1 FAC Charge and Questions Mickey Parish, Ph.D. Senior Advisor for Microbiology FDA/CFSAN, Office of Food Safety JIFSAN Advisory Board November 6, 2015

2 1. Determining Whether Food is Ready-to-Eat (RTE) 2. Distinguishing RTE Foods on the Basis of Whether the Food Supports the Growth of L. monocytogenes 3. Control of Listeria monocytogenes in RTE Foods 4. Control of Listeria monocytogenes in Produce Packinghouses 5. Priorities for Sampling 6. Recommendations on Dietary Restrictions for the Most Vulnerable Populations 7. Other Issues Issues under consideration:

Issue: Determining Whether Food is Ready-to-Eat (RTE) Listeria control measures historically address RTE foods. Does not excuse insanitation in establishments that produce foods that are not RTE. FSMA Preventive Controls Rule, § Definitions: “Ready-to-eat food (RTE food) means any food that is normally eaten in its raw state or any other food, including a processed food, for which it is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards.” 3

Issue: Determining Whether Food is Ready-to-Eat (RTE) QUESTION: 1. Should frozen vegetables be considered to be RTE food even if they bear cooking instructions? If not, why not, and what mechanisms could be put in place to prevent illnesses such as those in the 2009 outbreak associated with a refrigerated cookie dough or to prevent illnesses from contaminated frozen foods that may be thawed and consumed without cooking? Are there some frozen vegetables that should not be considered RTE food? If so, what objective criteria would apply in determining which frozen vegetables should not be considered RTE food? Would such criteria be amenable to a decision- tree approach for the purpose of clearly distinguishing a frozen vegetable that is RTE from a frozen vegetable that is not RTE? 4

Issue: Determining Whether Food is Ready-to-Eat (RTE) QUESTION: 2. Should food that appears to be cooked be considered to be RTE food, even if the manufacturer has not processed the food with a “kill step” and labels the food with cooking instructions? Examples of such food include a vegetarian “hamburger” patty that is seared with grill marks; an egg roll with a browned wrapper; and frozen breaded foods (such as breaded seafood) that appear cooked but contain raw or partially cooked foods that require cooking. If not, why not and what mechanisms could be put in place to prevent illnesses from frozen foods that appear to be cooked? 5

Issue: Distinguishing RTE Foods on the Basis of Whether the Food Supports the Growth of L. monocytogenes Other countries with a policy on Listeria in foods have adopted the Codex Alimentarius approach which applies different standards based upon whether the food does or does not support growth of L. monocytogenes. Foods that support growth of L. monocytogenes: Non-detection standard. Absence in 25 gram samples (similar to FDA and FSIS approach) Foods that do not support growth of L. monocytogenes: Allowance of up to 100 Lm cells/g (draft policy announced by FDA in a 2008 draft Compliance Policy Guide– not finalized) 6

Issue: Distinguishing RTE Foods on the Basis of Whether the Food Supports the Growth of L. monocytogenes Most outbreaks occur in foods that support growth of L. monocytogenes. But: There are examples of outbreaks in foods that do not support growth of L. monocytogenes (e.g., recent ice cream outbreak; illness from consumption of fresh stone fruit contaminated with Lm). Other efforts reviewed by FDA include refereed papers of recent years that 1) quantify higher relative risk of listeriosis among vulnerable population subgroups compared to healthy adults, and 2) that estimate substantially higher number of cases from lower doses of Lm than previously thought when Lm strain virulence is considered. 7

Issue: Distinguishing RTE Foods on the Basis of Whether the Food Supports the Growth of L. monocytogenes QUESTION: 3. Should FDA treat the presence of L. monocytogenes differently in RTE foods, depending on whether the food supports the growth of L. monocytogenes? If so or if not, why? 8

Issue: Control of Listeria monocytogenes in Ready-To- Eat Foods According to the PC Rule: A facility that determines L. monocytogenes is a hazard requiring a preventive control would consider measures such as sanitation controls, an environmental monitoring program, and corrective action procedures in its food safety plan. FDA wants to encourage industry to develop a “seek and destroy” mentality and establish robust Listeria control programs; similar to the RTE meat and poultry industry. FDA is considering changing its recommendation in the 2008 draft guidance for industry that a firm should react to a positive Listeria species test on a food-contact surface by either conducting additional tests to determine whether the Listeria species is L. monocytogenes, or making the assumption that the Listeria species is L. monocytogenes. 9

Issue: Control of Listeria monocytogenes in Ready-To- Eat Foods Suggested recommendation: A firm detecting Listeria species on a food- contact surface may engage in cleaning/sanitizing at the positive and surrounding sites, followed by retesting of the site and adjacent sites near the end of each subsequent production run for some period of time. Absence of Listeria species in all tests allows the firm to return to normal monitoring frequency. FDA would remain neutral on whether the firm should determine if the Listeria species positive was due to L. monocytogenes. If the firm again detects Listeria species in one of the subsequent production runs after the first Listeria species positive test, more intensive corrective actions would be appropriate, including possibly determining if the species is L. monocytogenes. 10

Issue: Control of Listeria monocytogenes in Ready-To- Eat Foods QUESTION: 4. Should we change our recommendation regarding when a firm should determine whether the Listeria spp. detected on a food-contact surface is L. monocytogenes? Do you agree with the approach we are considering regarding how a firm should react to a single positive finding of the indicator Listeria spp. on a food-contact surface? If not, why not? Do you have any recommendations for how the approach we are considering could be modified? Should such an approach include specific recommendations such as no more than X such instances within Y time-frame? 11

Issue: Control of Listeria monocytogenes in Ready-To- Eat Foods QUESTIONS: 5. During inspection, FDA may collect large numbers of environmental samples to determine the sanitary status of a firm’s production areas. What, if any, role could the number of samples FDA collects during a routine inspection have in a regulatory policy designed to encourage robust Listeria control programs? For example, should FDA take into account a robust program to control Listeria in the production environment by collecting fewer samples during inspection? 6. Do you have any recommendations for additional policies to encourage development of robust programs to control Listeria in the production environment for RTE foods? 12

Issue: Control of Listeria monocytogenes in Produce Packinghouses Three produce-related listeriosis outbreaks since 2011: L. monocytogenes outbreak strains found in packinghouses. Evidence of resident strains. Cantaloupe Stone fruit Apples (used to make caramel apples) 13

Issue: Control of Listeria monocytogenes in Produce Packinghouses FDA seeks input from FAC on how to encourage packinghouses to control L. monocytogenes. Recently finalized produce safety rule does not establish requirements for environmental monitoring. FDA is strongly encouraging all food establishments that pack fresh produce to take appropriate measures to prevent L. monocytogenes that may be present in the environment from contaminating fresh produce. 14

Issue: Control of Listeria monocytogenes in Produce Packinghouses FDA is currently considering development of guidance documents specifically for the fresh produce packing and handling industry to encourage robust Listeria control programs in packinghouses. FDA will continue outreach activities to ensure that produce packinghouses are aware of their responsibilities to prevent L. monocytogenes from becoming established as a resident in their packinghouse areas where it could contaminate produce that is packed and shipped from their establishments. 15

Issue: Control of Listeria monocytogenes in Produce Packinghouses FDA’s primary short-term interest is in encouraging development of robust Listeria control measures in produce packing and holding establishments; however, FDA is interested in long-term scientific studies to determine the prevalence of L. monocytogenes on produce growing in a field. Although data regarding the level of such contamination are not widely available, our initial presumption is that the level of such contamination would be low. 16

Issue: Control of Listeria monocytogenes in Produce Packinghouses QUESTIONS: 7. Are there studies that could be conducted to distinguish between contamination of produce that might occur in a packinghouse and contamination of produce that might occur in the growing area? 8. What design parameters should be applied in studies to obtain prevalence data for raw produce as a result of contamination in the growing area? For example, should it focus on produce items that are more likely to be contaminated during growing and practices used during growing? What sampling plans would be appropriate? 17

Issue: Priorities for Sampling FDA’s long-standing approach to sampling foods for the presence of L. monocytogenes has been: 1.RTE foods that support the growth of L. monocytogenes are a higher priority for sampling than 2.RTE foods that do not support growth of L. monocytogenes, which, in turn, are a higher priority for sampling than 3.Foods that are not RTE. QUESTION: 9. Do you agree with continuing this approach to sampling foods for the presence of L. monocytogenes? If not, how would you change this approach? 18

Issue: Recommendations on Dietary Restrictions for the Most Vulnerable Populations FDA provides advice and recommendations to consumers on safe food preparation practices, including recommendations to seniors and to pregnant women on foods to avoid to reduce the risk of foodborne illness from consumption of food contaminated with bacterial pathogens. QUESTIONS: 10. What, if any, changes should FDA make to its current dietary recommendations? 11. Is there a need for specific fact sheets targeting special populations (e.g., dieticians, geriatric practitioners, elder care facilities)? 19

Issue: Other Issues This section provides an opportunity for the FAC to address any additional issues that would help FDA in addressing the presence of L. monocytogenes in RTE foods. QUESTION: 12. Do you have any recommendations for additional approaches to achieve the goal of reducing the prevalence of L. monocytogenes in RTE foods? 20

Thank You 21