[Federal Register Volume 68, Number 173 (Monday, September 8, 2003)]
[Rules and Regulations]
[Pages 52978-52984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22770]



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Part II





Environmental Protection Agency





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40 CFR Part 355



Emergency Planning and Community Right-to-Know Act; Extremely Hazardous 
Substances List; Modification of Threshold Planning Quantity for 
Isophorone Diisocyanate; Final Rule

  Federal Register / Vol. 68, No. 173 / Monday, September 8, 2003 / 
Rules and Regulations  

[[Page 52978]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 355

[FRL-7554-9]
RIN 2050-AE43


Emergency Planning and Community Right-to-Know Act; Extremely 
Hazardous Substances List; Modification of Threshold Planning Quantity 
for Isophorone Diisocyanate

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule amends the list of extremely hazardous substances 
(EHS) issued under the Emergency Planning and Community Right-to-Know 
Act (EPCRA) by changing the threshold planning quantity (TPQ) for 
isophorone diisocyanate (IPDI) from 100 pounds to 500 pounds.

DATES: This rule is effective October 8, 2003.

ADDRESSES: Copies of the documents relevant to this action (Docket No. 
SFUND-2002-0009) are available for public inspection during normal 
business hours from 8:30 a.m. to 4:30 p.m., Monday through Friday, 
excluding federal holidays, at the Superfund Docket in the EPA Docket 
Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., 
Washington, DC.

FOR FURTHER INFORMATION CONTACT: For general information, contact the 
Emergency Planning and Community Right-to-Know Hotline at (800) 424-
9346 or (703) 412-9810, TDD (800) 553-7672, http://www.epa.gov/epaoswer/hotline/. For questions on the applicability of provisions 
contained in 40 CFR part 355 or on the contents of this document, 
contact: Sicy Jacob, Chemical Emergency Preparedness and Prevention 
Office (5104A), Environmental Protection Agency, 1200 Pennsylvania 
Avenue, NW., Washington DC 20460, Telephone: 202-564-8019; Fax: 202-
564-8233; email: [email protected].

SUPPLEMENTARY INFORMATION:

General Information

A. Affected Entities

    Entities that may be affected by this action are those facilities 
subject to 40 CFR part 355, Emergency Planning and Release 
Notification.

B. How Can I Get Copies of This Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under Docket ID No. SFUND-2002-0009. You may also refer to 
Docket ID No. 300-PQ-R2 for any technical documents referenced in the 
preamble to this document. The official public docket consists of the 
documents specifically referenced in this action, any public comments 
received, and other information related to this action. The public 
docket does not include Confidential Business Information (CBI) or 
other information the disclosure of which is restricted by statute. The 
official public docket is the collection of materials that is available 
for public viewing at the Superfund Docket in the EPA Docket Center 
(EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, 
DC. The EPA Docket Center 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 Reading Room is (202) 566-1742, and the 
telephone number for the Superfund Docket is (202) 566-0276.
    2. Electronic Access. You may access this Federal Register document 
electronically through the EPA Internet under the Federal Register 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Once in the system, select ``search,'' 
then key in the appropriate docket identification number.

Outline

I. Introduction and Background
    A. Statutory Authority
    B. Background
II. EPA's Methodology for Establishing TPQs for Liquids
III. Explanation of the Error in the October 1994 Proposed Rule
IV. Response to Comments on the October 12, 1994 Proposed Rule
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination with 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children from 
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions that Significantly Affect 
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations
    K. Congressional Review Act

I. Introduction and Background

A. Statutory Authority

    This final rule is issued under sections 302 and 328 of the 
Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA).

B. Background

    On October 17, 1986, the President signed into law the Superfund 
Amendments and Reauthorization Act of 1986 (``SARA''). Public Law 99-
499 (1986). Title III of SARA established a program designed to require 
state and local planning and preparedness for spills or releases of 
hazardous substances and to provide the public and local governments 
with information concerning potential chemical hazards in their 
communities. This program is codified as the Emergency Planning and 
Community Right-to-Know Act of 1986 (EPCRA), 42 U.S.C. 11001-11050.
    EPCRA required EPA to publish a list of Extremely Hazardous 
Substances (EHS) and to establish threshold planning quantities for 
each of these EHSs. Under EPCRA section 302, a facility which has 
present an EHS in excess of its threshold planning quantity (TPQ) must 
notify the State emergency response commission and local emergency 
planning committee as well as participate in local emergency planning 
activities.
    The EHS list was established by EPA to identify chemical substances 
which could cause serious irreversible health effects from accidental 
releases (51 FR 13378). The EHS list and its TPQs are intended to help 
communities focus on the substances and facilities of the most 
immediate concern for emergency planning and response.
    The TPQs are not absolute levels above which the EHS are dangerous 
and below which they pose no threat at all. The TPQs provide a starting 
point for identification of facilities to community response planners 
so that they can determine whether or not these facilities pose a 
potential problem in the event of an accidental release. EPA encourages 
communities to go beyond the EHS list when evaluating the hazards of 
facilities

