Tag Archives: FDA

FSMA Sanitary Transport Rule: What You Need to Know

By Michael Biros
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Who does the proposed Sanitary Transport rule apply to and what will be its impact on the various transportation industries? This Q&A offers some insights and key takeaways from the critical rule.

On January 31, 2014, FDA announced the “Sanitary Transportation of Human and Animal Food” rule which will require certain shippers, receivers and carriers who transport food by motor or rail vehicles to take steps to prevent the contamination of human and animal food during transportation. The proposed rule establishes requirements for vehicle and transportation equipment, transportation operations, the exchange of information, training, written procedures and records. The proposed FSMA rule is broad and comprehensive and will likely have far-reaching effects across the food transportation industry.

In a recent FSMA Fridays webinar, sponsored by SafetyChain Software, Melanie Neumann and Jennifer McEntire, from The Acheson Group, answered some questions about the extent and implications of this rule.  We present some excerpts below. 

Who does the Sanitary Transport rule apply to?

Compared to other FSMA rules, the Sanitary Transport Rule’s coverage is broad and comprehensive. It will apply to businesses regulated not just by FDA, but by USDA as well. It will apply to food for human consumption as well as animal consumption. It will apply to both intrastate and interstate commerce. 

However there are a few exemptions: Companies with annual sales less than $500,000 and foods that are fully packaged and shelf stable are exempt. 

What impact will this proposed rule have on various transportation industries?

When it comes to Shippers and Carriers, this rule will affect everyone. Shippers need to establish and communicate with carriers about specific conditions for the food such as temperature control, cross-contamination control, hand-washing facilities for loading and unloading, etc. Carriers need to ensure that they are meeting the shipper’s requirements. They need to make sure equipment is appropriate and clean. Like other FSMA rules, this rule will require documentation. Carriers also need to complete a fair amount of training to establish how they can achieve these expectations. 

Receivers, historically, haven’t had a lot of responsibility in ensuring sanitary food transport. Now they have a regulatory obligation to do so. This rule will apply to anyone receiving food including retailers, food service, and small convenience stores. They will be required to actively participate and are subject to more regulatory oversight than they have had ever before. 

What is a waiver in the context of this rule and who might be eligible?

There are opportunities to receive a waiver and waive out of this rule. Those who qualify for a waiver are those who can prove that they are under other practices, protocols, and ordinances that ensure safe transportation of the food. For instance, businesses that transport USDA Grade-A dairy and pasteurized milk may qualify for a waiver. 

What are some key takeaways about the Sanitary Transportation Rule?

A lot of industry members have already implemented many of the best management practices that will be mandated by the proposed rule. Companies will need to focus on documentation and training. Companies will need to develop procedures to communicate requirements across shippers, carriers, and receivers. They will also need to develop training regimens and validation systems to ensure that these requirements are being met. Documentation is critical. In the eyes of a regulator, if it isn’t documented, it didn’t happen.

More information visit www.SafetyChain.com/FSMA-Fridays.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Is that Red Snapper on your Plate Really a Red Snapper?

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

Over the past few years, several consumer and news organizations have researched and tested seafood available in supermarkets and restaurants. The findings:

  • Some 35 percent of seafood samples in the U.S. were found mislabeled; 
  • Of the fish that were most commonly mislabeled, 
  • Red Snapper topped the list (at 86 percent being mislabeled);  
  • Nearly 16 percent of grouper was mislabeled; 
  • In one out of five cases, Atlantic or farmed salmon was substituted for wild or King salmon; and
  • “White tuna” was mislabeled 100 percent of the time. 

A more recent investigation into fish labeling fraud carried out in Europe revealed that 32 percent of seafood in Italy, 30 percent of all hake in Spain and 19 percent of cod in Ireland were mislabeled. Repeated studies have shown that these results are not one-off, but seafood fraud is consistent and not showing signs of any improvement.

E. Pearce Smith, Laboratory manager, GeneScan, at Eurofins talks about the challenges in testing seafood authenticity. There are a couple of issues with regards to seafood fraud, Smith says: “From an economic standpoint, you could be buying a cheaper fish (for instance a breaded tilapia fillet instead of a breaded grouper fillet) for more money. Also, from a quality point of view, you lose out.”

More importantly, Smith adds, from a food safety perspective, if you are unknowingly processing a wild grouper sandwich, you are not considering the right safety, microbiological and decomposition markers for the wild fish. Or if it is a farmed tilapia product, you are not looking at prohibited veterinary drugs in farmed fish.

The horsemeat scandal that rocked large regions of Europe in 2013 was the basis for this focus, Smith says. “With horsemeat being sold as beef, producers were not testing their beef products for bute or phenylbutazone, an anti-inflammatory used by vets mainly to treat pain and fever in horses.”

When testing is an art as well as a science

So far, seafood species authentication depended on tests that were developed many years ago. FDA published a protein method known as isoelectric focusing, in which you take a piece of a tissue, digest it into a slurry and run it out into a gel. By comparing the banding pattern to known references, you can conclude what kind of fish it is. The problem with this technique, Smith says, is that it is often inconclusive, or at least open to interpretation in many cases.

