2016 -- S 2609

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LC004776

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2016

____________

A N   A C T

RELATING TO INSURANCE -- ACCIDENT AND SICKNESS INSURANCE POLICIES

     Introduced By: Senators DiPalma, and Archambault

     Date Introduced: February 25, 2016

     Referred To: Senate Health & Human Services

     It is enacted by the General Assembly as follows:

     SECTION 1. Chapter 27-18 of the General Laws entitled "Accident and Sickness

Insurance Policies" is hereby amended by adding thereto the following section:

     27-18-82. Cancer patient safety and environmental protection. -- (a) Purpose. It is the

policy of the state of Rhode Island not to permit introduction of pollutants into the ground waters

and water systems of the state or otherwise to be discharged in concentrations which are known to

be toxic, carcinogenic, mutagenic, or teratogenic as the same are defined in the Rhode Island

department of environmental management groundwater quality rules and the rules and regulations

for hazardous waste management. More specifically, the Rhode Island department of

environmental management, in regulation #OEM OWM-HW 01-14, most recent revision dated

January 7, 2014, defines certain antineoplastic or cytotoxic chemotherapy agents and drugs as

"extremely hazardous waste."

     (b) Findings. (1) It is acknowledged by medical experts that bodily wastes of patients

undergoing chemotherapy treatment may contain levels of chemicals that are toxic, carcinogenic,

mutagenic or teratogenic for a certain period of time, to such an extent that the World Health

Organization defines genotoxic waste as chemotherapy drug waste including urine, feces and

vomit from patients, which may contain potentially hazardous amounts of the administered

cytostatic drugs or of their metabolites, and which should be considered genotoxic for at least

forty-eight (48) hours and sometimes up to one week after drug administration. According to the

World Health Organization, ten percent (10%) of known carcinogens are chemicals used to cure

cancer.

     (2) While, according to the American Society of Clinical Oncology, the cost of one

additional cancer patient resulting from the exposure to these harmful chemicals is approximately

one hundred seventy thousand dollars ($170,000) per treatment year, the cost of the

implementation of cytotoxic chemical safety protocols is estimated to be less than two percent

(2%) of that cost.

     (3) The World Health Organization further states that any discharge of genotoxic waste

into the environment could have disastrous ecological consequences. The World Health

Organization places the responsibility for genotoxic waste on the chief pharmacist and further

states that the chief pharmacist also has the special responsibility of ensuring that genotoxic

products are used safely, and that genotoxic waste is managed safely.

     (4) The European Commission, Executive Agency for Health and Consumers undertook a

comprehensive "Study on the Environmental Risks of Medicinal Products" which was released in

June of 2014, drafted by 810 Intelligence Service, a division of Deloitte Consulting LLP,

reviewing the prevalence of contaminants in drinking water and noting the extreme dangers

arising from improper disposal of cytotoxic chemotherapy drugs.

     (5) Dr. Christian G. Daughton, former chief of environmental chemistry for the United

States Environmental Protection Agency, notes in a paper entitled "Eco-directed Sustainable

Prescribing: Feasibility for Reducing Water Contamination by Drugs" published in the journal

"Science of the Total Environment" on June 3, 2014, that generally, the best practice for lowering

the level of drugs in our environment is reduction of dosages, but that "[c]ertain drug classes

(especially cytotoxic chemotherapeutics) may not be amenable to this approach; the best control

measure for such highly toxic drugs may simply be the prevention of urine and feces from

entering sewers."

     (6) The federal Occupational Safety and Health Administration ("OSHA") is the main

federal agency charged with the enforcement of safety and health legislation. OSHA, in concert

with the National Institute for Occupational Safety and Health ("NIOSH") and the Joint

Commission on Healthcare, an independent, not-for-profit organization that accredits and certifies

more than twenty thousand (20,000) health care organizations and programs in the United States,

stated in a 2011 letter to every hospital in the country that "[e]very day in healthcare settings

across America, workers are exposed to hundreds of powerful drugs used for cancer

chemotherapy, antiviral treatments, hormone regimens and other therapies. While these drugs are

used to relieve and heal patients, many of them present serious hazards to the health and safety of

your workers. Some of these drugs have been known to cause cancer, reproductive and

LC004776 - Page 2 of 25

developmental problems, allergic reactions, and other adverse effects that can be irreversible even

after low-level exposures."

     (7) Further, because of the risk of ongoing exposure to these extremely hazardous

excreted drugs, the American Cancer Society has published a comprehensive list of safety

precautions regarding the in-home personal hygiene for individuals undergoing chemotherapy

and their families.

     (8) Therefore, for the protection of both the public health and the environment, the

general assembly shall require that standards are set forth pursuant to this section to address this

serious health and safety issue.

     (c) Chemotherapy precautions following treatment. All physicians, pharmacists, or other

health care professionals licensed in the state of Rhode Island authorized to prescribe and/or

administer chemotherapy treatment shall:

     (1) Provide written notice from the prescribing pharmacist to each patient undergoing

such treatment as to the hazards posed to patients and their families of extremely hazardous

excretions, including, but not limited to, urine, vomit, and feces, for a period following treatment

as generally determined by the food and drug administration label accompanying said

chemotherapy drug or drugs. To the extent such notices are generally consistent with those now

provided for patients undergoing treatment with radioactive drugs, or consistent with the

recommendations of the World Health Organization with regard to cytotoxic drugs, or otherwise

consistent with similar standards that may be approved by the department of environmental

management in the context of a product stewardship plan adopted under chapter 19.16 of title 23,

then the prescribing pharmacist will not be held liable for the form of such notice;

     (2) Participate in an approved product stewardship program for the collection safe and

proper and disposal of Extremely Hazardous Wastes, including Cytotoxic Drugs and related

byproducts and wastes adopted pursuant to chapter 19.16 of title 23 so that providers and patients

can safely collect and contain extremely hazardous excretions for a period of time as determined

by the United States Food and Drug Administration ("FDA") and referenced on the relevant FDA

prescription insert(s).

     (d) Cytotoxic drug producers shall provide for the costs of managing and safely disposing

of the health care waste identified in this section in accordance with chapter 19.16 of title 23.

     (e) Receipt of notice from the party administering chemotherapy drugs or their agent

responsible for proper disposal of the hazardous wastes by the prescribing pharmacist or chief

pharmacist that the wastes have been disposed of in accordance with a product stewardship plan

shall satisfy the responsibility of the prescribing pharmacist hereunder.

LC004776 - Page 3 of 25

     (f) For the purposes of this section, extremely hazardous excretions shall mean any

excretion from a patient on a regimen of chemotherapy agents that are antineoplastic or cytotoxic,

and which may be excreted during the period of administration or the time period referenced in

subsection (c)(2) of this section, including but not limited to, drugs listed in the NIOSH list of

Antineoplastic and Other Hazardous Drugs, as the same may be updated or amended from time to

time.

     SECTION 2. Chapter 27-18.5 of the General Laws entitled "Individual Health Insurance

Coverage" is hereby amended by adding thereto the following section:

     27-18.5-11. Cancer patient safety and environmental protection. -- (a) Purpose. It is

the policy of the state of Rhode Island not to permit introduction of pollutants into the ground

waters and water systems of the state or otherwise to be discharged in concentrations which are

known to be toxic, carcinogenic, mutagenic, or teratogenic as the same are defined in the Rhode

Island department of environmental management groundwater quality rules and the rules and

regulations for hazardous waste management. More specifically, the Rhode Island department of

environmental management, in regulation #OEM OWM-HW 01-14, most recent revision dated

January 7, 2014, defines certain antineoplastic or cytotoxic chemotherapy agents and drugs as

"extremely hazardous waste."

     (b) Findings. (1) It is acknowledged by medical experts that bodily wastes of patients

undergoing chemotherapy treatment may contain levels of chemicals that are toxic, carcinogenic,

mutagenic or teratogenic for a certain period of time, to such an extent that the World Health

Organization defines genotoxic waste as chemotherapy drug waste including urine, feces and

vomit from patients, which may contain potentially hazardous amounts of the administered

cytostatic drugs or of their metabolites, and which should be considered genotoxic for at least

forty-eight (48) hours and sometimes up to one week after drug administration. According to the

World Health Organization, ten percent (10%) of known carcinogens are chemicals used to cure

cancer.

     (2) While, according to the American Society of Clinical Oncology, the cost of one

additional cancer patient resulting from the exposure to these harmful chemicals is approximately

one hundred seventy thousand dollars ($170,000) per treatment year, the cost of the

implementation of cytotoxic chemical safety protocols is estimated to be less than two percent

(2%) of that cost.

     (3) The World Health Organization further states that any discharge of genotoxic waste

into the environment could have disastrous ecological consequences. The World Health

Organization places the responsibility for genotoxic waste on the chief pharmacist and further

LC004776 - Page 4 of 25

states that the chief pharmacist also has the special responsibility of ensuring that genotoxic

products are used safely, and that genotoxic waste is managed safely.

     (4) The European Commission, Executive Agency for Health and Consumers undertook a

comprehensive "Study on the Environmental Risks of Medicinal Products" which was released in

June of 2014, drafted by 810 Intelligence Service, a division of Deloitte Consulting LLP,

reviewing the prevalence of contaminants in drinking water and noting the extreme dangers

arising from improper disposal of cytotoxic chemotherapy drugs.

     (5) Dr. Christian G. Daughton, former chief of environmental chemistry for the United

States Environmental Protection Agency, notes in a paper entitled "Eco-directed Sustainable

Prescribing: Feasibility for Reducing Water Contamination by Drugs" published in the journal

"Science of the Total Environment" on June 3, 2014, that generally, the best practice for lowering

the level of drugs in our environment is reduction of dosages, but that "[c]ertain drug classes

(especially cytotoxic chemotherapeutics) may not be amenable to this approach; the best control

measure for such highly toxic drugs may simply be the prevention of urine and feces from

entering sewers."

     (6) The federal Occupational Safety and Health Administration ("OSHA") is the main

federal agency charged with the enforcement of safety and health legislation. OSHA, in concert

with the National Institute for Occupational Safety and Health ("NIOSH") and the Joint

Commission on Healthcare, an independent, not-for-profit organization that accredits and certifies

more than twenty thousand (20,000) health care organizations and programs in the United States,

stated in a 2011 letter to every hospital in the country that "[e]very day in healthcare settings

across America, workers are exposed to hundreds of powerful drugs used for cancer

chemotherapy, antiviral treatments, hormone regimens and other therapies. While these drugs are

used to relieve and heal patients, many of them present serious hazards to the health and safety of

your workers. Some of these drugs have been known to cause cancer, reproductive and

developmental problems, allergic reactions, and other adverse effects that can be irreversible even

after low-level exposures."

     (7) Further, because of the risk of ongoing exposure to these extremely hazardous

excreted drugs, the American Cancer Society has published a comprehensive list of safety

precautions regarding the in-home personal hygiene for individuals undergoing chemotherapy

and their families.

     (8) Therefore, for the protection of both the public health and the environment, the

general assembly shall require that standards are set forth pursuant to this section to address this

serious health and safety issue.

LC004776 - Page 5 of 25

     (c) Chemotherapy precautions following treatment. All physicians, pharmacists, or other

health care professionals licensed in the state of Rhode Island authorized to prescribe and/or

administer chemotherapy treatment shall:

     (1) Provide written notice from the prescribing pharmacist to each patient undergoing

such treatment as to the hazards posed to patients and their families of extremely hazardous

excretions, including, but not limited to, urine, vomit, and feces, for a period following treatment

as generally determined by the food and drug administration label accompanying said

chemotherapy drug or drugs. To the extent such notices are generally consistent with those now

provided for patients undergoing treatment with radioactive drugs, or consistent with the

recommendations of the World Health Organization with regard to cytotoxic drugs, or otherwise

consistent with similar standards that may be approved by the department of environmental

management in the context of a product stewardship plan adopted under chapter 19.16 of title 23,

then the prescribing pharmacist will not be held liable for the form of such notice;

     (2) Participate in an approved product stewardship program for the collection safe and

proper and disposal of Extremely Hazardous Wastes, including Cytotoxic Drugs and related

byproducts and wastes adopted pursuant to chapter 19.16 of title 23 so that providers and patients

can safely collect and contain extremely hazardous excretions for a period of time as determined

by the United States Food and Drug Administration ("FDA") and referenced on the relevant FDA

prescription insert(s).

     (d) Cytotoxic drug producers shall provide for the costs of managing and safely disposing

of the health care waste identified in this section in accordance with chapter 19.16 of title 23.

     (e) Receipt of notice from the party administering chemotherapy drugs or their agent

responsible for proper disposal of the hazardous wastes by the prescribing pharmacist or chief

pharmacist that the wastes have been disposed of in accordance with a product stewardship plan

shall satisfy the responsibility of the prescribing pharmacist hereunder.

     (f) For the purposes of this section, extremely hazardous excretions shall mean any

excretion from a patient on a regimen of chemotherapy agents that are antineoplastic or cytotoxic,

and which may be excreted during the period of administration or the time period referenced in

subsection (c)(2) of this section, including but not limited to, drugs listed in the NIOSH list of

Antineoplastic and Other Hazardous Drugs, as the same may be updated or amended from time to

time.

