[Federal Register Volume 71, Number 245 (Thursday, December 21, 2006)]
[Rules and Regulations]
[Pages 76603-76615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21869]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 63
[EPA-HQ-OAR-2005-00475; FRL-8259-6]
RIN 2060-AK14
National Emission Standards for Organic Hazardous Air Pollutants
From the Synthetic Organic Chemical Manufacturing Industry
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: In 1994, EPA promulgated national emission standards for
hazardous air pollutants (NESHAP) for the synthetic organic chemical
manufacturing industry. This rule is commonly known as the hazardous
organic NESHAP (HON) and established maximum achievable control
technology standards to regulate the emissions of hazardous air
pollutants from production processes that are located at major sources.
The Clean Air Act directs EPA to assess the risk remaining
(residual risk) after the application of the maximum achievable control
technology standards and to promulgate additional standards if required
to provide an ample margin of safety to protect public health or
prevent an adverse environmental effect. The Clean Air Act also
requires us to review and revise maximum achievable control technology
standards, as necessary, every 8 years, taking into account
developments in practices, processes, and control technologies that
have occurred during that time.
On June 14, 2006, EPA proposed two options regarding whether to
amend the current emission standards for synthetic organic chemical
manufacturing industry units. This action finalizes one of those
options, and reflects our decision not to impose further controls and
not to revise the existing standards based on the residual risk and
technology review. It also amends the existing regulations in certain
aspects.
DATES: This final rule is effective on December 21, 2006.
ADDRESSES: Docket: EPA has established a docket for the final rule
under Docket ID No. EPA-HQ-OAR-2005-0475. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, e.g., confidential
business information 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 at http://www.regulations.gov or in
hard copy at the Air and Radiation Docket, EPA West, Room B-102, 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.
Note: The EPA Docket Center suffered damage due to flooding
during the last week of June 2006. The Docket Center is continuing
to operate. However, during the cleanup, there will be temporary
changes to Docket Center telephone numbers, addresses, and hours of
operation for people who wish to make hand deliveries or visit the
Public Reading Room to view documents. Consult EPA's Federal
Register notice at 71 FR 38147 (July 5, 2006) or the EPA Web site at
http://www.epa.gov/epahome/dockets.htm for current information on
docket operations, locations, and telephone numbers. The Docket
Center's mailing address for U.S. mail and the procedure for
submitting comments to www.regulations.gov are not affected by the
flooding and will remain the same.
FOR FURTHER INFORMATION CONTACT: For further information contact Mr.
Randy McDonald, U.S. EPA, Office of Air Quality Planning and Standards,
Sector Policies and Programs Division, Coatings and Chemicals Group
(E143-01), Research Triangle Park, NC 27711, telephone (919)541-5402,
fax (919) 541-0246, e-mail [email protected].
SUPPLEMENTARY INFORMATION: Regulated Entities. Categories and entities
potentially regulated by the final rule are synthetic organic chemical
manufacturing industry (SOCMI) facilities that are major sources of
hazardous air pollutant (HAP)
[[Page 76604]]
emissions. The final rule affects the following categories of sources:
------------------------------------------------------------------------
NAICS* Examples of potentially
Category Code regulated entities
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Industry..................... 325 Chemical manufacturing
facilities.
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* North American Industry Classification System.
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by the
final rule.
World Wide Web (WWW). In addition to being available in the docket,
electronic copies of the final rule are available on the WWW through
the Technology Transfer Network Web site (TTN). Following signature,
EPA posted a copy of the final rule on the TTN's policy and guidance
page for newly proposed or promulgated rules at http://www.epa.gov/ttn/oarpg. The TTN provides information and technology exchange in various
areas of air pollution control.
Judicial Review. Under Clean Air Act (CAA) section 307(b)(1),
judicial review of this final rulemaking is available only by filing a
petition for review in the United States Court of Appeals for the
District of Columbia Circuit by February 20, 2007. Under CAA section
307(d)(7)(B), only an objection to the final rulemaking that was raised
with reasonable specificity during the period for public comment may be
raised during judicial review. Moreover, under CAA section 307(b)(2),
the rule's requirements may not be challenged separately in any civil
or criminal proceedings brought by EPA to enforce these requirements.
Section 307(d)(7)(B) of the CAA further provides a mechanism for us
to convene a proceeding for reconsideration, ``[i]f the person raising
an objection can demonstrate to the EPA that it was impracticable to
raise such objection within [the period for public comment] or if the
grounds for such objection arose after the period for public comment
(but within the time specified for judicial review) and if such
objection is of central relevance to the outcome of the rule.'' Any
person seeking to make such a demonstration to us should submit a
Petition for Reconsideration to the Office of the Administrator, U.S.
EPA, Room 3000, Ariel Rios Building, 1200 Pennsylvania Ave., NW,
Washington, DC 20460, with a copy to both the person(s) listed in the
preceding FOR FURTHER INFORMATION CONTACT section, and the Associate
General Counsel for the Air and Radiation Law Office, Office of General
Counsel (Mail Code 2344A), U.S. EPA, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
Organization of this Document. This preamble is organized as
follows:
I. Background Information
A. What Is the Statutory Authority for These Actions?
B. What Did We Propose?
II. Risk and Technology Review
A. Final Decision
B. Summary of Changes to the Rule
III. Responses to Significant Comments
A. Data Collection
B. Risk Determination
C. Administrative Requirements
D. Impacts Estimation
E. Clarification Changes
IV. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility
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 and Safety Risks
H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution or Use
I. National Technology Transfer Advancement Act
J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
K. Congressional Review Act
I. Background Information
A. What is the statutory authority for these actions?
Section 112 of the CAA establishes a two-stage regulatory process
to address emissions of HAP from stationary sources. In the first
stage, after EPA has identified categories of sources emitting one or
more of the HAP listed in CAA section 112(b), CAA section 112(d) calls
for us to promulgate national performance or technology-based emission
standards for those sources. For ``major sources'' that emit or have
the potential to emit any single HAP at a rate of 10 tons or more per
year or any combination of HAP at a rate of 25 tons or more per year,
these technology-based standards must reflect the maximum reductions of
HAP achievable (after considering cost, energy requirements, and non-
air quality health and environmental impacts) and are commonly referred
to as maximum achievable control technology (MACT) standards. We first
published the MACT standard for SOCMI on April 22, 1994, at 59 FR 19402
(codified at 40 CFR part 63, subparts F, G, H, and I). EPA is then
required to review these technology-based standards and to revise them
``as necessary, taking into account developments in practices,
processes, and control technologies,'' no less frequently than every 8
years, under CAA section 112(d)(6).
The second stage in standard-setting is described in CAA section
112(f). This provision requires, first, that EPA prepare a Report to
Congress discussing (among other things) methods of calculating risk
posed (or potentially posed) by sources after implementation of the
MACT standards, the public health significance of those risks, the
means and costs of controlling them, actual health effects to persons
in proximity to emitting sources, and recommendations as to legislation
regarding such remaining risk. EPA prepared and submitted this report
(Residual Risk Report to Congress, EPA-453/R-99-001) in March 1999. The
Congress did not act on any of the recommendations in the report,
thereby triggering the second stage of the standard-setting process,
the residual risk phase.
CAA Section 112(f)(2) requires us to determine, for each CAA
section 112(d) source category, whether the MACT standards protect
public health with an ample margin of safety. If the MACT standards for
HAP ``classified as a known, probable, or possible human carcinogen do
not reduce lifetime cancer risks to the individual most exposed to
emissions from a source in the category or subcategory to less than 1-
in-1 million,'' EPA must promulgate residual risk standards for the
source category (or subcategory) as necessary to provide an ample
margin of safety to protect public health. EPA may also adopt more
stringent standards, if necessary, to prevent an adverse environmental
effect (defined in CAA section 112(a)(7) as ``any significant and
widespread adverse effect * * * to wildlife, aquatic life, or natural
resources * * *.''), after considering cost, energy, safety, and other
relevant factors.
