`[Federal Register Volume 66, Number 98 (Monday, May 21, 2001)]
[Rules and Regulations]
[Pages 27876-27892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12041]


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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).

[[Page 27877]]


ACTION: Final rule.

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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: [email protected].

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                     SIC\a\   NAICS\b\                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.
----------------------------------------------------------------------------------------------------------------
\a\ Standard 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 Sec. 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

[[Page 27878]]

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 best-controlled 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-to-
exhaust correlation. (The ``brew-to-exhaust 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 within-concentration 
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-to-exhaust 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

[[Page 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 
cross-referenced 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 concentration-based 
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

[[Page 27880]]

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 non-air 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 propane-
calibrated 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

[[Page 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

[[Page 27882]]

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 cost-
benefit analysis, for proposed and final rules with ``Federal 
mandates'' that may result in expenditures by State, local, and tribal 
governments, in aggregate, or by the private sector, of $100 million or 
more in any 1 year. Before promulgating an EPA rule for which a written 
statement is needed, section 205 of the UMRA generally requires EPA to 
identify and consider a reasonable number of regulatory alternatives 
and adopt the least costly, most cost-effective, or least burdensome 
alternative that achieves the objectives of the rule. The provisions of 
section 205 do not apply when they are inconsistent with applicable 
law. Moreover, section 205 allows 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 cost-effective, 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-for-profit 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 
[email protected], 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

[[Page 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.


[[Page 27884]]


    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


Sec. 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.


Sec. 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 yeast-raised 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]


Sec. 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 Sec. 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, 
pure-culture, yeasting-tank, or any other set-batch 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 
Sec. 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 Sec. 63.2131 at the time you 
commenced construction.
    (g) An affected source is ``reconstructed'' if you meet the 
criteria as defined in Sec. 63.2.
    (h) An affected source is ``existing'' if it is not new or 
reconstructed.


Sec. 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.

[[Page 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 Sec. 63.2180 
according to the schedule in Sec. 63.2180 and in subpart A of this 
part.

Emission Limitations


Sec. 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


Sec. 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 
Sec. 63.6(e)(1)(i). If the date upon which you must demonstrate initial 
compliance as specified in Sec. 63.2160 falls after the compliance date 
specified for your affected source in Sec. 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 Sec. 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


Sec. 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 
Sec. 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 
Sec. 63.2161, you must demonstrate initial compliance within 180 
calendar days before the compliance date that is specified for your 
source in Sec. 63.2133.


Sec. 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 Sec. 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-to-exhaust 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 Sec. 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 Sec. 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

Sec. 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 Sec. 63.2161, you must

[[Page 27886]]

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 Sec. 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 Sec. 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.


Sec. 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 Sec. 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 Sec. 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 (low-level) 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 out-of-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.


Sec. 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 Sec. 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.

[[Page 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 Sec. 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' 
x  \1/8\", stainless steel packed column or the DB Wax, 0.53 mm  x  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.


Sec. 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 Sec. 63.2180(e).


Sec. 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-to-exhaust correlation for each 
fermentation stage according to Sec. 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 Sec. 63.2180(e).

Continuous Compliance Requirements


Sec. 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.


Sec. 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 Sec. 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 Sec. 63.2133 and ends on the 
last day of the month that includes the date 365 days after your 
compliance date, unless the

[[Page 27888]]

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 Sec. 63.2181.
    (d) During periods of malfunction, you must operate in accordance 
with the malfunction plan.

Notification, Reports, and Records


Sec. 63.2180  What notifications must I submit and when?

    (a) You must submit all of the notifications in Secs. 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 
Sec. 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 Sec. 63.7(b)(1).
    (d) If you are required to conduct a performance evaluation as 
specified in Sec. 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 
Sec. 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 Sec. 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 
Sec. 63.2133. If your initial compliance demonstration does not include 
a performance test, the first compliance report, described in 
Sec. 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 
Sec. 63.10(d)(2).


Sec. 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 Sec. 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 
Sec. 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 
Sec. 63.2133). The first compliance report must include the percentage 
of within-concentration batches, as described in Sec. 63.2171(b), for 
the first 12-month calculation period described in Sec. 63.2171(b)(3). 
It must also include a percentage for each subsequent 12-month 
calculation period, as described in Sec. 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 Sec. 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 within-concentration 
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

[[Page 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 Sec. 63.10(d)(5)(i) for each 
malfunction.


