reglab/statecodes huggingface dataset:
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.10 - Collection of cord blood

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The cord blood
				service shall have policies and procedures for acceptable collection methods.
				Collections of cord blood shall be initiated within 10 minutes of the birth of the
				infant.
(b) The collection method shall:
1. Ensure the safety of the birth mother and the
				infant;
2. Ensure the positive
				identification of the donor (infant) by verifying the identification of the mother
				and the associated placenta;
3. Ensure
				retention of adequate sterility and stem cell viability;
4. Not result in any deviation from normal
				obstetric procedures;
5. Conform to
				accepted standards of asepsis; and
6. Be
				performed by the obstetrician or allied health care professional, responsible for
				the delivery of the infant, for in utero (prior to placental delivery) collection
				procedure.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.11 - Processing

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The medical director
				of the facility shall approve HPC processing procedures in writing.
(b) The facility shall use methods known to result
				in acceptable viability, recovery, and sterility.
(c) Cryopreservation, manipulation or other
				processing procedures shall be performed as per the SOP that are well established in
				the medical literature or, if experimental, shall be approved by an institutional
				review board.
(d) Aseptic techniques
				shall be used to prevent bacterial contamination.
(e) Appropriate quality control tests and measures
				shall be in place to demonstrate adequate targeted cell yields, microbial sterility
				and viability of the product.
(f) After
				processing, the product shall be stored at acceptable temperatures in accordance
				with 8:8-13.16.
(g) Relevant information that can affect the
				safety, efficacy and potency of the product shall be communicated to the recipient's
				physician.
(h) The licensee shall ensure
				that the HPC are not exposed to gamma irradiation, inappropriate temperatures and
				other conditions known to compromise the safety or the efficacy of the HPC
				unit.
(i) The facility shall maintain
				records of:
1. Lot numbers and expiration dates of
				all disposables and reagents used in processing;
2. Processing procedures for each unit and the
				identity of the person performing each procedure; and
3. Processing tests performed on each unit prior
				to cryopreservation, which shall include CD34 or a comparable analysis, total
				nucleated cell count, percent viability, ABO group, Rh type, final HPC unit volume
				and microbial cultures.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.12 - Cryopreservation

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Cryopreservation
				methods known to preserve HPC viability, recovery, and potency shall be
				used.
(b) The following records shall be
				maintained for each cryopreserved unit:
1.
				Starting product and volume;
2. Relevant
				cell count;
3. Cell viability;
4. Name, volume and concentration of
				cryoprotectant, anticoagulants and/or additives;
5. Cooling record from controlled-rate freezing,
				if applicable;
6. Endpoint temperature
				of cooling; and
7. Location of HPC and
				stored test aliquots.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.13 - Testing of donors

Current through Register Vol. 56, No. 14, July 15, 2024
(a) For products
				originating in the United States, all required tests on the prospective donors prior
				or at the time of the donation shall be performed by a New Jersey licensed
				laboratory/blood bank and/or CMS certified laboratory. This information shall be
				available to the recipient's physician and the cell processing laboratory.
(b) All allogeneic donors are subject to the
				testing required by the Food and Drug Administration (FDA).
(c) The blood bank director shall communicate
				abnormal results in writing to the donor.
(d) Prior to the collection/transplantation, the
				transplant physician shall review the results to determine compatibility.
(e) Current results shall be compared with
				previous results, if any, for ABO group, Rh type and HLA type. Any discrepancies
				shall be resolved prior to issue of the HPC.
(f) The following tests shall be performed:
1. ABO group and Rh type;
2. Major histocompatibility antigens, HLA-A; -B
				and -DR (For allogeneic donors only);
3.
				Tests for unexpected antibodies to red cell antigens. Serum or plasma from donors
				with a history of transfusion or pregnancy shall be tested for unexpected antibodies
				to red cell antigens using methods that demonstrate clinically significant red cell
				antibodies within 30 days of donation. (For allogeneic donors only); and
4. Required infectious disease testing for
				allogeneic and autologous transplantation include a serologic test for syphilis
				(STS); Hepatitis B Surface Antigen (HBsAg); antibody to Hepatitis C Virus (HCV);
				Hepatitis B Core Antibody (HBcAb); antibody to Human Immunodeficiency Virus type 1
				(HIV-1) and type 2 (HIV-2); antibody to Human T-Lymphotropic Viruses I/II (HTLV
				I/II); Cytomegalovirus (CMV) for allogeneic only, and any other tests licensed by
				the FDA for donor testing within 30 days of availability.
i. This testing is waivable only in accordance
				with 21 CFR Part 1271 -Human Cells, Tissues, and Cellular and Tissue-Based Products,
				incorporated herein by reference, as amended and supplemented.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.14 - Labeling

