CHAPTER 2 - SAMPLING Honey - Product Inspection Manual Table of Contents 2.1 Objectives ...................................................................................................................................... 3 2.2 Scope ............................................................................................................................................. 3 2.3 Legislative Authority to Take Samples .......................................................................................... 3 2.4 References, Forms and Equipment ............................................................................................... 4 2.4.1 2.4.2 2.4.3 2.5 References ........................................................................................................................... 4 Forms ................................................................................................................................... 5 Equipment ............................................................................................................................ 5 Sampling Procedures .................................................................................................................... 5 2.5.1 Prepare for Sampling ........................................................................................................... 6 2.5.2 Select a Product to Sample .................................................................................................. 6 2.5.3 Define the Lot from Which to Draw the Samples ................................................................. 7 2.5.4 Determine the Number of Sample Units and Sizes Required .............................................. 7 2.5.5 Select Samples Randomly ................................................................................................... 8 2.5.6 Collect the Samples ............................................................................................................. 9 2.5.6.1 Bulk Honey Sampling Techniques ................................................................................... 9 2.5.6.1.1 Liquid Honey............................................................................................................ 9 2.5.6.1.2 Granulated Honey ................................................................................................... 9 2.5.6.2 Prepackaged Honey Sampling ........................................................................................ 9 2.5.7 Inspection Report ................................................................................................................. 9 2.6 Laboratory Sampling Modes .......................................................................................................... 10 2.6.1 2.6.2 2.6.3 2.6.4 2.7 Monitoring Sampling ............................................................................................................. 10 Directed Sampling ................................................................................................................ 10 Compliance Sampling .......................................................................................................... 11 Other Types of Sampling – Legal, Special or Pilot Survey .................................................. 11 Laboratory Sampling Activities and Regulatory Requirements ..................................................... 11 2.7.1 2.7.2 2.7.3 2.7.4 2.7.5 2.8 Use of Accredited Laboratories ............................................................................................ 11 Chemical Residues .............................................................................................................. 12 Composition.......................................................................................................................... 13 Microbiology ......................................................................................................................... 13 Harmful Extraneous Material ................................................................................................ 13 Laboratory Sample Submission Procedures ................................................................................. 13 2.8.1 2.8.2 2.8.3 Identify the Samples for Laboratory Analysis ....................................................................... 13 Complete the Food Product Sample Submission Form ....................................................... 14 Ship the Samples ................................................................................................................. 14 2.9 Laboratory Sample Result Assessment ........................................................................................ 15 2.10 Follow-up to Laboratory Sample Results ...................................................................................... 15 2.10.1 Satisfactory Results .............................................................................................................. 15 2.10.2 Investigative Results ............................................................................................................ 15 2.10.3 Unsatisfactory Results .......................................................................................................... 16 2.10.3.1 Unsatisfactory Monitoring Results ............................................................................... 