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Part 42: Sanitary Control Over Shellfish

(Statutory authority: Environmental Conservation Law, §§§§ 11-0103, 11-0105, 11-0305, 11-2301, 13-0315, 13-0317, 13-0319; art. 13)

[Last Amended: August 16, 2006]

Contents:

Sec.

§42.1 Intent of this Part

It is the intent of this part to provide adequate sanitary control over all noncommercially sterile shellfish in wholesale commerce in the State of New York.

§42.2 Definitions

Unless the context otherwise requires, the following terms and their derivatives when used in this Part shall have the following meanings:

(a) Aerobic plate count per gram or milliliter means a bacterial test which counts all bacterial colonies which grow in or on standard methods agar when such agar is incubated aerobically for 45 to 51 hours at 35 degrees Celsius plus or minus 0.5 degrees Celsius.

(b) Approved means acceptable to the department based on a determination as to conformance with appropriate standards and/or good public health practices and/or good manufacturing practices.

(c) Batter means any moist edible preparation containing cereal, milk, eggs and other foodstuffs used individually or in combination in the processing of shellfish for use as food for human consumption

(d) Breading means any dry edible preparation containing cereal, milk, eggs and other foodstuffs used individually or in combination in the processing of shellfish for use as food for human consumption.

(e) Certified shellfish lands means shellfish lands from which the harvesting of shellfish for use as food is permitted by commissioner's order.

(f) Clean or cleaned means the absence of foul, loathsome, dangerous, toxic, abnormal, impure or unsafe substance.

(g) Coliform group means all of the aerobic and facultative anaerobic gram-negative, nonspore-forming rod-shaped bacteria which will produce gas from lactose when such lactose is incubated for 51 hours or less at 35 degrees Celsius plus or minus 0.5 degrees Celsius.

(h) Commercial sterility means free of viable microorganisms having public health significance and free of viable microorganisms ordinarily capable of reproducing and causing spoilage under normal storage conditions. Commercial sterility of shellfish or other foodstuffs is achieved by the proper application of heat under pressure or by other effective methods to such shellfish or such other foodstuffs when such shellfish or such other foodstuffs are contained in hermetically sealed containers. Commercially sterile shellfish or other foodstuffs shall not contain viable bacteria of the Coliform group and viable bacteria capable of growing and/or reproducing in or on standard methods agar when such agar is incubated aerobically for 45 to 51 hours at 35 degrees Celsius plus or minus 0.5 degrees Celsius.

(i) Commissioner means the Commissioner of Environmental Conservation or the Commissioner's duly authorized representative.

(j) Container means a receptacle for receiving, shucking, processing, transporting, storing, packing, repacking, shipping or reshipping shellfish.

(k) Contamination means any foul, loathsome, dangerous, toxic or abnormal or impure substance. "Contaminated" means the presence of such substances.

(l) Critical control point means a point, step or procedure in the handling, packing, processing, shipping or shucking of shellfish at which one or more controls can be applied and a food safety hazard can as a result be prevented, eliminated or reduced to acceptable levels.

(m) Critical limit means the maximum or minimum value to which a physical, biological or chemical parameter must be controlled at a critical control point to prevent, eliminate or reduce to an acceptable level the occurrence of the identified food safety hazard or hazards.

(n) Culture or cultivation means the controlled or partially controlled raising, breeding, growing, planting and containment of marine plant or animal life in any marine hatchery or through on-bottom or off-bottom culture.

(o) Department means the State of New York Department of Environmental Conservation.

(p) Easily cleanable means readily accessible and of such material and finish and so fabricated that residues may be completely removed by normal cleaning methods.

(q) Excessive bacteria means, in the case of shellfish, a fecal coliform MPN per 100 grams of sample in excess of 230 and/or an aerobic plate count per gram of sample in excess of 500,000.

(r) Farmed or farm-raised means any shellfish subject to culture or cultivation as permitted under a permit issued by the department pursuant to Part 48 of this Title.

(s) Fecal Coliform means bacteria of the Coliform group which will produce gas from EC medium when such medium is incubated for 26 hours or less at 44.5 degrees Celsius plus or minus 0.2 degrees Celsius in a water bath.

(t) Harvester or digger means a person who takes shellfish from shellfish lands. Harvest means to take shellfish from shellfish lands.

(u) Hazardous means actually or potentially dangerous to human health.

(v) Lot number means the identification number which may be assigned to each day's production of a specific shellfish product when such product is produced in a shellfish processing facility.

(w) Marine district means the waters of the Atlantic Ocean within three nautical miles of the coastline of the state and all tidal waters within the state including the Hudson River up to the Tappan Zee bridge.

(x) Microbiological cleansing means the holding of shellstock in tanks of clean and sanitary water of proper salinity and temperature for the purposes of reducing the numbers of fecal coliform bacteria in such shellstock and otherwise making such shellstock nonhazardous for use as food for human consumption.

(y) MPN means most probable number which is an estimate of the numbers of bacteria per 100 milliliters or grams of sample using laboratory tests and probability tables in a manner endorsed and/or approved by the United States Department of Health and Human Services, Public Health Service, Food and Drug Administration.

(z) Noncommercially sterile means the inverse of commercially sterile.

(aa) Nonhazardous means not actually or potentially dangerous to human health.

(ab) Orderly means the absence of litter, debris, trash, offal or other refuse.

(ac) Original shipper means the first shipper who distributes or sells or offers for sale shellfish to another shipper, reshipper, retailer or ultimate consumer after the harvest of such shellfish or after the purchase of such shellfish from a harvester.

(ad) Packing means placing shellfish in a container. Packer means a person who performs such activities.

(ae) Person means any individual, group of individuals, public or private corporation, industry, copartnership, joint stock company, association, firm, legal entity, trust or estate.

(af) Processing means the shucking, dismembering, cutting, chopping, grinding, heating, freezing, microbiological cleansing, blowing or water storage of shellfish and/or the adding of batter, breading or other foodstuffs to shellfish. Processor means a person who performs such activities.

(ag) Repacking means removing shellfish from a container and placing such shellfish in another container. Repacker means a person who performs such activities.

(ah) Reshipper means a shellfish dealer who receives, and redistributes, in wholesale commerce, previously packed shellfish from a shipper, another reshipper or processor. A reshipper is not authorized to pack, repack, tag or label, retag or relabel containers of shellfish. A reshipper is authorized to remove dead or broken shellfish from containers.

(ai) Retail commerce means the selling or offering for sale of shellfish to the ultimate consumer.

(aj) Safe means nonhazardous.

(ak) Sanitary means free of pathogenic microorganisms and excessive bacteria. Sanitize means to make sanitary.

(al) Sewage means water-borne refuse and/or fecal material of humans and/or other warm blooded animals.

(am) Shellfish means oysters, clams, mussels, or scallops or any edible portion thereof.

(an) Shellfish Dealer means any person who, engages in the processing, packing, repacking, receipt, storage, possession, transportation, distribution or shipment of shellfish

(ao) Shellfish lands means all tidal or saline waters within the marine district and the lands lying thereunder, including such lands which are exposed at low tide.

(ap) Shellstock means shellfish in the shell.

(aq) Shipper means a shellfish dealer who receives shellfish from a harvester, another shipper, a reshipper or a processor and distributes or redistributes shellfish in wholesale commerce.

(ar) Shuck means to release shellfish from one or both shells.

(as) Shucking means the release of shellfish from one or both of the shells.

(at) Stuffing means any edible preparation containing batter, breading, shellfish, seasoning, and other foodstuffs used individually or in combination that may be used in the processing of shellfish as food for human consumption.

(au) Standard measure means a bushel with a volume of 2150.42 cubic inches or otherwise in agreement with the criteria set out in the Agriculture and Markets Law, Article 16, section 176.

(av) Total coliform means bacteria of the coliform group which will produce gas from brilliant green bile lactose broth two percent when such broth is incubated for 51 hours or less at 35 degrees Celsius plus or minus 0.5 degrees Celsius.

(aw) Uncertified shellfish lands means shellfish lands from which, except as otherwise provided pursuant to the Environmental Conservation Law or this subchapter, the harvesting of shellfish for use as food has been prohibited by commissioner's order.

(ax) Unsafe means the inverse of safe.

(ay) Water of drinking quality means water that meets the requirements of Title 10 of the Official Compilations of code, Rules and Regulations, Parts 5 and 72.

(az) Water storage means the holding of shellstock harvested from certified shellfish lands in tanks of water for purposes of storage and/or desanding.

(ba) Wholesale commerce means the selling or offering for sale of shellfish, to a person other than the ultimate consumer, and such shellfishing activities as the harvesting, processing, packing, repacking, receiving, storing, possessing, shipping or reshipping of shellfish which may result in such selling or offering for sale.

(bb) Wild means any marine plant or animal life existing in a wild or natural state that are not subject to culture or cultivation under a permit issued by the department pursuant to Part 48 of this Title.

§42.3 Applicability; general prohibitions

(a) The provisions of this Part shall apply to all persons who, in wholesale commerce, engage in any aspect of shellfishing in the State of New York including, but not limited to, the growing, harvesting, processing, handling, microbiological cleansing, packing, repacking, receiving, storing, possessing, transporting, distribution, shipping, reshipping and/or selling or offering for sale of shellfish.

