Inspections, Compliance, Enforcement, and Criminal Investigations
Sample Schedule 1: SALMONELLA SAMPLING PLAN
To determine the presence of Salmonella in processed foods and soils/water used for the growth of 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). Additionally, the soil plan is for use during on-farm investigations requiring the sampling of soil for the presence of Salmonella. 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 g (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 than one container when the lot consists of containers smaller than 100 g (e.g., 4 - 25 g 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 126.96.36.199 and 188.8.131.52 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 CATEGORY||NUMBER OF SAMPLE UNITS (SUBS)|
Submit all samples collected to your district's microbiological servicing laboratory unless directed otherwise by your supervisor or assignment. See IOM 184.108.40.206.
FARM INVESTIGATIONS – SOIL AND WATER SAMPLES
When conducting an investigation at a farm that was implicated as the source of produce contaminated with Salmonella, and the crop is exposed to soil or water splash from the soil, such as leafy greens, cantaloupes, or cucumbers, soil samples may yield important information as to how the produce was contaminated, especially if a soil amendment such as animal manure or compost was used, or if the crops on that field were rotated and animals grazed on the land previously.
Unless specific instructions were provided by the office issuing the assignment, generally 5 sub samples are collected per field, one from the growing area on each corner, and one near the center. Additional samples may be collected based on observations, such as animal incursion, areas where water may drain, portions of the field susceptible to road dust or runoff, etc. Each field should be issued a separate sample number for ease of identification and review of data. A 1000 ml whirlpack should be filled with soil from a depth of 1 to 3 inches using a sterile scoop and double bagged. Take a photograph of each area where samples are collected and indicate the location and subsample number on a diagram of the field.
Soil samples should be submitted to the lab at 4°C (39°F) or below.
If specialized equipment such as a peristaltic pump are not available, collect water in a sterile, 1000 ml Nalgene sample bottle from wells and surface water. When collecting a surface water sample, a sterile pipette with a re-usable suction bulb is recommended. Using the end of the pipette, stir the surface of the sediment until the water becomes cloudy and then collect this water. Salmonella may form a biofilm or colonize sediments and be recovered well past the outbreak period.
Water samples should be submitted to the lab at 4 °C (39 °F) or below.
Environmental samples will be submitted as Investigational Samples (INV).