# Presentation: 782334

## AFSS Component 4Regulatory OversightAFSS Public MeetingOmaha, NebraskaApril 5-6, 2005Steve Traylor, Ph.D.University of Kentucky Division of Regulatory Servicesstraylor@uky.eduPhone: 859-257-6528

**Notes:**
Thank you ______.  As a state representative on this committee it is indeed my pleasure to present the next component of the draft framework for the FDA Animal Feed Safety System entitled regulatory oversight.  

## Objective

- Develop a framework for use in prioritizing and allocating inspection and enforcement resources to minimize risks to animal and human health.

**Notes:**
Current regulatory oversight is present at levels commensurate with risk to human and animal health through inspection and enforcement activities. 

Thus the objective of component 4 is to develop a framework for use in prioritizing and allocating inspection and enforcement resources to minimize risks to animal and human health.

Most of us are aware of the tightening of budgets at both the state and federal level, it was viewed by this committee that we evaluate the affect of this tightening on inspection and enforcement activities.  

## Scope

- The process should apply to FDA’s feed regulatory program activities (e.g., label review, education, inspections, enforcement and information sharing) and to similar state actions conducted using FDA authority.

**Notes:**
Although the AFSS is an umbrella program being developed by FDA, it is essential for us to consider the impact the proposed program will have on other regulatory agencies.  This is especially true when a person views the impact of such a program on the relationship between FDA and other agencies including the states.  

With this in mind the scope of this component was designed such  that 
the process should apply to FDA’s feed regulatory program activities (e.g., label review, education, inspections, enforcement and information sharing) and to similar state actions conducted using FDA authority. 

## Inspection Program

- The primary purpose of an inspection is to determine a firm’s or product’s degree of compliance with applicable regulations.
- •  Surveillance
- •  Compliance

**Notes:**
The next series of slides will cover the inspection portion of regulatory oversight component.  

The inspection programs utilized by many regulatory agencies will generally fall within two broad categories.  With the first being surveillance based inspections and lastly compliance driven inspections.  

## Surveillance Inspections

- Surveillance inspections are conducted to determine whether a firm is substantially in compliance with the regulations and operating “under control.”

**Notes:**
Surveillance inspections are conducted to determine whether a firm is substantially in compliance with the regulations and operating “under control.”  

Examples of such inspections would be GMP and BSE inspections.  

## Compliance Inspections

- Compliance inspections are conducted to evaluate a firm’s compliance with the provisions of the regulations and to document inspectional observations supporting possible enforcement action.

**Notes:**
In contract, compliance inspections are conducted to evaluate a firm’s compliance with the provisions of the regulations and to document inspectional observations supporting possible enforcement action. 

An example of this type of inspection would be a for cause inspection where the inspecting body has reasonable cause to suspect that the firm is operating out of control.

## Federal/State Interaction

- Because the majority of inspections of feed manufacturing and distribution establishments that fall under the jurisdiction of FDA are done by state agencies using federal or state authority, a strong working relationship with state counterparts should be a significant component of the FDA’s Animal Feed Safety System.

**Notes:**
When we discuss inspections it is essential to note the integral interaction between FDA and their state counterparts.  

Because a large majority of the inspections are conducted by FDA’s state counterparts, a strong working relationship should be a significant component of the AFSS.  

Of particular interest to state regulatory agencies is that under the proposed AFSS program their role in inspection and enforcement under their laws and regulations should not change.

Operating principles ___________________

## Risk-Based

- A scientific- and risk-based approach should be utilized to improve the agency’s ability to prioritize and allocate inspection resources by targeting firms, facilities, products and processes that have been identified as posing the greatest risks to animal or human health.

**Notes:**
As an extension of what was discussed in Component 2 the regulatory oversight component will utilize as risk-based approach to improve the agency’s ability to prioritize and allocate inspection resources by targeting firms, facilities, products and processes that have been identified as posing the greatest risks to animal or human health. 

## Enforcement

- FDA has a variety of enforcement options available.  Regulatory enforcement often focuses on voluntary compliance with the law and regulations.  When voluntary compliance and education are unsuccessful, the agency has other enforcement options that are available.

