Tag Archives: FSMA

FSMA

FDA Updates on FSMA Training

By Food Safety Tech Staff
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FSMA

Today FDA updated its FSMA training strategy to reflect the progress made during 2016. The program, which targets farmers, small food processors and small produce merchant wholesalers, includes the following updates:

  • Cooperative agreement for small and mid-size businesses involved in local food production awarded to the National Farmers Union Foundation
  • Cooperative agreement for preparing food producers in Native American tribes awarded to the University of Arkansas in Fayetteville
  • Federal grants awarded for establishing regional centers to facilitate training under FDA’s partnership with USA’s National Institute of Food and Agriculture
FSC 2016, Ostroff and Almanza

Are Final FSMA Rules Cast in Stone?

By Food Safety Tech Staff
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FSC 2016, Ostroff and Almanza

Stephen Ostroff, M.D. will keynote at the 2017 Food Safety Consortium on November 29 | Learn moreEarlier this month Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, told attendees at the 2016 Food Safety Consortium about the agency’s commitment to a proactive food safety system. He also discussed FDA’s stance on criminal liability and took questions from the audience, one of which was:  Now that the FSMA rules are final, are they cast in stone? Does FDA have any flexibility in making changes. Listen to Ostroff’s answer in the following video.

 

FDA

FDA Issues Final Rule on FSMA Third-Party Certification User Fee Program

By Food Safety Tech Staff
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FDA

This week FDA issued a final rule that provides for a user fee program to evaluate fees and require reimbursement for work that FDA performs to establish and administer the third-party certification program. The rule, “Amendments to Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications To Provide for the User Fee Program”, is effective January 13, 2017.

FDA also announced its fiscal year 2017 fee rate for accreditation bodies that are applying to be recognized by the third-party certification program. The fee will remain in effect through September 30, 2017.

FDA on Enforcement: Our Goal is To Help, Not Punish

By Maria Fontanazza
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Over the past year and a half, much attention has been given the federal government’s commitment to prioritizing prosecution of food companies that engage in criminal behavior. In some instances, this has been used as a scare tactic, shining a spotlight on the executive responsibility of company executives.  Although focusing on executive liability isn’t necessarily a bad thing, Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, wants food manufacturers to know that FDA isn’t out to get them.

During yesterday’s opening keynote presentation at the 2016 Food Safety Consortium, Ostroff commented on FDA’s approach to enforcement. “I often have to scratch my head as why this has been such a tremendous concern in a regulated industry…sitting at FDA, we have not had any change in our thinking and approach about liability,” said Ostroff. “FDA pursues legal action against companies that are clearly negligent and clearly violating the law.” He emphasized that FDA’s goal moving into the FSMA compliance phase hasn’t changed; it’s about implementing a food safety system focused on preventive controls.

Ostroff encouraged attendees to look at the areas in which their food safety system is vulnerable, take proactive action and build redundancies into their system. “The best defense is to comply with the new requirements, and document how you are creating a food safety culture where everyone understands the expectations,” he added. “If you’re making a good faith attempt—our goal is to help you accomplish that goal, not to punish you for the attempts that you’ve made in good faith.”

The deputy commissioner also commented on the agency’s progress since FSMA’s seven rules were finalized in May, pointing out that these rules are foundational, and additional rules are to come. These rules will address lab accreditation, traceability related to imported products and a reportable food registry tool.

“If when we visit we identify very significant food safety hazards that we think pose an imminent risk of foodborne illness, we will have to take action.” – Stephen Ostroff, M.D.

