6 CRR-NY 42.15NY-CRR
6 CRR-NY 42.15
6 CRR-NY 42.15
42.15 Microbiological cleansing of shellfish.
(a) Applicability.
The provisions of this section shall apply to any person operating or responsible for the operation of facilities, buildings and structures used for the microbiological cleansing of shellfish for use as food for human consumption.
(b) General prohibitions.
(1) No person shall operate a facility, building or structure for the microbiological cleansing of shellfish without a valid class B shipper's permit and a valid shellfish microbiological cleansing operator's permit issued by the department.
(2) No person shall construct a new facility, building or structure, nor alter an existing facility, building or structure for the microbiological cleansing of shellfish, unless and until the plans therefor have been submitted to and approved by the department.
(3) No person shall be issued a microbiological cleansing operator's permit by the department until such person's facilities, building, structures and equipment are in compliance with applicable provisions of this Part and until such person submits acceptable evidence to the department that such facilities will microbiologically cleanse shellfish in compliance with the requirements of this section and applicable provisions of this Part.
(c) Microbiological cleansing activities.
(1) General prohibitions.
(i) No person engaged in the microbiological cleansing of shellfish shall fail to designate a person, approved by the department as a permit condition, to provide supervision of employees and microbiological cleansing operations.
(ii) No person engaged in the microbiological cleansing of shellfish shall fail to designate a laboratory, approved by the department as a permit condition, to perform laboratory examinations of shellfish, water and other materials. In order for such laboratory examinations to be acceptable to the department, such laboratory shall have received and shall maintain a satisfactory evaluation by the United States Department of Health and Human Services, Public Health Service, Food and Drug Administration. Such laboratory shall provide the department, by mail or other acceptable methods, with copies of all laboratory examination results as soon as possible after such results are available.
(iii) No person engaged in the microbiological cleansing of shellfish shall obtain shellfish for such purpose from any person other than a person possessing a valid shellfish digger's permit and a valid shellfish microbiological cleansing-harvester's permit issued by the department; and no such person shall receive shellfish on a specific day for such purpose unless such person has sufficient cleansing tank capacity to begin the cleansing of such shellfish on such specific day.
(iv) No person engaged in the microbiological cleansing of shellfish shall fail to designate the persons, approved by the department as a permit condition, from whom shellfish for microbiological cleansing will be obtained.
(v) No person engaged in the microbiological cleansing of shellfish shall utilize a tank for such purpose which does not have safe, smooth, easily cleanable cleansing water contact surfaces. Tanks used for such purpose shall provide uniform flows of cleansing water throughout such tanks.
(vi) No person engaged in the microbiological cleansing of shellfish shall utilize a tank for a purpose other than the microbiological cleansing of shellfish during the duration of the term of the applicable shellfish microbiological cleansing operator's permit.
(vii) No person engaged in the microbiological cleansing of shellfish shall fail to identify each such tank used for such purpose with a clearly visible number or letter.
(viii) No person engaged in the microbiological cleansing of shellfish shall fail to keep tanks used for such purpose orderly, in good repair and sanitary; and no such person shall fail to keep such tanks protected from and free from flooding, stormwater runoff, pets, wild and domestic animals and other agents or forms of contamination.
(ix) No person engaged in the microbiological cleansing of shellfish shall fail to utilize a tank for such purpose which is self-draining to facilitate cleaning.
(x) No person engaged in the microbiological cleansing of shellfish shall fail to supply water to tanks used for such purpose that is from a source approved by the department as a permit condition. Such source water shall have, prior to disinfection treatment, a median total coliform MPN per 100 milliliters of sample of 700 or less, and ordinarily no more than 10 percent of the samples shall have a total coliform MPN per 100 milliliters of sample in excess of 3300 (using a three-tube multiple dilution fermentation tube test).
(xi) No person engaged in the microbiological cleansing of shellfish shall fail to supply water to tanks used for such purpose that is in the range of 10 grams per kilogram (10 parts per thousand), as a minimum, and 31 grams per kilogram (31 parts per thousand), as a maximum, except that the degree of salinity shall be approximately equal (100 percent plus or minus 20 percent) to that of the harvest waters when the commissioner determines as a permit condition, that such an approximation is necessary. Artificial sea water mixtures may be used to obtain the required salinity, provided that such mixtures are approved by the department as a permit condition. The use of mixtures intended for brine preparations is prohibited.
