[Federal Register Volume 71, Number 67 (Friday, April 7, 2006)]
[Unknown Section]
[Pages 17720-17729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-3313]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2003-0161, FRL-8054-2]
RIN 2060-AK23


National Emission Standards for Magnetic Tape Manufacturing 
Operations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final action.

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[[Page 17721]]

SUMMARY: On December 15, 1994, we promulgated national emission 
standards for hazardous air pollutants for Magnetic Tape Manufacturing 
Operations. The standards limit and control emissions of hazardous air 
pollutants that are known or suspected to cause cancer or have other 
serious health or environmental effect.
    Section 112(f)(2) of the Clean Air Act directs EPA to assess the 
risk remaining (residual risk) after the application of national 
emission standards for hazardous air pollutants controls and to 
promulgate more stringent standards, if necessary, to protect public 
health with an ample margin of safety and to prevent adverse 
environmental effects. Also, section 112(d)(6) of the Clean Air Act 
requires EPA to review and revise the national emission standard for 
hazardous air pollutants, as necessary, taking into account 
developments in practices, processes, and control technologies. On 
October 24, 2005, based on the findings from our residual risk and 
technology review, we proposed no further action to revise the national 
emission standards for hazardous air pollutants and requested public 
comment. Today's final action responds to public comments received on 
the proposed action and announces EPA's final decision not to revise 
the standards.

DATES: This final action is effective on April 7, 2006.

ADDRESSES: The EPA has established a docket for this action under 
Docket ID No. EPA-HQ-OAR-2003-0161. All documents in the docket are 
listed on the http://www.regulations.gov Web site. Although listed in 
the index, some information is not publicly available, i.e., 
confidential business information (CBI) or other information whose 
disclosure is restricted by statute. Certain other material, such as 
copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available either electronically through http://www.regulations.gov or in hard copy at the HQ EPA Docket Center, Docket 
ID No. EPA-HQ-OAR-2003-0161, EPA West Building, Room B102, 1301 
Constitution Avenue, 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 HQ EPA Docket Center 
is (202) 566-1742. A reasonable fee may be charged for copying docket 
materials.

FOR FURTHER INFORMATION CONTACT: For questions about the final action, 
contact Mr. H. Lynn Dail, U.S. EPA, Office of Air Quality Planning and 
Standards, Sector Policies and Programs Division, Natural Resources and 
Commerce Group (C539-03), Research Triangle Park, North Carolina 27711; 
telephone number: (919) 541-2363; fax number: (919) 541-5689; e-mail 
address: [email protected]. For questions on the residual risk 
analysis, contact Ms. Maria Pimentel, U.S. EPA, Office of Air Quality 
Planning and Standards, Health and Environmental Impacts Division, 
Sector Based Assessment Group (C404-01), Research Triangle Park, North 
Carolina 27711; telephone number: (919) 541-5280; fax number: (919) 
541-0840; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:
    Regulated Entities. The regulated categories and entities affected 
by the national emission standards for hazardous air pollutants 
(NESHAP) include:

----------------------------------------------------------------------------------------------------------------
                                              NAICS \a\
                  Category                       code                 Examples of regulated entities
----------------------------------------------------------------------------------------------------------------
Industry...................................       334613  Operations at major sources that are engaged in the
                                                  322222   surface coating of magnetic tape.
                                                  325992
Federal government.........................  ...........  Not affected.
State, local, tribal government............  ...........  Not affected.
----------------------------------------------------------------------------------------------------------------
\a\ 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 affected by the 
Magnetic Tape NESHAP. To determine whether your facility would be 
affected by the Magnetic Tape NESHAP, you should examine the 
applicability criteria in 40 CFR part 63.701(a) of subpart EE (NESHAP 
for Magnetic Tape Manufacturing Operations). If you have any questions 
regarding the applicability of the Magnetic Tape NESHAP to a particular 
entity, contact Mr. Leonard Lazarus, U.S. EPA, Office of Enforcement 
and Compliance Assurance, Office of Compliance, Air Compliance Branch 
(2223A), Ariel Rios Building, 1200 Pennsylvania Avenue, NW., 
Washington, DC 20460; telephone number: (202) 564-6369; fax number: 
(202) 564-0050; e-mail address: [email protected].
    World Wide Web (WWW). In addition to being available in the docket, 
an electronic copy of today's final action will also be available on 
the World Wide Web through the Technology Transfer Network (TTN). 
Following signature, a copy of the final action will be posted on the 
TTN's policy and guidance page for newly proposed or promulgated rules 
at the following address: http://www.epa.gov/ttn/oarpg. The TTN 
provides information and technology exchange in various areas of air 
pollution control.
    Judicial Review. Under section 307(b)(1) of the CAA, judicial 
review of this final decision is available only by filing a petition 
for review in the United States Court of Appeals for the District of 
Columbia Circuit by June 6, 2006. Under section 307(d)(7)(B) of the 
CAA, only an objection to a rule or procedure raised with reasonable 
specificity during the period for public comment can be raised during 
judicial review. Moreover, under section 307(b)(2) of the CAA, the 
requirements established by the final decision may not be challenged 
separately in civil or criminal proceedings brought to enforce these 
requirements.
    Section 307(d)(7)(B) of the CAA further provides that ``only an 
objection to a rule or procedure which was raised with reasonable 
specificity during the period for public comment (including any public 
hearing) may be raised during judicial review.'' This section also 
provides a mechanism for us to convene a proceeding for 
reconsideration, ``if 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

[[Page 17722]]

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 
20004.
    Outline. The information presented in this preamble is organized as 
follows:

I. Background
    A. What Is the Statutory Authority for This Action?
    B. What Did the Magnetic Tape NESHAP Accomplish?
    C. What Were the Conclusions of the Residual Risk Assessment?
    D. What Were the Conclusions of the Technology Review?
    E. What Was the Proposed Action?
II. Today's Action
    A. What Is Today's Final Action?
    B. What Comments Were Received on the Proposed Action?
III. 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 and Safety Risks
    H. Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Congressional Review Act

I. Background

A. What Is the Statutory Authority for This Action?

    Section 112 of the Clean Air Act (CAA) establishes a two-stage 
regulatory process to address emissions of hazardous air pollutants 
(HAP) from stationary sources. In the first stage, after EPA has 
identified categories of sources emitting one or more of the HAP listed 
in the CAA, section 112(d) calls for us to promulgate national 
technology-based emission standards for sources within those categories 
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 (known as ``major sources''), as well as for certain 
``area sources'' emitting less than those amounts. These technology-
based standards must reflect the maximum reductions of HAP achievable 
(after considering cost, energy requirements, and non-air health and 
environmental impacts) and are commonly referred to as maximum 
achievable control technology (MACT) standards. For area sources, CAA 
section 112(d)(5) provides that, in lieu of MACT, the Administrator may 
elect to promulgate standards or requirements which provide for the use 
of generally available control technologies or management practices, 
and such standards are commonly referred to as generally available 
control technology (GACT) standards.
    The 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.
    The second stage in standard-setting is described in section 112(f) 
of the CAA. This provision requires that EPA prepare a Report to 
Congress describing, among other things, methods of estimating risks 
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 risks to persons in proximity to emitting sources, 
and recommendations as to legislation regarding such remaining risk. 
The 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, triggering the second 
stage of the standard-setting process, the residual risk stage. Section 
112(f)(2) requires us to determine for each section 112(d) source 
category, except area source categories for which we issued a generally 
available control technology standard, whether the NESHAP protects 
public health with an ample margin of safety. If the NESHAP for HAP 
``classified as a known, probable, or possible human carcinogen do not 
reduce lifetime excess cancer risks to the individual most exposed to 
emissions from a source in the category or subcategory to less than one 
in one million,'' we must decide whether additional reductions are 
necessary to provide an ample margin of safety. As a part of this 
decision, we may consider costs, technological feasibility, 
uncertainties, or other relevant factors. We must determine whether 
more stringent standards are necessary to prevent an adverse 
environmental effect (defined in section 112(a)(7) as ``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''), 
but in making this decision we must consider cost, energy, safety, and 
other relevant factors.

B. What Did the Magnetic Tape NESHAP Accomplish?

    On December 15, 1994, we promulgated the NESHAP for Magnetic Tape 
Manufacturing Operations (59 FR 64580) and required existing sources to 
comply with the NESHAP by December 15, 1996.
    The Magnetic Tape NESHAP covers HAP emissions from surface coatings 
used in the manufacture of magnetic and optical recording media used in 
audio, video, computer and magnetic stripe tape and disks. The emission 
units regulated by the Magnetic Tape NESHAP are storage tanks, mix 
preparation equipment, coating operations, waste handling devices, 
condenser vents in solvent recovery, particulate transfer operations, 
wash sinks for cleaning removable parts, equipment for flushing fixed 
lines, and wastewater treatment operations. The Magnetic Tape NESHAP 
regulates only those sources located at major sources. During the 
development of the NESHAP, we identified 25 existing magnetic recording 
media and magnetic stripe facilities, of which 14 were considered major 
and, therefore, subject to the NESHAP. Currently, there are only six 
magnetic tape manufacturing facilities remaining in the United States, 
all of which are major.
    In general, the current NESHAP requires an overall HAP control 
efficiency of at least 95 percent for emissions from each solvent 
storage tank, piece of mix preparation equipment, coating operation, 
waste handling device, or condenser vent in solvent recovery. If an 
incinerator is used to control these emissions points, an outlet HAP 
concentration of no greater than 20 parts per million by volume by 
compound may be met, instead of achieving 95 percent control, as long 
as the efficiency of the capture system is 100 percent. If a coating 
with a HAP content no greater than 0.18 kilograms per liter (1.5 pounds 
per gallon) of coatings solids is used, that coating operation does not 
require further control.
    Several solvents and particulate HAP are used in the magnetic tape 
manufacturing industry. Currently, the solvents used to the greatest 
extent are methyl ethyl ketone (MEK) and the HAP toluene, and the 
particulate HAP are

[[Page 17723]]

cobalt and cobalt compounds. At the time of promulgation of the NESHAP, 
however, the solvents in use included MEK, cyclohexanone, acetone, and 
isopropyl alcohol and the HAP toluene, methyl isobutyl ketone, toluene 
diisocyanate, ethylene glycol, methanol, xylenes, ethyl benzene, and 
acetaldehyde; and the particulate HAP included chromium, cobalt, and 
their respective compounds. Several of these compounds are no longer 
used in the industry. The compound MEK and the HAP toluene are used at 
all facilities. At the time of promulgation of the magnetic tape 
NESHAP, MEK was a listed HAP, and we estimated that HAP emissions, 
including MEK and toluene, would be reduced by 2,080 megagrams per year 
(Mg/yr) (2,300 tons per year (tpy)) from a baseline of 4,060 Mg/yr 
(4,470 tpy). Methyl ethyl ketone was later delisted by EPA in 70 FR 
75047, December 19, 2005.