(b) Failure to comply with the provisions this Part or the conditions of any permit issued pursuant to this Part is a violation of this Part.

(c) Nothing contained in this Part shall be construed as relieving any person from complying with any applicable Federal, State or local law or rule or regulation.

(d) Nothing contained in this Part shall be construed as preventing the department from inspecting retailers and/or other nonpermit holders to insure compliance with applicable provisions of article 13 of the Environmental Conservation Law and this Part, when the department deems that such inspections may be necessary to assure that the public health, safety and welfare of the people of the State of New York are protected and the intent and purposes of article 13 of the Environmental Conservation and this Part will be carried out.

(e) No person engaged in any activity described in this Part shall purchase or receive shellfish from a person who has failed to obtain and maintain a valid and appropriate permit issued by the department or a similar valid permit issued by the shellfish sanitation control agency of the exporting state or foreign country. In order for such permit to be acceptable to the department, the shellfish sanitation control program of such state or foreign country shall have been endorsed and/or approved by the United States Department of Health and Human Services, Public Health Service, Food and Drug Administration.

(f) No person shall import into the State of New York shellfish for use as food for human consumption unless such shellfish have been grown, harvested, processed, stored, packed, repacked, shipped, reshipped, as appropriate, under sanitary conditions which are in substantial compliance with the provisions of this Part.

§42.4 Applications for permits; permit descriptions; permit fees

(a) No person shall engage in any activity described in this Part without a valid and appropriate permit issued by the department.

(b) An application for a permit shall be filed by the applicant with the State of New York Department of Environmental Conservation, Division of Fish, Wildlife and Marine Resources, Marine Permit Office, on a form and in a manner prescribed by the department. An application shall be accompanied by the appropriate permit application fee as set out in article 13 of the Environmental Conservation Law.

(c) Subject to the provisions of sections 13-0311 and 13-0315 of the Environmental Conservation Law and this Part, the department in its discretion may issue permits for the following shellfishing activities:

(1) digger's (harvester's) permit. This permit allows the holder thereof to take (harvest) shellfish from certified shellfish lands in the State for commercial purposes and to ship or sell such shellfish only to a holder of a valid class A, B, or E shipper's permit, who has a place of business in Nassau or Suffolk counties;

(2) class A (shipper) permit. This permit shall allow the holder thereof and any person in the employ of the permit holder to: (i) reship shellfish previously shipped by the holder of a class A, B, C, D or E permit, or similar permit issued by the shellfish sanitation control agency of another state or foreign country; (ii) pack or repack shellstock received from the holder of a digger's permit; or (iii) pack or repack shellstock received from the holder of a class A, B, C, D, or E permit, or similar permit issued by the shellfish sanitation control agency of another state or foreign country; the holder of a class A permit is authorized to tag or label, retag or relabel containers of shellstock;

(3) class B (processor) permit. This permit shall allow the holder thereof and any person in the employ of the permit holder to engage in the activities authorized by a class A permit, as described in paragraph (2) of this section, and to otherwise process shellfish;

(4) class C (reshipper) permit. This permit shall allow the holder thereof and any person in the employ of the permit holder to reship shellfish previously shipped by the holder of a class A, B, C, D or E permit or similar permit issued by the shellfish sanitation control agency of another state or foreign country. The holder of a class C permit is authorized to remove dead or broken shellstock from containers, but is not authorized to pack, repack, tag or label, retag or relabel containers of shellfish;

(5) class D (digger/shipper) permit. This permit shall allow the holder thereof to ship shellstock which the holder has legally harvested from shellfish lands of the state;

(6) class E ( bay scallop shucker/packer) permit. This permit shall allow the holder thereof, members of his immediate family, and not more than two employees of the permit holder to shuck and pack bay scallops which have been received from the holder of a digger's permit and to ship such scallops in the form of fresh shucked stock only in intrastate commerce;

(7) shellfish bait harvester's permit- no fee. This permit shall allow the holder thereof to harvest shellfish from designated uncertified shellfish lands and to use or sell such shellfish for bait purposes only;

(8) shellfish microbiological cleansing-principal harvester's permit-no fee. This permit shall allow the holder thereof to undertake a project for harvest of shellstock from uncertified shellfish lands including the transport and sale of such shellstock to a designated shellfish microbiological cleansing facility only;

(9) shellfish microbiological cleansing-harvester's permit-no fee. This permit shall allow the holder thereof to harvest shellstock from designated uncertified shellfish lands and to transport and/or sell such shellstock to a designated shellfish microbiological cleansing facility only;

(10) shellfish water storage permit-no fee. This permit shall allow the holder thereof to store shellstock harvested from certified shellfish lands in tanks of water; and

(11) shellfish microbiological cleansing operator's permit-no fee. This permit shall allow the holder thereof to operate a facility for the microbiological cleansing of shellfish.

§42.5 Conditions of a permit

(a) Any permit issued pursuant to article 13 of the Environmental Conservation Law or this Part may be issued with conditions. Conditions may be attached as may be necessary to assure that the public health, safety and welfare of the people of the State of New York are protected and that the intent and purposes of this Part will be carried out. Facilities, buildings, structures, equipment and conveyances used for activities described in this Part shall be in compliance with the applicable provisions of this Part and shall be approved by the department prior to the issuance of a permit.

(b) Every permit issued pursuant to article 13 of the Environmental Conservation Law or this Part shall contain the following conditions:

(1) the department shall have the right to inspect any facility, building, structure, property or conveyance used for any activity described in this Part;

(2) the department shall have the right to take samples, without payment, of any shellfish, water, chemicals, food ingredients and other substances for examinations;

(3) the department shall have the right to inspect and/or copy any hazard analysis and hazard control plans, hazard control plan records, sanitation records, tags, labels, shipping or receiving invoices, bills of lading or other records required to be kept pursuant to this Part;

(4) the permit shall expire on December 31st of the year of issue;

(5) the violation of any condition of a permit or provision of this Part may result in permit modification, suspension, or revocation and/or seizure of any lot, quantity or shipment of shellfish and /or related materials associated with such violation; and

(6) the permit shall be made available for inspection by the department at all times from the date of issue through the date of expiration and during conducting of any activity described in this Part.

(c) The holder of a class A, B, C, or D permit, issued pursuant to Section 42.4 of this Part, shall not ship shellfish out of state unless such permit contains a condition authorizing them to do so.

(d) The holder of a class A, B or E permit, issued pursuant to Section 42.4 of this Part, shall not purchase or otherwise receive shellstock from the holder of a digger's permit, unless such class A, B or E permit holder has a place of business in Nassau and/or Suffolk Counties and such permit contains a condition authorizing them to do so.

§42.6 License or permit revocations

The revocation of licenses or permits issued pursuant to this Part will be pursuant to the provisions of Part 175 of this Title.

§42.7 Record keeping requirements

(a) General prohibitions.

(1) No person shall fail to maintain complete and accurate records of all shellfish transactions sufficient to include all required information.

(2) No person shall fail to make records of all shellfish transactions available for inspection for a period of at least two years for frozen shellfish and one year for fresh shellfish from the date of the last entry.

(3) No processor shall fail to assign and include lot numbers in records for specific batches of shellfish processed when deemed appropriate by the department, as a permit condition.

(b) Harvesters (diggers). No harvester (digger) shall fail to make daily dated entries in a ledger or using other methods approved by the department indicating quantities (net weights or numerical counts or standard measures) of shellfish harvested, the harvest date, an identification of the areas from which the shellfish were harvested, and the names and permit numbers of all purchasers of shellfish.

(c) Dealers.

(1) HACCP (Hazard Analysis Critical Control Point); hazard analysis and hazard control plan.

(i) No shellfish dealer shall fail to conduct, or have conducted for their facility and operations, a hazard analysis to determine whether a food safety hazard is reasonably likely to exist for each shellfish product that they shuck, process, pack, repack, ship or reship and maintain a written record of the date and findings of such hazard analysis. The analysis shall identify the preventive measures that shall be implemented at critical control points to reduce or eliminate the food safety hazards. Such hazards may be introduced within or outside the permit holder's facility and include food safety hazards that can occur before, during and after harvest.

(ii) No shellfish dealer shall fail to have and implement a written hazard control plan when a hazard analysis determines that one or more food safety hazards are reasonably likely to occur. The written hazard analysis and control plan shall be specific to the permit holder's facility, operations and all shellfish products handled at that facility, any off-site storage area, or any means of conveyance used by the permit holder to transport shellfish. The hazard control plan shall identify the food safety hazards, critical control points, critical limits and preventive measures the permit holder or the most responsible person at the facility shall take to control, reduce or eliminate those hazards. The hazard analysis and hazard control plan shall be dated and signed by one of the following individuals: the most responsible person at the permit holder's facility, a higher level official of the firm, or by the permit holder. That person's signature shall signify that the hazard analysis and written hazard control plan have been accepted by the permit holder for implementation at the permit holder's facility, any off-site storage area(s) or any means of conveyance used by the permit holder to transport shellfish.

(iii) No shellfish dealer shall fail to provide and accurately maintain orderly dated records that document routine monitoring of the critical control points and critical limits identified in the hazard analysis and written hazard control plan. The records shall include the actual values obtained and observations made during the monitoring of critical control points and critical limits.

(2) Sanitation Monitoring.

