FDA and Partners in Southwest Growing Region Share Findings from Multi-Year Environmental Study

This study was initiated following a 2018 E. coli O157:H7 outbreak linked to romaine lettuce from the Southwest growing region and represents one of the largest environmental microbiology research efforts to date. Multi-year environmental studies are designed to shed light on environmental conditions that could impact food safety. Having this kind of study helps reinforce the shared commitment to public health through research, science and continuous improvement to promote science-informed food safety practices.

California continues to remain engaged in food safety discussions through the diverse stakeholders represented by the California Agricultural Neighbors (CAN) efforts and by way of the California Longitudinal Study. While the study mentioned below is unique to the Southwest growing region, a One Health approach recognizes the health of people, animals and the environment are intertwined with the goal of achieving holistic health outcomes. You can learn more about California’s One Health efforts related to produce safety on the CDFA Produce Safety One Health Initiatives webpage.

From the U.S. Food and Drug Administration
Constituent Update
June 5, 2024

Today the U.S. Food and Drug Administration updated its website to share preliminary findings from a multi-year environmental study of a specific growing region within the Southwest growing region conducted in partnership with the Arizona Department of Agriculture, and in conjunction with the University of Arizona Cooperative Extension, the Wellton-Mohawk Irrigation and Drainage District (WMIDD), and members of the leafy greens industry. The study sought to better understand the ecology of human pathogens in the environment in the Southwest agricultural region, particularly how pathogens survive, move, and possibly contaminate produce prior to harvest, so that the agricultural community can work together to identify best practices to enhance food safety.

For More Information

Southwest Agricultural Region Environmental Microbiology Study

Click here to view the CDFA Inspection Services Blog with more details about the study and sign up for their mailing list by checking Inspection Service Blog – Latest News from Across the Division.

CDFA Launches Produce Safety One Health Initiatives Webpage

The California Department of Food and Agriculture (CDFA) Produce Safety Program (PSP) announces the launch of a Produce Safety One Health Initiatives webpage dedicated to California’s actions for enhanced produce safety based on the One Health approach.

In response to a series of E. coli O157:H7 outbreaks associated with leafy greens between 2018 to 2020, CDFA launched the California Longitudinal Study (CALS) in 2020 and California Agricultural Neighbors (CAN) in 2021. These actions are part of a collaborative effort across government agencies (federal, state, and local), universities, industry associations, and members of the produce, viticulture, livestock, and compost industries to initiate dialogues, address knowledge gaps, and foster enhanced produce safety practices.

The research efforts taking place in California are based on the globally supported One Health approach, a multidisciplinary systems-thinking approach that recognizes the health of people is interconnected to the health of animals, plants, and our shared environments. The One Health approach is a fundamental component of the national Healthy People initiative, released every decade since 1990 by the U.S. Department of Health and Human Services (HHS), which guides health promotion and disease prevention efforts to improve the health of the nation.

The California Longitudinal Study (CALS) is a multi-year study launched in 2020 targeted towards adaptively identifying environmental factors affecting foodborne pathogens to address knowledge gaps and assist in solutions-oriented outcomes for growers and affiliates in the agriculture industry. To accomplish this, California’s leafy green industry is collaborating with state and federal agencies, the UC Davis Western Center for Food Safety, and partners across California’s cattle, viticulture, and compost industries.

California Agricultural Neighbors (CAN) is a collaborative effort led by CDFA and the Monterey County Farm Bureau (MCFB) launched in 2021 that provides a roundtable forum to foster dialogue and neighborly practices for enhanced food safety when agriculture operations are adjacent to one another. CAN efforts are supported by the California Farm Bureau FederationCalifornia Cattlemen’s AssociationWestern Growers Association, and the California Leafy Greens Marketing Agreement to help with facilitation services provided by Abby Dilley, RESOLVE. The full 2022 CAN Report is available for review here.  

To learn more about California’s Produce Safety One Health Initiatives, please visit https://www.cdfa.ca.gov/producesafety/onehealthinitiatives/.

FDA Publishes Final Rule on Pre-Harvest Agricultural Water

On May 6, 2024, the U.S. Food and Drug Administration (FDA) published a final rule on pre-harvest agricultural water revising certain requirements in Subpart E of the FSMA Produce Safety Rule (PSR) for covered produce (other than sprouts) for enhanced produce safety.

The new rule replaces the prior pre-harvest water microbial quality criteria and testing requirements with requirements for systems-based agricultural water assessments for hazard identification and risk management. Agricultural water assessments will now need to be conducted once annually, and whenever a significant change occurs that increases the likelihood of hazards being introduced to produce or food contact surfaces. The new rule does not change existing agricultural water requirements for sprouts or harvest and post-harvest water uses.

FDA states this new 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.

The final rule is effective July 5, 2024. Compliance dates for the pre-harvest agricultural water requirements for covered produce (other than sprouts) are as follows[1]:

  • For Large farms: April 7, 2025 (9 months after the effective date of the final rule)
  • For Small farms: April 6, 2026 (1 year, 9 months after the effective date of the final rule)
  • For Very Small farms: April 5, 2027 (2 years, 9 months after the effective date of the final rule)

If you have questions about the Produce Safety Rule, please contact producesafety@cdfa.ca.gov.

