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|
|Foreign Supplier Verification Program||10/31/2015|
|Third Party Accreditation||10/31/2015|
|Sanitary Transport of Food and Feed||03/31/2016|
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.
Food Scientific and Regulatory Affairs Manager
SGS North America, Inc.
SGS Food Services
1 Washington Ave.
Fairfield, NJ 07004