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The labeling for HPC
				shall be in accordance with the
				8:8-8.8 and AABB standards as amended
				and supplemented.
(b) There shall be
				documented evidence that the label used can withstand the conditions under which the
				specimen is stored.
(c) During
				intermediate processing steps, the container label shall contain at least the name
				of the component and the unique alphanumeric identifier.
(d) Prior to storage, issue, or transport, the
				container label(s) shall have at least the following information:
1. The name of the component, the date of
				collection, the alphanumeric identifiers, the recipient's name, if known, the
				collection facility and when applicable the donor registry's identifier, the
				approximate volume of the component, the names and volumes of the anticoagulants and
				additives, any manipulation process, the recommended storage temperature, if
				applicable, the expiration date and time or the statement "No expiration date", and
				the ABO group and Rh type of the donor; and
2. A biohazard label if the donor has tested
				confirmed positive for infection with syphilis, Hepatitis B surface antigen,
				Hepatitis B core antibody, Hepatitis C virus antibody, anti-HIV-1, anti-HIV-2 and
				antibody to Human T-cell lymphotropic virus types I and II.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.15 - Expiration dates

Current through Register Vol. 56, No. 14, July 15, 2024
Expiration dates for HPC shall be in accordance with the FDA
				  regulations and the AABB Standards, as amended or supplemented.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.16 - Storage

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The storage of HPC
				shall be in accordance with
				8:8-11.3.
(b) HPC stored in a liquid state shall be
				maintained at a temperature and for a period of time specified in a written
				procedure approved by the laboratory director. Appropriate documentation shall be
				available to support these specifications.
(c) HPC stored in a frozen state shall be within a
				temperature range as determined to be appropriate for the cryoprotectant
				used.
(d) For HPC components immersed in
				liquid nitrogen, written procedure to minimize the risk of microbial cross
				contamination of components shall be defined in the SOP and followed.
(e) The storage device shall be located in a
				secure area with available locking capability for use.
(f) Liquid nitrogen freezers shall have a
				mechanism to ensure that levels of nitrogen are maintained.
(g) An inventory control system shall be
				operational to locate any HPC component or quality control vial from that component,
				if available.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.17 - Issue

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A blood
				transplantation request form indicating the recipient's name, traceable
				identification number, and ABO group and Rh type shall be completed for each unit of
				HPC.
(b) A label or tag with the
				appropriate information to identify the HPC unit with the intended recipient shall
				be attached to the HPC container before its release from the HPC blood bank or
				laboratory for transplantation.
(c) At
				the time the HPC is released from the blood bank for transplantation within the
				facility, the person receiving the HPC shall present a written request with
				sufficient information for the positive identification of the recipient. When the
				HPC are issued within the facility, the technologist who issues the HPC shall
				perform an identification check along with the person picking up the HPC. This
				identification check shall involve active participation by both individuals in a
				review of the identifying information on the HPC container and the requisition slip.
				At a minimum the recipient's first and last names, traceable identification number,
				the HPC requested, and the date of transplantation shall be included. The blood bank
				shall write the unit number of the issued HPC on the request slip. When the HPC are
				issued outside the facility, the technologist who packages the HPC for shipping
				shall perform an identification check. The review process shall be
				documented.
(d) There shall be SOP for
				the management of abnormal appearance, broken container and any variance from
				acceptable ranges.
(e) A duly licensed
				physician shall request the release of HPC preparations from storage in
				writing.
(f) The identity of the
				intended recipient, the location (hospital) where the product is to be administered
				and the shipping date shall be documented.
(g) The following information shall also be
				documented and records shall be maintained indicating:
1. The type of HPC;
2. The alphanumeric identification for each
				collection;
3. The date and time of the
				expected infusion;
4. The recipient name
				and identification number;
5. The
				facility and person to whom the cells were dispensed; and
6. The integrity of the container and
				label.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.18 - Reissue

Current through Register Vol. 56, No. 14, July 15, 2024
(a) There shall be SOP
				for return to inventory of HPC issued for infusion and subsequently not infused.
				This shall include verification of the integrity of the container and verification
				that the HPC was maintained under appropriate storage conditions.
(b) The SOP shall address the need for
				authorization by the medical director or laboratory director or their designee, in
				consultation with the patient's transplant physician, to accept components for
				return and shall stipulate criteria for disposition of the component including
				possible reissue or discard.
(c)
				Documentation of the events requiring return, the results of inspection upon return,
				and subsequent action to insure component safety and viability shall be maintained
				in the blood bank/laboratory record.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.19 - Packaging and transportation