     SECTION 3. Chapter 27-19 of the General Laws entitled "Nonprofit Hospital Service

Corporations" is hereby amended by adding thereto the following section:

     27-19-73. Cancer patient safety and environmental protection. -- (a) Purpose. It is the

LC004776 - Page 6 of 25

policy of the state of Rhode Island not to permit introduction of pollutants into the ground waters

and water systems of the state or otherwise to be discharged in concentrations which are known to

be toxic, carcinogenic, mutagenic, or teratogenic as the same are defined in the Rhode Island

department of environmental management groundwater quality rules and the rules and regulations

for hazardous waste management. More specifically, the Rhode Island department of

environmental management, in regulation #OEM OWM-HW 01-14, most recent revision dated

January 7, 2014, defines certain antineoplastic or cytotoxic chemotherapy agents and drugs as

"extremely hazardous waste."

     (b) Findings. (1) It is acknowledged by medical experts that bodily wastes of patients

undergoing chemotherapy treatment may contain levels of chemicals that are toxic, carcinogenic,

mutagenic or teratogenic for a certain period of time, to such an extent that the World Health

Organization defines genotoxic waste as chemotherapy drug waste including urine, feces and

vomit from patients, which may contain potentially hazardous amounts of the administered

cytostatic drugs or of their metabolites, and which should be considered genotoxic for at least

forty-eight (48) hours and sometimes up to one week after drug administration. According to the

World Health Organization, ten percent (10%) of known carcinogens are chemicals used to cure

cancer.

     (2) While, according to the American Society of Clinical Oncology, the cost of one

additional cancer patient resulting from the exposure to these harmful chemicals is approximately

one hundred seventy thousand dollars ($170,000) per treatment year, the cost of the

implementation of cytotoxic chemical safety protocols is estimated to be less than two percent

(2%) of that cost.

     (3) The World Health Organization further states that any discharge of genotoxic waste

into the environment could have disastrous ecological consequences. The World Health

Organization places the responsibility for genotoxic waste on the chief pharmacist and further

states that the chief pharmacist also has the special responsibility of ensuring that genotoxic

products are used safely, and that genotoxic waste is managed safely.

     (4) The European Commission, Executive Agency for Health and Consumers undertook a

comprehensive "Study on the Environmental Risks of Medicinal Products" which was released in

June of 2014, drafted by 810 Intelligence Service, a division of Deloitte Consulting LLP,

reviewing the prevalence of contaminants in drinking water and noting the extreme dangers

arising from improper disposal of cytotoxic chemotherapy drugs.

     (5) Dr. Christian G. Daughton, former chief of environmental chemistry for the United

States Environmental Protection Agency, notes in a paper entitled "Eco-directed Sustainable

LC004776 - Page 7 of 25

Prescribing: Feasibility for Reducing Water Contamination by Drugs" published in the journal

"Science of the Total Environment" on June 3, 2014, that generally, the best practice for lowering

the level of drugs in our environment is reduction of dosages, but that "[c]ertain drug classes

(especially cytotoxic chemotherapeutics) may not be amenable to this approach; the best control

measure for such highly toxic drugs may simply be the prevention of urine and feces from

entering sewers."

     (6) The federal Occupational Safety and Health Administration ("OSHA") is the main

federal agency charged with the enforcement of safety and health legislation. OSHA, in concert

with the National Institute for Occupational Safety and Health ("NIOSH") and the Joint

Commission on Healthcare, an independent, not-for-profit organization that accredits and certifies

more than twenty thousand (20,000) health care organizations and programs in the United States,

stated in a 2011 letter to every hospital in the country that "[e]very day in healthcare settings

across America, workers are exposed to hundreds of powerful drugs used for cancer

chemotherapy, antiviral treatments, hormone regimens and other therapies. While these drugs are

used to relieve and heal patients, many of them present serious hazards to the health and safety of

your workers. Some of these drugs have been known to cause cancer, reproductive and

developmental problems, allergic reactions, and other adverse effects that can be irreversible even

after low-level exposures."

     (7) Further, because of the risk of ongoing exposure to these extremely hazardous

excreted drugs, the American Cancer Society has published a comprehensive list of safety

precautions regarding the in-home personal hygiene for individuals undergoing chemotherapy

and their families.

     (8) Therefore, for the protection of both the public health and the environment, the

general assembly shall require that standards are set forth pursuant to this section to address this

serious health and safety issue.

     (c) Chemotherapy precautions following treatment. All physicians, pharmacists, or other

health care professionals licensed in the state of Rhode Island authorized to prescribe and/or

administer chemotherapy treatment shall:

     (1) Provide written notice from the prescribing pharmacist to each patient undergoing

such treatment as to the hazards posed to patients and their families of extremely hazardous

excretions, including, but not limited to, urine, vomit, and feces, for a period following treatment

as generally determined by the food and drug administration label accompanying said

chemotherapy drug or drugs. To the extent such notices are generally consistent with those now

provided for patients undergoing treatment with radioactive drugs, or consistent with the

LC004776 - Page 8 of 25

recommendations of the World Health Organization with regard to cytotoxic drugs, or otherwise

consistent with similar standards that may be approved by the department of environmental

management in the context of a product stewardship plan adopted under chapter 19.16 of title 23,

then the prescribing pharmacist will not be held liable for the form of such notice;

     (2) Participate in an approved product stewardship program for the collection safe and

proper and disposal of Extremely Hazardous Wastes, including Cytotoxic Drugs and related

byproducts and wastes adopted pursuant to chapter 19.16 of title 23 so that providers and patients

can safely collect and contain extremely hazardous excretions for a period of time as determined

by the United States Food and Drug Administration ("FDA") and referenced on the relevant FDA

prescription insert(s).

     (d) Cytotoxic drug producers shall provide for the costs of managing and safely disposing

of the health care waste identified in this section in accordance with chapter 19.16 of title 23.

     (e) Receipt of notice from the party administering chemotherapy drugs or their agent

responsible for proper disposal of the hazardous wastes by the prescribing pharmacist or chief

pharmacist that the wastes have been disposed of in accordance with a product stewardship plan

shall satisfy the responsibility of the prescribing pharmacist hereunder.

     (f) For the purposes of this section, extremely hazardous excretions shall mean any

excretion from a patient on a regimen of chemotherapy agents that are antineoplastic or cytotoxic,

and which may be excreted during the period of administration or the time period referenced in

subsection (c)(2) of this section, including but not limited to, drugs listed in the NIOSH list of

Antineoplastic and Other Hazardous Drugs, as the same may be updated or amended from time to

time.

     SECTION 4. Chapter 27-20 of the General Laws entitled "Nonprofit Medical Service

Corporations" is hereby amended by adding thereto the following section:

     27-20-69. Cancer patient safety and environmental protection. -- (a) Purpose. It is the

policy of the state of Rhode Island not to permit introduction of pollutants into the ground waters

and water systems of the state or otherwise to be discharged in concentrations which are known to

be toxic, carcinogenic, mutagenic, or teratogenic as the same are defined in the Rhode Island

department of environmental management groundwater quality rules and the rules and regulations

for hazardous waste management. More specifically, the Rhode Island department of

environmental management, in regulation #OEM OWM-HW 01-14, most recent revision dated

January 7, 2014, defines certain antineoplastic or cytotoxic chemotherapy agents and drugs as

"extremely hazardous waste."

