By Stephen Phelan
This chapter deals with the provisions of FSMA that are most likely to require computer systems for full compliance, especially software programs. In Chapter 3, we will deal with what specific software is likely to be most useful, while this chapter lays out the broad requirements of the law.
When the Food Safety Modernization Act went into effect in January, 2011, the regulatory role of the Food & Drug Administration changed radically in nature. Prior to FSMA, the FDA was mostly in reactive mode – something terrible had to happen before they could do very much, and even then their powers were quite limited. Now, the emphasis has shifted to prevention, and the FDA has broad new powers to avoid trouble in the first place.
Among FSMA’s mandates:
- Federal/State integration: FSMA envisions an Integrated Food Safety System, where the federal, state, local, tribal and territorial agencies work in concert to strengthen inspection, laboratory and response capabilities, for both human and animal food.
- Inspection and compliance tools: In addition to mandated food facility inspections, the FDA will have broad access to records, and will require accreditation of outside laboratories to perform certain food testing.
- Product Tracing: The FDA will establish rules to enable the tracing of food materials in the food chain, especially of high-risk products.
- Importer Accountability: Importers will now be responsible for the safety of their imports, and the FDA will establish testing and certification programs to ensure that imports are safe. In particular, the FDA now has the authority to turn back imports if it is denied access to foreign facilities.
- International Capacity Building: Working with the appropriate governmental and private stakeholders, the FDA will develop plans to expand technical, scientific and regulatory capabilities of foreign food manufacturers who export to the US.
- Fees: Substantial new fees and penalties are authorized by FSMA to fund some of the new activities. These fees will escalate rapidly for non-compliant companies.
- Prevention: FSMA is prevention-oriented and science-based. The Act establishes mandatory preventive controls for food facilities, and mandatory produce safety standards, including for safe harvesting of fruits and vegetables.
- Small Business: Because many food growers and producers and small businesses, FSMA contains specific provisions and exemptions to help small companies comply with the new law.
Computer software will be needed to comply with the upcoming mandates. Since most of these regulations are currently tied up in the Office of Management and Budget for review, it is difficult to know exactly where the burden is likely to fall and what to plan for. Still, it is possible to see the broad outlines of which systems may need enhancement.
These mandates include the requirement that all food facilities have written control plans to:
- Evaluate food safety hazards
- Detail preventive steps and controls
- Specify how to monitor controls to ensure that they are working
- Maintain routine records
- Specify corrective action if problems arise
These provisions are all about creating and executing control plans, and documenting what you have done. Other mandates require inspections by third-party laboratories. When the FDA arrives for a routine (and free) inspection, therefore, you want to be sure you can produce records demonstrating compliance with the rules. You do NOT want to have the FDA return for a re-inspection – the agency has made it very clear that re-inspections will be expensive. So you need to be certain that you can produce the necessary information quickly and accurately. We don’t yet know exactly what details will be required, be we can be pretty sure that you will need good analytical systems to pull whatever data is needed.
The FDA must establish science-based minimum standards for the safe production and harvesting of fruits and vegetables and issue regulations to prevent intentional and unintentional contamination, including mitigation strategies. FSMA also establishes minimum requirements for plant inspections, both domestic and foreign, and gives the agency full access to the records mentioned above and others affecting food safety. In addition, FSMA directs the FDA to establish accreditation programs for food testing laboratories and requires certain food testing to be done only by accredited laboratories.
When food problems emerge despite preventive controls, the FDA has the power to:
- Issue mandatory recalls
- Administratively quarantine suspect food products
- Suspend the registration of a facility
- Track and trace both domestic and imported food
- Require additional record keeping for high-risk foods
Of these requirements, the one most likely to require software is clearly the tracing provision, so much so that FSMA has built-in provisions for a tracing pilot program. Relatively few companies can adequately trace incoming materials through the various manufacturing steps. Tracing should provide the FDA with the means to start from any suspect lots of material, and trace them backwards and forwards in the food chain to identify both the source of the problem, and exactly where everything went, making product recalls easier and less burdensome. The main issue here is that speed is of the essence – some food contamination is very dangerous indeed, so identifying and tracing the problem saves lives, literally. The tracing problem is compounded when some foodstuffs are imported, when some are co-packed off site, when bulk materials are packaged into handling units, when some materials are reworked or blended … there are layers of complexity to make adequate tracing difficult. Every company in the food chain should be planning now how they will meet FSMA’s track and trace requirements.
Another provision of FSMA has to do with foreign food manufacturers whose products are imported into the United States. Enforcing US regulations has always been unpopular because (among other things) manufacturers believed that it put them at a competitive disadvantage with respect to foreign importers, who did not have to adhere to strict rules in their production facilities. FSMA effectively gives the FDA the same regulatory powers over foreign producers as they have over domestic producers, simply by giving the FDA the authority to turn away products at our borders if the manufacturers have not given the FDA the same inspection access as they have domestically. Practically speaking, the FDA can close the US market to any foreign manufacturer who fails to comply with FDA requirements. This has the effect of leveling the playing field, and is probably the provision that got FSMA through the legislative process with such apparent ease. Of course, the publicity about melamine in milk products and adulterated pet foods didn’t hurt either. But extending the reach of FSMA to foreign manufacturers was both effective in regulatory terms and popular in political terms.
In the next chapter of this blog, we will look at how software can help manufacturers meet the regulatory burdens that FSMA imposes, but with the expectation that compliance can actually reduce costs and improve productivity.