Sec. 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 Sec. 63.10(b)(2)(xiv).
    (2) The records in Sec. 63.6(e)(3)(iii) through (v) related to 
malfunction;
    (3) Records of performance tests and performance evaluations as 
required in Sec. 63.10(b)(2)(viii); and
    (4) Records of results of brew-to-exhaust correlation tests 
specified in Sec. 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 Sec. 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 Sec. 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 high-level checks;
    (6) Identification of each batch during which the CEMS was out of 
control, as defined in Sec. 63.2163(k);
    (7) Previous (i.e., superseded) versions of the performance 
evaluation plan as required in Sec. 63.8(d)(3);
    (8) Request for alternatives to relative accuracy test for CEMS as 
required in Sec. 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.


Sec. 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 Sec. 63.10(b)(1).
    (b) As specified in Sec. 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 Sec. 63.10(b)(1). You can keep 
the records offsite for the remaining 3 years.

Other Requirements and Information


Sec. 63.2190  What parts of the General Provisions apply to me?

    Table 6 to this subpart shows which parts of the General Provisions 
in Secs. 63.1 through 63.13 apply to you.


Sec. 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 Sec. 63.2140 under Sec. 63.6(g).
    (2) Approval of major alternatives to test methods under 
Sec. 63.7(e)(2)(ii) and (f) and as defined in Sec. 63.90.
    (3) Approval of major alternatives to monitoring under Sec. 63.8(f) 
and as defined in Sec. 63.90.
    (4) Approval of major alternatives to recordkeeping and reporting 
under Sec. 63.10(f) and as defined in Sec. 63.90.


Sec. 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.

[[Page 27890]]

    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 Sec. 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      You must meet the following
              stage . . .                   emission limitation . . .
------------------------------------------------------------------------
Last stage (Trade); or Second-to-last    a. For at least 98 percent of
 stage (First Generation); or Third-to-   all batches (sum of batches
 last stage (Stock).                      from last, second-to-last, and
                                          third-to-last stages) in each
                                          12-month calculation period
                                          described in Sec.  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 Sec. 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                           According to the
     and calculating VOC           Using . . .            following
    concentration in the                             requirements . . .
 fermenter exhaust according
  to the procedures in Sec.
   63.2161, you must . . .
------------------------------------------------------------------------
1. Measure VOC as propane...  Method 25A*, or an    You must measure the
                               alternative           VOC concentration
                               validated by EPA      in the fermenter
                               Method in the 301*    exhaust at any
                               and approved by the   point prior to
                               Administrator.        dilution of the
                                                     exhaust stream.
2. Select the sampling        Method 1*             ....................
 port's location and the
 number of traverse points.
3. Measure volumetric flow    Method 2*             ....................
 rate..
4. Perform gas analysis to    Method 3*             ....................
 determine the dry molecular
 weight of the stack gas.
5. Determine moisture         Method 4*             ....................
 content of the stack gas.
------------------------------------------------------------------------
*EPA Test Methods found in appendix A of 40 CFR part 60.

    As stated in Sec. 63.2165 (if you monitor fermenter exhaust) and 
Sec. 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 the following         You have
          For . . .            emission limitation  demonstrated initial
                                      . . .          compliance if . . .
------------------------------------------------------------------------
1. Each fed-batch fermenter   The VOC               a. You reduce the
 producing yeast in a          concentration in      CEMS data batch
 fermentation stage (last      the fermenter         averages according
 Trade), second-to-last        exhaust, averaged     to Sec.
 (First Generation), or        over the duration     63.2163(g).
 third-to-last (Stock)) for    of the batch, does   b. The average VOC
 which compliance is           not exceed the        concentration in
 determined by monitoring      applicable maximum    the fermenter
 VOC concentration in the      concentration (100    exhaust for at
 fermenter exhaust.            ppmv for last         least 98 percent of
                               stage, 200 ppmv for   the batches (sum of
                               second-to-last        batches from last,
                               stage, or 300 ppmv    second-to-last, and
                               for third-to-last     third-to-last
                               stage), measured as   stages) during the
                               propane..             initial compliance
                                                     period described in
                                                     Sec.  63.2160(a)
                                                     does not exceed the
                                                     applicable maximum
                                                     concentration.
2. Each fed-batch fermenter   The VOC               a. The VOC fermenter
 producing yeast in a          concentration in      exhaust
 fermentation stage (last      the fermenter         concentration over
 (Trade), second-to-last       exhaust, averaged     the period of the
 (First Generation), or        over the duration     Method 25A*
 third-to-last (Stock)) for    of the batch, does    performance test
 which compliance is           not exceed the        does not exceed the
 determined by monitoring      applicable maximum    applicable maximum
 brew ethanol concentration    concentration (100    concentration.
 and calculating VOC           ppmv for last        b. You have a record
 concentration in the          stage, 2000 ppmv      of the brew-to-
 fermenter exhaust according   for second-to-last    exhaust correlation
 to the procedures in Sec.     stage, or 300 ppmv    during the Method
 63.2161.                      for third-to-last     25A* performance
                               stage), measured as   test during which
                               propane.              the VOC fermenter
                                                     exhaust
                                                     concentration did
                                                     not exceed the
                                                     applicable maximum
                                                     concentration.
------------------------------------------------------------------------
* EPA Test Method in appendix A of 40 CFR part 60.