(i) No shellfish dealer shall fail to maintain orderly dated sanitation records. Such records shall accurately document the frequency of sanitation control practices and the correction of any insanitary conditions to ensure that the permit holder's facility or off-site storage area(s) or any means of conveyance used by the permit holder to transport shellfish is kept in an orderly, nonhazardous condition and that all the shellfish products in the permit holder's facility, off-site storage area(s) or any means of conveyance used by the permit holder, are shucked, processed, packed, repacked, shipped or reshipped in a safe and sanitary manner. Such sanitation practices and sanitation records shall, at a minimum, address the following:

(a) safety of water that comes in contact with food or food contact surfaces;

(b) condition and cleanliness of food contact surfaces, utensils, gloves and outer garments;

(c) prevention of cross-contamination from insanitary objects or materials to shellfish products, shellfish packaging materials, food contact surfaces, utensils, gloves and outer garments;

(d) maintenance of hand washing, hand sanitizing and toilet facilities;

(e) protection of shellfish products, shellfish packaging materials, food contact surfaces, utensils, gloves and outer garments from adulteration with cleaning compounds, sanitizing agents, lubricants, condensate, pesticides, and other physical, chemical and biological contaminants;

(f) proper labeling, storage and use of cleaning compounds, sanitizing agents or other toxic materials;

(g) monitoring and control of employees' health conditions that could result in microbiological contamination of shellfish, shellfish packaging, materials, food contact surfaces, utensils, gloves and outer garments; and

(h) exclusion of vermin, insects, other pests and domestic animals from the permit holder's facility, any off-site storage area(s) and any means of conveyance used by the permit holder to transport shellfish.

(3) Receiving records.

(i) No shellfish dealer shall fail to maintain receiving records that include the following:

(a) the names, addresses and permit numbers of all shellfish dealers from whom shellfish were received;

(b) the names and state permit numbers of harvesters if shellfish are received from harvesters;

(c) the date received;

(d) the date of harvest;

(e) the quantities (net weights or numerical counts or standard measures) of shellfish received;

(f) the common name of the shellfish received;

(g) area of harvest;

(h) wild or farm-raised;

(i) the on/off-bottom culture permit number for farm-raised shellfish; and

(j) the original shipper's permit number.

(ii) No shellfish dealer shall receive a shipment of shellfish unless it is accurately identified by an invoice or bill of lading nor fail to make any such invoice or bill of lading received with shellfish readily available for inspection by the department for at least one year after the receipt of such shellfish. Such invoices or bills of lading shall include the name, address and state shellfish permit number of the dealer, the date the shipment was received, quantity and common name of all shellfish in the shipment. If such invoices or bills of lading are maintained by the dealer as the receiving record, the area of harvest, original shipper permit number and harvest date must be included. No dealer shall fail to file such invoices or bills of lading in an orderly manner by date or by other methods acceptable to the department.

(4) Shipping records.

(i) No shellfish dealer shall fail to maintain shipping records that include the following:

(a) the recipient's name;

(b) the quantities (net weights or numerical counts or standard measures) of shellfish shipped;

(c) the common name of the shellfish shipped;

(d) wild or farm-raised;

(e) the on/off-bottom culture permit number for farm-raised shellfish;

(f) date shipped;

(g) area of harvest;

(h) harvest date;

(i) the original shipper permit number; such permit numbers shall be prefixed with the initials of the state or foreign country issuing such permit.

(ii) No shellfish dealer shall ship shellfish unless it is accompanied by an invoice or bill of lading nor fail to make one copy of any invoice or bill of lading for shipped shellfish readily available for inspection by the department for at least one year after the sale of such shellfish. Such invoices or bills of lading shall be preprinted or stamped with the seller's name, business address and state shellfish permit number and must clearly indicate the name and permit number, if applicable, of the receiver of the shellfish, the quantity (net weight, numerical count or standard measure) and common name of the shellfish shipped, the date shipped and the area of harvest. If such invoices or bills of lading are maintained by the dealer as the shipping record, the original shipper permit number and harvest date must be included. No dealer shall fail to file such invoices or bills of lading in an orderly manner by date or by other methods acceptable to the department.

(iii)No shellfish dealer possessing a valid class A, B, D, or E shipper's permit issued by the department shall fail to make entries in such a ledger indicating monthly totals of quantities (net weights or numerical counts or standard measures) and common names of all shellfish received from harvesters or sold in such month and an identification of the waters from which the shellfish were harvested; nor fail to report such monthly totals to the Shellfisheries Section, Division of Fish, Wildlife and Marine Resources, State of New York Department of Environmental Conservation by the 10th day of each succeeding month.

§42.8 Facilities, buildings, structures and surrounding grounds

(a) No person shall use or construct a new facility, building or structure, nor alter an existing facility, building or structure, for the receiving, packing, processing, storage or handling of shellfish unless it is approved by the department.

(b) No person shall use a facility, building or structure unless it is of such a size that work can be carried out in an orderly and sanitary manner.

(c) No person shall fail to keep a facility, building or structure clean, orderly and in good repair.

(d) No person shall allow access to operational areas of a facility, building or structure to unauthorized persons or employees.

(e) No person shall use a facility, building or structure unless unused or non essential equipment is stored in areas where shellfish activities are not conducted or is removed from the premises.

(f) No person shall use a facility building or structure that is subject to flooding during ordinary high tides.

(g) No person shall use a facility, building or structure that becomes flooded.

(1) All shellfish activities shall be discontinued immediately and resumed only after the flood waters have receded.

(2) The facility, building or structure shall be cleaned and sanitized before shellfish operations can resume.

(3) Any shellfish related equipment shall be cleaned and sanitized before it can be used.

(4) Any shellfish packaging materials that have come into contact with flood waters must be adequately disposed of.

(h) No person shall use a facility, building or structure that does not have adequate drainage in parking areas, driveways and surrounding grounds.

(i) No person shall fail to provide adequate control of insects, vermin, birds, wild and domestic animals.

(1) A facility, building or structure shall be constructed to prevent insects, vermin, birds, wild and domestic animals from entering the premises.

(2) Openable exterior windows shall be effectively screened, or otherwise protected.

(3) Exterior doors shall be solid, tight fitting, self closing and kept in proper working condition; air screens or similar exclusion devices may be used and shall be kept in proper working condition.

(4) Other potential entrance places such as around chimneys, vent pipes and heating or cooling duct work shall be screened or otherwise protected.

(5) Exterior waste disposal receptacles shall have closeable lids that prevent the entrance of insects and vermin, birds, wild and domestic animals.

(6) Areas surrounding a facility, building or structure shall be free from conditions which may attract insects and vermin, birds, wild and domestic animals.

(j) No person shall use a facility, building or structure that does not have adequately constructed walls, ceilings and floors.

(1) Walls shall be covered with smooth, impervious, light-colored material.

(2) Ceilings shall be covered with smooth, light-colored material.

(3) Floors shall be constructed of smooth, impervious, materials, graded to effectively drain and maintained to be free from cracks or uneven surfaces that prevent proper drainage and cleaning.

(4) Floor drains shall be located within the facility, building or structure, effectively prevent the backflow of waste waters and odors and be connected to an acceptable disposal system that complies with applicable plumbing codes.

(5) Junctions between floors and walls shall be sealed and impervious.

(k) No person shall use a facility, building or structure that does not have adequate lighting sufficient to observe all areas.

(1) In areas where shellfish are received, handled, packed, repacked, processed or stored, light bulbs, tubes and other sources of illumination shall be shielded, coated or otherwise shatter resistant.

(l) No person shall use a facility, building or structure unless an adequate number of refuse containers are provided within the facility. Such containers shall be maintained in good condition and emptied regularly throughout the work day.

(m) No person shall fail to store, cleaning compounds, sanitizers, pesticides, other chemicals and other potentially unsafe substances in areas separated from shellfish storage and shellfish related activities.

(n) Shellfish receiving, packing, repacking and processing areas.

(1) No person shall receive, handle, pack, repack and/or process shellfish in unapproved areas of a facility, building or structure.

(2) No person shall use an area of a facility, building or structure to receive, handle, pack, repack and/or process shellfish unless it meets the requirements in Subdivisions (a) through (m) of this Section.

(o) Shellfish Microbiological Cleansing facilities.

(1) No person shall microbiologically cleanse shellfish in unapproved areas of a facility, building or structure.

(2) No person shall use an area of a facility, building or structure to microbiologically cleanse shellfish unless it meets the requirements in Subdivisions (a) through (m) of this Section.

§42.9 Safety of water and ice

(a) Water supply.

(1) No person shall fail to provide a water supply that is of drinking water quality.

(2) No person shall use a facility, building or structure which does not have a permanently installed supply of hot water and cold running water, of drinking water quality.

(3) No person shall use a water supply that is not protected from backflow.

(4) No person shall use a water supply unless it is protected from cross connections with waste water and/or sewage.

(5) No person shall fail to have water from non public water systems or private wells tested by an approved laboratory prior to use, after it has been repaired and at least two (2) times a year.

(b) Ice.

(1) No person using ice as a refrigerant shall fail to make such ice from water of drinking water quality or use ice from an approved source.

(2) No person shall fail to store and handle such ice in a manner which will prevent the contamination thereof.

(3)No person shall fail to store ice in areas that are equipped with drains adequate to prevent the accumulation of water created by melting ice.