Additional Resources:

[1] Under the FSMA Produce Safety Rule, farms sizes are classified by the average annual gross produce sales adjusted for inflation over a 3-year period. Click here to learn more about the FSMA Inflation Adjusted Cut Offs. “Large” farms have average annual produce sales above $500,000 adjusted for inflation. “Small” farms have average annual produce sales above $250,000 and up to $500,000 adjusted for inflation. “Very Small” farms have average annual produce sales above $25,000 and up to $250,000 adjusted for inflation.

CDFA Produce Safety Program Launches Phase 1 of the Online PSP Portal Including California Produce Grower Notifications

The California Department of Food and Agriculture (CDFA) Produce Safety Program (PSP) announces the launch of Phase 1 of the Farm Data Repository website, also known as the PSP Portal.

Beginning in April 2024, California produce farms required to comply with the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) Produce Safety Rule will be added into the system on an ongoing, rolling basis. Once added, growers can anticipate receiving a welcome email notification with instructions on how to create an online account and verify their account information.

Growers who receive a welcome email are encouraged to login and verify the information listed for their farm to ensure accurate information regarding their own operations is on file with CDFA PSP.

Questions and technical support requests regarding the PSP Portal can be submitted to producesafety@cdfa.ca.gov.

In January 2024, CDFA PSP announced the development of a new, digital data repository system for California farms and farm inspections to support statewide compliance with the FSMA Produce Safety Rule.

The PSP Portal website will result in California farmers having password-protected access to the data CDFA PSP collects on their farms and operations, including inspection reports and educational communications. Additionally, this system will allow CDFA PSP to efficiently allocate inspection efforts based on food safety risk factors to help ensure a safe and quality food supply for the people of California and beyond. 

Produce Safety Program Offers Flooding Response Resources for California Produce Growers

The California Department of Food and Agriculture (CDFA) Produce Safety Program announces a new Flooding Response Resources section has been added to its PSP Educate webpage.

As seasonal storms are underway, this new section offers several educational resources related to flooding and produce safety on farms. The California agricultural community is encouraged to visit this site regularly as new resources become available.

In Guidance for Industry: Evaluating the Safety of Flood-affected Food Crops for Human Consumption, the U.S. Food and Drug Administration (FDA) defines flooding in the context of produce safety as the flowing or overflowing of water from sources outside a farmer’s control onto lands used to grow, harvest, pack, or hold produce. Flooding events can pose a public health risk as flood waters may contain sewage, chemicals, heavy metals, pathogenic microorganisms, and other contaminants.

If the edible portion of a crop is exposed to floodwaters, it is considered adulterated under section 402(a)(4) (21 U.S.C. 342(a)(4)) of the Federal Food, Drug, and Cosmetic Act and should not enter human food channels. For crops that were in or near flooded areas but whose edible portion did NOT contact flood waters, growers should evaluate the safety of the crops for human consumption on a case-by-case basis for possible adulteration.

If you are impacted by flooding or would like to receive more information on how to respond to flooding with regards to produce safety, please reach out to us at producesafety@cdfa.ca.gov. The CDFA Produce Safety Program can provide technical assistance to California produce growers and can help connect you with experts through the CDFA Technical Assistance Program.

Produce Safety Program Supervisor Discusses Produce Safety Rule Impact on California Farmers in Radio Interview

CDFA Produce Safety Program Regulates the FDA Food Modernization Act

California Department of Food and Agriculture (CDFA) Produce Safety Program (PSP) Supervisor Shelley Phillips was recently interviewed by “Farmer Fred” Hoffman on KSTE radio’s “Farm Hour” program to discuss the impact of the federal Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR) on California farmers.

CDFA created the PSP to “Educate then Regulate” California farmers about the PSR under the authority of the U.S. Food & Drug Administration (FDA), in partnership with the California Department of Public Health (CDPH). FSMA was passed in 2011 to help prevent foodborne illness outbreaks. PSR implementation and enforcement is occurring in stages between 2019 and 2021.

“It’s a way for the FDA to be proactive about food safety rather than being reactive when we have outbreaks or other issues surrounding food safety,” Phillips says about the PSR during the interview.

Items Phillips discusses during the 10-minute interview include:

  • Which farms are required to verify PSR compliance and which farms are PSR exempt
  • What proactive measures farmers are required to follow under the PSR
  • The current stage of PSR implementation and inspections
  • How “small” farmers (average annual sales of $250,000–$500,000 during the previous three-year period) should fill out and submit a recent questionnaire that the CDFA mailed, in order to be prepared for the next stage of PSR inspections
  • What farmers should expect during all stages of a PSP inspection, from initial contact to a follow-up inspection report
  • The educational resources available on www.cdfa.ca.gov/producesafety to help farmers understand and prepare for PSR compliance, including scheduling an On-Farm Readiness Review

“The inspector is there to assist the farmer, so any questions that the farmer may have is fair game,” Phillips says at the interview’s conclusion. 

Click here to hear the full interview.