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The FSVP is the Next FSMA Compliance DateFSVP FSMA
One of the new rules under the Food Safety Modernization Act (FSMA) is the Foreign Supplier Verification Program (FSVP). For most importers of foods into the USA, the FDA has specified that the date they will begin inspecting importers to ensure they are in compliance with the FSVP will be 30th May, 2017. That effectively makes the FSVP the next big milestone of the total FSMA suite of rules.
Americans consume a large amount of imported food. According to FDA, imported food accounts for about 19 percent of the U.S. food supply, including about 52 percent of the fresh fruits and 22 percent of the fresh vegetables consumed by Americans (2013 statistics USDA, Economic Research Service).
Since the mid 1990’s, food borne illness outbreaks associated with imported foods have been steadily increasing, while at the same time, the outbreaks associated with domestically produced foods have declined albeit with a flattening of that decline since 2009.
With the significant amount of food being imported, and a disproportionate increase in food borne illnesses associated with imported products, the FDA reached the conclusion that some steps needed to be taken with respect to imported foods.
The FSVP rule is about ensuring that imported foods meet the same food safety standards that are required of food produced in the U.S., and in addition that procedures are in place that prevent adulterated foods being imported.
Whereas FDA has always recognized that all parties engaged in the production and handling of food have responsibility for ensuring/maintaining its safety, the FSVP rule now requires that importers covered by the rule must have in place a program to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the rules that US based manufactures are required to meet. Importers also must ensure that the supplier’s food is not adulterated under the FD&C Act, nor misbranded with respect to allergen labeling for human food. Allergen labeling is not required for animal food.
Whether the food is imported for humans or animals, either raw or processed, foreign suppliers likely will need to adhere to the Preventive Controls requirements as defined by the Preventative Controls for Human Food rules. These require that facilities that manufacture, process, pack or hold food must implement preventive risk‐based controls to ensure food safety.
Both foreign and domestic manufacturers/processors, packers, and holders of foods now must analyze whether reasonably foreseeable hazards require a preventive control; and if so, implement preventive controls to control those hazards. The process by which this is done is covered within the Preventative Controls for Human Foods, and the Preventative Controls for Animal Foods rules. While the requirements have similarity to HACCP plans that many suppliers are already using, the significant difference under FSMA is that the hazards need to be determined assuming the absence of controls. In other words, the hazard analysis needs to be done assuming your pre-requisite programs are not operating.
The number one principle of the FSVP rule is that food importers must now share the responsibility for ensuring the safety of imported food. This means that U.S. importers of food must verify that their foreign suppliers are meeting the requirements required of them under FSMA.
The definition of an “Importer” is specific to the FSVP regulation (21 CFR 1.500), and is not necessarily the same as the Importer of Record for Customs requirements. The first phrase of the definition says that the importer is the USA based owner or consignee. This highlights the key difference. For the FSVP, the “importer” must be based in the USA. Note that the terms “U.S. owner or consignee” are also defined in the rule as “the person in the United States who, at the time of entry into the USA, either owns the food, has purchased the food, or has agreed in writing to purchase the food.” The FSVP importer has to be identified on the filing documents at the point of entry of the goods into the USA once the FSVP rule is in effect.
To meet the requirements of the FSVP, the Importer will need to;
- Develop a written hazard analysis for each type of food being imported to determine whether there are any hazards requiring a preventative control. Note that this hazard analysis will need to be documented even if there are no hazards identified. This hazard analysis needs be conducted in the manner defined in the Preventative Controls for Human Foods rules.
- If there are any Preventative Controls required, ensure this is documented and these Controls are put in place.
- Determine the Foreign Supplier’s compliance history with food safety regulations, including those of the country of origin, other countries that the Supplier ships to, and the FDA. The compliance history should include results, corrective actions, and verifications of those.
- Research the food being imported to determine if there are any known or foreseeable risks that have been noted with this or similar foods.
- Assess the capability and any risks of other food safety factors such as storage and transport practices.
- Approve or disapprove the Supplier before the food is imported.
- Establish written Corrective Action procedures should any deviations from the defined procedures and controls are detected, and these procedures need to include the requirement to document the details of any corrective action decisions and activities that are initiated.
- Establish and follow written procedures to ensure that foods are being imported only from Approved Foreign Suppliers.
- Maintain a list of Approved Suppliers.
- Establish and follow written procedures to verify the Approved Foreign Suppliers are complying with the appropriate food safety controls in respect of the imported foods, such as the following examples;
- On site auditing
- Sampling and testing
- Review of records
- Regular research into the supplier’s food safety performance as determined by local authorities or the FDA.
