CHAPTER I - GENERAL INFORMATION

1. PURPOSE
   This directive provides instructions to Office of Investigation, Enforcement and Audit (OIEA), Compliance and Investigations Division (CID) Investigators on the methods for surveillance of persons, firms, and corporations operating in-commerce who are subject to the provisions of the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), the Egg Products Inspection Act (EPIA), and the Humane Methods of Slaughter Act (HMSA), collectively referenced as "the Acts," and related laws and regulations.  FSIS is reissuing this directive to update the methods for prioritizing, conducting, and documenting surveillance activities, reorder the Attachments, update the business types (Attachment 1), update the surveillance activities and fact sheet for shell eggs (Attachments 2 and 3), update the instructions for surveillance samples (Attachment 4), incorporate a quick reference guide of Siluriformes fish requirements (Attachment 5), and clarify other information.
   
   KEY POINTS:
   • Identifies authority for in-commerce surveillance activities, including access to and examination of product, facilities, and records
   • Describes in-commerce surveillance activities, including prioritizing, preparing for, and conducting surveillance activities
   • Describes procedures for documenting in-commerce surveillance activities
2. CANCELLATION
   FSIS Directive 8010.1, Revision 5, Methodology for Conducting In-Commerce Surveillance Activities, 11/14/16
3. BACKGROUND
   1. FSIS protects the health and welfare of consumers by ensuring that meat, poultry, shell eggs, and egg products distributed in commerce are safe, wholesome, not adulterated; properly marked, labeled, and packaged; secure from intentional acts of contamination; and legally imported and properly exported.
   2. The Acts provide authority for the effective regulation of meat, poultry, and egg products and contain provisions pertaining to adulteration, misbranding, prohibited acts, imports, exports, exemptions, access and examination, recordkeeping, product detention and seizure, and criminal, civil, and administrative sanctions.  The EPIA also provides FSIS authority to ensure shell eggs packed into containers destined for the ultimate consumer meet applicable statutory and regulatory requirements.
4. ACCESS AND EXAMINATION
   1. The FMIA, PPIA, and EPIA provide FSIS personnel broad authority to conduct inspections and examinations of the premises, facilities, inventory, records, equipment, and operations of federally inspected establishments and in-commerce facilities, such as warehouses and distribution centers, subject to the Acts (21 U.S.C. 460, 604, 609, 642, 1034, and 1040).  Specifically, the FMIA (21 U.S.C. 642), the PPIA (21 U.S.C. 460), and the EPIA (21 U.S.C. 1034 and 1040) require persons, firms, and corporations that prepare, package, label, buy, sell, store, transport, or engage in other specified activities to keep records that fully and correctly disclose all transactions involved in their businesses.  These provisions also provide authorized program employees authority to access and examine the facilities, inventory, and records of these businesses; copy records required to be kept under the Acts; and take reasonable samples of inventory upon payment at the fair market value.  The FMIA, PPIA, and EPIA also provide for penalties when federally inspected establishments, in-commerce facilities, or other firms fail to comply with these requirements.
   2. Authorized program employees can use photography, under these authorities, as a technique to examine facilities, equipment, operations, inventory, records, and where necessary to copy business records.  Permission from company management to take photographs during surveillance, investigations, or other activities is not necessary (FSIS Directive 8010.3 , Procedures for Evidence Collection, Safeguarding and Disposal).
5. GENERAL
   1. Investigators conduct in-commerce surveillance activities at warehouses, distributors, transporters, retailers, ports-of-entry, and other in-commerce businesses to ensure that regulated products are safe, wholesome, and correctly labeled and packaged.  Investigators verify that the persons, firms, and corporations whose business activities involve regulated products comply with FSIS statutory and regulatory requirements when preparing, storing, transporting, selling, offering for sale or transportation, importing, and exporting such products.
   2. In-commerce surveillance activities are grouped into categories.  When conducting in-commerce surveillance activities at a business, Investigators are to perform the necessary activities for all applicable categories.  These categories include:
      1. Food Safety;
      2. Food Defense;
      3. Non-Food Safety Consumer Protection;
      4. Imported Products;
      5. Exported Products;
      6. Custom Exempt Reviews;
      7. Order Verification;
      8. Public Health Response; and
      9. Emergency Response.
      NOTE: In-commerce surveillance activities also include, as appropriate, education and outreach to provide in-commerce businesses, owners and operators, employees, and others with regulatory, food safety, food defense, and other compliance information.

