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© 2019 by Continuum Partner Consulting

Food Safety Modernization Act (FSMA)

The Food Safety Modernization Act (FSMA), signed into law by President Obama in 2011, was a comprehensive and systematic overhaul of the U.S. food safety regulations in over 70 years transforming the nation’s food safety system by shifting the focus from responding to food-borne illness to preventing it.  FSMA grants the FDA new authorities to regulate the way foods are grown, harvested and processed, and enables FDA to better protect public health by strengthening the food safety system. 


The food industries across the entire food supply chain from Farm-to-Table are held responsible for ensuring that human and animal foods sold in the United States must meet the food safety standards from growing, harvesting, processing, packaging, importing, transporting, storing, to distributing.  Both domestic and foreign companies are mandated to have comprehensive and preventive controls across the supply chain. 

The FDA has published 7 fundamental regulations under FSMA:

* Voluntary program, applied to importers who want to join the fee-based Voluntary Qualified Importer Program and certification bodies.

FSMA Services

FDA Facility Registration and US Agent

The FDA Food Safety Modernization Act (FSMA) requires domestic and foreign facilities to submit certain information to FDA and to renew registrations every other year.  If you are the owner, operator, or agent in charge of either a domestic or foreign facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States, you are required to register with the FDA, unless an exemption applies.  CPC offers a facility registration certificate should your customers request one.


Need help to register your facility?

A foreign facility must use a U.S. Agent, who has a place of business or residence in the United States and be physically present in the United States to complete facility registration with the FDA.  A U.S. agent may not be in the form of a mailbox, answering machine or service, or other places where an individual acting as the foreign facility's agent is not physically present. 


As your U.S. Agent, CPC will act as a communications link between the FDA and your facility for both routine and emergency communications, represent your facility to the FDA, update the FDA when information pertained to facility registration changes, provide guidance for FDA regulatory compliance.

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Foreign Supplier Verification Program (FSVP)

FSVP, a regulation under FSMA that holds the U.S. food importers responsible for food safety of imported foods,  requires food importers covered by the rule must verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling. 


FSMA Readiness Assessment

Want to learn which FSMA rules your business is subject to? Are your current food quality and safety system FSMA compliant?  CPC will evaluate your business operation against all applicable FSMA regulations, conduct Gap Analysis, develop a practical and effective plan and help implementation of the plan to achieve FSMA compliance.

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Food Safety System (Hazzard Analysis and Risk-based Preventive Controls (HARPC))

CPC's food safety experts know that the key to comply with FSMA regulations, especially in Hazard Analysis and Risk-based Preventive Controls (HARPC) for Human Food (21CFR117)  and Aminal Food (21CFR507) and Foreign Supplier Verification Program (FSVP) (21CFR1 Subpart L) is to develop and implement an effective and comprehensive Food Safety System, which includes:

  • Good Manufacturing Practice System (Prerequisite program for food safety)

  • Hazard Analysis and Preventive Controls Determination

    • Hazard Analysis

    • Process Preventive Controls

    • Food Allergen Preventive Controls

    • Sanitation Preventive Controls

    • Supply-Chain Preventive Controls

  • Recall Plan

  • Reanalysis of Food Safety


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​​Dietary Supplement and FSMA

Due to the complexity of FSMA, some dietary supplement companies have misperception that they are exempt from the FSMA rules since they are already subject to Dietary Supplement cGMP (21CFR111). 

Food Defense Plan (Intentional Adulteration)

Food facilities – either in the U.S. or any other country – that are required to register with FDA as food facilities because they manufacture/process, pack, or hold human food for consumption in the U.S. are subject to Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) (21CFR 121).  The rule requires all covered facilities to develop and implement a written food defense plan unless an exemption applies, which includes:


  • A written food defense plan that includes:

    • A vulnerability assessment to identify significant vulnerabilities and actionable process steps, and associated explanations

    • Mitigation strategies and associated explanations

    • Procedures for food defense monitoring

    • Procedures for food defense corrective actions

    • Procedures for food defense verification

  • Training for certain personnel

  • Record keeping of pertaining procedures and records

  • Reanalysis of food defense plan

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​​Food Sanitary Transportation Plan (ST)

This rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food, which includes requirements for:

  • Vehicles and transportation equipment

  • Transportation operations

  • Record keeping


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Hazard Analysis Critical Control Point (HACCP)

HACCP is a management system addressing food safety through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.  Juice and Seafood are subject to mandatory HACCP requirements while other foods are subject to HARPC.


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