• Iowa and 22 states have filed a brief supporting the petition of the Iowa Pork Producers Association (IPPA) to the Supreme Court for a writ of certiorari to review the judgment of the 9th Circuit Court of Appeals in a case involving a challenge to California Proposition 12. Prop 12 is an animal welfare law which prohibits the sale of pork from swine housed in conditions inconsistent with California standards.
  • In National Pork Producers Council (NPPC) v. Ross, the Supreme Court, in a fractured opinion, dismissed a similar challenge to Prop 12 and held that it did not violate the dormant commerce clause.
  • However, IPPA argues that this case presents different questions, in part because it alleges discrimination against out-of-state pork producers. In contrast, NPCC had disavowed any discrimination-based claims in their challenge to Prop 12.
  • The petition for certiorari also requests that the Court address the issue of whether dissenting opinions should be considered in determining a majority opinion on a point of law. In affirming the dismissal of the IPPA challenge to Prop 12, the 9th Circuit applied its own precedent and not the Supreme Court’s precedent in NPPC v. Ross because the “majority of the Justices . . . did not agree upon a single rationale and there is no opinion that can reasonably be described as a logical subset of the other.”
  • A grant of writ of certiorari is up to the discretion of the Supreme Court, but the Court typically considers factors that include the importance of resolving conflicts in judicial interpretations and the significance of the issue(s).
  • The Trump administration has named Gerald Parker to lead the White House Office of Pandemic Preparedness and Response Policy. Parker is a veterinarian and has served in the Departments of Health & Human Services, Homeland Security, and Defense.
  • Most recently, Parker served as the associate dean for Global One Health at Texas A&M’s College of Veterinary Medicine and Biomedical Sciences. In this role, he advised lawmakers on the U.S. bird flu outbreak that has sickened at least 66 people.
  • Congress established the White House Office of Preparedness and Response Policy in 2022 as the Covid-19 pandemic began to abate. The office advises the President on pandemic preparedness and response policy, drives interagency strategic coordination and communication in preparation for and response to biological threats, and promotes and supports the development of relevant expertise and capabilities to ensure the U.S. can quickly detect, identify, and respond to such threats.
  • On February 4, 2025, Utah’s state legislature introduced H.B. 402, “Foods Available at Schools Amendments,” a bill aimed at amending the types of foods available in public schools. This bill specifically targets the prohibition of certain food additives, utilizing a unique definition of “ultra-processed foods” (UPFs), a category of foods yet to be formally defined by law or regulation.
  • The bill attempts to define UPFs as foods or beverages containing one or more of the following ingredients: brominated vegetable oil, potassium bromate, propylparaben, titanium dioxide, and various artificial dyes such as blue dye 1, blue dye 2, green dye 3, red dye 3, red dye 40, yellow dye 5, and yellow dye 6.  We note that both bromated vegetable oil and red dye 3 have had their market authorizations revoked by FDA.  
  • —The definition of UPFs as presented is entirely focused on artificial dyes and a few specific additives that does not encompass the broader range of ingredients and processes that typically characterize UPFs under the academic classifications that are in circulation.
  • The bill’s definition seems to reduce UPFs to a list of artificial dyes and a few other additives, demonstrating the confusion surrounding this issue, and the potential for policymaking not grounded in science.  
  • Keller and Heckman will continue to monitor developments related to the definition of “UPF” and regulations targeting this category of products. 
  • The Non-GMO Project has introduced a logo that would highlight foods that do not contain “ultra-processed” ingredients, called “Non-UPF Verified.”  The program was created by the Non-GMO Project’s newly established Food Integrity Collective.  The founder and CEO of the Non-GMO Project and the Food Integrity Collective, Megan Westgate, alleged that “[t]he Standard American Diet has become one of the leading risk factors for death worldwide, yet navigating today’s food landscape can feel like an impossible task.”
  • The new certification will complement the Butterfly seal, intended to help consumers choose foods that the Non-GMO Project believes promote food that is not ultra-processed.  According to the organization, “Non-UPF Verified” will set clear standards and encourage food manufacturers to offer more minimally processed options, based on an “8-Petal Framework for Food Integrity.”
