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Department of Health and Mental Hygiene
Codified Title: 
Title 24: Department of Health and Mental Hygiene

Proposed Rules: Closed to Comments (View Public Comments Received:1)

Agency:
Comment By: 
Monday, April 21, 2014
Proposed Rules Content: 

 

Statement of Basis and Purpose

 

Article 141 of the New York City Health Code (the “Health Code”) concerns the maintenance of the purity and sanitary condition of the City’s potable water supply. Water for thousands of New York City buildings is kept in water storage tanks. Health Code section 141.07 (“Building Drinking Water Storage Tanks”) requires that these tanks be inspected annually and that the person in control of a building serviced by a water storage tank keep copies of the inspection records and make them available to the New York City Department of Health and Mental Hygiene (the “Department”) upon request.

 

This proposed amendment would require building owners to document annually with the Department that their drinking water tanks have been inspected as required by section 141.07 of the Health Code and section 17-194 of the Administrative Code of the City of New York.  The Department would be authorized to indicate by rule the manner and form in which building owners would submit such documentation.

 

This amendment requires owners of buildings with water tanks to report annually to the Department on the fact that the tanks have been inspected as required by the Health Code. The amendment authorizes the Department to issue rules dictating the manner and form of these reports. Requiring annual reporting would promote building owner compliance with the inspection mandate and facilitate the Department’s ability to monitor compliance.  Data from these reports submitted to the Department will be made publically available

Subject: 

Proposed resolution to amend Article 141 of the Health Code to require building owners to demonstrate that the annual inspections of drinking water tanks as mandated by the New York City Health Code and the Administrative Code of the City of New York have been completed, and to authorize the Department to publish rules dictating the manner and form for submitting that documentation.

Location: 
New York City Department of Health and Mental Hygiene, Gotham Center
42-09 28th Street 3rd Floor, Room 3-32
Queens, NY 11101
Contact: 

Svetlana Burdeynik at (347) 396-6078 or resolutioncomments@health.nyc.gov
New York City Department of Health and Mental Hygiene
Gotham Center, 42-09 28th Street, CN 31
Long Island City, NY 11101-4132

Download Copy of Proposed Rule (.pdf): 

Proposed Rules: Closed to Comments

Agency:
Comment By: 
Monday, April 21, 2014
Proposed Rules Content: 

Statement of Basis and Purpose of the Proposed Amendment

 

The authority for these amendments is found in §§556 and 558 of the New York City Charter.   Sections 558(b) and (c) of the Charter empower the Board of Health to amend the Health Code and to include in the New York City Health Code (the “Health Code”) all matters to which the Department’s authority extends. Section 1043 grants the Department rule-making authority. 

 

    The Charter provides the New York City Department of Health and Mental Hygiene (the “Department” or “DOHMH”) with jurisdiction to protect and promote the health of all New Yorkers.

The Bureau of Child Care, in the Department’s Division of Environmental Health, enforces Article 47 (Child Care Services) of the Health Code, which regulates all public and private group day care services providing care for children under six years of age. Health and safety standards for school-based programs for children ages three through five are established in Article 43 of the Health Code.     

At its meeting on December 10, 2013, the Board of Health amended Articles 43 and 47 to add a new requirement that children between 6 and 59 months of age attending school based programs and child care services receive annual influenza vaccinations.  The resolution as adopted contained a drafting error in §47.25(a)(2)(C), which used the term “school” instead of “permittee,” to refer to the entity holding a child care service permit.   

The Department is requesting that the Board amend Article 47 to correct the error and substitute the term “permittee” for “school” in this provision.

 

Subject: 
Download Copy of Proposed Rule (.pdf): 

Proposed Rules: Closed to Comments (View Public Comments Received:1)

Agency:
Comment By: 
Wednesday, April 23, 2014
Proposed Rules Content: 

Statement of Basis and Purpose

 

Statutory Authority

 

These amendments to the New York City Health Code (the Health Code) are promulgated pursuant to §§558 and 1043 of the New York City Charter (the Charter).  Sections 558(b) and (c) of the Charter empower the Board of Health (the Board) to amend the Health Code and to include in the Health Code all matters to which the authority of the New York City Department of Health and Mental Hygiene (the Department) extends. Section 1043 grants the Department rule-making authority.  Further, New York State Public Health law §580(3) permits the Department to “enact or enforce additional laws, codes or regulations affecting clinical laboratories…related to the control, prevention or reporting of diseases or medical conditions or to the control or abatement of public health nuisances.”

 

Background

 

The Charter provides the Department with jurisdiction over all matters concerning health in the City of New York.  The Department’s Division of Disease Control conducts disease surveillance and control activities for most of the diseases listed in Article 11 of the New York City Health Code (Health Code). The Department’s Divisions of Epidemiology, Healthcare Access and Improvement, Health Promotion and Disease Prevention, and Environmental Health also conduct surveillance and control activities for various reportable diseases and conditions.  The Department is also required to comply with various provisions of Chapter 1 of the New York State Sanitary Code (the Sanitary Code), found in Title 10 of the Codes, Rules and Regulations of the State of New York (NYCRR), with respect to control of communicable diseases.

 

The lists of reportable diseases in the Health Code and Sanitary Code are periodically modified in response to emerging infections and changing priorities for disease surveillance and control.

 

In addition to reportable disease surveillance, the Department has successfully implemented several different and complementary syndromic surveillance systems to improve outbreak detection capacity as well as provide situational awareness of a wide variety of public health conditions, both routinely and during emergencies.

Since implementation of the Article 13 requirement that clinical laboratories report electronically (approved by the Board in 2006), the Department has greatly enhanced its capacity for receiving more complete and timely reports on notifiable diseases to monitor disease trends and conduct effective investigations. 

 

To conduct more effective, timely and complete disease surveillance and control, the Department is proposing that the Board of Health amend various provisions of Health Code Articles 11 and 13 as follows: 

 

A.     Amend Health Code § 11.03(a) to update the current list of reportable diseases:

1)     Change reporting of “Severe Acute Respiratory Syndrome” to “severe or novel coronavirus” – also changed in paragraph (1) of subdivision (b)

2)     Delete reporting requirement for Kawasaki syndrome

3)     Delete  requirement to report “viral and aseptic meningitis” from reporting of meningitis

 

B.     Amend Health Code § 11.03(d) to add pharmacy sales of both prescription and over the counter medications as new sources for syndromic surveillance.

 

C.    Amend Health Code §11.03(e) to clarify the authority of the Department to obtain information necessary for public health investigations.

 

D.    Amend Health Code §§11.15 and 11.19 to lower the age for exclusion of children with enteric infections in daycare from less than six years of age to less than five years of age.

 

E.     Amend Health Code § 11.17 to clarify Department authority to order health care providers to  isolate individuals with certain communicable diseases that may pose imminent and significant threats to public health until action can be taken by the Commissioner or designee.

 

F.     Amend Health Code §13.03(a) (1) to add data elements to be included on all laboratory reports.

 

G.    Amend Health Code §13.03(b)(1) to require reporting of results of all TB tests  (negative or positive) of subsequent samples from patients with a prior positive acid fast bacilli (AFB) smear or test for M. tuberculosis complex (e.g., culture or nucleic acid amplification [NAA]).

 

H.    Amend Health Code § 13.03(b)(3) to add to hepatitis C reporting all positive and negative hepatitis C (HCV) nucleic acid tests (NAT) laboratory test results. The Department will require only laboratories that electronically submit through the Electronic Clinical Laboratory Reporting System (ECLRS) to report negative HCV NAT laboratory test results through ECLRS. Healthcare providers will not be required to report these results.

 

I.       Amend Health Code § 13.03(b)(3) to require reporting of all hepatitis B virus (HBV) test results (positive, negative and indeterminate) for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs), both qualitative and quantitative, for children ages 168 days to 1,825 days (six months of age up to the fifth birthday). The Department will require only laboratories that electronically submit through the Electronic Clinical Laboratory Reporting System (ECLRS) to report negative HBV laboratory test results through ECLRS. Healthcare providers will not be required to report these results.

 

J.      Amend Health Code § 13.05(b)(1) and add a new paragraph (8)to require reporting of results of all subsequent tests on specimens from persons with a prior positive AFB smear or positive test for M. tuberculosis complex by culture or NAA .

 

Reasons for these changes

 

A)    Changes to the reportable disease list in Health Code §11.03.  The Department is requesting the Board to amend Health Code §11.03 (a) and (b) as follows:

 

1)     Change reporting of “Severe Acute Respiratory Syndrome (SARS)” to “severe or novel coronavirus.” The 2003 epidemic of Severe Acute Respiratory Syndrome (SARS) was due to a novel coronavirus that emerged from mainland China and then spread internationally. In response, the Department added SARS to the list of reportable diseases in Health Code §11.03 to monitor for the re-emergence and potential introduction of this virus into New York City. In 2013, a different coronavirus emerged in the Middle East and resulted in several importations into Europe and hospital outbreaks in both the Middle East and Europe. As of February 7, 2014, there have been 182 cases, including 79 deaths worldwide.  The syndrome caused by this novel coronavirus has been named Middle East Respiratory Syndrome or MERS. To enable the Department to monitor for the introduction of SARS-related, MERS-related, and other novel or severe coronaviruses, the Department is requesting the Board to change “SARS” in §11.03(a) to “severe or novel coronavirus”.  Both suspect and confirmed cases of this disease will also be listed in Health Code § 11.03 (b) (1) as being immediately reportable.

 

2)     Delete Kawasaki syndrome.  Kawasaki syndrome is a rare but serious rash illness that most commonly occurs in children less than 5 years of age. The etiologic agent(s) responsible for Kawasaki syndrome remain unknown despite intensive investigations during prior outbreaks, and the disease does not appear to be spread from person to person. From 2002 to 2012, there has only been a median of 20 cases (range 2 to 35 cases) of Kawasaki syndrome reported in New York City per year. There is no public health response to an individual case other than confirming that the case meets clinical criteria. Kawasaki syndrome is not currently listed as reportable in either the State Sanitary Code or the Centers for Disease Control and Prevention (CDC) National Notifiable Disease Surveillance System. As the Health Code § 11.03 (a) requires reporting of suspected or confirmed outbreaks of any disease or condition (defined as 3 or more cases), the Department would still respond to reports of outbreaks of Kawasaki syndrome after it is removed from the list. There is no reason, however, to continue to make individual cases reportable. Therefore, the Department is requesting the Board to remove Kawasaki syndrome from the list of reportable diseases.

