PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action:
Addition of Part 4 to Title 10 NYCRR.
Statutory authority:
Public Health Law, section 225(5)(a)
Subject:
Protection Against Legionella.
Purpose:
To protect the public from the immediate threat posed by Legionella.
Substance of proposed rule (Full text is posted at the following State website:www.health.ny.gov):
The following summarizes the purpose and impact of each section. The summary is for convenience, and it is not a substitute for the express terms of the regulation.
• 4-1.1 Scope.
o Provides that the regulation applies to all owners of cooling towers.
• 4-1.2 Definitions.
o This section defines key terms.
o In particular, a “cooling tower” is now defined as: “a cooling tower, evaporative condenser, fluid cooler or other wet cooling device that is capable of aerosolizing water, and that is part of, or contains, a recirculated water system and is incorporated into a building’s cooling process, an industrial process, a refrigeration system, or an energy production system.”
o The definition of “owner” is now defined as follows: “any person, agent, firm, partnership, corporation or other legal entity having a legal or equitable interest in, or control of, a cooling tower or the premises where the cooling tower is located. In all instances, the legal owner of the building shall be deemed an owner within the meaning of the Subpart. Further, where a tenant owns a cooling tower that services the tenant’s leased premises, the tenant is an “owner” within the meaning of this Subpart. Additionally, if a tenant does not own the cooling tower but has a lease or contractual arrangement to maintain the cooling tower, the tenant shall be deemed an agent having control of the cooling tower, and thus an “owner,” for purposes of this Subpart.”
• 4-1.3 Electronic registration and reporting.
o Requires owners of cooling towers to register such towers with the Department using a statewide electronic system. Required registration fields have been slightly revised.
o Establishes a schedule for routine Legionella culture sampling and analysis, which includes reporting intervals not exceeding 90 days.
o Requires reporting of certain events, including:
- last bacteriological culture sample collection date and result;
- last Legionella culture sample collection date and result;
- date of any required remedial action;
- last inspection date;
- last certification date;
- date of removal or permanent discontinued use of a cooling tower; and
- cooling tower system volume (including any piping, basin, and sump).
o The proposed regulations generally require reporting of certain events every 90 days. This is a change from the emergency regulations, which required reporting within 10 days.
o Affords public access to the statewide electronic system, as appropriate, and requires such system to be accessible and searchable to local health departments.
o Clarifies that where both a landlord and a tenant are considered “owners” of a cooling tower pursuant to Section 4-1.2, then either the owner or the tenant shall register the cooling tower. Both parties, however, are obligated to ensure that registration and reporting are completed.
• 4-1.4 Maintenance program and plan.
o Requires owners to obtain or update the maintenance program and plan for all operational cooling towers by September 1, 2016, and prior to the startup of newly installed cooling towers. The plan must include the following elements:
- A schedule for routine bacteriological culture sampling and analysis to assess microbiological activity. The proposed regulation establishes a new, minimum sampling requirement, in which such sampling and analysis must be conducted: (1) at intervals not to exceed 30 days while the cooling tower is in use; and (2) at additional times, as needed, to validate process adjustments. The component that specifies a minimum sampling interval is a new requirement.
- The emergency regulation contained a requirement for a schedule of routine Legionella culture sampling and analysis. The new regulation requires sampling within two weeks of seasonal start-up and thereafter at intervals not to exceed 90 days. In addition, the new regulation requires that year-round use towers be sampled at intervals not to exceed 90 days and within two weeks after start-up following maintenance. These are new requirements.
- Provisions for immediate Legionella culture sampling and analysis following specified conditions, such as power failure, loss of biocide of sufficient duration to allow for the growth of bacteria, and if the State or local health department determines that one or more cases of Legionella is or may be associated with the tower. In addition to the conditions above, the proposed regulation describes conditions whereby the department or local health department may require sampling.
- Provisions requiring immediate and appropriate action, including any necessary remedial action, in response to bacteriological and Legionella culture analyses.
- Provisions requiring that any and all Legionella culture analysis must be performed in accordance with Section 4-1.5. This is a new requirement.
- Provisions for shutdown and for removing or permanently discontinuing use of a cooling tower. These are new requirements.
- Provisions requiring appropriate actions during idle conditions. This is a new requirement.
- Provisions requiring cleaning and disinfection of a cooling tower that has been shut down without treatment for more than five days. This is a new requirement.
