Agricultural Water Compliance DatesHe announced that the FDA issued a proposed rule that, if finalized, would extend the compliance dates for the agricultural water requirements by an additional two to four years (for produce other than sprouts). The new agricultural water compliance date the FDA is proposing for the largest farms is January 26, 2022. Small farms would have until January 26, 2023, and very small farms January 26, 2024. Sprouts, because of their unique vulnerability to contamination, remain subject to applicable agricultural water requirements in the final rule and their original compliance dates.
He agreed that “microbial quality standards for agricultural water are too complicated, and in some cases too costly, to be effectively implemented.” Dr. Gottlieb also announced that “our intention to explore ways to simplify our approach to make compliance less burdensome and less costly, while still being protective of public health.” To give the agency and the farmers more time, he is issuing an extension in the compliance dates” for the agricultural water requirements of the produce rule for non-sprout produce by an additional two to four years. This way the earliest non-sprout compliance date for the water standards won’t be until January 2022.” The proposed extension will give the agency time to take another look at the water standards to ensure that they are feasible for farmers in all regions of the country while protecting public health. The agency has also increased the number of methods that can be used for water testing in agricultural water.
Educational EffortsDr. Gottlieb declared that the agency has recognized a need for additional efforts to educate the produce industry and state regulatory agencies on the new produce safety requirements, and will continue its focus on training, guidance development, and outreach over the next year. This is particularly important since the nation’s farming community has not previously been subject to this kind of oversight. The FDA plans to learn more from farmers, state regulatory partners and other stakeholders about the diverse ways water is used and ensure that the standards will be as practical and effective as possible for all farming operations, during the time extension afforded by the extension.
Produce InspectionThe State Produce Implementation Cooperative Agreement Program that supports 43 states in their development of produce safety programs was awarded $30 million. This funding is in addition to on the nearly $22 million that FDA awarded last year to 42 states to develop produce programs and provide training and technical assistance. Dr. Gottlieb assured the audiences that routine inspections would not begin until 2019. The additional time should be used to focus on issuing guidance that will be helpful to regulators and farmers.
On Farm Readiness ReviewsThe farm readiness review is a voluntary program, where the farms are visited by a team of state officials, cooperative extension agents, and FDA produce experts. The purpose of the visit is to give the farmers information about their readiness to meet the program requirements. The program will also help the FDA to identify training gaps that will be needed to be filled.
TrainingDr. Gottlieb claimed that through Produce Safety Alliance (PSA) 176 farmer training courses had been conducted in 36 states as of June of 2017. More than 1,000 trainers were trained in these courses. NASDA-FDA working group was formed to work on plans for training state and federal inspectors and is finalizing the training modules. FDA is also working with NASDA to determine the best training platforms for ensuring that cooperative extension agents can have the training they need to be effective. Training of state regulators will be a top priority for the FDA in 2018.
Updates: Botulism in Nacho Cheese, Salmonella in Maradol Papaya, Listeria in the Environment, and Our New Trending Page
California Department of Public Health confirms that botulism outbreak was Linked to Retail PracticesIn May we reported on a Botulism outbreak resulting from the consumption of nacho cheese sauce served at the Valley Oak Food and fuel gas station in Walnut Grove, California. The outbreak included 10 cases of laboratory confirmed C. botulinum toxin type A. All patients were hospitalized and one death was reported. Customers spread the nacho cheese sauce on chips from a counter-top self-service warming dispenser. According to a memo from the California Department of Public Health, the operators at the gas station were mainly responsible for the outbreak because the reasons for the outbreak were:
- The bag of nacho cheese (5 lb) collected at the retail location on May 5, 2017, was consumed past the “Best By” date.
- The gas station did not maintain records of the time in which the bag nacho cheese was added to the warming unit. Therefore, the cheese might have been left too long in the warmer.
- The designated tool to open the nacho cheese bag was not used to open the bag of cheese.
Multistate Outbreak of Salmonella Anatum Infections Linked to Imported Maradol PapayasThe CDC reports on the newest outbreak relating to papayas from Mexico. This is the fourth investigation involving to papayas from Mexico this year. On September 4, 2017, the CDC reported that 14 people in 3 states were infected with the outbreak strain of S. anatum. Five hospitalizations and one death resulted from this outbreak. Epidemiological and laboratory data indicated that papaya from Mexico imported by Bravo Produce Inc. of San Ysidro, California is the probable source of the outbreak. On September 10, the FDA and the distributor withdrew the product from the market. The CDC pulseNet data base identified 6 more individuals with the same DNA fingerprint that recently became ill.
Environmental sampling of a plant in Germany linked to Listeria OutbreakWith the increase in environmental sampling mandated by the FSMA, and the numerous recalls resulting from the program, I find it interesting that environmental sampling was inked to a Listeriosis outbreak in Germany. A conveyor belt in a meat processing plant, moving product before packaging, was most likely the source of the contamination. In 2015, an outbreak of Listeriosis was reported in Germany, caused by L. monocytogenes ½ a. In Emerging Infectious Diseases Volume 23, Number 10—October 2017, Molecular Tracing to Find Source of Protracted Invasive Listeriosis Outbreak, Southern Germany, 2012–2016 Kleta et al. using forensic microbiology, had identified several products from one manufacturer contaminated with the outbreak genotype Listeria. Their conclusion was based on the facts that:
- L. monocytogenes outbreak strain was isolated from several products of the same manufacturer
- The outbreak strain was absent in other products collected during the same period
- Epidemiological findings suggested that the source of the outbreak was from this single factory
- The meat processing plant predominantly supplied grocery stores of a single company
- Patience food consumption histories were compatible with the molecular typing results