§ 85.14 Suspension and withdrawal of inspection service.

(a) The Administration may suspend and the Secretary may withdraw inspection service in any establishment:

(1) Upon failure of the packer to comply with any applicable provision of §§ 85.1 through 85.14; or

(2) Upon the dissemination by the packer or any person in privity with him of any representation that is false or misleading in any particular regarding the application to any seafood of the inspection service provided by the regulations in this part.

(b) When inspection service is suspended in an establishment, as authorized by paragraph (a) of this section, the Administration shall not lengthen the inspection period in such establishment to compensate for any of the time of suspension.

Subpart B-Inspection of Canned Oysters

(a) Applications for inspection service on canned oysters under the provisions of section 702a of the Federal Food, Drug, and Cosmetic Act shall be on forms supplied by the Food and Drug Administration, referred to in this subpart as the administration. No application for a regular inspection period filed with the Administration after September 1 preceding such period in any year shall be considered unless the applicant shows substantial cause for failure to file such application on or before September 1 of such year. The opening date of the canning season in each State shall be the date set by the State agency responsible for controlling the opening date of the canning season in that State. A separate application shall be made for each inspection period in each establishment for which the service is applied. Each application for a regular inspection period shall be accompanied by a payment of $600.00 as prescribed by § 85.28 (a) (1). Such deposit shall be paid in the manner prescribed by § 85.28 (e).

(b) For the purpose of 88 85.16 through 85.29, an establishment is defined as a factory where oysters may be processed and warehouses under the control and direction of the packer where such canned oysters are stored.

§ 85.17 Granting or refusing inspection service; cancellation of application. (a) The Secretary of Health, Education, and Welfare may grant the inspection service applied for upon determining that the establishment covered by such application complies with the requirements of § 85.21.

(b) The Secretary may refuse to grant the inspection service at any establishment for cause. In case of refusal the applicant shall be notified of the reason therefor and shall have returned to him all advance payments and production deposits made, less any expenses incurred for preliminary inspection of the establishment, or for other purposes incident to such application.

(c) The applicant, by written notice to the Secretary, may withdraw his application for inspection service before an inspector is assigned to the establishment. In case of such withdrawal, the Secretary shall return to such applicant all advance payments and production deposits made, less any salary and other expense incurred incident to such application.

§ 85.18 Inspection periods.

(a) The regular inspection period in each establishment in which inspection service under §§ 85.16 through 85.29 is granted consists of 4 consecutive months. The date of the beginning of such regular inspection period shall be regarded as the date, on or after October 1 but not later than March 1, specified for the beginning of the service in the application therefor, or such other date as may be specified by amendment to such application and approved; but if the Secretary is not prepared to begin the service on the specified date then the period shall start on the date on which service is begun.

(b) Extension inspection periods shall begin at the close of the preceding inspection period. Extension inspection periods may be granted for periods of 1 month and/or fractional parts of 1 month, but in no case less than 1 day. Extension inspection periods for 1 month may be granted in such establishment if application therefor, accompanied by a payment of $600.00, as prescribed by § 85.28 (a) (3), is made at least 2 weeks in advance of the close of such preceding inspection period. Applications for extension inspection periods for fractional parts of a month may be accepted when

accompanied by the payment prescribed by § 85.28 (a) (3) for such extensions. No regular or extension inspection period shall extend beyond June 30 of any year.

(c) Upon request of the packer, and with the approval of the Administration, such service during any inspection period may be transferred from one establishment to another to be operated by the same packer; but such transfer shall not serve to lengthen any inspection period or to take the place of an extension inspection period. In case of such transfer the packer shall furnish all necessary transportation of inspectors.

(d) The inspection service shall be continuous throughout the inspection period.

§ 85.19 Assignment of inspectors.

(a) An initial assignment of at least one inspector shall be made to each establishment in which inspection service under §§ 85.16 through 85.29 is granted. Thereafter, the Administration shall adjust the number of inspectors assigned to each establishment and tour of duty of each inspector to the requirements for continuous and efficient inspection.