     (b) Findings. (1) It is acknowledged by medical experts that bodily wastes of patients

LC004776 - Page 9 of 25

undergoing chemotherapy treatment may contain levels of chemicals that are toxic, carcinogenic,

mutagenic or teratogenic for a certain period of time, to such an extent that the World Health

Organization defines genotoxic waste as chemotherapy drug waste including urine, feces and

vomit from patients, which may contain potentially hazardous amounts of the administered

cytostatic drugs or of their metabolites, and which should be considered genotoxic for at least

forty-eight (48) hours and sometimes up to one week after drug administration. According to the

World Health Organization, ten percent (10%) of known carcinogens are chemicals used to cure

cancer.

     (2) While, according to the American Society of Clinical Oncology, the cost of one

additional cancer patient resulting from the exposure to these harmful chemicals is approximately

one hundred seventy thousand dollars ($170,000) per treatment year, the cost of the

implementation of cytotoxic chemical safety protocols is estimated to be less than two percent

(2%) of that cost.

     (3) The World Health Organization further states that any discharge of genotoxic waste

into the environment could have disastrous ecological consequences. The World Health

Organization places the responsibility for genotoxic waste on the chief pharmacist and further

states that the chief pharmacist also has the special responsibility of ensuring that genotoxic

products are used safely, and that genotoxic waste is managed safely.

     (4) The European Commission, Executive Agency for Health and Consumers undertook a

comprehensive "Study on the Environmental Risks of Medicinal Products" which was released in

June of 2014, drafted by 810 Intelligence Service, a division of Deloitte Consulting LLP,

reviewing the prevalence of contaminants in drinking water and noting the extreme dangers

arising from improper disposal of cytotoxic chemotherapy drugs.

     (5) Dr. Christian G. Daughton, former chief of environmental chemistry for the United

States Environmental Protection Agency, notes in a paper entitled "Eco-directed Sustainable

Prescribing: Feasibility for Reducing Water Contamination by Drugs" published in the journal

"Science of the Total Environment" on June 3, 2014, that generally, the best practice for lowering

the level of drugs in our environment is reduction of dosages, but that "[c]ertain drug classes

(especially cytotoxic chemotherapeutics) may not be amenable to this approach; the best control

measure for such highly toxic drugs may simply be the prevention of urine and feces from

entering sewers."

     (6) The federal Occupational Safety and Health Administration ("OSHA") is the main

federal agency charged with the enforcement of safety and health legislation. OSHA, in concert

with the National Institute for Occupational Safety and Health ("NIOSH") and the Joint

LC004776 - Page 10 of 25

Commission on Healthcare, an independent, not-for-profit organization that accredits and certifies

more than twenty thousand (20,000) health care organizations and programs in the United States,

stated in a 2011 letter to every hospital in the country that "[e]very day in healthcare settings

across America, workers are exposed to hundreds of powerful drugs used for cancer

chemotherapy, antiviral treatments, hormone regimens and other therapies. While these drugs are

used to relieve and heal patients, many of them present serious hazards to the health and safety of

your workers. Some of these drugs have been known to cause cancer, reproductive and

developmental problems, allergic reactions, and other adverse effects that can be irreversible even

after low-level exposures."

     (7) Further, because of the risk of ongoing exposure to these extremely hazardous

excreted drugs, the American Cancer Society has published a comprehensive list of safety

precautions regarding the in-home personal hygiene for individuals undergoing chemotherapy

and their families.

     (8) Therefore, for the protection of both the public health and the environment, the

general assembly shall require that standards are set forth pursuant to this section to address this

serious health and safety issue.

     (c) Chemotherapy precautions following treatment. All physicians, pharmacists, or other

health care professionals licensed in the state of Rhode Island authorized to prescribe and/or

administer chemotherapy treatment shall:

     (1) Provide written notice from the prescribing pharmacist to each patient undergoing

such treatment as to the hazards posed to patients and their families of extremely hazardous

excretions, including, but not limited to, urine, vomit, and feces, for a period following treatment

as generally determined by the food and drug administration label accompanying said

chemotherapy drug or drugs. To the extent such notices are generally consistent with those now

provided for patients undergoing treatment with radioactive drugs, or consistent with the

recommendations of the World Health Organization with regard to cytotoxic drugs, or otherwise

consistent with similar standards that may be approved by the department of environmental

management in the context of a product stewardship plan adopted under chapter 19.16 of title 23,

then the prescribing pharmacist will not be held liable for the form of such notice;

     (2) Participate in an approved product stewardship program for the collection safe and

proper and disposal of Extremely Hazardous Wastes, including Cytotoxic Drugs and related

byproducts and wastes adopted pursuant to chapter 19.16 of title 23 so that providers and patients

can safely collect and contain extremely hazardous excretions for a period of time as determined

by the United States Food and Drug Administration ("FDA") and referenced on the relevant FDA

LC004776 - Page 11 of 25

prescription insert(s).

     (d) Cytotoxic drug producers shall provide for the costs of managing and safely disposing

of the health care waste identified in this section in accordance with chapter 19.16 of title 23.

     (e) Receipt of notice from the party administering chemotherapy drugs or their agent

responsible for proper disposal of the hazardous wastes by the prescribing pharmacist or chief

pharmacist that the wastes have been disposed of in accordance with a product stewardship plan

shall satisfy the responsibility of the prescribing pharmacist hereunder.

     (f) For the purposes of this section, extremely hazardous excretions shall mean any

excretion from a patient on a regimen of chemotherapy agents that are antineoplastic or cytotoxic,

and which may be excreted during the period of administration or the time period referenced in

subsection (c)(2) of this section, including but not limited to, drugs listed in the NIOSH list of

Antineoplastic and Other Hazardous Drugs, as the same may be updated or amended from time to

time.

     SECTION 5. Chapter 27-41 of the General Laws entitled "Health Maintenance

Organizations" is hereby amended by adding thereto the following section:

     27-41-86. Cancer patient safety and environmental protection. -- (a) Purpose. It is the

policy of the state of Rhode Island not to permit introduction of pollutants into the ground waters

and water systems of the state or otherwise to be discharged in concentrations which are known to

be toxic, carcinogenic, mutagenic, or teratogenic as the same are defined in the Rhode Island

department of environmental management groundwater quality rules and the rules and regulations

for hazardous waste management. More specifically, the Rhode Island department of

environmental management, in regulation #OEM OWM-HW 01-14, most recent revision dated

January 7, 2014, defines certain antineoplastic or cytotoxic chemotherapy agents and drugs as

"extremely hazardous waste."