(xii) No person engaged in the microbiological cleansing of shellfish shall fail to supply water to tanks used for such purpose that has a total coliform MPN per 100 milliliters of sample of less than two (using a five-tube multiple dilution fermentation tube test or an equivalent test approved by the department as a permit condition), that has a turbidity of 20 Jackson turbidity units or lower and in a manner that will not prevent or impede the proper microbiological cleansing of shellfish.
(xiii) No person engaged in the microbiological cleansing of shellfish shall fail to supply water to tanks used for such purpose through safe piping, valves and pumps of such design as to be easily cleanable. Pipes, valves and pumps shall be washed free of cleaning and/or sanitizing agents before the use of such pipes, valves and pumps for the microbiological cleansing of shellfish. Water contact surfaces in pipes, valves and pumps should be constructed from approved plastics. Water contact surfaces containing copper or copper alloys are not recommended.
(xiv) No person engaged in the microbiological cleansing of shellfish shall fail to supply a continuous flow of water to tanks used for such purpose at a rate providing at least one gallon per minute for each bushel of shellfish being cleansed therein and at a rate providing at least one gallon per minute per the bushel-rated capacity of each such tank.
(xv) No person engaged in the microbiological cleansing of shellfish shall fail to provide a permanently installed, accurate and appropriate flow meter for each tank used for such purpose or have available approved devices for easily measuring water flow rates.
(xvi) No person engaged in the microbiological cleansing of shellfish shall fail to maintain water in tanks used for such purpose with a degree of dissolved oxygen of five milligrams per liter or higher.
(xvii) No person engaged in the microbiological cleansing of shellfish shall utilize a reservoir tank for cleansing water storage which is not of watertight construction and condition; and no such person shall fail to keep such a tank orderly and in good repair; and no such person shall fail to keep such a tank protected from and free from flooding, stormwater runoff, pets, wild and domestic animals and other agents or forms of contamination. Reservoir tanks shall be drained of water and cleaned at least once each week when in use.
(xviii) No person engaged in the microbiological cleansing of shellfish shall fail to replace germicidal lamp tubes and/or ultraviolet light source lamp tubes used for the destruction of microorganisms in cleansing water when such lamps have been in use for a maximum of 7,500 hours or when such lamps have an intensity determined to be at least 60 percent of the original intensity. Such germicidal lamp tubes or ultraviolet light sources and their chambers shall be washed free of scale or other deposits after the microbiological cleansing of each lot of shellfish.
(xix) No person engaged in the microbiological cleansing of shellfish shall fail to provide approved cleansing water aeration devices and/or approved cleansing water cooling devices and/or approved cleansing water warming devices and/or approved cleansing water filtration devices when the department determines as a permit condition that such devices are necessary.
(xx) No person engaged in the microbiological cleansing of shellfish shall fail to provide approved constant recording devices for the monitoring of ultraviolet light intensity and/or cleansing water flow rates and/or cleansing water temperatures when the department determines as a permit condition that such devices are necessary.
(xxi) No person engaged in the microbiological cleansing of shellfish shall fail to begin the microbiological cleansing of shellfish as soon as possible after the receipt of such shellfish. Non-microbiologically cleansed shellfish harvested from uncertified shellfish lands shall not be stored overnight in a facility, building or structure used for the microbiological cleansing of shellfish without permission of the department.
(xxii) No person engaged in the microbiological cleansing of shellfish shall fail to assign and record a lot number for each day's harvest of shellfish from a specific harvest area; and no such person shall cause or allow the mingling of different lots of shellfish harvested for microbiological cleansing; and no such person shall cause or allow the microbiological cleansing of different lots of shellfish in the same microbiological cleansing tank.
(xxiii) No person engaged in the microbiological cleansing of shellfish shall cause or allow an interchange of water between tanks containing different lots of shellfish unless such water prior to delivery to a successive tank meets the turbidity, salinity, total coliform, temperature and dissolved oxygen requirements of this section.
(xxiv) No person engaged in the microbiological cleansing of shellfish shall fail to tag or label a tank used for such purpose with the lot number and the date and time cleansing began for the shellfish contained in such tank.
(xxv) No person engaged in the microbiological cleansing of shellfish shall fail upon receipt of shellfish harvested for microbiological cleansing to wash such shellfish with water from a source approved by the department, as a permit condition, or fail to discard dead shellfish or shellfish with cracked or broken shells in a manner acceptable to the department.
