New Hampshire Code of Administrative Rules
He - Department of Health and Human Services
Subtitle He-P - Former Division of Public Health Services
Chapter He-P 2100 - BEVERAGES AND BOTTLED WATER
Part He-P 2151 - NEW HAMPSHIRE SHELLFISH SANITATION RULES: DEFINITIONS
Section He-P 2151.01 - Definitions

(a) "Adequately iced" means that the amount and application of the ice is sufficient to ensure that immediate cooling begins and continues for all shellfish. If ice slurry is used and the shellfish are submerged, the presence of ice in the slurry indicates adequate ice.

(b) "Approved" means a classification used as an identifier for a growing area where harvest for direct marketing is allowed.

(c) "Aquaculture" means cultivating shellfish in controlled conditions for human consumption.

(d) "Authority" means the state or local shellfish control authority or authorities or their designated agents, which are responsible for the enforcement of the National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish, as incorporated by reference in He-P 2152.01.

(e) "Certificate" means the document issued by the authority to a person to harvest or transport shellstock for commercial sale.

(f) "Certification" means the issuance of a numbered certificate to a person for a particular activity or group of activities that indicates:

(g) "Certification number" means the unique identification number issued by the authority to each dealer for each location, which consists of a one to 5 digit Arabic number preceded by the 2 letter state abbreviation and followed by a 2 letter abbreviation for the type of activity or activities the dealer is qualified to perform in accordance with these rules and the NSSP Guide for the Control of Molluscan Shellfish, as incorporated by reference n He-P 2152.01.

(h) "Commingling" means the act of combining different lots of shellfish.

(i) "Commissioner" means the commissioner of the New Hampshire department of health and human services, or the commissioner's designee.

(j) "Compliance schedule" means a written comply-by-date that is specified on the inspection report that provides a correction time period to eliminate key and other deficiencies.

(k) "Conditional area management plan" means a plan developed by the NH department of environmental services (DES) which establishes a strict set of criteria to be met for the growing area to remain in the open status.

(l) "Conditionally approved" means a classification used to identify a growing area that meets the criteria for the approved classification except under certain conditions described in a conditional area management plan.

(m) "Conditionally restricted" means a classification used to identify a growing area that meets the criteria for the restricted classification except under certain conditions described in a conditional area management plan.

(n) "Conveyance" means any type of container used to transport shellfish.

(o) "Critical control point (CCP)" means a point, step, or procedure in a food process at which control may be applied, and a food safety hazard may as a result be prevented, eliminated, or reduced to acceptable levels.

(p) "Critical deficiency" means a condition or practice which:

(q) "Critical limit" means the minimum or maximum value at 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.

(r) "Dealer" means a person to whom certification is issued for the activities of shellstock shipper, reshipper, shucker-packer, repacker, or depuration processor.

(s) "Department" means the New Hampshire department of health and human services.

(t) "Depuration" means the process of reducing the pathogenic organisms that may be present in shellstock by using a controlled aquatic environment as the treatment process.

(u) "Depuration processor (DP)" means a person who harvests or receives shellstock from growing areas in the approved classification or conditionally approved classification, restricted classification, or conditionally restricted classification in the open status and submits such shellstock to an approved depuration process.

(v) "Direct marketing" means the sale for human consumption of shellfish which:

(w) "Facility" means an establishment, equipment, and premises designed, built, or installed to perform a specific function.

(x) "Growing area" means any site which supports or could support the propagation of shellstock by natural or artificial means.

(y) "Harvest" means the act of removing shellstock from growing areas and its placement on or in a manmade conveyance or other means of transport.

(z) "Harvest area" means an area that contains commercial quantities of shellstock and may include aquaculture sites and facilities.

(aa) "Harvester" means a person who takes shellstock by any means from a growing area.

(ab) "Hazard analysis critical control point (HACCP)" means a systematic, science-based approach used in food production as a means to ensure food safety which is based upon the 7 principles identified by the National Advisory Committee on Microbiological Criteria for Foods.

(ac) "Hazard analysis critical control point (HACCP) plan" means a written document that delineates the formal procedures that a dealer follows to implement the HACCP requirements set forth in 21 CFR 123.6 as adopted by the Interstate Shellfish Sanitation Conference.

(ad) "In-shell product" means non-living, processed shellfish with one or both shells present.

(ae) "In-shell product packing" means the process of placing in-shell product into containers for introduction into commerce.

(af) "Interstate Certified Shellfish Shippers List (ICSSL)" means a United States Food and Drug Administration (FDA) publication of shellfish dealers, domestic and foreign, who have been certified by a state or foreign authority as meeting the public health control measures specified in the NSSP Guide for the Control of Molluscan Shellfish, as incorporated by reference in He-P 2152.01.

