Preventive Controls for Human Food: The Basics

— Written By
en Español / em Português
Español

El inglés es el idioma de control de esta página. En la medida en que haya algún conflicto entre la traducción al inglés y la traducción, el inglés prevalece.

Al hacer clic en el enlace de traducción se activa un servicio de traducción gratuito para convertir la página al español. Al igual que con cualquier traducción por Internet, la conversión no es sensible al contexto y puede que no traduzca el texto en su significado original. NC State Extension no garantiza la exactitud del texto traducido. Por favor, tenga en cuenta que algunas aplicaciones y/o servicios pueden no funcionar como se espera cuando se traducen.


Português

Inglês é o idioma de controle desta página. Na medida que haja algum conflito entre o texto original em Inglês e a tradução, o Inglês prevalece.

Ao clicar no link de tradução, um serviço gratuito de tradução será ativado para converter a página para o Português. Como em qualquer tradução pela internet, a conversão não é sensivel ao contexto e pode não ocorrer a tradução para o significado orginal. O serviço de Extensão da Carolina do Norte (NC State Extension) não garante a exatidão do texto traduzido. Por favor, observe que algumas funções ou serviços podem não funcionar como esperado após a tradução.


English

English is the controlling language of this page. To the extent there is any conflict between the English text and the translation, English controls.

Clicking on the translation link activates a free translation service to convert the page to Spanish. As with any Internet translation, the conversion is not context-sensitive and may not translate the text to its original meaning. NC State Extension does not guarantee the accuracy of the translated text. Please note that some applications and/or services may not function as expected when translated.

Collapse ▲

In September of 2015, FDA published the regulation titled Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food, (referred to as the Preventive Controls for Human Food regulation) found in Part 117 in Title 21 of the Code of Federal Regulations. It is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the United States.

Who must comply? 

In general, all FDA registered food manufacturing/production facilities must comply with at least some portion of this rule.

  • All FDA-registered facilities must comply with Good Manufacturing Practices (cGMPs).
  • Businesses with annual sales >$1 million must comply with all parts of the rule and perform a hazard analysis as part of their food safety plan
  • Qualified Facilities (<$1 million total food sales) are exempt from hazard analysis and preventive controls.

What is required?

    • Training requirements include qualified individuals and Preventive Controls Qualified Individuals (PCQI)
    • Facilities that must comply with all portions of the rule must:
      • conduct a hazard analysis identifying known or reasonably foreseeable biological, chemical, physical hazards
      • identify hazards that require preventive controls (i.e., process, allergen, sanitation, supply-chain, recall)
      • conduct monitoring, corrective actions, and verification activities.
      • maintain records of all preventive control monitoring, corrective actions and verification activities.

When must I comply?

Size/Type of Business Compliance Date
Large businesses (average annual sales >$1 million) September 19, 2016
Small businesses (average annual sales >$1 million and <500 full time employees) September 18, 2017
Business subject to the Pasteurized Milk Ordinance September 17, 2018
Qualified facility (very small businesses with average annual sales <$1 million; exempt from hazard analysis and preventive controls) September 17, 2018 (cGMPs)