B. What did we propose?
On June 14, 2006 (71 FR 34422), we proposed two options regarding
whether to revise the current emission standards for new and existing
SOCMI process units. The first proposed option would have imposed no
further controls, based on a proposed finding that the existing
standards protect public health with an ample margin of safety and
prevent adverse environmental effects. Moreover, under the first
option, we proposed that no further tightening of current standards was
``necessary'' in
[[Page 76605]]
light of developments in practices, processes, and control
technologies.
The second proposed option would have required further reductions
of organic HAP at certain process units, based on a proposed finding
that additional controls were reasonable in order to protect public
health with an ample margin of safety. This option was also based on a
proposed finding that, in order to further reduce risks, tightening of
current standards was ``necessary'' after taking into account
developments in practices, processes, and control technologies. The
second option would have applied additional controls for equipment
leaks and controlled some storage vessels and process vents that are
not required to be controlled under the current rule. The proposed
changes under Option 2 are summarized in the table below:
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Emission source Proposed changes to standards
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Storage vessels....................... A Group 1 storage vessel also
includes storage vessels that
store one or more HAP listed in
table 38 to subpart G of part
63, and has a combined HAP
emission rate greater than 4.54
megagrams per year (5.0 tons
HAP per year) on a rolling 12-
month average.
Process vents......................... A Group 1 process vent also
includes process vents for
which the vent stream emits one
or more HAP listed in table 38
to subpart G of part 63, and
the total resource
effectiveness index value is
less than or equal to 4.0.
Equipment leaks....................... For chemical manufacturing
process units (CMPU) containing
at least one HAP listed in
table 38 to subpart G of part
63, monthly monitoring of
equipment components is
required until the process unit
has fewer than 0.5 percent
leaking valves in gas/vapor
service and in light liquid
service.
------------------------------------------------------------------------
II. Risk and Technology Review
A. Final Decision
We conclude in this rulemaking that there is no need to revise the
HON rule under the provisions of either section 112(f) or 112(d)(6) of
the CAA. This conclusion essentially reflects our decision to select
Option 1 from the proposal, except for certain minor technical
amendments we are adopting that are discussed later.
We are adopting no changes to the current HON rule under CAA
section 112(f) because the current level of control called for by the
existing MACT both reduces HAP emissions to levels that present an
acceptable level of risk and protects public health with an ample
margin of safety. The finding regarding an ``ample margin of safety''
is based on a consideration of the additional costs of further control
(as represented by Option 2) and the relatively small reductions in
health risks that are achieved by that alternative.
As explained at proposal, we judge that the level of risk from the
current HON rule is acceptable for the following reasons. The maximum
individual lifetime cancer risk is estimated to be 100-in-1 million,
and this level of risk occurs at only two facilities. There are no
people with estimated cancer risks greater than 100-in-1 million
resulting from exposure to HON HAP emissions, which is the
presumptively acceptable level of maximum individual lifetime cancer
risk under the 1989 Benzene NESHAP criteria. The HON process units at
32 facilities are estimated to pose cancer risks greater than 10-in-1
million, with 9,000 people estimated to be exposed in this risk range.
The HON process units at the remaining 206 facilities are estimated to
pose cancer risks of 10-in-1 million or less. For the exposed
population, total annual cancer incidence is estimated at 0.14 cases
per year. The Hazard Index (HI) values (representing long-term
noncancer public health risks) barely exceed 1, with only 20 people
estimated to be exposed to HI levels greater than 1. We also found
minimal concern for noncancer effects from short-term inhalation
exposures from HAP. The lifetime cancer risk and noncancer adverse
health effects estimated from multipathway exposure are also well below
levels generally held to be of concern. Finally, after considering
costs, energy, safety, and other relevant factors, it is not necessary
to tighten HON requirements in order to prevent adverse environmental
effects, or to account for developments in practices, processes, and
control technologies.
In determining that the current HON rule protects public health
with an ample margin of safety, we have determined that the estimated
annual costs of Option 2 ($6 million per year) would be unreasonable
given the minor associated improvements in health risks. Baseline
cancer incidence under the current HON rule is estimated at 0.14 cases
per year. Proposed Option 2 would reduce incidence by about 0.05 cases
per year. Statistically, this level of risk reduction means that Option
2 would prevent one cancer case every 20 years. At proposal we
estimated costs to be $13 million per year for Option 2. Based on
public comments, we revised one of the Option 2 control requirements
and the costing procedure for equipment leaks and this resulted in a
revised cost estimate $6 million per year. Even at the $6 million per
year cost, we consider the cost of Option 2 to be unreasonable given
the level of incidence reduction achieved. The changes in the
distribution of risks do not warrant the additional costs. The maximum
individual cancer risk under Option 2 would be reduced from 100-in-1
million to 60-in-1 million. The cancer risks for 450,000 people would
be shifted to levels below 1-in-1 million. Further, changes in the
distribution of risk--that is, the aggregate change in risk across the
population--reduces risk by only 0.05 cancer cases per year. This
result suggests that Option 2 would yield very small changes in
individual risk for most of the affected population. For this reason,
the estimates of the shift in risk distribution do not serve as
particularly effective measures of the change in health risk. Finally,
the maximum HI is barely above 1.0 and would be reduced from above 1.0
to below 1.0 for only 20 people. We conclude that this degree of
additional public health protection is not warranted in light of the
costs to industry of compliance with proposed Option 2. Consequently,
we have determined that it is not reasonable to impose any additional
controls to provide an ample margin of safety to protect public health.
In the technology review, we did not identify any significant
developments in practices, processes, or control technologies since
promulgation of the original standards in 1994. We concluded that
imposing additional controls under proposed Option 2 would achieve, at
best, minimal emission and risk reductions. Option 2 would reduce
organic HAP emissions by 1,700 tons per year, reduce cancer incidence
by 0.05 cases per year, and reduce HI below 1 for about 20 individuals.
We estimate that no one is currently exposed to emissions from HON
sources causing cancer risks exceeding 100-in-1 million, the
presumptively acceptable level for individual lifetime cancer risk
under the Benzene NESHAP. (The relationship
[[Page 76606]]
between residual risk and the CAA section 112(d)(6) review is explained
in our proposal at 72 FR 34436.) Thus, because of the lack of any
significant developments in practices, processes, or technologies, and
the limited effect in reducing public health risk, we find that
additional controls are not warranted under CAA section 112(d)(6).
B. Summary of Changes to the Rule
While we are making no changes to the control requirements of the
existing standards based on the residual risk and technology review, we
are publishing three technical amendments under CAA section 112(d)(2)
designed to clarify provisions of the existing rule and provide for
effective implementation. At proposal, we solicited comments on a list
of rule clarifications. After considering public comments, we have
decided not to adopt some of the proposed changes at this time. We may
consider some of these proposed changes again in the future, in which
case we intend to provide an additional opportunity to comment on them.
However, we are finalizing one minor change on which we solicited
comments. We are also making two minor changes for which we did not
solicit comments but which were recommended by commenters. We are also
clarifying in this preamble that liquid streams generated from control
devices (e.g., scrubber effluent) are wastewater. No rule changes are
necessary for this clarification.
1. Group Status Changes for Wastewater
The revised rule clarifies the requirement to redetermine Group
status for wastewater streams if process or operational changes occur
that could reasonably be expected to change the wastewater stream from
a Group 2 to a Group 1 stream. Examples of such process changes
include, but are not limited to, changes in production capacity,
production rate, feedstock type, or catalyst type; or whenever there is
replacement, removal, or addition of recovery equipment. Although 40
CFR 63.100(m) generally applies to Group 2 wastewater streams becoming
Group 1, this change clarifies requirements for redetermining group
status for wastewater by including provisions analogous to those in 40
CFR 63.115(e), which requires redetermination of total resource
effectiveness index value (TRE) for process vents due to process or
operational changes.
