Frequently Asked Questions (FAQs) | Food Quality & Safety

Does each entry on HACCP-generated records have to be signed and dated?

CFR 417.5(b) states: Each entry on a record maintained under the HACCP plan shall be made at the time the specific event occurs and include the date and time recorded, and shall be signed or initialed by the establishment employee making the entry.

CFR 417.5(c) states that prior to shipping product, the establishment shall review the records associated with the production of that product to ensure that all critical limits were met and, if appropriate, corrective actions were taken, including the proper disposition of product. Where practicable, this review shall be conducted, dated, and signed by an individual who did not produce the record(s).

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What corrective actions meet CFR 417.3 for zero tolerance when fecal contamination is found?

All of the product back to the last acceptable check must be held. According to 417.3(a), the cause of the deviation must be identified and eliminated. The CCP must be under control after the corrective action is taken. Measures must be taken to prevent recurrence and to ensure no product that is injurious to health enters commerce.

This means that all products after the last acceptable fecal check is considered potentially contaminated and the establishment must take actions to assure that the contaminated product does not enter commerce. Such product should be free of visible feces and the cross contamination issue should be addressed.

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If the establishment has slaughter and only simple processing, is it necessary to have more than one plan?

No, it is not necessary. It is acceptable for slaughter and simple processing to be covered with the same plan. It is also considered acceptable for these to be covered by separate plans.

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What is the appropriate appeal process for industry?

If the establishment disagrees with inspection personnel's decisions, the decision can be appealed through the chain of command. That is, Inspector In Charge (IIC), Circuit Supervisor, District Office, and Headquarters.

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Who at our plant is required to receive HACCP training in order to develop our plan and what requirements of the final rule need to be fulfilled?

Only one individual requires HACCP training to develop your plan. As stated in CFR 417.7 the individual must successfully complete a course of instruction in the application of the seven HACCP principles in meat or poultry processing, including a segment on the development of a HACCP plan for a specific product and on record review. An individual that is HACCP trained but not an employee of your establishment can also help create your plan.

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Can pre-shipment review be performed on a continuous basis?

Pre-shipment review can be performed on a continuous basis as long as the regulatory requirements are met for the pre-shipment review. CFR 417.5(c) states that prior to shipping product, the establishment shall review the records associated with the production of that product to ensure completeness, including the determination that all critical limits are met and, if appropriate, corrective actions are taken, including the proper disposition of product.

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Can FSIS inspection personnel require CCPs even when the establishment has performed a hazard analysis and it reveals no food safety hazard that is reasonably likely to occur?

FSIS inspection personnel are not to require CCPs. CCPs are to be determined by the hazard analysis. As noted in the Pathogen Reduction and HACCP rule CFR 417.2 a food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred; or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls. Questions about whether or not a CCP is needed should be addressed to the District Office.

When is Nutrition labeling required?

The Nutrition Labeling and Education Act of 1990 (NLEA) became law on November 8, 1990 and has led to significant changes in food labeling regulations. These regulations address three primary areas: the nutrition label, nutrient content claims, and health claims.

The new nutrition labeling regulations in 21 CFR 101.9 require nutrition labels on almost all packaged foods, revise the list of nutrients whose content levels are required to be shown on the nutrition label, adopt a new format for the nutrition label, and provide for more consistent serving sizes across product lines to reflect the amounts people actually eat. The basic nutrition label is to list 14 nutrients. The nutrients and the order in which they must be listed are: calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron. Other vitamins and minerals for which Reference Daily Intakes (RDI's) have been established must be declared if a claim is made about them or if they have been added as a nutrient supplement.

In addition to these mandatory nutrients, manufacturers may voluntarily choose to include calories from saturated fat, and amounts of polyunsaturated fat, monounsaturated fat, potassium, soluble fiber, insoluble fiber, sugar alcohol, other carbohydrates, other vitamins and minerals for which RDIs have been established, and beta-carotene (as a percent of vitamin A). The amounts of nutrients declared in nutrition labels are for the product in the package, before consumer preparation. However, when foods are not intended to be consumed as packaged, manufacturers are encouraged to add another column of information specifying the percent Daily Value of a serving of the food "as consumed."

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What are FDA requirements regarding Nutrient Content Claims?

Nutrient content claims are those claims that describe the amount of a nutrient in the food (such as "sodium free" or "low fat"). These claims may not be made unless they are defined by FDA in regulations. General provisions for the use of nutrient content claims have been established in 21 CFR 101.13. Specific regulations have been issued that define the use of the terms "good source," "high," and "more" (21 CFR 101.54) and the terms "light" or "lite" (21 CFR 101.56). Separate regulations also cover the use of nutrient content claims for caloric content (21 CFR 101.60); sodium content (21 CFR 101.61); and fat, fatty acid, and cholesterol content (21 CFR 101.62). Various synonyms have also been established for the basic terms. Persons considering using nutrient content claims on the label or labeling of their products should refer to the above regulations for details on the requirements.

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What are FDA requirements for Food Additives?

"Food additives" are substances which may by their intended uses become components of food, either directly or indirectly, or which may otherwise affect the characteristics of the food. The term specifically includes any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding the food, and any source of radiation intended for any such use under Sec. 201(s).

But the law excludes from the definition of a "food additive":

1. Substances generally recognized as safe by qualified experts.
2. Substances used in accordance with a previous approval ("prior sanction") under either the Federal Food, Drug, and Cosmetic Act, the Poultry Products Inspection Act (21 U.S.C. 451) or the Federal Meat Inspection Act (21 U.S.C. 601).
3. Pesticide chemicals in or on raw agricultural products.
4. Color additives.
5. New animal drugs.

(Note: pesticide chemicals, color additives, and new animal drugs are subject to similar safety requirements of other sections of the law).

Manufacturers or importers not certain whether the chemicals or other ingredients used in their foods are subject to the safety clearance requirements of the Federal Food Drug Cosmetic Act (FFDCA) may seek an opinion from the Food and Drug Administration. If premarket approval is required, this may mean that studies, including animal feeding tests, will have to be carried out in accordance with recognized scientific procedures, and the results submitted to the Food and Drug Administration for evaluation. General principles for evaluating the safety of food additives are published in 21 CFR 170.20. General instructions for preparing a food additive petition are in 21 CFR 171.

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