The American Bakers Association (ABA) submitted a comment letter to the U.S. Food and Drug Administration (FDA) regarding its notice and request for comments on «Preventive Controls for Registered Food and Animal Food/Feed Facilities».
ABA Weighs in with FDA on Bakers´ Food Safety Preventative Controls. The American Bakers Association (ABA (external link)) submitted a comment letter (as follows) to the U.S. Food and Drug Administration (FDA) regarding its notice and request for comments on «Preventive Controls for Registered Food and Animal Food/Feed Facilities» published in the U.S. Federal Register on May 23, 2011. 76 FR 29767:
The ABA is the Washington D.C.-based voice of the wholesale baking industry. Since 1897, ABA has represented the interests of bakers before the U.S. Congress, federal agencies and international regulatory authorities. ABA advocates on behalf of more than 700 baking facilities and baking company suppliers. ABA members produce bread, rolls, crackers, bagels, sweet goods, tortillas and many other wholesome, nutritious, baked products for America´s families. The baking industry generates more than 70 billion USD in economic activity annually and employs close to half a million highly skilled people.
The ABA and its members believe that food manufacturers are responsible for ensuring the safety of the food they produce. ABA supports the risk-based, preventive approach towards food safety prescribed in the Food Safety Modernization Act (FSMA) (Pub. L. 111-353), that was signed into law earlier this year. As the FDA begins implementation of the FSMA, it has asked for information on how food facilities are addressing preventive controls. This letter represents some of the current practices on how bakeries identify potential hazards and then work to mitigate these hazards. Most importantly, ABA believes that for any preventive control guidance to be successful it should have the following key elements:
- It should contain flexible guidelines to meet the needs of individual baking companies (both large and small), recognizing that bakeries have different issues and resources such that a «one size fits all» approach is not appropriate, and
- It should be science-based and cost-effective.
The baking industry has a long and successful record of protecting consumers through producing safe and nutritious grain-based products. Some bakeries implemented HACCP over 20 years ago and have successfully used HACCP and the corresponding prerequisite programs to build a solid food safety foundation. ABA believes that these existing food safety programs should serve as the basis for the hazard analyses and preventive controls that are developed at a bakery. Accordingly, ABA believes it is important for the FDA to understand the current nature of practices and procedures in bakeries and appreciates the opportunity to convey such information to the Agency through these comments and through future collaborative efforts.
ABA has put a working group in place that is engaging AIB International and member companies to help develop a resource «tool» that would help standardize the steps for hazard analysis and risk assessment and the development of appropriate preventive controls for the baking industry. Once this tool is developed, it could be shared with the FDA. ABA requested additional time to consolidate information about general practices in the industry. While this extension has not been granted, we recommend that the FDA consider preventive control implementation as an iterative process, considering, reviewing and incorporating new information as appropriate and as it becomes available.
The baking industry and its production facilities produce a large variety of baked products that are consumed by the public. Individual bakeries may produce baked products in family packs, jumbo size, individually wrapped and variety packs to name just a few. Additionally, bakers produce a variety of products such as sweet breads, white bread, wheat bread, buns, rolls, muffins, cakes, cookies, bars, crackers, doughnuts and so forth. It is easy for an average bakery to have 200 SKUs or more within their production portfolio, recognizing that some items may be seasonal. As FDA develops guidance for bakeries, the guidance should be such that it could be utilized by a variety of baking companies regardless of the size or nature of their operations.
Based on our experience within the baking industry, there are two areas that stand out as being well-controlled and managed: physical contamination and baking. For example, baking serves as a «kill step» as it eliminates significant microbiological hazards. Further, the risk of foreign material contamination is mitigated by the use of sifters, strainers, magnets, metal detectors and other controls. Our comments below reflect on these two key areas and the other areas where FDA has requested public comment.
Conducting a Hazard Analysis
A hazard analysis and the resulting risk assessment form the foundation for prerequisite programs, preventive controls and HACCP or HACCP-type plans. A best practice is to form a multifunctional team. This team will develop the process flow diagram, conduct the hazard analysis and risk assessment and work closely with the manufacturing facility to develop and implement prerequisite programs, preventive controls and HACCP or HACCP-type plans to address the identified hazards that are reasonably likely to occur.
The first step is to prepare a process flow diagram that accurately provides a description of the steps from the receiving of raw materials through all of the manufacturing processes to the packaging of the finished product and its distribution. An on-site review of the flow diagram should be performed to verify its accuracy.
