Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final, and compliance dates for some businesses begin in September 2016.

COVERED FACILITIES MUST ESTABLISH AND IMPLEMENT A FOOD SAFETY SYSTEM

  1. REQUIREMENTS FOR WRITTEN FOOD SAFETY PLAN THAT INCLUDES:
    • Hazard Analysis
    • Preventative Controls
    • Oversight and management of preventive controls
      • Monitoring
      • Corrective Actions & Corrections
      • Verification
  2. CURRENT GOOD MANUFACTURING PRACTICE CLARIFICATION & UPDATES:
    • 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

Compliance dates for businesses are staggered over several years after publication of the final rule (September 2015)

  1. Very small businesses (averaging less than $1 million per year (adjusted for inflation) in both annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale): September 2018.
    • Must supply records to support its status as a very small business by January 1, 2016.
  2. Small businesses (a business with fewer than 500 full-time equivalent employees): September 2017.
  3. 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): September 2018.
  4. All other businesses: September 2016.

If you have questions regarding how to comply, please contact info@register-fda.com (contact form) or visit the U.S. FDA’s Food Safety Modernization Act (FSMA) website.