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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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SUBCHAPTER 5.4 - FOOD

SUBCHAPTER 5.4 - FOOD
5.4.1 - FOOD INSPECTIONS
5.4.1.1 - Preparation and References
5.4.1.2 - Inspectional Authority
5.4.1.2.1 - WRITTEN DEMAND FOR RECORDS
5.4.1.2.2 - WRITTEN REQUEST FOR INFORMATION
5.4.1.3 - Records Access Under Sections 414 and 704 of the FD&C ActHighlighted to denote updated text
5.4.1.4 - Food and Cosmetic Defense Inspectional Activities
5.4.1.4.1 - FOOD AND COSMETIC SECURITY
5.4.1.4.2 - RECONCILIATION EXAMINATIONS
5.4.1.4.3 - RECONCILIATION EXAMINATION GUIDANCE PART A
5.4.1.4.4 - RECONCILIATION EXAMINATION GUIDANCE PART B
5.4.1.4.5 - SPECIAL SAFETY PRECAUTIONS
5.4.1.5 - Food Registration
5.4.1.5.1 - FACILITIES EXEMPTED FROM REGISTRATION
5.4.1.5.2 - AGENCY WEBSITE LINK
5.4.1.5.3 - INSPECTIONAL GUIDANCE
5.4.1.6 - CFSAN Bio-research Monitoring
5.4.2 - PERSONNEL
5.4.2.1 - Management
5.4.2.2 - Employees
5.4.3 - PLANTS AND GROUNDS
5.4.3.1 - Plant Construction, Design and Maintenance
5.4.3.2 - Waste Disposal
5.4.3.3 - Plant Services
5.4.4 - RAW MATERIALS
5.4.4.1 - Handling Procedure
5.4.4.2 - Condition
5.4.4.3 - Food Chemicals Codex
5.4.5 - EQUIPMENT AND UTENSILS
5.4.5.1 - Filtering Systems
5.4.5.2 - Sanitation of Machinery
5.4.5.3 - Conveyor Belt Conditions
5.4.5.4 - Utensils
5.4.5.5 - Mercury and Glass Contamination
5.4.5.6 - UV Lamps 
5.4.5.7 - Chlorine Solution Pipes
5.4.5.8 - Sanitation Practices
5.4.6 - MANUFACTURING PROCESS
5.4.6.1 - Ingredient Handling
5.4.6.2 - Formulas
5.4.6.3 - Food Additives
5.4.6.4 - Color Additives
5.4.6.5 - Quality Control
5.4.6.5.1 - INSPECTION SYSTEM
5.4.6.5.2 - LABORATORY TESTS
5.4.6.5.3 - MANUFACTURING CODE SYSTEM
5.4.6.6 - Packaging and Labeling
5.4.6.6.1 - QUANTITY OF CONTENTS
5.4.6.6.2 - LABELING
5.4.6.6.3 - NUTRITIONAL AND ALLERGEN LABELING
5.4.7 - SANITATION
5.4.7.1 - Routes of Contamination
5.4.7.1.1 - INSECTS
5.4.7.1.2 - RODENTS
5.4.7.1.3 - PESTICIDES
5.4.7.1.4 - OTHER
5.4.7.2 - Microbiological Concerns
5.4.7.2.1 - PROCESSING EQUIPMENT
5.4.7.2.2 - EMPLOYEE PRACTICES
5.4.7.3 - Storage
5.4.7.3.1 - FOOD TRANSPORT VEHICLES
5.4.7.3.2 - VEHICLES AT RECEIVERS
5.4.7.3.3 - VEHICLES AT SHIPPERS
5.4.8 - DISTRIBUTION
5.4.8.1 - Promotion and Advertising
5.4.8.2 - Recall Procedure
5.4.8.3 - Complaint Files
5.4.9 - OTHER GOVERNMENT INSPECTION
5.4.9.1 - Federal
5.4.9.2 - State and Local
5.4.9.3 - Grade A Dairy Plant Inspections
5.4.10 - FOOD STANDARDS
5.4.10.1 - Food Establishment Inspection
5.4.10.2 - Food Inspection Report
5.4.10.2.1 - ESTABLISHMENT INSPECTION RECORD (EI RECORD)
5.4.10.2.2 - BODY OF REPORT
5.4.10.2.3 - SPECIAL INFORMATION SECTION
5.4.10.3 - Violative Inspections
5.4.11 - RE-INSPECTION CONDUCTED UNDER SECTION 743 OF THE FD&C ACT
5.4.11.1 - Conducting Inspections for which Fees can be Assessed
5.4.11.1.1 - REGULATED INDUSTRY NOTIFICATION
5.4.11.1.2 - RE-INSPECTION ASSIGNMENT GENERATOR
5.4.11.1.3 - RE-INSPECTION REPORTING
5.4.12 - PESTICIDES
5.4.12.1 - Pesticide Inspections
5.4.12.2 - Current Practices
5.4.12.3 - Growers
5.4.12.3.1 - PESTICIDE APPLICATION
5.4.12.3.2 - PESTICIDE MISUSE/DRIFT/SOIL CONTAMINATION
5.4.12.4 - Packers and Shippers
5.4.12.5 - Pesticide Suppliers
5.4.12.6 - Pesticide Applicators
5.4.12.7 - Sample Collections 

SUBCHAPTER 5.4 - FOOD

 5.4.1 - FOOD INSPECTIONS

Food plant inspections are conducted to evaluate the methods, facilities, and controls used in manufacturing, storage and distribution of foods.

See CFSAN Office of Compliance's intranet website for the most current guidance (e.g., compliance programs, field assignments, field guidance).

 5.4.1.1 - Preparation and References

Before undertaking an inspection:

1.    Review the district files of the firm to be inspected and acquaint yourself with the firm's history, related firms, trade marks, practices and products. The review will identify products difficult to manufacture, require special handling, special processes or techniques, and hours of operation, which is especially important in bacteriological inspections. Remove, for subsequent investigations and discussion with management, Complaint/Injury Reports, which are marked for follow-up during the next inspection. See IOM 5.2.8.

2.    Become familiar with current programs relating to the particular food or industry involved and relevant DFFPOIHighlighted to denote updated text inspection guides. Become familiar with any applicable Compliance Policy Guide (CPG Chap 5).

3.    Understand the nature of the assignment and whether it entails certain problems, e.g., Salmonella or other bacteriological aspects.

4.    Review the FD&C Act Chapter IV - Food.

5.    Review and become familiar with the appropriate parts of 21 CFR pertaining to foods, for example :

a.    21 CFR Part 110 - GMP's on foods

b.    21 CFR Parts 108 and 113 - Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers

c.    21 CFR Part 114 - Acidified Foods

d.    21 CFR Part 120 - HACCP Systems (covers Juice Processors)

e.    21 CFR Part 123 - Fish and Fishery Products

f.     21 CFR Part 129 - Processing and Bottling of Bottled Drinking Water

g.    21 CFR Part 130, et al - Food Standards

h.    21 CFR Part 1240 - Control of Communicable Disease

i.      21 CFR Part 1250 - Interstate Conveyance Sanitation

6.    Review reference materials on food technology and other subjects available in the District Inspectional Reference Library.

7.    If you are assigned to inspect food-service establishments under the FDA - Secret Service Agreement, you should use the most current copy of the "Food Code" and be standardized in its use. All Regional Food Service Specialists and most Interstate Travel Sanitation Specialists are standardized in use of the code.

8.    Be familiar with the "Food Chemicals Codex". See IOM 5.4.4.3.

 5.4.1.2 - Inspectional Authority

See IOM subchapter 2.2 for broader information on this topic.

Authority to Obtain Records and Information in LACF and Acidified Foods Plants:

FDA's regulation in 21 CFR 113 requires commercial processors of low-acid foods packaged in hermetically sealed containers to maintain complete records of processing, production and initial distribution. 21 CFR 114 requires the same of commercial processors of acidified foods. 21 CFR 108.25(g) and 21 CFR 108.35(h) provide that a commercial processor shall permit the inspection and copying of the records required by 21 CFR 113 and 21 CFR 114 by duly authorized employees of FDA. The demand for these records must be in writing on an FDA 482a, Demand for Records, signed by you and must identify the records demanded.

 5.4.1.2.1 - WRITTEN DEMAND FOR RECORDS

To obtain the records:

  1. Prepare a FDA 482a, "Demand for Records", listing the records demanded. Describe the processing records to be reviewed and/or copied as accurately as you can, e.g., "All thermal process and production records mandated by 21 CFR 113 (or 114 if applicable) for the foods (state name of food) processed at this plant on (specific date or period of time)". If only a specific record is desired list it specifically as follows: e.g., "Fill Weight Records for #2 Filling Machine for the period 4-15-87 through 6-7-87."
  2. Sign the form.
  3. Issue the original to the same person to whom the FDA 482, "Notice of Inspection", was issued.
  4. Submit the carbon copy with your EIR.

 5.4.1.2.2 - WRITTEN REQUEST FOR INFORMATION

21 CFR 108.35(c)(3)(ii) states commercial processors engaged in thermal processing of low-acid foods packaged in hermetically sealed containers shall provide FDA with any information concerning processes and procedures necessary by FDA to determine the adequacy of the process. 21 CFR 108.25(c)(3)(ii) requires the same of commercial processors of acidified foods. The information in this regulation is the data on which the processes are based. Many processors will not have this information and in fact 21 CFR 113.83 requires only that the person or organization establishing the process permanently retain all records covering all aspects of establishing the process. The processor should, however, have in his files a letter or other written documentation from a processing authority delineating the recommended scheduled process and associated critical factors.

You may encounter situations where you believe control of certain factors is critical to the process and there is no evidence to document these factors were considered when the process was established (e.g., a change in formulation which could affect consistency). It is appropriate to issue a written request for a letter or other written documentation from a processing authority, which delineates the recommended scheduled process and associated critical factors. This represents the processing authority's conclusions and should correlate with the filed process.

If you believe control of certain factors are critical to the process and are not delineated in the process authority's recommendation or the filed process, obtain all available information about the situation. Include the name of the person or organization who established the process and the specific practices of the firm. This information should be included in your report and forwarded by your District to the Center for Food Safety and Applied Nutrition, Division of Enforcement (HFS-605) for review, as soon as possible. If the process establishment data and information is deemed necessary by the center, they will either request it directly from the processor or will direct the district to request it. If requested to obtain the information:

  1. Prepare a FDA 482b - Request for Information listing the specific information requested. Specify each product involved by food product name and form, container size and processing method.
  2. Sign the form.
  3. Issue the original to the same person to whom the FDA 482, "Notice of Inspection", was issued.
  4. Submit the carbon copy with your EIR.

