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Environmental Protection Agency – EPA Regulates water and waste water discharges

U.S. Regulatory Process Alling H. Yancy, DVM Regulatory Compliance Group Manager Gold Kist Inc. Atlanta, GA. Environmental Protection Agency – EPA Regulates water and waste water discharges.

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Environmental Protection Agency – EPA Regulates water and waste water discharges

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  1. U.S. Regulatory ProcessAlling H. Yancy, DVMRegulatory Compliance Group ManagerGold Kist Inc.Atlanta, GA

  2. Environmental Protection Agency – EPARegulates water and waste water discharges

  3. Food and Drug Administration – FDARegulates vaccines, antibiotics, and other medications, as well as the seafood industry

  4. United States Department of Agriculture – USDAFood Safety and Inspection Service – FSISRegulates the meat and poultry industry

  5. PPIA – Poultry Products Inspection Act – LawGives FSIS the authority to regulate the meat and poultry industry

  6. Title 9 CFR (Code of Federal Regulations) – Governs Animals and Animal Products

  7. Part 381 – Poultry Products Inspection Regulations Sets facility standards for inspection stations, time/temperature requirements, condemnation categories, etc.

  8. Part 416 – Sanitation – SSOP (Sanitation Standard Operating Procedures)Sets pre-operational and operational sanitation requirements

  9. Part 417 – Hazard Analysis and Critical Control Point (HACCP) SystemsSets food safety requirements

  10. Part 500 – Rules of PracticeSets standards for the various enforcement actions FSIS can take

  11. Regulations are official policies that must go through the process of rule-making

  12. Each proposed new regulation is posted in the Federal Register for a 90-day comment period

  13. Comments are accepted, and welcomed, from all parties • Consumer Groups • Private Citizens • Industry Representatives • Other Governing Agencies • FSIS personnel

  14. At the end of the 90-day period all comments are collated, reviewed and evaluated for meritChanges may, or may not, be made in the proposed regulation before final printing

  15. Directive – Official instructions, of an indefinite duration, detailing the manner by which FSIS personnel assure industry compliance with a given regulation, or set of regulations

  16. Example – FSIS Directive 5000.1 Revision 1, 05/21/03Verifying an Establishment’s Food Safety System

  17. This directive provides, “…comprehensive direction to FSIS field personnel on how they are to protect the public health by properly verifying an establishment’s compliance with the pathogen reduction, sanitation, and HACCP regulations.”

  18. Notice – Official, temporary, instructions (scheduled to expire no later than 1 year from date of issuance) detailing the manner by which FSIS personnel assure industry compliance with a given regulation, or set of regulations

  19. Example – FSIS Notice 25-05, 05/04/05Use of Microbial Pathogen Computer Modeling in HACCP Plans

  20. Even though Notices expire 1 year after issuance, they remain as policy unless/until they are cancelled, or superceded

  21. Unlike with Regulations, the creation of Directives and Notices is rarely a collaborative effort between FSIS and another party (industry, etc.)

  22. FSIS Hierarchy • IIC – Inspector-in-Charge – Highest ranking FSIS personnel in the plant – May be an SVMO, or a CSI – Work on the day/first shift in a two shift operation • SVMO – Supervisory Veterinary Medical Officer • CSI – Consumer Safety Inspector – Slaughter or Further Processing Floor Inspector • Line Inspector – FSIS personnel assigned to conduct carcass-by-carcass inspection on the eviscerating line

  23. FSIS Hierarchy • Plants with slaughter activities require the presence of a SVMO • Those without any slaughter activities (pure processing) do not require a SVMO

  24. FSIS Hierarchy • In-plant FSIS personnel do not establish, or interpret policy. They are charged with assuring that all applicable regulatory standards are met from day-to-day • The IIC assures continuity of inspection between all members of the inspection staff on both shifts

  25. FSIS Hierarchy • The Front Line Supervisor (FLS) – Circuit Supervisor – oversees operations in several plants in a small geographic area • The FLS does not establish, or interpret, policy. They are charged with assuring continuity of inspection by all inspection personnel in their circuit

  26. FSIS Hierarchy • The District Manager (DM), Deputy District Manager (DDM) and Assistant District Manager (ADM) of each of the 16 districts in the United States do not establish, or interpret, policy • They assure continuity of inspection between all inspection personnel in their district – each comprised of several states/territories

  27. FSIS Hierarchy • The Office of Program, Policy and Development (OPPD), in Washington, DC, establishes policy for all inspection staff in the United States • The personnel assigned to the Technical Services Center (TSC), in Omaha, NE, interpret policy for all inspection staff in the United States

  28. FSIS Hierarchy • The Center for Learning (CFL), in College Station, TX (at Texas A & M University) is a branch of OPPD, and is responsible for training of FSIS personnel • Trainers do not establish or interpret policy

  29. Poultry/Livestock Entry-Level Food Inspector Course • Initiated approximately 1 year ago • Course is 3.5 days (28 hours contact time) long • Delivered regionally, generally in a hotel setting • Delivered by a staff currently comprised of: • 6 veterinarians • 3 food technologists • 3 with experience outside FSIS

