In May of 2017, the first compliance date passed for the Foreign Supplier Verification Programs regulation under the Food Safety Modernization Act (2011). Other than changing our approach to imported food safety from a reactive to a proactive way of thinking, what are some common misconceptions about this regulation, and where do we see it going in the next five to ten years?
As a Lead Instructor for the FSPCA curriculum for this course, and an administrator of public courses, I have personally had the pleasure of instructing several FDA representatives, as well as people from many different segments of the food industry, from brokers and distributors to manufacturers and retailers. This regulation affects a more diverse cross-section of people than even Preventive Controls for Human Food, but fewer people have elected to take the FSPCA course because it is not strictly required. This has resulted in a few misconceptions about the regulation being propagated throughout the industry by a few well-meaning but woefully misinformed people, the most common of which is, “I am not the importer, so I do not need to worry about this regulation,” to which I always respond, “do you mean the Importer of Record (IOR) or Importer for FSVP purposes, as they are not the same?” Invariably I get the classic deer-in-the-headlights stare, and often the subject is changed abruptly. If this is a sentiment you have heard expressed by anyone in your supply chain, please encourage them to attend our class, as we spend quite a long time discussing this very issue, and explaining why it is such a dangerous assumption.
Another frequent misconception is that the size of the importer dictates the compliance date for a food/supplier combination. This is also often not correct, as the size of the importer is only a factor when the importer is “Very Small” (less than $1 million per year average over the last three years preceding the current calendar year, including ALL subsidiaries and affiliates, whether foreign or domestic).
Right now, we are in a phase of education and outreach wherein FDA inspections often result in a recommendation for training if the result of the inspection is not NAI (no action indicated). In the next five to ten years, it is fair to assume that this initial phase will eventually expire, and companies not in compliance with the regulation may expect some additional enforcement activities. Remember that FSMA expanded the regulatory toolbox of the FDA to include additional tools for compliance enforcement activities. No one has a crystal ball to know what will happen in the future, but based on the feedback from agency representatives so far, it is expected that the education and outreach timeframe will extend for a few years at least. Therefore, we are estimating that the next five years will continue education and outreach, and then after about five years we may expect to see further enforcement if companies continue to claim ignorance or refuse to act in compliance with the tenets of the regulation.
Remember, if you use or sell food that was imported at any point in the past, whether you are acting as the Importer and/or Importer of Record or not, it is of paramount importance that you communicate with your supply chain to determine who is acting in each of those roles. As always, if you didn’t write it down, it wasn’t done, so keep a record of your communications. You may be surprised to learn how many misconceptions you uncover!
According to an article published today in the Daily Globe entitled “Opportunities Abound in Food Safety”, 2.2 million people die each year as a result of foodborne illnesses and most of them are children. Food safety is an issue that impacts every country around the world and therefore, more and more people are viewing food safety as an essential aspect of producing food products around the world.
Common pathogens associated with food production are campylobacter, listeria and salmonella. Pacific Vet Group USA is currently developing a product that will drastically reduce salmonella in the chicken crop by changing the current mode of processing chickens. The product will be administered to chickens at feed withdrawal and will reduce the potential for salmonella contamination.
For companies looking to improve food safety, like Pacific Vet Group USA, economic benefits are available because foodborne illnesses tied to processing facilities, farms, or even restaurants have been known to put them out of business.
At D.L. Newslow & Associates in Orlando, we understand the importance of food safety and can cater food safety training programs to the specific needs of your business. We offer the industry’s best consulting and customized on-site food safety training. Give our Orlando office a call today at 407-290-2754.
According to a press release published on the Business Wire and endorsed by the Institute for Credentialing Excellence, advancement in food science and technology has dramatically changed the food chain system.
A statistic released by the United Nations claims that total food production in the United States alone went from 287 million metric tons in 1965 to more than 674 million metric tons in 2010. Typically, more food means more risk of food-borne illnesses, but the U.S. Center for Disease Control and Prevention estimates that 48 million people in America got sick in 2011 from food-borne illnesses, a significant decrease from the total of 78 million cases in 1999.
What caused this extreme shift? Improved regulation and oversight from food safety professionals likely prevented almost 30 million citizens from becoming sick due to food-borne illnesses. These professionals monitor the food supply chain to ensure that they are not exposed to conditions that lead to food-borne illness epidemics.