  5.4.1.3 - Records Access Under Sections 414 and 704 of the FD&C Act Highlighted to denote updated text

The Food Safety Modernization Act amended Section 414 of the Act to provide FDA with access and the ability to copy records under the following circumstances:

  1. FDA has a reasonable belief that an article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner:Highlighted to denote updated text
    1. Is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, andHighlighted to denote updated text
    2. The records are needed to assist FDA in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.ghlighted to denote updated textHighlighted to denote updated text
  2. FDA believes that there is a reasonable probability that use of or exposure to an article of food, and any other article of food that the FDA reasonably believes is likely to be affected in a similar manner:Highlighted to denote updated text
    1. Will cause serious adverse health consequences or death to humans or animals, andHighlighted to denote updated text
    2. The records are needed to assist FDA in determining whether there is a reasonable probability that the use of exposure to the food will cause serious adverse health consequences or death to human or animals.Highlighted to denote updated text
       

If, during an inspection, you believe the above conditions exist, and:Highlighted to denote updated textHighlighted to denote updated text

  1. The firm refuses to provide access to the records, orHighlighted to denote updated text
  2. Based on past experience, the District anticipates that the firm may refuse to provide access to records, or Highlighted to denote updated text
  3. The firm requests FDA to provide a separate written request for records,Highlighted to denote updated text

Notify your supervisor and consult with your district Compliance Branch.Highlighted to denote updated text

District management will obtain OE concurrence before you issue the Form FDA 482c Notice of Inspection - Request for Records (Exhibit 5-10. District management will notify FDA's Office of Emergency Operations (OEO) of any situation requiring issuance of Form FDA 482c.  (OEO contact number: 1-866-300-4374 or 301-796-8240 - 24 hours/day.)  OEO will notify CFSAN or CVM, as appropriate, OO/OFFO, OE and OCC according to standard operating procedures to obtain a determination that the situation warrants issuance of Form FDA 482c.  OE, in consultation with CFSAN or CVM OEO, OO/OFFO and the District, will determine if the standards for records inspection in paragraphs (1) or (2) of section 414(a) have been met and identify the scope of the records to request.  Issue an FDA 482c Notice of Inspection – Request for Records. See exhibit 5-10 according to their instructions.Highlighted to denote updated text

FDA may at a later time, request additional records related to the same article of food, or other article of food that is likely to be affected in a similar manner, as long as the criteria in 414(a)(1) or (a)(2) continue to be met. The request for additional records may be verbal or written as necessary to facilitate access to the records.Highlighted to denote updated text

Investigators should document in the EIR a firm’s refusal to allow access to records or a firm’s request for a written request for records and issuance of Form FDA 482c.Highlighted to denote updated text

 5.4.1.4 - Food and Cosmetic Defense Inspectional Activities

Food and cosmetics security inspectional activities should be conducted during all routine food and cosmetics safety inspections. During the normal course of the inspection be alert to opportunities for improvement or enhancement of the firm’s food and cosmetics security preventive measures, as compared to those recommended in the guidance documents described below. You should not perform a comprehensive food and cosmetics security audit of the firm or conduct an extensive interview of management or employees in an attempt to determine the level of adoption of preventive measures listed in the guidance. The goal is to facilitate an exchange of information to heighten awareness on the subject of food and cosmetics security.

 5.4.1.4.1 - FOOD AND COSMETIC SECURITY

Inspectional activities relative to food and cosmetic security for routine food and cosmetic establishment inspections should include:

  1. Discussion with firm management of relevant FDA guidance documents including:
    1. Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance
    2. Importers and Filers: Food Security Preventive Measures Guidance
    3. Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance
    4. Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance
    5. Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations, and Fluid Milk Processors: Food Security Preventive Measures Guidance.

    These documents should be used as references during inspections, as appropriate. Copies may be obtained at: http://www.fda.gov/Food/FoodDefense/FoodSecurity/default.htm. If firm management does not already have a copy of the relevant guidance documents provide them with hard copies or information on how to obtain the guidance from FDA’s web site.

  2. Identification of opportunities for improvement or enhancement of the firm’s food and cosmetic security preventive measures, as compared to those recommended in the guidance documents, and encouragement of management to make such improvements or enhancements to their security system.

Keep in mind that: the guidance does not represent mandatory conditions or practices; some of the recommended food and cosmetics security preventive measures may not be appropriate or practical to the specific operation; and other means of achieving the goals of the preventive measures listed in the guidance may be more suitable for the specific operation than those cited as examples. The important message for management is to consider the goals of the food and cosmetics security preventive measures; evaluate the goals relative to the specifics of their operation; and address those that are relevant to the extent practical.

Food and cosmetics security observations should not be listed on form FDA-483, Inspectional Observations, unless they likewise constitute deviations from Current Good Manufacturing Practice. Security discussions should be handled discretely and should only involve management of the firm.

The fact that the discussion took place and, if applicable, that a copy of the guidance document(s) was provided should be recorded in the Summary section of the EIR. For example, under a section heading titled “Food and Cosmetics Security” you should only state, “A copy of the Food and Cosmetics Security Guidance documents were provided to and food and cosmetics security issues were discussed with (name of firm official).” The details of inspectional findings regarding security should NOT be recorded. You should also minimize the quantity and detail of notes taken relative to the firm’s food and cosmetics security program, taking only those needed to serve as a “memory jog” during the discussion with management.

 5.4.1.4.2 - RECONCILIATION EXAMINATIONS

During routine food and cosmetic inspections, conduct one reconciliation examination during each food and cosmetic establishment inspection. The examinations are to be conducted on raw materials used in the manufacture of foods or cosmetics, or finished products received by the firm for further distribution. Preference should be given to products of foreign origin. Where possible, these examinations should be performed on products as they are received by the firm.

Consult the factory jacket for any information on special conditions in the facility that may affect selection of personal protective equipment; consult your supervisor for any recommendations on personal protective equipment; and have available all necessary personal protective equipment to conduct the activity.

As Part of an Import Field Examination and Entry Review - See IOM 6.3.1 and 6.4.3. For imported food and cosmetics, a reconciliation examination should be conducted:

  1. Per Part A [IOM 5.4.1.4.3] during all routine import field exams. You should only report time under the Counter Terrorism PAC at the direction of your supervisor or if there is a for cause assignment.
  1. In instances where review of entry information raises suspicion (resulting in a detailed reconciliation exam per Part B [IOM 5.4.1.4.4]).
    A detailed reconciliation exam should be conducted when there are anomalies in entry declaration information. These may include new, unusual, or unfamiliar commodities, manufacturers, importers; suspicious trans-shipments; or credibility issues such as those between the product and declared country of origin.
    If anomalies are found, entry documents should be requested and reviewed for discrepancies between the information declared through electronic filer submissions and that found in entry documents. Entry documents may include invoices, bills of lading, export certifications, and other relevant documents obtained from the importer, filer, or manufacturer/processor of the product. Fields in which discrepancies are found that may raise concern include country of origin, manufacturer, product description, product code, and quantity.
    Avoid duplication of examination of the same foreign manufacturer, unless a prior reconciliation examination disclosed an unexplained discrepancy.

Follow guidance in IOM 5.4.1.4.3 to IOM 5.4.1.4.4 below for domestic and import reconciliation exams.

 5.4.1.4.3 - RECONCILIATION EXAMINATION GUIDANCE PART A

Reconciliation examinations are performed to ensure that:

  1. The food or cosmetic is what it purports to be
  1. There are not unexplained differences in the quantity of product ordered, shipped, and received, and
  1. There are no signs of tampering or counterfeiting.

Before initiating the exam make a general assessment of the appearance of the lot. Look for packaging that: appears to have been opened and resealed; appears wet, stained, punctured, or powdered. Also be alert to abnormal chemical odors. If any of these conditions are detected stop the exam and contact your supervisor for guidance. If the lot appears normal proceed with the examination. To the extent possible the exam should be performed in a well-ventilated, well-lit area.

Determine, to the extent possible, whether:

  1. The actual goods in a lot are the same as those that are declared in the shipping documents
  2. There is consistency in the manufacturer declared on the product labeling, bulk product packaging, and shipping documents; and
  3. There is no (unexplainable) inconsistency in actual quantity of goods in the lot, and the quantity ordered and declared in the shipping documents.

If no unexplained inconsistencies are detected, no further action is indicated.

If unexplainable inconsistencies are detected, document the occurrence, including photographs of the labeling and packaging, and an accurate count of the lot. Contact your supervisor, who should, in the case of imported products, contact the U.S. Customs and Border Protection for appropriate action. If the examination discloses evidence that inaccurate product identification data was submitted to the OASIS entry screening system, the District should evaluate the need for follow-up with a compliance filer evaluation and consider providing the information to the U.S. Customs and Border Protection for appropriate action. 

In addition, if unexplained inconsistencies are detected, follow part B [IOM 5.4.1.4.4] of this guidance while conducting a detailed reconciliation exam.

 5.4.1.4.4 - RECONCILIATION EXAMINATION GUIDANCE PART B

Open the shipping packaging of a quantity of product approximating the square root of the number of shipping cartons/packages in the lot, and examine the contents. Look for the following:

  1. Product identity on the package that does not match the identity declared on the shipping documents
  2. Mixed product sizes within a carton or within the lot;
  3. Product sizes that do not match the sizes declared on the shipping documents
  4. Differences in product configuration or package type (e.g. plastic containers mixed with glass jars or aluminum or steel cans)
  5. Easily apparent variations in weight
  6. Product labels that display crude, unprofessional, or inconsistent styles of print, color or use of language
  7. Unusual placement of labels (e.g. off-center)
  8. Variations in lot coding ink color, appearance of embossing, or format (e.g., two line vs. three line, use of letters, numbers and symbols). unusually excessive use of a single code in a very large lot
  9. Differences between the actual can codes in the lot and those listed on the shipping documents
  10. The existence of a tamper-evident notice on the labeling when the packaging does not contain a tamper-evident feature
  11. Product that is beyond its expiration date
  12. Inconsistencies in expiration dates within a lot

If no unexplainable discrepancies are noted select at least 1 package at random from the entire shipment and examine their contents. For those products that the contents are visible through the package it is not necessary to open the package. For other products, open the package and examine and field destroy the contents. Look for the following:

  1. Differences between the product and that which is declared on the label
  2. Color differences in the product between containers of the same lot
  3. Style differences in the product between containers of the same lot or between the actual product and the label and document declaration (e.g., sliced vs. whole, colorless noodles vs. egg noodles)
  4. Readily detectable abnormal odors (e.g. strong decomposition, bitter almond, petroleum odor, garlic, chlorine, sulfur). Note: specific sensory examination is not expected.

