On Friday, Jan. 4, the FDA issued two sweeping proposed food safety regulations in the form of new: (1) preventive control provisions through amended and expanded Current Good Manufacturing Practices for human food processing operations; and (2) growing, packing, handling, and holding regulations for produce (fruits and vegetables that are consumed raw) operations. Both proposed regulations are authorized by the Food Safety Modernization Act passed in early 2011. They are the most significant proposed food safety changes in decades. The changes would apply to approximately 80 percent of the food consumed in the United States.
In each case, industry members and other stakeholders have until May 16, 2013 to submit comments to the proposed regulations, including proposed amendments and alternatives. As to record-keeping requirements, the industry has until Feb. 15 to respond. The regulation will likely be implemented sometime in 2014.
The FDA estimates that large farms will incur $30,000 in new annual costs for complying with these broad new mandates. In addition, the FDA will need $1.4 billion in new annual revenue to monitor, verify, and enforce the new regulations. The funding sources for these new costs have not been identified and are likely to be the source of political dispute especially in the ongoing fight over federal budget deficits.
The USDA, which is not involved in these proposed regulations, regulates food safety for beef, poultry, and many, but not all, egg issues (for instance, with these proposed regulations the FDA will be expanding its food safety regulation of all significant salmonella risk products including eggs).
Specifically, the proposed rule for Good Manufacturing practices would establish, for those facilities now required to register under the FDA’s existing Public Health Safety and Bioterrorism program, requirements for preventive controls for facilities where hazards are reasonably likely to occur, including requirements for:
- A written food safety plan;
- Hazard analysis (individualized science-based risk analysis based upon the proposed regulations, in-process industry guidance, and expert evaluation);
- Preventive controls for hazards that are reasonably likely to occur;
- Monitoring;
- Corrective actions;
- Verification;
- Associated records (the record-keeping requirements are significant); and
- Identifying and training a qualified individual at each facility to oversee compliance.
The regulations propose a number of exemptions or modified regulations for small business facilities and on-farm operations with less than $250,000, $500,000, or $1 million in annual sales, especially where a majority of the sales are to local end-users (on-farm facilities with fewer than 500 employees are also exempt). There are also exemptions for many products already subject to specific FDA regulation such as most alcoholic beverages; and many intermediate storage facilities.
Turning to the produce regulations, the FDA seeks to “minimize the risk of serious adverse health consequences or death” through standards “reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards.”
Like the processing operation regulations, the produce regulations are designed to be science-based risk assessments focusing on individualized qualitative risk assessment and biological hazards, considering different risks of different commodities and growing practices, requiring farm-specific safety plans and applying regulations to foreign farms, and requiring periodic product testing. Significantly, the proposed regulations would address health and hygiene of human involvement with these operations and also impacts of both humans and wild and domesticated animals on biological soil. The last requirement could add significant costs to growing operations in order to comply with requirements (e.g., toilets for workers and fences to prevent wildlife incursion) designed to prevent or reduce the risk of pathogens such as e-coli from entering the produce stream of commerce.
The produce regulations would not apply to very small operations (food value of product sold averages less than $25,000 over the past three years) and would be modified for operations with food value sales of less than $500,000 where such sales are overwhelmingly to end-users locally; moreover, the proposed regulations “would not apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity.” In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance would be eligible for exemption from the” regulations.
Additional proposed regulations for animal food operations and intentional food contamination (e.g., through terrorism) will be issued separately.