Other key areas Ostroff discussed regarding agency progress and initiatives included:

  • Initial compliance date for FSMA Preventive Controls Rule (for large companies). FDA wants to be a partner in assisting companies with the preventive controls requirements. “That for us will require a lot of work on the part of those who are going to be conducting these inspections, but our goal is to help you and tell you in which areas you’re doing quite well and in which areas you can do better,” said Ostroff, adding that many of the aspects of the preventive controls rule are very similar to what many companies have already done.
  • Foodborne outbreaks. With several outbreaks in the 2015–2016 timeframe (ice cream–Listeriosis; cilantro–cyclospora; cucumbers­–Salmonellosis; Mexican-style fast food–E.coli O26; flour–E.coli O121), the Inspector General expressed concern over the FDA recall process and criticized the agency for not having  better defined timeframes. In response to that report, FDA implemented the SCORE (Strategic Coordinated Outbreak Response and Evaluation) team, which guides concrete action plans for measures that the agency must take in the areas of recalls, for example. The team consists of decision makers from key operations and enforcement offices with a goal of expediting the evaluation of compliance and enforcement options. Since April, SCORE has addressed flour contaminated with peanut protein, facilities contaminated with Listeria, Salmonella in pistachios, and baby food that was not manufactured in compliance with infant formula regulations.
  • Antimicrobial resistance. The issue is “getting attention at the highest levels of government,” said Ostroff, adding that the best way to address antimicrobial resistance is to not have to treat it in the first place—and to do this is through reducing the incidence foodborne illness. The agency is moving forward in several areas here, including addressing non-judicial use of food animals and veterinary settings; enhancing NARMS data and isolate collection; and collecting data on antimicrobial sales by species.
Attendees listen to Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, give the keynote presentation at the 2016 Food Safety Consortium.
Attendees listen to Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, give the keynote presentation at the 2016 Food Safety Consortium.

During the Town Hall part of the presentation, Ostroff was asked, with the finalization of the FSMA rules, are they cast in stone? His answer: Not necessarily. “It took five years to get in place…because we did it in a very systematic way with a lot of stakeholder input. When you put together rules that are this complicated, there’s no guarantee that you got everything right,” he said. “[We] have to recognize that sometimes some of the flaws don’t become apparent into you implement them. You always have to be of the mindset that if everything didn’t work out exactly the way things were anticipated…we always have to be open to the fact that as we move forward and implement the rules, we might have to make course corrections.”

Katy Jones, Foodlogiq
FST Soapbox

Mitigating Supply Chain Risk with Transparency and Traceability

By Katy Jones
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Katy Jones, Foodlogiq

Attend the Food Safety Supply Chain Conference, June 5–6, 2017 in Rockville, MD | LEARN MOREA recent study from The Hartman Group on the topic of transparency found that consumers are becoming more concerned about imports and the safety standards behind companies producing food and beverage products beyond U.S. borders.

So with the drastic rise in consumer expectations for food quality and safety in the past few years, how can companies ensure they’re mitigating risks in the supply chain while fostering transparency to meet consumer expectations?

To our benefit, the focus of the broader food industry and the government, as well as innovations in technology, are making it easier than ever to comprehensively track the supply chain.

Another Day, Another Food Recall, Another Listeria Scare

In today’s reality, whether we like it or not, food recalls are an inevitable part of the food industry, and adulteration in the supply chain is a key safety issue. With the wellbeing of consumers at stake, if a contamination finds its way into a brand’s supply chain, the best possible course of action is to take action on a recall using impeccable supply chain records and monitor the affected product moving throughout the chain.

With recalls being here to stay in the food industry, companies need to be prepared to handle these issues quickly and effectively. By implementing supplier management and whole-chain traceability software, allergens and impurities can be pinpointed to a specific lot of product as opposed to being limited to processing/issue date, and not knowing the source or country of origin of every ingredient (as many suppliers can contribute to one product) within the supply chain.

Additionally, with these technologies, brands can keep their supply chain transparent and compliant with growing industry regulations. With consumer standards on the line, proactive transparency can ensure that a company has a plan of attack when the inevitable hits.

A Targeted and Precise Plan

Companies and brands need to broaden their definition of food safety in order to manage and satisfy an expanded set of consumer expectations. The traditional, linear “one-up and one-back” (OUOB) approach to supply chain is no longer acceptable when it comes to comprehensive supply chain transparency.