 

3)     Delete viral and aseptic meningitis.  Viral meningitis is a clinical syndrome that can be caused by a wide variety of viruses, most of which do not represent a public health concern, especially for single cases.  Aseptic meningitis is when a patient has the clinical syndrome of meningitis, but the laboratory identifies no microorganisms. Most cases of aseptic meningitis are due to viruses.  Arboviral diseases, including arboviral meningitis, are currently listed and reportable separately in Health Code § 11.03 (a) and will remain reportable given the need to monitor for diseases like West Nile virus to ensure prompt detection and control of mosquito borne viruses in New York City. There is no public health response to an individual case for most other causes of viral or aseptic meningitis. For many, the specific etiologic agent remains unknown once more common causes of bacterial or viral meningitis are ruled out by laboratory testing. Neither viral nor aseptic meningitis are currently listed in the CDC’s National Notifiable Disease Surveillance System. The New York State Department of Health has also indicated they intend to request that the State Public Health and Health Planning Council remove this disease from the State Sanitary Code at some time in the future.  However, even if deleted from the Health Code list, until the disease is deleted from the State Sanitary Code, it will remain reportable in New York City.  Lastly, as Health Code §11.03(a) requires reporting of suspected or confirmed outbreaks of any disease or condition (defined as 3 or more cases), the Department would still respond to clusters of viral or aseptic meningitis even after this disease is removed from the list. Therefore, the Department is requesting the Board to remove viral and aseptic meningitis from the list of reportable diseases.

 

B)    Amend Health Code §11.03 (d) adding pharmaceutical sales to the types of data that may be collected in conducting syndromic surveillance.  In 2008, the Board adopted Health Code 11.03(d), authorizing the Department to collect and monitor certain types of de-identified electronic health care data (e.g., emergency department and clinic visits) to ascertain the existence of and monitor the progress of an outbreak. This type of surveillance, known commonly as “syndromic surveillance,” relies on a wide array of electronic data sources and analytical techniques. Emergency department visit logs and over-the-counter pharmacy sales are examples of health encounter data sources that are routinely collected, available in electronic format, and able to be transmitted in a timely manner for public health monitoring. The Department has been using syndromic surveillance in various formats for the past 12 years as a complement to traditional notifiable disease surveillance to monitor for public health conditions, including seasonal surveillance for influenza-like illness, gastroenteritis, and injuries and mental health issues during and after emergencies (e.g., Hurricane Sandy in 2012).

 

Since 2002, the Department has received data on pharmaceutical sales on a voluntary basis from a large retail chain in New York City. In 2013, a second pharmacy chain was added to the Department’s system, again on a voluntary basis. The Department recognizes the additional value that pharmacy sales data provide to the other syndromic data sources currently listed in Health Code § 11.03(d). Pharmacies may be the first and only contact with the health care system for individuals with early or mild symptoms of disease, and pharmaceutical sales data have demonstrated usefulness in outbreak detection.  One example was a marked increase in sales of over-the-counter antidiarrheal medication that was retrospectively recognized as one of the first indicators of a large outbreak of cryptosporidiosis in Milwaukee in 1993 due to contamination of the municipal water supply.[1] In August 2003, the Department used syndromic pharmacy data to detect an increase in diarrheal illness associated with a citywide power outage.[2]

 

Accordingly, the Department is proposing that the Board add retail pharmacies to the list of facilities in Health Code § 11.03(d) from which reports will be required and to list both over-the-counter and prescription medications as data elements that will be requested. Such reports must be made electronically and in a form, manner, and frequency as specified by the Department. The data collected will not include any personal identifiers.  Specific variables that will be requested from pharmacies include, but may not be limited to, the following:  date of sale, product name, National Drug Code, store address/zip code, store ID, quantity/size, birth year of purchaser (prescription drug only), promotion item and Universal Product Code (over the counter medications only). Pharmacies not equipped to maintain sales data electronically will be exempted from this requirement. It should be noted that Health Code §71.09 currently makes pharmacies’ and other entities’ records subject to inspection by the Department in connection with public health investigations and provides that all information obtained from such records is to be kept confidential by the Department.

 

C)    Amend Health Code §11.03(e) to clarify the Department’s authority to obtain medical information for public health investigations.  Currently, this provision authorizes the Department to obtain additional information concerning any report made by required reporters listed in Health Code §11.05(a) or other individuals required to submit reports in accordance with other applicable law. However, this limits the Department’s authority to obtain information necessary for public health investigations when information about a public health problem originates not with a required reporter of a case or condition, but with other individuals or entities.  In dangerous dog investigations, for example, the health care provider treating the bite victim is required to report the bite pursuant to Health Code §11.03(a) and (e). However, other sources may also report on the bites, such as the person bitten, the owner of the dog, a police officer, a bystander, or local media.  In the course of such an investigation, the Department may learn about other bites inflicted by a particular dog that were not reported by a treating health care provider.  Medical information about the other bite victim’s injuries is also vital to such an investigation. As currently drafted, §11.03(e) could limit the ability of the Department to obtain necessary medical information regardless of whether the case was reported in accordance with §11.03(a). The Department is proposing that the Board amend this provision to clarify its authority to obtain necessary medical information for public health investigations. Although New York City Charter §555 (b) authorizes the Commissioner to issue subpoenas to compel production of witnesses, records, and other documents in any proceeding before the Commissioner, there are so many reported diseases and conditions being investigated at any one time, that requiring subpoenas to be issued is unnecessarily cumbersome. It should also be noted that HIPAA authorizes disclosure of medical information for public health purposes to public health agencies, such as the Department, without patient consent.  In most reportable disease and condition investigations, it is important to be able to investigate and intervene appropriately, based on the best available information, as quickly as possible to prevent further transmission of a communicable disease or injuries from poisonings or other conditions the Department has the duty to investigate.   

 

Another reason to amend this provision is the emergence of organizations that manage the exchange of health information in a defined geographic area for outpatient clinics, provider offices, hospitals, laboratories, and other healthcare entities, currently referred to as regional health information organizations (RHIOs) or Qualified Entities (QEs). With the increasing use of electronic health records and health information exchanges, the Department recognizes health information exchange organizations as potential sources of information necessary for investigations of reportable diseases and conditions listed in Health Code §11.03.  Accordingly, the Department is requesting the Board to add a requirement to §11.03(e) that affords the Department access to electronically stored patient health information by entities such as health information exchange organizations for any confirmed or suspected cases, contacts, or carriers of reportable diseases that is necessary for the Department to conduct its surveillance and epidemiologic investigations, including in response to suspected or confirmed outbreaks. 

 

D)    Amend Health Code §§11.15 and 11.19 to change the age of exclusion for children with enteric infections in daycare and pre-kindergarten from under six years of age to under five years of age. Health Code §11.15 currently requires exclusion of a child under the age of six or staff member who has contact with children under the age of six in a school, day care facility, camp, or other congregate care setting who has been diagnosed with one of the following gastrointestinal illnesses: amebiasis, Campylobacteriosis, cholera, Cryptosporidiosis, E. coli O15:H7 or other Shiga toxin producing Escherichia coli (STEC) infections, Giardiasis, Hepatitis A, Paratyphoid fever, Salmonellosis (other than typhoid), Shigellosis, Typhoid fever, and Yersiniosis.

 

The Department is proposing that the Board lower the age criteria from under six to under five years, so that control efforts are focused on the children at highest risk in daycare or pre-kindergarten settings. Outbreaks or person-to-person spread are much less common among children who are toilet trained and no longer require diaper care.  Excluding children from kindergarten requires children to miss educational services and a parent or caregiver to stay home from work creating a significant burden for families.  Changing the threshold from under 6 years to under 5 years will allow the Department to focus enforcement efforts in children attending daycare or pre-kindergarten settings, and not children attending kindergarten or elementary school where the risk of disease transmission is less.  For the same reasons, the Department is proposing that the change in excluding children only under age five also be made applicable to cases of paratyphoid and typhoid fever in §11.19.

 

E)    Amend Health Code § 11.17 to clarify the Department’s authority to order the isolation of persons with communicable diseases that may pose an imminent and significant threat to public health. Subdivision (a) of Health Code §11.17 (Control measures; duty to isolate; and isolation, quarantine and examination orders) requires that suspected or confirmed cases and carriers of specific contagious infectious diseases and “any other contagious disease that in the opinion of the Commissioner may pose an imminent and significant threat to the public health … shall be isolated in a manner consistent with recognized infection control principles and isolation procedures in accordance with State Department of Health regulations or guidelines.” The Health Code provision does not explicitly impose a duty upon the physicians attending these cases or carriers to isolate them until the Commissioner or designee takes further action. The proposed amendment clarifies that physicians attending to these patients are required to isolate them.    

 

A similar provision in the State Sanitary Code § 2.27 imposes a duty upon attending physicians to isolate persons with “highly communicable diseases,” pending public health action. It refers to Sanitary Code § 2.1 for a definition of “highly communicable diseases.”  However, Sanitary Code § 2.1 lists only certain reportable diseases and does not indicate that there may be other emergent diseases of public health concern that are not listed. The proposed amendment to Health Code § 11.17(a) will clarify that physicians attending patients with diseases listed in Health Code § 11.17, as well as those with emergent diseases that are not currently reportable, are required to isolate them pending further action by the Department.

 

 

F)     Amend Health Code §13.03(a) to require additional data elements to be submitted with electronic laboratory reports of notifiable diseases and conditions. Electronic laboratory reporting has greatly improved the timeliness and completeness of reportable disease surveillance. As more health care information is now available with enhancements and improved linkages in electronic health record systems, it is possible to obtain more complete information on the case-patient and the health care provider who requested testing to facilitate case investigations. The Department is requesting that the Board add the following data elements to the list of information that should accompany all electronic laboratory reports, if known, in Health Code §13.03: 

 

Patient email

Patient mobile phone number

Provider email

Provider fax number

Provider mobile phone number

Provider National Provider Identification (NPI) number

Facility National Provider Identification (NPI) number

 

In addition, paragraph (1) of Health Code §13.03(a) currently requires the pregnancy status to be indicated if known and if clinically relevant (e.g., for hepatitis B and syphilis).  Although the laboratory may not know the patient’s pregnancy status based on information provided by the requesting health care provider, the laboratory would know that a pre-natal panel of laboratory tests was ordered. Therefore, the Department is proposing to amend this provision to require information about pregnancy either when pregnancy status is known and indicated or when pregnancy is probable (e.g., a pre-natal panel is ordered).

  

These additional data elements will enhance the Department’s disease surveillance efforts by improving its ability to contact patients and/or providers to obtain additional information required for a case investigation.

 

G)    Amend Health Code §13.03(b)(1) and §13.05 to require reporting of all tuberculosis test results of subsequent samples for patients with either an initial positive acid fast bacilli (AFB) smear or positive culture or other test for M. tuberculosis complex. The Department is proposing that the Board amend Health Code §13.03(b)(1) to require the reporting of all subsequent test results for a patient with a previous positive test result for AFB smear, nucleic acid amplification (NAA), mycobacterial culture, or other test for M. tuberculosis complex. Currently negative results are only reported when results are from samples with an AFB positive smear. This amendment will enable the Department to more quickly rule out a suspected diagnosis of TB and discontinue unnecessary treatment and to better monitor treatment.

 

Cases and suspect cases of TB disease residing in New York City are managed by the Department, sometimes in partnership with private providers. Currently, laboratories are required to report to DOHMH all results from biological samples found positive for AFB, cultures and NAA tests positive for M. tuberculosis complex, drug susceptibility tests performed on M. tuberculosis complex cultures, pathology findings indicative of TB, and any culture or NAA result associated with an AFB-positive smear sample even if negative. Current reporting is not, however, timely enough to identify persons who were suspected as having TB, started treatment, and later found not to have TB disease, nor is it adequate enough to track TB patients ’ response to treatment.

 

Test results on initial samples collected from patients are used to diagnose TB disease and determine infectiousness. Test results from subsequent samples collected after an initial positive sample are used to monitor a patient’s response to treatment. Receiving timely test results, either positive or negative, is critical for these purposes.

 

Current required test results are reported electronically or via fax to the Department when they become available. To obtain negative test results that are not currently reportable, Department staff must visit hospitals to perform chart reviews and visit or call providers and laboratories. Getting a negative result can take multiple attempts over months. Patients suspected of TB are placed on treatment until TB diagnosis is ruled out, which is generally based on laboratory test results. Reducing the time to obtain negative test results can reduce the time the patient is on unnecessary treatment. More importantly, negative results are critical for monitoring patients on treatment. In general, patients on appropriate treatment are expected to have negative culture results within 60 days of treatment. Extending treatment may be necessary if patients do not have a documented negative culture conversion. Having negative results automatically reported to the Department will decrease the time it takes for patients to be deemed non-infectious and will assist the Department in determining the optimal treatment length for TB patients.

 

H)    Amend Health code §13.03(b)(3) to require reporting of negative hepatitis C virus (HCV) nucleic acid tests (NAT) (electronic laboratory reporting only).  The Department is proposing that the Board amend Health Code §13.03(b)(3) to require reporting of all HCV NAT results. This provision currently specifies only that HCV (and other hepatitis) reports made by clinical laboratories be accompanied by results of alanine aminotransferase testing (ALT).  The addition of required reporting of NAT results will support the Department’s 2013 plan[3] to reduce illness and death from HCV. One component of this plan involves strengthening the Department’s capacity to manage and utilize data for evidence-based policies and practice. By receiving reports of both positive and negative test results for HCV NAT, the Department will be able to estimate the number of persons tested, the burden of chronic HCV infection in New York City, the number of persons treated for and cured of chronic HCV infection, and monitor changes over time, similar to what is currently authorized for human immunodeficiency virus (HIV) infection.

 

As many as 146,500 New York City residents may have chronic HCV. The disease is most prevalent in New York City neighborhoods with high poverty. Most persons living with HCV have few symptoms of illness until 10 to 30 years after initial infection, when life-threatening health complications, including cirrhosis and liver cancer, can develop. The annual number of deaths associated with HCV has been increasing yearly and, since 2007, has exceeded deaths associated with HIV in the United States. Highly effective HCV antiviral treatments have recently been approved, and more are expected in the coming years, making it likely that liver failure, cancer, and death from HCV can be averted in the future.

 

Antibody screening tests for HCV are recommended for all persons born between 1945 and 1965 and for patients with risk factors, including any history of injection drug use or receipt of a blood transfusion before 1992. However, 15-25% of patients who test HCV antibody positive have no detectable HCV nucleic acid in their blood, indicating that they do not have HCV infection. This is usually because they either resolved a prior HCV infection or had a false-positive HCV antibody test. Therefore, it is recommended that all patients with a positive HCV antibody test undergo HCV NAT testing to determine infection status.

 

The Department found that, from 2009 to 2012, 27% of patients with a positive HCV antibody never received an HCV NAT test, while an additional 9% only received NAT testing after the Department sent a reminder to the clinician that NAT testing is recommended.

 

Currently, both the Sanitary Code and Health Code § 11.03 mandate reporting by health care providers and others of persons who are cases and carriers of HCV. Laboratories must report positive HCV antibody screening tests and all positive confirmatory assays, e.g., recombinant immunoblot assay (RIBA) or NAT, that result from laboratory analysis of specimens in accordance with the “Laboratory Reporting of Communicable Diseases, 2010” guidance issued by the Department and the New York State Department of Health.  With nearly 10,000 new cases of HCV reported each year, the Department does not currently have sufficient staff resources to conduct individual case investigations by chart review and patient and provider interviews to determine infection and treatment status.  If the Department received results of both positive and negative tests for HCV NAT, this would provide more useful information for tracking the HCV epidemic in New York City. First, it would be possible to accurately classify patients as chronically infected by determining which antibody-positive patients are infected (NAT positive) versus not infected (NAT negative). Second, it would be possible to evaluate HCV testing patterns and focus outreach efforts toward providers who are not following HCV NAT testing recommendations. Third, by making all HCV NAT results reportable, the Department would also be able to estimate the proportion of patients who are receiving care for their diagnosis. For example, patients with only an antibody test but no NAT test would presumably not be in care. Patients who are NAT positive, but become NAT negative over time, would be presumed to be on treatment and, if the negative NAT tests are sustained, to be cured. The Department would be able to use these data to target interventions to those neighborhoods that have persistently higher levels of HCV viral loads based on HCV NAT results. These data could also be used to identify and prioritize linkage to care for persons who have been diagnosed with chronic HCV but have been lost to medical follow-up. Finally, these data will help the Department evaluate and, as needed, enhance our policies and programs on HCV prevention and control.

 

Therefore, the Department is requesting the Board to include a requirement for laboratories to report negative HCV NAT test results through the Department’s electronic reporting mechanism set forth in Health Code § 13.03(c).

 

I)       Amend Health code §13.03(b)(3) to require reporting of negative hepatitis B virus (HBV) test results for children for children ages 168 days to 1,825 days (six months of age up to the fifth birthday).The addition of required reporting of HBsAg (hepatitis B surface antigen) and anti-HBs (hepatitis B surface antibody) test results for children ages six months to five years of age will support the Department’s efforts to help prevent perinatal HBV among children born to HBV-infected mothers and to conduct surveillance for this nationally notifiable disease. Children born to HBV-infected mothers are at high risk of acquiring this infection. If infected, 90% will develop chronic hepatitis infection, placing them at risk for cirrhosis and hepatic carcinoma at an early age.

 

Each year, the Department case manages approximately 1,800 babies born to HBV positive pregnant women in New York City. Through individual patient education and case management, the Department helps to ensure that the newborns receive HBV immune globulin and HBV vaccine within 12 hours of birth and two more doses of HBV vaccine by six months of age to prevent HBV infection. These high-risk children should have post-vaccination serology testing performed at nine months of age to assess if they are infected, susceptible, or immune. Interpretation requires the test results for both HBsAg and anti-HBs. Children who are found to be infected have to be referred to a specialist for evaluation and treatment.  Children who are found susceptible after the first immunization series have to immediately begin a second three dose series of HBV vaccination.

 

Currently, the Department contacts the pediatric provider who administered the HBV vaccinations to provide reminders and to obtain post-vaccination serology testing results. This activity consumes approximately 25% of staff time. In addition, the Department is frequently unable to obtain all test results due to not being able to locate the family or the pediatric provider. The Department does not obtain test results for approximately 40% of the 1,800 babies managed annually. By requiring reporting of all test results for HBsAg and anti-HBs for children ages six months to five years, the Department will receive post-vaccination serology test results more efficiently and completely. The Department will be better able to manage cases lost to follow-up either by the Department or by other health jurisdictions, which may have cases that have moved to New York City.




[1]Mac Kenzie WR, Hoxie NJ, Proctor ME, Gradus MS, Blair KA, Peterson DE, et al. A massive outbreak in Milwaukee of cryptosporidium infection transmitted through the public water supply. NEJM 1994; 331(3): 161-167.

 

[2]Marx MA, Rodriguez CV, Greenko J, et al. Diarrheal illness detected through syndromic surveillance after a massive power outage: New York City, August 2003. Am J Public Health. 2006;96(3):547-53.