Food safety professionals are trained to enforce rigorous standards set by national agencies such as the U.S. Food and Drug Administration (FDA) as well as state and local governments. Organizations such as the National Registry of Food Safety Professionals (NRFSP) can help uphold regulations by maintaining certification programs for food safety professionals, ensuring they have the knowledge to assess whether ingredients, processes, and facilities are safe.
“Food safety professionals are vital in making sure what we eat is safe every step along the way,” says NRFSP CEO Larry Lunch. “Armed with knowledge of federal, state, and local standards and regulations, certified food safety professionals help food producers and retail managers and handlers avoid spreading potentially catastrophic diseases.”
In 2011, the FDA was tasked with creating and implementing new standards and safety systems through the U.S. Food Safety Modernization Act. This act has allowed the agency to shift its focus from responding to contamination to preventing it, and education and enforcement systems have been updated to keep up with food protection standards.
In conclusion, food safety professionals play a vital role in protecting consumers from nasty food-borne illnesses. Through the enforcement of strict standards created by agencies such as the FDA, citizens can feel safe knowing that they are protected against these diseases. Certification programs are essential to saving lives; this is why we at Newslow and Associates offer food safety workshops, consulting, and on-site training. If you are interested in learning how Newslow can help you business make safer food chain decisions, please give us a call today at (407)290-2754.
Are you finding that your food service business is afflicted with problems that do not necessarily have an identifiable cause? If so, implementing Root Cause Analysis (RCA) may help. RCA identifies the factors that resulted in the nature, the magnitude, the location, and the timing of harmful outcomes in the past in order to identify which behaviors, actions, inactions, or conditions must be changed in order to prevent recurrence of similar harmful outcomes. Root Cause Analysis also helps to attain better consequences.
In the food industry, there is a need for production-based RCA due to quality control and manufacturing. It is absolutely necessary for your company to incorporate RCA as a tool for continuous improvement if your goal is to always strive to be better and have the highest possible standards.
In order to perform a Root Cause Analysis, begin by defining the current problem. Gather data and evidence, creating a timeline of events that lead to the crisis. Identify the causes associated with each step in the sequence towards the defined problem or event and recognize potential root causes that may have led to the event. Distinguish solutions that are effective and prevent recurrence with reasonable certainty. Also, be certain to obtain a consensus agreement among your fellow employees. Lastly, implement these root cause corrections, and ensure the effectiveness of these solutions by observing the results.
Our trained experts at D.L. Newslow & Associates understand that the process of Root Cause Analysis can be difficult to implement. That’s why we offer training and consulting on RCA. If you are finding that your business is facing problems that you simply cannot deal with on your own, please contact our trained food industry experts at (407)290-2754 today.
Hazard Analysis and Critical Control Points (HACCP) is a systematic approach to food safety. HACCP is an industry-wide effort designed to improve food safety, especially in retail establishments. The HACCP system deals with a range of existing and potential biological (pathogens), chemical, and physical hazards.
Everyone – from the farmers to the food servers – is responsible for the safety of their food products. Taking a systems approach involves looking at each step of the food handling and preparation process. It is a preventive and proactive maintenance plan rather than a fix-it-when-it-breaks approach. It is essential to be proactive instead of reactive with food safety in order to reduce the chance of food-borne illnesses and protect the quality of food safety products.
The government is very serious about HACCP, and this has caused Americans to become increasingly concerned with food safety as well. Incidences of food-borne illnesses are receiving more and more attention as consumers are becoming more aware of new potentially dangerous food hazards.
The operating principles of the HACCP system can be applied to any food chain activities and to any size business. The seven HACCP principles are:
- Conduct a hazard analysis. Prepare a list of steps in the process where significant hazards occur and describe the preventive measures.
- Identify the Critical Control Points (CCP) in the process.
- Establish critical limits for preventive measures associated with each identified CCP.
- Establish CCP monitoring requirements. Establish procedures for using the results of monitoring to adjust the process and maintain control.
- Establish corrective action to be taken when monitoring indicates that there is a deviation from an established critical limit.
- Establish procedures to verify that the HACCP system is working correctly.
- Establish effective record-keeping procedures that document the HACCP system.
Maintaining proper food safety is essential for every company in the food industry. Companies maintain very strict food safety standards and regulations because if they do not, serious problems may occur.
