This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape.
Plan to reorganize USDA announced. Calling the USDA a “bloated, expensive and unsustainable organization,” Secretary of Agriculture Brooke Rollins has announced a sweeping plan to reorganize the department. Rollins set out the four pillars of the reorganization plan: aligning the size of the department’s workforce with agricultural priorities and financial resources; bringing USDA closer to its customers; eliminating bureaucracy; and consolidating redundant support functions. A key part of the reorganization: scaling down and shuttering offices in the National Capital Region (NCR) and relocating the agency ‘s headquarters and much of the staff currently based in the NCR to five hubs across the country: Raleigh; Kansas City; Indianapolis; Fort Collins; and Salt Lake City. Of the 4,600 USDA employees based in the NCR, about 2,000 would reportedly remain. Interestingly, comments on the reorganization are not to be submitted through the Federal Register but by emailing reorganization@usda.gov.
Trey Forsyth is named USDA’s acting Deputy Under Secretary for Food Safety. Trey Forsyth has been named the USDA’s acting Deputy Under Secretary for Food Safety. He will head the USDA’s Office of Food Safety, which oversees the Food Safety and Inspection Service, while the department awaits the Senate’s decision on the confirmation of Mindy Brashears as Under Secretary for Food Safety – she is one of 253 appointees currently awaiting Senate confirmation. Forsyth has served in government affairs roles in private industry and as a policy advisor to Gregg Doud, the Chief Agriculture Negotiator at the Office of the US Trade Representative. Most recently, he served on the professional staff of the Senate Committee on Agriculture.
Sean Keveney is named FDA Chief Counsel. On August 4, FDA named Sean Keveney as its new chief counsel, replacing Robert Foster, who this week was confirmed as General Counsel at HHS. Most recently, Keveney served as Acting General Counsel at HHS, where he led legal efforts to implement key administration priorities and regulatory reforms under the Make America Healthy Again agenda. Before joining HHS, Keveney worked for 16 years at the Department of Justice’s Civil Rights Division.
CFIA begins campaign targeting SFC-licensed manufactured food operators in inspections. The Canadian Food Inspection Agency (CFIA) published a Notice to Industry in July that advised it has begun inspecting Safe Food for Canadians (SFC) license holders engaged in the manufacture of foods, to assess compliance with the Safe Food for Canadians Regulations (SFCR). The inspections focus on whether license holders have implemented and are actively using Preventive Control Plans (PCPs) as required under Part 4 of the SFCR, and whether their license accurately reflects current operations and commodities. Businesses found non-compliant may face enforcement actions, including license suspension or cancellation. The move, announced in early July, is part of CFIA’s ongoing effort to uphold food safety and public confidence in Canada’s food system.
FDA releases new food toxicity screening tool. On July 30, the FDA released its Expanded Decision Tree (EDT) chemical toxicity and risk screening tool, designed to evaluate chemicals based on their structural features to determine the safety of their use in foods. The EDT is based on the Cramer Decision Tree tool, widely used by scientists, FDA states, “to sort chemicals into classes of chronic toxic potential using a series of mainly chemical structure-based questions… to provide a quick, preliminary estimate of a new chemical’s predicted toxicity, especially when the testing data about a chemical is limited.” The EDT expands and refines the original tool’s capabilities to allow classification of chemicals with greater specificity. After an external peer review, the updated EDT is now being shared with the scientific community. It will eventually be used in both pre- and post-market chemical evaluation to help ensure the food supply remains safe. The agency is also developing what it describes as a software version of the EDT for general public use.
Food Traceability Rule compliance date extended to 2028. FDA published a proposed rule to extend the compliance date for the Food Traceability Rule by 30 months, to July 20, 2028. The extension was anticipated in response to industry requests for additional time beyond the original January 2026 deadline to meet the rule’s enhanced traceability requirements.
