13464 Federal Register / Vol. 66, No. 44 / Tuesday, March 6, 2001 / Proposed Rules

significant economic impact on a

substantial number of small entities as

they are defined in the Regulatory

Flexibility Act, 5 U.S.C. 601–612. This

proposed rule does not affect small

businesses. Therefore, pursuant to 5

U.S.C. 605(b), this rule is exempt from

the initial and final regulatory flexibility

analyses requirements of sections 603

and 604.

List of Subjects in 38 CFR Part 19

Administrative practice and

procedure, Claims, Veterans.

Dated: February 21, 2001.

Anthony J. Principi,

Secretary of Veterans Affairs.

For the reasons set out in the

preamble, we propose to amend 38 CFR

part 19 as set forth below:

PART 19—BOARD OF VETERANS’

APPEALS: APPEALS REGULATIONS

1. The authority citation for part 19

continues to read as follows:

Authority: 38 U.S.C. 501(a), unless

otherwise noted.

2. Section 19.2 is revised to read as

follows:

§ 19.2 Composition of the Board; Titles.

(a) The Board consists of a Chairman,

Vice Chairman, Deputy Vice Chairmen,

Members and professional,

administrative, clerical and

stenographic personnel. Deputy Vice

Chairmen are Members of the Board

who are appointed to that office by the

Secretary upon the recommendation of

the Chairman.

(b) A Member of the Board (other than

the Chairman) may also be known as a

Veterans Law Judge. An individual

designated as an acting Member

pursuant to 38 U.S.C. 7101(c)(1) may

also be known as an acting Veterans

Law Judge.

(Authority: 38 U.S.C. 501(a), 512, 7101(a)).

[FR Doc. 01–5452 Filed 3–5–01; 8:45 am]

BILLING CODE 8320–01–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 63

[AD–FRL–6950–9]

RIN 2060–AC28

Ethylene Oxide Emissions Standards

for Sterilization Facilities

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed amendments.

SUMMARY: This proposal amends the

emission standards for sterilization

facilities by eliminating maximum

achievable control technology (MACT)

requirements for chamber exhaust vents.

This action is being proposed to

eliminate safety problems associated

with the existing requirements. This

proposal also amends testing and

monitoring requirements for

sterilization chamber, aeration, and

chamber exhaust vents. Specific testing

and monitoring requirements are being

removed or simplified to correct

technical problems associated with the

existing requirements.

DATES: Submit comments on or before

May 7, 2001.

Public hearing. If anyone contacts the

EPA requesting to speak at a public

hearing by March 26, 2001, a public

hearing will be held on April 5, 2001.

ADDRESSES: Comments. Written

comments should be submitted (in

duplicate if possible) to: Air and

Radiation Docket and Information

Center (6102), Attention Docket Number

A–88–03, U.S. EPA, 401 M Street, SW,

Washington, DC 20460. The EPA

requests a separate copy also be sent to

the contact person listed below (see FOR

FURTHER INFORMATION CONTACT).

Docket. Docket No. A–88–03 contains

supporting information used in

developing the standards. The docket is

located at the U.S. EPA, 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.

Public Hearing. If a public hearing is

held, it will be held at 10 a.m. in the

EPA’s Office of Administration

Auditorium, Research Triangle Park,

North Carolina, or at an alternate site

nearby.

FOR FURTHER INFORMATION CONTACT:

David Markwordt, Policy, Planning, and

Standards Group, Emission Standards

Division, (MD–13), U.S. EPA, Research

Triangle Park, North Carolina 27711,

telephone number (919) 541–0837,

electronic mail address

markwordt.david@epa.gov.

SUPPLEMENTARY INFORMATION:

Comments. Comments and data may be

submitted by electronic mail (e-mail) to:

a-and-r-docket@epa.gov. Electronic

comments must be submitted as an

ASCII file to avoid the use of special

characters and encryption problems and

will also be accepted on disks in

WordPerfect version 5.1, 6.1 or Corel 8

file format. All comments and data

submitted in electronic form must note

the Docket No. A–88–03. No

confidential business information (CBI)

should be submitted by e-mail.

Electronic comments may be filed

online at many Federal Depository

Libraries.

Commenters wishing to submit

proprietary information for

consideration must clearly distinguish

such information from other comments

and clearly label it as CBI. Send

submissions containing such

proprietary information directly to the

following address, and not to the public

docket, to ensure that proprietary

information is not inadvertently placed

in the docket: Attention: David

Markwordt, C/O OAQPS Document

Control Officer, U.S. Environmental

Protection Agency, 411 W. Chapel Hill

Street, (Room 740B), Durham NC 27701.

The EPA will disclose information

identified as CBI only to the extent

allowed by the procedures set forth in

40 CFR part 2. If no claim of

confidentiality accompanies a

submission when it is received by the

EPA, the information may be made

available to the public without further

notice to the commenters.

Public Hearing. Persons interested in

presenting oral testimony or inquiring

as to whether a hearing is to be held

should contact Dorothy Apple, Policy,

Planning, and Standards Group,

Emission Standards Division (MD–13),

U.S. EPA, Research Triangle Park, North

Carolina 27711, telephone number:

(919) 541–4487 at least 2 days in

advance of the public hearing. Persons

interested in attending the public

hearing must also call Dorothy Apple to

verify the time, date, and location of the

hearing. The public hearing will provide

interested parties the opportunity to

present data, views, or arguments

concerning these proposed emission

standards amendments.

Docket. The docket is an organized

and complete file of all the information

we considered 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

(CAA)). 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–

Federal Register / Vol. 66, No. 44 / Tuesday, March 6, 2001 / Proposed Rules 13465

7548. A reasonable fee may be charged

for copying docket materials. World

Wide Web (WWW). In addition to being

available in the docket, an electronic

copy of these proposed amendments

will also be available on the Technology

Transfer Network (TTN). Following

signature, a copy of the rule will be

posted on the 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 our HELP line at (919) 541–

5384.

Regulated Entities. Categories and

entities regulated by this action include:

Category SICa/NAICSb Examples of regulated entities

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

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

2099, 5149, 2034, 2035, 2046 ................................ Spice Manufactures Contract.

7399, 7218, 8091 ..................................................... Sterilizers.

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

State/Local/Tribal Gov .............................................. Not affected ..............................................................

aStandard Industrial Classification Code.

b North American Information Classification System.