2. Removal of Methyl Ethyl Ketone (MEK) from HON Tables
In the final rule we have removed MEK from Tables 2 and 4 of 40 CFR
part 63, subpart F and tables 9, 34, and 36 of 40 CFR part 63, subpart
G. MEK was removed from the HAP list on December 19, 2005 (70 FR
75047). At that time, MEK was not removed from various applicability
tables in the HON, 40 CFR part 63, subparts F and G.
3. Vapor Balancing for Storage Tanks
In the final rule we have decided to waive all notification and
reporting requirements for owners or operators of facilities where
railcars, tank trucks, or barges, which are part of the vapor balancing
control option, are reloaded or cleaned. We are also allowing off-site
reloading and cleaning operations to comply with monitoring,
recordkeeping, and reporting provisions of any other applicable 40 CFR
part 63 standards in lieu of the monitoring, recordkeeping, and
reporting in the HON. These provisions have been added to other MACT
standards because the vapor balancing provisions provide owners and
operators flexibility in meeting the requirements of the MACT standards
without sacrificing the level of emission reductions being achieved.
Further, making these changes provide consistency between similar
emission sources being controlled under similar rules.
These amendments reflect a logical outgrowth of our proposed rule,
and are reasonable decisions made in response to public comments we
received regarding these issues.
III. Responses to Significant Comments
The proposal provided a 60-day comment period ending August 14,
2006. We received comments from 34 commenters. Commenters included
State agencies, industry, industry trade groups, environmental groups,
and individuals. We have summarized the significant comments below. A
complete summary of comments and our responses can be found in the
public docket for the promulgated rule, EPA-HQ-OAR-2005-0475.
A. Data Collection
Comment: One commenter stated that a major flaw in the risk
assessment is that EPA failed to use its CAA section 114 authority to
collect data for the risk assessment and, instead, used ``voluntary,
fragmentary, 7-year-old industry-submitted data from well under half of
the affected facilities.'' The commenter stated that the 1999 Residual
Risk Report to Congress emphasizes the need for site-specific data for
more refined assessments, and that EPA has not collected such data in
the risk assessment for the HON. The commenter stated that the purpose
of the risk assessment was to determine the residual risk from SOCMI
facilities, and that the data EPA used to perform the assessment was
not of the type and quality to achieve that objective.
Response: The CAA does not specify the type of data, or the method
of acquiring it, that EPA must use for conducting residual risk
assessments under CAA section 112(f). EPA can use data other than those
gained through its CAA section 114 authority, if doing so enables the
agency to determine the remaining risks presented after application of
MACT standards. At the time EPA was considering options for data
collection, the industry trade association (American Chemistry Council)
volunteered and prepared questionnaires to member companies. EPA
reviewed the questionnaire and determined that the information
requested by it would greatly facilitate our conducting a residual risk
assessment. The data received through the questionnaire represented a
significant fraction of the facilities in the source category
(approximately 44 percent), and include site-specific data on emissions
sources, locations, and release parameters. Where emission release
parameter data were missing, EPA used environmentally protective
defaults in the modeling. While it is true that the data are now 7
years old, a significant amount of time was needed to collect and
analyze the data, run the models, analyze the results, and prepare the
rulemaking package. Moreover, the mere age of the data does not
necessarily affect its utility for assessing whether sources that have
achieved compliance with MACT continue to present risks of concern,
given that the essential question addressed by our assessment is
whether the MACT controls themselves are adequately protective of
public health with an ample margin of safety.
Comment: One commenter stated that EPA has performed no analysis to
determine that the industry data used in the risk assessment are
representative of the source category as a whole. The commenter stated
that for EPA to adequately satisfy CAA section 112(f), it must be able
to accurately identify the risk associated with the most exposed
individual and accurately estimate risk more generally from sources
within the source category. The commenter stated that, to do this, EPA
must have sufficient data regarding all of the important factors for
estimating risk (including size, quantity of emissions, the specific
characteristics of emission points, proximity, and population density
of surrounding communities, important meteorological and
[[Page 76607]]
topological data, co-located emission sources, ambient background
levels, etc.). The commenter stated that the factor of 2.3 that EPA
used to scale up the population risk from the assessed facilities to
the entire source category is arbitrary and unreasonable because it
assumes constant population density.
Response: The data used in the assessment were obtained from all
responses to the industry questionnaire, and include site-specific data
on emissions sources, locations, and release parameters. The data
represent a significant fraction of the category (approximately 44
percent), and include sources with high and low emissions, sources that
are geographically proportional to the entire source category, and
sources that emit nearly all organic HAP thought to be emitted from the
category.
While the emissions data obtained through the industry
questionnaire cannot be proven to be proportional to the emissions from
the entire source category, EPA does have whole-facility emissions data
for 226 facilities (the entire source category is estimated at 238
facilities) in the National Emissions Inventory (NEI), and we performed
a screening-level risk assessment using these data to determine if
there were HON facilities posing greater public health risks than those
included in the industry data. Although the NEI data were for the whole
facility (and not just the HON emission points), we used NEI data codes
(MACT codes, Standard Industrial Classification codes, and Source
Classification Codes) to judge whether risks estimated using the NEI
data could be attributed to the HON source category. We found that the
highest risks from using the NEI data were of the same order of
magnitude as those estimated using the industry data. Based on this
general corroboration with the NEI data, we concluded that the industry
data were the most detailed and comprehensive data available that were
specific to the source category, and that the data were appropriate for
use in conducting the residual risk assessment.
EPA did use a factor of 2.3 to estimate population risk associated
with facilities not included in the industry data. This factor is
simply the ratio of the total number of HON facilities to the number of
facilities in the industry data, and reflects our expectation, based on
further comparison to the NEI data, that on average, the population
densities around the facilities not in the industry data are similar to
the densities around the facilities that were in the industry data. We
estimate that there are 61.6 million people living within the 50-
kilometer modeling radius of the 105 HON facilities included in the
industry data. An estimated 82.8 million people live within the 50-
kilometer modeling radius of the 226 HON facilities modeled using the
NEI data. Accordingly, the sources in the industry-supplied data are
located near 75 percent of the total exposed population, but represent
44 percent of the total number of facilities in the industry. This
comparison indicates that many of the facilities not in the industry
data are located in less densely populated areas or in the same areas
as the facilities included in the industry data. Therefore, the
population densities around the modeled facilities appear to be
representative.
In the risk assessment, EPA showed that facilities with overlapping
modeling domains (facility ``clusters'') did not lead to significantly
higher estimated risks to the individual most exposed because such
risks are generally driven by the nearest facility. However, facility
clusters did increase the numbers of individuals within certain cancer
risk ranges. Although the total population around all facilities in the
source category is not a factor of 2.3 greater than the total
population around the facilities in the industry data, the additional
facilities would increase the risks to some of the same segments of the
population, resulting in higher risk to individuals in the population.
B. Risk Determination
Comment: One commenter believed that EPA has misinterpreted the CAA
by adopting the 1989 Benzene two-step framework to set residual risk
standards under the 1990 CAA. The commenter concluded that the proper
interpretation is that CAA section 112(f)(2)(A) specifies 1-in-1
million as a bright line and mandates promulgation of standards to
reach at least this level of health protection. The commenter believed
that CAA section 112(f)(2)(B) merely leaves standing, those relevant
rules that were promulgated under section 112 as it existed prior to
the 1990 CAA. The commenter disagreed with EPA's position that
Congressional inaction ratifies EPA's interpretation of CAA section
112(f)(2)(B). The commenter believed that Congressional failure to
respond to the EPA Report to Congress, which provided notification of
the intent to utilize the 1989 Benzene two-step approach, does not
justify overriding the plain statutory language of CAA section 112(f).
