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1998 FSIS NATIONAL RESIDUE PROGRAM

SECTION 4:  MONITORING PLAN COMPOUND SELECTION CRITERIA AND TABLE KEYS

Criterion 1.  Contribution to the meat and poultry supply - The slaughter classes have been divided into four different groups, based on their relative production level in pounds. Each group has been assigned a point value, as follows:

Descriptor Contribution Point Value
very low <0.1% 1 points
low 0.1- 0.9% 3 points
medium 1.0 - 9.9% 5 points
high 10.0 - 20.0% 15 points
very high >20.0% 20 points

Criterion 2.  Non-uniform consumption patterns - This category refers to either of two situations: (1) Where consumption of a small slaughter class (labeled as "very low" or "low" slaughter volume in Criterion 1) is concentrated within a specific segment of the population (in this case, high residue levels in this slaughter class could lead to disproportionate exposure of this subpopulation); or: (2) Where consumption of any slaughter class is particularly high among infants and children, since these subpopulations may be more sensitive to chemical residues.

  1. Disproportionate consumption by subpopulations = 5 points

  2. High consumption by infants and children = 5 points

Criterion 3.  International considerations - This category reflects any unusual concern of the international community for this compound/slaughter class pair.

  1. No special international concern = 0 points,

  2. Moderate level of special international concern = 2 points, and

  3. Exceptional international concern = 5 points

Criterion 4.  Residue violations from the monitoring program - This column represents the overall percent of samples found violative over the five year period 1991 - 1995. The levels of violations have been divided into four groups and assigned the following point values:

Descriptor % Violations Point Value
none 0.0 0 points
low 0.01 - 0.39% 5 points
medium 0.4 - 1.0% 10 points
high >1.0 % 15 points

Criterion 5.  Non-violative residue findings from the monitoring program - This column represents the overall percent of samples found to have positive, but non-violative, residue levels over the five year period 1991 -1995. The levels of non-violative positives have been divided into four groups and assigned the following point values:

Descriptor % Non-Viol. Positives Point Value
none 0.0 0 points
low 0.01% - 0.39 1 points
medium 0.4%- 1.0% 3 points
high >1.0 5 points

Criterion 6.  Violative findings from the Residue Violation Information System (RVIS) - This column represents the total number of violative samples listed in RVIS over the three year period 1993 - 1995. Point values were assigned by analyzing the distribution of RVIS violations within each compound class, and dividing these numbers of violation into four groups based on breakpoints within the distribution. Point values were assigned as follows:

Descriptor (number of violations) Point Value
none 0 points
lowest third 2 points
middle third 6 points
highest third 10 points

Criterion 7.  Regulatory intelligence information - This category reflects professional judgement by FSIS and FDA-CVM staff regarding the degree of misuse of the compound or compound class, based on regulatory intelligence information available from FSIS, FDA, and other Federal and State sources. This is considered as a supplement to information on violations provided by the monitoring program and RVIS and, in these cases, is scored as follows:

Descriptor Point Value
No/limited misuse 0 points
Moderate misuse 5 points
Substantial misuse 10 points

However, there are also cases where no historical information is available for residue violations in a particular compound/slaughter class pair. In these cases, values of "0" were, by default, assigned to columns 4, 5 (monitoring), and 6 (RVIS). However, "0" means that we sampled and did not find anything. It should not be used for cases where sampling was not done. To avoid a bias against compound/slaughter class pairs that had never been sampled, points were assigned to the regulatory intelligence category as follows:

  1. No sampling information, but knowledge of possible misuse = 10

  2. No sampling information, and no other knowledge of misuse or lack thereof = 5

  3. No sampling information, but knowledge that this compound is very unlikely to be used in his slaughter class = 0

Thus, if no regulatory intelligence information were available on a compound/slaughter class pair that has been subjected to sampling, a value of 0 is assigned to this category. But if no regulatory information is available on a compound/slaughter class pair, and it has never been sampled, a value of 5 is assigned to indicate the potential for a problem to exist.

Criterion 8.  Industry HACCP or QA/QC plans directed toward controlling the level of the compound or compound class - This category reflects the degree of analytical testing, and other practices, used by growers and slaughter establishments to ensure that residues are kept below violative levels.

  1. Extensive analytical testing and thorough HACCP or QA/QC program = 0 points

  2. Moderate analytical testing and adequate HACCP or QA/QC program = 5 points

  3. Limited analytical testing and limited HACCP or QA/QC program = 10 points

  4. Little or no analytical testing and/or little or no HACCP or QA/QC program = 15 points 

Criterion 9.  Toxicological evaluation - In this category, each compound or compound class is assigned a score for toxicity, based on current EPA and FDA tolerances. The score assigned to a compound class is based on the compound(s) in that class having the lowest tolerances. For example, antibiotics were assigned a high toxicity, based on the low (<50 ppb) tolerances of penicillin and neomycin. Scoring was assigned as follows:

Descriptor Tolerance Point Value
low toxicity >1 ppm 5 points
medium toxicity 500 ppb - 1 ppm 10 points
high toxicity 50 ppb - 499 ppb 20 points
very high toxicity <50 ppb 30 points

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URL: http://www.usda.gov/fsis/ophs/bluebook/sect4.htm
Last Updated On 03/09/1998.