FY 2007 Protein Surveillance Assignment—DFPG #07-20

Memorandum

Date:	May 1, 2007
From:	Team Leader, Microbiological and Dietary Supplement Safety Team Field Programs Branch, HFS-615 FDA/CFSAN/Office of Compliance/Division of Field Programs and Guidance
Subject:	FY 2007 Protein Surveillance Assignment—DFPG #07—20—ORA Concurrence #2007050101
To:	All FDA RFDDs, DDs, DIBs, DCBs, Lab Directors, ORO Division Directors Participating State/Local Health Agencies Center for Veternary Medicine (CVM) Prior Notice Center Directors, Participating FERN Laboratory Directors

Note: Material that is not releasable under the Freedom of Information Act (FOIA) has been redacted/deleted from this electronic version of the program. Deletions are marked as follows: (#) denotes one or more words were deleted; (&) denotes one or more paragraphs were deleted; and (%) denotes an entire attachment was deleted.

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Protein Surveillance Assignment
Quick Reference Guide

Title	Page Number
Background	3
Goals and Objectives	3-4
Timeline	4
FDA Role	4
State/Local Role	4
Products/Ingredients of Interest	4
Inspectional Activities (General)	5
Safety Precautions	5
Implementation	6-8
State/Local Implementation	8
Traceback/Traceforward Information	9
Sampling Instructions (General)	9
Sample Collection (Product Code Information)	10
Sample Size and Shipment	11
General Sample Receipt (by Laboratories)	11-12
Analytical Section	12-13
Regulatory/Enforcement Action (FDA Product)	13
Regulatory/Administrative Follow-up	14
Data/Time Reporting for FDA/State--PAC Codes	14-15
Contact List	15
Priority (FDA)	15
#	#
Melamine MSDS	Attachment B
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ALERT Background Information	Attachment D
PSA Background Hand-out	Attachment E
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#	#
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BACKGROUND

In March/April 2007, FDA began investigating pet deaths in the U.S. associated with the consumption of pet food contaminated with melamine.  Shipments of both wheat gluten and rice protein imported from China have been implicated as part of this 2007 investigation.  In addition, corn gluten contaminated with melamine used in pet foods has been implicated during the same period with dog illnesses and deaths in South Africa.  In light of the pet food recalls involving the presence of melamine in wheat gluten, rice protein concentrate, and corn gluten, FDA is taking this proactive measure to help ensure the safety of the U.S. food and feed supply.  The assignment focus will be on 1) imported protein extracts and finished products (added later) in domestic status, and 2) PNC directed assignments for ingredients/products of interest in import status (with the exception of vegetable protein concentrates, which are covered under Import Alert 99-29).

It is important to note that there are no indications that melamine has been added to ingredients other than those used in the recalled pet foods. However, in the interests of raising awareness and being proactive, it is important to undertake this assignment. 

GOALS

OVERARCHING GOALS

The overarching goals in this assignment serve to:

1. Examine, through inspection and sample analysis, ingredients and finished products imported from China (or transshipped from China) for the presence of melamine and other contaminants,
2. Launch an educational campaign to make the food and feed industry more aware of the issues in light of the recent pet food recalls involving wheat gluten, rice protein concentrate and corn gluten; and  
3. Deter intentional contamination of food and feed through heightened and targeted preventive activities at various food and feed manufacturers who use a variety of protein ingredients to produce their products.

OBJECTIVES

1. Perform limited scope inspections (as described below), reconciliation exams, and traceforward information collection at selected firms.   Inspections will be conducted to heighten food/feed defense awareness by:
   • discussing the ALERT initiative with management of the firm emphasizing on the "A"- Assuring the safety and security of the ingredients and products by knowing the suppliers as mentioned in the standardized presentation that will be provided as an attachment;
   • encouraging management to utilize the preventive measures provided in the FDA's guidance documents and identifying opportunities for improvement or enhancement of the firm's food/feed defense approach, as compared to those recommended in the guidance documents; and
   • identifying firms' ability to provide a list of the immediate suppliers, transporters and consignees of the assigned products; and
2. Collect and analyze domestic-import and imported samples of the "assigned products under the FY2007 Protein Surveillance Assignment".  Samples will be collected as directed in the assignment or in additional assignments issued by the Prior Notice Center (PNC).

