Inspectors found deficiencies in plant design, pests in the processing area and failure by employees to wash hands at one cheese processing facility. How clean is your plant?

Last year, in response to an outbreak of a rare strain of E.coli 0157:H7 reported in cheese samples sold at Costco Wholesale stores, based in Issaquah, Wash., the Food and Drug Administration, Washington, D.C., inspected the Bravo Farms Cheese processing facility in Traver, Calif. According to an FDA report, inspectors found:

• Deficiencies in plant design.

• Failure to manufacture foods under conditions and controls necessary to minimize the potential for growth of microorganisms.

• No reasonable precautions being taken to ensure that production procedures do not contribute contamination from any source.

• No effective measures being taken to exclude pests from the processing areas and protect against the contamination of food on the premises by pests.

• Suitable outer garments were not worn to protect against contamination of food, food contact surfaces and food packaging materials.

• Failure to provide hand-washing and hand-sanitizing facilities at each location in the plant where needed and wear beard covers where appropriate.

Azteca Linda Corp. received an FDA warning letter as a result of federal inspectors finding Listeria in its Brooklyn, N.Y., cheesemaking facility. In July 2010, Azteca recalled its Queso Fresco (fresh white cheese) and Queso Hebra (fresh white string cheese) due to contamination, and recalled these same products again in August 2010. It also recalled its Queso El Azteca brand of ricotta cheese for contamination. Inspectors found:

• Standing water in the cracked and pitted floor directly underneath the stainless-steel Queso Fresco table.

• Standing water in the cracked and pitted floor beneath the pasteurizer and in front of the exit of the processing room.

• Broomstick bristles and a black dust pan stored in the processing room.

Industry observers say dairy processors, in general, run safe and clean plants. But many processors are going the extra mile to ensure they’re producing the safest products possible. Processors must comply with state and federal laws and follow general, good manufacturing practices.

Marina Mayer, executive editor of Dairy Foods, talks to some organizations to find out what each law entails, how they impact the dairy industry and what processors are doing to follow the rules.

Making it a law

On Jan. 4, President Barack Obama signed into law the Food Safety Modernization Act (FSMA), which modernizes the food safety system to better prevent illness and better respond to outbreaks. It’s designed to give the FDA and the Secretary of Health and Human Services, Washington, D.C., the authority to regulate food, suspend registration of a food facility and order a recall when necessary. It also gives FDA access to plant records during routine inspections and holds manufacturers accountable for assuring the safety and quality of the ingredients they use, says Clay Hough, senior group vice president and general counsel for the International Dairy Foods Association.

“The biggest impact of the FSMA on IDFA member companies will be the new rules that impact daily operations,” he adds. “These include food safety and preventative controls plans, supply-chain management, record maintenance and access and food defense plans.”

The scope of the FSMA

FSMA is applied to all foods, including dairy, Hough says. “So, during the legislative process, IDFA worked with Congress to try to avoid duplication. For instance, language was included that authorizes FDA to coordinate with state inspection programs such as the state-based inspections under the Pasteurized Milk Ordinance (PMO) to meet the FSMA’s inspection requirements,” he adds. “Under the Memorandum of Understanding with the National Conference on Interstate Milk Shipments (NCIMS), we expect FDA will continue to rely on inspections for Grade ‘A’ milk facilities conducted by the states to ensure compliance with the PMO. The states have the needed expertise to conduct these inspections, so FDA can apply its inspection resources to other areas. The FDA should conduct audits of the state inspection programs to ensure nationwide consistency. IDFA supports FDA’s continued work with the NCIMS to be sure that the PMO is updated, as appropriate, to be consistent with FDA food safety standards under the new law.”

In addition to the Grade “A” Dairy PMO programs, dairy plants must also adhere to strong, ongoing Good Manufacturing Practices (GMPs) programs, Hough advises. “These include maintenance of the plant surroundings and the integrity of the plant facility to prevent entry of pests, extensive training of processing personnel regarding personal hygiene and plant operations, detailed maintenance and cleaning of the processing facility and its equipment, correct storage and handling of food ingredients and packaging and proper temperature control of the food product during processing and storage,” he notes.

Because of all of these food safety measures, dairy products are among the safest and most regulated foods in the country, Hough adds.

“Dairy farms and plants must meet stringent federal and local regulations, including those developed by the U.S. Department of Agriculture (USDA), the FDA and state regulatory agencies. Dairy plants are inspected frequently by state agencies, the FDA and USDA. Milk and dairy foods go through extensive and rigorous safety and quality protocols before they reach the grocery store. In fact, according to FDA, today less than 1% of foodborne illness outbreaks in the U.S. involve dairy products,” he notes.