16 2.10.3.2 Unsatisfactory Directed Results .................................................................................. 16 2.10.3.3 Product Disposition ...................................................................................................... 18 Issued: September 2012 Replaces: June 2011 2-1 CHAPTER 2 ─ SAMPLING Honey - Product Inspection Manual List of Tables Table 2.1 Product Dispositions ................................................................................................................. 18 Appendices The following documents are intended for internal use. CFIA staff can access these documents using the internal tools noted below. Appendix 2.1A: Supplementary Guide for Chemical Residues in Honey [RDIMS # 2055039] Appendix 2.1B: Specifications for Laboratory Testing of Honey [RDIMS #2075254] Appendix 2.2 LSTS Food Product Sampling Submission Form Appendix 2.3 Template Letters for Laboratory Results Satisfactory Results [RDIMS # 2053376] Unsatisfactory NCRMP Results [RDIMS #2053610] Unsatisfactory CFIA Results [RDIMS #2053687] Investigative Results - Domestic Producer with Honey within WRL [RDIMS #2054458] Investigative Results - Domestic Packer/Pasteurizer with Honey within WRL [RDIMS #2054804] Investigative Results - Importer with Honey within WRLs [RDIMS #2056364] Repeat Investigative Results within WRLs - Example for Domestic Producer [RDIMS #2056453] Unsatisfactory Results - Fumagillin [RDIMS #3224371] Appendix 2.4 Procedure to Evaluate Corrective Action Plans (CAP) [RDIMS #1564862] Issued: September 2012 Replaces: June 2011 2-2 CHAPTER 2 ─ SAMPLING 2.1 Honey - Product Inspection Manual Objectives This chapter will provide Honey Program inspectors with the following: 2.2 An understanding of the types and purpose of sampling activities conducted within the program. Guidance on how to select and collect honey samples for inspection activities and laboratory analysis. Skills to help you verify the honey industry's compliance to the regulatory requirements. Scope The Honey Program assesses the potential food safety and economic risks in domestic and imported honey through inspection and sampling activities. The major risks associated with honey are the presence of chemical residues, in particular veterinary drugs and adulteration with foreign sugars. Other reasons for sampling honey are to verify its compositional standards, declared grade and net quantity. Sampling may also be conducted to investigate complaints and as a follow-up to unsatisfactory lab results, previous recalls or suspected problems that may have become evident during a routine inspection. Honey products such as comb honey and flavoured honey are not inspected and sampled by the Honey Program unless a particular concern has been identified, as they are only regulated under the Food and Drug Regulation (FDR) and not the Honey Regulations (HR). The sampling procedures apply to products regulated by the HR sampled at federally registered establishments (packers, pasteurizers and producer-graders) and importers according to the frequencies outlined annually in the: Honey Inspection Program Activities and Frequencies - National Standard Work Plan [RDIMS # 2232734] Honey Inspection Program - Sampling Plans and Guidelines [RDIMS # 1712580] Honey non-compliant with the regulations is not eligible for sampling. Only once the regulated party provides an acceptable written corrective action plan that includes a draft label or corrects the non-compliance, the honey becomes eligible for sampling. The ultimate goal is to sample honey that is believed to be compliant to the requirements and destined for the Canadian market. 2.3 Legislative Authority to Take Samples Section 21 (1) (b) of the Canada Agricultural Products Act provides the authority for an inspector to take samples free of charge: "21 (1) For the purpose of ensuring compliance with this Act and the regulations, an inspector may, subject to section 22, enter and inspect any place, or stop any vehicle, in which the inspector believes on reasonable grounds there is any agricultural product or other thing in respect of which this Act or the regulations apply, and the inspector may: Issued: September 2012 Replaces: June 2011 2-3 CHAPTER 2 ─ SAMPLING Honey - Product Inspection Manual a) open any container that the inspector believes on reasonable grounds contains an agricultural product; b) inspect any agricultural product or other thing and take samples of it free of charge; and c) require any person to produce for inspection or copying, in whole or in part, any record or other document that the inspector believes on reasonable grounds contains any information relevant to the administration of this Act or the regulations." Honey samples must only be collected by those individuals who are designated as an inspector under the Canada Agricultural Products Act (CAPA). 