TIMING OF THE ASSIGNMENT

The inspectional and sampling activities identified in this assignment are planned to begin on May 2, 2007.  The anticipated time period is 30 days, but may be shortened or lengthened depending on developing circumstances. 

FDA (CFSAN, CVM, ORA) ROLE

FDA has the lead role in constructing this assignment.  The Center for Food Safety and Applied Nutrition (CFSAN) worked with the Center for Veterinary Medicine (CVM) to draft the assignment.  Office of Regulatory Affairs (ORA), in addition to its active role in planning this assignment, also serves as the liaison to the state and local organizations.  The Prior Notice Center may be directing field examinations, import sample collections, and inspections based on specific intelligence and current targeting data.  ORA field personnel will conduct all FDA directed inspections and sample collections.  Although not anticipated at this time, ORA field laboratories, as part of the Food Emergency Response Network (FERN) may conduct laboratory testing as directed, if deemed necessary during the course of the assignment.

STATE/LOCAL ROLES

Through contractual and volunteer mechanisms, State and local regulators may be tasked with completing specific tasks during the course of the assignment.  Tasks may include:  completion of routine FDA inspections and sample collections, and completion of inspections and sample collections as defined in this assignment.  FERN Chemistry Cooperative Agreement labs will be participating in the assignment by completing requested analyses.

INGREDIENTS/PRODUCTS OF INTEREST

Phase 1, beginning 05/02/07:

• Selected Ingredients (imported from China)-focusing on specific forms of wheat, corn, rice, and soy  (refer to Sample Collections below for specific forms, based on relevant produce codes, to be sampled).

The size and scope of the assignment may change as we move forward.  Additional protein ingredients, finished products that contain those proteins and additional countries of origin may be added.  Additional phases capturing these expansions/changes will be issued in the future.

INSPECTIONAL ACTIVITIES

Under this assignment FDA and State regulators will perform limited scope inspections, including food defense activities, reconciliation exams, sample collections, and determining whether the firm has the ability to identify immediate suppliers, transporters and consignees of the assigned products.  Domestic firms were identified for coverage using FACTs, Oasis, and PNC data.  The districts should prioritize inspections/sample collections using criteria provided in the "Domestic" subsection which follows.  All inspections conducted under this assignment should be counted toward the High Risk Performance Goals for CVM and CFSAN.  For any facilities not identified as high risk, under the "pet food" PAC, enter a high risk code and then end date it.

At the beginning of the inspection, discuss with firm management the purpose of the food or feed inspection.  Please assure firm management that there is no specific threat information that these products are, in fact, contaminated or will be contaminated. 

Attachment D contains background information regarding ALERT that should be reviewed by FDA inspectors prior to the inspection. When disseminating and discussing this information, please place emphasis on "A"- Assuring the safety and security of the ingredients by knowing the suppliers.  Investigators should supply  ALERT cards and brochures with industry.  Investigators may also provide Attachment E, "Protein Surveillance Assignment Stakeholder Hand-Out" to each firm as this document summarizes the purposes of this assignment.

Due to the nature of this assignment, any positive samples that might be identified must be handled strictly according to protocol.  Results or information may not be shared outside of the official channels.

Regions should identify a Regional Coordinator for this assignment who is responsible for tracking assignment accomplishments and submitting information as necessary to the Emergency Operations Center (EOC).

SAFETY PRECAUTIONS

Melamine and additional related contaminants have been found in concentrations of up to 20% in analyzed samples.  The MSDS for pure melamine is attached as Attachment B and includes warnings "to avoid breathing dust, avoid contact with eyes, skin and clothing".  Chronic exposure may cause cancer or reproductive damage.

