27876 Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Rules and Regulations

II. Final Action

EPA is approving revisions to the

Commonwealth of Pennsylvania SIP,

which were submitted on March 6, 2000

by PADEP. These revisions will revise

25 PA Code section 129.82, Control of

VOCs from gasoline dispensing facilities

(Stage II) for Southwest Pennsylvania.

III. What Are the Administrative

Requirements?

A. General Requirements

Under Executive Order 12866 (58 FR

51735, October 4, 1993), this action is

not a ‘‘significant regulatory action’’ and

therefore is not subject to review by the

Office of Management and Budget. This

action merely approves state law as

meeting federal requirements and

imposes no additional requirements

beyond those imposed by state law.

Accordingly, the Administrator certifies

that this rule will not have a significant

economic impact on a substantial

number of small entities under the

Regulatory Flexibility Act (5 U.S.C. 601

et seq.). Because this rule approves preexisting requirements under state law

and does not impose any additional

enforceable duty beyond that required

by state law, it does not contain any

unfunded mandate or significantly or

uniquely affect small governments, as

described in the Unfunded Mandates

Reform Act of 1995 (Public Law 104–4).

This rule also does not have a

substantial direct effect on one or more

Indian tribes, on the relationship

between the Federal Government and

Indian tribes, or on the distribution of

power and responsibilities between the

Federal Government and Indian tribes,

as specified by Executive Order 13175

(65 FR 67249, November 9, 2000), nor

will it 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 (64 FR 43255,

August 10, 1999), because it merely

approves a state rule implementing a

federal standard, and does not alter the

relationship or the distribution of power

and responsibilities established in the

Clean Air Act. This rule also is not

subject to Executive Order 13045 (62 FR

19885, April 23, 1997), because it is not

economically significant.

In reviewing SIP submissions, EPA’s

role is to approve state choices,

provided that they meet the criteria of

the Clean Air Act. In this context, in the

absence of a prior existing requirement

for the State to use voluntary consensus

standards (VCS), EPA has no authority

to disapprove a SIP submission for

failure to use VCS. It would thus be

inconsistent with applicable law for

EPA, when it reviews a SIP submission,

to use VCS in place of a SIP submission

that otherwise satisfies the provisions of

the Clean Air Act. Thus, the

requirements of section 12(d) of the

National Technology Transfer and

Advancement Act of 1995 (15 U.S.C.

272 note) do not apply. As required by

section 3 of Executive Order 12988 (61

FR 4729, February 7, 1996), in issuing

this rule, EPA has taken the necessary

steps to eliminate drafting errors and

ambiguity, minimize potential litigation,

and provide a clear legal standard for

affected conduct. EPA has complied

with Executive Order 12630 (53 FR

8859, March 15, 1988) by examining the

takings implications of the rule in

accordance with the ‘‘Attorney

General’s Supplemental Guidelines for

the Evaluation of Risk and Avoidance of

Unanticipated Takings’ issued under the

executive order. This rule does not

impose an information collection

burden under the provisions of the

Paperwork Reduction Act of 1995 (44

U.S.C. 3501 et seq.).

B. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of the rule in

the Federal Register. This rule is not a

‘‘major rule’’ as defined by 5 U.S.C.

804(2).

C. Petitions for Judicial Review

Under section 307(b)(1) of the Clean

Air Act, petitions for judicial review of

this action must be filed in the United

States Court of Appeals for the

appropriate circuit by July 20, 2001.

Filing a petition for reconsideration by

the Administrator of this final rule

approving revisions to the

Commonwealth’s Stage II regulations for

Southwest Pennsylvania does not affect

the finality of this rule for the purposes

of judicial review nor does it extend the

time within which a petition for judicial

review may be filed, and shall not

postpone the effectiveness of such rule

or action. This action may not be

challenged later in proceedings to

enforce its requirements. (See section

307(b)(2).)

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Hydrocarbons,

Incorporation by reference,

Intergovernmental relations, Ozone,

Reporting and recordkeeping

requirements.

Dated: May 1, 2001.

William C. Early,

Acting Regional Administrator, Region III.

40 CFR part 52 is amended as follows:

PART 52—[AMENDED]

1. The authority citation for part 52

continues to read as follows:

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

Subpart NN—Pennsylvania

2. Section 52.2020 is amended by

adding paragraphs (c)(153) to read as

follows:

§ 52.2020 Identification of plan.

* * * * *

(c) * * *

(153) Revisions to the Commonwealth

of Pennsylvania Regulations pertaining

to Stage II VOC control requirements for

Southwest Pennsylvania submitted on

March 6, 2000 by the Pennsylvania

Department of Environmental

Protection:

(i) Incorporation by reference.

(A) Letter of March 6, 2000 from the

Pennsylvania Department of

Environmental Protection transmitting

the revisions to the Stage II VOC control

requirements for Southwest

Pennsylvania.

(B) Revisions to 25 PA Code, Chapter

129, Standards for Sources at section

129.82, Control of VOCs from gasoline

dispensing facilities (Stage II). These

revisions became effective on April 10,

1999.

(ii) Additional Material—Remainder

of March 6, 2000 submittal.

[FR Doc. 01–12574 Filed 5–18–01; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 63

[FRL–6978–5]

RIN 2060–AF30

National Emission Standards for

Hazardous Air Pollutants:

Manufacturing of Nutritional Yeast

AGENCY: Environmental Protection

Agency (EPA).

Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Rules and Regulations 27877

ACTION: Final rule.

SUMMARY: This action finalizes national

emission standards for hazardous air

pollutants (NESHAP) for the nutritional

yeast manufacturing source category.

The EPA has identified the nutritional

yeast manufacturing source category as

a major source of hazardous air

pollutants (HAP) emissions of

acetaldehyde. These standards

implement section 112(d) of the Clean

Air Act (CAA) by requiring all major

sources to meet HAP emission standards

reflecting the application of the

maximum achievable control

technology (MACT). These final

standards will eliminate approximately

13 percent of nationwide acetaldehyde

emissions from these sources. Acute

(short term) and chronic (long term)

inhalation exposure to acetaldehyde is

associated with adverse health effects

including irritation of the eyes, skin,

and respiratory tract. Acetaldehyde is a

potential developmental toxin and a

probable human carcinogen.

EFFECTIVE DATE: May 21, 2001.

ADDRESSES: Docket No. A–97–13

contains supporting information used in

developing the standards for the

nutritional yeast manufacturing source

category. 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.

FOR FURTHER INFORMATION CONTACT: Mr.

David W. Markwordt, Policy, Planning,

and Standards Group, 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,

electronic mail address:

markwordt.david@epa.gov.

SUPPLEMENTARY INFORMATION:

Docket. The docket is an organized

and complete file of all the information

considered by 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 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) 260–7548. 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 today’s final rule will

also be available on the WWW through

the EPA’s 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. Categories and

entities potentially affected by this

action include:

Category SICa NAICSb Regulated entities

Industry ................................... 2099 311999 Manufacturers of varieties of Saccharomyces cerevisiae nutritional yeast made for the

purpose of becoming an ingredient in dough for bread or other yeast-raised baked product, and for becoming a nutritional food additive.

aStandard Industrial Classification

b North American Industry Classification System

This table is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

regulated by this action. To determine

whether your facility is regulated by this

action, you should examine the

applicability criteria in § 63.2131 of the

final rule.

Judicial Review. Under section 307(b)

of the CAA, judicial review of this final

rule is available only by filing a petition

for review in the United States Court of

Appeals for the District of Columbia

Circuit by July 20, 2001. Under section

307(d)(7)(B) of the CAA, only an

objection to this rule which was raised

with reasonable specificity during the

period for public comment can be raised

during judicial review. Moreover, under

section 307(b)(2) of the CAA, the

requirements established by today’s

final action may not be challenged

separately in any civil or criminal

proceeding we bring to enforce these

requirements.

Outline. The information presented in

this preamble is organized as follows:

I. Background

A. What is the source of authority for

development of NESHAP?

B. What criteria do we use in the

development of NESHAP?

II. What are the HAP emissions and health

effects associated with the HAP emitted?

III. What are the final standards?

A. What is the source category?

B. What is the affected source?

C. What are the emission limits?

D. What are the testing and initial and

continuous compliance requirements?

E. What are the notification, recordkeeping,

and reporting requirements?

IV. What major changes have we made to the

rule since proposal?

A. Regulation Format

B. Emission Limit Standard

C. No Wastewater Requirements

D. Brew Ethanol Monitoring

E. MACT Requirements

F. Compliance Requirements

V. What are the environmental, energy, cost,

and economic impacts?

A. What are the air quality impacts?

B. What are the non-air health,

environmental, and energy impacts?

C. What are the cost and economic

impacts?

VI. Administrative Requirements

A. Executive Order 12866, Regulator

Planning and Review

B. Executive Order 13132, Federalism

C. Executive Order 13175, Consultation

and Coordination with Indian Tribal

Governments

D. Executive Order 13045, Protection of

Children from Environmental Health

Risks and Safety Risks

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. Paperwork Reduction Act

H. National Technology Transfer and

Advancement Act

I. Congressional Review Act

I. Background

A. What Is the Source of Authority for

Development of NESHAP?

Section 112 of the CAA requires us to

list categories and subcategories of

major sources and area sources of HAP

and to establish NESHAP for the listed

source categories and subcategories.

Major sources of HAP are those that

have the potential to emit greater than

27878 Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Rules and Regulations

9 Megagrams per year (Mg/yr) (10 tons

per year (tpy)) of any one HAP or 23

Mg/yr (25 tpy) of any combination of

HAP. The ‘‘baker’s yeast

manufacturing’’ source category was

listed as a major source of HAP on the

initial source category list published in

the Federal Register on July 16, 1992

(57 FR 31576). We changed the name of

the source category to ‘‘manufacturing

of nutritional yeast’’ in order to clarify

the scope of the rule and distinguish it

as not including the regulation of

bakeries.

B. What Criteria Do We Use in the

Development of NESHAP?

Section 112 of the CAA requires that

we establish NESHAP for the control of

HAP from both new and existing major

sources. The CAA requires the NESHAP

to reflect the maximum degree of

reduction in emissions of HAP that is

achievable. This level of control is

commonly referred to as the MACT.

The MACT floor is the minimum

control level allowed for NESHAP and

is defined under section 112(d)(3) of the

CAA. In essence, the MACT floor

ensures that the standard is set at a level

that assures that all major sources

achieve the level of control at least as

stringent as that already achieved by the

better-controlled and lower-emitting

sources in each source category or

subcategory. For new sources, the

MACT floor cannot be less stringent

than the emission control that is

achieved in practice by the bestcontrolled similar source.

In developing MACT, we also

consider control options that are more

stringent than the floor. We may

establish standards more stringent than

the floor based on the consideration of

cost of achieving the emissions

reductions, any non-air quality health

and environmental impacts, and energy

impacts.

II. What Are the HAP Emissions and

Health Effects Associated With the HAP

Emitted?

The HAP emitted from the nutritional

yeast manufacturing process is

acetaldehyde. We have estimated the

annual acetaldehyde emissions from the

manufacture of nutritional yeast to be

approximately 220 Mg/yr (240 tpy).

Acetaldehyde acute (short term)

exposure is associated with irritation of

the eyes, skin, and respiratory tract.

