Tag Archives: compliance

Robert Rogers
FST Soapbox

Validating Your Foreign Material Inspection System

By Robert Rogers
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Robert Rogers

The Food Safety Modernization Act (FSMA) requires that food manufacturing and processing companies identify potential hazards within their production systems and then:

  • Put in place preventive controls to address those hazards,
  • Monitor those preventive controls to ensure their effectiveness &
  • Provide documentation proving compliance with these requirements.

There are also requirements for each company to develop and establish its own plan identifying potential food safety hazards and preventive controls to counter them, and to establish the monitoring procedures that will verify the efficacy and reliability of the preventive controls.

Validating, verifying and monitoring the performance of the systems that ensure that only safe food enters the market enables food manufacturers and processors to meet the specific regulatory standards mandated by the countries where they operate and sell. This enables them to avoid product recalls that are costly and that severely damage brand identity. But these processes, in addition to satisfying regulators, also play a valuable part in protecting the companies from potential liability lawsuits, which can often be even more damaging.

The preventive controls most often used to effectively deal with such identified hazards are inspection systems (checkweighers and metal detection, X-ray and machine vision inspection systems) that quickly and efficiently detect non-standard and contaminated products and defective packaging and reject them from production lines before they can enter the marketplace. The performance of these systems must be validated, verified and monitored on an ongoing basis to ensure that they are performing as intended.

These terms–validation, verification and monitoring–are often used interchangeably, creating confusion within organizations and across industries because people interpret and use these terms in different ways. In fact, each term identifies a distinct process that has a clear purpose and role to play at different points throughout the equipment lifecycle. It is important to understand the purpose of each process to make sure that validation, verification and routine performance monitoring tests are performed to comply with regulatory requirements, particularly where the equipment is designated as a Critical Control Point (CCP).

Validation

The fundamental act of “validation,” when applied to inspection systems that are part of a food manufacturing or processing production line, is conducting an objective, data-based confirmation that the system does what it was designed, manufactured and installed to do. The International Featured Standards (IFS) organization defines validation as “confirmation through the provision of objective evidences, that the requirements for the specific intended use or application have been fulfilled.” In 2008, the Codex Alimentarius Commission defined validation as, “Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.” An important part of the validation procedure is the production of detailed data that demonstrates to line managers and to regulators that the system is operating as designed.

The manufacturer of each inspection system will validate its performance before delivery, testing it with generic products and packaging similar to what the customer will be producing. But that is only the beginning of the validation process. Onsite, that same system needs to be validated when inspecting the specific products that the production line where it will operate will be processing and/or packaging. This is ideally done at the time the system is originally installed in a production line, and then becomes one element of a complete program of validation, periodic verification and ongoing monitoring that will keep the system operating as intended and ensure that products are adequately and accurately inspected, and that accurate records of those inspections are kept.

It is critical for producers to remember, however, that the original onsite validation relates only to the specific products tested at the time. As new or additional sizes of products are developed and run on the production line, or packaging (including labeling) changes, the system will need to be re-validated for each change.

Verification

Verification is the process of periodically confirming that the inspection equipment continues to be as effective as when it was first validated. The verification process uses standard, established tests to determine whether the inspection system is still under control and continuing to operate as originally demonstrated. This verification process is conducted periodically at regular intervals to provide evidence-based confirmation that the system continues to be effective as specified. Formal performance verification is typically an annual process, to support audit requirements. It should continue throughout the productive life of the system.

Both validation of an installed system and periodic verification of operating systems can be conducted either internally by the end-user, or by the supplier of the equipment. Validation and verification services are often included as part of equipment purchase contracts.

Monitoring

Routine performance monitoring, as distinct from periodic verification, consists of a series of frequent, regular performance checks, during production, completed to determine whether processes are under control and to confirm that there has not been a significant change in the system’s performance level since the last successful test. The monitoring frequency may be as often as every two hours, depending on company standards, industry standards and/or retailer codes of practice.

If the monitoring process finds that a particular device is out of specification, all product that has passed through the production line since the last successful routine performance-monitoring event must be considered suspect and re-inspected.

In many cases, it is line operators that conduct online performance monitoring. However, many of today’s more sophisticated product inspection systems incorporate built-in performance monitoring software that automates this process and alerts operators when deviations occur. This valuable software feature removes any human error factor from the monitoring activity to help ensure that inspection processes are still being performed properly. It also provides documentation that will guide the end-user company’s QA groups in their continuous improvement efforts, and that will also be a valuable asset in the event of an inspection visit from regulators.