[3] Hepatitis C in New York City: State of the Epidemic and Action Plan.  Available at http://www.nyc.gov/html/doh/downloads/pdf/cd/hepC-action-plan.pdf

 

Subject: 

Proposed resolution regarding reportable diseases and conditions, and laboratories (Articles 11 and 13 of the New York City Health Code)

Location: 
New York City Department of Health and Mental Hygiene, Gotham Center
42-09 28th Street 14th Floor, Room 14-43
Queens, NY 11101-4132
Contact: 

Svetlana Burdeynik at (347) 396-6078 or resolutioncomments@health.nyc.gov
New York City Department of Health and Mental Hygiene
Gotham Center, 42-09 28th Street, CN 31
Long Island City, NY 11101-4132

Download Copy of Proposed Rule (.pdf): 

Adopted Rules: Closed to Comments

Adopted Rules Content: 

Statement of Basis and Purpose of Rule

 

Statutory Authority

This amendment to the New York City Health Code (“Health Code”) is made pursuant to Sections 556, 558 and 1043 of the New York City Charter (“Charter”).  Section 556 of the Charter grants the New York City Department of Health and Mental Hygiene (“Department”) jurisdiction to regulate all matters affecting health in the City of New York.  Specifically, Section 556 (c)(11) of the Charter authorizes the Department to regulate all aspects of ionizing radiation within the five boroughs of New York City. Sections 558 (b) and (c) of the Charter empower the Board of Health to amend the Health Code and to include in the Health Code all matters to which the Department’s authority extends.  Section 1043 of the Charter grants rule-making powers to the Department.

 

Section 228 of the New York State Public Health Law provides that local enactments like section 175.07 of the Health Code must be consistent with the requirements of the New York State Sanitary Code, as codified at Chapter I of Title 10 of the Codes, Regulations and Rules of New York State.  In order to be consistent with recent State Sanitary Code amendments involving updated quality assurance requirements for external beam and brachytherapy radiation treatment, the Board of Health is effecting commensurate changes to the corresponding requirements in the Health Code. 

 

Background

The Department, through its Office of Radiological Health (“ORH”), regulates radioactive material for medical, research and academic purposes within the five boroughs of New York City.

ORH regulations for radiation machines and radioactive materials are contained in Article 175 of the Health Code.  ORH registers and inspects radiation machines, and licenses and inspects radioactive materials facilities for compliance with Article 175 for the protection of the health and safety of patients, radiation program employees and the general public.

 

There are about 6500 registered facilities possessing radiation machines and 375 licensed sites in New York City possessing radioactive material for medical, academic and research purposes. Of the registered facilities, approximately 6440 are registered diagnostic X-ray facilities and 60 are therapeutic X-ray facilities possessing certified registrations.

The State Sanitary Code was recently amended to reflect updated quality assurance requirements for external beam and brachytherapy radiation treatment (see, 10 NYCRR §16.24(a)). In order to maintain consistency, the Board of Health is making commensurate changes to the corresponding requirements in §175.07(c) of Article 175 of the Health Code.

 

Rule Elements and Goals

The Board of Health is repealing current subdivision (c) of §175.07 and replacing it with a new subdivision (c) that includes updated quality assurance standards for radiation materials licensees or radiation equipment registrants who are authorized to administer external beam therapy or brachytherapy to humans.  The new subdivision includes quality standards appropriate for newer, more complex radiation therapy treatment systems and also requires additional verification of radiation set-up equipment and treatment plans prior to administering radiation treatments to patients.  New subdivision (c) also requires quality assurance programs to cover data communication/transfer between component systems of planning and treatment delivery systems to ensure complete, uncorrupted data transfer.  Additionally, the new subdivision requires licensees and registrants to credential individuals involved in quality assurance testing, treatment planning, and radiation treatment of patients.  Finally, new subdivision (c) requires licensees and registrants to be accredited in radiation oncology by the American College of Radiology or the American College of Radiation Oncology, or another equivalent accrediting organization, within 18 months of the publication of this rule.

 

Effective Date: 
Mon, 04/21/2014

Adopted Rules: Closed to Comments

Adopted Rules Content: 

Statement of Basis and Purpose

Background

As the U.S. Food and Drug Administration (FDA) has warned, “There is no such thing as a safe tan.”[ii]  Tans are caused by the skin’s reaction to ultraviolet (UV) radiation and any exposure to UV rays can lead to skin cancer and other diseases.  Ultraviolet radiation devices, or “indoor tanning devices,” are devices available at many facilities for members of the public to use to tan.  In the State of New York, they generally are regulated by the New York State Department of Health under Article 35-A of the Public Health Law. Pursuant to State Department of Health regulations, local health departments, however, may request and be given authority by the State to regulate their operation locally.[iii]  The Department has made such a request to regulate indoor tanning devices in the City of New York.

Tanning and Cancer

Users of indoor tanning devices are at risk for multiple adverse health consequences. The World Health Organization’s International Agency for Research on Cancer (IARC) classifies indoor tanning devices, which emit UV radiation, as “Group 1”[iv] carcinogens because there is “sufficient evidence” that their use causes “carcinogenicity in humans.”[v]  The IARC based its classification on evidence showing associations between indoor tanning and skin cancer (both melanoma and carcinoma) and eye cancer (ocular cancer).[vi]  It observed that the risk of melanoma is “increased by 75% when the use of tanning devices starts before 30 years of age.”[vii] The U.S. Department of Health and Human Services’ National Toxicology Program similarly classifies tanning devices as, “known to be human carcinogens.”[viii] Skin cancer is the most common form of cancer in the United States, and annually costs the country an estimated $1.7 billion in medical costs and results in $3.8 billion in lost productivity.[ix]In New York State, approximately 2,000 men and 1,500 women are diagnosed with melanoma each year (averaged over 2005 through 2009)[x].

Other Risks of Tanning

In addition to increasing the risk of certain cancers, the use of indoor tanning devices can also cause ocular damage, premature aging of the skin, immune system repression and exacerbation of pre-existing medical conditions.[xi]  Indoor tanners may also experience serious burns requiring emergency medical treatment.  In the U.S., according to the FDA, an average of 1,800 emergency department visits are caused by UV tanning devices every year, and the number of burn cases treated by doctors or urgent care clinics is probably significantly higher.[xii] A study of adolescent indoor tanning practices between 1998 and 2004 found that over 60% of indoor tanners between the ages of 16 and 18 years old reported experiencing erythema, or burns, after indoor tanning sessions.[xiii] 

Frequency and Risk

The earlier a person begins indoor tanning and the more frequently they tan, the greater the risk is that they will develop skin cancer. Research has demonstrated a strong “dose response” relationship between melanoma risk and the total hours of indoor tanning over a lifetime.  This means the risk of cancer from indoor tanning is cumulative and increases with every use.[xiv]  Early and frequent use of indoor tanning devices, however, is not uncommon. While minors under the age 17 are legally prohibited from tanning in the state of New York, (Chapter 105, Laws of 2012), the use of tanning among older adolescents and young adults is prevalent and frequent.  The most recent national Youth Risk Behavior Survey (YRBS, 2011) found that approximately 40% of non-Hispanic white females ages 17-18 have used a tanning device in the last year and that approximately 24-30% of that group reporting tanning at least 10 times in the last 12 months.[xv]  A similar study of adults (the National Health Interview Survey, 2010) found that approximately 30% of non-Hispanic white females between the ages of 18-25 reported indoor tanning at least once annually.[xvi] Among adults who tan, approximately 50 percent reported using tanning devices more than 10 times in a year, with women reporting that they use them an average of 20 times per year.[xvii] Among youths ages 16 to 18 who tan indoors, the average number of visits is approximately nine times per year.[xviii] Multiple studies have shown that the repeated use of indoor tanning may result in behavioral consequences, including physical and psychological addiction to tanning.  In other words, the more people tan, the more they feel compelled to tan, increasing their health risks.[xix] 

Efforts to Reduce Tanning

Despite the large body of evidence documenting the health risks associated with indoor tanning, indoor tanning rates have continued to increase.[xx]

A study of university-age students found that the students’ general understanding of the health risks associated with indoor tanning did not influence their decision to indoor tan.[xxi]  A study by the FDA of its own warning material found that a modified warning message “may more effectively convey [the] risks [of indoor tanning] than the current labeling requirements,” which mandate that labels state factual information about the dangers of indoor tanning devices.

Rule Elements and Goals

The Department would, if approved, assume regulatory authority of tanning facilities within New York City from the New York State Department of Health.  Consistent with State law, these rules are being made as part of that oversight.

These rules are intended to reduce the risk of tanning-related health effects among tanning facility patrons by increasing the awareness of the risks of indoor tanning and establishing the safer and more sanitary operation of tanning facilities.  These rules: 1) provide definitions and requirements for permit issuance, inspection and operation of tanning facilities, and 2) would enable the Department to apply effective strategies used successfully to change risky behavior.

These rules shall take effect six (6) months after their publication in the City Record.

 

 


 

[i] New York Codes, Rules and Regulations, (NYCRR), Title 10, Part 72, Subpart 72-1.  Electronic version: http://www.health.ny.gov/regulations/nycrr/title_10/part_72/subpart_72-1...

[iii]New York Codes, Rules and Regulations, (NYCRR), Title 10, Part 72, Subpart 72-1. 

[iv]Group 1 is the IARC’s highest cancer risk category and includes other well-established carcinogens like asbestos, arsenic and tobacco smoke. IARC, Agents Classified by the IARC Monographs, Volume 1-104: http://monographs.iarc.fr/ENG/Classification/ClassificationsGroupOrder.pdf..

[vi] IARC Monographs on the Evaluations of Carcinogenic Risks to Humans, Volume 100, Part D: Radiation. WHO Press, 2009. See also, Special Report: Policy, A Review of Human Carcinogens – Part D: Radiation. The Lancet ,August, 2009; and Zhang et al., Use of Tanning Beds and Incidence of Skin Cancer, Journal of Clinical Oncology, May 10, 2012.

[vii] IARC, 2009;  See also, Dennis K. Woo and Melody J. Eide. Tanning Beds, Skin Cancer, and Vitamin D: An Examination of the Scientific Evidence and Public Health Implications, Dermatologic Therapy, 2010.

[viii] U.S. Department of Health and Human Services, Public Health Services, National Toxicology Program, Report on Carcinogens, 12th ed.: Exposure to Sunlamps or Sunbeds (2011).

[ix] CDC Morbidity and Mortality Weekly Report, Use of Indoor Tanning Devices by Adults – United States, 2010. Volume 61, Number 18.  May 11, 2012; see also Bickers et al., The Burden of Skin Disease. Journal of American Academy of Dermatology. 2006.