Acute inhalation of high concentrations

of acetaldehyde can cause respiratory

paralysis and death. Animal

acetaldehyde exposure studies indicate

that acetaldehyde may also be a

developmental toxin. Rats and hamsters

with chronic (long-term) exposure to

acetaldehyde have an increased

incidence of nasal and laryngeal tumors.

Based on animal studies, we have

classified acetaldehyde as a probable

human carcinogen of low carcinogenic

hazard.

III. What Are the Final Standards?

A. What Is the Source Category?

We have defined the nutritional yeast

manufacturing source category to

include facilities that manufacture

varieties of Saccharomyces cerevisiae

(also referred to as nutritional yeast, or

baker’s yeast) that are made for the

purpose of becoming an ingredient in

dough for bread or other yeast-raised

baked products, or for becoming a

nutritional food additive intended for

consumption by humans. The

nutritional yeast manufacturing source

category does not include the

production of yeast intended for

consumption by animals (for example,

as an additive for livestock feed).

B. What Is the Affected Source?

We have defined the nutritional yeast

manufacturing affected source as

including the collection of equipment

used in the manufacture of nutritional

yeast species Saccharomyces cerevisiae.

This collection of equipment includes,

but is not limited to, fermentation

vessels (fermenters). We have not

included the collection of equipment

used in the manufacture of nutritional

yeast species Candida utilis (torula

yeast) as part of the affected source.

C. What Are the Emission Limits?

For existing and new sources, we are

requiring that you meet volatile organic

compound (VOC) emission limits as a

surrogate for acetaldehyde, which

makes up a portion of the total VOC

emitted. The emission limitations

include both VOC concentration limits

and a percent-of-batches requirement.

The concentration limits apply to each

batch; they are expressed as the VOC

concentration averaged over the

duration of a batch. The fermentation

stage of each batch determines which

one of three VOC concentration limits is

applicable to that batch. To meet the

percent-of-batches requirement, you

must ensure that at least 98 percent of

batches on a rolling 12-month average

are within-concentration batches. (We

define a ‘‘within-concentration batch’’

as a batch for which the average VOC

concentration is not higher than the

maximum concentration that is allowed

as the 98 percent emission limitation.)

D. What Are the Testing and Initial and

Continuous Compliance Requirements?

To demonstrate compliance with the

VOC emission limits specified in the

rule, we require that you monitor either

the VOC concentration in the fermenter

exhaust or the brew ethanol

concentration in the fermenter. (We

define ‘‘brew ethanol’’ as the ethanol in

the fermenter liquid.)

If you monitor brew ethanol, you

must conduct performance tests

simultaneously with brew ethanol

monitoring to establish a brew-toexhaust correlation. (The ‘‘brew-toexhaust correlation’’ is the correlation

between the concentration of ethanol in

the brew and the concentration of VOC

in the fermenter exhaust.)

If you monitor fermenter exhaust, you

must ensure that at least 98 percent of

batches over the initial compliance

period are within-concentration batches

to demonstrate initial compliance with

the emission limitations.

If you monitor brew ethanol, you

must ensure that the VOC fermenter

exhaust concentration over the period of

your performance test does not exceed

the applicable maximum concentration.

You must also have a record of the

brew-to-exhaust correlation during the

performance test while the VOC

fermenter exhaust concentration is at or

below the applicable maximum

concentration.

To demonstrate continuous

compliance with the emission

limitations, you must report the

percentage of batches that are withinconcentration batches, based on a 12-

month rolling time period. Your

continuous emission monitoring system

(CEMS) must be operated at all times

during a fermentation batch monitoring

period. If you monitor brew ethanol,

you must correlate the brew ethanol

concentration measured by the CEMS,

by testing, to the VOC concentration in

the fermenter exhaust. The brew-toexhaust correlation will determine the

brew ethanol concentration CEMS

compliance monitoring limit. You are

required to determine this correlation at

least once a year.

E. What Are the Notification,

Recordkeeping, and Reporting

Requirements?

We require owners or operators of

nutritional yeast manufacturing affected

sources to which the final rule applies

to submit the following: (1) Application

for Approval of Construction or

Reconstruction, (2) Notification of

Compliance Status, (3) Compliance

Reports, and (4) Immediate Malfunction

Reports. Additionally, if an owner or

Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Rules and Regulations 27879

operator intends to conduct a

performance evaluation or performance

test, we require notification of such

intent. Records of reported information

and other information necessary to

document compliance (e.g., records

related to malfunction, records that

show continuous compliance with

emission limits) must be maintained for

5 years.

As soon as practicable before

construction begins, you must submit an

application for approval of construction

of a new major affected source,

reconstruction of a major affected

source, or reconstruction of a major

source such that the source becomes a

major affected source subject to the rule.

You must submit a separate application

for each construction or reconstruction.

You must submit at least your name and

address, the details regarding your

intent to construct or reconstruct, the

address of the proposed construction or

reconstruction, identification of the

standard(s) that are the basis for the

application, the expected

commencement and completion of the

construction or reconstruction, the

anticipated date of startup of the source,

and the type and quantity of HAP that

are anticipated by the source.

You must provide us with a one-time

notification of compliance with the final

rule. It must describe how you are

compliant with the rule, including

results of initial compliance

determination, identification of the

method to be used to determine

continuing compliance, and description

of the air pollution control method

employed.

You must report on your continued

compliance status semiannually. This

report must include your calculated

percentage of within-concentration

batches for 12-month calculation

periods ending on each calendar month

that falls within the reporting period. If

you had a malfunction during the

reporting period and you took actions as

specified in your malfunction plan, you

must include that information in the

Compliance Report (CR).

If you have a malfunction during the

reporting period that is not specified in

your malfunction plan, you must submit

an Immediate Malfunction Report. This

report consists of a telephone call (or

facsimile (FAX) transmission) to the

Administrator within 2 working days

after starting actions that are not

included with your plan and shall

describe the actions taken during the

malfunction event, followed by a letter

within 7 working days after the end of

the event. If you intend to conduct a

performance evaluation or performance

test, you are required to submit a

notification of such intent at least 60

days prior to the evaluation or test.

IV. What Major Changes Have We

Made to the Rule Since Proposal?

In response to comments received on

the proposed standards, we made

several changes to the final rule. While

some of the changes we made were

clarifications designed to make our

intentions clearer, some of the changes

are changes to the proposed standard

requirements. The substantive

comments and/or changes and

responses made since the proposal are

summarized in the following sections.

Our complete responses to public

comments are contained in a

memorandum that can be obtained from

the docket (see ADDRESSES section).

A. Regulation Format

We have changed the regulatory

format of the rule from what was

proposed on October 19, 1998 (63 FR

55812) to improve implementation,

permitting, and enforcement of the rule.

The new format also improves the

interface with the 40 CFR part 63

General Provisions which are crossreferenced in the proposed and final

rule. Although the overall format of the

final rule differs from the format of the

proposal, unless noted in another

paragraph of this section, the

requirements are the same. We believe

that the new format increases the clarity

of the requirements and eases the

implementation burden of the rule for

both the regulated entity and enforcing

agency.

B. Emission Limit Standard

We proposed two sets of emission

limits and associated requirements for

the nutritional yeast manufacturing

source category. Both sets of emission

limits potentially represented MACT.

One set, which we referred to in the

proposal preamble as the ‘‘Reasonably

Available Control Technology (RACT)

standard,’’ relies on the concentrationbased limits used in Wisconsin’s and

Maryland’s RACT rules. The second set,

which we referred to in the proposal

preamble as the ‘‘Presumptive MACT

(PMACT) standard,’’ relies on a

production-based format, which is the

same format we considered in the 1994

PMACT.

Two commenters supported the use of

the PMACT standard option, and two

commenters supported the retention of

both options in the final rule. Two of

the commenters supported the PMACT

standard option because they objected

to the proposed RACT option’s air flow

measurement requirement and air flow

cap. One of the commenters added that

they would only support the PMACT

option if the production-linked

emission factor compliance requirement

was to be kept confidential.

One of the commenters that

recommended retaining both options in

the final rule stated that they would

prefer the RACT option over the

PMACT option if the concentration

limits were expressed in terms of

propane and the air flow limitation was

removed.

Based on comments received and

further evaluation of these two options,

we decided to adopt the RACT standard

option, without the air flow cap, in the

final rule because it offers a direct

measure of compliance, does not require

calculations based on confidential

production data, and is simpler as well

as easier to use and enforce than the

PMACT standard option. Additionally,

as noted at proposal, we have more data

to support the RACT option. We have

selected the RACT standard option

because we also believe it better reflects

existing control technology

performance, operation, and batch

emissions variability.

C. No Wastewater Requirements

At proposal, we solicited comment on

regulating wastewater and what would

constitute MACT for nutritional yeast

manufacturing facilities. We received

three comment letters that argued

against the regulation of wastewater

emissions of acetaldehyde at nutritional

yeast manufacturing facilities. Reasons

given for not regulating wastewater

emissions include that the cost of

monitoring and control of emissions of

acetaldehyde would be high, that

emissions from wastewater of

acetaldehyde are insignificant, and that

treatment might increase emissions of

other air pollutants.

Based on comments received and

further analysis of wastewater

acetaldehyde emissions from nutritional

yeast manufacturing facilities, we

concluded that the MACT floor for

wastewater emissions is no control. We

then considered going beyond the floor

and determined that non-air quality

health and environmental impacts,

energy impacts, and costs to go beyond

the floor are unreasonably high (Docket

No. A–97–13).

The amount of acetaldehyde in the

wastewater is a function of the

acetaldehyde generated during the yeast

fermentation process. Acetaldehyde is a

by-product of the fermentation process.

Emission limits on the fermentation

process result in lower air emissions

from the fermentation tanks. To achieve

the emission limits, facilities must

regulate the yeast growth by process

27880 Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Rules and Regulations

control of sugar and oxygen to the yeast.

This process control also results in

lower concentrations of acetaldehyde in

the wastewater and subsequently lower

air emissions from wastewater. Thus,

levels of acetaldehyde in wastewater are

already reduced by process changes

upstream of wastewater management

operations (which process controls

constitute MACT for those operations).

Put another way, achieving the

upstream standards also controls

acetaldehyde in wastewater. The

standard of ‘‘no control’’ in the final

rule for wastewater operations thus

means no additional control beyond that

already afforded through the upstream

standards.

Further control of wastewater

emissions is achievable through use of

add-on emission control technologies.

No such controls are currently utilized,

so that any such control would be a

beyond-the-floor standard. Given the

small concentrations of acetaldehyde

remaining in wastewater, EPA believes

any such controls would not be cost

effective. In addition, there are no nonair quality impact or energy

considerations that would suggest

adopting such beyond-the-floor controls

(which would require additional energy

to operate and generate a waste stream

for disposal). Therefore, we do not

require control of emissions of

acetaldehyde from wastewater in the

final rule.

D. Brew Ethanol Monitoring

One commenter requested that the

measurement of ethanol in fermenter

liquid be allowed as an alternative to

measurement of VOC in fermenter

offgas. The commenter supplied

information to us that indicated a strong

correlation between the brew ethanol

concentration in the fermenter liquid

and the VOC concentration in the

fermenter exhaust. Upon evaluation of

the commenter’s documentation and our

own analysis, we agreed that the

correlation between brew ethanol and

VOC concentration from the fermenter

exhaust is sufficiently strong to allow

monitoring of brew ethanol as an

alternative to monitoring VOC

concentration. Therefore, the final rule

explicitly allows for the measurement of

brew ethanol as an alternative

monitoring method.

