2015 -- S 0169 SUBSTITUTE A

========

LC000793/SUB A

========

     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2015

____________

A N   A C T

RELATING TO INSURANCE - ACCIDENT AND SICKNESS INSURANCE POLICIES

     

     Introduced By: Senators Ottiano, and Archambault

     Date Introduced: February 05, 2015

     Referred To: Senate Health & Human Services

     (by request)

It is enacted by the General Assembly as follows:

1

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

2

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

3

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

4

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

5

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

6

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

7

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

8

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

9

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

10

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

11

"extremely hazardous waste."

12

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

13

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

14

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

15

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

16

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

17

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

18

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

19

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

 

1

cancer.

2

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

3

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

4

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

5

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

6

(2%) of that cost.

7

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

8

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

9

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

10

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

11

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

12

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

13

comprehensive "Study on the environmental risks of medicinal products" which was released in

14

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

15

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

16

arising from improper disposal of cytotoxic chemotherapy drugs.

17

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

18

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

19

prescribing: feasibility for reducing water contamination by drugs" published in the journal

20

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

21

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

22

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

23

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

24

entering sewers."

25

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

26

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

27

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

28

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

29

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

30

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

31

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

32

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

33

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

34

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

 

LC000793/SUB A - Page 2 of 24

1

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

2

after low-level exposures."

3

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

4

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

5

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

6

and their families.

7

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

8

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

9

serious health and safety issue.

10

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

11

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

12

administer chemotherapy treatment shall:

13

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

14

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

15

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

16

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

17

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

18

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

19

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

20

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

21

management in the context of a producer stewardship plan adopted under chapter 19.16 of title

22

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

23

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

24

proper disposal of extremely hazardous wastes, including cytotoxic drugs and related byproducts

25

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

26

collect and contain extremely hazardous excretions for a period of time as determined by the

27

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

28

prescription insert(s).

29

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

30

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

31

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

32

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

33

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

34

shall satisfy the responsibility of the prescribing pharmacist hereunder.

 

LC000793/SUB A - Page 3 of 24

1

     (f) For the purposes of this section, "extremely hazardous excretions" means any

2

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

3

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

4

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

5

antineoplastic and other hazardous drugs, as the same may be updated or amended from time to

6

time.

7

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

8

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

9

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

10

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

11

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

12

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

13

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

14

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

15

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

16

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

17

"extremely hazardous waste."

18

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

19

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

20

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

21

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

22

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

23

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

24

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

25

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

26

cancer.

27

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

28

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

29

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

30

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

31

(2%) of that cost.

32

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

33

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

34

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

 

LC000793/SUB A - Page 4 of 24

1

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

2

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

3

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

4

comprehensive "Study on the environmental risks of medicinal products" which was released in

5

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

6

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

7

arising from improper disposal of cytotoxic chemotherapy drugs.

8

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

9

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

10

prescribing: feasibility for reducing water contamination by drugs" published in the journal

11

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

12

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

13

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

14

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

15

entering sewers."

16

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

17

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

18

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

19

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

20

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

21

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

22

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

23

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

24

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

25

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

26

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

27

after low-level exposures."

28

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

29

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

30

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

31

and their families.

32

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

33

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

34

serious health and safety issue.

 

LC000793/SUB A - Page 5 of 24

1

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

2

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

3

administer chemotherapy treatment shall:

4

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

5

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

6

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

7

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

8

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

9

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

10

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

11

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

12

management in the context of a producer stewardship plan adopted under chapter 19.16 of title

13

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

14

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

15

proper disposal of extremely hazardous wastes, including cytotoxic drugs and related byproducts

16

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

17

collect and contain extremely hazardous excretions for a period of time as determined by the

18

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

19

prescription insert(s).

20

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

21

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

22

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

23

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

24

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

25

shall satisfy the responsibility of the prescribing pharmacist hereunder.

26

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

27

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

28

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

29

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

30

antineoplastic and other hazardous drugs, as the same may be updated or amended from time to

31

time.

32

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

33

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

34

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

 

LC000793/SUB A - Page 6 of 24

1

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

2

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

3

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

4

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

5

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

6

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

7

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

8

"extremely hazardous waste."

