Inspections, Compliance, Enforcement, and Criminal Investigations
Interstate Carriers and Support Facilities (4/95)
GUIDE TO INSPECTIONS OF INTERSTATE CARRIERS AND SUPPORT FACILITIES
Note: This document is reference material for investigators and other FDA personnel. The document does not bind FDA, and does not confer any rights, privileges, benefits, or immunities for or on any person(s).
TABLE OF CONTENTS
A. Administrative and Regulatory
B. Industry Education
C. Interaction with Government Agencies
Section 7 - Construction of Equipment,
A. Equipment Review
B. Conveyance Construction
C. Frequency of Inspection
D. Certification of Conveyance Construction
E. Support Facility Construction
F. Construction Compliance Levels
A. Frequency of Inspection
B. Inspection Techniques - General
C. Inspection Techniques - Specific
A. Frequency of Inspection
B. Support Facilities Compliance Levels
C. Inspectional Procedures
D. Catering Point/Commissary
E. Watering Points
F. Service Areas
G. Wastes Discharged from Railroad Conveyances
A. Federal State Cooperation
B. Official Classification Lists
C. Foodborne Illness Investigation
D. Technical Assistance Meetings
ATTACHMENTS 1. Guideline for Evaluating Aircraft Drinking Water Servicing Vehicle Construction 2. Guideline for Evaluating Aircraft Lavatory/Toilet Servicing Vehicle Construction 3. Guidelines for Sanitary Construction of Aircraft Galleys and Galley Components 4. Access to electronic information systems 5-12. See Section 4 - FDA Forms
Attachnebt 10 6. FDA-2465 - Inspection Summary - Aircraft Sanitation, Bus Sanitation, Railroad Car Sanitation page 38
Attachment 12 8. FDA-2528 - Inspection Summary - Airline Servicing Area or Watering Point Sanitation page 40
Attachment 13 9. FDA-2529 - Inspection Summary - Railroad Watering Point or Servicing Area Sanitation page 41 (Back) page 42
This guide is meant as interim guidance for the conduct of Interstate Travel Sanitation (ITS) program activities, and is an update of information published in the 1992 edition of the IOM.
One major change in ITS procedures is the way Certificates of Construction are issued for all conveyances if regions or districts are unable to provide individual on-site inspection of conveyance construction because of competing priorities or lack of resources (Note: the term region/district is used throughout this document because some in some regions ITS inspections are conducted by regional personnel). In the past FDA has requested submission of pertinent description, serial or identification number and a statement that buses (only) were assembled according to plans and specifications previously approved by FDA. These instructions were outlined in FMD #58, which will be cancelled. The current instructions, which are similar, but cover all conveyances, are contained in this guide under the section headed "Certification of Conveyance Construction".
This document also contains guidance on Center for Food Safety and Applied Nutrition's (CFSAN) policy on managing the temperature of potentially hazardous food, and justification for identifying temperature as an objectionable condition.
In addition, the information contained in FMD #67 "ITS Program: Reporting Catering Point and Facility Inspection Classification to Carrier companies" will be incorporated into the next printing of Compliance Program 7318.029-Retail Food Protection- Interstate Travel Sanitation, and at that time FMD #67 will be cancelled.
The classification scheme for ITS firms has been modified to correspond with the current Field Management Directive, No. 86 - Establishment Inspection Report Conclusions and Decisions.
Guidelines for evaluating aircraft drinking water servicing and lavatory/toilet vehicle construction taken from the 1982 reprint of the Handbook on Sanitation of Airlines have been added to this guide and are attached as Attachment 1 and 2.
CFSAN is developing a plan for FDA use of the "1993 Food Code". Until that plan is announced FDA personnel will continue to perform ITS food service inspections using the 1976 Food Service Sanitation Manual.
The legal basis for the Interstate Travel Sanitation (ITS) Program is contained in both the Public Health Service (PHS) Act and the Food, Drug, and Cosmetic (FD&C) Act.
Public Health Service Act - Section 361(a) (42 USC 264) states in part that "The ... [Commissioner of Food and Drugs as delegated under 21 CFR 5.10(a)(4)], with the approval of the Secretary is authorized to make and enforce such regulations as in his judgement are necessary to prevent the introduction, transmission, or spread of communicable diseases from... one State or possession into any other State or possession. For purposes of carrying out and enforcing such regulations, the ... [Commissioner] may provide for such inspection, fumigation, disinfection, sanitation, pest extermination... and other measures, as in his judgement, may be necessary."
Section 311 of the PHS Act (42 USC 243) authorizes Federal-State cooperation.
Penalties for violations of 21 CFR 1240 and 1250 are included in Section 368 (42 USC 271) and specify a fine, imprisonment or both.
Food, Drug, and Cosmetic Act - The FD&C Act authorizes regulatory control over storage, processing, transporting, etc., of food, drugs, and cosmetics, including food and color additives. Penalties or sanctions for violations in the ITS Program area may be considered under certain conditions; e.g., when administrative or regulatory sanction under the PHS Act is ineffective, injunctions or seizures are considered necessary; or where there are violations under the Food Additive Amendments.
Criminal Fine Enforcement Act of 1984 - (PL 98-596) amends 18 USC to provide new fines for federal law violations. The applicability to FDA includes the PHS and FD&C Acts and others containing provisions enforced by FDA.
Regulations - The primary regulations applicable to this program area are located in 21 CFR 1240 - Control of Communicable Diseases, and 21 CFR 1250 - Interstate Conveyance Sanitation.
Handbooks, inspectional reporting forms, certificates, and other documents relating to specific types of conveyances (aircraft, bus, passenger railroad car, or vessel) were developed to provide general guidance for the construction and operation of conveyances and conveyance support facilities. Although these documents do not have the legal force of regulations, they were written to provide guidance for compliance with 21 CFR 1240 and 1250.
The following references are used in the ITS Program area.
- 1. Compliance Program Guidance Manual (CPGM).
- 2. Public Health Service Act, PL 78-410, 42 USC 202 et seq.
- 3. Food Drug and Cosmetic Act.
- 4. Code of Federal Regulations, Title 21, Parts 1240 and 1250, "Control of Communicable Diseases and Interstate Conveyance Sanitation Regulations."
- 5. Handbook on Sanitation of Airlines, Publication No. 308, (1982 Reprint) which includes 1) Sanitary Construction of Aircraft Galleys and Galley Components, September, 1982 Reprint; 2) Evaluating Aircraft Lavatory Servicing Vehicle Construction, 1982 Reprint, and 3) Evaluating Aircraft Drinking Water Servicing Vehicle Construction, 1982 Reprint.
- 6. Handbook on Sanitation of Buses, Publication No. 1454, 1966.
- 7. Handbook on Sanitation of Railroad Servicing Areas, Publication No. 66, 1963.
- 8. Handbook on Sanitation of Railroad Passenger Cars, Publication No. 95, 1964.
- 9. Handbook on Sanitation of Vessel Watering Points, Publication No. 274, (1963).
- 10. Handbook on Sanitation of Vessel Construction, Publication No. 393, (1965).