C. What Were the Conclusions of the Residual Risk Assessment?

    As required by section 112(f)(2) of the CAA, we prepared a risk 
assessment to determine the residual risk posed by magnetic tape 
manufacturing operations after implementation of the NESHAP. We 
compiled a list of the six magnetic tape manufacturing facilities still 
in operation in the United States based on inventory information we 
gathered from a number of manufacturing facilities and State 
environmental program offices (e.g., whether these facilities were 
still operating and manufacturing magnetic tape).
    The major compounds emitted by the magnetic tape manufacturing 
source category are MEK and the HAP toluene, which comprise 97 percent, 
by tpy, of all emissions in the source category. The six magnetic tape 
manufacturing facilities have MEK and HAP emissions ranging from 3.9 to 
214 Mg/yr (4.3 to 236 tpy). At the time of proposal, MEK was a listed 
HAP, and the nationwide annual HAP emissions, including MEK and 
toluene, were estimated to be 468 Mg/yr (516 tpy). Methyl ethyl ketone 
has since been delisted.
    Using these data, we modeled exposure concentrations surrounding 
the six facilities, calculated the risk of possible chronic cancer and 
noncancer health effects, evaluated whether acute exposures might 
exceed relevant health thresholds, and investigated human health 
multipathway and ecological risks.
    The emissions data used in the residual risk assessment represent 
actual levels of emissions for the base year. We have no reason to 
believe that there is a substantial amount of over control compared to 
what is allowed under the MACT standard. Therefore, the results of the 
risk assessment represent our approximation of the maximum risks which 
would be allowed under compliance with the NESHAP.
    Consistent with the tiered modeling approach described in the 
Residual Risk Report to Congress of March 1999 (EPA-453/R-99-001), the 
risk assessment for this source category started with a simple 
assessment, which used health-protective assumptions in lieu of site-
specific data. The results demonstrated negligible risks for potential 
chronic cancer, chronic noncancer, and acute noncancer health 
endpoints. Also, no significant human health multipathway or ecological 
risks were identified. Had the resulting risks been determined to be 
non-negligible, a more refined analysis with site-specific data would 
have been necessary.
    The assessment is described in detail in the memorandum ``Residual 
Risk Assessment for the Magnetic Tape Manufacturing Source Category,'' 
available in the docket. Since our assessment shows that sources 
subject to the Magnetic Tape Manufacturing NESHAP pose maximum lifetime 
excess cancer risks which are significantly less than 1 in 1 million, 
EPA concluded that public health is protected with an ample margin of 
safety, and since noncancer health risks and ecological risks were also 
found to be insignificant for this source category, EPA is not 
obligated to adopt standards under section 112(f) of the CAA. Because 
risks contributed by MEK are a negligible part of the overall risk, the 
delisting of MEK has essentially no effect on the risk assessment 
performed for the proposed rule.

D. What Were the Conclusions of the Technology Review?

    Section 112(d)(6) of the CAA requires EPA to review, and revise as 
necessary (taking into account developments in practices, processes, 
and control technologies), emission standards promulgated under section 
112 no less often than every 8 years. As we stated in the preamble to 
the Coke Ovens residual risk rule (70 FR 20009), and as discussed 
below, the facts underlying a section 112(f) determination should be 
key factors in making any subsequent section 112(d)(6) determinations. 
For this and several other source categories, we were under consent 
decree deadlines to complete both the section 112(d)(6) technology 
review and the section 112(f)(2) residual risk analysis by the same 
date. As a result, we conducted the two reviews concurrently and did 
not have the results of the section 112(f)(2) analysis before we began 
the section 112(d)(6) technology review.
    We reviewed available information about the industry, talked with 
industry representatives, and contacted several facilities in the 
industry to investigate available emission control technologies and the 
potential for additional emission reductions. We did not identify any 
additional control technologies beyond those that are already in 
widespread use within the source category (e.g., carbon adsorbers, 
condensers). The only developments identified involve improvements in 
the performance of existing technologies or increased frequency of 
inspections and testing, which would achieve only small incremental 
emission reductions. However, we did discover that new product 
developments (optical recording media and solid state recording media) 
may eventually supplant magnetic tape, but these media are not 
considered magnetic tape and would not be covered under the Magnetic 
Tape NESHAP. Therefore, our investigation did not identify any 
significant developments in practices, processes, or control 
technologies in the magnetic tape manufacturing industry since 
promulgation of the original standards in 1994. We undertook the 
technology assessment for this source category consistent with our 
policy in the Coke Ovens residual risk rule (70 FR 20008-20009).