This table is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities regulated

by the NESHAP addressed in these

proposed amendments. To determine

whether your facility is regulated by this

action, you should examine the

applicability criteria in § 63.360 of the

proposed rule. If you have questions

regarding the applicability of the

NESHAP addressed in this proposed

rule to a particular entity, consult the

person listed in the preceding FOR

FURTHER INFORMATION CONTACT section.

Outline. The information presented in

this preamble is organized as follows:

I. Chamber Exhaust Vents

A. Why are we reconsidering MACT for

chamber exhaust vents?

B. What is MACT for chamber exhaust

vents?

II. Monitoring

A. Why are we reconsidering the

monitoring requirements?

B. How are we proposing to amend the

monitoring requirements?

III. Testing

A. Why are we proposing to change the

testing requirements?

B. How are we proposing to amend the

testing requirements?

IV. Summary of Environmental, Energy, and

Economic Impacts

V. Administrative Requirements

A. Executive Order 12866, Regulatory

Planning and Review

B. Paperwork Reduction Act

C. Executive Order 13132, Federalism

D. Executive Order 13084, Consultation

and Coordination with Indian Tribal

Governments

E. Unfunded Mandates Reform Act of 1995

F. Regulatory Flexibility Act (RFA), as

Amended by the Small Business

Regulatory Enforcement Fairness Act of

1996 (SBREFA), 5 U.S.C. 601 et seq.

G. National Technology Transfer and

Advancement Act of 1995

H. Executive Order 13045, Protection of

Children from Environmental Health

Risks and Safety Risks

I. Chamber Exhaust Vents

A. Why Are We Reconsidering MACT for

Chamber Exhaust Vents?

On December 6, 1994, we

promulgated the ethylene oxide (EO)

national emission standards for

hazardous air pollutants (NESHAP)

which regulate emissions of ethylene

oxide from commercial sterilization and

fumigation operations (59 FR 62585). In

July 1997, we learned of explosions at

ethylene oxide sterilization and

fumigation facilities. We 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 continues to meet bimonthly.

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

* * *.’’ The Health Industries

Manufacturers Association (HIMA)

reviewed the recommendation.

Together, the EOSA and HIMA

memberships 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.’’

The EPA 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. In 1998, we 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). We concluded that

the main sterilizer vent emissions

routed through the vacuum pump

played no role in the explosions.

Therefore, the December 6, 1998

compliance date for the main sterilizer

vent was allowed to take effect.

However, we further suspended the EO

NESHAP for both aeration room vents

and chamber exhaust vents 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.

We 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; it must reflect

the full range of normal and abnormal

conditions that may occur. The

December 1998 suspension was based

on the assumption that sterilization

chamber operators would be able to

evaluate and integrate the emission

control technology with sterilizer

13466 Federal Register / Vol. 66, No. 44 / Tuesday, March 6, 2001 / Proposed Rules

operations to ensure prevention of

future explosions by December 6, 1999.

In June 1999, the EOSA and individual

plant operators requested that EPA

eliminate the control requirement for

chamber exhaust vents. In response to

the June 1999 request, we further

suspended the control requirements for

aeration and chamber exhaust vents on

December 3, 1999 (64 FR 67789).

We suspended the control

requirements for aeration room vents

because they are typically combined

with chamber exhaust vents and ducted

to a single control device. The December

3, 1999 notice (64 FR 67789) explained

that there is no safety issue associated

with controlling only the aeration room

vent; no revisions to control

requirements were anticipated. The

1999 notice also suspended the

compliance date for aeration room vents

by 1 year to provide time to decouple

them from any chamber exhaust vents.

Aeration room vents were required to

comply with the emission control

requirements by December 6, 2000.

However, the compliance date for the

chamber exhaust vent control

requirements was suspended until

December 6, 2001 in the 1999 notice (64

FR 67789). At the time we said, ‘‘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 operations to

ensure prevention of future explosions

by December 6, 1999. To date, solutions

to the safety problems have not been

developed.’’ We further stated that the

Agency would reconsider its original

MACT determination for chamber

exhaust vents and propose a course of

action in the near future.

In April 2000, a report jointly

published by the National Institute for

Occupational Safety and Health

(NIOSH), EPA, and the EOSA concluded

the following:

1. Fires and explosions result when

sterilizer oxidizing emission control

devices (OECD) are overfed with high

concentrations of ethylene oxide;

2. Current procedures for aborting the

ethylene oxide sterilizer cycle are

deficient when OECD are used;

3. Current safety systems for ethylene

oxide sterilization processes are

deficient when OECD are used; and

4. When OECD are used as the only

emission control device (that is, when

acidified wet scrubbers are not used or

are bypassed), the risk of fire and

explosion is greatly increased.

The conclusions in this report are

supportive of our conclusions in the

December 3, 1999 notice.

We are still in the position today of

being unable to make a finding that

solutions to the safety problems have

been developed. It is beyond the

Agency’s legal mandate and technical

expertise to certify equipment for safe

use. The CAA 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 rule promulgation

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

technology for chamber exhaust

emissions involved safety hazards not

known at the time.

We are aware that some companies

have removed their catalytic oxidizers

and replaced them with alternative

control devices. Some of these

alternative control devices operate

without a flame source and would

presumably be safer than systems which

rely on combustion. However, even noncombustion control devices must be

designed to avert potential safety

problems due to exothermic reaction

resulting from the control of ethylene

oxide. We are not aware of any

authoritative institution which has

evaluated these alternative systems for

safe operation.

B. What Is MACT for Chamber Exhaust

Vents?

In the preamble to the proposed

NESHAP (59 FR 10598), we explained

the basis of the MACT floor for chamber

exhaust vents. The available data

indicated that there were no chamber

exhaust vents routed to a control device;

we concluded that the MACT floor for

chamber exhaust vents at new and

existing major and area sources required

no reduction in emissions from these

vents. However, to ensure that the

current amount of ethylene oxide being

evacuated via the sterilization pump

continued to be routed to a control

device rather than exhausted via an

uncontrolled vent, the proposed

NESHAP incorporated a concentrationbased limit on emissions from chamber

exhaust.

In public comments received on the

proposed rule, an abatement device

vendor provided sufficient data to

establish a MACT floor consisting of

control requirements for chamber

exhaust vents at both existing and new

major sources. The vendor data listed

ethylene oxide sterilizer operations

using catalytic oxidizers for control of

chamber exhaust vents. No data

indicating the use of technology other

than catalytic oxidizers were supplied

to us. As described in the preamble to

the promulgated NESHAP (59 FR

62585), based on vendor data, we

required control of chamber exhaust

vent emissions at new and existing

major sources. However, at the time,

neither we nor the commercial sterilizer

industry were aware of the potential

safety issues associated with controlling

chamber exhaust vents.

