The Food Safety Modernisation Act: A food manufacturer’s perspective

Food manufacturers in the US regulated by the Food & Drug Administration (FDA) are preparing for forthcoming challenges related to the Food Safety Modernisation Act (FSMA) which was signed into law by President Obama on 4 January 2011. The globalisation of the food supply, the aging population and an improved understanding of the food safety paradigm through better surveillance are some of the major reasons this act was needed. In general, the food industry is very supportive of this law and is working collaboratively with the Agency to develop regulations that focus on risk prevention.

FSMA is focused on four key themes: Prevention; Inspection; Compliance and Response; Import Safety and Enhanced Partnerships.

Prevention is focused on identifying known food safety hazards through the supply chain from growing, harvesting, processing, distribu – tion and finally consumption. The complexities of a global supply chain with diverse processing, products and go to market strategies makes this initiative complex. The FDA has written a detailed proposed rule on Preventive Control and at the time of the completion of this article, the rule was not available for review. The proposed rule should require food manufacturers to establish a comprehensive sciencebased food safety plan that includes the evaluation and identification of known or reasonably foreseeable hazards, monitoring the effectiveness of the identified preventive controls, and a plan in place for verification and corrective actions to prevent recurrence of any failures. Any implemented preventive control must be shown to be effective and to significantly minimise the occurrence of identified hazards, including through the use of validation of processes, environmental controls and product testing verification.

The food safety plan (or HACCP plan) must include a hazard analysis and risk-based preventive controls such as biological, chemical, physical, radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and colour additives. Finally, manufacturers must be ready to present scientific understanding of the identified hazards in their food safety plans including validated data of their processes and programs.

A special focus for preventive controls will be on produce due to recent outbreaks and a lack of consistency of control points for some produce items. Intentional contaminants will also be addressed. Many food companies have robust food defence plans. Intentional contamination intended to harm others should focus on the three Ps: perimeter, people and product. On the product side, they should include complete assessments where product, ingredients and packaging materials can become contaminated. The plan must include at minimum actions to protect against the intentional adulteration of food and sciencebased mitigation strategies to prepare and protect the food supply. This rule should go beyond food defence and address the increase in economic adulterants which have recently resulted in food safety concerns.

Inspection, compliance and response is not new to the agency, however, FSMA provides the FDA with increased authority. They now have increased access to record, mandatory recall authority, expanded administrative detention and the ability to suspend the registration of a manufacturing site. FSMA is also expecting the agency to rethink their inspection approach. From an industry perspective, facility inspec – tions and product testing are limited in value. Inspections are a point in time and testing does not assure that all products produced in a given facility are safe. One approach would be to rely on certified and accredited audits that focus on food safety programs design and execution. Once the Inspector is familiar (and comfortable) with the overall food safety plan they can supplement their knowledge with a technical walkthrough of the facility where they can spotlight areas of concern or focus on areas of interest. Regardless of the approach, product testing should only be utilised as a verification of the overall food safety plan and not be relied on for routine safety checks.

The most significant change under FSMA is the requirement for the safety of imported foods. This will require changes for certain parts of the supply chain. In many cases, imported food ingredients are handled through various parties other than the manufacturer such as Brokers and Distributors. FSMA requires these businesses to collect and retain validation records that imported foods are safe and compliant with US food safety requirements. It will also require verification of the distribution chain to ensure product safety, especially for foods that require refrigeration or freezer storage for safety. Many US food manufacturers already ensure that foreign suppliers / distributors meet food safety requirements with internal Quality Auditors. In addition to food safety requirements, food companies are also concerned about sensorial, nutritional, shelf life and other quality related attributes which are not covered under FSMA. To deal with this complexity the FDA may choose to leverage third party government agencies or audit firms to certify that foreign food facilities are compliant with US food regulations.

The FDA should also consider allowing food manufacturers to continue leveraging their internal food safety experts to verify compliance through some sort of industry based auditor certification program. If food companies are not allowed to continue with internal food safety and quality verification programs for foreign suppliers, additional unnecessary costs will be added to food that may eventually be transferred to the consumer. Regardless of the details of implementation, this portion of the act is very important and it should result in improved food safety.

Currently the agency inspects less than two per cent of the imported 24 million shipments received at US ports using a risk based program called PREDICT, or Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting. Although a risk based approach is promising, the end result is still an inspection process. The act reinforces the point that inspection alone is not the solution. Verifying food safety programs are more effective in assuring that safety of suppliers and this approach allows the agency to verify that all manufacturing sites that produce food imported into the US are meeting the minimum requirements of food safety.

It is obvious that the FDA is not staffed appropriately to implement such a monumental enforcement activity. For this reason, the need to develop enhanced partnerships will allow the agency to implement future rules fast. The agency plans to rely on state, local and international agencies to inspect facilities, improve foodborne illness surveillance and manage food safety incidents. This is a logical approach; however, the key will be in how well the agency trains and calibrates the extended inspection network. Consistency in interpreta – tion and enforcement of regulations will be critical in ensuring that the agency focuses on issues that could impact public health and wellness.

