National Emission Standards for Hazardous Air Pollutants for Ethylene Oxide Commercial Sterilization and Fumigation Operations

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[AD-FRL-6500-2]

RIN 2060-A137

National Emission Standards for Hazardous Air Pollutants for

Ethylene Oxide Commercial Sterilization and Fumigation Operations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Interim final rule.

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SUMMARY: Today's action suspends the National Emission Standards for

Hazardous Air Pollutants for Ethylene Oxide Commercial Sterilization

and Fumigation Operations (EO NESHAP) requirements for chamber exhaust

and aeration room vents. The suspension allows affected sources subject

to the EO NESHAP to defer compliance with the NESHAP requirements for

chamber exhaust until December 6, 2001 and aeration room vents until

December 6, 2000. This suspension does not affect the requirement for

sources subject to the EO NESHAP to comply with provisions for

sterilizer vents. This action does not change the level of the

standards or the intent of the NESHAP promulgated in 1994.

DATES: This action is effective December 3, 1999. Comments may be

submitted until January 3, 2000.

ADDRESSES: Docket No. A-88-03, category VIII Amendments, contains

supporting information used in developing the standards. The docket is

located at the U.S. Environmental Protection Agency, 401 M Street, SW,

Washington, DC 20460 in room M-1500, Waterside Mall (ground floor), and

may be inspected from 8:30 a.m. to 5:30 p.m., Monday through Friday,

excluding legal holidays. This docket also contains information

considered by the EPA in proposing and promulgating the original EO

NESHAP.

FOR FURTHER INFORMATION CONTACT: For information concerning the

analysis performed in developing this interim rule, contact David W.

Markwordt at the Emission Standards Division (MD-13), U.S.

Environmental Protection Agency, Research Triangle Park, North Carolina

27711; telephone number (919) 541-0837, facsimile (919) 541-0942, e-

mail address [email protected].

SUPPLEMENTARY INFORMATION:

Docket

The docket is an organized file of information considered by the

EPA in the development of this rulemaking. The docket is a dynamic file

because material is added throughout the rulemaking process. The

docketing system is intended to allow members of the public and

industries involved to readily identify and locate documents so that

they can effectively participate in the rulemaking process. Along with

the proposed and promulgated standards and their preambles, the

contents of the docket will serve as the record in the case of judicial

review. (See section 307(d)(7)(A) of the Clean Air Act (Act).) The

regulatory text and other materials related to this rulemaking are

available for review in the docket or copies may be mailed on request

from the Air Docket by calling (202) 260-7548. A reasonable fee may be

charged for copying docket materials.

Judicial Review

Under section 307(b)(1) of the Clean Air Act (Act), judicial review

of this final action is available only by filing a petition for review

in the U.S. Court of Appeals for the District of Columbia Circuit

within 60 days of today's publication of this interim final rule. Under

section 307(b)(2) of the Act, the actions taken in today's notice may

not be challenged later in civil or criminal proceedings brought by the

EPA to enforce these requirements.

Technology Transfer Network

In addition to being available in the docket, an electronic copy of

today's interim final rule is also available through the Technology

Transfer Network (TTN). Following signature, a copy of the rule will be

posted on the TTN's policy and guidance page for newly proposed or

promulgated rules http://www.epa.gov/ttn/oarpg. The TTN provides

information and technology exchange in various areas of air pollution

control. If more information regarding the TTN is needed, call the TTN

HELP line at (919) 541-5384.

Regulated Entities

Regulated categories and entities include:

Table 1.--Regulated Categories and Entities

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Entity category Description/SIC code

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Industrial................................ Medical suppliers/3841,

3842, Pharmaceuticals/2834,

5122, 2831, 2833.

Spice manufactures/2099,

5149, 2034, 2035, 2046.

Contract Sterilizers/7399,

7218, 8091.

Federal Government........................ Not Affected.

State/Local/Tribal Gov.................... Not Affected.

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This table is not intended to be exhaustive, but rather provides a

guide for readers regarding entities regulated by the NESHAP addressed

in this interim final rule. If you have questions regarding the

applicability of the NESHAP addressed in this interim final rule to a

particular entity, consult the person listed in the preceding FOR

FURTHER INFORMATION section.