(4) No person using ice for a refrigerant shall fail to use shovels, scoops, pails, buckets and other equipment for the handling of ice which have been constructed from safe materials, kept non corroded, clean, sanitary and stored in a manner which will prevent the contamination thereof.

§42.10 Plumbing, sewage, wastewater, hand washing sinks, toilets and toilet rooms

(a) No person shall fail to permanently install plumbing in compliance with applicable plumbing codes.

(b) No person shall fail to provide an easily accessible and permanently installed hand washing sink with the following:

(1) Warm water at a minimum temperature of at least 100 degrees Fahrenheit (37.8 degrees Celsius) dispensed from a hot and cold mixing or combination faucet;

(2) Permanently installed drains that are connected to effective and appropriate waste disposal areas;

(3) Adequate supplies of hand-cleaning liquid or powdered soap or detergent in suitable containers;

(4) Adequate supplies of single-service sanitary towels or approved mechanical hand drying devices; and

(5) Highly visible and understandable signs directing workers and/or employees to wash their hands thoroughly with soap or detergent before starting work and before returning to work after any interruption; and

(6) Refuse containers are provided at hand washing sink locations.

(c) No person shall fail to provide a safe and effective means for the disposal of sewage and other waste waters that complies with applicable plumbing and building codes.

(d) Toilets and toilet rooms.

(1) No person shall fail to provide convenient access to a toilet room that has an adequate number of toilets.

(i) Toilet room doors shall be tight fitting, self closing and do not open directly into the packing room of a shucking packing or repacking facility.

(ii) Toilet rooms shall have adequate ventilation that meets applicable building code requirements.

(iii) A supply of toilet tissue shall be provided in the toilet room.

(iv) A hand washing sink that complies with the requirements in Subdivision (b) Paragraphs (1-6) of this Section shall be provided in or adjacent to the toilet room.

(v) Refuse containers shall be provided in or adjacent to the toilet room.

§42.11 Receiving, packing, repacking and processing shellfish

(a) Identification of shellfish by shellfish dealers.

(1) General Requirements.

(i) No person, including retailers, shall receive, store, possess, sell, offer for sale, transport, ship, reship or caused to be received, stored, possessed, sold, offered for sale, transported, shipped or reshipped, shellfish in containers that have not been properly tagged and/or labeled.

(ii) Except as provided in subparagraph (iii) of this paragraph or this Part, no person, including retailers, shall remove or deface any tag and/or label required to be affixed to any container pursuant to this Part.

(iii) No person, including retailers, shall fail to retain any tag and/or label required to be affixed to any container pursuant to this Part when such container is emptied or from which the tag and/or label is legally removed upon retagging or relabeling and such tags and/or labels shall be available for inspection by the department for a period of 90 days from the date such tag and/or label is removed. Such tags shall be retained in an orderly manner by date.

(iv) No person, including retailers, shall receive, purchase, possess, sell, offer for sale, give or cause to be received, purchased, possessed, sold, offered for sale or given, any shellfish tag or label that belongs to another shipper, except the tag or label that is required to be affixed to each container of shellfish pursuant to this Part.

(2) Commingling of shellfish.

(i) No person shall pack shellfish from more than one shipper or more than one harvest area, as described in section 42.13(d) of this Part or from different harvest areas without the State, in the same container.

(ii) No person shall pack or repack shellfish that have been cultured or farm-raised from more than one culture or cultivation site or from more than one on/off-bottom culture permit holder within the State, in the same container.

(iii) No person shall pack or repack shellfish that have been cultured or farm-raised in the same container with wild shellfish that are taken from any cultivation site or harvest area within the State.

(iv) Shucked scallops from any harvest area described in section 42.13(d) of this Part may be packed together.

(v) By written request to the department, shippers who purchase shellfish from harvesters may define a harvest area. Such harvest areas may combine no more than two adjacent harvest areas. Requests must be addressed to the Bureau of Marine Resources, Shellfish Section, New York State Department of Environmental Conservation.

(3) Shellstock Identification.

(i) Shellfish dealer tags shall meet the requirements.

(a) The Shellfish tag shall be at least 2 5/8 inches wide and 5 1/4 inches long, constructed of a substantial, waterproof and tear-resistant material with a reinforced point of attachment.

(b) All the information on a shellfish tag must be indelible and legible.

(c)The information in subclauses (1) through (9) below must be in the specific order as follows:

(1)shipper's name;

(2)shipper's address;

(3)shipper's permit number with the prefix "NY" and followed by a two-letter shipper designation assigned by the department, either preprinted or stamped;

(4) a place for the original shipper's permit number if different;

(5) harvest date with the shipping date next to the harvest date;

(6) harvest area, including state of origin. (The description of the harvest area for shellfish harvested in New York State must not be less specific than the descriptions set out in section 42.13 (d) of this Part; out-of-state harvest areas must be identified by the official or common name);

(7) common name of the shellfish in the container;

(8) the net weight or numerical count or standard measure of the shellfish in the container; and

(9) the following preprinted statement in bold, capitalized type: "THIS TAG IS REQUIRED TO BE ATTACHED UNTIL THE CONTAINER IS EMPTY OR RETAGGED AND THEREAFTER KEPT ON FILE FOR 90 DAYS."

(d) The following indelible statement, or an equivalent statement, shall appear on one side of the tag: "RETAILERS, INFORM YOUR CUSTOMERS: Consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase your risk of foodborne illness, especially if you have certain medical conditions."

(e) No person shall fail to describe the areas from which shellfish were harvested. The description of areas for shellfish harvested in New York State shall not be less specific than the descriptions set out in section 42.13 (d) of this Part. Out-of-state harvest areas shall be identified by the official or common name of the embayment or body of water.

(f) No person shall fail to indicate whether the shellfish are wild or farm-raised.

(g) No person shall fail to include the on/off-bottom culture permit number for shellfish cultured within the State.

(ii) Original shippers and packers

(a) No original shipper or repacker of shellstock shall fail to tag shellfish in compliance with Paragraph (1) of this section.

(b) An original shipper or packer must remove harvesters' tags from containers of shellfish, and keep them on file in an orderly manner for 90 days; except when the tag is required to remain attached.

(4) Processed shellfish identification.

(i) Packers and repackers of processed shellfish.

(a) No packer or repacker of shucked shellfish shall fail to pack such shellfish or portions thereof, in clean and sanitary containers which have been clearly and permanently marked with the packer's and/or the repacker's name, the packer's and /or repackers permit number prefixed with the initials of the state or foreign country that issued the permit, the date such shellfish were shucked, the common name of the shellfish contained in then container, and the net weight or numerical count, or standard measure of the shellfish contained in the container. The date shucked shall appear on the lid and the side wall or bottom of the container. The date shall appear in a format which identifies the day, month and year the product was shucked.

(b) No packer or repacker of processed shellfish shall fail to pack such shellfish, or portions thereof, in clean and sanitary containers which have been clearly and permanently labeled with a lot number when the department determines, as a permit condition, that such labeling with a lot number is necessary.

(c) The labels on containers described in Clauses (a) and (b) of Subparagraph (i) may also include a name and/or address prefaced with either "distributed by" or "packed for." In such case only the packer's or repacker's permit number need be included on the labels.

(b) Receiving, packing and repacking operations for shellstock.

(1) No person shall fail to provide for the competent supervision of workers and/or employees to insure shellstock are not contaminated when received, packed, repacked or otherwise handled.

(2) No person shall fail to receive shellfish that is not reasonably free of mud, sand, clay and other sediment.

(3) No person shall fail to discard dead shellfish or shellfish with cracked or broken shells.

(4) No person shall fail to place shellstock received from a harvester under temperature control within two hours from the time of receipt.

(5) No person shall fail to keep shellstock received from a shellfish dealer under temperature control.

(6) No person shall fail to keep shellstock under temperature control except for brief periods not to exceed two hours to allow for the loading, unloading, culling, packing and repacking of shellstock.

(7) No person shall fail to store shellstock in safe containers. Such containers shall be stored in a manner which will prevent the contamination thereof.

(8) No person shall fail to use equipment for the receiving, packing, repacking or otherwise handling of shellstock that is constructed from easily cleanable, corrosion resistant, impervious materials.

(9) No person shall fail to maintain and clean equipment used for the receiving, packing, repacking or otherwise handling of shellstock.

(10) No person shall place, store or allow to be placed or stored, shellstock directly on a floor, the ground, street, sidewalk, curb or any other possibly contaminated surface. This may be accomplished by the use of impervious and easily cleanable pallets, racks or other effective devices. Such pallets, racks or other effective devices shall be washed frequently to maintain cleanliness.

(11) No person shall fail to use running water from an approved source to wash shellstock.

(12) No person shall fail to provide adequate cleaning supplies, brushes, detergents and sanitizers.

(c) Shucking and the processing, packing and repacking of shucked shellfish.

(1) Equipment.

(i) No person shall fail to use equipment for the shucking, processing, packing and repacking of shellfish, unless the food contact surfaces of such equipment are constructed from safe, easily cleanable, water impervious, food grade materials that are free from exposed screws, bolts and rivet heads.

(ii) No person shall fail to use equipment for the shucking, processing, packing and repacking of shellfish unless such equipment is non-corroded, clean and sanitary.

