Artificial intelligence and real-world data for drug and food safety - A regulatory science perspective.

In 2013, the Global Coalition for Regulatory Science Research (GCRSR) was established with members from over ten countries (www.gcrsr.net). One of the main objectives of GCRSR is to facilitate communication among global regulators on the rise of new technologies with regulatory applications through the annual conference Global Summit on Regulatory Science (GSRS). The 11th annual GSRS conference (GSRS21) focused on "Regulatory Sciences for Food/Drug Safety with Real-World Data (RWD) and Artificial Intelligence (AI)." The conference discussed current advancements in both AI and RWD approaches with a specific emphasis on how they impact regulatory sciences and how regulatory agencies across the globe are pursuing the adaptation and oversight of these technologies. There were presentations from Brazil, Canada, India, Italy, Japan, Germany, Switzerland, Singapore, the United Kingdom, and the United States. These presentations highlighted how various agencies are moving forward with these technologies by either improving the agencies' operation and/or preparing regulatory mechanisms to approve the products containing these innovations. To increase the content and discussion, the GSRS21 hosted two debate sessions on the question of "Is Regulatory Science Ready for AI?" and a workshop to showcase the analytical data tools that global regulatory agencies have been using and/or plan to apply to regulatory science. Several key topics were highlighted and discussed during the conference, such as the capabilities of AI and RWD to assist regulatory science policies for drug and food safety, the readiness of AI and data science to provide solutions for regulatory science. Discussions highlighted the need for a constant effort to evaluate emerging technologies for fit-for-purpose regulatory applications. The annual GSRS conferences offer a unique platform to facilitate discussion and collaboration across regulatory agencies, modernizing regulatory approaches, and harmonizing efforts.

Applications and Perceptions of Date Labeling of Food.

Open dating of food products has been practiced for decades, and has been key to achieving stock rotation at retail and providing information to consumers. The open date provides a simple communication tool, which may be based on product quality and/or food safety as determined by the manufacturer or retailer. Date marking is generally open but it can be closed (code intended for managing product at retail, and for recall and traceability), and the terminology and applications vary widely around the world. The variation in date labeling terms and uses contributes to substantial misunderstanding by industry and consumers and leads to significant unnecessary food loss and waste, misapplication of limited resources, unnecessary financial burden for the consumer and the food industry, and may also lead to potential food safety risk in regards to perishable foods. A "use by" or similar date cannot be relied on to indicate or guarantee food safety because absolute temperature control of food products throughout the food supply chain cannot be assured. This paper provides an introduction to the issue of food product date labeling and addresses its history in the United States, different terms used and various practices, U.S. and international frameworks, quality compared with safety, adverse impacts of misconceptions about date labeling, and advantages of technological innovations. Collaboration to develop a simple workable solution to address the challenges faced by stakeholders would have tremendous benefit. Conclusions include a call to action to move toward uniformity in date labeling, thereby decreasing confusion among stakeholders and reducing food waste.

Impact of the Global Food Safety Initiative on Food Safety Worldwide: Statistical Analysis of a Survey of International Food Processors.

In 2000, the Consumer Goods Forum established the Global Food Safety Initiative (GFSI) to increase the safety of the world's food supply and to harmonize food safety regulations worldwide. In 2013, a university research team in conjunction with Diversey Consulting (Sealed Air), the Consumer Goods Forum, and officers of GFSI solicited input from more than 15,000 GFSI-certified food producers worldwide to determine whether GFSI certification had lived up to these expectations. A total of 828 usable questionnaires were analyzed, representing about 2,300 food manufacturing facilities and food suppliers in 21 countries, mainly across Western Europe, Australia, New Zealand, and North America. Nearly 90% of these certified suppliers perceived GFSI as being beneficial for addressing their food safety concerns, and respondents were eight times more likely to repeat the certification process knowing what it entailed. Nearly three-quarters (74%) of these food manufacturers would choose to go through the certification process again even if certification were not required by one of their current retail customers. Important drivers for becoming GFSI certified included continuing to do business with an existing customer, starting to do business with new customer, reducing the number of third-party food safety audits, and continuing improvement of their food safety program. Although 50% or fewer respondents stated that they saw actual increases in sales, customers, suppliers, or employees, significantly more companies agreed than disagreed that there was an increase in these key performance indicators in the year following GFSI certification. A majority of respondents (81%) agreed that there was a substantial investment in staff time since certification, and 50% agreed there was a significant capital investment. This survey is the largest and most representative of global food manufacturers conducted to date.

Companies' opinions and acceptance of global food safety initiative benchmarks after implementation.

International attention has been focused on minimizing costs that may unnecessarily raise food prices. One important aspect to consider is the redundant and overlapping costs of food safety audits. The Global Food Safety Initiative (GFSI) has devised benchmarked schemes based on existing international food safety standards for use as a unifying standard accepted by many retailers. The present study was conducted to evaluate the impact of the decision made by Walmart Stores (Bentonville, AR) to require their suppliers to become GFSI compliant. An online survey of 174 retail suppliers was conducted to assess food suppliers' opinions of this requirement and the benefits suppliers realized when they transitioned from their previous food safety systems. The most common reason for becoming GFSI compliant was to meet customers' requirements; thus, supplier implementation of the GFSI standards was not entirely voluntary. Other reasons given for compliance were enhancing food safety and remaining competitive. About 54 % of food processing plants using GFSI benchmarked schemes followed the guidelines of Safe Quality Food 2000 and 37 % followed those of the British Retail Consortium. At the supplier level, 58 % followed Safe Quality Food 2000 and 31 % followed the British Retail Consortium. Respondents reported that the certification process took about 10 months. The most common reason for selecting a certain GFSI benchmarked scheme was because it was widely accepted by customers (retailers). Four other common reasons were (i) the standard has a good reputation in the industry, (ii) the standard was recommended by others, (iii) the standard is most often used in the industry, and (iv) the standard was required by one of their customers. Most suppliers agreed that increased safety of their products was required to comply with GFSI benchmarked schemes. They also agreed that the GFSI required a more carefully documented food safety management system, which often required improved company food safety practices and increased employee training. Adoption of a GFSI benchmarked scheme resulted in fewer audits, i.e., one less per year. An educational opportunity exists to acquaint retailers and suppliers worldwide with the benefits of having an internationally recognized certification program such as that recognized by the GFSI.