E. MACT Requirements

Some commenters expressed that

surrogate VOC concentration limits

should be established based on what is

achievable in practice. Nutritional yeast

manufacturing facilities currently

subject to RACT standards or RACT-like

standards represent the best-controlled

sources for the nutritional yeast

manufacturing source category (Docket

No. A–97–13). Some States with RACT

or RACT-like standards apply discretion

as to whether a concentration limit that

is exceeded results in a violation of the

standard (a VOC concentration limit is

exceeded if the batch-average

concentration exceeds the specified

limit). For example, Maryland’s

continuous emissions monitoring policy

allows for one VOC concentration limit

exceedance, or occurrence, per facility

per quarter.

We did not receive any comments that

supported lowering MACT

concentration limits from RACT

concentration limits. One commenter

stated that although most batches

display batch-average VOC

concentrations below the RACT limits

due to the natural variability of the

biological process of yeast-growing,

batch-average VOC concentrations

display a bell-curve distribution. The

commenter added that because of the

bell-curve distribution of VOC

concentrations, a source needs to target

VOC concentrations well below the

RACT limit in order for the distribution

of actual concentrations to remain

below the RACT limit.

We analyzed available information for

five yeast manufacturing facilities that

are subject to Wisconsin or Maryland

RACT standards or California Bay Area

Air Quality Management District

(BAAQMD) RACT-like concentration

limits. Based on our analysis, we found

that these facilities had concentration

limits that were exceeded for 0 to 2.5

percent of their runs, with an average of

1.3 percent of the concentration limits

being exceeded for the total number of

runs in 1998. Only one facility had no

concentration limits that were exceeded

(Docket No. A–97–13).

There is no evidence that failure to

meet the limit for every batch is a result

of poor operation. We do not have

sufficient data to indicate that the RACT

limits can be achieved on every batch,

so we have concluded that the MACT

floor for the nutritional yeast

manufacturing source category, for

existing and new sources, is less

stringent than meeting the RACT limits

for every batch (Docket No. A–97–13).

Therefore, we have concluded that

MACT is the control of 98 percent of the

batches to either at or below the VOC

concentration limits specified in the

rule.

F. Compliance Requirements

Many comments were received

regarding compliance requirements.

Some commenters requested that the

final rule clarify the compliance period

over which the concentration limits are

to be met. Other commenters stated that

the proposed concentration limit for

VOC (as ethanol) under the RACT

standard option was based on an

incorrect conversion of VOC to an

ethanol basis from the propane basis

that is used in the RACT rules.

We agree that the final rule should

clarify the compliance period for which

the concentration limits must be met. As

explained above, the MACT level of

control is that 98 percent of the

nutritional yeast manufacturing batches

be lower than or equal to concentration

limits established in the rule. This level

of control was determined to be

achievable on a rolling 12-month

average basis. Therefore, the final rule

clarifies that the concentration limits are

to be met on the basis of an average of

concentrations measured over the

duration of a batch, and not on an

instantaneous basis. Ninety-eight

percent of the nutritional yeast

manufacturing batches are to be within

concentration limits on a rolling 12-

month average basis.

We proposed limits in terms of VOC

as ethanol. From information and

comments received after proposal, we

learned that the use of propanecalibrated analyzers is widespread in

the nutritional yeast manufacturing

industry, and that their use is consistent

with the RACT requirements which

represent MACT. Therefore, the final

rule expresses concentration limits

based on VOC as propane rather than as

ethanol.

V. What Are the Environmental,

Energy, Cost, and Economic Impacts?

A. What Are the Air Quality Impacts?

We estimate that the 1998 nationwide

emissions from nutritional yeast

manufacturing facilities were

approximately 820 Mg/yr (900 tpy) of

VOC and 220 Mg/yr (240 tpy) of

acetaldehyde. The final rule will reduce

VOC emissions by an estimated 85 Mg/

yr (93 tpy) and acetaldehyde emissions

by an estimated 28 Mg/yr (31 tpy) from

nutritional yeast manufacturing

facilities.

B. What Are the Non-Air Health,

Environmental, and Energy Impacts?

We do not expect that there will be

any significant adverse non-air health,

environmental or energy impacts

associated with the final standards for

the nutritional yeast manufacturing

source category. We determine impacts

relative to the baseline that is set at the

level of control in absence of the rule.

The predominant control measure that

will be adopted by nutritional yeast

Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Rules and Regulations 27881

manufacturing facilities as a result of

the final rule is process control, which

will not result in any water pollution or

solid waste impacts.

C. What Are the Cost and Economic

Impacts?

The total estimated capital cost of the

final rule for the nutritional yeast

manufacturing source category is

approximately $270,000. The total

estimated annual cost of the final rule

is approximately $700,000 (Docket No.

A–97–13). We do not expect any

adverse economic impacts to result from

the final rule.

VI. Administrative Requirements

A. Executive Order 12866, Regulatory

Planning and Review

Under Executive Order 12866 (58 FR

51735, October 4, 1993), we must

determine whether the regulatory action

is ‘‘significant’’ and 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 this Executive Order.

Pursuant to the terms of Executive

Order 12866, it has been determined

that this rule is not a ‘‘significant

regulatory action’’ under the terms of

Executive Order 12866. Consequently,

this action was not submitted to OMB

for review under Executive Order

12866.

B. 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.’’ Under Executive

Order 13132, the 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 the EPA consults with

State and local officials early in the

process of developing the 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 regulation.

If the EPA complies by consulting,

Executive Order 13132 requires the 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 the 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 the EPA transmits a draft final

rule with federalism implications to

OMB for review pursuant to Executive

Order 12866, the EPA must include a

certification from the Agency’s

Federalism Official stating that the 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,

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. This final rule

is mandated by statute and does not

impose requirements on States;

however, States will be required to

implement the rule by incorporating the

rule into permits and enforcing the rule

upon delegation. States will collect

permit fees that will be used to offset

the resource burden of implementing

the rule. Thus, the requirements of

section 6 of the Executive Order do not

apply to this rule. Although section 6 of

Executive Order 13132 does not apply

to this rule, the EPA did consult with

State and local officials in developing

this rule.

C. Executive Order 13175, Consultation

and Coordination With Indian Tribal

Governments

On November 6, 2000, the President

issued Executive Order 13175 (65 FR

67249) entitled, ‘‘Consultation and

Coordination with Indian Tribal

Governments.’’ Executive Order 13175

took effect on January 6, 2001, and

revokes Executive Order 13084 (Tribal

Consultation) as of that date. The EPA

developed this final rule, however,

during the period when Executive Order

13084 was in effect; thus, EPA

addressed tribal considerations under

Executive Order 13084.

Under Executive Order 13084, the

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 the EPA complies by

consulting, Executive Order 13084

requires the EPA to provide to OMB, in

a separately identified section of the

preamble to the rule, a description of

the extent of the 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 the 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.’’

These final standards do not

significantly or uniquely affect the

communities of Indian tribal

governments. No tribal governments

own or operate nutritional yeast

manufacturing facilities. Accordingly,

the requirements of Executive Order

13084 do not apply to this action.

D. 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

27882 Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Rules and Regulations

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 rule is

preferable to other potentially effective

and reasonable alternatives considered

by the Agency.

The EPA interprets Executive Order

13045 as applying only to those

regulatory actions that are based on

health or safety risks, such that the

analysis required under section 5–501 of

the Executive Order has the potential to

influence the regulation. These final

standards are not subject to Executive

Order 13045 because they are based on

technology performance and not on

health or safety risks. No children’s risk

analysis was performed because no

alternative technologies exist that would

provide greater stringency at a

reasonable cost. Furthermore, this rule

has been determined not to be

‘‘economically significant’’ as defined

under Executive Order 12866.

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,

the EPA generally must prepare a

written statement, including a costbenefit analysis, for proposed and final

rules with ‘‘Federal mandates’’ that may

result in expenditures by State, local,

and tribal governments, in aggregate, or

by the private sector, of $100 million or

more in any 1 year. Before promulgating

an EPA rule for which a written

statement is needed, section 205 of the

UMRA generally requires EPA to

identify and consider a reasonable

number of regulatory alternatives and

adopt the least costly, most costeffective, or least burdensome

alternative that achieves the objectives

of the rule. The provisions of section

205 do not apply when they are

inconsistent with applicable law.

Moreover, section 205 allows the 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 as to 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 final rule contains no Federal

mandate that may result in expenditures

of $100 million or more for State, local,

and tribal governments, in the aggregate,

or the private sector in any 1 year. The

maximum total annual cost of this rule

for any year has been estimated to be

less than $700,000. Thus, today’s final

rule is not subject to the requirements

of sections 202 and 205 of the UMRA.

In addition, the EPA has determined

that this final rule contains no

regulatory requirements that might

significantly or uniquely affect small

governments because it contains no

regulatory requirements that apply to

such governments or impose obligations

upon them. Therefore, today’s final rule

is not subject to the requirements of

section 203 of the UMRA.

Because this final rule does not

include a Federal mandate and is

estimated to result in expenditures less

than $100 million in any 1 year by State,

local, and tribal governments, the EPA

has not prepared a budgetary impact

statement or specifically addressed the

selection of the least costly, most costeffective, or least burdensome

alternative. In addition, because small

governments will not be significantly or

uniquely affected by this rule, the EPA

is not required to develop a plan with

regard to small governments. Therefore,

the requirements of the UMRA do not

apply to this action.

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 EPA has determined that it is not

necessary to prepare a regulatory

flexibility analysis in connection with

this final rule. The EPA has also

determined that this rule will not have

a significant economic impact on a

substantial number of small entities. For

purposes of assessing the impacts of

today’s rule on small entities, a small

entity is defined as: (1) A small business

that has fewer than 500 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; and (3)

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

owned and operated and is not

dominant in its field. The small

business size standards are based on

industries as they are defined in NAICS

and were published in a final rule by

the Small Business Administration on

September 5, 2000 (65 FR 53533).

After considering the economic

impacts of today’s final rule on small

entities, EPA has concluded that this

action will not have a significant impact

on a substantial number of small

entities. Although there appears to be

one small business in the nutritional

yeast manufacturing industry, the

complex ownership issues involved

with this firm makes the absolute

determination uncertain. The EPA thus

concludes that there is at the most one

small business which may be affected

by these standards. Individual company

cost-to-sales ratio data is considered

confidential business information (CBI)

and may not be disclosed. The industry

average cost-to-sales ratio for all affected

companies is less than 0.3 percent. No

individual company is anticipated to

incur a cost-to-sales ratio exceeding 3

percent. Based on the foregoing, the

EPA concludes that this rule will not

have a significant impact on a

substantial number of small businesses.

Although this final rule will not have

a significant impact on a substantial

number of small entities, EPA

nonetheless has tried to reduce the

impact of this rule on small entities by

providing alternatives to compliance

and monitoring requirements.