Verification that the product is consistent with the product ordered may require that you obtain information from the owner of the goods, importer, filer, or custom house broker. Review of the following types of documentation may be necessary to accomplish the above instructions, to the extent that they are available: authentic label supplied by the owner of the goods, importer, filer, or custom house broker; purchase order; invoice; shipping records (bill of lading, weigh bill, manifest). Depending on the findings of the exam and record review, you may wish to request that the importer assist in an evaluation of the authenticity of the product, based on the importer’s experience with the product.

Every effort should be made to document any discrepancies through use of photographs, and additional records that may be available from the filer, importer, owner, or customs house broker.

 5.4.1.4.5 - SPECIAL SAFETY PRECAUTIONS

See IOM Subchapters 1.5 Safety, subsections including 1.5.1.1 thru 1.5.1.4, and Section 1.5.3 on sampling hazards.

When performing an establishment inspection or reconciliation examination, follow these instructions:

  1. If there are no signs of tampering or counterfeiting, use level I protection, which consists of: work gloves; coveralls; work boots; and in a dusty situation, a dust mask.
  2. If there are signs of tampering or counterfeiting, use level II protection and consult your supervisor for any additional safety precautions needed. Level II protection consists of: work gloves worn over surgical gloves; full face respirator with appropriate cartridges; disposable coveralls; and work boots.

 5.4.1.5 - Food Registration

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires most domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with FDA by December 12, 2003. The Bioterrorism Act covers both interstate and intrastate firms. FDA published a final rule on October 3, 2005 (70 FR 57505) to implement this requirement. The regulations are codified at 21 CFR 1 Subpart H - Registration of Food Facilities. The agency has also issued a guidance to industry document, "Questions and Answers Regarding Registration of Food Facilities." Facilities may register electronically at http://www.access.fda.gov, by mail or fax, or by CD-ROM for multiple submissions. Registrations will be maintained in the FDA Unified Registration and Listing System (FURLS). Facilities are not considered to be registered until their information is entered into FURLS.

The owner, operator, or agent in charge of a facility must register the name and address of each facility at which, and all trade names under which, the registrant conducts business. If applicable, they must register the same information for their parent companies. Foreign facilities must also provide information about their U.S. Agent.

The purpose of registration is to provide sufficient and reliable information about food facilities. When used with the detention, recordkeeping, and prior notice provisions of the Bioterrorism Act, registration will help to provide information on the origin and distribution of food and feed products to allow for detection and quick reaction to real and potential threats to these products. In the event of a potential threat or an outbreak of foodborne illness, such information will help FDA and other authorities to notify food facility representatives and investigate the event, source, and/or cause of the outbreak. Also, it will enable FDA to notify quickly the facilities that might be affected by the outbreak.

For both domestic and foreign facilities, the Bioterrorism Act makes failure to register a prohibited act. In addition, food from an unregistered foreign facility may be held at the port of entry. Failure to register under the BT Act, does not make the food product(s) violative.

FDA estimates that the total number of food facilities that must register could exceed 400,000, including both domestic and foreign facilities.

 5.4.1.5.1 - FACILITIES EXEMPTED FROM REGISTRATION

The Bioterrorism Act, as implemented by the interim final rule for registration of food facilities exempts the following from registration:

  1. A foreign facility, if food from such facility undergoes further manufacturing/processing (including packaging) by another facility outside the U.S. (Note: A facility is not exempt under this provision if the further manufacturing/processing (including packaging) conducted by the subsequent facility consists of adding labeling or any similar activity of a de minimis nature. The facility conducting the de minimis activity also must register;
  2. Farms that are devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves of, and cooling produce are considered part of harvesting. The term “farm” includes:
    1. Facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership; and
    2. Facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.
  3. Retail food establishments whose sales to consumers exceed their sales to non-consumers (businesses are considered non-consumers);
  4. Restaurants that prepare and serve food directly to consumers for immediate consumption;
  5. Nonprofit food establishments in which food is prepared for, or served directly to, the consumer;
  6. Fishing vessels, including those that not only harvest and transport fish but also engage in practices such as heading, eviscerating, or freezing intended solely to prepare fish for holding on board a harvest vessel. However, those fishing vessels that otherwise engage in processing fish are required to register. For the purposes of this section, "processing" means handling, storing, preparing, shucking, changing into different market forms, manufacturing, preserving, packing, labeling, dockside unloading, holding, or heading, eviscerating, or freezing other than solely to prepare fish for holding on board a harvest vessel;
  7. Facilities that are regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.)

Other exemptions from registration in the interim final rule are based on the definition of food included within the scope of the registration regulation. Facilities that manufacture/process, pack, or hold food contact substances (including packaging materials) or pesticides are exempt from registration.

 5.4.1.5.2 - AGENCY WEBSITE LINK

More specific information regarding the Bioterrorism Act and food registration may be obtained at the following website: http://www.fda.gov/Food/default.htm.

 5.4.1.5.3 - INSPECTIONAL GUIDANCE

See Compliance Policy Guide Sec. 110.300: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. During inspections of domestic and foreign facilities subject to the rule, make sure that firm management is aware of the registration requirements. Inform the firm's management that information regarding food security, the BT Act, facility registration, required and optional information, definitions, exemptions, and penalties for failure to register, etc., is available at the following website: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/default.htm. For facilities that are required to register, but have not yet done so, encourage electronic registration (see http://www.fda.gov/oc/bioterrorism/bioact.html), and refer them to a copy of the blank registration form (see http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM071977.pdf) and the web site address (http://www.access.fda.gov) for electronic registration. Also encourage submission of the optional information on the form to assist and facilitate future communication with the facility as intended by the BT Act.

Document the registration status of the firm, and registration discussions with firm management, in the “Summary of Findings and Discussion with Management” sections of the EIR. Per CPG 110.300, do not report the FURLS Registration number. Observations about failure to register are NOT to be placed on the FDA 483.

 5.4.1.6 - CFSAN Bio-research Monitoring

Bio-research monitoring (BIMO) assignments for foods will generally be issued by the Center for Food Safety and Applied Nutrition (CFSAN) (see IOM 5.5.6).

 5.4.2 - PERSONNEL

 5.4.2.1 - Management

Follow the guidance described in IOM 5.3.6 when documenting individual responsibility including obtaining the full name and titles of the following individuals:

  1. Owners, partners, or officers.
  2. Other management officials or individuals supplying information.
  3. Individuals to whom credentials were shown and FDA 482, Notice of Inspection, and other inspectional forms issued.
  4. Individuals refusing to supply information or permit inspection.
  5. Individuals with whom inspectional findings were discussed or recommendations made.

Regulations require plant management take all reasonable measures and precautions to assure control of communicable disease, employee cleanliness, appropriate training of key personnel, and compliance by all personnel with all requirements of 21 CFR 110.10, 113.10, and 114.10.

Determine if adequate supervision is provided for critical operations where violations are likely to occur if tasks are improperly performed.

 5.4.2.2 - Employees

Improper employee habits may contribute to violative practices in an otherwise satisfactory plant. Observe the attitude and actions of employees during all phases of the inspection. Observe employees at their work stations and determine their duties or work functions. Note whether employees are neatly and cleanly dressed and whether they wear head coverings which properly cover their hair.

Determine if employees working with the product have obvious colds, or infected sores, cuts, etc. Under no circumstance should you swab a sore, touch or remove a bandage from an employee in an attempt to obtain bacteriological data. To do so is a violation of personal privacy, possibly hazardous to you and/or the employee, and usually provides little useful data.

Note whether employees eat while on duty.

Observe and record insanitary employee practices or actions showing employees handling or touching unsanitized or dirty surfaces and then contacting food products or direct food contact surfaces. Such practices might include employees spitting, handling garbage, placing their hands in or near their mouths, cleaning drains, handling dirty containers, etc. and then handling food product without washing and sanitizing their hands. Observe whether employees comply with plant rules such as, "No smoking", "Keep doors closed", "Wash hands before returning to work", etc. See IOM 5.4.7.2.2.

Be alert to employees handling insanitary objects, then quickly dipping their hands in sanitizing solutions without first washing them. Depending upon the amount and type of filth deposited on the hands during the handling of insanitary objects, such attempts at sanitizing are questionable at best. Sanitizers work most effectively on hands, which have been first cleaned by washing with soap and water.

Conversations with employees doing the work may provide information on both current and past objectionable practices, conditions and circumstances. These should be recorded in your notes.

Where appropriate, determine employee education and training. Also determine type, duration, and adequacy of firm's training programs, if any, to prepare employees for their positions and to maintain their skills. See IOM 5.10.4.1.

 5.4.3 - PLANTS AND GROUNDS

Observe the general nature of the neighborhood in which the firm is located. Environmental factors such as proximity to swamps, rivers, wharves, city dumps, etc., may contribute to rodent, bird, insect or other sanitation problems.

 5.4.3.1 - Plant Construction, Design and Maintenance

Determine the approximate size and type of building housing the firm and if suitable in size, construction, and design to facilitate maintenance and sanitary operations. Check placement of equipment, storage of materials, lighting, ventilation, and placement of partitions and screening to eliminate product contamination by bacteria, birds, vermin, etc. Determine any construction defects or other conditions such as broken windows, cracked floor boards, sagging doors, etc. which may permit animal entry or harborage.

Inspect toilet facilities for cleanliness, adequate supplies of toilet paper, soap, towels, hot and cold water, and hand washing signs. Check if hand washing facilities are hidden, or if located where supervisory personnel can police hand washing.

Determine who is responsible for buildings and grounds maintenance. Many facilities such as docks, wharves, or other premises are owned and maintained by other firms, municipalities, or individuals for lease for manufacturing operations. Determine who is legally responsible for repairs, maintenance, rodent proofing, screening, etc. Evaluate the firm's attitude toward maintenance and cleaning operations.

 5.4.3.2 - Waste Disposal

Waste and garbage disposal poses a problem in all food plants depending upon plant location and municipal facilities available.

Check the effectiveness of waste disposal on the premises and ensure it does not cause violative conditions or contribute toward contamination of the finished products. Check for in-plant contamination of equipment and/or product, if its water is supplied from nearby streams, springs, lakes or wells.

Suspected dumping of sewage effluent into nearby streams, lakes, or bay waters near water intakes can be documented by color photographs and water soluble fluorescein sodium dye. Place approximately two ounces dye, which yields a yellowish red color, into the firm's waste system and/or toilets, as applicable, and flush the system. The discharge area of the effluent becomes readily visible by a yellowish-red color on the surface of the water as the dye reaches it. Color photographs should be taken.

Determine collecting or flushing methods used to remove waste from operating areas. If water is used, determine if it is recirculated and thus may contaminate equipment or materials.

