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

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• 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.

• Federal Meat Inspection Act (FMIA), 1906
• Agricultural Marketing Act (AMA), 1946
• Poultry Products Inspection Act (PPIA), 1957
• Humane Methods of Slaughter Act (HMSA), 1958
• Egg Products Inspection Act (EPIA), 1970

Our Authority

Through a series of Acts, Congress empowers FSIS to inspect all meat, poultry, and processed egg products 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• No expiration date until they are rescinded or replaced.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 #####.”

• Example 1. The HPP facility receives unlabeled product in a

master case/shipping container for treatment of the packages within the shipper. After HPP, the HPP facility intends to apply labels to the treated packaged product and master case.

• Response: The establishment number of either plant

(manufacturer or HPP facility) would be acceptable on the immediate container labeling, provided, the establishment number on the immediate container labeling is addressed in each plant’s HACCP plan (for tracking product). It is recommended that the master cases (shipping containers)

• f the finished product bear the establishment number of

the HPP treatment facility because they are responsible for handling the product safely in applying the HPP treatment.

• Example 2. The HPP facility receives fully labeled

prepackaged product in a shipper. After HPP treatment, the HPP facility intends to apply labels to the master case

• nly.
• Response: The master cases (shipping containers) may

bear the establishment number of the HPP facility, which is what we recommend, or, provided both establishments have control measures in place for tracking the product, it would be acceptable for the shipping containers leaving the HPP facility to bear the establishment number of the producing establishment. The preprinted labeled packages bear the number of the originating manufacturer.

• Example 3. The HPP facility receives unlabeled product that is

intended to be treated with HPP and sent back to the producing establishment for labeling and shipment into commerce. The shipping container bears the establishment number of the

• riginating processor.
• Response: When HPP treated unlabeled product is shipped back

to the producing establishment from the HPP facility, it must be shipped under company control (company seal) with appropriate documentation/records maintained. The shipping containers would bear a statement of controlled limited use. The establishment number of either the HPP facility or the manufacturer would be acceptable on the shipper going back to the originating processor, provided both establishments have control measures in place for tracking the product.

• Use HPP to reprocess adulterated product
• IPP are to verify the establishment has supporting

documentation to achieve the specified log reductions

• Establishments should use Good manufacturing practices

(GMPs) to minimize further cross-contamination and additional growth of pathogens (e.g., temperature abuse)

• Minimum expected lethalities for reprocessing
• Lm-adulterated RTE product: 5-log Lm reduction
• Salmonella-adulterated RTE product: 5-log for meat

products and 7-log for poultry products

• E. coli O157:H7-adulterated raw or RTE product: 5-log E.

coli O157:H7

• When establishment use HPP as a antimicrobial

treatment, IPP are to verify whether the establishment:

• include HPP as a process step in their flow chart (417.2(a)(2))

and address biological food safety hazards at the HPP process step in their hazard analysis (417.2(a)(1)). Note: This applies to both the official establishment performing the HPP treatment and the manufacturing establishment contracting with it to perform the process.

• When establishment use HPP as a antimicrobial

treatment in their HACCP system, IPP are to verify whether the establishment:

• Provide documentation to support decisions made in its

hazard analysis (417.5(a)(1)).

• Provide initial validation records (417.4(a)(1))

Note: This applies to both the official establishment performing the HPP treatment and the manufacturing establishment contracting with it to perform the process.

• Preferred Method:
• askFSIS
• Interactive web-based information system
• Access link on FSIS home page
• http://askFSIS.custhelp.com
• 24-hour knowledge-base search option
• Submit written questions if answer not found
• Alternate Method:
• Phone: 800-233-3935 / 402-344-5000

• Launched in August, 2007 to help answer technical and

policy-related questions from multiple stakeholders

• Searchable knowledge base covers diverse topics

(HACCP; processing; slaughter; export/import; labeling/ product amenability; sampling programs, etc. )

• http://askfsis.custhelp.com