7.6.2.15 SHELLFISH PROCESSING AND CERTIFICATION REQUIREMENTS:
A. Specific Shellfish Processing Definitions, as used in 7.6.2.15:
(1) "certification" means a State program whereby the State of New Mexico assures receiving jurisdictions that a shellfish processor meets criteria of the National Shellfish Sanitation Program (NSSP) and is eligible for interstate shipment and listing in the Interstate Certified Shellfish Shippers list;
(2) "certification number" means the number assigned by the Health Authority to each certified shellfish dealer, consisting of a three digit number preceded by two letter state abbreviation (NM) and followed by the two letter symbol designating the type of operation certified (RP, RS, SS or SP);
(3) "commingling" means the act of combining different species of shellfish or lots of shellfish or shucked shellfish;
(4) "controlled purification" means the process of using a controlled aquatic environment to reduce the level of bacteria and viruses in live shellfish;
(5) "dealer" means a commercial shellfish shipper, reshipper, shucker-packer, repacker, or depuration processor or operation;
(6) "depuration" means a process to reduce the number of pathogenic organisms that may be present in shellfish harvested from moderately polluted (restricted) waters to such levels that the shellfish will be rendered safe for human consumption without further processing;
(7) "dry storage" means the storage of shellstock out of water;
(8) "Interstate Certified Shellfish Shippers List" means the listing, published by FDA, of dealers certified by the states to pack and ship shellfish;
(9) "ICSSL" means the Interstate Certified Shellfish Shippers List;
(10) "label" means any written, printed, or graphic matter affixed to or appearing upon any package containing shellfish;
(11) "lot of shellstock" means a collection of bulk shellstock or containers of shellstock of no more than one day's harvest from a single defined growing area harvested by one or more harvesters;
(12) "lot of shucked shellfish" means a collection of containers of no more than one day's shucked shellfish product produced under conditions as nearly uniform as possible, and designated by a common container code or marking;
(13) "National Shellfish Sanitation Program" means the Cooperative State - FDA - Industry Program for the sanitary control of harvesting, shipping and processing of shellfish and the certification of interstate shellfish shippers;
(14) "NSSP" means the National Shellfish Sanitation Program;
(15) "processor" means a person who depurates, shucks, packs, or repacks shellfish;
(16) "Repacker" or "RP" means a person other than the original certified shucker-packer who repacks shucked shellfish into other containers. A repacker may also repack and ship shellstock. A repacker shall not shuck shellfish;
(17) "Reshipper" or "RS" means a person who purchases already packaged and tagged shucked shellfish or shellstock from other certified shippers and sells the product without repacking or relabeling to other certified shippers, wholesalers, or retailers;
(18) "shellfish" means all edible species of oysters, clams, and mussels either shucked, in the shell, fresh or fresh frozen, whole or in part; but does not include scallop species from the family Pectinidae;
(19) "shellstock" means fresh, live shellfish in the shell;
(20) "Shellstock Shipper" or "SS" means a person who grows, harvests, buys, or repacks and sells shellstock. Shellstock shippers are not authorized to shuck shellfish nor to repack shucked shellfish. A shellstock shipper may ship shucked shellfish maintained in their original package;
(21) "shucked shellfish" means shellfish, whole or in part, from which one or both shells have been removed;
(22) "Shucker-Packer" or "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;
(23) "transaction record" means a form or forms used to document each purchase or sale of shellfish at the wholesale level; and
(24) "wet storage" means the temporary storage of shellfish from approved sources, intended for marketing, in containers or floats in natural bodies of water or in tanks containing natural or synthetic seawater.
B. General Shellfish Processing Requirements:
(1) Raw shellfish shall be obtained from approved waters and produced, handled, and distributed in a sanitary manner.
(2) Shellfish shall comply with the general requirements of the Federal Food, Drug, and Cosmetic Act, and also with requirements of the National Shellfish Sanitation Program administered by FDA and the Interstate Shellfish Sanitation Conference.
(3) All applicable portions of this Part shall apply to shellfish shipping, reshipping, repacking and wet storage.
(4) No shellfish shall be offered for sale for food in New Mexico unless it is obtained from shellfish dealers currently certified by the appropriate state authority. Shellfish obtained from sources other than those listed in the most current monthly publication of the Interstate Certified Shellfish Shippers List, shall be considered unfit for human consumption.
(5) No person shall engage in any activity requiring certification under this Part without having applied for, and obtained, a certification number issued by the Health Authority for the particular activity.
C. Permits And Certification:
(1) The permit requirements of 7.6.2.8.E apply to shellfish shippers, reshippers, repackers and wet storage.