- 11. Handbook on Sanitation of Vessels in Operation, Publication No. 68, (1963 Reprint).
- 12. Food Service Sanitation Manual, 1976, DHHS Publication No. (FDA) 78-2081.
- 13. The Vending of Food and Beverages, 1978, DHEW Publication No. (FDA) 78-2091.
- 14. EPA, Drinking Water Regulations, 40 CFR 141, 142, and 143.
- 15. EPA, Cross-Connection Control Manual, revised 1989.
- 16. FDA Compliance Policy Guides, Memorandums of Understanding with EPA and Canadian Government for ITS.
- 17. NSF Standards International, Evaluations, Listings and Other Materials, Box 130140, Ann Arbor, MI 48113-0140. TEL (313) 769-8010, FAX (313) 769-0109. Note: NFS information is now available via modem. Instructions on how to access the system is included as Attachment 4.
- 18. National Automatic Merchandising Association (NAMA), 20 North Wacker Drive, Suite 3500, Chicago, IL. 60606-3102, Tel (312) 346-0370, FAX (312) 704-4140 (vending machine standards and listings only).
- 19. Baking Industry Sanitation Standards Committee (BISSC), 40 North Michigan Ave., Chicago, Il. 60611, Tel (312) 644-6610, FAX (312) 321-6869.
Note: publications and/or related information is available from the Industry Activities staff (HFS -565), CFSAN, (202) 205-5251. (At this time, publications 6-12 are out of print and copies are not available. These documents are undergoing extensive revision).
- 1. FDA-2371 - Certificate of Sanitary Construction (Attachment 5 )
- 2. FDA-2371A - Certificate of Sanitary Construction (Attachment 6)
- 3. FDA-2372 - Certificate of Sanitation (Attachment 7)
- 4. FDA-2420 - Food Service Establishment Inspection Report (Attachment 8) (Back)
- 5. FDA-2432 - Inspection Summary - Vessel Sanitation (Attachment 9) (Back)
- 6. FDA-2465 - Inspection Summary - Aircraft Sanitation, Bus Sanitation, Railroad Car Sanitation (Attachment 10)
- 7. FDA-2521 - Inspection Summary - Vessel Watering Point Sanitation (Attachment 11)
- 8. FDA-2528 - Inspection Summary - Airline Servicing Area or Watering Point Sanitation (Attachment 12)
- 9. FDA-2529 - Inspection Summary - Railroad Watering Point or Servicing Area Sanitation (Attachment 13) (Back)
- 10. FDA-2589 - Inspection Summary - Bus Service Area Sanitation (Attachment 14)
- 11. FDA-2591 - Inspection Summary - Equipment Evaluation (Attachment 15) (Back)
Items 1-3 above are available from HFC-132, (301) 443-3340. The others are available from the Consolidated Forms and Publication Distribution Center and should be obtained through the Investigation Branch forms' coordinator.
For technical assistance, contact the Assistant Director for Interstate Travel Sanitation, Retail Food Protection Branch (RFPB) HFS-627, (202) 205-8140, FAX (202) 205-5560.
The objective of the program is to ensure that personnel, facilities and equipment are adequate, and managed, to prevent foodborne illness, and the introduction or spread of communicable disease via common carriers operating in interstate commerce. This objective encompasses: management knowledge; employee health and practices; general sanitary conditions; the control of microbiological hazards and filth in food and water aboard conveyances, and in the support facilities and operations providing services to conveyances.
Program inspectional coverage must include all interstate traffic operations as defined in 21 CFR 1240.3(h) and 1250.3(h). The term "state" is defined in 21 CFR 1240.3(n) and 1250.3(k). This coverage should include conveyances and support facilities of/for companies which honor bill of lading or tickets issued on an interstate basis whether or not the conveyance (carrier) operates interstate. Foreign quarantine regulatory responsibilities are found in 42 CFR Part 71. Part 42 CFR section 71.45 'Food, Potable Water and Waste: US Seaports and Airports' may enable FDA to inspect facilities and vessels engaged in "cruises to nowhere" if the operations are not inspected by CDC.
A. Administrative And Regulatory Activities
- 1. Evaluate plans and specifications, and make on-site inspections of the construction of conveyances, equipment and support facilities.
- 2. Enforce communicable disease interstate conveyance sanitation regulations through surveillance of sanitation practices of interstate conveyances and their support facilities to prevent the presence of disease and filth vectors in food, water or other articles.
- 3. Investigate reports of suspected disease reports involving interstate carriers; determine the causes of confirmed illnesses and initiate corrective actions.
- 4. Initiate administrative/regulatory actions as necessary to ensure compliance.
B. Industry Education
- 1. Distribute conveyance and support facility handbooks and related materials to aid industry in achieving and maintaining compliance.
- 2. Establish and maintain liaison with carriers, servicing organizations, and trade groups to promote training and effective quality control programs.
C. Interaction with Government Agencies and Others
Adhere to policy, and commitments established under MOUs. Establish and maintain relations and cooperative efforts with state and local health departments, and with federal agencies such as USDA, ICC, EPA, CDC, and DOT (USCG, MarAD, FAA, & FRA) within areas of related operations. Establish, maintain, or continue cooperative or other efforts with Health Canada, PAHO, WHO and others. Coordinate these efforts with CFSAN/ITS and ORO. See Section 10 of this guide for information on Federal-State Cooperation.
A. Equipment Review
Domestic and foreign equipment of public health and sanitation significance that is used on ITS conveyances or in support facilities must meet the requirements of 21 CFR 1240 & 1250.
Equipment that has been found acceptable or meets the requirements for sanitary design/application of a nationally recognized association, such as NSF International, American Society of Sanitary Engineering, Baking Industry Sanitation Standards Committee, National Automatic Merchandising Association, etc., need not be reviewed by FDA for sanitary design; however, the specific use, installation, and other critical factors must be considered. Any observed defects should be reported to the standards organization. If in doubt contact Retail Food Protection Branch (HFS-627).
Review plans and specifications and make equipment construction inspections, to determine the adequacy of food, water, waste handling and related equipment; and to ensure that new equipment is fabricated using safe material, is free from defects in design and construction, requires a minimum of maintenance and is designed to be easily cleaned. Equipment that has been accepted in the past by FDA does not automatically qualify it for continued approval. An up-to-date evaluation and approval may be necessary.
Review plans and equipment during design or prototype work-up rather than after construction has begun when changes are difficult. Maintain routine contact and dialogue with manufacturers or conveyance companies so FDA input can be incorporated into equipment design and construction at a very early stage. Use Guidelines for Sanitary Construction of Aircraft Galleys and Galley Components (Attachment # 3) as a general guide when inspecting railroad and bus galley equipment. When inspecting vessel galleys, which have different galley requirements, use the Handbook on Sanitation of Vessel Construction. Also consider:
1. Operating condition and previous compliance experience.
2. Design of equipment in relation to its use.
3. Compatibility with operating environment.
4. Final installation.
5. Capacity of refrigeration and hot holding equipment.
Whenever possible, conduct inspections while the equipment is actually being constructed. Base inspectional reports on an examination of a production line model intended for sale, and properly identified by markings or nameplate showing the model or serial number.