2.4 2.4.1 References, Forms and Equipment References a) Acts and Regulations Honey Regulations (HR) Canada Agricultural Products Act (CAPA) Food and Drugs Act (FDA) Food and Drug Regulations (FDR) b) Honey Program References Honey Inspection Program - Sampling Plans and Guidelines [RDIMS # 1712580] Honey Inspection Program Activities and Frequencies - National Standard Work Plan [RDIMS # 2232734] Working Residue Levels (WRL) in Honey - CFIA's Questions and Answers c) Other References CFIA National Chemical Residue Monitoring Program (NCRMP) CFIA-HC Food Sampling and Testing Terminology Chemical Residues In Food Codex Standard for Honey CODEX STAN 12 Health Canada’s Guidelines for the General Cleanliness of Foods Health Canada's List of MRLs for Pesticides Health Canada's Working Residue Levels (WRL) for Antimicrobial Residues in Honey Health Canada’s WRL Table Issues Management System User Manual [RDIMS #1599661] LSTS AgriFood / Consumer Protection / Food Safety Training Guide [RDIMS #2291552] LSTS User Services Guide [RDIMS #1857345] Pest Management Regulatory Agency (PMRA) Standards Council of Canada (SCC) Issued: September 2012 Replaces: June 2011 2-4 CHAPTER 2 ─ SAMPLING 2.4.2 Honey - Product Inspection Manual Canadian Association for Laboratory Accreditation (CALA) Forms The following CFIA/ACIA forms and reports are required for sampling and most are available on the internal Forms Catalogue (This document is intended for internal use). CFIA/ACIA Forms used in the Honey Program. 2.4.3 Receipt for Samples Taken (CFIA/ACIA 4168) Inspection Report (CFIA/ACIA 0992) Laboratory Sample Tracking System (LSTS) Food Products Submission Form Equipment The equipment listed below is required for honey sampling: sampling containers (e.g., plastic jars or tubs) that are clean, dry, inert and leak proof; sample numbers as provided by the area honey specialist - monitoring samples numbers are provided annually and directed sample numbers as required; stainless steel sampling tools (e.g., trier, long handled ladle, scoop, spoon, knives, spatula, scraper); clean white laboratory coat and hairnet; disposable gloves (optional); lint-free wipes; sampling labels or permanent marker; tape yellow - official seal (CFIA/ACIA 4561); label - official seal (CFIA/ACIA 5112); packing tape, packing material (bubble wrap, shredded paper); shipping boxes/containers. Please also refer to Chapter 1 Section 1.5.3 [RDIMS #2006991] for a listing of other equipment that may be required and Appendix 1.1 Occupational Safe Work Practices, which provides a listing of personal protective equipment. 2.5 Sampling Procedures Whether samples are gathered for laboratory analysis or for other product inspection activities (e.g., grade), sampling procedures or steps outlined in this section should be followed. The results will be used to determine compliance with the Honey Regulations and any other applicable legislation. Therefore, appropriate measures must be taken to prevent contamination of the samples during handling, storage and transport to the laboratory, if applicable. If samples are improperly collected or mishandled, or are not representative of the sampled lot, the laboratory results may be inaccurate and inconclusive. Issued: September 2012 Replaces: June 2011 2-5 CHAPTER 2 ─ SAMPLING 2.5.1 Honey - Product Inspection Manual Prepare for Sampling The following in-office sampling preparations are to be performed: 2.5.2 Review the company's file described in Chapter 1 Section 1.7.2 [RDIMS #2006991] Review annual work plans in order to be prepared for the types of product sampling and other inspection activities. Have a series of laboratory sample numbers, labels and writing tools. Have appropriate supplies/equipment to clean sampling utensils in between samples. Have a clean white laboratory coat and appropriate hair covering (e.g., hairnet). Bring Inspection Report (CFIA/ACIA 0992), Receipt for Samples Taken (CFIA/ACIA 4168), Inspector ID card/badge and Detention Book. Select a Product to Sample Choose products for sampling based on the: criteria outlined in the annual Sampling Plans and Guidelines, and product inspection frequencies outlined in the annual National Standard Work Plan. However, also consider the following factors: compliance history of the product, country, establishment (registered establishment, importer or exporter); lot size; availability of the lot; import arrivals (on a regular basis, refer to the Import Retrieval System (IRS) and/or the Import Control Tracking System (ICTS)); type of honey (e.g., new product or country of origin; different grades, floral sources, container sizes); date the product was last sampled at the premises; and any other circumstance the inspector may be aware of. Note: that it is recommended to take several samples per visit, especially at regulated parties with large volumes. For monitoring sampling, always choose products where there is no suspicion of noncompliance. For directed sampling, choose targeted, suspect or specific products based on identified problem(s). For example, during an in-depth inspection, a non-approved antibiotic is observed in the establishment. In such a case, a directed sample should be taken and analyzed for all veterinary drugs instead of taking a routine monitoring sample. Issued: September 2012 Replaces: June 2011 2-6 CHAPTER 2 ─ SAMPLING 2.5.3 Honey - Product Inspection Manual Define the Lot from Which to Draw the Samples The Honey Regulations (HR) defines a lot as follows: A lot is “a uniform blend of honey in a batch or in a storage tank from which honey is drawn for processing or grading.” A “lot” is also referred to as a "production lot". It implies that each unit in the lot comes from the same blend of honey and is processed under essentially the same conditions. Therefore, each unit has the same lot number or production code. Lots are typically differentiated by logical breaks in production (e.g., different source of honey, new storage tank), but should be no longer than