Turning Up the Heat: New US Food Regulations

The most dramatic change in US food safety since 1938 has arrived in the form of the Food Safety Modernisation Act, and for industry players and regulators alike, the prevention of food-borne illnesses will be their new speciality.

Where a reaction-based approach may have worked to stop the spread of disease and bacteria 70 years ago, the much more technologically advanced food supply chain of today means that outbreaks and endemics are much more difficult to stomach.

At present, 75% of all US seafood, 20% of vegetables and 50% of all fruit is imported to the country, bringing new pathogens and safety hazards. And, as the demographics of the country change, there is a larger percentage of people at increased risk of food-borne illness.

According to statistics compiled by the US Food and Drug Administration (FDA), 48 million Americans (around one in six) get sick each year due to food-borne illnesses. Around 128,000 of these people will be hospitalised and 3,000 will die.

With the help of the government and health watchdogs, the Food Safety Modernisation Act (FSMA) aims to amend this situation by shifting the industry focus towards killing the disease-causing bacteria at the source; i.e. the farm or processing plant, before it has the chance to sicken the consumer.

Work in progress

Signed as law by US President Barack Obama on January 4 this year, the FSMA has 50 new rules and several new guidance documents, many of which are yet to be implemented and finalised, so it may be too early to say what changes food companies have made to their food programmes.

Notable items that the industry is already focusing on, however, include producing safety plans, with preventive controls that the FDA can verify are being followed, and launching pilot programmes to test new traceability systems.  

The law also gives the FDA more influential powers, says Tony Corbo, a legislative representative for Food and Water Watch, a non-governmental organisation and consumer rights group, “The FDA now has the authority to mandate a food recall for products that it believes are adulterated, if a company refuses to recall the products voluntarily.

“FDA inspectors will also be empowered to have access to a company’s food production records if there is a belief that adulterated food may be entering into commerce. Up to now, FDA inspectors had access to those records only if there were a food-borne illness attributed to that food product.”

Importers must also have credible third-party certification to assure that the produce they are bringing into the US is safe, as International Food Protection TrainingInstitute (IFPTI) Executive Director Gerald Wojtala explains, “The law puts many more regulatory tools in the FDA toolbox. Most of the impact, however, will be from the leveraging of state and local government agencies though the Integrated Food Safety System.”

Enforcing the law

To ensure that the law is properly enforced, more frequent inspections are set to sort the compliant from the not-so-compliant food companies. The new legislation directs the FDA to inspect at least 600 foreign facilities and to double those inspections every year for the next five years.

It also states that all high risk domestic facilities must be inspected within five years of the law enactment and no less than every three years thereafter.

But, according to Corbo, this system comes as a major disappointment to Food and Water Watch, “Three years is a long time between inspections. Bad actors could still put contaminated products into commerce and not get caught until consumers get sick or die.”

“The Obama Administration and US Congress will need to provide the necessary resources so that the new law is fully implemented,” adds Corbo.

Once the law is fully implemented, Food and Water Watch will work to see that the law is enforced and make recommendations, should the law be deficient in any respect.

For now the organisation is participating in the public meetings held by the FDA and making sure the Obama Administration provides the necessary funding to implement the new law.

Meanwhile, the IFPTI is overseeing the implementation of a food protection training curriculum, which it is hoped will assure competency throughout all regulatory jurisdictions.

Wojtala says, “The national curriculum is designed to include new and existing courses offered by organisations within the food protection community, as well as IFPTI courses. It will also become the basis for measuring the effectiveness of third party auditors on an international basis for US imports.”

Compliance

There is a concern among small processors and farmers who believe that it will be costly to change their methods of operation to comply with the provisions of the new law, however, many manufacturers have been acting in accordance with the legislation for years.

According to Krista Eberle, director of food safety programmes for United Egg Producers and the Egg Safety Center, the FDA Egg Safety Rule covers most requirements in the FSMA that pertain to egg production.

“From the beginning, the US egg industry has supported the Egg Safety Rule and has worked with the FDA to ensure the food safety advancements would be maintained.”

“Through the various state assurance programmes, the hygiene protocols for washing and refrigerating eggs, for instance, were in place and effectively used well ahead of the ruling.”

The increasing consumer concern surrounding egg safety, however, has lead UEP to redesign its “5-Star” Egg Safety Program. The 2011 additions to the scheme include vaccination programmes, minimum requirements for feed management, traceability, and high laboratory standards.

In response to the law, technology providers and food agencies have developed new services and systems which will help food processors meet the standards expected of them.

Corbo predicts that microbial testing will play a major role in verifying the safety of food and says that the legislation calls for pilot programmes to test traceability systems, “We are certain that we will see different companies coming forward with products to help the food industry to comply with different aspects of the new law.”

Minnesota-base manufacturer MOCON will soon launch a bacterial testing system, GreenLight, which is designed to reduce the testing time and labour needed to determine aerobic bacterial counts in meat, poultry, seafood and dairy.

Miami law firm Sandler, Travis & Rosenberg PA is also in on the act and has developed a food safety monitoring service, which includes weekly news updates, monthly summaries from the FDA and instant alerts regarding time-sensitive announcements.

The Food Safety Modernisation Act is still new, but once fully implemented, it is set to dictate what kinds of investments companies will need to make their operations and systems fit the bill. Those companies that aren’t agreeable to change will have the country to answer to.