Perform the preliminary review of new equipment to ensure the proposed items are free from sanitary defects in design and construction, fabricated from safe material, and adequate for anticipated operations. Ensure that equipment recommended for acceptance is supported by sufficient evidence for decision making.
Provide a detailed description of the equipment, how it functions, and on which type of conveyance it is used. For critical equipment such as refrigerators, ovens, hot holding or "insulated" and other potentially hazardous food holders/transporter, etc., obtain documentation to show efficacy for temperature control and maintenance, and other critical factors. Identify all materials used in product contact surfaces, e.g., stainless steel, nickel alloy, and paint, giving particular attention to the possible use of toxic ingredients such as lithium, cadmium or lead, and the application of plastics and silicones. Include food additive status (direct & indirect) of all food contact surfaces.
Include material such as manufacturers' brochures, photographs, engineering drawings and specifications and a detailed description of sanitation defects, where applicable, or a statement that no sanitation defects were noted. Review manufacturer's literature and other materials for installation, operation, maintenance, and promotion, and include with the FDA-2591. Include any statements of voluntary action taken by management.
Upon completion of an equipment examination, issue an FDA-483 listing any deficiencies in detail.
The region/district should issue a post-inspection "Letter of Compliance" for inspectional findings resulting in District Decision inspection classifications of NAI or VAI. When the District Decision inspection classification is OAI follow standard procedures for compliance measures.
B. Conveyance Construction
21 CFR 1250.41, Subpart C, requires that construction plans be submitted for "land and air conveyances", including tugboats and cabooses. Current FDA resource constraints generally limit regular operations to construction and reconstruction of passenger aircraft, vessels, railroad cars, and buses. Activity for buses should be initiated only for special reasons such as new or modified designs or operational problems. When conducting construction operations follow the regulations as well as handbooks or other guidelines. In this section, the term "construction" will include "reconstruction". Since foreign built conveyances and components used in interstate commerce must also meet these requirements, each region/district must formulate a strategy for achieving compliance of imported items.
In order to ensure adequate coverage, conduct:
1. Plan review (including specifications).
2. Progress inspections.
3. Final inspection of completed conveyance.
Review plans and inspect conveyance construction to determine the sanitary acceptability of food, water, and waste handling systems. The following districts possess conveyance construction operations expertise and the ITS Specialist may be contacted if questions arise within their area of expertise:
Aircraft Seattle Bus Minneapolis Railroad Baltimore Vessels New Orleans
Maintain contact with builders and carriers to ensure that specifications and construction plans are submitted early during design phases to evaluate conformance and analyze problem areas. The early submission of specifications and plans is essential, as it is easier to correct defects on paper than on existing structures.
Except for problem areas or items which cannot be resolved locally, plans for aircraft, vessels, buses, and railroad cars are reviewed and approved by builder region/district personnel. However, coordination with other regions/districts may be necessary, e.g. activity involving railroad food service cars should be coordinated with the operators's home region/district so that all appropriate factors will be considered. Food service equipment for buses and railcars should be reviewed for compliance with applicable sections of the current Guidelines for Sanitary Construction of Aircraft Galleys and Galley Components (Attachment # 3) and Food Service Sanitation Manual (1976), as well as Handbook requirements. When covering construction of railcars be sure to cover rat-proofing. When inspecting vessel galleys, which have different galley requirements than other conveyances, use the Handbook on Sanitation of Vessel Construction. CFSAN/ITS (HFS-627) may provide limited assistance to the field in reviewing and analyzing conveyance plans and specifications, and guidance on waste discharge requirements.
Encourage vessel builders, naval architects, owner's agents and others to submit vessel plans as early as possible. Initially, it must be determined that the vessel will be subject to FDA jurisdiction upon operation. See Section 8, Part C.3 for guidance on vessels covered by CDC. Two copies of the plan schedule are needed at the beginning of plan review activities and should be forwarded by industry to the reviewing FDA field office. One plan schedule copy will be marked by FDA to indicate which plans are to be submitted for review and a marked copy will be returned to the industry.
Subsequently one set of the vessel plans and specifications must be submitted to FDA for review. An extra set will be needed when the construction will take place elsewhere (this extra set along with correspondence will be sent to the FDA region/ district construction site).
Only ITS specialists designated by CFSAN\ORO Headquarters are to review vessel construction plans and specifications. The designated districts/ITS specialists and their areas covered are:
BOSTON - (States) Walt McPartlin Connecticut Minnesota Illinois New Hampshire Indiana New York Maine Rhode Island Massachusetts Vermont Michigan Wisconsin BALTIMORE - (States) Bruce Kummer District of Columbia Ohio Delaware Pennsylvania Maryland Virginia New Jersey West Virginia NEW ORLEANS - (States) Caroline White Alabama Mississippi Arkansas Missouri Florida Nebraska Georgia New Mexico Iowa North Carolina Kansas Oklahoma Kentucky South Carolina Louisiana Tennessee Texas SAN FRANCISCO - (States) Randy Zielinski Hawaii Nevada California SEATTLE - (States) Dave Hajduk Alaska Oregon Idaho Washington Southern Cal Arizona
Inspecting district personnel, based on the location of vessel construction sites, are responsible for initial and follow-up inspections and the issuance of Certificates of Sanitary Construction. See Section 7, Part D, Certification of Conveyance Construction.
EPA has primary responsibility for drinking water tank liners and some other water contact and/or treatment materials per MOU dated 10/1/80 (see CPG 7155b.09). However, EPA has delegated responsibility for this review to National Sanitary Foundation International (NSF) and Underwriters Laboratory, under NSF/ANSI Standards #60-Drinking Water Treatment-Health Affects, dated 10/7/88, and #61 Drinking Water System Components-Health Affects dated 5\28\92. EPA also has jurisdiction over the public water system supplying interstate carrier conveyances and drinking water on these conveyances. See MOU dated September 22, 1978 between FDA & EPA (CPG 7155b.08) which outlines each agencies responsibilities under this agreement.
C. Frequency of Inspection
Aircraft - Construction inspections of aircraft are concentrated on the prototype or first production aircraft. Inspect the aircraft as necessary during construction to ensure compliance. The initial inspections include the drinking water system and sewage system. Inspect these after initial installation so the complete system may be evaluated. Make the next inspections as the galleys are being installed so the galleys and installation may receive a final evaluation. Include other areas of sanitary significance of the aircraft in these inspections. Make subsequent inspections of all similar production units only as necessary to ensure continued adherence to good sanitary practices.
Railroad Car - Construction inspections of railroad cars are concentrated on the prototype (if one is developed) or the first production unit. Inspect the dining car and other food service cars approximately four times during construction unless further inspections are necessary to ensure compliance. The first two inspections cover the drinking water system sewage system, and rat-proofing, and are usually completed when the piping of these systems can be observed. The second two inspections cover the food preparation (galley) area as well as the remainder of the car. Make subsequent inspections of all similar production units only as necessary to ensure continued adherence to good sanitary practice. Inspect non-food service cars as necessary to ensure adequacy of water and waste systems and their installation, and rat-proofing.
