Tag Archives: FSMA

Why GFSI? And How Can It Help?

By Jennifer Brusco
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The Global Food Safety Initiative or GFSI, simply explained, is a business-to-business Food Safety and Modernization Act (FSMA). It operates quietly and privately within the marketplace between the customers and their suppliers. It operates on not only a global basis, but also on a regional and local basis.

“Although people look at the [GFSI] program and see a lot of multinational corporate logos, frankly the majority of our operations are small and medium size facilities at the local level. So we welcome facilities of all natures – large, medium, and small, across the food to fork continuum,” Karil Kochenderfer, North American representative, GFSI, said during a recent webinar.

GFSI has approximately 25 benchmarked guidances, with some of the latest scope expansions include:

  • Packaging and animal conversion – August 2011;
  • Animal feed – June 2012;
  • Storage and distribution – October 2013;
  • Food brokerage/agents, retail/wholesale – early 2014; and
  • Catering, equipment manufacturing, food safety services – 2015.

Where are these guidances coming from? How can you be sure that these guidelines are science-based, risk-based, and address the issues in your plant/facility?

Why-GFSI-June2014At the very base of our efforts that are ensconced within these guidance on a sector by sector basis, are the international standards of science based within the Codex Standard on Food Hygiene. On top of that are Hazard Analysis and Critical Control Points or HACCP standards. Above HACCP are National Regulations, which includes FSMA in the U.S. and the Safe Food for Canadians Act in Canada. In Europe it’s something different, in Japan it’s something different, but all have iterative levels of science-based regulation in place to ensure the safest control of the food and management of the food. Above National Regulation is GFSI Certification.

“We go above and beyond the science of Codex, HACCP, and national regulation to perform at the highest level of industry. And our benchmarked schemes [eg. BRC Global Standards (BRC), Food Safety System Certification (FSSC 22000), International Featured Standards (IFS)] go beyond us and corporate programs go even further,” Kochenderfer highlighted.So what you have are several layers of protection that will help protect both consumers and companies.

What are some of the shared benefits for industry?

There are several benefits, which include:

  • Meet the requirements for one, meet the requirements for all;
  • Reduce duplication of audits;
  • Have comparable audit approach and outcomes;
  • Ensure the continuous improvement and customer opportunity for those GFSI-benchmarked companies;
  • Enhance trade opportunities;
  • Improve customer confidence in food safety; and
  • Gain cost efficiencies throughout the supply chain.

“We have now built confidence in third-party certification because we have reduced inefficiency in the food system. Now, it’s ‘Once Certified, Accepted Everywhere,'” stated Kochenderfer.

John Kukoly, Director of BRC in the Americas, added that companies should pursue GFSI certification for a number of reasons:

  • Customer mandate;
  • FSMA;
  • Nearly a 40 percent reduction in product non-conformance;
  • Competitiveness; and
  • Superiority in the market.

Right now, only a third of the industry has achieved GFSI certification, which leaves the remaining two-thirds either still at the starting line or just a few steps into their journey. How do you choose a GFSI-recognized scheme and get started?

Karil Kochenderfer shared a chart to allow users to see where they fall on the farm-to-fork continuum and further determine which scheme(s) would work for them.

Further, we have developed four GFSI checklists for the four major schemes that apply to food manufacturers, co-produced with the respective scheme owners to ensure accuracy and usability. The checklists are complimentary and may serve as a great resource on your journey toward GFSI certification.

Additional Resources:

FDA Access to Records Under FSMA

By Michael Biros
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What are the latest updates with FSMA and how has FDA’s access to records changed? Dr. David Acheson of The Acheson Group gives us the latest.

When it comes to latest updates regarding FSMA, the comment period on the proposed sanitary transportation rule has been extended to July 30, 2014.

What does FSMA change in terms of FDA access to records?

Before FSMA, FDA needed reasonable proof that a food would be adulterated and a threat of serious adverse health consequences or death to humans or animals (SAHCODHA) in order to access records.

Now, FDA needs reasonable probability that the use or exposure to a food, or any other articles of food that FDA believes is likely to be affected in a similar manner, would cause serious adverse health consequences. What FDA considers to be a reasonable probability will be determined on a case-by-case basis. These changes significantly expand the scope of what FDA can look at and lowers the threshold for records access.

Does FDA need to issue a formal request?

