Provisions within the Food Safety Modernization Act aim to prevent future outbreaks of the kinds of food-borne illnesses seen in recent years, such as those involving salmonella in spinach and jalapeno peppers (initially blamed on tomatoes), and contaminated peanuts.
Food-borne diseases cause approximately 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States each year, according to recent data from the Centers for Disease Control and Prevention.
The legislation requires food facilities to comply with stricter “science-based” standards for the safe harvesting of fruits and vegetables, and requires facilities to produce food safety plans and enhance record keeping.
Expanded FDA powers will give the government new power to order a recall if a company fails to do so voluntarily. Until now, the FDA relied on the media to raise public alarm during a disease outbreak, which in most cases compelled companies to issue recalls to protect their brand credibility.
Inspections are also set to increase. High-risk facilities must receive an inspection within the first five years, and then every three years after that. Imported food safety has also been boosted, with the FDA ordered to inspect 600 foreign food facilities the first year, and then doubling the number of foreign inspections annually for five years.
“This law helps us take the critical steps toward strengthening the food safety system that is vital to the health and security of the American people,” said FDA Commissioner Margaret A. Hamburg, M.D. in a statement.
But Hamburg also expressed concerns over the legislation’s lack of sufficient funding to cover the costs of additional inspections, in addition to the recording and monitoring of producers.
The legislation says nothing specific about funding for more FDA inspectors—Congress still needs to approve any funding increases. The Congressional Budget Office estimates the legislation will increase the cost of discretionary spending by $1.4 billion over the next five years.
Amendment Debate
The legislation passed with significant majorities in both Houses, and the president has indicated he will sign it, but its final debate centered on a controversial amendment proposed by Sen. Kay Hagan (D-N.C.) and Sen. Jon Tester (D-Mont.).
The Tester-Hagan amendment exempted from new regulations small producers primarily selling directly to consumers, hotels, and restaurants.
Small farmers across the country rallied behind the amendment, claiming they were already sufficiently regulated. Food safety concerns involving small farms were different from large operations, and easier for owners to deal with personally, they argued.
The chief concern among small farmers was that the new rules disproportionately affected them, and could drive them out of business.
"We successfully fought for our farmers. Jobs are my number one priority, and this amendment protects jobs in our agriculture industry,” said Hagan in a statement.
The amendment applies to producers grossing under $500,000.
Of the 2.2 million farms in the United States, just 125,000 farms produce 70 percent of the nation’s food, according to a U.S. Department of Agriculture census. That leaves over 2 million small farms—700,000 of which are considered micro-farms, with annual sales less than $1,000.
The leading U.S. trade association for the large fruit and vegetable producers issued a statement of “mixed feelings” on the new legislation. United Fresh Produce officially withdrew its support of the reforms over the Tester-Hagan amendment.
“The good in this bill … is still accompanied by the bad,” said United Fresh Senior Vice President of Public Policy Robert Guenther.
Despite acknowledging that passage of the act is a “watershed moment for food safety in America,” Guenther said loopholes created by inclusion of the amendment could “come back to haunt Congress, public health agencies, and even those who thought they would benefit from the food safety exemptions.”
Within the amendment the FDA is allowed to withdraw an exemption if the farm is “directly linked” to a food-borne illness disease outbreak, or if it is deemed necessary to do so to mitigate a potential outbreak.