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The packaging and
				transportation of HPC shall follow this chapter and the AABB Standards.
(b) Prior to transportation, each container shall
				be inspected to ensure the container is intact and the label is complete, secure,
				and legible.
(c) HPC in transit to
				outside facilities shall be:
1. Packaged and
				shipped according to blood bank policies to ensure product integrity and maintenance
				of product temperature within limits set by the licensee;
2. Temperatures shall be recorded at the beginning
				and end of transport to document maintenance of acceptable temperatures set by the
				licensee;
3. Shipped using appropriate
				modes of transportation to ensure delivery to meet the urgency of the request for
				HPC;
4. Labeled prominently to:
i. Identify the contents with industry
				nomenclature specific to the product;
ii. Describe the contents, the packing agent, if
				any, and any precautions necessary in handling such contents; and
iii. Contain the name, address, and 24-hour
				telephone numbers of the person or entity to contact in the event that the container
				is found leaking or damaged, or is misdirected; and
5. Used immediately upon arrival or stored in a
				temperature environment specified in the SOP until thawed for use.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.20 - Administration

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Identification of
				the recipient and the HPC container shall be as follows:
1. Each transplantation service shall have a
				written procedure for the positive identification of the recipient and the HPC
				container.
2. At the bedside,
				immediately prior to transplantation, two qualified individuals (as specified in the
				SOP whose qualifications are determined and verified by the medical institution or
				the transplantation facility in consultation with the medical director) shall
				simultaneously check and match all information identifying the container with the
				identifying information on the person of the intended recipient and the request
				slip. If the information does not match, the initiation of transplantation shall be
				suspended until the discrepancy is adequately investigated and resolved.
3. At the bedside, immediately after the
				identifying information in
				8:8-10.2 is matched, and before the
				transplantation is initiated, the two qualified individuals that checked this
				information shall sign the transplantation form to attest that this information was
				checked and that it matched.
4. All
				identification attached to the container shall remain attached at least until the
				transplantation has been completed.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 9 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES › Subchapter 1 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES (CHAPTER 5 OF THE STATE SANITARY CODE) › Section 8:9-1.1 - Disposition of bodies generally; emergencies

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The person or
				persons responsible for the burial or cremation or other lawful disposition of a
				dead human body shall not allow the same to remain unburied or uncremated in the
				State of New Jersey for a period longer than 48 hours unless:
1. The body is embalmed by arterial and cavity
				injection or kept refrigerated at 45 degrees Fahrenheit or below; or
2. The Commissioner of Health authorizes an
				exemption to or waiver of this requirement, subject to conditions the Commissioner
				might prescribe, during the existence of an emergency declared by the
				Governor.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 9 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES › Subchapter 1 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES (CHAPTER 5 OF THE STATE SANITARY CODE) › Section 8:9-1.2 - Reserved

Current through Register Vol. 56, No. 14, July 15, 2024
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 9 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES › Subchapter 1 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES (CHAPTER 5 OF THE STATE SANITARY CODE) › Section 8:9-1.3 - Use of precautions in the preparation or handling of a dead body and disinterred remains

Current through Register Vol. 56, No. 14, July 15, 2024
(a) As used in this
				chapter, "Isolation Precautions" means Siegel JD, Rhinehart E, Jackson M, Chiarello
				L, and the Healthcare Infection Control Practices Advisory Committee, 2007 Guideline
				for Isolation Precautions: Preventing Transmission of Infectious Agents in
				Healthcare Settings (last update June 2019), incorporated herein by reference, as
				amended and supplemented, available at
http://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf
and at
http://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html
.
1. As used in the Isolation Precautions, for
				purposes of this chapter, the term "patient" shall be construed to mean "dead body"
				or "disinterred remains," as applicable.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 9 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES › Subchapter 1 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES (CHAPTER 5 OF THE STATE SANITARY CODE) › Section 8:9-1.4 through 8:9-1.5 - Reserved

Current through Register Vol. 56, No. 14, July 15, 2024
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 9 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES › Subchapter 1 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES (CHAPTER 5 OF THE STATE SANITARY CODE) › Section 8:9-1.6 - Transportation of certain bodies in sealed caskets

Current through Register Vol. 56, No. 14, July 15, 2024
A person shall not convey or aid in conveying to a common carrier
				  to be transported across or within this State, and a common carrier shall not accept
				  for transportation or transport into or within this State, the body of a person who
				  has died of any of the following diseases: smallpox, Asiatic cholera, yellow fever,
				  typhus fever, or bubonic plague unless the body is enclosed in a hermetically sealed
				  casket and a license for such transportation has been first obtained in writing from
				  the Department of Health containing the information in the form provided at chapter
				  Appendix A, incorporated herein by reference.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 9 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES › Subchapter 1 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES (CHAPTER 5 OF THE STATE SANITARY CODE) › Section 8:9-1.7 - Transportation of bodies generally

