Eleven Rivers Growers, in collaboration with Agroespa, S.C., introduces a Series of Webinars on FSMA-derived food safety regulations and procedures

At the end of May and during June, MC Miguel Ángel de Los Santos lectured four trainings and a discussion panel with a former FDA agent, on the various FSMA-derived food safety procedures and regulations, and the effects in the short and medium term Mexican Exporting companies will have. These trainings were developed through the Zoom platform.

Overview on the FSVP Regulation and its effect on Mexican Exports | May 30

The FSMA Act in the United States requires North American food importers to comply with regulation 21CFR subpart L, Foreign Supplier Verifications Program (FSVP) of the FSMA. The importer must develop, with the support of a qualified person, a verification program by which they can ensure their foreign suppliers are generating food using processes and procedures that provide at least the same level of protection to public health as required under FDA food safety standards for “Risk-based preventive controls (21cfr117) or food safety of fresh produce (Produce rule)”, if applicable.

Exporting companies into the United States, based on this regulation, will be required general to provide general information which proves they are in compliance with the food safety standard being applied to it, and some will be subject to qualified audits, to be developed by US-FDA Authorized Third Party Organizations.

In this training, participants were able to learn about:

  • Overview of the FSMA Act and derived regulations
  • Core requirements of the Foreign Supplier Verification Program (FSVP) regulation
  • The activities of this regulation that will affect food exporters into the United States the most
  • General advice to meet the requirements of your exporter

If you missed this webinar, watch it here:

Development protocols to attend FDA Qualified Audits and Inspections | June 06

In this webinar, MC Miguel Angel de Los Santos shared with participants the legal basis supporting the FDA performance in terms of safety audits of food and inspections. He showed participants the various base documents the agency uses, the criteria for choosing the facilities to be inspected, the requirements and tools to carry out the audit, and the recommendations on how to proceed with these requests.

Participants were able to learn about:

  • General context of the audits and facility inspection
  • The FDA Foreign facility inspection process
  • Scope and general process of preventive and regulatory food safety audits and by whom
  • General recommendations for addressing regulatory audits and FDA inspection

If you missed this webinar, watch it here:

The FDA Import Alert Business Release Process | June 13

What is an Import Alert (DWPE)? It is an administrative action (block) applied by the FDA whereby you inform FDA field personnel and the general public that the agency has sufficient evidence to allow detection without a physical examination (DWPE) to products that appear to be in violation of FDA laws and regulations.

Detection without physical examination (DWPE) of a product, company, exporter, etc. You may apply to be in the detection without physical examination list when there is information indicating that produce may not be food safe, were not handled in a healthy manner, and/or are not compliant with the laws of the country of origin or the United States.

In this training, participants were able to learn about:

  • Import Alert Information (DWPE)
  • Legal grounds that support the Import Alert
  • The types of Alerts associated with food safety
  • What does the red list, the yellow list and the green list mean?
  • How is an import alert communicated?
  • The general Import Alert business release process

If you missed this webinar, watch it here:

Overview of the Regulation of Health Transportation of Food for Human and Animal Consumption |June 19

In 2016, the FDA issued regulations applicable to Shippers, Loaders, Receivers, and Transporters involved in the Transportation of Food by motor or rail vehicles in the United States. The final FDA rule on Health Transportation of Human and Animal Foods (the Health Transport Rule or ST Standard) and the other rules set out under the Food Safety Modernization Act of 2011 are focused on preventing Food Safety problems through Food supply.

In this training, participants were able to learn about:

  • The scope of the regulation. Who is obliged to comply with it?
  • Microbial and chemical pollutants associated with the transport of food for human consumption
  • General requirements of the regulation

If you missed this webinar, watch it here:

Expert Panel: Changes in the Food Export Process under the FSMA context | June 20

Presented by: MC Miguel Ángel de Los Santos – Advisor Specialized in Regulatory Food Safety Affairs of F, D&C Acts and FSMA Act in the United States and Biologist Luis Charles Chavarría – Former Associate Director of US FDA Latin America at the US Embassy in Mexico City.

Upon the publication of the Food Safety Modernization Act (FSMA) in the United States, we have witnessed that the United States FDA has reinforced its controls and supporting instruments to promptly identify the facilities which may be in violation to the laws managed by the agency as well as polluted food that has a reasonable likelihood of causing epidemic outbreaks that affect human health.

For these reasons, Eleven Rivers Growers in cooperation with Agroespa S.C. have developed this discussion panel, in which we will review the most significant changes the FSMA act has incorporated to food safety controls in the United States, and how those changes are having an impact on the food industry as well as on the export process into that country, taking advantage of MC Miguel Ángel de Los Santos and Biologist Luis Charles Chavarría’s expertise.

In this training, participants were able to learn about:

– Through a discussion panel, a former FDA official and an Expert Advisor on FSMA regulatory affairs, will discuss the main changes and regulatory procedures that have been generated or amended with the FSMA Act, which will have an effect on food exports into the United States.

If you missed this webinar, watch it here:

MC Miguel Ángel de Los Santos is a technical advisor of AGROESPA S.C. Company based in Querétaro, Mexico. He specializes in regulatory food safety affairs derived from the FSMA Act and the United States Food, Drug, and Cosmetic Act.

In 1989, he graduated as an Agricultural Engineer with a Specialty in Plant Production by Universidad Autónoma Chapingo. In 2002, he obtained a Master’s Degree in Quality Management Systems and Business Competitivity at Centro de Investigación y Desarrollo in Michoacán. He has completed various certifications that have trained him in specialized areas of food safety such as Administrative law with an emphasis on health and food safety (UNAM, 2009), Health Microbiology of Food, (UA Querétaro, 2004), General Foundations of Food Safety (UNAM, 2010), HACCP courses, as well as being trained directly by FDA officers in “Inspection processes of foreign facilities”, “Import alerts”, Risk Assessment Methods (MSU, 2012).

He has training certificates issued by the Food Safety Preventive Control Alliance (FSPCA) which enables him to perform as a Train of Trainer in the “Preventive Controls for Human Food” regulations (5b7d0eef Certificate) https://www.ifsh.iit.edu/fspca/fspca-trainers-trainers-human-food and in the “Foreign Supplier Verification Program” regulation (FSVP) https://www.ifsh.iit.edu/fspca/fspca-trainers-trainers-foreign-supplier-verification-programs-fsvp which enables him to teach courses authorized by the alliance to train instructors.

Additionally, he has training certificates from the same alliance which enable him as a Lead Instructor in FSVP regulations (d81ec919 Certificate) and Preventive controls for Human Food (71347ba2 Certificate), which enables him to teach official courses to train Preventive Controls Qualified Individuals (PCQI) and qualified people responsible for importers facilities. https://fspca.force.com/FSPCA/s/lead-instructors?language=en_US. Since 2016 to date, he has lectures over 80 courses in 9 countries.