CHAPTER II - PRIORITIZATION OF SURVEILLANCE ACTIVITIES

1. PRIORITIZING IN-COMMERCE SURVEILLANCE ACTIVITIES
   Investigators are to:
   1. Prioritize surveillance activities based on public health risk and impact in accordance with Agency goals;
   2. Review and consider information in AssuranceNet (ANet), such as how long it has been since the last surveillance activity, previous surveillance activity findings, and whether the firm is operating under a criminal, civil, or administrative order;
   3. Review and consider information, such as violation history, in Agency systems (e.g., the Public Health Information System (PHIS) for federally inspected establishments), and other external sources;
   4. Plan activities in a manner that allows for efficient and effective use of their time, including the use of resources available within ANet such as the interactive map and list of firms from the standard reports;
   5. Take into account logistical factors, such as travel time and distances relevant to the activities to be conducted, the proximity of the activities to be conducted, and the time it takes to conduct surveillance in one type of business versus another; and
   6. Be aware of the current threat condition level in the National Terrorism Advisory System (NTAS) and plan surveillance activities accordingly, as outlined in FSIS Directive 5420.3 ,  Food Defense Surveillance Procedures and National Terrorism Advisory System Alert Response for the Office of Investigation, Enforcement and Audit.
2. TIER STRUCTURE OF FACILITY (BUSINESS) TYPES
   1. To focus surveillance resources on in-commerce facilities that pose a greater risk to public health, FSIS established a 3-tier structure based on business type and public health impact.  This tier structure is based on five risk considerations: inherent food safety hazards, inherent food defense hazards, product volume, consumer susceptibility, and monitoring by other regulatory authorities.  ANet assigns firms to the appropriate tier based on relevant data captured by Investigators during the performance of surveillance activities.
      1. TIER 1: These businesses have the potential to significantly impact public health.  They are characterized by risk considerations such as large volumes of amenable products and significant inherent food safety or food defense hazards.  Businesses in Tier 1 are generally subject to minimal monitoring by other regulatory authorities.
      2. TIER 2: Based on their specific combination of risk considerations, these businesses have less potential to significantly impact public health than businesses in Tier 1.
      3. TIER 3: These businesses have less potential to significantly impact public health than businesses in Tiers 1 and 2 because they handle little to no amenable products, lack significant inherent food safety or food defense hazards, or are subject to routine monitoring by other regulatory authorities.
   2. Certain considerations may vary greatly among like businesses.  For example, some distributors deal with very large volumes of meat, poultry, and egg products while others primarily handle low volumes of amenable product and a few cases of shell eggs.  Further, some states have cooperative agreements with FSIS to provide regulatory oversight of meat, poultry, and egg products in intrastate commerce while other states do not.
      
      NOTE: Investigators are to refer to Attachment 1, Definitions of Business Types, for a complete list of the business types, including definitions.  
3. FACTORS USED TO DETERMINE SURVEILLANCE ACTIVITIES
   When determining where to conduct surveillance activities, Investigators are to ensure they:
   1. Conduct surveillance activities at Tier 1 facilities a minimum of once every 18 months;
   2. Conduct surveillance activities at Tier 2 facilities as workload permits, with an emphasis on firms where surveillance activities have not been previously conducted;
   3. Conduct surveillance activities, regardless of tier, when there is a need to conduct surveillance.  For example, investigation of alleged violations, foodborne illness, or consumer complaints; emergency response activities; and recall activities;
   4. Conduct surveillance activities, as necessary, to achieve FSIS goals for product sampling, special projects, or education and outreach;
   5. Conduct follow-up surveillance activities at facilities where prior surveillances revealed violations or other conditions that warrant follow-up (see Section IV of this chapter); and
   6. Conduct surveillance activities at facilities, as necessary, to verify compliance with the terms and conditions of any applicable criminal, civil, or administrative orders or other binding case disposition terms (e.g., pre-trial diversion, civil consent decree, or administrative consent decision).
      
      NOTE: Investigators are to consult with the OIEA, Enforcement Operations Staff (EOS) prior to verifying compliance with orders or other binding case dispositions. 
4. SURVEILLANCE FOLLOW-UP AND REMINDERS
   1. Investigators schedule and conduct follow-up surveillance activities at in-commerce businesses where prior surveillances revealed violations or other conditions that warrant follow-up.  Investigators are to use the following guidance to determine the timeframe for conducting the follow-up surveillance:
      1. If a violation is found during a surveillance activity, the Investigator is to follow-up within three months of the resulting enforcement action.
      2. If the first follow-up results in another violation, the Investigator is to follow-up within three months of the resulting enforcement action.
      3. If the first follow-up after any violation results in compliance, the Investigator is to follow-up again within six months.
      4. If the second follow-up results in compliance, additional surveillance activities are to be scheduled and conducted in accordance with Section III of this chapter.
      5. If a firm is operating under an order, the Investigator is to follow-up based on the terms of the order.  The Investigator is to consult with EOS regarding order verification, including any follow-up activities and any time new violations by a firm operating under an order are identified.
         