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A human body dead
				from causes other than those included at N.J.A.C. 8:9-1.6shall not be transported by
				a common carrier unless embalmed by arterial and cavity injection and enclosed in a
				leakproof casket or box, provided that embalming shall not be required if
				destination can be reached within 24 hours after death.
1. This subsection does not apply to disinterred
				bodies.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 9 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES › Subchapter 1 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES (CHAPTER 5 OF THE STATE SANITARY CODE) › Section 8:9-1.8 - Necessity of transit permit

Current through Register Vol. 56, No. 14, July 15, 2024
A dead human body shall not be transported out of the State by
				  common carrier unless accompanied by a transit permit containing the information in
				  the form provided at Appendix A.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 9 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES › Subchapter 1 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES (CHAPTER 5 OF THE STATE SANITARY CODE) › Section 8:9-1.9 - Disinterments; when allowed; permits

Current through Register Vol. 56, No. 14, July 15, 2024
A dead human body shall not be disinterred or removed from any
				  grave, tomb, or burial place except by direction of a competent court of this State,
				  or upon permit being given therefor by the local board of health having jurisdiction
				  in the locality where the body is interred or entombed in the form provided at
				  chapter Appendix B, incorporated herein by reference, provided, however, that no
				  disinterment permit shall be required in the situations described at N.J.S.A.
				  45:27-23b and, if applicable to the entity conducting the disinterment or the
				  location from which the disinterment is to occur, as provided at N.J.A.C.
				  13:44J-8.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 9 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES › Subchapter 1 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES (CHAPTER 5 OF THE STATE SANITARY CODE) › Section 8:9-1.10 - Acceptance of disinterred body for transportation

Current through Register Vol. 56, No. 14, July 15, 2024
A common carrier shall not accept for transportation or transport
				  a disinterred human body unless the body is enclosed in a metal or metal-lined case
				  sealed by heat or by use of a metal or rubber gasket, provided that a metal or
				  metal-lined sealed case shall not be required for a body from which no fluid or
				  offensive odor emanates.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 9 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES › Subchapter 1 - PREPARATION, HANDLING, TRANSPORTATION, BURIAL AND DISINTERMENT OF DEAD HUMAN BODIES (CHAPTER 5 OF THE STATE SANITARY CODE) › Section 8:9-1.11 - Disposal for unclaimed cremains

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The purpose of this
				section is to establish general guidelines for the purpose of assisting funeral
				directors in their efforts to dispose of cremains which have been left with the
				funeral director for at least one year after cremation and after the funeral
				director has made a diligent effort, pursuant to
				N.J.S.A.
				26:7-18.2 to identify, locate, and notify a
				relative or friend of the deceased.
(b)
				Any person who has compiled with the provisions of
				N.J.S.A.
				26:7-18.2 may dispose of the cremains of a dead
				human body by scattering same at sea or by interring same on land in a dignified
				manner.
(c) A certified letter, return
				receipt requested, mailed to the person who authorized the cremation shall be
				certification satisfactory to the Commissioner.
(d) No claims shall be made by a person against
				any person who invokes the provisions of
				N.J.S.A.
				26:7-18.2 or this regulation, nor shall any
				liability be attendant to such invocation.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 13 - SHELLFISH › Subchapter 1 - SANITATION, HANDLING, SHIPPING AND SHUCKING OF SHELLFISH › Section 8:13-1.1 - Purpose and scope

