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. 

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

How a Global Snack Powerhouse Follows Supply Chain Best Practices

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

Mondelez-International-Brands-March2014
Known for its global brands such as Oreo, Ritz, Cadbury, Toblerone, Trident and Tang, Mondelēz International is a global snacks powerhouse, with products marketed in 165 countries. 

The company, which was created in October 2012 with spin-off of Kraft Foods Group, earned net revenues of $35 billion in 2012, and is the No. 1 in biscuits, chocolate, candy and powdered beverages; and No. 2 in gum and coffee. Mondelēz also employs approximately 110,000 people and works with nearly 3000 raw material suppliers. 

Against this background, the primary goal for the company is to provide Food that is Safe to Eat, described Peter Begg, Sr. Director, Global Quality Programs, Mondelēz International. 

Talking about Global Supply Chain Best practices at the recent Global Food Safety Conference, Begg described that his company ensures that its consumers and customers can trust the products that they manufacture and provide by: 

  1. “Having a comprehensive Food Safety program that meets or exceeds regulatory requirements and ensures global consistency; 
  2. Benchmarking annually to ensure the robustness of our food safety program including 3rd party audits (GFSI);  
  3. Continuously evolving our global strategies on Food Safety, with goals to drive further progress; and 
  4. Leveraging Supply Chain initiatives to support the Food Safety program.” 

At Mondelēz, food safety management occurs at multiple levels, said Begg: “The International Board of Directors Level reviews food safety management; the Executive Team level assesses company risk profile and management programs; food safety and quality senior management establishes food safety policy, control programs, and compliance mechanisms; business units implement company food safety policies and programs, and ensure regulatory compliance; and the Special Situations management team assesses and proactively manages issues, issues prevention, and communication of lessons learned.” 

Begg stressed that “companies need to make food safety culture personal, so people don’t bypass it. Mondelēz has had 0 incidents, 0 defects and 0 losses – and this will not be possible without 100 percent employee involvement.” 

He described an Integrated Quality Management Approach that focuses on systems across key factors in the supply chain: “Risk categories (covering chemical, microbiology and physical risks) are addressed along several steps (Design, Procure, Covert, Distribute, Trade and Consumer) using various quality risk prevention programs such as design safety analysis; HACCP; allergen management; supplier QA; material monitoring; continuous improvement; traceability, complaint management, process capability/ Six Sigma; warehouse controls and labeling.” 

Begg described Mondelēz’ quality and food safety programs that help assess, manage, and mitigate risk: 

Risk Assessment:

  • Supplier approval and management: determines suppliers risk profile and ability to meet MDLZ standards before use and on an ongoing basis;
  • Design Safety Analysis: new/changed product concepts are evaluated to design out potential physical hazards;
  • Hazard Analysis & Critical Control Points (HACCP) – focused on prevention, identifies conversion risks, controls, and monitoring compliance; and
  • Third Party Validation – validation of key systems; Design, HACCP, Micro, Allergen, Supplier, Auditing. 

Risk Management:

  • Auditing – risk based approach to assesses compliance to policy and execution of programs leading to corrective/ preventive actions;
  • Material Monitoring – incoming material testing program to verify the effectiveness of preventative programs;
  • Training – drives awareness of policies, programs, roles & responsibilities and enhances organizational competency;
  • Traceability – programs to manage and trace materials thru finished goods; 
  • Spec Management – specification development and change management process for materials, processes, and finished goods; and
  • Contingency Planning for single/ sole source and regionally isolated ingredients. 

Risk Mitigation:

  • Special Situations Management – defined company-wide process for proactive and effective management of issues minimizing potential impact to the business. 

Mondelēz has made a strong commitment to the Global Food Safety Initiative. According to Begg, the company has asked its nearly 3000 raw material suppliers globally to get certified under a GFSI benchmarked standard by 2015. All internal manufacturing facilities will have a GFSI certification (FSSC 22000) by the end of 2015 as well (currently 80 percent of facilities are certified). The company is also promoting GFSI to its external partners including joint ventures and external manufacturers.

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.