[Federal Register Volume 64, Number 120 (Wednesday, June 23, 1999)]
[Proposed Rules]
[Pages 33453-33455]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15981]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 63
[Docket No. A-99-03; FRL-6364-8]
Hazardous Air Pollutants List
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of receipt of a complete petition to delist methyl ethyl
ketone from the list of Hazardous Air Pollutants (HAPs).
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SUMMARY: This notice announces the receipt of a complete petition from
the Chemical Manufacturers Association's (CMA'S) Ketone Panel
requesting EPA to remove the chemical methyl ethyl ketone (MEK, 2-
Butanone) (CAS No. 78-93-3) from the list of hazardous air pollutants
(HAPs) contained in section 112(b)(1) of the 1990 Clean Air Act (Act).
We have determined that the Chemical Manufacturers Association's
original petition dated November 27, 1996 and the supplemental
materials provided by CMA through August 31, 1998 will support an
assessment of the human health impacts associated with people living in
the vicinity of facilities emitting methyl ethyl ketone. In addition,
the data submitted by CMA will support an assessment of the
environmental impacts associated with emissions of methyl ethyl ketone
to the ambient air and deposited onto soil or water. Consequently, we
have concluded that CMA's petition is complete as of August 31, 1998,
the date of the last supplement, and is ready for public comment and
the technical review phase of our delisting procedure.
This notice invites the public to comment on the petition and to
provide additional data, beyond that filed in the petition, on sources,
emissions, exposure, health effects and environmental impacts
associated with methyl ethyl ketone that may be relevant to our
technical review.
DATES: Written comments on this proposal must be received by July 23,
1999.
ADDRESSES: Documents. A copy of the complete petition is contained in a
docket available at the Air and Radiation Docket and Information
Office, 401 M Street S.W., Room M-1500 (Mail Code 6102), Waterside
Mall, Washington DC 20460. The docket number for this action is A-99-
03. The docket is an organized file of all the information received and
considered in making the decision on the completeness of CMA's
petition. The main purpose of the docket is to allow you to readily
identify and locate documents that record the process we followed in
making our decision. You may inspect the petition and copy it for
offsite review between 8:30 a.m. and 4:30 p.m. E.S.T., Monday through
Friday. A reasonable fee may be charged for copying. In addition, CMA
will make copies of the petition available upon request. You may call
Mr. Andrew Jakes at CMA's help line at (703) 741-5627 between 8:30 a.m.
and 4:30 p.m. EST, Monday through Friday, for information on how to
obtain a copy of the petition. A reasonable fee may be charged for
copying.
Data Submissions. Comments and additional data should be submitted
(in duplicate if possible) to: The Docket Clerk, Air and Radiation
Docket and Information Office, 401 M Street S.W., Room M-1500 (Mail
Code 6102), Waterside Mall, Washington DC 20460.
FOR FURTHER INFORMATION CONTACT: James B. White, Emission Standards
Division (MD-13), Office of Air Quality Planning and Standards, U.S.
Environmental Protection Agency, Research Triangle Park, North Carolina
27711, telephone (919) 541-0842, electronic mail address:
White.James@epa.gov.
SUPPLEMENTARY INFORMATION: Plain Language. In compliance with President
Clinton's June 1, 1998 Executive Memorandum on Plain Language in
Government Writing, this package is written using plain language.
Therefore,
[[Page 33454]]
the use of ``we'' in this package refers to the EPA. The use of ``you''
refers to the reader and may include State, local or tribal government
agencies, industry, environmental groups, or other interested
individuals.
I. Introduction
A. What Is the List of Hazardous Air Pollutants?
Hazardous air pollutants (HAPs) include a wide variety of organic
and inorganic substances released from large and small industrial
operations, fossil fuel combustion, gasoline and diesel-powered
vehicles, and many other sources. The HAPs have been associated with a
wide variety of adverse health effects, including cancer, neurological
effects, reproductive effects, and developmental effects. The health
effects associated with the various HAPs may differ depending upon the
toxicity of the individual HAP and the particular circumstances of
exposure, such as the amount of chemical present, the length of time a
person is exposed, and the stage in life of the person when the
exposure occurs. The list of HAPs, which includes methyl ethyl ketone,
can be found in section 112(b)(1) of the Act. The HAPs list provides
the basis for research, regulation, and other related EPA activities
under the Act.
B. What Is a Delisting Petition?
A delisting petition is a formal request to the EPA from an
individual or group to remove a specific HAP from the HAPs list. The
removal of a HAP from the list eliminates it from consideration in
EPA's program to promulgate national, technology-based emissions
control standards. This technology-based standards program is commonly
referred to as the MACT (Maximum Achievable Control Technology)
program.