Determine the disposition of waste materials that should not be used as human food such as rancid nuts, juice from decomposed tomatoes, etc.

Determine the disposition of waste, garbage, etc., which contain pesticide residues. Determine how this is segregated from waste material which contains no residues and which may be used for animal feed.

 5.4.3.3 - Plant Services

If applicable, check steam generators for capacity and demand. Demand may reach or exceed the rated capacity, which could effect adequacy of the process. Check boiler water additives if steam comes in direct contact with foods.

Check central compressed air supply for effective removal of moisture (condensate) and oil. Determine if any undrained loops in the supply line exist where condensate can accumulate and become contaminated with foreign material or microorganisms.

 5.4.4 - RAW MATERIALS

List in a general way the nature of raw materials on hand. Itemize and describe those, which are unusual to you, or involved in a suspected violation (copy quantity of contents and ingredient statements, codes, name of manufacturer or distributor, etc.). Be alert for additives and preservatives. Evaluate the storage of materials. Determine the general storage pattern, stock rotation and general housekeeping. Materials should be stored so they are accessible for inspection. Thoroughly check ceilings, walls, ledges, and floors in raw material storage areas for evidence or rodent or insect infestation, water dripping or other adverse conditions.

 5.4.4.1 - Handling Procedure

Determine if growing conditions relative to disease, insects, and weather are affecting the raw material. Check measures taken for protection against insect or rodent damage. Raw materials may be susceptible to decomposition, bruising or damage, e.g., soft vegetables and fruits delivered in truckload lots. Determine the holding times of materials subject to progressive decomposition.

 5.4.4.2 - Condition

Evaluate the firm's acceptance examination and inspection practices including washing and disposition of rejected lots. Where indicated, examine rejected lots and collect appropriate samples and report consignees.

Determine the general acceptability of raw materials for their intended use and their effect on the finished product. Raw stocks of fruits or vegetables may contribute decomposed or filthy material to the finished product. Be alert for use of low quality or salvage raw materials. Check bags, bales, cases and other types of raw material containers to determine signs of abnormal conditions, indicating presence of filthy, putrid or decomposed items. Check any indication of gnawed or otherwise damaged containers, to ascertain if material is violative. Be alert to contamination of raw materials by infested or contaminated railroad cars or other carriers.

Document by photographs, exhibits or sketches any instances where insanitary storage or handling conditions exist.

 5.4.4.3 - Food Chemicals Codex

Any substance used in foods must be food-grade quality. FDA regards the applicable specifications in the current edition of the publication "Food Chemicals Codex" as establishing food-grade unless FDA publishes other specifications in the Federal Register.

Determine whether firm is aware of this publication and whether or not they comply.

 5.4.5 - EQUIPMENT AND UTENSILS

By arriving before processing begins, you are able to evaluate conditions and practices not otherwise observable before plant start-up. This includes adequacy of clean-up, where and how equipment is stored while not in use, how hand sanitizing solutions and food batches are prepared and if personnel sanitize their hands and equipment before beginning work.

Dirty or improperly cleaned equipment and utensils may be the focal point for filth or bacterial contamination of the finished product. Examine all equipment for suitability and accessibility for cleaning. Determine if equipment is constructed or covered to protect contents from dust and environmental contamination. Open inspection ports to check inside only when this can be done safely. Notice whether inspection ports have been painted over or permanently sealed.

 5.4.5.1 - Filtering Systems

Observe the firm's filtering systems and evaluate the cleaning methods (or replacement intervals of disposable filters) and schedules. Check types of filters used. There have been instances where firms have relied on household furnace type filters.

 5.4.5.2 - Sanitation of Machinery

Check the sanitary condition of all machinery. Determine if equipment is cleaned prior to each use and the method of cleaning. If the firm rents or leases equipment on a short-term basis, report prior cleaning procedures. Equipment may have been used for pesticides, chemicals, drugs, etc., prior to being installed and could therefore be a source of cross-contamination.

 5.4.5.3 - Conveyor Belt Conditions

Inspect conveyor belts for build-up of residual materials and pockets of residue in corners and under belts. Look in inspection ports and hard-to-reach places inside, around, underneath, and behind equipment and machinery for evidence of filth, insects, and/or rodent contamination. Chutes and conveyor ducts may appear satisfactory, but a rap on them with the heel of your hand or a rubber mallet may dislodge static material, which can be examined. See IOM 4.3.7.6 for procedure on taking In-line Sample Subs.

 5.4.5.4 - Utensils

Determine how brushes, scrapers, brooms, and other items used during processing or on product contact surfaces are cleaned, sanitized and stored. Evaluate the effectiveness of the practices observed.

 5.4.5.5 - Mercury and Glass Contamination

Be alert for improper placement or inadequately protected mercury switches, mercury thermometers, or electric bulbs. Breakage of these could spray mercury and glass particles onto materials or into processing machinery.

 5.4.5.6 - UV Lamps

If firm is using ultra violet (UV) lamps for bacteria control, check if it has and uses any method or meters to check the strength of UV emissions. If so, obtain methods, procedures, type equipment used, and schedule for replacement of weak UV bulbs.

 5.4.5.7 - Chlorine Solution Pipes

In plants where chlorine solution is piped, check on type of pipe used. Fiberglass reinforced epoxy pipe has been observed to erode inside through the action of the chlorine solution. This poses a threat of contamination from exposed glass fibers. Pipes made with polyester resin do not deteriorate from this solution.

 5.4.5.8 - Sanitation Practices

Observe sanitizing practices throughout the plant and evaluate their effectiveness, degree of supervision exercised, strength, time, and methods of use of sanitizing agents. Determine the use, or absence of, sanitizing solutions both for sanitizing equipment and utensils as well as for hand dipping. If chlorine is used, 50 ppm - 200 ppm should be used for equipment and utensils, while a 100 ppm will suffice for hand dipping solutions. Sanitizing solutions rapidly lose strength with the addition of organic material. The strength of the solution should be checked several times during the inspection.

 5.4.6 - MANUFACTURING PROCESS

Where helpful to describe equipment and processes, draw flow plans or diagrams to show movement of materials through the plant. Generally a brief description of each step in the process is sufficient. List all quality control activities for each step in the process and identify Critical Control Points. Provide a full description when necessary to describe and document objectionable conditions, or where the assignment specifically requests it.

Observe whether hands and equipment are washed or sanitized after contact with unsanitized surfaces. For example:

  1. Workers do general work, then handle the product;
  2. Containers contact the floor, then are nested or otherwise contact product or table surfaces;
  3. Workers use common or dirty cloths or clothing for wiping hands;
  4. Product falls on a dirty floor or a floor subject to outside foot traffic and is returned to the production line.

Be alert for optimum moisture, time and temperature conditions conducive to bacterial growth.

In industries where scrap portions of the product are re-used or re-worked into the process (e.g., candy and macaroni products), observe the methods used in the re-working and evaluate from a bacteriological standpoint. Re-working procedures such as soaking of macaroni or noodle scrap to soften or hand kneading of scrap material offers an excellent seeding medium for bacteria.

When a product is processed in a manner which destroys micro-organisms, note whether there are any routes of recontamination from the "raw" to the processed product (e.g. dusts, common equipment, hands, flies, etc.).

 5.4.6.1 - Ingredient Handling

Observe the method of adding ingredients to the process. Filth may be added into the process stream from dust, rodent excreta pellets, debris, etc. adhering to the surface of ingredient containers. Evaluate the effectiveness of cleaning and inspectional operations performed on the materials prior to or while adding to the process. Determine specific trimming or sorting operations on low quality or questionable material. Observe and report any significant lags during the process or between completion of final process and final shipping. For example, excessive delay between packing and freezing may be a factor in production of a violative product.

 5.4.6.2 - Formulas

The Act does not specifically require management to furnish formula information except for human drugs, restricted devices and infant formulas. Nonetheless, they should be requested especially when necessary to document violations of standards, labeling, or color and food additives. Management may provide the qualitative formula but refuse the quantitative formula.

If formula information is refused, attempt to reconstruct formula by observing:

  1. Product in production,
  2. Batch cards or formula sheets,
  3. Raw materials and their location.

Any refusal to furnish requested information is reported in your EIR under the refusal heading.

 5.4.6.3 - Food Additives

Refer to the food additives programs in CP (Chapter 9) for instructions on conducting establishment inspections of firms manufacturing food additive chemicals. Information is also available in ORA'sHighlighted to denote updated text "Guide to Inspections of Manufacturers of Miscellaneous Food Products - Volume II.

When making food plant inspections direct your evaluation of food additives only to those instances of significant violation or gross misuse.

Routine inspectional coverage will be directed primarily to the following two types of additives:

  1. Unauthorized and illegal as listed in the Food Additive Status List (safrole, thiourea, et al), and
  2. Restricted as to amount in finished food.

Because of special problems, exclude the following additives from coverage during routine inspections:

  1. Packaging materials,
  2. Waxes and chemicals applied to fresh fruit and vegetables,
  3. Synthetic flavors and flavoring components except those banned by regulations or policy statements (these products will be covered under other programs), and
  4. Food additives in feeds (these products will be covered under other programs).

The Food Additives Status List (FASL) found on the CFSAN website contains an alphabetical listing of substances, which may be added directly to foods or feeds and their status under the Food Additives Amendment and Food Standards. In addition, a few unauthorized or illegal substances are included.

You may encounter substances not included in the Food Additives Status List (FASL). Such substances will include:

  1. Obviously safe substances not on the list of items generally recognized as safe (GRAS), which are not published in the regulations, i.e., salt, cane sugar, corn syrup, vinegar, etc.;
  2. Synthetic flavoring substances because of their indefinite status;
  3. Substances pending administrative determination,
  4. Substances granted prior sanction for specific use prior to enactment of the Food Additives Amendment.

Give primary attention to unauthorized substances. Document and calculate levels of restricted-use additives in finished food only where gross misuse or program violations are suspected as follows:

  1. List ingredients, which may be restricted substances or food additives, and determine their status by referring to the current FASL. Report complete labeling on containers of these substances.
  2. Obtain the quantitative formula for the finished product in question.
  3. Determine the total batch weight by converting all ingredients to common units.
  4. Calculate the theoretical levels in the final product of all restricted or unauthorized ingredients from the formula by using the Food Additives Nomographs. See IOM Exhibit 5-11.
  5. Determine probable level of restricted ingredients by observing the weight of each ingredient actually put into the batch.

 5.4.6.4 - Color Additives

Evaluate the status of color additives observed during each establishment inspection by using the Color Additive Status List and the Summary of Color Additives Listed in the United States in Food, Drugs, Cosmetics, and Medical Devices.  Both of these links can be found on the CFSAN website. These lists provide the current status and use limitations of most color additives likely to be found in food, drug, device, or cosmetic establishments.

