One of the most highly debated and complex new pieces of legislation regarding food products will be finalized late in the coming weeks.
The Food Safety Modernization Act (FSMA) proposes new rules that govern both on-farm and off-farm food growing, handling and processing. The aim as implemented by the Food and Drug Administration is to reduce food-borne illness and the risks of bioterrorism through contaminated food supplies.
The act encompasses preventative controls, inspection, compliance, food import oversight and recalls.
The act is broken into two parts – the Preventive Controls Rule, which will be finalized Aug. 30, 2015, and the Produce Rule, to be finalized Oct. 31, 2015.
Once the rules are published in the Federal Register, they will go into effect 60 days later. However, compliance with the laws is staggered, allowing the smallest companies additional time to comply.
The Preventative Controls Rule affects companies that, “manufacture, process, pack or hold food for consumption in the United States.” The first threshold is whether a company’s operations classify them as a facility, an area that needs to be further defined for small farms.
Retail food operations are exempt, for example, grocery stores or restaurants. If a company is deemed to operate a facility, they must create and implement a written food safety plan. Components of the plan include hazard analysis, preventative controls, supplier program, monitoring procedures and corrective actions.
Verification of implementation and effectiveness are required.
Although many food manufacturers already have food safety procedures in place, the new law includes new requirements for hazard analysis and risk-based preventive controls (HARPC) and revisions to existing Current Good Manufacturing Practice (CGMP) requirements. Facilities with rules already in place – seafood, juice, alcohol and low acid canned goods – are exempt.
Staging for implementation of this rule is within one year for most companies, two years for small companies (fewer than 500 employees), and three years for very small companies (under $1 million in sales of human food).
The Produce Rule applies to the growing, harvesting, packing and holding of produce generally consumed raw. The proposed rules set standards regarding water used for agriculture, animal-origin soil admendments, health and hygiene, wild and domesticated animals, and equipment, tools and buildings. Farms will have two to four years to comply with these rules, depending on sales.
The water standard has additional years built in for compliance. If average farm sales for the past three years were under $25,000, then compliance is not required. The end use of produce grown, i.e., if it receives further processing, affects the level a farm must comply with the rules.
FSMA also affects food importers. Those who purchase imported goods must verify that suppliers used “reasonably appropriate risk-based preventative controls” in growing, processing and handling the product.
Depending on how that rule is applied and the requirements for foreign vendors could have a major impact on the availability of imported food. The import rule will affect retail operations since they will need to ensure imported food meets requirements.
Those impacted by the new law will have a considerable investment of time and money for training, plan development and implementation. In addition, auditing and monitoring activities are conducted both internally and by external third parties.
Organizations such as the National Sustainable Agriculture Coalition are working to help small farms and businesses understand and implement the new rules. For more information, the FDA’s FSMA site is www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm.