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FDA Update

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Low Acid Canned Food (LACF), Juice HACCP, Seafood HACCP under FDA Food Safety Modernization Act (FSMA)

 

The Food & Drug Administration (FDA) sent a constituent update regarding on how rules that implement the FDA Food Safety Modernization Act (FSMA) will affect a food producer covered by FDA’s regulations for low-acid canned foods, juice HACCP, or seafood HACCP.

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The FDA has published three guidances to help producers of food commodities covered by these earlier regulations understand which parts of the FSMA rules apply to them and how the FSMA rules may affect their operations.
FDA’s HACCP (Hazard Analysis and Critical Control Point) and Low-Acid Canned Foods (LACF) regulations were in place long before the FSMA rules became final.  FDA’s HACCP regulations for juice and seafood processors  require  processors to perform a hazard analysis and develop a HACCP plan to address biological, chemical, and physical hazards, monitor the conditions and practices, and make corrections as needed. FDA’s Low-acid canned foods regulation addresses biological hazards such as Clostridium botulinum unique to such foods, which include canned vegetables.
FSMA recognizes that FDA has previously-established regulations that are specific to seafood, juice, and LACF and so some exemptions have been made in the FSMA rules for these products. However, there are still some requirements in the FSMA regulations that apply to processors of the seafood, juice, and LACF products.
The new guidances aim to help industry identify these exemptions and understand the juice, seafood, and LACF regulations in connection with some of the new FSMA requirements. The overarching goal of many of the new FSMA  requirements is to reduce the number of foodborne illnesses attributed to the preventable contamination of FDA-regulated food products.

For More Information:

Low-Acid Canned Foods and FSMA

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm569789.htm
Juice HACCP and FSMA

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm569727.htm
Seafood HACCP and FSMA

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm569796.htm

 

 

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NEW Food Safety Plan Builder

 

If you need help with meeting the requirements of the Food Safety Modernization Act (FSMA) Final Rule for Preventative Controls for Human Food; look no further! The United States Food and Drug Administration (FDA) is releasing a new software tool to help owners and operators of food facilities create a food safety plan. The best part, it’s FREE!

The Food Safety Plan Builder (FSPB) is designed to help owners/operators of food facilities create and develop their food safety plans that are specific to their facilities and meet the requirements of the Current Food Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food Regulation (21 CFR Part 117)

The tool is strictly optional on the part of the user, this is not a requirement of FDA. The content of the Food Safety Plan Builder v.1.0 is consistent with the FDA’s current regulations and guidance.  Though the use of the tool does not mean that the safety plans, preventive controls, good manufacturing practices and/or other food safety procedures are automatically approved by FDA or comply with the FDA requirements.

Though the FSPB was primarily designed for the use by small manufactures, any size manufacturer can opt to use it.

The Food Safety Plan Builder (FSPB) 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

 

For system requirements, additional Regulations and Guidance: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm539791.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

For the Food Safety Plan Builder (FSPB) Download: https://www.accessdata.fda.gov/scripts/foodSafetyPlanBuilder/

Questions and further assistance on the FSPB can be directed to: FoodSafetyPlanBuilder@fda.hhs.gov