Food Engineering

FDA's bigger budget request impacts FSMA

March 9, 2011
While the 33 percent budget increase may help implement the Food Safety Modernization Act, getting all the elements operational is a challenge.


The US FDA is requesting a budget of $4.3 billion to protect the public health as part of the President’s fiscal year (FY) 2012 budget, a 33 percent increase over the FDA-enacted budget for FY 2010. FY 2012 covers from October 1, 2011 to September 30, 2012. But the big question is: How does this affect the Food Safety Modernization Act (FSMA)? Of the increase, $324 million has been set aside for what the FDA terms the “Transforming Food Safety and Nutrition Initiative.” With the increase, FDA will begin to implement FSMA and also empower Americans to make healthier food choices. FDA will establish a prevention-focused system and leverage the work of the FDA’s state and local food safety partners. This, according to FDA, will result in a stronger, more reliable food safety system to protect American consumers.


Jim Cook, SGS.

Implementation of FSMA’s directives, however, may not be all that speedy. At first there will be no increase in inspections by FDA because it must first hire and/or train additional personnel to conduct inspections and manage the personnel doing the inspections, says Jim Cook, SGS food safety technologist, consumer testing services. Cook recently participated in an exclusive FE interview on the FSMA. SGS is a worldwide provider of inspection, verification, testing and certification services.

An alternative to FDA inspections would be states performing the legally mandated inspections, but the states would have to hire and/or train inspectors and manage the process, adds Cook. Another option would be the FDA’s acceptance of certified inspections by a third party using, for example, GFSI (Global Food Safety Initiative)-benchmarked standard audits.

FSMA has brought with it several questions regarding US processors’ compliance with Codex Alimentarius, especially if food is imported from the EU or exported to the members of the EU. The Codex Alimentarius Commission was created in 1963 by the United Nations’ FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Program.

“Codex is strictly a voluntary program and does not directly affect the laws in the US, EU or any other country,” says Cook. The US, as all countries, has the right to except in part or in whole the standards set by Codex, he adds. In some areas, Codex is stricter than what is allowed in the US and, in some areas, less strict. Here is an example of a more restrictive situation: Recently a supplier wanted to know if it could add methylcellulose to canned mandarin oranges and sell them in the US. Under US (FDA) law, methylcellulose is a GRAS (generally recognized as safe) substance and can be used in canned mandarin oranges, but under the Codex standards methylcellulose is not allowed in canned mandarin oranges, according to Cook. A less restrictive example follows. The Codex standard for allowable tin in canned fruit juice is not more than 250 ppm while the US FDA standard is not more than 230 ppm.

“USDA and US FDA worked closely with the other countries to formulate these Codex Standards,” says Cook. “Codex Standards will only increase the quality and safety of food in a country if the standard is adopted in full by that country.”

Under FSMA, electronic track-and-trace records will become crucial to safer food. While the use of RFID tags has helped make track and trace easier, it hasn’t been a total solution, partly because smaller processors can’t afford the necessary computer-based system, says Cook. And while FDA has a reporting system for contaminated food, it’s not the ultimate solution either. A cloud-based computer database system could serve the developed world that has access to computers, allowing vital information on products and shipments to be uploaded. But unfortunately, in much of the world where produce is grown and shipped, computers are nonexistent, and the cloud solution is terribly impractical, says Cook. “Under the FSMA, even the simple FDA [reporting] system will explode with information, with more personnel being required to report information on contaminants and recalls,” he adds.

While there has been considerable progress, we are still a long way off-from even having a domestic government-sponsored track and trace program, says Cook.