[[Page 52979]]

in their community, in that facilities handling chemicals not on the 
EHS list could be as hazardous as those handling EHSs.
1. Regulatory Background
    The EHS list and their TPQs are codified in 40 CFR part 355, 
appendices A & B. EPA's explanation for the methodologies used to 
determine whether to list a substance as an EHS and for deriving the 
TPQs is found in preambles to the Federal Register notices which 
promulgated these rules and in technical support documents in the 
rulemaking records. The relevant notices were published in the Federal 
Register on November 17, 1986 (51 FR 41570) and April 22, 1987 (52 FR 
13378).
    EPA first published the EHS list and TPQs along with the 
methodology for determining TPQ in the November 17, 1986 interim final 
rule. In the April 22, 1987 final rule, EPA made a number of revisions. 
Among other things, the April 1987 rule republished the EHS list, with 
the addition of four new chemicals and revised the methodology for 
determining some TPQs. EPA has since received several petitions to 
amend the EHS list.
2. Summary of October 1994 Proposed Rulemaking
    In the October 12, 1994 (59 FR 51816) proposed rulemaking, EPA 
responded to seven petitions requesting action on substances listed as 
EHSs. Among these petitions, H[uuml]ls America Inc. petitioned EPA to 
delist isophorone diisocyanate (IPDI) (CAS No. 4098-71-9). EPA denied 
the petition to delist IPDI because it meets the criteria for an EHSs. 
However, in considering this petition, EPA noted that the TPQ had been 
determined based on a mistaken assumption that IPDI is a reactive solid 
at standard temperature, when in fact it is a liquid and not highly 
reactive. Accordingly, using the methodology for calculating TPQs for 
liquids, EPA proposed in 1994 to raise the TPQ for IPDI from 100 to 
1,000 pounds, even though H[uuml]ls America did not request this change 
in their petition.
    As a result of EPA's action, H[uuml]ls America filed a lawsuit in 
federal court challenging EPA's denial of the delisting petition for 
IPDI. The Agency's decision not to delist IPDI was upheld by the United 
States Court of Appeals for the District of Columbia Circuit (DC Cir.) 
in H[uuml]ls America v. Browner, 83 F.3d 445 (1996). Accordingly, 
today's rulemaking does not address any issues regarding whether IPDI 
should be removed from the EHS list under EPCRA, but is limited solely 
to the appropriateness of the TPQ for IPDI.

II. EPA's Methodology for Establishing TPQs for Liquids

    The TPQs developed for EHSs are based on a ranking of the EHSs 
according to their potential to become airborne and disperse and their 
toxicological properties, with adjustments based on chemical reactivity 
and other factors. The Immediately Dangerous to Life and Health (IDLH) 
level developed by the National Institute of Occupational Safety and 
Health (NIOSH), or an approximation of the IDLH based on animal 
toxicity data, is used as an index of toxicity while the physical state 
and volatility of the substance are used to derive an index of the 
chemical's potential to become airborne and disperse. These two indices 
are combined to produce an overall risk score or ``ranking factor'' 
defined as IDLH/V, where V is the index of potential to become airborne 
and disperse. TPQs are then assigned to groups of EHSs according to 
their relative ranking. The lowest rank (highest concern) is assigned 
low quantities and the highest rank (lowest concern) is assigned high 
quantities.
    The index of potential to become airborne and disperse (V) is 
derived using the physical state of the substance and a measure of its 
volatility. For EHSs that are gases at ambient conditions and powdered 
solids with a particle size less than 100 micron, V is assumed to have 
a value of 1, indicating that in an accidental release, the chemical 
could easily become airborne and disperse. Solids in non-powdered form 
are assigned the highest TPQ meaning that chemicals in this physical 
state are not likely to become airborne and disperse.
    For liquid EHSs, V is derived from the rate of volatilization 
expected from a spill of the liquid at its boiling point. The rate of 
volatilization is driven by the molecular weight of the substance and 
its boiling point temperature as in the following equation:

V = 1.6M0.67/(T + 273)

where M is the molecular weight of the substance and T is the boiling 
temperature ([deg]C). Note that for liquids with low boiling points 
(volatile liquids), V will approach 1 (more like a gas), while high 
boiling liquids have a V much less than 1.
    The Agency could have evaluated the rate of volatilization from a 
spill of the liquid at ambient conditions rather than at the liquid's 
boiling point. Typically, to calculate the rate of volatilization of a 
liquid at ambient conditions, an ambient temperature must be chosen and 
the liquid's vapor pressure at that ambient temperature must be known. 
Chemical reference books often publish the vapor pressure for many 
common substances at 20 or 25 [deg]C. However, some of the liquids on 
the EHS list either have a vapor pressure at a different temperature or 
they have no published vapor pressure. The Agency could have estimated 
or calculated vapor pressures for these substances but the accuracy of 
such estimates or calculations could be questioned. A more critical 
question is the choice of an appropriate ambient temperature. Ambient 
temperatures vary widely across the United States and an accidental 
release scenario could involve heat from, for example, a loss of 
reactor cooling or from a fire. The choice of an appropriate ambient 
temperature would be influenced by site-specific or release scenario 
specific factors. Since the Agency needed to apply a methodology 
uniformly to all liquid EHSs rather than chemical-by-chemical or site-
by-site, the Agency therefore chose to evaluate the rate of 
volatilization using the substance's boiling point. All of the liquids 
on the EHS list have a published boiling point.
    As noted above, once V is determined, the ``ranking factor'' is 
calculated from IDLH/V. If an IDLH value is not available, as is the 
case for most of the EHSs, EPA uses an IDLH equivalent value estimated 
from acute animal toxicity data. Data such as the lowest lethal 
airborne concentration (LCLO), lethal airborne concentration 
for 50% of the test animals (LC50), lowest lethal dose 
(LDLO), or lethal dose for 50% of the test animals 
(LD50) are used. NIOSH has indicated that the IDLH is most 
similar to the LCLO; the other toxicity data needs to be 
adjusted and converted to an airborne dose comparable to an IDLH as 
follows: (1) Estimated IDLH = LC50 x 0.1; (2) estimated IDLH 
= LD50 x 0.01; and (3) estimated IDLH = LDLO x 
0.1.
    So, for each liquid, gas, and solid on the EHS list, EPA calculates 
the ranking factor as described above. Once all the chemicals are 
ranked, they are grouped by orders of magnitude of ranking factor and 
threshold quantities are assigned to these groups. The table below 
shows the ranking factor and the threshold quantities assigned to them. 
(Source: Threshold Planning Quantities Technical Support Document, 
April 7, 1987).

[[Page 52980]]



 
------------------------------------------------------------------------
                                                            Threshold
                    Ranking factor                        quantity (lb)
------------------------------------------------------------------------
< 1 x 10-3............................................                 1
=10-3 to <10-2.............................                10
=10-2 to <10-1.............................               100
=10-1 to <1................................               500
=1 to <10..................................           1,000 a
=10........................................            10,000
------------------------------------------------------------------------

    Since there was no IDLH value available for IPDI at the time the 
EHS list was developed (and there still is not one), EPA estimates the 
IDLH equivalent for IPDI by multiplying its LC50 of 0.12 mg/
l over a 4-hour exposure period by 0.1. This results in an IDLH value 
of 0.012 mg/l. To calculate V, EPA uses the boiling point for IPDI of 
350 degrees Centigrade and a molecular weight of 222 g/mole in the 
above equation to obtain 0.096. Then the index value is derived by 
dividing the level of concern (0.012) by the V factor (0.096) to obtain 
0.13. Using the ranking factor value for IPDI, of 0.13, and the table 
above, the TPQ value should be 500 pounds.

III. Explanation of the Error in the October 1994 Proposed Rule

    As part of the Agency's review of the petition to delist IPDI from 
the EHS list, EPA discovered that IPDI was mistakenly listed as a 
reactive solid, as opposed to a liquid. As a result, EPA recalculated 
IPDI's ranking factor using the equation listed in the previous section 
of this preamble and proposed in October 1994, to raise the TPQ from 
100 to 1,000 pounds.
    During the process of finalizing the rule, EPA reviewed all 
documents and memos related to the October 1994 proposed rule. During 
the review, EPA discovered that an error was made in reading the table 
of ranking factors and the corresponding threshold quantities. To be 
certain, EPA again reviewed IPDI's physical/chemical properties and re-
calculated the ranking factor. The IDLH, V factor, and ranking factor 
were calculated correctly in the 1994 proposed rule, however, the 
Agency incorrectly identified the TPQ for IPDI; the proposal should 
have stated 500 pounds instead of 1,000 pounds. EPA is now finalizing 
the TPQ for IPDI to the correct value of 500 pounds.
    On February 27, 2002, EPA sent a letter to Degussa Corporation 
(successor to ``H[uuml]ls America, Inc.'') informing them of the error 
and provided them an additional opportunity to submit comments. The 
letter explained the error made in the 1994 proposal and discussed the 
correct TPQ value. Degussa stated that they do not have any additional 
comments other than those submitted in response to the 1994 proposal. 
Accordingly, below, EPA responds to those comments filed by Huls 
America in 1994.