Stocks of delisted and uncertified colors may be found in the possession of manufacturers where there is no evidence of misuse. Advise the firm of the status of these colors. If management wishes to voluntarily destroy such colors, witness the destruction and include the facts in your EIR. If the firm declines to destroy the colors, determine what disposition is planned, i.e., use in non-food, non-drug, non-cosmetic or non-medical device products. The validity of certification information can be checked by accessing the online Color Certification Database system maintained by the Office of Cosmetics and Colors or contact Ray Decker, Director, Division of Color Certification and Technology, HFS-105, by e-mail at raymond.decker@fda.hhs.gov to be granted user privilege.

Where decertified or restricted-use colors are used in manufacturing food, drug, device, or cosmetics products, proceed as follows:

  1. Collect an Official Sample consisting of the color and the article in which it is being used. Make every effort to collect interstate shipments of the adulterated product before attempting to develop a 301(k) or 301(a) case. When regulatory action is an alternative, obtain sufficient interstate records to cover both the color and the basic ingredients of the manufactured product. Refer to IOM Sample Schedule, Chart 9 - Sampling Schedule for Color Containing Products for guidance.
  2. Document the use of decertified colors after the decertifying date. Documentation should include batch formula cards, employee statements, code marks indicating date of manufacture, color certification number, etc. The presence of color in the finished product will be confirmed by your servicing laboratory.

 5.4.6.5 - Quality Control

The objective of quality control is to ensure the maintenance of proper standards in manufactured goods, especially by periodic random inspection of the product. Your inspection should determine if the firm's quality control system accomplishes its intended purpose. Establish responsibility for specific operations in the control system. Determine which controls are critical for the safety of the finished product.

 5.4.6.5.1 - INSPECTION SYSTEM

Determine what inspectional control is exercised over both raw materials and the processing steps. Such inspection may vary from simple visual or other organoleptic examination to elaborate mechanical manipulation. Determine what inspection equipment is used, i.e., inspection belts, sorting belts, grading tables, ultraviolet lights, etc. Ascertain its effectiveness, maintenance or adjustment schedules. Where indicated, determine the name of the manufacturer of any mechanical inspection device and the principles of its operation.

Evaluate the effectiveness of the personnel assigned to inspection operations. Determine if the inspection belts or pick-out stations are adequately staffed and supervised.

Determine the disposition of waste materials, which are unfit for food or feed purposes.

 5.4.6.5.2 - LABORATORY TESTS

Describe routine tests or examinations performed by the firm's laboratory and the records maintained by the firm. Determine what equipment is available in the laboratory and if it is adequate for the purpose intended. If the firm uses a consulting laboratory, determine what tests are performed and how often. Review laboratory records for the period immediately preceding the inspection.

 5.4.6.5.3 - MANUFACTURING CODE SYSTEM

Obtain a complete description of the coding system with any necessary keys for interpretation. Provide an example by illustrating the code being used at the time of the inspection. (See 21 CFR 113.60(c) and 114.80(b)). Report coding systems, which require the use of ultra-violet light for visibility. Hermetically sealed containers of low acid processed food must be coded in a manner clearly visible. (See 21 CFR 113.60). Check 21 CFR 113 and 114 for regulations on coding for the type plant you are inspecting.

 5.4.6.6 - Packaging and Labeling

Evaluate storage of packaging materials including protection from contamination by rodents, insects, toxic chemicals or other materials. Appraise the manner in which containers are handled and delivered to the filling areas. Determine if there is likelihood of chipping of glass or denting, puncturing, tearing, etc., of packaging materials. Observe the preparation of containers prior to filling. Consider any washing, steaming, or other cleaning process for effectiveness. Determine, in detail, the use of air pressure or other cleaning devices.

 5.4.6.6.1 - QUANTITY OF CONTENTS

If slack fill is suspected, weigh a representative number of finished packages. See IOM 4.3.8 for net weight procedure. Sets of official weights are available in the district servicing laboratory. These may be used to check the accuracy of firm's weighing equipment.

 5.4.6.6.2 - LABELING

Check the sanitary condition of labelers and equipment feeding cans to, and away from, the labeler. Determine if old product is present on any equipment which touches the can end seams, in the presence of moisture carry-over from the can cooling operation. Check availability of floor drains in the labeling area. Absence of floor drains could indicate infrequent cleaning of the equipment unless it is physically moved to another area for cleaning.

Determine what labels are used and what labeling is prepared or used to accompany or promote the product. Obtain specimens of representative labels and labeling including pamphlets, booklets, and other promotional material.

  5.4.6.6.3 – NUTRITIONAL AND ALLERGEN LABELING

See document "Guide to Nutritional Labeling and Education Act (NLEA) Requirements" for guidance. See Guidance, Compliance & Regulatory Information > Food Allergen Labeling and Consumer Protection Act of 2004 (Public Law 108-282, Title II) for guidance on Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requirements.

 5.4.7 - SANITATION

Documented observation of the conditions under which food products are processed, packed, or stored is essential to the proper evaluation of the firm's compliance with the law. This involves the determination of whether or not insanitary conditions contribute to the product being adulterated with filth, rendered injurious to health, or whether it consists in whole or in part of a filthy, putrid or decomposed substance.

Observations that dirt, decomposed materials, feces or other filthy materials are present in the facility and there is a reasonable possibility these filthy materials will be incorporated in the food are also ways of determining products may have become contaminated.

 5.4.7.1 - Routes of Contamination

It is not sufficient to document only the existence of insanitary or filthy conditions. You must also demonstrate how these conditions contribute or may contribute to contaminating the finished product. Investigate and trace potential routes of contamination and observe all means by which filth or hazardous substance may be incorporated into the finished product. For example, defiled molding starch in a candy plant may contribute filth to candy passing through it, or filth in insect or rodent contaminated raw materials may carry over into the finished product. IOM Section 4.3.7 contains instructions on sample collection techniques for adulteration violations, including instructions for field exams and sample collections to document evidence of rodent, insect, etc., contaminated lots, and instructions for in-line sampling, including bacteriological samples. Finished product sample sizes for filth and micro collections can be found in the applicable Compliance Program (CP) or DFI "Guide to Inspections of ***."

 5.4.7.1.1 - INSECTS

Insect contamination of the finished product may result from insect infested raw material, infested processing equipment or insanitary practices, and by insanitary handling of the finished product. When routes of contamination with insect filth are encountered, identify the insects generally, e.g., weevils, beetles, moths, etc. If qualified, identify as to species. You must be correct in your identification. See IOM Appendix A.

 5.4.7.1.2 - RODENTS

Rodent contamination of the finished product may result from using rodent defiled raw materials, exposure to rodents during processing, and by rodent depredation of the finished product. When evidence of rodents are discovered, you should thoroughly describe its composition, quantity, estimated age and location. Explain its significance and potential for product contamination. See IOM Section 4.3.7.4.2.3 – Summary of Sample for Rodent Evidence.

 5.4.7.1.3 - PESTICIDES

Pesticide contamination of the finished product may be the result of mishandling of food products at any stage in manufacturing or storage. The use of toxic rodenticides or insecticides in a manner, which may result in contamination, constitutes an insanitary condition. Where careless use of these toxic chemicals is observed, take photographs and provide other documentation showing its significance in relation the food products.

Additional guidance can be found in 21 CFR as follows:

  1. Part 110.20(b) - Plant Construction and Design,
  2. Part 110.40(a) - Equipment and Utensils,
  3. Part 110.35(c) - Pest Control,
  4. Part 110.10(b) - Personnel Cleanliness.

Additional guidance can be found in 40 CFR Part 180 - Tolerances and Exemptions From Tolerances For Pesticides in Food Administered by The Environmental Protection Agency as follows:

  1. Part 180.521 - Fumigants for grain-mill machinery; tolerances for residues, and
  2. Part 180.522 - Fumigants for processed grains used in production of fermented malt beverages; tolerances for residues.

Be alert for:

  1. Possible PCB contamination. Articles containing PCBs (e.g., transformers, PCB containers stored for disposal, electrical capacitors) must be marked with prescribed labeling to show they contain PCBs. No PCB-containing heat exchange fluids, hydraulic fluids or lubricants are allowed used in food plants. All PCB storage areas must be marked to show the presence of PCBs. Observe food plant transformers for possible leakage. If observed, determine if food items are stored in the area, and sample for PCB contamination. If PCBs are encountered in a food establishment, immediately advise management this is an objectionable condition and advise your supervisor.
  2. Possible mix-up of pesticides or industrial chemicals with food raw materials.
  3. Improperly stored pesticides or industrial chemicals (lids open, torn bags in close proximity to foods, signs of spillage on floors, pallets, shelves, etc.).
  4. Incorrect application methods including excessive use. Many pesticide labels give instructions for use and precautions on the container.
  5. Improper disposal or reuse of pesticide or industrial chemical containers.
  6. Evidence of tracking powder or improper use of bait stations or baited traps.
  7. Improper handling of equipment. Movable or motorized equipment used for handling possible chemical contaminants should not be used for handling food products unless they are thoroughly decontaminated. For example, fork-lifts moving pallets of pesticides should not also be used to move pallets of flour, etc.
  8. Use of unauthorized pesticides.
  9. Use of foods treated with pesticides and marked "Not For Human Consumption" (e.g., Treated seed wheat, etc.).
  10. Noticeable odor of pesticides.
  11. Careless use of machinery lubricants and cleaning compounds.
  12. Chemical contaminants in incoming water supply.

When inspecting products with a known potential for metals contamination, determine whether the firm tests for such contamination in raw materials.

Determine who administers the firm's rodent and insect control program. Determine responsibility for the careless use of toxic materials.

If pesticide misuse is suspected, obtain the following information;

  1. Name of exterminator and contract status,
  2. Name of pesticide,
  3. Name of pesticide manufacturer,
  4. EPA registration number,
  5. Active ingredients, and
  6. Any significant markings on pesticide containers.

Fully document the exact nature of any pesticide or industrial chemical contamination noted or suspected. If samples are collected to document misuse, exercise caution to prevent contamination of the immediate area of use, product or yourself.

 5.4.7.1.4 - OTHER

Contamination of food products by bats, birds and/or other animals is possible in facilities where food and roosting facilities are available. Examine storage tanks, bins, and warehousing areas to determine condition and history of use. There have been instances where empty non-food use containers were used for food products.

 5.4.7.2 - Microbiological Concerns

During the inspection, identify likely sources and possible routes of contamination of the product with pathogenic microorganisms.

See IOM sections 4.3.7.6 and 4.3.7.7 for sampling guidance.