G. Paperwork Reduction Act

The information collection

requirements for these final standards

will be submitted for approval to the

Office of Management and Budget under

the requirements of the Paperwork

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

An Information Collection Request (ICR)

document has been prepared by EPA

(ICR No. 1886.02) for the nutritional

yeast manufacturing source category

and copies 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, NW.,

Washington, DC 20460, by e-mail 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. The information

requirements are not effective until

OMB approves them.

The information requirements are

based on notification, recordkeeping,

and reporting requirements in the

NESHAP General Provisions (40 CFR

part 63, subpart A), which are

Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Rules and Regulations 27883

mandatory for all operators subject to

national emission standards. These

recordkeeping and reporting

requirements are specifically authorized

by section 114 of the CAA (42 U.S.C.

7414).

The final standards require owners or

operators of affected sources to retain

records for a period of 5 years. The 5-

year retention period is consistent with

the General Provisions of 40 CFR part 63

and with the 5-year record retention

requirement in the operating permit

program under title V of the CAA.

Total estimated annualized capital

monitoring, inspection, reporting and

recordkeeping (MIRR) costs for new and

existing sources is $886,307 for the first

years after promulgation of the NESHAP

for this source category. Of the total

estimated MIRR cost, $440,917 is labor

dollars and $445,390 is capital and

operation and maintenance.

The annual public reporting and

recordkeeping burden for this collection

of information (averaged over the first 3

years after the effective date of the

promulgated rule) is estimated to total

3,459 labor hours per year at a total

annual cost of $146,972. This estimate

includes notifications, performance

evaluations and tests, compliance

reports, and records of CEMS

measurements.

The total estimated annualized capital

monitoring, inspection, reporting and

recordkeeping (MIRR) costs for existing

and new major sources to comply with

the promulgated standards when an

affected source opts to comply by using

process add-on control equipment are

determined based on the estimated

capital costs of VOC monitoring

equipment required for MIRR activities.

For the yeast manufacturing industry,

the total estimated installed capital

costs of this equipment is $2,453,174 for

existing major sources, and $0 for new

major sources because we do not

anticipate construction of any new

major sources in the near future.

Annualized capital MIRR costs for

existing and new major sources to

comply with the promulgated standard

using process control were estimated to

be $89,782 and $0, respectively, when

averaged over the first 3 years after the

effective date of the promulgated rule.

The total annual estimated operating

and maintenance costs (O&M) were

calculated based on (1) the estimated

postage costs for the estimated total

annual responses associated with the

provisions of the yeast manufacturing

NESHAP and (2) the estimated annual

cost of contracting for performance

testing required for compliance with

this standard. Annual O&M costs for

existing and new major sources were

estimated to be $58,682 and $0,

respectively, when averaged over the

first 3 years after the effective date of the

promulgated rule.

Burden means the total time, effort, or

financial resources expended by persons

to generate, maintain, retain, or disclose

or provide information to or for a

Federal agency. This includes the time

needed to (1) review instructions; (2)

develop, acquire, install, and utilize

technology and systems for the purposes

of collecting, validating, and verifying

information, processing and

maintaining information, and disclosing

and providing information; (3) adjust

the existing ways to comply with any

previously applicable instructions and

requirements; (4) train personnel to be

able to respond to a collection of

information; (5) search data sources; (6)

complete and review the collection of

information; and (7) transmit or

otherwise disclose the information.

An Agency may not conduct or

sponsor, and a person is not required to

respond to, a collection of information

unless it displays a currently valid OMB

control number. The OMB control

numbers for our regulations are listed in

40 CFR part 9 and 48 CFR chapter 15.

The OMB control number(s) for the

information collection requirements in

this rule will be listed in an amendment

to 40 CFR part 9 or 48 CFR Chapter 15

in a subsequent Federal Register

document after OMB approves the ICR.

H. National Technology Transfer and

Advancement Act

Section 12(d) of the National

Technology Transfer and Advancement

Act (NTTAA) of 1995 (Public Law 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.

This rulemaking involves the

following technical standards: EPA

Methods 25A, PS 8, PS 9, and a method

for determining ethanol in liquids.

Consistent with the NTTAA, the EPA

conducted searches to identify

voluntary consensus standards in

addition to these EPA methods.

The search for emissions monitoring

procedures identified two voluntary

consensus standards, both for EPA

Method 25A. The EPA determined that

one of these two standards, (EN

12619:1999), identified for measuring

emissions of HAP or surrogates subject

to emission standards in this rule,

would not be practical due to lack of

equivalency, detail, and/or quality

assurance and/or quality control

requirements. Therefore, we did not use

this voluntary consensus standard in

this rulemaking.

The other consensus standard (ISO/

FDIS 14965) identified for EPA Method

25A is under development. Therefore,

we did not use this voluntary consensus

standard in this rulemaking. No

voluntary consensus standards were

identified for PS 8, PS 9, or a procedure

to determine ethanol in liquids. The

search and review results have been

documented and are placed in the

Docket No. A–97–13 (see ADDRESSES

section) for this rule.

Sections 63.2161 and 63.2163 of the

standards list the EPA test methods and

performance standards included in this

rulemaking. Most of the standards have

been used by States and industry for

more than 10 years.

I. Congressional Review Act

The Congressional Review Act, 5

U.S.C. 801, et seq., as added by the

Small Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. The EPA will

submit a report containing this rule and

other required information to the U.S.

Senate, the U.S. House of

Representatives, and the Comptroller

General of the United States prior to

publication of the rule in the Federal

Register. A major rule cannot take effect

until 60 days after it is published in the

Federal Register. This action is not a

‘‘major rule’’ as defined by 5 U.S.C.

804(2). This rule will be effective May

21, 2001.

List of Subjects in 40 CFR Part 63

Environmental protection,

Administrative practice and procedures,

Air emissions control, Hazardous air

pollutants, Intergovernmental relations,

Recordkeeping and reporting

requirements.

27884 Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Rules and Regulations

Dated: May 8, 2001.

Christine Todd Whitman,

Administrator.

For the reasons set out in the

preamble, title 40, chapter I, part 63, 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.

2. Part 63 is amended by adding

subpart CCCC to read as follows:

Subpart CCCC—National Emission

Standards for Hazardous Air

Pollutants: Manufacturing of

Nutritional Yeast

Sec.

What This Subpart Covers

63.2130 What is the purpose of this

subpart?

63.2131 Am I subject to this subpart?

63.2132 What parts of my plant does this

subpart cover?

63.2133 When do I have to comply with

this subpart?

Emission Limitations

63.2140 What emission limitations must I

meet?

General Compliance Requirements

63.2150 What are my general requirements

for complying with this subpart?

Testing and Initial Compliance

Requirements

63.2160 By what date must I conduct an

initial compliance demonstration?

63.2161 What performance tests and other

procedures must I use if I monitor brew

ethanol?

63.2162 When must I conduct subsequent

performance tests?

63.2163 If I monitor fermenter exhaust,

what are my monitoring installation,

operation, and maintenance

requirements?

63.2164 If I monitor brew ethanol, what are

my monitoring installation, operation,

and maintenance requirements?

63.2165 How do I demonstrate initial

compliance with the emission

limitations if I monitor fermenter

exhaust?

63.2166 How do I demonstrate initial

compliance with the emission

limitations if I monitor brew ethanol?

Continuous Compliance Requirements

63.2170 How do I monitor and collect data

to demonstrate continuous compliance?

63.2171 How do I demonstrate continuous

compliance with the emission

limitations?

Notifications, Reports, And Records

63.2180 What notifications must I submit

and when?

63.2181 What reports must I submit and

when?

63.2182 What records must I keep?

63.2183 In what form and how long must I

keep my records?

Other Requirements And Information

63.2190 What parts of the General

Provisions apply to me?

63.2191 Who implements and enforces this

subpart?

63.2192 What definitions apply to this

subpart?

Tables

Table 1 to Subpart CCCC—Emission

Limitations

Table 2 to Subpart CCCC—Requirements for

Performance Tests (Brew Ethanol

Monitoring Only)

Table 3 to Subpart CCCC—Initial Compliance

With Emission Limitations

Table 4 to Subpart CCCC—Continuous

Compliance with Emission Limitations

Table 5 to Subpart CCCC—Requirements for

Reports

Table 6 to Subpart CCCC—Applicability of

General Provisions to Subpart CCCC

What This Subpart Covers

§ 63.2130 What is the purpose of this

subpart?

This subpart establishes national

emission limitations for hazardous air

pollutants emitted from manufacturers

of nutritional yeast. This subpart also

establishes requirements to demonstrate

initial and continuous compliance with

the emission limitations.

§ 63.2131 Am I subject to this subpart?

(a) You are subject to this subpart if

you own or operate a nutritional yeast

manufacturing facility that is, is located

at, or is part of a major source of

hazardous air pollutants (HAP)

emissions.

(1) A manufacturer of nutritional

yeast is a facility that makes yeast for

the purpose of becoming an ingredient

in dough for bread or any other yeastraised baked product, or for becoming a

nutritional food additive intended for

consumption by humans. A

manufacturer of nutritional yeast does

not include production of yeast

intended for consumption by animals,

such as an additive for livestock feed.

(2) A major source of HAP emissions

is any stationary source or group of

stationary sources located within a

contiguous area and under common

control that emits or has the potential to

emit, considering controls, any single

HAP at a rate of 9.07 megagrams (10

tons) or more per year or any

combination of HAP at a rate of 22.68

megagrams (25 tons) or more per year.

(b) [Reserved]

§ 63.2132 What parts of my plant does this

subpart cover?

(a) This subpart applies to each new,

reconstructed, or existing ‘‘affected

source’’ that produces Saccharomyces

cerevisiae at a nutritional yeast

manufacturing facility.

(b) The affected source is the

collection of equipment used in the

manufacture of the nutritional yeast

species Saccharomyces cerevisiae. This

collection of equipment includes, but is

not limited to, fermentation vessels

(fermenters). The collection of

equipment used in the manufacture of

the nutritional yeast species Candida

utilis (torula yeast) is not part of the

affected source.

(c) The emission limitations in this

subpart apply to fermenters in the

affected source that meet all of the

criteria listed in paragraphs (c)(1)

through (2) of this section.

(1) The fermenters are ‘‘fed-batch’’ as

defined in § 63.2192.

(2) The fermenters are used to support

one of the last three fermentation stages

in a production run, which may be

referred to as ‘‘stock, first generation,

and trade,’’ ‘‘seed, semi-seed, and

commercial,’’ or ‘‘CB4, CB5, and CB6’’

stages.

(d) The emission limitations in this

subpart do not apply to flask, pureculture, yeasting-tank, or any other setbatch fermentation, and they do not

apply to any operations after the last

dewatering operation, such as filtration.

(e) The emission limitations in this

subpart do not apply to the affected

source during the production of

specialty yeast (defined in § 63.2192).

(f) An affected source is a ‘‘new

affected source’’ if you commenced

construction of the affected source after

October 19, 1998, and you met the

applicability criteria in § 63.2131 at the

time you commenced construction.

(g) An affected source is

‘‘reconstructed’’ if you meet the criteria

as defined in § 63.2.

(h) An affected source is ‘‘existing’’ if

it is not new or reconstructed.

§ 63.2133 When do I have to comply with

this subpart?

(a) If you have a new or reconstructed

affected source, you must comply with

paragraphs (a)(1) through (2) of this

section.