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The purpose of this
				subchapter is to provide uniform sanitary standards based upon the National
				Shellfish Sanitation Program Model Ordinance, which was developed through a
				Memorandum of Understanding between the U.S. Food and Drug Administration and the
				Interstate Shellfish Sanitation Conference. A full text of the current edition of
				the Model Ordinance incorporated herein by reference is available by contacting the
				U.S. Food and Drug Administration, Baltimore District Office at 6000 Metro Drive,
				Baltimore, MD 21201-3215. Copies can also be obtained through the Interstate
				Shellfish Sanitation Conference web page at
http://www.issc.org
.
(b) The scope of this subchapter is to establish
				the minimum sanitation and recordkeeping requirements for the harvesting, shipping,
				reshipping of shellstock, and shucking and repacking of raw molluscan shellfish to
				include clams, oysters, mussels, and whole scallops shipped in both interstate and
				intrastate commerce.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 13 - SHELLFISH › Subchapter 1 - SANITATION, HANDLING, SHIPPING AND SHUCKING OF SHELLFISH › Section 8:13-1.2 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
In addition to definitions contained in the "Definitions" section
				  of the Model Ordinance, the following words and terms, when used in this chapter,
				  shall have the following meaning unless the context clearly indicates
				  otherwise.
"DEP" means the New Jersey Department of Environmental
				  Protection.
"Department" means the New Jersey Department of Health.
"FDA" means the U.S. Food and Drug Administration.
"ISSC" means the Interstate Shellfish Sanitation
				  Conference.
"Model Ordinance" means Chapter II of the National Shellfish
				  Sanitation Program Guide for the Control of Molluscan Shellfish of the ISSC and the
				  U.S. Department of Health and Human Services; Public Health Services; Food and Drug
				  Administration, 2003 Revision, incorporated herein by reference as amended and
				  supplemented, subject to
				  8:13-1.4, available by writing to the
				  ISSC, 209-2 Dawson Road, Columbia, SC 29223-1740, and available for download at
				  at.
"Person" means and includes an individual, firm, corporation,
				  association, society, partnership, and their agents or employees.
"Retail" means a retail sale which is defined as any sale to the
				  ultimate consumer or his/her family, or to a person who will not sell the
				  product.
"Wholesale" means any sale to any other person than the ultimate
				  consumer or his or her family.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 13 - SHELLFISH › Subchapter 1 - SANITATION, HANDLING, SHIPPING AND SHUCKING OF SHELLFISH › Section 8:13-1.3 - Prohibited acts

Current through Register Vol. 56, No. 14, July 15, 2024
(a) No person shall
				sell, offer for sale or have in his or her possession with intent to sell without a
				permit from the DEP any shellfish which have been taken from a place classified as
				"Prohibited" or otherwise closed to harvesting by the DEP pursuant to N.J.A.C. 7:12
				(58:24-1 ) or from a place condemned by
				authorities having supervision at the point of origin of the shellfish without
				permission from such authorities and/or the DEP.
(b) No person shall engage in the wholesale
				handling of shellfish, operate or conduct an establishment for the shucking,
				repacking or wet storage of shellfish without a certificate issued by the
				Department, except that shellstock harvested by a harvester in accordance with the
				provisions of these rules may be transported and sold to a certified
				dealer.
(c) No person shall receive or
				accept any shipment of shellfish for shucking, repacking, shipping or sale unless
				the New Jersey dealer holds a current certificate issued pursuant to
				8:13-1.5 and holds a current license
				issued pursuant to
				24:15-13. Shellfish originating from
				out-of-State sources shall be received from states or countries that have received
				the endorsement of the FDA and the dealer shall be listed in the current Interstate
				Certified Shellfish Shippers List published by the FDA.
(d) No retailer may repack or shuck shellfish
				without a certificate from the Department unless it is done on order from the
				consumer.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 13 - SHELLFISH › Subchapter 1 - SANITATION, HANDLING, SHIPPING AND SHUCKING OF SHELLFISH › Section 8:13-1.4 - Model Ordinance requirements

Current through Register Vol. 56, No. 14, July 15, 2024
Persons engaged in the handling, shucking, repacking, depuration,
				  wet storage, and shipping of shellfish shall comply with the provisions of the Model
				  Ordinance, except Subchapters I through VI, VIII @ .01 and .02C, and XV which are
				  not being adopted and incorporated herein by reference.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 13 - SHELLFISH › Subchapter 1 - SANITATION, HANDLING, SHIPPING AND SHUCKING OF SHELLFISH › Section 8:13-1.5 - Shellfish certificates

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Any person desiring
				to engage or continue to engage in the wholesale handling, shipping, shucking,
				repacking, wet storage, or depurating of shellfish shall make application in writing
				on forms supplied by the Department, entitled "Application for Certification to
				Handle Oysters, Clams or Mussels." Applicants shall provide all identifying
				information required on the form including name, mailing address, and telephone
				number of the owner of the business, the location address of the establishment,
				trade name, name and address of corporate officers, name and county of registered
				agent if applicable, the type and source of shellfish to be handled, the type of
				operations to be carried out, and whether shellfish will be sold in interstate
				commerce.
(b) Upon receipt of such
				applications and upon approval of the facilities and sanitary condition of the
				establishment or area, and compliance by the applicant with other provisions of the
				law and regulations, a certificate shall be issued for such operation by the
				Department.
(c) All shellfish
				certificates shall expire on June 30 of each year. A renewal application entitled
				"Application for Certification to Handle Oysters, Clams or Mussels" shall be
				completed on forms supplied by the Department with the information required in (a)
				above and returned to the Department no later than June 30 of the application year.
				In no case shall a shellfish firm operate without a valid certificate issued by the
				Department. The certification shall not be transferable with respect to persons or
				locations. If the certificate operator has ceased operations, the discontinuance of
				operations statement shall be completed and returned to the Department.
(d) Current certificates shall be kept on file and
				open to inspection by representatives of the State or local health department.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 13 - SHELLFISH › Subchapter 1 - SANITATION, HANDLING, SHIPPING AND SHUCKING OF SHELLFISH › Section 8:13-1.6 - Suspension, revocation or nonrenewal of certification

