CFSAN/Office of Compliance
May 1, 2007
|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.
|Goals and Objectives||3-4|
|Products/Ingredients of Interest||4|
|Inspectional Activities (General)||5|
|Sampling Instructions (General)||9|
|Sample Collection (Product Code Information)||10|
|Sample Size and Shipment||11|
|General Sample Receipt (by Laboratories)||11-12|
|Regulatory/Enforcement Action (FDA Product)||13|
|Data/Time Reporting for FDA/State--PAC Codes||14-15|
|Melamine MSDS||Attachment B|
|ALERT Background Information||Attachment D|
|PSA Background Hand-out||Attachment E|
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.
The overarching goals in this assignment serve to:
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 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.
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.
Phase 1, beginning 05/02/07:
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.
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).
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:
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
Districts should prioritize inspections in the order of importance with the following criteria in mind:
* This criteria may expand or change in future phases of the PSA
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:
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:
The PNC will notify the District Director and other district contacts of the request to sample. The field staff should proceed as follows:
When available for 801(a) review when the cargo arrives, as directed by the PNC, conduct a reconciliation examination of the shipment and collect the requested sample in import status following all normal procedures. The district office should coordinate sampling with local CBP counterparts.
If the line has already been May Proceeded by the entry reviewer on a PNC directed assignment, rescind the May Proceed. If the shipment destination is within the District's coverage, contact the filer or consignee and notify the importer that the shipment must be held at destination.
If the shipment is unavailable at the port or at destination, the PNC may recommend that the next available shipment associated with the targeted party be examined and sampled at the border rather than issuing a Notice of Redelivery. Appropriate OASIS PN and 801(a) screening will be loaded to ensure these targeted shipments are held and available for sampling.
If the opportunity is such that you are able to share relevant materials, please share the following:
FDA investigators/inspectors are asked to complete inspections of establishments that manufacturer, process, store or distribute products of interest as described below.
Districts will complete the following for each entity visited as part of the assignment:
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:
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:
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.
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.
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:
Corn Meal and other Milled Corn Products, Product Code:
Rice Flour, Product Code
Processed (packaged) Rice, Rice Meal and Other Milled Rice products, Product Code:
Wheat Flour, Product Code:
Wheat Meals and Other Milled Products, Product Code:
Other Flours and Milled Products from Grain Bean, and Vegetable Products, Product Code:
Vegetable Protein Products (Simulated Meats), Vegetable Protein Meat Extenders, Product Code:
Non-Medicated Animal Feeds, Ground Grains for Animals, Product Code:
Non-Medicated Animal Feeds, Animal Feeds, n.e.c., Product Code:
Byproducts for Animal Foods, Corn Products and by-products, Product Code:
Byproducts for Animal Foods, Rice Mill by-products, Product Code:
Byproducts for Animal Foods, Oilseed by-products, Product Code:
* Additional ingredients or finished products are likely to be added during the course of the assignment.
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:
Sample Receipt by FERN Labs:
Samples should be screened as indicated above and then provided to the analysts, indicating the priority of the samples.
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,
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).
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 #:
Matrix Specific Sample Preparation Instructions:
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.
State FERN Laboratories:
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.
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.
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.&
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.
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:
If samples are taken, what will happen to the analytical results?
All press inquires should be directed to the FDA's Press Office at (301) 827-3414.