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Adopted Rules: Closed to Comments

Adopted Rules Content: 
 

                                                                       Statement of Basis and Purpose    

 

Statutory Authority

            The Board’s authority to codify these proposed amendments is found in Sections 556, 558 and 1043 of the New York City Charter (the “Charter”).  Sections 558(b) and (c) of the Charter empower the Board to amend the Health Code and to include all matters to which the Department’s authority extends.  Section 556 of the Charter provides the Department with jurisdiction to protect and promote the health of all persons in the City of New York.  Section 1043 grants the Department rule-making authority.

Background       

The Department is responsible under the Charter for supervising matters affecting the health of New Yorkers.  Through its Division of Disease Control, the Department conducts disease surveillance and control activities for most of the diseases listed in Article 11 (Reportable Diseases and Conditions) of the Health Code.  The same Division also enforces Article 13 (Clinical Laboratories) of the Health Code, which regulates the performance of laboratory tests and the reporting of test results.  In addition, the Department must comply with various provisions of Part 2 of the New York State Sanitary Code, found in Title 10 of the New York Codes, Rules and Regulations (NYCRR), with respect to the control of communicable diseases.

To conduct more effective, timely, and complete disease surveillance and control, the Department proposed to the Board and the Board is amending Health Code Articles 11 and 13 as follows:

Tuberculosis Infection Reporting

The Board is amending Health Code Sections 11.03(a) and 13.03(b)(1) to require laboratories to report all test results for tuberculosis (TB) infection, including negative results. Prior to the adoption of these amendments, the Health Code required reporting only of test results and other information attendant to active TB disease, and tests positive for TB infection and related information for children under five years old.

TB is a disease caused by the bacterium Mycobacterium tuberculosis, which is spread person-to-person through the air. Most commonly, TB disease affects the lungs, but it can also affect other parts of the body. Individuals who have a positive test for TB infection but do not have symptoms or other test results consistent with active TB disease are diagnosed with latent TB infection (LTBI). Persons with LTBI are asymptomatic and cannot transmit the infection to others. It is estimated that approximately 10 percent of individuals with LTBI will develop active TB disease at some point in their life. Treating LTBI is the only way to significantly reduce the risk of developing active disease and thus is a vital component of TB prevention efforts.

There is no reliable data on the prevalence of LTBI in the United States or New York City. National estimates from the National Health and Nutrition Examination Survey study, when combined with New York City population data, result in an estimate of approximately 700,000 people with LTBI in the City. However, data from the Department’s TB clinics suggests there could be as many as 1.8 million people in New York City with LTBI. Based on these estimates, there is a large reservoir of TB infection in New York City, some of which will result in future cases of active TB disease.

While the Department has made major strides in reducing the number of active TB cases in New York City – from 3,755 at the height of the TB epidemic in 1992 to 559 in 2018 – the number of TB cases has largely plateaued in the last 10 years. The Department is working to expand its efforts to identify and treat people with LTBI to further reduce the burden of TB in New York City, and reporting of test results for TB infection will help focus that effort.

Reporting of tests for TB infection will give the Department a better understanding of the prevalence of TB infection in order to better direct public health resources. Also, the data collected will provide information about testing practices, which will help inform provider outreach. Reports of laboratory tests negative for TB infection will provide the Department with a more complete picture of testing practices and allow for better estimates of testing prevalence to inform the Department’s programming.

In addition, the Board has made minor related language changes to Health Code § 11.21(a) for consistency.

In response to public comments received, the language of the Department’s proposal as to this provision has been revised to clarify that laboratories must report all test results, including negatives, for tests for TB infection only, and not tests performed in connection with diagnosing or monitoring active TB disease, such as mycobacteria culture tests.

Syphilis Amendment Proposal

The Board is adding a new Section 11.33 to the Health Code to require healthcare providers to test pregnant persons for syphilis at 28 weeks of pregnancy, or as soon thereafter as reasonably possible but no later than at 32 weeks of pregnancy, and that test results and a treatment plan be documented.

