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FSMA Overview


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#1 Chris Domenico

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Posted 19 March 2013 - 11:30 AM

The Food Safety Modernization Act was signed into law by President Obama on January 4, 2011. FSMA represents the most significant expansion of food safety requirements and FDA food safety authorities since the Food Drug and Cosmetic Act (FDCA) was originally introduced in 1938, and the total cost to create and implement is well over $1 Billion. FSMA’s significant changes grant the FDA new powers, one of which is the authority to require a food company to recall product that they (FDA) believe is adulterated and also the authority to suspend the registration (and essentially the entire operation) of any food facility they determine manufactured, processed, packed,or held food that has a reasonable probability of causing serious adverse health consequences or death to humans or animals. Due to the enormity of FSMA, it has taken – and will continue to take – the FDA several years to implement the full legislation.

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

• Food Safety
• Food Defense

FOOD SAFETY

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.

DETECTION and RESPONSE

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.

FOOD IMPORTS

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 program 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.

Your feedback, personal experience, and insight is very welcome and I look forward to it!

-Chris


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#2 Simon

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Posted 09 May 2013 - 12:12 PM

Hi Chris,

I've read the overview and have a few questions:

 

- Were there previously no (little) governmental controls / laws for the registration and regulation of food plants?

- What is the scope - just food production?

- How is FSMA being received in USA?

 

I suppose this is only reenfocing requirements that are now more commonly customer requirements e.g. food safety management systems, certification, GFSI standards etc.

 

I spotted this thanks to the "unreplied topics" button. :smile:

 

Regards,

Simon


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#3 Charles.C

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Posted 09 May 2013 - 02:33 PM

Dear All,

 

A collection of  one source’s (probably) chronological evaluation articles from Aug 2011 (last link) - April 2013 (1st)  at link below.

Mainly from US viewpoint I think but  with at least one exception (3rd link re-Canada, enter the  Safe Food for Canadians Act, SFCA :happydance: ).

 

Nice to see the arguments are still running (last link) over meaning of verification (now for FSMA). :smile:

 

http://www.foodsafet...-category/fsma/

 

Rgds / Charles.C


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Kind Regards,

 

Charles.C


#4 mgourley

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Posted 09 May 2013 - 09:11 PM

Hi Chris,

I've read the overview and have a few questions:

 

- Were there previously no (little) governmental controls / laws for the registration and regulation of food plants?

- What is the scope - just food production?

- How is FSMA being received in USA?

 

I suppose this is only reenfocing requirements that are now more commonly customer requirements e.g. food safety management systems, certification, GFSI standards etc.

 

I spotted this thanks to the "unreplied topics" button. :smile:

 

Regards,

Simon

Simon,

 

My two cents on this.

From the FDA:

On October 10, 2003, FDA issued an interim final rule to implement amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) (Pub. L. 107-188). Section 415 of the FD&C Act (21 U.S.C. 350d) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. to register with FDA by December 12, 2003.

 

See the whole document regarding Food Facility Registering here.

 

As to how it is being received, there are numerous articles/guidance documents, etc out there. The problem is that the whole Act is being rolled out in pieces, with the required comment periods for each piece. This means that facilities don't actually "know" what will be required until the final rule for each section is published.  This is causing some confusion, since some facilities don't want to go to the time and expense of complying with something that may not make it into the final rule. Many of the suggestions I have read, for example are encouraging facilities to NOT utilize their current HACCP plan for compliance with the Hazard Analysis and Preventive Controls piece of the legislation. The general take is that while the HA&PC piece is based on HACCP, it's not really going to be traditional HACCP. It's more than likely going to be regulatory HACCP.

 

The fact sheet for the Hazard Analysis and Preventive Controls piece can be viewed here.

 

I see that the comment period for this piece of the legislation has been extended to September 16th. It was to close on the 16th of this month. This adds another four months of confusion and lack of concrete direction and guidance.

 

FSMA WILL NOT be reinforcement of current requirements. Everything I have read points to it being the most significant change since the Food, Drug and Cosmetic Act was passed in 1938.

 

Marshall


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