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10.10.11.00.htm 10.10.11.00. Title 10 MARYLAND DEPARTMENT OF HEALTH Subtitle 10 LABORATORIES Chapter 11 Biological Agents Registry Program Authority: Health-General Article, §17-601―17-605, Annotated Code of Maryland
10.10.11.01.htm 10.10.11.01. 01 Purpose.. The purpose of this chapter is to help protect the people of Maryland against the potential threat of biological terrorism by establishing a program to register persons that possess, maintain, transfer, or receive biological agents in the State.
10.10.11.02.htm 10.10.11.02. 02 Scope.. A. This chapter contains the standards and requirements a person that possesses, maintains, transfers, or receives a biological agent in this State shall meet to comply with the registration of biological agents.B. This chapter does not apply to a biological agent or a certified laboratory or facility that is exempt from the requirements for the interstate shipment of etiologic agents under 42 CFR §73.5 and 73.6, 9 CFR §121.5 and 121.6, and 7 CFR §331.5.
10.10.11.03.htm 10.10.11.03. 03 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) "Access" means the ability or the means necessary to:. a) Read, write, modify, or communicate BAR information; or. b) Otherwise make use of any system resource related to BAR information.. 2) "Access control" means a method of restricting access to a BAR information resource, allowing only an authorized individual access to the resource.
10.10.11.04.htm 10.10.11.04. 04 Incorporation by Reference.. A. In this chapter, the following documents are incorporated by reference.. B. Documents Incorporated.. 1) 29 CFR §1910.1450, as amended.. 2) 42 CFR 73, as amended.. 3) 9 CFR 121, as amended.. 4) 7 CFR 331, as amended.. 5) CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories” 5th Edition, December 2009.
10.10.11.05.htm 10.10.11.05. 05 Registering Under the Biological Agents Registry Program.. A person in the State shall participate in and comply with the State's BAR Program by registering with and reporting to the Department, in the manner set forth in this chapter, the information required by the Department.
10.10.11.06.htm 10.10.11.06. 06 Compliance with Federal Standards.. A person that possesses, maintains, transfers, or receives a biological agent shall comply with all safeguards contained in 42 CFR 73, 9 CFR 121, and 7 CFR 331 that apply to a person registered to transfer the same agent under federal law and regulation.
10.10.11.07.htm 10.10.11.07. 07 Responsibilities of the Department.. The Department shall:. A. Establish and maintain a registry that identifies the biological agents possessed, maintained, transferred, and received by a person in this State;B. Conduct facility surveys by mail, by on-site visit, or both, initially and periodically after that, to:1) Ensure compliance with the standards and requirements of the BAR Program; and. 2) Address any deficiencies or complaints;. C. Provide or approve the
10.10.11.08.htm 10.10.11.08. 08 Responsible Official; Alternate Responsible Official.. A. A person required to report to the BAR Program under this chapter shall designate an individual to be the responsible official who:1) Is familiar with the requirements of this chapter;. 2) Has the authority and responsibility to act on the person's behalf related to a biological agent; and3) Shall ensure compliance with the requirements of this chapter.. B. The responsible person shall ensure that the an
10.10.11.09.htm 10.10.11.09. 09 Reporting Requirements.. A. What to Report. Using reporting forms provided or approved by the Department, a person shall:. 1) Identify all non-exempt biological agents that the person possesses, maintains, transfers, or receives listed under:a) Select agents and toxins in:. i) 42 CFR §73.3;. ii) 9 CFR §121.3; and. iii) 7 CFR §331.3; and. b) Overlap select agents and toxins in:. i) 42 CFR §73.4; and. 2) Indicate as part of the identification if a biological agent is:.
10.10.11.10.htm 10.10.11.10. 10 Additional Requirements Covering Possession, Maintenance, Transfer, or Receipt of a Biological Agent.A person possessing, maintaining, transferring, or receiving a biological agent at a facility located in the State shall:A. Possess a laboratory and personnel equipped and capable of handling the biological agents at BSL 2, 3, or 4, depending on the agent and the type of work being performed with the agent, as contained in the BMBL;B. Meet specific requirem
10.10.11.11.htm 10.10.11.11. 11 Reporting of Unauthorized Activities.. On learning that there is an unauthorized activity involving a biological agent, including the unauthorized possession, unauthorized attempted possession, unauthorized maintenance, unauthorized transfer, or unauthorized receipt of a biological agent, a person shall immediately alert the Department by:A. Telephoning the:. 1) Laboratories Administration at 410-767-6100 between 8 a.m. and 4:30 p.m. weekdays; or. 2) Department's emergency
10.10.11.12.htm 10.10.11.12. 12 Biological Agent Incident Response Plan.. A. Requirement. A person required to report under this chapter shall:. 1) Develop, implement, and maintain a written biological agent incident response plan;. 2) Review the plan annually and revise the plan as necessary; and. 3) Submit a copy of the plan and any amendments to the plan to the:. a) Emergency management director in the local jurisdiction where the biological agent is located; andb) BAR Program..