IV. Response to Comments on the October 12, 1994 Proposed Rule

    EPA received comments only from Huls America. While Huls America 
disagreed with EPA's decision to deny the petition to delete IPDI from 
the EHS list, the company acknowledged that the issue would be 
addressed in the litigation. Since the listing of the IPDI has been 
upheld by the court, this notice will not deal with that issue.
    With respect to the TPQ for IPDI, Huls America argues that the 
highest TPQ category of 10,000 pounds should be assigned. This is 
because IPDI is non-volatile and is toxic only at levels well above its 
saturated vapor concentration. Because EPA has not considered relative 
vapor pressure in calculating TPQs for such non-volatile compounds, the 
TPQs bear no relationship to the very low potential for compounds to 
disperse beyond a facility boundary. Therefore, IPDI, which has a very 
low vapor pressure is unlikely to present any risk at the fenceline in 
the event of a release. The commenter also disagreed with EPA's TPQ 
methodology, particularly with respect to EPA's assumption that 
dispersion is relatively similar from chemical to chemical. The 
commenter stated that the aerosol acute toxicity data do not support 
the need to set the TPQ for IPDI below 10,000 pounds. In fact, Huls 
argues that because IPDI's toxicity was determined using an aerosol 
form of the chemical, the dispersability of IPDI for calculating the 
TPQ should be based on the aerosol form rather than on liquid 
volatility. The commenter also stated that IPDI is manufactured and 
processed in closed vessels which are not under pressure. So, there is 
less likelihood that accidents may occur.
    EPA disagrees with Huls' assertion that it did not consider 
relative vapor pressure and that the TPQs for non-volatile compounds 
such as IPDI bear no relationship to the very low potential for these 
compounds to disperse beyond a facility boundary as a result of a spill 
or release. In general, non-volatile liquid chemicals have relatively 
low vapor pressure and relatively high boiling points. These substances 
are not as likely as volatile liquids to disperse beyond a facility 
boundary. As described above, EPA uses the liquid boiling point to 
calculate a V factor which is used as a relative measure of the ability 
of the substance to become airborne and disperse downwind. Non-volatile 
substances with high boiling points will give a small V factor which 
generates a larger ranking factor than volatile substances with a large 
V factor. The V factor is likely to be the same using either the 
substance's boiling point or ambient vapor pressure. The larger the 
ranking factor, the greater the TPQ. Therefore, a large TPQ would 
reflect a relative inability of a substance to travel off-site.
    EPA believes that boiling point is a reflection of relative vapor 
pressure since non-volatile liquids have a low vapor pressure and a 
correspondingly high boiling point while volatile liquids have a high 
vapor pressure and a correspondingly low boiling point. Of the 183 
liquid chemicals on the EHS list, only 18 chemicals have less than or 
the same vapor pressure as IPDI, and only 17 chemicals have higher or 
the same boiling point as IPDI. Therefore, when compared to the other 
chemicals on the EHS list, the ability of IPDI to disperse is 
relatively the same when considering either vapor pressure (as the 
petitioner requests) or boiling point (as the methodology now 
considers). For this reason, changing the methodology from boiling 
point to vapor pressure will not likely have a significant impact on 
IPDI's rank in comparison to other chemicals and consequently, its TPQ. 
While both of these factors demonstrate that IPDI under standard 
temperatures and pressures is less likely to disperse (relative to the 
other liquids on the EHS list), its TPQ is based on its boiling point 
and its acute toxicity (not by boiling point or toxicity alone) like 
other listed liquids.
    EPA also disagrees that its TPQ methodology is improper, 
particularly with respect to the assumption that dispersion is 
relatively similar from chemical to chemical. EPA recognizes that once 
airborne, fine powders, aerosols, mists, or dense or lighter than air 
vapor clouds or gases may disperse differently from one another, 
depending on the density and concentration of the substance in the air, 
the air temperature, humidity, and other chemical- and dispersion-
specific factors. A rigorous analysis of the unique dispersion 
characteristics could be conducted for each listed EHS substance. 
However, such an analysis is highly influenced by site-specific factors 
such as meteorology, terrain, and the accidental release scenario. 
Since the Agency does not have site-specific data for all sites 
potentially handling the EHS substances and a methodology for 
determination of the TPQ needs to be uniformly applied, the Agency 
assumed, that for purposes of a relative ranking, that the airborne 
dispersion of particles and vapors will likely be similar across the 
range of