Reagan-Udall Foundation’s Roadmap to Produce Safety calls for formation of stakeholder-led coalition. The Reagan-Udall Foundation for the FDA (RUF) has issued its FDA-commissioned report, Roadmap to Produce Safety: Summary Report of the Produce Safety Dialogue. Summing up RUF’s “produce safety dialogue” with more than 170 stakeholders in the produce sector, the report presents recommendations on how to form and manage a private-sector-led collaboration and the strategic priorities that such a collaboration might pursue. The report identifies the overall need to form a collaborative organization to provide leadership and infrastructure to help participants “develop and maintain trust to achieve the objectives laid out in the report. After determining the collaboration model, the report encourages “a small multi-stakeholder leadership group” to take specific steps, including:
- Following up with Produce Safety Dialogue participants to assess willingness to engage in an ongoing effort and identify committed leaders from each sector
- Convening interested parties from each sector to set and secure an initial investment commitment (financial or other) and timing for that commitment, as well as align on a request for proposals for the potential convener, facilitator, or project manager
- Issuing a request for proposals, reviewing responses, and choosing a convenor, facilitator, and/or project manager
The report encourages the convening entity to highlight priority activities identified by the Produce Safety Dialogue for a finite (eg, five-year) timeframe. For more information, see the full report. In a press release, FDA stated that it “will actively participate in this effort and agrees with the report’s recommendation that regulators should not own or lead the coalition.” That press release also noted other FDA efforts to carry forward “ongoing prevention activities that complement the recommendations from the report.” In conjunction with those activities, FDA announced a national search for a director of the new Office of Produce Safety.
AHS links Saskatoon Farm foodborne illness outbreak in Canada to contaminated water. On July 25, Alberta Health Services (AHS) declared a presumptive outbreak of enteroinvasive E. coli and amoebiasis at Saskatoon Farm near Okotoks, Alberta. As of July 28, AHS reported 26 probable E. coli cases, nine Entamoeba histolytica detections, and over 235 people reporting symptoms. Norovirus and rotavirus have also been identified. AHS suspects the outbreak stemmed from groundwater contamination of the facility’s cistern-fed water supply, likely following heavy rains. All food services at the farm have been ordered closed since July 23 and will remain so until AHS deems it safe to reopen. The incident underscores the critical importance of water quality control in rural food service operations.
FDA moves to reclassify a synthetic opioid derived from kratom as a controlled substance. On July 29, the FDA said it is moving to reclassify 7-hydroxymitragynine (7-OH), a potent synthetic opioid derived from kratom, as a controlled substance by the Drug Enforcement Agency. It is also launching a public education campaign about the dangers of 7-OH. The move comes as products containing 7-OH are appearing for sale in vape shops, gas stations, and other outlets across the country. In mid-July, the agency sent warning letters to seven companies that market products containing 7-OH and stated that 7-OH is “not a lawful dietary supplement, food additive, or ingredient in any approved drug” and is therefore being illegally marketed. The FDA campaign about 7-OH will include a “Dear Colleague” letter for healthcare professionals and a report for consumers. As we’ve reported in the past, kratom, Mitragyna speciosa, is banned in several Asia Pacific countries and several US states but is openly marketed online; it has become a popular folk treatment for pain and symptoms of opioid withdrawal, and the FDA has occasionally moved to seize products containing it, stating that dietary supplements containing kratom are to be considered adulterated under the Federal Food, Drug, and Cosmetic Act.
FDA announces 2026 user fees for VQIP and TPP. On July 29, the FDA announced FY 2026 user fee rates for the Voluntary Qualified Importer Program (VQIP) and Accredited Third-Party Certification Program (TPP). The VQIP, FDA says, “offers expedited review and importation of human and animal foods into the US for importers who maintain a high level of control over the safety and security of their supply chains.”; under the TPP, third-party certification bodies accredited by FDA-recognized accreditation bodies “conduct food safety audits and issue certifications of foreign food facilities.” The programs, authorized under the Food Safety Modernization Act, help ensure that foods imported into the US have been produced under the same safety standards required for US-made foods and, FDA says, to “address potential safety issues before the food reaches the United States.”
