Non-clinical Laboratories Rules (Article 13 of the New York City Health Code)

Proposed Rules: Closed to Comments

Agency:
Comment By: 
Tuesday, April 26, 2016
Download Copy of Proposed Rule (.pdf): 
 

Statement of Basis and Purpose

 

Background

 

The Charter provides the Department of Health and Mental Hygiene (the Department) with jurisdiction over all matters concerning health in the City of New York.  The Department conducts disease surveillance and control activities for diseases reportable pursuant to Article 11 of the New York City Health Code (Health Code).  The Department is also required to comply with various provisions of Part 2 of the New York State 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.

 

“High containment research laboratories” are facilities that store and handle infectious microorganisms or hazardous biological material and operate at biosafety level (BSL) 3 or 4, as defined by the US Centers for Disease Control and Prevention (CDC) and National Institutes for Health (NIH), in Biosafety in Microbiological and Biomedical Laboratories (BMBL), which delineates four BSLs based on the potential risks of working with infectious or hazardous agents.

 

Biosafety level 1 (BSL-1) is the basic level of protection and is appropriate for agents that are not known to cause disease in normal, healthy humans. Biosafety level 2 (BSL-2) is appropriate for handling moderate-risk agents that cause human disease of varying severity by ingestion or through percutaneous or mucous membrane exposure. Biosafety level 3 (BSL-3) is appropriate for agents with a known potential for aerosol transmission, for agents that may cause serious and potentially lethal infections and that are indigenous or exotic in origin. Exotic agents that pose a high individual risk of life-threatening disease by infectious aerosols and for which no treatment is available are restricted to high containment laboratories that meet biosafety level 4 (BSL-4) standards.[1]   

 

  Since 2001, hundreds of new high-containment research laboratories have been established in the United States. According to the U.S. Government Accountability Office (GAO), 1,495 BSL-3 and BSL-4 laboratories were registered with the Federal Select Agent Program (FSAP) in 2010 compared to 415 in 2004. This was considered an under-estimate, because it only addressed laboratories required to register with the FSAP.[2] With respect to those operating in New York City, the Department does not know when such facilities were or are being established, the total number operating in the City at any time, and the hazardous agents they store or handle.

 

Recent laboratory accidents, none of which occurred in New York City, have focused the Department’s attention on this issue. In June and July 2014, CDC disclosed two potentially serious incidents involving H5N1 avian influenza[3] and Bacillus anthracis,[4] the bacterium that causes anthrax. A third incident at CDC involving an Ebola virus sample occurred in December 2014.[5] In 2007, another potentially serious incident occurred at CDC when the main and backup power supplies failed during a lightning storm, shutting down the negative pressure system in a newly constructed, but not yet operational, BSL-4 laboratory.[6]

 

Two incidents in the past two years involving high-containment laboratories further demonstrate the potential public health risks stemming from research conducted in BSL-3 and BSL-4 laboratories. In November 2014, two primates in the Tulane National Primate Research Center were diagnosed with melioidosis, a severe disease of animals and humans caused by a potential biological threat agent, Burkholderia pseudomallei. The strain infecting the animals was identical to the strain used in a Tulane University laboratory registered with the FSAP. In March 2015, CDC and the U.S. Department of Agriculture’s (USDA) Animal Plant Health Inspection Service (APHIS) concluded that a number of biosafety deficiencies could have led to transmission of B. pseudomallei from the laboratory to the animals in the primate center.[7]

 

In May 2015, CDC started an investigation of a report that a U.S. Department of Defense high-containment laboratory might have inadvertently shipped live B. anthracis spores (the causative agent of anthrax) to a laboratory that was anticipating only deactivated spores. Ultimately, CDC concluded that this laboratory unknowingly shipped live B. anthracis spores on 575 separate occasions to laboratories worldwide over the course of a decade.[8]

 

As serious as these incidents have been, of even greater concern have been laboratory incidents over past decades that have caused outbreaks of contagious virus diseases, including smallpox, SARS, and foot and mouth disease.[9] The Department is concerned that an accident in a NYC-based high-containment research laboratory could have catastrophic consequences, given the population density of nearly 70,000 per square mile in Manhattan and the many other areas of high population density throughout the City.

 

Work performed in a BSL-3 or BSL-4 facility would present the greatest potential risk to public health if an incident occurs. Research laboratories that handle biological agents and toxins and hold government contracts or grants are required to adhere to the BMBL. Most, but not all, of the agents that are stored and handled in high-containment research laboratories and that represent potential public health risks are regulated by the FSAP. Federal regulations require reporting of certain incidents involving select agents to the CDC and local, state and federal law enforcement agencies only; timely notification to local public health authorities of these incidents is not always required by the federal regulations. Federal agencies are also constrained from disclosing to local or state health departments which laboratories within a local jurisdiction are registered to handle and work with select agents. The Department has been informed by the CDC that, with the proper safeguards, information identifying the registered laboratories can be made available to the Department.  However, no other information about these laboratories or the biological agents they work with would be regularly available from CDC.  

 

Several federal agencies exercise varying degrees of oversight over academic and private high-containment research laboratories.  CDC and USDA APHIS regulate laboratories working with certain biological agents and toxins that have the potential to pose a severe threat to public health and safety, known as “select agents,” pursuant to 42 CFR Part 73 (CDC regulations), and 9 CFR Part 121 and 7 CFR Part 331 (USDA regulations).

 

According to the GAO, “While some federal agencies do have a mission to track a subset of BSL-3 and -4 laboratories that work with select agents and know the number of those laboratories, no single regulatory agency has specific responsibility for biosafety in all high-containment laboratories in the United States.”6 If a laboratory is not working with a select agent or not operating with government funding or under a government contract, it is not bound by the federal regulatory scheme, and, unless there is applicable state or local law, a laboratory may be totally unregulated.