So, about three years ago, FDA decided to abandon this 1950s technology for a more modern technology – DNA barcoding.  So now, instead of using a protein pattern, the test involves isolating the DNA and amplifying a specific section of it for analysis. 

“In a relatively short sequence, of about 700 base pairs, it’s very easy to distinguish one species of fish from another,” Smith says, adding that now food companies want to drive the switch from the protein testing to the DNA method.  Testing for the protein requires a lot more hands-on time and testing one sample can take several hours, Smith explains. “With the DNA method, you can automate the testing to a much higher degree to handle hundreds of sample a day. And with the cost of sequencing dropping, such testing is no longer cost-prohibitive,” he adds.

Robust methodology

The new methodology is robust because DNA is a very stable molecule, according to Smith. “You can test raw or cooked fish with this method, while the protein test was not as good at spanning the pre- to post-processed product. You can also test a finished product such as a frozen fish dinner.”

What are the limitations? Smith lists a few examples: Testing a food product that could have multiple types of fish, such as a fish cake or Surimi, which are ground up into a paste, and could have multiple seafood products in them. Canned tuna is not suitable for testing, because the high pressure process involved is very destructive and you may not be able to get a nice clean read of the DNA. FDA has identified about 150 unique species as targets for substitution, or of high commercial value at risk of being substituted for monetary gains.

“The samples that we get from food producers usually turn out to be what we expect them to be, but sometimes, they don’t. When we get samples from consumer groups, about 30 percent are mislabeled. Also, variations in regional names for that particular fish also contribute to confusion and mislabeling,” Smith explains.

FDA is now publishing the reference sequences for the different species of fish to make identification quicker and easier. Earlier people had to rely on private databases and some of these, while good, weren’t easily accessible. 

Smith sees a lot of demand for testing species such as salmon (differentiating pink salmon Oncorhynchus gorbuscha, Chinook salmon Oncorhynchus tshawytscha, or Coho salmon Oncorhynchus kisutch); and red snapper (which faces high demand but is low in supply, and is commonly substituted with other fish of the same size or color). He says that the importance for this testing is growing increasingly as companies are importing seafood product, and it is critical that the species be correctly identified on the packaging. Imports are the source of as much as 90 percent of the fish consumed in the U.S., and only about 2 percent of those products are inspected, he adds. 

Food Defense Rule – What You Need to Know

By Food Safety Tech Staff
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What is the Food Defense rule and how is it different from the Preventive Controls rule proposed under FSMA?

On December 24, 2013, the U.S. Food and Drug Administration proposed the Rule for Focused Mitigation Strategies to Protect Food against Intentional Adulteration under the Food Safety Modernization Act. 

Also known as the food defense rule, the proposed rule would require domestic and foreign facilities to address vulnerable processes in their operations to prevent acts on the food supply intended to cause large-scale public harm, and would require the largest food businesses to have a written food defense plan that addresses significant vulnerabilities in a food operation. Comments are due by end of the month.

In a recent FSMA Fridays webinar, sponsored by SafetyChain Software, Dr. David Acheson, and Melanie Neumann of The Acheson Group discussed this rule. We present some excerpts below). 

Who does the Food Defense rule apply to?

The goal of this rule is to put preventive controls in place where terrorism is a threat. By making this rule risk-based, FDA aims to prevent a single-point attack with potential mass casualties. This rule is focused on large manufacturers and processors of human food with sales of over $10 million. It will not affect small manufacturers or farmers with the exception of dairy operations and bulk liquids. 

If the rule applies to you, what do you need to do?

Assemble a food defense team with industry experts and come up with a food defense plan. Conduct vulnerability assessments. Think about the possible agents and the processes whereby that agent could be added to one of your foods. What are your actionable process steps and mitigation strategies? For instance, how can you control access to bulk liquids and bulk mixing? The food defense plan does not need to be validated, but it does call for training, monitoring, and documentation. 

What are the similarities and differences between Preventive Controls and Food Defense rules?

Unlike Preventive Controls rules, there is no need to validate that the Food Defense mitigation strategies are effective. Also, if you’re doing your own vulnerability assessment, you need to have someone who knows what they’re doing, but they don’t need to be a ‘qualified individual’ as required under the Preventive Controls rule. Another distinction is that with Food Defense, there’s no assumption that the food you produce is automatically adulterated if there are problems with your mitigation strategy.

How will I know if my Food Defense approach is effective?

It is impossible to know if a food defense strategy is effective without challenging the system. It is highly unlikely that FDA will simulate an attack to gauge Food Defense effectiveness. Even though the likelihood of a terrorist attack on the food supply is rare, the industry must go through due diligence to try to prevent attacks from happening. It is not enough to have a security camera in place if that camera doesn’t work or if no one is monitoring it. 

 

This rule will not be finalized until Spring of 2016. FDA wants comments from industry on Food Defense and on how it can be shaped into a practical and economically feasible program. 

Where does economically motivated adulteration fit into this?

FDA is covering economically motivated adulteration with the Preventative Controls rule, not Food Defense. There has been a lot of controversy regarding this decision. Where does precedent lead to a reasonably likely event to control? If the scope is not limited, this could require an excessive amount of testing for many different compounds in incoming ingredients with significant economic impact. 

More information visit www.SafetyChain.com/FSMA-Fridays. 

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!”

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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.