61404 Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Proposed Rules 

remainder of the rule, EPA may adopt 

as final those provisions of the rule that 

are not the subject of an adverse 

comment. 

For additional information, see the 

direct final rule which is located in the 

Rules section of this Federal Register. 

Dated: August 11, 2005. 

Ira W. Leighton, 

Acting Regional Administrator, EPA New 

England. 

[FR Doc. 05–21195 Filed 10–21–05; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 63 

[OAR–2003–0197; FRL –7987–5] 

RIN 2060–AK09 

Ethylene Oxide Emissions Standards 

for Sterilization Facilities 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed decision; request for 

public comment. 

SUMMARY: On December 6, 1994, we 

promulgated Ethylene Oxide Emission 

Standards for Sterilization Facilities (59 

FR 62585). The national emission 

standards limit and control hazardous 

air pollutants (HAP) 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 

(CAA) directs EPA to assess the risk 

remaining (residual risk) after the 

application of national emission 

standards controls and revise as 

necessary to protect public health. Also, 

CAA section 112(d)(6) requires us to 

review and to revise the national 

emission standards as necessary by 

taking into account developments in 

practices, processes, and control 

technologies. The proposal announces a 

decision and requests public comments 

on the residual risk assessment and 

technology review for the national 

emission standards. We are proposing 

no further action at this time to revise 

the national emission standards. 

DATES: Comments. Comments must be 

received on or before December 8, 2005. 

Public Hearing. If anyone contacts EPA 

requesting to speak at a public hearing 

by November 8, 2005, a public hearing 

will be held approximately 20 days 

following publication of this notice in 

the Federal Register. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. OAR–2003–

0197 (Legacy Docket A–88–03), by one 

of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Agency Web site: http:// 

www.epa.gov/edocket. EDOCKET, EPA’s 

electronic public docket and comment 

system, is EPA’s preferred method for 

receiving comments. Follow the on-line 

instructions for submitting comments. 

• E-mail: a-and-r-docket@epa.gov. 

• Fax: (202) 566–1741. 

• Mail: Air Docket, EPA, Mailcode: 

6102T, 1200 Pennsylvania Avenue, 

NW., Washington, DC 20460. Please 

include a total of two copies. 

• Hand Delivery: EPA, 1301 

Constitution Avenue, NW., Room B102, 

Washington, DC 20460. Such deliveries 

are only accepted during the Docket’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID No. OAR–2003–0197 (Legacy 

Docket A–88–03). The EPA’s policy is 

that all comments received will be 

included in the public docket without 

change and may be made available 

online at http://www.epa.gov/edocket, 

including any personal information 

provided, unless the comment includes 

information claimed to be Confidential 

Business Information (CBI) or other 

information whose disclosure is 

restricted by statute. Do not submit 

information that you consider to be CBI 

or otherwise protected through 

EDOCKET, regulations.gov, or e-mail. 

The EPA EDOCKET and the Federal 

regulations.gov Web sites are 

‘‘anonymous access’’ systems, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through 

EDOCKET or regulations.gov, your email address will be automatically 

captured and included as part of the 

comment that is placed in the public 

docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: All documents in the docket 

are listed in the EDOCKET index at 

http://www.epa.gov/edocket. Although 

listed in the index, some information is 

not publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in EDOCKET or in hard 

copy at the Air and Radiation Docket, 

EPA/DC, EPA West, Room B102, 1301 

Constitution 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 Air 

and Radiation Docket is (202) 566–1742. 

Public Hearing. If a public hearing is 

held, it will begin at 10 a.m. and will 

be held at the EPA’s campus in Research 

Triangle Park, North Carolina, or at an 

alternate facility nearby. Persons 

interested in presenting oral testimony 

or inquiring as to whether a public 

hearing is to be held should contact Mr. 

David Markwordt, Policy Planning and 

Standards Group, Emission Standards 

Division, U.S. EPA (C439–04), Research 

Triangle Park, NC 27711, telephone 

(919) 541–0837. 

FOR FURTHER INFORMATION CONTACT: For 

additional information on this proposed 

decision, review the reports listed in the 

SUPPLEMENTARY INFORMATION section. 

General and technical information. 

Mr. David Markwordt, EPA, Office of 

Air Quality Planning and Standards, 

Emission Standards Division, Policy 

Planning and Standards Group (C439–

04), Research Triangle Park, North 

Carolina 27711, telephone (919) 541–

0837, facsimile number (919) 541–0942, 

electronic mail (e-mail) address: 

markwordt.david@epa.gov. 

Residual risk assessment information. 

Mr. Mark Morris, EPA, Office of Air 

Quality Planning and Standards, 

Emission Standards Division, Risk and 

Exposure Assessment Group (C404–01), 

Research Triangle Park, North Carolina 

27711, telephone (919) 541–5416, 

facsimile number (919) 541–0840, 

electronic mail (e-mail) address: 

morris.mark@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Regulated Entities. The regulated 

categories and entities affected by the 

national emission standards include: 

Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Proposed Rules 61405 

Category NAICS* Examples of regulated 

entities 

Industry ................................................ 3841, 3842 ........................................................................................................ Medical suppliers. 

2834, 5122, 2831, 2833 ................................................................................... Pharmaceuticals. 