FDA proposes amending Standard of Identity for pasteurized orange juice. As part of its ongoing review of more than 250 Standards of Identity (SOI), on August 5, the FDA released a proposed rule that would amend the 62-year-old SOI for pasteurized orange juice. Under the proposed rule, the minimum Brix requirement – a measure of a liquid’s sugar content – would be reduced to 10 percent, from the current 10.5 percent. The agency states that the proposed change is being made in response to a 2022 citizen petition submitted by the Florida Citrus Processors Association and Florida Citrus Mutual.
Canada-Australia beef trade reopens after 20-year ban. On July 29, the Canadian Food Inspection Agency (CFIA) announced that Canada has regained access to the Australian market for Canadian beef and beef products, reopening a trade corridor that had been closed since 2003 due to BSE (bovine spongiform encephalopathy)-related restrictions. With Canada now internationally recognized as a negligible BSE risk, the reopening reflects growing trust in Canadian food safety standards and bolsters Canada's Indo-Pacific Strategy. Industry experts expect the move to unlock new economic potential for Canadian producers, support domestic jobs, and enhance Canada's agri-food footprint in this key economy.
Brazilian coffee companies redirect coffee sales to China in response to US tariffs. In a social media post uploaded on August 3, the Chinese embassy in Brazil announced that China has approved export permits for 183 Brazilian coffee companies to sell their products on the Chinese market, effective July 30. The 50 percent tariffs imposed by the US on certain Brazilian products, including coffee, became effective August 6. Brazil supplies about a third of all the coffee the US drinks - reportedly, in June this year it exported 440,034 60-kilo bags of coffee into the US – nearly 8 times as much as it exported to China. The website Coffee Intelligence comments that a 50 percent US tariff on Brazilian beans “represents a serious economic threat” to Brazil, impacting the more than 8 million people in the rural economy who work in coffee production, and that the tariffs also could lead to a reshaping of marketing patterns, with “ American buyers turning to other origins, while Brazil redirects shipments toward Europe and Asia.”
US tariffs may hurt US chocolate producers. On July 30, Reuters reported that tariffs levied on cocoa products are paradoxically making the price in the US of domestically made chocolates higher than the price for chocolates imported from Canada and Mexico. Under the United States-Mexico-Canada trade pact – which is still in effect – Mexico and Canada may export chocolate to the US tariff free regardless of the cocoa’s source. Mexico grows its own supply of cocoa, and Canada has no tariffs on cocoa imports. Contract chocolate makers in Mexico and Canada, and international contract chocolate makers with operations in those countries – who produce raw chocolate that is then shipped to US manufacturers, who process it and sell it as American chocolate – are benefiting the most, Reuters reported. It went on to note that some major chocolate companies are considering moving their candy making operations offshore.
Misleading “Made in Canada” branding prompts scrutiny of grocer compliance. A CBC investigation published July 24 uncovered widespread mislabeling and misleading “Product of Canada” or “Prepared in Canada” signage at major Canadian grocers. Certain grocery stores were found to be advertising packaged goods and, in particular, produce as a product of Canada, despite statements on the products’ own packaging stating their foreign origin. The Canadian Food Inspection Agency (CFIA) confirmed it has received 97 complaints regarding country-of-origin claims since November 2024, with 32 percent of investigated cases resulting in regulatory violations. Under CFIA rules, “Product of Canada” and “Made in Canada” designations carry specific requirements, including meaningful Canadian transformation or origin. Experts and consumers are calling on retailers to align their promotional campaigns with accurate labeling. Grocers have promised improvements, but concerns about consumer trust persist.
Federal lawsuit targets Oregon’s Plastic Pollution and Recycling Modernization Act. Oregon’s Plastic Pollution and Recycling Modernization Act (RMA), one of the first extended producer responsibility (EPR) laws implemented in the US, is facing its first challenge in court. The outcome of the suit could have significant implications for both the RMA and similar EPR laws taking effect in other states. See our alert.