[x]New York State Department of Health, New York State Cancer Registry.  Skin Cancer in New York State, Fifth Annual Report to the Governor of New York, the Temporary President of the Senate, and Speaker of the Assembly, 2012.  Report available at: http://www.health.ny.gov/statistics/diseases/cancer/skin/report/docs/201....

[xi] James M. Spencer and Rex A. Amonette. Indoor Tanning: Risks, Benefits, and Future Trends, Journal of the American Academy of Dermatology (1995).

[xii] National Electronic Injury Surveillance System, CDC. Reported on FDA website: http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsa...

[xiii] Cokkinides et al. Indoor Tanning among Adolescents in the US, 1998 to 2004. Cancer, January 2009.

[xiv] Lazovich et al.. Indoor tanning and risk of melanoma: a case-control study in a highly exposed population.  Cancer Epidemiol Biomakers Prev. June, 2010.

[xv] Guy et al.  Indoor Tanning Among Young Non-Hispanic White Females.  Journal of the American Medical Association, Internal Medicine, Letters. Published online August 19, 2013; See also, Mayer et al..  Adolescents’ Use of Indoor Tanning: A Large-Scale Evaluation of Psychosocial, Environment, and Policy-Level Correlates.  American Journal of Public Health. May, 2011.  See also Cokkinides et al.. Use of indoor Tanning Sunlamps by US Youths, Ages 11-18 Years, and by their Parent of Guardian Caregivers: Prevalence and Correlates.  Pediatrics. 2002.  American Journal of Public Health. May, 2011.

[xvi] Guy et al., 2013; See also reference ix, CDC MMWR, 2012.

[xvii] See reference ix, CDC MMWR, 2012.

[xviii] See reference xiii, Cokkinides et al., 2009.

[xix] David E. Fisher and William D. James.  Indoor Tanning – Science, Behavior, and Policy.  New England Journal of Medicine. September 2010; see also, Catherine E. Mosher and Sharon Danoff-Burg.  Addiction to Indoor Tanning: Relation to Anxiety, Depression, and Substance Use. Arch Dermatol, April, 2010.

[xx] See reference vii Woo et al.; See also Purdue et al.. Recent Trends in incidence of cutaneous melanoma among U.S. Caucasian young adults.  Journal of Investigative Dermatology. December. 2008: 128(12), 2905-2908

[xxi] Knight et al.. Awareness of the Risks of Tanning lamps Does Not Influence Behavior Among College Students.  Arch Dermatol. October, 2002.

Effective Date: 
Tue, 06/17/2014

Adopted Rules: Closed to Comments

Adopted Rules Content: 

STATEMENT OF BASIS AND PURPOSE

 

ORH regulations for radiation machines and radioactive materials are contained in Article 175 of the Health Code.  ORH registers and inspects radiation machines, and licenses and inspects radioactive materials facilities for compliance with Article 175 for the protection of the health and safety of patients, radiation program employees and the general public.

 

There are about 6500 registered facilities possessing radiation machines and 375 licensed sites in New York City possessing radioactive material for medical, academic and research purposes. Of the registered facilities, approximately 6440 are registered diagnostic X-ray facilities and 60 are therapeutic X-ray facilities possessing certified registrations.

 

I.          Cone Beam Computed Tomography (CBCT)

 

Cone Beam Computed Tomography (CBCT) units are specialty CT x-ray units that produce radiation levels higher than conventional dental intra-oral x-ray units and are utilized for the imaging of the jaw, specific teeth, and the sinus cavity with high resolution. CBCT is useful for imaging and reconstruction of the human anatomy where speed and accurate reconstruction of structures is essential, but low contrast resolution is not essential. CBCT units were introduced into the dental environment in the early 2000s as an advanced imaging technology for dentists.  The dental community has embraced CBCT technology and dental imaging professional organizations have put out position papers on CBCT use in the dental office.

 

CBCT has the potential to generate radiation exposures outside the range of traditional dental x-ray devices and has increased operational complexity that can result in unintended exposures to the public and workers. The graphic below identifies where the CBCT radiographic units fit in the universe of radiographic units that ORH regulates. The scale below presents the range of exposure in terms of milliamperes (mA) values[1] and shows that CBCT units are outside the range found from common dental x-ray devices:

   

 [see pdf for graphic]

 

Another measure of comparison for radiographic units is to compare the typical Entrance Skin Exposure (ESE) or entrance patient dose, which are typically interchangeable for diagnostic x-ray kVps. CBCT manufacturer manuals reviewed indicate that the typical range for CBCT entrance dose is in the range of 2 – 4.4 mGy (about 0.2 – 0.44 rads).  Data tabulated by the regulatory community in the United Kingdom shows that the effective dose for CBCT units are higher than conventional dental x-ray procedures:

Table:  Typical doses from x-ray examinations of the head

Dental Panoramic Exam                        Effective Dose (uSv) =              24   micro Sieverts

CBCT Unit (large Field of View)         Effective Dose (uSv) =     68-1073   micro Sieverts

CT Scan Dental Program                      Effective Dose (uSv) =   534-2100   micro Sieverts

 

 

Currently, there are no standards in Article 175 to regulate CBCTs installed in dental offices. ORH estimates that 90 dental facilities employ CBCT in New York City.  Dental facilities possessing such CBCT units will be required to register with and allow inspection by the Department and will need to develop a quality assurance program, which will be composed of periodic quality control testing and a radiation safety manual to ensure patient and operator safety. The proposed regulations are needed to protect both the members of the public undergoing such CBCT exams and operators of the CBCT units.

 

II.        Operator protective lead garments

 

Protective lead garments are an important radiation safety tool for radiation facility operators and their workers conducting fluoroscopic[2] procedures in order to reduce their occupational radiation exposures.  To assure that these lead protective garments retain their integrity over time, these garments should undergo routine testing by a variety of methods, as indicated in these proposed rules. If defective protective garments are used unknowingly, then their users will be subjected to unnecessary radiation exposures.

 

Currently, there are no standards in Article 175 for the integrity testing of protective lead garments.  These proposed rules will provide a uniform standard for testing lead protective garments for registrants of radiation facilities to help ensure that their workers’ occupational radiation exposures can be minimized. 

 

III.       Medical event reporting

 

The Department seeks to clarify that reporting of a medical event is required not only of radiation materials licensees, but also by radiation equipment registrants.  The internal cross-reference provided in the definition of “medical event” is also being revised.




[1] The quantity of electron flow (current) in the x-ray tube is described in units of milliamperes (mA).  The rate of x-ray production is directly proportional to the x-ray tube current. Higher mA values indicate more electrons are striking the target and therefore producing more x-rays. (Source: http://www.e-radiography.net/radsafety/rad_physics.htm.)

[2] Fluoroscopy is a type of medical imaging that shows a continuous x-ray image on a monitor. It is used to diagnose or treat patients by displaying the movement of a body part or of an instrument or dye (contrast agent) through the body. During a fluoroscopy procedure, an x-ray beam is passed through the body. The image is transmitted to a monitor so that the body part and its motion can be seen in detail.  (Source: http://www.fda.gov/radiation-emittingproducts/radiationemittingproductsa...)

 

Effective Date: 
Tue, 01/21/2014

Adopted Rules: Closed to Comments

Adopted Rules Content: 

 DEPARTMENT OF HEALTH AND MENTAL HYGIENE

Statement of Basis and Purpose

       The Charter provides the Department with jurisdiction over all matters concerning health in the City of New York. The Bureau of Child Care, in the Department’s Division of Environmental Health, enforces Article 47 (Day Care Services) and Article 43 (School-Based Programs for Children Ages Three Through Five) of the Health Code. Article 47 regulates all public and private group day care services for children less than six years of age. Article 43 contains health and safety standards for school-based programs for children ages three through five.  

       The Board is amending Articles 47 and 43 to require that children attending child care services and school-based programs under the Department’s jurisdiction receive annual vaccinations against influenza, and to add immunization against pneumococcal disease to the list of required pre-admission immunizations in these Articles.  Full citations for reports and studies cited in the section on influenza vaccination are listed at the end of this Statement of Basis and Purpose.

 Influenza vaccination

       Influenza causes an estimated 200,000 hospitalizations and an average of 36,000 (range 3,000-49,000) deaths annually in the United States (CDC, 2010). Approximately 20,000 hospitalizations and 30-150 deaths occur in children under 5 years of age each year.  Children typically have the highest attack rates of influenza, which can be as high as 40%, and children serve as a major source of transmission within communities.  Each year, an estimated 15%-42% of preschool children contract influenza, and 38 million school days are missed due to influenza illness (CDC/ National Center for Health Statistics, 1999).

        Influenza strains vary from year to year. The US Food and Drug Administration annually licenses influenza vaccines for administration based on a scientific consensus identifying “virus strains  likely to cause the most illness during the upcoming flu season” (generally October through April in the middle Atlantic states). (USFDA, 2012) Vaccination only protects against the strains specifically included in the approved vaccine. Therefore, immunization is only effective for the year in which it is given, and a different influenza vaccine generally needs to be administered each year. The effectiveness of influenza vaccine varies with the severity of flu season, circulating influenza viruses, vaccine composition, and the age group studied. In children less than 6 years of age, influenza vaccine efficacy, ability to prevent influenza infection, ranged from 59%-82%; effectiveness, a measure of how vaccine performed in real world settings in preventing influenza, ranged from 24%-36%.(T Jefferson, 2005; M Fujieda, 2006; Jefferson, 2008; Hoberman, 2003; Longini I, 2012) Belshe et. al. showed that live attenuated influenza vaccine (LAIV) was 55% more effective than trivalent inactivated vaccine (TIV) in preventing laboratory-confirmed influenza in children 6-59 months old (Belshe, 2007).

        Influenza vaccination has been found to be safe for use in children (Hambridge SJ, 2006; Glanz JM, 2011; France EK, 2004; Bernstein DI, 1982, Skowronski DM 2006). Based on the scientific evidence, the federal Advisory Committee on Immunization Practices – which sets the standard of care for the United States – recommends that everyone 6 months of age and older receive an annual influenza vaccination. Trivalent inactivated vaccine (TIV) is licensed for use in all children >6 months of age, and live attenuated influenza vaccine (LAIV; delivered as a nasal spray) is licensed for use in children >24 months. 

