Evolution of a State Food Safety Program
By Oscar Garrison
Traditionally, state food safety programs have focused on basic facility sanitation, Good Manufacturing Practices (GMPs) and economic issues with a strategy of two inspections per year at all firms, relying on inspections that only captured a snapshot. This gradually evolved to encompass more risk-based inspections with a continued focus on sanitation and GMPs. Currently, a state food safety program must cover facility sanitation, GMPs and economic issues; however, now the focus is on preventive controls, process approval, record review and the facility’s overall commitment to food safety and public health. Embracing this enhanced inspection model requires a group of professionals who have a balance of assets, including a commitment to public health, education and the philosophy to educate as we regulate.
There is also an inherent difference between retail facilities that sell food and those that manufacture it. The challenges associated with each different type of inspection require enhanced training and expertise. This, combined with differing federal regulations by program, has led to the separation of retail and manufacturing programs. Typically, state and local food safety agencies model their science-based regulations after a federal document. Many states adopt the U.S. Food and Drug Administration (FDA) Model Food Code as the basis of retail food sales and foodservice regulations. Dairy programs adopt or model regulations and laws after the Pasteurized Milk Ordinance (PMO). Meat and poultry programs must be equal to the federal program administered by the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service. Manufactured food programs generally adopt or model regulations from the Code of Federal Regulations and other federal guidance documents. In recent years, some state programs have had to promulgate regulations to cover a range of issues from the “cottage” food industries to preventive controls such as food safety plans and finished product testing—and without many documents from which to adopt them. Passage of the Food Safety Modernization Act (FSMA) requires state programs to adopt additional laws and regulations. This, along with inspection mandates, will require a direct infusion of federal funds to state programs.
Seemingly few days, if any, go by without one or more food recalls. Intensive product testing being conducted by industry and the regulatory communities, and issues associated with allergens, have led to this increased number of recalls. The ability to detect contaminants, both microbiological hazards and chemical and pesticide residues in parts per trillion, has raised the awareness level of both industry and regulators. Essentially, we are in a time in which “zero” does not exist. If there is no tolerance for a particular substance, then any detectible level is concerning, no matter how minute. The development of the Georgia Department of Agriculture’s Food Processing Section as a stand-alone group began shortly following the Salmonella outbreak associated with peanuts and peanut products in 2009.
SB 80 and Preventive Controls
As a direct result of the 2009 outbreak, the Georgia Legislature passed Senate Bill 80 to enhance the Georgia Department of Agriculture’s manufactured foods program. Senator John Bulloch authored the bill, which required mandatory testing and reporting of ready-to-eat manufactured foods and ingredients produced in the state. The bill requires firms to notify the Georgia Department of Agriculture of any positive test result obtained within 24 hours even if the product remained in the control of the company. Other provisions outline the department’s ability to recognize preventive controls such as a written food safety plan and adjust the mandatory testing frequency accordingly. The department also must promulgate regulations to outline the provisions of the law. This was a major challenge.
Most state programs utilize federal laws, regulations and guidelines to develop science-based regulations. In Georgia’s case, there were no federal standards or guidelines to reference. As the development of these regulations began, several concerns quickly came to light. The issue of presumptive positive test results and resampling had to be addressed: if a company conducts a test and receives a presumptive positive, it must either confirm the presumptive with the same sample or report the presumptive as a positive test result. What a company can’t do is use a negative result from a different sample to negate the positive result. The second issue was the burden of “test and hold” for lots being sampled. Most food manufacturers have elected to hold product lots pending negative test results. If a positive is obtained, they must report it to the Department of Agriculture within 24 hours. However, they do not have to recall that particular product because it is not in commerce.
The Beginning of the New Program
Today, the Georgia Department of Agriculture Consumer Protection Division has four sections: dairy, food processing, retail food and poultry graders. In addition to the development of regulations related to SB 80, the department faced additional challenges in developing a regulatory section for the program. Previously, our retail and manufactured foods program had been a combined section consisting of approximately 17,000 regulated facilities. These included major food processing operations, grocery stores and convenience stores. The Georgia General Assembly agreed to fund four positions for this program. Under the leadership of Georgia Department of Agriculture Commissioner Gary W. Black, the program has grown to eight positions by redirecting resources throughout the division. Black’s commitment to food safety, coupled with a risk-based inspection approach and an “educate as we regulate” philosophy, has been instrumental to the enhancement of this program.
