Workshop covers FSMA regulationsby Deborah Jeanne Sergeant

GENEVA, NY — If you process farm goods, understanding the Food Safety Modernization Act (21 CFR Part 117) is vital for both abiding by the law and keeping consumers of your products safe. A federal regulation adopted in 2017 and enacted in late 2018, “FSMA” isn’t as well understood as it should be. Cornell University College of Agriculture and Life Sciences, in cooperation with USDA and National Institute of Food and Agriculture presented “FSMA Regulations for Small and Very Small Food Processors” at the Cornell Food Venture Center recently. The Northeast Center to Advance Food Safety and Cornell AgriTech co-hosted.

Many producers don’t understand which laws apply to them. It depends upon the type of product, how they sell it, and the size of the business, for starters.

“All those things may count and interact with each other,” said Bruno Xavier, Ph.D., senior extension associate and process authority with Cornell Food Venture Center. “Depending upon these factors, you could be under the local health department.”

In general, the local health department regulates food, water and air quality in restaurants, camps, pools, hotels and fairgrounds and in investigating food-borne illness outbreaks.

The Department of Agriculture & Markets covers retail food stores, wholesale food manufacturers other than USDA products and has shared jurisdiction at wholesale points of sale with the FDA. They also cover meat processors not covered under USDA.

The FDA oversees most food, but especially seafood, dairy, shell eggs, juice and acidified and low-acid canned foods.

USDA covers food safety inspection services, along with meat, poultry, egg products and products that contain more than 2% cooked meat or 3% raw meat.

Xavier said most producers fall under the Food & Drug Administration.

FSMA was first introduced in 2011.

“It’s been a long, long process to get it to this point,” Xavier said.

He said inspectors have many facets to look at when inspecting a food processing business.

“It’s not just ‘doing things right,’” Xavier said. “We have to do things to prevent bad things from happening. You can’t make a food and hope it turns out all right.”

He said following the right procedures and documenting each step are foundational for compliance with food safety laws. Relying on memory or common sense isn’t enough.

“We must assume if you didn’t write it down, it didn’t happen,” Xavier said.

He broke down the steps of FSMA compliance:

  1. Identify hazard
  2. Understand cause
  3. Implement prevention controls
  4. Monitor effectiveness
  5. Review and adjust

“This is how to think about food safety,” Xavier said. “Talk with people who know about food safety to identify the hazards.”

The processor should repeat the steps every two to three years.

Xavier defined food safety as “Programs or activities for handling, preparing and storing food to prevent illness or injury when eating food.”

No one anticipates becoming ill when preparing to eat food. Consumers rightfully expect their food to be safe to eat. When it’s not, that can really make it difficult, both for affected consumers and for the processors trying to do business.

“That’s a level of trust we have for consumers,” Xavier said. “We don’t want a bottleneck for the success of the business.”

That’s what happens when a food processor experiences a recall because of tainted ingredient or final product, for example.

Xavier said hazards are “a biological, chemical or physical property that may cause illness or injury when consumed.”

An example of a biological hazard includes bacteria contaminating the product.

Physical hazards may be an object that falls into the food, such as a part that has broken off equipment, bones from the meat or pieces of pits or shells.

Chemical hazards could include actual chemicals, such as cleaning supplies, pesticides or unapproved additives tainting a batch. They may also include, or allergens that are not listed on the label, like cross-contamination of peanuts in a product that is not supposed to contain peanuts.

“This is extremely serious,” Xavier said.

Some food allergies can be fatal, such as peanut allergy, which can cause anaphylactic shock. He said according to the FDA, every year, food allergies cause 30,000 emergency room visits, 2,000 hospitalizations and 150 deaths “that are totally preventable. It’s not easy. There’s no cure for food allergies, but just treatments to minimize the response.”

In food processing, cross-contamination and mislabeling are two big reasons food allergens affect unsuspecting consumers.

Xavier warned processors who receive ingredients from countries with different food labeling laws. For instance, some don’t require declaring tree nuts.

“Talk with your supplier,” he said.

Biologic hazards are what many people think about when it comes to food safety. Microorganisms can contaminate food, but they also enable our survival and contribute to the making of some favorite foods, like yogurt and pickles.

Some microorganisms cause spoilage in food, but don’t cause disease, like yeast, mold and most bacteria.

And, yes, some microorganisms cause disease. These biologic hazards or pathogens don’t benefit people. Xavier said about 48 million cases of foodborne disease occur in the U.S. annually, affecting about one in six people.

“Quality of life is compromised,” Xavier said. “People miss work and school.”

More serious outcomes include 128,000 hospitalizations and 3,000 deaths.

“You can go to jail if you get a lot of people sick and the FDA comes in and says, ‘We told you what to do and you didn’t comply,’” Xavier said.

Foodborne infections differ from foodborne intoxications. Infections are caused by consumption of food containing pathogens. The food serves as a carrier of the microorganisms.

Intoxications are caused by consumption of food containing the toxins produced by microorganisms. Toxins cause the illness, not the microorganisms.

Producers also need to understand that the classification of the food they make will help determine their regulations: acid food (formulated), acidified foods, water activity controlled, low acid, fermented acid, shelf stable, refrigerated, frozen or perishable.

“Depending upon your classification, you may be exempt from certain regulations,” Xavier said.

Home processing non-hazardous foods may qualify for a NYSDAM exemption. Exempt items include standard jams, jellies and marmalades. Adding offbeat ingredients that change the acidity, such as avocado jelly, would not be exempt.

Other items include baked items, double crust fruit type pies, cakes that require no refrigeration, dried pastas, candy (but not chocolate), dried spices or herbs that aren’t dehydrated, and snacks like popcorn and peanut brittle.

Xavier emphasized the factors for pathogen growth as “FATTOM”: Food (nutrient source for microbes), Acidity (microbes prefer neutral acidity to high acid), Temperature (they grow best between 70 and 120 degrees), Time (longer time in the temperature danger zone means more organisms growing in the product, Oxygen (some organisms require oxygen for growth; others prefer no oxygen) and Moisture (available water for microbial growth).

Since acids can inhibit or even kill some microorganisms, it’s vital to know the “dividing line for acid and low acid foods.”

“Foods that have a natural pH below 4.6 include most fruits, like apples, berries, peaches and grapes, mayonnaise and sauces that are mostly acidic ingredients,” Xavier said. “A small fraction of low acid ingredients is acceptable.”

Those above 4.6 include meat, vegetables, milk, soups, and nut milks. Certain conditions can even increase risk.

Shelf stable items are low acid foods to which acid is added to achieve pH that’s 4.6 or lower.

Fermented acid foods like sauerkraut, kimchi, kombutcha and yogurt are inspected by the NYSDAM.

“Low sodium items are challenging because the salt helps the good microbes beat the ‘bad’ pathogens,” Xavier said.

Using heat while processing can also keep food safer and last longer. Low-acid foods with water activity need two minutes of heat at 250 degrees F and high acid foods need 180 degrees F for five minutes to make shelf stable.

Xavier stressed that proper refrigeration also helps small-scale processors keep foods fresher and safe.

“No microbial growth occurs below zero degrees F,” Xavier said.

Regardless of the processing method, following the FSMA laws and documenting the procedures keeps both processors and consumers safer.