         Vaccinating children produces “herd immunity” in the general population. This means that. vaccinating children against influenza reduces the number of influenza infections in everyone else, regardless of whether they were vaccinated or not (Piedra PA, 2005). Vaccinating younger children may also protect against secondary cases (Reichert, 2001). One study looked at respiratory illness in household contacts of vaccinated and unvaccinated children attending daycare. Among study participants, vaccine efficacy  in preventing  proven influenza infection by measuring protective levels of antibodies was 45% for influenza B and 31% for influenza A (H3N2) during the 1996-97 influenza season.  The greatest effect of vaccination was seen in household contacts 5 to 17 years of age; household contacts of vaccinated children  had a 50% reduction in respiratory illnesses and an 80% reduction in febrile respiratory illness compared to unvaccinated children.  Statistically significant declines in illness were not seen for household contacts of younger children or adults, though the study was limited by small sample size (ES Hurwitz, 2000).  A second paper found a correlation between states with higher influenza immunization coverage among 19-35 month-olds and reduced influenza and pneumonia hospitalizations rates among adults over the age of 65 (based on claims records for Medicare eligible P&I hospitalizations) (SA Cohen, 2011).  This analysis was conducted before routine pediatric influenza vaccination; summary coverage estimates rose from 8.3% in 2002-2003 to 33.5% in 2005-2006.

         Despite active promotion of influenza vaccination for children, coverage rates have risen slowly in New York City. As of March 26, 2013, 61.0% of children ages 6 months through 59 months received at least one dose of influenza vaccine compared to 56.7% at the same time in 2012.  This still leaves nearly 4 out of every 10 young children unprotected. Furthermore, young children are at high risk of influenza-related complications and hospitalization, making this vulnerable group especially important to protect.[1]

        Finally, while child day care permittees and persons in charge of schools are required by Health Code §§47.27(e) and 43.19(e) to report to the Department within 24 hours any instance of a vaccine preventable disease, the Department does not expect individual cases of seasonal influenza to be reported. Reports by schools and day care facilities will, however, continue to be required as provided in Health Code §11.03 (a) and (b) of cases of a novel strain of influenza with pandemic potential, the influenza related death of a child under 18 years of age, or an outbreak of influenza.

 Pneumococcal disease immunization

        The Board is also amending Health Code §§43.17(a)(2) and 47.25(a)(2) to add “pneumococcal disease” to the list of required immunizations. This immunization, which is required by Public Health Law §2164(2), was inadvertently omitted from these sections. 

 References:

Belshe, R, Edwards K, Vesikari T, et. al. Live attenuated versus inactivated influenza vaccine in infants and young children. NEJM. 2007;356(7):685-696.

Bernstein DI, Zahradnik JM, DeAngelis CJ, et. al. Clinical reactions and serologic responses after vaccination with whole-virus or split-virus influenza vaccines in children aged 6 to 36 months. Pediatrics. 1982;69:404-408.

CDC. Estimates of Deaths Associated with Seasonal Influenza - United States, 1976-2007. MMWR. 2010;59(33):1057-1062.

CDC/ National Center for Health Statistics. Current estimates from the National Health Interview Survey, 1999.  Series 10, No 200.

Cohen G, Nettleman M. Economic impact of vaccination in preschool children. Pediatrics. 2000;106(5):972-976.

France EK, Glanz JM, Xu S, et. al. Safety of the trivalent inactivated influenza vaccine among children: a population-based study. Arch Pediatr Adolesc Med. 2004;158(11):1031-1036.

Fujieda M, Maeda A, Kondo K, et. al. Inactivated influenza vaccine effectveness in children under 6 years of age during the 2002-2003 season. Vaccine. 2006;27(7):957-963.

Glanz JM, Newcomer SR, Hambidge SJ, et. al. Safety of trivalent inactivated vaccine in children aged 24 to 59 months in vaccine safety datalink. Arch Pediatr Adolesc Med. 2011;165(8):749-755.

Hambidge SJ, Glanz JM, France EK, et. al. Safety of trivalent inactivated influenza vaccine in children 6 to 23 months old. JAMA. 2006;296(16):1990-1997.

Hoberman A, Greenberg D, Paradise J, et. al.  Effectiveness of inactivated influenza vaccine in preventing acute otitis media in young children. 2003;290(12):1608-1616.

Hurwitz E, Haber M, Chang A, et. al. Effectiveness of influenza vaccination of day care children in reducing influenza-related morbidity among household contacts. JAMA. 2000;284(13):1677-1682.

Jefferson T, Rivetti A, Harnden A, et. al. Vaccines for preventing influenza in healthy children. Cochrane Database Syst Rev. 2008;(2):CD004879.

Jefferson T, Smith S, Harnden A, et. al. Assessment of the fficacy and effectiveness of influenza vaccines in healthy children: systematic review. Lancet. 2005;365:773-780.

Longini I. A theoretic framework to consider the effect of immunizing schoolchildren against influenza: implications for research. Pediatrics. 2012;129(S2):S62-S67.

Piedra PA, Manjusha GJ, Kozinetz CA, et. al. Herd immunity in adults against influenza-related illnesses with use of the trivalent-live attenuated influenza vaccine (CAIV-T) in children. Vaccine. 2005;23(13):1540-1548.

Reichert TA, Sugaya N, Fedson DS, et. al. The Japanese experience with vaccinating schoolchildren against influenza. NEJM. 2001;344(12):889-896.

Skowronski DM, Jacobsen K, Daigneault J, et. al. Solicited adverse events after influenza immunization among infants, toddlers, toddlers, and their contacts. Pediatrics. 2006;117(6):1963-1971.

US Food and Drug Administration. News Release, FDA approves vaccines for the 2012-2013 influenza season.  www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm315365.htm


 

[1] Seasonal influenza vaccinations are currently required for children aged 6 months through 59 months attending any child care or preschool facility in New Jersey and Connecticut. Since 2008, the New Jersey Department of Health and Senior Services has required administration of at least one dose of influenza vaccine to these children between September 1 and December 31 each year (New Jersey Administrative Code §8:57-4.19). Since 2010, the Connecticut Department of Public Health pursuant to its commissioner’s authority to establish vaccination schedules (see, Connecticut General Statutes §19a-7f) has required children aged 6 months through 59 months attending day care to receive at least one dose of influenza vaccine between September 1 and December 31 each year. Connecticut preschoolers (aged 24-59 months) are required to have one dose between August 1 and December 31 each year. Connecticut day care and preschool enrollees receiving influenza vaccine for the first time are required to have two doses of vaccine, administered at least 28 days apart. Connecticut children attending kindergarten classes are not required to have influenza vaccinations.

Effective Date: 
Tue, 01/21/2014

Adopted Rules: Closed to Comments

Adopted Rules Content: 

Statement of Basis and Purpose

 

Background

 

The Department is responsible under the Charter for supervising matters affecting the health of New Yorkers. This includes supervision of the reporting and control of chronic diseases and conditions hazardous to life and health.[1]  The Department also has specific responsibilities with regard to mental health.  Pursuant to section 552 of the Charter, the Department’s Division of Mental Hygiene (MHy) is the local government unit (LGU) for the City of New York under New York State Mental Hygiene Law, and the executive deputy commissioner who directs the Division is the City’s director of community services.  As the LGU, MHy is responsible for administering, planning, contracting, monitoring, and evaluating community mental health and substance abuse services within the City of New York. It also is charged with identifying needs and planning for the provision of services for high-need individuals, such as persons with schizophrenia and other psychotic illnesses.

Overview of Psychotic Illness

Schizophrenia and other psychotic illnesses include symptoms such as hallucinations, delusions, confused and disturbed thoughts, and a lack of self-awareness.[2],[3]  These illnesses usually begin in young adulthood[4],[5] and often place a significant quality of life and financial burden on both the individual with the illness as well as their families and loved ones.[6]  While previously thought to be chronically impairing, evidence now shows that early, high-quality treatment can reduce the risk of relapse, decrease the likelihood of debilitation, and increase chances for long-term remission for affected individuals.

 

DOHMH estimates that approximately 60,000 New Yorkers currently have psychotic illnesses.[7]  Despite evidence that treatment improves outcomes, we estimate only 40-50% of these New Yorkers receive ongoing psychiatric care following discharge from a psychiatric hospitalization.[8],[9]  Approximately 2,000 new cases of psychotic illness are expected to develop annually in New York City.[10],[11]  Without follow-up treatment, more than one quarter of these individuals will be expected to relapse and to be re-hospitalized within one year.[12],[13],[14],[15]  With treatment, the risk of relapse can be reduced by approximately 50%.[16],[17]

Impact of Duration of Untreated Psychosis and Early Intervention on Psychotic Illness

The ‘duration of untreated psychosis’ (DUP), the period from the first onset of psychotic symptoms to the start of treatment, is associated with both treatment effectiveness and long-term outcomes.[18],[19],[20]  Wespite the fact that shorter DUP is associated with better response to antipsychotic treatment, indicated by reduction in symptoms and better overall functioning, the average DUP is long (between one and three years in national studies).[21],[22],[23],[24]  In the medium and longer term (6 month, 12 month and multi-year follow-ups), longer DUP is associated with poorer outcomes for overall functioning, symptoms, and quality of life.[25][26]

DUP can be reduced by enhancing early detection, treatment and referral.  Early detection programs can bring people to treatment sooner, at lower symptom levels, and reduce DUP.[27],[28]

Implementing an early intervention model is also associated with better clinical and functional outcomes for individuals experiencing psychotic illness. This model involves a team-based approach (psychiatrists, social workers, peers) that includes community treatment, cognitive behavioral therapy, low-dose medication, family counseling, social skills training and vocational strategies.[29],[30],[31]  The effectiveness of early intervention programs has been demonstrated in a growing body of research.[32],[33],[34],[35],[36]

Adequacy of Current Links to Care

New Yorkers with psychotic illnesses often do not seek care or become disengaged from care.  This is due, in part, to:

·        fragmentation in the current mental health treatment system (patients being lost to care in transitions from hospitalization;

·        exchange of patient information unsupported by technology infrastructure or current administrative practices);

·        mental health treatment providers lacking resources to ensure links are established between patients and community supports; and

·        challenges such as stigma, denial, fear, lack of support, and confusion related to benefits and insurance.