You should become familiar with the flow of the process and determine the potential trouble spots, which may be built into the operation. To document the establishment is operating under unsanitary conditions which may result in the presence of pathogens in food, it is necessary to show that the manufacturing process may have, or has contributed to the bacterial load of the product. See IOM 4.3.7.7 for instructions on sampling for pathogens. If there are several products being prepared at once, do not try to cover the entire operation during one inspection. Select the product which has the greatest potential for bacterial contamination or which poses the greatest risk for the consumer.

It is extremely important for each EIR to contain complete, precise, and detailed descriptions of the entire operation. The EIR must be able to stand alone without the analytical results, which serve to support the observations.

Observations made during the inspection must be written in clear and concise language. The EIR will be reviewed in conjunction with analytical results of in-line, environmental and finished production samples collected. Based on this review and other information which may be available, the district must then decide if the total package will support a recommendation for regulatory action.

Each inspection/process will be different, but the techniques for gathering the evidence will be the same. However, the critical points in the operation should always be defined and special attention given to these areas.

Depending on the type of product being produced and the process being used, it may be useful to record the time each critical step takes, encompassing the entire processing period from beginning to end, with correlating temperature measurements. This should be done especially for products which may support the growth of microbial pathogens. During the entire inspection, be aware of and document delays in the processing of the product (e.g., temperature of product prior to, during and after the particular processing step, and the length of time the product has been delayed prior to the next step). Also be aware of and document potential routes of environmental contamination.

Some products receive a thermal process at the end of production, which may reduce bacterial counts to or near zero, although post process contamination is still possible through cross-contamination from the environment. Include detailed observations of heating step, temperature, length of time, controls and documentation used/not used by the firm. Even in the presence of end-product thermal processing, there is a regulatory significance to insanitary conditions prior to cooking, coupled with increases in bacterial levels demonstrated through in-line sampling.

 5.4.7.2.1 - PROCESSING EQUIPMENT

Document the addition, or possible addition of pathogenic microorganisms from accumulated material due to poorly cleaned and/or sanitized processing equipment

Observe and report the firm's clean up procedures and the condition and cleanliness of food contact surfaces before production starts, between production runs and at the end of the day. Document any residue on food contact surfaces of equipment, especially inside complex equipment not easily cleaned and sanitized. Report firms clean-up procedures in depth, since it may lend significance to insanitary conditions of residues on the plant machinery which are left to decompose overnight or between shifts. Where possible, observe equipment both before and after cleaning to assess it adequacy. Observations of residues on plant machinery can dramatically document the addition of pathogenic microorganisms, if present, into the product.

Identify any vectors of contamination (e.g. birds, rodents, insects, foot traffic, etc.), and describe sources and the routes of contamination from them to the product. Support this with your actual observations.

 5.4.7.2.2 - EMPLOYEE PRACTICES

Document any poor employee practice and how they have or would provide a route for contaminating the product. For example, did employees (number/time of day) fail to wash and sanitize their hands at the beginning of processing, after breaks, meals, or after handling materials likely contaminated with a microbial pathogen, etc.; and then handle the finished product. Did employees handle product in an insanitary manner (cross contaminating raw product with cooked product, etc., how many, how often).

 5.4.7.3 - Storage

Evaluate the storage of finished products in the same manner as for raw materials. Determine if products are stored to minimize container abuse, facilitate proper rotation, and adherence to the storage requirements. This includes refrigeration temperatures, critical temperature tolerance, aging of products, and proper disposition of distressed stock.

 5.4.7.3.1 - FOOD TRANSPORT VEHICLES

During food sanitation inspections, (See IOM 5.2.2.2 regarding issuance of FDA 482, Notice of Inspection while inspecting vehicles.), conduct inspections of food transport vehicles to include:

  1. Evidence of insanitary conditions,
  2. Conditions which might lead to food adulteration,
  3. Physical defects in the vehicle,
  4. Poor industry handling practices.

The following types of transport vehicles should be covered:

  1. Railroad boxcars, both refrigerated and non-refrigerated, and hopper cars.
  2. Any type of truck used to transport foods; both refrigerated and non-refrigerated.
  3. Use extreme caution, if it is necessary to inspect tank railcars or tank trucks. Usually this coverage will be limited to determining what was transported in the tank previously and was the tank cleaned and/or sanitized as necessary between loads.
  4. Vessels used to transport food in I/S commerce. Direct coverage primarily to intercoastal type vessels, including barges.

Coverage should be limited to food transport vehicles used for long haul (I/S) operations. Long haul vehicles are defined as those which travel at least 150 miles between loading and unloading or which do not return to the point of loading at the end of the day.

Regulatory actions are possible if unfit cars are loaded and, as a result of loading, adulteration occurs. Fully document any violations noted with appropriate samples and photographs. When vehicle insanitation is observed, it is imperative the carrier's and shipper's responsibility for the food adulteration be documented by appropriate evidence development, such as:

  1. The nature and extent of the conditions or practices, and
  2. The mechanical or construction defects associated with the food transport vehicle.
  3. Individual responsibility for vehicle or trailer cleaning, vehicle assignments, load assignments, etc.

If gathering evidence about a single carrier, seek a series of occurrences at numerous locations involving as many different shippers as possible.

Basically two types of vehicles will be covered.

 5.4.7.3.2 - VEHICLES AT RECEIVERS

When inspecting receivers of food products, examine the food transport vehicle prior to or during unloading. Make a preliminary assessment of food product condition, then inspect the vehicle after unloading to determine its condition and whether the unloaded food may have been contaminated during shipment. If the food appears to have been adulterated, collect a sample(s) for regulatory consideration. Samples collected from vehicles, which have moved the product in interstate commerce are official samples. You may also collect Documentary (DOC) Samples from the vehicle to substantiate the route of contamination.

 5.4.7.3.3 - VEHICLES AT SHIPPERS

When inspecting shippers of food products, examine the food transport vehicle just prior to loading to determine its sanitary/structural conditions. If the vehicle has significant sanitation or structural deficiencies, notify the shipper of these conditions and of the possibility of product adulteration. If the shipper loads food aboard the vehicle, alert your supervisor so he/she can contact the FDA District where the consignee is located for possible follow-up. You may also collect samples from the load. These samples will become official when the Bill of Lading is issued.

 5.4.8 - DISTRIBUTION

Report the general distribution pattern of the firm. Review interstate shipping records or invoices to report shipment of specific lots. If access to invoices or shipping records is not possible, observe shipping cartons, loading areas, order rooms, address stencils, railroad cars on sidings, etc., to determine customer names, addresses and destination of shipments. If no products are suspect, obtain a listing of the firm's larger consignees.

 5.4.8.1 - Promotion and Advertising

Determine the methods used to promote products and how the products reach the ultimate consumer. Determine what printed promotional materials are used and whether they accompany the products or are distributed under a separate promotional scheme. Check on the possibility of oral representations, i.e., door-to-door salesmen, spieler, etc. and obtain copies of brochures, pamphlets, tearsheets, instructions to salespersons, etc. Where indicated, obtain the lecture schedule of any promotional lecture program. If applicable, determine the general pattern of the media used for promotion and advertising.

 5.4.8.2 - Recall Procedure

Determine the firm's recall procedure. Audit enough records to determine the effectiveness of established procedures. Report if there is no recall procedure.

 5.4.8.3 - Complaint Files

Review the firm's complaint files. Where possible, copy the names and addresses of representative complainants; include a brief summary of each significant complaint in the EIR.

Identify who reviews complaints and their qualifications. Describe the criteria used by the firm in evaluating the significance of complaints and how they are investigated. Determine if records are kept of oral and telephone complaints. See IOM 5.2.8 for discussion of complaints with management and IOM 5.10.4.3.11 for reporting of complaints in the EIR.

Complaints may not be filed in one specific file, but may be scattered throughout various files under other subject titles including Product name; Customer name; Injured party name; Adjustment File; Customer Relations; Repair orders, etc.

During the inspection investigate all complaints contained on FDA-2516 and FDA-2516a forms in the firm's district factory jacket. See IOM 5.2.8, 5.4.1.1 and 5.10.4.3.11.

 5.4.9 - OTHER GOVERNMENT INSPECTION

See IOM 3.1 for general procedures on cooperating with other Federal, State, and local officials.

During Establishment Inspections determine the specific type of inspection service and inspecting units, which cover the firm, such as the name of the federal, state, county, or city health agency or department. Obtain the name and title of the inspectional official, and general method of operation.

 5.4.9.1 - Federal

Do not inspect firms, or those portions of the plant, subject to compulsory, continuous inspection under USDA's Meat Inspection ActPoultry Products Inspection Act, or Egg Products Inspection Act, except on specific instructions from your supervisor or assignment document.

Ingredients or manufacturing processes common to both USDA and FDA regulated products should be inspected by FDA. See IOM 3.2.1.3 for FDA-USDA Agreements in specific areas.

Provide routine FDA coverage of such firms as breweries and wineries, which may be intermittently inspected on a compulsory basis by the U.S. Treasury Department, U.S. Public Health Service, or other agencies.

All products inspected under the voluntary inspection service of the Agriculture Marketing Service (AMS), USDA, and the National Marine Fisheries Service (NMFS), US Department of Commerce, are subject to FDA jurisdiction and are usually given routine coverage. However, formal written Agreements or Memoranda of Understanding between FDA and other agencies are often executed and may govern the agreeing agencies' operations on this type of inspected plants. When assigned this type of plant for inspection, always check to see if an Agreement or a Memorandum of Understanding exists between FDA and the agency involved to determine the obligations of both agencies. See IOM 3.1.2.1  and 3.2.

If you are assigned to cover a Federally Inspected plant which is under either compulsory or voluntary inspection, present your credentials and an FDA 482 "Notice of Inspection" to management and:

  1. Identify yourself to the inspector(s) and invite him/her to accompany you on the inspection but do not insist on their participation.
  2. At the conclusion of the inspection, offer to discuss your observations and provide the in-plant inspector with a copy of your Inspectional Observations (FDA 483).

 5.4.9.2 - State and Local

State and local officials usually have extensive regulatory authority over firms in their area regardless of the interstate movement or origin of the food products involved. Joint FDA-State or local inspections are frequently conducted. These are usually arranged by district administrative or supervisory personnel. See IOM 3.1.2 and 3.3.

