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U.S. FDA’s FSMA - How does it affect your business?

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#1 Simon

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Posted 16 February 2015 - 08:47 AM

U.S. FDA’s Food Safety Modernization Act - How does it affect your business?
Frank SchreursManaging Director, Consulting and Technical Services, NSF International

This Live Webinar is taking place: February 20, 2015 - 03:00 PM - 04:00 PM GMT (10 a.m. EST Start)

The U.S. Food Safety Modernization Act (FSMA) represents a major reform of the food safety regulations in the United States of America (USA). What are the new regulatory requirements under FSMA? How is your organization affected by these regulations? Join us for this webinar to uncover requirements under the new regulations and share information on how these regulations will impact the food produced, imported into and exported to USA. 

 


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#2 Simon

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Posted 20 February 2015 - 08:54 PM

Links to further resources as promised.

 

The first link is an online tool for facility and system readiness assessment that people can follow along to get an understanding of where they are in terms of readiness for FSMA compliance and what steps they would need to take to achieve complete compliance. Hoping this helps!

 

And some of the questions captured from today's webinar...Frank will follow up on these in due course.

 

 


Mark
Sec.112 is Allergens and it starts off with the following early childhood education program.--The term "early childhood education program"? 

 

Thies
The risk categories are still under proposal and not final. How can we still lobby to get a material included or excluded? 

Antonella
Hi, Frank. Is the FSMA strategic for the upcoming trade agreements between EU and North America, such as the TTIP? 

Rajesh
Is inspection will be mandatory? 

Mahmoud
Are any of GFSI RECOGNIZED SCHEME enough for supplying from outside USA? 

Jon
Any information about when the lamb meat export ban will be lifted to export it from the UK please? 

nourreddine
Did FDA had capacities to ensure the compliance of all products (domestics products, importer, exporter..) 

 

Bruce
Where can I find risk categories for various foods? And the difference in FSMA requirements for each. 

Murali Krishna Bujji
What is the difference between import alert and import refusal

Mark
I can't find real clear cut info about adding radioactive into the HACCP program.          

Thies
There is so much still not final on certification and auditing, so difficult to see if GFSI will be sufficient. Would be disappointing if it is not.                

Chris
What is the radioactive program?          

Mark
Only difference with the New FSMA is this radioactive program                

Andrea
What about BRC issue 7, with its new requirements on food defense, adulteration?          

Javier
Isn't HARPC only in the USA?         

Jeremy
With the limited funds available to the FDA they cannot immediately cover all areas discussed today; do you know of their priorities? What areas should companies prioritise first?          

Carlos Armas
Simon/Frank: What could be some impacts on 3rd Party Auditing firms, as it relates to FSMA       

         

Kip
Have the thresholds for who is exempt been finalized? I work with many small/medium sized farms and packing houses, and all of them think they're exempt                

Brian Heldt
If FDA doesn't have the finances for increased personnel, why do they think that state, municipal, or foreign entities will

 

Steve
My understanding is if you are listed on the shipping documents as "In care of" the owner of the ingredients is considered the importer....Simon is this correct?         

 

Kirsten
Does FSVP apply to primary (food contact) packaging as well as ingredients?                

 

Kirsten
If manufacturing private label products, and the customer wants to send in their own ingredients (perhaps from out of USA), what is the manufacturer's obligation for verification

Kirsten supplier (foreign or domestic) -- will being certified to a GFSI scheme be sufficient or will the company buying the ingredient have to do their own audit?      

    

Rajesh
Is inspection gonna be mandatory for importers          

Magdalena
How it will affect manufacturers of food processing machinery? Any new req?          

Mark
WHAT ABOUT LEGAL WISE ARE WE AS AUDITORS HELD ACCOUNTABLE FOR OUR AUDITS IF ASKED BY FDA?         NO IT MENTIONS THAT IN THE FIRST SENTENCE IN FSMA ACT          

Mark
I AM HAVING ISSUES UNDERSTANDING SEC. 112 UNDER FSMA?    

Steve
I do not believe the auditing body can be held responsible. The CB is only auditing your food safety program and certifying you have a program in place following the standard in which you are audited by. The auditor only sees a snap shot of your program and operation.                

Mark 


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#3 Charles.C

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Posted 20 February 2015 - 09:48 PM

Hi Simon,

 

I had a quick look at the Draft Methodological Approach link.

Unless FDA intend to use this document to issue their own  reference list of HR Foods, IMO it looks more like a bad joke from a normal user's POV. Unbelievable.

 

Rgds / Charles


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#4 MWidra

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Posted 23 February 2015 - 03:56 PM

Hi Simon,

 

I had a quick look at the Draft Methodological Approach link.

