A

Under FD&C Act section 402, a food is adulterated if, among other cases, it contains a harmful substance, contains filthy or decomposed matter, or was prepared, packed or held under insanitary conditions that may have contaminated it. No one has to get sick: the conditions are enough.

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FD&C Act sec. 402 (21 U.S.C. 342)

Allergen cross-contact

The unintentional incorporation of a food allergen into a food. The cGMPs require cleaning of utensils and equipment to protect against cross-contact, and the food allergen controls in 21 CFR 117 aim to prevent it.

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B

BRCGS Food Safety

BRCGS's food safety certification standard for manufacturers, recognized by GFSI. Manufacturers use it to demonstrate safety, quality and legality to retailers and brands.

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C

Correction

An action to identify and correct a problem that occurred during food production, without the other steps of a corrective action (preventing recurrence, evaluating affected food and keeping it out of commerce).

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21 CFR 117.3 (definiciones / definitions)

F

FD&C Act (Federal Food, Drug, and Cosmetic Act)

The core federal law FDA enforces for food. Among other things it defines a major food allergen (section 201), when a food is adulterated (section 402) and when it is misbranded (section 403); it is codified in title 21 of the US Code.

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FDA (Food and Drug Administration)

The US federal agency responsible, among other things, for protecting public health by ensuring the safety of the nation's food supply. It administers the FD&C Act and the FSMA rules for food facilities.

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FDA Form 483

The document an FDA investigator gives management at the end of an inspection when they observed conditions that, in their judgment, may violate the FD&C Act. It is not a final agency determination; FDA encourages a written response with a corrective action plan.

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FDA: Form 483 Frequently Asked Questions

Food facility registration (FDA)

Every facility that manufactures, processes, packs or holds food for consumption in the US must register with FDA before it starts, unless exempt. Plants in Puerto Rico count as domestic facilities, and registration must be renewed every other year, between October 1 and December 31 of each even-numbered year.

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Food safety plan

The written plan 21 CFR 117 requires of covered facilities, prepared or overseen by a PCQI. It includes the hazard analysis, preventive controls, supply-chain program, recall plan, and the procedures for monitoring, corrective actions and verification.

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21 CFR 117.126 (plan de inocuidad / food safety plan)

Food Traceability List (FTL)

FDA's list of foods that require additional traceability records under FSMA 204, such as soft cheeses, shell eggs, nut butters and certain fresh produce and seafood. It also covers foods that contain a listed food as an ingredient if it stays in the same form (e.g., fresh). By direction of Congress, FDA will not enforce the rule before July 20, 2028; the formal extension of the compliance date is still a proposal.

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Foreign supplier

For FSVP, the establishment that manufactures or processes the food, raises the animal or grows the food exported to the US, with no further processing by another establishment (other than labeling or a similarly minor activity).

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21 CFR 1.500 (definiciones FSVP / FSVP definitions)

FSMA (FDA Food Safety Modernization Act)

Federal law enacted on January 4, 2011 that shifts US food safety from responding to foodborne illness to preventing it. FDA implements it through several final rules, including Preventive Controls for Human Food, FSVP and the Food Traceability Rule (FSMA 204).

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FSVP (Foreign Supplier Verification Program)

A program the importer must develop, maintain and follow for each food it imports, providing assurance that the foreign supplier produces it with the same level of public health protection as the preventive controls or produce safety rules require, and that the food is not adulterated or misbranded as to allergens.

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FSVP importer

The US owner or consignee of a food offered for import into the United States. If there is no US owner or consignee at entry, it is the US agent or representative of the foreign owner, confirmed by a signed statement of consent.

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G

GFSI (Global Food Safety Initiative)

An initiative of the Consumer Goods Forum, bringing together retailers and manufacturers, that does not certify plants itself: it benchmarks and recognizes third-party certification programmes. Recognized programmes include SQF, BRCGS and FSSC 22000, under a "once certified, accepted everywhere" approach.

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H

HACCP (Hazard Analysis and Critical Control Point)

A system for identifying, evaluating and controlling biological, chemical and physical hazards across the chain, based on seven principles: hazard analysis, critical control points, critical limits, monitoring, corrective actions, verification and record-keeping. It is mandatory for juice (21 CFR 120), seafood (21 CFR 123) and meat and poultry under USDA FSIS (9 CFR 417).

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Hazard

Any biological, chemical (including radiological) or physical agent that has the potential to cause illness or injury. The hazard analysis identifies which ones require a preventive control.

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21 CFR 117.3 (definiciones / definitions)

I

Import Alert

A public FDA notice about products and firms that appear to violate the law. It lets FDA detain future shipments without physical examination (DWPE); the importer must show the product does not have the violation to get it released.

