The U.S. Food and Drug Administration has finalized rules to implement the Food Safety Modernization Act. This Act establishes enforceable safety standards for produce farms and makes importers accountable for verifying that imported food meets U.S. safety standards. The rule also establishes a program for the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits of foreign food facilities.
The purpose is to help produce farmers and food importers take steps to prevent problems before they occur. Prevention – rather than treatment.
The U.S. Centers for Disease Control and Prevention estimates that 48 million people (1 in 6 Americans) get sick each year from foodborne diseases. Approximately 128,000 are hospitalized and 3000 die each year. The new program is referred to as the Produce Safety rule, the Foreign Supplier Verification Program and the Accredited Third-Party Certification.
The Produce Safety rule – establishes science-based standards for growing, harvesting, packing and holding produce to provide food safety across the broad variety of produce farms. The standards include requirements for water quality, employee health and hygiene, wild and domesticated animals, biological soil amendments of animal origin (compost and manure) and equipment, tools and buildings. The rules are to help minimize the risk of serious illness or death from consumption of contaminated produce.
Foreign Supplier Verification Program rule – requires food importers to verify that foreign suppliers are producing food in a manner that meets U.S. safety standards and that they are achieving the same level of food safety as domestic farms and food facilities. (In 2013, USDA estimated that imported food accounted for about 19 percent of the U.S. food supply, including about 52% of the fresh fruit and 22 % of the fresh vegetables consumed by Americans.) Importers must conduct verification activities, such as audits of a supplier’s facility, sampling and testing of food, or a review of the supplier’s relevant food safety records, based on the risks linked to the imported food and the performance of the foreign supplier.
Accredited Third-Party Certification rule – establishes a program for the accreditation of the third-party certification bodies (auditors) to conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meets applicable FDA food safety requirements. The FDA can require in specific circumstances that a food offered for import be accompanied by a certification from an accredited third-party certification body.
The law also grants FDA mandatory recall authority.
An amendment to the bill offers protections for operations (a.k.a. “qualified facilities” that make less than $500,000 a year and sell most (greater than 50%) of their products directly to consumers in the same state and within a 400-mile radius. It also applies to all operations that the FDA classifies as “very small business”. Thus small, local farmers would not necessarily need to comply with some of the requirements and produce safety regulations. Instead these small-scale producers (like those who sell their goods at farmers’ markets or roadside stands) would continue to be regulated by local and state entities. In addition, consumers would know whom they are buying from either by direct sales or clear labeling. Farmers who qualify must provide documentation that the farm is in compliance with state, local, county or other applicable non-Federal food safety law. The farm must prominently and conspicuously display the name and address of the farm/facility on its label or if no label, then by poster, sign or placard at the point of purchase or in the case of Internet sales, in an electronic notice, or in sales at stores and restaurants, on the invoice.
The law requires producers and importers to pay an annual fee to help with the costs of implementation.
The FDA will now have a legislative mandate to require use of their controls across the food supply, including pet food and animal food. The FDA can recall food in the case of contamination or illness. It can require farms to track their food and have and implement plans to deal with recalls or outbreaks of disease and they will be given access to food growers records in the case of an outbreak.
Importers have the responsibility to verify that their foreign suppliers have adequate preventive controls to ensure that their food is safe. The FDA has the authority to require that high-risk imported foods be accompanied by a credible third party certification or other assurance of compliance of entry into the U.S. FDA can refuse entry into the U.S. of food from a foreign facility if FDA is denied access by the facility or the country.
All of this will cost money. The Congressional Budget Office (CBO) estimates that to implement the program the FDA will need an increase in its base funding for food safety of $583 million over the first five years. It is estimated that FDA will need an increase of $109.5 million for FY 2016 to move forward to implement the program.
Concerns regarding the program include the cost to implement and run the program. Many say there are already programs in place to protect our food supply. And virtually, within the States, we do a very good job of feeding a nation of people, with healthy and wholesome food.
Many state that the spending of thousands of dollars, hundreds of hours and the endless meddling of government bureaucrats, is an opportunity to “grow government”.
Many state the endless amount of paperwork and records required by the government, is taking precious time and money from producers to meet the government demands.
Many say they will go out of business due the unnecessary work and costs. This, in turn, will necessitate that even more food will be imported and imported from countries where even the tap water is unsafe to drink.
Others say that the government cannot keep-up with their work, now in various agencies, how will they be able to monitor food “smuggled” brought in from other countries.
Producers and food industry persons want our food to be safe. They have no desire to offer food that may cause illness or harm and they have many personnel, presently, in their employ to check food handling to provide safe food and believe that the new regulation will take away from their current efforts of monitoring facilities and equipment to be able to do the additional paperwork. Also the additional costs will require an increase in the cost of the food.
Sometimes when we try to fix a problem, we create many additional problems. The law is here, how can we work with it?
FDA Food Safety Modernization Act, Wikipedia
U.S. Food and Drug Administration, FDA News Release, November 2015.
Taylor, Michael, Food Safety News. The Future is Now for the Food safety Modernization Act, March 17, 2015
Also see: in this Blog – www.foodcrumbs.com
- Vacuum Cooling of Produce, 11/28/ 2012
- Lettuce – Harvesting, Storing, & Transport, 10/31/2012
- Food Transport – 10/31/2009