E. What Was the Proposed Action?

    On October 24, 2005, based on the findings from our residual risk 
and technology review, we proposed no further action to revise the 
NESHAP (70 FR 61417) and requested public comment.

II. Today's Action

A. What Is Today's Final Action?

    Today's final action responds to public comments received on the 
proposed action and announces our final decision not to revise the 
standards.

B. What Comments Were Received on the Proposed Action?

    In the proposed action, we requested public comment on our residual 
risk review and our technology review and on issues of delisting the 
source category and conducting future technology reviews. By the end of 
the public comment period, comments from five entities had been 
received. A summary of these comments and EPA's responses are provided 
in the sections below.

[[Page 17724]]

1. Residual Risk Determination
    Comment: Three commenters supported EPA's decisions for the 
magnetic tape source category. The commenters supported EPA's 
conclusion that no changes to the existing NESHAP for magnetic tape 
manufacturing were required to satisfy the requirements of section 
112(f). The commenters noted that EPA correctly reviewed the magnetic 
tape sources, followed the tiered risk assessment approach described in 
its Residual Risk Report to Congress, and, using a conservative 
methodology, determined that no source in the category had a maximum 
individual cancer risk exceeding the 1-in-1-million level for 
triggering promulgation of a residual risk standard under section 
112(f).
    Two of the commenters stated that EPA was correct to focus its 
section 112(f) residual risk analysis on the sources in the magnetic 
tape source category subject to section 112(d) requirements, and not 
consider risk from outside that source category. According to the 
commenters, the statutory language and construction of section 112(f) 
shows that Congress was directing EPA to perform residual risk analyses 
for individual source categories.
    Response: We acknowledge the commenters' support for our health-
protective methodology and our conclusions in the proposed notice. 
However, we do not agree that our section 112(f) residual risk analyses 
must always focus only on the sources in the category subject to 
section 112(d) requirements or that Congress intended to limit all 
residual risk analyses to the individual source categories in question. 
As we stated in the preamble to the Coke Ovens residual risk rule, 
``EPA disagrees that section 112(f) precludes EPA from considering 
emissions other than those from the source category or subcategory 
entirely.'' Rather, we have concluded that, when the statutory risk 
trigger is exceeded, the two-step approach set forward in the Benzene 
NESHAP remains the approach that we should follow in determinations 
under section 112(f). At the first step, when determining ``acceptable 
risk,'' we will consider risks that result from emissions from the 
source category only. However, during the second step, we must 
determine whether additional reductions should be required to protect 
public health with ``an ample margin of safety.'' One of the factors 
that we can consider in this second step is environmental levels of HAP 
due to emissions from sources outside the source category being 
assessed. This could include ambient background concentrations of HAP, 
as well as co-location of other emission sources that augment the 
identified risks from the source category.
2. Delisting the Source Category
    At proposal, we requested comment on whether it would be 
appropriate to delist the magnetic tape source category under section 
112(c)(9) based on the possibility that HAP emissions from the source 
category would be sufficiently low even in the absence of MACT 
standards.
    Comment: One commenter opposed delisting the magnetic tape source 
category, stating that if the source category was delisted, there would 
be nothing to prevent sources from increasing their HAP emissions 
substantially or changing their processes to emit new HAP, resulting in 
HAP levels unacceptable to public health and the environment. The 
commenter indicated that such an approach ignores the possibility that 
HAP emissions were reduced to an acceptable level because of the MACT 
requirements and that emissions could increase again without the MACT 
standard in place. Furthermore, the commenter believed that Congress 
did not intend for the residual risk review to result in delisting of 
regulated source categories; if Congress had wanted to make delistings 
dependent on or linked to the outcome of the residual risk process, it 
would have specifically mandated this in the CAA, which it did not.
    Two commenters argued that delisting a source category does not 
affect the applicability of an existing NESHAP and cited the delisting 
action following the Asbestos NESHAP as support for their argument. 
They also noted that EPA said in its proposal that no further section 
112(d)(6) reviews are required unless there is a significant change to 
the source category. Consequently, the commenters saw no benefit in 
delisting the magnetic tape source category. However, they were not 
opposed to such an action.
    One commenter supported delisting the magnetic tape source category 
under the authority of section 112(c)(9) based on EPA's finding of 
negligible risks (0.01 in 1 million). The commenter stated that EPA's 
request for comment implied that it interpreted the CAA to allow 
delisting on the basis of low risk only before a MACT standard is 
issued; however, section 112(c)(9) provides EPA with the authority to 
delist a source category whenever the Administrator makes a 
determination that the risks are below the risk criteria in the CAA and 
does not limit this authority to sources not yet subject to a MACT or 
GACT standard. According to the commenter, limiting EPA's discretion to 
delist source categories prior to issuing MACT or GACT standards also 
conflicts with the required sequence of duties under section 112, which 
does not require EPA to conduct a risk analysis until a residual risk 
evaluation is required 8 years after MACT standards are issued; 
consequently, EPA is unlikely to have sufficient data on which to base 
a delisting decision until many years after MACT standards have been 
promulgated. Furthermore, the commenter stated it is possible that 
source categories found to be low-risk after MACT standards were 
imposed may have been low-risk before the standards were imposed, 
especially magnetic tape facilities, where the risk assessment showed 
risks two orders of magnitude below the statutory criteria for 
delisting under section 112(c)(9). Finally, the commenter noted that if 
EPA was concerned that the source category would exceed risk levels if 
MACT controls were not applicable, it could use section 112(c)(9) to 
keep in place those MACT requirements needed to sustain the low-risk 
determination and delisting. According to the commenter, those 
requirements could be established as part of the delisting decision and 
maintained in the title V permit, as was done in the NESHAP for Plywood 
and Composite Wood Products.
    Response: Based on our risk assessment of the magnetic tape source 
category, we have concluded that these sources are low-risk and, 
therefore, that no further standards are required to protect public 
health with an ample margin of safety or to protect the environment. 
However, we agree with the commenter who argues that this conclusion is 
based, at least in part, on the fact that the MACT requirements for 
these sources limit HAP emissions. Further, we disagree with the 
comment that delisting will not affect the viability of the existing 
NESHAP. The commenter cited the delisting action following the Asbestos 
NESHAP as support for their argument, noting that the applicability of 
that rule was not affected by delisting. However, the Asbestos NESHAP 
was established under part 61, which is not directly relevant in this 
situation since the Magnetic Tape NESHAP is a part 63 rule. If we 
delist this source category, it is our conclusion that existing 
magnetic tape sources would no longer be subject to the NESHAP and, 
thus, HAP emissions would no longer be limited by this rule. If sources 
begin emitting