Routine performance monitoring can also have a direct impact on the production line’s OEE. Installing a system with built-in condition monitoring capability that automatically detects when the system may need correction and communicates that information directly to line operators reduces the frequency needed for verification testing, maximizing the line’s production uptime.

Reliance on the experts

Finally, food manufacturers and processors should remember that, while they are knowledgeable experts regarding their products, it is their equipment suppliers that are the experts on the capabilities and qualification procedures of their equipment. That expertise makes them the best source of reliable recommendations on questions from the most effective inspection equipment type for specific product needs, where to place that equipment on the production line for optimum results and how to validate, verify and monitor its performance.

Relying on these experts to conduct onsite validation and to advise on conducting periodic verification and ongoing performance monitoring can reduce both the time needed for the original onsite validation time and that needed for verification and ongoing monitoring procedures, increasing productivity.

Companies can also rely on these experts to be knowledgeable on the most current food safety regulations and the technology that affect equipment validation. It is critical for their success that they stay current on those topics, and sharing that knowledge is a valuable part of their service.

Approved

Finding Compliant Suppliers May Be Getting Easier

By Maria Fontanazza
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Approved

Six years ago, following FSMA being signed into law, Associated Wholesale Grocers, Inc. (AWG) knew it had to implement a supplier approval program to comply with the Preventive Controls rule. At the time, it had a manual process for managing the records of its 3000+ suppliers. The company needed an effective place, accessible any day of the year (and at any time), to collect and store all of its corporate and food safety documentation.

“I come from a manufacturing program where I was used to having a very robust supplier approval program,” says Shelly Stegner, director of food safety for AWG, a grocery co-op. “But in distribution companies such as AWG, food safety hasn’t necessarily been the culture, because we don’t do any reprocessing or repacking, or touch the product. When we had to comply with [FSMA], it was a whole new thing for AWG, and we knew we had to roll something out.”

AWG spent about two-and-a-half years looking for a company that could help not only manage documentation but could also give them control over the documents from a visibility perspective. After conducting thorough research, AWG selected Repositrak Inc.’s cloud-based Compliance Management solution. The product was recently launched to help companies during the sourcing process, assisting them with supplier qualification, order negotiation and on-boarding a new supplier. The solution also highlights compliant vendors based on business and safety requirements.

Food Safety Tech: What are the advantages and drawbacks to using an automated solution like Repositrak?

Shelly Stegner: It’s an easy way to keep track and retain all the records that you’ve never been able to retain before. And not only can you retain them, but there are also visual statistics behind the documents (which you don’t have when with hard copies). It’s not just having the documents—it’s actual usable data when you use [Repositrak] that helps drive efficiencies within our company, and it helps decrease our risk and liability with vendors—for example, we know that their certificate of insurance has expired, whereas before [using Repositrak], we didn’t know that.

The drawbacks are cost. Is it the cheapest option out there? No. But is it the most efficient option that we found? Yes. A lot of the companies may have been cheaper, but we would have had to hire an individual to do all the work. There is a cost associated with it, so [some] vendors are hesitant. The other drawback is that the industry overall has many different solutions, so if the supplier is not using Repositrak for their supplier approval program, it’s another point of entry. Maybe it only takes 30 minutes to do it, but it’s still something else that they have to do.

I think it’s becoming easier for vendors with Repositrak as we get more traction and as it becomes more of an industry-known [product]. Suppliers only have to upload documents once, and it automatically reaches all their customers. So for them, the more [suppliers] that are on one system, the easier it is for the whole industry.

FST: What are the challenges to implementing this type of system?

Stegner: For a company that was completely in the Stone Ages, we didn’t even have a list of all of our active vendors—so we thought we had 6000 active vendors, and we only had a little more than 3000. Just getting the information to Repositrak about active vendors and contacts proved to be the most difficult thing for us. Once we got Repositrak the key information, they ran with it.

FST: From time management perspective, what are the savings?

Stegner: Before we had nothing in place. Now, during my third-party audits or when FDA arrives, I can show them where we are in compliance when they ask about our supplier program. It saves me a ton of time in that regard.

Now when I have a recall, I can go into the system and look up a contact, versus waiting to get a contact from a category manager. If I need to issue a recall, I can see if [the vendors] have reviewed our recall program and issue it without waiting on that either.

As far as the time it takes to approve documents, there’s an increased time, but there’s also an awareness that we never had before. So not only are we collecting the documents, but now we are building a whole food safety culture that also has a new awareness and understanding of what it means to distribute safe food.

FST: What are the general challenges you see companies facing, especially in the area of compliance and having visibility throughout their supply chain?

