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Market 01 USDA FSIS — 9 CFR Part 417 / Part 416 Meat & Poultry Processing
01
USDA Food Safety and Inspection Service

HACCP and SSOP Enforcement

9 CFR Part 417  •  9 CFR Part 416  •  9 CFR Part 500

When FSIS issues a Notice of Intended Enforcement (NOIE) following a Food Safety Assessment conducted under FSIS Directive 5100.1, the establishment has three business days to submit a corrective action proposal to the District Office. The documentation gaps FSIS cites most frequently are not operational failures — they are record gaps. EPG was reverse engineered from FSIS Directive 5100.1 to produce the records that close every gap listed below, before any examination is scheduled.

Citation
What FSIS Found Missing
EPG Response
9 CFR 417.3(a)
Corrective Action — Four ElementsFour-element corrective action record missing root cause identification, CCP control restoration documentation, specific recurrence prevention measures, or product disposition. The most common basis for NOIE escalation.
9 CFR 417.5(b)
Contemporaneous RecordsCCP monitoring records not made at the time of the monitoring event — timestamps missing, entries appear to have been made in bulk at end of shift, or values implausibly uniform.
9 CFR 417.5(c)
Pre-Shipment ReviewNo documented review of all HACCP monitoring records confirming all critical limits were met before product was released for shipment.
9 CFR 417.4(a)(3)
Annual ReassessmentHACCP plan not reassessed at least once in the preceding 12 months, or process change triggered a required reassessment that was not documented.
9 CFR 416.15
SSOP Corrective ActionSanitation SOP deviation with no separate documented corrective action record — or SSOP corrective actions combined with HACCP corrective actions in a single log.
9 CFR Part 500
Organizational Failure / NOIE StandardNo management accountability documentation demonstrating that leadership was aware of and engaged with the NR pattern before FSIS determined enforcement action was warranted.

Key FSIS Directives: 5100.1 Rev.6 (Food Safety Assessment Methodology)  •  5100.3 (Administrative Enforcement)  •  5100.4 (Public Health Risk Evaluation)  •  5000.1 (Verifying Food Safety System)  •  6900.2 (Noncompliance Records)

Market 02 OSHA PSM — 29 CFR 1910.119 Cold Storage & Ammonia Refrigeration
02
Occupational Safety and Health Administration

Process Safety Management Enforcement

29 CFR 1910.119  •  40 CFR Part 68  •  OSHA CPL 02-01-065 (2024)

OSHA's 2024 Process Safety Management enforcement directive (CPL 02-01-065) is the most significant change to PSM inspection methodology since 1994 — replacing the prior Appendix A checklist with 80 pages of structured questions across 15 PSM subsections. Cold storage and ammonia refrigeration facilities face citation exposure in every subsection, almost always rooted in documentation gaps. EPG produces the governance documentation that closes those gaps before the OSHA inspector arrives.

Citation
What OSHA Found Missing
EPG Response
29 CFR 1910.119(d)
Process Safety InformationPSI documentation incomplete, not current, or not accessible to affected employees. Equipment data, material safety data, and process chemistry documentation gaps.
29 CFR 1910.119(e)
Process Hazard AnalysisPHA findings not fully documented, action items not tracked to closure, or revalidation not completed within required five-year cycle.
29 CFR 1910.119(f)
Operating ProceduresWritten operating procedures not current, not accessible, or not reflecting actual operating conditions and safe operating limits.
29 CFR 1910.119(j)
Mechanical IntegrityInspection and testing records incomplete, deficiencies not documented, corrective action on deficiencies not tracked to closure with authenticated records.
29 CFR 1910.119(l)
Compliance AuditCompliance audit findings not fully documented, corrective actions not assigned to named responsible persons, or action items not tracked to verified closure.
29 USC 654 5(a)(1)
OSHA General Duty ClauseRecognized hazard identified but no documented corrective action demonstrating the hazard was addressed and recurrence prevention measures implemented.

Key References: OSHA CPL 02-01-065 (2024 PSM Enforcement Directive)  •  IIAR 2 (Ammonia Refrigeration Standard)  •  RAGAGEP  •  40 CFR Part 68 (EPA Risk Management Program)  •  OSHA General Industry Standard 1910

Market 03 EPA NPDES — 40 CFR Part 122 Wastewater Treatment
03
Environmental Protection Agency

National Pollutant Discharge Elimination System

40 CFR Part 122  •  Clean Water Act 33 USC 1342  •  40 CFR Part 136

Wastewater treatment facilities regulated under NPDES permits face EPA enforcement actions — Notice of Violation, Compliance Schedule, Consent Order — when Discharge Monitoring Reports contain gaps, corrective action documentation does not close the loop, or permit conditions cannot be demonstrated through authenticated records. The EPA enforcement sequence mirrors every other federal enforcement framework: documentation gaps determine outcomes. EPG produces the governance documentation that closes those gaps before the next inspection.

