Food Safety Program
THE FSMA (FOOD SAFETY MODERNIZATION ACT) and FSVP (FOOD SUPPLIER VERIFICATION PROGRAM) IS THE LAW.
VIOLATION CAN RESULT IN STOPPING YOUR SHIPMENTS AND MORE.
FDA is stepping up FSVP enforcement with stronger consequences for non-compliance.
FDA issued an import alert listing against two importers whose food appears to have had no previous safety issues. This import alert listing is essentially an import ban where the importers cannot import the food until they implement an appropriate FSVP to FDA’s satisfaction.
WHAT IS FSMA?
The Food Safety Modernization Act (“FSMA”) of 2011 was created to prevent, rather than to
react to foodborne illness.
According to the CDC, annual cases of food poisoning result in:
1) 48 million (1 in 6) Americans getting sick
2) 128,000 are hospitalized
3) 3,000 deaths
FSMA provides tools to PREVENT food safety problems BEFORE they occur, rather than trying to identify and REACT to food safety hazards that have already occurred and addresses the safety of humans (and animal foods) from FARM to FORK. There are also provisions to prevent intentional contamination of food.
FSMA encompasses seven (7) rules, each directed to a different industry. One company may fall under several industries. (For ex: I import Product A, pick them up and deliver to my customer, with my own trucks, process or just pack product at my facility.) These rules affect everything in the supply chain, not only produce.
They are as follows:
- Preventive Controls-Human Food
- Preventive Controls – Animal Food
These two require that facilities that manufacture, process, pack, or hold food
MUST implement preventive risk-based controls to ensure food safety. It applies
to both foreign and domestic manufacturers/processors and others.
- Produce Safety
The primary mechanism for reaching out to and educating farmers
- FSVP - Foreign Supplier Verification Program-see below
- Accreditation of Third Party Auditors
- Sanitary Transportation
Efforts to protect foods from farm to table by keeping them safe from contamination during transportation. The goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food. The 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.
- Food Defense (Intentional Adulteration)-
During a Food Safety audit, the certifier stated that being a CTPAT (Customs Trade Partnership Against Terrorism) member was one piece of evidence to demonstrate that the food supplier was preventing and protecting against any sabotage or international adulteration.
WHAT IS THE FSVP?
The Foreign Supplier Verification Program, or FSVP, which is one part (rule) of FSMA was published on November 27, 2015.This portion of FSMA deals with the requirements surrounding food safety of IMPORTED GOODS intended for human consumption in the US. Historically, the Food & Drug Administration (FDA) has been responsible for certifying imported foods and ensuring their safety through sampling and testing programs, supplier registrations and on-site audits. Now, the burden of assurance is being shifted to the importer.
As an importer, the FDA wants you to make sure that your suppliers’ food safety system meets
the same standards that the FDA requires from domestic food manufacturers.
Under the FSVP, food importers must:
- Anticipate the known and foreseeable hazards that are associated with the food they
- Evaluate the risk of the food and the food safety system that the supplier has in place.
This must be reevaluated every 3 years and when there are any changes with the product
- All the above information is used to approve the foreign supplier if their compliance is
- Corrective actions must be taken if there is any non-compliance to maintain the integrity
of the supply chain.
WHAT DOES THIS MEAN?
Food importers must have a written FSVP program and follow these written procedures for verifying the compliance of the foreign suppliers and correcting any known violations. A separate FSVP must be developed for each food item and each foreign supplier, even if it is the same food from different suppliers. All this must be done by a qualified individual.
WHO IS THE FSVP IMPORTER?
- The FSVP Importer must be someone in the USA, who at the time of entry, either owns
the food, has purchased the food, or has agreed in writing to purchase the food.
- It cannot be the Customs Broker.
- The FSVP Importer can but does NOT have to be the Importer of Record (“IOR”).
- The FSVP Importer can be a U.S. Agent or representative.
WHAT HAPPENS IF I DO NOT HAVE A FSVP PROGRAM IN PLACE?