Experience over the last 5 years

clearly demonstrates the oversimplification of controlling chamber

exhaust by simply ducting the vent

stream to a control device designed to

control aeration room vent emissions.

Based on what we have learned since

the explosions, it is clear that no one

was aware of the potential to overfeed

the aeration control with ethylene oxide

inadvertently routed from the chamber

exhaust. Control systems designed for

aeration room emissions had not been

designed to handle potentially large

quantities of ethylene oxide from

chamber exhaust malfunctions.

Obviously, appropriate safety design

features are necessary to make this

control approach acceptable as a viable

means of emissions reductions. The

same safety issue exists for control

devices dedicated exclusively to

chamber exhaust vent emissions.

The CAA requires that emission

standards for HAP established under

section 112(d) be based on ‘‘* * * the

maximum degree of reduction in

emissions of the hazardous air

pollutants subject to this section * * *

that the Administrator, taking into

consideration the cost of achieving such

emission reduction, and any non-air

quality health and environmental

impacts and energy requirements,

determines is achievable for new or

existing sources in the category or

subcategory to which such emission

standards applies * * *.’’ These

emission standards are commonly

referred to as MACT.

The requirement to consider ‘‘any

non-air quality health and

environmental impacts and energy

requirements’’ would necessarily

require control devices to be

intrinsically safe. Had we known of the

potential safety issue and known this

control approach was blind to the safety

issue, we would have refuted the

commenters’ assertion and made a

finding of MACT floor as no control of

chamber exhaust emissions. As stated

above, it is beyond the Agency’s legal

mandate and technical expertise to

certify equipment for safe use. Since no

one has demonstrated to the Agency’s

satisfaction that the equipment is safe

for this purpose, we are reconsidering

Federal Register / Vol. 66, No. 44 / Tuesday, March 6, 2001 / Proposed Rules 13467

our original MACT determination for

chamber exhaust vents.

Today, we are proposing that MACT

for chamber exhaust vents at major

sources should be no control. To ensure

that the current amount of ethylene

oxide being evacuated via the

sterilization pump continues to be

routed to a control device rather than

exhausted via an uncontrolled vent, we

are proposing a concentration-based

limit on emissions from major source

chamber exhaust vents. This is the same

requirement that was originally

proposed for the major sources and

currently applies to area sources.

II. Monitoring

A. Why Are We Reconsidering the

Monitoring Requirements?

Commercial sterilization facilities

subject to the rule were originally

required to demonstrate compliance by

June 8, 1998. Before that date, the

Agency received requests to clarify

specific testing and monitoring

requirements. Companies conducting

tests questioned how to determine the

level of the monitored temperature

which would be used to determine

compliance on a continuous basis.

There are three emission vents

associated with the sterilization process:

the sterilization chamber vent, the

aeration room vent, and the chamber

exhaust vent. The sterilization process

results in short-term episodic releases of

various concentrations of ethylene

oxide. The majority of facilities use

either scrubbers or catalytic oxidizers or

a combination of both to reduce

emissions.

Catalytic oxidizers combust ethylene

oxide, an exothermic reaction, which

increases the catalyst bed temperature.

The higher the concentration of

ethylene oxide fed to the catalytic

oxidizer, the higher the bed

temperature. The bed temperature

spikes during periods when higher

concentrations of ethylene oxide are fed

to the catalyst bed. Generally, a catalytic

oxidizer bed is designed to be at or

above a minimum temperature to be hot

enough to combust ethylene oxide when

it contacts the bed.

Sterilization chambers are filled with

the product to be sterilized and then

infused with ethylene oxide gas. The

ethylene oxide is pumped from the

chamber after completion of the

sterilization cycle. After the chamber is

evacuated, the chamber is flooded with

air to facilitate off-gassing of ethylene

oxide residing in the product. Then, the

chamber pump is turned on and the

chamber is evacuated again. This air

wash/evacuation cycle is repeated

multiple times. The amount of ethylene

oxide decreases with each subsequent

evacuation. For main sterilization vents

controlled with a catalytic oxidizer,

chamber evacuations cause temporary

spikes in catalyst bed temperature.

The existing rule requires a 99 percent

reduction in emissions for the main

sterilizer vent, and either a 99 percent

reduction in emissions or a 1 parts per

million per volume (ppmv) maximum

outlet concentration for aeration room

vents. For the main sterilizer vent, the

existing rule requires the operator to

demonstrate compliance with the 99

percent reduction requirement only

during the first evacuation.

The existing rule also requires

facilities to meet appropriate operating

limits to ensure continuous compliance

with the emission reduction

requirements. We did not establish the

relationship between any of the

operating limits and the emissions

reductions associated with the

technologies used in the industry.

Nearly all operators who had installed

controls prior to promulgation of the

final rule used either catalytic oxidizers

or acid scrubbers to reduce emissions.

Acid scrubbers are used primarily to

control the main sterilizer vent. The

existing rule requires monitoring of

either the ethylene oxide glycol

concentration of the scrubbing liquor or

the level of liquor in the scrubber tank.

Facilities could perform the initial

compliance test when the ethylene

glycol concentration or liquor level was

at the highest level at which the

emission reduction requirement could

be met. Both the ethylene glycol

concentration and liquor level increase

with each sterilization batch that is run.

Over a period of time, which could be

weeks or months, the concentration of

ethylene glycol gradually increases and

will result in less emissions reductions;

the liquor level is an indirect method of

measuring ethylene glycol

concentration. The rule states that to

exceed these parameters would violate

the emission reduction requirement. As

stated previously, we have not

established a precise relationship

between ethylene glycol concentrations

or levels and the 99 percent/1 ppmv

emission reduction requirements. On

the other hand, we have not received

data showing problems using the

ethylene glycol concentration or

scrubber level, determined during the

initial performance test, on a continuous

basis to indicate good operation (as

opposed to compliance with the specific

99 percent/1 ppmv emission reduction

requirements).

Catalytic oxidizers are used primarily

to control emissions from aeration room

vents. To ensure continuous compliance

with the emission reduction

requirements for the main sterilizer,

aeration, or chamber exhaust vent, the

promulgated rule (59 FR 62585,

December 6, 1994) requires the oxidizer

to operate at a temperature, averaged

over the sterilization cycle, above the

baseline temperature established during

the initial compliance test. This

requirement is based on the premise

that the temperature at which the

equipment operated during the initial

performance test directly correlates with

the 99 percent emission reductions

requirement under all operating

conditions. The existing requirement

also states that if the operating

temperature falls below the baseline

temperature, then the facility has

violated the 99 percent emission

reduction requirement. Again, we did

not establish the relationship between

temperature and emission reduction.