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FDA: Import Alerts

K

Key Data Element (KDE)

The information tied to a critical tracking event that must be recorded and, when requested, provided to FDA. The required KDEs vary by event, and FDA can ask for them within 24 hours or another reasonable time it agrees to.

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Known or reasonably foreseeable hazard

A biological, chemical or physical hazard that is known to be, or has the potential to be, associated with the facility or the food. If a knowledgeable person would set controls for it based on the hazard analysis, it becomes a "hazard requiring a preventive control."

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21 CFR 117.3 (definiciones / definitions)

M

Major food allergen

The nine foods defined in the FD&C Act: milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans and sesame, plus ingredients containing protein derived from them. Highly refined oils derived from these foods are excluded.

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FD&C Act sec. 201 (21 U.S.C. 321)

Misbranded food

Under FD&C Act section 403, a food is misbranded if, among other cases, its labeling is false or misleading in any particular or it fails to declare a major food allergen it contains (for example, with the word "Contains" followed by the allergen's food source).

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FD&C Act sec. 403 (21 U.S.C. 343)

Monitoring

Conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended. Under juice and seafood HACCP, monitoring must also produce an accurate record for use in verification.

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N

Non-conformance (non-conformity)

Non-fulfillment of a requirement, as found by an auditor. SQF grades them as minor (an isolated lapse that does not compromise food safety), major (failure of a system element or absence of evidence) or critical (a breakdown of control likely to cause a significant public health risk, or systemic falsification of records).

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SQFI: Glossary (Edition 10)

P

Preventive control

Risk-based procedures, practices and processes that a knowledgeable person would use to significantly minimize or prevent the hazards identified in the hazard analysis. They include controls at critical control points and others, such as process, food allergen, sanitation and supply-chain controls.

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Preventive Controls Qualified Individual (PCQI)

A person who has completed training in risk-based preventive controls at least equivalent to the FDA-recognized standardized curriculum, or who is qualified through job experience. The PCQI must prepare, or oversee preparation of, the food safety plan.

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R

Recall

A firm's removal or correction of a marketed product that FDA considers in violation of the law and against which it could take legal action, such as seizure. It can be on the firm's own initiative, at FDA's request or by FDA order; a market withdrawal for a minor violation is not a recall.

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Recall classes: I, II and III

FDA classifies each recall by risk. Class I: a reasonable probability of serious adverse health consequences or death. Class II: may cause temporary or medically reversible effects, or the probability of serious harm is remote. Class III: not likely to cause adverse health consequences.

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S

Sanitation (sanitize)

To sanitize is to treat already-cleaned surfaces with a process that destroys vegetative cells of pathogens and substantially reduces other undesirable microorganisms, without harming the product. The cGMPs require keeping the plant clean and in repair, and cleaning in a way that prevents allergen cross-contact and contamination.

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SQF (Safe Quality Food)

The food safety and quality certification program of the SQF Institute (SQFI), a division of FMI, recognized by GFSI. A licensed certification body audits the site against the applicable SQF code (for example, Food Manufacturing, Edition 10), and the site designates an SQF Practitioner to maintain the system.

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Supply-chain program

A written program required when a hazard in a raw material or ingredient is controlled before the plant receives it. It includes using approved suppliers, deciding on and documenting supplier verification activities (onsite audits, sampling and testing, records review) and showing the hazard has been minimized or prevented.

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T

Traceability lot

A batch or lot of an FTL food that has been initially packed (raw agricultural commodities), received by the first land-based receiver (food from a fishing vessel) or transformed. Each traceability lot gets its own code.

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21 CFR 1.1310 (definiciones FSMA 204 / FSMA 204 definitions)

Traceability lot code (TLC)

A descriptor, often alphanumeric, that uniquely identifies a traceability lot within the records of whoever assigned it. The place where it was assigned is called the traceability lot code source.

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21 CFR 1.1310 (definiciones FSMA 204 / FSMA 204 definitions)

U

USDA FSIS (Food Safety and Inspection Service)

The US Department of Agriculture (USDA) agency that carries out the Federal Meat Inspection Act, the Poultry Products Inspection Act and the Egg Products Inspection Act. Its rules are in title 9 of the CFR, including HACCP under 9 CFR part 417.

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V

Validation

Obtaining and evaluating scientific and technical evidence that a control measure, a combination of measures or the whole food safety plan, when properly implemented, is capable of effectively controlling the identified hazards.

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21 CFR 117.3 (definiciones / definitions)

Verification

Methods, procedures, tests and other evaluations, in addition to monitoring, that determine whether a control is or has been operating as intended and that establish the validity of the food safety plan.

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W

Warning Letter

A notice FDA sends when it identifies what it believes are significant violations of federal requirements. It explains the concerns, gives the company a chance to correct them and requests a response within a set time; FDA publishes these letters on its website.

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FDA: About Warning and Close-Out Letters

Food safety glossary: FDA, FSMA and SQF terms

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