2099, 5149, 2034, 2035, 2046 ......................................................................... Spice manufacturers. 

7399, 7218, 8091 ............................................................................................. Contract sterilizers. 

* North American Information 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 national emission 

standards. To determine whether your 

facility would be affected by the 

national emission standards, you should 

examine the applicability criteria in 40 

CFR 63.360. If you have any questions 

regarding the applicability of the 

national emission standards to a 

particular entity, consult either the air 

permit authority for the entity or your 

EPA regional representative as listed in 

40 CFR 63.13. 

Worldwide Web (WWW). In addition 

to being available in the docket, an 

electronic copy of today’s proposed 

decision will also be available on the 

WWW through the Technology Transfer 

Network (TTN). Following signature, a 

copy of the proposed decision 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. 

Reports for Public Comment. We have 

prepared two summary memoranda 

covering the rationale for the proposed 

decision and the residual risk analyses. 

These memoranda are entitled: 

‘‘Technology Review and Residual Risk 

Development for the Ethylene Oxide 

Commercial Sterilization NESHAP,’’

and ‘‘Residual Risk Assessment for the 

Ethylene Oxide Commercial 

Sterilization Source Category.’’ Both 

reports are in the Docket No. OAR–

2003–0197 (Legacy Docket A–88–03). 

See the preceding Docket section for 

docket information and availability. 

Outline 

The information presented in this 

preamble is organized as follows: 

I. Background 

A. What is the statutory authority for these 

actions? 

B. What is our approach for developing 

residual risk standards? 

C. What are the current standards? 

D. What are the results of the residual risk 

assessment? 

E. What are our conclusions regarding the 

need for more stringent standards under 

section 112(f)(2)? 

F. How are we addressing GACT at area 

sources for purposes of section 112(f)? 

G. What are the results of the technology 

review? 

II. 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 & 

Safety Risks 

H. Executive Order 13211: Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

I. National Technology Transfer 

Advancement Act 

I. Background 

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 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 

national emission 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. 

On December 6, 1994 (59 FR 62585), 

we promulgated national emission 

standards for Ethylene Oxide 

Commercial Sterilization and 

Fumigation Operations. In that final 

rule, we set MACT for major sources 

under section 112(d)(2). As for area 

sources, we established MACT 

standards for certain emission points 

pursuant to section 112(d)(2) and GACT 

standards for other emission points 

pursuant to section 112(d)(5). 

Section 112(d)(6) provides that EPA 

review these technology-based 

standards and 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, 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 the ‘‘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 phase. 

Section 112(f)(2) requires us to 

determine for each section 112(d) source 

category whether the national emission 

standards protect public health with an 

ample margin of safety. If the national 

emission standards 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,’’ EPA must promulgate residual 

risk standards for the source category (or 

subcategory) as necessary to provide an 

ample margin of safety. EPA must also 

61406 Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Proposed Rules 

1This reading is confirmed by the Legislative 

History to CAA section 112(f); see, e.g., ‘‘A 

Legislative History of the Clean Air Act 

Amendments of 1990,’’ vol. 1, page 877 (Senate 

Debate on Conference Report). 

2Legislative History, vol. 1, p. 877, stating, 

‘‘* * * the managers intend that the Administrator 

shall interpret this requirement [to establish 

standards reflecting an ample margin of safety] in 

a manner no less protective of the most exposed 

individual than the policy set forth in the 

Administrator’s benzene regulations * * *.’’

3 ‘‘Residual Risk Report to Congress,’’ March 

1999, EPA–453/R–99–001, page ES–11. 

4 Id. 

adopt more stringent standards to 

prevent an adverse environmental effect 

(defined in section 112(a)(7) as ‘‘any 

significant and widespread adverse 

effect * * * to wildlife, aquatic life, or 

natural resources * * *.’’), but must 

consider cost, energy, safety, and other 

relevant factors in doing so. 

Section 112(f)(5) expressly provides, 

however, that EPA is not required to 

conduct any review under section 112(f) 

or promulgate any emissions limitations 

under that subsection for any area 

source listed pursuant to section 

112(c)(3) for which EPA has issued 

GACT standards. Thus, although EPA 

has discretion to conduct a residual risk 

review under section 112(f) for area 

sources for which it has established 

GACT, it is not required to do so. See 

CAA section 112(f)(5). 

B. What is our approach for developing 

residual risk standards? 

Following our initial determination 

that the individual most exposed for the 

emissions category considered exceeds a 

1-in-1 million lifetime excess cancer 

risk, our approach to developing 

residual risk standards is based on a 

two-step determination of acceptable 

risk and ample margin of safety. The 

first step, consideration of acceptable 

risk, is only a starting point for the 

analysis that determines the final 

standards. The second step determines 

the ample margin of safety which 

corresponds to the levels at which the 

standards are set. 

