FDA has released proposed rules on preventive controls for human food. The rule requires firms that manufacture, process, pack, or hold human food to have written plans to identify hazards, specify steps to minimize or prevent those hazards, identify monitoring procedures, record results, and specify corrective action. The proposed rule published on January 16, 2013. Comments are therefore due May 16, 2013. The rule is available for review and comment at www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm.
The rule has two major features. First, it contains new provisions requiring hazard analysis and risk-based preventive controls. Second, it would revise the existing Current Good Manufacturing Practice (CGMP) requirements found in 21 CFR Part 110. The new requirements and modified CGMPs would appear in a new 21 CRF Part 117.
Hazard Analysis and Risk-Based Preventive Controls. A covered facility would be required to comply with hazard analysis and risk-based preventive controls. Firms could develop preventive controls that fit their products and operations as long as they are adequate to significantly minimize or prevent all reasonably likely food safety hazards. Each covered facility would be required to prepare and implement a written food safety plan that includes:
Hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held.
Preventive controls to ensure that reasonably likely hazards will be significantly minimized or prevented.
Monitoring procedures to ensure that preventive controls are consistently performed. Records must be kept to document the monitoring.
Corrective actions to be used if preventive controls are not effective. Facilities would be required to correct problems and minimize the likelihood of reoccurrence, evaluate the food for safety, and prevent affected food from entering commerce.
Verification to ensure preventive controls are effective and consistently implemented and reassessment of the food safety plan at least every three years.
Recordkeeping including a written food safety plan, hazard analysis, and records of preventive controls, monitoring, corrective actions, and verification.
Revisions to Current Good Manufacturing Practices. The CGMP regulation clarifies existing CGMP provisions requiring protection against cross-contact of food by allergens. FDA is requesting comment on whether it should mandate training for employees and supervisors, and whether it should require provisions such as cleaning non-food-contact surfaces of equipment to protect against contamination of food and food-contact surfaces.
FDA has recognized that small and very small businesses may need more time to comply with the requirements, and has adjusted compliance dates are proposed.
Small Businesses. A business that employs fewer than 500 persons and that does not qualify for an exemption would have to comply two years after publication.
Very Small Businesses. Three options are being proposed: less than $250,000; less than $500,000; and less than $1,000,000 in total annual sales of food. Very small businesses, subject to modified requirements for preventive controls, would have to comply three years after publication. • Other Businesses. A business that does not qualify for an exemption would have to comply one year after publication of the final rule.
The proposed rule is aimed at reducing the public health burden of foodborne illness. FDA estimates that close to 1 million illnesses each year are attributable to food that would fall under the scope of this proposed rule. The economic cost of illnesses avoided is $2 billion a year. The proposed rule has a first-year cost to industry of $701 million and an annualized cost of $472 million, and would cover an estimated 97,600 domestic facilities. After publication of the final rule, FDA will publish a guidance document to help businesses, particularly small businesses, comply.