Syphilis is a sexually transmitted infection caused by the bacterium Treponema pallidum. Untreated syphilis during pregnancy can result in devastating health outcomes, including stillbirth.  Infants with congenital syphilis may manifest abnormalities of the central nervous system, bones and joints, teeth, eyes, and skin. In New York City, the number of congenital syphilis cases increased 186% between 2017 (7 cases) and 2018 (20 cases). Twenty is the largest number of congenital syphilis cases reported in the City in over ten years and included one syphilitic stillbirth at 31 weeks. In general, New York City has much higher rates of primary, secondary, and early latent syphilis as compared to the U.S. population. In 2017, the rate of syphilis at all stages was 95.33 per 100,000 in NYC vs. 31.4 cases per 100,000 nationally. Syphilis is increasing among New York City women; from 2017 to 2018, the number of primary, secondary, and early latent syphilis cases among NYC women increased 44%, from 219 to 315 cases.

Congenital syphilis can be prevented by timely treatment of maternal syphilis. However, symptoms of maternal syphilis during pregnancy may not be apparent, so serologic screening during pregnancy is critical. New York State mandates syphilis screening at the first prenatal care examination (NYS Public Health Law § 2308) and at delivery (10 NYCRR § 69-2.2). Increasingly, the Department has documented congenital cases resulting from maternal syphilis infections acquired subsequent to screening negative earlier during pregnancy; this accounted for 11 cases (55%) of congenital syphilis cases in 2018. At least half of these cases may have been averted by screening women at 28 weeks of pregnancy.

The Board adopts the Department’s proposal to require an additional syphilis test at 28 to 32 weeks of pregnancy to identify pregnant people who become infected subsequent to initial mandatory screening, which will enable treatment, improve the health of the pregnant person, and prevent potentially grave health outcomes attendant to vertical transmission. Requiring documentation of test results and a treatment plan will help ensure appropriate follow-up care. Twenty-eight weeks is the most appropriate time for third trimester re-screening because other screening tests are routinely performed at 28 weeks, and because screening at this time would allow sufficient time to treat pregnant people who have syphilis prior to delivery. These changes now align the Health Code with laws in several other states that require third trimester syphilis testing of all pregnant persons. 

Exclusion of Cases and Carriers of Enteric Pathogens

The Board is amending Health Code § 11.15(a) to provide the Department with the discretion to end “exclusion” of people infected with enteric pathogens when doing so is appropriate under the circumstances.

Under the Health Code, individuals infected with or carrying certain enteric pathogens were required to be excluded from certain settings where there was an elevated risk of disease transmission. Thus, cases and carriers who are food handlers or health care workers have to be excluded from their place of work, and staff and attendees of schools, child care programs, camps, and other facilities attended by children under five years of age had to be excluded from those facilities. Under the current provision, the Health Code provides that exclusion can end only when the excluded person no longer has symptoms and the Department had received two or three (depending on the pathogen) successive negative stool specimens demonstrating that transmission is no longer likely and that the excluded person’s illness is no longer a public health concern.

The enteric diseases addressed in Health Code § 11.15 – Campylobacteriosis, Cholera, Escherichia (E.) coli 0157:H7 and other Shiga toxin-producing E. coli (STEC) infections, Salmonellosis (other than typhoid), Shigellosis, Yersiniosis, Amebiasis, Cryptosporidiosis, and Giardiasis – are transmitted via the fecal-oral route. People infected with or carrying enteric pathogens who are food handlers, health care workers providing oral care or feeding, child care workers, or child care attendees can shed the organism in their stool and transmit the infection to others if they have poor hand hygiene practices. Exclusion can last from days to months.

The number of people identified requiring exclusion has increased significantly in recent years. In 2018, there were 187 exclusions ranging in duration from 1 to 135 days, with a mean length of 22 days, as compared to 69 exclusions in 2015. The increase in exclusions is due to improved surveillance practices and increased use of culture-independent diagnostic tests (CIDT), a testing method that is more sensitive than other types of traditional tests, leading to more positive test results. Stool samples can be positive by a CIDT but negative by traditional tests, such as bacterial culture, indicating that although the organism’s DNA is detectible, it may not be alive and capable of being transmitted. However, under the Health Code provision prior to the adoption of these changes, individuals have to be excluded based on the positive CIDT result while awaiting for multiple follow-up culture results. Also, some individuals shed the organism in the stool for many weeks or months even after symptoms have ended, and experience suggests that the risk of transmission in that circumstance is low. As there are no clear national guidelines on exclusion, exclusion requirements of jurisdictions vary. Many jurisdictions, including New York State, are less strict than New York City without any measured increase in disease transmission.