The terms ‘‘individual most exposed,’’

‘‘acceptable level,’’ and ‘‘ample margin 

of safety’’ are not specifically defined in 

the CAA. However, CAA section 

112(f)(2)(B) refers positively to the 

interpretation of these terms in our 1989 

rulemaking (54 FR 38044, September 14, 

1989), ‘‘National Emission Standards for 

Hazardous Air Pollutants (NESHAP): 

Benzene Emissions from Maleic 

Anhydride Plants, Ethylbenzene/ 

Styrene Plants, Benzene Storage Vessels, 

Benzene Equipment Leaks, and Coke 

By-Product Recovery Plants,’’ (Benzene 

NESHAP). We read CAA section 

112(f)(2)(B) as essentially directing us to 

use the interpretation set out in that 

notice 1 or to utilize approaches 

affording at least the same level of 

protection.2 We likewise notified 

Congress in its Residual Risk Report that 

we intended to use the Benzene 

NESHAP approach in making CAA 

section 112(f) residual risk 

determinations.3

In the Benzene NESHAP (54 FR 

38044–45, September 14, 1989), we 

stated as an overall objective: 

* * * in protecting public health with an 

ample margin of safety, we strive to provide 

maximum feasible protection against risks to 

health from hazardous air pollutants by: (1) 

protecting the greatest number of persons 

possible to an individual lifetime risk level 

no higher than approximately 1 in 1 million; 

and (2) limiting to no higher than 

approximately 1 in 10 thousand [i.e., 100 in 

a million] the estimated risk that a person 

living near a facility would have if he or she 

were exposed to the maximum pollutant 

concentrations for 70 years. 

As explained more fully in our 

Residual Risk Report to Congress, these 

goals are not ‘‘rigid line[s] for 

acceptability,’’ but rather broad 

objectives to be weighed ‘‘with a series 

of other health measures and factors.’’ 4

C. What are the current standards? 

The Ethylene Oxide Emission 

Standards for Sterilization Facilities 

were promulgated on December 6, 1994 

(59 FR 62585) and cover ethylene oxide, 

the only HAP emitted from the 

sterilization/fumigation process. The 

national emission standards regulate 

both major and area sources; the 

emission points regulated are the main 

sterilization and aeration room vents. 

The standards for major sources require 

that sources reduce main sterilization 

and aeration room vent emissions by 99 

percent. The standards for area sources 

require that sources reduce main 

sterilization vent emissions by 99 

percent. 

During the development of the 

national emission standards, we 

estimated that there were approximately 

188 facilities nationwide, of which 47 

were major sources. Usually, these 

operations are not located at facilities 

with other types of HAP-emitting 

sources. The majority of sterilization 

facilities process on a contract basis, but 

some medical supply and spice 

manufacturers sterilize their own 

products. We estimated that the national 

emission standards would reduce 

emissions of ethylene oxide by 1,000 

tons annually. 

D. What are the results of the residual 

risk assessment? 

Pursuant to CAA section 112(f)(2), we 

prepared a risk assessment to determine 

the residual risk posed by ethylene 

oxide sterilization facilities after 

implementation of the ethylene oxide 

national emission standards. The 

number of facilities in the source 

category has decreased since the 

development of the national emission 

standards for various reasons, including 

industry consolidation. We developed a 

list of 76 facilities that currently 

comprises both the major and area 

source categories, based on information 

primarily from the following three 

sources: (1) The 1999 National 

Emissions Inventory (NEI), (2) the 2000 

Toxics Release Inventory (TRI), and (3) 

the Ethylene Oxide Sterilization 

Association (EOSA). We used these data 

sources for emissions and emission 

point release parameters in dispersion 

modeling. 

As stated previously, consistent with 

section 112(f)(2), EPA must determine 

for each section 112(d) source category 

whether the MACT standards protect 

public health with an ample margin of 

safety. Because MACT and GACT are 

both required of some area sources, risk 

attributed to GACT emission points are 

included in the overall modeled risks 

for MACT. Therefore, the risks 

presented below are higher than just 

those risks attributed solely to emission 

points for which we established MACT 

in 1994. 

Using the above-noted information, 

we modeled ambient concentrations 

near these facilities and calculated the 

risk of possible chronic cancer and 

noncancer health effects and evaluated 

whether acute exposures might exceed 

relevant health thresholds. We found 

that individual lifetime cancer risks 

exceeded 1-in-1 million in areas near 44 

of the 76 modeled sources, and 

approximately 250,000 people live in 

these areas. Individual lifetime cancer 

risks exceeded 10-in-1 million in areas 

near 19 sources, and approximately 

7,300 people live in these areas. The 

highest calculated individual lifetime 

cancer risk was 90-in-1 million at one 

facility. 

An EPA assessment for ethylene oxide 

is currently under way. The EPA has not 

yet completed a full evaluation of the 

data on which it will determine an EPA 

cancer unit risk estimate for ethylene 

oxide. The EPA is also developing an 

acute reference exposure value for 

ethylene oxide. The schedule for both of 

these actions can be found at: http:// 

cfpub.epa.gov/iristrac. 

Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Proposed Rules 61407 

5Although we conducted a risk assessment which 

included emissions from those vents for which we 

set GACT in 1994, we are exercising our discretion 

under section 112(f)(5) not to undertake the section 

112(f)(2) analysis for those GACT emission points. 

See CAA sections 112(f)(2)(A), (B) and (f)(5). The 

discussion in this section of the preamble, 

therefore, is limited to those emission points for 

which we established MACT in 1994. 