Stegner: I think there’s a challenge with some companies on keeping information confidential because they simply don’t want to share information.

As far as traceability goes, our company is challenged with technology. [There’s] the financial need of upgrading our technology to have the true traceability that has so increasingly become required by consumers from farm to fork. A great deal of technology is needed to understand that in real time.

The farmer has their traceability, and the supplier has their traceability, we have ours, and then there’s the retailer—it’s tying all those together that proves to be a bit of challenge.

Gluten free

FDA Project Finds Gluten-Free Labeled Products Meeting Standards

By Food Safety Tech Staff
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Gluten free

Accurate labeling of gluten-free products is a big deal for consumers who have celiac disease, as they can suffer potentially serious health issues when they eat gluten. FDA set standards for the labeling of gluten-free products in August 2013 (with a compliance date of August 5, 2014) and recently announced results of a sampling assignment that was conducted to assess compliance with the final rule.

Of the 702 samples taken from 250 products labeled as “gluten-free”, FDA found that more than 99.5% of the samples to be in compliance with the agency’s requirement.

“Of the total number tested, five samples from one product source contained gluten in excess of the regulatory limit of 20 parts per million (ppm), for a product-based rate of compliance with that requirement greater than 99.5 percent. A voluntary recall was conducted to address concerns related to the violative samples. In addition to carrying out the recall, the manufacturer conducted an extensive root cause analysis and immediately implemented additional corrective actions to prevent recurrence.” ­ – FDA

The analytical results are available on FDA’s website.

SQFI Logo

SQF Version 8 Released: Understand the Revisions

By Food Safety Tech Staff
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SQFI Logo

A new version of SQF was recently released. To get up to speed on the revisions, experts LeAnn Chuboff, senior technical director at SQFI and Jennifer Lott, food safety & auditing technical manager/senior safety auditor at SGS will walk attendees of an upcoming webinar through SQF V8 and how it connects to FSMA compliance.

Chuboff and Lott will discuss the role of senior management in the process, the need for greater environmental controls, approved supplier programs, and the requirements surrounding food fraud and allergens. They will also help attendees understand the tools and resources available to help prepare for the new version, along with digging deeper into FSMA implementation in the area of risk, supply chain preventive controls, adulteration and allergens.

Learn more during the webinar, New SQF Version 8 and Compliance with FSMA Rules, on April 25, 2017 at 1 pm ET.

Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories
Food Genomics

Microbiomes a Versatile Tool for FSMA Validation and Verification

By Douglas Marshall, Ph.D., Gregory Siragusa
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Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories

The use of genomics tools are valuable additions to companies seeking to meet and exceed validation and verification requirements for FSMA compliance (21 CFR 117.3). In this installment of Food Genomics, we present reasons why microbiome analyses are powerful tools for FSMA requirements currently and certainly in the future.

Recall in the first installment of Food Genomics we defined a microbiome as the community of microorganisms that inhabit a particular environment or sample. For example, a food plant’s microbiome includes all the microorganisms that colonize a plant’s surfaces and internal passages. This can be a targeted (amplicon sequencing-based) or a metagenome (whole shotgun metagenome-based) microbiome. Microbiome analysis can be carried out on processing plant environmental samples, raw ingredients, during shelf life or challenge studies, and in cases of overt spoilage.

As a refresher of FSMA requirements, here is a brief overview. Validation activities include obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified microbial hazards. In other words, can the food safety plan, when implemented, actually control the identified hazards? Verification activities include the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended, and to establish the validity of the food safety plan. Verification ensures that the controls in the food safety plan are actually being properly implemented in a way to control the hazards.

Validation establishes the scientific basis for food safety plan process preventive controls. Some examples include using scientific principles and data such as routine indicator microbiology, using expert opinions, conducting in-plant observations or tests, and challenging the process at the limits of its operating controls by conducting challenge studies. FSMA-required validation frequency first includes before the food safety plan is implemented (ideally), within the first 90 calendar days of production, or within a reasonable timeframe with written justification by the preventive controls qualified individual. Additional validation efforts must occur when a change in control measure(s) could impact efficacy or when reanalysis indicates the need.

FSMA requirements stipulate that validation is not required for food allergen preventive controls, sanitation preventive controls, supply-chain program, or recall plan effectiveness. Other preventive controls also may not require validation with written justification. Despite the lack of regulatory expectation, prudent processors may wish to validate these controls in the course of developing their food safety plan. For example, validating sanitation-related controls for pathogen and allergen controls of complex equipment and for how long a processing line can run between cleaning are obvious needs.

