The Food Safety Modernization Act and its relevance to the oilseed industry
By Bryan Yeh
On January 4, 2011, US President Barack Obama signed into law the Food Safety Modernization Act, known as FSMA. This act is a significant overhaul of the Federal Food, Drug, and Cosmetic Act that was enacted in 1938. Since that time, we have seen our population grow and become more diverse, we have a greater awareness of foodborne illness, we have a larger variety of foods, and we have increased the importation of food into the United States. The intent of this act is to improve food safety in the United States by focusing on four themes: (i) prevention; (ii) inspections, compliance, and response; (iii) import safety; and (iv) enhanced partnerships.
Motivation for the new law
Consumers in the United States spend over $1.1 trillion on food annually, making food a major economic driver. However, foodborne illness is a significant burden, resulting in 48 million people getting sick each year (one in six Americans). Of these, 128,000 are hospitalized and 3,000 die (Taylor, 2011); some face long-term consequences, such as arthritis or kidney failure. Individuals with reduced immune capacity, such as infants, children, pregnant women, the elderly, and those on chemotherapy, are especially vulnerable. All told, Belden and Orden (2011) estimated that over $150 billion is spent annually on food-related illnesses in the United States alone.
The United States imports 15% of its food. Some foods are imported in significantly higher proportions than others. For example, 20% of all vegetables, 50% of all fruit, and 80% of all seafood consumed in the United States are imported (Taylor, 2011). All of these foods have short shelf lives, which increases their risk of spoilage. The E. coli outbreak that occurred in Germany during the summer of 2011 as well as contamination issues involving food from China has increased awareness about the need to monitor the safety of imported foods.
At the same time, our food supply chain is more complex than ever before. As a greater variety of foods, including ethnic foods, processed and prepared foods, and new ingredients such as low-calorie sweeteners and flavors, are made available, the steady stream of new products entering the market needs to be addressed as part of an overall food safety initiative.
The core focus of FSMA is preventing incidents as opposed to reacting to them. The act provides a legislative mandate for the Food and Drug Administration (FDA) to require comprehensive and prevention-based controls across the entire food chain. Food facilities are defined as locations that manufacture, process, pack, or store food and include food manufacturers, processors, and retailers such as grocery stores and restaurants. Specifically, the law requires that food facilities:
- Develop a written analysis of hazards that are “known or reasonably foreseeable” in their operations and implement the appropriate controls to prevent unintentional as well as intentional contamination. These potential hazards include biological and chemical hazards, foreign material, decomposition, natural toxins, pesticides, and unapproved additives.
- Identify and implement preventive controls to “significantly minimize or prevent” identified hazards. Within the law, preventive controls are defined as “risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ.”
- Monitor the effectiveness of the preventive controls to determine whether the desired outcome is achieved.
- Take appropriate corrective action to rectify failures if/when it is determined that preventive controls are not appropriate.
- Develop and implement a written food safety plan that documents and describes the procedures used to comply with FSMA. This plan will need to be readily available upon request by the FDA.
- Reanalyze the plan at least every three years or sooner if a change is made at the facility that could result in a “reasonable potential” for introduction of a new hazard, or if there is a significant increase in the risk of a previously identified hazard.
FSMA does provide for some exemptions to its requirements; however, these are restricted to farms generating less than $500,000 in annual income from food or to a “qualified end user” such as the food consumer.
FSMA also has a section that addresses intentional adulteration. In addition to the requirement identified above, the law mandates that the FDA coordinate with the Departments of Homeland Security and Agriculture to promulgate regulations to protect against intentional adulteration. These regulations, which are still pending, will be applicable to “high-risk” products, specifically those with short shelf lives or susceptibility to intentional contamination at critical control points, as well as products that are in bulk or batch form prior to being packaged for the final consumer.
Inspection, compliance, and response
FSMA requires the FDA to use a risk-based approach toward setting inspection frequency. This will allow the FDA to be efficient and effective with its existing resources. Specifically:
- Domestic high-risk facilities shall be inspected once in a five-year period following the enactment of FSMA and not less than every three years thereafter.
