§ 1250.53 Discharge of wastes on air

conveyances.

There shall be no discharge of excrement or garbage from any air conveyance except at servicing areas approved by the Commissioner of Food and Drugs.

[40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]

Subpart D-Servicing Areas for Land and Air Conveyances

§ 1250.60 Applicability.

Land and air conveyances engaged in interstate traffic shall use only such servicing areas within the United States as have been approved by the Commissioner of Food and Drugs as being in compliance with the requirements prescribed in this subpart.

[40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]

shall be adequately drained so as to prevent pooling.

§1250.67 Watering equipment.

(a) General requirements. All servicing area piping systems, hydrants, taps, faucets, hoses, buckets, and other appurtenances necessary for delivery of drinking and culinary water to a conveyance shall be designed, constructed, maintained and operated in such a manner as to prevent contamination of the water.

(b) Outlets for nonpotable water. Outlets for nonpotable water shall be provided with fittings different from those provided for outlets for potable water and each nonpotable water outlet shall be posted with permanent signs warning that the water is unfit for drinking.

(c) Ice. If bulk ice is used for the cooling of drinking water or other beverages, or for food preservation purposes, equipment constructed so as not to become a factor in the transmission of communicable diseases shall be provided for the storage, washing, handling, and delivery to conveyances of such bulk ice, and such equipment shall be used for no other purposes.

§ 1250.70 Employee conveniences.

(a) There shall be adequate toilet, washroom, locker, and other essential sanitary facilities readily accessible for use of employees adjacent to places or areas where land and air conveyances are serviced, maintained, and cleaned. These facilities shall be maintained in a clean and sanitary condition at all times.

(b) In the case of diners not in a train but with a crew on board, adequate toilet facilities shall be available to the crew within a reasonable distance but not exceeding 500 feet of such diners.

(c) Drinking fountains and coolers shall be constructed of impervious, nonoxidizing material, and shall be so designed and constructed as to be easily cleaned. The jet of a drinking fountain shall be slanting and the orifice of the jet shall be protected by a guard in such a manner as to prevent contamination thereof by droppings from the mouth. The orifice of such a jet shall be located a sufficient distance above the rim of the basin to prevent backflow.

§ 1250.75 Disposal of human wastes.

(a) At servicing areas and at stations where land and air conveyances are occupied by passengers the operations shall be so conducted as to avoid contamination of such areas and stations by human wastes.

(b) Toilet wastes shall be disposed of through sanitary sewers or by other methods assuring sanitary disposal of such wastes. All soil cans and removable containers shall be thoroughly cleaned before being returned to use. Equipment for cleaning such containers and for flushing nonremovable containers and waste carts shall be so designed as to prevent backflow into the water line, and such equipment shall be used for no purpose connected with the handling of food, water or ice. (c) All persons who have handled soil cans or other containers which have come in contact with human wastes shall be required to wash their hands thoroughly with soap and warm water and to remove any garments which have become soiled with such wastes before engaging in any work connected with the loading, unloading, transporting or other handling of food, water or ice.

$1250.79 Garbage disposal.

(a) Water-tight, readily cleanable, nonabsorbent containers with close-fitting covers shall be used to receive and store garbage.

(b) Can washing and draining facilities shall be provided.

(c) Garbage cans shall be emptied daily and shall be thoroughly washed before being returned for use.

Subpart E-Sanitation Facilities and Conditions on Vessels

§ 1250.80 Applicability.

The sanitation facilities and the sanitary conditions on vessels engaged in interstate traffic shall comply with the requirements prescribed in this subpart. provided that no major structural change will be required on existing vessels.

§ 1250.81 Inspection.

The Commissioner of Food and Drugs may inspect such vessels to determine

compliance with the requirements of this subpart.

[40 FR 5624, Feb. 6. 1975, as amended at 48 FR 11432. Mar. 18. 1983]

§1250.82 Potable water systems.

The following conditions must be met by vessel water systems used for the storage and distribution of water which has met the requirements of § 1240.80 of this chapter.

(a) The potable water system, including filling hose and lines, pumps, tanks, and distributing pipes, shall be separate and distinct from other water systems and shall be used for no other purposes.

(b) All potable water tanks shall be independent of any tanks holding nonpotable water or other liquid. All potable water tanks shall be independent of the shell of the ship unless (1) the bottom of the tank is at least 2 feet above the maximum load water line, (2) the seams in the shell are continuously welded, and (3) there are no rivets in that part of the shell which forms a side of a tank. A deck may be used as the top of a tank provided there are no access or inspection openings or rivets therein, and the seams are continuously welded. No toilet or urinal shall be installed immediately above that part of the deck which forms the top of a tank. All potable water tanks shall be located at a sufficient height above the bilge to allow for draining and to prevent submergence in bilge water.