Vessel - Generally inspect vessels at four different stages of construction to determine if construction compliance levels are met. Try to consolidate inspections. Inspections should cover the following items:
Inspection 1: Make this inspection at or about the time of launching to determine proper location and installation of drinking water tanks and any drinking water lines that have been installed. Inspect the interior of the drinking water tanks before the tanks are filled and closed.
Inspection 2: Make this inspection when the refrigeration spaces are installed to allow visual examination of rat-proofing. During this inspection, check the drinking water supply piping and distribution piping water treatment units and the drain and sewage piping.
Inspection 3: Make this inspection while the galley is being installed. During this inspection, check rat-proofing of the galley, food stores, dining and living quarters, and related areas. Drinking water and drainage systems may also be inspected.
Inspection 4: Make this final inspection when the ship is completed and ready for delivery. During this inspection, check the food service areas and the remainder of the ship for compliance.
Buses - Construction inspection of buses is concentrated on the prototype bus. Inspect the restroom and galleys and related water and waste systems.
D. Certification of Conveyance Construction
Subsequent to specification, plan, and construction investigations, Certificates of Sanitary Construction (CSC) should be issued for conveyances found to comply with FDA requirements. Refer to 21 CFR 5.36 and 1240.20 regarding issuance and posting on the conveyance (buses without galleys are currently exempt). Certificates come in two sizes (reference 6attachment 5 and 6). Industry generally specifies the size certificate and recipients must laminate or provide other protection for the certificates during use. Certificates may be re-issued as they deteriorate or as ownership changes. Qualifying statements may be judiciously added to CSCs for purposes such as limitations on food service operations, expiration dates for service/ operations, etc. Other information which should be placed "Over" (on the back) on the CSCs includes identity of galley models and manufacturer, etc. Certificates can be obtained from Investigations Branch (HFC-132).
If a region/district determines they cannot provide individual on-site inspection of conveyance construction because of competing priorities or lack or resources, the following procedure must be used for the issuance of 'Certificates of Sanitary Construction' for all conveyances. This procedure can only be applied after the blue prints, components and construction practices have been reviewed and approved by FDA.
When certification is requested, the firm will provide the region/district a letter or request which will contain:
1. Pertinent description of each conveyance or rail car (information required for completion of the certificate).
2. Serial or identification number for each conveyance or railcar.
3. A statement that the conveyance or car was built or assembled according to plans and specifications previously approved by FDA.
If these procedures are followed FDA will have a written agreement from the assembly firm. The firms can assume an FDA representative may follow up from time to time by inspecting the conveyances or cars before release of the certificates.
In no case can signed or blank certificates be released since they may be diverted for use on some other conveyance. This procedure in no way affects the routine coverage of the operation or servicing of these conveyances.
The CFSAN/ITS may be contacted for guidance on certification issues. Guidelines for FDA certification are as follows:
Aircraft - Issue a CSC for each aircraft meeting Food and Drug Administration standards. The CSC issuing region/district is responsible for forwarding copies of correspondence transmitting CSCs to the home office district of the aircraft manufacturing company. Since the galley is considered an integral part of the aircraft, certificates are not to be issued until after the galley is installed. If the galleys are built in another region/district, the galley builder region\district generally performs the necessary construction inspection and if acceptable, transmits the post inspection "Letter of Compliance" with a copy going to the appropriate region/district(s). Certificates will then be issued by the region/district in which the galleys are installed. In those cases, the aircraft builder region/district is responsible for forwarding a statement about aircraft compliance to the region/district in which the galleys are to be installed.
Railroad Cars and Buses - Issue a CSC for each rail car and bus meeting FDA requirements. When more than one region/district is involved in the construction of the conveyance and components, coordination between the regions/districts is necessary.
Vessels - Issue a CSC when it has been determined through inspection that a vessel meets FDA requirements. When a vessel in interstate traffic is completely rat-proofed (although this is not required, except in galley, crew, and related spaces), add the following or similar statement to the CSC: "This entire vessel was constructed in accordance with the Food and Drug Administration's rat-proof requirements." When more than one region/district is involved in the construction of the conveyance and components, coordination between the regions/districts is necessary.
E. Support Facility Construction
Facilities to be inspected include catering points, commissaries, watering points, waste service areas and related equipment/systems manufacturing firms.
Plans and specifications for new or major reconstruction of an establishment must be submitted to the region\district to ensure that all provisions of the Food Additive Amendments, and 21 CFR 1240 and 1250 are met when construction is completed. State, local and other government agencies are responsible for the enforcement of their health, plumbing, building or other codes applicable to support facilities. When possible, plan review and on-site inspections should be coordinated with other officials responsible for public building construction. This review should determine if the water and sewage services are adequate for the planned operation. For a watering point, the water supply/quality must meet EPA's requirements for those serving conveyances.
Support facility plans are reviewed and the facility approved at the FDA region/district level. CFSAN/Retail Food Protection Branch (HFS-627) may be contacted to assist in the resolution of controversial or questionable plans or for related equipment reviews. Support facilities under construction may require three or more inspections, depending on the complexity of the construction; construction of related equipment generally only requires one inspection.
Regions/districts must initially approve a support facility before an interstate carrier company can use the products or services of the facility.
Annual contact should be maintained with the management of support facility firms to ensure construction plans and specifications are submitted early during design phases for an FDA evaluation and analysis for problem areas. Remember, early submission of plans is essential because it is easier and less expensive to correct defects on paper than on completed structures. Home regions/districts should encourage the development and/or adoption of standardized plans and specifications for nationwide application; such information is to be disseminated to other regions/districts and CFSAN/ ITS.
FDA field personnel also review and evaluate equipment for compliance with 21CFR 1240-1250 when it is used in conveyance support facilities. The field issues a post inspection "Letter of Compliance" for equipment which is in compliance with FDA requirements. The general equipment review procedures contained under the section "Construction of Equipment, are to be followed.
F. Construction Compliance Levels
Instructions on classification of EIR's are contained in Compliance Program 7318.029, in the Data Codes Manual and Field Management Directive 86.
The conveyances covered in this program include aircraft, buses, railroad food service and passenger cars, and vessels. Inspections are made to determine compliance primarily with the PHS Act as well as the FD&C Act. Inspections cover personnel, food, food preparation and storage, equipment and facilities including lavatories, toilets, swimming pools (on vessels), water, plumbing and waste systems, and procedures designed to minimize or eliminate disease outbreaks. Information on significant operating deficiencies that may relate to construction (whether of a domestic or foreign origin) of equipment or conveyances should be coordinated with other regions/districts as necessary.
Before inspecting conveyances, contact the proper authorities (Ramp Supervisor, Terminal Manager, Conductor, Chief on Board Services, Chief Stewardess etc.) prior to boarding. Conduct all inspections so as to minimize interference with both on board operations and support facility personnel and operations.
Drinking water quality responsibility aboard conveyances is shared between FDA (culinary water and drinking water delivery) and EPA (drinking water quality). See MOU dated September 22, 1978 (CPG 7155b.08).