For these reasons the Department proposes a more flexible approach that takes into consideration the circumstances of a particular case, including the type of infection, the type of test used to detect the pathogen, the presence or absence of symptoms, the individual’s treatment with antimicrobial drugs, the individual’s job responsibilities, and the likelihood of infectiousness based on the length of time since symptom onset. The adoption of this proposal still allows the Department to exclude people with enteric pathogens until consecutive negative test results are received if, in the view of Department experts, there remained a public health threat. However, the Department would have the discretion to allow people to return to work or school sooner if their illness no longer poses a risk to others.

In addition, the Board is adopting is minor language changes to this provision for consistency and clarity, and to correct typographical errors.


Campylobacter Testing and Reporting

The Board is amending Health Code § 13.03(b) to no longer require laboratories to perform culture testing on all specimens found to be positive for Campylobacter by CIDT. Culture testing involves a laboratory using a specimen to grow the pathogen; a sample of the pathogen grown by culture is termed an “isolate”.

In January 2017, the Health Code was amended to require follow-up culture tests on the following enteric pathogens: Campylobacter, Listeria monocytogenes, Salmonella, Shigella, Vibrio, Yersinia, and Shiga toxin-producing Escherichia coli. The laboratory must report the results of the culture and submit any resulting isolates to the Department. The Department proposed the amendment to enable it to obtain information about the pathogens not available from CIDT and used to assist in outbreak detection and response.

Campylobacter bacteria can be transmitted to people through contaminated food and liquid or contact with certain animal feces. It causes diarrhea, fever, and abdominal cramps and, in rare cases, more serious illness. Compared to other enteric pathogens, Campylobacter is difficult to isolate and found relatively frequently, particularly given an increase in positive test results stemming from more expansive use of CIDT. Further, other enteric pathogens that are required to be cultured per the Health Code, including Salmonella and Shiga toxin-producing Escherichia coli, have more significant public health consequences than Campylobacter, including that they are more likely to be part of local and multi-state disease outbreaks.

The Department has determined that appropriate monitoring of Campylobacter can occur without routine culture testing and isolate submission. Given the high number of Campylobacter reports (approximately 2500 cases in New York City in 2018), the Department generally has been able to investigate only clusters, as opposed to isolated cases. Accordingly, the Department does not make use of most of the isolates received from laboratories. The Department can request additional testing and isolates from laboratories in the event of a suspected cluster or outbreak, rather than requiring laboratories to perform the additional testing as a matter of course. The Department believes this approach better balances laboratory burden and public health needs.

In addition, in order to address questions raised by reporting laboratories, the Board is adopting minor language changes to clarify that reports must be sent to the Department.

 
 
Effective Date: 
Fri, 11/15/2019

Adopted Rules: Closed to Comments

Adopted Rules Content: 
 

Statement of Basis and Purpose

  

Tobacco use is a leading cause of premature, preventable death in the City, killing an estimated 12,000 people annually. All tobacco products — including cigars, smokeless tobacco, tobacco containing shisha and others — are inherently dangerous, and contain nicotine, which is addictive. Despite the City’s progress in reducing cigarette smoking among youth and adults, an increasing percentage of youth are using other tobacco products (OTP) like cigars, waterpipes (hookahs), and smokeless tobacco.

According to the World Health Organization, raising prices through tobacco taxes is the single most effective way to decrease tobacco use. Taxation reduces tobacco use by reducing youth initiation, encouraging tobacco users to quit, and reducing consumption among those who do not quit. Similarly, increased minimum prices for tobacco products can also decrease tobacco consumption. Given relatively high levels of taxation on cigarettes at the federal, state, and local levels, OTP are generally less expensive than cigarettes, increasing their attractiveness as cheaper alternatives. In 2017, Local Law 145 was enacted to reduce the prevalence of OTP use, particularly among youth, utilizing two strategies: first, it establishes price floors for OTP and second, it imposes taxes on OTP. 

Local Law 145 establishes minimum package sizes for cigarettes, tobacco products and non-tobacco shisha that complement the price floors. In contrast to cigarettes, which are required to be packaged and sold in packages of 20, the OTP regulated by Local Law 145 are not packaged or sold in a standardized manner, with the exception of little cigars which are sold and packaged like cigarettes. When OTP is offered for sale in relatively small, inexpensive quantities, it may facilitate experimentation with tobacco by non-tobacco users, potentially contributing to addiction, and help tobacco users to sustain their addiction at little cost.  To address this, Local Law 145 prohibits retail dealers from selling little cigars, snus, shisha and non-tobacco shisha, and loose tobacco unless such products are sold in the prescribed package size. 