Consumers need a targeted and precise plan when dealing with the safety of their food—it’s no longer just about whether the food safe to eat. The definition has expanded to include safety around ingredients and country of origin. Awareness of where a product came from and where it is going next is not an acceptable method if a company wishes to foster transparency with customers and effectively manage recalls. In addition, these standards are emphasized by federal regulations like the FSMA and FSVP—the industry is now shifting towards preventative approaches to safety matters, as opposed to reactive. FSMA requires food manufacturers to increase focus on prevention rather than response to contamination incidents, which will require a comprehensive view of the entire supply chain.

Brands will need to develop strong food safety plans with streamlined audits and compliance records, verifying supply chain partners and executing corrective actions for suppliers that are not in compliance with the process and food safety plan set in place. In establishing this process, having the technology to support it is paramount in ensuring that suppliers are sticking to the food safety practices necessary to follow industry regulation and exceed consumer expectation.

Transparency in Today’s Complex Food Paradigm

As the global food supply continues to grow in volume and complexity, brands have an opportunity and an obligation to adapt to the food paradigm. According to a Label Insight study, 94% of consumers say transparency from food brands is the #1 factor that impacts purchase. Brands are no longer able to blame a supplier’s lack of transparency or unreliable records for exposing consumers to unsafe products but instead, the brand is solely held accountable.

Transparency and proactivity were optional in the past, but are now established as fundamental components of a brand’s safety plan if they are to adapt to the changing industry landscape as well as consumer demand. As recalls are bound to happen, proactivity and transparency can ensure that a company is one step ahead of an outbreak at all times.

The fact is, adapting to this shifting environment and aligning with these best practices and the technologies that enable them is critical to the success of the supplier, distributor and across the whole supply chain. Food companies must look to utilize big data analytics and intelligent supply chain mapping technologies in order to improve transparency and increase traceability. With the ability to track ingredients back and forth across the supply chain, these technologies enable a safer consumer experience as well as provide tremendous business value in eliminating inefficiencies, managing supply chain issues, and effectively protecting the brand with the insights offered.

Randy Fields, Repositrak
Retail Food Safety Forum

The Fresh Food Supply Chain and Product Safety

By Randy Fields
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Randy Fields, Repositrak

Attend the Food Safety Supply Chain Conference, June 5–6, 2017 in Rockville, MD | LEARN MOREFresh foods are critically important to grocery retailers because these categories help create a point of differentiation from competitors. Store operators highlight the fresh sections in ads, promote the categories with in-store signage and now support the departments digitally and through social media. This isn’t to say the center store dry grocery items aren’t marketed, but they don’t get the advertising and promotional love that the produce, meat, dairy, deli, bakery and floral areas receive.

Given this focus, retailers and their suppliers work diligently to ensure the safety of the fresh products offered. They know that one slipup in produce or the deli can wreck the company’s reputation for months or longer. This is particularly true for the many fresh products that don’t have a brand standing behind them to share the impact (or blame).

Ask retail food safety directors where they spend most of their time and the answer 90+ times out of 100 is in the fresh areas. There are simply more things that can potentially go wrong in fresh and less that can go wrong with dry grocery. Sure there is the occasional ingredient issue, but the center store doesn’t have to worry about spoilage or even packaging problems now that nearly everything is tamper proof.

The bioterrorism act mandates that each link in the supply chain knows where their ingredients or product came from and where it was distributed. Recently, much effort has gone into developing traceability technologies and processes with the produce supply chain taking the lead. Growers and their trading partners are piecing together systems that allow practitioners to follow each batch of product through to the retail store, but the operative phrase is “piecing together.” Very few technologies can provide complete farm-to-fork traceability without standard product identification codes used by all participants in the supply chain. When a participant does not use the standard product identifier, visibility to the path of a product ends.