9

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

10

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

11

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

12

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

13

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

14

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

15

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

16

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

17

cancer.

18

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

19

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

20

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

21

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

22

(2%) of that cost.

23

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

24

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

25

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

26

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

27

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

28

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

29

comprehensive "Study on the environmental risks of medicinal products" which was released in

30

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

31

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

32

arising from improper disposal of cytotoxic chemotherapy drugs.

33

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

34

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

 

LC000793/SUB A - Page 7 of 24

1

prescribing: feasibility for reducing water contamination by drugs" published in the journal

2

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

3

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

4

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

5

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

6

entering sewers."

7

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

8

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

9

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

10

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

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

after low-level exposures."

19

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

20

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

21

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

22

and their families.

23

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

24

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

25

serious health and safety issue.

26

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

27

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

28

administer chemotherapy treatment shall:

29

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

30

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

31

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

32

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

33

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

34

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

 

LC000793/SUB A - Page 8 of 24

1

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

2

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

3

management in the context of a producer stewardship plan adopted under chapter 19.16 of title

4

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

5

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

6

proper disposal of extremely hazardous wastes, including cytotoxic drugs and related byproducts

7

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

8

collect and contain extremely hazardous excretions for a period of time as determined by the

9

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

10

prescription insert(s).

11

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

12

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

13

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

14

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

15

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

16

shall satisfy the responsibility of the prescribing pharmacist hereunder.

17

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

18

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

19

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

20

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

21

antineoplastic and other hazardous drugs, as the same may be updated or amended from time to

22

time.

23

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

24

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

25

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

26

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

27

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

28

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

29

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

30

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

31

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

32

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

33

"extremely hazardous waste."

34

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

 

LC000793/SUB A - Page 9 of 24

1

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

2

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

3

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

4

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

5

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

6

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

7

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

8

cancer.

9

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

10

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

11

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

12

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

13

(2%) of that cost.

14

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

15

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

16

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

17

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

18

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

19

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

20

comprehensive "Study on the environmental risks of medicinal products" which was released in

21

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

22

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

23

arising from improper disposal of cytotoxic chemotherapy drugs.

24

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

25

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

26

prescribing: feasibility for reducing water contamination by drugs" published in the journal

27

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

28

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

29

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

30

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

31

entering sewers."

32

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

33

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

34

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

 

LC000793/SUB A - Page 10 of 24

1

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

2

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

3

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

4

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

5

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

6

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

7

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

8

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

9

after low-level exposures."

10

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

11

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

12

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

13

and their families.

14

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

15

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

16

serious health and safety issue.

17

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

18

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

19

administer chemotherapy treatment shall:

20

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

21

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

22

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

23

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

24

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

25

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

26

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

27

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

28

management in the context of a producer stewardship plan adopted under chapter 19.16 of title

29

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

30

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

31

proper disposal of extremely hazardous wastes, including cytotoxic drugs and related byproducts

32

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

33

collect and contain extremely hazardous excretions for a period of time as determined by the

34

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

 

LC000793/SUB A - Page 11 of 24

1

prescription insert(s).

2

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

3

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

4

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

5

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

6

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

7

shall satisfy the responsibility of the prescribing pharmacist hereunder.

8

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

9

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

10

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

11

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

12

antineoplastic and other hazardous drugs, as the same may be updated or amended from time to

13

time.

14

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

15

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

16

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

17

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

18

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

19

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

20

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

21

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

22

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

23

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

24

"extremely hazardous waste."

25

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

26

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

27

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

28

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

29

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

30

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

31

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

32

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

33

cancer.

34

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

 

LC000793/SUB A - Page 12 of 24

1

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

2

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

3

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

4

(2%) of that cost.

5

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

6

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

7

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

8

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

9

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

10

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

11

comprehensive "Study on the environmental risks of medicinal products" which was released in

12

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

13

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

14

arising from improper disposal of cytotoxic chemotherapy drugs.

15

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

16

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

17

prescribing: feasibility for reducing water contamination by drugs" published in the journal

18

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

19

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

20

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

21

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

22

entering sewers."

23

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

24

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

25

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

26

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

27

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

28

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

29

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

30

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

31

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

32

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

33

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

34

after low-level exposures."