[[Page 27891]]

    As stated in Sec. 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 the following   You must demonstrate
          For . . .            emission limitation       continuous
                                      . . .          compliance by . . .
------------------------------------------------------------------------
1. Each fed-batch fermenter   For at least 98       a. Collecting the
 producing yeast in a          percent of all        monitoring data
 fermentation stage (last      batches (sum of       according to Sec.
 (Trade), second-to-last       batches from last,    63.2163(f).
 (First Generation), or        second-to-last, and  b. Reducing the data
 third-to-last (Stock)) for    third-to-last         according to Sec.
 which compliance is           stages) in each 12-   63.2163(g).
 determined by monitoring      month calculation    c. For at least 98
 VOC concentration in the      period described in   percent of the
 fermenter exhaust.            Sec.  63.2171(b),     batches (sum of
                               the VOC               batches from last,
                               concentration in      second-to-last, and
                               the fermenter         third-to-last
                               exhaust, averaged     stages) for each 12-
                               over the duration     month period ending
                               of the batch, does    within a semiannual
                               not exceed the        reporting period
                               applicable maximum    described in Sec.
                               concentration (100    63.2181(b)(3), the
                               ppmv for last         batch average VOC
                               stage, 200 ppmv for   concentration in
                               second-to-last        the fermenter
                               stage, or 300 ppmv    exhaust does not
                               for third-to-last     exceed the
                               stage), measured as   applicable maximum
                               propane.              concentration.
2. Each fed-batch fermenter   .For at least 98      a. Collecting the
 producing yeast in a          percent of all        monitoring data
 fermentation stage (last      batches (sum of       according to Sec.
 (Trade), second-to-last       batches from last,    63.2164(b).
 (First Generation), or        second-to-last, and  b. Reducing the data
 third-to-last (Stock)) for    third-to-last         according to Sec.
 which compliance is           stages) in each 12-   63.2164(c).
 determined by monitoring      month calculation    c. For at least 98
 brew ethanol concentration    period described in   percent of the
 and calculating VOC           Sec.  63.2171(b),     batches (sum of
 concentration in the          the VOC               batches from last,
 fermenter exhaust according   concentration in      second-to-last, and
 to the procedures in Sec.     the fermenter         third-to-last
 63.2161.                      exhaust, averaged     stages) for each 12-
                               over the duration     month period ending
                               of the batch, does    within a semiannual
                               not exceed the        reporting period
                               applicable maximum    described in Sec.
                               concentration (100    63.2181(b)(3), the
                               ppmvc for last        batch average VOC
                               stage, 200 ppmv for   concentration in
                               second-to-last        the fermenter
                               stage, or 300 ppmv    exhaust does not
                               for third-to-last     exceed the
                               stage), measured as   applicable maximum
                               propane.              concentration.
------------------------------------------------------------------------

    As stated in Sec. 63.2181, you must submit a compliance report that 
contains the information in Sec. 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
------------------------------------------------------------------------
                                 The report must     You must submit the
    You must submit a(n)          contain . . .         report . . .
------------------------------------------------------------------------
1. Compliance report........  a. Your calculated    Semiannually
                               percentage of         according to the
                               within-               requirements in
                               concentration         Sec.  63.2181(b).
                               batches, as
                               described in Sec.
                               63.2171(b), for 12-
                               month calculation
                               periods ending on
                               each calendar month
                               that falls within
                               the reporting
                               period.
                              b. If you had a       Semiannually
                               malfunction during    according to the
                               the reporting         requirements in
                               period and you took   Sec.  63.2181(b).
                               actions consistent
                               with your
                               malfunction plan,
                               the compliance
                               report must include
                               the information in
                               Sec.  63.10(d)(5)(i
                               ).
2. Immediate malfunction      a. Actions taken for  By fax or telephone
 report if you had a           the event.            within 2 working
 malfunction during the                              days after starting
 reporting period that is                            actions
 not consistent with your                            inconsistent with
 malfunction plan.                                   the plan.
                              b. The information    By letter within 7
                               in Sec.               working days after
                               63.10(d)(5)(ii).      the end of the
                                                     event unless you
                                                     have made
                                                     alternative
                                                     arrangements with
                                                     the permitting
                                                     authority (Sec.
                                                     63.10(d)(5)(ii)).
------------------------------------------------------------------