(iii) No person shall use shucking benches and blocks unless the food contact surfaces of such shucking benches and blocks are constructed from safe, easily cleanable, smooth and water impervious materials. Clothing, supplies and other materials shall not be stored above such shucking benches.

(iv) No person shall use machines for shucking, grinding, mincing, blowing, washing or other shellfish processing operations unless such machines are constructed from safe, easily cleanable materials. Such machines shall be cleaned frequently during the work day and at the end of the work day.

(v) No person shall fail to install and maintain effective air filters on all blower air pump intakes and no person shall install oil bath type filters on such blower are pump intakes.

(vi) No person shall use tools, knives, buckets and other utensils for the shucking, processing, packing and repacking of shellfish unless such tools, knives, buckets and other utensils are constructed from safe, easily cleanable, water impervious, food grade materials that are free from exposed screws, bolts, and rivet heads.

(vii) No person shall use tools, knives, buckets and other utensils for the shucking, processing, packing and repacking of shellfish unless such equipment is non-corroded, clean and sanitary.

(viii) No person shall fail to frequently clean tools, knives, buckets and other utensils during the working day. At the end of the working day tools, knives, buckets and other utensils shall be stored and maintained in a manner that will prevent contamination.

(ix) No person shall fail to provide a test kit or other device that accurately measures the concentration of chemical sanitizing agents.

(x) No person shall fail to wash and sanitize their hands, gloves, tools, knives, buckets and other utensils with an effective disinfecting solution.

(xi) No person shall use shucking buckets or other containers which receive shucked shellfish, or portions thereof, when such buckets or containers have been nested, unless exteriors of such buckets or containers have been sanitized before nesting.

(xii) No person shall fail to provide a permanently installed three compartment sink for the washing, rinsing and sanitizing of equipment with the following:

(a) Hot and cold water;

(b) Combination faucets or faucets with mixing valves;

(c) Permanently installed drains that are connected to effective and appropriate waste disposal areas; and

(d) Adequate supplies of detergent and sanitizers in suitable containers convenient to the sink area.

(xiii) No person shall fail to provide an easily accessible and permanently installed hand washing sink in the packing area with the following:

(a) Warm water at a minimum temperature of at least 100 degrees Fahrenheit (37.8 degrees Celsius) dispensed from a hot and cold mixing or combination faucet;

(b) Permanently installed drains that are connected to effective and appropriate waste disposal areas;

(c) Adequate supplies of hand-cleaning liquid or powdered soap or detergent in suitable containers;

(d) Adequate supplies of single-service sanitary towels or approved mechanical hand drying devices;

(e) Highly visible and understandable signs directing workers and/or employees to wash their hands thoroughly with soap or detergent before starting work and before returning to work after any interruption; and

(f) Refuse containers are provided at hand washing sink locations.

(xiv) No person shall fail to provide adequate cleaning supplies, brushes, detergents, sanitizers.

(2) Operations.

(i) No person shall fail to shuck, process, pack or repack shellfish in a manner which will prevent the development of excessive bacteria in such shellfish.

(ii) No person shall fail to separate operations such as shucking, packing and other operations by partitions or other effective methods, when the department determines, as a permit condition, that such separations of such operations as, shucking, packing and other operations are necessary.

(iii) No person shall fail to cool shellfish to 45 degrees Fahrenheit (7.2 degrees Celsius) within two hours after shucking, and no person shall fail to maintain such shucked shellfish, or portions thereof, at between 33 degrees Fahrenheit (0.55 degrees Celsius) and 45 degrees Fahrenheit (7.2 degrees Celsius) unless such shellfish, or portions thereof, are frozen and maintained at zero degrees Fahrenheit (-17.8 degrees Celsius) or lower.

(iv) No person shall fail to remove shellfish shells from shucking operation areas frequently during the working day and at the end of the working day.

(v) No person shall fail to shuck, process, pack or repack shellfish in clean and sanitary containers, and no person shall fail to protect such containers from contamination and store such containers in a manner that will prevent the contamination thereof.

(vi) No person shall use breading, batter, stuffing or similar materials unless such breading, batter, stuffing or similar materials are prepared from safe ingredients in a clean and sanitary manner. Such breading, batter, stuffing or similar materials shall be protected from contamination and shall be prepared fresh daily in reasonably small quantities, and shall be maintained between 33 degrees Fahrenheit (0.55 degrees Celsius) and 45 degrees Fahrenheit (7.2 degrees Celsius).

(3) Supervision and Personnel.

(i) No person shall fail to provide supervision of workers and/or employees to insure that such workers and/or employees do not contaminate shellfish.

(ii) No person shall fail to maintain a high standard of personal cleanliness.

(iii) No person shall fail to wear clean aprons or coats or uniforms as outer garments.

(iv) No person shall fail to wash his or her hands and/or gloves before starting work and after each absence from his work station and before changing his work station, and whenever his or her hands and/or gloves might have become soiled or contaminated.

(v) No person shall use gloves, finger cots or shields which have been made from absorbent material.

(vi) No person shall fail to remove jewelry from his/her hands or wrists.

(vii) No person shall fail to wear effective hair restraints.

(viii) No person shall store clothing or other personal belongings in areas where shellfish are shucked and processed, packed and/or repacked.

(ix) No person shall eat food, drink beverages or use tobacco in any form in areas where shucked shellfish or portions thereof, or shellfish ingredients are exposed.

(x) No person affected by disease in a communicable form or while a carrier of such disease or while affected by boils, sores, infected wounds or abnormal sources of microbiological contamination shall work in any capacity in a facility, building or structure in which there is reasonable possibility of shellfish or shellfish ingredients becoming contaminated by such person or of a disease being transmitted by such person to other individuals.

§42.12 Storage of Shellfish

(a) Shellfish dry storage.

(1) No holder of a shellfish shipper's permit shall fail to provide a designated area for the dry storage of shellfish that complies with the requirements of this subdivision.

(i) No person shall fail to separate dry storage areas and activities from other facilities and activities by means of partitions or other effective methods.

(ii) No person shall allow, during the duration of the term of the applicable permit, the use of a dry storage area for any purpose other than the dry storage of foodstuffs.

(iii) No person shall fail to provide a dry storage area with light bulbs, tubes and other sources of illumination that are shielded, coated or otherwise shatter resistant.

(iv) No person shall operate a dry storage area that is not of sufficient size to permit the inspection of contents, adequate air circulation and work space for employees.

(v) The floors shall be constructed of smooth, water-impervious materials and are graded to effective drains or outlets that provide rapid drainage of waste waters to effective and appropriate waste water disposal areas.

(vi) The walls shall be covered with impervious, smooth and light-colored materials.

(vii) The ceilings shall be covered with smooth, impervious light-colored materials.

(viii) The junction between floors and walls shall be sealed and impervious.

(ix) The dry storage area shall be equipped with automatic temperature controls capable of continuously maintaining the temperature between 33 degrees Fahrenheit (0.55 degrees Celsius) and 45 degrees Fahrenheit (7.2 degrees Celsius).

(x) The dry storage area shall be equipped with an accurate (± 2 degrees Fahrenheit) readily visible thermometer or an accurate (± 2 degrees Fahrenheit) temperature recording device.

(xi) The dry storage area shall be washable throughout, kept orderly, in good repair, protected from insects, vermin, domestic animals and other agents and forms of potential contamination.

(xii) Shellfish shall not be placed, stored or allowed to be placed or stored directly on the floor or any other possible contaminated surface. This may be accomplished by the use of impervious, easily cleanable pallets, racks or other effective devices. Such pallets, racks or other effective devices shall be washed frequently to maintain cleanliness.

(xiii) Frozen shellfish shall be maintained at 0 degrees Fahrenheit (-17.8 degrees Celsius) or lower.

(xiv) Unfrozen shucked shellfish or unfrozen portions shall be maintained between 33 degrees Fahrenheit (0.55 degrees Celsius) and 45 degrees Fahrenheit (7.2 degrees Celsius).

(xv) Unfrozen shellstock shall be maintained between 33 degrees Fahrenheit (0.55 degrees Celsius) and 50 degrees Fahrenheit (10 degrees Celsius).

(b) Wet Storage.

(1) The provisions of this section shall apply to any person storing or responsible for the storage of shellfish in water.

(i) No person shall fail to possess a valid Class B Shellfish Processor permit before water storing shellfish.

(ii) No person shall fail to possess a valid shellfish water storage permit.

(iii) No person shall fail to operate a water storage facility that does not meet the requirements of sections 42.8, 42.9, and 42.10.

(iv) No person shall store shellfish in water in any tank which is not of a watertight construction.

(v) No person shall fail to store shellfish in any tank which does not have food grade interior surfaces.

(vi) No person shall fail to keep any water storage tank clean, orderly, sanitary and protected from flooding and storm water runoff.

(vii) No person shall fail to protect tanks from wild and domestic animals and other forms, conditions and agents of contamination.

(viii) No person shall permit the use of a tank for any purpose other than for the storage of shellfish.

(ix) No person shall permit the use of a tank for the storage of shellfish unless such tank is identified with a number or letter.

(x) No person shall fail to provide easy access to all portions of the tanks. Such accessibility shall not be achieved by walking through the tank storage water.

(xi) No person shall permit access to any tank used for the water storage of shellfish to anyone other than authorized persons or employees.

(xii) No person shall supply water to a water storage tank unless such water is from an approved source.

