This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.
New appropriations law gives added money to FDA’s food-safety functions. The FY 2023 Omnibus Appropriations Bill, signed into law December 29 by President Joe Biden, significantly increases funding for the FDA in fiscal 2023 as opposed to fiscal 2022. It provides $3.53 billion in discretionary funding for the FDA this year, which is $226 million more than the FY 2022 level. The increases for the FDA include $41 million for food safety activities, $121 million for cross-cutting initiatives supporting both medical and food safety, and $21 million for infrastructure investments.
FDA reminds farmers of key dates for its agricultural water requirements. On January 13, the FDA issued a formal reminder that January 26, 2023, will mark the end of a period of enforcement discretion for some water requirements enforced by the agency. These rules relate to the cleanliness and safety of water that is used in agriculture. The FDA noted that this January 26 date applies to all farming businesses except those that are classified as small or very small businesses; the agency’s enforcement discretion for these types of business will not end until January 2024 and January 2025, respectively. The FDA noted in its announcement that during the first year after the end of the intended enforcement discretion period, it will work closely with international, state and industry partners to advance training, technical assistance, educational visits, and on-farm readiness reviews to prepare both farmers and regulators for implementing these provisions.
Federal pilot project aims to curb the introduction of invasive aquatic species into Canadian freshwater. Last year, Canada’s federal government ran a pilot program to inspect and decontaminate boats at the international border between Manitoba and the US, in an attempt to prevent any accidental importing of zebra mussels and other invasive species into Canada. Native to Europe and Asia, zebra mussels are considered an aquatic invasive species in North America. They can harm native ecosystems by interrupting the food chain, damaging the survival of fish eggs, and increasing the likelihood of toxic algal blooms. In Manitoba, the introduction of zebra mussels could devastate the future viability of the province’s many commercial fisheries. Because zebra mussels can survive for long periods of time in wet and moist environments, all watercraft should be properly clean, drained, and dried before being transported over the border. It is a violation of Canada’s Aquatic Invasive Species Regulation to import a banned species into Canada, whether alive or dead. This is Canada’s first federal-level program to inspect watercraft for invasive species at an international land crossing.
Comments say that FDA would exclude many nutrient-rich foods from its proposed “healthy” definition. The first wave of comments about the FDA’s proposals regarding the permissibility of “healthy” claims on food labels includes observations that a variety of nutrient-rich foods would not meet new criteria because a low level of sugar has been added to them to improve palatability. On December 17, Food Navigator magazine noted that the United States Peanut Federation commented formally that many standard peanut butters, despite all the health benefits they provide, would be ineligible for the “healthy” claim because they contain a small amount of added sugar for palatability. The Cherry Marketing Association made a similar comment concerning dried tart cherries, which also may contain added sugars. The FDA issued its proposals in the wake of the White House Conference on Hunger, Nutrition and Health last September. Please also see our alert FDA proposes new rule for healthy labeling.
Consumer Reports circulates petition calling on FDA to ban Red Dye No. 3 from food. On January 17, Food Safety News reported that Consumer Reports is calling on its members to sign a petition to ban Red Dye No. 3 from use in food, medicines, and dietary supplements. More than 30 years ago, the FDA banned the use of the dye in cosmetics, but it has not yet banned it in food, medicines, and supplements, despite calls from Consumer Reports and others. The FDA has found that the dye causes cancer in animals and is a cause of hyperactivity in children. “If this dye isn’t safe for external cosmetic use, how is it safe for you or your family to eat?” Consumer Reports asked its readers. The petition has gathered support from the Center for Science in the Public Interest and other food safety organizations.
FDA continues to view titanium dioxide as an acceptable food additive. On December 12, the FDA told Food Navigator magazine that it has reviewed a scientific opinion from the European Food Safety Agency that formed the basis for the European Commission’s decision to ban the use of titanium dioxide in foods. The Center for Science in the Public Interest has also warned consumers to avoid the substance, based on existing research. However, the FDA’s review of the chemical, according to the magazine, resulted in a conclusion that available studies do not support any safety concerns about the use of the chemical as a color additive in foods. That conclusion formed and continues to form the basis for the FDA’s decision to continue to permit the use of titanium dioxide in foods, as long as that chemical does not exceed 1 percent of the weight of the food.
