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FSMA Part 1: What You Need to Know

FSMA WHAT YOU NEED TO KNOW: Part 1

This is a first in a series of posts dedicated to the subject of the FDA Food Safety Modernization Act (FSMA) and how it relates to coffee and tea.  Overall, our goal is to help our customers better understand their responsibility in relation to this Act.

  • The FDA Food Safety Modernization Act (FSMA) is the most sweeping reform of our food safety laws in over 70 years. This act became a law on January 4, 2011.  Overall, it aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.
  • FSMA requires that all companies that deal with consumable food items create a Food Safety Plan, with required compliance dates for separate parts of the plan.

WHEN DO I HAVE TO BE COMPLIANT?

Preventive Controls for Human Food (see below Food Safety Plan)

  • Businesses over 500 persons Sept. 19, 2016
  • Small Business under 500 persons Sept. 18, 2017
  • Very Small Businesses less than $1 million in sales Sept. 17, 2018

Supply Chain Program

  • Businesses over 500 persons Sept. 19, 2018
  • Small Business under 500 persons TBA
  • Very Small Businesses less than $1 million in sales TBA

Royal New York's food safety plan guidelines

A FOOD SAFETY PLAN CONSISTS OF 

REQUIRED

  1. Hazard Analysis: Biological, Chemical, Physical and Economical
  2. Preventive Controls: Process, food allergen, sanitation, supply chain and other.
  3. Procedures for monitoring, corrective action and verification.
  4. Recall Plan

RECOMMENDED TO BE INCLUDED

  1. Facility overview and Food Safety Team
  2. Product description
  3. Flow diagram
  4. Process description

WHAT IS THE FIRST STEP?

Most companies will want to have someone on their staff trained to be a PCQI (Preventive Controls Qualified Individual).

  • A PCQI must develop (or oversee the development of) the Food Safety Plan.  Overall, a PCQI is a person with the education, training, or experience (or a combination of these) to develop and apply a food safety system.  This person can be qualified through job experience or by completing training equivalent to the standardized curriculum recognized as adequate by FDA (e.g., the Food Safety Preventive Controls Alliance (FSPCA) training).
  • Responsible to perform and oversee
    • Preparation of the Food Safety Plan
    • Validation of the Preventive Controls and provide Corrective Actions when necessary
    • Records Review
    • Reanalysis of the Food Safety Plan
  • The PCQI does not need to be an employee of the facility.  However, for cost effectiveness, we highly recommend it. Please visit https://www.ifsh.iit.edu/fspca for more information.

USEFUL LINKS

Key Requirements of FSMA: 

https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Key_Requirements

Compliance Date Extensions and Clarifications for FSMA Final Rules:  

 https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm517545.htm

Frequently Asked Questions on FSMA: 

https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247559.htm

This Blog is made available by Royal New York for educational purposes only.  It is intended to give general information and a general understanding of some food safety requirements.  However, it is not provided for any specific food safety circumstance.  Overall, this Blog should not be used as a substitute for competent and qualified food safety guidance from a food safety professional.