FDA has released a final rule on agricultural water that represents an important step toward enhancing the safety of produce. The revised requirements are intended to enhance public health by improving the safety of water used in produce cultivation. The revisions are also designed to be practical across various agricultural water systems, uses, and practices, while remaining adaptable to future advancements in agricultural water quality science.

The final rule replaces certain pre-harvest agricultural water requirements for covered produce (other than sprouts) in the 2015 produce safety rule with requirements for systems-based agricultural water assessments to determine and guide appropriate measures to minimize potential risks associated with pre-harvest agricultural water.

Specifically, this rule:

• Establishes requirements for agricultural water assessments that evaluate a variety of factors that are key determinants of contamination risks associated with pre-harvest agricultural water. This includes an evaluation of the water system, water use practices, crop characteristics, environmental conditions, potential impacts on water from adjacent and nearby land, and other relevant factors.
• Includes testing pre-harvest agricultural water as part of an assessment in certain circumstances.
• Requires farms to implement effective mitigation measures within specific timeframes based on findings from their assessments. Hazards related to certain activities associated with adjacent and nearby land uses are subject to expedited mitigation.
• Adds new options for mitigation measures, providing farms with additional flexibility in responding to findings from their pre-harvest agricultural water assessments.

Farms are required to conduct assessments of their pre-harvest agricultural water annually and, whenever a significant change occurs, to identify any conditions likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces.

These revised requirements reflect recent science, findings from investigations of several produce-related outbreaks, and feedback from a variety of stakeholders on the agricultural water requirements in the Produce Safety Rule, which were previously published in 2015. These revisions will more comprehensively address a known route of microbial contamination that can lead to preventable foodborne illness.

The rule also finalizes the dates for compliance with the pre-harvest agricultural water requirements for non-sprout covered produce as follows:

• For very small farms: 2 years, 9 months after the effective date of the final rule
• For small farms: 1 year, 9 months after the effective date of the final rule
• For all other farms: 9 months after the effective date of the final rule

The rule does not alter existing requirements for agricultural water for sprouts, for which compliance dates have passed. It also does not alter existing requirements for harvest and post-harvest agricultural water activities. Additional information about compliance dates can be found on the FDA Proposes Compliance Date Extension for Pre-Harvest Agricultural Water Requirements webpage.

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USDA’s Food Safety and Inspection Service (FSIS) has announced its final determination to declare Salmonella an adulterant in raw breaded stuffed chicken products when they exceed a specific threshold of 1 colony forming unit (CFU) per gram or higher for Salmonella contamination.

This determination is part of the agency’s efforts to reduce Salmonella illnesses associated with the raw poultry supply in the U.S. FSIS intends to address Salmonella contamination in other raw poultry products later this year.

“This final determination marks the first time that Salmonella is being declared an adulterant in a class of raw poultry products,” said Tom Vilsack, agriculture secretary, in an April 26 statement. “This policy change is important because it will allow us to stop the sale of these products when we find levels of Salmonella contamination that could make people sick.”

FSIS will carry out verification procedures, including sampling and testing of the raw incoming chicken component of these products prior to stuffing and breading, to ensure producing establishments control Salmonella in these products. If the chicken component in these products does not meet this standard, the product lot represented by the sampled component would not be permitted to be used to produce the final raw breaded stuffed chicken products. The determination, including FSIS’ sampling and verification testing, will be effective 12 months after its publication in the Federal Register.

In determining that Salmonella is an adulterant in raw breaded stuffed chicken products, FSIS considered the best available science and data using similar criteria as in its 1994, 1999, and 2011 E. coli policymaking. When FSIS declared seven Shiga toxin-producing E. coli (STEC) strains to be adulterants in select raw beef products, it relied on several factors, including the available information on serotypes linked to human illnesses, infectious dose, severity of illnesses and typical consumer preparation practices associated with a product. The breaded stuffed chicken products determination relied on the same factors.

FSIS and its public health partners have investigated 14 Salmonella outbreaks and approximately 200 illnesses associated with these products since 1998. The most recent outbreak was in 2021 and resulted in illnesses across 11 states. These products account for less than 0.15% of the total domestic chicken supply, but outbreaks linked to these products represented approximately 5% of all chicken-associated outbreaks in the U.S. from 1998 to 2020.