Unless FDA intend to use this document to issue their own  reference list of HR Foods....

 

Rgds / Charles

That is exactly what this document is, a statement of the processes they will use to determine the list of HR foods which will be subject to the different controls than low risk foods.  In the US, the government is required to be transparent to stakeholders about the processes they use (unless they are the CIA or FBI or NSA, lol) so they have to publish a document saying how they are gonna do it.

 

That is what this document contains, the analysis they will use to develop that risk.  It is not up to the manufacturers to determine the FDA list of high risk foods, so we don't have to worry about following this template.  The FDA does not trust all manufacturers to perform their own analysis and make up their own list.  That is an invitation to abuse and a list that has not been developed in an unbiased fashion.  We've been burned before, corporations are not always to be trusted.

 

Hope that sheds some light on the US regulatory process.

 

Martha


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#5 Simon

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Posted 17 March 2015 - 08:56 PM

Frank Schreurs answers to the questions raised during the webinar.

 

1. Mark

 

Sec.112 is Allergens and it starts off with the following early childhood education program.--The term "early childhood education program"?

 

I suspect this is a generic term to encompass all pre-school types of programming and if a manufacturer has contracted to provide food to such a program then the need for allergen control would be required.

 

2. Thies

 

The risk categories are still under proposal and not final. How can we still lobby to get a material included or excluded?

 

The best avenue would be through your relevant trade associations as they have an already established conduit to FDA for commenting. The public comment period for the specific documents (Docket) has ended and is no longer available through the FDA website.

 

3. Antonella

 

Hi, Frank. Is the FSMA strategic for the upcoming trade agreements between EU and North America, such as the TTIP?

 

I have not seen anything to suggest it is a major player in the negotiations of any of the trade agreements. There may be some upcoming trade dispute cases if any country exporting to the U.S. feels that it imparts an unfair trade barrier. The dispute resolution aspect of trade agreements is intended to handle specific cases.

 

4. Rajesh

 

Is inspection will be mandatory?

 

Inspection by FDA or a recognized representative of FDA is part of FMSA. The frequency and who will do it has not been published, other than FMSA does require FDA to partner with various stakeholders to accomplish this requirement.

 

5. Mahmoud

 

Are any of GFSI RECOGNIZED SCHEME enough for supplying from outside USA?

 

They will not initially be “enough” to gain automatic entry. The future application of the Voluntary Quality Importer Program (VQIP). Below is an excerpt from FDA site: The FDA will use certifications issued by accredited third-party auditors for two purposes under FSMA. First, section 302 of FSMA authorizes the FDA to create the Voluntary Qualified Importer Program (VQIP), which provides for expedited review and entry of food into the United States. In order to participate in VQIP, importers must import food from certified facilities. The criteria and procedures for VQIP participation are outside the scope of the third-party auditor rulemaking. The FDA will issue a draft guidance establishing VQIP in the future and will solicit public comment on VQIP at that time.

 

6. Jon

 

Any information about when the lamb meat export ban will be lifted to export it from the UK please?

 

None that I can comment on.

 

7. nourreddine

 

Did FDA had capacities to ensure the compliance of all products (domestics products, importer, exporter..)

 

It is a publically known fact that FDA does not currently have the capacity to monitor compliance to all products produced in the U.S. or imported to the U.S. Hence the FSMA requirement that FDA seek partnerships to assist in this.

 

8. Bruce

 

Where can I find risk categories for various foods? And the difference in FSMA requirements for each.

 

A definitive list has not been published since the methodology to classify a product/process has high risk has not yet been implemented. One could make their own preliminary determination by reviewing the draft methodologies. Here is a link to get the pdf document:

http://www.fda.gov/F...A/ucm380210.htm

 

9. Murali Krishna Bujji

 

What is the difference between import alert and import refusal

 

Import Alert: The alert lets FDA field staff know that the agency has enough evidence or other information to refuse admission of future shipments of an imported article. Veneziano says there are a variety of factors that could lead FDA to place a product, manufacturer, shipper, grower, geographical area, and/or country on import alert. For example, questions could have been raised in an inspection of the manufacturing site or flags could have been raised by a recall of products already on store shelves. There could be a history of problems with no signs that appropriate actions were taken to remedy the cause, or problems related to production, such as harvesting from water that appears polluted. Once a shipment is refused admission to the U.S., the importer has an opportunity to introduce evidence, within 10 days, to overcome the appearance of a violation. During this time, the product is either held at a warehouse or at the importer’s premises and cannot be distributed. If the shipment is not proven to be safe, it must be destroyed or exported within 90 days.

 

Import refusal - FDA can refuse admission into the U.S. of imported products if, among other reasons, the product appears to be adulterated or misbranded.