Under section 112(o)(7) of the CAA, 

we are required to issue revised cancer 

guidelines prior to the promulgation of 

the first residual risk rule under section 

112(f) (an implication being that we 

should consider these revisions in the 

various residual risk rules). We have 

issued revised cancer guidelines and 

also supplemental guidance which deal 

specifically with assessing the potential 

added susceptibility from early-life 

exposure to carcinogens. The 

supplemental guidance provides an 

approach for adjusting risk estimates to 

incorporate the potential for increased 

risk due to early-life exposures to 

chemicals that are thought to be 

carcinogenic by a mutagenic mode of 

action. We are currently evaluating the 

available scientific information 

associated with ethylene oxide to see if 

‘‘age dependent adjustment factors’’

should be applied when assessing 

cancer risk for early-life exposures 

which cause cancer through a 

mutagenic mode. If the scientific 

information indicates that it is 

appropriate to apply age dependent 

adjustment factors, then we will 

reassess the risks from exposure to 

ethylene oxide prior to the 

promulgation of the final rule. 

Estimated annual cancer incidence 

rates were also calculated from 

predicted individual cancer risks for the 

people reported to reside in the U.S. 

census blocks within the modeled area 

around each facility (i.e., within 50 

kilometers). For the 44 facilities for 

which estimated maximum individual 

cancer risk is greater than 1-in-1 

million, the summed estimated annual 

cancer incidence is 0.01 cases per year. 

Across all 76 modeled facilities, the 

total estimated annual incidence is 0.04 

cases per year. We estimated that values 

presented here are incremental rates 

based on modeled concentrations and 

2000 U.S. census data, and they should 

not be interpreted as actual cancer 

incidence rates derived from 

observations of disease occurrence over 

time (such as cancer incidence rates that 

may be reported based on 

epidemiological studies). 

The highest chronic noncancer hazard 

index was 0.03. This means that the 

highest lifetime exposures to ethylene 

oxide were only 3 percent of the chronic 

noncancer reference concentration 

(RfC). Finally, we found that acute 

exposures, which were calculated by 

assuming the maximum hourly 

emissions rate and worst-case 

meteorological conditions, did not 

exceed any of the relevant health 

thresholds for acute effects for ethylene 

oxide. 

We also consider an adverse 

environmental effect as a part of a 

residual risk assessment. Regarding the 

inhalation exposure pathway for 

terrestrial mammals, we conclude that 

human toxicity values for the inhalation 

pathway are generally protective of 

terrestrial mammals. Because the 

maximum cancer and noncancer 

hazards to humans from inhalation 

exposure are relatively low, we expect 

no significant and widespread adverse 

effects to terrestrial mammals from 

inhalation exposure to ethylene oxide 

from commercial sterilization facilities. 

Some HAP which are persistent and 

bioaccumulative can also pose risks via 

pathways other than inhalation (e.g., by 

depositing to the ground and entering 

the food chain). The EPA has developed 

a list of persistent, bioaccumulative, and 

toxic (PBT) HAP based on information 

from the Pollution Prevention program, 

the Great Waters program, the TRI, and 

additional analysis conducted by the 

Office of Air Quality Planning and 

Standards. Ethylene oxide is not on the 

list of PBT. Consequently, we conclude 

the noninhalation risks to be minimal, 

and we conclude that a quantitative risk 

assessment for multipathway exposures 

is unnecessary. 

The details of this analysis can be 

found in our ‘‘Memorandum: Data and 

Assumptions Used for the Screeninglevel Residual Risk Analysis of the 

Commercial Ethylene Oxide Sterilizers 

and Fumigators Source Category’’ and 

the supporting ‘‘Memorandum: Residual 

Risk Assessment for Ethylene Oxide 

Commercial Sterilization Source 

Category.’’ See ‘‘Reports for Public 

Comment’’ in the SUPPLEMENTARY

INFORMATION section above for 

information on obtaining these reports. 

E. What are our conclusions regarding 

the need for more stringent standards 

under section 112(f)(2)? 

In the first step of the decisionmaking process under section 112(f)(2), 

the determination of acceptability, we 

note that the maximum individual 

excess lifetime cancer risk associated 

with any facility with MACT is less than 

what we would normally consider as 

the upper limit of acceptable risk (i.e., 

less than 100-in-1 million).5 Therefore, 

we are satisfied that these sources 

represent acceptable risk without the 

need for further more stringent controls. 

In the second step of the ample 

margin of safety framework under 

section 112(f)(2), we consider setting 

standards at a level which may be equal 

to, or lower than, the acceptable risk 

level and which protects public health 

with an ample margin of safety. In 

making the determination, we 

considered the estimate of health risk 

and other health information along with 

additional factors relating to the 

appropriate level of control, including 

costs and economic impacts of controls, 

technological feasibility, uncertainties, 

and other relevant factors. 

Because our conservative risk 

estimates suggest facilities in the 

category continue to pose risks 

exceeding 1-in-1 million after the 

application of MACT, we considered 

additional controls, such as new 

technology or alternative controls, to 

reduce emissions and associated risks. 