Petitions to add or delete chemicals from the HAPs list are allowed
under section 112(b)(3)(A) of the Act. The Act specifies that any
person may petition the Administrator to modify, by addition or
deletion, the list of HAPs. The EPA Administrator is required under
section 112(b)(3)(A) of the Act to either grant or deny a petition to
delist a specific HAP within 18 months of the receipt of a complete
petition.
To delete a substance from the HAPs list, section 112(b)(3)(C)
requires that the petitioner must provide adequate data on the health
and environmental effects of the substance to determine that emissions,
ambient concentrations, bio-accumulation or deposition of the substance
may not reasonably be anticipated to cause any adverse effects to human
health or adverse environmental effects.
C. How Does EPA Review a Petition To Delist a HAP?
The petition review process proceeds in two phases: a completeness
determination and a technical review. During the completeness
determination, we conduct a broad review of the petition to determine
whether or not all the necessary subject areas are addressed. In
addition, we determine if adequate data, analyses, and evaluation are
included for each subject area. Once the petition is determined to be
complete, we place a ``Notice of Receipt of a Complete Petition'' in
the Federal Register. That Federal Register notice announces a public
comment period on the petition and starts the technical review phase of
our decision making process. The technical review determines whether
the petition has satisfied the necessary requirements and can support a
decision to delist the HAP. All comments and data submitted during the
public comment period are considered during the technical review.
D. How Is the Decision to Delist a HAP Made?
The decision to either grant or deny a petition is made after a
comprehensive technical review of both the petition and the information
received from the public to determine whether the petition satisfies
the requirements of section 112(b)(3)(C) of the Act. If the
Administrator decides to grant a petition, a ``Notice of Proposed Rule
Making'' is published in the Federal Register. That notice proposes a
modification of the HAPs list and presents the reasoning for doing so.
However, if the Administrator decides to deny a petition, a notice
setting forth an explanation of the reasons for denial will be
published instead. A notice of denial constitutes final Agency action
of nationwide scope and applicability, and is subject to judicial
review as provided in section 307(b) of the Act.
II. Completeness Determination and Request for Public Comment
On November 27, 1996, we received a petition from the CMA's Ketone
Panel to remove methyl ethyl ketone (MEK, 2-Butanone)(CAS No. 78-93-3)
from the HAPs list. The petition was presented on behalf of the
producers and consumers of methyl ethyl ketone in the United States.
After reviewing the petition, we found that all of the necessary
subject areas for a human health and environmental risk assessment had
been addressed. However, we determined that there were certain
information gaps in the emission modeling and the ecological risk
assessment that required supplemental information before being
considered complete. To address the modeling issue, we requested
specific modeling data for several of the major emitting sources
identified in the petition. The CMA returned to the largest emitters
and obtained their permission to release the data that had previously
been provided to CMA as a part of a private study. To address the
issues in the ecological risk assessment, we requested additional
modeling to relate emissions of methyl ethyl ketone to ecological
effects. The CMA responded with a report on the output from a fugacity
model which predicted methyl ethyl ketone tendency to either remain
airborne or to collect in soil or water. Fugacity is a thermodynamic
quantity that describes the ``escaping tendency'' of a chemical from an
environmental compartment such as air, soil, water, or biota. It is
used in certain environmental models to describe a chemical's movement
between the different compartments.
After reviewing all of the supplemental information, we have
determined that the essential subject areas have been addressed.
Therefore, the petition is complete and ready for technical review. The
CMA's last supplement which occurred August 31, 1998 marked the start
of the 18-month technical review and decision period. Today's notice
initiates our comprehensive technical review of the petition and
invites public comment on the substance of the petition as described
above.
III. Description of Petition
The original petition and the supplemental materials provided by
CMA contain the following information:
(A) Identification and location of facilities producing or using
methyl ethyl ketone.
(B) Background data on methyl ethyl ketone, including chemical and
physical properties data and production and use data.
(C) Toxicological data on human heath and environmental effects of
methyl ethyl ketone. These data include CMA's proposed recalculation of
the air inhalation reference concentration (RfC) currently contained in
the EPA's Integrated Risk Information System (IRIS). The RfC is a
quantitative estimate of an inhalation exposure to humans that is
likely to be without appreciable risk of adverse impacts over a
lifetime. The IRIS is an electronic data base prepared and maintained
by EPA that contains information on human health
[[Page 33455]]
effects that may result from exposure to various chemicals in the
environment.