(1) If you start up your affected source

before May 21, 2001, then you must

comply with the emission limitations in

this subpart no later than May 21, 2001.

(2) If you start up your affected source

after May 21, 2001, then you must

comply with the emission limitations in

this subpart upon startup of your

affected source.

Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Rules and Regulations 27885

(b) If you have an existing affected

source, you must comply with the

emission limitations for existing sources

no later than May 21, 2004.

(c) If you have an area source that

increases its emissions, or its potential

to emit, so that it becomes a major

source of HAP, paragraphs (c)(1)

through (2) of this section apply.

(1) Any portion of the existing facility

that is a new affected source or a new

reconstructed source must be in

compliance with this subpart upon

startup.

(2) All other parts of the source must

be in compliance with this subpart by

not later than 3 years after it becomes

a major source.

(d) You must meet the notification

requirements in § 63.2180 according to

the schedule in § 63.2180 and in subpart

A of this part.

Emission Limitations

§ 63.2140 What emission limitations must I

meet?

You must meet all of the emission

limitations in Table 1 to this subpart.

General Compliance Requirements

§ 63.2150 What are my general

requirements for complying with this

subpart?

(a) You must be in compliance with

the emission limitations in Table 1 to

this subpart at all times, except during

periods of malfunction.

(b) You must always operate and

maintain your affected source, including

monitoring equipment, according to the

provisions in § 63.6(e)(1)(i). If the date

upon which you must demonstrate

initial compliance as specified in

§ 63.2160 falls after the compliance date

specified for your affected source in

§ 63.2133, then you must maintain a log

detailing the operation and maintenance

of the continuous monitoring systems

and the process and emissions control

equipment during the period between

those dates.

(c) You must develop and implement

a written malfunction plan. It will be as

specified in § 63.6(e)(3), except that the

requirements for startup, shutdown, and

maintenance plans, records and reports

apply only to malfunctions. Under this

subpart, a period of malfunction is

expressed in whole batches and not in

portions of batches.

Testing and Initial Compliance

Requirements

§ 63.2160 By what date must I conduct an

initial compliance demonstration?

(a) For each emission limitation in

Table 1 to this subpart for which

compliance is demonstrated by

monitoring fermenter exhaust, you must

demonstrate initial compliance for the

period ending on the last day of the

month that is 12 calendar months (or 11

calendar months, if the compliance date

for your source is the first day of the

month) after the compliance date that is

specified for your source in § 63.2133.

(For example, if the compliance date is

October 15, 2003, the first 12-month

period for which you must demonstrate

compliance would be October 15, 2003

through October 31, 2004.)

(b) For each emission limitation in

Table 1 to this subpart for which initial

compliance is demonstrated by

monitoring brew ethanol concentration

and calculating volatile organic

compound (VOC) concentration in the

fermenter exhaust according to the

procedures in § 63.2161, you must

demonstrate initial compliance within

180 calendar days before the

compliance date that is specified for

your source in § 63.2133.

§ 63.2161 What performance tests and

other procedures must I use if I monitor

brew ethanol?

(a) You must conduct each

performance test in Table 2 to this

subpart that applies to you.

(b) Each performance test must be

conducted according to the

requirements in § 63.7(e)(1) and under

the specific conditions that this subpart

specifies in Table 2 to this subpart and

in paragraphs (b)(1) through (4) of this

section.

(1) Conduct each performance test

simultaneously with brew ethanol

monitoring to establish a brew-toexhaust correlation equation as

specified in paragraph (f) of this section.

(2) For each fermentation stage,

conduct one run of the EPA Test

Method 25A of 40 CFR part 60,

appendix A, over the entire length of a

batch. The three fermentation stages do

not have to be from the same production

run.

(3) Do the test at a point in the

exhaust-gas stream before you inject any

dilution air, which is any air not needed

to control fermentation.

(4) Record the results of the test for

each fermentation stage.

(c) You may not conduct performance

tests during periods of startup,

shutdown, or malfunction, as specified

in § 63.7(e)(1).

(d) You must collect data to correlate

the brew ethanol concentration

measured by the continuous emission

monitoring system (CEMS) to the VOC

concentration in the fermenter exhaust

according to paragraphs (d)(1) through

(3) of this section.

(1) You must collect a separate set of

brew ethanol concentration data for

each fed-batch fermentation stage while

manufacturing the product that

comprises the largest percentage (by

mass) of average annual production.

(2) Measure brew ethanol as specified

in § 63.2164 simultaneously with

conducting a performance test for VOC

in fermenter exhaust as specified in

paragraph (b) of this section. You must

measure brew ethanol at least once

during each successive 30-minute

period over the entire period of the

performance test for VOC in fermenter

exhaust.

(3) Keep a record of the brew ethanol

concentration data for each fermentation

stage over the period of EPA Test

Method 25A of 40 CFR part 60,

appendix A, performance test when the

VOC concentration in the fermenter

exhaust does not exceed the applicable

emission limitation in Table 1 to this

subpart.

(e) For each set of data that you

collected under paragraph (d) of this

section, perform a linear regression of

brew ethanol concentration (percent) on

VOC fermenter exhaust concentration

(parts per million by volume (ppmv)

measured as propane). The correlation

between the brew ethanol concentration

as measured by the CEMS and the VOC

fermenter exhaust concentration as

measured by EPA Test Method 25A of

40 CFR part 60, appendix A, must be

linear with a correlation coefficient of at

least 0.90.

(f) Calculate the VOC concentration in

the fermenter exhaust using the brew

ethanol concentration data collected

under paragraph (d) of this section and

according to Equation 1 of this section.

BAVOC = BAE * CF + y (Eq. 1)

Where:

BAVOC = batch-average concentration of

VOC in fermenter exhaust (ppmv

measured as propane), calculated for

compliance demonstration

BAE = batch-average concentration of brew

ethanol in fermenter liquid (percent),

measured by CEMS

CF = constant established at performance test

and representing the slope of the

regression line

y = constant established at performance test

and representing the y-intercept of the

regression line

§ 63.2162 When must I conduct

subsequent performance tests?

(a) For each emission limitation in

Table 1 to this subpart for which

compliance is demonstrated by

monitoring brew ethanol concentration

and calculating VOC concentration in

the fermenter exhaust according to the

procedures in § 63.2161, you must

27886 Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Rules and Regulations

conduct an EPA Test Method 25A of 40

CFR part 60, appendix A, performance

test and establish a brew-to-exhaust

correlation according to the procedures

in Table 2 to this subpart and in

§ 63.2161, at least once every year.

(b) The first subsequent performance

test must be conducted no later than 365

calendar days after the initial

performance test conducted according

to § 63.2160. Each subsequent

performance test must be conducted no

later than 365 calendar days after the

previous performance test. You must

conduct a performance test for each 365

calendar day period for the lifetime of

the affected source.

§ 63.2163 If I monitor fermenter exhaust,

what are my monitoring installation,

operation, and maintenance requirements?

(a) Each CEMS must be installed,

operated, and maintained according to

the applicable Performance

Specification (PS) of 40 CFR part 60,

appendix B.

(b) You must conduct a performance

evaluation of each CEMS according to

the requirements in § 63.8, according to

the applicable Performance

Specification of 40 CFR part 60,

appendix B, and according to

paragraphs (b)(1) through (4) of this

section.

(1) If your CEMS monitor generates a

single combined response value for VOC

(examples of such detection principles

are flame ionization, photoionization,

and non-dispersive infrared absorption),

but it is not a flame ionization analyzer,

you must use PS 8 to show that your

CEMS is operating properly.

(i) Use EPA Test Method 25A of 40

CFR part 60, appendix A, to do the

relative-accuracy test PS 8 requires.

(ii) Calibrate the reference method

with propane.

(iii) Collect a 1-hour sample for each

reference-method test.

(2) If you continuously monitor VOC

emissions using a flame ionization

analyzer, then you must conduct the

calibration drift test PS 8 requires, but

you are not required to conduct the

relative-accuracy test PS 8 requires.

(3) If you continuously monitor VOC

emissions using gas chromatography,

you must use PS 9 of CFR part 60,

appendix B, to show that your CEMS is

operating properly.

(4) You must complete the

performance evaluation and submit the

performance evaluation report before

the compliance date that is specified for

your source in § 63.2133.

(c) Calibrate the CEMS with propane.

(d) Set the CEMS span at not greater

than 5 times the relevant emission limit,

with 1.5 to 2.5 times the relevant

emission limit being the range

considered by us to be generally

optimum.

(e) You must monitor VOC

concentration in fermenter exhaust at

any point prior to dilution of the

exhaust stream.

(f) Each CEMS must complete a

minimum of one cycle of operation

(sampling, analyzing, and data

recording) for each successive 30-

minute period within each batch

monitoring period. Except as specified

in paragraph (g) of this section, you

must have a minimum of two cycles of

operation in a 1-hour period to have a

valid hour of data.

(g) The CEMS data must be reduced

to arithmetic batch averages computed

from two or more data points over each

1-hour period, except during periods

when calibration, quality assurance, or

maintenance activities pursuant to

provisions of this part are being

performed. During these periods, a valid

hour of data shall consist of at least one

data point representing a 30-minute

period.

(h) You must have valid CEMS data

from at least 75 percent of the full hours

over the entire batch monitoring period.

(i) For each CEMS, record the results

of each inspection, calibration, and

validation check.

(j) You must check the zero (lowlevel) and high-level calibration drifts

for each CEMS in accordance with the

applicable PS of 40 CFR part 60,

appendix B. The zero (low-level) and

high-level calibration drifts shall be

adjusted, at a minimum, whenever the

zero (low-level) drift exceeds 2 times the

limits of the applicable PS. The

calibration drift checks must be

performed at least once daily except that

they may be performed less frequently

under the conditions of paragraphs (j)(1)

through (3) of this section.

(1) If a 24-hour calibration drift check

for your CEMS is performed

immediately prior to, or at the start of,

a batch monitoring period of a duration

exceeding 24 hours, you are not

required to perform 24-hour-interval

calibration drift checks during that

batch monitoring period.

(2) If the 24-hour calibration drift

exceeds 2.5 percent of the span value (or

more than 10 percent of the calibration

gas value if your CEMS is a gas

chromatograph (GC)) in fewer than 5

percent of the checks over a 1-month

period, and the 24-hour calibration drift

never exceeds 7.5 percent of the span

value, then the frequency of calibration

drift checks may be reduced to at least

weekly (once every 7 days).

(3) If, during two consecutive weekly

checks, the weekly calibration drift

exceeds 5 percent of the span value (or

more than 20 percent of the calibration

gas value, if your CEMS is a GC), then

a frequency of at least 24-hour interval

calibration checks must be resumed

until the 24-hour calibration checks

meet the test of paragraph (j)(2) of this

section.

(k) If your CEMS is out of control, you

must take corrective action according to

paragraphs (k)(1) through (3) of this

section.

(1) Your CEMS is out of control if the

zero (low-level) or high-level calibration

drift exceeds 2 times the limits of the

applicable PS.

(2) When the CEMS is out of control,

take the necessary corrective action and

repeat all necessary tests that indicate

that the system is out of control. You

must take corrective action and conduct

retesting until the performance

requirements are below the applicable

limits.

