# Presentation: 742931

## Risk Control Measure	

**Don Anderson**
**Office of Program Evaluation, Enforcement & Review**

**Notes:**
IR Matthew       		RCM  Don          

			RBI Measure and LOI  Bill

			NRs – Mr. Gioglio

## Factors in Risk Control Measure

**RTE**
** *****Lm***** Control**
** ****Alternative**
**(Status)**

**Pathogen**
**Testing **
**Results**
**(12 months)**

**Verified**
** ****Food Safety **
**Consumer**
**Complaints**
**(6 months)**

**Food**
** ****Safety **
**Recalls**
**(6 months)**

***Salmonella*****  **
**Verification**
**Category**
**(Status)**

**Public Health **
**Significant NRs**
**(6 months)**

**RCM**
**(0-100)**

**Enforcement**
** ****Status**

**Notes:**

All processing RBI establishments will have “blue bubble” data.
And nearly 3⁄4  of all plants have data from ONE OR MORE of these “Green Bubble” data sources– and in fact we have at least 6 types of data on about 1/2 of all establishments

## RCM Data Availability

**Notes:**
Only about 7% of all plants have data from ALL 7 of these “factors,” but approximately 1⁄2 of all plants have data from 6 or 7 of these factors.  

## Contribution of Risk Control Factors

**Contribution of Risk Control Factors**

**Notes:**
This slide shows the relative contribution of each of the 7 factors to the RCM in an establishment with ALL 7 factors.  About 300 actual establishments.

In establishments that– by virtue of what they produce– have fewer types of data available, the importance of each of the remaining, pertinent factors increases, but the relative  proportions remain APPROXIMATELY similar

## Public Health NRs

- First, 564 *regulatory requirements* are weighted based on how strongly they indicate a loss of food safety system process control
- Next*, NRs* are weighted based on the regulatory requirement(s) cited
- Then, a 6-month public health NR rate is computed by dividing the weighted NRs by the number of inspection procedures performed

**Notes:**
I have a back-pocket slide that shows example calcs

## Public Health NR Rates

**Notes:**
There are about 875 establishments– or about 17% of all establishments– in each of these ranges

## In-Commerce Findings

- Class I recall (3 points)
- Class II recall (2 points)
- Not-to-exceed 6 points in a 6-month window
- 1 point per verified food safety consumer complaint
- Not-to-exceed 3 points in a 6-month window

**Notes:**
Recall results are cumulative for the six-month window, with a maximum of 6 points.  For example, if an establishment experienced a Class I recall on January 1 and a Class II recall on April 1, the establishment would have 3 points from January 1 through March 31, 5 points from April 1 through June 30, 2 points from July 1 through September 30, and 0 points thereafter.

There were 14 Class I and II recalls in a recent 6 month window
+++++++++++++++++++++++++++++++++++++++++++++++++++
There were 175 establishments with verified food safety consumer complaints in a recent 6-month window, and 3⁄4 of those plants had only one complaint..  

## Enforcement Actions

- NOIE Under Deferral			2 points
- Notice of Intended Enforcement		3 points
- Suspension Held in Abeyance		3 points
- Reinstatement Held in Abeyance		3 points
- Suspension					4 points
- Inspection under Consent Order		5 points
- Reinstatement of Suspension		6 points
- Complaint to Withdraw Inspection	6 points

**Notes:**
Most establishments, of course, have had no enforcement actions in the past 6 months.

Establishments that HAVE had enforcement actions taken against them by the Agency have higher RCMs according to this formula, which will generally result in higher levels of inspection. 

## Salmonella Verification Category

- Last 2 sets prevalence </= 50% of performance std. (SVC 1) = 0 points
- Last set prevalence > performance standard (SVC 3)              = 3 points
- All others (SVC 2)             = 1 point

**Notes:**

A plant’s SVC is used as an indicator of how well they control Salmonella in their operations.  By the way, an establishment with an SVC of 3 in one product class and an SVC of 1 in another product class would be “scored” as a 3 in the RCM algorithm.

There are some “nuances” in the calculation of Salmonella Verification Categories.  For example, a fairly-new establishment that has had only one Salmonella set and passed it with flying colors– and doesn’t have other adverse indications– would likely be classified in SVC 1 and the NEXT set scheduled accordingly.

## Pathogen Control

**Pathogen Control in Ready-to-Eat and Certain Raw Beef Products**
*Lm*, *Salmonella*, and *E. coli* O157:H7      RTE testing program results
*E. coli* O157:H7 testing program results
- 3 points per positive pathogen finding not-to-exceed 9 points in a 12-month window

**Notes:**
In a recent 12-month window, we had E. coli O157:H7 samples AND/OR RTE product samples from about 62% of al establishments.

The average number of samples from those plants with samples was 13.  

About 95% of these plants had AT LEAST  3 samples

## RTE Lm Control Alternative

**Sanitation + Anti-Microbial Agent *****+***** Post-Lethality Treatment (0 points)**
**Sanitation + Post-Lethality Treatment    (1 point)**
**Sanitation + Anti-Microbial Agent           (2 points)**
**Sanitation Only (3 points)**

**Notes:**
A plant’s Lm control alternative is used– along with their RTE lab test results-- as an indicator of how well they control Lm in RTE products.  By the way, an establishment that uses, say, sanitation only as its Lm control in one product and sanitation + a post-lethality treatment in another of it’s products would be “scored” as a 3 in the RCM algorithm.  That is, we base their establishment score on the least-robust of their alternatives.

We know the Lm control alternative for approximately 2,250 establishments.

## Example RCM Calculation

**Notes:**
This is the “template” for about 1,440 establishments that have just these four types of data– PH NRs, verified food safety consumer complaints, food safety recalls, and enforcement actions.  

This illustration establishment produces, for example, raw intact beef, but also exemplifies plants that only, for example, produce raw ground pork sausage or just cut-up chicken.

Their PH NR rate is between 1.57% and 2.55% (from Slide # %) and 2 consumer complaints (which is just a count variable)

## Example RCM Calculation

**Notes:**
This is the “template” for one of the most common types of establishments-  those that produce RTE products only.
Therefore they have, like ALL plants, data on NRs, Consumer Complaints, recalls, and enforcement.    But they ALSO have an RTE Lm Control Alternative, and laboratory testing results (from the RTE testing programs).
The only type of data they DON’T have is an SVC, because they don’t produce any raw products with a Salmonella performance standard.
This plant had no public health recalls, verified food safety consumer complaints, or enforcement actions.  None of their (3+) RTE samples were pathogen positive.  
Their PH NR rate is between 0.9% and 1.6%, so they have 2 NR points.
They use Sanitation + Post Lethality Treatment for LM Control.
So this is an establishment for which the Agency has a lot of data, and the findings indicate the establishment had good, consistent risk control processes.