Some honey imported into the US found to be adulterated. The FDA said December 14 that 10 percent of imported honey samples that it recently assessed were found to be adulterated with undeclared added sweeteners that did not originate in honey. The agency said this demonstrates a need for continued testing to help prevent distribution of noncompliant products in the US market. The agency said this is a classic example of economically motivated adulteration or EMA because other sweeteners, such as cane syrup or corn syrup, are much less expensive than honey. EMA occurs, for example, when someone intentionally leaves out, removes, or substitutes a valuable ingredient or part of a food or when a substance is added to a food to make it appear better or of greater value. The FDA refused entry of all the violative shipments into the US.
FDA issues new guidance to state and local authorities in its 2022 Food Code. On December 28, the FDA issued the 2022 edition of its Food Code, which provides guidance to state and local authorities and retailers to help mitigate foodborne illness risks at retail establishments and to provide a uniform set of national standards for retail food safety. For the first time, the new code specifically addresses food donations. The code is part of the Biden Administration’s National Strategy on Hunger, Nutrition, and Health, rolled out in September at the White House Conference on Hunger, Nutrition, and Health. The Strategy provides a roadmap of actions the federal government is taking to end hunger and reduce diet-related diseases by 2030 – all while reducing food disparities. While adoption of the model Food Code is not required, it has been adopted by various states and local agencies regulating retail establishments such as restaurants, retail grocery stores, and other direct to consumer food service operations. This updated 2022 edition represents the FDA’s most updated advice for food safety in the retail setting.
Deadline looms for farms and agri-food operations to apply for COVID-19 workplace protection compensation from the Ontario government. Ontario’s Enhanced Agri-Food Workplace Program seeks to compensate farms and agri-food operations that have made changes to the workplace to prevent the spread of COVID-19. To be eligible, businesses must employ three or more paid workers and operate one of the approved businesses in Ontario. Funding is limited to $50,000 per business, property, or industry organization. The deadline to apply for this funding is January 31, 2023 at 5 pm.
New York City ban on foie gras may not take effect as planned. New York City’s ban on the sale of foie gras, the fattened livers of ducks and geese and a prized part of French cuisine, may not go into effect as planned, according to a ruling by New York State’s Department of Agriculture and Markets. On December 14, the department told City officials that the law “unreasonably restricts” the operations of the two farms that earlier in 2022 had sued about the ban. Passed by New York City in 2019 because of concerns about cruelty to animals, the ban would prohibit the farms and others from selling their foie gras in New York City, one of the country’s largest markets for the product. The ban was set to go into effect in November 2022, but in September, the New York State Supreme Court issued an injunction, ruling that farms could continue to sell foie gras to restaurants while the case made its way through the court system.
Bill in Tennessee legislature would require disclosure of the use of vaccines in food products. On January 6, a Tennessee state legislator introduced a bill that would require food manufacturers in that state to inform consumers if vaccines were used in the production of their food products. Representative Scott Cepicky, who is a cattle rancher, introduced the bill in the Tennessee General Assembly. In 2021, Cepicky had also introduced a bill that would have protected healthcare workers from mandatory vaccination. Vaccines are often used on animal herds to protect against diseases in the herd and can lessen the need for the use of animal antibiotics. The bill defines “vaccine” as “a substance used to stimulate the production of antibodies and provide immunity against disease, prepared from the causative agent of a disease, its products, or a synthetic substitute, treated to act as an antigen without inducing the disease, that is authorized or approved by the United States Food and Drug Administration.”
