Dr. Doom and Ms. Gloom have been addressing the fact that both FSIS and FDA are paying more attention to Listeria control in ready-to-eat facilities. In previous blogs, they have discussed facility maintenance and repair as well as employee practices. Doom and Gloom also recommend that facilities that manufacture RTE foods maintain a Listeria Control Program that includes environmental and food contact monitoring. “Testing to find” and taking aggressive measures to eliminate and prevent is the best approach. Doom and Gloom say, “stand guard and keep watch” and don’t let Listeria creep into your process.
FSIS regulations require processors to test for Listeria and have long encouraged the use of “sentinel-type” programs that aggressively look for and eliminate the organism. Best practice is to also include any non food-contact surfaces (NFCS) and product samples collected as part of the routine sampling program (though not required by regulation). Listeria control programs are expected to be designed based on the relative risk of the product. FSIS recommends that establishments investigate, take corrective and preventive actions, and perform enhanced sampling in response to any positive findings, which is also an industry best practice.
FDA does not currently have a regulation similar to that of FSIS which actually requires a manufacturer to test for Listeria monocytogenes (Lm). However, as discussed at the recent Food Safety Advisory meeting held by FDA on Listeria, FDA is reconsidering its 2008 draft guidance requiring firms that detect Listeria species on a food-contact surface to either speciate or assume the Listeria is Lm. FDA is concerned this approach may discourage firms from developing robust environmental monitoring programs.
FDA is now considering adopting the FSIS approach. Under this approach, FDA would recommend that a facility react to a single positive test for Listeria species with investigation into the root cause as well as intensive cleaning and sanitizing. If the follow-up test at the site and surrounding sites are negative during subsequent consecutive production cycles, the facility would return to its normal sampling frequency with no regulatory action. However, if the facility finds Listeria species at that site or nearby sites during the next three production cycles, more intensive corrective and preventive measures would be expected – which could include determining whether the positive species is Lm. While FDA has not as yet updated their Compliance Guidelines; under the final rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, a registered food facility is expected to consider the risk and establish preventive controls accordingly.
Doom and Gloom want to re-emphasize that Listeria Control Programs are a “total package.” Food facilities must consider the environment and equipment, manage employee practices and product and equipment flow, and verify the effectiveness of these controls with a robust testing program. In the event a positive test result is found, the first thing that is required is a root cause investigation into why the particular site or sample was positive. An investigation must be completed for every positive to try to determine how it became contaminated as the first step in being able to prevent it from occurring again. As part of the investigation, additional targeted sampling around the site is also likely to occur. Also included would be a review of equipment, product and personnel flow to determine if Listeria was introduced through one of these movements. Even a drain positive must be investigated in the same manner as Listeria in a drain was likely introduced there by water carrying it from someplace else.
Doom and Gloom suggests – employ a sentry and prevent the entry!
About "Dr. Doom"
Mixed in with the attorneys at OFW Law is the former USDA Food Safety Inspection Service's (FSIS) Administrator, Dr. Barbara Masters. Dr. Masters is a veterinarian who spent eighteen years with FSIS - the final three years as Acting Administrator and Administrator. During her rise to the Administrator's position, Dr. Masters served as the Deputy Assistant Administrator for Office of Field Operations. While in these key leadership positions at FSIS, Dr. Masters' primary focus was on the implementation of science-based policies for the protection of public health. Dr. Masters issued the initial Federal Register Notices for a systematic approach to humane treatment of livestock and poultry.
Dr. Masters was involved in the drafting of the training of inspection personnel on the Hazard analysis and critical control points (HACCP) and Sanitation Standard Operating Procedures (SSOP) regulations. She was the lead of the FSIS HACCP Hotline. In addition, Dr. Masters provided technical review for establishment's hazard analysis, HACCP plans and supporting documentation. She started her career at FSIS as a public health veterinarian that had responsibilities for ante-mortem inspection, sanitation inspection and all post-mortem inspection responsibilities. She has a good understanding of what happens at the in-plant location, because she has spent many of long days working there.
About "Ms. Gloom"
In the attorney ranks at OFW Law, there is only one attorney who would raise a hand if all were asked if they had any "hands-on" experience in the operation of a Townsend "Frank-O-Matic" hotdog maker, producing bean sprouts for use in egg rolls or in managing a food facility sanitation crew. In fact, there are probably no attorneys out there who could raise their hands except Jolyda Swaim.
Prior to law school and OFW Law, Ms. Swaim spent years in the food industry, beginning as a microbiologist and Quality Assurance technician. In these years, she had direct charge of quality assurance, production, sanitation and consumer affair departments at various companies producing products from pickles, sauerkraut and barbeque sauce, to various meat and poultry products, to frozen entrees, egg rolls and pizza to spices and spice blends. Her last position at Sara Lee as Director of Food Safety had her auditing its facilities in the United States and Mexico to ensure facilities producing ready-to-eat products were following best practices in sanitation and product handling.