In 2001, while investigating the safety 

issue associated with chamber exhaust 

vents, we did not find any new 

technology or alternative controls for 

any of the vents—chamber, sterilizer or 

aeration room vents. We also found no 

data to support the addition of down 

stream control devices to existing 

control means as a way of further 

reducing emissions. This discussion can 

be found in our ‘‘Memorandum: 

Technology Review and Residual Risk 

Data Development for the Ethylene 

Oxide Commercial Sterilization 

NESHAP.’’ We concluded that further 

controls would not meaningfully reduce 

emissions from emission vents 

controlled with MACT at both major 

and area sources. 

While no additional control measures 

for emission vents controlled with 

MACT have been identified that would 

result in a meaningful reduction of 

emissions, we are aware of existing 

State rules which have control limits 

exceeding the 99 percent MACT 

requirement. The State of California’s 

emissions reductions requirement for 

the main sterilizer vent is 99.9 percent; 

this requirement was enacted prior to 

promulgation of the Federal 

requirements. 

We do not have data to confirm that 

all facilities are capable of achieving 

99.9 percent on a continuous basis. In 

1994, in support of the Federal control 

limit, we concluded both rules are 

sufficiently stringent to require 

application of the same technologies. 

We concluded it reasonable to assume 

the same technologies perform 

similarly, i.e., those facilities outside of 

California are on average likely to 

achieve emissions reductions similar to 

61408 Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Proposed Rules 

those in California. We concluded that 

tightening the current standards would 

not meaningfully reduce risks. 

The EPA requests comments 

specifically addressing our conclusion 

that the tightening of the current 

standards would not meaningfully 

reduce emissions or risks. Both EPA’s 

and California’s rules require a test to 

demonstrate compliance with the 

emissions reductions limit and 

continuous monitoring of the control 

equipment to ensure proper operation 

and maintenance. Initial compliance 

tests are performed one time and on a 

very narrow set of operating conditions. 

The test results are too limited to 

determine if there are any meaningful 

differences in control technology 

lifetime performance associated with a 

99 percent and 99.9 percent 

performance limit. Specifically, there 

are several questions on which we are 

requesting public comment: 

• Are there available test data 

demonstrating achievability of 99.9 

percent emissions reductions on a 

continuous basis for the main sterilizer 

vent? 

• Are there available test data 

demonstrating a meaningful difference 

in lifetime control performance between 

the same technology when it is subject 

to either the 99 or 99.9 percent 

emissions reductions requirement? 

• Are there available test data 

demonstrating all similar existing 

control technology is capable of 

achieving 99.9 percent emissions 

reductions on a continuous basis? 

• Are there available data showing 

the variance in long-term performance 

for similar technology complying with 

the 99 or 99.9 percent emissions 

reductions limit? 

• Are there additional costs 

associated with increasing the percent 

reduction from 99 to 99.9 percent? 

We also considered prohibiting the 

use of ethylene oxide for new facilities, 

which would necessitate the use of an 

alternative sterilization process. The 

Food and Drug Administration (FDA) 

has primary authority to regulate the use 

of sterilization methods. The FDA 

issued guidance (510(k) Sterility Review 

Guidance K90–1, August 30, 2002 

(‘‘FDA Guidance’’)) to facilitate 

nontraditional sterilization methods. 

The FDA stated in the guidance that the 

FDA ‘‘has had little or no experience 

with these methods for achieving 

sterilization and is concerned about a 

manufacturer’s ability to successfully 

use such methods without adversely 

affecting the sterility assurance level 

* * *.’’ If the use of ethylene oxide 

were prohibited, manufacturers of 

products requiring sterilization would 

have to reconsider the device and 

packaging material, its compatibility 

with the nontraditional sterilizing agent, 

the packaging configuration, the ability 

of the nontraditional sterilant to 

penetrate the packaging, the cost, and 

availability. Because these 

nontraditional sterilization methods are 

less known, manufacturers would have 

to submit to FDA their validation data 

for review. Nontraditional sterilization 

operations cannot be used to sterilize 

materials until they have been 

validated. Prohibiting the use of 

ethylene oxide carries the risk of 

creating a void where some products 

may not be able to be sterilized until 

newer systems are designed and 

validated. Until such time as these 

nontraditional sterilization techniques 

may be used under FDA rules, these 

techniques are not considered available 

for the purpose of reducing emissions. 

Radiation (gamma and electron beam) 

can be used to sterilize many products. 

Radiation sterilization has been used for 

about half of the products sterilized in 

the U.S. However, these sterilization 

techniques are limited in their 

applications. For example, gamma 

radiation has potentially damaging 

effects on products, particularly those 

products that contain polymers. And, 

radiation technology is completely 

different from chamber sterilization. 

Ethylene oxide and radiation 

technologies (both gamma and e-beam) 

share no common equipment. Any 

conversion would involve scrapping the 

ethylene oxide chambers and the related 

specialized equipment and systems, and 

likely displacing the existing workforce. 

Additionally, the ethylene oxide 

sterilization facility would not meet 

requirements for a radiation facility. To 

construct a radiation facility, special 

shielding (huge concrete/lead shields) 

and storage pools need to be 

incorporated into the design of both the 

building and the process. 