Response: We disagree with the commenter. Our policy on using the
Benzene NESHAP for implementing CAA section 112(f) has been fully
explained in the Coke Oven Batteries NESHAP (see 70 FR 19992, April 15,
2005) and the Residual Risk Report to Congress, and our approach here
is fully consistent with our prior practice. The commenter's argument
that the statute requires CAA section 112(f) residual risk standards to
reduce cancer risk to the most exposed individual to less than 1-in-1
million lacks a basis in the statutory text or in policy. CAA Section
112(f)(2)(A), in stating that EPA is to conduct residual risk
rulemaking if the ``lifetime excess cancer risk to the individual most
exposed to emissions from a source in a category or subcategory'' is
greater than 1-in-1 million, does not establish what the level of the
standard must be other than to require them to ``provide an ample
margin of safety to protect public health in accordance with this
section (as in effect before the date of enactment of the CAA
Amendments of 1990) [* * *].'' Read in light of CAA section
112(f)(2)(B)'s express preservation of EPA's pre-enactment
interpretation of CAA section 112, Congress clearly preserved EPA's
ability to apply the same two-step formulation established by the
Benzene NESHAP in making future ``ample margin of safety''
determinations under CAA section 112(f)(2).
Under that test, there is no single risk level establishing what
constitutes an ample margin of safety. Rather, the Benzene NESHAP
approach codified in CAA sections 112(f)(2)(A) and (B) is deliberately
flexible, requiring consideration of a range of factors (among them
estimates of quantitative risk, incidence, and numbers of exposed
persons within various risk ranges; scientific uncertainties; and
weight of evidence) when determining acceptability of risk (the first
step in the ample margin of safety determination (54 FR 38045,
September 14, 1989). Determination of an ample margin of safety, the
second step in the process, requires further consideration of these
factors, plus consideration of technical feasibility, cost, economic
impact, and other factors (54 FR 38046, September 14, 1989). As we
stated in our ``Residual Risk Report to Congress'' (EPA-453/R-99-001)
issued under CAA section 112(f)(1), we do not consider the 1-in-1
million individual cancer risk level as a ``bright line'' mandated
level of protection for establishing residual risk standards, but
rather as a trigger point to evaluate whether additional reductions are
necessary to provide an ample margin of safety to protect public
health. This interpretation is supported by the language in the
preamble to the Benzene NESHAP, which was
[[Page 76608]]
incorporated by Congress in CAA sections 112(f)(2)(A) and (B).
The Report to Congress was intended, among other things, to explain
how EPA would implement CAA section 112(f) by investigating the methods
available for assessing public health risks after the technology-based
standards were applied and explaining any uncertainties in the methods.
Congress also asked us to make recommendations for changes to the CAA
section 112(f) as a result of the investigation. A plain reading of the
CAA section 112(f)(2)(A) indicates that if, based on the report,
Congress judged that residual risk standards were unnecessary or that
the analytical methods for implementing the provisions were inadequate,
then Congress would enact revisions to CAA section 112(f). The choice
by Congress not to respond to the report clearly indicates that we
should proceed with our general approach as explained in our Report to
Congress.
We consequently believe that the commenter's bright line approach
is not supported by the statute, and is incorrect as a matter of law.
It is true that the Senate version of CAA section 112(f) mandated
elimination of lifetime risks of carcinogenic effects greater than 1-
in-10 thousand to the individual in the population most exposed to
emissions of a carcinogen. (See ``A Legislative History of the Clean
Air Act Amendments of 1990,'' pages 7598 and 8518.) However, this
version of the legislation was not adopted. We believe that the
rejected Senate version of CAA section 112(f) shows that Congress
considered mandating a level of risk reduction and chose not to do so.
In any event, EPA has concluded that the flexible approach to risk
acceptability and ample margin of safety set forth in the Benzene
NESHAP is reasonable and appropriate in light of the complex judgments
EPA must make under CAA section 112(f).
Comment: One commenter argued that CAA section 112(f)(2)(A) very
clearly prohibits using cost as a consideration for standards
promulgated to provide an ample margin of safety to protect public
health. CAA Section 112(f)(2)(A) directs EPA to promulgate standards in
order to provide an ample margin of safety to protect public health or
to prevent, taking into consideration costs, energy, safety, and other
relevant factors, an adverse environmental effect. The commenter
maintained that this construction allows cost as a consideration only
for standards designed to prevent an adverse environmental effect where
such standards are more stringent than necessary to protect human
health with an ample margin of safety. As part of their argument, the
commenter cited the Supreme Court decision in American Trucking
Associations v. Whitman (2001), which addressed ambient air quality
standards established under section 109 of the CAA, as providing
precedent that cost cannot be considered in developing regulations to
protect public health with a margin of safety. The commenter claimed
that this court decision abrogated the District of Columbia Circuit
decision on Vinyl Chloride, upon which the Benzene two-step policy is
based. They also pointed out that the 1990 CAA removed the statutory
language that Vinyl Chloride relied upon heavily. The commenter pointed
out that unlike the previous CAA, section 112(f) of the 1990 CAA does
not contain the phrase ``* * * set the standard at the level which in
[the Administrator's] judgment provides an ample margin of safety to
protect public health.'' The commenter claimed that exclusion of the
specific requirement to use judgment invalidates the basis of Vinyl
Chloride.
Response: The clear reading of CAA section 112(f) allows us to take
cost into consideration within the context of the two-step policy of
the 1989 Benzene NESHAP. The stipulation in CAA section 112(f)(2)(A)
that costs, energy, safety, and other factors can be taken into
consideration in setting standards to prevent an adverse environmental
effect does not mean that costs cannot be taken into consideration in
determining standards to protect public health. To the contrary, CAA
section 112(f)(2)(A) states that residual risk standards are to provide
an ample margin of safety to protect public health ``in accordance with
this section (as in effect before the date of enactment of the Clean
Air Act Amendments of 1990).'' This formulation, coupled with CAA
section 112(f)(2)(B), which states that nothing in CAA section
112(f)(2)(A) or any other part of CAA section 112 shall be construed as
affecting the EPA's interpretation of this section as set forth in the
preamble to the 1989 Benzene NESHAP, reflects Congress' endorsement of
the Benzene NESHAP approach, including the use of costs in determining
an ample margin of safety.
The court decision cited by the commenter, American Trucking
Association v. Whitman, has no relevance to decisions on ample margin
of safety made under section 112 of the CAA. That case addressed the
consideration of cost in the context of setting national ambient air
quality standards under CAA section 109. The American Trucking
Association v. Whitman decision does not specifically address, nor does
it apply (nor could it have, as a matter of jurisdiction, since the
court was not faced with an issue requiring a ruling on an
interpretation of CAA section 112), to the different statutory
requirements for regulating HAP under CAA section 112 or to any prior
judicial precedent interpreting CAA section 112. Also, we do not read
the 1990 CAA as overturning or otherwise disapproving of the court's
decision in Vinyl Chloride. By directing us under CAA sections
112(f)(2)(A) and (B) to follow the 1989 Benzene NESHAP policy, the 1990
CAA requires the Administrator to use judgment both in establishing
risk levels that constitute a safe level of exposure and in balancing
costs against remaining risks for determining an ample margin of
safety. Therefore, by eliminating the wording in CAA section
112(f)(2)(A) to use ``judgment,'' Congress eliminated a redundant
specification and did not remove the legal basis of the Vinyl Chloride
decision.
Comment: Several commenters contended that revising the HON
pursuant to CAA section 112(d)(6) is not necessary and not justified.
The commenters stated that EPA's Option 2 would revise the MACT beyond-
the-floor decisions, that emission reductions to be gained from Option
2 are significantly overstated, and that the emission reduction does
not justify the cost. Several commenters noted that Option 2
alternatives do not represent any ``developments in practices,
processes, and control technologies'' but rather simply reflect an
apparent decision by EPA that higher cost options that were rejected in
the original beyond-the-floor analysis are now somehow acceptable.
