Elizabeth Fawell and Steven Steinborn, Hogan Lovells US LLP
On January 4, 2011, President Barack Obama signed into law historic food safety legislation--the FDA Food Safety Modernization Act (FSMA). The law has two major themes: prevention and accountability. Prevention means that food companies need to have controls in place during manufacturing to assure the safety of their products and to prevent problems (not just react to them after-the-fact). Accountability means that food companies are accountable to the Food and Drug Administration (FDA) to help ensure that not only their own facilities, but also their suppliers, are making safe food.
Although the law primarily has significant implications for food manufacturing facilities, importers and the fresh produce industry, it also affects those individuals responsible for creating and developing new products. There are two major provisions in FSMA that are particularly relevant to food product developers: Preventive Controls and the Foreign Supplier Verification Program. In brief, the new responsibilities imposed by FSMA mean that companies will need to sufficiently plan ahead and bring together cross-functional teams as they develop new products.
The Preventive Controls provision is found in Section 103 of FSMA (Federal Food, Drug and Cosmetic Act (FFDCA) Section 418). It requires all registered food facilities 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 and provide assurances that the food is not adulterated and does not contain any undeclared allergens. The hazard analysis, preventive controls, monitoring efforts, corrective actions, and verification activities (including product and environmental testing), all must be documented as part of a “food safety plan.”
Many facilities already have such food safety plans. However, now those plans are required as a matter of law. In addition, it is important to keep in mind that the requirement to have a food safety plan applies to all facilities required to register under the Bioterrorism Act. Most research and development (R&D) facilities are registered with FDA because they handle food for human or animal consumption (even if just under test conditions). As result, these facilities will need to develop food safety plans, too.
This can pose particular challenges given the ever changing nature of the food products produced at such facilities and the dynamics of the product development process. At this time, it is unclear how FDA will treat such facilities in the regulations implementing this section of FSMA. Regardless, it is a good idea for those individuals involved in product development to meet with individuals from quality assurance and regulatory to start thinking about how to develop food safety plans for R&D facilities. And the product development team will need to stay in close contact with individuals from quality assurance to help ensure that the food safety plan for the R&D facility is updated when development of a new product commences. This may mean building in extra time into the product development process so that the food safety plan is in effect before production begins.
However, under FSMA, the most important role that the product development team must play is to think ahead about how to ensure the safe production and distribution of any product it develops. That means thinking about which preventive controls will be needed at the manufacturing facility and whether potential hazards can be “designed out” in the first place. In other words, asking the question: how can the product be designed so as to eliminate potential hazards downstream? To answer this question, it makes sense to consider whether additional individuals should be part of the product development team, such as personnel from quality, microbiology, the manufacturing facility, etc. A cross-functional team can brainstorm about issues such as which preventive controls, monitoring activities, and testing programs are needed; whether those activities are achievable; and whether certain controls would be rendered unnecessary by how the product is designed and made.
Although it does require additional resources up front, by bringing many individuals with complementary expertise to the table early on, safety can be built into the product. Not only will this help ensure safer food products, but it also will help anticipate and address potential food safety risks before substantial resources are committed. Additionally, the collaborative development approach has the potential to enhance the potential success of product development projects because food safety “surprises” are less likely to arise late in the process. In all, there are great benefits to building food safety into the product development process.
Supply Chain Management
As noted above, another major theme of FSMA is accountability. Specifically, in addition to placing responsibility on food companies to ensure the safety of products they themselves manufacture, FSMA also places additional responsibilities on food companies to ensure that their suppliers are making safe ingredients as well. It does this in two ways. First, one of the preventive controls that registered food facilities will need to have in place is a supplier verification program. Second, there is a major provision in FSMA called the Foreign Supplier Verification Program (FSVP) (FSMA Section 301; FFDCA Section 805). This provision applies to all importers of “food” and requires importers to perform risk-based verification activities to ensure that the food they import is produced in compliance with the Preventive Controls or Fresh Produce provisions (if applicable) and is not adulterated or contain any undeclared food allergens. As a result of both provisions, food companies will need to exercise greater oversight over their suppliers (domestic or foreign). This new responsibility also will affect product development.
The good news is that small quantities of food imported for research and evaluation are exempt from FSVP. Therefore, companies will not need to develop verification programs when evaluating potential suppliers as part of the product development process. Nonetheless, any supplier chosen to provide an ingredient will need to be subjected to a verification program, and the food company will need to exercise careful oversight to ensure that the ingredients it receives are safe.
The statute gives a “starter list” of potential supplier verification activities. These include monitoring shipment records, periodically testing shipments, and reviewing the food safety plan of the supplier. In addition, it is expected that third party certification by accredited auditors, as well as direct on-site audits by food companies themselves, will play important roles in supplier verification activities.
Because of the resource intensive nature of a supplier verification program, some food companies may ultimately decide to use only “approved” suppliers. That may mean less flexibility in sourcing ingredients for the product development team. It will certainly mean that individuals involved in product development will need to work with the supply chain management team when developing new products to ensure that necessary ingredients will be available from approved suppliers. So again, the product development team may need to build extra time into the development process and will need to work in conjunction with other functions within the company.
Ultimately, the enactment of FSMA means that big changes are coming for food companies everywhere. The product development team has a key role to play in helping any company meet its new prevention and accountability responsibilities. Companies may need to build more time into the product development process, but in the end, such an effort can help ensure safer products for consumers.