 

LC000793/SUB A - Page 13 of 24

1

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

2

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

3

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

4

and their families.

5

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

6

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

7

serious health and safety issue.

8

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

9

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

10

administer chemotherapy treatment shall:

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

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

19

management in the context of a producer stewardship plan adopted under chapter 19.16 of title

20

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

21

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

22

proper disposal of extremely hazardous wastes, including cytotoxic drugs and related byproducts

23

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

24

collect and contain extremely hazardous excretions for a period of time as determined by the

25

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

26

prescription insert(s).

27

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

28

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

29

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

30

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

31

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

32

shall satisfy the responsibility of the prescribing pharmacist hereunder.

33

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

34

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

 

LC000793/SUB A - Page 14 of 24

1

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

2

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

3

antineoplastic and other hazardous drugs, as the same may be updated or amended from time to

4

time.

5

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

6

amended by adding thereto the following chapter:

7

CHAPTER 19.16

8

SAFE CYTOTOXIC WASTE DISPOSAL ACT

9

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

10

Cytotoxic Waste Disposal Act".

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

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

19

carcinogens are chemicals used to cure cancer.

20

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

21

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

22

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

23

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

24

(2%) of that cost.

25

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

26

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

27

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

28

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

29

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

30

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

31

comprehensive "Study on the environmental risks of medicinal products" which was released in

32

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

33

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

34

arising from improper disposal of cytotoxic chemotherapy drugs.

 

LC000793/SUB A - Page 15 of 24

1

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

2

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

3

prescribing: feasibility for reducing water contamination by drugs" published in the journal

4

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

5

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

6

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

7

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

8

entering sewers."

9

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

10

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

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

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

19

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

20

after low-level exposures."

21

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

22

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

23

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

24

and their families.

25

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

26

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

27

address this serious health and safety issue.

28

     23-19.16-3. Definitions. -- (a) For the purposes of this chapter the following terms shall

29

mean:

30

     (1) "Cytotoxic drugs" means any drug defined by the department as extremely hazardous

31

waste or any waste byproduct or substance containing such a drug.

32

     (2) "Department" means the department of environmental management as established in

33

chapter 17.1 of title 42.

34

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

 

LC000793/SUB A - Page 16 of 24

1

to an entity other than a consumer.

2

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

3

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

4

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

5

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

6

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

7

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

8

cooperative, or other legal entity, however organized.

9

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

10

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

11

provided.

12

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

13

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

14

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

15

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

16

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

17

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

18

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

19

Rhode Island, whether or not the trademark is registered;

20

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

21

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

22

cytotoxic drug into Rhode Island for sale or distribution.

23

     (iv) Provided the term "producer" does not include: (A) A retailer that puts its store label

24

on cytotoxic drugs; or (B) A pharmacist who dispenses prescription drugs to, or compounds a

25

prescribed individual drug product for a consumer.

26

     (9) "Producer stewardship program" or "program" means a program financed and

27

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

28

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

29

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

30

abandoned.

31

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

32

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

33

stewardship program.

34

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

 

LC000793/SUB A - Page 17 of 24

1

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

2

chapter shall be administered and implemented by the department of environmental management.

3

Each producer must:

4

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

5

program approved by the department; or

6

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

7

behalf, a producer stewardship program approved by the department.

8

     (b) Producer stewardship program costs.

9

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

10

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

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

delivered for disposal.

19

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

20

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

21

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

22

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

23

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

24

and enforcement costs.

25

     23-19.16-5. Producer stewardship plans. -- (a) Plan content. Each producer stewardship

26

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

27

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

28

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

29

of the approval of the plan;

30

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

31

of the producers participating in the producer stewardship program;

32

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

33

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

34

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

 

LC000793/SUB A - Page 18 of 24

1

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

2

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

3

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

4

program;

5

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

6

program;

7

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

8

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

9

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

10

producer stewardship program;

11

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

12

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

13

ensure security;

14

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

15

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

16

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

17

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

18

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

19

they may encounter;

20

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

21

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

22

prescribed in Rhode Island;

23

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

24

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

25

stewardship organization;

26

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

27

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

28

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

29

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

30

that producer sells in the state of Rhode Island.

31

     (b) Department review and approval; updates.

32

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

33

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

34

effective date hereof.

