Rule Proposal

VOLUME 49, ISSUE 2
ISSUE DATE: JANUARY 17, 2017
RULE PROPOSALS
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
CONTROLLED DANGEROUS SUBSTANCES


   

Proposed Amendment: N.J.A.C. 13:45H-10.1

Schedules of Controlled Dangerous Substances
 
Authorized By: Steve C. Lee, Director, Division of Consumer Affairs.
 
Authority: N.J.S.A. 24:21-3(a) and 24:21-5(a).
 
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
 
Proposal Number: PRN 2017-009.
 
Submit comments by March 18, 2017, to:
 
   Steve C. Lee, Director
   Division of Consumer Affairs
   124 Halsey Street
   PO Box 45027
   Newark, New Jersey 07101
   or electronically at DCAProposal@dca.lps.state.nj.us
 
The agency proposal follows:
 
Summary

The Director of the Division of Consumer Affairs, pursuant to his authority under N.J.S.A. 24:21-31(b)(3)(a) of the New Jersey Controlled Dangerous Substances Act (the Act), is proposing to amend the controlled dangerous substances schedules set forth in N.J.A.C. 13:45H-10.1 to permanently place the following seven substances in the list of Schedule I substances in New Jersey: Furanyl Fentanyl, with a chemical composition of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] -2-furancarboxamide, monohydrochloride or N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide; 3-Methylfentanyl, with a chemical composition of 3-methyl-N-phenyl-N-[1-(2-phenethyl-4-piperidyl)-propanamide); 3-Methyl Butyrylfentanyl, with a chemical composition of 3-Methyl, N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]-butanamide, monohydrochloride; Valeryl Fentanyl, with a chemical composition of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]-pentanamide, monohydrochloride; Norfentanyl, with a chemical composition of N-phenyl-N-4-piperidinyl-propanamide; Para-Fluorobutyryl-Fentanyl, with a chemical composition of N-(4-fluorophenyl)-N-[1-(2-phenylethyl)-4-piperidinyl]-butanamide, monohydrochloride; and Carfentanyl, with a chemical composition of 2-hydroxypropane-1, 2, 3-tricarboxylic acid; methyl 1-(2-phenylethyl)-4-(N-propanoylanilino) piperidine-4-carboxylateor.

On September 27, 2016, the Director, pursuant to his authority under the Act, issued an order to temporarily place these seven illicit fentanyls in Schedule I. Legitimately produced fentanyl is a Schedule II substance under Federal and New Jersey law, and is considered the most potent opioid available for use in medical treatment, being 50 to 100 times more potent than morphine. It is approved for use in managing acute or chronic pain most often associated with advanced cancer and as an anesthetic agent in surgery, and can be lethal in very small doses. Illicit fentanyl products are produced by drug trafficking networks in clandestine laboratories and are sold on illicit drug markets, and have been linked to increases in reported drug deaths and non-fatal overdoes throughout the United States, including in New Jersey.

Illicit fentanyls pose a significant danger to persons who abuse these substances, and overdoses may lead to seizures, severe drowsiness, low blood pressure, slowed heartbeat, and respiratory depression. In addition, these substances pose a significant danger to public health workers, first responders, and law enforcement personnel who come into contact with these substances through the skin or by accidental inhalation of airborne powder. These substances have no known medical use in the United [page=180] States and are not used to produce or manufacture any legitimate product sold in the United States.

Placing these seven substances in Schedule I makes the possession, sale, and distribution of such substances unlawful. Specifically, under N.J.S.A. 2C:35-5, a person who manufactures, distributes, dispenses, or possesses with the intent to manufacture, distribute, or dispense, a Schedule I substance is guilty of a third degree crime, punishable by three to five years in prison, and a penalty of up to $ 25,000. Under N.J.S.A. 2C:35-10, possession of a Schedule I substance is a crime of the third degree, punishable by three to five years in prison and a penalty of up to $ 35,000.

The Director's temporary scheduling order is set to expire on June 23, 2017. Consistent with the requirements of N.J.S.A. 24:21-31(b)(3)(a), the Director held a public hearing on December 20, 2016 to take testimony from interested parties concerning his intention to permanently place the seven illicit fentanyls in Schedule I. A notice concerning the issuance of the temporary order, including the full text of the order, and announcing the public hearing, appeared in the New Jersey Register on December 5, 2016 at 48 N.J.R. 2638(b). No members of the public presented testimony at the public hearing in opposition to the proposed amendment.

In light of the high potential for abuse associated with the seven substances, and because these substances have no accepted medical use in treatment in the United States, the Director believes the permanent placement of these substances in Schedule I is appropriate under N.J.S.A. 24:21-5(a), and is necessary to combat the danger to the health, safety, and welfare of the people of the State of New Jersey posed by the use, sale, and distribution of illicit fentanyl products.

The Division has provided a 60-day comment period for this notice of proposal. Therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.
 
