[Federal Register Volume 69, Number 137 (Monday, July 19, 2004)]
[Proposed Rules]
[Pages 42954-42956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16335]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[OAR-2004-0084; FRL-7788-8]


List of Hazardous Air Pollutants, Petition Process, Lesser 
Quantity Designations, Source Category List; Petition To Delist Methyl 
Isobutyl Ketone

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of receipt of a complete petition to delist methyl 
isobutyl ketone from the list of hazardous air pollutants.

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SUMMARY: The EPA is announcing the receipt of a complete petition from 
the Ketones Panel of the American Chemistry Council (ACC) (formerly the 
Chemical Manufacturers Association) requesting EPA to remove the 
chemical methyl isobutyl ketone (MIBK) (hexone) (Chemical Abstract 
Service No. 108101) from the list of hazardous air pollutants (HAP) 
contained in section 112(b)(1) of the 1990 Clean Air Act (CAA). We have 
determined that the ACC's original petition dated April 22, 1997, and 
the addenda provided by the ACC through October 17, 2003, will support 
an assessment of the human health impacts associated with people living 
in the vicinity of facilities emitting MIBK. In addition, the data 
submitted by the ACC will support an assessment of the environmental 
impacts associated with emissions of MIBK to the ambient air and 
deposited onto soil or water. Consequently, we have concluded that 
ACC's petition is complete as of October 17, 2003, the date of the last 
addendum, and is ready for public comment and the technical review 
phase of our delisting procedure.
    The EPA 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 MIBK that may be relevant to our technical review.

DATES: Written comments must be received on or before August 18, 2004.

ADDRESSES: Submit your comments, identified by Docket ID No. OAR-2004-
0084, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Agency Website: http://www.epa.gov/edocket. EDOCKET, EPA's 
electronic public docket and comment system, is EPA's preferred method 
for receiving comments. Follow the on-line instructions for submitting 
comments.
     Mail: Air and Radiation Docket and Information Center 
(Mail Code 6102T), Room B108, 1200 Pennsylvania Ave., NW., Washington, 
DC 20460.
     Hand Delivery: Air and Radiation Docket and Information 
Center (Mail Code 6102T), Room B102, U.S. EPA, 1301 Constitution 
Avenue, NW., Washington, DC 20460. Such deliveries are only accepted 
during the Docket's normal hours of operation, and special arrangements 
should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. OAR-2004-0084. 
The EPA's policy is that all comments received will be included in the 
public docket without change and may be made available online at http://www.epa.gov/edocket, including any personal information provided, 
unless the comment includes information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected through EDOCKET, regulations.gov, or e-
mail. The EPA EDOCKET and the federal regulations.gov websites are 
``anonymous access'' systems, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an e-mail comment directly to EPA without 
going through EDOCKET or regulations.gov, your e-mail address will be 
automatically captured and included as part of the comment that is 
placed in the public docket and made available on the Internet. If you 
submit an electronic comment, EPA recommends that you include your name 
and other contact information in the body of your comment and with any 
disk or CD-ROM you submit. If EPA cannot read your comment due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your comment. Electronic files should avoid 
the use of special characters, any form of encryption, and be free of 
any defects or viruses. For additional instructions on submitting 
comments, go to the SUPPLEMENTARY INFORMATION section of this document.
    Docket: All documents in the docket are listed in the EDOCKET index 
at http://www.epa.gov/edocket. Although listed in the index, some 
information is not publicly available, i.e., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available either electronically in EDOCKET or in hard 
copy at the Air and Radiation Docket, EPA/DC, EPA West, Room B102, 1301 
Constitution Ave., NW., Washington, DC. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the Air and Radiation Docket is 
(202) 566-1742.

FOR FURTHER INFORMATION CONTACT: Mr. Mark Morris, Office of Air Quality 
Planning and Standards, Emission Standards Division (Mailcode C404-01), 
U.S. EPA, 109 TW Alexander Drive, Research Triangle Park, NC 27711; 
telephone number: (919) 541-5416; fax number: (919) 541-0840; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
EDOCKET, regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as 
CBI and then identify electronically within the disk or CD ROM the 
specific information that is claimed as CBI). In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments, 
remember to:
     Identify the rulemaking by docket number and other 
identifying information (subject heading, Federal Register date and 
page number).
     Follow directions--The agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives 
and substitute language for your requested changes.
     Describe any assumptions and provide any technical 
information and/or data that you used.
     If you estimate potential costs or burdens, explain how 
you arrived at your estimate in sufficient detail to allow for it to be 
reproduced.

