By Jonathan Huang PhD, CFS, Staff f Office icer, r, USDA Food d - PowerPoint PPT Presentation

By Jonathan Huang PhD, CFS, Staff f Office icer, r, USDA Food d Safety y and Inspecti ection on Service ce

• FSIS Mission and Authority • FSIS Directive 6120.2 • askFSIS

We are the public health agency in the USDA that is responsible for ensuring that meat, poultry, and processed egg products are safe, wholesome, and accurately labeled. Our Authority • Federal Meat Inspection Act (FMIA), 1906 • Agricultural Marketing Act (AMA), 1946 Through a series of Acts, Congress • Poultry Products Inspection Act (PPIA), 1957 empowers FSIS to inspect all meat, • Humane Methods of Slaughter Act (HMSA), 1958 poultry, and processed egg products • Egg Products Inspection Act (EPIA), 1970 in interstate commerce. 3

• USDA – United States Department of Agriculture • FSIS – Food Safety and Inspection Service • OPPD – Office of Policy and Program Development • PDS - Policy Development Staff

• Provides leadership in the identification of policy needs, and the subsequent development of policy solutions, to address the intent and application of verification and enforcement policy in in-plant activities.

• FSIS • Food Industry • Other Federal Agencies • Congress • Consumers • Academia • Other

• Regulations: • General and permanent rules published in the Federal Register to clarify the statutes (FMIA, PPIA, EPIA) • Title 9 Code of Federal Regulations (CFR) • Parts 300-592 for FSIS. • Part 416 Sanitation • Part 417 HACCP • FSIS directives • Instructions to inspection personnel about inspection methods, regulatory decision making, documentation of noncompliance, and appropriate enforcement actions. • No expiration date until they are rescinded or replaced. • Notices • Time-sensitive instructions on workplace policies, procedures and food safety regulations. Often in response to questions from the field. • Expire one year from date of publication.

Purpose: This directive provides inspection program personnel (IPP) with instructions for verifying an establishment’s intended use of the treatment. In addition, this directive instructs IPP to perform HACCP Verification tasks in official establishments that apply the HPP antimicrobial treatment as a process step. Note: Comprehensive instructions in FSIS Directive 5000.1 for HACCP verification task and Directive 5000.6 for HAV task.

• FSIS issued a No Objection Letter to Notification Log number 03-NT004, the High Pressure Processing (HPP) as a post-lethality, post-packaging intervention method for Listeria monocytogenes contamination in ready-to-eat foods such as deli sliced meats. • When HPP is used by the establishment as antimicrobial treatment, IPP are to verify the application of HPP in the HACCP system.

• Reducing Lm in post-lethality exposed RTE meat and poultry products to qualify for Alternative 1 or Alternative 2, Choice 1 status in accordance with 9 CFR 430.4(b) • Addressing the control of pathogens in the meat and poultry products, such as STEC , Salmonella and Lm , etc.

• When an official establishment uses HPP as an antimicrobial treatment • 9 CFR 417.2(a)(1) and 417.2(a)(2)) • IPP are to verify whether the establishment: • include HPP as a process step in their flow chart and address biological food safety hazards at the HPP process step in their hazard analysis. Note : This applies to both the official establishment performing the HPP treatment and the manufacturing establishment contracting with it to perform the process.

• Example 1: An HPP establishment only performs HPP treatment for its customers. Some customers use HPP to reduce Salmonella in raw poultry products, is HPP required to be considered in its hazard analysis? • A: Yes, 9 CFR 417.2(a)(1) and 417.2(a)(2)) would apply. IPP are to verify whether the establishments include HPP as a process step in their flow chart and address Salmonella as a food safety hazard at the HPP process step in their hazard analysis.

