Summary

Produce food in accordance with sections 402 (with respect to adulteration) and 403(w) (with respect to the labeling of human foods for the presence of important food allergens) of the FD&C Act.

The FDA will hold the FSVP importer responsible for complying with all requirements of the FSVP rule.

If an importer fails to develop an FSVP, has an incomplete FSVP, or fails to reevaluate its suppliers as needed, the FDA may take enforcement action. According to § 1.514, the products will not be admitted to the USA and in case of being in the USA their commercialization is prohibited.

If you are an importer in the USA of food products.

We have a team of professionals ready to offer solutions to the complex regulation and standards that the new Food Safety Modernization Act (FSMA) bring.

Along with instructors, lawyers, and auditors, we will help you, your company, and your suppliers from South and Central America fulfill all the requirements.

We train your staff, carry out the programs required by FSMA, or carry out a Verification Program for Foreign Suppliers.

We solve all your problems so that you import food products to the USA, complying with FDA regulations.

That is from the very beginning all the way to the end.

If you are a food exporter to the USA.

We solve your food export problems and compliance with FDA regulations.

Including an audit of the FSVP Compliance Diagnosis.

We are ready to assist you so don’t hesitate and contact us at once.

With over 30 years of experience in the food business our professionals the on-hand knowledge on how to deal with this new demanding regulation. We have offices in the USA and South America.

The FDA Food Safety Modernization Act of 2011 mandates the creation of a food safety system in which the focus is on preventing contamination rather than primarily reacting to problems after they occur.

 The FSMA rules include those that create preventive controls for the production of human and animal foods, and establish science-based standards for produce grown on farms.

The import community will be most impacted by the Foreign Supplier Verification Programs (FSVP) rule, which requires FSVP importers to verify that the food they import meets U.S. safety standards.

The goal is to ensure that each food is produced in a manner that provides the same level of public health protection as the preventive controls and produce safety regulations, if applicable, and the food is not adulterated or misbranded with respect to allergen labeling.

The following is what the law requires and are the services that we will provide:

We have qualified individuals in Hispano America that will provide you with the following services,

• Determining known or reasonably foreseeable hazards with each food • Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance • Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities • Conducting supplier verification activities • Conducting corrective actions, if it is necessary.

We are going to establish and follow written procedures to ensure that you import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance or, when necessary, on a temporary basis, from unapproved suppliers whose foods are subjected to adequate verification activities before being imported.

We are going to identify and evaluate by you—based on experience, illness data, scientific reports, and other information—the known or reasonably foreseeable hazards for each type of food it imports to determine if there are any hazards requiring a control. These include: • Biological hazards, including parasites and disease-causing bacteria • Chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved food or color additives, and food allergens • Physical hazards, such as glass, stones, hard plastic, and metals.

They may be hazards reasonably likely to cause illness or injury that occur naturally, are unintentionally introduced, or are intentionally introduced for purposes of economic gain, such as substituting a less costly ingredient. The analysis must assess the probability that these hazards will occur in the absence of controls and the severity of the illness or injury that could occur. The evaluation would have to consider factors that include the: • Formulation of the food • Condition, function and design of the establishment and equipment of a typical entity that produces the food • Raw materials and other ingredients • Transportation practices • Harvesting, raising, manufacturing, processing, and packing procedures • Packaging and labeling activities • Storage and distribution • Intended or reasonably foreseeable use • Sanitation, including employee hygiene.

And in addition, we will control the Food Defense programs following 21CFR121, the Mitigation Strategies law, to protect food from Intentional contamination.

And if your suppliers need training, we have Approved Instructors to give the official courses requested by the FDA, to create the PCQI for Food for Animals or Humans, to instruct those responsible for Agricultural Production Farms, and the FDQI that they must carry out Food Defense programs.

We can also teach the Better Process Control School courses for canned foods or airtight containers of high or low acidity.

Call us, and we will solve your problems, 20 years of work before the FDA guarantees us.

You take care of your business; we will ensure that the food you import is safe and healthy, complying with the same production standards required of companies based in the USA.

Avoid fines, suspensions, or being discharged as a food importer; a phone call will solve your problems.

This course will provide participants with the knowledge to implement the requirements of the “Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals” regulation of the U.S. Food and Drug Administration (FDA). This regulation is one of a number of regulations and guidance that implement the provisions of the 2011 Food Safety Modernization Act (FSMA), which focuses on safe food practices. This course is designed for:

U.S.‐based importers who meet the definition of “importer” in the FSVP rule, which includes those who own or are the consignee of food at the time of entry, or, if no owner or consignee exists, the U.S. agent or representative of the foreign owner.

Others who have an interest in ensuring that the requirements of the FSVP rule are met, including brokers, exporters, foreign suppliers of food that will be exported to the U.S., persons/business owners who currently buy food from foreign sources, and representatives of foreign governments.

The FSVP curriculum was designed by regulatory, academia, and industry professionals and developed with funding from FDA as part of the FSPCA. In contrast to the Preventive Controls (PC) rules, the FSVP rule does not require you to attend a training program following a “standardized curriculum” recognized by FDA. Attending this course, however, will help you understand the FSVP requirements and how those requirements can be met in your particular circumstance.

These courses are taught by Lead Instructors trained by the FSPCA, who have been instructed on how to teach the FDA-recognized standardized curriculum.