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: | |
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 regulations |
8 | for hazardous waste management. More specifically, the Rhode Island department of |
9 | environmental management, in regulation #OEM 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 810 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. Christian 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) health care 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 |
| LC004776 - Page 2 of 25 |
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, vomit, and feces, 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 product stewardship plan adopted under chapter 19.16 of title 23, |
22 | then the prescribing pharmacist will not be held liable for the form of such notice; |
23 | (2) Participate in an approved product stewardship program for the collection safe and |
24 | proper and disposal of Extremely Hazardous Wastes, including Cytotoxic Drugs and related |
25 | byproducts and wastes adopted pursuant to chapter 19.16 of title 23 so that providers and patients |
26 | can safely collect and contain extremely hazardous excretions for a period of time as determined |
27 | by the 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 product stewardship plan |
34 | shall satisfy the responsibility of the prescribing pharmacist hereunder. |
| LC004776 - Page 3 of 25 |
1 | (f) For the purposes of this section, extremely hazardous excretions shall mean 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 #OEM 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 |
| LC004776 - Page 4 of 25 |
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 810 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. Christian 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. |
| LC004776 - Page 5 of 25 |
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, vomit, and feces, 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 product stewardship plan adopted under chapter 19.16 of title 23, |
13 | then the prescribing pharmacist will not be held liable for the form of such notice; |
14 | (2) Participate in an approved product stewardship program for the collection safe and |
15 | proper and disposal of Extremely Hazardous Wastes, including Cytotoxic Drugs and related |
16 | byproducts and wastes adopted pursuant to chapter 19.16 of title 23 so that providers and patients |
17 | can safely collect and contain extremely hazardous excretions for a period of time as determined |
18 | by the 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 product 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 |
| LC004776 - Page 6 of 25 |
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 regulations |
5 | for hazardous waste management. More specifically, the Rhode Island department of |
6 | environmental management, in regulation #OEM 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 810 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. Christian G. Daughton, former chief of environmental chemistry for the United |
34 | States Environmental Protection Agency, notes in a paper entitled "Eco-directed Sustainable |
| LC004776 - Page 7 of 25 |
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, vomit, and feces, 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 |
| LC004776 - Page 8 of 25 |
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 product stewardship plan adopted under chapter 19.16 of title 23, |
4 | then the prescribing pharmacist will not be held liable for the form of such notice; |
5 | (2) Participate in an approved product stewardship program for the collection safe and |
6 | proper and disposal of Extremely Hazardous Wastes, including Cytotoxic Drugs and related |
7 | byproducts and wastes adopted pursuant to chapter 19.16 of title 23 so that providers and patients |
8 | can safely collect and contain extremely hazardous excretions for a period of time as determined |
9 | by the 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 product 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 regulations |
30 | for hazardous waste management. More specifically, the Rhode Island department of |
31 | environmental management, in regulation #OEM 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 |
| LC004776 - Page 9 of 25 |
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 810 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. Christian 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 |
| LC004776 - Page 10 of 25 |
1 | Commission on Healthcare, an independent, not-for-profit organization that accredits and certifies |
2 | more than twenty thousand (20,000) health care 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, vomit, and feces, 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 product stewardship plan adopted under chapter 19.16 of title 23, |
29 | then the prescribing pharmacist will not be held liable for the form of such notice; |
30 | (2) Participate in an approved product stewardship program for the collection safe and |
31 | proper and disposal of Extremely Hazardous Wastes, including Cytotoxic Drugs and related |
32 | byproducts and wastes adopted pursuant to chapter 19.16 of title 23 so that providers and patients |
33 | can safely collect and contain extremely hazardous excretions for a period of time as determined |
34 | by the United States Food and Drug Administration ("FDA") and referenced on the relevant FDA |
| LC004776 - Page 11 of 25 |
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 product 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 regulations |
21 | for hazardous waste management. More specifically, the Rhode Island department of |
22 | environmental management, in regulation #OEM 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 |
| LC004776 - Page 12 of 25 |
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 810 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. Christian 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." |
| LC004776 - Page 13 of 25 |
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, vomit, and feces, 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 product stewardship plan adopted under chapter 19.16 of title 23, |
20 | then the prescribing pharmacist will not be held liable for the form of such notice; |
21 | (2) Participate in an approved product stewardship program for the collection safe and |
22 | proper and disposal of Extremely Hazardous Wastes, including Cytotoxic Drugs and related |
23 | byproducts and wastes adopted pursuant to chapter 19.16 of title 23 so that providers and patients |
24 | can safely collect and contain extremely hazardous excretions for a period of time as determined |
25 | by the 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 product 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, |
| LC004776 - Page 14 of 25 |
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 section 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 810 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. |
| LC004776 - Page 15 of 25 |
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 section to |
27 | address this serious health and safety issue. |
28 | 23-19.16-3. Definitions. -- For the purposes of this chapter, the following terms shall |
29 | have the following meanings: |
30 | (1) "Cytotoxic drugs" means, for purposes of this chapter, any drug defined by the |
31 | department as extremely hazardous waste or any waste byproduct or substance containing such a |
32 | drug. |
33 | (2) "Department" means the Rhode Island department of environmental management. |