Without proper regulations in the food manufacturing process, productivity losses and safety issues can occur. The goal is to make a company’s manufacturing process as safe as possible, while being as effective as possible. Productivity losses in the manufacturing plant can cost a business a fortune in lost revenue. However, medical expenses from employees or customers who encounter illness due to lack of food safety standards can be even more costly. Maintaining strict food safety standards upholds the reputation of your business in the eyes of your customers and helps prevent potential hazards from occurring.
At D.L. Newslow & Associates in Orlando, we understand the importance of food safety and can cater food safety training programs to the specific needs of your business. Our team represents over 200 years of experience in combined fields of quality, food safety and system development. Give our main office a call today at 407-290-0252.
At this time in our food chain, there are many reasons why a company may choose to develop, implement, and maintain a system compliant with one of the Global Food Safety Initiative approved, benchmarked approved food safety schemes. Of course, one of the most recent drivers is the pressure being applied by major customers. However, the decision to move forward must be a decision not only because customers or regulators are forcing or encouraging the move, but also because it makes good business sense for the organization. A well-defined, managed, and compliant system adds value and reduces overall costs for the organization.
Actual cost figures are tough to identify. It is difficult to measure the savings of something that did not happen? However, there are enough companies with recalls, incidents, and ruined reputations for management to fill in the blanks, understanding what could happen and might very well happen if the organization does not take control and focus on preventing issues rather than addressing issues after a crisis. In the past, we learned from our mistakes. In modern times, we cannot afford to learn from our mistakes; we must avoid these mistakes by being proactive. The structure and discipline provided by an effective food safety management system does not guarantee food safety, but it absolutely provides the foundation for a proactive process to ensure that many mistakes can be avoided and prevented.
This type of system requires a team effort that is not only supported by top management, but also empowers and trains all associates to understand and play a significant part in food safety every day. Food safety affects everyone; each person has a role no matter what his/her area of responsibility includes.
I thought I would share my new podcast interview with Joe Dagger from APRecs. You can access it via iTunes by clicking HERE. The name of the interview is Food Safety Management Programs and the last time I checked it was #2 in the list. Thanks for listing!
Until next time,
Although this is not really a newsflash since many in our industry have been waiting a long time for the date August 31, 2015. That is the date that FDA committed to release the final regulations of the Food Safety Modernization Act (FSMA). The FDA team spent an unprecedented amount of time researching and reviewing thousands of comments from all realms of the food industry. Even though they took the time to respond to every comment (see final document), FDA was still able to provide a written document by mid-September 2015. Thank you FDA!
This document is critical to the future of food safety and will change it forever. I just wish that my friend and mentor, Jon Porter, who was an important instructor and advocate of food safety was here to see this. He would be pleased with the progress to keep our food supply safe for consumers. As I work with my colleagues, reading and interpreting this document in preparation for our future workshops, consultations and audits, many questions have arisen. Since these questions have come from a variety of sources, we have decided to make our findings and summations available to everyone on our website. Please bookmark this portion of our website to stay up-to-date on the latest developments.
Please keep in mind that there are excellent sources of information available. Our main goal is to review all the regulations and make FSMA more “user friendly” for you to understand and implement. We welcome any additional comments or questions that you may have,please submit them HERE and we will be glad to assist you. Thank you again to each of our supporters and friends. We are all on this journey together! We look forward to being a part of your journey, by assisting you with your operations. On behalf of our entire team, we look forward to your comments, questions, and suggestions.
As of today, here are the top ten questions that we have received and investigated. This is just the beginning since we continue to receive new inquiries every day. We will continue to post on our website the answers to questions that we will continue to receive on this topic. Note: Even though the following questions are numbered, they are not in any order of urgency or concern.
Question 1: What exactly does HARPC mean and how does it fit with HACCP?
Answer 1: HARPC stands for Hazard Analysis and Risk-Based Preventive Controls. Going forward, the HACCP (Hazard Analysis Critical Control Points) Programs will either become part of the HARPC Program or the Food Safety Program. A HACCP Program focuses on controlling a hazard through a CCP or an OPRP (an Operational Prerequisite Program introduced in ISO 22000:2005). The previous sentence needs rewording. How about: Under the Preventive Control Program, preventive controls include either CCPs and/or other preventive controls. The final rule requires a written food safety plan that includes a hazard analysis and preventive controls. Over the years, many operations have felt that they did not need to do a Hazard Analysis if they did not have any CCPs. Such an operation is very likely controlling its hazards through Preventive Controls or as we know them PRPS.