I. What Is the Background for This Suspension?

On December 6, 1994, we promulgated the EO NESHAP which regulates

emissions of ethylene oxide from new and existing commercial

sterilization and fumigation operations using 1 ton or more of EO per

year (59 FR 62585). The regulated category and entities affected by

today's action are the sources described in 40 CFR 63.360. That

provision includes commercial operations using ethylene oxide as a

[[Page 67790]]

sterilant and fumigant in the production of medical equipment and

supplies, and in miscellaneous sterilization and fumigation operations

at both major and area sources. Note that this description is not

intended to be exhaustive but, rather, to provide a guide for readers

interested in this suspension. To determine whether your facility is

affected by today's action, you should carefully examine the

applicability criteria in 40 CFR 63.360 and the explanation provided in

this interim final rule. If you have questions about the applicability

of today's action to a particular entity, consult the appropriate

person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

In July 1997, we learned of reports of explosions at ethylene oxide

sterilization and fumigation facilities. We subsequently suspended the

EO NESHAP for 1 year until December 6, 1998 to provide time to

determine the appropriate action necessary to mitigate the cause of the

explosions (62 FR 64736).

After becoming aware of the explosions, the industry worked through

the Ethylene Oxide Sterilization Association (EOSA) to begin

investigations. The EOSA established a Safety Committee in September

1997 which has been meeting on a bimonthly basis since then.

Sterilization industry leaders, abatement device vendors, and Federal,

State and local agencies have been participating in the Safety

Committee meetings.

In a June 2, 1998 letter to EPA, the EOSA recommended, ``additional

time to consider safe and economical control, installation, operation

and maintenance alternatives applicable to aeration and chamber exhaust

(backvent) emissions * * *'' (see Docket No. A-88-03). The Health

Industries Manufacturers Association (HIMA) reviewed the

recommendation. The EOSA and HIMA membership represent most of the

ethylene oxide sterilization and fumigation industry. The EOSA

``concluded that the oxidizer systems had not been properly integrated

with traditional ethylene oxide sterilization process operations, that

is, installation, operation and maintenance issues had not been

sufficiently addressed by sterilizer operators.'' The EOSA also

concluded that ``improperly overfeeding the oxidizer system from the

chamber backvent was the primary safety concern.''

We also conducted an independent investigation of the accidents and

reviewed reports prepared by EPA Regional Offices and by EOSA member

sterilization companies and, based on that investigation and review,

concurred with the industry conclusion and recommendation (see Docket

No. A-88-03). We further suspended the EO NESHAP for both aeration room

vents and chamber backvents for 1 year until December 6, 1999 to

provide time to determine the appropriate action necessary to mitigate

the cause of the explosions (63 FR 66990). Aeration room vents were

included in the suspension because control systems typically integrate

both vents to the same control device.

II. What Is the Rationale for Today's Suspension of Chamber Exhaust

and Aeration Room Vent Requirements?

As noted above, in July 1997, the Agency learned of reports of

explosions at ethylene oxide facilities. Several of these explosions

occurred at facilities subject to the EO NESHAP. The Agency immediately

began conducting a preliminary investigation to determine if the

emission control equipment mandated by 40 CFR part 63, subpart O, was

in any way associated with the cause of the problems at these

facilities. The Agency, on December 9, 1997, wishing to adopt a

cautious approach in order to assure public and worker safety,

published in the Federal Register an interim final rule suspending 40

CFR part 63, subpart O (62 FR 64736). Since publication of the December

9, 1997 rule, both EPA and industry have continued to investigate the

cause of the accidents.

In 1998, the Agency agreed with industry that, in the cases where

explosions occurred, the catalytic oxidizer units were overfed with

ethylene oxide in concentrations above the safe operations limit due to

abnormal activation of the chamber exhaust (backvent). The Agency

concluded that main vent emissions routed through the vacuum pump

played no role in the explosions. The Agency also concluded that any

emissions control technology necessary to comply with the EO NESHAP

needs to be properly integrated into the sterilization system and

operations and must reflect the full range of normal and abnormal

conditions that may occur.

The suspension, in December 1998, for chamber exhaust vents was

based on the assumption that sterilization chamber operators would be

able to evaluate and integrate the emission control technology with

sterilizer operation to ensure prevention of future explosions by

December 6, 1999. To date, solutions to the safety problems have not

been developed. Consequently, the EOSA and individual plant operators

have requested EPA to eliminate the requirement for backdraft vents

(see Docket No. A-88-03).

It is beyond the Agency's legal mandate and technical expertise to

certify equipment for safe use. The Clean Air Act generally requires

the Agency to assess existing emission control technology for

application to non-controlled emission sources. The use of existing

technology by some sources in the relevant category presumes the

ability to operate that technology in a proven safe manner. At the time

of promulgation (December 1994), state-of-the-art control technology

for chamber exhaust emissions apparently involved safety hazards not

known at that time. Therefore, the Agency will reconsider its original

MACT determination for chamber exhaust vents and propose a course of

action in the near future.