(2) In addition to the requirements of 7.6.2.8.A, repackers of shucked shellfish and operators of wet storage facilities shall submit for review and approval, complete operational procedures for all phases of the activity, as required in 7.6.2.12.G.
(3) A certificate and certification number shall be issued to persons who obtained shellstock and shucked shellfish from certified dealers and sell their shellfish to instate wholesale or retail outlets, other certified shippers or in interstate commerce.
(4) Shellstock shippers, repackers, and reshippers who fully comply with all certification requirements and also sell their shellfish in interstate commerce will be included in the Interstate Certified Shellfish Shippers List. Lack of compliance with the certification requirements may result in decertification or permit suspension.
(5) Transportation agents or common carriers utilized by certified dealers do not have to be certified.
D. Shellfish Certificate:
(1) The Health Authority’s certifying officer responsible for completing forms FDA 3038b, SHELLFISH CERTIFICATE, shall forward the complete form to FDA. (HFF-340), 200 "C" Street, SW, Washington, D.C. 20204 for publication in the monthly listing and a copy to the FDA. Regional or District office. The interstate shellfish certificate shall provide the following information:
(a) the usual business name that will appear on the Interstate Certified Shellfish Shippers List;
(b) a unique certificate number for each establishment consisting of a one to five digit Arabic number, preceded by the letters (NM) and followed by the two letter abbreviations for the type of operation the dealer is qualified to perform; repacker (RP), shellstock shipper (SS), or reshipper (RS);
(c) a business address where inspections are conducted; and
(d) an expiration date.
(2) Each shipper’s certification shall be renewed annually. Certification renewal shall be completed at least fifteen (15) days prior to the expiration date each year. The renewal certificate should be sent to the FDA's Shellfish Sanitation Branch at least fifteen (15) days prior to the date of printing of the ICSSL during the month the current certificate expires.
E. Shellstock Shippers:
(1) Persons who buy and sell shellstock from a harvester or other certified dealer and who repackage and relabel shellstock shall be certified by the Health Authority as a shellstock shipper. A shellstock shipper shall not shuck, relabel or repackage shucked shellfish, but may reship already packaged shellstock or shucked shellfish.
(2) All shellstock shall originate from an approved source and be packaged, protected and identified as specified in 7.6.2.15.E. All shellstock received from other certified shellfish dealers shall have a durable, waterproof tag (at least 2-5/8 inches by 5-1/4 inches) on each container with the following information:
(a) the dealer’s name and address:
(b) the dealer’s certification number;
(c) the original shellstock shipper’s certification number;
(d) the date of harvest; and
(e) the most precise identification of the harvest location as is practicable.
(3) Fresh, living shellstock shall be shipped and stored at ambient air temperatures of 50 degrees F or below and under such conditions as to prevent contamination. Shellstock shall be identified and records maintained in such a manner that containers can be traced back to their source.
(4) All repacking and relabeling of shellstock shall be done as follows:
(a) only clean and wholesome shellfish shall be repacked. Repacking facilities and equipment shall meet all applicable sanitation requirements of these regulations to assure that microbiological deterioration does not occur;
(b) shellstock from different lots shall not be commingled; and
(c) each container of repacked or relabeled shellstock shall be identified as to harvest area, date of harvest, type and quantity of shellfish, and the certifications number of the shellstock shippers.
(5) Records shall be maintained for one year which will permit a package of shellstock to be traced back to the harvest area. Records shall also include the date of harvest and if possible, the harvester.
F. Shellfish Reshippers:
(1) Persons who obtain shellstock or shucked shellfish from certified dealers and sell the shellstock to other certified shippers, non-certified retailers, or in interstate commerce shall be certified by the Health Authority as shellstock reshippers. Shellstock reshippers may not buy or sell shellstock from a harvester but must obtain shellstock from a certified dealer.
(2) A shellstock reshipper shall not repack shellstock or shuck or repack shucked shellfish, nor shall a reshipper remove or alter any existing label information on any packaged shellstock. By contrast, a shellstock shipper may repackage shellstock but not shucked shellfish.
(3) The original labels on shucked shellfish and certified dealer's tags or labels on shellstock shall be maintained on the product containers. Labeling or tagging information shall not be altered or removed, nor shall shellstock be commingled, resorted, or repackaged. The name and certification number of the reshipper shall be added to the package.
G. Shellfish Repackers:
(1) Persons who remove shucked shellfish from one package and place and relabel them in another package shall be certified by the Health Authority as a shellfish repacker.