Once the flow diagram is verified for accuracy, a hazard analysis can be conducted. 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. A best practice to identify where a potential hazard can occur is to systematically review each step in the process using information such as known biological and chemical properties, physical hazards unique to the facility, equipment or process and scientific data. Facilities should then conduct a risk assessment for each potential hazard identified to determine if it is reasonably likely to occur.
To best determine whether a potential hazard is reasonably likely to occur, the bakery should consider whether the potential hazard is one for which a prudent processor would establish controls because experience, consumer data, scientific reports or other information provide a basis to conclude that there is a reasonable possibility that it will occur if those controls were not in place or were not operating properly. It is a best practice for the hazard analysis and risk assessment to be reviewed annually or whenever changes to the product or process occur and revise if necessary.
ABA believes benchmarking between facilities and with the baking industry can be an effective way to assure that hazards and the associated risks are fully identified and assessed, although the assessment must be considered based on the specific situation and conditions that exist in each facility. ABA also supports industry sharing of best practices for preventive controls.
The hazard analysis determines points in the process where hazards can occur, assesses the risk and identifies prerequisite programs and preventive controls that can eliminate, mitigate or allow for detection of the identified hazard. Often the preventive controls include implementing process controls. The process control describes an ideal process condition with limits of acceptability based on process capability and an acceptable safety buffer to eliminate or reduce the risk to an acceptable level. One type of process control used in the baking industry is «time and temperature». For example, time and temperature limits are defined for holding sensitive ingredients like liquid eggs. The user of the sensitive ingredient establishes a program to monitor the holding temperature and the time since receipt and before use in order to keep these in compliance with the established limits. The established limits are typically developed by the producer based on testing and scientific data.
Baking is another example where temperature is used as a process control. When baking bread, sufficient internal temperatures (185-200?F) must be reached to gelatinize the starch and provide the appropriate physical structure and texture to the product to convert it from dough to bread. If this temperature is not reached, the product does not become bread, will not maintain its shape when removed from the baking pan and does not have ample internal structure to be successfully sliced. The baking industry traditionally uses the physical structure and internal texture of the product to indicate internal temperatures adequate to destroy vegetative cells of microorganisms of concern have been reached. (ICMSF. 1996. Microorganisms in Foods 5 – Characteristics of Microbial Pathogens)
Other examples of process controls include the use of gloves and/or hand hygiene and the use of foreign material control devices. Bakery employees involved in direct product contact activities that occur in the post-bake/post-lethality process areas use gloves and/or hand hygiene to reduce the risk of product contamination. Many bakeries use sifters, strainers and magnets in dry and liquid bulk ingredients receiving and storage systems as part of their foreign material control programs.
It is the responsibility of the food manufacturer to produce and distribute a safe food product. Product and process validation are complex issues. No single method will work in all cases. To follow are a few examples of how bakers have put steps into place to mitigate risks through process validation. Validation is a process of obtaining evidence that the control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specific acceptable level.
Cleaning and sanitation procedures may be validated to be effective by environmental monitoring through sampling and testing of equipment and other surfaces in a food production area and confirming the results meet the microbiological criteria established for the microorganisms of concern. After a thorough initial assessment, this same process with a reduced rate of sampling and testing, focused on areas where vegetative cells of microorganisms of concern may be present, is a recommended on-going program of verification that the cleaning and sanitation procedures are being implemented properly.
Metal detection is a validated process that is used successfully in the baking industry to mitigate the risk of foreign material (metal) contamination. Bakers validate the performance of metal detectors to detect specific size pieces of metal at a defined frequency to assure that the unit is effective at detecting and rejecting metal at different points in the manufacturing process. Once the metal detection equipment has been validated, verification programs are implemented to assure proper performance. A specific example of the use of the validation process in the baking industry was the establishment of the voluntary protocol to assure the safety of an unrefrigerated pumpkin pie product through the course of its shelf life. This validation protocol was developed by a baking industry coalition as part of a multi-year project. Validation studies were used to determine that pumpkin pie is safe for distribution and display without refrigeration until opened and used by the consumer when the protocol is followed. The validation process confirmed that, among other things, if the product reaches a sufficient temperature (in this case, 180° F) during the baking process, the manufacturing process is capable of producing a product that is microbiologically stable and safe for distribution and display without refrigeration. («Voluntary Protocol for the Safety of an Unrefrigerated Pumpkin Pie Product During Shelf and Use Life», AIB Technical Bulletin, Volume XXVII, Issue 05, May 2005)
ABA believes that the food manufacturer is responsible to develop and utilize effective sanitation procedures that are specific to the needs of the operation and conditions present. Each facility will present different issues and conditions. Sanitation best practices can be developed and shared between facilities and within industry with consideration given for the unique situation at each facility. A Master Cleaning Schedule, establishing cleaning frequency by area and the Sanitation Standard Operating Procedures (SSOP´s), outlining the procedure, tools and chemicals to be used for cleaning, can be the basis of the sanitation program. There should also be follow-up inspection of a cleaned area or equipment on a periodic basis to verify that the cleaning was done properly and that the SSOP´s were effective. SSOP´s should also be validated. Master Cleaning Schedules and SSOP´s are reviewed and revised if necessary when a food safety failure is found. SSOP´s are used to train new employees to assure that they are aware of the food safety risks and understand their responsibility in eliminating or mitigating the identified risks.