Today's 2-year suspension of control requirements for chamber

exhaust emissions is based on the anticipated time required to propose

and promulgate changes in the Federal Register. It's our intent to

resolve this matter as quickly as possible, and we hope to finalize a

revised rule in less than 2 years.

Today's 1-year suspension of control requirements for aeration room

vents is based on the fact that many facilities are routing chamber

exhaust emissions to the emission control device for aeration room

vents. Facilities that control both aeration and chamber exhaust

emissions via one abatement device will need to disconnect the chamber

exhaust vent from the aeration room control device. Therefore, the

Agency is providing time to separate chamber exhaust emissions from

integrated control systems, if needed.

In this matter, we wish to err, if at all, on the side of safety.

Accordingly, we are, today, further suspending the EO NESHAP emission

limitation requirements in 40 CFR part 63, subpart O, for chamber

exhaust and aeration room vents, as those emission points are defined

at 40 CFR 63.361, until December 6, 2001 and December 6, 2000,

respectively, pursuant to our general rulemaking authority under

section 301(a) of the Act, 42 U.S.C. 7601(a). Sources must continue to

comply with the EO NESHAP emission limitation requirements in 40 CFR

part 63, subpart O, for sterilization chamber vents, as those emission

points are defined at 40 CFR 63.361, because we have determined that

their controls do not pose a safety concern.

Section 301(a) of the Act grants the Administrator of the EPA the

authority ``to prescribe such regulations as are necessary to carry out

his functions

[[Page 67791]]

under this Act.'' Given the unique circumstances and uncertainty

surrounding the EO NESHAP, as described in this interim final rule, EPA

believes that it is necessary to further suspend this rule's

requirements for chamber exhaust and aeration room vents for the safety

of the public and workers in and around EO facilities. The control

requirements of the EO NESHAP for chamber exhaust and aeration room

vents continue to pose potential safety problems for which viable

solutions are not currently available. This action is consistent with

the objectives of the Act as stated in section 101(b), 42 U.S.C.

7401(b), ``(T)he purposes of this subchapter are * * * to promote the

public health and welfare and the productive capacity of its population

* * *.''

The original EO NESHAP and today's interim final rule are

promulgated pursuant to section 307(d) of the Act, 42 U.S.C. 7607(d),

which requires that any rule subject to that section be issued only

after the public has received notice of, and an opportunity to comment

on, the rule. However, section 307(d)(1) exempts from those

requirements any rule for which the Agency finds under the

Administrative Procedure Act, 5 U.S.C. 553(b), that providing prior

notice-and-comment would be impracticable, unnecessary or contrary to

the public interest.

We believe the circumstances presented here provide good cause to

take this action without prior notice-and-comment. We find providing

prior notice-and-comment would be impracticable and contrary to the

public interest based on the potential ongoing danger to public and

worker safety posed by the recent incidents at ethylene oxide

facilities. There is simply not enough time to provide notice-and-

comment procedures before the current compliance date of December 6,

1999 arrives, and until the compliance date is extended, sources are

faced with having to install control equipment in time to meet the

current compliance date. Only by omitting notice-and-comment from this

action can we provide sources affected by the EO NESHAP with timely

legal relief from the current compliance date while we further

investigate the situation. Consequently, this action is being

promulgated without prior notice-and-comment as provided for in section

307(b)(1) of the Act and is immediately effective as provided for in

section 112(d)(10) of the Act.

Nonetheless, we are providing 30 days for submission of public

comments. We will consider all written comments submitted in the

allotted time period to determine if any change to this action is

necessary.

In suspending the EO NESHAP requirements for chamber exhaust and

aeration room vents, the Administrator wishes to remind the public and

the regulated community that the role of the EPA has been and continues

to be protection of public health and the environment in a way that is

consistent with safety concerns.

III. Administrative Requirements

A. Paperwork Reduction Act

The information collection requirements of the EO NESHAP were

submitted to and approved by the Office of Management and Budget (OMB).

A copy of this Information Collection Request (ICR) document (OMB

control number 2060-0283) may be obtained from Ms. Sandy Farmer,

Information Policy Branch (2136), U.S. EPA, 401 M Street, SW,

Washington, DC 20460, or by calling (202) 260-2740.

Today's action has no impact on the information collection burden

estimates made previously. Today's action merely suspends the EO NESHAP

requirements for chamber exhaust and aeration room vents for 1 year.

This change does not impose new requirements. Consequently, the ICR has

not been revised.

B. Executive Order 12866

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

must determine whether the regulatory action is ``significant'' and

therefore subject to review by OMB on the basis of the requirements of

the Executive Order in addition to its normal review requirements. 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 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.