To bring the Department’s rules into agreement with Local Law 145, two sections of Chapter 13 of Title 24 of the Rules of the City of New York are being repealed and readopted. Specifically, section 13-02, which prohibits the sale of cigarettes or the sale of tobacco products for less than the listed price, is repealed and readopted to add definitions for terms used in the rule that are consistent with those in Local Law 145. Section 13-03 is repealed and readopted to reflect the price floors required by Local Law 145 for OTP products in a range of quantities to account for the variation in the packaging and quantity of the products sold.

In addition, the Department is repealing section 13-04 of chapter 13, which prohibited retail dealers from selling cigars unless they were sold in a package of at least four cigars, because Local Law 145 eliminated this requirement and replaced it with a prohibition on the sale of any cigarette or tobacco product outside of the package provided by the manufacturer.  The Department is also repealing section 13-05 of chapter 13, which prohibits the sale of cigarettes and tobacco products to persons less than twenty-one years of age, because the rule does not elaborate on the prohibition imposed by the Administrative Code and, since the Department of Consumer Affairs (DCA) enforces this prohibition, there is no need for it to be repeated in the rules of the Department.  

 
Effective Date: 
Thu, 10/11/2018

Proposed Rules: Closed to Comments

Agency:
Comment By: 
Thursday, August 2, 2018
Proposed Rules Content: 
 
 

Statement of Basis and Purpose of Proposed Rule

Tobacco use is a leading cause of premature, preventable death in the City, killing an estimated 12,000 people annually. All tobacco products—including cigars, smokeless tobacco, tobacco containing shisha and others—are inherently dangerous, and contain nicotine, which is addictive. Despite the City’s progress in reducing cigarette smoking among youth and adults, an increasing percentage of youth are using other tobacco products (OTP) like cigars, waterpipes (hookahs), and smokeless tobacco.

According to the World Health Organization, raising prices through tobacco taxes is the single most effective way to decrease tobacco use. Taxation reduces tobacco use by reducing youth initiation, encouraging tobacco users to quit, and reducing consumption among those who do not quit. Similarly, increased minimum prices for tobacco products can also decrease tobacco consumption. Given relatively high levels of taxation on cigarettes at the federal, state, and local levels, OTP are generally less expensive than cigarettes, increasing their attractiveness as cheaper alternatives. In 2017, Local Law 145 was enacted to reduce the prevalence of OTP use, particularly among youth, utilizing two strategies: first, it establishes price floors for OTP and second, it imposes taxes on OTP.  The proposed rules address the OTP price floors.

In contrast to cigarettes, which are required to be packaged and sold in packages of 20, the OTP regulated by Local Law 145 are not packaged or sold in a standardized manner, with the exception of little cigars which are sold and packaged like cigarettes. The Department is proposing these rules to publicize the price floors of the OTP products for a range of quantities to account for the variation in the packaging and quantity of the products sold.

Local Law 145 sets minimum pack sizes for OTP, complementing the price floors. When OTP is offered for sale in relatively small, inexpensive quantities, it may facilitate experimentation with tobacco by non-tobacco users, potentially contributing to addiction, and help tobacco users to sustain their addiction at little cost. 

The proposed amendment is as follows:

 “Shall” and “must” denote mandatory requirements and may be used interchangeably in the rules of this department, unless otherwise specified or unless the context clearly indicates otherwise.

 

Subject: 

Proposal to amend Chapter 13 of Title 24 of the Rules of the City of New York to clarify requirements related to Local Law 145 of 2017, which imposes a tax on tobacco products other than cigarettes (OTP), creates minimum prices for cigarettes and OTP, and sets minimum pack sizes for various OTP.

Location: 
New York City Department of Health and Mental Hygiene, Gotham Center
42-09 28th Street, 8th Floor, Room 8-25
Queens, NY 11101
Contact: 

Svetlana Burdeynik, (347) 396-6078, resolutioncomments@health.nyc.gov

Download Copy of Proposed Rule (.pdf):