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Katie Jurgenson 1/25/2013 The FDA Food Safety Modernization Act was signed into law in 2011 by President Obama. Its purpose is to ensure the U.S food supply is safe by enabling the FDA to focus more on preventing contamination rather than reacting to problems after they occur. Prevention is the core principle of the FDA Food Safety Modernization Act. FSMA is the most extreme reform of FDA’s food safety authority in more than 70 years. This act allows the FDA more authority in protecting consumers and promoting public health. As of January 4, 2013 the FDA has issued two major FSMA rules. A total of five are in the works. The first two have been proposed and published for public comment: Preventive Controls for Human Food: This rule sets safety requirements for facilities that process, package or store food for people. The rule will require that food facilities implement “preventive controls,” a science-based set of measures intended to prevent foodborne illness. • Produce Safety: The food-safety law requires that science-based standards be set for the production and harvesting of fruits and vegetables, and FDA is proposing such standards for growing, harvesting, packing, and holding produce on farms. •

Controls for Human Food Under the new preventive control rules, most human food facilities would be required to have a written plan that would specify the steps that will be put in place to minimize or prevent hazards likely to occur in food such as pathogens and allergens, and the actions that will be taken when problems arise. Produce Safety These standards include requirements addressing major areas specific to agriculture that can be the conduit for contaminants: • • • • •

Irrigation and other agricultural water Farm worker hygiene Manure and other additions to the soil Intrusion of animals in the growing fields. Sanitation conditions affecting buildings, equipment and tools

The proposed rule also includes additional provisions applicable to the growing, harvesting and packing of sprouts, which are more vulnerable in their growing environment to harmful bacteria. The Other Three Rules

The rules still to come are: Foreign Supplier Verification for Importers: This program will require importers to verify that foreign suppliers are following procedures that provide the same level of health protection as that required of domestic food producers. • Accredited Third Party Certification: The accreditation of third-party auditors would help ensure that food producers in other countries comply with U.S. food safety laws. • Preventive Controls for Animal Food: This is the implementation of preventive controls at animal food facilities that are similar to those proposed for human food. •

Putting FSMA to Work Under the new food safety law, FDA will be issuing a number of rules including a preventive controls rule in food facilities, a foreign supplier verification rule, and a produce safety rule. In some instances, FDA holds public meetings to give all interested parties an opportunity to participate and provide comments even before proposing a rule. . Step 1: FDA Proposes a Rule and Requests Comments FDA issues a proposed rule it is published in the Federal Register (FR) so that members of the public can review it and send their comments to us. The public is given a period of time (30-90 days) to submit their comments. If FDA determines that it does not have enough information to issue a proposed rule, the agency may seek more information. Step 2: FDA Considers Your Comments and Issues a Final Rule FDA considers the comments received during the comment period on the proposed rule before issuing a final rule. Step 3: Companies Comply with the Rule Based on the “Effective Date” When a final rule is published, it may have a future effective or compliance; sometimes this has been established in the law. The amount of time before a rule goes into effect varies.


CRD 4.3