  30. Public Health Veterinarian Entry-Level Course • Initiated approximately 1.5 years ago • Course is 9 consecutive weeks, including 3 weeks of FSRE training • 104 hrs. classroom PHV contact time • 114 hrs. classroom FSRE contact time • 120 hrs. mentoring in-plant contact time • Similar delivery sites and staff as FI Course

  31. Food Safety Regulatory Essentials (FSRE) Course • Initiated in May 2003 • Course is 3 weeks long (114 hrs. contact time) • Similar delivery sites and delivery staff • Target audience: • In-plant Consumer Safety Inspectors • Entry-level Veterinarians • SVMOs and FLSs as determined by the District • Others

  32. FSRE Course - Goal • Course goals: • Correct misunderstandings about how to perform inspection duties in the HACCP environment • Job performance • Consistency and continuity of regulatory application • Understand the public health significance of the regulatory job

  33. FSRE Course - Objectives • Upon satisfactory completion of the FSRE Course, regulatory personnel are expected to be able to: • Perform appropriate inspection methodology • Use an effective thought process in decision-making • Document findings appropriately • Justify Regulatory Control Action per Regulations

  34. FSRE Course – Content • Comprehensive review of FSIS Dir. 5000.1, Rev. 1 • Rules of Practice – Statutes (PPIA, FMIA) • Sanitation Performance Standards • SSOP • HACCP (9 processing categories) • Pathogen Reduction (generic E. coli, Salmonella) • Raw/RTE Sampling • Slaughter Food Safety Standard (Zero Tolerance)

  35. EIAO Course • Purpose: Develop a cadre of people who are able to appropriately and accurately evaluate/assess a hazard analysis and a HACCP Plan • Target Audience: • All designated EIAO positions • Designated District Office Personnel • All Frontline Supervisors • All in-plant veterinarians • Delivery location: College Station, TX (contractual relationship w/ TAMU – Dr. Kerri Harris, HACCP Alliance Coordinator)

  36. Training Coinciding w/ Issuances • Issuances: FSIS Directives, FSIS Notices, Policy Statements • Example: As a directive is developed, training is developed • Ex/ BSE Directives • Training CD issued in close proximity to Directive issuance

  37. Industry Benefits • Uniform application of regulations and policies by regulatory personnel • Industry assured of receiving due process • Fairness • Consistency • Unfortunately FSIS training is not open to industry personnel

  38. Grant of Inspection • Approval from FSIS to operate as a federally inspected establishment, pursuant to the laws and regulations governing the meat and poultry industry • Attained by submitting a copy of the blueprints and a complete description of the management structure, processes to be run, and products to be produced

  39. Establishment/Plant Number • The official number, unique to each plant, that is assigned by USDA when a grant of inspection is approved (ex. P-40, P-17980, etc.) • This number must be affixed to all federally inspected product that enters commerce from a plant

  40. Establishment/Plant Number • Since each federally inspected plant has a unique plant number, product found in commerce can be traced back to the plant at which it was produced (ex. P-40 = Ellijay, GA & P-17980 = Sumter, SC)

  41. Inspection Operations • FSIS tasks are performed daily based upon computer generated assignments comprised of task codes • The computer knows which task codes to select, or not select, based on information supplied by the plant in the application for a Grant of Inspection

  42. Inspection Operations • Based upon the number sequence of a code, the inspector knows what task is being performed (ex. 01B series is Other Sanitation - Preoperational) • Tasks are generally of one of two types • Records review, designated as 01 • Hands-on, designated as 02

  43. Inspection Operations • Examples: • 01B01 = Other Sanitation – Preoperational Records Review • 01B02 = Other Sanitation – Preoperational Hands-on

  44. Recurrent Problems • Inaccurate/Incomplete Flow Diagrams • Hazard Analyses Missing Steps • Incomplete/Non-existent Decision Making Documents • Inaccurate/Incomplete or Non-existent Data to Validate Stated Critical Limits and/or Corrective/Preventive Measures

  45. Recurrent Problems • Failure to Address “Facilities, Equipment and Utensils” in the SSOP • Corrective Actions That Do Not Completely Address All Four Steps of 9 CFR 417.3 • Incomplete/Non-existent Validation of Monitoring/Verification Activities

  46. Recurrent Problems • Incomplete/Non-responsive Answers on Noncompliance Records • Repetitive Answers on Noncompliance Records • Inaccurate/Incomplete or Non-existent Records to Verify the Performance of Stated Corrective/Preventive Measures

  47. Intensified Enforcement Actions • Request Of Local FSIS Personnel (IIC/FLS) • Salmonella Performance Standard • Random • Foreign Reviews • Compliance Officer Reviews

  48. Intensified Enforcement Actions • Thirty-Day Letter • Notice Of Intended Enforcement Action (NOIE) • In-Depth Verification Review (IDV) • Product Recall

  49. Intensified Enforcement Actions9 CFR 500.1 (a) – Regulatory Control Action = the retention of product, rejection of equipment or facilities, slowing or stopping of lines, or refusal to allow the processing of specifically identified product

  50. Intensified Enforcement Actions9 CFR 500.1 (b) – Withholding Action = the refusal to allow the marks of inspection to be applied to products – may affect all product in an establishment, or that from a particular process

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