7 Del. Admin. Code § 7402-3.0

Current through Reigster Vol. 28, No. 6, December 1, 2024

Section 7402-3.0 - General Regulations, Water Quality and Classification, Harvesting, Tracking, Permitting, Handling and Shipping:

3.1 General Regulation Specifications:

3.1.1 DNREC Authority: These Regulations are adopted under authority of Title 7 of the Delaware Annotated Code. These Regulations shall be applied and enforced by DNREC in accordance with the specifications contained herein, and based on the interpretation of satisfactory compliance contained in the latest editions of the "NSSP Model Ordinance." Any person who neglects or fails to comply with any provision of these Regulations shall be subject to penalty.

3.1.1.1 These Regulations shall supersede and replace the Regulations Governing the Production, Handling, Processing, Transportation, and Sale Of Shellfish, and shall apply throughout the State of Delaware.

3.1.2 Unconstitutionality Clause: Should any section, paragraph, sentence, clause, or phrase of these regulations be declared unconstitutional or invalid for any reason the remainder of said regulations shall not be affected thereby.

3.1.3 Seizure of Shellfish: Shellfish which are determined to be adulterated, or which can not be identified as to source or place or origin, shall be seized, confiscated, and destroyed by DNREC. DNREC shall possess the authority to seize, confiscate, and destroy shellfish in the event of significant non-compliance with these regulations which could result in an eminent health hazard, as determined by DNREC.

3.1.4 Certification/Permitting/Sanitary Control: Not all persons/businesses handling shellfish shall necessarily be required to be permitted/certified by DNREC. However, persons/businesses which handle shellfish shall be permitted/certified by DNREC as per these regulations; and all persons or businesses which handle shellfish shall be under the sanitary control of DNREC. Certification, permits or written permission shall be non-transferable.

3.1.5 Emergency Closure of Shellfish Growing Areas: Emergency closure of shellfish growing areas to shellfish harvesting may be implemented by DNREC in response to the introduction of contaminants into shellfish growing waters, or in response to events which could affect the introduction of contaminants into shellfish growing waters, including; but not limited to: storms, flooding, sewage treatment plant failures, spills, boat wastes, or toxin-producing phytoplankton blooms (see Appendix 8).

3.1.6 HACCP (Hazard Analysis Critical Control Point): HACCP shall take effect on December 18, 1996. DNREC shall regulate under HACCP only those shellfish dealer/processors which are listed in the Interstate Certified Shellfish Shippers List, and which fall under HACCP as defined in Section 123.3 (k) (1) of the Federal law mandating HACCP, as interpreted by DNREC, and shall regulate only the portion or portions of said operation / physical facility which is/are utilized in the receipt, handling, processing, and shipping, of said shellfish, as defined herein.

3.2 Shellfish Growing Area Water Quality, Classification, and Harvesting:

3.2.1 Shellfish Growing Area Water Quality and Classification:

3.2.1.1 DNREC shall determine the size, configuration and classification of shellfish growing areas in Delaware.

3.2.1.2 DNREC shall determine the validity of all information which may have a bearing on the determination of the size, configuration, and classification of shellfish growing areas in Delaware.

3.2.1.3 DNREC shall classify Delaware's shellfish growing areas on the basis of the following:

3.2.1.3.1 Theoretical pollution loading including; but not limited to areas determined to be impacted by wet slip basins, as per the specifications contained in Appendix 11, thereby constituting an administrative closure;

3.2.1.3.2 Sanitary survey data constituting the documented presence of actual and potential point-source and non-point pollution sources; and

3.2.1.3.3 Bacteriological monitoring of shellfish growing waters and/or shellfish tissue (see Appendix 4).

3.2.1.4 Delaware's shellfish growing waters shall be classified as Approved, Prohibited, Seasonally Approved, Conditionally Approved, or Restricted.

3.2.1.5 Conformance with bacteriological shellfish water quality standards shall be based on a geometric mean of the most recent 30 samples per sample station.

3.2.1.6 Seasonally Approved and Conditionally Approved shellfish growing areas shall meet the following bacteriological standards on a seasonal and/or conditional basis depending upon the specifications of the classification/condition(s); and Approved shellfish growing areas shall meet the following bacteriological standards at all times:

3.2.1.6.1 Total coliform geometric mean MPN levels in shellfish growing waters shall not exceed 70 per 100 ml and not more than 10% or 90th percentile of the samples shall exceed an MPN of 230 per 100 ml for a 5-tube decimal dilution test, or an MPN of 330 per 100 ml for a 3-tube decimal dilution test.

AND/OR

3.2.1.6.2 Fecal coliform geometric mean MPN or membrane filter (MF) (membrane-Thermotolerant Escherichia coli [mTEC]) levels in shellfish growing waters shall not exceed 14 per 100 ml and not more than 10% or 90th percentile of the samples shall exceed an MPN of 43 per 100 ml for a 5-tube decimal dilution test, or an MPN of 49 per 100 ml for a 3-tube decimal dilution test, or an CFU of 31 per 100 ml for a MF (mTEC) test.

