Steve StichDirector

Safety and Inspection

Standard 6 Breakout SessionCompliance and Enforcement Program

March 12, 20148:00am – 12:00 pm

Julie LoeraFood Safety Officer

Texas Department of State Health Services

AgendaStrengthening Compliance and

Enforcement • Welcome and Introductions• Current Status of Standard 6 Implementation• Developing an Enforcement Program• Q & A• Brainstorming• Summary and Challenge• Reporting out

Housekeeping• Honor time schedule• Stay on topic • Get input from everyone• Be willing to share• Respect different program cultures• Do not reference specific audits• Be creative, ask questions – parking lot• Facilitators – responsible for process• Participants – responsible for content

Focus for Change• 31% - State programs have a compliance and enforcement

program that has written procedures to ensure that compliance actions are supported. (Ref. MFRPS 6.4)

• 15% - State programs conduct a performance review every 12 months (Ref. MFRPS 6.3)

• 13% - State programs calculate an overall rating of compliance and enforcement (Ref. MFRPS 6.3)

• 11% - State programs calculate and determine performance ratings (Ref. MFRPS 6.3)

• 30% - State programs use a risk based program (Ref MFRPS 6.3)

Breakout Sessions Objectives

• Identify resources that currently exist• Identify best practices in SOP development

and implementation that has been used by state programs

• Identify what internal verification procedures are being utilized by state programs

Standard Six

Full Conformance

(100%)80-99% 60-79% 40-59% <39%

PE Conformance Rating

3 2 8 7 198 5 21 18 49

Total StatesPercentage (%)

Standard Six

1.a 1.a.1 1.a.2 1.a.3 1.a.4 1.a.5 2.a 2.a.1 2.a.2 2.a.3

Compliance and Enforcement Program Performance Review and Enforcement Action

No. of YES 31 23 14 23 18 20 5 8 6 6No. of NO 8 16 25 16 21 19 34 31 33 33No. of NA 0 0 0 0 0 0 0 0 0 0

Standard 6 - Compliance and Enforcement Program

Julie LoeraFood Safety Officer

Texas Department of State Health Services

March 12, 20148:00 am

Standard 6 Requirement

The State program conducts a performance review of enforcement actions.

• Enforcement actions are recorded on appendix 6.2 and an overall rating is calculated to determine if internal procedures for enforcement and compliance action are followed.

• Performance ratings that fall below 80% indicate a need for improvement and require corrective action

Development Process

• Flow diagram compliance and enforcement process

• Identify steps in the process that would affect enforcement if not handled correctly

Development Process

• Flow diagram compliance and enforcement process

• Identify steps in the process that would affect enforcement if not handled correctly

• Develop procedures for selection and conducting audits

Compliance and Enforcement SOP

• Definitions– Compliance– Enforcement

• Audit Selection Procedures– Frequency– File Selection

• Audit Completion– Roles

• Audit Results

Development Process• Flow diagram compliance and enforcement

process• Identify steps in the process that would affect

enforcement if not handled correctly• Develop procedures for selection and conducting

audits• Develop auditing questions

– Set of 17 questions for compliance– Set of 7 questions for enforcement

Development Process• Flow diagram process compliance and enforcement

process• Identify steps in the process that would affect

enforcement if not handled correctly• Develop procedures for selection and conducting audits• Develop auditing questions

– Set of 17 questions for compliance– Set of 7 questions for enforcement

• Utilize Excel to determine element scoring

Schedule for Implementation

• Finalize procedures and forms April 2014• Pilot the audit in May 2014• Revisions based on Pilot in August 2014• Finalize and perform first official audit in

Oct-Nov 2014

Contact Information

Julie Loera

Food Safety Officer

Texas Department of State Health Services

Email: Julie.Loera@dshs.state.tx.us

Standard 6 – Compliance Decisions

Steve StichDirector

NYS Dept of Agriculture and MarketsDivision of Food Safety and Inspection

DateTime

STANDARD 6 COMPLIANCE PROGRAM

• Written enforcement strategies• Tracking critical and chronic violators• Risk based system• Timeline for progressive actions• Communication system

STATUTORY AUTHORITY Article 2 §20 provides statutory authority for access to premises for

inspection (refusal of access may result in request from the New York State Supreme Court for an inspection warrant).