     (b) Findings. (1) It is acknowledged by medical experts that bodily wastes of patients

undergoing chemotherapy treatment may contain levels of chemicals that are toxic, carcinogenic,

mutagenic or teratogenic for a certain period of time, to such an extent that the World Health

Organization defines genotoxic waste as chemotherapy drug waste including urine, feces and

vomit from patients, which may contain potentially hazardous amounts of the administered

cytostatic drugs or of their metabolites, and which should be considered genotoxic for at least

forty-eight (48) hours and sometimes up to one week after drug administration. According to the

World Health Organization, ten percent (10%) of known carcinogens are chemicals used to cure

cancer.

     (2) While, according to the American Society of Clinical Oncology, the cost of one

LC004776 - Page 12 of 25

additional cancer patient resulting from the exposure to these harmful chemicals is approximately

one hundred seventy thousand dollars ($170,000) per treatment year, the cost of the

implementation of cytotoxic chemical safety protocols is estimated to be less than two percent

(2%) of that cost.

     (3) The World Health Organization further states that any discharge of genotoxic waste

into the environment could have disastrous ecological consequences. The World Health

Organization places the responsibility for genotoxic waste on the chief pharmacist and further

states that the chief pharmacist also has the special responsibility of ensuring that genotoxic

products are used safely, and that genotoxic waste is managed safely.

     (4) The European Commission, Executive Agency for Health and Consumers undertook a

comprehensive "Study on the Environmental Risks of Medicinal Products" which was released in

June of 2014, drafted by 810 Intelligence Service, a division of Deloitte Consulting LLP,

reviewing the prevalence of contaminants in drinking water and noting the extreme dangers

arising from improper disposal of cytotoxic chemotherapy drugs.

     (5) Dr. Christian G. Daughton, former chief of environmental chemistry for the United

States Environmental Protection Agency, notes in a paper entitled "Eco-directed Sustainable

Prescribing: Feasibility for Reducing Water Contamination by Drugs" published in the journal

"Science of the Total Environment" on June 3, 2014, that generally, the best practice for lowering

the level of drugs in our environment is reduction of dosages, but that "[c]ertain drug classes

(especially cytotoxic chemotherapeutics) may not be amenable to this approach; the best control

measure for such highly toxic drugs may simply be the prevention of urine and feces from

entering sewers."

     (6) The federal Occupational Safety and Health Administration ("OSHA") is the main

federal agency charged with the enforcement of safety and health legislation. OSHA, in concert

with the National Institute for Occupational Safety and Health ("NIOSH") and the Joint

Commission on Healthcare, an independent, not-for-profit organization that accredits and certifies

more than twenty thousand (20,000) health care organizations and programs in the United States,

stated in a 2011 letter to every hospital in the country that "[e]very day in healthcare settings

across America, workers are exposed to hundreds of powerful drugs used for cancer

chemotherapy, antiviral treatments, hormone regimens and other therapies. While these drugs are

used to relieve and heal patients, many of them present serious hazards to the health and safety of

your workers. Some of these drugs have been known to cause cancer, reproductive and

developmental problems, allergic reactions, and other adverse effects that can be irreversible even

after low-level exposures."

LC004776 - Page 13 of 25

     (7) Further, because of the risk of ongoing exposure to these extremely hazardous

excreted drugs, the American Cancer Society has published a comprehensive list of safety

precautions regarding the in-home personal hygiene for individuals undergoing chemotherapy

and their families.

     (8) Therefore, for the protection of both the public health and the environment, the

general assembly shall require that standards are set forth pursuant to this section to address this

serious health and safety issue.

     (c) Chemotherapy precautions following treatment. All physicians, pharmacists, or other

health care professionals licensed in the state of Rhode Island authorized to prescribe and/or

administer chemotherapy treatment shall:

     (1) Provide written notice from the prescribing pharmacist to each patient undergoing

such treatment as to the hazards posed to patients and their families of extremely hazardous

excretions, including, but not limited to, urine, vomit, and feces, for a period following treatment

as generally determined by the food and drug administration label accompanying said

chemotherapy drug or drugs. To the extent such notices are generally consistent with those now

provided for patients undergoing treatment with radioactive drugs, or consistent with the

recommendations of the World Health Organization with regard to cytotoxic drugs, or otherwise

consistent with similar standards that may be approved by the department of environmental

management in the context of a product stewardship plan adopted under chapter 19.16 of title 23,

then the prescribing pharmacist will not be held liable for the form of such notice;

     (2) Participate in an approved product stewardship program for the collection safe and

proper and disposal of Extremely Hazardous Wastes, including Cytotoxic Drugs and related

byproducts and wastes adopted pursuant to chapter 19.16 of title 23 so that providers and patients

can safely collect and contain extremely hazardous excretions for a period of time as determined

by the United States Food and Drug Administration ("FDA") and referenced on the relevant FDA

prescription insert(s).

     (d) Cytotoxic drug producers shall provide for the costs of managing and safely disposing

of the health care waste identified in this section in accordance with chapter 19.16 of title 23.

     (e) Receipt of notice from the party administering chemotherapy drugs or their agent

responsible for proper disposal of the hazardous wastes by the prescribing pharmacist or chief

pharmacist that the wastes have been disposed of in accordance with a product stewardship plan

shall satisfy the responsibility of the prescribing pharmacist hereunder.

     (f) For the purposes of this section, extremely hazardous excretions shall mean any

excretion from a patient on a regimen of chemotherapy agents that are antineoplastic or cytotoxic,

LC004776 - Page 14 of 25

and which may be excreted during the period of administration or the time period referenced in

subsection (c)(2) of this section, including but not limited to, drugs listed in the NIOSH list of

Antineoplastic and Other Hazardous Drugs, as the same may be updated or amended from time to

time.

     SECTION 6. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby

amended by adding thereto the following chapter:

CHAPTER 19.16

SAFE CYTOTOXIC WASTE DISPOSAL ACT

     23-19.16-1. Short title. -- This section shall be known and may be cited as the "Safe

Cytotoxic Waste Disposal Act".

     23-19.16-2. Declaration of findings. -- (a) It is acknowledged by medical experts that

bodily wastes of patients undergoing chemotherapy treatment may contain levels of chemicals

that are toxic, carcinogenic, mutagenic or teratogenic for a certain period of time, to such an

extent that the World Health Organization defines genotoxic waste as chemotherapy drug waste

including urine, feces and vomit from patients, which may contain potentially hazardous amounts

of the administered cytostatic drugs or of their metabolites, and which should be considered

genotoxic for at least forty-eight (48) hours and sometimes up to one week after drug

administration. According to the World Health Organization, ten percent (10%) of known

carcinogens are chemicals used to cure cancer.