(xxvi) No person engaged in the microbiological cleansing of shellfish shall fail to place shellfish for microbiological cleansing in containers approved by the commissioner, as a permit condition, prior to engaging in microbiological cleansing. Such contains shall be constructed from safe, easily cleanable materials. Such containers shall be kept non-corroded, cleaned between lots of shellfish and stored in a manner which will prevent the contamination thereof. Such containers shall be constructed in a manner which will permit the free flow of water from all directions.
(xxvii) No person engaged in the microbiological cleansing of shellfish shall fail to place or stack shellfish in three-inch layers or less in containers prior to engaging in microbiological cleansing.
(xxviii) No person engaged in the microbiological cleansing of shellfish shall fail to maintain a 1.5-inch or higher clearance in all directions around containers when such containers are in tanks for microbiological cleansing. The stacking of containers in cleansing tanks is not recommended.
(xxix) No person engaged in the microbiological cleansing of shellfish shall fail to maintain shellfish obtained for such purpose in microbiological cleansing tanks for 48 hours or longer. Such tanks shall be supplied with water at the required flow rate, temperature, dissolved oxygen content, total coliform quality, and salinity for 48 hours or longer.
(xxx) No person engaged in the microbiological cleansing of shellfish shall fail, after the cleansing of a lot of shellfish has been completed, to drain the water from the cleansing tank and dispose of such water in a manner approved by the department as a permit condition.
(xxxi) No person engaged in the microbiological cleansing of shellfish shall fail to clean cleansing tanks after the cleansing of a lot of shellfish. Cleansing tanks shall be washed free of cleaning and/or sanitizing agents before the use of such tanks for microbiological cleansing.
(xxxii) No person engaged in the microbiological cleansing of shellfish shall fail to maintain a working alarm system that will provide a warning of any utility and equipment failure.
(xxxiii) No person engaged in the microbiological cleansing of shellfish shall fail to notify immediately the department of any utility or equipment failure or other difficulty that may prevent or impede the proper microbiological cleansing of shellfish.
(xxxiv) No person engaged in the microbiological cleansing of shellfish shall permit nonmicrobiologically cleansed shellfish to be stored with, transported with, or allowed to come into contact with microbiologically cleansed shellfish and/or shellfish harvested from certified shellfish lands, unless such nonmicrobiologically cleansed shellfish have been harvested from certified shellfish lands.
(xxxv) No person engaged in the microbiological cleansing of shellfish, shall fail, after the microbiological cleansing of a lot of shellfish has been completed, to wash such shellfish with water of drinking water quality, nor fail to discard dead shellfish or shellfish with cracked or broken shells in a manner acceptable to the department.
(xxxvi) No person engaged in the microbiological cleansing of shellfish shall fail to place microbiologically cleansed shellfish in safe containers. Such containers shall have been stored in a manner which will prevent the contamination thereof.
(xxxvii) No person engaged in the microbiological cleansing of shellfish shall sell microbiologically cleansed shellfish unless such shellfish have been cleansed in compliance with the requirements of this section and unless such shellfish will meet the microbiological criteria and other criteria set out as a permit condition in such person's microbiological cleansing operator's permit.
(xxxviii) No person engaged in the microbiological cleansing of shellfish shall sell microbiologically cleansed shellfish unless and until the designated laboratory advises such person that a cleansing water sample has been examined indicating that such shellfish have been microbiologically cleansed for 48 hours or longer in tanks which have received water with a total coliform MPN per 100 milliliters of sample of less than 2.
(xxxix) No person engaged in the microbiological cleansing of shellfish shall fail to dispose of shellfish in a manner approved by the department as a permit condition when the shellfish fail to meet the requirements for microbiological cleansed shellfish set out in this Part or as a permit condition in such person's microbiological cleansing operator's permit.
(2) Microbiological cleansing of soft clams (Mya arenaria).
(i) No person engaged in the microbiological cleansing of soft clams shall fail to use a tank for such purpose which provides at least five cubic feet of usable tank capacity for each bushel of such soft clams being cleansed therein.
(ii) No person engaged in the microbiological cleansing of soft clams shall fail to maintain water in tanks used for such purpose at or between a minimum temperature of 40 degrees Fahrenheit (4.4 degrees Celsius) and a maximum temperature of 68 degrees Fahrenheit (20 degrees Celsius).