A. Frequency of Inspection
Inspections of conveyances in operation should be based on the overall compliance conditions for the type of conveyance. The entire range of conveyance types and models should be inspected so that problems can be identified and addressed by more frequent inspection and other means. Passenger vessels and railroad dining cars would normally have a higher inspection priority than other operating conveyances. Passenger vessels should be inspected semi-annually and coordinated between operating regions/districts. A representative number of dining cars should be inspected annually.
B. Inspection Techniques, General
Inspect conveyances at a time and under conditions such that the complete food, water and wastes systems can be inspected as thoroughly as possible. Conditions/operations either should be or should approach actual in-use conditions. Issue one FDA-482 for each conveyance inspected except where one FDA-482 will suffice to cover a number of conveyances operated by one carrier and inspected at one location (station, terminal, etc).
Use appropriate ITS forms (see Attachments 9 (9 Back) and 10) and 'Handbooks' to assist in inspection of operating conveyances. In addition, the FDA-2420 Food Service Establishment Report (Attachment 8) (8 Back) is to be used for inspecting conveyances with food preparation areas, i.e., railroad dining cars & vessels. Since the basis for justifying any administrative sanctions or regulatory action against on-board conveyance food service facilities is the presence of, or potential for public health hazards or filth problems, the conditions on the conveyance must clearly demonstrate a violation of the PHS Act or the FD&C Act and must be fully documented.
While conducting enroute inspections, follow food to its final disposition such as offering for service to passengers. If a potentially hazardous condition clearly exists, explain the condition to the most responsible person on-board and discuss their intended actions for immediate voluntary compliance such as not using the food item(s) in question or modifying the food service satisfactorily.
Observe, describe, and document the following areas or items when conducting conveyance inspections, as applicable:
- 1. Food that appears to be adulterated or otherwise not wholesome due to storage at improper temperatures, storage that may cause filth contamination, or handling that may contaminate the products.
- 2. Food products that are not from an approved source or are not properly identified.
- 3. Procedures and processes used to store, prepare, hold, and serve food - document objectionable practices such as improper storage of potentially hazardous foods, improper thawing of frozen food products, improper cooking temperatures, and inadequate washing of uncooked fruits and vegetables. Check for improper storage of food; for example, on the floor, near toxic and poisonous materials, or wet storage of packaged food. Try to show the possible effect of the condition on the finished product.
- 4. Determine if there are adequate facilities to maintain proper product temperature. Cover conditions of refrigeration equipment, cold storage units, hot storage units, and warming ovens, and that thermometers are available and used. Record temperatures of the storage area where potentially hazardous food is stored.
- 5. In regards to the holding of potentially hazardous food at improper temperatures - The requirement of the Food Service Code is that potentially hazardous food shall be maintained above 1400F or below 450F except during necessary periods of preparation, cooking or cooling. CFSAN's policy is that the period of time that a food may be out of the safe temperature zone shall not exceed 4 hrs. If you are unable to observe the entire preparation/cooking/cooling period, a judgement based on actual observations along with employee interviews, can justify findings of noncompliance. The FDA-483 and EIR should clearly show the basis for determining that the period food was in the unsafe temperature zone will, or did exceed the 4 hour limit.
- 6. Cleanliness of tableware, utensils, and all other food contact surfaces.
- 7. Cleaning, sanitization and storage of equipment and utensils. Record wash and rinse water temperatures and information on cleaning and sanitizing agents. Whenever equipment is changed as a part of servicing, look closely at the normally inaccessible areas. Pay close attention to procedures used by non-conveyance service personnel for clean-up. Note: the presence of a cleaning product does not necessarily mean it was used.
- 8. Equipment used for food operations that appears to be malfunctioning or has been improperly altered, or that is used for other than the originally designed and approved purpose.
- 9. Insanitary employee practices.
- 10. Garbage and rubbish disposal processes. Include such items as adequacy of containers, location, and availability of lids for these containers.
- 11. Presence of vermin (rodents, flies, roaches, etc.) and their proximity to food products and food contact surfaces. If the vermin are observed on a food contact surface, list affected food and note if this food is subsequently offered to passengers during enroute service.
- 12. Conditions in surrounding areas such as general housekeeping, lighting, and cleanliness of the floors, walls, and ceilings. Also check for rat-proofing and possible vermin entry ways.
- 13. Drinking water treatment, storage and distribution system. Thoroughly check the condition, location, etc., of filling hoses, filling port, water lines, identification, water tank, heating elements, distillation units, and outlets. Ensure that there are no system cross-connections and that hot and cold or warm running water is available for food service employees. Determine drinking water source.
- 14. Water systems other than drinking water, if present - describe the system and ensure that it is not cross-connected to the drinking water system and that outlets clearly indicate that it is not drinking water.
- 15. Conditions in the various lavatory areas, including water supply, availability of soap and towels, and general conditions.
When objectionable conditions are observed they must be described explicitly. Avoid imprecise words such as clean or dirty, but describe the observation in detail including quantity or extent and characteristics of the objectionable condition.
Collect physical samples for exhibit purposes and analyze when appropriate.
If there are questions regarding acceptability of food used aboard conveyances, use the following guidelines:
1. Commissaries, waste service areas, caterers, watering points, etc., must be under FDA's surveillance program (cooperative efforts with State/local health departments may be used) and must be maintained at an acceptable compliance level.
2. Ice - Contact health authorities to assist in determination if facility is not under FDA's inspectional program.
3. Shellfish - Must comply with requirements of FDA's National Shellfish Sanitation Program. Refer to the FDA's current Interstate Certified Shellfish Shippers List.
4. Milk - Under authority of 21 CFR 5.10(a)(4) and 21 CFR 1250.20-1250.26, milk and fluid milk products intended for use on interstate conveyances shall be from a source of supply approved by FDA. FDA's policy in this regard is contained in CPG 7158.01 which states in essence:
Only approved Grade "A" milk and milk products shall be used on interstate conveyances. Products/sources are considered approved for purposes of 21 CFR 1250.26 if they have a state or local permit, are under the routine inspection of a state or local regulatory agency and meet the provisions of the "Procedures Manual" of the Interstate Milk Shippers Program (including the Grade "A" Pasteurized Milk Ordinance and related technical documents). Interstate milk shippers may be used when they have been certified by the State Milk Sanitation authorities as having attained an acceptable milk sanitation compliance rating published in the quarterly FDA List titled Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers (IMS List). The IMS List does not provide direct information on suitability of frozen dessert sources that may also produce milk or fluid milk products.
5. Frozen Desserts - Must comply with requirements of FDA's "Frozen Dessert Processing Guidelines". dated 12/1/89.
6. Other Products - If the suitability of other products is questionable, such products must be in compliance with applicable sections of the Acts and regulations enforced by FDA. Where violative conditions are encountered, administrative sanctions under the ITS program may be applied.
