[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.J[email protected].

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

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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