Given the fluctuations in temperature of

this batch process, it is unlikely that a

single temperature could be selected to

correlate with emissions reductions.

The basic difference between using

operating limits determined during the

initial performance test for scrubbers

and catalytic oxidizers is that catalytic

oxidizer operating limits are sensitive to

changing operating conditions during

each batch operation. Scrubber

operating limits change gradually over

many batch operations.

In the response to comments

published with the promulgated rule,

we added a specific additional test

during the final evacuation in an

attempt to establish an operating limit

valid for the full range of operating

conditions. We stated that,

‘‘Demonstration of the baseline

temperature during the last evacuation

addresses concerns that a baseline

temperature established during the first

evacuation would not be sustainable for

subsequent evacuations where the

ethylene oxide concentration is lower.’’

However, in practice we have found

that this additional test did not solve the

problem because operating temperatures

during the last evacuation, although

lower than temperatures during the first

evacuation, are typically higher than

temperatures during periods when

ethylene oxide is not being fed to the

control devices. Therefore, facilities

cannot meet either temperature

requirement on a continuous basis.

The catalytic oxidizer operates at a

design temperature of approximately

280°F when little or no ethylene oxide

is being fed to the oxidizer. During the

short periods when ethylene oxide is

introduced to the oxidizer

(approximately 10 minutes), the

13468 Federal Register / Vol. 66, No. 44 / Tuesday, March 6, 2001 / Proposed Rules

temperature spikes to about 400°F.

Therefore, the average temperature over

the sterilization cycle is between the

design temperature (280°F) and the

highest temperature (400°F). In fact, the

only temperature that can actually be

met consistently is the temperature

when little or no ethylene oxide is being

fed to the oxidizer (i.e., approximately

280°F).

The requirement to operate at the

average temperature is inconsistent with

normal operation of the equipment.

Properly operated equipment will

maintain the design temperature,

approximately 280°F, to ensure proper

combustion when ethylene oxide is

introduced to the catalyst. Short term

temperature spikes do not directly

correlate to the 99 percent emission

reduction requirement for the control

system.

B. How Are We Proposing To Amend the

Monitoring Requirements?

To correct the problems discussed in

the previous section, we are proposing

a new rule structure. There will be no

change to the emission limits. We are

proposing a different workable approach

for ensuring continuous compliance. We

will maintain the 99 percent emission

reduction requirement and measure

compliance only through performance

testing during the first evacuation. An

initial performance test is still required;

facilities that have performed this test

need not repeat the test. (Note that

enforcement agencies can always

request another test at a later date if they

choose.)

We have decided the only practical

way to ensure continuous compliance of

catalytic control devices is to establish

two requirements. One concerns catalyst

replacement to ensure that the catalyst

remains active. The other concerns

maintaining a minimum temperature to

ensure that ethylene oxide is combusted

when it passes through the catalytic

oxidizer.

First, to ensure that the catalyst

remains active we are proposing a work

practice standard. The work practice

standard would require that facilities

periodically replace the catalyst. Failure

to perform the work practice would be

a violation of the work practice

standard.

Efficient emission destruction

depends on the catalyst being active.

Vendors advertise a 3 to 5 year catalyst

life after which performance may

decline. Therefore, to ensure proper

combustion, we are proposing that

facilities replace the catalyst every 2

years.

We are proposing an operating limit

that requires facilities to maintain a

minimum design temperature

sufficiently high to ensure combustion

when ethylene oxide contacts the

catalyst. We are proposing that the

combustion device be operated at or

above the vendor-recommended

minimum design temperature.

Operating at or above the vendor

minimum design temperature would

ensure that combustion takes place but

does not require direct correlation to the

99 percent requirement.

Because we are proposing a minimum

temperature based on the vendor

minimum design temperature, we can

eliminate the existing requirement to

test the last evacuation. We originally

required a test on the last evacuation of

the main sterilizer vent because we

believed this would be a lower

‘‘average’’ temperature than that during

the first evacuation. Since we are

proposing a new approach, there is no

longer a need for this test.

We are proposing the reporting of

‘‘deviations.’’ A deviation occurs when

control equipment fails to achieve the

99 percent emission reduction during a

performance test, when one doesn’t

perform a required work practice, or

when the operating limits for

maintaining a minimum temperature are

not met.

Although we are not changing the

monitoring requirements for scrubbers,

we are proposing the removal of rule

language which states that the failure to

maintain an operating limit ‘‘shall

constitute a violation of the * * *

standard.’’ However, failure to meet

either the minimum liquor level or

ethylene glycol concentration

requirement will constitute a deviation

from the operating limit. We are

replacing the current reporting

requirements with the requirement to

report all deviations.

The current rule has two alternative

standards for aeration room vents;

facilities can demonstrate initial

compliance with either the 99 percent

emission reduction or the 1 ppmv

concentration limit. Facilities

demonstrating compliance with the 99

percent emission reduction are required

to use temperature as an operating limit.

Facilities demonstrating compliance

with the 1 ppmv concentration limit are

required to use ethylene oxide

concentration as an operating limit.

The 1 ppmv concentration limit was

based on phone conversations with

facilities operating catalytic oxidizers.

These facilities stated that their test

results showed no measurable ethylene

oxide after controls; 1 ppmv was the

lower detectable limit at the time. We

allowed an alternative 99 percent

emission reduction limit to provide a

demonstrable emission limit for

facilities which have high inlet

concentrations; in this situation, it

would not be possible to demonstrate

compliance with the 1 ppmv limit even

though the control unit was operating

efficiently. We had very limited data to

support these limits and no knowledge

that the limits are achievable under all

operating conditions.

Although ethylene oxide

concentration measurements would

indicate whether outlet concentrations

are above or below 1 ppmv, it would not

indicate proper operation under all

operating conditions. For this reason,

we are proposing, for facilities which

demonstrate initial compliance with the

1 ppmv concentration limit, an

operating limit that requires facilities to

maintain the vendor minimum design

temperature.

III. Testing

A. Why Are We Proposing To Change

the Testing Requirements?

Prior to promulgation of the rule in

1994, many facilities used

chlorofluorocarbons with ethylene

oxide. The current rule requires the use

of the EPA Method 18 because

chlorofluorocarbons will distort test

results. If a source is using an organic

compound along with ethylene oxide in

the sterilizer, the current Method 25A or

Performance Specification (PS) 8 test

method requirement would count the

organic constituent as ethylene oxide.

