N.Y. Comp. Codes R. & Regs. tit. 6 § 42.2

Current through Register Vol. 46, No. 38, September 18, 2024

Section 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)Adequately Iced means that the amount and application of ice, originating from an approved source of potable water, is sufficient to ensure that immediate cooling begins and continues for all shellfish. It requires that the shellfish or containers of shellfish are completely surrounded by ice, within a self-draining container.

(b)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 95°F (35°C plus or minus 0.5°C).

(c)Allergen cross-contact means the transfer of an allergen from a food containing an allergen to a food that does not contain the allergen. An allergen is a substance that causes an allergic reaction.

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

(e)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.

(f)Breading means any dry edible preparation containing one or more dry ingredients used in the processing of shellfish for use as food for human consumption.

(g)Business address or place of business means a physical location identified in a permit application as the business address where any shellfish-related activities are conducted.

(h)Certified shellfish lands means shellfish lands from which the harvesting of shellfish for use as food is permitted by commissioners order.

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

(j)Coliform group means all of the aerobic and facultative anaerobic, gram-negative, nonspore forming, rod-shaped bacilli which ferment lactose broth with gas formation within 48 hours at 95°F (35°C plus or minus 0.5°C).

(k)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 capable of growing and/or reproducing in or on standard methods agar when such agar is incubated aerobically for 45 to 51 hours at 95°F (35°C plus or minus 0.5°C).

(l)Commissioner means the Commissioner of Environmental Conservation or the commissioners duly authorized representative.

(m)Communicable disease means any disease listed in section 2.1 of Title 10 NYCRR, and any other diagnosed foodborne illness that may be transmitted through the handling of food.

(n)Compliance schedule means a written schedule that provides a deadline by which Key or Other deficiencies must be corrected.

(o)Confidential fisheries data means shellfish landings data, statistics or other information collected by the department from the holders of Class A, B, D or E shellfish dealers permits.

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

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

(r)Corrective action means an action required to be taken in order to address deviations from a critical limit identified in the shellfish Hazard Analysis Critical Control Point (HACCP) Plan.

(s)Corrective action plan means a written plan which outlines any corrective actions required to be taken in order to address any deficiencies, including deviations from a critical limit identified in the shellfish HACCP Plan.

(t)Critical control point means a point, step or procedure in the handling, storing, packing, processing, shipping or shucking of shellfish at which one or more controls can be applied to prevent, eliminate, or reduce a food safety hazard.

(u)Critical deficiency means a condition or practice which results in the production of a product that is unwholesome or presents a threat to the health or safety of the consumer.

(v)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.

(w)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.

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

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

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

(aa)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.

(ab)Fecal coliform means that portion of the coliform group which will produce gas from lactose in an EC or A-1 multiple tube procedure liquid medium within 24 hours, plus or minus 2 hours, in a water bath maintained at 112.1°F (44.5°C, plus or minus 0.2°C), or another approved method acceptable to the department.

(ac)Food means ice, shellfish or any ingredient used on or in shellfish products.

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

(ae)Harvester education course means a training course approved by the department that includes safe shellfish harvesting, handling, and transportation practices.

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

(ag)Internal temperature means the external temperature of the shell of the shellfish at the center of a packaged mass of shellstock in its container.

(ah)Key deficiency means a condition or practice which may result in product that is unwholesome, misbranded, or presents a threat to the health or safety of the consumer.

(ai)Land or landed means the bringing of shellfish to shore or the transfer of shellfish from a vessel to shore, pier, wharf, dock or similar structure.

(aj)Lot of shellstock or lot of shellfish means a single type of bulk shellstock or containers of shellstock of not more than one days harvest from a single defined harvest area gathered by one or more harvesters. A lot may also be used to segregate shellfish by harvest times or intended use for the purpose of complying with the time to temperature requirements.

(ak)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 Governor Mario M. Cuomo Bridge (formerly known as the Tappan Zee Bridge).