Article 3 §39 and 40 provide authority for civil penalties for statutory and regulatory violations respectively.

Article 17 §199a provides statutory authority regarding adulterated foods Article 17 §199b provides statutory authority regarding colors Article 17 §199b provides statutory authority regarding tainted foods

(additives) Article 17 §202b provides statutory authority regarding violation of food

seizure

COMPLIANCE DECISIONS

• All decisions made by Central Office• Reports submitted electronically• Reviewed by Compliance Unit• Supported by Counsel’s Office

COMPLIANCE TOOLS• Warning letters• Civil penalties• Industry compliance sessions• Administrative hearings• Court injunctions• Warrants

LEGAL ACTION POLICY• Insanitary conditions

– Critical– General

• Food Seizure• Violation of Food

Seizure

• Operating without a License

• Adulterated Food (other)

• Misbranding

FSI-890 Back (REV. 7/04)

SANITARY INSPECTION GUIDELINES

Critical Deficiencies General Deficiencies

1. Food Received From Unapproved Sources A. *Unpasteurized milk/milk products used B. *Water or ice is not potable C. Foods or ingredients from unapproved source D. Meat, poultry, or game products are not from officially inspected plants E. *Shellfish from unapproved source F. Liquid eggs, frozen eggs, or dried milk products are not from U.S.D.A.

inspected plants 2. Food Products or Ingredients Adulterated or Unfit

A. Rodent defiled foods or ingredients B. Insect infested foods or ingredients C. Food products contain unidentified sulfiting agents or other unapproved

additives D. *Other adulterated/unfit foods or ingredients

3. Food Not Protected From Contamination By Workers A. *Food handlers handle foods when ill with a disease transmissible by foods B. *Food handlers have infected cuts or burns on their hands C. *Food handlers do not wash hands thoroughly after contaminating them D. Employee handwashing facilities inadequate for establishments handling

exposed foods E. *Employees handling exposed, ready-to-eat foods without an acceptable

protective barrier 4. Food Not Protected From Contamination By Other Sources

A. *Food contact equipment, utensils or conveyances for potentially hazardous foods: contact surfaces unclean or not properly sanitized and likely to contribute to contamination

B. *Food contact equipment, utensils, or conveyances are not cleaned or sanitized between use on different species or between raw and ready-to-eat foods

C. *Ready-to-eat foods are subjected to cross contamination from raw foods, or cross contamination between species is likely to occur

D. *Toxic chemicals are improperly labeled, stored, or used so that contamination of food is likely to occur

E. Food contact equipment condition, design or location is likely to contribute to contamination

F. Insect, rodent, bird or vermin activity likely to result in product contamination G. Evidence of leakage or backup in sewage lines H. Equipment cleaning or sanitizing facilities inadequate for establishments

handling potentially hazardous foods 5. Critical Processing Or Salvaging Parameters Are Not Met

A. *Pork products, which may be eaten without further cooking, are not treated to kill trichina

B. *(Refer to Specialized Inspection Guidelines) 6. Potentially Hazardous Foods Improperly Cooled or Refrigerated

A. *Potentially hazardous foods are not cooled by an approved method where the product temperature can be reduced to 70°F or less within two hours and 41°F (45ºF) or less within an additional 4 hours

B. *Potentially hazardous foods are not stored at safe temperatures 7. Potentially Hazardous Foods Not Adequately Cooked or Reheated

A. *Poultry, poultry stuffings, stuffed meats, or stuffings containing meat are not heated to 165°F or above

B. *All pork or any food containing pork is not heated to 150°F or above C. *Other potentially hazardous foods requiring cooking are not heated to

and/or held at required temperatures D. *Potentially hazardous foods that have been cooked and then refrigerated

are not rapidly reheated to 165°F or above (whole roast beef may be reheated to adequate time/temperature requirements)