 5.4.9.3 - Grade A Dairy Plant Inspections

If you are assigned to conduct an inspection or sample collection at a milk plant that is covered under the Grade A Milk program, which has milk and milk products labeled and sold as Grade A, you should verify the need to complete the assignment with your supervisor and the Regional Milk Specialist. Grade A milk plants, milk, and milk products labeled as Grade A are inspected by state inspectors and check rated by FDA's Regional Milk Specialists and you should not inspect these Grade A milk and milk products. Milk plants in the Grade A Milk program and covered by the Interstate Milk Shippers (IMS) program are identified in the Interstate Milk Shippers List of Sanitation Compliance and Enforcement Ratings on the following FDA web site http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/MilkSafety/FederalStatePrograms/InterstateMilkShippersList/default.htm. This reference lists the specific milk plant and each milk and milk product covered under the IMS program. These Grade A milk and milk products are covered by a MOU between the FDA and the states, which places primary inspectional responsibility with the state.

There are situations where you will need to conduct an inspection in a Grade A milk plant and cover products they manufacture which do not carry the "Grade A" designation (such as juices). Fluid milk and milk products, cultured/ acidified milk and milk products, eggnog, cream(s) sour cream, and yogurt are all considered Grade A and are required to be labeled as Grade A. The Grade A milk plant may also manufacture milk and milk products which are optional for the Grade A designation, depending upon the particular state. Cottage cheese is considered a Grade A optional milk product. If the state does not require the Grade A designation for cottage cheese, then the cottage cheese will not be included in the IMS listing of Grade A milk and milk products for that specific milk plant. Also, if the Grade A milk plant is manufacturing condensed or dried milk or milk products or condensed or dried whey or whey products, which are optionally labeled as Grade A, then those milk or milk products must be IMS listed and are covered under the Grade A Milk Program. Note: This same Grade A milk plant may also be manufacturing non-Grade A versions of these condensed/dried milk or milk products or condensed/dried whey or whey products.

 5.4.10 - FOOD STANDARDS

The Federal Food, Drug, and Cosmetic Act requires the Secretary of Health and Human Services to promulgate reasonable definitions and Standards for food to promote honesty and fair dealing in the interest of consumers. When a Standard becomes effective, it establishes the common or usual name for the article, defines the article and fixes its standard of identity. It is then the official specification for the food. The food industry actively participates in the development of a Standard, and supplies much of the data upon which the regulation is based.

The Food Standards (FS) Inspection is made to obtain data for use, together with information from other sources in developing a Food Standard. Food Standard inspections are also made to determine a firm's compliance with food standards regulations, when manufacturing a standardized food.

 5.4.10.1 - Food Establishment Inspection

Food Standard (FS) inspection assignments usually originate from CFSAN. When an inspection is planned for the purpose of collecting data to support a proposed food standard regulation, the district may elect to advise the firm, if the CFSAN has not already done so. If the firm selected does not choose to cooperate, it may be necessary to visit additional plants in order to obtain the desired information. Selection of additional firms should be done in consultation with the CFSAN.

Some firms often contend their entire process and formulas are "trade secrets". Attempt to persuade management the term "trade secret" should only be used to cover the process and/or quantitative-qualitative formulation which is truly unique to the firm. In instances where the firm is reluctant to release any of the information requested, point out FDA will, within the limits of the Freedom of Information Act, make every effort to preserve the confidentiality of the composition, make-up, and production levels of the product through the use of codes, which cannot be traced back to the firm. Include as much of the compositional and processing information as you can in the body of the report, without violating the firm's confidence.

 5.4.10.2 - Food Inspection Report

FS EIR's may be used as exhibits at public hearings and are subject to review by any interested party.

Three copies of the report are prepared. The original and one copy will be submitted to the CFSAN and one copy kept for the district file. Sign the original and duplicates of the first and last pages of each report sent to the Center.

Divide the report into three sections.

 5.4.10.2.1 - ESTABLISHMENT INSPECTION RECORD (EI RECORD)

In order to relate the sections of the report to each other and to any assignments, and to assure any parts of the reports made public will not be identified as to the name of the firm or individuals therein, each district will set up a master list of numbers. One number will be assigned to each establishment covered, e.g., "BLT FS-3". For each FS Inspection place the assigned number next to the firm name on the EI Record. All other pages of the report shall be identified only by this number, the name of the commodity, and date. Example: "EIR Frozen Fish Sticks 10-3-87 BLT FS-3". This indicates a FS EI of frozen fish sticks conducted by Baltimore District on 10-3-87 in a plant designated as #3.

Where a producer may be reluctant to release any of the information requested, point out the FDA will, within the limits of the FOIA, make every effort to preserve the confidentiality of the composition, make-up, and production levels of his product through the use of codes, which cannot be traced back to the firm.

 5.4.10.2.2 - BODY OF REPORT

Prepare the body of the report following the narrative outline as for any other food EIR except for the restrictions below.

The body of the FS report should also contain information in regard to the approximate annual value and volume as well as the percent of interstate business for each product covered. This is necessary because the coversheet, which contains this information, identifies the firm and will not be made public. Processes and the listing of raw materials used by the firm, which are not restricted by the term "trade secret" should be included. Any opinions, recommendations, or other information obtained or offered by individuals interviewed should be reported. Any suggestions made by individuals interviewed regarding what should be placed in the Standards for the products covered should be included. All individuals interviewed, firm name, etc. should have an identifying code assigned.

The body of the report should not include names and titles of individuals, (including USDA, USDI, or other inspectors), trade secret information, labeling, trade names, formulas, sample numbers, firm name or location of plant (other than by state or region), shipments, or other distribution information, legal status, or regulatory history. This information will be placed in the "Special Information" section of the report.

 5.4.10.2.3 - SPECIAL INFORMATION SECTION

This is a separate attachment to the EIR which lists the names and titles of individuals (including other government inspectors) and firms with a reference code for each. The EIR should refer only to "Mr. A.," "Mr. B.," "Firm X," "Firm Y", etc. Do not use the firm or individual's actual initials in the body of the report. Include all information excluded from the body of the report and mount all labels obtained during the EI Labels may be quoted in the body of the report, but do not identify the firm. List the "Special Information Sheet" in the FACTS endorsement section as an enclosure.

Supplemental Reports - If, because of an additional visit or visits to the same firm on the same project, it is necessary to prepare another EIR, flag the report with the same number as assigned to the original report. For example, mark the EI Record "BLT FS-3 Supplemental Report", and the remaining pages, "EIR Frozen Fish Sticks 10-25-87 BLT FS-3 Supplemental Report."

 5.4.10.3 - Violative Inspections

When an inspection made in connection with the Food Standards project shows insanitary or other conditions which are not germane to the assignment or in the District's opinion suggests regulatory action, an appropriate narrative of the violative conditions should be prepared as a Regulatory Addendum.

 5.4.11 - RE-INSPECTIONS CONDUCTED UNDER SECTION 743 OF THE FD&C ACT

The FD&C Act, as amended by the FDA Food Safety Modernization Act of 2011 (FSMA) (P.L. 111-353) authorizes FDA to collect fees to cover costs related to specific domestic and foreign food facility re-inspections. FDA announced our intent to collect these fees beginning in fiscal year 2012 via a Federal Register Notice issued on August 1, 2011 (FRN).

Section 743 of the FD&C Act authorizes FDA to assess and collect fees to capture 100% of the costs related to certain domestic and foreign food facility re-inspections. The fee for re-inspection is to cover re-inspection related costs when an initial inspection, initiated on or after October 1, 2011, has identified violations “materially related to food safety requirements” of the FD&C Act. The re-inspection must be conducted specifically to determine whether compliance has been achieved.

 5.4.11.1 - Conducting Inspections for which Fees can be Assessed

To be eligible for a re-inspection for which fees can be assessed under section 743 of the FD&C Act, a firm must have a previous inspection with a final classification of Official Action Indicated (OAI) initiated on or after October 1, 2011. These inspectional assignments should be generated by the District Compliance Branch as part of the OAI follow-up inspection process. The assignment will indicate that the inspection is a Reinspection for violations materially related to food safety requirements of the FD&C Act.

 5.4.11.1.1 - REGULATED INDUSTRY NOTIFICATION

During every food and feed facility inspection, a copy of the Information Sheet – Assessment of Re-Inspection User Fees by the FDA, should be provided to firm management at the same time the FDA-482, Notice of Inspection, is issued. Issuance of the Information Sheet should be documented as per section 5.10.4.3.3 - ADMINISTRATIVE DATA in the Establishment Inspection Report (EIR).

For foreign facility inspections, the Consumer Safety Officer (CSO) will provide copies of both the English version and the translated version, if available, during the opening interview of the inspection. During a foreign facility inspection, the CSO shall identify and document the United States (US) Agent for that facility in the Administrative Data section of the EIR.

When Administrative and/or Enforcement actions are taken, standard language will be included in the official post-inspectional correspondence informing responsible firm management that subsequent re-inspections for the violations documented will be subject to fees under section 743 of the FD&C Act. When initiating a reinspection, remind firm management of the fees that will be incurred for this inspection. Additionally, provide firm management with an Information Sheet – Assessment of Re-Inspection User Fees when issuing the FDA-482, Notice of Inspection and document the issuance in the EIR.

Firm officials can direct any billing questions to the “ORA FSMA User Fee Billing” email address (ORAFSMAUserFeeBilling@fda.hhs.gov).

 5.4.11.1.2 - RE-INSPECTION ASSIGNMENT GENERATOR

The District Compliance Branch will generate OAI follow-up inspection assignments in FACTS.  The re-inspection designation should be noted in the FACTS assignment subject line.  The re-inspection designation in FACTS for foreign inspections will be accomplished by DFFPOI or DMPTIHighlighted to denote updated text upon communication from the respective Center. In the Background section of the FACTS assignment, include an affirmation that the violations are materially related to a food safety requirement of the FD&C Act.

 5.4.11.1.3 - RE-INSPECTION REPORTING

When assigned a reinspection for which FDA can assess fees under section 743 of the FD&C Act, the lead CSO will be will be responsible for printing a copy of the FACTS Assignment sheet and the FSMA User Fee Re-Inspection Time Reporting sheet. The FACTS Assignment Sheet must be printed prior to setting the FACTS inspection assignment to Complete. Each CSO involved in preparing, conducting, and reporting a FSMA fee re-inspection must accurately complete, sign and date the FSMA User Fee Re-inspection Timesheet. Time to be captured includes inspection preparation, travel time to and from the inspection site (including travel time to a temporary duty station), inspection and sampling activities, field exams, report writing, and review of firm responses. Record each date activities are performed on the FSMA User Fee Re-inspection Time Recording sheet. Record all operational hours spent on issues materially related to food safety requirements of the FD&C Act. If other issues not materially related to food safety are covered during the re-inspection, do not record those hours on the User Fee Re-inspection Time Reporting sheet, but do capture this time in FACTS Inspection Accomplishment Hours for the inspection as per usual procedures. Upon completion of the inspection and post inspectional reporting activities, submit the completed FSMA User Fee Re-inspection Time Reporting Sheet to your supervisor for review with the completed EIR and FACTS Assignment sheet.

