Salmonella Control Area ( PSCA) Guidelines December 2015 Dr. - PowerPoint PPT Presentation

Primary Salmonella Control Area ( PSCA) Guidelines December 2015 Dr. Vandana Gadre

Agenda  Historical perspective  So what does Salmonella affect ?  Why Guidelines ?  Salmonella control elements - Guidelines  Some processing examples  What is zoning  Zoning concepts  Prevention of cross contamination  Verification program  Questions??

History NUTS : 1996 (Kraft Foods – Australia)  50 illnesses from Salmonella mbandaka  Total cost to the business approximately $20 mn  Source: unclean equipment and inadequate storage of processed nuts at supplier (evidence of bird droppings) NUTS : 2007 (External Company – USA)  425 illnesses from Sal.tennessee  Total cost to the business approx. $50 - 60 Mn  Source: moisture inadvertently entering the production process allowing for growth of Salmonella organisms present at low levels in the product NUTS : 2008-9 (External Company – USA)  700 illnesses, at least 9 deaths related to S.typhimurium  Cost to the business not defined, business filed for bankruptcy liquidation  Source: not yet been identified, but gaps in CCP controls & zoning, and release of Salmonella positive material 3

History ConAgra Foods Inc. – Banquet Pot Pies 2012 cocoa powder (S. Senftenberg) • Rework stored in unprocessed / raw zone during construction 401 people in 41 states sickened in 2007 • Confusing microwave cooking instructions contributed to many of the illnesses • >75% of the people sickened in the outbreak had reported that the pies they consumed were microwaved • 2013 (2011, 2012) milk powder (S. Agona) ConAgra insisted that its pot pies were safe. Mezzanine / roof above packing zone hard to clean • Company claimed consumers who failed to cook the pies properly (harborage area) were to blame for the Salmonella outbreak • This Case prompted changes in the label instructions and warnings about the importance of thoroughly cooking frozen, not-ready-to-eat foods. 4

ConAgra Foods Inc. - Peanut Butter • Salmonella was found in a ConAgra plant in 2007 • Salmonella in jars and plant matched strains recovered from consumers. • 425 individuals became ill in 44 U.S. states and 51 hospitalized • Production stopped at the facility. • Company officials stated a roof leak and faulty sprinkler head introduced moisture into the plant which allowed Salmonella growth.

Peanut Corporation of America - Peanut Products • Over 691 people from 46 U.S. states got sick in late 2008 and early 2009 • 116 patients hospitalized and 9 deaths • 361 companies involved; > 4400 products containing peanuts, peanut butter or peanut meal were recalled • Salmonella found in product testing several times since 2007 • Plant had a history of problems: • Dirt and mold buildup throughout the plant • Gaps in doors large enough to allow rodents in • Food and non-food contact surfaces were not cleanable, properly designed, constructed, and used. • Several food contact surfaces were not properly cleaned and sanitized • Roof leaks • FDA began a criminal investigation into the actions of the Peanut Corporation of America, which they said knowingly sold contaminated peanut butter and peanut products to major food makers.

So what does Salmonella affect ? • A number of outbreaks of salmonellosis associated with the Cereal / Oats consumption of ready-to-eat low-moisture products Peanut Raw nuts / • Although Salmonella outbreaks from low-moisture products are relatively butter almonds rare, they often impact large numbers of people. • Outbreaks underscore the difficulty in eradicating Sa lmonella from the environment of dry product manufacturing facilities and illustrate the Dried Chocolates coconut wide diversity of low-moisture products that can be contaminated with Salmonella and cause illness • These outbreaks also highlight the need to reinforce industry preventive Seasoned Infant potato chips formulae control measures through guidance

Why a guideline? • For an industry-wide guidance, developed through a review of industry programs and information from the literature • The guidance is applicable to various products that include, but are not limited to Peanut butter, cereals, dry protein / dairy products, confections (such as chocolate), snacks (such as corn chips), spices, animal feeds (both ingredients and finished products), pet foods and pet treats. • Depending on the susceptibility of the product to Salmonella , all or selected practices described in this guidance may be applied.