- If FDA finds any evidence that indicates it appears the importer does not have an
adequate FSVP, FDA can stop the importation of that importer’s shipments, even if the
food is safe and the imported food and the foreign supplier are both in compliance. The
law does not require FDA to prove the importer violates FSVP to stop the importation of
a food. Instead, FDA only has to prove that it appears the importer violates FVSP. This
means that the entry will be rejected.
- Prevent Importer from shipping food to their customer.
- FSVP importer’s food will be placed on an import ALERT.
- Future shipments will be detained without Physical Examination and then refusal of
admission into the USA.
- Defined as a “Prohibited Act”, which means one is committing a criminal act and can be
subject to civil and criminal penalties.
WHERE DO I BEGIN AND HOW DO I KNOW IF IT APPLIES TO ME?
Norman Jaspan Associates, Inc. employs Qualified Individuals (QI) who can:
- Develop a Foreign Supplier Verification Program for your business. We have incorporated the iVerify (Cloud Based Software System into the FSVP Program. See below.
- Review your current program and documentation from both you and your business
- Reassess the effectiveness of your FSVP program by being aware of any new information
about the potential risks associated with the food they import and their suppliers.
- Prepare your company for a food safety audit.
- Be present for food safety audits.
3iVerify - Integrated Food Safety Modules
3iVerify is a comprehensive and integrated Food Safety and Quality Management System with all the modules you need to operate an efficient, compliant food manufacturing, processing or importing business. It provides Supplier & Material Approval, Document Control, Corrective Actions & Management Alert and Reporting.
3iVerify is designed for food manufacturers who need to comply with global food safety standards and laws and also for food importers that need to comply with global food safety standards and national laws like FSMA (Food Safety Modernization Act) and FSVP (Foreign Supplier Verification Program). Some of the benefits of the 3iVerify include the following:
- EASY TO USE & NAVIGATE – Interactive dashboard that allows you to quickly navigate to where you need to go to complete your tasks.
- CENTRALIZED DOCUMENTS - Risk assessments, procedures, records and approvals are in one location. Documents are approved by the right people within your organization and PCQI's oversite. Electronic documents are permission based to those that need access.
- SAVINGS - Save time by not having the back and forth emails that take weeks to get documents that are needed. Save money on a system that is affordable and save storage space in email and in your share drive by using a cloud based system.
- 100% AUDIT-READY – Your compliance can be audited in real time. You are able to respond to inquiries within minutes.
The 3iVerify software is a Centralized Supplier Management Program which means that you can use it for your foreign imports and domestic USA food. The benefits are as follows:
- Comply with Global Food Safety Standards
- Automate supplier, raw material and ingredient approval processes
- Document and manage the food safety management system
- Monitor corrective actions that need to be resolved and documented
- Monitor supply chains for problems
- Customer Comments
- Document and manage the food safety management system
- Material Specification
- Certification Management
- Quality Management
- Customer Comments
HOW DOES 3iVerify WORK?
Foreign Supplier Verification Program (FSVP) compliance is a problem which technology can solve cost effectively.
Implementing FSVP manually is costly, time consuming and risky. US food importers may face financial loss through port detention and rejection, fines and prosecution.
Food importers need an efficient way to record and access supplier food safety information so they demonstrate that their suppliers comply with US food safety laws, namely FSVP.
Primority’s 3iVerify solution has been specifically developed to help provide an easy to use framework that takes care of all the inefficient processes of gathering and approving your suppliers and monitoring their performance.
The purpose of FSVP is to ensure that your suppliers operate to the same food safety laws as US food producers.
STEP 1: VERIFY THAT SUPPLIERS COMPLY WITH US FOOD SAFETY LAWS
This is typically done via an on-site inspection of the foreign supplier or via a supplier approval questionnaire.
NJA through 3iVerify solution provides the supplier approval questionnaires you need to do this in a time efficient and automated fashion, saving money and time. After the supplier completes this, then our “PCQI” reviews the information.
