Food Safety Modernization Act (FSMA) and Foreign Supplier Verification Program (FSVP) Background Information
About 48 million people in the United States (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable. FSMA was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. FSVP importers with more than 500 employees started complying in 2016, and FSVP importers with less than 500 employees started complying on May 30, 2017.
FSMA Key Facts
Below are some of the important food safety enhancements included in the legislation.
Source: The U.S. Food and Drug Administration Website: https://www.fda.gov/
Foreign Supplier Verification Program (FSVP)
My company is offering important training!!!
The U.S. Food and Drug Administration (FDA) lists your company as a food importer under the Foreign Supplier Verification Program (FSVP), and as such, I would like to bring to your attention changes to FSVP as a result of the Food Safety Modernization Act (FSMA) approved by the U.S. Congress in 2011.
My name is Quintin Gray, and I’m a Lead Instructor for the Food Safety Preventive Controls Alliance (FSPCA) FSVP Course (certificate #825cde11). As a Lead Instructor, I have been trained in FSVP regulations, and on how your company might fulfill the FSMA requirements that went into effect May 30, 2017. Please find attached a copy of my CV and FSVP certificate.
As an FSVP food importer, FSMA gives FDA authority to:
- Request your company’s import records to determine if they comply with FSMA regulations.
- To fine your company or bring charges against your company if your import records do not comply.
- Conduct an on-site investigation without notice, or demand that your company send import documents to FDA. If your import documents are held off site, your company will have 24 hours to provide the documents to FDA
FDA has reviewed more than 9 million product lines since the May 30, 2017 compliance date and has conducted close to 300 FSVP inspections since October 2017. FDA plans to increase inspections significantly this year and has cited FSVP importers with numerous violations including failure to:
- Have an FSVP plan in place.
- Have a written analysis to identify and evaluate known or reasonable foreseeable hazards.
- Establish written procedures to ensure that foods are imported only from approved foreign suppliers.
- Document the approval of foreign suppliers.
- Document the review and assessment of the evaluation of risk of the food and supplier conducted by another entity i.e. a qualified individual*.
- Enter data correctly.
I would like to meet with you to discuss the training course, how your company might prepare for an FDA audit, and how I could review your company’s records as a qualified individual under the FSVP Program.
I’m available to meet at your earliest convenience. Please find attached more information on the FSMA and the FVSP programs.
President and CEO
*Qualified Individual for FSVP: A person who has the education, training, or experience (or a combination thereof) necessary to perform an activity required under this subpart of the FSVP Final Rule Federal Register/Vol. 80. No. 228, and can read and understand the language of any records that the person must review in performing this activity. A qualified individual may be, but is not required to be, an employee of the importer. A government employee, including a foreign government employee, may be a qualified individual.
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