Formerly, FDA needed to invoke the Bioterrorism Act in order to gain access to records. This was a cumbersome process that required strict criteria to be met.

Currently under FSMA, FDA must provide written notice of what they are asking for. This documentation will be delivered by a credentialed FDA official.

Generally, access to records must be given as quickly as possible within 24 hours of the request. The records do not need to be in any particular format. Electronic records are still considered on-site records so long as they can be accessed from within the facility.

What can FDA ask for?

FDA has produced guidance documents that lists what they can ask for. FDA can request access to manufacturing records, ingredients receipt records, product distribution records, product inventory records, test records, recall records, reportable food records, customer distribution lists, and complaint/adverse event records.

There are some exceptions. FDA cannot request personnel records, financial records, recipes, some records from farms, and some records from restaurants.

How will FDA maintain the confidentiality of any protected information in records it obtains?

While some of these records may be accessible through the Freedom of Information Act (FOIA), FDA is responsible to protect and redact commercial confidential information in accordance with their own requirements. However, some of this sensitive information can be shared with other federal, state, local, and foreign authorities.

For more information, click here to see archived FSMA Fridays webinars, organized by SafetyChain Software. 

FSMA: What’s the Latest, and What Do You Need to Know

By Michael Biros
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Is your company ready for ‘TACCP?’ Do you know how long you will be required to retain your records? Is your carrier up-to-date on the sanitary transportation section of FSMA? Dr. Bob Strong, Senior Food Safety Consultant at SAI Global, gives an overview of the newest updates on FSMA.

Questions were raised recently by brewers and distillers about spent grains being sold as animal feed. FDA recognizes that hazards will be minimal, but charges facilities with protecting spent grains during storage awaiting collection and during transportation as required under FSMA Section 103. This will require protection against physical and chemical contamination and references the inadvertent addition of industrial waste oil to used fryer oil that exposed 100,000 chickens to PCBs. The comment period for this is closed and the final rule is expected to be published this summer. The final rule is scheduled to take effect by August 30, 2015.

Record retention and availability applies to anybody who processes, packs, transports, distributes, receives, holds, and imports human or animal food. However, farms, restaurants, USDA plants, personal consumption, non-food packaging, and food contact packaging manufacturers (but not users of this packaging material) are exempt from this requirement.

The length of record retention depends on the perishability of the food product. If the shelf life is less than 60 days, both the handler and transporter must retain records for 6 months. If the shelf life is between 60 days and 6 months or if the food is animal/pet food, both the handler and transporter must retain records for 12 months. If the shelf life is greater than 6 months, the handler must retain records for 2 years, but the transporter must retain records for only 12 months. Records must be available within 24 hours of a request by FDA and civil action may be taken if records are not kept or made available. This final rule was published on April 4, 2014.

FSMA section updates

These updates are confined to Section 106 — Intentional Adulteration of Foods; Section 111 — Sanitary Transportation of Human and Animal Food; and Section 204 — Designation of High Risk Foods Relative to Record-keeping for Traceability.

To recap, FSMA does not apply to facilities regulated by USDA (meat, poultry, and eggs). Also exempted are juice manufacturers, seafood processors, alcohol-related facilities, low-acid canning (except to expand their hazard analysis), and small businesses.

FDA is considering modified requirements for warehouses and having Preventative Controls only if they are storing refrigerated products.

Section 106 — Intentional Adulteration of Foods

The intent of the proposed rule is for companies to begin using a “qualified individual” to develop a written food defense plan. This plan will protect against intentional adulteration of food for the purpose of causing harm to consumers. The plan should focus on actionable process steps, mitigation strategies, monitoring, corrective actions, and verification.

The regulation exempts very small businesses, companies with a majority of sales to very small businesses, storage facilities (except for bulk liquid storage), alcoholic beverage manufacturers, and animal feed manufacturers and distributors.

Actionable areas and mitigation strategies:

Key actionable areas identified by FDA include: bulk liquid receiving and loading, bulk liquid storage and handling, secondary ingredient handling, and mixing and similar activities. Deliberate acts of contamination may come from acts of terrorism; disgruntled employees, consumers, or competitors; or economically motivated adulteration such as the melamine tainted milk incident.

Companies must identify and implement mitigation strategies, establish procedures to monitor these strategies, implement corrective actions, verify that monitoring is being conducted, train supervisors assigned to actionable process steps, and maintain records.