STEP 2: FOOD MATERIAL APPROVALS
FSVP also requires importers to carry out a hazard analysis on all food products imported to the USA.
Importers must evaluate hazards and verify that the necessary controls are in place to prevent them.
These activities can be implemented through a number of methods, e.g. on-site inspections, on line questionnaire, testing and sampling and review of food safety records.
If you import a large number of food materials, then an effective system is critical to remain complaint on an ongoing basis.
STEP 3: SUPPLIER MONITORING
FSVP requires importers to monitor the performance of foreign suppliers.
We want to ensure that the suppliers are not involved in food safety incidents and that they continue to control hazards effectively.
Supplier monitoring means staying up to date with your supplier’s food safety status by regularly checking for FDA warnings or detentions and if the supplier is subject to food safety recalls or food poisoning outbreaks.
3iVerify solutions has built in tools that do the checking for you and alert you to any incidents that your suppliers are involved in.
This helps ensure that you implement a proactive monitoring program that can easily be demonstrated to the FDA. It also helps you operate a more effective business.
STEP 4: CORRECTIVE ACTION MANAGEMENT
FSVP requires importers to keep records of corrections and corrective actions regarding suppliers and the food they supply.
This ensures that the importer is proactively managing any issues that may become hazardous to US Consumers in line with US Food laws.
Things can go wrong in any business. What is important is having a method for dealing with the issue and working things so that they do not happen again.
3iVerify solution has a built in corrective action module to facilitate the logging and action tracking of corrections and corrective actions. This provides an effective way to manage issues, monitor supplier performance and demonstrate FSVP compliance.
DOCUMENT CONTROL AND MANAGEMENT
Document procedures are required by FSVP.
Documents must be maintained under document control and staff must be aware of and use approved and documented procedures.
Document management and control is vital in any business where safety and quality are required. This means that a system must be in place for document control, approval acknowledgement and distribution.
3iVerify solution provides a comprehensive document control system that seamlessly handles document management and control. This enables staff to focus and collaborate on FSVP documented procedures and keep everything up to date, accurate and relevant.
VQIP-(VOLUNTARY QUALIFIED IMPORTER PROGRAM)
In October 2018, the U.S. Food and Drug Administration (FDA) started the Voluntary Qualified Importer Program (VQIP). VQIP is a voluntary fee-based program that provides expedited review and import entry of human and animal foods into the United States for participating importers. Both consumers and importers will benefit from this program.
Participating importers will be able to import their products to the U.S. with greater speed and predictability, avoiding unexpected delays at the point of import entry. Consumers will also benefit from the importer’s robust management of the safety and security of their supply chains.
FDA will use its Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) import screening tool to recognize shipments of food that are part of an approved VQIP application. The screening tool will be programmed to recognize and, in most cases, immediately release the shipment, unless examination and sampling are necessary for the public health reasons listed below.
Limited examination and sampling
FDA will limit examination and/or sampling of VQIP food entries to the following situations: (1) “for cause” situations (i.e., investigation of an outbreak or illness); (2) to obtain statistically necessary risk-based microbiological samples (when building a product risk profile based on non-biased surveillance sampling); and (3) to audit a small percentage of import shipments covered by VQIP to verify that products declared in a VQIP entry are consistent with products covered in the VQIP application.
FDA sampling at preferred location
When FDA needs to examine an entry covered by VQIP, FDA will attempt, to the extent possible, to examine an import entry and collect samples at the VQIP food destination or other location preferred by the VQIP importer. If import entry to the U.S. is denied, FDA will assist in fulfilling an importer’s request to U.S. Customs and Border Protection (CBP) to export the refused products from the port preferred by the importer.
Faster lab results
In the event FDA collects a sample of a VQIP food import entry, FDA’s laboratories will prioritize processing of VQIP samples.
FDA will maintain a VQIP Importers Help Desk connecting importers to FDA staff dedicated to responding to questions and helping to resolve concerns. Contact the help desk at FSMAVQIP@fda.hhs.gov, or 1- 301-796-8745.