E. *Equipment used for heating or reheating potentially hazardous foods is inadequate

8. Improper Hot-holding Procedures for Potentially Hazardous Foods A. *Potentially hazardous foods are being kept below 135°F during hot-holding

(rare roast beef may be served at 130°F or above) B. *Hot-holding equipment improperly designed, maintained, or operated to

keep hot foods at 135°F or above. CRITICAL DEFICIENCIES PRECEDED BY AN ASTERISK (*) ARE LEADING CONTRIBUTING FACTORS WHICH CAUSE FOODBORNE DISEASE.

9. Improper or Inadequate Sanitary Facilities and Controls A. Handwashing facilities improperly installed or maintained B. Suitable water temperature or adequate pressure for food processing;

equipment, utensil or container cleaning; or handwashing in establishments that do not handle exposed foods, not available

C. Toilet facilities improperly installed, equipped or maintained D. Plumbing or sinks not properly sized, installed or maintained: equipment or

floors not properly drained E. Lighting or ventilation is inadequate F. Cleaning or sanitizing equipment, materials or agents are not available,

suitable or properly stored G. Sanitizing test devices not in use where required H. Lack of certification of water potability or record for disinfection

10. Inadequate Sanitary Design, Construction and Maintenance A. Exterior of unsuitable construction or not in good physical repair B. Establishment has insufficient space to accommodate operations C. Interior floors, walls, ceilings or fixtures are not of suitable construction,

clean or well maintained D. Refuse containers not clean, covered, in good repair or removed at

sufficient intervals 11. Poor Hygiene and Activities of Food Handlers

A. Not maintaining a high degree of cleanliness or taking precautions to prevent contamination of foods from perspiration, cosmetics, chemicals or medicants, etc.

B. Not wearing clean outer garments, effective hair restraints or secure jewelry C. Eating, drinking or use of tobacco in exposed food areas D. Locker or dressing rooms are not segregated from food areas, clean or

orderly 12. Inadequate Food Storage and Protection

A. Food not stored, conveyed or displayed in a manner that prevents contamination including marginal temperature deficiencies

B. Food or ingredient storage containers are not clean, covered or properly identified

C. Bulk food displays are improperly constructed, displayed or handled D. Street clothing or soiled linen stored unsegregated from exposed food or

food-contact surfaces E. Food displays are improperly constructed, maintained or supervised F. Improper thawing procedures are utilized

13. Processing Procedures/Educational Requirements Are Not Met A. (See Specialized Inspection Guidelines) B. Other required records/certifications are not maintained C. Other coding requirements are lacking or inadequate D. Article 28 posting requirements are not met E. Consumer advisory requirements are not met

14. Insect, Rodent or Vermin Activity A. Evidence of rodents observed (not likely to result in product contamination) B. Insect, birds or other vermin observed within the establishment (not likely to

result in product contamination) C. Evidence of pets or other domestic animals in establishment

15. Equipment Utensils and Materials Adequately Utilized and Maintained A. Food contact equipment, utensils or conveyances: contact surfaces

unclean or not properly sanitized B. Non-contact food equipment, utensils or conveyances are not clean or in

good repair C. Food equipment improperly designed, constructed or maintained D. Thermometers not provided where required E. Unused equipment or materials improperly stored or in an unclean condition F. Storage cabinets or shelves are not clean or in good repair G. Packaging materials unclean, improperly stored or handled in an insanitary

manner H. Air system or transfer lines are not clean, properly constructed or in good

repair 16. Other Sanitation

A. Chemicals or pesticides improperly labeled, stored or handled B. Outside premises or loading zones improperly maintained C. Vehicles are not clean or in good repair D. Morgue area or bottle return area improperly maintained E. Shellfish tags or records improperly maintained

