How to Build Food Safety Into R&D

Food laws around the world mandate that foods, beverages, and ingredients manufactured and sold by food processors must be safe. Failure to do so may result in people becoming ill or dying, damage such as lost sales and reputation to the operation that produced the food, and even closure of the business. A foodborne outbreak also may have peripheral effects. The outbreak attributed to E. coli O157:H7 in raw spinach in 2001 adversely affected sales of frozen spinach, blanched spinach, and other items such as spinach quiches and raviolis. A similar trend occurred with hamburger chains after the Jack-in-the-Box outbreak in 1993. The Salmonella outbreaks associated with nuts and nut butters put the Peanut Corporation of America and Sunland out of business.

Essentially, the mantra is this: Do it right from the beginning and at all times. This means that food companies must make sure that food safety is built into the process during the product development phase, ensuring that safety and quality protocols are established, including adhering to and properly documenting validated processes and maintaining and monitoring all best practices. Development and implementation of these programs to ensure food safety is part of what is expected from the research and development (R&D) team.

The R&D team, which is charged with developing new products, creating line extensions, and modifying existing formulations, must be properly trained in food safety principles, specifically Hazard Analysis and Critical Control Points (HACCP) principles. This applies whether the product development is done in-house or through an outside product development firm. In fact, companies that have in-house development teams must be sure that at least one member of their R&D group is a member of the company’s HACCP team. The HACCP training that the team receives should include examples utilizing products that resemble what that company produces. And, of course, these educational programs must be documented for each person.

Food Safety Step-by-Step

Product development is a multistage process, which includes ideation, development, pilot testing, and commercialization/rollout. It is a well-known fact that new product development and introduction of new products is a challenge. For every new product that succeeds, there are many failures. Some failures may be traced to a failure of market research. Look at what happened to companies that jumped on the no carb/low carb bandwagon a few years back. What seemed to be a new trend was nothing of the sort.

In most companies, the marketing and sales teams are the ones who come up with new ideas and take them to the in-house R&D team or to a contracted third-party product development group. One step that should be part of every company’s new product development program is to have the concept evaluated by a group from within the company under their change management procedure. The role of change management is to look at the pros and cons of every potential change—that is, new ingredients or sources, different equipment, modified or altered production procedures or workflow needed to produce the new product, for example—to determine whether the proposed changes are feasible and to establish whether there are potential quality or safety risks. If the team determines that a new idea is high risk for food safety, the idea will probably be dropped, or they will need to rethink the concept.

The marketing team tends to want to see ideas come to fruition very quickly, so it is up to the R&D group to lay out the potential challenges, development concerns, and food safety issues and to present realistic timelines to complete the project. Timelines will depend upon the type of product and the process that is proposed. In addition, consideration must be given to how and where the product will be manufactured. Will it be produced in a wholly owned facility of the company, or will it be co-packed? A low-acid or acidified canned food would entail more work than a line extension for a carbonated beverage. Companies looking at one of the nonthermal processing options such as high pressure processing or pulsed light may have longer timelines since these are relatively new processes and their application is still rather limited. But even development of new products using old technologies such as canning may be a long, drawn-out process, especially if the item is unique or utilizes a new package. The new concept may require thermal death time studies or even a challenge study using a surrogate organism such as a nontoxic Clostridium strain.

There are many products that are heat processed. These include canned foods, fried foods, bakery items, nuts, spices and beverages of all types. With the enactment of the Food Safety Modernization Act (FSMA), there has been a greater emphasis within the industry to properly validate all manner of thermal processes. As an example, for many years, food processors producing baked and fried foods assumed that these products were safe. FSMA changed that. Processors evaluated their traditional processes. In most cases, they discovered that they effectively eliminated potential pathogens. The exception was bakery items with inclusions such as nuts, large grains, and dried fruit. The batter portion heated properly, but the inclusions were found to heat up at a slightly lower rate. FSMA ensured that this was addressed in company HACCP plans by mandating that the inclusions are pathogen-free, which was achieved through formulation or processing by the supplier. The critical control points for such products were now the supplier’s process and supporting certificate of analysis and the baking time and temperature in their operations.