         NOTE: If the Investigator identifies other conditions that warrant follow-up during the performance of surveillance activities (e.g., sanitation or product handling concerns), they are to consult with their supervisor to determine the appropriate timeframe for follow-up.
   2. ANet provides a mechanism in the Surveillance Module to remind Investigators to conduct follow-up surveillance activities.  Investigators are to set reminders and identify the appropriate timeframes based on the information in this chapter.
      1. When Investigators document a violation, they are to set a follow-up reminder once they are notified an enforcement action has been taken.  Investigators are to set subsequent follow-up reminders, as necessary, when they document findings from follow-up surveillance activities.
      2. Investigators are to, in consultation with their supervisor, set reminders for facilities where other conditions warrant follow-up.
      3. ANet generates reminders for Investigators to conduct follow-up surveillance activities.  These are displayed on the home page of ANet with the expected follow-up date.
      4. Investigators are to complete the follow-up surveillance by the due date of the reminder.
      5. Once an Investigator conducts the follow-up surveillance, ANet will automatically clear the reminder from the system.

CHAPTER III - SURVEILLANCE METHODS

1. PREPARING FOR IN-COMMERCE SURVEILLANCE ACTIVITIES
   1. Before conducting in-commerce surveillance activities, Investigators are to ensure that they have the proper tools, equipment, and information necessary to conduct their planned activities.
      1. Investigators are to have the following government-issued tools and equipment with them or available to them:
         1. Laptop computer, printer, and scanner;
         2. Digital camera, including smartphone;
         3. Flashlight;
         4. "U.S. Detained" tags;
         5. Freezer coat;
         6. Hard hat;
         7. Related supplies, such as printer paper, batteries, and hard copies of associated forms; and
         8. Any other equipment or supplies that are necessary to effectively carry out the surveillance activities to be conducted (e.g., night vision tools, black light, ambient temperature thermometer, personal protective equipment, or product sample supplies).
      2. Prior to conducting surveillance activities, Investigators are to:
         1. Be aware of the nature of the business conducted by the person or firm that is the subject of the surveillance activity;
         2. Understand and be prepared to explain how the Acts and regulations apply to the person or firm;
         3. Review, be familiar with, and be prepared to explain, as necessary, any directives, notices, compliance guidelines, or other Agency information that are relevant to the person or firm;
         4. Review and be familiar with the compliance history of the person or firm to be surveilled (e.g., Notice of Warning letters, administrative orders, Federal court orders, State actions, or Office of Inspector General investigations);
         5. Contact FSIS personnel (e.g., EOS or Office of Field Operations (OFO)) or other Federal, State, or local agencies that have knowledge of the person or firm to be surveilled;
         6. Research the person or firm to be surveilled using the internet (e.g., Agency recall sites, State and county sites, firm website); and
         7. Review and be prepared to verify accuracy of the name, address, responsible officials, and other information for the person or firm to be surveilled.
      3. Using ANet, Investigators are to:
         1. Obtain key information in support of the surveillance activity by reviewing firm information and any associated surveillance, product control, investigation, or enforcement records, including any records documented by applicable State programs.  Firm information includes information such as business name; primary business type; additional business types (if applicable); physical address; hours of operation; product information; organization structure; and names of business owners and managing officials;
         2. Create a Firm Information record, if not currently found in ANet, so that this information will be available for future surveillance activities; and
         3. Determine whether the person or firm to be surveilled is registered, if applicable, in accordance with 21 U.S.C. 460, 643, and 644.  If the person or firm has not registered, be prepared to provide a copy of FSIS Form 5020-1, Registration of Meat and Poultry Program Handlers.
      4. Investigators are also to be aware of potential safety concerns and coordinate with their supervisor, as necessary, to develop strategies to ensure their personal safety during the surveillance activity.
2. PROCEDURES FOR CONDUCTING IN-COMMERCE SURVEILLANCE ACTIVITIES
   1. Introduction and credentials
      1. Investigators are to present their official USDA credentials (i.e., Investigator's government-issued photo identification) upon initial introduction with firm management or a responsible person.  Investigators may provide a business card along with presentation of credentials; however, a business card is not a substitute for official identification.
      2. If initial contact is with reception personnel or with an employee in a non-managerial position, Investigators are to present their credentials again upon introduction to a firm representative who holds a management position.  It may be necessary for Investigators to present their credentials to several individuals during the surveillance activity.
      3. Investigators are not to allow their credentials to leave their possession or to allow the credentials to be photocopied.  18 U.S.C. 701 prohibits photocopying of official credentials.  Investigators may allow the person to examine their credentials for identification or to document the Investigator's name and badge number.