Today's action does not fall within any of the four categories

described above. Instead, it reduces the burden on certain sources by

temporarily suspending the EO NESHAP requirements for chamber exhaust

and aeration vents. Consequently, under Executive Order 12866, this

action is not a ``significant regulatory action'' and is therefore not

subject to review by OMB.

C. Executive Order 13132

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.'' Under

Executive Order 13132, EPA may not issue a regulation that has

federalism implications, that imposes substantial direct compliance

costs, and that is not required by statute, unless the federal

government provides the funds necessary to pay the direct compliance

costs incurred by State and local governments, or EPA consults with

State and local officials early in the process of developing the

proposed regulation. The EPA also may not issue a regulation that has

federalism implications and that preempts State law unless the Agency

consults with State and local officials early in the process of

developing the proposed regulation.

If EPA complies by consulting, Executive Order 13132 requires EPA

to provide to OMB, in a separately identified section of the preamble

to the rule, a federalism summary impact statement (FSIS). The FSIS

must include a description of the extent of EPA's prior consultation

with State and local officials, a summary of the nature of their

concerns and the Agency's position supporting the need to issue the

regulation, and a statement of the extent to which the concerns of

State and local officials have been met. Also, when EPA transmits a

draft final rule with federalism implications to OMB for review

pursuant to Executive Order 12866, EPA must include a certification

from the agency's Federalism Official stating that EPA has met the

requirements of Executive Order 13132 in a meaningful and timely

manner.

This final rule will not have substantial direct effects on the

States,

[[Page 67792]]

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. Today's

action suspends existing requirements which were promulgated in

December 1994. There are minimal, if any, impacts associated with this

action, thus, the requirements of section 6 of the Executive Order do

not apply to this rule.

D. Regulatory Flexibility/Small Business Regulatory Enforcement

Fairness Act of 1996

Under the Regulatory Flexibility Act, Pub. L. 96-354, whenever an

Agency publishes any proposed or final rule in the Federal Register, it

must, except under certain circumstances, prepare a Regulatory

Flexibility Analysis (RFA) that describes the impact of the rule on

small entities (i.e., small businesses, organizations, and governmental

jurisdictions). That analysis is not necessary if the Agency determines

that the rule will not have a significant economic impact on a

substantial number of small entities.

The EPA believes that there will be little or no adverse impact on

any small entities as a result of the promulgation of this rule

because, rather than imposing additional requirements, this rule

provides additional time to comply with parts of the EO NESHAP. Because

the impacts are anticipated to be insignificant or beneficial, EPA has

concluded that this rule will not have a significant economic impact on

a substantial number of small entities. Consequently, an RFA is not

required.

E. Unfunded Mandates Reform Act

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public

Law 104-4, establishes requirements for Federal agencies to assess the

effects of their regulatory actions on State, local, and tribal

governments and the private sector. Under section 202 of the UMRA, EPA

generally must prepare a written statement, including a cost-benefit

analysis, for proposed and final rules with ``Federal mandates'' that

may result in expenditures to State, local, and tribal governments, in

the aggregate, or to the private sector of $100 million or more in any

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 objects 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.

Today's rule contains no Federal mandates (under the regulatory

provisions of Title II of the UMRA) for State, local, or tribal

governments or the private sector. Instead, this rule provides

additional time to comply with some requirements of the EO NESHAP.

Because the rule is not expected to result in the expenditure by State,

local, and tribal governments or the private sector of $100 million or

more in any 1 year, the Agency has not prepared a budgetary impact

statement or specifically addressed the selection of the least costly,

most effective, or least burdensome alternative. Because small

governments will not be significantly or uniquely affected by this

rule, the Agency is not required to develop a plan with regard to small

governments. For the reasons stated above, the requirements of the UMRA

do not apply to this section.

F. National Technology Transfer and Advancement Act

Section 12 of the National Technology Transfer and Advancement Act

of 1995 (NTTAA) requires Federal agencies to evaluate existing

technical standards when developing new regulations. To comply with the

NTTAA, EPA must consider and use ``voluntary consensus standards''

(VCS) if available and applicable when developing programs and policies

unless doing so would be inconsistent with applicable law or otherwise

impractical.

The EPA believes that the use of VCS in this interim final rule is

impractical. The suspension of the EO NESHAP requirements for chamber

exhaust and aeration room vents is merely a procedural action that does

not require sources to take substantive steps that lend themselves to

VCS.