H.J. Heinz: game plan and efforts

FSMA’s requirements should not be new for food manufacturers such as H.J. Heinz with strong and well-established quality and food safety programs and controls. The Act gives companies like Heinz the opportunity to streamline food safety programs and establish uniformity across our network of plants, contact manufacturers and suppliers. Heinz has been closely following all news and changes that would be part of FSMA’s new requirements. Heinz has been actively engaged with trade associations such as the Grocery Manufacturers Association (GMA) to develop strategic partnerships and share best practices across all Heinz factories.

One thing that we are doing in preparation of future regulations is conducting thorough reviews of all of our food safety plans with internal and external subject matter experts. Reviewing existing HACCP plans, Environmental Monitoring Plans, Sanitation / GMP programs and ensuring that we are utilising the state-ofthe- art food safety devices are some of the programs under review. Although these programs are robust and are audited routinely, it can be beneficial to bring in world class experts to ensure that we are not complacent and not missing a potential hazard.

Preventive controls have been part of the Heinz DNA for many years. Heinz runs a riskbased quality program called ‘Quality Risk Management Program’ (Q-RMP) developed by a Heinz Global Quality Team. The program is designed to allow Heinz facilities around the globe to measure the effectiveness of their overall quality, food safety and GMP/sanitation systems, and to plan for and facilitate continuous improvement. The Q-RMP system is designed to measure not only what plants are actually doing (mechanisms / ways of working), but the science and rationale behind why processes were developed and actions are taken. This risk assessment program focuses heavily on food safety, ISO 9000, HACCP, risk assessment and other quality systems. In addition to the continuous improvement program and audit Q-RMP, Heinz has incorpor – ated the Global Food Safety Initiative (GFSI) FSSC 22000 into our auditing portfolio. By leveraging the third party certified FSSC 22000 as a compliance audit and our internal Q-RMP as our continuous improvement audit we believe we have one of the most robust auditing strategies in the food industry. Our goal at Heinz is to anticipate and prevent eminent food safety and quality problems while focusing on continuous improvement. This helps protect our brands and deliver safe and reliable food products for the enjoyment of consumers and customers.

Heinz has a consistent supplier quality program that is leveraged globally. All Supplier Approvals are based upon results from a rigorous risk assessment conducted by Heinz auditors.

All Auditors are trained and calibrated to ensure consistent application of the supplier verification program. Auditors are developed into subject matter experts for specific food categories such as an expert in poultry and poultry processing. This consistency allows us to leverage technical experts that are regionally based who not only know the technical requirements but the cultural nuances of the site audited. The Heinz Global Supply Chain Quality Management program is based on the identification of inherent risks associated with the specific food ingredient, regional and seasonal issues, the product formulation and processes as well as the cooking preparation that the final product will receive. Heinz leverages an internal global database that captures all of these risks and allows us to communicate effectively across the globe.

As FSMA requirements roll in for foreign suppliers, our Heinz Global Supply Chain Quality Management team will ensure that Heinz vendors are capable of complying with our quality systems, food safety and specifications requirements. The success of our program is accredited to joint efforts by the Heinz Business Unit Manufacturing Facilities Procurement, Research & Development and the Quality teams.

Record access by FDA is something new for food manufacturers who do not manufacture USDA products. Heinz has implemented a comprehensive electronic data collection, analysis and interpretation program that ensures that the proper records are retained. Leveraging an electronic data management system provides the flexibility to provide the specific records a Regulator may need during an inspection.

Future challenges

FSMA is a massive enhancement to the regulatory authority and activity of the FDA. It will be important that the food industry, the Regulatory community, NGOs and other interested parties collaborate to ensure that the focus is solely on providing safer products. Utilising a science risk-based approach is how the H.J. Heinz Company guarantees product safety and quality. Leveraging this approach can provide an effective means to prioritise the focus on the highest risk food categories and ultimately reduce food safety issues.

About the authors

Lilia M. Santiago-Connolly is Senior Manager of Food Safety at H.J. Heinz based in Pittsburgh, PA. Previous to this job, Dr. Santiago-Connolly was the QA Manager for a Heinz frozen food factory in San Diego, CA. She received degrees in Animal and Dairy Science and a Master’s degree in Meat Science from Iowa State University, and doctoral degree in Food Science and Technology from the University of Tennessee. She has been working for over 15 years in the field of quality assurance and food safety.

Kurt E. Deibel is the Chief Quality Officer for Heinz North America, a division of the H.J. Heinz Company. In his role, he is accountable for the Quality and Food Safety programs for all products manufactured for Heinz NA. Kurt is also a member of the Heinz NA Executive Committee, the Heinz Global Quality Council and the Tuskegee University Food and Nutritional Advisory Board. Kurt joined Heinz in March, 2010. Prior to Heinz, he held various leadership positions in Food Safety and Quality Assurance with Gerber Products Company, General Mills and PepsiCo. Kurt received his PhD from the Ohio State University in Food Microbiology in 1985. He also earned Master of Science and Bachelor of Science degrees from the same institute. Kurt was also on the Board of Advisors for the following associations / organisations: Center Food Safety (University of Georgia); National Center for Food Safety and Technology; and the National Food Laboratory. He has been very active in food industry Trade Associations (FPA, GMA, ILSI, IFT, etc.) throughout his career. He also has published a number of papers and book chapters in the area of food safety and quality.