34 | (3) "Drug wholesaler'' means a business that sells or distributes cytotoxic drugs for resale |
| LC004776 - Page 16 of 25 |
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 "product stewardship plan" means a product stewardship plan required |
10 | under this chapter that describes the manner in which a product 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 | (9)(i) The person who manufactures a cytotoxic drug and who sells, offers for sale, or |
15 | distributes that a 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 | subsection (8)(i) and (8)(ii), the producer of that cytotoxic drug is the person who brings the |
22 | cytotoxic drug into Rhode Island for sale or distribution. "producer" does not include: |
23 | (A) A retailer that puts its store label on a cytotoxic drug; or |
24 | (B) A pharmacist who dispenses prescription drugs to, or compounds a prescribed |
25 | individual drug product for a consumer. |
26 | (10) "Product stewardship program" or "program" means a program financed and |
27 | operated by producers to collect, transport, and dispose of cytotoxic drugs. |
28 | (11) "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 | (12) "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 product stewardship |
33 | program. |
34 | 23-19.16-4. Product stewardship program. -- (a) Requirement for sale. This chapter |
| LC004776 - Page 17 of 25 |
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 Rhode Island department of environmental |
3 | management. Each producer must: |
4 | (1) Operate, individually or jointly with other producers, a product stewardship program |
5 | approved by the department; or |
6 | (2) Enter into an agreement with a stewardship organization to operate, on the producer's |
7 | behalf, a product stewardship program approved by the department. |
8 | (b) Product stewardship program costs. |
9 | (1) A producer, group of producers, or stewardship organization must pay all |
10 | administrative and operational fees associated with their product 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 product stewardship program and product 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 product stewardship program, nor may they charge a specific point-of-collection |
17 | fee at the time the unwanted products are collected from residential generators or delivered for |
18 | 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 product 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. Product stewardship plans. -- (a) Plan content. Each product stewardship |
26 | program shall have a product stewardship plan that contains each of the following: |
27 | (1) Certification that the product 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 product 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; |
| LC004776 - Page 18 of 25 |
1 | (4) A description of how the product stewardship plan will provide collection services for |
2 | 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 | product 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 personal 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 product 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 product stewardship |
27 | program, then the product 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. |
| LC004776 - Page 19 of 25 |
1 | (2) Product stewardship plans must be submitted to the department for approval. The |
2 | initial plans must be submitted by December 1, 2016. |
3 | (3) Within sixty (60) days after receipt of a product 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 product stewardship plan or any other subsequently |
17 | revised plan, the producer(s) at issue shall be out of compliance with this chapter and are subject |
18 | 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 product 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 July 1, 2017, must submit a product stewardship plan to the department or provide evidence |
24 | of having joined an existing approved product stewardship program prior to the producer's initial |
25 | offer for sale of a cytotoxic drug. |
26 | (8) Any proposed changes to a product 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 | product 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 for packaging and transport of cytotoxic drugs and related wastes from |
33 | 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. |
| LC004776 - Page 20 of 25 |
1 | (c) Cytotoxic drugs and related wastes shall not be incinerated. |
2 | (d) Prior to shipment or transport from the location of the residential generator the |
3 | cytotoxic drugs, related wastes (including but not limited to protective equipment, medical |
4 | supplies, clothing, bedding) and other contaminated materials must be contained so as to not |
5 | result in exposure by handlers of the waste during shipment or transport. |
6 | 23-19.16-7. Reporting. -- (a) On or before July 1, 2017 (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 product 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 product 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 product stewardship program complied with all other elements in the product |
25 | stewardship plan approved by the department, including its degree of success in meeting any |
26 | 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 product 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 |
| LC004776 - Page 21 of 25 |
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 ordinance. |
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 |
| LC004776 - Page 22 of 25 |
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 | party's cause. The hearing officer shall conduct an orderly, fair hearing and accept evidence as |
15 | 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 decision |
24 | shall be served by first class mail on the producer appealing and the department. The hearing |
25 | officer decision affirming or dismissing the administrative citation is final, unless a timely notice |
26 | 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 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. |
| LC004776 - Page 23 of 25 |
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 requirement 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 ($50.00) 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. The educational and public awareness provisions of this act shall take effect |
28 | upon passage. The requirements related to the implementation of product stewardship programs |
29 | and the enforcement provisions related thereto, along with any other provisions not already in |
30 | effect, shall take effect on July 1, 2017. |
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| LC004776 - Page 24 of 25 |
EXPLANATION | |
BY THE LEGISLATIVE COUNCIL | |
OF | |
A N A C T | |
RELATING TO INSURANCE -- ACCIDENT AND SICKNESS INSURANCE POLICIES | |
*** | |
1 | This act would provide 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, health care providers, and insurers in the state of |
4 | Rhode Island. |
5 | The act would also provide for a drug stewardship program to address procedures and |
6 | industry financing of the proper disposal of these extremely hazardous wastes. |
7 | The educational and public awareness provisions of this act would take effect upon |
8 | passage. The requirements related to the implementation of product stewardship programs and the |
9 | enforcement provisions related thereto, along with any other provisions not already in effect, |
10 | would take effect on July 1, 2017. |
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| LC004776 - Page 25 of 25 |