(3) During the batch monitoring

periods in which the CEMS is out of

control, recorded data shall not be used

in data averages and calculations, or to

meet any data availability requirement

established under this subpart. The

beginning of the out-of-control period is

the beginning of the first batch

monitoring period that follows the most

recent calibration drift check during

which the system was within allowable

performance limits. The end of the outof-control period is the end of the last

batch monitoring period before you

have completed corrective action and

successfully demonstrated that the

system is within the allowable limits. If

your successful demonstration that the

system is within the allowable limits

occurs during a batch monitoring

period, then the out-of-control period

ends at the end of that batch monitoring

period. If the CEMS is out of control for

any part of a particular batch monitoring

period, it is out of control for the whole

batch monitoring period.

§ 63.2164 If I monitor brew ethanol, what

are my monitoring installation, operation,

and maintenance requirements?

(a) Each CEMS must be installed,

operated, and maintained according to

manufacturer’s specifications and the

plan for malfunctions that you must

develop and use according to § 63.6(e).

(b) Each CEMS must complete a

minimum of one cycle of operation

(sampling, analyzing, and data

recording) for each successive 30-

minute period within each batch

monitoring period. Except as specified

in paragraph (c) of this section, you

must have a minimum of two cycles of

operation in a 1-hour period to have a

valid hour of data.

Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Rules and Regulations 27887

(c) The CEMS data must be reduced

to arithmetic batch averages computed

from two or more data points over each

1-hour period, except during periods

when calibration, quality assurance, or

maintenance activities pursuant to

provisions of this part are being

performed. During these periods, a valid

hour of data shall consist of at least one

data point representing a 30-minute

period.

(d) You must have valid CEMS data

from at least 75 percent of the full hours

over the entire batch monitoring period.

(e) Set the CEMS span to correspond

to not greater than 5 times the relevant

emission limit, with 1.5 to 2.5 times the

relevant emission limit being the range

considered by us to be generally

optimum. Use the brew-to-exhaust

correlation equation established under

§ 63.2161(f) to determine the span value

for your CEMS that corresponds to the

relevant emission limit.

(f) For each CEMS, record the results

of each inspection, calibration, and

validation check.

(g) The GC that you use to calibrate

your CEMS must meet the requirements

of paragraphs (g)(1) through (3) of this

section.

(1) Calibrate the GC at least daily, by

analyzing standard solutions of ethanol

in water (0.05 percent, 0.15 percent, and

0.3 percent).

(2) For use in calibrating the GC,

prepare the standard solutions of

ethanol using the procedures listed in

paragraphs (g)(2)(i) through (vi) of this

section.

(i) Starting with 100 percent ethanol,

dry the ethanol by adding a small

amount of anhydrous magnesium

sulfate (granular) to 15–20 milliliters

(ml) of ethanol.

(ii) Place approximately 50 ml of

water into a 100-ml volumetric flask and

place the flask on a balance. Tare the

balance. Weigh 2.3670 grams of the dry

(anhydrous) ethanol into the volumetric

flask.

(iii) Add the 100-ml volumetric flask

contents to a 1000-ml volumetric flask.

Rinse the 100-ml volumetric flask with

water into the 1000-ml flask. Bring the

volume to 1000 ml with water.

(iv) Place an aliquot into a sample

bottle labeled ‘‘0.3% Ethanol.’’

(v) Fill a 50-ml volumetric flask from

the contents of the 1000-ml flask. Add

the contents of the 50-ml volumetric

flask to a 100-ml volumetric flask and

rinse the 50-ml flask into the 100-ml

flask with water. Bring the volume to

100 ml with water. Place the contents

into a sample bottle labeled ‘‘0.15%

Ethanol.’’

(vi) With a 10-ml volumetric pipette,

add two 10.0-ml volumes of water to a

sample bottle labeled ‘‘0.05% Ethanol.’’

With a 10.0-ml volumetric pipette,

pipette 10.0 ml of the 0.15 percent

ethanol solution into the sample bottle

labeled ‘‘0.05% Ethanol.’’

(3) For use in calibrating the GC,

dispense samples of the standard

solutions of ethanol in water in aliquots

to appropriately labeled and dated glass

sample bottles fitted with caps having a

Teflon seal. Refrigerated samples may

be kept unopened for 1 month. Prepare

new calibration standards of ethanol in

water at least monthly.

(h) Calibrate the CEMS according to

paragraphs (h)(1) through (3) of this

section.

(1) To calibrate the CEMS, inject a

brew sample into a calibrated GC and

compare the simultaneous ethanol value

given by the CEMS to that given by the

GC. Use either the Porapak Q, 80–100

mesh, 6′ × 1⁄8′′, stainless steel packed

column or the DB Wax, 0.53 mm × 30

m capillary column.

(2) If a CEMS ethanol value differs by

20 percent or more from the

corresponding GC ethanol value,

determine the brew ethanol values

throughout the rest of the batch

monitoring period by injecting brew

samples into the GC not less frequently

than every 30 minutes. From the time at

which the difference of 20 percent or

more is detected until the batch

monitoring period ends, the GC data

will serve as the CEMS data.

(3) Perform a calibration of the CEMS

at least four times per batch.

§ 63.2165 How do I demonstrate initial

compliance with the emission limitations if

I monitor fermenter exhaust?

(a) You must demonstrate initial

compliance with each emission

limitation that applies to you according

to Table 3 to this subpart.

(b) You must submit the Notification

of Compliance Status containing the

results of the initial compliance

demonstration according to the

requirements in § 63.2180(e).

§ 63.2166 How do I demonstrate initial

compliance with the emission limitations if

I monitor brew ethanol?

(a) You must demonstrate initial

compliance with each emission

limitation that applies to you according

to Table 3 to this subpart.

(b) You must establish the brew-toexhaust correlation for each

fermentation stage according to

§ 63.2161(e).

(c) You must submit the Notification

of Compliance Status containing the

results of the initial compliance

demonstration according to the

requirements in § 63.2180(e).

Continuous Compliance Requirements

§ 63.2170 How do I monitor and collect

data to demonstrate continuous

compliance?

(a) You must monitor and collect data

according to this section.

(b) Except for monitor malfunctions,

associated repairs, and required quality

assurance or control activities

(including, as applicable, calibration

checks and required zero and span

adjustments), you must monitor

continuously during each batch

monitoring period.

(c) You may not use data recorded

during monitoring malfunctions,

associated repairs, and required quality

assurance or quality control activities in

data averages and calculations used to

report emission or operating levels, or to

fulfill a minimum data availability

requirement. You must use all the data

collected during all other periods in

assessing the operation of the control

system.

§ 63.2171 How do I demonstrate

continuous compliance with the emission

limitations?

(a) You must demonstrate continuous

compliance with each emission

limitation in Table 1 to this subpart that

applies to you according to methods

specified in Table 4 to this subpart.

(b) You must calculate the percentage

of within-concentration batches

(defined in § 63.2192) for each 12-month

period according to paragraphs (b)(1)

through (4) of this section.

(1) Determine the percentage of

batches over a 12-month calculation

period that were in compliance with the

applicable maximum concentration. The

total number of batches in the

calculation period is the sum of the

numbers of batches of each fermentation

stage for which emission limits apply.

To calculate the 12-month percentage,

do not include batches in production

during periods of malfunction. In

counting the number of batches in the

12-month calculation period, include

those batches for which the batch

monitoring period ended on or after 12

a.m. on the first day of the period and

exclude those batches for which the

batch monitoring period did not end on

or before 11:59 p.m. on the last day of

the period.

(2) You must determine the 12-month

percentage at the end of each calendar

month.

(3) The first 12-month calculation

period begins on the compliance date

that is specified for your source in

§ 63.2133 and ends on the last day of the

month that includes the date 365 days

after your compliance date, unless the

27888 Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Rules and Regulations

compliance date for your source is the

first day of the month, in which case the

first 12-month calculation period ends

on the last day of the month that is 11

calendar months after the compliance

date. (For example, if the compliance

date for your source is October 15, 2003,

the first 12-month calculation period

would begin on October 15, 2003, and

end on October 31, 2004. If the

compliance date for your source is

October 1, 2003, the first 12-month

calculation period would begin on

October 1, 2003, and end on September

30, 2004.)

(4) The second 12-month calculation

period and each subsequent 12-month

calculation period begin on the first day

of the month following the first full

month of the previous 12-month

averaging period and end on the last day

of the month 11 calendar months later.

(For example, if the compliance date for

your source is October 15, 2003, the

second calculation period would begin

on December 1, 2003 and end on

November 30, 2004.)

(c) You must report each instance

(that is, each 12-month calculation

period) in which you did not meet each

emission requirement in Table 4 to this

subpart that applies to you. (Failure of

a single batch to meet a concentration

limit does not in and of itself constitute

a failure to meet the emission

limitation.) Each instance in which you

failed to meet each applicable emission

limitation is reported as part of the

requirements in § 63.2181.

(d) During periods of malfunction,

you must operate in accordance with

the malfunction plan.

Notification, Reports, and Records

§ 63.2180 What notifications must I submit

and when?

(a) You must submit all of the

notifications in §§ 63.7(b) and (c),

63.8(e), (f)(4) and (6), and 63.9(b)

through (h) that apply to you by the

dates specified.

(b) If you start up your affected source

before May 21, 2001, you are not subject

to the initial notification requirements

of § 63.9(b)(2).

(c) If you are required to conduct a

performance test as specified in Table 2

to this subpart, you must submit a

notification of intent to conduct a

performance test at least 60 calendar

days before the performance test is

scheduled to begin as required in

§ 63.7(b)(1).

(d) If you are required to conduct a

performance evaluation as specified in

§ 63.2163(b), you must submit a

notification of the date of the

performance evaluation at least 60 days

prior to the date the performance

evaluation is scheduled to begin as

required in § 63.8(e)(2).

(e) If you are required to conduct a

performance test or other initial

compliance demonstration as specified

in Table 2 or 3 to this subpart, you must

submit a Notification of Compliance

Status according to § 63.9(h)(2)(ii) and

according to paragraphs (e)(1) through

(2) of this section.

(1) For each initial compliance

demonstration required in Table 3 to

this subpart that does not include a

performance test, you must submit the

Notification of Compliance Status no

later than July 31 or January 31,

whichever date follows the end of the

first 12 calendar months after the

compliance date that is specified for

your source in § 63.2133. If your initial

compliance demonstration does not

include a performance test, the first

compliance report, described in

§ 63.2181(b)(1), serves as the Notice of

Compliance Status.

(2) For each initial compliance

demonstration required in Table 2 or 3

to this subpart that includes a

performance test conducted according

to the requirements in Table 2, you must

submit the Notification of Compliance

Status, including the performance test

results, before the close of business on

the 60th calendar day following the

completion of the performance test

according to § 63.10(d)(2).

§ 63.2181 What reports must I submit and

when?

(a) You must submit each report in

Table 5 to this subpart that applies to

you.

(b) Unless the Administrator has

approved a different schedule for

submission of reports under § 63.10(a),

you must submit each report by the date

in Table 5 to this subpart and according

to paragraphs (b)(1) through (5) of this

section.

