Category: Prerequisite Program

Food Allergy Tips – Protect your Customers and Your Business

Food allergies are a major factor in the lives of millions of Americans. Allergic reactions range from minor discomfort to full anaphylaxis. There are over 170 foods that have been identified as causing allergic reactions, but the majority of reactions come from the Big Nine: milk, eggs, nuts, fish, crustaceans, shellfish, wheat, soy and sesame. For many years, there were only eight major allergens identified by the FDA. Sesame was added to the list on January 1, 2023. If any of these nine allergens is in a product, even in trace amounts, it must, by federal law, be identified on the food label. In this blog post, we’ll cover why it’s important to protect consumers and your business with allergen labeling, the hidden spots where allergens may be found, and the food safety practices you can implement to protect people with allergies.  Why label allergens? Though allergens are only dangerous to the person sensitive to the allergen, for those people they can be deadly. The only way allergy sufferers can be safe is to avoid their triggers. Clear product labels help allergy sufferers find which foods they can consume safely. One of the main ways food manufacturers keep people with allergies safe is through allergen labeling. The FDA’s Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 established the original eight food allergens with the requirement that they must be identified on food labels.  When food allergens are on a food label, it’s easier for individuals with food allergies and their caregivers to identify which foods are safe to eat. Thus, labeling creates consumer trust and allows people with allergies to live with less fear of accidentally consuming the allergen. However, a third of FDA food recalls are due to allergens not listed on the label. Labeling allergens is particularly valuable in instances where the allergen is a minor component of an ingredient or may not be expected in the product. For example, milk may be present in chocolate chips. Sesame can be present in granola or crackers. And, you might find eggs in soups or soup mixes. Creating An Allergen-Aware Food Safety Program If you produce a product that contains a food allergen, especially one of the Big Nine, it’s imperative that your food safety plans and practices include protocols for managing allergens in your facility and production process.  You need an allergen control program which includes specific Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOPs) for every step of the production process involving allergens. Make sure to include: Allergens frequently get into food through cross contact with equipment, the movement of individuals throughout your facility, and the flow of air in your space. Airborne allergens are a real risk. It may be worthwhile to ban certain allergens from your facility if you are making an allergen-free product.  The risk of mislabeling allergens or having an unlabeled product is two-fold. You could cause harm to a person with an allergy and you could cause harm to your business. Mislabeled or unlabeled foods will need to be recalled and can lead to a loss of consumer trust; both of which  could put a small food business out of business.  The best way to support your consumers with food allergies and prevent a costly recall is to have a comprehensive allergen policy. If your allergen policy needs a refresh to account for sesame or you never had one to start with, schedule a free consultation to get the process started. 

Start with the FDA Good Manufacturing Practices to Build a Strong Food Safety Plan