(iii) No person engaged in the microbiological cleansing of a lot of soft clams shall sell such a lot of soft clams unless and until the designated laboratory advises such person that such a lot of soft clams, after cleansing for 42 hours or longer, has, for three or more samples of 12 clams each, a median fecal coliform MPN per 100 grams of sample of 50 or lower and no more then 10 percent of the samples have a fecal coliform MPN per 100 grams of sample in excess of 130 when a multiple dilution fermentation tube test is used which examines five 1-gram sample portions, five 0.1-gram sample portions and five 0.01-gram sample portions (or an equivalent test approved by the department as a permit condition).
(3) Microbiological cleansing of hard clams (Mercenaria mercenaria).
(i) No person engaged in the microbiological cleansing of hard clams shall fail to use a tank for such purpose which provides at least eight cubic feet of usable tank capacity for each bushel of such hard clams being cleansed therein.
(ii) No person engaged in the microbiological cleansing of hard clams shall fail to maintain water in tanks used for such purpose at or between a minimum temperature of 53.6 degrees Fahrenheit (12 degrees Celsius) and a maximum temperature of 68 degrees Fahrenheit (20 degrees Celsius).
(iii) No person engaged in the microbiological cleansing of a lot of hard clams shall sell such a lot of hard clams unless and until the designated laboratory advises such person that such a lot of hard clams, after cleansing for 42 hours or longer, has, for three or more samples of 12 clams each, a median fecal coliform MPN per 100 grams of sample of 20 or lower and no more than 10 percent of the samples have a fecal coliform MPN per 100 grams of sample in excess of 70 when a multiple dilution fermentation tube test is used which examines five 1-gram sample portions, five 0.1-gram sample portions and five 0.01-gram sample portions (or an equivalent test approved by the department as a permit condition).
(d) Sealing and tagging or labeling of containers required.
(1) No person engaged in the microbiological cleansing of shellfish shall fail to seal, in a tamper evident manner acceptable to the department, and tag or label containers of such shellfish as soon as possible after the microbiological cleansing of such shellfish has been completed. Such tags or labels shall be in compliance with applicable provisions of section 42.11 of this Part, and such tags or labels shall include the lot number of such microbiologically cleansed shellfish and the words “MICROBIOLOGICALLY CLEANSED.”
(e) Records required to be kept.
(1) No person engaged in the microbiological cleansing of shellfish shall fail to keep complete, accurate and readily available records of all microbiological cleansing sales activities in a permanently bound ledger. Such records shall be in compliance with appropriate provisions of section 42.9 of this Part and such records shall indicate for each lot of shellfish for microbiological cleansing: the lot number, the common name of the shellfish, the quantity (net weight or numerical count or standard measure) of the shellfish received from the harvesters, the names and permit numbers of the harvesters, the name of the waters from which the shellfish were harvested, the quantity (net weight or numerical count or standard measure) of the shellfish sold, the names and permit numbers of the purchasers of the shellfish.
(2) No person engaged in the microbiological cleansing of shellfish shall fail to keep daily dated, accurate and readily available records of microbiological cleansing processing activities in a permanently bound ledger for each lot of shellfish. Such records shall indicate: the lot number, the identification number or letters of each tank used for such purpose, the flow rate in gallons per minute of water supplied to each tank used for such purpose, and the temperature in degrees Fahrenheit or degrees Celsius of the water in each tank used for such purpose.
(3) No person engaged in the microbiological cleansing of shellfish shall fail to keep daily dated records of the hours of operation of the germicidal lamp tubes and/or the ultra-violet light source lamp tubes used for the destruction of microorganisms in the cleansing water.
(f) Special prohibitions.
(1) No person shall fail to redistribute or reship microbiologically cleansed shellfish in the original containers in which such shellfish were received. Such containers shall not be tampered with in any way.
(2) No person engaged in the redistribution or reshipment of containers of microbiologically cleansed shellfish shall remove the original shipper's seal, tag or label from such shellfish containers. Any additional information required by this Part shall be entered on such original shipper's tag.
(3) No person engaged in the redistribution or reshipment of containers of microbiologically cleansed shellfish shall fail to seal in a tamper evident manner acceptable to the department any such containers received from without New York State that are not sealed at the time of receipt.
6 CRR-NY 42.15
Current through October 15, 2021
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