A837

An Act concerning safe handling of hazardous drugs and supplementing Title 34 of the Revised Statutes.

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. This act shall be known and may be cited as the “Hazardous Drug Safe Handling Act.”

2. a. The Legislature finds and declares that:

(1) Health care personnel who work with or near hazardous drugs in health care settings may be exposed to these agents in the air and through contact with work surfaces, clothing, medical equipment, and patients;

(2) According to the National Institute for Occupational Safety and Health (NIOSH), which is part of the Centers for Disease Control and Prevention, early concerns about occupational exposure to anticancer drugs first appeared in the 1970s;

(3) Antineoplastic and other hazardous drugs have been identified with a number of acute, short-term, and chronic effects, including skin rashes, infertility, miscarriage, birth defects, liver and kidney damage, damage to the bone marrow, damage to the heart and lungs, and various cancers; and

(4) In 2004, NIOSH published an alert on preventing occupational exposures to antineoplastic drugs in health care settings. NIOSH urges that all hazardous drugs be universally handled according to standard precautions as outlined in the alert, which includes recommended procedures for assessing workplace hazards, handling hazardous drugs, and using and maintaining equipment, as well as a list of “drugs considered hazardous,” which was updated in 2010, 2012, and 2014.

b. The Legislature therefore determines that it is the public policy of the State to provide for the appropriate regulation of the handling of hazardous drugs consistent with the NIOSH alert, regardless of the setting in which health care is provided, in order to protect health care personnel from potentially harmful exposure to antineoplasic and other hazardous drugs.

3. As used in this act:

“Animal or veterinary facility” means an animal or veterinary facility as defined in section 1 of P.L.1983, c.98 (C.45:16-1.1).

“Antineoplastic” means inhibiting or preventing the growth and spread of tumors or malignant cells.

“Commissioner” means the Commissioner of Labor and Workforce Development.

“Hazardous drugs” means drugs that exhibit one or more of the following characteristics in humans or animals: carcinogenicity; teratogenicity or other developmental toxicity; reproductive toxicity; organ toxicity at low doses; genotoxicity; or structure and toxicity profiles that mimic existing hazardous drugs. This term includes, but is not limited to, antineoplastic drugs.

“Health care personnel” means any individual in a health care setting or veterinary facility who works with or near, handles, comes in contact with, or otherwise touches a hazardous drug.

“Health care setting” means any facility or institution, whether public or private, engaged in medical services, including diagnosis or treatment of human disease, pain, injury, deformity or physical condition, including, but not limited to, a health care facility licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.), a pharmacy, and a boarding home for the sheltered care of adult persons, but excluding institutions that provide healing solely by prayer.

“NIOSH” means the National Institute for Occupational Safety and Health in the Centers for Disease Control and Prevention.

“Stakeholder group” means a group of stakeholders in the areas of health care and workplace safety, which shall consist of: a representative of the Cancer Institute of New Jersey; a representative of the New Jersey Hospital Association; practicing physicians from impacted specialties including, but not limited to, oncology; pharmacists; registered nurses, including one representative from the New Jersey Chapters of the Oncology Nursing Society; three representatives from organized labor unions representing health care personnel, two of whom shall serve at the recommendation of the New Jersey State AFL-CIO; and other interested stakeholders.

4. a. No later than 12 months after the effective date of this act, the commissioner, in consultation with the Commissioner of Health, the Director of the Division of Consumer Affairs in the Department of Law and Public Safety, and a stakeholder group as defined in section 3 of P.L. , c. (C. ) (pending before the Legislature as this bill), shall adopt consensus-driven standards and regulations in accordance with the “Administrative Procedure Act,” P.L.1968, c.410 (C.52:14B-1 et seq.) concerning the handling of hazardous drugs by health care personnel in a health care setting or animal or veterinary facility.

b. The standards and regulations to be adopted pursuant to subsection a. of this section shall describe the hazardous drugs for which handling is to be regulated, the methods and procedures for handling such drugs, an implementation plan, and such other requirements as may be necessary to protect the health and safety of health care personnel, including, but not limited to:

(1) written, site-specific hazardous drug control programs to avoid occupational exposure to hazardous drugs through transporting, compounding, administering, disposing, or other handling of the drugs;

(2) hazard assessments to determine precautions necessary to protect health care personnel from exposure to hazardous drugs;

(3) engineering controls to eliminate or minimize exposure to hazardous drugs;

(4) personal protective equipment and the circumstances under which personal protective equipment shall be used by health care personnel;

(5) safe handling practices related to hazardous drugs, including handling, receiving, storage, preparing, administering, waste handling, cleaning, housekeeping, labeling and signage, and maintenance practices;

(6) spill control and response procedures;

(7) training standards and training programs;

(8) requirements for recordkeeping, including records related to training sessions, qualifications, incident reports, and other pertinent information; and

(9) medical surveillance, which shall include provisions requiring, at a minimum, a medical evaluation for health care personnel who directly handle hazardous drugs, at no cost to the personnel, at the time of hiring, upon exposure to hazardous drugs, and upon request when such request is related to reproductive concerns.

c. The standards and regulations adopted pursuant to subsection a. of this section shall include a schedule of penalties for violations of the provisions of this act or its rules and regulations, which schedule may incorporate such factors as the commissioner determines are relevant to assessing penalties for violations, including any history of previous violations, the seriousness of the current violation, and any other factors which the commissioner may establish by regulation.

d. The standards and regulations adopted pursuant to subsection a. of this section, to the extent feasible, shall be consistent with and not exceed recommendations in the NIOSH 2004 alert entitled “Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings.” The standards and regulations may incorporate applicable updates and changes to NIOSH guidelines, and shall be reviewed by the commissioner, in consultation with a stakeholder group as defined in section 3 of P.L. , c. (C. ) (pending before the Legislature as this bill), every two years.

