Starting up as an importer or just not making very many sales? If you meet the definition of a very small importer, you may not need to follow the standard requirements.
What do standard requirements require?
In general, the standard requirements require that you:
Use a Qualified Individual to develop an FSVP
Conduct a hazard analysis
Evaluate and approve your suppliers
Determine an appropriate supplier verification activity (and frequency)
Maintain your records for 2 years
As a very small importer, you would need to perform the following activities:
Use a Qualified Individual to develop an FSVP
Substantiate, with financial records, that you meet the definition of a very small importer
Choose to comply with the applicable sections of the FSVP regulations
Collect and maintain the records that support your determination and provide assurance that the definitions and conditions are met
Document corrective actions
Doesn’t that mean that food imported by very small importers is less safe?
FDA still requires very small importers to import food that is free of adulteration and misbranding, and that meets the same level of public health protection (SLPHP) as required by the Food, Drug & Cosmetic (FD&C) Act (and its implementing regulations). So while the expectation for very small and very large importers are the same, the tools for enforcement vary. underlying assumption is that importing less food poses less of a risk to public health (see commment 67 of the Final FSVP rule).
How are modified requirements different for very small importers?
Unlike other entities subject to other modified requirements, “Very small importers” are not required to compose evaluations and reevaluations, document approval of suppliers, and establish written procedures for ensuring that food is imported only from evaluated and approved suppliers.
Very small importers must obtain written assurance from their suppliers that they are in compliance with applicable food safety laws and regulations. The regulation states:
“If you are a very small importer, for each food you import, you must obtain written assurance, before importing the food and at least every 2 years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection (SLPHP)* as those required under section 418 or 419 of the Federal Food, Drug, and Cosmetic Act (FD&C) if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C.” Source: 21 CFR 1.512(b)(3)(i) *Acronyms added
But are you and your supplier confident that you are in compliance with the following?
FD&C sections 418 or 419, and their implementing regulations
FD&C sections 402 or 403(w)
SLPHP determination process
Most people have not (and will not) read these laws. Most people don’t even know how to find them (FYI - Links located at the bottom of this post). Maybe you feel that you and your supplier are doing everything you can to ensure safe food, so your plan is to cross your fingers and hope that is enough. The reality is that most suppliers will simply provide a written assurance (QA’s version of a “pinky swear”) to provide you with safe, non-violative food. But what risk are you assuming? We address that below.
So is there anything wrong with just requesting a written assurance from my supplier?
It’s risky. Remember, the written assurance alone will not protect you from regulatory action in the event that adulterated or misbranded product enters the United States, nor would it protect you in a court of law, assuming the violative product were to injury or kill someone.
What should I do next?
By developing and implementing an evaluation process (not required), you will be in a better position to limit your liability and prevent food safety problems from occurring. And by establishing written corrective action procedures (not required), you will be better prepared to document appropriate corrective actions (which are required).
To ensure a structured approach to developing your FSVP, you can use the standard requirements and simply narrow your evaluation process to SLPHP. Both of these approaches are scale-able: when your business grows, new FSVP compliance activities will be less traumatic.
If you’d like to discuss your options or have any questions, please leave a comment. For more information on SLPHP, see FDA’s draft guidance: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507: Guidance for Industry.
Below are links to the related (a) Laws, (b) Implementing Regulations and (c) Homepages, where guidance and other relevant materials may be accessed:
Foreign Supplier Verification Program
Preventive Controls for Human & Animal Food
FDA. “See Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA Regulation: Guidance for Industry Small Entity Compliance Guide”. January 2018.
FDA. “Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507: Guidance for Industry, Draft Guidance”. January 2018.