Raw breaded stuffed chicken products are pre-browned and may appear cooked, but the chicken is raw. The products are typically cooked by consumers from a frozen state, which increases the risk of the product not reaching the internal temperature needed to destroy Salmonella. Despite to improve labeling, these products continue to be associated with Salmonella illness outbreaks.

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To further protect the U.S. livestock industry from the threat posed by highly pathogenic H5N1 avian influenza, USDA has announced that it is taking specific actions with its federal partners to limit the disease’s spread.

USDA’s Animal and Plant Health Inspection Service (APHIS) announced a Federal Order requiring the following measures, effective Monday, April 29, 2024:

Mandatory Testing for Interstate Movement of Dairy Cattle

• Prior to interstate movement, dairy cattle are required to receive a negative test for Influenza A virus at an approved National Animal Health Laboratory Network laboratory.
• Owners of herds in which dairy cattle test positive for interstate movement will be required to provide epidemiological information, including animal movement tracing.
• Dairy cattle moving interstate must adhere to conditions specified by APHIS.
• As will be described in forthcoming guidance, these steps will be immediately required for lactating dairy cattle, while these requirements for other classes of dairy cattle will be based on scientific factors concerning the virus and its evolving risk profile.

Mandatory Reporting

• Laboratories and state veterinarians must report positive Influenza A nucleic acid detection diagnostic results (e.g. PCR or genetic sequencing) in livestock to USDA APHIS.
• Laboratories and state veterinarians must report positive Influenza A serology diagnostic results in livestock to USDA APHIS.

USDA has identified spread between cows within the same herd, spread from cows to poultry, spread between dairies associated with cattle movements, and cows without clinical signs that have tested positive. On April 16, APHIS identified a shift in an H5N1 sample from a cow in Kansas that could indicate that the virus has an adaptation to mammals.

CDC conducted further analysis of the specimen sequence, which did not change their overall risk assessment for the general public, because the substitution has been seen previously in other mammalian infections and does not impact viral transmission. Additionally, the APHIS National Veterinary Services Laboratories found H5N1 in a lung tissue sample from an asymptomatic cull dairy cow that originated from an affected herd and did not enter the food supply.

The novel movement of H5N1 between wild birds and dairy cows requires further testing and time to develop a critical understanding to support any future courses of action, USDA said in a statement, adding that requiring positive test reporting will help the agency better under the disease and testing before interstate movement will limit its spread.

The agency has not found changes to the virus that would make it more transmissible to humans and between people and CDC believe that the current risk to the public remains low.

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Robert Califf, FDA’a commissioner, reiterated the agency’s year-old appeal to Congress for a framework enabling the sale of cannabidiol (CBD) as a dietary supplement and as a food ingredient. Currently, FDA believes it lacks the authority to pursue this course of action within its existing structure.

Califf addressed a U.S. House of Representatives oversight committee earlier this month and noted that FDA deemed hemp-derived CBD not sufficiently safe for lawful sale as a dietary supplement. He urged Congress to establish a pathway for regulating the substance.

Based on a recent report from the World Health Organization (WHO), CBD shows promising therapeutic potential in various trials, both controlled and open label, demonstrating good tolerance and a favorable safety profile.

The regulation of hemp derivatives, including CBD, has been a matter of concern since the legalization of its cultivation in the 2018 Farm Bill, predominantly crafted by USDA and ratified by Congress. Since then, the product has become widespread as a supplement and has also found its way into certain food and beverage items, despite FDA never officially declaring it safe as a food ingredient. “It’s Congress’s decision to make, so we would really look forward to work with you all as quickly as possible to come up with a regulatory pathway that you think is reasonable and enables us to take action,” Califf said during his address.

James Comer, chairman of the House Committee on Oversight and Accountability, sent a letter to Califf on Wednesday in reply, stating it is imperative that FDA engages in this regulation quickly, safely, and efficiently to provide proper guidance to consumers about the safety of CBD products. “Without allowing for therapeutic CBD products to be regulated as dietary supplements such as melatonin or fish oils, the good faith actors in the industry are unable to enter the market and provide people with helpful products because they are currently not distinguished under the FDA from the intoxicating products containing Delta-8,” he wrote, asking FDA for documents and information to enable oversight of the agency’s actions.

Another issue gaining steam revolves around the national legalization of tetrahydrocannabinol (THC), the intoxicating component of marijuana, and its potential integration into food and beverage items. While some states where the drug is already legalized have incorporated it into food products, interstate transportation of such products remains prohibited.