C. Inspection Techniques, Specific
Depending on circumstances, this documentation may include photos, filth exhibits and other evidence. See IOM 520-Evidence Development and applicable Handbooks, etc. Correlate significant findings with construction activity and home region/district's compliance efforts. Based on the conveyance type and the general inspection techniques of Section 8, Part B, follow these specific guidelines:
Aircraft - Obtain clearance for boarding aircraft in advance of the inspection by contacting the station supervisor, ramp supervisor or other officials of the airline concerned. You may also board through caterers, but try to obtain clearance from the airline representative first. Airport inspections offer a good opportunity to inspect the entire aircraft for cleaning and maintenance and can be made when planes are in for turn-around stops or minor service. Although food may not be on-board, inspect the galley, waste compartments, and equipment for sanitation and maintenance. Also, check the water-service panels and toilet-service panels for cleanliness and protection.
As a minimum, include the following points:
- 1. Before departure, check if ovens are turned on (caterer or cabin attendant should do this). Check temperatures - 60oC (140oF), etc.
- 2. Check cold, 6oC (45oF), food and containers. Dry ice may be located in the back interior of container, on top of interior, or on the interior of the door.
- 3. Check ice drawers and containers (ice buckets, plastic bags, etc.) for cleanliness and foreign items such as soft drink cans, cups, olive jars, etc. Only ice should be in these containers.
- 4. Check for improper wet storage of milk cartons and individual coffee creamers.
- 5. Check the storage of single-service or single use items (paper cups, ice buckets, etc.). Often these items are improperly stored.
- 6. Food banks, stand-by rooms, and associated delivery vehicles, etc. are usually located at terminal areas. Check temperatures of products and of holding units. Carts often do not maintain the proper temperatures. Inquire from attendant or flight supervisor how long these foods were held in these banks since delivery from caterer. Generally include this inspection as part of a commissary or catering point.
- 7. Check the toilet-lavatory area for running hot and cold water, paper towels, and soap. It may not be turned on at the time of inspection.
- 8. The flight supervisor in many instances will be able to give you more information than the cabin attendants about catering services etc.
Railroad Food Service Cars - Equipment on railroad food service cars is compact and working space is limited aboard these conveyances. Even if the cars are quite new the mechanical equipment, particularly refrigerators, freezers and dish washing facilities may not be properly operating or maintained. Be on the alert for food held at hazardous temperatures, food that may be adulterated, storage of poisons or toxic materials, employee practices, vermin, and dirty food contact surfaces of equipment and utensils.
Occasionally food service supplies are stored in areas other than those located in food service cars. For example food supplies may be stored in crew dormitories. Food service operations (snack, beverage, etc.) may also be operated from temporary quarters, such as a sleeping or passenger area.
Food service operations on railroad cars are to be specifically evaluated on the provisions contained in the regulations, and in general, based on the guidelines contained in the ITS Handbooks and the Food Service Sanitation Manual.
A portion of these inspections should be made enroute so that all systems and operations may be observed.
When it is necessary to inspect non-food service passenger cars, the water, waste systems and pest control activities are the critical areas of operation.
Vessels - Passenger vessels (excluding work boats and supply vessels) have top inspection priority. Routine inspectional scheduling and coordinating with other involved regions/districts are essential for satisfactory FDA coverage. Cargo and related vessels and/or boats with crews of 10 or less should not be inspected on a routine basis. This does not exclude these vessels from FDA jurisdiction. Follow-up on complaints in accordance with region/ district procedures and instructions in IOM Chapter 9, and honor requests for inspection of small towboat or cargo vessels if personnel are available. For the definition of "vessels" refer to 21 CFR 1250.3
Foreign Flag vessels as well as American Flag vessels (deep draft vessels) operating in foreign traffic are under CDC's jurisdiction. The CDC contact is Chief, Vessel Sanitation Program, National Center for Environmental Health, CDC, 1015 North America Way, Miami, FL 33132, Tel (305) 536-4307, FAX (305) 536-4528. All passenger cruise vessels (including many "shallow-draft/mini") with scheduled international travel out of U.S. ports are an inspectional responsibility of CDC under 42 CFR 71. While such vessels may also be subject to FDA jurisdiction, this cooperative approach is resource and compliance effective. Other passenger vessels operating in interstate traffic are an FDA responsibility.
Vessel Inspection - Other than routine sanitation inspections, vessels may also be inspected for the following reasons:
- 1. When an inspection is requested of a vessel that is entering a shipyard for repairs (generally handle under construction activity).
- 2. Upon receipt of a complaint of insanitary conditions or report of illness aboard a vessel.
For vessel inspections, the following guidelines apply:
- 1. Make sure that all food service operations and related operations are conducted in accordance with good sanitation practice guidelines.
- 2. Check the drinking water storage tanks and distribution system to insure that the filling hoses are smooth-lined, clean, stored properly, and properly labeled.
- 3. Determine if the storage tanks are located and constructed to prevent possible contamination of their contents via manhole openings, inspection ports, filling, vent, overflow, drain and suction lines.
- 4. Check that there are no cross-connections between the drinking water system and any system of non-drinking quality. On vessels having high pressure type evaporators, the ship's engineers may cross-connect the drinking water system with fore and aft peak, double bottom, and wing (skin) tanks to supplement their drinking water supply during long sea voyages. These connections are usually located beneath the floor plates in remote areas and are sometimes difficult to locate and trace.
- 5. See that the drinking water distribution system is protected against backflow of contaminated liquids by use of properly installed air gaps or effective backflow preventers.
- 6. Determine whether an appropriate backflow preventer is installed on the ship-to-shore fire system connection to prevent back flow of non-potable liquids into the drinking water shore-piping system. Where cross-connections are found, recommend the immediate installation of a backflow preventer to correct the problem. Aseptically collect samples of water for bacteriological and chemical analysis, and if unsatisfactory results are obtained, recommend that the entire system be disinfected and flushed with drinking water from acceptable shore sources.
- 7. Check the condition and status of drinking water tank coatings or linings for compliance with the Food Additive Amendments or EPA requirements. See Section 7, Part B, Conveyance Construction.
- 8. Determine if the drinking water storage tanks and distribution system are being maintained as required.
- 9. Check water treatment equipment such as evaporators, chlorinators with retention tanks, and ultra violet light units, using the following guide:
- a. Evaporators - Check high pressure units to ensure that they are provided with a means to "waste" the distillate when it is unfit for use as drinking water.
- Check low pressure units to ensure that they are equipped with a low range electrical salinity indicator located beyond the final condensate cooler and a flow diversion valve, and that these controls are set to divert the flow of distilled water from the drinking water system when the current is off, or when the salinity of the condensate exceeds one-fourth grain per gallon.
- When there is evidence that a low-pressure plant does not produce water of one-fourth grain or less, or when fresh or brackish water feed is used, make sure there is a means for heating the distillate to 74oC (165oF) for 7 seconds, or for other adequate disinfection procedures and that this system is tied into the flow diversion valve.
- b. Chlorinators - When water is treated with chlorine, an automatic hypochlorinator is required. Batch chlorination is not acceptable. A holding tank of sufficient capacity to provide a contact period of 20 minutes for the chlorine and water is needed. This tank must be baffled to thoroughly mix the chlorine solution and water to minimize the possibility of short-circuiting the water through it. The free chlorine residual level in the distribution system must be 0.1 to 0.2 ppm.