Having a good food safety program is key to food business success. Yet, it’s hard to know where to start with creating your plans and documents. The FDA’s Good Manufacturing Practices (GMPs) are a set of standards that regulate food safety. They serve as a model for creating a successful food safety plan.  The GMPs are not comprehensive, but they identify key risks that may exist in your process and show how you and your team can control them.  Beyond their value in shaping food safety plans, GMPs are regulated and inspected by the FDA. Even if you are a small producer, the FDA can inspect you on your GMPs. Therefore, it’s extra important that your food safety processes are in compliance. The GMPs contain five main areas of focus. In this blog post, we will discuss those areas and their importance, and share the value of GMPs for your food safety plan overall.  Good Manufacturing Practices 5 Areas of Focus The FDA has organized the Good Manufacturing Practices into five areas of focus. These areas each address a part of the food production and storage process. The overall goal of the GMPs is to keep hazards out of the finished product.  Designing a food safety plan that addresses each of these areas of focus will ensure you are adhering to the GMPs. It will also guarantee that you are keeping your product as food safe as possible. These are the five areas of focus covered in the FDA GMPs: 1. General Provisions  This section outlines the expectations for people who produce the food. It outlines the responsibilities of the business owners and management regarding when people can be allowed to work after illness. It also details personal hygiene requirements and the expectations around food safety training.  Example from the GMP regulations: Personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe food 2. Buildings and Facilities This section contains requirements for the physical space where the food is produced. It includes expectations around the layout, facilities, and cleaning practices necessary to ensure a safe environment.  Example from the GMP regulations: The plant and facilities shall: Be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact.  3. Equipment  This section explains the expectations around keeping equipment safe and sanitary. In particular, it covers controls for regulating temperatures and notifying employees if they fluctuate too much.  Example from the GMP regulations: Seams on food-contact surfaces shall be smoothly bonded or maintained to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms. 4. Production and Process Controls This section discusses the sanitation processes that need to be in place to keep food safe. It also covers how to prevent contamination during post-production storage and distribution.  Example from the GMP regulations: Raw materials, other ingredients, and rework shall be held in bulk, or in containers designed and constructed to protect against contamination and shall be held at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated within the meaning of the act.  5. Defect Action Levels  This section acknowledges that sometimes foods that are produced safely still contain low levels of natural or unavoidable defects that are not hazardous to health. It defines the maximum allowed levels of defects such as insects, rodent filth, and mold. The FDA still expects these levels to be as low as possible and provides guidance on how to manage them.  Example from the GMP regulations: The mixing of a food containing defects above the current defect action level with another lot of food is not permitted and renders the final food adulterated within the meaning of the act, regardless of the defect level of the final food. Together, these focus areas show how to safely operate a food safe production facility. For more information about the specifics contained within each of the focus areas, refer to this FDA resource.  Why the Good Manufacturing Practices are Valuable The Good Manufacturing Practices are an invaluable tool for food safety, both for new processors and existing food facilities.  If you are just starting to produce at scale, the GMPs are a great template for creating a food safety plan. Make sure you cover all the areas discussed above to give you a strong, comprehensive food safety plan.  If you have an SOP that documents how you will carry out each process, you will be in compliance with the regulations. In particular, the GMPs are valuable because they cover personnel requirements and detail what to do in the case of bacteria cross contamination and allergen cross contact. Most bacterial and viral food contamination is caused by the people making the food. The GMP guidance on personal health and hygiene, and instructions on behavior help you control that risk.  Cross contact is a big issue for allergens. Nearly a third of food recalls are because an allergen was not listed on the label. The GMPs clearly outline how to prevent cross contact between allergens and what to do if an allergen gets into a food. If you can catch this before the allergen ends up in the final product, you save on the cost of having a recall due to misbranding and you protect your consumer.  It’s important to show buyers and auditors you are continually improving your food safety program. Thus, even established businesses with great

Quality Assurance and Quality Control

Quality assurance and quality control are essential functions in a food business as they ensure that products that meet company specifications reach the customer. Read my latest blog post that explains what functions of a QA/.QC program and the advantages of having a QA/QC program. Small food businesses still need to carry out these functions and may use consultants to fulfill the role of a QA/QC manager. Enjoy!

Using FDA Guidance Documents to Help You Write Your Good Manufacturing Practices and Policies

When writing Good Manufacturing Practises, my first stop is to check out the FDA’s guidance documents. These documents provide helpful advice as, while they not legally binding, they explain FDA’s current thinking on a topic to do with food regulations or dietary supplements. Specific regulatory or statutory requirements are cited within the documents. The topics covered by different documents span from food safety to food labelling, from milk guidance to medical foods, there is a wealth of information on current thinking there. For example, there is a draft guidance for the “Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” which gives recommendations to covered farms on the thought of current practices for produce. The topics covered in this guidance document include how to tell if your farm is a covered farm, hygiene practices,  recommendations on practices for safe growing, harvesting, packing, and holding activities on your farm etc.  Once you have decided on the topic of the particular GMP you need to write, you can start your draft using language from the relevant guidance document. There may be another way to do the GMP you are writing about. However, be prepared to defend its effectiveness if you are not following FDA’s recommendations. Especially if it is part of your food safety system to reduce pathogens. Some Tips: MUST means that this part of your policy will always happen; usually because it is in the regulations. In your own GMPs you can decide that something has to happen that isn’t required by law and it becomes a MUST statement. For example, the farmer MUST provide handwashing facilities at all field sites. Should means that something is recommended, but not required by the regulations. For example, farms that do not fit the category of covered farm, SHOULD still follow federal regulations and have a prerequisite program in place. Including means options that are not limited to the described items. For example, processing methods that are approved to treat produce after harvest that reduce the growth of pathogenic bacteria INCLUDE making jams and jellies, cooling freezing, adding acid and heating. Once you have written a GMP, you must write a Standard Operating Procedure for each key step especially if records are necessary to verify that the procedure took place. You must also have a system in place where someone else further verifies that the procedure was carried out as described by the SOPS. My personal policy is that, at a minimum, you want an SOP for every form that must be completed.  I gave details on writing SOPS here. Do you have GMPS? Not sure they are satisfactory? Finding the language used hard to follow? Consider attending my Food Safety Coaching Workshop in Philadelphia on Aug 22.