Tuesday, October 18, 2016
In early 2011, the Food Safety Modernization Act (FSMA) was signed into law. The FSMA give the Food and Drug Administration (FDA) expansive power to regulate the food supply, including the ability to establish standards for the harvesting of produce and preventative control for food production businesses. It’s the largest expansion of the U.S. food safety law since the 1930s. The FSMA also gives the FDA greater authority to restrict imports and conduct inspections of domestic and foreign food facilities. To implement the requirements of the FSMA, the FDA prepared in excess of 50 rules, guidance documents, reports and studies in short order. Indeed, the timeframe was so short FDA complained that they didn’t have enough time to do the job appropriately. That led to lawsuits being filed by to compel the FDA to issue several rules that were past-due. A federal court agreed in the Spring of 2013, and FDA issued four proposed rules with comment periods ending in November of 2013. One of the most contentious issues involved the rule FDA was to develop on intentional adulteration. FDA claimed it needed two more years to develop an appropriate rule, but the Court ordered them to develop it immediately.
When the 2014 Farm Bill came along it failed to repeal the FSMA. Instead the Farm Bill simply directed the Secretary of the Department of Health and Human Services to conduct an economic analysis of the FSMA when publishing a final rule on “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” Consequently, the FDA issued seven major rules beginning in late 2015 and ending this past May. It appears that the intent of the rules is to focus on the prevention of food safety risks instead of dealing with problems after they occur. The rules also present various practical issues in their application, enforcement, and how they relate to the food supply chain.
Summary of New Regulations
In a nutshell, the new rules, establish a system of preventative controls for facilities that deal with food products (and taxes them to pay for the increased regulatory cost) as well as mandatory safety standards for farming activities involving certain types of farm products – primarily fruit and vegetables (as well as dog food). The rules govern soil and water, hygiene, packing, temperatures and also dictate certain grazing practices of livestock.
While space here doesn’t allow a detailed look at the new regulations, here’s a breakdown of the major provisions:
- The rules establish national standards for on-farm growing, harvesting, packing and storage of domestic and imported produce.
- Covered parties must verify and either provide or receive documentation with respect to food safety risks if they are involved in the food supply/distribution chain and sometimes verification has to be obtained from parties several steps back in the supply chain.
- A covered facility must develop a written food safety plan that identifies hazards that are in need of preventative controls (in addition to any existing Hazard Analysis and Critical Control Plan (HACCP)) to minimize or prevent hazards for food that is manufactured, processed packed or stored at the facility.
- Raw materials or ingredients can only be obtained from an approved supplier, and the burden is on a manufacturer or processor to make sure that the suppliers that they get food products from are following acceptable protocols to make sure that food safety hazards are controlled.
- The preventative controls require food processors to develop and implement written plans that identify hazards that are likely to cause illness or injury based on the severity of any illness that might result and the likelihood that it would occur if the controls weren’t in place; guidance is needed on the severity and probability thresholds. Exempt are seafood or juice processors and some farms.
- Manufacturers and processors must document that they searched the FDA’s public database to make sure that a supplier is in good standing with FDA protocols, and must have procedures in place for receiving raw materials and other ingredients from approved suppliers.
- A written food safety plan must be produced within 24 hours of demand.
- A “produce safety rule” applies to farms that grow or harvest crops or raise animals in one general area, and the rule is expansive enough that it covers cooperatives, on-farm packinghouses, food aggregation and minimal “manufacturing” or “processing” activities, and off-farm packing at “secondary” activities.
- Under the “produce safety rule” a covered farm must inspect and maintain the integrity of its water sources, and take corrective action when necessary, and identify and not harvest produce that is reasonably likely to be contaminated.
- Exemptions exist for “small” farms – defined as those with average annual revenue of less than $25,000 during the previous three-year period, as well as those with average food sales of less than $500,000 annually during the prior three years that sell “predominantly” to “qualified end-users” (restaurants or retail food establishments in the same state or within a 275-mile radius have less stringent requirements imposed).
- Another regulation requires the FDA to implement a program to ensure that imported food is produced in compliance with processes that provide the same level of safety protection that is required of U.S. facilities, and FDA must perform audits to ensure the safety of imported food products.
- Another regulation establishes sanitary rules that apply during transport of food products, and the rules apply to “freight brokers” and “loaders” as covered parties. Basically, shippers will have to communicate their food safety requirements (including operating temperature) to carriers with respect to equipment, operations and training. Written policies will have to be put in place, and carriers will have to document that they are in compliance with the new rules. Failure to do so could result in fines and, perhaps, criminal sanctions. But, the rules don’t apply to transportation activities of entities with less than $500,000 in average annual revenue, and also don’t apply to foods that are entirely enclosed by a container or to certain types of animal foods. USDA facilities are also exempt, and other exemptions apply to relatively smaller businesses.
- There is a “food defense rule” that requires large food companies to come up with plans to assess and manage the risk of intentional adulteration that is intended to cause wide-scale public harm.
- An animal food rule establishes preventative control programs for animal food processors. Again, certain farms are exempt.
The new regulations are generally located at 80 Fed. Reg. 56169 and are contained in 21 C.F.R. Part 117 and various subparts thereof. The sanitary transport rule is contained at 81 Fed Reg. 20091, and mitigation strategies (the Food Defense Rule) are contained at 80 Fed. Reg. 34165. They are generally effective on April 6, 2017, but there are phase-in dates based on business size and other factors that can make the effective date later in certain situations.
While there have been some significant and highly publicized foodborne illness events in recent years, there is no doubt that the U.S. food supply is safe. Indeed, the Centers for Disease Control and Prevention says that the U.S. Food Supply is one of the safest in the world. However, the Administration directed the FDA to significantly expand regulations on farmers, shippers, packers, manufacturers and others in the food supply chain. I can’t find where any cost-benefit analysis was engaged in to determine whether the additional cost that will ultimately be imposed disproportionately on consumers, small farms and local food producers is justified economically. I also can’t find that the government had any evidence that the rules would actually address a major problem with food safety and reduce illnesses caused by food. Only time will tell whether the increased regulation of food production activities actually accomplishes anything other than subjecting the food production chain to further regulations.