On the regulation front, the seven FSMA rules move the emphasis of the FDA from detection and response to prevention, which impacts both fresh and shelf-stable products. On a practical level, however, compliance with the rules is often more challenging for fresh products because of their limited shelf life. Also, some of the rules apply specifically to produce, meaning retailers and their produce suppliers need to pay special attention to preventing foodborne illness in the department.

At the recent Produce Marketing Association’s Fresh Summit in Orlando, Bob Whitaker, Ph.D., the trade group’s chief science & technology officer, and Jim Gorny, Ph.D., vice president, Food Safety & Technology, both emphasized the importance of communicating each retailer’s and supplier’s compliance with the FSMA regulations to the consumer. The North American Meat Institute, International Dairy-Deli-Bakery Association and other trade groups representing the marketers of fresh products have also been very active in helping both retailers and suppliers comply with the new regulations.

Beyond FSMA, retailers and their fresh foods suppliers need to do more work to not only ensure a safer supply chain, but to let consumers know they are working on food safety every day. Transparency needs to extend throughout the supply chain so suppliers and carriers can report on any potential safety issue from the farm to the checkout stand, because retailers are requiring more support from suppliers and more documentation for each load received. And, audits need to be periodically conducted to ensure accepted industry best practices are being followed.

Technology is helping the food safety process, especially in the fresh area, by organizing documentation for FSMA compliance and by providing supply chain transparency. The systems now available integrate all product and vendor information into a retailer’s ordering systems to ensure every requirement is met before a purchase is completed. They also send out alerts when additional details are required and they confirm that each lot shipped adheres to accepted best practices for food safety.

At the end of the day, all items sold in a supermarket or online must be safe for the consumer. The challenge is somewhat bigger with fresh foods than it is with dry grocery, so retailers and their suppliers must work that much harder to ensure the safety of products sold to their customers. A combination of accurate document management, compliance audits and traceability technology is now the most likely scenario to accomplish this goal.

FDA

FDA’s Offers Answers on Food Facility Registration

By Food Safety Tech Staff
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FDA

FDA has released a draft guidance to help food facilities that manufacture, process, pack or hold food for consumption in the United States. Aptly titled “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Draft Guidance for Industry”, the document is a 15-section Q&A addresses Food Facility Registration, of which the renewal period began on October 1 and ends December 31. The seventh edition of the guidance also adds information related to the Amendments to Registration of Food Facilities final FSMA rule.

The agency is accepting comments on the draft guidance until February 6, 2017.

GFSI

GFSI Hosts Government and Industry to Discuss Food Safety Issues

By Food Safety Tech Staff
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GFSI

Next week GFSI will be hosting 200 industry and government professionals to discuss leveraging GFSI in FSMA implementation. The GFSI Expert Briefing takes place on November 15 in Washington, D.C., and will look at the role of GFSI in the marketplace and the domestic and international collaboration necessary to comply with new regulations.

“Science guides industry and policymakers to the same place as we work towards our common objective of ensuring a safe food supply for consumers,” commented Mike Robach, chair of the GFSI Board of Directors in a press release from The Consumer Goods Forum. “Public-private dialogue and collaboration is paramount to achieving this goal.”

Speakers at the event come from a range of international companies, including Cargill, Dole, McDonald’s, Target, Walmart and Wegmans. FDA and other national policymakers and legislators will also be present. Industry briefings take place in the morning and afternoon.

SGS, food safety

Food Defense and FSMA

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SGS, food safety

FSMA rule for “Mitigation Strategies to Protect Food against Intentional adulteration” (or FSMA Intentional Adulteration rule) is aimed at protecting the U.S. food supply against acts intended to cause wide-scale harm to public health. The rule is a major breakthrough, since it takes food defense to a practical level, into the processes of a food facility. The notion of food defense has been around for many years, but it is safe to say that FSMA gave food defense a new momentum by incorporating it into a regulatory framework, hence facilitating its integration into the food system.

To understand intentional adulteration, it would be essential to cover the basics. PAS 96 and other schemes have taught us those basics, and FSMA created an environment for food defense notions to grow and evolve. Growth and evolution require a sustainable environment, a robust food defense system.