[[Page 17725]]

HAP at levels exceeding those allowed under the NESHAP, risks could 
increase, and the basis for our finding that the source category is 
low-risk could be compromised. We have already documented that 
emissions from magnetic tape manufacturing operations were 
substantially higher at promulgation, compared to more recent emissions 
estimates (after the standards were implemented). As noted in the 
October 24, 2005 proposal (70 FR 61419) and previously in this action, 
HAP emissions at promulgation were estimated to be 4,060 Mg/yr (4,470 
tpy), while HAP emissions in 2000 were estimated to be 468 Mg/yr (516 
tpy)--a difference of almost 90 percent, some of which is due to 
compliance with the MACT standard and some of which is due to 19 plant 
closures since 1994. These HAP emissions estimates include MEK, which 
has since been delisted as a HAP. More recent information suggests that 
the delisting of MEK may result in one plant reducing its emissions to 
below the major source levels. If the potential-to-emit limit for this 
facility is below the major source threshold due to the delisting of 
MEK, it would become an area source and as such would no longer be 
subject to the magnetic tape manufacturing NESHAP. Nonetheless, since 
compliance with the MACT standard is part of the basis for our low-risk 
determination, we believe that our policy objectives are best served if 
we do not delist the magnetic tape source category.
    Contrary to one commenter's contention, we did not intend to imply 
through our request for comments that we interpret section 112(c)(9) of 
the CAA to apply only before a MACT standard has been promulgated. We 
were simply seeking comment on the use of section 112(c)(9) after the 
MACT standard. However, for the reasons presented above, we have 
decided not to use section 112(c)(9) to delist the magnetic tape source 
category.
    The Agency would like to remove the burden of the repetitive review 
of Section 112 standards for low risk source categories. At the same 
time, we think it is appropriate to maintain the MACT controls, in this 
case. We plan to further investigate approaches for removing low-risk 
source categories from the Section 112 universe while maintaining MACT-
level controls. An example of a similar approach is found in the 
Plywood and Composite Wood Products MACT where we allow a subcategory 
of facilities to reduce emissions to acceptable risk levels through 
Title 5 permits and remove them from the MACT universe.
3. Future Technology Reviews
    At proposal, we requested comment on ``the notion that, barring any 
unforeseeable circumstances which might substantially change this 
source category or its emissions, we would have no obligations to 
conduct future technology reviews under CAA section 112(d)(6).'' We 
suggested this approach because of the low-risk finding for this source 
category under section 112(f).
    Comment: One commenter disagreed that low risk from a source 
category at this time should absolve EPA of its obligation to conduct 
future technology reviews. The commenter stated that, without periodic 
reviews of source categories and technology in the future reviews, EPA 
would not be aware of any technologies that have been developed or any 
``unforeseeable circumstances'' related to the source category to which 
EPA refers in the notice. Furthermore, the commenter believed that 
Congress did not intend for the residual risk review to result in the 
removal of EPA's obligation to conduct future technology reviews under 
section 112(d)(6); if Congress had wanted to make technology reviews 
dependent on or linked to the outcome of the residual risk process, it 
would have specifically mandated this in the CAA, which it did not.
    Three commenters stated that EPA has no obligation to conduct a 
technology review in the case of Magnetic Tape. According to the 
commenters, because the residual risk provisions of the CAA were not 
triggered by the magnetic tape source category's remaining low risk, 
even an initial technology review was unnecessary. The commenters noted 
that EPA only used the results of the section 112(f)(2) residual risk 
analysis to conclude that future section 112(d)(6) technology reviews 
would not be required. The commenters stated that EPA's use of a formal 
technology review as the basis for its conclusion under section 
112(d)(6) that the NESHAP did not need to be revised was inconsistent 
with EPA's prior stated position in the Coke Ovens residual risk rule 
(70 FR 20009) on determining the need for a technology review under 
section 112(d)(6). One commenter stated that if the Coke Ovens criteria 
for when a technology review is not ``necessary'' under the CAA are 
sound for subsequent technology reviews, then they are also sound for 
initial reviews, as in the case of Magnetic Tape. Another commenter 
stated that, where the ample margin of safety set in the residual risk 
rule is largely based on cost or technical feasibility, then further 
future review under section 112(d)(6) may remain viable, and additional 
controls may not be precluded if feasible, cost-effective control 
measures are identified in the future.
    Response: We stated in the preamble to the Coke Ovens residual risk 
rule that if the ample margin of safety analysis for the section 112(f) 
standard is not based at all on the availability or cost of particular 
control technologies, then advances in air pollution control technology 
should not justify revising the MACT standard pursuant to section 
112(d)(6) because the section 112(f) standard would continue to assure 
an adequate level of safety. We agree that a technology review is 
required every 8 years. However, if the ample margin of safety analysis 
for a section 112(f) standard shows that remaining risk for non-
threshold pollutants falls below 1 in 1 million and for threshold 
pollutants falls below a similar threshold of safety, then further 
revision should not be needed because an ample margin of safety has 
already been assured. In these situations, it is difficult to conceive 
of a case where the development of new technology, or of inexpensive 
control strategies, would cause us to require additional requirements 
for a source category. If the availability and/or costs of technology 
are part of the rationale for the ample margin of safety determination, 
it is reasonable to conclude that changes in those costs or in the 
availability of technology could alter our conclusions regarding the 
ample margin of safety. For this reason, we agree with the comment that 
subsequent technology reviews would be appropriate and revisions may 
also be appropriate if the ample margin of safety established by the 
residual risk process considers cost or technical feasibility.
    We disagree with the comment that we should not have conducted an 
initial technology review under section 112(d)(6) for the magnetic tape 
source category. As we noted in the preamble to the Coke Ovens residual 
risk rule, we believe that the findings that underlie a section 112(f) 
determination should be key factors in making any subsequent section 
112(d)(6) determinations. As indicated by the inclusion of the word 
``subsequent'' in this rationale, we believe that we are obligated to 
perform the initial section 112(d)(6) analysis. The timing requirements 
for the initial section 112(d)(6) analysis coincide with those for the 
residual risk analysis. Thus, it is appropriate for us to conduct both 
analyses at the same time and for the results of the risk analysis to 
impact future section 112(d)(6) technology reviews, even though these 
results do