Examples of mitigation strategies include restricting access to potential adulteration points such as loading and receiving areas, bulk liquids, secondary ingredient handling rooms, and open processing points. Facilities must require tankers to be sealed after loading and the seals must be checked at receiving.

TACCP

FDA is asking for comments on using HACCP principles to develop food defense plans. They are considering calling a control point a TACCP (Threat Assessment Critical Control Point). They are also trying to identify the risk of adulteration to specific processes. Some examples of low risk foods that are hard to adulterate are: shell eggs, whole produce, game meats (not ground), peanuts/tree nuts, and sugar cane/beets. FDA has extended the comment period through June 30, 2014. 

Section 111 — Sanitary Transportation of Human and Animal Food 

This section builds upon the previously issued Sanitary Food Transportation Act of 2005. It has five major sections: vehicle and transportation equipment, transportation operations, information exchange, training, and records.

The regulation exempts shippers, receivers, and carriers that have less than $500k in total annual sales; the transportation of raw agricultural commodities by farm vehicles; food being shipped through the US to another country; food imported to be exported, but not consumed in the US; shelf stable foods that are completely enclosed in a container; the transportation of compressed gases; and the transportation of live animals.

Vehicles and transportation equipment

The proposed rule will establish requirements for the design and maintenance of vehicles and equipment to ensure that they do not cause contamination of the food being transported. This includes bulk and non-bulk containers, bins, totes, pallets, pumps, fittings, hoses, gaskets, and loading/unloading systems.

The regulation identifies the potential for cross-contamination from: incorrect use of packing materials (reusing wood containers for produce that once held raw meat); using the same hoses or pumps with different allergens or raw and ready-to-eat products; and pallets in poor condition (splintering or projecting nails).

The proposed rule will establish requirements for cleaning, inspection, maintenance, loading/unloading, and operation of transportation equipment to ensure no contamination or temperature abuse of the products during transport. This includes the growth of spoilage bacteria as well as pathogenic bacteria. This will be achieved by ensuring adequate temperature controls, separation of foods with different temperature requirements, and the cleanliness and physical condition of trailers, tankers, pallets, etc.

Communication

Carriers, shippers, and receivers will be required to exchange information regarding prior cargos, the cleaning of bulk transportation equipment, and temperature controls. A log of prior loads must be kept. FDA will not restrict what can be hauled. Rather, they will regulate the cleaning between loads. Wash tickets must be kept and shared with customers. Washing may include sanitizing where necessary.

The carrier must communicate with the shipper and receiver that temperature sensitive foods were transported under the required temperature conditions. This requirement can be waived for short hauls or if the shipper loads a temperature recording device with the shipped products. The shipper and receiver are required to specify in writing the temperature requirements to the carrier. The receiver must confirm compliance.

Training, records and waivers

Carrier personnel must complete training in sanitary transportation practices and must have documentation of this training. This will include personal hygiene for drivers and loading/ unloading workers, training in security, accessibility to hand washing, and avoiding cross contamination in handling mixed loads. Procedures, training, cleaning, prior cargos, and temperature control must be recorded and properly maintained.

Shippers, carriers, and receivers who hold valid permits and are inspected under the National Conference on Interstate Milk Shipments (NCIMS) Grade “A” Milk Safety Program may be waived from these requirements only when they are involved in shipping Grade A milk and milk products. Transportation of food relinquished to consumers may also be waived (such as the pizza delivery guy).

Section 204 — Designating High Risk Foods for the purpose of record keeping related to Traceability

This proposed rule designates high-risk foods based on known food safety risks. The criteria for modeling and scoring risk are:

  1. Frequency of Outbreaks and Occurrence of Illnesses: This must include chemical and microbiological food safety hazards. Chemical hazards include allergens, mycotoxins, pesticides, and heavy metals.
  2. Severity of Illness: This will take into account illness duration, hospitalization, and mortality.
  3. Likelihood of Contamination: This is based on number of recalls and contamination that has been known to occur.
  4. Pathogenic Growth Potential/Shelf Life: Strong growth potential is likely at temperature at which the food is intended to be held and stored, including refrigeration and room temperature. This will be coupled with shelf life where longer shelf life can increase risk.
  5. Manufacturing Process Contamination Probability/Intervention: High probability has recurring or frequent detection of contamination. Low probability has infrequent detection of contamination or where contamination is introduced post manufacturing. This will be coupled with the availability and implementation of control measures.
  6. Consumption: This is the percent of the population that consumes the food.
  7. Economic impact: Lower is defined as $100-500k impact per year and higher is greater than $10m per year.