G. Executive Order 13045

Executive Order 13045, entitled Protection of Children from

Environmental Health Risks and Safety Risks (62 FR 19885, April 23,

1997), applies to any rule that (1) OMB determines is ``economically

significant'' as defined under Executive Order 12866, and (2) EPA

determines the environmental health or safety risk addressed by the

rule has a disproportionate effect on children. If the regulatory

action meets both criteria, the Agency must evaluate the environmental

health or safety aspects of the planned rule on children, and explain

why the planned regulation is preferable to other potentially effective

and reasonably feasible alternatives considered by the Agency.

This interim final rule is not subject to the Executive Order

because it is not economically significant as defined in E.O. 12866,

and because the Agency does not have reason to believe the

environmental health or safety risks addressed by this action present a

disproportionate risk to children.

H. Executive Order 13084

Under Executive Order 13084, EPA may not issue a regulation that is

not required by statute, that significantly or uniquely affects the

communities of Indian tribal governments, and that imposes substantial

direct compliance costs on those communities, unless the Federal

government provides the funds necessary to pay the direct compliance

costs incurred by the tribal governments, or EPA consults with those

governments. If EPA complies by consulting, Executive Order 13084

requires EPA to provide to the Office of Management and Budget, in a

separately identified section of the preamble to the rule, a

description of the extent of EPA's prior consultation with

representatives of affected tribal governments, a summary of the nature

of their concerns, and a statement supporting the need to issue the

regulation. In addition, Executive Order 13084 requires EPA to develop

an effective process permitting elected officials and other

representatives of Indian tribal governments ``to provide meaningful

and timely input in the development of regulatory policies on matters

that significantly or uniquely affect their communities.''

Today's rule does not significantly or uniquely affect the

communities of Indian tribal governments. This interim final rule

imposes no enforceable duties on these entities. Rather, the interim

[[Page 67793]]

final rule temporarily suspends certain regulatory requirements.

Accordingly, the requirements of section 3(b) of Executive Order 13084

do not apply to this rule.

I. Congressional Review Act

Under the Small Business Regulatory Enforcement Fairness Act of

1996, we submitted a report containing these final amendments and other

required information to the U.S. Senate, the U.S. House of

Representatives, and the Comptroller General of the General Accounting

Office prior to publication of these final amendments in the Federal

Register. This is not a ``major rule'' as defined by the Small Business

Regulatory Enforcement Fairness Act.

List of Subjects in 40 CFR Part 63

Environmental protection, Air pollution control, Ethylene oxide

sterilization, Hazardous substances, Reporting and recordkeeping

requirements.

Dated: November 29, 1999.

Carol M. Browner,

Administrator.

For the reasons set out in the preamble, title 40, chapter I, of

the Code of Federal Regulations is amended as follows:

PART 63--[AMENDED]

1. The authority citation for part 63 continues to read as follows:

Authority: 42 U.S.C. 7401, et seq.

Subpart O--[Amended]

2. Section 63.360 is amended by revising paragraphs (g)(4), (g)(5),

and (g)(6) and adding paragraphs (g)(7), (g)(8), (g)(9), and (g)(10) to

read as follows:

Sec. 63.360 Applicability.

* * * * *

(g) * * *

(4) All aeration room vents subject to the emissions standards in

Sec. 63.362 with an initial startup date before December 6, 2000, no

later than December 6, 2000.

(5) All aeration room vents subject to the emissions standards in

Sec. 63.362 with an initial startup date on or after December 6, 2000,

immediately upon initial startup of the source.

(6) All aeration room vents at sources using less than 10 tons that

increase their ethylene oxide usage after December 6, 2000, such that

the aeration room vents become subject to the emissions standards in

Sec. 63.362, immediately upon becoming subject to the emission

standards.

(7) All chamber exhaust vents subject to the emissions standards in

Sec. 63.362 with an initial startup date before December 6, 2001, no

later than December 6, 2001.

(8) All chamber exhaust vents subject to the emissions standards in

Sec. 63.362 with an initial startup date on or after December 6, 2001,

immediately upon initial startup of the source.

(9) All chamber exhaust vents at sources using less than 1 ton that

increase their ethylene oxide usage after December 6, 2001, such that

the chamber exhaust vents become subject to the emissions standards in

Sec. 63.362, immediately upon becoming subject to the emission

standards.

(10) All chamber exhaust vents at sources using less than 10 tons

that increase their ethylene oxide usage after December 6, 2001, such

that the chamber exhaust vents become subject to the emissions

standards in Sec. 63.362(e)(1), immediately upon becoming subject to

the emission standards.

* * * * *

[FR Doc. 99-31354 Filed 12-2-99; 8:45 am]

BILLING CODE 6560-50-P