Since the industry has shifted almost

exclusively to using only ethylene

oxide, we are proposing a test method

change to a less expensive test method.

B. How are we proposing to amend the

testing requirements?

We are proposing the use of Method

25A and PS 8 as an option to avoid the

higher cost of the current test method

requirement. The affected sources

would have the option of using a flame

ionization analyzer (Method 25A or PS

8) or a gas chromatograph (Method 18

or PS 9) to measure ethylene oxide

concentration.

IV. Summary of Environmental, Energy

and Economic Impacts

There are negligible environmental,

energy, and economic impacts

associated with these amendments.

V. Administrative Requirements

A. Executive Order 12866: Regulatory

Planning and Review

Under Executive Order 12866 (58 FR

51735, October 4, 1993), we must

determine whether a proposed

regulatory action is ‘‘significant’’ and,

Federal Register / Vol. 66, No. 44 / Tuesday, March 6, 2001 / Proposed Rules 13469

therefore, subject to review by the Office

of Management and Budget (OMB) 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 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, it has been determined

that this rule is not a ‘‘significant

regulatory action’’ because none of the

listed criteria apply to this action.

Consequently, this action was not

submitted to OMB for review under

Executive Order 12866.

B. Paperwork Reduction Act

The information collection

requirements of the EO NESHAP were

submitted to and approved by

Management and OMB. A copy of this

Information Collection Request (ICR)

document (OMB control number 2060–

0283) may be obtained from Ms. Sandy

Farmer by mail at the U.S.

Environmental Protection Agency,

Office of Environmental Information,

Collection Strategies Division (2822),

1200 Pennsylvania Avenue,

Washington, DC 20460, by email at

farmer.sandy@epa.gov, or by calling

(202) 260–2740. A copy may also be

downloaded off the internet at http://

www.epa.gov/icr.

Today’s action has little or no impact

on the information collection burden

estimates made previously. Today’s

action eliminates requirements for

chamber exhaust vents and clarifies

testing and monitoring requirements for

sterilization and aeration room vents.

These changes revise existing

requirements and do not impose new

additional burdens; consequently, the

ICR has not been revised.

C. 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.’’

These proposed amendments do not

have federalism implications and 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. Today’s action

eliminates requirements for chamber

exhaust vents and streamlines

requirements for monitoring and testing

which were promulgated in December

1994. There are minimal, if any, impacts

associated with this action. Thus,

Executive Order 13132 does not apply

to these proposed amendments.

D. Executive Order 13175, Consultation

and Coordination With Indian Tribal

Governments

On January 1, 2001, Executive Order

13084 was superseded by Executive

Order 13175. However, this proposed

rule was developed during the period

when Executive Order 13084 was still in

force, and so tribal considerations were

addressed under Executive Order 13084.

Development of the final rule will

address tribal considerations under

Executive Order 13175.

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 we consult with those

governments. If EPA complies by

consulting, EPA is required by

Executive Order 13084 to provide to the

OMB in a separately identified section

of the preamble to the rule, a

description of the extent of EPAs 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 proposed amendments do not

significantly or uniquely affect the

communities of Indian tribal

governments because the affected

facilities are not located on tribal lands.

Accordingly, the requirements of

Executive Order 13084 do not apply to

these proposed amendments.

E. Unfunded Mandates Reform Act of

1995

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 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 objective 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 costeffective, or least-burdensome

alternative if the Administrator

publishes with the final rule an

explanation why that alternative was

not adopted. Before the 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 proposed amendments

contain no Federal mandates for State,

local, and tribal governments or the

private sector. Instead, these proposed

amendments either eliminate or

13470 Federal Register / Vol. 66, No. 44 / Tuesday, March 6, 2001 / Proposed Rules

streamline requirements of the existing

rule. Thus, today’s proposed

amendments are not subject to the

requirements of sections 202 and 205 of

the UMRA. In addition, we have

determined that these proposed

amendments contain no regulatory

requirements that might significantly or

uniquely affect small governments

because they contain no requirements

that apply to such governments or

impose obligations upon them.

F. Regulatory Flexibility Act (RFA), as

Amended by the Small Business

Regulatory Enforcement Fairness Act of

1996 (SBREFA), 5 U.S.C. 601 et seq.

The 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 the purposes of assessing the

impacts of today’s proposed

amendments on small entities, a small

entity is defined as: (1) A small business

whose parent company has fewer than

1000 employees; (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; or (3) a

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

owned and operated and is not

dominant in its field.

We believe there will be little or no

impact on any small entities because

these proposed amendments do not

impose additional requirements but

instead either eliminate or streamline

some existing requirements of the EO

NESHAP. The Administrator certifies

that this action will not have a

significant economic impact on a

substantial number of small entities.

G. National Technology Transfer and

Advancement Act of 1995

Section 12(d) of the National

Technology Transfer and Advancement

Act (NTTAA) of 1995, (Public Law No.

104–113) (15 U.S.C. 272 note), directs

EPA to use voluntary consensus

standards 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 directs

EPA to provide Congress, through

annual reports to OMB, with

explanations when an agency does not

use available and applicable voluntary

consensus standards.

These proposed amendments do not

establish or modify technical standards

in the existing rule. The EPA believes

that the use of voluntary consensus

standards for these proposed

amendments is not necessary. These

proposed amendments do not require

sources to take substantive steps that

lend themselves to voluntary consensus

standards.

H. Executive Order 13045, Protection of

Children from Environmental Health

Risks and Safety Risks

Executive Order 13045 (62 FR 19885,

April 23, 1997) applies to any rule that

(1) is determined to be ‘‘economically

significant’’ as defined under Executive

Order 12866, and (2) concerns an

environmental health or safety risk that

EPA has reason to believe may have a

disproportionate effect on children. If

the regulatory action meets both criteria,

the Agency must evaluate the

environmental health or safety effects of

the planned rule on children and

explain why the planned regulation is

preferable to other potentially effective

and reasonable alternatives considered

by the Agency.

These proposed amendments are not

subject to Executive Order 13045

because they are not an economically

significant regulatory action as defined

by Executive Order 12866. In addition,

the EPA interprets Executive Order

13045 as applying only to those

regulatory actions that are based on

health or safety risks. These proposed

amendments are not subject to

Executive Order 13045 because they are

based on technology performance and

not on health or safety risks.

