Food Safety Modernisation Act (FSMA):
Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
As part of the US Food Safety Modernization Act (FSMA), the US Food and Drug Administration (FDA) has issued several rules to further clarify the requirements of the regulations. This is one of these rules, which was developed after extensive consultation with numerous stakeholders.
The rule governing Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals applies to importers, defined for this purpose as the US owner or consignee of a food offered for import into the United States. If there is no such entity, the importer is considered to be the US agency or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent.
The FSMA compliance goal is to ensure that foods from foreign suppliers are as safe as those covered domestically under the Produce and the Preventive Controls rules. Therefore, for each food and each supplier of a food product, should they use several suppliers, the FSVP requires importers to:
All of these must be based on the proper documentation and written plans.
Importers that are also manufacturers/processors may be deemed to be in compliance with most FSVP requirements if:
A hazard is defined as something that is reasonably likely to cause illness or injury. Each food must be assessed for likely and foreseeable hazards including biological (e.g. microbes), chemical (e.g. pesticide residues) and physical dangers (e.g. foreign objects like glass).
Hazards may occur naturally, be unintentionally introduced, or be intentionally introduced for many reasons including economic gain (e.g. substituting a less costly ingredient). The analysis must assess the probability of these hazards occurring in the absence of any controls and the likely severity of any resulting illness or injury.
Importers can rely on qualified agents to conduct the hazard analysis but they must review and retain the relevant documentation.
The evaluation must consider many factors, including:
As already noted above, under FSMA’s Foreign Supplier Verification Program, the importer must evaluate both the food risk and the supplier’s performance. If an entity in the supply chain will be using a process that will reduce a specific risk, the importer must assess that entity’s procedures and practices. The importer is also required to review the supplier’s past performance in terms of both food safety and responsiveness in correcting any problems. And, finally, the imported food must meet the applicable FDA food safety requirements.
Based on the above evaluations, the importer must create and implement written procedures to ensure that it only imports from approved foreign suppliers and it must conduct appropriate supplier verification activities on an on-going basis.
Importers have several options to tailor supplier verification activities to unique food risks and supplier characteristics, including:
It is up to the importer to ensure that immediate and appropriate corrective actions are taken should something go wrong. As well as the risks noted for evaluation above, this also includes mislabelling with regard to allergens and adulteration.
The corrective actions will be dictated by the circumstances but the most common is to stop importing from that supplier until the necessary corrective actions are taken and documented to be effective.
Exemptions and Modified Standards:
Modified standards apply to certain foods imported from a country whose food safety standards have been deemed equivalent to the US.
The exemptions for dietary supplements vary depending on whether the imported food is a finished product or an ingredient/component for further processing. Many dietary supplements are already covered under their own Current Good Manufacturing Practices (CGMP) regulations and so importers who can verify that they are meeting these would not be required to meet FSVP requirements as well. If the imported supplement is not already covered by these regulations, the FSVP requirements would apply but the verification process would focus on meeting the CGMP regulations.
Very small importers (less than $1 million in sales of human food or $2.5 million of animal food) and importers of food from certain small suppliers (see below) must meet modified FSVP requirements. For example, certain importers could verify their foreign suppliers by obtaining written assurances from their supplier instead of conducting their own hazard analysis.
Some of the small foreign suppliers noted above include:
And finally, certain categories of imported food are not covered by FSVP. These include:
For full FSMA compliance, Importers must comply within 18 months after publication of the rule, which was on November 27, 2015.
However, if their supplier is subject to the Preventive Controls or Produce Safety Rules, they are required to comply six months after the foreign supplier is required to meet the relevant regulations.
If an importer is itself a manufacturer or processor subject to the supply-chain program provisions in the preventive controls regulations, the date established in the Preventive Controls Rules apply.
The primary purpose of the American Food Safety Modernization Act (FSMA) is to improve food safety standards by changing both industry’s and government’s approach to food safety from reactive to preventive. This ground breaking piece of food safety legislation is broken down into four main sections:
As part of this comprehensive change, the Food and Drug Administration (FDA) has been releasing rules to specifically address important aspects of food safety. These include the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals,the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, and the FSMA Final Rule for Preventive Controls for Human Food.Other rules include:
The changes are dramatic. For example, the regulations address Preventive Controls. The details of this are outlined in the Preventive Controls Rule but, briefly, companies are now required to:
On their side, staff at the FDA is working to establish science-based standards for testing. One area they are specifically focusing on is safe production and harvesting of produce. The Produce Rule is one part of this ongoing process.
The FDA’s Food Safety Modernization Act also gives the FDA the power to hold companies accountable for these preventive controls, primarily through inspection. This represents a huge change in food safety legislation and so the FDA is changing the way its inspection resources
are allocated, utilizing a proactive, risk-based assessment process. The focus is on innovation with the goal of providing effective and efficient services.
