Food Safety Assessments / noie / nr / fsa / appeals

The U.S. Congress has recognized that foodborne illnesses are a significant public health concern and impose major economic threats to the food production industry. They have concluded that the illnesses can be prevented and have codified the FDA Food Safety Modernization Act (FSMA), legislation designed to amend the Food, Drug, and Cosmetic Act of January 2011. The FSMA will directly address food-borne illness preventative measures.  To help keep pace with the constant changes in the global food system, the FSMA will be a transformational rule, shifting the focus of current food safety practices away from traditional responsive reactions, and toward proactive illness prevention. The FSMA is enacted and enforceable.

How will the FSMA impact your business as a producer, or processor? Will you have to worry about heavy handed regulators coming into your facility and demanding records? How will you demonstrate that you are producing a safe product? How do you mitigate your liability risk? How can you assure standardized production practices for quality control? These are all valid, and relevant questions. Navigating the complicated gauntlet of regulations can be confusing, and overwhelming.  Even with an established operation the industry, and federal agency changes are constant and ever-evolving.   Being proactive and operating from a position of confidence will allow for easy alignment with, and adjustment to, regulatory changes. Our philosophy is to work with your business to design and implement an individualized food safety system that will be proactive in nature rather than reactive. Our knowledge of the food production, and the food safety, industries will benefit your compliance program and will put your company in a strategically advantageous position when dealing with state, and federal regulators. This is accomplished through critical safety processes that will be developed, and tailored to, your specific operational needs.

Good Manufacturing Practices are general, basic, standard, practices that you may already have, in some form. However, Current Good Manufacturing Practices (cGMP’s) are required to ensure that your facility, and your manufacturing processes are current, and continually updated to match regulatory changes.  cGMP’s are designed to be routinely updated to adequately represent the processes, product flow, and the operational layout of your facility. These include critical control points, and hazard analysis components, that demonstrate consistently safe production. It sounds like a fairly simple process, however, keeping the program up and running within regulatory guidelines can be challenging. Remember, the “C” in cGMP’s is for “current”, meaning the cGMP’s themselves are a living, evolving, document and must be updated periodically, or you may face a regulatory control action. The FDA will require producers and processors to implement cGMP’s into their food safety systems.

Additionally, the Food Safety Modernization Act (FSMA), will include the requirement for Hazard Analysis and Risk-Based Preventive Controls (HARPC). The FDA originally promulgated the HARPC regulation for the food industry in September 2015. HARPC requires almost all food manufacturers, processers, packers, and storage facilities, to prepare, or have prepared for them, a food safety plan. This includes:

  > A hazard analysis to identify specific hazards in the process

  > Implement controls to minimize and/or eliminate food safety hazards.

  > Verification activities to demonstrate the controls are working.

  > Construct and employ, corrective actions to address any deviations from the controls that

     may occur during the production of the product.

  > Supply chain management controls must be implemented to address risks associated with

     raw materials or other ingredients or processing aids.

  > A recall plan must also be designed and periodically tested to determine effectiveness.

Everything in a HARPC plan must be properly documented and must conform to FDA’s standards and definitions for surrounding facilities, controls, hazards, and the adulteration of foods. HARPC requires each facility to document all aspects of its plan, periodically review it, constantly maintain it, and document all verification steps and protocols.

There are certain exemptions provided for in the law. However, except for very small businesses, most consumable products will originate in, or process through, facilities that are subject to HARPC regulations. For all consumable products supply chains, domestic or imported, HARPC represents a substantial new regulatory requirement with an unprecedented level of coverage for the industry that must be taken seriously. Companies must create their unique food safety plan compliant with HARPC, update it, and produce the documentation to FDA upon request or inspection. The implementation of a HARPC program must also incorporate regulatory cGMP’s. This project can be onerous, and time consuming and that’s where we come in – we have the expertise, computer software, and established reputation to make this happen for your business.

Government regulation, and compliance certification, are necessary components of safe production practices, and successful marketing to the consumer. We are here to help you through every phase of the process. We can provide access to a customized software program to manage your inventory, production protocols, and regulatory compliance. We are available for on-going consulting services to help with future issues. And, in the unfortunate event that you someday face a regulatory action by a governing agency, we have the expertise, reputation, and established industry contacts, to help make any necessary adjustments to your processes and guide your responses to the regulators.