one day’s production. Keep in mind though, that smaller lot sizes may minimize the amount of product rejected when there are unsatisfactory test results. Note: that honey with the same lot number but packed in different container sizes are still considered to be from the same lot and only one container size is to be sampled. A shipping lot, on the other hand, may be comprised of more than one "lot number" or "production code" and is therefore not considered to be uniform blend of honey. In these cases, it is important to identify the production lots for sampling purposes. The annual Sampling Plans and Guidelines [RDIMS #1712580] prescribe the number of lots to be sampled. Each lot should be sampled separately and be prepared for sampling in such a way that the sample(s) can be taken without hindrance. If a portion of the lot has already been distributed, the remaining quantity of the lot is to be considered the sampling lot. It is recommended to sample various lots per visit especially at large packers or importers. The HR section 36.(1)(f) requires the lot number to be identified on every package and bulk container. However, if a lot number is not available on the containers, then the entire shipment or part thereof, identified by the regulated party will be considered as the sampling lot(s). Inspectors may need to educate the regulated party on lot identification to ensure that subsequent shipments have each container properly labelled including the actual lot number. It is the registered establishment’s or importer’s responsibility to demonstrate to the inspector that the identified lot number refers to a unique production code or uniform blend of honey. The best way to achieve this is to obtain the meaning of the lot number from the regulated party. 2.5.4 Determine the Number of Sample Units and Sizes Required Issued: September 2012 Replaces: June 2011 2-7 CHAPTER 2 ─ SAMPLING Honey - Product Inspection Manual A sample is a quantity of honey taken from a lot and intended for analysis. The size of the sample depends on the tests to be carried out. A sample may consist of one or more sample units. Consult the annual Sampling Plans and Guidelines as it outlines the sample size required for the various laboratory analyses. The following numbers of units usually apply: Monitoring samples usually require 1 sample unit / lot. Directed samples usually require 6 representative sample units across the lot. If the lot number refers to a unique production code, the 6 units are to be submitted to the lab using one sample number. Indicate on the sample submission form that the six individual units should be combined. The laboratory will composite the samples for testing and retains them in case the result is suspicious and individual analysis is required. For prepackaged honey labelled with a common lot number it can be assumed that the lot number represents a unique production code and thus, it can be submitted using one sample number. For bulk honey the meaning of the lot number should be known to ensure that it represents a production code. If the lot number does not represent one production code or a lot number is not available, then the 6 samples are to be submitted individually using 6 different sample numbers. If the container sizes available for sampling differ from the sample size required, adjust the number of sample units accordingly. For example, if the required sample size is 1 unit (500 g) but only 250 g containers are available; two containers will be required from the same lot to meet the 500 g sample size requirement. Conversely, if only larger containers are available, the entire container can be sampled or a 500 g sample can be drawn by following the procedures outlined for bulk containers under Section 2.7.6.1 Bulk Honey Sampling Techniques. However, if the required sample size is 6 units x 250 g but only 500 g containers are available, 6 units must still be taken. For information on the number of sample units and size for other product inspection activities, refer to the respective chapter. 2.5.5 Select Samples Randomly To randomly select samples, each unit (container/package) in the lot has to have an equal chance of being selected, thereby excluding bias. The inspector must select the samples as randomly as possible within the lot, given the constraints of working in a production facility or warehouse environment. A true random selection of pallets, cases and/or individual packages can be achieved by using a random sampling technique. A numbering system in combination with a random number generator is one of several methods that can be used to ensure randomness. Please see section 2.4.5 of the Processed Products - Product Inspection Manual Chapter 2 for more information. Issued: September 2012 Replaces: June 2011 2-8 CHAPTER 2 ─ SAMPLING 2.5.6 Honey - Product Inspection Manual Collect the Samples When sampling products, request that a representative from the establishment assists you in retrieving bulk containers/skids of honey in the warehouse and in opening/closing the barrels /totes as required. Take all necessary steps to avoid product contamination. 