      4. Investigators are not to present any other identification (e.g., State driver's license) or share other personally identifiable information (e.g., personal address or personal phone number) to firm management or employees.  If requested, Investigators may provide the name and business phone number of CID supervisory or management personnel.
      5. Investigators conducting surveillance at a firm whose business is open to the public (e.g., retail store or livestock auction) are not required to make immediate contact with a firm representative upon entering the firm, and therefore, do not immediately have to present their credentials.
      6. Investigators, although not required, may request that a management official, designee, or translator accompany them during the surveillance activity.  The presence of a management official or designee may help facilitate the surveillance activity.  If a management official or designee grants access to non-public areas but is unavailable to accompany the Investigator, the Investigator may proceed with the surveillance activity.
      7. If at any time Investigators feel threatened while conducting the surveillance activity, they are to leave the situation immediately, go to a secure area, and follow the instructions set out in FSIS Directive 4735.4, Reporting Assault, Harassment, Interference, Intimidation, or Threat.
   2. Determining the business type
      1. Investigators are to determine and verify the business type that is the subject of the surveillance activity.  This determination is to be made by direct observation of the type of activities being conducted at the firm and discussion with the owner, management official, or employees.  Reviewing business licenses and permits may assist Investigators in determining the business type; however, Investigators are not to rely solely on these documents.
      2. Once the business type has been determined, Investigators are to assess whether the operations being conducted comply with applicable laws and regulations from the Acts.
      3. Because the business activities may have changed since the time of the last contact or may be different from the business type listed in ANet, Investigators are to verify accuracy of firm information on file during the surveillance.  Investigators are to collect the data necessary to complete and update the Firm Information in ANet.
3. FOOD SAFETY
   1. When Investigators conduct in-commerce surveillance activities, they are to verify that:
      1. Meat, poultry, shell eggs, and egg products are wholesome and not adulterated;
      2. Sanitary conditions are such that meat, poultry, shell eggs, and egg products will not become contaminated with filth or rendered injurious to health;
      3. Hazard controls are adequate to prevent meat, poultry, shell eggs, and egg products from becoming adulterated;
      4. Meat, poultry, and egg products that are not intended for use as human food or not fit for human food are properly denatured or otherwise identified as prescribed by the regulations;
      5. Shell eggs packed into containers destined for the ultimate consumer are stored and transported in accordance with the EPIA (Attachment 2 of this directive has specific surveillance activities for shell eggs);  and
      6. All records are kept and maintained in a manner that fully and correctly discloses all transactions involved in the business activity that is subject to the provisions of the Acts.
   2. To perform the food safety component of the surveillance activity, Investigators are, at a minimum, to:
      1. Walk through the interior of the firm and examine the facilities and equipment used to prepare, store, or otherwise handle meat, poultry, shell eggs, and egg products;
      2. Examine meat, poultry, shell eggs, and egg products to identify the types of products observed (e.g., raw, ready-to-eat, shelf-stable) and determine whether the sanitary conditions and hazard controls are adequate to prevent those products from becoming adulterated;
      3. Examine records related to the meat, poultry, shell eggs, and egg products observed to determine whether those records fully and correctly disclose the transactions involving the products;
      4. Examine, when applicable, inedible meat, poultry, and egg products to determine whether those products are properly identified and denatured as prescribed by the regulations;
      5. Collect meat, poultry, and egg products samples for laboratory analysis, as necessary; and
      6. Walk the outer perimeter of the firm, when feasible, and observe the exterior structure and the grounds about the firm to determine whether the conditions are adequate to prevent meat, poultry, shell eggs, and egg products from becoming adulterated.
   3. To determine whether meat, poultry, shell eggs, and egg products are adulterated or are being held under insanitary conditions, Investigators are to seek answers to questions such as, but not limited to, the following:
      1. Meat, poultry, shell eggs, and egg products:
         1. Do the products consist in whole or in part of any filthy, putrid, or decomposed substance, or are they for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food?
         2. Do the products bear or contain any poisonous or deleterious substance that may render them injurious to health?
         3. Are the product containers (e.g., shipping container, immediate container, or packaging container) composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health?
         4. Have the products been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health?
         5. Were the shell eggs subjected to incubation?
         6. Are the shell eggs restricted eggs?  If so, the Investigator is to determine the destination of the restricted eggs for proper use and disposition.
      2. Sanitary conditions:
         1. Do the grounds around the firm provide a harborage or breeding area for rodents or pests?
         2. Does the firm maintain the building structure, both interior and exterior, in a manner to preclude adulteration or environmental contamination?
         3. Are the cleaning practices sufficient to maintain the facility in a sanitary manner?