(a) An approved source of water is:

(1) water from a harvest area classified as certified pursuant to Part 41 of 6 NYCRR "Sanitary Condition of Shellfish Lands;" or

(2) water from a well that meets drinking water standards.

(b) Supply water must be examined at least two times annually at 6 month intervals by an approved laboratory and be of satisfactory quality. Examination results shall be submitted to the department's Shellfisheries Program.

(c) The degree of salinity of supply water shall be approximately equal to that of the waters from which such shellfish were harvested.

(xiii) No person shall fail to supply water continuously to a water storage tank in an amount sufficient to provide at least two complete changes of water in such tank in each 24-hour storage period.

(xiv) No person shall fail to use a container for the water storage of shellfish unless such a container is constructed from impervious, safe materials and are easily cleanable.

(xv) No person shall fail to use a container for the water storage of shellfish unless such a container is washed and sanitized within 2 hours after each use.

(xvi) No person shall fail to reuse a container for the water storage of shellfish unless such a container is washed and sanitized before use.

§42.13 Shellfish Harvesting, identification and handling by harvesters

The provisions of this section shall apply, as appropriate, to persons who, in wholesale commerce, engage in the shellfish harvesting activities described in the following subdivisions:

(a)Harvesting shellfish for use as food.

(1) Except as provided in this Subchapter, or in subdivisions (b) and (c) of this section, no person shall harvest shellfish from uncertified shellfish lands.

(2) No person shall harvest shellfish without a valid shellfish digger's permit issued by the department.

(3) No person shall fail to wash shellfish reasonably free from mud and sand with water as soon as possible after such shellfish have been harvested. Such water shall be tidal water from certified shellfish lands or fresh water of drinking water quality.

(4) No person shall fail to place harvested shellfish as soon as possible after harvesting in safe containers. Such containers shall have been stored in a manner which will prevent the contamination thereof.

(5) No person shall fail to affix securely to each container a readily visible tag at least two (2) and five-eights (5/8) inches wide and five (5) and one quarter(1/4) inches long constructed of a substantial, waterproof and tear resistant material with a reinforced point of attachment. Such tag must indicate, in waterproof ink, the following information in the specific order listed:

(i) harvester's name;

(ii) harvester's permit number;

(iii) harvest date;

(iv) harvest area (the description of the harvest area must not be less specific that the descriptions set out in subdivision {d} of this section);

(v) common name of the shellfish in the container;

(vi) the net weight or numerical count or standard measure of the shellfish in the container; and

(vii) the following statement in bold, capitalized type: "THIS TAG IS REQUIRED TO BE ATTACHED UNTIL THE CONTAINER IS EMPTY OR RETAGGED AND THEREAFTER KEPT ON FILE FOR 90 DAYS."

(6) No person shall fail to protect harvested shellfish from contamination, freezing and excessively high temperatures.

(7) No person shall fail to keep any boat, barge or vessel used for the harvesting or transporting of shellfish orderly.

(8) No person shall permit shellfish or shellfish containers to contact bilge water. This may be accomplished by the use of floorboards, false bottoms, or other effective methods.

(9) No person shall permit or otherwise allow any pet or other domestic animal to be on board a boat, barge or vessel used for the harvesting or transporting of shellfish and no person shall fail to immediately remove any such animal from such boat a, barge or vessel if such animal is found thereon.

(10) No person holding a digger's permit issued by the department shall harvest shellfish from a vessel that is not equipped with an approved marine sanitation device, portable toilet, or an impervious and cleanable container with tight fitting lid provided to contain human body wastes.

(11) No person shall throw, dump, discharge or permit or allow to run into the waters of certified shellfish lands any human body waste, garbage, cinders, ashes, oils, sludge, contaminant or refuse of any kind.

(12) No person shall fail to protect harvested shellfish from excessive temperatures.

(i) During the period May 1st through October 31st, no harvester shall fail, by 9:00 P.M. on the day of harvest, to either deliver harvested shellstock to a shellfish dealer or store the shellstock in a temperature controlled area, maintained between 33 degrees Fahrenheit (0.55 degrees Celsius) and 45 degrees Fahrenheit (7.2 degrees Celsius).

(ii) During the period November 1st through April 30th, no harvester shall fail, by 6:00 P.M. on the day following the date of harvest, to either deliver harvested shellstock to a shellfish dealer or the harvester shall store the shellstock in a temperature controlled area, maintained between 33 degrees Fahrenheit (0.55 degrees Celsius) and 45 degrees Fahrenheit (7.2 degrees Celsius).

(b) Harvesting shellfish for use as bait.

(1) No person shall harvest shellfish for use as bait from uncertified shellfish lands without a valid shellfish digger's permit and a valid bait harvester's permit issued by the department.

(2) No person harvesting shellfish for use as bait shall fail to place such shellfish in containers clearly and permanently labeled "BAIT" as soon as possible after such shellfish have been harvested.

(3) No person harvesting shellfish for use as bait shall fail to affix securely to each such container a readily visible tag at least two and five-eights inches wide and five and one-quarter inches long of substantial, waterproof and tear resistant material. Such tag shall indicate clearly in waterproof ink the harvester's name, the harvester's shellfish bait harvester's permit number, the common name of the shellfish contained in the container, an identification of the waters from which the shellfish were harvested, the date on which the shellfish were harvested and the words "FOR BAIT ONLY."

(4) No person shall permit shellfish harvested for use as bait to be transported or stored with or in any way allowed to come in contact with shellfish to be used as food for human consumption.

(5) No person shall permit containers, storage or transportation facilities or any other equipment used in connection with shellfish to be used as bait to be used in connection with shellfish for use as food unless such equipment has been cleaned.

(c) Harvesting shellfish for microbiological cleansing.

(1) It is unlawful for any person to undertake or participate in the harvest, transport or sale of shellfish for microbiological cleansing from uncertified lands without possessing a valid shellfish digger's permit, a valid shellfish microbiological cleansing-principal harvester's permit or a shellfish microbiological cleansing-harvesters permit or a combination of two or more of these permits, issued by the department. It is unlawful for any person to harvest shellfish for microbiological cleansing from uncertified shellfish lands unless such lands have been designated by the department as suitable for such purpose on such person's shellfish microbiological cleansing-harvester's permit. Shellfish lands will not be designated as suitable for the harvesting of shellfish for microbiological cleansing unless it has been determined that shellfish from such lands are not contaminated with fecal material, radionuclides or industrial wastes to such a degree that consumption of such shellfish might be hazardous. Shellfish lands will not be designated as suitable for the harvesting of shellfish for microbiological cleansing unless waters overlying such lands meet the criteria specified in section 47.3(c) of this Title.

(2) No person harvesting shellfish for microbiological cleansing shall fail to place such shellfish in containers clearly and permanently labeled "CLEANSING" as soon as possible after such shellfish have been harvested.

(3) No person harvesting shellfish for microbiological cleansing shall fail to affix securely to each container a readily visible red tag at least 2 5/8 inches wide and 5 1/4 inches long constructed of a substantial, waterproof and tear-resistant material with a reinforced point of attachment. Such tag shall indicate in waterproof ink the following information in the specific order listed: harvester's name, harvester's shellfish microbiological cleansing-harvester's permit number, harvest date, harvest area, common name of the shellfish in the container, the net weight or numerical count or standard measure of shellfish in the container, and the following statement in bold capitalized type: "THIS TAG IS REQUIRED TO BE ATTACHED UNTIL THE CONTAINER IS EMPTY AND THEREAFTER KEPT ON FILE FOR 90 DAYS" and the words "FOR CLEANSING ONLY."

(4) No person shall fail to transport shellfish for microbiological cleansing by such specific conveyance, along such specific route and to such specific cleansing plant as specified in such person's shellfish microbiological cleansing harvester's permit.

(5) No person shall permit, prior to the completion of microbiological cleansing, shellfish harvested for microbiological cleansing to be transported or stored with or in any way allowed to come into contact with microbiologically cleansed shellfish or shellfish harvested from certified shellfish lands.

(6) No person shall permit containers, storage or transportation facilities or any other equipment used in connection with shellfish to be microbiologically cleansed to be used in connection with shellfish taken from certified shellfish lands or in connection with microbiologically cleansed shellfish, unless such equipment has been cleaned.

(7) No person shall harvest shellfish for microbiological cleansing on a specific day unless the specific cleansing plant as specified in such person's microbiological cleansing-harvester's permit has sufficient cleansing tank capacity to begin the cleansing of such shellfish on such specific day.

(8) No person possessing a valid shellfish microbiological cleansing-harvester's permit issued by the department shall harvest shellfish from certified shellfish lands during the duration of the term of such permit.

(d) Harvest areas described. The harvest areas are described in this subdivision solely for the purposes of the department's shellfish sanitation program and are not intended to define the official boundaries of any body of water named herein. Reference points are taken from the appropriate NOAA nautical charts.

(1) Atlantic Ocean.

(i) Area A1. All shellfish lands of the Atlantic Ocean lying west of a line extending due south from Democrat Point on Fire Island.

(ii) Area A2. All shellfish lands of the Atlantic Ocean lying east of a line extending due south from Democrat Point on Fire Island and south of a line extending due east from Montauk Point.

