Current through Register Vol. 28, No. 3, September 1, 2024
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.