List of Subjects in 40 CFR Part 63

Environmental protection, Air

pollution control, Ethylene oxide

sterilization, Hazardous substances,

Reporting and recordkeeping

requirements.

Dated: February 28, 2001.

Christine Todd Whitman,

Administrator.

For reasons set out in the preamble,

part 63 of title 40, chapter I of the Code

of Federal Regulations is proposed to be

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. Table 1 of § 63.360 is amended by

revising the entry for ‘‘63.7(a)(2)’’ to

read as follows:

§ 63.360 Applicability.

(a) * * *

TABLE 1 OF SECTION 63.360–GENERAL PROVISIONS APPLICABILITY TO SUBPART O

Reference Applies to sources using 10 tons

in subpart O a

Applies to sources using 1 to 10

tons in subpart O a Comment

*******

63.7(a)(2) ...................................... (Yes)

*******

a–See definition.

* * * * *

3. Section 63.361 is amended by

removing the definition for ‘‘Parametric

monitoring’’ and revising the definition

for ‘‘Baseline temperature’’ to read as

follows:

§ 63.361 Definitions.

* * * * *

Baseline temperature means an

average minimum temperature at the

catalyst bed of a catalytic oxidation

control device or at the exhaust point

from the combustion chamber for a

thermal oxidation control device.

* * * * *

4. Section 63.362 is amended by:

a. Revising Table 1 of paragraph (a);

Federal Register / Vol. 66, No. 44 / Tuesday, March 6, 2001 / Proposed Rules 13471

b. Removing and reserving paragraph

(e)(1);

c. Revising paragraph (e)(2).

The revisions read as follows:

§ 63.362 Standards.

(a) * * *

TABLE 1 OF SECTION 63.362—STANDARDS FOR ETHYLENE OXIDE COMMERCIAL STERILIZERS AND FUMIGATORS

Existing and new sources Source type Sterilization chamber vent Aeration room vent Chamber exhaust vent

Source size ........................ <907 kg (<1 ton) ............... No control required; minimal recordkeeping requirements (see § 63.367(c))

≥907 kg and <9,070 kg (≥1

ton and <10 tons).

99% emission reduction

(see § 63.362(c)).

No control .......................... Maximum chamber concentration limit of 5,300

ppm prior to activation of

the chamber exhaust1

(see § 63.362(e)).

≥9,070 kg (≥10 tons) ......... 99% emission reduction

(see § 63.362(c)).

1 ppm maximum outlet

concentration or 99%

emission reduction (see

§ 63.362(d)).

Maximum chamber concentration limit of 5,300

ppm prior to activation of

the chamber exhaust1

(see § 63.362(e)).

1Affected sources may show compliance by manifolding emissions to a control device used to comply with § 63.362(c) or (d) by reducing emissions by at least 99%.

*****

(e)(1) [Reserved]

(2) Chamber exhaust vent at sources

using 1 to 10 tons or sources using 10

tons. Each owner or operator of a

sterilization source using 1 to 10 tons or

a sterilization source using 10 tons shall

limit ethylene oxide emissions from the

chamber exhaust vent to the atmosphere

to a maximum concentration of 5,300

ppmv from each chamber exhaust vent.

If the owner or operator chooses to limit

emissions to 5,300 ppmv concentration

through the use of a control device, the

owner or operator may choose either to

manifold ethylene oxide emissions from

each chamber exhaust vent to a control

device used to comply with paragraph

(c) or (d) of this section or to reduce

ethylene oxide emissions to the

atmosphere (without manifolding) to a

maximum concentration of 1 ppmv or

by at least 99 percent, whichever is less

stringent.

5. Section 63.363 is revised (including

the section heading) to read as follows:

§ 63.363 Compliance and performance

provisions.

(a)(1) The owner or operator of a

source subject to emissions standards in

§ 63.362 shall conduct an initial

performance test using the procedures

listed in § 63.7 of subpart A of this part

according to the applicability in Table 1

of § 63.360, the procedures listed in this

section, and the test methods listed in

§ 63.365.

(2) The owner or operator of all

sources subject to these emissions

standards shall complete the

performance test within 180 days after

the compliance date for the specific

source as determined in § 63.360(g).

(b) The procedures in paragraphs

(b)(1) through (3) Of this section shall be

used to determine initial compliance

with the emission limits under

§ 63.362(c), the sterilization chamber

vent standard;

(1) The owner or operator shall

determine the efficiency of control

devices used to comply with § 63.362(c)

using the test methods and procedures

in § 63.365(b). The owner or operator

shall also determine:

(2) For facilities with acid-water

scrubbers, the owner or operator shall

establish as an operating parameter

either:

(i) The maximum ethylene glycol

concentration using the procedures

described in § 63.365(e)(1); or

(ii) The maximum liquor tank level

using the procedures described in

§ 63.365(e)(2).

(3) For facilities with catalytic

oxidizers or thermal oxidizers, the

owner or operator shall establish a

baseline temperature for an operating

parameter using the procedures

described in § 63.365(f) and shall, after

the initial compliance test, comply with

the following work practice by, every 2

years, replacing the catalyst bed with

new catalyst material and conducting a

performance test using the procedures

described in § 63.365(b) or (d) as

appropriate.

(c) The procedures in paragraphs

(c)(1) through (c)(3) of this section shall

be used to determine initial compliance

with the emission limits under

§ 63.362(d), the aeration room vent

standard:

(1) The owner or operator shall

comply with either paragraph (b)(2) or

(3) of this section.

(2) Determine the concentration of

ethylene oxide emitted from the

aeration room into the atmosphere (after

any control device used to comply with

§ 63.362(d)) using the methods in

§ 63.365(c)(1); or

(3) Determine the efficiency of the

control device used to comply with

§ 63.362(d) using the test methods and

procedures in § 63.365(d)(1).

(d) The procedures in paragraphs

§ 63.363(d)(1) through (3) shall be used

to determine initial compliance with the

emission limits under § 63.362(e)(2), the

chamber exhaust vent standard for

sources using 1 to 10 tons or sources

using 10 tons:

(1) For facilities manifolding

emissions from the chamber exhaust

vent to a control device controlling

emissions from the sterilization

chamber vent, the owner or operator

shall comply with the applicable

compliance provisions for the

appropriate control technology (see

paragraphs (b)(2) and (3) of this section).

(2) For facilities controlling only

emissions from the chamber exhaust

vent with a control device, the owner or

operator shall determine the efficiency

of control devices used to comply with

§ 63.362(e)(2) using the test methods

and procedures in § 63.365(d)(2), as well

as the following:

(i) For facilities with acid-water

scrubbers, the owner or operator shall

comply with paragraph (b)(2) of this

section.

