Introduction Genetically engineered (GE) foods continues to be a topic of public interest. Other names for genetically engineered foods that you may hear include “genetically modified foods” or GMO, “Biotech”, and “bioengineered” foods. The FDA uses the term genetically “engineered” to differentiate it from other methods that can also result in genetic modification such as cross-breeding […]
This rule establishes regulations for the safe handling and transport of human and animal food. Foods that fall under this rule include bulk foods, foods not enclosed by a container (e.g. fresh produce) and foods that require temperature control for safety. The rule only covers shipment by motor vehicle or rail. Shipments that are exclusively […]
Recognizing the vulnerability of the food supply to intentional adulteration, Congress has determined that rules be established to prevent it from happening. Under the rule for mitigation strategies to protect against intentional adulteration, food companies are required to establish a food defense plan similar to the HACCP approach. The defense plan must include the following key […]
Under this rule third-party auditors will be established as Certifying Bodies (CBs) to conduct food safety audits and issue certificates to foreign facilities and foods. The audits may be either regulatory or consultative. Summary of How the Program Works The FDA recognizes an Accrediting Body (AB) The AB accredits qualified third-party CBs The CBs audit […]
The foreign supplier verification program (FSVP) was established to ensure that imported foods meet the same high standard of safety as is required by foods produced domestically. This is important since the United States is a huge importer of foods from over 150 countries and 275,000 facilities from around the world representing about 15% of […]
Before FSMA, only a few food companies were required to have a food safety management plan by the FDA. These include manufacturers of juices and seafood, as well as low-acid canned foods (for biological hazards only). Under FSMA, all food processing operations (with some exceptions) will be required to establish a food safety plan. This […]
FSMA’s produce safety rule was established to improve food safety of raw produce for human consumption. The majority of foodborne illnesses are caused by agricultural commodities consumed raw. Therefore by providing oversight, the FDA now has control of the majority of the food supply from farm to fork. The rule addresses six key areas, (1) […]
The Food Safety Modernization Act or FSMA was signed into law by President Barack Obama on January 4, 2011 as a move to overhaul the food safety system in the US. The law would take an all-encompassing approach to food safety from the farm through processing, and would include controls to prevent intentional adulteration of […]
The justice system in the United States prosecutes corporate officers such as CEOs in criminal or civil cases based on “strict liability”. Strict liability is the principle that the officer is responsible for the crime regardless of knowledge of wrongdoing or intent to do wrong. This principle was derived from the Dotterweich Doctrine (1943) and […]
