REGULATORY-NEWS

Free FSMA Compliant Food Safety Plan Tool

The FDA has created a Windows application meant to run on a PC or laptop that will guide you step-by-step through the process of creating a safety plan for your food business, and they’ve now just released it for download. According to the website:

The U.S. Food and Drug Administration’s (FDA) Food Safety Plan Builder (FSPB) is a tool designed to assist owners/operators of food facilities with the development of food safety plans that are specific to their facilities and meet the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117).

Use of this tool is strictly optional on the part of the user. FDA is not requiring use of this tool to develop a facility’s food safety plan. Although the content of the Food Safety Plan Builder v. 1.0 is consistent with the FDA’s existing guidance and regulations, use of the Food Safety Plan Builder by owners and operators of food facilities does not mean that their food safety plan, preventive controls, good manufacturing practices and other food safety procedures are approved by FDA or comply with FDA requirements.

The Food Safety Plan Builder guides the user through the following sections:

  • Facility Information
  • Preliminary Steps
  • Good Manufacturing Practices (GMP) & Prerequisite Programs
  • Hazard Analysis & Preventive Controls Determination
  • Process Preventive Controls
  • Food Allergen Preventive Controls
  • Sanitation Preventive Controls
  • Supply-Chain Preventive Controls
  • Recall Plan
  • Reanalysis of Food Safety Plan
  • Food Safety Plan Report
  • Signature
  • Recordkeeping Procedures
  • Important Contacts
  • Supporting Documents

If you have additional questions or need more information, please email FoodSafetyPlanBuilder@fda.hhs.gov

It’s Coming! FSMA Decoded So Far…

US Food and Drug AdministrationDuring a salmonella outbreak of 2008 and 2009 nine people died, 166 were hospitalized and more than 700 fell ill. Authorities ultimately traced the contamination of Salmonella Typhimurium back to peanut products manufactured in a Texas plant owned by the Peanut Corporation of America. According to the US CDC an estimated 48 million people each year are affected by food borne illnesses resulting in over 100,000 hospitalization and 3,000 deaths. In this one case, however, there were several factors that caught the general public’s attention:

  • Illnesses were caused all over the US without apparent patterns at first;
  • People died from exposure in nursing homes and other medical facilities;
  • Many different products across different company’s products and brands were found to be contaminated, both commercial and institutional;
  • Ultimately the media found that the peanut processing plant had been operating legally in Texas without EVER having been inspected by state or federal food safety organizations.

As a result of the tremendous publicity and outrage of this embarrassing outbreak a White House Food Safety Working Group was formed to investigate this specific failure in the US food safety network. The result was the Food Safety Modernization Act (FSMA) passed by Congress and to be implemented by the US Food and Drug Administration (FDA).
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FDA Draft Report on Soft-Ripened Cheese Production

The Cheese Reporter reports in their February 8th issue that the US Food and Drug Administration (FDA), working in conjunction with Health Canada, has released a draft report on their risk assessment of soft-ripened cheese production using pasteurized and raw milk specifically for L. monocytogenes (Listeria). This risk assessment will be used by FDA risk managers to inform their food-safety decisions as they re-evaluate the FDA rules around cheese production.

According to the assessment raw milk cheese presents a higher risk of Listeria contamination than pasteurized milk cheese.

A major finding was that although testing bulk milk used to make raw milk cheese DID reduce the risk significantly, it did NOT reduce the risk as much as testing raw milk cheese lots (which is the current Canadian requirement for raw milk cheeses).

This draft assessment is submitted for comments beginning February 4th, 2013 for 75 days. Comments may be submitted to www.regulations.gov. The docket number is FDA-2012-N-1182