         4. Are the utensils and equipment used in the processing and handling of edible products and ingredients maintained in a clean and sanitary condition as to not adulterate products?
         5. For firm employees who handle product, are hygienic practices sufficient to preclude products from becoming unwholesome or adulterated?
         6. Does the firm maintain records documenting pest control, sanitation procedures, repairs, and maintenance activities?
      3. Hazard controls:
         1. Does the firm receive meat, poultry, shell eggs, or egg products, and if so, does the firm verify products against the accompanying shipping documents?
         2. Does the firm visually examine meat, poultry, shell eggs, and egg products before receiving them into inventory?
         3. Do the firm's receiving procedures limit, to the extent possible, the transfer time from the shipping conveyance to the cooler/freezer or other storage areas?
         4. Do the firm's shipping procedures limit, to the extent possible, the transfer time from the cooler or freezer, or other storage area to the shipping conveyance?
         5. Does the firm consider hazards that can occur during mail-order delivery to the consumer?
         6. Does the firm perform temperature monitoring (product or ambient), and if so, by what means (e.g., recording devices, monitoring records)?
         7. Are general production practices, as applicable, sufficient to preclude the adulteration of meat, poultry, shell eggs, and egg products?
         8. Does the firm thaw or temper frozen meat, poultry, and egg products, and if so, how does the firm monitor and document this process?
         9. Does the firm receive returned meat, poultry, shell eggs, and egg products?  If so, does the firm have appropriate controls to handle such product (e.g., identifying why the product was returned)?
         10. Does the firm receive non-amenable products and non-food items, and if so, does the firm verify products against the accompanying shipping documents and visually examine these products before receiving them into inventory?
         11. Does the firm maintain process control programs (e.g., Hazard Analysis and Critical Control Point (HACCP), Recall Plan, ISO 9000, or similar type programs)?
         12. If the firm maintains process control programs, is the firm following these programs?
   4. If there is an Attachment to this directive that covers the activity being conducted, Investigators are to incorporate that methodology into their surveillance activities.
      1. There are five Attachments included with this directive:
         1. Attachment 1, Definitions of Business Types;
         2. Attachment 2, In-Commerce Surveillance of Shell Eggs;
         3. Attachment 3, Shell Egg Handling Fact Sheet;
         4. Attachment 4, Instructions for Collecting Surveillance Samples of Raw Ground Beef at Retail; and
         5. Attachment 5, Fish FAQs and Activities - Siluriformes (Farmed and Wild-Caught).
      2. Investigators are to check the FSIS Website to see if there are updates to the attachments or if new attachments that address surveillance activities have been posted with this directive.
   5. If Investigators observe apparent violations of the Acts while conducting food safety activities, they are to follow the instructions in Chapter V of this directive.
4. FOOD DEFENSE
   1. When Investigators conduct in-commerce surveillance activities related to food defense, they are to verify that meat, poultry, shell eggs, and egg products are secure from threats and intentional acts of contamination.
   2. To accomplish food defense activities, Investigators are to follow the instructions in FSIS Directive 5420.3.
   3. If Investigators observe apparent violations of the Acts while conducting food defense activities, they are to follow the instructions in Chapter V of this directive.
5. NON-FOOD SAFETY CONSUMER PROTECTION
   1. When Investigators conduct in-commerce surveillance activities related to non-food safety consumer protection, they are to verify that meat, poultry, and egg products are not misbranded, economically adulterated, or otherwise unacceptable for reasons other than food safety. Additionally, Investigators are to verify that shell eggs are not unacceptable for reasons other than food safety.
   2. Investigators are to determine when, in some situations, misbranding may be a food safety concern or have a significant economic impact on consumers and industry.
   3. To accomplish non-food safety consumer protection verification activities, Investigators are, at a minimum, to:
      1. Examine meat, poultry, and egg products to determine whether they are misbranded according to the FMIA, PPIA, or EPIA.
      2. Review records associated with the products to determine whether those products are properly identified in accordance with the applicable statute.
      3. Verify nutritional labeling per FSIS Directive 7130.1, Verifying Nutrition Labeling for the Major Cuts of Single-Ingredient, Raw Meat and Poultry Products and Ground or Chopped Meat and Poultry Products.
      4. Verify records kept by retail firms that grind raw beef for sale in commerce maintain specific information about their grinding activities (9 CFR 320.1(b)(4); 80 FR 79231, Records To Be Kept by Official Establishments and Retail Stores That Grind Raw Beef Products).
   4. To determine whether meat, poultry, and egg products are properly marked, labeled, and packaged, and not misbranded, Investigators are to seek answers to questions including, but not limited to, the following:
      1. Do the products observed bear the mark of inspection, if required?
      2. Is the labeling false or misleading in any particular way?
      3. Are the products observed being offered for sale under the name of another food?
      4. Does the firm maintain records that identify the sources of the products observed?
   5. To determine whether shell eggs are properly marked, labeled, and packaged, Investigators are to evaluate whether consumer-packed shell egg containers are labeled with safe handling instructions (Attachment 2).
      