What Constitutes a Successful FDA Audit?

By Sangita Viswanathan
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From the proposed third party accreditation rule, to GFSI audits, and needing more trained and experienced auditors, the process of auditing food facilities is undergoing a sea-change. What is the impact going to be on food companies, auditors, and the auditing process?

In a recent FSMA Fridays webinar, sponsored by SafetyChain Software, an expert team from The Acheson Group, comprised of Melanie Neumann, J.D., M.S., VP and Chief Financial Officer; Jennifer McEntire, Ph.D., VP and Chief Scientific Officer; Anne Sherod, M.S., Director of Food Safety and Valerie Scheidt, MBA, CP-FS, Director of Food Safety, answered key questions on conducting successful FDA audits. We present some excerpts below.  

How does the FSMA third party audit accreditation rule impact the audit process?

 

The purpose of the third party accreditation and certification audit is to issue a certificate for high risk foods or the voluntary qualified importer program. The main foundation of the standards that FDA is setting will come from the human preventative controls rule, the animal preventative controls rule, and the produce safety rule. Some standards may also come from the sanitary transportation rule and food defense rule. FDA will be appointing an accreditation body and this accreditation body will approve and monitor certifying bodies (CB). These CBs can be private companies or private individuals who will be authorized by the accreditation body to perform the audits and issue those certifications. 

 
Foreign governments can also be approved by FDA to act as a CB. Right now only New Zealand is approved and FDA is looking at approving Canada. We don’t anticipate any other country to be approved in the near future.;

Certifying bodies will have strict conflict of interest and reporting requirements to FDA. CBs must report to FDA within 45 days even if they’re just performing a consultative audit. They must also report to FDA if they see an issue that could lead to a Class I or Class II recall and they have to report to FDA before they report to the company that they are auditing.

 

Will a GFSI audit satisfy FSMA audit requirements?

GFSI audit requirements do not match the FSMA audit requirements, but they are not too different. Several of the schemes are very similar, and each scheme owner is making a concerted effort to become FSMA compliant. If an auditor is doing a GFSI audit, they do not need report to FDA before the company. The FSMA requirements of avoiding conflicts of interest, record keeping, and training may deter GFSI auditors from becoming Certifying bodies under FSMA. Unless FDA offers an incentive, there will be a shortage of FSMA CB auditors. 

 

What are the elements of a successful audit?

The number one goal of an audit is to identify risk. The audit needs to accurately describe the non-conformances against the audit standard to give your quality and operations team reliable and actionable data so they can mitigate that risk. The relationship between the auditor and the facility should be a partnership, add value, and build trust. The facility should learn from the auditor and the auditor should understand what the facility is doing to mitigate risk and promote food safety. Continuous improvement takes the feedback from the non-conformances and evaluates them against the organization’s goal around risk. Whether the results are from an announced, unannounced, internal, second, or third-party audit, continuous improvement is critical, and this requires commitment from management and will help the facility become audit ready. 

 

How can I ensure my auditor is up to the task?

Most audits use checklists. This goes for both the auditor and the audited. The checklist provides a standardized list of what’s expected and adds an element of order and control to the audit. It also allows for an effective way to quantify metrics. 

However, using a checklist alone can lead to minimum risk finding. The auditor needs to find a balance between being strategic and prescriptive. In order to be effective, audit protocols need to be periodically reviewed and updated. This is especially relevant with FSMA and holds true for internal and third-party audits. Check to see if the auditor’s checklist is pre-FSMA or post-FSMA. Ask the auditor when was the last time that they reviewed and updated their audit protocols. 

 

Will we have enough good auditors to meet the need?

No, we already don’t have enough good auditors. The implications of this are that we may get substandard audits from substandard auditors. The current model isn’t working and we need a new approach. Currently, most auditors have extensive prior experience working in industry and often become auditors after they retire.