One example of how industry has evolved to meet buyer demands for safe ingredients is the almond industry in California. Salmonella outbreaks in 2001 and 2004 prompted the industry to establish programs to ensure that raw almonds were properly processed. The Almond Board of California (ABC) developed the program and administers it today. ABC has established protocols to approve specific processing systems, validate processes, and evaluate and approve process authorities. So, it is up to the R&D team to develop the processes required to ensure that each new item can be produced safely.

Ingredients for Success

Another element of the development process is to determine what ingredients will go into the new product. Can the product be produced using ingredients that are already included in the company’s supply chain? Will the new product include one of the Big Nine allergens according to United States regulations or one of the 14 allergens identified by the European Union if the product or products will be sold in Europe? Whatever ingredients are selected for the new product, it is up to the R&D team to conduct a risk assessment of each ingredient and for the final product.

There is an excellent tool available to the food industry in the U.S. Food and Drug Administration’s guidance document, Hazard Analysis and Risk-Based Preventive Controls for Human Foods: Guidance for Industry (FDA 2024). This document breaks foods and food ingredients into the following 13 categories:

1. Bakery
2. Beverage
3. Chocolate and Candy
4. Dairy
5. Dressings and Condiments
6. Egg
7. Food Additives
8. Fruits and Vegetables
9. Game Meat
10. Grains
11. Multi-Component Foods
12. Nuts
13. Oils

There are three sections in the document that look at microbiological, chemical, and process-based hazards for each of these product groupings. Companies may use this as is or conduct their own risk assessments. Some operations utilize this document as an integral element of their risk assessment programs but go one step more. If their assessment differs from the document, they incorporate a documented risk assessment that defines why their assessment differs.

The selection of ingredients depends upon the product being developed, company policies and procedures, and availability of ingredients. If an ingredient needed for the new product is already being used elsewhere, it makes life easier for the development team and the purchasing group. If it is a new ingredient from a new supplier, that specific ingredient, the company supplying the ingredient, and the specific facility producing the material must be subjected to the company’s vendor approval program. Supplier approval should always be plant-specific, which ultimately puts a burden on whomever ends up manufacturing the new product. The warehouse team responsible for receiving ingredients and raw materials must be sure that the ingredient is not only the proper ingredient but from the approved processing facility. Processors have had to initiate recalls because an unapproved facility operated by an approved supplier shipped product.

The R&D team also must be aware of in-house policies. There are some companies that operate “peanut-free” facilities. This means that a new product destined for production in that facility cannot use peanuts in the formulation. Whether to formulate with allergen-containing ingredients is a decision that product developers must make. Products formulated with allergens create a potential risk in the production facility, especially if the operation has not had to deal with allergens in the past. On the other hand, many of the foods that are allergens are acknowledged as healthy ingredients. Examples are soy and tree nuts.

Pilot Studies, Scale Up, and Rollout

During the development stage, the R&D team will interact with the marketing group and perhaps the public, using focus groups to evaluate how the items are perceived. Now, we have another food safety issue that companies with pilot facilities have had to address. If a company uses their pilot facility to manufacture products for human consumption, that facility must be treated as a food processing facility. The pilot plant team must understand food safety protocols and HACCP to ensure that the foods produced are safe. Pilot plants are subject to audits by regulators and many companies engage a third-party auditing firm to audit the pilot facility as if it is a food manufacturing plant.

It is at the pilot level where processors can first determine whether a food or beverage product developed on the bench can be scaled up for production. This is also the point at which an operation can conduct initial trials to establish thermal processes. The importance of this step is to validate the processes, especially the thermal processes, as this serves as a kill step for all products, whether they are canned low-acid foods, baked goods, fried foods, or a hot-fill beverage. If a company utilizes a third party for product development, they should make sure that the contractor selected has the expertise to handle the scale up. There are instances in which the move from the bench to production did not go smoothly, delaying the commercial rollout.

Food Safety First

Ultimately, the goal is not only a new product that sells well and delights consumer palates but is a safe, high-quality product. Each step in the process includes programs to identify and address potential hazards, whether they are biological, chemical, or physical. This takes a dedicated and educated staff and management who are committed to doing things right up front and throughout the product development and production process, providing the team with the tools and support to successfully build in food safety from the get-go.ft