Food and Drug Administration, Department of Health and Human Services, per (initials of inspecting officer)."

(3) If samples are desired, the Chief of district shall immediately notify the District Director of Customs.

(4) The District Director of Customs at once shall forward samples, accompanied by description of shipment.

(5) When samples are desired from each shipment of containers, the chief of district shall furnish to District Director of Customs and deputies at ports within the district's territory a list of such containers, indicating the size of sample necessary. Samples should then be sent promptly on arrival of containers without awaiting special request.

(6) In all other particulars the procedure shall be the same at nonlaboratory ports as at laboratory ports, except that the time consumed in delivery of notices by mail shall be allowed for.

§ 1230.44 Samples.

On the same day that samples are requested by the district, the District Director of Customs or appraiser shall notify the importer that samples will be taken, that the containers must be held intact pending a notice of the result of inspection and analysis, and that in case the containers do not comply with the requirements of the Federal Caustic Poison Act, they must be returned to the District Director of Customs for disposition. This notification may be given by the District Director of Customs or appraiser through individual notices to the importer or by suitable bulletin notices posted daily in the customhouse.

§ 1230.45 No violation; release.

As soon as examination of the samples is completed, if no violation of the act is detected, the chief of the district shall send a notice of release to the importer and a copy of this notice to the District Director of Customs for his information.

§ 1230.46 Violation.

(a) If a violation of the Federal Caustic Poison Act is disclosed, the chief of the district shall send to the importer

due notice of the nature of the violation and of the time and place where evidence may be presented, showing that the containers should not be refused admission. At the same time similar notice regarding detention of the containers shall be sent to the District Director of Customs, requesting him to refuse delivery thereof or to require their return to customs custody if by any chance the containers were released without the bond referred to in §1230.41. The time allowed the importer for representations regarding the shipment may be extended at his request for a reasonable period to permit him to secure such evidence.

(b) If the importer does not reply to the notice of hearing in person or by letter within the time allowed on the notice, a second notice, marked "second and last notice," shall be sent at once by the chief of the district, advising him that failure to reply will cause definite recommendation to the District Director of Customs that the containers be refused admission and that the containers be exported within 3 months under customs supervision.

§ 1230.47 Rejected containers.

(a) In all cases where the containers are to be refused admission, the chief of the district within 1 day after hearing, or, if the importer does not appear or reply within 3 days after second notice, shall notify the District Director of Customs in duplicate accordingly.

(b) Not later than 1 day after receipt of this notice the District Director of Customs shall sign and transmit to the importer one of the copies, which shall serve as notification to the importer that the containers must be exported under customs supervision within 3 months from such date, as provided by law; the other notice shall be retained as office record and later returned as a report to the chief of the district. In all cases the importer shall return his notice to the District Director of Customs, properly certified as to the information required, as the form provides. § 1230.48 Relabeling of containers.

(a) If containers are to be released after relabeling, a notice shall be sent by the chief of district direct to the importer, a carbon copy being sent to the

District Director of Customs. This notice must state specifically the conditions to be performed, so as to bring the performance thereof under the provisions of the customs bonds on consumption and warehouse entries, these bonds including provisions requiring compliance with all of the requirements of the Federal Caustic Poison Act and all regulations and instructions issued thereunder. The notice will also state the officer to be notified by the importer when the containers are ready for inspection.

(b) The importer must return the notice to the District Director of Customs or chief of district, as designated, with the certificate thereon filled out, stating that he has complied with the prescribed conditions and that the containers are ready for inspection at the place named.

(c) This notice will be delivered to the inspection officer, who, after inspection, will endorse the result thereof on the back of the notice and return the same to the District Director of Customs or to the chief of district, as the case may be.

(d) When the conditions to be complied with are under the supervision of the chief of district, and these conditions have been fully met, he shall release the containers to the importer, sending a copy of the notice of release to the District Director of Customs for his information. If the containers have not been properly relabeled within the period allowed, the chief of district shall immediately give notice in duplicate to the District Director of Customs of the results of inspection. The District Director of Customs shall sign and immediately transmit one copy of the notice to the importer and proceed in the usual manner.

(e) If the containers are detained subject to relabeling to be performed under the supervision of the District Director of Customs, the District Director of Customs, as soon as relabeling is accomplished, will notify the importer that the containers are released.

(f) If the containers have not been properly relabeled within the period allowed, their sale after labeling as required by the act or other disposition

must be effected by the District Director of Customs.

(g) When the final action has been taken on containers which have been refused admission, sold. or otherwise disposed of as provided for by the act or which have been relabeled under the supervision of the District Director of Customs, he shall send to the chief of district a notice of such final action. giving the date and disposition.