It is critical to consider threats and vulnerabilities in dealing with food defense at the planning stage. FSMA Intentional Adulteration rule makes reference mainly to vulnerabilities as a start. However, it is up to the facility to decide how far it would be willing to go to safeguard its food supply chain.

sgs_fooddefense_fsmaAfter all, the scope of food defense is not confined within the boundaries of the facility.  An “inside-out” vulnerability assessment may prove to be effective, but a complementary outside-in analysis would render food defense more comprehensive, thus expanding its scope into critical areas within the supply chain.

Therefore, the Threat Assessment and Critical Control Point (TACCP) methodology of PAS 96 combined with the vulnerability assessment and food defense management requirements of FSMA Intentional Adulteration rule would be a winning combination in addressing FSMA compliance and mitigating intentional adulteration risks across the entire food supply chain.

With more than 130 years experience in Agriculture and Food businesses, we understand the challenges that you face. Protect your brand, build customer trust and open the door to a more profitable business with food industry solutions from SGS.

From training and inspection, audit and certification, testing and advisory services to retail store checks and mystery shopping our global team of industry experts help you guarantee that your operations meet the highest global standards.

Quality, safety and efficiency are key drivers in the food value chain. Each of these elements impacts on the sustainability of your business, the desirability of your products and the marketability of your business.

Hank Karayan, SGS North America, Inc. Global FSMA Program Director

Compliance, food safety

Preventive Controls for Animal Food: What Does this Mean to Pet Food and Feed Manufacturers?

By Debby L. Newslow, Erika Miller
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Compliance, food safety

The Final Rule on Preventive Controls for Animal Food (21 CFR 507) was released in September 2015. The first compliance dates for CGMPs arrived in September 2016. All facilities that manufacture, process, pack or hold animal food for consumption in the United States are required to comply (see Figure 1 information on compliance dates.) Non-compliance is considered a prohibited act, but nonetheless this rule has not received the same amount of press as its human food counterpart. We must begin to spread awareness, because this rule has the potential to fundamentally change the pet food and animal feed industries over the next four years. Unlike human foods, animal food is typically intended to be fed as a sole source of nutrients. Thus, the regulation is fairly comprehensive and strict.

Business Size CGMP Compliance Date PC Compliance Date
Business other than small and very small One year Two years
Small business (fewer than 500 full-time employees) Two years Three years
Very small business (averages less than $2.5 million per year, during the three-year period preceding the applicable calendar year in sales of animal food + market value of animal food manufactured, processed, packed or held without sale Three years Four years except for records to support its status as a very small business
(January 1, 2017)
Figure 1. Compliance dates for CGMPs and PCs for Animal Food (from fda.gov).

During the 2016 Food Safety Consortium, Debby Newslow and Erika Miller will instruct: FSPCA Preventive Controls for Animal Food (21CFR507) Training | REGISTER FOR THE WORKSHOPSimilar to the Preventive Controls for Human Food regulation (21 CFR 117), there are two parts to the Animal Food rule: Current Good Manufacturing Practices (CGMPs) and Preventive Controls. Figure 2 provides more detail on the Subparts of the Regulation. Also, animal food covered by specific CGMP regulations must still comply with those regulations (specifically low-acid canned food and medicated feed).

Those who have taken a Preventive Controls Qualified Individual (PCQI) course will notice the remarkable similarity to the structure of the Human Food Rule. This is by design, for our animals are often a part of the family for whom we want to provide the highest level of quality and safety possible. That said, there is some overlap between the two regulations. For instance, when human food byproducts are diverted to use in pet food or animal feed, the human food CGMP rules apply to that food intended for use as animal food.

Subpart Topic
A General Provisions
B Current Good Manufacturing Practice
C Hazard Analysis and Risk-Based Preventive Controls
D Withdrawal of Qualified Facility Redemption
E Supply Chain Program
F Requirements Applying to Records that Must Be Established and Maintained
Figure 2. Subparts of 21 CFR 507, Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Food for Animals.

