DOHMH

Working with the City’s rulemaking agencies, the Law Department, the Mayor’s Office of Management and Budget, and the Mayor’s Office of Operations conducted a retrospective rules review of the City’s existing rules, identifying those rules that could be repealed or modified to reduce regulatory burdens, increase equity, support small businesses, and simplify and update content to help support public understanding and compliance. This proposed rule repeal was identified as meeting the criteria for this initiative.

Statement of Basis and Purpose of Proposed Rule

Statutory Authority

The repeal and restatement of Chapter 7 of Title 24 of the Rules of the City of New York and repeal of   Title 25 of the Rules of the City of New York is authorized by §§555(b)(2), 556, 558(b) and (e), and 1043 of the New York City Charter (the “Charter”) and §3.11 of the New York City Health Code.

    • Section 556 of the Charter authorizes the Department of Health and Mental Hygiene (the “Department”) to regulate all matters affecting health in the City of New York. 

    • Section 555(b)(2) of the Charter authorizes the Commissioner of Health and Mental Hygiene to assess penalties for health-related regulations.

    • Section 558 of the Charter authorizes the Board of Health to set civil penalties for the enforcement of the Health Code.

    • Section 1043 of the Charter gives the Department rulemaking powers.

Background of Proposed Rule

    1. Repeal and restate Chapter 7 of Title 24 of the Rules of the City of New York

Historically, civil violations of the Health Code were adjudicated at a tribunal established by the Board of Health pursuant to §558(e) of the New York City Charter.  On November 2, 2010, however, New York City voters approved an amendment to the Charter authorizing the Mayor to consolidate certain administrative tribunals into the Office of Administrative Trials and Hearings (OATH) by Executive Order.

On July 3, 2011, the Department’s Administrative Tribunal established by the Board of Health was transferred to OATH by Executive Order No. 148 (June 8, 2011) (the “Executive Order”) and renamed the Health Tribunal at OATH. Subsequently, in 2015, the Tribunal became part of the OATH Hearings Division, which now hears and adjudicates violations issued by other City agencies as well as the Department.   

After the Department’s Administrative Tribunal was transferred into OATH, on December 13, 2011 the Board of Health repealed Article 7 (“Administrative Tribunal”) of the Health Code, which contained provisions for conduct of the Administrative Tribunal.  OATH has its own rules of procedure for the Health Tribunal at OATH, which are found in Chapter 6 of Title 48 of the Rules of the City of New York. Subdivision (b) of Health Code §3.12 (“Administrative Tribunal and Environmental Control Board proceedings”) now confers jurisdiction on the Health Tribunal at OATH  and the Environmental Control Board (“ECB”) to hear all violations of the Health Code or any other State or local law or regulation that the Department enforces by seeking fines and monetary penalties. The same subdivision also provides that any such proceeding will be adjudicated in accordance with applicable procedures of the Health Tribunal at OATH or ECB. 

Chapter 7 of the Department’s rules pre-dates the transfer of the Administrative Tribunal to OATH and the Board of Health’s repeal of Article 7 of the Health Code.  Accordingly, Chapter 7 still refers to the Department’s former Administrative Tribunal and must be amended to accurately reflect that OATH’s Hearings Division now adjudicates all cases where the Department is seeking monetary penalties for violations of the Health Code.  

Chapter 7 also authorizes the Commissioner to delegate authority to OATH to hear cases and make findings of fact and recommendations in due process or “show cause” hearings.  These adjudications request reports and recommendations to the Commissioner of Health regarding such matters as permit and license revocations and employee misconduct and discipline and will continue to be held at the OATH Trials Division, and thus this authorization will remain in the restated Chapter 7.  

Because the changes to Chapter 7 are so extensive, the Chapter is being repealed and restated. 

   2. Codify violation penalties

Section 6-02 of OATH’s rules requires that it impose fines and other penalties in accordance with applicable law. Penalties for the violations adjudicated in ECB have been established in ECB’s (and now OATH’s) rules for many years. 

