About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from food borne diseases, according to recent data from the Centers for Disease Control and Prevention. The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, 2011, enables FDA to better protect public health by strengthening the food safety system.
As a key element of this preventive approach, FDA was mandated under FSMA to establish science-based, minimum standards for the safe growing, harvesting, packing, and holding of produce on farms to minimize contamination that could cause serious adverse health consequences or death.
The food safety law passed by Congress on December 21, 2010 aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. FDA Commissioner Margaret A. Hamburg, M.D. issued a written statement shortly after passage. Key facts about this legislation are presented below.
The FSMA is now final, and compliance dates for some businesses begin in September 2016. According to the FDA, this final rule is the product of an unprecedented level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local and tribal regulatory counterparts, academia, and other stakeholders.
Here are five important points that every cold chain shipper should know about the FMSA:
- There are new hazards analysis and risk-based prevention controls. Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. The rule sets requirements for a written food safety plan that includes: Hazard analysis, preventative controls, monitoring, corrective actions/corrections, and verification. The latter, for example, includes validating with scientific evidence that a preventive control is capable of effectively controlling an identified hazard; calibration (or accuracy checks) of process monitoring and verification instruments such as thermometers, and reviewing records to verify that monitoring and corrective actions (if necessary) are being conducted.
- Farms aren’t subject to preventive rules control. The EPA’s definition of a “farm” includes two types of farm operations, and operations defined as farms are not subject to the preventive controls rule. A primary production farm is devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. A secondary activities farm isn’t located on a primary farm, but it is devoted to harvesting, packing, and/or holding raw agricultural commodities.
- Some companies will need risk-based supply chain programs. The FSMA mandates that a manufacturing/processing facility have a risk-based supply chain program for those raw materials and other ingredients for which it has identified a hazard requiring a supply-chain applied control. Manufacturing/processing facilities that control a hazard using preventive controls, for example, or that follow requirements applicable when relying on a customer to controls hazards, need not have a supply-chain program for that hazard.
- Employee training will be mandatory. Management is required to ensure that all employees who manufacture, process, pack, or hold food are qualified to perform their assigned duties. Such employees must have the necessary combination of education, training, and/or experience necessary to manufacture, process, pack, or hold clean and safe food. Individuals must receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene.
- Compliance dates for businesses are staggered over several years after publication of the final rule. Here are the deadlines:
- Very small businesses (averaging less than $1 million per year in both annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale): Three years
- Businesses subject to the Pasteurized Milk Ordinance (compliance dates extended to allow time for changes to the PMO safety standards that incorporate the requirements of this preventive controls rule): Three years
- Small businesses (a business with fewer than 500 full-time equivalent employees): Two years
- All other businesses: One year
Click here to learn more about the FSMA.