(ii) For facilities with catalytic

oxidizers or thermal oxidizers, the

owner or operator shall comply with

paragraph (b)(3) of this section.

(3) For facilities exhausting emissions

to the atmosphere, the owner or

operator shall determine the

concentration of ethylene oxide in the

sterilization chamber immediately prior

to the operation of the chamber exhaust

using the test methods and procedures

in § 63.365(c)(2).

(e) For facilities complying with the

emissions limits under section § 63.362

with a control technology other than

13472 Federal Register / Vol. 66, No. 44 / Tuesday, March 6, 2001 / Proposed Rules

acid-water scrubbers or catalytic or

thermal oxidizers, the owner or operator

of the facility shall provide to the

Administrator or delegated authority

information describing the design and

operation of the air pollution control

system including recommendations for

the operating parameters to be

monitored to indicate proper operation

and maintenance of the air pollution

control system. Based on this

information, the Administrator will

determine the operating parameter(s) to

be established during the performance

test. During the performance test

required in paragraph (a) of this section

using the methods approved in

§ 63.365(g), the owner or operator shall

determine the site-specific operating

parameter(s) approved by the

Administrator.

(f) A facility must demonstrate

continuous compliance with each

operating limit and work practice

standard required under § 63.363,

except during periods of startup and

shutdowns, according to the methods

specified in § 63.364.

6. Section 63.364 is amended by:

a. Revising paragraph (b) introductory

text;

b. Adding a sentence to the end of

paragraph (b)(2);

c. Revising paragraph (c) introductory

text;

d. Removing and reserving paragraphs

(c)(1), (2) and (3);

e. Adding a sentence to the end of

paragraph (c)(4);

f. Revising paragraph (d);

g. Revising paragraph (e); and

h. Revising paragraph (f).

The additions and revisions read as

follows:

§ 63.364 Monitoring requirements.

* * * * *

(b) For sterilization facilities

complying with § 63.363 (b) or (d)

through the use of an acid-water

scrubber, the owner or operator shall

either:

* * * * *

(2) * * * Monitoring is required

during a week only if the scrubber unit

has been operated.

(c) For sterilization facilities

complying with § 63.363(b), (c), or (d)

through the use of catalytic oxidation or

thermal oxidation, the owner or

operator shall continuously monitor and

record the oxidation temperature at the

outlet to the catalyst bed or at the

exhaust point from the thermal

combustion chamber using the

temperature monitor described in

paragraph (c)(4) of this section.

Monitoring is required only when the

oxidation unit is operated. From 15-

minute or shorter period temperature

values, a data acquisition system for the

temperature monitor shall compute and

record a daily average oxidation

temperature.

(1) [Reserved]

(2) [Reserved]

(3) [Reserved]

(4) * * * As an alternative, the

accuracy temperature monitor may be

verified in a calibrated oven (traceable

to NIST standards).

(d) For sterilization facilities

complying with § 63.363(b), (c), or (d)

through the use of a control device other

than acid-water scrubbers or catalytic or

thermal oxidizers, the owner or operator

shall monitor the parameters as

approved by the Administrator using

the methods and procedures in

§ 63.365(g).

(e) For sterilization facilities

complying with § 63.363, (c)(2), or

through the use of direct measurement

of ethylene oxide concentration, the

owner or operator shall follow

paragraph (e)(1) of this section. For

sterilization facilities complying with

§ 63.363(d)(3) through the use of direct

measurement of ethylene oxide

concentration, the owner or operator

shall follow paragraph (e)(2) of this

section.

(1) Measure and record once per hour

the ethylene oxide concentration at the

outlet to the atmosphere after any

control device according to the

procedures specified in § 63.365(c)(1).

The owner or operator shall compute

and record a 3-hour average every third

hour. The owner or operator will install,

calibrate, operate, and maintain a

monitor consistent with the

requirements of performance

specifications (PS) 8 or 9 in 40 CFR part

60, appendix B, to measure ethylene

oxide. The daily calibration

requirements of section 7.2 of PS 9 or

section 2.3 of PS 8 are required only on

days when ethylene oxide emissions are

vented to the control device.

(2) Measure and record the ethylene

oxide concentration in the sterilization

chamber immediately before the

chamber exhaust is activated according

to the procedures specified in

§ 63.365(c)(2). The owner or operator

shall install, calibrate, operate, and

maintain a monitor consistent with the

requirements of PS 8 or 9 to measure

ethylene oxide concentration. The daily

calibration requirements of section 7.2

of PS 9 or section 2.3 of PS 8 are

required only on days when the

chamber exhaust is activated. Sources

complying with PS 8 are exempt from

the relative accuracy procedures in

sections 2.4 and 3 of PS 8.

(f) For sterilization facilities

complying with § 63.363(d)(1) by

manifolding emissions from the

chamber exhaust vent to a control

device controlling emissions from

another vent type, the owner or operator

shall monitor the control device to

determine which emissions from the

chamber exhaust vent are manifolded

using the applicable monitoring

requirements in paragraphs (a) through

(e) of this section and record the

monitoring data.

7. Section 63.365 is amended by:

a. Revising paragraph (b)(1)

introductory text;

b. Revising paragraph (b)(1)(iv)(B);

c. Removing and reserving paragraph

(b)(1)((iv)(C);

d. Removing and reserving paragraph

(b)(2);

e. Revising paragraph (c);

f. Revising paragraph (d);

g. Revising paragraph (f);

h. Revising paragraph (h).

The revisions read as follows:

§ 63.365 Test methods and procedures.

* * * * *

(b) * * *

(1) First evacuation of the sterilization

chamber. These procedures shall be

performed on an empty sterilization

chamber, charged with a typical amount

of ethylene oxide, for the duration of the

first evacuation under normal operating

conditions (i.e., sterilization pressure

and temperature).

* * * * *

(iv) * * *

(A) * * *

(B) Test Method 18 or 25A, 40 CFR

part 60, appendix A (hereafter referred

to as Method 18 or 25A respectively),

shall be used to measure the

concentration of ethylene oxide.

(1) Prepare a graph of volumetric flow

rate versus time corresponding to the

period of the run cycle. Integrate the

area under the curve to determine the

volume.

(2) Calculate the mass of ethylene

oxide by using the following equation:

W CV MW

SV o =×× ×

1

106

Where:

Wo = Mass of ethylene oxide, g (lb)

C = concentration of ethylene oxide in ppmv

V = volume of gas exiting the control device

corrected to standard conditions, L (ft 3)

1/106 = correction factor LEO/106 LTOTAL GAS

(ft3

EO/106 ft3TOTAL GAS)

(3) Calculate the efficiency by the

equation in paragraph (B)(1)(v) of this

section.