• 4-1.5 Legionella culture analysis.
o Requires that Legionella culture analysis be performed by a laboratory that is approved to perform such analysis by the New York State Environmental Laboratory Approval Program (ELAP). This is a new requirement.
• 4-1.6 Notification.
o Requires an owner of a cooling tower to notify the local health department within 24 hours of receipt of a Legionella culture sample result that exceeds 1,000 Colony forming units (CFU) per milliliter. The owner must also notify the public of the test result in a manner determined by the local health department or by the department, if the department elects to determine the manner of public notification. This is a new requirement.
• 4-1.7 Disinfection.
o Establishes qualifications of persons who may disinfect a cooling tower.
o Requires that the name and certification number of the applicator or the business name and registration number of the company providing the disinfection be maintained on-site in accordance with Section 4-1.9. This is a new requirement.
o Permits only biocide products registered by the New York State Department of Environmental Conversation to be used in disinfection.
o “Disinfection” is clarified to exclude the cleaning of a cooling tower through application of detergents, penetrants, brushes or other tools, high-powered water, or any other method that does not involve the use of a pesticide, as defined in 6 NYCRR Part 325.
• 4-1.8 Inspection and certification.
o Inspection.
- Requires that all owners of cooling towers ensure that such towers are inspected prior to seasonal start up and at intervals not exceeding every 90 days while in use. Year-round towers shall be inspected at intervals not exceeding every 90 days and prior to start up following maintenance. The inspection requirement prior to start up is new.
o Certification.
- By November 1, 2016, and by November 1st of each year thereafter, the owner of a cooling tower must obtain a certification that the cooling tower has a maintenance program and plan, and that all activities within that plan or required by this Subpart were implemented.
o Reporting.
- All inspection findings, deficiencies, and corrective actions, and all certifications, must be reported to the owner. This section is new to the regulation.
• 4-1.9 Recordkeeping.
o Describes the records and documentation that the owner must maintain onsite for at least three years. Such records must be made available to the department or local health department upon request.
• 4-1.10 Enforcement.
o Provides that the department or local health department may require any owner to conduct Legionella culture sampling and analysis, following a determination, based upon epidemiologic or laboratory testing, that one or more cases of legionellosis are or may be associated with a cooling tower. This is a new provision.
o Permits an officer or employee of the department or local health department to enter onto any property to inspect a cooling tower for compliance with the requirements of this Subpart. The proposed regulation clarifies that such officers or employees may take water samples.
o Provides that a violation of any provision in this Subpart is subject to all civil and criminal penalties as provided for by law. Further, every day that an owner remains in violation of any provision constitutes a separate and distinct violation of such provision.
• 4-1.11 Variances and waivers.
o Grants local health departments authority to issue variances from this regulation, upon approval of the New York State Department of Health. The local and State health department must be satisfied that the variance will not present a danger to public health.
o The department may also grant general or specific waivers where it is satisfied that a waiver will not present a danger to public health.
• 4-1.12 Severability.
o Standard severability clause is included.
• Appendix 4-A
o This Appendix describes required responsive actions for Legionella culture test results. As compared to the emergency regulations, these regulations raise the threshold level for detecting Legionella in laboratory culture analyses, from ≥ 10 colony forming units per milliliter (CFU/mL) to ≥ 20 CFU/mL.
o Responsive actions have been updated and clarified. The term “acceptable improvement” was changed to an actual quantitative target of “< 20 CFU/mL.” Also, where an owner receives a laboratory Legionella culture analyses result ≥ 1000 CFU /mL, the owner must provide appropriate notifications per section 4-1.6.
o The footnotes for on-line decontamination and system decontamination were modified to allow the use of a halogen-based compounds (chlorine or bromine).
SUBPART 4-2 Covered Facilities
• 4-2.1 Scope.
o This Subpart addresses Legionella exposure in general hospitals and residential health care facilities (collectively, “covered facilities”). This area was addressed through section 4.11 of the emergency regulation.
• 4-2.2 Definitions.
o Defines key terms.
• 4-2.3 Environmental assessment.
o Requires covered facilities to perform an environmental assessment of the facility, using forms provided or approved by the department, no later than September 1, 2016, unless an environmental assessment was performed on or after September 1, 2015.
o Requires an annual update of the environmental assessment, and in specified conditions.
o Requires that copies of the completed environmental assessment form be retained in accordance with Section 4-2.6.
