April 7, 2015 was World Health Day--an annual event established by the World Health Organization (WHO) to draw attention to a topic of global significance. This year, the day was dedicated to food safety. In selecting this year’s focus, Dr. Margaret Chan, Director-General of WHO, cited the need to “catalyze action to put measures in place that will improve safety of food throughout the food chain from production to consumption”.[1] She went on to note that “food can become contaminated at any point of production and distribution, and the primary responsibility lies with food producers”.

Efforts to minimize the risk of contamination are essential as a single event can have widespread impact. Consider just two recent examples. The 2011 Escherichia coli outbreak--linked to contaminated sprouts--originated in Germany and led to cases in eight countries in Europe and North America and 53 deaths. This outbreak resulted in $1.3 billion in losses for farmers and industries and $236 million in emergency aid payments to 22 European Union (EU) member states.

That same year, a farm in Colorado voluntarily recalled shipments of cantaloupe due to concerns of Listeria contamination. The cantaloupes had been shipped to 17 states and were later blamed for the deaths of at least 33 and sickening another 147--one of the country’s most deadly outbreaks of foodborne illness. [2]

Foodborne illnesses are a threat to public health and the economy. New data from the U.S. Department of Agriculture (USDA) estimates that foodborne illnesses cost the economy more than $15.6 billion annually.[3] According to the Centers for Disease Control (CDC) approximately 48 million people suffer from foodborne illness per year, resulting in about 128,000 hospitalizations and 3,000 deaths.[4] In the EU, 320,000 cases of foodborne illness are documented each year, although the real number is likely much higher due to under-reporting.[5]

Improving the safety of our food continues to be a major focus for producers and manufacturers. The global market for food safety is expected to reach $16 billion by 2020, driven by increased worldwide demand for safer food, availability of new, rapid testing methods, and increased government regulations.[6] The number of microbiology tests performed in the food industry each year is more than one and a half times that of the highly regulated pharmaceutical industry (1.3 billion compared to 800,000), with a higher compound annual growth rate (5.8% compared to 4.5%).[7]

For years, EMD Millipore has partnered with customers in the food and beverage industries to address these pressing challenges, helping to improve safety and minimize risk to consumers while reducing costs. With so many points of exposure, we must enable customers to remain vigilant from the earliest stages of processing through to manufacturing and product release with solutions for indicator organism testing, pathogen testing, beverage spoilage and environmental monitoring. 

Environmental monitoring is used to determine the microbial and particulate content of air, compressed gases, surfaces and personnel. Identifying and addressing contamination in food production is critical since it can damage product, lead to recall, delay time to market and compromise consumer safety. Thus, environmental monitoring is an essential component of any quality control program.

During routine inspections at an nSpired Natural Foods facility in February and July 2014, the U.S. Food and Drug Administration (FDA) isolated Salmonella from environmental samples.[8] In August, the food manufacturer recalled lots of almond and peanut butters due to potential contamination. The recall was not in time as six people were identified as being infected with the outbreak strain from five states during the January to May timeframe.

Despite the critical role of environmental monitoring, the focus of regulatory bodies has historically been on end product testing. This is changing, however. Updates to the 2011 U.S. FDA Food Safety and Modernization Act (FSMA) are expected to be finalized in early 2015 and will include “preventive controls” that require, when appropriate, food producers to test products and the facility’s environment.

A number of standards encompass environmental monitoring such as Hazard Analysis and Critical Control Points (HACCP) and ISO 22000. These standards, however, are nonprescriptive and only describe guidelines for food safety management systems; they do not define what specific actions an organization must take to meet these requirements.

As such, it is left to each company to define their own food safety and hygiene system. To ensure the highest level of product quality and protect consumers, manufacturers and producers should establish best practices for environmental monitoring. Procedures for implementation and frequency of surface, air, personnel and compressed gas testing should be included, as well as documentation, standard operating procedures and training. Existing standards such as HACCP should be used to identify control points and critical control points.

A number of factors should be considered when defining the risk level and the best approach to environmental monitoring. Production zones with the highest risk should be subjected to a more stringent environmental monitoring regime and higher sampling frequency. Zones with higher risk include surfaces that come in contact with the final product, high personnel traffic areas and points in the manufacturing process close to the final filling area, production line or packaging surface.

In addition to where and how often testing is conducted, producers and manufacturers must also consider the overall risk of their products when formulating environmental monitoring programs. Risk is related to the type of product, whether it supports growth of pathogens during storage and the type of contamination that is likely.

The intended use or how the food is to be eaten also determines risk. “Ready-to-eat” products are effectively high risk compared to foods that are always cooked prior to consumption. The extent of product processing also impacts the possible risk to consumers. Properly heat-processed foods should be free of pathogens. However, if heat processing does not happen during final packaging, the product can become cross-contaminated during slicing or cutting and packaging. 

Additionally, the potential risk to consumers is higher among groups such as infants and the elderly, who are especially vulnerable to pathogens. In these instances, environmental monitoring is necessary to confirm that the risk of contamination is low.

The expectation that food producers and manufacturers do everything possible to ensure safety from “farm to fork” is clear. Among our customers, we have witnessed an increased demand for environmental monitoring solutions. It is evident that a more intense focus is being placed on establishing a clean and safe production environment.

When celebrating this year’s World Health Day, it is important to remember that the industry bears a great responsibility to reduce the risk to consumers, around the globe and on a daily basis. Comprehensive environmental monitoring programs in combination with final product testing are necessary to realize this goal and consistently provide safe, high-quality products.

John Sweeney is the head of lab solutions business at EMD Millipore. He can be contacted directly at john.sweeney@emdmillipore.comDamien Tuleu is the head of biomonitoring business field at EMD Millipore.


1. http://www.who.int/foodsafety/en/.

2. http://www.fda.gov/Safety/Recalls/ucm271879.htm.

3. Flynn, Dan. “USDA: U.S. Foodborne Illnesses Cost More Than $15.6 Billion Annually.” Food Safety News. Retrieved February 2, 2015, from http://www.foodsafetynews.com/2014/10/foodborne-illnesses-cost-usa-15-6-billion-annually/#.VM-rRmjF-Ag.

4. Centers for Disease Control and Prevention (2012). CDC Estimates of Foodborne Illness in the United States. Retrieved November 20, 2012, from http://www.cdc.gov/foodborneburden/2011-foodborne-estimates.html.

5. European Food Safety Authority. The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2013, EFSA Journal 2015; 13 (1): 3991, http://www.efsa.europa.eu/en/efsajournal/pub/4036.htm. http://www.efsa.europa.eu/en/topics/topic/foodbornezoonoticdiseases.htm.

6. http://www.prweb.com/releases/food_safety_testing/mycotoxin_testing_market/prweb12324253.htm.

7. Industrial Microbiology Market Review, Fourth Edition: Global Review of Microbiology Testing in the Industrial Market (IMMR—4)

8. Multistate Outbreak of Salmonella Braenderup Infections Linked to Nut Butter Manufactured by nSpired Natural Foods, Inc. Center for Disease Control and Prevention. October 16, 2014. Web Dec. 2014 <http://www.cdc.gov/salmonella/braenderup-08-14/>