(2) Block Island Sound-Area B. All shellfish lands of Block Island Sound and tributaries lying east of a line extending south-southeast from the eastern tip of Plum Island to the northern tip of Gardiners Island and following the eastern shoreline to Eastern Plain Point then extending east-southeast to Shagwong Point (Town of East Hampton) and following the shoreline to Montauk Point, north of a line extending due east from Montauk Point and south of a line extending from the eastern tip of Plum Island to Race Point (Fishers Island), following the southern shoreline of Fishers Island to East Point (Fishers Island) and extending east from East Point.

(3) Napeague Bay-Area N. All Shellfish lands of Napeague Bay and tributaries lying south of a line extending westerly from Shagwong Point (Town of East Hampton) to Eastern Plain Point on Gardiners Island, following the eastern shoreline of Gardiners Island to the southern tip then continuing westerly to Hog Creek Point (Town of East Hampton).

(4) Gardiners Bay-Area G. All shellfish lands of Gardiners Bay and tributaries lying west of a line extending south-southeast from the eastern tip of Plum Island to the northern tip of Gardiners Island and following the western shoreline to the southern tip, north of a line extending westerly from the southern tip of Gardiners Island to Hog Creek Point (Town of East Hampton) and following the shoreline to Cedar Point (Town of East Hampton), east of a line extending north-northwesterly from Cedar Point to Long Beach Point (Town of Southold) and south of a line following the shoreline from Long Beach Point to Orient Point then northeasterly from Orient Point to the western tip of Plum Island and following the shoreline to the eastern tip.

(5) Flanders Bay-Area P1. All shellfish lands of Flanders Bay and tributaries lying west of a line extending form Miamogue Point (Riverhead) to Red Cedar Point (Southampton).

(6) Great Peconic Bay-Area P2. All shellfish lands of Great Peconic Bay and tributaries lying east of a line extending from Miamogue Point (Riverhead) to Red Cedar Point (Southampton) and west of a line extending from New Suffolk (Southold) to the northern tip of Robins Island and continuing along the shoreline to the southern tip then extending from the southern tip of Robins Island to Cow Neck Point (Southampton).

(7) Little Peconic Bay-Area P3. All shellfish lands of Little Peconic Bay and tributaries lying east of a line extending from New Suffolk (Southold) to the northern tip of Robins Island and continuing along the shoreline to the southern tip then extending from the southern tip of Robins Island to Cow Neck Point (Southampton) and west of a line extending from Cedar Beach Point (Southold) to Jessup Neck (Southampton).

(8) Shelter Island Sound, Noyack Bay, Sag Harbor and Northwest Harbor-Area P4. All shellfish lands of Shelter Island Sound, Noyack Bay, Sag Harbor, Northwest Harbor and tributaries lying east of a line extending from Cedar Beach Point (Southold) to Jessup Neck (Southampton), south of a line from Paradise Point (Southold) to Crab Creek (Shelter Island) and west of a line extending from Cedar Point (East Hampton) to the easternmost point of land at Ram Island (Shelter Island) .

(9) Shelter Island Sound, Southold Bay and Orient Harbor-Area P5. All shellfish lands of Shelter Island Sound, Southold Bay Orient Harbor and tributaries lying north of a line extending from Paradise Point (Southold) to Crab Creek (Shelter Island) and west of a line extending from Long Beach Point (Southold) to the easternmost point of land at Ram Island (Shelter Island).

(10) Long Island Sound.

(i) Area LS1. All shellfish lands of Long Island Sound, except tributaries, lying west of a line extending due north from Old Field Point(Brookhaven).

(ii) Area LS2. All shellfish lands of Long Island except Fishers Island and except tributaries, lying east of a line extending due north of Old Field Point (Brookhaven) and north of a line extending from Orient Point (Southold) to the western tip of Plum Island, following the northern shoreline to the eastern tip, then from the eastern tip to Race Point (Fishers Island), following the southern shoreline of Fishers Island to East Point (Fishers Island) and due east from East Point.

(11) Fishers Island-Area F. All shellfish lands within one mile of the shoreline of Fishers Island.

(12) North Shore Waters.

(i) Area NS1. All shellfish lands of tributaries to Long Island Sound lying west of Matinecock Point (Oyster Bay).

(ii) Area NS2. Oyster Bay and Cold Spring Harbor. All shellfish lands of tributaries to Long Island Sound between Matinecock Point (Oyster Bay) and Lloyd Point (Huntington).

(iii) Area NS3. Huntington and Northport Bay. All shellfish lands of tributaries to Long Island Sound lying south of a line extending from Lloyd Point (Huntington) to Eatons Neck Point (Huntington).

(iv) Area NS4. All shellfish lands of tributaries to Long Island Sound and Smithtown Bay lying between Eatons Neck Point (Huntington) and Cranes Neck Point (Brookhaven).

(v) Area NS5. All shellfish lands of tributaries to Long Island Sound lying between Cranes Neck Point (Brookhaven) and the eastern side of the entrance to Mt. Sinai Harbor (Brookhaven).

(vi) Area NS6. All shellfish lands of tributaries to Long Island Sound lying between the eastern side of the entrance to Mt. Sinai Harbor (Brookhaven) and Roanoke Point (Riverhead).

(vii) Area NS7. All shellfish lands of tributaries to Long Island Sound lying between Roanoke Point (Riverhead) and Horton Point (Southold).

(viii) Area NS8. All shellfish lands of tributaries to Long Island Sound lying between Horton Point (Southold) to Orient Point (Southold).

(13) South Shore Waters Nassau County.

(i) Area SS1. All shellfish lands of East Bay, Hempstead Bay, and tributaries lying west of Wantagh State Parkway (Nassau County).

(ii) Area SS2. South Oyster Bay. All shellfish lands of South Oyster Bay and tributaries lying east of the Wantagh State Parkway (Nassau County) and west of the Nassau-Suffolk county line.

(14) South Shore Waters Suffolk County.

(i) Area SS3. Great South Bay. All shellfish lands of Great South Bay and tributaries lying east of the Nassau County -Suffolk County line and west of the Robert Moses Causeway (Suffolk County).

(ii) Area SS4. Great South Bay. All shellfish lands of Great South Bay and tributaries lying east of the Robert Moses Causeway (Suffolk County) and west of a line extending south from Nicoll Point (Islip) and following the Islip-Brookhaven town line.

(iii) Area SS5. Great South Bay. All shellfish of Great South Bay and tributaries lying east of a line extending south from Nicoll Point (Islip) and following the Islip-Brookhaven town line and west of a line extending due south from Homans Creek (Brookhaven) to the shoreline of Fire Island.

(iv) Area SS6. Patchogue Bay. All shellfish lands of Patchogue Bay and tributaries lying east of a line extending due south from Homan's Creek (Brookhaven) to the shoreline of Fire Island and west of a line extending southerly from Howell Point (Brookhaven) to Bellport Beach on Fire Island.

(v) Area SS7. Bellport Bay. All shellfish lands of Bellport Bay and tributaries lying east of a line extending southerly from Howell Point (Brookhaven) to Bellport Beach on Fire Island and west of a line extending due south from Smith Point (Brookhaven) to the shoreline of Fire Island.

(vi) Area SS8. Narrow Bay. All shellfish lands of Narrow Bay and tributaries east of a line extending due south from Smith Point (Brookhaven) to the shoreline of Fire Island and west of a line extending due south from Forge Point (Brookhaven) to the shoreline of Fire Island.

(vii) Area SS9. Moriches Bay. All shellfish lands of Moriches Bay and tributaries lying east of a line extending due south from Forge Point (Brookhaven) to the shoreline of Fire Island and west of a line extending from Tuthill Point (Brookhaven) to the western side of Moriches inlet.

(viii) Area SS10. Moriches Bay All shellfish lands of Moriches Bay and tributaries lying east of a line extending from Tuthill Point (Brookhaven) to the western side of Moriches Inlet and west of the bascule bridge separating Moriches bay and Moneybogue Bay.

(ix) Area SS11. Moneybogue Bay, Quantuck Bay, and Quogue Canal. All shellfish lands of Moneybogue Bay, Quantuck Bay and tributaries lying east of the bascule bridge separating Moriches Bay and Moneybogue Bay and west of the bascule bridge at Post Lane in Quogue (Southampton) which crosses the Quogue Canal.

(x) Area SS12. Shinnecock Bay. All shellfish lands of Shinnecock Bay and tributaries lying east of the bascule bridge at Post Lane in Quogue (Southampton) which crosses the Quogue Canal and west of the Ponquogue Bridge (Southampton).

(xi) Area SS13. Shinnecock Bay. All shellfish lands of Shinnecock Bay lying east of the Ponquogue Bridge including Heady and Taylor Creeks.

(xii) Area SS14. All shellfish lands of tributaries to the Atlantic Ocean between Shinnecock inlet and Montauk Point.

§42.14 Conveyances used for the transportation of shellfish

(a) No person shall utilize a conveyance for the transporting of shellfish unless such conveyance is equipped with an easily washable shellfish holding area.

(b) No person shall fail to keep holding areas orderly, in good repair and protected from and free from insects, pets, wild and domestic animals and other agents and forms of contamination.

(c) No person shall fail to keep holding areas on trucks, trailers and other conveyances enclosed to protect shellfish from contamination. Such holding areas shall be equipped with drains adequate to prevent the accumulation of water created by melting ice, condensation or other sources.