What Does this Regulation Mean for the Pet Food Industry?

Large companies that produce commercially available pet foods available in grocery stores and big box retailers (such as Pedigree, Iams, Nutro, Purina, etc.) are typically already compliant to a voluntary GFSI-approved food safety scheme (FSSC 22000, SQF, etc.). These companies already have most necessary processes in place to be compliant. There may be adjustments related to terminology, documentation, records and hazard analysis expansions to include mention of Preventive Controls.  However, most of the work has been completed already and only clarifications, in most instances, should be required.

However, there are many small “mom-and-pop” type establishments making niche pet food with high-quality, organic ingredients that may not have much knowledge about this regulation. These types of manufacturers want to make the best, safest, highest quality product they possibly can, but without knowledge and education, they may not know the questions to ask to point them in the right direction. When an inspector arrives and asks to see the written hazard analysis, even a high-quality niche processor may end up with the deer-in-the-headlights stare if they do not understand the question. This regulation has the potential to significantly impact their business, but in a small business most folks wear many hats, and it is not always possible to just jet away for a few days to attend a specialized training class.

It was indicated during our Lead Trainer course that FDA is developing a clear proactive approach to their inspections related to this rule. Our Lead Trainer courses also emphasized that the inspectors’ focus will be on the reasonably foreseeable hazards and potential hazards to ensure that each is in control. Control can be achieved through a Preventive Control or some other process, such as a GMP based pre-requisite program.

In order to be as effective and efficient as possible, it is critical that an organization understands the requirements of this regulation. For example, the Food Allergen Labeling and Consumer Protection Act (FALCPA) does not apply to food for animals, nor are there allergen provisions included in 21 CFR 507. Certainly there are specialty manufacturers that make special recipes for those pets that may have an allergy or sensitivity (i.e., wheat, rice, etc.); however, this is completely different than the required approach to allergens for the production of human food. The pet food or feed manufacturer is not bound by these restrictions. However, an uninformed processor may take it upon itself to redesign a label to include an allergen declaration assuming that requirements for human food also apply to them. This could result in a great expense for graphic design, reprinting, disposal and wasting of previously printed labels, and of course the time spent on the project.

Measuring effectiveness is one oft-overlooked part of a mature and robust food safety program. Even experienced managers sometimes overlook this crucial step, so it is unlikely that most people would be able to come up with the concept on their own without assistance. If a facility has a rule in place that people must wear gloves, but do not have the experience to train on proper glove use and the reasons gloves are worn, confusion and improper glove use will result. This results in the company wasting money on providing the gloves in the first place. No matter how conscientious a program is, it still requires effective programs for identifying and maintaining records. These provide evidence of compliance with the regulation. There must also be documents in place that define the operational requirements and explain how to demonstrate effectiveness.

Industry representatives also must fully understand how to distinguish between Current Good Manufacturing Practices (CGMPs), other prerequisite programs and preventive controls, and to determine where they fit into their operation and the regulatory framework. The logic used to determine whether a specified hazard is reasonably foreseeable is based on science, experience and education. There are different record-keeping requirements for different types of controls.

It is critical to the process to ensure that reliable resources are used to develop the foundation of the program. This is considered so important that the PCQI Preventive Control for Animal Food material references examples of credible resources in each chapter. Examples of these include trade associations, universities, industry-focused events, relevant informational emails and webinars. We have experienced first-hand that expanding a professional network using these types of resources increases the rate of attrition for knowledge when a sink-or-swim situation is presented.

Keep in mind that an operation must take an active role in defining, implementing and maintaining its food safety program. It is usually recommended that a consultant knowledgeable in your food sector be engaged to assist. However, the word of the day is “assist”.  If the consultant writes a turnkey program, then whose program is it? And better yet, where are they going to be when you are in an audit and can’t explain (justify) what is stated in the program?

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