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listed gases, liquids and solids that become airborne.
    EPA also notes that it does not use only dispersion potential or 
only toxicity to determine the TPQ. Instead, the method that EPA chose 
to establish TPQs for substances on the EHS list uses a combination of 
the toxicity of the chemical and the potential for these compounds to 
disperse beyond the facility boundary. Further, EPA did not assign TPQs 
based on any particular accident scenario or any specific handling 
situation. Instead, EPA chose to rank the chemicals against each other 
to get a relative idea of the potential accidental release significance 
or hazard associated with that chemical; a chemical with a ``low'' rank 
is more hazardous than one with a ``high'' rank (``hazard'' being a 
combination of toxicity and dispersion potential). EPA chose not to 
rank only by toxicity because a highly toxic chemical such as IPDI (a 
non-volatile substance) would be assigned a very low TPQ while a 
slightly less toxic but volatile substance would be assigned a greater 
TPQ.
    H[uuml]ls also argues that because IPDI's toxicity was determined 
using an aerosol form of the chemical, the dispersion factor portion of 
the TPQ should consider the aerosol form rather than liquid 
volatilization based on boiling point. The Agency disagrees with this 
comment. Substances were added to the EHS list if dermal, oral, or 
inhalation toxicity test results meet certain toxicity criteria. While 
it is likely that toxic gases are listed because of inhalation 
toxicity, liquids and solids could be listed not only because of 
inhalation toxicity but also dermal or oral toxicity. In an accidental 
release scenario, hazardous chemicals could be dispersed in many ways 
generating human exposure, potentially via all three pathways (e.g. via 
inhalation, oral or dermal exposure). Consequently, for purposes of 
determining the TPQ, the Agency chose to focus on the substance's 
physical state to determine the likely route of exposure that might 
result from an accidental release rather than the state of the 
substance used for toxicity testing. In other words, gases and liquids 
would become airborne due to volatilization while solids become 
airborne due to the force of an event such as an explosion. Certainly, 
liquids could become airborne as a result of an explosion generating an 
exposure not only to vapor but to aerosols that would be generated by 
the force of that explosion. If the Agency had used this approach to 
determine dispersability, all liquid substances would essentially have 
the same dispersion potential and would be ranked by their toxicity. In 
this case, the TPQ for IPDI would end up being very low due to its high 
acute toxicity level in comparison to other liquids. EPA notes that 
H[uuml]ls' comment does not suggest a way to determine a relative 
ranking using an aerosol form, but simply argues that there is no basis 
for a TPQ of anything less than the maximum of 10,000 pounds. In fact, 
there is no basis for a TPQ of 10,000 pounds while there is ample 
toxicity data to suggest a much lower TPQ.
    EPA acknowledges that releases of IPDI, and any other chemical on 
the EHS list, will not always result in an off-site consequence. 
However, since the requirement under EPCRA section 302 is for 
facilities to be included in the local preparedness efforts, the level 
of effort necessary for the facility to comply with section 302 is up 
to local planners. It is not possible for EPA to determine how all of 
the chemicals on the EHS list will behave during all potential 
processing and accidental release scenarios (including the chemical 
being involved in a building fire or explosion). EPA agrees that test 
data may be obtained by exposing the chemical to extreme conditions, 
however, these results would demonstrate that IPDI can be toxic under 
certain circumstances at relatively low concentration levels. TPQs 
including that for IPDI, are set based on toxicity and ability to 
disperse, relative to the other chemicals on the EHS list. While EPA 
takes toxicity and the chemical's ability to be dispersed into account 
in determining the TPQ, EPA believes the actual threat of off-site 
consequences posed by the actual processing conditions at the facility 
is best determined at the local level. If it is extremely unlikely that 
chemicals at a specific facility could cause off-site impacts, the 
local community may request little effort from the facility. Site 
specific factors (including whether the chemical is processed under 
high pressures and temperatures) can be discussed at this level.
    The petitioner has also argued that since IPDI is manufactured and 
processed in closed vessels which are not under pressure, there is 
virtually no likelihood that it would disperse beyond the site of 
release. EPA disagrees. Even if H[uuml]ls' America does manufacture or 
process in closed vessels which are not under pressure, there may be 
some end users of this chemical that may use it for other manufacturing 
processes which may be at high pressure or temperature or the closed 
vessels could be exposed to fire. EPA is not saying that the TPQ that 
is now being set for IPDI (500 pounds) or any quantity for that matter, 
will definitely travel off-site and cause major consequences. As EPA 
stated in the April 1987 final rule and the technical support documents 
supporting that rule, TPQs are for reporting purposes only, in other 
words, to provide information to local planning committees to focus 
their emergency planning and response efforts.
    It is important to note that the Agency considered other methods 
for the development of the threshold planning quantities. After 
considerable analysis and review of public comments on the proposed 
rule, the Agency chose to develop the TPQs using a relative ranking 
method that considers the toxicity and the chemical's ability to become 
airborne. The other methods had more limitations than this approach. 
The first method considered involved predicting a specific quantity for 
each chemical that, if accidentally released, would result in 
significant acute health effects at a fixed distance from the release 
site. However, this approach is affected greatly by site-specific 
factors, such as the potential release scenario, weather and dispersion 
conditions, and processing conditions. Therefore, the Agency decided 
not to adopt this approach. Another method that the Agency considered 
was to assign categories of threshold planning quantities to groups of 
chemicals ranked by their toxicity. As noted above, those chemicals 
that are highly toxic (such as IPDI) and relatively non-volatile could 
be assigned a very low TPQ while a slightly less toxic but volatile 
substance would be assigned a greater TPQ. Since this does not seem 
appropriate from an emergency planning and preparedness perspective, 
the Agency rejected this approach. One last method considered was to 
assign a default quantity of 2 pounds for each EHS. If the Agency did 
not take any action to assign a TPQ for an EHS, the statutory threshold 
of 2 pounds would have been effective. Of these four methods, the 
Agency believes that the relative ranking method using the toxicity of 
the chemical, its molecular weight and boiling point to rank and assign 
a threshold planning quantity, was the most appropriate. For a more 
detailed explanation of each of these methods, see the November 17, 
1986 interim final rule, the April 22, 1987 final rule, and the 
technical support documents.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency

[[Page 52982]]

must determine whether the regulatory action is ``significant'' and 
therefore subject to Office of Management and Budget (OMB) review and 
the requirements of the Executive Order. The Order defines 
``significant regulatory action'' as one that is likely to result in a 
rule that may: (1) Have an annual effect on the economy of $100 million 
or more or adversely affect in a material way the economy, a sector of 
the economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities; (2) create a serious inconsistency or otherwise interfere 
with an action taken or planned by another agency; (3) materially alter 
the budgetary impact of entitlements, grants, user fees, or loan 
programs or the rights and obligations of recipients thereof; or (4) 
raise novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles set forth in the Executive 
Order.
    It has been determined that this rule is not a ``significant 
regulatory action'' under the terms of Executive Order 12866 and is 
therefore not subject to OMB review. This action affects only one 
chemical and in fact, reduces the burden on those facilities that 
handle IPDI in small quantities.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden. 
This final rule will relieve burden for some facilities that handle 
IPDI in small quantities. Currently, the threshold planning quantity 
for IPDI is 100 pounds. It is now being raised to 500 pounds. 
Therefore, we conclude that this action does not impose any new 
information collection burden, rather, it will relieve some burden.
    This rule will not provide a significant amount of burden 
reduction, however, the Office of Management and Budget (OMB) has 
previously approved the information collection requirements contained 
in the existing regulations 40 CFR Part 355 under the provisions of the 
Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB 
control number 2050-0092, (EPA ICR No. 1395.05). Copies of the ICR 
document(s) may be obtained from Susan Auby, by mail at U.S. 
Environmental Protection Agency, Collection Strategies Division (Mail 
Code 2822T), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, by 
email at [email protected], or by calling (202) 566-1672. A copy may 
also be downloaded off the internet at http://www.epa.gov/icr. Include 
the ICR and /or OMB number in any correspondence.
    Burden means the total time, effort, or financial resources 
expended by persons to generate, maintain, retain, or disclose or 
provide information to or for a Federal agency. This includes the time 
needed to review instructions; develop, acquire, install, and utilize 
technology and systems for the purposes of collecting, validating, and 
verifying information, processing and maintaining information, and 
disclosing and providing information; adjust the existing ways to 
comply with any previously applicable instructions and requirements; 
train personnel to be able to respond to a collection of information; 
search data sources; complete and review the collection of information; 
and transmit or otherwise disclose the information.
    An Agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA), as amended by the Small 
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 
601 et. seq, generally requires an agency to prepare a regulatory 
flexibility analysis of any rule subject to notice and comment 
rulemaking requirements under the Administrative Procedure Act or any 
other statute unless the agency certifies that the rule will not have a 
significant economic impact on a substantial number of small entities. 
Small entities include small businesses, small organizations, and small 
governmental jurisdictions.
    For purposes of assessing the impacts of today's rule on small 
entities, a small entity is defined as: (1) A small business that is 
defined by the Small Business Administration by category of business 
using North American Industrial Classification System (NAICS) and 
codified at 13 CFR 121.201; (2) a small governmental jurisdiction that 
is a government of a city, county, town, school district or special 
district with a population of less than 50,000; and (3) a small 
organization that is any not-for-profit enterprise which is 
independently owned and operated and is not dominant in its field.
    After considering the economic impacts of today's action on small 
entities, I certify that this action will not have a significant 
economic impact on a substantial number of small entities. This action 
will relieve some small entities handling IDPI in small quantities.
    In determining whether a rule has a significant economic impact on 
a substantial number of small entities, the impact of concern is any 
significant adverse economic impact on small entities, since the 
primary purpose of the regulatory flexibility analyses is to identify 
and address regulatory alternatives ``which minimize any significant 
economic impact of the proposed rule on small entities.'' 5 U.S.C. 603 
and 604. Thus, an agency may certify that a rule will not have a 
significant economic impact on a substantial number of small entities 
if the rule relieves regulatory burden, or otherwise has a positive 
economic effect on all of the small entities subject to the rule. The 
revised threshold for IDPI, which will raise it from 100 pounds to 500 
pounds, may relieve many small entities that handle this chemical in 
small amounts from the reporting requirement. We have therefore 
concluded that this rule will relieve regulatory burden for affected 
small entities.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, and tribal 
governments and the private sector. Under section 202 of the UMRA, EPA 
generally must prepare a written statement, including a cost-benefit 
analysis, for proposed and final rules with ``Federal mandates'' that 
may result in expenditures to State, local, and tribal governments, in 
the aggregate, or to the private sector, of $100 million or more in any 
one year. Before promulgating an EPA rule for which a written statement 
is needed, section 205 of the UMRA generally requires EPA to identify 
and consider a reasonable number of regulatory alternatives and adopt 
the least costly, most cost-effective or least burdensome alternative 
that achieves the objectives of the rule. The provisions of section 205 
do not apply when they are inconsistent with applicable law. Moreover, 
section 205 allows EPA to adopt an alternative other than the least 
costly, most cost-effective or least burdensome alternative if the 
Administrator publishes with the final rule an explanation why that 
alternative was not adopted. Before EPA establishes any regulatory 
requirements that may significantly or uniquely affect small 
governments, including tribal governments, it must have developed under 
section 203 of the UMRA a small government agency plan. The plan must