(b) Any inspector of the Administration shall have free access at all times to all parts of the establishment and to all fishing and freight boats and other conveyances dredging oysters for or transporting oysters to such establishments. § 85.20 Uninspected oysters excluded from inspected establishments.

(a) No establishment to which inspection service on canned oysters has been granted shall at any time thereafter can oysters that have not been so inspected, or handle or store in such establishment any canned oysters that have not been so inspected; but this paragraph shall not apply to an establishment after termination of inspection service therein, or withdrawal therefrom as authorized by § 85.29.

(b) All oysters delivered to or held in an inspected establishment may be subject to inspection, but certificates of inspection shall be issued under § 85.27 only on canned oysters.

or other approved insect-control devices shall be installed.

(b) Shucking sheds and packing rooms shall be separate, and fixtures and equipment shall be so constructed and arranged as to permit thorough cleaning. Such sheds and rooms shall be adequately lighted and ventilated, and the floors shall be tight and arranged for thorough cleaning and proper drainage. Open drains from shucking shed shall not enter packing room. If shucking shed and packing room are in separate buildings, such buildings shall be not more than 100 yards apart, unless adequate provisions are made to enable efficient inspection.

(c) All surfaces of washers, tanks, belts, tables, flumes, utensils, and other equipment with which unshucked or shucked oysters come in contact after delivery to the establishment shall be of metal or of other smooth nonporous and easily cleanable material, provided such materials are not lead or other toxic substances. Metal seams shall be smoothly soldered or smoothly welded. Shucking

tables shall be so constructed as to preclude contamination of working surfaces or products thereon from foot traffic or wheelbarrows or other containers used in delivering steamed oysters to such tables.

(d) Adequate supplies of suitable detergents and sanitizing agents approved by the Administration; clean, unpolluted running water; and steam shall be provided for washing, cleaning, and otherwise maintaining the establishment in a sanitary condition.

(e) Adequate toilet facilities of sanitary type which comply fully with applicable State laws and local ordinances shall be provided.

(f) An adequate number of sanitary washbasins, with liquid or powdered soap, shall be provided in both the shucking shed and the packing room. Paper towels shall be provided in the packing

room.

(g) Signs requiring employees handling oysters to wash their hands after each absence from post of duty shall be conspicuously posted in the shucking shed and packing room and elsewhere about the premises as conditions require.

(h) One or more suitable washing devices and one or more suitable inspection belts shall be installed for the washing and subsequent inspection of the oysters before delivery for steaming or other means of opening.

(1) If steam boxes are used for opening the oysters, they shall be provided with adequate steam inlets, exhausts, drains, a safety valve, and a pressure gauge.

(j) Suitable means shall be provided for removing shells and debris from shucking shed.

(k) One or more suitable devices shall be provided for removing shell and grit from shucked oysters, for washing such oysters, and for their subsequent drainage.

(1) One or more suitable inspection belts shall be installed for the inspection of shucked oysters.

(m) Equipment shall be provided for code-marking cans.

(n) An automatic container-counting device shall be installed in each cannery line.

(0) Each sterilizing retort shall be fitted with at least the following equipment:

(1) An automatic control for regulating temperatures.

(2) An indicating mercury thermometer of a range from 170° F. to 270° F., with scale divisions not greater than 2o F., installed either within a fitting attached to the shell of the retort or within the door or shell of the retort. If the thermometer is installed within a fitting, such fitting shall communicate with the chamber of the retort through an opening at least 1 inch in diameter. Such fitting shall be equipped with a bleeder at least 8-inch in diameter. If the thermometer is installed within the door or shell of the retort, the bulb shall project at least two-thirds of its length into the principal chamber.

(3) A recording thermometer of a range from 170° F. to 270° F., with scale divisions not greater than 2° F. The bulb of such thermometer shall be installed as prescribed for the indicating mercury thermometer. The case which houses the charts and recording mechanism shall be provided with an approved lock, all keys to which shall be in the sole custody of the inspector.

(4) A pressure gauge of a range from 0 to 30 pounds, with scale divisions not greater than 1 pound and diameter of not less than 5 inches. Such gauge shall be connected to the chamber of the retort by a short gooseneck tube. The gauge shall be not more than 4 inches higher than the gooseneck.