Social Impact

The Division believes that the proposed amendment will have a positive impact upon the citizens of New Jersey. Placing illicit fentanyls in Schedule I under the State Controlled Dangerous Substances Act will subject these substances to the strictest level of State oversight and control, helping to decrease their availability, thereby helping to safeguard the public health, safety, and welfare of New Jersey citizens.
 
Economic Impact

The proposed amendment may have an economic impact on businesses that, prior to the execution of the Division's temporary scheduling order, sold substances now included in Schedule I under the State Controlled Dangerous Substance Act. The proposed amendment will preclude such businesses from selling these substances on a permanent basis. These substances have no known medical use in the United States and are not used to produce or manufacture any legitimate product sold in the United States.
 
Federal Standards Statement

A Federal standards analysis is not required because the proposed amendment is governed by the New Jersey Controlled Dangerous Substances Act, N.J.S.A. 24:21-1 et seq., specifically N.J.S.A. 24:21-3(a) and 24:21-5(a). Although New Jersey has adopted, in N.J.A.C. 13:45H-10.1(a), the Federal controlled dangerous substances Schedules I through V codified at 21 CFR 1308.11 through 1308.15, as amended and supplemented, the Director is authorized under N.J.S.A. 24:21-3 to add, delete, or reschedule substances under the New Jersey Controlled Dangerous Substances Act.
 
Jobs Impact

The Division does not believe that the proposed amendment will result in the creation or the loss of jobs in the State.
 
Agriculture Industry Impact

The Division does not believe that the proposed amendment will have any impact on the agriculture industry of the State.
 
Regulatory Flexibility Analysis

If New Jersey businesses that sell the seven fentanyl substances proposed for permanent inclusion in Schedule I are considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies.

The proposed amendment will impose compliance requirements upon such businesses to the extent that placing these substances on the list of Schedule I substances under the New Jersey Controlled Dangerous Substances Act will make it unlawful, on a permanent basis, for businesses to sell or distribute these substances.

No additional professional services will be needed to comply with the proposed amendment. The costs of compliance with the proposed amendment are discussed in the Economic Impact above. The Division believes that the proposed amendment should be uniformly applied to all businesses in the State in order to ensure the health, safety, and welfare of the general public. Therefore, no differing compliance requirements for any businesses are provided based upon the size of the business.
 
Housing Affordability Impact Analysis

The proposed amendment will have an insignificant impact on the affordability of housing in New Jersey and there is an extreme unlikelihood that the amendment would evoke a change in the average costs associated with housing because the proposed amendment concerns the scheduling of illicit fentanyls as Schedule I controlled dangerous substances under the New Jersey Controlled Dangerous Substances Act.
 
Smart Growth Development Impact Analysis

The proposed amendment will have an insignificant impact on smart growth and there is an extreme unlikelihood that the amendment would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the proposed amendment concerns the scheduling of illicit fentanyls as Schedule I controlled dangerous substances under the New Jersey Controlled Dangerous Substances Act.
 
Full text of the proposal follows (additions indicated in boldface thus):
 
13:45H-10.1    Schedules of controlled dangerous substances
 
(a)-(d) (No change.)
 
(e) In accordance with (d) above, the following substances shall be designated and controlled as Schedule I controlled dangerous substances:
 
1.-9. (No change.)
 
10. Illicit fentanyls. Illicit fentanyls include any material, compound, mixture, or preparation that is not listed as a controlled substance in Schedules I through V, is not a Federal Food and Drug Administration (FDA) approved drug, and contains any quantity of the following substances, their salts, isomers (whether optical, positional, or geometric), homologues (analogs), and salts of isomers, and homologues (analogs) unless specifically excepted whenever the existence of these salts, isomers, homologues (analogs), and salts of isomers and homologues (analogs) is possible within the specific chemical designations:
 
i. Furanyl Fentanyl, with a chemical composition of N-phenyl-N- [1-(2-phenylethyl)-4-piperidinyl]-2-furancarboxamide, monohydrochloride or N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide;
 
ii. 3-Methylfentanyl, with a chemical composition of 3-methyl-N-phenyl-N-[1-(2-phenethyl-4-piperidyl)-propanamide);
 
iii. 3-Methyl Butyrylfentanyl, with a chemical composition of 3-Methyl, N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]-butanamide, monohydrochloride;
 
iv. Valeryl Fentanyl, with a chemical composition of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]-pentanamide, monohydrochloride;
 
v. Norfentanyl, with a chemical composition of N-phenyl-N-4-piperidinyl-propanamide;
 
vi. Para-Fluorobutyryl-Fentanyl, with a chemical composition of N-(4-fluorophenyl)-N-[1-(2-phenylethyl)-4-piperidinyl]-butanamide, monohydrochloride; and
 
vii. Carfentanyl, with a chemical composition of 2-hydroxypropane-1, 2, 3-tricarboxylic acid; methyl 1-(2-phenylethyl)-4-(N-propanoylanilino) piperidine-4-carboxylateor.