(1) The first compliance report must

cover the period beginning on the

compliance date that is specified for

your affected source in § 63.2133 and

ending on either June 30 or December

31 (use whichever date is the first date

following the end of the first 12

calendar months after the compliance

date that is specified for your source in

§ 63.2133). The first compliance report

must include the percentage of withinconcentration batches, as described in

§ 63.2171(b), for the first 12-month

calculation period described in

§ 63.2171(b)(3). It must also include a

percentage for each subsequent 12-

month calculation period, as described

in § 63.2171(b)(4), ending on a calendar

month that falls within the first

compliance period. (For example, if the

compliance date for your source is

October 15, 2003, the first compliance

report would cover the period from

October 15, 2003 to December 31, 2004.

It would contain percentages for the 12-

month periods ending October 31, 2004;

November 30, 2004; and December 31,

2004.)

(2) The first compliance report must

be postmarked or delivered no later than

July 31 or January 31, whichever date

follows the end of the first 12 calendar

months after the compliance date that is

specified for your affected source in

§ 63.2133.

(3) Each subsequent compliance

report must cover the semiannual

reporting period from January 1 through

June 30 or the semiannual reporting

period from July 1 through December

31. Each subsequent compliance report

must include the percentage of withinconcentration batches for each 12-

month calculation period ending on a

calendar month that falls within the

reporting period. (For example, if the

compliance date for your source is

October 15, 2003, the second

compliance report would cover the

period from January 1, 2005 through

June 30, 2005. It would contain

percentages for the 12-month periods

ending January 31, 2005; February 28,

2005; March 31, 2005; April 30, 2005;

May 31, 2005; and June 30, 2005.)

(4) Each subsequent compliance

report must be postmarked or delivered

no later than July 31 or January 31,

whichever date is the first date

following the end of the semiannual

reporting period.

(5) For each affected source that is

subject to permitting regulations

pursuant to 40 CFR part 70 or part 71,

and if the permitting authority has

established dates for submitting

semiannual reports pursuant to 40 CFR

70.6(a)(3)(a)(iii)(A) or 40 CFR

71.6(a)(3)(a)(iii)(A), you may submit the

first and subsequent compliance reports

according to the dates the permitting

authority has established instead of

according to the dates in paragraphs

(b)(1) through (4) of this section.

(c) The compliance report must

contain the information listed in

paragraphs (c)(1) through (5) of this

section.

(1) Company name and address.

(2) Statement by a responsible official

with that official’s name, title, and

signature, certifying the accuracy of the

content of the report.

(3) Date of report and beginning and

ending dates of the reporting period.

(4) Percentage of batches that are

within-concentration batches for each

12-month period ending on a calendar

Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Rules and Regulations 27889

month that falls within the reporting

period.

(5) If you had a malfunction during

the reporting period and you took

actions consistent with your

malfunction plan, the compliance report

must include the information in

§ 63.10(d)(5)(i) for each malfunction.

§ 63.2182 What records must I keep?

(a) You must keep the records listed

in paragraphs (a)(1) through (4) of this

section. These include:

(1) A copy of each notification and

report that you submitted to comply

with this subpart, including all

documentation supporting any

Notification of Compliance Status and

compliance report that you submitted,

according to the requirements in

§ 63.10(b)(2)(xiv).

(2) The records in § 63.6(e)(3)(iii)

through (v) related to malfunction;

(3) Records of performance tests and

performance evaluations as required in

§ 63.10(b)(2)(viii); and

(4) Records of results of brew-toexhaust correlation tests specified in

§ 63.2161.

(b) For each CEMS, you must keep the

records listed in paragraphs (b)(1)

through (9) of this section. These

include:

(1) Records described in

§ 63.10(b)(2)(vi);

(2) All required measurements needed

to demonstrate compliance with a

relevant standard (including, but not

limited to, 30-minute averages of CEMS

data, raw performance testing

measurements, and raw performance

evaluation measurements, that support

data that the source is required to

report);

(3) Records described in

§ 63.10(b)(2)(viii) through (xi). The

CEMS system must allow the amount of

excess zero (low-level) and high-level

calibration drift measured at the interval

checks to be quantified and recorded;

(4) All required CEMS measurements

(including monitoring data recorded

during unavoidable CEMS breakdowns

and out-of-control periods);

(5) Identification of each batch during

which the CEMS was inoperative,

except for zero (low-level) and highlevel checks;

(6) Identification of each batch during

which the CEMS was out of control, as

defined in § 63.2163(k);

(7) Previous (i.e., superseded)

versions of the performance evaluation

plan as required in § 63.8(d)(3);

(8) Request for alternatives to relative

accuracy test for CEMS as required in

§ 63.8(f)(6)(i); and

(9) Records of each batch for which

the batch-average VOC concentration

exceeded the applicable maximum VOC

concentration in Table 1 to this subpart

and whether the batch was in

production during a period of

malfunction or during another period.

(c) You must keep the records

required in Table 4 to this subpart to

show continuous compliance with each

emission limitation that applies to you.

(d) You must also keep the records

listed in paragraphs (d)(1) through (3) of

this section for each batch in your

affected source.

(1) Unique batch identification

number.

(2) Fermentation stage for which you

are using the fermenter.

(3) Unique CEMS equipment

identification number.

§ 63.2183 In what form and how long must

I keep my records?

(a) Your records must be in a form

suitable and readily available for

expeditious review, according to

§ 63.10(b)(1).

(b) As specified in § 63.10(b)(1), you

must keep each record for 5 years

following the date of each occurrence,

measurement, maintenance, corrective

action, report, or record.

(c) You must keep each record on site

for at least 2 years after the date of each

occurrence, measurement, maintenance,

corrective action, report, or record,

according to § 63.10(b)(1). You can keep

the records offsite for the remaining 3

years.

Other Requirements and Information

§ 63.2190 What parts of the General

Provisions apply to me?

Table 6 to this subpart shows which

parts of the General Provisions in

§§ 63.1 through 63.13 apply to you.

§ 63.2191 Who implements and enforces

this subpart?

(a) This subpart can be implemented

and enforced by us, the U.S. EPA, or a

delegated authority such as your State,

local, or tribal agency. If the U.S. EPA

Administrator has delegated authority to

your State, local, or tribal agency, then

that agency has the authority to

implement and enforce this subpart.

You should contact your U.S. EPA

Regional Office to find out if this

subpart is delegated to your State, local,

or tribal agency.

(b) In delegating implementation and

enforcement authority of this subpart to

a State, local, or tribal agency under 40

CFR part 63, subpart E, the authorities

contained in paragraph (c) of this

section are retained by the

Administrator of the U.S. EPA and are

not transferred to the State, local, or

tribal agency.

(c) The authorities that will not be

delegated to State, local, or tribal

agencies are as listed in paragraphs

(c)(1) through (4) of this section.

(1) Approval of alternatives to the

non-opacity emission limitations in

§ 63.2140 under § 63.6(g).

(2) Approval of major alternatives to

test methods under § 63.7(e)(2)(ii) and

(f) and as defined in § 63.90.

(3) Approval of major alternatives to

monitoring under § 63.8(f) and as

defined in § 63.90.

(4) Approval of major alternatives to

recordkeeping and reporting under

§ 63.10(f) and as defined in § 63.90.

§ 63.2192 What definitions apply to this

subpart?

Terms used in this subpart are

defined in the Clean Air Act, in 40 CFR

63.2, the General Provisions of this part,

and in this section as follows:

Batch means a single fermentation

cycle in a single fermentation vessel

(fermenter).

Batch monitoring period means the

period that begins at the later of either

the start of aeration or the addition of

yeast to the fermenter; the period ends

at the earlier of either the end of

aeration or the point at which the yeast

has begun being emptied from the

fermenter.

Brew means the mixture of yeast and

additives in the fermenter.

Brew ethanol means the ethanol in

fermenter liquid.

Brew ethanol monitor means the

monitoring system that you use to

measure brew ethanol to demonstrate

compliance with this subpart. The

monitoring system includes a resistance

element used as an ethanol sensor, with

the measured resistance proportional to

the concentration of ethanol in the

brew.

Brew-to-exhaust correlation means

the correlation between the

concentration of ethanol in the brew

and the concentration of VOC in the

fermenter exhaust. This correlation is

specific to each fed-batch fermentation

stage and is established while

manufacturing the product that

comprises the largest percentage (by

mass) of average annual production.

Emission limitation means any

emission limit or operating limit.

Fed-batch means the yeast is fed

carbohydrates and additives during

fermentation in the vessel. In contrast,

carbohydrates and additives are added

to ‘‘set-batch’’ fermenters only at the

start of the batch.

1-hour period means any 60-minute

period commencing on the minute at

which the batch monitoring period

begins.

27890 Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Rules and Regulations

Product means the yeast resulting

from the final stage in a production run.

Products are distinguished by yeast

species, strain, and variety.

Responsible official means

responsible official as defined in 40 CFR

70.2.

Specialty yeast includes but is not

limited to yeast produced for use in

wine, champagne, whiskey, and beer.

Within-concentration batch means a

batch for which the average VOC

concentration is not higher than the

maximum concentration that is allowed

as part of the applicable emission

limitation.

Tables

As stated in § 63.2140, you must

comply with the emission limitations in

the following table:

TABLE 1 TO SUBPART CCCC.—EMISSION LIMITATIONS

For each fed-batch fermenter producing yeast in the following fermentation stage . . . You must meet the following emission limitation . . .

Last stage (Trade); or Second-to-last stage (First Generation); or Thirdto-last stage (Stock).a. For at least 98 percent of all batches (sum of batches from last, second-to-last, and third-to-last stages) in each 12-month calculation period described in § 63.2171(b), the VOC concentration in the fermenter exhaust does not exceed the applicable maximum concentration (100 ppmv for last stage, 200 ppmv for second-to-last stage, or

300 ppmv for third-to-last stage), measured as propane, and averaged over the duration of a batch.

b. The emission limitation does not apply during the production of specialty yeast.

As stated in § 63.2161, if you demonstrate compliance by monitoring brew ethanol, you must comply with the

requirements for performance tests in the following table:

TABLE 2 TO SUBPART CCCC.—REQUIREMENTS FOR PERFORMANCE TESTS

[Brew Ethanol Monitoring Only]

For each fed-batch fermenter for which compliance is determined by monitoring brew ethanol

concentration and calculating VOC concentration in the fermenter exhaust according to the

procedures in § 63.2161, you must . . .

Using . . . According to the following requirements . . .

1. Measure VOC as propane ............................. Method 25A*, or an alternative validated by

EPA Method in the 301* and approved by

the Administrator.

You must measure the VOC concentration in

the fermenter exhaust at any point prior to

dilution of the exhaust stream.

2. Select the sampling port’s location and the

number of traverse points.

Method 1*

3. Measure volumetric flow rate. ........................ Method 2*

4. Perform gas analysis to determine the dry

molecular weight of the stack gas.

Method 3*

5. Determine moisture content of the stack gas Method 4*

*EPA Test Methods found in appendix A of 40 CFR part 60.

As stated in § 63.2165 (if you monitor fermenter exhaust) and § 63.2166 (if you monitor brew ethanol), you must

comply with the requirements to demonstrate initial compliance with the applicable emission limitations in the following

table:

TABLE 3 TO SUBPART CCCC.—INITIAL COMPLIANCE WITH EMISSION LIMITATIONS

For . . . For the following emission limitation . . . You have demonstrated initial compliance if

...

