S.C. Code Regs. § § 61-47.A

Current through Register Vol. 48, No. 10, October 25, 2024

Section 61-47.A - GENERAL PROVISIONS

1. Purpose and Scope. This regulation outlines requirements for producers, harvesters, processors, and transporters of shellfish and is intended to protect the health of consumers of shellfish. The requirements, standards, and implementation methods outlined herein are consistent with the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, published by the United States Department of Health and Human Services, U.S. Food and Drug Administration. The National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish is partially incorporated by reference within these regulations. This Regulation is intended to protect the health of consumers of shellfish by:

(a) Establishing sanitary controls for the production, processing, harvesting, handling, distribution, and transportation of shellfish;

(b) Classifying coastal shellstock growing areas in accordance with accepted public health standards;

(c) Prohibiting the distribution of adulterated shellfish; and

(d) Establishing permit and certification requirements for commercial shellfish activities.

2. Definitions. For the purpose of this regulation:

(a) Adulterated means any one of the following:

(1) Shellfish that have been harvested from closed areas;

(2) Shellfish that have not been grown, harvested, stored, treated, transported, handled, shucked, packed, tagged, labeled, or offered for sale in compliance with this Regulation;

(3) Shellfish deemed unsafe as outlined in E.2;

(4) Shellfish that are putrid or unfit for human consumption;

(5) Shellfish that have been exposed to any unsanitary conditions;

(6) Shellfish that contain any added substance, unless the substance is authorized by the Department or the United States Food and Drug Administration;

(7) determined to contain any poisonous or deleterious substance at a level or concentration likely injurious to public health.

(b) Adverse Pollution Condition means a state or situation caused by meteorological, hydrological or seasonal events or point source discharges that has historically resulted in elevated fecal coliform levels in a particular harvest area.

(c) Approved means a shellfish water quality classification that allows shellfish harvest for direct marketing for human consumption.

(d) Approved Area means a growing area where the water quality has been classified by the Department for harvesting shellfish for direct marketing for human consumption.

(e) Aquaculture means the cultivation of shellfish in land-based artificial growing or harvest areas, or confined cultivation in South Carolina Department of Natural Resources-permitted natural growing or harvest areas.

(f) Bulk means any of the following:

(1) A single lot of shellstock stored or shipped in individual packages which are contained within a sealed master carton or on a wrapped pallet;

(2) A single lot of unpackaged shellstock shipped in a single large-volume container such as a vehicle or vessel;

(3) A single lot of shellstock held in multiple large capacity tubs, totes, net brailers, or other holding units when being transported from a growing area to a certified shipper.

(g) Certified Shipper means a person engaged in the business of selling, distributing or otherwise transporting shellfish and who has a valid certification as a Depuration Processor(DP), Shucker-Packer(SP), Repacker(RP), Shellstock Shipper(SS), or Reshipper(RS) issued by the state in which his facility is located.

(h) Certification Number means the unique identification number assigned by the Department to each certified shipper.

(i) Classification or Classify means the designation of a growing area harvest category or categories. A growing area may be classified as any combination of approved, conditionally approved, restricted, conditionally restricted, or prohibited.

(j) Classified Growing Area means a growing area for which the Department has completed a sanitary survey report and assigned classifications of approved, conditionally approved, restricted, conditionally restricted, or prohibited.

(k) Closed Area means a growing area where the harvesting of shellfish is temporarily or permanently not allowed. The Department may place any growing area in a closed area status.

(l) Coliform Group means all of the aerobic and facultative anaerobic, gram negative, nonspore forming, rod shaped bacilli that ferment lactose broth with gas formation within forty-eight (48) hours at ninety-five (95) degrees Fahrenheit (35 degrees (0.5 degrees Centigrade).

(m) Commingle or Commingling means the act of combining different lots of shellstock or shucked shellfish.

(n) Conditionally Approved means a shellfish water quality classification used to identify a growing area that meets approved criteria except under conditions described in a management plan.

(o) Conditionally Approved Area means a growing area that meets approved area criteria under certain environmental conditions determined by the Department. Direct harvesting of shellfish for human consumption is allowed at times and under conditions determined by the Department through collection of water quality and pollution source data. Conditionally approved area management employs criteria specified in a management plan.

(p) Conditionally Restricted means a shellfish water quality classification used to identify a growing area that meets restricted criteria except under conditions described in a management plan.