 

10. Mark

 

I can't find real clear cut info about adding radioactive into the HACCP program.

 

The proposed rule would include a radiological agent in the definition of “hazard” because FSMA includes radiological hazards as an example of known or reasonably foreseeable hazards that may be associated with the facility.

 

11. Andrea 

 

What about BRC issue 7, with its new requirements on food defense, adulteration?

 

These changes align well with FSMA requirements and are not a duplication.

 

12. Javier

 

Isn't HARPC only in the USA?

 

The inclusion of preventative controls is a requirement in all HACCP plans for any company that will be exporting to the U.S.

 

13. Jeremy

 

With the limited funds available to the FDA they cannot immediately cover all areas discussed today; do you know of their priorities? What areas should companies prioritise first?

 

The FDA compliance approach will not be parceled out in terms of parts of any specific regulations. Hence companies should be prepared to meet all of the requirements that would apply to their type of operation.

 

14. Carlos Armas

 

Simon/Frank: What could be some impacts on 3rd Party Auditing firms, as it relates to FSMA

 

Auditors may be required to be approved specifically by FDA either through a competency exam or other assessment methods. Auditors, through their associated CB’s, may be approved through the CB accreditation process, similar to how it is currently applied to specific schemes that a CB is licensed to.

 

15. Kip

 

Have the thresholds for who is exempt been finalized? I work with many small/medium sized farms and packing houses, and all of them think they're exempt

 

The exemption thresholds are illustrated in the final few slides of the presentation, as they have currently communicated by FDA.

 

16. Brian Heldt

 

If FDA doesn't have the finances for increased personnel, why do they think that state, municipal, or foreign entities will?

 

Some of these other entities will look to sub-contract to FDA through various shared financing models.

 

17. Kirsten

 

Does FSVP apply to primary (food contact) packaging as well as ingredients?

 

Applies only to ingredients and finished product production facilities. These facilities may require food contact packaging suppliers to also comply as part of their supplier monitoring programs.

 

18. Kirsten

 

If manufacturing private label products, and the customer wants to send in their own ingredients (perhaps from out of USA), what is the manufacturer's obligation for verification

 

Kirsten supplier (foreign or domestic) -- will being certified to a GFSI scheme be sufficient or will the company buying the ingredient have to do their own audit?

There would need to be clear lines of responsibility spelled out in the contract with the customer as to who is the importer. It is the importers responsibility to ensure the ingredient manufacturer is compliant.

 

19. Rajesh

 

Is inspection gonna be mandatory for importers

 

Yes, they will be subject to some frequency of inspection/audit.

 

20. Magdalena

 

How it will affect manufacturers of food processing machinery? Any new req?

 

FMSA does not regulate equipment manufacturers. They will still need to meet the requirement of their customers, who may be under FSMA regulations.

 

21. Mark

 

WHAT ABOUT LEGAL WISE ARE WE AS AUDITORS HELD ACCOUNTABLE FOR OUR AUDITS IF ASKED BY FDA? NO IT MENTIONS THAT IN THE FIRST SENTENCE IN FSMA ACT

 

If the auditor is contracted to a CB, industry will need to include language in client contracts that states that if there a imminent risk to consumer safety the auditor may be required to report this directly to FDA. At issue is or legal right to do so if not stated in a business to business contract.


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Simon Timperley
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#6 MWidra

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Posted 18 March 2015 - 12:36 PM

Frank Schreurs answers to the questions raised during the webinar.

 

 

8. Bruce

 

Where can I find risk categories for various foods? And the difference in FSMA requirements for each.

 

A definitive list has not been published since the methodology to classify a product/process has high risk has not yet been implemented. One could make their own preliminary determination by reviewing the draft methodologies. Here is a link to get the pdf document:

http://www.fda.gov/F...A/ucm380210.htm

 

 

 

10. Mark

 

I can't find real clear cut info about adding radioactive into the HACCP program.

 

The proposed rule would include a radiological agent in the definition of “hazard” because FSMA includes radiological hazards as an example of known or reasonably foreseeable hazards that may be associated with the facility.

 

 

 

 

 

 

 

The FDA has some risk assessment software available that they just upgraded to include more factors.  I have not personally used it, but it may be useful for anyone working on their FSMA risk assessments.

 

http://foodrisk.org/...ssessment-tool/

 

They had a webinar, which was technical in nature, but the replay of that webinar is available at that link.

 

Martha


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"...everything can be taken from a man but one thing:  the last of the human freedoms--to choose one's attitude in any given set of circumstances, to choose one's own way."  Viktor E. Frankl

 

"Life's like a movie, write your own ending."  The Muppets


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#7 Simon

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Posted 18 March 2015 - 02:53 PM

That's useful, thanks Martha.


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