The Health Code establishes penalty ranges for violations adjudicated in the OATH Hearings Division.  OATH hearing officers continue to exercise discretion in deciding penalty amounts to be imposed for violations they sustain, provided the amounts are within the range prescribed by the Health Code.

OATH, however, is requesting that all City agencies establish by rule fixed penalties for the violations they are adjudicating in its Hearings Division.  OATH has also indicated that it will be repealing the penalty schedules in its rules for ECB cases and that agencies should also adopt by rule penalties for violations being adjudicated in that tribunal.

In 2014, the Department amended Chapter 23 of Title 24 to establish penalties for violations issued to food service establishments.  The Department is now proposing to amend Chapter 7 to set penalties for other violations of the Health Code, Department rules and other applicable law enforced by various Department programs. The new fixed penalties include those for violations currently adjudicated at the OATH Hearings Division.  Food service establishment penalties will remain in Chapter 23. Mobile food vending penalties are not included in this Chapter, but the Department expects to incorporate them in a new appendix to Chapter 6 of these rules.

To further promote compliance and prompt correction of hazardous conditions, the penalties proposed by the Department are heightened for some repeat offenses, considered continuous for others and in the case of standing water violations, the penalties reflect the magnitude of the violation.  These terms are defined in the rules and specified in the violation descriptions.  Sustained repeat violations citing rats, rat signs, rat harborage and conditions conducive to rats carry minimum, maximum and accelerated penalties in accordance with §17-133.1 of the Administrative Code of the City of New York. 

Penalties for violations of repealed Health Code and other provisions of law contained in current ECB rules have been excluded from the proposed penalty table, including those for violations of Article 153 and §§139.05, 139.07 and 181.03. Also excluded are penalties for violations that are already specified in a provision of the Health Code or Administrative Code, or in a particular Department rule or other applicable law.

   3. Repeal Title 25 of the Rules of the City of New York

In the November 2001 general election, New York City voters approved an amendment of the Charter to establish a “Department of Public Health” (later changed to the “Department of Health and Mental Hygiene”) combining the former Departments of Health (DOH) and Mental Health, Mental Retardation, and Alcoholism Services (DMHMRAS). All employees of both agencies became employees of the combined DOHMH.  The only existing provision in Title 25 of the Rules of the City of New York of the former DMHMRAS is §1-01 (Conduct of Adjudicatory Hearings) of Chapter 1 (Adjudications), relating to employee fitness and disciplinary hearings. Title 25 is no longer necessary because of the merger of the two agencies, and the Department proposes to repeal it.

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.

Statement of Basis and Purpose of Proposed Rule

Background

In 1971, the Board of Health amended section 207.05 of the New York City Health Code to allow the Department to file a new birth certificate with a corrected gender marker of male or female for a person who both obtained a court order changing his or her name and who underwent “convertive” surgery.  The Department had, generally but not exclusively, interpreted the requirement for convertive surgery to mean genital surgery.  As a result, transgender applicants requesting new birth certificates were required to submit medical records demonstrating that they had undergone genital surgery to change sex and the number of requests for a corrected birth certificate was relatively small.  For example, in 2012, the number of new birth certificates approved and issued to transgender applicants was 20 and, in 2013, only 22 new birth certificates were issued.

In 2014, the Board of Health amended Section 207.05(a)(5) to eliminate the requirement for convertive surgery.  This amendment allowed the Department to issue a new birth certificate with a changed gender marker of male or female based on an affirmation from a physician licensed to practice in the United States, or an affidavit from a doctoral-level psychologist clinical social worker, physician assistant, nurse practitioner, marriage and family therapist, mental health counselor, or midwife, licensed to practice in the United States.  Eliminating the surgery requirement led to a dramatic increase in requests for new birth certificates; from January 2015, when the amendment became effective, through February 2018, the Department issued 1,047 new birth certificates to transgender applicants.