(5) A blow-off vent of at least 34-inch inside diameter in the top of the retort.

(6) A %-inch bleeder in top of the retort.

(p) Suitable space and facilities shall be provided for the inspector to prepare records and examine samples and for the safekeeping of records and equipment. § 85.22 General operating conditions.

(a) The decks and holds of all boats tonging or dredging oysters for or transporting oysters to an inspected establishment, and the bodies of other conveyances so transporting oysters shall be kept in a sanitary condition. Such boats shall be equipped with adequate means for protecting the oysters against contamination with bilge water.

(b) Inspected establishments, freight boats, and other conveyances serving such establishments shall accept only live, clean, sound oysters taken from unpolluted areas. When necessary, ice or other suitable refrigeration shall be provided to prevent spoilage.

(c) After delivery of each load of oysters to the establishment, decks and holds of each boat and the body of each other conveyance or container making such delivery shall be washed down with clean, unpolluted water, and all debris shall be cleaned therefrom before such boat or other conveyance or container leaves the establishment premises.

(d) Before being steamed or opened by other means, the oysters shall be washed with clean, unpolluted water and then passed over the inspection belt and culled to remove dirty, muddy, dead, or decomposed oysters and extraneous material. Muddy oysters may be returned to the washer for rewashing.

(e) As often as is necessary to maintain sanitary conditions, unloading platforms and equipment shall be washed with clean, unpolluted water, and all debris shall be cleaned therefrom.

(f) Shells shall be removed from the shucking shed continuously.

(g) Offal, debris, or refuse from any source whatever shall not be allowed to accumulate in the cannery or, except for shells, about the premises. Shells shall not be allowed to accumulate about the premises in such a manner as to create a nuisance.

(h) The delivery of steamed oysters to shuckers by means of manually rolling, trundling, or wheelbarrowing such oysters on or above shucking tables will not be permitted.

(i) Shucking knives and shucking cups shall be thoroughly washed with soap

and water and chlorinated before use each day. Chlorine solution shall be maintained at a strength of 200 parts per million.

(j) No shucked oysters shall be returned to shucker after delivery to the weigher. Shucking cups shall be cleaned and sanitized after each delivery to the weigher.

(k) Shucked oysters being transported from one building to another shall be properly covered and protected against contamination.

(1) The shucked oysters shall be washed, separated from the shell and grit by suitable devices, and then immediately drained. The time of washing shall not exceed the minimum time necessary for cleansing.

(m) From the time of delivery to the cannery up to the time of final processing, oysters shall be handled expeditiously and under such conditions as to prevent contamination or spoilage.

(n) The packer shall destroy for food purposes under the immediate supervision of the inspector all oysters in his possession condemned by the inspector as filthy, decomposed, putrid, or unfit for food. Oysters condemned on the boat or on the unloading platform shall not be taken into the cannery, but shall be either destroyed or returned to a bedding ground.

(o) All portions of the establishment shall be adequately lighted to enable the inspector to perform his duties properly.

(p) All floors and other parts of the establishment including unloading platforms, and all fixtures, equipment, and utensils shall be cleaned as often as may be necessary to maintain them in a sanitary condition.

(q) The packer shall require all employees handling oysters to wash their hands after each absence from post of duty and to observe other proper habits of cleanliness.

(r) The packer shall not knowingly employ in or about the establishment any person afflicted with an infectious or contagious disease or with any open sores on exposed portions of the body.

§ 85.23 Code marking.

(a) Code marks shall be affixed to all cans and other immediate containers before they are placed in the processing retorts. Such marks shall show at least: (1) The date of packing;

(2) The establishment where packed; (3) The conveyance; and

(4) The size of the oysters when such oysters are graded for size.

(b) Keys to all code marks shall be given to the inspector.

(c) Each lot shall be stored separately pending final inspection, with a space of not less than 6 inches between stacks of each lot. For the purposes of the regulations in this part all cans or other containers bearing the same code marks shall be regarded as comprising a lot. § 85.24 Processing.