(C) [Reserved]

* * * * *

Federal Register / Vol. 66, No. 44 / Tuesday, March 6, 2001 / Proposed Rules 13473

(2) [Reserved]

* * * * *

(c) Concentration determination. The

following procedures shall be used to

determine the ethylene oxide

concentration as the monitored

parameter for aeration room vents as

established in § 63.364(e)(1) and to

monitor the ethylene oxide

concentration before activation of the

chamber exhaust vents as established in

§ 63.364(e)(2).

(1) Parameter Monitoring. For

determining the ethylene oxide

concentration established in

§ 63.363(b)(2)(i), (c)(2), and (d)(2),

follow the procedures in PS 8 or PS 9

in 40 CFR part 60, appendix B. Sources

complying with PS 8 are exempt from

the relative accuracy procedures in

sections 2.4 and 3 of PS 8.

(2) Sterilization chamber prior to

activation of the chamber exhaust. For

determining the ethylene oxide

concentration established in

§ 63.363(d)(2) for the sterilization

chamber before activation of the

chamber exhaust, follow the procedures

in PS 8 or PS 9 in 40 CFR part 60,

appendix B. Sources complying with PS

8 are exempt from the relative accuracy

procedures in sections 2.4 and 3 of PS

8.

(d) Efficiency determination at the

aeration room vent and at the chamber

exhaust vent (not manifolded). The

following procedures shall be used to

determine the efficiency of a control

device used to comply with § 63.362(d)

or (e), the aeration room vent standard

or the chamber exhaust vent standards.

(1) Determine the concentration of

ethylene oxide at the inlet and outlet of

the control device using the procedures

in Test Method 18 or 25A in 40 CFR

part 60, appendix A. A test is comprised

of three 1-hour runs.

(2) Determine control device

efficiency (% Eff) using the following

equation:

% Eff = Wi − ×

W

W

o

i

100

Where:

% Eff = percent efficiency

Wi = mass flow rate into the control device

Wo = mass flow rate out of the control device

(3) Repeat the procedures in

paragraphs (d)(1) and (2) of this section

three times. The arithmetic average

percent efficiency of the three runs shall

determine the overall efficiency of the

control device.

* * * * *

(f) Determination of baseline

temperature for oxidation units. The

procedure in paragraph (f)(1) of this

section shall be used to establish the

baseline temperature required in

§ 63.363(b), (c), or (d) for catalytic

oxidation units or thermal oxidation

units.

(1) The owner or operator shall

maintain the recommended minimum

oxidation temperature provided by the

oxidation unit manufacturer.

(2)–(3) [Reserved]

* * * * *

(h) An owner or operator of a

sterilization facility seeking to

demonstrate compliance with the

standards found at § 63.362(d) or (e)

with a monitoring device or procedure

other than a gas chromatograph or a

flame ionization analyzer shall provide

to the Administrator information

describing the operation of the

monitoring device or procedure and the

parameter(s) that would indicate proper

operation and maintenance of the

device or procedure. The Administrator

may request further information and

will specify appropriate test methods

and procedures.

8. Section 63.366 is amended by

revising paragraph (a)(3) as follows:

* * * * *

§ 63.366 Reporting requirements.

(a) * * *

(3) Content and submittal dates for

excess emissions and monitoring system

performance reports. All excess

emissions and monitoring system

performance reports and all summary

reports, if required per § 63.10(e)(3)(vii)

and (viii) of subpart A of this part, shall

be delivered or postmarked or

postmarked within 30 days following

the end of each calendar half or quarter

as appropriate (see § 63.10(e)(3)(i)

through (iv) for applicability). Written

reports of exceedances, excursions, or

violations of process or control system

parameters, or operating limits, shall

include all information required in

§ 63.10(c)(5) through (13) of subpart A of

this part, as applicable in Table 1 of

§ 63.360, and information from any

calibration tests in which the

monitoring equipment is not in

compliance with PS 9 or the method

used for temperature calibration. The

written report shall also include the

name, title, and signature of the

responsible official who is certifying the

accuracy of the report. When no

exceedances, excursions, or violations

have occurred or monitoring equipment

has not been inoperative, repaired, or

adjusted, such information shall be

stated in the report.

* * * * *

9. Section 63.367 is revised to read as

follows:

§ 63.367 Recordkeeping requirements.

(a) The owner or operator of a source

subject to the emissions standards in

§ 63.362 shall comply with the

recordkeeping requirements in

§ 63.10(b) and (c) of subpart A of this

part, according to the applicability in

Table 1 of § 63.360, and in this section.

All records required to be maintained by

this subpart or a subpart referenced by

this subpart shall be maintained in such

a manner that they can be readily

accessed and are suitable for inspection.

The most recent 2 years of records shall

be retained onsite or shall be accessible

to an inspector while onsite. The

records of the preceding 3 years, where

required, may be retained offsite.

Records may be maintained in hard

copy or computer-readable form

including, but not limited to, on paper,

microfilm, computer, computer disk,

magnetic tape, or microfiche.

(b) The owners or operators of a

source using 1 to 10 tons not subject to

an emissions standard in § 63.362 shall

maintain records of ethylene oxide use

on a 12-month rolling average basis

(until the source changes its operations

to become a source subject to an

emissions standard in § 63.362).

(c) The owners or operators of a

source using less than 1 ton shall

maintain records of ethylene oxide use

on a 12-month rolling average basis

(until the source changes its operations

to become a source subject to the

emissions standard in § 63.362).

[FR Doc. 01–5414 Filed 3–5–01; 8:45 am]

BILLING CODE 6560–50–P

DEPARTMENT OF ENERGY

48 CFR Parts 904, 952 and 970

RIN 1991–AB54

Acquisition Regulations; Conditional

Payment of Fee, Profit, and Other

Incentives

AGENCY: Department of Energy.

ACTION: Proposed rule; extension of

public comment period.

SUMMARY: On February 1, 2001, the

Department of Energy (DOE) published

a Notice of Proposed Rulemaking to

consider amending its Acquisition

Regulation to: implement, in part, the

requirements of Section 3147 of the

National Defense Authorization Act for

Fiscal Year 2000 relating to the

safeguarding of classified information;

establish more objective standards and

procedures for considering and applying

reductions of fee or other amounts

payable for contractor performance