Tag Archives: food safety modernization Act

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FDA Issues Final Guidance for Foreign Supplier Verification Programs

By Food Safety Tech Staff
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The FDA has issued its final guidance for the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. FSVP, which is part of the FDA Food Safety Modernization Act, makes importers accountable for verifying that foreign suppliers are producing food in a manner that meets U.S. safety standards.

This guidance includes recommendations on the requirements to analyze the hazards in food; evaluate a potential foreign supplier’s performance and the risk posed by the food; and determine and conduct appropriate foreign supplier verification activities.

The guidance also addresses how importers can meet modified FSVP requirements in a variety of categories, such as requirements for importers of dietary supplements or very small importers.

In response to comments received to the 2018 draft guidance, changes were made to the final guidance, including providing additional clarification regarding to what food the FSVP regulation applies; what information must be included in the FSVP; and who must develop and perform FSVP activities.

“Food” covered under FSVP includes:

  • Articles used for food or drink for humans or other animals,
  • Chewing gum, and
  • Articles used for components of any such article.

Training materials, developed in collaboration with the Food Safety Preventive Controls Alliance (FSPCA), are available to help facilitate FSVP compliance by importers.

Download the final guidance here.


FDA Updates Food Defense Plan Builder to Support Compliance with Intentional Adulteration FSMA Rule

By Food Safety Tech Staff
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Attend the Food Defense Plenary Panel Discussion at the 2019 Food Safety Consortium | Tuesday, October 1, 2019Today FDA released an updated version of its Food Defense Plan Builder in efforts to help companies comply with the International Adulteration FSMA rule. Version 2.0 of the tool includes the following sections to help food facility owners and operators in developing a facility-specific food defense plan:

  • Facility Information
  • Process/Product Description
  • Vulnerability Assessment
  • Mitigation Strategies
  • Food Defense Monitoring Procedures
  • Food Defense Corrective Action Procedures
  • Food Defense Verification Procedures
  • Supporting Documents
  • Signature

The tool is for use on a computer, and FDA states that it does not have access to any content or documents used with the tool, nor does it track or monitor how the tool is being used. The agency also emphasizes that use of this tool is not required by law and its use does not mean that a company’s food defense plan is FDA approved or compliant with the IA rule requirements.

The original version of this tool was released in 2013. FDA will be conducting a demonstration of the Food Defense Plan Builder v. 2.0 during a webinar on October 10.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

What to do Now to Migrate from HACCP to HARPC

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

There is much talk about HARPC – Hazard analysis and risk-based preventive controls – and how food companies need to either elevate their existing Hazard Analysis at Critical Control Points (HACCP) program, or formulate a new HARPC-based food safety plan, in order to comply with proposed rules under the U.S. Food Safety Modernization Act in the

In a recent FSMA Fridays discussion, Dr. David Acheson and Melanie Neumann of The Acheson Group elaborated along with SafetyChain Software’s Barbara Levin, how HARPC differs from HACCP and what companies can start doing now to be prepared. We present below some excerpts.

How are HACCP and HARPC different?

The key term is that HARPC is risk –based. While HACCCP is more prescriptive, based on the seven-step process, the risk-based analysis requires moving outside of those seven steps to think of how else can I manage risk. Also, under HARPC, it’s no longer deemed sufficient to have a HACCP plan – you need to have a more exhaustive food safety plan.

How should F&B companies approach migrating HACCP to HARPC plans?

In the proposed FSMA rules, FDA has changed the language of defining how and which products should be monitored from ‘reasonably likely to occur,’ which is HACCP type terminology, to ‘significant.’ FDA is doing this in an attempt to differentiate the required HARPC-based food safety plan from traditional HACCP plans. This requires food companies to look at hazards along the whole supply chain – from when we are receiving food to when we are shipping it out (and not just at control points). For instance, environmental controls in a ready-to-eat foods processing area is covered now, which is beyond the traditional HACCP area. So look at those risks in the processing facility and ask if they are significant risks.

Who is the Qualified Individual and how does this impact the HARPC approach?

This is the million dollar question! FDA hasn’t come out with a clear definition yet – only vaguely referring to this person as ‘qualified by training or experience.’ However, this person has a lot of responsibility on their plate – they are responsible for preparing a robust food safety plan that identifies and controls risks, for putting in place corrective actions and validate these, and for doing a reanalysis of the food safety plan as needed. F&B companies need to ask if they have the right person driving this bus. You do need somebody in your business who is capable and qualified to do this, or FDA allows you to use an outside expert as the Qualified Individual.

What will FDA expect to see with HARPC when they come in to see FSMA being enforced?

Once FSMA is implemented (possibly) by August 2016, FDA inspectors can come into F&B facilities and ask to see food safety plans, and details of the HARPC plans. They would want to understand what the process is, what the hazards are, and how and if you are controlling these, and if you are thinking of these hazards from a risk-based preventive controls strategy.

What are top three things that companies should be doing to comply today?

As described often, HARPC is an evolution of HACCP or HACCP on steroids. The first thing you need to do is understand what you are being asked to do with HARPC. Make sure you get the strategy here. Step two, is to get together a team to do this to figure out where your risks are, if they are significant, and build these into food safety plan. Step 3 is look at your current systems and structure. Do you have these now identified significant risks controlled? Have you determined what the controlling steps are, and put in place these preventive controls? Ask yourself if you are controlling these risks, monitoring them, putting in place corrective actions and validating them?