Proposed Amendment

The Department is now proposing to eliminate the requirement that a person requesting a change to the sex designation on a birth certificate present proof from a health professional.  Instead, applicants would be able to self-attest as to their gender.  Additionally, the Department is proposing that the Board approve “X” as an additional sex designation for persons who do not identify as exclusively female or male.

The Department, in discussion with other states and advocates, has found that having practitioners affirm or attest to a person applicant’s gender identity is both a potential barrier for persons without access to a practitioner and does not add sufficient value in the process of deciding whether a new birth certificate should be issued.  Anecdotal evidence suggests that practitioners simply comply with their patients’ requests when asked to affirm or attest to a patient’s request for a change of gender.  Consequently, the Department proposes to rely on the applicant’s attestation that would require notarization.

The Department is also proposing that the Board approve “X” as an additional sex designation option that is not exclusively female or male for birth certificate sex change requests.  The sex designation on the US Standard Certificate of Live Birth is completed by the hospital or attendant at the time of birth.  The four choices are male, female, unknown and undetermined.  These are “sex” categories and not gender categories. The original public health data reported by the hospital is not changed under this proposal.

“Gender” categories are only applied on the birth certificate during an amendment process.  When the gender on a birth certificate is amended the original record is placed under seal and a new record is created.  There is no indication on the record of the amendment history.  The Department is proposing to allow “X” for those applicants who want a designation other than female or male on their birth certificate.

Statement of Basis and Purpose

Section 274 of the federal Atomic Energy Act of 1954 [42 USC §2021 et seq.] (“Atomic Energy Act”) authorizes “Agreement States” to regulate byproduct material, source material and special nuclear material in quantities not sufficient to form a critical mass.  New York State is an “Agreement State” within the meaning of the Atomic Energy Act, and the New York City Department of Health and Mental Hygiene (“Department” or “DOHMH”) operates a component of the New York State Agreement.  Under this Agreement State structure, the DOHMH, through its Office of Radiological Health (“ORH”), regulates radioactive material for medical, research and academic purposes within the five boroughs of New York City.

New York State (NYS) Public Health Law §§225(5)(p) and (q) allows the NYS Commissioner of Health and the NYS Public Health and Planning Council to establish regulations with respect to ionizing radiation and nonionizing electromagnetic radiation and to authorize appropriate officers or agencies to register radiation installations, issue licenses for the transfer, receipt, possession and use of radioactive materials, other than special nuclear materials in quantities sufficient to form a critical mass, render such inspection and other radiation protection services as may be necessary in the interest of public health, safety and welfare. The NYS regulations are set out in Part 16 of the NYS Sanitary Code.

The Sanitary Code, in 10 NYCRR §16.1(b)(3), allows New York City to establish its own radiation licensure requirements in place of State regulations, so long as the local requirements are consistent with Sanitary Code requirements. 

New York City Charter (“Charter”) Section 556(c)(11) authorizes the Department to supervise and regulate the public health aspects of ionizing radiation, the handling and disposal of radioactive wastes, and the activities within the city affecting radioactive material.   

Background

Article 175 of the New York City Health Code (“Health Code”) applies to all radiation-producing equipment and radioactive material within NYC.  The Article contains general provisions applicable to both radiation equipment registrants and radioactive materials licensees, and specific requirements for such equipment and materials. The purpose of Article 175 is to protect the public, as well as workers in radiation installation facilities, from the potential hazards of ionizing radiation.  The Article’s requirements for radiation control reflects the coordination of radiation control activities with the U.S. Nuclear Regulatory Commission (“NRC”), the U.S. Food and Drug Administration, the NYS Department of Health and the NYS Department of Environmental Conservation, and other relevant city, state and federal agencies.  