2.5.6.1 Bulk Honey Sampling Techniques The following procedures are to be followed when sampling bulk honey: Wipe the top of the bulk honey barrels/totes/pails before opening. Care should be taken when removing lids and/or plastic liners from bulk honey containers so as not to contaminate the product. Remove any debris (e.g., foam, wax, bee parts) from the immediate sampling. If harmful extraneous material is found, detain product and contact your area honey specialist. Sample from below the surface and away from the side of the container to ensure the sampling tool (e.g., trier) does not damage the container, and that the sample is representative. Take the sample about 15 cm (6 inches) from the side of the container and approximately 15 cm (6 inches) deep, when possible. Seal and label each sample unit with the lot code and the sample number. 2.5.6.1.1 Liquid Honey Use a tool such as a long handled ladel for sampling; Scoop up an appropriate amount of honey indicated in the sampling plan, into the sampling container(s). Samples may also be taken directly from the honey storage tanks, in which case this should be indicated on the Sample Submission Form. Additionally, this information should be reported on the Inspection Report (CFIA/ACIA 0992). 2.5.6.1.2 Granulated Honey Remove foam and wax from the sampling surface. Use a sampling tool such as a trier to sample the product. Insert the trier into the honey at a slight angle with steady and firm pressure until it is submerged about half way. Remove and scrape the honey with a spoon or knife from the trier into the sampling container. 2.5.6.2 Prepackaged Honey Sampling 2.5.7 Ensure that the selected containers are sound and not leaking. Clearly and permanently mark each sample unit with the lot code and sample number. Inspection Report Issued: September 2012 Replaces: June 2011 2-9 CHAPTER 2 ─ SAMPLING Honey - Product Inspection Manual Summarize the inspection results on the Inspection Report (CFIA/ACIA 0992) and indicate which products and quantity were sampled for the various sampling activities. Leave a copy with the company’s representative. A Receipt for Samples Taken (CFIA/ACIA 4168) can also be provided if requested by the regulated party. 2.6 Laboratory Sampling Modes Each year the CFIA develops national laboratory sampling plans for chemical, microbiological and compositional analyses of both domestic and imported honey. To sample honey for these different analyses, three different types of sampling modes are used: monitoring, directed and compliance. 2.6.1 Monitoring Sampling Monitoring is an unbiased sampling, where samples are taken at unannounced visits. The lots are randomly selected from predefined normal-appearing populations (populations where there is no suspicion of non-compliance). Monitoring sampling is conducted to: assess human dietary exposure; perform risk assessments; monitor trends; set standards and guidelines; respond to international commitments; identify potential problems and at-risk population groups for directed sampling activities; and evaluate the effectiveness of food safety programs. The sampled lots are not held and the products are usually available to consumers before the laboratory results are known to the CFIA. When monitoring samples are found to be in violation of established limits, the issue is investigated and the honey may be subjected to further (directed) sampling. Monitoring is unbiased or random sampling designed to gather data. 2.6.2 Directed Sampling Directed sampling is biased as it targets specific populations (e.g., honey lots of specific geographical areas). Its purpose is to investigate and verify any suspected problems that may be a potential health risk or economic fraud suggested in the monitoring program or from any other sources (e.g., complaints, other government bodies). Directed sampling is investigative in nature and triggers further inspection activities in order to determine root causes of the problem. If warranted, the product is detained until test results indicate the appropriate course of action to take. The requested analysis is specific to the concern in question. The turn around time for the laboratory test results is faster than for monitoring. Issued: September 2012 Replaces: June 2011 2 - 10 CHAPTER 2 ─ SAMPLING Honey - Product Inspection Manual The results are always communicated to the regulated party. Directed sampling is biased, investigative in nature and usually leads to product detention. Education is an important element in correcting identified problems. 2.6.3 Compliance Sampling Compliance sampling is directed at specific samples suspected of not complying with regulations and guidelines governing the sale and distribution of honey products. The product is detained until the laboratory test results are available and the appropriate course of action is determined. The approach to compliance testing is referred to as in-depth sampling and follows Codex Alimentarious (latin for “food code”) specifications. The establishment of a chain of custody of the sample is essential if legal proceedings are expected to ensue. Compliance sampling and testing is a regulatory control measure to prevent the marketing or the removal from a market, a product known to be contaminated or adulterated. 