FSI-898 (Rev. 6/07) Back

SPECIALIZED INSPECTION GUIDELINES

17. Manufacturers of Thermally Processed, Low-Acid Foods, Packaged in Hermetically Sealed Containers A. *Processing and production records not maintained or do not indicate

product code, processing system number, container size, number of containers per coding interval, minimum initial temperature, actual processing time and temperature, mercury-in-glass and recording thermometer readings and other critical factors specified in the scheduled process

B. *Records not maintained for retort, aseptic processing or flame sterilization

C. *Recording thermometer charts do not identify lots processed. Entries during processing not signed by designated person. Record not signed by reviewer prior to release of product for distribution or within 24 hours of process, whichever is sooner.

D. *Container closure examination records not maintained or do not indicate product code, date and time of inspection, measurements, corrective actions, signed or conducted at sufficient intervals

E. *Processing systems, container closure, etc., not under supervision of certified individual

F. Blanching operation: product not handled properly or unclean G. Fillers not providing sufficient equal fills without overflows. Vacuum is

not achieved in filled containers H. *Scheduled food processes: not established by qualified individuals; not

posted or available to retort or processing system operator and inspector I. *Processing time and temperature do not meet scheduled processes J. *All baskets and other containers of unretorted food products not marked

with a heat sensitive indicator K. *Retorts, aseptic processing and flame sterilization equipment does not

meet requirements contained in Section 277.6 of 1NYCRR L. Container cooling water is not adequately chlorinated or equivalently

treated M. Each container of product not coded with establishment where packed,

product name, year packed, day packed, packing period N. *Deviations from scheduled process not identified and evaluated with

corrective action recorded

18. Acidified Foods (and Tomato Products and other Potentially Low-Acid Products) A. *Product does not achieve and maintain a finished equilibrium pH of 4.6

or lower B. *Thermal processing or permitted preservatives not used in accordance

with the scheduled process C. *Production not done under operating supervision of qualified individual D. *Sufficient control, including frequent testing and recording not exercised E. *Acidification procedures not adequate F. Containers not tested or examined at sufficient intervals and/or marked

with coding G. *Scheduled process not established by qualified individual H. *Deviations from scheduled process not identified or evaluated with

corrective action recorded I. *Adequate pH testing methods not performed to insure proper

acidification J. *Processing and production records not properly maintained

19. Water Activity Reduced Foods

A. *Water activity level of .85 or les not achieved B. *Water activity testing procedures not performed to insure proper water

activity level

20. Salvage Dealers A. Records not kept or available for damaged merchandise, merchandise

found to be unfit and salvaged merchandise. Receipt of damaged foods not properly reported to Commissioner's representative.

B. Storage of products and removal of unfit foods: All unfit foods not frequently removed; products not stored off floor, 12" from wall and/or with 18" aisles between double rows of merchandise

C. 1. Receiving room, 2. Sorting and cutting room, 3. Storage area for reconditioned merchandise, 4. Waste room, 5. Separate cleaning room (if cleaning of merchandise performed), 6. Separate retail sales area (if retail sales provided), 7. Refrigerator and/or freezer (if refrigerated and/or frozen foods are handled) not provided where required

D. *Reconditioning and Labeling: unfit merchandise is offered for sale including but not limited to: metal cans; rust pitted or with rim, seam or sharp body dents, springers, flippers and swells; food containers with press caps or screw caps having been immersed in water; unlabeled merchandise; single-service items

21. Licensable Food Operations A. *Processing of potentially hazardous foods not authorized B. Operation not licensed

22. Vacuum or Modified Atmosphere Packaging at Retail

A. *Foods packaged not restricted to those which will not support the growth of Clostridium botulinum

B. *Vacuum packaged foods not maintained at proper temperatures or not conspicuously labeled with the temperature requirements

C. *Refrigerated vacuum packaged products not given a maximum 14-day use by date and not so labeled. This expiration date exceeds the manufacturer's expiration date as indicated on the original container

D. *Conspicuous signs listing products which may be vacuum packaged and warning against packaging any other products not posted in vacuum packaging area

