppliers.