Innovative Food Defense Program

INNOVATIVE FOOD DEFENSE PROGRAM

Introduction • On/Off switches • Equipment control panels Once a contamination event in refrigerated or frozen • Cleaning tools (brushes, brooms, scrapers) ready-to-eat (RTE) product has been identified, the • Condensate drip pans source of that contamination must be identified. If • Forklifts, hand trucks, trolleys and racks the contaminant is traced to the facility, careful steps • Trash cans must be takenImproving to rid the plant of these Industry adulterants Food• Pallets Emergency for ingredients and product and help prevent their recurrence. These documents are provided as recommendations for activities and Utilities controls to recover from and reduceRecovery the potential for Capacity• Electrical cords and plugs recurrent contamination of RTE foods. The topics • Water hoses and nozzles addressed include: • Compressed air systems including air filters • Ice makers • Personnel • Refrigeration systems including freezers • The design, construction and operation of your • Fans and other air handling equipment plant hd d fl • The design,Guidelines construction and maintenanceon Remediation of Common and Situations Restoration that have resulted in equipment Contamination of RTE Foods • Sanitation Controls There are a number of scenarios that have been This specificof documentFood is Processing provided to give suggestions Facilities after an Intentional identified as having contributed to the microbial for cleaning in response to microbial contamination of contamination of RTE foods. These include but are a RTE food plant. Refer to the definitionsContamination at the end of Event not limited to the following: this document for clarification of the terms involved. • Used equipment is brought from storage and Potential sources of contamination in RTE foods can installed in the process line without thorough include but are not limited to: cleaning Food Contact Surfaces • A new employee who is not properly trained is • Fibrous and porous-type conveyor belts delegated to help clean process equipment • Filling and packaging equipment • Raw or under-processed food is brought into • Work Tables the area where cooked food is held • Belts, peelers and collators • Maintenance workers move from raw areas • Containers, bins, tubs, baskets to finished product areas without changing • Slicers, dicers, shredders and blenders clothes or properly washing their hands • Utensils • Water from a roof leak in a warehouse area • Gloves contaminates the packaging of product constituents which are handled by process Non-contact Surfaces personnel in production area • Floors and walls • Heat exchangers become compromised (have • Sinks, faucets, and water fountains pinhole leaks) • In-floor weighing equipment • Equipment parts, food bins, tubs, etc. are • Air and water hoses cleaned on the floor • Hollow rollers for conveyancesNorth Carolina Department of • AgricultureImproper use & Consumer of footbaths Services • Equipment framework Steve Troxler, Commissioner • Employees arrive for work in contaminated • Open bearings clothes or boots and are not provided with a • Motor housings on equipment change • Maintenance tools (screwdrivers, wrenches) • Standing water on floor DRAFT GUIDANCE INNOVATIVE FOOD DEFENSE PROGRAM

Table of Contents

Module

1. Introduction- Developing Industry Restoration and Remediation Response to Food Emergencies

2. Remediation Strategy

3. Characterize Incident

4. The Sanitation Process, Ingredients, and Storage for RTE Food Plants

5. Sanitary Personnel Practices

6. Cleaners and Cleaning Process

7. Sanitizing and Decontamination

8. Decontamination Analysis and Verification

9. Facility Characterization, Site Containment and Preparation

10. Contaminated Waste Disposal

11. Sanitary Equipment Design

12. Sanitary Food Plant Design and Construction

13. Risk Factors and Communication DRAFT GUIDANDCE INNOVATIVE FOOD DEFENSE PROGRAM

Disclaimer

The preparation of these documents has been The project team consists of: funded by FDA under the Innovative Food Defense Program. The project team wishes to thank Jason Wm. Mark Cosby, MS PhD P. Bashura and William Foust of the FDA Food NCDA&CS Defense Oversight Team for their assistance in (Principal Investigator; the development of these guidelines; also thanks Food & Drug Protection Division) to Tommy Woodard and Melanie Edwards of the NCDA&CS print shop for their contribution to Jim Howard making this publication possible. NCDA&CS (Emergency Programs Division) These documents do not represent the official views of FDA or NCDA&CS and, as such, no Adam Bumgarner product or technology endorsement should be NCDA&CS inferred. (Food & Drug Protection Division) These guidance documents represent the authors’ thinking on current technology, practices Stephanie Ngan and procedures for remediation and restoration NCDA&CS of food processing facilities after a microbial (Food & Drug Protection Division) contamination event. They do not create or confer any rights for or on any person and do not operate Roy Carawan, PhD to bind FDA, NCDA&CS or the public. Professor Emeritus; Department of Food, Bioprocessing, For more information on the Innovative Food and Nutrition Services, Defense Program visit the U.S. Food and Drug North Carolina State University Administrations Website at: www.fda.gov/fooddefense Lynn Turner, PhD Professor Emeritus; Department of Food, Bioprocessing, and Nutrition Services, North Carolina State University

Innovative Food Defense Project Printed August, 2012

Contact Dr. Cosby at 919-733-7366 ([email protected]) for more information

Disclaimer: Funding for this project was made possible, in part, by the Food and Drug Administration through grant 1R18FD004286-01, views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government. DRAFT GUIDANCE INNOVATIVE FOOD DEFENSE PROGRAM 1

Innovative Food Defense Guidelines for Remediation and Restoration of Food Processing Facilities after an Intentional Microbial Contamination Event

Food emergencies of all types, including on public confidence due to government disaster intentional food contamination, can be broken into response is best exemplified by public reaction distinct phases: prevention and preparedness, to the 2001 terrorist attacks. After September 11, detection, response, and recovery. Though anthrax-contaminated letters were sent to various arguably one of the most important elements locations in Washington, D.C., New York and of food emergencies, incident recovery has Palm Beach County, Florida. About 1,114 persons historically been deemphasized and underfunded in Florida and approximately 3300 persons as compared to preparedness and response. in Washington, D. C. were considered at risk and advised to undergo prophylactic antibiotic Smith and Flatt have argued that disaster treatment for 60 days (3, 9). In all, close to 68 recovery is the least understood aspect of hazards persons were infected and/or tested positive for management and the state’s role is vague when anthrax via nasal swab although not all showed compared to federal or local governments (8). symptoms (6). Response and communication to Further, they point out that the lack of a sound, these incidents by the US Postal Service, Public reliable state recovery policy results in poor Health Departments and Centers for Disease recovery outcomes following disasters. Control (CDC) were confusing, incomplete, and Poorly managed recoveries can lead to the closing sometimes contradictory. A deep sense of mistrust of businesses, loss of economic productivity and and confusion for these organizations is harbored employment, and perhaps most importantly, can by many involved in the attacks due to the lack of lead to loss of consumer confidence in a commodity agreement on response, the lack of a consistent or the food supply in general. Additionally, message due to changing opinions of health the public may lose faith in the ability of food professionals, a lack of risk assessment by health regulatory officials to ensure that products in the professionals and overall perceived confusion, marketplace are safe. For example, the spinach lack of focus, poor organization and publicized recalls due to E. coli O157:H7 in 2006-2007 caused lack of agreement between professional health spinach manufacturers unrelated to the recall to groups (3, 7). Clearly, an investment in disaster file for Chapter 11 bankruptcy protection, and the recovery planning is necessary and sorely needed market for all spinach products (regardless of and this holds true for any properly designed Food recall status) declined precipitously (1,5). Indeed, Defense Program. one year after the recall, the spinach industry With this in mind, The North Carolina Department experienced a 350 million loss and a 20 percent of Agriculture & Consumer Services [NCDA&CS] reduction in sales from pre-recall levels (10). Food & Drug Protection Division (FDPD) was Likewise, the tomato (and later peppers) recalls in awarded a grant under the Innovative Food the summer of 2008, finally tracked to Salmonella Defense Projects (R18) of the FDA to develop enterica serotype Saintpaul adulterated peppers guidelines to instruct food processors how from Mexico are estimated to have cost Florida to create a remediation strategy to deal with tomato growers 500 million dollars and caused contamination incidents in their products and an additional loss of 200 million to the produce facilities before such events occur. FDPD has been industry in general as consumer demand dropped actively developing and implementing innovative for fresh produce (2, 4). food safety and defense programs for a period of With unintentional foodborne illness able to cause ten years, including the successful development such widespread economic and social effects, of an all-hazards and interdisciplinary Rapid intentional incidents possess the ability to be Response Team (RRT) also with support from FDA. utterly catastrophic to the safety, security and NCDA&CS believes in proactive and collaborative public confidence of the food supply. The strain initiatives to prevent and mitigate the impact of DRAFT GUIDANCE Innovative Food Defense

food emergencies on North Carolina citizens and to, a violative product will cause serious adverse industries. health consequences or death.” Scope of the Restoration and Remediation Adulterated Foods – Adulteration is a term used to Guidelines – A truly comprehensive set of define food that is unsafe for human consumption. guidelines for the remediation of food processing According to the Food, Drug and Cosmetic Act facilities would encompass all risks due to Section 402 (21USC:342): microbiological, chemical and radiological A food shall be deemed adulterated: contamination. That is beyond the range of this project and therefore the intent of these guidelines • If it bears or contains any poisonous or is to focus on microbiological contamination deleterious substance which may render incidents in the ready-to-eat (RTE) food market. In it injurious to health; but in case the our experience, most Class I recalls are caused substance is not an added substance such by microbiological contamination of RTE foods. food shall not be considered adulterated under this clause if the quantity of such Purpose of the Restoration and Remediation substance in such food does not ordinarily Guidelines – According to the FDA Innovative render it injurious to health; [or] Food Defense Program, “IFDP continually seeks • If it bears or contains any added poisonous to support innovative concepts, projects or or added deleterious substance (other than novel solutions to address gaps in, or provide a substance that is a pesticide chemical enhancement to, food defense efforts nationwide. residue in or on a raw agricultural As we continue to move forward in meeting our commodity or processed food, a food food defense goals by increasing preparedness, additive, a color additive, or a new animal developing response plans, and ensuring we drug) that is unsafe…. have the tools to facilitate recovery, we must also integrate these approaches into our existing • If it bears or contains a pesticide chemical food safety infrastructure”. Consequently, the residue that is unsafe… purpose of these guidelines is to educate the food • If it is or if it bears or contains (i) any food production community of North Carolina in the most additive that is unsafe….or a new animal effective and efficient means to restore production drug (or conversion product thereof) that is capacity after an intentional or unintentional unsafe… contamination event. We have strived to develop a comprehensive framework of information which • If it consists in whole or in part of any filthy, food producers can use to build a restoration/ putrid, or decomposed substance, or if it is remediation plan that will best fit their specific otherwise unfit for food; needs. We feel that this information will be useful to producers in updating their current sanitation • If it has been prepared, packed, or held and decontamination sanitary SOP to facilitate under insanitary conditions whereby it reducing the risk of contamination during day to may have become contaminated with filth, day operation. or whereby it may have been rendered injurious to health; Legal Parameters of Recalls of • If it is, in whole or in part, the product of a Adulterated Foods diseased animal or of an animal which has died otherwise than by slaughter; In accordance to FDA Investigations Operations Manual (IOM), Chapter 7.1, a recall is: • If its container is composed, in whole or “A firm’s removal or correction of a marketed in part, of any poisonous or deleterious product that FDA considers to be in violation of substance which may render the contents the laws it administers, and against which the injurious to health; Agency would initiate legal action (e.g., seizure). The complete definition can be Recall does not include a market withdrawal or a reviewed at: http://www.fda.gov/ stock recovery. See Agency recall policy outlined RegulatoryInformation/Legislation/ in 21 CFR 7.1/7.59 – Enforcement Policy (Including FederalFoodDrugandCosmeticActFDCAct/ Product Corrections) – Guidance on Policy, FDCActChapterIVFood/ucm107527. Procedures and Industry Responsibilities.” htm?utm_campaign=Google2&utm_ A Class I recall is: “a situation in which there is a source=fdaSearch&utm_medium=website&utm_ reasonable probability that the use of, or exposure term=adulterated&utm_content=10#ftn2 2 DRAFT GUIDANCE Innovative Food Defense

In general, any RTE-food that contains a pathogen • Monitor the resumption of commodity will be deemed “adulterated” because the production and testing and validation of pathogen is considered an added “poisonous or product safety and wholesomeness deleterious substance which may render it injurious to health”. Once a food is deemed adulterated, • Monitor marketing, public relations and FDA and FSIS have the legal power to seize and consumer outreach once the facility is condemn the product, prevent the facility from operational manufacturing or distributing the product and Recovery Model Module Design detain any imported product. In addition, Section 206 of the Food Safety Modernization Act passed The development of any recovery process will in January, 2011 now gives federal officials the depend on numerous and specific factors unique authority to demand mandatory product recalls if to a particular incident and therefore the recovery the firm refuses to recall voluntarily. process designs presented in these modules attempt to encompass as many food defense Restoration and Remediation Guidelines and food safety scenarios as feasible. Our goal is that these modules be generic enough to be The goal of any recovery process is to used by any federal, state or tribal institution decontaminate, rehabilitate and restore food required to respond to an event, but to also processing facilities and salvageable equipment contain information on the latest technology of and reinstate the consumer’s confidence in the cleaning, sanitation, and remediation of food food product(s) and companies affected. Some processing facilities. These modules will focus on objectives to be addressed are: microbiological incidents. The guidelines in these • Ensuring that safety of all workers involved modules are subject to change as the technology and risks to other persons and the of equipment, analytical procedures, sanitation, environment are minimized and decontamination advances. Below are some important factors to be considered when • Work hand-in-hand with law enforcement designing recovery/remediation models: authorities in case the incident may be a bioterror or other intended action Characterize Incident – intentional (Food Defense) or unintentional (Food Safety) • Select the most appropriate cleaning/ sanitation methods for the facility; Characterization of agent (partially accomplished determined by type of contamination, during response phase) building materials in the facility and food • Virulence commodity • Environmental persistence • Susceptibility to inactivation • Ensure the contaminant is not further spread during the recovery Effected site/facility characterization • Enclosed /Semi-enclosed: types of building • Determine the most likely cause of materials and surfaces at effected site contamination and evaluate production • Plumbing systems process, equipment, and/or security • HVAC systems changes and improvements to lessen the • Extent of equipment effected risk of a second incident • Refrigeration or freezer storage of raw materials or product • Ensure that the facilities, equipment and • Cleaning/Sanitation procedures; wet or dry other infrastructure are returned to working • Food product; Ready to eat or preparation conditions as good as or better than the required conditions prior to the incident Possible route of exposure and entry to facility • Facilitate the start up of the facility once • Airborne decontamination measures have been • Water validated and verified • Raw materials • Confirm that all waste materials, • Pest contaminated raw ingredients or product, • Workers/visitors supplies and/or equipment are properly Site containment and preparation and safely disposed • Secure contaminated areas and limit access to required personnel

3 DRAFT GUIDANCE Innovative Food Defense

• Install temporary walls to isolate areas as • Ascertain time and costs required to required complete decontamination process • Assemble worker decontamination unit • Communicate the decontamination • Install air handling and testing units as process with employees and media required • Establish defined offsite area for cleaning Remediation Strategy items removed from contaminated area The remediation strategy is the overall plan • Establish defined area for short term including site preparation and containment, storage of supplies and waste components clearance goals, decontamination, and safety in addition to: Risk factors at site • Decontamination verification • Determine the virulence of the contaminant • Waste disposal and risk of infection to personnel at the site • Environmental sampling and analysis to • Determine the safety risks of any chemicals confirm clearance goals or equipment to be used during the • Present all pertinent data to federal, state restoration process and local officials for approval to open • Determine level of PPE required for facility personnel • Advise on long term facility enhancements • Establish standard work zone for worker and renovations (i.e., security, air handling, protection and to limit accidental spread of raw material storage, employee hygiene the contaminant practices) Risk Communication The authors hope the material presented in these • Establish Information Center to develop guidelines will aid food processors in developing and release information to employees and strategic plans for remediation of their facility in media the event of contamination and also help them • Characterization Environmental Sampling develop or improve sanitary procedures currently and Analysis Plan in place to reduce the risk of contamination. • Specify minimum number of samples to adequately determine extent of contamination • Ensure laboratory capacity for testing all samples • Ensure proper chain of custody and data processing Clearance Goals • Clearance goals are the goals and predictions of what exactly is the expected result after the remediation process. These goals should be designed before any work begins to insure that residual risks are reduced to levels consistent with risk management rationales as determined by state, federal, and local officials Decontamination Plan • Identify areas requiring decontamination (i.e., entire facility or specific areas in facility) • Identify proper cleansers, sanitizers and equipment required • Determine proper conditions for effective decontamination (i.e., contact time, temperature) • Identify toxicities of decontamination chemicals and proper handling and use • Determine requirements for verification of decontamination process 4 DRAFT GUIDANCE Innovative Food Defense

Innovative Food Defense Project Team

The project team consists of:

Wm. Mark Cosby, MS PhD NCDA&CS (Principal Investigator; Food & Drug Protection Division)

Jim Howard NCDA&CS (Emergency Programs Division)

Adam Bumgarner NCDA&CS (Food & Drug Protection Division)

Stephanie Ngan NCDA&CS (Food & Drug Protection Division)

Roy Carawan, PhD Professor Emeritus; Department of Food, Bioprocessing, and Nutrition Science, North Carolina State University

Lynn Turner, PhD Professor Emeritus; Department of Food, Bioprocessing, and Nutrition Science, North Carolina State University

Support This worked was funded by the FDA Innovative Food Defense Program. The project team wishes to thank Jason P. Bashura and William Foust of the FDA Food Defense Oversight Team for their assistance in the development of these guidelines.

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References 8. Smith, G. and V. B. Flatt. Assessing the Disaster Recovery Planning Capacity of the State 1. Associated Press. 2007. Safety concerns follow of North Carolina. Institute for Homeland Security E. coli outbreak. Los Angeles Times. Solutions. January 2011. http://articles.latimes.com/2007/feb/05/business/ https://www.ihssnc.org/portals/0/Documents/ fi-vegsurvey5 VIMSDocuments/IHSS_Research_Brief_S mith.pdf 2. Bayles, T. 2008. Tomato growers fault FDA for losses. Sarasota Herald-Tribune. 9. Treager, M. S., S. T. Wierma, N. E. Rosenstein, J. http://www.heraldtribune.com/article/20080701/ M. Malecki, C. W. Shepard, P. T. BUSINESS/178192014/1537 Raghunathan, S. P. Pillai, T. Popvic, C. P. Quinn, R. F. Meyer, S. R. Zaki, S. Kumar, S. M. 3. Blanchard, J., Y. Haywood, B. D. Stein, T. L. Bruce, J. J. Sejvar, P. M. Dull, B. C. Tierney, J. D. Tanielian, M. Stoto, and N. Lurie. 2005. In Jones, B. A. Perkins, and the Florida Their Own Words: Lessons Learned From Those Investigation Team. 2002. First Case of Exposed to Anthrax. Amer. J. Public Bioterrorism- Related Inhalational Anthrax in Health. 95(3) 489. the United States, Palm Beach County, Florida, 2001 Emerg. Infect. Dis. 8(10) 1029. 4. CBS News. 2008. Report: Tainted Peppers Didn’t Alarm FDA. 10. Weise, E and J. Schmit. 2007. Spinach recall: 5 http://www.cbsnews.com/stories/2008/08/19/ Faces. 5 agonizing deaths. 1 year later. health/main4361625.shtml USA Today. http://www.usatoday.com/money/ industries/food/2007-09-20-spinachmain_ 5. Chediak, M. 2006. Spinach recall tips broker N.htm into Chapter 11. Orlando Sentinel. http://articles.orlandosentinel.com/2006-10-18/ business/SPINACH18_1_1_spinachcommissary- agency-defense-commissary

6. Cymet, T. C. and G. Kerkvliet. 2004. What is the True Number of Victims of the Postal Anthrax Attack of 2001? J. Amer. Osteopath. Assoc. 104(11) 452.

7. Quinn, S. C., T. Thomas, and S. Kumar. 2008. The Anthrax Vaccine and Research: Reactions from Postal Workers and Public Health Professionals. Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 6(4) 321.

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Notes

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Notes

Innovative Food Defense Project

Contact Dr. Cosby at 919-733-7366 ([email protected]) for more information

8 DRAFT GUIDANCE 2 INNOVATIVE FOOD DEFENSE PROGRAM

Remediation Strategy

Remediation strategy is the overall plan for the the outcomes described in subsection (c) restoration of a food facility after a contamination shall be achieved…” event has occurred. In Section 103 of the Food Safety Modernization Act, it states: In addition, the act also specifies corrective actions that must be taken in Section 103 (e): “(a) In General. - The owner, operator, “The owner, operator, or agent in charge of a or agent in charge of a facility shall, in facility shall establish procedures to ensure accordance with this section, evaluate that, if the preventive controls implemented the hazards that could affect food under subsection (c) are not properly manufactured, processed, packed, or held implemented or are found to be ineffective— by such facility, identify and implement ‘‘(1) appropriate action is taken to reduce the preventive controls to significantly minimize likelihood of recurrence of the implementation or prevent the occurrence of such hazards failure; ‘‘(2) all affected food is evaluated for and provide assurances that such food is safety; and ‘‘(3) all affected food is prevented not adulterated…” from entering into commerce if the owner, operator or agent in charge of such facility ‘‘(b) Hazard Analysis.—The owner, cannot ensure that the affected food is not operator, or agent in charge of a facility adulterated….” shall— And finally, the act specifies verification of ‘‘(1) identify and evaluate known or corrective actions: reasonably foreseeable hazards that may be associated with the facility, including— ‘‘(f) Verification.—The owner, operator, or agent in charge of a facility shall verify ‘‘(a) biological, chemical, physical, and that— radiological hazards, natural toxins, pesticides, drug residues, decomposition, ‘‘(1) the preventive controls implemented parasites, allergens, and unapproved food under subsection (c) are adequate to and color additives; and control the hazards identified under subsection (b); ‘‘(2) the owner, operator, ‘‘(b) hazards that occur naturally, or may or agent is conducting monitoring in be unintentionally introduced; and ‘‘(2) accordance with subsection (d); ‘‘(3) identify and evaluate hazards that may be the owner, operator, or agent is making intentionally introduced, including by acts appropriate decisions about corrective of terrorism; and ‘‘(3) develop a written actions taken under subsection (e); ‘‘(4) analysis of the hazards. the preventive controls implemented ‘‘(c) Preventive Controls.—The owner, under subsection (c) are effectively and operator, or agent in charge of a facility significantly minimizing or preventing shall identify and implement preventive the occurrence of identified hazards, controls, including at critical control including through the use of environmental points…” and product testing programs and other appropriate means…” ‘‘(d) Monitoring of Effectiveness.—The owner, operator, or agent in charge of a In short, the Food Safety Modernization Act facility shall monitor the effectiveness of specifies that food processors, in addition to the preventive controls implemented under preventative plans, must also develop restoration/ subsection (c) to provide assurances that remediation plans to be implemented in case of DRAFT GUIDANCE Remediation Strategy

a contamination event. It is the sole responsibility and sanitation? Is an analysis of total of the “owner, operator, or agent in charge of a bacterial load in the facility even required, facility” to ensure plans are developed and put in or is demonstration and verification of place before a contamination event occurs. These sound cleaning and sanitizing procedures guidelines are intended to cover all aspects of sufficient? What are the specific remediation planning and assist food processors requirements of local, state and federal in the development of these plans. officials to insure the remediation process is complete? What are the requirements Who Should Follow The Guidance in these for waste storage and disposal? Documents? Clearance goals should be designed to A remediation strategy plan is ultimately the insure that residual risks are reduced to responsibility of the owner(s) of RTE-food levels consistent with risk management processing facilities. Facility managers, quality rationales as determined by state, federal, assurance and quality control personnel should and local officials and approved by those initiate and develop the plan and would benefit officials before work begins. by following the guidance documents in this Characterization of contamination agent series. Facility supervision personnel should provide training sessions for all employees in the • Bacteria, virus, sporeforming bacteria, or implementation of preventative and remediation parasite plans adopted. It is our hope that all RTE-foods • Virulence processors will benefit from following these • Environmental persistence recommendations to help avoid the product • Susceptibility to inactivation contamination/plant closure scenario. Effected site/facility characterization How Do these Documents Relate to the FDA GMPs and Other Regulations? • Enclosed /Semi-enclosed: types of building materials and surfaces at effected site These documents are not meant to supersede • Plumbing systems any FDA guidelines, requirements or • HVAC systems recommendations. The guidance and • Extent of equipment effected recommendations in this and all accompanying • Refrigeration or freezer storage of raw documents are meant to compliment those of materials or product current GMPs and the newly adopted Food Safety • Cleaning/Sanitation procedures; wet or dry Modernization Act. Any regulations currently • Food product; Ready to eat or preparation required by FDA must be followed. required Aspects of the Remediation Strategy Possible route of exposure and entry to facility Characterize Incident – intentional (Food Defense) • Airborne or unintentional (Food Safety) • Water • Raw materials • If intentional contamination is suspected, • Pest law enforcement officials must be • Workers/visitors consulted and any restoration process • Poor building structure must be approved by law officials in charge before any action can take place. Site containment and preparation This is required to insure that any evidence • Secure contaminated areas and limit of intentional contamination be preserved access to required personnel for future prosecution • Install temporary walls to isolate areas as required Clearance Goals • Assemble worker decontamination unit • Install air handling and testing units as • Clearance goals are the goals and required predictions of what exactly is the expected • Establish defined offsite area for cleaning result after the remediation process. For items removed from contaminated area example, while pathogen elimination • Establish defined area for short term is expected, complete sterility in the storage of supplies and waste components facility is unachievable. So, what is the expected bacterial load after cleaning 2 DRAFT GUIDANCE Remediation Strategy

Risk factors at site Waste Disposal • Determine the virulence of the contaminant • Insure that all contaminated product, and risk of infection to personnel at the site equipment, and cleaning and sanitization • Determine the safety risks of any chemicals supplies are disposed of in a manner or equipment to be used during the that meets all local, state, and federal restoration process requirements • Determine level of PPE required for personnel Records and Data Management • Establish standard work zone for worker • It is vital that all records pertaining to protection and to limit accidental spread of the remediation process, including the contaminant daily logs of personnel and equipment Risk Communication sanitation, PPE use, proper storage and • Plan for an Information Center to develop disposal of cleaning/sanitation equipment and release information to employees and and supplies, storage and disposal of media contaminated product, and cleaning and decontamination sampling results but Characterization of Environmental Sampling and kept in an easily accessible format for Analysis Plan presentation to federal, state and local officials for approval to open facility • Determine type of sampling required to achieve the clearance goals These recommendations are not meant to be • Specify minimum number of samples all-inclusive but rather a starting point for facility to adequately determine extent of owners, managers and supervisors to develop contamination and verification of their own remediation strategy which will fit their decontamination particular needs. • Ensure laboratory capacity for testing all samples • Ensure proper chain of custody and data processing Decontamination Verification • Insure that all decontamination procedures are verified according to the Food Safety Modernization Act Section 103 (f) and have been approved by all relevant local, state, and federal officials

3 DRAFT GUIDANCE Remediation Strategy

Notes

Innovative Food Defense Project

Contact Dr. Cosby at 919-733-7366 ([email protected]) for more information

4 DRAFT GUIDANCE INNOVATIVE FOOD DEFENSE PROGRAM 3

Characterize Incident

Once a contamination event has been discovered 1. Is the contamination incident and traced to your food processing facility, the accidental or intentional (bioterrorism) incident must be characterized so that the proper response can be activated as soon as possible, Determining whether the incident was after securing the facility and any suspected accidental or intentional is difficult but very contaminated product. This may encompass important in determining the restoration/ many aspects but the main features are; 1) is the remediation process. If accidental, the incident accidental or intentional (bioterrorism) processor can use their remediation plan in 2) identity of contaminant, 3) What is the route accordance with their established sanitary of entry to the facility 4) What is the contaminant SOP and advice from local, state and federal distribution in the facility, 5) is the contaminant officials. If an intentional contamination is commonly or rarely found in your type of product, suspected, law enforcement officials must be 6) Is contaminant distribution sporadic, seasonal consulted and any restoration process must be or uniform, 7) What practices (or lack thereof) may approved by law officials in charge before any have contributed to the contamination event. action can take place. This is required to insure that any evidence of intentional contamination Who Should Follow The Guidance in these be preserved for future prosecution. Documents? 2. Identify the contaminant Characterization of the contamination incident is just one part of the remediation strategy plan and Foodborne/Waterborne Gram is ultimately the responsibility of the owner(s) of negative pathogenic bacteria. RTE-food processing facilities. Facility managers, quality assurance and quality control personnel These organisms are non- should initiate and develop these plans and would sporeforming but can persist in a benefit by following the guidance documents in dormant, non-growing state for years this series. Facility supervision personnel should in soil and on surfaces. They also have provide training sessions for all employees in the a low infective dose. implementation of preventative and remediation Salmonella - Common in all plans adopted. It is our hope that all RTE-foods animals, raw meats, poultry, processors will benefit from following these seafood. Raw vegetables, nuts and recommendations to help avoid the product spices are also carriers, probably contamination/plant closure scenario. due to environmental or human contamination. Environmental How Do these Documents Relate to the FDA reservoirs include soil, water, fecal GMPs and Other Regulations? matter, insects and other pests. These documents are not meant to supersede Salmonella may contaminate a variety any FDA or USDA guidelines, requirements of foods including Ready-to-Eat (RTE) or recommendations. The guidance and items such as cream-filled desserts recommendations in this and all accompanying and toppings, spices, dried soups, documents are meant to compliment those of peanut butter, cocoa, and chocolate. current GMPs and the newly adopted Food Safety Salmonella typhi and paratyphi are Modernization Act. Any regulations currently particularly important since they can required by FDA or USDA must be followed. cause typhoid fever and humans are the only known host. DRAFT GUIDANCE Characterize Incident

Campylobacter – Common to livestock Staphylococcus aureus – and poultry, other wild and domestic Staphylococcal food poisoning animals but also found in shellfish, is caused by toxins produced by water and unpasteurized milk. the organism when the population Campylobacter may not survive as reaches about 100,000 bacteria per long as Salmonella on environmental gram of food. Growth and toxin surfaces. Wild and domesticated production will occur when foods are animals serve as reservoirs of held between 45oF and 140oF. The contamination as well as sediment, toxin is highly heat resistant and holding ponds, and agricultural infectious dose can be as low as 1.0 watersheds. microgram. Humans and animals are the primary contamination sources Shiga Toxin producing E. coli (STEC)– Also but the organism can also be found called enterohemorrhagic E. coli or in dust, air, water, sewage, equipment EHEC, the most widely known being E. and surfaces. Poultry, meat and egg coli O157:H7. This organism is common products are commonly involved in livestock and wild animals, raw or in staphylococcal food poisoning. undercooked meats. Also found in This includes RTE products such as seed/bean sprouts, lettuce, sausages, delicatessen salads and sandwiches cheese and raw milk. Environmental (egg, tuna, macaroni, etc.), cream reservoirs include soil, water, fecal filled bakery items (éclairs, cream pies, matter, insects and other pests. Further, etc.) and dairy products. Any foods in 2012 the FSIS started requiring meat that require a lot of handling during processors to test for six non-O157 preparation and held at improper STEC serogroups; O26, O45, O103, temperatures are prime candidates for O111, O121 and O145. Staphylococcal food poisoning. Other bacteria in this group include Shigella (water and raw vegetables), Foodborne/Waterborne sporeforming Vibrio (water, fish & shellfish), and bacteria. Yersinia (water, soil, animals, meats, Bacillus cereus – B. cereus food and seafood) poisoning can be caused by one of Foodborne/Waterborne Gram positive two toxins produced in temperature abused foods. Toxin production pathogenic bacteria. is suspected when the population These organisms are also non- exceeds 1,000,000 bacteria per gram sporeforming but can persist in a of food. Meats, milk, fish, vegetables, dormant, non-growing state for years and rice are associated with this in soil and on surfaces. type of food poisoning. Prepared RTE foods such as sauces, puddings, Listeria monocytogenes – Many birds gravies, pasta, salads, soups, and and mammals (including humans) casseroles are common sources of B. can be carriers of L. monocytogenes. cereus intoxication. As a sporeformer, It can contaminate a variety of foods B. cereus is widespread in the including RTE items as smoked environment, found in soil, sediments, fish, prepared salads, cheese, vegetation, insects and animals, and sprouts, cooked meat, poultry, and cereal grains. delicatessen meats. Also found in milk, raw vegetables and ice cream. Clostridium perfringens – Perfringens Environmental reservoirs include food poisoning most often occurs in soil, water, and feces. It can grow institutional settings (nursing homes, at refrigerated temperatures which schools, prisons, etc) but can occur in make it especially important in any product when large quantities of medium to long shelf life RTE foods. food are prepared and improperly held o o L. monocytogenes causes 19% of all between 45 F and 140 F for several deaths attributed to foodborne illness. hours. This allows the organism to grow to large numbers (about 1.0 – 0.1 million per gram food). Once ingested, 2 DRAFT GUIDANCE Characterize Incident

the organism produces toxin in the Foodborne/Waterborne parasites gut causing abdominal cramps and The four food and waterborne diarrhea. Common food sources are protozoan parasites found in the fish, poultry, soups, gravies, meat United States are Toxoplasma, roasts, stews, and dried soups/gravy Cryptosporidium, Cyclospora and mixes. Widely distributed in soil, water Giardia (Entamoeba is common sediments, compost, and decaying in tropical and subtropical Central vegetation. Humans, animals and America and Mexico). Any of these insects can carry the organism in their parasites can be found in soil and gastrointestinal tracts. water contaminated with human or animal feces in a resistant cell form Clostridium botulinum – Botulism, similar to bacterial spores called caused by a neurotoxin produced in cysts or oocysts which can survive food by C. botulinum is rare but its many months. The elderly, young, mortality rate is high. Thus, suspected and immunocompromised persons presence of the organism or neurotoxin are particularly susceptible to severe in food will cause an immediate illness and death from these parasites. response by federal, state, and local In fact, Toxoplasma gondii causes 24 officials. The toxin is heat sensitive % of all deaths attributed to foodborne and will be destroyed when food is illness. Also, in 1993 Cryptosporidium heated to 80oC (176oF) for 10 minutes contaminated the drinking water of or more. Low acid, home canned food Milwaukee, WI resulting in 400,000 products are the common source of illnesses and at least 100 deaths of the poisoning but inadequately processed elderly and AIDS patients. commercial foods have been involved in outbreaks and recalls. Canned Many humans and animals can be vegetables, meat products, vegetable asymptomatic carriers which makes flavored oils, and seafood are most fecal contamination of soil and water often the cause of the disease. so important. Contamination of food Spores of C. botulinum are common occurs by infected food handlers, throughout the environment including fields treated with livestock slurry soil and sediments. or manure, contaminated irrigation, wash, and rinse waters. Common Foodborne/Waterborne viruses foods associated with protozoan Norovirus – Norovirus food parasites are produce; raspberries contamination can occur during and other berries, lettuce, fresh herbs; harvest (fruits and vegetables) unpasteurized fruit juices and milk. contamination, during preparation Toxoplasma can also be found in by an infected food handler (RTE- muscle tissue of livestock and other foods) or contaminate shellfish animals; pork is considered a main through infected water. Some persons source of human infection. may be asymptomatic during their 3. What was the route(s) of entry of the infection which can increase the risk of contamination by food handlers. contaminant into the facility Norovirus is estimated to cause 11% of There are many ways a contaminant can all deaths due to foodborne infection. enter a facility and establish itself into microbial niches. Hepatitis A – Hepatitis A virus can • Raw goods and ingredients – Any survive in water and surfaces for days ingredient should be considered a possible to months. Similar to Norovirus, foods contaminant carrier, especially if it is not are most often contaminated by an subject to a “kill-step”. infected food handler. Ice, water, fruits, • Transport equipment – this includes vegetables, shellfish, and take-out forklifts, pallet jacks, hand trucks; foods are common sources of infection. essentially anything with wheels. This is Hepatitis A does not become a chronic especially important if these conveyances infection as does hepatitis B and C. move between “post-kill” and “pre-kill”

3 DRAFT GUIDANCE Characterize Incident

areas such as raw storage areas, loading 4. Dispersal of contaminant in facility docks, etc. Plastic and wooden pallets are Once a contaminant has gained entry to a prime source for contamination. the facility it can be dispersed and spread • Tools – Maintenance tools and throughout the installation by a number of toolboxes can be a significant source of ways. contamination, particularly if they are moved around the facility from raw goods • Traffic: employee and equipment – areas to finished product areas. This Contamination can spread to different includes ladders, brooms, squeegees, areas of the facility depending on the fatigue rugs, mops and buckets. traffic flow within. It is very common to have contaminants in the raw storage • Personnel/visitors – Anyone entering the area carried to finished product areas facility is capable of bringing contaminants if foot and/or vehicular traffic is allowed in, inadvertently, or purposefully in the to flow in that direction. Likewise, tools case of a bioterrorism event. They can used in a contaminated area can carry be carried on shoes, clothing, handbags, contamination wherever they go. jewelry, and briefcases. This can be • Sanitation practices – Pressurized air or especially true for outside maintenance water hoses can easily dislodge organisms contractors when bringing in tools and from contaminated areas and spread equipment to the facility. them throughout the room. Contaminated brooms, mops, squeegees and standing • Pests – Birds, rodents, and insects water are particularly important factors • Air flow – air flow from raw storage/ in dispersal. Improper employee hand processing areas to finished processing sanitation also disperses contamination. areas creates a risk of contamination • Air flow – Improper air flow can carry a as does unfiltered air intake from the contaminant throughout the installation. environment. This includes any floor or wall-mounted fans used for cooling product or • Water – Any water supply is suspect temperature control. to carrying contaminants; wash and rinse water for sanitation or product 5. Is the contaminant rare or common in rinses (fruits/vegetables) and water in the food product holding/cooling tanks are vulnerable to contamination. Municipal or local well Determining the commonality of a water can transport contaminants into the specific contamination in a product facility. Sewage water from drains or other will help determine the source of the plumbing backflow is especially suspect. contamination. For example: Listeria is a fairly common contaminant • Poorly maintained facility – Leaky roofs, in RTE-products produced in a wet- improper plumbing and air handling, loose clean facility but not common in bakery or insecure doorjambs, roll up door or products (without dairy ingredients). windows, cracked concrete and flooring. For example, L. monocytogenes Emergency or auxiliary doors in routine contamination of flour tortillas may use to enter or exit the facility. point to contamination via handling. • Facility construction – Any construction Cryptosporidium is often associated within the facility involving cutting floors, with irrigation and wash/rinse water walls, air ducts, pipes and ceilings or in the food industry and raw fruits or replacing equipment is liable to disturb vegetables or products containing protected sites in the facility where raw fruits or vegetables are at higher contaminants have lain dormant for years. risk of Cryptosporidium contamination than most other products. Therefore, a Cryptosporidium outbreak in cheese (made from pasteurized milk) would be considered rare and again, food handling or water within the facility would be suspects of the contamination.

4 DRAFT GUIDANCE Characterize Incident

References 6. Is the contaminant seasonal, uniform or sporadic Hoxie, N. J., et al. (December 1997), The time frame of the contaminant’s “Cryptosporidiosis-Associated Mortality Following appearance may have a bearing on a Massive Waterbome Outbreak in Milwaukee, the remediation strategy. For example, Wisconsin”, American Journal of Public Health 87 a seasonal contamination may point to (12): 2032–2035, PMC 1381251 a problem with raw product. Sporadic appearances could suggest the Scallan E, Hoekstra RM, Angulo FJ, Tauxe RV, contaminant is already established in Widdowson M-A, Roy SL, et al. Foodborne the facility and certain maintenance or illness acquired in the United States—major other procedures are disrupting areas pathogens. Emerg Infect Dis 2011 Jan [date cited]. where it has laid dormant, possible for http://dx.doi.org/10.3201/eid1701.P11101 DOI: years. 10.3201/eid1701.P11101

7. What production practices may have FDA Bad Bug Book. http://www.fda.gov/Food/ contributed to the contamination FoodSafety/FoodborneIllness/

Once the contaminant and possible Micro-organisms in Foods 6. Microbial Ecology entrance routes have been identified, of Food Commodities. 2010. 2nd edition. a team of facility employees should International Commission on Microbiological be appointed to review production Specifications for Food (ICMSF). Kluwer to identify what practices (or lack Academic/PlenumPublishers“ Estimates of thereof) caused the contamination. Foodborne Illness in the United States”. Centers This should begin as soon as possible for Disease Control and Prevention (CDC). http:// since the conclusions will have www.cdc.gov/foodborneburden/ immediate impact on sanitation and decontamination procedures and the Parasites and Foodborne Illness. 2011. USDA/FSIS entire remediation strategy. fact sheet. http://www.fsis.usda.gov/Factsheets/ Parasites_and_Foodborne_Illness/index.asp#7 Definitions Kill step – a cooking, fermentation, acid or alkali treatment, or pasteurization step in the food processing protocol that will eliminate pathogens.

5 DRAFT GUIDANCE Characterize Incident

Table1. Contaminant Identification

Biocides Organism Common Food Vehicle Reservoirs (Sanitizers)*

Foodborne/Waterborne Gram negative pathogenic bacteria

Salmonella Animals, raw meats, Livestock, poultry, and Chlorine compounds poultry, seafood. Raw wildlife, soil, water, fecal and iodophors effective, vegetables, nuts and matter, insects and other but activity decreased by spices pests residual soils and very pH dependent. Chlorine Ready-to-Eat (RTE) items dioxide very effective such as cream-filled but worker safety an desserts and toppings, issue. Quaternary spices, peanut butter, ammonium compounds cocoa, and chocolate. (QAC), ozone, hydrogen peroxide, and peracetic acid also effective. Peracetic acid may also help remove biofilms.

Campylobacter Livestock and poultry, Livestock, poultry, and See Above wild and domestic wildlife, sediments, animals, shellfish, water manure holding ponds, and unpasteurized milk and agricultural watersheds

Shiga Toxin Livestock, raw or Livestock, wildlife, soil, See Above producing E. coli undercooked meats, water, fecal matter, (EHEC ) seed, bean sprouts, insects and other pests lettuce, sausages, cheese and raw milk

Shigella Raw vegetables Water See Above

Vibrio Fish & shellfish Water See Above

Yersinia Animals, meats and Water and soil See Above seafood

*Effectiveness of any sanitizer is dependent on the type of surface being sanitized, temperature, humidity, and pH.

6 DRAFT GUIDANCE Characterize Incident

Organism Common Food Vehicle Reservoirs Biocides (Sanitizers)*

Foodborne/Waterborne Gram positive pathogenic bacteria

Listeria monocytogenes Milk, raw vegetables and Bird, mammals Quaternary ammonium ice cream (including humans), soil, compounds (QAC) are water, and feces effective, less effected RTE items as smoked by residual soil than fish, prepared salads, chlorine compounds and cheese, sprouts, cooked leave an antimicrobial meat, poultry, and film after use. Chlorine delicatessen meats. compounds, iodophors, ozone, hydrogen peroxide and peracetic acid are also used.

Staphylococcus aureus Poultry, meat and egg Humans and animals See Above products (primary sources), dust, air, water, sewage, Delicatessen salads and equipment and surfaces sandwiches (egg, tuna, macaroni, etc.), cream filled bakery items (éclairs, cream pies, etc.) and dairy products.

Foodborne/Waterborne parasites

Cryptosporidium, Produce; raspberries Livestock, wildlife, Resistant to bleach, Cyclospora, Giardia and and other berries, and humans (except peracetic acid, Toxoplasma lettuce, fresh herbs; Toxoplasma), water and phenols, and QAC (Entamoeba: Common unpasteurized fruit soil. at commercially in tropical and sub- juices and milk. recommended tropical regions) Toxoplasma may also concentrations. Also contaminate the meat of resistant to chlorinated livestock, mainly pork water. Ozone and hydrogen peroxide are considered to be the most effective water disinfecting agents. Chlorine dioxide is also used. Liquid hydrogen peroxide (6.0 - 7.5%) is an effective surface sanitizer. Ozone and hydrogen peroxide are safe for use in foods according to 21 CFR 173. UV radiation may be used against Cryptosporidium in water supplies

*Effectiveness of any sanitizer is dependent on the type of surface being sanitized, temperature, humidity, and pH. 7 DRAFT GUIDANCE Characterize Incident

Organism Common Food Vehicle Reservoirs Biocides (Sanitizers)*

Foodborne/Waterborne Sporeforming bacteria

Bacillus Meats, milk, fish, vegetables, Soil, sediments, Quaternary ammonium compounds cereus and rice RTE foods such as vegetation, insects generally not effective against sauces, puddings, gravies, and animals, and spores. Bleach and hydrogen pasta, salads, soups, and cereal grains peroxide, peracetic acid casseroles chlorine dioxide and ozone are effective against spores at high concentrations (EPA).

Clostridium fish, poultry, soups, gravies, Humans, animals See Above perfringens meat roasts, stews, and dried and insects soil, soups/gravy mixes water sediments, compost, and decaying vegetation

Clostridium Canned vegetables and meat soil and sediments See Above botulinum products and seafood

Foodborne/Waterborne viruses

Norovirus Fruits and vegetables Human Hydrogen peroxide, ozone, bleach, contamination, RTE foods chlorine dioxide, and some (preparation by an infected quaternary ammonium compounds food handler) or shellfish are considered effective against contaminate through infected Norovirus and Hepatitis. Higher water) concentrations of active compound (compared to bacteria) may be required.

Hepatitis A Ice, water, fruits, vegetables, Human See Above shellfish, and take-out foods

*Effectiveness of any sanitizer is dependent on the type of surface being sanitized, temperature, humidity, and pH.

References and Acknowledgements FDA Bad Bug Book. http://www.fda.gov/Food/FoodSafety/FoodborneIllness/

Contact Dr. Cosby at 919-733-7366 ([email protected]) for more information

8 DRAFT GUIDANCE INNOVATIVE FOOD DEFENSE PROGRAM 4

The Sanitation Process, Ingredients, and Storage

Introduction • Forklifts, hand trucks, trolleys and racks • Trash cans If a food processing plant and some or all of the • Pallets for ingredients and product refrigerated or frozen ready-to-eat (RTE) foods produced has been contaminated with microbial Utilities adulterants, careful steps must be taken to rid the plant of these adulterants and help prevent • Compressed air systems including air their recurrence. This document is provided in a filters series to address recommendations on controls • Ice makers to reduce the potential of contamination of RTE • Refrigeration systems including freezers foods. The topics addressed include: • Personnel • The design, construction and operation of Common Situations that have resulted in your plant Contamination of RTE Foods • The design, construction and maintenance There are a number of scenarios that have been of equipment, and identified as having contributed to the microbial • Sanitation Controls contamination of RTE Foods. These include but This specific document is provided to give are not limited to the following: recommendations regarding The Sanitation Process for the clean-up and control of microbial • Used equipment is brought from storage contamination in a RTE food plant. Potential and installed in the process line without sources of contamination in RTE foods can include through cleaning but are not limited to: • A new employee who is not properly Food Contact Surfaces trained is delegated to help clean process equipment • Fibrous and porous-type conveyor belts • Filling and packaging equipment • Raw or under-processed food is brought • Belts, peelers and collators into the area where cooked food is held • Containers, bins, tubs, baskets • Maintenance workers move from raw • Slicers, dicers, shredders and blenders areas to packaging machines without • Utensils changing clothes or properly washing their • Gloves hands Non-contact Surfaces • Heat exchangers become compromised • In-floor weighing equipment (have pinhole leaks) • Cracked hoses • Equipment parts, food bins, tubs, etc. are • Hollow rollers for conveyances cleaned on the floor • Equipment framework • Open bearings • Improper use of footbaths • Motor housings • Employees arrive for work in dirty clothes • Maintenance tools (screwdrivers, or boots and are not provided with a wrenches) change • On/Off switches • Cleaning tools (brushes, brooms, scrapers) • Condensate drip pans DRAFT GUIDANCE The Sanitation Process, Ingredients and Storage

Who Should Follow The Guidance in this the isolation step, plans should be developed to Document? assure that positive air pressure is maintained in the RTE areas. The positive pressure should be We would recommend that any processor of RTE maintained with a HEPA filtered air supply. foods would benefit by following the guidance provided by this document and other documents Sections of the GMPs (21 CFR part 110) that in this series. The guidance is especially must be considered in all decisions regarding formulated for those processors who have had sanitation for plants producing RTE foods include products recalled or their facility closed due to but may not be limited to the following: microbially contaminated foods either by the FDA 110.35 (a), 110.35 (d) (1), 110.80 (b) (1), 110.80 (b) (7) or the NCDA&CS. However, we believe that all RTE foods processors will benefit from following The following specific steps provide specific these recommendations to help avoid the product guidance for the areas and operations listed: contamination/plant closure scenario.

How Does this Document Relate to the FDA GMPs Design and Construction of Sanitary and Other Regulations? Equipment: We recommend you obtain and study Sanitary Equipment Design which This document is not meant to provide any is a companion document in this series to Guidance which contradicts FDA’s GMPs. If understand how to properly clean each piece one studies the GMPs, you find that binding of equipment equipment. We recommend requirements for the processing of food are given you obtain and study the modules entitled as shall while the non-binding recommendations cleaners and sanitizers which are companion are given as should. The guidance and documents in this series to fully understand recommendations in this document are meant to how each impacts the sanitation process. complement those of the GMPs. Other regulations must be followed such as milk products producers Equipment: We recommend you obtain and must follow the Grade A Pasteurized Milk study Sanitary Equipment Design which is a Ordinance and shellfish products producers must companion document in this series. follow the National Shellfish Sanitation Program Model Ordinance. Equipment for Transport: Carts, forklifts, Understanding Your Ingredients, Process, Cleaners mobile racks and pallets are known sources of potential contamination. Therefore, we and Sanitizers and Finished RTE Product recommend that you designate one set of One must understand their intended RTE such equipment to areas where RTE foods food product thoroughly to determine the best are prepared and processed (exposed). We ingredients, process, packaging and necessary recommend that you clean and sanitize the cleaning and sanitation processes. This document wheels of all transport devices before they especially addresses the needs of sanitizers and enter areas where RTE foods are processed provides recommendations and guidance to help or exposed. We recommend that you use a provide the framework for controlling microbial mechanism such as color coding to distinguish contamination of RTE foods. between transport items used in RTE foods preparation and exposure areas and those The Sanitation Process for RTE Food Plants where raw materials are handled or stored. General Considerations: We would recommend Water Systems: We recommend that water that you separate RTE food production areas systems be properly designed, installed and from raw food areas. In general, the areas maintained such that backflow and cross- where RTE foods are prepared, processed and connections between potable and non-potable stored before they are finished RTE foods should water lines and systems are not allowed. We be isolated as much as possible to reduce the recommend that you have mixed hot and cold potential for contamination of RTE foods via air, water at all hand washing stations. Also, that aerosols or traffic of employees, equipment and all water treatment systems be maintained and supplies. Equipment washing areas should be periodically inspected such that they do not isolated. Cleaning with high pressure systems become a source of microbial contamination. should only take place in such a manner that exposed food and food contact surfaces are not subject to overspray and aerosols. In addition to 2 DRAFT GUIDANCE The Sanitation Process, Ingredients and Storage

Personnel: We recommend you obtain floor and study Personnel Sanitation which is a • Rinse floors with low pressure/low volume companion document in this series. water • Sanitize floors with appropriate chemical Sanitation: High pressure water hoses should sanitizer not be used while RTE foods are exposed or • Remove excess water if needed after equipment has been sanitized for use. This helps prevent aerosols from contacting We recommend for clean-in place (CIP) systems RTE foods, food contact surfaces, food that the following be monitored: packaging materials and personnel handling • Concentration of cleaner solution and these foods. We recommend you obtain and sanitizers study Sanitation and Cleaners and Sanitizers • Verify flow rate which are companion document in this series. • Time • Temperature General Sanitation Program We recommend for wet cleaning of equipment: We would recommend that a sanitation standard • Do not use this procedure in a room operating procedure (SSOP) and sanitation where RTE food is exposed, even if food is maintenance schedule be developed where RTE covered foods or food contact surfaces are processed or • Remove all exposed RTE food before any exposed. We recommend that these SSOPs for wet cleaning of floors and equipment food cleaning equipment and floors identify: • Remove all exposed RTE food from cooler before cleaning cooler, refrigeration • Equipment or area to be cleaned condenser units, or condensate drip pans • Disassembly of equipment, if necessary and hoses • Frequency of cleaning • Type and concentration of cleaning We recommend for CIP systems: materials and sanitizers • Have separate systems for cleaning • Time/temperature of cleaning solutions equipment used to process RTE food and • Flow rate (velocity) or pressure if CIP used that used to process raw food • If you use a common system , maintain We recommend that SSOPs for cleaning and temperature alkaline cleaning solution at sanitizing equipment include the following: or above 71OC (160OF) • Lock out/Tag out-designated personnel • Use separate COP system for used for power down and secure equipment to cleaning processing equipment for prevent inadvertent start up RTE food and for equipment used for • Dry clean/ solids removal including processing raw food packaging material We recommend that you maintain and clean • Pre-rinse equipment to remove visible food equipment used for cleaning to prevent it from soil (correct temperature) becoming a source of contamination and use • Apply cleaner ( correct type, concentration, a color coding system for RTE and raw product temperature) cleaning. Sections of 21 CFR part 110 that are • Scrub or circulate applicable to a general sanitation program • Rinse to remove cleaner and food residue include: • Sanitize- apply heat or sanitizer (correct temperature, correct time, correct 110.35(a), 110.35(d)(1), 110.80(b)(1), 110.80(b)(7). concentration We recommend for cleaning floor drains to • Verify proper cleaning and sanitizing prevent contamination of other surfaces : We recommend that SSOPs for cleaning and • Do not clean floor drains when RTE foods sanitizing floors include: are processed or exposed • Removal of heavy soil or debris from floors • Do not use high pressure hoses to clear • Clean other debris including packaging or clean a drain, since it could create material from floors aerosols and spread contamination • Rinse floors with low pressure/low volume • Brushes used to clean floor drains may water at correct temperature be at least ¼” (0.64 cm) smaller than the • Use a brush (colored coded) for floor use diameter of the drain opening to reduce only or floor scrubber and cleaner to scrub aerosols from brushing

3 DRAFT GUIDANCE The Sanitation Process, Ingredients and Storage

• Use a splashguard to prevent splashing If a COC is used, it is recommended that an during cleaning annual on-site audit of the supplier be conducted • Utensils used for drain cleaning be and the processor periodically tests ingredients dedicated to that purpose and easily to verify absence of pathogens. If a COA is used, identified (color coded) the sampling plan, analytical method, and limits of the method should be indicated. Results of the We recommend when a drain backs up and water COA should be verified by testing on a periodic flows into an area where RTE foods are being basis. processed: Sections of the GMPs (21 CFR part 110) that • Stop production must be considered in all decisions regarding • Remove any uncovered RTE foods from ingredients for plants producing RTE foods affected area include but not limited to the following: • Clear the drain • Clean the affected area with an effective 110.80, 110.80(2), and 110.80(b)(4) cleaner, rinse the drain, sanitize it and remove excess water Storage Practices • Following drain cleaning employees should change clothes, wash and sanitize hands Microbial growth is very dependent on time and before any contact with RTE food contact temperature since most pathogens normally have surfaces an optimum growth temperature of human body • If bactericidal drain rings are used, monitor temperature (37oC, 98.6oF). It is estimated that and replace them when appropriate under ideal conditions some bacteria can double in numbers in approximately 15-20 minutes. It is Sections of 21 CFR part 110 that are applicable to very important to control both of these conditions. cleaning drains include: It is also important to prevent cross-contamination 110.10(b)(1), 110.10(b)(3), 110.35(a), 110.37(b)(3) by isolating raw and processed RTE foods. This involves separate storage areas for these Traffic Flow: To minimize the possibility of products. microbial contamination, we recommend that you control the traffic flow pattern for people, It is recommended that the processor implement food products and equipment. procedures to minimize the time that ingredients and other raw materials, in-process materials, Prevention of Contamination of Ingredients and and finished foods are stored. We recommend that Proper Storage the processor establish and follow procedures to use a first-in first-out (FIFO) system. Ingredients: Ingredients may be contaminated with disease causing microorganisms It is recommended that the processor transport (pathogens) and it is recommended that the and store ingredients and other raw materials, processor treat ingredients with a control in-process materials, and finished foods at an internal temperature of less than or equal to 4oC measure such as heating (cooking) to control o contamination. Alternatively, there are many ( 40 F) and the processor establish and use control EPA and FDA certified antimicrobial agents measures to achieve required temperature. available that can be used as direct food Keep in mind, Listeria monocytogenes, a potent contact sanitizers to treat raw agricultural bacterial pathogen in RTE foods can grow at products, raw poultry, beef and seafood (see refrigerated temperatures. Table 2 in the Sanitizers and Decontamination It is recommended that during process, the Module) If these control measures are not used, processor establish and use controls on the it is recommended that controls be established amount of time that ingredients and other raw and implemented to reduce the potential for materials, in-process materials are held above pathogens. These suggested controls include: 4oC ( 40oF). • Obtain ingredients using a supplier’s Sections of the GMPs (21 CFR part 110) that must Certificate of Conformance (COC) be considered in all decisions regarding storage (guarantee) for plants producing RTE foods include but not • Obtain ingredients using a supplier’s limited to the following: Certificate of Analysis (COA) • Test ingredients or other raw materials for 110.40(c), 110.80(a)(5), 110.80(b)(2), 110.80(b)(3) pathogen presence and 110.80(b)(3) 4 DRAFT GUIDANCE The Sanitation Process, Ingredients and Storage

Definitions FDA refers to the U.S. Food and Drug Administration. Adulterated food defined by FDA, if food bears or contains poisonous or deleterious (harmful) Good Manufacturing Practices (GMPs) refers substance, contains filthy, putrid, decomposed to all practices used in the food facility to make substance or any substance that is unfit for sure food products are produced under safe human food. The food is prepared, packed, and sanitary conditions and protected from or held in a manner that may cause it to be adulteration. Code of Federal Regulations contaminated or injurious to health. (CFR), Title 21, Part 110.

Certificate of Analysis (COA) is a document NCDA&CS refers to the N.C. Department of that reports and certifies the test results of a Agriculture and Consumer Services. product. We recommend that you also familiarize yourself Certificate of Conformance (COC) is a with the definitions found in 21 CFR 110.3 which document confirming that a product or service you can access on FDA’s internet website for meets the required specifications, regulations Center for Food Safety and Applied Nutrition or contractual agreements. (CFSAN).

Clean in place (CIP) means a system to clean Sanitation refers to all precautions and piping or equipment without disassembly, measures which are necessary in the where interior product zones are fully exposed production, processing, storage and distribution and soil can be washed away with a cleaning in order to assure an unobjectionable, sound solution and then sanitized with a properly and palatable product which is fit for human diluted sanitizer. consumption.

Clean out of place (COP) means a system used Sanitation Training refers to a comprehensive to clean parts and pieces after disassembly. training program including the fundamentals of cleaning and sanitation to provide a high Critical food-contact surface means a surface degree of safety for consumers, employees, that contacts food, or a surface from which and the environment. drainage onto the food or onto surfaces that contact the food in the ordinary process when SSOP refers to sanitation standard operating the food is not being subjected to an approved procedure, defines a procedure for cleaning control process. and sanitizing equipment or areas in a food processing facility. Critical non-food contact surface or area means a surface (other than food contact) that could, through action of man or equipment References and Acknowledgments contaminate a food that will thereafter not be Substantial portions of this document were subjected to the approved control process. suggested or directly obtained from FDA Draft Guidance Document: Control of Listeria Cross-contamination microorganisms or toxic monocytogenes in Refrigerated or Frozen Ready- chemicals are transferred to the food product to-Eat Foods. Feb. 2008. from food handlers, raw food products or the environment. Basic Elements of Equipment Cleaning and Sanitizing in Food Processing and Handling Finished RF-RTE Food means a refrigerated or Operations. R.H. Schmidt. Univ. of Florida IFAS frozen RTE Food that has been processed by Extension FS14; 1997, revised 2009, Reviewed an approved process and is packaged. 2012

Ready-to-Eat (RTE) Food means a food that is Food Equipment Cleaning and Sanitizing: Water customarily consumed without cooking by the Chemistry and Quality, Sanitizer Properties. consumer or that appears to be suitable for Arizona Department of Health Services, Food use without cooking. Safety and Environmental Services. 2012 Making The Right Choice-The Sanitation Process. R.Bakka, Editor. Ecolab Inc. 1997

5 DRAFT GUIDANCE The Sanitation Process, Ingredients and Storage

Notes

6 DRAFT GUIDANCE The Sanitation Process, Ingredients and Storage

Notes

7 DRAFT GUIDANCE The Sanitation Process, Ingredients and Storage

Notes

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8 DRAFT GUIDANCE 5 INNOVATIVE FOOD DEFENSE PROGRAM

Sanitary Personnel Practices for RTE Food Plants

Introduction Common Situations that have resulted in If a food processing plant and some or all of the Contamination of RTE Foods refrigerated or frozen ready-to-eat (RTE) foods There are a number of scenarios that have been produced has been contaminated with microbial identified as having contributed to the microbial adulterants, careful steps must be taken to rid contamination of RTE foods. These include but the plant of these adulterants and help prevent are not limited to the following: their recurrence. This document is provided in a series to address recommendations on controls • Used equipment is brought from storage to reduce the potential of contamination of RTE and installed in the process line without foods. The topics addressed include: through cleaning • Personnel • A new employee who is not properly • The design, construction and operation of trained is delegated to help clean process your plant equipment • The design, construction and maintenance • Raw or under-processed food is brought of equipment, and into the area where cooked food is held • Sanitation Controls • Maintenance workers move from raw This specific document is provided to give areas to packaging machines without recommendations regarding personnel practices changing clothes or properly washing their and specifically addresses guidelines to help hands prevent contamination by microbial organisms. Potential sources of contamination in RTE Foods • Equipment parts, food bins, tubs, etc. are can include but are not limited to: cleaned on the floor Food Contact Surfaces • Improper use of footbaths • Fibrous and porous-type conveyor belts • Employees arrive for work in dirty clothes • Utensils or boots and are not provided with a • Gloves change Non-Contact Surfaces Who Should Follow The Guidance in this • Employee clothing • Cracked hoses Document? • Maintenance tools (screwdrivers, We would recommend that any processor of RTE wrenches) foods would benefit by following the guidance • On/Off switches provided by this document and other documents • Control panels in this series. The guidance is especially • Cleaning tools (brushes, brooms, scrapers) formulated for those processors who have had • Forklifts, hand trucks, trolleys and racks products recalled or their facility closed due to • Trash cans microbially contaminated foods either by the FDA • Pallets for ingredients and product or the NCDA&CS. However, we believe that all RTE foods processors will benefit from following Utilities these recommendations to help avoid the product • Ice makers contamination/plant closure scenario. • Refrigeration systems including freezers • Employees are often common denominators DRAFT GUIDANCE Sanitary Personnel Practices for RTE Food Plants

How Does this Document Relate to the FDA vestibule should be established where GMPs and Other Regulations? protective clothing is donned (put on) and hands are washed and sanitized. This document is not meant to provide any Guidance which contradicts FDA’s GMPs. If • Employees in raw ingredients areas are one studies the GMPs, you find that binding prohibited from entering production areas requirements for the processing of food are given • Employees who handle food should not be as shall while the non-binding recommendations allowed to pick up items from the floor are given as should. The guidance and recommendations in this document are meant to • We recommend that employees in compliment those of the GMPs. Other regulations production area who handle trash, floor must be followed such as milk products producers sweepings, and waste pick up these items must follow the Grade A Pasteurized Milk as necessary. Ordinance and shellfish products producers must • All brooms, squeegees, dust pans and follow the National Shellfish Sanitation Program other cleaning items should be color Model Ordinance. coded and dedicated to a specific area of Understanding Your Ingredients, Process, the facility. For example, blue brooms are Personnel and Finished RTE Products dedicated to the production area and used there exclusively whereas red brooms are One must understand their intended RTE only used in raw ingredient area. food product thoroughly to determine the best ingredients, process and packaging and how your • Normal maintenance tools, step stools, employees contribute to each. This document ladders, and trash bins should be color especially addresses personnel issues and coded and dedicated to a specific work provides recommendations and guidance to help area provide the framework for control of microbial • Forklifts, hand trucks, pallet jacks and contamination of RTE Foods. other wheeled equipment used in raw ingredient or dock areas should not be Sanitation for Personnel and Contractors allowed in production areas

General Considerations: We would recommend that Clothing: We recommend the following: you separate and segregate employees from RTE food production areas from those that work in raw • Employees not wear street clothes in areas food areas. In general, the areas where RTE foods where RTE foods are prepared or exposed are prepared, processed, and packed before unless the street clothes are adequately shipment should be isolated as much as possible covered above the knees with a clean to reduce the potential for contamination of RTE smock or coat. foods via air, aerosols or traffic of employees and their personal gear. • Provided smocks and coats should not be worn outside the production area except Sections of the GMPs (21 CFR part 110) that must in an adjacent vestibule where they are be considered in all decisions regarding plants donned such as the hand wash area. producing RTE Foods include but may not be limited to the following: • Smocks and coats are never worn in 110.10 (a) 110.10 (b) (1) bathrooms. 110.10 (b) (3) 110.10 (b) (5) • Smocks or uniforms for RTE food 110.0 (b) (9) 110.10 (c) preparation areas should be color coded 110.37 (f) such that they are easily distinguishable

The following specific steps provide specific from others. Production and sanitation guidance for the areas and operations listed: functions should be color coordinated to prevent any confusion between employees. Cross contamination Prevention: Further, employees working with raw materials should have different color • Production areas are considered critical garments than those with finished RTE control points or Primary Pathogen Control Foods. Areas (PPCA). Movement in and out of these areas should be limited to authorized • Contact of food with bare hands is not personnel. In addition, a buffer area or allowed. All employees who come in 2 DRAFT GUIDANCE Sanitary Personnel Practices for RTE Food Plants

contact with food must wear gloves and exposed should thoroughly wash their hands and replace them as necessary. dry them according to sanitary SOP established by the facility. Hand sanitizer should be used after • If employee(s) arrive with dirty clothes and washing. NOTE: hand sanitizers do not replace shoes/boots (i.e arriving from a farm with thorough hand washing. Hands free sinks and manure showing), the employee should hands free soap and towel dispensers should be be or be given access to a shower and a installed at all hand wash stations. complete change of clothing or sent home to change. We recommend the use of suitable utensils (tongs, spatulas) or gloves when touching RTE foods, Health and Hygienic Practices: Training the food contact surfaces and packaging materials. work force is vital is reduce the risk of product In other words, bare hands should never perform contamination. The concept of critical control such tasks! In regard to glove use, we recommend points and primary pathogen control areas (PPCA) that: must be explained so workers truly understand these concepts. A clear understanding of these • Employees wash and sanitize their hands concepts will increase employee compliance to the before putting gloves on. sanitary SOP. All employees, outside contractors and seasonal or temporary workers must receive • Rubber or plastic work gloves be washed this training. A bi-annual or annual update and and sanitized before use. review should be held for all employees. • Single use gloves be discarded and Worker Illness: We recommend that any employee replaced after an employee touches a non- or contractor suffering from gastroenteritis, the food contact surface or material. flu or colds be excluded from working in food • Gloves worn outside areas where RTE production areas. Further, any open cuts or sores foods are prepared or exposed be must be adequately covered before entry to the discarded before returning to the food production area. production area. Proper hand washing Hair and Beard Nets: We recommend that all sanitary SOP must be followed each time a employees wear hair and beard nets for any facial person enters the production area hair, including moustaches. Employees wearing • Hand sanitizers do not take the place of hard hats should wear hair nets underneath the proper hand washing hat as hair is exposed. Personal baseball and snap-back type caps worn outside the facility Reusable gloves have proven hard to clean and should not be worn in the production area. sanitize properly to avoid microbial contamination. We recommend their use only when handling Arm and Chest Hair: We would recommend that meat items with bones or other items that tend to any excessive arm or chest hair be covered either puncture gloves with less thickness. If reusable by a coat or other device such as arm guards gloves are found desirable, we recommend that (disposable sleeves). a very detailed procedure be developed to assure Jewelry and Personal Effects: Rings, ear rings, that cleaning and sanitation really occurs after necklaces, false fingernails and nail polish cannot each use. Employees should be reminded that be worn in the production area and pens or other careful hand washing and sanitation is still a items cannot be carried in the breast pocket of precursor to reusable glove use. shirts, male or female. This applies to employees, We recommend that employees be taught contractors and regulatory officials. A good rule and that supervisors monitor practices that lead of thumb is; no jewelry or other items above the to glove puncture and subsequent failure. Some waist. Note that some facilities may restrict the of these include long and poorly maintained use of perfume. Ties should not be worn into RTE fingernails, rings, false fingernails, wrist jewelry areas even when partially covered by a smock or including watches and careless handling of jacket. equipment. Environmental conditions will also influence Hands, Hand washing and Gloves: Hand washing glove wear. For example, hot working conditions may be the most critical link to reducing the risk of will cause the hands to sweat in the gloves which RTE-food contamination. Norovirus and Hepatitis can actually loosen bacteria from the skin and A are common organisms transferred to food by under fingernails. Also, employees are more likely food handlers. Any employee or contractor who to wipe exposed areas of their skin with the back enters an area where RTE foods are prepared or of their gloved hands introducing contamination. 3 DRAFT GUIDANCE Sanitary Personnel Practices for RTE Food Plants

Employees should wash hands and change debris. They also must be periodically cleaned at gloves more frequently under these conditions. least during every break. This will help minimize Proper glove use should be taught and periodically slips and falls even with non-skid soles on the reviewed. Employees should understand that boots of employees. as soon as they detect a failure in a glove, the glove should be discarded properly, the hands Definitions washed and sanitized and a replacement put Critical Control Point – steps in the production on each hand. The high prevalence of biological process that are most important in reducing the contaminants such as Norovirus necessitate the risk of contamination proper use of gloves even in RTE food plants that have traditionally been considered low risk types Critical food-contact surface means a surface that of foods. contacts food, or a surface from which drainage Gloves should be changed as often as onto the food or onto surfaces that contact the needed in an RTE facility. This should at least food in the ordinary process when the food is not include changes at every break, at least every being subjected to an approved control process. two hours or when gloves are punctured or Critical non-food contact surface or area means contaminated. a surface (other than food contact) that could, Boots: We recommend that employees and through action of man or equipment contaminate contractors who enter areas where RTE foods a food that will thereafter not be subjected to the are prepared or exposed should wear footwear approved control process. that is only worn in that area. Further, it should be Donned – To put clothing on made of an impenetrable material that is in good repair and can be easily cleaned and sanitized. PPCA – Primary Pathogen Control Area; area We recommend footbaths with sanitizer when where the presence of a pathogen presents entering areas where RTE foods are prepared the highest risk of food contamination, such as or exposed. They must be checked frequently to production and packaging areas. assure proper sanitizer levels. In dry areas, we do not recommend wet footbaths and believe that We recommend that you also familiarize yourself dry powdered sanitizer may be more appropriate. with the definitions found in 21 CFR 110.3 which you can access on FDA’s internet website for Maintenance Employees: All maintenance employees Center for Food Safety and Applied Nutrition and contractors should follow the same requirements (CFSAN). of sanitary SOP for production employees. References and Acknowledgements Sanitation: We recommend you obtain and study Sanitation and Cleaners and Sanitizers which are Substantial portions of this document were companion document in this series. suggested or directly obtained from FDA Draft Guidance Document: Control of Listeria Traffic Flow: To minimize the possibility of microbial monocytogenes in Refrigerated or Frozen Ready- contamination, we recommend that you control to-Eat Foods. Feb. 2008 the traffic flow pattern for people, food products and equipment. Green, L.R., et al. 2007. Factors Related to Food Worker Hand Hygiene Practices. J Food Protect. Floor Cleaning and Maintenance: The floors in all wet 70(3):661-666. areas must be kept reasonably clean and free of

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4 DRAFT GUIDANCE INNOVATIVE FOOD DEFENSE PROGRAM 6

Cleaners for RTE Food Plants

Introduction • Motor housings on equipment • Maintenance tools (screwdrivers, Once a contamination event in refrigerated wrenches) or frozen ready-to-eat (RTE) product has been • On/Off switches identified, the source of that contamination • Equipment control panels must be identified. If the contaminant is traced • Cleaning tools (brushes, brooms, scrapers) to the facility, careful steps must be taken to rid • Condensate drip pans the plant of these adulterants and help prevent • Forklifts, hand trucks, trolleys and racks their recurrence. These documents are provided • Trash cans as recommendations for activities and controls • Pallets for ingredients and product to recover from and reduce the potential for recurrent contamination of RTE foods. The topics Utilities addressed include: • Electrical cords and plugs • Water hoses and nozzles • Personnel • Compressed air systems including air • The design, construction and operation of filters your plant • Ice makers • The design, construction and maintenance • Refrigeration systems including freezers of equipment • Fans and other air handling equipment • Sanitation Controls This specific document is provided to give Common Situations that have resulted in suggestions for cleaning in response to microbial Contamination of RTE Foods contamination of a RTE food plant. Refer to There are a number of scenarios that have been the definitions at the end of this document for identified as having contributed to the microbial clarification of the terms involved. contamination of RTE foods. These include but Potential sources of contamination in RTE foods are not limited to the following: can include but are not limited to: • Used equipment is brought from storage Food Contact Surfaces and installed in the process line without • Fibrous and porous-type conveyor belts thorough cleaning • Filling and packaging equipment • A new employee who is not properly • Work Tables trained is delegated to help clean process • Belts, peelers and collators equipment • Containers, bins, tubs, baskets • Raw or under-processed food is brought • Slicers, dicers, shredders and blenders into the area where cooked food is held • Utensils • Maintenance workers move from raw • Gloves areas to finished product areas without changing clothes or properly washing their Non-contact Surfaces hands • Floors and walls • Water from a roof leak in a warehouse • Sinks, faucets, and water fountains area contaminates the packaging of • In-floor weighing equipment product constituents which are handled by • Air and water hoses process personnel in production area • Hollow rollers for conveyances • Heat exchangers become compromised • Equipment framework (have pinhole leaks) • Open bearings DRAFT GUIDANCE Cleaners for RTE Food Plants

• Equipment parts, food bins, tubs, etc. are Cleaners for RTE Food Plants cleaned on the floor • Improper use of footbaths General Considerations: We would recommend that • Employees arrive for work in contaminated you separate RTE food production areas from clothes or boots and are not provided with raw food areas. In general, the areas where RTE a change foods are prepared, processed and stored before • Standing water on floor they are finished RTE foods should be isolated as much as possible to reduce the potential for Who Should Follow The Guidance in this contamination via air, aerosols, employee traffic, Document? equipment and supplies. Equipment washing areas should be isolated. Cleaning with high Any processor of RTE foods would benefit by pressure systems should only take place in such following the guidance provided by this document a manner that exposed food and food contact and other documents in this series. The guidance surfaces are not subject to overspray and aerosols. is especially formulated for those processors who In addition to the isolation step, plans should be have had products recalled or their facility closed developed to assure that positive air pressure due to microbially contaminated foods either by is maintained in the RTE production areas. The the FDA or the NCDA&CS. However, we believe positive pressure should be maintained with a that all RTE foods processors will benefit from High Efficiency Particle Attenuation (HEPA) filtered following these recommendations to help recover air supply. from or avoid the product contamination/plant closure scenario. Sections of the GMPs (21 CFR part 110) that must be considered in all decisions regarding How Does this Document Relate to the FDA sanitation for plants producing RTE foods include GMPs and Other Regulations? but not limited to the following:

This document is not meant to provide any 110.35(a),110.35(d)(1), 110.80(b)(1), and 110.80(b)(7) Guidance which contradicts FDA’s GMPs. If one studies the GMPs, you find that binding Cleaning requirements for the processing of food are given The process which removes soils that may as shall while the non-binding recommendations support the growth of microorganisms or inhibit are given as should. The guidance and the sanitizing of a surface. The surface must be recommendations in this document are meant to thoroughly cleaned and rinsed before it can be compliment those of the GMPs. Other regulations sanitized or decontaminated. Cleaning can be must be followed such as milk products producers accomplished by manual (bucket and brush) or must follow the Grade A Pasteurized Milk mechanical processes. Ordinance and shellfish products producers must follow the National Shellfish Sanitation Program Employee safety is of utmost importance in Model Ordinance. preparing and using cleaners. The cleaner should always be added to the water (not vice versa) in Understanding Your Ingredients, Process, preparation to prevent reaction and splashing of Cleaners, and Finished RTE Product; the mixture. Employees should be provided with Cleaners and Sanitizers personal protective equipment (PPE) including a face shield, gloves, and protective aprons or One must understand their intended RTE impervious coveralls and protective footwear food product thoroughly to determine the best when preparing and using cleaning solutions. ingredients, processes, packaging and cleaning Employees should familiarize themselves with and sanitation processes. In addition, when the Material Safety Data Sheets (MSDS) for all dealing with or recovering from a contamination chemicals. This is basic information related to incident it is important to select the proper cleaners and safety requirements for chemical cleaning, sanitizing, and decontamination agents use including storage and preparation. MSDS and procedures. This document especially must be maintained on file and available to all addresses the needs of cleaners and provides employees. recommendations and guidance to help provide the framework for controlling microbial Factors that Affect Cleaning contamination of RTE foods and food processing • Is the surface to be cleaned easily facilities. accessible; under or inside the equipment; in a closed system or pipe line? 2 DRAFT GUIDANCE Cleaners for RTE Food Plants

• Is it a vertical part of the equipment where Cleaning Methods foams or gels are required to remain in • Wet Cleaning contact. • Manual • Is it overhead? • Automatic (e.g., automated rack and pan washers) Functions of Cleaners • Soaking Cleaning agents are designed to assist the • Spraying cleaning process with the following procedures: • Clean-in-place (CIP) • Defloculation or dispersion – breaks up • Clean-out-of-place (COP) particles and suspends them in solution • Foaming • Dissolves and solubilizes the soil • Gelling • Emulsification breaks up fats and • Abrasive cleaning suspends them in the cleaning solution • Dry cleaning • Penetration is entering the soil through pores Types of Soils • Peptization- breaks up proteins to form colloids Visible food soil classes include fats, proteins, • Saponification - forms soaps from fats carbohydrates and mineral salts. Invisible soils • Suspension keeps insoluble particles in include microorganisms (bacteria, yeasts, molds, solution and prevents accumulation on viruses). surfaces Fats or Oil Soils • Rinsability breaks surface tension and Fats or oils exist in food products as an allows drainage emulsion and are not water soluble. They can • Wetting increases contact with soil, be removed by raising the temperature using reduces surface tension, increases hot water and changing the fat to a liquid, this emulsification can cause problems by solidifying in the drains. • Synergists- increase total detergency Alkaline detergents with ingredients to break Cleaning Compounds are composed of the up the fat (emulsify) or change it to a soap (saponify) can be used for more demanding following materials: fat/oil residues. • Alkali – emulsify and saponify fats and oils and peptize proteins Protein Soils • Phosphates – emulsify, peptize, disperse, Protein soils may present special problems soften water and prevent accumulation on in cleaning if they have been denatured surfaces by heating or by being exposed to an acid • Surfactants – wet and disperse soils, environment. The proteins may also combine allow water and the cleaning compound with mineral salts following heating to result in to penetrate the soil for removal from the a stone formation. The cleaning procedures for surface removing protein soil include alkaline or acid • Chelating agents – soften water and cleaners, an oxidizing material, or an enzyme. control mineral deposits, displaces soil and Protein soils that are not denatured can be prevents accumulation on surfaces. removed by a water rinse. Strong alkali can be • Acids – prevent and remove mineral used to remove denatured proteins and can deposits, they also will remove the ”stone” also be combined with an oxidizing agent such which is a combination of denatured as chlorine. These are known as chlorinated proteins and minerals alkaline cleaners. Acid cleaners are effective • Enzymes--used to break down larger soil in removing denatured protein and mineral units to smaller units, examples include: combinations described as “stone”. Enzymes lipases (fats or oils), amylases (starches), are organic materials which break down and proteases (protein). These materials (hydrolyzes) proteins to smaller particles. are temperature sensitive and the Enzymes are proteins and function in a narrow maximum temperature for their use should pH and temperature range. be 120°F. Carbohydrate Soils • Chlorinated Alkali remove protein soils Carbohydrates (sugars) normally do not present a problem in cleaning and can be removed with water and an alkaline cleaner. 3 DRAFT GUIDANCE Cleaners for RTE Food Plants

Starch when heated gelatinizes and forms a gel, which can more effectively be removed • Nature of soil and amount present with an acid cleaner. The enzyme amylase can The soil to be removed is composed break down starch to more simple materials for of the food product residue and easier cleaning. The same restrictions apply to the possible minerals from the enzyme break down of proteins. water and cleaner mixture. Food products are composed of fats or Mineral Salts Soils oils, carbohydrates (simple- sugars) Mineral salts present problems with and complex (starches and fiber – interference in the cleaning and may decrease cellulose); proteins, and minerals. It is the effectiveness of cleaners. The mineral important to consider the effect of very salts may originate from water or the food soil. hot water in the rinse step on proteins. Calcium, magnesium, iron and manganese are • Choice of Cleaners some common minerals that cause salt films. The choice of cleaners is determined They may combine with protein to form “stone” by the food soil present and the ability and can be removed by acid cleaners (organic to prevent it from accumulating on the acids). The mineral salts from the water can be surface being cleaned. Sugars and bound (sequestered) to prevent the forming of minerals (salts) are soluble in water film on equipment surfaces. Polyphosphates, and can be removed by the rinse step. Chelating agents, and gluconates bind these Fats and oils are not soluble in water salts making them more solube and thus the (consider oil floating on a puddle). cleaner more effective. They can be solubilized by the use Potential Problem: Biofilms of an alkali (base) cleaner to form • Composed of a collection of bacteria soap. Proteins can be removed by a attached to surfaces and excreted chlorinated alkaline cleaner. Other extracellular polysaccharide or slime layer soils include lubricating grease and • Biofilms protect cells from adverse oils. environmental conditions and can be a Surface properties are also a primary source of intermittent contamination in the concern in the choice of cleaners. facility Stainless steel is generally preferred • Bacteria within biofilm may be up to 1,000X for surfaces and plastics (i.e., HDPE) more resistant to some sanitizers than cells can be used on conveyor belts and not in biofilm other moving parts. Aluminum is Method of cleaning and cleaner application subject to corrosion by both acids and alkalis and steel is subject to Manual cleaning can be used for small areas rust. Plastic and rubber are subject to or equipment that is disassembled. A cleaning cracking making them ideal surfaces solution and brush work well in cleaning areas for biofilm formation. Wood surfaces with a minimum amount of protein residue. It is should be avoided except for cutting recommended to have separate brushes for raw boards and tables. Any surface (unprocessed) food equipment and finished ready will corrode with exposure to harsh to eat product equipment. chemicals over time which can cause abrasions and pitting on surfaces. The contact time for the cleaner can be increased This reduces cleaning (and sanitizing) by the use of foams and gels. They work well in effectiveness and may dictate cleaning vertical surfaces and the concentration replacement of the surface. can be stronger than in a manual cleaner. The main types of mechanical cleaning methods Cleaning effectiveness include spray washers, clean-out of place (COP) Factors that affect cleaning effectiveness and Clean in Place (CIP). Automatic spray include: washers are similar to a car wash and materials move through on a conveyor system. A COP • Water Hardness and Treatment washer is a parts washer where equipment is Water hardness is the most important disassembled and placed in a vat where cleaning chemical property of water since it solution is circulated. A CIP system circulates a will influence cleaner effectiveness. rinse, wash, rinse and sanitizing cycle through It can impact the ability of a cleaning pipes and equipment. agent to effectively mix in solution or 4 DRAFT GUIDANCE Cleaners for RTE Food Plants

may result in an objectionable residual since it may have a negative impact on the on cleaned surfaces. There are two useful microorganisms involved in waste water types of water hardness, temporary treatment. Some publically owned treatment and permanent. Both types will result facilities limit pH discharges from processors to in a precipitation of minerals from a pH range of 5-8.5. The processor may change the water resulting in decreased the cleaner or adjust the pH of waste water before cleaner effectiveness and a deposit discharge. The phosphate content may also of scale on the surface cleaned. be restricted due to potential increase in algae Temporary hardness is due to calcium growth in surface waters. or magnesium bicarbonate and will precipitate by both heating and alkali High pressure water hoses should not be used (base). Permanent hardness is caused while RTE foods are present or after equipment by calcium or magnesium chlorides has been sanitized for use. This helps prevent or sulfates. Heating will not precipitate aerosols from contacting RTE foods, food contact the salts, but alkali (base) will cause a surfaces, food packaging materials and personnel precipitate. Several cleaners are alkali handling these foods. based and the cleaner effectiveness can be reduced. The hardness may Dry Cleaning Methods leave a scale or film. Water softener (absence or low amounts of water) systems may reduce or eliminate the problems related to this factor. • Dry Steam ( approximately 5% moisture) • Dry ice blasting • Cleaner Concentration • Vacuuming Normally higher concentrations increase effectiveness, however One dry cleaning alternative is superheated cleaners are expensive and employees saturated “dry” steam at 265°F at an adjustable should have sanitary SOP (Standard pressure of 0 to 150 psi that is created at Operating Procedures) for the temperatures far above the boiling point of water. preparation and use of cleaners. Superheated vapor combines the solvent power of water with high-temperature cleaning capability. • Temperature of Cleaning Solution The system will kill salmonella, E. coli, botulism and Surfaces and listeria contaminants. Dry steam can be used In normal practice cleaning rates on scales and sensors, conveyors, wrappers, would increase as the temperature slicers and dicers, feeders, gaskets, electrical increases. However, the temperature panels, refrigeration systems and more. System is restricted to 150°F for safety issues benefits include, among others, reduced need especially if the cleaning method is for cleaning chemicals. To date, bakeries have manual. been among the most avid users of the system, followed closely by meat and poultry processing The time that the cleaner remains in plants and confectionery processors. contact with the soil to be removed is also important, longer contact time Dry ice-blasting is a form of abrasive blasting, normally results in better or more where dry ice, the solid form of carbon dioxide, complete cleaning. is accelerated in a pressurized air stream and directed at a surface in order to clean. It can • Velocity or Force and Contact Time be used to clean food processing equipment to The amount of force or energy applied effectively decontaminate surfaces of Salmonella is another factor; the greater force enteritidis, E. coli, and Listeria monocytogenes will result in greater amounts of soil such that these microorganisms are not detectable removal. using conventional microbiological methods. Environmental Impact It may also be used to clean some equipment The discharge of waste materials from cleaning without disassembly and without producing fire or can impact the waste discharge from the facility. electrical hazards. This discharge may be required to be pretreated Vacuuming is an effective dry cleaning method prior to discharge to a municipal treatment facility. for food manufacturers who process low moisture It is important to control such factors as pH (acid materials such as flour, cinnamon and sugar. or alkaline), biological solids, and grease content. Certified explosion-proof or dust ignition-proof Sanitizer composition may also be restricted and industrial HEPA vacuums are recommended 5 DRAFT GUIDANCE Cleaners for RTE Food Plants

as part of OSHA Standards and Sanitation Rinse and remove excess water if Standard Operating Procedures. Vacuuming is needed an economical option for cleaning pipes, vents, tops of machinery, and floors. Collected materials We recommend for clean-in place (CIP) systems can be readily and easily disposed. that the following be monitored: • Concentration of cleaner solution and General Cleaning Program sanitizers • Verify flow rate We would recommend that a sanitary SOP • Time (sSOP) and sanitation maintenance schedule • Temperature be developed where RTE foods or food contact • maintain temperature of alkaline cleaning surfaces are processed or exposed. We solutions at or above 71°C (160°F) recommend that these sSOPs for cleaning and sanitizing equipment and floors identify: Wet cleaning of equipment, floors and other areas: • Equipment or area to be cleaned • Remove all RTE food before any wet • Disassembly of equipment, if necessary cleaning of floors and equipment in the • Frequency of cleaning and sanitizing area • Type and concentration of cleaning • Remove all RTE food from cooler before materials and sanitizers cleaning coolers , refrigeration condenser • Time/temperature of cleaning solutions units, or condensate drip pans and hoses • Flow rate (velocity) or pressure if CIP used We recommend for COP systems: • sSOPs for cleaning and sanitizing • Raw materials equipment should be equipment include the following: cleaned separately from finished product Lock out/Tag out-designated equipment if possible. Make sure that personnel power down and secure all cleaning tanks, brushes, and other equipment to prevent inadvertent equipment are sanitized before use. start up Sections of 21 CFR part 110 that are applicable to Dry clean/solids removal including a general sanitation program include packaging material 21 CFR 110.35, and 110.80(b) Pre-rinse equipment to remove visible food and other soils Floor Drains Apply cleaner ( correct type, concentration, temperature) Drains can be a continuing source of contamination Scrub or circulate of other surfaces and require special attention. Rinse to remove cleaner and food Therefore, care should be taken for floor drain residue cleaning; we recommend: Sanitize apply heat or sanitizer • Do not clean floor drains when RTE foods (correct temperature, correct time, are being processed or stored in the area correct concentration • Do not use high pressure hoses to clear Verify proper cleaning and or clean a drain, since it could create sanitizing aerosols and spread contamination • Brushes used to clean floor drains may • sSOPs for cleaning and sanitizing floors be at least ¼ (0.64 cm) smaller than the should include : diameter of the drain opening to reduce Removal of heavy soil and debris aerosols from brushing from floors • Use a splashguard to prevent splashing Clean other debris including during cleaning packaging material from floors • Utensils used for drain cleaning be Rinse floors with low pressure/low dedicated to that purpose and easily volume water at correct identified (color coded) temperature Use a brush (colored coded) for We recommend when a drain backs up and water floor use only or floor scrubber and flows into an area where RTE foods are being cleaner to scrub floor processed: Rinse floors with low pressure/low • Stop production volume water • Remove RTE foods from affected area Sanitize floors with appropriate • Clear the drain chemical sanitizer • Clean the affected area with an effective 6 DRAFT GUIDANCE Cleaners for RTE Food Plants

cleaner, rinse the drain, sanitize it and of potential microbial adulterants and associated remove excess water EPA recommended decontaminates and a list • Following drain cleaning, employees of EPA recognized sterilants are provided in the should change clothes, wash and sanitize accompanying DVD. hands before any contact with RTE food contact surfaces 6. RINSE - This step may or may not be necessary, • If bactericidal drain rings are used, monitor it depends on the type of sanitizer used and and replace them when appropriate directions given for use. Sections of 21 CFR part 110 that are applicable to 7. VERIFICATION - cleaning and sanitizing must be cleaning drains include verified by the approved sanitary SOP adopted by 21 CFR 110.10(b)(1), 110.10(b)(3), 110.35(a), and the facility. This verification must be sanctioned by 110.37(b)(3) local, state and federal officials before production if cleaning and decontamination is in response to • Fundamentals of Cleaning a contamination event. General Steps in the Cleaning and Sanitizing or 8. REMOVE LOCK OUT/TAG OUT - Once everything Decontamination of Food Processing Facilities: is dry and ready to power up, maintenance or 1. LOCK OUT/TAG OUT - This step involves designated personnel removes security features maintenance or designated personnel powering and powers up the equipment/machinery. down the equipment that is to be cleaned/ The following specific steps provide specific sanitized. They then secure it in such a way that guidance for the areas and operations listed: it cannot be powered up while being cleaned and cause injury to the cleaning/sanitizing crew. Design and Construction of Sanitary Equipment: Some equipment may have parts that need to run We recommend you obtain and study Sanitary during the process to ensure proper cleaning and Equipment Design which is a companion sanitizing. Personnel must be properly trained on document in this series. such operations to ensure safety. Equipment: We recommend you obtain and 2. DRY CLEAN UP or SOLIDS REMOVAL - This step study Sanitary Equipment Design which is a involves removing all solids including packaging companion document in this series. material and food scraps in, on, and around the equipment so proper cleaning and sanitizing can Equipment for Transport: Carts, forklifts, occur. mobile racks, pallet and pallet jacks are known sources of potential contamination. 3. CLEANING - There are three sub-steps within Therefore, we recommend that you dedicate cleaning: one set of such equipment to areas where Pre-rinse - To wet down surfaces. RTE foods are prepared and processed. We Wash - Detergent solution would be applied recommend that you clean and sanitize the at the appropriate concentration and allowed wheels of all transport devices before they to set for the appropriate amount of time. enter areas where RTE foods are processed Rinse - Remove the detergent and soil residue. It or exposed. Color coding should be used to is important for the food soil to remain suspended identify transport items dedicated to RTE food in the cleanser solution. preparation and exposure areas from those 4. SANITIZING - In this step sanitizer would be where raw materials are handled or stored. applied at the correct concentration and allowed Specific written cleaning and sanitizing to set for the appropriate amount of time. procedures should be prepared for any equipment that must be moved into the RTE 5. DECONTAMINATION – In the event of processing areas. This includes a record of contamination involving known microbial each time the movement is required and who adulterants, a specific decontamination agent carried out the procedure. selected from the antimicrobial agents approved for the specific application by the Environmental Water Systems: Water systems should be Protection Agency will be used in accordance properly designed, installed and maintained with the manufacturer’s instruction to assure the such that backflow and cross-connections destruction or neutralization of the adulterant. between potable and non-potable water lines Once an approved decontamination agent has and systems are not allowed. Hot and cold been applied, additional cleaning cycle may be water must be present at all hand washing required to remove any residue of the agent. A list stations. Hands free sinks, and hands free 7 DRAFT GUIDANCE Cleaners for RTE Food Plants

soap and towel dispensers should be used interior product zones are fully exposed and soil at every hand wash station. Also, all water can be washed away with a cleaning solution and treatment systems must be maintained and then sanitized with a properly diluted sanitizer. periodically inspected such that they do not become a source of microbial contamination. Clean out of place (COP) means a system used to Special consideration should be given to clean parts and pieces after disassembly. waste water systems that serve both the raw Critical food-contact surface means a surface that material and the finished goods processing contacts food, or a surface from which drainage areas to assure that cross contamination does onto the food or onto surfaces that contact the not occur. food in the ordinary process when the food is not Personnel: We recommend you obtain and study being subjected to an approved control process. Personnel Sanitation which is a companion Critical non-food contact surface or area means document in this series. a surface (other than food contact) that could, Sanitation: High pressure water hoses should through action of man or equipment contaminate not be used while RTE foods are exposed or a food that will thereafter not be subjected to the after equipment has been sanitized for use. approved control process, such air conditioning This helps prevent aerosols from contacting vents that might drip condensate during high RTE foods, food contact surfaces, food temperature water or steam cleaning activities. packaging materials and personnel handling Disinfect means the elimination of microorganisms these foods. We recommend you obtain and (excluding spores) from contaminated study Sanitation and Cleaners and Sanitizers environments, equipment, and surfaces which are companion document in this series. Ready-to-Eat (RTE) Food means a food that is customarily consumed without cooking by the Definitions consumer or that appears to be suitable for use Alkali or Alkaline Cleaners means cleaners with a without cooking. pH above 7.0 Sanitize is the reduction of microorganisms to Acid Cleaners means cleaners with a pH below levels that public health authorities considered 7.0 safe Chlorinated Alkaline Cleaners means an alkaline Sterilize is the complete removal of all cleaner with the addition of a chloramines (should microorganisms including spores. this be chlorine?) for an aid in protein removal Water Conditioners materials added to cleaners to treat minerals in the water used for cleaning. Cleaning means removing soils, dirt, or other material that may support the growth of We recommend that you also familiarize yourself microorganisms or inhibit the sanitizing of a with the definitions found in 21 CFR 110.3 which surface. you can access on FDA’s internet website for Center for Food Safety and Applied Nutrition Clean in place (CIP) means a system to clean (CFSAN). piping or equipment without disassembly, where

References and Acknowledgements

Making the Right Choice – Cleaners. R. Bakka Ed. Ecolab Inc. 1997 Innovative Food Defense Project

Contact Dr. Cosby at 919-733-7366 ([email protected]) for more information

Sanitizers and Decontamination for RTE Food Plants

Introduction • Cleaning tools (brushes, brooms, scrapers) If a food processing plant and some or all of the • Condensate drip pans refrigerated or frozen ready-to-eat (RTE) foods • Forklifts, hand trucks, trolleys and racks produced has been contaminated with microbial • Trash cans adulterants, careful steps must be taken to rid • Pallets for ingredients and product the plant of these adulterants and help prevent their recurrence. This document is provided in a Utilities series to address recommendations on controls • Compressed air systems including air to reduce the potential of contamination of RTE filters foods. The topics addressed include: • Ice makers • Refrigeration systems including freezers • Personnel • The design, construction and operation of Common Situations that have resulted in your plant Contamination of RTE Foods • The design, construction and maintenance of equipment, and There are a number of scenarios that have been • Sanitation Controls identified as having contributed to the microbial contamination of RTE foods. These include but This specific document is provided to give are not limited to the following: recommendations regarding sanitizers in the clean up and control of microbial contamination • Used equipment is brought from storage in a RTE food plant. and installed in the process line without through cleaning Potential sources of contamination in RTE foods • A new employee who is not properly can include but are not limited to: trained is delegated to help clean process equipment Food Contact Surfaces • Raw or under-processed food is brought • Fibrous and porous-type conveyor belts into the area where cooked food is held • Filling and packaging equipment • Maintenance workers move from raw • Work Tables areas to packaging machines without • Belts, peelers and collators changing clothes or properly washing their • Containers, bins, tubs, baskets hands • Slicers, dicers, shredders and blenders • Heat exchangers become compromised • Utensils (have pinhole leaks) • Gloves • Equipment parts, food bins, tubs, etc. are cleaned on the floor Non-contact Surfaces • Improper use of footbaths • In-floor weighing equipment • Employees arrive for work in dirty clothes • Air and water hoses or boots and are not provided with a • Hollow rollers for conveyances change • Equipment framework • Open bearings Who Should Follow The Guidance in this • Motor housings Document? • Maintenance tools (screwdrivers, wrenches) We would recommend that any processor of RTE • On/Off switches foods would benefit by following the guidance • Equipment control Panels provided by this document and other documents DRAFT GUIDANCE Sanitizers and Decontamination for RTE Food Plants

in this series. The guidance is especially formulated for those processors who have had • Resistance to organic matter, detergent products recalled or their facility closed due to and soap residues, water hardness and pH microbially contaminated foods either by the FDA variations or the NCDA&CS. However, we believe that all • Non-toxic and non-irritating RTE Foods processors will benefit from following • Water soluble these recommendations to help avoid the product • Acceptable odor or no odor contamination/plant closure scenario. • Stable in concentrate and use dilution How Does this Document Relate to the FDA • Easy to use • Readily available GMPs and Other Regulations? • Inexpensive This document is not meant to provide any • Easily measured in use solution Guidance which contradicts FDA’s GMPs. If Sections of the 21 CFR Part 110 and Section 178 one studies the GMPs, you find that binding must be considered in all decisions regarding requirements for the processing of food are given sanitation for plants producing RTE foods. These as shall while the non-binding recommendations include but may not be limited to the following: are given as should. The guidance and recommendations in this document are meant to Sanitizing complement those of the GMPs. Other regulations Reducing and destroying disease and spoilage must be followed such as milk products producers organisms on a surface to an acceptable level must follow the Grade A Pasteurized Milk Ordinance and shellfish products producers must Methods of Sanitizing follow the National Shellfish Sanitation Program • Heat, hot water and steam Model Ordinance. • Ultraviolet light and other irradiation • Chemical Understanding Your Ingredients, Process, Heat Sanitizing Cleaners and Sanitizers and Finished RTE • Flowing steam to 200°F for 5 min Product • Hot water at 170°F for 2 min on equipment, One must understand their intended RTE 5 mins. when pumped food product thoroughly to determine the best • Hot air is much less effective because it is ingredients, process, packaging and necessary dry heat. cleaning and sanitation processes. This document Advantages of Heat Sanitizing especially addresses the needs of sanitizers and • Relatively easy to measure disinfectants and provides recommendations • No residues and guidance to help provide the framework for • Good penetration of joints and crevices controlling microbial contamination of RTE foods. • Dries quickly Sanitizers for RTE Food Plants • Broad spectrum kill of microorganisms General Considerations. We would recommend Disadvantages of Heat Sanitizing that you separate RTE food production areas from • Makes area hot raw food areas. In general, the areas where RTE • Could cause burns foods are prepared processed and stored before • Equipment must be cooled before use they are finished RTE foods should be isolated • Increases water use (however, water can as much as possible to reduce the potential for be reused in rinsing or cleaning solutions) contamination of RTE foods via air, aerosols or • May cause parts of moving equipment to traffic of employees, equipment and supplies. bind Equipment washing areas should be isolated. Cleaning with high pressure systems should Chemical Sanitizers only take place in such a manner that exposed Most chemical sanitizers are combined food and food contact surfaces are not subject to with potable water. Standards set by U.S. overspray and aerosols. Public Health Department indicate potable water has less than 1 Colony Forming Unit Desirable Properties of a Sanitizer (CFU) per 100 per 100 ml. The U.S. Food • Broad spectrum activity against vegetative and Drug Administration (FDA) is primarily cells and spore formers, yeast, molds and involved in evaluating residues viruses 2 DRAFT GUIDANCE Sanitizers and Decontamination for RTE Food Plants

• Approved under 21 CFR 178.1010 inexpensive and do not foam. Chloramines • Also regulated under FIFRA (Federal are replacing chlorine for water and Insecticide Fungicide and Rodenticide Act) wastewater treatment since they are • Must be used according to label directions less likely to produce trihalomethane • May be proprietary compounds compounds, are less reactive with organic matter, are less affected by pH Advantages of Chemical Sanitizers than chlorine and do not affect the taste • Use less energy of water. They are more stable than • Not very temperature dependent chlorine solutions. The disadvantages of • Can be compounded to special needs chloramines are that they are slow acting • Some have residual effect compared to chlorine and require a long Disadvantages of Chemical Sanitizers contact time. Chloramine T is the common • Potential for residues name for commercial applications of • Spills can be a problem chloramines and is available in tablet • Loss of potency on storage form to be mixed in water and applied • Require monitoring kits to surfaces. Halamines are similar • Have limited effectiveness against certain to chloramines but may be used as organisms antimicrobial coatings of surfaces. Types of Chemical Sanitizers • Iodophors are sanitizers composed of an acid and a surfactant carrier. The • Hypochlorite (Sodium or Calcium) Dilute advantages include being one of the most chlorine bleach is a common sanitizer for effective sanitizers especially against equipment and surfaces in food processing molds and yeasts. There are approved as facilities. The effective compounds in no-rinse food contact up to 25 ppm. They a chlorine solution are hypochlorite are less toxic, have a broader pH range, and hypochlorous acid. It is effective in less corrosive when used below 120°F, killing most microorganisms (spores and and loose less of their effectiveness when parasites such as Cryptosporidium are compared to chlorine. It is a good sanitizer resistant) and is relatively inexpensive. for hand sanitizing and foot or boot baths. Bleach solutions are most effective at a pH Disadvantages are causing staining and of 6.5 to 7.5 and concentrations must be no equipment discoloration, may be affected greater than 200 parts per million for no by water hardness. Low temperatures rinse uses (21CFR178). Lower amounts of result in loss of efficacy and their use is HOCL are produced as the pH increases restricted to a maximum of 120°F. Iodine and consequently the efficiency decreases. will vaporize and is very corrosive at this It is very important to thoroughly rinse temperature. It is not normally used as equipment following cleaning with an a CIP sanitizer for this reason plus it will alkaline cleaner if chlorine is used as a foam. More expensive than chlorine. sanitizer, especially if the pH is below 4.0. Applicators are available so that the Disadvantages of chlorine bleach are that sanitizer can be dispensed as a mist in it can be corrosive on certain surfaces processing facilities. and quickly loses its killing power in the • QUATS These are quaternary ammonium presence of food soils, oil, or other organic compounds or QACs. The maximum material. Effective cleaning is absolutely concentration that is allowed by FDA for required if bleach is used for sanitation. a no-rinse food contact sanitizer is 200 There is some concern that chlorine may ppm but concentrations can be higher for react with materials in water and produce floors, drains and walls. The advantages trihalomethane compounds. are non-toxic, odorless, colorless, non – corrosive, stable to heat, and relatively • Inorganic/Organic chlorine compounds stable to organic soils. They are effective Similar to hypochlorites, inorganic over a fairly wide pH range. QACs also and organic chlorine compounds (i.e., have surfactant or wetting agent properties chloramines, halamines) are effective similar to detergents and can aid in against bacteria, fungi and viruses; emulsifying organic compounds. They not affected by hard water, effective are less effective against gram negative at fairly low temperatures; relatively organisms (i.e., E. coli, Salmonella) 3 DRAFT GUIDANCE Sanitizers and Decontamination for RTE Food Plants

but more effective against Listeria enclosed areas but may cause irritation to monocytogenes than chlorine. Their the mouth and nose, thus respiratory PPE effectiveness is reduced by some cleansers may be required during its application. It so a rigorous rinse cycle is required after is compatible with almost all surfaces and cleaning. They can also be used in misting the gaseous form is often recommended (aerosol) applications. for sensitive electronic equipment. It is not as stable as PAA and can rapidly degrade • Acid anionic sanitizers These compounds on contact with wood and some metals. are made of organic or inorganic acids (i.e., phosphoric, formic, or acetic acids) • Chlorine Dioxide (liquid and gas) Chlorine plus a surfactant, so they have similar dioxide is often used to treat drinking emulsifying properties as QACs. They are water, wastewater and production rinse effective against a broad range of bacteria water in the produce industry. It is also (but not mold), nontoxic, and non-corrosive. used as a surface disinfectant. It is a They must be used at low pH (2-3) and are stronger oxidizer than other chlorine not suitable for CIP application. sanitizers, is effective over a wide pH range and is less affected by organic matter. • Peracetic acid sanitizers (PAA) These Chlorine dioxide is more expensive than sanitizers are composed of acetic acid other chlorine types and must be produced and hydrogen peroxide and will form by a generator on site. Generators are peracetic acid in water. It is a strong commercially available. Chlorine dioxide oxidizer, considered stronger than chlorine gas is used as a sanitizer for medical and chlorine dioxide. It is effective against facilities, laboratories, and pharmaceutical bacteria, fungi, viruses, spores and clean rooms and is becoming more can be used against parasites such as popular in the food industry. It is highly Cryptosporidium. It has some cleaning toxic so it can only be used in tightly properties and can be helpful in removing enclosed areas, but has a short treatment biofilms. It is more stable than hydrogen time and equipment is available to treat peroxide and has greater effectiveness any by products. It is effective against in the presence of soils. It is safe for bacteria, fungi, viruses, parasites, and use on stainless steel but may corrode very effective against spores at higher aluminum and plastics. It breaks down concentrations. It is often used for to nontoxic compounds of acetic acid and remediation (i.e., decontamination of the water so has little environmental impact Hart Senate Office building during the as a waste product. It can be used in 2001 anthrax attacks). EPA has performed gaseous form but the treated area must studies with chlorine dioxide and approved be totally enclosed. Gaseous PAA has the liquid form for treating hard surfaces been approved by the EPA for treatment and the gas for fumigating enclosed of anthrax spores. A disadvantage is facilities. that it produces a strong odor which can irritate the eyes and mucous membranes • Ionizing Radiation (Irradiation) Irradiation is and can be very caustic on exposed skin. commonly used (and has FDA and USDA Therefore, proper PPE must be used during approvals) in the food industry on fruits and its application. vegetables, meat and poultry products, water and air to reduce contaminating • Hydrogen Peroxide (liquid and gas) Hydrogen microorganisms. Microorganisms are peroxide is effective against bacteria and destroyed in a matter of seconds. In fact, fungi and can be effective against spores spices and flour are routinely treated with and parasites such as Cryptosporidium irradiation to kill microorganisms. High and Giardia at high concentrations. frequency ultraviolet (UV) light, gamma ray Hydrogen peroxide is more effective and X-ray irradiation have enough energy in its gaseous form and in this form to break chemical bonds and remove may break down protein toxins such as electrons from molecules which causes the Staphylococcal enterotoxin and prions, the breakdown of microorganisms. E-beam causative agent of Mad Cow Disease. It is (electron beam) radiation is produced nontoxic at low concentrations but can be by a linear accelerator and generates caustic at concentrations above 35%. The electrons to eliminate microorganisms. gaseous form is often used as a fumigant in The energy from these sources are high 4 DRAFT GUIDANCE Sanitizers and Decontamination for RTE Food Plants

enough to destroy microorganisms but too caustic (i.e., acetic acid). Their usefulness low to induce radioactivity in any material. is due in large part to the low pH of working Irradiation of fruits and vegetables can solutions. Their effectiveness against extend shelf life of the product by reducing microorganisms varies depending on the the number of spoilage organisms. Pre type so the operator needs to make sure packed or bulk foods to be sterilized are the acid chosen meets their specific needs. placed on conveyor belts and carried into For example, citric acid is recommended irradiation chambers which are shielded for use on some viruses (i. e., Foot and to prevent the radiation from escaping the Mouth disease, FMD) and USDA has found chamber. Packaging materials, equipment that 2% citric acid is effective against FMD and some tools can also be sanitized by on wood surfaces. Acetic acid (5% glacial irradiation when placed on a conveyor belt acetic acid) has widespread use and is and run through the irradiation chamber. applied as a mist or by spraying. It is also The use of radiation is limited due to used as a COP sanitizer. high cost, specific safety requirements and waste disposal. It also has limited • Electrolyzed water Electrolyzed water penetration ability. Irradiation can also is a relatively new technology that is a harm certain plastics so dosage must be powerful sanitizer for drinking water and tightly controlled. waste water, and surface disinfectant applications in the dental, medical and • Ozone Ozone sanitizing can be a single- food industries. It is made by passing step process. Ozone, or O3, is a strong salted tap water through a charged oxidizing form of oxygen. It is a strong electrolytic cell which produces a reduced disinfectant and deodorizer that is second high pH solution (which is an effective only to fluorine in oxidizing power and is cleaner and biofilm remover) and an reportedly up to 50 percent stronger than oxidized low pH solution. The low pH chlorine as an oxidizer and it acts 3,000 solution is collected and used as the times more rapidly, without the toxic risk of sanitizer and contains hypochlorous chlorine. It was approved for use in water acid, ozone and other oxidizing agents. by the FDA in 2001. Ozone and ozonated It is effective against bacteria, viruses, water is used in the seafood industry as fungi, and spores and is currently being a disinfectant for air and water and has used in the poultry, meat, produce and been approved for direct contact with food. beverage industries. It is non-toxic It is used to disinfect fruit and vegetables (although it can be an irritant due to the and has been approved by USDA for use low pH) and safely disposed of after use in meats and poultry. It is effective against with little environmental considerations. bacteria and viruses but fungi and spores It is considered to meet EPA regulations are resistant. Currently ozonated water since the main agent is hypochlorous shows promise as an equipment and acid. Check with the equipment supplier surface disinfectant. No waste is involved for details. Electrolyzed water solutions since ozone will break down to oxygen are only stable for a day so an on site and it is certified by the National Organic generator is required and several are Program for use on organic foods. The commercially available. Initial investment primary use of ozone to date has been in the generator may be high but many for conveyor and equipment cleaning, think the cost savings over time more wastewater treatment and odor oxidation, than make up for the initial investment. with growing application in air systems in Electrolyzed water can be corrosive to locker and rest rooms. A disadvantage is some surfaces and soils will reduce its on site equipment is required to generate efficacy. the ozone which may be cost prohibitive. The efficacy of ozone gas is also limited by • Alcohol Pads are primarily used in the food relative humidity in the area and rapidly processing facilities for sanitization to meet loses its effectiveness below 70% humidity. HACCP and food safety requirements. Soft absorbent, non-woven pads saturated with • Organic acids Examples of acid disinfectants 70% isopropyl alcohol may be used in the are acetic, citric, and propionic acids food processing facilities for sanitation to They are non-toxic at concentrations for meet HACCP and food safety. Individually use but concentrated solutions can be wrapped alcohol wipes are also ideal 5 DRAFT GUIDANCE Sanitizers and Decontamination for RTE Food Plants

for cleaning and sanitizing thermometer as GRAS. All three, along with chlorine probes to prevent cross-contamination. dioxide gas have also been approved for Isopropyl alcohol may a useful disinfectant anthrax decontamination by the EPA. in facilities that require routine dry or low water cleaning. Hypochlorites • Inexpensive • Fumigation is used to treat processing • Broad spectrum kill plants, boxcars, and ships. It is one of • Sensitive to pH the quickest and most effective ways • Less effective in presence of organic to eliminate pests from processed food materials and commodities. As a gas, a fumigant • May cause allergic reactions consists of separate molecules that are much smaller than the droplets of a fog or Organic Chlorine Compounds mist. Fumigants can penetrate very small • Not as sensitive as hypochlorites to pH spaces where pests live, such as those • Require a longer exposure time in flour. Fumigants can even penetrate • Broad spectrum of destruction seemingly solid items like brick, concrete, • Commonly known as Chloramine T and wood. Advantages of fumigants Iodine Compounds include effective, fast-acting, total pest • Usually used with non-ionic compound eradication, no residues, and penetration as a wetting agent and referred to as an into hard to reach areas. Disadvantages iodophor include toxicity, highly trained licensed • Color is proportional in intensity to applicators may be required, area must concentration be tightly confined, and expense. Some • Non-irritating to skin residues may be hard to remove from • Not affected by hard water fumigated materials. Methyl bromide, formaldehyde, and ethylene oxide are Quaternary Ammonium Compounds three gases that have received crisis (QUATs or QACs) exemption status from EPA to fumigate • Stable office spaces, mobile homes and other • Can form bacteriostatic films enclosed places and mail, in response to • Residues can be negative or positive a suspected anthrax contamination. These • Not effective against spores and viruses compounds are now rarely used or used • Expensive only in specific niche areas (i. e., medical • Foam on mechanical application

equipment requiring cold sterilization) Acid-Anionic Surfactants because of their toxicity and cancer risks. • Effective only at acid pH Chlorine dioxide, vaporized hydrogen • Slow activity against spore formers peroxide, peracetic acid and ozone are • Foam is a problem in mechanical or CIP quickly becoming the fumigants of choice applications in an increasing amount of food processing • Bacteria can become acid-adapted situations. These sterilants have been used in the medical and pharmaceutical Hydrogen Peroxide (HP) H2O2 fields for many years and the equipment • Used widely in medical field, limited use in and application procedures are beginning food industry to become more cost effective for food • FDA approval for sterilization of equipment processing facilities. The initial equipment and packaging for aseptic operations purchase or rental, plus technical • Broad spectrum sanitizer services may be expensive but should • Slightly higher activity against gram be considered as part of the remediation negative than gram positive organisms response to a contamination event; and an • Eye and skin irritant at high concentrations investment in future sanitary innovations (5% and above) for the facility. The application of these • Safety precautions and personal protective sterilants is quick and can be used in CIP equipment should be used situations. Vaporized hydrogen peroxide and ozone are considered environmentally Ozone (O3) friendly since the by-products are water • Widely used since early 1990’s for the and oxygen and peracetic acid is classified disinfection of water

6 DRAFT GUIDANCE Sanitizers and Decontamination for RTE Food Plants

• Since 1997 approved for use in U.S. food MSDS processing (GRAS), Generally Recognized • Safe use and handling information as Safe • Physical, health, fire and reactivity hazards • Current use in wine industry , fresh- cut • Precautions produce industry, produce storage • Appropriate personal protective equipment facilities, food processing, bottled water (PPE) when using chemical and beverage industries • First-aid information and emergency • Produced by interaction with oxygen (O2) procedures and electricity to produce (O3) • Manufacturer’s name, address and phone • Unstable gas and will breakdown to number oxygen after oxidizing organic matter • Preparation date of MSDS (microorganisms) • Hazardous ingredients and identity • Broad spectrum sanitizer and effective information against biofilms • Kept in accessible location\ Employees • Must be generated on demand and cannot right-to-know be stored • Expense of ozone generating equipment Registration of Chemical Sanitizers and employee safety • Sanitizers are subject to registration under • Toxic gas, Occupational Health and Safety the Federal Insecticide, Fungicide, and Administration (OSHA) established eight Rodenticide Act (FIFRA) administered by –hour continuous maximum exposure the U.S. Environmental Protection Agency limit of 0.1ppm and short term (15 min.) (EPA). Application of a sanitizer not exposure of 0.3ppm recommended for a specific use can be • Equipment cost and monitoring (safety) authorized during an emergency situation issues have prevented wide use in smaller according to Section 18 of FIFRA. facilities • You should use sanitizing solutions with the FDA Approval conditions of use authorized under FIFRA, which should be on the product label. The U.S. Food and Drug Administration is primarily • Contact the manufacturer or supplier of involved in evaluating residues from sanitizer use the sanitizer for specific recommendations that enter the food supply, Any antimicrobial agent regarding factors which may influence and its maximum usage level for direct use on efficacy (temperature, pH, water hardness). food or food contact surfaces must be approved by FDA. Approved no-rinse food contact sanitizers Sanitation Monitoring and Verification and non product contact sanitizers, formulations Sanitation verification is part of the overall and usage levels are listed in CFR 178.1010. remediation strategy and therefore a detailed plan Hazard Communication Program should be designed and in place before cleaning • Hazardous chemical inventory – name, and sanitation begins (see the Decontamination storage area Analysis and Verification module in this series). • Chemical labeling procedures – name, Verification of the sanitation process should also manufacturer’s name, address, potential be part of the normal sanitary SOP. In addition, hazards sanitation fluids must be monitored to ensure the • Material Safety Data Sheets (MSDS) proper concentration is always used. There are a • Employee training variety of test strips available in the marketplace • Written plan (Hazard Communication to measure concentrations of sanitizers. Standard) Sections of 21 CFR 110 Applicable to Sanitation Hazardous Materials Monitoring • Chemical – potential health hazard or may 110.35(a) 110.35(a), 110.35(b), 110.35(d), 110.35(d) cause injury (1), 110.35(d)(2), 110.35(d)(5), and 110.80(b)(1). • OSHA requires HCS • Right-to-know (HAZCOM) – inform The following specific steps provide specific employees of chemical hazards & provide guidance for the areas and operations listed: training Design and Construction of Sanitary Equipment: • Material Safety Data Sheets ( MSDS)- We recommend you obtain and study Sanitary OSHA requirement Equipment Design which is a companion 7 DRAFT GUIDANCE Sanitizers and Decontamination for RTE Food Plants

document in this series. The specific type of adulterant involved will determine: Equipment: We recommend you obtain and study Sanitary Equipment Design which is a companion • The hazards to which response personnel document in this series. may be exposed • The need for medical and environmental Equipment for Transport: Carts, forklifts, mobile monitoring required racks and pallets are known sources of potential • The containment areas needed contamination. Therefore, we recommend that • The decontamination agent and process you designate one set of such equipment to areas required where RTE foods are prepared and processed • The personal protective equipment (exposed). We recommend that you clean and required sanitize the wheels of all transport devices before • The disposal method to be used they enter areas where RTE foods are processed • The analytical testing required or exposed. We recommend that you use a • The parameters for determining when mechanism such as color coding to distinguish the facility is suitably cleaned and between transport items used in RTE foods decontaminated to return to production. preparation and exposure areas and those where • How returned product, raw materials, in raw materials are handled or stored. process materials, plant equipment, and Water Systems: Water systems should be properly facilities will be addressed designed, installed and maintained such that • The size and scope of the cleaning and backflow and cross-connections between potable decontamination effort required and non-potable water lines and systems are not • Potential problems that might be allowed. Hot and cold water must be present at encountered all hand washing stations. Hands free sinks and Clearance goals are the objectives of what exactly hands free soap and towel dispensers should is expected during the remediation process and be used at every hand wash station. Also, all what is the expected result after completion of the water treatment systems must be maintained process. and periodically inspected such that they do not become a source of microbial contamination. Medical professionals, hygiene specialists, High pressure water hoses should not be used and environmental engineers may be required while RTE foods are present or after equipment to participate in the planning, execution, and has been sanitized for use. This helps prevent evaluation of the response. aerosols from contacting RTE foods, food contact surfaces, food packaging materials and personnel A Public Relations team may be required handling these foods. to gather all pertinent information of the remediation process and release this information Personnel: We recommend you obtain and study to employees, the media, and the public as Personnel Sanitation which is a companion necessary. Coordination with regulatory and document in this series. law enforcement officials on information to be released and when will be required. It is Decontamination in Response to an critical that only one individual be assigned the Intentional Bioterror Attack task of spokesperson to ensure complete, non- contradictory and consistent communication to In situations where known or suspected food the outside world. The communication team along adulteration has occurred intentionally, the with owners, managers, supervisors, regulatory decontamination required is much more complex and law enforcement officials will contribute to than routine cleaning and sanitation. The any reports required but the reporting should be procedures are similar but must be better assigned to one individual. documented, according to law enforcement regulations. The requirements can be more Removal of equipment and personnel traffic and demanding and the number of agencies involved safety will also require more precise planning. greater. Local, state and federal law enforcement Safe, transition, warm, hot and exclusion official’s involvement will be necessary. Besides contaminant zones may need to be defined, clearly the financial and incident management issues marked, and strenuously enforced. Depending involved, the following issues also will need to be on the virulence of the contaminant, individual addressed: staff may be required to monitor all response personnel, their fitness to respond and vital signs, 8 DRAFT GUIDANCE Sanitizers and Decontamination for RTE Food Plants

their donning of personal protective equipment, their Definitions entry and exit times, their work assignment, their partner, their decontamination procedure followed, Clean in place (CIP) means a system to clean piping their accomplishments and problems, their recovery or equipment without disassembly, where interior time, their condition following their entry, and their product zones are fully exposed and soil can be departure from the site. washed away with a cleaning solution and then sanitized with a properly diluted sanitizer. Another individual may be needed to do the same level of monitoring and documentation for response Clean out of place (COP) means a system used to clean supplies, equipment, and waste materials. The parts and pieces after disassembly. same type of monitoring and documentation will be Critical food-contact surface means a surface that required for the specific materials, equipment, raw contacts food, or a surface from which drainage materials, and product being decontaminated. onto the food or onto surfaces that contact the food All of this information must be available to the in the ordinary process when the food is not being individual in charge of the response in a clear subjected to an approved control process. format and timely manner. Many aspects of this Critical non-food contact surface or area means a documentation are specified by applicable standards surface (other than food contact) that could, through and regulation. Decisions made before, during, and action of man or equipment contaminate a food following the response will be based on the best and that will thereafter not be subjected to the approved most current information available from this type control process. of documentation. It is important to remember that finances drive an event response, but the priorities Disinfect means the elimination of microorganisms must be human health and safety, animal health and (excluding spores) from contaminated environments, safety, protection of the environment, and business equipment, and surfaces continuity. FIFRA (Federal Insecticide, Fungicide, and In significant contamination events the coordination Rodenticide Act) sanitizers are subject to registration, of functions of event characterization, response administered by U.S. Environmental Protection logistics, medical and environmental monitoring, Agency safety, operations, sample analysis, classification, Finished RTE Food means a refrigerated or frozen waste handling and disposal must be closely RTE Food that has been processed by an approved coordinated. process and is packaged. In a major event special hazardous material response Ready-to-Eat (RTE) Food means a food that is customarily and disposal contractors usually prove to be worth consumed without cooking by the consumer or that the cost. This is because of they do this regularly, are appears to be suitable for use without cooking. familiar with the regulations, and they have access to the equipment, personnel, supplies and services FDA refers to the U.S. Food and Drug Administration. required to make an efficient response possible. By using response organizations or consultants NCDA&CS refers to the N.C. Department of Agriculture with whom the regulatory agencies are familiar the and Consumer Services. clean-up and return to production may be expedited. These organizations need to be managed by a Ozone (O3) means an oxidizer (sanitizer) produced by process knowledgeable company representative the reaction of oxygen and electricity and provided with clear specifications as to what the OSHA means Occupational Health and Safety activity objectives and performance parameters will Administration be. Every contamination event is different, but the approach to resolve them should be the same. Sanitizer refers to a substance that reduces microbial contamination on inanimate surfaces to levels that A list of potential microbial adulterants and are considered safe from a public health stand point. associated EPA recommended decontaminants and a list of EPA recognized sterilants are provided in the We recommend that you also familiarize yourself with accompanying CD. the definitions found in 21 CFR 110.3 which you can access on FDA’s internet website for Center for Food Safety and Applied Nutrition (CFSAN).

9 DRAFT GUIDANCE Sanitizers and Decontamination for RTE Food Plants

References and Acknowledgements Food Related Fumigation – Classification 8 Training Substantial portions of this document were suggested Manual. MP450-PD-8-05N. Donald R. Johnson, editor. or directly obtained from FDA Draft Guidance University of Arkansas Cooperative Extension Service Document: Control of Listeria monocytogenes in Printing Services. Refrigerated or Frozen Ready-to-Eat Foods. Feb. http://plantboard.arkansas.gov/PlantIndustry/ 2008 Documents/MP450Class8FoodRelatedFumigation. pdf 7 CFR 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on processed Giambrone, C. J. 2011. Safety and Sanitation. Multiply products labeled as ‘‘organic’’ or ‘‘made with organic your Meat and Poultry Attack. Food Quality 18(5) (specified ingredients or food group(s)).’’ October/November. Pg 29-35. Wiley-Blackwell. http://www.gpo.gov/fdsys/pkg/CFR-2011-title7-vol3/ pdf/CFR-2011-title7-vol3-sec205-605.pdf Giambrone, C.J. 2011. Contamination Control Chlorine Clean. Food Quality 18(5) October/ 21 CFR Part 173. Secondary Direct Food Additives November. Pg 36-40 Wiley-Blackwell. Permitted in Food for Human Consumption. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ Hampton, B. 2000. Use of Ozone for Winery and cfcfr/CFRSearch.cfm?CFRPart=173 Environmental Sanitation. Practical Winery and Vineyard Journal. Jan./Feb. 2000. 21 CFR Part 184. Direct Food Substances Affirmed as Generally Recognized as Safe. McDonnell, G. E. 2007. Antisepsis, Disinfection, and http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ Sterilization. Types, Action and Resistance. ASM cfcfr/CFRSearch.cfm?CFRPart=184 Press Washington, D.C. 40 CFR 180.940 - Tolerance exemptions for active and Pesticides: Topical & Chemical Fact Sheets. U. S. inert ingredients for use in antimicrobial formulations Environmental Protection Agency. (Food-contact surface sanitizing solutions). http://www.epa.gov/pesticides/factsheets/index.htm http://www.gpo.gov/fdsys/pkg/CFR-2010-title40-vol23/ pdf/CFR-2010-title40-vol23-sec180-940.pdf Pfuntner, A. 2011. Sanitation, Sanitizers and Disinfectants: The Chemicals of Prevention. Food Bradley, R.L. and Bohner, H.F. 1992. Properties of Safety Magazine August/September 2011. Chemical Sanitizers. Wisconsin Center for Dairy Research. Sanitizers for Food Plants. 2007. UC Davis Seafood Network Information Center. Sea Grant Extension Boufford, T. 1998. Making the Right Choice- Sanitizers. Center. Ed. Ecolab Inc. http://seafood.ucdavis.edu/pubs/sanitize.htm Compatibility of Material and Electronic Equipment Schmidt, R. H. 2003. Basic Elements of Equipment with Hydrogen Peroxide and Chlorine Dioxide Cleaning and Sanitizing in Food Processing and Fumigation. Assessment and Evaluation Report. Handling Operations. University of Florida IFAS EPA/600/R-10/169. December 2010. Office of Research Extension. http://edis.ifas.ufl.edu/fs077. and Development National Homeland Security Research Center. www.epa.gov/ord.

Food Equipment Cleaning and Sanitizing: Water Chemistry and Quality, Sanitizer Properties. 2012. Arizona Department of Health Services. http://www.azdhs.gov/phs/oeh/fses/fecs_wcq.htm

10 DRAFT GUIDANCE Sanitizers and Decontamination for RTE Food Plants Table 1. Properties of Chemical Sanitizers

Hypochlorites (bleach) Chlorine Chloramines (Chloramine T) Germicidal Action Bacteria, viruses, fungi Bacteria, viruses fungi Bacteria, viruses, including parasite and including parasite and fungi slower acting bacterial spores at high bacterial spores at than bleach, chlo- concentrations (5,000- high concentrations rine. Not effective 6,000 ppm EPA) against spores General uses Food contact surfaces, Cooling, pool and spa Food contact sur- rinse water for fruits and water, rinse water for faces and utensils, vegetables, CIP, utensils, fruits and vegetables, drinking water and 200 ppm for no rinse ap- food contact surfaces, other water sources plication (FDA) utensils Form Concentrated solution, Compressed gas or White powder powder or pellet liquid General use dilution 25 – 200 ppm 25 – 200 ppm 50 – 200 ppm pH Best at pH 6.0-7.5 Best at pH 6.0-7.5 Best at pH 6.0-7.5 Temperature Cold water (maximum at Cold water (maximum Cold water (maxi- 115oF) at 115oF) mum at 115oF) Corrosion Slight to moderate, cor- Slight to moderate, Low rosive below pH 6 corrosive below pH 6 Stability (use dilu- Fair Fair Good, better than tion) hypochlorites Toxicity (use dilution) Low Low Low Irritant (use dilution) Low Low Low Vapors (working con- None at correct pH None at correct pH None at correct pH centration) Penetration Poor Poor Poor Hard Water Decreased efficacy in Decreased efficacy Decreased efficacy hard water (>500 ppm) in hard water (>500 in hard water (>500 ppm) ppm) Organic soil toler- Marked loss of efficacy Marked loss of ef- Superior to hypo- ance in presence of organic ficacy in presence of chlorites, but some soils organic soils efficacy loss evi- dent Residual biocide ac- None None Slight tivity after use Advantages Inexpensive, good Inexpensive, good Fewer byproducts choice for stainless steel choice for stainless and longer lasting surfaces and utensils steel surfaces than bleach, low toxicity Disadvantages Requires strict pH and Requires strict pH and Slower acting than concentration control for concentration control bleach maximum activity. Highly for maximum activ- corrosive if improperly ity. Highly corrosive if used. Possible carcino- improperly used genic by-products 11 DRAFT GUIDANCE Sanitizers and Decontamination for RTE Food Plants Table 1. Properties of Chemical Sanitizers

Acidified Sodium Chlorine dioxide Chlorine Dioxide Chlorite (ASC) (gas) (liquid) Germicidal Action Bacteria, viruses, fungi Bacteria, viruses, fungi Bacteria, viruses, including parasite and including parasite and fungi including bacterial spores at high bacterial spores at parasite and bacte- concentrations high concentrations rial spores at high concentrations General uses Surface disinfectant, Area fumigation and Surface disinfec- water water sources tant, water Form Liquid Gas Liquid General use dilution 500 - 1200 ppm 3 ppm residual for wa- 3 ppm residual for ter rinse, 0.5 to 30 ppm water rinse, 200-500 for sanitation ppm for sanitation pH 2.5 – 2.9 Wide range (4.0 - 9.0) Wide range (4.0 - 9.0) Temperature Most effective at low to Good at low tempera- Good at low tem- warm temperatures tures peratures Corrosion Minimal Minimal Yes, under acidic conditions Stability (use dilu- Good Moderate Moderate tion) Toxicity (use dilution) Relatively nontoxic Yes Yes Irritant (use dilution) Yes Yes (oxidizer) Yes (oxidizer) Vapors (working con- Minimal Dangerous Dangerous centration) Penetration Good Good Poor Hard Water Minimal effect Minimal effect Minimal effect Organic soil toler- Yes Yes Yes ance Residual biocide ac- No No No tivity after use Advantages FDA approved for use on No residues, requires FDA approved meat, seafood, raw agri- lower concentra- for use on meat, culture commodities and tions compared to seafood, raw water (21CFR173.325), hypochlorites, does agriculture com- effective in removing not form chlorinated modities and water milkstone and hard wa- organic compounds (21CFR173.300), ter films, good for CIP does not form chlorinated organic compounds Disadvantages Low pH required Must be produced on Requires auto- site, expense of gas mated equipment generating equip- for production, toxic ment, requires gas vapors produced at tight enclosure for use high temperatures

12 DRAFT GUIDANCE Sanitizers and Decontamination for RTE Food Plants Table 1. Properties of Chemical Sanitizers

Ozone Carboxylic Acid Iodine Compounds (fatty acid) (Iodophors) Germicidal Action Bacteria, viruses, fungi Bacteria, virus, fungi. Bacteria, fungi, virus- including parasite and May inactivate spores es, and some para- bacterial spores at high at high concentrations sites, not recommend- concentrations ed for spore control General uses Area fumigation and Surfaces, processing Surface and utensil surface disinfectant (liq- equipment and utensils disinfectant, brewery, uid), approved for use on dairy and food pro- organic foods (USDA Nat’l cessing equipment. Organic Program) Floors and walls at 68 – 100 ppm Form Gas or liquid liquid liquid General use dilution 0.2 – 3.0 ppm 39 ppm (no rinse appli- 12.5 – 25 ppm (no cation) 70 – 1500 ppm rinse application) pH Not applicable 3.5 - 4.0 3.0 Temperature Stable at low temperature May lose efficacy below Minimum temperature (86oF and below) 50oF 75oF

Maximum 120oF Corrosion Slight to moderate, more Slight Slight to moderate, corrosive at sporicidal depending on concen- concentration tration Stability Low Yes Moderate (use dilution) Toxicity (use dilution) Possible Minimal No Irritant (use dilution) Yes (oxidizer) Low No Vapors (working con- Yes No No centration) Penetration Yes No No Hard Water Minimal effect Minimal effect Minimal effect Organic soil toler- Marked loss of efficacy in Good Some loss of efficacy ance presence of organic soils in presence of organic soils Residual biocide None Minimal Moderate activity after use Advantages Environmental friendly, fast Relatively non-corro- Relatively non-corro- acting, treatment recog- sive, FDA approved for sive, FDA approved nized as organic no rinse use (39 ppm). for no rinse use at Low foaming depending 25 ppm, little envi- on wetting agent, stable ronmental concerns at high temperature (Docket number EPA- HQ-OPP-2006-0599) Disadvantages Must be produced on site, May corrode some met- Requires low pH (< expense of ozone generat- als and plastics 3.0) for activity, can ing equipment stain materials, not effective on spores

13 DRAFT GUIDANCE Sanitizers and Decontamination for RTE Food Plants Table 1. Properties of Chemical Sanitizers

Quaternary Acid Anionics Peracetic Acid Ammonium Com- (Organic acid plus (with hydrogen pounds wetting agent) peroxide) Germicidal Action Bacteria (especially L. Bacteria, virus, fungi. Bacteria, virus, fungi. monocytogenes, less effec- Ineffective against some May inactivate spores tive against Gram nega- food spoilage organisms at high concentra- tive), molds. Not for use tions. EPA approved against spores for anthrax spores General uses food contact surfaces, Food processing equip- Food and dairy pro- floors, drains ment and utensils cessing equipment, utensils, and poultry carcass rinse Form Odorless, colorless liquid liquid Liquid General use dilution 200 ppm (no rinse) 400 ppm (30 ppm no 315 ppm rinse) pH Broad range activity 2.0 – 3.0 Broad range activity Temperature Broad Range Broad Range Works well at low temperatures Corrosion None at 200 ppm Some metals May effect galvanized steel Stability Good Good Good (use dilution) Toxicity None Low Low (use dilution) Irritant (use dilution) None Low Yes, strong oxidizer Vapors (working None Yes Yes concentration) Penetration Good for porous surfaces Good Good Hard Water Decreased efficacy in hard Decreased efficacy in Minimal effect water hard water Organic soil toler- Good Good Good ance Residual biocide Yes Minimal Minimal activity after use Advantages Relatively non-corrosive, Good for CIP in May be used in CIP, FDA approved for no rinse combination with low EPA registered as use (200 ppm). Safe for foaming wetting agent. a no rinse sanitizer. use as environmental Effective against sanitizer at 1,000 ppm. biofilms, works well Effective against biofilms. at low temperatures, approved for use on organic foods Disadvantages E. coli, Pseudomonas, other Relatively expensive, Expense, not effective Gram negative bacteria, may cause foaming against some molds and spoilage organisms depending on wetting and yeast, requires can be resistant at 200 agent, strict low pH precise mixing with

ppm. range for activity. H2O2

14 DRAFT GUIDANCE Sanitizers and Decontamination for RTE Food Plants

Table 2. Sanitizer Effectiveness and Compatibility

Cleanser/ Common Form Effectiveness Compatibility* Sanitizer Peracetic Acid (PAA) Colorless liquid Effective against all bacteria, Compatible with with “vinegar” viruses and fungi. Effective stainless steel and most odor. Breaks down against spores at high (1000 other metals, neoprene into water, oxygen ppm or more) concentra- & butyl rubber, ceramic and acetic acid. tions. CIP compatible since and glass. Do not use on Corrosive to skin it is non-foaming. Environ- brass, nickel, aluminum, and mucous mem- mentally friendly, GRAS iron, copper, galvanized branes, proper rated, FDA approved for metal or polyurethane PPE required. direct food contact and (150 – 200 ppm) food contact surfaces. Can be used in non-rinse procedures Hydrogen Peroxide Colorless liquid. Effective against all bac- Compatible

H2O2 Breaks down into teria, viruses and fungi. with stainless steel, water and oxy- Effective against spores at aluminum, bronze, cast (liquid) gen. Corrosive to high (25-60%) concentra- iron, PVC, natural rubber, skin and mucous tions. EPA approved for ceramic, polycarbonate membranes at treatment of food and and polypropylene. Do high concentra- non-food crops, fruits and not use on brass, copper,

tions, proper PPE vegetables. 35% H2O2 FDA neoprene, carbon steel, required approved for sterilization of or nitrile food packaging and containers (21CFR178.1005), approved for use on organic foods (USDA Na- tional Organic Program) Environmentally friendly

Hydrogen Peroxide Vaporous H2O2 is Effective against all Compatible with stain- H2O2 produced from liq- bacteria, viruses and fungi. less steel, aluminum, uid H2O2 (30-50%) Effective against spores at bronze, cast iron, PVC, (gas) by “flash vaporiza- high concentrations (500 natural rubber, ceramic, tion” ppm). Can deactivate certain glass, polycarbonate toxins and chemicals and polypropylene. Do not use on nylon, cop- Environmentally friendly, per, brass, neoprene, decomposes to water & carbon steel, or nitrile. oxygen Low temperature allows sterilization of electrical equipment. (EPA tested compatible with DVD & CD discs, cell phones, fax & copier machines, copper & aluminum electrical sockets.)

*This information is presented as a guideline only. Compatibility depends on many factors including pH, temperature and concentration. Consult a specialist to determine the exact conditions of your sanitizer and its compatibility to your facility.

15 DRAFT GUIDANCE Sanitizers and Decontamination for RTE Food Plants

Table 2. Sanitizer Effectiveness and Compatibility

Cleanser/Sanitizer Common Form Effectiveness Compatibility* Chlorine Dioxide Typically used at Effective against all bacteria, vi- Compatible with

ClO2 200-500 ppm ruses and fungi. Effective against aluminum, ceramic, spores at higher concentrations. PTFE (Teflon). Do Liquid EPA approved for use on anthrax not use on cast iron, spores at 500 ppm neoprene, polypropylene, 316 stainless steel, polyurethane, nitrile, polyethylene, natural rubber Chlorine Dioxide Typically used at Effective against all bacteria, vi- Little evidence

ClO2 0.5 to 30 ppm ruses and fungi. Effective against of corrosion at spores at higher concentrations. sanitation levels Gas EPA approved for use on anthrax (0.5 - 30 ppm). EPA spores (750 ppm, 12 hr exposure) tests show corrosion on computers and electrical wiring at 750 ppm, 12 hr exposure Formaldehyde Clear colorless Effective against all bacteria, vi- Compatible with liquid, with pun- ruses and fungi. Effective against stainless steel, gent odor. Mis- spores at higher concentrations. aluminum, brass, cible in water bronze, copper, cast Not environmentally friendly. iron, nitrile, ceramic, Listed as OSHA “select carcino- natural rubber, gen”. Requires special storage neoprene, polypro- and disposal methods due to pylene, PVC. Do not carcinogenicity and flammability use on carbon steel Ethylene Oxide Gas (400 – 1200 Effective against all bacteria, Compatible with ppm sterilization viruses and fungi and spores. Not stainless steel, concentration), environmentally friendly. Listed nylon, Do not use on sometimes mixed as OSHA “select carcinogen”. aluminum, brass, with nitrogen or Not used for area fumigation, cast iron, copper, ni- carbon dioxide. enclosed chamber use is most trile, natural rubber, common. EPA approved for use neoprene, polypro- on anthrax spores pylene, PVC, silicone Chlorine (bleach) Liquid (200 ppm is Effective against all bacteria, Compatible with maximum for no viruses and fungi, and parasites stainless steel, PVC, rinse application) at higher concentrations. EPA ap- aluminum. Do not proved for anthrax treatment at use on polyure- 5,000 – 6,000 ppm thane, natural rubber, nitrile, carbon steel, cast iron

16 DRAFT GUIDANCE Sanitizers and Decontamination for RTE Food Plants

Table 2. Sanitizer Effectiveness and Compatibility

Cleanser/ Common Form Effectiveness Compatibility* Sanitizer Chloramines Colorless liquid Effective against most bacteria, Generally non viruses, mold and fungi. corrosive at use (Chloramine T) concentrations. Mainly used in water purification Will degrade nitrile and other type materials. Ozone Gas (0.2 to 10.0 Effective against all bacteria, Compatible with ppm). Can be viruses and fungi. Effective against stainless steel, added to distilled spores and parasites at higher polyurethane. water for use as concentrations and more corrosive Slight corrosion on an aqueous disin- at these concentrations. Environ- aluminum, brass, fectant mentally friendly (by products are bronze, PVC Do water and oxygen), Use on food is not use on nitrile, FDA approved neoprene, natural rubber Iodophors Liquid (12.5 – 25 Effective against bacteria, viruses, Compatible with ppm for no rinse mold and fungi. Not effective PVC, most metals, applications; 68 – against bacterial spores polypropylene, 100 ppm for floors Slight corrosion and walls) on aluminum and bronze. Do not use on silicone. Will stain plastics, cloth and surfaces Quaternary Odorless, color- Effective against most bacteria, Relatively non Ammonium Com- less liquid (200 some viruses, mold and fungi. Poor corrosive to most pounds ppm for no rinse activity against E. coli and spoilage surfaces, depend- applications; 400 bacteria at 200 ppm. Not effective ing on formula- – 1,000 ppm for against spores tion. Some may be floors and walls) corrosive to certain metals Citric Acid Colorless liquid Effective against virus, fungi and Compatible with bacteria at 2.5 to 8% concentra- stainless steel, tions. Environmentally friendly, natural rubber, FDA listed as GRAS, approved for nitrile, neoprene, use on organic foods (USDA Na- PVC, Do not use on tional Organic Program) aluminum, carbon steel, cast iron, copper Acid Anionics Liquid Bacteria, virus, fungi. Not recom- Compatible with mended for spores stainless steel but may be corrosive to other metals. Carboxylic Acid Liquid Bacteria, virus, fungi. Not recom- Compatible with (fatty acid) mended for spores stainless steel but may be corrosive to other metals, plastics and rubber. 17 DRAFT GUIDANCE Sanitizers and Decontamination for RTE Food Plants

Notes

18 DRAFT GUIDANCE Sanitizers and Decontamination for RTE Food Plants

Notes

19 DRAFT GUIDANCE Sanitizers and Decontamination for RTE Food Plants

Notes

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20 DRAFT GUIDANCE INNOVATIVE FOOD DEFENSE PROGRAM 8

Decontamination Analysis and Verification

After cleaning and sanitation of the contaminated How Do these Documents Relate to the FDA GMPs area, verifying that the area and equipment and Other Regulations? have been successfully sanitized is required before production can resume. Decontamination These documents are not meant to supersede verification is part of the overall remediation any FDA or USDA guidelines, requirements strategy and therefore a detailed plan should or recommendations. The guidance and be designed and in place before cleaning and recommendations in this and all accompanying sanitation begins. Doubtless plans will be documents are meant to compliment those of modified as work progresses however; all steps current GMPs and the newly adopted Food Safety must be verified and any changes approved Modernization Act. Any regulations currently by local, state, and federal officials. Close required by FDA or USDA must be followed. communication with regulatory officials should expedite approvals to resume production. Methods of Decontamination Verification There are a number of verification procedures Visual Inspection – While visual inspection cannot be available to facility managers to choose from. You the sole verification method, it is a very important, must keep in mind the use of a procedure and/or quick first step to help verify whether the cleaning sampling tools must be validated that it will work process was adequate. A well trained inspector or effectively in your facility. In other words, there quality control analyst with a good flashlight will is certification that the method will function as be able to detect residue in equipment corners, intended to give reliable results. Certification can weld joints, bolt or screw heads and threads, pipe be from FDA, USDA, EPA, AOAC International, connections, door jams, floors, and a whole host AFDO or other regulatory bodies and should be of other areas. This inspection will be required supplied by the manufacturer of the method(s) before the decontamination process takes place. and their applications. ATP Bioluminescence – ATP bioluminescence is a procedure that has been available for 20- Who Should Follow The Guidance in these 30 years. ATP (adenosine triphosphate) is a Documents? compound found in all organisms, body fluids Decontamination verification is just one part of (i.e., blood), food, and other organic matter. the remediation strategy plan and is ultimately Bioluminescence could be considered an adjunct the responsibility of the owner(s) of RTE-food to visual inspection since even after thorough processing facilities. Facility managers, quality cleaning, residue can persist on equipment and assurance and quality control personnel should surfaces that is not visible to the naked eye. A initiate and develop these plans and would swab is used to collect a sample from a surface, benefit by following the guidance documents in placed in a hand held apparatus and the ATP is this series. Facility supervision personnel should converted to a light signal measured in minutes. provide training sessions for all employees in the A strong light signal indicates residue is present implementation of preventative and remediation on the surface and cleaning was not adequate. plans adopted. It is our hope that all RTE-foods This is not a direct measurement of bacteria but processors will benefit from following these a measurement of organic matter containing recommendations to help avoid the product ATP. Technological developments are moving contamination/plant closure scenario. towards sensitivities that will allow this procedure to measure only bacterial ATP but at the present time bioluminescence is generally considered to be an indicator of adequate cleaning and good hygiene. DRAFT GUIDANCE Decontamination Analysis and Verification

The advantage of this is method is that results Zone 1: Zone 1 refers to all direct food contact are collected very quickly. On the other hand, surfaces such as slicers, mixers, conveyors, the method is a qualitative test, not quantitative, utensils, racks, work tables and any pipes or and the operator should be aware of this. Certain electrical conduit that may be above food contact cleanser and/or sanitizer residue may adversely areas. (Direct food contact surfaces prior to the affect the accuracy of the assay. Different surface cooking, or “kill-step” point in the processing structures or compositions will also affect the protocol should not be considered zone 1.) accuracy. There are also several brands of bioluminescence tests that measure protein Zone 2: Zone 2 encompasses the areas directly deposited on surfaces. This analysis can be useful adjacent to food contact surfaces (zone 1). These in facilities where flours and grains are used. are areas where environmental contamination is most likely to directly affect safety of the Environmental (Sponge and Swab) Sampling – product. Zone 2 encompasses all non-food Sponge and swab sampling are likely the most contact surfaces in the processing area, such common form of decontamination verification. as the exterior of equipment, chairs, step stools, They are used to collect and detect bacterial equipment framework, food carts, equipment cells, spores, and viruses from all surfaces in housing, gears, ventilation and air handling a facility. Swabs are generally made of cotton, equipment, and floors. Floor mats and anti-fatigue polyester, polyurethane, nylon or alginate and rugs often harbor contaminants and should not be spun onto a wooden or plastic stick. Sponges are overlooked during the sampling process. In large generally made of cellulose and may be attached areas, (e.g. 20,000 square feet) zone 2 is the area to a plastic applicator if desired. Swabs are around the exposed product in which you could purchased sterilized and in tubes with or without envision a pathway to product contamination liquid carrying buffer. Carrying buffer is a liquid either through the actions of man or machine; for medium which protects the microorganisms example, even a far corner of the room could be during transit to the laboratory. considered zone 2 if foot traffic or forklifts move Sterile sponges are packaged in plastic through that area and these traffic patterns bags pre-moistened with liquid carrying buffer or also go very near a line where exposed food is dry, the carrying buffer added to the dry sponge conveyed or held, or ventilation patterns cause before sample collection. Sponges are preferred airflow from these remote areas. over swabs since more pressure can be applied to the sample area, thereby having a greater Zone 3: Zone 3 surrounds zone 2 and is an area chance of dislodging cells adhering to surfaces which, if contaminated with a pathogen, could or in biofilms. Swabs should only be used to lead to contamination of zone 2 via actions of sample small cracks and crevices. Once the humans or movement of machinery. Examples sample is aseptically collected, the swab/sponge of zone 3 areas include corridors and doorways is placed back into its container and sent to a lab leading into food production areas or areas in to determine presence or absence of bacteria. a large production room that are further away Normally, the samples are examined for the from food handling equipment than typical zone presence/absence of microbial pathogens, but 2 areas. This could include walls, phones and fire in some cases they may be used to quantitatively extinguishers. Brooms, squeegees, mops, floor determine bacterial load on a surface, usually scrubbers, forklifts and hand trucks, while stored total bacterial counts, coliform counts, or E. coli in zone 3 areas could easily be considered zone counts. Extreme care must be taken in evaluating 2 if used close to direct food contact areas and this type of data since 100% recovery cannot be should not be overlooked during the sampling achieved and sampling effectiveness can be process. Likewise, wheels on any equipment in below 50% of total microorganisms on the surface, zone 3 should be sampled if they are used close to direct food contact areas. depending on the sampling method and type of surface being sampled. Zone 4: Zone 4 is an area which, if contaminated The inspection/investigation team will with a pathogen, could lead to contamination of conduct a walkthrough examination of the area(s) zone 3 via the actions of humans or machinery, to be tested prior to environmental sampling but is almost always prior to the cooking or “kill- to determine the locations to sample and the step” point in the production process. Examples number of samples to be taken. Specific areas of zone 4 areas include an employee locker room of any food processing facility to be analyzed by if not immediately adjacent to food production environmental sampling are normally divided into rooms, dry goods storage warehouse, cafeterias, “zones”, which indicates the level of importance hallways, and loading dock area. of the samples. 2 DRAFT GUIDANCE Decontamination Analysis and Verification

Contact Plates - There are several variations of medium which can inhibit the growth of the the contact plate method but all employ the collected microorganisms. process of placing a plate or applicator filled with solid growth medium in direct contact with a flat Sedimentation is the process where solid agar growth medium in a plate (or hydrated surface, pressing slightly to get good contact, and TM then incubating the plate/applicator and counting Petrifilm ) is placed on a surface and airborne total colony forming units (CFU) per applicator (a microorganisms are allowed to settle onto the measure of the number of microorganisms on the surface by gravity over a certain period of time. surface). The growth medium used can be selected The drawback of this method is that there is no to recover aerobic bacteria, yeast and fungi, way to measure the amount of air being sampled. or can be selective for coliforms or pathogens. Gelatin membrane filtration may be the most Common methods are hydrated PetrifilmTM (3M), efficient method of microbial air sampling in that RODACTM plates, and agar slides. In theory this all air entering the sampler must pass through the method can be used as a quantitative analysis of gelatin filter, eliminating the blow by experienced microbial counts on any flat surface of processing with impaction. The gelatin filter is highly equipment and other food contact surfaces, as hydrated which nearly eliminates the problems well as environmental surfaces such as floors, of growth medium dehydration and the small walls, bins, and transport equipment. As above, pore size of the filter insures collection of small care must be taken in evaluating this type of data particles which would be missed by impaction. since 100% recovery of microorganisms cannot Once air collection is complete, the gelatin filter be achieved and sampling effectiveness can be is removed from the sampler and placed on a below 50% depending on the sampling method plate filled with solid agar growth medium and and type of surface ( e.g., steel, glass, rubber, incubated the same as a contact plate. Colony polyethylene, porous, nonporous) being sampled. forming units per plate are counted which relates Also, residual cleansers and sanitizers will affect to the air volume collected in the sampling microbial recovery. Consult with all regulatory process. Recent improvements in the technology officials before proceeding with these methods. of the gelatin membrane filtration method allow a precise measurement of airborne bacteria in a Air Sampling – Airborne contamination of product variety of environments and applications. is always been a concern during the normal operation of food processing plants. Good Biological Indicators – Biological indicators are Manufacturing Practices (GMP) Section 110.20 normally used to verify the effectiveness of steam Part(6) states the facility shall “provide adequate sterilization but are can also be used to verify ventilation or control equipment to minimize odors decontamination using gas or vapor phase and vapors (including steam and noxious fumes) sterilizing agents such as chlorine dioxide, in areas where they may contaminate food; and hydrogen peroxide, and ozone. The indicator locate and operate fans and other air-blowing consists of a strip impregnated with viable spores equipment in a manner that minimizes the and a vial of growth medium all placed in a plastic potential for contaminating food, food-packing vial permeable to the sterilant. Vials of growth materials and food contact surfaces.” Control of medium and treated strip are placed in specific airborne contamination is especially important locations in the decontamination area and then due to the heightened generation of dust and placed in an incubator (after the growth medium aerosols throughout the remediation process. is released) after decontamination. No growth in the vial verifies successful decontamination. There are several methods of air sampling and Their use is limited in that they can only be used in the selection of the most effective technique is enclosed areas where gas/vapor decontamination determined by the type of facility and remediation is feasible, but as the cost of gas/vapor generators process. drops they will become more common. An Impaction is a process whereby air is drawn by advantage of these indicators is that they are vacuum into a mechanical collector and impacts used during the decontamination process; but onto the surface of a plate filled with solid agar it still requires an incubation period of 2-7 days growth medium. After a certain concentration of to complete the verification. They have also been air has been collected the growth medium plate used to verify decontamination by radiation. is incubated and bacteria are counted. Small particles may not impact onto the agar surface which will reduce the efficiency of the sampling. Also, the flow of air can dehydrate the growth 3 DRAFT GUIDANCE Decontamination Analysis and Verification

Finished Product Testing – Finished product testing Definitions will routinely be required after the cleaning and sanitizing procedures have been verified Aseptic sampling – or asepsis; the process and accepted by regulatory officials. Sample of collecting samples where no outside selection and sample sizes must be carefully contamination (i.e., from sampler’s hands) can determined to ensure a meaningful, statistically occur relevant collection is tested. Sample type and Biofilm – a mucilaginous film built by bacteria size should be resolved as part of the initial on surfaces that resists cleaning and sanitizing. remediation strategy and receive approval from Dental plaque and sludge covering the interior of regulatory officials. One should keep in mind that drain pipes are good examples. obtaining a statistically relevant sample collection from any lot for which you can be confident Agar growth medium – A solid growth medium that that lot is not contaminated is extremely for the growth of microorganisms whereby cells difficult, if not impossible. This is why cleaning/ can grow to colonies, visible to the naked eye for decontamination verification and environmental counting. sampling are so vital to the remediation process CFU- Colony forming units. A measure of living prior to production restoration. microorganisms in a sample. The sample It is vitally important that the members of the is placed on agar growth medium and after remediation team realize that decontamination incubation the microorganisms grow to colonies verification is the most important aspect of the visible to the naked eye. restoration process and that all verification Qualitative analysis – Measurements whereby methods have limitations as described above. the presence of absence of microorganisms or It may be necessary to develop unconventional other contamination are present. decontamination methods for a specific food production process. This will require innovative Quantitative analysis - Measurements whereby decontamination verification methods, always be the number of microorganisms or concentration based on sound science and meet the approval of of other contaminants are determined. all local, state, and federal officials. Spores – a non-growing, but viable form of a microorganism’s life cycle. Similar to plant seeds, a spore resists unfavorable conditions (lack of water or nutrients) and will germinate when favorable conditions are presented.

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4 DRAFT GUIDANCE INNOVATIVE FOOD DEFENSE PROGRAM 9

Facility Characterization, Site Containment and Preparation

Once a contamination incident has been found, it • Erection of roofs, if necessary, to further is vital that the area of contamination be identified isolate the area and eliminate the and isolated as soon as possible. For small possibility of dust or organic material from facilities, this might mean shutting down the entire entering or exiting the contaminated area production area; for larger facilities this means isolating the contaminated area and restricting • Establishment of specific entry and exit traffic in this area from non-affected locations in points to the contaminated area, with the plant. proper decontamination controls such as disinfectant hand wash stations, foot Who Should Follow The Guidance in these baths, and any PPE that may be required Documents? before entering the contaminated area. A personnel monitor should be assigned to Facility characterization and site preparation is each entrance/exit point to assure that all just one part of the remediation strategy plan and workers are following the specific rules of is ultimately the responsibility of the owner(s) of restricted access to the area. RTE-food processing facilities. Facility managers, quality assurance and quality control personnel • Institute a training program to establish should initiate and develop these plans and would sanitary guidelines for all persons benefit by following the guidance documents in expected to enter the contaminated this series. Facility supervision personnel should area and insure that these guidelines provide training sessions for all employees in the are followed. This includes any outside implementation of preventative and remediation contractors required. plans adopted. It is our hope that all RTE-foods • Establish a team to work with local, processors will benefit from following these state, and federal officials to insure that recommendations to help avoid the product all remediation and decontamination contamination/plant closure scenario. verification procedures developed are accepted and approved by How Do these Documents Relate to the FDA these organizations. Document all GMPs and Other Regulations? decontamination and remediation These documents are not meant to supersede procedures on a daily basis to insure that any FDA or USDA guidelines, requirements these procedures are being followed to the or recommendations. The guidance and expressed approval of these officials. recommendations in this and all accompanying • Assign a person or persons as the documents are meant to compliment those of communication executive(s) to inform current GMPs and the newly adopted Food Safety employees at the facility of the restoration Modernization Act. Any regulations currently work required, the expected time required required by FDA or USDA must be followed. to complete the process, and the areas The first steps of isolation, containment, and that are under restricted access. These restoration should be: individuals may be required to deal with the media, public, and regulatory officials • Erection of temporary walls surrounding as to the daily progress of the restoration the contaminated area, using lumber process or metal covered with plastic sheeting, tarps or other components to eliminate air • Ideally, all tools and equipment required flow from the contaminated area to non- for restoration should be sanitized before contaminated areas. entering the containment area and left DRAFT GUIDANCE Facility Characterization, Site Containment and Preparation

in the area as dedicated tools for the • Once remediation is complete, consult with duration of the remediation process. If local, state and federal officials to confirm this is not possible, a procedure to sanitize that the restoration and decontamination tools and equipment before entry must be procedures meet all regulatory constituted and followed by all employees, requirements before starting normal including outside contractors, and verified processing procedures by the personnel monitor(s). • Monitor the area outside of the containment area daily to assure that no failure in containment has occurred. This may be accomplished by air sampling and physical observation of the containment walls, roof, and surrounding floor for breaches in the isolation system. • Establish a specific area of storage for all equipment, chemicals, cleansers, and sanitizers directly related to the remediation process and limit access of this area to individuals directly involved in the remediation process. This may require the rental of storage containment containers. • Establish a designated area for all equipment that will be removed from the contaminated area for cleaning and sanitizing. This area must be isolated from the normal clean out of place areas of normal facility operation if other areas are still producing product. • Establish a designated storage area for all waste materials coming from the contaminated area, limiting access only to those directly related to the remediation process. • Construct a waste disposal plan that meets with all local, state and federal regulations

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2 DRAFT GUIDANCE INNOVATIVE FOOD DEFENSE PROGRAM 10

Contaminated Waste Disposal

Introduction 3. When – The urgency of decisions for waste If a food processing facility, its production system related questions and activities will be or final product has been contaminated by determined by the hazards which they microorganisms, materials that are or suspected pose, their stability, their quantities, and the to have been contaminated during processing, influence they have on the overall response cleaning, disinfection, or recovery operations must objectives. be handled, transported, and disposed of in a 4. Where – During a contamination event safe and regulatory acceptable manner. Effective response there will likely be numerous implementation of these disposal activities is locations and processes from which critical to a successful food contamination event waste materials are generated, methods response. This document provides considerations by which the will need to be packaged or and recommendations for accomplishing those processed, transportation and destinations objectives. to which they will need to be delivered. All Event Approach of these locations and routes will need to The approach used is based on the classic be identified, classified, and appropriately response questions of who, what, when, where, protected. why, and how. Disposal of affected materials 5. Why – The principle reasons why proper should be determined immediately following disposal is so critical in a contamination event identification and containment. response event are prevention of spread 1. Who – In any food contamination event of the contaminant, elimination of further the “Who” is likely a broad collection of human or animal exposure, and facilitation individuals agencies and organizations. of effective clean-up and return to safe food Who is requiring action in response to a production. contamination event? Who is defining 6. How – The methods, agents, and the response methods to be followed in individuals carrying out an effective addressing the contamination? Who contamination event response will be is determining the criteria to which a determined as the event is identified and successful response is measured? Who is the clearance goals defined. Critical carrying out the response activity? Who is factors in this determination include what evaluating progress toward the objective is contaminated, what is the contaminant, criteria? And, most important, who is what are effective decontamination paying the bills for the response? strategies, how much contamination These broad questions would be focused is suspected, what are the hazards to down to the specifics of each disposal humans and animals, and what funding is activity. available. 2. What – In the characterization of the Response Considerations contamination event, the type and nature 1. In the early stages of a suspected food of waste hazard(s) will need to be identified contamination event there are usually and defined in order to plan for safe and a significant number of unknowns proper collection, processing, containment, regarding characterization, resources, packaging, and disposal. and response. At this point it is critical to identify potentially contaminated equipment and materials and quarantine DRAFT GUIDANCE Contaminated Waste Disposal

or isolate them until clearer information is b. Materials that are determined available regarding what actually needs to be or suspected of containing to be addressed. During this period pathogens hazardous to humans or no disposal activity should take place, animals are much more limited in unless failure to do so would create a approved disposal methods. These greater risk to humans, animals or the items either must be preprocessed to environment. An example of this situation remove or neutralize the pathogens would be suspected contamination at a in an approved manner, or they will meat packing plant. In such an event the have to be disposed of by incineration, appropriate options might be to refrigerate gasification, other approved chemical or freeze the suspected meat products in or oxidation method. an isolated location away from personnel and non-impacted product. By-products c. Preprocessing might include that could not be safely refrigerated/frozen cooking, pH alteration, irradiation, or should be sent for thermal destruction or ultraviolet (UV) exposure. alkaline hydrolysis. d. If highly infectious contamination is 2. As the event response is better defined identified or suspected, then the entire and organized, each potential waste disposal process as well as the event stream must be identified, characterized, response moves to a higher protection and provided with a detailed disposal level for personnel, animals and the procedure. A procedure must also be environment. The available resources implemented for tracking and verifying and qualified response personnel the accomplishment of each step of these are reduced significantly. In the case procedures for every waste stream. of highly hazardous contamination events, facility or process recovery 3. Critical information in every waste stream strategy may be replaced by disposal activity will include the following: containment and destruction of the facility or the affected portion thereof. a. Who must approve the procedure? b. Who will carry out the required 5. Timing often influences event disposal procedure? strategy because the longer it takes to c. What would be the potential dispose of contaminated materials, the hazards? more difficult and expensive the process d. What special precautions will be becomes. The earlier that hazards can required? be safely addressed, the smaller the size e. How will these hazards be of the impacted area, the less impact on mitigated? material and equipment, the smaller the f. How will the waste be prepared response effort required, and potentially and packaged? the lower the cost of the response. g. Will preliminary decontamination be required, if so, how? 6. Technology also can influence the h. How will it be transported, by disposal effort. Once the waste stream whom, and to where? is characterized then the best disposal i. Is this an interim storage of the method can be identified. Continuous waste material? For how long? technology improvements have created j. What documentation will be very effective ways for processing and required? disposing of contaminated materials. The k. Who is responsible for the waste problem with new technology is often the material during each step? finite amount available, the scarcity of qualified providers, and the high cost of 4. Characterization of each potential waste using it. material will be critical in determining the method and procedure for its disposal. 7. Perhaps the most significant consideration in any contamination event disposal a. Non-hazardous material can be response is cost. If the cost of containing, handled in accordance with normal cleaning, decontaminating, and restoring facility waste disposal guidelines and a food processing or production exceeds existing waste processing facilities. the profitability of the potential product 2 DRAFT GUIDANCE Contaminated Waste Disposal

market, the response effort may be limited amount of biological that they can to the minimal clean-up effort required receive and the geographical area that by statute, law or regulation. Other cost they are permitted to serve considerations that influence this decision include product acceptance, interim and i. MSWLF’s may choose what and long-term lost revenues, lost workforce, how much waste material that they regulatory fines and penalties, and are willing to take and the cost to take required process upgrades. In the specific it, or they may refuse to take a waste area of disposal there is the financial material at all consideration of long-term liability for the j. Shipment of biological material disposal method chose. The originator of a to a MSWLF requires biosecure waste material retains responsibility for the transportation, prior notice to and disposed material virtually forever. approval by the MSWLF, an open excavation to receive the waste, and Disposal Methods immediate covering by the MSWLF to The technologies that currently offer promise prevent access by birds or vermin in providing major time-of-emergency disposal include: k. MSWLF’s are not designed to promote disease destruction or 1. Burial complete material decomposition Burial is the primary disposal method because of leachate collection and for most food related contamination processing requirements event response efforts because it is fairly simple, readily available, and economical. l. MSWLF’s generally provide dry Problems with burial: entombment of materials a. Most food processing facilities do not have the property to allow the m. Burial tends to move a onsite burial of significant amounts of contamination out of site. waste material and most zoning laws In North Carolina the most common would not permit it access to burial is through the Solid b. Wet or freezing weather or a Waste authority in each county shallow water table may prevent burial government. These organizations will be aware of the facilities available and c. Proximate surface water may the contacts. prevent burial 2. Composting d. Burial of improperly sterilized Composting is the combination of material may contaminate ground waste material in a precise recipe of water and spread disease waste, carbon source, moisture and air stimulating oxidation which breaks down e. Burial on private property may the waste and destroys many pathogens. require notation on the property deed The process will not destroy prions (a and may negatively influence real protein particle thought to be the agent estate values in the area responsible for Mad Cow Disease) or f. Burial on processing plant neutralize chemical contamination. may negatively influence return to Composting is actually processing waste normal production, especially with materials for subsequent use as a fertilizer international markets or mulch, compression into a fuel material, or disposal by burial. Advantages of g. Any contaminated material known composting include: or suspected of containing pathogens hazardous to humans or animals a. Composting can be done onsite, cannot be disposed of in a municipal offsite, or a combination thereof solid waste landfill (MSWLF). If the b. It is fairly simple material is preprocessed to destroy or c. It is a fairly inexpensive process neutralize the pathogens, the landfill d. It can destroy many common may accept the material disease pathogens e. It can be mechanized h. MSWLF’s are limited on the 3 DRAFT GUIDANCE Contaminated Waste Disposal

f. It can produce a useful by-product. a. In North Carolina it offers an existing infrastructure with a known 3. Problems associated with composting are processing capacity similar to burial with some additions: b. Service can include collection a. Although initial pathogen kill by containers, transportation, and composting may be accomplished biosecurity program in a few days or weeks, the complete processes takes several months c. The industry has a good understanding of biosecurity and b. On-site composting requires either pathogen destruction capabilities space in the production structures or significant property commitment d. Rendering process provides a 65% reduction in material mass c. Composting requires a moderate labor commitment over a long period e. Process produces marketable byproducts d. Mechanized composting will require a moderate financial f. Mobile rendering technology is commitment up front available, but has not yet arrived in the US. e. Local zoning may prohibit composting operations at a particular Problems associated with rendering may facility or location include: a. Facilities are fixed, requiring f. It is difficult to certify a facility material to be transported to them free from a pathogen that is being processed on the site b. The processing capacity is fixed and additional processing is subject g. On-site composting may delay to the amount of normal production the return of the facility to normal business to which a given is committed production or the marketability of product. c. Some facilities restrict the type of animal material that they will Although composting is carried out at a process based on the ultimate use or few MSWLF facilities in North Carolina, destination of their oil or meal the majority of the composting facilities are private. One such company is McGill d. introduction of certain pathogens Environmental Systems, PO Box 61, may influence its return to normal Harrells, NC, 28444, telephone 910-532- production or the marketing of its 2539. products

3. Rendering e. Processing capacity of a rendering Rendering is a process which produces plant is directly influenced by its waste products that can be reused for another water discharge and air permits and purpose or can safely buried. Typical RTE- the local landfill receipt capacity for food production facilities may not need this biological materials process, however, small custom f. Construction of new rendering butchering shops may find this option plants requires years. useful in response to a remeditation event. Animal carcass and production There are several rendering companies byproducts are ground and heated to a across North Carolina. One of the larger specific temperature for a finite time to organizations is Valley Proteins, Inc. based kill pathogens in order to allow use of the in Winchester, VA at telephone number resulting oils and meals for food, feed, 800/871-3406. and fuel production. The use of rendering 4. Incineration is subject to there being a rendering Incineration is the thermal destruction company within a reasonable distance to of materials by open or trench burn, the facility producing the animal materials. portable burn box, portable incinerator, Benefits of rendering include: industrial furnace, or fixed commercial

4 DRAFT GUIDANCE Contaminated Waste Disposal

waste incinerator facility. In the absence h. Volume of waste material and of an emergency declaration all of these temperature required will influence incinerators would have some level of the type equipment for required the EPA air quality regulation. Advantages of job. incineration include: The availability of contract incineration at a. Incineration may be local or fixed facilities in North Carolina is rare, but portable several contractors serving the state do provide incineration services by hauling b. Fairly straight forward process outside of the State. One such contractor c. High temperature destroys is Clean Harbors Environmental Services, pathogens Reidsville, NC, telephone number 336-342- 6106. d. Good containment when properly carried out 5. Gasification Gasification is enclosed incineration which e. Little risk of further contamination limits the amount of air in the combustion f. Byproduct is a fertilizer or asphalt chamber; thereby reducing the emission additive contaminants and smoke. Benefits of the gasifier technology include: g. Moderate production potential a. May be local, portable, or fixed h. Controllable process facility i. Box burners can handle up to b. Provides high temper destruction of 100,000 lbs/day of mass and solid pathogens including prions fuel c. Good containment and low j. Will destroy prions when properly emissions done d. Little further processing of or risk k. Provides greater than 95% mass from resulting material reduction. e. Waste product is the fuel, feed, or Potential problems with incineration: fertilizer additive a. Public opinion may be negative, f. Moderate production capability especially in highly visible locations g. Controllable Process b. Transportation and process h. Mass reduction greater than 95% biosecurity must be watched i. Possible secondary production of closely synthetic fuel, electricity, hot water, c. Visible smoke and ash draw or steam attention of public Potential problems with gasification d. Fuel requirement may be greater include: than the contaminated mass being a. Limited availability disposed of b. Preprocessing (maceration) e. Suitable site selection may be required for most effective disposal difficult c. Biosecurity must be closely f. In a multi-site event, incineration monitored of materials may require special d. Moderate cost involved exemption to EPA regulations to move contaminated material Gasification is very limited throughout the between sites country but there is a small equipment supplier in North Carolina that handles g. Fire and thermal burn safety are units up to about 1,200 pounds per cycle. critical They are Biomass Marketing Associates at telephone 252/826-4800. 5 DRAFT GUIDANCE Contaminated Waste Disposal

6. Alkaline Hydrolysis c. Daily capacity of mobile unit Alkaline hydrolysis is waste processing approaching 49,000 pounds activity involving a combination of chemical and thermal destruction of protein d. Units include integral biosecurity materials. Advantages of alkaline include: e. Equipment available by lease or a. May be portable or fixed contract. b. Natural process Potential problems with microwave technology include: c. Destroys pathogens, including prions a. Limited number of units available d. Reduces mass by 95% b. Limited experience in non-medical environment e. Environmentally safe with proper operation c. May require moderate upfront funding f. Byproduct may be used in fertilizer or as a soil additive. d. Limited knowledge in the industry. Potential problems associated with alkaline One of the few providers of microwave hydrolysis include: sanitizers is Sanitec out of California and Indiana, at telephone 818/565-5566. a. Limited availability 8. Chemical Pretreatment b. Limited industry knowledge Chemical pretreatment is a preprocessing of contaminated waste materials to prevent c. Limited cycle capacity and the spread of pathogens and to stabilize relatively long processing times the materials until ultimate disposal d. Strong base (high pH) required decisions can be made. The process attention to potential burn hazards involves relatively low hazard materials such as mild acids, mild bases, lime or e. Effluent must be pretreated before similar materials. discharge, or shipped to a large waste disposal facility. Advantages of the chemical pretreatment are: One producer of portable alkaline hydrolysis technology is Bio-Response a. Contains pathogen spread, Solutions of Pittsboro, ID at telephone stabilizes contaminated waste, 317/892-5200. and reduces objectionable 7. Microwave Sterilization decomposition Microwave sterilization is a process b. Relatively easy to do, simple in which contaminated materials are blending process macerated, exposed to superheated steam, and then transported past 6 to 9 c. Natural process microwave heating sources at a speed d. Kills most pathogens, but not appropriate for the pathogens to be prions destroyed. The byproduct is described as a “sterile confetti” that can be e. Low environmental impact disposed in a non-hazardous material land fill or incinerator. The process was f. Low cost. originally developed for the processing of Potential problems related to chemical contaminated medical waste. pretreatment include: Some of the advantages of microwave technology include: a. Grinding or other preprocessing a. May be portable or fixed may be required before effective mixing can occur b. Existing technology in the medical industry b. Biosecurity monitoring critical during process implementation 6 DRAFT GUIDANCE Contaminated Waste Disposal

c. Limited experience in the industry. resources in safe and appropriate disposal.

Biosecurity is critical during the handling, Definitions processing, and transportation activities related to any disposal method. Special Alkaline Hydrolysis - Alkaline hydrolysis is a attention is required to keep the waste processing activity involving a combination contamination spreading during clean-up of chemical and thermal destruction of protein activities. materials Method Selection Clearance Goals - Clearance goals are the goals and predictions of what exactly is the expected The selection of the disposal method for result after the remediation process. These goals contaminated or suspected contaminated should be designed before any work begins to materials and clean-up wastes is critical to the insure that residual risks are reduced to levels effectiveness of the remediation process. The consistent with risk management rationales as determination of which method(s) of disposal are determined by state, federal, and local officials. to be used depends on the contaminant involved, the potential hazards, any specific regulations, Gasification - Gasification is enclosed the volume of contaminated material, available incineration which limits the amount of air in resources, the urgency of removal, and available the combustion chamber; thereby reducing the funds. The disposal method should be a simple emission contaminants and smoke. as possible, with the least possible exposure, Incineration - Thermal destruction of materials processing, packaging, and transporting by open or trench burn, portable burn box, possible. It must be acceptable to the agency portable incinerator, industrial furnace, or fixed having jurisdiction for the accomplishment of the commercial waste incinerator facility clean-up and any other agency that must approve the return to normal operation. Once selected, MSWLF - municipal solid waste landfill the method(s) should be explained to all response Prions - A microscopic protein particle thought to personnel involved so they can understand the be the infectious agent responsible for Mad Cow influence of their activities on the effectiveness of Disease, scrapie and certain other degenerative the method and how to minimize their unnecessary diseases of the nervous system exposure to potential hazards relate thereto. All disposal activities must be thoroughly documented and regularly evaluated. If a selected disposal method proves inadequate to address all of the contaminated materials present, additional methods should be implemented until the event is resolved. Every effort should be made to do the right thing right the first time in order to avoid having to do the activity again or differently.

Information and Assistance Information and assistance on the subject of event related waste disposal is available from the agencies responsible for regulating food and feed production (NC Department of Health and Human Services and the NC Department of Agriculture and Consumer Services, transportation of materials (NC Department of Transportation and NC Department of Public Safety), response safety (NC Department of Labor) and environmental permitting (NC Department of Environment and Natural Resources). Also, organizations involved in food processing and production, hazardous material incident response, and catastrophic event response can provide advice, referrals, and

7 DRAFT GUIDANCE Contaminated Waste Disposal

Notes

Innovative Food Defense Project

Contact Dr. Cosby at 919-733-7366 ([email protected]) for more information

8 DRAFT GUIDANCE INNOVATIVE FOOD DEFENSE PROGRAM 11

Sanitary Equipment Design

If a food processing plant and some or all of the refrigerated or frozen ready-to-eat (RTE) foods Utilities produced have been contaminated with microbial • Compressed air systems including air adulterants, careful steps must be taken to rid filters the plant of these adulterants and help prevent • Ice makers their recurrence. This document is provided in a • Refrigeration systems including freezers series to address recommendations on controls to reduce the potential of contamination of RTE Common Situations that have resulted in foods. The topics addressed include: Contamination of RTE Foods • Personnel • The design, construction and operation of There are a number of scenarios that have been your plant identified as having contributed to the microbial • The design, construction and maintenance contamination of RTE Foods. These include but of equipment, and are not limited to the following: • Sanitation Controls • Used equipment is brought from storage This specific document is provided to give and installed in the process line without recommendations regarding equipment and through cleaning specifically addresses Sanitary Design. • A new employee who is not properly trained is delegated to help clean process Potential sources of contamination in RTE foods equipment can include but are not limited to: • Raw or under-processed food is brought into the area where cooked food is held Food Contact Surfaces • Maintenance workers move from raw • Fibrous and porous-type conveyor belts areas to packaging machines without • Filling and packaging equipment changing clothes or properly washing their • Work Tables hands • Belts, peelers and collators • Heat exchangers become compromised • Containers, bins, tubs, baskets (have pinhole leaks) • Slicers, dicers, shredders and blenders • Equipment parts, food bins, tubs, etc. are • Utensils cleaned on the floor • Gloves • Improper use of footbaths Non-contact Surfaces • Employees arrive for work in dirty clothes • In-floor weighing equipment or boots and are not provided with a • Cracked hoses change • Hollow rollers for conveyances Who Should Follow The Guidance in this • Equipment framework • Open bearings Document? • Motor housings We would recommend that any processor of RTE • Maintenance tools (screwdrivers, foods would benefit by following the guidance wrenches) provided by this document and other documents • On/Off switches in this series. The guidance is especially • Cleaning tools (brushes, brooms, scrapers) formulated for those processors who have had • Condensate drip pans products recalled or their facility closed due to • Forklifts, hand trucks, trolleys and racks microbially contaminated foods either by the • Trash cans FDA or NCDA&CS. However, we believe that all • Pallets for ingredients and product DRAFT GUIDANCE Sanitary Equipment Design

RTE foods processors will benefit from following adequately cleanable and properly maintained. these recommendations to help avoid the product Also, that the design, construction and use contamination/plant closure scenario. shall preclude the adulteration of the food with lubricants, fuel, metal fragments, contaminated How Does this Document Relate to the FDA water, or any other contaminants. In addition, the GMPs and Other Regulations? equipment shall: This document is not meant to provide any • Be corrosion resistant in food contact areas Guidance which contradicts FDA’s GMPs. If • Be installed and maintained to facilitate one studies the GMPs, you find that binding cleaning of equipment and adjacent areas requirements for the processing of food are given • Be of non-toxic materials as shall while the non-binding recommendations • Resist the environment of use and action of are given as should. The guidance and food recommendations in this document are meant to • Resist cleaning compounds and sanitizing compliment those of the GMPs. Other regulations agents must be followed such as milk products producers must follow the Grade A Pasteurized Milk All seams in food contact areas shall be smoothly Ordinance and shellfish products producers must bonded and maintained to minimize accumulation follow the National Shellfish Sanitation Program of food, dirt and thus minimize the opportunity Model Ordinance. for growth of microorganisms. There are some groups such as 3-A Sanitary Standards that assure such manufacturing and assure you that Understanding Your Ingredients, Process and great thought has gone into the design. Some Finished RTE Product manufacturers offer at least two versions of the One must understand their intended RTE equipment, those with the seal and those without. food product thoroughly to determine the best Those without the seal often have some sanitary ingredients, process and packaging. For example, flaws and you should be very aware of what has products that may contain L. monocytogenes can caused the lack of seal. be formulated with listeristatic control measures The above references offer some vague words such as pH less than 4.4, water activity less than such as smoothly bonded and adequately or equal to 0.92 or containing inhibitory control cleanable that you may not fully understand. In substances. Approved processes that have been fact, we find that inadequate equipment often is proven in given foods to reduce viable cells of sold. Lack of proper maintenance is often another a given microbe such as Listeria with heat to issue. You must periodically inspect and test reduce the viable cells by six orders of magnitude your equipment such as leak testing of tanks for (6 D process) require great knowledge and pinhole leaks which will develop after years of use testing to confirm validity. Storage practices for and must be found and repaired. ingredients and finished product must be known and controlled. The design and construction Materials in product contact and adjacent areas of the plant is also important. This document generally are of stainless steel construction. While especially addresses equipment issues and most such equipment is of Type 304 stainless provides recommendations and guidance to help steel, some products that have high acid or high provide the framework for control of microbial salt require that construction be of Type 316L contamination of RTE foods. stainless steel to assure corrosion resistance. The stainless steel seams must be welded by a Design and Construction of Equipment and properly certified and trained welder. Then these Processes seams must be ground to a No. 4 finish to eliminate any divots, crevices, or other imperfections where General: We recommend that all equipment microbial contaminates could accumulate. You purchased for an RTE food plant be designed and must remember that for stainless steel to remain constructed to facilitate cleaning. The equipment non-corrosive, it must be thoroughly cleaned and should not have notches, crevices or folds where then allowed to dry such that the passive layer is food and/or water can accumulate and allow restored. microbial populations to accumulate and multiply. Care must also be taken in the non-food contact The GMPs require that (C, Sec. 110.40) all zones to assure cleanability. For example, the equipment and utensils shall be so designed structural framework located below the product and of such material and workmanship as to be contact zone may be carbon steel. However, 2 DRAFT GUIDANCE Sanitary Equipment Design

the carbon steel must be properly prepared and • That food packaging materials are safe constructed. It should be sandblasted, fabricated and suitable with smooth-ground continuous welds and then • Sanitation is under the supervision of one painted with FDA approved epoxy paint. or more competent individuals • All reasonable precautions are taken Holding, Conveying and Manufacturing Systems: The • Testing procedures shall be used to identify GMPs require that such systems be so constructed failures and contamination that they can be kept in a clean condition. The above are to ensure that the food is not Hand Wash Stations: Hand washing stations should contaminated. If contaminated, the food shall be be equipped with hands free sinks and hands free rejected or if permissible, treated or processed to soap and towel dispensers. Hot and cold water eliminate the contamination. must be provided. Hand sanitizer dispensers should also be installed. Specific Recommendations Refrigeration and Freezer Units: The GMPs require Design and Construction: We recommend that that refrigeration and freezer areas where foods all equipment you purchase and use should be are held be fitted with an indicating thermometer designed and constructed to facilitate cleaning or other device to precisely measure temperature. and minimize any areas where microbial Also, the GMPs require that such areas either harborage and multiplication can occur. Stainless have automatic temperature controls or an steel (AISI 300 series or better) and food grade alarm that will indicate failure to maintain plastic/rubber is preferred. Painted surfaces desired temperature. Shelves used in the units should be avoided due to paint flaking. to refrigerate or freeze foods should be designed so that there is adequate air flow and that foods Modification: We recommend that any equipment cannot be contaminated. Condensate drip being modified be constructed in such manner pans should be adequately designing such that as to facilitate cleaning and minimize any areas condensate is not allowed to flow into foods or where microbial harborage and multiplication on food contact surfaces. Fans on refrigeration/ can occur. Welding should be performed by freezer units should be cleaned on a regular mechanics with experience in food processing basis. equipment. Instruments and Controls: The GMPs require that Equipment Motors and Electrical Conduit: Motors instruments and controls used for measuring, should be water proof and totally enclosed to regulating or recording temperature, pH, acidity, prevent collection of organic matter and allow water activity, or other conditions that control or easy cleaning. Termed a washdown motor, a type prevent the growth of microorganisms in food of Totally Enclosed Fan Cooled (TEFC) specific shall be accurate and adequately maintained. for food processing facilities, this motor type is Further, that the proper number for designated recommended by USDA and should use USDA uses is required. approved paints when required. Electrical conduit should be spaced off walls for easy cleaning Compressed Gasses: The GMPs require that air and should enter power boxes on the side or and other gasses such as CO2 mechanically underneath the box. introduced into food or used to clean food-contact surfaces or equipment shall be maintained in such Catwalk Framework, Table Legs, Conveyor Rollers and a way that the food is not contaminated. Air filters Racks: We recommend that they be constructed have been an area where problems have been such that water cannot accumulate and harbor observed and demand special attention to prevent microorganisms (not hollow or foam filled). Also, the introduction of microbial contaminants. Air that they be positioned to avoid contamination of filters should be replaced on a regular basis as foods or food contact surfaces. Conveyors should determined by sanitary SOP. be designed for easy disassembly to facilitate cleaning and sanitizing. Cloth backed conveyor Production and Process Controls. The GMPs belts should not be used. In addition, conveyor require that all operations shall be conducted in belts should be easily dismantled without specific accordance with adequate sanitation principles. tools for easy cleaning. Further, these additional requirements are mandated: Ladders and Stairs: We recommend that all have plates or pans with upturned edges to prevent • Appropriate quality control operations debris from shoes falling onto the process line. shall be employed Extension and step ladders should be color coded 3 DRAFT GUIDANCE Sanitary Equipment Design

and dedicated to specific areas of the facility. Equipment in Dry Process Areas: Some areas of RTE facilities such as spice blend rooms and dry mix Drains: Floor drains must be installed to ensure areas have equipment that must be maintained adequate draining in the processing area. They and cleaned in a dry manner. We recommend should be easy to clean and resistant to corrosive that appropriate measures should be developed chemical used during cleaning and sanitizing. and followed for this equipment. Cleaning can Installation should also be done to prevent any be done with vacuums or CO2 pellet cleaners. back-ups during normal use. We recommend Disinfection can follow with special wipes such as that equipment not be installed over drains. alcohol impregnated ones that do not introduce Floor Clearance: We recommend that all equipment moisture into this special environment. have at least an 18 inch floor clearance for any Sections of the GMPs (21 CFR part 110) that food contact apparatus including conveyor must be considered in all decisions regarding pathways to facilitate cleaning and sanitation. the maintenance of equipment used in plants Lubricants: We recommend that all lubricants have producing RTE Foods include but may not be added and approved bactericidal agents (sodium limited to the following: benzoate) to avoid contamination. 110.35 (d) (1) 110.80 (b) (1) 110.40 (a) 110.40 (g) Evaporator Coils: We recommend that condensate 110.80 (b) (2) be directed through hose or pipe directly to the drain. Definitions Hose Nozzles: We recommend that hose nozzles Clean in place (CIP) means a system to clean piping never be allowed to remain on the floor—either or equipment without disassembly, where interior fix the length or attach spring loaded retractors. product zones are fully exposed and soil can be Hose nozzles can be a high risk surface due to washed away with a cleaning solution and then repeated hand contact. They should be cleaned sanitized with a properly diluted sanitizer. and sanitized on a regular basis and replaced when necessary. Clean out of place (COP) means a system used to clean parts and pieces after disassembly. Heat Exchangers: We recommend that product pressures in heat exchangers always be highest Critical food-contact surface means a surface that on the product side. contacts food, or a surface from which drainage onto the food or onto surfaces that contact the Equipment Maintenance: We recommend that you food in the ordinary process when the food is not have a preventive maintenance program in place being subjected to an approved control process. that includes the following: Critical non-food contact surface or area means 1. Program designed to minimize a surface (other than food contact) that could, breakdowns and prevent contamination. through action of man or equipment contaminate 2. Written program for scheduled a food that will thereafter not be subjected to the examination and attention to valves, approved control process. gaskets, o-rings, pumps, screens, filters and heat exchangers. Finished RTE Food means a refrigerated or 3. Frequency for maintaining and frozen RTE Food that has been processed by an replacement of air filters to assure proper approved process and is packaged. operation 4. Tools for use in areas where RTE foods Ready-to-Eat (RTE) Food means a food that is processed or exposed should be dedicated customarily consumed without cooking by the for use and washed and sanitized prior to consumer or that appears to be suitable for use each use. without cooking. 5. Program to clean and sanitize equipment FDA refers to the U.S. Food and Drug after renovation or maintenance. Administration. Record Keeping: We recommend that you must not NCDA&CS refers to the N.C. Department of only have the proper procedure but also a system Agriculture and Consumer Services. that reviews and documents that the SOP was followed and a record of when and who confirmed this.

4 DRAFT GUIDANCE Sanitary Equipment Design

We recommend that you also familiarize yourself with the definitions found in 21 CFR 110.3 which you can access on FDA’s internet website for Center for Food Safety and Applied Nutrition (CFSAN).

References and Acknowledgements Substantial portions of this document were suggested or directly obtained from FDA Draft Guidance Document: Control of Listeria monocytogenes in Refrigerated or Frozen Ready- to-Eat Foods. Feb. 2008. and the American Meat Institute Sanitary Design Checklist

5 DRAFT GUIDANCE Sanitary Equipment Design

Notes

6 DRAFT GUIDANCE Sanitary Equipment Design

Notes

7 DRAFT GUIDANCE Sanitary Equipment Design

Notes

Innovative Food Defense Project

Contact Dr. Cosby at 919-733-7366 ([email protected]) for more information

8 DRAFT GUIDANCE INNOVATIVE FOOD DEFENSE PROGRAM 12

Sanitary Food Plant Design and Construction

Introduction • Cleaning tools (brushes, brooms, scrapers) If a food processing plant and some or all of the • Condensate drip pans refrigerated or frozen ready-to-eat (RTE) foods • Forklifts, hand trucks, trolleys and racks produced has been contaminated with microbial • Trash cans adulterants, careful steps must be taken to rid • Pallets for ingredients and product the plant of these adulterants and help prevent their recurrence. This document is provided in a Utilities series to address recommendations on controls • Compressed air systems including air to reduce the potential of contamination of RTE filters foods. The topics addressed include: • Ice makers • Refrigeration systems including freezers • Personnel • The design, construction and operation of Common Situations that have resulted in your plant Contamination of RTE Foods • The design, construction and maintenance of equipment, and There are a number of scenarios that have been • Sanitation Controls identified as having contributed to the microbial contamination of RTE foods. These include but This specific document is provided to give are not limited to the following: recommendations regarding plant design and specifically addresses Sanitary Food Plant Design • New or used equipment is installed in the and Construction. process line without through cleaning • A new employee who is not properly trained is delegated to help clean process Potential sources of contamination in RTE equipment Foods can include but are not limited to: • Raw or under-processed food is brought Food Contact Surfaces into the area where cooked food is held • Maintenance workers move from raw • Fibrous and porous-type conveyor belts areas to packaging machines without • Filling and packaging equipment changing clothes or properly washing their • Work Tables hands • Belts, peelers and collators • Heat exchangers become compromised • Containers, bins, tubs, baskets (have pinhole leaks) • Slicers, dicers, shredders and blenders • Equipment parts, food bins, tubs, etc. are • Utensils cleaned on the floor • Gloves • Improper use of footbaths Non-contact Surfaces • Employees arrive for work in dirty clothes • In-floor weighing equipment or boots and are not provided with a • Air and water hoses change • Hollow rollers for conveyances Who Should Follow The Guidance in this • Equipment framework • Open bearings Document? • Motor housings We would recommend that any processor of RTE • Maintenance tools (screwdrivers, foods would benefit by following the guidance wrenches) provided by this document and other documents • On/Off switches in this series. We believe that all RTE foods • Equipment control panels DRAFT GUIDANCE Sanitary Food Plant Design and Construction

processors will benefit from following these processed,stored, and finished should be isolated recommendations to help avoid the product as much as possible to reduce the potential for contamination/plant closure scenario. contamination of RTE foods via air, aerosols, employee traffic, equipment and supplies. How Does this Document Relate to the FDA Equipment washing areas, testing laboratories, GMPs and Other Regulations? maintenance areas, waste storage areas, offices and toilet facilities are areas that should be This document is not meant to provide any isolated. In addition to the isolation step, plans Guidance which contradicts FDA’s GMPs. If should be developed to assure that positive air one studies the GMPs, you find that binding pressure is maintained in the RTE areas. The requirements for the processing of food are given positive pressure should be maintained with a as shall while the non-binding recommendations HEPA filtered air supply. are given as should. The guidance and recommendations in this document are meant to Sections of the GMPs (21 CFR part 110) that must compliment those of the GMPs. Other regulations be considered in all decisions regarding plants must be followed such as milk products producers producing RTE Foods include but may not be must follow the Grade A Pasteurized Milk limited to the following: Ordinance and shellfish products producers must 110.20 (b) (2) 110.20 (b) (4) follow the National Shellfish Sanitation Program 110.20 (b) (6) 110.20 (b) (7) Model Ordinance. 110.20 (d) (4) 110.35 (a) 110.35 (c) 110.37 (b) Understanding Your Ingredients, Process and 110.40 (a) 110.80 (b) (13) Finished RTE Product The following specific steps provide specific One must understand their intended RTE guidance for the areas and operations listed: food product thoroughly to determine the best ingredients, process and packaging. For example, Positive Pressure Air Supply: Areas where RTE foods products that may provide an environment for are processed or exposed should have positive L. monocytogenes growth can be formulated air pressure established by a filtered air source. with listeristatic control measures such as pH The filtration to remove bacteria and molds and less than 4.4, water activity less than or equal to yeast is best accomplished by a High Efficiency 0.92 or containing inhibitory control substances. Particle Air (HEPA) filter with an efficiency rating Keep in mind, however, inhibiting the growth of of 99.97-99.99 %. Prefilters before the HEPA filter pathogens DOES NOT guarantee the safety of the are often required to remove gross contamination product if the pathogen is present in the product first and help extend the life of the HEPA filters. in a dormant state. This was shown all too well in If HEPA filtration is not possible, then we would the Salmonella outbreak in peanut butter of 2009. recommend that filtration be done using final filters of at least 90-95 % at 1 micron. In all Approved processes that have been proven cases, a very rigorous program of maintenance in given foods to reduce viable cells of a given and replacement is necessary to protect the microbe such as Listeria with heat to reduce positive pressure air and assure that it does not the viable cells by six orders of magnitude (6 D become a contamination liability concern. The process) require great knowledge and testing to Raw and RTE areas should either be separated confirm validity. Storage practices for ingredients by air flow (Figure A) or by partitions (Figure B). and finished product must be known and We recommend that HEPA filtered air is directed controlled. The design and construction of the into the RTE Processing Area and that a positive plant is also important. This document especially pressure be maintained at all times. addresses plant design and construction issues and provides recommendations and guidance to Condensate: We recommend that you design and help provide the framework for control of microbial build your facility such that condensate cannot contamination of RTE foods. drip into or otherwise enter any RTE foods during preparation. You need to protect foods, raw Sanitary Design and Construction for RTE Food materials and packaging materials by eliminating Plants Design of RTE Food Plant— condensate or installing cleanable and self- General Considerations. draining pans where it cannot be eliminated. We would recommend that you separate RTE Elimination can be accomplished by steps such food production areas from raw food areas. In as exhausting vapors from cooking areas, using general, the areas where RTE foods are prepared, dehumidifiers and providing adequate ventilation. 2 DRAFT GUIDANCE Sanitary Food Plant Design and Construction

Standing water on floors must be avoided at all junctions should be beveled, not at 90% angle, times. and sloped toward drains. Bare concrete is porous and normal wear and tear from traffic, Containers: We recommend that a detailed plan equipment, water pressure, and temperature be established and utilized for all containers that variations will cause cracks and abrasions. The are used in the preparation and processing areas cracks and pores in concrete make it an ideal for RTE Foods. This can be accomplished by: surface to harbor bacteria. Bare concrete is suitable for warehouses but not production areas. • Distinguish between containers used for Recent advances in polymer technology have product, rework and waste widened the choices for flooring. Polyurethane, • Clearly label containers vinyl esters, acrylics, and various epoxies have • Select containers that can be easily been developed as seamless floor coatings cleaned designed for specific purposes of nonporous, slip • Dedicate containers by function and chemical resistance, hygiene, resistance to (ingredients, product, rework or waste) repeated traffic and easy cleaning. Polyurethane • Dedicate containers by area (one set concrete mixtures have been developed for food where product is processed or exposed, processing areas and anti-microbial additives one set for raw product areas, and (silver ions) can be added to flooring mixtures • Use color coding by function and area to which are reported to inhibit bacterial growth. identify the containers and their intended Some food processors still use acid brick/dairy use. tile flooring because of its durability but grout will Air and Compressed Gas: We recommend that you loosen over time and be subject to contamination. dry and filter compressed gases and air that are Design and Construction of Sanitary Equipment: used for injection into the product or for cleaning We recommend you obtain and study Sanitary product contact surfaces. The dehydration should Equipment Design which is a companion be done at the source of the compressed gas. document in this series. The filtration should take place at the point of use utilizing a filter that will retain anything larger Floor Drains: We recommend that floor drains be than 0.3 microns. These filters should be well designed and installed such that standing water maintained. around drains is eliminated. In this regard we recommend that: Construction Materials: We recommend that the materials selected and the design and • Drains are accessible for cleaning and construction in those areas where RTE foods are function well prepared processed and exposed be assessable • Trench drains are eliminated in RTE food for cleaning, resist deterioration by food, cleaners areas. If not possible, that the trench and sanitizers and prevent the harborage of drains be equipped with automatic flushing microorganisms. This should include walls, mechanisms floors, drains, doors, windows, and overhead • Drains conform to applicable plumbing fixtures in RTE foods plant areas where foods are codes being prepared or are exposed. Windows should • Drains do not flow to RTE food preparation not be allowed in such areas. Windows should areas from raw areas. not be allowed in production areas and in those • Restrooms are downstream from RTE food areas where RTE foods are exposed. We do not areas recommend the use of wood in any area of the • Slope of floors to drains equal to or plant that are wet, that are wet cleaned or that exceeds 0.25 inches per foot would allow for the contamination of the food. • Sewer lines are not located above areas Avoid painting floors, walls and equipment that where RTE foods are processed are habitually wet to avoid paint chipping and flaking. Ice: We recommend that you store ice and ice utensils in a manner that protects the ice from Floors require special attention due to their microbial contamination. Further, that ice exposure to chemical abuse, temperature transport systems and/or containers be clearly fluctuations, human and equipment traffic, and identified and protected. stress of heavy machinery. Floors in disrepair can very easily harbor pathogens leading to Equipment: We recommend you obtain and study cross contamination, an area receiving increased Sanitary Equipment Design which is a companion attention from regulatory agencies. Floor to wall document in this series. 3 DRAFT GUIDANCE Sanitary Food Plant Design and Construction

Equipment for Transport: Carts, forklifts, mobile and positive sewer flow is maintained. Also, that racks, pallet and pallet jacks are known all wastewater treatment systems be maintained sources of potential contamination. Therefore, and periodically inspected such that they do not we recommend that you designate one set of become a source of microbial contamination. The such equipment to areas where RTE foods are drains from areas where RTE foods are processed prepared and processed. We recommend that or exposed should be located upstream from raw you clean and sanitize the wheels of all transport preparation areas, trash accumulation areas, devices before they enter areas where RTE foods RTE foods equipment washing and sanitation are processed or exposed. Color coding should areas and personnel sanitation rooms. be used to identify transport items dedicated to RTE food preparation and exposure areas from Traffic Flow:To minimize the possibility of microbial those where raw materials are handled or stored. contamination, we recommend that you control the traffic flow pattern for people, food products Water Systems: Water systems should be properly and equipment. designed, installed and maintained such that backflow and cross-connections between potable Dry Storage: We recommend that dry storage and non-potable water lines and systems are not areas for materials and packaging always be allowed. Hot and cold water must be present at kept dry. Forklifts and other transports from wet all hand washing stations. Hands free sinks, and areas should not be allowed to wet these areas. hands free soap and towel dispensers should be If possible, transport necessary materials for a used at every hand wash station. Also, all water shift into wet areas before processing begins to treatment systems be maintained and periodically help alleviate these issues. Dry powder sanitizers inspected such that they do not become a source should be used for foot traffic areas. of microbial contamination. Roofs: The roofs should be well designed to avoid Brines and Reused Water: We recommend that you leakage into dry storage and process areas. discard or decontaminate continuous use brines Periodically, the roofs should be inspected and and recycled water that will be used in contact properly maintained as necessary. with RTE foods with sufficient frequency to control Receiving of Raw Materials and Supplies: The receipt any organisms of concern. Recycled rinse water of these materials should be properly controlled. used in fresh produce production can become an Truck drivers should not be wandering through important source of contamination if not properly the facility and if necessary to enter the premises decontaminated. The decontamination can be must be trained in proper sanitary practices. Dirty accomplished by means such as heat treatment, pallets should not be unloaded and restacked chlorination, UV or other effective means. on cleaned and sanitary pallets. Door openings Pallets: We recommend that wood pallets not be should be controlled by air curtains or plastic used in RTE foods preparation areas or in areas strips. where these foods may be exposed. Thus, only Dumpster and Refuse Areas: Areas where trash pallets made of materials and of construction that and refuse are collected can be the source of they can be washed and sanitized should be used. contamination. These areas should be kept clean Personnel: We recommend you obtain and study and personnel should understand that they must Personnel Sanitation which is a companion not bring dirty containers back into the facility document in this series. before they are cleaned and sanitized. Employees involved in these processes must clean their boots Sanitation: High pressure water hoses should not and should change their outer garments before be used while RTE foods are exposed or after entering the cleaner areas of the plant. Gloves equipment has been sanitized for use. This helps should be disposed of, hands washed and new or prevent aerosols from contacting RTE foods, food sanitized gloves added before entering cleaner contact surfaces, food packaging materials and areas of the plant. It is recommended that only personnel handling these foods. We recommend designated employees attend to these functions, you obtain and study Sanitation and Cleaners that the containers and employee garments and Sanitizers which are companion document in be color coded and that flow back and forth be this series. minimized if possible.

Sewer System: We recommend that the sewer Outside the Facility: Maintain the exterior of systems be properly designed, installed and the premises to discourage rodent and insect maintained such that backups are not allowed contamination and allow proper pest control to 4 DRAFT GUIDANCE Sanitary Food Plant Design and Construction

further help avoid these issues. No grass, weeds, We recommend that you also familiarize yourself water accumulation or trash should be allowed with the definitions found in 21 CFR 110.3 which adjacent to the facility. you can access on FDA’s internet website for Center for Food Safety and Applied Nutrition Wastewater Treatment/Pretreatment: If necessary, (CFSAN). such facilities should be carefully designed and located. They should never be upwind from prevailing winds or near air intakes. Storage References and Acknowledgements of sludges and residuals should be carefully Substantial portions of this document were controlled to avoid odors and not allow them suggested or directly obtained from FDA to become reservoirs of potential microbial Draft Guidance Document: Control of Listeria contamination. monocytogenes in Refrigerated or Frozen Ready- to-Eat Foods. Feb. 2008 Sanitizers should be carefully selected as to the chemicals chosen and the amounts used to avoid Frank Moerman. Hygienic Design of Food damage to the facility wastewater systems or to Processing Facilities. Food Safety Magazine. municipal systems (POTWs) if discharged to the Oct./Nov. 2010. same. Citric acid and Peracetic acid (PAA) have been demonstrated to have such impacts if not Gregory Muddell. Facility Design: Defining Floor judiciously utilized. Coating Expectations. Food Safety Magazine. 2011. Definitions Don Graham. Process Control—In-plant Air Handling and Food Safety: There is a Connection. Clean in place (CIP) means a system to clean Food Safety Magazine June/July 2011. piping or equipment without disassembly, where interior product zones are fully exposed and soil can be washed away with a cleaning solution and then sanitized with a properly diluted sanitizer. Clean out of place (COP) means a system used to clean parts and pieces after disassembly. Critical food-contact surface means a surface that contacts food, or a surface from which drainage onto the food or onto surfaces that contact the food in the ordinary process when the food is not being subjected to an approved control process. Critical non-food contact surface or area means a surface (other than food contact) that could, through action of man or equipment contaminate a food that will thereafter not be subjected to the approved control process. Finished RTE Food means a refrigerated or frozen RTE Food that has been processed by an approved process and is packaged. Ready-to-Eat (RTE) Food means a food that is customarily consumed without cooking by the consumer or that appears to be suitable for use without cooking. FDA refers to the U.S. Food and Drug Administration. NCDA&CS refers to the N.C. Department of Agriculture and Consumer Services.

5 Appendix 1 Who Should Follow The Guidance in this Document? Appendix 1 Who Should Follow The Guidance in this Document? We would recommend that any processor of RTE Foods would benefit by following the guidance pro- Appendix 1 WevidedWho would Should by this recommend Followdocument The thatand Guidance anyother processor documents in this Document? of RTE in this Food series. s would We benefit believe by that following all RTE theFoods guidance processors pro-

videdwill benefit by this from document following and these other recommendations documents in this to series. help avoid We believe the product that all contamination/plant RTE Foods processors Appendix 1 WhoWe would Should recommend Follow The that Guidance any processor in this Document? of RTE Food s would benefit by following the guidance pro- closure scenario. DRAFT GUIDANCE Sanitary Food Plant Design and Construction videdwill benefit by this from document following and these other recommendations documents in this to series. help avoid We believe the product that all contamination/plant RTE Foods processors closureWe would scenario. recommend that any processor of RTE Foods would benefit by following the guidance pro- Appendix 1 Who Should Follow will benefit The Guidance from following in this theseDocument? recommendations to help avoid the product contamination/plant vided by this document and other documents in this series. We believe that all RTE Foods processors closure scenario. Figure A. Separation of Raw and RTE Areas by Air Flow We would recommendHowwill benefit Does that this from any Document followingprocessor Relatethese of RTE recommendationsto Food the sFDA would GMPs benefit andto help byOther following avoid Regulations? the the product guidance contamination/plant provided by this documentclosure scenario. and other documents in this series. We believe that all RTE Foods processors How Does this Document Relate to the FDA GMPs and Other Regulations? will benefit fromThis following document these is not recommendations meant to provide to anyhelp Guidan avoid cethe which product contradicts contamination/plant FDA’s GMPs. If one studies the How GMPs, Does thisyou findDocument that binding Relate requirements to the FDA GMPs for the and processing Other Regulations? of food are given as shall while the closure scenario.This document is not meant to provide any Guidance which contradicts FDA’s GMPs. If one studies non-binding recommendations are given as should. The guidance and recommendations in this docu- HowThisthe GMPs, document Does thisyou findDocumentis not that meant binding Relate to provide requirements to the any FDA Guidan GMPs for thece and whichprocessing Other contradicts Regulations? of food FDA’s are given GMPs. as shallIf one while studies the

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processgenesactivity growth lessand thanpackaging. can or be equal formulated For to example, 0.92 withor containing prolisteristaticducts thatinhibitory co mayntrol provide measurescontrol ansubstances. suchenvironment as pH Keep less for than in L. mind, monocyto- 4.4, however,water Oneinhibiting must theunderstand growth of their pathogens intended DOES RTE NOTfood guaranproducttee thoroughly the safety to of determine the product the if bestthe pathogen ingredients, is Understandinggenesactivity Your Ingredients,growth less than can or be Pr equal ocessformulated to and 0.92 Finished withor containing listeristatic RTE Product inhibitory control measurescontrol substances. such as pH Keep less than in mind, 4.4, however,water processpresent andin the packaging. product in For a dormant example, state. products This thatwas mayshown provide all too an well environment in the Salmonella for L. monocyto- outbreak in activityinhibiting less the than growth or equal of pathogens to 0.92 or DOES containing NOT guaran inhibitorytee thecontro safetyl substances. of the product Keep if in the mind, pathogen however, is

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uct must be knownSanitaryand guidance and Designcontrolled. to andhelp Construction Theprovide design the and framework for co RTEnstruction Food for Plants co ofntrol the ofplant microbial is also contamimportant.ination This of RTE Foods. document especiallyDesign addresses of RTE Food plant Plant—General design and construction Considerations issues. Weand would provides recommend recommendations that you separate RTE Sanitary Design and Construction for RTE Food Plants and guidance toDesignfood help production provide of RTE Foodthe areas framework Plant—General from raw for food co Considerationsntrol areas. of microbial In general,. We contam the would areasination recommend where of RTE RTE Foods. thatfoods you are separate prepared, RTE processed,stored, and finished should be isolated as much as possible to reduce the potential for con- SanitaryDesignfood production of Design RTE Food andareas Plant—General Construction from raw food for Considerations areas.RTE Food In general, Plants. We the would areas recommend where RTE thatfoods you are separate prepared, RTE Legend processed,stored,tamination of RTE andFoods finished via air, should aerosols, be isolatedemployee as traffic, much asequipment possible toand reduce supplies. the potential Equipment for con- food production areas from raw food areas. In general, the areas where RTE foods are prepared, taminationDesignwashing of areas, RTE of RTEFood testing Foods Plant—General laboratories, via air, aerosols, maintenanceConsiderations employee ar. eas, traffic, We waste would equipment storage recommend areas,and supplies. that offices you andEquipment separate toilet facili-RTE Direction of air flow Vest. - Vestibule Sanitary Designprocessed,stored, and Construction and for finishedRTE Food should Plants be isolated as much as possible to reduce the potential for con- taminationwashingtiesfood are production areas areas, of thatRTE testing areas Foodsshould laboratories,from via be raw air,isolated. aerosols,food maintenance areas. In addition empl Inoyee general, arto eas, traffic,the thewasteisolation equipment areas storage step,where areas,andplans RTE supplies. shouldfoodsoffices are be andEquipment prepared,developed toilet facili- to Hand wash station Equip - Equipment cleaning Design of RTE Foodwashingtiesassureprocessed,stored, are Plant—General that areas areas, positive that testing andshould air Considerations finishedlaboratories,pressure be isolated. should is maintained maintenance. beWeIn additionisolated would in the recommend artoaseas, themuchRTE wasteisolation areas. as possiblethat storage The step, you positive to areas,separateplans reduce shouldpressureoffices RTEthe bepotentialand should developed toilet befor facili- con- to food productionassuremaintainedtamination areas that from ofpositivewith raw RTE a food FoodsHEPA air areas.pressure filteredvia air, In aerosols,isairgeneral, maintained supply. theempl areas inoyee the where traffic, RTE areas. RTE equipment foods The positiveare and prepared, supplies. pressure Equipment should be Footbath IPC - In-process cooler ties are areas that should be isolated. In addition to the isolation step, plans should be developed to processed,stored,maintainedwashing and finished areas, with testing shoulda HEPA laboratories, be filtered isolated air as supply.maintenance much as possible areas, to waste reduce storage the potential areas, offices for con- and toilet facili- assure that positive air pressure is maintained in the RTE areas. The positive pressure should be Equipment decontamination RR - Restroom tamination of RTEties Foodsare areas via air,that aerosols, should be empl isolated.oyee traffic, In addition equipment to the andisolation supplies. step, Equipment plans should be developed to maintained with a HEPA filtered air supply. washing areas,assure testing that laboratories, positive air maintenance pressure is maintainedareas, waste in storage the RTE areas, areas. offices The positive and toilet pressure facili- should be R.M. - Raw material Sections of the GMPs (21 CFR part 110) that must be considered in all decisions regarding plants pro- ties are areas thatSectionsducingmaintained should RTE of be Foodsthewith isolated. GMPs a include HEPA (21 In filtered CFR butaddition maypart air not110) tosupply. the be that limitedisolation must to be step, the considered followingplans should in: all be decisions developed regarding to plants pro- assure that positive air pressure is maintained in the RTE areas. The positive pressure should be Sectionsducing RTE of Foodsthe GMPs include (21 CFRbut maypart not110) be that limited must to be the considered following in: all decisions regarding plants pro- maintained with a HEPA filtered air supply. ducing RTE Foods include but may not be limited to the following: Sections of the GMPs (21 CFR part 110) that must be considered in all decisions regarding plants pro-

ducing RTE Foods include but may not be limited to the following: From FDA Draft Guidance Document: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-to-Eat Sections of the GMPs (21 CFR part 110) that must be considered in all decisions regarding plants pro- Foods. Feb. 2008 ducing RTE Foods include but may not be limited to the following: 6 Appendix 1 Who Should Follow The Guidance in this Document? Appendix 1 WeWho would Should recommend Follow The that Guidance any processor in this Document? of RTE Food s would benefit by following the guidance pro- Appendix 1 videdWho Should by this Followdocument The and Guidance other documents in this Document? in this series. We believe that all RTE Foods processors We would recommend that any processor of RTE Foods would benefit by following the guidance pro- DRAFT GUIDANCE will benefit from following these recommendations to help avoid the product contamination/plant Appendix 1 Sanitary Food Plant Design and Construction WeWhovided would Should by this recommend Followdocument The that and Guidance anyother processor documentsin this Document? of RTE in this Food series. s would We benefit believe by that following all RTE the Foods guidance processors pro- closure scenario. Hollow rollers for conveyances videdwill benefit by this from document following and these other recommendations documents in this to series. help avoid We believe the product that all contamination/plant RTE Foods processors Weclosure would scenario. recommend that any processor of RTE Foods would benefit by following the guidance pro- will benefit from following these recommendations to help avoid the product contamination/plant Equipment framework Figure B. Separation of Raw and RTE Areas by Partitions vided by this document and other documents in this series. We believe that all RTE Foods processors closure scenario. Howwill benefit Does this from Document following Relatethese recommendationsto the FDA GMPs andto help Other avoid Regulations? the product contamination/plant Open bearings closureHow Does scenario. this Document Relate to the FDA GMPs and Other Regulations? This document is not meant to provide any Guidance which contradicts FDA’s GMPs. If one studies Motor housings theHow This GMPs, document Does thisyou findDocumentis not that meant binding Relate to provide requirements to the any FDA Guidan GMPs for thece and whichprocessing Other contradicts Regulations? of food FDA’s are given GMPs. as shallIf one while studies the

Maintenance tools (screwdrivers, wrenches) non-binding recommendations are given as should. The guidance and recommendations in this docu- ThisHowthe GMPs, document Does thisyou Documentfindis not that meant binding Relate to provide requirements to the any FDA Guidan GMPs for thece and whichprocessing Other contradicts Regulations? of food FDA’s are given GMPs. as shallIf one while studies the mentnon-binding are meant recommendations to compliment arethose given of theas should GMPs.. OtherThe guidance regulations and mustrecommendations be followed such in this as docu-milk On/Off switches the GMPs, you find that binding requirements for the processing of food are given as shall while the productsThisment document are producersmeant is to not compliment must meant follow to provide thosethe Grade of any the AGuidan GMPs.Pasteuce rizedOther which Milk regulations contradicts Ordinance must FDA’s and be shellfishGMPs. followed If products one such studies as pro- milk non-binding recommendations are given as should. The guidance and recommendations in this docu- Equipment control panels ducerstheproducts GMPs, must producers you follow find the thatmust National binding follow requirementstheShellfis Gradeh Sanitation A Pasteu for the rizedProgram processing Milk Model Ordinance of food Ordinance. areand given shellfish as shall products while pro- the ment are meant to compliment those of the GMPs. Other regulations must be followed such as milk non-bindingducers must recommendationsfollow the National are Shellfis givenh asSanitation should. ProgramThe guidance Model and Ordinance. recommendations in this docu- Cleaning tools (brushes, brooms, scrapers) products producers must follow the Grade A Pasteurized Milk Ordinance and shellfish products pro- ment are meant to compliment those of the GMPs. Other regulations must be followed such as milk ducers must follow the National Shellfish Sanitation Program Model Ordinance. Condensate drip pans productsUnderstanding producers Your must Ingredients, follow the Pr ocessGrade and A Pasteu Finishedrized RTE Milk Product Ordinance and shellfish products producers must follow the National Shellfish Sanitation Program Model Ordinance. Understanding Your Ingredients, Process and Finished RTE Product Forklifts, hand trucks, trolleys and racks One must understand their intended RTE food product thoroughly to determine the best ingredients,

UnderstandingprocessOne must and understand packaging. Your Ingredients, their For intendedexample, Process RTEpro ducts foodand Finished productthat may thoroughlyRTE provide Product an to environment determine the for bestL. monocyto- ingredients, Trash cans genes growth can be formulated with listeristatic control measures such as pH less than 4.4, water UnderstandingOneprocess must and understand packaging. Your Ingredients, their For intendedexample, Process RTE pro ductsfood and Finished productthat may thoroughlyRTE provide Product an to environment determine the for best L. monocyto- ingredients, activity less than or equal to 0.92 or containing inhibitory control substances. Keep in mind, however, Pallets for ingredients and product processgenes growth and packaging. can be formulated For example, with prolisteristaticducts that co mayntrol provide measures an suchenvironment as pH less for than L. monocyto- 4.4, water Oneinhibiting must theunderstand growth of their pathogens intended DOES RTE NOTfood guaranproducttee thoroughly the safety to of determine the product the if bestthe pathogen ingredients, is genesactivity growth less than can or be equal formulated to 0.92 with or containing listeristatic inhibitory control measurescontrol substances. such as pH Keep less than in mind, 4.4, however,water Utilities processpresent andin the packaging. product in For a dormant example, state. products This thatwas mayshown provide all too an well environment in the Salmonella for L. monocyto- outbreak in activityinhibiting less the than growth or equal of pathogens to 0.92 or DOES containing NOT guaran inhibitorytee thecontro safetyl substances. of the product Keep if in the mind, pathogen however, is genespeanut growth butter canof 2009. be formulated with listeristatic control measures such as pH less than 4.4, water Compressed air systems including air filters inhibitingpresent in the the growth product of in pathogens a dormant DOES state. NOT This guaran was showntee the all safety too well of the in the product Salmonella if the pathogenoutbreak inis activity less than or equal to 0.92 or containing inhibitory control substances. Keep in mind, however, presentpeanut butterin the productof 2009. in a dormant state. This was shown all too well in the Salmonella outbreak in Ice makers inhibitingApproved theprocesses growth that of pathogens have been DOES proven NOT in guarangiven foodstee the to safetyreduce of viable the product cells of ifa giventhe pathogen microbe is suchpeanut as butterListeria of with 2009. heat to reduce the viable cells by six orders of magnitude (6 D process) require presentApproved in processesthe product that in ahave dormant been state.proven This in give wans shownfoods to all reduce too well viable in the cells Salmonella of a given outbreak microbe in Refrigeration systems including freezers great knowledge and testing to confirm validity. Storage practices for ingredients and finished prod- Approvedpeanutsuch as butterListeria processes of with 2009. heatthat haveto reduce been theproven viable in cellsgiven by foods six orders to reduce of magnit viableude cells (6 of D aprocess) given microbe require uct must be known and controlled. The design and construction of the plant is also important. This suchgreat as knowledge Listeria with and heat testing to reduce to confirm the viablevalidity. cells Storage by six orderspractices of formagnit ingredientsude (6 D and process) finished require prod- Approveddocument processesespecially thataddresses have been plant proven design inand give constructionn foods to reduce issues andviable provides cells of recommendations a given microbe greatuct must knowledge be known and and testing controlled. to confirm The validity.design and Storage construction practices of for the ingredients plant is also and important. finished prod- This Common Situations that have resulted in Contamination of RTE Foods suchand guidance as Listeria to with help heat provide to reduce the framework the viable for cells co ntrolby six of orders microbial of magnit contamudeination (6 D process) of RTE Foods. require uctdocument must be especially known and addresses controlled. plant The design design and and construction construction issues of the and plant provides is also recommendations important. This great knowledge and testing to confirm validity. Storage practices for ingredients and finished prod- documentand guidance especially to help addressesprovide the pl antframework design and for constructioncontrol of microbial issues and contam providesination recommendations of RTE Foods. There are a number of scenarios that have been identified as having contributed to the microbial con- uct must be known and controlled. The design and construction of the plant is also important. This tamination of RTE Foods. These include but are not limited to the following: and guidance to help provide the framework for control of microbial contamination of RTE Foods. documentSanitary Design especially and Constructionaddresses plant for design RTE Food and Plants construction issues and provides recommendations

New or used equipment is installed in the process line without through cleaning andSanitary guidance Design to andhelp Construction provide the framework for RTE Food for Plantscontrol of microbial contamination of RTE Foods. Design of RTE Food Plant—General Considerations. We would recommend that you separate RTE A new employee who is not properly trained is delegated to help clean process equipment foodSanitary Design production of Design RTE Food andareas Plant—General Construction from raw food for Considerations areas.RTE Food In general, Plants. We the would areas recommend where RTE thatfoods you are separate prepared, RTE processed,stored, and finished should be isolated as much as possible to reduce the potential for con- Raw or under-processed food is brought into the area where cooked food is held DesignSanitaryfood production of Design RTE Food andareas Plant—General Construction from raw food for Considerations areas.RTE Food In general, Plants. We the would areas recommend where RTE thatfoods you are separate prepared, RTE Legend tamination of RTE Foods via air, aerosols, employee traffic, equipment and supplies. Equipment foodprocessed,stored, production areas and fromfinished raw should food areas. be isolated In general, as much the as areas possible where to RTEreduce foods the are potential prepared, for con- washingDesign of areas, RTE Food testing Plant—General laboratories, maintenanceConsiderations ar.eas, We waste would storage recommend areas, that offices you and separate toilet facili-RTE Maintenance workers move from raw areas to packaging machines without changing clothes Direction of air flow Vest. - Vestibule processed,stored,tamination of RTE andFoods finished via air, should aerosols, be isolatedemployee as traffic,much asequipment possible to and reduce supplies. the potential Equipment for con- tiesfood are production areas that areas should from be raw isolated. food areas. In addition In general, to the theisolation areas step,where plans RTE shouldfoods are be prepared,developed to or properly washing their hands taminationwashing areas, of RTE testing Foods laboratories, via air, aerosols, maintenance employee ar eas,traffic, waste equipment storage andareas, supplies. offices andEquipment toilet facili- Hand wash station Equip - Equipment cleaning assureprocessed,stored, that positive and air finishedpressure should is maintained be isolated in the as muchRTE areas. as possible The positive to reduce pressure the potential should befor con- washingties are areas areas, that testing should laboratories, be isolated. maintenance In addition artoeas, the wasteisolation storage step, areas,plans shouldoffices beand developed toilet facili- to Heat exchangers become compromised (have pinhole leaks) maintainedtamination ofwith RTE a FoodsHEPA filteredvia air, aerosols,air supply. empl oyee traffic, equipment and supplies. Equipment Footbath IPC - In-process cooler tiesassure are that areas positive that should air pressure be isolated. is maintained In addition in the to theRTE isolation areas. The step, positive plans shouldpressure be should developed be to washing areas, testing laboratories, maintenance areas, waste storage areas, offices and toilet facili- Equipment parts, food bins, tubs, etc. are cleaned on the floor assuremaintained that positivewith a HEPA air pressure filtered isair maintained supply. in the RTE areas. The positive pressure should be Equipment decontamination RR - Restroom ties are areas that should be isolated. In addition to the isolation step, plans should be developed to maintained with a HEPA filtered air supply. Improper use of footbaths Sectionsassure that of thepositive GMPs air (21 pressure CFR part is maintained110) that must in the be RTEconsidered areas. Thein all positive decisions pressure regarding should plants be pro- R.M. - Raw material ducing maintained RTE Foodswith a include HEPA filtered but may air not supply. be limited to the following: Employees arrive for work in dirty clothes or boots and are not provided with a change Sections of the GMPs (21 CFR part 110) that must be considered in all decisions regarding plants pro- Sections ducing RTE of theFoods GMPs include (21 CFRbut maypart 110)not be that limited must to be the considered following in: all decisions regarding plants pro-

ducing RTE Foods include but may not be limited to the following: Sections of the GMPs (21 CFR part 110) that must be considered in all decisions regarding plants pro- From FDA Draft Guidance Document: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-to-Eat ducing RTE Foods include but may not be limited to the following: Foods. Feb. 2008 7 DRAFT GUIDANCE Sanitary Food Plant Design and Construction

Notes

Innovative Food Defense Project

Contact Dr. Cosby at 919-733-7366 ([email protected]) for more information

8 DRAFT GUIDANCE 13 INNOVATIVE FOOD DEFENSE PROGRAM

Risk Factors and Risk Communication

Major factors of any remediation strategy are the remediation process and prevent worker safety and risk communication. Normal airborne contaminants from exiting the safety precautions used during day-to-day remediation area, if required operations of the facility are not sufficient to protect employees during a contamination event • Determine the safety risks of any chemicals and remediation. Also, all employees should or equipment to be used during the be made aware of restricted areas in the facility restoration process where remediation is taking place. All safety • Establish defined area for short term procedures instituted should comply with relevant storage of supplies and waste components OSHA, EPA and other regulatory guidelines. • Establish defined offsite area for cleaning Before initiating the remediation process facility items removed from contaminated area managers must: • Designate employees as monitors at entry • Determine the affected areas of the facility and exit sites of the remediation site to and immediately restrict access to only record adherence to the required safety qualified safety personnel until the risks protocols established. These individuals can be determined can also keep track of PPE supplies and • Determine the virulence of the contaminant proper sanitizer concentrations (e.g., and risk of infection to personnel at the site footbaths) • Determine level of PPE required for Risk Communication personnel A communication team should be established to train all workers involved in the remediation • Install temporary enclosures to isolate the of new, mandatory safety procedures, extra PPE contaminated area(s) that may be required, and the specific work zones where these extra safety measures are required. • Establish standard work zone(s) for worker All employees not involved in remediation must protection and to limit accidental spread of be trained to avoid remediation work zones. the contaminant Likewise, employees involved in the remediation • Restrict access of the work zone(s) to only process must be trained to adhere to any those employees involved in remediation decontamination procedures required before exiting the remediation work zone for other areas • Institute specific decontamination of the facility. Likewise, it is important that the procedures for personnel, equipment, and communication team ensures entry/exit monitors tools leaving the contaminated area(s) as are well trained in their duties, especially record needed keeping. These records will be necessary as part • Train all remediation workers in the proper of the documentation the facility presents to local, use of PPE, decontamination procedures, state, and federal officials prior to their approval and restricted areas of the remediation process and resumption of production. • Establish specific exposure times for employees in the remediation zone if In addition, the communication team may be required required to deal with the media, law enforcement, and regulatory and public officials, depending • Install air handling systems to deal with on the seriousness of the contamination and noxious fumes and dust released during distribution of the contaminated product. This DRAFT GUIDANCE Risk Factors and Risk Communication

is especially important if the contamination is an intentional event. It is critical that only one individual be assigned the task of spokesperson to ensure complete, non-contradictory and consistent communication to the outside world. The communication team along with owners, managers, and supervisors will contribute to any reports required but the reporting should be assigned to one individual.

Innovative Food Defense Project

Contact Dr. Cosby at 919-733-7366 ([email protected]) for more information