Preventive Controls for Human Food Rule
Covered facilities that operate under the Preventive Controls for Human Food should be aware of the following changes outlined in the Final Rule:
- 1. “Establish and implement a food safety system that includes an analysis on hazards and risk based preventative controls”
- This requirement covers: hazard analysis, preventative controls and oversight and management of preventative controls.
- 2. “The Definition of a ‘farm’ is clarified to cover two types of farm operations. Operations defined as farms are not subject to the preventative controls rule.”
- Farms are differentiated into two different categories: Primary Production Farms and Secondary Activities Farms. A Secondary Activities Farm performs duties such as packaging and/or holding food that comes from the Primary Production Farm. Secondary Activities Farms must be majority owned by the Primary Production Farm.
- 3. “Supply-chain program is more flexible, with separate compliance dates established.”
- Speak with one of our representatives to see how this effects your company!
- 4. “Current Good Manufacturing Practices (CGMPs) are updated and clarified.”
- Employees must have necessary training, schooling and/or experience to hold, pack, process or manufacture food. Management must ensure that employees are performing their assigned duties.
Compliance Dates:
September 17, 2018
- Very small businesses (averaging less than $1 million per year)
- Businesses subject to the Pasteurized Milk Ordinance
September 18, 2017
- Small businesses
(a business with fewer than 500 full-time employees)
September 19, 2016
- All other businesses
Compliance Dates for Receiving Facilities:
- Receiving facility is a small business and its supplier will not be subject to the human preventive controls rule or the produce safety rule: Two years after September 17, 2015.
- Receiving facility is a small business and its supplier will be subject to the human preventive controls rule or the produce safety rule: Two years or six months after September 17, 2015 the supplier is required to comply with the applicable rule, whichever is later.
- Receiving facility is not a small or very small business and its supplier will not be subject to the human preventive controls rule or the produce safety rule: 18 months after September 17, 2015.
- Receiving facility is not a small or very small business and its supplier will be subject to the human preventive controls rule or the produce safety rule: Six months after September 17, 2015 the supplier is required to comply with the applicable rule.
Source: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm
