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Food Safety Modernization Act (FSMA) Highlights

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George @ Safefood 360°

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Posted 08 August 2011 - 09:51 PM

The FDA Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4th, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.

In the six month since it was signed into US law the relevant authorities have been putting in place various actions required to enforce the act. The total cost of the bill is estimated to be $1.4 billion and represents the biggest change to oversight of food safety in the US since 1938.

Its impact for regulatory bodies such as the FDA is significant. The impact on food processing businesses will also be felt. It is a fact of modern food production and supply that when regulators introduce new laws the burden on food plants increases. Often this extra burden is carried with the existing resources. In this discussion topic I would like to summarise and highlight the main changes and objectives of the Act. It may prove useful to food plant managers, students and food safety professionals. Feel free to discuss any aspect of the Act.

The requirements of the Act can be divided into two main areas:

• Food Safety
• Food Defense


The first area under food safety is Prevention. This is the main fundamental shift of the US's management of food safety and risk. The Act will introduce the following:

1. Expansion and clarification of the FDA's records inspection authority.
2. Introduction of registration renewal for food plants every two years and potential FDA inspection as a condition for renewal.
3. Hazard Analysis and prevention control implementation at critical control points every three years.
4. Performance standards review every two years.
5. Production and harvesting standards for raw agricultural commodities.
6. FDA to notify the Department of Homeland Security (DHS) in the event of FDA refusal to admit foods into the U.S.


The Act was driven by a number of serious food outbreaks and the States response to these incidents. The Act will introduce improvements including:

1. Risk based prioritization of plant inspections.
2. Development and maintenance of accreditation standards for laboratory food testing.
3. Traceback and record keeping requirements to prevent/mitigate foodborne illness outbreaks.
4. Foodborne illness surveillance system enhancements
5. Mandatory recall authority for adulterated or misbranded products.
6. FDA to provide support to state and local governments in response to outbreaks.


The Act will bring significant changes beyond the borders of the U.S. Companies exporting food into the U.S. and those agents importing foods will be required to meet specific demands including:

1. Importers to undertake risk-based foreign supplier verification program
2. Voluntary qualified importer programme for expedited review and importation for importers.
3. Import certification of foreign countries' controls and standards to verify implementation.
4. Inspection of foreign food facilities to verify federal compliance and accreditation of third party auditors to carry out those inspections.
5. Work with DHS to develop a strategy to identify smuggled foods to prevent entry.

I will add a summary of the requirements of the Act in the area of Food Defense in a couple of days.


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Dr Ajay Shah

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Posted 09 August 2011 - 07:17 AM

Thanks for the information George. It is much appreciated.


Dr Ajay Shah.,
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Managing Director & Principal Consultant
AAS Food Technology Pty Ltd

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Posted 09 August 2011 - 07:56 AM

Thank you very much for sharing :clap:


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Posted 09 August 2011 - 10:34 AM

Dear George,

Interesting stuff.

I believe most of the third section is an upgraded, re-packaging of the decades+ "Memorandum of Understanding" (MOU) concept.

My experience is primarily in seafood where I think one impediment to the US system ( in addition to the qualification process itself) has frequently been related to the eventual benefits, eg the ability of certificated exports to have "smooth" access at destination.
Another problem, I think, has been that the stated safety requirements have been required to be seen as even-handed, ie equally applied / attainable for local producers / products.
(Actually, I believe the maintenance at destination, eg by the importer, of documented haccp systems for seafood exported to US has been mandatory for many years already.)

The practical consequence seems to have been that many (most?) importing nations seem to prefer the (now) widely found, EC-type system. This sets up a mutually agreed, origin-based, specific government "Competent Authority" to control the safety and quality of goods exported to the EC. The performance of the Authority is regularly (locally) audited by EC personnel on a world-wise basis and by occasional analyses of products at destination (eg the well-known "rapid alert" system.)

Rgds / Charles.C

Kind Regards,



George @ Safefood 360°

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Posted 09 August 2011 - 10:55 PM

Charles - I tend to agree with you. I suppose the Act for the first time sets a clear legal framework for the measures you describe. My experience with the FDA conducting inspections and certifications of exporting plants has been one of a random process and focused mainly on raw meat. I think the move towards the EU model whereby the FVO of the Commission conduct planned and coordinated campaigns in specific nations and processing plants is a positive move by the US. That's assuming of course that local US farmers don't agree with the Irish farmers position on the role of the EU in regulating imported meat products...

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Posted 10 August 2011 - 06:24 AM


This information is quite good, especally for us in the third world, who would not have the required interpretation of the law. As for me, I am on this site to learn this things and have a better understanding.


George @ Safefood 360°

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Posted 02 September 2011 - 10:10 PM


Just to round off this post, the following is a summary of the provisions contained in the Act under the heading of Food Defense.

The application of these provisions covers the following:

  • Food indentified with clear vulnerabilities
  • Bulk/batch production food prior to final consumer packaging.
  • Items with high risk of intentional adulteration (IA).
In regard to IA items, these are determined by:

  • Conducting vulnerability assessments
  • Uncertainties, risks, costs, benefits with guarding against IA
  • Determining best strategies necessary to protect against IA
The Act will be underpinned by a number of food defense strategy goals including:


  • Conducting vulnerability assessments on foods
  • Mitigate vulnerabilities in the food chain
  • Improve communication and training
  • Develop and conduct exercises to test decontamination and disposal plans
  • Develop event modeling tools to improve event consequent assessment
  • Prepare risk communication tools and public outreach


  • Identifying contamination at the earliest possible time
  • Conducting surveillance to prevent spread of disease

Emergency Response

  • Immediate outbreak investigation
  • Preventing disease spread
  • Organising, training and equipping emergency response teams
  • Designing, developing and evaluating training and exercises carried out under food defense plans


  • Working with private sector to develop business recovery plans
  • Conducting exercises for food defense plans geared toward long-term results
  • Rapidly removing and effectively disposing of contaminated products
  • Decontamination and restoration of affected areas.
George Howlett

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