      NOTE: Under the EPIA, the term misbranding only applies to egg products.  Shell eggs that are not properly labeled are in violation of the labeling requirements but are not considered misbranded.
   6. To determine whether meat, poultry, shell eggs, and egg products are economically adulterated, Investigators are, at a minimum, to:
      1. Review business records, including invoices, labeling, and other information;
      2. Discuss with management or procurement officials any concerns or complaints they may have received relating to meat, poultry, shell eggs, and egg products and specific ingredients or components (e.g., fat, soy, or water) that if substituted, abstracted, or omitted, may cause products to be economically adulterated; and
      3. Collect samples for laboratory analysis as necessary.
   7. If Investigators observe apparent violations of the Acts while conducting non-food safety consumer protection activities, they are to follow the instructions in Chapter V of this directive.
6. IMPORTED PRODUCTS
   1. When Investigators conduct in-commerce surveillance activities related to imported products, they are to verify that imported products are wholesome, correctly marked and labeled, from eligible countries and certified foreign establishments, and not otherwise adulterated or misbranded.
   2. Imported meat, poultry, and egg products are considered "in commerce" when they receive FSIS reinspection and are marked with the official mark of inspection (9 CFR 327.1, Entry (entered)). If imported product bypasses FSIS reinspection, FSIS considers such product to be in commerce, a Failure-to-Present (FTP), and in violation of the Acts.  A FTP occurs when amenable products produced by a foreign establishment and properly certified by the foreign government are delivered into commerce, further processed in an official establishment, placed into storage, or otherwise distributed to the consumer without the benefit of FSIS import reinspection, as required. Investigators are to investigate all observed FTPs in accordance with FSIS Directive 8010.2 , Investigative Methodology.
   3. To accomplish imported product verification activities, Investigators are, at a minimum, to:
      1. Check the shipping container (if available) for the marks of Federal import re-inspection (i.e., "U.S. Inspected and Passed").
         