• When an official establishment uses HPP as support for decisions in the hazard analysis • 9 CFR 417.5(a)(1) and 417.4(a)(1). • IPP are to verify whether the establishment: • Maintain supporting documentation (e.g., published journal articles, challenge studies, in-plant data, etc.) to demonstrate that the HPP process can adequately address the identified hazards. • Provide scientific supporting documentation to show the log reduction of the target pathogen and critical operation parameters (e.g., pressure, time, temperature.) • Define a process for every type of product considering factors such as pH, water activity, composition, and preservatives. Note : This applies to both the official establishment performing the HPP treatment and the manufacturing establishment contracting with it to perform the process.

Example 2: In an HPP establishment, some customers want to use HPP to reduce Salmonella in raw poultry products, what should the HPP establishment do in its HACCP system? A: The HPP establishment should work closely with its customer because both establishment should have HPP in their hazard analysis. Based on their hazard analysis, the establishments may determine food safety hazards RLTO or NRLTO during the production process (9 CFR 417.2(a)(1)). • RLTO --- CCP --- 417.5(a)(1) and 417.4(a)(1). • NRLTO --- Prerequisite program --- 417.5(a)(1) Note : Prerequisite programs also require validation, according to the FSIS HACCP Systems Validation Compliance Guideline.

Example 3: A establishment want to use HPP as a PLT to reducing Lm in post-lethality exposed RTE meat and poultry products, what should the establishment do in its HACCP system? A: Per 9 CFR 430.4, establishments that use PLTs must include the treatment as a CCP in their HACCP plan and validate the effectiveness of the PLT. As a PLT, the HPP must be validated according to 9 CFR 430.4 and 417.4 and as being effective in eliminating or reducing Lm . The establishment need to list HPP in their HACCP plan. • RLTO --- CCP --- 417.5(a)(1) and 417.4(a)(1).

• Example 4: An establishment wants to use HPP to reduce Lm in post-lethality exposed RTE meat and poultry products and has supporting document that HPP achieves full lethality, what should the establishment do in its HACCP system? • A: FSIS considers the product to be non-post-lethality exposed because a full lethality is achieved by HPP. The establishment would be exempt from requirements in 9 CFR 430. The establishment should have a decision making documentation explaining why they are exempt from 9 CFR 430 by referring to their validation.

• When an official establishment uses HPP to achieve food quality characteristics and does not include HPP in its food safety system • 9 CFR 417.5(a)(1) and 417.4(a)(1). • IPP are to verify whether the establishment: • Maintains decision-making documents to support the exclusion of the antimicrobial treatment from its hazard analysis and food safety system • Sample task will be conducted after all interventions, but prior to HPP. Example: Lm sample task will be conducted at the producing establishment before products sent for HPP.

• Example 5: An HPP establishment only performs HPP treatment for its customers. All of its customers use HPP for shelf-life extension, is HPP required to be a CCP for pathogen control at this establishment? • A: No, it is not required. If there is no CCP or prerequisite program at that step of the process, there is no requirement for validation. Shelf life extension drives the decision by IPP to sample product at the producing establishment for FSIS verification sampling because HPP is not considered an antimicrobial intervention.

• When an producing establishment sends product to an HPP establishment that performs the HPP treatment and ships the product into commerce • IPP are to verify whether the originating establishment • Includes HPP process step in its flow chart, hazard analysis, and HACCP plan, which contains all supporting documentation. • The originating establishment • Cannot complete pre-shipment review until it receives documentation back from the establishment that performs the HPP treatment. • Maintains control of the product and verifies the critical limits and critical operational parameters are met as specified in their food safety system at the completion of the process.

• A Controlled Statement of Limited Use will need to be on the shipping containers leaving producing establishment for HPP. • A "special claim" and require a sketch approval from FSIS Labelling team. • Identifies the unique identifying number of the federally inspected establishment that receives the product for treatment • AND provide sufficient detail to describe the process or treatment to which the product is subjected at the receiving HPP establishment. Example: “For Further Processing - labeled (or unlabeled) consumer packages for HPP (or for post-lethality treatment) at establishment #####.”