(h) When relabeling is allowed the importer must furnish satisfactory evidence as to the identity of the containers before release is given. The relabeling must be done at a stated place and apart from other containers of a similar nature.

(i) When containers are shipped to another port for relabeling or exportation, they must be shipped under customs carrier's manifest, in the same manner as shipments in bond.

(j) District Directors of Customs will perform the inspection service whenever containers are to be exported, sold, or otherwise disposed of, and in other cases when there is no officer of the district available.

(k) District Directors of Customs and representatives of the district will confer and arrange the apportionment of the inspection service according to local conditions. Officers of the district will, whenever feasible, perform the inspection service in connection with relabeling.

§ 1230.49 Penalties.

(a) In case of failure to comply with the instructions or recommendations of the chief of district as to conditions under which containers may be disposed of, the District Director of Customs shall notify the chief of district in all cases coming to his attention within 3 days after inspection or after the expiration of the 3 months allowed by law if no action is taken.

(b) The chief of district, upon receipt of the above-described notice, and in all cases of failure to meet the conditions imposed in order to comply with the provisions of the Federal Caustic Poison Act coming directly under his supervision, shall transmit to the District Director of Customs such evidence as he may have at hand tending

Subpart A-General Provisions

§ 1240.3 General definitions.

As used in this part, terms shall have the following meaning:

(a) Bactericidal treatment. The application of a method or substance for the destruction of pathogens and other organisms as set forth in §1240.10.

(b) Communicable diseases. Illnesses due to infectious agents or their toxic products, which may be transmitted from a reservoir to a susceptible host either directly as from an infected person or animal or indirectly through the agency of an intermediate plant or animal host, vector, or the inanimate environment.

(c) Communicable period. The period or periods during which the etiologic agent may be transferred directly or indirectly from the body of the infected person or animal to the body of another.

(d) Contamination. The presence of a certain amount of undesirable substance or material, which may contain pathogenic microorganisms.

(e) Conveyance. Conveyance means any land or air carrier, or any vessel as defined in paragraph (n) of this section.

(f) Garbage. (1) The solid animal and vegetable waste, together with the natural moisture content, resulting from the handling, preparation, or consumption of foods in houses, restaurants, hotels, kitchens, and similar establishments, or (2) any other food waste containing pork.

(g) Incubation period. The period between the implanting of disease organisms in a susceptible person and the appearance of clinical manifestation of the disease.

(h) Interstate traffic. (1) The movement of any conveyance or the transportation of persons or property, including any portion of such movement or transportation which is entirely within a State or possession,

(i) From a point of origin in any State or possession to a point of destination in any other State or possession, or

(ii) Between a point of origin and a point of destination in the same State or possession but through any other State, possession, or contiguous foreign country.

(2) Interstate traffic does not include the following:

(i) The movement of any conveyance which is solely for the purpose of unloading persons or property transported from a foreign country, or loading persons or property for transportation to a foreign country.

(ii) The movement of any conveyance which is solely for the purpose of effecting its repair, reconstruction, rehabilitation, or storage.

(i) Milk. Milk is the product defined in § 131.110 of this chapter.

or

(j) Milk products. Food products made exclusively or principally from the lacteal secretion obtained from one more healthy milk-producing animals, e.g., cows, goats, sheep, and water buffalo, including, but not limited to, the following: lowfat milk, skim milk, cream, half and half, dry milk, nonfat dry milk, dry cream, condensed or concentrated milk products, cultured or acidified milk or milk products, kefir, eggnog, yogurt, butter, cheese (where not specifically exempted by regulation), whey, condensed or dry whey or whey products, ice cream, ice milk, other frozen dairy desserts and products obtained by modifying the chemical or physical characteristics of milk, cream, or whey by using enzymes, solvents, heat, pressure, cooling, vacuum, genetic engineering, fractionation, or other similar processes, and any such product made by the addition or subtraction of milkfat or the addition of safe and suitable optional ingredients for the protein, vitamin, or mineral fortification of the product.

(k) Minimum heat treatment. The causing of all particles in garbage to be heated to a boiling temperature and held at that temperature for a period of not less than 30 minutes.

(1) Possession. Any of the possessions of the United States, including Puerto Rico and the Virgin Islands.

(m) Potable water. Water which meets the standards prescribed in the Environmental Protection Agency's Primary Drinking Water Regulations as set forth in 40 CFR part 141 and the Food and Drug Administration's sanitation requirements as set forth in this part and part 1250 of this chapter.

