Tag Archives: FDA

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!”

FST Soapbox

The Fiscal Cliff’s Impact on Food Safety Management and FSMA

By Timothy Lozier
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One of the key areas that stands to lose in the fiscal cliff lies in food safety. We may be looking at a food chain that is less safe in 2013 that it is now.

The fiscal cliff is a series of tax cuts that are set to expire at the end of the year. It also would mean that spending cuts would take effect, which would have an impact specifically on Food Safety in the United States.

One of the key areas that stands to lose in the fiscal cliff lies in food safety. If we indeed fall off this fiscal cliff, there will be an 8 percent cut in spending for plant and animal health inspections, equaling about $70 million in cut funding. The Food Safety and Inspection Service agency could stand to lose about a billion dollars from their budget. We are also looking at about $3 million in spending cuts on inspectors. This means less food inspectors in the field, and as a result, less inspections. We are looking at a food chain that is less safe in 2013 that it is now.

FSMA: Still alive?

The other question that comes into play is whether the ever-delayed Food Safety Modernization Act (FSMA) is going to continue its path to law. We all know the delays that the FSMA has encountered since its introduction and passing in 2010. Now that the election is over, the administration seems more committed to the law than ever before.

However, this does not mean that we will see much movement in the coming year. The Office of Management and Budget has stated they plan to release the rules of the FSMA in early 2013, with a 60 day period of public comment. Once that is completed, FDA will take about a year or so to incorporate any public’s comment into the final rule. After that, other agencies will need to review these rules and approve them to actually make it into law.

So, it’s a year for FDA, and a year for other agencies – provided we don’t have any issues (which we will), we’re looking at 2015. More realistically, we’re looking for 2016-2017 timeframe for the FSMA to become a law.

That’s if we don’t see cuts stemming from a fiscal cliff disaster. The Obama Administration seems committed, stating “…We are working as expeditiously as possible to implement the food safety legislation we fought so hard for. When it comes to rules with this degree of importance and complexity, it is critical that we get it right.”

Law or not, food manufacturers are acting now

But whatever the result of government legislation and laws to be enacted for Food Safety Management, organizations are taking the necessary steps today to build processes that foster safer and higher quality food management. The Global Food Safety Initiative’s various schemes (BRC, SQF, IFS, etc.) are currently the gold standard for food safety in the industry today. Companies that are implementing these schemes are taking a proactive stance on food safety, and demonstrating a commitment to promoting safe quality foods in their operations.

Look at Canada

Canada seems to be on the right track these days. Just last month the Canadian government passed their food safety bill into law, which is a sister bill to the FSMA. The new law, which comes in the aftermath of a massive E. coli outbreak at a local farm, has many similar elements to what the U.S. is trying to do with the FSMA. The “Safe Food for Canadians” Act entails:

  • Better traceability in the food system, making it easier to recall products if safety issues arise somewhere in the food chain.
  • New record-keeping requirements for regulated facilities and more powers for inspectors to compel the production of documents in usable formats.
  • Tougher penalties for those who violate established safety standards, increasing maximum fines from $250,000 to up to $5 million, or even higher at the court’s discretion.
  • Registration for all importers, to add a greater degree of certainty to the food safety system.
  • More authority for the Canadian Food Inspection Agency (CFIA) to certify exporters, if required by other countries to facilitate trade.

There’s obviously more to the bill, but the highlights emphasize a tighter control and enhanced visibility to an organization’s Food Safety Management System, and their supply chain.

Take aways

Food Safety is under threat in the United States – spending and budget cuts are going to make a harder environment for promoting Food Safety;

The FSMA is still alive, but there’s a long road before we see any results on the dinner table;

GFSI still remains the key compliance area holding Food Safety processes together; and

Canada has made some movement into promoting Food Safety at the Federal level.

I sincerely hope that 2013 gives us a better view on Food Safety Management than it seems to be right now. But if not, it’s up to the producers to promote their continued commitment to adhering to the compliance standards that help them to operate a safe environment and produce the safest possible products for the food and beverage industry.