    As stated in Sec. 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
------------------------------------------------------------------------
                                                        Applicable to
          Citation                   Subject            subpart CCCC?
------------------------------------------------------------------------
Sec.  63.1..................  Applicability.......  Yes.
Sec.  63.2..................  Definitions.........  Yes.
Sec.  63.3..................  Units and             Yes.
                               Abbreviations.
Sec.  63.4..................  Prohibited            Yes.
                               Activities and
                               Circumvention.
Sec.  63.5..................  Construction and      Yes.
                               Reconstruction.
Sec.  63.6..................  Compliance With       1. For Sec.  63.6(e)
                               Standards and         and (f),
                               Maintenance           requirements for
                               Requirements.         startup, shutdown,
                                                     and malfunctions
                                                     apply only to
                                                     malfunctions.
                                                    2. Sec.  63.6(h)
                                                     does not apply.
                                                    3. Otherwise, all
                                                     apply.

[[Page 27892]]

 
Sec.  63.7..................  Performance Testing   1. Sec.  63.7(a)(1)-
                               Requirements.         (2) and (e)(3) do
                                                     not apply, instead
                                                     specified in this
                                                     subpart.
                                                    2. Otherwise, all
                                                     apply.
Sec.  63.8..................  Monitoring            1. Sec.  63.8(a)(2)
                               Requirements.         is modified by Sec.
                                                      63.2163.
                                                    2. Sec.  63.8(a)(4)
                                                     does not apply.
                                                    3. For Sec.
                                                     63.8(c)(1),
                                                     requirements for
                                                     startup, shutdown,
                                                     and malfunctions
                                                     apply only to
                                                     malfunctions, and
                                                     no report pursuant
                                                     to Sec.
                                                     63.10(d)(5)(i) is
                                                     required.
                                                    4. For Sec.
                                                     63.8(d),
                                                     requirements for
                                                     startup, shutdown,
                                                     and malfunctions
                                                     apply only to
                                                     malfunctions.
                                                    5. Sec.
                                                     63.8(c)(4)(i),
                                                     (c)(5), (e)(5)(ii),
                                                     and (g)(5), do not
                                                     apply.
                                                    6. Sec.
                                                     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.
Sec.  63.9..................  Notification          1. Sec.  63.9(b)(2)
                               Requirements.         does not apply
                                                     because rule omits
                                                     requirements for
                                                     initial
                                                     notification for
                                                     sources that start
                                                     up prior to May 21,
                                                     2001
                                                    2. Sec.  63.9(f)
                                                     does not apply.
                                                    3. Otherwise, all
                                                     apply.
Sec.  63.10.................  Recordkeeping and     1. For Sec.
                               Reporting             63.10(b)(2)(i)-(v),
                               Requirements.         (c)(9)-(15), and
                                                     (d)(5),
                                                     requirements for
                                                     startup, shutdown,
                                                     and malfunctions
                                                     apply only to
                                                     malfunctions.
                                                    2. Sec.
                                                     63.10(b)(2)(vii)
                                                     and (c)(1)-(6) do
                                                     not apply, instead
                                                     specified in this
                                                     subpart.
                                                    3. Sec.  63.10(c)(7)-
                                                     (8), (d)(3),
                                                     (e)(2)(ii)-(4),
                                                     (e)(3)-(4) do not
                                                     apply.
                                                    4. Otherwise, all
                                                     apply.
Sec.  63.11.................  Flares..............  No.
Sec.  63.12.................  Delegation..........  Yes.
Sec.  63.13.................  Addresses...........  Yes.
Sec.  63.14.................  Incorporation by      Yes.
                               Reference.
Sec.  63.15.................  Availability of       Yes.
                               Information.
------------------------------------------------------------------------

[FR Doc. 01-12041 Filed 5-18-01; 8:45 am]
BILLING CODE 6560-50-P`