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Rule 1

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. 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.
  1. 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.
  1. 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!
  1. 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