     (b) While, according to the American Society of Clinical Oncology, the cost of one

additional cancer patient resulting from the exposure to these harmful chemicals is approximately

one hundred seventy thousand dollars ($170,000) per treatment year, the cost of the

implementation of cytotoxic chemical safety protocols is estimated to be less than two percent

(2%) of that cost.

     (c) The World Health Organization further states that any discharge of genotoxic waste

into the environment could have disastrous ecological consequences. The World Health

Organization places the responsibility for genotoxic waste on the chief pharmacist and further

states that the chief pharmacist also has the special responsibility of ensuring that genotoxic

products are used safely, and that genotoxic waste is managed safely.

     (d) The European Commission, Executive Agency for Health and Consumers undertook a

comprehensive "Study on the Environmental Risks of Medicinal Products" which was released in

June of 2014, drafted by 810 Intelligence Service, a division of Deloitte Consulting LLP,

reviewing the prevalence of contaminants in drinking water and noting the extreme dangers

arising from improper disposal of cytotoxic chemotherapy drugs.

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     (e) Dr. Christian G. Daughton, former chief of environmental chemistry for the United

States Environmental Protection Agency, notes in a paper entitled "Eco-directed Sustainable

Prescribing: Feasibility for Reducing Water Contamination by Drugs" published in the journal

"Science of the Total Environment" on June 3, 2014, that generally, the best practice for lowering

the level of drugs in our environment is reduction of dosages, but that "[c]ertain drug classes

(especially cytotoxic chemotherapeutics) may not be amenable to this approach; the best control

measure for such highly toxic drugs may simply be the prevention of urine and feces from

entering sewers."

     (f) The federal Occupational Safety and Health Administration ("OSHA") is the main

federal agency charged with the enforcement of safety and health legislation. OSHA, in concert

with the National Institute for Occupational Safety and Health ("NIOSH") and the Joint

Commission on Healthcare, an independent, not-for-profit organization that accredits and certifies

more than twenty thousand (20,000) health care organizations and programs in the United States,

stated in a 2011 letter to every hospital in the country that "[e]very day in healthcare settings

across America, workers are exposed to hundreds of powerful drugs used for cancer

chemotherapy, antiviral treatments, hormone regimens and other therapies. While these drugs are

used to relieve and heal patients, many of them present serious hazards to the health and safety of

your workers. Some of these drugs have been known to cause cancer, reproductive and

developmental problems, allergic reactions, and other adverse effects that can be irreversible even

after low-level exposures."

     (g) Further, because of the risk of ongoing exposure to these extremely hazardous

excreted drugs, the American Cancer Society has published a comprehensive list of safety

precautions regarding the in-home personal hygiene for individuals undergoing chemotherapy

and their families.

     (h) Therefore, for the protection of both the public health and the environment, the

general assembly shall require that standards and rules be set forth pursuant to this section to

address this serious health and safety issue.

     23-19.16-3. Definitions. -- For the purposes of this chapter, the following terms shall

have the following meanings:

     (1) "Cytotoxic drugs" means, for purposes of this chapter, any drug defined by the

department as extremely hazardous waste or any waste byproduct or substance containing such a

drug.

     (2) "Department" means the Rhode Island department of environmental management.

     (3) "Drug wholesaler'' means a business that sells or distributes cytotoxic drugs for resale

LC004776 - Page 16 of 25

to an entity other than a consumer.

     (4) "Entity" means a person other than an individual.

     (5) "Mail-back program" means a system whereby residential generators of wastes from

cytotoxic drugs obtain prepaid and preaddressed shipping containers in which to place wastes for

shipment to an entity that will dispose of them safely and legally.

     (6) "Person" means an individual, firm, sole proprietorship, corporation, limited liability

corporation, general partnership, limited partnership, limited liability partnership, association,

cooperative, or other legal entity, however organized.

     (7) "Plan" or "product stewardship plan" means a product stewardship plan required

under this chapter that describes the manner in which a product stewardship program will be

provided.

     (8) "Producer" shall be determined, with regard to a cytotoxic drug that is sold, offered

for sale, or distributed in Rhode Island as meaning one of the following:

     (9)(i) The person who manufactures a cytotoxic drug and who sells, offers for sale, or

distributes that a cytotoxic drug in Rhode Island under that person's own name or brand.

     (ii) If there is no person who sells, offers for sale, or distributes the cytotoxic drug in

Rhode Island under the person's own name or brand, the producer of the cytotoxic drug is the

owner or licensee of a trademark or brand under which the cytotoxic drug is sold or distributed in

Rhode Island, whether or not the trademark is registered.

     (iii) If there is no person who is a producer of the cytotoxic drug for purposes of

subsection (8)(i) and (8)(ii), the producer of that cytotoxic drug is the person who brings the

cytotoxic drug into Rhode Island for sale or distribution. "producer" does not include:

     (A) A retailer that puts its store label on a cytotoxic drug; or

     (B) A pharmacist who dispenses prescription drugs to, or compounds a prescribed

individual drug product for a consumer.

     (10) "Product stewardship program" or "program" means a program financed and

operated by producers to collect, transport, and dispose of cytotoxic drugs.

     (11) "Residential generators" means residential or other locations outside a hospital

facility where cytotoxic drugs are or may be excreted, unused, unwanted, disposed of, or

abandoned.

     (12) "Stewardship organization" means an organization designated by a producer or a

group of producers to act as an agent on behalf of each producer to operate a product stewardship

program.

     23-19.16-4. Product stewardship program. -- (a) Requirement for sale. This chapter

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shall apply only to a producer whose cytotoxic drug is sold or distributed in Rhode Island. This

chapter shall be administered and implemented by the Rhode Island department of environmental

management. Each producer must:

     (1) Operate, individually or jointly with other producers, a product stewardship program

approved by the department; or

     (2) Enter into an agreement with a stewardship organization to operate, on the producer's

behalf, a product stewardship program approved by the department.

     (b) Product stewardship program costs.

     (1) A producer, group of producers, or stewardship organization must pay all

administrative and operational fees associated with their product stewardship program, including

the cost of collecting, transporting, and disposing of cytotoxic drugs collected from residential

generators and the proper disposal of packaging collected with the cytotoxic drugs.

     (2) A producer, group of producers, or stewardship organization must pay for all fees

associated with their specific product stewardship program and product stewardship plan.

     (3) No person or producer may charge a specific point-of-sale fee to consumers to recoup

the costs of their product stewardship program, nor may they charge a specific point-of-collection

fee at the time the unwanted products are collected from residential generators or delivered for

disposal.

     (4) A producer, group of producers, or stewardship organization must pay all costs

incurred by the state of Rhode Island, including but not limited to the department, in the

administration and enforcement of their product stewardship program. Exclusive of fines and

penalties, the state shall only recover its actual costs of administration and enforcement under this

chapter and shall not charge any amounts under this chapter in excess of its actual administrative

and enforcement costs.