(q) Conditionally Restricted Area means a growing area that meets Restricted Area criteria under specific conditions determined by the Department. Conditionally restricted area management employs criteria specified in a management plan.

(r) Container means any bag, box, crate, tub, carton, or other conveyance in which shellfish may be held, carried or transported.

(s) Critical Control Point (CCP) means a point, step or procedure in a food process at which control can be applied, and a food safety hazard can, as a result of the control, be prevented, eliminated or reduced to acceptable levels.

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

(u) 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.

(v) Department means the South Carolina Department of Health and Environmental Control or agents thereof having responsibility for enforcing these regulations.

(w) Depletion means the removal and disposal of all market-size shellfish from a growing area in a manner to prevent human consumption.

(x) Depuration means the process of using a controlled aquatic environment to reduce the level of bacteria and viruses in live shellfish.

(y) Depuration Facility means the physical structure wherein depuration is accomplished, including all the appurtenances necessary to the effective operation thereof.

(z) Depuration Processor (DP) means a person who is certified to receive shellstock from approved or restricted growing areas and submit such shellstock to a depuration process.

(aa) Dry Storage means the storage of shellstock out of the water.

(bb) Employee means an individual who handles, stores, transports, sells, or distributes shellfish and is employed by someone with a shellfish certificate or permit.

(cc) Fecal Coliform means that portion of the coliform group that will produce gas from lactose in an EC or A-1 multiple tube procedure liquid medium within twenty-four (24) (+" 2) hours in a water bath maintained at one hundred twelve (112) degrees Fahrenheit [forty-four and one-half (44.5) (0.2 degrees Centigrade].

(dd) Growing Area means an estuary or coastal river area delineated by the Department that supports or could support live shellfish. For purposes of this regulation, growing waters shall be synonymous with growing area.

(ee) HACCP is an acronym that stands for Hazard Analysis Critical Control Point, a systematic, science based approach used in food production as a means to assure food safety.

(ff) HACCP Plan means a written document that delineates the formal procedures that a processor follows to implement the HACCP requirements set forth in 21 CFR Section 123.6 (April 1, 2007) as adopted by the Interstate Shellfish Sanitation Conference.

(gg) Harvest means the act of removing shellstock from growing areas and it's placement on or in manmade conveyance or other means of transport.

(hh) Harvester means a person who gathers shellfish by any means from a growing area.

(ii) Lot means any of the following:

(1) A single type of bulk shellstock or containers of shellstock of no more than one day's harvest from a single defined growing area;

(2) 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;

(3) Shellstock harvested for depuration from a particular area during a single day's harvest and delivered to one depuration facility.

(jj) Mariculture means controlled cultivation in confinement of marine and estuarine organisms in salt waters.

(kk) Marina means any of the following:

(1) locked harbor facility;

(2) any facility which provides fueling, pump-out, maintenance or repair services (regardless of length);

(3) any facility which has effective docking space of greater than 250 linear feet or provides moorage for more than 10 boats;

(4) any water area with a structure which is used for docking or otherwise mooring vessels and constructed to provide temporary or permanent docking space for more than ten boats, such as a mooring field; or

(5) a dry stack facility.

(ll) National Shellfish Sanitation Program means the program cooperatively developed by state, United States Food and Drug Administration, and shellfish industry representatives resulting in sanitary control guidelines that ensure that the shellfish produced in accordance with guidelines will be safe and sanitary.

(mm) National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish means the 2013 version of the United States Food and Drug Administration document with that title that consists of a Model Ordinance, supporting guidance documents, recommended forms, and other related materials associated with the National Shellfish Sanitation Program. Portions of the document are incorporated by reference herein and such referenced sections shall have effect as if fully recited within the text of this regulation. Copies can be obtained through the U.S. Food and Drug Administration or the S.C. Department of Health and Environmental Control, 2600 Bull Street, Columbia, SC 29201.

(nn) Person means any individual, partnership, company, corporation, trustee, association, agency, or any public or private entity.

(oo) Poisonous or Deleterious Substance means a toxic compound occurring naturally or added to the environment that may be found in shellfish or shellfish growing waters for which a regulatory tolerance limit or action level has been established or may be considered harmful to public health. Examples of naturally occurring substances would include paralytic shellfish toxins and trace elements geologically leached from the environment, such as mercury; examples of added substances would include agricultural pesticides and polynuclear aromatics.

(pp) Post Harvest Processing means processing of shellfish for the purpose of added safety or quality that involve hazards not addressed by controls in the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish Model Ordinance for shucker-packers, repackers, shellstock shippers, or reshippers.

