GFSI と認証
For the last of the seven proposed core regulations, the comment periods have ended. The US Food and Drug Administration (USFDA), have stated that they will be re-proposing parts of the Preventive Control rule, or producing supplementary proposals, for both the Human and Animal, Produce Safety and Foreign Supplier Verification programs. These amendments may be issued in September 2014, and are the result of issues raised during the comment period. Despite this, there is enough information in law and the seven core proposals for the industry to start acting, to ensure compliance.

The timeframe for the US FDA is the statutory deadline to produce the final rules by the specific dates as listed in Table 1. The effective dates are 60 days after the final rules are published. The compliance dates are one to three years from the effective date, with some parts being extended further, dependent on the size of the operation and personnel numbers for the parameters established in the rules. Full compliance will take place from November 2016 to August 2019 for the seven core rules, with some parts being extended further, for example, the water testing requirements in the Produce Safety standard.

The US FDA’s published requirement is that all facilities selling food in or into the United States of America should establish food safety programs to prevent foodborne illnesses to both human and animals. The preventive control rules and the produce safety rules establish the framework to accomplish this and the other rules build on this. While the US FDA is willing to work with the industry, examples being the Brewing1, artisan cheese2 and produce industries3, the Agency still requires the establishment of food safety systems that will protect the public. This is clearly stated in the Operational Strategy for Implementing FSMA which starts with the sentence “Protecting Public Health by Strategic Implementation of Preventive-Oriented Food Safety Standards”.4

With the rules having been discussed in full, the requirements are relatively clear but the objectives can seem problematic to large companies and impossible to small ones. In acknowledgement of this, the US FDA established the Food Safety Preventive Control Alliance5, to help the smaller companies by providing them with appropriate information. However this will not be forthcoming until possibly months after the final rules are published. The US FDA is stressing that they will be educating while they investigate and encouraging facilities to correct problems while their officials are still on site. A new tool is also being developed by US FDA, in the form of deficiency letters to be sent from a district office to a company that has been investigated. This is intended as notification of deficiencies during inspections, and their expected resolution dates.

The major retailers and manufacturers in the industry have been working to achieve the same goals that the US FDA is asking for. The industry developed the Global food Safety Initiative (GFSI) which established standards and benched audit programs against these standards. Additionally, a system of checks and balances has been established to help assure that all parties involved are doing what needs to be done. Realizing the difficulty of implementing these systems, most of the certification bodies and auditing programs have developed training programs to assist their implementation. Additionally, since these audit programs are well established, there are consultants who can provide further assistance in compliance to these programs.

Typically, a food safety program in compliance with a GFSI audit covers most of the FSMA requirements but the issue of the program’s intentional adulteration still needed to be addressed. Because this was a global issue, GFSI was working with this at the same time that US FDA were developing their proposal. The concepts of both the US FDA and GFSI are very similar, whereby the threat and/or vulnerability of the systems and facility must be evaluated, using the HACCP concepts in order to guard against intentional adulteration. GFSI calls this VACCP (vulnerability/food fraud) and TACCP (threat/food defense).6

The industry members associated with the GFSI program continually strive to improve the food safety programs in order to provide the public safe and affordable food which is the same objective that the US FDA will be achieving with FSMA, so it is no coincidence that the programs are going to be very similar.


Preventive Controls (Human Food) 08/30/2015
Preventive Controls (Animal Food) 08/30/2015
Produce Safety 10/31/2015
Foreign Supplier Verification Program 10/31/2015
Third Party Accreditation 10/31/2015
Sanitary Transport of Food and Feed 03/31/2016
Intentional Adulteration 05/31/2016



About SGS Food Safety Services
Leveraging a global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions, including analytical testing, inspections, audits, certifications and technical support. SGS continually invests in world class testing capabilities and state-of-the-art technology to help reduce risks, and improve food safety and quality.

Jim Cook
Food Scientific and Regulatory Affairs Manager
SGS North America, Inc.
SGS Food Services
1 Washington Ave.
Fairfield, NJ 07004
P- 973-461-1493
e-mail: このメールアドレスはスパムボットから保護されています。閲覧するにはJavaScriptを有効にする必要があります。




  • GFSI WebSeries: A Tale of Mexican Coffee & Global Certification
  • GFSI WebSeries: Cocoa for the Masses - from Nigeria to Global Markets



  • GFSIは2020年のグローバル・マーケット・アワードの応募申込を開始しました! - 2019/05/09



  • 「私のボスはアメリカの消費者です」:フランク・イアナスがウォルマートの専門知識をFDAにどうやってもたらしたか - 2019/04/30



  • 2020 GFSIカンファレンスで業界リーダーと一緒にステージに上がる - 2019/04/29





  • サラヤ株式会社-フードバリューチェーンの構築に向け、日本のノウハウをアフリカへ!-(GFSIレポート) - 2019/05/16

    開発途上国の農林水産業・食産業の発展に貢献するため、生産から加工、流通、消費に至るフード バリューチェーン(FVC)構築の重要性が指摘されています。 今回、農林水産省の補助事業として展開する「アフリカ等のフードバリューチェーン課題解決型市場開拓事業」に賛同し、プロジェクトを立ち上げたサラヤ株式会社様にその経緯、今後の活動方針をうかがいました。


  • 日本発のステップアップ食品安全マネジメントスキームを日本、アジアへ~食品安全のボーダーレス化を目指して(CPOインタビュー② - 2019/05/02

    一般財団法人食品安全マネジメント協会(JFSM)の認証プログラム「JFS-C (EIVセクター)」が、2018年10月末にGFSIに承認されました。これを受けて、同協会の理事長・西谷徳治氏、事務局長兼技術本部長・大羽哲郎氏、普及推進本部長・仲谷正員氏に、その経緯、今後の活動方針や抱負をうかがいました。

    一般財団法人食品安全マネジメント協会(JFSM)の認証プログラム「JFS-C (EIVセクター)」が、2018年10月末にGFSIに承認されました。これを受けて、同協会の理事長・西谷徳治氏、事務局長兼技術本部長・大羽哲郎氏、普及推進本部長・仲谷正員氏に、その経緯、今後の活動方針や抱負をうかがいました。


  • 官民連携のオープン・ラボによる新たな政策提言の仕組み作り!! - 2019/04/09