Current Good Manufacturing Practices (cGMP) serve as the basis for appropriate allergen control practices used by bakers and other food processors. In order to comply with 21 CFR 110,80, all reasonable precautions must be taken to ensure that production procedures do not contribute to contamination from any source. Food processors are responsible for ensuring that their products are not adulterated as a result of contamination with an allergen that is not specifically formulated in a food. An Allergen Control Plan is a critical component of product safety initiatives and describes the identification, storage, handling, processing, packaging and labeling of allergenic foods and food ingredients. The elements of an allergen control plan may include, but are not limited to:
- Training of processing and supervisory personnel;
- Control of employee service areas such as vending machine, meals, etc. through good personnel practices and hand washing;
- Segregation of food allergens during storage and handling;
- Appropriate allergen cleaning procedures
- Prevention of cross contact during processing through measures such as:
- Scheduling of production runs;
- Control of rework; and
- Use of dedicated production lines;
- Product label review and label usage and control;
- Supplier control program for ingredients and labels.
ABA´s Allergen Usage Guidelines Document: ABA worked with members of the baking industry to establish an allergen usage guideline for the identification and management of potential food allergens during the baking production process. ABA´s goal is to provide guidance to all bakers in the identification and management of potential food allergens, including strategies for operations, ingredients, packaging, sales/marketing, awareness and consumer response. The document provides strategies around each of the elements cited above, along with strategies related to consumer response, sales and marketing, etc. Recognizing that food allergen issues are a concern for bakers, the «ABA Allergen Usage Guidelines» (ABA 2000) are currently undergoing an update. When completed, the guidelines will be available for members and shared with FDA.
Bakers must establish an effective program to sample and test for the presence of microorganisms in the manufacturing facility. For example, an industry practice is to periodically sample and test the post-bake/post-lethality environment in the manufacturing facility for non-pathogenic indicator organisms using the zone concept, e.g. non-food contact surfaces in close proximity to food contact surfaces are zone 2, non-food contact surfaces within the processing area but more removed from food contact surfaces are zone 3 or other risk/proximity based sample site selection criteria. A positive finding may be an indication that the cleaning practices or frequency may not be adequate and may need to be revised. An effective program will identify the most likely places for the microorganisms and identify steps to eliminate their presence. The strategy of this technique is if cleaning and sanitizing procedures are capable of eliminating or keeping non-pathogenic bacteria at very low levels in processing areas, then the likelihood that pathogenic bacteria is present is extremely low. The sampling is typically focused on the area following the baking step since baking, in conjunction with good sanitation and cGMP practices, will mitigate the microbiological concerns prior to this area.
Routine microbiological testing of many ready-to-eat bakery products is of limited value as it provides only «snapshot in time» data. Microbiological testing is more suited to data collection/analysis for risk assessment, validation and challenge studies and verification activities.
ABA recommends that bakers establish an effective Food Defense program to identify potential deliberate contamination risks. The baking industry has been very proactive in educating its membership on the importance of food defense. For example, in 2010, the ABA, in conjunction with FDA, conducted a food defense risk assessment using the CARVER plus Shock method and then educated the association members on the exercise findings.
Impact on Small Bakers
Any preventive controls guidance that is implemented by the FDA should be flexible to meet the needs of different size bakeries. Baking is still in some cases a hand operation with little automation. 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.
ABA appreciates the opportunity to provide this input to the FDA as it considers an effective implementation of preventive control guidance for the baking industry. We look forward to providing more detailed information to the FDA as we work to develop a standardized tool for the baking industry.