1. Each fed-batch fermenter producing yeast in

a fermentation stage (last Trade), second-tolast (First Generation), or third-to-last (Stock))

for which compliance is determined by monitoring VOC concentration in the fermenter exhaust.

The VOC concentration in the fermenter exhaust, averaged over the duration of the

batch, does not exceed the applicable maximum concentration (100 ppmv for last

stage, 200 ppmv for second-to-last stage,

or 300 ppmv for third-to-last stage), measured as propane..

a. You reduce the CEMS data batch averages

according to § 63.2163(g).

b. The average VOC concentration in the fermenter exhaust for at least 98 percent of

the batches (sum of batches from last, second-to-last, and third-to-last stages) during

the initial compliance period described in

§ 63.2160(a) does not exceed the applicable maximum concentration.

2. Each fed-batch fermenter producing yeast in

a fermentation stage (last (Trade), second-tolast (First Generation), or third-to-last (Stock))

for which compliance is determined by monitoring brew ethanol concentration and calculating VOC concentration in the fermenter exhaust according to the procedures in

§ 63.2161.

The VOC concentration in the fermenter exhaust, averaged over the duration of the

batch, does not exceed the applicable maximum concentration (100 ppmv for last

stage, 2000 ppmv for second-to-last stage,

or 300 ppmv for third-to-last stage), measured as propane.

a. The VOC fermenter exhaust concentration

over the period of the Method 25A* performance test does not exceed the applicable maximum concentration.

b. You have a record of the brew-to-exhaust

correlation during the Method 25A* performance test during which the VOC fermenter

exhaust concentration did not exceed the

applicable maximum concentration.

* EPA Test Method in appendix A of 40 CFR part 60.

Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Rules and Regulations 27891

As stated in § 63.2171, you must comply with the requirements to demonstrate continuous compliance with the

applicable emission limitations in the following table:

TABLE 4 TO SUBPART CCCC.—CONTINUOUS COMPLIANCE WITH EMISSION LIMITATIONS

For . . . For the following emission limitation . . . You must demonstrate continuous compliance

by . . .

1. Each fed-batch fermenter producing yeast in

a fermentation stage (last (Trade), second-tolast (First Generation), or third-to-last (Stock))

for which compliance is determined by monitoring VOC concentration in the fermenter exhaust.

For at least 98 percent of all batches (sum of

batches from last, second-to-last, and thirdto-last stages) in each 12-month calculation

period described in § 63.2171(b), the VOC

concentration in the fermenter exhaust,

averaged over the duration of the batch,

does not exceed the applicable maximum

concentration (100 ppmv for last stage, 200

ppmv for second-to-last stage, or 300 ppmv

for third-to-last stage), measured as propane.

a. Collecting the monitoring data according to

§ 63.2163(f).

b. Reducing the data according to

§ 63.2163(g).

c. For at least 98 percent of the batches (sum

of batches from last, second-to-last, and

third-to-last stages) for each 12-month period ending within a semiannual reporting

period described in § 63.2181(b)(3), the

batch average VOC concentration in the

fermenter exhaust does not exceed the applicable maximum concentration.

2. Each fed-batch fermenter producing yeast in

a fermentation stage (last (Trade), second-tolast (First Generation), or third-to-last (Stock))

for which compliance is determined by monitoring brew ethanol concentration and calculating VOC concentration in the fermenter exhaust according to the procedures in

§ 63.2161.

.For at least 98 percent of all batches (sum of

batches from last, second-to-last, and thirdto-last stages) in each 12-month calculation

period described in § 63.2171(b), the VOC

concentration in the fermenter exhaust,

averaged over the duration of the batch,

does not exceed the applicable maximum

concentration (100 ppmvc for last stage,

200 ppmv for second-to-last stage, or 300

ppmv for third-to-last stage), measured as

propane.

a. Collecting the monitoring data according to

§ 63.2164(b).

b. Reducing the data according to

§ 63.2164(c).

c. For at least 98 percent of the batches (sum

of batches from last, second-to-last, and

third-to-last stages) for each 12-month period ending within a semiannual reporting

period described in § 63.2181(b)(3), the

batch average VOC concentration in the

fermenter exhaust does not exceed the applicable maximum concentration.

As stated in § 63.2181, you must submit a compliance report that contains the information in § 63.2181(c) as well

as the information in the following table; you must also submit malfunction reports according to the requirements

in the following table:

TABLE 5 TO SUBPART CCCC.—REQUIREMENTS FOR REPORTS

You must submit a(n) The report must contain . . . You must submit the report . . .

1. Compliance report .......................................... a. Your calculated percentage of within-concentration batches, as described in

§ 63.2171(b), for 12-month calculation periods ending on each calendar month that

falls within the reporting period.

Semiannually according to the requirements

in § 63.2181(b).

b. If you had a malfunction during the reporting period and you took actions consistent

with your malfunction plan, the compliance

report must include the information in

§ 63.10(d)(5)(i).

Semiannually according to the requirements

in § 63.2181(b).

2. Immediate malfunction report if you had a

malfunction during the reporting period that is

not consistent with your malfunction plan.

a. Actions taken for the event .......................... By fax or telephone within 2 working days

after starting actions inconsistent with the

plan.

b. The information in § 63.10(d)(5)(ii) .............. By letter within 7 working days after the end

of the event unless you have made alternative arrangements with the permitting authority (§ 63.10(d)(5)(ii)).

As stated in § 63.2190, you must comply with the applicable General Provisions requirements according to the

following table:

TABLE 6 TO SUBPART CCCC.—APPLICABILITY OF GENERAL PROVISIONS TO SUBPART CCCC

Citation Subject Applicable to subpart CCCC?

§ 63.1 ................................... Applicability ..................................................................... Yes.

§ 63.2 ................................... Definitions ........................................................................ Yes.

§ 63.3 ................................... Units and Abbreviations .................................................. Yes.

§ 63.4 ................................... Prohibited Activities and Circumvention ......................... Yes.

§ 63.5 ................................... Construction and Reconstruction .................................... Yes.

§ 63.6 ................................... Compliance With Standards and Maintenance Requirements.1. For § 63.6(e) and (f), requirements for startup, shutdown, and malfunctions apply only to malfunctions.

2. § 63.6(h) does not apply.

3. Otherwise, all apply.

27892 Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Rules and Regulations

TABLE 6 TO SUBPART CCCC.—APPLICABILITY OF GENERAL PROVISIONS TO SUBPART CCCC—Continued

Citation Subject Applicable to subpart CCCC?

§ 63.7 ................................... Performance Testing Requirements ............................... 1. § 63.7(a)(1)–(2) and (e)(3) do not apply, instead

specified in this subpart.

2. Otherwise, all apply.

§ 63.8 ................................... Monitoring Requirements ................................................ 1. § 63.8(a)(2) is modified by § 63.2163.

2. § 63.8(a)(4) does not apply.

3. For § 63.8(c)(1), requirements for startup, shutdown,

and malfunctions apply only to malfunctions, and no

report pursuant to § 63.10(d)(5)(i) is required.

4. For § 63.8(d), requirements for startup, shutdown,

and malfunctions apply only to malfunctions.

5. § 63.8(c)(4)(i), (c)(5), (e)(5)(ii), and (g)(5), do not

apply.

6. § 63.8(c)(4)(ii), (c)(6)–(8), (e)(4), and (g)(1)–(4) do

not apply, instead specified in this subpart.

7. Otherwise, all apply.

§ 63.9 ................................... Notification Requirements ............................................... 1. § 63.9(b)(2) does not apply because rule omits requirements for initial notification for sources that start

up prior to May 21, 2001

2. § 63.9(f) does not apply.

3. Otherwise, all apply.

§ 63.10 ................................. Recordkeeping and Reporting Requirements ................. 1. For § 63.10(b)(2)(i)–(v), (c)(9)–(15), and (d)(5), requirements for startup, shutdown, and malfunctions

apply only to malfunctions.

2. § 63.10(b)(2)(vii) and (c)(1)–(6) do not apply, instead

specified in this subpart.

3. § 63.10(c)(7)–(8), (d)(3), (e)(2)(ii)–(4), (e)(3)–(4) do

not apply.

4. Otherwise, all apply.

§ 63.11 ................................. Flares .............................................................................. No.

§ 63.12 ................................. Delegation ....................................................................... Yes.

§ 63.13 ................................. Addresses ....................................................................... Yes.

§ 63.14 ................................. Incorporation by Reference ............................................. Yes.

§ 63.15 ................................. Availability of Information ................................................ Yes.

[FR Doc. 01–12041 Filed 5–18–01; 8:45 am]

BILLING CODE 6560–50–P

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 61

[CC Docket No. 96–262; FCC 01–146]

Access Charge Reform; Reform of

Access Charges Imposed by

Competitive Local Exchange Carriers

AGENCY: Federal Communications

Commission.

ACTION: Final rule.

SUMMARY: In this document, we limit the

application of our tariff rules to CLEC

access services in order to prevent use

of the regulatory process to impose

excessive access charges on IXCs and

their customers. Under the detariffing

regime we adopt, CLEC access rates that

are at or below the benchmark that we

set will be presumed to be just and

reasonable and CLECs may impose them

by tariff. Above the benchmark, CLEC

access services will be mandatorily

detariffed, so CLECs must negotiate

higher rates with the IXCs. We also

adopt a rural exemption to our

benchmark scheme, recognizing that a

higher level of access charges is justified

for certain CLECs serving truly rural

areas. To avoid too great a disruption for

competitive carriers, we implement the

benchmark in a way that will cause

CLEC rates to decrease over time until

they reach the rate charged by the

incumbent LEC. We also make clear that

an IXC’s refusal to serve the customers

of a CLEC that tariffs access rates within

our safe harbor, when the IXC serves

ILEC end users in the same area,

generally constitutes a violation of the

duty of all common carriers to provide

service upon reasonable request.

DATES: Effective June 20, 2001.

FOR FURTHER INFORMATION CONTACT:

Jeffrey H. Dygert, Common Carrier

Bureau, (202) 418–1500.

SUPPLEMENTARY INFORMATION: This is a

summary of the Commission’s Seventh

Report and Order in CC Docket No. 96–

262, released on April 27, 2001. The full

text of this document is available for

public inspection during regular

business hours in the FCC Reference

Center, Room CY–A257, 445 Twelfth

Street, SW., Washington, D.C., 20554.

I. Introduction

1. By this order, we seek to ensure, by

the least intrusive means possible, that

CLEC access charges are just and

reasonable. Specifically, we limit the

application of our tariff rules to CLEC

access services in order to prevent use

of the regulatory process to impose

excessive access charges on IXCs and

their customers. Previously, certain

CLECs have used the tariff system to set

access rates that were subject neither to

negotiation nor to regulation designed to

ensure their reasonableness. These

CLECs have then relied on their tariff to

demand payment from IXCs for access

services that the long distance carriers

likely would have declined to purchase

at the tariffed rate.

2. Under the detariffing regime we

adopt, CLEC access rates that are at or

below the benchmark that we set will be

presumed to be just and reasonable and

CLECs may impose them by tariff.

Above the benchmark, CLEC access

services will be mandatorily detariffed,

so CLECs must negotiate higher rates

with the IXCs. During the pendency of

negotiations, or if the parties cannot

agree, the CLEC must charge the IXC the

appropriate benchmark rate. We also

adopt a rural exemption to our