(ag) "Interstate Shellfish Sanitation Conference (ISSC)" means the organization which consists of agencies from shellfish producing and receiving states, the FDA, the shellfish industry, the National Oceanic and Atmospheric Administration (NOAA), the US Department of Commerce, and the US Environmental Protection Agency (EPA). The ISSC provides the formal structure wherein state regulatory authorities, with FDA concurrence, can establish updated guidelines and procedures for sanitary control of the shellfish industry.

(ah) "Key deficiency" means a condition or practice that might result in adulterated, decomposed, misbranded, or unwholesome product.

(ai) "Label" means any written, printed, or graphic matter affixed to or appearing upon any package containing shellfish.

(aj) "Lot of shellstock" means a single type of bulk shellstock or containers of shellstock of no more than one day's harvest from a single defined growing area gathered by one or more harvesters.

(ak) "National Shellfish Sanitation Program (NSSP)" means the cooperative program between the states, the FDA, and the shellfish industry for the sanitary control of shellfish that is adequate to ensure that the shellfish produced in accordance with the NSSP Guide for the Control of Molluscan Shellfish, as incorporated by reference in He-P 2152.01, will be safe and sanitary.

(al) "Other deficiency" means a condition or practice that is not defined as a critical or key deficiency and is not in accordance with the requirements of NSSP Guide for the Control of Molluscan Shellfish, as incorporated by reference in He-P 2152.01.

(am) "Performance based inspection" means when a dealer who has demonstrated a history of no critical deficiencies, no more than one key deficiency, and no more than 2 other deficiencies in any one inspection for a 3-year period, and therefore requires no more than one inspection per certification period.

(an) "Person" means any individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind, and any partnership, association, corporation, or other entity. Person includes the federal government, the state, and any other public or private entity.

(ao) "Post-harvest processing" means any process that has been validated using NSSP validation procedures which reduces the levels of pathogenic hazards to below the appropriate FDA action level or, in the absence of such a level, below the appropriate level as determined by the ISSC.

(ap) "Primary dealer" means those certified dealers who receive, purchase, or pack shellfish directly from harvesters.

(aq) "Processing" means any activity associated with the handling, shucking, freezing, packing, labeling, or storing of shellfish in preparation for distribution. This term includes the activities of a shellstock shipper, shucker-packer, repacker, reshipper, or depuration processor.

(ar) "Raw" means shellfish that have not been thermally processed to an internal temperature of 145º Fahrenheit or greater for 15 seconds, or the equivalent.

(as) "Relay" means to transfer shellstock from a growing area classified as restricted or conditionally restricted to a growing area classified as approved or conditionally approved for the purpose of reducing pathogens as measured by the coliform indicator group or poisonous or deleterious substances that may be present in the shellstock by using the ambient environment as the treatment process.

(at) "Repacker (RP)" means a person other than the original certified shucker-packer who repackages shucked shellfish into other containers.

(au) "Reshipper (RS)" means a person who purchases shellfish from dealers and sells the product without repacking or relabeling to other dealers, wholesalers, or retailers.

(av) "Restricted" means a classification used to identify a growing area where harvesting shall be by special certificate and the shellstock, following harvest, is subjected to a suitable and effective treatment process through relaying or depuration.

(aw) "Sanitation control record" means records that document the monitoring of sanitation practices and conditions during processing.

(ax) "Seed" means shellstock that is less than market size.

(ay) "Shellfish" means all fresh or frozen edible species of oysters, clams, or mussels, either shucked or in the shell, or scallops in any form, except when the final product form is the adductor muscle only.

(az) "Shellstock" means live molluscan shellfish in the shell.

(ba) "Shellstock shipper (SS)" means a dealer who grows, harvests, buys, or repacks and sells shellstock, who is not authorized to shuck shellfish nor to repack shucked shellfish, and who is permitted to buy, repack, and sell in-shell product as well as ship shucked shellfish.

(bb) "Shucker-packer (SP)" means a person who shucks and packs shellfish. A shucker-packer may act as a shellstock shipper or reshipper or may repack shellfish originating from other certified dealers.

(bc) "State shellfish standardization officer" means a person that has successfully completed the FDA standardization training course and the field evaluation phase of shellfish plant inspection with an FDA standardization officer.

(bd) "Temperature control" means the mechanical refrigeration or other conveyance pre-chilled and maintained at 45º F (7.22º C) or below and capable of reducing the internal temperature of shellstock to 50 ºF (10 ºC) or below within 4 hours.

(be) "Time of harvest" means the time when the first shellstock harvested is no longer submerged.

(bf) "Vehicle" means a machine or conveyance, including watercraft and aircraft, used to move or transport shellfish.

(bg) "Vibrio parahaemolyticus (V.p.)" means a bacterium that lives in brackish saltwater and causes gastrointestinal illness in humans.

(bh) "Wet storage" means the storage, by a dealer, of shellstock from growing areas in the approved classification or in the open status of the conditionally approved classification in containers or floats in natural bodies of water or in tanks containing natural or synthetic seawater at any permitted land-based activity or facility.