3.2.1.7 The standard for the Restricted classification of growing areas for purposes of relay or depuration of the shellfish therein shall meet the following bacteriological standards:

3.2.1.7.1 Total coliform geometric mean MPN level of the water sample results shall not exceed 700 per 100 ml and not more than 10% or 90th percentile of the samples shall exceed an MPN of 3,300 per 100 ml using a 3-tube decimal dilution test.

3.2.1.7.2 Fecal coliform geometric mean MPN or MF (mTEC) of the water sample results shall not exceed 88 per 100 ml and not more than 10% or 90th percentile of the samples shall exceed an MPN of 260 MPN per 100 ml for a 5-tube decimal dilution test, or an MPN of 300 per 100 ml for a 3-tube decimal dilution test, or an CFU of 163 per 100 ml for a MF (mTEC) test.

3.2.2 Shellfish Harvesting and Tagging:

3.2.2.1 Shellfish harvesting shall not be allowed in the following areas:

3.2.2.1.1 Shellfish growing areas classified as Prohibited, unless for scientific research purposes, and only with written permission of DNREC; or in accordance with 3.2.2.2.4.

3.2.2.1.2 Shellfish growing areas classified as Seasonally Approved or Conditionally Approved in accordance with conditions stipulated in Appendix 3.

3.2.2.1.3 Shellfish growing areas not classified, and for which there are insufficient data supporting a harvest.

3.2.2.2 Shellfish may be harvested from the following areas under the conditions listed herein and/or in the Appendices:

3.2.2.2.1 In shellfish growing areas classified as Approved;

3.2.2.2.2 Shellfish growing areas classified as Seasonally Approved in accordance with conditions stipulated in Appendix 3;

3.2.2.2.3 Shellfish growing areas classified as Restricted.

3.2.2.2.4 Seed may be grown in waters classified as Prohibited and transported to a lease in a shellfish growing area classified as Approved, Conditionally Approved or Seasonally Approved as long as the seed is removed from waters classified as Prohibited before the maximum seed size is exceeded.

3.2.2.2.4.1 The maximum seed size for oysters is 25 mm and the maximum seed size for clams is 15 mm.

3.2.2.2.4.2 Oysters or clams that are cultured in aquaculture operations in waters classified as Prohibited and exceed the maximum seed size shall be determined to be adulterated and shall be seized, confiscated, and destroyed by DNREC.

3.2.2.3 Harvesters shall place tags on individual units of shellstock, recognizing that individual bags or a bulk landing of shellstock may constitute an individual unit of shellstock. All harvester tags shall meet the requirements specified in Appendix 10.

3.3 Permitting of Shellfish Dealer/Processors:

3.3.1 Permit Issuance Parameters:

3.3.1.1 Applications for permits to operate as shellfish dealer/processors shall be made on permit applications provided by DNREC. The following shellfish handlers shall be required to be permitted/certified by DNREC in order to engage in the procurement and sale of shellfish:

3.3.1.1.1 All interstate shellfish dealer/processors;

3.3.1.1.2 Intrastate shellfish dealer/processors;

3.3.1.1.3 Shellfish wholesalers;

3.3.1.1.4 Shellfish retailers which procure shellfish from non-certified sources;

3.3.1.1.5 Shellfish harvesters, engaged in:

3.3.1.1.5.1 Selling/shipping shellfish directly to non-certified shellfish retailers or to final consumers;

3.3.1.1.5.2 Owners of "buy boats" and "buy trucks;" and

3.3.1.1.5.3 Harvesting of shellfish for delivery to a depuration plant and/or for relaying.2

2Persons harvesting shellfish from waters classified as other-than-Approved for delivery to a depuration plant and persons engaged in relaying shall submit operational specifications for said activities to DNREC prior to commencing operations, and shall have received a permit or written permission from DNREC to harvest shellfish from waters classified as other-than-Approved prior to commencing such operations. Additional permits may be required by the DNREC Division of Fish and Wildlife.

3.3.1.2 Shellfish retailers shall not be required to be permitted/certified unless shellfish are procured from a non-certified source. 2

3.3.1.3 Shellfish handlers requiring a permit/certification shall not operate until and unless a permit/certification has been issued by DNREC. Such permits shall expire on the 31st day of March of each year. Permits shall not be transferable. No permit will be issued unless an application is made in writing upon forms supplied by DNREC. Prior to the physical and/or operational alteration of an existing facility and/or prior to initial commencement of shellfish processing operations shellfish dealer/processors shall:

3.3.1.3.1 Submit construction and operational specs. to DNREC;

3.3.1.3.2 Receive approval of the plans and operational specifications from DNREC;

3.3.1.3.3 Submit to an inspection of their plant/operation by DNREC; and

3.3.1.3.4 Shall be found to be in satisfactory compliance with these Regulations, at the discretion of DNREC.

3.3.1.4 DNREC shall have the authority to immediately revoke shellfish dealer/processor permits based on the existence of an eminent health hazard and/or significant and/or chronic non-compliance with these Regulations.