- Domestic non-high-risk facilities shall be inspected once in the seven-year period following the enactment of FSMA and not less than every five years thereafter.
- Six hundred (600) foreign facilities shall be inspected in the one-year period following the enactment of FSMA; and in each of the five years following the initial one-year period, the FDA shall inspect not fewer than twice the number of foreign facilities inspected by the FDA in the previous year. In other words, the law requires the FDA to double its resources every year for the inspection of foreign facilities.
FSMA also increases the authority of the FDA with regard to food safety compliance and response. Specifically, FSMA authorizes the FDA:
- To issue mandatory recalls if there is a “reasonable” probability that an article of food (other than infant formula) is adulterated or misbranded and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals and if the responsible party declines to cease distribution and recall such article.
- To access all existing facility records relating to an article of food whose use, or exposure to, is likely to have a reasonable probability of causing serious health consequences or death to humans or animals. Access is limited to records having to do with the manufacture, processing, packing, distribution, receipt, holding, or importation of such article by the responsible party.
- To detain an article of food administratively when there is “reason to believe” that it is “adulterated or misbranded.”
Under FSMA, all domestic and foreign facilities that manufacture, process, pack, or store food are required to register with the FDA under the Bioterrorism Act of 2002. Similarly, FSMA authorizes the FDA to suspend the registration of a facility if it determines that food manufactured, processed, packed, received, or held at the facility has a “reasonable probability” of causing serious adverse health consequences or death to humans or animals. This action ultimately results in the shutting down of the facility if it is located in the United States. For foreign facilities, it will result in the food from that facility being refused entry into the United States.
As discussed earlier, an increasing amount of food consumed in the United States is imported, much of which is in the “high-risk” category. FSMA provides significant enhancements in the FDA’s ability to provide greater oversight of imported food. The practice of relying on port-of-entry inspection is being shifted toward having importers responsible for ensuring that their foreign suppliers have adequate preventive controls in place. The intent is to have the food supply from abroad be as safe as the domestic food supply. Some of the important mandates related to import safety are as follows:
- FSMA requires that importers verify that their suppliers use risk-based preventive controls that provide the same level of protection as US requirements.
- FSMA provides for the expedited review and importation of food offered for importation by importers who participate in a voluntary supplier importer program.
- FSMA grants the FDA the authority to require assurances of compliance for high-risk foods.
- The FDA can deny entry of food from facilities that deny FDA access for inspection.
- The FDA can rely on accredited third parties to certify that foreign food facilities meet US requirements. This step will facilitate the ability of importers to participate in the voluntary qualified importer program, as well as provide assurances for the safety of high-risk food.
To facilitate the requirements for import safety, the FDA has a mandate to work with foreign governments to build their food safety capacity. This will allow the FDA to rely more heavily on foreign government oversight and prevent problems before the products reach the United States. In addition, the FDA will establish offices in foreign countries to provide assistance on food safety measures for food exported to the United States.
Enhancing food safety will also require partnerships between different US agencies. Although the FDA has jurisdiction over approximately 80% of the food supply, the Department of Agriculture has jurisdiction over the other 20%, which includes meat and poultry. Furthermore, the Department of Homeland Security handles matters involving intentional adulteration of food. Hence, FSMA sets the expectation that the different agencies will work together with a common goal of improving the country’s food safety.
When an adulteration event occurs, the cooperation of state and local agencies will be necessary. Performing surveillance, attribution, and analysis will also require the joint effort of laboratories throughout the country. The requirements for these partnerships are outlined in FSMA.
Bryan Yeh is an assistant vice president for Science Applications International Corp. (SAIC) and leads the biofuel initiative, food safety, food defense, and food security programs within SAIC. He is based in Oakland, California, USA, and can be reached at firstname.lastname@example.org or +1 510-466-7190.
Relevance to the oilseed industry
Although the oilseed processing industry has enjoyed a good record with respect to food safety, there have been several incidents from analogous manufacturing from which we can learn.
