Expert Guidance for Preventing Foodborne Illnesses

Several agencies can have oversight for food manufactured, held, and imported into the United States:

• FDA (Food & Drug Administration) 
  • Registrations, licenses, inspections, labeling, importing
  • Seafood HACCP
  • Juice HACCP
  • Retail or Central Kitchen HACCP (regulated by state or local health departments under the FDA Food Code)
  • Low Acid or Acidified HACCP
  • FSMA – food safety plan
  • Food Warehouses & Distributors
  • Must be registered with FDA for the Bioterrorism Act (FSMA has updated and expanded these requirements through the Food Facility Registration rule)
  • FSVP - importing requirements
  • State Health Departments will also perform random inspections (FDA Food Code)

• USDA (U.S. Department of Agriculture) 
  • On-site inspection required during manufacturing, label approvals, agriculture grading
  • HACCP – meat, poultry, egg
  • USDA warehouses
  • On-site inspector when site produces USDA products
  • Exempt from FSVP (when products are under USDA's continuous inspection; imported USDA-regulated products still follow separate USDA import procedures)

• State Health Departments 
  • On-site inspections, licensing for each state

• State Department of Agriculture 
  • On-site inspections, licensing, routine dairy inspections

Inspection can be Announced or Unannounced.

• USDA – always on site for production (continuous on-site inspection applies only to USDA-regulated products such as meat, poultry, and certain egg products, not all foods)
• Dept. of Agriculture – on-site grading, routine dairy inspection
• FDA – 
  • Routine based on risk of food (ready-to-eat salads. juice, etc.)
  • For Cause – customer illness, recall, etc.
  • Import Alert – product held upon importing
  • Random inspection for compliance with Food Defense or Food Safety Modernization Act (typically risk-based and planned under FSMA rather than truly random, though they can occur without prior notice)
• Health Department – State licensing such as for a Processed Food Registration in CA

• USDA 
  • Must be closed out with inspector
  • Recall for producing without inspection (typically classified as Class I recalls when there is a health risk and are coordinated with the USDA FSIS Recall Management Division)
  • Non-conformances written on site

• FDA 
  • During manufacturing or warehouse inspection - Form 483 Observations
  • During inspection or at import site (docks) – Form 483 Observations
  • Must respond within 15 days in writing
  • Can lead to product seizure, fines, recalls, increased inspection

Required for importing food into the USA (FDA only). 

• Typically the importer or broker is named as the FSVP importer
• The office must be located in the USA
• They must have an FSVP plan in place PRIOR to bringing food into the USA
• A qualified individual (someone who has taken the FSVP course) must develop the plan
• It is similar to conducting a hazard analysis (risk assessment) of ingredients or finished products
• FSVP importer is the one who will get inspected by the FDA
• Site will be issued a 483 if observations need corrective action
• Requires annual reviews or as needed for any corrective actions, such as import alerts (annual reviews are only necessary when there are changes, issues, or corrective actions, though some companies perform them annually as a best practice)
• There are some modified plans allowed such as for very small importers

While both a Food Safety Plan (FSP) and a HACCP plan (pronounced "hassup") share similarities, they are distinct in their approach to ensuring food safety within food and beverage companies. Understanding these differences is crucial for compliance and maintaining robust food safety practices. 

• Several distinctions exist between a HACCP plan and an FSP. For instance, an FSP addresses chemical hazards, including radiological and economic threats, mandates a Recall Plan, and extends its application to controls beyond Critical Control Points (CCPs). It's imperative to delve into these variances to grasp the nuances of each system.
• Hazard Analysis and Critical Control Points (HACCP) is a preventive management system utilized to identify and evaluate risks and hazards associated with specific foods or production processes. It aims to control identified threats "reasonably likely to occur," as outlined by the Food and Drug Administration (FDA).
• On the other hand, a Food Safety Plan encompasses the primary documents within a preventive controls food safety system, offering a systematic approach to identifying and mitigating food safety hazards. It encompasses written protocols ensuring food safety throughout various stages such as manufacturing, processing, packing, and holding.
• Both HACCP and FSP bear the responsibility of ensuring food safety and quality by establishing and maintaining proactive and effective food safety management systems at the manufacturing level.
• U.S. Federal regulations, enforced by the FDA, mandate HACCP systems for seafood and juice. USDA FSIS mandates HACCP for meat, poultry, and certain egg products. While some organizations necessitate separate HACCP plans for each food product, processing method, and facility due to unique risks involved. Separate HACCP plans for each product, process, or facility are not federally required but are considered an industry best practice rather than a legal mandate.
• Moreover, sectors other than those exempted such as alcoholic beverages and dietary supplements, mandated by regulatory agencies to comply with Preventive Control for Human Food regulations, must develop and implement an FSP.
• Understanding the disparities between these management systems is crucial for ensuring compliance with industry regulations and food safety standards. Delving into each element elucidates how to effectively manage plans tailored to specific industry requirements.