(d) No person shall fail to utilize conveyances with shellfish holding areas which are of sufficient size to permit the inspection of the contents thereof and to permit adequate air circulation.

(e) No person shall fail to transport shellstock in storage areas continuously maintained between 33 degrees Fahrenheit (0.55 degrees Celsius) and 45 degrees Fahrenheit (7.2 degrees Celsius), except when shellstock are being transported for periods less than four hours from the time the shellstock are brought to shore. No persons shall fail to use mechanical refrigeration for shellfish shipments of greater than four hours duration. Such mechanical refrigeration units shall be equipped with automatic temperature controls capable of maintaining the unit at temperatures not to exceed 45 degrees Fahrenheit (7.2 degrees Celsius). Storage areas on conveyances must have a functioning, readily visible, wall- mounted thermometer, accurate to plus or minus 2 degrees Fahrenheit.

(f) No person shall permit shellfish or a container containing shellfish to contact floor drainage or bilge water. Pallets, floorboards, false bottoms or other effective devices shall be used to accomplish this requirement.

(g) No person shall fail to keep shellfish holding areas on conveyances adequately lighted.

(h) No person shall fail to transport shellfish in containers which have been properly tagged or labeled in compliance with the provisions of this Part; except that a single shipment of containers of shellstock in transit entirely within the State of New York from a certified shellfish land to a shellfish processing facility may be accompanied by a single tag or label. Such tag or label shall contain all required information and such tag or label shall be readily available for inspection by the department.

(i) No person shall fail to transport unfrozen shucked shellfish, or portions thereof, at a maintained temperature of between 33 degrees Fahrenheit (0.55 degrees Celsius) and 45 degrees Fahrenheit (7.2 degrees Celsius).

( j) No person shall fail to transport frozen shellfish at a maintained temperature of 0 degrees Fahrenheit (-17.8 degrees Celsius) or lower.

(k) No person shall fail to transport shellfish in safe containers. Such containers shall have been stored in a manner which will prevent the contamination thereof.

§42.15 Microbiological cleansing of shellfish

(a) 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 Processor 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 thereof 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, buildings, 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) Operations for the microbiological cleansing of shellfish.

(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 purposes 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 purposes 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 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 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 department determines as a permit condition that such an approximation is necessary. Artificial sea water mixtures may be used to obtain the required salinity, as a permit condition, provided that such mixtures are approved by the department as a permit condition. The use of mixtures intended to 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 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 purposes 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 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 purposes with the lot number and 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 department, as a permit condition, prior to engaging in microbiological cleansing. Such containers 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 the department of any utility or equipment failure or other difficulty that may impede the proper microbiological cleansing of shellfish.

(xxxiv) No person engaged in the microbiological cleansing of shellfish shall permit non microbiologically 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 non microbiologically 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 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 than 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).

(f) 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 42.8 of this Part, and such tags or labels shall include the lot number of such microbiologically cleansed shellfish and the words "MICROBIOLOGICALLY CLEANSED."

(g) 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 42.7 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 names of the harvesters, the name 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 stand 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.

(h) 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 and on an additional tag conforming to the requirements of this Part if such original shippers' tag is of nonwaterproof construction.

(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.

§42.16 Microbiological cleansing supervision and associated fees and security requirements

(a) Supervision.

(1) All harvesting, transporting and processing of shellfish in connection with microbiological cleansing shall be subject to such supervision as the department deems necessary to protect the public health and safety and to conform to the provisions of this Part.

(2) All persons possessing a shellfish microbiological cleansing operator's permit or a shellfish microbiological cleansing-principal harvester's permit, pursuant to the provisions of this Part, must pay a supervision fee as specified below. Municipalities or other political subdivisions areexempt from the provisions of this section.

(b) Supervision fee and security requirements.

(1) The holder of a shellfish microbiological cleansing operator's permit shall pay supervision fees as set forth in this section.

(2) The holder of a shellfish microbiological cleansing-principal harvester's permit shall pay supervision fees as set forth in subdivisions (d) through (g) of section 45.5 of this title.

(3) A surety bond, or other negotiable security satisfactory to the department, with a value of non less than $10,000 for a shellfish microbiological cleansing operator's permit or $5,000 for a shellfish microbiological cleansing-principal harvester's permit shall be obtained and presented to the department by a permit applicant prior to the department's issuance of these respective permits. All or part of such bond or other security shall be payable to the State of New York Department of Environmental Conservation to ensure the payment of any outstanding amounts due the department by reason of a permittee's failure to comply with the supervision fee requirements of this Part.

(4) The provisions of this subdivision shall not apply to political subdivisions of the State of New York.

(c) Fee Schedule.

(1) Each permittee must pay a minimum annual supervision fee of an amount which equals the current annual entry-level salary for the job title of Food Inspector I, plus the cost of fringe benefits and an additional program overhead charge of 15 percent of the total salary and fringe benefits.

(2) Payments of the minimum fee must be made in quarterly segments.

(3) Payment for each quarter is due on the first working day of April, July, October and January of each year.

(4) As part of the permit application process, a written description of the scope and degree of supervision and the cost of such supervision to be required shall be signed by an appropriate department representative and the permit applicant. The initial fee shall be prorated based on the number of days remaining in the payment quarter during which the permit shall become effective or shall be for a biweekly period of two weeks, whichever is greater. An applicant's withdrawal of an approved application for s shellfish microbiological cleansing operator's permit before the permit's effective starting date shall result in the forfeiture of an amount of money equal to the current entry-level biweekly salary for the job title of Food Inspector I, plus the cost of fringe benefits and a program overhead charge of 15 percent of the total of salary and fringe benefits; the balance, if any, of the previously paid initial fee shall be returned to the applicant.

(d) Reimbursements due the permittee as a result of voluntary permit termination are determined based on the number of days remaining in the current payment quarter, provided the permittee has given the department a minimum of 30 days' advance written notice of the intent to terminate. Failure to so notify the department will result in the forfeiture of the payment for that payment quarter.

(e) The permittee must submit the entire quarterly payment to the department within 30 days following its due date. If the permittee fails to do this, the permit will be suspended. This suspension continues until the department has received all amounts due. However, if payment is not received within 60 days after becoming due, the permit will be revoked.

(f) If a permit is suspended or revoked, no supervision fees previously paid will be refunded and all fees for which payments is due will remain due.

(g) The fees provided for the above are the minimum fees which will be assessed by the department. In the event that the reasonable costs to the department of supervision over the removal of shellfish from uncertified areas exceed the minimum fee, additional fees sufficient to reimburse the department for additional costs will be assessed monthly. Payment of the additional fee will be due within 15 days of the receipt of notice of its assessment. The additional fees shall be assessed as follows:

(1) the cost of overtime resulting from on-site supervision; and/or

(2) the costs incurred by the department through the assignment of additional on-site supervisors. Such additional assessments will be based on the number of hours actually worked, with a provision that the minimum fee for each additionally assigned supervisor will be based on four hours per day;

(3) the cost of fringe benefits, holiday time, meals and travel expenses will be assessed and a program overhead charge based upon 15 percent of their total plus 15 percent of the total additional salaries will be assessed.

§42.17 Shellfish hazardous for use as food for human consumption

(a) When the department determines that shellfish might be hazardous for use as food for human consumption, such action shall be taken as necessary to protect the public health and welfare. The department may prohibit shellfish activities, such as, but not limited to, the harvesting, shucking, processing, packing, transporting, selling, storing and microbiological cleansing of shellfish for use as food. The department may advise the general public, shellfish industry and public health officials that shellfish might be hazardous for use as food.

§42.18 Examination and condemnation of shellfish

(a) Shellfish may be sampled and examined by the department as often as necessary to determine that such shellfish have been harvested, received, processed, shucked, packed, repacked, stored or conveyed in a manner in compliance with the provisions of this Part. The department may, upon written notice to the permit holder or person in charge place an embargo order on any shellfish that has been or where there is probable cause to believe that such shellfish have been harvested, processed, shucked, packed, repacked, stored or conveyed in a manner not in compliance with the provisions of this Part. Under an embargo order, shellfish shall be stored in a manner determined by the department. No person shall remove or alter an embargo order, notice or tag placed on shellfish by the department, and neither such shellfish nor the containers thereof shall be moved, relabeled, retagged, packed, repacked, processed, reprocessed, altered, sold, disposed of or destroyed without permission of the department, except by order of a court of competent jurisdiction. After the permit holder or person in charge has had notice of a hearing and an opportunity to be heard, as provided in section 42.6 of this Part, based on the evidence produced at such a hearing or on the basis of examination by the department, or in the event that the permit holder or person in charge defaults in appearing at such hearing, the department may vacate the embargo order, direct the permit holder or person in charge of the shellfish which were placed under the embargo order to denature or destroy such shellfish in a manner determined by the department or bring such shellfish into compliance with the provisions of this Part in a manner to be determined by the department.

(b) Samples of water, shellfish and other materials shall be collected and examined in a manner endorsed and /or approved by the United States Department of Health and Human Services, Public Health Service, Food and Drug Administration. Laboratories engaged in the bacteriological examination of water, shellfish and other materials 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 in order for results of such examinations to be acceptable to the department.

§42.19 Penalties

Any person violating any provision of this Part shall be subject to the penalties prescribed in the Environmental Conservation Law.