- In 2005, a large US ice cream retailer recalled ice cream that had raw cake batter included in the mix. The cake batter, which was not cooked, contained flour that was contaminated with salmonella.
- Between 2008 and 2009, peanut butter, peanut paste, and peanut products containing salmonella were shipped from a plant in Georgia. This resulted in the largest food recall in the nation’s history and the bankruptcy of a major peanut processor.
In response to a request for comments from the FDA, the National Oilseed Processors Association listed several process controls that eliminate or reduce to acceptable levels the potential hazards that are associated with oilseed products:
- Restricting access to critical plant areas.
- Keeping vegetable oil in a closed system, free of contamination.
- Using elevated temperatures during processing to reduce the number of microbial organisms that may be present.
- Putting in place pest control programs.
- Securing hazardous chemicals and lubricants.
- Using common carriers who employ procedures to ensure that prior loads are compatible with food/feed ingredient products being shipped.
- Inspecting rail and barge cargo compartments for prior cargo and cleanliness.
- Using railcar sealing best management practices for crude vegetable oil.
- Following truck cleaning requirements and requiring truck drivers to certify that no prohibited mammalian protein was present in prior loads.
- Training employees on product safety and operating parameters.
- Using FDA-recommended recall procedures and implementing event-reporting procedures.
- Maintaining records for processing, maintenance, and inbound and outbound product shipping to support one-step-forward, one-step-back tracing.
- Sampling, grading, and visually inspecting inbound oilseed shipments for contamination.
- Following supplier-certified safety/purity requirements for meal flowability additives.
Although oilseed processing facilities are considered as “food” plants and are therefore covered by FSMA, it is expected that oilseed plants will fall under the “non-high-risk” category owing to the limited risk of these products. The implication is that some of the mandates that are triggered by the “high-risk” food threshold will probably not need to be addressed. Despite the “non-high-risk” status of the industry, FSMA’s focus on prevention is appropriate for the industry. As many of the processors have already adapted preventive measures, we should expect that the oilseed industry will continue to set a good example for food safety in the future.
New food regulations in India
In August 2011, India’s comprehensive Food Safety and Standards Act (FSSA) came into effect. The new act, passed five years ago, replaced the previous patchwork of safety laws with one set of rules that apply to all food products and food handlers.
The new rules regulate the production of food from farm to fork and involve government testing of agricultural produce and imported food; the mandatory registration and licensing of all food operators and vendors, including street vendors; strict hygienic procedures for processing, storing, supplying, and purchasing food; monetary penalties for breaking the rules; and parameters for acceptable fat content in foods.
The FSSA has also established a single reference point for all matters relating to food safety and standards, by moving from multilevel, multidepartmental control to a single line of command. Now, one independent statutory authority—the Food Safety and Standards Authority of India based in Delhi—will set science-based standards for articles of food destined for human consumption and will regulate its manufacture, storage, distribution, sale, and importation.
The government has increased the number of state testing laboratories and appointed more food safety officers to police food quality and hygiene as opposed to just monitoring adulteration. Meanwhile, The Times of India reported on October 20, 2011, that according to a study by the Confederation of Indian Food Trade and Industry and the Federation of Indian Chambers of Commerce and Industry, about 30% of those engaged in the food industry were unaware of the FSSA. However, 75% of the respondents who knew about the act felt there was “a need for harmonization of food regulations in the country with internationally accepted standards.”
• Belden, C., and D. Orden, Review of the FDA Food Safety Modernization Act (FSMA): What it means, where it is headed, and why it matters, GII [Global Issues Initiative] Working Paper No. 2011-3, Virginia Polytechnic Institute and State University (Virginia Tech), Arlington, Virginia, USA, September, 2011, 27 pp.
• Taylor, M.R., Will the food safety modernization act help prevent outbreaks of foodborne illness? N. Engl. J. Med. 365(9):e18 (2011); doi 10.1056/NEJMp1109388.