  • The term “ultra-processed food” is not formally defined, which raises questions as to how the certification program defines the term and whether the logo will be meaningful.  For example, the National Institute of Health (NIH) defined “ultra-processed foods” in 2019 as foods that modify the nutritional content of their ingredients to boost their profitability, convenience, and shelf life. However, other definitions vary and there is no consensus.
  • The new certification program will launch its pilot phase in Spring 2025 and food manufacturers interested in the certification can learn more at: www.nonultraprocessed.org.
  • Last month, Representatives Steven Womack (Arkansas) and Tracey Mann (Kansas) introduced a bill which, if passed, would prevent USDA from finalizing, implementing, administering, or enforcing the proposed rule “Salmonella Framework for Raw Poultry Products.” 89 Fed. Reg. 64678 (Aug. 7, 2024).
  • Under the proposed rule, raw poultry containing 10 or more colony forming units (CFU) of any Salmonella and any detectable level of Salmonella serotypes of public health significance would be considered adulterated under the Poultry Products Inspection Act. If the standard is finalized, it would also be accompanied by routine USDA sampling and verification testing for Salmonella. The proposal would also require that poultry slaughter establishments develop and implement written procedures to prevent contamination by enteric pathogens throughout the entire slaughter and dressing operations and maintain records documenting those procedures.
  • The bill was introduced the same week that the Government Accountability Office (GAO) issued a report noting that USDA’s Food Safety and Inspection Service (FSIS) had paused work on several microbial adulterant standards to work on the Salmonella framework and recommending that the agency develop a plan to prioritize its proposals and determine which standards are needed.
  • On February 3, 2025, Senator Cory Booker and Representative Rosa DeLauro introduced a bill to provide FDA the authority to collect microbial samples at feed lots during foodborne illness outbreaks or when there is a public health need.
  • The bill is a response to the recent spread of H5N1 (bird flu), as well as persistent foodborne illness risks. According to Rep. DeLauro, the bill, titled the Expanded Food Safety Investigation Act, will “ensure FDA has the power to investigate corporate agribusinesses, respond effectively to public health threats, and protect American consumers.”
  • The goal of the bill, which is endorsed by several non-governmental organizations, is to allow FDA to enter feed lots, which have been linked to outbreaks involving fresh produce due to water runoff adjacent to irrigation canals causing contamination of crops.
  • The full text of the bill is not yet available. Keller and Heckman will continue to monitor the bill, along with other food safety legislation.
  • On January 31, 2025, President Trump signed an executive order titled “Unleashing Prosperity Through Deregulation.”  This order mandates that federal agencies identify at least 10 existing rules, regulations, or guidance documents to repeal whenever they seek to introduce a new rule or regulation.  Additionally, the order stipulates that the Director of the Office of Management and Budget (OMB) will ensure standardized measurement and estimation of regulatory costs.  For fiscal year 2025, the total incremental cost of all new regulations must be significantly less than zero, accounting for offsets from the elimination of costs associated with the ten repealed regulations.
  • The executive order criticizes the costs of regulation, stating that overregulation discourages entrepreneurship, consumer choices, individual liberty, and harms small businesses.  It references Executive Order 13771 which President Trump signed during his first term in which he required agencies to eliminate two regulations for each new regulation issued—a policy rescinded by former President Biden on his first day in office.  The order notes that the Trump Administration had previously eliminated five and a half regulations for every new regulation issued.
  • The order also directs the Director of the OMB to provide agency heads with guidance on implementing the order, including standardizing methods for determining costs.  Furthermore, it revokes OMB Circular No. A-4 (“Regulatory Analysis”) and reinstates the Memorandum of Agreement (MOA) between the Department of Treasury and the OMB from April 11, 2018, regarding the review of tax regulations under Executive Order 12866.
    • OMB Circular No. A-4 provided guidance to federal agencies on developing regulatory analysis, including assessing costs and benefits of regulatory actions.  The revocation of this circular aims to streamline the regulatory process and reduce perceived burdens on businesses.