The following personal protective equipment is recommended to prevent such exposures: 

• a minimum of the half-face, face-sealing respirator (P100) with HEPA filter cartridge (wipe or rinse the respirator facepiece w/o filter cartridge before reuse)
• face sealing goggles (vented goggles will be protective) wipe or rinse before reuse
• disposable suit (remove and bag prior to entering vehicle)
• either disposable shoe covers or wipe/brush shoes prior to entering vehicle
• disposable gloves

Pregnant women should not perform this assignment.

For questions, contact your Regional or District Industrial Hygienist #

Also refer to the Safety Precautions information in Investigations Operations Manual (IOM), section 1.5. at: http://www.fda.gov/ora/inspect_ref/iom/ChapterText/1_5.html#SUB1.5

IMPLEMENTATION

FIRM PRIORITIZATION CRITERIA*

Districts should prioritize inspections in the order of importance with the following criteria in mind:

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* This criteria may expand or change in future phases of the PSA

FDA

• IMPORTS

For the initial phase of this assignment other import examinations and sample collections are to be prioritized and directed by the Prior Notice Center as follows:

1. Wheat, Rice and Corn Products Transshipped from China through other countries:  Sampling of wheat, rice, and corn protein products suspected of being imported from China to Canada, Mexico or other foreign countries and transshipped to U.S.
   • These assignments will be issued as PNC Directed Sampling Assignments (unless identified by field Investigators during field examinations) and collected in Import Status for cause.
2. Soy and other Protein Derivatives (CFSAN to determine priorities for other proteins) and Raw Materials from China:  Sampling of soy and other protein derivatives and raw materials from CFSAN list imported from China.
   • Higher risk shipments identified by PNC will be referred to the field as PNC Directed Sampling Assignments and collected in Import Status for cause.
3. Wheat, Rice and Corn Products from Non-China Sources:  Sampling of wheat, rice and corn protein products imported from countries other than China.
   • Higher risk shipments identified by PNC will be referred to the field as PNC Directed Sampling Assignments and collected in Import Status for cause.

As noted above, in some instances, the Prior Notice Center review process may result in a recommendation via a directed assignment, to the District Director identifying lines or future shipments that should be sampled as part of this supplemental assignment.  For PNC directed assignments,  the following instructions are applicable:

• DOMESTIC

FDA investigators/inspectors are asked to complete inspections of establishments that manufacturer, process, store or distribute products of interest as described below.

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Districts will complete the following for each entity visited as part of the assignment:

• The investigator should conduct at least one reconciliation examination during each establishment inspection.  The examination is to be conducted on "assigned ingredients/products of interest."  Where possible, these examinations should be performed on products as they are received by the firm.  Follow guidance in IOM 5.4.1.4.3 to IOM 5.4.1.4.5 for domestic reconciliation exams.
• Investigators may also provide Attachment E, "Protein Surveillance Assignment Stakeholder Hand-Out" to each firm as this document summarizes the purposes of this assignment.
• Disseminate and discuss ALERT information (as seen in Attachment D) focusing on the "A" in the acronym
• Information resulting from discussions regarding the ALERT presentation, or to identify/record any security observations or recommendations will not be documented as part of the inspection paperwork. Please record that the ALERT information was presented and discussions regarding food defense were held.
• Collect Trace information as described in the Traceback/Traceforward section below
• Remind establishments about the importance of taking steps to assure raw materials are from a safe and secure source, and are not adulterated. 
• Collect a sample of ingredient(s).product(s) #.
• Collect a sample(s) as directed under Sampling Instructions.
• Remind firms that they should be testing incoming ingredients and that the method for Melamine is posted at website:  http://www.fda.gov/cvm/MelaminePresence.htm.
• If your inspection reveals any product of interest labeled:  #, please collect a sample and ask the firm to hold the product.
• If your inspection reveals any product that appears to be transshipped from China (e.g. labeled in Chinese, but records indicate from a country other than China), collect a sample and ask the firm to hold the product.