**Notes:**
Enforcement is the second area of regulatory oversight.  
Regulatory agencies have wide variety of enforcement options are a available.  With the enforcement focus on voluntary compliance and education.  However, when voluntary compliance and education are unsuccessful, the agency can use any one of the additional tools in their tool box including warning and untitled letters and criminal penalties.  

This concludes the background information portion of the presentation.  

## Identified Gaps

**Establishing Priorities**
**On-Farm Manufacturing**
**Transportation**
**Inspector Training**

## Identified Gap 1Establishing Priorities

- The agency has established priorities for inspections under the BSE inspection program based on a combination of risk factors.
- CVM is currently developing a risk-based inspectional approach for other feed-related inspections, which is not expected to be completed until FY 2006.

**Notes:**
The AFSS team has identified three gaps in the regulatory oversight section with Gap 1 focusing on establishment of priorities.  

In the current regulatory oversight program, the agency has established priorities for inspections under the BSE inspection program based on a combination of risk factors.  CVM is currently developing a risk-based inspectional approach for other feed-related inspections, which is not expected to be completed until FY 2006.

## CVM’s Risk-Based Inspection System

- In 2004, CVM was charged with developing a risk-based method for determining the feed products, processes and/or facilities that presented the greatest risks to animal and human health.
- CDER had just developed their risk-based model for prioritizing GMP drug inspections (September 2004).
- CVM’s Risk Based Inspection System Team is headed by Ibrahim Kamara.

**Notes:**
CVM’s risk-based inspection program is not a charge of AFSS.  To provide a brief overview and background information this topic we felt it would provide this group with information of the Risk based inspection system being considered by CVM. 

In 2004 CVM was charged with developing a risk-based method for determining the feed products, processes and/or facilities that presented the greatest risks to animal and human health.  

As many of you are aware CDER, the Center for Drug Evaluation and Research, just developed a risk-based model for GMP drug inspections.  

Ibrahim is also a member of the AFSS Team, and works to ensure that CVM’s risk-based approach for inspections will be the same, or similar to, the AFSS risk-based approach.

## CVM’s Major Compliance Programs

- The Risk-Based Inspection System will include:
- Drug pre-approval inspections
- Drug GMP inspections
- Drug post-approval inspections
- Medicated feed cGMP inspections
- BIMO inspections
- BSE inspections
- Feed contaminants inspections (pesticides, dioxin, mycotoxins, microbes, heavy metals, etc.)
- Inspections for drug, pesticides and dioxin residues in tissues

**Notes:**
Probably won’t include this in the presentation.

## Identified Gap 2Part A On-Farm

- Regulatory oversight has focused principally on the commercial medicated feed industry even though there has been a major shift to more on-farm production of all types of feed.
- Some on-farm operations are making more feed than most commercial feed companies.

**Notes:**
Identified Gap 2 Part A relates to on-farm oversight.  
As of today, regulatory oversight has focused principally on the commercial medicated feed industry even though there has been a major shift to more on-farm production of all types of feed.  Some on-farm operations are making more feed than most commercial feed companies.

The AFSS Team is developing a more comprehensive regulatory approach that will cover all segments of the animal feeding industry including transporters, mixer-feeders, and livestock producers. 

## Identified Gap 2Part B -Transportation

- Vehicles that are used to transport feed are also not receiving much inspectional scrutiny.  This can be a significant cross-contamination issue.
- Dept Transportation Act 1990  - Safeguarding Food From Contamination During Transportation

**Notes:**
Subpart B of Gap 2 relates to the transportation sector.  Part of the recent GAO report on BSE identified the transportation sector as an area of concern.  The AFSS team would like your thoughts on how to deal with this potential cross-contamination issue.  

## Identified Gap 3Inspector Training

- Ensuring the competency and proficiency of FDA field and state inspectors, compliance officers and program personnel regarding animal feed regulations, policies and program directives is essential.

**Notes:**
The AFSS Team is seeking input from all stakeholders on means for having the most knowledgeable feed inspection force possible.  
The AFSS should provide a program to ensure the competency and proficiency of the regulatory inspection staff is essential.  This would include both FDA and state inspectors.  

## Questions 

**Notes:**
This concludes my presentation.  At this time I would entertain any questions.