(al)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 or approved by the United States Department of Health and Human Services, Public Health Service, Food and Drug Administration.

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

(an)Non-hazardous means not actually or potentially dangerous to human health.

(ao)Other deficiency means a condition or practice that is not defined as critical or key but is not in accordance with the requirements of this Part.

(ap)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.

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

(ar)Person means any individual, group of individuals, public or private corporation, limited liability company, industry, co-partnership, joint-stock company, not for profit organization, association, firm, legal entity, trust or estate.

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

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

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

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

(aw)Safe means nonhazardous.

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

(ay)Sewage means water-borne refuse, including fecal material of humans and other warmblooded animals.

(az)Shaded means protected from exposure to sunlight that may cause a significant increase in post-harvest growth of Vibrio bacteria due to an increase in temperature.

(ba)Shellfish means, for the purpose of this Part, fresh or frozen oysters, clams, mussels or scallops or any edible portion thereof except for scallops when the final product is only the adductor muscle.

(bb)Shellfish dealer means any person who engages in the processing, packing, repacking, receipt, storage, possession, transportation, distribution, or shipment of shellfish in wholesale commerce, excluding freight forwarders.

(bc)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.

(bd)Shellfish sanitary inspection means an unannounced/announced inspection of facilities, buildings, structures, invoices, shellfish tags and labels, hazard analysis, HACCP Plans and any other records required to be kept pursuant to this Part.

(be)Shellstock means live molluscan shellfish in the shell.

(bf)Shipper means a shellfish dealer who receives and distributes or redistributes shellfish in wholesale commerce.

(bg)Shuck means to release shellfish from one or both shells. Shucker means a person who performs such activities.

(bh)Standard measure means a bushel with a volume of 2,150.42 cubic inches or otherwise in agreement with criteria set out in the NYS Agriculture and Markets Law.

(bi)Start of harvest or time of harvest means the time when the first shellstock is taken from the water, or in the case of intertidal harvest, the time of first exposure.

(bj)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.

(bk)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°C, plus or minus 0.5°C.

(bl)Transaction record means a written or computer-generated record of all shellfish received or shipped in wholesale or retail commerce.

(bm)Tributary means a harbor, river, creek, pond, stream, or other body of water that is fed from or fed into a larger body of water such as a sound, ocean or bay.

(bn)Trip record means a written document that includes the harvester name, harvester permit number, harvest area, the harvest date and time and, if applicable, the temperature of each lot of shellstock harvested.

(bo)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 commissioners order.

(bp)Unsafe means the inverse of safe.

(bq)Unwholesome means the inverse of wholesome.

(br)Vibrio parahaemolyticus Control Plan (VpCP) means a written plan developed by the department in response to a shellfish related Vp illness outbreak or unacceptable risk of illness. Such plan outlines control measures that must be taken by shellfish harvesters and shellfish dealers to prevent or decrease the likelihood of Vp related illnesses occurring due to the consumption of raw or undercooked shellfish.

(bs)Water of drinking quality means water that meets the requirements of Part 5 of Title 10 NYCRR.

(bt)Water storage or wet storage means the holding of shellstock harvested from certified shellfish lands in tanks of water, or containers of shellstock harvested from certified shellfish lands held in certified bodies of water for purposes of storage or de-sanding.

(bu)Wholesale commerce means the selling or offering for sale of shellfish to a person other than the ultimate consumer, including restaurants or food service establishments, 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.

(bv)Wholesome means shellfish that is fresh, unspoiled, clean and free from adulteration, contamination, evidence of previous temperature abuse, and suitable for human consumption without altering its physical or organoleptic characteristics.

(bw)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.

N.Y. Comp. Codes R. & Regs. Tit. 6 § 42.2

Amended New York State Register June 5, 2019/Volume XLI, Issue 22, eff. 6/5/2019

Amended New York State Register November 1, 2023/Volume XLIV, Issue 44, eff. 11/1/2023