     23-19.16-5. Product stewardship plans. -- (a) Plan content. Each product stewardship

program shall have a product stewardship plan that contains each of the following:

     (1) Certification that the product stewardship program will accept all cytotoxic drugs

regardless of who produced them, unless excused from this requirement by the department as part

of the approval of the plan;

     (2) Contact information for the individual and the entity submitting the plan and for each

of the producers participating in the product stewardship program;

     (3) A description of the methods by which cytotoxic drugs from residential generators

will be collected in Rhode Island and an explanation of how the collection system will be

convenient and adequate to serve the needs of Rhode Island residents;

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     (4) A description of how the product stewardship plan will provide collection services for

cytotoxic drugs for all patients in Rhode Island that are convenient and adequate to meet the

needs of patients and caregivers, including the option for all patients to utilize a mail-back

program;

     (5) The timing and method of delivery to patients of shipping containers for a mail-back

program;

     (6) A list containing the name, location, permit status, and record of any penalties,

violations, or regulatory orders received in the previous five (5) years by each person that will be

involved in transporting cytotoxic drugs and each disposal facility proposed to participate in the

product stewardship program;

     (7) A description of how the cytotoxic drugs will be safely and securely tracked and

handled from collection through final disposal and the policies and procedures to be followed to

ensure security;

     (8) A description of the public education and outreach activities to patients, caregivers,

and health care professionals, and how their effectiveness will be evaluated;

     (9) A description of education and outreach efforts to law enforcement, public safety, and

transportation officials and personal regarding the findings and requirements of this chapter, and

the process for safe handling and disposal of cytotoxic drugs and related wastes or byproducts

they may encounter;

     (10) A description of how the scope and extent of the product stewardship program can

reasonably be expected to identify and address each instance in which a cytotoxic drug is

prescribed in Rhode Island;

     (11) A starting date when collection of cytotoxic drugs will begin and, in the case of a

program utilizing a stewardship organization, the contracted term of engagement of that

stewardship organization;

     (12) If more than one producer will be involved in a proposed product stewardship

program, then the product stewardship plan for that program must include a fair and reasonable

manner for allocating the costs of the program among the participants in that program, such that

the portion of costs paid by each producer is reasonably related to the amount of cytotoxic drugs

that producer sells in the state of Rhode Island.

     (b) Department review and approval; updates.

     (1) Nothing herein shall prevent an existing producer, group of producers, or stewardship

organization from collecting cytotoxic drugs and related waste and byproducts prior to the

effective date hereof.

LC004776 - Page 19 of 25

     (2) Product stewardship plans must be submitted to the department for approval. The

initial plans must be submitted by December 1, 2016.

     (3) Within sixty (60) days after receipt of a product stewardship plan, the department

shall conduct a public hearing and determine whether the plan complies with the requirements of

this chapter and of any regulations adopted pursuant to this chapter.

     (i) The department may reject a plan within thirty (30) days of receipt without conducting

a public hearing.

     (ii) As part of its approval, the department may set reasonable performance goals for the

program.

     (iii) If the department approves a plan, it shall notify the applicant of its approval in

writing.

     (iv) If the department rejects a plan, it shall notify the applicant in writing of its reasons

for rejecting the Plan.

     (4) An applicant whose plan has been rejected by the department must submit a revised

plan to the department within sixty (60) days after receiving notice of the rejection.

     (5) If the department rejects a revised product stewardship plan or any other subsequently

revised plan, the producer(s) at issue shall be out of compliance with this chapter and are subject

to the enforcement provisions contained in this chapter.

     (6) At least every three (3) years, a producer, group of producers or stewardship

organization operating a product stewardship program shall update its product stewardship plan

and submit the updated plan to the department for review and approval.

     (7) A producer who begins to offer a cytotoxic drug for sale in the state of Rhode Island

after July 1, 2017, must submit a product stewardship plan to the department or provide evidence

of having joined an existing approved product stewardship program prior to the producer's initial

offer for sale of a cytotoxic drug.

     (8) Any proposed changes to a product stewardship Plan must be submitted in writing to

the department and approved by the department in writing prior to implementation of any change.

     23-19.16-6. Disposal of cytotoxic wastes. -- (a) Compliance with applicable law. Each

product stewardship program must comply with all local, state, and federal laws and regulations

applicable to its operations, including laws and regulations governing the disposal of extremely

hazardous wastes and their byproducts.

     (b) Protocols for packaging and transport of cytotoxic drugs and related wastes from

residential generators must address the destruction of pathogens and cytotoxins and the

conversion of wastes to a non-liquid form prior to shipping or transport.

LC004776 - Page 20 of 25

     (c) Cytotoxic drugs and related wastes shall not be incinerated.

     (d) Prior to shipment or transport from the location of the residential generator the

cytotoxic drugs, related wastes (including but not limited to protective equipment, medical

supplies, clothing, bedding) and other contaminated materials must be contained so as to not

result in exposure by handlers of the waste during shipment or transport.

     23-19.16-7. Reporting. -- (a) On or before July 1, 2017 (or at a later date as approved in

writing by the department) and in each subsequent year, every producer, group of producers, or

stewardship organization operating a product stewardship program must prepare and submit to

the department an annual written report describing the program's activities during the previous

reporting period. The report must include the following:

     (1) A list of producers participating in the product stewardship program;

     (2) The quantity of cytotoxic drugs collected from residential generators;

     (3) The name and location of disposal facilities at which cytotoxic drugs were disposed of

and the quantities disposed of at each facility;

     (4) Whether policies and procedures for collecting, transporting, and disposing of

cytotoxic drugs, as established in the plan, were followed during the reporting period and a

description of any noncompliance;

     (5) Whether any safety or security problems occurred during collection, transportation, or

disposal of cytotoxic drugs during the reporting period and, if so, what changes have or will be

made to policies, procedures, or tracking mechanisms to alleviate the problem and to improve

safety and security;

     (6) A description of public education and outreach activities implemented during the

reporting period, including the methodology used to evaluate the outreach and program activities;

     (7) How the product stewardship program complied with all other elements in the product

stewardship plan approved by the department, including its degree of success in meeting any

performance goals set by the department as part of its approval of the program; and

     (8) Any other information that the department may reasonably require.

     (b) For the purposes of this section, "reporting period" means the period beginning

January 1 and ending December 31 of the same calendar year.

     (c) List of producers. The department shall provide on its website a list of all producers

participating in product stewardship programs approved by the department and a list of all

producers the department has identified as noncompliant with this chapter or any regulations

adopted pursuant to this chapter.

