Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.11 - Biological Agents Registry Program
Section 10.10.11.03 - Definitions
Universal Citation: MD Code Reg 10.10.11.03
Current through Register Vol. 51, No. 19, September 20, 2024
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.
(3) "Authentication" means the corroboration
that a person is the one claimed.
(4) "BAR" means the Department's Biological
Agents Registry.
(5) BAR
Information.
(a) "BAR information" means
information submitted to the BAR Program by a person required to report a
biological agent under this chapter.
(b) "BAR information" identifies:
(i) A person in this State who possesses,
maintains, transfers, or receives a biological agent; and
(ii) The biological agents possessed,
maintained, transferred, and received by a person in this State.
(c) "BAR information" includes:
(i) Information contained in any of the
documents and records that the BAR Program collects, requests, maintains,
processes, or stores;
(ii)
Information released by the BAR Program, a trusted partner, or a BAR
information custodian; and
(iii)
Biological agent incident response plans submitted to a local jurisdiction as
required by this chapter.
(6) BAR Information Custodian.
(a) "BAR information custodian" means an
individual designated by a trusted partner and authorized by the Department in
a trusted partner agreement to receive and maintain BAR information.
(b) "BAR information custodian" may include:
(i) A health officer or designee;
(ii) An Emergency Management Director or
designee; and
(iii) Other
alternately designated and authorized individuals with a legitimate need to
know the BAR information as it relates to the performance of the person's
duties.
(7)
"BAR Program" means the Department's BAR Program within the Laboratories
Administration's Office of Laboratory Emergency Preparedness and
Response.
(8) "Biological agent"
means:
(a) A select agent or toxin listed in
42 CFR §§ 73.3 and
73.4,
7 CFR § 331.3, and
9 CFR §§ 121.3 and
121.4;
(b) A genetically modified microorganism or
genetic element from an organism listed in
42 CFR §§ 73.3 and
73.4,
7 CFR § 331.3, and
9 CFR §§ 121.3 and
121.4, shown to produce or encode
for a factor associated with disease; or
(c) A genetically modified microorganism or
genetic element that contains nucleic acid sequences coding for a toxin listed
in 42 CFR §§ 73.3 and
73.4, and
9 CFR §§ 121.3 and
121.4, or the toxin's
subunits.
(9) Biological
Agent Incident.
(a) "Biological agent
incident" means a breach of containment or imminent threat of a breach of
containment of a biological agent that poses an immediate threat to an
individual's health and safety.
(b)
"Biological agent incident" includes any situation that may cause or
potentially cause an exposure to or release of a biological agent, as set forth
in Regulation .12B of this chapter.
(10) "Biosafety Level (BSL)" means the level
of work practices, facility design, and safety equipment to prevent
transmission of biologic agents to workers, other individuals, and the
environment, as defined in the BMBL.
(11) "Biosafety Level-2 (BSL-2)" means the
BSL used when:
(a) Work is done with
biological agents associated with human disease; and
(b) The route of transmission is by:
(i) Percutaneous injury;
(ii) Ingestion; or
(iii) Mucous membrane exposure.
(12) "Biosafety Level-3
(BSL-3)" means the BSL used when:
(a) Work is
done with indigenous or exotic agents associated with a potentially serious or
lethal human disease; and
(b) The
route of transmission is aerosol inhalation.
(13) Biosafety Level-4 (BSL-4).
(a) "BSL-4" means the BSL used when work is
done with a dangerous and exotic biological agent that poses a high risk of
life-threatening or lethal human disease that:
(i) May be transmitted via the aerosol
route;
(ii) Has an unknown mode of
transmission; or
(iii) Has no
available vaccine or therapy.
(b) "BSL-4" includes the BSL used when the
agent has a close or identical antigenic relationship to BSL-4
agents.
(14) "BMBL" means
the "Biosafety in Microbiological and Biomedical Laboratories", which is
incorporated by reference in Regulation .04 of this chapter.
(15) "Centers for Disease Control and
Prevention (CDC)" means the federal Centers for Disease Control and Prevention
of the federal Department of Health and Human Services.
(16) "Compact Disc-Recordable (CD-R)" means a
type of write once, read many compact disc format that allows one-time
recording of digital information on the disc.
(17) Contingency Plan.
(a) "Contingency plan" means a plan for
responding to an information system emergency.
(b) "Contingency plan" includes:
(i) Installing system information from
backups;
(ii) Preparing critical
facilities that can be used to facilitate continuity of operations in the event
of an emergency; and
(iii)
Recovering from a disaster.
(18) "Decryption" means reversing the
protective encryption algorithm process to make the previously unintelligible
plaintext available for further processing as intelligible plaintext.
(19) "Deficiency" means a documented lack of
compliance with a standard or requirement of the BAR Program set forth in this
chapter.
(20) "Department" means
the Department of Health and Mental Hygiene.
(21) "Emergency management director" means an
individual appointed by the Governor of Maryland, who is directly responsible
for the organization, administration, and operation of the local organization
for emergency management in the local jurisdiction as set forth in Public
Safety Article, §14-109, Annotated Code
of Maryland.