(n) State. Any State, the District of Columbia, Puerto Rico and the Virgin Islands.

con

(0) Utensil. Includes any kitchenware, tableware, glassware, cutlery, tainers, or equipment with which food or drink comes in contact during storage, preparation, or serving.

(p) Vessel. Any passenger-carrying, cargo, or towing vessel exclusive of:

(1) Fishing boats including those used for shell-fishing;

(2) Tugs which operate only locally in specific harbors and adjacent waters; (3) Barges without means of self-propulsion;

(4) Construction-equipment boats and dredges; and

(5) Sand and gravel dredging and handling boats.

(q) Watering point. The specific place or water boat from which potable water is loaded on a conveyance.

(r) Molluscan shellfish. Any edible species of fresh or frozen oysters, clams, mussels, and scallops or edible portions thereof, except when the product consists entirely of the shucked adductor muscle.

(s) Certification number means a unique combination of letters and numbers assigned by a shellfish control authority to a molluscan shellfish processor.

(t) Shellfish control authority means a Federal, State, or foreign agency, or sovereign tribal government, legally responsible for the administration of a program that includes activities such as classification of molluscan shellfish growing areas, enforcement of molluscan shellfish harvesting controls, and certification of molluscan shellfish processors.

(u) Tag means a record of harvesting information attached to a container of shellstock by the harvester or proc

essor.

[40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18. 1983; 57 FR 57344, Dec. 4, 1992; 60 FR 65201, Dec. 18, 1995]

§ 1240.10 Effective bactericidal treatment.

Whenever, under the provisions of this part, bactericidal treatment is required, it shall be accomplished by one or more of the following methods:

(a) By immersion of the utensil or equipment for at least 2 minutes in clean hot water at a temperature of at least 170 °F or for one-half minute in boiling water;

(b) By immersion of the utensil or equipment for at least 2 minutes in a lukewarm chlorine bath containing at least 50 ppm of available chlorine if hypochlorites are used or a concentration of equal bactericidal strength if chloramines are used;

(c) By exposure of the utensil or equipment in a steam cabinet at a temperature of at least 170 °F for at least 15 minutes or at a temperature of 200 °F for at least 5 minutes;

(d) By exposure of the utensil or equipment in an oven or hot air cabinet at a temperature of at least 180 °F for at least 20 minutes;

(e) In the case of utensils or equipment so designed or installed as to make immersion or exposure impractical, the equipment may be treated for the prescribed periods of time either at the temperatures or with chlorine solutions as specified above, (1) with live steam from a hose if the steam can be confined, (2) with boiling rinse water, or (3) by spraying or swabbing with chlorine solution;

(f) Any other method determined by the Commissioner of Food and Drugs, upon application of an owner or operator of a conveyance, to be effective to prevent the spread of communicable disease.

[40 FR 5620, Feb. 6, 1975, as amended at 54 FR 24900, June 12, 1989]

Subpart B-Administrative Procedures

§ 1240.20 Issuance and posting of certificates following inspections.

The Commissioner of Food and Drugs may issue certificates based upon inspections provided for in this part and part 1250. Such certificates shall be prominently posted on conveyances.

[40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983]

§ 1240.30 Measures in the event of inadequate local control.

Whenever the Commissioner of Food and Drugs determines that the meas

ures taken by health authorities of any State or possession (including political subdivisions thereof) are insufficient to prevent the spread of any of the communicable diseases from such State or possession to any other State or possession, he may take such measures to prevent such spread of the diseases as he deems reasonably necessary, including inspection, fumigation, disinfection, sanitation, pest extermination, and destruction of animals or articles believed to be sources of infection.

[40 FR 5620. Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983]

§ 1240.45 Report of disease.

The master of any vessel or person in charge of any conveyance engaged in interstate traffic, on which a case or suspected case of a communicable disease develops shall, as soon as practicable, notify the local health authority at the next port of call, station, or stop, and shall take such measures to prevent the spread of the disease as the local health authority directs.

Subpart C [Reserved]

Subpart D-Specific Administrative Decisions Regarding Interstate Shipments

§ 1240.60 Molluscan shellfish.

(a) A person shall not offer for transportation, or transport, in interstate traffic any molluscan shellfish handled or stored in such an insanitary manner, or grown in an area so contaminated, as to render such molluscan shellfish likely to become agents in, and their transportation likely to contribute to the spread of communicable disease from one State or possession to another.

(b) All shellstock shall bear a tag that discloses the date and place they were harvested (by State and site), type and quantity of shellfish, and by whom they were harvested (i.e., the identification number assigned to the harvester by the shellfish control authority, where applicable or, if such identification numbers are not assigned, the name of the harvester or the name or registration number of the harvester's vessel). In place of the tag,