Food safety, certification programmes, animal safety and disease
Primary processors in the United States are subject to legislation governing their methods of treatment and slaughter of live animals. The Humane Methods of Slaughter Act (HMSA) governs the slaughter process itself. The HMSA enjoys some pre-emptive power over the states and is enforced by the US Department of Agriculture (USDA). Importantly, the HMSA does not apply to poultry slaughter.
Another principal piece of legislation in this area is the Federal Meat Inspection Act (FMIA). The FMIA confers broad authority onto the Food Safety and Inspection Service (FSIS), a federal agency within the USDA, to implement and enforce thorough inspection criteria for food processors. The FMIA applies to slaughterhouses that transport their products across state lines. A supplemental piece of legislation, the Wholesome Meat Act, requires all states to have intrastate inspection programmes ‘equal to’ that of the federal government. These laws work in tandem to create a national scheme of health and safety governance applicable to primary processors of most live animals. Relatedly, the Poultry Products Inspection Act (PPIA) imposes safe and humane slaughter and processing of poultry products.
Different statutes regulate the safety and labelling of meat and poultry at the federal level. The FMIA and the PPIA regulate the production, safety and labelling of meat and poultry products, respectively, with few exceptions. Under the FMIA and the PPIA, and their implementing regulations and policy statements, the FSIS broadly regulates nearly all aspects of the harvest, processing and labelling of meat, poultry and certain egg products regulated under the Egg Products Inspection Act (EPIA).
Two important concepts run through these regulatory schemes: adulteration and misbranding. Adulteration is the standard for food purity and safety, broadly defining which food products meet regulatory requirements and are safe for consumption. Misbranding relates to whether the labelling of a food meets regulatory requirements. The FSIS regulations, policy memoranda and the Food Standards and Labelling Policy Book provide additional labelling requirements and guidance for meat and poultry products.
Most food products are regulated under the Federal Food, Drug and Cosmetic Act (FDCA) administered by the Food and Drug Administration (FDA). Whole eggs in shells are regulated under the FDCA but other egg products are regulated under the EPIA, administered by the FSIS. Animal feed and pet food are also regulated under the FDCA as are dietary supplements, medical foods and infant formula, but with some additional requirements. Alcohol products are almost entirely regulated under the Federal Alcohol Administration Act, administered by the US Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau. Organic food products are regulated under the Organic Food Production Act, administered by USDA.
The Food Safety Modernization Act (FSMA) imposes numerous food safety requirements on food companies, including a mandate that companies that manufacture, pack or hold food develop written food safety plans. These food safety plans include, among other things, a hazard analysis to identify reasonably foreseeable hazards to humans or animals and controls to minimise or prevent those hazards.
The FSMA arms the FDA with enhanced monitoring and enforcement powers, including the authority to issue a mandatory recall when there is ‘reasonable probability’ that a food is adulterated or misbranded and will cause serious adverse health consequences or death to humans or animals. The FDA rarely uses its recall power, instead using public announcements and other means to encourage a company to issue a voluntary recall. The FDA can suspend a facility’s registration, seize and detain food, and impose both civil and criminal liability for individuals or corporations that sell adulterated or misbranded products.
Regarding meat, poultry and eggs products, the FSIS has similar legal authority to take administrative, civil or criminal enforcement actions against individuals and companies for violations of the FMIA, the PPIS and the EPIA. These actions can include detention of products when there are insanitary conditions at a facility or inhumane slaughter or handling. Recalls are initiated by the manufacturer or distributor. At times, the FSIS recommends a company initiate a recall, but all recalls are voluntary. If a company refuses to initiate a voluntary recall, the FSIS has the legal authority to detain and seize those products in commerce. The FSIS can also stop facility production, seize product, file an injunction and seek civil or criminal penalties.
Product certification
In the United States, third-party certifying organisations establish adherence to certain voluntary standards, such as organic certification and labelling and labelling products as ‘non-GMO’. Organic certification verifies that the company complies with USDA organic regulations and allows certified companies to label, market and sell products as organic.
Bioengineered foods are regulated by the USDA under the National Bioengineered Food Disclosure Standard of 2016. All bioengineered foods or foods containing bioengineered food ingredients must bear specific labelling by 1 January 2022. The bioengineering disclosure requirement does not address foods that claim to be ‘non-GMO’; this is a claim usually made with certification from a third party that the food is ‘non-GMO project verified’.