(c) Each potable water tank shall be provided with a means of drainage and. if it is equipped with a manhole, overflow, vent, or a device for measuring depth of water, provision shall be made to prevent entrance into the tank of any contaminating substance. No deck or sanitary drain or pipe carrying any nonpotable water or liquid shall be permitted to pass through the tank.

(d) Tanks and piping shall bear clear marks of identification.

(e) There shall be no backflow or cross connection between potable water systems and any other systems. Pipes and fittings conveying potable water to any fixture, apparatus. or equipment shall be installed in such way that backflow will be prevented. Waste pipes from any part of the potable water system. including treatment

devices, discharging to a drain, shall be suitably protected against backflow.

(f) Water systems shall be cleaned, disinfected, and flushed whenever the Commissioner of Food and Drugs shall find such treatment necessary to prevent the introduction, transmission, or spread of communicable diseases.

[40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]

§ 1250.83 Storage of water prior to treatment.

The following requirements with respect to the storage of water on vessels prior to treatment must be met in order to obtain approval of treatment facilities under § 1240.90 of this chapter.

(a) The tank, whether independent or formed by the skin of the ship, deck, tank top, or partitions common with other tanks, shall be free of apparent leakage.

(b) No sanitary drain shall pass through the tank.

(c) The tank shall be adequately protected against both the backflow and discharge into it of bilge or highly contaminated water.

§ 1250.84 Water in galleys and medical care spaces.

(a) Potable water, hot and cold, shall be available in the galley and pantry except that, when potable water storage is inadequate, nonpotable water may be piped to the galley for deck washing and in connection with garbage disposal. Any tap discharging nonpotable water which is installed for deck washing purposes shall not be more than 18 inches above the deck and shall be distinctly marked "For deck washing only".

(b) In the case of existing vessels on which heat treated wash water has been used for the washing of utensils prior to the effective date of the regulations in this part, such water may continue to be so used provided controls are employed to insure the heating of all water to at least 170 °F before discharge from the heater.

(c) Potable water, hot and cold, shall be available in medical care spaces for hand-washing and for medical care purposes excluding hydrotherapy.

§ 1250.85 Drinking fountains and coolers; ice; constant temperature bottles.

(a) Drinking fountains and coolers shall be constructed of impervious, nonoxidizing material, and shall be so designed and constructed as to be easily cleaned. The jet of a drinking fountain shall be slanting and the orifice of the jet shall be protected by a guard in such a manner as to prevent contamination thereof by droppings from the mouth. The orifice of such a jet shall be located a sufficient distance above the rim of the basin to prevent backflow.

(b) Ice shall not be permitted to come in contact with water in coolers or constant temperature bottles.

(c) Constant temperature bottles and other containers used for storing or dispensing potable water shall be kept clean at all times and shall be subjected to effective bactericidal treatment after each occupancy of the space served and at intervals not exceeding one week.

§ 1250.86 Water for making ice.

Only potable water shall be piped into a freezer for making ice for drinking and culinary purposes.

§1250.87 Wash water.

Where systems installed on vessels for wash water, as defined in §1250.3(n), do not comply with the requirements of a potable water system, prescribed in § 1250.82, they shall be constructed so as to minimize the possibility of the water therein being contaminated. The storage tanks shall comply with the requirements of $1250.83, and the distribution system shall not be cross connected to a system carrying water of a lower sanitary quality. All faucets shall be labeled "Unfit for drinking".

§ 1250.89 Swimming pools.

(a) Fill and draw swimming pools shall not be installed or used.

(b) Swimming pools of the recirculation type shall be equipped so as to provide complete circulation, replacement, and filtration of the water in the pool every six hours or less. Suitable means of chlorination and, if necessary, other treatment of the water

shall be provided to maintain the residual chlorine in the pool water at not less than 0.4 part per million and the pH (a measure of the hydrogen ion concentration) not less than 7.0.

(c) Flowing-through types of salt water pools shall be so operated that complete circulation and replacement of the water in the pool will be effected every 6 hours or less. The water delivery pipe to the pool shall be independent of all other pipes and shall originate at a point where maximum flushing of the pump and pipe line is effected after leaving polluted waters.

§1250.90 Toilets and lavatories.

Toilet and lavatory equipment and spaces shall be maintained in a clean condition.

§ 1250.93 Discharge of wastes.

Vessels operating on fresh water lakes or rivers shall not discharge sewage, or ballast or bilge water, within such areas adjacent to domestic water intakes as are designated by the Commissioner of Food and Drugs.

CROSS REFERENCE: For Environmental Protection Agency's regulations for vessel sanitary discharges as related to authority under the Federal Water Pollution Control Act, as amended (33 U.S.C. 1314 et seq.), see 40 CFR part 140.

[40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432. Mar. 18, 1983]

§1250.95 Insect control.