State Contracts

All State Contract inspections will be issued and coordinated through the State Program Coordinators.  These assignments will be assigned under the existing contracts, so state resources are already allocated.  States under FDA contract may be asked to complete the following:

• Conduct routine food and feed safety inspections/sample collections to cover backlog of routine food and feed safety work, and
• Conduct domestic facility inspections, reconciliation exams (see IOM sections 5.4.1.4.2 to 5.4.1.4.4 at http://www.fda.gov/ora/inspect_ref/iom/ChapterText/5_4.html#5.4.1.4.2  ) and sample collections that are part of this assignment as described above in the FDA section, if requested by the district.   When conducting an inspection/sample collection of this type, please follow the instructions given in the FDA section above.  Note safety precautions referenced.

State/Local Volunteers

For those that wish to participate, it is suggested that State and local health agency inspectors/ investigators and feed control investigators complete the following as part of their regularly scheduled workload:

• Determine if ingredients or products of interest are processed/manufactured/stored/sold/served at the facility,
• Disseminate and discuss ALERT information (as seen in Attachment D),  focusing on the "A" in the acronym,
• Review the firm's capacity to provide trace back and trace forward information on finished products and associated raw materials, and  
• Remind establishments about the importance of using known, appropriately licensed ingredient suppliers, packaging operators, and contract manufacturers,
• Please notify your FDA District Office when an assessment related to this assignment is conducted, and advise if further follow-up may be appropriate.

TRACE BACK/TRACE FORWARD RECORD COLLECTION

Districts should collect one forward, one back traceback/traceforward information for products of interest encountered during each inspection. Traceback should include labeled manufacturer(s), supplier(s), quantity received/dates.  Ttrace forward information should include a list of consignees and quantity/ship dates.   Full traceback information should be collected for any products encountered during this assignment when (a) appear to be from the known problem chinese suppliers or known distributor, (b) the reconciliation exam discloses a need for a for cause sample collection, or ( c ) when requested by the Protein Assignment Workgroup or the Prior Notice Center.   Determine if the firm is aware if any of it's consignees may be incorporating the product of interest into foods for at risk populations (infant formula, baby food, adult liquid meal supplements, etc.) and obtain any other pertinent information.  Electronic copies of spreadsheets to assist in recording and reporting the information will provided to the districts separately.  If firms have a large number of consignees, request that they provide a spreadsheet, if possible.  Submit the completed spreadsheets electronically to the Protein Surveillance Assignment workgroup (CFSAN/DFI/PNC) for review; at .   

NOTE:  For this surveillance assignment, ORA and CFSAN do not expect Districts to demand records under the record keeping authority of the BT Act.  If a firm refuses to provide the needed information AND the reconciliation exam and/or other findings do not directly link the product(s) of interest to the known suppliers or distributors, then document the refusal and close out the assignment.  If the findings or reconciliation exam to directly link a product of interest to the know suppliers or distributors, please contact your ORA headquarters contact immediately for further instructions.

SAMPLING INSTRUCTIONS

The samples collected as part of this assignment are not considered regulatory samples, and there is no need for a 702b portion, or IS documentation.  However, if your inspection/reconciliation exam uncovers unexplainable inconsistencies, including any evidence of possible transshipment of product from China, or a possible food safety issue, collect a "for cause" sample.  "For Cause" samples should be processed by the usual mechanisms through your regular FDA servicing laboratory.

Inspectors should follow the agency's standard procedures for maintaining the integrity of the sample and for payment for samples.  Include a copy of sample collection report with the sample that is submitted to your assigned FERN lab and contact your FERN laboratory to notify them when shipment(s) of sample(s) occur(s).

Sampling information for the assignment is provided below.  An estimated 150-200 samples will be collected each week over the course of the assignment.  