5. Employers of health care personnel shall provide hazardous drugs training to all employees who have or are likely to have occupational exposure to hazardous drugs. This training shall take place at the time of the employee’s initial job assignment and on an annual basis thereafter. Such training shall be consistent with the standards and regulations adopted pursuant to subsection a. of section 4 of P.L. , c. (C. ) (pending before the Legislature as this bill).

6. a. This act, and its standards and regulations, shall be enforced by the commissioner, who has right-of-entry to all pertinent premises and records for the purposes of inspection and information.

b. The commissioner is authorized to assess and collect administrative penalties for violations of the provisions of this act or its rules and regulations, consistent with the schedule of penalties adopted pursuant to section 4 of P.L. , c. (C. ) (pending before the Legislature as this bill).

c. No administrative penalty shall be levied pursuant to this section unless the commissioner provides the alleged violator with notification by certified mail of the violation and of the amount of the penalty, and an opportunity to request a hearing before the commissioner, or the commissioner’s designee, within 15 days following receipt of the notice. If a hearing is requested, the commissioner shall issue a final order upon such hearing and a finding that a violation has occurred. If no hearing is requested, the notice shall become a final order upon expiration of the 15-day period. Payment of the penalty is due when a final order is issued or when the notice becomes a final order.

d. Any penalty imposed pursuant to this section may be recovered with costs in a summary proceeding commenced by the commissioner pursuant to the “Penalty Enforcement Law of 1999,” P.L.1999, c.274 (C.2A:58-10 et seq.).

7. This act shall take effect immediately.

STATEMENT

This bill establishes the “Hazardous Drug Safe Handling Act,” which would require the Commissioner of Labor and Workforce Development (“commissioner”) to promulgate rules and regulations concerning the handling of hazardous drugs by health care personnel. Hazardous drugs, including antineoplastic drugs used in chemotherapy, have been associated with a number of adverse acute, short-term, and chronic effects, including skin rashes, infertility, miscarriage, birth defects, various cancers, and damage to the liver, kidneys, bone marrow, heart, and lungs.

Under the bill, no later than 12 months after the effective date, the commissioner, in consultation with the Commissioner of Health, the Director of the Division of Consumer Affairs in the Department of Law and Public Safety, and a stakeholder group comprised of certain members as set forth in the bill, will be required to adopt consensus-driven standards and regulations concerning the handling of hazardous drugs by health care personnel in a health care setting or an animal or veterinary facility. The standards and regulations will describe the hazardous drugs for which handling is to be regulated, the methods and procedures for handling such drugs, an implementation plan, and such other requirements as may be necessary to protect the health and safety of health care personnel.

The standards and regulations may include, but are not limited to: (1) written, site-specific hazardous drug control programs to avoid occupational exposure through transporting, compounding, administering, disposing, or other handling of hazardous drugs; (2) hazard assessments to determine precautions necessary to protect health care personnel from exposure; (3) engineering controls to eliminate or minimize exposure; (4) personal protective equipment and the circumstances under which personal protective equipment must be used by health care personnel; (5) safe handling practices, including handling, receiving, storage, preparing, administering, waste handling, cleaning, housekeeping, labeling and signage, and maintenance practices; (6) spill control and response procedures; (7) training standards and practices; (8) requirements for recordkeeping, including records related to training sessions, qualifications, incident reports, and other pertinent information; and (9) medical surveillance, including, at a minimum, a medical evaluation for health care personnel who directly handle hazardous drugs, at no cost to the personnel, at the time of hiring, upon exposure to hazardous drugs, and upon request when such request is related to reproductive concerns.

These standards and regulations would also include a schedule of penalties for violations, which may incorporate such factors as the commissioner determines relevant to assessing penalties for violations, including any history of previous violations, the seriousness of the current violation, and any other factors which the commissioner may establish by regulation.

In addition, the standards and regulations would, to the extent feasible, be consistent with and not exceed recommendations in the 2004 alert by the National Institute for Occupational Safety and Health (NIOSH) in the Centers for Disease Control and Prevention, entitled “Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings.” The standards and regulations may incorporate applicable updates and changes to NIOSH guidelines, and the bill would require the standards and regulations be reviewed by the commissioner, in consultation with a stakeholder group, every two years.

Employers of health care personnel will be required to provide hazardous drugs training to all employees who have or are likely to have occupational exposure to hazardous drugs. The training will take place at the time of the employee’s initial job assignment, and on an annual basis thereafter.

The commissioner will enforce the provisions of the bill, and will have right-of-entry to all pertinent premises and records for the purposes of inspection and information. The commissioner will be authorized to assess and collect administrative penalties for violations of the bill consistent with the schedule of penalties set forth in regulation. The bill would prohibit levying an administrative penalty unless the commissioner provides the alleged violator with notification, by certified mail, of the violation and of the amount of the penalty, and an opportunity to request a hearing before the commissioner, or the commissioner’s designee, within 15 days following receipt of the notice. If a hearing is requested, the commissioner would issue a final order upon such hearing and a finding that a violation has occurred. If no hearing is requested, the notice would become a final order upon expiration of the 15-day period. Payment of the penalty would be due when a final order is issued or when the notice becomes a final order.