FDA creates new food-testing regulations

By ADARSHA MALLA

Nearly five years after Congress passed the Food and Drug Administration (FDA) Food Safety Modernization Act of 2010 (FSMA), giving the FDA more influence on the regulation of food growth and processing, the federal government has finalized food safety rules that will force producers to focus on preventing food contamination rather than just reacting to it.

Some consider the passing of the FSMA to be the most significant update to the FDA’s food regulatory authority in 70 years. However, there are concerns about the speed at which the directives are being introduced. While Sandra Eskin, director of food safety at Pew Charitable Trusts, is optimistic about the new regulations, some consumer advocates criticized how long it took the government to implement the FSMA.

The new rules, which were originally promoted as a top priority of the Obama administration, ran into delays and did not make a court-ordered deadline after advocacy groups sued the government. The final government safety rules were released on Sept. 17 in the wake of deadly foodborne illness outbreaks across the United States, which were linked to ice cream, caramel apples, peanuts and cantaloupes.

According to the Centers for Disease Control and Prevention (CDC), approximately 48 million people, or one out of every six Americans, get sick each year from foodborne illnesses. About 128,000 people are hospitalized and 3,000 die annually.

Today nearly half of fresh fruits and one-fifth of vegetables in the U.S. are imported, a relatively new shift in the food industry that has created quality control issues.

The new food safety rules, which apply to foods for humans, pets and livestock, require that food manufacturers compose detailed food safety plans that demonstrate how they will maintain sanitation standards in their food development and processing facilities. In addition to creating a safety plan for their facilities, food plants will have to keep a safety activity log where they will record safety mishaps and protocol violations. These written records will be subject to review by FDA officials at any time.

This represents a significant change from earlier regulations. Previously, food makers were not required to hand over records to the FDA. Thus, the FDA would only know to investigate food plants after their products made people sick, according to Eskin.

In the Blue Bell ice cream outbreak, which occurred earlier this year, FDA inspectors discovered a significant number of violations at a Blue Bell plant including dirty equipment, inadequate food storage, food held at improper temperatures and employees not washing hands appropriately. Three recent listeria deaths were linked to ice cream produced by the company.

Similarly, a 2011 listeria outbreak linked to Colorado cantaloupe killed 30 people. The FDA, which investigated the plant after the illness broke out, said that old hard-to-clean equipment and improper cooling were partially responsible for the illnesses. Michael Taylor, deputy commissioner for food and veterinary medicine at the FDA, said that most food-safety breaches are actually preventable.

“[The FSMA provides] new enforcement tools that will create more accountability,” Taylor told The Wall Street Journal.

The part of the FSMA that is considered the most controversial includes regulations that are set to be proposed in October. These rules create new standards for farmers growing produce. The rules would require farmers to take new precautions against contamination, ensuring that workers' hands are washed, irrigation water is clean and animals stay out of wild fields.

The FDA claimed that it worked with stakeholders in the agricultural sector to set these standards, but many in the industry say the standards could harm agricultural businesses. The finalized rules will go into effect for large food companies next year and smaller companies will have more time to comply. All food companies will be required to abide by the new rules by 2018.