We are creating auditors not through structured training. This model is not sustainable and has limited growth potential. It will not provide the level of training required for GFSI or FDA third party certification requirement. We need a training program for auditors who come right out of school. We need people to go to school for food safety and be able to become an auditor after graduation. Food safety needs to be incentivized at the university level. There should be a bachelors degree in food safety auditing. We need structured training and developmental opportunities for folks earlier in their career rather creating auditors at the end of their career.

Training in the Food Safety Industry

By Sangita Viswanathan
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Dr. John Surak food safety trainer and Warren Hojnaki of SGS talk about trends they see in food safety training, areas of focus, how to keep training relevant and useful, and what they are expecting to see in the future.

FDA, FSMA, FSMS, HACCP, GFSI, BRC, SQF, IFS, FSSC… The food safety sector is a cornucopia of new regulations, abbreviations and standards. Helping navigate this maze are food safety training courses and the instructors. However, the success of training programs depends on how applicable these courses and the curriculum are to the industry and the specific client, and how experienced and knowledgeable the instructor is in understanding current regulations, specifications of standards, hazard profiles and compliance requirements of that client. 

In an interview with FoodSafetyTech.com, Dr. John Surak, food safety trainer, and Warren Hojnaki of SGS, talk about trends they see in food safety training, areas of focus, how to keep training relevant and useful, and what they are expecting to see in the future.

John Surak, Ph.D., is principal of Surak and Associates, a full service food safety and quality consulting service. He works with the food processing industry in developing food safety and quality management systems, designing and implementing process control systems, and implementing Six Sigma and business analytics systems. Warren Hojnacki is Training Manager, for SGS North America. His department delivers training services for North American clients. 

FoodSafetyTech.com: What are some broad trends in food safety training that you are noticing?
Hojnacki: What we are seeing is a lot of clients needing foundational training. For instance, our most popular training programs are still HACCP, implementation for FSSC 22000, SQF etc. On the other side, clients are still very confused about what they should do regarding new and proposed food safety regulations. While they are following the directives that they receive from their customers, currently there still is a wait-and-see mentality. 

Dr. Surak: I notice the focus on food safety moving up the food chain. About 5 to 7 years ago, our primary clients for food safety training programs were food processing companies. Now our clients are suppliers to these companies as food companies are pushing the requirement for training on them. These supplier companies then need to make decisions on what schemes they want to be certified under. Most of the time, the customer accepts any GFSI-recognized scheme, but sometimes the customer names a specific scheme. Different GFSI schemes have different sweet spots and advantages. They all assume different knowledge about food safety and some are more prescriptive than the others. Clients have to figure out which scheme would be the best fit for them. 

FST: What kind of training courses are most popular, most asked for?
Hojnacki: When clients and companies decide on getting audited or certified against a particular food safety standard, training for that standard is a common requirement. Auditors specifically want to be trained to build their skill level, whether it’s getting trained for HACCP or FSSC 22000. A number of our clients also come to us saying that when they have a 3rd party audit, the most common non-conformances pertain to a less than robust internal audit system, so auditor training is a critical area that our clients ask for. 

Dr Surak: One of the biggest aspects of training that I try to focus on is lead auditor training. This course is designed to help an individual get certified in a particular audit scheme. We cover the same information for internal auditor training. However, the difference in this case is that for the internal auditor, the goal is to get his company certified. If a company has a strong internal auditor, they can reap substantial benefits. We also focus on, as part of our training, doing mock audits. This is more than going into a course or workshop and giving a lecture. For mock audits, you are put into a spot where you have to make real decisions on the floor. When we conduct such practice audits with our clients, in addition to our regular food safety training courses, we find a high level of involvement and interaction from the attendees and appreciation from the client. 

FST: What are some of the gaps in the training that you notice?
Hojnacki: What we see in general is people not covering the topic in-depth enough. Many training courses (outside those offered by SGS) seem to cover the topic in a very superficial manner and this doesn’t help. 

Dr. Surak: Many of the attendees who come to an audit training class have never taken the time to familiarize themselves with the standard. So what you are doing in that time is teaching them the standard and then teaching them how to audit. If the participants already know the standard, then you focus on just reviewing the standard and cover how to go about doing the audit. 

FST: What are some common questions attendees ask at ‘implementation/auditor’ training?
Hojnacki: Attendees very much want to know application to their respective situation. As an auditor, you need to know the right open-ended questions to ask when you are conducting an internal audit, and in our training, we provide examples for that. 