In the past, food safety training has been difficult for state and local programs. The transfer of knowledge has mostly been on a local level. The funding necessary for staff to travel to out-of-state trainings, coupled with the lack of availability to state and local regulators, was problematic. Now we have more training opportunities than ever before. The FDA launched the Office of Regulatory Affairs University. This online university provides training to regulatory participants, who are an excellent resource for new hires, and those needing continuing education units. Our sanitarians are required to complete all 38 online courses to meet level-two training status. The International Food Protection Training Institute (IFPTI) in Battle Creek, MI, has also made trainings available that previously were rarely available to state programs. In addition to Internet and internal training, we have logged more than 2,400 man-hours of training hosted by IFPTI, FDA, USDA and other sources. The FDA’s Training Branch has also had a significant increase in the number of slots offered to state food safety programs. The courses include FD150 (Food GMPs), FD151 (Food Inspection Techniques and Evidence Development) and FD152 (Food Processing and Technology), which are now part of the robust training requirements for all food processing specialists in Georgia. The commitment of FDA and the training of state food safety regulators have made instrumental enhancements to our program, and the continued partnership and support between FDA and IFPTI are a vital component of an integrated food safety system.
However, this training equation is missing one vital piece: industry. The training currently being offered to regulatory personnel must also be available to industry. Furthermore, some of this training should be conducted with a balance of regulatory and industry participants. As we move to a food safety system focused more on prevention, we must train together on the latest scientific principles associated with food-borne pathogen control. Industry also brings an invaluable component to the table: the more regulators learn about the preventive controls being utilized, their implementation and the Sanitation Standard Operating Procedures (SSOPs) within a facility, the more we recognize a company’s commitment to food safety—thus lowering the risk of the facility. This will allow regulators to focus resources on higher-risk facilities. Industry has utilized cutting-edge technologies and systems to ensure the safety of the foods they produce. In many cases, the regulatory community may be largely unaware of these technologies and systems. The validation of these technologies and the education of everyone, including consumers, on the benefits will be key to enhancing food safety.
FSMA and Integration
With the signing into law of the FSMA on January 4, 2011, state programs now face new challenges and opportunities. The act has five major pillars: prevention, enhanced partnerships, accountability through inspections, compliance and quick response to outbreaks and import safety. State and local food safety programs will play major roles in the successful implementation of these five pillars. FDA must rely on other food safety agencies to conduct inspections (provided they meet FDA standards). FDA must also develop and implement strategies to leverage and enhance the food safety and defense capacities of state and local agencies. These capacity upgrades must include direct investment in state programs with a long-term commitment.
In addition to capacity building, all regulatory agencies must develop a framework for accurate and timely communication of information. This should include the sharing of information concerning observed noncompliance domestically and internationally, positive lab results and trends of foodborne illness outbreaks. This information will make work planning among stakeholders more efficient and allow more effective allocation of resources. The conservation of resources at all levels will be a necessity as partnerships are forged between state and local programs with FDA to meet the congressional mandate for inspections domestically and internationally. State laboratory capacity must also be enhanced to expedite the use and availability of sample data, and must include laboratory accreditation, training in sampling and laboratory analysis methodology. State programs have seen a significant increase in training opportunities; however, additional resources must be employed to expedite this process, allowing states to meet the training standards more efficiently.
Implementing these changes depends on the development of a number of regulations and guidelines. During this process, it is vital that all stakeholders provide input. FDA recognizes the importance of this, which can be seen in the track the Produce Safety Regulations have taken. These regulations will establish mandatory, science-based, minimum standards for the safe growing, harvesting, sorting, packing and storage of fresh fruits and vegetables. In 2010, prior to the drafting of these regulations, food safety partners traveled to farms across the country and talked with farmers about food safety and the concerns of additional regulations, allowing for a better understanding of food safety practices currently being implemented. Many farms have voluntarily utilized Good Agricultural Practices for many years. As the process moves forward, FDA will publish a proposed rule and take public comment. The information presented by all stakeholders will be necessary for the success of each program.