[[Page 17726]]

not negate either the need to perform the initial review or the need to 
perform subsequent reviews under section 112(d)(6).
4. General Approach to Technology Reviews
    Comment: Three commenters stated that action is not necessarily 
required under section 112(d)(6) even if a residual risk rule does not 
reduce cancer risks for all persons to a level below 1 in 1 million. 
Two of the commenters noted that EPA had already rejected such a 
``bright line'' approach under section 112(f) in the Coke Ovens 
residual risk rule; instead, it serves as a trigger point to evaluate 
whether additional reductions are necessary to provide an ample margin 
of safety. The third commenter cited the legislative history of the 
1990 amendments to the CAA as support that Congress had rejected 
provisions requiring sources to meet a 1-in-1-million standard. 
According to this commenter, EPA's proposed interpretation of section 
112(d)(6) of requiring successive reviews unless sources achieve this 
risk level implies that sources must meet a 1-in-1-million standard to 
avoid future regulation, and if Congress had intended this 
``technology-based'' downward revision of the standard, there would 
have been no need for section 112(f).
    Noting that EPA's risk estimates are upper bound estimates that 
likely overstate risks, the first two commenters stated that a ``bright 
line'' approach should not be employed under section 112(d)(6) any more 
than it should be employed under section 112(f); instead, they stated 
that EPA should make determinations of whether a technology review is 
necessary on a case-by-case basis for each category.
    The third commenter stated that section 112(d)(6) should be more 
appropriately viewed as a regulatory backstop authority, similar to the 
case-by-case ``MACT hammer'' provisions of section 112(j), to ensure 
that available advances in technology will be applied in the event EPA 
fails to issue residual risk standards under section 112(f). The 
commenter stated that once EPA has established a residual risk standard 
under section 112(f) that is ``acceptable'' or ``safe'' and protective 
with an ``ample margin of safety,'' then it must find that a separate 
revision of the MACT standard under section 112(d)(6) is not necessary.
    Response: We agree with the commenters who indicated that it would 
be sufficient not to revise MACT standards citing section 112(d)(6) 
even if cancer risks are greater than or equal to 1 in 1 million. For 
example, it may be the case that a technology review is performed, but 
no change in the standard results from that review. In the preamble to 
the residual risk rule for Coke Ovens, we have applied a similar logic 
to the need for subsequent technology revisions under section 
112(d)(6). As we stated in the Coke Ovens rule, if the ample margin of 
safety analysis for a section 112(f) standard shows that the remaining 
risk for non-threshold pollutants falls below 1 in 1 million and for 
threshold pollutants falls below a similar threshold of safety, then 
further revision would not be needed because an ample margin of safety 
has already been assured.
5. Context of the Residual Risk Program
    Comment: One commenter strongly recommended that EPA carefully lay 
out the context and framework of the residual risk program in the 
determination for each source category. The commenter stated that this 
was especially important because of the unique nature of the program 
compared to other EPA programs with which the public is familiar.
    The commenter specifically recommended that EPA mention the two-
stage regulatory process (MACT and residual risk) used to control HAP 
emissions from major stationary sources and to determine whether the 
MACT technology controls provide an ample margin of safety. The 
commenter noted that the residual risk program is different from other 
EPA programs, in that additional controls will be necessary for only 
some of the listed categories of sources, because in some cases, the 
cancer risk will be less than the 1-in-1-million trigger, or, if it is 
greater, EPA may determine that the current emission level provides the 
public with an ample margin of safety.
    The commenter also recommended that EPA put into the proper context 
the relatively small contribution of major stationary sources to the 
risks from air toxics--about 11 percent in 1999 and expected to be even 
smaller as sources come into compliance with the latest MACT rules.
    Finally, the commenter recommended that EPA present the risks from 
air toxics in context with the risks from ambient (criteria) air 
pollutants to make clear to the public how the air toxics risk 
estimates are much more conservative and to avoid any misperceptions by 
the public that the risk estimates for ambient air pollutants are 
comparable to the risk estimates for air toxics. Without a program of 
public education on this issue, the commenter indicated the public may 
incorrectly believe that the ample margin of safety decisions in the 
residual risk rules are less stringent than EPA knows them to be, 