- Wash water storage tanks or tanks used for storage of drinking water prior to final treatment may be formed by the skin of the vessel, deck, tank top, or partitions common with non-potable tanks, except sewage holding tanks, provided they are free of apparent leakage, and only non-sanitary drains pass through them.
- c. Ultra violet Lights - Check ultra violet light units for burned-out bulbs and determine that no bypass has been made around the unit. FDA-accepted units are designed to project a peak light intensity at 2,537 angstrom units, provide an energy dose of at least 16,000 microwatt seconds throughout the system, and meet other guidelines in the Handbook. Determine whether the safety controls such as flow control valve, intensity meter, and line voltage voltmeter are functioning properly.
- 10. Inspect waste disposal to ensure that the liquid waste drainage system is functioning properly; the system is vented and trapped; there are no cleanouts, flanged or threaded joints over food spaces, including utensil washing and storage rooms; food waste drain lines are provided with air breaks if discharged to human waste system; there is no possibility of backflow of sewage into food service or utensil washing equipment, drinking water and wash water system; garbage and trash is stored aboard the vessel in easily cleanable, covered containers and disposed of in a sanitary manner so as not to attract rats and insects, and create health or environmental hazards; and facilities for cleaning garbage containers are provided. Remember that EPA and the Coast Guard has primary responsibility for sewage treatment.
- (Attachment 13) (Back), and (Attachment 14)
and 'Handbooks' to assist in inspection of Support Facilities. Obtain and report information as to which carrier companies use the facility. Information on significant operating deficiencies that relate to construction of equipment or support facilities must be coordinated with other regions/ districts as necessary.
Catering Point/Commissary - When inspecting these facilities give attention to such items as internal temperatures of prepared foods, food-holding times and temperatures, and equipment such as slicers and choppers used for foods that will receive no further heat treatment before serving. In many instances, food furnished by a catering point is not served aboard an interstate conveyance until many hours after preparation. In addition, delays caused by rescheduling, late arrivals and departures, and equipment breakdowns may expose the finished meals to times and temperatures favorable to microbiological growth, with resulting illness to the passengers and/or crew. Inspect catering points/commissaries in accordance with the 1976 Food Service Sanitation Ordinance using form FD 2420, Food Service Establishment Inspection Report ( Attachment 8) (8 Back). The following areas require special attention:
- 1. See that all food is obtained from sources approved or considered satisfactory by FDA and is clean, wholesome, free from spoilage, free from adulteration and misbranding, and safe for human consumption.
- 2. Check to determine that all food is protected from contamination, and that all potentially hazardous food is quickly "cooled-down" and meets temperature requirements during storage, preparation, service and transportation. In regards to the holding of potentially hazardous food at improper temperatures: The requirement of the Food Service Code is that potentially hazardous food shall be maintained above 1400F or below 450F except during necessary periods of preparation, cooking or cooling. CFSAN's policy is, the period of time that a food may be out of the safe temperature zone shall not exceed 4 hrs. If you are unable to observe the entire preparation, cooking, and cooling period, a judgement based on actual observations along with employee interviews, can justify findings of noncompliance. The FDA-483 and EIR should clearly show the basis for determining that the time period the food was out of the safe temperature zone will, or did exceed the 4 hour limit.
- 3. See whether containers of food are stored above the floor in such a manner as to protect them from splash and other contamination and at a height that allows easy cleaning and minimizes the possibility of insect and rodent harborage.
- 4. Check that during the transportation of food from a catering establishment, all foods are in covered containers or completely wrapped or packaged so as to be protected from contamination and is maintained above 140oF or below 45o F.
- 5. See that only those poisonous and toxic materials required to maintain the establishment in a sanitary condition and to sanitize equipment and utensils are present in any area used in connection with food preparation.
- 6. Ascertain that ice served is made from water that comes from an approved source and determine if the ice has been manufactured, stored, transported, and handled in a sanitary manner.
- 7. Check that the caterer ensures that effective measures are taken to keep vermin out.
- 8. Determine if a caterer or carrier company utilizes a food bank for top-off meals and inspect all such facilities and related transport vehicles to insure that proper food protection and temperature controls are maintained.
- 9. Inspect operations and procedures of carriers who "dead-head" foods and supplies as cargo.
Watering Points - Check the following:
- 1. That the water supply and quality meet EPA requirements for use by conveyances.
- 2. Whether drinking water tanks (including barges, boats, etc)., used to transport water for drinking and culinary use on conveyances are properly constructed, operated, and stored, and are not used for any purpose that could adversely affect the quality of the water. This equipment must be constructed of smooth, heavy-gauge corrosion-resistant material, and must be completely enclosed from filling inlet to discharge outlet, except that vent openings are permitted when necessary if protected to prevent contamination of the water. The inlet and outlet to the tank must terminate in a downward direction or gooseneck, and must be provided with caps or closures with keeper chains for protection against contamination. The inlet and outlet must be equipped with couplings of a type that permits quick, easy attachment and removal of the hose. Threaded fittings on inlets and outlets to water tanks will be acceptable only with hoses that are permanently attached. The tanks must be designed so that they can be steamed and flushed, provided with a drain that permits complete drainage of the tank and labeled "Drinking Water Only."
- 3. See if hoses used to deliver drinking water are of satisfactory material, handled properly, and used for no other purpose.
- Neither the nozzle nor the hydrant end should be permitted to touch the ground or any contaminating materials. Guards, disks, or other devices that will protect the nozzle end of the hose from contamination are acceptable. Disks used as protective devices must be at least 6 inches in diameter and located not over 8 inches from the hose end.
- 4. Determine if the drinking water hoses are stored on reels, or in lockers or cabinets that are used for no other purpose, unless the hose ends are protected from contamination by suitable caps when not attached to conveyances, water carts, or hydrants.
- 5. Check that the hose is flushed thoroughly before being used.
- 6. Ascertain that the water delivery system for vessels is sized to permit adequate pressure and located above normal flood level. There must be no cross-connection with non-drinking water systems without an appropriate backflow prevention device in place. The hydrant outlet must be elevated at least 18 inches above the pier, and at least a single check valve must be installed on the discharge side of the final control valve. The hydrant outlets must be located and protected against possible contamination from vessel waste. If hoses are provided, they must be durable, smooth-lined, and stored properly to prevent possible contamination.
The use of booster pumps in pier supply lines is discouraged. However, if they are used, suitable controls are required, such as a pressure limiting switch on the suction side that must be set to shut off the pump when the pressure drops to 15 psi.
If drinking water is used to prime non-drinking water pumps, or to cool engines, machinery, etc., it must be delivered via air gaps to protect against backflow and contamination of drinking water systems.
Note that a water boat, (a vessel, boat, or barge) which carries drinking water for loading into drinking water tanks or other boats or vessels, is considered a watering point. Determine that the water supplied to the boat is from an approved source and pier facility, and that operations are conducted to prevent contamination during filling, storage, and delivery to other vessels.