As stated previously, further controls 

for emission vents controlled with 

MACT at both major and area sources 

do not meaningfully reduce emissions 

or the corresponding risks. Further, the 

review has shown that both the 

noncancer and acute risks from this 

source category are below their relevant 

health thresholds. As a result, we 

conclude that no additional control 

should be required because an ample 

margin of safety (considering cost, 

technical feasibility, and other factors) 

has been achieved by the national 

emission standards. 

Thus, we conclude that the level of 

risk resulting from the limits in the 

national emission standards is 

acceptable for these source categories, 

and that changes to the national 

emission standards are not required to 

satisfy section 112(f) of the CAA. 

As discussed above, the EPA is 

developing a cancer unit risk estimate 

for ethylene oxide. If the EPA value 

becomes available before the 

promulgation of the final rule, we will 

reevaluate whether the risks are 

acceptable and whether an ample 

margin of safety has been achieved. 

F. How are we addressing GACT at area 

sources for purposes of section 112(f)? 

As noted above, section 112(f)(5) 

provides that EPA may, but is not 

required to, conduct any review under 

section 112(f) or promulgate any 

emissions limitations under that 

subsection for any area source for which 

an emissions standard is promugated as 

GACT. The CAA clearly permits EPA to 

review area source emissions under 

section 112(f)(2), even when the agency 

issued GACT standards under section 

112(d)(5) during its initial review. What 

is less clear is what the approach should 

be when the agency has ‘‘mixed’’ its 

emission standards (i.e., issued both 

MACT and GACT standards) for an area 

source category. In this instance, for 

example, EPA has issued MACT 

standards, under section 112(d)(1), for 

sterilizer vents and chamber exhaust 

vents; and GACT standards, under 

section 112(d)(5), for aeration room 

vents. This leaves open the question of 

which emissions points should be 

reviewed under a subsequent section 

112(f)(2) review. In this instance, EPA 

has undertaken an analysis under 

section 112(f)(2) for the area emissions 

standards that were issued as MACT 

standards, but the Agency has exercised 

its discretion and chosen not to perform 

an section 112(f)(2) analysis for those 

emissions points for which we 

established GACT. The Agency may 

have other alternatives legally available, 

however. For example, because the 

Administrator is not required to perform 

a residual risk analysis for any area 

source category when the Agency has 

previously promulgated ‘‘an emissions 

standard’’ pursuant to section 112(d)(5), 

it is at least arguable that, by using the 

singular article ‘‘an,’’ Congress intended 

to permit the Agency discretion to 

decline to review the area source 

category, in its entirety, under section 

112(f)(2) in appropriate ‘‘mixed’’ cases. 

The Agency seeks comment on the 

Agency’s range of discretion under 

section 112(f)(5) and suggestions on 

what factors should guide decisions 

about its approach in future 

rulemakings. 

Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Proposed Rules 61409 

G. What are the results of the technology 

review? 

Section 112(d)(6) of the CAA requires 

us to review and revise as necessary 

(taking into account developments in 

practices, processes, and control 

technologies) emission standards 

promulgated under this section no less 

often than every 8 years. In the course 

of our review, we investigated emission 

control levels and the potential for 

additional emissions reductions from 

existing affected facilities within the 

ethylene oxide commercial sterilization 

source category. Because the three vents 

associated with these facilities (i.e., the 

main sterilization, aeration room, and 

chamber exhaust emission vents) are the 

same for both major and area sources, 

the conclusions concerning technology 

apply to both source categories. We 

found that additional controls for 

emission vents controlled with either 

MACT or GACT would achieve at best, 

minimal emission and risk reductions at 

a very high cost. In our review, we did 

not identify any significant 

developments in practices, processes, or 

control technologies since promulgation 

of the national emission standards in 

1994. 

For new major sources where MACT 

requires emissions reductions of 99 

percent, we considered increasing the 

emissions reductions limit to 99.9 

percent in the national emission 

standards. A new limit would only 

apply to affected new sources (a new 

facility for the standards), while existing 

sources would still be subject to the 

current limits. As stated previously, we 

do not have data to confirm that 

facilities are capable of achieving 99.9 

percent on a continuous basis. 

Therefore, the 99 percent emissions 

reductions requirement of the national 

emission standards is considered to be 

the best control level in practice 

nationally. We conclude that the new 

source standard for the emissions 

reductions limit should be kept the 

same as that for existing, and that no 

further revisions to the National 

Emission Standards for Ethylene Oxide 

Sterilization Facilities are needed. 

In the original generally GACT 

determination for new area sources, no 

control requirements were established 

due to the high cost (59 FR 10598–99). 

In our review, we did not identify any 

significant developments in practices, 

processes, or control technologies since 

promulgation of the national emission 

standards in 1994 which would reduce 

the costs of applying controls to new 

area sources. 

Because the national emission 

standards continue to represent the best 

controls that can be implemented 

nationally, we are proposing not to 

revise the National Emission Standards 

for Ethylene Oxide Sterilization 

Facilities under CAA section 112(f) or 

112(d)(6). 

II. 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 regulation is 

‘‘significant’’ and, therefore, subject to 

Office of Management and Budget 

(OMB) review and the requirements of 

the Executive Order. The Executive 

Order defines ‘‘significant regulatory 

action’’ as one that is likely to result in 

a rule that may: 

(1) Have an annual effect on the 

economy of $100 million or more, or 

adversely affect in a material way the 

economy, a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

State, local, or tribal government 

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 or policy issues arising 

out of legal mandates, the President’s 

priorities, or the principles set forth in 

the Executive Order. 