resulting in public lawsuits against EPA's decisions or overregulation 
by EPA to compensate for the gap in public knowledge. The commenter 
recommended that EPA include preamble language in future EPA decisions 
describing the criteria it used to determine the ample margin of safety 
and presenting the incremental risk/incremental cost approach in the 
fuller context for the residual risk program.
    Response: We agree that it is important to provide context for any 
residual risk rule. In the preamble of the current rule, we describe 
the MACT program and its impact on the magnetic tape source category. 
We also describe our statutory authority and our obligations to assess 
risks to human health and the environment under section 112(f) of the 
CAA, as well as the requirement to further regulate categories of 
sources if any of the estimated individual cancer risks exceed the 
statutory trigger level of 1 in 1 million.
    We agree that our risk assessment for the magnetic tape source 
category appropriately contains a number of health-protective 
assumptions, resulting in a screening assessment that is designed to 
overestimate, rather than underestimate, risks. The results demonstrate 
negligible risks for potential chronic cancer, chronic noncancer, and 
acute noncancer health endpoints. Also, no significant human health 
multipathway or ecological risks were identified. Had the resulting 
risks been determined to be non-negligible, a more refined analysis 
with site-specific data would have been conducted. Such an assessment 
would be more data-intensive; however, it would also present a more 
accurate estimate of risks which could then be used as the basis for 
regulatory action. However, since the findings of the screening risk 
assessment for the magnetic tape source category were negative (i.e., 
the statutory cancer risk trigger level was not exceeded), it was not 
necessary to conduct a more refined risk assessment using more site-
specific data. Since these activities were not relevant to this action, 
a complete discussion of them in the context of a full discussion of 
the residual risk program was not deemed necessary or appropriate. The 
details of our risk assessment can be found in the docket in the memo 
titled, ``Residual Risk Assessment for the Magnetic Tape Manufacturing 
Source Category.''
6. IRIS Data for Acrylonitrile
    Comment: According to one commenter, EPA should not have relied

[[Page 17727]]

on the outdated unit cancer risk value for acrylonitrile contained in 
EPA's Integrated Risk Information System (IRIS) in conducting its 
residual risk assessment of the magnetic tape manufacturing industry. 
Although EPA concluded that there were no issues to be addressed 
regarding acrylonitrile because the facility emitting acrylonitrile 
presented a potential cancer risk of only 1 in 100 million, the 
commenter stated that it was inappropriate for EPA to use the 
acrylonitrile value in IRIS in its assessment because EPA was already 
aware the value was severely out-of-date. According to the commenter, 
the IRIS profile itself indicates that there are one or more 
significant new studies based on a screening-level review of the more 
recent toxicology literature. The commenter also noted that EPA was 
aware that numerous new studies had been conducted on assessing the 
cancer risk from acrylonitrile because its staff were briefed on an 
assessment of those new studies, received copies of the assessment 
report, and attended a peer review meeting on the report. The commenter 
also noted that a summary of the cancer assessment was published in 
October 2005.
    Response: We agree that our IRIS assessment for acrylonitrile does 
not consider studies published after 1991, and we are currently 
developing an assessment that includes newer information. Our staff 
reviewed the assessment referenced by the commenter and determined that 
it has several weaknesses. First, the assessment concludes that the 
mode of action (MOA) is nonlinear, but does not provide evidence or 
analysis sufficient to demonstrate nonlinearity or to identify a 
nonlinear MOA. The independent peer panel that reviewed this assessment 
noted that the data do not allow unequivocal determination of 
acrylonitrile's MOA(s), and could not rule out a genotoxic MOA. Given 
the negligible contribution of the acrolitrile risk estimates in this 
assessment, we determined that it was reasonable and protective to 
continue to use linear low-dose extrapolation. Second, the assessment 
provides a supplemental linear unit risk value but bases it upon animal 
data rather than human data, despite the fact that adequate human data 
were available. Using these human data would have produced a higher 
inhalation unit risk estimate (i.e., closer to the current IRIS 
assessment value). Third, the linear unit risk value came from a 
reanalysis of animal data already considered in EPA's 1991 IRIS 
assessment for inhalation carcinogenicity, and rejected because better 
human data were available even then. For these reasons we concluded 
that the commentor's study should not be used in lieu of the current 
IRIS assessment.