A certifying body is an independent organization that has been accredited for a sector and can provide compliance certificates.

• Their role is to assess the systems for compliance vs. a standard via a third-party audit
• These are separate from Regulatory Requirements and an audit may not cover all areas of FDA or USDA requirements
• They do not interact with Regulatory Agencies except for importing 
  • Third-party audits can be used for verifying supplier compliance of imports
  • Certification bodies are accredited by organizations like the ANSI National Accreditation Board (ANAB) or the United Kingdom Accreditation Service (UKAS), not generally recognized by the Food and Drug Administration (FDA), except in limited cases under the FDA’s Accredited Third-Party Certification Program for imports.
• A facility with a passing third-party audit may not be compliant with regulatory requirements

Most popular are listed below – They cover food, packaging, and warehouse/distribution activities.

• BRCGS – Brand Reputation through Compliance Global Standard, formerly called BRC (British Retail Consortium)
• SQF – Safe Quality Food
• GLOBALG.A.P. (Good Agricultural Practices)
• IFS – International Featured Standards
• FSSC 22000 – Food Safety Certification Scheme
• Primus GFS Standard – Produce (farms & pack houses)
• More certified program owners can be found on the GFSI website

GFSI is a Coalition of Action from The Consumer Goods Forum (CGF), bringing together 44 retailers and manufacturers from across the CGF membership and an extended food safety community.

• Benchmarks and recognizes certification program owners against its requirements for businesses and help provide access to safe food for people everywhere
• GFSI goal is to strengthen and harmonize food safety systems around the world

GFSI does not provide food safety certification.

• They recognize a number of certification programs that meet the GFSI Benchmarking Requirements
• Certification audits can only be performed by Certification Bodies (CB) such as NSF, Merieux, AIB, Intertek, etc.
• Certification Bodies must be accredited against ISO/IEC 17065 or ISO/IEC 17021
• A GMP (Good Manufacturing Practices) or GDP (Good Distribution Practices) audit is not considered a Certification Audit. They also must be performed by a certification body

A-F

• AIB International – American Institute of Baking is a certification body
• BRCGS – Brand Reputation through Compliance Global Standard is one of the GFSI audits
• CB – Certification Body
• CCP – Critical Control Point used in HACCP or Food Safety Plans to control a hazard
• FDA – Food & Drug Administration: regulatory body
• FSSC 22000 – Food Safety Certification Scheme is one of the GFSI audits
• FSMA – Food Safety Modernization Act: It's a law that was passed in December 2010 and officially signed into law in January 2011 by President Obama. The FSMA aims to protect the public by preventing illness through preventive controls across the food supply chain. This includes U.S. food facilities, as well as food products entering the United States from other countries every year
• FSNS – Food Safety Net Services is a food safety testing laboratory
• FSVP – Foreign Supplier Verification Program requires importers to verify that their foreign suppliers of food for human and animal consumption meet applicable FDA safety standards

G-H

• GDP – Good Distribution Practices is a non-certification audit for distributors/warehouses
• GFSI – Global Food Safety Initiative: is a Coalition of Action from The Consumer Goods Forum (CGF)
• GLOBALG.A.P. (Good Agricultural Practices) – a GFSI audit
• GMP – Good Manufacturing Practices or cGMP: Current Good Manufacturing Practices are a system of principles and procedures that ensure products are consistently produced and controlled to quality standards
• HACCP – Hazard Analysis Critical Control Points: a systematic method for managing food safety that identifies and controls potential problems before they occur. HACCP is used to prevent biological, chemical, and physical hazards from entering into food production processes, from raw material production to consumption
• HARPC - Hazard Analysis and Risk-based Preventive Controls (now called Food Safety Plan under FSMA)

I-U

• IFS – International Featured Standards is one of the GFSI audits
• NSF International (formerly known as the National Sanitation Foundation) – is a certification body
• PC – Preventive Control (food safety plan controls, similar to CCP) is a control that prevents a hazard such as baking.
• SCS Global Services – Scientific Certification Services is a certification body
• SQF – Safe Quality Food is one of the GFSI audits
• SOP – Standard Operating Procedure
• SSOP – Sanitation Standard Operating Procedure
• USDA – United States Department of Agriculture

We offer a third-party gap assessment to help customers identify issues such as improper food handling, inadequate refrigeration, and poor sanitation that can lead to pathogen contamination.

Our food safety plan development and review service also provides a comprehensive framework to prevent foodborne illnesses, covering hazard analysis, critical control points, monitoring, and training.

We also assist with developing or reviewing customers' Foreign Supplier Verification Program (FSVP) plans to ensure imported food products meet U.S. food safety standards. This can help customers avoid problems like illegal imports and undeclared allergens and ingredients.