Dr. Surak: Our training focuses on enabling auditors to get the participant in a conversation and be able to answer questions during an audit. We are not in the business of writing traffic tickets, we are out to assess if the food safety system meets the standard, and also to identify the areas where it needs to be strengthened. Things that participants typically want to know are, going into a 3rd party audit, what is the auditor going to do? How is he going to react? And how can they present themselves in the best possible way to have a good audit? Also the instructor or auditor needs to understand the differences in the standards and the different hazards. There are unique challenges for different suppliers – or where along the supply chain they are, for instance are they a retailer, a supplier or a processor. It’s not a one size fits all situation. If you are looking at ingredient suppliers, the hazards are very different than what a retailer would be looking at, for instance. 

FST: How do you identify the best training company or program for you?
Hojnacki: We go through this everyday with every client call and we understand that we are not the only resource, our clients have several options. We first evaluate the trainer to understand what’s their educational and work experience background? Does it correlate to the industry you are in? Are they practitioners or just theorists? Food industry is a very big growth area right now, and we are seeing a proliferation of tutors coming into this field. Some of them have varied backgrounds, such as in automobile or aerospace industry. Often times, clients will make a decision based on prices quoted, and then realize that it didn’t work out the way they had anticipated. We (SGS) have often had to go to that client and redo things. Today, more than ever, the decision to choose a trainer/ training vendor, needs to be based on their competence, experience, and skills. 

Dr. Surak: I was recently at a client where they had completed certification training. When I asked to see the materials and bios of the instructor, I noticed that he had no prior experience in the food industry. I wondered how you could teach internal auditing in a food processing industry if you did not know about food processing! It’s imperative that clients look at the trainer’s background and experience. 

FST: Food safety training in 2015 – what will change?
Hojnacki: Food safety training curriculum will have to increasingly show greater applicability to clients to meet their needs. It has to be a round peg and in a round hole type of situation. Especially with FSMA rules getting finalized, clients are going to expect more out of their training. They are going to expect their instructors to be a resource, and to be up to date on the respective regulations and be able to tell clients how these rules will apply to them, and what they need to do differently. 

Dr. Surak: Processors are going to ask questions such as ‘I am certified to a GFSI scheme, so now do I have to do anything additional to meet new requirements’ or ‘are there areas where we have done some basic groundwork, and we have to raise the bar higher because of new regulations,’ and trainers need to be able to answer these.

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.

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. 

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EQMS and HACCP – Friends or Foes?

By Kelly Kuchinski
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How quality processes can allow companies to take a more preventative approach to product recalls.

HAACP4 300x281 EQMS and HACCP Friends or Foes?I recently spoke to a friend who was a plant manager at a food manufacturing company, and he is all too familiar with today’s manufacturing challenges and product quality issues. We discussed how quality processes allow companies to take a more preventative approach to product recalls. He agreed that if quality and regulatory requirements are met before a product leaves the facility, organizations can be sure that they are providing safe product to their customers. The ability to identify issues before a product is distributed can also reduce additional costs associated with product recalls and the impact on a brand’s reputation and sales.

We then discussed how important HACCP was to his team. Hazard Analysis and Critical Control Points (HACCP) is a process control system that identifies where hazards might occur during the food production process and puts actions into place to prevent such hazards from occurring. By monitoring and controlling each step of the process, there is less chance for contamination or other hazards to occur.

He shared a story on his first experience implementing a HACCP plan at his previous facility. He noticed key areas where sanitation standards were not being met so he identified necessary corrective actions required to keep finished product safe. The process of monitoring these changes was difficult to manage and was draining the already limited resources in the plant.

During a team meeting, he brought up the issue and the QA Director mentioned that they were using a quality management system that managed workflow processes. They discussed how CAPA and complaint management were key processes that they were using in the QA area and it would easily support corrective actions associated with HACCP.

Within a few days, they were able to setup the system to support his team and automate the process. The most notable difference in using the QMS software was the time savings and reduction in recording errors. The system provided an interface that was easy to use and provided drop down menus for easier navigation through the system, unlike the cryptograms needed to use their ERP system.