    • The MOA between the Department of Treasury and the OMB established a framework for reviewing tax regulations, ensuring economic analysis while maintaining timely tax guidance.  Executive Order 12866, signed in 1993, set principles for regulatory planning and review, emphasizing the need for cost-benefit analysis and coordination among federal agencies.
  • This new executive order represents a significant shift in regulatory policy.  Keller and Heckman will continue to monitor any new executive orders issued by the new administration that affect the federal government, particularly those related to the administrative state and regulated industries.
  • Earlier this month, FDA released a summary of a strategy intended to prevent human norovirus and hepatitis A virus (HAV) outbreaks associated with fresh and raw berries. Both norovirus and HAV are types of enteric virus (effecting the gastroenteric system) which have been linked to imported fresh and frozen berries; domestically grown berries have not been linked to an outbreak of these viruses for 35 years.
  • Among the information consulted in developing the plan were the results of 1,558 samples of frozen strawberries, raspberries, and blackberries from November 2018 to September 2023, which showed HAV in 8 samples and norovirus in 10 samples.
  • The pillars of the plan are (1) promoting high compliance rates with FDA’s food safety requirements, (2) encouraging the berry industry to consistently apply pre- and post- harvest sanitation practices, including conducting root cause analysis when failures occur, (3) broadening knowledge regarding the viability, persistence, detection, and mitigation of viruses in fresh and frozen berries, pre- and post-harvest environments, and agricultural water sources, and (4) incentivizing the use of immunization to promote worker health.
  • FDA currently plans to hold a webinar on February 20, 2025, to provide an overview on the updated definition of the nutrient content claim “healthy.”
  • As we discussed on this blog, in December 2024, FDA published a final rule updating the requirements to use the implied nutrient content claim “healthy” on human foods. To make a “healthy” claim, a product must:
    • Contain a certain amount of food from at least one of the food groups or subgroups recommended by the Dietary Guidelines for Americans; and
    • Meet specific limits for added sugars, saturated fat, and sodium.
  • Registration is required to attend the webinar, which is free and open through the day of the webinar. During the webinar, FDA will discuss pre-submitted questions, which must be submitted through the registration page by January 31, 2025.
  • Keller and Heckman will continue to provide updates related to the “healthy” final rule.
  • On January 20, 2025, President Donald Trump signed a memorandum titled, “Regulatory Freeze Pending Review,” imposing a regulatory freeze on all federal agencies.
  • The key points of the regulatory freeze are as follows:
    • Do not Propose or Issue Any New Rules: Agencies cannot propose or issue any new rules in any manner, including sending them to the Office of the Federal Register (OFR), until they are reviewed and approved by a department or agency head appointed by the President.
    • Automatically Withdrawing Unpublished Rules: Any rules that have been sent to the OFR but have not yet been published must be immediately withdrawn to be reviewed by a department head or agency head appointed by the President.
    • Delay Effective Date of Already Published Rules: For rules that have been published but have not yet taken effect, agencies are to consider postponing their effective date for 60 days to review any questions of fact, law, or policy.  During this period, agencies may open a comment period for public input and consider further delaying the rules if necessary.
  • The freeze applies not only to rules but also to any substantive agency action, including Advanced Notices of Proposed Rulemaking (ANPR), Notice of Proposed Rulemaking, notices of inquiry, and any agency statement of general applicability that sets forth a policy on any regulatory or technical issue.
  • This freeze will impact all recently proposed rules by requiring them to undergo a review process, which may lead to the rules being withdrawn, modified, or delayed in implementation.  The following recently proposed rules or finalized but not yet effective rules issued by FDA include:
  • Alongside the regulatory freeze, President Trump has directed federal agencies to temporarily stop all public communications.  This includes press releases, social media updates, and other public statements.  The pause is in effect through February 1.
  • Keller and Heckman will continue to closely monitor any changes made to pre-existing proposed or finalized rules and any new executive orders or rules promulgated by the new administration.