The proposed reenacted Article 175 of the Health Code incorporates federal requirements contained in Title 10 of the Code of Federal Regulations (“CFR”) and reflects and is consistent with state regulations contained in the NYS Sanitary Code [10 NYCRR Part 16], and sets forth ORH-specific best practices requirements.   By law, the City must maintain compatibility with applicable federal requirements and consistency with applicable state regulations.  The Health Code may, and Article 175 as proposed does, in certain instances, mandate more stringent requirements as to health and safety radiation control measures than those required by federal and state authorities.

In NYC, there are about 6500 registered facilities with radiation-producing machines and 375 licensed sites with radioactive material for medical, academic and research purposes. Of the registered facilities, approximately 6440 are diagnostic X-ray facilities and 60 are therapeutic X-ray facilities. ORH inspects these facilities at varying frequencies depending on the type of usage.  Current inspection fees are unchanged under this proposed reenactment.

Radiation equipment

Prior to this rulemaking, Article 175 of the Health Code has not been substantially updated, particularly as to its radiation equipment requirements, since its last enactment in 1994.  Similar to that last reenactment, the Department has based much of this proposed reenacted text on the model code maintained by the Conference of Radiation Control Program Directors (CRCPD). The CRCPD is a 501(c)(3) nonprofit professional organization whose primary membership is made up of radiation professionals in state and local government that regulate the use of radiation sources in their jurisdictions.  CRCPD's mission is "to promote consistency in addressing and resolving radiation protection issues, to encourage high standards of quality in radiation protection programs, and to provide leadership in radiation safety and education".^[1]  Since the reenactment of Article 175 in 1994, improved best practices have been developed and implemented for radiation control measures.  Many of these measures are reflected in the current CRCPD model code, which has provided the basis for much of the text related to radiation equipment in the new proposed Article 175.

Radioactive materials

As noted above, Article 175 of the Health Code incorporates federal requirements from Title 10 of the CFR.  New York State is an Agreement State with the U.S. NRC which means that the NRC has delegated authority to NYS to regulate radioactive material at non-reactor sites within its jurisdiction.  The New York State Agreement is comprised of the regulatory programs of three agencies:

1. the New York State Department of Health,

2. the New York State Department of Environmental Conservation, and

3. the New York City Department of Health and Mental Hygiene.

Under the NYS Agreement and § 16.1 of the State Sanitary Code, 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.  Each Agreement State program is required to maintain compatibility with the NRC regulatory program. The NRC regulatory program utilizes Compatibility Categories to specify the type of wording to be used in the corresponding State program regulations.^[2]

As noted above, the last significant revision of Article 175 requirements occurred over 20 years ago.  Since then, NRC has made numerous updates of its requirements contained in Title 10 of the CFR.  In order for the Department to maintain its compatibility status with the NRC regulatory program, each time the NRC has updated its regulations in Title 10 of the CFR, the Board has had to make corresponding updates to Article 175, which has been an inefficient and time–consuming process.  In many instances, and because of the compatibility designations, the Board updated Article 175 by reproducing the actual CFR text directly into its requirements. The Board believes that continuing to update its rules this way is redundant and unnecessary and that it makes more sense to incorporate by reference the relevant CFR regulations, which will still provide the same legal force and effect as if the Board had actually reproduced such requirements directly into Article 175.  This incorporation by reference process avoids duplication and provides uniform, accurate guidance to the regulated community, as well as making for a less unwieldy and more manageable Code.

Accordingly, the Department proposes the Board repeal and reenact Article 175 primarily to:

• update the quality assurance requirements to reflect industry-wide best practices for the installation, operation and maintenance of  both diagnostic and therapeutic radiation equipment required to be registered with the Department, and which is used for medical, academic and research purposes, and

• more efficiently adopt and enforce NRC requirements for the possession and use of radioactive materials required to be licensed by the Department by incorporating by reference applicable federal regulations contained in Title 10 of the CFR for radioactive materials.