It has been determined that today’s 

proposed decision is a ‘‘significant 

regulatory action’’ under the terms of 

Executive Order 12866 because it raises 

novel legal or policy issues arising out 

of legal mandates, the President’s 

priorities, or the principles set forth in 

the Executive Order. Therefore, today’s 

proposed decision was submitted to 

OMB for review. However, today’s 

proposed decision will result in no 

additional cost impacts beyond those 

estimated for the current national 

emission standards. 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 new 

information collection burden under the 

provisions of the Paperwork Reduction 

Act, 44 U.S.C. et seq. Today’s proposed 

decision will not change the burden 

estimates from those developed and 

approved for the national emission 

standards. In 1994, OMB approved the 

information collection requirements for 

the national emission standards under 

the provisions of the Paperwork 

Reduction Act, 44 U.S.C. 3501 et seq., 

and assigned OMB control number 

2060–0283. 

Burden means the total time, effort, or 

financial resources expended by persons 

to generate, maintain, retain, or disclose 

or provide information to or for a 

Federal agency. This includes the time 

needed to review instructions; develop, 

acquire, install, and utilize technology 

and systems for the purposes of 

collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; adjust the 

existing ways to comply with any 

previously applicable instructions and 

requirements; train personnel to be able 

to respond to a collection of 

information; search data sources; 

complete and review the collection of 

information; and transmit or otherwise 

disclose the information. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations are listed 

in 40 CFR part 9 and 48 CFR chapter 15. 

EPA has established a public docket 

for this action, which includes the ICR, 

under Docket ID number OAR 2003–

0197, which can be found in http:// 

www.epa.gov/edocket. Today’s 

proposed decision will not change the 

burden estimates from those developed 

and approved in 1994 for the national 

emission standards. 

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 impacts 

of today’s proposed decision on small 

entities, small entity is defined as: (1) A 

small business whose parent company 

has fewer than 100 or 1,500 employees, 

or a maximum of $5 million to $18.5 

million in revenues, depending on the 

size definition for the affected North 

American Industry Classification 

System (NAICS) code; (2) a small 

governmental jurisdiction that is a 

government of a city, county, town, 

school district or special district with a 

61410 Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Proposed Rules 

population of less than 50,000; and (3) 

a small organization that is any not-forprofit enterprise which is independently 

owned and operated and is not 

dominant in its field. It should be noted 

that the small business definition 

applied to each industry by NAICS code 

is that listed in the Small Business 

Administration (SBA) size standards (13 

CFR 121). 

After considering the economic 

impacts of today’s proposed decision on 

small entities, I certify that the decision 

will not have a significant economic 

impact on a substantial number of small 

entities. The proposed decision will not 

impose any requirements on small 

entities. Today’s proposal announces a 

decision and requests public comments 

on the residual risk assessment and 

technology review for the national 

emission standards and imposes no 

additional burden on facilities impacted 

by the national emission standards. We 

are proposing no further action at this 

time to revise the national emission 

standards. We continue to be interested 

in the potential impacts of the proposed 

decision on small entities and welcome 

comments on issues related to such 

impacts. 

D. Unfunded Mandates Reform Act 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA), Public 

Law 104–4, establishes requirements for 

Federal agencies to assess the effects of 

their regulatory actions on State, local, 

and tribal governments and the private 

sector. Under section 202 of the UMRA, 

EPA generally must prepare a written 

statement, including a cost-benefit 

analysis, for proposed and final rules 

with ‘‘Federal mandates’’ that may 

result in expenditures by State, local, 

and tribal governments, in 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 costeffective, 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 today’s 

proposed decision does not contain a 

Federal mandate that may result in 

expenditures of $100 million or more to 

State, local, and tribal governments in 

the aggregate, or to the private sector in 

any 1 year. Therefore, today’s proposed 

decision is not subject to the 

requirements of sections 202 and 205 of 

the UMRA. In addition, today’s 

proposed 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 proposed decision is not subject 

to 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’’ is defined in 

the Executive Order to include 

regulations that have ‘‘substantial direct 

effects on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’

Today’s proposed decision does 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. Thus, the 

requirements of the Executive Order do 

not apply to today’s proposed decision. 

F. Executive Order 13175, Consultation 

and Coordination With Indian Tribal 

Governments 

Executive Order 13175, entitled 

‘‘Consultation and Coordination with 

Indian Tribal Governments’’ (65 FR 

67249, November 6, 2000), requires EPA 

to develop an accountable process to 

ensure ‘‘meaningful and timely input by 

tribal officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive Order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

government and Indian tribes.’’

Today’s proposed decision does not 

have tribal implications. It will not have 

substantial direct effects 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 proposed decision. 

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 the 

Agency. 

Today’s proposed decision 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 risk addressed by this 

action present a disproportionate risk to 

children. 

H. Executive Order 13211: Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

Today’s proposed decision is not a 

‘‘significant energy action’’ as defined in 

Executive Order 13211 (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 

today’s proposed decision is not likely 

to have any adverse energy impacts. 