3.3.1.4.1 Delaware Shellfish Dealer/Processors shall be considered to be certified only if a current numbered license or permit to operate as an intrastate or interstate shellfish dealer/processor has been issued by DNREC, and the operation is in significant compliance with these regulations, as determined by DNREC.

3.3.2 Permit Specifications and Inspection Frequency:

3.3.2.1 The permits listed below shall be issued as interstate shellfish dealer/processor permits, OR intrastate shellfish dealer/processor permits; EXCEPT intrastate shellfish retailer permits which are issued as intrastate permits only. This includes all wholesalers, which shall also apply to harvesters which engage in the activities defined below and elsewhere in these Regulations:

3.3.2.1.1 Shellstock Shipper (SS) permit: Such permits may be issued to shellfish dealer/processors which ship shellfish. Said shellfish may be grown and/or harvested by the shipper in accordance with these Regulations and/or procured from another source. Shellstock shippers may procure shellfish directly from licensed Delaware shellfish harvesters, and may sell shellfish to other certified shellfish dealer/processors in and outside of Delaware and to the final consumer. Shellstock shippers shall not act as shucker-packers, repackers, or depuration-processors. Minimum Inspection Frequency: Twice/year.

3.3.2.1.2 Shucker-Packer (SP) permits: Such permits may be issued to shellfish dealer/processors which shuck and pack shellfish. Shucker-packers may act as shellstock-shippers and repackers. Shucker-packers shall not act as depuration-processors. Minimum Inspection Frequency: Once/month when operating, and at least four times per year, total, unless the facility is open less than four months per year.

3.3.2.1.3 Repackers (RP) permit: Such permits may be issued to shellfish dealer/processors other than the original certified shucker-packer which repack and ship shucked shellfish into other containers. Such permit-holders must generally meet more requirements than shellstock-shippers; however, not generally the equipment requirements of a shucker-packer. Repackers may act as shellstock-shippers. Repackers shall not act as shucker-packers or depuration-processors. Minimum Inspection Frequency: Once/month when operating, and at least four times per year, total, unless the facility is open less than four months per year.

3.3.2.1.4 Depuration Processor (DP) permit: Such permits shall be issued to shellfish dealer/processors which receive or harvest shellstock from approved sources, or as per criteria listed in the depuration portions of Section IV of these Regulations, and which subjects said shellfish to an approved depuration process, thereby rendering the shellfish as approved and fit for human consumption. A depuration-processor may act as a shellstock-shipper, or repacker. Minimum Inspection Frequency: Once/month when operating, and at least four times per year, total, unless the facility is open less than four months per year. twice/year.

3.3.2.1.5 Intrastate Shellfish Retailer permit: Such permits may be issued to persons/businesses located in Delaware, which may include vehicles registered only in Delaware and/or permanent structures from which shellfish are sold only to the final consumer. The intention of this permit is to provide sanitary control of shellfish not necessarily procured from a certified shellfish dealer/processor. Minimum Inspection Frequency: twice/year.

3.4 Shellfish Handling and Shipping Parameters:

3.4.1 Importation/Exportation:

3.4.1.1 Only shellfish from approved sources shall be imported into Delaware.

3.4.1.2 Only shellfish which have been handled by certified interstate shellfish dealer/processors shall be exported from Delaware.

3.4.1.3 Intrastate Delaware shellfish dealer/processors shall not sell/ship shellfish out of Delaware; and shellfish handled by intrastate Delaware shellfish dealer/processors shall not be made available for sale outside of Delaware.

3.4.1.4 Shellfish requiring depuration or relaying shall be sold/shipped only within Delaware to certified depuration-processors, or shall be shipped out of Delaware only under the provisions of interstate memoranda of agreement (MOAs) relating to a specific harvest/depuration or harvest/relaying operation by persons permitted to harvest shellfish under these restrictions, as established in writing by DNREC and the cooperating state. All other handling of shellfish from Prohibited waters and from Seasonally Approved or Conditionally Approved waters when the direct harvest of said shellfish is prohibited by these Regulations is prohibited.

3.4.2 Marketing to the Final Consumer: 3

3.4.2.1 Only shellfish from approved sources shall be sold/transferred in Delaware to the final consumer.

3.4.2.2 Certified interstate and intrastate shellfish dealer/processors may sell/transfer shellfish directly to the final consumer.

3.4.2.3 Certified interstate and intrastate shellfish dealer/processors may sell/transfer shellfish directly to non-certified shellfish retailers.

3.4.3 Sale/Shipping Between Shellfish Dealer/Processors.

3.4.3.1 Certified intrastate shellfish dealer/processors may sell/transfer shellfish to other intrastate shellfish dealer/processors.

3.4.3.2 Certified interstate shellfish dealer/processors may sell/transfer shellfish to other certified interstate shellfish dealer/processors or to Delaware intrastate shellfish dealer/processors.

3.4.3.3 Certified interstate and intrastate shellfish dealer/processors shall not sell/transfer shellfish to commercial establishments which are in critical or significant violation of these regulations at the discretion of DNREC.

7 Del. Admin. Code § 7402-3.0

22 DE Reg. 863 (4/1/2019)
25 DE Reg. 726 (1/1/2022) (Final)