Records, FDA Oversight & Importer ID
Hazards & Hazard Analysis
Exemptions & Modified Requirements
Supplier Evaluation, Verification & CAs
Pot Pourri
100
True or false: FSVP records must be signed
True. You, as a food importer, must sign and date records concerning your FSVP upon (a) initial completion and (b) any modification of the FSVP.
100
Radiological hazards, natural toxins, and allergens are all examples of...
Chemical hazards
100
True or false: If you conduct a hazard analysis for the the food you import and determine that there are no hazards requiring a control, you do not need to approve your supplier nor conduct foreign supplier verification activities
True. [1.504(f)]. However, in conducting a hazard analysis, you may need to consider supplier performance as hazards may be facility specific.
100
Name 3 accepted FSVP verification activities
(1) Onsite audits; (2) Sampling and testing; (3) Review of records You may perform 1 or more verification activities; other verification activities may apply.
100
True or False: Dietary supplements, packaging and other food contact substances fall within the FDA's definition of "Food"
True. But for a million points, do food contact substances include equipment?
200
True or False: FSVP records may be in a language other than English.
True. Records may be maintained in a language other than English, but an English translation must be provided in a reasonable amount of time requested.
200
True or false: Economically motivated hazards must be considered in your hazard analysis.
DAILY DOUBLE: True. Give an example for TWICE the points!
200
If a food has a hazard, but the food would generally not be consumed prior to the hazard being effectively controlled (e.g. coffee beans), you are not required to:
Conduct an evaluation of a foreign supplier performance nor perform supplier verification activities. You still must document that the food falls in this category.
200
What is the required audit frequency for a food for which a SAHCODHA hazard has been identified?
Once prior to importing the food and at least annually thereafter.
200
True or false: FDA does not require documentation of evaluations of suppliers that importers don't approve.
True. But approval of a foreign supplier must be documented.
300
How long are you required to retain FSVP records?
(1) At least 2 year after their use is discontinued (e.g. after discontinuing a particularly supplier or employee); and for all other records (2) at least 2 years after you created or obtained the records.
300
Name 3 categories of biological hazards
Bacteria, viruses, parasites
300
Name 4 exempt product categories
Juice, seafood, food imported for personal consumption, food imported for research or evaluation, alcoholic beverages, raw materials and other ingredients used in the MPPH of alcoholic beverages, USDA inspected foods (dead meat and poultry, processed eggs) Live animals are exempt, but are covered under CVM.
300
True or false: A supplier may conduct their own audit.
False. The supplier may not perform their own audits or records review, but they can conduct their own testing and provide those results (e.g. in a COA).
300
What is a serious hazard?
A hazard that may result in Serious Adverse Health Consequences Or Death in Humans or Animals (SAHCODHA) DOUBLE DOUBLE: If a serious (or SAHCODHA) hazard is identified, what becomes a mandatory verification activity?
400
For each line entry of food product presented for entry into the U.S., the following 3 pieces of information must be provided electronically when filing entry with CBP:
Importer's (1) name, (2) email address and (3) unique facility identifier (UFI) identifying the FSVP importer of food
400
True or false: Undeclared allergens represent more than 1/3 of Reportable Food Registry (RFR) reports?
DAILY DOUBLE True. Can you name all 8 major food allergens?
400
True or False: Food that is imported for personal consumption is subject to the FSVP regulation.
False.
400
True or False: If relying on a supplier audit, the audit must consider all FDA food safety standards food is subject to (e.g. seafood/juice HACCP, LACF regulations, etc)
True. Additionally, the supplier's written food safety plan and implementation records must be reviewed and the audit must be performed by a qualified auditor *Qualified auditor can be a government employee (US or foreign) or a private entity.
400
True or false: verification activities must be performed or overseen by a qualified individual
False. They cannot oversee someone who is not a QI. *QIs must also document verification activities.
500
Who is responsible for initiating a recall of an imported food?
Often the entity that is most recognizable to the public takes responsibility for initiating the recall, but the entity most responsible for the contaminated event may be responsible. Either way, the FSVP importer is responsible.
500
What are general maximum and minimum limits (in millimeters) for a physical object to be considered a food safety hazard?
7 to 25 mm. For more details and exceptions, refer to CPG Sec. 555.425
500
What is a very small importer? (Hint: Applies to importers of animal and human food)
If, during the previous 3-year period, your annual average sales of food plus the U.S. market value of food imported, processed, packed or held without sale is (1) less than $1M U.S. for human food or (2) less than $2.5M for animal food, adjusted for inflation using 2011 as base year. Must also include sales of any subsidiaries or affiliates.
500
What 3 things must you consider when evaluating supplier performance and food risk
(1) Hazard analysis and nature of hazard requiring a control; (2) Who is controlling the hazard; (3) Foreign supplier performance (e.g. food safety practices, history, non-compliances, warning letters, import alerts)
500
When are reevaluations necessary?
(1) Any time you become aware of new info that may affect your food and foreign supplier performance evals (2) Generally every 3 years *No reevaluation req per se for importers under modified requirements. Must still take prompt, appropriate CAs, if aware of potential food safety issue. Should monitor whether modified reqs still apply.
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