When reporting time into the FACTS database, the “Reimbursable” check box must be checked on the Inspection Accomplishment Hours screen. Exhibit 5-18 shows where this box is located.

When a supervisor reviews the EIR and records the FACTS endorsement and initial classification in the FACTS EI Record, they must confirm the Reimbursable check box is checked in FACTS. The supervisor will complete the FSMA Re-inspection Cover Sheet and submit this document with the FSMA User Fee Re-Inspection Time Reporting sheet and FACTS Assignment Sheet completed by the investigator. The supervisor should ensure separation of any time spent on inspectional issues not materially related to a food safety requirement of the FD&C Act. After review, the supervisor will sign and date the FSMA User Fee Re-Inspection Time Reporting sheet and Coversheet. For a foreign re-inspection, the supervisor should ensure that the US Agent information is captured in the FSMA Re-Inspection Cover Sheet and in the Administrative Data section of the EIR. The User Fee Re-Inspection package should be provided to the District Compliance Branch and contain:

  1. FSMA Re-Inspection Cover Sheet
  2. FACTS Assignment Sheet
  3. FSMA User Fee Re-Inspection Time Reporting sheet
  4. Completed EIR with attachments and exhibits

The District Compliance Branch, shall submit to the Office of Resource Management (ORM) at “ORA FSMA User Fee Billing”(ORAFSMAUserFeeBilling@fda.hhs.gov):

  1. FSMA Re-Inspection Cover Sheet
  2. FACTS assignment sheet
  3. FSMA User Fee Re-Inspection Time Reporting sheet

 5.4.12 - PESTICIDES

 5.4.12.1 - Pesticide Inspections

The objective of a Pesticide Inspection is to determine the likelihood of excessive residues of significant pesticides in or on products in consumer channels, and to develop sources of information for uncovering improper use of pesticide chemicals.

This requires directing coverage to two major areas:

  1. Pesticide practices in the production and processing of field crops.
  2. Application of pesticide chemicals in establishments storing and processing raw agricultural products.

Pesticide coverage must be provided during all food establishment inspections. Coverage of raw agricultural products will generally be on a growing-area basis.

Problem areas include:

  1. Improper use of pesticides around animals - gross misuse of sprays and dips in animal husbandry may result in pesticide residues in foods.
  2. Use of contaminated animal feeds - waste and spent materials from processing operations may contain heavy concentrations of pesticide residues, which were present in the original commodity. See Compliance Policy Guide 575.100.
  3. Past pesticide usage - past pesticide practices on growing fields. Past use of persistent pesticides may result in excessive residues in the current food crop. You may need to check on pesticide usage for several years prior to an incident to ensure you gather enough information. Some pesticides last for many years in the environment.

 5.4.12.2 - Current Practices

Cooperative Activities - important sources of information relative to evaluating the "Pesticide Environment" include:

  1. At the start of the growing season, spray schedules recommended for each crop by county agents, state experiment stations, large pesticide dealers, farmers cooperatives, et al should be obtained.
  2. Visits to agricultural advisors may provide information relative to heavy infestation of insect pests and fungal infections on specific crops in specific areas.
  3. Daily radio broadcasts in most agricultural areas may provide information on spray schedules, insect pests, harvesting and shipping locations, etc.
  4. Field employees of fruit and vegetable canning and freezing plants usually recommend spray schedules, pesticides, and harvesting schedules for products produced by contract growers.
  5. United States Weather Bureau Offices and their reports will provide data on weather conditions, which may effect insect growth and their development, size of fruit or leaf growth, and dissipation of pesticide chemicals.
  6. USDA Market News Service daily price quotations, and weekly quotations in trade magazines provide information regarding harvesting schedules since market prices are indicators of how quickly a crop will be harvested in a given area. Growers who have the opportunity to obtain high prices may harvest their crops without regard to recommended pre-harvest intervals.
  7. State Colleges of Agriculture seminars or short courses on food and vegetable production may alert you to significant departures from usual agricultural practices. Prior approval to attend such meetings should be secured from your supervisor.
  8. Pesticide suppliers and distributors may provide information on spray practices, schedules, and the name and address of growers, etc.

NOTE: The U.S. Department of Agriculture has a Pesticide Data Program (PDP), which provides data on pesticide use and residue detection. This program helps form the basis for conducting realistic dietary risk assessments and evaluating pesticide tolerances. Coordination of this program is multi-departmental, involving USDA, EPA and FDA, covered by a MOU (Federal Cooperative Agreements Manual). As a part of this program USDA collects data on agricultural chemical usage, and factors influencing chemical use, and collects pesticide residue data through cooperation with nine participating states. USDA provides this data to EPA, FDA and the public. Several USDA publications are listed below as reference material.

The contact point at USDA for pesticide residue matters is:
Martha Lamont, Director
Monitoring Program Office, Science Division
Agricultural Marketing Service, USDA
8609 Sudley Road, Suite 206
Manassas, VA 20110
703-330-2300

Reference materials - the following reference materials provide background and data necessary or helpful in evaluating current practices. This material should be available at the District office.

  1. Pesticide Chemicals - Regulations under the Federal Food, Drug and Cosmetic Act on tolerances for pesticides in food administered by the Environmental Protection Agency (EPA). (See 40 CFR 185)
  2. EPA's Pesticide Regulations - Tolerances for Raw Agriculture Products.(See 40 CFR 180)
  3. EPA's Rebuttable Presumption Against Registration (RPAR) List.
  4. Pesticide Index. - By William J. Wiswesser. A publication containing information on trade names, composition and uses of commercial pesticide formulations.
  5. The Daily Summary or Weekly Summary. News releases and reports from USDA.
  6. USDA's Weekly Summary Shipments-Unloads.
  7. Agricultural Economic Report No. 717 Pesticide and Fertilizer Use and Trends in U.S Agriculture (May 1995)
  8. Annual Pesticide Data Summary
  9. Reports from USDA's Crop Reporting Board.
  10. USDA's Pesticide Assessment Reports.

 5.4.12.3 - Growers

Preliminary investigation of growing areas at the start of the season will provide data necessary for district work planning including production schedules, types and acreage of crops, pesticides used and the names and addresses of growers and shippers.

Growing Dates - The significant growing dates relative to pesticide usage are as follows:

  1. Planting date,
  2. Date of full bloom, and
  3. Date of edible parts formation.

Harvest Dates - The dates of the anticipated harvest season will provide planning information relative to pre-harvest application and shipping.

Acreage - This will provide volume information for work planning.

 5.4.12.3.1 - PESTICIDE APPLICATION

Ascertain the actual pesticide application pattern for each crop. Look for objective evidence to document actual grower practice. Check the grower's supply of pesticide chemicals, look for used pesticide containers, visit his source of supply, etc. Check spraying and dusting practices. Establish if pesticide chemicals are used in such a manner that excessive residues might result.

The following information provides a basis for evaluating pesticide usage:

  1. Pesticide Chemical Applied - List the common name if there is no doubt as to the chemical identity of the pesticide. Include labeling indications and instructions.
  2. Method of Application - Describe the method of application i.e., ground rig, airplane, greenhouse aerosol, hand, etc.
  3. Formulation - Describe the formulation i.e., wettable powder, emulsifiable concentrate, dust, granules, aerosol, etc. Express as pounds of active ingredient per gallon or percent wettable powder.
  4. Number of Applications and Dates.
  5. Rate of Last Application - Calculate the amount of active ingredient per acre.
  6. Pre-Harvest Interval (PHI) - Calculate the number of days between the day of the last application of pesticide and the harvest date or anticipated harvest date. Compare to the PHI.
  7. Visible residue on grower's crop.
  8. Summary of Usage - Determine the USDA Summary Limitations and evaluate the responsible usage.

 5.4.12.3.2 - PESTICIDE MISUSE/DRIFT/SOIL CONTAMINATION

Pesticide residues, which exceed established tolerances, action levels, or "regulatory analytical limits" may be caused by pesticide misuse which can include:

  1. Excessive application of a chemical on a permitted crop.
  2. Failure to follow labeled time intervals between the last pesticide application and harvest.
  3. Use of a non-approved pesticide on a crop.
  4. Failure to wash a crop when pesticide labeling requires it (e.g., for certain EBDC's).

Other conditions, which may cause illegal residues, include spray drift and soil contamination.

Drift may be documented by determining which crops and pesticides have been grown/used in fields adjacent to those sampled. Determine direction of prevailing winds and wind condition on the day of spraying. Selective sampling will aid in determining if drift occurred. Compliance Samples collected to document pesticide drift should be Flagged and noted in block 16 of the CR as "Drift Sample - Maintain as Individual Subs".

Soil contamination by compounds, which are relatively stable in the environment, may cause systemic uptake of the compounds by growing crops. Follow-up investigations to violative samples may, in some limited cases, include soil samples as an attempt to determine the source of the contaminant. Do not routinely collect soil samples.

 5.4.12.4 - Packers and Shippers

Follow the same general procedure as in IOM 5.4.12.3. Observe and report the following:

  1. Treatment Before Shipping - This may include stripping of leaves, washing, vacuum cooling, application of post-harvest preservative chemicals, use of cartons with mold-inhibiting chemicals, waxes, colors, fumigation, etc.
  2. Identification of Growers' Lots - Determine procedure or methods used to maintain the identity of each grower's lot. Provide the code and key if any.
  3. Labeling - Quote labeling or brand names.
  4. Responsibility - Determine whether the packer or shipper knows what sprays have been used on the products shipped.

 5.4.12.5 - Pesticide Suppliers

Pesticide suppliers should be visited routinely during growing-area coverage. They may provide valuable information about pesticides being used on various crops in the growing area. Some suppliers may suggest spray schedules or advise growers about pesticide usage.

Determine what representations were made by the manufacturer of pesticide chemicals for which there is only a temporary tolerance or experimental permit. Get copies of any correspondence relating to sale and use of these products. Obtain names of growers to whom sales are made if such sale was not for use on acreage assigned under the experimental permit. Collect Official Samples of any crops treated with the pesticide.

 5.4.12.6 - Pesticide Applicators

Pesticide applicators may provide valuable information about pesticides being used on various crops in the growing area. Interview several pesticide applicators, particularly those using airborne equipment. Determine the pesticide chemicals, their formulation, and on what crops they are currently being applied. Determine who supplies the pesticides and how they are prepared to assure proper concentration. If state law requires the applicator to keep a record of each spray application, request permission to review such records. Determine what steps are taken to assure drift on adjoining crops does not result in violative residues. Where there is likelihood of drift, collect Selective Samples from adjoining fields.

 5.4.12.7 - Sample Collections

See IOM Sample Schedule Chart 3 - Pesticides.