Ontario government launches cost-share funding supports to address avian flu. The Poultry Biosecurity Preparedness Initiative (PBPI), launched on January 12, 2023, is funded through the Canadian Agricultural Partnership and is offering up to $1.5 million to support agri-businesses affected by avian flu. PBPI is a cost-share funding support intended to help eligible non-supply managed poultry and waterfowl farmers, meat processors, and other businesses reduce the risk of spreading avian flu and increase biosecurity measures. The program will reimburse up to 70 percent of verified eligible expenses, to a maximum of $100,000 per expense, with a limit of $500,000 for a single business. Eligible expenses include education and training related to national biosecurity standards, operational improvements and implementation of preventative measures to reduce the likelihood of the introduction of avian flu, establishing cleaning and disinfecting practices, and establishing segregation facilities for high-risk poultry cohorts. Expenses incurred between April 1, 2022 and February 17, 2023 are eligible to be claimed, and claims must be submitted by February 28, 2023.
Canadian Food Inspection Agency (CFIA) launches online course for avian flu. The CFIA has partnered with the Animal Health Emergency Management Project and the United States Department of Agriculture to launch the Avian Influenza Emergency Preparation Course, which aims to teach diagnosis and investigative skills specific to avian flu to veterinarians, in an attempt to help curb the spread of avian flu in Canada. This federal course represents a growing effort by the Canadian government to limit avian flu, which is negatively affecting poultry and egg prices across the country. The bilingual course will be taught online from February 21 to March 31, 2023.
Meanwhile, in the US. Numerous American media outlets are noting that one consequence of the global spread of the highly contagious H5N1 strain of avian flu is the soaring price of eggs. The USDA reports that at this writing nearly 58 million domestic birds have been culled across the US in the outbreak. The worldwide toll among poultry is at least 140 million. In late December 2021, Urner Barry's Egg Price Current put the wholesale value of a dozen “Midwest large” eggs at 80 cents; in late December 2022, that price was $5.46. New Scientist magazine is reporting that many observers believe the only forward for agriculture may be mass vaccination of poultry for the H5N1 strain. The USDA’s Animal & Plant Health Inspection Service (APHIS) is reminding bird owners to review their biosecurity practices; it is working closely with health officials in the states on surveillance, reporting, and control efforts.
Study shows consumers are affected by climate labels on menus. A new research study shows that menu labels that warn of red meat’s negative impact on the climate may encourage consumers to opt for more environmentally sustainable options. In general, the study says, labels placed on fast food items highlighting their climate impact may sway consumers to make more sustainable choices. In the study, announced January 4 by the Johns Hopkins Bloomberg School of Public Health, more than 5,000 online participants were shown a sample menu resembling a fast-food menu and asked to choose a single item for dinner. One group of participants received a menu with non-red meat menu items such as chicken sandwiches labeled “low climate impact.” Another group received a menu with red meat items labeled “high climate impact.” A third control group received menus with QR codes on all items and no climate labels. According to the study, a significant number of members of both the first group and the second group acted to reduce their red meat selections.
One way in which the new mandatory sesame disclosure may be backfiring. On December 22, Food & Drink magazine reported that the new federal requirement to disclose the presence of sesame in food, effective January 1, has had the paradoxical effect of increasing the number of products that contain sesame. According to food industry experts, that’s because many manufacturers, especially bakers, find it easier and less expensive to add sesame to a product, and label it as such, than to try to keep it away from other foods or food-production equipment that have been in contact with sesame. This practice is perfectly legal but is causing consternation among groups that support people with allergies, and the FDA has said that it does not approve of the practice. To give one example, Olive Garden has announced that it is adding a minimal amount of sesame flour to its famous breadsticks “due to the potential for cross-contamination at the factory.”
When is Kona coffee not actually Kona? Coffee farmers from Hawaii’s famed Kona region have banded together to protect their brand. According to a December 28 article in Civil Beat magazine, the farmers want the state legislature to pass laws requiring higher percentages of actual Kona coffee in coffee that is allowed to carry the Kona name. The farmers say that both fast-food franchises and higher-end restaurants, as well as coffee roasters and packagers, are using as little as 10 percent authentic Kona coffee in certain blends, selling an inferior product and harming the Kona brand. The farmers are proposing that in 2023, legislators find ways to ensure that what is labeled Kona coffee is the real thing – including a possible requirement that any product labeled as Kona coffee be composed of at least 51 percent actual Kona coffee. The Hawaii Restaurant Association is fighting back, saying that Kona is so expensive that it needs to be blended with cheaper imports to make it a commercially viable product.