Contents

SUBCHAPTER 530 - FOOD

530 - FOOD INSPECTIONS

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

530.01 - 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 517.
2. Become familiar with current programs relating to the particular food or industry involved and relevant DFI inspection guides. These are referenced in Chapter 10 of the IOM. 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 various parts of 21 CFR pertaining to foods, as appropriate:
   • 21 CFR Part 110 - GMP's on foods
   • 21 CFR Parts 108 & 113 - Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
   • 21 CFR Part 114 - Acidified Foods are of particular importance
   • 21 CFR Part 120 - HACCP Systems (covers Juice Processors)
   • 21 CFR Part 123 - Fish and Fishery Products
   • 21 CFR Part 129 - Processing and Bottling of Bottled Drinking Water
   • 21 CFR Part 130, et al - Food Standards
   • 21 CFR Part 1240 - Control of Communicable Disease
   • 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 533.

530.02 - Inspectional Authority

See IOM 701 for broader information on this topic.

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

1. Written Demand for Records - 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.

To obtain the records:

(a) 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." (b) Sign the form. (c) Issue the original to the same person to whom the FDA 482, "Notice of Inspection", was issued. (d) Submit the carbon copy with your EIR.

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 effect 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.

530.03 - 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 545).

530.04 - Food and Cosmetics Defense Inspectional Activities

Food and cosmetics security inspectional activities should be conducted as an “Add-On” to 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.

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:

• Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance
• Importers and Filers: Food Security Preventive Measures Guidance
• Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance
• Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance
• 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/oc/factsheets/foodsecurity.html. 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.

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 620 and 632. For imported food and cosmetics, a reconciliation examination should be conducted: (1) as an “Add-On” to all routine import field exams; AND, (2) in instances where review of entry information raises suspicion (resulting in a targeted reconciliation exam).
A targeted 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 (e.g., tuna from Saudi Arabia).
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 below for domestic and import reconciliation exams.

Reconciliation Examination Guidance

PART A
Reconciliation examinations are performed to ensure that:

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

• the actual goods in a lot are the same as those that are declared in the shipping documents
• there is consistency in the manufacturer declared on the product labeling, bulk product packaging, and shipping documents
• for infant formula, the manufacturer has notified FDA consistent with Import Alert #40-01; and
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 of this guidance while conducting a detailed reconciliation exam.
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:

• product identity on the package that does not match the identity declared on the shipping documents
• mixed product sizes within a carton or within the lot;
• product sizes that do not match the sizes declared on the shipping documents
• differences in product configuration or package type (e.g. plastic containers mixed with glass jars or aluminum or steel cans)
• easily apparent variations in weight
• product labels that display crude, unprofessional, or inconsistent styles of print, color or use of language
• unusual placement of labels (e.g. off-center)
• 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
• differences between the actual can codes in the lot and those listed on the shipping documents
• the existence of a tamper-evident notice on the labeling when the packaging does not contain a tamper-evident feature
• product that is beyond its expiration date
• inconsistencies in expiration dates within a lot

• differences between the product and that which is declared on the label


• color differences in the product between containers of the same lot


• 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)
  
• · readily detectable abnormal odors (e.g. strong decomposition, bitter almond, petroleum odor, garlic, chlorine, sulfur). Note: specific sensory examination is not expected.

Special Safety Precautions

See IOM Subchapters 140 Safety, sections including 141.01 thru 141.04, and Section 143 on sampling hazards.
When performing an establishment inspection or reconciliation examination follow these instructions:

• 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.
• 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.
  

530.05 - 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 an interim final rule on October 10, 2003 (68 FR 58894) to implement this requirement. The regulations will be codified at 21 CFR 1 Subpart H - 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 facility’s name, address, telephone number and, if available their fax number and e-mail address. If applicable, they must register the same information for their parent companies. They must also register emergency contact information, trade names, general product categories, and, if a foreign facility, information about their U.S. Agent. They can also supply optional information. The registrant must certify the truthfulness and accuracy of the submitted information.

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.

The Bioterrorism Act makes failure to register a prohibited act but, unlike registration requirements for drugs and devices, does not make the product violative. The person submitting a registration is required to certify that the registration information is true and accurate, and that the submitter is authorized to register on behalf of the facility.

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

Facilities Exempted from Registration

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

(a) 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;

(b) 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:

(i) 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
(ii) 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.

(c) Retail food establishments whose sales to consumers exceed their sales to non-consumers (businesses are considered non-consumers);

(d) Restaurants that prepare and serve food directly to consumers for immediate consumption;

(e) Nonprofit food establishments in which food is prepared for, or served directly to, the consumer;

(f) 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;

(g) 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.

Agency Website Link :
More specific information regarding the Bioterrorism Act and food registration may be obtained at the following website: http://www.cfsan.fda.gov/~dms/fsbtact.html

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.cfsan.fda.gov/~dms/fsbtact.html

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.cfsan.fda.gov/~furls/helpol.html) 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. Observations about failure to register are NOT to be placed on the FDA 483.

531 - PERSONNEL

Management - Follow the guidance described in IOM 525 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.

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 536.02.

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 593.03.

532 - PLANTS AND GROUNDS

Environment - 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.

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.

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.

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.

533 - RAW MATERIALS

Source - 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.

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.

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.

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.

534 - 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.

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.

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.

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 427.06 for procedure on taking In-line Sample Subs.

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.

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.

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

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.

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.

535 - 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.).

535.01 - 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.

535.02 - 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.

535.03 - Food Additives

Refer to the food additives program in the CPGM (Chapter 9) for instructions on conducting establishment inspections of firms manufacturing food additive chemicals. Information is also available in DFI's "Guide to the Inspection of Manufacturers of Miscellaneous Food Products - Volume 2.

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) 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. See IOM Appendix A.

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 530-B.
5. Determine probable level of restricted ingredients by observing the weight of each ingredient actually put into the batch.

535.04 - Color Additives

Evaluate the status of all colors observed during each food establishment inspection by using the Color Additives Status List. The list provides the current status and use limitations of most colors likely to be found in food, drug, device, or cosmetic establishments. See IOM Appendix A.

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, e.g., use in non-food products.

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.

535.05 - 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.

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.

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.

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.

535.06 - 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.

Quantity of Contents - If slack fill is suspected, weigh a representative number of finished packages. See IOM 428 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.

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. Obtain 3 copies of labels and labeling believed to be violative.

Nutritional Labeling - See document "Guide to Nutritional Labeling and Education Act (NLEA) Requirements" for guidance.