As a result, there are many people who do not become engaged in care until years after the early stages of their illness.[37]

It is well-established that linking patients to care improves both health and economic outcomes for the individual and their loved ones and reduces the burden on the healthcare system.  Numerous studies, conducted with a variety of patient populations, highlight the importance and efficacy of linkage-to-care programs in improving post-hospitalization outpatient engagement, reducing the rate of re-hospitalization and decreasing associated costs.[38],[39],[40]

 

Amendment of Article 11

 

To improve linkages to care and outcomes for New Yorkers experiencing first episodes of psychosis, the  Board of Health is amending Article 11by requiring hospitals to report when persons  over 18 and under 30 years of age are admitted with a first episode of psychotic illness.

 

Reporting will be required within 24 hours of admission and will include hospital name, patient name, age, gender, address, telephone, date of admission, insurance type and diagnosis.  All patient information will be confidential and used only for the purposes of linking patients to care. Patient name, address, date of admission and telephone number will not be retained by the Department for longer than 30 days.  Information about patients agreeing to participate in the linkage-to-care program will subsequently be maintained in a program chart that is separate and apart from the information received from the reporting hospital.

 

Epidemiologic analysis

The de-identified data (hospital name, age, gender, month of admission, insurance type and diagnosis)in the reporting database will be used to describe characteristics of the aggregate population admitted with first-episode psychosis, in order to guide mental health system planning efforts.

 


[1]Charter §556(c)(2).

[2]Barbato, A. (1998)  WHO/MSA/NAM/97.6

[3] New York State Office of Mental Health (NYS OMH)(2012). Schizophrenia. Retrieved August 22, 2013 from: http://www.omh.ny.gov/omhweb/booklets/schizophrenia.html.

[4]Lewine RR. Amer J Orthopsychiat 1980;50:316-322.

[5]Kleinhaus K et al. J Psych Res 2011;45:136-141.

[6] Wu EQ, et al. J Clin Psych 2005;66:1122-1129.

[7]NYC DOHMH analysis of NYS OMH Patient Characteristics Survey, 2011.

[8] NYC DOHMH analysis of NYS Medicaid claims data, 2012.

[9] Buchanan RW, et al. Schiz Bull. 2010;36(1):71-93.

[10]Kirkbride JB et al.  Int J Epi.  2009; 38-1255-64.

[11]Bladwin P et al. Schiz Bull 2005 31;3, 624-38.

[12]NYC DOHMH Medicaid analysis.

[13]Zhomitsky S, et.al. Schiz Res Treatment. doi:10.1155/2012/407171

[14] Ram R, et al. Schiz Bull 1992;18:185-207.

[15]NYC DOHMH analysis of NYS Statewide Planning and Research Cooperative System, 2009.

[16]Alvarez-Jimenez M, et al.  Schiz Bull.  2011:37:619-630.

[17] Marshall M et al. Arch Gen Psych 2005; 62:975-983.

[18]Marshall M et al. Arch Gen Psych 2005; 62:975-983.

[19] Perkins D, et. al. Am J Psych 2005;162:1785–1804

[20]AddingtonJ.  Early Interv Psych 2007;1:294-307.

[21]Marshall M et al. Arch Gen Psych 2005; 62:975-983.

[22] Perkins D, et. al. Am J Psych 2005;162:1785–1804

[23] Hass G, et al. Schiz Bull. 1992; 18:373-386.

[24]Ho B, et al. Am J Psych 2000;157:808-815.

[25]Perkins D, et. al. Am J Psych 2005;162:1785–1804

[26]Petersen L, et al.  BMJ 2005;331:602. 

[27]Melle I, et al. Arch Gen Psych 2004;61:143–150.

[28]Hegelstad W, et al.  Am J Psych 2012;169:374-380.

[29]Grawe RW, et al. Acta Psych Scand 2006;114:328-336. 

[30]Mental Health Network NHS Confederation.2011 Issue 219.

[31] Singh SP. Br J Psych 2010; 196:343-345.

[32]Alvarez-Jimenez M, et al.  Schiz Bull.  2011:37:619-630.

[33]Hastrup LH, et al.  Br J Psych 2013;2002:35-41.

[34]Mihalopoulos C, et al. Schiz Bull 2009; 35:909-918.

[35] Norman RMG, et al.SchizResearch 2011;129: 111-115.

[36] Lieberman J, et al. JAMA 2013;310:689-690.

[37]Thornicroft G, (Commentary) Epi and Psych Sci. 2012;21:59-61

[38] Jack BW, et al.  Ann Intern Med.  2009; 150(3): 178-87.

[39] Coleman EA, et al.  Arch Intern Med.  2006; 166(17):1822-8.

[40] Naylor MD, et al. JAMA. 1999; 281(7):613-20.

Effective Date: 
Tue, 01/21/2014

Proposed Rules: Closed to Comments

Agency:
Comment By: 
Thursday, January 23, 2014
Proposed Rules Content: 

 

Statement of Basis and Purpose of Proposed Rule

Statutory Authority

This amendment to the New York City Health Code (“Health Code”) is proposed pursuant to Sections 556, 558 and 1043 of the New York City Charter (“Charter”).  Section 556 of the Charter grants the New York City Department of Health and Mental Hygiene (“Department”) jurisdiction to regulate all matters affecting health in the City of New York.  Specifically, Section 556 (c)(11) of the Charter authorizes the Department to regulate all aspects of ionizing radiation within the five boroughs of New York City. Sections 558 (b) and (c) of the Charter empower the Board of Health to amend the Health Code and to include in the Health Code all matters to which the Department’s authority extends.  Section 1043 of the Charter grants rule-making powers to the Department.

Section 228 of the New York State Public Health Law provides that local enactments like section 175.07 of the Health Code must be consistent with the requirements of the New York State Sanitary Code, as codified at Chapter I of Title 10 of the Codes, Regulations and Rules of New York State.  In order to be consistent with recent State Sanitary Code amendments involving updated quality assurance requirements for external beam and brachytherapy radiation treatment, the Department is proposing commensurate changes to the corresponding requirements in the Health Code. 

Background

The Department, through its Office of Radiological Health (“ORH”), regulates radioactive material for medical, research and academic purposes within the five boroughs of New York City.

ORH regulations for radiation machines and radioactive materials are contained in Article 175 of the Health Code.  ORH registers and inspects radiation machines, and licenses and inspects radioactive materials facilities for compliance with Article 175 for the protection of the health and safety of patients, radiation program employees and the general public.

There are about 6500 registered facilities possessing radiation machines and 375 licensed sites in New York City possessing radioactive material for medical, academic and research purposes. Of the registered facilities, approximately 6440 are registered diagnostic X-ray facilities and 60 are therapeutic X-ray facilities possessing certified registrations.

The State Sanitary Code was recently amended to reflect updated quality assurance requirements for external beam and brachytherapy radiation treatment (see, 10 NYCRR §16.24(a)). In order to maintain consistency, the Department is proposing to make commensurate changes to its corresponding requirements in §175.07(c) of Article 175 of the Health Code.

Proposed Rule Elements and Goals

The Department proposes that the Board of Health repeal current subdivision (c) of §175.07 and replace it with a new subdivision (c) that includes updated quality assurance standards for radiation materials licensees or radiation equipment registrants who are authorized to administer external beam therapy or brachytherapy to humans.  The new subdivision includes quality standards appropriate for newer, more complex radiation therapy treatment systems and also requires additional verification of radiation set-up equipment and treatment plans prior to administering radiation treatments to patients.  New subdivision (c) also requires quality assurance programs to cover data communication/transfer between component systems of planning and treatment delivery systems to ensure complete, uncorrupted data transfer.  Additionally, the new subdivision requires licensees and registrants to credential individuals involved in quality assurance testing, treatment planning, and radiation treatment of patients.  Finally, new subdivision (c) requires licensees and registrants to be accredited in radiation oncology by the American College of Radiology or the American College of Radiation Oncology, or another equivalent accrediting organization, within 18 months of the effective date of the rule.

The New York City Board of Health’s authority for these rules is found in sections 556, 558 and 1043 of the City Charter.  This proposed rule implements particular standards  set forth in newly enacted state regulations with only minor exercise of the Board’s discretion.  Pursuant to section 1043(d)(4)(iii), the analysis required by Section 1043(d) of the Charter was not performed.

 

Subject: 

Radiation Control (Article 175) - Quality Assurance

Location: 
Gotham Center
42-09 28th Street, 14th Floor, CN31
Long Island City, NY 11101-4132
Contact: 

Svetlana Burdeynik, resolutioncomments@health.nyc.gov
Phone: (347) 396-6078
New York City Department of Health and Mental Hygiene
Board of Health

Download Copy of Proposed Rule (.pdf): 

Proposed Rules: Closed to Comments (View Public Comments Received:3)

Agency:
Comment By: 
Monday, November 18, 2013
Proposed Rules Content: 

 

 

Statement of Basis and Purpose of Proposed Rule

 

Statutory Authority

This amendment to the New York City Health Code (“Health Code”) is proposed pursuant to Sections 556, 558 and 1043 of the New York City Charter (“Charter”). Section 556 of the Charter grants the New York City Department of Health and Mental Hygiene (“Department”) jurisdiction to regulate all matters affecting health in the City of New York. Sections 558 (b) and (c) of the Charter empower the Board of Health to amend the Health Code and to include in the Health Code all matters to which the Department’s authority extends. Section 1043 of the Charter grants rule-making powers to the Department. It also is being proposed pursuant to §3554(3) of the Public Health Law and 10 NYCRR §§72-1.1(d) and 72-1.2(b) and (c)i, which allow the New York State Department of Health to authorize local jurisdictions, such as the Department, to enact and enforce local regulations concerning tanning facilities.