(a) The closure of the can or other immediate container and the time and temperature of sterilizing the canned oysters shall be adequate to prevent bacterial spoilage.

(b) The following times and temperatures shall be the minimum employed for the containers indicated:

For the purposes of this section, initial temperature is defined as the average temperature of the contents of the container at the moment steam is admitted to the sterilizing retort.

(c) The blow-off vent shall be open during the coming-up period until the mercury thermometer registers at least 215° F. Bleeders shall emit steam during the entire cooking period.

(d) The inspector shall identify each record on the thermometer chart with the code mark of the lot to which such record relates and the date of such record. The Administration shall keep such charts for at least 5 years, and upon request shall make them available to the packer.

(e) The packer shall keep for at least 2 years all shipping records covering shipments from each lot, and upon request shall furnish such records to any inspector of the Administration.

[20 FR. 9631, Dec. 20, 1955, as amended at 22 FR. 891, Feb. 13, 1957]

§ 85.25 Examination after canning.

(a) Adequate samples shall be drawn by the inspector from each lot of canned

The

(b) Two proofs, or one proof and one photostat thereof, or eight specimens of all labeling intended for use on inspected canned oysters or on or within the cases therefor shall be submitted to the Administration for approval. If proofs or photostat and proof are submitted, eight specimens of the labeling shall be sent to the Administration after printing. Administration is hereby authorized to approve labeling for use on canned oysters inspected under §§ 85.16 through 85.29. Approval shall be subject to the condition that such labeling shall be so used as to comply with the provisions of the Federal Food, Drug and Cosmetic Act, amendments thereto, and regulations thereunder. The Administration is also authorized to revoke any such approval for cause. The Administration shall not approve labeling for canned oysters intended for export under the provisions of § 85.27 (e).

(c) No commercial brand or brand name appearing on labeling approved as authorized under paragraph (b) of this section and bearing the mark described in paragraph (a) of this section, and no labeling simulating any such approved labeling, shall be used after such approval on canned oysters other than those that have been handled, prepared, and packed in compliance with all provisions of §§ 85.16 through 85.29; but this section shall not apply to any packer's labeling not bearing such mark after termination of inspection or withdrawal thereof as authorized by § 85.29 or to any distributor's labeling not bear

ing such mark after written notice by the owner thereof to the Administration that the use of such labeling on inspected canned oysters has been discontinued and will not be resumed.

(d) Canned-oyster labeling authorized by paragraph (a) of this section or approved under paragraph (b) of this section shall be used only as authorized by §§ 85.16 through 85.29. Unauthorized use of such labeling renders the user liable to the penalties prescribed by the Food, Drug, and Cosmetic Act, as amended.

§ 85.27

Certificates of inspection; warehousing and export permits.

(a) After finding that the canned oysters comprising any parcel have been handled, prepared, and packed in compliance with all provisions of §§ 85.16 through 85.29; bear labeling approved as authorized under § 85.26(b); and comply with all the provisions of the Federal Food, Drug, and Cosmetic Act, amendments thereto, and regulations thereunder, the inspector shall issue certificate showing that such canned oysters so comply. The certificate shall specify the code marks to which it applies, the quantity of the parcel so marked, the place where such parcel is stored, the size and kind of containers, the commercial brand name on the labels, the condition of the oysters if they are broken or if they are substandard in fill, and the destination of the lot, if known. Such certificate shall become void if such labeling is removed, altered, obliterated, or replaced; but such canned oysters may be relabeled under supervision of an inspector and recertified if the inspector finds that, after being relabeled, they comply with the requirements laid down by this paragraph for the issuance of a certificate.

(b) Unless covered by certificate, canned oysters shall be moved from an inspected establishment only for storage authorized under paragraph (c) of this section, or for export authorized under paragraph (e) of this section, or for destruction as provided by § 85.25 (b).

(c) Applications to move unlabeled canned oysters for storage in a warehouse elsewhere than in the establishment where such oysters were packed shall be on forms supplied by the Administration. The application shall give the name and location of the warehouse in which such canned oysters are to be stored, and shall be accompanied by an