CDC: Americans get more than half of their calories from ultra-processed foods. A new data brief from the Centers for Disease Control and Prevention reports that most Americans get more than half their calories from ultra-processed foods. In a study drawing on data from the August 2021–August 2023 National Health and Nutrition Examination Survey, CDC researchers found that in that period, children 18 and younger “consumed 61.9% of their daily calories, on average, from ultra-processed foods, while adults consumed 53.0% of their daily calories from ultra-processed foods.” Among the young, family income levels did not appear to affect these eating patterns, while among adults, consumption of ultra-processed foods was "lower in those with the highest family income.” Interestingly, the study found “no significant differences were noted between males and females for either youth or adults.” Researchers characterized the types of food processing using the Nova classification system, which categorizes foods from unprocessed to ultra-processed, and used the 49 food categories in the USDA’s What We Eat in America database to describe the top caloric contributors of ultra-processed foods. Read the study here.
IFIC report: consumer confidence in safety of the food supply is at a 13-year low. The 2025 Food & Health Survey from the International Food Information Council (IFIC) concludes that consumer confidence in the safety of the US food supply is at a 13-year low. The annual survey asks American consumers about their perceptions, beliefs, and behaviors around food and food-purchasing decisions. This year, the report found only 55 percent of respondents told IFIC that they are “very confident” or “somewhat confident” in the safety of the food supply – a dramatic decline from 2023 (70 percent) and 2024 (62 percent), and the lowest percentage found since IFIC began assessing such consumer confidence in 2012. The decline, the report found, was notable across all age demographics. The survey also found a rise in consumer confidence in imported foods – where in 2014, 52 percent of respondents said they believed US foods were safer than imported foods; by this year, that percentage had fallen to only 32 percent. Respondents cited their concerns about food-borne pathogens, pesticide residues, and toxic heavy metals in food, and, reflecting the rising attention being given to the safety of food additives, eg, food dyes and other chemicals. Forty percent of respondents stated that they would be more confident in the food supply if stricter food safety regulations were in place, and 40 percent also said they would feel more confident in US food safety if they had a better understanding of the ways companies and the government ensure food safety. IFIC surveyed 3,000 Americans in March this year, weighting results, it stated, “to ensure that they are reflective of the American population ages 18 to 80, as seen in the 2024 Current Population Survey.” This is the 20th annual IFIC Food & Health Survey. Download it here.
Avian flu update.
- Among dairy producing states in the US, California has been hit the hardest by H5N1: since August 2024 more than 75 percent of its 1,000 dairy farms have experienced outbreaks of the virus and the attendant steep decline in milk production. In November 2024, the USDA opened the Emergency Assistance for Livestock, Honeybees, and Farm-Raised Fish Program (ELAP) – intended to mitigate the impact of drought, flooding, and wildfire on farmers – to dairy producers. The Los Angeles Times reported on July 28 that California dairy producers have received more than $230 million in emergency relief under ELAP since then. Reportedly, most of the payments provided in May and June this year arose from 2024 outbreak events, suggesting it is likely that payouts will continue for some time as claims are processed. The Los Angeles Times went on to quote Anja Raudabaugh, CEO of the trade group Western United Dairies, stating that the payouts have “ensured our dairy communities and their workers stay employed and healthy. Until we get approval of a dairy cow vaccine, weathering this storm has only been possible with the assistance of the milk loss payments.”
- On August 5, the Department of Health and Human Services eliminated 22 mRNA vaccine development projects for avian influenza and COVID-19 being carried out at the Biomedical Advanced Research and Development Authority (BARDA). Going forward, HHS Secretary Robert F. Kennedy, Jr. said, vaccine research at BARDA will focus on whole-virus vaccines and novel platforms. In addition to terminating contracts and grants for research at an array of laboratories and universities across the country, Kennedy’s decision cancels numerous pre-award solicitations from leading pharmaceutical companies that had been part of BARDA’s Vaccine Innovations and Therapeutics Acceleration Launchpad Hub and Rapid Response Partnership Vehicle. At this writing, mRNA research being conducted at the Advanced Research Projects Agency for Health and the NIH is not affected.
