Inspections, Compliance, Enforcement, and Criminal Investigations
Sample Schedule 1: SALMONELLA SAMPLING PLAN
To determine the presence of Salmonella in processed foods intended for human consumption.
This sampling plan is applicable to the inspection of either a continuing series of production lots or to isolated lots consisting of an identifiable collection of process units (cans, bags, packages, or similar units). This plan is for use by FDA for regulatory purposes.
Foods are listed in three categories based on the number of Salmonella hazards and whether a food is to be consumed by infants, the aged, or infirm.
The three defined Salmonella Hazards of foods are:
- The food or an ingredient of the food is a significant potential source of Salmonella;
- The manufacturing process does not include a controlled step that destroys Salmonella; and
- The food has significant potential for microbiological growth if "abused" in distribution or by consumers.
Classification of Foods:
Foods have been classified into three food Categories for regulatory sampling purposes. The foods are listed in the Categories by Product Code sequence.
NOTE: For products not listed, check with your supervisor. The District will request categorization from the Office of Field Programs/Center for Food Safety and Applied Nutrition (HFS-600), or, when time is of essence, the District will make the categorization and obtain later concurrence from CFSAN.
This includes all foods that would normally be in Category II except that they are intended for consumption by the aged, the infirm, and infants.
This includes the foods that would not normally be subjected to a process lethal to Salmonella between the time of sampling and consumption. Examples are as follows:
|PRODUCT CODE||FOOD ITEM|
|03||Bread, rolls, buns, sugared breads, crackers, custard and cream filled sweet goods|
|05||Breakfast cereals, ready to eat|
|07||Pretzels, chips and specialty items|
|09||Butter and butter products; pasteurized milk and raw fluid milk and fluid milk products for consumption; pasteurized and unpasteurized concentrated liquid milk products for consumption; dried milk and dried milk products for consumption|
|12||Cheese and Cheese products|
|13||Ice cream from pasteurized milk and related products that have been pasteurized; raw ice cream mix and related unpasteurized products for consumption.|
|14||Pasteurized and unpasteurized imitation dairy products for consumption|
|15||Pasteurized eggs, egg products from pasteurized eggs; unpasteurized eggs and egg products from unpasteurized eggs for consumption without further cooking|
|16||Canned and cured fish, vertebrates; other fish products; fresh and frozen raw oysters and raw clams, shellfish and crustacean products; smoked fish, shellfish and crustaceans for consumption|
|20-22||Fresh, frozen and canned fruits and juices, concentrates and nectars; dried fruit for consumption; jams, jellies, preserves and butters|
|23||Nuts and nut products for consumption|
|26||Oils consumed directly without further processing and oleomargarine|
|27||Dressings and condiments (including mayonnaise) salad dressing and vinegar|
|28||Spices including salt; flavors and extracts|
|29||Soft drinks and water|
|31||Coffee and tea|
|33||Chewing gum and candy|
|34||Chocolate and cocoa products|
|35||Pudding mixes not cooked prior to consumption, gelatin products|
|36||Syrups, sugars and honey|
This includes the following foods that would normally be subjected to a process lethal to Salmonella between the time of sampling and consumption. Examples are as follows:
|PRODUCT CODE||FOOD ITEM|
|02||Whole grain, processed grain and starch products for human use|
|04||Macaroni and noodle products|
|16||Fresh and frozen fish; vertebrates (except that eaten raw); fresh and frozen shellfish and crustaceans (except raw oysters and raw clams for consumption); other aquatic animals (including frog legs)|
|24||Fresh vegetables, frozen vegetables, dried vegetables, cured and processed vegetable products normally cooked before consumption|
|26||Vegetable oils, oil stock and vegetable shortening|
|35||Dry dessert and pudding mixes that are cooked prior to consumption|
|37||Frozen dinners, multiple food dinners|
|45-46||Food chemicals (direct additives)|
Each sub will consist of a minimum of 100 gm (approx 3.53 oz). The usual subsample is a consumer size container of a product. Subsamples should be obtained at random to insure that the total sample is representative of the lot. When a lot consists of identifiable subdivisions (e.g., different codes), sub samples should be obtained from subdivisions in the proportion that the subdivisions are to the whole lot.
More than one subsample may be collected from large institutional or bulk containers when the number of sub samples required exceeds the number of containers in the lot. A subsample will consist of more that one container when the lot consists of containers smaller than 100 gm (e.g., 4 - 25 gm containers is a subsample).
When a sample is collected by transferring it to sample containers, a sample control must be submitted which consists of an empty sample container that is exposed to the same conditions under which the sample is collected. See IOM 184.108.40.206 and 220.127.116.11 on controls. Use aseptic technique when sampling from bulk containers.
The following sample sizes also apply to the finished product portion of in-line samples when analyzed for Salmonella. Each subsample will consist of at least 100 gm (approx 3.5 oz).
The 702(b) [21 U.S.C. 372(b)] portion is included in these subsamples, however all subs must be collected for proper analysis. Do not reduce the number of subsamples when collecting import samples.
FOOD NUMBER OF SAMPLE
|NUMBER OF SAMPLE |
Submit all samples collected to your district's microbiological servicing laboratory unless directed otherwise by your supervisor or assignment. See IOM 18.104.22.168.