[[Page 52983]]

provide for notifying potentially affected small governments, enabling 
officials of affected small governments to have meaningful and timely 
input in the development of EPA regulatory proposals with significant 
Federal intergovernmental mandates, and informing, educating, and 
advising small governments on compliance with the regulatory 
requirements.
    EPA has determined that this rule does not contain a Federal 
mandate that may result in expenditures of $100 million or more for 
State, local, and tribal governments, in the aggregate, or the private 
sector in any one year. This rule will provide burden relief, and 
doesn't impose additional costs to State, local, or tribal governments, 
or to the private sector. Thus, today's rule is not subject to the 
requirements of sections 202 and 205 of the UMRA.
    EPA also has determined that this rule contains no regulatory 
requirements that might significantly or uniquely affect small 
governments. The rule will provide burden relief to regulated entities.

E. Executive Order 13132: Federalism

    Executive Order 13132, ``Federalism'' (64 FR 43255, August 10, 
1999), requires EPA to develop an accountable process to ensure 
``meaningful and timely input by state and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the states, on the relationship between the national 
government and the states, or on the distribution of power and 
responsibilities among the various levels of government.''
    This final rule does not have federalism implications. It will not 
have substantial direct effects on the states, on the relationship 
between the national government and the states, or on the distribution 
of power and responsibilities among the various levels of government, 
as specified in Executive Order 13132. This rule does not impose a 
substantial economic burden on state and local governments, nor would 
it restrict state and local governments from establishing other more 
stringent, regulations. Thus, Executive Order 13132 does not apply to 
this rule.
    The purpose of this rule is to correct the TPQ for IPDI based on 
EPA's existing methodology. This rule relieves some burden on the local 
governments in preparing emergency response plans since fewer 
facilities may be now subject to reporting this chemical. This action 
does not prevent any state governments from enforcing more stringent 
standards for this chemical.

F. Executive Order 13175: Consultation and Coordination with Indian 
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination 
with Indian Tribal Governments'' (65 FR 67249, November 6, 2000), 
requires EPA to develop ``an accountable process to ensure meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal government and Indian tribes.''
    This final rule does not have tribal implications. It will not have 
substantial direct effect on tribal governments, on the relationship 
between the Federal government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.
    The purpose of this rule is to correct the TPQ for IPDI based on 
EPA's existing methodology. This rule relieves some burden on tribal 
governments in preparing emergency response plans since fewer 
facilities may be now subject to reporting this chemical. This action 
does not prevent tribal governments from enforcing more stringent 
standards for this chemical.