(22) Encryption.
(a) "Encryption" means transforming
confidential plaintext into ciphertext to protect it so that the data can be
securely stored.
(b) "Encryption"
includes encrypting with an algorithm that combines plaintext with other values
called keys, or ciphers, so the data becomes unintelligible.
(23) "Etiologic" means disease
causing.
(24) "Exposure" means the
condition of being subjected to a biological agent which may have a harmful
effect.
(25) "Facility" means a
building or complex of buildings owned by the same person and located at a
single mailing address.
(26)
"Genetic element" means a nucleic acid sequence shown to produce or encode for
a factor associated with a disease, a toxin, or a toxin's subunits.
(27) "Local jurisdiction" means a county of
the State or Baltimore City.
(28)
"Maintaining a biological agent" means manipulating or holding a biological
agent to sustain or enhance viability, infectivity, or toxicity.
(29) "Maryland Institute for Emergency
Medical Services Systems (MIEMSS)" means the unit established by Education
Article, §13-503, Annotated Code of
Maryland.
(30) "MDE" means the
Maryland Department of the Environment.
(31) "MEMA" means the Maryland Emergency
Management Agency.
(32) Nature of
a Biological Agent.
(a) "Nature of a
biological agent" means the term that describes the kind or type of material or
organism the agent is.
(b) "Nature
of a biological agent" includes:
(i)
Toxin;
(ii) Bacterium;
(iii) Virus;
(iv) Rickettsia;
(v) Fungus;
(vi) Allergen;
(vii) Genetic element; or
(viii) Any combination of
(c) "Nature of a biological agent" does not
include the name or identity of the biological agent.
(33) Person.
(a) "Person" means an individual, receiver,
trustee, guardian, personal representative, fiduciary, or representative of any
kind and any partnership, firm, association, corporation, or other
entity.
(b) "Person" includes State
and federal units of government.
(34) "Personal identification number (PIN)"
means a number or code assigned to an individual and used to provide
verification of identity.
(35)
"Personal protective equipment (PPE)" means the type of physical barrier
equipment necessary to:
(a) Protect an
individual from contact with a biological agent; or
(b) Prevent transmission of a biological
agent.
(36) "Possessing a
biological agent" means handling, holding, maintaining, owning, or storing a
biological agent within the State.
(37) Responsible Official.
(a) "Responsible official" means an
individual designated by a person required to report under this chapter to act
on the person's behalf.
(b)
"Responsible official" includes an individual designated as an alternate
responsible official who acts in the responsible official's absence.
(38) "Role-based access" means a
security mechanism for granting user access to a computer information system
containing BAR information, based upon the user's job function.
(39) "Secretary" means the Secretary of
Health.
(40) "Security incident"
means a situation when BAR information is:
(a)
Intentionally or unintentionally released to an unauthorized person;
or
(b) Otherwise compromised in a
way that allows unauthorized access.
(41) Security Self-Assessment.
(a) "Security self-assessment" means a
person's formal assessment of the sensitivity, vulnerabilities, and security of
the person's operations and programs related to the BAR information the person
receives, manipulates, stores, or transmits.
(b) "Security self-assessment" includes the:
(i) Procedures and processes for determining
a person's compliance with the BAR information security standards in this
chapter;
(ii) Documentation
certifying to the BAR Program that a person meets the BAR information security
standards;
(iii) Identification and
management of security risks; and
(iv) Security standards self-assessment check
list provided by the BAR Program.
(42) "Technical security measure" means a
process that is put in place to protect information and control individual
access to information in order to guard data integrity, confidentiality, and
availability.
(43) "Token" means an
electronic device for authenticating user identification and allowing access to
a door or computer information system.
(44) Toxin.
(a) "Toxin" means a biologically active
poisonous substance that is:
(i) Produced by a
living cell or an organism; and
(ii) Harmful to another organism.
(b) "Toxin" does not include:
(i) A poisonous substance produced by a
living organism for medical purposes, inactivated for use as a vaccine;
or
(ii) A toxin preparation for
biomedical research use at a lethal dose of 50 percent (LD50) for vertebrates
of more than 100 nanograms per kilogram body weight.
(45) "Transfer" means the physical
relocation of a biological agent from one facility or person to
another.
(46) Trusted Partner.
(a) "Trusted partner" means a person with
whom the Department has a valid trusted partner agreement to receive, possess,
maintain, and transfer or share BAR information, as set forth in this
chapter.
(b) "Trusted partner"
includes only MDE, MEMA, MIEMSS, and a local jurisdiction where a biological
agent is located.
(47)
Trusted Partner Agreement.
(a) "Trusted
partner agreement" means a document describing the arrangement between the
Department and a trusted partner regarding how, when, and to whom information
is released from the BAR.
(b)
"Trusted partner agreement" includes the documentation that describes all the
policies, procedures, and mechanisms agreed upon to protect the integrity,
confidentiality, and availability of BAR information.
(48) "User-based access" means a security
mechanism used to grant system access to users, based upon the identity of the
user.
Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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