At this time, it seems likely that the term “Food Safety Plan” may replace the HARPC term. However, the main point is to expand the CCP focus on HACCP Programs. Preventive controls relate to key prerequisite programs that most companies have already established. We have been communicating for years that a HACCP program cannot stand-alone. It must be built on a foundation of effective PRPs or it will probably fail.
Stay tuned for Part 2!
Question 2: Are the terms that we currently use, such as HACCP and Prerequisite Programs (PRP), going to go away? Is the term PRPs going to be replaced with Preventive Controls? Are we going to get in trouble by using different terminology?
Answer 2: It isn’t likely that these terms will go away, but will rather be incorporated into each company’s Food Safety Plan. As with any management system, we recommend defining the terminology in a controlled document. Preventive Controls will be congruent to Prerequisite Programs (PRPs) as we know them. Those of us that have a system compliant with a GFSI scheme already have the requirements to ensure that the food safety program is supported (hazards controlled) through effective PRPs. Auditors require that objective evidence (records) is available to verify the effectiveness of each individual PRP.
Stay tuned for Part 3!
Question 3: What will happen to our current HACCP Program? How do I know if it is currently compliant to the Preventive Controls Rule?
Answer 3: The answer to these questions depends on the type of HACCP Program you currently have. We have seen so many different levels of “control” defined in these Programs. Each FDA registered operation must define, implement, and maintain a documented food safety plan that includes the preventive controls that are required to control known or reasonable foreseeable hazards. Control of a hazard translates to either eliminating a hazard or reducing it to an acceptable limit. The rule requires that justification for decisions related to the control of a hazard be based on facts supported by science and risk analysis. The current risk methodology that we have used for years can be applied if it is truly justified by the facts. Risk related to each hazard is considered based on the likelihood of occurrence and the significance of the outcome.
Stay tuned for Part 4!
Question 4: We have a food safety management system compliant with a GFSI benchmarked scheme. Will we need a separate HARPC program?
Answer 4: Again, this question depends on the overall compliance and effectiveness of your system. The benchmarked schemes (FSSC 22000, SQF, IFS, BRC, etc.) do include many of the specifics defined in the FSMA – Preventive Controls. We personally feel that a compliant food safety program that is developed and maintained in compliance with a GFSI benchmarked scheme will be very close to compliant. HOWEVER, I make this statement very carefully, the compliance totally depends on each individual operation’s program and its content. You must not assume that it will definitely be compliant. Each operation must evaluate its program with the FSMA-Preventive Control Rule to identify and effectively address the gaps. An effective food safety management program must be developed, implemented, and maintained in a compliant manner every day, not just in preparation for an annual audit. As with all programs, some are stronger than others. It is up to the management team of each individual operation to ensure that its program “controls” all potential and existing food safety hazards. Keep in mind that FSMA applies in the US only and it is basically more prescriptive then the GFSI benchmarked food safety schemes.
Stay tuned for Part 5!
Question 5: We have not made the decision to establish a food safety management system compliant with an approved GFSI benchmarked scheme. Should we pursue this and, if so, which scheme do you recommend?
Answer 5: This is a tough question. We always recommend that an organization pursue certification. An effective food safety management system provides discipline, structure, and adds overall value to an operation. It also shows due diligence toward FSMA compliance. There are some differences and compliance is not automatic for meeting FSMA requirements. The standard that is best for your operation must be determined by your management team. Overall, depending on the standard of choice, compliance between the elements may be similar. Some standards only apply to a specific food sector and some are more prescriptive. Just know the standard of choice and seek out its fit with FSMA. Do not be afraid to seek assistance.
Stay tuned for Part 6!
Question 6: We didn’t think we needed a HACCP program because our HACCP team determined that we didn’t have any CCPs. Because of this we don’t even have a Hazard Analysis. What do we do now?
Answer 6: Compliance with FSMA- Preventive Controls is now the law. An Organization is required to be registered per FDA’s Bioterrorism Facility Establishment and must develop and implement a documented Food Safety Plan that meets the Preventive Controls rule requirements. It is important that each organization reviews the “exemptions” and the “compliance deadlines” to determine how these may relate to your organization.
Stay tuned for Part 7!