Regulatory Support

The IEH Division of Regulatory Compliance provides confidential services to food producers. The Division informs businesses on designing and implementing system oriented approaches under all nine HACCP process categories (slaughter–all species, raw product–ground, raw product–not ground, thermally processed–commercially, sterile, not heat treated–shelf stable, heat treated–shelf stable, fully cooked–not shelf stable, heat treated but not fully cooked–not shelf stable, product with secondary inhibitors–not shelf stable).

The Division also advises clients on designing and implementing programs to meet other regulatory requirements. Food producers regardless of size understand that historical, current, and even emerging food safety and regulatory expectations must be effectively addressed in their food safety regulatory programs. When food safety and other regulatory programs fail, a response that is timely and effective is needed to answer the regulatory concerns, protect the public, and protect the customer base. When microbiological or chemical analysis is needed, the Division is backed by an internationally recognized, accredited, full service laboratory.

Background

The IEH Division of Regulatory Compliance has extensive experience in all facets of food regulation and food safety, including expertise gathered from top level management of Federal inspection and enforcement programs. The Division offers its clients in-depth insight gained from management of key food safety and regulatory change events, such as international and multi-state outbreaks, recalls and precedent setting enforcement actions, along with the reasons why those events drive specific regulatory activity, programs and enforcement. Accordingly, the Division is uniquely situated to advise clients on effectively navigating the regulatory landscape in order to develop food safety systems that consistently produce safe food. The Division adopts a preventive, all hazard, systems based approach when developing or auditing every aspect of food safety systems and regulatory programs.

Trouble strikes even well managed food producing companies. Producing adulterated product, implementing a recall, failing to account for allergens, treating livestock inhumanely, positive residue findings, and unfavorable regulatory audits happen, often unexpectedly. This is not the time to learn what a regulatory agency expects from an establishment. Whenever a negative food safety or regulatory event occurs, the Division of Regulatory Compliance assists clients in effectively and efficiently managing their path back to compliance. With the heightened regulatory scrutiny that results from problematic events, businesses need support from experienced experts to make sure they address the right problems and implement the right solutions, while responsibly addressing the concerns of regulatory officials.

Response and recovery services include:

  • Preparing responses to meat and poultry HACCP/SSOP based Notices of Intended Enforcement and Notices of Suspension in all nine HACCP processes.
  • Developing meaningful and effective corrective actions that enable a business to continue or re-start operations, followed by efficient, practical support during the subsequent 90-120 day regulatory review period.
  • Developing meaningful responses to FDA issued list of citations, observations, and letters of warning.
  • Preparing comprehensive corrective actions to humane handling suspensions, followed by hands-on implementation follow up that maintains compliance.
  • Developing noncompliance record or appeal response documents, and providing informed advise on when an is appeal likely to succeed.
  • Developing recall response, implementation, and close out activities.
  • Providing advice on media messaging, or assistance in conducting media interviews.
  • Providing epidemiological support and regulatory counsel to businesses that are the subject of preliminary outbreak or trace back investigations.
  • Responsibly addressing suspensions that result from threats, assaults, or intimidation of inspection personnel by plant personnel.
  • May 2nd, 2013
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