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     Provide specific examples to illustrate your concerns, and 
suggest alternatives.
     Explain your views as clearly as possible, avoiding the 
use of profanity or personal threats.
     Make sure to submit your comments by the comment period 
deadline identified.

II. Petitions To Delist a Hazardous Air Pollutant

A. What Is the List of Hazardous Air Pollutants?

    The list of HAP includes 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 HAP 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 HAP 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 HAP, which includes MIBK, can be found in section 112(b)(1) of the 
CAA. The HAP list provides the basis for research, regulation, and 
other related EPA activities under the CAA.

B. What Is a Delisting Petition?

    A delisting petition is a formal request to EPA from an individual 
or group to remove a specific HAP from the HAP 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 
Maximum Achievable Control Technology (MACT) program.
    Petitions to add or delete chemicals from the HAP list are allowed 
under section 112(b)(3)(A) of the CAA. The CAA specifies that any 
person may petition the Administrator to modify, by addition or 
deletion, the list of HAP. The EPA Administrator is required under 
section 112(b)(3)(A) of the CAA 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 HAP list, CAA 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 all of 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 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 CAA. If the 
Administrator decides to grant a petition, a proposal will be published 
in the Federal Register announcing that decision and the opportunity 
for public comment. That notice would propose a modification of the HAP 
list and present 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 CAA.

III. Completeness Determination and Request for Public Comment

    On April 22, 1997, we received a petition from the ACC's Ketones 
Panel to remove MIBK from the HAP list. Because of incomplete 
toxicological information on MIBK, discussions between EPA and the 
petitioner after the submittal led to a mutual agreement to suspend 
review of the petition to allow time for a two-generation reproductive 
study. That study was completed in 2000 and was reviewed as part of 
EPA's ``Toxicological Review of Methyl Isobutyl Ketone'' which was 
completed in March 2003 (EPA-635/R-03-002). After the publication of 
that document, the petitioner submitted an addendum on October 17, 
2003, requesting that we evaluate the petition for completeness and 
grant the petition.
    After reviewing the original petition and the two addenda, we have 
determined that all of the necessary subject areas for a human health 
and environmental risk assessment have been addressed. Therefore, the 
petition is complete and ready for technical review. The ACC's last 
addendum of October 17, 2003, 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.

IV. Description of Petition

    The original petition and addenda provided by the ACC contain the 
following information:
     Identification and location of facilities producing or 
using MIBK.
     Background data on MIBK, including chemical and physical 
properties data and production and use data.
     Toxicological data on human health and environmental 
effects of MIBK.
     Estimated emissions of MIBK derived from the 2001 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.
     Tiered air dispersion modeling that provides estimates of 
the ambient concentration of MIBK adjacent to those facilities that 
produce or 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.
     Characterization of the exposures and risks from MIBK to 
human health and the environment.
     Documentation of a literature search on MIBK conducted 
immediately prior to the filing of the petition. This includes an 
identification of the data bases searched, the search strategy, and 
printed results.
     Copies of relevant human, animal, in vitro, or other 
toxicity studies cited in the literature search.
     Environmental effects data characterizing the fate of MIBK 
emitted

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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.
     Other relevant considerations, such as ACC's petition to 
delist MIBK under EPCRA section 313.
     List of all support documents in the petition.
    The petition lists three companies (Eastman Chemical, Shell 
Chemical, and Union Carbide) that produced 220 million pounds 
domestically in 1995. The petition describes MIBK 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. The MIBK is also used as a solvent in cleaning fluids and 
dewaxing agents, and in the extraction of fats, oils, waxes, and 
resins. It is used in the formulation of high-solids coatings which are 
being used to reduce emissions of volatile organic compounds (VOC) from 
many types of coatings. The MIBK is reported to occur naturally in 
plants and animals, and has been identified as a natural component of 
several foods.
    According to the petition, based on the chemical and physical 
properties of MIBK, inhalation is the only significant route of human 
exposure to MIBK emissions. Using the most recent TRI data and some 
site-specific 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 MIBK. The petition compares modeling output to 
available health data to conclude that, given the low concentrations 
anticipated to occur at facility boundaries, MIBK cannot reasonably be 
anticipated to cause either acute or chronic adverse health effects to 
people living near these facilities.
    The petition discusses the results of fugacity modeling that was 
performed to evaluate the fate of MIBK in air, water, soil and 
sediment. The results of the modeling indicate that the concentrations 
of MIBK in water, soil, and sediment are well below levels expected to 
pose hazards to human health or the environment.

    Dated: July 12, 2004.
Robert D. Brenner,
Principal Deputy Assistant, Administrator for Air and Radiation.
[FR Doc. 04-16335 Filed 7-16-04; 8:45 am]
BILLING CODE 6560-50-P