G. Executive Order 13045: Protection of Children From Environmental 
Health & Safety Risks

    The Executive Order 13045, entitled ``Protection of Children from 
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 
1997), applies to any rule that: (1) Is determined to be ``economically 
significant'' as defined under Executive Order 12866, and (2) concerns 
an environmental health or safety risk that EPA has reason to believe 
may have a disproportionate effect on children. If the regulatory 
action meets both criteria, the Agency must evaluate the environmental 
health or safety effects of the planned rule on children; and explain 
why the planned regulation is preferable to other potentially effective 
and reasonably feasible alternatives considered by the Agency. This 
final rule is not subject to Executive Order 13045 because (a) it is 
not an economically significant regulatory action as defined by 
Executive Order 12866 and (b) the environmental health or safety risks 
addressed by this action do not have a disproportionate effect on 
children.
    EPA is not modifying its methodology for establishing threshold 
planning quantities. The Agency is correcting the TPQ for IPDI based on 
its existing methodology. Therefore, this action does not have a 
disproportionate effect on children. As previously described, the TPQ 
drives a reporting requirement; such reporting provides chemical hazard 
information for emergency preparedness and planning. Raising the TPQ 
for IPDI may result in less overall reporting information for IPDI. 
However, in the context of all information collected, IPDI information 
will be properly scaled to other hazards that may be present in a 
community allowing a community to properly focus its emergency 
preparedness and planning efforts as needed. Therefore, this action 
does not have a disproportionate effect on children.

H. Executive Order 13211 (Energy Effects)

    This rule is not subject to Executive Order 13211, ``Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use'' (66 FR 28355 (May 22, 2001)) because it is not a 
significant regulatory action under Executive Order 12866.

I. National Technology Transfer Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note), directs EPA to use voluntary consensus standards in its 
regulatory activities unless to do so would be inconsistent with 
applicable law or otherwise impractical. Voluntary consensus standards 
are technical standards (e.g., materials specifications, test methods, 
sampling procedures, business practices, etc.) that are developed or 
adopted by voluntary consensus standards bodies. The NTTAA requires EPA 
to provide Congress, through OMB, explanations when the Agency decides 
not to use available and applicable voluntary consensus standards.
    This final rule does not involve technical standards. EPA is 
establishing the correct TPQ for IPDI using existing methodologies. 
Therefore, EPA is not considering the use of any voluntary consensus 
standards.

[[Page 52984]]

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 requires that each Federal agency make 
achieving environmental justice part of its mission by identifying and 
addressing, as appropriate, disproportionately high and adverse human 
health or environmental effects of its programs, policies, and 
activities on minorities and low-income populations. In today's action, 
the Agency is correcting the TPQ for IPDI based on its existing 
methodology, thereby providing burden relief to those facilities that 
handle IPDI in small quantities. EPA is not changing its methodology 
for establishing threshold planning quantities. Any local effects must 
be considered on a case-by-case basis at local communities. State and 
local officials will continue to get information on this chemical from 
facilities, but can better focus on chemicals that are more hazardous. 
Therefore, this particular action will not have any impact on any 
minority or low-income populations.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. A Major rule cannot 
take effect until 60 days after it is published in the Federal 
Register. This action is not a ``major rule'' as defined by 5 U.S.C. 
804(2). This rule will be effective October 8, 2003.

List of Subjects in 40 CFR Part 355

    Environmental Protection, Air pollution control, Chemicals, 
Hazardous substances, Reporting and recordkeeping requirements, 
Superfund.

    Dated: September 2, 2003.
Marianne Lamont Horinko,
Acting Administrator.

0
For the reasons set out in the preamble, part 355 of title 40 of the 
Code of Federal Regulations is amended as follows:

PART 355--EMERGENCY PLANNING AND NOTIFICATION

0
1. The authority citation for part 355 continues to read as follows:

    Authority: 42 U.S.C. 11002, 11004, and 11048.

Appendix A--[Amended]

0
2. In Appendix A the table is amended by revising the entry for CAS No. 
``4098-71-9'' (chemical name--Isophorone Diisocyanate) to read as 
follows:

   Appendix A to Part 355--The List of Extremely Hazardous Substances and Their Threshold Planning Quantities
                                              [Alphabetical Order]
----------------------------------------------------------------------------------------------------------------
                                                                                Reportable         Threshold
               CAS No.                     Chemical name          Notes         quantity*      planning quantity
                                                                                 (pounds)           (pounds)
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
4098-71-9...........................  Isophorone              ............                100                500
                                       Diisocyanate..
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------


Appendix B--[Amended]0
3. In Appendix B the table is amended by revising the entry for CAS No. 
``4098--71-9'' (chemical name--isophorone diisocyanate) to read as 
follows:

   Appendix B to Part 355--The List of Extremely Hazardous Substances and Their Threshold Planning Quantities
                                                 [CAS No. Order]
----------------------------------------------------------------------------------------------------------------
                                                                                Reportable         Threshold
               CAS No.                     Chemical name          Notes         quantity*      planning quantity
                                                                                 (pounds)           (pounds)
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
4098-71-9...........................  Isophorone              ............                100                500
                                       Diisocyanate..
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 03-22770 Filed 9-5-03; 8:45 am]
BILLING CODE 6560-50-U