• In general, one sample should be collected from each lot of ingredient/product of interest available, up to five lots, of the ingredient. 
• When collecting a sample from a bulk container, collect the sample aseptically to prevent contamination of the bulk product. Refer to FDA Investigations Operations Manual (IOM) Chapter 4.3.6 "Aseptic Sample" at http://www.fda.gov/ora/inspect_ref/iom/ChapterText/4_3.html#4.3.6
• An acceptable primary container would be plastic whirl-pack or zip-lock bags.  If there are no open containers of these products and suitable sized un-opened containers are available, these may be submitted in lieu of sampling containers.
• Some sampling situations may require specialized equipment or procedures.  In these cases it is acceptable to have a representative of the firm collect the sample using the firm's sampling equipment, in the presence of the investigator. The name of the individual and the procedures followed must be documented in this case.  
• Ship ingredients at ambient temperature.
• FDA investigators may review Attachment C for collection reporting instructions

SAMPLE COLLECTION*

Products to be sampled:

Only wheat, corn, rice, and soy in any one of the following forms (#, any/all of the following forms are suitable for sampling under this assignment):

Whole grains, Product Code:

• 02A[01]
• 02A[05]
• 02A[09]
• 02A[10]

Corn Meal and other Milled Corn Products, Product Code:

• 02B [] all products except hominy [06]

Rice Flour, Product Code

• 02C[01]
• 02C[02]

 Processed (packaged) Rice, Rice Meal and Other Milled Rice products, Product Code:

• 02D[01]
• 02D[02]
• 02D[03]
• 02D[05]

Wheat Flour, Product Code:

• 02E [] all products

Wheat Meals and Other Milled Products, Product Code:

• 02F [] all products

Other Flours and Milled Products from Grain Bean, and Vegetable Products, Product Code:

• 02G[08]

Vegetable Protein Products (Simulated Meats), Vegetable Protein Meat Extenders, Product Code:

• 18E[] all products

Non-Medicated Animal Feeds, Ground Grains for Animals, Product Code:

• 70A[02]
• 70A[04]
• 70A[07]
• 70A[09]

Non-Medicated Animal Feeds, Animal Feeds, n.e.c., Product Code:

• 70Y[99]

Byproducts for Animal Foods, Corn Products and by-products, Product Code:

• 71G[02]

Byproducts for Animal Foods, Rice Mill by-products, Product Code:

• 71I[02] meal, rice mill byproducts, n.e.c.

Byproducts for Animal Foods, Oilseed by-products, Product Code:

• 71L[07]
• 71M[01]

* Additional ingredients or finished products are likely to be added during the course of the assignment.

Sample Size

Collect 1-450 g (1 lb.) sample from open containers.  May substitute a similarly sized sealed product if necessary (Do not collect bulk totes or pallets)

Sample Shipment to FERN Labs:

• Ship samples to FERN laboratories as directed in Attachment A. Laboratory Addresses and Points of Contact can be found in this Attachment.
• Please notify the appropriate FERN servicing laboratory when the shipment is prepared and ready to be sent FEDEX overnight.  Laboratory Points of Contact can be found in Attachment A.  You may contact the lab directly or via email.
• Ship samples at ambient temperatures.  Ship samples by FedEx overnight delivery.
• When samples are shipped to a laboratory, a hard copy of the collection report must accompany the shipment.
• Sample Custodians\POC (point of contact) must be notified prior to shipment of samples to provide the shipping details. Instructions for shipping to State FERN laboratories can be found below. When scheduling sample collection and shipment, ensure that laboratory sample receipt date will not fall on Friday, Saturday, or Sunday (or state that samples may be held to prevent weekend overtime work).

