Date: March 27, 2012

Subject: Assignment to Collect Samples of Poultry Feed (Layers, Broilers and Turkeys) and Analyze Them for Salmonella

OBJECTIVE

1. To determine the prevalence of Salmonella in the poultry feed samples collected under this assignment
2. To determine the serotype/genetic fingerprint/antimicrobial susceptibilities of Salmonella isolates found in the poultry feed samples collected under this assignment.

BACKGROUND

FDA’s Center for Veterinary Medicine (CVM) is concerned about animal feed and feed ingredient serving as vehicles for transmitting Salmonella serotypes that are pathogenic to the animal consuming the animal feed or feed ingredient. This assignment will provide information on the prevalence of Salmonella and the serotype/genetic fingerprint/antimicrobial susceptibilities of each Salmonella isolate found in the poultry feed samples. In the future, CVM may issue assignments to collect information on the prevalence of Salmonella and the serotype/genetic fingerprint/antimicrobial susceptibilities of each Salmonella isolate found in animal feed for other animal species.

ASSIGNMENT

In this assignment, Center for Veterinary Medicine (CVM) will focus on poultry feed for layers, broilers, and turkeys as CVM has concerns that poultry feed may contain Salmonella Pullorum, Salmonella Gallinarum, and Salmonella Enteritidis that are pathogenic to poultry.

Sample Collection

The 100 official samples of poultry feed (layers, broilers and turkeys) in this assignment can be collected at commercial feed stores, at commercial feed mills, and at feed mills supporting integrated poultry operations. Poultry feed samples in the mash form (not pelleted or crumbled) are preferable since pelleting or crumbling of the mash may kill Salmonella. The number of layer feed, broiler feed and/or turkey feed to collect are divided among the FDA regions and districts.

The state feed regulatory agency should be advised prior to collection of any poultry feed in this assignment.

This assignment can include sampling of both medicated and non-medicated poultry feed provided they are in domestic commerce. This assignment does NOT include samples collected in import status at US ports of entry.

Follow the sample collection procedures as described in the FDA Investigators Operations Manual (IOM), Subchapter 4.3, Collection Techniques: aseptic sample collection procedures as described in the IOM, Subchapter 4.3.6, Aseptic Sample; proper controls collected as outlined in IOM 4.3.6. In addition, interstate commerce should be documented; labels and labeling materials should be collected and the address and contact information about the feed manufacturers should be provided on the sample collection report (C/R).

Sample Size

For this assignment, sample size of each official sample should consist of 10 sub-samples with each sub-sample weighing approximately 200 g (7.1 oz). Each of these 10 sub-samples already includes the 702(b) portions. Therefore, there is no need to collect additional 702(b) portions per 21 CFR 2.10 (b)(3).

Please use the following guidelines when collecting samples:

• Aseptically collect 5 sub-samples from different sections of each of 2 randomly selected containers or storage units of the feed for a total of 10 sub-samples.
• If all of the feed is in one container or storage unit, aseptically collect all 10 sub-samples from different sections of the container or storage unit.
• Identify size of lot and any code numbers or lot numbers utilized including any expiration dates.

Sample Shipment

Refer to IOM subchapter 4.5.5 for sample shipment instructions. Samples are to be shipped via ground delivery to a lab determined by the National Sample Distributor (NSD) program. Please ensure that samples are packed appropriately to avoid damage to the sample. The laboratory should be notified of the impending shipment.

Sample Analysis

ORA servicing laboratories will analyze the 100 official samples of poultry feed for Salmonella. AOAC Official Method 2004.03 [Determination of Salmonella in Foods by VIDAS (SLM) Immunoassay], an enzyme-linked immuo-fluorescent assay, is to be used as the screening method for this assignment. Refer to procedures outlined in the BAM on line, Feb. 2011, chapter 5, Salmonella for the confirmatory method to use in this assignment.

Aseptically weigh approximately 37.5 g (~ 1.3 oz) from each of the 10 sub-samples to form a 375 g (13.2 oz) composite sample for Salmonella analysis.

The servicing laboratory will reserve approximately 75 grams (~ 2.6 oz) or more from each of the 10 sub-samples for use as the 702(b) portion. Each of these 10 sub-samples already includes the 702(b) portions so there is no need for the field to collect additional 702(b) portions per 21 CFR 2.10 (b)(3).

If the sample is positive for Salmonella, the servicing lab will send each Salmonella isolate to ARL or DEN-LAB for serotyping, and retain the duplicate Salmonella isolate in the laboratory. All serotyped Salmonella isolates will be sent to DEN-LAB for antimicrobial-susceptibility testing.

Laboratories confirming the presence of Salmonella in feed should assign LC-2 to the findings. Laboratories performing the serotyping of the Salmonella isolates should assign LC-3 to findings of Salmonella Pullorum, Salmonella Gallinarum, and Salmonella Enteritidis. All other serotypes should be assigned LC-2 and CVM will review the significance of each of them.

REGULATORY STRATEGY

The FDA’s Center for Veterinary Medicine (CVM) intends to support advisory/regulatory action against firms which are manufacturing, distributing or offering for sale any feed for layers, broilers and turkeys that are contaminated with Salmonella Pullorum, Salmonella Gallinarum, and Salmonella Enteritidis. Documentation that the poultry feed was in interstate commerce will need to be provided before FDA/CVM will support advisory/regulatory action under this assignment.

For each sample of poultry feed found to contain Salmonella Pullorum, Salmonella Gallinarum, and Salmonella Enteritidis, districts should initiate procedures to remove the contaminated feed from interstate commerce, to inform the responsible firm(s) of the need to initiate corrective action to prevent future contamination, and to recommend the issuance of a Warning Letter. In addition, within 90 days of being informed by the laboratory of the finding of Salmonella Pullorum, Salmonella Gallinarum, and Salmonella Enteritidis in a poultry feed sample, CVM will ask the district in which the manufacturing firm/importer is located to conduct follow-up investigations. These follow-up investigations will focus on the facility or facilities where the violative sample was manufactured or stored and should include a review of the manufacturing, handling and/or storage procedures/conditions; documentation of what corrections, if any, were made; and the collection of follow-up samples. Furthermore, if Salmonella Enteritidis is found in layer feed, additional follow-up investigations on the layer farms that received this feed may be appropriate.

CONTACTS

CVM – Scientific/technical questions related to this assignment: Dr. Xin Li, 240-453-6863, email: xin.li@fda.hhs.gov

CVM – Compliance questions related to regulatory strategy:
Primary contact -- Dr. Linda Benjamin, 240-276-9204, email: linda.benjamin@fda.hhs.gov  
Secondary contact -- Ms. Kathy Hemming-Thompson, 240-276-9216, email: kathy.hemming@fda.hhs.gov

/signed/
Daniel G. McChesney, Ph.D.
Director, Office of Surveillance and Compliance