Response: We do not agree that in reviewing a standard under CAA
section 112(d)(6), the CAA mandates that only the question of whether
newly developed emission control measures have been identified since
the publication of the MACT standards be addressed. CAA Section
112(d)(6) requires that EPA review and revise standards ``as
necessary.'' As we explain later, the instruction to revise ``as
necessary'' indicates that EPA should use judgment in this regulatory
decision, and is not precluded from considering additional relevant
factors, such as risk and the evolution of costs of previously
considered measures. At the time of a MACT determination, the beyond-
the-floor decision is made without knowledge of the level of risks
posed by an industry. In the subsequent reviews of the standards, we
have substantial discretion in weighing all of the relevant factors,
including all
[[Page 76609]]
available control measures that are more stringent than that required
by the current NESHAP, emission reductions, public health risk impacts,
costs, and any other relevant factors to determine what further
controls, if any, are necessary.
Comment: Several commenters contended that the application of CAA
section 112(d)(6) should incorporate the framework of CAA section
112(f)(2) because this approach would require the Administrator to
weigh the potential for future risk reduction under CAA section
112(d)(6) against the cost of that reduction in the same manner as set
forth in the second step of the 1989 Benzene NESHAP rule. One commenter
added that technology reviews that focus solely on the cost-per-ton of
additional emission controls and do not consider the risk reduction
potential could result in the imposition of technology controls that
yield very little, if any, benefit. Another commenter stated that when
a MACT standard achieves protection of public health with an ample
margin of safety and prevents adverse environmental effects, as is the
case with the HON, no further revisions are ``necessary'' even if there
have been developments in control technologies. The commenter believed
that a determination of ample margin of safety and no adverse
environmental effects alone is sufficient to determine that revision of
the standard is not necessary under CAA section 112(d)(6). The
commenter supported EPA's position that risk benefits are appropriate
to consider under the CAA section 112(d)(6) decision.
Another commenter rejected EPA's interpretation that the term
``revise as necessary'' allows EPA to import into its 8-year evaluation
the consideration of cost and risk. The commenter maintained that
emission standards adopted under CAA section 112(d)(2) themselves were
the product of a technology-driven evaluation that did not incorporate
cost as a factor in the initial stages, and did not permit
consideration of risk at all. The commenter continued that EPA has
illegally substituted a risk/cost analysis for the requirement to
perform an analysis of the technical feasibility of emission controls
to establish the level of control of the best performing HON sources.
Response: We have addressed the relationship between CAA sections
112(f) and 112(d) in other recent rulemakings, as well as in the
proposal for today's final rule. See, e.g., our response to comments
document for the Dry Cleaning Facilities Residual Risk Rule (71 FR
42727, July 27, 2006) (EPA's Summary of Public Comments and Responses
to the Proposed Rule is located at docket no. EPA-HQ-OAR-2005-0155). As
we explained in our proposal (see 71 FR 34436, June 14, 2006), the
findings that underlie a CAA section 112(f) risk determination will
often be key factors in making any subsequent CAA section 112(d)(6)
technology review determinations. While our action today makes no
changes to control requirements under the HON and it is, therefore, not
necessary to respond to their individual points, we disagree with the
commenters who state that a determination under CAA section 112(f) of
an ample margin of safety and no adverse environmental effects alone
will, in all cases, necessarily cause us to determine that a revision
is not necessary under CAA section 112(d)(6). Our decision today should
not be viewed as a departure from our general view, articulated in the
proposal, that in some cases, even if risk factors remain the same from
one round of CAA section 112(d)(6) review to another, changes in costs
of or in the availability of control technology may be sufficient to
alter a previous conclusion about whether to impose further controls.
In response to the commenter who claimed we may not consider risks
or costs at all under CAA section 112(d)(6), we continue to interpret
the use of the phrase ``as necessary'' in that section as conferring
discretion on the agency to exercise its judgment as to what factors
may drive an evaluation of available practices, processes, and control
technologies. The ambiguous term ``as necessary'' inherently requires
an EPA comparison between control measures and some goal or end. As the
first rounds of both CAA section 112(f) residual risk and CAA section
112(d) technology review occur 8 years following MACT, it is reasonable
to interpret these duties as being compatible with and informative of
each other, and for the ultimate goal of revising standards as needed
to protect public health with an ample margin of safety as influencing
what we determine is generally ``necessary,'' in terms of whether to
impose further technological controls under CAA section 112(d)(6).
Comment: One commenter contended that, for residual risk
assessments, EPA may not rely on actual emissions, which represents
``over-control'' of emissions, with no comparison to allowable
emissions. The commenter stated that if sources are being over-
controlled as EPA suggests, then EPA's analysis of risk underestimates
the risk remaining after implementation of the HON. The commenter added
that the assessment required in CAA section 112(f)(2)(A) is of the
``standards'' adopted under CAA section 112(d). If the current
``standards'' are not adequate to protect public health with an ample
margin of safety, more stringent standards are necessary. The commenter
claimed that, if sources are over-controlling, but nothing in the CAA
section 112(d) standards would prevent backsliding, the statute
requires EPA to adopt more stringent limits to maintain that over-
control. If the over-control occurs because State or local agencies
have adopted tighter limits, the commenter concluded that more
stringent limits are feasible, and EPA must either (a) adopt those
limits nationally to provide uniform protection or (b) explain why such
standards would be infeasible.
Several commenters agreed with EPA that, for this source category,
the use of 1999 actual emissions data rather than allowable emissions
do not lead to an underestimating of risk. The commenters pointed out
that the conservatism of the health benchmark values and the exposure
estimates outweigh any potential underestimation of emission levels
based on using actual emissions, and added that EPA emission data based
on actual emissions is conservatively high since the Toxics Release
Inventory shows a reduction in emissions since 1999.
Response: EPA's position on the use of both allowable and actual
emissions is fully discussed in the final Coke Oven Batteries NESHAP
(70 FR 19998-19999, April 15, 2005). There we explained that modeling
the allowable levels of emissions is inherently reasonable since they
reflect the maximum level sources could emit and still comply with
national emission standards. But we also explained that it is
reasonable to consider actual emissions, where data on them is
available, in both steps of the Benzene NESHAP analysis in order to
avoid overestimating emissions and their risks (including incidence)
and to account for how sources typically strive to perform better than
required by standards to allow for process variability and not exceed
standards due to emissions increases on individual days. Failure to
consider these data in risk assessments, we said, would unrealistically
inflate risk levels.
The preamble to the proposed HON residual risk standards included a
discussion of actual versus allowable emissions from HON emission
points (71 FR 34428). We explained that, for this source category,
using available data on actual emissions enabled us to approximate
allowable emissions, and that basing the analysis on actual
[[Page 76610]]
emissions here provided an acceptable method for determining the
remaining risks to public health and the environment after application
of the MACT standards. In the HON proposal preamble, we acknowledged
that there is some uncertainty regarding the differences between actual
and allowable emissions. For some emission points, it was not possible
to estimate allowable emissions from available information. A
requirement to determine the applicability of controls for some
emission points was intentionally not included in the HON because it
was seen as an unnecessary burden for points that would be controlled
anyway. For these emission points there is no readily available data
that can be used to determine the applicability of control
requirements. Without such data, there is no accurate way to determine
allowable emissions under the current rule. However, for equipment
leaks which represent the most significant impact on the cancer risk at
the HON facilities, the standards are work practice standards and the
actual emissions and allowable emissions are likely the same for
equipment in the leak detection and repair program required by the HON.
More frequent monitoring of equipment components (for example, monthly
instead of quarterly) could result in actual emissions being lower than
allowable emissions, but few, if any, sources monitor more frequently
than required by the HON.