As we finished up our call, we agreed that the true benefit of a quality system is visibility. We can now monitor potential hazards in the facility, manage outside supplier and third party manufacturers, and track compliance with regulatory requirements across the enterprise using one centralized system.  It is this visibility across the organization and its supplier network that allows organizations to tie in multiple quality controls, regulatory requirements and HACCP processes to automate and maintain the record of any change and preventative action to ensure consistency and safety of all finished products.

With companies encountering spikes in unforecasted demand, new levels of regulatory scrutiny, and fewer resources than ever before, my friend and I agreed that EQMS systems are more crucial than ever to help manage the complexities of quality process and allow issues to be resolved when they are identified early on.

About the Blogger:

Kelly Kuchinski, Industry Solutions Director at Sparta Systems, has 20 years of product management and marketing experience with a focus on consumer packaged goods, chemicals, life sciences and technology. Prior to joining Sparta Systems, Kelly focused on developing products and solutions to support companies across multiple industries to enhance functionality, increase efficiencies and reduce costs. She held product management and marketing positions at Merck Chemical, GS1, Checkpoint Systems and GE Capital. Kelly has an MBA from LaSalle University and received her Six Sigma Green Belt certification while at GE Capital.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

To Test Or Not To Test?

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

In recent years, the federal government has become increasingly aggressive in its investigation of foodborne illness outbreaks, its inspections of food processing facilities, and its food safety enforcement activities. Notably, the federal government’s recent full-court, food safety press has been driven, in large part, by the increased visibility and awareness of food safety in the media and among consumers.

As FDA has been given additional food safety authority in recent years, the USDA has stepped up its game as well. Not wanting to be left behind, perhaps, USDA has begun focusing more aggressively on possible connections between slaughter establishments and outbreaks or positive regulatory ground beef samples. Under the Systems Tracking E. coli O157:H7 – Positive Suppliers (STEPS) framework, for instance, USDA will often take action against slaughter establishments that repeatedly appear in the STEPS system. This can take many forms, ranging from intensified environmental pathogen sampling to a Food Safety Assessment (FSA) for cause.

If USDA decides to conduct environmental pathogen sampling to “test” a company’s preventative controls or its compliance with the regulations, that company is always welcome to take its own “companion” or “sister” samples. With that said, I do not believe there is any benefit to actually doing it.

If an USDA environmental sample tests positive, the agency will not care whether a companion sample tests negative. Contamination is not always distributed evenly, and testing sensitivities will often vary. Thus, FSIS will in all instances treat its own result as a “positive finding.”

The same general rules apply with respect to environmental sampling, whether being conducted by USDA or FDA, for other pathogens like Salmonella or Listeria. In the event of a positive, the government will likely not care about a negative companion sample collected by the company, and will rely on its own results. Moreover, what happens if the agency sample tests negative, and the companion sample collected by the company tests positive? I have seen it happen many times.

Thus, here too, I do not see any compelling benefit, nor do I counsel my clients, to always collect companion samples. Moreover, if they elect not to do so, it also avoids the complexities of determining whether to hold, test or even destroy companion samples in the event a governmental sample ultimately tests negative.

With that said, if a company thinks that it may someday want to take companion samples when USDA or FDA performs its own environmental testing, I would strongly urge that the company adopt a written policy governing the specific circumstances under which such samples will be taken. This, of course, would apply to both FSIS environmental and finished product sampling.

Such a policy should clearly define the limited circumstances under which companion samples will be collected, and state that those samples will ONLY be tested in the event of a FDA or USDA positive. In this regard, the policy should articulate that the company will rely upon the governmental findings (and it really has no choice), while at the same time setting forth the justification for performing companion testing (i.e., in the event of a finished product regulatory positive to assist in the determination of the ultimate source). The policy should also make clear, however, that if the FDA or USDA sample tests negative, the companion sample will be discarded within a set period of time (i.e., 24 hours).

If a company adopts such a policy, and then closely follows that policy, it should be able to avoid any second-guessing from the agency (or a trial lawyer in a future lawsuit) if a subsequent issue arises or a recall later occurs. Moreover, assuming the policy provides the underlying justification for the protocol to be followed (which it should), I also think any moral obligation to test a companion sample in the event of an agency negative simply falls away.

Increasingly, companies will find themselves in circumstances where the federal government is demanding to take environmental or finished product samples. Think twice, in those circumstances, about whether a “companion” sample is really your friend.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Food Safety Labeling – Putting Rare Steak On The Chopping Block

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

Like most people, I enjoy a good steak.  