Sample Receipt by FERN Labs:

• For FDA laboratories, upon receipt, screen all samples for excessive gamma radiation emission using a wide area monitor, a hand held assay meter, or both.  Samples should be screened as per local procedures set up by the testing District using the SOP reference cited below:
  • ORA-Wide Standard Operating Procedures: Gamma Testing of Food Using Wide Area and Hand Held Detectors. (available in PDF).
• State FERN laboratories should follow their internal procedures for sample screening.

Samples should be screened as indicated above and then provided to the analysts, indicating the priority of the samples.

ANALYTICAL:

General:

• Use the "GC-MS Screen for Melamine and Cyanuric Acid" #. The methods can be found at https://www.elexnet.com.

  Please note: The methods to be used for this assignment are not fully validated for all commodities of interest. ORA and CFSAN are pursuing further validation studies to fill any gaps in the validation schemes. If the laboratory experiences matrix complications or other complications, contact the POC #.

For Chemical Analyses:

TABLE 1. Chemical Sample Testing per Assigned Product

Samples collected for chemical analysis should be analyzed according to the following table with "X" indicating the required analyses:

AGENTS	Method Title	Ingredients (Wheat Gluten, Corn Gluten, Rice Protein Concentrate, Soy Protein Concentrate)
Melamine	GC-MS Screen for Melamine and Cyanuric Acid	X (100% of samples)
Cyanuric Acid	GC-MS Screen for Melamine and Cyanuric Acid	X (100% of samples)
Ammeline	GC-MS Screen for Melamine and Cyanuric Acid	X (100% of samples)
Ammelide	GC-MS Screen for Melamine and Cyanuric Acid	X (100% of samples)
#	#	#*

* #.

Laboratories should analyze samples for the agents identified above when possible (dependant on availability of agent standards).  If a laboratory does not possess the standard for an agent or agents, do not include that agent in the analysis (and note the exemption in the results reporting for the sample).

SAMPLE PREPARATION and ANALYSIS:

Purpose:

This document provides additional information for sample preparation of specific matrices to be analyzed using the GC-MS Screen for Melamine and Cyanuric Acid method #:

General Comments:

• Samples should be shipped at ambient temperatures.

• Composites should be stored in a refrigerator after preparation.

• All references to water are reverse osmosis deionized (RO DI or DIW) water or equivalent.

Matrix Specific Sample Preparation Instructions:

• Please refer to the "GC-MS Screen for Melamine and Cyanuric Acid" # and any supporting documentation in eLEXNET for additional instructions and sample preparation information.  The methods and supporting information is posted in eLEXNET in the Interim FERN Chemistry Methods Journal.
• If screening results indicate the possible presence of toxic industrial chemicals not defined above, inform the FERN National Program Office (NPO).  The NPO will determine what, if any, additional follow-up procedures are necessary.
• FERN NPO: orahq.fernnpo@fda.hhs.gov, #

REGULATORY/ENFORCEMENT ACTION for FDA Regulated Products

• Due to the fact that positive results have been found in pet food, there may be potential for finding additional positive results in the course of this surveillance assignment.  We ask that investigators and laboratories use a degree of discretion and follow the procedures carefully for reporting of positive results.  No results should be shared outside of the prescribed reporting procedure.
• Evidence of tampering, counterfeiting, or suspicious activities related to an adverse findings from a reconciliation examination should be immediately relayed to the FDA Emergency Operations Center (301-443-1240). Refer to IOM 970.
• If significant food or feed safety concerns are raised during the course of a directed food or feed defense inspection, follow the guidance in the appropriate Compliance Program.

REGULATORY/ADMINISTRATIVE FOLLOW-UP (FDA regulated products):  FERN LABORATORY FOLLOW-UP

Due to the fact that positive results have been found in pet food, there may be a greater potential that we could find additional positive results in the course of this surveillance assignment.  We ask that investigators and laboratories use a degree of discretion and follow the procedures carefully for reporting of positive results.  No results should be shared outside of the prescribed reporting procedure.

Samples with preliminary results that do not rule out agents of interest and/or Confirmed Positive Results Reporting:

Laboratories should immediately report any of the following findings to the FERN National Program Office.