     23-19.16-8. Regulations and fees. -- The director of the department of environmental

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management may, after a noticed public hearing, adopt such rules and regulations as necessary to

implement, administer, and enforce this chapter. Said regulations shall include a schedule of fees

to be charged to the producers to cover all of the state of Rhode Island's costs of administering

and enforcing this ordinance.

     23-19.16-9. Enforcement. -- (a) The department of environmental management shall

administer the penalty provisions of this chapter.

     (b) The department of environmental management may issue an administrative citation to

a producer for violation of this chapter or any regulation adopted pursuant to this chapter. The

department shall first send a written warning to the producer as well as a copy of this chapter and

any regulations adopted pursuant to this chapter. The producer shall have thirty (30) days after

receipt of the warning to comply and correct any violations.

     (c) If the producer fails to comply and correct any violations, the department may impose

administrative fines for violations of this chapter or of any regulations adopted pursuant to this

chapter. Each day shall constitute a separate violation for these purposes.

     (d) Any person in violation of this chapter or any regulation adopted pursuant to this

chapter shall be liable to the state of Rhode Island for a civil penalty in an amount not to exceed

one thousand dollars ($1,000) per day per violation. Each day in which the violation continues

shall constitute a separate and distinct violation.

     (e) In determining the appropriate penalties, the department of environmental

management shall consider the extent of harm caused by the violation, the nature and persistence

of the violation, the frequency of past violations, any action taken to mitigate the violation, and

the financial burden to the violator.

     (f) Any producer receiving an administrative citation under this chapter or any regulation

adopted pursuant to this chapter may appeal it within twenty-one (21) calendar days from the date

the administrative citation was issued. The administrative citation is deemed issued on the day it

is sent by first class mail or personal service. The administrative citation shall state the date of

issuance. If the deadline falls on a weekend or state holiday, then the deadline shall be extended

until the next regular business day. The request to appeal must:

     (1) Be in writing;

     (2) Be accompanied by a deposit of the total fine and any fees noted on the administrative

citation;

     (3) Specify the basis for the appeal in detail;

     (4) Be postmarked within twenty-one (21) days from the date the administrative citation

was issued; and

LC004776 - Page 22 of 25

     (5) Be sent to the address as set forth on the administrative citation.

     (g) The written request to appeal will be reviewed and, if found to be complete, a date,

time and place shall be set for a hearing before a hearing officer designated by the director of the

department of environmental management. Written notice of the time and place for the hearing

will be served by first class mail or personal service at least twenty-one (21) days prior to the date

of the hearing to the producer appealing the citation. Service by first class mail, postage prepaid

shall be effective on the date of mailing.

     (h) Failure of any producer to file an appeal in accordance with the provisions of this

section shall constitute waiver of that producer's rights to administrative determination of the

merits of the administrative citation and the amount of the fine and any fees and shall constitute a

failure by that producer to exhaust administrative remedies.

     (i) The producer requesting the appeal may request the director of the department of

environmental management to recuse a hearing officer for reasons of actual prejudice against the

party's cause. The hearing officer shall conduct an orderly, fair hearing and accept evidence as

follows:

     (1) A valid administrative citation shall be prima facie evidence of the violation;

     (2) Testimony shall be by declaration under penalty of perjury except to the extent the

hearing officer permits or requires live testimony concerning the violation.

     (3) The hearing officer may reduce, waive or conditionally reduce the fines and any fees

stated in the administrative citation. The hearing officer may impose deadlines or a schedule for

payment of the fine and any fees due in excess of the deposit.

     (4) The hearing officer shall make findings based on the record of the hearing and make a

written decision based on the findings ("hearing officer decision"). The hearing officer decision

shall be served by first class mail on the producer appealing and the department. The hearing

officer decision affirming or dismissing the administrative citation is final, unless a timely notice

of appeal is filed for hearing by the superior court of the state of Rhode Island.

     (j) A second appeal may be filed with the superior court within ten (10) calendar days

after the date of service of the hearing officer decision.

     (1) The appeal may be taken by any producer or the department within said ten (10) day

period, by filing with the clerk of the superior court a notice of appeal specifying the grounds for

such appeal.

     (2) Upon receiving an appeal, the department shall immediately arrange for an

administrative record to be made available to the superior court of all of the documents

constituting the record upon which the action appealed was taken.

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     (3) The superior court may hear additional evidence in its sole discretion and may

sustain, modify or overrule any order brought before it on appeal.

     (k) The department of environmental management may establish appropriate

administrative rules for implementing this chapter, conducting hearings, and rendering decisions

pursuant to this section.

     (l) Upon the failure of any producer to comply with any requirement of this chapter and

any rule or regulation adopted pursuant to this chapter, the Rhode Island attorney general's office

may petition any court having jurisdiction for injunctive relief, payment of civil penalties and any

other appropriate remedy, including restraining such person from continuing any prohibited

activity and compelling compliance with lawful requirements. However, this subsection does not

permit the department, the state of Rhode Island, or any court of competent jurisdiction to restrain

the sale of any cytotoxic drug in Rhode Island.

     (m) Any person who knowingly and willfully violates the requirements of this chapter or

any rule or regulation adopted pursuant to this chapter is guilty of a misdemeanor and may be

prosecuted by the Rhode Island attorney general's office. A conviction for a misdemeanor

violation under this chapter is punishable by a fine of not less than fifty dollars ($50.00) and not

more than five hundred ($500) for each day per violation, or by imprisonment for a period not to

exceed six (6) months, or by both such fine and imprisonment.

     23-19.16-10. Additional provisions. -- (a) Conflict with state or federal law. This

chapter shall be construed so as not to conflict with applicable federal or state laws, rules or

regulations.

     (b) Severability. If any of the provisions of this chapter or the application thereof to any

person or circumstance is held invalid, the remainder of those provisions, including the

application of such part or provisions to persons or circumstances other than those to which it is

held invalid shall not be affected thereby and shall continue in full force and effect. To this end,

the provisions of this chapter are severable.

     SECTION 7. The educational and public awareness provisions of this act shall take effect

upon passage. The requirements related to the implementation of product stewardship programs

and the enforcement provisions related thereto, along with any other provisions not already in

effect, shall take effect on July 1, 2017.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO INSURANCE -- ACCIDENT AND SICKNESS INSURANCE POLICIES

***

     This act would provide that protections related to the disposal of extremely hazardous

wastes generated by the use of toxic, carcinogenic, mutagenic, or teratogenic chemotherapy drugs

be implemented by pharmacists, physicians, health care providers, and insurers in the state of

Rhode Island.

     The act would also provide for a drug stewardship program to address procedures and

industry financing of the proper disposal of these extremely hazardous wastes.

     The educational and public awareness provisions of this act would take effect upon

passage. The requirements related to the implementation of product stewardship programs and the

enforcement provisions related thereto, along with any other provisions not already in effect,

would take effect on July 1, 2017.

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