• 4-2.4 Sampling Plan.
o Requires that all covered facilities adopt and implement a sampling plan for their potable water systems by December 1, 2016, and that new covered facilities must adopt such plan prior to providing services.
o In addition to any sampling required by the sampling plan, Legionella culture sampling and analysis of the potable water system must occur immediately, as directed by the department, where (1) the department determines that one or more cases of legionellosis are, or may be, associated with the facility; and (2) under any other condition specified by the department.
o The sampling plan must be reviewed and updated annually, and in specified conditions.
o The proposed regulation requires that the sampling plan and sampling results be retained in accordance with Section 4-2.6 of this Subpart.
• 4-2.5 Legionella culture analysis.
o Legionella culture analyses must be performed by a laboratory approved to perform such analyses by the New York State Environmental Laboratory Program (ELAP).
• 4-2.6 Recordkeeping.
o Specifies that all records related to the environmental assessment, sampling plan, and associated sampling results must be retained for three years and must be made available immediately to the department upon request.
• 4-2.7 Enforcement.
o Authorizes the department to conduct an assessment and/or a Legionella culture sampling and analysis of the potable water system at any time.
o Provides that where an owner of a covered facility does not comply with any provision contained within this Subpart, the department may determine that such condition constitutes a violation and may take such action as authorized by law. Further, each day an owner is in violation of a provision constitutes a separate and distinct violation.
• 4-2.8 Variances and waivers.
o Grants the department authority to issue variances and waivers from this regulation, subject to specified conditions.
• 4-2.9 Severability.
o Standard severability clause is included.
• Appendix 4-B.
o This new appendix contains a table with comparison thresholds for routine Legionella culture sampling results. However, in the event that one or more cases of legionellosis are, or may be, associated with the facility, the sampling interpretation shall be in accordance with the direction of a qualified professional and the department.
Text of proposed rule and any required statements and analyses may be obtained from:
Katherine Ceroalo, DOH, Bureau of House Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.state.ny.us
Data, views or arguments may be submitted to:
Same as above.
Public comment will be received until:
45 days after publication of this notice.
Summary of Regulatory Impact Statement
Needs and Benefits:
Legionellosis describes any illness caused by exposure to Legionella bacteria, including Legionnaire’s Disease and Pontiac Fever. Potential sources of exposure to Legionella bacteria include water in the home, workplace, healthcare facilities or aerosol-producing devices in public places. Improper maintenance of cooling towers can contribute to the growth and dissemination of Legionella bacteria. Inadequate surveillance for Legionella bacteria in the potable water systems at general hospitals and residential health care facilities can also increase the risk of legionellosis.
Symptoms of legionellosis may include cough, shortness of breath, high fever, muscle aches, and headaches, and can result in pneumonia. Hospitalization is often required, and between 5 and 30% of cases are fatal. People at highest risk are those 50 years of age or older; current or former smokers; those with chronic lung diseases; those with weakened immune systems from diseases like cancer, diabetes, or kidney failure; and those who take drugs to suppress the immune system during chemotherapy or after an organ transplant. The number of cases of legionellosis reported in New York State between 2005 and 2014 increased 323%, compared to those reported in the previous ten-year period.
Outbreaks of legionellosis have been associated with cooling towers, as well as with the potable water systems of general hospitals and residential health care facilities. Subpart 4-1 of these regulations establish requirements for cooling towers relating to: registration, reporting and recordkeeping; testing; disinfection; maintenance; inspection; and certification of compliance. Subpart 4-2 of these regulations require general hospitals and residential health care facilities to implement an environmental assessment and Legionella sampling plan for their potable water systems and take necessary responsive actions.
These proposed regulations incorporate important clarifications and revisions from the emergency regulations initially adopted by the Public Health and Health Planning Council on August 17, 2015. In general, the Department organized and streamlined the language for concision and clarity. Certain sections were renumbered and related provisions consolidated. Further, the proposed regulations have been divided into two Subparts.
Costs:
Subpart 4-1
Building owners already incur costs for routine operation and maintenance of cooling towers. There will be some increased costs associated with sampling, inspection, and certification of cooling towers. These costs are detailed in the Regulatory Impact Statement.
State and local governments will incur costs for administration, implementation, and enforcement. Exact costs cannot be predicted at this time. However, some local costs may be offset through the collection of fees, fines and penalties authorized pursuant to this Part. Costs to State and local governments may be offset further by a reduction in the need to respond to community legionellosis outbreaks.