E. *Compliance with Clostridium botulinum control parameters not verified via written certification from the manufacturer or independent laboratory analysis on products purchased for vacuum packing

F. *Access to the vacuum packaging equipment not restricted to qualified persons

G. *Written product purchase specifications not utilized when procuring products to be vacuum packaged

H. *Detailed written in-store HACCP Plan which includes steps to minimize opportunities for product adulteration and cross-contamination not developed, not adhered to or not monitored

I. Other vacuum packing requirements not met

23. Cured, Frozen and/or Smoked Fish Processors A. *Unwholesome, unsound, adulterated or organoleptically detectably

spoiled fish are processed B. *Fish processed not free of viscera C. *Evisceration of fish not conducted in a safe, sanitary manner or

segregated from other processing operations D. *Brining procedures not properly conducted E. *Curing, freezing or smoking of fish not conducted by a controlled process

whereby the safety and wholesomeness of the fish is not adversely affected

F. *Processed fish not held or distributed at safe temperatures G. *Labeling for processed fish does not indicate the perishable nature of the

product 24. Specialized Food Processing Requiring a HACCP Plan

A. *Specialized food processing is being conducted without the required HACCP Plan

B. *Critical requirements of the HACCP Plan not met C. Other HACCP requirements not met

25. Slaughterhouse

A. Firm has made alterations to its facility prior to submitting drawings and specifications for Department review

B. Firm is slaughtering species permissible under Article 5A but not listed on their license application

C. Firm lacks a knife sterilization or disinfection system in eviscerating room D. *Firm is not returning transportation cages immediately after delivery and

lacks a separate room for cleaning or sanitizing transportation cages E. *Firm is washing/storing transportation cages outside F. *Firm is housing live birds in transportation cages G. *Product not given immediately to customer is not achieving an internal

temperature of 41°F within 5 hours of slaughter H. *Live birds/other animals were not obtained from an approved source

and/or slaughtered according to applicable animal health regulations I. *Veterinarian ante-mortem report is not present for exotic animals that

were not transported on the same day of slaughter J. *Firm accepted for processing field slaughtered, exotic animals that were

not transported on the same day of slaughter K. Firm is not maintaining ante-mortem reports for field slaughtered animals

for one full year

LEGAL ACTION POLICY (insanitary conditions)

• First Inspection– Warning Letter– $600 Penalty for * Critical

Def., and Appeal Instruction Letter

• Second Inspection– $600 For Critical, and Appeal

Instruction Letter– $1,200 For * Critical– Legal Letter (in both cases)

• Third Inspection– $1,200 for Critical, and

Industry Compliance Session– $1,200, or $400 per * Critical,

and industry Compliance Session

LEGAL ACTION POLICYFourth Inspection

• $1200 or $800 per * Critical• $1200 or $400 per Critical

$100 per General $600 Adulterated Food

• Hearing/Injunction Referral (both)

LEGAL ACTION POLICYFifth Inspection

– $1200 or $800 per * Critical

– $1,200, or $800 per Critical, and $200 per General $1,200 Adulterated food

– Service of Commissioner’s final determination of hearing, or Order of injunction

Sixth Inspection– $1,200, or $800 per

Critical, and $200 per General $1,200 Adulterated food

– Injunction referral– $1200 per * Critical– Contempt referral

LEGAL ACTION POLICY

• Interference/Harassment• Summary Suspension• Temporary Restraining Order• Inspection Warrant• Arrest Warrant

APPEALS AND COLLECTION• Counsel’s office• Appeals

• Penalty Reduction Program• Monthly Payment plan

• Collection• 2nd Reminder Letter Initiating Pleadings Served• Default Judgment Within a Year• Present Case in Court• Can Settle at any Time During Process

Contact Information

Steve Stich

Steve StichDirector

NYS Dept of Agriculture and MarketsDivision of Food Safety and Inspection

Email: stephen.stich@agriculture.ny.gov

Questions