An interview with Fred Hayes, director, technical services, Packaging Machinery Manufacturers Institute.

Q: Food security doesn’t affect just the final product, but also the entire production cycle, including processing and packaging. Which organizations in the U.S. (federal administration, trade organizations, professional associations, trade unions, etc.) are in charge of devising, implementing and monitoring regulations affecting food machinery, equipment and packaging?

A: In the United States, there are two government organizations, created by law, that are responsible for food safety. The U.S. Department of Agriculture (USDA) regulates products such as meat, poultry, egg products, dairy products, etc. The U.S. Food and Drug Administration (FDA)’s scope of responsibility for food products includes basically all food products except those the law assigns to the USDA.

Another Health and Human Services component group, the U.S. Centers for Disease Control and Prevention, collects data and investigates foodborne illnesses (among its other duties).

Alcohol-related products are not considered food products and fall under the jurisdiction of the Bureau of Alcohol, Tobacco, Firearms and Explosives, which is a federal law enforcement agency within the United States Department of Justice.

Q: What are the most recent regulations and the latest standards that have been adopted in the United States relating to machinery to process and package food and for food packaging?

A: In the European Union (EU), machinery must be declared in conformity to the 2006/42/EC machinery directive before it can be placed into service. Section 2.1 of Annex I Essential Health and Safety Requirements, “Foodstuffs Machinery and Machinery for Cosmetics or Pharmaceutical Products,” lists the requirements a machinery supplier must meet using the risk assessment process outlined in Annex I, Section 1, of the machinery directive.

There is no equivalent “law” that requires machinery suppliers in the United States to declare their machine meets a specific law or standard. However, machinery builders and food manufacturers can be held accountable for harm their products may cause under the Restatement Third of Torts law (Products Liability).

Packaging machinery in the United States is covered by the American National Standards Institute (ANSI)/Packaging Machinery Manufacturers Institute (PMMI) B155.1-2011 standard, “Safety Requirements for Packaging Machinery and Packaging-Related Converting Machinery.” This is a voluntary consensus standard that requires the machinery supplier to build the machine to an acceptable level of risk using the risk assessment process. Sanitary design is a consideration in the standard. The ANSI/PMMI B155.1-2011 standard is harmonized with EN/ISO 12100-2010.

Under FDA’s Food Safety Modernization Act (FSMA), all food producers are required to use the risk assessment process to develop production processes, including food production machinery, which will result in the manufacture of safe food products. Therefore, it is up to the food manufacturing companies to purchase equipment from the machinery suppliers that meets the specific sanitary requirements of the food production facility.

Q: Are there common aspects in the regulations established by the EU and by the U.S. government concerning machinery and food packaging?

A: The EU machinery directive and the ANSI/PMMI B155.1-2011 standard both require the machinery supplier [to] perform a documented risk assessment to demonstrate the machine:

(EU) meets the essential health and safety requirements of the machinery directive.

(U.S.) is built to an acceptable level of risk (U.S. ANSI/PMMI B155.1-2011).

Q: Are there any salient differences?

A: In the EU, machinery is covered by the 2006/42/EC machinery directive—a good law, but there’s market surveillance.
In the U.S., packaging machinery is covered by ANSI/PMMI B155.1-2011 standard, which is, as I mentioned before, a voluntary consensus standard. However, market surveillance is very aggressive because of product liability litigation laws. 

Q: What are the main changes that will result with the implementation and enforcement of FSMA for the manufacturers of packaging and processing of food?

A: Food product manufacturers in wet environments, like those found in meat, poultry and dairy plants, have been cleaning processing and packaging machines to a microbiological level for many years. Cleaning to a microbiological level is going to become standard for many dry products, including cereal, crackers, cookies and candy, as well.

This requirement will result in the redesign of processing and packaging machinery. It will also force changes in the layout of equipment in production facilities to reduce the number and types of machinery that must be cleaned to a microbiological level.

Q: What significant issues will the manufacturers of packaging and processing machinery have to deal with in the next three or four years?

A: Machine design is going to involve potential trade-offs such as improving sanitary design while maintaining the ability to change products and clean quickly.

There’s no such thing as a perfect machine. Instead, machine manufacturers will need to work closely with their customers to determine precisely what the end users of their processing and packaging machinery need.