There are many routine verification activities expected of FSMA-compliant companies. For process verification, validation of effectiveness, checking equipment calibration, records review, and targeted sampling and testing are examples. Food allergen control verification includes label review and visual inspection of equipment; however, prudent manufacturers using equipment for both allergen-containing and allergen-free foods should consider targeted sampling and testing for allergens. Sanitation verification includes visual inspection of equipment, with environmental monitoring as needed for RTE foods exposed to the environment after processing and before packaging. Supply-chain verification should include second- and third-party audits and targeted sampling and testing. Additional verification activities include system verification, food safety plan reanalysis, third-party audits and internal audits.

Verification procedures should be designed to demonstrate that the food safety plan is consistently being implemented as written. Such procedures are required as appropriate to the food, facility and nature of the preventive control, and can include calibration of process monitoring and verification instruments, and targeted product and environmental monitoring testing.

Melanie Neumann, Neumann Risk Services

Risk Mitigation and Compliance Management Strategies – Tightly Intertwined but Very Different!

Melanie Neumann, Neumann Risk Services

Melanie Neumann of Neumann Risk Services, LLC, (NRS) a global food safety and compliance law firm shares her thoughts on the similarities and differences of risk mitigation and compliance management, as well as the year ahead and what companies should be focusing on with regard to these key risk management topics.

Q.  Risk Mitigation and Compliance Management are often grouped together – in your view what is the key distinction between the two?

A.  The two are very much linked and very much codependent yet they are separate topics that need to be identified, implemented and managed differently.  Independent strategies need to be put together that are different, separate and apart based upon a company’s strategy and risk tolerance.  [more]

Q. What risk mitigation approach is most realistic, and typically deployed by the food & beverage industry?

A.  With risk management, there are 4 types of risk mitigation strategies that are typical. I’ll break down to how you can manage risk very simply – 1) avoid it, 2) limit it, 3) transfer it, and 4) if you can’t do any of these 3, you can accept it.  [more]

Q.  How does your risk management strategy tie into compliance management?

A. Tying it together, risk management identifies the risk, and establishes a way to manage that risk appropriately. Compliance management is assessing whether the process of managing that risk is actually working the way you intended it, and is meeting laws or regulatory requirements if there are any that apply.  [more]

Q.  What are some of the key risk mitigation and compliance management considerations and initiatives companies should be thinking about in 2017?

A.  As companies continue to develop and execute upon their risk mitigation and compliance management strategies – they should be focusing on: 1- Showing your work; and 2 – leveraging your data for positive outcomes.  [more]

Q. Any parting thoughts on what you’ve shared today?

A. Right now, frankly, the stakes are higher than ever.  Liability concerns are greater than ever, too.  “knowledge” is being imputed on companies more than ever before for food safety issues that occurred in the past and rear its head again in the future.  [more]

Learn how SafetyChain’s solutions can help you more effectively reduce risk and ensure program compliance – www.SafetyChain.com

Food Safety Law Firm Neumann Risk Services, LLC at the Food Safety Consortium

Neumann Risk Services, LLC (NRS), IL, a law firm where law, food, and science converge—founded by global food safety attorney Melanie Neumann, J.D., M.S., will be participating in the 2016 Food Safety Consortium. Melanie Neumann will moderate and speak at “Ask the Experts” Panel and Discussion Group on the topic of Post-FSMA Compliance Challenges and Risk Management on Thursday, December 8th at 10:30 – 11:15 am at this year’s Food Safety Consortium. NRS focuses on food law and regulatory compliance and offers a dynamic combination of food safety and food law skills to provide a unique, specialized approach to understanding and implementing the changing global food safety regulations.

Visit our exhibit and meet with NRS to explore your needs and how NRS can help—especially regarding legal, regulatory, business and brand counsel and consulting topics such as: recall and crisis management, responses to regulatory actions,  advertising/labeling regulations, supply chain management optimization, FSMA compliance and implementation, supplier and customer contract matters, and other matters that require regulatory interpretation, legal assistance, and preservation of attorney/client privilege.

Let NRS advise your company on how to build holistic, global food safety programs integrated into enterprise risk management programs—all to protect and preserve the public health, business efficiencies, and brand reputation.

If you would like more information, please email info@neumannriskservices.com or call 507-828-4536.

Compliance

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

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?