Citation
What EPA Found Missing
EPG Response
40 CFR 122.41(a)
Duty to Comply — Permit NoncompliancePermit limit exceeded without documented corrective action identifying cause, steps taken to return to compliance, and specific measures to prevent recurrence.
40 CFR 122.41(l)(6)
Noncompliance ReportingNoncompliance not reported to the permitting authority within required timeframe, or report does not include all required information in authenticated, dated format.
40 CFR Part 136
Monitoring RecordsDischarge monitoring records incomplete, not signed by authorized representative, not retained for required period, or analytical methods not documented.
40 CFR 122.41(n)
Bypass — Unauthorized DischargeBypass event not anticipated, or documentation of bypass notification, cause, and corrective action not produced contemporaneously.
40 CFR Part 403
Industrial Pretreatment ProgramIndustrial user pretreatment compliance inspection records not current, monitoring records incomplete, or significant noncompliance documentation gaps.

Key References: Clean Water Act 33 USC 1342  •  NPDES Standard Permit Conditions  •  DMR Reporting Requirements  •  Stormwater Pollution Prevention Plan (SWPPP)  •  EPA Consent Order Requirements

Market 04 USCG MTSA / EPA SPCC — 33 CFR Part 105 / 40 CFR Part 112 Ports & Marine Terminals
04
US Coast Guard  •  Environmental Protection Agency

Maritime Security & Spill Prevention Enforcement

33 CFR Part 105  •  40 CFR Part 112  •  33 CFR Part 154

Port and marine terminal facilities regulated under MTSA and SPCC face USCG Captain of the Port enforcement and EPA civil penalty actions when facility security plans are not current, drill records are incomplete, spill prevention documentation does not reflect actual procedures, or corrective action records do not demonstrate closure of identified deficiencies. EPG produces the governance documentation that satisfies the federal evidentiary standard for both frameworks.

Citation
What USCG / EPA Found Missing
EPG Response
33 CFR 105.305
Facility Security AssessmentFSA not current, assessment findings not fully documented, or corrective actions from FSA deficiencies not tracked to authenticated closure.
33 CFR 105.405
Facility Security PlanFSP not current, not reflecting actual security measures implemented, or amendments not documented with effective dates and approvals.
33 CFR 105.535
Drills and ExercisesDrill records incomplete, drill deficiencies not documented, corrective actions from drill findings not tracked to closure with authenticated records.
40 CFR 112.7
SPCC Plan — Spill PreventionSpill prevention plan not current, secondary containment inspection records incomplete, or corrective actions from equipment deficiencies not documented to closure.
33 CFR Part 154
Bulk Transfer OperationsTransfer operations not documented per required procedures, communication records incomplete, or pre-transfer inspection documentation gaps.

Key References: Maritime Transportation Security Act (MTSA)  •  USCG Captain of the Port Orders  •  Clean Water Act Section 311  •  SPCC Rule Requirements  •  MARPOL / 33 CFR Part 151

Market 05 FDA FSMA — 21 CFR Part 117 Refrigerated Distribution & Food Processing
05
Food and Drug Administration

Preventive Controls & FSMA Enforcement

21 CFR Part 117  •  FDA Form 483  •  FDA Warning Letter

Refrigerated distribution facilities and food processors regulated under FSMA face FDA Form 483 observations and Warning Letters when corrective action records do not document all required elements, food safety plans are not current, supply chain program documentation is incomplete, or environmental monitoring corrective actions do not close the loop. The FDA evidentiary standard is identical to every other federal framework: documented, contemporaneous, signed. EPG produces governance documentation that satisfies that standard across all five regulated industry editions.

Citation
What FDA Found Missing
EPG Response
21 CFR 117.150
Corrective Actions and CorrectionsCorrective action record does not document all required elements — identification of the food affected, cause of the problem, steps taken to prevent recurrence, and evaluation of affected food for safety.
21 CFR 117.190
Records — General RequirementsRecords not created contemporaneously with the activity being documented, not signed and dated by the person performing the activity, or not retained for required period.
21 CFR 117.126
Food Safety PlanFood safety plan not current, not reflecting actual process, not reanalyzed following a trigger event, or not signed by the Preventive Controls Qualified Individual (PCQI).
21 CFR 117.135
Preventive ControlsMonitoring records for preventive controls incomplete, not contemporaneous, or corrective actions for monitoring deviations not documented with all required elements.
21 CFR 117.165
Verification ActivitiesVerification activities not documented, calibration records incomplete, or corrective actions identified during verification not tracked to authenticated closure.

Key References: Food Safety Modernization Act (FSMA)  •  FDA Form 483 Inspectional Observations  •  FDA Warning Letter Process  •  PCQI Qualification Requirements  •  Environmental Monitoring Program Requirements

Your citation is not listed here?

Every federally regulated facility faces the same enforcement reality: documentation gaps determine outcomes. The regulation number changes. The evidentiary standard does not. Contact EPG to discuss your specific citation and what governance documentation closes it.

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