Subpart 4-2
General hospitals and residential healthcare facilities already incur costs associated with running infection control programs. The regulations would incur new costs for those facilities that are not already conducting annual environmental assessments, and would require all such facilities to adopt and implement a Legionella sampling plan. In many instances, facilities can complete the environmental assessment using existing hospital staff (maintenance, operations, and nursing staff). The cost of these requirements is expected to be offset by the reduced risk of Legionellosis in such facilities.
Regulatory Flexibility Analysis
Effect of Rule:
The rule will affect the owner of any building with a cooling tower, as those terms are defined in the regulation, which could include small businesses and local governments. Any general hospitals and residential health care facilities owned or operated by a local government or that qualifies as a small business will be required to complete an environmental assessment, adopt and implement a Legionella sampling plan for the facilities’ potable water system, and take appropriate responsive actions. At this time, it is not possible to determine the number of small businesses or local governments affected.
Local governments must also enforce Subpart 4-1, relating to regulation of cooling towers. Local governments have the power to enforce the provisions of the State Sanitary Code, including this new Part. PHL §§ 228, 229, 309(1)(f) and 324(1)(e).
Compliance Requirements:
Compliance requirement for small businesses and local governments are the same as those requirements set forth in the Regulatory Impact Statement.
Professional Services:
To comply with inspection and certification requirements with respect to cooling towers, small businesses and local governments will need to obtain services of a P.E., C.I.H., certified water technologist, or environmental consultant with training and experience performing inspections in accordance with current standard industry protocols including, but not limited to ASHRAE 188-2015. Small businesses and local governments will need to secure laboratory services for Legionella culture analysis. To comply with disinfection requirements with respect to cooling towers, small businesses and local governments will need to obtain the services of a commercial pesticide applicator or pesticide technician, or pesticide apprentice under supervision of a commercial pesticide applicator.
Compliance with the provisions that apply to general hospitals and healthcare facilities may require expertise in areas such engineering, physical facility management, water treatment methods, and monitoring of the environmental conditions of their potable water distribution systems.
Compliance Costs:
Compliance costs for small business and local government are consistent with the costs outlined in the Regulatory Impact Statement.
Economic and Technological Feasibility:
Although there will be an impact on building owners, including small businesses and local governments, compliance with the regulation is considered economically and technologically feasible, in part because the requirements are consistent industry best practices. This regulation is also necessary to protect public health, and it is expected to reduce cases of legionellosis in communities around cooling towers, as well as for patients and residents in general hospitals and residential healthcare facilities. Accordingly, the benefits to public health are anticipated to outweigh any costs.
Minimizing Adverse Impact:
The Department provides a cooling tower registry, technical consultation, coordination, and information and updates. In addition, the Department has issued guidance for general hospitals and cooling towers, which is consistent with the proposed regulations. Covered facilities that have followed the guidance will already be in compliance with most of the new regulations.
Small Business and Local Government Participation:
Development of the emergency regulations, upon which these regulations were based, was coordinated with New York City.
Cure Period:
Violation of this regulation can result in civil and criminal penalties. However, the regulations allow for time to adopt plans and performed required actions. Accordingly, and in light of the magnitude of the public health threat posed by Legionella, no cure period is warranted.
Rural Area Flexibility Analysis
Pursuant to Section 202-bb of the State Administrative Procedure Act (SAPA), a rural area flexibility analysis is not required. These provisions apply uniformly throughout New York State, including all rural areas. The proposed rule will not impose an adverse economic impact on rural areas, nor will it impose any disproportionate reporting, recordkeeping or other compliance requirements on public or private entities in rural areas.
Job Impact Statement
Nature of the Impact:
The New York State Department of Health (NYSDOH) expects there to be a positive impact on jobs or employment opportunities. The requirements in the regulation generally coincide with industry standards and manufacturers specification for the operation and maintenance of cooling towers. However, it is expected that a subset of owners have not adequately followed industry standards and will hire firms or individuals to assist them with compliance and to perform inspections and certifications.
Categories and Numbers Affected:
The Department anticipates no negative impact on jobs or employment opportunities as a result of the proposed regulations.
Regions of Adverse Impact:
The Department anticipates no negative impact on jobs or employment opportunities in any particular region of the state.