Califf has gone on record declaring there is no justification for the Drug Enforcement Administration (DEA) to prolong its decision regarding the rescheduling of marijuana from a Schedule I to a Schedule III substance, thereby aligning it with medications such as acetaminophen and ketamine, rather than with substances like heroin and LSD.

“This is an area where I believe we would be better off if we had guidance from Congress about how to proceed,” Califf said.

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A Texas dairy worker has tested positive for the highly pathogenic avian influenza (HPAI) H5N1, according to the CDC. The person inflicted has a mild case and is believed to be just the second human ever to have contracted the virus.

The news comes on the heels of USDA confirming detection of HPAI in seven dairy herds in Texas, two in Kansas, and one a piece in Idaho, Michigan, and New Mexico. The National Veterinary Services Laboratories is performing additional tests on presumptive positive results from Kansas, New Mexico, Ohio, and Texas.

“This infection does not change the H5N1 bird flu human health risk assessment for the U.S. general public, which CDC considers to be low,” USDA said in a statement.

Richard Webby, PhD, director of the World Health Organization Collaborating Centre for Studies on the Ecology of Influenza in Animals and Birds, and a virologist at St. Jude Children’s Research Hospital, tells Food Quality & Safety that dairy herd infections are extremely rare. “There were some hints of data that suggested cows could be sporadically infected with influenza A viruses, but many, including me, never thought of cows as likely hosts of the virus,” he says. “No one knows how the cows got infected and how it is moving between them now. There were reports of sick birds on the initial farms, but how the virus got from there to cows is unclear. If we can understand how the virus is moving, we can likely do many things to reduce the risk.”

He notes that this virus remains very much a bird virus, even after replicating in cows. As such, the risk to humans is low. “It is of course higher in those with close contact with the sick animals,” Dr. Webby adds. “Risk to the general population is very low, rock to workers is low, but certainly not zero, as highlighted by the one conjunctivitis case.”

A joint statement released by the National Milk Producers Federation, the International Dairy Foods Association, the U.S. Dairy Export Council, and Dairy Management Inc., noted that routine testing and well-established protocols for U.S. dairy will continue to ensure that only safe milk enters the food supply. “In keeping with the federal Grade A Pasteurized Milk Ordinance (PMO), milk from sick cows must be collected separately and is not allowed to enter the food supply chain,” the statement reads. “This means affected dairy cows are segregated, as is normal practice with any animal health concern, and their milk does not enter the food supply.”

Since 2022, HPAI has been detected in wild, commercial, and hobbyist bird flocks in more than 82 million birds across 48 states and 512 counties, according to the CDC.

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A California assembly member has introduced legislation that would prohibit the state’s public schools from serving foods that contain certain additives. In particular, Assembly Bill (AB) 2316, introduced by Jesse Gabriel (D-Encino), would prohibit schools from serving foods containing six synthetic food dyes—Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, and Green 3.

Currently, products containing these dyes are required by the EU to carry a warning label.

The introduction of AB 2316 follows the 2023 passage California Food Safety Act – which banned the use of four chemicals from foods sold in California. Like the California Food Safety Act, AB 2316 would not ban any specific foods or products; rather, Gabriel says it would encourage companies to make modifications to products sold in the state.

AB 2316 now heads to the Assembly Education Committee, where it is expected to be heard in the coming weeks.

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USDA has finalized a rule to align the voluntary “Product of USA” label claim with consumer understanding of what the statement means. Tom Vilsack USDA agriculture secretary, also says the agency is awarding $9.5 million to 42 projects through the Local Meat Capacity grant program to expand processing options for the meat and poultry industry and new actions to ensure transparency and a fair and competitive market in the U.S seed industry.

These actions build on President Biden’s Executive Order on Promoting Competition in the American Economy and the Biden-Harris Administration’s Action Plan for a Fairer, More Competitive, and More Resilient Meat and Poultry Supply Chain, the agency says, adding that they are intended to help increase competition in agricultural markets, create a fairer playing field for small- and mid-size farmers, lower grocery costs for consumers, and strengthen local and regional food systems.

The final rule allows the voluntary “Product of USA” or “Made in the USA” label claim to be used on meat, poultry and egg products only when they are derived from animals born, raised, slaughtered and processed in the United States. The rule will prohibit misleading U.S. origin labeling in the market and help ensure that the information that consumers receive about where their food comes from is truthful.