         NOTE: Shipping containers of product imported into the U.S. from Canada are not stamped "U.S. Inspected and Passed."
      2. Check the shipping container for a shipping mark (this is a sequence of alphanumeric characters also found on the inspection certificate and import application).
      3. Request, from the importer of record, product owner, custodian, or broker, documents relating to the importation of the product in question.  Such documents include, but are not limited to, FSIS Form 9540-1, Import Inspection Application and Report; an inspection certificate issued by the foreign government certifying that the product is eligible for importation into the U.S.; and any other shipping documents available.
      4. Use the shipping mark to verify the product's eligibility and import status using PHIS and information available on the FSIS Website. 
      5. Be aware of FTP shipments (FSIS Directive 9900.1, Imported Product Shipment Presentation).
      6. Be aware of meat, poultry, and egg products in commerce that are identified as "Refused Entry."  The Regional Director (RD) may notify an Investigator when there is potential that refused entry product was removed from the official import inspection establishment and distributed in commerce.  Investigators are to follow FSIS Directive 8010.2 for investigations.
      7. Refer to FSIS Directive 9010.1, United States Exported and Returned Products, for all products that may be U.S. Return.
   4. Investigators are to coordinate surveillance activities related to imported products with applicable FSIS program areas, the Animal and Plant Health Inspection Service, and other Federal, State, or local agencies, as appropriate.
   5. If Investigators identify meat, poultry, and egg products from a foreign country that have been illegally imported or smuggled into the United States; they are to follow the instructions in FSIS Directive 8010.2 .
      1. "Illegally imported products" are products that may be accurately labeled and properly manifested but do not meet all FSIS requirements for entry into the United States (e.g., beef carcasses from an ineligible country).
      2. "Smuggled products" are prohibited meat, poultry, or egg products that enter the United States by a covert or clandestine act or acts intended to conceal the prohibited products in order to avoid completely or circumvent the regulatory process of entry (e.g., chicken from an ineligible country packed into boxes labeled as containing fish).
   6. If Investigators observe apparent violations of the Acts while conducting surveillance activities related to imported products, they are to follow the instructions in Chapter V of this directive.
7. EXPORTED PRODUCTS
   1. While conducting in-commerce surveillance activities, Investigators may observe product for export.
   2. Investigators may examine product for export, if available, and review relevant export documentation.
   3. If Investigators observe apparent violations of the Acts while conducting surveillance activities related to exported products, they are to follow the instructions in Chapter V of this directive.
8. CUSTOM EXEMPT REVIEWS
   When Investigators conduct in-commerce surveillance activities related to meat and poultry products produced under the custom exemption or other similar exemptions (21 U.S.C. 464(c) and 623(a)), they are to follow FSIS Directive 8160.1, Custom Exempt Review Process.
9. ORDER VERIFICATION
   1. When Investigators conduct in-commerce surveillance activities related to order verification, they are to verify that persons or firms are in compliance with any criminal, civil, or administrative orders or other binding case disposition (e.g., administrative consent decision, civil consent decree, plea agreement, or pre-trial diversion agreement).
   2. Before conducting order verification activities, Investigators are to:
      1. Read and become familiar with the terms or conditions of any order or other binding case disposition;
      2. Review any previous activities including investigative, enforcement, or other activities or information associated with compliance with the terms of the order or other binding case disposition;
      3. Contact EOS to coordinate order verification activities, enforcement, or related matters and discuss any questions or concerns since EOS has Agency-wide responsibility for enforcement of criminal, civil, and administrative orders and other dispositions and is to provide guidance and coordinate verification activities among program areas;
      4. Contact, as necessary, the OFO District Manager or designee, if the order involves a Federal establishment, to discuss any questions or issues; and
      5. Contact, as necessary, the probation officer, if one is assigned in the case, to discuss any questions or issues.
   3. To accomplish order verification activities, Investigators are to:
      1. Meet with the subjects of the order and, as necessary, other individuals who may provide information relating to the subjects' compliance with the order.
      2. Discuss the terms of the order with firm management or officials.
      3. Verify, by direct observation, review of records, and other surveillance activities, the subject's compliance with the terms of the order.
      4. Conduct, as necessary, surveillance or other activities at consignees to verify compliance with the order.
   4. If Investigators find that any term or condition of an order has been violated, they are to:
      1. Identify, clearly explain, and discuss the findings, as appropriate, with the subjects of the order;
      2. Follow the instructions in Chapter V of this directive, as necessary, to address food safety or other violations;
      3. Notify EOS of the verification activity and findings and obtain guidance on additional verification, investigation, documentation, or other appropriate actions; and
      4. Document their findings in ANet, as well as any actions taken and the individuals contacted, such as EOS.
10. PUBLIC HEALTH RESPONSE
    1. Investigators may be called upon, at any time, to conduct or to assist other FSIS program areas or other Federal or State agencies in conducting public health response activities, which may include recall, consumer complaint, or foodborne illness outbreak investigations.
    2. When conducting activities related to recalls, Investigators are to follow the instructions in FSIS Directive 8080.1, Recall of Meat and Poultry Products.
    3. When conducting activities related to consumer complaints, Investigators are to follow the instructions in FSIS Directive 5610.1, Procedures to Implement the Consumer Complaint Monitoring System (CCMS).
    4. When conducting activities related to reports of foodborne illness potentially associated with meat, poultry, shell eggs, or egg products, Investigators are to follow the instructions in, FSIS Directive 8080.3, Foodborne Illness Investigations.
    5. If Investigators observe apparent violations of the Acts while conducting public health response activities, they are to follow the instructions in Chapter V of this directive.
11. EMERGENCY RESPONSE
    1. Investigators may be called upon, at any time, to conduct or to assist other FSIS program areas or other Federal, State, or Tribal agencies in conducting activities to prevent, prepare for, respond to, or recover from non-routine incidents resulting from intentional or non-intentional contamination affecting meat, poultry, shell eggs, and egg products (e.g., tampering, natural disaster, or terrorist attack).
    2. When conducting emergency response activities, Investigators are to follow the instructions in FSIS Directive 5500.2, Significant Incident Response.
    3. If Investigators observe apparent violations of the Acts while conducting emergency response activities, they are to follow the instructions in Chapter V of this directive.