Final point: we often hear people saying, ‘I am going to wait. We are going sit out and watch how the rules evolve.’ But our advice is Do Not Wait! We have a lot of insight on how the final rules are going to pan out and what the compliance requirements will be. So start working now.

For more on this discussion, click here.

No Industry Fees for FSMA – Food Groups Write to Congress

A coalition of nearly 60 food groups, has now written to the Congress, urging the Senate and House of Representatives to fund the Food and Drug Administration without introducing new fees to the food industry.

The Obama administration budget proposal for fiscal year 2016 includes a proposal to impose a food facility registration and inspection fee to fund agency activities related to the Food Safety Modernization Act. The agency projects it would collect $60 million in fiscal year 2016. A food import fee was also proposed, with projected revenues of $103 million in FY 2016.

A coalition of nearly 60 food groups, has now written to the Congress, urging the Senate and House of Representatives to fund the Food and Drug Administration without introducing new fees to the food industry. The group — including the United Fresh Produce Association, the Food Marketing Institute and the American Farm Bureau Federation — is arguing that the new fees will hurt food producers and consumers.

Delivered before the March 4 House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations subcommittee hearing, the letter explained that Congress has previously rejected efforts to impose new regulatory fees on food makers and distributors to fund FDA’s food safety programs and should do so again.

“We believe if FDA requires additional funds in FY 2016 to support food inspection activities and implementation of the Food Safety Modernization Act, the administration should seek all such funding through the Congressional budget and appropriations process, rather than asking for authorization of new regulatory taxes that Congress has repeatedly rejected,” the letter said.

Rick Biros, President/Publisher, Innovative Publishing Co. LLC
Biros' Blog

Two New Proposed Rules. In about a year, it’s HACCP for everybody!

By Rick Biros
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Rick Biros, President/Publisher, Innovative Publishing Co. LLC

Some of the most boring press conferences are when coaches face the press after a game. Most of the questions coming from the press corps are not well thought out. It’s like they are just asking questions just because they can. While the coaches are required to be accessible to the press, I appreciate it when they put some personality and thought into their answers. One time, former Chicago Bears coach Mike Dikta confronted a reporter with “What’s the difference between a three-week-old puppy and a sportswriter? In six weeks, the puppy stops whining.”

The reason some of us watch these press conferences is for the remote possibility the coach actually says something interesting or even better, when they break down under the weight of all the really stupid questions. There was a Coors Light commercial series with coaches completely losing it. Football fans might remember former Indianapolis Colts coach Jim Mora whining “Playoffs?”  See video 

Bill Parcells, former head coach of the New York Giants was classic. Parcells had no patience for stupidity and used to yell at reporters, “That’s a really stupid question. Next question!”

Dr. Margaret Hamburg, Commissioner and Michael Taylor, Deputy Commissioner from FDA held a press conference Friday, January 4 announcing two new proposed food safety rules that I had the pleasure of attending. Hamburg said “This is a very big step in direction of creating a comprehensive prevention-based food safety system.”

The first rule proposed would require makers of food to be sold in the United States, whether produced at a foreign- or domestic-based facility, to develop a formal plan for preventing their food products from causing foodborne illness. The rule would also require them to have plans for correcting any problems that arise. A.K.A. HACCP. 

In the past, FDA enforced HACCP in seafood and juice. USDA enforced HACCP in meat and poultry. In about a year, it’s HACCP for everybody! Here’s the link to the rule: http://www.fda.gov/Food/FoodSafety/FSMA/ucm334115.htm

The second proposed rule proposes enforceable safety standards for the production and harvesting of produce on farms. FDA is targeting the five pathways of microbiological contamination: water, worker hygiene, soil materials, animals and packing houses – http://www.fda.gov/Food/FoodSafety/FSMA/ucm334114.htm

We are now in a 120-day review period for the two proposed rules. Taylor said, it typically takes the agency about a year to review the comments and issue the final rule.  So, we are looking at HACCP being the law of the land in all segments of the food industry in 2014.

The question food companies need to ask is not what will FDA’s HACCP rule look like in 2014, but how good is our HACCP plan now? Hamburg said the preventive controls rule is basic common sense food safety. Use 2013 as the year to revisit your HACCP plan. When was it last revised? What type of records are you keeping? Simply, if you have a good HACCP plan in place now, regulatory compliance should not be difficult. 

In the press conference, Hamburg said that additional rules to follow soon include new responsibilities for importers to verify that food products grown or processed overseas are as safe as domestically-produced food, and accreditation standards to strengthen the quality of third-party food safety audits overseas.

Unlike many coaches after a game, Hamburg and Taylor did a good job communicating their points. However, it was the consumer press with their questions that brought to mind how well composed Hamburg and Taylor stayed handling questions such as “How many foodborne illnesses will be prevented if these rules are carried out,” “How much does this cost,” and the best one, “How will FDA make sure farms will prevent wildlife from contaminating fields?” They remained cool and politely answered the questions. I guess they have more patience than me.

That last question made me think, how would Bill Parcells answer that? Picture this old grouchy guy who doesn’t care what anybody thinks of him rephrasing the question: “You want me to tell you how my agency will make sure farms are preventing wildlife from walking through or flying over the fields?? Next question!”