III. Statutory and Executive Order Reviews

A. Executive Order 12866, Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA 
must determine whether a regulatory action is ``significant'' and, 
therefore, subject to Office of Management and Budget (OMB) review and 
the requirements of the Executive Order. The Executive Order defines a 
``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.
    Pursuant to the terms of Executive Order 12866, OMB has notified 
EPA that it considers this a ``significant regulatory action'' within 
the meaning of the Executive Order. The EPA has submitted this action 
to OMB for review. Changes made in response to OMB suggestions or 
recommendations will be documented in the public record.

B. Paperwork Reduction Act

    This action does not impose any information collection burden. It 
will not change the burden estimates from those previously developed 
and approved for the existing NESHAP. However, OMB has previously 
approved the information collection requirements contained in the 
existing regulation (59 FR 64580, December 15, 1994) under the 
provisions of the Paperwork Reduction Act (44 U.S.C. 3501, et seq.) and 
has assigned OMB control number 2060-0326 (EPA ICR No. 1678.05). A copy 
of the OMB approved Information Collection Request (ICR) may be 
obtained from Susan Auby, by mail at the Office of Environmental 
Information, Collection Strategies Division, U.S. EPA (2822T), 1200 
Pennsylvania Avenue, NW., Washington, DC 20460, by e-mail 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 
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 in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) 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 impact of today's final action on 
small entities, a small entity is defined as: (1) A small business 
whose parent company has fewer than 500 to 1,000 employees, depending 
on the size definition for the affected NAICS code (as defined by Small 
Business Administration size standards); (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.

[[Page 17728]]

    After considering the economic impact of today's final action on 
small entities, EPA has concluded that this final action will not have 
a significant economic impact on a substantial number of small 
entities. The final action will not impose any requirements on small 
entities. We are taking no further action at this time to revise the 
NESHAP.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law No. 104-4, establishes requirements for Federal agencies to assess 
the effect 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 by the private sector, of $100 million or more in any 
1 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 of 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.
    The EPA has determined that the final action 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 for the 
private sector in any 1 year. The rule imposes no enforceable duty on 
State, local, or tribal governments, or the private sector. Thus, 
today's final action is not subject to the requirements of sections 202 
and 205 of the UMRA. In addition, EPA has determined that the final 
action contains no regulatory requirements that might significantly or 
uniquely affect small governments, because it contains no requirements 
that apply to such governments or impose obligations upon them. 
Therefore, the final action is not subject to the requirements of 
section 203 of the UMRA.

E. Executive Order 13132, Federalism

    Executive Order 13132, entitled ``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'' are 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.'' Today's 
final action 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 facilities are 
owned or operated by State or local governments. Thus, Executive Order 
13132 does not apply to the final action.

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 action does not 
have tribal implications as specified in Executive Order 13175. 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 today's final action.

G. Executive Order 13045, Protection of Children From Environmental 
Health 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 EPA.
    The final action is not subject to the Executive Order because it 
is not economically significant as defined in Executive Order 12866, 
and because EPA does not have reason to believe the environmental 
health or safety risks addressed by this action present a 
disproportionate risk to children.

H. Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    The final action is not subject to Executive Order 13211 (66 FR 
28355, May 22, 2001) because it is not an economically significant 
regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Under section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (NTTAA), Public Law No. 104-113, Sec.  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. The VCS are 
technical standards (e.g., materials specifications, test methods, 
sampling procedures, and business practices) that are developed or 
adopted VCS bodies. The NTTAA directs EPA to provide Congress, through 
OMB, explanations when EPA does not use available and applicable VCS.
    The final action does not involve technical standards. Therefore, 
EPA is not considering the use of any voluntary consensus standards.

J. 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

[[Page 17729]]

copy of the rule, to each House of the Congress and to the Comptroller 
General of the United States. The EPA will submit a report containing 
the final action 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 action 
in the Federal Register. The final action is not a ``major rule'' as 
defined by 5 U.S.C. 804(2). The effective date of this final action is 
April 7, 2006.

List of Subjects in 40 CFR Part 63

    Environmental protection, Administrative practice and procedures, 
Air pollution control, Hazardous substances, Intergovernmental 
relations, Reporting and recordkeeping requirements.

    Dated: March 31, 2006.
Stephen L. Johnson,
Administrator.
[FR Doc. 06-3313 Filed 4-6-06; 8:45 am]
BILLING CODE 6560-50-P