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Upon evidence duly
				ascertained by the Department or any local board of health that the holder of the
				certificate has, or is currently, violating any rule, regulation or statute
				applicable to wholesale shellfish operations, the Department shall, upon hearing and
				proof of allegation, suspend, revoke or refuse to renew any such certificate. The
				hearing shall be conducted pursuant to the provisions of the Administrative
				Procedure Act, 52:14B-1 et seq., and the Uniform
				Administrative Procedure Rules, N.J.A.C. 1:1.
(b) When in its determination that the protection
				of the public health warrants such action, the Department may suspend any
				certification pending hearing. In no case shall a shellfish facility operate as such
				while suspended. Upon written request, the certificate holder will be granted an
				expedited hearing conducted pursuant to the Administrative Procedure Act,
				52:14B-1 et seq. and the Uniform
				Administrative Procedure Rules, N.J.A.C. 1.1.
(c) A certificate to operate a shellfish facility
				shall not be renewed or restored until the Department determines that all
				requirements of this subchapter and any other applicable rules and regulations have
				been satisfied.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 13 - SHELLFISH › Subchapter 1 - SANITATION, HANDLING, SHIPPING AND SHUCKING OF SHELLFISH › Section 8:13-1.7 - Oyster temperature control

Current through Register Vol. 56, No. 14, July 15, 2024
(a) From June 1 through
				September 15 of each year, a harvester shall implement the following mechanism
				onboard a vessel to control the temperature of oysters immediately following
				harvest:
1. The vessel shall have tarping
				installed that shall be used on a constant basis when the harvesting of oysters
				begins until unloading begins at the dockside.
2. The tarping shall:
i. Remain in place and withstand typical operating
				and weather conditions;
ii. Provide a
				minimum of one foot clearance above and prevent direct sunlight on oysters held in
				cages or other holding devices;
iii.
				Extend a minimum of one foot beyond the perimeter of oyster cages or other holding
				devices; and
iv. Be maintained in
				sanitary and operable condition.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 13 - SHELLFISH › Subchapter 2 - DEPURATION OF HARD SHELL AND SOFT SHELL CLAMS › Section 8:13-2.2 - General requirements

Current through Register Vol. 56, No. 14, July 15, 2024
Any person engaged in the depuration of clams shall conform to
				  the rules governing sanitation, handling, shipping and shucking of shellfish
				  promulgated under this chapter, Title 24 of the Revised Statutes, and 21 CFR Part
				  123.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 13 - SHELLFISH › Subchapter 2 - DEPURATION OF HARD SHELL AND SOFT SHELL CLAMS › Section 8:13-2.3 - Prohibited acts

Current through Register Vol. 56, No. 14, July 15, 2024
No person shall distribute or sell, offer for sale or have in his
				  or her possession with the intent to distribute or sell any clams which have been
				  harvested from special restricted waters and have not been depurated for at least 48
				  hours and which do not meet the bacteriological standards set forth under
				  8:13-2.21. Clams shall be depurated for
				  a minimum of 48 hours, but not longer than 72 hours. Depuration shall be restricted
				  to clams of the species approved by the Department. Only clams harvested from waters
				  approved for this purpose by the Department of Environmental Protection pursuant to
				  58:24-1 et seq. may be depurated. Clams
				  from other sources may not be stored on the premises of the depuration plant. The
				  depuration plant shall be used for no purpose other than the depuration of clams.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 13 - SHELLFISH › Subchapter 2 - DEPURATION OF HARD SHELL AND SOFT SHELL CLAMS › Section 8:13-2.4 - Hard and Soft Shell Clam Depuration Program

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Any person(s)
				wishing to construct and/or operate a soft or hard shell clam depuration plant shall
				submit to the SRRSC a detailed proposal providing all pertinent information
				concerning the proposed plant on applications provided by the SRRSC.
1. A detailed set of construction plans shall
				accompany the application.
2. All
				depuration plant proposals shall be forwarded to:
Public Health and Food Protection Program
Consumer, Environmental and Occupational Health Service
Public Health Services Branch
New Jersey Department of Health
PO Box 369
Trenton, NJ 08625-0369
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 13 - SHELLFISH › Subchapter 2 - DEPURATION OF HARD SHELL AND SOFT SHELL CLAMS › Section 8:13-2.5 - Provisional certificate requirements