Salmonella Control Elements Prevent ingress or spread in the processing facility. Conduct a hazard analysis for potential Segregate ingredients known to be sources – Facility/ Man/ Material Training contaminated movement / Air/ Water /Incoming RM/ Enhance stringency of hygiene practices & controls in the PSCA. Traffic control : including the Requires highest level of hygiene Barriers to separate it from the rest of movement of Man / materials. Avoid control. the facility. activities that may lead to contamination Apply hygienic design principles to building and equipment design. Sanitary design, layout and maintenance Building design Control Moisture of equipment

Salmonella Control Elements Prevent or minimize growth of Salmonella within the facility Control moisture, check equipment Remove water immediately in case of Controlled cleaning and building for harborage points ingress like leakages Establish a raw materials/ingredients control program. Evaluate supplier Food program Identify sensitive ingredients Approved suppliers including Env pathogen monitoring , Hold and release etc Validate control measures to inactivate Salmonella Challenge studies / Validate lethal step, / Operation must Determine controls, adequacy, and critical limits deliver the critical limits and monitored and met through in-plant validation,

Salmonella Control Elements Establish procedures for verification of Salmonella controls and corrective actions. If a product sample tests positive for Environmental Salmonella, the Corrective Whenever monitoring Product contact tested lot is actions must be Focus on finished product generally surface testing considered taken when implementing a COA may also testing is conducted on may be done as adulterated and Salmonella is robust dictate the need performed, the non-product part of corrective should not be detected in an environmental for finished tested lot should contact surfaces, actions for an released into environmental monitoring product testing. be isolated, samples taken environmental commerce. monitoring or program practice Hold and primarily in the positive. Retesting should finished product release PSCA not be conducted sample. for the purpose of negating the initial test results

Hygiene Zoning or PSCA

What is Zoning about ?? Zone : An area or a region distinguished from adjacent parts by a distinctive feature or characteristic.

Zoning concepts • Separation of one manufacturing area from another is generally done to minimize contaminant transfer from one area to another, e.g., wet to dry areas, “dirty” (relatively speaking) to clean areas, raw materials to finished products, or a basic hygiene area to a high hygiene • PSCA - where handling of ingredients and product requires the highest level of hygiene control • Product with pathogen inactivation treatment, the PSCA is the area subsequent to the terminal lethality step. • Where no inactivation step is employed, e.g., dry-blend mix, the entire process area may become the PSCA.

Zoning concepts • Stringent hygiene control in the PSCA depends on effective hygiene control in the rest of the processing area of the facility, which for comparison are designated the basic GMP area and, if one is established, the transitional area. • PSCA also referred to as the high hygiene zone or the high risk area (e.g., in Europe) or ready-to-eat area, the critical side, or the dry side of the operation. • The basic GMP area is also referred to as the basic hygiene area, the non- critical side or wet side of the facility • Non processing areas – Plant entrance, hallways, locker areas, cafeteria, bathrooms.

Zoning concepts • Compartmentalization or segregation of the facility - common practice • The separation of the Plant into areas of different hygiene levels with separate PSCA is key in controlling Salmonella • Number of hygiene areas may vary : depending on the product / process / intended consumer (e.g., general public, infants) • Stringency of hygiene control increases from the basic GMP area to the transitional area to the PSCA. • Emphasis on control measures for (physical) separation, passage of traffic (personnel, equipment, materials, etc.), air flow, cleaning processes (whether or not wet cleaning is permitted) and how water is used and verification

Zoning concepts • Barriers are placed between the different hygiene areas to restrict traffic and prevent vectors (potential sources of Salmonella ) from passing between the basic GMP area to the PSCA. • What are common vectors?? • Examples of physical barriers are walls, doors, split conveyors, filters, etc. • Examples of other barriers are pallet exchange, shoe-change, removal of outer bag packaging, marked limits on floors, etc.