(2) Shucked shellfish to be repacked shall originate only from a certified shucker-packer and upon receipt, shall be refrigerated, protected and labeled in compliance with 7.6.2.15.H.
(3) Records of each purchase shall be maintained by the dealer who will permit all shucked shellfish to be traced back to the source.
(4) Shellfish from different lots shall not be commingled during repacking.
(5) The internal temperature of the fresh shellfish shall be 45 degrees F or less at the time of receipt, while frozen shellfish shall be at 0 degrees F or less.
(6) Only wholesome shellfish shall be repacked, and good sanitary practices shall be followed to minimize microbial growth and product deterioration.
(7) The facilities in which shucked shellfish are repacked shall comply with the general sanitation requirements of this Part.
H. Shellfish Quality Control:
(1) When shucked shellfish are handled, the following requirements shall apply:
(a) The certified dealer receiving shellfish shall assure that incoming shellfish are:
(i) obtained from a certified dealer;
(ii) properly tagged or otherwise identified to show their source;
(iii) accompanied by all required transaction records; and (iv) clean and wholesome.
(b) Shucked shellfish shall be held and transported at 41 degrees F or less. Storage and shipping of sealed containers of shucked shellfish in wet ice is highly recommended.
(c) Packaged shellfish to be frozen shall be arranged to insure rapid freezing, and shall be freezing. Frozen shellfish shall be handled in such a manner as to remain frozen solid, and held at 0 degrees F or less.
(d) All containers holding shucked shellfish shall be kept covered during refrigeration.
(e) Ice shall be manufactured at the establishment from potable water in a commercial machine which has been properly installed without cross connections, or in another establishment approved by the Health Authority.
(f) Complete and accurate legible transaction records shall be maintained by each certified dealer that provide all information necessary to trace all purchases and sales of shellfish back to their source.
(g) The general equipment and construction requirements outlined in 7.6.2.10.A through G shall apply to all buildings, structures, and equipment.
(2) When shellstock is handled, the following requirements shall apply:
(a) Shellstock shall be obtained from a certified dealer which are properly tagged or identified to show their source, and which are accompanied by all required transaction records. Reshippers shall not obtain shellstock directly from harvesters.
(b) Complete, accurate and legible transaction records shall be maintained by each certified dealer which provide all information necessary to trace all purchases and sales of shellstock back to their source.(c) Shellstock in dry storage shall be protected from contamination and maintained in ambient air temperatures of 41 degrees F or below. Shellstock from different sources shall be separated as necessary to avoid commingling and aid in maintaining source identity.
(d) Wet storage shall be in accordance with 7.6.2.15.I.
(e) All trucks used for hauling bulk, bagged or otherwise packaged shellstock shall be constructed, operated, and maintained so as to prevent contamination, deterioration, or decomposition of the shellfish, and shall be kept clean.
(f) Adequately refrigerated trucks shall be used to transport shellstock when the ambient air temperature is such that unacceptable bacterial growth or deterioration may occur.
(g) The general equipment and construction requirements outlined in 7.6.2.10.A through G shall apply to all buildings, structures and equipment.
(3) If a shellfish reshipper business consists only of a truck, a permanent business address where vehicles and records are available for inspection shall be maintained. The following requirements shall apply:
(a) Such vehicles shall comply with the requirements of 7.6.2.15.H(2)(e).
(b) The source of shellfish shall comply with the requirements of 7.6.2.15.H(1)(a) and 7.6.2.15.H(2)(a).(c) Refrigeration and shipping of shucked shellfish shall comply with provisions of 7.6.2.15.H(1)(b) and (c).
(d) Records shall be maintained as specified in 7.6.2.15.H(2)(b).
I. Wet Storage Of Shellfish:
(1) Shellfish for wet storage shall originate only from a certified dealer and shall be identified and shipped in accordance with this Part. Wet storage may be used for temporary storage of approved shellfish, for desanding and for improving palatability.(2) Each wet storage site or facility shall be inspected and approved annually by the Health Authority. Factors to be reviewed include, but are not limited to:
(a) a plan giving the design of the storage facility;
(b) the source of water to be used for wet storage and details of any water treatment system;
(c) the purpose of the wet storage operation such as holding, conditioning, or salinization, and any species specific physiologic factors that may affect design criteria;
(d) the design, construction and operation of the facility and equipment; and
(e) the effectiveness of cleaning and sanitization.
(3) Wet storage operations shall be conducted in structures that comply with the general equipment and construction requirements outlined in 7.6.2.10.A through G.
[7.6.2.15 NMAC – Rp 7 NMAC 6.1.801 to 809, 08/12/2000]