We concluded that there is no reason to believe that there is
either a substantial amount of overcontrol of Group 1 sources or
voluntary control of Group 2 sources such that actual emissions are not
a reasonable approximation of allowable emissions. Rather, actual
emissions appear to reflect the results of our prior application of
MACT (allowing for process variability), and no evidence in the record
suggests that sources could make changes that significantly increase
their emissions and risks but still comply with MACT control
requirements. Consequently, basing the risk analysis on actual
emissions in this case enabled us to determine the remaining risks to
public health and the environment after application of the specific
MACT standards applicable to HON sources.
Comment: One commenter argued that EPA must address inorganic HAP.
The Risk Assessment acknowledges that inorganic HAP, such as
hydrochloric acid and chlorine, may be emitted from HON sources, but
that these compounds were not considered because data were not
available to characterize emissions. The commenter argued that EPA
cannot rely on the circular justification that the original HON
regulated only organic HAP. The commenter argued that the residual risk
provisions of CAA section 112(f) direct EPA to estimate the remaining
risk for the regulated categories, whatever chemicals that risk may
encompass. The commenter added that EPA's attempt to screen out
inorganic HAP from further risk assessment by looking at these
emissions in isolation is invalid. The commenter contended that EPA
must look at the combined target organ specific HI from all emissions
allowed under the current standards, including inorganic emissions, to
determine if the residual risk is acceptable. Moreover, the commenter
stated that EPA cannot avoid the consideration of emission controls for
inorganics based only on a screening analysis; such control decisions
for both the residual risk and the CAA section 112(d)(6) determination
must consider other factors such as costs and feasibility.
Response: We acknowledge that inorganic HAP (such as hydrochloric
acid and chlorine) are emitted from some HON sources and that these
pollutants require consideration even though they were not regulated
HAP in the existing NESHAP. We stated in the preamble to the proposed
rule that inorganic HAP were not considered in the primary assessment
because data were not available to characterize emissions. However, we
conducted an additional analysis using information in the NEI to
estimate the risk from the entire plant site at which the HON processes
are located. The NEI contains information on both organic and inorganic
HAP emitted from each facility. EPA estimated hazard indices (total,
not target organ specific) for each of the 226 HON facilities for which
NEI data were available. There were many instances where inorganic HAP
were responsible for hazard indices exceeding 1, but there were no
instances where the inorganic HAP were associated with HON processes.
Therefore, EPA concluded that not including inorganic HAP in the
primary risk assessment did not affect the results of the analysis, and
that no further assessment of inorganic HAP emissions was necessary in
order to determine whether remaining risks from HON sources after
application of MACT are at acceptable levels. Furthermore, as discussed
earlier in the preamble, it is not reasonable to impose any additional
controls to provide an ample margin of safety to protect public health.
C. Administrative Requirements
Comment: One commenter argued that EPA has not appropriately
addressed impacts on children and other sensitive receptors. The
commenter stated that even though EPA acknowledged in the risk
assessment that children face greater exposure and are more susceptible
to the adverse health effects from airborne contaminants, these factors
were not addressed. The commenter stated that EPA determined that
``[t]he proposed rule is not subject to the Executive Order (13045:
Protection of Children From Environmental Health Risks and Safety
Risks) * * * because the Agency does not have reason to believe the
environmental health or safety risks addressed by this action present a
disproportionate risk to children.'' This commenter contended that this
conclusion is based on our assessment of the information on the effects
on human health and exposures associated with SOCMI operations. The
commenter could not find such an assessment referenced in the Risk
Assessment. The commenter also stated that EPA ignored the effects on
other sensitive receptors, e.g., active adults.
Response: First, since this rulemaking is not economically
significant under Executive Order 12866, Executive Order 13045 does not
apply to this matter.
EPA acknowledges that population subgroups, including children, may
have the potential for risk greater than the general population due to
greater relative exposure and/or greater susceptibility to the
toxicant. With respect to exposure, the risk assessment implicitly
accounts for this greater potential for exposure by assuming lifetime
(rather than simply childhood) exposure, which would tend to yield
higher estimates of risks. The exposure assessment described the
maximum modeled lifetime exposure of residents near HON facilities. The
exposed population was conservatively presumed to be exposed to
airborne concentrations at their residence continuously, 24 hours per
day for a full lifetime, including childhood.
With regard to children's potentially greater susceptibility to
non-cancer toxicants emitted by HON facilities, the assessment relied
on Agency (or comparable) hazard identification and dose-response
values which have been developed to be protective for all subgroups of
the general population, including children. For example, a review \1\
of the chronic reference value
[[Page 76611]]
process concluded that the Agency's reference concentration (RfC)
derivation processes adequately considered potential susceptibility of
different subgroups with specific consideration of children, such that
the resultant RfC values pertain to the full human population
``including sensitive subgroups,'' a phrase which is inclusive of
childhood.
---------------------------------------------------------------------------
\1\ A Review of the Reference Dose and Reference Concentration
Process. U.S. Environmental Protection Agency. Risk Assessment
Forum. EPA/630/P-02/002F. December 2002.
---------------------------------------------------------------------------
On the issue of cancer dose-response values, our revised cancer
guidelines and new supplemental guidance recommend applying default
adjustment factors to account for exposures occurring during early-life
exposure to those chemicals thought to cause cancer via a mutagenic
mode of action. For these chemicals, the supplemental guidance
indicates that, in lieu of chemical-specific data on which age or life-
stage specific risk estimates or potencies can be determined, default
``age dependent adjustment factors'' can be applied when assessing
cancer risk for early-life exposures to chemicals which cause cancer
through a mutagenic mode.\2\ However, at the present time, we have not
determined whether any of the HAP emitted by the HON source category
cause cancer via a mutagenic mode of action. While several of the HON
pollutants may be carcinogenic by such a mechanism, our policy is not
to apply these adjustment factors unless we have completed a peer-
reviewed assessment that explicitly makes this determination after
consideration of the full scientific literature.
---------------------------------------------------------------------------
\2\ The ``Supplemental Guidance for Assessing Susceptibility
from Early-Life Exposure to Carcinogens'' recommends applying
default adjustment factors to early life stage exposures to
carcinogens acting through a mutagenic mode of action. The
Supplemental Guidance recommends an integrative approach that can be
used to assess total lifetime risk resulting from lifetime or less-
than-lifetime exposure during a specific portion of a lifetime. The
following adjustments represent the approach suggested in the
Supplemental Guidance: (1) For exposures before 2 years of age
(i.e., spanning a 2-year time interval from the first day of birth
up until a child's second birthday), a 10-fold adjustment; (2) for
exposures between 2 and less than 16 years of age (i.e., spanning a
14-year time interval from a child's second birthday up until their
sixteenth birthday), a 3-fold adjustment; and (3) for exposures
after turning 16 years of age, no adjustment. Assuming a constant
lifetime exposure, incorporation of these adjustment factors would
increase the estimate of lifetime cancer risk by roughly 60 percent
(factor of 1.6). If exposures were from 3 years to 73 years, the
adjustment factor would be less than 1.6. If exposures were from 16
years to 86 years, no adjustment would be necessary.
---------------------------------------------------------------------------
Although we are not yet certain whether or not a childhood potency
adjustment is needed, the estimated risks must also be considered in
the context of the full set of assumptions used for this risk
assessment. For example, we used a health-protective assumption of a
70-year exposure duration in our risk estimates; however, using the
national average residency time of 12 years would reduce the estimate
of risk by roughly a factor of 6. Our unit risk estimates for HAP are
considered a plausible upper-bound estimate; actual potency is likely
to be lower and some of which could be as low as zero. After
considering these and other factors, we continue to consider the risks
from emissions after application of the current HON rule to be
acceptable (within the meaning of the Benzene NESHAP decision framework
discussed at 69 FR 48339-48340, 48347-48348, August 9, 2004). As
mentioned in the recently published cancer guidelines, we will continue
to develop and present, to the extent practicable, an appropriate
central estimate and appropriate lower and upper-bound estimates of
cancer potency. Development of new methods or estimates is a process
that will require independent peer review.