Industry will play a vital role in the development of an integrated food safety system. The relationships companies forge with regulatory agencies will allow the flow of critical information and training both vertically and horizontally. Many associations and groups are fostering this open communication in a structured environment, with the Association of Food and Drug Officials (AFDO) serving as the premier association. Members include regulators from across the country in the food and drug arena and the regulated industry. The sharing of information between members, the networking opportunities and the consistent promoting of public health are major benefits of membership. AFDO has been awarded a cooperative agreement with FDA to develop an Alliance for Advancing a National Integrated Food Safety System and will assist FDA in meeting the mandates of the FSMA.
Our state university systems will play a major, ongoing role in the food safety continuum. Many of the services geared to the protection of public health are becoming stressed. Many universities provide product process classification and processing authority services. These programs are being overwhelmed by demand for product classifications and inquiries from the cottage foods industry. Growth in these areas has delayed the delivery of these critical services focused on developing and verifying preventive controls for ensuring product safety. The research and development being conducted at Fort Valley State University, Georgia Institute of Technology and The University of Georgia bring together the latest in processing technologies, pathogen reduction and detection methods. The products developed from the research of today will be our preventive controls of tomorrow.
Manufactured Food Regulatory Program Standards
The Georgia Department of Agriculture is currently enrolled in the Manufactured Food Regulatory Program Standards (MFRPS). FDA set up the standards to help ensure consistency of inspections between the state, local and federal levels. Through their implementation, a state or local agency can build the foundation for its regulatory program. MFRPS’s focus on self-assessment and program evaluation has been a tremendous help in the continued development of our Food Processing program. FDA has supported the adoption of the standards by making funds available to states for implementation, and to address critical needs noted during their self-assessments. Continued financial support will be necessary in the future, as the standards will take years for states and localities to fully implement.
Unlike many other programs around the country, Georgia has not experienced severe budgets cuts to its manufactured foods program. Cuts have come across the board to all agencies but not to food safety. Regardless of the size of the cuts, unless adjustments are made, programs suffer; thus, they must evaluate what they do, why they do it and how they can better protect public health. A true risk-based inspection is the answer to resource problems, but its development is not an overnight process by any means. To be truly effective, it must be continually evaluated and improved upon based on advances in food science. At the infant stage of implementation, a baseline must be established to inventory a firm’s preventive controls, including implementation of food safety plans, process approvals and verification, unannounced third-party audits, SSOPs and product and environmental testing programs. There are many other factors to be considered, and finally, a ranking system must be developed to include preventive controls, past compliance issues, recalls and an assortment of other criteria. The facilities will basically fall in one of three categories with resources allotted based on the risk of product and preventive controls in place. This process sets forth a system to develop industry partnerships with companies committed to food safety and focus resources on facilities needing extra attention.
With the implementation of the FSMA, FDA must partner with states to meet the new inspection mandates. Most states currently inspect manufactured food facilities at least once per year. According to an AFDO resource survey, 90 percent of food safety inspections conducted in this country are performed by state and local jurisdictions. The FSMA allows FDA to make investments in state programs to build capacity. This investment must be tied to the MFRPS. As a state develops improvement plans for its program, funds must be made available to meet these plans. Again, this will take time, but we must begin immediately with the resources available.
As food safety programs nationwide continue to change and adapt to the ever-moving world of protecting our food supply, we must continue to improve on the process. When we look at the basic principles outlined in the FSMA, states must work with federal agencies to expand partnerships, enhance accountability through inspections, gain compliance and improve quick response to outbreaks. Federal agencies must focus on import safety in order to create a truly preventive food safety system. As we continue to implement advanced approaches to food safety, the ability of federal agencies to infuse state programs with additional funds will be critical. Enhanced funding of state programs will also be necessary to maintain resources and educate public health professionals, which is one of the most important aspects in keeping up with the curve. Making progress will require continued research and development of new technologies and rapid detection methods. As we move forward with the advancement of these programs, all stakeholders must continue to educate as we regulate to make our food as safe as possible.
Oscar Garrison is the director of the consumer protection division at the Georgia Department of Agriculture and serves as the president of the Association of Food and Drug Officials of the United States.