- Document the outcomes of these activities including any decisions made as a result of the verification activities or follow up actions taken.
Verification activities do not have to be conducted by the Importer themselves. These activities can be conducted on behalf of the Importer by a third party. The rules also allow the verification activities to be conducted by Government employees of the source country.
If any of the verification activities indicate that there may have been a situation where food safety was compromised, the Importer is required to ensure that appropriate Corrective Actions have been taken to ensure that;
- The food will not pose a risk to consumers.
- The circumstances that resulted in the deviation have been investigated and changes made to the Food Safety Program to ensure that further deviations do not occur.
- The circumstances and outcomes of the incident are fully documented.
- All decisions made and actions taken are assessed and approved by a qualified individual.
The qualified individual is not required to be an employee of the Importer, but does need to be independent from the Foreign Supplier, and be free of any conflict of interest with regard to the outcome of the evaluations.
The Importer will also need to ensure that the FSVP is reevaluated at least every 3 years, when new information becomes available, or when changes or failures occur that may affect the safety of the imported product. That reevaluation, and the decisions and actions arising from that will also need to be documented.
All documents must be signed and dated by the individual who completes them.
The documents need to be held for at least 2 years, and must be made available to the FDA within 24 hours of their request. Note that the FDA is subject to the freedom of information requirements, and as such documents provided to the FDA could be requested by someone from the general public. Given those circumstances, companies that are required to provide documents to the FDA would be well advised to be explicit about the need to protect any proprietary confidential information.
The records and documents must be legible, and they can be stored in a language other than English, provided that an accurate English translation can be provided to the FDA on request within a reasonable timeframe.
There are exemptions that may apply for various aspects of the FSVP. In general, those businesses that are already required to comply with a previously defined food safety plan are exempt.
Examples of the exemptions that exist are as follows;
- Fish or Fishery products (already covered by mandatory HACCP plan)
- Juice (already covered by mandatory HACCP plan)
- Food for research or evaluation (consumers in U.S. not likely to consume)
- Certain alcoholic beverages
- Certain meat, poultry and egg products (regulated by USDA)
- Food imported for personal consumption (consumers in US not likely to consume)
- Food that is transshipped (consumers in U.S. not likely to consume)
- Food that is imported for processing and subsequent export (consumers in US not likely to consume)
- Low Acid Canned Food (covered under separate requirements)
- Dietary Supplements (required to comply with modified FSVP requirements)
- Very small importer – sales less than $1million p.a. (required to comply with modified FSVP requirements)
- Foods imported from a country with a food safety system that is officially recognized by the FDA as equivalent (currently this is only Canada, NZ and Australia, although it is understood that Mexico is well progressed.)
If you or your business is involved in importing foods into the USA, you should review these steps to ensure that you are ready for the coming compliance date;
- Determine if your business would be deemed the Importer for each of the items that are imported into the USA, item by item.
- Ensure that the defined Importer and each of the Foreign Suppliers they source from have registered with FDA
- Assess the nature of the food safety documentation that is already in place for each of the items imported to enable you to do a gap analysis against what is still needed.
- Work with the Foreign Supplier to close the gaps identified.
- Determine who will be the Qualified Individual that has the qualifications, training, and experience to review and approve the plans and documentation associated with the FSVP.
Bruce is an independent Food Science consultant and advisor, providing advice and hands on support to food businesses in the areas of Product Development, organizational design, quality systems and food safety. During all of 2016, Bruce was the Chief Strategy Officer for Actionable Quality Assurance where he lead the commercialization of software specifically designed for restaurant companies to help make their Quality Assurance and Food Safety processes more efficient and effective.
Prior to joining AQA in February 2016, Bruce was the Chief Research and Development Officer at Pizza Hut. Before joining Yum! Restaurants in 2005, Bruce served in various leadership roles with Master Foods, a division of Mars, in Australia, and also served in R&D and QA management roles at HJ Heinz (Australia).
He is a Certified Food Scientist, a certified HACCP practitioner, and is a Certified Manager of Quality and Organizational Excellence from the American Society for Quality. He has also completed the FSPCA Preventative Controls Qualified Individual training.
Bruce earned his B.Sc. in Pharmacology and Biochemistry from the University of Melbourne, and has a Post Graduate Diploma of Clinical Nutrition from the International Academy of Nutrition, Australia.
He is married and has three children. In his spare time Bruce runs, reads, roasts coffee beans, and travels as much as possible to new places so he can experience new foods and cultures.
(Arthur) Bruce Perkin
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