CHAPTER IV - DOCUMENTATION

1. SELECTING THE APPROPRIATE SURVEILLANCE REASONS
   Investigators are to document the reason they are conducting the surveillance activity at the firm in ANet.
   1. Investigators are to use the definitions provided below to select the most appropriate reason for the surveillance activity.
      1. Allegation - Receipt of information alleging a violation involving FSIS regulated products and it does not meet the definition of a Consumer Complaint, Industry Complaint, or Referral by Government Agency.
      2. Consumer Complaint - A complaint received via the Consumer Complaint Monitoring System (CCMS) or directly from a consumer.
      3. Custom Exempt Review - Activities conducted to determine if firms producing custom exempt products are complying with the Acts and applicable regulations.
      4. Enforcement Follow-up - Activities conducted to monitor/verify compliance related to FSIS' issuance of a Notice of Warning (NOW), or order verification such as a Consent Decree, Consent Order, Plea Agreement, or Pre-Trial Diversion.
      5. Foodborne Illness - Activities conducted related to a foodborne illness.  Examples include, but are not limited to, trace-forward and trace-back activities.
      6. Industry Complaint - A complaint received from a business who handles FSIS regulated products.
      7. Investigation - Activities conducted related to an open investigation.
      8. Office of Inspector General (OIG) Hotline Complaint - Activities conducted in response to receipt of an OIG hotline complaint.
      9. Random - Surveillance activity that is unplanned.  Example is discovery of a new business that handles FSIS regulated products.
      10. Recall Effectiveness - Activities conducted to verify the effectiveness of a firm's voluntary recall of FSIS regulated product.
      11. Referral by Government Agency - Receipt of information or allegation involving FSIS regulated products from any Federal, State, or local agency.
      12. Retail Project - Use one of the choices in the drop-down list.
      13. Routine - Activities conducted as a routine surveillance based on tier (i.e., the firm is not subject to follow-up based on previous enforcement).
      14. Special Project - Use one of the choices in the drop-down list.
      15. Other - Use one of the choices in the drop-down list.
   2. For any retail project, special project or other activities, Investigators are to use the additional reasons listed below to properly attribute and account for those activities.  As noted, the Retail/Special/Other Project list allows for multi-selection, which can occur frequently, especially at a retail facility.<
      1. Ground Beef Sample Collected - Collecting an MT05/06 ground beef sample.
      2. Grinding Log Verification - Activities conducted to verify compliance with 9 CFR 320.1(b).
      3. Retail Deli Checklist or Tool Completed - Completing a retail deli checklist/tool in PHIS.
      4. Special Project - Defined by Headquarters (HQ), when necessary (e.g., National School Lunch Program Project).  This will bring up a separate text box that Investigators are to use to include the name of the project, as provided by HQ.
      5. Other - For use when no other reason is applicable.  Consult with supervisor before use.  This will bring up a separate text box that Investigators are to use to explain the reason for going to the firm.
2. SURVEILLANCE FINDINGS
   1. Upon completion of the surveillance activity, including follow-up surveillance, Investigators are to:
      1. Document their findings in ANet by completing all applicable fields in the Surveillance record.  When food defense activities are performed as a part of the surveillance, the Investigator is to document any findings in the Surveillance record to complete FSIS Form 5420-3, Food Defense Surveillance Findings;
      2. Identify, where appropriate, firms for follow-up surveillance activities; and
      3. Update, where needed, the Firm Information record for firms in ANet.  For a firm that is not in ANet, Investigators are to add the firm to ANet by creating a new Firm Information record and entering all required and known information.  Investigators are to attach, when needed, additional information (e.g., floor plan) in the File Attachments tab of the Firm Information record in ANet.
   2. When Investigators identify significant incidents during surveillance activities, they are to follow the instructions in FSIS Directive 5500.2 and complete FSIS Form 5500-4, Incident Report (IR).
   3. When Investigators identify product that has been illegally imported or smuggled, or is considered a FTP, they are to detain and control the product as set out in FSIS Directive 8410.1, Detention and Seizure, and initiate an investigation as set out in FSIS Directive 8010.2.
3. SURVEILLANCE NOTES
   1. When conducting surveillance activities in accordance with this directive, Investigators may document, at their discretion, their surveillance activities and findings in notes.
   2. If documented, Investigators are to be aware that notes may contain information related to open investigations, confidential commercial information, personal information, or other confidential information and are subject to the Freedom of Information Act, the Privacy Act, or other applicable legal requirements.
   3.  If surveillance activities result in the initiation of an investigation and notes of surveillance activities have
   4. been documented, Investigators are to maintain the notes with the investigative case file and follow FSIS Directive 8010.2 and FSIS Directive 8010.3 relevant to investigative notes.

CHAPTER V - APPARENT VIOLATIONS AND OTHER IRREGULARITIES

1. APPARENT VIOLATIONS
   1. When conducting surveillance activities, Investigators may observe apparent food safety or other violations of the Acts, Agency regulations, or applicable criminal, civil, or administrative orders or other orders or case dispositions.
   2. When Investigators observe apparent violations, they are to take one or more of the following actions as appropriate based on the relevant facts:
      1. Inform the management official, designee, owner, or product custodian of the apparent violation;
      2. Initiate an investigation, in accordance with FSIS Directive 8010.2 and collect evidence in accordance with FSIS Directive 8010.3;
      3. Initiate a product control action, in accordance with FSIS Directive 8410.1 ;
      4. Notify EOS, as per Chapter III, Section IX of this directive, of any violations of an order; and
      5. Notify the supervisor if, in the Investigators' judgment, additional personnel or resources are required to protect the health and welfare of consumers or the safety of Agency personnel.
2. OTHER IRREGULARITIES
   1. When conducting surveillance activities, Investigators may observe apparent violations or other irregularities involving non-amenable products or facility conditions that, although not subject to FSIS jurisdiction, are subject to the laws and regulations of other Federal, State, or local agencies.
   2. When Investigators observe apparent violations or other irregularities involving non-amenable products or facilities subject to other authorities, they are, as appropriate, to:
      1. Inform the management official, designee, owner, or the product custodian of the apparent violation or other irregularity;
      2. Contact, immediately if necessary, the appropriate Federal, State, or local agency to inform that office of the apparent violation or other irregularity observed;
      3. Provide support, as necessary, to the agency or office contacted to protect the health and welfare of consumers; and
      4. Document, in the ANet Surveillance record, the apparent violation or other irregularity observed and the contact and referral made to the appropriate Federal, State, or local agency.
3. QUESTIONS
   Refer questions regarding this directive through supervisory channels.