The Food Safety Modernization Act (FSMA) of 2011 was signed into law by President Obama in January 2011. Some of the statutes in that law are going into effect in 2012. The government has already completed some tasks:
- A consumer-friendly, easy-to-search web site for product recalls was launched.
- The Coordinated Outbreak Response and Evaluation (CORE), dedicated to rapid response of foodborne illness outbreaks was created.
- A new agency, the Food Safety Preventive Controls Alliance, was established to train companies about the new rules and regulations.
- Draft guidances for many new regulations were issued for the public’s comment.
- Final guidance on egg safety and other products were published.
This law was the first significant new legislation on food regulations and safety since the Food, Drug and Cosmetic Act of 1938. The FSMA focuses on prevention, since about 48,000,000 Americans contract food poisoning, 120,000 are hospitalized for serious foodborne illness, and 3,000 die of food poisoning every year. The top five pathogens (Camplylobacter, Salmonella, Listeria monocytogenes, Toxoplasma gondii, and norovirus) cause $12.7 billion in economic loss every year.
These new laws and regulations take time to put into effect. Final rules are not issued until input has been received from producers, distributors, processors, and the general public. And it takes time for firms to comply with the new regulations.
- The FDA will establish science-based standards for producing and harvesting fruits and vegetables. The identified hazards will include man-made risks and natural hazards, such as bacteria present in the soil and water, and pollution and run-off from animal farms and animal intrusion near growing sites.
- The agency will employ about 2,000 additional inspectors, given that inspections will be occurring more frequently.
- The FDA can issue mandatory food recalls if a suspected outbreak is occurring. Before this new law, the government could only issue voluntary recalls, except for contaminated infant formula.
- Adulterated and misbranded food can be confiscated while still in distribution channels, before it reaches the consumer.
- The FDA must create new national food safety standards for growing, harvesting, and transporting produce. Most people think of meat, poultry, seafood, and eggs as primary sources of foodborne illness, but produce such as Jensen Farms cantaloupe caused the largest deadly foodborne illness outbreak in this country in almost 100 years. Produce has always had the potential to be contaminated, as evidenced by the Avon Heights spinach recall, the Green Valley alfalfa sprout recall, and the Cal Fresco jalapeno and serrano chili recall just in the past few weeks.
- Companies that grow and sell produce must keep track of where their products are sold with an electronic tracking system, so public health officials can more quickly discover where contaminated food has been shipped and find its source.
- Food processing and manufacturing companies must take pre-emptive action to prevent contamination, such as creating written safety plans by July 2012.
- Facilities and companies must develop safety protocols such as Hazard Analysis Critical Control Points (HACCP) Systems. These plans must be documented and updated every two years. HACCP plans are already required by the FDA for seafood and juice, and by the USDA for meat, poultry, and eggs. These plans will be required of all facilities and companies.
- Companies which handle higher-risk foods could be told to expand their record-keeping requirements.
- Companies must share their food safety plans with the FDA if asked.
- If the company changes suppliers, processes, or ingredients, they must update and document their entire food safety plan.
- The frequency of FDA on-site inspections is going to increase from one inspection every five to ten years to one inspection every three years.
- The FDA is going to create an Accredited Third-Party Certification Program for auditors to assist the FDA in overseeing new standards and laws.
- The FDA is going to have broader oversight over imported foods. Since imported fruits and vegetables make up 60% of the fresh produce sold in this country, it’s important that these foods meet the same safety standards as produce grown in this country.
- Importers must establish a risk-based Foreign Supplier Verification Program to document preventive control systems to ensure food is safe.
- Importers must make sure that all food entering the country meets FDA safety standards under the Food, Drug, and Cosmetic Act.
- The FDA can conduct on-site inspections of overseas facilities that export foods to the United States.
- Companies that refuse inspections can be banned from exporting food to the United States. Any facility in the United States or elsewhere can have its registration suspended if the food it produces, processes, packs, receives, or holds “presents a serious health hazard”.
This is not meant as a complete list of the FSMA, but highlights the main components of the new law. While these measures will hopefully begin preventing outbreaks of foodborne illness before they start, the consumer has some power in this equation.
But sometimes, no matter what you do, food poisoning will occur, especially if ready-to-eat foods such as lunch meat contaminated with Listeria or spinach contaminated with E. coli are put on the market. And it’s important to remember that it’s against the law to sell food contaminated with some bacteria classified as adulterants.