Later this year, food processing and manufacturing companies are going to have final rules from Washington, D.C., for food safety. How ready they are to face those requirements under 2011 laws could depend on how much work they've put into improving food safety during the past two years.
The Food Safety Modernization Act, or FSMA, came on the heels of high-profile cases of food-borne illness in over the past decade and had broad industry backing to improve safety measures, inspections and the traceability of food sources.
The law also gave the U.S. Food and Drug Administration new recall powers and oversight of food production categories formerly not scrutinized the same as meats and seafood.
Large and medium food companies, as well as food entrepreneurs, all are supportive of increased food safety. But some people worry about the traceability regulations, the complexity of varied monitoring standards and what compliance will cost the industry.
"There will be a number of smaller companies across the state and country that will struggle with this and will see this as a significant economic burden," said Wendie DiMatteo Holsinger, president and CEO of Lebanon County-based ASK Foods Inc., a maker of all-natural prepackaged meals.
ASK, which employs about 250 people, won't have trouble meeting FSMA regulations — expected this fall after comment periods end in September — mainly because the company has been certified under the Safe Quality Foods standards to do business in Europe for several years, DiMatteo Holsinger said.
However, meeting those standards, which are stricter than FSMA, has cost ASK 30 percent more in its procedures over the past three years, she said.
"We're in the group that's probably more prepared," she said.
The most immediate changes associated with FSMA include assessing food safety risks and controlling or minimizing those hazards through a system known as Hazard Analysis and Risk-Based Preventative Controls, according to FDA.
That protocol is similar to Hazard Analysis and Critical Control Points, or HACCP, said Alan McConnell, director of the Food Science & Technology Center at Harrisburg University of Science and Technology.
The meat and poultry industry have used HACCP since 1994, he said. Later, the juice and seafood industries were added. Under FSMA, candy manufacturers, fruit and vegetable producers, packers, bakers and food processors also will be required to adhere to the protocols.
"That's a big change," McConnell said.
It could cost the industry more than $470 million, he said. The added costs will be a struggle for very small companies, but it's not insurmountable. The key is to start now and prepare, he said.
When HACCP became mandatory for meat and poultry, Pennsylvania had one of the largest industries in the nation with 430 establishments, McConnell said. It's down to about 300 establishments today. Companies didn't disappear overnight.
"But a year to two years later, some companies said, 'Enough is enough, we're out of business. It's time to retire,'" he said.
Snack food is one of those industries that will be required to meet the new standards, which is a huge change because the way in which snack foods are prepared usually makes them a low risk for food-borne illnesses.
Think about dry pretzels and salty potato chips. Low moisture in products reduces risk, said James McCarthy, president and CEO of the Virginia-based Snack Food Association. But it, too, saw the need for increased safety and worked alongside other food groups to help Congress write FSMA.
In general, the industry is prepared for the changes, McCarthy said. The FDA has given assurances that, although the law was supposed to go into effect immediately, it won't start enforcement until regulations are meted out, he said.
As with other industries, there are large international companies with dedicated staff and resources to meet regulations, and there are small family-owned companies where resources are less, McCarthy said.
"We want to make sure that the smaller companies are given a little extra time to meet these (regulations) and they won't be overly prescriptive," he said.
In many cases, even the small food companies aren't worried about the new regulations.
"I think it protects us as a business," said Carla Noss, vice president of New Cumberland-based The Sunshine Tomato Co., a startup tomato sauce company.
Noss and her husband, Don Noss, have been producing low-acidity yellow tomato sauce for about a year and selling it at farm markets and fairs. They've found a processor to make larger quantities and are seeking retail outlets.
Canned and jarred foods have strict quality standards to begin with, but the Nosses also own Sir D's Catering and deal with state health inspectors all the time, so they're prepared for new safety standards, Noss said. That includes tracing the supply chain.
"If you're in business, you want to make sure you are up to speed," Noss said. "I want to make sure everyone's safe and people are enjoying my product."
Even though food companies are vigilant, many are scrambling for how they'll meet the track-and-trace portion of the regulations, said Bob Adams, president of Apak Group, a Dauphin County company that works with manufacturers for monitoring, tracking and automation technology.
Making sure you can pass an audit with proper documentation for suppliers is the largest concern, he said. At the May 1 Pennsylvania Association of Milk, Food, and Environmental Sanitarians Conference in State College, companies were eager for information about traceability options because they want to prepare for FSMA.
"Anyone can pass an audit with endless resources," Adams said. "But infinite resources are not always available."
Larger companies are beginning to be mentors to smaller companies through such discussion, said Peggy Good, the quality assurance manager for Lancaster County-based Turkey Hill Dairy Inc.
Turkey Hill has been certified under Safe Quality Foods and the Global Food Safety Initiative since 1999, Good said.
"We're evolving," she said. "It's a place we want to go anyway, so we're there. Most of the cost associated with stringent food safety, Turkey Hill Dairy absorbed years ago."
Despite the challenges presented by more regulations, it's a necessity for the entire industry, she said.
"There's too much on the line in food safety," Good said. "You need to know where your supplies came from."
To see complete FDA rule proposals, guidance and other information for produce, food manufacturing, imports and packaging facilities, visit the agency’s Food Safety Modernization Act website at www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm.
Pressure, science, scandal led to laws
A number of factors led to the 2011 Food Safety Modernizaton Act, including new science on how food-borne illnesses spread to retailers and public pressure to rein in companies with disregard for public health.
“Like anything else, there are better actors in these areas than others, but FSMA is going to force those who do a bad job at this to clean up their act,” said Alan McConnell, director of the Food Science & Technology Center at Harrisburg University of Science and Technology.
Peanut Corp. of America, which filed for bankruptcy in 2009, was one of the worst examples of a company shirking its responsibilities, including decades of poor sanitation allegations and high-profile cases of food-borne illnesses in its peanut products. In February, four former company officials were indicted on conspiracy, fraud and other charges in connection to a 2009 salmonella outbreak.
In the past, peanuts, spinach and other fresh produce were considered relatively low risk for contamination, McConnell said. Cases of people getting sick from such food changed how science looked at food safety and disease transmission.
Retail outlets, faced with being the middle man between food companies and the buying public, also started putting greater pressure on suppliers to improve, he said.
“The food safety protocols here at Giant are second to none,” said Chris Brand, a spokesman for Giant Food Stores Inc. The Cumberland County-based retailer, which is owned by Dutch company Ahold, requires suppliers to use stringent Global Food Safety Initiative standards, he said.
Other factors, such as a diverse and complex food supply, necessitate closer inspection.
“We have a lot more processed foods, which complicates that supply chain,” McConnell said. “And we’re sourcing more processed and raw foods from foreign sources.”
The potential for widespread public health crises necessitated change, he said.