Comment: One commenter argued that EPA failed to adequately address
environmental effects or to comply with the requirements of the
Endangered Species Act (ESA). The commenter objected to EPA's
assumption in the ecological assessment that the aquatic and
terrestrial communities surrounding HON sources were healthy and
unaffected by other stressors. Additionally, the commenter claimed that
EPA is on record acknowledging its obligation to comply with the ESA
during the residual risk phase of the air toxics program, and yet EPA
failed to do so.
Response: The commenter is correct that EPA has publicly agreed
that the consultation requirements of the ESA potentially apply to CAA
section 112(f) residual risk rulemakings. See Sierra Club v. EPA. 353
F.3d 976 (District of Columbia Circuit, 2004). This is because CAA
section 112(f)(2)(A) provides us with authority to tighten NESHAP,
after consideration of costs and other relevant factors, to prevent an
``adverse environmental effect.'' CAA section 112(a)(7) defines this
term to mean ``any significant and widespread adverse effect, which may
reasonably be anticipated, to wildlife, aquatic life, or other natural
resources, including adverse impacts on populations of endangered or
threatened species or significant degradation of environmental quality
over broad areas'' (emphasis added). Therefore, CAA section 112(f)
clearly provides EPA discretion to promulgate a residual risk rule in a
manner that inures to the benefit of listed species (see 50 CFR
402.03), at least in cases where adverse environmental effects are of a
significant magnitude.
However, under section 7(a)(2) of the ESA and the implementing
regulations promulgated by the Fish and Wildlife Service and the
National Marine Fisheries Service (collectively, the Services), an
action agency such as EPA has a duty to initiate consultation with the
services only where it determines that its action may have an impact
(either beneficial or adverse) on listed threatened or endangered
species or on their designated critical habitat. Where the action
agency determines that its action will have no such effect, the
consultation duty is not triggered. For the HON residual risk
rulemaking, based on the ecological risk analysis we discuss below, EPA
has determined that its action has no effect, either adverse or
beneficial, on listed species or their critical habitat.
We conducted a screening-level ecological risk analysis to assess
the affects of persistent and bioaccumulative toxic HAP emissions on
aquatic and terrestrial receptors. Only two HAP, hexachlorobenzene and
anthracene, were estimated to pose any potential for exposures via
routes beyond direct inhalation. All ecological hazard quotient (HQ)
values are well below levels of concern, with the highest HQ being 0.05
from benthic/sediment exposure by aquatic life to anthracene. The
highest hexachlorobenzene HQ is 0.02 from surface water exposure by
aquatic life. HQ values of equal to or less than 1.0 are indicative of
no effect. EPA concluded that these levels are not high enough to
constitute ``significant and widespread'' adverse environmental effects
as defined in CAA section 112(a)(7), and that there is not an effect on
threatened or endangered species or on their critical habitat within
the meaning of the ESA, as implemented at 50 CFR 402.14(a). Therefore,
EPA concluded that a consultation with the Services regarding
endangered species was not necessary. The statement regarding
communities being unaffected by other toxic chemicals or environmental
stressors was meant to convey that the assessment considered only the
contribution of HON emissions to media concentrations.
D. Impacts Estimation
Comment: One commenter contended that EPA overestimated the costs
for controlling process vents, equipment leaks, and storage vessels.
The commenter also contended that EPA
[[Page 76612]]
should have selected more stringent control options for these sources,
such as lower leak definitions for equipment leaks. Other commenters
expressed their view that EPA underestimated costs of controlling each
of the sources by using outdated costs and inappropriate assumptions.
Response: Cost algorithms and information used for the cost impacts
analysis were based on previous EPA studies and rulemaking actions and
are well documented and accepted. Costs from previous years were scaled
to 2001 dollars using engineering cost indices to account for
inflation. We consider the cost information that we used to estimate
impacts to be appropriate for this analysis and are not underestimated.
We would also like to clarify that we analyzed control options with
more stringent requirements for each source (e.g., requiring lower
equipment leak percent leakers and leak definitions), but determined
the emission reductions and risk reductions did not warrant the costs.
However, in response to the comments, we re-evaluated Option 2.
Before rejecting the option overall, we decided to modify Option 2 to
eliminate the high cost sources. We also re-evaluated the assumptions
used in the cost analysis to reflect a range of likely costs rather
than the most costly results.
At proposal, we estimated that sources having any amount of Table
38 HAP would be required to meet Option 2. We re-analyzed the costs of
controlling process vents and equipment leaks assuming a trigger level
of 5 percent Table 38 HAP. Additionally, we analyzed the impacts of
reducing the TRE from a value of 4 from proposal to a value of 2. At
proposal we calculated repair costs for leaking valves on a monthly
basis. For the re-analysis, we assumed there would be no additional
costs of repairing leaking valves because the frequency of repair would
not change from the current HON when sources successfully repair valves
on their existing schedule. At proposal, we calculated the annual cost
of valve monitoring assuming all sources would have to monitor monthly.
This assumption would provide the highest cost estimates. For the re-
analysis, we calculated the annual cost of valve monitoring assuming
that half of the sources would be able to conduct quarterly monitoring
and half would still conduct monthly monitoring.
The resulting total annual cost for a re-evaluated Option 2 was
estimated to be $6 million, less than half the $13 million annual cost
of Option 2, as proposed. After considering these lower annual costs,
EPA decided that the cost of further control still was not justified
considering the small reduction in health risk resulting from HAP
emission reductions achieved by Option 2.
E. Clarification Changes
Comment: Several commenters argued that many of EPA's proposed
clarifications in the solicitation of public comments are significant,
will result in additional costs and burdens with no identified
environmental benefit, and are inconsistent, in some cases, with
current rule language and 12 years of HON implementation. These
commenters maintained these changes must be adopted through a formal
rulemaking process.
Response: We have decided not to adopt some of the proposed
clarifying changes at this time. If we further consider them, we will
provide another opportunity to collect public comments on the specific
regulatory language. However, we have decided that one of the proposed
minor changes will not have any impact on costs of compliance, and are
therefore adopting it in this final rule: Re-determining the group
status of wastewater streams whenever process or operational changes
occur. We are also making two minor changes not specifically discussed
in the proposal but for which we received comments urging their
adoption: removal of MEK from tables in subparts F and G to 40 CFR part
63, and waiving recordkeeping requirements for off-site reloading or
cleaning operations that take part in the vapor balancing compliance
option for storage tanks. These changes are discussed in Section II.B
of this preamble.
We are also clarifying in this preamble that liquid streams
generated from control devices (e.g., scrubber effluent) are
wastewater. We notified the public at proposal that we intended to
incorporate this clarification in the rule. However, commenters
affirmed that the regulatory text already clarifies this and additional
rule language is unnecessary. Therefore, no rule clarification language
was added.
IV. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Office of Management and Budget (OMB) deems the final rule to be a
``significant regulatory action'' because it raises novel legal and
policy issues. Accordingly, EPA submitted the final rule to OMB for
review. Changes made in response to OMB recommendations have been
documented in the docket.
B. Paperwork Reduction Act
This action does not impose any new information collection burden.
The action does not require any further control of sources and the
amendatory changes are estimated to have at most minor costs. However,
OMB has previously approved the information collection requirements
contained in the existing regulations, 40 CFR part 63, subparts F, G,
and H, under the provisions of the Paperwork Reduction Act, 44 U.S.C.
3501, et seq., and has assigned OMB control number 2060-0443, EPA ICR
number 1854.04. A copy of the OMB approved Information Collection
Request (ICR) may be obtained from Susan Auby, Collection Strategies
Division; U.S. Environmental Protection Agency (2822T); 1200
Pennsylvania Ave., NW., Washington, DC 20460, or by calling (202) 566-
1672.
