Washington, D.C.—A pair of proposed rules has been introduced by the U.S. Food and Drug Administration (FDA), both of which are aimed at the prevention of foodborne illness. One requires a formal plan from foreign and domestic food facilities for protecting their products from foodborne illnesses. The other involves enforceable, science- and risk-based standards for the safe production and harvesting of fruits and vegetables.

These rules are part of the implementation of the FDA Food Safety Modernization Act (FSMA) enacted in 2011, and comments will be accepted from the public for a period of 120 days that began on January 4. The title of the first proposed rule is “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.” Makers of food to be sold in the United States, including those abroad, must develop and submit a written plan for preventing foodborne illness under this rule. They would also be required to have a plan of action in case any problems do arise.

FDA stated that it would expect many manufacturers to be in compliance with this rule one year after it is made final, but that small and very small businesses would be granted extra time. Compliance with most of the requirements of the second rule on produce safety is expected of larger farms within 26 months after the final rule is published. The same time extensions would apply to small and very small farms, and all farms would be allowed additional time to align themselves with certain water quality requirements.

“We know one-size-fits-all rules won’t work. We’ve worked to develop proposed regulations that can be both effective and practical across today’s diverse food system,” said Michael R. Taylor, deputy commissioner for foods and veterinary medicine at FDA.

According to FDA, the proposed rules come after an extensive outreach effort by the agency, including FDA staff tours of farms and facilities nationwide, along with hundreds of meetings with other stakeholders. The agency describes the burden of foodborne illness as substantial, with one in six Americans suffering from one every year. This includes almost 130,000 hospitalizations and 3,000 deaths.

FDA said that more rules focused on prevention are set to follow, as required by FSMA. These additional rules will include new requirements for food importers to verify that products grown or processes abroad are as safe as domestically produced food. There will also be new, tougher accreditation standards for foreign third party food safety auditors.

Published in WholeFoods Magazine, February 2013