- You have a 3-year history of importing food into the United States. Your import history is based on importation of all foods, including food that may not be covered under VQIP.
- You have a Data Universal Numbering System (DUNS) numberExternal Link Disclaimer. Don't have a DUNS number, Contact Dun and Bradstreet (D&B) at 866-705-5711 or via e-mail at email@example.com. All entities doing business with the U.S. government can receive a DUNS number free of charge through D&B using the basic service or pay a nominal fee to expedite service.
- You use paperless filers/brokers who received an acceptable rating during their last FDA Filer Evaluation. The filer/broker is the person responsible for submitting import entry and entry summary data on the food into the Automated Commercial Environment (ACE) and as necessary submitting import documents into the International Trade Auxiliary Communication System (ITACS) or through Customs and Border Protection’s Document Imaging System (DIS).
- None of the foods you import, including ones you do not intend to include in your VQIP application, is subject to an import alert or Class 1 recall at the time you submit your application.
- Neither you nor the non-applicant entities associated with a VQIP food are subject to an ongoing FDA administrative or judicial action (e.g., Import Alert, injunction, and debarment), or have a history of significant non-compliances relating to food safety (e.g., an “Official Action Indicated” (OAI) FDA inspection classification; one or more voluntary Class 1 recalls relating to food safety) with no documentation of appropriate corrective actions. NOTE: “Non-applicant entities” are those entities associated with a VQIP food that conduct activities throughout the supply chain necessary for ensuring that the eligibility requirements of VQIP are met. Non-applicant entities associated with a VQIP food include, but are not limited to, the FSVP or HACCP importer of the food (if other than you), the foreign supplier of the food, and the import entry filer/broker.
- If you are the FSVP or HACCP importer (U.S. owner or consignee at the time of entry into the United States or the U.S. agent or representative of the foreign owner or consignee at the time of entry into the U.S.) for a VQIP food, you are in compliance with the supplier verification and other importer responsibilities under the applicable FSVP, juice HACCP, or seafood HACCP regulations.
- If you are not the FSVP or HACCP importer for a VQIP food, you must identify the FSVP or HACCP importer for the food and ensure that the FSVP or HACCP importer is in compliance with the applicable FSVP or HACCP regulations.
- You have a current facility certification for each foreign supplier of the food you intend to import under the VQIP.
- You develop and implement a VQIP Quality Assurance Program (QAP). Documentation of your QAP must be submitted with your VQIP application.
- Within the past 3 years, you have not been the subject of any U.S. Customs and Border Protection penalties, forfeitures, or sanctions that are related to the safety and security of any FDA-regulated product that you imported or offered for import.
- You must pay the user fee before October 1, the start of VQIP fiscal year, each year that you are approved to participate in the VQIP.
VQIP & CTPAT
FDA encourages you to participate in C-TPAT to ensure the food you import under VQIP also receives entry benefits provided by CBP under CTPAT. If your food defense system includes participation in CBP’s CTPAT (Level 2 or level 3) and you acknowledge your participation in CTPAT in your application, you do not need to provide additional information regarding your transportation food defense procedures.
If you would like additional information about how the program works, the different parties that are required to implement the program as well as the fee structure by the FDA, Accredited party and the Food Safety Consultant, https://www.normanjaspanassociates.com/contact-us/
- Automated Supplier/Material Approvals
- Collaborative Document control
- Collaborative Corrective Actions
- Real time Supplier Monitoring
- In House Data Capture
- Custom Report Generation
- Blockchain Readiness
We are FSVP Certified:
Please contact Ronald Jaspan, President of Norman Jaspan Associates, Inc. at
Foodsafety@njai.us or call us at 516-239- 4611 in order to determine if:
- One is subject to the FSVP laws or exempt?
- Do any of these new FSMA rules, other than FSVP, apply to your company?
- Compliance timelines.
- Fee structure.