Food Safety



With the implementation of new Food Safety Modernization Act, or FSMA, come many questions.  Here are just a few of the most frequently asked questions today that may be of interest to you and the FDA response to those questions.  For additional information, please be sure to visit

  1. What are the major requirements under the final preventive controls rules?

Everyone should be familiar with the final rules; they can be found at  Preventive Controls for Human Food At-A-Glance Fact Sheet

  1. The rule requires food facilities to have a written food safety plan that includes a hazard analysis and preventive controls. How often must that plan be reanalyzed?

At least once every three years. The facility must also review portions of the food safety plan under certain circumstances, such as when a preventive control is found to be ineffective.

  1. How are the preventive controls rules different from the Hazard Analysis and Critical Control Points (HACCP) system?

The Hazard Analysis and Critical Control Points systems that many FDA-regulated manufacturers have in place are the foundation of the preventive controls regulations. Although there are similarities between the FSMA preventive controls requirements and the HACCP system, not every provision is identical. For example, in HACCP systems, controls are applied at critical control points (CCPs), whereas preventive controls include controls at CCPs or controls other than those at CCPs that are appropriate for food safety.

  1. Product testing and environmental monitoring are in the final rules. When would companies need to apply these activities?

The preventive controls final rules require that a facility verify that hazards are being controlled and take corrective action to prevent contamination; and product testing and environmental monitoring are examples of steps a firm may take. A facility’s decision to conduct product testing, and to establish the frequency of such testing, will reflect a risk-based approach consistent with its hazard analysis. Consequently, the FDA expects that facilities that produce foods that have frequently been associated with outbreaks of foodborne illness or pathogen contamination, or produce ready-to-eat foods for which an effective preventive control cannot be implemented, would establish product testing programs more often than facilities that do not produce such foods.

Similarly, a facility that identifies an environmental pathogen as a hazard requiring a preventive control, for example, sanitation controls, would conduct environmental monitoring. Such a facility would decide what, if any, role product testing would play as a verification activity or as part of a corrective action as a result of positive findings from environmental monitoring, based on the facility, the food, the nature of the preventive control, and the role of the preventive control in the facility’s food safety system.

  1. Do I need to employ a preventive controls qualified individual (PCQI)?

The preventive controls for human food rule create new requirements for covered domestic and foreign facilities producing human food to develop and implement a food safety plan based on hazard analysis and risk-based preventive controls. In general, the rule applies to facilities that have to register under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). However, there are a number of exemptions and modified requirements that may apply (see 21 CFR 117.5 for exemptions that may apply to your facility).

If no exemptions apply to you, then you are required to have a PCQI develop and implement your facility’s food safety plan. A PCQI is a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum.

  1. My company has three separate food facilities. Are we required to have three distinct facility-specific food safety plans even though we produce the exact same food product at all three facilities?

The overall framework is directed to a facility. Thus, the preventive controls for human food rule establishes a requirement for every facility to have its own written food safety plan. Even if a corporation makes or holds similar products at separate facilities, it is unlikely that the separate facilities have exactly the same equipment and layout. Procedural instructions must be tailored to the equipment being used, and the layout of a facility including processing lines, technologies, and raw materials utilized as they will affect the approach to applying preventive controls such as allergen controls.


We are happy to announce that Noon International LLC has partnered with Nancy Scharlach and FSMA International to bring you a NEW online course that will help you develop and implement a credible and accurate FSMA food safety plan or HARPC plan.  The objective of this online course is to assist food processors in taking their current HACCP Plans and converting them to FSMA Preventive Controls Food Safety Plans, otherwise known as HARPC in an easy to follow step-by-step manner.  The difference between this NEW online course and other courses offered on the internet today is the way Nancy teaches this material with real-life examples and documentation. Nancy doesn’t just tell you WHAT TO DO, she shows you HOW TO DO IT.

More About Nancy Scharlach:

Nancy Scharlach is the President and Chief Technical Officer of FSMA International. She is a lead instructor with FSP Preventive Controls for Human Food, a lead instructor with FSPA Foreign Supplier Verification Programs, a lead instructor with the International HACCP Alliance and an SQF Global Food Safety Initiative Consultant for high risk processing.  She has audited, trained and consulted on site with over 2000 food processors and/or growers worldwide.


  1. 最終規則で義務付けられた予防的コントロールの主な要件は何ですか?

最終規則については、誰もが精通しておくべきです。次のサイトをご覧ください:Preventive Controls for Human Food At-A-Glance Fact Sheet(ヒト向け食品のための予防的コントロールについてのファクトシート)

  1. この規則では、ハザード分析と予防的コントロールを盛り込んだ食品安全性計画を策定することが、食品を取り扱う施設に義務付けられています。この計画は、どのような頻度で再評価する必要がありますか?


  1. 予防的コントロールに関する規則は、HACCP(ハザード分析および重要コントロールポイント)システムとどう異なるのですか?


  1. 製品試験と環境モニタリングが最終規則に盛り込まれました。これらの活動はいつ実施しなければならないのですか?



  1. PCQI(予防的コントロール資格者)を雇用する必要はありますか?



  1. 3カ所に食品施設を有していますが、すべての施設でまったく同じ食品を生産しています。その場合でも、施設ごとに3つの食品安全性計画を策定する必要がありますか?



Noon Internationalでは、このたびFSMA Internationalと提携し、同社のNancy Scharlach氏が講師を務める新しいオンラインコースをお届けすることになりました。FSMAの食品安全性計画またはHARPC(ハザード分析およびリスクベースの予防的コントロール)計画を確実に策定し導入するのに役立つコースです。これまでのHACCP計画をFSMAの予防的コントロール食品安全性計画であるHARPCに変えるための方法を、ステップ・バイ・ステップで解説します。この新しいオンラインコースは、実際の例や文書を教材にしている点で、インターネット上で提供されている他のコースとは異なります。「何を達成すべきか」だけでなく、「どのように達成すべきか」を学習できるコースです。

Nancy Scharlach氏の略歴:

Nancy Scharlach氏は、FSMA Internationalの社長兼最高技術責任者です。食品安全性予防的コントロール・アライアンス(FSPCA)のヒト向け食品のための予防的コントロールおよび外国サプライヤー認証制度で主任インストラクターを務めているほか、国際HACCPアライアンスの主任インストラクター、さらにSQFの高リスク加工処理を対象とした国際食品安全イニシアチブ(GFSI)コンサルタントも務めています。世界各地の2,000カ所以上の食品加工処理施設や生産者に対し、監査、研修、コンサルティングを提供してきた実績を有しています。


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