(D) Estimated emissions of methyl ethyl ketone derived from the
most recent version of the Toxic Release Inventory (TRI). The TRI is an
emissions inventory database developed under section 313 of the
Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986.
(E) Tiered air dispersion modeling that provides estimates of the
ambient concentration of methyl ethyl ketone adjacent to those
facilities that use it. Tiered modeling involves the use of successive
modeling techniques to move from conservative ``worst case'' estimates
of the ambient concentrations of a substance emitted from a source
toward more realistic site-specific estimates of the ambient
concentrations.
(F) Characterization of the exposures and risks from methyl ethyl
ketone to human health and the environment.
(G) Documentation of a literature search on methyl ethyl ketone
conducted immediately prior to the filing of the petition. This
includes an identification of the data bases searched, the search
strategy, and printed results.
(H) Printed copies of all human, animal, in vitro, or other
toxicity studies cited in the literature search.
(I) Environmental effects data characterizing the fate of methyl
ethyl ketone emitted to the atmosphere. This includes atmospheric
residence time, solubility, phase distribution, vapor pressure,
octanol/water partition coefficients, particle size, adsorption
coefficients, information on atmospheric transformations, potential
degradation or transformation products, and bio-accumulation potential.
(J) Other relevant considerations, such as CMA's petition to delist
methyl ethyl ketone under EPCRA section 313.
(K) List of all support documents in the petition.
At the time of the petition, only three companies: Exxon Chemical
Company, Hoechst Celanese, and Shell Chemical, produced methyl ethyl
ketone. The estimated total domestic capacity in 1995 was approximately
595 million pounds. The 1994 Toxic Release Inventory (TRI) shows that
over 2,300 facilities reported emissions associated with the use of
methyl ethyl ketone and that 85 percent of these facilities reported
emissions of less than 25 tons per year.
The petition describes methyl ethyl ketone as being both a solvent
and chemical intermediate. When used as a solvent, it is highly
efficient for dissolving a wide variety of resins. Therefore, it is
widely used in surface coatings, adhesives, inks, and traffic marking
paints. Methyl ethyl ketone is also used as a solvent in cleaning
fluids and dewaxing agents, and in the extraction of fats, oils, waxes,
and resins. It is especially valuable in the formulation of high-solids
coatings which are being used to reduce emissions of volatile organic
compounds (VOCs) from many types of coatings. Methyl ethyl ketone is
reported to occur naturally as an emission from plants such as European
firs, junipers, cedars, cypress trees, and ferns. It has also been
identified as a natural component of several foods.
Based on an analysis of the TRI, the petition states that
inhalation is the only significant route of human exposure to methyl
ethyl ketone emissions. Using the most recent TRI data as input in a
tiered air dispersion modeling approach, the petition develops
estimates of the maximum annual and 24-hour concentrations anticipated
to occur at the boundaries of facilities known to emit methyl ethyl
ketone. The petition compares the output from the air models and
available IRIS health data to conclude that, given the low
concentrations anticipated to occur at the facility boundaries, methyl
ethyl ketone cannot reasonably be anticipated to cause either acute or
chronic adverse health effects to people living nearby these
facilities.
This conclusion is based on methyl ethyl ketone's relatively low
toxicity, the estimated low ambient concentrations, and a proposed
revision of the IRIS RfC for methyl ethyl ketone. The proposed revision
increases methyl ethyl ketone's RfC from 1.0 mg/m3 to 3.3
mg/m3. The proposal is based on guidelines published by EPA
in 1994 (EPA Office of Research and Development, ``Methods for the
Derivation of Inhalation Reference Concentrations and Application of
Inhalation Dosimetry,'' EPA No. 600/8-90/066F (October 1994)). This
proposed RfC and the assumptions underlying its derivation will be
evaluated during our technical review.
The petition also uses a fugacity model to demonstrate that methyl
ethyl ketone tends to remain in the air rather than to accumulate in
water or on soil. Data is provided to support the position that in the
concentrations expected to occur in the environment, methyl ethyl
ketone is non-toxic to plants and animals. It is readily degradable
through natural process and does not tend to accumulate in living
organism. Based on the lack of toxicity and the limited persistence in
the environment, the petition concludes that methyl ethyl ketone does
not pose a significant adverse effect to the environment.
Dated: June 14, 1999.
Robert D. Brenner,
Acting Assistant Administrator, Office of Air and Radiation.
[FR Doc. 99-15981 Filed 6-22-99; 8:45 am]
BILLING CODE 6560-50-P