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Upon approval by the
				SRRSC to initiate construction of a depuration plant, the issuance of a provisional
				shellfish certificate to operate a depuration plant on an interim basis until the
				final verification studies are completed is contingent upon the following:
1. Submission of a completed shellfish certificate
				application as required under
				8:13-1.5 and a food/cosmetic
				establishment license application with the applicable fee as required under
				24:15-13 and N.J.A.C. 8:21-9;
2. Approval of construction plans;
3. Approval of the depuration system including the
				clam processing containers as specified under
				8:13-2.14;
4. Completion of plant construction;
5. Completion of a preoperational inspection
				conducted by the Department indicating substantial compliance with all of the
				provisions of this subchapter;
6. Filing
				the necessary permit applications required under N.J.A.C. 7:12. The Department must
				receive verification from DEP that the applicant meets the DEP regulatory
				provisions;
7. A written HACCP plan and
				depuration plant operations manual, which includes the scheduled depuration process,
				shall be submitted for approval to the Department prior to issuance of a provisional
				depuration plant certification. The depuration plant operations manual shall be
				updated as changes occur in the depuration plant;
8. The plant capacity shall be filed by the firm
				and approved by the Department utilizing the criteria specified in
				8:13-2.13 prior to provisional
				certification approval by the Department;
9. Each plant must have at least one employee
				designated a certified depuration plant operator. Applicants for DPO shall take a
				standard examination administered by the Department which demonstrates a
				comprehensive knowledge of the principles and procedures of the depuration process
				and the provisions of the rules at N.J.A.C. 8:13-2. Applicants must obtain a passing
				score of at least 70 in order to receive certification;
10. A plant verification study shall be conducted
				by the operator prior to receiving provisional certification. This verification
				study shall demonstrate to the Department that all critical parameters meet the
				specifications as set forth in this chapter and are adequate to insure sufficient
				physiological activity of the shellfish for purification to occur at any point in
				the tank under maximum loading conditions, and plant verification studies must
				include at least three consecutive process runs which meet all critical activities
				as well as the end point bacteriological standards set forth under
				8:13-2.21 for each process
				batch.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 13 - SHELLFISH › Subchapter 2 - DEPURATION OF HARD SHELL AND SOFT SHELL CLAMS › Section 8:13-2.6 - Final certificate requirements

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Considering the
				extremes of environmental conditions and physiological status of bivalves an
				acceptable process verification study shall be conducted during periods when extreme
				conditions are known to occur. Only after this additional process verification study
				is completed indicating that all critical activities have been met, including
				meeting the bacteriological standards set forth under
				8:13-2.21, will final certification be
				considered by the Department.
(b) Final
				certification will be issued based upon a record of satisfactory compliance with the
				HACCP Plan and scheduled depuration process which is incorporated in the Depuration
				Plant Operations Manual and the requirements of (a) above.
(c) The certificate shall expire on June 30 of
				each year. Certificate renewal is required each year on forms supplied by the
				Department.
(d) Shellfish certification
				and food/cosmetic license are not transferable with respect to changes in location
				and/or ownership.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 13 - SHELLFISH › Subchapter 2 - DEPURATION OF HARD SHELL AND SOFT SHELL CLAMS › Section 8:13-2.7 - Certification restrictions, suspensions, and revocations

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Depuration Plant
				(DP) certification is limited to the depuration and sale of depurated
				clams.
(b) The certificate issued by the
				Department pursuant to these rules may be suspended or revoked for any violation of
				Title 24 of the Revised Statutes or of any rule or regulation of the Department or
				when bacteriological data shows that the depuration process is not reducing fecal
				coliform levels to the standards set forth in these rules. Any violation of a
				special permit to possess shellfish harvested from special restricted waters issued
				by the Department of Environmental Protection is grounds for suspension or
				revocation of the certificate issued by the Department.
(c) The Department, when in its judgement has
				determined that any of the critical activities of the depuration rules are violated,
				may, before a hearing, suspend the certification pending the hearing. When the
				certification has been suspended, the person shall have the right to an expedited
				hearing. In all other cases, the person shall be afforded the opportunity for a
				hearing in accordance with the Administrative Procedure Act,
				52:14B-1 et seq. and
				52:14F-1 et seq., and the Uniform
				Administrative Rules of Practice, N.J.A.C. 1:1, prior to the suspension or
				revocation of the license. When the special permit issued by the Department of
				Environmental Protection under N.J.A.C. 7:12-9 is suspended or revoked, the
				shellfish certificate issued by the Department is no longer valid.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 13 - SHELLFISH › Subchapter 2 - DEPURATION OF HARD SHELL AND SOFT SHELL CLAMS › Section 8:13-2.8 - Plant location and site specification

