Md. Code Regs. 26.11.16.04 - Scientific Review and Amendment of Various Levels and Lists
A. Ongoing
Scientific Review.
(1) In order to use the
best available scientific information, the Department will conduct an ongoing
review of information concerning whether to add or delete toxic air pollutants
under Regulations .06 and .07 of this chapter and concerning what screening
levels or ambient concentrations should be used to review emissions of toxic
air pollutants. In its ongoing review, the Department will consider scientific
information developed by the U.S. Environmental Protection Agency, other
states, or other scientific organizations. The Department will also consider
scientific information provided by any person.
(2) In reviewing information about toxic air
pollutants or requests to amend lists, screening levels, or ambient
concentrations, the Department will request advice from the Governor's Science
Advisory Council.
B.
Interim Levels Set During Permit Review.
(1)
Requesting Approval.
(a) In order to
demonstrate compliance with COMAR
26.11.15.06 a when scientific
evidence indicates a screening level adopted under this chapter should be
revised, a person may request Departmental approval of an interim special
screening level, interim AAL, or interim IRC for a TAP. The person shall submit
written information on the health effects of the TAP, the levels at which
health effects have occurred, and other supporting information requested by the
Department.
(b) The Department may
use an interim special screening level, interim AAL, or interim IRC, to
establish allowable emissions of a TAP for a source until a special screening
level, AAL, or IRC for the TAP has been adopted or amended under this
chapter.
(2) Scientific
and Public Review.
(a) In order to evaluate
information concerning a proposed interim special screening level, an interim
AAL, or interim IRC, the Department may convene a scientific review panel
consisting of scientific experts from within or outside the
Department.
(b) If the Department
makes a determination to proceed with an interim special screening level,
interim AAL, or interim IRC, it will notify the applicant. The applicant shall
publish a notice of an opportunity for a public hearing on the interim special
screening level, interim AAL, or interim IRC, using the procedures set forth at
COMAR 26.11.02.12 a F, G for providing
public notice and an opportunity for public hearing.
(c) If the Department is required or intends
to provide an opportunity for a public hearing on a permit or approval for the
source in question, the opportunity for a public hearing on the interim special
screening level, interim AAL, or interim IRC, may be provided
concurrently.
(3)
Approval Criteria. The Department will approve an interim special screening
level, interim AAL, or interim IRC, only if it meets the approval criteria
listed under §D of this regulation.
C. Petitions.
(1) Filing. In accordance with COMAR
26.01.03, any interested person may file a petition asking the Department to
adopt or amend a special screening level, acceptable ambient level, or
insignificant risk concentration for a TAP. The petitioner should submit
information on the health effects expected to be caused by the TAP, the levels
at which health effects occur, other information that supports adopting or
changing a screening level, acceptable ambient level, or insignificant risk
concentration.
(2) Scientific
Review. In order to evaluate information submitted by a petitioner, the
Department may convene a scientific review panel consisting of scientific
experts from within or outside the Department.
D. Approval Criteria.
(1) Special Screening Level. The Department
will adopt a special screening level only if it determines that the level will
not unreasonably endanger human health and provides a scientifically
appropriate basis for screening analysis. In deciding whether to establish a
special screening level for a TAP, the Department will consider the scientific
basis for both the special screening level and any applicable TLV as well as
other available information on the health effects of the TAP.
(2) Acceptable Ambient Level. The Department
will adopt an AAL under this chapter only if the Department determines that
concentrations at that level will provide a margin of safety to protect the
public health from toxic effects of the TAP other than cancer.
(3) Insignificant Risk Concentration.
(a) The Department will adopt an IRC under
this chapter only if the Department determines the IRC is calculated using
procedures consistent with EPA's Risk Assessment Guidelines and is the annual
average concentration, in micrograms per cubic meter, that would increase a
person's lifetime cancer risk by not more than 1 in 100,000 (1 x
10-5th) if the person were continuously exposed to
the concentration for 70 years.
(b)
In deciding whether to adopt an IRC, the Department will consider factors
contributing to the uncertainty of the applicable upper bound unit risk factor,
including:
(i) Whether it is appropriate to
use a most likely estimate of risk rather than a 95 percent upper confidence
limit in developing an IRC;
(ii)
Whether the IRC should be based on the highest unit risk factor developed from
the most sensitive species; and
(iii) Other pertinent information.
Notes
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