Statutory Authority

This repeal and reenactment of Article 175 of the Health Code is proposed pursuant to Sections 556, 558 and 1043 of the Charter and applicable state and federal law.  Section 556 of the Charter grants the Department jurisdiction to regulate matters affecting health in New York City.  Specifically, Section 556(c)(11) of the Charter authorizes the Department to supervise and regulate the public health 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.

Statement of Basis and Purpose 

Statutory Authority

These amendments to the Health Code are promulgated pursuant to §§ 558 and 1043 of the Charter. 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 authority of the Department of Health and Mental Hygiene (the “Department” or “DOHMH”) extends. 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. 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 use 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. In 2013, the Board of Health amended the Health Code to require hospitals to report when persons between the age of 18 and 30 are first admitted with a psychotic illness so that DOHMH can make appropriate linkages to services through the NYC Supportive Transition and Recovery Team (NYC START).  The Department of Health and Mental Hygiene has successfully implemented hospital reporting with time-limited linkage to care for individuals 18 – 30 years of age with a first-episode psychosis hospital admission. However, in order to best account for and intervene in episodes of early psychosis and address health disparities, it is necessary to expand the age criteria for the reporting requirement to those aged 16 and over, collect data on race and ethnicity, and retain collected information past the current 30 day time limit.

Current Linkages to Care for First-Episode Psychosis

When the Health Code was amended in 2013 to address inadequate linkages to care for people with first-episode psychosis, we pointed out that New Yorkers with psychotic illnesses often do not seek care or become disengaged from care in part due 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

While NYC START has improved these linkages to care for those who are reported with first-episode psychosis and accept services, we seek to further amend the Health Code to improve the health of all New Yorkers with first-episode psychosis. In particular, there are three areas that need to be addressed in order to more fully account for the needs of individuals with psychosis:

1. Currently, the Department may only retain identifiable information of individuals reported with first-episode psychosis for 30 days unless they accept care through NYC START, making psychosis the only reportable illness that places a limit on the amount of time the information can be seen by the Department. After 30 days, this information must be de-identified and cannot be used to follow up with the individual or to identify possible re-reporting. Given the many reasons that people with first-episode psychosis disengage from care, it is necessary to retain this information past 30 days to ensure that outreach can continue to those who have been unreachable during the initial 30-day period, to comprehensively assess the needs of communities, and to work with providers to develop successful interventions.
2. DOMMH estimates that approximately 2,000 new cases of psychotic illness develop each year in New York.[2]^,[3]  Our analysis of NYC hospital admissions found that 6 % of probable first-episode admissions occurred among persons between 16 and 17 years of age.[4]  There has been an expansion in the availability of specialized services for individuals 16 to 30 years of age.  However, due to restrictions in the Health Code limiting the reporting age to between 18 and 30, we do not currently account for individuals who develop first-episode psychosis before the age of 18. 
3. Race and ethnicity are currently not among the list of required information that hospitals must identify when making a report of first-episode psychosis. Because there are racial disparities in the diagnosis and treatment of psychotic disorders, however, this information is especially pertinent to collect and utilize to improve interventions and address health inequity.[5]

Proposed Rule

To improve interventions, linkages to care, and outcomes for New Yorkers experiencing first-episodes of psychosis, the Department proposes that the Board of Health amend Article 11 of the Health Code. The proposed changes would facilitate participation in early intervention services by requiring hospitals to report when individuals over 16 and under 31 years of age are admitted with a first-episode of psychotic illness. The proposed changes would further facilitate the creation of a database of reported cases of first-episode psychosis that would permit the Department to monitor trends of the illness.

Evaluating these trends can be used to:

• Develop targeted, culturally-competent interventions in the NYC START program
• Measure outcomes of first-episode psychosis care, and thereby direct more efficient interventions to health care institutions, health care providers and people with psychosis.

Reporting will continue to be required within 24 hours of admission and will include hospital name, patient name, age, gender, address, telephone, date of admission, insurance type, diagnosis, race, and ethnicity. All patient information reported to the Department will be kept confidential and will not be shared with anyone other than the patient or treating provider.