So then why the call for a national overhaul of dairy processing plants?

Food recalls have risen dramatically over the past three years, according to Hough, with the ice cream category experiencing some of the hit thanks to an increase in recalls of ice cream products that used potentially-contaminated peanuts, peanut paste and nuts for flavoring.

However, other dairy products such as milk, yogurt and cheese were not impacted.

“In fact, over the past three years, milk and cultured dairy products have had only a few recalls, but recalls in cheese increased in 2010 due to increased surveillance and testing for pathogens in soft cheese and cheese made from raw milk,” Hough states.

Another act to follow

When it comes to food safety in the dairy industry, there are two main causes for concern - biological and chemical contamination.

That’s why the Federal Food, Drug and Cosmetic (FD&C) Act plays a significant role in controlling food safety issues by giving FDA the ability to oversee the safety of food, drugs and cosmetics. This act was introduced in 1938 and has since been amended several times.

“By and large, the dairy industry does a good job of ensuring compliance with the FD&C Act, but there is always room for improvement,” says John Sheehan, director, division of plant and dairy food safety for FDA’s Center for Food Safety and Applied Nutrition. “The dairy industry should continue to work to ensure that the foods it produces are safe to eat and not adulterated within the meaning of the FD&C Act.”

For instance, raw milk and raw milk products are of particular concern, as well as certain types of raw milk cheeses, such as fresh, un-ripened, soft, soft-ripened and even some semi-softs, due to the fact that they’re not pasteurized.

According to the FDA’s website, most of the milk sold in the United States is pasteurized, where it is heated to 161°F for 15 seconds. But many of today’s consumers are getting “back to nature” by turning to products made with raw milk, including cheese and yogurts, because they are said to be more nutritious. The FDA says that’s not true. “Although the heating process slightly affects a few of the vitamins - thiamine, vitamin B6 and folic acid within the B-complex and vitamin C - the changes are not significant. Meanwhile, there is a risk that milk could be contaminated by environmental factors such as soil or animal feces, animal diseases or bacteria on an animal’s skin,” the site says.

“Manufacturers of dairy products generally must endeavor to ensure that their manufacturing environments remain free of environmental pathogens and that their products do not contain pathogens,” Sheehan says.

Processors have to watch for allergens, too. Publix Super Markets, Lakeland, Fla., for example, issued a voluntary recall in January for its private-label Premium Light Tiramisu ice cream, which may contain coffee almond fudge ice cream bits, or an undeclared almond allergen.

“One of the greatest reasons for recalls is undeclared allergens in ice cream,” says Gary Ades, president of G&L Consulting Group LLC, Bentonville, Ark., and chairman of the executive education council for the Food Safety Summit, a sister publication of Dairy Foods, Washington, D.C. “Dairies are working to assure that products are not contaminated after any biological ‘kill’ step (e.g., pasteurization).”

Concerns also rise when dealing with raw milk, Ades says. “It is hazardous. The use of raw milk in cheesemaking is being re-evaluated regarding the length of aging that is needed to mitigate biological risks,” he adds.

As a result, dairy processors are kicking their food safety steps into high gear by enhancing raw ingredient supplier approval programs, reviewing and updating internal processes and procedures, implementing tighter documentation policies and upgrading software, equipment and traceability.

“Any product is susceptible to contamination if proper processes and procedures are not in place,” Ades notes. “If a product does not have a kill step or may be contaminated from ‘add-ins’ that are incorporated after the kill step, they pose a risk.”

Dairy processors keep it safe

Regardless of how many laws are in place, the dairy industry has been ahead of the curve in recognizing the need for real-time tracking and traceability, Hough says.

“Companies know where their raw ingredients come from and where their products go when they leave the plant. Recording all ingredient lot numbers is industry practice for all stages of production and processing,” he adds. “[Plus], the advances in herd management and animal health coupled with advances in processing equipment design, installation, operation and a better understanding of product flow throughout the facility have contributed to a better business operation.”

On the flip side, any regulation makes it more difficult for processors to market their products and find the financial means to develop new products that meet or exceed standards, says Jim Dimataris, director of processor relations for California Milk Advisory Board, South San Francisco, Calif.

Yet, the dairy industry continues to go the extra mile in ensuring proper safety measures.

“The dairy industry has always been the leader in cleaning and sanitizing its plants,” Ades says. “There are no magic bullets. The basics of good manufacturing practices, especially cleaning and sanitizing, temperature control, employee training and management commitment are the keys to food safety.”