Vessels shall be maintained free of infestation by flies, mosquitoes, fleas, lice, and other insects known to be vectors in the transmission of communicable diseases, through the use of screening, insecticides, and other generally accepted methods of insect control.

$1250.96 Rodent control.

Vessels shall be maintained free of rodent infestation through the use of traps, poisons, and other generally accepted methods of rodent control.

PARTS 1251-1269 [RESERVED]

PART 1270-HUMAN TISSUE INTENDED FOR TRANSPLANTATION

Subpart A-General Provisions

Sec.
1270.1 Scope.

1270.3 Definitions.

Subpart B-Donor Screening and Testing 1270.21 Determination of donor suitability for human tissue intended for transplantation.

Subpart C-Procedures and Records

1270.31 Written procedures.

1270.33 Records, general requirements. 1270.35 Specific records.

Subpart D-Inspection of Tissue Establishments

1270.41 Inspections. 1270.42 Human tissue offered for import. 1270.43 Retention, recall, and destruction of human tissue.

AUTHORITY: 42 U.S.C. 216, 243, 264, 271.

SOURCE: 62 FR 40444. July 29, 1997, unless otherwise noted.

Subpart A-General Provisions §1270.1 Scope.

(a) The regulations in this part apply to human tissue and to establishments or persons engaged in the recovery, screening, testing, processing, storage, or distribution of human tissue.

(b) Regulations in this chapter as they apply to drugs, biologics, devices, or other FDA-regulated commodities do not apply to human tissue, except as specified in this part.

(c) Regulations in this chapter do not apply to autologous human tissue.

(d) Regulations in this chapter do not apply to hospitals or other clinical facilities that receive and store human tissue only for transplantation within the same facility.

§ 1270.3 Definitions.

(a) Act for the purpose of this part means the Public Health Service Act, section 361 (42 U.S.C. 264).

(b) Blood component means any part of a single-donor unit of blood separated by physical or mechanical means.

(c) Colloid means a protein or polysaccharide solution that can be used to increase or maintain osmotic (oncotic) pressure in the intravascular compartment such as albumin, dextran, hetastarch; or certain blood components, such as plasma and platelets.

(d) Contract services are those functions pertaining to the recovery, screening, testing, processing, storage, or distribution of human tissue that another establishment agrees to perform for a tissue establishment.

(e) Crystalloid means a balanced salt and/or glucose solution used for electrolyte replacement or to increase intravascular volume such as saline, Ringer's lactate solution, or 5 percent dextrose in water.

(f) Distribution includes any transfer or shipment of human tissue (including importation or exportation), whether or not such transfer or shipment is entirely intrastate and whether or not possession of the tissue is taken.

(g) Donor means a human being, living or dead, who is the source of tissue for transplantation.

(h) Donor medical history interview means a documented dialogue with an individual or individuals who would be knowledgeable of the donor's relevant medical history and social behavior; such as the donor if living, the next of kin, the nearest available relative, a member of the donor's household, other individual with an affinity relationship, and/or the primary treating physician. The relevant social history includes questions to elicit whether or not the donor met certain descriptions or engaged in certain activities or behaviors considered to place such an individual at increased risk for HIV and hepatitis.

(i) Establishment means any facility under one management including all locations, that engages in the recovery, screening, testing, processing, storage, or distribution of human tissue intended for transplantation.

(j) Human tissue means any tissue derived from a human body, which:

(1) Is intended for transplantation to another human for the diagnosis, cure, mitigation, treatment, or prevention of any condition or disease;

(2) Is recovered, processed, stored, or distributed by methods that do not change tissue function or characteristics;

(3) Is not currently regulated as a human drug, biological product, or medical device;

(4) Excludes kidney, liver, heart, lung, pancreas, or any other vascularized human organ; and

(5) Excludes semen or other reproductive tissue, human milk, and bone mar

row.

(k) Importer of record means the person, establishment or their representative responsible for making entry of imported goods in accordance with all laws affecting such importation.

(1) Legislative consent means relating to any of the laws of the various States that allow the medical examiner or coroner to procure corneal tissue in the absence of consent of the donor's nextof-kin.

(m) Person includes an individual, partnership, corporation, association, or other legal entity.

(n) Physical assessment means a limited autopsy or recent antemortem or postmortem physical examination of the donor to assess for any signs of HIV and hepatitis infection or signs suggestive of any risk factor for such infections.

(0) Plasma dilution means a decrease in the concentration of the donor's plasma proteins and circulating antigens or antibodies resulting from the transfusion of blood or blood components and/or infusion of fluids.

(p) Processing means any activity performed on tissue, other than tissue recovery, including preparation, preservation for storage, and/or removal from storage to assure the quality and/or sterility of human tissue. Processing includes steps to inactivate and remove adventitious agents.

(q) Quarantine means the identification of human tissue as not suitable for transplantation, including human tissue that has not yet been characterized as being suitable for transplantation.