1. a) Any "Can't be ruled out" results from the melamine, cyanuric acid, ammeline, or   ammelide testing (GC-MS);
2. b) #;

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State FERN Laboratories:

• All results should be recorded under the "SENSITIVE" side in eLEXNET Results should not be recorded in any other data recording system.
• Please follow the data entry instructions as outlined in eLEXNET.

DATA REPORTING & RESOURCES

FDA/State Inspections, Reconciliation Examinations and Sample Collections:

Because the work conducted under this assignment is an extension of the pet food contaminant/recall investigation that the agency has been expending major resources toward, we are requesting that the time expended under this assignment be reported against the special reporting PACs established for the pet food investigation, e.g., 04R853 for human food and 71R853 for animal feed.  This will assist the agency when responding to requests for resource expenditures for the pet food investigation.

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All FDA sample collection and reconciliation/field exam activity time must be reported under PAC04R853.

All State-related activity time for this assignment must be reported under PAC 03S845.

FERN/FDA Laboratories:

Labs should ensure that all food defense sample analysis is completed and results are reported within 2 working days of sample receipt in the laboratory.

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PRIORITY

This Protein Surveillance Assignment has the concurrence of CVM and ORA (ORO Concurrence #2007050101).  FDA has designated it as HIGH PRIORITY. Collections and inspections are scheduled to begin May 2, 2007.  It is requested that all samples be analyzed within two working days of receipt of samples.

/s/

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Attachments

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ATTACHMENT B-MSDS Melamine

This document is available from the ScienceLab.com web site (PDF).

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ATTACHMENT D- ALERT: The Basics

See ALERT: the Basics.

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FY 2007 Protein Surveillance Assignment Hand Out
ATTACHMENT E

BACKGROUND

• The resources and activities planned under this assignment are a proactive approach taken by the Agency to raise awareness and assure the safety of the U.S. food and feed supply, and imported products.
• The U.S. Food and Drug Administration (FDA) in conjunction with state/local colleagues is launching a food and feed protein surveillance assignment, aimed at testing a variety of protein concentrates commonly found in the U.S. food and animal feed supply for the presence of melamine and other contaminants. 
• At this time, FDA has no evidence that melamine is in human food. 
• The assignment will focus on both newly imported ingredients as well as products currently in the U.S.  Some of the protein concentrates being tested include, but are not limited to wheat gluten, corn gluten, rice protein and soy protein.
• Foods that often contain protein concentrates include breads, pasta, cereals, pizza, baby foods and formula, meal replacement beverages, protein shakes or drinks, energy bars and processed foods that use vegetable protein as a substitute for meat.
• Industry may perform its own screening for melamine and some of the associated analogs in food and animal feed.  FDA has posted the current method on its website at http://www.fda.gov/cvm/MelaminePresence.htm.
• This assignment will last for approximately 4 weeks.

How was my establishment chosen?

Your establishment was selected because it is within the jurisdiction of the inspecting agency, and your establishment manufacturers, processes, stores, or distributes the commodity of interest.

What will the inspector do at my establishment?

FDA or state inspectors/investigators will perform the following:

• Conduct routine food/feed safety inspections/protocols,
• Disseminate and discuss ALERT information,
• Request traceback/traceforward information associated with ingredients or products of interest,
• Remind establishments about the importance of using known, appropriately licensed ingredient suppliers, packaging operators, and contract manufacturers,
• Collect a physical sample of commodities of interest for analysis.

If samples are taken, what will happen to the analytical results?

• Samples collected as part of this assignment are surveillance and non-regulatory.
• Samples will be collected primarily during visits to domestic food and feed manufacturers or in the case of imports, at the point of entry.
• Samples will be submitted to the Food Emergency Response Network (FERN) laboratory for analyses and most should be available within 3 working days.

All press inquires should be directed to the FDA's Press Office at (301) 827-3414.

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