- A new study published on July 31 on preprint server bioRxiv finds that H5N1 may be transmitted not just via direct contact with contaminated surfaces (such as milking equipment) but through the air and water. In the study, scientists sampled air, farm wastewater, and milk on 14 H5N1-positive dairy farms across two different California regions. They found H5N1 virus in the air of milking parlors – “suggesting that airborne transmission may serve as a mode of H5N1 spread between cows and to humans” – and in the wastewater used to clean milking equipment. The researchers also found high viral loads in the milk of some cows that showed no clinical signs of illness. They conclude, “Multiple mitigation strategies should therefore be implemented to reduce the risk of H5N1 spread within a herd and to humans,” including providing workers with respiratory and ocular personal protective equipment. The study, “Surveillance on California dairy farms reveals multiple sources of H5N1,” has not yet been peer reviewed.
- Clusters of H5N1 have lately been reported in poultry facilities and home flocks in Cambodia (where this year 15 human infections have been confirmed), Germany, India, Israel, South Africa, and the UK. In the latter, multiple outbreaks have been confirmed in poultry farms and backyard flocks across the country, leading to the creation of avian influenza prevention zones setting out an array of biosecurity measures. Events involving gatherings of birds, such as markets, fairs, and exhibitions have been banned in the UK since February.
- Also in the UK, an avian influenza vaccination task force stated in late July that for now poultry flocks in the UK should not be vaccinated for H5N1 and that strict biosecurity measures remain the preferred way to prevent infection. But, because “significant uncertainties remain” around vaccination, the joint industry and cross-government group is also recommending targeted on-farm vaccination trials in turkeys. "Economic modelling suggests that turkeys offer a favourable value for money profile due to their higher per-bird value and shorter production cycles,” the task force stated. “A targeted trial in this sector would generate UK-specific evidence on vaccine efficacy, duration of immunity, and surveillance feasibility.”
- On July 28, the World Health Organization, the UN’s Food and Agriculture Organization, and the World Organisation for Animal Health issued a joint public health assessment that the global public health risk of avian flu is low at the moment; the health risk for “occupationally or frequently exposed” people, such as farmworkers and owners of backyard flocks, is “low to moderate depending on the risk mitigation and hygiene measures in place.” The assessment primarily focuses on 2025 data to summarize the global impact of H5 infections in humans and in domestic and wild animals, then goes on to urge governments to increase surveillance and reporting of avian flu in human populations, “especially amongst occupationally exposed persons” and in domestic birds, wild birds, and mammals; to strengthen biosecurity measures; and to report and share “information and sequence data from both the human and animal health sectors” in a timely way. See the assessment here.
- The Johns Hopkins School of Public Health’s weekly podcast, Public Health on Call, recently asked “Is Bird Flu Gone for Good?” Dr. Erin Sorrell, a Senior Scholar at the Johns Hopkins Center for Health Security and an Associate Professor at Johns Hopkins Bloomberg School of Public Health, stated that outbreaks on poultry and dairy farm in the US are low at the moment, but that they will likely begin to rise as migratory birds begin moving again in the fall. Planning for that, she continued, will be complicated by a number of factors, among them the CDC’s recent decisions to change its reporting on H5N1 outbreaks from weekly to monthly and to no longer report USDA data on agricultural outbreaks. That change, she said, effectively ends integrated coverage of the virus’s impact “so it will be much harder to track when a surge happens or when there’s an uptick in potential exposures.” The USDA data still appears on the USDA’s sites. Federal officials have not held any briefings about the H5N1 outbreak since President Donald Trump took office.
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