 

Background

As the U.S. Food and Drug Administration (FDA) has warned, “There is no such thing as a safe tan.”ii Tans are caused by the skin’s reaction to ultraviolet (UV) radiation and any exposure to UV rays can lead to skin cancer and other diseases. Ultraviolet radiation devices, or “indoor tanning devices,” are devices available at many facilities for members of the public to use to tan. In the State of New York, they generally are regulated by the New York State Department of Health under Article 35-A of the Public Health Law. Pursuant to State Department of Health regulations, local health departments, however, may request and be given authority by the State to regulate their operation locally.iii The Department has made such a request to regulate indoor tanning devices in the City of New York.

 

Tanning and Cancer

Users of indoor tanning devices are at risk for multiple adverse health consequences. The World Health Organization’s International Agency for Research on Cancer (IARC) classifies indoor tanning devices, which emit UV radiation, as “Group 1”iv carcinogens because there is “sufficient evidence” that their use causes “carcinogenicity in humans.” v  The IARC based its classification on evidence showing associations between indoor tanning and skin cancer (both melanoma and carcinoma) and eye cancer (ocular cancer).vi It observed that the risk of melanoma is “increased by 75% when the use of tanning devices starts before 30 years of age.”vii The U.S. Department of Health and Human Services’ National Toxicology Program similarly classifies tanning devices as, “known to be human carcinogens.”viii Skin cancer is the most common form of cancer in the United States, and annually costs the country an estimated $1.7 billion in medical costs and results in $3.8 billion in lost productivity.ix In New York State, approximately 2,000 men and 1,500 women are diagnosed with melanoma each year (averaged over 2005 through 2009)x.

 

Other Risks of Tanning

In addition to increasing the risk of certain cancers, the use of indoor tanning devices can also cause ocular damage, premature aging of the skin, immune system repression and exacerbation of pre-existing medical conditions.xi Indoor tanners may also experience serious burns requiring emergency medical treatment. In the U.S., according to the FDA, an average of 1,800 emergency department visits are caused by UV tanning devices every year, and the number of burn cases treated by doctors or urgent care clinics is probably significantly higher.xii A study of adolescent indoor tanning practices between 1998 and 2004 found that over 60% of indoor tanners between the ages of 16 and 18 years old reported experiencing erythema, or burns, after indoor tanning sessions.xiii

 

Frequency and Risk

The earlier a person begins indoor tanning and the more frequently they tan, the greater the risk is that they will develop skin cancer. Research has demonstrated a strong “dose response” relationship between melanoma risk and the total hours of indoor tanning over a lifetime. This means the risk of cancer from indoor tanning is cumulative and increases with every use.xiv Early and frequent use of indoor tanning devices, however, is not uncommon. While minors under the age 17 are legally prohibited from tanning in the state of New York, (Chapter 105, Laws of 2012), the use of tanning among older adolescents and young adults is prevalent and frequent. The most recent national Youth Risk Behavior Survey (YRBS, 2011) found that approximately 40% of non-Hispanic white females ages 17-18 have used a tanning device in the last year and that approximately 24-30% of that group reporting tanning at least 10 times in the last 12 months.xv A similar study of adults (the National Health Interview Survey, 2010) found that approximately 30% of non-Hispanic white females between the ages of 18-25 reported indoor tanning at least once annually.xvi Among adults who tan, approximately 50 percent reported using tanning devices more than 10 times in a year, with women reporting that they use them an average of 20 times per year.xvii Among youths ages 16 to 18 who tan indoors, the average number of visits is approximately nine times per year.xviii Multiple studies have shown that the repeated use of indoor tanning may result in behavioral consequences, including physical and psychological addiction to tanning. In other words, the more people tan, the more they feel compelled to tan, increasing their health risks.xix

 

Efforts to Reduce Tanning

Despite the large body of evidence documenting the health risks associated with indoor tanning, indoor tanning rates have continued to increase.xx

 

A study of university-age students found that the students’ general understanding of the health risks associated with indoor tanning did not influence their decision to indoor tan.xxi A study by the FDA of its own warning material found that a modified warning message “may more effectively convey [the] risks [of indoor tanning] than the current labeling requirements,” which mandate that labels state factual information about the dangers of indoor tanning devices.

 

Proposed Rule Elements and Goals

The Department would, if approved, assume regulatory authority of tanning facilities within New York City from the New York State Department of Health. Consistent with State law, these rules are being proposed as part of that oversight.

 

The proposed rules are intended to reduce the risk of tanning-related health effects among tanning facility patrons by increasing the awareness of the risks of indoor tanning and establishing the safer and more sanitary operation of tanning facilities. These rules: 1) provide definitions and requirements for permit issuance, inspection and operation of tanning facilities, and 2) would enable the Department to apply successful strategies used successfully to change risky behavior.

 

The New York City Department of Health and Mental Hygiene’s authority for these rules is found in sections 556, 558 and 1043 of the City Charter and section §3554(3) of the New York State Public Health Law.

 

 

 

i           New York Codes, Rules and Regulations, (NYCRR), Title 10, Part 72, Subpart 72-1. Electronic version: http://www.health.ny.gov/regulations/nycrr/title_10/part_72/subpart_72-1.htm  

ii          FDA, The Risks of Tanning:  http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/Tanning/ucm116432.htm.

iii         New York Codes, Rules and Regulations, (NYCRR), Title 10, Part 72, Subpart 72-1.

iv         Group 1 is the IARC’s highest cancer risk category and includes other well-established carcinogens like asbestos, arsenic and tobacco smoke. IARC, Agents Classified by the IARC Monographs, Volume 1-104:  http://monographs.iarc.fr/ENG/Classification/ClassificationsGroupOrder.pdf.

v          IARC, Preamble: http://monographs.iarc.fr/ENG/Preamble/CurrentPreamble.pdf .

vi         IARC Monographs on the Evaluations of Carcinogenic Risks to Humans, Volume 100, Part D: Radiation. WHO Press, 2009. See also, Special Report: Policy, A Review of Human Carcinogens – Part D: Radiation. The Lancet ,August, 2009; and Zhang et al., Use of Tanning Beds and Incidence of Skin Cancer, Journal of Clinical Oncology, May 10, 2012.

vii        IARC, 2009; See also, Dennis K. Woo and Melody J. Eide. Tanning Beds, Skin Cancer, and Vitamin D: An Examination of the Scientific Evidence and Public Health Implications, Dermatologic Therapy, 2010.

viii       U.S. Department of Health and Human Services, Public Health Services, National Toxicology Program, Report on Carcinogens, 12th ed.: Exposure to Sunlamps or Sunbeds (2011).

ix         CDC Morbidity and Mortality Weekly Report, Use of Indoor Tanning Devices by Adults – United States, 2010. Volume 61, Number 18. May 11, 2012; see also Bickers et al., The Burden of Skin Disease. Journal of American Academy of Dermatology. 2006.

x          New York State Department of Health, New York State Cancer Registry. Skin Cancer in New York State, Fifth Annual Report to the Governor of New York, the Temporary President of the Senate, and Speaker of the Assembly, 2012. Report available at: http://www.health.ny.gov/statistics/diseases/cancer/skin/report/docs/2012_report.pdf

xi         James M. Spencer and Rex A. Amonette. Indoor Tanning: Risks, Benefits, and Future Trends, Journal of the American Academy of Dermatology (1995).

xii        National Electronic Injury Surveillance System, CDC. Reported on FDA website: http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/ucm116447.htm  

xiii       Cokkinides et al. Indoor Tanning among Adolescents in the US, 1998 to 2004. Cancer, January 2009.

xiv      Lazovich et al.. Indoor tanning and risk of melanoma: a case-control study in a highly exposed population. Cancer Epidemiol Biomakers Prev. June, 2010.

xv       Guy et al. Indoor Tanning Among Young Non-Hispanic White Females. Journal of the American Medical Association, Internal Medicine, Letters. Published online August 19, 2013; See also, Mayer et al.. Adolescents’ Use of Indoor Tanning: A Large-Scale Evaluation of Psychosocial, Environment, and Policy-Level Correlates. American Journal of Public Health. May, 2011. See also Cokkinides et al.. Use of indoor Tanning Sunlamps by US Youths, Ages 11-18 Years, and by their Parent of Guardian Caregivers: Prevalence and Correlates. Pediatrics. 2002. American Journal of Public Health. May, 2011.

xvi      Guy et al., 2013; See also reference ix, CDC MMWR, 2012.

xvii     See reference ix, CDC MMWR, 2012.

xviii    See reference xiii, Cokkinides et al., 2009.

xix      David E. Fisher and William D. James. Indoor Tanning – Science, Behavior, and Policy. New England Journal of Medicine. September 2010; see also, Catherine E. Mosher and Sharon Danoff-Burg. Addiction to Indoor Tanning: Relation to Anxiety, Depression, and Substance Use. Arch Dermatol, April, 2010.

xx       See reference vii Woo et al.; See also Purdue et al.. Recent Trends in incidence of cutaneous melanoma among U.S. Caucasian young adults. Journal of Investigative Dermatology. December. 2008: 128(12), 2905-2908

xxi      Knight et al.. Awareness of the Risks of Tanning lamps Does Not Influence Behavior Among College Students. Arch Dermatol. October, 2002.

 

 

 

 

Keywords:
Subject: 

The New York City Department of Health and Mental Hygiene (DOHMH) is proposing that the Board of Health amend the New York City Health Code to create a new Article 177, “Tanning Facilities.” The Department intends to assume regulatory authority over indoor tanning facilities operating in New York City from the New York State Department of Health. Article 177 will include rules regulating the licensure, operation and inspection of these facilities.

Location: 
New York City Department of Health and Mental Hygiene
42-09 28th Street, 14th Floor, Room 14-34,
Long Island City, NY 11101-4132
Contact: 

Svetlana Burdeynik
New York City Department of Health and Mental Hygiene
Board of Health
42-09 28th Street, 14th Floor, CN31
Long Island City, NY 11101-4132
(347) 396-6078

Download Copy of Proposed Rule (.pdf): 

Pages