 

Because of this regulatory structure, the Department does not have a means to know the number of high-containment research laboratories operating in New York City, their location, or the potentially hazardous biological agents that are stored and/or handled within them. Although clinical laboratories hold permits issued by the State Department of Health,[10] non-clinical research laboratories storing and/or handling biological agents are not currently regulated by the City or State.  They do not currently need to hold permits, to notify local authorities of their existence, or to report incidents of public health concern to the Department, such as loss or theft of agents or suspected transmission of diseases caused by agents stored and/or handled in the laboratories. Unless high-containment research laboratories are required to register with the Department, pre-event planning between the Department and laboratories to mitigate the public health risks and to protect public health cannot take place.      

 

Several state and local US jurisdictions currently regulate research laboratories working with biological agents. In 1996, Connecticut, which had already required all laboratories to register and be inspected before conducting any examination, determination, or test, enacted additional reporting requirements specifically applicable to BSL-3 laboratories, requiring reporting of any infection or injury relating to work with such agents or resulting in recommendations that employees or members of the public be tested or monitored for potential public health problems.[11] Since 2002, Maryland has had a Biological Agent Registration Program, which is nearly identical to the FSAP. The Boston Public Health Commission adopted its Biological Laboratory Regulations in 2006. These regulations establish operational biosafety requirements and require permitting, inspections and reporting of human exposures and other incidents to the Commission.  In 2009, Cambridge, Massachusetts adopted biosafety laboratory regulations and formed the Cambridge Biosafety Committee to enforce them. 

 

The Department proposes that the Board amend Article 13 to require registration of and reporting by research laboratories that have BSL-3 and BSL-4 facilities. A registration form will require identification and contact information of owners, operators, and other persons responsible for biosafety and a list of the biological agents stored and/or handled onsite. The amendment will also require immediate reporting by such facilities to the Department of any exposures of persons, losses, thefts, or unintentional releases of such agents so that the Department can, if necessary, investigate and limit public health risks from these agents.  Laboratories that are currently operating solely as clinical laboratories, blood and tissue banks and those that conduct recombinant DNA experiments pursuant to Title 5 of Article 5, or Articles 43-B or 32-A, of the New York Public Health Law would be excluded from these registration and reporting requirements.

 

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 to amend the Health Code and to include in the Health Code all matters to which the authority of the Department extends. Section 1043 grants the Department rule-making authority.  Section 556(c)(2) of the Charter authorizes the Department to “supervise the reporting and control of communicable and chronic disease and conditions hazardous to life and health…”

The proposal is as follows:

“Shall” and “must” denote mandatory requirements and may be used interchangeably unless otherwise specified or unless the context clearly indicates otherwise.

 


[1] CDC (US) and NIH (US). Biosafety in Microbiological and Biomedical Laboratories. 5th ed. Washington (DC): Centers for Disease Control and Prevention (US) and National Institutes of Health (US). 2007; 409 p. Available from http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf

[2] GAO (US). High-Containment Laboratories: Assessment of the Nation’s Need is Missing. Washington (DC): Government Accountability Office (US). 2013 Feb 25; 13 p. Report No.: GAO-13-466R. Available from http://www.gao.gov/products/GAO-13-466R

[3] CDC (US). Report on the Inadvertent Cross-Contamination and Shipment of a Laboratory Specimen with Influenza Virus H5N1. 2014 August 15. http://www.cdc.gov/about/pdf/lab-safety/investigationcdch5n1contaminatio...

[4] CDC (US). Report on the Potential Exposure to Anthrax. 2014 July 11. http://www.cdc.gov/about/pdf/lab-safety/Final_Anthrax_Report.pdf

[5] CDC (US). Report on the Potential Exposure to Ebola Virus. 2015 February 4. http://www.cdc.gov/about/pdf/lab-safety/investigation-into-dec-22-2014-c...

[6] Government Accountability Office (US). High Containment Laboratories—National Strategy for Oversight is Needed. Washington (DC):  Government Accountability Office (US); 2009 Sep. 99 p. Report No.: GAO-09-574. Available from http://www.gao.gov/products/GAO-09-574

[7] CDC (US). Conclusion of select agent inquiry into Burkholderia pseudomallei release at Tulane National Primate Research Center. 2015 Mar 13. Available from http://www.cdc.gov/media/releases/2015/s0313-burkholderia-pseudomallei.html

[8] HHS (US). Testimony of Daniel M. Sosin, MD, MPH, FACP, before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives. Review of Department of Defense Anthrax Specimens. 2015 Jul 28. Available from http://docs.house.gov/meetings/IF/IF02/20150728/103816/HHRG-114-IF02-Wst...

[9] Furmanski M. Threatened pandemics and laboratory escapes: self-fulfilling prophecies. Bulletin of the Atomic Scientists. 2014 Mar 31. Available from http://thebulletin.org/threatened-pandemics-and-laboratory-escapes-self-...

[10] See, e.g., New York Public Health Law Article 5-Laboratories.

[11] Conn. Gen. Stat. §19a-31a; Conn. Agencies Regs. §§ 19a-36-A1 to A56.

 

 

Public Hearing
Subject: 

Proposed resolution to amend Article 13(Laboratories) of the New York City Health Code, regarding non-clinical laboratories.

Public Hearing Date: 
Tuesday, April 26, 2016 -
9:30am to 11:30am
Contact: 

Svetlana Burdeynik at ph: (347) 396-6078 or resolutioncomments@health.nyc.gov

Location: 
New York City Department of Health and Mental Hygiene, Gotham Center
42-09 28th Street 14th Floor, Room 3-32
Queens, NY 11101