Service Areas - When inspecting these determine if all sewage is disposed of in a public sewage system, or in a system approved by a State or local health authority. Inspect facilities in accordance with applicable "Handbooks" and inspection forms.
Ensure all water outlets in the waste disposal facility are protected with appropriate backflow prevention devices.
Particular attention should be paid to the way deodorant is introduced into the toilet service water in the lavatory\toilet servicing vehicle. Some airlines drop a package of dry chemical into the tank while others use a liquid preparation into a drum which is fed automatically into the water through an aspirator. There are have been cases where, due to reverse water pressure, toilet deodorant has contaminated the public water supply.
Observe employee practices for both water and waste servicing as management's explanation of the procedures quite often do not include the short cuts developed by the employees.
Ascertain whether toilets, locker rooms, and washrooms for servicing-area personnel are provided at convenient locations. Such facilities must be kept clean and in good repair and must include:
- 1. Toilet paper.
- 2. Handwashing facilities located in or adjacent to toilet rooms and elsewhere as needed, and an easily cleanable basin, a soap dispenser with soap, a clean-towel dispenser with towels, a soiled-towel receptacle, and piped warm (or hot and cold) water. (A warm-air jet, in lieu of towels, is satisfactory).
- 3. Signs instructing employees to wash their hands before resuming work posted in toilet rooms.
Drinking water, if provided for servicing-area personnel, must be of safe quality dispensed in a sanitary manner. Cups, glasses, or other drinking utensils that may be used by more than one person are not considered "dispensed in a sanitary manner." Only drinking water may be loaded into a bus's water system for drinking and/or culinary purposes. The lavatory spigot may be placarded "Not For Drinking" in accordance with EPA Guidelines.
Liquids, paper wastes and other garbage from galleys should be removed and stored in covered containers.
Pending removal and disposal, soiled motion sickness containers must be properly enclosed and stored in an upright position, apart from the galley area. Make sure personnel engaged in food or drinking-water service wash their hands after handling used motion sickness containers.
D. Wastes Discharged From Railroad
Although FDA can regulate waste discharge from freight, commuter, and certain other railroad operations, a statutory exemption precludes "intercity rail passenger service" (IRPS) from direct regulation. This exemption covers all AMTRAK cars except those operating in commuter service. These regulatory authorities are contained in 21 CFR 1250.51 - Railroad Conveyances: Discharge of Wastes. Provisions of these regulations address waste discharge from all types of railroad conveyances (e.g., passenger, freight locomotives and cabooses, commuter, excursion, business cars, etc.), however, an examination of a 1978 Report to Congress by HEW, along with the references and notes following 21 CFR 1250.51 reveals that AMTRAK is exempt from this regulation.
AMTRAK has advised FDA of a policy "to minimize the disposal of wastes in inappropriate locations". AMTRAK, in voluntary cooperation with the FDA has designed, constructed and operates post 1972 cars to incorporate measures for control of waste discharge. For example, certain cars (Amfleet & Metroliners) provide for complete retention of waste, while the Superliner cars contain systems providing retention only at speeds of less than 25 MPH. AMTRAK officials are considering resetting controls to provide retention at speeds up to 35 MPH.
As stated in the 1978 report, the current base level of compliance measures incorporated by AMTRAK in post 1972 cars represents the extent of control that FDA would require if its authority were reinstated by rescinding the current IRPS statutory exemption.
In older cars, AMTRAK uses placards, locking of toilets and other measures to prevent discharge of waste at stations and other such areas. Note however that Public Law # 101.610 dated November 16, 1990, requires installation of retention devices on Amtrak railcars by October 16, 1996.
With certain exemptions as outlined below, inspectional observations of "disposal of waste in inappropriate locations" such as stations, etc., should be reported to AMTRAK in a post-inspection letter. If there is no follow-up by AMTRAK, a subsequent "Referred to State" level of District Decision would be appropriate under FDA's authority (21 CFR 5.10(a)(2)) contained under section 311 of the PHS Act (42 U.S.C. 243). Where discharge of wastes represents an objectional condition at a watering point (under 21 CFR 1240.83(a)(2)), service area (under 21 CFR 1250.75(a),(b)) or caterer/commissary (under 21 CFR 1250.32(a)), a suitable compliance action must be initiated by the district against related establishment types U, V, J, and/or K.
Generally, FDA would object to Non-IRPS discharges at stations, in yards and other such areas during operations at speeds of less than 25 MPH; but should not object to enroute discharges while operating at speeds of greater than or equal to 25 MPH. Procedures standard to the ITS Program under PHS Act authorities should be followed for non-compliance.
The field is to continue conducting railroad related inspections, investigations and complaint follow-up and to document in detail, including photographs, all encounters with questionable waste discharge practices in stations and other such areas. The regions/districts should consult with CFSAN, Retail Food Protection Branch, Interstate Travel Sanitation Program (202) 205-8140, for questions, comments, or for regulatory guidance.
A. Federal-State Cooperation
Joint or cooperative inspectional programs or agreements with State or local agencies may be considered. Limit these agreements to State or local agencies having regulatory authority and the capability to effectively enforce their laws. Remember that this inspectional assistance must be equal to that performed by FDA; must generally be reported on FDA forms; must be planned and coordinated; and will require complete FDA action in areas such as industry notification and compliance actions, follow-up, and reporting. Refer to 42 USC 243 and 21 CFR 1240.83(b), 1240.90(b), 1250.25(b) and 1250.61.
Such agreements may be used for the analysis of culinary water samples collected and submitted by FDA.
Federal/State/local cooperation implemented under this program should be coordinated with the Division of Federal-State Relations, HFC-150.
FDA's emergency authorities for "measures in the event of inadequate local control" are contained under 21 CFR 1240.30 and requirements for "report of disease" by industry are contained in 21 CFR 1240.45.
B. Official Classification Lists
Official Classification Lists (OCL) are listings of in-compliance support facilities published to assist carrier companies in determining approved sources of supplies and services for their conveyances. OCLs our compiled from the OEI maintained by the districts; and cover vessel watering points, bus service areas; airline caterers, commissaries, watering points & waste service areas; and passenger train commissaries, watering points, and waste service areas.
At the current time OCLs are not being published although there are plans to reinstate them in the future. If there is a question on the status of any specific support facility this information can be obtained from CFSAN/Retail Food Protection Branch/ITS Program.
C. Food-Borne Illness - See IOM Chapter 9.
D. Technical Assistance Meetings
- Home districts for conveyance construction and operating companies and support facility operators should have an annual meeting with company management to:
- 1. Present FDA findings of conditions, trends or special problems discovered during inspections.
- 2. Discuss operations or construction plans of the firm in areas of interest to FDA, e.g., changes in sanitation procedures, new equipment or facilities, contracts for new conveyance construction, etc. Significant changes in operation should be disseminated to affected districts and CFSAN/ITS.
- 3. Offer to review operators' manuals, construction procedures, etc., for items of sanitation significance.
- 4. Offer assistance in arranging workshops or training for industry personnel.