We offer many tools and services to help companies comply with the many FDA food safety requirements. We help food importers with FSVP plans and assist manufacturers with Food Safety Plans, HACCP, Food Defense, and recalls. FSVP Plan The FSVP is a foreign supplier verification program. Under FSVP regulations, the FDA requires that importers verify that their foreign suppliers conform to FDA food safety regulations and FSMA’s Preventive Controls (or that they follow procedures that provide the same level of food safety). Therefore, the most critical components of the FSVP are evaluating your supplier’s food hazard controls, evaluating their overall compliance, and incorporating a verification step (such as on-site audits or testing) to determine actual compliance. Food Safety Plan / Preventive Controls A Food Safety Plan identifies hazards (i.e., any agent or condition that can cause adverse health effects) and the processes by which they are controlled. There are three types of hazards: biological, chemical, and physical hazards. Biological hazards refer to microorganisms (e.g., pathogens), and viruses. Chemical hazards are those whose chemical composition causes adverse health effects (e.g., biotoxins, allergens, excessive preservatives, and radiological hazards). Physical hazards are those whose physical shape and structure can cause adverse health effects (e.g., metal fragments).

Preventive Controls are also known by their longer name “Hazard Analysis and Risk-based Preventive Controls.” Preventive controls require a written food safety plan that details the following elements: (1) hazard analysis – identifying hazards (biological, chemical, or physical), (2) preventive controls to manage or eliminate the hazards, (3) a supply-chain program, (4) recall plan, (5) monitoring program, (6) corrective action procedures, and (7) verification procedures. Food Defense

1. Vulnerability assessment – identifying vulnerability of each food type in the facility and include actionable process steps where mitigation strategies can be applied to minimize the risk.
2. Mitigation Strategies – application of current scientific understanding of food defense to create strategies to mitigate identified vulnerabilities.
3. Monitoring – procedures for making sure that the mitigation strategies are being implemented.
4. Corrective Action – procedures for corrective actions that are necessary when mitigation strategies are not being properly implemented.
5. Verification – procedures for conducting verification activities to determine whether monitoring and corrective actions are being done, as well as to verify the effectiveness of mitigation strategies.

Exemption from Food Defense

• Facilities that only hold food, except holding food in liquid storage tanks
• Facilities in charge of packing, re-packing, labeling, or re-labeling food where the container that directly contacts the food remains intact
• Facilities that manufacture, process, pack or hold food for animals
• Farms
• Alcoholic Beverage Manufacturing
• Animal Food Manufacturing
• Very Small Businesses (those businesses, including affiliates and subsidiaries, averaging less than $10 million in sales of human food, plus the market value of human food manufactured, packed or held without sale)

HACCP Plan Hazard Analysis Critical Control Points (“HACCPs”) are used around the world to manage food safety risks. HACCP focuses on identifying biological, chemical, and physical hazards inherent in producing food, identifying critical points in production where these hazards can be controlled, and monitoring and recording implementation of those controls. While HACCP is only required for fish and juice under FDA regulations and meat/poultry under USDA, HACCP principles are used across the food industry. In fact, the same principles are applied in FDA’s Hazard Analysis and Risk-Based Preventive Control.