This notice is intended: to serve as both a notice of emergency adoption and a notice of proposed rule making. The emergency rule will expire May 5, 2020.
Text of rule and any required statements and analyses may be obtained from: Katherine Ceroalo, DOH, Bureau of Program Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 4737488, email: regsqna@health.ny.gov
Data, views or arguments may be submitted to: Same as above.
Public comment will be received until: 60 days after publication of this notice.
This rule was not under consideration at the time this agency submitted its Regulatory Agenda for publication in the Register.
Regulatory Impact Statement
Statutory Authority:
Section 225 of the Public Health Law (“PHL”) authorizes the Public Health and Health Planning Council (PHHPC), subject to the approval of the Commissioner of Health (Commissioner) to establish and amend State Sanitary Code provisions relating to the designation of communicable diseases which are dangerous to public health, designation of diseases for which specimens shall be submitted for laboratory examination, and the nature of information required to be furnished by physicians in each case of communicable disease.
Legislative Objectives:
The legislative objective of PHL § 225 is, in part, to protect the public health by authorizing PHHPC, with the approval of the Commissioner, to designate communicable diseases, thereby permitting enhanced disease monitoring and authorizing isolation and quarantine measures, if necessary, to prevent further transmission.
Needs and Benefits:
The 2019 Novel Coronavirus (2019-nCoV) is a virus that was found to be the cause of an outbreak of respiratory illness in Wuhan, Hubei Province, China in December 2019. It is associated with mild to severe respiratory illness including symptoms of fever, cough, and difficulty breathing. People infected with the virus have had symptoms ranging from those that are mild (like a common cold) to severe pneumonia that requires medical care in a hospital and may be fatal.
As of February 3, 2020, 17,391 confirmed cases of 2019-nCoV were reported to the World Health Organization from 23 countries, including Canada and the United States, with 362 deaths reported.
On January 30, 2020 the World Health Organization designated the 2019-nCoV outbreak as a Public Health Emergency of International Concern, advising that further cases may appear in any country. On January 31, 2020, the Secretary of Health and Human Services determined that as a result of confirmed cases of 2019-nCoV in the United States, a public health emergency exists and has existed since January 27, 2020, nationwide.
If 2019-nCoV spreads in the general population, there could be severe public health consequences. On February 1, 2020, the New York State Commissioner of Health determined that 2019-nCoV is communicable, rapidly emergent and a significant threat to the public health, and designated 2019-nCoV as a communicable disease under 10 NYCRR Section 2.1. This designation will expire at the next scheduled meeting of the Public Health and Health Planning Council on February 6, 2020. Adding “severe or novel coronavirus” to the reportable disease list will confirm the Commissioner's designation and permit the Department of Health (Department) to systematically monitor for the disease and permit decisions about isolation or quarantine of suspect or confirmed cases to be made on a timely basis.
The regulation will also permit the Department to monitor and respond to other severe or novel coronavirus cases that may arise, including Middle East Respiratory Syndrome (MERS).
Costs:
Costs to Regulated Parties:
As 2019-nCoV is a newly emerging disease, it is not possible to accurately predict the extent of the outbreak or potential costs. In the event of the occurrence of 2019-nCoV cases, however, it is imperative to the public health that they be reported immediately and investigated thoroughly to curtail additional exposure and potential morbidity and mortality and to protect the public health.
The costs associated with implementing the reporting of this disease are lessened as reporting processes and forms already exist. Hospitals, practitioners and clinical laboratories are accustomed to reporting communicable disease to public health authorities.
Costs to Local and State Governments:
As 2019-nCoV is a newly emerging disease, it is not possible to accurately predict the extent of the outbreak or potential costs.
Costs to local or state governments associated with investigating and implementing control strategies to curtail the spread of 2019-nCoV, however, could be significant. Control efforts may include isolation or quarantine. Close contacts of individuals diagnosed with 2019-nCoV may need to be closely monitored with daily follow-up by local health departments for up to two weeks post-exposure. These intensive efforts are critical to minimize the spread of this disease.
However, by potentially decreasing the spread of 2019-nCoV, this regulation may reduce costs associated with public health control activities, morbidity, treatment and premature death.
Costs to the Department of Health:
As 2019-nCoV is a newly emerging disease, it is not possible to accurately predict the extent of the outbreak or potential costs. Costs to the Department associated with assisting local health departments investigating and implementing control strategies to curtail the spread of 2019nCoV, however, could be significant.
Paperwork:
The existing general communicable disease reporting form (DOH-389) will be revised. This form is familiar to and is already used by regulated parties.
Local Government Mandates:
Under Part 2 of the State Sanitary Code (10 NYCRR Part 2), the city, county or district health officer receiving reports from physicians in attendance on persons with or suspected of being affected with 2019-nCoV, will be required to immediately forward such reports to the State Health Commissioner and to investigate and monitor the cases reported.
Duplication:
There is no duplication of this initiative in existing State or federal law.
Alternatives:
No other alternatives are available, because reporting of cases of 2019nCoV is of critical importance to public health. There is an urgent need to conduct surveillance, identify human cases in a timely manner, and reduce the potential for further exposure to contacts.
Federal Standards:
Currently there are no federal standards requiring the reporting of 2019nCoV.
Compliance Schedule:
Reporting of 2019-nCoV is currently mandated, pursuant to the authority vested in the Commissioner of Health by 10 NYCRR Section 2.1(a). This mandate will be extended upon filing of a Notice of Emergency Adoption of this regulation with the Secretary of State and made permanent by publication of a Notice of Adoption of this regulation in the New York State Register.