Special attention is given to ensuring that imported foods meet the same food safety standards as domestic foods. The Foreign Supplier Verification Rule details the requirements, but beyond stating that importers are required to carry out supplier verification procedures to ensure the imported food is safe, the legislation also:
Should anything go wrong, the FSMA gives the FDA the right to issue a mandatory recall. Although historically most companies have been very cooperative when asked to implement a voluntary recall, this change is an important step in protecting the public health.
In most cases, the Act gives dates of compliance based on the size of the operation and defines very small and small businesses. Very small businesses are given the longest time to reach compliance, small businesses slightly less time and the rest have the shortest time to comply.
Finally, the legislation also recognizes the need for the FDA to partner with state, local, territorial and tribal authorities to enhance the food safety network. As well, the FDA is mandated to work with all of these authorities to provide food safety training, and it offers grants to help increase the number of labs and certified testing facilities.
Companies are strongly encourage to become “FSMA ready” now to mitigate any risks associated with non-compliance, once the rules are finalized.
A critical step on the road to certification is understanding the need to create a food safety culture within an organization, regardless of its size. Food safety initiatives do not happen by accident and require the intentional commitment of leaders at all levels within an organization, starting with its senior management. Implementing food safety measures into a business requires dedication and commitment to developing a ‘food safety culture,’ where everyone involved not only understands the company's "minimum standards" for benchmarking from a particular scheme, but is committed to continuous improvements for food safety through ongoing training and updates to procedures. An organization’s culture will influence how individual employees think about food safety, which is reflected in their attitudes and willingness to participate in training programs. Now more than ever, a food safety culture should be part of every operation and which may determine the overall success when it comes to certification.
Creating a food safety culture requires that the organization’s leaders develop a systems-based approach to food safety to include management’s commitment and style to leadership, communications, work environment and risk perception. The ability to influence and nurture a food safety culture successfully will be the difference between a training program that is meaningful and one that is not – after all, the most effective training program should not only be able to assist an organization on the road to certification, but, more importantly, in the day-to-day operations of the business.
It is critical that organizations adequately train employees at all levels to ensure the criteria established by the desired standards scheme are followed through according to proper procedure. Training can be conducted in a number of ways:
Core areas to consider when establishing a training program:
Research - There are different types of training material and guidelines for each certification standards scheme, depending on the product or industry sector an organization belongs to along the food chain. Find out which one applies and what type of training is recommended. Will a food safety consultant be required or is an online course acceptable? Research is a critical element for consideration when it comes to training throughout the organization, to ensure proper food safety practices are in place across every location.
Choosing a Leader - Every project needs a leader. Food safety training is no different and should be based on an organization’s structure. Depending on the size of the organization, it may be more cost effective to “train the trainer,” sending a person, such as a manager or director, to take formal training on how to set up and administer a training program to employees. Most courses will provide Trainers with materials and manuals in order to conduct in-house training sessions. This is dependent on the training required for adopting or implementing a food safety standards scheme and may require an individual is is well versed in the standard.
Train Employees - Whether an individual from within the organization is responsible for training or someone from the outside, all employees should receive the same level of training so procedures are consistent throughout the operation. It is also imperative to implement a policy for new hires, who will will require proper training about your companies food safety practices and procedures.
Keep Employees Informed - Inform all employees of food safety guidelines and standard schemes protocol measures. Post safety signs and posters to remind employees of procedures and create consistent documentation for follow up and inspections. Many organizations choose to implement handheld devices with software, offering paperless documents in order to streamline their operations.
Monitor - Standards schemes can be very useful to keep food safety top of mind in day-to-day operations, but it’s only effective when everyone in the organization follows it. Putting food safety training into practice will ensure compliance with a standards scheme while mitigating a business’s risk of liability.
Continuous monitoring of management and employees activities are required to ensure proper procedures follow the guidelines, especially when it come to closing out non-conformances.
Where to Find Training - Food safety courses are available through accredited learning facilities or a business that specializes in food safety training. Courses for a specific food safety scheme are available and can usually be found online or through distribution of course calendars.
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Food recall portals provide centralized resources and information for consumers, governments, and/or industry. They help maximize the efficiency of food recall alerts and execution, and include communication tools that can improve collaboration between parties.
The International Food Safety Authorities Network (INFOSAN) is a joint initiative between WHO and the Food and Agriculture Organization of the United Nations (FAO). This global network includes over 180 Member States.
The European Union (EU) has one of the highest food safety standards in the world – largely due to EU legislation, which ensures that food is safe for consumers. Created in 1979, RASFF enables information to be shared efficiently between its members: EU national food safety authorities, EU Commission, EFSA, ESA, Norway, Liechtenstein, Iceland and Switzerland. It provides a round-the-clock service to ensure that urgent notifications are sent, received and responded to collectively and efficiently.
Republic of Ireland
Business to business food recall portals make it easier for businesses to monitor and execute food recalls. Efficient access to information is critical, allowing businesses to take the necessary steps without having to sort through a number of different sources.
USA Industry: Rapid Recall Exchange
Canadian Industry Product Recall Portal
Australian Industry product recall portal - Recallnet
New Zealand Industry - ProductrecallNZ
South Africa Industry
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