I have also found that, in recent years, my options for good, quality steaks have increased significantly, as food processors and restaurant chains look for ways to distinguish themselves and their products. Industry has moved toward more value-added products, such as mechanically tenderized steaks, using needles to soften the meat and even to inject marinade. Indeed, I think it would be safe to say that the vast majority of steaks now consumed in restaurants are mechanically tenderized.

The use of such technologies, however, creates additional food safety challenges not present in non-tenderized products. This is because, to the extent there is any possible pathogenic contamination present on the exterior of a steak, the process of mechanical tenderization can push that contamination deep into the product, where it becomes more difficult to destroy through cooking.

With that backdrop, the U.S. Department of Agriculture is now becoming more involved in helping educate end-users on the risks associated with mechanically tenderized products. In particular, USDA has published new proposed rules requiring meat processors to properly label any mechanically tenderized meat products they sell. These new rules will likely have two effects: (1) they may make mechanically-tenderized rare or medium rare steaks nearly impossible to sell; and (2) they may drive the vast majority of these products out of the food service market.  

Here’s why. In addition to requiring processors to label these products as “mechanically tenderized,” USDA will also require processors to include validated cooking instructions which, if followed, will ensure that any harmful pathogens in these products are destroyed. The question, then, for industry will be whether cooking mechanically tenderized steaks to the higher temperatures needed to kill foodborne pathogens will prevent them in most cases from being served “rare” or even “medium rare.”  

To justify its new rules, USDA has cited a number of recent outbreaks caused by mechanically tenderized steaks. According to USDA, since the year 2000, there have been a total of six E. coli O157:H7 foodborne illness outbreaks attributable to mechanically tenderized steaks served in restaurants and consumer homes. These six outbreaks, spanning 13 years, have included a total of 176 confirmed E. coli O157:H7 cases that resulted in 32 hospitalizations and 4 cases of HUS (acute renal failure).  

While you can decide for yourself whether such a substantial change in the labeling of steak products is warranted by the fewer than 15 cases reported annually since 2000, what we do know is that the labeling rules are changing fast, and serving mechanically-tenderized medium rare steaks in restaurants may no longer be a legal option. Time (and temperature), of course, will tell. Ultimately, this is because whether the term “medium rare” survives will depend upon the validation studies governing any new labeling. USDA’s rules will require validated instructions to include, at a minimum: (1) the method of cooking; (2) a minimum internal temperature validated to ensure that potential pathogens are destroyed throughout the product; (3) whether the product needs to be held for a specified time at that temperature before consumption; and (4) an instruction that the internal temperature should be measured by the use of a thermometer. 

In turn, processors will need to demonstrate to USDA that the instructions are also “scientifically supported,” meaning they must demonstrate that: (a) the cooking instructions can repeatedly achieve the desired minimum internal temperature and, if applicable, rest time; and (b) the minimum internal time and, if applicable, rest time achieved by the instructions will ensure that the product is fully cooked to a level designed to destroy any potential pathogens throughout the product. On the other side of the coin, even if processors could properly validate their cooking instructions, it may be that we see some major restaurant chains shift away from using these products altogether.

Indeed, once the new labeling requirements go into effect, then restaurants will have a difficult decision to make: comply with the labeling instructions, or ignore them?Responsible restaurant chains will, of course, determine that they need to comply with the instructional labels. This is because the instructions, themselves, anticipate (or, at least warn) that the product at issue could possibly contain pathogens and thus must be cooked to a predetermined temperature in order to render that product safe for consumption. If those instructions are ignored, however, and a customer becomes sick (or, even dies, as a result), that company could be exposed to significant punitive damages for disregarding a known risk. Thus, the only responsible course will be to either:  (1) refine internal policy to ensure that all such products are cooked to the recommended temperatures; or (2) to purchase steaks that are not mechanically or needle tenderized. There really will be no other options.

So, the most likely longer term result, in my opinion, may be that the restaurant industry will begin to move away from needle or mechanically-tenderized products, unless and until those products can be subjected to processing interventions (like irradiation) that will allow the end users to prepare and then serve them somewhere south of well-done.  

So, if you like selling or serving (or, I suppose, eating) steaks that can be cooked medium rare, you may want to watch these new rules closely. In in the end, “medium rare” may become much more rare you think.