Under the rule, the label claim will continue to be voluntary. It will also remain eligible for generic label approval, meaning it would not need to be pre-approved by USDA’s Food Safety and Inspection Service (FSIS) before it can be used on regulated product but would require the establishment to maintain documentation on file to support the claim. The final rule also allows the use of other voluntary U.S. origin claims on meat, poultry and egg products sold in the marketplace. These claims will need to include a description on the package of the preparation and processing steps that occurred in the United States upon which the claim is made.

USDA has also published an updated labeling guidance on the use of voluntary U.S.-origin label claims to provide examples of claims and the types of documentation that establishments may maintain to support use of the claims. The guidance will be open for public comment for 60 days after publishing in the Federal Register. Public comments can be submitted at www.regulations.gov.

Establishments voluntarily using a claim subject to the final rule will need to comply with the new regulatory requirements by January 1, 2026.

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On March 6, FDA sent a letter to all cinnamon manufacturers, processors, distributors, and facility operators in the U.S. reminding them of the requirement to implement controls to prevent contamination from potential chemical hazards in food, including ground cinnamon products. The agency is also recommending the voluntary recall of certain ground cinnamon products sold by a number of brands at six different retail chains that were found to contain elevated levels of lead.

The agency also notified the distributors and manufacturers of six specific products found to contain elevated levels of lead and recommended that the manufacturers voluntarily recall these products because prolonged exposure to them may be unsafe. The products were identified during an FDA-initiated sampling and testing effort to assess cinnamon sold across numerous retail stores, and include La Fiesta Food Products, Marcum Moran Foods, MTCI, SWAD Raja Foods, Supreme Tradition Grenbriar International, and El Chilar.

No illnesses or adverse events have been reported to date related to these specific ground cinnamon products, but the agency is concerned that, due to the elevated lead levels in these products, continued and prolonged use of the products may be unsafe.

FDA is advising consumers to throw away and to not purchase the identified ground cinnamon products and it firms to voluntarily recall the products, with the exception of the MTCI cinnamon, which the agency has been unable to reach as of March 6.

Additionally, the agency says the lead levels found in the ground cinnamon products included in this latest alert are significantly lower than the levels in cinnamon in the recalled applesauce pouches removed from the market this past fall.

See the FDA website for the full list of lot codes impacted by this latest effort.

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FDA has announced that grease-proofing materials containing per- and polyfluoroalkyl substances (PFAS) are no longer being sold for use in food packaging in the U.S. This means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags has been eliminated.

PFAS, also known as “forever chemicals” are a diverse group of thousands of chemicals that resist grease, oil, water, and heat. FDA has authorized certain of these substances for limited use in cookware, food packaging, and food processing equipment. Exposure to some types of PFAS have been linked to serious health effects.

The announcement marks the fulfillment of a voluntary commitment by manufacturers to not sell food contact substances containing certain PFAS intended for use as grease-proofing agents in the U.S. “This FDA-led effort represents a positive step forward as we continue to reevaluate chemicals authorized for use with, and in, food,” said Jim Jones, deputy commissioner for human foods, in a statement. In 2020, the FDA engaged companies to cease sales of grease-proofing substances that contain certain types of PFAS following a post-market safety assessment conducted by the agency.

FDA says it will continue to conduct research and update its evaluations using the most up-to-date science to ensure that its risk determinations continue to be accurate and based on current science.

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FDA has confirmed that lead and chromium detected in the cinnamon in applesauce pouches imported from Ecuador are from lead chromate. Three brands of applesauce pouches, manufactured in Ecuador and sold under WanaBana, Weis, and Schnucks brands, were recalled last November due to lead contamination.

Historically, lead chromate has been illegally added to certain spices increase to their weight and enhance their color, which increases the monetary value of the adulterated spices, the agency said in a February 29 statement. FDA’s leading hypothesis remains that this was likely an act of economically motivated adulteration.

FDA has limited authority over foreign ingredient suppliers who do not directly ship product to the U.S. This is because their food undergoes further manufacturing/processing prior to export. Therefore, FDA has limited ability to take direct action with Negasmart, the supplier of cinnamon to Austrofoods, or Carlos Aguilera, the processor of the cinnamon sticks.

Ecuadorian officials in Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) have reported that Carlos Aguilera of Ecuador, is the likely source of contamination and is not in operation at this time.

The CDC has identified 468 total cases of contamination in 44 states. The investigation is ongoing.  

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