What is the FSMA?
FSMA stands for the Food Safety Modernization Act. It was signed into law on January 4, 2011. The main goal of FSMA is to give FDA tools to make sure that imported foods meet the same safety standards as domestically produced food in the United States.
What is FSVP?
“A program that importers covered by the rule must have in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.”
In other words, FSVP is a program under FSMA that food importers must have in place to make sure the food they import is safe and not adulterated!
Who must comply?
FDA has created a yes-no flow chart that helps importers determine if they are required to comply: https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM472461.pdf
There are some food products that are exempted from the FSVP requirement. They include the following:
• Juice, fish, and fishery products subject to FDA’s Hazard Analysis and HACCP regulations.
• Certain meat, poultry and egg products already regulated by USDA
• Alcoholic beverages– regulated by ATF
• Food for personal consumption
• Food for research
• Low-acid canned foods (LACF)
Note that even importers of food contact substances are subject to the FSVP requirements. A food contact substance is any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if the substance is not intended to have any technical effect on the food.
Note that the FSVP definition of importer slightly differs from the Customs definition of importer. For FSVP, the importer is the owner of the food at the time of import to the United States.
How to comply and create a valid FSVP?
Create written procedures to ensure that food is only imported from foreign suppliers approved based on an evaluation of risk. Note that a separate evaluation must be performed for EACH different food product and supplier combination.
Step 1.) Perform a hazard analysis of the supply chain
—->This analysis should cover:
—-> —->Biological hazards (parasites, bacteria, etc.)
—-> —->Chemical hazards (radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved food or color additives, food allergens, etc.)
—-> —->Physical hazards (glass, etc.)
—->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.
—->Evaluation must consider the following factors:
—-> —->Formulation of the food
—-> —->Location where food is being processed.
—-> —->Equipment used to process 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
—->List out foreseeable hazards related to a specific site (including actual foreign supplier’s manufacturing site).
—->If another entity has analyzed known or reasonably foreseeable hazards, you may meet the requirement by reviewing and assessing the hazard analysis performed by another entity. This document must be reviewed by a qualified individual.
Step 2.) Perform an evaluation of foreign suppliers
—->This must occur BEFORE importing food
—->Evaluations of foreign supplier’s performance and the risk posed by a food must consider:
—-> —->The hazard analysis and nature of hazard requiring control.
—-> —->Who is controlling the hazard
—-> —->Foreign supplier performance, including:
—-> —-> —->The foreign supplier’s food safety practices
—-> —-> —->The foreign supplier’s food safety history
—-> —-> —->Procedures, processes, and practices related to food safety
—->The analysis must be conducted by a qualified individual.
—->The analysis and review must be documented.
Step 3.) Verify that foreign suppliers are meeting the requirements of their evaluation.
—->There are three possible verification methods:
—-> —->Onsite auditing
—-> —->Sampling and testing
—-> —->Review of supplier records
—->Verification may be performed by 3rd party entity, but cannot be completed by the actual foreign supplier.
Step 4.) Implement corrective actions (if needed)
—->Examples of corrective actions:
—-> —->Instructions on how to fix the problem along with timeframe for fixing the problem.
—-> —->Discontinuing the use of a specific supplier
—->Must be documented
Step 5.) Reevaluate foreign supplier – every three years OR sooner if the importer discovers a food safety issue OR if the importer is aware of a new development in the foreign supplier’s food safety program.
• At the time of import, a FSVP importer must be named. Specifically the three following pieces of information must be submitted to FDA.
o Name of FSVP importer
o Email address
o Unique Facility Identifier (UFI) identifying the FSVP importer
At this time, the only acceptable UFI number is the DUNS number.
Modified Rule For Very Small Businesses
• FDA has also created a modified rule for “Very Small Businesses”. Importers who qualify as a “Very Small Business” would be subject to the modified requirement of obtaining a written assurance of compliance from their suppliers. Very small business means, for purposes of this part, a business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee).)
Deadline for compliance: Timeline
• Small Business (Small business means, for purposes of this part, a business (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees.) – March 19, 2018
• Very Small Business – March 18, 2019
• Suppliers subject to the pasteurized milk ordinance: March18, 2019
• All other food importers: May 30, 2017
• Importers of Food Contact Substances – The earliest compliance date is May 28, 2019.
Resources and Education
• FSMA training information on FDA website: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm461513.htm
• Food Safety Preventive Controls Alliance (FSPCA) – FDA, in cooperation with the Illinois Institute of Technology’s Institute for Food Safety and Health, created the FSPCA to provide training courses and technical information. They offer a course specifically on how to set up at FSVP.
• FDA “At a Glance” publication on FSVP: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361902.htm