Category Archives: RIS

FSIS Regulatory Compliance

USDA, Food Safety and Inspection Service (FSIS) Regulatory Services

HCG Professionals have a long (20 year) distinguished history of providing sound regulatory assistance to FSIS inspected food establishments across a wide variety of products. Whether it is food safety training, preparing for a Food Safety Assessment (FSA), addressing deficiencies noted as a result of an FSA or Noncompliance Reports (NRs) or validating your process, HCG can help plants navigate through the complex regulatory requirements and maintain, or regain compliance with applicable FSIS regulations.

HACCP Training

Utilizing International HACCP Alliance Accredited training materials, HCG has offered in-house and public HACCP training (i.e., basic and advanced) for over 20 years for the meat and poultry industry, both domestically and internationally.  The training not only teaches the scientific principles of HACCP but also its practical applications in meat and poultry establishments based on regulatory requirements.

Food Safety Assessments (FSA) Preparedness Services

FSIS has made a commitment to conduct FSAs in each establishment that processes meat or poultry products. These assessments are designed to evaluate the adequacy of the firm’s entire food safety system. These assessments are considered routine, based on the fact that a plant operates under a Grant of Inspection.

In addition to the normal FSA’s, FSIS also conducts FSA’s “for cause”. These “for cause” FSAs may be conducted due to a positive laboratory result for Listeria monocytogenes or E. coli O157:H7, STEC or a company’s product being implicated in a food illness outbreak, either as a product processor or as a supplier to another company. Other factors that may result in a FSA are multiple Non-compliance Records (NRs), especially if they are linked to a common root cause, or if a processor is involved in a product recall.

If FSIS determines that a plant’s operation is not under control, the District Manager may issue a Notice of Intended Enforcement (NOIE), or if the findings are considered severe, a Notice of Suspension (NOS). Regardless, plant management will be required to present a detailed corrective action proposal to the District Office within a limited period of time. The corrective action proposal must address the concerns that are described in the Notice. If plant management does not respond adequately, FSIS may move to withdraw inspection from the plant or the plant’s Grant of Inspection.

HCG professionals can assist plant management prepare for an FSIS, FSA by reviewing plant process control programs including HACCP, SSOP and GMP/Prerequisite programs, supporting documentation, process validation documentation, assessing plant pathogen control programs, reviewing plant sanitation procedures and reviewing plant records.

Regulatory Non-Compliance Responses (NRs, NOIEs, NOS)

From time to time, many food manufacturing facilities experience situations of noncompliance. How they respond to those noncompliance situations can mean the difference between an issue being resolved in a timely manner or an escalation of enforcement activities that, in the worst cases, lead to an interruption of plant operations.

HCG routinely assists plants minimize the impact of a noncompliance event by helping management adequately respond to government notices of noncompliance including Noncompliance Records NRs, Notices of Intended Enforcement NOIEs or Notices of Suspension (NOS).

Process Validation

The FSIS, HACCP regulations require establishments to validate the adequacy of its food safety system to control hazards reasonably likely to occur.  To expand on these requirements FSIS published Compliance Guideline – HACCP Systems Validation.

HCG Professionals can assist establishments to develop the necessary validation supporting documentation and/or assess plants’ validation data for compliance with the FSIS requirements and guidelines.

HCG Recall and Crisis Management Assistance

There can come a time when even the best run plant can find itself in a recall or crisis situation.  An ingredient supplier might change formulations or an employee may mistakenly release product under testing.   If not handled correctly, these situations can bring all plant operations under a regulatory microscope and cause uncontrollable operational or in the worst cases, legal costs.

Having a HCG professional at your side can help contain a crisis and put a plant back in operation.  HCG can help investigate the cause of the crisis, suggest actions to prevent the risk of further occurrences, act as a liaison between plant management and regulatory personnel, and assist with responding to government enforcement actions in order to return plant operations to a state of compliance.