10.10.11.13.htm 10.10.11.13. 13 BAR Information Confidentiality and Release of BAR Information.. A. Except as otherwise provided in this chapter, a person shall keep information prepared for or maintained in the BAR, including biological agent incident response plans required by Regulation .12 of this chapter:1) Confidential; and. 2) Protected from unauthorized access and use.. B. BAR information is not subject to State Government Article, Title 10, Subtitle 6, Annotated Code C. Release or sharing of
10.10.11.14.htm 10.10.11.14. 14 Method of Non-Emergency Release of BAR Information.. A. A person shall release and transfer BAR information to a trusted partner and a BAR information custodian in a secure manner, which includes the use of:1) Read-only optical or electronic media;. 2) Encryption and decryption; and. 3) Copy protection to prevent unauthorized copying or duplication.. B. Unless authorized or required by federal regulation as set forth in Regulation .04B(2)4) of this chapter and except as pro
10.10.11.15.htm 10.10.11.15. 15 Release of BAR Information to Law Enforcement Agencies and CDC.. The BAR Program may release BAR information to State and federal law enforcement agencies and the CDC without a trusted partner agreement if the release of BAR information is pursuant to:A. A communicable disease investigation commenced or conducted by:. 1) The Department; or. 2) A State or federal law enforcement agency having investigative authority; or.
10.10.11.16.htm 10.10.11.16. 16 Release of BAR Information to Local Jurisdictions.. A. The Department shall release to a local jurisdiction the BAR information listed in §C of this regulation for each biological agent located within the local jurisdiction, if the local jurisdiction:1) Enters into and maintains a trusted partner agreement with the Department; and. 2) Limits the number of BAR information custodians in the local jurisdiction to the:. a) Health officer or the health officer’s designee; and.
10.10.11.17.htm 10.10.11.17. 17 Release of BAR Information to MDE, MEMA, and MIEMSS.. The Department shall:. A. Release separately to the BAR information custodians of MDE, MEMA, and MIEMSS the BAR information listed in §C of this regulation for each biological agent located within the State, if MDE, MEMA, and MIEMSS each separately becomes a trusted partner by:1) Entering and maintaining a trusted partner agreement with the Department; and. 2) Authorizing and identifying the individual who
10.10.11.18.htm 10.10.11.18. 18 BAR Information Updates.. The Department shall provide updated BAR information to the BAR information custodians of all trusted partners authorized under this chapter:A. Within 30 days when there is an:. 1) Upward change in the BSL at a listed person's facility, for example from BSL-3 to BSL-4; or. 2) Addition to the BAR, including a new:. a) Person possessing or maintaining a biological agent;. b) Facility where a biological agent is located; or. c) Biological agent; and.
10.10.11.19.htm 10.10.11.19. 19 BAR Information Security Standards ― General.. A. A trusted partner shall protect and maintain BAR information in a secure manner by limiting access only to a BAR information custodian who is:1) An individual designated by the trusted partner; and. 2) Authorized by the Department in a trusted partner agreement.. B. Before the Department shares BAR information with a trusted partner, the trusted partner shall:. 1) Develop, implement, and maintain administrative
10.10.11.20.htm 10.10.11.20. 20 BAR Information Security Standards ― Administrative Procedures.. A trusted partner shall establish and maintain administrative procedures to protect BAR information integrity, confidentiality, and availability, which include:A. Entering and maintaining with the Department a trusted partner agreement that certifies that the trusted partner shall:1) Establish and implement the policies and procedures to carry out the requirements of this chapter; and
10.10.11.21.htm 10.10.11.21. 21 BAR Information Security ― Physical Safeguards.. A trusted partner shall establish physical safeguards to guard BAR information integrity, confidentiality, and availability, which include:A. Physical protection of the personal computer system used for viewing BAR information and related buildings and equipment from:1) Fire;. 2) Natural and environmental hazards;. 3) Disasters; and. 4) Intrusion;. B. A secure work station location with physical safeguards to eliminate or
10.10.11.22.htm 10.10.11.22. 22 BAR Information Security ― Technical Security Measures.. A trusted partner shall establish a system of technical security measures to protect BAR information integrity, confidentiality, and availability, which include:A. A BAR information security assessment to determine the sensitivity, vulnerabilities, and security of the trusted partner's programs and operations related to the BAR information the trusted partner:1) Receives;. 2) Views;. 3) Manipulates;. 5) Transmits;.
10.10.11.23.htm 10.10.11.23. 23 Trusted Partner Agreement.. A. Requirement. The Department may not share BAR information with a person until the person becomes a trusted partner by entering into a trusted partner agreement, using the form developed by the Department.B. The Department shall develop and use a trusted partner form that contains, as applicable, separate clauses that:1) Establish the length of time that the trusted partner agreement is in effect;. 2) Address that confidentiality will survive the t
10.10.11.24.htm 10.10.11.24. 24 Penalties.. A. Fine. A person who violates a provision of Health-General Article, Title 17, Subtitle 6, Annotated Code of Maryland, or this chapter is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $100 for the first offense and not exceeding $500 for each subsequent conviction for a violation of the same provision.B. Subsequent Offense. Each day a violation is continued after the first conviction is a subsequent offense.
10.10.11.9999.htm 10.10.11.9999. Administrative History Effective date: November 25, 2002 (29:23 Md. R. 1811) ―. Chapter revised effective July 31, 2006 (33:15 Md. R. 1280) ―. Chapter revised effective January 23, 2012 (39:1 Md. R. 17).
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