FSMA

Small Businesses: FDA Releases Preventive Controls Guidance

By Food Safety Tech Staff
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FSMA

In order to help small businesses with implementation of the FSMA Preventive Controls for Human Food and Animal Food rules, FDA has released compliance guidances. In an FDA release, the agency highlighted the following:

  • Small businesses (fewer than 500 full-time employees): Compliance with the human and animal food rules required by September 18, 2017
  • Very small businesses (those averaging less than $1 million per year in human food sales or $2.5 million per year in animal food sales): Required to maintain records supporting Qualified Facility status as of January 1, 2016
  • Qualified facilities must comply with the human and animal food rules by September 17, 2018

Both guidances are available on FDA’s website:

Guidance for Industry: What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide

What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals

Joann Givens, FDA

What to Expect Now that the First Big FSMA Compliance Dates Are Here

Joann Givens, FDA

The first major compliance dates have arrived for the preventive controls rules for human and animal food under the FDA Food Safety Modernization Act (FSMA). Some members of the food industry have expressed concern and uncertainty about enforcement measures that may accompany September 19, 2016. That’s the date when larger businesses must comply with certain new standards. Human food facilities must meet preventive controls and Current Good Manufacturing Practice requirements (CGMPs); animal food facilities must meet CGMPs. (The larger animal food businesses have an additional year to meet the preventive controls standards.)

Joann Givens, co-chair of the FSMA Operations Team Steering Committee and director of FDA’s Food and Feed Program in the Office of Regulatory Affairs, addresses questions that have been raised about what the next few months will look like for human food facilities required to comply with the CGMP and preventive controls requirements and animal food facilities required to comply with the CGMP requirements.

What happens next in terms of FDA enforcement of these new standards?
We know that this is new territory for food companies; it’s new territory for us too. For years we’ve been talking about the FSMA rulemakings and our implementation plans. Now, an important compliance date is here for some companies. As we enter this new chapter, the FDA’s primary focus will continue to be on education, training and technical assistance to help companies comply with the new requirements.

A top priority for FDA is providing the framework for industry’s implementation of preventive controls and CGMP requirements. We recently issued draft guidance documents that provide more detail on how to comply with the new standards, and there are more guidances to come, about two dozen planned over the next few years. We intend to continue this dialogue and collaboration with regulated industry to ensure that everyone understands and engages in their respective roles in food safety.

This first year of compliance will affect the larger businesses, generally those with 500 or more employees. Many businesses of that size already have a HACCP (Hazard Analysis and Critical Control Points) program; we don’t expect them to need to make many changes to come into compliance. Aspects of the CGMP and preventive controls rules are similar to HACCP, a food safety system that started with industry. (The human and animal food rules have staggered compliance dates; smaller businesses have a year or more additional time to comply.)

Does the focus on education mean that companies won’t really be held to these standards yet?
No. The FDA’s mandate is to protect public health and, when necessary, the agency will act swiftly. But keep in mind that our primary goal, not just in the first months but going forward, is to work with the food industry to create a culture of food safety, a culture of compliance with procedures, processes, and practices that we know will minimize the risk of serious illness or death.

What is the best thing covered food facilities can be doing now?
The best thing that people in the food industry can do is take the measures required by the new rules – not just the letter of the law but what it represents in terms of transforming the food safety system. They should look at the big picture, at areas in which they could be vulnerable and proactively take action. Promptly responding to problems, even if they aren’t yet violations, can prevent them from getting to the point at which there is a concern about the safety of the food.

In addition, facilities should set up a thorough system for documenting what they do. The better the records, the more a company can demonstrate that it is meeting the legal standard. Put processes and procedures in place to prevent problems in the first place, and consider having some redundancy in the system so that if one measure fails, another can take its place.

If there is a problem, state or federal investigators will ask questions like: When problems came to your attention, what did you do? Were you proactive in looking for the problems in the first place? If you could not find a solution, did you get the right expertise? Did you educate your employees?

Where can companies go wrong?
A company’s approach should not be: “The government was here and did our inspection. We’re safe for X amount of time.” Rather we want facilities to be confident that if FDA or the state walks in tomorrow, they’ll be able to demonstrate what they’re doing to meet the new food safety requirements.

And it really is up to the management of a company to create that culture by attending to the facility and its production processes and making sure that everyone in the production chain understands what is expected and has the training and education they need to get the job done.

What is the ultimate goal?
The purpose of these rules is to create a preventive, food safety system that is self-sustaining. Everybody in a food facility should be systematically operating in a way that complies with the law.

The preventive controls requirements fulfill the paradigm shift toward prevention that was envisioned in FSMA and, in combination with CGMPs, will help protect consumers into the future.

We want to see people doing the best they can. It’s a marathon, not a sprint. They’re learning; we’re learning. We are very committed to educating while we regulate to align understanding and expectations.

This article has been republished with permission from FDA. The original version can be viewed on FDA’s website.