2.6.4 Other Types of Sampling – Legal, Special or Pilot Survey Legal sampling, often referred to as official sampling, is undertaken for specific conditions where legal action is the anticipated follow-up action. Legal advice should be sought prior to initiating this type of sampling, and it is essential to establish a chain of custody for the sample. Other information and criteria are demanded during the collection, submission and laboratory testing of legal samples. Contact your area Enforcement and Investigation Services (EIS) officer for the correct procedures to follow when legal action is anticipated. Special or pilot surveys are information gathering studies that do not meet the criteria of the other types of sampling methods discussed above in that they are usually limited in scope and duration. Additionally, special or pilot surveys are sometimes conducted to gather information related to improving sample testing and/or collection methods, and operational activities (information on time, costs, or sample size estimates). 2.7 Laboratory Sampling Activities and Regulatory Requirements Both industry and the CFIA play an important role in preventing harmful substances (chemicals and micro-organisms) from entering the food chain, and for ensuring these products are compliant with the regulatory requirements. This section briefly covers the role of industry, the Honey Program’s laboratory sampling activities and the regulatory requirements. For other product inspection activities refer to their respective chapters for regulatory requirements. 2.7.1 Use of Accredited Laboratories As stated in Chapter 1 of this manual, it is the responsibility of the regulated party to ensure that all of the products they market are safe and meet the appropriate regulations. Issued: September 2012 Replaces: June 2011 2 - 11 CHAPTER 2 ─ SAMPLING Honey - Product Inspection Manual As part of good manufacturing and importing practices for food, manufacturers and importers are encouraged to implement a quality assurance program to help them ensure the products comply with the Canadian regulatory requirements. For laboratory testing, the CFIA recommends using laboratories accredited by the Standards Council of Canada (SCC), Canadian Association for Laboratory Accrediation (CALA) or to ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories. The following factors must also be taken into consideration when selecting a laboratory: that the analytical method applies to honey and is included in the laboratory's current scope of accreditation; and the scope of the analytical method is at least equivalent to the CFIA’s current method. Scopes of accredited laboratories showing test names, matrices and methods of analysis may be found on the SCC or CALA websites. To assist in the determination of equivalent methods, Appendix 2.1B Specifications for laboratory testing of honey [RDIMS #2075254] lists the minimum testing specifications for the most common analysis carried out on honey by the CFIA. 2.7.2 Chemical Residues The CFIA monitors the presence of chemical residues under the National Chemical Residue Monitoring Program (NCRMP). The NCRMP is managed by the Chemical Evaluation Section and supports Canada’s international agreements and obligations. It also assists the Honey Program in the recognition of trends and the identification of potential problem areas that may require directed and compliance activities. See the Chemical Residues in Food for more information. As part of the CFIA’s NCRMP, honey is monitored for the presence of chemicals from an extensive list of: veterinary drugs; pesticides and other agricultural chemicals; and environmental contaminants including heavy metals. The Honey Program also develops and conducts annual directed sampling plans for specific chemical residues and targeted honey populations that have previously been identified as being a concern. The monitoring and directed sampling plans are re-evaluated on an annual basis. Chemical residue sampling is a priority inspection activity for the honey program. Division 15 of the Food and Drug Regulations sets out the maximum residue limits (MRL) permitted for veterinary drugs and heavy metals. In addition, Health Canada and the CFIA have developed a joint policy on Working Residue Levels (WRLs) for Antimicrobial Residues in Honey (see also the CFIA's WRL Questions and Answers). Maximum Residue Limits for pesticides are prescribed by the Pest Control Products Act (PCPA) (see Health Canada's List of MRLs Required under the PCPA). For the definitions of WRLs and MRLs and further information on chemical residues please refer to Appendix 2.1A Supplementary Guide for Chemical Residues in Honey [RDIMS # 2055039]. Issued: September 2012 Replaces: June 2011 2 - 12 CHAPTER 2 ─ SAMPLING 2.7.3 Honey - Product Inspection Manual Composition The Honey Program conducts annual monitoring and directed sampling plans to verify that: 2.7.4 no sugars have been added to the honey (authenticity); and that the honey meets the compositional standards as per the Codex Standard for Honey CODEX STAN 12 and the Honey Regulations Section 8, and Tables III and IV to Schedule I. Microbiology The Honey Program on occasion, monitors for the presence of micro-organisms namely, sugartolerant, osmophilic yeasts in prepackaged honey. The purpose of this is to determine the effectiveness of the honey pasteurization process in registered pasteurizing establishments. As per the Honey Regulations, Interpretation Section, “pasteurized, in relation to honey, means treated in a registered pasteurizing establishment by the controlled application of heat so that the honey is free of viable sugar-tolerant yeasts”. Pasteurization is done to maintain the quality of liquid honey thereby extending its shelf-life and inhibiting yeast fermentation. 