WASHINGTON — Bakers should be given the flexibility to create food safety plans that are effective but appropriate to their individual businesses, according to the American Bakers Association.

In a letter submitted Aug. 22 to the Food and Drug Administration, the A.B.A. shared its views on “Preventive controls for registered food and animal food/feed facilities.” The request for comments was published May 23 in the Federal Register. The letter was sent by Lee Sanders, the A.B.A. senior vice-president of government relations and public affairs.

Ms. Sanders emphasized the need for the F.D.A. to avoid a “one-size-fits-all approach” in developing guidance is success is to be achieved. Additionally, she urged the F.D.A. to ensure that any guidance is based on sound science and is cost effective.

She noted baking companies produce a wide variety of products consumed by the public and ship the products in an array of different package sizes.

“It is easy for an average bakery to have 200 s.k.u.s (stock-keeping units) or more within their production portfolio, recognizing that some items may be seasonal,” Ms. Sanders said. “As F.D.A. develops guidance for bakeries, the guidance should be such that it could be utilized by a variety of baking companies regardless of the size of or nature of their operations.”

The F.D.A. is seeking comments regarding the identification of hazards and control measures appropriate for various types of food and methods of manufacturing or processing.

More specifically, the F.D.A. asked for input about hazard analysis, process controls, validation of controls, sanitation controls, supplier controls, allergen controls, environmental monitoring for salmonella and for Listeria monocytogenes and microbial testing.

Other input sought by the F.D.A. included, “specific biological, chemical, radiological, and physical hazards and controls for food types such as (but not limited to) spices, nuts, ready-to-eat food, bakery products, fresh-cut produce, milk products, and medical food.”

The request is an outcome of a Food Safety Working Group established in March 2009 by President Obama and chaired by the Secretaries of the Departments of Health and Human Services and Agriculture. The objective of the group was to upgrade U.S. food safety laws, enhance coordination of food safety efforts and ensure adequate enforcement of laws.

“The F.S.W.G. also recommended that food regulators move aggressively to implement sensible measures designed to prevent food safety problems before they occur,” the F.D.A. said in the May request for comments.
Earlier this year, the F.D.A. Food Safety Modernization Act was signed into law, requiring food companies to “take certain actions, including to evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility and to identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards,” the F.D.A. said.

Under the law, a written plan must be prepared to describe the procedures used by the facility to comply.
The A.B.A. endorses the “risk-based, preventive approach toward food safety prescribed” in the new law, Ms. Sanders said.

With the new law, she said the A.B.A. has established a working group that is engaging AIB International and member companies to develop a “resource ‘tool’ that would help standardize the steps for hazard analysis and risk assessment and the development of appropriate preventive controls of the baking industry.”

Ms. Sanders said the tool could be shared with the F.D.A. once it is completed. She noted the A.B.A. has sought additional time in its work on the project but that its request was not granted.

Given the ongoing nature of the A.B.A. work, Ms. Sanders offered a broad look at current baking industry practices, touching on many areas mentioned by the F.D.A. in its request. She also asked the agency to view preventive control implementation as an “iterative process, considering, reviewing and incorporating new information as appropriate and as it becomes available.”

Reviewing for the F.D.A. practices in the baking industry, Ms. Sanders identified two areas as “well-controlled and managed: physical contamination and baking.” She noted that baking serves as a kill step, controlling microbiological hazards.

“Further, the risk of foreign material contamination is mitigated by the use of sifters, strainers, magnets, metal detectors and other controls,” she said.

Ms. Sanders described hazard analysis and resultant risk assessment as the foundation for preventive programs, controls and plans.

Based on a flow diagram, she said “a hazard analysis is the assessment of the biological, chemical and physical properties associated with each step in the flow diagram that may cause an unacceptable health risk.”

This analysis helps point to process controls to deal with hazards that are identified. Examples she cited for such controls are time and temperature limits for holding sensitive ingredients such as liquid eggs or baking to a sufficient internal temperature. Gloves and/or hand hygiene was cited as another process control.

With process controls in place, Ms. Sanders said validation is needed to ensure steps take are capable of handling identified hazards.

“Cleaning and sanitation procedures may be validated through sampling and testing of equipment and other surfaces in a food production area,” she said.

Commenting on environmental monitoring, Ms. Sanders said bakers need effective programs to test for the presence of microorganisms in a baking plant

She said baking plants commonly sample and test the “post-bake/post-lethality environment in the manufacturing facility for non-pathogenic indicator organisms using the zone concept.” A positive finding may indicate the need for a revision in cleaning practices.

“Routine microbiological testing of many ready-to-eat bakery products is of limited value as it provides only ‘snapshot in time’ data,” Ms. Sanders said. “Microbiological testing is more suited to data collection/analysis for risk assessment, validation and challenge studies and verification activities.”

Wrapping up her comments, Ms. Sanders emphasized the need for flexibility not only based on differing products but on different company sizes.

“Baking is still in some cases a hand operation with little automation,” she said. “For example, small bakeries are generally more labor intensive so there may be more opportunity for visual inspection to assure food safety and less reliance on technical programs.”