(qq) Process means those actions related to the operation of the Certified Shipper facilities of Depuration Processors(DP), Shucker-Packers(SP), Repackers(RP), Shellstock Shippers(SS), and Reshippers(RS).

(rr) Processor means a certified shipper.

(ss) Prohibited means an administrative classification that disallows shellfish harvest for human consumption.

(tt) Prohibited Area means a growing area that has been closed by the Department for the harvesting of shellfish for any purpose related to direct human consumption.

(uu) Raw means shellfish that have not been thermally processed:

(1) to an internal temperature of one hundred and forty-five (145) degrees Fahrenheit or greater for fifteen (15) seconds (or equivalent); or

(2) to alter the organoleptic characteristics.

(vv) Relaying means the transfer of shellstock from restricted areas or conditionally restricted areas to approved or conditionally approved areas for natural biological cleansing using the ambient environment as a treatment system.

(ww) Repacker (RP) means a certified shipper who packs shucked shellfish into containers other than those in which they were originally packaged. A repacker may act as a shellstock shipper.

(xx) Repacking means the transfer of shucked shellfish into containers other than those in which they were originally packaged.

(yy) Reshipper (RS) means certified shippers who purchase shellfish from other certified shippers and sell or distribute the shellfish without repackaging.

(zz) Restricted means a shellfish water quality classification that does not meet approved water quality criteria, disallows direct marketing of shellfish, and allows shellfish harvest only by special permit.

(aaa) Restricted Area means a growing area that has been classified by the Department as not meeting water quality criteria that would allow harvesting shellfish for direct marketing for human consumption. In a restricted area, shellfish may be harvested only by special permit and direct marketing of harvested shellfish is not allowed.

(bbb) Sanitary Survey Report means a written evaluation of all actual and potential pollution sources and environmental factors that affect shellfish growing area water quality.

(ccc) Sanitize means adequate treatment of food contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance and in substantially reducing the number of other microorganisms. Such treatment shall be safe and not adversely affect shellfish.

(ddd) Scheduled Depuration Process means the process that places shellfish harvested from conditionally restricted, restricted, or approved waters into a controlled aquatic environment selected by the processor and that has been demonstrated to the Department to effectively reduce the level of fecal coliform bacteria in live shellfish.

(eee) Seed means juvenile shellstock intended for growth to market size.

(fff) Shellfish means all edible species of oysters, clams, mussels, and scallops; either shucked or in the shell; fresh or fresh frozen; whole or in part, except that scallops shall be excluded when the final product is the adductor muscle only.

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

(hhh) Shellstock Shipper (SS) means a certified shipper who grows, harvests, buys, or sells shellstock. A shellstock shipper is not certified to shuck shellfish or repack shucked shellfish. A shellstock shipper may repackage shellstock or act as a reshipper.

(iii) Shucked Shellfish means shellfish that have been removed from their shells.

(jjj) Shucker-Packer (SP) means a certified shipper who shucks and packs shellfish. A shucker-packer may act as a repacker, shellstock shipper, or reshipper.

(kkk) State Shellfish Control Authority or Authority means the South Carolina Department of Health and Environmental Control or, if in reference to another state, the state agency having the primary authority to implement public health-related shellfish regulations.

(lll) Systematic Random Sampling is a field sampling and data analysis design that employs a preestablished sampling schedule and assumes that a statistically representative cross section of all meteorological, hydrographic, and/or other pollution events will be included in the data set.

(mmm) Triploid oyster means an oyster having three sets of homologous chromosomes.

(nnn) Vehicle means any truck, car, bus, trailer, railcar, aircraft, boat, ship, barge, dredge, or other means of conveyance by which shellfish is transported from one location to another.

(ooo) Vessel means any boat, ship, barge, dredge, or other type of watercraft used for the commercial harvest or transport of shellfish for human consumption.

(ppp) Wet Storage means storage of marketable shellfish in water after initial harvest.

3. Severability. In the event that any portion of these regulations is construed by a court of competent jurisdiction to be invalid, or otherwise unenforceable, such determination shall in no manner affect the remaining portions of these regulations, and they shall remain in effect, as if such invalid portions were not originally a part of these regulations.

S.C. Code Regs. § 61-47.A

Amended byState Register Volume 39, Issue No. 06, eff. 6/26/2015; State Register Volume 41, Issue No. 04, eff. 4/28/2017.