2.7.5 Harmful Extraneous Material Extraneous material can include many different types of materials. Of concern are materials that can be harmful because of their hardness, sharpness, size or shape. Examples of harmful extraneous materials include glass, wood-chips, insulation, metal, or sharp plastic greater than 2 mm in size. To help determine if the extraneous material is hazardous, background information should be gathered on the type of material used in the facility, facility maintenance history, consumer complaints and evidence of possible tampering. When consumer complaints or inspection evidence indicates contamination by potentially harmful extraneous material, the product may need to be detained and directed samples taken. Contact the area honey specialist for more information. Special request sample numbers must be obtained from your area honey specialist and contact the laboratory prior to submitting the samples. 2.8 Laboratory Sample Submission Procedures For samples submitted to a CFIA laboratory, the LSTS form is completed and submitted electronically. For samples submitted to a private laboratory, the LSTS form can be completed and saved electronically or an equivalent form can be used. A copy of this form should also be placed in the company's file. 2.8.1 Identify the Samples for Laboratory Analysis Each sampling plan provides the unique sample numbers to use to identify every sample. Be sure to use these pre-assigned numbers when you label or identify your samples. Each of the letters Issued: September 2012 Replaces: June 2011 2 - 13 CHAPTER 2 ─ SAMPLING Honey - Product Inspection Manual and digits in the sample number has a meaning. For example, the meaning of the sample number H8-13-CR-0001 is as follows: H8 13 CR 0001 Program Honey Fiscal year Activity Chemical Residues Sequential number from 0001 to 9999 In order to match the samples with the Food Product Sample Submission Form, clearly and permanently label each sample (including all sample units) with the following information: 2.8.2 pre-assigned unique sample number (e.g., H8-13-CR-0001); lot number; and sample unit number if more than one unit (e.g., sample 1 of 3, 2 of 3 and 3 of 3). Complete the Food Product Sample Submission Form To provide a detailed record of the product sampled and to enable trace back or follow-up activities if need be, please ensure you record the following information on the form: Submission Tab: function (domestic or import), sampling plan, laboratory; analysis information (load per plan or select tests required from list); manufacturer / registration number or importer / country of origin; responsible party; name of the sampler, submitter and expediter; exporter and foreign manufacturer for directed samples only (under ‘comment’ field); Sample Tab: sample information (sample no. and number of sample units), product information (common name; brand name; grade and colour; pasteurized, liquid or creamed; any other label claims); lot information (lot number, total weight, unit size); For more information on how to complete the LSTS submission form for the Honey Program, please see Appendix 2.2 LSTS Submission Form and LSTS AgriFood Training Guide [RDIMS #2291552]. 2.8.3 Ship the Samples Use clean, dry shipping containers and packing materials. Ensure that each sample is identified with the sample number. Seal and individually bag the sample containers as necessary and protect with packing material to ensure the integrity of the sample is maintained during transport. Ship the samples within a reasonable time period following sampling, using the most direct and cost effective route possible. Issued: September 2012 Replaces: June 2011 2 - 14 CHAPTER 2 ─ SAMPLING 2.9 Honey - Product Inspection Manual Send the samples to the attention of the Food Laboratory of Laboratory Services Division in each lab. The addresses for all laboratories are listed in the annual Sampling Plans and Guidelines [RDIMS #1712580]. Laboratory Sample Result Assessment Except for the NCRMP samples, which are mainly contracted out to private accredited laboratories, the samples are analyzed by the CFIA's laboratories. Because the NCRMP is a monitoring program managed by the CFIA’s Chemical Evaluation Section, the results from the private laboratories are sent directly to them and not to the Honey Program or respective inspector. The Chemical Evaluation Section is responsible for assessing the results and forwarding all unsatisfactory results to the appropriate program. Consequently, only unsatisfactory NCRMP results are reported to the Honey Program and inspector for followup. Results from the CFIA laboratories are reported electronically via LSTS PENMAN to the respective inspector submitting the sample and anyone else subscribed to receive the results. The bottom of the LSTS Report of Analysis will state the analytical method used, the results of analysis and the assessment decision (satisfactory, investigative, no decision or unsatisfactory), based on program assessment criteria outlined in the Annual Sampling Plans and Guidelines, for the internal report only. An external report is also available to provide results back to regulated parties. 2.10 Follow-up to Laboratory Sample Results The following are general approaches to be taken to follow-up sample results. Inspectors are to consult the annual Sampling Plans and Guidelines for more specific directions. 