Food labelling requirements
Federal jurisdiction over food labelling is divided between two key agencies: the FDA and the USDA. The FDA governs most foods sold in the United States under the FDCA. The FDCA requires five mandatory label elements: product name; net contents; nutrition fact panel; ingredient list; and name and place of the manufacturer or distributor. Health claims (statements regarding how foods affect the ‘structure and function’ of the human body) and claims such as ‘light’, ‘fewer calories’, ‘less fat’, ‘fresh’, ‘bioengineered’, ‘pasteurized’, ‘organic’, ‘allergens’ and others are found in FDA regulations, guidance documents and compliance policy guides. In many cases, these regulations establish minute details of how text may appear on a label, including font size and placement.
Labelling of meat, poultry and certain egg products is regulated by the USDA’s FSIS. In contrast to products regulated by the FDA, labels for these products must be preapproved by the FSIS.
Labelling compliance is important; if the label fails to meet regulatory standards, the food may be characterised as ‘misbranded’ and subject to government enforcement actions ranging from warning letters to product recalls to product seizures. Misdemeanour or felony criminal penalties are also possible. However, perhaps the most discussed enforcement development in the last decade has been the growing trend of consumer class action lawsuits seeking substantial damages for labelling transgressions, both real and perceived.
The FSMA establishes robust, proactive food safety measures across the spectrum of industries that market food products to the public. It imposes safety and control requirements on the production of animal food, including food provided to food-producing animals, such as cattle and poultry.
A framework of federal statutory, regulatory and decisional law governs the transportation of food animals. For example, food animals’ health is protected during transportation by the ‘28 Hour Law’. Additionally, state negligence law often sets the standard for protecting food animals from exposure to contagions and other disease-causing stimuli.
Transportation of animals within the United States is subject to restrictions found at Title 49 of the US Code, section 80502 (West 2019). Known as the ‘28 Hour Law’, this federal statute prohibits the ‘confine[ment of] animals in a vehicle or vessel for more than 28 consecutive hours without unloading the animals for feeding, water, and rest’. The statute applies to:
- rail carriers, express carriers and common carriers (except by air or water);
- receivers, trustees or lessees of a carrier; and
- owners or masters of vessels or vehicles transporting the animals.
There are exceptions, as follows:
- the confinement period may be extended by an additional eight hours in two circumstances:
- when the transported animals are sheep and the 28-hour maximum concludes at night; and
- if the owner or custodian of the animals makes a separate request in writing for a time extension;
- any animal may be confined in excess of 28 hours if unloading the animal cannot be accomplished safely in light of ‘accidental or unavoidable causes that could not have been anticipated or avoided when being careful’; and
- the confinement period is inapplicable where the animals are transported by means that allow for food, water, space and an opportunity for rest.
Maximised confinement periods must be followed by five consecutive hours of release when food, water and rest are provided. Violations of the 28 Hour Law expose those bound by it to civil penalties ranging from US$100–US$500.
The Safe Air Travel for Animals Act governs the transportation of pets and other live animals through air travel.
The regulations are primarily codified under Title 9 of the Code of Federal Regulations. The USDA’s virtual ‘National Agricultural Library’ houses pertinent statutory and regulatory law and explanatory secondary sources in a retrievable format. The Humane Methods of Slaughter Act, FSIS regulations and training materials and Government Accountability Office enforcement reports are accessible through the USDA’s library.
In the United States, the Environmental Protection Agency (EPA) regulates pesticides, with authority derived from the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). FIFRA operates as a registration statute and requires EPA approval and registration of pesticides prior to their sale, distribution or use in the United States. A party seeking to register a pesticide must submit certain categories of testing data to the EPA. In determining whether to register a pesticide, the EPA engages in a cost-benefit analysis of the pesticide’s intended uses, weighing the potential adverse effects on human health and the environment against the benefits of the intended use. Additionally, states may regulate the sale and use of pesticides if they do not allow a sale or use that is prohibited by FIFRA. States cannot impose labelling requirements in addition to or different from those required under FIFRA.
The FDCA will apply if pesticides are applied to food or food crops. Under the FDCA, as amended by the Food Quality Protection Act, the EPA must establish a maximum safe level, or tolerance, of pesticide residue depending on the type of crop. Statutes such as the Endangered Species Act, the Clean Water Act and the Safe Drinking Water Act apply generally to a broader category of chemical use and storage, but certain pesticides may be addressed specifically.
Source: Faegre Drinker Biddle & Reath LLP - Breia L. Schleuss, Jacob D. Bylund, John P. Mandler and Sarah L. Brew