Current through Register Vol. 56, No. 14, July 15, 2024
The depuration plant shall be located in such an area where
				  seawater of proper quality and sufficient quantity is available for the process. The
				  plant shall be located close enough to the harvest site to minimize travel time, to
				  prevent excessive bacterial multiplication, and to reduce stress in the clams. The
				  plant shall be so located that it will not be subject to flooding by high tides.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 13 - SHELLFISH › Subchapter 2 - DEPURATION OF HARD SHELL AND SOFT SHELL CLAMS › Section 8:13-2.9 - Plant design

Current through Register Vol. 56, No. 14, July 15, 2024
The plant shall be designed in such a manner as to prevent
				  cross-contamination of undepurated and depurated clams and in order that a video
				  surveillance system can effectively monitor all critical activities. Washing and
				  culling facilities, with a convenient supply of potable wash water which meets the
				  requirements of N.J.A.C. 7:10 (Safe Drinking Water Act rules), shall be provided for
				  untreated and treated clams. Three separate dry storage areas meeting the
				  requirements of 8:13-2.11 shall be provided for
				  undepurated clams, clams depurated pending laboratory approval, and depurated
				  approved clams. The plant shall be provided with potable running water, electricity,
				  and sewage disposal sufficient to meet all the specifications and carry out all the
				  requirements set forth in these rules.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 13 - SHELLFISH › Subchapter 2 - DEPURATION OF HARD SHELL AND SOFT SHELL CLAMS › Section 8:13-2.10 - Transportation of clams

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The vessel(s) or
				vehicle(s) used in the transportation of clams shall be kept in a clean and sanitary
				condition. The clams stored and transported in the vessel(s) shall be protected from
				undue environmental stress such as freezing in winter and overheating in direct
				sunlight during the summer months. Clams shall be protected from contamination at
				all times during harvesting and transportation to the depuration plant.
(b) A waterproof serially numbered
				harvester-allocation tag approved by the Department shall be issued by the DPO and
				affixed to each harvest container in the plant as part of the daily harvest
				allocation, as specified in
				8:13-2.24. The tags shall be accounted
				for or used that day only.
(c) Only
				serially numbered "U.S. Standard" bushel size containers shall be used in the
				harvesting, transportation, and receiving of hard shell and soft shell clams at the
				depuration plant unless written approval is given to use an alternate standard type
				of container. All reasonable measures shall be taken to assure that containers of
				clams received at the plant are filled to a level not to exceed one U.S. standard
				bushel.
(d) During the unloading
				procedures from the harvesting vessels at the designated times and locations, the
				containers of clams shall not be covered and shall be open to view.
(e) Once off-loading commences, the containers of
				shellfish shall immediately be moved into the plant and the attached harvester
				allocation tag shall be date and time stamped upon receipt by the DPO on that
				harvest day.
(f) Overland transportation
				must be approved by the SRRSC under the provisions of DEP rules N.J.A.C.
				7:12-9.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 13 - SHELLFISH › Subchapter 2 - DEPURATION OF HARD SHELL AND SOFT SHELL CLAMS › Section 8:13-2.11 - Shellfish storage

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Shellfish received
				from harvesters shall be stored immediately in the undepurated temperature
				controlled storage unit prior to depuration unless the shellfish are already
				temperature acclimated as required below and will be depurated upon receipt from the
				harvesters.
1. This unit shall be cool and protect
				the shellfish from contamination.
2.
				When staging the shellfish for depuration, the internal temperature of the shellfish
				in the controlled storage unit shall be maintained within five degrees Fahrenheit
				(2.78 degrees Celsius) of the process water temperature, but shall not exceed 68
				degrees Fahrenheit (20 degrees Celsius).
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 13 - SHELLFISH › Subchapter 2 - DEPURATION OF HARD SHELL AND SOFT SHELL CLAMS › Section 8:13-2.12 - Seawater quality

Current through Register Vol. 56, No. 14, July 15, 2024
(a) No seawater shall be
				used for depuration unless it meets the following requirements:
1. The source seawater meets or is better than the
				criteria for Special Restricted Waters as specified in the Model Ordinance then in
				effect.
2. The source seawater shall be
				free of toxic chemicals, pesticides, detergents, dye stuffs, radioisotopes and
				marine toxins in concentrations which exceed established State/Federal rules or
				regulations, or exist in concentrations deemed hazardous by State or Federal
				officials.
3. Salinity must be within 20
				percent of the harvest area value, at the time of harvest.