 

LC000793/SUB A - Page 19 of 24

1

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

2

initial plans must be submitted by October 1, 2016.

3

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

4

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

5

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

6

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

7

a public hearing.

8

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

9

program.

10

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

11

writing.

12

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

13

for rejecting the plan.

14

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

15

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

16

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

17

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

18

and will be subject to the enforcement provisions contained in this chapter.

19

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

20

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

21

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

22

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

23

after December 1, 2015, must submit a producer stewardship plan to the department or provide

24

evidence of having joined an existing approved producer stewardship program prior to the

25

producer's initial offer for sale of a cytotoxic drug.

26

     (8) Any proposed changes to a producer stewardship plan must be submitted in writing to

27

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

28

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

29

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

30

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

31

hazardous wastes and their byproducts.

32

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

33

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

34

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

 

LC000793/SUB A - Page 20 of 24

1

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

2

     (d) Containment of wastes. Prior to shipment or transport from the location of the

3

residential generator, the cytotoxic drugs, related wastes (including, but not limited to, protective

4

equipment, medical supplies, clothing, bedding) and other contaminated materials must be

5

contained so as to not result in exposure by handlers of the waste during shipment or transport.

6

     23-19.16-7. Reporting. -- (a) On or before July 1, 2016 (or at a later date as approved in

7

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

8

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

9

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

10

reporting period. The report must include the following:

11

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

12

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

13

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

14

and the quantities disposed of at each facility;

15

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

16

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

17

description of any noncompliance;

18

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

19

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

20

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

21

safety and security;

22

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

23

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

24

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

25

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

26

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

27

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

28

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

29

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

30

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

31

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

32

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

33

adopted pursuant to this chapter.

34

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

 

LC000793/SUB A - Page 21 of 24

1

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

2

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

3

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

4

and enforcing this chapter.

5

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

6

administer the penalty provisions of this chapter.

7

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

8

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

9

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

10

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

11

receipt of the warning to comply and correct any violations.

12

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

13

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

14

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

15

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

16

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

17

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

18

shall constitute a separate and distinct violation.

19

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

20

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

21

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

22

the financial burden to the violator.

23

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

24

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

25

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

26

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

27

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

28

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

29

     (1) Be in writing;

30

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

31

citation;

32

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

33

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

34

was issued; and

 

LC000793/SUB A - Page 22 of 24

1

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

2

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

3

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

4

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

5

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

6

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

7

shall be effective on the date of mailing.

8

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

9

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

10

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

11

failure by that producer to exhaust administrative remedies.

12

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

13

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

14

person or entity’s cause. The hearing officer shall conduct an orderly, fair hearing and accept

15

evidence as follows:

16

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

17

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

18

hearing officer permits or requires live testimony concerning the violation;

19

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

20

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

21

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

22

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

23

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

24

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

25

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

26

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

27

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

28

after the date of service of the hearing officer's decision.

29

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

30

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

31

such appeal.

32

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

33

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

34

constituting the record upon which the action appealed was taken.

 

LC000793/SUB A - Page 23 of 24

1

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

2

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

3

     (k) The department of environmental management may establish appropriate

4

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

5

pursuant to this section.

6

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

7

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

8

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

9

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

10

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

11

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

12

the sale of any cytotoxic drug in Rhode Island.

13

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

14

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

15

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

16

violation under this chapter is punishable by a fine of not less than fifty dollars ($50) and not

17

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

18

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

19

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

20

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

21

regulations.

22

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

23

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

24

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

25

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

26

the provisions of this chapter are severable.

27

     SECTION 7. Section 6 of this act shall take effect upon on July 1, 2016. The remaining

28

sections of this act shall take effect upon passage.

========

LC000793/SUB A

========

 

LC000793/SUB A - Page 24 of 24

EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO INSURANCE - ACCIDENT AND SICKNESS INSURANCE POLICIES

***

1

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

2

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

3

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

4

Rhode Island.

5

     Further, this act would provide for a drug stewardship program to address procedures and

6

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

7

     Section 6 of this act would take effect upon on July 1, 2016. The remaining sections of

8

this act would take effect upon passage.

========

LC000793/SUB A

========

 

LC000793/SUB A - Page 25 of 24