I. National Technology Transfer and 

Advancement Act of 1995 

Under section 12(d) of the National 

Technology Transfer and Advancement 

Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Proposed Rules 61411 

Act of 1995 (NTTAA), Public Law No. 

104–113, all Federal agencies are 

required to use voluntary consensus 

standards (VCS) in their regulatory and 

procurement activities unless to do so 

would be inconsistent with applicable 

law or otherwise impractical. Voluntary 

consensus standards are technical 

standards (e.g., materials specifications, 

test methods, sampling procedures, 

business practices) developed or 

adopted by one or more voluntary 

consensus bodies. The NTTAA requires 

Federal agencies to provide Congress, 

through annual reports to OMB, with 

explanations when the agency does not 

use available and applicable VCS. 

Today’s proposed decision does not 

involve technical standards. Therefore, 

the requirements of the NTTAA are not 

applicable. 

List of Subjects in 40 CFR Part 63 

Environmental protection, 

Administrative practice and procedures, 

Air pollution control, Intergovernmental 

relations, Reporting and recordkeeping 

requirements. 

Dated: October 18, 2005. 

Stephen L. Johnson, 

Administrator. 

[FR Doc. 05–21187 Filed 10–21–05; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 63 

[OAR–2004–0004, FRL–7987–4] 

RIN 2060–AK16 

National Emission Standards for 

Hazardous Air Pollutants for Industrial 

Process Cooling Towers 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed action; request for 

public comment. 

SUMMARY: On September 8, 1994, we 

promulgated national emission 

standards for hazardous air pollutants 

(NESHAP) from industrial process 

cooling towers (59 FR 46350). The 

NESHAP eliminated the use of 

chromium-based water treatment 

chemicals that are known or suspected 

to cause cancer or have a serious health 

or environmental effect. 

Section 112(f)(2) of the Clean Air Act 

(CAA) directs EPA to assess the risk 

remaining (residual risk) after the 

application of the NESHAP and 

promulgate additional standards if 

warranted to provide an ample margin 

of safety to protect public health or 

prevent an adverse environmental 

effect. Also, section 112(d)(6) of the 

CAA requires EPA to review and revise 

the NESHAP as necessary at least every 

8 years, taking into account 

developments in practices, processes, 

and control technologies. Based on our 

findings from the residual risk review 

and technology review, we are 

proposing no further action at this time 

to revise the NESHAP. This proposed 

action requests public comments on the 

residual risk review and technology 

review for the NESHAP. 

DATES: Comments. Comments must be 

received on or before December 8, 2005. 

Public Hearing. If anyone contacts 

EPA requesting to speak at a public 

hearing by November 8, 2005, a public 

hearing will be held approximately 20 

days following publication of this action 

in the Federal Register. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. OAR–2004–

0004, by one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Agency Web site: http:// 

www.epa.gov/edocket. EDOCKET, EPA’s 

electronic public docket and comment 

system, is EPA’s preferred method for 

receiving comments. Follow the on-line 

instructions for submitting comments. 

• E-mail: a-and-r-docket@epa.gov and 

mulrine.phil@epa.gov. 

• Fax: (202) 566–1741 and (919) 541–

5450. 

• Mail: U.S. Postal Service, send 

comments to: EPA Docket Center 

(6102T), Attention Docket Number 

OAR–2004–0004, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460. 

• Hand Delivery: In person or by 

courier, deliver comments to: EPA 

Docket Center (6102T), Attention Docket 

ID Number OAR–2004–0004, 1301 

Constitution Avenue, NW., Room B–

102, Washington, DC 20004. Such 

deliveries are only accepted during the 

Docket’s normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information. 

Please include a total of two copies. We 

request that a separate copy of each 

public comment also be sent to the 

contact person for the proposed action 

listed below (see FOR FURTHER

INFORMATION CONTACT). 

Instructions: Direct your comments to 

Docket ID No. OAR–2004–0004. The 

EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http:// 

www.epa.gov/edocket, including any 

personal information provided, unless 

the comment includes information 

claimed to be confidential business 

information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through EDOCKET, 

regulations.gov, or e-mail. The EPA 

EDOCKET and the Federal 

regulations.gov Web sites are 

‘‘anonymous access’’ systems, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through 

EDOCKET or regulations.gov, your email address will be automatically 

captured and included as part of the 

comment that is placed in the public 

docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. (For additional information 

about EPA’s public docket visit 

EDOCKET on-line or see the Federal 

Register of May 31, 2002 (67 FR 38102.) 

Docket: All documents in the docket 

are listed in the EDOCKET index at 

http://www.epa.gov/edocket. Although 

listed in the index, some information is 

not publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in EDOCKET or in hard 

copy at the EPA Docket Center, Docket 

ID Number OAR–2004–0004, EPA West 

Building, Room B102, 1301 Constitution 

Ave., NW., Washington, DC. The Public 

Reading Room is open from 8:30 a.m. to 

4:30 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Public Reading Room is 

(202) 566–1744, and the telephone 

number for the 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 proposed action, 

contact Mr. Phil Mulrine, U.S. EPA, 

Office of Air Quality Planning and 

Standards, Emission Standards 

Division, Metals Group (C439–02), 

Research Triangle Park, North Carolina