2.10.1 Satisfactory Results A satisfactory laboratory result means that the lot of honey is considered to be in compliance with Canadian requirements for the analysis conducted. For results from the CFIA laboratories, send a "Satisfactory Results" letter and/or the external LSTS report of analysis, only if requested by the regulated party. A template letter can be found by following the link in Appendix 2.3. For private laboratory samples from the NCRMP, satisfactory results are not reported since these results are not available to the Honey Program. 2.10.2 Investigative Results Laboratory results are assessed as investigative when veterinary drugs have been detected in honey below a recommended WRL. Investigative laboratory results (e.g., usually from CFIA laboratories) are to be reported to the establishment or importer using the appropriate template letter, which can be found by following the link in Appendix 2.3. Issued: September 2012 Replaces: June 2011 2 - 15 CHAPTER 2 ─ SAMPLING Honey - Product Inspection Manual 2.10.3 Unsatisfactory Results A laboratory result will be assessed as unsatisfactory when the compositional requirements are not met or one of the following is detected: a banned substance (e.g., chloramphenicol, nitrofuran); a substance unapproved for use in beekeeping (e.g., fluoroquinolones); a chemical residue above the MRL or WRL; or foreign sugars. For all unsatisfactory results, the inspector must inform the regulated party, the area honey specialist and open an Issues Management System (IMS) as outlined in the business rules to track all follow-up activities. For instructions on opening an IMS, please refer to the IMS User Manual [RDIMS #1599661]. 2.10.3.1 Unsatisfactory Monitoring Results Open an IMS. Bring unsatisfactory monitoring results to the attention of the responsible party. Template letters for unsatisfactory NCRMP or CFIA results are available by following the link in Appendix 2.3. Conduct a directed inspection to investigate possible root causes of the noncompliance. If any product from the same or similar lot is available, it is recommended to take directed samples and to control the product. If no similar lot is available, use the findings from the directed inspection to determine whether directed samples are required from next lots. 2.10.3.2 Unsatisfactory Directed Results Always inform the regulated party of the directed results and take appropriate action as per the annual Sampling Plans and Guidelines. All unsatisfactory results are to be brought to the attention of your area honey specialist to determine if a health risk assessment is required. Control the product and conduct an investigation as required. If the affected product is in distribution, contact the Area Recall Coordinator and follow established protocols for potential health risk situations. As part of the follow-up activities: Send a letter to the regulated party requesting appropriate product disposition and a corrective action plan (CAP). Template letters can be found by following the link in Appendix 2.3. Once you receive the CAP, review it to determine if there are any missing components or if further clarification is required. For further information please refer to Appendix 2.4 Procedures to Evaluate Corrective Action Plans [RDIMS #1564862]. Issued: September 2012 Replaces: June 2011 2 - 16 CHAPTER 2 ─ SAMPLING Honey - Product Inspection Manual Conduct a follow-up inspection within a reasonable time frame based on the estimated risk or next visit (e.g., GMP, Product Inspection) to determine if any effort has been made to implement the CAP and its effectiveness. Log all of your activities in the IMS. When repeat non-compliances from the same company have been identified, stricter enforcement actions need to be considered. Contact your supervisor and area honey specialist for direction to control the risk. Issued: September 2012 Replaces: June 2011 2 - 17 CHAPTER 2 ─ SAMPLING Honey - Product Inspection Manual 2.10.3.3 Product Disposition Product detained for an unsatisfactory result is not allowed to be sold in the Canadian marketplace. Each situation however, will be evaluated on its own merit (case by case). Table 2.1 outlines suggested options. Table 2.1 Product Dispositions Reason for Violation Suggested Options Considerations Chemical Residues Voluntary Destruction (HR 4.3) Meets provincial environmental requirements. Not allowed to be sold as food in Canada (HR 4.1(2), CAPA 17) If imported; return or remove from Canada (CAPA 30) Proof from customs (E15). Foreign government notification. Use in animal food (HR 4.2) Consult with animal health / feed / pet food program. Use for non-food applications Meets applicable requirements. Voluntary Destruction (HR 4.3) Meets provincial environmental requirements. Authenticity ─ C4 Sugars Not allowed to be sold as food in Canada (HR 4.1(2), CAPA 17) Composition ─ Grade Requirements If imported; return or remove from (CAPA 30) Use in animal food (HR 4.2) Consult with animal health / feed / pet food program. Use for non-food applications Meets applicable requirements. Voluntary Destruction (HR 4.3) Meets provincial environmental requirements. If imported; return or remove from Canada (CAPA 30) Issued: September 2012 Replaces: June 2011 Proof from customs (E15). Proof from customs (E15). Use in animal food (HR 4.2) Consult with animal health / feed / pet food program. Use for non-food applications Meets applicable requirements. Correction prior to sale Meets applicable requirements. 2 - 18