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 in 40 CFR are listed in 40 CFR part 9.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act 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 the final rule on small
entities, small
[[Page 76613]]
entity is defined as: (1) A small business as defined by the Small
Business Administration; (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 that is
independently owned and operated and is not dominant in its field.
For sources subject to the final rule, the relevant NAICS and
associated employee sizes are as follows:
NAICS 32511--Petrochemical Manufacturing--1,000 employees or fewer.
NAICS 325192--Cyclic Crudes and Intermediates Manufacturing--750
employees or fewer.
NAICS 325199--All Other Organic Chemical Manufacturing--1,000 employees
or fewer.
After considering the economic impacts of the final rule on small
entities, EPA has determined that this action will not have a
significant economic impact on a substantial number of small entities.
This action finalizes our decision not to impose further controls and
not to revise the existing rule. Consequently, there are no impacts on
any small entities.
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act (UMRA) of 1995, 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 by 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 EPA
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 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 the final 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. Thus, the final rule is not subject to the
requirements of sections 202 and 205 of the UMRA. This action finalizes
our decision not to impose further controls and not to revise the
existing rule. Consequently, there are not costs associated with this
action. In addition, today's final decision does not significantly or
uniquely affect small governments because it contains no requirements
that apply to such governments or impose obligations upon them.
Therefore, today's final decision is not subject to section 203 of
UMRA.
E. Executive Order 13132: Federalism
Executive Order 13132 (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 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.''
The 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. None of the affected SOCMI
facilities are owned or operated by State governments. Thus, Executive
Order 13132 does not apply to the final rule.
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 9, 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.'' The final rule does not have
tribal implications, as specified in Executive Order 13175. No tribal
governments own SOCMI facilities subject to the HON. Thus, Executive
Order 13175 does not apply to the final rule.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
Executive Order 13045 (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, EPA 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.
The final rule is not subject to the Executive Order because it is
not economically significant as defined in Executive Order 12866, and
because the Agency does not have reason to believe the environmental
health or safety risks addressed by the final rule present a
disproportionate risk to children. This conclusion is based on our
assessment of the information on the effects on human health and
exposures associated with SOCMI operations.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
The final 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
likely to have a significant adverse effect on the supply,
distribution, or use of energy. Further, we have concluded that this
final decision is not likely to have any adverse energy impacts.
[[Page 76614]]
I. National Technology Transfer and Advancement Act
As noted in the proposed rule, section 12(d) of the National
Technology Transfer and Advancement Act (NTTAA) of 1995, Public Law
104-113; 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary
consensus standards (VCS) in its regulatory activities unless to do so
would be inconsistent with applicable law or otherwise impractical. VCS
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by VCS bodies. The NTTAA directs EPA to provide Congress,
through OMB, explanations when the Agency does not use available and
applicable VCS.
The final rule does not involve technical standards beyond those
already provided under the current rule. Therefore, EPA did not
consider the use of any VCS.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order 12898, Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations, requires
Federal agencies to consider the impact of programs, policies, and
activities on minority populations and low-income populations.
According to EPA guidance, agencies are to assess whether minority or
low-income populations face risks or a rate of exposure to hazards that
are significant and that ``appreciably exceed or is likely to
appreciably exceed the risk or rate to the general population or to the
appropriate comparison group'' (EPA, 1998).
The Agency has recently reaffirmed its commitment to ensuring
environmental justice for all people, regardless of race, color,
national origin, or income level. To ensure environmental justice, we
assert that we shall integrate environmental justice considerations
into all of our programs and policies, and, to this end, have
identified eight national environmental justice priorities. One of the
priorities is to reduce exposure to air toxics. At proposal, EPA
requested comment on the implications of environmental justice concerns
relative to the two options proposed since some HON facilities are
located near minority and low-income populations. We received one
comment regarding environmental justice concerns that is addressed in
the response to comments document.
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 the
final rule and other required information to the United States Senate,
the United States House of Representatives, and the Comptroller General
of the United States prior to publication of the final rule in the
Federal Register. A major rule cannot take effect until 60 days after
it is published in the Federal Register. The final rule is not a
``major rule'' as defined by 5 U.S.C. 804(2). The final rule is
effective December 21, 2006.
List of Subjects in 40 CFR Part 63
Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Reporting and
recordkeeping requirements.
Dated: December 15, 2006.
Stephen L. Johnson,
Administrator.
0
For the reasons stated in the preamble, title 40, chapter I of the Code
of Federal Regulations is amended as follows:
PART 63--[Amended]
0
1. The authority citation for part 63 continues to read as follows:
Authority: 42 U.S.C. 7401, et seq.
Subpart F--[Amended]
Table 2--[Amended]
0
2. Table 2 to subpart F of part 63 is amended by removing the entry for
``Methyl ethyl ketone (2-Butanone).''
Table 4--[Amended]
0
3. Table 4 to subpart F of part 63 is amended by removing the entry for
``Methyl ethyl ketone (2-Butanone).''
Subpart G--[Amended]
0
4. Section 63.119 is amended by revising paragraph (g)(7)(ii) and
adding paragraph (g)(7)(iv) to read as follows:
Sec. 63.119 Storage vessel provisions--reference control technology.
* * * * *
(g) * * *
(7) * * *
(ii) If complying with paragraph (g)(6)(i) of this section, comply
with the requirements for closed vent system and control device
specified in Sec. Sec. 63.119 through 63.123. The notification and
reporting requirements in Sec. 63.122 do not apply to the owner or
operator of the offsite cleaning or reloading facility.
* * * * *
(iv) After the compliance dates specified in Sec. 63.100(k) at an
offsite reloading or cleaning facility subject to paragraph (g) of this
section, compliance with the monitoring, recordkeeping, and reporting
provisions of any other subpart of this part 63 constitutes compliance
with the monitoring, recordkeeping, and reporting provisions of
paragraph (g)(7)(ii) or paragraph (g)(7)(iii) of this section. You must
identify in your Notification of Compliance Status report required by
Sec. 63.152(b), the subpart to the part 63 with which the owner or
operator of the reloading or cleaning facility complies.
0
5. Section 63.132 is amended by adding paragraphs (c)(3) and (d)(3) to
read as follows:
Sec. 63.132 Process wastewater provisions--general.
* * * * *
(c) * * *
(3) The owner or operator of a Group 2 wastewater shall re-
determine group status for each Group 2 stream, as necessary, to
determine whether the stream is Group 1 or Group 2 whenever process
changes are made that could reasonably be expected to change the stream
to a Group 1 stream. Examples of process changes include, but are not
limited to, changes in production capacity, production rate, feedstock
type, or whenever there is a replacement, removal, or addition of
recovery or control equipment. For purposes of this paragraph (c)(3),
process changes do not include: Process upsets; unintentional,
temporary process changes; and changes that are within the range on
which the original determination was based.
(d) * * *
(3) The owner or operator of a Group 2 wastewater shall re-
determine group status for each Group 2 stream, as necessary, to
determine whether the stream is Group 1 or Group 2 whenever process
changes are made that could reasonably be expected to change the stream
to a Group 1 stream. Examples of process changes include, but are not
limited to, changes in production capacity, production rate, feedstock
type, or whenever there is a replacement, removal, or addition of
recovery or control equipment. For purposes of this paragraph (d)(3),
process changes do not include: Process upsets; unintentional,
temporary
[[Page 76615]]
process changes; and changes that are within the range on which the
original determination was based.
* * * * *
Table 9--[Amended]
0
6. Table 9 to subpart G of part 63 is amended by removing the entry for
``Methyl ethyl ketone (2-Butanone).''
Table 34--[Amended]
0
7. Table 34 to subpart G of part 63 is amended by removing the entry
for ``Methyl ethyl ketone (2-Butanone).''
Table 36--[Amended]
0
8. Table 36 to subpart G of part 63 is amended by removing the entry
for ``Methyl ethyl ketone (2-Butanone).''
[FR Doc. E6-21869 Filed 12-20-06; 8:45 am]
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